Title 12 VAC — Health

Agency 5 Department of Health

Chapter 11 Public Participation Guidelines

Part I Purpose and Definitions

12VAC5-11-10 Purpose

The purpose of this chapter is to promote public involvement in the development, amendment or repeal of the regulations of the State Board of Health. This chapter does not apply to regulations, guidelines, or other documents exempted or excluded from the provisions of the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

History

• Statutory Authority: §§ 2.2-4007.02 and 32.1-12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 4, eff. January 1, 2009.

12VAC5-11-20 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Administrative Process Act" means Chapter 40 (§ 2.2-4000 et seq.) of Title 2.2 of the Code of Virginia.

"Agency" means the State Board of Health, which is the unit of state government empowered by the agency's basic law to make regulations or decide cases. Actions specified in this chapter may be fulfilled by state employees as delegated by the agency.

"Basic law" means provisions in the Code of Virginia that delineate the basic authority and responsibilities of an agency.

"Commonwealth Calendar" means the electronic calendar for official government meetings open to the public as required by § 2.2-3707 C of the Freedom of Information Act.

''Negotiated rulemaking panel'' or ''NRP'' means an ad hoc advisory panel of interested parties established by an agency to consider issues that are controversial with the assistance of a facilitator or mediator, for the purpose of reaching a consensus in the development of a proposed regulatory action.

"Notification list" means a list used to notify persons pursuant to this chapter. Such a list may include an electronic list maintained through the Virginia Regulatory Town Hall or other list maintained by the agency.

"Open meeting" means any scheduled gathering of a unit of state government empowered by an agency's basic law to make regulations or decide cases, which is related to promulgating, amending or repealing a regulation.

"Person" means any individual, corporation, partnership, association, cooperative, limited liability company, trust, joint venture, government, political subdivision, or any other legal or commercial entity and any successor, representative, agent, agency, or instrumentality thereof.

"Public hearing" means a scheduled time at which members or staff of the agency will meet for the purpose of receiving public comment on a regulatory action.

"Regulation" means any statement of general application having the force of law, affecting the rights or conduct of any person, adopted by the agency in accordance with the authority conferred on it by applicable laws.

"Regulatory action" means the promulgation, amendment, or repeal of a regulation by the agency.

"Regulatory advisory panel" or "RAP" means a standing or ad hoc advisory panel of interested parties established by the agency for the purpose of assisting in regulatory actions.

"Town Hall" means the Virginia Regulatory Town Hall, the website operated by the Virginia Department of Planning and Budget at www.townhall.virginia.gov, which has online public comment forums and displays information about regulatory meetings and regulatory actions under consideration in Virginia and sends this information to registered public users.

"Virginia Register" means the Virginia Register of Regulations, the publication that provides official legal notice of new, amended and repealed regulations of state agencies, which is published under the provisions of Article 6 (§ 2.2-4031 et seq.) of the Administrative Process Act.

History

• Statutory Authority: §§ 2.2-4007.02 and 32.1-12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 4, eff. January 1, 2009.

Part II Notification of Interested Persons

12VAC5-11-30 Notification list

A. The agency shall maintain a list of persons who have requested to be notified of regulatory actions being pursued by the agency.

B. Any person may request to be placed on a notification list by registering as a public user on the Town Hall or by making a request to the agency. Any person who requests to be placed on a notification list shall elect to be notified either by electronic means or through a postal carrier.

C. The agency may maintain additional lists for persons who have requested to be informed of specific regulatory issues, proposals, or actions.

D. When electronic mail is returned as undeliverable on multiple occasions at least 24 hours apart, that person may be deleted from the list. A single undeliverable message is insufficient cause to delete the person from the list.

E. When mail delivered by a postal carrier is returned as undeliverable on multiple occasions, that person may be deleted from the list.

F. The agency may periodically request those persons on the notification list to indicate their desire to either continue to be notified electronically, receive documents through a postal carrier, or be deleted from the list.

History

• Statutory Authority: §§ 2.2-4007.02 and 32.1-12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 4, eff. January 1, 2009.

12VAC5-11-40 Information to be sent to persons on the notification list

A. To persons electing to receive electronic notification or notification through a postal carrier as described in 12VAC5-11-30, the agency shall send the following information:

1. A notice of intended regulatory action (NOIRA).

2. A notice of the comment period on a proposed, a reproposed, or a fast-track regulation and hyperlinks to, or instructions on how to obtain, a copy of the regulation and any supporting documents.

3. A notice soliciting comment on a final regulation when the regulatory process has been extended pursuant to § 2.2-4007.06 or 2.2-4013 C of the Code of Virginia.

B. The failure of any person to receive any notice or copies of any documents shall not affect the validity of any regulation or regulatory action.

History

• Statutory Authority: §§ 2.2-4007.02 and 32.1-12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 4, eff. January 1, 2009.

Part III Public Participation Procedures

12VAC5-11-50 Public comment

A. In considering any nonemergency, nonexempt regulatory action, the agency shall afford interested persons an opportunity to submit data, views, and arguments, either orally or in writing, to the agency. Such opportunity to comment shall include an online public comment forum on the Town Hall.

1. To any requesting person, the agency shall provide copies of the statement of basis, purpose, substance, and issues; the economic impact analysis of the proposed or fast-track regulatory action; and the agency's response to public comments received.

2. The agency may begin crafting a regulatory action prior to or during any opportunities it provides to the public to submit comments.

B. The agency shall accept public comments in writing after the publication of a regulatory action in the Virginia Register as follows:

1. For a minimum of 30 calendar days following the publication of the notice of intended regulatory action (NOIRA).

2. For a minimum of 60 calendar days following the publication of a proposed regulation.

3. For a minimum of 30 calendar days following the publication of a reproposed regulation.

4. For a minimum of 30 calendar days following the publication of a final adopted regulation.

5. For a minimum of 30 calendar days following the publication of a fast-track regulation.

6. For a minimum of 21 calendar days following the publication of a notice of periodic review.

7. Not later than 21 calendar days following the publication of a petition for rulemaking.

C. The agency may determine if any of the comment periods listed in subsection B of this section shall be extended.

D. If the Governor finds that one or more changes with substantial impact have been made to a proposed regulation, he may require the agency to provide an additional 30 calendar days to solicit additional public comment on the changes in accordance with § 2.2-4013 C of the Code of Virginia.

E. The agency shall send a draft of the agency's summary description of public comment to all public commenters on the proposed regulation at least five days before final adoption of the regulation pursuant to § 2.2-4012 E of the Code of Virginia.

History

• Statutory Authority: §§ 2.2-4007.02 and 32.1-12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 4, eff. January 1, 2009.

12VAC5-11-60 Petition for rulemaking

A. As provided in § 2.2-4007 of the Code of Virginia, any person may petition the agency to consider a regulatory action.

B. A petition shall include but is not limited to the following information:

1. The petitioner's name and contact information;

2. The substance and purpose of the rulemaking that is requested, including reference to any applicable Virginia Administrative Code sections; and

3. Reference to the legal authority of the agency to take the action requested.

C. The agency shall receive, consider and respond to a petition pursuant to § 2.2-4007 and shall have the sole authority to dispose of the petition.

D. The petition shall be posted on the Town Hall and published in the Virginia Register.

E. Nothing in this chapter shall prohibit the agency from receiving information or from proceeding on its own motion for rulemaking.

History

• Statutory Authority: §§ 2.2-4007.02 and 32.1-12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 4, eff. January 1, 2009.

12VAC5-11-70 Appointment of regulatory advisory panel

A. The agency may appoint a regulatory advisory panel (RAP) to provide professional specialization or technical assistance when the agency determines that such expertise is necessary to address a specific regulatory issue or action or when individuals indicate an interest in working with the agency on a specific regulatory issue or action.

B. Any person may request the appointment of a RAP and request to participate in its activities. The agency shall determine when a RAP shall be appointed and the composition of the RAP.

C. A RAP may be dissolved by the agency if:

1. The proposed text of the regulation is posted on the Town Hall, published in the Virginia Register, or such other time as the agency determines is appropriate; or

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act.

History

• Statutory Authority: §§ 2.2-4007.02 and 32.1-12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 4, eff. January 1, 2009.

12VAC5-11-80 Appointment of negotiated rulemaking panel

A. The agency may appoint a negotiated rulemaking panel (NRP) if a regulatory action is expected to be controversial.

B. An NRP that has been appointed by the agency may be dissolved by the agency when:

1. There is no longer controversy associated with the development of the regulation;

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act; or

3. The agency determines that resolution of a controversy is unlikely.

History

• Statutory Authority: §§ 2.2-4007.02 and 32.1-12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 4, eff. January 1, 2009.

12VAC5-11-90 Meetings

Notice of any open meeting, including meetings of a RAP or NRP, shall be posted on the Virginia Regulatory Town Hall and Commonwealth Calendar at least seven working days prior to the date of the meeting. The exception to this requirement is any meeting held in accordance with § 2.2-3707 D of the Code of Virginia allowing for contemporaneous notice to be provided to participants and the public.

History

• Statutory Authority: §§ 2.2-4007.02 and 32.1-12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 4, eff. January 1, 2009.

12VAC5-11-100 Public hearings on regulations

A. The agency shall indicate in its notice of intended regulatory action whether it plans to hold a public hearing following the publication of the proposed stage of the regulatory action.

B. The agency may conduct one or more public hearings during the comment period following the publication of a proposed regulatory action.

C. An agency is required to hold a public hearing following the publication of the proposed regulatory action when:

1. The agency's basic law requires the agency to hold a public hearing;

2. The Governor directs the agency to hold a public hearing; or

3. The agency receives requests for a public hearing from at least 25 persons during the public comment period following the publication of the notice of intended regulatory action.

D. Notice of any public hearing shall be posted on the Town Hall and Commonwealth Calendar at least seven working daysprior to the date of the hearing. The agency shall also notify those persons who requested a hearing under subdivision C 3 of this section.

History

• Statutory Authority: §§ 2.2-4007.02 and 32.1-12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 4, eff. January 1, 2009.

12VAC5-11-110 Periodic review of regulations

A. The agency shall conduct a periodic review of its regulations consistent with:

1. An executive order issued by the Governor pursuant to § 2.2-4017 of the Administrative Process Act to receive comment on all existing regulations as to their effectiveness, efficiency, necessity, clarity, and cost of compliance; and

2. The requirements in § 2.2-4007.1 of the Administrative Process Act regarding regulatory flexibility for small businesses.

B. A periodic review may be conducted separately or in conjunction with other regulatory actions.

C. Notice of a periodic review shall be posted on the Town Hall and published in the Virginia Register.

History

• Statutory Authority: §§ 2.2-4007.02 and 32.1-12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 4, eff. January 1, 2009.

Chapter 31 Virginia Emergency Medical Services Regulations

Article 1 Definitions

12VAC5-31-10 Definitions

Article 1 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise.

"Abandonment" means the termination of a health care provider-patient relationship without assurance that an equal or higher level of care meeting the assessed needs of the patient's condition is present and available.

"Accreditation" means approval granted to an entity by the Office of Emergency Medical Services (EMS) after the institution has met specific requirements enabling the institution to conduct basic or advanced life support training and education programs. There are four levels of accreditation: interim, provisional, full, and probationary.

"Accreditation cycle" means the term or cycle at the conclusion of which accreditation expires unless a full self-study is performed. Accreditation cycles are typically quinquennial (five-year) but these terms may be shorter, triennial (three-year) or biennial (two-year), if the Office of EMS deems it necessary.

"Accreditation date" means the date of the accreditation decision that is awarded to an entity following its full site visit and review.

"Accreditation decision" means the conclusion reached about an entity status after evaluation of the results of the onsite survey, recommendations of the site review team, and any other relevant information such as documentation of compliance with standards, documentation of plans to correct deficiencies, or evidence of recent improvements.

"Accreditation denied" means an accreditation decision that results when an entity has been denied accreditation. This accreditation decision becomes effective only when all available appeal procedures have been exhausted.

"Acute" means a medical condition having a rapid onset and a short duration.

"Acute care hospital" means any hospital that provides emergency medical services on a 24-hour basis.

"Administrative Process Act" or "APA" means Chapter 40 (§ 2.2-4000 et seq.) of Title 2.2 of the Code of Virginia.

"Advanced life support" or "ALS" means the provision of care by EMS personnel who are certified as an Emergency Medical Technician (EMT) - Enhanced, Advanced EMT, Intermediate, or Paramedic or equivalent as approved by the Board of Health.

Advanced life support in the air medical environment is a mission generally defined as the transport of a patient who receives care during a transport that includes an invasive medical procedure or the administration of medications, including IV infusions, in addition to any noninvasive care that is authorized by the Office of EMS.

"Advanced life support certification course" means a training program that allows a student to become eligible for a new ALS certification level. Programs must meet the educational requirements established by the Office of EMS as defined by the respective advanced life support curriculum. Initial certification courses include:

1. Emergency Medical Technician-Enhanced;

2. Advanced EMT;

3. Advanced EMT to Intermediate Bridge;

4. EMT-Enhanced to Intermediate Bridge;

5. Intermediate;

6. Intermediate to Paramedic Bridge;

7. Paramedic;

8. Registered Nurse to Paramedic Bridge; and

9. Other programs approved by the Office of EMS.

"Advanced life support coordinator" means a person who has met the criteria established by the Office of EMS to assume responsibility for conducting ALS training programs.

"Advanced life support transport" means the transportation of a patient who is receiving ALS level care.

"Affiliated" means a person who is employed by or a member of an EMS agency.

"Air medical specialist" means a person trained in the concept of flight physiology and the effects of flight on patients through documented completion of a program approved by the Office of EMS. This training must include but is not limited to aerodynamics, weather, communications, safety around aircraft/ambulances, scene safety, landing zone operations, flight physiology, equipment/aircraft familiarization, basic flight navigation, flight documentation, and survival training specific to service area.

"Ambulance" means, as defined by § 32.1-111.1 of the Code of Virginia, any vehicle, vessel or craft that holds a valid permit issued by the Office of EMS and that is specially constructed, equipped, maintained and operated, and intended to be used for emergency medical care and the transportation of patients who are sick, injured, wounded, or otherwise incapacitated or helpless. The word "ambulance" may not appear on any vehicle, vessel or aircraft that does not hold a valid EMS vehicle permit.

"Approved locking device" means a mechanism that prevents removal or opening of a drug kit by means other than securing the drug kit by the handle only.

"Assistant director" means the Assistant Director of the Office of Emergency Medical Services.

"Attendant-in-charge" or "AIC" means the certified or licensed person who is qualified and designated to be primarily responsible for the provision of emergency medical care.

"Attendant" means a certified or licensed person qualified to assist in the provision of emergency medical care.

"Basic life support" or "BLS" means the provision of care by EMS personnel who are certified as First Responder, Emergency Medical Responder (EMR), or Emergency Medical Technician or equivalent as approved by the Board of Health.

Basic life support in the air medical environment means a mission generally defined as the transport of a patient who receives care during a transport that is commensurate with the scope of practice of an EMT. In the Commonwealth of Virginia care that is provided in the air medical environment must be assumed at a minimum by a Virginia certified Paramedic who is a part of the regular air medical crew. (fixed wing excluded)

"BLS certification course" means a training program that allows a student to become eligible for a new BLS certification level. Programs must meet the educational requirements established by the Office of EMS as defined by the respective basic life support curriculum. Initial certification courses include:

1. EMS First Responder;

2. EMS First Responder Bridge to EMT;

3. Emergency Medical Responder;

4. Emergency Medical Responder Bridge to EMT;

5. Emergency Medical Technician; and

6. Other programs approved by the Office of EMS.

"Board" or "state board" means the State Board of Health.

"Candidate" means any person who is enrolled in or is taking a course leading toward initial certification.

"Candidate status" means the status awarded to a program that has made application to the Office of EMS for accreditation but that is not yet accredited.

"CDC" means the United States Centers for Disease Control and Prevention.

"Certification" means a credential issued by the Office of EMS for a specified period of time to a person who has successfully completed an approved training program.

"Certification candidate" means a person seeking EMS certification from the Office of EMS.

"Certification candidate status" means any candidate or provider who becomes eligible for certification testing but who has not yet taken the certification test using that eligibility.

"Certification examiner" means an individual designated by the Office of EMS to administer a state certification examination.

"Certification transfer" means the issuance of certification through reciprocity, legal recognition, challenge or equivalency based on prior training, certification or licensure.

"Chief executive officer" means the person authorized or designated by the agency or service as the highest in administrative rank or authority.

"Commercial mobile radio service" or "CMRS" means the same as that term is defined in §§ 3 (27) and 332 (d) of the Federal Telecommunications Act of 1996 (47 USC § 151 et seq.) and the Omnibus Budget Reconciliation Act of 1993 (Public Law 103-66, 107 USC § 312) and includes the term "wireless" and service provided by any wireless real time two-way voice communication device, including radio-telephone communications used in cellular telephone service or personal communications service (e.g., cellular telephone, 800/900 MHz Specialized Mobile Radio, Personal Communications Service, etc.).

"Commissioner" means the State Health Commissioner, the commissioner's duly authorized representative, or in the event of the commissioner's absence or a vacancy in the office of State Health Commissioner, the Acting Commissioner or Deputy Commissioner.

"Continuing education" or "CE" means an instructional program that enhances a particular area of knowledge or skills beyond compulsory or required initial training.

"Course" means a basic or advanced life support training program leading to certification or award of continuing education credit hours.

"Course coordinator" means the person identified on the course approval request as the coordinator who is responsible with the physician course director for all aspects of the program including but not limited to assuring adherence to the rules and regulations, office policies, and any contract components.

"Critical care" or "CC" in the air medical environment is a mission defined as an interfacility transport of a critically ill or injured patient whose condition warrants care commensurate with the scope of practice of a physician or registered nurse.

"Critical criteria" means an identified essential element of a state practical certification examination that must be properly performed to successfully pass the station.

"Defibrillation" means the discharge of an electrical current through a patient's heart for the purpose of restoring a perfusing cardiac rhythm. For the purpose of these regulations, defibrillation includes cardioversion.

"Defibrillator -- automated external" or "AED" means an automatic or semi-automatic device, or both, capable of rhythm analysis and defibrillation after electronically detecting the presence of ventricular fibrillation and ventricular tachycardia, approved by the U.S. Food and Drug Administration.

"Defibrillator -- manual" means a monitor/defibrillator that has no capability for rhythm analysis and will charge and deliver a shock only at the command of the operator. For the purpose of compliance with these regulations, a manual defibrillator must be capable of synchronized cardioversion and noninvasive external pacing. A manual defibrillator must be approved by the U.S. Food and Drug Administration.

"Designated emergency response agency" means an EMS agency recognized by an ordinance or a resolution of the governing body of any county, city or town as an integral part of the official public safety program of the county, city or town with a responsibility for providing emergency medical response.

"Designated infection control officer" means a liaison between the medical facility treating the source patient and the exposed employee. This person has been formally trained for this position and is knowledgeable in proper post exposure medical follow up procedures and current regulations and laws governing disease transmission.

"Director" means the Director of the Office of Emergency Medical Services.

"Diversion" means a change in the normal or established pattern of patient transport at the direction of a medical care facility.

"Emergency medical services" or "EMS" means health care, public health, and public safety services used in the medical response to the real or perceived need for immediate medical assessment, care, or transportation and preventive care or transportation in order to prevent loss of life or aggravation of physiological or psychological illness or injury.

"EMS Advisory Board" means the Emergency Medical Services Advisory Board as appointed by the Governor.

"EMS agency status report" means a report submitted on forms specified by the Office of EMS that documents the operational capabilities of an EMS agency including data on personnel, vehicles and other related resources.

"EMS education coordinator" means any EMS provider, registered nurse, physician assistant, doctor of osteopathic medicine, or doctor of medicine who possesses Virginia certification as an EMS education coordinator. Such certification does not confer authorization to practice EMS.

"Emergency medical services agency" or "EMS agency" means any person engaged in the business, service, or regular activity, whether or not for profit, of transporting or rendering immediate medical care and providing transportation to persons who are sick, injured, or otherwise incapacitated or helpless and that holds a valid license as an emergency medical services agency issued by the commissioner in accordance with § 32.1-111.6 of the Code of Virginia.

"Emergency medical services personnel" or "EMS personnel" means individuals who are employed by or affiliated members of an emergency medical services agency and who provide emergency medical services pursuant to an emergency medical services agency license issued to that agency by the commissioner and in accordance with the authorization of that agency's operational medical director.

"Emergency medical services physician" or "EMS physician" means a physician who holds current endorsement from the Office of EMS and may serve as an EMS agency operational medical director or training program physician course director.

"Emergency medical services provider" or "EMS provider" means any person who holds a valid certificate as an emergency medical services provider issued by the commissioner.

"Emergency medical services system" or "EMS system" means the system of emergency medical services agencies, vehicles, equipment, and personnel; health care facilities; other health care and emergency services providers; and other components engaged in the planning, coordination, and delivery of emergency medical services in the Commonwealth, including individuals and facilities providing communications and other services necessary to facilitate the delivery of emergency medical services in the Commonwealth.

"Emergency medical services vehicle" or "EMS vehicle" means any vehicle, vessel, aircraft, or ambulance that holds a valid emergency medical services vehicle permit issued by the Office of EMS that is equipped, maintained or operated to provide emergency medical care or transportation of patients who are sick, injured, wounded, or otherwise incapacitated or helpless.

"Emergency medical services vehicle permit" means an authorization issued by the Office of EMS for any vehicle, vessel or aircraft meeting the standards and criteria established by regulation for emergency medical services vehicles.

"Emergency medical technician instructor" means an EMS provider who holds a valid certification issued by the Office of EMS to announce and coordinate BLS programs.

"Emergency vehicle operator's course" or "EVOC" means an approved course of instruction for EMS vehicle operators that includes safe driving skills, knowledge of the state motor vehicle code affecting emergency vehicles, and driving skills necessary for operation of emergency vehicles during response to an incident or transport of a patient to a health care facility. This course must include classroom and driving range skill instruction. An approved course of instruction includes the course objectives as identified within the U.S. Department of Transportation Emergency Vehicle Operator curriculum or as approved by the Office of EMS.

"Exam series" means a sequence of opportunities to complete a certification examination with any allowed retest.

"FAA" means the U.S. Federal Aviation Administration.

"FAR" means Federal Aviation Regulations.

"FCC" means the U.S. Federal Communications Commission.

"Financial Assistance Review Committee" or "FARC" means the committee appointed by the EMS Advisory Board to administer the Rescue Squad Assistance Fund.

"Full accreditation" means an accreditation decision awarded to an entity that demonstrates satisfactory compliance with applicable Virginia standards in all performance areas.

"Fund" means the Virginia Rescue Squad Assistance Fund.

"Institutional self study" means a document whereby training programs seeking accreditation answer questions about their program for the purpose of determining their level of preparation to conduct initial EMS training programs.

"Instructor" means the teacher for a specific class or lesson of an EMS training program.

"Instructor aide" means providers certified at or above the level of instruction.

"Interfacility transport" in the air medical environment means as a mission for whom an admitted patient or patients were transported from a hospital or care giving facility (clinic, nursing home, etc.) to a receiving facility or airport.

"Interim accreditation" means an accreditation decision that results when a previously unaccredited EMS entity has been granted approval to operate one training program, for a period not to exceed 120 days, during which its application is being considered and before a provisional or full accreditation is issued, providing the following conditions are satisfied: (i) a complete application for accreditation is received by the Office of EMS and (ii) a complete institutional self study is submitted to the Office of EMS. Students attending a program with interim accreditation will not be eligible to sit for state testing until the entity achieves official notification of accreditation at the provisional or full level.

"Invasive procedure" means a medical procedure that involves entry into the living body, as by incision or by insertion of an instrument.

"License" means an authorization issued by the Office of EMS to provide emergency medical services in the state as an EMS agency.

"Local EMS resource" means a person recognized by the Office of EMS to perform specified functions for a designated geographic area. This person may be designated to perform one or more of the functions otherwise provided by regional EMS councils.

"Local EMS response plan" means a written document that details the primary service area and responding interval standards as approved by the local government and the operational medical director.

"Local governing body" or "governing body" means members of the governing body of a city, county, or town in the Commonwealth who are elected to that position or their designee.

"Major medical emergency" means an emergency that cannot be managed through the use of locally available emergency medical resources and that requires implementation of special procedures to ensure the best outcome for the greatest number of patients as determined by the EMS provider in charge or incident commander on the scene. This event includes local emergencies declared by the locality's government and states of emergency declared by the Governor.

"Medical care facility" means, as defined by § 32.1-102.1 of the Code of Virginia, any institution, place, building or agency, whether licensed or required to be licensed by the board or the Department of Behavioral Health and Developmental Services, whether operated for profit or nonprofit and whether privately owned or privately operated or owned or operated by a local governmental unit, by or in which health services are furnished, conducted, operated or offered for the prevention, diagnosis or treatment of human disease, pain, injury, deformity or physical condition, whether medical or surgical.

"Medical control" means the direction and advice provided through a communications device (on-line) to on-site and in-transit EMS personnel from a designated medical care facility staffed by appropriate personnel and operating under physician supervision.

"Medical direction" means the direction and supervision of EMS personnel by the Operational Medical Director of the EMS agency with which he is affiliated.

"Medical emergency" means the sudden onset of a medical condition that manifests itself by symptoms of sufficient severity, including severe pain, that the absence of immediate medical attention could reasonably be expected by a prudent layperson who possesses an average knowledge of health and medicine to result in (i) serious jeopardy to the mental or physical health of the individual, (ii) danger of serious impairment of the individual's bodily functions, (iii) serious dysfunction of any of the individual's bodily organs, or (iv) in the case of a pregnant woman, serious jeopardy to the health of the fetus.

"Medical practitioner" means a physician, dentist, podiatrist, licensed nurse practitioner, licensed physician's assistant, or other person licensed, registered or otherwise permitted to distribute, dispense, prescribe and administer, or conduct research with respect to, a controlled substance in the course of professional practice or research in this Commonwealth.

"Mutual aid agreement" means a written document specifying a formal understanding to lend aid to an EMS agency.

"Neonatal" or "neonate" means, for the purpose of interfacility transportation, any infant who is deemed a newborn within a hospital, has not been discharged since the birthing process, and is currently receiving medical care under a physician.

"Nonprofit" means without the intention of financial gain, advantage, or benefit as defined by federal tax law.

"OSHA" means the U.S. Occupational Safety and Health Administration or Virginia Occupational Safety and Health, the state agency designated to perform its functions in Virginia.

"Office of EMS" means the Office of Emergency Medical Services within the Virginia Department of Health.

"Operational medical director" or "OMD" means an EMS physician, currently licensed to practice medicine or osteopathic medicine in the Commonwealth, who is formally recognized and responsible for providing medical direction, oversight and quality improvement to an EMS agency and personnel.

"Operator" means a person qualified and designated to drive or pilot a specified class of permitted EMS vehicle.

"Patient" means a person who needs immediate medical attention or transport, or both, whose physical or mental condition is such that he is in danger of loss of life or health impairment, or who may be incapacitated or helpless as a result of physical or mental condition or a person who requires medical attention during transport from one medical care facility to another.

"Person" means, as defined in the Code of Virginia, any person, firm, partnership, association, corporation, company, or group of individuals acting together for a common purpose or organization of any kind, including any government agency other than an agency of the United States government.

"Physician" means an individual who holds a valid, unrestricted license to practice medicine or osteopathy in the Commonwealth.

"Physician assistant" means an individual who holds a valid, unrestricted license to practice as a physician assistant in the Commonwealth.

"Physician course director" or "PCD" means an EMS physician who is responsible for the clinical aspects of emergency medical care training programs, including the clinical and field actions of enrolled students.

"Prehospital patient care report" or "PPCR" means a document used to summarize the facts and events of an EMS incident and includes, but is not limited to, the type of medical emergency or nature of the call, the response time, the treatment provided and other minimum data items as prescribed by the board. "PPCR" includes any supplements, addenda, or other related attachments that document patient information or care provided.

"Prehospital scene" means, in the air medical environment, the direct response to the scene of incident or injury, such as a roadway, etc.

"Prescriber" means a practitioner who is authorized pursuant to §§ 54.1-3303 and 54.1-3408 of the Code of Virginia to issue a prescription.

"Primary retest status" means any candidate or provider who failed his primary certification attempt. Primary retest status expires 90 days after the primary test date.

"Primary service area" means the specific geographic area designated or prescribed by a locality (county, city or town) in which an EMS agency provides prehospital emergency medical care or transportation. This designated or prescribed geographic area served must include all locations for which the EMS agency is principally dispatched (i.e., first due response agency).

"Private Mobile Radio Service" or "PMRS" means the same as that term is defined in § 20.3 of the Federal Communications Commission's Rules, 47 CFR 20.3. For purposes of this definition, PMRS includes "industrial" and "public safety" radio services authorized under Part 90 of the Federal Communications Commission's Rules, 47 CFR 90.1 et seq., with the exception of certain for-profit commercial paging services and 800/900 MHz Specialized Mobile Radio Services that are interconnected to the public switched telephone network and are therefore classified as CMRS.

"Probationary status" means the Office of EMS will place an institution on publicly disclosed probation when it has not completed a timely, thorough, and credible root cause analysis and action plan of any sentinel event occurring there. When the entity completes an acceptable root cause analysis and develops an acceptable action plan, the Office of EMS will remove the probation designation from the entity's accreditation status.

"Provisional accreditation" means an accreditation decision that results when a previously unaccredited entity has demonstrated satisfactory compliance with a subset of standards during a preliminary on-site evaluation. This decision remains in effect for a period not to exceed 365 days, until one of the other official accreditation decision categories is assigned based upon an a follow-up site visit against all applicable standards.

"Public safety answering point" or "PSAP" means a facility equipped and staffed on a 24-hour basis to receive requests for emergency medical assistance for one or more EMS agencies.

"Quality management program" or "QM" means the continuous study of and improvement of an EMS agency or system including the collection of data, the identification of deficiencies through continuous evaluation, the education of personnel and the establishment of goals, policies and programs that improve patient outcomes in EMS systems.

"Reaccreditation date" means the date of the reaccreditation decision that is awarded to an entity following a full site visit and review.

"Recertification" means the process used by certified EMS personnel to maintain their training certifications.

"Reentry" means the process by which EMS personnel may regain a training certification that has lapsed within the last two years.

"Reentry status" means any candidate or provider whose certification has lapsed within the last two years.

"Regional EMS council" means an organization designated by the board that is authorized to receive and disburse public funds in compliance with established performance standards and whose function is to plan, develop, maintain, expand and improve an efficient and effective regional emergency medical services system within a designated geographical area pursuant to § 32.1-111.4:2 of the Code of Virginia.

"Regional trauma triage plan" means a formal written plan developed by a regional EMS council or local EMS resource and approved by the commissioner that incorporates the region's geographic variations, trauma care capabilities and resources for the triage of trauma patients pursuant to § 32.1-111.3 of the Code of Virginia.

"Registered nurse" means a person who is licensed or holds a multistate privilege under the provisions of Chapter 30 (§ 54.1-3000 et seq.) of Title 54.1 of the Code of Virginia to practice professional nursing.

"Regulated medical device" means equipment or other items that may only be purchased or possessed upon the approval of a physician and that the manufacture or sale of which is regulated by the U.S. Food and Drug Administration.

"Regulated waste" means liquid or semi-liquid blood or other potentially infectious materials; contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed; items that are caked with dried blood or potentially infectious materials and are capable of releasing these materials during handling; items dripping with liquid product; contaminated sharps; pathological and microbiological waste containing blood or other potentially infectious materials.

"Regulations" means, as defined in the Code of Virginia, any statement of general application, having the force of law, affecting the rights or conduct of any person, promulgated by an authorized board or agency.

"Rescue" means a service that may include the search for lost persons, gaining access to persons trapped, extrication of persons from potentially dangerous situations and the rendering of other assistance to such persons.

"Rescue vehicle" means a vehicle, vessel or aircraft that is maintained and operated to assist with the location and removal of victims from a hazardous or life-threatening situation to areas of safety or treatment.

"Responding time" means the elapsed time in minutes between the time a call for emergency medical services is received by the PSAP until the appropriate emergency medical response unit arrives on the scene.

"Responding time standard" means a time standard in minutes, established by the EMS agency, the locality and OMD, in which the EMS agency will comply with 90% or greater reliability.

"Response obligation to locality" means a requirement of a designated emergency response agency to lend aid to all other designated emergency response agencies within the locality or localities in which the EMS agency is based.

"Revocation" means the permanent removal of an EMS agency license, vehicle permit, training certification, ALS coordinator endorsement, EMS education coordinator, EMS physician endorsement or any other designation issued by the Office of EMS.

"Safety apparel" means personal protective safety clothing that is intended to provide conspicuity during both daytime and nighttime usage and that meets the Performance Class 2 or 3 requirements of the ANSI/ISEA 107–2010 publication entitled "American National Standard for High-Visibility Safety Apparel and Headwear."

"Secondary certification status" means any candidate or provider who is no longer in primary retest status.

"Secondary retest status" means any candidate or provider who failed their secondary certification attempt. Secondary retest status expires 90 days after the secondary test date.

"Sentinel event" means any significant occurrence, action, or change in the operational status of the entity from the time when it either applied for candidate status or was accredited. The change in status can be based on but not limited to one or all of the events indicated below:

Entering into an agreement of sale of an accredited entity or an accreditation candidate.

Entering into an agreement to purchase or otherwise directly or indirectly acquire an accredited entity or accreditation candidate.

Financial impairment of an accredited entity or candidate for accreditation, which affects its operational performance or entity control.

Insolvency or bankruptcy filing.

Change in ownership or control greater than 25%.

Disruption of service to student body.

Discontinuance of classes or business operations.

Failure to report a change in program personnel, location, change in training level or Committee on Accreditation of Educational Programs for the Emergency Medical Services Professions (CoAEMSP) accreditation status.

Failure to meet minimum examination scores as established by the Office of EMS.

Loss of CoAEMSP or Commission on Accreditation of Allied Health Education Programs (CAAHEP) accreditation.

Company fine or fines of greater than $100,000 for regulatory violation, marketing or advertising practices, antitrust, or tax disputes.

"Special conditions" means a notation placed upon an EMS agency or registration, variance or exemption documents that modifies or restricts specific requirements of these regulations.

"Specialized air medical training" means a course of instruction and continuing education in the concept of flight physiology and the effects of flight on patients that has been approved by the Office of EMS. This training must include but is not limited to aerodynamics, weather, communications, safety around aircraft/ambulances, scene safety, landing zone operations, flight physiology, equipment/aircraft familiarization, basic flight navigation, flight documentation, and survival training specific to service area.

"Specialty care mission" in the air medical environment means the transport of a patient requiring specialty patient care by one or more medical professionals who are added to the regularly scheduled medical transport team.

"Specialty care provider" in the air medical environment means a provider of specialized medical care, to include but not limited to neonatal, pediatric, and perinatal.

"Standard of care" means the established approach to the provision of basic and advanced medical care that is considered appropriate, prudent and in the best interests of patients within a geographic area as derived by consensus among the physicians responsible for the delivery and oversight of that care. The standard of care is dynamic with changes reflective of knowledge gained by research and practice.

"Standard operating procedure" or "SOP" means preestablished written agency authorized procedures and guidelines for activities performed by affiliated EMS agency.

"Supplemented transport" means an interfacility transport for which the sending physician has determined that the medically necessary care and equipment needs of a critically injured or ill patient is beyond the scope of practice of the available EMS personnel of the EMS agency.

"Suspension" means the temporary removal of an EMS agency license, vehicle permit, training certification, ALS coordinator endorsement, EMS education coordinator, EMS physician endorsement or any other designation issued by the Office of EMS.

"Test site coordinator" means an individual designated by the Office of EMS to coordinate the logistics of a state certification examination site.

"Training officer" means an individual who is responsible for the maintenance and completion of agency personnel training records and who acts as a liaison between the agency, the operational medical director, and a participant in the agency and regional quality assurance process.

"Trauma center" means a specialized hospital facility distinguished by the immediate availability of specialized surgeons, physician specialists, anesthesiologists, nurses, and resuscitation and life support equipment on a 24-hour basis to care for severely injured patients or those at risk for severe injury. In Virginia, trauma centers are designated by the Virginia Department of Health as Level I, II or III.

"Trauma center designation" means the formal recognition by the board of a hospital as a provider of specialized services to meet the needs of the severely injured patient. This usually involves a contractual relationship based on adherence to standards.

"Triage" means the process of sorting patients to establish treatment and transportation priorities according to severity of injury and medical need.

"USDOT" means the U.S. Department of Transportation.

"Vehicle operating weight" means the combined weight of the vehicle, vessel or craft; a full complement of fuel; and all required and optional equipment and supplies.

"Virginia Statewide Trauma Registry" or "Trauma Registry" means a collection of data on patients who receive hospital care for certain types of injuries. The collection and analysis of such data is primarily intended to evaluate the quality of trauma care and outcomes in individual institutions and trauma systems. The secondary purpose is to provide useful information for the surveillance of injury morbidity and mortality.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 23, Issue 6, eff. December 13, 2006; Volume 29, Issue 1, eff. October 10, 2012; Volume 32, Issue 2, eff. October 22, 2015; Volume 35, Issue 2, eff. November 2, 2018.

Article 2 Purpose and Applicability

12VAC5-31-20 Responsibility for regulations; application of regulations

Article 2 Purpose and Applicability

A. These regulations shall be administered by the following:

1. State Board of Health. The Board of Health has the responsibility to promulgate, amend, and repeal, as appropriate, regulations for the provision of emergency medical services per Article 2.1 (§ 32.1-111.1 et seq.) of Chapter 4 of Title 32.1 of the Code of Virginia.

2. State Health Commissioner. The commissioner, as executive officer of the board, will administer these regulations per § 32.1-16 of the Code of Virginia.

3. The Virginia Office of EMS. The director, assistant director and specified staff positions will have designee privileges for the purpose of enforcing these regulations.

4. Emergency Medical Services Advisory Board. The EMS Advisory Board has the responsibility to review and advise the board regarding EMS policies and programs.

B. These regulations have general application throughout Virginia to include:

1. No person may establish, operate, maintain, advertise or represent themselves, any service or any organization as an EMS agency or as EMS personnel without a valid license or certification, or in violation of the terms of a valid license or certification issued by the Office of EMS.

2. A person providing EMS to a patient received within Virginia whether treated and released or transported to a location within Virginia must comply with these regulations unless exempted in these regulations.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-30 Powers and procedures of regulations not exclusive

The board reserves the right to authorize any procedure for the enforcement of these regulations that is not inconsistent with the provisions set forth herein or the provisions of Article 2.1 (§ 32.1-111.1 et seq.) of Chapter 4 of Title 32.1 of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

Article 3 Exceptions, Variances, and Exemptions

12VAC5-31-40 Exceptions

Article 3 Exceptions, Variances, and Exemptions

Exceptions to any provision of these regulations are specified as part of the regulation concerned. Any deviation not specified in these regulations is not allowed except by variance or exemption.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-50 Variances

A. The commissioner is authorized to grant variances for any part or all of these regulations in accordance with the procedures set forth herein. A variance permits temporary specified exceptions to these regulations. An applicant, licensee, or permit or certificate holder may file a written request for a variance with the Office of EMS on specified forms. If the applicant, licensee, or permit or certificate holder is an EMS agency, the following additional requirements apply:

1. The written variance request shall be submitted for review and recommendations to the governing body or chief administrative officer of the jurisdiction in which the principal office of the EMS agency is located prior to submission to the Office of EMS.

2. An EMS agency operating in multiple jurisdictions will be required to notify all other jurisdictions in writing of conditions of approved variance requests.

3. Issuance of a variance does not obligate other jurisdictions to allow the conditions of such variance if they conflict with local ordinances or regulations.

4. Both the written request and the recommendation of the governing body or chief administrative officer shall be submitted together to the Office of EMS.

B. If the applicant for a variance is an affiliated provider who is certified or a candidate for certification, the following requirements shall apply:

1. The written variance request shall be submitted for review and recommendations to the operational medical director and the head of the agency with which the provider is affiliated.

2. Both the written request and the recommendation of the operational medical director and the agency head shall be submitted to the Office of EMS.

C. Those providers who are not affiliated with an EMS agency shall submit their variance request to the commissioner for consideration. The commissioner may request additional case-specific endorsements or supporting documentation as part of the application.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 23, Issue 6, eff. December 13, 2006; Volume 28, Issue 2, eff. November 1, 2011; Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-60 Issuance of a variance

A request for a variance may be approved and issued by the commissioner provided all of the following conditions are met:

1. The information contained in the request is complete and correct;

2. The agency, service, vehicle or person concerned is licensed, permitted or certified by the Office of EMS;

3. The commissioner determines the need for such a variance is genuine, and extenuating circumstances exist;

4. The commissioner determines that issuance of such a variance would be in the public interest and would not present any risk to, or threaten or endanger the public health, safety or welfare;

5. If the request is made by an EMS agency, the commissioner will consider the recommendation of the governing body or chief administrative officer provided all of the above conditions are met;

6. If the request is made by an affiliated provider who is certified or a candidate for certification, the Office of EMS will consider the recommendation of the operational medical director and the agency head for which the provider is affiliated; and

7. The person making the request will be notified in writing of the approval and issuance within 30 days of receipt of the request unless the request is awaiting approval or disapproval of a license or certificate. In such case, notice will be given within 30 days of the issuance of the license or certificate.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 23, Issue 6, eff. December 13, 2006; Volume 28, Issue 2, eff. November 1, 2011; Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-70 Content of variance

A variance shall include but not be limited to the following information:

1. The name of the agency, service or vehicle to which, or the person to whom, the variance applies;

2. The expiration date of the variance;

3. The provision of the regulations that is to be varied and the type of variations authorized; and

4. Any special conditions that may apply.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-80 Conditions of variance

A variance shall be issued and remain valid with the following conditions:

1. A variance will be valid for a period not to exceed one year unless and until terminated by the commissioner; and

2. A variance is neither transferable nor renewable under any circumstances.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-90 Termination of variance

A. The commissioner may terminate a variance at any time based upon any of the following:

1. Violations of any of the conditions of the variance;

2. Falsification of any information;

3. Suspension or revocation of the license, permit or certificate affected; or

4. A determination by the Office of EMS to the commissioner that continuation of the variance would present a risk to or threaten or endanger the public health, safety or welfare.

B. The commissioner will notify the license, permit or certificate holder of the termination by certified mail to his last known address.

C. Termination of a variance will take effect immediately upon receipt of notification unless otherwise specified.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-100 Denial of a variance

A request for a variance will be denied by the commissioner if any of the conditions of 12VAC5-31-60 fail to be met.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-110 Exemptions

A. The board is authorized to grant exemptions from any part or all of these regulations in accordance with the procedures set forth herein. An exemption permits specified or total exceptions to these regulations for an indefinite period.

B. Request. A person may file a written request for an exemption with the Office of EMS on specified forms. If the request is made by an EMS agency, the following additional requirements apply:

1. The written request for exemption must be submitted for review and recommendation to the governing body of the jurisdiction or chief administrative officer in which the principal office of the EMS agency is located before submission to the Office of EMS.

2. The written request must be submitted to the Office of EMS a minimum of 30 days before the scheduled review by the governing body or chief administrative officer. At the time of submission, the agency or service must provide the Office of EMS with the date, time and location of the scheduled review by the governing body or chief administrative officer.

3. Issuance of an exemption does not obligate other jurisdictions to allow the conditions of such exemption if they conflict with local ordinances or regulations.

4. Both the written request and the recommendation of the governing body or chief administrative officer shall be submitted together to the Office of EMS.

C. If the applicant for an exemption is an affiliated provider who is certified or a candidate for certification, the following requirements shall apply:

1. The written exemption request shall be submitted for review and recommendations to the operational medical director and the head of the agency with which the provider is affiliated.

2. Both the written request and the recommendation of the operational medical director and the agency head shall be submitted to the Office of EMS.

D. Those providers who are not affiliated with an EMS agency shall submit their exemption request to the commissioner for consideration. The commissioner may request additional case-specific endorsements or supporting documentation as part of the application.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003; amended, Virginia Register Volume 23, Issue 6, eff. December 13, 2006; Volume 28, Issue 2, eff. November 1, 2011.

12VAC5-31-120 Public notice of request for exemption

Upon receipt of a request for an exemption, the Office of EMS will cause notice of such request to be posted on the Office of EMS section of the Virginia Department of Health's website.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-130 Public hearing for exemption request

If the board determines that there is substantial public interest in a request for an exemption, a public hearing may be held.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-140 Issuance of an exemption

A. A request for an exemption may be approved and an exemption issued provided all of the following conditions are met:

1. The information contained in the request is complete and correct.

2. The need for such an exemption is determined to be genuine.

3. The issuance of an exemption would not present any risk to, threaten or endanger the public health, safety or welfare of citizens.

B. If the request is made by an EMS agency, the board may accept the recommendation of the governing body or chief administrative officer provided all of the conditions in subsection A of this section are met.

C. If the request is made by an affiliated provider who is certified or a candidate for certification, the board will consider the recommendation of the operational medical director and the agency head with which the provider is affiliated.

D. The person making the request will be notified in writing of the approval or denial of a request.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003; amended, Virginia Register Volume 23, Issue 6, eff. December 13, 2006; Volume 28, Issue 2, eff. November 1, 2011.

12VAC5-31-150 Content of exemption

An exemption includes but is not limited to the following information:

1. The name of the agency, service or vehicle to which, or the person to whom, the exemption applies;

2. The provisions of the regulations that will be exempted; and

3. Any special conditions that may apply.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-160 Conditions of exemption

A. An exemption remains valid for an indefinite period of time unless and until terminated by the commissioner, or unless an expiration date is specified.

B. An exemption is neither transferable nor renewable.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-170 Termination of exemption

A. The commissioner may terminate an exemption at any time based upon any of the following:

1. Violation of any of the conditions of the exemption;

2. Suspension or revocation of any licenses, permits or certificates involved; or

3. A determination by the commissioner that continuation of the exemption would present risk to, or threaten or endanger the public health, safety or welfare.

B. The commissioner will notify the person to whom the exemption was issued of the termination by certified mail to his last known address.

C. Termination of an exemption takes effect immediately upon receipt of notification unless otherwise specified.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-180 Denial of an exemption

A request for an exemption will be denied by the commissioner if any of the conditions of these regulations fail to be met.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-190 General exemptions from these regulations

The following are exempted from these regulations except as noted:

1. A person or privately owned vehicle not engaged in the business, service, or regular activity of providing medical care or transportation of persons who are sick, injured, wounded, or otherwise disabled;

2. A person or vehicle assisting with the rendering of emergency medical services or medical transportation in the case of a major medical emergency as reasonably necessary when the EMS agencies, vehicles, and personnel based in or near the location of such major emergency are insufficient to render the services required;

3. An EMS agency operated by the United States government within this state. Any person holding a United States government contract is not exempt from these regulations unless the person only provides services within an area of exclusive federal jurisdiction;

4. A medical care facility, but only with respect to the provision of emergency medical services within such facility;

5. Personnel employed by or associated with a medical care facility that provides emergency medical services within that medical care facility, but only with respect to the services provided therein;

6. An EMS agency based in a state bordering Virginia when requested to respond into Virginia for the purpose of providing mutual aid in the primary service area of a designated emergency response agency with the following conditions:

a. This agency must comply with the terms of a written mutual aid agreement with the EMS agency; and

b. This agency must comply with applicable EMS regulations of its home state.

7. An EMS agency that operates in Virginia for the exclusive purpose of interstate travel.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003; amended, Virginia Register Volume 23, Issue 6, eff. December 13, 2006.

Article 4 Enforcement Procedures

12VAC5-31-200 Right to enforcement

Article 4 Enforcement Procedures

A. The Office of EMS may use the enforcement procedures provided in this article when dealing with any deficiency or violation of these regulations or any action or procedure that varies from the intent of these regulations.

B. The Office of EMS may determine that a deficiency or violation of these regulations or any action or procedure that varies from the intent of these regulations occurred.

C. The enforcement procedures provided in this article are not mutually exclusive. The Office of EMS may invoke as many procedures as the situation may require.

D. The commissioner empowers the Office of EMS to enforce the provisions of these regulations.

E. An agency and all places of operation shall be subject to inspection by the Office of EMS for compliance with these regulations. The inspection may include any or all of the following:

1. All fixed places of operations, including all offices, stations, repair shops, or training facilities.

2. All applicable records maintained by the agency.

3. All EMS vehicles and required equipment used by the agency.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-210 Enforcement actions

An enforcement action must be delivered to the affected person and must specify information concerning the violations, the actions required to correct the violations and the specific date by which correction must be made as follows:

1. Warning: a verbal notification of an action or situation potentially in violation of these regulations.

2. Citation: a written notification for violations of these regulations.

3. Suspension: a written notification of the deactivation and removal of authorization issued under a license, permit, certification, endorsement or designation.

4. Civil penalty: The commissioner or designee may impose a civil penalty on an agency or entity that fails or refuses compliance with these regulations. Civil penalties may be assessed up to $1,000 per offense. Violations shall be single, different occurrence for each calendar day the violation occurs and remains uncorrected.

5. Action of the commissioner: the commissioner may command a person operating in violation of these regulations or state law pursuant to the commissioner's authority under § 32.1-27 of the Code of Virginia and the Administrative Process Act to halt such operation or to comply with applicable law or regulation. A separate and distinct offense will be deemed to have been committed on each day during which any prohibited act continues after written notice to the offender.

6. Criminal enforcement: the commissioner may elect to enforce any part of these regulations or any provision of Title 32.1 of the Code of Virginia by seeking to have criminal sanctions imposed. The violation of any of the provisions of these regulations constitutes a misdemeanor. A separate and distinct offense will be deemed to have been committed on each day during which any prohibited act continues after written notice by the commissioner to the offender.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-220 Suspension of a license, permit, certificate, endorsement or designation

A. The commissioner may suspend an EMS license, permit, certificate, endorsement or designation without a hearing, pending an investigation or revocation procedure.

1. Reasonable cause for suspension must exist before such action is taken by the commissioner. The decision must be based upon a review of evidence available to the commissioner.

2. The commissioner may suspend an agency or service license, vehicle permit, personnel certificate, endorsement or designation for failure to adhere to the standards set forth in these regulations.

3. An EMS agency license or registration may be suspended if the agency, service or any of its vehicles or personnel are found to be operating in a manner that presents a risk to, or threatens, or endangers the public health, safety or welfare.

4. An EMS vehicle permit may be suspended if the vehicle is found to be operated or maintained in a manner that presents a risk to, threatens, or endangers the public health, safety or welfare, or if the EMS agency license has been suspended.

5. EMS personnel may be suspended if found to be operating or performing in a manner that presents a risk to, or threatens, or endangers the public health, safety or welfare.

6. An EMS training certification may be suspended if the certificate holder is found to be operating or performing in a manner that presents a risk to, or threatens, or endangers the public health, safety or welfare.

B. Suspension of an EMS agency license shall result in the simultaneous and concurrent suspension of the vehicle permits.

C. The commissioner will notify the licensee, or permit or certificate holder of the suspension in person or by certified mail to his last known address.

D. A suspension takes effect immediately upon receipt of notification unless otherwise specified. A suspension remains in effect until the commissioner further acts upon the license, permit, certificate, endorsement or designation or until the order is overturned on appeal as specified in the Administrative Process Act.

E. The licensee, or permit or certificate holder shall abide by any notice of suspension and shall return all suspended licenses, permits and certificates to the Office of EMS within 10 days of receipt of notification.

F. The Office of EMS may invoke any procedure set forth in this part to enforce the suspension.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 23, Issue 6, eff. December 13, 2006; Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-230 Revocation of a license, permit or certificate

A. The commissioner may revoke an EMS license, permit, certificate, endorsement, or designation after a hearing or waiver thereof.

1. Reasonable cause for revocation must exist before such action by the commissioner.

2. The commissioner may revoke an EMS agency license, EMS vehicle permit, vehicle permit, certification, endorsement or designation for failure to adhere to the standards set forth in these regulations.

3. The commissioner may revoke an EMS agency license, an EMS vehicle permit, or EMS personnel certificate for violation of a correction order or for engaging in or aiding, abetting, causing, or permitting any act prohibited by these regulations.

4. The commissioner may revoke an EMS training certificate for failure to adhere to the standards as set forth in these regulations or for lack of competence at such level as evidenced by lack of basic knowledge or skill, or for incompetent or unwarranted acts inconsistent with the standards in effect for the level of certification concerned.

5. The commissioner may revoke an EMS agency license for violation of federal or state laws resulting in a civil monetary penalty.

B. Revocation of an EMS agency license shall result in the simultaneous and concurrent revocation of vehicle permits.

C. The commissioner will notify the holder of a license, certification, endorsement or designation of the intent to revoke by signed receipt in person or certified mail to his last known address.

D. The holder of a license, certification, endorsement or designation will have the right to a hearing.

1. If the holder of a license, certification, endorsement or designation desires to exercise his right to a hearing, he must notify the Office of EMS in writing of his intent within 10 days of receipt of notification. In such cases, a hearing must be conducted and a decision rendered in accordance with the Administrative Process Act.

2. Should the holder of a license, certification, endorsement or designation fail to file such notice, he will be deemed to have waived the right to a hearing. In such case, the commissioner may revoke the license or certificate.

E. A revocation takes effect immediately upon receipt of notification unless otherwise specified. A revocation order is permanent unless and until overturned on appeal.

F. The holder of a license, certification, endorsement or designation shall abide by any notice of revocation and shall return all revoked licenses, permits and certificates to the Office of EMS within 10 days of receipt of the notification of revocation.

G. The Office of EMS may invoke any procedures set forth in this part to enforce the revocation.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 23, Issue 6, eff. December 13, 2006; Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-240 Correction order

A. The Office of EMS may order the holder of a license, certification, endorsement or designation to correct a deficiency, cease any violations or comply with these regulations by issuing a written correction order as follows:

1. Correction orders may be issued in conjunction with any other enforcement action in response to individual violations or patterns of violations.

2. The Office of EMS will determine that a deficiency or violation exists before issuance of any correction order.

B. The Office of EMS will send a correction order to the licensee or permit or certificate holder by a signed receipt in person or certified mail to his last known address. Notification will include, but not be limited to, a description of the deficiency or violation to be corrected, and the period within which the deficiency or situation must be corrected, which shall not be less than 30 days from receipt of such order, unless an emergency has been declared by the Office of EMS.

C. A correction order takes effect upon receipt and remains in effect until the deficiency is corrected or until the license, permit, certificate, endorsement or designation is suspended, revoked, or allowed to expire or until the order is overturned or reversed.

D. Should the licensee or permit, certificate, endorsement or designation holder be unable to comply with the correction order by the prescribed date, he may submit a request for modification of the correction order with the Office of EMS. The Office of EMS will approve or disapprove the request for modification of the correction order within 10 days of receipt.

E. The licensee or permit, certificate, endorsement or designation holder shall correct the deficiency or situation within the period stated in the order.

1. The Office of EMS will determine whether the correction is made by the prescribed date.

2. Should the licensee or permit, certificate, endorsement or designation holder fail to make the correction within the time period cited in the order, the Office of EMS may invoke any of the other enforcement procedures set forth in this part.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-250 Judicial review

A. The procedures of the Administrative Process Act controls all judicial reviews.

B. A licensee; permit, certificate, endorsement or designation holder; or applicant has the right to appeal any decision or order of the Office of EMS except as may otherwise be prohibited, and provided such a decision or order was not the final decision of an appeal.

C. The licensee; permit, certificate, endorsement or designation holder; or applicant shall abide by any decision or order of the Office of EMS, or he must cease and desist pending any appeal.

D. If the person who sought the appeal is aggrieved by the final decision, that person may seek judicial review as provided in the Administrative Process Act.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

Article 5 Complaints

12VAC5-31-260 Submission of complaints

Article 5 Complaints

Any person may submit a complaint. A complaint is submitted in writing to the Office of EMS, signed by the complainant and includes the following information:

1. The name and address of the complainant;

2. The name of the agency, service or person involved;

3. A description of any vehicle involved; and

4. A detailed description of the complaint, including the date, location and conditions and the practice or act that exists or has occurred.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-270 Investigation process

A. The Office of EMS may investigate complaints received about conditions, practices, or acts that may violate any provision of either Article 2.1 of Chapter 4 (§ 32.1-111.1 et seq.) of Title 32.1 of the Code of Virginia or provision of these regulations.

B. If the Office of EMS determines that the conditions, practices, or acts cited by the complainant are not in violation of applicable sections of the Code of Virginia or these regulations, then the Office of EMS will investigate no further.

C. If the Office of EMS determines that the conditions, practices, or acts cited by the complainant may be in violation of applicable sections of the Code of Virginia or these regulations, then the Office of EMS will investigate the complaint fully in order to determine if a violation took place.

D. The Office of EMS may investigate or continue to investigate and may take appropriate action on a complaint even if the original complainant withdraws his complaint or otherwise indicates a desire not to cause it to be investigated to completion.

E. The Office of EMS may initiate a formal investigation or action based on an anonymous or unwritten complaint.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-280 Action by the Office of EMS

A. If the Office of EMS determines that a violation has occurred, it may apply all provisions of these regulations that it deems necessary and appropriate.

B. At the completion of an investigation and following any appeals, the Office of EMS will notify the complainant.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-290 Exclusions from these regulations

A. Any person or privately owned vehicle not engaged in the business, service, or regular activity of providing medical care or transportation of persons who are sick, injured, wounded, or otherwise disabled.

B. Any person or vehicle rendering emergency medical services or medical transportation in the case of a major medical emergency when the EMS agencies, vehicles and personnel based in or near the location of such major emergency are insufficient to render services required.

C. EMS agencies, vehicles or personnel based outside of Virginia, except that any agency, vehicle or person responding from outside Virginia to an emergency within Virginia and providing emergency medical services to a patient within Virginia, whether or not the service includes transportation, shall comply with the provisions of these regulations.

D. An agency of the United States government providing emergency medical services in Virginia and any EMS vehicles operated by the agency.

E. Any vehicle owned by an EMS agency used exclusively for the provision of rescue services.

F. Any medical facility, but only with respect to the provision of emergency medical services within the facility.

G. Personnel employed by, or associated with, a medical facility who provides emergency medical services within the medical facility, but only with respect to the services provided therein.

H. Wheelchair interfacility transport services and wheelchair interfacility transport service vehicles that are engaged, whether or not for profit, in the business, service, or regular activity of and exclusively used for transporting wheelchair bound passengers between medical facilities in the Commonwealth when no ancillary medical care or oversight is necessary. However, such services and vehicles shall comply with Department of Medical Assistance Services regulations regarding the transportation of Medicaid recipients to covered services.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 1, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

Article 1 EMS Agency Licensure and Requirements

12VAC5-31-300 Requirement for EMS agency licensure and EMS certification

Article 1 EMS Agency Licensure and Requirements

No person may establish, operate, maintain, advertise or represent themselves or any service or organization as an EMS agency or as EMS personnel without a valid license or certification, or in violation of the terms of a valid license or certification, issued by the Office of EMS.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-310 Provision of EMS within Virginia

A person providing EMS to a patient received within Virginia and transported to a location within Virginia shall comply with these regulations.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-320 General applicability of the regulations

These regulations have general application throughout Virginia for an EMS agency and an applicant for EMS agency licensure.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-330 Compliance with regulations

A. A person shall comply with these regulations.

B. An EMS agency, including its EMS vehicles and EMS personnel, shall comply with these regulations, the applicable regulations of other state agencies, the Code of Virginia, and the United States Code.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-340 EMS agency name

A person may not apply to conduct business under a name that is the same as or misleadingly similar to the name of a person licensed or registered by the Office of EMS.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-350 Ability to pay

In the case of an emergency illness or injury, an EMS agency may not refuse to provide required services including dispatch, response, rescue, life support, emergency transport and interfacility transport based on the inability of the patient to provide means of payment for services rendered by the agency. An EMS agency's decision to refer or refuse to provide service must be based upon the "prudent layperson" standard for determination of the existence of a medical emergency as defined under "emergency services" in § 38.2-4300 of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-360 Public access

An EMS agency shall provide for a publicly listed telephone number to receive calls for service from the public.

1. The number must be answered in person on a 24-hour basis.

2. Exception: An EMS agency that does not respond to calls from the public but responds only to calls from a unique population shall provide for a telephone number known to the unique population it serves. The number must be answered during all periods when that population may require service and at all other times must direct callers to the nearest available EMS agency.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-370 Designated emergency response agency

An EMS agency that responds to medical emergencies for its primary service area shall be a designated emergency response agency. A designated emergency response agency shall provide services within its primary service area as defined by the local EMS response plan.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-380 EMS agency availability

A. An EMS agency shall provide service within its primary service area as defined by the local EMS response plan.

B. Licensed EMS agencies that meet the criteria stated in 12VAC5-31-370 but that operate under special conditions, i.e., time of year, etc., must also meet the criteria outlined in 12VAC5-31-430 A 2 and C 4.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-390 Destination to specialty care hospitals

An EMS agency shall follow specialty care hospital triage plans established in accordance with § 32.1-111.3 of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-400 Nondiscrimination

An EMS agency shall not discriminate due to a patient's race, gender, creed, color, national origin, location, medical condition or any other reason.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-410 EMS agency licensure classifications

An EMS agency license may be issued for any combination of the following classifications of EMS services:

1. Nontransport first response.

a. Basic life support.

b. Advanced life support.

2. Ground ambulance.

a. Basic life support.

b. Advanced life support.

3. Neonatal ambulance.

4. Air ambulance.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-420 Application for EMS agency license

A. An applicant for EMS agency licensure shall file a written application specified by the Office of EMS.

B. The Office of EMS may use whatever means of investigation necessary to verify any or all information contained in the application.

C. An ordinance or resolution from the governing body of each locality where the agency maintains an office, stations an EMS vehicle for response within a locality or is a Designated Emergency Response Agency as required by § 15.2-955 of the Code of Virginia confirming approval. This ordinance or resolution must specify the geographic boundaries of the agency's primary service area within the locality.

D. The Office of EMS will determine whether an applicant or licensee is qualified for licensure based upon the following:

1. An applicant or licensee must meet the personnel requirements of these regulations.

2. If the applicant is a company or corporation, as defined in § 12.1-1 of the Code of Virginia, it must clearly disclose the identity of its owners, officers and directors.

3. An applicant or licensee must provide information on any previous record of performance in the provision of emergency medical service or any other related licensure, registration, certification or endorsement within or outside Virginia.

4. The applicant must submit a written agreement with the local governing body that states the applicant agency will assist in mutual aid requests from the local government if EMS personnel, vehicles, equipment, and other resources are available.

E. An applicant agency and all places of operation shall be subject to inspection by the Office of EMS for compliance with these regulations. The inspection may include any or all of the following:

1. All fixed places of operations, including all offices, stations, repair shops or training facilities.

2. All applicable records maintained by the applicant agency.

3. All EMS vehicles and required equipment used by the applicant agency.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-430 Issuance of an EMS agency license

A. An EMS agency license may be issued by the Office of EMS provided the following conditions are met:

1. All information contained in the application is complete and correct; and

2. The applicant is determined by the Office of EMS to be eligible for licensure in accordance with these regulations.

3. The applicant is determined by the Office of EMS to provide emergency medical services to the citizens of the Commonwealth in accordance with this chapter.

B. The issuance of a license hereunder may not be construed to authorize any agency to operate any emergency medical services vehicle without a franchise or permit in any county or municipality which has enacted an ordinance pursuant to § 32.1-111.14 of the Code of Virginia making it unlawful to do so.

C. An EMS agency license may include the following information:

1. The name and address of the EMS agency;

2. The expiration date of the license;

3. The types of services for which the EMS agency is licensed; and

4. Any special conditions that may apply.

D. An EMS agency license will be issued and remain valid with the following conditions:

1. An EMS agency license is valid for a period of no longer than two years from the last day of the month of issuance unless and until revoked or suspended by the commissioner.

2. An EMS agency license is not transferable.

3. An EMS agency license issued by the Office of EMS remains the property of the Office of EMS and may not be altered or destroyed.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-440 Display of EMS agency license

An EMS agency license is publicly displayed in the headquarters of the EMS agency and a copy displayed in each place of operations.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-450 EMS agency licensure renewal

A. An EMS agency license renewal may be granted following an inspection as set forth in these regulations based on the following conditions:

1. The renewal inspection results demonstrate that the EMS agency complies with these regulations.

2. There have been no documented violations of these regulations that preclude a renewal.

B. If the Office of EMS is unable to take action on a renewal application of a license before expiration, the license remains in full force and effect until the Office of EMS completes processing of a renewal application.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-460 Denial of an EMS agency license

A. An application for a new EMS agency license or renewal of an EMS agency license may be denied by the Office of EMS if the applicant or agency does not comply with these regulations.

B. An application for a new agency license or renewal of an EMS agency license shall not be issued by the Office of EMS to any firm, corporation, agency, organization, or association that does not intend to provide emergency medical services as part of its operation to the citizens of the Commonwealth.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-470 Modification of an EMS agency license

A. Any change in the classifications of the EMS vehicles or medical equipment packages permitted to an EMS agency or in any of the conditions that may apply to the EMS agency requires the notification of the Office of EMS and the modification of the EMS agency license.

B. The procedure for modification of a license is as follows:

1. The licensee shall request the modifications in writing on a form prescribed by the Office of EMS.

2. The Office of EMS may use the full provisions of these regulations in processing a request as an application.

3. Upon receiving a modified license, an EMS agency shall return the original license to the Office of EMS within 15 days and destroy all copies.

4. The issuance of a modified license hereunder may not be construed to authorize an EMS agency to provide emergency medical services or to operate an EMS vehicle without a franchise in any county or municipality that has enacted an ordinance requiring it.

C. A request for modification of an EMS agency license may be denied by the Office of EMS if the applicant or agency does not comply with these regulations.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-480 Termination of EMS agency licensure

A. An EMS agency terminating service shall surrender the EMS agency license to the Office of EMS.

B. An EMS agency terminating service shall submit written notice to the Office of EMS at least 90 days in advance. Written notice of intent to terminate service must verify the following:

1. Notification of the applicable OMDs, regional EMS councils or local EMS resource agencies, PSAPs and governing bodies of each locality served.

2. Termination of all existing contracts for EMS services, Mutual Aid Agreements, or both.

3. Advertised notice of its intent to discontinue service has been published in a newspaper of general circulation in its service area and to be posted on the Office of EMS section of the Virginia Department of Health's website.

C. Within 30 days following the termination of service, the EMS agency shall provide written verification to the Office of EMS of the following:

1. The return of its EMS agency license and all associated vehicle permits to the Office of EMS.

2. The removal of all signage or insignia that advertise the availability of EMS to include but not be limited to facility and roadway signs, vehicle markings and uniform items.

3. The return of all drug kits that are part of a local or regional drug kit exchange program or provision for the proper disposition of drugs maintained under a Board of Pharmacy controlled substance registration.

4. The maintenance and secure storage of required agency records and prehospital patient care reports for a minimum of six years from the date of termination of service.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-490 EMS agency insurance

A. An EMS agency shall have in effect and be able to furnish proof on demand of contracts for vehicular insurance as follows:

1. Insurance coverage for emergency vehicles shall meet or exceed the minimum requirements as set forth in § 46.2-920 of the Code of Virginia.

2. Insurance coverage for nonemergency vehicles shall meet or exceed the minimum requirements as set forth in § 46.2-472 of the Code of Virginia.

3. Insurance coverage for both classes of aircraft shall meet or exceed the minimum requirements as set forth in § 5.1-88.2 of the Code of Virginia.

B. Nothing in this section prohibits an authorized governmental agency from participating in an authorized "self-insurance" program as long as the program provides for the minimum coverage levels specified in this section.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-500 Place of operations

A. An EMS agency shall maintain a fixed physical location. Any change in the address of the primary business location and any satellite location require notification to the Office of EMS before relocation of the office space.

B. Adequate, clean and enclosed storage space for linens, equipment and supplies shall be provided at each place of operation.

C. The following sanitation measures are required at each place of operation established by the CDC and the Virginia occupational safety and health laws (Title 40.1 of the Code of Virginia):

1. All areas used for storage of equipment and supplies shall be kept neat, clean, and sanitary.

2. All soiled supplies and used disposable items shall be stored or disposed of in plastic bags, covered containers or compartments provided for this purpose. Regulated waste shall be stored in a red or orange bag or container clearly marked with a biohazard label.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-510 Equipment and supplies

A. An EMS agency shall hold the permit to an EMS vehicle or have a written agreement for the access to and use of an EMS vehicle. An EMS agency that does not use an EMS vehicle shall maintain the required equipment and supplies for a nontransport response vehicle.

B. Adequate stocks of supplies and linens shall be maintained as required for the classes of vehicles in service at each place of operations. An EMS agency shall maintain a supply of at least 25 triage tags of a design approved by the Office of EMS on each permitted EMS vehicle.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-520 Storage and security of drugs and related supplies

A. An area used for storage of drugs and administration devices and a drug kit used on an EMS vehicle shall comply with requirements established by the Virginia Board of Pharmacy and the applicable drug manufacturer's recommendations for climate-controlled storage.

B. Drugs and drug kits shall be maintained within their expiration date at all times.

C. Drugs and drug kits shall be removed from vehicles and stored in a properly maintained and locked secure area when the vehicle is not in use unless the ambient temperature of the vehicle's interior drug storage compartment is maintained within the climate requirements specified in this section.

D. An EMS agency shall notify the Office of EMS in writing of any diversion of (i.e., loss or theft) or tampering with any controlled substances, drug delivery devices, or other regulated medical devices from an agency facility or vehicle. Notification shall be made within 15 days of the discovery of the occurrence.

E. An EMS agency shall protect EMS vehicle contents from climate extremes.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-530 Preparation and maintenance of records and reports

An EMS agency is responsible for the preparation and maintenance of records that shall be available for inspection by the Office of EMS as follows:

1. Records and reports shall at all times be stored in a manner to ensure reasonable safety from water and fire damage and from unauthorized disclosure to persons other than those authorized by law.

2. EMS agency records shall be prepared and securely maintained at the principal place of operations or a secured storage facility for a period of not less than five years.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-540 Personnel records

A. An EMS agency shall have a current personnel record for each individual affiliated with the EMS agency. Each file shall contain documentation of certification, training and qualifications for the positions held.

B. An EMS agency shall have a record for each individual affiliated with the EMS agency documenting the results of a criminal history background check conducted through the Central Criminal Records Exchange and the National Crime Information Center via the Virginia State Police, a driving record transcript from the individual's state Department of Motor Vehicles office, and any documents required by the Code of Virginia, no more than 60 days prior to the individual's affiliation with the EMS agency.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-550 EMS vehicle records

An EMS agency shall have records for each vehicle currently in use to include maintenance reports demonstrating adherence to manufacturer's recommendations for preventive maintenance, valid vehicle registration, safety inspection, vehicle insurance coverage and any reportable motor vehicle collision as defined by the Motor Vehicle Code (Title 46.2 of the Code of Virginia).

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-560 Patient care records

A. An original PPCR shall specifically identify by name the personnel who meet the staffing requirements of the EMS vehicle.

B. The PPCR shall include the name and identification number of all EMS Personnel on the EMS vehicle and the signature of the attendant-in-charge.

C. The required minimum data set shall be submitted on a schedule established by the Office of EMS as authorized in § 32.1-116.1 of the Code of Virginia. This requirement for data collection and submission shall not apply to patient care rendered during local emergencies declared by the locality's government and states of emergency declared by the Governor. During such an incident, an approved triage tag shall be used to document patient care provided unless a standard patient care report is completed.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-570 EMS agency status report

A. An EMS agency must submit an "EMS Agency Status Report" to the Office of EMS within 30 days of a request or change in status of the following:

1. Chief executive officer.

2. Training officer.

3. Designated infection control officer.

B. The EMS agency shall provide the leadership position held, to include title, term of office, mailing address, home and work telephone numbers, other available electronic addresses for each individual, and other information as required.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-580 Availability of these regulations

An EMS agency shall have readily available at each station a current copy of these regulations for reference use by its officers and personnel.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-590 Operational Medical Director requirement

A. An EMS agency shall have a minimum of one operational medical director (OMD) who is a licensed physician holding endorsement as an EMS physician from the Office of EMS.

An EMS agency shall enter into a written agreement with an EMS physician to serve as OMD with the EMS agency. This agreement shall at a minimum specify the following responsibilities and authority:

1. This agreement must describe the process or procedure by which the OMD or EMS agency may discontinue the agreement with prior notification of the parties involved pursuant to 12VAC5-31-1910.

2. This agreement must identify the specific responsibilities of each EMS physician if an EMS agency has multiple OMDs.

3. This agreement must specify that EMS agency personnel may only provide emergency medical care and participate in associated training programs while acting with the authorization of the operational medical director and within the scope of the EMS agency license in accordance with these regulations.

4. This agreement must provide for EMS agency personnel to have access to the agency OMD in regards to discussion of issues relating to provision of patient care, application of patient care protocols or operation of EMS equipment used by the EMS agency.

5. This agreement must ensure that the adequate indemnification or insurance coverage exists for:

a. Medical malpractice; and

b. Civil claims.

B. EMS agency and OMD conflict resolution.

1. In the event of an unresolved conflict between an EMS agency and its OMD, the issues involved shall be brought before the regional EMS council or local EMS resource's medical direction committee (or approved equivalent) for review and resolution.

2. When an EMS agency determines that the OMD presents an immediate significant risk to the public safety or health of citizens, the EMS agency shall attempt to resolve the issues in question. If an immediate risk remains unresolved, the EMS agency shall contact the Office of EMS for assistance.

C. Change of operational medical director.

1. An EMS agency choosing to secure the services of another OMD shall provide a minimum of 30 days advance written notice of intent to the current OMD and the Office of EMS.

2. An OMD choosing to resign shall provide the EMS agency and the Office of EMS with a minimum of 30 days written notice of such intent.

3. When extenuating circumstances require an immediate change of an EMS agency's OMD (e.g., death, critical illness, etc.), the Office of EMS shall be notified by the OMD within one business day so that a qualified replacement may be approved. In the event that the OMD is not capable of making this notification, the EMS agency shall be responsible for compliance with this requirement. Under these extenuating circumstances, the Office of EMS will make a determination whether the EMS agency will be allowed to continue its operations pending the approval of a permanent or temporary replacement OMD.

4. When temporary circumstances require a short-term change of an EMS agency's OMD for a period not expected to exceed one year (e.g., military commitment, unexpected clinical conflict, etc.), the Office of EMS shall be notified by the OMD within 15 days so that a qualified replacement may be approved.

5. The Office of EMS may delay implementation of a change in an EMS agency's OMD pending the completion of any investigation of an unresolved conflict or possible violation of these regulations or the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-600 Quality management reporting

An EMS agency shall have an ongoing Quality Management (QM) Program designed to objectively, systematically and continuously monitor, assess and improve the quality and appropriateness of patient care provided by the agency. The QM Program shall be integrated and include activities related to patient care, communications, and all aspects of transport operations and equipment maintenance pertinent to the agency's mission. The agency shall maintain a QM report that documents quarterly PPCR reviews, supervised by the operational medical director.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-610 Designated emergency response agency standards

A. A designated emergency response agency shall develop or participate in a written local EMS response plan that addresses the following items:

1. The designated emergency response agency shall develop and maintain, in coordination with their locality, a written plan to provide 24-hour coverage of the agency's primary service area with the available personnel to achieve the approved responding interval standard.

2. A designated emergency response agency shall conform to the local responding interval, or in the absence of a local standard the EMS agency shall develop a standard in conjunction with OMD and local government in the best interests of the patient and the community. The EMS agency shall use the response time standard to establish a time frame the EMS agency complies with on a 90% basis within its primary service area (i.e., a time frame in which the EMS agency can arrive at the scene of a medical emergency in 90% or greater of all calls).

a. If the designated emergency response agency finds it is unable to respond within the established unit mobilization interval standard, the call shall be referred to the closest available mutual aid EMS agency.

b. If the designated emergency response agency finds it is able to respond to the patient location sooner than the mutual aid EMS agency, the EMS agency shall notify the PSAP of its availability to respond.

c. If the designated emergency response agency is unable to respond (e.g., lack of operational response vehicle or available personnel), the EMS agency shall notify the PSAP.

d. If a designated emergency response agency determines in advance that it will be unable to respond for emergency service for a specified period of time, it shall notify its PSAP.

B. A designated emergency response agency shall have available for review a copy of the local EMS response plan that shall include the established EMS Responding Interval standards.

C. A designated emergency response agency shall document its compliance with the established EMS response capability, unit mobilization interval, and responding interval standards.

D. A designated emergency response agency shall document an annual review of exceptions to established EMS response capability and time interval standards. The results of this review shall be provided to the agency's operational medical director and local governing body.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-630 Designated emergency response agency mutual aid

A. A designated emergency response agency shall provide aid to all other designated emergency response agencies within the locality.

B. A designated emergency response agency shall maintain written mutual aid agreements with adjacent designated emergency response agencies in another locality with which it shares a common border. Mutual aid agreements shall specify the types of assistance to be provided and any conditions or limitations for providing this assistance.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

Article 2 Emergency Medical Services Vehicle Permit

12VAC5-31-640 EMS vehicle permit requirement

Article 2 Emergency Medical Services Vehicle Permit

A. A person may not operate or maintain any motor vehicle, vessel or craft as an EMS vehicle without a valid permit or in violation of the terms of a valid permit.

B. An EMS agency shall file written application for a permit on forms specified by the Office of EMS.

C. The Office of EMS may verify any or all information contained in the application before issuance.

D. The Office of EMS shall inspect the EMS vehicle for compliance with the vehicle requirements for the class in which a permit is sought.

E. An EMS vehicle permit may be issued provided all of the following conditions are met:

1. All information contained in the application is complete and correct.

2. The applicant is an EMS agency.

3. The EMS vehicle is registered or permitted by the Department of Motor Vehicles or approved equivalent.

4. The inspection meets the minimum requirements as defined in these regulations.

5. The issuance of an EMS vehicle permit does not authorize any person to operate an EMS vehicle without a franchise or permit in any county or municipality that has enacted an ordinance requiring one.

F. An EMS vehicle permit may include but is not be limited to the following information:

1. The name and address of the agency.

2. The expiration date of the permit.

3. The classification and type of the EMS vehicle.

4. The motor vehicle license plate number of the vehicle.

5. Any special conditions that may apply.

G. An EMS vehicle permit may be issued and remain valid with the following conditions:

1. An EMS vehicle permit remains the property of the Office of EMS and may not be altered or destroyed.

2. An EMS vehicle permit is valid only as long as the EMS agency license is valid.

3. An EMS vehicle permit is not transferable.

4. An EMS agency must equip an EMS vehicle in compliance with these regulations at all times unless the vehicle is permitted as "reserved." A designated emergency response Agency may be issued a "reserved" permit by the Office of EMS.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-650 Temporary EMS vehicle permit

A. A temporary EMS vehicle permit may be issued for a permanent replacement or additional EMS vehicle pending inspection. A temporary EMS vehicle permit will not be issued for a vehicle requesting a "reserved" permit.

B. An EMS agency shall file written application for a temporary permit on forms specified by the Office of EMS. Submission of this application requires the EMS agency to attest that the vehicle complies with these regulations.

C. The Office of EMS may verify any or all information contained in the application before issuance.

D. The procedure for issuance of a temporary EMS vehicle permit is as follows:

1. An EMS agency requesting a temporary permit shall submit a completed application for an EMS vehicle permit attesting that the vehicle complies with these regulations.

2. The Office of EMS may inspect an EMS vehicle issued a temporary permit at any time for compliance with these regulations and issuance of an EMS vehicle permit.

E. A temporary EMS vehicle permit may include but not be limited to the following information:

1. The name and address of the EMS agency.

2. The expiration date of the EMS vehicle permit.

3. The classification and type of the EMS vehicle.

4. The motor vehicle license plate number of the vehicle.

5. Any special conditions that may apply.

F. A temporary EMS vehicle permit will be issued and remain valid with the following conditions:

1. A temporary EMS vehicle permit is valid for 180 days from the end of the month issued.

2. A temporary EMS vehicle permit is not transferable.

3. A temporary EMS vehicle permit is not renewable.

4. A temporary EMS vehicle permit shall be affixed on the vehicle to be readily visible and in a location and manner specified by the Office of EMS. An EMS vehicle may not be operated without a properly displayed permit.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-660 Denial of an EMS vehicle permit

A. An application for an EMS vehicle permit shall be denied by the Office of EMS if any conditions of these regulations fail to be met.

B. The Office of EMS will notify the applicant or licensee of the denial in writing in the event that a permit is denied.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-670 Display of EMS vehicle permit

A. An EMS vehicle permit shall be affixed on the EMS vehicle, readily visible, and in a location and manner specified by the Office of EMS.

B. An EMS vehicle may not be operated without a properly displayed EMS vehicle permit.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-680 EMS vehicle advertising

An EMS vehicle may not be marked or lettered to indicate a level of care or type of service other than that for which it is permitted.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-690 Renewal of an EMS vehicle permit

A. Renewal of an EMS vehicle permit may be granted following an inspection if the EMS agency and EMS vehicle comply with these regulations.

B. If the Office of EMS is unable to take action on renewal of an EMS vehicle permit before expiration, the permit will remain in effect until the Office of EMS completes processing of the renewal inspection.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

Article 3 Emergency Medical Services Vehicle Classifications and Requirements

12VAC5-31-700 EMS vehicle safety

Article 3 Emergency Medical Services Vehicle Classifications and Requirements

An EMS vehicle shall be maintained in good repair and safe operating condition and shall meet the same motor vehicle, vessel or aircraft safety requirements as apply to all vehicles, vessels or craft in Virginia:

1. Virginia motor vehicle safety inspection, FAA Airworthiness Permit or Coast Guard Safety Inspection or approved equivalent must be current.

2. Exterior surfaces of the vehicle including windows, mirrors, warning devices and lights shall be kept clean of dirt and debris.

3. Ground vehicle operating weight shall be no more than the manufacturer's gross vehicle weight (GVW) minus 700 pounds (316 kg).

4. Emergency operating privileges including the use of audible and visible emergency warning devices shall be exercised in compliance with the Code of Virginia and local motor vehicle ordinances.

5. The use of any and all tobacco products is prohibited in EMS transport vehicles at all times.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-710 EMS vehicle occupant safety

A. An occupant shall use mechanical restraints as required by the Code of Virginia. Stretcher patients shall be secured on the stretcher utilizing a minimum of three straps unless contraindicated by patient condition.

B. Equipment and supplies in the patient compartment shall be stored within a closed and latched compartment or fixed securely in place while not in use.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-720 EMS vehicle sanitation

The following requirements for sanitary conditions and supplies apply to an EMS vehicle in accordance with standards established by the Centers for Disease Control and Prevention (CDC) and the Virginia Occupational Safety and Health Law:

1. The interior of an EMS vehicle, including storage areas, linens, equipment, and supplies shall be kept clean and sanitary.

2. Linen or disposable sheets and pillowcases or their equivalent used in the transport of patients shall be changed after each use.

3. Blankets, pillows and mattresses used in an EMS vehicle shall be intact and kept clean and in good repair.

4. A device inserted into the patient's nose or mouth that is single-use shall be disposed of after use. A reusable item shall be sterilized or high-level disinfected according to current CDC guidelines before reuse. If not individually wrapped, this item shall be stored in a separate closed container or bag.

5. A used sharp item shall be disposed of in a leakproof, puncture-resistant and appropriately marked biohazard container (needle-safe device/sharps box) that is securely mounted.

6. Following patient treatment/transport within the vehicle and before being occupied by another patient:

a. Contaminated surfaces shall be cleaned and disinfected using a method recommended by the Centers for Disease Control and Prevention.

b. All soiled supplies and used disposable items shall be stored or disposed of in plastic bags, covered containers or compartments provided for this purpose. Regulated waste shall be stored in a red or orange bag or container clearly marked with a biohazard label.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-740 EMS vehicle inspection

A. An EMS vehicle is subject to, and shall be available for, inspection by the Office of EMS or its designee, for compliance with these regulations. An inspection may be in addition to other federal, state or local inspections required for the EMS vehicle by law.

B. The Office of EMS may conduct an inspection at any time without prior notification.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-750 EMS vehicle warning lights and devices

An EMS vehicle shall have emergency warning lights and audible devices as approved by the Superintendent of Virginia State Police, Virginia Department of Game and Inland Fisheries or the Federal Aviation Administration (FAA) as applicable.

1. A ground EMS vehicle shall have flashing or blinking lights installed to provide adequate visible warning from all four sides.

2. A ground EMS vehicle shall have flashing or blinking red or red and white lights installed on or above the front bumper and below the bottom of the windshield.

3. A ground EMS vehicle shall have an audible warning device installed to project sound forward from the front of the EMS vehicle.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-760 EMS vehicle communications

A. An EMS vehicle shall have fixed communications equipment that provides direct two-way voice communications capabilities between the EMS vehicle, other EMS vehicles of the same agency, and either the agency's base of operations (dispatch point) or a governmental public safety answering point (PSAP). This communication capability must be available within the agency's primary service area. Service may be provided by private mobile radio service (PMRS) or by commercial mobile radio service (CMRS), but shall have direct and immediate communications via push-to-talk technology.

B. An ambulance transporting outside its primary service area shall have fixed or portable communications equipment that provides two-way voice communications capabilities between the EMS vehicle and either the agency's base of operations (dispatch point) or PSAP during the period of transport. Service may be provided by private mobile radio service (PMRS) or by commercial mobile radio service (CMRS). When operating outside the agency's area of routine responsibility or in areas where CMRS is not available, the requirement for direct and immediate communications via push-to-talk technology does not apply. If an agency is licensed as a DERA, it is required to have direct and immediate communications via push-to-talk technology for either the agency's base of operations, dispatch point, or PSAP for which the EMS agency vehicle is used for emergency response to the public in the jurisdiction where a memorandum of understanding or memorandum of agreement is in place or is contractually obligated to provide emergency response.

C. An ambulance or an advanced life support-equipped, nontransport response vehicle shall have communications equipment that provides two-way voice communications capabilities between the EMS vehicle's attendant-in-charge and the receiving medical facilities to which it regularly transports or a designated central medical control on one or more of the following frequencies:

155.340 MHz (statewide HEAR);

155.400 MHz (Tidewater HEAR);

155.280 MHZ (Inter-Hospital HEAR);

462.950/467.950 (MED 9 or CALL 1);

462.975/467.975 (MED 10 or CALL 2);

462.950-463.19375/467.950-468.19375 (UHF MED CHANNELS 1-10); and

220 MHz, 700MHz, 800MHz, or 900MHz frequency and designated talkgroup or channel identified as part of an agency, jurisdictional, or regional communications plan for ambulance to hospital communications.

1. Patient care communications with medical facilities may not be conducted on the same frequencies or talkgroups as those used for dispatch and on-scene operations.

2. Before establishing direct push-to-talk communications with the receiving medical facility or central medical control, EMS vehicles may be required to dial an access code. Radios in ambulances or advanced life support-equipped, nontransport response vehicles must be programmed or equipped with encoding equipment necessary to activate tone-coded squelched radios at medical facilities to which they transport on a regular basis.

3. Nothing herein prohibits the use of CMRS for primary or secondary communications with medical facilities, provided that the requirements of this section are met.

D. Mutual aid interoperability. An EMS vehicle must have communications equipment that provides direct two-way voice communications capabilities between the EMS vehicle and EMS vehicles of other EMS agencies within the jurisdiction and those EMS agencies with which it has mutual aid agreements. Service may be provided by private mobile radio service (PMRS) or by commercial mobile radio service (CMRS), but requires direct and immediate communications via push-to-talk technology. This requirement may be met by interoperability on a common radio frequency or talkgroup, or by fixed or interactive cross-patching under supervision of an agency dispatch center or governmental PSAP. The means of communications interoperability must be identified in any mutual aid agreements required by these regulations and must comply with the Virginia Interoperability Plan as defined by the Governor's Office of Commonwealth Preparedness.

E. Air ambulance interoperability. A nontransport EMS vehicle or ground ambulance must have communications equipment that provides direct two-way voice communications capabilities between the EMS vehicle and air ambulances designated to serve its primary response area by the State Medevac Plan. An air ambulance must have fixed communications equipment that provides direct two-way voice communications capabilities between the air ambulance, other EMS vehicles in its primary response area, and public safety vehicles or personnel at landing zones on frequencies adopted in accordance with this section. Radio communications must be direct and immediate via push-to-talk technology. This requirement may be met by interoperability on a common radio frequency or talkgroup, or by fixed or interactive cross-patching under supervision of an agency dispatch center or governmental PSAP. The frequencies used for this purpose will be those set forth by an agreement among air ambulance providers and EMS agencies for a specific jurisdiction or region, and must be identified in agency, jurisdictional, or regional protocols for access and use of air ambulances. Any nontransport EMS vehicle or ground ambulance not participating in such an agreement must be capable of operating on VHF frequency 155.205 MHz (carrier squelch), which is designated as the Statewide EMS Mutual Aid Frequency. An air ambulance must be capable of operating on VHF frequency 155.205 MHz (carrier squelch) in addition to any other frequencies adopted for jurisdictional or regional interoperability.

F. FCC licensure. An EMS agency shall maintain appropriate FCC radio licensure for all radio equipment operated by the EMS agency. If the FCC radio license for any radio frequency utilized is held by another person, the EMS agency shall have written documentation on file of their assigned authority to operate on such frequencies.

G. In-vehicle communications. An ambulance shall have a means of voice communications (opening, intercom, or radio) between the patient compartment and operator's compartment.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-770 Ground EMS vehicle markings

A. The vehicle body of a nontransport response vehicle, a ground ambulance or a neonatal ambulance must be marked with a reflective horizontal band permanently affixed to the sides and rear of the vehicle body. This horizontal reflective band must be of a material approved for exterior use, a minimum of four inches continuous in height.

B. The following must appear in permanently affixed lettering that is a minimum of three inches in height and of a color that contrasts with the surrounding vehicle background. Lettering must comply with the restrictions and specifications listed in these regulations.

1. Nontransport response vehicle. The name of the EMS agency that the vehicle is permitted to shall appear on both sides of the vehicle body in reflective lettering.

Exception: A designated emergency response agency must have the approval of the Office of EMS for a vehicle to display an alternate name.

2. Ground ambulance:

a. The name of the EMS agency that the vehicle is permitted to must appear on both sides of the vehicle body in reflective lettering.

Exception: A designated emergency response agency must have the approval of the Office of EMS for a vehicle to display an alternate name.

b. The word "AMBULANCE" in reverse on the vehicle hood or bug deflector.

c. The word "AMBULANCE" on or above rear doors.

3. Neonatal Ambulance:

a. The name of the EMS agency to which the vehicle is permitted must appear on both sides of the vehicle body in reflective lettering.

b. "NEONATAL CARE UNIT" or other similar designation, approved by the Office of EMS, must appear on both sides of the vehicle body.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-780 Air Ambulance markings

A. On a primary air ambulance, the following must appear in permanently affixed lettering that is a minimum of three inches in height and of a color that contrasts with its surrounding background. Lettering must comply with the restrictions and specifications listed in these regulations.

1. The name of the EMS agency that the aircraft is permitted to must appear on both sides of the aircraft body. This lettering may appear as part of an organization logo or emblem as long as the agency name appears in letters of the required height.

Exception: A Designated Emergency Response Agency must have the approval of the Office of EMS for a vehicle to display an alternate name.

2. Agency or FAA assigned unit/vehicle identification number must appear on both sides of the aircraft.

B. The Star of Life emblem may appear on an air ambulance. If used, the emblem (14-inch size minimum) shall appear on both sides, and/or front and rear of the air ambulance.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-790 EMS vehicle letter restrictions and specifications

A. The EMS agency name must appear in lettering larger than any optional lettering on an EMS vehicle, other than "Ambulance," the unit identification number, or any lettering on the roof. Optional lettering, logos, or emblems may not appear on an EMS vehicle in a manner that interferes with the public's ability to readily identify the EMS agency to which the EMS vehicle is permitted.

1. Additional lettering, logos, or emblems must not advertise or imply a specified patient care level (i.e., Advanced Life Support Unit) unless the EMS vehicle is so equipped at all times.

2. The terms "Paramedic" or "Paramedical" may only be used when the EMS vehicle is both equipped and staffed by a state-certified paramedic at all times.

B. Notwithstanding the provisions of subsection A of this section, an EMS vehicle of a combination fire department and EMS agency operating under a single EMS agency license, in accordance with established policies for identifying both the EMS agency license holder and the fire department, may display a fire department logo or lettering larger than the lettering identifying the EMS agency name.

C. A nontransport response vehicle with a primary purpose as a fire apparatus or law-enforcement vehicle is not required to comply with the specifications for vehicle marking and lettering, provided the vehicle is appropriately marked and lettered to identify it as an authorized emergency vehicle.

D. An unmarked vehicle operated by an EMS agency is not eligible for issuance of an EMS vehicle permit except a vehicle used and operated by law-enforcement personnel.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012; Volume 42, Issue 5, eff. November 19, 2025.

12VAC5-31-800 Nontransport response vehicle specifications

A. A vehicle maintained and operated for response to the location of a medical emergency to provide immediate medical care at the basic or advanced life support level (excluding patient transport) shall be permitted as a nontransport response vehicle.

A nontransport response vehicle may not be used for the transportation of patients except in the case of a major medical emergency. In such an event, the circumstances of the call shall be documented.

B. A nontransport response vehicle must be constructed to provide sufficient space for safe storage of required equipment and supplies specified in these regulations.

A nontransport response vehicle used for the delivery of advanced life support must have a locking storage compartment or approved locking bracket for the security of drugs and drug kits. When not in use, drugs and drug kits must be kept locked in the required storage compartment or approved bracket at all times. The EMS agency shall maintain drugs and drug kits as specified in these regulations.

1. Sedan/zone car must have an approved locking device attached within the passenger compartment or trunk, inaccessible by the public.

2. Utility vehicle/van must have an approved locking device attached within the vehicle interior, inaccessible by the public.

3. Rescue vehicle/fire apparatus must have an approved locking device attached within the vehicle interior or a locked compartment, inaccessible by the public.

C. A nontransport response vehicle must have a motor vehicle safety inspection performed following completion of conversion and before applying for an EMS vehicle permit.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-810 Ground ambulance specifications

A. A vehicle maintained and operated for response to the location of a medical emergency to provide immediate medical care at the basic or advanced life support level and for the transportation of patients shall be permitted as a ground ambulance.

B. A ground ambulance must be commercially constructed and certified to comply with the current federal specification for the Star of Life ambulance (U.S. General Services Administration KKK-A-1822 standards) as of the date of vehicle construction, with exceptions as specified in these regulations.

C. A ground ambulance must be constructed to provide sufficient space for the safe storage of all required equipment and supplies. A ground ambulance must have a locking interior storage compartment or approved locking bracket used for the secure storage of drugs and drug kits that is accessible from within the patient compartment. Drugs and drug kits must be kept in a locked storage compartment or approved bracket at all times when not in use. The EMS agency must maintain drugs and drug kits as specified in these regulations.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-820 Advanced life support equipment package

A. An EMS agency licensed to operate nontransport response vehicles or ground ambulances with ALS personnel shall maintain a minimum of one vehicle equipped with an ALS equipment package of the highest category licensed. ALS equipment packages consist of the following categories:

1. ALS – EMT-enhanced equipment package; and

2. ALS – Advanced-EMT/Intermediate/Paramedic equipment package.

B. ALS equipment packages shall consist of the equipment and supplies as specified in these regulations.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-830 Neonatal ambulance specifications

A. A vehicle maintained and operated exclusively for the transport of neonatal patients between medical facilities shall be permitted as a neonatal ambulance. A neonatal ambulance shall not be used for response to out-of-hospital medical emergencies.

B. A neonatal ambulance must be commercially constructed and certified to comply with the current U.S. General Services Administration KKK-A-1822 standards as of the date of vehicle construction.

C. A neonatal ambulance must be constructed to provide sufficient space for safe storage of required equipment and supplies specified in these regulations.

1. A neonatal ambulance must be equipped to transport two incubators using manufacturer-approved vehicle mounting devices.

2. A neonatal ambulance must have an installed auxiliary power unit that is capable of supplying a minimum of 1.5 Kw of 110VACelectric power. The auxiliary power unit must operate independent of the vehicle with starter and power controls located in the patient compartment.

3. A neonatal ambulance must have a locking interior storage compartment or approved locking bracket used for the secure storage of drugs and drug kits that is accessible from within the patient compartment. Drugs and drug kits must be kept in a locked storage compartment or approved bracket at all times when not in use. The EMS agency must maintain drugs and drug kits as specified in these regulations.

4. Required equipment and supplies specified in these regulations must be available for access and use from inside the patient compartment.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-840 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-850 EMS vehicle equipment requirements

In addition to the items otherwise listed in this article, an EMS vehicle must be equipped with all of the items required for its vehicle classification and any ALS equipment package it carries as listed in 12VAC5-31-860.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-860 Required vehicle equipment

A. A nontransport vehicle shall carry the following:

1. Basic life support equipment.

a. Automated external defibrillator (AED) with two sets of patient pads. This may be a combination device that also has manual defibrillation capability (1).

b. Pocket mask or disposable airway barrier device with one-way valve (2).

c. Oropharyngeal airways set of six, nonmetallic in infant, child, and adult sizes ranging from 43mm to 100mm (sizes 0-5) (1 each).

d. Nasopharyngeal airways set of four, varied sizes, with water soluble lubricant (1).

e. Self-inflating bag-valve-mask resuscitation with oxygen reservoir in adult size with transparent mask in adult and child sizes (1).

f. Self-inflating bag-valve-mask resuscitation with oxygen reservoir in infant size with transparent masks in infant size (1).

2. Oxygen apparatus.

a. Portable oxygen unit containing a quantity of oxygen sufficient to supply the patient at the approximate flow rate for the period of time it is anticipated oxygen will be needed but not less than 10 liters per minute for 15 minutes. The unit must be capable of being manually controlled and have an appropriate flowmeter (1).

b. High concentration oxygen masks, 80% or higher delivery, in child and adult sizes. These masks must be made of single use soft see-through plastic or rubber (2 each).

c. Oxygen nasal cannula in child and adult sizes. This cannula must be made of single use soft see-through plastic or rubber (2 each).

3. Suction apparatus.

a. Battery powered portable suction apparatus. A manually powered device does not meet this requirement (1).

b. Suction catheters that are sterile, individually wrapped, disposable, and made of rubber or plastic in sizes as follows: Rigid tonsil tip, FR18, FR14, FR8 and FR6 (2 each).

4. Patient assessment equipment.

a. Stethoscope in adult size (1).

b. Stethoscope in pediatric size (1).

c. Sphygmomanometer in child, adult, and large adult sizes (1 each).

d. Vinyl triage tape rolls of red, black, green, and yellow (1 each).

e. 25 OEMS approved triage tags.

f. Penlight (1).

g. Medical protocols (1).

5. Dressing and supplies.

a. First aid kit of durable construction and suitably equipped. The contents of this kit may be used to satisfy these supply requirements completely or in part (1).

b. Trauma dressings, a minimum of 8" x 10" - 5/8 ply when folded, sterile and individually wrapped (4).

c. 4" x 4" gauze pads, sterile and individually wrapped (24).

d. Occlusive dressings, sterile 3" x 8" or larger (4).

e. Roller or conforming gauze of assorted widths (12).

f. Cloth triangular bandages, 36" x 36" x 51", triangle unfolded (10).

g. Medical adhesive tape, rolls of 1" and 2" (4).

h. Trauma scissors (1).

i. Emesis basin containers or equivalents (2).

j. Sterile normal saline for irrigation, 1000 ml containers (or equivalent volume in other container sizes) (1).

k. Oral glucose (1).

6. Obstetrical kit (one). It must contain the following:

a. Pairs of sterile surgical gloves (2).

b. Scissors or other cutting instrument (1).

c. Umbilical cord ties (10" long) or disposable cord clamps (4).

d. Sanitary pads (1).

e. Cloth or disposable hand towels (2).

f. Soft-tipped bulb syringe (1).

7. Personal protection equipment.

a. Waterless antiseptic hand wash (1).

b. Exam gloves, nonsterile, pairs in sizes small though extra large (5 each).

c. Disposable gowns or coveralls, each in assorted sizes if not one size fits all style (2).

d. Face shield or eyewear (2).

e. Infectious waste trash bags (2).

8. Linen and bedding.

a. Towels, cloth (2).

b. Blankets (2).

9. Splints and immobilization devices.

Rigid cervical collars in sizes small adult, medium adult, large adult, and pediatric (2 each). If adjustable type collars are used, then a minimum of three are sufficient.

10. Safety equipment.

a. "D" cell battery or larger flashlight (1).

b. Five-pound Class ABC or equivalent fire extinguisher securely mounted in the vehicle in a quick release bracket (1).

c. Safety apparel (2).

d. Sharps container (1).

11. Tools and hazard warning devices.

a. Adjustable wrench, 10" (1).

b. Screwdriver, regular #1 size blade (1).

c. Screwdriver, Phillips #1 size blade (1).

d. Spring loaded center punch (1).

e. Hazard warning devices such as a reflective cone, triangle, or approved equivalent (3 each).

f. Current USDOT approved Emergency Response Guidebook (1).

B. A ground ambulance shall carry the following:

1. Basic life support equipment.

a. Automated external defibrillator (AED) with two sets of patient pads. This may be a combination device that also has manual defibrillation capability (1).

b. Pocket mask or disposable airway barrier device with one-way valve (2).

c. Oropharyngeal airways set of six, nonmetallic in infant, child, and adult sizes ranging from 43mm to 100mm (sizes 0-5) (1 each).

d. Nasopharyngeal airways set of four, varied sizes, with water soluble lubricant (1).

e. Self-inflating bag-valve-mask resuscitation with oxygen reservoir in adult size with transparent mask in adult and child sizes (1 each).

f. Self-inflating bag-valve-mask resuscitation with oxygen reservoir in infant size with transparent masks in infant size (1).

2. Oxygen apparatus.

a. Portable oxygen unit containing a quantity of oxygen sufficient to supply the patient at the approximate flow rate for the period of time it is anticipated oxygen will be needed but not less than 10 liters per minute for 15 minutes. The unit must be capable of being manually controlled and have an appropriate flowmeter (1).

b. Installed oxygen system containing a sufficient quantity of oxygen to supply two patient flowmeters at the appropriate flow rate for the period of time it is anticipated oxygen will be needed but not less than 10 liters per minute for 30 minutes. This unit must be capable of being manually controlled, have two flowmeters, and have an attachment available for a single-use humidification device (1).

c. High concentration oxygen masks, 80% or higher delivery, in child and adult sizes. These masks must be made of single use soft see-through plastic or rubber (4 each).

d. Oxygen nasal cannula in child and adult sizes. This cannula must be made of single use soft see-through plastic or rubber (4 each).

3. Suction apparatus.

a. Battery powered portable suction apparatus. A manually powered device does not meet this requirement (1).

b. Installed suction apparatus capable of providing a minimum of 20 minutes of continuous operation (1).

c. Suction catheters that are sterile, individually wrapped, disposable, and made of rubber or plastic in sizes as follows: Rigid tonsil tip, FR18, FR14, FR8 and FR6 (2 each).

4. Patient assessment equipment.

a. Stethoscope in adult size (2).

b. Stethoscope in pediatric size (1).

c. Sphygmomanometer in child, adult, and large adult sizes (1 each).

d. Vinyl triage tape rolls of red, black, green, and yellow (1 each).

e. 25 OEMS approved triage tags.

f. Penlight (1).

g. Medical protocols (1).

5. Dressing and supplies.

a. First aid kit of durable construction and suitably equipped. The contents of this kit may be used to satisfy these supply requirements completely or in part (1).

b. Trauma dressings, a minimum of 8" x 10" - 5/8 ply when folded, sterile and individually wrapped (four).

c. 4" x 4" gauze pads, sterile and individually wrapped (24).

d. Occlusive dressings, sterile 3" x 8" or larger (4).

e. Roller or conforming gauze of assorted widths (12).

f. Cloth triangular bandages, 36" x 36" x 51", triangle unfolded (10).

g. Medical adhesive tape, rolls of 1" and 2" (4).

h. Trauma scissors (1).

i. Alcohol preps (12).

j. Emesis basin containers or equivalents (2).

k. Sterile normal saline for irrigation, 1000 ml containers (or equivalent volume in other container sizes) (4).

l. Oral glucose (2).

6. Obstetrical kit (2). It must contain the following:

a. Pairs of sterile surgical gloves (2).

b. Scissors or other cutting instrument (1).

c. Umbilical cord ties (10" long) or disposable cord clamps (4).

d. Sanitary pads (1).

e. Cloth or disposable hand towels (2).

f. Soft-tipped bulb syringe (1).

7. Personal protection equipment.

a. Waterless antiseptic hand wash (1).

b. Exam gloves, nonsterile, pairs in sizes small though extra large (10 each).

c. Disposable gowns or coveralls, each in assorted sizes if not one size fits all style (4).

d. Face shield or eyewear (4).

e. Infectious waste trash bags (4).

8. Linen and bedding.

a. Towels, cloth (2).

b. Pillows (2).

c. Pillow cases (2).

d. Sheets (4).

e. Blankets (2).

f. Male urinal (1).

g. Bedpan with toilet paper (1).

9. Splints and immobilization devices.

a. Rigid cervical collars in sizes small adult, medium adult, large adult, and pediatric (3 each). If adjustable type collars are used, then a minimum of three are sufficient.

b. Traction splint with ankle hitch and stand in adult and pediatric size (1 each) or an equivalent traction splint device capable of adult and pediatric application.

c. Padded board splints or equivalent for splinting fractures of the upper extremities (2).

d. Padded board splints or equivalent for splinting fractures of the lower extremities (2).

e. Long spine boards 16" x 72" minimum size with at least four appropriate restraint straps, cravats, or equivalent restraint devices for each spine board (2).

f. Short spine board 16" x 34" minimum size or equivalent spinal immobilization devices (1).

g. Pediatric immobilization device (1).

h. Cervical immobilization devices (i.e., set of foam blocks, towels or other approved materials) (2).

10. Safety equipment.

a. Wheeled ambulance cot with a minimum 350 lb. capacity, three restraint straps, and the manufacturer-approved vehicle mounting device (1).

b. "D" cell battery or larger flashlight (2).

c. Five-pound Class ABC or equivalent fire extinguisher securely mounted in the vehicle in a quick release bracket. One must be accessible to the patient compartment (2).

d. Safety apparel (2).

e. Sharps container, mounted or commercially secured (1).

f. "No Smoking" sign located in the patient compartment (1).

11. Tools and hazard warning devices.

a. Adjustable wrench, 10" (1).

b. Screwdriver, regular #1 size blade (1).

c. Screwdriver, Phillips #1 size blade (1).

d. Spring loaded center punch (1).

e. Hazard warning device (i.e., reflective cone, triangle, or approved equivalent) (3 total).

f. Current USDOT approved Emergency Response Guidebook (1).

C. A neonatal ambulance shall carry the following:

1. Basic life support equipment.

a. Pocket mask or disposable airway barrier device with one-way valve (2).

b. Oropharyngeal airways set of six, nonmetallic in infant, child, and adult sizes ranging from 43mm to 100mm (sizes 0-5) (2 each).

c. Nasopharyngeal airways set of four, varied sizes, with water soluble lubricant (1).

d. Self-inflating bag-valve-mask resuscitation with oxygen reservoir in adult size with transparent mask in adult size (1).

e. Self-inflating bag-valve-mask resuscitation with oxygen reservoir in child size with transparent masks in child size (1).

f. Self-inflating bag-valve-mask resuscitation with oxygen reservoir in infant size with transparent masks in infant size (1).

2. Oxygen apparatus.

a. Portable oxygen unit containing a quantity of oxygen sufficient to supply the patient at the approximate flow rate for the period of time it is anticipated oxygen will be needed but not less than 10 liters per minute for 15 minutes. The unit must be capable of being manually controlled and have an appropriate flowmeter (1).

b. Installed oxygen system containing a sufficient quantity of oxygen to supply two patient flowmeters at the appropriate flow rate for the period of time it is anticipated oxygen will be needed but not less than 10 liters per minute for 30 minutes. This unit must be capable of being manually controlled, have two flowmeters, and have an attachment available for a single-use humidification device (1).

c. High concentration oxygen masks, 80% or higher delivery, in child and adult sizes. These masks must be made of single use soft see-through plastic or rubber (4 each).

d. Oxygen nasal cannula in child and adult sizes. This cannula must be made of single use soft see-through plastic or rubber (4 each).

3. Suction apparatus.

a. Battery-powered portable suction apparatus. A manually powered device does not meet this requirement (1).

b. Installed suction apparatus capable of providing a minimum of 20 minutes of continuous operation (1).

c. Suction catheters that are sterile, individually wrapped, disposable, and made of rubber or plastic in sizes as follows: Rigid tonsil tip, FR18, FR14, FR8 and FR6 (2 each).

4. Patient assessment equipment.

a. Stethoscope in adult size (1).

b. Stethoscope in pediatric size (1).

c. Stethoscopes in infant and neonate sizes (2 each).

d. Sphygmomanometer in child, adult, and large adult sizes (1 each).

e. Sphygmomanometer in infant size (2).

5. Dressing and supplies.

a. First aid kit of durable construction and suitably equipped. The contents of this kit may be used to satisfy these supply requirements completely or in part (1).

b. Trauma dressings, a minimum of 8" x 10" - 5/8 ply when folded, sterile and individually wrapped (4).

c. 4" x 4" gauze pads, sterile and individually wrapped (24).

d. Occlusive dressings, sterile 3" x 8" or larger (4).

e. Roller or conforming gauze of assorted widths (12).

f. Medical adhesive tape, rolls of 1" and 2" (4).

g. Trauma scissors (1).

h. Alcohol preps (12).

i. Emesis basin containers or equivalents (2).

j. Sterile normal saline for irrigation, 1000 ml containers (or equivalent volume in other container sizes) (4).

6. Obstetrical kit (2). It must contain the following:

a. Pairs of sterile surgical gloves (2).

b. Scissors or other cutting instrument (1).

c. Umbilical cord ties (10" long) or disposable cord clamps (4).

d. Sanitary pads (1).

e. Cloth or disposable hand towels (2).

f. Soft-tipped bulb syringe (1).

7. Personal protection equipment.

a. Waterless antiseptic hand wash (1).

b. Exam gloves, nonsterile, pairs in sizes small though extra large (10 each).

c. Disposable gowns or coveralls, each in assorted sizes if not one size fits all style (4).

d. Face shield or eyewear (4).

e. Infectious waste trash bags (4).

8. Linen and bedding.

a. Towels, cloth (2).

b. Sheets (4).

c. Blankets (2).

9. Splints and immobilization devices.

a. Rigid cervical collars in sizes small adult, medium adult, large adult, and pediatric (2 each). If adjustable type collars are used, then a minimum of three are sufficient.

b. Pediatric immobilization device (1).

10. Safety equipment.

a. "D" cell battery or larger flashlight (2).

b. Five-pound Class ABC or equivalent fire extinguisher securely mounted in the vehicle in a quick release bracket. One must be accessible to the patient compartment (2).

c. Safety apparel (2).

d. Sharps container, mounted or commercially secured (1).

e. "No Smoking" sign located in the patient compartment (1).

11. Tools and hazard warning devices.

a. Adjustable wrench, 10" (1).

b. Screwdriver, regular #1 size blade (1).

c. Screwdriver, Phillips #1 size blade (1).

d. Spring loaded center punch (1).

e. Hazard warning devices (reflective cone, triangle or approved equivalent) (3 each).

f. Current USDOT approved Emergency Response Guidebook (1).

D. Advanced life support equipment package.

1. EMT-Enhanced package.

a. Drug kit with all controlled drugs authorized for use by the EMS agency's EMT-Enhanced personnel and other appropriately certified advanced level personnel. The drug kit may contain additional drugs if the kit is a standardized box utilized by multiple EMS agencies operating under a joint drug exchange program (1).

b. Assorted intravenous, intramuscular, subcutaneous, and other drug delivery devices and supplies as specified by the agency OMD (1).

2. Advanced-EMT/Intermediate/Paramedic package.

a. Electrocardiogram (ECG) monitor and manual defibrillator capable of synchronized cardioversion and noninvasive external pacing with capability for monitoring and defibrillating adult and pediatric patients (1).

b. ECG monitoring electrodes in adult and pediatric sizes as required by device used. (2 sets each).

c. Defibrillation and pacing electrodes in adult and pediatric sizes as required by device used (2 sets each).

d. Drug kit with all controlled drugs authorized for use by the EMS agency's Advanced EMT, Intermediate, Paramedic and other authorized licensed personnel. The drug kit may contain additional drugs if the kit is a standardized box utilized by multiple EMS agencies operating under a joint drug exchange program (1).

e. Assorted intravenous, intramuscular, subcutaneous, and other drug delivery devices and supplies as specified by the agency OMD (1).

f. Pediatric assessment guides.

3. Neonatal ambulance.

a. ECG monitor and manual defibrillator capable of synchronized cardioversion and noninvasive external pacing with capability for monitoring and defibrillating adult and pediatric patients (1).

b. ECG monitoring electrodes in infant size as required by device used (2 sets).

c. Defibrillation and pacing electrodes in adult and pediatric sizes as required by device used (2 sets each).

d. Drug kit with all controlled drugs authorized for use by the EMS agency's Advanced EMT, Intermediate, Paramedic and other authorized licensed personnel. The drug kit may contain additional drugs if the kit is a standardized box utilized by multiple EMS agencies operating under a joint drug exchange program (1).

e. Assorted intravenous, intramuscular, subcutaneous, and other drug delivery devices and supplies as specified by the agency OMD (1).

4. Advanced airway equipment (EMT-Enhanced, Advanced EMT, Intermediate/Paramedic package).

a. Secondary airway device (e.g., combitube type or supra-glottic devices) or laryngeal mask airway (LMA) (one).

b. Intubation kit to include all of the following items as indicated:

(1) Laryngoscope handle with two sets of batteries, adult and pediatric blades in sizes 0-4 (1 set each).

(2) Magill forceps in adult and pediatric sizes (1 each).

(3) Single use disposable endotracheal tubes in sizes 8.0, 7.0, 6.0, 5.0, 4.0, 3.0, and 2.5m or equivalent sizes (2 each).

(4) Rigid adult stylettes (2).

(5) 10 cc disposable syringes (2).

(6) 5 ml of water soluble surgical lubricant (1).

(7) Secondary confirmation device such as esophageal detection devices, colorimetric evaluation devices, or equivalent (2).

5. Advanced airway neonatal equipment. Intubation kit to include all of the following items as indicated:

a. Laryngoscope handle with two sets of batteries, blades in sizes 0-1 (1 set each).

b. Single-use disposable endotracheal tubes in sizes 4.0, 3.0, and 2.5mm or equivalent sizes (2 each).

c. 10 cc disposable syringes (2).

d. 5 ml of water soluble surgical lubricant (1).

e. Secondary confirmation device such as esophageal detection devices, colorimetric evaluation devices, or equivalent (2).

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

Article 4 Air Medical Regulations, Rotor and Fixed Wing Operations

12VAC5-31-870 Application for agency licensure

Article 4 Air Medical Regulations, Rotor and Fixed Wing Operations

A. General provisions. Air medial public service agencies will meet or exceed Federal Aviation Regulations, 14 CFR Part 91, and commercial operators will meet or exceed 14 CFR Part 135.

B. Interruption of service (rotor wing only). The air medical service shall notify the Office of EMS of temporary discontinuation of service from any base expected to last 24 hours or greater.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-875 Operations and safety

Operational policies must be present to address the following areas pursuant to medical flight personnel:

1. Hearing protection.

2. Protective clothing and dress codes relative to:

a. Mission type; and

b. Infection control.

3. Flight status during pregnancy.

4. Flight status during acute illness.

5. Flight status while taking medications.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-880 Air medical service personnel classifications

Air medical service personnel classifications are as follows:

1. Air medical crew (rotary).

a. A pilot-in-command in accordance with current Federal Aviation Administration (FAA) requirements.

b. An attendant-in-charge shall be an air medical specialist who must be one of the following:

(1) Physician;

(2) Registered nurse or physician assistant, licensed for a minimum of two years with specialized air medical training and possessing the equivalent training as identified in 12VAC5-31-885;

(3) Paramedic, certified for a minimum of two years with specialized air medical training; or

(4) Other health care personnel with equivalent training or experience as approved by the Office of EMS.

c. An attendant shall have specialized air training as identified in 12VAC5-31-885.

2. Air medical crew (fixed wing).

a. A pilot-in-command in accordance with current FAA requirements.

b. An attendant-in-charge shall be an air medical specialist who shall be one of the following:

(1) A physician;

(2) A registered nurse or physician assistant licensed for a minimum of two years with specialized air medical training;

(3) An emergency medical technician certified for a minimum of two years with specialized air medical training; or

(4) Any other health care personnel with equivalent training or experience as approved by the Office of EMS.

c. An attendant shall be a Paramedic or an equivalent approved by the Office of EMS.

3. Specialty care mission providers.

a. The agency shall have in place policies that identify the crew composition for each specialty mission type that it is willing to perform and are consistent with industry standards. These policies shall be approved by the agency OMD and have a method of continuously monitoring adherence to those policies.

b. The specialty care team must minimally consist of a physician, registered nurse or other specialists as the primary caregiver whose expertise must be consistent with the needs of the patient, per the agency's policy required in subdivision 3 a of this section.

c. All specialty care team members must have received an orientation to the air medical service that includes (i) in-flight treatment protocols, (ii) general aircraft safety and emergency procedures, (iii) operational policies, (iv) infection control, and (v) altitude physiology annually.

d. Specialty care mission personnel must be accompanied by at least one regularly scheduled air medical staff member of the air medical service.

4. Staffing for specific mission types.

a. Prehospital scene responses - consists of the pilot-in-command, attendant-in-charge who shall be a Paramedic and an attendant.

b. Inter-facility transports.

(1) ALS - consists of the pilot-in-command, attendant-in-charge, and an attendant.

(2) For fixed wing, the attendant may be a BLS provider.

(3) Critical care - consists of the pilot-in-command, attendant-in-charge, and an attendant. A member of the medical crew shall be a physician, physician assistant, or a registered nurse.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-885 Training

A. The air medical agency shall have a planned and structured program in which all medical transport personnel must participate. Competency and currency must be ensured and documented through relevant continuing education programs or certification programs listed in this section. Training and continuing education programs will be guided by each air medical transport service's mission statement and medical direction. Measurable objectives shall be developed and documented for each experience.

B. Pilot initial training requirements. In addition to FAA requirements pilots must have the following:

1. Orientation to the hospital or health care system associated with the air medical service.

2. Orientation to infection control, medical systems installed on the aircraft, and patient loading and unloading procedures.

3. Orientation to the EMS and public service agencies unique to the specific coverage area (fixed wing excluded).

C. Registered nurse training requirements.

1. Valid unrestricted license to practice nursing in Virginia.

2. Cardio-Pulmonary Resuscitation (CPR) - documented evidence of current CPR certification according to the American Heart Association (AHA) standards or equivalent as approved by OEMS.

3. Advanced Cardiac Life Support (ACLS) - documented evidence of current ACLS according to the AHA or equivalent as approved by OEMS.

4. Pediatric Advanced Life Support (PALS) - documented evidence of current PALS or equivalent education.

5. Neonatal Resuscitation Program (NRP) - documented evidence of current NRP according to the AHA or American Academy of Pediatrics (AAP) or equivalent education within one year of hire. (fixed wing, mission specific).

6. EMT or equivalent education within six months of hire (fixed wing excluded).

D. Paramedic training requirements.

1. Valid Virginia Paramedic certification.

2. CPR - documented evidence of current CPR certification according to the AHA standards or equivalent as approved by OEMS.

3. ACLS - documented evidence of current ACLS certification according to the AHA or equivalent as approved by OEMS.

4. PALS - documented evidence of current PALS or equivalent education.

5. NRP - documented evidence of current NRP according to the AHA or AAP or equivalent education. (fixed wing, mission specific).

E. Minimum initial training for air medical crew members.

1. Didactic component of initial education - shall be specific for the mission statement and scope of care of the medical transport service. Measurable objectives shall be developed and documented for each experience by the program.

Minimum training for all air medical crew members, including the OMD, shall include:

a. Altitude physiology and stressors of flight.

b. Air medical resource management.

c. Aviation - aircraft orientation, safety, in-flight procedures, and general aircraft safety including depressurization procedures for fixed wing.

d. Cardiology.

e. Disaster and triage.

f. EMS radio communications.

g. Hazardous materials recognition and response.

h. External pacemakers, automatic implantable cardiac defibrillator (AICD), and central lines.

i. High risk obstetric emergencies (bleeding, medical, trauma).

j. Infection control.

k. Mechanical ventilation and respiratory physiology for adult, pediatric, and neonatal patients as it relates to the mission statement and scope of care of the medical transport service specific to the equipment.

l. Metabolic or endocrine emergencies.

m. Multi-trauma (adult trauma and burns).

n. Neuro.

o. Pediatric medical emergencies.

p. Pediatric trauma.

q. Pharmacology (specialty application).

r. Quality management - didactic education that supports the medical transport services mission statement and scope of care of the medical transport service.

s. Respiratory emergencies.

t. Scene management, rescue and extrication.

u. Survival training.

v. Toxicology.

2. Additional training for critical care air medical crew members, including paramedics, RNs, MDs, and the air medical services OMD shall include within their mission profile:

a. Hemodynamic monitoring.

b. Intra-aortic balloon pump.

c. Pulmonary and arterial catheters.

d. Ventricular assist devices.

e. Extracorporeal membrane oxygenation (ECMO).

3. Clinical component of initial education. Clinical experiences shall include the following points (experiences shall be specific to the mission statement and scope of care of the medical transport service). Measurable objectives shall be developed and documented for each experience listed below reflecting hands-on experience versus observation only (fixed wing excluded).

a. Advanced airway management.

b. Basic care for pediatrics, neonatal and obstetrics.

c. Critical care.

d. Emergency care.

e. Invasive procedures on mannequin equivalent for practicing invasive procedures.

f. Pediatric critical care.

g. Prehospital care.

4. Annual continuing education requirements. Continuing education or staff development programs shall include reviews or updates for all air medical crew members and the agency OMD on the following areas:

a. Aviation safety issues.

b. Altitude physiology.

c. Air medical resource management.

d. Hazardous materials recognition and response.

e. Invasive procedures labs.

f. Management of emergency or critical care adults, pediatric, and neonatal patients (medical and trauma).

g. Survival training.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-890 Equipment

A. Aircraft equipment.

1. General aircraft inspection requirements.

a. Current FAA documented compliance.

b. Current EMS permit posted.

c. Interior and supplies clean and sanitary.

d. Exterior clean.

e. Equipment in good working order.

f. Current USDOT Emergency Response Book.

2. Aircraft warning devices.

180 degree controllable searchlight 400,000 candle power (fixed wing excluded).

3. Design and dimensions.

a. All interior edges and corners padded.

b. Surfaces easily cleaned and nonstainable.

c. Security restraints for stretcher to aircraft.

d. Climate controlled environment for operator and patient care compartments.

e. The service's mission and ability to transport two or more patients shall not compromise the airway or stabilization or the ability to perform emergency procedures on any on-board patient.

4. Aircraft markings.

a. Lettering is minimum three inches in height.

b. Name of agency aircraft is permitted on both sides, three inches in height, contrasting color.

5. Aircraft communications.

a. The aircraft shall be equipped with a functioning emergency locator transmitter (ELT).

b. Attendant-in-charge to medical control (fixed wing excluded).

c. Patient compartment to pilot.

d. The pilot must be able to control and override radio transmissions from the cockpit in the event of an emergency situation.

e. The flight crew must be able to communicate internally.

f. Cellular phones may not be used to satisfy these requirements.

6. Aircraft safety equipment.

a. Head strike envelope - Helmets shall be worn by all routine flight crews and scheduled specialty teams.

b. Seatbelts for all occupants.

c. Flashlight.

d. Fire extinguisher mounted in a quick release bracket or other FAA approved fire suppression system.

e. All items secured to prevent movement while the air ambulance is in motion.

f. "No Smoking" sign posted.

g. The aircraft shall be equipped with survival gear specific to the coverage area and the number of occupants.

h. Survival kit to include signaling capabilities and shelter.

i. Safety apparel. (3 minimum)

j. All items shall be capable of being secured.

B. Medical equipment. Any in-service air ambulance shall be configured in such a way that the medical transport personnel can provide patient care consistent with the mission statement and scope of care of the medical transport service.

1. General patient care equipment.

a. A minimum of one stretcher shall be provided that can be carried to the patient and properly secured to the aircraft as defined in FAR 27.785.

(1) The stretcher shall be age appropriate and full length in the supine position.

(2) The stretcher shall be sturdy and rigid enough that it can support cardiopulmonary resuscitation. If a backboard or equivalent device is required to achieve this, such device will be readily available. (1)

(3) The head of the stretcher shall be capable of being elevated for patient care and comfort.

b. Biohazard container for contaminated sharp objects (ALS), secured or mounted. (1)

c. Waterless antiseptic hand wash. (1)

d. Exam gloves, nonsterile, pairs in sizes small through extra large (small, medium, large, and extra large), if not one size fits all. (5)

e. Face shield or eyewear. (2)

f. Infectious waste trash bags. (2)

g. Linen: towels, blankets, and sheets. (2 each)

2. Basic life support air ambulance equipment requirements.

a. Roller or conforming gauze of assorted widths. (12)

b. Medical adhesive tape, rolls of 1" and 2". (4)

c. Trauma scissors. (1)

d. Trauma dressings, minimum of 8" x 10"-5/8 ply, sterile, individually wrapped. (2)

e. Sterile 4" x 4" gauze pads, individually wrapped. (10)

f. Occlusive dressings, sterile 3" x 8" or larger. (2)

g. Oropharyngeal airways, one of each sizes 0-5 wrapped or in closed container. (1 set)

h. Nasopharyngeal airways set of four, varied sizes, with water soluble lubricant. (1 set)

i. Bag valve mask with oxygen attachment, adult size, with transparent mask. (1)

j. Bag valve mask with oxygen attachment, child size, with transparent mask. (1)

k. BVM infant mask. (1)

l. Pocket mask. (1)

m. Portable O₂ unit containing a quantity of oxygen sufficient to supply the patient at the appropriate flow rate for the period of time it is anticipated oxygen will be needed but not less than 10 liters per minute for 15 minutes. The unit must be manually controlled and have an approved flow meter.

n. Installed oxygen system containing a sufficient quantity of oxygen to supply two patient flowmeters at the approximate flow rate for the period of time it is anticipated oxygen will be needed, but not less than 10 liters per minute for 30 minutes. This unit must be capable of being manually controlled, have two flowmeters, and have an attachment available for a single use humidification device.

o. O₂ high concentrate mask and cannula, child and adult. (2 each)

p. Installed suction apparatus capable of providing a minimum of 20 minutes of continuous operation. (1)

q. Battery powered portable suction apparatus. A manually powered device does not meet this requirement. (1)

r. Suction catheters, wrapped, rigid tonsil tip, FR18, FR14, FR8 and FR6. (2 each)

s. Stethoscope, adult, and pediatric sizes. (1 each)

t. BP cuff, pediatric, adult, and large adult. (1 each)

u. Obstetrics kit containing sterile surgical gloves (2 pair), scissors or other cutting instrument (1), umbilical cord ties (10" long) or disposable cord clamps (4), sanitary pad (1), cloth or disposable hand towels (2), and soft tip bulb syringe (1).

v. Emesis basin or equivalent container. (2)

w. Removable stretcher or spine board with a minimum of 3 restraint straps and manufacturer approved aircraft mounting device. (1)

x. Rigid cervical collars in small adult, medium adult, large adult, and pediatric sizes (1 each). If adjustable adult collars are utilized, a minimum of three.

y. Cervical immobilization device. (1)

z. Pediatric immobilization device. (1)

aa. Immobilization devices for upper and lower extremities. (1 each)

bb. First aid kit of durable construction and suitably equipped. The contents of this kit may be used to satisfy these supply requirements completely or in part. (1)

3. Advanced life support air ambulance equipment requirements.

a. A drug kit with controlled medications authorized by the agency's OMD for use by paramedic personnel. (1)

b. Lockable storage for drug kit and supplies.

c. All drugs shall be in date.

d. Intubation kit with two sets of batteries, adult and pediatric blades and handles (sizes 0-4) (1 set), Magill forceps in adult and pediatric sizes (1 each), disposable tubes in sizes 8.0, 7.0, 6.0, 5.0, 4.0, 3.0, 2.5, or equivalent (2 each), rigid adult stylettes (2 each), 10cc disposable syringe (2), and 5ml of water soluble lubricant (1).

e. There shall be an approved secondary airway device as prescribed by the agency's OMD. (1)

f. Assorted IV, IM, subcutaneous, and other drug and IV fluid administration delivery devices and supplies as specified by agency's OMD.

g. IV infusion pump. (1)

h. Defibrillator, cardioversion and external pacing capable. (1)

i. EKG monitor. (1)

j. Monitor electrodes, with adult and pediatric defibrillation pads. (2 each)

k. Adult and pediatric external pacing pads. (2 each)

l. Noninvasive blood pressure monitoring device capable of adult and pediatric use. (1)

m. Continuous end tidal CO₂ monitoring device. (1)

n. Pulse oximetry monitoring device. (1)

4. Critical care package air ambulance equipment requirements. Items listed are in addition to the air ambulance ALS package.

a. Invasive pressure monitoring equipment. (1)

b. Internal pacemaker and pulse generator immediately available. (1)

c. Ventilator as appropriate for mission.

d. IV infusion pumps. (2)

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

Article 5 EMS Personnel Requirements and Standard of Conduct

12VAC5-31-900 General requirements

Article 5 EMS Personnel Requirements and Standard of Conduct

EMS personnel shall meet and maintain compliance with the following general requirements:

1. Be a minimum of 16 years of age. (An EMS agency may have associated personnel who are less than 16 years of age. This person is not allowed to participate in any EMS response or other activity that may involve exposure to a communicable disease, hazardous chemical or other risk of serious injury.)

2. Be clean and neat in appearance;

3. Be proficient in reading, writing and speaking the English language in order to clearly communicate with a patient, family or bystander to determine a chief complaint, nature of illness, mechanism of injury and/or assess signs and symptoms.

4. Have no physical or mental impairment that would render him unable to perform all practical skills required for that level of training. Physical and mental performance skills include the ability of the individual to function and communicate independently to perform appropriate patient care, physical assessments and treatments without the need for an assistant.

5. Provide to the Office of EMS within 15 days, any change in contact information to include mailing address, electronic notification such as email, or telephone number.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-910 Criminal or enforcement history

A. General denial. Application for affiliation or certification of individuals convicted of certain crimes present an unreasonable risk to public health and safety. Thus, applications for affiliation or certification by individuals convicted of the following crimes will be denied in all cases:

1. Felonies involving sexual misconduct where the victim's failure to affirmatively consent is an element of the crime, such as forcible rape.

2. Felonies involving the sexual or physical abuse of children, the elderly or the infirm, such as sexual misconduct with a child, making or distributing child pornography or using a child in a sexual display, incest involving a child, or assault on an elderly or infirm person.

3. Any crime in which the victim is an out-of-hospital patient or a patient or resident of a health care facility including abuse of, neglect of, theft from, or financial exploitation of a person entrusted to the care or protection of the applicant.

4. Serious crimes of violence against persons such as assault or battery with a dangerous weapon, aggravated assault and battery, murder or attempted murder, manslaughter except involuntary manslaughter, kidnapping, robbery of any degree, or arson.

5. Has been subject to a permanent revocation of license or certification by another state EMS office or other recognized state or national health care provider licensing or certifying body.

B. Presumptive denial. Application for affiliation or current certification by individuals in the following categories will be denied except in extraordinary circumstances, and then will be granted only if the applicant or provider establishes by clear and convincing evidence that certification will not jeopardize public health and safety.

1. Application for affiliation or certification by individuals who have been convicted of any crime and who are currently incarcerated, on work release, on probation, or on parole.

2. Application for affiliation or certification by individuals convicted of crimes in the following categories unless at least five years have passed since the conviction or five years have passed since release from custodial confinement whichever occurs later:

a. Crimes involving controlled substances or synthetics, including unlawful possession or distribution or intent to distribute unlawfully Schedule I through V drugs as defined by the Virginia Drug Control Act (§ 54.1-3400 seq. of the Code of Virginia).

b. Serious crimes against property, such as grand larceny, burglary, embezzlement, or insurance fraud.

c. Any other crime involving sexual misconduct.

3. Is currently under any disciplinary or enforcement action from another state EMS office or other recognized state or national healthcare provider licensing or certifying body. Personnel subject to these disciplinary or enforcement actions may be eligible for affiliation or certification provided there have been no further disciplinary or enforcement actions for five years prior to application for certification in Virginia.

C. Permitted vehicle operations. Agencies are responsible for the monitoring of compliance with all driving criteria set forth in these regulations.

1. Personnel operating OEMS permitted vehicles shall posses a valid operator's or driver's license from his state of residence.

2. Personnel operating OEMS permitted vehicles shall not have been convicted on any charge as described in subsections A and B of this section.

3. Personnel who as the proximate result of having operated an OEMS permitted vehicle are (i) convicted of driving under the influence of alcohol or drugs or (ii) sentenced or assigned to any alcohol safety action program or any driver alcohol rehabilitation program pursuant to the Code of Virginia shall be prohibited from operating any OEMS permitted vehicle. Personnel or agencies shall be required to report these situations to OEMS.

4. Agencies shall develop and maintain policies that address driver eligibility, record review, and vehicle operation. Such policies must minimally address:

a. Driving education or training required for personnel to include information on the agency's policy content;

b. Safe operation of vehicles;

c. Agency driving record review procedures;

d. Requirement for immediate agency notification by personnel regarding any convictions, regardless of the state where an infraction occurred or changes to his operator's or driver's license. The immediate agency notification shall be defined as no more than 10 calendar days following the conviction date; and

e. Identification of internal mechanisms regarding agency level actions for driver penalties (i.e., probation or suspension of driving privileges).

D. All references to criminal acts or convictions under this section refer to substantially similar laws or regulations of any other state or the United States. Convictions include prior adult convictions, juvenile convictions and adjudications of delinquency based on an offense that would have been, at the time of conviction, a felony conviction if committed by an adult within or outside Virginia.

E. Agencies shall submit a report regarding items in this section to OEMS upon request.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012; Volume 35, Issue 2, eff. November 2, 2018.

12VAC5-31-920 [Reserved]. (Reserved)

12VAC5-31-930 State and federal law compliance

EMS personnel shall comply with all federal, state, and local laws applicable to their EMS operations.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-940 Drugs and substance abuse

A. EMS personnel may not be under the influence of any drugs or intoxicating substances that impairs their ability to provide patient care or operate a motor vehicle while on duty or when responding or assisting in the care of a patient.

B. The EMS agency shall have a drug and substance abuse policy which includes a process for testing for drugs or intoxicating substances.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-950 Disclosure of patient information

EMS personnel may not share or disclose medical information concerning the names, treatments, conditions or medical history of patients treated. This information must be maintained as confidential, except:

1. To provide a copy of the prehospital patient care report completed by the attendant-in-charge to the receiving facility for each patient treated or transported;

2. To provide a copy of the prehospital patient care report completed by the attendant-in-charge for each patient treated to the agency that responds and transports the patients. The prehospital patient care report copy shall be released to the transporting agency upon request after the patient transport to complete the transporting agency's records of all care provided to the patients transported;

3. To provide for the continuing medical care of the patient;

4. To the extent necessary and authorized by the patient or his representative in order to collect insurance payments due;

5. To provide continuing medical education of EMS personnel who provide the care or assistance when patient identifiers have been removed; or

6. To assist investigations conducted by the board, department or Office of EMS.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-960 Misrepresentation of qualifications

EMS personnel shall not misrepresent themselves as authorized to perform a level of care for which they are not currently qualified, licensed or certified. This requirement does not prohibit the performance of patient care by students currently enrolled in a training program when properly supervised as required by these regulations.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-970 Interference or obstruction of investigation

Any EMS agency, personnel, or entity who attempts knowingly or willfully to interfere or obstruct an Office of EMS investigation may be subject to enforcement action.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-980 False application for license, permit, certificate, endorsement or designation

EMS personnel may not obtain or aid another person in obtaining agency licensure, vehicle permitting, certification, endorsement or designation through fraud, deceit, forgery or deliberate misrepresentation or falsification of information.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-990 False statements or submissions

EMS personnel may not make false statements, misrepresentations, file false credentials or willfully conceal material information to the board, the department, or the Office of EMS regarding application for agency licensure, vehicle permitting, certification, endorsement or designation or in connection with an investigation conducted by the board, the department or the Office of EMS.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-1000 Falsification of materials

EMS personnel may not willfully alter or change the appearance or wording of any license, permit, certificate, endorsement, designation, prehospital patient care report, official agency documents, or any forms submitted to the Office of EMS.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-1010 Misappropriation or theft of drugs

EMS personnel may not possess, remove, use or administer any controlled substances, drug delivery devices or other regulated medical devices from any EMS agency, EMS vehicle, health care facility, academic institution or other location without proper authorization.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1020 Discrimination in provision of care

EMS personnel may not discriminate in the provision of emergency medical services based on race, gender, religion, age, national origin, medical condition or any other reason.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-1030 Sexual harassment

EMS personnel may not engage in sexual harassment. Sexual harassment includes making unwelcome sexual advances, requesting sexual favors, and engaging in other verbal or physical conduct of a sexual nature as a condition of:

1. The provision or denial of emergency medical care to a patient;

2. The provision or denial of employment or course advancement;

3. The provision or denial of promotions to a coworker;

4. For the purpose or effect of creating an intimidating, hostile, or offensive environment for the patient or student or unreasonably interfering with a patient's ability to recover; or

5. For the purpose or effect of creating an intimidating, hostile or offensive classroom or working environment or unreasonably interfering with a coworker's or student's ability to perform his work.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 16, eff. May 6, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1040 Operational medical director authorization to practice

A. EMS personnel as defined in § 54.1-3408 of the Code of Virginia may only provide emergency medical care while acting under the authority of the operational medical director for the EMS agency for which they are affiliated and within the scope of the EMS agency license. Privileges to practice must be on the agency's official stationery or indicated in the agency records which are signed and dated by the OMD.

B. Agencies shall establish a written policy that identifies the selection, response criteria, utilization, and approval process for (i) EMS personnel to carry and administer an epinephrine auto injector or medically accepted equivalent for emergency cases of anaphylactic shock, and (ii) the possession and administration of oxygen carried on personally owned vehicles (POV). The policy shall also include:

1. Annual approval and authorization by EMS agency and OMD.

2. Drug storage criteria to include:

a. Compliance with all applicable temperature requirements specified by the Virginia Board of Pharmacy.

b. Requirements that describe how the cylinder or device is to be secured in a manner to prevent any free movement within the occupant or storage compartment of the vehicle.

c. Evidence of approval by personal vehicle insurance carrier must be on file with EMS agency for all EMS personnel authorized to carry oxygen on personally owned vehicles.

3. The personal vehicle utilized to carry oxygen may be subject to inspection by the Office of EMS.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1050 Scope of practice

EMS personnel shall only perform those procedures, skills, or techniques for which he is currently licensed or certified, provided that he is acting in accordance with local medical treatment protocols and medical direction provided by the OMD of the licensed EMS agency with which he is affiliated and within the scope of the EMS agency licenses as authorized in the Emergency Medical Services Procedures and Medications Schedule as approved by the board.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1060 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1070 Extraordinary care outside of protocols

In the event of an immediate threat to loss of life or limb, medical control may authorize an EMS provider with specific training to provide care not authorized under existing protocol. The circumstances must be documented on the patient care report.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-1080 Inability to carry out medical control orders

In the following circumstances, EMS personnel may refuse to perform specific procedures or treatments, provided medical control is informed of the refusal and the refusal of care is documented on the prehospital patient care report:

1. If not adequately trained and proficient to perform the procedure;

2. If the procedure is not fully understood; or

3. If the procedure is judged not to be in the best interests of the patient.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-1090 Refusal of care

A decision not to treat or transport a patient shall be fully documented on the prehospital patient care report.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-1100 Consent or refusal

A. Whenever care is rendered without first obtaining consent, the circumstances shall be documented on the prehospital patient care report.

B. Refusal of care must be obtained and documented on the prehospital patient care report.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-1110 Transfer of patient care/patient abandonment

EMS personnel may not leave a patient in need of emergency medical care without first providing for a level of care capable of meeting the assessed and documented needs of the patient's condition is present and available or a refusal is obtained.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-1120 Provider disagreement over patient's needs

In the event that responding EMS personnel at the scene of a medical emergency have made differing assessments as to a patient's treatment needs or transport destination, medical control shall be contacted to resolve the conflict.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-1130 Attending of the patient during transports

During transportation, the patient shall be attended in the patient compartment of the vehicle by the required attendant-in-charge. Where additional attendants are required by these regulations, they must attend the patient in the patient compartment of the vehicle during transportation unless otherwise allowed.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-1140 Provision of patient care documentation

EMS personnel and EMS agencies shall provide the receiving medical facility or transporting EMS agency with a copy of the prehospital patient care report for each patient treated at the time of patient transfer. Should EMS personnel be unable to provide the full prehospital patient care report at the time of patient transfer, EMS personnel shall provide an abbreviated documented report with the critical EMS findings and actions at the time of patient transfer and the full prehospital patient care report shall be provided to the accepting facility within 12 hours.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 16, eff. May 6, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012; Volume 31, Issue 3, November 24, 2014.

12VAC5-31-1150 Emergency operation of EMS vehicle

EMS personnel are only authorized to operate an EMS vehicle under emergency conditions, as allowed by § 46.2-920 of the Code of Virginia:

1. When responding to medical emergencies for which they have been dispatched or have witnessed.

2. When transporting patients to a hospital or other medical clinic when the attendant-in-charge has determined that the patient's condition is unstable or life threatening.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-1160 Provision of care by mutual aid

EMS personnel who have not been specifically requested to respond to a call may assist a responding EMS agency at the scene of a medical emergency if the provider is licensed or certified to provide a level of care at the scene that is required to meet the assessed needs of the patient, and

1. A response obligation to locality or a mutual aid agreement exists between the provider's EMS agency and the responding EMS agency, or

2. Medical control shall be contacted to obtain approval to provide patient care as the AIC. If contact with medical control is not possible or would unduly delay the provision of care, then the EMS provider may proceed with the indicated treatment with approval of the responding EMS agency's personnel on the scene. In such event, the circumstances of the incident must be documented on the prehospital patient care report.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-1165 EMS agency mutual aid response

An EMS agency providing resources, certified personnel, permitted vehicles, or equipment as a result of an Emergency Management Assistance Compact (EMAC), Federal Emergency Management Agency (FEMA), or any other out-of-state mutual aid request shall notify OEMS upon commitment of requested resources. Notification by direct verbal communication shall be made to the local OEMS program representative.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1170 Provision of care by students

A student enrolled in an approved EMS certification training program may perform the clinical skills and functions of EMS personnel who are certified at the level of the course of instruction while participating in clinical and field internship training as provided for in these regulations when:

1. The student is caring for patients in the affiliated hospitals or other facilities approved by the training program's PCD, provided that the related didactic subject matter and practical skills laboratory have been completed and the students are under the direct supervision of a preceptor who is a physician, physician assistant, nurse practitioner, registered nurse or an EMS provider certified at or above the level of the training program. The affiliated hospital or facility must approve preceptors.

2. The student is caring for patients during a required course internship program with an EMS agency approved by the training program's PCD and EMS agency's OMD, provided that the related didactic subject matter and practical skills laboratory have been completed and the student is under direct supervision of and accompanied by an EMS provider certified at or above the level of the training program, or under the direct supervision of a licensed physician.

3. Nothing in subdivision 1 or 2 of this section removes the obligation of the supervising hospital, facility or licensed EMS agency for ultimate responsibility for provision of appropriate patient care during clinical or internship training.

4. Nothing in subdivision 1 or 2 of this section may be construed to authorize a noncertified or unlicensed individual to provide care outside of the approved supervised settings of the training program in which they are enrolled.

5. Nothing in subdivision 1 or 2 of this section may be construed to authorize a noncertified or unlicensed individual to provide care or to operate an emergency medical services vehicle in a county or municipality that has enacted an ordinance pursuant to § 32.1-111.14 A 8 of the Code of Virginia making it unlawful to do so.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-1180 Adequate response staffing

An EMS agency shall provide for an adequate number of trained or certified EMS personnel to perform all essential tasks necessary for provision of timely and appropriate patient care on all calls to which the EMS agency responds.

1. A responding EMS vehicle shall be staffed with the appropriately trained and qualified personnel to fulfill the staffing requirements for its vehicle classification. An operator may respond alone with an EMS vehicle to a medical emergency if the required EMS providers is known to be responding to the scene.

2. An EMS agency shall respond with a sufficient number of agency or mutual aid agency personnel to lift and move all patients who are in need of treatment or transport.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-1190 Attendant-in-charge authorization

An attendant-in-charge shall be authorized by the EMS agency's OMD to use all skills and equipment required for his level of certification and the type of transport to be performed.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-1200 Minimum age of EMS vehicle personnel

A. EMS personnel serving in a required staffing position on an EMS vehicle shall be at a minimum 18 years of age.

B. An EMS agency may allow assistants or observers in addition to the required personnel. An assistant or observer must be at a minimum 16 years of age.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-1210 Nontransport response vehicle staffing

At a minimum, one person may satisfy both of the following requirements:

1. An operator shall at a minimum possess a valid motor vehicle operator's permit issued by Virginia or another state and have successfully completed an approved emergency vehicle operator's course (EVOC) training course or an equivalent.

2. Attendant-in-charge shall be currently certified as an EMS first responder, emergency medical responder, or emergency medical technician or an equivalent approved by the Office of EMS.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1220 Transfer of ALS package

Advanced life support equipment may be transferred from one EMS vehicle to another EMS vehicle not otherwise equipped to provide the needed level of ALS. When this equipment is transferred, the EMS vehicle shall have required EMS personnel in compliance with these regulations.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-1230 Ground ambulance staffing requirements

A ground ambulance transport requires a minimum of two persons:

1. An operator shall at a minimum possess a valid motor vehicle operator's permit issued by Virginia or another state and have successfully completed an approved Emergency Vehicle Operator's Course (EVOC) training course or an equivalent.

2. An attendant-in-charge who must meet the requirements listed for the type of transport to be performed.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-1240 Basic life support vehicle transport

During a basic life support transport, the attendant-in-charge must be certified as an emergency medical technician or an equivalent approved by the Office of EMS.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-1250 Advanced life support vehicle transport

Advanced life support transport requirements:

1. A ground ambulance equipped with an ALS equipment package. An ALS equipment package may be transferred to a ground ambulance not otherwise equipped to provide the needed level of ALS patient care from another appropriately equipped EMS vehicle. This transfer must include all items required for the type of ALS equipment package that the attendant-in-charge is authorized to use.

2. The attendant-in-charge must be certified as an advanced life support level provider or an equivalent approved by the Office of EMS.

3. An attendant must be certified as an emergency medical technician or an equivalent approved by the Office of EMS in addition to the attendant-in-charge. The attendant must not serve as the attendant-in-charge. An operator may serve as the attendant if certified as an emergency medical technician or an equivalent approved by the Office of EMS.

4. An ALS provider may provide care in the event that the required EMS personnel do not respond to a call to fully staff the ambulance that has responded to the scene. The extenuating circumstances of the call must be documented in writing. Based on extenuating circumstances and documentation, the EMS agency or the EMS provider may be subject to enforcement action.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1260 Supplemented transport requirements

A. Supplemented transports require the following:

1. An ambulance equipped with an ALS intermediate/paramedic equipment package;

2. A determination by the sending physician that the patient's medically necessary care exceeds the scope of practice of available personnel certified at an advanced life support level or an equivalent approved by the Office of EMS; or

3. A determination by the sending physician that the specific equipment needed to care for the patient exceeds that required for a ground ambulance equipped with an ALS Advanced EMT/intermediate/paramedic equipment package.

B. An attendant-in-charge who must be a physician, registered nurse or physician assistant who is trained and experienced in the care and the equipment needed for the patient being transported.

C. An attendant who must be certified as an emergency medical technician or an equivalent approved by the Office of EMS in addition to the attendant-in-charge. The attendant must be a third person who is not the Operator.

D. An EMS agency requested to perform a supplemented transport, is responsible for the following:

1. Obtaining a written statement from the sending physician detailing the specific nature of the patient's medical condition and the medical equipment necessary for the transport. The written statement may be in the form of transport orders documented in the patient's medical record.

2. Verifying that the individual acting as attendant-in-charge for the transport is experienced in the patient care required and the operation of all equipment to be used for the patient to be transported.

An EMS agency requested to perform a supplemented transport shall refuse to perform the transport if compliance with the requirements of this section cannot be satisfied. Refusal to provide the transport must be documented by the EMS agency.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1270 Neonatal transport requirements

A. If a ground ambulance is utilized to perform an interfacility neonatal transport, the vehicle must be equipped with the additional items listed in 12VAC5-31-860 C, D 3, and D 5 and staffed in compliance with this section.

B. A minimum of three persons is required:

1. An operator who at a minimum possesses a valid motor vehicle operator's permit issued by Virginia or another state, and who has successfully completed an approved emergency vehicle operator's course (EVOC) training course or an equivalent approved by the Office of EMS.

2. An attendant-in-charge who must be one of the following:

a. Physician;

b. Registered nurse or physician assistant, licensed for a minimum of two years, with specialized neonatal transport training; or

c. Other health care personnel with equivalent training or experience as approved by the Office of EMS.

3. An attendant. The operator, attendant-in-charge or attendant must be certified as an emergency medical technician or an equivalent approved by the Office of EMS.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1280 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1290 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1300 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

Article 1 Certification Levels

12VAC5-31-1305 EMS First Responder (FR)

Article 1 Certification Levels

This section will expire on October 10, 2016.

The certification is issued for a period of four years from the end of the month of issuance.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012; Errata 29:2 VA.R. 335-336 September 24, 2012.

12VAC5-31-1307 Emergency Medical Responder (EMR)

The certification is issued for a period of four years from the end of the month of issuance.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1310 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1315 Emergency Medical Technician (EMT)

The certification is issued for a period of four years from the end of the month of issuance.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1320 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1325 Emergency Medical Technician Enhanced (EMT-E)

This section will expire on April 10, 2016.

A. The certification is issued for a period of three years from the end of the month of issuance.

B. An EMS provider who possesses a valid EMT-E certification is simultaneously issued an EMT certification for an additional two years after his EMT-E expiration.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012; Errata 29:2 VA.R. 335-336 September 24, 2012.

12VAC5-31-1330 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1335 Intermediate

A. The certification is issued for a period of three years from the end of the month of issuance.

B. An EMS provider who possesses a valid Intermediate certification is simultaneously issued an EMT certification for an additional two years after his Intermediate expiration.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1337 Advanced Emergency Medical Technician (AEMT).

A. The certification is issued for a period of three years from the end of the month of issuance,

B. An EMS provider who possesses a valid AEMT certification is simultaneously issued an EMT certification for an additional two years after his Advanced AEMT expiration.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012; Errata 29:2 VA.R. 335-336 September 24, 2012.

12VAC5-31-1340 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1345 Paramedic

A. The certification is issued for a period of three years from the end of the month of issuance.

B. An EMS provider who possesses a valid Paramedic certification is simultaneously issued an EMT certification for an additional two years after his Paramedic expiration.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1350 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1355 Emergency Medical Technician-Instructor

This section will expire on October 10, 2016.

A. The certification is valid for a period of two years from the end of the month of issuance.

B. An EMS provider who possesses a valid instructor certification is simultaneously issued an EMT certification valid for an additional two years after his instructor expiration.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012; Errata 29:2 VA.R. 335-336 September 24, 2012.

12VAC5-31-1360 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1365 Advanced Life Support Coordinator

The certification is valid for a period of two years from the end of the month of issuance.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1370 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1375 EMS Education Coordinator

The certification is valid for a period of three years from the end of the month of issuance.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1380 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

Article 2 Certification Process and Practice

12VAC5-31-1385 Certifcation periods

Article 2 Certification Process and Practice

An EMS certification is valid for the prescribed period as defined in Article 1 of this part for each level of certification unless suspended or revoked by the commissioner.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1387 Virginia EMS certification is required to practice

In order to function as an EMS provider in the Commonwealth of Virginia, providers must hold a valid certification as issued by the commissioner and as defined in 12VAC5-31-1040.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1389 Initial course certification

A. Candidates must successfully complete an approved Virginia certification course to be eligible for the certification examination.

B. Candidates must then successfully complete the certification examination to receive Virginia certification at the level for which the course is approved.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1390 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 28, Issue 1, eff. October 10, 2012.

12VAC5-31-1391 Certification through reciprocity

A person holding valid EMS certification from another state or a recognized EMS certifying body with which Virginia has a formal written agreement of reciprocity or possessing a National Registry certification at the EMR, EMT, Advanced EMT, Intermediate 99 or Paramedic level shall apply to the commissioner for reciprocity upon demonstration of Virginia residency, Virginia EMS agency affiliation, or a recognized need for Virginia EMS certification and demonstrate as defined by the Office of EMS eligibility for certification at the level sought in Virginia from the state in which the same level training program was held.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1393 Certification through legal recognition

A person holding valid EMS certification from another state or a recognized EMS certifying body who does not meet the criteria in 12VAC5-31-1391 shall apply to the commissioner for legal recognition upon demonstration of Virginia residency, Virginia EMS agency affiliation, or a recognized need for Virginia EMS certification. Legal recognition may be issued for a period of one year or the duration of his current certification, whichever is shorter. Legal recognition is not available for any Virginia certification level if the Board of Health has determined that no equivalent exists at the level requested.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1395 EMT certification challenge

A practical nurse, registered nurse to include those recognized through the Nurse Licensure Compact (§ 54.1-3030 et seq. of the Code of Virginia), physician assistant, dentist, or chiropractor who holds a current license to practice in Virginia; military corpsman with current credentials; and third or fourth year medical students shall apply to the commissioner for authorization to challenge at the EMT level. Upon completing the requirements for the EMT recertification and receiving notification of testing eligibility the candidate must complete the written and practical examination. Examination waivers are not allowed.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1400 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1401 General recertification requirements

A. An EMS provider requesting recertification must complete the continuing education hour requirements, as identified in 12VAC5-31-1403, for the level at which the EMS provider is requesting to be recertified. The Office of EMS must receive documentation of the EMS provider's completion of continuing education within the issued certification period for the provider to maintain a current certification.

B. An EMS provider under legal recognition pursuant to 12VAC5-31-1393 must recertify by passing a Virginia written and practical EMS certification examination.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012; amended, Virginia Register Volume 30, Issue 10, eff. March 1, 2014.

12VAC5-31-1403 EMS provider recertification required

A. Recertification of EMS credentials requires each individual to complete continuing education requirements as approved by the Board of Health and fulfill the recertification process before the expiration date of an applicable certification or reentry period.

B. The Board of Health will determine the continuing education hour and topic category requirements for each certification level.

C. Evidence of completion of the continuing education requirements must be received by the Office of EMS prior to the certification expiration.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1405 Documentation of continuing education (CE)

A. Continuing education credit is only awarded to courses announced to the Office of EMS in a format as approved by the Office of EMS prior to the course being conducted and other programs approved by the Office of EMS for award of CE.

B. Award of credit for attendance in a CE program shall be submitted in a format approved by the Office of EMS.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1407 Recertifcation through reentry

A. Individuals whose certification has expired may regain certification through completion of the reentry program within two years of the specific certification's expiration date. To reenter the person must fulfill the requirements as applicable in this chapter including all required testing within the two-year reentry period.

B. Individuals failing to complete the reentry process by the end of the two-year period following certification expiration will be required to complete an initial training program for the level lost.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

Article 3 Educational Programs and Management

12VAC5-31-1409 Course curriculum

Article 3 Educational Programs and Management

A. Course coordinators (EMT instructor, ALS coordinator, or EMS education coordinator) shall utilize curricula or educational standards authorized and approved by the Office of EMS when conducting EMS education programs.

B. CE topics must be submitted for review and approval in a format as approved by the Office of EMS.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1410 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1411 BLS certification programs

BLS certification programs authorized for issuance of certification in Virginia are:

1. EMS First Responder.

2. EMS First Responder Bridge to EMT.

3. Emergency Medical Responder (EMR).

4. Emergency Medical Responder Bridge to EMT.

5. Emergency Medical Technician (EMT).

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1413 Advanced life support certification programs

ALS certification programs authorized for issuance of certification in Virginia are:

1. EMT-Enhanced.

2. EMT -Enhanced Bridge to Intermediate.

3. Advanced EMT.

4. Advanced EMT Bridge to Intermediate.

5. Intermediate.

6. Intermediate Bridge to Paramedic.

7. Paramedic.

8. RN Bridge to Paramedic.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1415 Nationally recognized continuing education programs

A. In order for a provider to receive continuing education in Virginia for an auxillary program, the national parent organization must be recognized by the Board of Health.

B. The instructor approved by the national parent organization referenced in subsection A of this section may award Category 1 continuing education credit for providers successfully completing an approved course. The instructor is not required to be an EMT instructor, ALS coordinator, or an EMS education coordinator in order to submit for course approval.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1417 Approved courses in cardio-pulmonary resuscitation

A. Recognized programs for certification in cardiopulmonary resuscitation (CPR) for the purposes of testing for all certification levels are based upon programs approved by the Board of Health.

B. Completion of an approved course that tests the following skills is required:

1. One and two rescuer CPR - adult, child, infant resuscitation.

2. Complete airway obstruction - unconscious victim - adult, child, infant.

3. Complete airway obstruction - conscious victim - adult, child, infant.

4. Automated external defibrillation.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1419 Continuing education programs

The programs must utilize the approved format for the corresponding level of certification as designed by the Office of EMS:

1. Category 1 (required) are topic areas that are required as part of the recertification criteria.

2. Category 2 (approved) are topic areas that support EMS activities.

3. Category 3 are topic areas that are delivered through a multimedia format as approved by the Board of Health.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1420 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1421 Teaching materials and approved texts

A. EMT instructor, ALS coordinator, or an EMS education coordinator shall use teaching materials and textbooks that reflect current EMS practices.

B. All textbooks and primary teaching materials utilized in a program shall be reviewed and receive written approval prior to the start of the program by the physician course director (PCD) or OMD and shall be maintained with other course records in accordance with the Virginia Public Records Act (Chapter 7 (§ 42.1-76 et seq.) of Title 42.1 of the Code of Virginia).

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1423 Course announcement requirements

A. BLS certification courses and continuing education programs that award Category 1 (required) continuing education credits shall be announced by an EMT instructor or EMS education coordinator. An EMT instructor or EMS education coordinator shall be present in the classroom at all times except:

1. In courses offered by the Office of EMS accredited programs, or

2. In BLS continuing education programs.

B. ALS certification courses and continuing education programs that award Category 1 (required) continuing education credits shall be announced by an ALS coordinator or EMS education coordinator.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1425 EMT instructor, ALS coordinator, or EMS education coordinator responsibilities as employee or contractor

A. An EMT instructor, ALS coordinator, or EMS education coordinator conducting training programs as an employee or contractor for any other person as defined in § 1-230 of the Code of Virginia, whether or not for profit, shall retain responsibility for compliance with the Office of EMS regulations.

B. Any other person as defined in § 1-230 of the Code of Virginia who operates an organization for the purpose of providing an EMS training program that employs or contracts with an EMT instructor, ALS coordinator, or EMS education coordinator to conduct a training program may not vary from or direct the EMT instructor, ALS coordinator, or EMS education coordinator to vary from compliance with Office of EMS regulations.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1427 Course approval request submission

A. An EMT instructor, ALS coordinator, or EMS education coordinator shall submit a course approval request in a format approved by the Board of Health prior to the beginning date of a certification or continuing education course.

1. Any approved course requesting funding through the EMS training fund requires that the course approval request and funding contract must be post marked or received, and date and time stamped, by the Office of EMS no less than 45 days prior to the begin date for the course.

2. Courses shall not start prior to receiving course number and topic or topics from the Office of EMS.

B. The EMT instructor, ALS coordinator, or EMS education coordinator shall use only those topic numbers assigned for the course as approved by the Office of EMS.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1429 Course approval request changes

The course coordinator shall immediately notify the Office of EMS in writing of any changes in the information submitted on the Course Approval Request form.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1430 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1431 Student course enrollment

For courses leading to certification at a new or higher level, the EMT instructor, ALS coordinator, or EMS education coordinator shall have each student complete a "Virginia EMS Training Program Enrollment" form at the first meeting of the course.

1. These forms must be reviewed by the EMT instructor, ALS coordinator, or EMS education coordinator and submitted to the Office of EMS no later than five business days following the first meeting of the course.

2. Any student who starts the program at a later date shall complete an enrollment form the first date of attendance providing 15% or more of the entire course has not been completed.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1433 Instructor participation records

The EMT instructor, ALS coordinator, or EMS education coordinator shall maintain the following information: instructor/provider level, subject taught, and participation of each certified EMT instructor, ALS course coordinator, EMS education coordinator, or other individual who instructs in the program.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1435 Student records for certification courses

A. The EMT instructor, ALS coordinator, or EMS education coordinator shall maintain records of class dates, topics instructed, attendance and performance for all students attending a certification course.

B. Student records shall be maintained in accordance with the Virginia Public Records Act (Chapter 7 (§ 42.1-76 et seq.) of Title 42.1 of the Code of Virginia) from the end date of the program and shall include but not be limited to:

1. Signed student acknowledgment forms collected upon completion of review of the appropriate BLS or ALS enrollment requirements.

2. Student signed class rosters.

3. Scores on all course quizzes, exams, and other didactic knowledge or practical skill evaluations.

4. Skill proficiency records in a format as approved by the Office of EMS:

a. For BLS programs, BLS individual age and clinical and skill performance verification information in a format as approved by the Office of EMS.

b. For ALS coordinator or EMS education coordinator programs, on forms or documents as approved by the ALS coordinator, EMS education coordinator, or an accredited program.

5. All hospital or field internship activities including dates, locations, competencies performed, student evaluations, preceptor name and certification level as applicable.

6. All corrective or disciplinary actions taken during the training program to include dates, findings supporting the need for corrective or disciplinary action, and all applicable details of steps taken to determine the degree and nature of the actions taken.

7. Copy of the course student disposition report (CSDR).

8. All other records requested to be maintained by the PCD or OMD for the program.

9. Any other records or reports as required by the Office of EMS.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1437 Continuing education record submission

The course coordinator shall submit the CE records in a format approved by the Office of EMS within 15 days of the student's attendance.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1439 Verification of student course completion

Verification of student eligibility on the Course Student Disposition Record by the EMT instructor, ALS coordinator, or EMS education coordinator for certification testing requires that each student successfully complete a certification program that meets the competency and performance requirements contained within the applicable course requirements and all other guidelines and procedures for the course and state certification testing eligibility.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1440 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1441 Communications with PCD or OMD

A. The EMT instructor, ALS coordinator, or EMS education coordinator shall inform the PCD or OMD of the progress of the training program to include:

1. Any program schedule changes.

2. Individual student performances.

3. Any student or instructor complaints.

4. The general progress of program activities.

B. The EMT instructor, ALS coordinator, or EMS education coordinator will assist the PCD or OMD with fulfillment of their course duties as required by Office of EMS regulations.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1443 Alternative course presentation format

EMS certification courses utilizing an approved alternative course presentation format using two-way video interactive technology shall comply with the following:

1. Use electronic media as real time two-way audio and video transmissions.

2. The EMT instructor, ALS coordinator, or EMS education coordinator must indicate in writing the desire to use such media which shall accompany the Course Approval Request form.

3. Any other requirements established by, but not limited to, the Office of EMS and, if applicable, the Virginia Community College System (VCCS) and the Virginia Department of Education.

4. For sites using one-way video and two-way audio, a proctor who is certified at or above the level of the program shall be present at each remote site during the entire broadcast for all didactic portions of the program.

5. Any lab activities at the remote site shall have direct on-site supervision by a course faculty member at or above the level of instruction. If the faculty member acts as the remote site proctor, he assumes the responsibility of the class roster.

6. In cases where the remote site proctor is absent or when the remote site electronics are not fully operational (transmit and receive audio or video) the students do not receive credit for attending and the session shall be rescheduled.

7. All course tests for the program whether at the origin or remote site must comply with subdivision 4 of this section.

8. The course coordinator must maintain records of student participation in the approved alternative presentation format and submit continuing education records for each involved student for programs used for continuing education purposes.

9. Noncompliance with these regulations shall result in removal of Office of EMS approval and students shall lose eligibility for certification testing at the level of program certification.

10. The Guidelines for Videobroadcasting of EMS Educational Programs document must be signed by the EMT instructor, ALS coordinator, or EMS education coordinator and PCD or OMD and accompany any request for electronic transmission of a program with the Course Approval Request form.

11. Letter of agreement from the remote site or sites confirming and agreeing to the guidelines.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1445 Course scheduling

Courses schedules shall reflect the minimum hours for the course of instruction of all required lessons of the program's curriculum prior to the course end date as approved by the Office of EMS.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1447 Maximum BLS or ALS course enrollment

A. Initial and bridge certification course size shall be limited to a maximum of 30 enrolled students.

1. Additional students seeking continuing education credit may be admitted as reasonably allowed by facility size and instructional staff availability.

2. The group size for practical or lab skill sessions shall not exceed six students per instructor aide (6:1 ratio).

B. Office of EMS accredited institutions or organizations may exceed the maximum of 30 enrolled students, with demonstrated resources to meet class size. The group size for practical or lab skill sessions shall not exceed six students per instructor aide (6:1 ratio).

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1449 Lesson instructors

A. In addition to the lead instructor for each lesson, arrangements must be made to provide for instructor aides to assist in all practical skill sessions. Instructor aides shall be providers certified at or above the level of instruction.

B. Course coordinators who are certified EMTs may be used for instruction of basic skill stations in advanced life support programs. Basic skills are those procedures not requiring invasive activities or use of ALS equipment.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1450 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1451 Course monitoring

All programs and courses approved for issuance of certification or award of continuing education shall allow unannounced monitoring by the Office of EMS. Failure to comply with such course monitoring may result in the following disciplinary actions to include, but not be limited to:

1. Revocation of the training program's course approval.

2. Suspension or revocation of the training program's authority to award continuing education credits.

3. Revocation of the enrolled student's eligibility for certification testing.

4. Suspension or revocation of the EMS instructor , ALS-coordinator, or EMS educational coordinator.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1453 EMT instructor, ALS coordinator, and EMS educational coordinator responsibilities for initial student testing

A. An EMT instructor or EMS education coordinator for BLS programs shall ensure the following for documentation of eligibility for certification testing:

1. Submit a completed Course Student Disposition Report (CSDR) in a manner as prescribed by the Office of EMS.

2. Maintain with the course materials the completed individual parental permission form for students between 16 and 18 years of age on the beginning date of the course.

3. Maintain with the course materials the original copy of the completed and signed Basic Life Support Individual Age, Clinical and Skill Performance Verification Record.

B. An ALS coordinator or EMS education coordinator coordinating ALS programs shall submit the CSDR for certification testing eligibility.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

Article 4 Certification Testing

12VAC5-31-1454 Admission to certification test.

Article 4 Certification Testing

A. The person desiring to take the certification examination must present the following:

1. The Virginia certification eligibility letter.

2. Current government issued photo identification.

3. If a retest, the latest testing results.

B. The person desiring to take the certification examination must be registered for the test site.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1455 Certification testing requirements

A. An Office of EMS written and practical examination process is required by the following:

1. Any candidate who completes an initial program at the following levels:

a. First Responder/EMR.

b. Emergency Medical Technician.

c. Emergency Medical Technician-Enhanced.

d. Advanced EMT.

e. Intermediate provided National Registry no longer tests at this level.

2. Any candidate who is challenging the certification level.

3. Any certified EMS provider who received his current certification through legal recognition.

4. Any candidate who is in reentry for First Responder or Emergency Medical Technician.

B. An Office of EMS written examination only is required for the following:

1. Any provider who recertifies prior to his certification expiration except those who received his current certification through legal recognition.

2. Any candidate who is in reentry for EMT-Enhanced, Advanced EMT, Intermediate and Paramedic.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1457 General description of certification examination

A. Office of EMS certification examinations are required by all providers unless otherwise described in these regulations.

B. Primary certification testing is the first attempt at the certification examination process.

1. This process includes both the written and practical examination for providers seeking a new or higher level of certification.

2. Primary testing must begin within 180 days of the course end date.

C. Primary retest requires the candidate to retest that portion of the primary test failed within 90 days of the primary test attempt.

D. Secondary certification testing (written and practical) occurs when a candidate fails the primary attempt and either fails the primary retest or does not retest within 90 days of the primary examination attempt. Secondary certification testing requires the candidate to submit as described in these regulations CE that satisfies the recertification requirements for the level of EMS certification sought.

E. Secondary retest requires the candidate to retest that portion of the secondary test failed within 90 days of the secondary test attempt.

F. Successful completion of the certification examination process must be completed within 365 days of the primary test attempt.

G. The certification examination process requires that certification testing be conducted and proctored in a manner approved by the Office of EMS.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1459 Certification eligibility

Certification eligibility will be demonstrated by the possession of a valid eligibility letter from the Office of EMS by the candidate.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1460 (Repealed.)

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1461 Prohibition of oral examinations

A certification candidate may not use another person or any electronic or mechanical means to translate written certification examination material into an audible, tactile, or visual format.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1463 Candidates requirements for state recertification

A. This section shall apply to individuals requesting state recertification who hold current certification at or below the level requested to be recertified (excluding those who gained their current certification through legal recognition).

B. Students requesting recertification must demonstrate eligibility as evidenced by completion of the continuing education requirements for the corresponding recertification program for the level to be recertified. Evidence of completion for the continuing education requirements shall be received by the Office of EMS in an approved method prior to certification expiration for the provider to be classified in current provider status.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1465 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012; repealed, Virginia Register Volume 30, Issue 10, eff. March 1, 2014.

12VAC5-31-1467 Basic and advanced life support written examinations

A. All state written examinations shall be conducted by the Office of EMS.

B. The Office of EMS standard for successful completion is defined as a minimum score of:

1. 70% on all basic life support certification examinations.

2. 80% on all EMT instructor and EMS education coordinator certification examinations.

3. 85% on all EMT instructor and EMS education coordinator pretest examinations.

4. 80% on all advanced life support certification examinations.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1469 Basic and advanced life support practical certification examinations

A. Practical examinations shall be conducted by the Office of EMS or as approved for accredited training programs.

B. Candidates taking a practical examination conducted by the Office of EMS shall demonstrate proficiency on all practical stations required for the program level being tested. Grades of unsatisfactory will constitute failure of that station, requiring a retest.

C. Candidates failing any practical station examination conducted by the Office of EMS will have an opportunity to retest the station or stations failed.

D. If a primary retest is failed, the candidate examination conducted by the Office of EMS must complete the secondary retest requirements.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1470 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1471 Examination retest

A. Candidates failing to achieve a minimum passing score on any state administered written or practical examinations must retest within 90 days from the original exam date.

B. BLS and EMT Enhanced candidates failing one or more stations of the practical but passing the written examination are not required to repeat a successful written examination of a testing series. Likewise, a candidate failing the written examination would not be required to repeat a successful practical examination of a testing series.

C. If any retest is failed or a retest is not taken within the allowed 90-day retest period, the candidate will be considered to have failed the initial testing series and must complete secondary eligibility before secondary certification testing may be attempted.

D. Secondary certification testing eligibility requires:

1. Satisfaction of all requirements as set forth in the minimum continuing education requirements for the corresponding recertification CE program for the level being tested.

a. This training may not include any course or program completed before the initial series of testing.

b. This training may include those CE hours completed after the initial certification examination has been attempted.

c. This training must be submitted on CE cards or a format as approved by the Office of EMS.

2. Receipt of written notification from the Office of EMS of eligibility for secondary certification testing.

E. Upon notification of eligibility to test from the Office of EMS, a candidate who has previously failed a written or practical retest will be allowed one additional series of testing.

1. Candidates attempting a second series of testing are required to successfully complete both the written and practical examinations regardless of the results of the previous testing attempts.

2. This requirement for successful completion of both the written and practical examinations will apply equally to initial, recertification, and reentry candidates who have failed a previous series of testing.

3. All appropriate sections of these regulations will apply to the second series of testing.

F. Failure of any retest during the second series of testing will require the candidate to complete an entire initial basic training program or applicable bridge course before any additional testing may be attempted at this certification level.

G. The requirements of this section including initial and secondary certification testing series must be completed within 365 days from the date of the initial certification test attempt (i.e., first test date) or prior to the enrollment expiration date for students attending an OEMS accredited program. Failure to complete this process within this prescribed period will require the candidate to repeat an entire initial basic training program or applicable bridge course before any additional testing may be attempted at this certification level.

H. Future testing of candidates required to complete an entire initial basic training program under subsections F or G of this section will be processed in the same manner as any candidate completing a similar course for the first time.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1473 Candidate evidence of eligibility for retesting

Candidates requesting to retest a failed written or practical exam or exams must demonstrate eligibility as evidenced by presentation of the letter of retest eligibility from the Office of EMS and the latest test results.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1475 Candidate evidence of eligibility for secondary testing

Candidates requesting testing a second series of exams after failure of an initial testing series must demonstrate eligibility as evidenced by valid secondary eligibility notice from the Office of EMS.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1477 Examination security and review

A. All Virginia examinations are the property of the Office of EMS. Individuals taking an examination may not copy or make recordings or reproduce in any other manner any material from the examination. Failure to return the examination will subject the individual to disqualification for certification.

B. Giving or obtaining information or aid prior to, during, or following any exam as evidenced by direct observation of the state examination administrator or administrators or subsequent analysis of examination results or engaging in other prohibited acts, may be sufficient cause to terminate candidate participation, to invalidate the results of a candidate's examination, to take enforcement action against other involved persons, or to take other appropriate action even if there is no evidence of improper conduct by the candidate. In these cases, the Office of EMS reserves the right to delay processing of examination results until a thorough and complete investigation may be conducted.

1. Unauthorized giving or obtaining information will include but not be limited to:

a. Giving unauthorized access to secure test questions.

b. Copying or reproducing all or any portion of any secure test booklet.

c. Divulging the contents of any portion of a secure test.

d. Altering candidate's responses in any way.

e. Making available any answer keys.

f. Providing a false certification on any test security form required by the Office of EMS.

g. Retaining a copy of secure test questions.

h. Falsely taking any examination, or part thereof, on behalf of another individual.

i. Participating in, directing, aiding, or assisting in any of the acts prohibited by this section.

2. For the purposes of this section the term "secure test" means any item, question, or test that has not been made publicly available by the Office of EMS.

3. Nothing in this section may be construed to prohibit or restrict the reasonable and necessary actions of the Office of EMS in test development or selection, test form construction, standard setting, test scoring and reporting, or any other related activities that in the judgment of the Office of EMS are necessary and appropriate.

C. Under no circumstances will written examinations and practical scenarios be provided to EMT instructor, ALS coordinator, EMS education coordinator, PCD or OMD, or candidates for their review at any time.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1480 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1490 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1500 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

Article 5 BLS Programs

12VAC5-31-1501 BLS certification course attendance

Article 5 BLS Programs

A. Students must complete a minimum of 85% of the didactic and lab aspects of the course.

B. Students must complete all healthcare facility competency and field internship requirements for the program.

C. Students must successfully demonstrate competency to perform all required skills as specified by the Office of EMS for the level of the training program attended. Use of training manikin practice may not substitute for performance of skills involving actual patients in a clinical setting except as allowed by the Office of EMS.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1503 BLS course student requirements

The enrolled student, certification candidate, or EMS provider must comply with the following:

1. Be proficient in reading, writing and speaking the English language in order to clearly communicate with a patient, family, or bystander to determine a chief complaint, nature of illness or, mechanism of injury; assess signs and symptoms; and interpret protocols.

2. Be a minimum of 16 years of age at the beginning date of the certification program. If less than 18 years of age, the student must provide the EMT instructor or the EMS educational coordinator with a completed parental permission form as approved by the Office of EMS with the signature of a parent or guardian supporting enrollment in the course.

3. Have no physical or mental impairment that would render the student or provider unable to perform all practical skills required for that level of certification including the ability to function and communicate independently and perform patient care, physical assessments, and treatments.

4. Hold current certification in an approved course in cardio-pulmonary resuscitation (CPR) at the beginning date of the certification program. This certification must also be current at the time of state testing.

5. If in a bridge certification program, the student must hold current Virginia certification at the EMS First Responder level through completion of the certification examination process.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1505 EMS First Responder certification program

The EMS First Responder curriculum will be the current version of the Virginia Standard Curriculum or Virginia education standards for the EMS First Responder as approved by the Office of EMS and will consist of a minimum number of hours of didactic training.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1507 First Responder bridge to EMT

The Virginia EMS First Responder Bridge curriculum will be based upon the National Standard Curriculum for the EMT and the bridge program curriculum approved by the Office of EMS.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1509 EMS First Responder bridge length

The Virginia EMS First Responder Bridge will consist of a minimum number of hours of didactic training and competency.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1510 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1511 First Responder bridge to EMT certification examinations

Candidates completing the Virginia EMS First Responder Bridge program must complete the current EMT written and practical examinations administered by the Office of EMS.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1513 Emergency Medical Technician (EMT) certification

The EMT curriculum will be based upon the current version of the National Standard Curriculum for the EMT or Virginia education standards and any additions, deletions, or other modifications as approved by the Office of EMS and will consist of a minimum number of hours of didactic training and competency.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1515 Emergency Medical Technician (EMT) certification examination

Candidates completing the EMT training program must successfully complete the Office of EMS approved EMT written and practical examinations.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1520 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

Article 6 ALS Programs

12VAC5-31-1521 ALS course student requirements

Article 6 ALS Programs

An enrolled student in an ALS certification program shall comply with the following:

1. Be proficient in reading, writing and speaking the English language in order to clearly communicate with a patient, family or bystander to determine a chief complaint, nature of illness, mechanism of injury, to assess signs and symptoms, and interpret protocols.

2. Be a minimum of 18 years of age at the beginning date of the certification program.

3. Certification as an EMT or higher EMS certification level.

4. Posses a high school or general equivalency diploma.

5. Have no physical or mental impairment that would render the student or provider unable to perform all practical skill required for that level of certification including the ability to function and communicate independently and perform appropriate patient care, physical assessments, and treatments.

6. If in a bridge certification program, the student shall be eligible for certification at the prerequisite lower ALS level at the beginning date of the bridge program and shall have obtained certification at the bridge program's prerequisite certification level before certification testing for the bridge level.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1523 EMT-Enhanced certification

A. The EMT-Enhanced curriculum will be the current Virginia Standard Curriculum for the EMT-Enhanced as approved by the Office of EMS.

B. Certification for the EMT-Enhanced course will be awarded upon successful completion of written and practical examinations administered by the Office of EMS.

C. EMT-Enhanced certification practical testing will follow practical testing guidelines as approved by the Office of EMS.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1524 Advanced EMT certification

A. The Advanced EMT curriculum will be the current Virginia Standard Curriculum for the Advanced EMT or Virginia education standards as approved by the Office of EMS.

B. Certification for the Advanced EMT course will be awarded upon successful completion of written and practical examinations administered by the Office of EMS.

C. Advanced EMT certification practical testing will follow practical testing guidelines as approved by the Office of EMS.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1525 Intermediate certification

A. The Intermediate curriculum will be the U.S. Department of Transportation National Standard Curriculum for the EMT-Intermediate 99 or a bridge program curriculum or Virginia education standards as amended and approved by the Office of EMS.

B. Certification for the Intermediate course will be awarded through reciprocity upon successful completion of written and practical examinations created and administered by the National Registry of Emergency Medical Technicians.

C. When the National Registry of Emergency Medical Technicians no longer tests EMT-Intermediate 99, the Board of Health will assume testing responsibilities for this level.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1527 Paramedic certification

A. The Paramedic curriculum will be the National Standard Curriculum for the Paramedic or a bridge program approved by the Office of EMS.

B. Certification for the Paramedic course will be awarded through reciprocity upon successful completion of written and practical examinations created and administered by the National Registry of Emergency Medical Technicians.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1529 Advanced life support bridge courses

A. Bridge courses are designed to allow a candidate to advance from a lower level of ALS certification to a higher level of ALS certification or for a Virginia licensed registered nurse to bridge to the Paramedic certification level:

1. EMT-Enhanced to Intermediate Bridge.

2. Intermediate to Paramedic Bridge.

3. RN to Paramedic Bridge.

B. All bridge programs shall use the training curriculum approved by the Office of EMS for the certification level of the program.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1530 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1531 Registered nurse to Paramedic bridge prerequisites

RN to Paramedic students must be able to document compliance with the following prerequisites:

1. The candidate must be currently licensed as an RN in Virginia or as recognized through the Nursing Compact Agreement as approved by the Virginia Board of Nursing.

2. The candidate must currently hold certification as a Virginia EMT or higher certification.

3. The candidate must be currently participating as an EMS field provider or actively working as an RN.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1533 Registered Nurse to Paramedic Bridge program completion requirements

A. The RN to Paramedic bridge curriculum shall be the National Standard Curriculum for the Paramedic or a bridge program derived from this curriculum approved by the Office of EMS.

B. The student will receive formal instruction in all the objectives listed in the Paramedic curriculum as recognized by the Office of EMS either through an accredited Paramedic course or through a nursing education program as recognized by the Virginia Board of Nursing.

C. Certification for the RN to Paramedic bridge course will be awarded through reciprocity upon successful completion of written and practical examinations created and administered by the National Registry of Emergency Medical Technicians.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1535 NREMT Paramedic endorsements

A. Physician assistants (PA) or nurse practitioners (NP) may receive Virginia endorsement to sit for the National Registry of EMT's Paramedic written and practical examinations after providing verification of successful completion of the following criteria:

1. The PA or NP shall be currently Virginia certified as an EMT-Basic or may be allowed, with written permission from the Office of EMS, to complete the 36 hour EMT-Basic continuing education (CE) hours and successfully complete the EMT-Basic written and practical certification examination.

2. The PA or the NP shall receive endorsement from an EMS physician who verifies the candidate satisfies the paramedic competencies by completing a form as prescribed by the Office of EMS.

3. Team leader skills shall be completed and verified on a form as prescribed by the Office of EMS.

B. Third and fourth year medical students, and Virginia licensed dentists or chiropractors may receive Virginia endorsement to sit for the National Registry of EMT-Paramedic written and practical examinations after providing successful completion of the following criteria:

1. Must possess or have possessed pre-hospital ALS certification that must not have expired more than 60 months prior to submission.

2. Must be currently certified as a Virginia EMT-Basic.

3. Third and fourth year medical students shall submit a copy of their official medical school transcripts. Dentists or chiropractors shall submit to the Office of EMS a copy of their license to practice in Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012; Errata 29:2 VA.R. 335-336 September 24, 2012.

12VAC5-31-1540 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

Article 7 EMT Instructor, ALS Coordinator, and EMS Education Coordinator

12VAC5-31-1541 Reserved

Article 7 EMT Instructor, ALS Coordinator, and EMS Education Coordinator

Historical Notes

Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1542 Reserved

Historical Notes

Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1543 EMT-Instructor recertification

This section will expire on October 10, 2014.

A. The EMT instructor's certification shall be renewed every two years. To fulfill the recertification requirements, the EMT instructor must:

1. Instruct a minimum of 50 hours of EMT or First Responder subject material in approved courses within the two-year certification period. This requirement only may be met through instruction of standard Basic Life Support training courses or other programs approved for Basic Life Support (Category 1) continuing education credit.

2. Successfully complete a minimum of one EMS instructor update within the two-year certification period.

3. Successfully complete the EMT written certification examination with a minimum passing score of 80%. This examination may be completed at any time following attendance of an EMS instructor update. If the EMT instructor is affiliated with a licensed EMS agency, this examination may be waived by the EMS agency's OMD.

B. Have no physical or mental impairment that would render the instructor unable to perform and evaluate all practical skills and tasks required of an EMT.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012; Errata 29:2 VA.R. 335-336 September 24, 2012.

12VAC5-31-1544 EMT-Instructor reentry

This section will expire on October 10, 2014.

Individuals whose EMT instructor certification has expired may regain full certification through completion of the reentry program within two years of their previous expiration date provided:

1. If the EMT instructor has completed the teaching requirements but is unable to fulfill one or more of the remaining requirements, the remaining requirements for recertification shall be completed within two years following the expiration date. However, if the required EMT examination was not completed prior to expiration, this examination may not be waived by an EMS Agency OMD.

2. If the EMT instructor has not completed the teaching requirements, the following requirements will be necessary for reentry:

a. Successful completion of the EMT instructor written and practical pretest examinations.

b. Attendance of the administrative portions of an EMT instructor institute.

3. Upon completion of the applicable requirements for reentry, new EMT instructor credentials will be issued for a two-year period. Thereafter, all of the requirements for recertification under 12VAC5-31-1545 will apply.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012; Errata 29:2 VA.R. 335-336 September 24, 2012.

12VAC5-31-1545 Reserved

Historical Notes

Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1546 Reserved

Historical Notes

Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1547 Renewal of Advanced Life Support coordinator

A. An ALS coordinator must maintain current certification as a Virginia ALS provider or licensure as a doctor of medicine, doctor of osteopathy, registered nurse, or physician assistant.

B. An ALS coordinator must resubmit an ALS coordinator certification application before his expiration month.

C. Successfully complete a minimum of one EMS instructor update or an ALS coordinator meeting within the two-year certification period.

D. A individual whose ALS coordinator certification has expired may regain full endorsement through completion of the reentry program within two years of his previous expiration date provided he:

1. Submits a completed ALS coordinator certification application; and

2. Successfully completes a minimum of one EMS instructor update or an ALS coordinator meeting within the two-year certification period.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1548 EMS Education coordinator

A. The EMS education coordinator may announce and teach courses at or below his provider certification level. An EMS education coordinator who certifies at a higher level may not begin announcing or coordinating courses at that level until they have attained one year of field experience at that level.

B. Performance of any medical procedure is not permitted based upon EMS education coordinator certification.

C. Current EMT instructors and ALS coordinators will be transitioned to EMS education coordinator within four years of (the effective date of these regulations).

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1549 EMS Education coordinator prerequisites

Prerequisites for certification as an EMS education coordinator are:

1. Be a minimum of 21 years of age.

2. Possess a high school diploma or equivalent.

3. Hold current Virginia EMS certifications as an EMT or higher level Virginia EMS certification.

4. Have three years medical experience with a minimum of two years verified field experience as an EMS provider at the appropriate EMS level or two years of current Virginia licensure as a registered nurse, physician assistant, doctor of osteopathic medicine, or doctor of medicine.

5. Must not have any EMS compliance enforcement actions within the previous five years.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1550 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1551 EMS education coordinator certification process

A. Eligible EMS education coordinator candidates will submit an application to include endorsement from an EMS physician.

B. Upon receipt and verification of the application, the eligible EMS education coordinator candidate will receive an eligibility to test letter and must complete a written and practical examination.

1. The EMS education coordinator application is valid for a period of two years from either primary test attempt date or 180 days after the application is approved, whichever is less. During this period of time, the candidate cannot submit another EMS education coordinator application.

2. An EMS education coordinator candidate written testing process shall have a primary and secondary attempt.

a. Primary written testing attempt is the first attempt at the EMS education coordinator written testing process.

b. Primary retest requires the candidate to retest the written test within 90 days of the date the primary test was attempted.

c. Secondary written testing occurs when a candidate fails the primary attempt and either fails the primary retest or does not retest within 90 days of the primary written attempt.

d. Secondary written test eligibility is initiated 90 days from the date of the failed primary retest or 180 days after the date of the failed primary test, whichever is less.

e. Secondary written retest requires the candidate to retest the written test within 90 days of the date the secondary test was attempted.

3. An EMS education coordinator candidate practical testing process shall have a primary and secondary attempt which cannot begin before the written primary test.

a. Primary practical testing attempt is the first attempt at the EMS education coordinator practical testing process.

b. Primary retest requires the candidate to retest that portion of the practical test failed. Same day retesting is allowed only if the candidate fails less than 75% of the practical test.

c. Secondary practical testing is initiated after practical primary retest failure and requires the candidate test all practical stations.

d. Secondary retest requires the candidate to retest that portion of the practical test failed. Same day retesting is allowed only if the candidate fails less than 75% of the secondary attempt on the practical testing.

C. After successfully completing the written and practical examination, the qualified eligible EMS education coordinator candidate shall attend training as required by OEMS.

D. All components of the EMS education coordinator certification process must be completed within two years from the end of the month of the primary test attempt or 180 days after approved and eligibility for testing is initiated, whichever is less.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1552 EMS education coordinator recertification process

A. To be eligible to recertify, the EMS education coordinator shall:

1. Maintain his provider certification.

2. Teach a minimum of 50 hours of initial certification or Category 1 CE and provide documentation of completion submitted in a process established by OEMS.

3. Complete one EMS education coordinator update in the three-year certification period.

4. Submit an EMS education coordinator application to include endorsement from an EMS physician.

B. Upon completion of the recertification requirements, the EMS education coordinator will receive an "Eligibility Notice" and must take and pass the EMS education coordinator recertification examination.

C. All recertification requirements must be completed and submitted to OEMS prior to the certification expiration date.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012; Errata 29:3 VA.R. 642 October 8, 2012.

12VAC5-31-1553 EMS education coordinator reentry

A. If an EMS education coordinator does not complete or submit all recertification requirements prior to his expiration date, he will go into a two-year reentry period.

B. During the reentry, the EMS education coordinator will not be allowed to coordinate any certification or CE courses. Any current courses in progress at the time of loss of EMS education coordinator certification will be suspended.

C. All outstanding recertification requirements shall be completed during the reentry period.

D. Failure to complete all recertification requirements during the reentry period will require the provider to complete the entire certification process as prescribed in 12VAC5-31-1551.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1560 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff October 10, 2012.

Article 8 EMS Training Fund

12VAC5-31-1561 EMS training fund

Article 8 EMS Training Fund

The Board of Health has established the emergency medical services training fund (EMSTF) to support certification and continuing education for BLS and ALS programs. Funding for various approved training programs will be administered on a contract basis between the EMT instructor, ALS coordinator, or EMS educational coordinator and the Office of EMS.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1563 Contracting through the EMS training fund

The Board of Health promulgates funding contracts for EMS training programs annually on July 1. Only EMT instructors, ALS coordinators, or EMS educational coordinators are eligible to submit funding contracts. The requirements of the funding contracts supersede these regulations as they are legal documents.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1565 Reserved

Historical Notes

Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1567 Reserved

Historical Notes

Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1570 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1580 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1590 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1600 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

Article 9 Accreditation of EMS Programs

12VAC5-31-1601 Accreditation of EMS training programs

Article 9 Accreditation of EMS Programs

A. Training programs that lead to eligibility for initial certification at the Advanced EMT, Intermediate and Paramedic level shall hold a valid accreditation issued by the Board of Health before any training programs are offered.

B. All certification programs seeking accreditation in Virginia shall comply with these regulations and the current version of the Standards and Guidelines for an Accredited Educational Program for the Emergency Medical Services Profession established by the Committee on Accreditation of Educational Programs for the Emergency Medical Services Professions (CoAEMSP) or an equivalent organization approved by the Board of Health.

C. The program director for an Advanced EMT, Intermediate, EMT-Enhanced (optional track) or EMT (optional track) program is exempt from the bachelor's degree requirement as specified by CoAEMSP standards.

D. The medical director required by CoAEMSP standards shall also meet the requirements for an OMD or PCD as required by these regulations.

E. All accredited programs shall notify the Board of Health immediately upon receiving notice about the following changes:

1. Program personnel to include:

a. The program director;

b. OMD or PCD; and

c. Primary faculty or instructional staff.

2. Additions or deletions to clinical site contracts and field site contracts.

3. Location.

4. Learning or teaching modalities.

5. Any sentinel event.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1603 Sentinel events

In cases where a sentinel event occurs, the commissioner may:

1. Place a program on probationary accreditation until the sentinel event is satisfactorily resolved; or

2. Revoke accreditation for the program.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1605 Initial accreditation

A. The initial accreditation process will begin upon the receipt by the Board of Health of an application for accreditation and a completed institutional self study.

B. EMT-Paramedic programs can obtain initial accreditation in one of two ways:

1. State accreditation by applying to the Board of Health for an initial grant of accreditation not to exceed five years.

2. Programs achieving accreditation issued by CoAEMSP or an equivalent organization approved by the Board of Health shall apply to the Office of EMS for state accreditation. Full accreditation will be issued for a period concurrent with that issued by the CoAEMSP or other approved organization up to a maximum of five years.

C. Advanced EMT and Intermediate programs can obtain accreditation by applying to the Board of Health for an initial grant of accreditation not to exceed five years.

D. EMT-Enhanced programs (optional track) can obtain accreditation by applying to the Board of Health for an initial grant of accreditation not to exceed five years.

E. EMT programs (optional track) can obtain accreditation by applying to the Board of Health for an initial grant of accreditation not to exceed five years.

F. The commissioner shall grant initial accreditation as follows:

1. The commissioner will issue full accreditation for a period of five years from the accreditation date if the accreditation analysis determines that the training program is in full compliance with the requirements for accreditation outlined in the appropriate section of EMS regulations.

2. The commissioner will issue provisional accreditation if the accreditation analysis and report identifies deficiencies that are determined to be of concern but do not justify prohibiting the program from starting and completing an initial training program. Before starting any additional certification courses, the program site must receive full accreditation by correcting the deficiencies identified in the accreditation analysis and report.

3. The commissioner will issue an accreditation denied status to the applicant if the accreditation analysis and report identifies deficiencies that are determined to be sufficient to prohibit the program from starting an initial training program.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1607 Renewal of accreditation

A. Paramedic program applicants shall only be renewed by obtaining a valid accreditation from the Committee on Accreditation of Allied Health Education Programs (CAAHEP), CoAEMSP or an equivalent organization approved by the Board of Health.

B. Advanced EMT and Intermediate, or EMT-Enhanced or EMT as optional tracks programs shall apply for renewal of their program accreditation not less than 270 days before the end of their current accreditation cycle. Reaccreditation will require submitting a new application for accreditation and an updated institutional self study. The institutional self study will be reviewed by a site review team which will determine the program's performance and provide the commissioner with a recommendation as to whether program accreditation should be renewed.

1. The commissioner will issue full accreditation for a period of five years from the reaccreditation date if the accreditation analysis determines that the training program is in full compliance with the requirements for accreditation outlined in the Virginia EMS regulations.

2. The commissioner will issue provisional reaccreditation if the accreditation analysis and report identifies deficiencies that are determined to be of concern but do not justify prohibiting the program from starting and completing an initial training program. Before starting any additional certification courses, the program site shall receive full accreditation by correcting the deficiencies identified at the reaccreditation date.

3. The commissioner shall issue an accreditation denied status to the applicant if the accreditation analysis identifies deficiencies that are determined to be sufficient to prohibit the program from starting an initial training program.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1609 Accreditation of alternative locations/learning sites

A. Accredited training programs in Virginia shall contact the Board of Health for accreditation of alternative training sites which differ from the site receiving initial accreditation.

B. Institutions that intend to operate entire programs or parts of programs at a different location or learning site shall prepare and submit on a form prescribed by the Board of Health for each additional location.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1610 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 23, Issue 5, eff. December 13, 2006; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1611 Appeal of site accreditation application results

Appeals by a program concerning the (i) denial of initial or renewal of accreditation or (ii) issuance of probationary accreditation shall be submitted in writing within 10 days to the Office of EMS pursuant to § 2.2-4019 of the Virginia Administrative Process Act.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1613 Accreditation of Paramedic programs

A. Paramedic programs with state accreditation shall be limited to one initial grant of state accreditation for a five year period.

B. Renewal of accreditation at the Paramedic level will be issued only upon verification of accreditation issued by CoAEMSP, CAAHEP, or another approved equivalent accreditation organization as specified in this chapter.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1615 Equivalent accreditation of EMS programs

A. The commissioner may issue an equivalent accreditation to programs obtaining a valid accreditation from the CAAHEP, CoAEMSP, or an equivalent organization approved by the Board of Health.

B. As a condition for equivalent accreditation, a representative from the Board of Health must be included with each visit by the CoAEMSP or any other approved accreditation organization.

1. Programs with equivalent accreditation shall notify the Board of Health immediately upon receiving notice about the following changes:

a. Scheduling of site team visits to include:

(1) Dates;

(2) Times; and

(3) The agenda or schedule of events.

b. Changes in program personnel to include:

(1) The program director; and

(2) OMD or PCD.

c. Changes or additions to, or deletions from clinical site contracts and field site contracts.

d. Notice of revocation, removal, or expiration of accreditation issued by CoAEMSP.

e. Any sentinel event.

2. Accreditation issued by CoAEMSP or other organization approved by the Board of Health shall remain current during any certification training program that requires accreditation by the Board of Health. Revocation, removal, or expiration of accreditation issued by CoAEMSP or other another organization approved by the Board of Health shall invalidate the corresponding state accreditation of the training program.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1620 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1630 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1640 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1650 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1660 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1670 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1680 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1690 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1700 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1710 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; repealed, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1720 [Reserved]. (Reserved)

12VAC5-31-1800 Requirement for EMS physician endorsement

A physician wishing to serve as an EMS agency operational medical director (OMD) or an EMS training program physician course director (PCD) shall hold current endorsement as an EMS physician issued by the Office of EMS.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-1810 Qualifications for EMS physician endorsement

A physician seeking endorsement as an EMS physician shall hold a current unrestricted license to practice medicine or osteopathy issued by the Virginia Board of Medicine. The applicant must submit documentation of his qualifications for review on a form prescribed by the Office of EMS. The documentation required shall present evidence of the following:

1. Board certification in emergency medicine or that applicant is in the active application process for board certification in emergency medicine issued by a national organization recognized by the Office of EMS, or board certification in family practice, internal medicine, or surgery or is in the active application process for board certification in family practice, internal medicine, or surgery issued by a national organization recognized by the Office of EMS. As an applicant under this section, a physician must also submit documentation of successful course completion or current certification in ACLS, ATLS, and PALS or present documentation of equivalent education in cardiac care, trauma care, and pediatric care completed within the past five years.

2. Completion of an EMS medical direction program approved by the Office of EMS prior to submitting application for consideration of endorsement as an EMS physician.

3. In the event that an EMS agency or training program is located in a geographic area that does not have available a physician meeting the requirements stated in subdivisions 1 or 2 of this section, or if an EMS agency has a specific need for a physician meeting specialized knowledge requirements (i.e., pediatrics, neonatology, etc.), then an available physician may submit his qualifications to serve as an EMS physician under these circumstances. An EMS physician endorsed under this subsection by the Office of EMS is limited to service within the designated geographic area or agency.

A physician seeking endorsement under this section must provide documentation of successful course completion or current certification in cardiac care, trauma care, and pediatric care or equivalent education such as ACLS, ATLS and PALS completed within one year of endorsement. All or part of this requirement may be waived if the Office of EMS determines this training is not required due to the specialized nature of the EMS agency to be served.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1820 Application for EMS physician endorsement

A. A physician seeking endorsement as an EMS physician must make application on forms provided by the Office of EMS.

B. The Office of EMS will review the application and the enclosed documents and notify the physician in writing of the status of his application within 30 days of receipt. Final disposition of an application may be delayed pending further review by the EMS Advisory Board Medical Direction Committee as applicable.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1830 Conditional endorsement

Physicians will be issued a conditional endorsement for a period of one year pending the completion of the following requirements:

1. Upon verification of EMS medical direction program attendance at one four-hour "Currents" session within the one-year conditional endorsement, the Office of EMS will reissue endorsement with an expiration date five years from the date of original issuance.

2. If the conditional EMS physician fails to complete the required EMS medical direction program or the training pursuant to 12VAC5-31-1810 within the initial one-year period, his endorsement will lapse.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1840 Lapse of EMS physician endorsement

A. If an EMS physician fails to reapply for endorsement prior to expiration, the Office of EMS will notify the EMS physician and any EMS agency or training course that the EMS physician is associated with of the loss of endorsement. Any training programs already begun may be completed under the direction of the involved EMS physician, but no other programs may be started or announced.

B. Any EMS agency notified of the loss of their OMD's EMS physician endorsement will be required to immediately obtain the services of another endorsed EMS physician to serve as operational medical director pursuant to Part II (12VAC5-31-300 et seq.) of these regulations.

C. Upon loss of EMS physician endorsement, a new endorsement may only be issued upon completion of the application requirements of these regulations.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1850 Change in EMS physician contact information

An EMS physician must report any changes of his name, contact addresses and contact telephone numbers to the Office of EMS within 30 days.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1860 Renewal of endorsement

A. Continued endorsement as an EMS physician requires submission of an application for renewal to the Office of EMS before expiration of the five-year endorsement period. Renewal of an EMS physician endorsement is based upon the physician's continuing to meet and maintain the qualifications specified in 12VAC5-31-1810.

B. Completion of equivalent related continuing education programs may be substituted for formal certification in ACLS, ATLS and PALS for the purposes of endorsement renewal. Acceptance of these continuing education hours is subject to approval by the Office of EMS.

C. An EMS physician must also attend a minimum of two "Currents" sessions as sponsored by OEMS within the five-year endorsement period.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1870 Service by an EMS physician

A. An endorsed EMS physician may serve within the limits of his endorsement as an operational medical director (OMD) or as a physician course director (PCD), or both.

B. The Office of EMS may limit the number and type of agencies or training programs an EMS physician may oversee in order to insure that appropriate medical direction and clinical oversight is available.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-1880 Agreement to serve as an operational medical director

A. An EMS physician may serve as the sole operational medical director (OMD) or one of multiple OMDs required for licensure of an EMS agency.

B. The EMS physician shall enter into a written agreement to serve as OMD with the EMS agency. This agreement shall at a minimum incorporate the specific responsibilities and authority as defined in 12VAC5-31-590.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1890 Responsibilities of operational medical directors

A. Responsibilities of the operational medical director regarding medical control functions include but are not limited to medical directions provided directly to prehospital providers by the OMD or a designee either on-scene or through direct voice communications.

B. Responsibilities of the operational medical director regarding medical direction functions include but are not limited to:

1. Using protocols, operational policies and procedures, medical audits, reviews of care and determination of outcomes for the purpose of establishing direction of education and limitation of provider patient care functions.

2. Verifying that qualifications and credentials for the agency's patient care or emergency medical dispatch personnel are maintained on an ongoing basis through training, testing and certification that, at a minimum, meet the requirements of these regulations, other applicable state regulations and including, but not limited to, § 32.1-111.5 of the Code of Virginia.

3. Functioning as a resource to the agency in planning and scheduling the delivery of training and continuing education programs for agency personnel.

4. Taking or recommending appropriate remedial or corrective measures for EMS personnel, consistent with state, regional and local EMS policies that may include but are not limited to counseling, retraining, testing, probation, and in-hospital or field internships.

5. Suspending certified EMS personnel from medical care duties pending review and evaluation. Following final review, the OMD shall notify the provider, the EMS agency and the Office of EMS in writing of the nature and length of any suspension of practice privileges that are the result of disciplinary action.

6. Reviewing and auditing agency activities to ensure an effective quality management program for continuous system and patient care improvement, and functioning as a resource in the development and implementation of a comprehensive mechanism for the management of records of agency activities including prehospital patient care and dispatch reports, patient complaints, allegations of substandard care and deviations from patient care protocols or other established standards.

7. Interacting with state, regional and local EMS authorities to develop, implement, and revise medical and operational protocols consistent with the Code of Virginia and dispatch protocols, policies, and procedures designed to deliver quality patient care. This function includes the selection and use of appropriate medications, supplies, and equipment.

8. Maintaining appropriate professional relationships with the local community including but not limited to medical care facilities, emergency departments, emergency physicians, allied health personnel, law enforcement, fire protection and dispatch agencies.

9. Establishing any other agency rules or regulations pertaining to proper delivery of patient care by the agency.

10. Providing for the maintenance of written records of actions taken by the OMD to fulfill the requirements of this section.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1900 OMD and EMS agency conflict resolution

A. In the event of an unresolved conflict between the OMD and an EMS agency, the issues involved must be brought before the medical direction committee of the regional EMS council or local EMS resource for review and resolution.

B. When the EMS agency presents a significant risk to public safety or health, the OMD must attempt to resolve the issues in question. If a risk remains unresolved and presents an immediate threat to public safety or health, the OMD shall contact the Office of EMS for assistance.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-1910 Change of operational medical director

A. An OMD choosing to resign must provide the agency and the Office of EMS a minimum of 30 days written notice of intent. When possible, the OMD should assist the agency in securing a successor for this position.

B. An agency choosing to secure the services of another OMD must provide a minimum of 30 days advance written notice of intent to the current OMD and the Office of EMS.

C. When extenuating circumstances require an immediate change of an agency's OMD (e.g., death, critical illness, etc.), the Office of EMS must be notified by the OMD within one business day so that a qualified replacement may be approved. In the event that the OMD is not capable of making this notification, the EMS agency will be responsible for compliance with this requirement. Under these extenuating circumstances, the Office of EMS may authorize the EMS agency to continue its operations pending the approval of a permanent or temporary replacement OMD.

D. When temporary circumstances make an agency's OMD unavailable to serve for a period not expected to exceed one year (e.g., military commitment, unexpected clinical conflict, etc.), the OMD must notify the Office of EMS within 10 business days so that a qualified interim replacement may be approved. Any circumstances that make an agency's OMD unavailable to serve for a period expected to exceed one-year will require a change in the agency OMD as required by this section.

E. The Office of EMS may delay implementation of a change in an EMS agency's OMD pending the completion of any investigation of an unresolved conflict or possible violation of these regulations or the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-1920 Responsibilities of physician course directors

A. Every basic or advanced life support training program and course requesting the award of certification or "Required" (Category 1) continuing education (CE) credits must have a minimum of one physician course director (PCD) who is a licensed physician holding endorsement as an EMS physician from the Office of EMS.

B. The PCD will have the following responsibilities as they relate to the selection and training of basic and advanced life support personnel:

1. The PCD must verify that all students accepted into the course of training meet state, regional, and local prerequisites for certification.

2. The PCD must confirm that all instructors for the course are certified at or above the level being instructed or have expertise in the particular subject being taught.

3. The PCD must regularly monitor and confirm that the training program adheres to the following criteria:

a. Satisfaction of the minimum objectives prescribed in the Office of EMS-approved training curriculum for the course of instruction. Upon presentation of an individual's "Virginia EMS Certification Application" for the PCD's signature by the course coordinator (ALS Coordinator) of an advanced life support training program, the PCD should confirm the student's successful completion of the course including their assessed competency to perform all required skills;

b. Continuing education programs are based upon the objectives prescribed in the Office of EMS approved recertification curriculum;

c. Consistency is maintained with local medical direction protocols and guidelines;

d. Consistency is maintained with any other local guidelines established by the regional EMS council or local EMS resource; and

e. Any additional requirements imposed for programs conducted for a single EMS agency or other organization must comply with the minimum guidelines defined in subdivisions 3 a through d of this subsection.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-1930 Compliance with training regulations

A. The PCD must verify that the course coordinator and all instructors are aware that possession or distribution of study guides or other written materials obtained through reconstruction of any state or national registry of EMTs certification examination is not permitted.

B. Where violations of this section or any part of these regulations are suspected of any PCD, the Office of EMS may suspend the instruction of any ongoing courses, withhold issuance of certifications, or suspend certifications issued to the course's students, instructors, or the course coordinator until an investigation is concluded.

Investigations resulting in a finding of a violation of these regulations by a PCD may result in an enforcement action. The Office of EMS may report the results of any investigation to the State Board of Medicine for further review and action as deemed necessary.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-1940 Physician course director responsibility to students

A. PCD/student relationship. The PCD shall assure that students are made aware of the PCD's responsibilities for the course, and of how to contact and if possible meet the PCD during the first lessons of any certification course.

B. Hospital-based experiences and field internships. The PCD shall provide clinical oversight and operational authority for the field practice of students enrolled in an approved EMS certification training program while the students are participating in clinical and field internship training. During these training programs the enrolled students may perform the clinical skills and functions of EMS personnel who are certified at the level of the course of instruction when:

1. The students are caring for patients in the affiliated hospitals or other healthcare-related facilities approved by the PCD, provided that the related didactic subject matter and practical skills laboratory have been completed and the students are under the direct supervision of a preceptor who is a physician, physician's assistant, nurse practitioner, registered nurse or an EMS provider certified at or above the level of the training program. All preceptors must be approved by the affiliated hospital or facility.

2. The students are caring for patients during a required course field internship program with a licensed EMS agency approved by the PCD, provided that the related didactic subject matter and practical skills laboratory have been completed and the students are under the direct supervision of and accompanied by an EMS provider certified at or above the level of the training program, or under the direct supervision of a licensed physician.

Nothing in this subsection removes the obligation of the supervising hospital, facility or licensed EMS agency for ultimate responsibility for provision of appropriate patient care by students participating in clinical or internship training.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003.

12VAC5-31-1950 Physician endorsement exemptions

A. Endorsement as an EMS physician will be initially issued to each licensed physician currently recorded as having previously been endorsed to serve as an operational medical director by the Office of EMS. Issuance of an EMS physician endorsement will be subject to renewal pursuant to 12VAC5-31-1860.

B. EMS physicians initially endorsed through the "grandfather" clause who fail to request renewal before expiration will be subject to compliance with the full provisions of 12VAC5-31-1810 in order to regain endorsement as an EMS physician.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 3, eff. January 15, 2003; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-1960 [Reserved]. (Reserved)

12VAC5-31-2000 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 19, Issue 3 and Volume 19, Issue 9, eff. January 15, 2003; Errata, 19:7 VA.R. 1119 December 16, 2002; repealed, Virginia Register Volume 23, Issue 6, eff. December 13, 2006.

12VAC5-31-2300 Purpose of designated regional EMS councils

For the purposes of these regulations regional EMS councils shall be designated by the Board of Health, adhere to policy direction established by the Office of EMS and carry out the development and implementation of an efficient and effective statewide regional EMS system.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2310 Provision of regional EMS council services within Virginia and compliance with these regulations

An organization or person providing designated regional EMS council services within Virginia must comply with these regulations, the applicable regulations of other state agencies, the Code of Virginia and the United States Code. The Office of EMS will publish the Virginia Regional EMS Council Designation Manual, a document that describes and provides guidance on how to comply with these regulations.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2320 Requirement for regional EMS council designation

Any organization or person establishing, operating, maintaining, advertising or representing itself or any services as a designated regional EMS council must have a valid designation issued by the Board of Health.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2330 Designation of a regional EMS council

A. The Board of Health will designate a regional EMS council that satisfies the representation requirements in these regulations.

B. The designation of a regional EMS council will be based on:

1. The "Regional EMS Council Designation Manual" application process.

a. Completed application. Submitted applications missing any information requested will be considered incomplete and will not be processed for designation;

b. Completed Regional EMS Council Self-Assessment Checklist; comply with all indicated standards consistent with these regulations;

c. Current roster of the membership of the applicant organization's board of directors. The roster needs to show all members of the board of directors for the applicant, their addresses, e-mail addresses, phone numbers, and the constituency they represent;

d. Current approved bylaws. A copy of the most recently approved bylaws complete with adoption date;

e. Scope of services. This shall include data and information that demonstrates the qualifications of the applicant to plan, initiate, expand or improve the regional EMS delivery system;

f. Budget. A proposed budget for the first year of designation must illustrate costs associated with the applicant's proposed operations and programs as a designated regional EMS council;

g. EMS involvement. Documentation demonstrating how the applicant organization interacts with EMS agencies and personnel;

h. Policies and guidelines. Up-to-date policies and guidelines covering all aspects of the applicant's regional EMS councils operations, must show revision date of all changes made and be consistent with these regulations;

i. Directory of localities, hospitals and EMS agencies. A comprehensive directory of the localities, hospitals and EMS agencies the applicant organization will be serving.

2. A listing of all hospitals within the applicant's proposed geographic service delivery area.

3. The demonstrated capability to establish communitywide and regional programs.

4. An evaluation of prior performance as a designated regional EMS council.

C. The Office of EMS will evaluate the performance and effectiveness of a regional EMS council on a periodic basis.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-2340 Application process for designation

A. An applicant for regional EMS council designation shall file a written application specified by the Office of EMS.

B. If the applicant is a company or corporation as defined in § 12.1-1 of the Code of Virginia it must clearly disclose the identity of its owners, officers and directors.

C. An applicant must provide information on any previous record of performance in the provision of related EMS services or any other related licensure, registration, certification or endorsement within or outside Virginia.

D. Completed application packages must be received in the Office of EMS no later than October 1 to be considered for designation commencing July 1 of the following year.

E. The application and preliminary review process is to be completed prior to a site review visit.

F. The Office of EMS may use whatever means of investigation necessary to verify any or all information contained in the application.

G. If the applicant organization does not comply with the required standards for designation as a regional EMS council, the agent of the applicant organization will be notified of the deficiencies by the Office of EMS.

H. If the applicant organization complies with the required standards, the agent of the applicant organization will be notified and arrangements will be made for a site visit by a review team as designated by the Office of EMS.

I. The Office of EMS will conduct a site review of the applicant.

J. The applicant organization will receive the written report of the visiting team reviewing its findings and recommendations in accordance with the criteria.

K. If a deficiency is reported, the Office of EMS may order the designated regional EMS council to correct the deficiency by issuing a written correction order.

L. If a deficiency requires a revisit by a site review team, a fee commensurate with direct costs will be paid by the applicant.

M. The site review process will be completed prior to the Office of EMS forwarding a recommendation for designation or denial to the Board of Health.

N. The Office of EMS will then forward a recommendation for designation or denial to the Board of Health.

O. Acting upon the favorable recommendation of the site review team and the Office of EMS, the Board of Health may designate the applicant organization as a regional EMS council.

P. The Office of EMS may schedule unannounced site visits at its discretion.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2350 Inspection

An applicant agency and all places of operation shall be subject to inspection by the Office of EMS for compliance with these regulations. The inspection may include any or all of the following:

1. All fixed places of operations, including all offices and training facilities;

2. All applicable records maintained by the applicant agency; and

3. All vehicles and required equipment used by the applicant agency.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2360 Designation approval

A. The Office of EMS will review and make recommendations to the Board of Health determining whether an applicant is qualified for designation based upon the applicant meeting the requirements of these regulations.

B. The Board of Health will make the final determination on regional EMS designation.

C. The designated regional EMS council or applicant has the right to appeal any decision or order of the Board of Health regarding approval or denial of regional EMS designation in accordance with the Virginia Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2370 Designation periods

The designation is for a period of three years, effective July 1, after completion of the designation process.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2380 Regional EMS councils requesting undesignation

Regional EMS councils desiring to become undesignated by the Board of Health must provide the Office of EMS a minimum of 30 days written notice of intent. Upon review the Office of EMS will forward the request to the Board of Health with its recommendation. Only the Board of Health can grant or remove regional EMS council designation.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2390 Powers and procedures of regulations not exclusive

The Board of Health reserves the right to authorize any procedure for the enforcement of these regulations that is not inconsistent with the provisions set forth herein or the provisions of §§ 32.1-27 and 32.1-111.1 of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2400 Exceptions

Exceptions to any provision of these regulations are specified as part of the regulation concerned. Any deviation not specified in these regulations is not allowed except by variance or exemption.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2410 Variances

A. The commissioner is authorized to grant variances for any part or all of these regulations in accordance with the procedures set forth herein. A variance permits temporary specified exceptions to these regulations. A designated regional EMS council may file a written request for a variance with the Office of EMS on specified forms.

1. The written variance request must be submitted for review and recommendations to the governing body of all localities in the service delivery area of the applicant or the designated regional EMS council prior to submission to the Office of EMS.

2. Issuance of a variance does not obligate localities to allow the conditions of such variance if they conflict with local ordinances or regulations.

B. Both the written request and the recommendation of the governing bodies must be submitted together to the Office of EMS.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2420 Issuance of a variance

A request for a variance may be approved and issued by the commissioner provided all of the following conditions are met:

1. The information contained in the request is complete and correct;

2. The regional EMS council concerned is designated by the Board of Health;

3. The Office of EMS determines the need for such a variance is genuine, and extenuating circumstances exist;

4. The Office of EMS determines that issuance of such a variance would be in the public interest and would not present any risk to, or threaten or endanger the public health, safety or welfare;

5. The Office of EMS will consider the recommendation of the governing body provided all of the above conditions are met; and

6. The agent of the designated regional EMS council making the request will be notified in writing of the approval and issuance within 30 days of receipt of the request unless the request is awaiting approval or disapproval of a designation. In such case, notice will be given within 30 days of the issuance of the designation.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2430 Content of variance

A variance shall include but not be limited to the following information:

1. The name of the designated regional EMS council to which the variance applies;

2. The expiration date of the variance;

3. The provision of the regulations that is to be varied and the type of variations authorized; and

4. Any special conditions that may apply.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2440 Conditions of variance

A variance shall be issued and remain valid with the following conditions:

1. A variance will be valid for a period not to exceed one year unless and until terminated by the commissioner;

2. A variance is neither transferable nor renewable under any circumstances.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2450 Termination of variance

A. The commissioner may terminate a variance at any time based upon any of the following:

1. Violations of any of the conditions of the variance;

2. Falsification of any information;

3. Suspension or revocation of the designation; and

4. A determination by the Office of EMS that continuation of the variance would present a risk to or threaten or endanger the public health, safety or welfare.

B. The Office of EMS will notify the agent of the designated regional EMS council of the termination by certified mail to his last known address.

C. Termination of a variance will take effect immediately upon receipt of notification unless otherwise specified.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2460 Denial of a variance

A request for a variance will be denied by the commissioner if any of the conditions of 12VAC5-31-2430 fail to be met.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2470 Exemptions

A. The Board of Health is authorized to grant exemptions from any part or all of these regulations in accordance with the procedures set forth herein. An exemption permits specified or total exceptions to these regulations for an indefinite period.

B. A designated regional EMS council may file a written request for an exemption with the Office of EMS on specified forms.

1. The written exemption request must be submitted for review and recommendations to the governing body of all localities in the service delivery area of the applicant or the designated regional EMS council prior to submission to the Office of EMS.

2. The written exemption request must be submitted to the Office of EMS a minimum of 30 days before the scheduled review by the governing bodies. At the time of submission, the applicant or designated regional EMS council must provide the Office of EMS with the date, time and location of the scheduled review by the governing bodies.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2480 Public notice of request for exemption

Upon receipt of a request for an exemption, the Office of EMS will cause notice of such request to be published in a newspaper of general circulation in the area wherein the service delivery area of the applicant or designated regional EMS council making the request and in other major newspapers of general circulation in major regions of the Commonwealth. The cost of such public notices will be borne by the applicant or designated regional EMS council making the request.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2490 Public hearing for exemption request

If the Board of Health determines that there is substantial public interest in a request for an exemption, a public hearing may be held.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2500 Issuance of an exemption

A. A request for an exemption may be approved and an exemption issued provided all of the following conditions are met:

1. The information contained in the request is complete and correct;

2. The need for such an exemption is determined to be genuine; and

3. The issuance of an exemption would not present any risk to, threaten or endanger the public health, safety or welfare of citizens.

B. The Board of Health may accept the recommendation of the governing bodies provided all of the conditions in subsection A of this section are met.

C. The agent of the designated regional EMS council making the request will be notified in writing of the approval or denial of a request.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2510 Content of exemption

An exemption includes but is not limited to the following information:

1. The name of the applicant or designated regional EMS council to whom the exemption applies;

2. The provisions of the regulations that will be exempted; and

3. Any special conditions that may apply.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2520 Conditions of exemption

A. An exemption remains valid for an indefinite period of time unless and until terminated by the Board of Health unless an expiration date is specified.

B. An exemption is neither transferable nor renewable.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2530 Termination of exemption

A. The Board of Health may terminate an exemption at any time based upon any of the following:

1. Violation of any of the conditions of the exemption;

2. Suspension or revocation of designation; and

3. A determination by the Office of EMS that continuation of the exemption would present risk to, or threaten or endanger the public health, safety or welfare.

B. The Office of EMS will notify the agent of the designated regional EMS council to whom the exemption was issued of the termination by certified mail to his last known address.

C. Termination of an exemption takes effect immediately upon receipt of notification unless otherwise specified.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2540 Denial of an exemption

A request for an exemption will be denied by the Board of Health if any of the conditions of these regulations fail to be met.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2550 Right to enforcement

A. The Office of EMS may use the enforcement procedures provided in this article when dealing with any deficiency or violation of these regulations or any action or procedure that varies from the intent of these regulations.

B. The Office of EMS may determine that a deficiency or violation of these regulations or any action or procedure that varies from the intent of these regulations occurred.

C. The enforcement procedures provided in this article are not mutually exclusive. The Office of EMS may invoke as many procedures as the situation may require.

D. The commissioner empowers the Office of EMS to enforce the provisions of these regulations.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2560 Enforcement actions

An enforcement action must be delivered to the agent of the affected designated regional EMS council and must specify information concerning the violations, the actions required to correct the violations and the specific date by which correction must be made as follows:

1. Warning: a verbal notification of an action or situation potentially in violation of these regulations.

2. Citation: a written notification for violations of these regulations.

3. Suspension: a written notification of the deactivation and removal of authorization issued under a designation.

4. Civil penalty: The commissioner (or designee) may impose a civil penalty to an agency or entity that fails or refuses compliance with these regulations. Civil penalties may be assessed up to $1,000 per offense. Violations shall be a single, different occurrence for each calendar day the violation occurs and remains uncorrected.

a. Subsequent violations of the same type may be subject to a civil penalty of $500 per calendar day, per violation.

b. Civil penalties will not exceed a combined total of $10,000.

5. Action of the commissioner: the commissioner may command a designated regional EMS council operating in violation of these regulations or state law pursuant to the commissioner's authority under § 32.1-27 of the Code of Virginia and the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) to halt such operation or to comply with applicable law or regulation. A separate and distinct offense will be deemed to have been committed on each day during which any prohibited act continues after written notice to the offender.

6. Criminal enforcement: the commissioner may elect to enforce any part of these regulations or any provision of Title 32.1 of the Code of Virginia by seeking to have criminal sanctions imposed as authorized by § 32.1-27 of the Code of Virginia. A separate and distinct offense will be deemed to have been committed on each day during which any prohibited act continues after written notice by the commissioner to the offender.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2570 Correction order

A. The Office of EMS may order the designated regional EMS council to correct a deficiency, cease any violations or comply with these regulations by issuing a written correction order as follows:

1. Correction orders may be issued in conjunction with any other enforcement action in response to individual violations or patterns of violations.

2. The Office of EMS will determine that a deficiency or violation exists before issuance of any correction order.

B. The Office of EMS will send a correction order to the agent of the designated regional EMS council by certified mail to his last known address or via personal service with written receipt. Notification will include, but not be limited to, a description of the deficiency or violation to be corrected, and the period within which the deficiency or situation must be corrected, which shall not be less than 30 days from receipt of such order, unless an emergency has been declared by the Office of EMS.

C. A correction order takes effect upon receipt and remains in effect until the deficiency is corrected or until the designation is suspended, revoked, or allowed to expire or until the order is overturned or reversed.

D. Should the designated regional EMS council be unable to comply with the correction order by the prescribed date, it may submit a request for modification of the correction order with the Office of EMS. The Office of EMS will approve or disapprove the request for modification of the correction order within 10 days of receipt.

E. The designated regional EMS council shall correct the deficiency or situation within the period stated in the order.

1. The Office of EMS will determine whether the correction is made by the prescribed date.

2. Should the designated regional EMS council fail to make the correction within the time period cited in the order, the Office of EMS may invoke any of the other enforcement procedures set forth in this part.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-2580 Suspension of a designation

A. The commissioner may suspend a designation without a hearing if the agency, organization or any of its personnel are found to be operating in a manner that presents a risk to, threatens, or endangers the public health, safety or welfare.

1. The commissioner may suspend the designation for failure to adhere to the standards set forth in these regulations.

2. The commissioner may suspend the designation for violation of federal or state laws resulting in a civil monetary penalty.

3. The commissioner may suspend the designation for conviction of criminal acts.

B. The Office of EMS will notify the agent of the designated regional EMS council of the suspension in person or by certified mail to his last known address.

C. A suspension takes effect immediately upon receipt of notification unless otherwise specified. A suspension remains in effect until the commissioner further acts upon the designation or until the order is overturned on appeal as specified in the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

D. The designated regional EMS council shall abide by any notice of suspension.

E. The commissioner may invoke any procedure set forth in this part to enforce the suspension.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2590 Revocation of a designation

A. The Board of Health may revoke the designation of a regional EMS council after a hearing or waiver thereof. Reasonable cause for revocation must exist before such action by the Board of Health. The Board of Health may revoke designation for the following:

1. Failure to adhere to the standards set forth in these regulations;

2. Violation of a correction order or for engaging in or aiding, abetting, causing, or permitting any act prohibited by these regulations;

3. Violation of federal or state laws resulting in a civil monetary penalty; and

4. Conviction of criminal acts.

B. The Office of EMS will notify the agent of the designated regional EMS council of the intent to revoke by certified mail to his last known address.

C. The designated regional EMS council will have the right to a hearing.

1. If the designated regional EMS council desires to exercise its right to a hearing, it must notify the Office of EMS in writing of his intent within 10 days of receipt of notification. In such cases, a hearing must be conducted and a decision rendered in accordance with the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

2. Should the designated regional EMS council fail to file such notice, he will be deemed to have waived the right to a hearing. In such case, the Board of Health may revoke the designation.

D. A revocation takes effect immediately upon receipt of notification unless otherwise specified. A revocation order is permanent unless and until overturned on appeal.

E. The designated regional EMS council shall abide by any notice of revocation.

F. The Office of EMS may invoke any procedures set forth in this part to enforce the revocation.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2600 Judicial review

A. The procedures of the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) control all judicial reviews.

B. The designated regional EMS council or applicant has the right to appeal any decision or order of the Office of EMS except as may otherwise be prohibited, and provided such a decision or order was not the final decision of an appeal.

C. The designated regional EMS council or applicant shall abide by any decision or order of the Office of EMS, or he must cease and desist pending any appeal.

D. If the designated regional EMS council or applicant who sought the appeal is aggrieved by the final decision, that person may seek judicial review as provided in the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2610 Submission of complaints

A. The Office of EMS will investigate complaints related to designation, operation and the delivery of services by regional EMS councils.

B. Any person may submit a complaint. A complaint is submitted in writing to the Office of EMS, signed by the complainant and includes the following information:

1. The name and address of the complainant;

2. The name of the designated regional EMS council or person involved; and

3. A detailed description of the complaint, including the date, location and conditions and the practice or act that exists or has occurred.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2620 Investigation process

A. The Office of EMS may investigate complaints received about conditions, practices, or acts that may violate any provision of either Article 2.1 (§ 32.1-111.1 et seq.) of Chapter 4 of Title 32.1 of the Code of Virginia or provision of these regulations.

B. If the Office of EMS determines that the conditions, practices, or acts cited by the complainant are not in violation of applicable sections of the Code of Virginia or these regulations; then the Office of EMS will investigate no further.

C. If the Office of EMS determines that the conditions, practices, or acts cited by the complainant may be in violation of applicable sections of the Code of Virginia or these regulations, the Office of EMS will investigate the complaint fully in order to determine if a violation took place.

D. The Office of EMS may investigate or continue to investigate and may take appropriate action on a complaint even if the original complainant withdraws his complaint or otherwise indicates a desire not to cause it to be investigated to completion.

E. The Office of EMS may initiate a formal investigation or action based on an anonymous or unwritten complaint.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2630 Action by the Office of EMS

A. If the Office of EMS determines that a violation has occurred, it may apply all provisions of these regulations that it deems necessary and appropriate.

B. At the completion of an investigation and following any appeals, the Office of EMS will notify the complainant.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2640 [Reserved]

Historical Notes

Reserved, Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2650 Composition of designated regional EMS councils

A designated regional EMS council shall include, if available, representatives of the participating local governments, fire protection agencies, law-enforcement agencies, emergency medical services agencies, hospitals, licensed practicing physicians, emergency care nurses, mental health professionals, emergency medical technicians and other appropriate allied health professionals.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2660 Governing body of a designated regional EMS council

A. A regional EMS council shall be organizationally independent of any other entity.

B. A regional EMS council shall be governed by a board.

C. Articles of incorporation and bylaws shall be in force that specify:

1. Designated regional EMS council representation;

2. Method of designated regional EMS council appointments and/or elections;

3. Governing board representation;

4. Method of governing board appointments and/or elections;

5. Tenure of representatives;

6. Officers, their roles, responsibilities and terms of office;

7. Quorum requirements;

8. Meeting attendance requirements and enforcement policies;

9. Indemnification of officers and directors; and

10. Dissolution of assets.

D. There shall be a minimum of five members with full voting privileges comprising a governing board.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2670 Regional EMS plan

A designated regional EMS council, in cooperation with the Governor's EMS Advisory Board, shall develop, maintain, and distribute a comprehensive regional EMS plan for coordinating and improving the delivery of EMS in the regional service area, in accordance with §§ 32.1-111.3 and 32.1-111.11 of the Code of Virginia.

1. The plan shall be submitted for approval by the Office of EMS within one year of designation.

2. The approved plan shall be distributed to the Office of EMS, all localities, EMS agencies, hospitals and EMS physicians within its service delivery area.

3. The plan shall be reviewed and revised, if necessary, every three years and redistributed to the Office of EMS, all localities, EMS agencies, hospitals and EMS physicians within its service delivery area.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2680 Regional trauma triage plan

A designated regional EMS council, in corporation with the Governor's EMS Advisory Board, shall develop, maintain, and distribute a regional trauma triage plan in accordance with §§ 32.1-111.3 and 32.1-111.11 of the Code of Virginia.

1. The plan shall be submitted for approval by the Office of EMS within one year of designation.

2. The approved plan shall be distributed to the Office of EMS, all localities, EMS agencies, hospitals and EMS physicians within its service delivery area.

3. The plan shall be reviewed and revised, if necessary, every three years and submitted for approval by the Office of EMS.

4. The approved revisions shall be distributed to the Office of EMS, all localities, EMS agencies, hospitals and EMS physicians within its service delivery area.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2690 [Reserved]

Historical Notes

Reserved, Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2700 Financial assistance for emergency medical services

A. A designated regional EMS council shall participate in the Virginia financial assistance for emergency medical services program and assist eligible EMS agencies and organizations needing funding within the service area.

B. The designated regional EMS council participation in the Virginia financial assistance for emergency medical services program process shall have written guidelines and procedures, approved by the Office of EMS, that meet the requirements stated in 12VAC5-31-2810 through 12VAC5-31-2900.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2710 Base funding of designated regional EMS councils

A. Required services provided by a designated regional EMS council may be funded by the state.

B. A designated regional EMS council may receive annual base funding by the state to assist with infrastructure development and maintenance in providing required regional services.

C. A designated regional EMS council shall submit documentation, as required, demonstrating a 25% match for base funding to the Office of EMS. Moneys received directly or indirectly from the Commonwealth shall not be used as matching funds.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2720 Matching funds

For the purposes of these regulations, approved matching funds are monetary and/or in-kind services as approved by the Office of EMS and only apply to base funding.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2730 Performance standards

A. The Office of EMS may enter into performance-based contracts that establish standards for the delivery of specific identified services and projects with designated regional EMS councils. These services and projects shall include, but not be limited to, performance standards for:

1. Regional medical direction;

2. Regional EMS plan;

3. Trauma triage plan;

4. EMS performance improvement program;

5. Regional trauma performance improvement program;

6. Technical assistance and review for Rescue Squad Assistance Fund grant applications;

7. Regional infrastructure; and

8. Criteria for matching funds.

B. The contracts will be based upon the specific needs of the regional service delivery area and the requirements of the Office of EMS as described in § 32.1-111.11 of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2740 Accountability for public funds

A. A designated regional EMS council shall maintain a current operating statement, reflecting revenue and expenditures, available for review.

B. A designated regional EMS council shall have a current income and expenditure statement available at all governing board meetings.

C. A designated regional EMS council shall have an independent annual audit of financial records with management letters conducted by a certified public accountant.

D. A designated regional EMS council shall have an independent review of financial records conducted by a certified public accountant upon change of an executive director.

E. A designated regional EMS council shall retain all books, records, and other documents relative to public funds for six years after the close of the fiscal year the funds were received. The Office of EMS, its authorized agents, and/or state auditors shall have full access to and the right to examine any materials related to public funds during said period.

F. A designated regional EMS council shall follow generally accepted accounting principles for financial management.

G. A designated regional EMS council's governing board shall approve its annual fiscal year (July 1 through June 30) budget by July 15 of each year.

H. A designated regional EMS council shall comply with all appropriate federal and state tax-related reporting.

I. A designated regional EMS council shall follow generally accepted fund raising practices in the charitable field.

J. A designated regional EMS council shall have written policies that indicate by position, signatories of executed financial and contractual instruments.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008; amended, Virginia Register Volume 29, Issue 1, eff. October 10, 2012.

12VAC5-31-2750 [Reserved]

Historical Notes

Reserved, Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2760 [Reserved]

Historical Notes

Reserved, Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2770 [Reserved]

Historical Notes

Reserved, Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2780 [Reserved]

Historical Notes

Reserved, Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2790 [Reserved]

Historical Notes

Reserved, Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2800 [Reserved]

Historical Notes

Reserved, Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2810 The Financial Assistance and Review Committee (FARC)

A. Financial Assistance and Review Committee appointments.

1. Appointments shall be made for terms of three years or the unexpired portions thereof in a manner to preserve, insofar as possible, the representation of the emergency medical services councils. No member may serve more than two successive terms. The chairman shall be elected from the membership of the FARC for a term of one year and shall be eligible for reelection.

2. The EMS Advisory Board may revoke appointment for failure to adhere to the standards set forth in this chapter, and the State and Local Government Conflict of Interests Act (§ 2.2-3100 et seq. of the Code of Virginia).

3. Members serving on the FARC on January 1, 2008, shall complete their current terms of office.

4. Midterm vacancies shall be filled by nominations submitted from the affected designated regional EMS council.

B. Geographical representation.

1. Designated regional EMS councils shall be eligible to submit nominations to the EMS Advisory Board for representation on the FARC.

2. The eligible designated regional EMS council shall nominate three candidates to fill a vacancy on the FARC. The EMS Advisory Board shall make appointments from the nominations submitted by the designated regional EMS council.

3. A designated regional EMS council whose representative has completed two successive terms on FARC shall not be eligible to submit a nomination for one full term (three years).

C. Meetings and attendance.

1. The FARC shall meet at least four times annually at the call of the chairman or the commissioner.

2. Attendance at FARC Grant Review meetings is mandatory for all members.

3. A quorum for a meeting of the FARC shall consist of not fewer than four members.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.3 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008; amended, Virginia Register Volume 32, Issue 6, eff. January 4, 2016.

12VAC5-31-2820 RSAF General Grant Program administration

A. The FARC will administer the RSAF (Rescue Squad Assistance Fund) General Grant Program and the funding of RSAF General Grant awards using the Office of EMS approved pricing, applicant eligibility, award criteria, and priorities as approved by the EMS Advisory Board.

B. The Office of EMS shall approve and maintain a list that represents an average price of EMS vehicles, EMS equipment, communications equipment, and EMS education programs frequently requested under the RSAF General Grant Program. This list will be based on current market pricing and is not all-inclusive. RSAF General Grant awards for items maintained on this list shall not exceed the approved amount.

C. Funding priorities for RSAF General Grants shall be identified in the Virginia Statewide EMS Plan as stipulated in § 32.1-111.3 of the Code of Virginia or special initiatives as approved by the EMS Advisory Board.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2830 Award of RSAF General Grants

A. The requirements of this section shall apply to the disbursement of funds.

B. A nonprofit licensed EMS agency or other Virginia emergency medical service organization operating on a nonprofit basis exclusively for the benefit of the general public pursuant to § 32.1-111.12 of the Code of Virginia is eligible for an RSAF General Grant.

C. An applicant must be in compliance with this chapter.

D. Programs, services, and equipment funded by the RSAF must comply with the plans, policies, procedures, and guidelines adopted by the EMS Advisory Board. Grants may be approved for the following:

1. Establishment of a new EMS agency, program, or service where needed to improve emergency medical services offered in an area;

2. Expansion or improvement of an existing EMS agency, program, or service;

3. Replacement of equipment or procurement of new equipment; or

4. Establishment, expansion or improvement of EMS training programs.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.3 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008; amended, Virginia Register Volume 32, Issue 6, eff. January 4, 2016.

12VAC5-31-2840 RSAF General Grant award cycle

A. The grant period shall be for a period of 12 months from the date of award and there shall be two review cycles per year.

B. Deadline for submission of applications shall be March 15 and September 15 of each year. Applications must be received in the Office of EMS by 5 p.m. of the date of the deadline. In the event the deadline falls on a Saturday, Sunday, or state or federal holiday, the application must be received by 5 p.m. in the Office of EMS the next business day.

C. Applications shall be made to the Office of EMS on an approved application form.

D. Dates of award shall be July 1 and January 1 of each year.

E. Other dates in the award process shall be established by the Office of EMS.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.3 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008; amended, Virginia Register Volume 32, Issue 6, eff. January 4, 2016.

12VAC5-31-2850 Emergency awards

A. The commissioner empowers the Office of EMS the ability to implement Emergency Grant Awards. The Office of EMS will advise the EMS Advisory Board and FARC of emergency grants awarded and the purpose(s) of disbursement of these funds.

B. Applications shall be made to the Office of EMS on an approved application form at any time.

C. The Emergency Grant Award will be made or rejected by the Office of EMS within 10 business days after receiving an application on an approved form.

D. Award of funds shall be based upon the demonstrated needs arising from a natural or man-made disaster as defined in § 44-146.16 of the Code of Virginia.

E. Award of funds shall be based upon incidents or circumstances involving the loss or potential loss of critical equipment or services.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2860 EMS System Initiative Awards

EMS System Initiative Awards are based on priorities and needs identified by the EMS Advisory Board in consultation with the Office of EMS to meet EMS system objectives as stipulated in § 32.1-111.3 of the Code of Virginia.

1. The Office of EMS or FARC, in consultation with EMS Advisory Board, may implement EMS System Initiative Awards at any time. Examples of such awards would include medically advanced equipment with broad application (automated external defibrillation) and information technology to enhance communications and data (computers).

2. EMS System Initiative Award applications shall be submitted on the Office of EMS approved form, using approved pricing, application eligibility award criteria, and approved priorities.

3. The EMS System Initiative Award will be made or rejected by the Office of EMS within 30 business days after receiving an application on an approved form.

4. EMS System Initiative Awards may be granted for the following purposes, based upon the demonstrated need:

a. Establishment of a new EMS agency, program, or service where needed to improve emergency medical services offered in an area;

b. Expansion or improvement of an existing EMS agency, program, or service;

c. Replacement of equipment or procurement of new equipment; or

d. Establishment, expansion or improvement of EMS training programs.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.3 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008; amended, Virginia Register Volume 32, Issue 6, eff. January 4, 2016.

12VAC5-31-2870 Responsibilities of the grantee

A. Grantee shall not discriminate in the provisions of its services or in the conduct of its business affairs on the basis of race, color, creed, religion, sex, national origin, or disability.

B. Grantee must comply with these regulations. The grantee shall be responsible for ensuring that item(s) purchased in whole or in part with the use of the state moneys comply with these regulations.

C. Grantee shall be responsible for the preparation and maintenance of proper accounting records that shall be maintained for a period of not less than five years from the end of the grant period.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2880 Application for award

A. Applications shall be made to the Office of EMS.

B. The Office of EMS will review applications for compliance with the EMS regulations and RSAF policies and procedures. The FARC reviews and grades applications and makes recommendations on general grant funding.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.3 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008; amended, Virginia Register Volume 32, Issue 6, eff. January 4, 2016.

12VAC5-31-2890 [Reserved]

Historical Notes

Reserved, Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2900 Awards

A. The Office of EMS shall make awards as approved by the commissioner.

B. Grantees will be notified of their award.

C. Funds may be disbursed to the grantee at any time within the grant period. Agreement to the award and any attached conditions shall be secured prior to any disbursements.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.3 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008; amended, Virginia Register Volume 32, Issue 6, eff. January 4, 2016.

12VAC5-31-2910 Amount of grant award

A. The amount of RSAF General Grant award granted an applicant will not exceed 50% of the cost of the item(s) except in documented and approved cases of hardship. The amount of an RSAF General Grant award shall be based upon the amount requested for the item(s) and state approved pricing determined by the Office of EMS. The amount awarded will not exceed the amount requested by the applicant.

B. Additional funding may be recommended for those unique situations where the applicant has demonstrated the lack of reasonable capability to generate a 50% match (hardship). The additional funding above a 50% match will be determined by the FARC.

1. Awards identified on the notice of award as being "hardship" (above a 50% match level) require the grantee to purchase from available state contracts.

Awardees, able to demonstrate the ability to purchase at a cost equal to or less than the state contract price, may purchase outside the state contract with prior approval.

2. The FARC shall recommend the percentage of an RSAF General Grant award based upon the review of the application.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2920 Use of funds

A. Awards shall be made in accordance with § 32.1-111.12 of the Code of Virginia.

B. Funds shall be used only for the specific items, service, or programs for which they were awarded and in accordance with any conditions placed upon a grant award.

C. The grantee shall sign an agreement form attesting that the award funds shall be used as granted and the grantee meets all conditions placed upon the award.

D. Sale, trade, transfer, or disposal, within five years of vehicles or items specified by the Office of EMS in the notice of award purchased in whole or in part with the use of state moneys requires prior approval by the Office of EMS.

E. EMS vehicles purchased with funding from the RSAF shall meet the current state and federal standards for the type of vehicle purchased.

F. Funds shall not be used for expenditures or commitments made before the date of the grant award or after the conclusion of the grant period.

G. Funds shall not be approved or disbursed for:

1. Leased equipment or vehicle;

2. Equipment or vehicles secured by a lien;

3. Guarantees or warranties;

4. Used equipment or vehicles without prior approval; or

5. Fire suppression apparatus or law-enforcement equipment.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.3 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008; amended, Virginia Register Volume 32, Issue 6, eff. January 4, 2016.

12VAC5-31-2930 Ownership

All equipment, including EMS vehicles, shall be in the name of the organization to which the award has been made or in the name of the local jurisdiction or government entity in which the organization is located. This requirement shall apply to the ownership of equipment purchased in whole or in part with the use of these funds.

A copy of the title for each EMS vehicle shall be provided to the Office of EMS.

History

• Statutory Authority: §§ 32.1-12 and 32.1-111.3 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008; amended, Virginia Register Volume 32, Issue 6, eff. January 4, 2016.

12VAC5-31-2940 Improper expenditures

A. An audit revealing expenditures not permitted by the conditions of the award will result in the grantee being required to reimburse the Office of EMS any funds received.

B. An agency providing false, misleading or improper information to the Office of EMS will be ineligible for future grants for a period of five years.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2950 Modification of an award

Any changes in the project, including any changes in the approved item(s), shall be permitted only by modification of the award.

1. The grantee must request in writing the specific modifications desired and the reasons and circumstances necessitating such a request to the Office of EMS.

2. The commissioner may modify, approve or deny the request for modification.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2960 Suspension of an award

A. The commissioner may suspend an award and all disbursements of funds attached pending an investigation and following an informal fact-finding conference as defined in the Virginia Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

B. There shall exist reasonable cause for suspension prior to such action by the commissioner. Such cause shall include:

1. Failure to comply with these regulations;

2. Violation of the terms of any conditions or agreements attached to an award; or

3. A reasonable belief by the commissioner that any such violations might otherwise continue unabated.

C. The Office of EMS shall notify the grantee of the suspension by certified mail to the last known address.

D. A suspension shall take effect immediately upon receipt of notification unless otherwise specified. A suspension shall remain in effect until reinstated or revoked by the commissioner.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

12VAC5-31-2970 Revocation of an award

The commissioner may revoke an award and all disbursements of funds attached after an informal fact-finding conference as defined in the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) or waiver thereof.

1. Cause. There must exist reasonable cause for revocation prior to such action by the commissioner.

2. Notification. The Office of EMS must notify the grantee of the revocation by certified mail to the last known address.

3. Period of effect. A revocation shall be permanent unless and until overturned on appeal.

History

• Statutory Authority: §§ 32.1-12, 32.1-111.4, and 32.1-111.11 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. January 1, 2008.

Chapter 90 Regulations for Disease Reporting and Control

Part I Definitions

12VAC5-90-10 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Affected area" means any part or the whole of the Commonwealth that has been identified as where persons reside or may be located who are known to have been exposed to or infected with, or who are reasonably suspected to have been exposed to or infected with, a communicable disease of public health threat. "Affected area" includes cities, counties, towns, and subsections of such areas, public and private property, buildings, and other structures.

"Arboviral infection" means a viral illness that is transmitted by a mosquito, tick, or other arthropod. This includes chikungunya (CHIK), dengue, eastern equine encephalitis (EEE), LaCrosse encephalitis (LAC), also known as California encephalitis, St. Louis encephalitis (SLE), West Nile virus (WNV), and Zika virus (Zika) infection.

"Board" means the State Board of Health.

"Cancer" means all carcinomas, sarcomas, melanomas, leukemias, and lymphomas excluding localized basal and squamous cell carcinomas of the skin, except for lesions of the mucous membranes.

"CDC" means the Centers for Disease Control and Prevention of the U.S. Department of Health and Human Services.

"Child care center" means a child day center, child day program, family day home, family day system, or registered family day home as defined by § 63.2-100 of the Code of Virginia, or a similar place providing day care of children by such other name as may be applied.

"Clinic" means any facility, freestanding or associated with a hospital, that provides preventive, diagnostic, therapeutic, rehabilitative, or palliative care or services to outpatients.

"Commissioner" means the State Health Commissioner or the State Health Commissioner's duly designated officer or agent, unless stated in a provision of this chapter that it applies to the State Health Commissioner in the State Health Commissioner's sole discretion.

"Communicable disease" means an illness due to an infectious agent or its toxic products that is transmitted, directly or indirectly, to a susceptible host from an infected person, animal, or arthropod or through the agency of an intermediate host or a vector or through the inanimate environment.

"Communicable disease of public health significance" means an illness caused by a specific or suspected infectious agent that may be transmitted directly or indirectly from one individual to another. This includes infections caused by human immunodeficiency viruses, bloodborne pathogens, and tubercle bacillus. The State Health Commissioner may determine that diseases caused by other pathogens constitute communicable diseases of public health significance.

"Communicable disease of public health threat" means an illness of public health significance, as determined by the State Health Commissioner in accordance with this chapter, caused by a specific or suspected infectious agent that may be reasonably expected or is known to be readily transmitted directly or indirectly from one individual to another and has been found to create a risk of death or significant injury or impairment; this definition shall not, however, be construed to include human immunodeficiency viruses or the tubercle bacilli, unless used as a bioterrorism weapon.

"Companion animal" means, consistent with the provisions of § 3.2-6500 of the Code of Virginia, any domestic or feral dog, domestic or feral cat, nonhuman primate, guinea pig, hamster, rabbit not raised for human food or fiber, exotic or native animal, reptile, exotic or native bird, or any feral animal or any animal under the care, custody, or ownership of a person or any animal that is bought, sold, traded, or bartered by any person. Agricultural animals, game species, or any animals regulated under federal law as research animals are not considered companion animals for the purpose of this chapter.

"Condition" means any adverse health event, such as a disease, an infection, a syndrome, or as indicated by a procedure, including the results of a physical exam, laboratory test, or imaging interpretation, suggesting that an exposure of public health importance has occurred.

"Contact" means a person or animal known to have been in such association with an infected person or animal as to have had an opportunity of acquiring the infection.

"Contact services" means a broad array of services that are offered to persons with infectious diseases and their contacts. Contact services include contact tracing, providing information about current infections, developing risk reduction plans to reduce the chances of future infections, and connecting to appropriate medical care and other services.

"Contact tracing" means the process by which an infected person or health department employee notifies others that they may have been exposed to the infected person in a manner known to transmit the infectious agent in question.

"Coronavirus infection, severe" means suspected or confirmed infection with severe acute respiratory syndrome (SARS)-associated coronavirus (SARS-CoV), Middle East respiratory syndrome (MERS)-associated coronavirus (MERS-CoV), or another coronavirus causing a severe acute illness.

"Decontamination" means the use of physical or chemical means to remove, inactivate, or destroy hazardous substances or organisms from a person, surface, or item to the point that such substances or organisms are no longer capable of causing adverse health effects and the surface or item is rendered safe for handling, use, or disposal.

"Department" means the State Department of Health, also referred to as the Virginia Department of Health (VDH).

"Designee" or "designated officer or agent" means any person or group of persons designated by the State Health Commissioner to act on behalf of the commissioner or the board.

"Ehrlichiosis/Anaplasmosis" means human infections caused by Ehrlichia chaffeensis (formerly included in the category "human monocytic ehrlichiosis" or "HME"), Ehrlichia ewingii or Anaplasma phagocytophilum (formerly included in the category "human granulocytic ehrlichiosis" or "HGE").

"Epidemic" means the occurrence in a community or region of cases of an illness clearly in excess of normal expectancy.

"Essential needs" means basic human needs for sustenance, including food, water, clothing, and health care (e.g., medications, therapies, testing, and durable medical equipment).

"Exceptional circumstances" means the presence, as determined by the commissioner in the commissioner's sole discretion, of one or more factors that may affect the ability of the department to effectively control a communicable disease of public health threat. Factors to be considered include (i) characteristics or suspected characteristics of the disease-causing organism or suspected disease-causing organism such as virulence, routes of transmission, minimum infectious dose, rapidity of disease spread, the potential for extensive disease spread, and the existence and availability of demonstrated effective treatment; (ii) known or suspected risk factors for infection; (iii) the potential magnitude of the effect of the disease on the health and welfare of the public; and (iv) the extent of voluntary compliance with public health recommendations. The determination of exceptional circumstances by the commissioner may take into account the experience or results of investigation in Virginia, another state, or another country.

"Foodborne outbreak" means two or more cases of a similar illness acquired through the consumption of food contaminated with chemicals or an infectious agent or its toxic products. Such illnesses include heavy metal intoxication, staphylococcal food poisoning, botulism, salmonellosis, shigellosis, Clostridium perfringens food poisoning, hepatitis A, and Shiga toxin-producing Escherichia coli infection.

"Health care-associated infection" (also known as nosocomial infection) means a localized or systemic condition resulting from an adverse reaction to the presence of an infectious agent or its toxin that (i) occurs in a patient in a health care facility (e.g., a medical care facility or outpatient clinic), and (ii) was not found to be present or incubating at the time of admission unless the infection was related to a previous admission to the same setting.

"Immunization" means a procedure that increases the protective response of an individual's immune system to specified pathogens.

"Independent pathology laboratory" means a nonhospital or a hospital laboratory performing surgical pathology, including fine needle aspiration biopsy and bone marrow specimen examination services, that reports the results of such tests directly to physician offices, without reporting to a hospital or accessioning the information into a hospital tumor registry.

"Individual" means a person or companion animal. When the context requires it, "person " shall be deemed to include any individual.

"Infection" means the entry and multiplication or persistence of a disease-causing organism (prion, virus, bacteria, fungus, parasite, or ectoparasite) in the body of an individual. An infection may be inapparent (i.e., without recognizable signs or symptoms but identifiable by laboratory means) or manifest (clinically apparent).

"Influenza, laboratory-confirmed" means by culture, antigen detection by direct fluorescent antibody (DFA), or nucleic acid detection. Influenza rapid antigen tests are not reportable.

"Influenza A, novel virus" means infection of a human with an influenza A virus subtype that is different from currently circulating human influenza H1 and H3 viruses. Novel subtypes include H2, H5, H7, and H9 subtypes or influenza H1 and H3 subtypes originating from a nonhuman species or from genetic reassortment of human and animal influenza viruses.

"Invasive" means the organism is affecting a normally sterile site, including blood or cerebrospinal fluid.

"Investigation" means an inquiry into the incidence, prevalence, extent, source, mode of transmission, causation of, and other information pertinent to a disease occurrence.

"Isolation" means the physical separation, including confinement or restriction of movement, of an individual who is infected with, or is reasonably suspected to be infected with, a communicable disease in order to prevent or limit the transmission of the communicable disease to uninfected and unexposed individuals.

"Isolation, complete" means the full-time confinement or restriction of movement of an individual infected with, or reasonably suspected to be infected with, a communicable disease in order to prevent or limit the transmission of the communicable disease to uninfected and unexposed individuals.

"Isolation, modified" means a selective, partial limitation of freedom of movement or actions of an individual infected with, or reasonably suspected to be infected with, a communicable disease. Modified isolation is designed to meet particular situations and includes the exclusion of children from school, the prohibition or restriction from engaging in a particular occupation or using public or mass transportation, or requirements for the use of devices or procedures intended to limit disease transmission.

"Isolation, protective" means the physical separation of a susceptible individual not infected with, or not reasonably suspected to be infected with, a communicable disease from an environment where transmission is occurring, or is reasonably suspected to be occurring, in order to prevent the individual from acquiring the communicable disease.

"Laboratory" means a clinical laboratory that examines materials derived from the human body for the purpose of providing information on the diagnosis, prevention, or treatment of disease.

"Laboratory director" means any person in charge of supervising a laboratory conducting business in the Commonwealth of Virginia.

"Law-enforcement agency" means any sheriff's office, police department, adult or youth correctional officer, or other agency or department that employs persons who have law-enforcement authority that is under the direction and control of the Commonwealth or any local governing body. "Law-enforcement agency" shall include, by order of the Governor, the Virginia National Guard.

"Lead, reportable blood levels" means any detectable blood lead level in children 15 years of age and younger and levels greater than or equal to 5 μg/dL in a person older than 15 years of age.

"Least restrictive" means the minimal limitation of the freedom of movement and communication of an individual while under an order of isolation or an order of quarantine that also effectively protects unexposed and susceptible individuals from disease transmission.

"Medical care facility" means any hospital or nursing home licensed in the Commonwealth or any hospital operated by or contracted to operate by an entity of the United States government or the Commonwealth of Virginia.

"Midwife" means any person who is licensed as a nurse midwife by the Virginia Boards of Nursing and Medicine or who is licensed by the Board of Medicine as a certified professional midwife.

"National Healthcare Safety Network" or "NHSN" means a surveillance system created by the CDC for accumulating, exchanging, and integrating relevant information on infectious adverse events associated with health care delivery.

"Nucleic acid detection" means laboratory testing of a clinical specimen to determine the presence of deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) specific for an infectious agent using any method, including hybridization, sequencing, or amplification such as polymerase chain reaction.

"Nurse" means any person licensed as a professional nurse or as a licensed practical nurse by the Virginia Board of Nursing.

"Occupational outbreak" means a cluster of illness or disease that is indicative of a work-related exposure. Such conditions include silicosis, asbestosis, byssinosis, pneumoconiosis, and tuberculosis.

"Outbreak" means the occurrence of more cases of a disease than expected.

"Period of communicability" means the time during which the etiologic agent may be transferred directly or indirectly from an infected person to another person or from an infected animal to a person.

"Physician" means any person licensed to practice medicine or osteopathy by the Virginia Board of Medicine.

"Quarantine" means the physical separation, including confinement or restriction of movement, of individuals who are present within an affected area or who are known to have been exposed, or may reasonably be suspected to have been exposed, to a communicable disease and who do not yet show signs or symptoms of infection with the communicable disease in order to prevent or limit the transmission of the communicable disease of public health threat to unexposed and uninfected individuals.

"Quarantine, complete" means the full-time confinement or restriction of movement of individuals who do not have signs or symptoms of infection but may have been exposed, or may reasonably be suspected to have been exposed, to a communicable disease of public health threat in order to prevent the transmission of the communicable disease of public health threat to uninfected individuals.

"Quarantine, modified" means a selective, partial limitation of freedom of movement or actions of individuals who do not have signs or symptoms of the infection but have been exposed to, or are reasonably suspected to have been exposed to, a communicable disease of public health threat. Modified quarantine may be designed to meet particular situations and includes limiting movement to the home, work, or one or more other locations, the prohibition or restriction from using public or mass transportation, or requirements for the use of devices or procedures intended to limit disease transmission.

"Reportable disease" means an illness due to a specific toxic substance, occupational exposure, or infectious agent that affects a susceptible individual, either directly, as from an infected animal or person, or indirectly through an intermediate host, vector, or the environment, as determined by the board.

"School" means (i) any public school from kindergarten through grade 12 operated under the authority of any locality within the Commonwealth; (ii) any private or religious school that offers instruction at any level or grade from kindergarten through grade 12; and (iii) any private or religious nursery school or preschool, or any private or religious child care center required to be licensed by the Commonwealth.

"Serology" means the testing of blood, serum, or other body fluids for the presence of antibodies or other markers of an infection or disease process.

"Surveillance" means the ongoing systematic collection, analysis, and interpretation of outcome-specific data for use in the planning, implementation, and evaluation of public health practice. A surveillance system includes the functional capacity for data analysis as well as the timely dissemination of these data to persons who can undertake effective prevention and control activities.

"Susceptible individual" means a person or animal who is vulnerable to or potentially able to contract a disease or condition. Factors that affect an individual's susceptibility include physical characteristics, genetics, previous or chronic exposures, chronic conditions or infections, immunization history, or use of medications.

"Toxic substance" means any substance, including any raw materials, intermediate products, catalysts, final products, or by-products of any manufacturing operation conducted in a commercial establishment, that has the capacity through its physical, chemical, or biological properties to pose a substantial risk of death or impairment either immediately or over time to the normal functions of humans, aquatic organisms, or any other animal but not including any pharmaceutical preparation, which deliberately or inadvertently is consumed in such a way as to result in a drug overdose.

"Tubercle bacilli" means disease-causing organisms belonging to the Mycobacterium tuberculosis complex and includes Mycobacterium tuberculosis, Mycobacterium africanum, Mycobacterium bovis, Mycobacterium canetti, Mycobacterium microti, Mycobacterium caprae, and other members as may be established by the commissioner.

"Tuberculosis, active disease" (also "active tuberculosis disease" and "active TB disease"), as defined by § 32.1-49.1 of the Code of Virginia, means a communicable disease caused by an airborne microorganism and characterized by the presence of either (i) a specimen of sputum or other bodily fluid or tissue that has been found to contain tubercle bacilli as evidenced by culture or nucleic acid amplification, including preliminary identification by rapid methodologies; (ii) a specimen of sputum or other bodily fluid or tissue that is suspected to contain tubercle bacilli as evidenced by smear, and where sufficient clinical and radiographic evidence of active tuberculosis disease is present as determined by a physician licensed to practice medicine in Virginia; or (iii) sufficient clinical and radiographic evidence of active tuberculosis disease as determined by the commissioner is present, but a specimen of sputum or other bodily fluid or tissue containing, or suspected of containing, tubercle bacilli is unobtainable.

"Tuberculosis infection " means a positive result from a test for tuberculosis infection without clinical or other evidence of active tuberculosis disease.

"Vaccinia, disease or adverse event" means vaccinia infection or serious or unexpected events in persons who received the smallpox vaccine or their contacts, including bacterial infections, eczema vaccinatum, erythema multiforme, generalized vaccinia, progressive vaccinia, inadvertent inoculation, post-vaccinial encephalopathy or encephalomyelitis, ocular vaccinia, and fetal vaccinia.

"Waterborne outbreak" means two or more cases of a similar illness acquired through the ingestion of or other exposure to water contaminated with chemicals or an infectious agent or its toxic products. Such illnesses include giardiasis, viral gastroenteritis, cryptosporidiosis, hepatitis A, cholera, and shigellosis. A single case of laboratory-confirmed primary amebic meningoencephalitis or of waterborne chemical poisoning is considered an outbreak.

History

• Statutory Authority: §§ 32.1-12, 32.1-35, and 32.1-42 of the Code of Virginia.
• Historical Notes: Derived from VR355-28-100 § 1.1, eff. July 1, 1993; amended, Virginia Register Volume 15, Issue 6, eff. January 6, 1999; Errata, 15:8 VA.R. 1099 January 4, 1999; amended, Virginia Register Volume 20, Issue 21, eff. July 28, 2004; Volume 23, Issue 15, eff. May 2, 2007; Volume 27, Issue 13, eff. March 28, 2011; Volume 33, Issue 2, eff. October 20, 2016; Volume 36, Issue 6, eff. December 26, 2019; Volume 41, Issue 26, eff. September 10, 2025.

Part II General Information

12VAC5-90-20 Authority

Chapter 2 of Title 32.1 of the Code of Virginia deals with the reporting and control of diseases. Specifically, § 32.1-35 directs the Board of Health to promulgate regulations specifying which diseases occurring in the Commonwealth are to be reportable and the method by which they are to be reported. Further, § 32.1-42 of the Code of Virginia authorizes the board to promulgate regulations and orders to prevent a potential emergency caused by a disease dangerous to the public health. Section 32.1-12 of the Code of Virginia empowers the Board of Health to adopt such regulations as are necessary to carry out provisions of laws of the Commonwealth administered by the Commissioner of the Department of Health.

History

• Statutory Authority: §§ 32.1-12 and 32.1-35 of the Code of Virginia.
• Historical Notes: Derived from VR355-28-100 § 2.1, eff. July 1, 1993.

12VAC5-90-30 Purpose

This chapter is designed to provide for the uniform reporting of diseases of public health importance occurring within the Commonwealth in order that appropriate control measures may be instituted to reduce the occurrence of disease.

History

• Statutory Authority: § 32.1-35 of the Code of Virginia.
• Historical Notes: Derived from VR355-28-100 § 2.2, eff. July 1, 1993; amended, Virginia Register Volume 27, Issue 13, eff. March 28, 2011.

12VAC5-90-40 Administration

A. The State Board of Health ("board") has the responsibility for promulgating regulations pertaining to the reporting and control of diseases of public health importance and to meet any emergency or to prevent a potential emergency caused by a disease dangerous to the public health including but not limited to specific procedures for responding to any disease listed pursuant to § 32.1-35 of the Code of Virginia that is determined to be caused by an agent or substance used as a weapon or any communicable disease of public health threat that is involved in an order of quarantine or an order of isolation pursuant to Article 3.02 (§ 32.1-48.05 et seq.) of the Code of Virginia.

B. The State Health Commissioner ("commissioner") is the executive officer for the State Board of Health with the authority of the board when it is not in session, subject to the rules and regulations of and review by the board. The commissioner has the authority to require quarantine, isolation, immunization, decontamination, or treatment of any individual or group of individuals when he determines any such measure to be necessary to control the spread of any disease of public health importance and has the authority to issue orders of isolation pursuant to Article 3.01 (§ 32.1-48.01 et seq.) of the Code of Virginia and orders of quarantine and orders of isolation under exceptional circumstances involving any communicable disease of public health threat pursuant to Article 3.02 (§ 32.1-48.05 et seq.) of the Code of Virginia.

C. The local health director is responsible for the surveillance and investigation of those diseases specified by this chapter which occur in his jurisdiction. He is further responsible for reporting all such surveillance and investigations to the Office of Epidemiology. In cooperation with the commissioner, he is responsible for instituting measures for disease control, which may include implementing the quarantine and isolation orders of the commissioner.

D. The Office of Epidemiology, an organizational part of the department, is responsible for the statewide surveillance of those diseases specified by this chapter, for defining and disseminating appropriate disease control protocols for an outbreak situation, for coordinating the investigation of those diseases with the local health director, and for providing direct assistance where necessary. The Director of the Office of Epidemiology acts as the commissioner's designee in reviewing reports and investigations of diseases and recommendations by local health directors for quarantine or isolation. However, authority to order quarantine or isolation resides solely with the commissioner.

E. All persons responsible for the administration of this chapter shall ensure that the anonymity of patients and practitioners is preserved, according to state and federal law including the provisions of §§ 32.1-38, 32.1-41, and 32.1-71 of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-35 of the Code of Virginia.
• Historical Notes: Derived from VR355-28-100 § 2.3, eff. July 1, 1993; amended, Virginia Register Volume 15, Issue 6, eff. January 6, 1999; Volume 20, Issue 21, eff. July 28, 2004; Volume 23, Issue 15, eff. May 2, 2007.

12VAC5-90-50 (Repealed.)

History

• Historical Notes: Derived from VR355-28-100 § 2.4, eff. July 1, 1993; amended, Virginia Register Volume 15, Issue 6, eff. January 6, 1999; repealed, Virginia Register Volume 33, Issue 2, eff. October 20, 2016.

12VAC5-90-60 (Repealed.)

Historical Notes

Derived from VR355-28-100 § 2.5, eff. July 1, 1993; repealed, Virginia Register Volume 15, Issue 6, eff. January 6, 1999.

12VAC5-90-70 Powers and procedures of chapter not exclusive

The board reserves the right to authorize a procedure for enforcement of this chapter which is not inconsistent with the provisions set forth herein and the provisions of Chapter 2 (§ 32.1-35 et seq.) of Title 32.1 of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-35 of the Code of Virginia.
• Historical Notes: Derived from VR355-28-100 § 2.6, eff. July 1, 1993; amended, Virginia Register Volume 15, Issue 6, eff. January 6, 1999.

Part III Reporting of Disease

12VAC5-90-80 Lists of diseases that shall be reported

A. The persons enumerated in 12VAC5-90-90 shall report the following named diseases, toxic effects, and conditions pursuant to this chapter. A condition identified by an asterisk (*) requires immediate communication to the local health department by the most rapid means available upon suspicion or confirmation, as defined in subsection C of this section. Other conditions shall be reported within three days of suspected or confirmed diagnosis, unless otherwise specified in this section. Neonatal Abstinence Syndrome shall be reported as specified in subsection E of this section. Coronavirus disease 2019 (SARS-CoV-2) shall be reported as specified in subsection I of the section.

Alpha-gal Syndrome (AGS)

Amebiasis (Entamoeba histolytica)

*Anthrax (Bacillus anthracis)

Arboviral infections (e.g., CHIK, dengue, EEE, LAC, SLE, WNV, Zika)

Babesiosis (Babesia spp.)

*Botulism (Clostridium botulinum)

*Brucellosis (Brucella spp.)

Campylobacteriosis (Campylobacter spp.)

Candida auris, infection or colonization

Carbapenemase-producing organism, infection, or colonization

Chancroid (Haemophilus ducreyi)

Chickenpox (Varicella virus)

Chlamydia trachomatis infection

*Cholera (Vibrio cholerae O1 or O139)

*Coronavirus infection, severe (e.g., SARS-CoV, MERS-CoV)

Coronavirus disease 2019 (COVID-19 or SARS-CoV-2)

Cryptosporidiosis (Cryptosporidium spp.)

Cyclosporiasis (Cyclospora spp.)

*Diphtheria (Corynebacterium diphtheriae)

*Disease caused by an agent that may have been used as a weapon

Ehrlichiosis/Anaplasmosis (Ehrlichia spp., Anaplasma phagocytophilum)

Giardiasis (Giardia spp.)

Gonorrhea (Neisseria gonorrhoeae)

Granuloma inguinale (Calymmatobacterium granulomatis)

*Haemophilus influenzae infection, invasive

Hantavirus pulmonary syndrome

Hemolytic uremic syndrome (HUS)

*Hepatitis A

Hepatitis B (acute and chronic)

Hepatitis C (acute and chronic)

Hepatitis, other acute viral

Human immunodeficiency virus (HIV) infection

Influenza, laboratory-confirmed

*Influenza-associated deaths if younger than 18 years of age

Lead, reportable blood levels

Legionellosis (Legionella spp.)

Leprosy (Hansen's disease) (Mycobacterium leprae)

Leptospirosis (Leptospira interrogans)

Listeriosis (Listeria monocytogenes)

Lyme disease (Borrelia spp.)

Lymphogranuloma venereum (Chlamydia trachomatis)

Malaria (Plasmodium spp.)

*Measles (Rubeola)

*Meningococcal disease (Neisseria meningitidis)

Mumps

Neonatal abstinence syndrome (NAS)

Ophthalmia neonatorum

*Orthopoxviruses (e.g., Monkeypox virus, Variola virus, Vaccinia disease or adverse event)

*Outbreaks, all (including foodborne, health care-associated, occupational, toxic substance-related, waterborne, and any other outbreak)

*Pertussis (Bordetella pertussis)

*Plague (Yersinia pestis)

*Poliovirus infection, including poliomyelitis

*Psittacosis (Chlamydophila psittaci)

*Q fever (Coxiella burnetii)

*Rabies, human and animal

Rabies treatment, post-exposure

*Rubella, including congenital rubella syndrome

Salmonellosis (Salmonella spp.)

Shiga toxin-producing Escherichia coli infection

Shigellosis (Shigella spp.)

Spotted fever rickettsiosis (Rickettsia spp.)

Streptococcal disease, Group A, invasive or toxic shock

Streptococcus pneumoniae infection, invasive if younger than five years of age

Syphilis (Treponema pallidum) report *congenital, *primary, *secondary, and other

Tetanus (Clostridium tetani)

Toxic substance-related illness

Trichinosis (Trichinellosis) (Trichinella spiralis)

*Tuberculosis, active disease (Mycobacterium tuberculosis complex)

Tuberculosis infection

*Tularemia (Francisella tularensis)

*Typhoid/Paratyphoid infection (Salmonella Typhi, Salmonella Paratyphi)

*Unusual occurrence of disease of public health concern

Vancomycin-intermediate or vancomycin-resistant Staphylococcus aureus infection

*Vibriosis (Vibrio spp.)

*Viral hemorrhagic fever

*Yellow fever

Yersiniosis (Yersinia spp.)

B. A laboratory director shall report test results indicative of and specific for the diseases, infections, microorganisms, conditions, and toxic effects specified in this subsection for humans. Tests include microbiological culture, isolation, or identification; assays for specific antibodies; and identification of specific antigens, toxins, or nucleic acid sequences. Additional condition-specific requirements are noted in this subsection and subsection D of this section. A condition identified by an asterisk (*) requires immediate communication to the local health department by the most rapid means available upon suspicion or confirmation, as defined in subsection C of this section. Other conditions shall be reported within three days of suspected or confirmed diagnosis.

Alpha-gal Syndrome (AGS) - Serum or plasma immunoglobulin E specific to alpha-gal (sIgE) test results of ≥0.1 IU/mL or ≥0.1 kU/L

Amebiasis (Entamoeba histolytica)

*Anthrax (Bacillus anthracis)

Arboviral infection, for example, CHIK, dengue, EEE, LAC, SLE, WNV, or Zika

Babesiosis (Babesia spp.)

*Botulism (Clostridium botulinum)

*Brucellosis (Brucella spp.)

Campylobacteriosis (Campylobacter spp.)

Candida auris - Include available antimicrobial susceptibility findings in report.

Carbapenemase-producing organism - Include available antimicrobial susceptibility findings in report.

Chancroid (Haemophilus ducreyi)

Chickenpox (Varicella virus)

Chlamydia trachomatis infection

*Cholera (Vibrio cholerae O1 or O139)

*Coronavirus infection, severe (e.g., SARS-CoV, MERS-CoV)

Coronavirus disease 2019 (COVID-19 or SARS-CoV-2)

Cryptosporidiosis (Cryptosporidium spp.)

Cyclosporiasis (Cyclospora spp.)

*Diphtheria (Corynebacterium diphtheriae)

Ehrlichiosis/Anaplasmosis (Ehrlichia spp., Anaplasma phagocytophilum)

Giardiasis (Giardia spp.)

Gonorrhea (Neisseria gonorrhoeae) - Include available antimicrobial susceptibility findings in report.

*Haemophilus influenzae infection, invasive

Hantavirus pulmonary syndrome

*Hepatitis A

Hepatitis B (acute and chronic) - For all hepatitis B patients, also report available results of serum alanine aminotransferase (ALT) and all available results from the hepatitis panel.

Hepatitis C (acute and chronic) - For all patients with any positive HCV test, also report all results of HCV viral load tests, including undetectable viral loads and report available results of serum alanine aminotransferase (ALT) and all available results from the hepatitis panel.

Hepatitis, other acute viral - Any finding indicative of acute infection with hepatitis D, E, or other cause of viral hepatitis. For any reportable hepatitis finding, submit all available results from the hepatitis panel.

Human immunodeficiency virus (HIV) infection - For HIV-infected patients, report all results of CD4 and HIV viral load tests, including undetectable viral loads. For HIV-infected patients, report all HIV genetic nucleotide sequence data associated with HIV drug resistance tests by electronic submission. For children younger than three years of age, report all tests regardless of the test findings (e.g., negative or positive).

Influenza, laboratory-confirmed - By culture, antigen detection by direct fluorescent antibody (DFA), or nucleic acid detection.

Lead, reportable blood levels - All lead results from tests of venous or capillary blood performed by a laboratory certified by the Centers for Medicare and Medicaid Services in accordance with 42 USC § 263a, the Clinical Laboratory Improvement Amendment of 1988 (CLIA-certified).

Legionellosis (Legionella spp.)

Leptospirosis (Leptospira interrogans)

Listeriosis (Listeria monocytogenes), invasive or if associated with miscarriage or stillbirth from placental or fetal tissue

Lyme disease (Borrelia spp.)

Malaria (Plasmodium spp.)

*Measles (Rubeola)

*Meningococcal disease (Neisseria meningitidis), invasive - Include identification of gram-negative diplococci.

Mumps

*Mycobacterial diseases - (See 12VAC5-90-225 ) Report any of the following:

1. Acid fast bacilli;

2. M. tuberculosis complex or any other mycobacteria; or

3. Antimicrobial susceptibility results for M. tuberculosis complex.

*Orthopoxviruses (e.g., Monkeypox virus, Variola virus, Vaccinia disease or adverse event)

*Pertussis (Bordetella pertussis)

*Plague (Yersinia pestis)

*Poliovirus infection

*Psittacosis (Chlamydophila psittaci)

*Q fever (Coxiella burnetii)

*Rabies, human and animal

*Rubella

Salmonellosis (Salmonella spp.)

Shiga toxin-producing Escherichia coli infection

Shigellosis (Shigella spp.)

Spotted fever rickettsiosis (Rickettsia spp.)

Streptococcal disease, Group A, invasive or toxic shock

Streptococcus pneumoniae infection, invasive if younger than five years of age

*Syphilis (Treponema pallidum)

Toxic substance-related illness - By blood or urine laboratory findings above the normal range, including heavy metals, pesticides, and industrial-type solvents and gases. When applicable and available, report speciation of metals when blood or urine levels are elevated in order to differentiate the chemical species (elemental, organic, or inorganic).

Trichinosis (Trichinellosis) (Trichinella spiralis)

Tuberculosis infection

*Tularemia (Francisella tularensis)

*Typhoid/Paratyphoid infection (Salmonella Typhi, Salmonella Paratyphi A, Salmonella Paratyphi B, Salmonella Paratyphi C)

Vancomycin-intermediate or vancomycin-resistant Staphylococcus aureus infection - Include available antimicrobial susceptibility findings in report.

*Vibriosis (Vibrio spp., Photobacterium damselae, Grimontia hollisae), other than toxigenic Vibrio cholera O1 or O139, which are reportable as cholera

*Viral hemorrhagic fever

*Yellow fever

Yersiniosis (Yersinia spp.)

C. Certain of the diseases in the list of reportable diseases require immediate identification and control because of their extremely contagious nature, potential for greater harm, or availability of a specific intervention that must be administered in a timely manner. Reporting of persons confirmed or suspected of having these diseases, listed in this subsection, shall be made immediately by the most rapid means available, preferably by telephone to the local health department. (These same diseases are also identified by an asterisk (*) in subsections A and B, where applicable, of this section.)

Anthrax (Bacillus anthracis)

Botulism (Clostridium botulinum)

Brucellosis (Brucella spp.)

Cholera (Vibrio cholerae O1 or O139)

Coronavirus infection, severe (e.g., SARS-CoV, MERS-CoV)

Diphtheria (Corynebacterium diphtheriae)

Disease caused by an agent that may have been used as a weapon

Haemophilus influenzae infection, invasive

Hepatitis A

Influenza-associated deaths if younger than 18 years of age

Influenza A, novel virus

Measles (Rubeola virus)

Meningococcal disease (Neisseria meningitidis)

Outbreaks, all

Orthopoxviruses (e.g., Monkeypox virus, Variola virus, Vaccinia disease or adverse event)

Pertussis (Bordetella pertussis)

Plague (Yersinia pestis)

Poliovirus infection, including poliomyelitis

Psittacosis (Chlamydophila psittaci)

Q fever (Coxiella burnetii)

Rabies, human and animal

Rubella, including congenital rubella syndrome

Syphilis, congenital, primary, and secondary (Treponema pallidum)

Tuberculosis, active disease (Mycobacterium tuberculosis complex)

Tularemia (Francisella tularensis)

Typhoid/Paratyphoid infection (Salmonella Typhi, Salmonella Paratyphi (all types))

Unusual occurrence of disease of public health concern

Vibriosis (Vibrio spp., Photobacterium damselae, Grimontia hollisae), other than toxigenic Vibrio cholerae O1 or O139, which are reportable as cholera

Viral hemorrhagic fever

Yellow fever

D. A laboratory identifying evidence of any of the conditions in this subsection shall notify the local health department of the positive culture or other positive test result within the timeframes specified in subsection B of this section and submit the initial isolate (preferred) within five days or the clinical specimen within two days of a positive result to the Division of Consolidated Laboratory Services or other public health laboratory where specified in this subsection. A specimen or isolate must be identified with the patient and physician information required in 12VAC5-90-90 C.

Anthrax (Bacillus anthracis)

Botulism (Clostridium botulinum)

Brucellosis (Brucella sp.)

Candida auris

Candida haemulonii

Carbapenem-resistant Enterobacterales

Carbapenem-resistant Pseudomonas aeruginosa

Cholera (Vibrio cholerae O1 or O139)

Coronavirus infection, severe (e.g., SARS-CoV, MERS-CoV)

Diphtheria (Corynebacterium diphtheriae)

Haemophilus influenzae infection, invasive

Influenza, unsubtypeable

Listeriosis (Listeria monocytogenes)

Meningococcal disease (Neisseria meningitidis)

Pertussis (Bordetella pertussis)

Plague (Yersinia pestis)

Poliovirus infection

Q fever (Coxiella burnetii)

Salmonellosis (Salmonella spp.)

Shiga toxin-producing E. coli infection. A laboratory that identifies a Shiga toxin but does not perform simultaneous culture for Shiga toxin-producing E. coli should forward all positive stool specimens or positive enrichment broths to the Division of Consolidated Laboratory Services for confirmation and further characterization.

Shigellosis (Shigella spp.)

Streptococcal disease, Group A, invasive

Tuberculosis. A laboratory identifying Mycobacterium tuberculosis complex (see 12VAC5-90-225) shall submit a representative and viable sample of the initial culture to the Division of Consolidated Laboratory Services or other laboratory designated by the board to receive the specimen.

Tularemia (Francisella tularensis)

Typhoid/Paratyphoid infection (Salmonella Typhi, Salmonella Paratyphi (all types))

Vancomycin-intermediate or vancomycin-resistant Staphylococcus aureus infection

Vibriosis (Vibrio spp., Photobacterium damselae, Grimontia hollisae)

Yersiniosis (Yersinia spp.)

Other diseases as may be requested by the health department.

E. A physician or director of a medical care facility shall report neonatal abstinence syndrome if a newborn has been diagnosed with neonatal abstinence syndrome, a condition characterized by clinical signs of withdrawal from exposure to prescribed or illicit drugs. A report shall be submitted within one month of diagnosis by entering the information into the Department of Health's online Confidential Morbidity Report portal (https://www.vdh.virginia.gov/clinicians/disease-reporting-and-control-regulations/).

F. The occurrence of an outbreak or cluster of any illness that may represent a group expression of an illness that may be of public health concern shall be reported to the local health department immediately by the most rapid means available, preferably by telephone.

G. Toxic substance-related illnesses, including pesticide and heavy metal poisoning or illness resulting from exposure to an occupational dust or fiber or radioactive substance, shall be reported.

If the illness is verified or suspected and presents an emergency or a serious threat to public health or safety, the report of such illness shall be made immediately by the most rapid means available, preferably by telephone.

H. An unusual or emerging condition of public health concern shall be reported to the local health department immediately by the most rapid means available, preferably by telephone. In addition, the commissioner or the commissioner's designee may establish surveillance systems for diseases or conditions that are not on the list of reportable diseases to identify cases (delineate the magnitude of the situation), to identify the mode of transmission and risk factors for the disease, and to identify and implement appropriate action to protect public health. A person reporting information at the request of the department for special surveillance or other epidemiological studies shall be immune from liability as provided by § 32.1-38 of the Code of Virginia.

I. A physician or medical care facility director shall report coronavirus disease 2019, also known as COVID-19, if a person who is infected with SARS-CoV-2 or who is suspected of having COVID-19 is treated or examined, hospitalized, or admitted into the intensive care unit. A physician or medical care facility director shall report the person's name, telephone number, address, age, date of birth, race, ethnicity, sex, and pregnancy status; name of disease diagnosed or suspected; the medical record number (if applicable); the date of onset of illness; available laboratory tests and results; and the name, address, and telephone number of the physician and medical facility where the examination was made. A case report shall be submitted within three days of the suspicion or confirmation of disease by entering the information into the Virginia Department of Health online Confidential Morbidity Report portal at https://www.vdh.virginia.gov/clinicians/disease-reporting-and-control-regulations/ or via electronic case reporting (https://www.vdh.virginia.gov/meaningful-use/meaningful-use-submissions-of-electronic-case-reports/).

J. A laboratory director, including a director of another entity that holds Clinical Laboratory Improvement Amendments Certificates of Waiver, shall report a positive SARS-CoV-2 test within three days of identification of evidence of disease. The report shall include the source of the specimen and the laboratory method and result; the name, telephone number, email address, address, age, date of birth, race, ethnicity, sex, and pregnancy status (if known) of the person from whom the specimen was obtained; and the name, address, and telephone number of the physician at whose request and medical facility at which the examination was made. A report shall be made by entering information into the department's available portal for laboratory reporting at https://www.vdh.virginia.gov/clinicians/disease-reporting-and-control-regulations/ or via electronic laboratory reporting at http://www.vdh.virginia.gov/meaningful-use/submissionofreportablelabresults.

History

• Statutory Authority: §§ 32.1-12 and 32.1-35 of the Code of Virginia.
• Historical Notes: Derived from VR355-28-100 § 3.1, eff. July 1, 1993; amended, Virginia Register Volume 15, Issue 6, eff. January 6, 1999; Volume 18, Issue 9, eff. December 18, 2001; Volume 20, Issue 21, eff. July 28, 2004; Volume 23, Issue 15, eff. May 2, 2007; Volume 25, Issue 11, eff. March 4, 2009; Errata, 25:12 VA.R. 2293 February 16, 2009; amended, Virginia Register Volume 27, Issue 13, eff. March 28, 2011; Volume 33, Issue 2, eff. October 20, 2016; Volume 34, Issue 7, eff. December 27, 2017; Errata, 34:8 VA.R. 831 December 11, 2017; amended, Virginia Register Volume 35, Issue 4, eff. November 14, 2018; Volume 39, Issue 9, eff. January 18, 2023; Volume 41, Issue 26, eff. September 10, 2025; Volume 42, Issue 1, eff. September 24, 2025.

12VAC5-90-90 Those required to report

A. A physician who treats or examines any person who is suffering from or who is suspected of having a reportable disease or condition shall report, at a minimum, that person's name, telephone number, address, age, date of birth, race, ethnicity, sex, and pregnancy status for females; name of disease diagnosed or suspected; the date of onset of illness; available laboratory tests and results; and the name, address, and telephone number of the physician and medical facility where the examination was made. A physician may designate someone to report on the physician's behalf, but the physician shall ensure that the appropriate report is made. A physician, designee, or organization making a report as authorized in this section shall be immune from liability as provided by § 32.1-38 of the Code of Virginia. The physician shall send the report within the timeframes specified in 12VAC5-90-80 to the local health department serving the jurisdiction in which the facility is located via the Virginia Department of Health's online Confidential Morbidity Report portal at https://www.vdh.virginia.gov/clinicians/disease-reporting-and-control-regulations/ or a CDC or VDH disease-specific surveillance form.

B. A laboratory director shall report a laboratory examination of a clinical specimen that yields evidence of a disease listed in 12VAC5-90-80 B. A laboratory director shall report results that are performed in-house or referred to a reference laboratory, with the following exception: if the laboratory director ascertains that the reference laboratory that tests a specimen reports to the department electronically, then the reference laboratory findings do not need to be reported by the laboratory of origin.

C. A report from a laboratory director shall give the source of the specimen and the laboratory method and result; the name, address, age, date of birth, race, ethnicity, sex, and pregnancy status for females (if known) of the person from whom the specimen was obtained; and the name, address, and telephone number of the physician at whose request and medical facility at which the examination was made. If the influenza virus is isolated, the type shall be reported, if available. A laboratory director shall make the report within the timeframes specified in 12VAC5-90-80 to the local health department serving the jurisdiction in which the laboratory is located via the department's online Confidential Morbidity Report portal or on the laboratory's own form, including a computer-generated report if it includes the required information. A laboratory director may make the required reports by means of secure electronic transmission upon agreement of the laboratory director and the department. A laboratory director shall submit a report of HIV genetic nucleotide sequence data associated with HIV drug resistance tests electronically. A person making a report as authorized in this section shall be immune from liability as provided by § 32.1-38 of the Code of Virginia.

D. If a clinical specimen yields evidence indicating the presence of a select agent or toxin as defined in 42 CFR Part 73, the laboratory director shall contact the Division of Consolidated Laboratory Services and arrange to forward an isolate for confirmation. If a select agent or toxin has been confirmed in a clinical specimen, the laboratory director shall consult with Division of Consolidated Laboratory Services or CDC regarding isolate transport or destruction.

E. A laboratory operating within a medical care facility shall be considered to be in compliance with the requirement to notify the local health department if the director of the medical care facility assumes the reporting responsibility; however, the laboratory director shall still submit isolates to the Division of Consolidated Laboratory Services or other designated laboratory as noted in 12VAC5-90-80 D unless the laboratory has submitted an exemption request that has been approved by the department.

F. A person in charge of a medical care facility shall make a report to the local health department serving the jurisdiction where the facility is located of the occurrence in or admission to the facility of a patient with a reportable disease listed in 12VAC5-90-80 A unless the person in charge of a medical care facility has evidence that the occurrence has been reported by a physician. A person making a report as authorized in this section shall be immune from liability as provided by § 32.1-38 of the Code of Virginia. The requirement to report shall include all inpatient, outpatient, and emergency care departments within the medical care facility. A report shall contain the patient's name, address, age, date of birth, race, ethnicity, sex, and, if the patient is female, pregnancy status; name of disease being reported; available laboratory tests and results; the date of admission; medical record number; date expired (if applicable); and attending physician. A report shall be made within the timeframes specified in 12VAC5-90-80 to the local health department serving the jurisdiction in which the facility is located via the Virginia Department of Health's online Confidential Morbidity Report portal at https://www.vdh.virginia.gov/clinicians/disease-reporting-and-control-regulations/ or a CDC or VDH disease-specific surveillance form. The person in charge of the medical facility may make the reports by means of secure electronic transmission upon agreement of the medical care facility and the department.

G. A person in charge of a medical care facility may assume the reporting responsibility on behalf of the director of the laboratory operating within the facility.

H. The person in charge of a residential or day program, service, or facility licensed or operated by any agency of the Commonwealth or a school, child care center, or summer camp as defined in § 35.1-1 of the Code of Virginia shall report immediately to the local health department the presence or suspected presence in the person in charge's program, service, facility, school, child care center, or summer camp of persons who have common symptoms suggesting an outbreak situation. The person in charge shall report additional information, including identifying and contact information for individuals with communicable diseases of public health concern or individuals who are involved in outbreaks that occur in the person in charge's facilities, as necessary to facilitate public health investigation and disease control. Identifying and contact information, at minimum, shall include a name and telephone number. A person making a report pursuant to this section shall be immune from liability as provided by § 32.1-38 of the Code of Virginia.

I. The local health director shall forward a report of a disease or report of evidence of a disease that has been made on a resident of the local health director's jurisdiction to the Office of Epidemiology within three days of receipt. The report shall be submitted immediately by the most rapid means available if the disease is one requiring rapid communication, as required in 12VAC5-90-80 C. Rapid reporting shall be confirmed in writing and submitted to the Office of Epidemiology, by either a paper report or entry into a shared secure electronic disease surveillance system, within three days. A local health director shall immediately forward to the appropriate local health director a disease report on an individual residing in the appropriate local health director's jurisdiction or to the Office of Epidemiology if the individual resides outside Virginia. The Office of Epidemiology shall notify other state health departments of reported illnesses in residents of the other state and shall notify CDC as necessary and appropriate.

J. In accordance with § 32.1-37.1 of the Code of Virginia, a person in charge of a hospital, nursing facility or nursing home, assisted living facility, or correctional facility shall, at the time of transferring custody of a dead body to a person practicing funeral services, notify the person practicing funeral services or the person practicing funeral services's agent if the dead person was known to have had, immediately prior to death, an infectious disease which may be transmitted through exposure to any bodily fluids. These include any of the following infectious diseases:

Coronavirus, severe (e.g., SARS-CoV, MERS-CoV)

Creutzfeldt-Jakob disease

Human immunodeficiency virus (HIV) infection

Hepatitis B (acute and chronic)

Hepatitis C (acute and chronic)

Rabies

Smallpox (Variola virus)

Syphilis, infectious (Treponema pallidum)

Tuberculosis, active disease (Mycobacterium tuberculosis complex)

Vaccinia, disease or adverse event

Viral hemorrhagic fever

K. Pursuant to 12VAC5-421-80, a food employee or conditional employee shall notify the person in charge of the food establishment when diagnosed with certain diseases that are transmissible through food, and the person in charge of the food establishment shall notify the department.

History

• Statutory Authority: §§ 32.1-12, 32.1-35, and 32.1-42 of the Code of Virginia.
• Historical Notes: Derived from VR355-28-100 § 3.2, eff. July 1, 1993; amended, Virginia Register Volume 15, Issue 6, eff. January 6, 1999; Errata, 15:8 VA.R. 1099 January 4, 1999; amended, Virginia Register Volume 20, Issue 21, eff. July 28, 2004; Volume 23, Issue 15, eff. May 2, 2007; Volume 27, Issue 13, eff. March 28, 2011; Volume 33, Issue 2, eff. October 20, 2016; Volume 36, Issue 6, eff. December 26, 2019; Volume 39, Issue 9, eff. January 18, 2023; Volume 41, Issue 26, eff. September 10, 2025.

Part IV Control of Disease

12VAC5-90-100 Methods

The board and commissioner shall use appropriate disease control measures to manage the diseases listed in 12VAC5-90-80 A, including but not limited to those described in the "Methods of Control" sections of the 20th Edition of the Control of Communicable Diseases Manual (2015) published by the American Public Health Association. The board and commissioner reserve the right to use any legal means to control any disease which is a threat to the public health.

When notified about a disease specified in 12VAC5-90-80, the local health director or his designee shall have the authority and responsibility to perform contact tracing/contact services for HIV infection, infectious syphilis, and active tuberculosis disease and may perform contact services for the other diseases if deemed necessary to protect the public health. All contacts of HIV infection shall be afforded the opportunity for appropriate counseling, testing, and individual face-to-face disclosure of their test results. In no case shall names of informants or infected individuals be revealed to contacts by the health department. All information obtained shall be kept strictly confidential.

The local health director or his designee shall review reports of diseases received from his jurisdiction and follow up such reports, when indicated, with an appropriate investigation in order to evaluate the severity of the problem. The local health director or his designee may recommend to any individual or group of individuals appropriate public health control measures, including but not limited to quarantine, isolation, immunization, decontamination, or treatment. He shall determine in consultation with the Office of Epidemiology and the commissioner if further investigation is required and if one or more forms of quarantine, isolation, or both will be necessary.

Complete isolation shall apply to situations where an individual is infected with a communicable disease of public health significance (including but not limited to active tuberculosis disease or HIV infection) and is engaging in behavior that places others at risk for infection with the communicable disease of public health significance, in accordance with the provisions of Article 3.01 (§ 32.1-48.01 et seq.) of Chapter 2 of Title 32.1 of the Code of Virginia.

Modified isolation shall apply to situations in which the local health director determines that modifications of activity are necessary to prevent disease transmission. Such situations shall include but are not limited to the temporary exclusion of a child with a communicable disease from school, the temporary exclusion of an individual with a communicable disease from food handling or patient care, the temporary prohibition or restriction of an individual with a communicable disease from using public transportation, the requirement that a person with a communicable disease use certain personal protective equipment, or restrictions of other activities that may pose a risk to the health of others.

Protective isolation shall apply to situations such as the exclusion, under § 32.1-47 of the Code of Virginia, of any unimmunized child from a school in which an outbreak, potential epidemic, or epidemic of a vaccine preventable disease has been identified.

To the extent permitted by the Code of Virginia, the local health director may be authorized as the commissioner's designee to implement the forms of isolation described in this section. When these forms of isolation are deemed to be insufficient, the local health director may use the provisions of Article 3.01 (§ 32.1-48.01 et seq.) of Chapter 2 of Title 32.1 of the Code of Virginia for the control of communicable diseases of public health significance or, in consultation with the Office of Epidemiology, shall provide sufficient information to enable the commissioner to prepare an order or orders of isolation, quarantine, or both under Article 3.02 (§ 32.1-48.05 et seq.) of Chapter 2 of Title 32.1 of the Code of Virginia for the control of communicable diseases of public health threat.

History

• Statutory Authority: § 32.1-35 of the Code of Virginia.
• Historical Notes: Derived from VR355-28-100 § 4.1, eff. July 1, 1993; amended, Virginia Register Volume 15, Issue 6, eff. January 6, 1999; Volume 20, Issue 21, eff. July 28, 2004; Volume 23, Issue 15, eff. May 2, 2007; Volume 27, Issue 13, eff. March 28, 2011; Volume 33, Issue 2, eff. October 20, 2016.

12VAC5-90-103 Isolation for communicable disease of public health threat

A. The commissioner, in the commissioner's sole discretion, may invoke the provisions of Article 3.02 (§ 32.1-48.05 et seq.) of Chapter 2 of Title 32.1 of the Code of Virginia and may declare the isolation of any individual upon a determination that:

1. The individual is known to have been infected with or is reasonably suspected to have been infected with a communicable disease of public health threat;

2. Exceptional circumstances render the procedures of Article 3.01 (§ 32.1-48.01 et seq.) of Chapter 2 of Title 32.1 of the Code of Virginia to be insufficient, or the individual has failed or refused to comply voluntarily with the control measures directed by the commissioner in response to a communicable disease of public health threat; and

3. Isolation is the necessary means to contain a communicable disease of public health threat, to ensure that the isolated individual receives appropriate medical treatment subject to the provisions of § 32.1-44 of the Code of Virginia, or to protect health care providers and others who may come into contact with the infected individual.

The commissioner, in the commissioner's sole discretion, may also order the isolation of an affected area if, in addition to the provisions of this subsection, the Governor has declared a state of emergency for such affected area of the Commonwealth.

B. For isolation for a communicable disease of public health threat, the local health department shall record information about the infection or suspected infection, the individual or affected area, and the nature or suspected nature of the exposure in consultation with the Office of Epidemiology. This information shall be sufficient to enable documenting a record of findings and to enable the commissioner to prepare the order of isolation, including the information required in § 32.1-48.12 of the Code of Virginia. In addition, the local health department shall maintain sufficient information on individuals to enable appropriate follow-up of individuals for health status evaluation and treatment as well as compliance with the order of isolation. The commissioner shall ensure that the protected health information of an individual subject to the order of isolation is disclosed only in compliance with state and federal law.

C. The local health department shall assess the situation, and in consultation with the Office of Epidemiology, identify the least restrictive means of isolation that effectively protects unexposed and susceptible individuals. The place of isolation selected shall allow the most freedom of movement and communication with family members and other contacts without allowing disease transmission to other individuals and shall allow the appropriate level of medical care needed by isolated individuals to the extent practicable. The commissioner, in the commissioner's sole discretion, may order an isolated individual to remain in the individual's residence, to remain in another place where the individual is present, or to report to a place designated by the commissioner for the duration of the isolation.

D. The commissioner's order of isolation shall be for a duration consistent with the known period of communicability of the communicable disease of public health threat or, if the course of the disease is unknown or uncertain, for a period anticipated as being consistent with the period of communicability of other similar infectious agents. In the situation where an area is under isolation, the duration of isolation shall take into account the transmission characteristics and known or suspected period of communicability.

E. The local health department shall deliver the order of isolation or ensure its delivery by an appropriate party, such as a law-enforcement officer or health department employee, to the affected individual in person to the extent practicable. If, in the opinion of the commissioner, the scope of the notification would exceed the capacity of the local health department to ensure individual notification in a timely manner, then print, radio, television, Internet, or other available means shall be used to inform those affected.

F. For an individual identified as, or for whom probable cause exists that the individual may be, in violation of an order of isolation, or for whom probable cause exists that the individual may fail or refuse to comply with the order, the enforcement authority directed by the commissioner to law-enforcement agencies shall include the power to detain or arrest.

An individual so detained shall be held in the least restrictive environment that can provide any required health care or other services for such individual. The commissioner shall ensure that law-enforcement personnel responsible for enforcing an order of isolation are informed of appropriate measures to take to protect themselves from contracting the disease of public health threat.

G. The local health department shall monitor the health of those under isolation either by regular telephone calls, visits, self-reports, or by reports of caregivers or health care providers or by other means.

H. Upon issuance of an order of isolation to an individual by the commissioner, the local health department shall manage the isolation, in conjunction with local emergency management resources, such that the individual's essential needs can be met to the extent practicable. Upon issuance of an order of isolation by the commissioner for an affected area, existing emergency protocols pursuant to Chapter 3.2 (§ 44-146.13 et seq.) of Title 44 of the Code of Virginia shall be utilized for mobilizing appropriate resources to ensure essential needs are met.

I. An individual subject to an order of isolation or a court-ordered confirmation or extension of the order may file an appeal of the order of isolation in accordance with the provisions of § 32.1-48.13 of the Code of Virginia. An appeal shall not stay any order of isolation.

J. Once the commissioner determines that individuals no longer pose a threat to the public health, the order of isolation has expired, or the order of isolation has been vacated by the court, the individuals under the order of isolation shall be released immediately. If the risk of an infected individual transmitting the communicable disease of public health threat to other individuals continues to exist, an order of isolation may be developed to extend the restriction prior to release from isolation.

K. If the criteria in subsection A of this section are met and an area is known or suspected to have been affected, then the commissioner shall notify the Governor of the situation and the need to order isolation for the affected area during the known or suspected time of exposure. In order for an affected area to be isolated, the Governor must declare a state of emergency for the affected area.

L. If an order of isolation is issued for an affected area during the known or suspected time of exposure, the commissioner shall cause the order of isolation to be communicated to the individuals residing or located in the affected area. The use of multiple forms of communication, including radio, television, Internet, or other available means, may be required in order to reach the individuals who were in the affected area during the known or suspected time of exposure.

M. The provisions for documentation, means of isolation, enforcement, health status monitoring, essential needs, and release from isolation as described in this section apply to the isolation of affected areas. Appropriate management of a disease of public health threat for an affected area may require the coordinated use of local, regional, state, and national resources. In specifying one or more affected areas to be placed under isolation, the commissioner shall maintain the objective to protect as many people as possible using the least restrictive means. As a result, defining the precise boundaries and timeframe of the exposure may not be possible or may change as additional information becomes available. If this occurs, the commissioner shall ensure that the description of the affected area is in congruence with the Governor's declaration of emergency and shall ensure that the latest information is communicated to those in or exposed to the affected area.

History

• Statutory Authority: §§ 32.1-12, 32.1-35, and 32.1-42 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 15, eff. May 2, 2007; amended, Virginia Register Volume 27, Issue 13, eff. March 28, 2011; Volume 36, Issue 6, eff. December 26, 2019; Volume 41, Issue 26, eff. September 10, 2025.

12VAC5-90-107 Quarantine

A. The commissioner, in the commissioner's sole discretion, may invoke the provisions of Article 3.02 (§ 32.1-48.05 et seq.) of Chapter 2 of Title 32.1 of the Code of Virginia and may order a complete or modified quarantine of an individual upon a determination that:

1. The individual is known to have been exposed to or is reasonably suspected to have been exposed to a communicable disease of public health threat;

2. Exceptional circumstances render the procedures of Article 3.01 (§ 32.1-48.01 et seq.) of Chapter 2 of Title 32.1 of the Code of Virginia to be insufficient, or the individual has failed or refused to comply voluntarily with the control measures directed by the commissioner in response to a communicable disease of public health threat; and

3. Quarantine is the necessary means to contain a communicable disease of public health threat to which an individual has been or may have been exposed and thus may become infected.

The commissioner, in the commissioner's sole discretion, may also order the quarantine of an affected area if, in addition to the provisions of this subsection, the Governor has declared a state of emergency for such affected area of the Commonwealth.

B. For quarantine for a communicable disease of public health threat, the local health department shall record information about the infection or suspected infection; the individual or affected area; and the nature or suspected nature of the exposure in consultation with the Office of Epidemiology. This information shall be sufficient to enable documenting a record of findings and enable the commissioner to prepare a written order of quarantine, including the information required in § 32.1-48.09 of the Code of Virginia. In addition, the local health department shall maintain sufficient information on individuals to enable appropriate follow-up of individuals for health status evaluation and treatment as well as compliance with the order of quarantine. The commissioner shall ensure that the protected health information of any individual subject to the order of quarantine is disclosed only in compliance with state and federal law.

C. The local health department shall assess the situation and, in consultation with the Office of Epidemiology, shall recommend to the commissioner the least restrictive means of quarantine that effectively protects unexposed and susceptible individuals. The place of quarantine selected shall allow the most freedom of movement and communication with family members and other contacts without allowing disease transmission to others. The commissioner, in the commissioner's sole discretion, may order the quarantined individuals to remain in their residences, to remain in another place where they are present, or to report to a place designated by the commissioner for the duration of their quarantine.

D. The commissioner's order of quarantine shall be for a duration consistent with the known incubation period of the communicable disease of public health threat or, if the incubation period is unknown or uncertain, for a period anticipated as being consistent with the incubation period for other similar infectious agents. If an area is under quarantine, the duration of quarantine shall take into account the transmission characteristics and known or suspected incubation period.

E. The local health department shall deliver the order of quarantine or ensure its delivery by an appropriate party, such as a law-enforcement officer or health department employee, to the affected individual in person to the extent practicable. If, in the opinion of the commissioner, the scope of the notification would exceed the capacity of the local health department to ensure notification in a timely manner, then print, radio, television, Internet, or other available means shall be used to inform those affected.

F. For an individual identified as, or for whom probable cause exists that the individual may be, in violation of an order of quarantine, or for whom probable cause exists that the individual may fail or refuse to comply with an order, the enforcement authority directed by the commissioner to law-enforcement agencies shall include the power to detain or arrest.

An individual so detained shall be held in the least restrictive environment that can provide any required health care or other services for such individual. The commissioner shall ensure that law-enforcement personnel responsible for enforcing an order of quarantine are informed of appropriate measures to take to protect themselves from contracting the disease of public health threat.

G. The local health department shall monitor the health of individuals under quarantine either by regular telephone calls, visits, self-reports, or by reports of caregivers or health care providers or by other means. If individuals develop symptoms compatible with the communicable disease of public health threat, then 12VAC5-90-103 would apply to the individuals.

H. Upon issuance of an order of quarantine to an individual by the commissioner, the local health department shall manage the quarantine, in conjunction with local emergency management resources, such that the individual's essential needs can be met to the extent practicable. Upon issuance of an order of quarantine by the commissioner for an affected area, existing emergency protocols pursuant to Chapter 3.2 (§ 44-146.13 et seq.) of Title 44 of the Code of Virginia shall be utilized for mobilizing appropriate resources to ensure essential needs are met.

I. An individual subject to an order of quarantine or a court-ordered confirmation or extension of an order may file an appeal of the order of quarantine in accordance with the provisions of § 32.1-48.10 of the Code of Virginia. An appeal shall not stay any order of quarantine.

J. Once the commissioner determines that individuals are no longer at risk of becoming infected and pose no risk of transmitting the communicable disease of public health threat to other individuals, the order of quarantine has expired, or the order of quarantine has been vacated by the court, the individuals under the order of quarantine shall be released immediately. If the risk of an individual becoming infected and transmitting the communicable disease of public health threat to other individuals continues to exist, an order of quarantine may be developed to extend the restriction prior to release from quarantine.

K. If the criteria in subsection A of this section are met and an area is known or suspected to have been affected, then the commissioner shall notify the Governor of the situation and the need to order quarantine for the affected area. In order for an affected area to be quarantined, the Governor must declare a state of emergency for the affected area.

L. If an order of quarantine is issued for an affected area, the commissioner shall cause the order of quarantine to be communicated to the individuals residing or located in the affected area. The use of multiple forms of communication, including radio, television, Internet, or other available means, may be required in order to reach the individuals who were in the affected area during the known or suspected time of exposure.

M. The provisions for documentation, means of quarantine, enforcement, health status monitoring, essential needs, and release from quarantine as described in this section apply to the quarantine of affected areas. Appropriate management of a disease of public health threat for an affected area may require the coordinated use of local, regional, state, and national resources. In specifying one or more affected areas to be placed under quarantine, the commissioner shall maintain the objective to protect as many people as possible using the least restrictive means. As a result, defining the precise boundaries and timeframe of the exposure may not be possible or may change as additional information becomes available. If this occurs, the commissioner shall ensure that the description of the affected area is in congruence with the Governor's declaration of emergency and shall ensure that the latest information is communicated to those in or exposed to the affected area.

History

• Statutory Authority: §§ 32.1-12, 32.1-35, and 32.1-42 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 15, eff. May 2, 2007; amended, Virginia Register Volume 27, Issue 13, eff. March 28, 2011; Volume 36, Issue 6, eff. December 26, 2019; Volume 41, Issue 26, eff. September 10, 2025.

Part V Immunization of Persons Less Than 18 Years of Age

12VAC5-90-110 Dosage and age requirements for immunizations; obtaining immunizations

A. Every person in Virginia less than 18 years of age shall be immunized in accordance with the most recent Immunization Schedule developed and published by the CDC, Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP). Requirements for school and day care attendance are addressed in 12VAC5-110.

B. The required immunizations may be obtained from a physician, registered nurse, or other licensed professional as authorized by the Code of Virginia.

History

• Statutory Authority: § 32.1-35 of the Code of Virginia.
• Historical Notes: Derived from VR355-28-100 § 5.1, eff. July 1, 1993; amended, Virginia Register Volume 15, Issue 6, eff. January 6, 1999; Volume 20, Issue 21, eff. July 28, 2004; Volume 23, Issue 15, eff. May 2, 2007; Volume 27, Issue 13, eff. March 28, 2011; Volume 33, Issue 2, eff. October 20, 2016.

12VAC5-90-120 (Repealed.)

Historical Notes

Derived from VR355-28-100 § 5.2, eff. July 1, 1993; repealed, Virginia Register Volume 15, Issue 6, eff. January 6, 1999.

Part VI Venereal Disease

12VAC5-90-130 Prenatal testing

Every physician, physician assistant, or nurse practitioner attending a pregnant patient during gestation shall examine and test such patient for syphilis, hepatitis B surface antigen (HBsAg), and any other sexually transmitted disease as clinically indicated within 15 days after beginning such attendance. A second prenatal test for syphilis and HBsAg shall be conducted at the beginning of the third trimester (28 weeks) for patients who are at higher risk for these diseases. Persons at higher risk for syphilis include those who have had multiple sexual partners within the previous year, those with any prior history of a sexually transmitted disease, and those living in communities and populations in which the prevalence of syphilis is high. Persons at higher risk for hepatitis B virus infection include injecting drug users and those with personal contact with a hepatitis B patient, multiple sexual partners, and/or occupational exposure to blood. If the patient first seeks care during the third trimester, only one test shall be required. As a routine component of prenatal care, every licensed practitioner who renders prenatal care, including any holder of a multistate licensure privilege to practice nursing, regardless of the site of such practice, shall inform every pregnant patient that human immunodeficiency virus (HIV) screening is recommended for all pregnant patients and that she will receive an HIV test as part of the routine panel of prenatal tests unless she declines (opt-out screening). The practitioner shall offer the pregnant patient oral or written information that includes an explanation of HIV infection, a description of interventions that can reduce HIV transmission from mother to infant, and the meaning of positive and negative test results. The confidentiality provisions of § 32.1-36.1 of the Code of Virginia and the test result disclosure conditions and appropriate counseling requirements of § 32.1-37.2 of the Code of Virginia shall apply to any HIV testing conducted pursuant to this section. The Centers for Disease Control and Prevention (CDC) recommends a second HIV test for patients who receive health care in jurisdictions with elevated incidence of HIV or AIDS among women aged 15 through 45 years, which includes Virginia. Practitioners should offer a second HIV test during the third trimester to all pregnant patients. Practitioners shall counsel all pregnant patients with HIV-positive test results about the dangers to the fetus and the advisability of receiving treatment in accordance with the then current CDC recommendations for HIV-positive pregnant patients. Any pregnant patient shall have the right to refuse testing for HIV infection and any recommended treatment. Documentation of such refusal shall be maintained in the patient's medical record.

History

• Statutory Authority: § 32.1-35 of the Code of Virginia.
• Historical Notes: Derived from VR355-28-100 § 6.1, eff. July 1, 1993; amended, Virginia Register Volume 15, Issue 6, eff. January 6, 1999; Volume 23, Issue 15, eff. May 2, 2007; Volume 27, Issue 13, eff. March 28, 2011.

Part VII Prevention of Blindness from Ophthalmia Neonatorum

12VAC5-90-140 Procedure for preventing ophthalmia neonatorum

The physician, nurse, or midwife in charge of the infant's care after delivery of a baby shall ensure that a 1-cm ribbon of 0.5% erythromycin ophthalmic ointment is administered in each eye of the infant as soon as possible after birth and shall record the treatment in the medical record of the infant.

History

• Statutory Authority: §§ 32.1-12, 32.1-35, and 32.1-42 of the Code of Virginia.
• Historical Notes: Derived from VR355-28-100 § 7.1, eff. July 1, 1993; amended, Virginia Register Volume 27, Issue 13, eff. March 28, 2011; Volume 36, Issue 6, eff. December 26, 2019; Volume 41, Issue 26, eff. September 10, 2025.

Part VIII Cancer Reporting

12VAC5-90-150 Authority

Article 9 (§ 32.1-70 et seq.) of Title 32.1 of the Code of Virginia authorizes the establishment of a statewide cancer registry.

History

• Statutory Authority: §§ 32.1-12 and 32.1-35 of the Code of Virginia.
• Historical Notes: Derived from VR355-28-100 § 8.1, eff. July 1, 1993; amended, Virginia Register Volume 15, Issue 6, eff. January 6, 1999.

12VAC5-90-160 Reportable cancers and tumors

Clinically or pathologically diagnosed cancers, as defined in 12VAC5-90-10, and benign brain and central nervous system tumors shall be reported to the Virginia Cancer Registry in the department. Carcinoma in situ of the cervix is not reportable.

History

• Statutory Authority: §§ 32.1-12 and 32.1-35 of the Code of Virginia.
• Historical Notes: Derived from VR355-28-100 § 8.2, eff. July 1, 1993; amended, Virginia Register Volume 15, Issue 6, eff. January 6, 1999; Volume 20, Issue 21, eff. July 28, 2004.

12VAC5-90-170 Those required to report

Any person in charge of a medical care facility, clinic, or independent pathology laboratory which diagnoses or treats cancer patients is required to report. Physicians are required to report cases of cancer in those instances when it has been determined that a medical care facility, clinic, or instate pathology laboratory has not reported. Any person making such report shall be immune from liability as provided by § 32.1-38 of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-35 of the Code of Virginia.
• Historical Notes: Derived from VR355-28-100 § 8.3, eff. July 1, 1993; amended, Virginia Register Volume 15, Issue 6, eff. January 6, 1999.

12VAC5-90-180 Report contents and procedures

Each report shall include the patient's name, address (including county or independent city of residence), age, date of birth, sex, date of diagnosis, date of admission or first contact, primary site of cancer, histology (including type, behavior, and grade), basis of diagnosis, social security number, race, ethnicity, marital status, usual occupation, usual industry, sequence number, laterality, stage, treatment, recurrence information (when applicable), name of reporting facility, vital status, cause of death (when applicable), date of last contact, history of tobacco and alcohol use, and history of service in Vietnam and exposure to dioxin-containing compounds, when applicable.

Reporting shall be by electronic means where possible. Output file formats shall conform to the most recent version of the North American Association of Central Cancer Registries' standard data file layout. Facilities without electronic reporting means and physicians shall submit the required information on the Virginia Cancer Registry Reporting Form. A copy of the pathology report(s) should accompany each completed reporting form, when available. Medical care facilities and clinics reporting via the reporting form should also submit a copy of the admission form and discharge summary.

Reports shall be made within six months of the diagnosis of cancer and submitted to the Virginia Cancer Registry on a monthly basis. Cancer programs conducting annual follow-up on patients shall submit follow-up data monthly in an electronic format approved by the Virginia Cancer Registry.

History

• Statutory Authority: §§ 32.1-12 and 32.1-35 of the Code of Virginia.
• Historical Notes: Derived from VR355-28-100 § 8.4, eff. July 1, 1993; amended, Virginia Register Volume 15, Issue 6, eff. January 6, 1999; Volume 20, Issue 21, eff. July 28, 2004.

12VAC5-90-190 (Repealed.)

Historical Notes

Derived from VR355-28-100 § 8.5, eff. July 1, 1993; repealed, Virginia Register Volume 15, Issue 6, eff. January 6, 1999.

Part IX Reporting and Control of Diseases

12VAC5-90-200 Reporting and control of diseases

Chapter 2 (§ 32.1-35 et seq.) of Title 32.1 of the Code of Virginia relating to the Reporting and Control of Diseases is incorporated by reference and made a part of these regulations.

History

• Statutory Authority: §§ 32.1-12 and 32.1-35 of the Code of Virginia.
• Historical Notes: Derived from VR355-28-100 § 9.1, eff. July 1, 1993.

12VAC5-90-210 (Repealed.)

Historical Notes

Derived from VR355-28-100 §§ 10.1 and 10.2, eff. July 1, 1993; repealed, Virginia Register Volume 15, Issue 6, eff. January 6, 1999.

Part X Protocol for Identification of Children with Elevated Blood Lead Levels

12VAC5-90-215 Schedule and criteria for and confirmation of blood lead testing and information to be provided

A. A child shall be tested to determine the blood lead level at 12 months and 24 months of age if the health care provider determines that the child meets any of the criteria listed in subsection B of this section. A child 25 months through 72 months of age who presents for medical care and meets any of the criteria of subsection B of this section shall also be tested if the child has either not previously been tested for blood lead level or was previously tested but experienced a change since testing that has resulted in an increased risk of lead exposure based on the criteria listed in subsection B of this section.

B. The criteria for blood lead testing are as follows:

1. The child is eligible for or receiving benefits from Medicaid or the Special Supplemental Nutrition Program for Women, Infants and Children (WIC);

2. The child is living in or regularly visiting a house, apartment, dwelling, structure, or child care facility built before 1950;

3. The child is living in or regularly visiting a house, apartment, dwelling, structure, or child care facility built before 1978 that has(i)peeling or chipping paint or (ii)recent (within the last six months) ongoing or planned renovations;

4. The child is living in or regularly visiting a house, apartment, dwelling, or other structure in which one or more persons have blood lead testing yielding evidence of lead exposure;

5. The child is living with an adult whose job, hobby, or other activity involves exposure to lead;

6. The child is living near an active lead smelter, battery recycling plant, or other industry likely to release lead;

7. The child's parent, guardian, or other person standing in loco parentis requests the child's blood be tested due to any suspected exposure; or

8. The child is a recent refugee or immigrant or is adopted from outside of the United States.

C. A child who does not meet any of the schedule or criteria provided in subsection A or B of this section is considered to be at low risk, and testing is not required but may be conducted at the discretion of the health care provider. The testing requirement shall be waived if the parent, guardian, or other person standing in loco parentis of the child objects to the testing on the basis that the procedure conflicts with his religious tenets or practices.

D. Blood lead level testing shall be performed on venous or capillary blood. Tests of venous blood performed by a laboratory certified by the federal Centers for Medicare & Medicaid Services in accordance with 42 USC § 263a, the Clinical Laboratory Improvement Amendment of 1988 (CLIA-certified), are considered confirmatory. Tests of venous blood performed by any other laboratory and tests of capillary blood shall be confirmed by a repeat blood test, preferably venous, performed by a CLIA-certified laboratory. Confirmatory testing is not required if the result of the capillary test is below the CDC reference value. Confirmatory testing shall be performed:

1. Within one to three months if the result of the capillary test is at or above the CDC reference value and up to nine micrograms of lead per deciliter of whole blood (µg/dL);

2. Within one week to one month if the result of the capillary test is 10-44 µg/dL. The higher this test result, the more urgent the need for a confirmatory test is;

3. Within 48 hours if the result of the capillary test is 45-59 µg/dL;

4. Within 24 hours if the result of the capillary test is 60-69 µg/dL; and

5. Immediately as an emergency laboratory test if the result of the capillary test is 70 µg/dL or higher.

E. As part of regular well-check visits for all children, the health care provider shall make available to parents, guardians, or other persons standing in loco parentis information on the dangers of lead poisoning, potential sources of lead and ways to prevent exposure, and a list of available lead-related resources. When blood lead level testing is performed, the health care provider shall share the child's blood lead level test result with the child's parent, guardian, or other person standing in loco parentis and shall report to the local health department in accordance with the requirements of 12VAC5-90-80.

History

• Statutory Authority: §§ 32.1-12, 32.1-35, and 32.1-42 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 12, eff. March 11, 2016; amended, Virginia Register Volume 36, Issue 6, eff. December 26, 2019; Volume 41, Issue 26, eff. September 10, 2025.

12VAC5-90-220 (Repealed.)

Historical Notes

Derived from VR355-28-100 §§ 10.1 and 10.2, eff. July 1, 1993; repealed, Virginia Register Volume 15, Issue 6, eff. January 6, 1999.

Part XI Tuberculosis Control

12VAC5-90-225 Additional data to be reported related to persons with active tuberculosis disease (confirmed or suspected)

A. Physicians and directors of medical care facilities shall submit the following to the department:

1. An initial report to be completed when there are reasonable grounds to suspect that a person has active TB disease, but no later than when antituberculosis drug therapy is initiated. The report shall include the following: the affected person's name; age; date of birth; gender; address; pertinent clinical, radiographic, microbiologic, and pathologic reports, whether pending or final; other information as may be needed to locate the patient for follow-up; and name, address, and telephone number of the treating physician.

2. A secondary report to be completed simultaneously or within one to two weeks following the initial report. The report shall include: the date, method, and results of tests for tuberculosis infection; the date and results of the initial and follow-up chest radiographs; the dates and results of bacteriologic or pathologic testing, the antituberculosis drug regimen, including names of the drugs, dosages and frequencies of administration, and start date; the date and results of drug susceptibility testing; HIV status; contact screening information; and name, address, and telephone number of treating physician.

3. Subsequent reports when updated information is available. Subsequent reports are required when clinical status changes, the treatment regimen changes; treatment ceases for any reason; or there are any updates to laboratory results, treatment adherence, name, address, and telephone number of current provider, patient location or contact information, or other additional clinical information.

B. Physicians or directors of medical care facilities responsible for the care of a patient with active tuberculosis disease shall develop and maintain a written treatment plan that shall be in place no later than the time when antituberculosis drug therapy is initiated. Patient adherence to this treatment plan must be documented. The treatment plan and adherence record are subject to review by the local health director or the local health director's designee at any time during the course of treatment.

C. The treatment plan for the following categories of patients shall be submitted to the local health director or the local health director's designee for approval no later than the time when antituberculosis drug therapy is started or modified:

1. Individuals who are inpatients or incarcerated, for whom the responsible provider or facility shall submit the treatment plan for approval prior to discharge or transfer.

2. Individuals, whether inpatient, incarcerated, or outpatient, who also have one of the following conditions:

a. HIV infection;

b. Known or suspected active TB disease resistant to rifampin, rifabutin, rifapentine, or other rifamycin with or without resistance to any other drug;

c. A history of prior treated or untreated active TB disease, or a history of relapsed active TB disease; or

d. A demonstrated history of nonadherence to any medical treatment regimen.

D. A laboratory director shall submit the following:

1. Results of smears that are positive for acid fast bacilli;

2. Results of cultures positive for any member of the Mycobacterium tuberculosis complex or any other mycobacteria;

3. Results of rapid methodologies, including acid hybridization or nucleic acid amplification, which are indicative of M. tuberculosis complex or any other mycobacteria;

4. Results of tests for antimicrobial susceptibility performed on cultures positive for M. tuberculosis complex; and

5. Results of tests for tuberculosis infection.

Whether testing is done in-house or referred to an out-of-state laboratory, a laboratory director shall submit a representative and viable sample of the initial culture positive for any member of the M. tuberculosis complex to the Division of Consolidated Laboratory Services or other laboratory designated by the board to receive such specimen.

History

• Statutory Authority: §§ 32.1-12, 32.1-35, and 32.1-42 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 20, Issue 21, eff. July 28, 2004; amended, Virginia Register Volume 23, Issue 15, eff. May 2, 2007; Volume 27, Issue 13, eff. March 28, 2011; Volume 36, Issue 6, eff. December 26, 2019; Volume 41, Issue 26, eff. September 10, 2025.

Part XII (Repealed)

12VAC5-90-230 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 14, Issue 26, eff. October 14, 1998; repealed, Virginia Register Volume 34, Issue 8, eff. January 26, 2018.

12VAC5-90-240 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 14, Issue 26, eff. October 14, 1998; repealed, Virginia Register Volume 34, Issue 8, eff. January 26, 2018.

12VAC5-90-250 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 14, Issue 26, eff. October 14, 1998; amended, Virginia Register Volume 23, Issue 15, eff. May 2, 2007; repealed, Virginia Register Volume 34, Issue 8, eff. January 26, 2018.

12VAC5-90-260 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 14, Issue 26, eff. October 14, 1998; amended, Virginia Register Volume 23, Issue 15, eff. May 2, 2007; repealed, Virginia Register Volume 34, Issue 8, eff. January 26, 2018.

12VAC5-90-270 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 14, Issue 26, eff. October 14, 1998; amended, Virginia Register Volume 23, Issue 15, eff. May 2, 2007; repealed, Virginia Register Volume 34, Issue 8, eff. January 26, 2018.

Part XIII Reporting of Dangerous Microbes and Pathogens

12VAC5-90-280 Reporting of dangerous microbes and pathogens

A. Definitions. The following term when used in this part shall have the following meaning unless the context clearly indicates otherwise:

"Select agent or toxin" or "select agent and toxin" means all those biological agents or toxins as defined by federal regulations in 42 CFR Part 73, including Health and Human Services select agents and toxins and overlap select agents and toxins. "Dangerous microbes and pathogens" will be known as "select agents and toxins."

B. Items to report. Each report shall contain the following: name, source, and characterization information on select agents and toxins and quantities held and the name and address of the laboratory and the name, position, and identification information of one responsible official as a single point of contact for the organization.

C. Timing of reports. By January 31 of every year, the responsible official at a laboratory as designated by the Federal Select Agent Program shall provide a written report to the Division of Surveillance and Investigation in the Office of Epidemiology containing the information specified in subsection B of this section.

In the event of a suspected release, loss, or theft of any select agent or toxin, the responsible official at a laboratory as designated by the Federal Select Agent Program shall make a report to the department immediately by the most rapid means available, preferably by telephone. The report shall be submitted to the Division of Surveillance and Investigation in the Office of Epidemiology. The rapid report shall be followed up by a written report within seven calendar days and shall include the following information:

1. The name of the biologic agent and any identifying information (e.g., strain or other characterization information);

2. An estimate of the quantity released, lost, or stolen;

3. An estimate of the time during which the release, loss, or theft occurred;

4. The location (building, room) from or in which the release, loss, or theft occurred. The report may contain additional information as required by 42 CFR Part 73 or the department; and

5. If a release has occurred, the report shall also include the nature, environment, and location of the release; number, names, and position of exposed individuals; and actions taken as a result of the release.

D. Release of reported information. Reports submitted to the select agent and toxin registry shall be confidential and shall not be a public record pursuant to the Freedom of Information Act, regardless of submitter. Release of information on select agents or toxins shall be made only by order of the State Health Commissioner to the CDC and state and federal law-enforcement agencies in any investigation involving the release, theft, or loss of a select agent or toxin required to be reported to the department under this regulation. A person making a report as authorized in this section shall be immune from liability as provided by § 32.1-38 of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12, 32.1-35, and 32.1-42 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 20, Issue 21, eff. July 28, 2004; amended, Virginia Register Volume 23, Issue 15, eff. May 2, 2007; Volume 33, Issue 2, eff. October 20, 2016; Volume 36, Issue 6, eff. December 26, 2019; Volume 41, Issue 26, eff. September 10, 2025.

12VAC5-90-290 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 20, Issue 21, eff. July 28, 2004; repealed, Virginia Register Volume 33, Issue 2, eff. October 20, 2016.

12VAC5-90-300 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 20, Issue 21, eff. July 28, 2004; repealed, Virginia Register Volume 33, Issue 2, eff. October 20, 2016.

12VAC5-90-310 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 20, Issue 21, eff. July 28, 2004; repealed, Virginia Register Volume 33, Issue 2, eff. October 20, 2016.

12VAC5-90-320 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 20, Issue 21, eff. July 28, 2004; repealed, Virginia Register Volume 33, Issue 2, eff. October 20, 2016.

12VAC5-90-330 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 20, Issue 21, eff. July 28, 2004; amended, Virginia Register Volume 23, Issue 15, eff. May 2, 2007; repealed, Virginia Register Volume 33, Issue 2, eff. October 20, 2016.

12VAC5-90-340 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 20, Issue 21, eff. July 28, 2004; repealed, Virginia Register Volume 33, Issue 2, eff. October 20, 2016.

12VAC5-90-350 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 20, Issue 21, eff. July 28, 2004; amended, Virginia Register Volume 23, Issue 15, eff. May 2, 2007; repealed, Virginia Register Volume 33, Issue 2, eff. October 20, 2016.

12VAC5-90-360 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 20, Issue 21, eff. July 28, 2004; amended, Virginia Register Volume 23, Issue 15, eff. May 2, 2007; repealed, Virginia Register Volume 33, Issue 2, eff. October 20, 2016.

Part XIV Reporting of Healthcare-Associated Infections

12VAC5-90-370 Reporting of health care-associated infections

A. A health care facility that reports data into the Centers for Disease Control and Prevention's National Healthcare Safety Network (NHSN) as a requirement of the Centers for Medicare and Medicaid Services shall share the data, through the NHSN, with the department.

B. A person making a report as authorized in this section shall be immune from liability as provided by § 32.1-38 of the Code of Virginia. Infection rate data may be released to the public by the department upon request. Data shall be aggregated to ensure that no individual patient may be identified.

History

• Statutory Authority: §§ 32.1-12 , 32.1-35, and 32.1-42 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. July 1, 2008; amended, Virginia Register Volume 27, Issue 13, eff. March 28, 2011; Volume 31, Issue 26, eff. September 25, 2015; Volume 36, Issue 6, eff. December 26, 2019; Volume 41, Issue 26, eff. September 10, 2025.

Chapter 110 Regulations for the Immunization of School Children

Part I Definitions

12VAC5-110-10 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Adequate immunization" or "adequately immunized" means the immunization requirements prescribed under 12VAC5-110-70.

"Admit" or "admission" means the official enrollment or reenrollment for attendance at any grade level, whether full-time or part-time, of any student by any school.

"Admitting official" means the school principal or the principal's designated representative if a public school; if a nonpublic school or child care center, the principal, headmaster, or director of the school or center.

"Board" means the State Board of Health.

"Commissioner" means the State Health Commissioner.

"Compliance" means the completion of the immunization requirements prescribed under 12VAC5-110-70.

"Conditional enrollment" means the enrollment of a student for a period of 90 days contingent upon the student having received at least one dose of each of the required vaccines and the student possessing a plan, from a physician or local health department, for completing immunization requirements within the ensuing 90 calendar days. If the student requires more than two doses of hepatitis B vaccine, the conditional enrollment period, for hepatitis B vaccine only, shall be 180 calendar days.

"Documentary proof" means an appropriately completed copy of the most current version of Form MCH 213G signed by a physician or the physician's designee, registered nurse, or an official of a local health department. A copy of the immunization record signed or stamped by a physician or the physician's designee, registered nurse, or an official of a local health department indicating the dates of administration including month, day, and year of the required vaccines, shall be acceptable in lieu of recording these dates on Form MCH 213G, as long as the record is attached to Form MCH 213G and the remainder of Form MCH 213G has been appropriately completed. A printout of an immunization record from the provider's electronic health record can be accepted without a signature or stamp. For a new student transferring from an out-of-state school, any immunization record that contains the exact date (month/day/year) of administration of each of the required doses of vaccines, is signed by a physician or the physician's designee or registered nurse, and complies fully with the requirements prescribed under 12VAC5-110-70 shall be acceptable.

"Immunization" means the administration of a product licensed by the FDA to confer protection against one or more specific pathogens.

"Immunization schedule" means the 2022 Recommended Immunization Schedules for Children and Adolescents Aged 18 Years or Younger developed and published by the Centers for Disease Control and Prevention (CDC), the Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP).

"Physician" means any person licensed to practice medicine in any of the 50 states or the District of Columbia.

"School" means:

1. Any public school from kindergarten through grade 12 operated under the authority of any locality within the Commonwealth;

2. Any private or religious school that offers instruction at any level or grade from kindergarten through grade 12;

3. Any private or religious nursery school or preschool, or any private or religious child care center required to be licensed by the Commonwealth;

4. Any preschool classes or Head Start classes operated by the school divisions within the Commonwealth; and

5. Any family day home or developmental center.

"Student" means any person who seeks admission to a school, or for whom admission to a school is sought by a parent or guardian, and who will not have reached 20 years of age by the start of the school term for which admission is sought.

"Twelve months of age" means the 365th day following the date of birth. For the purpose of evaluating records, vaccines administered up to four days prior to the first birthday (361 days following the date of birth) will be considered valid.

History

• Statutory Authority: §§ 22.1-271.2, 32.1-46, and 32.1-47 of the Code of Virginia.
• Historical Notes: Derived from VR355-28-300 § 1.1, eff. August 13, 1992; amended, Virginia Register Volume 11, Issue 16, eff. August 1, 1995; Volume 26, Issue 11, eff. March 3, 2010; Volume 32, Issue 7, eff. January 14, 2016; Volume 34, Issue 9, eff. February 10, 2018; Volume 42, Issue 19, eff. June 6, 2026.

Part II General Information

12VAC5-110-20 Purpose

This chapter is designed to ensure that all students attending any public or private elementary, middle, or secondary school, child care center, nursery school, family day care home, or developmental center in the Commonwealth are adequately immunized and protected against vaccine-preventable diseases as specified in this chapter.

History

• Statutory Authority: §§ 22.1-271.2, 32.1-12, and 32.1-46 of the Code of Virginia.
• Historical Notes: Derived from VR355-28-300 § 2.1, eff. August 13, 1992; amended, Virginia Register Volume 11, Issue 16, eff. August 1, 1995; Volume 26, Issue 11, eff. March 3, 2010; Volume 42, Issue 19, eff. June 6, 2026.

12VAC5-110-30 Administration

A. The Board of Health has the responsibility for promulgating regulations pertaining to the implementation of the school immunization law and standards of immunization by which a child attending any school may be judged to be adequately immunized.

B. The State Health Commissioner is the executive officer for the State Board of Health with the authority of the board when it is not in session, subject to the rules and regulations of the board.

C. The local health director is responsible for providing assistance in implementing this chapter to the school divisions in his jurisdiction and for providing immunizations to children determined not to be adequately immunized, who present themselves to the local health department for immunization.

D. The school principals of public schools and the principals, headmasters and directors of nonpublic schools shall require each student attending their institutions to provide documentary proof of immunization against the diseases listed in 12VAC5-110-70.

History

• Statutory Authority: §§ 22.1-271.2, 32.1-12, and 32.1-46 of the Code of Virginia.
• Historical Notes: Derived from VR355-28-300 § 2.2, eff. August 13, 1992; amended, Virginia Register Volume 11, Issue 16, eff. August 1, 1995; Volume 26, Issue 11, eff. March 3, 2010.

12VAC5-110-40 Application of chapter

This chapter has general application throughout the Commonwealth.

History

• Statutory Authority: §§ 22.1-271.1, 22.1-271.2, 32.1-12, and 32.1-46 of the Code of Virginia.
• Historical Notes: Derived from VR355-28-300 § 2.3, eff. August 13, 1992; amended, Virginia Register Volume 11, Issue 16, eff. August 1, 1995.

12VAC5-110-50 Application of the Administrative Process Act

This chapter is exempt from the requirements of Article 2 (§ 2.2-4006 et seq.) of the Virginia Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia); however, the Virginia Department of Health shall provide (i) a Notice of Intended Regulatory Action and (ii) for a 60-day public comment period prior to the board's adoption of the regulations.

History

• Statutory Authority: §§ 22.1-271.2, 32.1-12, and 32.1-46 of the Code of Virginia.
• Historical Notes: Derived from VR355-28-300 § 2.4, eff. August 13, 1992; amended, Virginia Register Volume 11, Issue 16, eff. August 1, 1995; Volume 26, Issue 11, eff. March 3, 2010; Volume 42, Issue 19, eff. June 6, 2026.

12VAC5-110-60 Powers and procedures of chapter not exclusive

The board reserves the right to authorize a procedure for enforcement of this chapter which is not inconsistent with the provisions set forth herein and the provisions of Chapter 2 (§ 32.1-35 et seq.) of Title 32.1 of the Code of Virginia.

History

• Statutory Authority: §§ 22.1-271.1, 22.1-271.2, 32.1-12, and 32.1-46 of the Code of Virginia.
• Historical Notes: Derived from VR355-28-300 § 2.7, eff. August 13, 1992; amended, Virginia Register Volume 11, Issue 16, eff. August 1, 1995.

Part III Immunization Requirements

12VAC5-110-70 Immunization requirements

Every student enrolling in a school shall provide documentary proof of adequate immunization with the prescribed number of doses of each of the vaccines and toxoids listed in this section, as appropriate for the child's age according to the immunization schedules. Spacing, minimum ages, and minimum intervals shall be in accordance with the immunization schedules. A copy of every student's immunization record shall be on file in the student's school record.

1. Diphtheria Toxoid. A minimum of four properly spaced doses of diphtheria toxoid. One dose shall be administered on or after the fourth birthday and prior to entering kindergarten.

2. Tetanus Toxoid. A minimum of four properly spaced doses of tetanus toxoid. One dose shall be administered on or after the fourth birthday and prior to entering kindergarten.

3. Pertussis Vaccine. A minimum of four properly spaced doses of pertussis vaccine. One dose shall be administered on or after the fourth birthday. A booster dose shall be administered prior to entering the grade seven.

4. Poliomyelitis Vaccine. A minimum of four doses of poliomyelitis vaccine with one dose administered on or after the fourth birthday and prior to entering kindergarten.

5. Measles (Rubeola) Vaccine. One dose of live measles vaccine administered at 12 months of age or older, and a second dose administered prior to entering kindergarten.

6. Rubella Vaccine. A minimum of one dose of rubella virus vaccine administered at 12 months of age or older.

7. Mumps Vaccine. One dose of mumps virus vaccine administered at 12 months of age or older and a second dose administered prior to entering kindergarten.

8. Haemophilus Influenzae Type b (Hib) Vaccine. A complete series of Hib vaccine (i.e., up to a maximum of four doses of vaccine as appropriate for the age of the child and the age at which the immunization series was initiated). The number of doses administered shall be in accordance with current immunization schedule recommendations. Attestation by the physician or the physician's designee, registered nurse, or an official of a local health department on that portion of Form MCH 213G pertaining to Hib vaccine shall mean that the child has satisfied the requirements of this subdivision. This subdivision shall not apply to children older than 60 months of age or for admission to any grade level, kindergarten through grade 12.

9. Hepatitis B Vaccine. A minimum of three doses of hepatitis B vaccine for all children. The FDA has approved a two-dose schedule only for adolescents 11 through 15 years of age and only when the Merck brand (RECOMBIVAX HB) Adult Formulation Hepatitis B vaccine is used. The two RECOMBIVAX HB adult doses must be separated by a minimum of four months. The two-dose schedule using the adult formulation must be clearly documented in the Hepatitis B section on Form MCH 213G.

10. Varicella (Chickenpox) Vaccine. Two properly spaced doses of varicella vaccine. The first dose shall be administered at 12 months of age or older and a second dose administered prior to entering kindergarten.

11. Pneumococcal Conjugate Vaccine (PCV). A complete series of PCV (i.e., up to a maximum of four doses of vaccine as appropriate for the age of the child and the age at which the immunization series was initiated). The number of doses administered shall be in accordance with current immunization schedule recommendations. Attestation by the physician or the physician's designee, registered nurse, or an official of a local health department on that portion of Form MCH 213G pertaining to PCV vaccine shall mean that the child has satisfied the requirements of this subdivision. This subdivision shall not apply to children older than 60 months of age or for admission to any grade level, kindergarten through grade 12.

12. Human Papillomavirus (HPV) Vaccine. Two doses of properly spaced HPV vaccine. The first dose shall be administered before the child enters the grade seven.

13. Rotavirus Vaccine. Two or three properly spaced doses of rotavirus vaccine, depending on the manufacturer, for children up to eight months of age.

14. Hepatitis A Vaccine. Two properly spaced doses of hepatitis A vaccine (HAV). The first dose shall be administered at 12 months of age or older and a second dose administered prior to entering kindergarten.

15. Meningococcal Conjugate Vaccine. Two properly spaced doses of meningococcal conjugate vaccine (MenACWY). The first dose shall be administered prior to entry to grade seven and a second dose shall be administered prior to entry to grade 12.

History

• Statutory Authority: §§ 22.1-271.2, 32.1-12, and 32.1-46 of the Code of Virginia.
• Historical Notes: Derived from VR355-28-300 § 3.1, eff. August 13, 1992; amended, Virginia Register Volume 11, Issue 16, eff. August 1, 1995; Volume 26, Issue 11, eff. March 3, 2010; Volume 31, Issue 1, eff. October 10, 2014; Volume 32, Issue 7, eff. January 14, 2016; Volume 35, Issue 23, eff. August 9, 2019; Volume 42, Issue 19, eff. June 6, 2026.

12VAC5-110-80 Exemptions from immunization requirements

A. Religious and medical exemptions. No certificate of immunization shall be required of any student for admission to school if:

1. The student or his parent or guardian submits a notarized Certificate of Religious Exemption (Form CRE 1), to the admitting official of the school to which the student is seeking admission. Form CRE 1 is an affidavit stating that the administration of immunizing agents conflicts with the student's religious tenets or practices. The form is available on the Division of Immunization website at http://www.vdh.virginia.gov/immunization/requirements; or

2. The school has written certification on either of the documents specified under "documentary proof" in 12VAC5-110-10 from a physician, registered nurse, or a local health department that one or more of the required immunizations may be detrimental to the student's health. Such certification of medical exemption shall specify the nature and probable duration of the medical condition or circumstance that contraindicates immunization.

3. Upon the identification of an outbreak, potential epidemic, or epidemic of a vaccine-preventable disease in a public or private school, the commissioner has the authority to require the exclusion from such school of all children who are not immunized against that disease.

B. Demonstration of existing immunity. The demonstration in a student of antibodies against mumps, measles, rubella, or varicella in sufficient quantity to ensure protection of that student against that disease, shall render that student exempt from the immunization requirements contained in 12VAC5-110-70 for the disease in question. Such protection should be demonstrated by means of a serological testing method appropriate for measuring protective antibodies against mumps, measles, rubella, or varicella respectively. Reliable history of chickenpox disease diagnosed or verified by a health care provider shall render students exempt from varicella requirements.

C. HPV vaccine. Because the human papillomavirus is not communicable in a school setting, a parent or guardian, at the parent's or guardian's sole discretion, may elect for the parent's or guardian's child not to receive the HPV vaccine, after having reviewed materials describing the link between the human papillomavirus and cervical cancer approved for such use by the board.

History

• Statutory Authority: §§ 22.1-271.2, 32.1-12, and 32.1-46 of the Code of Virginia.
• Historical Notes: Derived from VR355-28-300 § 3.2, eff. August 13, 1992; amended, Virginia Register Volume 26, Issue 11, eff. March 3, 2010; Volume 32, Issue 7, eff. January 14, 2016; Volume 37, Issue 23, eff. July 5, 2021.

Part IV Procedures and Responsibilities

12VAC5-110-90 Responsibilities of admitting officials

A. Procedures for determining the immunization status of students. Each admitting official or the official's designee shall review, before the first day of each school year, the school medical record of every new student seeking admission to the school and that of every student enrolling in grade seven or 12 for compliance with the requirements prescribed in 12VAC5-110-70. Such review shall determine into which one of the following categories each student falls:

1. Students whose immunizations are adequately documented and complete in conformance with 12VAC5-110-70. Students with documentation of existing immunity to mumps, measles, rubella, or varicella as defined in 12VAC5-110-80 B shall be considered to be adequately immunized for such disease.

2. Students who are exempt from the immunization requirements of 12VAC5-110-70 because of medical contraindications or religious beliefs provided for by 12VAC5-110-80.

3. Students whose immunizations are inadequate according to the requirements of 12VAC5-110-70.

4. Students without any documentation of having been adequately immunized.

B. Notification of deficiencies. Upon identification of the students described in subdivisions A 3 and A 4 of this section, the admitting official shall notify the parent or guardian of the student:

1. That there is no, or insufficient, documentary proof of adequate immunization in the student's school records.

2. That the student cannot be admitted to school unless the student has documentary proof that the student is exempted from immunization requirements pursuant to 12VAC5-110-70.

3. That the student may be immunized and receive certification by a licensed physician, registered nurse, or an official of a local health department.

4. How to contact the local health department to receive the necessary immunizations.

C. Conditional enrollment. Any student whose immunizations are incomplete may be admitted conditionally if that student provides documentary proof at the time of enrollment of having received at least one dose of the required immunizations accompanied by a schedule for completion of the required doses within 90 calendar days, during which time the student shall complete the immunizations required under 12VAC5-110-70. If the student requires more than two doses of hepatitis B vaccine, the conditional enrollment period, for hepatitis B vaccine only, shall be 180 calendar days. If a student is a homeless child or youth and does not have documentary proof of necessary immunizations or has incomplete immunizations and is not exempted from immunization as described in 12VAC5-110-80, the school administrator shall immediately admit such student and shall immediately refer the student to the local school division liaison, who shall assist in obtaining the documentary proof of, or completing, immunizations. The admitting official should examine the records of any conditionally enrolled student at regular intervals to ensure that such a student remains on schedule with the plan of completion.

D. Exclusion. The admitting official shall, at the end of the conditional enrollment period, exclude any student who is not in compliance with the immunization requirements under 12VAC5-110-70 and who has not been granted an exemption under 12VAC5-110-80 until that student provides documentary proof that the immunization requirements have been completed, unless documentary proof that a medical contraindication developed during the conditional enrollment period is submitted.

E. Transfer of records. The admitting official of every school shall be responsible for sending a student's immunization records or a copy thereof, along with the student's permanent academic or scholastic records, to the admitting official of the school to which a student is transferring within 10 days of the student's transfer to the new school.

F. Report of student immunization status. Each admitting official shall, within 30 days of the beginning of each school year or entrance of a student, or by October 15 of each school year, file with the Virginia Department of Health through the health department for the admitting official's locality, a report summarizing the immunization status of the students in the official's school as of the first day of school. This report shall be filed using the web-enabled reporting system or on the most current version of Form SIS, the Student Immunization Status Report, and shall contain the number of students admitted to that school with documentary proof of immunization, the number of students who have been admitted with a medical or religious exemption, and the number of students who have been conditionally admitted.

G. Immunization records shall be open to inspection by health department officials.

H. Each admitting official shall ensure that the parent or guardian of a child to be enrolled in grade seven receives educational materials describing the link between the human papillomavirus and cervical cancer. Materials shall be approved by the board and provided to the parent or guardian prior to the child's enrollment in grade seven.

History

• Statutory Authority: §§ 22.1-271.2, 32.1-46, and 32.1-47 of the Code of Virginia.
• Historical Notes: Derived from VR355-28-300 § 4.1, eff. August 13, 1992; amended, Virginia Register Volume 11, Issue 16, eff. August 1, 1995; Volume 26, Issue 11, eff. March 3, 2010; Volume 32, Issue 7, eff. January 14, 2016; Volume 34, Issue 9, eff. February 10, 2018; Volume 42, Issue 19, eff. June 6, 2026.

12VAC5-110-100 Responsibilities of physicians and local health departments

A. Documentary proof for students immunized in Virginia. Every physician, registered nurse, and local health department providing immunizations to a child shall provide documentary proof, as defined in 12VAC5-110-10, to the child or his parent or guardian of all immunizations administered.

B. Documentary proof for out-of-state students. For a student transferring from an out-of-state school to a Virginia school, the admitting official may accept as documentary proof any immunization record for that student that is signed by a physician or registered nurse and that contains the exact date (month/day/year) of administration of each of the required doses of vaccines when indicated and that complies fully with the requirements prescribed under 12VAC5-110-70. Any immunization record that does not contain the signature of a physician or a nurse and does not contain the month/day/year of administration of each of the required vaccine doses shall not be accepted by the admitting official as documentary proof of adequate immunization. Such a student's record shall be evaluated by an official of the local health department who shall determine if that student is adequately immunized in accordance with the provisions of 12VAC5-110-70. Should the local health department determine that such a student is not adequately immunized, that student shall be referred to his private physician or local health department for any required immunizations.

History

• Statutory Authority: §§ 22.1-271.2, 32.1-12, and 32.1-46 of the Code of Virginia.
• Historical Notes: Derived from VR355-28-300 § 4.2, eff. August 13, 1992; amended, Virginia Register Volume 26, Issue 11, eff. March 3, 2010.

Part V Penalties

12VAC5-110-110 Exclusion of students

Any student who fails to provide documentary proof of immunization in the manner prescribed, within the time periods provided for in these regulations and §§ 22.1-271.1 and 22.1- 271.2 of the Code of Virginia, shall be excluded from school attendance by the school's admitting official.

History

• Statutory Authority: §§ 22.1-271.1, 22.1-271.2, 32.1-12, and 32.1-46 of the Code of Virginia.
• Historical Notes: Derived from VR355-28-300 § 5.1, eff. August 13, 1992.

12VAC5-110-120 Exclusion of students unprotected against vaccine-preventable diseases

In accordance with § 32.1-47 of the Code of Virginia, any student exempted from immunization requirements pursuant to 12VAC5-110-80 A, shall be excluded from school attendance for his own protection until the danger has passed, if the commissioner so orders such exclusion upon the identification of an outbreak, potential epidemic or epidemic of a vaccine-preventable disease in that student's school.

History

• Statutory Authority: §§ 22.1-271.1, 22.1-271.2, 32.1-12, and 32.1-46 of the Code of Virginia.
• Historical Notes: Derived from VR355-28-300 § 5.2, eff. August 13, 1992.

12VAC5-110-130 Responsibility of parent to have a child immunized

In accordance with § 32.1-46 of the Code of Virginia, the parent, guardian or person standing in loco parentis of each child within this Commonwealth shall ensure such child is immunized in accordance with the immunization schedule.

The parent or guardian of a child who is home instructed shall ensure such child is immunized in accordance with § 22.1-271.4 of the Code of Virginia.

Penalties for noncompliance shall be in accordance with § 32.1-27 of the Code of Virginia.

History

• Statutory Authority: §§ 22.1-271.2, 32.1-12 and 32.1-46 of the Code of Virginia.
• Historical Notes: Derived from VR355-28-300 § 5.3, eff. August 13, 1992; amended, Virginia Register Volume 11, Issue 16, eff. August 1, 1995; Volume 26, Issue 11, eff. March 3, 2010.

12VAC5-110-140 (Repealed.)

History

• Historical Notes: Derived from VR355-28-300 § 5.4, eff. August 13, 1992; amended, Virginia Register Volume 11, Issue 16, eff. August 1, 1995; repealed, Volume 26, Issue 11, eff. March 3, 2010.

Chapter 165 Regulations for the Repacking of Crab Meat

Part I General Provisions

12VAC5-165-10 Definitions

The following words and terms when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise:

"Action level" means the limit established for a deleterious substance present in a product or the environment, above which level prescribed actions by the division may be required to protect public health.

"Certificate of Inspection" means a numbered certificate issued by the division to a shipper after an inspection confirms compliance with applicable regulations and standards.

"Certification number" means a unique number assigned to each shipper upon issuance of a Certificate of Inspection.

"Certified laboratory" means a laboratory certified by the U.S. Food and Drug Administration for analysis of food products.

"Critical Control Point" or "CCP" means a point, step or procedure in a food process at which control can be applied, and a food safety hazard can, as a result, be prevented, eliminated or reduced to acceptable numbers.

"Critical limit" means the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.

"Division" means the Division of Shellfish Sanitation of the Virginia Department of Health.

"Establishment" means any vehicle, vessel, property, or premises where crustacea, finfish or shellfish are transported, held, stored, processed, packed, repacked or pasteurized in preparation for marketing.

"HACCP plan" means a written document that delineates the formal procedures that a dealer follows to implement a Hazard Analysis Critical Control Point methodology to assure food safety.

"Hazard analysis" means a process used to determine whether there are food safety hazards that are reasonably likely to occur while repacking crab meat and to identify the preventive measures that the repacker can apply to control those hazards.

"Importer" means either the owner or consignee at the time of entry of the crab meat into the United States, or the agent or representative of the foreign owner or consignee at the time of entry into the United States, who is responsible for ensuring that goods being offered for entry into the United States are in compliance with all laws affecting the importation.

"Lot" means repacked crab meat that bears the same repack date and source code.

"Preventive measure" means actions taken to prevent or control a food safety hazard.

"Principal display panel" means the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale.

"Processing" means cooking, picking, packing, repacking or pasteurizing crab meat.

"Processor" means any person engaged in commercial, custom, or institutional processing of crab meat, either in the United States or in a foreign country.

"Repacker" means a person who operates an establishment that transfers crab meat from a container originally packed by another establishment to another container.

"Repacking operation" means a process of transferring crab meat from the original shipper's packing container to a different packing container, including all steps beginning with the removal of the original containers of meat from the repacker's refrigeration and ending with the repacked crab meat in properly identified containers placed into refrigeration.

"Shipper" means a person who operates an establishment for the cooking, picking, repacking or pasteurizing of crab meat.

"Source code" means a code designated by the repacker which represents the crab processing facility where crab meat was obtained.

History

• Statutory Authority: § 28.2-801 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000; amended, Virginia Register Volume 32, Issue 5, eff. December 2, 2015.

12VAC5-165-20 Compliance with the Administrative Process Act

The provisions of the Virginia Administrative Process Act (§ 9-6.14:1 et seq. of the Code of Virginia) shall govern the promulgation and administration of these regulations and shall be applicable to the appeal of any case decision based upon this chapter.

History

• Statutory Authority: §§ 28.2-801, 28.2-803 and 28.2-806 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000.

12VAC5-165-30 Powers and procedures of regulations not exclusive

The commissioner may enforce this chapter through any means lawfully available.

History

• Statutory Authority: §§ 28.2-801, 28.2-803 and 28.2-806 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000.

12VAC5-165-40 Certificate of Inspection required

No person, firm or corporation shall operate an establishment for the repacking or relabeling of crab meat until the establishment first obtains the approval of the State Health Commissioner in the form of a Certificate of Inspection. Application for a Certificate of Inspection shall be submitted to the appropriate field office or central office.

History

• Statutory Authority: §§ 28.2-801, 28.2-803 and 28.2-806 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000.

12VAC5-165-50 Hazard Analysis Critical Control Point (HACCP) plan

An establishment for the repacking or relabeling of crab meat shall have and maintain an approved Hazard Analysis Critical Control Point (HACCP) plan to include, at a minimum, the following:

1. A hazard analysis;

2. The identification of preventive measures;

3. The identification of critical control points;

4. The establishment of critical limits for each critical control point;

5. The monitoring records of each critical control point;

6. The establishment of corrective action when a critical limit deviation occurs;

7. The establishment and maintenance of a recordkeeping system; and

8. The establishment of verification procedures.

History

• Statutory Authority: §§ 28.2-801, 28.2-803 and 28.2-806 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000.

12VAC5-165-60 Scope of embargo

In the event of a recall or embargo of repacked crab meat, the entire production bearing the lot number will normally be recalled or embargoed, unless a verifiable sublot coding system has been used.

History

• Statutory Authority: §§ 28.2-801, 28.2-803 and 28.2-806 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000.

12VAC5-165-70 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000; repealed, Virginia Register Volume 32, Issue 5, eff. December 2, 2015.

Part II Sources of Crab Meat for Repacking

12VAC5-165-80 Source facility requirements

Crab meat for repacking shall be picked and packed by a crab processing establishment that (i) is currently licensed, permitted or certified and inspected by either a state public health authority or by a foreign government public health authority and (ii) shall operate under a HACCP plan approved by the state or a foreign government public health authority, or the U.S. Food and Drug Administration. Imported crab meat shall meet the requirements for imported products set forth in 21 CFR 123.12 (60 FR 65197, December 18, 1995).

History

• Statutory Authority: § 28.2-801 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000; amended, Virginia Register Volume 32, Issue 5, eff. December 2, 2015.

12VAC5-165-90 Verification of shipping temperatures for crab meat

The repacker shall provide a record of transport temperature receiving conditions for each shipment of crab meat. Temperature recording may be by maximum temperature recording, continuous temperature recording, or by other device such as adequate amount of ice or adequate quantity of chemical cooling media. The repacker shall include the transport receiving temperature conditions as a part of the receiving CCP in the HACCP plan.

History

• Statutory Authority: § 28.2-801 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000; amended, Virginia Register Volume 32, Issue 5, eff. December 2, 2015.

12VAC5-165-100 Sampling and analysis requirements for imported crab meat

A. When imported crab meat is used as a source for repacking, the importer or repacker may take samples from each lot prior to processing to be analyzed by a certified laboratory and maintain on file a copy of the sampling results for a minimum of one year. The action levels for the crab meat sampled are as follows:

1. Pasteurized crab meat.

a. Aerobic plate count; action level of >3,000/g.

b. Fecal coliforms; action level of >20/100g.

2. All other crab meat.

a. Aerobic plate count; action level of >100,000/g.

b. Fecal coliforms; action level of >93/100g.

B. When imported crab meat is used as a source for repacking, the importer or repacker may take a minimum of five samples from every shipment to be tested for decomposition by organoleptic sensing technique and shall maintain a copy of such results on file for a minimum of one year.

C. If any sample is found to exceed an action level or guideline, or is found to show evidence of decomposition, the repacker shall stop processing the lot sampled and determine the disposition of that lot.

D. All records of sample analyses kept on file at the repacker's establishment shall be made available for review by the division. These records shall be maintained for a period of one year from the date of processing for products packaged for fresh distribution, and two years for products packaged for frozen or pasteurized distribution.

History

• Statutory Authority: § 28.2-801 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000; Errata, 16:19 VA.R. 2399 June 5, 2000; amended, Virginia Register Volume 32, Issue 5, eff. December 2, 2015.

12VAC5-165-110 Verification of pasteurization for imported crab meat

If the crab meat for repacking was pasteurized in an establishment outside the United States, the repacker shall obtain a letter from the foreign crab meat producer stating that the crab meat has received a pasteurization process equivalent of F¹⁶₁₈₅=31 minutes and was processed utilizing HACCP controls.

History

• Statutory Authority: §§ 28.2-801, 28.2-803 and 28.2-806 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000.

12VAC5-165-120 Verification of container integrity for imported, pasteurized crab meat

The repacker shall evaluate the container integrity of all imported, pasteurized crab meat products. These evaluations shall also be conducted after any pasteurization by the repacker. This evaluation shall at a minimum include visual inspection of all containers for evidence of leaks. A record of inspection shall be maintained on file by the repacker for a minimum of one year.

History

• Statutory Authority: § 28.2-801 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000; amended, Virginia Register Volume 32, Issue 5, eff. December 2, 2015.

Article 1 Processing

12VAC5-165-130 Separation of operations

Article 1 Processing

All crab meat repacking operations shall be conducted separately in time or space from other packing operations.

History

• Statutory Authority: §§ 28.2-801, 28.2-803 and 28.2-806 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000.

12VAC5-165-140 Cleaning and sanitizing of tables

The repacking tables shall be cleaned and sanitized prior to and after each crab meat repacking operation.

History

• Statutory Authority: §§ 28.2-801, 28.2-803 and 28.2-806 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000.

12VAC5-165-150 Pasteurized crab meat storage temperature

Containers of pasteurized crab meat shall be stored in a refrigerated room at a temperature of 40°F or less.

History

• Statutory Authority: § 28.2-801 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000; amended, Virginia Register Volume 32, Issue 5, eff. December 2, 2015.

12VAC5-165-160 Blending of crab meat

Foreign crab meat from one processor shall not be blended or combined with crab meat from another processor.

History

• Statutory Authority: §§ 28.2-801, 28.2-803 and 28.2-806 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000.

12VAC5-165-170 Temperature of crab meat during repacking

No portion of the crab meat shall exceed 50°F during the repacking process.

History

• Statutory Authority: §§ 28.2-801, 28.2-803 and 28.2-806 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000.

12VAC5-165-180 Cooling of crab meat after repacking

Immediately after repacking, the repacker shall place containers of repacked crab meat into ice or into refrigeration not to exceed 40°F.

History

• Statutory Authority: § 28.2-801 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000; amended, Virginia Register Volume 32, Issue 5, eff. December 2, 2015.

12VAC5-165-190 Disposal of used containers

Empty containers from which crab meat has been repacked shall not be kept on premises for any type of reuse. After removing the crab meat, the empty containers shall be placed immediately into waste disposal receptacles.

History

• Statutory Authority: §§ 28.2-801, 28.2-803 and 28.2-806 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000.

12VAC5-165-200 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000; repealed, Virginia Register Volume 32, Issue 5, eff. December 2, 2015.

Article 2 Labeling

12VAC5-165-210 Certification number to be on containers

Article 2 Labeling

Crab meat shall be repacked only into containers bearing the repacker's Virginia certification number.

History

• Statutory Authority: §§ 28.2-801, 28.2-803 and 28.2-806 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000.

12VAC5-165-220 Lot numbers

A. Containers of repacked crab meat shall be stamped or embossed with the lot number.

B. Lot numbers shall consist of a repack date and a code indicating the original processor. Records shall be maintained by the repacker for a minimum of one year with an explanation of the code.

History

• Statutory Authority: § 28.2-801 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000; amended, Virginia Register Volume 32, Issue 5, eff. December 2, 2015.

12VAC5-165-230 Country of origin for imported crab meat

Imported crab meat shall be packed by the repacker into containers that bear a declaration of the country of origin of the repacked crab meat.

History

• Statutory Authority: § 28.2-801 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000; amended, Virginia Register Volume 32, Issue 5, eff. December 2, 2015.

Article 3 Records and Recordkeeping

12VAC5-165-240 Accessibility of records

Article 3 Records and Recordkeeping

All required records shall be maintained by the repacker and shall be made available to the division for inspection.

History

• Statutory Authority: § 28.2-801 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000; amended, Virginia Register Volume 32, Issue 5, eff. December 2, 2015.

12VAC5-165-250 Crab meat sources and source coding

The repacker shall maintain records clearly indicating the sources of crab meat used for repacking in relation to the source code identified on the containers of repacked crab meat.

History

• Statutory Authority: §§ 28.2-801, 28.2-803 and 28.2-806 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000.

12VAC5-165-260 Traceability of repacked crab meat

The individual lots of crab meat shall be easily traceable from their source through the repacking process to the buyer and from the buyer back through the repacker to the particular lot source.

History

• Statutory Authority: §§ 28.2-801, 28.2-803 and 28.2-806 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000.

12VAC5-165-270 Minimum records to be kept

The repacker shall maintain the following information on each lot of repacked crab meat for a minimum of one year: (i) the original processor information, (ii) verification records of shipping temperature conditions, (iii) records required by the repacker's HACCP plan, and (iv) repacked crab meat sales records. Additional clarifying records may be required by the division to identify lot codes on containers.

History

• Statutory Authority: § 28.2-801 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000; amended, Virginia Register Volume 32, Issue 5, eff. December 2, 2015.

12VAC5-165-280 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000; repealed, Virginia Register Volume 32, Issue 5, eff. December 2, 2015.

Article 4 Penalties

12VAC5-165-290 (Repealed.)

Article 4 Penalties

History

• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000; repealed, Virginia Register Volume 32, Issue 5, eff. December 2, 2015.

12VAC5-165-300 Operating without a Certificate of Inspection

Persons processing crab meat for marketing without a valid Certificate of Inspection shall be guilty of a Class 1 misdemeanor.

History

• Statutory Authority: §§ 28.2-801, 28.2-803 and 28.2-806 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000.

12VAC5-165-310 Improper labeling of foreign crab meat

Persons, even if operating in a facility with a valid Certificate of Inspection, shall be guilty of a Class 1 misdemeanor if found to be packing or repacking foreign crab meat into a container without the country of origin indicated on the principal display panel.

History

• Statutory Authority: §§ 28.2-801, 28.2-803 and 28.2-806 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000.

Chapter 195 Virginia WIC Program

Part I General Provisions

12VAC5-195-10 General authority

The Special Supplemental Nutrition Program for Women, Infants and Children (WIC) was authorized as part of the Child Nutrition Act of 1966, Section 17 (42 USC § 1786), to provide supplemental foods and nutrition education to pregnant, postpartum and breastfeeding women, infants and young children from families with inadequate income. The Virginia WIC Program is regulated by federal regulations published in the Code of Federal Regulations, 7 CFR Part 246, Special Supplemental Nutrition Program for Women, Infants and Children. The state regulations shall serve as a supplement to 7 CFR Part 246.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 29, Issue 12, eff. March 13, 2013.

12VAC5-195-20 Purpose

A. The Virginia Women, Infants and Children (WIC) Program serves women who are breastfeeding, pregnant, or have just given birth; infants younger than one year old; and children younger than five years old. WIC participants must be Virginia residents and meet the financial and nutritional requirements.

B. The Virginia WIC Program provides special supplemental foods to eligible participants through a retailer delivery system (7 CFR 246.12). Food benefits are issued by local agencies to eligible participants using food instruments (7 CFR 246.10). Participants redeem their food instruments at any authorized retailer or entity. The state agency enters into an agreement with authorized retailers (7 CFR 246.12). This agreement identifies the obligations, rights, and responsibilities of both the authorized retailers and the state agency. The state agency pays authorized retailers a reasonable dollar amount for the foods purchased, as listed on the approved food list (7 CFR 246.12).

C. The state agency shall promulgate policies, guidelines, manuals, and training resources to facilitate operations of the Virginia WIC Program in accordance with its contractual agreement with Food Nutrition Service (FNS) (7 CFR 246.3); the guidelines and instructions issued by FNS in policy letters; and management evaluations, audits, and the WIC Program State Plan of Operations.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 29, Issue 12, eff. March 13, 2013; Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-30 Definitions

The following words and terms when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise:

"Administrative review" means the procedure through which applicants or retailers may appeal a state agency's administrative action, including program disqualification, denied authorization, and other adverse actions.

"Agency representative" means staff from the state agency, a local agency, a contractor, or other designated individuals trained to conduct WIC functions and monitor retailers.

"Approved food list" or "WIC Approved Food List, April 1, 2018, Virginia Department of Health" means a brochure or method used by the WIC Program to communicate to eligible participants, retailers, local agencies, and other interested parties which authorized supplemental foods may be purchased using WIC food instruments. The approved food list is a guide and must be used with the food instrument, which may identify specific brands or additional products not stated on the approved food list that may be purchased by participants.

"Authorization" means the process by which the state agency assesses, selects, and enters into an agreement with retailers that apply or subsequently reapply to be authorized.

"CAPP Manual" or "CAPP Manual, Volume No. 1 – Policies & Procedures, Section No. 20500 – Accounts Receivable, Cardinal, August 2018, Office of the Comptroller, Commonwealth of Virginia" means the Commonwealth's Accounting Policies and Procedures (CAPP) Manual, which provides guidelines, policies, procedures, and regulations to assist and govern state agencies to develop procedures to properly account for, report, manage, and collect receivables.

"Caretaker" means a person 18 years of age or older, unless approved at the discretion of a competent professional authority, designated by a parent or legal guardian to certify an infant or child, obtain and redeem food instruments and attend nutrition education. A caretaker may be any person who has detailed knowledge of the nutritional needs and eating habits of the infant or child. A parent or legal guardian may designate one caretaker per family ID number.

"Cash value food benefits" means a special food instrument that has been issued to eligible participants for a specific dollar amount that must be used to purchase fruits and vegetables. Unless stated otherwise, all references to food instruments include cash value food benefits, as well as food and formula food instruments.

"Civil monetary penalty" or "CMP" means an administrative fine offered to a retailer in lieu of disqualification if inadequate participant access exists as determined by the state agency.

"Direct deposit ACH" means a method used to reimburse retailers for certain types of processed food instruments (i.e., "Over FI Max"). A credit is made to the retailer's designated bank account and routing number using the automated clearinghouse (ACH) process.

"Enrollment" means the process all applicants and authorized retailers must complete in order for a retailer to be eligible to accept WIC food instruments.

"FNS" means the U.S. Department of Agriculture Food and Nutrition Services.

"Food instrument" means a voucher, check, electronic benefits transfer card (EBT), coupon, or other document that is used by a participant to obtain supplemental foods.

"Formula flyer" or "Virginia WIC Program, Infant Formula Flyer, February 2018, Virginia Department of Health" means a handout or method used by the state agency to communicate to eligible participants, retailers, local agencies, and other interested parties that formulas may be purchased at authorized retailers.

"Informal settlement meeting" means a meeting held with an authorized retailer or applicant representative and the state WIC director whose purpose is to review and clarify outstanding WIC Program administrative issues.

"Legal guardian" means an individual who has been appointed by a court of law or the Department of Social Services, or by other legal means, to have primary, physical custody of a minor. A legal guardian shall be authorized to provide eligibility information for an applicant, consent to medical treatment of the applicant, and shall be held legally bound if sanctions are imposed.

"NTE" means not to exceed.

"Peer group" means a classification of applicants and authorized retailers into groups based on common characteristics or criteria that affect food prices for the purpose of applying appropriate competitive price criteria to retailers at authorization and limiting payments for foods at competitive pricing levels. A retailer's peer group is used to determine competitive pricing levels at initial authorization and establish the reimbursement maximums paid by the state agency.

"Post-payment review" means an analysis of paid food instruments redeemed by authorized retailers in order to determine if pricing and redemption discrepancies exist. Based upon this analysis, a retailer claim against the retailer may be established by the state agency.

"Relatives" means spouses, parents, children, brothers, sisters, aunts, uncles, nephews, nieces, grandparents, and grandchildren.

"Retailer" means a vendor, retail store, commissary, or entity authorized by the Virginia WIC Program to accept WIC food instruments for the various types of foods listed on the approved food list. The term "retailer" is equivalent to the term "vendor" used in federal regulations (7 CFR 246.12).

"Retailer agreement" or "Virginia WIC Program's Retailer Agreement, January 2019, Virginia Department of Health" means a written agreement that establishes the respective roles and responsibilities of the state agency and authorized retailers in complying with federal and state requirements.

"Retailer claim" means the state agency has determined an authorized retailer committed a violation of the retailer agreement that affects the payment status of one or several food instruments.

"Retailer manual" or "Retailer Manual for the Virginia WIC Program, April 1, 2018, Virginia Department of Health" means a series of written documents that communicate administrative procedures for the Virginia WIC Program that regulate both authorized retailers and applicants. The retailer manual is part of the WIC Program State Plan that must be submitted and approved by USDA.

"Sanctions" or "Virginia WIC Program – Sanction Violation Schedule, May 1, 2017, Virginia Department of Health" means the schedule of penalties imposed by the state agency upon an authorized retailer for a specific violation outlined in the retailer manual or retailer agreement.

"State agency"means the Virginia Department of Health and the delegated authority to the Division of Community Nutrition, which has the administrative responsibility for managing the Virginia WIC Program.

"Termination" means the act of ending a retailer's WIC Program authorization for administrative reasons that include a change of ownership, closed retailer location, voluntary withdrawal, and noncompetitive prices.

"UPC" means Universal Product Code.

"USDA memo" or "USDA Memo – SFP 09-020 Clarification on Use of the WIC Acronym and Logo, January 9, 2009, United States Department of Agriculture, Food and Nutrition Service" means a memo drafted by the federal government to provide guidance to states on the use of the WIC program's acronym and logo.

"Unique participant" means the number of unduplicated individuals who have redeemed one or more food instruments at a retail store during a specific period.

"U.S. Department of Agriculture" or "USDA" meansthe federal agency that provides funding for the WIC Program on behalf of Congress.

"Waiting list" means a list implemented by the state agency for individual participants when the maximum caseload is reached.

"WIC sales" means annual sales based on WIC redemption paid by the state agency to an authorized retailer.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 26, Issue 10, eff. January 18, 2010; Volume 29, Issue 12, eff. March 13, 2013; Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-40 (Reserved)

Historical Notes

Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008.

12VAC5-195-50 (Reserved)

Historical Notes

Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008.

12VAC5-195-60 (Reserved)

Historical Notes

Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008.

Part II Participant Requirements

12VAC5-195-70 Eligibility requirements

A. Adjunctive financial eligibility requirements. Adjunctive or automatic financial eligibility is determined pursuant to 7 CFR 246.7. Documentation is required as proof of participation in programs that qualify an applicant for adjunctive financial eligibility. The state agency also allows Family Access to Medical Insurance Security Plan (FAMIS) and a $2.00 co-pay level to be used in determining adjunctive financial eligibility.

B. Local agencies shall serve institutionalized applicants if they meet all eligibility requirements.

C. For determining income eligibility, local agency personnel shall use the applicant's current or annualized income, whichever is the best indication of circumstances.

D. In determining income eligibility, the state agency shall utilize all income exclusions listed in 7 CFR 246.7.

E. Applicants who are not adjunctively financially eligible shall have financial eligibility determined using income guidelines equaling the income guidelines established under § 9 of the National School Lunch Act for reduced price school meals per 7 CFR 246.7.

F. An applicant claiming multiple fetuses shall have the stated number used at the time of certification, but shall be required to provide written verification by a physician or nurse practitioner working under the supervision of a physician within 60 days of certification.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 29, Issue 12, eff. March 13, 2013; Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-80 Proof of identification

Applicants shall present proof of identification to obtain all WIC services and benefits. This includes certification and subsequent certification visits, food instrument issuance, special formula issuance, nutrition education, and verification of certification transfers. The local agency shall only accept the following as proof of identification:

1. Valid Medicaid card or letter;

2. Social Security card;

3. Driver's license;

4. Birth certificate;

5. Marriage license;

6. Crib card for newborns;

7. Hospital card for newborns;

8. Military identification card or discharge papers (DD214);

9. Clinic or hospital record or ID;

10. TANF or welfare photo ID;

11. Refugee settlement papers;

12. Immigration or Naturalization Record (e.g., green card);

13. Passport or visa; and

14. School records (ID or report card, enrollment or health record).

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-90 Proof of residency

A. Applicants shall present proof of residency at initial certification and subsequent certification visits. Proof of residency shall be current and include the applicant's name. The local agency shall accept the following as proof of residency:

1. Utility bills;

2. Other business mail with a Virginia address;

3. Deed, mortgage, monthly mortgage statement, or residential rental or lease agreement;

4. Valid Virginia driver's license;

5. Valid Medicaid Card or positive, official Medicaid Verification; or

6. TANF or welfare photo ID.

B. Proof of residency for military personnel shall be current and include the applicant's name. The local agency shall accept the following as proof of residency for military personnel:

1. A letter from the company commander on official letterhead;

2. A copy of official Department of Defense orders with Virginia installation assignment; or

3. A leave and earning statement (LES) listing Virginia as the service member's home of record.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-100 Proxy

A. A participant, parent or legal guardian may have the privilege, but not the right, to designate a maximum of two proxies. A proxy may accept and redeem food instruments. The proxy must attend nutrition education to obtain food instruments. The participant and proxy are not required to be present together when the participant designates the proxy. The parent is encouraged to be the primary recipient of all WIC instruments.

B. Local agency personnel shall only discuss the option of designating a proxy if the participant, parent or legal guardian indicates one of the following situations:

1. The participant, parent or legal guardian expresses difficulty with attending the local agency for nutrition education WIC instruments;

2. The local agency determines difficulty with the participant, parent or legal guardian attending the local agency through objective methods such as the no show reports, missed appointments, or frequently rescheduled appointments; or

3. The local agency determines difficulty with the participant, parent or legal guardian attending the local agency during established alternative hours.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008.

12VAC5-195-110 Caretaker

A. A parent or legal guardian may have the privilege, but not the right, to designate one caretaker per family ID number to certify an infant or child who may obtain and redeem food instruments and attend nutrition education. The caretaker assumes all of the rights and responsibilities of the parent or legal guardian who designates him. A caretaker shall be designated only when the local agency cannot accommodate the needs of the parent to attend the local agency to obtain WIC benefits. In the absence of a parent or legal guardian, a caretaker shall provide reasonable documentation of his status as a primary caretaker. Reasons supporting the designation of a caretaker shall be documented and become part of the participant's record. The authority to implement the caretaker policy will be granted individually to local agencies by the state WIC director. The parent is always encouraged to be the primary recipient of all WIC benefits.

B. A caretaker may be designated in two situations:

1. A parent or legal guardian's declaration of hardship; or

2. The caretaker providing reasonable documentation of his role in the absence of a parent or legal guardian.

C. Local agency personnel shall discuss the option of designating a caretaker if the participant, parent, or legal guardian declares hardship that prevents him from coming to the local agency during established regular and alternative hours due to:

1. Conflict of schedules due to work, school, or some other valid reason;

2. Lack of transportation;

3. An infant or child residing with a family member or caretaker; or

4. The parent or legal guardian being sanctioned from the program.

D. The caretaker shall provide reasonable documentation to substantiate his relationship with the infant or child and his role as primary caretaker. Reasonable documentation may include:

1. Signed caretaker designation form, WIC-311, indicating the designation of caretaker that may be obtained prior to the first local agency visit;

2. Signed and witnessed letter from the legal guardian or parent designating a caretaker and reason for the legal guardian's or parent's inability to certify an infant or child, obtain and redeem food instruments, and attend nutrition education; or

3. Documentation of the parent or legal guardian's enrollment, residence, or confinement in a hospital treatment program, shelter, penal institution, or other institution.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 29, Issue 12, eff. March 13, 2013; Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-120 Certification

A. The certification process begins when an applicant contacts the local agency to make an oral or written request for WIC benefits.

B. A local agency may choose to serve participants who live outside of their local agency geographic area, but within the state, in cases of hardship.

C. Breastfeeding women shall be certified up to the last day of the month in which her infant turns one year old or until the woman ceases breastfeeding, whichever occurs first.

D. Infants shall be certified up to their first birthday.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008.

12VAC5-195-130 Nutritional risk priority system

The state agency places pregnant, breastfeeding, or postpartum women, infants and children who are at nutritional risk solely because of homelessness and migrancy in Priority VII, per 7 CFR 246.7. The state agency does not expand or adjust any other priority level listed in 7 CFR 246.7.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008.

12VAC5-195-140 Food instruments

A. Food instrument issuance . All food instruments shall be issued through the automated system only after eligibility has been documented and when the participant, parent or legal guardian, caretaker, or proxy is physically present at the local agency to have their food benefits loaded, except when there is a system outage or system failure. Failure by the participant, parent, legal guardian, caretaker, or proxy to attend the initial nutrition education appointment may result in reduced WIC benefits for that month.

B. Lost food instruments. Lost food instruments shall only be replaced for one of the following situations:

1. A participant leaving home because of domestic violence;

2. A change in full legal custody, including when infants or children are removed from home and placed in foster care or parental custody is changed; or

3. An event out of the control of participant, such as a fire or natural disaster that is publicly documented.

C. Stolen food instruments. Food instruments reported as stolen shall only be replaced when a police report is provided that states that the valid, not redeemed, WIC food instruments were stolen. Stolen food instruments shall not be replaced without a police report, unless costs are associated with the police report and a waiver is granted by the state agency.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 29, Issue 12, eff. March 13, 2013; Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-150 Alternative office hours

Alternative office hours shall be offered outside of the regular operating hours of Monday through Friday, between 8 a.m. and 4:30 p.m. to address barriers in accessing WIC services for current and potential applicants and participants. The local agency shall offer a minimum of 16 alternative office hours per month and provide documentation to the state agency that the alternative hours accommodate the needs of the current client caseload.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 29, Issue 12, eff. March 13, 2013.

12VAC5-195-160 Waiting lists

The state agency shall provide local agencies with approval before waiting lists are implemented.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008.

12VAC5-195-170 Termination

Participants who fail to obtain food instruments for 90 days after the last date to spend during a certification period shall be automatically terminated from the WIC Program.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008.

12VAC5-195-180 Fair hearing

A. The Virginia WIC Program is a federally administered program. The following fair hearing procedures are a federal process with which the state agency must comply. Pursuant to 7 CFR 246.9, the state agency shall provide a hearing procedure through which any individual may appeal a state or local agency action that results in a claim against the individual for repayment of the cash value of improperly issued benefits or results in the individual's denial of participation or disqualification from the program.

B. The local agency shall inform each individual in writing of the right to a fair hearing at the time of a claim against an individual for improperly issued benefits or at the time of participation denial or of disqualification from the program.

C. A fair hearing shall be requested within 60 days of the written notification date of program denial, termination of benefits, or claim against an individual for improperly issued benefits. The request shall be made in any clear expression to present the case to a higher authority.

D. Participants who appeal the termination of benefits within 15 days must continue to receive WIC benefits until the hearing officer reaches a decision, the participant becomes categorically ineligible, or the certification period expires, whichever comes first.

E. Applicants who are denied WIC benefits at the initial certification or because of the expiration of their certification may appeal the denial but shall not receive benefits while awaiting the hearing decision.

F. A fair hearing will be held within 21 days of the request, unless delayed by mutual agreement of the parties.

G. The state agency shall provide 10 days advanced written notice of the date, time, and place of the hearing, which shall be held in the local agency at which the participant or applicant receives WIC Program services.

H. Pursuant to 7 CFR 246.9, the state or local agency shall provide the participant, applicant, or representative an opportunity to:

1. Examine, prior to and during the hearing, the documents and records presented to support the decision under appeal, which will be sent to the applicant or participant 10 days prior to the fair hearing;

2. Be assisted or represented by an attorney or other persons;

3. Bring witnesses;

4. Advance arguments without undue interference;

5. Question or refute any testimony or evidence, including an opportunity to confront and cross examine adverse witnesses; and

6. Submit evidence to establish all pertinent facts and circumstances in the case.

I. The hearing officer shall hear evidence and testimony and reach a decision. The state WIC director shall provide written notification of the hearing officer's decision to the applicant or participant and the district health director within 45 days of the date of the fair hearing request. Participants whose benefits were previously denied or discontinued may receive or reapply for WIC benefits upon receipt of a favorable decision by the hearing officer.

J. The local agency and state agency shall keep the results of the hearing on file for three years.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-190 Fair hearing request denial or dismissal

Per 7 CFR 246.9, the state and local agencies shall not deny or dismiss a request for a hearing unless:

1. The request is not received within the time limit set by the state agency;

2. The request is withdrawn in writing by the appellant or a representative of the appellant;

3. The appellant or representative fails, without good cause, to appear at the scheduled hearing; or

4. The appellant has been denied participation by a previous hearing and cannot provide evidence that circumstances relevant to program eligibility have changed in such a way as to justify a hearing.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009.

12VAC5-195-200 Program abuse and sanctions

A. The state agency determines program abuse and sanctions that may be issued to applicants and participants. When more than one abuse is involved at a time, the sanction shall be based on the more serious abuse.

B. If an abuse occurs more than 12 months after the last abuse, the local agency shall process the abuse as a first offense.

C. When more than three abuses in a 12-month period occur, the local agency shall issue a three-month temporary disqualification.

D. Program abuses and assigned sanctions are as follows:

| | Abuse | Number of Offenses | Sanction | | --- | --- | --- | --- | | | Class I | | | | | Any deliberate misrepresentation of income, name, residence, family size, medical data, or date of birth to obtain WIC benefits | All | Three-month disqualification | | | Dual participation – redeeming food instruments from two programs or agencies in same month | All | One-year disqualification | | | Assessed claim for $100 or more | All | One-year disqualification | | | Assessed second or subsequent claim for any amount | 2nd or subsequent | One-year disqualification | | | Attempting to steal or actually stealing food instruments from the local agency or another participant | All | Three-month disqualification | | | Selling, exchanging or giving away food instruments, food, or formula | All | Three-month disqualification | | | Redeeming WIC food instruments reported as lost or stolen | All | Three-month disqualification | | | Attempting to redeem or redeeming WIC food instruments for nonfood items (i.e., diapers, wine, cigarettes) | All | Three-month disqualification | | | Physically abusing the WIC or retailer staff (An incidence of physical abuse of WIC or retailer staff or properties should be reported to the police) | All | Three-month disqualification | | | Accepting cash or credit from a retailer in connection with a WIC transaction | 1st | One-month disqualification | | | 2nd | Two-month disqualification | | | | 3rd | Three-month disqualification | | | | Class II | | | | | Creating a public nuisance at the local agency or the retailer (i.e., verbally abusing, harassing, or threatening WIC or retailer staff, destroying retailer merchandise, or disrupting normal local agency or retailer activities) | 1st | Warning letter | | | 2nd | Two-month disqualification | | | | 3rd | Three-month disqualification | | | | Attempting to redeem or redeeming WIC food instruments for unauthorized food, formula, or food amounts | 1st | Warning letter | | | 2nd | Two-month disqualification | | | | 3rd | Three-month disqualification | | | | Allowing unauthorized persons to use the WIC ID Folder to pick-up or redeem WIC food instruments | 1st | Warning letter | | | 2nd | Two-month disqualification | | | | 3rd | Three-month disqualification | | | | | | | | | Redeeming WIC food instruments before or after valid spend dates | 1st | Warning letter | | | 2nd | One-month disqualification | | | | 3rd | Two-month disqualification | | | | Attempting to redeem or redeeming food instruments at unauthorized retailers | 1st | Warning letter | | | 2nd | One-month disqualification | | | | 3rd | Two-month disqualification | |

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 29, Issue 12, eff. March 13, 2013; Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-210 Collection of improperly issued instruments or claims against participants

The state agency shall establish a claim against a participant for the full value of benefits improperly obtained or disposed of as a result of a participant violation. Participant violations include:

1. Inaccurate certification information;

2. Dual participation violations;

3. Violation of the WIC guidelines or rules by the proxy or caretaker; or

4. Redemption of future food instruments after disqualification.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 29, Issue 12, eff. March 13, 2013; Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-220 Interruption of benefits

A. The state agency may discontinue benefits to participants due to funding shortages.

B. Local agencies shall only implement an interruption of benefits as specified by written direction from the state agency.

C. The state agency shall exercise its federal authority to limit participation to high priorities in the case of funding shortages.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008.

12VAC5-195-230 Conflict of interest

A. Local agency personnel involved in the WIC eligibility, certification, and food benefits process shall not:

1. Act as a proxy for a participant;

2. Have a direct financial interest in an authorized WIC retailer; or

3. Complete an onsite stocking visit of an authorized retailer at which they or a relative is employed.

B. Individuals involved in administering the WIC Program shall not certify or issue food instruments to themselves or relatives.

C. Additional conflict of interest regulation may be found in 12VAC5-195-460.

D. This section is not meant to replace or abrogate the Virginia State and Local Government Conflict of Interests Act, Chapter 31 (§ 2.2-3100 et seq.) of Title 2.2 of the Code of Virginia.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 29, Issue 12, eff. March 13, 2013; Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-240 Emergency situations

Local agencies shall follow emergency procedures in the event of an emergency situation. Procedures to continue WIC benefits shall be incorporated by the local agency into the district office's emergency and business recovery plan.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-250 (Reserved)

Historical Notes

Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008.

12VAC5-195-260 (Reserved)

Historical Notes

Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008.

12VAC5-195-270 (Reserved)

Historical Notes

Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008.

Part III Retailer Requirements

12VAC5-195-280 Enrollment procedures

A. The state agency shall accept applications from new retailer applicants year round.

B. Retailers seeking authorization shall comply with 7 CFR 246.12 and sell a range and variety of staple foods and WIC-approved formulas at a permanent fixed location, as specified in the retailer agreement and application package. Only one authorization approval will be granted by the state agency to each eligible location selected for program authorization. Stand-alone pharmacies and any other types of entities that cannot meet all of the general requirements outlined in this section shall be denied WIC Program authorization.

C. Retailer applicants shall complete the following requirements to become authorized for WIC Program participation:

1. Submit all applications, including pricing updates, using an electronic, Internet-based method that has been approved by the WIC Program;

2. Submit prices for all mandatory food and formula items, a signed retailer agreement, supplemental informational form, direct deposit automated clearinghouse (ACH) form, and other required forms as deemed necessary to evaluate an applicant's qualifications;

3. Pass a competitiveness price assessment completed by the WIC Program. The state agency shall determine whether the prices submitted as part of the new retailer application process are price competitive when compared to other retailers located in the retailer's assigned peer group;

4. Provide documentation to the state agency, upon request, that a satisfactory business integrity record exists. None of the retailer's current owners, officers, or managers shall have been convicted of or had a civil judgment entered against them for conduct demonstrating a lack of business integrity, within the past six years;

5. Pass an unannounced onsite visit to determine if the retailer has met the minimum stocking requirement, has available for sale the variety and selection of foods as stated on the supplemental informational form, and has posted prices that are not higher than prices submitted as part of the application process. The visit shall also verify that the retailer's hours of operation and number of cash registers were accurately reported;

6. Pass an onsite visit to determine if the type and variety of foods sold would qualify the retailer to earn more than 50% of its annual sales solely from the WIC Program. If the retailer is likely to be an above 50% retailer, then it shall be denied authorization;

7. Attend a mandatory new retailer training session conducted by either state agency staff or a certified corporate trainer within 30 calendar days after the retailer passes an unannounced stocking and price verification visit. Provide documentation to the state agency within 30 calendar days after meeting all other enrollment requirements that this mandatory training has been completed;

8. Provide training to retailer personnel and cashiers on proper WIC food instrument handling procedures;

9. Return to the state agency all required paperwork within 14 days after receipt including a signed retailer agreement, if applicable; supplemental informational form; direct deposit ACH form; and other information deemed necessary to evaluate a retailer's or applicant's qualifications; and

10. Receive from the state agency a packet containing an authorization acknowledgement letter granting WIC Program authorization, a retailer manual for the Virginia WIC Program, and a WIC window decal.

D. Newly authorized retailers shall begin accepting WIC food instruments within 15 calendar days after receiving their final acknowledgment letter. Authorized retailers are required to contact the state agency in writing if the retailer is unable to meet this program requirement. Failure to begin accepting WIC food instruments within the established time frame may lead to the state agency withdrawing its authorization decision.

E. Retailer applicants that fail to meet any of the enrollment requirements outlined in this section shall be denied authorization unless the state agency determines that inadequate participant access would exist if the authorization were terminated.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 29, Issue 12, eff. March 13, 2013; Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-290 Communications

A. Authorized retailers shall contact the state agency or their assigned agency representative rather than local WIC agency staff for all questions related to WIC Program participation including, retailer selection and authorization requirements and decisions, reimbursement questions, participant's food instrument prescriptions, and complaints.

B. Authorized retailers shall provide at least 15 calendar days written notice if the retailer decides to terminate its participation in the WIC Program or if the retailer ceases operation, changes ownership, or for any other circumstances that impacts service delivery including relocations, renovations, or temporary closures.

C. The state agency shall regularly communicate policy and procedural changes, training issues, WIC food instrument processing tips, cashier reminders and alerts affecting retailers in an informational newsletter. A newsletter shall be published annually and sent to all authorized retailers to update retailer personnel on major program changes. The state agency shall post approved policy changes, if applicable, on its external webpage. Authorized retailers shall comply with all policy changes communicated in writing by the state agency.

D. Written correspondence retained in the state agency's centralized files located in Richmond, Virginia, pertaining to a retailer's authorization status, application documentation, or WIC and Supplemental Nutrition Assistance Program compliance history is confidential and is protected by federal regulations (7 CFR 246.26). The state agency shall maintain retailers' compliance history and background information for at least a three-year period or the contract period, whichever is longer. For civil judgments and Supplemental Nutrition Assistance Program administrative documentation issued against a specific authorized retailer, the state agency shall retain this documentation for six years.

E. In order to utilize the WIC-approved, Internet-based application for submission of prices, retailers shall consent to be monitored by the Virginia Department of Health or its information technology agency to ensure that this application is used for its intended purpose. If monitoring reveals possible evidence of unauthorized or criminal activity, this evidence may be provided to local, state, or federal authorities for disciplinary action and prosecution to the fullest extent permitted by law.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 29, Issue 12, eff. March 13, 2013.

12VAC5-195-300 General requirements and conditions for authorization

A. Once enrolled, a retailer or applicant shall obtain authorization from the state agency to operate as a WIC-authorized retailer before accepting or redeeming food instruments.

B. To obtain and retain authorization, retailers shall:

1. Be Supplemental Nutrition Assistance Program authorized at the time of application or reauthorization and remain in good standing;

2. If applicable, fulfill the WIC disqualification requirement;

3. Be in operation as a business at the time of application or within 45 calendar days of application;

4. Comply with all local, state and federal statutes, regulations, and rules, including sanitation and building code regulations;

5. Submit prices using an electronic, Internet-based method when requested by the state agency;

6. Remain price competitive when compared to other authorized retailers that are located in the same peer group;

7. Meet the mandatory minimum stocking requirement at all times and keep such stock immediately available in the customer shopping area or onsite;

8. Operate at the retailer address indicated in the state agency's application or authorization record; this address shall be the sole location at which WIC customers purchase supplemental foods and formulas;

9. Be open for business at least 50 hours per week;

10. Meet all business integrity criteria as defined in 7 CFR 246.12;

11. Provide supporting documentation to the state agency including annual food sales information or tax records that will be used to ensure that no more than 50% of the retailer's total food sales were derived from WIC sales;

12. Comply with all corrective actions identified during prior WIC authorizations and pay all civil monetary penalties, if applicable;

13. Purchase contract and special formula from a distributor, supplier, wholesaler, or retailer who is approved by the Virginia WIC Program to sell formula; and

14. Participate in the WIC Program's direct deposit ACH process used for reimbursement and collection purposes.

C. Retailers shall not offer drive-through window or home delivery services for WIC purchases. The participant must take physical possession of purchased food and formula items at the time of transaction when the WIC food instrument is redeemed.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 29, Issue 12, eff. March 13, 2013; Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-310 Retailer screening for food sales above 50%

A. The state agency shall not authorize any applicant or retailer that is likely to derive 50% or more of its annual food sales from the sale of supplemental foods to WIC participants. Retailers already authorized by the program whose annual WIC food sales rise to 50% or more of their total food sales will have their authorization status terminated. Retailers must submit documentation that permits the state agency to complete its evaluation and identification of above 50% retailers. Failure to submit the requested documentation may lead to the retailer's authorization being terminated.

B. The state agency shall reassess the status of new retailers within six months after authorization to determine whether or not the retailer is above 50% (7 CFR 246.12).

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 29, Issue 12, eff. March 13, 2013; Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-320 Retailer agreement

A. The retailer agreement does not constitute a license or a property right. If an authorized retailer wishes to continue to be authorized beyond the current agreement period, the retailer must reapply for authorization. All retailers must be selected under the current selection and authorization criteria being used by the state agency (7 CFR 246.12).

B. Authorized retailers shall use a single uniform retailer agreement. The maximum duration of the retailer agreement shall not exceed three years. The duration of the retailer agreement may be for a period that is less than three years, as all agreements expire at the same time; therefore, prorated dates will be used.

C. A fully executed retailer agreement must be signed by both the authorized retailer representative and a WIC program management representative to be enforceable. The state agency shall provide the retailer or its designated contact person a copy of the signed retailer agreement or authorization acknowledgement letter after all selection and authorization requirements have been met.

D. An authorized retailer must have a signed copy of the retailer agreement for any retailer to be paid for a redeemed WIC food instrument.

E. Revisions, amendments, or modifications to the provisions of the retailer agreement shall be made in writing. The retailer agreement shall be automatically amended upon written notice from the state agency if federal or state laws or regulations require amendments.

F. Authorized retailers shall keep a copy of the updated retailer manual, including a copy of the WIC Approved food list, formula flyer, and Cashier Training Guide, at the authorized retailer location.

G. If a retailer appeals an administrative action imposed by the state agency against a retailer and the retailer agreement would otherwise expire during the appeal process, then the state agency shall grant an extension of that retailer's retailer agreement during the pendency of the appeal process. Once an appeal decision has been made, the state agency will proceed with either terminating the existing agreement or issuing a new agreement.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 29, Issue 12, eff. March 13, 2013; Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-330 Adequate participant access

The state agency shall ensure that adequate participant access exists so that eligible participants may redeem the food instruments issued to them. The state agency has the sole authority to establish adequate participant access criteria, which are described in 12VAC5-195-370.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 29, Issue 12, eff. March 13, 2013.

12VAC5-195-340 Competitive pricing

A. Authorized retailers and applicants shall submit pricing information to the state agency. Item pricing data is obtained from authorized retailers and applicants using prices that have been entered into a WIC-approved Internet-based application.

B. The state agency shall collect pricing information for specific food items at least twice a year (7 CFR 246.12). Prices may be collected more frequently from authorized retailers for reasons including:

1. A retailer's prices are determined to be noncompetitive;

2. A retailer is designated as a high-risk retailer;

3. An administrative review is being conducted as part of a compliance investigation, onsite monitoring visit, participant access analysis, inventory audit, or post payment analysis; or

4. Other operational considerations that may occur including a change of contract formula company, a change of infant food company, food industry price fluctuations, and manufacturer's price increases for selected WIC-approved products, such as baby foods, contract formula, and infant cereal.

C. Retailers and applicants must submit the highest shelf price for all mandatory foods and formula brands, unless stated otherwise, that are available and eligible to be sold to participants. For milk items only, retailers must submit the price for their WIC designated brand. All prices submitted via the Internet-based application shall be used for calculating the reimbursement maximums. Retailers must use the approved food list and the minimum stocking requirement to identify all eligible brands and foods.

D. Retailers failing to submit their prices within 14 days of the due date stated in the retailer manual shall receive one warning letter. After receiving the letter, retailers that fail to respond within the time period stated in the letter may have their WIC Program authorization terminated unless the state agency determines that inadequate participant access would exist if the retailer's authorization were terminated.

E. Applicants whose prices are determined to be noncompetitive when compared with other authorized retailers in the same peer group shall be denied WIC Program authorization. These applicants shall not be given a second opportunity to resubmit their prices unless the state agency determines that inadequate participant access would exist if the application was not considered.

F. Authorized retailers whose prices are determined to be noncompetitive when compared with other retailers assigned to the same peer group shall be given one opportunity to resubmit their prices. After analyzing the prices submitted from this second submission, the state agency shall determine if the retailer qualifies to remain authorized. The state agency shall terminate the retailer's authorization if its prices are noncompetitive unless the state agency determines that inadequate participant access would exist if the retailer's authorization were terminated.

G. The applicant's physical retailer address shall be classified as being located either in an urban or rural location based on the county or city where the retailer is located. Retailer applicants located outside of Virginia shall be assigned to the rural category.

| Rural Areas¹ | Cities: Norton, Suffolk Counties: Accomack, Albemarle, Alleghany, Amelia, Amherst, Appomattox, Augusta, Bath, Bedford, Bland, Botetourt, Brunswick, Buchanan, Buckingham, Campbell, Caroline, Carroll, Charles City, Charlotte, Clarke, Craig, Culpeper, Cumberland, Dickenson, Dinwiddie, Essex, Fauquier, Floyd, Fluvanna, Franklin, Frederick, Giles, Gloucester, Goochland, Grayson, Greene, Greensville, Halifax, Hanover, Henry, Highland, Isle of Wight, King and Queen, King George, King William, Lancaster, Lee, Louisa, Lunenburg, Madison, Mathews, Mecklenburg, Middlesex, Montgomery, Nelson, New Kent, Northampton, Northumberland, Nottoway, Orange, Page, Patrick, Powhatan, Pittsylvania, Prince Edward, Prince George, Pulaski, Rappahannock, Richmond, Rockbridge, Rockingham, Russell, Scott, Shenandoah, Smyth, Southampton, Spotsylvania, Surry, Sussex, Tazewell, Warren, Washington, Westmoreland, Wise, Wythe | | --- | --- | | Urban Areas¹ | Cities: Alexandria, Bedford, Bristol, Buena Vista, Charlottesville, Chesapeake, Clifton Forge, Colonial Heights, Covington, Danville, Emporia, Fairfax, Falls Church, Franklin, Fredericksburg, Galax, Hampton, Harrisonburg, Hopewell, Lexington, Lynchburg, Manassas, Manassas Park, Martinsville, Newport News, Norfolk, Petersburg, Poquoson, Portsmouth, Radford, Richmond, Roanoke, Salem, Staunton, Virginia Beach, Waynesboro, Williamsburg, Winchester Counties: Arlington, Chesterfield, Fairfax, Henrico, James City, Loudoun, Prince William, Roanoke, Stafford, York | | ¹The state agency uses the Isserman model for determining what cities and counties are considered urban and rural settings. This model was created for the U.S. Department of Agriculture and was published in "In the National Interest: Defining Rural and Urban Correctly in Public Policy" (International Regional Science Review, 28, 4:465 - 499 (2005)) | |

Authorized retailers are assigned to a peer group based on their designation of rural or urban and the number of cash registers located in the retailer. Peer groups are defined as follows:

| Peer Group | Description | Location | | --- | --- | --- | | 06 | Special formula contractor | Other | | 50 | One to four cash registers | Rural | | 51 | Five to nine cash registers | Rural and under $100,000 in annual WIC sales | | 52 | Five to nine cash registers | Rural and over $100,000 in annual WIC sales | | 53 | 10 and above cash registers | Rural | | 60 | One to four cash registers | Urban | | 61 | Five to nine cash registers | Urban and under $100,000 in annual WIC sales | | 62 | Five to nine cash registers | Urban and over $100,000 in annual WIC sales | | 63 | 10 and above cash registers | Urban |

H. For newly authorized retailers and applicants, the peer group designation assigned during the first three months shall be determined by the retailer's location and number of cash registers. For the peer group designation of newly authorized retailers that have five to nine cash registers, the state agency shall assume the retailer had less than $100,000 in annual WIC sales.

I. All retailers that have five to nine cash registers shall have their WIC sales data calculated by the state agency every six months to determine if the retailer's annual WIC sales are projected to be under or over $100,000. If the retailer's WIC sales have changed, then the retailer's assigned peer group shall change to reflect its redemption status.

J. Retailers that increase or decrease the number of cash registers must notify the state agency in writing within 15 calendar days. An onsite visit may be conducted by the state agency to confirm the number of operational cash registers. Retailers that knowingly misrepresent the number of cash registers may have their authorization status terminated unless the state agency determines that inadequate participant access would exist if the retailer's authorization were terminated.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 29, Issue 12, eff. March 13, 2013; Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-350 Price verification

A. Authorized retailers and applicants must submit prices for all mandatory foods and formulas as defined by the state agency. Once prices have been submitted to the WIC Program, they must remain in effect for at least a 30-day period and are subject to random onsite verification by the state agency. Posted prices that are significantly higher than the prices submitted to the state agency may affect the retailer's or applicant's authorization selection status.

B. A retailer or applicant's submitted price shall be compared by the state agency to other authorized retailer in the same peer group to determine if the prices submitted are competitive. Prices shall be submitted and validated as competitive for specific food items and formulas as specified in the retailer manual.

C. Authorized retailers and applicants shall have a pricing point value that is 40 or higher in order to remain eligible for program authorization.

| Description | Price Comparison Range | Pricing Point Value | | --- | --- | --- | | Best Pricing | Peer Group Average, minus 10% or more | 100 | | Highly Competitive | Peer Group Average, minus 5.1 - 9.9% | 80 | | More Competitive Pricing | Peer Group Pricing Average, plus or minus 5.0% | 60 | | Competitive | Peer Group Pricing Average, plus 5.1 - 19.9% | 40 | | Noncompetitive | Peer Group Pricing Average, plus 20% or higher | 20 |

D. Authorized retailers whose prices are identified as noncompetitive when compared with other authorized retailers in the same peer group may have their WIC Program authorization terminated unless the state agency determines that inadequate participant access would exist if the retailer's authorization were terminated.

E. Authorized retailers that fail to submit a price for optional food and formula items may have redeemed food instruments selected as ineligible for payment as part of the post-payment review process. The improperly redeemed food instruments may be identified as a retailer claim and may be subject to repayment of the full amount paid for all of the items prescribed on the food instrument.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 29, Issue 12, eff. March 13, 2013; Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-360 Selection decisions

A. Every three years, currently authorized retailers shall reapply for WIC program authorization. Retailers must meet all general requirements for authorization as established in 12VAC5-195-300.

B. The state agency shall review the qualifications of retailer applicants before making authorization selection decisions. Mandatory women and infant food and formula items sold at authorized retailers and retailer applicants shall be used for pricing analysis purposes. Authorized retailers and applicants must qualify under the price competitive category of 40 or higher in order to be selected for authorization.

C. If a retailer or applicant is not selected for program authorization, then the retailer may not apply again during the six months after being denied authorization. The state WIC director or designee may grant exceptions to the six month requirement if inadequate participation would exist if the retailer's authorization was not considered.

D. The state agency shall send all authorized retailers and applicants a written notice of their selection status. All retailers and applicants denied WIC Program authorization shall also receive information that explains their right to appeal the state agency's administrative decision.

E. The state agency shall not maintain an applicant waiting list.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 29, Issue 12, eff. March 13, 2013.

12VAC5-195-370 Authorization exception decisions

The state agency may make authorization exceptions to ensure that adequate access exists based on at least one of the following criteria:

1. Provide reasonable access;

2. Provide safe access due to a physical barrier or impediment including a multilane highway, river, bridge, or physical terrain (i.e., mountains);

3. Provide best pricing or a highly competitive alternative retailer location to eligible participants to purchase WIC-approved foods, when compared to other available retailers located within a given city or county;

4. Promote competition in a trade area previously identified as not having a price competitive authorized retailer location available;

5. Improve customer service or remove an existing service barrier (i.e., language, cultural);

6. Improve WIC customer access because the retailer is within a safe and reasonable walking distance and is located in close proximity to one or several low income housing units where WIC participants reside;

7. The retailer's draw area is broader than the retailer's immediate trade area. The retailer's draw area includes cities and counties that cross geographical boundaries; or

8. Expand access to WIC eligible foods that are purchased by a specific ethnic population.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 29, Issue 12, eff. March 13, 2013; Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-380 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; repealed, Virginia Register Volume 25, Issue 22, eff. July 6, 2009.

12VAC5-195-390 Approved food list

A. A copy of the current Virginia WIC Program's approved food list and formula flyer must be stored at each cash register where WIC transactions are handled. A copy of the approved food list and formula flyer must also be stored in the retailer manual kept onsite at the authorized retailer location.

B. The approved food list shall be used in conjunction with the WIC food instrument to identify foods that are eligible for purchase using WIC food instruments. The food instrument may state a specific food category and quantity available for purchase by program participants at authorized retailers.

C. The formula flyer shall be used in conjunction with the WIC food instrument to identify formula and medical foods that are eligible for purchase using WIC food instruments. The food instrument shall state the specific manufacturer, type, and quantity of formula that must be purchased by program participants.

D. Authorized retailers shall sell WIC-designated brands for food categories identified in the approved food list. Authorized retailers shall use shelf labels approved by the state agency to identify the WIC-designated brands in accordance with the state's shelf label requirement guidelines.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 26, Issue 10, eff. January 18, 2010; Volume 29, Issue 12, eff. March 13, 2013; Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-400 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 29, Issue 12, eff. March 13, 2013; repealed, Virginia Register Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-410 Change of ownership

A. Authorized retailers shall provide the state agency with advance written notice at least 15 calendar days prior to any change of ownership as outlined in 7 CFR 246.12.

B. A change of ownership occurs when the principal owner, owners, or corporate officers of the business or corporation are legally or permanently changed.

C. A retailer's authorization shall be terminated by the state agency upon a change of ownership. The rights and obligations established under a signed retailer's agreement with the WIC Program may not be transferred or reassigned by the retailer or corporate owner to any other third party.

D. The new owner or retailer manager of the business or corporation shall apply for WIC Program authorization and submit a new application for evaluation based on the most current retailer selection and authorization criteria.

E. The state agency shall terminate the authorization status of any retailer that has undergone a change of ownership and failed to notify the state agency in accordance with the requirements outlined in the signed retailer agreement.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 29, Issue 12, eff. March 13, 2013; Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-420 Change of location

A. Authorized WIC retailers shall provide the state agency with written notice of a retailer's relocation plans within 15 calendar days prior to scheduled move date. Failure to notify the state agency in writing of such actions may result in the state agency taking administrative action, including terminating for cause the retailer's program authorization, unless the state agency determines that inadequate participant access would exist if the authorization were terminated.

B. Relocation of a retailer is defined as:

1. The retailer's physical location changes within the same geographical area or county/city and there is no change in ownership or pricing structure. The retailer must meet one of the following criteria:

a. New retailer location is two miles or less from the former location; or

b. Majority of management and retailer personnel will move to the new location. If the new location is greater than two miles, the WIC Program will evaluate on a case-by-case basis to determine whether the new location is an alternative location and qualifies as a relocation versus a new retailer authorization;

2. The retailer shall be open for business within 15 calendar days or less after moving to a different physical location; and

3. The former retailer location under the existing owner shall be permanently closed for business.

C. The state agency shall ensure that the new location still meets the selection criteria as outlined in 12VAC5-195-340 and 12VAC5-195-360 including being price competitive. Failure to meet all selection criteria may lead to the retailer's authorization being terminated unless the state agency determines that inadequate participant access would exist if the authorization were terminated. Authorized retailers that meet all selection criteria will be permitted by the state agency to continue their authorization without experiencing any disruption in their authorization status. The state agency must assign a new WIC authorization ID to the new retailer location if a new Supplemental Nutrition Assistance Program ID has been issued to the retailer.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 29, Issue 12, eff. March 13, 2013.

12VAC5-195-430 Change due to closure

A. Authorized retailers shall give the state agency written notice of a retailer's permanent or temporary closure within 15 calendar days before the actual closing date. A temporary closure is defined as a retailer location being closed to the public for more than 15 consecutive calendar days. Retailers closed to the public for any reason greater than 30 consecutive calendar days will have their WIC Program authorization terminated.

B. Failure to notify the state agency in writing of either permanent or temporary closure may result in the state agency taking administrative action, including terminating for cause the retailer's WIC authorization status.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 29, Issue 12, eff. March 13, 2013.

12VAC5-195-440 Voluntary withdrawal

Authorized retailers shall give the state agency at least 15 calendar days written notice if the retailer owner or manager decides to discontinue participation in the Virginia WIC Program.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 29, Issue 12, eff. March 13, 2013.

12VAC5-195-450 Complaints

A. The state agency shall maintain a system of receiving, documenting and investigating all complaints submitted by retailers, participants, proxies, caretakers, parents, and the general public. On the basis of a written complaint, the state agency may take action against participants and retailers that abuse or misuse program benefits as outlined in the State Plan and retailer manual.

B. The state agency shall forward complaints of both alleged discrimination and civil rights violations to the Secretary of Agriculture as required by 7 CFR Part 246.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 29, Issue 12, eff. March 13, 2013; Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-460 Conflict of interest

A. Authorized retailer management shall seek to ensure that no conflict of interest exists between any retailer personnel employed by the retailer and any local, state, or federal WIC agency. The prohibition against conflict of interest applies to retailer employees, retailer owners, or relatives of retail employees or owners who are also employees of a local, state, or federal WIC agency.

B. WIC participants, caretakers, or proxies who are employed at an authorized retailer shall not accept or transact food instruments issued to themselves or relatives as a function of their duties at the retail location. Authorized retailer management shall ensure all retailer employees adhere to this integrity requirement.

C. Authorized retailer management shall notify the state agency in writing when a conflict of interest exists.

D. When an employee of an authorized retailer or an employee's relative is employed by a local, state, or federal WIC agency, the employee shall:

1. Notify retailer ownership or management of his or his relative's employment;

2. Not show favoritism towards any authorized retailer including the retailer where he is employed.

E. Employees of an authorized retailer shall not in their professional capacity provide any gratuities, including cash, food, coupons, or gift cards, to employees of local, state, or federal WIC agencies.

F. Authorized retailer management shall seek to ensure its employees comply with the conflict of interest requirements listed in this section and review them with retailer personnel annually.

G. Additional conflict of interest regulations may be found in 12VAC5-195-230.

H. This section is not meant to replace or abrogate the Virginia State and Local Government Conflict of Interests Act, Chapter 31 (§ 2.2-3100 et seq.) of Title 2.2 of the Code of Virginia.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 29, Issue 12, eff. March 13, 2013.

12VAC5-195-470 Incentives

Authorized retailers may not provide incentives to local agency staff or participants to entice or promote shopping at a specific retailer location, unless approved in writing by the state agency.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 29, Issue 12, eff. March 13, 2013.

12VAC5-195-480 Participant confidentiality

A. Participant information shall remain confidential to ensure compliance with federal regulations and to protect the right to privacy of WIC participants (7 CFR 246.26).

B. Confidentiality requirements apply to information provided by a participant and that is based on direct observation by retailer personnel. Confidentiality requirements include, but are not limited to:

1. The prohibition of retailers from collecting personal information from WIC participants;

2. Making personal contacts with WIC participants after the WIC transaction has occurred; or

3. Sharing information on participant identification with third parties. Third parties do not include WIC Program state, local and federal agency representatives who have a legitimate business interest in the services provided to participants.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 29, Issue 12, eff. March 13, 2013.

12VAC5-195-490 Retailer confidentiality

A. Background and pricing information collected by the state agency related to evaluating the authorization status of a retailer or collected from food instruments redeemed by an authorized retailer are confidential and may be released only as provided in 7 CFR 246.26.

B. In accordance with federal regulations, 7 CFR 246.26, confidential retailer information is any information about a retailer, whether it is obtained from the retailer or another source, that individually identifies the retailer, except for the following: retailer name, physical mailing address, telephone number, website, email address, retailer type, and authorization status. All other retailer specific information is restricted from disclosure by the state agency.

C. Upon receiving a written request from a retailer or its parent corporation, the state agency shall only release background and pricing information that has been provided by or that pertains to the requestor. Under no circumstances may the state agency release confidential information about the redemption revenue paid to retailers owned by other corporations.

D. Authorized retailers' peer group designation is confidential and is restricted from disclosure to persons and entities not directly associated with the authorized retailer location.

E. The state agency's inadequate participant access results completed for administrative purposes are considered confidential and not subject to review by the retailer or its agent, since this profile contains information protected by WIC Program regulations. Upon request, a copy of this work document may be released with all confidential information removed. This document in its entirety shall be made available to appropriate governmental bodies that are responsible to ensure that the state agency has fully complied with any mandated WIC Program requirements.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 29, Issue 12, eff. March 13, 2013.

12VAC5-195-500 Sales tax and coupons

A. Authorized retailers shall ensure that no sales tax is charged to the WIC Program. Retailer coupons, manufacturercoupons and loyalty card discounts may be used for WIC-approved purchases. When a WIC participant uses a coupon or discount card in conjunction with a food instrument and an item is provided free, then sales tax shall be collected directly from the participant.

B. No sales tax can be applied to the printed value of cash value food benefits. Any tax associated with the dollar amount purchased above the printed value of the cash value food benefit must be collected directly from the participant.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 29, Issue 12, eff. March 13, 2013.

12VAC5-195-510 Solicitation

A. Authorized retailers shall not:

1. Initiate behavior that may be deemed aggressive or intimidating by a reasonable person in approaching potential WIC participants in order to promote that participant's shop at a specific retailer location; or

2. Use any state or local agency facilities and property to post or distribute materials advertising their retailer location.

B. If the state agency documents that an authorized retailer violates either of these prohibitions, then the retailer's authorization may be subject to termination by the program.

C. Authorized retailers shall not use any advertisement practices or procedures that may give the public or participants the impression that a special or exclusive business relationship exists between the state agency and any authorized retailer.

D. It is the retailer owner's or designated agent's responsibility to ensure all employees understand and adhere to all prohibitions and restrictions related to solicitation.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 29, Issue 12, eff. March 13, 2013.

12VAC5-195-520 Training and education

A. Training of applicants or authorized retailers may be conducted by state agency staff. The state agency may also delegate authority to trained individuals who have been certified as corporate trainers. Certified corporate trainers shall attend mandatory WIC training as required in order to remain certified.

B. The state agency shall provide mandatory annual training for previously authorized retailers. The annual training requirement may be met by the previously authorized retailers:

1. Submitting a newsletter training acknowledgement form;

2. Successfully completing an agency-sponsored Internet training course offered by the WIC Program; or

3. Attending an approved instructor-led, interactive training class.

C. Reauthorization training shall be required for previously authorized retailers that have been selected under a new contract period.

D. Authorized retailers may request remedial training at any time by contacting the state agency.

E. All authorized retailers are required to have at least one representative participate in annual training provided by either the state agency or a certified corporate trainer (7 CFR 246.12).

F. Failure of an authorized retailer to meet the mandatory training requirements shall result in sanctions being imposed and the possible termination of the retailer's program authorization, unless the state agency determines that inadequate participant access would exist if the authorization were terminated.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 29, Issue 12, eff. March 13, 2013; Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-530 Use of acronym and logo

A. Authorized retailers shall post a state-issued "WIC Accepted Here" window decal in the retailer's front entrance or in a conspicuously visible location that identifies to the general public that the retailer location participates in the WIC Program. Authorized retailers may use alternative signage if approved by the state agency prior to being used.

B. Retailers, food manufacturers, distributors and suppliers shall receive written approval from the state agency prior to producing or distributing window decals, channel strips, shelf talkers, or other promotional items that use either the WIC acronym or logo. Retailers that elect to use point-of-sale channel strips, shelf labels, or other promotional materials for a specific food category must ensure that all eligible items are consistently promoted as WIC approved. Retailers are prohibited from promoting a specific manufacturer's product over another eligible WIC-approved product within the same food category (USDA Memo SFP 09-020).

C. Retailers or applicants shall not use either the acronym "WIC," "W.I.C." or the WIC logo, including close facsimiles thereof, in total or in part, either in their official name in which the retailer is registered or in the name under which it does business, if different (USDA Memo SFP 09-020).

D. Retailers, food manufacturers, distributors and suppliers shall not use the WIC acronym or logo in the packaging of their products. Retailers, food manufacturers, distributors and suppliers shall receive written approval from the state agency before using either the WIC acronym or logo for any business or public relations purpose (USDA Memo SFP 09-020).

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 29, Issue 12, eff. March 13, 2013.

12VAC5-195-540 Retailer manual for the Virginia WIC Program

Periodically, individual sections of the retailer manual may be updated to reflect federally mandated regulatory changes and other WIC Program requirements. The most current version of the retailer manual is located on the state agency's website, which retailers must access to obtain updated copies of procedures and forms.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 29, Issue 12, eff. March 13, 2013; Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-550 High-risk retailers

A. A high-risk retailer is a retailer who has a high probability of committing a vendor violation due to meeting specific high-risk indicators. The state agency shall classify each authorized retailer as either high-risk, probationary, or non-high-risk.

B. The state agency will identify high-risk retailers at least once a year using criteria developed by FNS or other FNS-approved, statistically-based criteria developed by the state agency.

C. Any retailer receiving a WIC program civil monetary penalty and that is being retained in lieu of disqualification may be designated as high-risk.

D. Retailers are designated high-risk for a minimum one-year period and will have their status periodically evaluated by the state agency. Retailers found to meet high-risk indicators during the course of a year after the state conducts its annual high-risk vendor analysis may be identified as high-risk at the discretion of the state agency. Authorized retailers designated as high-risk may be selected for more frequent onsite and covert monitoring investigations.

E. If a retailer is retained in lieu of disqualification, a written assurance letter must be submitted to the state agency within 30 calendar days after being notified of this requirement or another mutually agreed upon timeframe made in writing. The retailer's assurance letter must detail the actions the retailer will take to improve performance.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 29, Issue 12, eff. March 13, 2013; Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-560 Non-high-risk retailers

Authorized retailers that have participated in the WIC Program for more than one continuous year and have demonstrated an acceptable level of compliance in meeting program requirements are considered non-high-risk retailers.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 29, Issue 12, eff. March 13, 2013; Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-570 Probationary retailers

Newly authorized retailers with less than one year of continuous program authorization shall be designated as a probationary retailer. During a probationary retailer's first year, the retailer will be more frequently monitored through both unannounced and onsite monitoring visits, as well as being selected for at least one compliance investigation.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 29, Issue 12, eff. March 13, 2013; Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-580 Performance and administrative monitoring

A. All applicants must successfully pass an unannounced stocking visit prior to being authorized. Applicants shall receive a written letter from the state agency advising them that their retailer has been selected for further authorization consideration, which will include an unannounced stocking visit. The applicant shall receive a copy of the minimum stocking requirement and the letter shall identify the consequences of failing to meet this program standard.

B. The state agency shall monitor authorized retailers' performance throughout the contract period in order to ensure the best qualified retailers are authorized. The type and level of monitoring conducted by the state agency shall depend upon the retailer's authorization status. Trained local agency staff, state agency staff, and other specially trained contractors may conduct onsite visits to ensure compliance with minimum stocking requirements and administrative program requirements. Retailers designated as high-risk retailers and probationary retailers are more likely to be selected for unannounced monitoring visits by the WIC Program.

C. Authorized retailers that fail to consistently comply with any of the general requirements and conditions for authorization may be terminated. The state agency shall monitor:

1. Prices charged for WIC-approved foods and formula;

2. Level of compliance with program requirements;

3. Use of approved wholesalers and suppliers for purchasing WIC-approved foods and formulas; and

4. Compliance with retaining purchasing records for WIC-approved foods and formulas.

D. The state agency shall establish and communicate the minimum stocking requirement to all authorized retailers and applicants.

E. Each federal fiscal year, a sample of authorized retailers shall be selected for one or more unannounced onsite monitoring visits.

F. Agency representatives may conduct an unannounced monitoring visit to ensure that authorized retailers or applicants meet all program requirements. Authorized retailers and applicants shall have the minimum stocking requirement available onsite at all times. The required specific foods, contract formulas, and administrative procedures are outlined in the minimum stocking requirement in the retailer manual.

G. Agency representatives shall conduct unannounced monitoring visits during hours the retailer is open to the public. Authorized retailers must submit any changes to their normal hours of operation to the state agency in writing.

H. The state agency may conduct other types of unannounced onsite monitoring visits to a retailer's location including random, price verification, formula audits, purchased formula records review, and high-risk.

I. During an unannounced onsite monitoring visit, the state agency representative may:

1. Observe and document the level of compliance with general program requirements;

2. Validate if the minimum stocking requirement has been met;

3. Validate if administrative requirements have been met;

4. Collect and confirm prices submitted by retailers;

5. Confirm prices are posted on or in close proximity to WIC-approved foods;

6. Review purchase or invoice records;

7. Conduct formula inventory analysis;

8. Educate the retailer about program changes;

9. Provide educational materials and supplies;

10. Provide technical consultation;

11. Confirm WIC-approved shelf labels are being used correctly to identify WIC-designated brands; and

12. Confirm the number of reported cash registers.

J. During the unannounced onsite monitoring visits, retailer management may receive:

1. Answers to technical or procedural questions;

2. Updated program information;

3. Additional training materials and supplies;

4. Opportunity to correct documented deficiencies, if needed;

5. Opportunity to provide shelf prices of WIC-approved items, if applicable; and

6. Opportunity to confirm results documented by the state agency representative during the monitoring visit.

K. The results from these onsite visits are documented and kept on file at the state agency office in Richmond, Virginia.

L. Each federal fiscal year, a sample of authorized retailers shall be selected for one or more announced onsite formula monitoring visits. The state agency shall ensure that authorized retailers sell formulas that have been purchased from a WIC-approved supplier, distributor, wholesaler, or authorized resource. A listing of WIC-approved suppliers, distributors, wholesalers, and authorized resources is located on the state agency's website. State agency personnel shall review formula purchasing records and invoices, compare formula redemption data from WIC sales, and complete a prephysical and post-physical inventory of formula available at the retailer location during a specific analysis period. Retailers whose purchase records do not support the quantity of WIC sales volume for a selective formula item based upon redeemed food instruments may be issued sanctions, fined, or disqualified from the WIC Program. The results from a formula monitoring visit shall be documented and a written assessment shall be sent to the retailer once the state agency has completed its analysis.

M. Authorized retailers that do not remain price competitive, fail to maintain the minimum stocking requirement, or fail to adhere to the retailer agreement may be fined or have their authorization terminated unless the state agency determines that inadequate participant access would exist if the authorization were terminated. Depending upon the service delivery impact, the state agency may temporarily waive terminating a retailer that fails to comply with any of these requirements until an alternative retailer located in the same area can be authorized. The state agency shall document the reasons for making any authorization exception decisions.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 26, Issue 10, eff. January 18, 2010; Volume 29, Issue 12, eff. March 13, 2013; Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-590 Reimbursement and payments

A. For each processed food instrument, the state agency shall do one of the following:

1. Pay as submitted;

2. Make a price adjustment, if applicable; or

3. Deny payment of the redeemed food instrument.

B. The state agency's reimbursement responsibilities include:

1. Ensuring payments are made to authorized retailers that have a signed retailer agreement with the Virginia WIC Program. Unauthorized retailers will not be paid for any mistakenly accepted and deposited food instruments;

2. Ensuring the maximum reimbursement levels used by its banking contractor, based upon peer groups, are reasonable for the food and formula items prescribed for purchase by participants;

3. Making price adjustments to the reimbursement amount paid to retailers in order to ensure individual retailer's reimbursement levels remain eligible for authorization, based upon competitive prices charged by similar retailers;

4. Collecting bank account and routing numbers from applicants and authorized retailers in order to process direct deposit automated clearinghouse (ACH) payments;

5. Ensuring prompt ACH credits are made to the retailer's bank account when appropriate;

6. Collecting retailer's prices using an electronic, Internet-based application;

7. Identifying retailers whose prices are noncompetitive and take administrative actions including possible termination of the retailer's authorization;

8. Complying with all federal regulations and guidelines that require administrative approval by USDA prior to making payments, as applicable;

9. Providing written communications to all authorized retailers containing the procedures used by the program to pay or deny payments for all redeemed food instruments; and

10. Recouping overpayments due to banking or procedural errors, if applicable, from authorized retailers.

C. A not to exceed (NTE) amount for each peer group and UPC is established using sales data (7 CFR 246.12).

D. For cash value food benefits only, the retailer must offer one of the following options to the participant if the total dollar amount being purchased exceeds the printed cash value:

1. The participant shall be allowed to pay the amount over the printed cash value; or

2. The participant shall be allowed to reduce the quantity of eligible fruits and vegetables being purchased.

Retailers must notify the state agency in writing which of these options they provide to WIC participants.

E. The peer group and UPC NTE may be adjusted weekly by the state agency, depending upon external factors including wholesale price increases. The NTE used for the various peer group combinations is not distributed to authorized retailers prior to being used by the banking contractor.

F. The state agency shall use a post-payment review process to prospectively evaluate the reimbursement amount paid against redeemed food instruments in order to identify excessive or improperly redeemed food instruments in accordance with federal regulations (7 CFR 246.12). From the post-payment review process, the state agency may determine that one or more payments already made to a retailer were ineligible for payment as a result of a retailer failing to provide the cardholder with foods that were taken off the eWIC card. The state agency reserves the right to bill and recoup payments of these ineligible payments, which will be referred to as a retailer claim (7 CFR 246.12). The state agency shall not bill an authorized retailer if the retailer claim amount is less than $10.

G. A retailer that is not authorized to participate in the Virginia WIC Program that accepts a food instrument will not be reimbursed for any food instruments redeemed by a WIC participant.

H. A retailer must submit a direct deposit ACH form to the state agency that identifies any bank changes to its routing or account number. A direct deposit ACH form must be submitted at least 14 days prior to the change effective date. If the state agency's banking contractor identifies that the retailer's bank account or routing number is not valid, then the retailer will receive one written notice from the state agency. Failure by the retailer to resolve any reported discrepancies within 30 days after a written notice has been sent by the state agency may lead to the retailer being ineligible to receive payments for rejected food instruments.

I. Retailers are responsible for all bank handling fees and charges associated with doing business with the WIC Program.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 26, Issue 10, eff. January 18, 2010; Volume 29, Issue 12, eff. March 13, 2013; Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-600 Sanctions and administrative actions

A. Each federal fiscal year, the state agency shall conduct compliance investigations on a minimum of 5.0% of authorized retailers (7 CFR 246.12), including completing investigations of all high-risk retailers, all probationary retailers, and select non-high-risk retailers. The state agency will conduct at least two compliance buys at each retailer selected for an investigation.

B. The state agency shall provide written notification to the authorized retailer of the investigation results, including the retailer's violation of any statutes or regulations governing its participation in the WIC Program. Once an investigation has been closed, retailers with documented violations shall receive a final written report of the agency's findings. The final report will identify what administrative action shall be taken by the state agency against the authorized retailer.

C. Violations shall be categorized as either state agency or federally mandated. For federally mandated violations, a pattern consisting of four documented incidents of the same violation must occur during a single investigation unless a pattern requirement is not required by federal regulations.

D. For federally mandated violations including overcharge, fraud, trafficking in food instruments, selling firearms, ammunition, explosives, controlled substances, alcohol or alcoholic beverages, or tobacco products, the state agency may not provide the retailer with prior written notice that violations were documented before imposing administrative sanctions. This notification decision will be made on a case-by-case basis, depending on the type of federally mandated violation documented and if it is determined that notification would compromise the investigation.

E. The type of documented violation dictates the administrative action taken including:

1. Provision of a written warning;

2. Imposition of a technical penalty fine;

3. Assessment of a civil monetary penalty (CMP) in lieu of disqualification; or

4. Disqualification of an authorized retailer.

The total period of disqualification imposed for state agency violations identified as part of a single investigation may not exceed one year. The state agency reserves the right to waive a disqualification requirement if the state agency determines that inadequate participant access would exist if the authorization were terminated.

F. The state agency shall use a multitier sanction schedule that consists of:

| Class: | Description: | Description: | Administrative Actions: | | --- | --- | --- | --- | | A | Technical program violations | Represents procedural and food instrument handling errors. | $100 fine assessed per documented incident, as outlined in the Sanction/Violation schedule, including repeat incidents of the same violation, plus a written warning sent to the retailer. | | B | Serious program violations | Represents noncompliance errors documented by compliance investigations, inventory audits, or noncompliance with provisions outlined in the retailer agreement. | One-year disqualification for eight or more technical program violations, as outlined in the Sanction/Violation schedule, within a consecutive 12-month period of time; or One-year disqualification, if a pattern of noncompliance exists, as outlined in the Sanction/Violation schedule. | | C | Critical program violations | Represents mandatory federal sanctions that require a pattern of noncompliance, i.e., overcharging. | Four documented incidents during a single investigation as outlined in the Sanction/Violation schedule – Three-year disqualification; or One documented incident as outlined in the Sanction/Violation schedule during a single investigation if a pattern is not required – Three year disqualification. | | D | Major program violations | Represents mandatory federal sanctions, i.e., administrative finding of trafficking | Six-year disqualification – only one documented incident is required as outlined in the Sanction/Violation schedule; or Permanent disqualification – only one documented incident is required, as outlined in the Sanction/Violation schedule. | | E | Warning | Represents a documented violation, but does not warrant points being assessed or a fine being charged. | Written warning sent to the retailer. |

The date on which violations become effective is determined by the date indicated on the final compliance investigation letter. Class A, B, and E violations have an active life of one year, a Class C violation has an active life of three years, and a Class D violation has an active life of six years or permanent disqualification.

G. If, within a 12-month period, a retailer has three documented incidents of failure to meet the minimum stocking requirement, then the retailer shall be disqualified for a one-year period unless the state agency determines that inadequate participant access would exist if the authorization were terminated.

H. All documented overcharges or payments for ineligible food items identified during a compliance investigation shall be considered a retailer claim and be subject to repayment.

I. Copies of any investigative evidence collected by the state agency during a compliance investigation shall be available to the authorized retailer, upon request, after the investigation has been closed and the retailer is notified in writing of the final compliance investigation results.

J. A retailer may apply for WIC authorization after the retailer has finished the disqualification period. There is no automatic reinstatement of a retailer once the disqualification period has ended.

K. The state agency shall not issue sanctions solely as a result of complaints submitted by participants.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 29, Issue 12, eff. March 13, 2013; Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-610 Participant access

A. Prior to taking disqualification actions against an authorized retailer, the state agency shall complete a participant access assessment (7 CFR 246.12). This type of assessment is completed for denied authorizations if an informal settlement meeting or full administrative review is requested by a retailer applicant. Participant convenience is not a valid consideration for the state agencies in making any adequate access decisions.

B. Participant access will be a factor considered by the state agency in deciding if a retailer shall be assessed a civil monetary penalty in lieu of disqualification or when a retailer applicant is eligible as an authorization exception.

C. The state agency shall use the same criteria established for making authorization exceptions in deciding if adequate participant access exists.

D. The participant access analysis completed by the state agency contains confidential information. A copy of this internal work document shall not be given to retailers or their representatives.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 29, Issue 12, eff. March 13, 2013.

12VAC5-195-620 Participant impact

Participant impact may be an additional factor considered by the state agency in deciding if a retailer shall be assessed a civil monetary penalty in lieu of disqualification. For retailers whose average number of unique participants is deemed high may be retained in lieu of disqualification. The state agency will take into consideration customer service impact and competitive pricing issues in making any administrative exception decisions.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 29, Issue 12, eff. March 13, 2013.

12VAC5-195-630 Retained in lieu of disqualification

A. An authorized retailer with documented administrative findings that warrant WIC Program disqualification actions may be retained in lieu of disqualification if the state agency determines that inadequate participant access would exist. The state agency will evaluate the impact on participants and the preventive procedures the retailer intends to take in order to decide if the retailer will be allowed to pay a civil monetary penalty rather than being disqualified.

B. The state agency shall notify the authorized retailer in writing if it will be retained in lieu of disqualification and the civil monetary penalty that has been assessed (7 CFR 246.12).

C. If a retailer fails to pay a civil monetary penalty that has been assessed, the state agency shall disqualify the retailer for a period equal to the sanction for which the civil monetary penalty was originally assessed.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 29, Issue 12, eff. March 13, 2013.

12VAC5-195-640 Civil monetary penalties

A. A civil monetary penalty (CMP) may be assessed for documented state agency and federally mandated violations (7 CFR 246.12).

B. The state agency uses a federally mandated formula to calculate both state and federally mandated CMPs that are assessed. The maximum civil monetary penalty assessed shall comply with federal requirements as outlined in 7 CFR 246.12. The state agency cannot make any reductions to the maximum CMP amount due for federally mandated violations because this formula is defined in federal regulations.

C. The same formula shall be used to calculate the civil monetary penalty for retailers retained in lieu of disqualification due to documented state agency sanctions. For state agency violations only, the state WIC director or the director's designee has the authority to reduce or waive the penalty amount being assessed against the retailer. The state agency must document in its records the specific factors supporting this administrative decision.

D. A CMP may be paid in a lump sum or through an agreed upon installment plan. Failure of the authorized retailer to pay any scheduled installments in a timely manner shall lead to the retailer's disqualification for the original disqualification period.

E. Payments shall be made by certified check, cashier check, or money order. Payments shall be made out to the Virginia WIC Program and mailed to the address identified on the penalty fine statement.

F. The state agency shall process all past due obligations including administrative fines, retailer claims, civil monetary penalties, or overcharge repayments assessed against authorized retailers in accordance with the Office of the Comptroller's Policies and Procedures, Section Number 205000 (Accounts Receivable), dated August 2018. The state agency shall also process all past due financial obligations in accordance with the Virginia Debt Collection Act (§ 2.2-4800 et seq. of the Code of Virginia).

G. The state agency shall notify the Supplemental Nutrition Assistance Program in writing within 15 calendar days after assessing a CMP against an authorized retailer being retained in lieu of disqualification.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 29, Issue 12, eff. March 13, 2013; Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-650 Disqualification administrative actions

A. Voluntary withdrawal or nonrenewal in lieu of disqualification is not permitted for documented mandatory federal violations. The state agency may only allow voluntary withdrawal or nonrenewal for state agency sanctions.

B. The state agency shall disqualify an authorized retailer for any of the following reasons:

1. Failure to comply with general requirements and conditions as established in the retailer agreement;

2. Failure to meet program requirements as documented during the compliance investigation process;

3. Reciprocal administrative action due to the retailer being disqualified from the Supplemental Nutrition Assistance Program;

4. Failure to pay a CMP or retailer claim within 20 calendar days after it is due or failure to pay an installment plan payment when due;

5. Provision of false, incomplete, inaccurate, or misleading information that affects the retailer's selection status;

6. Repeated failure to maintain the minimum stocking requirement; or

7. Failure to take documented remedial corrective actions.

C. The state agency shall notify the Supplemental Nutrition Assistance Program office of any WIC Program disqualifications taken against an authorized retailer location.

D. If an authorized retailer is disqualified primarily due to documented overcharges, participates in a full administrative review, and the adjudication officer's findings confirm that the disqualification actions taken by the state agency are appropriate, then a fine shall be assessed. A maximum administrative fine of $999 shall be assessed for two or more documented overcharges during a single investigation. If only one overcharge incident was documented during a single investigation, then a maximum fine of $500 shall be assessed. If the disqualification action does not involve any documented overcharges, then no fine shall be assessed.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 29, Issue 12, eff. March 13, 2013.

12VAC5-195-660 Informal settlement meetings

A. If an authorized retailer is being considered for possible adverse action, including but not limited to authorization denial and program disqualification, the state agency shall offer an optional informal settlement meeting with retailer management prior to taking administrative action. The state WIC director or designee shall be in attendance. The purpose of the informal settlement meeting is to:

1. Identify areas of noncompliance;

2. Provide a forum for the retailer to submit information about the impact of the adverse action on WIC participants;

3. Review criteria for authorization exception decisions pursuant to 12VAC5-195-370;

4. Review the inadequate participant access results, if applicable;

5. Review the civil monetary penalty for retailers being retained in lieu of disqualification, if applicable; and

6. Provide information to the retailer regarding its appeal rights, if applicable.

B. The retailer or applicant has 15 calendar days from the date of receipt of the state agency correspondence to postmark a written request for an informal settlement meeting.

C. The request for the informal settlement meeting can be hand delivered, mailed by US mail, UPS, or FedEx, sent by facsimile transmission or sent via email to the state agency.

D. Upon receipt of the retailer's or applicant's request for an informal settlement meeting, the state agency will confirm a date, time, place and method for the informal settlement meeting.

E. All requests to reschedule the meeting must be submitted in writing at least 24 hours before the scheduled meeting date, unless an emergency occurs, as determined at the discretion of the state WIC director or designee.

F. If the retailer representative is more than 45 minutes late from the agreed upon meeting start time, then this will be considered a "no show" unless he can provide documentation that the state WIC director or designee determines justifies his tardiness or failure to appear. The state agency will proceed with administrative decisions without the input of the retailer should the representative either fail to schedule, fail to appear, or fail to reschedule the informal settlement meeting.

G. Informal settlement meetings are either conducted through face-to-face meetings in Richmond, Virginia, or via video conference. For informal settlement meetings that are held via video conference, the authorized retailer or applicant would be required to travel to a local agency that has videoconferencing equipment available.

H. After the informal settlement meeting is held and all supporting documentation is received by the state agency, the state agency shall send within 15 days a written summary of the meeting's results to a designated retailer representative. If the resolution offered from the informal settlement meeting is unacceptable to the retailer, then the retailer or applicant may request a full administrative review in writing. This written request must be submitted to the state agency and postmarked within 15 calendar days from the date of receipt of the informal settlement meeting summary. The state agency will identify if the retailer's request qualifies under federal regulations for a full administrative review. If the retailer's request is not eligible, then the retailer will receive a written response from the state agency of this decision.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 29, Issue 12, eff. March 13, 2013.

12VAC5-195-670 Full administrative review

A. Authorized retailers and applicants shall be offered an opportunity to request a full administrative review only for the adverse action cited in subsection O of this section.

B. The retailer or applicant has 15 calendar days from the date of receipt of the denial notice or the disqualification letter, either by letter or an electronic format, to request a full administrative review.

C. The request for the full administrative review may be mailed by U.S. mail, sent by facsimile transmission or sent via email to the state agency. If the request is mailed, it must be postmarked within 15 calendar days from the date of receipt of letter or electronic notification from the state agency, whichever comes first.

D. The retailer or applicant should indicate whether he intends to be represented by an attorney when the full administrative review request is made. This does not preclude the retailer or applicant from seeking legal counsel at any time. At least five days prior to the scheduled full administrative review, the retailer or applicant must provide the state agency with copies of any written information that it wishes to use during the review and names of witnesses that it will call. Failure to provide the state agency with these items may result in rescheduling the full administrative review or the exclusion of documents and witnesses from the full administrative review.

E. Within 30 days of receipt of the retailer's or applicant's request for a full administrative review, after consulting with the retailer or applicant and the adjudication officer, the state agency shall confirm a date, time, and place for the review. For authorized retailers and applicants, the review shall be scheduled to take place within 60 calendar days after the written request is received by the state agency, unless otherwise agreed to by the parties.

F. Failure to attend the scheduled review shall lead to the retailer forfeiting the rights to any further administrative reviews.

G. The retailer or applicant will have one opportunity to reschedule the full administrative review date or time. All requests to reschedule the review date or time must be submitted in writing at least 24 hours before the scheduled review date unless good cause can be shown as determined by the adjudication officer. Rescheduled reviews shall take place within four weeks of the originally scheduled date unless otherwise agreed to by the parties.

H. If the retailer representative is more than 45 minutes late to the review, this shall be considered a "no show" unless he can show good cause as determined by the adjudication officer.

I. A full administrative review shall be conducted by an adjudication officer who is employed by the Virginia Department of Health. The adjudication officer shall ensure that administrative actions taken by the WIC Program are consistently and fairly applied and that those administrative actions comply with established policies, procedures, and federal and state statutes and regulations. A representative from the state agency shall present its case to the adjudication officer and retailer or applicant representative. Conversely, the retailer owner or designated representative, which may include legal counsel, shall present its case to the adjudication officer.

J. All full administrative reviews shall be held in Richmond, Virginia.

K. After a full administrative review is held, the state WIC director shall provide written notification of the adjudication officer's decision, including the basis for the decision, to the applicant or authorized retailer within 90 calendar days of the date of receipt of the full administrative appeal review request, unless otherwise agreed to by the parties involved. This notification will also be sent to the appropriate USDA Food and Nutrition Services office.

L. Authorized retailers that are being disqualified may continue to submit reimbursement requests until a decision has been rendered by the adjudication officer. The adverse action effective date shall be postponed by the state agency pending the outcome of the review.

M. In accordance with 7 CFR 246.18, if an authorized retailer does not request a full administrative review, then disqualification becomes effective 15 calendar days after the retailer receives the state agency's written disqualification letter.

N. An authorized retailer that is being retained in lieu of disqualification for a state agency violation may elect to voluntarily withdraw from the WIC Program rather than pay a mandated civil monetary penalty. If the retailer voluntarily withdraws and does not pay the civil monetary penalty, then a disqualification status shall be documented in the state agency's records. The disqualification period may range from one to six years, depending on the type of sanctions and violations documented by the state agency.

O. The state agency shall provide a full administrative review to retailers or applicants, upon request, for the following adverse actions pursuant to 7 CFR 246.18:

1. Denial of authorization based on the application of the retailer selection criteria for minimum variety and quantity of authorized supplemental foods or on a determination that the retailer is attempting to circumvent a sanction (7 CFR 246.12);

2. Denial of authorization based upon the retailer selection criteria for business integrity or for a current Supplemental Nutrition Assistance Program disqualification or civil money penalty for hardship (7 CFR 246.12);

3. Denial of authorization based on a state agency established retailer selection criteria if the basis of the denial is a WIC retailer sanction or a Supplemental Nutrition Assistance Program withdrawal of authorization or disqualification;

4. Denial of authorization based on the state agency's retailer limiting criteria (7 CFR 246.12);

5. Denial of authorization because a retailer submitted its application outside the timeframes during which applications are accepted or processed as established by the state agency under 7 CFR 246.12;

6. Termination of a retailer agreement because of a change in ownership, location, or cessation of operations (7 CFR 246.12);

7. Termination of a retailer agreement for cause;

8. Disqualification based on a trafficking conviction (7 CFR 246.12);

9. Disqualification based on the imposition of a Supplemental Nutrition Assistance Program civil monetary penalty for hardship (7 CFR 246.12);

10. Disqualification or civil monetary penalty imposed in lieu of disqualification based on a mandatory sanction imposed by another WIC state agency (7 CFR 246.12);

11. Imposition of a fine or a civil monetary penalty in lieu of disqualification;

12. Denial of authorization based on the application of the retailer selection criteria for competitive price;

13. The application of the state agency's retailer peer group criteria and the criteria used to identify retailers that are above 50% retailers or comparable to above 50% retailers;

14. Denial of an application based on a determination of whether an applicant retailer is currently authorized by the Supplemental Nutrition Assistance Program;

15. A civil monetary penalty imposed in lieu of disqualification based on a Supplemental Nutrition Assistance Program disqualification under 7 CFR 246.12; and

16. Disqualification unless listed in subsection P of this section.

P. The state agency shall notprovide a full administrative review to retailers that appeal the following actions, pursuant to 7 CFR 246.18:

1. The validity or appropriateness of the state agency's retailer limiting or selection criteria or retailer selection criteria for minimum variety and quantity of supplemental foods, business integrity, and current Supplemental Nutrition Assistance Program disqualification or civil monetary penalty for hardship (7 CFR 246.12);

2. The validity or appropriateness of the state agency's criteria for competitive price, including peer group criteria and the criteria used to identify retailers that are above 50% retailers or comparable to above 50% retailers;

3. The validity or appropriateness of the state agency's participant access criteria and the state agency's participant access determinations;

4. The state agency's determination whether a retailer had an effective policy and program in effect to prevent trafficking and that the ownership of the retailer was not aware of, did not approve of, and was not involved in the conduct of the violation (7 CFR 246.12);

5. Denial of authorization if the state agency's retailer authorization is subject to the procurement procedures applicable to the state agency;

6. The expiration of the retailer's agreement;

7. Disputes regarding food instrument payments and retailer claims other than the opportunity to justify or correct a retailer overcharge or other error as permitted by (7 CFR 246.12);

8. Disqualification of a retailer as a result of disqualification from the Supplemental Nutrition Assistance Program (7 CFR 246.12);

9. The state agency's determination to include or exclude an infant formula manufacturer, wholesaler, distributor, or retailer from the list required pursuant to 7 CFR 246.12;

10. The state agency's determination whether to notify a retailer in writing when an investigation reveals an initial violation for which a pattern of violations must be established in order to impose a sanction; and

11. The validity or appropriateness of the state agency's prohibition of incentive items and the state agency's denial of an above 50% retailer's request to provide an incentive item to customers pursuant to 7 CFR 246.12.

Q. A full administrative review request shall not be denied or dismissed unless:

1. The request to the state agency is not postmarked or received within 15 calendar days of the applicant or authorized retailer's receipt of the notice of disqualification or adverse action;

2. The request to the state agency is submitted by an individual who does not have the legal or delegated authority to represent the applicant or authorized retailer;

3. The retailer or authorized representative withdraws the request in writing;

4. The retailer or authorized representative fails to appear at the scheduled review date and time without good cause as determined by the adjudication officer; or

5. The request for a full administrative review is not eligible for this consideration based on the specific exclusion criteria outlined in subsection P of this section.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 19, eff. May 26, 2008; amended, Virginia Register Volume 25, Issue 22, eff. July 6, 2009; Volume 26, Issue 10, eff. January 18, 2010; Volume 29, Issue 12, eff. March 13, 2013; Volume 35, Issue 22, eff. July 24, 2019.

12VAC5-195-680 Food application process

A. WIC eligible food items that are submitted by retailers, manufacturers, and distributors for WIC participants must be reviewed and approved by the state agency. The food application process does not apply to WIC approved formulas.

B. The state agency shall conduct a review of the approved foods every two years. Food applications shall be accepted and processed during a two-month period.

C. The state agency shall notify prospective manufacturers, suppliers, and distributors when food applications will be accepted by sending them an announcement letter. The state agency shall also post the food application announcement letter on the state agency website.

D. The state agency shall maintain a database with the contact names and companies who previously submitted food applications or expressed an interest in having their products considered for WIC approval. Individuals may request to be added to the database on behalf of manufacturers by completing a food application contact form.

E. Incomplete food applications or late submissions shall not be eligible for selection and inclusion on the WIC approved food list.

F. The state agency is responsible for evaluating all completed food applications to ensure each product meets both federal and state nutritional and administrative guidelines.

G. After the food application evaluation and selection process has been completed, a new food list will be printed and distributed to local agencies, WIC participants, and retailers by the state agency. The state agency shall pay all costs associated with producing, printing, and distributing the WIC approved food list. Funds from manufacturers, suppliers, distributors, or other sources shall not be used to reprint the approved food list.

H. If a manufacturer, supplier, or distributor changes the name of an approved product whose trade name appears on the approved food list, the new product shall not be automatically eligible for purchase under the current food list. The manufacturer, supplier, or distributor must submit a written request to the state agency, a sample nutritional label for the new product, and documentation outlining the product availability at authorized retailers to have the new product considered for approval. Once this information is received, the state agency shall decide on a case-by-case basis if the new product can be transitioned under the current food list or must wait for the next food list submission cycle. A new product shall not be approved prior to it being available at retailer locations. If the new product is not eligible for inclusion under the current food list, the manufacturer, supplier, or distributor may submit a new food application using the new product name when food applications are being accepted.

I. If a manufacturer, supplier, or distributor changes the nutritional formulation of an approved product, the new product shall not be eligible for purchase under the current food list. The manufacturer, supplier, or distributor must submit a new food application for the new product when food applications are being accepted.

J. Manufacturers, suppliers, or distributors shall not send product samples to the state agency at any time.

K. Changes to the approved food list made during the scheduled two-year period may be made on a case-by-case basis as determined by the state agency based on federal guidance if applicable.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia; 7 CFR Part 246.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 12, eff. March 13, 2013; Errata, 33:2 VA.R. 298 September 19, 2016; amended, Virginia Register Volume 35, Issue 22, eff. July 24, 2019.

Chapter 200 Regulations Governing Eligibility Standards and Charges for Medical Care Services to Individuals

Part I Definitions

12VAC5-200-10 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Applicant" means the person requesting medical care services for himself or on whose behalf a request is made.

"Board" means the State Board of Health.

"Child" means a person younger than 18 years of age and includes a biological or adopted child and a child placed for adoption or foster care unless otherwise treated as a separate unit for the purposes of determining eligibility and charges under this chapter.

"Commissioner" means the Commissioner of Health.

"Department" means the Virginia Department of Health and includes the central office, regional offices, health districts, and local health departments.

"Eligibility determination" means the process of obtaining required information regarding family size, income, and other related data in order to establish charges to the applicant.

"Extraordinary financial hardship" includes hardship due to natural disasters, damage to or the loss of uninsured real or personal property, unpaid legal liabilities, and obligatory and unavoidable expenditures for close relatives outside the family unit.

"Family" or "family unit" means the applicant and other household members who together constitute one economic unit. An economic unit is one or more individuals who generally reside together and share income. The economic unit shall count in its income any contributions to the unit from persons not necessarily living with the unit.

A parent may be a biological, adoptive, or stepparent.

A woman who is pregnant may be counted as a multiple beneficiary.

Spouses who are separated and are not living together shall be considered to be separate family units.

"Flat rate charges" means charges for specified goods or services that are to be charged to clients regardless of income and with no eligibility determination.

"Gross income" means total cash receipts before taxes from all sources. These include money wages and salaries before any deductions, but do not include food or rent in lieu of wages. These receipts include net receipts from nonfarm or farm self-employment (e.g., receipts from an applicant's own business or farm expenses) income, plus any depreciation shown on income tax forms. They include regular payments from social security or railroad retirement, unemployment and workers' compensation, strike benefits from union funds, veterans' benefits, training stipends, alimony, child support, and military family allotments or other regular support from an absent family member or someone not living in the household; private pensions, government employee pensions (including military retirement pay), and regular insurance or annuity payments; and income from dividends, interest, net rental income, net royalties, or periodic receipts from estates or trusts, lump sum settlements, and net gambling or lottery winnings.

"Gross income" does not include the value of food stamps, Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) checks, fuel assistance payments, housing assistance, money borrowed, tax refunds, gifts, withdrawal of bank deposits from earned income, earnings of minor children, money received from the sale of property, general relief from the Department of Social Services, or college or university scholarships, grants, fellowships, and assistantships when provided to pay for, or in the form of, tuition, fees, other direct educational expenses, housing, or meals.

"Income scales" means scales based on individual or family gross income. They shall be based on the official federal poverty guidelines updated annually by the U.S. Department of Health and Human Services in accordance with § 673(2) of the Omnibus Reconciliation Act of 1981 (Public Law 97-35). There shall be two income scales: one for Northern Virginia and one for the remainder of the Commonwealth.

"Medical care services" means clinical medical, dental, and nursing services provided to patients by physicians, dentists, nurses, and other health care providers employed by health districts or contracted by health districts to provide these services. It does not include laboratory tests, pharmaceutical and biological products, radiological or other imaging studies, other goods or products, or other medical services that a health district does not directly provide.

"Medically indigent" means applicants whose individual or family gross income is defined as Income Level A.

"Minor" means a person younger than 18 years of age whose parents are responsible for the minor's care. A minor will be considered a separate family unit when married or not living with any relative or deemed an adult.

A minor shall be deemed an adult for the purposes of consenting to:

1. Medical or health services needed to determine the presence of or to treat venereal disease or any infectious or contagious disease that the State Board of Health requires to be reported.

2. Medical and health services required for birth control, pregnancy, or family planning except for the purposes of sexual sterilization.

"Nonchargeable services" means the medical care and related goods and services that the department has determined will be provided without charge and without an eligibility determination pursuant to 12VAC5-200-150 to individuals regardless of income.

"Northern Virginia" means the area which includes the cities of Alexandria, Fairfax, Falls Church, Manassas, Manassas Park, and the counties of Arlington, Fairfax, Loudoun, and Prince William.

"Venereal disease" is synonymous with "sexually transmitted infection."

History

• Statutory Authority: §§ 32.1-11 and 32.1-12 of the Code of Virginia.
• Historical Notes: Derived from VR355-39-100 § 1.1, eff. December 1, 1993; amended, Virginia Register Volume 19, Issue 22, eff. August 13, 2003; Volume 20, Issue 22, eff. August 11, 2004; Volume 42, Issue 9, eff. January 29, 2026.

Part II General Information

12VAC5-200-20 (Repealed.)

History

• Historical Notes: Derived from VR355-39-100 § 2.1, eff. December 1, 1993; amended, Virginia Register Volume 20, Issue 22, eff. August 11, 2004; repealed, Virginia Register Volume 42, Issue 9, eff. January 29, 2026.

12VAC5-200-30 (Repealed.)

History

• Historical Notes: Derived from VR355-39-100 § 2.2, eff. December 1, 1993; amended, Virginia Register Volume 20, Issue 22, eff. August 11, 2004; repealed, Virginia Register Volume 42, Issue 9, eff. January 29, 2026.

12VAC5-200-40 (Repealed.)

History

• Historical Notes: Derived from VR355-39-100 § 2.3, eff. December 1, 1993; amended, Virginia Register Volume 20, Issue 22, eff. August 11, 2004; repealed, Virginia Register Volume 42, Issue 9, eff. January 29, 2026.

12VAC5-200-50 Recipients of services

This chapter shall apply to a person seeking medical care services provided by the department, except where other eligibility criteria are required for programs administered under federal statute.

History

• Statutory Authority: §§ 32.1-11 and 32.1-12 of the Code of Virginia.
• Historical Notes: Derived from VR355-39-100 § 2.4, eff. December 1, 1993; amended, Virginia Register Volume 20, Issue 22, eff. August 11, 2004; Volume 42, Issue 9, eff. January 29, 2026.

12VAC5-200-60 (Repealed.)

History

• Historical Notes: Derived from VR355-39-100 § 2.5, eff. December 1, 1993; repealed, Virginia Register Volume 42, Issue 9, eff. January 29, 2026.

12VAC5-200-70 (Repealed.)

Historical Notes

Derived from VR355-39-100 § 2.6, eff. December 1, 1993; repealed, Virginia Register Volume 20, Issue 22, eff. August 11, 2004.

Part III Application and Charges

12VAC5-200-80 Application process and termination of services

A. Upon an applicant's request for medical care services, except the services described in 12VAC5-200-150 and 12VAC5-200-160, the applicant or the applicant's authorized representative shall provide to the department accurate information and documentation regarding the applicant's family size, financial status, and other data needed to register the applicant as a patient and classify the applicant into the appropriate income level.

B. The department shall record the applicant's eligibility date as the date on which the applicant signs the Patient Application and Consent for Health Care.

C. If an applicant needs emergency medical services, the district director or the district director's designee shall waive this application process for that individual until the individual is able to participate in the interviewing process.

D. The district director may terminate medical care services to a patient if the patient fails to make a payment for medical care services or other goods or services received from the department within 90 days after receiving the goods or services. The district director may not terminate services without (i) giving notice to the patient or patient's authorized representative of the intent to terminate, (ii) determining that terminating services would not be detrimental to the patient's health, and (iii) for individuals receiving ongoing care, making a good faith effort to secure alternative care.

History

• Statutory Authority: §§ 32.1-11 and 32.1-12 of the Code of Virginia.
• Historical Notes: Derived from VR355-39-100 § 3.1, eff. December 1, 1993; amended, Virginia Register Volume 20, Issue 22, eff. August 11, 2004; Volume 42, Issue 9, eff. January 29, 2026.

12VAC5-200-90 Charges for services

A. Charges for services means the reasonable charges established by the board for medical care services. No charge shall be established outside the provisions of this chapter. The department may prescribe a scale of discounts for certain medical care services. The commissioner shall publish specific income levels expressed in dollar amounts for determining eligibility for medical care services of the department in accordance with the income scales defined in 12VAC5-200-110.

B. The commissioner shall use the most appropriate current Medicaid charges to establish the fee schedule for services provided by the department pursuant to this chapter. If there is no Medicaid charge for a particular service, the commissioner shall use the most appropriate current Medicare charge. If neither a Medicaid nor a Medicare charge exists for a particular service, the commissioner shall determine an appropriate charge based on the cost of providing the medical care service. Charges for goods and services not directly provided by the agency may be based on the agency's cost. Directors of health districts may request permission from the commissioner or the commissioner's designee to round charges to the nearest whole dollar.

C. If the department provides a medical care service to a patient with private health insurance that covers the service provided, the department shall charge to the private health insurance carrier an amount equal to the allowable charge of the patient's private health insurance coverage. If the health insurance carrier denies a claim for the medical care service, the department may not charge the patient an amount greater than the amount the patient would have paid if the patient did not have private health insurance.

D. On selected occasions it may be desirable to provide certain medical services, such as influenza immunization, to large numbers of people quickly and conveniently and thereby promote their use by the public. In order to accomplish this, districts may charge a flat rate charge for these services under these circumstances. This provision includes services that are otherwise available at a discounted charge. No eligibility determination will be done, and service recipients will be charged the same flat rate charge. However, the district must also provide convenient alternative times and venues where applicants can request an eligibility determination and obtain these services at a discounted rate if eligible. The commissioner or commissioner's designee must approve flat rate charge arrangements in advance, including approval of the specific flat rate charge.

E. Except as otherwise set out in this chapter, charges for certain goods and medical care services may be set at a flat rate charge not subject to discounting. Flat rate charges must be expressly approved by the commissioner or commissioner's designee prior to implementation.

History

• Statutory Authority: §§ 32.1-11 and 32.1-12 of the Code of Virginia.
• Historical Notes: Derived from VR355-39-100 § 3.2, eff. December 1, 1993; amended, Virginia Register Volume 20, Issue 22, eff. August 11, 2004; Volume 42, Issue 9, eff. January 29, 2026.

12VAC5-200-100 (Repealed.)

History

• Historical Notes: Derived from VR355-39-100 § 3.3, eff. December 1, 1993; amended, Virginia Register Volume 20, Issue 22, eff. August 11, 2004; repealed, Virginia Register Volume 42, Issue 9, eff. January 29, 2026.

12VAC5-200-105 Charges for services and goods provided by contract

The department, health districts, and local health departments may enter into contracts with agencies external to the department whereby the department, health district, or local health department provides medical services and goods. Charges for services and goods will be determined by the contract. If a patient copayment is required in the contract, the patient shall pay the full copayment to the department, district, or local health department regardless of the patient's income status. The patient shall not be required to pay if state or federal law precludes a copayment.

History

• Statutory Authority: §§ 32.1-11 and 32.1-12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 20, Issue 22, eff. August 11, 2004; amended, Virginia Register Volume 42, Issue 9, eff. January 29, 2026.

12VAC5-200-110 Income levels for charges

A. The department shall annually publish specific income levels expressed in dollar amounts for determining eligibility for discounts to the charges for medical care services. The income levels established by the department shall be as follows:

1. Income Level A - those clients with individual or family incomes up to and including 100% of the federal poverty income guidelines will qualify as Income Level A clients, except for Northern Virginia, where the Income Level A will be up to and including 110% of the federal poverty income guidelines. These clients will be considered medically indigent.

2. Income Level B - those clients with individual or family incomes above 100% and no more than 110% of the federal poverty guidelines will qualify as Income Level B clients, except for Northern Virginia, where the Income Level B will be above 110% and no more than 133.3% of the federal poverty income guidelines.

3. Income Level C - those clients with individual or family incomes above 110% and no more than 133.3% of the federal poverty income guidelines will qualify as Income Level C clients, except for Northern Virginia, where the Income Level C will be above 133.3% and no more than 166.6% of the federal poverty income guidelines.

4. Income Level D - those clients with individual or family incomes above 133.3% and no more than 166.6% of the federal poverty income guidelines will qualify as Income Level D clients, except for Northern Virginia, where the Income Level D will be above 166.6% and no more than 200% of the federal poverty income guidelines.

5. Income Level E - those clients with individual or family incomes above 166.6% and less than 200% of the federal poverty income guidelines will qualify as Income Level E clients, except for Northern Virginia, where the Income Level E will be above 200% and less than 233.3% of the federal poverty income guidelines.

6. Income Level F - those clients with individual or family incomes equal to or above 200% and less than 250% of the federal poverty income guidelines will qualify as Income Level F clients, except for Northern Virginia, where the Income Level F will be equal to or above 233.3% and less than 283.3% of the federal poverty income guidelines.

7. Income Level G - those clients with individual or family incomes equal to or above 250% of the federal poverty level guidelines will qualify as Income Level G clients, except for Northern Virginia, where income level G will be equal to or above 283.3% of the federal poverty income guidelines.

B. Applicants for medical care services, including those in Northern Virginia as defined in Part I, whose family income exceeds Income Level A shall be assessed a charge as follows:

1. Income Level A – 100% discount of the established charge for the service.

2. Income Level B – 90% discount of the established charge for the service.

3. Income Level C – 75% discount of the established charge for the service.

4. Income Level D – 50% discount of the established charge for the service.

5. Income Level E – 25% discount of the established charge for the service.

6. Income Level F – 5.0% discount of the established charge for the service.

7. Income Level G – No discount will be given.

History

• Statutory Authority: §§ 32.1-11 and 32.1-12 of the Code of Virginia.
• Historical Notes: Derived from VR355-39-100 § 3.4, eff. December 1, 1993; amended, Virginia Register Volume 20, Issue 22, eff. August 11, 2004; Volume 42, Issue 9, eff. January 29, 2026.

12VAC5-200-120 Automatic eligibility

The department shall provide services to an applicant receiving assistance from the following programs as Income Level A patients without additional income verification:

1. General Relief.

2. Title XIX-Medicaid.

3. National School Lunch Program for children receiving school meals at no cost. Only applicable to child dental services.

4. Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Only applicable to dental varnish services under the Dental Varnish Program for children from six months to three years of age.

History

• Statutory Authority: §§ 32.1-11 and 32.1-12 of the Code of Virginia.
• Historical Notes: Derived from VR355-39-100 § 3.5, eff. December 1, 1993; amended, Virginia Register Volume 20, Issue 22, eff. August 11, 2004; Volume 42, Issue 9, eff. January 29, 2026.

12VAC5-200-130 Explanation of charges

The department shall provide an explanation of the estimated charges, applicable discounts, and expected payment to the applicant before rendering services.

History

• Statutory Authority: §§ 32.1-11 and 32.1-12 of the Code of Virginia.
• Historical Notes: Derived from VR355-39-100 § 3.6, eff. December 1, 1993; amended, Virginia Register Volume 20, Issue 22, eff. August 11, 2004; Volume 42, Issue 9, eff. January 29, 2026.

12VAC5-200-140 Redetermination of eligibility

Unless otherwise required by law or regulation, the department shall redetermine eligibility to receive discounts on established charges every 12 months and when income or family status changes.

History

• Statutory Authority: §§ 32.1-11 and 32.1-12 of the Code of Virginia.
• Historical Notes: Derived from VR355-39-100 § 3.7, eff. December 1, 1993; amended, Virginia Register Volume 20, Issue 22, eff. August 11, 2004; Volume 42, Issue 9, eff. January 29, 2026.

Part IV Nonchargeable Services

12VAC5-200-150 Services provided at no charge to the patient

A. The department shall provide the following services at no charge to the patient:

1. Those immunizations for all children as required by §§ 22.1-271.4 and 32.1-46 of the Code of Virginia.

2. Immunizations for a person up to 22 years of age who is enrolled in a public or private primary or secondary school and lacks evidence of complete and appropriate immunizations for the diseases covered by § 32.1-46 of the Code of Virginia.

3. Examination and testing of persons suspected of having or known to have tuberculosis as required by § 32.1-50 of the Code of Virginia.

4. Examination, testing, and treatment of persons for sexually transmitted diseases as required by § 32.1-57 of the Code of Virginia.

5. Anonymous or confidential testing for human immunodeficiency virus as required by § 32.1-55.1 of the Code of Virginia.

B. The department may provide other medical services at no charge to appropriate citizens of the Commonwealth if directed by the board, the commissioner, or a district health director.

History

• Statutory Authority: §§ 32.1-11 and 32.1-12 of the Code of Virginia.
• Historical Notes: Derived from VR355-39-100 § 4.1, eff. December 1, 1993; amended, Virginia Register Volume 20, Issue 22, eff. August 11, 2004; Volume 42, Issue 9, eff. January 29, 2026.

12VAC5-200-160 Immunization services

The department may provide immunization services free of charge to appropriate individuals in the event of an epidemic or when declared necessary by the commissioner or district health director to protect the public health of all citizens of the Commonwealth.

History

• Statutory Authority: §§ 32.1-11 and 32.1-12 of the Code of Virginia.
• Historical Notes: Derived from VR355-39-100 § 4.2, eff. December 1, 1993; amended, Virginia Register Volume 20, Issue 22, eff. August 11, 2004.

12VAC5-200-170 (Repealed.)

History

• Historical Notes: Derived from VR355-39-100 § 4.3, eff. December 1, 1993; amended, Virginia Register Volume 20, Issue 22, eff. August 11, 2004; repealed, Virginia Register Volume 42, Issue 9, eff. January 29, 2026.

Part V Exceptions

12VAC5-200-180 (Repealed.)

History

• Historical Notes: Derived from VR355-39-100 § 5.1, eff. December 1, 1993; amended, Virginia Register Volume 20, Issue 22, eff. August 11, 2004; repealed, Virginia Register Volume 42, Issue 9, eff. January 29, 2026.

12VAC5-200-190 Limitations

A. The district director can limit the provision of medical care services based on an assessment of public need and available department resources.

B. The district director may establish policies to limit the provision of medical care services provided by the department based on legal residence and visa status except where federal funds are appropriated for the service.

History

• Statutory Authority: §§ 32.1-11 and 32.1-12 of the Code of Virginia.
• Historical Notes: Derived from VR355-39-100 § 5.2 and § 5.3, eff. December 1, 1993; amended, Virginia Register Volume 20, Issue 22, eff. August 11, 2004.

12VAC5-200-200 [Reserved]. (Reserved)

12VAC5-200-210 (Repealed.)

Historical Notes

Derived from VR355-39-100 § 5.4, eff. December 1, 1993; repealed, Virginia Register Volume 20, issue 22, eff. August 11, 2004.

Part VI Waiver of Charges

12VAC5-200-220 (Repealed.)

History

• Historical Notes: Derived from VR355-39-100 § 6.1, eff. December 1, 1993; amended, Virginia Register Volume 20, Issue 22, eff. August 11, 2004; repealed, Virginia Register Volume 42, Issue 9, eff. January 29, 2026.

12VAC5-200-230 Waivers

A. The commissioner is authorized, and may delegate the authority to a local health director, to grant or deny a waiver to all or a portion of a charge for reasons of unusually serious health problems or extraordinary financial hardship if a patient or the patient's guardian or legal representative applies for a waiver in writing. A resulting waived or partially waived charge shall be determined by the commissioner or designee and reviewed and revised as needed. The commissioner or designee shall also identify those expenses that are considered to be bills for medical care services and shall review and revise this determination as needed.

B. In the event of an adverse decision, the patient, guardian or other authorized person will be advised of their rights to appeal under Part VII (12VAC5-200-270) of this chapter.

C. An approved waiver shall only be effective for the duration of the health or financial hardship or 180 days, whichever is shorter. The commissioner or the commissioner's designee may grant an additional waiver related to the health or financial hardship if the patient or the patient's guardian or legal representative reapplies for the waiver.

D. No person believed to be eligible for Medicaid or any state-sponsored children's medical insurance program and who has failed to complete an application for these programs will be eligible for a waiver.

History

• Statutory Authority: §§ 32.1-11 and 32.1-12 of the Code of Virginia.
• Historical Notes: Derived from VR355-39-100 § 6.2 through § 6.5, eff. December 1, 1993; amended, Virginia Register Volume 20, Issue 22, eff. August 11, 2004; Volume 42, Issue 9, eff. January 29, 2026.

12VAC5-200-240 [Reserved]. (Reserved)

Part VII Appeal Process

12VAC5-200-270 Rights

A. If an applicant for or recipient of medical care services is denied services, has services terminated, wishes to contest the determined income level, or is denied a waiver as defined in Part VI (12VAC5-200-220 et seq.) of this chapter, the applicant or recipient is entitled to appeal that action as set forth under this part.

B. The district director shall notify the applicant or recipient in writing of the appeal process, including time limits, and the right to receive a written statement of the reasons for denial. If a person already receiving services is denied those services, a written notice of termination shall be given 30 days in advance of discontinuing services. The applicant or recipient has the right to confront any witnesses who may have testified against him.

C. An individual or the individual's representative may make a written or oral appeal to the district or program director within 30 days of the denial of service.

D. Upon receipt of the appeal, the district director shall review and make written recommendations to the commissioner or commissioner's designee within 15 days. Within 45 days following the date on which an appeal is filed, the commissioner or commissioner's designee shall make a final decision and notify the district director of the decision in writing.

E. The district director or the program director shall notify the individual or the individual's representative in writing of the final decision.

F. The department shall continue to provide medical care services to the applicant or recipient during the appeal process.

History

• Statutory Authority: §§ 32.1-11 and 32.1-12 of the Code of Virginia.
• Historical Notes: Derived from VR355-39-100 § 7.1, eff. December 1, 1993; amended, Virginia Register Volume 20, Issue 22, eff. August 11, 2004; Volume 42, Issue 9, eff. January 29, 2026.

Part VIII Fraud

12VAC5-200-280 Fraud

If an applicant for or recipient of medical care services is willfully misrepresenting himself or withholding or falsifying information in an attempt to obtain medical services free or at a reduced rate, the district director may discontinue services to the affected person 30 days after notifying the person that services will be discontinued. The affected person is entitled to the appeal process set forth in Part VII (12VAC5-200-270) of this chapter.

History

• Statutory Authority: §§ 32.1-11 and 32.1-12 of the Code of Virginia.
• Historical Notes: Derived from VR355-39-100 § 8.1, eff. December 1, 1993; amended, Virginia Register Volume 20, Issue 22, eff. August 11, 2004; Volume 42, Issue 9, eff. January 29, 2026.

Part IX Charges and Payment Requirements by Income Levels

12VAC5-200-290 Charges and payment requirements

A. The commissioner shall establish a procedure for the ongoing development, maintenance, revision, and updating of the charges and payments schedules pursuant to this chapter. There shall be two sets of schedules, one for Northern Virginia as defined in 12VAC5-200-10 and one for the remainder of the Commonwealth.

B. The department shall make the charges for medical care services and the income schedules used to determine sliding scale discounts available to the public for inspection and copying at the headquarters, district, and local health department offices of the department.

History

• Statutory Authority: §§ 32.1-11 and 32.1-12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 20, Issue 22, eff. August 11, 2004; amended, Virginia Register Volume 42, Issue 9, eff. January 29, 2026.

Chapter 215 Rules and Regulations Governing Health Data Reporting

Part I Definitions

12VAC5-215-10 Definitions

The following words and terms, when used in this chapter, shall have the following meanings:

"Adjusted patient days" means inpatient days divided by the percentage of inpatient revenues to total patient revenues.

"Board" means the Board of Health.

"Certified nursing facility" means any skilled nursing facility, skilled care facility, intermediate care facility, nursing or nursing care facility, or nursing home, whether freestanding or a portion of a freestanding medical care facility, that is certified as a Medicare or Medicaid provider, or both, pursuant to § 32.1-137 of the Code of Virginia.

"Consumer" means any person (i) whose occupation is other than the administration of health activities or the provision of health services, (ii) who has no fiduciary obligation to a health care institution or other health agency or to any organization, public or private, whose principal activity is an adjunct to the provision of health services, or (iii) who has no material financial interest in the rendering of health services.

"Health care institution" means (i) a general hospital, ordinary hospital, or outpatient surgical hospital, nursing home or certified nursing facility licensed or certified pursuant to Article 1 (§ 32.1-123 et seq.) of Chapter 5 of Title 32.1 of the Code of Virginia, (ii) a mental or psychiatric hospital licensed pursuant to Chapter 8 (§ 37.1-179 et seq.) of Title 37.1 of the Code of Virginia or (iii) a hospital operated by the University of Virginia or Virginia Commonwealth University. In no event shall such term be construed to include continuing care retirement communities which file annual financial reports with the State Corporation Commission pursuant to Chapter 49 (§ 38.2-4900 et seq.) of Title 38.2 of the Code of Virginia, any physician's office, nursing care facility of a religious body which depends upon prayer alone for healing, independent laboratory or outpatient clinic.

"Hospital" means any facility licensed pursuant to § 32.1-123 et seq. or § 37.1-179 et seq. of the Code of Virginia.

"Late charge" means a fee that is assessed a health care institution that submits any of the board's filings past the due date.

"Nursing home" means any facility or any identifiable component of any facility licensed pursuant to Article 1 (§ 32.1-123 et seq.) of Chapter 5 of Title 32.1 of the Code of Virginia, in which the primary function is the provision, on a continuing basis, of nursing services and health-related services for the treatment and inpatient care of two or more nonrelated individuals, including facilities known by varying nomenclature or designation such as convalescent homes, skilled nursing facilities or skilled care facilities, intermediate care facilities, extended care facilities and nursing or nursing care facilities.

"Patient day" means a unit of measure denoting lodging facilities provided and services rendered to one inpatient, between census-taking-hour on two successive days. The day of admission but not the day of discharge or death is counted a patient day. If both admission and discharge or death occur on the same day, the day is considered a day of admission and counts as one patient day. For purposes of filing fees to the board, newborn patient days would be added. For a medical facility, such as an ambulatory surgery center, which does not provide inpatient services, each patient undergoing surgery during any one 24-hour period will be equivalent to one patient day.

History

• Statutory Authority: §§ 32.1-12 and 32.1-276.2 et seq. of the Code of Virginia.
• Historical Notes: Derived from VR370-01-001 § 2.1, eff. February 25, 1987; amended, Virginia Register Volume 5, Issue 12, eff. April 12, 1989; Volume 6, Issue 15, eff. July 1, 1990; Volume 7, Issue 10, eff. April 1, 1990; Volume 8, Issue 1, eff. January 1, 1992; Volume 8, Issue 13, eff. January 1, 1992; Volume 8, Issue 17, eff. July 1, 1992; Volume 8, Issue 21, eff. September 1, 1992; Volume 8, Issue 26, eff. November 1, 1992; Volume 9, Issue 12, eff. April 7, 1993; Volume 10, Issue 15, eff. June 1, 1994; renumbered and amended, Virginia Register Volume 13, Issue 4, eff. December 11, 1996.

Part II General Information

12VAC5-215-20 Authority for regulations

The board, by §§ 32.1-276.2 through 32.1-276.11 of the Code of Virginia, is required to collect, analyze and make public certain financial data and findings relating to hospitals which operate within the Commonwealth of Virginia. Sections 32.1-276.7 and 32.1-276.8 of the Code of Virginia direct the board from time to time to make such rules and regulations as may be necessary to carry out its responsibilities as prescribed in the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-276.2 et seq. of the Code of Virginia.
• Historical Notes: Derived from VR370-01-001 § 2.1, eff. February 25, 1987; amended, Virginia Register Volume 5, Issue 12, eff. April 12, 1989; Volume 6, Issue 15, eff. July 1, 1990; Volume 7, Issue 10, eff. April 1, 1990; Volume 8, Issue 1, eff. January 1, 1992; Volume 8, Issue 13, eff. January 1, 1992; Volume 8, Issue 17, eff. July 1, 1992; Volume 8, Issue 21, eff. September 1, 1992; Volume 8, Issue 26, eff. November 1, 1992; Volume 9, Issue 12, eff. April 7, 1993; Volume 10, Issue 15, eff. June 1, 1994; renumbered and amended, Virginia Register Volume 13, Issue 4, eff. December 11, 1996.

12VAC5-215-30 Purpose, administration, application, and effective date of rules and regulations

A. The board has promulgated these rules and regulations to set forth an orderly administrative process by which the board may govern its own affairs and require compliance with the provisions of §§ 32.1-276.2 through 32.1-276.11 of the Code of Virginia.

B. These rules and regulations are administered by the board.

C. These rules and regulations have general applicability throughout the Commonwealth. The requirements of the Virginia Administrative Process Act, codified as § 9-6.14:1 et seq. of the Code of Virginia, apply to their promulgation.

D. These rules and regulations or any subsequent amendment, modification, or deletion in connection with these rules and regulations shall become effective 30 days after the final regulation is published in The Virginia Register.

History

• Statutory Authority: §§ 32.1-12 and 32.1-276.2 et seq. of the Code of Virginia.
• Historical Notes: Derived from VR370-01-001 § 2.2, eff. February 25, 1987; amended, Virginia Register Volume 5, Issue 12, eff. April 12, 1989; Volume 6, Issue 15, eff. July 1, 1990; Volume 7, Issue 10, eff. April 1, 1990; Volume 8, Issue 1, eff. January 1, 1992; Volume 8, Issue 13, eff. January 1, 1992; Volume 8, Issue 17, eff. July 1, 1992; Volume 8, Issue 21, eff. September 1, 1992; Volume 8, Issue 26, eff. November 1, 1992; Volume 9, Issue 12, eff. April 7, 1993; Volume 10, Issue 15, eff. June 1, 1994; renumbered and amended, Virginia Register Volume 13, Issue 4, eff. December 11, 1996.

12VAC5-215-40 Powers and procedures of regulations not exclusive

The board reserves the right to authorize any procedure for the enforcement of these regulations that is not inconsistent with the provision set forth herein and the provisions of §§ 32.1-27 and 32.1-276.11 of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-276.2 et seq. of the Code of Virginia.
• Historical Notes: Derived from VR370-01-001 § 2.6, eff. February 25, 1987; amended, Virginia Register Volume 5, Issue 12, eff. April 12, 1989; Volume 6, Issue 15, eff. July 1, 1990; Volume 7, Issue 10, eff. April 1, 1990; Volume 8, Issue 1, eff. January 1, 1992; Volume 8, Issue 13, eff. January 1, 1992; Volume 8, Issue 17, eff. July 1, 1992; Volume 8, Issue 21, eff. September 1, 1992; Volume 8, Issue 26, eff. November 1, 1992; Volume 9, Issue 12, eff. April 7, 1993; Volume 10, Issue 15, eff. June 1, 1994; renumbered and amended, Virginia Register Volume 13, Issue 4, eff. December 11, 1996.

Part III Filing Requirements and Fee Structure

12VAC5-215-50 Annual historical filing

Each individual health care institution shall submit an annual historical filing of revenues, expenses, other income, other outlays, assets and liabilities, units of service, and related statistics as prescribed in § 9-158 (Repealed) of the Code of Virginia on forms provided by the board together with unconsolidated certified audited financial statements. If the health care institution is part of a publicly held company, the individual institution may submit unconsolidated unaudited financial statements. Investor-owned institutions organized as proprietorships, partnerships, or S-corporations that impute income tax on the annual historical filing report an imputed income tax based on the maximum tax rates for federal and state income. The combined rate for 1989 is equal to 34% for individuals and 40% for corporations. Operating losses may be carried forward no more than five years but may not be carried back to prior years. The schedule of imputed income taxes shall be reported as a note to the financial statements or as a supplemental schedule of the certified audited financial statements submitted to the board by the institution. The annual historical filing and the unconsolidated certified audited financial statement shall be received by the board no later than 120 days after the end of the respective applicable health care institution's fiscal year. The requirement for the submission of an annual historical filing and an unconsolidated certified audited financial statement may be waived if a health care institution can show that an extenuating circumstance exists. Requests for a waiver must be submitted in writing prior to the due date. Examples of an extenuating circumstance include, but are not limited to, involvement by the institution in a bankruptcy proceeding, closure of the institution, change of ownership of the institution, or the institution is a new facility that has recently opened.

Each health care institution with licensed nursing home beds or certified nursing facility beds shall exclude all revenues, expenses, other income, other outlays, assets and liabilities, units of service and related statistics directly associated with a hospital, continuing care retirement community, or with adult care residence beds in the annual report filed with the board. For those health care institutions that participate in either the Medicare or Medicaid program, the cost allocation methodology required by the Virginia Department of Medical Assistance Services and Medicare for cost reports submitted to it shall be utilized for filings submitted to the board. Any health care institution that does not participate in the Medicare or Medicaid program may develop and utilize an alternative methodology to determine the nursing home portion of its costs if it chooses not to utilize the cost allocation methodology used by the Department of Medical Assistance Services and Medicare. That methodology shall then be approved by the board and the health care institution must continue to utilize that methodology for all subsequent filings unless a subsequent change is approved by the board.

History

• Statutory Authority: §§ 32.1-12 and 32.1-276.2 et seq. of the Code of Virginia.
• Historical Notes: Derived from VR370-01-001 § 4.1, eff. February 25, 1987; amended, Virginia Register Volume 5, Issue 12, eff. April 12, 1989; Volume 6, Issue 15, eff. July 1, 1990; Volume 7, Issue 10, eff. April 1, 1990; Volume 8, Issue 1, eff. January 1, 1992; Volume 8, Issue 13, eff. January 1, 1992; Volume 8, Issue 17, eff. July 1, 1992; Volume 8, Issue 21, eff. September 1, 1992; Volume 8, Issue 26, eff. November 1, 1992; Volume 9, Issue 12, eff. April 7, 1993; Volume 10, Issue 15, eff. June 1, 1994; renumbered and amended, Virginia Register Volume 13, Issue 4, eff. December 11, 1996.

12VAC5-215-60 Schedule of charges

Each health care institution shall file annually a schedule of charges to be in effect on the first day of such fiscal year, as prescribed in § 9-159 A 3 (Repealed) of the Code of Virginia. The institution's schedule of charges shall be received by the board within 10 days after the beginning of its respective applicable fiscal year.

Any subsequent amendment or modification to the annually filed schedule of charges shall be filed within 10 days of the effective date of the revised annual projection. In addition to the requirement above, a new schedule of charges must be submitted if any of the following conditions exist: (i) the creation or revision of a markup or pricing methodology, or (ii) the creation or revision of charges for new services or products. Amendments or modifications to a schedule of charges that are due only to cost adjustments resulting from the pass through of a markup or pricing methodology that had been implemented since the beginning of the fiscal year are considered minimal and need not be reported.

History

• Statutory Authority: §§ 32.1-12 and 32.1-276.2 et seq. of the Code of Virginia.
• Historical Notes: Derived from VR370-01-001 § 4.4, eff. February 25, 1987; amended, Virginia Register Volume 5, Issue 12, eff. April 12, 1989; Volume 6, Issue 15, eff. July 1, 1990; Volume 7, Issue 10, eff. April 1, 1990; Volume 8, Issue 1, eff. January 1, 1992; Volume 8, Issue 13, eff. January 1, 1992; Volume 8, Issue 17, eff. July 1, 1992; Volume 8, Issue 21, eff. September 1, 1992; Volume 8, Issue 26, eff. November 1, 1992; Volume 9, Issue 12, eff. April 7, 1993; Volume 10, Issue 15, eff. June 1, 1994; renumbered and amended, Virginia Register Volume 13, Issue 4, eff. December 11, 1996.

12VAC5-215-70 Survey of rates

Each health care institution shall file annually a survey of rates charged. For hospitals, the survey shall consist of up to 30 select charges, including semi-private and private room rates. The survey shall also consist of charges of the most frequently occurring diagnoses or procedures for inpatient and outpatient treatment. The charges shall be calculated by taking an average for one month of all patient bills where the requested CPT or ICD-9 code numbers are indicated as the principal diagnosis or procedure. For hospitals this information shall be received by the board no later than April 30 of each year.

The annual charge survey for nursing homes shall include up to 30 select charges, including semi-private and private room rates. The select charges shall reflect the rates in effect as of the first day of a sample month to be chosen by the board. For nursing homes this information shall be received by the board no later than March 31 of each year.

History

• Statutory Authority: §§ 32.1-12 and 32.1-276.2 et seq. of the Code of Virginia.
• Historical Notes: Derived from VR370-01-001 § 4.5, eff. February 25, 1987; amended, Virginia Register Volume 5, Issue 12, eff. April 12, 1989; Volume 6, Issue 15, eff. July 1, 1990; Volume 7, Issue 10, eff. April 1, 1990; Volume 8, Issue 1, eff. January 1, 1992; Volume 8, Issue 13, eff. January 1, 1992; Volume 8, Issue 17, eff. July 1, 1992; Volume 8, Issue 21, eff. September 1, 1992; Volume 8, Issue 26, eff. November 1, 1992; Volume 9, Issue 12, eff. April 7, 1993; Volume 10, Issue 15, eff. June 1, 1994; renumbered and amended, Virginia Register Volume 13, Issue 4, eff. December 11, 1996.

12VAC5-215-80 Commercial diversification survey

Each hospital or any corporation that controls a hospital shall respond to a survey conducted by the board to determine the extent of commercial diversification by such hospitals in the Commonwealth. The survey shall be in a form and manner prescribed by the board and shall request the information specified in subdivisions a through j below for each affiliate of such hospital or corporation, if any:

a. The name and principal activity;

b. The date of the affiliation;

c. The nature of the affiliation;

d. The method by which each affiliate was acquired or created;

e. The tax status of each affiliate and, if tax-exempt, its Internal Revenue tax exemption code number;

f. The total assets;

g. The total revenues;

h. The net profit after taxes, or if not-for-profit, its excess revenues;

i. The net equity or, if not-for-profit, its fund balance; and

j. Information regarding related party transactions.

History

• Statutory Authority: §§ 32.1-12 and 32.1-276.2 et seq. of the Code of Virginia.
• Historical Notes: Derived from VR370-01-001 § 4.6, eff. February 25, 1987; amended, Virginia Register Volume 5, Issue 12, eff. April 12, 1989; Volume 6, Issue 15, eff. July 1, 1990; Volume 7, Issue 10, eff. April 1, 1990; Volume 8, Issue 1, eff. January 1, 1992; Volume 8, Issue 13, eff. January 1, 1992; Volume 8, Issue 17, eff. July 1, 1992; Volume 8, Issue 21, eff. September 1, 1992; Volume 8, Issue 26, eff. November 1, 1992; Volume 9, Issue 12, eff. April 7, 1993; Volume 10, Issue 15, eff. June 1, 1994; renumbered and amended, Virginia Register Volume 13, Issue 4, eff. December 11, 1996.

12VAC5-215-90 Affiliates

The information specified in 12VAC5-215-80 shall relate to any legal controls that exist as of the hospital's fiscal year end. The response to the survey shall include the required information for all affiliates in which the hospital or any corporation which controls a hospital has a 25% or greater interest. Information regarding affiliates or organizations that do not have corporate headquarters in Virginia and that do no business in Virginia need not be provided.

History

• Statutory Authority: §§ 32.1-12 and 32.1-276.2 et seq. of the Code of Virginia.
• Historical Notes: Derived from VR370-01-001 § 4.6:1, eff. February 25, 1987; amended, Virginia Register Volume 5, Issue 12, eff. April 12, 1989; Volume 6, Issue 15, eff. July 1, 1990; Volume 7, Issue 10, eff. April 1, 1990; Volume 8, Issue 1, eff. January 1, 1992; Volume 8, Issue 13, eff. January 1, 1992; Volume 8, Issue 17, eff. July 1, 1992; Volume 8, Issue 21, eff. September 1, 1992; Volume 8, Issue 26, eff. November 1, 1992; Volume 9, Issue 12, eff. April 7, 1993; Volume 10, Issue 15, eff. June 1, 1994; renumbered and amended, Virginia Register Volume 13, Issue 4, eff. December 11, 1996.

12VAC5-215-100 Financial statement (healthcare institution)

Each hospital that reports to the board or any corporation which controls a hospital that reports to the board shall submit audited consolidated financial statements and consolidating financial schedules to the board which include its total assets, liabilities, revenues, expenses, and net worth.

History

• Statutory Authority: §§ 32.1-12 and 32.1-276.2 et seq. of the Code of Virginia.
• Historical Notes: Derived from VR370-01-001 § 4.6:5, eff. February 25, 1987; amended, Virginia Register Volume 5, Issue 12, eff. April 12, 1989; Volume 6, Issue 15, eff. July 1, 1990; Volume 7, Issue 10, eff. April 1, 1990; Volume 8, Issue 1, eff. January 1, 1992; Volume 8, Issue 13, eff. January 1, 1992; Volume 8, Issue 17, eff. July 1, 1992; Volume 8, Issue 21, eff. September 1, 1992; Volume 8, Issue 26, eff. November 1, 1992; Volume 9, Issue 12, eff. April 7, 1993; Volume 10, Issue 15, eff. June 1, 1994; renumbered and amended, Virginia Register Volume 13, Issue 4, eff. December 11, 1996.

12VAC5-215-110 Deadline

The information required by 12VAC5-215-80, 12VAC5-215-90, and 12VAC5-215-100 shall be due 120 days after the hospital's fiscal year end.

History

• Statutory Authority: §§ 32.1-12 and 32.1-276.2 et seq. of the Code of Virginia.
• Historical Notes: Derived from VR370-01-001 § 4.6:6, eff. February 25, 1987; amended, Virginia Register Volume 5, Issue 12, eff. April 12, 1989; Volume 6, Issue 15, eff. July 1, 1990; Volume 7, Issue 10, eff. April 1, 1990; Volume 8, Issue 1, eff. January 1, 1992; Volume 8, Issue 13, eff. January 1, 1992; Volume 8, Issue 17, eff. July 1, 1992; Volume 8, Issue 21, eff. September 1, 1992; Volume 8, Issue 26, eff. November 1, 1992; Volume 9, Issue 12, eff. April 7, 1993; Volume 10, Issue 15, eff. June 1, 1994; renumbered and amended, Virginia Register Volume 13, Issue 4, eff. December 11, 1996.

12VAC5-215-120 IRS Forms

Each health care institution that reports to the board, any corporation controlling a hospital, and each affiliate of the hospital or corporation that controls a hospital shall submit, if the health care institution, corporation, or affiliate is an organization exempt from taxes pursuant to § 501(C)(3) of the Internal Revenue Code, a copy of the most recent federal information return (Form 990) which was filed on behalf of the institution, corporation, or affiliate together with all accompanying schedules that are required to be made available to the public by the Internal Revenue Service. Information regarding not-for-profit affiliates which do no business in Virginia need not be submitted.

The information required by this section shall be due to the board 120 days after the completion of the health care institution's fiscal year end. If the information return (Form 990) has not been filed with the Internal Revenue Service, the due date will be extended to no later than the normal due date to the IRS or any extensions granted.

History

• Statutory Authority: §§ 32.1-12 and 32.1-276.2 et seq. of the Code of Virginia.
• Historical Notes: Derived from VR370-01-001 § 4.7, eff. February 25, 1987; amended, Virginia Register Volume 5, Issue 12, eff. April 12, 1989; Volume 6, Issue 15, eff. July 1, 1990; Volume 7, Issue 10, eff. April 1, 1990; Volume 8, Issue 1, eff. January 1, 1992; Volume 8, Issue 13, eff. January 1, 1992; Volume 8, Issue 17, eff. July 1, 1992; Volume 8, Issue 21, eff. September 1, 1992; Volume 8, Issue 26, eff. November 1, 1992; Volume 9, Issue 12, eff. April 7, 1993; Volume 10, Issue 15, eff. June 1, 1994; renumbered and amended, Virginia Register Volume 13, Issue 4, eff. December 11, 1996.

12VAC5-215-130 Filing

All filings required by this chapter will be made to the board.

History

• Statutory Authority: §§ 32.1-12 and 32.1-276.2 et seq. of the Code of Virginia.
• Historical Notes: Derived from VR370-01-001 § 4.8, eff. February 25, 1987; amended, Virginia Register Volume 5, Issue 12, eff. April 12, 1989; Volume 6, Issue 15, eff. July 1, 1990; Volume 7, Issue 10, eff. April 1, 1990; Volume 8, Issue 1, eff. January 1, 1992; Volume 8, Issue 13, eff. January 1, 1992; Volume 8, Issue 17, eff. July 1, 1992; Volume 8, Issue 21, eff. September 1, 1992; Volume 8, Issue 26, eff. November 1, 1992; Volume 9, Issue 12, eff. April 7, 1993; Volume 10, Issue 15, eff. June 1, 1994; renumbered and amended, Virginia Register Volume 13, Issue 4, eff. December 11, 1996.

12VAC5-215-140 Fees

A fee based on an adjusted patient days rate shall be set by the board, based on the needs to meet annual board expenses. The fee shall be established at least annually and reviewed for its sufficiency at least annually by the board. All fees shall be paid directly to the board. The fee shall be no more than 11 cents per adjusted patient day for each health care institution. Prior to the beginning of each new fiscal year, the board shall determine a fee for hospitals and a fee for nursing homes based upon the board's proportionate costs of operation for review of hospital and nursing home filings in the current fiscal year, as well as the anticipated costs for such review in the upcoming year.

History

• Statutory Authority: §§ 32.1-12 and 32.1-276.2 et seq. of the Code of Virginia.
• Historical Notes: Derived from VR370-01-001 § 4.9, eff. February 25, 1987; amended, Virginia Register Volume 5, Issue 12, eff. April 12, 1989; Volume 6, Issue 15, eff. July 1, 1990; Volume 7, Issue 10, eff. April 1, 1990; Volume 8, Issue 1, eff. January 1, 1992; Volume 8, Issue 13, eff. January 1, 1992; Volume 8, Issue 17, eff. July 1, 1992; Volume 8, Issue 21, eff. September 1, 1992; Volume 8, Issue 26, eff. November 1, 1992; Volume 9, Issue 12, eff. April 7, 1993; Volume 10, Issue 15, eff. June 1, 1994; renumbered and amended, Virginia Register Volume 13, Issue 4, eff. December 11, 1996.

12VAC5-215-150 Schedule

Fifty percent of the fee shall be paid to the board no later than 30 days before the beginning of the health care institution's fiscal year. The fee shall be based on the health care institution's most recently submitted annual historical adjusted patient days. If there have been no previous annual historical filings, the health care institution's fee shall be based on its projected adjusted patient days for the fiscal year. The balance of the fee shall be paid to the board at the same time the health care institution submits its annual historical filing under the provisions of 12VAC5-215-50.

History

• Statutory Authority: §§ 32.1-12 and 32.1-276.2 et seq. of the Code of Virginia.
• Historical Notes: Derived from VR370-01-001 § 4.10, eff. February 25, 1987; amended, Virginia Register Volume 5, Issue 12, eff. April 12, 1989; Volume 6, Issue 15, eff. July 1, 1990; Volume 7, Issue 10, eff. April 1, 1990; Volume 8, Issue 1, eff. January 1, 1992; Volume 8, Issue 13, eff. January 1, 1992; Volume 8, Issue 17, eff. July 1, 1992; Volume 8, Issue 21, eff. September 1, 1992; Volume 8, Issue 26, eff. November 1, 1992; Volume 9, Issue 12, eff. April 7, 1993; Volume 10, Issue 15, eff. June 1, 1994; renumbered and amended, Virginia Register Volume 13, Issue 4, eff. December 11, 1996.

12VAC5-215-160 Late fees

A. A late charge shall be paid to the board by a health care institution that files reports or fees past the due date. The late charge may be waived if such a waiver is requested prior to the due date and the health care institution can show that an extenuating circumstance exists. Examples of extenuating circumstances include, but are not limited to, involvement by the institution in a bankruptcy proceeding, closure of the institution, change of ownership of the institution, or the institution is a new facility that has recently opened.

B. A late charge of $10 per working day shall be paid to the board by a health care institution that files its annual historical filing, unconsolidated audited financial statements or fees past the due date.

C. A late charge of $50 shall be paid to the board by the health care institution that files the charge schedule past the due date.

D. A late charge of $25 per working day shall be paid to the board by the reporting entity required to complete the survey required by 12VAC5-215-80 including the audited consolidated financial statement required by 12VAC5-215-100, or both.

E. A late charge of $25 per working day shall be paid to the board by the reporting entity required to complete the survey required by 12VAC5-215-70.

F. A late charge of $25 per working day shall be paid to the board by the reporting entity required to submit the Form 990s as provided by 12VAC5-215-120.

History

• Statutory Authority: §§ 32.1-12 and 32.1-276.2 et seq. of the Code of Virginia.
• Historical Notes: Derived from VR370-01-001 § 4.11, eff. February 25, 1987; amended, Virginia Register Volume 5, Issue 12, eff. April 12, 1989; Volume 6, Issue 15, eff. July 1, 1990; Volume 7, Issue 10, eff. April 1, 1990; Volume 8, Issue 1, eff. January 1, 1992; Volume 8, Issue 13, eff. January 1, 1992; Volume 8, Issue 17, eff. July 1, 1992; Volume 8, Issue 21, eff. September 1, 1992; Volume 8, Issue 26, eff. November 1, 1992; Volume 9, Issue 12, eff. April 7, 1993; Volume 10, Issue 15, eff. June 1, 1994; renumbered and amended, Virginia Register Volume 13, Issue 4, eff. December 11, 1996.

Part IV Work Flow and Analysis

12VAC5-215-170 Analysis of historical filing data and schedule of charges

A. The annual historical filing data submitted by health care institutions as prescribed in 12VAC5-215-50 shall be analyzed as directed by the board.

B. The annual schedule of charges shall be analyzed as directed by the board.

History

• Statutory Authority: §§ 32.1-12 and 32.1-276.2 et seq. of the Code of Virginia.
• Historical Notes: Derived from VR370-01-001 § 5.1, eff. February 25, 1987; amended, Virginia Register Volume 5, Issue 12, eff. April 12, 1989; Volume 6, Issue 15, eff. July 1, 1990; Volume 7, Issue 10, eff. April 1, 1990; Volume 8, Issue 1, eff. January 1, 1992; Volume 8, Issue 13, eff. January 1, 1992; Volume 8, Issue 17, eff. July 1, 1992; Volume 8, Issue 21, eff. September 1, 1992; Volume 8, Issue 26, eff. November 1, 1992; Volume 9, Issue 12, eff. April 7, 1993; Volume 10, Issue 15, eff. June 1, 1994; renumbered and amended, Virginia Register Volume 13, Issue 4, eff. December 11, 1996.

Part V Publication and Dissemination of Information Related to Health Care Institutions

12VAC5-215-180 Rate publication

Periodically, but at least annually, the board will publish the rates charged by each health care institution in Virginia for up to 30 of the most frequently used services in Virginia, including each institution's average semi-private and private room rates. The data will be summarized by geographic area in Virginia, and will be kept on file at the board office for public inspection and made available to the news media. In addition, annual charge schedules and subsequent amendments to these schedules filed under the provisions of 12VAC5-215-60 will be kept on file at the board office for public inspection.

History

• Statutory Authority: §§ 32.1-12 and 32.1-276.2 et seq. of the Code of Virginia.
• Historical Notes: Derived from VR370-01-001 § 6.2, eff. February 25, 1987; amended, Virginia Register Volume 5, Issue 12, eff. April 12, 1989; Volume 6, Issue 15, eff. July 1, 1990; Volume 7, Issue 10, eff. April 1, 1990; Volume 8, Issue 1, eff. January 1, 1992; Volume 8, Issue 13, eff. January 1, 1992; Volume 8, Issue 17, eff. July 1, 1992; Volume 8, Issue 21, eff. September 1, 1992; Volume 8, Issue 26, eff. November 1, 1992; Volume 9, Issue 12, eff. April 7, 1993; Volume 10, Issue 15, eff. June 1, 1994; renumbered and amended, Virginia Register Volume 13, Issue 4, eff. December 11, 1996.

12VAC5-215-190 Annual report publication

Periodically, but at least annually, the board will publish an annual report which will include, but not be limited to the following: cost per admission comparison, cost per patient day comparison, percentage increase in cost per patient day, operating profits and losses, deductions from revenue (contractuals, bad debts, and charity care) and utilization.

History

• Statutory Authority: §§ 32.1-12 and 32.1-276.2 et seq. of the Code of Virginia.
• Historical Notes: Derived from VR370-01-001 § 6.3, eff. February 25, 1987; amended, Virginia Register Volume 5, Issue 12, eff. April 12, 1989; Volume 6, Issue 15, eff. July 1, 1990; Volume 7, Issue 10, eff. April 1, 1990; Volume 8, Issue 1, eff. January 1, 1992; Volume 8, Issue 13, eff. January 1, 1992; Volume 8, Issue 17, eff. July 1, 1992; Volume 8, Issue 21, eff. September 1, 1992; Volume 8, Issue 26, eff. November 1, 1992; Volume 9, Issue 12, eff. April 7, 1993; Volume 10, Issue 15, eff. June 1, 1994; renumbered and amended, Virginia Register Volume 13, Issue 4, eff. December 11, 1996.

12VAC5-215-200 Comparison report

The board will also periodically publish and disseminate information which will allow consumers to compare costs and services of hospitals, nursing homes and certified nursing facilities.

History

• Statutory Authority: §§ 32.1-12 and 32.1-276.2 et seq. of the Code of Virginia.
• Historical Notes: Derived from VR370-01-001 § 6.3:1, eff. February 25, 1987; amended, Virginia Register Volume 5, Issue 12, eff. April 12, 1989; Volume 6, Issue 15, eff. July 1, 1990; Volume 7, Issue 10, eff. April 1, 1990; Volume 8, Issue 1, eff. January 1, 1992; Volume 8, Issue 13, eff. January 1, 1992; Volume 8, Issue 17, eff. July 1, 1992; Volume 8, Issue 21, eff. September 1, 1992; Volume 8, Issue 26, eff. November 1, 1992; Volume 9, Issue 12, eff. April 7, 1993; Volume 10, Issue 15, eff. June 1, 1994; renumbered and amended, Virginia Register Volume 13, Issue 4, eff. December 11, 1996.

12VAC5-215-210 Statistical data

The board shall release historical financial and statistical data reported by health care institutions pursuant to §§ 32.1-276.2 through 32.1-276.11 of the Code of Virginia. Under no circumstances will data be released which contains "personal information" as defined in § 2.1-379(2) of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-276.2 et seq. of the Code of Virginia.
• Historical Notes: Derived from VR370-01-001 § 6.4, eff. February 25, 1987; amended, Virginia Register Volume 5, Issue 12, eff. April 12, 1989; Volume 6, Issue 15, eff. July 1, 1990; Volume 7, Issue 10, eff. April 1, 1990; Volume 8, Issue 1, eff. January 1, 1992; Volume 8, Issue 13, eff. January 1, 1992; Volume 8, Issue 17, eff. July 1, 1992; Volume 8, Issue 21, eff. September 1, 1992; Volume 8, Issue 26, eff. November 1, 1992; Volume 9, Issue 12, eff. April 7, 1993; Volume 10, Issue 15, eff. June 1, 1994; renumbered and amended, Virginia Register Volume 13, Issue 4, eff. December 11, 1996.

Chapter 220 Virginia Medical Care Facilities Certificate of Public Need Rules and Regulations

Part I Definitions

12VAC5-220-10 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Acquisition" means an expenditure of $600,000 or more that changes the ownership of a medical care facility. It shall also include the donation or lease of a medical care facility. An acquisition of a medical care facility shall not include a capital expenditure involving the purchase of stock. See 12VAC5-220-120.

"Amendment" means any modification to an application that is made following the public hearing and prior to the issuance of a certificate and includes those factors that constitute a significant change as defined in this chapter. An amendment shall not include a modification to an application that serves to reduce the scope of a project.

"Applicant" means the owner of an existing medical care facility or the sponsor of a proposed medical care facility project submitting an application for a certificate of public need.

"Application" means a prescribed format for the presentation of data and information deemed necessary by the board to determine a public need for a medical care facility project.

"Application fees" means fees required for a project application and application for a significant change. Fees shall not exceed the lesser of 1.0% of the proposed capital expenditure or cost increase for the project or $20,000.

"Board" means the State Board of Health.

"Capital expenditure" means any expenditure by or in behalf of a medical care facility that, under generally accepted accounting principles, is not properly chargeable as an expense of operation and maintenance. Such expenditure shall also include a series of related expenditures during a 12-month period or a financial obligation or a series of related financial obligations made during a 12-month period by or in behalf of a medical care facility. Capital expenditures need not be made by a medical care facility so long as they are made in behalf of a medical care facility by any person. See definition of "person."

"Certificate of public need" means a document that legally authorizes a medical care facility project as defined herein and which is issued by the commissioner to the owner of such project.

"Clinical health service" means a single diagnostic, therapeutic, rehabilitative, preventive or palliative procedure as defined in § 32.1-102.1 of the Code of Virginia.

"Commissioner" means the State Health Commissioner who has authority to make a determination respecting the issuance or revocation of a certificate.

"Competing applications" means applications for the same or similar services and facilities that are proposed for the same planning district or medical service area and which are in the same review cycle. See 12VAC5-220-220.

"Completion" means conclusion of construction activities necessary for substantial performance of the contract.

"Construction" means the building of a new medical facility or the expansion, remodeling, or alteration of an existing medical care facility.

"Construction, initiation of" means that a project shall be considered under construction for the purpose of certificate extension determinations upon the presentation of evidence by the owner of: (i) a signed construction contract; (ii) the completion of short term financing and a commitment for long term (permanent) financing when applicable; (iii) the completion of predevelopment site work; and (iv) the completion of building foundations.

"Date of issuance" means the date of the commissioner's decision awarding a certificate of public need.

"Department" means the Virginia Department of Health.

"Designated medically underserved areas" means (i) areas designated as medically underserved areas pursuant to § 32.1-122.5 of the Code of Virginia; (ii) federally designated Medically Underserved Areas (MUA); or (iii) federally designated Health Professional Shortage Areas (HPSA).

"Ex parte" means any meeting that takes place between (i) any person acting in behalf of the applicant or holder of a certificate of public need or any person opposed to the issuance or in favor of the revocation of a certificate of public need and (ii) any person who has authority in the department to make a decision respecting the issuance or revocation of a certificate of public need for which the department has not provided 10 days written notification to opposing parties of the time and place of such meeting. An ex parte contact shall not include a meeting between the persons identified in (i) and staff of the department.

"Gamma knife surgery" means stereotactic radiosurgery, where stereotactic radiosurgery is the noninvasive therapeutic procedure performed by directing radiant energy beams from any source at a treatment target in the head to produce tissue destruction. See definition of "project."

"Health planning region" means a contiguous geographical area of the Commonwealth as defined in § 32.1-102.1 of the Code of Virginia.

"Informal fact-finding conference" means a conference held pursuant to § 2.2-4019 of the Code of Virginia.

"Inpatient beds" means accommodations within a medical care facility with continuous support services (such as food, laundry, housekeeping) and staff to provide health or health-related services to patients who generally remain in the medical care facility in excess of 24 hours. Such accommodations are known by varying nomenclatures including but not limited to: nursing beds, intensive care beds, minimal or self care beds, isolation beds, hospice beds, observation beds equipped and staffed for overnight use, and obstetric, medical, surgical, psychiatric, substance abuse, medical rehabilitation and pediatric beds, including pediatric bassinets and incubators. Bassinets and incubators in a maternity department and beds located in labor or birthing rooms, recovery rooms, emergency rooms, preparation or anesthesia inductor rooms, diagnostic or treatment procedures rooms, or on-call staff rooms are excluded from this definition.

"Medical care facility" means any institution, place, building, or agency as defined in § 32.1-102.1 of the Code of Virginia.

"Medical service area" means the geographic territory from which at least 75% of patients come or are expected to come to existing or proposed medical care facilities, the delineation of which is based on such factors as population characteristics, natural geographic boundaries, and transportation and trade patterns, and all parts of which are reasonably accessible to existing or proposed medical care facilities.

"Modernization" means the alteration, repair, remodeling, replacement or renovation of an existing medical care facility or any part thereto, including that which is incident to the initial and subsequent installation of equipment in a medical care facility. See definition of "construction."

"Operating expenditure" means any expenditure by or in behalf of a medical care facility that, under generally accepted accounting principles, is properly chargeable as an expense of operation and maintenance and is not a capital expenditure.

"Operator" means any person having designated responsibility and legal authority from the owner to administer and manage a medical care facility. See definition of "owner."

"Other plans" means any plan(s) which is formally adopted by an official state agency or regional health planning agency and which provides for the orderly planning and development of medical care facilities and services and which is not otherwise defined in this chapter.

"Owner" means any person who has legal responsibility and authority to construct, renovate or equip or otherwise control a medical care facility as defined herein.

"Person" means an individual, corporation, partnership, association or any other legal entity, whether governmental or private. Such person may also include the following:

1. The applicant for a certificate of public need;

2. The regional health planning agency for the health planning region in which the proposed project is to be located;

3. Any resident of the geographic area served or to be served by the applicant;

4. Any person who regularly uses health care facilities within the geographic area served or to be served by the applicant;

5. Any facility or health maintenance organization (HMO) established under § 38.2-4300 et seq. of the Code of Virginia that is located in the health planning region in which the project is proposed and that provides services similar to the services of the medical care facility project under review;

6. Third party payors who provide health care insurance or prepaid coverage to 5.0% or more patients in the health planning region in which the project is proposed to be located; and

7. Any agency that reviews or establishes rates for health care facilities.

"Physician's office" means a place, owned or operated by a licensed physician or group of physicians practicing in any legal form whatsoever, which is designed and equipped solely for the provision of fundamental medical care whether diagnostic, therapeutic, rehabilitative, preventive or palliative to ambulatory patients and which does not participate in cost-based or facility reimbursement from third party health insurance programs or prepaid medical service plans excluding pharmaceuticals and other supplies administered in the office. See definition of "medical care facility."

"Planning district" means a contiguous area within the boundaries established by the Department of Housing and Community Development as set forth in § 15.2-4202 of the Code of Virginia, except that for purposes of this chapter, Planning District 23 shall be divided into two planning districts: Planning District 20, consisting of the counties of Isle of Wight and Southampton and the cities of Chesapeake, Franklin, Norfolk, Portsmouth, Suffolk and Virginia Beach; and Planning District 21, consisting of the counties of James City and York and the cities of Hampton, Newport News, Poquoson and Williamsburg.

"Predevelopment site work" means any preliminary activity directed towards preparation of the site prior to the completion of the building foundations. This includes, but is not limited to, soil testing, clearing, grading, extension of utilities and power lines to the site.

"Primary medical care services" means first-contact, whole-person medical and health services delivered by broadly trained, generalist physicians, nurses and other professionals, intended to include, without limitation, obstetrics/gynecology, family practice, internal medicine and pediatrics.

"Progress" means actions that are required in a given period of time to complete a project for which a certificate of public need has been issued. See 12VAC5-220-450, Demonstration of progress.

"Project" means any plan or proposal as defined in § 32.1-102.1 of the Code of Virginia that is subject to Certificate of Public Need approval.

"Public hearing" means a proceeding conducted by a regional health planning agency at which an applicant for a certificate of public need and members of the public may present oral or written testimony in support or opposition to the application that is the subject of the proceeding and for which a verbatim record is made. See subsection A of 12VAC5-220-230.

"Regional health plan" means the regional plan adopted by the regional health planning agency board.

"Regional health planning agency" means the regional agency as defined in § 32.1-102.1 of the Code of Virginia.

"Rural" means territory, population, and housing units that are classified as "rural" by the Bureau of the Census of the United States Department of Commerce, Economics and Statistics Administration.

"Schedule for completion" means the timetable that identifies the major activities required to complete a project as identified by the applicant and set forth on the certificate of public need. The timetable is used by the commissioner to evaluate the applicant's progress in completing an approved project.

"Significant change" means any alteration, modification or adjustment to a reviewable project for which a certificate of public need has been issued or requested following the public hearing which:

1. Changes the site;

2. Increases the capital expenditure amount authorized by the commissioner on the certificate of public need issued for the project by 10% or more;

3. Changes the service(s) proposed to be offered;

4. Extends the schedule for completion of the project beyond three years (36 months) from the date of certificate issuance or beyond the time period approved by the commissioner at the date of certificate issuance, whichever is greater. See 12VAC5-220-440 and 12VAC5-220-450.

"Standard review process" means the process utilized in the review of all certificate of public need requests with the exception of:

1. Certain bed relocations as specified in 12VAC5-220-280;

2. Certain projects that involve an increase in the number of beds in which nursing facility or extended care services are provided as specified in 12VAC5-220-325.

"State Medical Facilities Plan" means the planning document as contained in Article 1.1 (§ 32.1-102.1 et seq.) of Chapter 4 of Title 32.1 of the Code of Virginia, used to make medical care facilities and services needs decisions.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 1.1, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; Volume 13, Issue 7, eff. January 24, 1997; Volume 14, Issue 12, eff. April 2, 1998; Volume 19, Issue 8, eff. February 3, 2003; Volume 20, Issue 26, eff. September 27, 2004; Volume 24, Issue 11, eff. March 5, 2008.

Part II General Information

12VAC5-220-20 Authority for regulations

The Virginia Medical Care Facilities Certificate of Public Need Law, which is codified as Article 1.1 (§ 32.1-102.1 et seq.) of Chapter 4 of Title 32.1 of the Code of Virginia, requires the owners or sponsors of medical care facility projects to secure a certificate of public need from the State Health Commissioner prior to initiating such projects. Sections 32.1-102.2 and 32.1-12 of the Code of Virginia direct the Board of Health to promulgate and prescribe such rules and regulations as are deemed necessary to effectuate the purposes of this statute.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 2.1, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; Volume 13, Issue 7, eff. January 24, 1997.

12VAC5-220-30 Purpose of chapter

The board has promulgated this chapter to set forth an orderly administrative process for making public need decisions.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 2.2, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994.

12VAC5-220-40 Administration of chapter

This chapter is administered by the following:

1. The Board of Health is the governing body of the Virginia Department of Health. The Board of Health has the authority to promulgate and prescribe such rules and regulations as it deems necessary to effectuate the purposes of the Act.

2. The State Health Commissioner is the executive officer of the Virginia Department of Health. The commissioner is the designated decision maker in the process of determining public need under the Act.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 2.3, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; Volume 13, Issue 7, eff. January 24, 1997.

12VAC5-220-50 Public meetings and public hearings

All meetings and hearings convened to consider any certificate of public need application shall be open to the public in accordance with the provisions of the Virginia Freedom of Information Act (§ 2.1-340 et seq.) of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 2.4, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994.

12VAC5-220-60 Official records

Written information including staff evaluations and reports and correspondence developed or utilized or received by the commissioner during the review of a medical care facility project shall become part of the official project record maintained by the Department of Health and shall be made available to the applicant, competing applicant and review bodies. Other persons may obtain a copy of the project record upon request. All records are subject to the Virginia Freedom of Information Act.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 2.5, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994.

12VAC5-220-70 Application of chapter

This chapter has general applicability throughout the Commonwealth. The requirements of the Virginia Administrative Process Act (§ 9-6.14:1 et seq.) of the Code of Virginia apply to their promulgation.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 2.6, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; Volume 13, Issue 7, eff. January 24, 1997.

12VAC5-220-80 Powers and procedures of chapter not exclusive

The commissioner and the board reserve the right to authorize any procedure for the enforcement of this chapter that is not inconsistent with the provisions set forth herein and the provisions of Article 1.1 (§ 32.1-102.1 et seq.) of Chapter 4 of Title 32.1 of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 2.7, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994.

12VAC5-220-90 Annual report

Pursuant to § 32.1-102.12 of the Code of Virginia, the commissioner shall annually report to the Governor and the General Assembly on the status of Virginia's certificate of public need program.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 2.8, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; Volume 19, Issue 8, eff. February 3, 2003; Volume 26, Issue 2, eff. November 1, 2009.

Part III Mandatory Requirements

12VAC5-220-100 Requirements for reviewable medical care facility projects; exceptions

A. Prior to initiating a reviewable medical care facility project, the owner or sponsor shall obtain a certificate of public need from the commissioner, except as provided in subsection B of this section. In the case of an acquisition of an existing medical care facility, the notification requirement set forth in 12VAC5-220-120 shall be met.

B. Provided that an existing hospital or nursing home complies with subsections C, D, and F of this section, a project involving a temporary increase in the total number of beds in an existing hospital or nursing home shall be exempt from the requirement for a certificate if:

1. The commissioner has determined that a natural disaster or man-made disaster has caused the evacuation of a hospital or nursing home and that a public health emergency exists due to a shortage of hospital or nursing home beds; or

2. The board has entered an emergency order pursuant to § 32.1-13 of the Code of Virginia or if the commissioner has entered an emergency order pursuant to §§ 32.1-13 and 32.1-20 of the Code of Virginia for the purpose of suppressing:

a. A nuisance dangerous to public health;

b. A communicable, contagious, or infectious disease; or

c. Other danger to the public life and health.

C. An existing hospital or nursing home may request a temporary increase in its total number of beds by filing a Request for Temporary Beds form with the department that includes:

1. The name of the hospital or nursing home;

2. The license number of the hospital or nursing home;

3. The name of the nursing home administrator, the hospital chief executive officer, or the chief executive officer's designee;

4. The telephone number of the nursing home administrator, the hospital chief executive officer, or the chief executive officer's designee;

5. The email address of the nursing home administrator, the hospital chief executive officer, or the chief executive officer's designee;

6. The number and type of temporary beds the hospital or nursing home anticipates adding;

7. The planned use of the temporary beds;

8. The plans for staffing the temporary beds;

9. The efforts undertaken or to be undertaken to reduce or eliminate the number of temporary beds needed;

10. The address of the building, temporary structure, or satellite location where the hospital or nursing home intends to locate the temporary beds;

11. The specific locations within the building, temporary structure, or satellite location where the hospital or nursing home intends to locate the temporary beds;

12. Whether the locations identified in subdivision 11 of this subsection meet life safety code requirements for the type of patients or residents expected to occupy those temporary beds;

13. If life safety code requirements are not currently met for the locations identified in subdivision 11 of this subsection, what action the hospital or nursing home will take to meet life safety code requirements; and

14. Any other information that the board or commissioner may request.

D. The hospital or nursing home shall provide additional information as may be requested or required by the commissioner to evaluate the temporary bed request.

E. The commissioner shall notify the hospital or nursing home in writing of the commissioner's decision on the temporary bed request. If granted, the commissioner may attach conditions to the approval that, in the sole judgment of the commissioner, protects public, patient, or resident health, safety, or welfare.

F. The hospital or nursing home may not add temporary beds unless its request has been granted and may not operate temporary beds more than 30 days after the expiration of:

1. The commissioner's determination pursuant to subdivision B 1 of this section; or

2. The board's or the commissioner's emergency order pursuant to subdivision B 2 of this section.

G. The department shall promptly inform the Department of Medical Assistance Services and the Centers for Medicare and Medicaid Services of the identity of any hospital or nursing home certified as a Medicare provider or Medicaid provider that fails to comply with subsection F of this section.

H. The commissioner may rescind or modify the approval of a temporary bed request if:

1. Additional information becomes known that alters the basis for the original approval, including if the hospital or nursing home added temporary beds prior to receiving the approval; or

2. The hospital or nursing home fails to meet any conditions attached to the approval.

I. No certificate of public need shall be required for use of up to 10 beds per day among the medical care facility's inpatient hospital beds as swing beds for the furnishing of services of the type that if furnished by a nursing home or certified nursing facility would constitute skilled care services by a medical care facility described in § 32.1-102.1:3 A 1 of the Code Virginia that is certified as a critical access hospital by the Centers for Medicare and Medicaid Services pursuant to Title XVIII of the Social Security Act (42 USC § 1395 et seq.). For purposes of this subsection, a critical access hospital may calculate the 10-swing-bed-per-day limitation as an average over the fiscal year of the hospital. In the event the calculation exceeds an average of equal to or fewer than 10 swing beds in any fiscal year, the critical access hospital shall have the following fiscal year to reduce the fiscal year average to equal to or fewer than 10 swing beds. Any critical access hospital that fails to reduce the fiscal year average to equal to or fewer than 10 swing beds during the second fiscal year shall no longer be able to calculate the 10-swing-bed limitation by averaging on a fiscal year basis and shall calculate the limitation on a daily basis until such time as it has met the 10-swing-bed-per-day limit for two consecutive fiscal years, at which time averaging may resume. No critical access hospital shall have more than 15 swing beds per day for more than five consecutive days. A critical access hospital shall make a good faith effort and document the efforts made to place each additional patient in a certified nursing facility prior to exceeding the 10-swing-bed-per-day limit.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 3.1, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; Volume 35, Issue 24, eff. August 23, 2019; Volume 42, Issue 5, eff. November 19, 2025; Volume 42, Issue 16, eff. May 7, 2026.

12VAC5-220-105 Requirements for registration of the replacement of existing medical equipment

Within 30 days of any person contracting to make, or otherwise legally obligating to make, a capital expenditure for the replacement of medical equipment or otherwise acquiring replacement medical equipment for the provision of services listed in subdivision 7 of the definition of "project" in 12VAC5-220-10, the person shall register in writing such equipment replacement with the commissioner and the appropriate regional health planning agency. Such registration shall be made on forms provided by the department. The registration shall identify the specific unit of equipment to be replaced and the estimated capital cost of the replacement and shall include documentation that the equipment to be replaced has previously been authorized or exempted as allowed by law.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 14, Issue 12, eff. April 2, 1998; amended, Virginia Register Volume 19, Issue 8, eff. February 3, 2003; Volume 26, Issue 2, eff. November 1, 2009.

12VAC5-220-110 Requirements for registration of certain capital expenditures

A. At least 30 days before any person contracts to make or is otherwise legally obligated to make a capital expenditure by or on behalf of a medical care facility as defined in this chapter that has not been previously authorized by the commissioner, such expenditure shall be registered in writing with the commissioner. The threshold amount for capital expenditure project registration shall be determined using the formula contained in subsection B of this section.

B. The threshold contained in subsection A of this section shall be adjusted annually using the percentage increase listed in the Consumer Price Index for All Urban Consumers (CPI-U) for the most recent year as follows:

A x (1+B)

where:

A = the capital expenditure threshold amount for the previous year

and

B = the percent increase for the expense category "Medical Care" listed in the most recent year available of the CPI-U of the U.S. Bureau of Labor Statistics.

C. The format for registration shall include information concerning the purpose of such expenditure and projected impact that the expenditure will have upon the charges for services. For purposes of registration, the owner shall include any person making the affected capital expenditure. See definition of "project."

D. Annually, the department shall (i) publish the threshold amount in the General Notices section of the Virginia Register of Regulations and (ii) post the threshold amount on its website.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 3.2, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; Volume 13, Issue 7, eff. January 24, 1997; Volume 24, Issue 11, eff. March 5, 2008; Volume 25, Issue 1, eff. October 15, 2008; Volume 26, Issue 2, eff. November 1, 2009; Volume 26, Issue 26, eff. September 30, 2010; Volume 27, Issue 24, eff. September 1, 2011; Volume 30, Issue 8, eff. February 3, 2014.

12VAC5-220-120 Requirement for notification of proposed acquisition of medical care facility

At least 30 days before any person is contractually obligated to acquire an existing medical care facility, the cost of which is $600,000 or more, that person shall provide written notification to the commissioner and the regional health planning agency that serves the area in which the facility is located. Such notification shall identify the name of the medical care facility, the current and proposed owner, the cost of the acquisition, the services to be added or deleted, the number of beds to be added or deleted, and the projected impact that the cost of the acquisition will have upon the charges of the services to be provided in the medical care facility. The commissioner shall provide written notification to the person who plans to acquire the medical care facility within 30 days of receipt of the required notification. If the commissioner finds that a reviewable clinical health service or beds are to be added as a result of the acquisition, the commissioner may require the proposed new owner to obtain a certificate prior to the acquisition. If such certificate is required, an application will be considered under an appropriate batch group which will be identified at the time of written notification by the commissioner to the applicant for such acquisition.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 3.3, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994.

12VAC5-220-130 Significant change limitation

No significant change in a project for which a certificate of public need has been issued shall be made without prior written approval of the commissioner. Such request for a significant change shall be made in writing by the owner to the commissioner with a copy to the appropriate regional health planning agency. The owner shall also submit the application fee to the department if applicable at the time the written request is made. The written request shall identify the nature and purpose of the change. The regional health planning agency shall review the proposed change and notify the commissioner of its recommendation with respect to the change within 30 days from receipt of the request by both the department and the regional health planning agency. Failure of the regional health planning agency to notify the commissioner within the 30-day period shall constitute a recommendation of approval. The commissioner shall act on the significant change request within 35 days of receipt. A public hearing during the review of a proposed significant change request is not required unless determined necessary by the commissioner. The commissioner shall not approve a significant change in cost for a project which exceeds the authorized capital expenditure by more than 20%. The commissioner shall not extend the schedule for completion of a project beyond three years from the date of issuance of the certificate or beyond the time period approved by the commissioner at the date of certificate issuance, whichever is greater, except when delays in completion of a project have been caused by events beyond the control of the owner and the owner has made substantial and continuing progress toward completion of the project.

Exception: The commissioner may approve a significant change in cost for an approved project that exceeds the authorized capital expenditure by more than 20%, provided the applicant has demonstrated that the cost increases are reasonable and necessary under all the circumstances and do not result from any material expansion for the project as approved.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 3.4, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; Volume 24, Issue 11, eff. March 5, 2008.

12VAC5-220-140 Requirements for health maintenance organizations (HMO)

An HMO must obtain a certificate of public need prior to initiating a project. Such HMO must also adhere to the requirements for the acquisition of medical care facilities if appropriate. See definition of "project" and 12VAC5-220-10.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 3.5, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; Volume 13, Issue 7, eff. January 24, 1997.

12VAC5-220-150 (Repealed.)

Historical Notes

Derived from VR355-30-000 § 3.6, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; Volume 13, Issue 7, eff. January 24, 1997; Volume 14, Issue 12, eff. April 2, 1998; repealed, Virginia Register Volume 19, Issue 8, eff. February 3, 2003.

12VAC5-220-155 Requirements for the reporting of charity care

Every medical care facility subject to the requirements of Article 1.1 (§ 32.1-102.1 et seq.) of Chapter 4 of Title 32.1 of the Code of Virginia, other than a nursing home, that is not a medical care facility for which a certificate with conditions imposed pursuant to § 32.1-102.4 F of the Code of Virginia has been issued and that provides charity care, as defined in § 32.1-102.1 of the Code of Virginia, shall annually report to the commissioner the amount of charity care provided.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 35, Issue 24, eff. August 23, 2019.

Part IV Determination of Public Need (Required Considerations)

12VAC5-220-160 Required considerations

In determining whether a public need exists for a proposed project, the applicable requirements of § 32.1-102.2:1 of the Code of Virginia will be considered.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 4.1, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; Volume 19, Issue 8, eff. February 29, 2003; Volume 20, Issue 26, eff. September 27, 2004; Volume 25, Issue 1, eff. October 15, 2008; Volume 26, Issue 2, eff. November 1, 2009.

Part V Standard Review Process

12VAC5-220-170 Preconsultation

Each regional health planning agency and the department shall provide upon request advice and assistance concerning community health resources needs to potential applicants. Such advice and assistance shall be advisory only and shall not be a commitment on behalf of the regional health planning agency or the commissioner.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 5.1, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994.

12VAC5-220-180 Application forms

A. Letter of intent. An applicant shall file a letter of intent with the commissioner to request appropriate application forms, and submit a copy of that letter to the appropriate regional health planning agency, by the later of (i) 30 days prior to the submission of an application for a project included within a particular batch group or (ii) 10 days after the first letter of intent is filed for a project within a particular batch group for the same or similar services and facilities which are proposed for the same planning district or medical service area. The letter shall identify the owner, the type of project for which an application is requested, and the proposed scope (size) and location of the proposed project. The department shall transmit application forms to the applicant within seven days of the receipt of the letter of intent. A letter of intent filed with the department shall be considered void one year after the date of receipt of such letter. (See 12VAC5-220-310 C.)

B. Application fees. The department shall collect application fees for applications that request a certificate of public need. The fee required for an application shall be 1.0% of the proposed expenditure for the project, but not less than $1,000 and no more than $20,000.

No application will be deemed to be complete for review until the required application fee is paid. (See 12VAC5-220-310 C.)

C. Filing application forms. Applications must be submitted at least 40 days prior to the first day of a scheduled review cycle to be considered for review in the same cycle. In order to verify the date of the department's and the appropriate regional health planning agency's receipt of the application, the applicant shall transmit the document electronically, or prepare in triplicate two copies to be submitted to the department and one copy to be submitted to the appropriate regional health planning agency and sent by certified mail or a delivery service, return receipt requested, or by hand, with a signed receipt to be provided. No application shall be deemed to have been submitted until required copies have been received by the department and the appropriate regional health planning agency. (See 12VAC5-220-200.)

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 5.2, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; Volume 14, Issue 12, eff. April 2, 1998; Volume 19, Issue 8, eff. February 3, 2003; Volume 26, Issue 2, eff. November 1, 2009.

12VAC5-220-190 Review for completeness

The applicant shall be notified by the department within 15 days following receipt of the application if additional information is required to complete the application or the application is complete as submitted. No application shall be reviewed until the department has determined that it is complete. To be complete, all questions must be answered to the satisfaction of the commissioner and all requested documents supplied, when applicable and the application fee submitted. Additional information required to complete an application shall be submitted to the department and the appropriate regional health planning agency at least five days prior to the first day of a review cycle to be considered complete for review in the same review cycle. (See 12VAC5-220-200.)

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 5.3, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994.

12VAC5-220-200 One hundred ninety-day review cycle

A. The department shall review the following groups of completed applications in accordance with the following 190-day scheduled review cycles and the following descriptions of projects within each group, except as provided for in 12VAC5-220-220.

| BATCH GROUP | GENERAL DESCRIPTION | REVIEW CYCLE | | | --- | --- | --- | --- | | Begins | Ends | | | | A | General Hospitals/Obstetrical Services/Neonatal Special Care Services | Feb. 10 Aug. 10 | Aug. 18 Feb. 16 | | B | Open Heart Surgery/Cardiac Catheterization/Ambulatory Surgery Centers/Operating Room Additions/Transplant Services | Mar. 10 Sep. 10 | Sep. 16 Mar. 19 | | C | Psychiatric Facilities/Substance Abuse Treatment/Mental Retardation Facilities | Apr. 10 Oct. 10 | Oct. 17 Apr. 18 | | D/F | Diagnostic Imaging Facilities/Services Selected Therapeutic Facilities/Services | May 10 Nov. 10 | Nov. 16 May 19 | | E | Medical Rehabilitation Beds/Services | June 10 Dec. 10 | Dec. 17 Jun. 18 | | D/F | Selected Therapeutic Facilities/Services Diagnostic Imaging Facilities/Services | July 10 Jan. 10 | Jan. 16 Jul. 18 | | G | Nursing Home Beds at Retirement Communities/Bed Relocations/Miscellaneous Expenditures by Nursing Homes | Jan. 10 Mar. 10 May 10 July 10 Sep. 10 Nov. 10 | Jul. 18 Sep. 16 Nov. 16 Jan. 16 Mar. 19 May 19 |

Batch Group A includes:

1. The establishment of a general hospital.

2. An increase in the total number of general acute care beds in an existing or authorized general hospital.

3. The relocation at the same site of 10 general hospital beds or 10% of the general hospital beds of a medical care facility, whichever is less, from one existing physical facility to another in any two-year period if such relocation involves a capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B of this section (see 12VAC5-220-280).

4. The introduction into an existing medical care facility of any new neonatal special care or obstetrical services that the facility has not provided in the previous 12 months.

5. Any capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B of this section and not defined as a project category included in Batch Groups B through G, by or in behalf of a general hospital.

Batch Group B includes:

1. The establishment of a specialized center, clinic, or portion of a physician's office developed for the provision of outpatient or ambulatory surgery or cardiac catheterization services.

2. An increase in the total number of operating rooms in an existing medical care facility or establishment of operating rooms in a new facility.

3. The introduction into an existing medical care facility of any new cardiac catheterization, open heart surgery, or organ or tissue transplant services that the facility has not provided in the previous 12 months.

4. The addition by an existing medical care facility of any medical equipment for the provision of cardiac catheterization.

5. Any capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B of this section and not defined as a project category in Batch Group A or Batch Groups C through G, by or in behalf of a specialized center, clinic, or portion of a physician's office developed for the provision of outpatient or ambulatory surgery or cardiac catheterization services.

6. Any capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B of this section and not defined as a project category in Batch Group A or Batch Groups C through G, by or in behalf of a medical care facility, that is primarily related to the provision of surgery, cardiac catheterization, open heart surgery, or organ or tissue transplant services.

Batch Group C includes:

1. The establishment of a mental hospital, psychiatric hospital, intermediate care facility established primarily for the medical, psychiatric or psychological treatment and rehabilitation of alcoholics or drug addicts, or mental retardation facility.

2. An increase in the total number of beds in an existing or authorized mental hospital, psychiatric hospital, intermediate care facility established primarily for the medical, psychiatric or psychological treatment and rehabilitation of alcoholics or drug addicts, or mental retardation facility.

3. An increase in the total number of mental hospital, psychiatric hospital, substance abuse treatment and rehabilitation, or mental retardation beds in an existing or authorized medical care facility that is not a dedicated mental hospital, psychiatric hospital, intermediate care facility established primarily for the medical, psychiatric or psychological treatment and rehabilitation of alcoholics or drug addicts, or mental retardation facility.

4. The relocation at the same site of 10 mental hospital, psychiatric hospital, substance abuse treatment and rehabilitation, or mental retardation beds or 10% of the mental hospital, psychiatric hospital, substance abuse treatment and rehabilitation, or mental retardation beds of a medical care facility, whichever is less, from one existing physical facility to another in any two-year period if such relocation involves a capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B of this section (see 12VAC5-220-280).

5. The introduction into an existing medical care facility of any new psychiatric or substance abuse treatment service that the facility has not provided in the previous 12 months.

6. Any capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B of this section and not defined as a project category in Batch Groups A and B or Batch Groups D/F through G, by or in behalf of a mental hospital, psychiatric hospital, intermediate care facility established primarily for the medical, psychiatric or psychological treatment and rehabilitation of alcoholics or drug addicts, or mental retardation facilities.

7. Any capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B of this section and not defined as a project category in Batch Groups A and B or Batch Groups D/F through G, by or in behalf of a medical care facility, which is primarily related to the provision of mental health, psychiatric, substance abuse treatment or rehabilitation, or mental retardation services.

Batch Group D/F includes:

1. The establishment of a specialized center, clinic, or that portion of a physician's office developed for the provision of computed tomographic (CT) scanning, magnetic resonance imaging (MRI), magnetic source imaging (MSI), positron emission tomographic (PET) scanning, or nuclear medicine imaging, except for the purpose of nuclear cardiac imaging.

2. The introduction into an existing medical care facility of any new computed tomography (CT), magnetic resonance imaging (MRI), magnetic source imaging (MSI), positron emission tomographic (PET) scanning, or nuclear medicine imaging services, except for the purpose of nuclear cardiac imaging that the facility has not provided in the previous 12 months.

3. The addition by an existing medical care facility of any equipment for the provision of computed tomography (CT), magnetic resonance imaging (MRI), magnetic source imaging (MSI), or positron emission tomographic (PET) scanning.

4. Any capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B of this section and not defined as a project category in Batch Groups A, B, C, E, and G, by or in behalf of a specialized center, clinic, or that portion of a physician's office developed for the provision of computed tomographic (CT) scanning, magnetic resonance imaging (MRI), magnetic source imaging (MSI), positron emission tomographic (PET) scanning, or nuclear medicine imaging, except that portion of a physician's office dedicated to providing nuclear cardiac imaging.

5. Any capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B of this section and not defined as a project category in Batch Groups A, B, C, E, and G, by or in behalf of a medical care facility, which is primarily related to the provision of computed tomographic (CT) scanning, magnetic resonance imaging (MRI), magnetic source imaging (MSI), positron emission tomographic (PET) scanning, or nuclear medicine imaging, except for the purpose of nuclear cardiac imaging.

Batch Group E includes:

1. The establishment of a medical rehabilitation hospital.

2. An increase in the total number of beds in an existing or authorized medical rehabilitation hospital.

3. An increase in the total number of medical rehabilitation beds in an existing or authorized medical care facility that is not a dedicated medical rehabilitation hospital.

4. The relocation at the same site of 10 medical rehabilitation beds or 10% of the medical rehabilitation beds of a medical care facility, whichever is less, from one existing physical facility to another in any two-year period, if such relocation involves a capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B of this section (see 12VAC5-220-280).

5. The introduction into an existing medical care facility of any new medical rehabilitation service that the facility has not provided in the previous 12 months.

6. Any capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B of this section and not defined as a project category in Batch Groups A, B, C, D/F, and G, by or in behalf of a medical rehabilitation hospital.

7. Any capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B of this section and not defined as a project category in Batch Groups A, B, C, D/F, and G, by or in behalf of a medical care facility, that is primarily related to the provision of medical rehabilitation services.

Batch Group D/F includes:

1. The establishment of a specialized center, clinic, or that portion of a physician's office developed for the provision of gamma knife surgery, lithotripsy, or radiation therapy.

2. Introduction into an existing medical care facility of any new gamma knife surgery, lithotripsy, or radiation therapy services that the facility has not provided in the previous 12 months.

3. The addition by an existing medical care facility of any medical equipment for the provision of gamma knife surgery, lithotripsy, or radiation therapy.

4. Any capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B of this section and not defined as a project in Batch Groups A, B, C, E, and G, by or in behalf of a specialized center, clinic, or that portion of a physician's office developed for the provision of gamma knife surgery, lithotripsy, or radiation therapy.

5. Any capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B of this section and not defined as a project in Batch Groups A, B, C, E, and G, by or in behalf of a medical care facility, which is primarily related to the provision of gamma knife surgery, lithotripsy, or radiation therapy.

Batch Group G includes:

1. The establishment of a nursing home, intermediate care facility, or extended care facility of a continuing care retirement community by a continuing care provider registered with the State Corporation Commission pursuant to Chapter 49 (§ 38.2-4900 et seq.) of Title 38.2 of the Code of Virginia.

2. The establishment of a nursing home, intermediate care facility, or extended care facility that does not involve an increase in the number of nursing home facility beds within a planning district.

3. An increase in the total number of beds in an existing or authorized nursing home, intermediate care facility, or extended care facility of a continuing care retirement community by a continuing care provider registered with the State Corporation Commission pursuant to Chapter 49 (§ 38.2-4900 et seq.) of Title 38.2 of the Code of Virginia.

4. An increase in the total number of beds in an existing or authorized nursing home, intermediate care facility, or extended care facility that does not involve an increase in the number of nursing home facility beds within a planning district.

5. The relocation at the same site of 10 nursing home, intermediate care facility, or extended care facility beds or 10% of the nursing home, intermediate care facility, or extended care facility beds of a medical care facility, whichever is less, from one physical facility to another in any two-year period, if such relocation involves a capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B of this section (see 12VAC5-220-280).

6. Any capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B of this section and not defined as a project category in Batch Groups A through D/F, by or in behalf of a nursing home, intermediate care facility, or extended care facility, which does not increase the total number of beds of the facility.

7. Any capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B of this section and not defined as a project category in Batch Groups A through D/F, by or in behalf of a medical care facility, that is primarily related to the provision of nursing home, intermediate care, or extended care services, and does not increase the number of beds of the facility.

B. The capital expenditure threshold referenced in subsection A of this section shall be adjusted annually using the percentage increase listed in the Consumer Price Index for All Urban Consumers (CPI-U) for the most recent year as follows:

A x (1+B)

where:

A = the capital expenditure threshold amount for the previous year

and

B = the percent increase for the expense category "Medical Care" listed in the most recent year available of the CPI-U of the U.S. Bureau of Labor Statistics.

C. Annually, the department shall (i) publish the threshold amount in the General Notices section of the Virginia Register of Regulations and (ii) post the threshold amount on its website.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 5.4, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; Volume 13, Issue 7, eff. January 24, 1997; Volume 14, Issue 12, eff. April 2, 1998; Volume 19, Issue 8, eff. February 3, 2003; Volume 20, Issue 2, eff. November 5, 2003; Volume 24, Issue 11, eff. March 5, 2008; Volume 25, Issue 1, eff. October 15, 2008; Volume 26, Issue 2, eff. November 1, 2009; Volume 26, Issue 26, eff. September 30, 2010; Volume 27, Issue 24, eff. September 1, 2011; Volume 30, Issue 8, eff. February 3, 2014.

12VAC5-220-210 Requests for application (RFA)

The commissioner may request the submission of applications for his consideration which address a specific need for services and facilities as identified in the State Medical Facilities Plan. The department shall give notice of such RFA in a newspaper of general circulation in the locality or the planning district where the specific services or facility is requested. Such notice shall be published at least 120 days prior to the first day of the appropriate review cycle for the type of project being requested. A written copy of an RFA shall also be available upon request from the department and the regional health planning agency in the appropriate geographic area. The process for adoption of an RFA by the commissioner for projects listed in § 32.1-102.3:2 A, B, and C of the Code of Virginia are set forth in 12VAC5-220-335.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 5.5, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; Volume 13, Issue 7, eff. January 24, 1997; Volume 26, Issue 2, eff. November 1, 2009.

12VAC5-220-220 Consideration of applications

Applications for the same or similar services which are proposed for the same planning district or medical service area shall be considered as competing applications by the commissioner. The commissioner shall determine whether an application is competing and shall provide written notification to the competing applicants and the regional health planning agency. The commissioner may, upon the request of an applicant, waive the review schedule requirements of 12VAC5-220-200 in the case of a documented emergency or in cases where, as of the deadline for filing a letter of intent for the otherwise applicable cycle, there are no competing applicants, and the applicant who has filed a letter of intent for a particular project proposes to combine the intended project with another related project for which an application will be filed in a subsequent batch group.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 5.6, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994.

12VAC5-220-230 Review of complete application

A. Review cycle. At the close of the work day on the tenth day of the month, the department shall provide written notification to applicants specifying the acceptance date and review schedule of completed applications, including the date for any informal fact-finding conference that may be held between the eightieth and ninetieth day of the review cycle. The regional health planning agency shall conduct no more than two meetings, one of which must be a public hearing conducted by the regional health planning agency board or a subcommittee of the board and provide applicants with an opportunity, prior to the vote, to respond to any comments made about the project by the regional health planning agency staff, any information in a staff report, the comments of local governing bodies in the health planning district, all other public comments, or comments by those voting in completing its review and recommendation by the sixtieth day of the cycle. By the seventieth day of the review cycle, the department shall complete its review and recommendation of an application and transmit the same to the applicants and other appropriate persons. By the seventy-fifth day of the review cycle, the department shall transmit to the applicant and the appropriate other persons its determination whether an informal fact-finding conference is necessary.

An informal fact-finding conference shall be held when (i) determined necessary by the department or (ii) requested by any person seeking to be made a party to the case for good cause. Any person seeking to be made a party to the case for good cause shall file, no later than four days after the department has completed its review and recommendation of an application and has transmitted the same to the applicants and to persons who have prior to the issuance of the report requested a copy in writing, written notification with the commissioner, applicants and other competing applicants, and regional health planning agency stating the grounds for good cause and providing the factual basis therefor under oath.

For purposes of this section, "good cause" means that (i) there is significant, relevant information not previously presented at and not available at the time of the public hearing, (ii) there have been significant changes in factors or circumstances relating to the application subsequent to the public hearing, or (iii) there is a substantial material mistake of fact or law in the department staff's report on the application or in the report submitted by the regional health planning agency. See § 32.1-102.6 of the Code of Virginia.

B. Time period for review. The review period shall begin on the first day of the applicable review cycle within which an application is determined to be complete, in accordance with scheduled batch review cycles described in 12VAC5-220-200. If the application is not determined to be complete for the applicable batch cycle within 40 calendar days from the date of submission, the application may be refiled in the next applicable batch cycle.

If the regional health planning agency has not completed its review by the sixtieth day of the review cycle, or such other period in accordance with the applicant's request for extension, and submitted its recommendation within 10 calendar days after the completion of its review, the department shall, on the eleventh day after expiration of the regional health planning agency's review period, proceed as if the regional health planning agency has recommended approval of the proposed project.

In any case in which an informal fact-finding conference is not held, the project record shall be closed on the earlier of (i) the date established for holding the informal fact-finding conference or (ii) the date that the department determines that an informal fact-finding conference is not necessary. See 12VAC5 220-230 A.

In any case in which an informal fact-finding conference is held, a date shall be established for closing of the record that shall not be more than 30 calendar days after the date for holding the informal fact-finding conference.

C. Determination by the commissioner. If a determination whether a public need exists for a project is not made by the commissioner within 45 calendar days of the closing of the record, the commissioner shall notify the applicant or applicants and any persons seeking to show good cause, in writing, that the application or the applications of each shall be deemed approved 25 calendar days after the expiration of such 45-calendar-day period, unless the receipt of recommendations from the person performing as hearing officer permits the commissioner to issue his case decision within that 25-calendar-day period. The validity or timeliness of the aforementioned notice shall not, in any event, prevent, delay or otherwise impact the effectiveness of this section.

In any case when a determination whether a public need exists for a project is not made by the commissioner within 70 calendar days after closing of the record, the application shall be deemed approved and a certificate shall be granted.

If a determination whether a public need for a project exists is not made by the commissioner within 45 calendar days of the closing of the record, any person who has filed an application competing in the relevant batch review cycle or who has filed an application in response to the relevant Request for Applications issued pursuant to 12VAC5-220-355 may, prior to the application being deemed approved, petition for immediate injunctive relief pursuant to § 2.2-4030 of the Code of Virginia, naming as respondents the commissioner and all parties to the case. During the pendency of proceeding, no applications shall be deemed to be approved. In such a proceeding, the provisions of § 2.2-4030 of the Code of Virginia shall apply.

Deemed approvals shall be construed as the commissioner's case decision on the application pursuant to the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) and shall be subject to judicial review on appeal as the commissioner's case decision in accordance with such act.

Any person who has sought to participate in the department's review of such deemed-to-be-approved application as a person showing good cause who has not received a final determination from the commissioner concerning such attempt to show good cause shall be deemed to be a person showing good cause for purposes of appeal of a deemed-to-be-approved certificate.

In any appeal of the commissioner's case decision granting a certificate of public need pursuant to a Request for Applications issued pursuant to § 32.1-102.3:2 of the Code of Virginia, the court may require the appellant to file a bond pursuant to § 8.01-676.1 of the Code of Virginia, in such sum as shall be fixed by the court for protection of all parties interested in the case decision, conditioned on the payment of all damages and costs incurred in consequence of such appeal.

The applicants, and only the applicants, shall have the authority to extend any of the time periods for review of the application, which are specified in 12VAC5-220-230. If all applicants consent to extending any time period in this section, the commissioner, with the concurrence of the applicants, shall establish a new schedule for the remaining time periods.

For purposes of project review, any scheduled deadlines that fall on a weekend or state holiday shall be advanced to the next work day.

D. Regional health planning agency required notifications. Upon notification of the acceptance date of a complete application as set forth in subsection A of this section, the regional health planning agency shall provide written notification of its review schedule to the applicant. The regional health planning agency shall notify the local governing bodies in the planning district, health care providers and specifically identifiable consumer groups who may be affected by the proposed project directly by mail and shall also give notice of the public hearing in a newspaper of general circulation in such county or city wherein a project is proposed or a contiguous county or city at least nine days prior to such public hearing. Such notification by the regional health planning agency shall include: (i) the date and location of the public hearing which shall be conducted on the application except as otherwise provided in this chapter, in the county or city wherein a project is proposed or a contiguous county or city and (ii) the date, time and place the final recommendation of the regional health planning agency shall be made. The regional health planning agency shall maintain a verbatim record of the public hearing that includes any comments of the local governing bodies of the health planning district and all other public comments. A copy of the verbatim record shall be provided to the department. Such public hearing record shall be maintained for at least a one-year time period following the final decision on a certificate of public need application. See definition of "public hearing."

E. Ex parte contact. After commencement of a public hearing and before a final decision is made, there shall be no ex parte contacts between the State Health Commissioner and any person acting on behalf of the applicant or holder of a certificate or any person opposed to the issuance or in favor of revocation of a certificate of public need, unless written notification has been provided. See definition of "ex parte."

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 5.7, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; Volume 13, Issue 7, eff. January 24, 1997; Volume 14, Issue 12, eff. April 2, 1998; Volume 19, Issue 8, eff. February 3, 2003; Volume 20, Issue 26, eff. September 27, 2004.

12VAC5-220-240 Participation by other persons

Any person affected by a proposed project under review may directly submit written opinions, data and other information to the appropriate regional health planning agency and the commissioner for consideration prior to their final action.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 5.8, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994.

12VAC5-220-250 Amendment to an application

The applicant shall have the right to amend an application at any time. Any amendment which is made to an application following the public hearing and prior to the issuance of a certificate unless otherwise specified in this chapter shall constitute a new application and shall be subject to the review requirements set forth in Part V of this chapter. If such amendment is made subsequent to the issuance of a certificate of public need, it shall be reviewed in accordance with 12VAC5-220-130.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 5.9, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; Volume 13, Issue 7, eff. January 24, 1997.

12VAC5-220-260 Withdrawal of an application

The applicant shall have the right to withdraw an application from consideration at any time, without prejudice by written notification to the commissioner.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 5.10, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994.

12VAC5-220-270 Action on an application

A. Commissioner's responsibility. Decisions as to approval or disapproval of applications or a portion thereof for certificates of public need shall be rendered by the commissioner. Any decision to issue or approve the issuance of a certificate shall be consistent with the most recent applicable provisions of the State Medical Facilities Plan. However, if the commissioner finds, upon presentation of appropriate evidence, that the provisions of either such plan are not relevant to a rural locality's needs, inaccurate, outdated, inadequate, or otherwise inapplicable, the commissioner, consistent with such finding, may issue or approve the issuance of a certificate and shall initiate procedures to make appropriate amendments to such plan.

B. Conditions of approval.

1. The commissioner may condition the approval of an application for a project (i) on the agreement by the applicant to provide an acceptable level of care at a reduced rate to indigents, (ii) on the agreement of the applicant to provide care to persons with special needs, or (iii) upon the agreement of the applicant to facilitate the development and operation of primary medical care services in designated medically underserved areas of the applicant's service area. The terms of such agreements shall be specified in writing prior to the commissioner's decision to approve a project. Any person willfully refusing, failing, or neglecting to honor such agreement shall be subject to a civil penalty of $100 per violation per day from the date of receipt from the department of written notice of noncompliance until the date of compliance. Upon information and belief that a person has failed to honor such agreement in accordance with this provision, the department shall notify the person in writing, and 15 days shall be provided for response in writing including a plan for immediate correction. In the absence of an adequate response or necessary compliance or both, a judicial action shall be initiated in accordance with the provisions of § 32.1-27 of the Code of Virginia.

2. Pursuant to the regulations of the board, the commissioner may condition the approval of a certificate for any project to (i) establish a medical care facility pursuant to § 32.1-102.1:3 A 2 of the Code of Virginia; (ii) introduce a psychiatric service pursuant to § 32.1-102.1:3 B 5 of the Code of Virginia; or (iii) add psychiatric beds to an existing medical care facility described in § 32.1-102.1:3 A 1 or A 2 of the Code of Virginia upon the agreement of the applicant to provide care to individuals who are the subject of an involuntary temporary detention pursuant to § 37.2-809 of the Code of Virginia.

C. Notification process - extension of review time. The commissioner shall make a final determination on an application for a certificate of public need and provide written notification detailing the reasons for such determination to the applicant with a copy to the regional health planning agency within the timeframes specified in 12VAC5-220-230 B unless authorization is given by the applicant to extend the time period. Such written notification shall also reference the factors and bases considered in making a decision on the application and, if applicable, the remedies available for appeal of such decision and the progress reporting requirements. The commissioner may approve a portion of a project provided the portion to be approved is agreed to by the applicant following consultation, which may be subject to the ex parte provision of this chapter, between the commissioner and the applicant.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 5.11, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; Volume 13, Issue 7, eff. January 24, 1997; Volume 19, Issue 8, eff. February 3, 2003; Volume 42, Issue 5, eff. November 19, 2025.

Part VI Expedited Review Process

12VAC5-220-280 Applicability

Capital expenditures as contained in subdivision 8 of "project" as defined in § 32.1-102.1 of the Code of Virginia or projects that involve relocation at the same site of 10 beds or 10% of the beds, whichever is less, from one existing physical facility to another, when the cost of such relocation is less than $5 million, shall be subject to an expedited review process.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 6.1, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; Volume 14, Issue 12, eff. April 2, 1998; Volume 19, Issue 8, eff. February 3, 2003; Volume 26, Issue 2, eff. November 1, 2009.

12VAC5-220-290 Application forms

A. Obtaining application forms. Application forms for an expedited review shall be available from the department upon the request of the applicant. The department shall transmit application forms to the applicant within seven days of receipt of such request.

B. Application fees. The department shall collect application fees for applications that request a certificate of public need under the expedited review process. No application will be reviewed until the required application fee is paid as provided in 12VAC5-220-180 B.

C. Filing application forms. All requests for a certificate of public need in accordance with the expedited review process shall be reviewed by the department and the regional health planning agency which shall each forward a recommendation to the commissioner within 40 days from the date the submitted application has been deemed complete. No application for expedited review shall be reviewed until the application form has been received by the department and the appropriate regional health planning agency, has been deemed complete, and the application fee has been paid to the department.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 6.2, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; Volume 14, Issue 12, eff. April 2, 1998.

12VAC5-220-300 Participation by other persons

Any person directly affected by the review of a project under the expedited review process may submit written opinions, data and other information to the appropriate regional health planning agency and to the commissioner prior to their final action.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 6.3, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994.

12VAC5-220-310 Action on application

A. Decisions to approve any project under the expedited review process shall be rendered by the commissioner within 45 days of the receipt of such completed request. The commissioner shall approve and issue a certificate for any project which is determined to meet the criteria for expedited review set forth in 12VAC5-220-280.

B. If the commissioner determines that a project does not meet the criteria for an expedited review set forth in 12VAC5-220-280, the applicant will be notified in writing of such determination within 45 days of the receipt of such request. In such cases, the department will forward the appropriate forms to the project applicant for use in filing an application for review of a project in the appropriate review cycle in accordance with Part V of this chapter.

C. Any project which does not qualify for an expedited review in accordance with 12VAC5-220-280, as determined by the commissioner, shall be exempted from the requirements of 12VAC5-220-180 A and B when such project is filed for consideration in accordance with Part V of this chapter.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 6.4, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994.

12VAC5-220-320 (Repealed.)

Historical Notes

Derived from VR355-30-000 § 7.1, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; repealed, Virginia Register Volume 13, Issue 7, eff. January 24, 1997.

Part VII New Nursing Home Bed Review Process

12VAC5-220-325 Applicability

The following categories of projects as determined by the State Health Commissioner shall be subject to the nursing home bed review process when they involve an increase in the number of nursing home facility beds in Virginia. (For Continuing Care Retirement Community nursing home beds, see Part V (12VAC5-220-170 et seq.) of this chapter.)

1. The establishment of a nursing home, intermediate care facility, or extended care facility, except when such nursing home, intermediate care facility, or extended care facility is proposed by a continuing care retirement community and the project is sponsored by a continuing care provider registered with the State Corporation Commission pursuant to Chapter 49 (§ 38.2-4900 et seq.) of Title 38.2 of the Code of Virginia.

2. An increase in the total number of beds in an existing or authorized nursing home, intermediate care facility, or extended care facility, except when the nursing home, intermediate care facility, or extended care facility is a component of a continuing care retirement community and the project is sponsored by a continuing care provider registered with the State Corporation Commission pursuant to Chapter 49 (§ 38.2-4900 et seq.) of Title 38.2 of the Code of Virginia.

3. An increase in the total number of nursing home beds, intermediate care facility beds, or extended care facility beds in an existing or authorized medical care facility which is not a dedicated nursing home, intermediate care facility, or extended care facility.

4. The introduction into any existing medical care facility of any new nursing home service such as intermediate care facility services, extended care facility services or skilled nursing facility services except when such medical care facility is an existing nursing home as defined in § 32.1-123 of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 7, eff. January 24, 1997.

12VAC5-220-330 (Repealed.)

Historical Notes

Derived from VR355-30-000 § 7.2, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; repealed, Virginia Register Volume 13, Issue 7, eff. January 24, 1997.

12VAC5-220-335 Request for Applications (RFA)

Pursuant to § 32.1-102.3:2 A, B, and C of the Code of Virginia, the commissioner shall periodically issue a Request for Applications (RFA). An RFA shall be issued at least annually.

A RFA from project applicants proposing projects which would result in an increase in the number of beds are provided shall be based on analyses of the need for increases in the bed supply in each of Virginia's planning districts in accordance with the applicable standards included in the State Medical Facilities Plan. Such RFAs shall also include a schedule for the review of applications submitted in response to the RFA which allows for at least 120 days between the day on which the RFA is issued and the first day of the review cycle for such applications.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 7, eff. January 24, 1997; amended, Virginia Register Volume 26, Issue 2, eff. November 1, 2009.

12VAC5-220-340 (Repealed.)

Historical Notes

Derived from VR355-30-000 § 7.3, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; repealed, Virginia Register Volume 13, Issue 7, eff. January 24, 1997.

12VAC5-220-345 Limitation on acceptance of RFA applications

Applications for projects listed in § 32.1-102.3:2 A, B, and C of the Code of Virginia shall only be accepted for review when properly filed in response to a RFA. Furthermore, the commissioner shall only accept for review applications which propose projects located in the planning districts from which applications are requested in the RFA and propose authorization of a number of new beds are provided which is less than or equal to the total number of beds identified as needed for the planning district in which the project will be located.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 7, eff. January 24, 1997; amended, Virginia Register Volume 26, Issue 2, eff. November 1, 2009.

12VAC5-220-350 (Repealed.)

Historical Notes

Derived from VR355-30-000 § 7.4, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; repealed, Virginia Register Volume 13, Issue 7, eff. January 24, 1997.

12VAC5-220-355 RFA project application forms

A. Letter of intent. A RFA project applicant shall file a letter of intent with the commissioner to request appropriate application forms, and submit a copy of that letter to the appropriate regional health planning agency by the letter of intent deadline specified in the RFA. The letter shall identify the owner, the type of project for which an application is requested, and the proposed scope (size) and location of the proposed project. The department shall transmit application forms to the applicant within seven days of the receipt of the letter of intent. A letter of intent filed with the department shall be considered void if an application is not filed for the project by the application deadline specified in the RFA.

B. Application fees. The department shall collect application fees for RFA applications that request a certificate of public need. The fee required for an application is 1.0% of the proposed capital expenditure for the project but no less than $1,000 and no more than $20,000. No application will be deemed to be complete for review until the required application fee is paid.

C. Filing application forms. Applications must be submitted to the department and the appropriate regional health planning agency by the application filing deadline specified in the RFA. In order to verify the department and the appropriate regional health planning agency's receipt of the application, the applicant shall transmit the document electronically, or prepare in triplicate two copies to be submitted to the department and one copy to be submitted to the appropriate regional health planning agency and sent by certified mail or a delivery service, return receipt requested, or by hand, with a signed receipt to be provided. No application shall be deemed to have been submitted until required copies have been received by the department and the appropriate regional health planning agency.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 7, eff. January 24, 1997; amended, Virginia Register Volume 19, Issue 8, eff. February 3, 2003; Volume 26, Issue 2, eff. November 1, 2009.

12VAC5-220-360 (Repealed.)

Historical Notes

Derived from VR355-30-000 § 8.1, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; repealed, Virginia Register Volume 13, Issue 7, eff. January 24, 1997.

12VAC5-220-365 Review for completeness

The applicant shall be notified by the department within 15 days following receipt of the application if additional information is required to complete the application or the application is complete as submitted. No application shall be reviewed until the department has determined that it is complete. To be complete, all questions and information items requested on the application must be completely addressed and the application fee submitted. Additional information required to complete an application shall be submitted to the department and the appropriate regional health planning agency at least five days prior to the first day of the review cycle, as specified in the RFA, to be considered in the review cycle.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 7, eff. January 24, 1997.

12VAC5-220-370 (Repealed.)

Historical Notes

Derived from VR355-30-000 § 9.1, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; repealed, Virginia Register Volume 13, Issue 7, eff. January 24, 1997.

12VAC5-220-375 Consideration of RFA applications

RFA applications proposed for the same planning district shall be considered as competing applications by the commissioner. The commissioner shall determine whether an application is competing and provide written notification to the competing applicants and the regional health planning agency.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 7, eff. January 24, 1997; amended, Virginia Register Volume 26, Issue 2, eff. November 1, 2009.

12VAC5-220-380 (Repealed.)

Historical Notes

Derived from VR355-30-000 § 9.2, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; repealed, Virginia Register Volume 13, Issue 7, eff. January 24, 1997.

12VAC5-220-385 Review of complete application

A. Review cycle. The department shall provide written notification to applicants specifying the acceptance date and review schedule of completed applications, including the date for any informal fact-finding conference that may be held between the eightieth and ninetieth day of the review cycle. The regional health planning agency shall conduct no more than two meetings, one of which must be a public hearing conducted by the regional health planning agency board or a subcommittee of the board and provide applicants with an opportunity, prior to the vote, to respond to any comments made about the project by the regional health planning agency staff, any information in a staff report, the comments of the local governing bodies in the health planning district, all other public comments, or comments by those voting in completing its review and recommendation by the sixtieth day of the cycle. By the seventieth day of the review cycle, the department shall complete its review and recommendation of an application and transmit the same to the applicant or applicants and other appropriate persons. By the seventy-fifth day of the review cycle, the department shall transmit to the applicants and other appropriate persons, its determination whether an informal fact-finding conference is necessary.

An informal fact-finding conference shall be held when (i) determined necessary by the department or (ii) requested by any person seeking to demonstrate good cause. Any person seeking to demonstrate good cause shall file, no later than four days after the department has completed its review and recommendation of an application and has transmitted the same to the applicants and to persons who have prior to the issuance of the report requested a copy in writing, written notification with the commissioner, applicant or applicants and other competing applicants, and regional health planning agency stating the grounds for good cause and providing the factual basis therefor under oath.

For purposes of this section, "good cause" means that (i) there is significant, relevant information not previously presented at and not available at the time of the public hearing, (ii) there have been significant changes in factors or circumstances relating to the application subsequent to the public hearing, or (iii) there is a substantial material mistake of fact or law in the department staff's report on the application or in the report submitted by the regional health planning agency. (See § 32.1-102.6 of the Code of Virginia.)

B. Time period for review. The review period shall begin on the first day of the applicable review cycle within which an application is determined to be complete, in accordance with scheduled batch review cycles described in 12VAC5-220-200. If the application is not determined to be complete for the applicable batch cycle within 40 calendar days from the date of submission, the application may be refiled in the next applicable batch cycle.

If the regional health planning agency has not completed its review by the sixtieth day of the review cycle, or such other period in accordance with the applicant's request for extension, and submitted its recommendation within ten calendar days after the completion of its review, the department shall, on the eleventh day after expiration of the regional health planning agency's review period, proceed as if the regional health planning agency has recommended approval of the proposed project.

In any case in which an informal fact-finding conference is not held, the project record shall be closed on the earlier of (i) the date established for holding the informal fact-finding conference or (ii) the date that the department determines that an informal fact-finding conference is not necessary. See 12VAC5 220-230 A.

In any case in which an informal fact-finding conference is held, a date shall be established for closing of the record which shall not be more than 30 calendar days after the date for holding the informal fact-finding conference.

C. Determination by the commissioner. If a determination whether a public need exists for a project is not made by the commissioner within 45 calendar days of the closing of the record, the commissioner shall notify the applicant or applicants and any person seeking to show good cause, in writing, that the application or the applications of each shall be deemed approved 25 calendar days after the expiration of such 45-calendar-day period, unless the receipt of recommendations from the person performing the hearing officer functions permits the commissioner to issue his case decision within that 25-calendar-day period. The validity or timeliness of the aforementioned notice shall not, in any event, prevent, delay or otherwise impact the effectiveness of this section.

In any case when a determination whether a public need exists for a project is not made by the commissioner within 70 calendar days after closing of the record, the application shall be deemed approved and a certificate shall be granted.

If a determination whether a public need for a project exists is not made by the commissioner within 45 calendar days of the closing of the record, any applicant who is competing in the relevant batch review cycle or who has filed an application in response to the relevant Request for Applications issued pursuant to 12VAC5-220-355 may, prior to the application being deemed approved petition for immediate injunctive relief pursuant to § 2.2-4030 of the Code of Virginia, naming as respondents the commissioner and all parties to the case. During the pendency of proceeding, no applications shall be deemed to be approved. In such a proceeding, the provisions of § 2.2-4030 of the Code of Virginia shall apply.

Deemed approvals shall be construed as the commissioner's case decision on the application pursuant to the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) and shall be subject to judicial review on appeal as the commissioner's case decision in accordance with such act.

Any person who has sought to participate in the department's review of such deemed-to-be-approved application as a person showing good cause who has not received a final determination from the commissioner concerning such attempt to show good cause petition prior to the date on which the application was approved, shall be deemed to be a person showing good cause for purposes of appeal of a deemed-to-be-approved certificate.

In any appeal of the commissioner's case decision granting a certificate of public need pursuant to a Request for Applications issued pursuant to § 32.1-102.3:2 of the Code of Virginia, the court may require the appellant to file a bond pursuant to § 8.01-676.1 of the Code of Virginia, in such sum as shall be fixed by the court for protection of all parties interested in the case decision, conditioned on the payment of all damages and costs incurred in consequence of such appeal.

The applicants, and only the applicants, shall have the authority to extend any of the time periods for review of the application, which are specified in 12VAC5-220-230. If all applicants consent to extending any time period in this section, the commissioner, with the concurrence of the applicants, shall establish a new schedule for the remaining time periods.

D. Regional health planning agency required notifications. Upon notification of the acceptance date of a complete application as set forth in subsection A of this section, the regional health planning agency shall provide written notification of its review schedule to the applicant. The regional health planning agency shall notify the local governing bodies in the planning district, health care providers and specifically identifiable consumer groups who may be affected by the proposed project directly by mail and shall also give notice of the public hearing in a newspaper of general circulation in such county or city wherein a project is proposed or a contiguous county or city at least nine days prior to such public hearing. Such notification by the regional health planning agency shall include: (i) the date and location of the public hearing which shall be conducted on the application except as otherwise provided in this chapter, in the county or city wherein a project is proposed or a contiguous county or city; and (ii) the date, time and place the final recommendation of the regional health planning agency shall be made. The regional health planning agency shall maintain a verbatim record of the public hearing that includes any comments of the local governing bodies of the health planning district and all other public comments. A copy of the verbatim record shall be provided to the department. Such public hearing record shall be maintained for at least a one-year time period following the final decision on a certificate of public need application. See definition of "public hearing."

E. Ex parte contact. After commencement of a public hearing and before a final decision is made, there shall be no ex parte contacts between the State Health Commissioner and any person acting on behalf of the applicant or holder of a certificate or any person opposed to the issuance or in favor of revocation of a certificate of public need, unless written notification has been provided. See definition of "ex parte."

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 7, eff. January 24, 1997; amended, Virginia Register Volume 14, Issue 12, eff. April 2, 1998; Volume 19, Issue 8, eff. February 3, 2003; Volume 20, Issue 26, eff. September 27, 2004.

12VAC5-220-390 (Repealed.)

Historical Notes

Derived from VR355-30-000 § 10.1, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; repealed, Virginia Register Volume 13, Issue 7, eff. January 24, 1997.

12VAC5-220-395 Participation by other persons

Any person affected by a proposed project under review may directly submit written opinions, data and other information to the appropriate regional health planning agency and the commissioner for consideration prior to their final action.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 7, eff. January 24, 1997.

12VAC5-220-400 (Repealed.)

Historical Notes

Derived from VR355-30-000 § 10.2, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; repealed, Virginia Register Volume 13, Issue 7, eff. January 24, 1997.

12VAC5-220-405 Amendment to an application

The applicant shall have the right to amend an application at any time. Any amendment which is made to an application following the public hearing and prior to the issuance of a certificate unless otherwise specified in this chapter shall constitute a new application and shall be subject to the review requirements set forth in this part of this chapter. If such amendment is made subsequent to the issuance of a certificate of public need, it shall be reviewed in accordance with 12VAC5-220-130.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 7, eff. January 24, 1997.

12VAC5-220-410 Withdrawal of an application

The applicant shall have the right to withdraw an application from consideration at any time without prejudice by written notification to the commissioner.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 7, eff. January 24, 1997.

12VAC5-220-420 Action on an application

A. Commission's responsibility. Decisions as to approval or disapproval of applications or a portion thereof for certificates of public need shall be rendered by the commissioner. Any decision to issue or approve the issuance of a certificate shall be consistent with the most recent applicable provisions of the State Medical Facilities Plan. However, if the commissioner finds, upon presentation of appropriate evidence, that the provisions of such plan are not relevant to a rural locality's needs, inaccurate, outdated, inadequate or otherwise inapplicable, the commissioner, consistent with such finding, may issue or approve the issuance of a certificate and shall initiate procedures to make appropriate amendments to such plan.

The commissioner may condition the approval of an application for a project (i) on the agreement by the applicant to provide an acceptable level of care at a reduced rate to indigents or, (ii) on the agreement of the applicant to provide care to persons with special needs, or (iii) upon the agreement of the applicant to facilitate the development and operation of primary medical care services in designated medically underserved areas of the applicant's service area. The terms of such agreements shall be specified in writing prior to the commissioner's decision to approve a project. Any person willfully refusing, failing or neglecting to honor such agreements shall be subject to a civil penalty of $100 per violation per day from the date of receipt from the department of written notice of noncompliance until the date of compliance. Upon information and belief that a person has failed to honor such agreement in accordance with this provision, the department shall notify the person in writing and 15 days shall be provided for a response in writing including a plan for immediate correction. In the absence of an adequate response or necessary compliance or both, a judicial action shall be initiated in accordance with the provisions of § 32.1-27 of the Code of Virginia.

B. Notification process – extension of review time. The commissioner shall make a final determination on an application for a certificate of public need and provide written notification detailing the reasons for such determination to the applicant with a copy to the regional health planning agency within the time frames specified in 12VAC5-220-385 B unless an authorization is given by the applicants to extend the time period. Such written notification shall also reference the factors and bases considered in making a decision on the application and, if applicable, the remedies available for appeal of such decision and the progress reporting requirements. The commissioner may approve a portion of a project provided the portion to be approved is agreed to by the applicant following consultation, which may be subject to the ex parte provision of this chapter, between the commissioner and the applicant.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 7, eff. January 24, 1997; amended, Virginia Register Volume 19, Issue 8, eff. February 3, 2003.

Part VIII Duration, Extension, and Revocation of Certificates

12VAC5-220-430 Duration

A certificate of public need shall be valid for a period of 12 months and shall not be transferrable from the certificate holder to any other legal entity regardless of the relationship, under any circumstances.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 7.1, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; recodified, Virginia Register Volume 13, Issue 7, eff. January 24, 1997.

12VAC5-220-440 Extension

A certificate of public need is valid for a 12-month period and may be extended by the commissioner for additional time periods which shall be specified at the time of the extension.

A. Basis for certificate extension within 24 months. An extension of a certificate of public need beyond the expiration date may be granted by the commissioner by submission of evidence to demonstrate that progress is being made towards the completion of the authorized project as defined in 12VAC5-220-450. Such request shall be submitted to the commissioner in writing with a copy to the appropriate regional health planning agency at least 30 days prior to the expiration date of the certificate or period of extension.

B. Basis for certificate extension beyond 24 months. An extension of a certificate of public need beyond the two years following the date of issuance may be granted by the commissioner when substantial and continuing progress is being made towards the development of the authorized project. In making the determination, the commissioner shall consider whether: (i) any delays in development of the project have been caused by events beyond the control of the owner; (ii) substantial delays in development of the project may not be attributed to the owner; and (iii) a schedule of completion has been provided and determined to be reasonable. Such request shall be submitted in writing with a copy to the appropriate regional health planning agency at least 30 days prior to the expiration date of the certificate of period of extension. The commissioner shall not grant an extension to the schedule for completion of a project beyond three years (36 months) of the date of certificate issuance or beyond the time period approved at the date of certificate issuance, whichever is greater, unless such extension is authorized in accordance with the provisions for a significant change. See 12VAC5-220-130, Significant change limitation.

C. Basis for indefinite extension. A certificate shall be considered for an indefinite extension by the commissioner when satisfactory completion of a project has been demonstrated as set forth in subsection C of 12VAC5-220-450.

D. Regional health planning agency review. All requests for an extension of a certificate of public need shall be reviewed by the appropriate regional health planning agency within 30 days of receipt by the department and the regional health planning agency. The recommendations on the request by that agency shall be forwarded to the commissioner who shall act upon the progress report within 35 days of receipt by the department and the regional health planning agency. Failure of the regional health planning agency to notify the commissioner within the time frame prescribed shall constitute a recommendation of approval by such regional health planning agency.

E. Notification of decision. Extension of a certificate of public need by the commissioner shall be made in the form of a letter from the commissioner with a copy to the appropriate regional health planning agency and shall become part of the official project file.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 7.2, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; recodified, Virginia Register Volume 13, Issue 7, eff. January 24, 1997.

12VAC5-220-450 Demonstration of progress

The applicant shall provide reports to demonstrate progress made towards the implementation of an authorized project in accordance with the schedule of development which shall be included in the application. Such progress reports shall be filed in accordance with the following intervals and contain such evidence as prescribed at each interval:

A. Twelve months following issuance. Documentation that shows: (i) proof of ownership or control of site; (ii) the site meets all zoning and land use requirements; (iii) architectural planning has been initiated; (iv) preliminary architectural drawings and working drawings have been submitted to appropriate state reviewing agencies and the State Fire Marshal; (v) construction financing has been completed or will be completed within two months and (vi) purchase orders or lease agreements exist for equipment and new service projects.

B. Twenty-four months following issuance. Documentation that shows that (i) all required financing is completed; (ii) preconstruction site work has been initiated; (iii) construction bids have been advertised and the construction contractor has been selected; (iv) the construction contract has been awarded and (v) construction has been initiated.

C. Upon completion of a project. Any documentation not previously provided which: (i) shows the final costs of the project, including the method(s) of financing; and (ii) shows that the project has been completed as proposed in accordance with the application originally submitted, including any subsequent approved changes. See "completion" as defined in 12VAC5-220-10.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 7.3, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; recodified, Virginia Register Volume 13, Issue 7, eff. January 24, 1997.

12VAC5-220-460 Revocation of certificate

A. Lack of progress. Failure of any project to meet the progress requirements stated in 12VAC5-220-450 shall be cause for certificate revocation, unless the commissioner determines sufficient justification exists to permit variance, considering factors enumerated in 12VAC5-220-450.

B. Failure to report progress. Failure of an applicant to file progress reports on an approved project in accordance with 12VAC5-220-450 shall be cause for revocation, unless, due to extenuating circumstances, the commissioner, in his sole discretion, extends the certificate, in accordance with subsection B of 12VAC5-220-440.

C. Unapproved changes. Exceeding a capital expenditure amount not authorized by the commissioner or not consistent with the schedule of completion shall be cause for revocation. See definition of "significant change" and "schedule of completion."

D. Failure to initiate construction. Failure to initiate construction of the project within two years following the date of issuance of the certificate of public need shall be cause for revocation, unless due to extenuating circumstances the commissioner extends the certificate, in accordance with subsection B of 12VAC5-220-440.

E. Misrepresentation. Upon determination that an applicant has knowingly misrepresented or knowingly withheld relevant data or information prior to issuance of a certificate of public need, the commissioner may revoke said certificate.

F. Noncompliance with assurances. Failure to comply with the assurances or intentions set forth in the application or written assurances provided at the time of issuance of a certificate of public need shall be cause for revocation.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 7.4, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; recodified, Virginia Register Volume 13, Issue 7, eff. January 24, 1997.

Part IX Appeals

12VAC5-220-470 Judicial review

Appeals to a circuit court shall be governed by the Virginia Administrative Process Act, § 2.2-4000 et seq. of the Code of Virginia, and Part Two A of the Rules of the Supreme Court of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 8.1, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; recodified, Virginia Register Volume 13, Issue 7, eff. January 24, 1997; amended, Virginia Register Volume 19, Issue 8, eff. February 3, 2003.

Part X Sanctions

12VAC5-220-480 Violation of rules and regulations

Commencing any project without a certificate required by this chapter shall constitute grounds for refusing to issue a license for such project.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 9.1, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; recodified, Virginia Register Volume 13, Issue 7, eff. January 24, 1997.

12VAC5-220-490 Injunctive relief

On petition of the commissioner, the Board of Health or the Attorney General, the circuit court of the county or city where a project is under construction or is intended to be constructed, located or undertaken shall have jurisdiction to enjoin any project which is constructed, undertaken or commenced without a certificate or to enjoin the admission of patients to the project or to enjoin the provision of services through the project.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-000 § 9.2, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; recodified, Virginia Register Volume 13, Issue 7, eff. January 24, 1997.

12VAC5-220-500 (Repealed.)

Historical Notes

Derived from VR355-30-000 § 10.1, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 17, eff. June 15, 1994; recodified, Virginia Register Volume 13, Issue 7, eff. January 24, 1997; amended, Virginia Register Volume 14, Issue 12, eff. April 2, 1998; repealed, Virginia Register Volume 28, Issue 4, eff. November 23, 2011.

Chapter 221 Regulations Governing Cooperative Agreements

Part II Application

12VAC5-221-65 Reimbursement

A. For each application recommended for approval by the authority, a review deposit of $50,000 shall be paid by the applicants to the department.

B. The review deposit shall be:

1. Remitted only by certified check, cashier's check, bank money order, or other methods approved by the commissioner;

2. Made payable to the department; and

3. Due to the department upon the commissioner's receipt of a recommendation for approval from the authority.

C. If the commissioner determines, after review of the application, that the actual cost incurred by the department is less than $50,000, the department shall reimburse the applicant the amount that is greater than the actual cost.

D. If the commissioner determines that the actual cost incurred by the department is greater than $50,000, the applicant shall pay any additional amount to be:

1. Remitted only by certified check, cashier's check, bank money order, or other methods approved by the commissioner;

2. Made payable to the department; and

3. Due to the department 30 days after receipt of a request for payment from the commissioner.

E. The commissioner shall:

1. Incur only those costs necessary to adequately review the application as determined in the commissioner's sole discretion; and

2. Maintain detailed records of all costs incurred for which reimbursement is sought.

F. An applicant seeking approval of a cooperative agreement shall reimburse the commissioner for all reasonable and actual costs incurred by the commissioner in the commissioner's review of the application, including costs of experts and consultants retained by the commissioner.

G. The applicants shall make payment to the department within 30 days of receipt of a request for reimbursement.

H. Prior to contracting with experts or consultants, the commissioner shall provide a seven-day notice to the applicants describing the proposed scope of work and anticipated costs of those experts and consultants.

I. The applicants shall have seven days from the date of receipt of the commissioner's notice pursuant to subsection H of this section to provide to the commissioner possible alternatives to the use of those experts and consultants.

J. The commissioner shall consider information submitted by the applicants in determining whether to retain an expert or consultant.

K. All reimbursement requests by the commissioner shall be subject to the provisions of § 2.2-4805 of the Code of Virginia.

History

• Statutory Authority: § 32.1-12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 42, Issue 8, eff. January 15, 2026.

12VAC5-221-95 Conditions

The commissioner may condition the approval of the authorization letter on the applicant's commitment to achieving improvements to population health, access to health care services, quality, and cost-effectiveness identified by the applicant in support of the application. The conditions may include:

1. A cap on the negotiated case-mix adjusted revenue per discharge by payer by product;

2. A commitment to return a portion of the cost savings and efficiencies gained through the cooperative agreement to residents in the participating localities through specific proposed mechanisms;

3. An agreement that the parties may not prevent or discourage health plans from directing or incentivizing patients to choose certain providers;

4. An agreement that the parties may not have any contractual clauses or provisions that prevent health plans from directing or incentivizing patients;

5. An agreement that the parties may not engage in the typing of sales of the health system's services with the health plan purchase of other services from the health system;

6. An agreement that the parties may not restrict a health plan's ability to make available to its health plan enrollees cost, quality, efficiency, and performance information to aid enrollees in evaluating and selecting providers in the health plan;

7. A commitment that the parties may not refuse to include certain provisions in contracts with health plans that have been utilized in health plan contracts in other parts of the Commonwealth in order to promote value-based health care, including bundled payments, pay for performance, utilization management, and other processes that reward improvements in quality and efficiency; and

8. A commitment to reduce the total cost of care and improve the quality of care in the region served by the new entity.

History

• Statutory Authority: § of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 42, Issue 8, eff. January 15, 2026.

Part III Monitoring

12VAC5-221-115 Onsite inspection

A. The commissioner may make periodic unannounced onsite inspections of the party's facilities as necessary.

B. The commissioner may designate the department to conduct onsite inspections or investigations of the party's facilities.

C. The party shall make available to the commissioner requested records and shall allow access to interview the agents, employees, contractors, and any other person under control, direction, or supervision of the party.

D. The commissioner shall investigate complaints received regarding noncompliance with the cooperative agreement or the authorization letter.

E. When the investigation is complete, the commissioner shall notify the party and the complainant, if known, of the findings of the investigation.

History

• Statutory Authority: § of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 42, Issue 8, eff. January 15, 2026.

Chapter 230 State Medical Facilities Plan

Part I Definitions and General Information

12VAC5-230-10 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Acute psychiatric services" means hospital-based inpatient psychiatric services provided in distinct inpatient units in general hospitals or freestanding psychiatric hospitals.

"Acute substance abuse disorder treatment services" means short-term hospital-based inpatient treatment services with access to the resources of (i) a general hospital, (ii) a psychiatric unit in a general hospital, (iii) an acute care addiction treatment unit in a general hospital licensed by the Department of Health, or (iv) a chemical dependency specialty hospital with acute care medical and nursing staff and life support equipment licensed by the Department of Behavioral Health and Developmental Services.

"Bassinet" means an infant care station, including warming stations and isolettes.

"Bed" means that unit, within the complement of a medical care facility, subject to COPN review as required by Article 1.1 (§ 32.1-102.1 et seq.) of the Code of Virginia and designated for use by patients of the facility or service. For the purposes of this chapter, bed does include cribs and bassinets used for pediatric patients but does not include cribs and bassinets in the newborn nursery or neonatal special care setting.

"Cardiac catheterization" means an invasive procedure where a flexible tube is inserted into the patient through an extremity blood vessel and advanced under fluoroscopic guidance into the heart chambers or coronary arteries. A cardiac catheterization may be conducted for diagnostic or therapeutic purposes but does not include a simple right heart catheterization for monitoring purposes as might be performed in an electrophysiology laboratory, pulmonary angiography as an isolated procedure, or cardiac pacing through a right electrode catheter.

"Commissioner" means the State Health Commissioner.

"Competing applications" means applications for the same or similar services and facilities that are proposed for the same health planning district, or same health planning region for projects reviewed on a regional basis, and are in the same batch review cycle.

"Complex therapeutic cardiac catheterization" means the performance of cardiac catheterization for the purpose of correcting or improving certain conditions that have been determined to exist in the heart or great arteries or veins of the heart, specifically catheter-based procedures for structural treatment to correct congenital or acquired structural or valvular abnormalities.

"Computed tomography" or "CT" means a noninvasive diagnostic technology that uses computer analysis of a series of cross-sectional scans made along a single axis of a bodily structure or tissue to construct an image of that structure.

"Continuing care retirement community" or "CCRC" means a retirement community consistent with the requirements of Chapter 49 (§ 38.2-4900 et seq.) of Title 38.2 of the Code of Virginia.

"COPN" means a Medical Care Facilities Certificate of Public Need for a project as required in Article 1.1 (§ 32.1-102.1 et seq.) of Chapter 4 of Title 32.1 of the Code of Virginia.

"COPN program" means the Medical Care Facilities Certificate of Public Need Program implementing Article 1.1 (§ 32.1-102.1 et seq.) of Chapter 4 of Title 32.1 of the Code of Virginia.

"DEP" means diagnostic equivalent procedure, a method for weighing the relative value of various cardiac catheterization procedures as follows: a diagnostic cardiac catheterization equals 1 DEP, a simple therapeutic cardiac catheterization equals 2 DEPs, a same session procedure (diagnostic and simple therapeutic) equals 3 DEPs, and a complex therapeutic cardiac catheterization equals 5 DEPs. A multiplier of 2 will be applied for a pediatric procedure (i.e., a pediatric diagnostic cardiac catheterization equals 2 DEPs, a pediatric simple therapeutic cardiac catheterization equals 4 DEPs, and a pediatric complex therapeutic cardiac catheterization equals 10 DEPs.)

"Diagnostic cardiac catheterization" means the performance of cardiac catheterization for the purpose of detecting and identifying defects in the great arteries or veins of the heart or abnormalities in the heart structure, whether congenital or acquired.

"Direction" means guidance, supervision, or management of a function or activity.

"Gamma knife®" means the name of a specific instrument used in stereotactic radiosurgery.

"Health planning district" means the same contiguous areas designated as planning districts by the Virginia Department of Housing and Community Development or its successor.

"Health planning region" means a contiguous geographic area of the Commonwealth as designated by the State Board of Health with a population base of at least 500,000 persons, characterized by the availability of multiple levels of medical care services, reasonable travel time for tertiary care, and congruence with planning districts.

"Health system" means an organization of two or more medical care facilities, including hospitals, that are under common ownership or control and are located within the same health planning district, or health planning region for projects reviewed on a regional basis.

"Hospital" means a medical care facility licensed as an inpatient hospital or outpatient surgical center by the Department of Health or as a psychiatric hospital by the Department of Behavioral Health, and Developmental Services.

"ICF/MR" means an intermediate care facility for the mentally retarded.

"Indigent" means any person whose gross family income is equal to or less than 200% of the federal Nonfarm Poverty Level or income levels A through E of 12VAC5-200-10 and who is uninsured.

"Inpatient" means a patient who is hospitalized longer than 24 hours for health or health related services.

"Intensive care beds" or "ICU" means inpatient beds located in the following units or categories:

1. General intensive care units are those units where patients are concentrated by reason of serious illness or injury regardless of diagnosis. Special lifesaving techniques and equipment are immediately available and patients are under continuous observation by nursing staff;

2. Cardiac care units, also known as Coronary Care Units or CCUs, are units staffed and equipped solely for the intensive care of cardiac patients; and

3. Specialized intensive care units are any units with specialized staff and equipment for the purpose of providing care to seriously ill or injured patients based on age selected categories of diagnoses, including units established for burn care, trauma care, neurological care, pediatric care, and cardiac surgery recovery but does not include bassinets in neonatal special care units.

"Lithotripsy" means a noninvasive therapeutic procedure to (i) crush renal and biliary stones using shock waves (i.e., renal lithotripsy) or (ii) treat certain musculoskeletal conditions and relieve the pain associated with tendonitis (i.e., orthopedic lithotripsy).

"Long-term acute care hospital" or "LTACH" means an inpatient hospital that provides care for patients who require a length of stay greater than 25 days and is, or proposes to be, certified by the Centers for Medicare and Medicaid Services as a long-term care inpatient hospital pursuant to 42 CFR Part 412. An LTACH may be either a freestanding facility or located within an existing or host hospital.

"Magnetic resonance imaging" or "MRI" means a noninvasive diagnostic technology using a nuclear spectrometer to produce electronic images of specific atoms and molecular structures in solids, especially human cells, tissues and organs.

"Medical rehabilitation" means those services provided consistent with 42 CFR 412.23 nd 412.24.

"Medical/surgical" means those services available for the care and treatment of patients not requiring specialized services.

"Minimum survival rates" means the base percentage of transplant recipients who survive at least one year or for such other period of time as specified by the United Network for Organ Sharing (UNOS).

"Neonatal special care" means care for infants in one or more of the higher service levels designated in 12VAC5-410-443 .

"Nursing facility" means those facilities or components thereof licensed to provide long-term nursing care.

"Obstetrical services" means the distinct organized program, equipment and care related to pregnancy and the delivery of newborns in inpatient facilities.

"Off-site replacement" means the relocation of existing beds or services from an existing medical care facility site to another location within the same health planning district.

"Open heart surgery" means a surgical procedure requiring the use or immediate availability of a heart-lung bypass machine or "pump." The use of the pump during the procedure distinguishes "open heart" from "closed heart" surgery.

"Operating room" means a room used solely or principally for the provision of surgical procedures involving the administration of anesthesia, multiple personnel, recovery room access, and a fully controlled environment.

"Operating room use" means the amount of time a patient occupies an operating room and includes room preparation and cleanup time.

"Operating room visit" means one session in one operating room in an inpatient hospital or outpatient surgical center, which may involve several procedures. Operating room visit may be used interchangeably with "operation" or "case."

"Outpatient" means a patient who visits a hospital, clinic, or associated medical care facility for diagnosis or treatment, but is not hospitalized 24 hours or longer.

"Pediatric" means patients younger than 18 years of age. Newborns in nurseries are excluded from this definition.

"Perinatal services" means those resources and capabilities that all hospitals offering general level newborn services as described in 12VAC5-410-443 must provide routinely to newborns.

"PET/CT scanner" means a single machine capable of producing a PET image with a concurrently produced CT image overlay to provide anatomic definition to the PET image. For the purpose of granting a COPN, the State Board of Health pursuant to § 32.1-102.2 A 6 of the Code of Virginia has designated PET/CT as a specialty clinical service. A PET/CT scanner shall be reviewed under the PET criteria as an enhanced PET scanner unless the CT unit will be used independently. In such cases, a PET/CT scanner that will be used to take independent PET and CT images will be reviewed under the applicable PET and CT services criteria.

"Planning horizon year" means the particular year for which bed or service needs are projected.

"Population" means the census figures shown in the most current series of projections published by a demographic entity as determined by the commissioner.

"Positron emission tomography" or "PET" means a noninvasive diagnostic or imaging modality using the computer-generated image of local metabolic and physiological functions in tissues produced through the detection of gamma rays emitted when introduced radionuclides decay and release positrons. A PET device or scanner may include an integrated CT to provide anatomic structure definition.

"Primary service area" means the geographic territory from which 75% of the patients of an existing medical care facility originate with respect to a particular service being sought in an application.

"Procedure" means a study or treatment or a combination of studies and treatments identified by a distinct ICD-10 or CPT code performed in a single session on a single patient.

"Qualified" means meeting current legal requirements of licensure, registration, or certification in Virginia or having appropriate training, including competency testing, and experience commensurate with assigned responsibilities.

"Radiation therapy" means treatment using ionizing radiation to destroy diseased cells and for the relief of symptoms. Radiation therapy may be used alone or in combination with surgery or chemotherapy.

"Relevant reporting period" means the most recent 12-month period, prior to the beginning of the applicable batch review cycle, for which data is available from VHI or a demographic entity as determined by the commissioner.

"Rural" means territory, population, and housing units that are classified as "rural" by the Bureau of the Census of the U.S. Department of Commerce, Economic and Statistics Administration.

"Simple therapeutic cardiac catheterization" means the performance of cardiac catheterization for the purpose of correcting or improving certain conditions that have been determined to exist in the heart, specifically catheter-based treatment procedures for relieving coronary artery narrowing.

"SMFP" means the state medical facilities plan as contained in Article 1.1 (§ 32.1-102.1 et seq.) of Chapter 4 of Title 32.1 of the Code of Virginia used to make medical care facilities and services needs decisions.

"Stereotactic radiosurgery" or "SRS" means the use of external radiation in conjunction with a stereotactic guidance device to very precisely deliver a therapeutic dose to a tissue volume. SRS may be delivered in a single session or in a fractionated course of treatment up to five sessions.

"Stereotactic radiotherapy" or "SRT" means more than one session of stereotactic radiosurgery.

"Substance abuse disorder treatment services" means services provided to individuals for the prevention, diagnosis, treatment, or palliation of chemical dependency, which may include attendant medical and psychiatric complications of chemical dependency. Substance abuse disorder treatment services are licensed by the Department of Behavioral Health, and Developmental Services.

"Supervision" means to direct and watch over the work and performance of others.

"Use rate" means the rate at which an age cohort or the population uses medical facilities and services. The rates are determined from periodic patient origin surveys conducted for the department by the regional health planning agencies or other health statistical reports authorized by Chapter 7.2 (§ 32.1-276.2 et seq.) of Title 32.1 of the Code of Virginia.

"VHI" means the health data organization defined in § 32.1-276.4 of the Code of Virginia and under contract with the Virginia Department of Health.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-100 § 1, eff. July 1, 1993; amended, Virginia Register Volume 19, Issue 8, eff. February 3, 2003; Volume 25, Issue 9, eff. February 15, 2009; Errata, 25:11 VA.R. 2018 February 2, 2009; amended, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC5-230-20 (Repealed.)

History

• Historical Notes: Derived from VR355-30-100 § 2, eff. July 1, 1993; amended, Virginia Register Volume 19, Issue 8, eff. February 3, 2003; repealed, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-30 Guiding principles in the development of project review criteria and standards

The following general principles serve as the basis for the development of the review criteria and standards for specific medical care facilities and services contained in this document:

1. The COPN program is based on the understanding that excess capacity or underutilization of medical facilities are detrimental to both cost effectiveness and quality of medical services in Virginia.

2. The COPN program seeks the geographical distribution of medical facilities and to promote the availability and accessibility of proven technologies.

3. The COPN program seeks to promote the development and maintenance of services and access to those services by every person who needs them without respect to their ability to pay.

4. The COPN program seeks to encourage the conversion of facilities to new and efficient uses and the reallocation of resources to meet evolving community needs.

5. The COPN program discourages the proliferation of services that would undermine the ability of essential community providers to maintain their financial viability.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from VR355-30-100 § 3, eff. July 1, 1993; amended, Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-40 General application filing criteria

A. In addition to meeting the applicable requirements of this chapter, applicants for a Certificate of Public Need shall include documentation in their application that their project addresses the applicable requirements listed in § 32.1-102.3 of the Code of Virginia.

B. The burden of proof shall be on the applicant to produce information and evidence that the project is consistent with the applicable requirements and review policies as required under Article 1.1 (§ 32.1-102.1 et seq.) of Chapter 4 of Title 32.1 of the Code of Virginia.

C. The commissioner may condition the approval of a COPN by requiring an applicant to: (i) provide a level of care at a reduced rate to indigents, (ii) accept patients requiring specialized care, or (iii) facilitate the development and operation of primary medical care services in designated medically underserved areas of the applicant's service area. The applicant must actively seek to comply with the conditions place on any granted COPN.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-50 Project costs

The capital development costs of a facility and the operating expenses of providing the authorized services should be comparable to the costs and expenses of similar facilities with the health planning region.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-60 When competing applications received

In reviewing competing applications, preference may be given to an applicant who:

1. Has an established performance record in completing projects on time and within the authorized operating expenses and capital costs;

2. Has both lower capital costs and operating expenses than his competitors and can demonstrate that his estimates are credible;

3. Can demonstrate a consistent compliance with state licensure and federal certification regulations and a consistent history of few documented complaints, where applicable; or

4. Can demonstrate a commitment to serving his community or service area as evidenced by unreimbursed services to the indigent and providing needed but unprofitable services, taking into account the demands of the particular service area.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009; Errata, 25:11 VA.R. 2018 February 2, 2009.

12VAC5-230-70 Calculation of utilization of services provided with mobile equipment

A. The minimum service volume of a mobile unit shall be prorated on a site-by-site basis reflecting the amount of time that proposed mobile units will be used, and existing mobile units have been used, during the relevant reporting period, at each site using the following formula:

| Required full-time minimum service volume | X | Number of days the service will be on site each week | X 0.2 = | Prorated minimum services volume (not to exceed the required full-time minimum service volume) | | --- | --- | --- | --- | --- |

B. The average annual utilization of existing and approved CT, MRI, PET, lithotripsy, and catheterization services in a health planning district shall be calculated for such services as follows:

| ( | Total volume of all units of the relevant service in the reporting period | ) X 100 = % Average Utilization | | | | | | --- | --- | --- | --- | --- | --- | --- | | ( | # of existing or approved fixed units | X | Fixed unit minimum service volume | ) + Y Utilization | | | | | | | | | | |

Y = the sum of the minimum service volume of each mobile site in the health planning district with the minimum services volume for each such site prorated according to subsection A of this section.

C. This section does not prohibit an applicant from seeking to obtain a COPN for a fixed site service provided capacity for the services has been achieved as described in the applicable service section.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009; Errata, 25:11 VA.R. 2018 February 2, 2009.

12VAC5-230-80 When institutional expansion needed

A. Notwithstanding any other provisions of this chapter, the commissioner may grant approval for the expansion of services at an existing medical care facility in a health planning district with an excess supply of such services when the proposed expansion can be justified on the basis of a facility's need having exceeded its current service capacity to provide such service or on the geographic remoteness of the facility.

B. If a facility with an institutional need to expand is part of a health system, the underutilized services at other facilities within the health system should be reallocated, when appropriate, to the facility with the institutional need to expand before additional services are approved for the applicant. However, underutilized services located at a health system's geographically remote facility may be disregarded when determining institutional need for the proposed project.

C. This section is not applicable to nursing facilities pursuant to § 32.1-102.3:2 of the Code of Virginia.

D. Applicants shall not use this section to justify a need to establish new services.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009; Errata, 25:11 VA.R. 2018 February 2, 2009.

12VAC5-230-90 Travel time

Article 1 Criteria and Standards for Computed Tomography

CT services should be within 30 minutes driving time one way under normal conditions of 95% of the population of the health planning district using a mapping software as determined by the commissioner.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-100 Need for new fixed site or mobile service

A. No new fixed site or mobile CT service should be approved unless fixed site CT services in the health planning district performed an average of 7,400 procedures per existing and approved CT scanner during the relevant reporting period and the proposed new service would not significantly reduce the utilization of existing providers in the health planning district. The utilization of existing scanners operated by a hospital and serving an area distinct from the proposed new service site may be disregarded in computing the average utilization of CT scanners in such health planning district.

B. Existing CT scanners used solely for simulation with radiation therapy treatment shall be exempt from the utilization criteria of this article when applying for a COPN. In addition, existing CT scanners used solely for simulation with radiation therapy treatment may be disregarded in computing the average utilization of CT scanners in such health planning district.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-110 Expansion of fixed site service

Proposals to expand an existing medical care facility's CT service through the addition of a CT scanner should be approved when the existing services performed an average of 7,400 procedures per scanner for the relevant reporting period. The commissioner may authorize placement of a new unit at the applicant's existing medical care facility or at a separate location within the applicant's primary service area for CT services, provided the proposed expansion is not likely to significantly reduce the utilization of existing providers in the health planning district.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009; Errata, 25:11 VA.R. 2018 February 2, 2009.

12VAC5-230-120 Adding or expanding mobile CT services

A. Proposals for mobile CT scanners shall demonstrate that, for the relevant reporting period, at least 4,800 procedures were performed and that the proposed mobile unit will not significantly reduce the utilization of existing CT providers in the health planning district.

B. Proposals to convert authorized mobile CT scanners to fixed site scanners shall demonstrate that, for the relevant reporting period, at least 6,000 procedures were performed by the mobile scanner and that the proposed conversion will not significantly reduce the utilization of existing CT providers in the health planning district.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-130 Staffing

CT services should be under the direction or supervision of one or more qualified physicians.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 2 Criteria and Standards for Magnetic Resonance Imaging

12VAC5-230-140 Travel time

Article 2 Criteria and Standards for Magnetic Resonance Imaging

MRI services should be within 30 minutes driving time one way under normal conditions of 95% of the population of the health planning district using a mapping software as determined by the commissioner.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-150 Need for new fixed site service

No new fixed site MRI services should be approved unless fixed site MRI services in the health planning district performed an average of 5,000 procedures per existing and approved fixed site MRI scanner during the relevant reporting period and the proposed new service would not significantly reduce the utilization of existing fixed site MRI providers in the health planning district. The utilization of existing scanners operated by a hospital and serving an area distinct from the proposed new service site may be disregarded in computing the average utilization of MRI scanners in such health planning district.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-160 Expansion of fixed site service

Proposals to expand an existing medical care facility's MRI services through the addition of an MRI scanner may be approved when the existing service performed an average of 5,000 MRI procedures per scanner during the relevant reporting period. The commissioner may authorize placement of the new unit at the applicant's existing medical care facility, or at a separate location within the applicant's primary service area for MRI services, provided the proposed expansion is not likely to significantly reduce the utilization of existing providers in the health planning district.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-170 Adding or expanding mobile MRI services

A. Proposals for mobile MRI scanners shall demonstrate that, for the relevant reporting period, at least 2,400 procedures were performed and that the proposed mobile unit will not significantly reduce the utilization of existing MRI providers in the health planning district.

B. Proposals to convert authorized mobile MRI scanners to fixed site scanners shall demonstrate that, for the relevant reporting period, 3,000 procedures were performed by the mobile scanner and that the proposed conversion will not significantly reduce the utilization of existing MRI providers in the health planning district.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-180 Staffing

MRI services should be under the direct supervision of one or more qualified physicians.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 3 Magnetic Source Imaging

12VAC5-230-190 Policy for the development of MSI services

Article 3 Magnetic Source Imaging

Because Magnetic Source Imaging (MSI) scanning systems are still in the clinical research stage of development with no third-party payment available for clinical applications, and because it is uncertain as to how rapidly this technology will reach a point where it is shown to be clinically suitable for widespread use and distribution on a cost-effective basis, it is preferred that the entry and development of this technology in Virginia should initially occur at or in affiliation with, the academic medical centers in the state.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 4 Positron Emission Tomography

12VAC5-230-200 Travel time

Article 4 Positron Emission Tomography

PET services should be within 60 minutes driving time one way under normal conditions of 95% of the health planning district using a mapping software as determined by the commissioner.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-210 Need for new fixed site service

A. If the applicant is a hospital, whether free-standing or within a hospital system, 850 new PET appropriate cases shall have been diagnosed and the hospital shall have provided radiation therapy services with specific ancillary services suitable for the equipment before a new fixed site PET service should be approved for the health planning district.

B. No new fixed site PET services should be approved unless an average of 6,000 procedures per existing and approved fixed site PET scanner were performed in the health planning district during the relevant reporting period and the proposed new service would not significantly reduce the utilization of existing fixed site PET providers in the health planning district . The utilization of existing scanners operated by a hospital and serving an area distinct from the proposed new service site may be disregarded in computing the average utilization of PET units in such health planning district.

Note: For the purposes of tracking volume utilization, an image taken with a PET/CT scanner that takes concurrent PET/CT images shall be counted as one PET procedure. Images made with PET/CT scanners that can take PET or CT images independently shall be counted as individual PET procedures and CT procedures respectively, unless those images are made concurrently.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-220 Expansion of fixed site services

Proposals to increase the number of PET scanners in an existing PET service should be approved only when the existing scanners performed an average of 6,000 procedures for the relevant reporting period and the proposed expansion would not significantly reduce the utilization of existing fixed site providers in the health planning district.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-230 Adding or expansing mobile PET or PET/CT services

A. Proposals for mobile PET or PET/CT scanners should demonstrate that, for the relevant reporting period, at least 230 PET or PET/CT appropriate patients were seen and that the proposed mobile unit will not significantly reduce the utilization of existing providers in the health planning district.

B. Proposals to convert authorized mobile PET or PET/CT scanners to fixed site scanners should demonstrate that, for the relevant reporting period, at least 1,400 procedures were performed by the mobile scanner and that the proposed conversion will not significantly reduce the utilization of existing providers in the health planning district .

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-240 Staffing

PET services should be under the direction or supervision of one or more qualified physicians. Such physicians shall be designated or authorized by the Nuclear Regulatory Commission or licensed by the Division of Radiologic Health of the Virginia Department of Health, as applicable.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 5 Noncardiac Nuclear Imaging Criteria and Standards

12VAC5-230-250 Travel time

Article 5 Noncardiac Nuclear Imaging Criteria and Standards

Noncardiac nuclear imaging services should be available within 30 minutes driving time one way under normal driving conditions of 95% of the population of the health planning district using a mapping software as determined by the commissioner.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-260 Need for new service

No new noncardiac imaging services should be approved unless the service can achieve a minimum utilization level of:

1. 650 procedures in the first 12 months of operation;

2. 1,000 procedures in the second 12 months of service; and

3. The proposed new service would not significantly reduce the utilization of existing providers in the health planning district.

Note: The utilization of an existing service operated by a hospital and serving an area distinct from the proposed new service site may be disregarded in computing the average utilization of noncardiac nuclear imaging services in such health planning district.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-270 Staffing

The proposed new or expanded noncardiac nuclear imaging service should be under the direction or supervision of one or more qualified physicians designated or authorized by the Nuclear Regulatory Commission or the Division of Radiologic Health of the Virginia Department of Health, as applicable.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 1 Radiation Therapy Services

12VAC5-230-280 Travel time

Article 1 Radiation Therapy Services

Radiation therapy services should be available within 60 minutes driving time one way under normal conditions of 95% of the population of the health planning district using a mapping software as determined by the commissioner.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-290 Need for new service

A. No new radiation therapy service should be approved unless:

1. Existing radiation therapy machines located in the health planning district performed an average of 8,000 procedures per existing and approved radiation therapy machine in the relevant reporting period; and

2. The new service will perform at least 5,000 procedures by the second year of operation without significantly reducing the utilization of existing providers in the health planning district.

B. The number of radiation therapy machines needed in a health planning district will be determined as follows:

| | Population x Cancer Incidence Rate x 60% | | --- | --- | | | 320 |

where:

1. The population is projected to be at least 150,000 people three years from the current year as reported in the most current projections of a demographic entity as determined by the commissioner;

2. The cancer incidence rate as determined by data from the Statewide Cancer Registry;

3. 60% is the estimated number of new cancer cases in a health planning district that are treatable with radiation therapy; and

4. 320 is 100% utilization of a radiation therapy machine based upon an anticipated average of 25 procedures per case.

C. Proposals for new radiation therapy services located less than 60 minutes driving time one way, under normal conditions, from any site that radiation therapy services are available shall demonstrate that the proposed new services will perform an average of 4,500 procedures annually by the second year of operation, without significantly reducing the utilization of existing services in the health planning district.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-300 Expansion of service

Proposals to expand radiation therapy services should be approved only when all existing radiation therapy services operated by the applicant in the health planning district have performed an average of 8,000 procedures for the relevant reporting period and the proposed expansion would not significantly reduce the utilization of existing providers.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-310 Statewide Cancer Registry

Facilities with radiation therapy services shall participate in the Statewide Cancer Registry as required by Article 9 (§ 32.1-70 et seq.) of Chapter 2 of Title 32.1 of the Code of Virginia.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-320 Staffing

Radiation therapy services should be under the direction or supervision of one or more qualified physicians designated or authorized by the Nuclear Regulatory Commission or the Division of Radiologic Health of the Virginia Department of Health, as applicable.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 2 Criteria and Standards for Stereotactic Radiosurgery

12VAC5-230-330 Travel time

Article 2 Criteria and Standards for Stereotactic Radiosurgery

Stereotactic radiosurgery services should be available within 60 minutes driving time one way under normal conditions of 95% of the population of a health planning region using a mapping software as determined by the commissioner.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-340 Need for new service

A. No new stereotactic radiosurgery services should be approved unless:

1. The number of procedures performed with existing units in the health planning region averaged more than 350 per year in the relevant reporting period; and

2. The proposed new service will perform at least 250 procedures in the second year of operation without significantly reducing the utilization of existing providers in the health planning region.

B. Preference may be given to a project that incorporates stereotactic radiosurgery service incorporated within an existing standard radiation therapy service using a linear accelerator when an average of 8,000 procedures during the relevant reporting period and utilization of existing services in the health planning region will not be significantly reduced.

C. Preference may be given to a project that incorporates a dedicated Gamma Knife® within an existing radiation therapy service when:

1. At least 350 Gamma Knife® appropriate cases were referred out of the region in the relevant reporting period; and

2. The applicant can demonstrate that:

a. An average of 250 procedures will be preformed in the second year of operation; and

b. Utilization of existing services in the health planning region will not be significantly reduced.

D. Preference may be given to a project that incorporates non-Gamma Knife® SRS technology within an existing radiation therapy service when:

1. The unit is not part of a linear accelerator;

2. An average of 8,000 radiation procedures per year were performed by the existing radiation therapy services;

3. At least 250 procedures will be performed within the second year of operation; and

4. Utilization of existing services in the health planning region will not be significantly reduced.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009; Errata, 25:11 VA.R. 2018 February 2, 2009.

12VAC5-230-350 Expansion of service

Proposals to increase the number of stereotactic radiosurgery services should be approved only when all existing stereotactic radiosurgery machines in the health planning region have performed an average of 350 procedures per existing and approved unit for the relevant reporting period and the proposed expansion would not significantly reduce the utilization of existing providers in the health planning region.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-360 Statewide Cancer Registry

Facilities with stereotactic radiosurgery services shall participate in the Statewide Cancer Registry as required by Article 9 (§ 32.1-70 et seq.) of Chapter 2 of Title 32.1 of the Code of Virginia.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-370 Staffing

Stereotactic radiosurgery services should be under the direction or supervision of one or more qualified physicians.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 1 Criteria and Standards for Cardiac Catheterization Services

12VAC5-230-380 Travel time

Article 1 Criteria and Standards for Cardiac Catheterization Services

Cardiac catheterization services should be within 60 minutes driving time one way under normal conditions of 95% of the population of the health planning district using mapping software as determined by the commissioner.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-390 Need for new service

A. No new fixed site cardiac catheterization service should be approved for a health planning district unless:

1. Existing fixed site cardiac catheterization services located in the health planning district performed an average of 1,200 cardiac catheterization DEPs per existing and approved laboratory for the relevant reporting period;

2. The proposed new service will perform an average of 200 DEPs in the first year of operation and 500 DEPs in the second year of operation; and

3. The utilization of existing services in the health planning district will not be significantly reduced.

B. Proposals for mobile cardiac catheterization laboratories should be approved only if such laboratories will be provided at a site located on the campus of an inpatient hospital. Additionally, applicants for proposed mobile cardiac catheterization laboratories shall be able to project that they will perform an average of 200 DEPs in the first year of operation and 350 DEPs in the second year of operation without significantly reducing the utilization of existing laboratories in the health planning district below 1,200 procedures.

C. Preference may be given to a project that locates new cardiac catheterization services at an inpatient hospital that is 60 minutes or more driving time one way under normal conditions from existing services if the applicant can demonstrate that the proposed new laboratory will perform an average of 200 DEPs in the first year of operation and 400 DEPs in the second year of operation without significantly reducing the utilization of existing laboratories in the health planning district.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-400 Expansion of services

Proposals to increase cardiac catheterization services should be approved only when:

1. All existing cardiac catheterization laboratories operated by the applicant's facilities where the proposed expansion is to occur have performed an average of 1,200 DEPs per existing and approved laboratory for the relevant reporting period; and

2. The applicant can demonstrate that the expanded service will achieve an average of 200 DEPs per laboratory in the first 12 months of operation and 400 DEPs in the second 12 months of operation without significantly reducing the utilization of existing cardiac catheterization laboratories in the health planning district.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-410 Pediatric cardiac catheterization

No new or expanded pediatric cardiac catheterization services should be approved unless:

1. The proposed service will be provided at an inpatient hospital with open heart surgery services, pediatric tertiary care services or specialty or subspecialty level neonatal special care;

2. The applicant can demonstrate that the proposed laboratory will perform at least 100 pediatric cardiac catheterization procedures in the first year of operation and 200 pediatric cardiac catheterization procedures in the second year of operation; and

3. The utilization of existing pediatric cardiac catheterization laboratories in the health planning district will not be reduced below 100 procedures per year.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-420 Nonemergent cardiac catheterization

A. Simple therapeutic cardiac catheterization. Proposals to provide simple therapeutic cardiac catheterization are not required to offer open heart surgery service available on-site in the same hospital in which the proposed simple therapeutic service will be located. However, these programs shall adhere to the requirements described in subdivisions 1 through 9 of this subsection.

The programs shall:

1. Participate in the Virginia Heart Attack Coalition, the Virginia Cardiac Services Quality Initiative, and the Action Registry-Get with the Guidelines or National Cardiovascular Data Registry to monitor quality and outcomes;

2. Adhere to strict patient-selection criteria;

3. Perform annual institutional volumes of 300 cardiac catheterization procedures, of which at least 75 should be percutaneous coronary intervention (PCI) or as dictated by American College of Cardiology (ACC)/American Heart Association (AHA) Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories effective 1991;

4. Use only AHA/ACC-qualified operators who meet the standards for training and competency;

5. Demonstrate appropriate planning for program development and complete both a primary PCI development program and an elective PCI development program that includes routine care process and case selection review;

6. Develop and maintain a quality and error management program;

7. Provide PCI 24 hours a day, seven days a week;

8. Develop and maintain necessary agreements with a tertiary facility that must agree to accept emergent and nonemergent transfers for additional medical care, cardiac surgery, or intervention; and

9. Develop and maintain agreements with an ambulance service capable of advanced life support and intra-aortic balloon pump transfer that guarantees a 30-minute or less response time.

B. Complex therapeutic cardiac catheterization. Proposals to provide complex therapeutic cardiac catheterization should be approved only when open heart surgery services are available on-site in the same hospital in which the proposed complex therapeutic service will be located. Additionally, these complex therapeutic cardiac catheterization programs will be required to participate in the Virginia Cardiac Services Quality Initiative and the Virginia Heart Attack Coalition.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009; amended, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC5-230-430 Staffing

A. Cardiac catheterization services should have a medical director who is board certified in cardiology and has clinical experience in performing physiologic and angiographic procedures.

In the case of pediatric cardiac catheterization services, the medical director should be board-certified in pediatric cardiology and have clinical experience in performing physiologic and angiographic procedures.

B. Cardiac catheterization services should be under the direct supervision or one or more qualified physicians. Such physicians should have clinical experience in performing physiologic and angiographic procedures.

Pediatric catheterization services should be under the direct supervision of one or more qualified physicians. Such physicians should have clinical experience in performing pediatric physiologic and angiographic procedures.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 2 Criteria and Standards for Open Heart Surgery

12VAC5-230-440 Travel time

Article 2 Criteria and Standards for Open Heart Surgery

A. Open heart surgery services should be within 60 minutes driving time one way under normal conditions of 95% of the population of the health planning district using mapping software as determined by the commissioner.

B. Such services shall be available 24 hours a day, seven days a week.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-450 Need for new service

A. No new open heart services should be approved unless:

1. The service will be available in an inpatient hospital with an established cardiac catheterization service that has performed an average of 1,200 DEPs for the relevant reporting period and has been in operation for at least 30 months;

2. Open heart surgery services located in the health planning district performed an average of 400 open heart and closed heart surgical procedures for the relevant reporting period; and

3. The proposed new service will perform at least 150 procedures per room in the first year of operation and 250 procedures per room in the second year of operation without significantly reducing the utilization of existing open heart surgery services in the health planning district.

B. Preference may be given to a project that locates new open heart surgery services at an inpatient hospital more than 60 minutes driving time one way under normal condition from any site in which open heart surgery services are currently available and:

1. The proposed new service will perform an average of 150 open heart procedures in the first year of operation and 200 procedures in the second year of operation without significantly reducing the utilization of existing open heart surgery rooms within two hours driving time one way under normal conditions from the proposed new service location below 400 procedures per room; and

2. The hospital provided an average of 1,200 cardiac catheterization DEPs during the relevant reporting period in a service that has been in operation at least 30 months.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-460 Expansion of service

Proposals to expand open heart surgery services shall demonstrate that existing open heart surgery rooms operated by the applicant have performed an average of:

1. 400 adult equivalent open heart surgery procedures in the relevant reporting period if the proposed increase is within one hour driving time one way under normal conditions of an existing open heart surgery service; or

2. 300 adult equivalent open heart surgery procedures in the relevant reporting period if the proposed service is in excess of one hour driving time one way under normal conditions of an existing open heart surgery service in the health planning district.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-470 Pediatric open heart surgery services

No new pediatric open heart surgery service should be approved unless the proposed new service is provided at an inpatient hospital that:

1. Has pediatric cardiac catheterization services that have been in operation for 30 months and have performed an average of 200 pediatric cardiac catheterization procedures for the relevant reporting period; and

2. Has pediatric intensive care services and provides specialty or subspecialty neonatal special care.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-480 Staffing

A. Open heart surgery services should have a medical director who is board certified in cardiovascular or cardiothoracic surgery by the appropriate board of the American Board of Medical Specialists.

In the case of pediatric cardiac surgery, the medical director should be board certified in cardiovascular or cardiothoracic surgery, with special qualifications and experience in pediatric cardiac surgery and congenital heart disease, by the appropriate board of the American Board of Medical Specialists.

B. Cardiac surgery should be under the direct supervision of one or more qualified physicians.

Pediatric cardiac surgery services should be under the direct supervision of one or more qualified physicians.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part V General Surgical Services

12VAC5-230-490 Travel time

Surgical services should be available within 30 minutes driving time one way under normal conditions for 95% of the population of the health planning district using mapping software as determined by the commissioner.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-500 Need for new service

A. The combined number of inpatient and outpatient general purpose surgical operating rooms needed in a health planning district, exclusive of procedure rooms, dedicated cesarean section rooms, operating rooms designated exclusively for cardiac surgery, procedures rooms or VDH-designated trauma services, shall be determined as follows:

| | FOR = ((ORV/POP) x (PROPOP)) x AHORV | | --- | --- | | | 1600 |

Where:

ORV = the sum of total inpatient and outpatient general purpose operating room visits in the health planning district in the most recent five years for which general purpose operating room utilization data has been reported by VHI; and

POP = the sum of total population in the health planning district as reported by a demographic entity as determined by the commissioner, for the same five-year period as used in determining ORV.

PROPOP = the projected population of the health planning district five years from the current year as reported by a demographic program as determined by the commissioner.

AHORV = the average hours per general purpose operating room visit in the health planning district for the most recent year for which average hours per general purpose operating room visits have been calculated as reported by VHI.

FOR = future general purpose operating rooms needed in the health planning district five years from the current year.

1600 = available service hours per operating room per year based on 80% utilization of an operating room available 40 hours per week, 50 weeks per year.

B. Projects involving the relocation of existing operating rooms within a health planning district may be authorized when it can be reasonably documented that such relocation will: (i) improve the distribution of surgical services within a health planning district ; (ii) result in the provision of the same surgical services at a lower cost to surgical patients in the health planning district; or (iii) optimize the number of operations in the health planning district that are performed on an outpatient basis.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-510 Staffing

Surgical services should be under the direction or supervision of one or more qualified physicians.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part VI Inpatient Bed Requirements

12VAC5-230-520 Travel time

Inpatient beds should be within 30 minutes driving time one way under normal conditions of 95% of the population of a health planning district using a mapping software as determined by the commissioner.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-530 Need for new service

A. No new inpatient beds should be approved in any health planning district unless:

1. The resulting number of beds for each bed category contained in this article does not exceed the number of beds projected to be needed for that health planning district for the fifth planning horizon year; and

2. The average annual occupancy based on the number of beds in the health planning district for the relevant reporting period is:

a. 80% at midnight census for medical/surgical or pediatric beds;

b. 65% at midnight census for intensive care beds.

B. For proposals to convert under-utilized beds that require a capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection C of this section, consideration may be given to such proposal if:

1. There is a projected need in the applicable category of inpatient beds; and

2. The applicant can demonstrate that the average annual occupancy of the converted beds would meet the utilization standard for the applicable bed category by the first year of operation.

For the purposes of this part, "underutilized" means less than 80% average annual occupancy for medical/surgical or pediatric beds, when the relocation involves such beds and less than 65% average annual occupancy for intensive care beds when relocation involves such beds.

C. The capital expenditure threshold referenced in subsection B of this section shall be adjusted annually using the percentage increase listed in the Consumer Price Index for All Urban Consumers (CPI-U) for the most recent year as follows:

A x (1+B)

where:

A = the capital expenditure threshold amount for the previous year

and

B = the percent increase for the expense category "Medical Care" listed in the most recent year available of the CPI-U of the U.S. Bureau of Labor Statistics.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009; amended, Virginia Register Volume 30, Issue 8, eff. February 4, 2014.

12VAC5-230-540 Need for medical/surgical beds

The number of medical/surgical beds projected to be needed in a health planning district shall be computed as follows:

1. Determine the use rate for the medical/surgical beds for the health planning district using the formula:

BUR = (IPD/PoP)

Where:

BUR = the bed use rate for the health planning district.

IPD = the sum of total inpatient days in the health planning district for the most recent five years for which inpatient day data has been reported by VHI; and

PoP = the sum of total population 18 years of age and older in the health planning district for the same five years used to determine IPD as reported by a demographic program as determined by the commissioner.

2. Determine the total number of medical/surgical beds needed for the health planning district in five years from the current year using the formula:

ProBed = ((BUR x ProPop)/365)/0.80

Where:

ProBed = The projected number of medical/surgical beds needed in the health planning district for five years from the current year.

BUR = the bed use rate for the health planning district determined in subdivision 1 of this section.

ProPop = the projected population 18 years of age and older of the health planning district five years from the current year as reported by a demographic program as determined by the commissioner.

3. Determine the number of medical/surgical beds that are needed in the health planning district for the five planning horizon years as follows:

NewBed = ProBed – CurrentBed

Where:

NewBed = the number of new medical/surgical beds that can be established in a health planning district, if the number is positive. If NewBed is a negative number, no additional medical/surgical beds should be authorized for the health planning district.

ProBed = the projected number of medical/surgical beds needed in the health planning district for five years from the current year determined in subdivision 2 of this section.

CurrentBed = the current inventory of licensed and authorized medical/surgical beds in the health planning district.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009; amended, Virginia Register Volume 25, Issue 13, eff. April 1, 2009.

12VAC5-230-550 Need for pediatric beds

The number of pediatric beds projected to be needed in a health planning district shall be computed as follows:

1. Determine the use rate for pediatric beds for the health planning district using the formula:

PBUR = (PIPD/PedPop)

Where:

PBUR = The pediatric bed use rate for the health planning district.

PIPD = The sum of total pediatric inpatient days in the health planning district for the most recent five years for which inpatient days data has been reported by VHI; and

PedPop = The sum of population under 18 years of age in the health planning district for the same five years used to determine PIPD as reported by a demographic program as determined by the commissioner.

2. Determine the total number of pediatric beds needed to the health planning district in five years from the current year using the formula:

ProPedBed = ((PBUR x ProPedPop)/365)/0.80

Where:

ProPedBed = The projected number of pediatric beds needed in the health planning district for five years from the current year.

PBUR = The pediatric bed use rate for the health planning district determined in subdivision 1 of this section.

ProPedPop = The projected population under 18 years of age of the health planning district five years from the current year as reported by a demographic program as determined by the commissioner.

3. Determine the number of pediatric beds needed within thehealth planning district for the fifth planning horizon year as follows:

NewPedBed – ProPedBed – CurrentPedBed

Where:

NewPedBed = the number of new pediatric beds that can be established in a health planning district, if the number is positive. If NewPedBed is a negative number, no additional pediatric beds should be authorized for the health planning district.

ProPedBed = the projected number of pediatric beds needed in the health planning district for five years from the current year determined in subdivision 2 of this section.

CurrentPedBed = the current inventory of licensed and authorized pediatric beds in the health planning district.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009; amended, Virginia Register Volume 25, Issue 13, eff. April 1, 2009.

12VAC5-230-560 Need for intensive care beds

The projected need for intensive care beds in a health planning district shall be computed as follows:

1. Determine the use rate for ICU beds for the health planning district using the formula:

ICUBUR = (ICUPD/Pop)

Where:

ICUBUR = The ICU bed use rate for the health planning district.

ICUPD = The sum of total ICU inpatient days in the health planning district for the most recent five years for which inpatient day data has been reported by VHI; and

Pop = The sum of population 18 years of age or older for adults or under 18 for pediatric patients in the health planning district for the same five years used to determine ICUPD as reported by a demographic program as determined by the commissioner.

2. Determine the total number of ICU beds needed for the health planning district, including bed availability for unscheduled admissions, five years from the current year using the formula:

ProICUBed = ((ICUBUR x ProPop)/365)/0.65

Where:

ProICUBed = The projected number of ICU beds needed in the health planning district for five years from the current year;

ICUBUR = The ICU bed use rate for the health planning district as determine in subdivision 1 of this section;

ProPop = The projected population 18 years of age or older for adults or under 18 for pediatric patients of the health planning district five years from the current year as reported by a demographic program as determined by the commissioner.

3. Determine the number of ICU beds that may be established or relocated within the health planning district for the fifth planning horizon planning year as follows:

NewICUB = ProICUBed – CurrentICUBed

Where:

NewICUBed = The number of new ICU beds that can be established in a health planning district, if the number is positive. If NewICUBed is a negative number, no additional ICU beds should be authorized for the health planning district.

ProICUBed = The projected number of ICU beds needed in the health planning district for five years from the current year as determined in subdivision 2 of this section.

CurrentICUBed = The current inventory of licensed and authorized ICU beds in the health planning district.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009; amended, Virginia Register Volume 25, Issue 13, eff. April 1, 2009.

12VAC5-230-570 Expansion or relocation of services

A. Proposals to relocate beds to a location not contiguous to the existing site should be approved only when:

1. Off-site replacement is necessary to correct life safety or building code deficiencies;

2. The population currently served by the beds to be moved will have reasonable access to the beds at the new site, or to neighboring inpatient facilities;

3. The number of beds to be moved off-site is taken out of service at the existing facility;

4. The off-site replacement of beds results in:

a. A decrease in the licensed bed capacity;

b. A substantial cost savings, cost avoidance, or consolidation of underutilized facilities; or

c. Generally improved operating efficiency in the applicant's facility or facilities; and

5. The relocation results in improved distribution of existing resources to meet community needs.

B. Proposals to relocate beds within a health planning district where underutilized beds are within 30 minutes driving time one way under normal conditions of the site of the proposed relocation should be approved only when the applicant can demonstrate that the proposed relocation will not materially harm existing providers.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-580 Long-term acute care hospitals (LTACHs)

A. LTACHs will not be considered as a separate category for planning or licensing purposes. All LTACH beds remain part of the inventory of inpatient hospital beds.

B. A LTACH shall only be approved if an existing hospital converts existing medical/surgical beds to LTACH beds or if there is an identified need for LTACH beds within a health planning district. New LTACH beds that would result in an increase in total licensed beds above 165% of the average daily census for the health planning district will not be approved. Excess inpatient beds within an applicant's existing acute care facilities must be converted to fill any unmet need for additional LTACH beds.

C. If an existing or host hospital converts existing beds for use as LTACH beds, those beds must be delicensed from the bed inventory of the existing hospital. If the LTACH ceases to exist, terminates its services, or does not offer services for a period of 12 months within its first year of operation, the beds delicensed by the host hospital to establish the LTACH shall revert back to that host hospital.

If the LTACH ceases operation in subsequent years of operation, the host hospital may reacquire the LTACH beds by obtaining a COPN, provided the beds are to be used exclusively for their original intended purpose and the application meets all other applicable project delivery requirements. Such an application shall not be subject to the standard batch review cycle and shall be processed as allowed under Part VI (12VAC5-220-280 et seq.) of the Virginia Medical Care Facilities Certificate of Public Need Rules and Regulations.

D. The application shall delineate the service area for the LTACH by documenting the expected areas from which it is expected to draw patients.

E. A LTACH shall be established for 10 or more beds.

F. A LTACH shall become certified by the Centers for Medicare and Medicaid Services (CMS) as a long-term acute care hospital and shall not convert to a hospital for patients needing a length of stay of less than 25 days without obtaining a certificate of public need.

1. If the LTACH fails to meet the CMS requirements as a LTACH within 12 months after beginning operation, it may apply for a six-month extension of its COPN.

2. If the LTACH fails to meet the CMS requirements as a LTACH within the extension period, then the COPN granted pursuant to this section shall expire automatically.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-590 Staffing

Inpatient services should be under the direction or supervision of one or more qualified physicians.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part VII Nursing Facilities

12VAC5-230-600 Travel time

A. Nursing facility beds should be accessible within 30 minutes driving time one way under normal conditions to 95% of the population in a health planning district using mapping software as determined by the commissioner.

B. Nursing facilities should be accessible by public transportation when such systems exist in an area.

C. Preference may be given to proposals that improve geographic access and reduce travel time to nursing facilities within a health planning district.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-610 Need for new service

A. A health planning district should be considered to have a need for additional nursing facility beds when:

1. The bed need forecast exceeds the current inventory of existing and authorized beds for the health planning district; and

2. The median annual occupancy of all existing and authorized Medicaid-certified nursing facility beds in the health planning district was at least 93%, and the average annual occupancy of all existing and authorized Medicaid-certified nursing facility beds in the health planning district was at least 90%, excluding the bed inventory and utilization of the Virginia Veterans Care Centers.

Exception: When there are facilities that have been in operation less than one year in the health planning district, their occupancy can be excluded from the calculation of average occupancy .

B. No health planning district should be considered in need of additional beds if there are unconstructed beds designated as Medicaid certified. This presumption of "no need" for additional beds extends for three years from the issuance date of the certificate.

C. The bed need forecast will be computed as follows:

PDBN = (UR64 x PP64) + (UR69 x PP69) + (UR74 x PP74) + (UR79 x PP79) + (UR84 x PP84) + (UR85 x PP85)

Where:

PDBN = Planning district bed need.

UR64 = The nursing home bed use rate of the population aged 0 to 64 in the health planning district as determined in the most recent nursing home patient origin study authorized by VHI.

PP64 = The population aged 0 to 64 projected for thehealth planning district three years from the current year as most recently published by a demographic program as determined by the commissioner.

UR69 = The nursing home bed use rate of the population aged 65 to 69 in the health planning district as determined in the most recent nursing home patient origin study authorized by VHI.

PP69 = The population aged 65 to 69 projected for the health planning district three years from the current year as most recently published by a demographic program as determined by the commissioner.

UR74 = The nursing home bed use rate of the population aged 70 to 74 in the health planning district as determined in the most recent nursing home patient origin study authorized by VHI.

PP74 = The population aged 70 to 74 projected for the health planning district three years from the current year as most recently published by a demographic program as determined by the commissioner.

UR79 = The nursing home bed use rate of the population aged 75 to 79 in the health planning district as determined in the most recent nursing home patient origin study authorized by VHI.

PP79 = The population aged 75 to 79 projected for the health planning district three years from the current year as most recently published by a demographic program as determined by the commissioner.

UR84 = The nursing home bed use rate of the population aged 80 to 84 in the health planning district as determined in the most recent nursing home patient origin study authorized by VHI.

PP84 = The population aged 80 to 84 projected for the health planning district three years from the current year as most recently published by a demographic program as determined by the commissioner.

UR85+ = The nursing home bed use rate of the population aged 85 and older in the health planning district as determined in the most recent nursing home patient origin study authorized by VHI.

PP85+ = The population aged 85 and older projected for the health planning district three years from the current year as most recently published by a demographic program as determined by the commissioner.

Health planning district bed need forecasts will be rounded as follows:

| Health Planning District Bed Need | Rounded Bed Need | | --- | --- | | 1–29 | 0 | | 30–44 | 30 | | 45–84 | 60 | | 85–104 | 90 | | 105–134 | 120 | | 135–164 | 150 | | 165–194 | 180 | | 195–224 | 210 | | 225+ | 240 |

Exception: When a health planning district has:

1. Two or more nursing facilities;

2. Had a median annual occupancy rate of 93% of all existing and authorized Medicaid-certified nursing facility beds and an annual average occupancy rate of at least 90% of all existing and authorized Medicaid-certified nursing facility beds for each of the most recent two years for which bed utilization has been reported to VHI; and

3. Has a forecasted bed need of 15 to 29 beds, then the bed need for this health planning district will be rounded to 30.

D. No new freestanding nursing facilities of less than 90 beds should be authorized. However, consideration may be given to a new freestanding facility with fewer than 90 nursing facility beds when the applicant can demonstrate that such a facility is justified based on a locality's preference for such smaller facility and there is a documented poor distribution of nursing facility beds within the health planning district.

E. When evaluating the capital cost of a project, consideration may be given to projects that use the current methodology as determined by the Department of Medical Assistance Services.

F. Preference may be given to projects that replace outdated and functionally obsolete facilities with modern facilities that result in the more cost-efficient resident services in a more aesthetically pleasing and comfortable environment.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009; amended, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC5-230-620 Expansion of services

Proposals to increase an existing nursing facility's bed capacity should not be approved unless the facility has operated for at least two years and the average annual occupancy of the facility's existing beds was at least 90% in the relevant reporting period as reported to VHI.

Note: Exceptions will be considered for facilities that operated at less than 90% average annual occupancy in the most recent year for which bed utilization has been reported when the facility offers short stay services causing an average annual occupancy lower than 90% for the facility.

History

• Statutory Authority: §§ 32.1-12 and 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009; amended, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC5-230-630 Continuing care retirement communities

Proposals for the development of new nursing facilities or the expansion of existing facilities by continuing care retirement communities (CCRC) will be considered when:

1. The facility is registered with the State Corporation Commission as a continuing care provider pursuant to Chapter 49 (§ 38.2-4900 et seq.) of Title 38.2 of the Code of Virginia;

2. The number of nursing facility beds requested in the initial application does not exceed the lesser of 20% of the continuing care retirement community's total number of beds that are not nursing home beds or 60 beds;

3. The number of new nursing facility beds requested in any subsequent application does not cause the continuing care retirement community's total number of nursing home beds to exceed 20% of its total number of beds that are not nursing facility beds; and

4. The continuing care retirement community has established a qualified resident assistance policy.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-640 Staffing

Nursing facilities shall be under the direction or supervision of a licensed nursing home administrator and staffed by licensed and certified nursing personnel qualified as required by law.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part VIII Lithotripsy Service

12VAC5-230-650 Travel time

Lithotripsy services should be available within 30 minutes driving time one way under normal conditions for 95% of the population of the health planning region using mapping software as determined by the commissioner.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-660 Need for new service

A. Preference may be given to a project that establishes new renal or orthopedic lithotripsy services at a new facility through contract with, or by lease of equipment from, an existing service provider authorized to operate in Virginia, and the facility has referred at least two appropriate patients per week, or 100 appropriate patients annually, for the relevant reporting period to other facilities for either renal or orthopedic lithotripsy services.

B. A new renal lithotripsy service may be approved if the applicant can demonstrate that the proposed service can provide at least 750 renal lithotripsy procedures annually.

C. A new orthopedic lithotripsy service may be approved if the applicant can demonstrate that the proposed service can provide at least 500 orthopedic lithotripsy procedures annually.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-670 Expansion of services

A. Proposals to expand renal lithotripsy services should demonstrate that each existing unit owned or operated by that vendor or provider has provided at least 750 procedures annually at all sites served by the vendor or provider.

B. Proposals to expand orthopedic lithotripsy services should demonstrate that each existing unit owned or operated by that vendor or provider has provided at least 500 procedures annually at all sites served by the vendor or provider.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-680 Adding or expanding mobile lithotripsy services

A. Proposals for mobile lithotripsy services should demonstrate that, for the relevant reporting period, at least 125 procedures were performed and that the proposed mobile unit will not reduce the utilization of existing machines in the health planning region.

B. Proposals to convert a mobile lithotripsy service to a fixed site lithotripsy service should demonstrate that, for the relevant reporting period, at least 430 procedures were performed and the proposed conversion will not reduce the utilization of existing providers in the health planning district.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-690 Staffing

Lithotripsy services should be under the direction or supervision of one or more qualified physicians.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part IX Organ Transplant

12VAC5-230-700 Travel time

A. Organ transplantation services should be accessible within two hours driving time one way under normal conditions of 95% of Virginia's population using mapping software as determined by the commissioner.

B. Providers of organ transplantation services should facilitate access to pre and post transplantation services needed by patients residing in rural locations be establishing part-time satellite clinics.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-710 Need for new service

A. There should be no more than one program for each transplantable organ in a health planning region.

B. Performance of minimum transplantation volumes as cited in 12VAC5-230-720 does not indicate a need for additional transplantation capacity or programs.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-720 Transplant volumes; survival rates; service proficiency; systems operations

A. Proposals to establish organ transplantation services should demonstrate that the minimum number of transplants would be performed annually. The minimum number transplants of required by organ system is:

| | Kidney | 30 | | --- | --- | --- | | | Pancreas or kidney/pancreas | 12 | | | Heart | 17 | | | Heart/Lung | 12 | | | Lung | 12 | | | Liver | 21 | | | Intestine | 2 |

Note: Any proposed pancreas transplant program must be a part of a kidney transplant program that has achieved a minimum volume standard of 30 cases per year for kidney transplants as well as the minimum transplant survival rates stated in subsection B of this section.

B. Applicants shall demonstrate that they will achieve and maintain at least the minimum transplant patient survival rates. Minimum one-year survival rates listed by organ system are:

| | Kidney | 95% | | --- | --- | --- | | | Pancreas or kidney/pancreas | 90% | | | Heart | 85% | | | Heart/Lung | 70% | | | Lung | 77% | | | Liver | 86% | | | Intestine | 77% |

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-730 Expansion of transplant services

A. Proposals to expand organ transplantation services shall demonstrate at least two years successful experience with all existing organ transplantation systems at the hospital.

B. Preference may be given to a project expanding the number of organ systems being transplanted at a successful existing service rather than developing new programs that could reduce existing program volumes.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-740 Staffing

Organ transplant services should be under the direct supervision of one or more qualified physicians.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part X Miscellaneous Capital Expenditures

12VAC5-230-750 Purpose

This part of the SMFP is intended to provide general guidance in the review of projects that require COPN authorization by virtue of their expense but do not involve changes in the bed or service capacity of a medical care facility addressed elsewhere in this chapter. This part may be used in coordination with other service specific parts addressed elsewhere in this chapter.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-760 Project need

12VAC5-230-760. Project need.

A. All applications involving a capital expenditure with an expenditure exceeding the threshold amount as determined using the formula contained in subsection B of this section by a medical care facility should include documentation that the expenditure is necessary in order for the facility to meet the identified medical care needs of the public it serves. Such documentation should clearly identify that the expenditure:

1. Represents the most cost-effective approach to meeting the identified need; and

2. The ongoing operational costs will not result in unreasonable increases in the cost of delivering the services provided.

B. The capital expenditure threshold referenced in subsection A of this section shall be adjusted annually using the percentage increase listed in the Consumer Price Index for All Urban Consumers (CPI-U) for the most recent year as follows:

A x (1+B)

where:

A = the capital expenditure threshold amount for the previous year

and

B = the percent increase for the expense category "Medical Care" listed in the most recent year available of the CPI-U of the U.S. Bureau of Labor Statistics.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009; amended, Virginia Register Volume 30, Issue 8, eff. February 4, 2014.

12VAC5-230-770 Facilities expansion

Applications for the expansion of medical care facilities should document that the current space provided in the facility for the areas or departments proposed for expansion is inadequate. Such documentation should include:

1. An analysis of the historical volume of work activity or other activity performed in the area or department;

2. The projected volume of work activity or other activity to be performed in the area or department; and

3. Evidence that contemporary design guidelines for space in the relevant areas or departments, based on levels of work activity or other activity, are consistent with the proposal.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-780 Renovation or modernization

A. Applications for the renovation or modernization of medical care facilities should provide documentation that:

1. The timing of the renovation or modernization expenditure is appropriate within the life cycle of the affected building or buildings; and

2. The benefits of the proposed renovation or modernization will exceed the costs of the renovation or modernization over the life cycle of the affected building or buildings to be renovated or modernized.

B. Such documentation should include a history of the affected building or buildings, including a chronology of major renovation and modernization expenses.

C. Applications for the general renovation or modernization of medical care facilities should include downsizing of beds or other service capacity when such capacity has not operated at a reasonable level of efficiency as identified in the relevant sections of this chapter during the most recent five-year period.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-790 Equipment

Applications for the purchase and installation of equipment by medical care facilities that are not addressed elsewhere in this chapter should document that the equipment is needed. Such documentation should clearly indicate that the (i) proposed equipment is needed to maintain the current level of service provided, or (ii) benefits of the change in service resulting from the new equipment exceed the costs of purchasing or leasing and operating the equipment over its useful life.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Part XI Medical Rehabilitation

12VAC5-230-800 Travel time

Medical rehabilitation services should be available within 60 minutes driving time one way under normal conditions of 95% of the population of the health planning district using mapping software as determined by the commissioner.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-810 Need for new service

A. The number of comprehensive and specialized rehabilitation beds shall be determined as follows:

((UR x PROPOP)/365)/.80

Where:

UR = the use rate expressed as rehabilitation patient days per population in the health planning district as reported by VHI; and

PROPOP = the most recent projected population of the health planning district five years from the current year as published by a demographic entity as determined by the commissioner.

B. Proposals for new medical rehabilitation beds should be considered when the applicant can demonstrate that:

1. The rehabilitation specialty proposed is not currently offered in the health planning district; and

2. There is a documented need for the service or beds in the health planning district.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-820 Expansion of services

No additional rehabilitation beds should be authorized for a health planning district in which existing rehabilitation beds were utilized with an average annual occupancy of less than 80% in the most recently reported year.

Preference may be given to a project to expand rehabilitation beds by converting underutilized medical/surgical beds.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-830 Staffing

Medical rehabilitation facilities should be under the direction or supervision of one or more qualified physicians.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 1 Acute Psychiatric and Acute Substance Abuse Disorder Treatment Services

12VAC5-230-840 Travel time

Article 1 Acute Psychiatric and Acute Substance Abuse Disorder Treatment Services

Acute psychiatric and acute substance abuse disorder treatment services should be available within 60 minutes driving time one way under normal conditions of 95% of the population using mapping software as determined by the commissioner.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-850 Continuity; integration

A. Existing and proposed acute psychiatric and acute substance abuse disorder treatment providers shall have established plans for the provision of services to indigent patients that include:

1. The minimum number of unreimbursed patient days to be provided to indigent patients who are not Medicaid recipients;

2. The minimum number of Medicaid-reimbursed patient days to be provided, unless the existing or proposed facility is ineligible for Medicaid participation;

3. The minimum number of unreimbursed patient days to be provided to local community services boards; and

4. A description of the methods to be utilized in implementing the indigent patient service plan and assuring the provision of the projected levels of unreimbursed and Medicaid-reimbursed patient days.

B. Proposed acute psychiatric and acute substance abuse disorder treatment providers shall have formal agreements with the appropriate local community services boards or behavioral health authority that:

1. Specify the number of patient days that will be provided to the community service board;

2. Describe the mechanisms to monitor compliance with charity care provisions;

3. Provide for effective discharge planning for all patients, including return to the patient's place of origin or home state if not Virginia; and

4. Consider admission priorities based on relative medical necessity.

C. Providers of acute psychiatric and acute substance abuse disorder treatment serving large geographic areas should establish satellite outpatient facilities to improve patient access where appropriate and feasible.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-860 Need for new service

A. The combined number of acute psychiatric and acute substance abuse disorder treatment beds needed in a health planning district with existing acute psychiatric or acute substance abuse disorder treatment beds or both will be determined as follows:

((UR x PROPOP)/365)/.75

Where:

UR = the use rate of the health planning district expressed as the average acute psychiatric and acute substance abuse disorder treatment patient days per population reported for the most recent five-year period; and

PROPOP = the projected population of the health planning district five years from the current year as reported in the most recent published projections by a demographic entity as determined by the Commissioner of the Department of Mental Health, Mental Retardation and Substance Abuse Services.

For purposes of this methodology, no beds shall be included in the inventory of psychiatric or substance abuse disorder beds when these beds (i) are in facilities operated by the Department of Mental Health, Mental Retardation and Substance Abuse Services; (ii) have been converted to other uses; (iii) have been vacant for six months or more; or (iv) are not currently staffed and cannot be staffed for acute psychiatric or substance abuse disorder patient admissions within 24 hours.

B. Subject to the provisions of 12VAC5-230-70,no additional acute psychiatric or acute substance abuse disorder treatment beds should be authorized for a health planning district with existing acute psychiatric or acute substance abuse disorder treatment beds or both if the existing inventory of such beds is greater than the need identified using the above methodology.

Preference may also be given to the addition of acute psychiatric or acute substance abuse beds dedicated for the treatment of geriatric patients in health planning districts with an excess supply of beds when such additions are justified on the basis of the specialized treatment needs of geriatric patients.

C. No existing acute psychiatric or acute substance disorder abuse treatment beds should be relocated unless it can be reasonably projected that the relocation will not have a negative impact on the ability of existing acute psychiatric or substance abuse disorder treatment providers or both to continue to provide historic levels of service to Medicaid or other indigent patients.

D. The combined number of acute psychiatric and acute substance abuse disorder treatment beds needed in a health planning district without existing acute psychiatric or acute substance abuse disorder treatment beds will be determined as follows:

((UR x PROPOP)/365)/.75

Where:

UR = the use rate of the health planning region in which the health planning district is located expressed as the average acute psychiatric and acute substance abuse disorder treatment patient days per population reported for the most recent five-year period;

PROPOP = the projected population of the health planning district five years from the current year as reported in the most recent published projections by a demographic entity as determined by the Commissioner of the Department of Mental Health, Mental Retardation and Substance Abuse Services.

E. Preference may be given to the development of needed acute psychiatric beds through the conversion of unused general hospital beds. Preference will also be given to proposals for acute psychiatric and substance abuse beds demonstrating a willingness to accept persons under temporary detention orders (TDO) and that have contractual agreements to serve populations served by community services boards, whether through conversion of underutilized general hospital beds or development of new beds.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 2 Mental Retardation

12VAC5-230-870 Need for new service

Article 2 Mental Retardation

The establishment of new ICF/MR facilities with more than 12 beds shall not be authorized unless the following conditions are met:

1. Alternatives to the proposed service are not available in the area to be served by the new facility;

2. There is a documented source of referrals for the proposed new facility;

3. The manner in which the proposed new facility fits into the continuum of care for the mentally retarded is identified;

4. There are distinct and unique geographic, socioeconomic, cultural, transportation, or other factors affecting access to care that require development of a new ICF/MR;

5. Alternatives to the development of a new ICF/MR consistent with the Medicaid waiver program have been considered and can be reasonably discounted in evaluating the need for the new facility;

6. The proposed new facility will have a maximum of 20 beds and is consistent with any plan of the Department of Mental Health, Mental Retardation and Substance Abuse Services and the mental retardation service priorities for the catchment area identified in the plan;

7. Ancillary and supportive services needed for the new facility are available; and

8. Service alternatives for residents of the proposed new facility who are ready for discharge from the ICF/MR setting are available.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009; Errata, 25:11 VA.R. 2018 February 2, 2009.

12VAC5-230-880 Continuity; integration

Each facility should have a written transfer agreement with one or more hospitals for the transfer of emergency cases if such hospitalization becomes necessary.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-890 Compliance with licensure standards

Mental retardation facilities should meet all applicable licensure standards as specified in 12VAC35-105, Rules and Regulations for the Licensing of Providers of Mental Health, Mental Retardation and Substance Abuse Services.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 1 Criteria and Standards for Obstetrical Services

12VAC5-230-900 Travel time

Article 1 Criteria and Standards for Obstetrical Services

Obstetrical services should be located within 30 minutes driving time one way under normal conditions of 95% of the population of the health planning district using mapping software as determined by the commissioner.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-910 Need for new service

No new obstetrical services should be approved unless the applicant can demonstrate that, based on the population and utilization of current services, there is a need for such services in the health planning district without significantly reducing the utilization of existing providers in the health planning district.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-920 Continuity

A. Perinatal service capacity, including service availability for unscheduled admissions, should be developed to provide routine newborn care to infants delivered in the associated obstetrics service, and shall be able to stabilize and prepare for transport those infants requiring the care of a neonatal special care services unit.

B. The proposal shall identify the primary and secondary neonatal special care center nearest the proposed service shall provide transport one-way to those centers.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-930 Staffing

Obstetric services should be under the direction or supervision of one or more qualified physicians.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 2 Neonatal Special Care Services

12VAC5-230-940 Travel time

Article 2 Neonatal Special Care Services

A. Intermediate level neonatal special care services should be located within 30 minutes driving time one way under normal conditions of hospitals providing general level new born services using mapping software as determined by the commissioner.

B. Specialty and subspecialty neonatal special care services should be located within 90 minutes driving time one way under normal conditions of hospitals providing general or intermediate level newborn services using mapping software as determined by the commissioner.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-950 Need for new service

No new level of neonatal service shall be offered by a hospital unless that hospital has first obtained a COPN granting approval to provide each such level of service.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-960 Intermediate level newborn services

A. Existing intermediate level newborn services as designated in 12VAC5-410-443 should achieve 85% average annual occupancy before new intermediate level newborn services can be added to the health planning region.

B. Intermediate level newborn services as designated in 12VAC5-410-443 should contain a minimum of six bassinets.

C. No more than four bassinets for intermediate level newborn services as designated in 12VAC5-410-443 per 1,000 live births should be established in each health planning region.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-970 Specialty level newborn services

A. Existing specialty level newborn services as designated in 12VAC5-410-443 should achieve 85% average annual occupancy before new specialty level newborn services can be added to the health planning region.

B. Specialty level newborn services as designated in 12VAC5-410-443 should contain a minimum of 18 bassinets .

C. No more than four bassinets for specialty level newborn services as designated in 12VAC5-410-443 per 1,000 live births should be established in each health planning region.

D. Proposals to establish specialty level services as designated in 12VAC5-410-443 shall demonstrate that service volumes of existing specialty level newborn service providers located within the travel time listed in 12VAC5-230-940 will not be significantly reduced.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-980 Subspecialty level newborn services

A. Existing subspecialty level newborn services as designated in 12VAC5-410-443 should achieve 85% average annual occupancy before new subspecialty level newborn services can be added to the health planning region.

B. Subspecialty level newborn services as designated in 12VAC5-410-443 should contain a minimum of 18 bassinets .

C. No more than four bassinets for subspecialty level newborn services as designated in 12VAC5-410-443 per 1,000 live births should be established in each health planning region.

D. Proposals to establish subspecialty level newborn services as designated in 12VAC5-410-443 shall demonstrate that service volumes of existing subspecialty level newborn providers located within the travel time listed in 12VAC5-230-940 will not be significantly reduced.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-990 Neonatal services

The application shall identify the service area and the levels of service of all the hospitals to be served by the proposed service.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-1000 Staffing

All levels of neonatal special care services should be under the direction or supervision of one or more qualified physicians as described in 12VAC5-410-443.

History

• Statutory Authority: § 32.1-102.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Chapter 371 Regulations for the Licensure of Nursing Facilities

Part I Definitions and General Information

12VAC5-371-10 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Abuse" means the willful infliction of injury, unreasonable confinement, intimidation, or punishment with resulting physical harm, pain or mental anguish, or deprivation by an individual, including caretaker, of goods or services that are necessary to attain or maintain physical, mental, and psychosocial well-being. This includes verbal, sexual, physical, or mental abuse.

"ACIP" means the Advisory Committee on Immunization Practices of the CDC.

"Administrator" means the individual licensed by the Board of Long-Term Care Administrators who has the necessary authority and responsibility for management of the nursing facility.

"Admission" means the process of acceptance into a nursing facility, including orientation, rules and requirements, and assignment to appropriate staff. Admission does not include readmission to the facility after a temporary absence.

"Advance directive" means (i) a witnessed written document, voluntarily executed by the declarant in accordance with the requirements of § 54.1-2983 of the Code of Virginia, or (ii) a witnessed oral statement, made by the declarant subsequent to the time the declarant is diagnosed as suffering from a terminal condition and in accordance with the provisions of § 54.1-2983 of the Code of Virginia.

"Assessment" means the process of evaluating a resident for the purpose of developing a profile on which to base services. Assessment includes information gathering, both initially and on an ongoing basis, designed to assist the multi-disciplinary staff in determining the resident's need for care, and the collection and review of resident-specific data.

"Attending physician" means a physician currently licensed by the Board of Medicine and identified by the resident, or legal representative, as having the primary responsibility in determining the delivery of the resident's medical care.

"Barrier crime" means any offense set forth in clause (i) of the definition of barrier crime in § 19.2-392.02 of the Code of Virginia.

"Board" means the State Board of Health.

"Business day" means any day that is not a Saturday, Sunday, legal holiday, or day on which the OLC is closed. For the purposes of this chapter, any day on which the Governor authorizes the closing of the state government shall be considered a legal holiday.

"Cannabis oil" means the same as the term is defined in § 54.1-3408.3 A of the Code of Virginia.

"CDC" means the Centers for Disease Control and Prevention.

"Certified nurse aide" means the title that can only be used by individuals who have met the requirements to be certified, as defined by the Board of Nursing, and who are listed in the nurse aide registry.

"Chemical restraint" means a psychopharmacologic drug (a drug prescribed to control mood, mental status, or behavior) that is used for discipline or convenience and not required to treat medical symptoms or symptoms from mental illness or intellectual disability that prohibit an individual from reaching his highest level of functioning.

"Clinical record" means the documentation of health care services, whether physical or mental, rendered by direct or indirect resident-provider interactions. An account compiled by physicians and other health care professionals of a variety of resident health information, such as assessments and care details, including testing results, medicines, and progress notes.

"CMS" means the Centers for Medicare and Medicaid Services.

"Commissioner" means the State Health Commissioner.

"Complaint" means any allegation received by the Virginia Department of Health other than an incident reported by the facility staff. Such allegations include abuse, neglect, exploitation, or violation of state or federal laws or regulations.

"Comprehensive plan of care" means a written action plan based on assessment data that identifies a resident's clinical and psychosocial needs, the interventions to meet those needs, and treatment goals that are measurable and that documents the resident's progress toward meeting the stated goals.

"Construction" means the building of a new nursing facility or the expansion, remodeling, or alteration of an existing nursing facility and includes the initial and subsequent equipping of the facility.

"Criminal record report" means either the criminal record clearance with respect to convictions for barrier crimes or the criminal history record from the Central Criminal Records Exchange of the Virginia Department of State Police.

"Department" means the Virginia Department of Health.

"Dignity" means staff, in their interactions with residents, carry out activities that assist a resident in maintaining and enhancing the resident's self-esteem and self-worth.

"Discharge" means the process by which the resident's services, delivered by the nursing facility, are terminated.

"Discharge summary" means the final written summary of the services delivered, goals achieved, and post-discharge plan or final disposition at the time of discharge from the nursing facility. The discharge summary becomes a part of the clinical record.

"Drug" means (i) articles or substances recognized in the official United States "Drug" Pharmacopoeia National Formulary or official Homeopathic Pharmacopoeia of the United States, or any supplement to any of them; (ii) articles or substances intended for the use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animal; (iii) articles or substances, other than food, intended to affect the structure or any function of the body of man or other animal; and (iv) articles or substances intended for use as a component of any article specified in clause (i), (ii), or (iii). This does not include devices or their components, parts, or accessories.

"Electronic monitoring" means the use of a surveillance device with a fixed position video camera or recording device, or a combination thereof, that is installed in a resident's room and broadcasts or records activities or sounds occurring within the confines of the room. Electronic monitoring does not include use of a device that enables audio communication into the resident's room from another source.

"Emergency preparedness plan" means a component of a nursing facility's safety management program designed to manage the consequences of natural disasters or other emergencies that disrupt the nursing facility's ability to provide care.

"Employee" means a person who performs a specific job function for financial remuneration on a full-time or part-time basis.

"Facility-managed" means an electronic monitoring system that is installed, controlled, and maintained by the nursing facility with the knowledge of the resident or legal representative in accordance with the facility's policies.

"Family member" means the resident's spouse, parent, stepparent, child, stepchild, brother, sister, half-brother, half-sister, grandparent, or grandchild.

"Full-time" means a minimum of 35 hours or more worked per week in the nursing facility.

"Inspector" means an individual employed by or contracted by the department and designated by the commissioner to conduct inspections, investigations, or evaluations.

"Intelligent personal assistant" means a combination of an electronic device and a specialized software application designed to assist users with basic tasks using a combination of natural language processing and artificial intelligence, including such combinations known as digital assistants or virtual assistants.

"Legal representative" means a person legally responsible for representing or standing in the place of the resident for the conduct of the resident's affairs. This may include a guardian, conservator, attorney-in-fact under durable power of attorney, trustee, or other person expressly named by a court of competent jurisdiction or the resident as the resident's agency in a legal document that specifies the scope of the representative's authority to act. A legal representative may only represent or stand in the place of a resident for the function for which the representative has legal authority to act.

"Licensee" means a person that has received and maintains an active license under the provisions of Article 1 (§ 32.1-123 et seq.) of Chapter 5 of Title 32.1 of the Code of Virginia and this chapter.

"Medication" means any substance, whether prescription or over-the-counter drug, that is taken orally or injected, inserted, topically applied, or otherwise administered.

"Neglect" means a failure to provide timely and consistent services, treatment, or care to a resident necessary to obtain or maintain the resident's health, safety, or comfort or a failure to provide timely and consistent goods and services necessary to avoid physical harm, mental anguish, or mental illness.

"Nursing facility" means any nursing home as defined in § 32.1-123 of the Code of Virginia.

"OLC" means the Office of Licensure and Certification of the Virginia Department of Health.

"Person" means any individual, corporation, partnership, association, trust, or other legal entity, whether governmental or private, owning, managing, or operating a nursing facility.

"Physical restraint" means any manual method or physical or mechanical device, material, or equipment attached or adjacent to the resident's body that the individual cannot remove easily that restricts freedom of movement or normal access to one's own body.

"Policy" means a written statement that describes the principles and guides and governs the activities, procedures, and operations of the nursing facility.

"Procedures" means a series of activities designed to implement program goals or policy, which may or may not be written, depending upon the specific requirements within this chapter. For inspection purposes, there must be evidence that procedures are actually implemented.

"Progress note" means a written statement signed and dated by the person delivering the care consisting of a pertinent, chronological report of the resident's care. A progress note is a component of the clinical record.

"Qualified" means meeting current legal requirements of licensure, registration, or certification in Virginia; having appropriate training and experience commensurate with assigned responsibilities; or, if referring to a professional, possessing an appropriate degree or having documented equivalent education, training, or experience.

"Quality assurance" means systematic activities performed to determine the extent to which clinical practice meets specified standards and values with regard to such things as appropriateness of service assignment and duration, appropriateness of facilities and resources utilized, adequacy, and clinical soundness of care given. Such activities should also ensure changes in practice that do not meet accepted standards. Examples of quality assurance activities include the establishment of facility-wide goals for resident care, the assessment of the procedures used to achieve the goals, and the proposal of solutions to problems in attaining those goals.

"Readmission" means a planned return to the nursing facility following a temporary absence for hospitalization, off-site visit or therapeutic leave, or a return stay or confinement following a formal discharge terminating a previous admission.

"Resident" means the primary service recipient admitted to the nursing facility, whether that person is referred to as a client, consumer, patient, or other term.

"Resident-managed" means an electronic monitoring system that is installed, controlled, and maintained by the resident with the knowledge of the nursing facility.

"Supervision" means the ongoing process of monitoring the skills, competencies, and performance of the individual supervised and providing regular, face-to-face guidance and instruction.

"Sworn disclosure" means a written statement or affirmation disclosing any criminal convictions or any pending criminal charges, whether within or outside the Commonwealth, by an applicant for compensated employment with a nursing facility.

"Volunteer" means a person who, without financial remuneration, provides services to the nursing facility.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; amended, Virginia Register Volume 23, Issue 10, eff. March 1, 2007; Volume 26, Issue 26, eff. September 30, 2010; Volume 35, Issue 5, eff. December 13, 2018; Volume 36, Issue 23, eff. August 6, 2020; Volume 37, Issue 17, eff. May 27, 2021; Volume 38, Issue 4, eff. November 11, 2021; Volume 42, Issue 5, eff. November 19, 2025; Volume 42, Issue 23, eff. August 13, 2026.

12VAC5-371-20 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; repealed, Virginia Register Volume 23, Issue 10, eff. March 1, 2007.

12VAC5-371-30 License

A. This chapter is not applicable to:

1. Those entities listed in § 32.1-124 of the Code of Virginia; or

2. Facilities established or operated for the practice of religious tenets pursuant to § 32.1-128 of the Code of Virginia, except that such facilities shall comply with the statutes and regulations on environmental protection and life safety.

B. A license to operate a nursing facility shall be issued to a person.

C. Each license shall expire at 11:59 p.m. on December 31 of the year issued. A nursing facility shall operate within the terms of its license, which include the:

1. Name of the nursing facility;

2. Name of the operator;

3. Physical location of the nursing facility;

4. Maximum number of beds allowed, except as provided in 12VAC5-371-40 G; and

5. Date the license expires.

D. A separate license shall be required for nursing facilities maintained on separate premises, even if the facilities are owned or operated under the same management.

E. Every nursing facility shall be designated by a permanent and unique name.

F. The number of resident beds allowed in a nursing facility shall be determined by the commissioner.

G. Long-term care nursing units located in and operated by hospitals shall be licensed under Regulations for the Licensure of Hospitals in Virginia (12VAC5-410). Approval for such units shall be included on the annual license issued to each hospital.

H. Any person establishing, conducting, maintaining, or operating a nursing facility without a license shall be guilty of a Class 6 felony.

I. The licensee shall at all times:

1. Maintain an active and accurate license; and

2. Post its current license in a place readily visible and accessible to the public at the nursing facility.

History

• Statutory Authority: §§ 32.1-12, 32.1-125, and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; amended, Virginia Register Volume 23, Issue 10, eff. March 1, 2007; Volume 35, Issue 24, eff. August 23, 2019; Volume 37, Issue 17, eff. May 27, 2021; Volume 42, Issue 23, eff. August 13, 2026; Errata, 42:24 VA.R. 2223 July 13, 2026.

12VAC5-371-40 Licensing process

A. Upon request, the OLC will provide consultation to any person seeking information about obtaining a license. The purpose of such consultation is to:

1. Explain the standards and the licensing process;

2. Provide assistance in locating other sources of information;

3. Review the potential applicant's proposed program plans, forms, and other documents, as they relate to standards; and

4. Alert the potential applicant regarding the need to meet other state and local ordinances, such as fire and building codes and environmental health standards, where applicable.

B. Licensees and applicants shall obtain licensure applications from the OLC.

C. The OLC shall consider the application complete when all requested information and the application fee is submitted with the form required. If the OLC finds the application incomplete, the applicant will be notified of receipt of the incomplete application.

D. The applicant shall complete and submit the initial application to the OLC at least 30 days prior to a planned opening date to allow the OLC time to act on the application. An application for a license may be withdrawn at any time.

E. A nursing facility may not be licensed without first complying with the requirements for a Certificate of Public Need as required by Article 1.1. (§ 32.1-102.1 et seq.) of Chapter 4 of Title 32.1 of the Code of Virginia.

1. Application for initial license of a nursing facility shall include a statement of any agreement made with the commissioner as a condition for Certificate of Public Need approval to provide a level of care at a reduced rate to indigents or accept patients requiring specialized care.

2. Any initial license issued to any nursing facility that made such agreement as a condition of its Certificate of Public Need approval shall not be renewed without demonstrating prior to or at the time of applying for renewal that it is substantially complying with its agreement.

F. The renewal of a nursing facility license shall be conditioned upon the up-to-date payment of any civil penalties owed as a result of willful refusal, failure, or neglect to honor certain conditions established in their award of a Certificate of Public Need pursuant to § 32.1-102.4 B of the Code of Virginia.

G. Nursing facilities shall be exempt, for a period of no more than 30 days, from the requirement to obtain a license to add temporary beds when the commissioner has determined that a natural or man-made disaster has caused the evacuation of a hospital or nursing home and that a public health emergency exists due to a shortage of hospital or nursing home beds.

H. The licensee shall submit the completed renewal application form along with any required attachments and the application fee by the date indicated in the cover letter.

I. It is the licensee's responsibility to complete and return the application to assure timely processing. Should a current license expire before a new license is issued, the current license shall remain in effect provided the complete and accurate application was filed on time.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; amended, Virginia Register Volume 18, Issue 10, eff. February 28, 2002; Volume 23, Issue 10, eff. March 1, 2007; Volume 35, Issue 24, eff. August 23, 2019; Volume 37, Issue 17, eff. May 27, 2021.

12VAC5-371-50 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; repealed, Virginia Register Volume 23, Issue 10, eff. March 1, 2007.

12VAC5-371-55 Plan of correction

A. Upon receipt of a written inspection report, the administrator or the administrator's designee shall prepare a written plan of correction addressing each licensing violation cited at the time of inspection.

B. The administrator or the administrator's designee shall submit to the OLC a written plan of correction no more than 15 business days after receipt of the inspection report. The plan of correction shall contain, for each licensing violation cited:

1. A description of the corrective action to be taken and the position title of the employees to implement the corrective action. If employees share the same position title, the administrator or the administrator's designee shall assign the employees a unique identifier to distinguish them;

2. The expected correction date, not to exceed 45 business days from the exit date of the inspection; and

3. A description of the measures implemented to prevent a recurrence of each licensing violation.

C. The administrator or the administrator's designee shall ensure that the person responsible for the validity of the plan of correction signs, dates, and indicates the person's title on the plan of correction.

D. The OLC shall notify the administrator or the administrator's designee if the OLC determines any item in the plan of correction is unacceptable.

E. The OLC may conduct an inspection to verify any portion of a plan of correction has been implemented.

F. The administrator or the administrator's designee shall ensure the plan of correction is implemented and monitored so that compliance is maintained.

G. The commissioner may deny licensure or renewal of licensure or revoke licensure if the administrator or the administrator's designee fails to submit an acceptable plan of correction or fails to implement an acceptable plan of correction.

H. The OLC shall consider the submission date of a plan of correction to be the date the plan of correction is postmarked or the date it is received, whichever is earlier.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 42, Issue 23, eff. August 13, 2026.

12VAC5-371-60 Inspection procedure

A. The OLC shall make periodic unannounced on-site inspections of the nursing facility as necessary but not less often than biennially. The OLC may make on-site inspections of applicants for licensure. Compliance with all standards shall be determined by the OLC.

B. The licensee or applicant shall:

1. Make available to the inspector any requested records;

2. Permit an inspector to enter upon and into the licensee's or applicant's property to inspect or investigate, as the inspector reasonably deems necessary, in order to determine the state of compliance with the provisions of this chapter and all laws administered by the board; and

3. Allow the inspector access to interview the agents, employees, independent contractors, residents, legal representatives, resident's family members, and any person under the licensee's or applicant's control, direction, or supervision.

C. After the on-site inspection, the inspector shall:

1. Discuss the findings of the inspection with the administrator or the administrator's designee; and

2. Provide a written inspection report to the administrator or the administrator's designee.

D. If the OLC cites one or more licensing violations in the written inspection report, the administrator or the administrator's designee shall submit a plan of correction in accordance with 12VAC5-371-55.

History

• Statutory Authority: §§ 32.1-12, 32.1-25, and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; amended, Virginia Register Volume 23, Issue 10, eff. March 1, 2007; Volume 37, Issue 17, eff. May 27, 2021; Volume 42, Issue 23, eff. August 13, 2026.

12VAC5-371-70 Complaint investigation

A. The OLC shall investigate complaints and determine if an investigation requires an on-site inspection. In making this determination, the OLC shall consider several factors, to include:

1. Whether the complainant has first-hand knowledge of the alleged incident;

2. The nursing facility's regulatory history, including the number and severity of substantiated prior complaints;

3. Whether the OLC has recently inspected the nursing facility and whether the alleged incident would have been reviewed during the prior inspection;

4. The nature of the complaint, including degree of potential serious harm to residents; and

5. Whether the complaint may be investigated pursuant to Title XVIII or Title XIX of the Social Security Act (42 USC § 301 et seq.).

B. The OLC may request records from the licensee to assist in making a determination pursuant to subsection A of this section. The licensee shall provide the requested records no more than seven calendar days after OLC makes a request pursuant to this subsection.

C. The OLC may receive complaints in written or oral form and may receive anonymous complaints.

D. When the investigation is complete, the OLC shall notify the licensee and the complainant, if known, in writing of the findings of the investigation.

E. For any licensing violation cited during a complaint investigation, the administrator or the administrator's designee shall submit a plan of correction in accordance with 12VAC5-371-55.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; amended, Virginia Register Volume 23, Issue 10, eff. March 1, 2007; Volume 37, Issue 17, eff. eff. May 27, 2021; Volume 42, Issue 23, eff. August 13, 2026.

12VAC5-371-75 Criminal records check

A. A nursing facility may not hire for compensated employment a person who has been convicted of a barrier crime, unless:

1. The person has been convicted of a single barrier crime punishable as a misdemeanor;

2. The conviction does not involve abuse or neglect; and

3. Five years have elapsed since the conviction.

B. A nursing facility shall:

1. Obtain from an applicant for compensated employment a sworn disclosure;

2. Attach the sworn disclosure to and file it with the criminal record report; and

3. Obtain a criminal record report on applicants for compensated employment from the Virginia Department of State Police no more than 30 calendar days after employment begins.

C. A nursing facility may not accept:

1. A criminal record report dated more than 90 calendar days prior to the start date of employment; or

2. Duplicates or copies of the original criminal record report, except as provided in subsection D of this section.

D. If a nursing facility uses a temporary staffing agency for substitute staff, a nursing facility shall obtain a letter from the temporary staffing agency that includes:

1. The name of the substitute staffing person;

2. The date of employment by the temporary staffing agency; and

3. A statement verifying that the criminal record report:

a. Has been obtained within 30 calendar days of employment at the temporary staffing agency;

b. Is on file at the temporary staffing agency; and

c. Does not contain a conviction for a barrier crime, or indicates the substitute staffing person has been convicted of a single barrier crime punishable as a misdemeanor that does not involve abuse or neglect and five years have elapsed since the conviction.

E. A nursing facility may not permit a compensated employee to work in a position that involves direct contact with a patient until an original criminal record report has been received by the nursing facility or temporary staffing agency, unless the employee works under the direct supervision of another compensated employee for whom a background check has been completed in accordance with subsection B of this section.

F. A nursing facility shall obtain a new criminal record report and a new sworn disclosure if an individual:

1. Terminates compensated employment at one nursing facility and begins compensated employment at another nursing facility, unless the nursing facilities are owned by the same entity. The employee's file shall contain a statement indicating the original criminal record report has been transferred or forwarded to the new work location; or

2. Takes a leave of absence exceeding six consecutive months.

G. A nursing facility shall provide a copy of the criminal record report to an applicant denied compensated employment because of convictions appearing on his criminal record report.

H. A nursing facility shall maintain the confidentiality of criminal record reports and store criminal record reports in locked files accessible only to the administrator or designee.

I. A nursing facility may not disseminate the criminal record report and sworn disclosure except to a federal or state authority or court as may be required to comply with an express requirement of law for such further dissemination.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 17, eff. May 27, 2021.

12VAC5-371-80 Variances

A. The commissioner may authorize variances only to its own licensing standards, not to regulations of another agency or to any requirements in federal, state, or local laws.

B. A nursing facility may request a variance to a particular standard or requirement contained in this chapter when the standard or requirement poses a special hardship and when a variance to it would not endanger the safety or well-being of residents, employees, or the public.

C. Upon finding that the enforcement of one or more of the standards would be clearly impractical, the commissioner shall have the authority to waive, either temporarily or permanently, the enforcement of one or more of these standards, provided safety, resident care and services are not adversely affected.

D. The commissioner may rescind or modify a variance if (i) conditions change; (ii) additional information becomes known which alters the basis for the original decision; (iii) the nursing facility fails to meet any conditions attached to the variance; or (iv) results of the variance jeopardize the safety, comfort, or well-being of residents, employees and the public.

E. Consideration of a variance is initiated when a written request is submitted to the director of the OLC. The OLC may provide consultation in the development of the written request and throughout the variance process.

F. The request for a variance must describe the special hardship to the existing program or to a planned innovative or pilot program caused by the enforcement of the requirements. When possible, the request should include proposed alternatives to meet the purpose of the requirements which will ensure the protection and well-being of residents, employees, and the public.

G. The OLC shall notify the nursing facility of the receipt of the request for a variance. The commissioner may attach conditions to the granting of the variance in order to protect persons in care.

H. When the decision is to deny a request for a variance, the reason shall be provided in writing to the licensee.

I. When a variance is denied, expires, or is rescinded, routine enforcement of the standard or portion of the standard shall be resumed. The nursing facility may at any time withdraw a request for a variance.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; amended, Virginia Register Volume 23, Issue 10, eff. March 1, 2007; Volume 37, Issue 17, eff. eff. May 27, 2021.

12VAC5-371-90 Disciplinary action

A. The licensee may not:

1. Violate the provisions of this chapter or Article 1 (§ 32.1-123 et seq.) or 2 (§ 32.1-138 et seq.) of Chapter 5 of Title 32.1 of the Code of Virginia;

2. Permit, aid, or abet the commission of any illegal act in the nursing facility; or

3. Engage in a pattern of violations of § 38.2-3445.01 of the Code of Virginia.

B. The commissioner may:

1. For each violation of subsection A of this section:

a. Deny, revoke, or suspend the license to operate the nursing facility;

b. Restrict or prohibit new admissions to any nursing facility in accordance with the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia);

c. Refer the licensee for criminal prosecution pursuant to § 32.1-27 A of the Code of Virginia;

d. Petition an appropriate court for an injunction, mandamus, or other appropriate remedy against the licensee pursuant to § 32.1-27 B of the Code of Virginia;

e. Petition an appropriate court for imposition of a civil monetary penalty against the licensee pursuant to § 32.1-27 C or 32.1-27.1 A of the Code of Virginia; or

f. Petition an appropriate court for appointment of a receiver pursuant to § 32.1-27.1 B of the Code of Virginia; and

2. For each violation of subdivision A 3 of this section, levy a fine upon the licensee in an amount not to exceed $1,000 per violation, in accordance with the Administrative Process Act.

C. Suspension of a license shall in all cases be for an indefinite time.

D. For each violation of subsection A of this section and with the consent of the person who has violated subsection A of this section, the board may provide, in an order issued by the board, for the payment of civil charges for past violations in specific sums, which may not exceed the limits specified in § 32.1-27 or 32.1-27.1 of the Code of Virginia.

E. Upon receipt of a completed application and a nonrefundable service charge, the commissioner may issue a new license to the licensee that has had its license revoked if the commissioner determines that:

1. The conditions upon which revocation was based have been corrected; and

2. The applicant is in compliance with this chapter, Articles 1 (§ 32.1-123 et seq.) and 2 (§ 32.1-138 et seq.) of Chapter 5 of Title 32.1 of the Code of Virginia, and all other applicable state and federal law and regulations.

F. Upon receipt of a completed application, the commissioner may partially or completely restore a suspended license to the licensee if the commissioner determines that:

1. The conditions upon which suspension was based have been completely or partially corrected; and

2. The interests of the public will not be jeopardized by resumption of operation.

G. The commissioner may not require an additional fee for restoring a license pursuant to subsection F of this section.

H. The licensee shall submit evidence relevant to subdivisions E 1, E 2, F 1, and F 2 of this section that is satisfactory to the commissioner or the commissioner's designee. The commissioner or the commissioner's designee may conduct an inspection prior to making a determination.

History

• Statutory Authority: §§ 32.1-12, 32.1-27, 32.1-27.1, and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; amended, Virginia Register Volume 23, Issue 10, eff. March 1, 2007; Volume 42, Issue 23, eff. August 13, 2026.

12VAC5-371-100 Surrender of license; mid-term change of license

A. Upon revocation or suspension of a license, the licensee shall surrender its license to the OLC.

B. A licensee shall notify the director of the OLC in writing by submitting a mid-term change application no fewer than 30 calendar days in advance of implementing any:

1. Change of location of the nursing facility;

2. Change of ownership of the nursing facility;

3. Change of operator of the nursing facility;

4. Change of name of the nursing facility;

5. Change of bed capacity, except as provided in 12VAC5-371-40 G, which shall be accompanied by an approved Certificate of Public Need if the requested change is for an increase in bed capacity;

6. Change in management contract or lease agreement to operate the nursing facility;

7. Change of services being provided, including any proposed addition or discontinuation, regardless of whether licensure is required for the service; or

8. Closure of the nursing facility.

C. The OLC shall:

1. Consider the submission date of a mid-term change application to be the date the application is postmarked or the date it is received, whichever is earlier; and

2. Notify the licensee in writing if the commissioner will issue a changed license.

D. The commissioner's issuance of changed license to the licensee shall satisfy the requirements of subdivision C 2 of this section.

E. Upon receipt of the changed license, the licensee shall surrender its prior license issued by the commissioner to the OLC and destroy any copies of the prior license.

F. A license may not be transferred or assigned. The commissioner may not issue a changed license in response to a change of operator of the nursing facility, but shall instead require the nursing facility to obtain a new license. If the nursing facility intends to implement a change of operator, it shall:

1. File for a new license, in accordance with 12VAC5-371-40, no fewer than 30 calendar days in advance of any operator change; and

2. Upon receipt of the new license, surrender its prior license issued by the commissioner to the OLC and destroy any copies of the prior license.

G. If the nursing facility is closing or will otherwise no longer be operational, it shall:

1. Notify residents, legal representatives, and the OLC no fewer than seven calendar days prior to closing or ceasing operations, where all clinical records are to be located following closure or cessation of operations; and

2. Surrender its license to the OLC and destroy all copies of its license no more than five calendar days after the nursing facility closes or ceases operations.

H. The OLC shall determine if any changes listed in subsection B of this section affect the terms of the license or the continuing eligibility for a license. An inspector may inspect the nursing facility during the process of evaluating a proposed change.

History

• Statutory Authority: §§ 32.1-12, 32.1-125, and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; amended, Virginia Register Volume 23, Issue 10, eff. March 1, 2007; Volume 42, Issue 23, eff. August 13, 2026.

Part II Administrative Services

12VAC5-371-110 Management and administration

A. No person shall own, establish, conduct, maintain, manage, or operate any nursing facility, as defined in § 32.1-123 of the Code of Virginia, without having obtained a license.

B. The nursing facility must comply with:

1. This chapter;

2. Other applicable federal, state, or local laws and regulations; and

3. The nursing facility's own policies and procedures.

C. The nursing facility shall submit or make available reports and information necessary to establish compliance with this chapter and applicable statutes.

D. The nursing facility shall permit representatives from the OLC to conduct inspections to:

1. Verify application information;

2. Determine compliance with this chapter;

3. Review necessary records; and

4. Investigate complaints.

E. The nursing facility shall fully disclose its admission policies, including any preferences given, to applicants for admission.

F. The nursing facility shall identify its operating elements and programs, the internal relationship among these elements and programs, and the management or leadership structure.

G. Unless the vaccination is medically contraindicated or the resident declines the offer of vaccination, the nursing facility shall provide or arrange for the administration to its residents of an annual influenza vaccination and a pneumococcal vaccination in accordance with the following recommendations of ACIP:

1. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices - United States, 2022–23 Influenza Season, MMWR 71 (1), 2022, CDC;

2. Use of 15-Valent Pneumococcal Conjugate Vaccine and 20-Valent Pneumococcal Conjugate Vaccine Among U.S. Adults: Updated Recommendations of ACIP - United States, MMWR 71 (4), 2022, CDC;

3. Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine Among Adults Aged > 65 Years: Updated Recommendations of ACIP, MMWR 68 (46), 2019, CDC;

4. Intervals Between PCV13 and PPSV23 Vaccines: Recommendations of ACIP, MMWR 64 (34), 2015, CDC;

5. Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine Among Adults Aged > 65 Years: Recommendations of ACIP, MMWR 63 (37), 2014, CDC;

6. Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine Among Children Aged 6 - 18 Years with Immunocompromising Conditions: Recommendations of ACIP, MMWR 62 (25), 2013, CDC;

7. Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine for Adults with Immunocompromising Conditions: Recommendations of ACIP, MMWR 61 (40), 2012, CDC;

8. Prevention of Pneumococcal Disease Among Infants and Children - Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine: Recommendations of ACIP, MMWR 59 (RR-11), 2010, CDC; and

9. Updated Recommendations for Prevention of Invasive Pneumococcal Disease Among Adults Using the 23-Valent Pneumococcal Polysaccharide Vaccine (PPSV23), MMWR 59 (34), 2010, CDC.

H. Upon request of the nursing facility's family council, the nursing facility shall send notices and information about the family council mutually developed by the family council and the administration of the nursing facility, and provided to the nursing facility for such purpose, to the legal representative or a contact person of the resident's choice up to six times a year. Such notices may be included together with a monthly billing statement or other regular communication. Notices and information shall also be posted in a designated location within the nursing facility.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; amended, Virginia Register Volume 20, Issue 26, eff. September 27, 2004; Volume 23, Issue 10, eff. March 1, 2007; Volume 27, Issue 24, eff. September 1, 2011; Volume 37, Issue 17, eff. May 27, 2021; Volume 42, Issue 23, eff. August 13, 2026.

12VAC5-371-120 Governing body

A. The nursing facility shall have a governing body that is legally responsible for the management of the operation.

B. The governing body shall adopt written bylaws that describe the organizational structure and establish authority and responsibility in accordance with applicable laws, including a:

1. Statement of purpose;

2. Description of the functions of the governing body members, officers and committees;

3. Description of the method of adoption, implementation, and periodic review of policies and procedures; and

4. Description of the methods to be utilized to assure compliance with this chapter.

C. The governing body shall disclose the names and addresses of any individual or entity that holds 5.0% or more ownership interest in the operation of the nursing facility.

D. When the governing body is not the owner of the physical plant, the governing body shall disclose the name and address of the individual or entity responsible for the alterations, modifications, maintenance and repairs to the building.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; amended, Virginia Register Volume 23, Issue 10, eff. March 1, 2007; Volume 37, Issue 17, eff. May 27, 2021.

12VAC5-371-130 Administrator

A. The governing body shall appoint an individual, on a full-time basis, to serve as its on-site agent, responsible for the day-to-day administration and management.

B. The governing body shall provide the OLC with evidence that the individual appointed as administrator is:

1. Currently licensed by the Virginia Board of Long-Term Care Administrators; or

2. Holds a current administrator's license in another state and has filed an application for license with the Virginia Board of Long-Term Care Administrators.

C. Within five working days of the effective date of termination of the administrator's employment, the governing body shall notify the OLC, in writing, of the name and qualifications of the replacement administrator or the acting administrator.

D. The governing body shall appoint a qualified administrator within 90 days of the effective date of the termination of the previously qualified administrator, and shall provide the OLC with written notification of the administrator's name, license number, and effective date of employment.

An additional 30-day extension may be granted if a written request provides documentation that the individual designated as administrator is awaiting the final licensing decision of the Virginia Board of Long-Term Care Administrators.

E. The governing body shall assure that administrative direction is provided at all times. The governing body, the administrator, or the chief executive officer shall designate, in writing, a qualified individual to act as the alternate nursing home administrator in the absence of the administrator .

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; amended, Virginia Register Volume 23, Issue 10, eff. March 1, 2007; Volume 37, Issue 17, eff. May 27, 2021.

12VAC5-371-140 Policies and procedures

A. The nursing facility shall implement written policies and procedures approved by the governing body.

B. All policies and procedures shall be reviewed at least annually, with recommended changes submitted to the governing body for approval.

C. A written record of the annual policy review, including at least the review dates, participants, recommendations and action dates of the governing body, shall be maintained.

D. Administrative and operational policies and procedures shall include:

1. Administrative records;

2. Admission, transfer and discharge;

3. Medical direction and physician services;

4. Nursing direction and nursing services;

5. Pharmaceutical services, including drugs purchased outside the nursing facility;

6. Dietary services;

7. Social services;

8. Activities services;

9. Restorative and rehabilitative resident services;

10. Contractual services;

11. Clinical records;

12. Resident rights and grievances;

13. Quality assurance and infection control and prevention;

14. Safety and emergency preparedness procedures;

15. Professional and clinical ethics, including:

a. Confidentiality of resident information;

b. Truthful communication with residents;

c. Observance of appropriate standards of informed consent and refusal of treatment; and

d. Preservation of resident dignity, with special attention to the needs of the aged, the cognitively impaired, and the dying; and

16. Nursing facility security.

E. Personnel policies and procedures shall include:

1. Written job descriptions that specify authority, responsibility, and qualifications for each job classification;

2. An on-going plan for employee orientation, staff development, in-service training and continuing education;

3. An accurate and complete personnel record for each employee including:

a. Verification of current professional license, registration, or certificate or completion of a required approved training course;

b. Criminal record check;

c. Verification that the employee has reviewed or received a copy of the job description;

d. Orientation to the nursing facility, its policies and to the position and duties assigned;

e. Completed continuing education program approved for the employee as determined by the outcome of the annual performance evaluation;

f. Annual employee performance evaluations; and

g. Disciplinary action taken; and

4. Employee health-related information retained in a file separate from personnel files.

F. Financial policies and procedures shall include:

1. Admission agreements;

2. Methods of billing:

a. Services not included in the basic daily or monthly rate;

b. Services delivered by contractors of the nursing facility; and

c. Third party payers;

3. Resident or designated representative notification of changes in fees and charges;

4. Correction of billing errors and refund policy;

5. Collection of delinquent resident accounts; and

6. Handling of resident funds.

G. A nursing facility shall establish and implement policies to ensure the permissible access to and use of an intelligent personal assistant provided by a patient while receiving inpatient services. Such policies shall ensure protection of health information in accordance with the requirements of the federal Health Insurance Portability and Accountability Act of 1996 (42 USC § 1320d et seq.).

H. Policies shall be made available for review, upon request, to residents and their designated representatives.

I. Policies and procedures shall be readily available for staff use at all times.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; amended, Virginia Register Volume 27, Issue 24, eff. September 1, 2011; Volume 37, Issue 17, eff. May 27, 2021; Volume 38, Issue 4, eff. November 11, 2021.

12VAC5-371-150 Resident rights

A. The nursing facility shall develop and implement policies and procedures that ensure a resident's rights as defined in §§ 32.1-138 and 32.1-138.1 of the Code of Virginia.

B. The procedures shall:

1. Not restrict any right a resident has under law;

2. Provide staff training to implement resident rights; and

3. Include grievance procedures.

C. The name and telephone number of the complaint coordinator of the OLC, the Adult Protective Services toll-free telephone number, and the toll-free telephone number for the State Ombudsman shall be conspicuously posted in a public place.

D. Copies of resident rights shall be given to residents upon admittance to the nursing facility and made available to residents currently in residence, to legal representatives, next of kin, or sponsoring agency or agencies, and to the public.

E. The nursing facility shall have a plan to review resident rights with each resident annually, or with the legal representative at least annually, and have a plan to advise each staff member at least annually.

F. The nursing facility shall certify, in writing, that it is in compliance with the provisions of §§ 32.1-138 and 32.1-138.1 of the Code of Virginia, relative to resident rights, as a condition of license issuance or renewal.

G. The nursing facility shall register with the Department of State Police to receive notice of the registration, reregistration, or verification of any person required to register with the Sex Offender and Crimes Against Minors Registry pursuant to Chapter 9 (§ 9.1-900 et seq.) of Title 9.1 of the Code of Virginia within the same or a contiguous zip code area in which the nursing facility is located pursuant to § 9.1-914 of the Code of Virginia.

H. Prior to admission, each nursing facility shall ascertain if a potential resident is required to register with the Sex Offender and Crimes Against Minors Registry pursuant to Chapter 9 of Title 9.1 of the Code of Virginia if the potential resident:

1. Is anticipated by the nursing facility to have a length of stay longer than three days; or

2. In fact stays longer than three days.

I. The nursing facility shall not restrict the rights of a resident's family and legal representative to meet in the nursing facility with the families and legal representatives of other residents.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; amended, Virginia Register Volume 17, Issue 1, eff. October 27, 2000; Volume 23, Issue 10, eff. March 1, 2007; Volume 24, Issue 11, eff. March 5, 2008; Volume 34, Issue 11, eff. February 21, 2018; Volume 37, Issue 17, eff. May 27, 2021; Volume 42, Issue 23, eff. August 13, 2026.

12VAC5-371-160 Financial controls and resident funds

A. All financial records, including resident funds, shall be kept according to generally accepted accounting principles (GAAP).

B. Each nursing facility shall maintain, per facility, noneroding general liability insurance coverage in a minimum amount of $1 million per occurrence, and professional liability coverage in an amount at least equal to the recovery limit set forth in § 8.01-581.15 of the Code of Virginia per patient occurrence, to compensate residents or individuals for injuries and losses resulting from the negligent acts of the nursing facility. Failure to maintain minimum insurance limits under this section shall result in revocation of the nursing facility's license. Each nursing facility shall provide at licensure renewal or have available to the board proof of the insurance coverages as required by this subsection.

C. Nursing facilities choosing to handle resident funds shall:

1. Comply with § 32.1-138 A 7 of the Code of Virginia regarding resident funds;

2. Purchase a surety bond or otherwise provide assurance for the security of all personal funds deposited with the nursing facility; and

3. Provide for separate accounting for resident funds.

D. In the event the nursing facility is sold, the nursing facility shall provide written verification that all resident funds have been transferred and shall obtain a signed receipt from the new owner. Upon receipt, the new owner shall provide an accounting of resident funds.

E. Each nursing facility shall be required to provide a full refund of any unexpended patient funds on deposit with the nursing facility following the discharge or death of a patient, other than entrance related fees, within 30 days of a written request for such funds by the discharged patient or, in the case of the death of a patient, the person administering the patient's estate in accordance with the Virginia Small Estate Act (§ 64.2-600 et seq. of the Code of Virginia).

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; amended, Virginia Register Volume 23, Issue 10, eff. March 1, 2007; Volume 30, Issue 3, eff. November 8, 2013; Volume 34, Issue 11, eff. February 21, 2018; Volume 37, Issue 17, eff. May 27, 2021; Volume 42, Issue 5, eff. November 19, 2025.

12VAC5-371-170 Quality assessment and assurance

A. The nursing facility shall maintain a quality assessment and assurance committee consisting of at least the following individuals:

1. The director of nursing services;

2. A physician designated by the nursing facility; and

3. At least three other members of the nursing facility staff, one of whom demonstrates an ability to represent the rights and concerns of residents.

B. The quality assessment and assurance committee shall:

1. Meet at least quarterly to identify issues which would improve quality of care and services provided to residents; and

2. Develop and implement appropriate plans of action to correct identified deficiencies.

C. The nursing facility shall document compliance with these requirements.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; amended, Virginia Register Volume 37, Issue 17, eff. May 27, 2021.

12VAC5-371-180 Infection control

A. The nursing facility shall establish and maintain an infection control program designed to provide a safe, sanitary, and comfortable environment and to prevent the development and transmission of disease and infection.

B. The infection control program shall encompass the entire physical plant and all services.

C. The infection control program addressing the surveillance, prevention, and control of infections in the nursing facility shall include:

1. Procedures to isolate the infecting organism;

2. Access to handwashing equipment for staff;

3. Training of staff in proper handwashing techniques, according to accepted professional standards, to prevent cross-contamination;

4. Implementation of universal precautions by direct resident care staff;

5. Prohibiting employees with communicable diseases or infections from direct contact with residents or resident food if direct contact will transmit disease;

6. Monitoring staff performance of infection control practices;

7. Handling, storing, processing, and transporting linens, supplies, and equipment in a manner that prevents the spread of infection;

8. Handling, storing, processing, and transporting regulated medical waste in accordance with applicable regulations;

9. Maintaining an effective pest control program; and

10. Staff education regarding infection risk-reduction behavior.

D. The nursing facility shall report promptly to its local health department diseases designated as "reportable" according to 12VAC5-90-80 when such cases are admitted to or are diagnosed in the nursing facility and shall report any outbreak of infectious disease as required by 12VAC5-90. An outbreak is defined as an increase in incidence of any infectious disease above the usual incidence at the nursing facility.

E. During a declared public health emergency related to a communicable disease of public health threat, the nursing facility shall establish a protocol to allow residents to receive visits from a rabbi, priest, minister, or clergy member of any religious denomination or sect consistent with guidance from the CDC and CMS and subject to compliance with any executive order, order of public health, department guidance, or any other applicable federal or state guidance having the effect of limiting visitation.

1. Such protocol may restrict the frequency and duration of visits and may require visits to be conducted virtually using interactive audio or video technology.

2. Any such protocol may require the person visiting a resident pursuant to this subsection to comply with all reasonable requirements of the nursing facility adopted to protect the health and safety of the person, residents, and staff of the nursing facility.

F. During a public health emergency related to COVID-19, a nursing facility shall establish a protocol to allow each resident to receive visits, consistent with guidance from the CDC and as directed by CMS and the board, which shall include:

1. Provisions describing:

a. The conditions, including conditions related to the presence of COVID-19 in the nursing facility and community, under which in-person visits will be allowed and under which in-person visits will not be allowed and visits will be required to be virtual;

b. The requirements with which in-person visitors will be required to comply to protect the health and safety of the residents and staff of the nursing facility;

c. The types of technology, including interactive audio or video technology, and the staff support necessary to ensure visits are provided as required by this subsection; and

d. The steps the nursing facility will take in the event of a technology failure, service interruption, or documented emergency that prevents visits from occurring as required by this subsection;

2. A statement of the frequency with which visits, including virtual and in-person, where appropriate, will be allowed, which shall be at least once every 10 calendar days for each resident;

3. A provision authorizing a resident or the resident's personal representative to waive or limit visitation, provided that such waiver or limitation is included in the resident's health record; and

4. A requirement that the nursing facility publish on its website or communicate to each resident or the resident's authorized representative, in writing or via electronic means, the nursing facility's plan for providing visits to residents as required by this subsection.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; amended, Virginia Register Volume 22, Issue 7, eff. January 11, 2006; Volume 37, Issue 17, eff. May 27, 2021; Volume 38, Issue 4, eff. November 11, 2021; Volume 42, Issue 23, eff. August 13, 2026.

12VAC5-371-190 Safety and emergency procedures

A. A written emergency preparedness plan shall be developed, reviewed, and implemented when needed. The plan shall address responses to natural disasters, as well as fire or other emergency which disrupts the normal course of operations. The plan shall address provisions for relocating residents and also address staff responsibilities for:

1. Alerting emergency personnel and sounding alarms;

2. Implementing evacuation procedures including the evacuation of residents with special needs;

3. Using, maintaining and operating emergency equipment;

4. Accessing resident emergency medical information; and

5. Utilizing community support services.

B. All staff shall participate in periodic emergency preparedness training.

C. Staff shall have documented knowledge of, and be prepared to implement, the emergency preparedness plan in the event of an emergency.

D. At least one telephone shall be available in each area to which residents are admitted and additional telephones or extensions as are necessary to ensure availability in case of need.

E. In the event of a disaster, fire, emergency or any other condition that may jeopardize the health, safety and well-being of residents, the nursing facility shall notify the OLC of the conditions and status of the residents and the physical plant as soon as possible.

F. The nursing facility shall have a policy on smoking.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; amended, Virginia Register Volume 23, Issue 10, eff. March 1, 2007; Volume 37, Issue 17, eff. May 27, 2021.

12VAC5-371-191 Electronic monitoring in resident rooms

A. All requests for electronic monitoring shall be made in writing and signed by the resident or, if the resident has been legally deemed incompetent, the resident's legal representative.

B. Electronic monitoring shall be permitted only:

1. Upon the informed consent of the resident or resident's legal representative, which shall be obtained prior to the installation or use of any electronic monitoring device. Consent for electronic monitoring shall be kept in the resident's medical record;

2. If the resident resides:

a. In a room with no roommates; or

b. In a room with roommates and obtains written consent to visual recording from the roommates or, if a roommate has been legally deemed incompetent, the roommate's legal representative. If a resident resides with roommates, only video electronic monitoring shall be permitted pursuant to this subsection;

3. Upon execution of an agreement for the sharing and release of medical data and information protected by the federal Health Insurance Portability and Accountability Act of 1996 (42 USC § 1320d et seq.) signed by the resident or resident's legal representative or, if applicable, any such agreement signed by a roommate or roommate's legal representative shall be kept in all consenting individuals' medical records; and

4. If the nursing facility has secured and password-protected wireless Internet access or other means available to operate the electronic monitoring device without modification to the nursing facility or a change in level or capacity of Internet access.

C. A nursing facility shall allow electronic monitoring of a resident of a nursing facility if the electronic monitoring is conducted in accordance with this section. A nursing facility shall not refuse to admit an individual and shall not discharge or transfer a resident due to a request to conduct authorized electronic monitoring.

D. No family member may implement or activate electronic monitoring over the objections of or contrary to the instructions of the resident or the resident's legal representative. No electronic monitoring equipment may be installed over the objections of or contrary to the instructions of the resident or resident's legal representative.

E. A nursing facility shall designate one or more staff persons to be the point of contact for electronic monitoring requests and for providing information and policies upon request during normal business hours.

F. Except as provided in subsection O of this section, a nursing facility may assume custodial ownership of any recordings from electronic monitoring devices from the resident or resident's legal representative. Recordings from electronic monitoring devices shall not be considered part of the resident's medical record.

G. If a nursing facility chooses to assume ownership of recordings from electronic monitoring devices pursuant to subsection F of this section, the nursing facility shall not permit viewings of recordings without consent of the resident or legal representative except to the extent that disclosure is required by law for quality assurance purposes. If unauthorized viewing is discovered, the nursing facility shall report any such violation to the Office of Long-Term Care Ombudsman and to the OLC.

H. No nursing facility shall be held liable for any breach of data or privacy related to the presence of the electronic monitoring device.

I. A nursing facility shall require facility staff to immediately report any incidents regarding safety or quality of care discovered or reported to staff as a result of viewing a recording from an electronic monitoring device to the administrator of the nursing facility and to the OLC. Nursing facilities shall instruct the resident or legal representative of this reporting requirement and shall provide the resident or the resident's legal representative with the OLC's complaint hotline telephone number.

J. A nursing facility shall have no obligation to seek access to a recording for which the nursing facility has not assumed custodial ownership or to have knowledge of a recording's content, unless (i) the nursing facility is aware of a recorded incident of suspected abuse or neglect or an accident or injury based upon a report received by the facility of such incident, accident, or injury or (ii) the resident, the resident's legal representative, or a government agency seeks to use a recording.

K. Unless a nursing facility chooses to assume ownership of any recordings from an monitoring device, the resident or resident's legal representative shall be responsible for all aspects of the operation of the electronic monitoring device, including the removal and replacement of recordings; adherence to local, state, and federal privacy laws; and for firewall protections to prevent images that would violate obscenity laws from being inadvertently shown on the Internet.

L. A nursing facility shall prohibit assigned staff from refusing to enter a resident's room solely because of electronic monitoring.

M. A nursing facility shall make reasonable physical accommodations for electronic monitoring devices, including:

1. Providing a reasonably secure place to mount the device; and

2. Providing reasonable access to power sources if already in proximity to the device.

N. A nursing facility shall require a resident or resident's legal representative to pay for all costs, other than the cost of electricity, associated with the purchase and installation of the electronic monitoring device. In addition, a nursing facility offering facility-managed electronic monitoring may charge a one-time fee not to exceed $150 when the electronic monitoring device is installed along with a security deposit not to exceed $250. A nursing facility may charge a monthly fee not to exceed $10 to cover costs associated with the electronic monitoring device. Such costs may include equipment, secured and password-protected wireless Internet and server capabilities, compliance with life safety and building and electrical codes, maintenance or removal of the equipment, posting and removal of any public notices, or structural repairs to the building resulting from the removal of the equipment. Nursing facilities shall give 45 days of notice of an increase in monthly fees.

O. The resident of a room with an electronic monitoring device or the resident's legal representative may verbally or in writing condition consent for the installation or use of the electronic monitoring device. The conditions on consent may include (i) the ability of the resident, a roommate, or staff at the request of the resident or any roommate, to turn off or disable the audio or video electronic monitoring device during certain periods of time and (ii) a prohibition on the ability of the nursing facility to, pursuant to subsection F of this section, choose to assume custodial ownership of recordings from the electronic monitoring device after the electronic monitoring device has been installed and is operational. If the resident or resident's legal representative or any roommate or roommate's legal representative places conditions on consent, the nursing facility and staff shall ensure that the installation, use, and operation of the electronic monitoring device and electronic monitoring or other activities be conducted in connection with the electronic monitoring are conducted in compliance with the conditions.

P. The nursing facility shall conspicuously post and maintain a notice at the entrance to the resident's room stating that an electronic monitoring device is in operation.

Q. A nursing facility shall notify assigned staff for the resident and the long-term care division of the OLC when electronic monitoring is in use in a resident's room pursuant to this section.

R. A nursing facility shall prohibit staff from covert monitoring in violation of this chapter. Nursing facilities shall instruct the resident or legal representative of this prohibition and shall provide the resident or the resident's legal representative with the OLC's complaint hotline telephone number.

S. If covert monitoring is discovered, the nursing facility shall report any such violation to the Office of Long-Term Care Ombudsman and OLC, and the nursing facility may require a resident or a resident's legal representative to meet all the requirements for authorized monitoring, if permitted by the nursing facility.

T. Nursing facilities shall instruct the resident or the resident's legal representative of this prohibition and shall provide the resident or the resident's legal representative with the OLC's complaint hotline telephone number.

U. A nursing facility shall adopt policies and procedures for electronic monitoring consistent with this section.

V. A nursing facility shall adopt a policy prohibiting staff from willfully tampering with electronic monitoring devices in violation of this section. Adjusting or disabling an electronic monitoring device during the provision of patient care shall not constitute willful tampering if the adjusting or disabling is done in order to protect the dignity of a resident or at the direction of the resident or resident's legal representative.

W. If the placement or position of the electronic monitoring device creates risk to a nursing facility employee, resident, or roommate or if the resident or resident's legal representative or family member violates the nursing facility's policies and procedures for electronic monitoring, the equipment may be disabled and removed and the nursing facility shall notify the resident, resident's legal representative, or family member responsible for the camera of the removal.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 35, Issue 5, eff. December 13, 2018; amended, Virginia Register Volume 37, Issue 17, eff. May 27, 2021; Volume 42, Issue 5, eff. November 19, 2025; Errata 42:26 VA.R. 2379 August 10, 2026.

Part III Resident Services

12VAC5-371-200 Director of nursing

A. Each nursing facility shall employ a full-time director of nursing to supervise the delivery of nursing services. The individual hired shall be a registered nurse licensed by the Virginia Board of Nursing.

B. The duties and responsibilities of the director of nursing shall include, but are not limited to:

1. Developing and maintaining (i) nursing service objectives, (ii) standards of practice, (iii) policy and procedure manuals, and (iv) job descriptions for each level of nursing personnel;

2. Recommending to the administrator the resources needed to carry out nursing service, including but not limited to, equipment and supplies and the number and level of nursing personnel to be employed;

3. Participating in the employment of nursing personnel, including (i) recruitment, (ii) selection, (iii) position assignment, (iv) orientation, (v) in-service education, (vi) supervision, (vii) evaluation, and (viii) termination;

4. Participating with the medical director in developing and implementing policies for resident care;

5. Assuring that the comprehensive plan of care is maintained in conjunction with other disciplines;

6. Coordinating nursing services with other services such as medical, rehabilitative, and social services and the resident activity program;

7. Participating in quality assurance committee meetings to identify issues and to develop and implement appropriate plans of action to correct identified problems;

8. Making daily rounds on resident floors, unless this duty has been delegated to another licensed nurse; and

9. Recommending and coordinating the training needs of nursing staff with the individual responsible for in-service training.

C. A registered nurse, designated in writing by the administrator, shall serve in the temporary absence of the director of nursing so there is the equivalent of a full-time director of nursing on duty for a minimum of five days a week.

D. The director of nursing shall not function as a nursing supervisor in facilities with 60 or more beds.

E. The nursing facility shall notify the OLC, in writing, within five days of a vacancy in the director of nursing position. The written notice shall give the name and Virginia license number of the individual appointed to serve as director of nursing, and whether the appointment is permanent or temporary.

F. The director of nursing position shall not be held by a temporary designate for more than 90 days. Temporary agency personnel shall not be utilized to fill the director of nursing position.

G. Written notification, giving the name and license number of the individual, shall be sent to the OLC when a permanent appointment is made.

H. A license for a new nursing facility or an increase in bed size in an existing nursing facility shall not be issued if the director of nursing position is vacant.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; amended, Virginia Register Volume 23, Issue 10, eff. March 1, 2007.

12VAC5-371-210 Nurse staffing

A. A nursing supervisor, designated by the director of nursing, shall be responsible for all nursing activities in the nursing facility, or in the section to which assigned, including:

1. Making daily visits to determine resident physical, mental, and emotional status and implementing any required nursing intervention;

2. Reviewing medication records for completeness, accuracy in the transcription of physician orders, and adherence to stop-order policies;

3. Reviewing resident plans of care for appropriate goals and approaches, and making revisions based on individual needs;

4. Assigning to the nursing staff responsibility for nursing care;

5. Supervising and evaluating performance of all nursing personnel on the unit; and

6. Keeping the director of nursing services, or director of nursing designee, informed of the status of residents and other related matters.

B. The nursing facility shall provide qualified nurses and certified nurse aides on all shifts, seven days per week, in sufficient number to meet the assessed nursing care needs of all residents.

C. Nursing personnel, including registered nurses, licensed practical nurses, and certified nurse aides shall be assigned duties consistent with their education, training and experience.

D. Weekly time schedules shall be maintained and shall indicate the number and classification of nursing personnel who worked on each unit for each shift. Schedules shall be retained for one year.

E. All nursing services shall be directly provided by an appropriately qualified registered nurse or licensed practical nurse, except for those nursing tasks that may be delegated by a registered nurse according to Part IV (18VAC19-20-240 et seq.) of the Regulations Governing the Practice of Nursing and with a plan developed and implemented by the nursing facility.

F. Before allowing a nurse aide to perform resident care duties, the nursing facility shall verify that the individual is:

1. A certified nurse aide in good standing;

2. Enrolled full-time in a nurse aide education program approved by the Virginia Board of Nursing; or

3. Has completed a nurse aide education program or competency testing, but has not yet been placed on the nurse aide registry.

G. Any person employed to perform the duties of a nurse aide on a permanent full-time, part-time, hourly, or contractual basis must be registered as a certified nurse aide within 120 days of employment.

H. Nurse aides employed or provided by a temporary personnel agency shall be certified to deliver nurse aide services.

I. The services provided or arranged with a temporary personnel agency shall meet professional standards of practice and be provided by qualified staff according to each resident's comprehensive plan of care.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; amended, Virginia Register Volume 22, Issue 7, eff. January 11, 2006; Volume 37, Issue 17, eff. May 27, 2021.

12VAC5-371-220 Nursing services

A. Each nursing facility shall implement written resident care policies and procedures which support an active program of nursing care directed toward assisting all residents to achieve outcomes consistent with their highest level of self-care and independence.

B. All medications and treatments will be administered as prescribed in the resident's medical plan of care.

C. Services shall be provided to prevent clinically avoidable complications, including, but not limited to:

1. Pressure ulcer development;

2. Contracture;

3. Loss of continence;

4. Dehydration; and

5. Malnutrition.

D. Each resident shall be given proper daily personal attention and care, including skin, nail, hair and oral hygiene, in addition to any specific care ordered by the attending physician. Provision of daily personal care shall be documented in the clinical record.

E. Each resident shall be dressed in clean clothing and be free of odors. Each resident shall be encouraged to wear day clothing when out of bed.

F. Each resident shall receive tub or shower baths as often as needed, but not less than twice weekly. Residents whose medical conditions prohibit tub or shower baths shall have a sponge bath daily.

G. Residents who are incontinent shall have a partial bath, clean clothing and linens each time their clothing or bed linen is soiled.

H. The attending physician, nurse practitioner or physician assistant and the resident's family or responsible party shall be notified of any changes in a resident's condition which indicate a need to alter medical treatment.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997.

12VAC5-371-230 Medical direction

A. Each nursing facility shall have a written agreement with one or more physicians licensed by the Virginia Board of Medicine to serve as medical director.

B. The duties of the medical director shall include, but are not limited to:

1. Advising the administrator and the director of nursing on medical issues, including the criteria for residents to be admitted, transferred or discharged from the nursing facility;

2. Advising on the development and execution of policies and procedures that have a direct effect upon the quality of medical and nursing care delivered to residents;

3. Acting as liaison and consulting with the administrator and the attending physician on matters regarding medical and nursing care policies and procedures of the nursing facility;

4. Advising and providing consultation to the nursing facility staff regarding communicable diseases, infection control and isolation procedures, and serving as liaison with local health officials;

5. Providing temporary physician services when the admitting physician is not the attending physician, in order to assure that the resident has temporary medical orders;

6. Providing physician services in case of emergency in the event that the resident's attending physician cannot be reached; and

7. Advising on the development and execution of an employee health program, which shall include provisions for determining that employees are free of communicable diseases according to current acceptable standards of practice.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997.

12VAC5-371-240 Physician services

A. Each resident shall be under the care of a physician licensed by the Virginia Board of Medicine. Nurse practitioners and physician assistants licensed to practice in Virginia may provide care as assigned by the supervising physician and within the parameters of professional licensing.

B. Prior to, or at the time of admission, each resident, his designated representative, or the entity responsible for his care shall designate an attending physician.

C. A complete medical plan of care must be provided at the time of admission, or within 48 hours after admission. The plan shall include:

1. Primary diagnosis;

2. Identification of resident problems;

3. Medical history and physical exam;

4. Orders for medications;

5. Treatments;

6. Restorative services;

7. Activity levels;

8. Diet;

9. Special procedures recommended for health and safety of the resident; and

10. Advance directives, if known.

D. The admission medical plan of care shall be prescribed and signed by the attending physician. Subsequent medical plans of care for the same resident may be prescribed and signed by a nurse practitioner or physician assistant according to their practice agreements.

E. The physician, nurse practitioner or physician assistant shall review the resident's medical plan of care at each visit and write a progress note.

F. Each resident shall be seen by his attending physician and the resident's total program of care shall be reviewed and appropriately revised as necessary.

G. All verbal orders shall be immediately recorded and signed by the individual receiving them, and shall be countersigned by the prescribing person.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; amended, Virginia Register Volume 22, Issue 7, eff. January 11, 2006.

12VAC5-371-250 Resident assessment and care planning

A. The nursing facility shall conduct an initial and periodic assessment of each resident's needs. The assessment shall accurately describe the resident's capability to perform daily life functions and significant impairments in functional capacity. This comprehensive assessment shall include, but is not limited to:

1. Medically defined conditions and prior medical history;

2. Medical status;

3. Physical and mental functional status;

4. Sensory and physical impairments;

5. Nutritional status and requirements;

6. Special treatments or procedures;

7. Psychosocial status;

8. Discharge potential;

9. Dental condition;

10. Activities potential;

11. Rehabilitative potential;

12. Cognitive status;

13. Drug therapy; and

14. Any known advance directives.

B. The nursing facility shall conduct a complete assessment:

1. No later than 14 days after the date of admission;

2. Promptly after a significant change in the resident's physical or mental condition; and

3. In all cases, at least once every 12 months.

C. The nursing facility shall review each resident's assessment at least once every three months and shall update the plan of care as indicated.

D. Each assessment shall be coordinated by a registered nurse who signs, dates and certifies completion of the assessment.

E. Each assessment shall be conducted or coordinated with the participation of health professionals. Each person completing a portion of the assessment shall sign and date that portion of the assessment.

F. The nursing facility shall use the results of the assessment to develop, review, and revise the resident's comprehensive plan of care.

G. A comprehensive plan of care shall be developed for each resident. The plan shall include measurable objectives and timetables to meet the resident's medical, nursing, nutritional, and psychosocial needs identified in the comprehensive assessment. The plan shall also describe the services that are to be furnished to maintain or improve the resident's physical, mental, and psychosocial status.

H. The comprehensive plan of care shall be developed within seven days of completion of the comprehensive assessment.

I. The comprehensive plan of care shall be prepared by a multidisciplinary team. The multidisciplinary team shall include a registered nurse, the attending physician, to the extent practicable, and other staff in disciplines as determined by the resident's needs. The resident, the resident's family or legal representative shall also be provided a meaningful opportunity to participate in the care planning.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997.

12VAC5-371-260 Staff development and inservice training

A. All full-time, part-time, and temporary personnel shall receive orientation to the nursing facility commensurate with their function or job-specific responsibilities.

B. All resident care staff shall receive annual inservice training commensurate with their function or job-specific responsibilities in at least the following:

1. Special needs of residents as determined by the nursing facility staff;

2. Prevention and control of infections;

3. Fire prevention or control and emergency preparedness;

4. Safety and accident prevention;

5. Restraint use, including alternatives to physical and chemical restraints;

6. Confidentiality of resident information;

7. Understanding the needs of the aged and disabled;

8. Resident rights, including personal rights, property rights and the protection of privacy, and procedures for handling complaints;

9. Care of the cognitively impaired;

10. Basic principles of cardiopulmonary resuscitation for licensed nursing staff and the Heimlich maneuver for nurse aides; and

11. Prevention and treatment of pressure sores.

C. The nursing facility shall have an ongoing training program that is planned and conducted for the development and improvement of skills of all personnel.

D. The nursing facility shall maintain written records indicating the content of and attendance at each orientation and inservice training program.

E. The nursing facility shall provide inservice programs, based on the outcome of annual performance evaluations, for nurse aides.

F. Nurse aide inservice training shall consist of at least 12 hours per anniversary year.

G. The nursing facility shall provide training on the requirements for reporting adult abuse, neglect, or exploitation and the consequences for failing to make such a required report to all its employees who are licensed to practice medicine or any of the healing arts, serving as a hospital resident or intern, engaged in the nursing profession, working as a social worker, mental health professional or law-enforcement officer and any other individual working with residents of the nursing facility.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; amended, Virginia Register Volume 17, Issue 1, eff. October 27, 2000; Volume 37, Issue 17, eff. May 27, 2021.

12VAC5-371-270 Social services

A. The nursing facility shall provide a comprehensive social services program to meet the psychosocial and medically related needs of each resident.

B. There shall be at least one designated staff member responsible for coordinating resident social services.

C. This individual shall have one of the following qualifications:

1. A bachelor's degree in social work or human services appropriate to resident needs; or

2. One year, within the last five years, supervised direct social work experience.

D. This individual shall be:

1. Trained in recognizing and assessing the emotional and social needs of residents; and

2. Knowledgeable of community agencies and resources available to meet those needs.

E. The social services coordinator shall assess each resident and participate in the development and implementation of the comprehensive plan of care.

F. Documentation of social services shall be included in the resident's clinical record.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997.

12VAC5-371-280 Resident activities

A. The nursing facility shall provide activities, on a regularly scheduled basis, specifically suited to the needs and interests of each resident based on the resident's comprehensive plan of care.

B. There shall be at least one staff member responsible for coordinating resident activities. The individual shall meet at least one of the following qualifications:

1. Be a qualified therapeutic recreation specialist or an activities professional;

2. Be eligible for certification as a therapeutic recreation specialist or activities professional by a recognized accrediting body;

3. Have one year full-time experience, within the last five years, in a patient activities program in a health care setting;

4. Be a qualified occupational therapist or occupational therapy assistant; or

5. Have completed 40 hours training in group activities and recognizing and assessing the activity needs of residents.

C. The activities coordinator shall assess each resident and participate in the development and implementation of the comprehensive plan of care.

D. The activities program shall make the fullest possible use of community social and recreational opportunities, including the involvement of volunteers and community groups.

E. Documentation of activities shall be included in the resident's clinical record.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 25, eff. September 1, 1997.

12VAC5-371-290 Special rehabilitative services

A. The nursing facility shall provide, or arrange for under written agreement, specialized rehabilitative services, such as physical therapy, speech-language pathology services and occupational therapy.

B. Specialized rehabilitative services shall be provided in accordance with accepted standards of practice by qualified therapists, or by trained assistants under the supervision of a licensed or certified therapist.

C. Rehabilitative services shall be authorized by the attending physician and a written plan of care developed in consultation with the appropriate therapist.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997.

12VAC5-371-300 Pharmaceutical services

A. Provision shall be made for the procurement, storage, dispensing, and accounting of drugs and other pharmacy products in compliance with 18VAC110-20. This may be by arrangement with an off-site pharmacy, but must include provisions for 24-hour emergency service.

B. Each nursing facility shall develop and implement policies and procedures for the handling of drugs and biologicals, including procurement, storage, administration, self-administration, and disposal of drugs.

C. Each nursing facility shall have a written agreement with a qualified pharmacist to provide consultation on all aspects of the provision of pharmacy services in the nursing facility.

D. The consultant pharmacist shall make regularly scheduled visits, at least monthly, to the nursing facility for a sufficient number of hours to carry out the function of the agreement.

E. Excluding cannabis oil,no drug or medication shall be administered to any resident without a valid verbal order or a written, dated, and signed order from a physician, dentist, podiatrist, nurse practitioner, or physician assistant licensed in Virginia.

F. Nursing facility employees who are authorized to possess, distribute, or administer medications to residents may store, dispense, or administer cannabis oil to a resident who:

1. Has been issued a valid written certification for the use of cannabis oil in accordance with § 54.1-3408.3 B of the Code of Virginia; and

2. Is registered with the Board of Pharmacy.

G. Advanced medication aides registered by the Board of Nursing pursuant to Article 7 (§ 54.1-3041 et seq.) of Chapter 30 of Title 54.1 of the Code of Virginia may administer drugs that would be administered by a registered medication aide pursuant to § 54.1-3408 M of the Code of Virginia in an assisted living facility licensed by the Department of Social Services, in addition to drugs determined permissible by the Board of Nursing, in a nursing home licensed by the Virginia Department of Health. Advanced medication aides shall administer drugs pursuant to this section:

1. In accordance with the prescriber's instructions pertaining to dosage, frequency, and manner of administration;

2. In accordance with regulations promulgated by the Board of Pharmacy relating to security and recordkeeping;

3. In accordance with the licensed nursing home's policies and procedures; and

4. In accordance with any other regulations promulgated by the Board of Nursing governing the practice of medication aides.

H. Verbal orders for drugs or medications shall only be given to a licensed nurse, pharmacist, or physician.

I. Drugs and medications not limited as to time or number of doses when ordered shall be automatically stopped, according to the written policies of the nursing facility, and the attending physician shall be notified.

J. Each resident's medication regimen shall be reviewed by a pharmacist licensed by the Board of Pharmacy. Any irregularities identified by the pharmacist shall be reported to the physician and the director of nursing, and their response documented.

K. Medication orders shall be reviewed at least every 60 days by the attending physician, nurse practitioner, or physician's assistant.

L. Prescription and nonprescription drugs and medications may be brought into the nursing facility by a resident's family, friend, or other person, provided:

1. The individual delivering the drugs and medications ensures timely delivery, in accordance with the nursing facility's written policies, so that the resident's prescribed treatment plan is not disrupted;

2. Each drug or medication is in an individual container; and

3. Delivery is not allowed directly to an individual resident.

In addition, prescription medications shall be obtained and labeled as required by law.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; amended, Virginia Register Volume 22, Issue 7, eff. January 11, 2006; Volume 36, Issue 23, eff. August 6, 2020; Volume 37, Issue 17, eff. May 27, 2021; Volume 42, Issue 5, eff. November 19, 2025; Volume 42, Issue 23, eff. August 13, 2026.

12VAC5-371-310 Diagnostic services

A. The nursing facility shall provide, or arrange for under written agreement, laboratory, x-ray and other diagnostic services, as ordered by a physician.

B. The nursing facility shall notify the attending physician of the results of diagnostic services.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997.

12VAC5-371-320 Dental services

A. Provisions shall be made to assist residents to obtain routine and emergency dental care.

B. Each nursing facility shall make arrangements with a qualified dental professional to provide consultation and recommend oral hygiene policies and practices for the care of residents.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; amended, Virginia Register Volume 22, Issue 7, eff. January 11, 2006.

12VAC5-371-330 Restraint usage

A. A resident shall be free from any physical or chemical restraints imposed for purposes of discipline or convenience, and not required to treat the resident's medical symptoms.

B. Restraints shall only be used:

1. In accordance with the comprehensive assessment and plan of care, which includes a schedule or plan of rehabilitation training enabling the progressive removal or the progressive use of less restrictive restraints when appropriate; and

2. As a last resort, after completing, implementing, and evaluating the resident's comprehensive assessment and plan of care, when the nursing facility has determined that less restrictive means have failed.

C. If a restraint is used in a nonemergency, the nursing facility shall:

1. Explain the use of the restraint, including potential negative outcomes of restraint use, to the resident or his legal representative, as appropriate;

2. Explain the resident's right to refuse the restraint;

3. Obtain written consent of the resident. If the resident has been legally declared incompetent, obtain written consent from the legal representative; and

4. Include the use of restraint in the plan of care.

D. Restraints shall not be ordered on a standing or PRN basis.

E. Restraints shall be applied only by staff trained in their use.

F. At a minimum, for a resident placed in a restraint, the nursing facility shall:

1. Check the resident at least every 30 minutes;

2. Provide an opportunity for motion, exercise and elimination for not less than 10 minutes each hour in which a restraint is administered; and

3. Document restraint usage, including outcomes, in accordance with nursing facility policy.

G. Emergency orders for restraints shall not be in effect for longer than 24 hours and must be confirmed by a physician within one hour of administration. Each application of emergency restraint shall be considered a single event and shall require a separate physician's order.

H. Temporary restraints may be used for a brief period to allow a medical or surgical procedure, but shall not be used to impose a medical or surgical procedure which the resident has previously refused.

I. The nursing facility shall notify a resident's legal representative, if any, or designated family member as soon as practicable, but no later than 12 hours after administration of a restraint.

J. Chemical restraint shall only be ordered in an emergency situation when necessary to ensure the physical safety of the resident or other individuals.

K. Orders for chemical restraint shall be in writing, signed by a physician, specifying the dose, frequency, duration and circumstances under which the chemical restraint is to be used. Verbal orders for chemical restraints shall be implemented when an emergency necessitates parenteral administration of psychopharmacologic drugs, but only until a written order can reasonably be obtained.

L. Emergency orders for chemical restraints shall:

1. Not be in effect for more than 24 hours; and

2. Be administered only if the resident is monitored continually for the first 15 minutes after each parenteral administration (or 30 minutes for nonparenteral administration) and every 15 minutes thereafter, for the first hour, and hourly for the next eight hours to ensure that any adverse side effects will be noticed and appropriate action taken as soon as possible.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; amended, Virginia Register Volume 37, Issue 17, eff. May 27, 2021.

Part IV Support Services

12VAC5-371-340 Dietary and food service program

A. The dietary and food service operation shall meet all applicable sections of 12VAC5-421.

B. There shall be a food protection manager, qualified as allowed in 12VAC5-421-60, responsible for the full-time management and supervision of the dietary service.

C. If the food protection manager is not a dietitian qualified according to § 54.1-2731 of the Code of Virginia, the nursing facility shall have a written agreement for ongoing consultation from a registered dietitian who meets the qualifications of § 54.1-2731 of the Code of Virginia to provide guidance to the food protection manager on methods for maintaining the dietary service, planning of nutritionally balanced meals, and assessing the dietary needs of individual residents.

D. The dietitian's duties shall include the following:

1. Developing all menus, including therapeutic diets prescribed by a resident's physician;

2. Developing, revising, and annually reviewing dietary policies, procedures and job descriptions;

3. Assisting in planning and conducting regularly scheduled inservice training that includes, but is not limited to:

a. Therapeutic diets;

b. Food preparation requirements; and

c. Principles of sanitation.

4. Visiting residents on a regular basis to discuss nutritional problems, depending upon their needs and level of care, and recommending appropriate solutions.

E. Menus shall meet the dietary allowances of the Food and Nutritional Board of the National Academy of Sciences, as adjusted for age, sex, and activity.

F. A copy of a diet manual containing acceptable practices and standards for nutrition must be kept current and on file in the dietary department.

G. Food service shall be staffed for not less than 12 hours during the day and evening. Duty schedules shall be retained for at least 30 days.

H. At least three meals, served at regular intervals, shall be provided daily to each resident, unless contraindicated as documented by the attending physician in the resident's clinical record.

I. A between meal snack of nutritional value shall be available upon request to each resident or in accordance with their plan of care.

J. Therapeutic diets shall be prepared and served as prescribed by the attending physician.

K. Visitors or employees assigned to other duties in the nursing facility shall not be allowed in the food preparation area during food preparation and resident meal service hours, except in cases of emergency.

L. Weekly menus, including therapeutic diets, substitutes, and copies of menus, as served, shall be retained on file for 12 months.

M. Disposable dinnerware or tableware shall be used only for emergencies, for infection control, as part of special activities, or as indicated in a resident's plan of care.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; amended, Virginia Register Volume 22, Issue 7, eff. January 11, 2006; Volume 26, Issue 26, eff. September 30, 2010.

12VAC5-371-350 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; repealed, Virginia Register Volume 22, Issue 7, eff. January 11, 2006.

12VAC5-371-360 Clinical records

A. The nursing facility shall maintain an organized clinical record system in accordance with recognized professional practices. Written policies and procedures shall be established specifying content and completion of clinical records.

B. Clinical records shall be confidential. Only authorized personnel shall have access as specified in §§ 8.01-413 and 32.1-127.1:03 of the Code of Virginia.

C. Records shall be safeguarded against destruction, fire, loss, or unauthorized use.

D. Overall supervisory responsibility for assuring that clinical records are maintained, completed and preserved shall be assigned to an employee of the nursing facility. The individual shall have work experience or training that is consistent with the nature and complexity of the record system and be capable of effectively carrying out the functions of the job.

E. An accurate and complete clinical record shall be maintained for each resident and shall include:

1. Resident identification;

2. Designation of attending physician;

3. Admitting information, including resident medical history, physical examination, and diagnosis;

4. Physician orders, including all medications, treatments, diets, restorative, and special medical procedures required;

5. Progress notes written at the time of each visit;

6. Documented evidence of assessment of resident's needs, establishment of an appropriate treatment plan, and interdisciplinary plan of care;

7. Nurse's notes written in chronological order and signed by the individual making the entry;

8. All symptoms and other indications of illness or injury, including date, time, and action taken on each shift;

9. Medication and treatment record, including all medications, treatments and special procedures performed;

10. Copies of radiology, laboratory and other consultant reports; and

11. Discharge summary.

F. Verbal orders shall be immediately documented in the clinical record by the individual authorized to accept the orders, and shall be countersigned.

G. Clinical records of discharged residents shall be completed within 30 days of discharge.

H. Clinical records shall be kept for a minimum of five years after discharge or death, unless otherwise specified by state or federal law.

I. Permanent information kept on each resident shall include:

1. Name;

2. Social security number;

3. Date of birth;

4. Date of admission and discharge; and

5. Name and address of legal representative, if any.

J. Clinical records shall be available to residents and legal representatives, if they wish to see them.

K. When a nursing facility closes, the owners shall make provisions for the safekeeping and confidentiality of all clinical records.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; amended, Virginia Register Volume 22, Issue 7, eff. January 11, 2006; Volume 37, Issue 17, eff. May 27, 2021.

12VAC5-371-370 Maintenance and housekeeping

A. The nursing facility shall be maintained and equipped to provide a functional, sanitary, safe, and comfortable environment.

B. A documented preventive maintenance program shall be established to ensure that equipment is operative and that the interior and exterior of the buildings are maintained in good repair and free from hazards and litter.

C. The administrator shall designate an employee responsible for carrying out these functions and for training and supervising housekeeping and maintenance personnel.

D. The heating, ventilation and air conditioning (HVAC) system shall be capable of maintaining temperatures between 70°F to 80°F throughout resident areas.

E. The nursing facility shall have an effective pest control program provided either by maintenance personnel or by contract with a pest control company.

F. The nursing facility shall provide adequate space, equipment and supplies for any special services to be offered.

G. All furniture shall be kept clean and safe for use.

H. Over bed tables shall be available as needed.

I. Stretchers and wheelchairs shall be stored out of the path of normal traffic.

J. A sufficient number of wheelchairs and chairs shall be provided for residents whose physical conditions indicate a need for such equipment.

K. Refuse containers shall be cleaned and emptied at frequent intervals.

L. Hazardous cleaning solutions, compounds and substances shall be labeled, stored and kept under lock in a safe place separate from other materials.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; amended, Virginia Register Volume 22, Issue 7, eff. January 11, 2006.

12VAC5-371-380 Laundry services

A. A quantity of linens shall be available at all times to provide for proper care and comfort of residents.

B. Linens and other laundry must be handled, stored, and processed to control the spread of infection.

C. Clean linen shall be stored in a clean and dry area accessible to the nursing unit.

D. Soiled linen shall be stored in covered containers in separate, well ventilated areas and shall not accumulate in the nursing facility.

E. Soiled linen shall not be sorted, laundered, rinsed, or stored in bathrooms, resident rooms, kitchens, or food storage areas.

F. Soiled linen shall not be placed on the floor.

G. Arrangement for laundering resident's personal clothing shall be provided. If laundry facilities are not provided on premises, commercial laundry services shall be utilized.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; amended, Virginia Register Volume 37, Issue 17, eff. May 27, 2021.

12VAC5-371-390 Transportation

A. Provisions shall be made to obtain appropriate transportation in cases of emergency.

B. The nursing facility shall assist in obtaining transportation when it is necessary to obtain medical, psychiatric, dental, diagnostic or other services outside the nursing facility.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; amended, Virginia Volume 37, Issue 17, eff. May 27, 2021.

12VAC5-371-400 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; amended, Virginia Register Volume 23, Issue 10, eff. March 1, 2007; repealed, Virginia Register Volume 37, Issue 17, eff. May 27, 2021.

Part V Physical Environment

12VAC5-371-410 Architectural drawings and specifications

A. All construction of new buildings and all additions, renovations, or alterations of existing buildings for occupancy as a nursing facility shall conform to state and local codes, zoning ordinances, and the Virginia Uniform Statewide Building Code (13VAC5-63).

In addition, nursing facilities shall be designed and constructed consistent with Parts 1 and 2 and Chapter 3.1 of Part 3 of the Guidelines for Design and Construction of Residential Health, Care, and Support Facilities, 2022 Edition (The Facility Guidelines Institute ), as amended by the August 2022 Errata for Guidelines for Design and Construction of Residential Health, Care, and Support Facilities, 2022 Edition (The Facilities Guidelines Institute).

B. Architectural drawings and specifications for all new construction or for additions, alterations, or renovations to any existing building shall be dated, stamped with professional seal, and signed by the architect. The architect shall certify that the drawings and specifications were prepared to conform to the Virginia Uniform Statewide Building Code and to be consistent with Parts 1 and 2 and Chapter 3.1 of Part 3 of the Guidelines for Design and Construction of Residential Health, Care, and Support Facilities, 2022 edition (The Facility Guidelines Institute), as amended by the August 2022 Errata for Guidelines for Design and Construction of Residential Health, Care, and Support Facilities, 2022 Edition (The Facilities Guidelines Institute).

C. Additional approval may include a Certificate of Public Need.

D. Upon completion of the construction, the nursing facility shall maintain a complete set of legible "as-built" drawings showing all construction, fixed equipment, and mechanical and electrical systems, as installed or built.

History

• Statutory Authority: §§ 32.1-12, 32.1-127, and 32.1-127.001 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; amended, Virginia Register Volume 22, Issue 7, eff. January 11, 2006; Volume 23, Issue 10, eff. March 1, 2007; Volume 26, Issue 22, eff. August 4, 2010; Volume 37, Issue 14, eff. March 31, 2021; Volume 42, Issue 23, eff. August 13, 2026.

12VAC5-371-420 Building inspection and classification

All buildings shall be inspected and approved as required by the appropriate building regulatory entity. Approval shall be a Certificate of Use and Occupancy indicating the building is classified for its proposed licensed purpose.

History

• Statutory Authority: §§ 32.1-127 and 32.1-127.001 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; amended, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC5-371-425 Additional building regulations and standards

A. Water shall be obtained from an approved water supply system. Nursing facilities shall be connected to sewage systems approved by the Department of Health or the Department of Environmental Quality.

B. Each nursing facility shall establish a monitoring program for the internal enforcement of all applicable fire and safety laws and regulations.

C. The nursing facility's food services operation shall comply with 12VAC5-421.

D. Nursing facility pharmacy services shall comply with Chapter 33 (§ 54.1-3300 et seq.) of Title 54.1 of the Code of Virginia and 18VAC110-20.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 7, eff. January 11, 2006.

12VAC5-371-430 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 13, Issue 17, eff. July 1, 1997; repealed, Virginia Register Volume 22, Issue 7, eff. January 11, 2006.

Chapter 381 Regulations for the Licensure of Home Care Organizations

Part I Definitions and General Information

12VAC5-381-10 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Activities of daily living" or "ADLs" means bathing, dressing, toileting, transferring, bowel control, bladder control and eating/feeding. A person's degree of independence in performing these activities is part of determining the appropriate level of care and services. A need for assistance exists when the client is unable to complete an activity due to cognitive impairment, functional disability, physical health problems, or safety. The client's functional level is based on the client's need for assistance most or all of the time to perform personal care tasks in order to live independently.

"Administer" means the direct application of a controlled substance, whether by injection, inhalation, ingestion or any other means, to the body of a client by (i) a practitioner or by his authorized agent and under his direction or (ii) the client at the direction and in the presence of the practitioner as defined in § 54.1-3401 of the Code of Virginia.

"Administrator" means a person designated in writing by the governing body as having the necessary authority for the day-to-day management of the organization. The administrator must be an employee of the organization. The administrator, the director of nursing, or other clinical director may be the same individual if that individual is dually qualified.

"Available at all times during operating hours" means an individual is readily available on the premises or by telecommunications.

"Barrier crimes" means certain offenses, specified in § 32.1-162.9:1 of the Code of Virginia, that automatically bar an individual convicted of those offenses from employment with a home care organization.

"Blanket fidelity bond" means a bond that provides coverage that protects an organization's losses as a result of employee theft or fraud.

"Branch office" means a geographically separate office of the home care organization that performs all or part of the primary functions of the home care organization on a smaller scale.

"Chore services" means assistance with nonroutine, heavy home maintenance for persons unable to perform such tasks. Chore services include minor repair work on furniture and appliances; carrying coal, wood and water; chopping wood; removing snow; yard maintenance; and painting.

"Client record" means the centralized location for documenting information about the client and the care and services provided to the client by the organization. A client record is a continuous and accurate account of care or services, whether hard copy or electronic, provided to a client, including information that has been dated and signed by the individuals who prescribed or delivered the care or service.

"Client's residence" means the place where the individual or client makes his home such as his own apartment or house, a relative's home or an assisted living facility, but does not include a hospital, nursing facility or other extended care facility.

"Commissioner" means the State Health Commissioner.

"Companion services" means assisting persons unable to care for themselves without assistance. Companion services include transportation, meal preparation, shopping, light housekeeping, companionship, and household management.

"Contract services" means services provided through agreement with another agency, organization, or individual on behalf of the organization. The agreement specifies the services or personnel to be provided on behalf of the organization and the fees to provide these services or personnel.

"Criminal record report" means the statement issued by the Central Criminal Record Exchange, Virginia Department of State Police.

"Department" means the Virginia Department of Health.

"Discharge or termination summary" means a final written summary filed in a closed client record of the service delivered, goals achieved and final disposition at the time of client's discharge or termination from service.

"Dispense" means to deliver a drug to an ultimate user by or pursuant to the lawful order of a practitioner, including the prescribing and administering, packaging, labeling or compounding necessary to prepare the substance for that delivery.

"Drop site" means a location that HCO staff use in the performance of daily tasks such as obtaining supplies, using fax and copy machines, charting notes on care or services provided, and storing client records. These locations may also be called charting stations, workstations, or convenience sites.

"Employee" means an individual who has the status of an employee as defined by the U.S. Internal Revenue Service.

"Functional limitations" means the level of a client's need for assistance based on an assessment conducted by the supervising nurse. There are three criteria to assessing functional status: (i) the client's impairment level and need for personal assistance, (ii) the client's lack of capacity, and (iii) how the client usually performed the activity over a period of time. If a person is mentally and physically free of impairment, there is not a safety risk to the individual, or the person chooses not to complete an activity due to personal preference or choice, then that person does not need assistance.

"Governing body" means the individual, group or governmental agency that has legal responsibility and authority over the operation of the home care organization.

"Home attendant" means a nonlicensed individual performing skilled, pharmaceutical and personal care services, under the supervision of the appropriate health professional, to a client in the client's residence. Home attendants are also known as certified nurse aides or CNAs, home care aides, home health aides, or personal care aides.

"Home care organization" or "HCO" means a public or private entity providing an organized program of home health, pharmaceutical or personal care services, according to § 32.1-162.1 of the Code of Virginia in the residence of a client or individual to maintain the client's health and safety in his home. A home care organization does not include any family members, relatives or friends providing caregiving services to persons who need assistance to remain independent and in their own homes.

"Home health agency" means a public or private agency or organization, or part of an agency or organization, that meets the requirements for participation in Medicare under 42 CFR 440.70 (d), by providing skilled nursing services and at least one other therapeutic service, for example, physical, speech, or occupational therapy; medical social services; or home health aide services, and also meets the capitalization requirements under 42 CFR 489.28.

"Homemaker services" means assistance to persons with the inability to perform one or more instrumental activities of daily living. Homemaker services may also include assistance with bathing areas the client cannot reach, fastening client's clothing, combing hair, brushing dentures, shaving with an electric razor, and providing stabilization to a client while walking. Homemaker services do not include feeding, bed baths, transferring, lifting, putting on braces or other supports, cutting nails or shaving with a blade.

"Infusion therapy" means the procedures or processes that involve the administration of injectable medications to clients via the intravenous, subcutaneous, epidural, or intrathecal routes. Infusion therapy does not include oral, enteral, or topical medications.

"Instrumental activities of daily living" means meal preparation, housekeeping/light housework, shopping for personal items, laundry, or using the telephone. A client's degree of independence in performing these activities is part of determining the appropriate level of care and services.

"Licensed practical nurse" means a person who holds a current license issued by the Virginia Board of Nursing or a current multistate licensure privilege to practice nursing in Virginia as a licensed practical nurse.

"Licensee" means a licensed home care provider.

"Medical plan of care" means a written plan of services, and items needed to treat a client's medical condition, that is prescribed, signed and periodically reviewed by the client's primary care physician.

"Nursing services" means client care services, including, but not limited to, the curative, restorative, or preventive aspects of nursing that are performed or supervised by a registered nurse according to a medical plan of care.

"OLC" means the Office of Licensure and Certification of the Virginia Department of Health.

"Operator" means any individual, partnership, association, trust, corporation, municipality, county, local government agency or any other legal or commercial entity that is responsible for the day-to-day administrative management and operation of the organization.

"Organization" means a home care organization.

"Person" means any individual, partnership, association, trust, corporation, municipality, county, local government agency or any other legal or commercial entity that operates a home care organization.

"Personal care services" means the provision of nonskilled services, including assistance in the activities of daily living, and may include instrumental activities of daily living, related to the needs of the client, who has or is at risk of an illness, injury or disabling condition. A need for assistance exists when the client is unable to complete an activity due to cognitive impairment, functional disability, physical health problems, or safety. The client's functional level is based on the client's need for assistance most or all of the time to perform the tasks of daily living in order to live independently.

"Primary care physician" means a physician licensed in Virginia, according to Chapter 29 (§ 54.1-2900 et seq.) of Title 54.1 of the Code of Virginia, or licensed in an adjacent state and identified by the client as having the primary responsibility in determining the delivery of the client's medical care. The responsibility of physicians contained in this chapter may be implemented by nurse practitioners or physician assistants as assigned by the supervising physician and within the parameters of professional licensing.

"Qualified" means meeting current legal requirements of licensure, registration or certification in Virginia or having appropriate training, including competency testing, and experience commensurate with assigned responsibilities.

"Quality improvement" means ongoing activities designed to objectively and systematically evaluate the quality of client care and services, pursue opportunities to improve client care and services, and resolve identified problems. Quality improvement is an approach to the ongoing study and improvement of the processes of providing health care services to meet the needs of clients and others.

"Registered nurse" means a person who holds a current license issued by the Virginia Board of Nursing or a current multistate licensure privilege to practice nursing in Virginia as a registered nurse.

"Service area" means a clearly delineated geographic area in which the organization arranges for the provision of home care services, personal care services, or pharmaceutical services to be available and readily accessible to persons.

"Skilled services" means the provision of the home health services listed in 12VAC5-381-300.

"Supervision" means the ongoing process of monitoring the skills, competencies and performance of the individual supervised and providing regular, documented, face-to-face guidance and instruction.

"Sworn disclosure statement" means a document disclosing an applicant's criminal convictions and pending criminal charges occurring in Virginia or any other state.

"Third-party crime insurance" means insurance coverage that protects an organization's losses as a result of employee theft or fraud.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008; Volume 31, Issue 10, eff. February 12, 2015.

12VAC5-381-20 License

A. A license to operate a home care organization is issued to a person. However, no license shall be issued to a person who has been sanctioned pursuant to 42 USC § 1320a-7b. Persons planning to seek federal certification or national accreditation pursuant to § 32.1-162.8 of the Code of Virginia must first obtain state licensure.

B. The commissioner shall issue or renew a license to establish or operate a home care organization if the commissioner finds that the home care organization is in compliance with the law and this regulation.

C. The commissioner may issue a license to a home care organization authorizing the licensee to provide services at one or more branch offices serving portions of the total geographic area served by the licensee, provided each branch office operates under the supervision and administrative control of the licensee. The address of each branch office at which services are provided by the licensee shall be included on any license issued to the licensee.

D. Every home care organization shall be designated by an appropriate name. The name shall not be changed without first notifying the OLC.

E. Licenses shall not be transferred or assigned.

F. Any person establishing, conducting, maintaining, or operating a home care organization without a license shall be guilty of a Class 6 felony according to § 32.1-162.15 of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008; Volume 29, Issue 8, eff. January 17, 2013; Volume 31, Issue 10, eff. February 12, 2015.

12VAC5-381-30 Exemption from licensure

A. This chapter is not applicable to those individuals and home care organizations listed in § 32.1-162.8 of the Code of Virginia. Organizations planning to seek federal certification as a home health agency or national accreditation must first obtain state licensure and provide services to clients before applying for national accreditation or federal certification.

In addition, this chapter is not applicable to those providers of only homemaker, chore or companion services as defined in 12VAC5-381-10.

B. A licensed organization requesting exemption must file a written request and pay the required fee stated in 12VAC5-381-70 D.

C. The home care organization shall be notified in writing if the exemption from licensure has been granted. The basis for the exemption approval will be stated and the organization will be advised to contact the OLC to request licensure should it no longer meet the requirement for exemption.

D. Exempted organizations are subject to complaint investigations in keeping with state law.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008.

12VAC5-381-40 License application; initial and renewal

A. The OLC provides prelicensure consultation and technical assistance regarding the licensure process. The purpose of such consultation is to explain the regulation and the survey process. Prelicensure consultations are arranged after a completed initial application is on file with the OLC.

B. Licensure applications are obtained from the OLC. The OLC shall consider an application complete when all requested information and the appropriate fee, stated in 12VAC5-381-70, is submitted. If the OLC finds the application incomplete, the applicant will be notified in writing.

C. The activities and services of each applicant and licensee shall be subject to an inspection by the OLC to determine if the organization is in compliance with the provisions of this chapter and state law.

D. A completed application for initial licensure must be submitted at least 60 days prior to the organization's planned opening date to allow the OLC time to process the application. An incomplete application shall become inactive six months after it is received by the OLC. Applicants must then reapply for licensure with a completed application and application fee. An application for a license may be withdrawn at any time.

E. Licenses are renewed triennially. The OLC shall make renewal applications available at least 60 days prior to the expiration date of the current license.

F. It is the home care organization's responsibility to complete and return a renewal application to ensure timely processing. Should a current license expire before a new license is issued, the current license shall remain in effect, provided a complete and accurate application was filed on time.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008; Volume 41, Issue 17, eff. May 22, 2025.

12VAC5-381-50 Compliance appropriate for all types of HCOs

All organizations shall be in compliance with Part I (12VAC5-381-10 et seq.) and Part II (12VAC5-381-150 et seq.) of this chapter. In addition, organizations shall be in compliance with Part III (12VAC5-381-300 et seq.), Part IV (12VAC5-381-350), or Part V (12VAC5-381-360 et seq.) of this chapter as applicable to the services provided by the organization.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-381-60 Changes to or reissue of a license

A. It is the responsibility of the organization's governing body to maintain a current and accurate license. Licenses that are misplaced or lost must be replaced.

B. An organization shall give written notification 30 working days in advance of any proposed changes that may require the reissuance of a license. Notices shall be sent to the attention of the director of the OLC.

The following changes require the reissuance of a license and payment of a fee:

1. Operator;

2. Organization name; or

3. Address.

C. The OLC will evaluate written information about any planned changes in operation that affect the terms of the license or the continuing eligibility for a license. A licensing representative may inspect the organization during the process of evaluating a proposed change.

D. The organization will be notified in writing whether a new application is needed.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008.

12VAC5-381-70 Fees

A. The OLC shall collect a fee of $1,500 for each initial and renewal license application. Fees shall accompany the licensure application and are not refundable.

B. An additional late fee of $50 shall be collected for an organization's failure to file a renewal application by the date specified.

C. A processing fee of $250 shall be collected for each reissuance or replacement of a license and shall accompany the application for reissuance or replacement.

D. A one-time processing fee of $75 for exemption from licensure shall accompany the exemption application.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008; Volume 41, Issue 17, eff. May 22, 2025.

12VAC5-381-80 On-site inspections

A. An OLC representative shall make periodic unannounced on-site inspections of each home care organization as necessary but not less often than biennially. The organization shall be responsible for correcting any deficiencies found during any on-site inspection. Compliance with all standards will be determined by the OLC according to applicable law.

B. The home care organization shall make available to the OLC's representative any necessary records and shall allow access to interview the agents, employees, contractors, and any person under the organization's control, direction or supervision.

C. After the on-site inspection, the OLC's representative shall discuss the findings of the inspection with the administrator or his designee.

D. The administrator shall submit, within 15 working days of receipt of the inspection report, an acceptable plan for correcting any deficiencies found. The plan of correction shall contain:

1. A description of the corrective action or actions to be taken and the personnel to implement the corrective action;

2. The expected correction date;

3. A description of the measures implemented to prevent a recurrence of the violation; and

4. The signature of the person responsible for the validity of the report.

E. The administrator will be notified whenever any item in the plan of correction is determined to be unacceptable.

F. The administrator shall be responsible for assuring the plan of correction is implemented and monitored so that compliance is maintained.

G. Completion of corrective actions shall not exceed 45 working days from the last day of the inspection.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008.

12VAC5-381-90 Home visits

A. As part of any inspection, an OLC representative may conduct home visits.

B. The home care organization shall be responsible for arranging in-home visits with clients, family members, and caregivers for the OLC representative.

C. The organization shall explain clearly to the client, family or caretaker that the permission for the representative's home visit is voluntary and that consent to the home visit will not affect the client's care or other health benefits.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008.

12VAC5-381-100 Complaint investigations conducted by the OLC

A. The OLC has the responsibility to investigate any complaints regarding alleged violations of this chapter and applicable law.

B. Complaints may be received in writing or orally and may be anonymous.

C. When the investigation is complete, the licensee and the complainant, if known, will be notified of the findings of the investigation.

D. As applicable, the administrator shall submit, within 15 working days of receipt of the complaint report, an acceptable plan of correction for any deficiencies found during a complaint investigation. The plan of correction shall contain:

1. A description of the corrective action or actions to be taken and the personnel to implement the corrective action;

2. The expected correction date;

3. A description of the measures implemented to prevent a recurrence of the violation; and

4. The signature of the person responsible for the validity of the report.

E. The administrator will be notified in writing whenever any item in the plan of correction is determined to be unacceptable.

F. The administrator shall be responsible for assuring the plan of correction is implemented and monitored so that compliance is maintained.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008.

12VAC5-381-110 Criminal records checks

A. Section 32.1-162.9:1 of the Code of Virginia requires home care providers, as defined in § 32.1-162.7 of the Code of Virginia, to obtain a criminal record report on applicants for compensated employment from the Virginia Department of State Police. Section 32.1-162.9:1 of the Code of Virginia also requires that all applicants for employment in home care organizations provide a sworn disclosure statement regarding their criminal history.

B. The criminal record report shall be obtained within 30 days of employment. It shall be the responsibility of the organization to ensure that its employees have not been convicted of any of the barrier crimes listed in § 32.1-162.9:1 of the Code of Virginia.

C. The organization shall not accept a criminal record report dated more than 90 days prior to the date of employment.

D. Only the original criminal record report shall be accepted. An exception is permitted for organizations using temporary staffing agencies for the provision of substitute staff. The organization shall obtain a letter from the temporary staffing agency containing the following information:

1. The name of the substitute staffing person;

2. The date of employment by the temporary staffing agency; and

3. A statement verifying that the criminal record report has been obtained within 30 days of employment, is on file at the temporary staffing agency, and does not contain any barrier crimes listed in § 32.1-162.9:1 of the Code of Virginia.

E. No employee shall be permitted to work in a position that involves direct contact with a patient until an original criminal record report has been received by the home care organization or temporary staffing agency, unless such person works under the direct supervision of another employee for whom a background check has been completed in accordance with subsection B of this section.

F. A criminal record report remains valid as long as the employee remains in continuous service with the same organization.

G. A new criminal record report and sworn statement shall be required when an individual terminates employment at one home care organization and begins work at another home care organization. The following exceptions are permitted:

1. When an employee transfers within 30 days to an organization owned and operated by the same entity. The employee's file shall contain a statement that the original criminal record report has been transferred or forwarded to the new work location.

2. When an individual takes a leave of absence, the criminal record report and sworn statement will remain valid as long as the period of separation does not exceed six consecutive months. If six consecutive months have passed, a new criminal record report and sworn disclosure statement are required.

H. A sworn disclosure statement shall be completed by all applicants for employment. The sworn disclosure statement shall be attached to and filed with the criminal record report.

I. Any applicant denied employment because of convictions appearing on his criminal record report shall be provided a copy of the report by the hiring organization.

J. All criminal record reports shall be confidential and maintained in locked files accessible only to the administrator or designee.

K. Further dissemination of the criminal record report and sworn disclosure statement information is prohibited other than to the commissioner's representative or a federal or state authority or court as may be required to comply with an express requirement of law for such further dissemination.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 31, Issue 10, eff. February 12, 2015.

12VAC5-381-120 Variances

A. The OLC can authorize variances only to its own licensing regulations, not to regulations of another agency or to any requirements in federal, state, or local laws.

B. A home care organization may request a variance to a particular regulation or requirement contained in this chapter when the standard or requirement poses a special hardship and when a variance to it would not endanger the safety or well-being of clients. The request for a variance must describe how compliance with the current regulation is economically burdensome and constitutes a special hardship to the home care organization and to the clients it serves. When applicable, the request should include proposed alternatives to meet the purpose of the requirements that will ensure the protection and well-being of clients. At no time shall a variance approved for one individual be extended to general applicability. The home care organization may at any time withdraw a request for a variance.

C. The OLC shall have the authority to waive, either temporarily or permanently, the enforcement of one or more of these regulations provided safety, client care and services are not adversely affected.

D. The OLC may rescind or modify a variance if (i) conditions change; (ii) additional information becomes known that alters the basis for the original decision; (iii) the organization fails to meet any conditions attached to the variance; or (iv) results of the variance jeopardize the safety, comfort, or well-being of clients.

E. Consideration of a variance is initiated when a written request is submitted to the Director, OLC. The OLC shall notify the home care organization in writing of the receipt of the request for a variance. The OLC may attach conditions to a variance to protect the safety and well-being of the client.

F. The licensee shall be notified in writing if the requested variance is denied.

G. If a variance is denied, expires, or is rescinded, routine enforcement of the regulation or portion of the regulation shall be resumed.

H. The home care organization shall develop procedures for monitoring the implementation of any approved variances to assure the ongoing collection of any data relevant to the variance and the presentation of any later report concerning the variance as requested by the OLC.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; Errata, 22:4 VA.R. 659 October 31, 2005; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008.

12VAC5-381-130 Revocation or suspension of a license

A. The commissioner is authorized to revoke or suspend any license if the licensee fails to comply with the provisions of Article 7.1 (§ 32.1-162.7 et seq.) of Chapter 5 of Title 32.1 of the Code of Virginia or the regulations of the board.

B. If a license is revoked, the commissioner may issue a new license when the conditions upon which revocation was based have been corrected and compliance with all provisions of the law and this chapter has been achieved.

C. When a license is revoked or suspended, the organization shall cease operations. If the organization continues to operate after its license has been revoked or suspended, the commissioner may request the Office of the Attorney General to petition the circuit court of the jurisdiction in which the home care organization is located for an injunction to cause such home care organization to cease operations.

D. Suspension of a license shall in all cases be for an indefinite time. The suspension may be lifted and rights under the license fully or partially restored at such time as the commissioner determines that the rights of the licensee appear to so require and the interests of the public will not be jeopardized by resumption of operation.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-381-140 Return of a license

A. Circumstances under which a license must be returned include, but are not limited to (i) transfer of ownership and (ii) discontinuation of services.

B. The licensee shall notify its clients and the OLC, in writing, 30 days before discontinuing services.

C. If the organization is no longer operational, or the license has been suspended or revoked, the license shall be returned to the OLC within five working days. The licensee shall notify its clients and the OLC where all home care records will be located.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008.

Part II Administrative Services

12VAC5-381-150 Management and administration

A. No person shall establish or operate a home care organization, as defined in § 32.1-162.7 of the Code of Virginia, without having obtained a license.

B. The organization must comply with:

1. This chapter (12VAC5-381);

2. Other applicable federal, state or local laws and regulations; and

3. The organization's own policies and procedures.

C. The organization shall submit or make available reports and information necessary to establish compliance with this chapter and applicable law.

D. The organization shall permit representatives from the OLC to conduct inspections to:

1. Verify application information;

2. Determine compliance with this chapter;

3. Review necessary records and documents; and

4. Investigate complaints.

E. The organization shall notify the OLC 30 days in advance of changes affecting the organization, including the:

1. Service area;

2. Mailing address of the organization;

3. Ownership;

4. Services provided;

5. Operator;

6. Administrator;

7. Organization name; and

8. Closure of the organization.

F. The current license from the department shall be posted for public inspection.

G. Service providers or community affiliates under contract with the organization must comply with the organization's policies and this chapter.

H. The organization shall not use any advertising that contains false, misleading or deceptive statements or claims, or false or misleading disclosures of fees and payment for services.

I. The organization shall have regular posted business hours and be fully operational during such business hours. In addition, the organization shall provide or arrange for services to their clients on an on-call basis 24 hours a day, seven days a week.

J. The organization shall accept a client only when the organization can adequately meet that client's needs in the client's place of residence.

K. The organization must have a prepared plan for emergency operations in case of inclement weather or natural disaster to include contacting and providing essential care to clients, coordinating with community agencies to assist as needed, and maintaining a current list of clients who would require specialized assistance.

L. The organization shall encourage and facilitate the availability of flu shots for its staff and clients.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008.

12VAC5-381-160 Governing body

A. The organization shall have a governing body that is legally responsible for the management, operation and fiscal affairs of the organization. The governing body of a hospital that operates a home care organization shall include in its internal organization structure an identified unit of home care services.

B. The governing body shall:

1. Determine which services are to be provided by the organization;

2. Ensure that the organization is staffed and adequately equipped to provide the services it offers to clients, whether provided directly by the organization or through contract;

3. Comply with federal and state laws, regulations and local ordinances governing operations of the organization; and

4. Establish a quality improvement committee.

C. The governing body shall review annually and approve the written policies and procedures of the organization.

D. The governing body shall review annually and approve the recommendations of the quality improvement committee, when appropriate.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-381-170 Administrator

A. The governing body shall appoint as administrator an individual who has evidence of at least one year of training and experience in direct health care service delivery with at least one year within the last five years of supervisory or administrative management experience in home health care or a related health program.

B. The administrator shall be responsible for the day-to-day management of the organization, including but not limited to:

1. Organizing and supervising the administrative function of the organization;

2. Maintaining an ongoing liaison with the governing body, the professional personnel and staff;

3. Employing qualified personnel and ensuring adequate staff orientation, training, education and evaluation;

4. Ensuring the accuracy of public information materials and activities;

5. Implementing an effective budgeting and accounting system;

6. Maintaining compliance with applicable laws and regulations and implementing corrective action in response to reports of organization committees and regulatory agencies;

7. Arranging and negotiating services provided through contractual agreement; and

8. Implementing the policies and procedures approved by the governing body.

C. The individual designated to perform the duties of the administrator when the administrator is absent from the organization shall be able to perform the duties of the administrator as identified in subsection B of this section.

D. The administrator or his designee shall be available at all times during operating hours and for emergency situations.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 26, Issue 26, eff. September 30, 2010.

12VAC5-381-180 Written policies and procedures

A. The organization shall implement written policies and procedures approved by the governing body.

B. All policies and procedures shall be reviewed at least annually, with recommended changes submitted to the governing body for approval, as necessary.

C. Administrative and operational policies and procedures shall include, but are not limited to:

1. Administrative records;

2. Admission and discharge or termination from service criteria;

3. Informed consent;

4. Advance directives, including Durable Do Not Resuscitate Orders;

5. Client rights;

6. Contract services;

7. Medication management, if applicable;

8. Quality improvement;

9. Mandated reporting of abuse, neglect and exploitation pursuant to § 63.2-1606 of the Code of Virginia;

10. Communicable and reportable diseases;

11. Client records, including confidentiality;

12. Record retention, including termination of services;

13. Supervision and delivery of services;

14. Emergency and on-call services;

15. Infection control;

16. Handling consumer complaints;

17. Telemonitoring; and

18. Approved variances.

D. Financial policies and procedures shall include, but are not limited to:

1. Admission agreements;

2. Data collection and verification of services delivered;

3. Methods of billing for services by the organization and by contractors;

4. Client notification of changes in fees and charges;

5. Correction of billing errors and refund policy; and

6. Collection of delinquent client accounts.

E. Personnel policies and procedures shall include, but are not limited to a:

1. Written job description that specifies authority, responsibility, and qualifications for each job classification;

2. Process for maintaining an accurate, complete and current personnel record for each employee;

3. Process for verifying current professional licensing or certification and training of employees or independent contractors;

4. Process for annually evaluating employee performance and competency;

5. Process for verifying that contractors and their employees meet the personnel qualifications of the organization;

6. Process for obtaining a criminal background check and maintaining a drug-free workplace pursuant to § 32.1-162.9:1 of the Code of Virginia; and

7. Process for reporting licensed and certified medical personnel for violations of their licensing or certification to the appropriate board within the Department of Health Professions.

F. Admission and discharge or termination from service policies and procedures shall include, but are not limited to:

1. Criteria for accepting clients for services offered;

2. The process for obtaining a plan of care or service;

3. Criteria for determining discharge or termination from each service and referral to other agencies or community services; and

4. Process for notifying clients of intent to discharge/terminate or refer, including:

a. Oral and written notice and explanation of the reason for discharge/termination or referral;

b. The name, address, telephone number and contact name at the referral organization; and

c. Documentation in the client record of the referral or notice.

G. Policies shall be made available for review, upon request, to clients and their designated representatives.

H. Policies and procedures shall be readily available for staff use at all times.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 26, Issue 26, eff. September 30, 2010.

12VAC5-381-190 Financial controls

A. Every applicant for an initial license to establish or operate a home care organization shall include as part of his application a detailed operating budget showing projected operating expenses for the three-month period after a license to operate has been issued. Further, every applicant for an initial license to establish or operate a home care organization shall include as part of his application proof of initial reserve operating funds in the amount sufficient to ensure operation of the home care organization for the three-month period after a license to operate has been issued. Such funds may include:

1. Cash;

2. Cash equivalents that are readily convertible to known amounts of cash and that present insignificant risk of change in value;

3. Borrowed funds that are immediately available to the applicant; or

4. A line of credit that is immediately available to the applicant.

Proof of funds sufficient to meet these requirements shall include a current balance sheet demonstrating the availability of funds, a letter from the officer of the bank or other financial institution where the funds are held, or a letter of credit from a lender demonstrating the current availability of and amount of a line of credit.

B. The organization shall document financial resources to operate based on a working budget showing projected revenue and expenses.

C. All financial records shall be kept according to generally accepted accounting principles (GAAP).

D. All financial records shall be audited at least triennially by an independent certified public accountant (CPA) or audited as otherwise provided by law.

E. The organization shall have documented financial controls to minimize risk of theft or embezzlement.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 31, Issue 10, eff. February 12, 2015.

12VAC5-381-200 Personnel practices

A. Personnel management and employment practices shall comply with applicable state and federal laws and regulations.

B. The organization shall design and implement a staffing plan that reflects the types of services offered and shall provide qualified staff in sufficient numbers to meet the assessed needs of all clients.

C. Employees and contractors shall be licensed or certified as required by the Department of Health Professions.

D. The organization shall design and implement a mechanism to verify professional credentials.

E. Any person who assumes the responsibilities of any staff position or positions shall meet the minimum qualifications for that position or positions.

F. The organization shall obtain the required sworn statement and criminal record check for each compensated employee as specified in § 32.1-162.9:1 of the Code of Virginia.

G. Each employee position shall have a written job description that includes:

1. Job title;

2. Duties and responsibilities required of the position;

3. Job title of the immediate supervisor; and

4. Minimum knowledge, skills, and abilities or professional qualifications required for entry level.

H. Employees shall have access to their current position description. There shall be a mechanism for advising employees of changes to their job responsibilities.

I. New employees and contract individuals shall be oriented commensurate with their function or job-specific responsibilities. Orientation shall include:

1. Objectives and philosophy of the organization;

2. Confidentiality;

3. Client rights;

4. Mandated reporting of abuse, neglect, and exploitation;

5. Applicable personnel policies;

6. Emergency preparedness procedures;

7. Infection control practices and measures;

8. Cultural awareness; and

9. Applicable laws, regulations, and other policies and procedures that apply to specific positions, specific duties and responsibilities.

J. The organization shall develop and implement a policy for evaluating employee performance.

K. Individual staff development needs and plans shall be a part of the performance evaluation.

L. The organization shall provide opportunities for and record participation in staff development activities designed to enable staff to perform the responsibilities of their positions.

M. All individuals who enter a client's home for or on behalf of the organization shall be readily identifiable by employee nametag, uniform or other visible means.

N. The organization shall maintain an organized system to manage and protect the confidentiality of personnel files and records.

O. Employee personnel records, whether hard copy or electronic, shall include:

1. Identifying information;

2. Education and training history;

3. Employment history;

4. Results of the verification of applicable professional licenses or certificates;

5. Results of reasonable efforts to secure job-related references and reasonable verification of employment history;

6. Results of performance evaluations;

7. A record of disciplinary actions taken by the organization, if any;

8. A record of adverse action by any licensing bodies and organizations, if any;

9. A record of participation in staff development activities, including orientation; and

10. The criminal record check and sworn affidavit.

P. All positive results from drug testing shall be reported to the health regulatory boards responsible for licensing, certifying, or registering the person to practice, if any, pursuant to § 32.1-162.9:1 of the Code of Virginia.

Q. Each employee personnel record shall be retained in its entirety for a minimum of three years after termination of employment.

R. Personnel record information shall be safeguarded against loss and unauthorized use.

S. Employee health-related information shall be maintained separately within the employee's personnel file.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 26, Issue 26, eff. September 30, 2010.

12VAC5-381-210 Indemnity coverage

A. The governing body shall ensure the organization and its contractors have appropriate indemnity coverage to compensate clients for injuries and losses resulting from services provided.

B. The organization shall purchase and maintain the following types and minimum amounts of indemnity coverage at all times:

1. Malpractice insurance consistent with § 8.01-581.15 of the Code of Virginia;

2. General liability insurance covering personal property damages, bodily injuries, product liability, and libel and slander of at least $1 million comprehensive general liability per occurrence; and

3. Third-party crime insurance or a blanket fidelity bond of $50,000 minimum.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 31, Issue 10, eff. February 12, 2015.

12VAC5-381-220 Contract services

A. There shall be a written agreement for the provision of services not provided by employees of the organization.

B. The written agreement shall include, but is not limited to:

1. The services to be furnished by each party to the contract;

2. The contractor's responsibility for participating in developing plans of care or service;

3. The manner in which services will be controlled, coordinated, and evaluated by the primary home care organization;

4. The procedures for submitting notes on the care or services provided, scheduling of visits, and periodic client evaluation;

5. The process for payment for services furnished under the contract; and

6. Adequate liability insurance and third-party crime insurance or a blanket fidelity bond.

C. The organization shall have a written plan for provision of care or services when a contractor is unable to deliver services.

D. The contractor shall conform to applicable organizational policies and procedures as specified in the contract, including the required sworn disclosure statement and criminal record check.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 31, Issue 10, eff. February 12, 2015.

12VAC5-381-230 Client rights

A. The organization shall establish and implement written policies and procedures regarding the rights of clients.

B. Client rights shall be reviewed with clients or client designees upon admission to the organization. The review shall be documented in the client's record.

C. Written procedures to implement the policies shall ensure that each client is:

1. Treated with courtesy, consideration and respect and is assured the right of privacy;

2. Assured confidential treatment of his medical and financial records as provided by law;

3. Free from mental and physical abuse, neglect, and property exploitation;

4. Assured the right to participate in the planning of the client's home care, including the right to refuse services;

5. Served by individuals who are properly trained and competent to perform their duties;

6. Assured the right to voice grievances and complaints related to organizational services without fear of reprisal;

7. Advised, before care is initiated, of the extent to which payment for the home care organization services may be expected from federal or state programs, and the extent to which payment may be required from the client;

8. Advised orally and in writing of any changes in fees for services that are the client's responsibility. The home care organization shall advise the client of these changes as soon as possible, but no later than 30 calendar days from the date the home care organization became aware of the change;

9. Provided with advance directive information prior to start of services; and

10. Given at least five days written notice when the organization determines to terminate services.

D. Before care is initiated, the home care organization shall inform the client, orally and in writing, of:

1. The nature and frequency of services to be delivered and the purpose of the service;

2. Any anticipated effects of treatment, as applicable:

3. A schedule of fees and charges for services;

4. The method of billing and payment for services, including the:

a. Services to be billed to third party payers;

b. Extent to which payment may be expected from third party payers known to the home care organization; and

c. Charges for services that will not be covered by third party payers;

5. The charges that the individual may have to pay;

6. The requirements of notice for cancellation or reduction in services by the organization and the client; and

7. The refund policies of the organization.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-381-240 Handling complaints received from clients

A. The organization shall establish and maintain complaint handling procedures that specify the:

1. System for logging receipt, investigation and resolution of complaints; and

2. Format of the written record of the findings of each complaint investigated.

B. The organization shall designate staff responsible for complaint resolution, including:

1. Complaint intake, including acknowledgment of complaints;

2. Investigation of the complaint;

3. Review of the investigation of findings and resolution for the complaint; and

4. Notification to the complainant of the proposed resolution within 30 days from the date of receipt of the complaint.

C. The client or his designee shall be given a copy of the complaint procedures at the time of admission to service. The organization shall provide each client or his designee with the name, mailing address, and telephone number of the:

1. Organization contact person;

2. State Ombudsman; and

3. Complaint Unit of the OLC.

D. The organization shall maintain documentation of all complaints received and the status of each complaint from date of receipt through its final resolution. Records shall be maintained from the date of last inspection and for no less than three years.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008.

12VAC5-381-250 Quality improvement

A. The organization shall implement an ongoing, comprehensive, integrated, self-assessment program of the quality and appropriateness of care or services provided, including services provided under contract or agreement. The findings shall be used to correct identified problems and revise policies and practices, as necessary. Exclusive concentration on administrative or cost-of-care issues does not fulfill this requirement.

B. The following data shall be evaluated to identify unacceptable or unexpected trends or occurrences:

1. Staffing patterns and performance to assure adequacy and appropriateness of services delivered;

2. Supervision appropriate to the level of service;

3. On-call responses;

4. Client records for appropriateness of services provided;

5. Client satisfaction;

6. Complaint resolution;

7. Infections;

8. Staff concerns regarding client care; and

9. Provision of services appropriate to the clients' needs.

C. A quality improvement committee responsible for the oversight and supervision of the program, shall consist of:

1. The director of skilled services or organization's register nurse as appropriate for the type of services provided;

2. A member of the administrative staff;

3. Representatives from each of the services provided by the organization, including contracted services; and

4. An individual with demonstrated ability to represent the rights and concerns of clients. The individual may be a member of the organization's staff, a client, or a client's family member.

In selecting members of this committee, consideration shall be given to a candidate's abilities and sensitivity to issues relating to quality of care and services provided to clients.

D. Measures shall be implemented to resolve important problems or concerns that have been identified. Health care practitioners, as applicable, and administrative staff shall participate in the resolution of the problems or concerns that are identified.

E. Results of the quality improvement program shall be reported annually to the governing body and the administrator and available in the organization. The report shall be acted upon by the governing body and the organization. All corrective actions shall be documented.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-381-260 Infection control

A. The organization shall implement a program to reduce the risk of infection.

B. Infection control activities shall include, but are not limited to:

1. Staff education regarding infection risk-reduction behaviors;

2. Use of universal precautions;

3. Handling, storing, processing and transporting of regulated medical waste according to applicable procedures;

4. Handling, storing, processing and transporting supplies and equipment in a manner that prevents the spread of infections; and

5. Monitoring staff performance in infection control practices.

C. Accumulated waste, including all contaminated sharps, dressings, or similar infectious waste, shall be disposed of in a manner compliant with the OSHA Bloodborne Pathogens standard (29 CFR 1910.1030).

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-381-270 Drop sites

A. The organization may operate one or more drop sites for the convenience of staff providing direct client care or service. However, such sites shall not:

1. Have staff assigned;

2. Accept referrals; or

3. Be advertised as part of the organization.

B. Any client records located at the site shall be safeguarded against loss or unauthorized use. Only authorized personnel shall have access to client records as specified by state and federal law. It shall be the responsibility of the organization to assure that records maintained at the site are readily available for inspection staff.

C. Operation of a drop site as a business office shall constitute a separate organization and shall require licensure.

D. Drop sites shall be subject to inspection at any time.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-381-280 Client record system

A. The organization shall maintain an organized client record system according to accepted standards of practice. Written policies and procedures shall specify retention, reproduction, access, storage, content, and completion of the record.

B. The client record information shall be safeguarded against loss or unauthorized use.

C. Client records shall be confidential. Only authorized personnel shall have access as specified by state and federal law.

D. Provisions shall be made for the safe storage of the original record and for accurate and legible reproductions of the original.

E. Policies shall specify arrangements for retention and protection of records if the organization discontinues operation and shall provide for notification to the OLC and the client of the location of the records.

F. An accurate and complete client record shall be maintained for each client receiving services and shall include, but shall not be limited to:

1. Client identifying information;

2. Identification of the primary care physician;

3. Admitting information, including a client history;

4. Information on the composition of the client's household, including individuals to be instructed in assisting the client;

5. An initial assessment of client needs to develop a plan of care or services;

6. A plan of care or service that includes the type and frequency of each service to be delivered either by organization personnel or contract services;

7. Documentation of client rights review; and

8. A discharge or termination of service summary.

In addition, client records for skilled and pharmaceutical services shall include:

9. Documentation and results of all medical tests ordered by the physician or other health care professional and performed by the organization's staff;

10. A medical plan of care including appropriate assessment and pain management;

11. Medication sheets that include the name, dosage, frequency of administration, possible side effects, route of administration, date started, and date changed or discontinued for each medication administered; and

12. Copies of all summary reports sent to the primary care physician.

G. Signed and dated notes on the care or services provided by each individual delivering service shall be written on the day the service is delivered and incorporated in the client record within seven working days.

H. Entries in the client record shall be current, legible, dated and authenticated by the person making the entry. Errors shall be corrected by striking through and initialing.

I. Originals or reproductions of individual client records shall be maintained in their entirety for a minimum of five years following discharge or date of last contact unless otherwise specified by state or federal requirements. Records of minors shall be kept for at least five years after the minor reaches 18 years of age.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008.

12VAC5-381-290 Home attendants

Home attendants shall be able to speak, read and write English and shall meet one of the following qualifications:

1. Have satisfactorily completed a nursing education program preparing for registered nurse licensure or practical nurse licensure;

2. Have satisfactorily completed a nurse aide education program approved by the Virginia Board of Nursing;

3. Have certification as a nurse aide issued by the Virginia Board of Nursing;

4. Be successfully enrolled in a nursing education program preparing for registered nurse or practical nurse licensure and have currently completed at least one nursing course that includes clinical experience involving direct client care;

5. Have satisfactorily passed a competency evaluation program that meets the criteria of 42 CFR 484.36 (b). Home attendants of personal care services need only be evaluated on the tasks in 42 CFR 484.36 (b) as those tasks relate to the personal care services to be provided; or

6. Have satisfactorily completed training using the "Personal Care Aide Training Curriculum," 2003 edition, of the Department of Medical Assistance Services. However, this training is permissible for home attendants of personal care services only.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

Part III Skilled Services

12VAC5-381-300 Skilled services

A. The organization shall provide a program of home health services that shall include one or more of the following:

1. Nursing services;

2. Physical therapy services;

3. Occupational therapy services;

4. Speech therapy services;

5. Respiratory therapy services; or

6. Medical social services.

B. All skilled services delivered shall be prescribed in a medical plan of care that contains at least the following information:

1. Diagnosis and prognosis;

2. Functional limitations;

3. Orders for all skilled services, including: (i) specific procedures, (ii) treatment modalities, and (iii) frequency and duration of the services ordered;

4. Orders for medications, when applicable; and

5. Orders for special dietary or nutritional needs, when applicable.

The medical plan of care shall be approved and signed by the client's primary care physician.

C. Verbal orders shall be documented within 24 consecutive hours in the client's record by the health care professional receiving the order and shall be countersigned by the prescribing person.

D. The primary care physician shall be notified immediately of any changes in the client's condition that indicates a need to alter the medical plan of care.

E. The medical plan of care shall be reviewed, approved, and signed by the primary care physician at least every 60 days.

F. There shall be a director of skilled services, who shall be a physician licensed by the Virginia Board of Medicine or a registered nurse, responsible for the overall direction and management of skilled services including the availability of services, the quality of services and appropriate staffing. The individual shall have the appropriate experience for the scope of services provided by the organization.

G. The organization shall develop and implement policies and procedures for the handling of drugs and biologicals, including procurement, storage, administration, self-administration, and disposal of drugs and shall allow clients to procure their medications from a pharmacy of their choice.

H. All prescription drugs shall be prescribed and properly dispensed to clients according to the provisions of Chapters 33 (§ 54.1-3300 et seq.) and 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia and the regulations of the Virginia Board of Pharmacy, except for prescription drugs authorized by § 54.1-3408 of the Drug Control Act, such as epinephrine for emergency administration, normal saline and heparin flushes for the maintenance of IV lines, and adult immunizations, which may be given by a nurse pursuant to established protocol.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-381-310 Nursing services

A. All nursing services shall be directly provided by an appropriately qualified registered nurse or licensed practical nurse, except for those nursing tasks that may be delegated by a registered nurse according to 18VAC90-20-420 through 18VAC90-20-460 of the regulations of the Virginia Board of Nursing and with a plan developed and implemented by the organization.

B. Supervision of services shall be provided as often as necessary as determined by the client's needs, the assessment by the registered nurse, and the organization's written policies not to exceed 90 days.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-381-320 Therapy services

A. Physical therapy, occupational therapy, speech therapy, or respiratory therapy services shall be provided according to the medical plan of care by or under the direction of an appropriately qualified therapist currently licensed in Virginia and may include, but are not limited to:

1. Assessing client needs or admission for service as appropriate;

2. Implementing a medical plan of care and revising as necessary;

3. Initiating appropriate preventive, therapeutic, and rehabilitative techniques according to the medical plan of care;

4. Educating the client and family regarding treatment modalities and use of equipment and devices;

5. Providing consultation to other health care professionals;

6. Communicating with the physician and other health care professionals regarding changes in the client's needs;

7. Supervising therapy assistants and home attendants as appropriate; and

8. Preparing clinical notes.

B. Therapy assistants may be used to provide therapy services.

1. The occupational therapy assistant shall be currently certified by the National Board for Certification in Occupational Therapy and shall practice under the supervision of a licensed occupational therapist.

2. The physical therapy assistant shall be currently licensed by the Virginia Board of Physical Therapy and shall practice under the supervision of a licensed physical therapist.

C. Duties of therapy assistants shall be within their scope of practice and may include, but are not limited to:

1. Performing services planned, delegated, and supervised by the appropriately licensed therapist; and

2. Preparing clinical notes.

D. Supervision of services shall be provided as often as necessary as determined by the client's needs, the assessment of the licensed therapist, and the organization's written policies not to exceed 90 days.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-381-330 Home attendants assisting with skilled services

A. Home attendants assisting with providing skilled services may:

1. Assist clients with (i) activities of daily living, (ii) ambulation and prescribed exercise, and (iii) other special duties with appropriate training and demonstrated competency;

2. Administer normally self-administered drugs as allowed by § 54.1-3408 of the Virginia Drug Control Act (Chapter 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia);

3. Measure and record fluid intake and output;

4. Take and record blood pressure, pulse and respiration;

5. Record and report to the appropriate health care professional changes in the client's condition;

6. Document services and observations in the client's record; and

7. Perform any other duties that the attendant is qualified to do by additional training and demonstrated competency as allowed by state or federal guidelines.

B. Prior to the initial delivery of services, the home attendant shall receive specific written instructions for the client's care from the appropriate health care professional responsible for the care.

C. Home attendants shall work under the supervision of the appropriate health care professional responsible for the client's care.

D. Relevant in-service education or training for home attendants shall consist of at least 12 hours annually. In-service training may be in conjunction with on-site supervision.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 27, Issue 26, eff. September 29, 2011.

12VAC5-381-340 Medical social services

A. Medical social services shall be provided according to the medical plan of care by or under the direction of a qualified social worker who holds, at a minimum, a bachelor's degree with major studies in social work, sociology, or psychology from a four-year college or university accredited by the Council on Social Work Education and has at least two years experience in case work or counseling in a health care or social services delivery system.

The organization shall have one year from January 1, 2006, to ensure the designated individual meets the qualifications of this standard.

B. The duties of a social worker may include, but are not limited to:

1. Assessing the client's psychological status;

2. Implementing a medical plan of care and revising, as necessary;

3. Providing social work services including (i) short-term individual counseling, (ii) community resource planning, and (iii) crisis intervention;

4. Providing consultation with the primary care physician and other health care professionals regarding changes in the client's needs;

5. Preparing notes on the care or services provided; and

6. Participating in discharge planning.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

Part IV Pharmaceutical Services

12VAC5-381-350 Pharmacy services

A. All prescription drugs shall be prescribed and properly dispensed to the client according to the provisions of the Chapters 33 (§ 54.1-3300 et seq.) and 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia and the regulations of the Virginia Board of Pharmacy, except for prescription drugs authorized by § 54.1-3408 of the Drug Control Act, such as epinephrine for emergency administration, normal saline and heparin flushes for the maintenance of IV lines, and adult immunizations, which may be given by a nurse pursuant to established protocol.

B. Home attendants may administer normally self-administered drugs as allowed by § 54.1-3408 of the Virginia Drug Control Act (Chapter 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia). Any other drug shall be administered only by a licensed nurse or physician assistant.

C. The organization shall develop written policies and procedures for the administration of home infusion therapy medications that include, but are not limited to:

1. Developing a plan of care or service;

2. Initiation of medication administration based on a prescriber's order and monitoring of the client for response to the treatment and any adverse reactions or side effects;

3. Assessment of any factors related to the home environment that may affect the prescriber's decisions for initiating, modifying, or discontinuing medications;

4. Communication with the prescriber concerning assessment of the client's response to therapy, any other client specific needs, and any significant change in the client's condition;

5. Communication with the client's provider pharmacy concerning problems or needed changes in a client's medication;

6. Maintaining a complete and accurate record of medications prescribed, medication administration data, client assessments, any laboratory tests ordered to monitor response to drug therapy and results, and communications with the prescriber and pharmacy provider;

7. Educating or instructing the client, family members, or other caregivers involved in the administration of infusion therapy in the proper storage of medication, in the proper handling of supplies and equipment, in any applicable safety precautions, in recognizing potential problems with the client, and actions to take in an emergency; and

8. Initial and retraining of all organization staff providing infusion therapy.

D. The organization shall employ a registered nurse, who has completed training in infusion therapy, and has the knowledge, skills, and competencies to safely administer infusion therapy, to supervise medication administration by staff. This person shall be responsible for ensuring compliance with applicable laws and regulations, adherence to the policies and procedures related to administration of medications, and conducting periodic assessments of staff competency in performing infusion therapy.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 27, Issue 26, eff. September 29, 2011.

Part V Personal Care Services

12VAC5-381-360 Personal care services

A. An organization may provide personal care services in support of the client's health and safety in his home. The organization shall designate a registered nurse responsible for the supervision of personal care services.

B. The personal care services shall include:

1. Assistance with the activities of daily living. A need for assistance exists when the client is unable to complete an activity due to cognitive impairment, functional disability, physical health problems, or safety. The client's functional level is based on the client's need for assistance most or all of the time to perform the tasks of daily living in order to live independently;

2. Administration of normally self-administered drugs as allowed in § 54.1-3408 of the Virginia Drug Control Act (Chapter 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia);

3. Taking and recording vital signs, if specified in the plan of service;

4. Recording and reporting to the supervisor any changes regarding the client's condition, behavior or appearance; and

5. Documenting the services delivered in the client's record.

Personal care services may also include the instrumental activities of daily living related to the needs of the client.

C. Such services shall be delivered based on a written plan of services developed by a registered nurse, in collaboration with the client and client's family. The plan shall include at least the following:

1. Assessment of the client's needs;

2. Functional limitations of the client;

3. Activities permitted;

4. Special dietary needs;

5. Specific personal care services to be performed; and

6. Frequency of service.

D. The plan shall be retained in the client's record. Copies of the plan shall be provided to the client receiving services and reviewed with the assigned home attendant prior to delivering services.

E. Supervision of services shall be provided as often as necessary as determined by the client's needs, the assessment of the registered nurse, and the organization's written policies not to exceed 90 days.

F. A registered nurse or licensed practical nurse shall be available during all hours that personal care services are being provided.

G. Home attendants providing personal care services shall receive at least 12 hours annually of inservice training and education. Inservice training may be in conjunction with on-site supervision.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 27, Issue 26, eff. September 29, 2011.

Chapter 391 Regulations for the Licensure of Hospice

Part I Definitions and General Information

12VAC5-391-10 Definitions

The following words and terms when used in these regulations shall have the following meaning unless the context clearly indicates otherwise.

"Activities of daily living" means bathing, dressing, toileting, transferring, bowel control, bladder control and eating/feeding.

"Administer" means the direct application of a controlled substance, whether by injection, inhalation, ingestion, or any other means, to the body of a patient by (i) a practitioner or by his authorized agent and under his supervision or (ii) the patient at the direction and in the presence of the practitioner as defined in § 54.1-3401 of the Code of Virginia.

"Administrator" means a person designated, in writing, by the governing body as having the necessary authority for the day-to-day management of the hospice program. The administrator must be a member of the hospice staff. The administrator, director of nursing, or another clinical director may be the same individual if that individual is dually qualified.

"Adverse outcome" means the result of drug or health care therapy that is neither intended nor expected in normal therapeutic use and that causes significant, sometimes life-threatening conditions or consequences at some future time. Such potential future adverse outcome may require the arrangement of appropriate follow-up surveillance and perhaps other departures from the usual plan of care.

"Attending physician" means a physician licensed in Virginia, according to Chapter 29 (§ 54.1-2900 et seq.) of Title 54.1 of the Code of Virginia, or licensed in an adjacent state and identified by the patient as having the primary responsibility in determining the delivery of the patient's medical care. The responsibilities of physicians contained in this chapter may be implemented by nurse practitioners or physician assistants as assigned by the supervising physician and within the parameters of professional licensing.

"Available at all times during operating hours" means an individual is available on the premises or by telecommunications.

"Barrier crimes" means certain offenses specified in § 32.1-162.9:1 of the Code of Virginia that automatically bar an individual convicted of those offenses from employment with a hospice program.

"Bereavement service" means bereavement counseling as defined in 42 CFR 418.3.

"Cannabidiol oil" means the same as that term is defined in subsection A of § 54.1-3408.3 of the Code of Virginia.

"Commissioner" means the State Health Commissioner.

"Coordinated program" means a continuum of palliative and supportive care provided to a terminally ill patient and the patient's family, 24 hours a day, seven days a week.

"Core services" means those services that must be provided by a hospice program. Such services are: (i) nursing services, (ii) physician services, (iii) counseling services, and (iv) medical social services.

"Counseling services" means the provision of bereavement services, dietary services, spiritual and any other counseling services for the patient and family while the person is enrolled in the program.

"Criminal record report" means the statement issued by the Central Criminal Records Exchange, Virginia Department of State Police.

"Designated support person" means a person who is knowledgeable about the needs of a person with a disability and who is designated, orally or in writing, by the individual with a disability, the individual's guardian, or the individual's care provider to provide support and assistance, including physical assistance, emotional support, assistance with communication or decision-making, or any other assistance necessary as a result of the person's disability, to the person with a disability at any time during which health care services are provided.

"Dispense" means to deliver a drug to the ultimate user by or pursuant to the lawful order of a practitioner, including the prescribing and administering, packaging, labeling or compounding necessary to prepare the substance for that delivery as defined in § 54.1-3401 of the Code of Virginia.

"Employee" means an individual who is appropriately trained and performs a specific job function for the hospice program on a full-time or part-time basis with or without financial compensation.

"Governing body" means the individual, group, or governmental agency that has legal responsibility and authority over the operation of the hospice program.

"Home attendant" means a nonlicensed individual performing personal care and environmental services, under the supervision of the appropriate health professional, to a patient in the patient's residence. Home attendants are also known as certified nursing assistants or CNAs, home care aides, home health aides, and personal care aides.

"Hospice" means a hospice as defined in § 32.1-162.1 of the Code of Virginia.

"Hospice facility" means an institution, place, or building as defined in § 32.1-162.1 of the Code of Virginia.

"Inpatient" means the provision of services, such as food, laundry, housekeeping, and staff to provide health or health-related services, including respite and symptom management, to hospice patients, whether in a hospital, nursing facility, or hospice facility.

"Interdisciplinary group" means the group responsible for assessing the health care and special needs of the patient and the patient's family. Providers of special services, such as mental health, pharmacy, and any other appropriate associated health services may also be included on the team as the needs of the patient dictate. The interdisciplinary group is often referred to as the IDG.

"Licensee" means a licensed hospice program provider.

"Medical director" means a physician currently licensed in Virginia, according to Chapter 29 (§ 54.1-2900 et seq.) of Title 54.1 of the Code of Virginia, and responsible for the medical direction of the hospice program.

"Medical record" means a continuous and accurate documented account of services provided to a patient, including the prescription and delivery of the treatment or care.

"Medication error" means one or more violations of the five principles of medication administration: the correct drug to the right patient at the prescribed time in the prescribed dose via the prescribed route.

"Nursing services" means the patient care performed or supervised by a registered nurse according to a plan of care.

"OLC" means the Office of Licensure and Certification of the Virginia Department of Health.

"Operator" means any individual, partnership, association, trust, corporation, municipality, county, local government agency, or any other legal or commercial entity responsible for the day-to-day administrative management and operation of the hospice.

"Palliative care" means treatment directed at controlling pain, relieving other symptoms, and focusing on the special needs of the patient and family as they experience the stress of the dying process. Palliative care means treatment to enhance comfort and improve the quality of a patient's life during the last phase of his life.

"Patient" means a hospice patient as defined in § 32.1-162.1 of the Code of Virginia.

"Patient's family" means a hospice patient's family as defined in § 32.1-162.1 of the Code of Virginia.

"Patient's residence" means the place where the individual or patient makes his home.

"Person" means any individual, partnership, association, trust, corporation, municipality, county, local government agency, or any other legal or commercial entity that operates a hospice.

"Plan of care" means a written plan of services developed by the interdisciplinary group to maximize patient comfort by symptom control to meet the physical, psychosocial, spiritual, and other special needs that are experienced during the final stages of illness, during dying, and bereavement.

"Primary caregiver" means an individual that, through mutual agreement with the patient and the hospice program, assumes responsibility for the patient's care.

"Progress note" means a documented statement contained in a patient's medical record, dated and signed by the person delivering the care, treatment, or service, describing the treatment or services delivered and the effect of the care, treatment, or services on the patient.

"Quality improvement" means ongoing activities designed to objectively and systematically evaluate the quality of care and services, pursue opportunities to improve care and services, and resolve identified problems. Quality improvement is an approach to the ongoing study and improvement of the processes of providing services to meet the needs of patients and their families.

"Separate and distinct entrance" means an entrance to the hospice facility other than the formal public entrance used by patients and family members.

"Staff" means an employee who receives financial compensation.

"Supervision" means the ongoing process of monitoring the skills, competencies, and performance of the individual supervised and providing regular face-to-face guidance and instruction.

"Terminally ill" means a medical prognosis that life expectancy is six months or less if the illness runs its usual course.

"THC-A oil" means the same as that term is defined in subsection A of § 54.1-3408.3 of the Code of Virginia.

"Volunteer" means an employee who receives no financial compensation.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008; Volume 26, Issue 26, eff. September 30, 2010; Volume 27, Issue 11, eff. March 2, 2011; Volume 36, Issue 23, eff. August 6, 2020; Volume 37, Issue 15, eff. April 14, 2021.

12VAC5-391-20 [Reserved]

Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005.

12VAC5-391-30 License

A. A license to operate a hospice program is issued to a person.

B. The State Health Commissioner shall issue or renew a license to establish or operate a hospice program if the commissioner finds that the hospice program is in compliance with the law and this chapter.

C. A separate license shall be required for hospice programs maintained at separate locations, even though they are owned or are operated under the same management.

D. Every hospice program shall be designated by an appropriate name. The name shall not be changed without first notifying the OLC.

E. Licenses shall not be transferred or assigned.

F. Any person establishing, conducting, maintaining, or operating a hospice program without a license shall be guilty of a Class 1 misdemeanor according to § 32.1-27 of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008.

12VAC5-391-40 Exemption from licensure

A. This chapter is not applicable to hospice programs described in § 32.1-162.2 of the Code of Virginia.

B. The hospice program must file a request for exemption from licensure in writing to the director of the OLC. The request shall contain documentation explaining the hospice program's relationship to the practice of religious tenets of a recognized church or denomination.

C. The hospice program shall be notified in writing that the exemption from licensure has been registered.

D. Exempt hospice programs shall remain subject to complaint investigations in keeping with state law.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008; Volume 26, Issue 26, eff. September 30, 2010.

12VAC5-391-50 License application; initial and renewal

A. The OLC will provide prelicensure consultation and technical assistance to any person regarding the licensure process. The purpose of such consultation is to explain the regulation and to review an applicant's proposed hospice program plans, forms, and other documents, as they relate to the regulation. Prelicensure consultations can be arranged after an initial application has been filed.

B. Licensure applications are obtained from the OLC. The OLC shall consider an application complete when all requested information and the appropriate fee, stated in 12VAC5-391-70, are submitted. If the OLC finds the application incomplete, the applicant will be notified in writing of the incomplete application.

An incomplete application shall become inactive six months after it is received by the OLC. Applicants must reapply for licensure with a completed application and application fee. An application for a license may be withdrawn at any time.

C. A completed application for initial licensure must be submitted at least 60 days prior to the hospice program's planned opening date to allow the OLC time to act on the application.

D. The activities and services of each applicant or licensee of a hospice license shall be subject to an inspection by the OLC to determine if the hospice program is in compliance with the provisions of this chapter and state law. Hospice programs submitting an initial application shall receive an announced inspection prior to accepting patients.

E. Licenses are renewed annually. The OLC shall make renewal applications available at least 60 days prior to the expiration date of the current license.

F. The hospice program shall submit the completed renewal application form along with any required attachments and the application fee by the date indicated in the cover letter. Providers operating dedicated hospice facilities shall include a copy of the facility deficiency report and plan of correction from their latest facility licensure inspection when applying to renew their hospice program license.

G. It is the hospice program's responsibility to complete and return the renewal application to assure timely processing. Should a current license expire before a new license is issued, the current license shall remain in effect provided a complete and accurate application was filed on time.

H. Providers operating a dedicated hospice facility shall maintain compliance with the applicable licensure regulations described in 12VAC5-391-120. Failure to maintain compliance may be taken into consideration in the OLC decision to renew a hospice program license.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008.

12VAC5-391-60 Changes to or reissuance of a license

A. It is the responsibility of the hospice program's governing body to maintain a current and accurate license, including appropriate facility licensure if the hospice program operates a dedicated hospice facility.

B. A hospice program shall give written notification 30 working days in advance of any proposed changes that may require the reissuance of the license. Notices shall be sent to the attention of the director of the OLC.

The following circumstances require the reissuance of a license and payment of a fee:

1. A change in ownership or operator;

2. A change in hospice program name; or

3. Relocation of the hospice program's administrative office.

C. The OLC will evaluate written information about any planned changes in operation that affect the terms of the license or the continuing eligibility for a license. A licensing representative may inspect the hospice program during the process of evaluating a proposed change.

D. The hospice program will be notified in writing whether a license can be reissued or a new application is needed.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008.

12VAC5-391-70 Fees

A. The OLC shall collect a fee of $500 for each initial and renewal license. Fees shall accompany the licensure application and are not refundable.

B. A processing fee of $250 shall be collected for each reissuance or replacement of a license and shall accompany the written request for reissuance or replacement.

C. In addition, a late fee of $50 shall be collected for a hospice program's failure to file a renewal application by the date specified.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008.

12VAC5-391-80 On-site inspections

A. A OLC representative shall make periodic unannounced on-site inspections of the hospice program as necessary, but not less often than biennially. The hospice program shall be responsible for correcting any deficiencies found during any on-site inspection, including deficiencies found during announced initial inspections. Compliance with all standards will be determined by the OLC according to applicable law. The administrator will be notified whenever any item in the plan of correction is determined to be unacceptable.

B. The hospice program shall make available to the OLC representative any necessary records and shall allow access to interview the agents, employees, contractors, and any person under its control, direction or supervision.

C. After the on-site inspection, the OLC representative shall discuss the findings of the inspection with the administrator or designee.

D. The administrator shall submit, within 15 working days from the date of the deficiency report, an acceptable plan for correcting any deficiencies found during an on-site inspection. The plan of correction shall contain:

1. A description of the corrective action or actions to be taken and the personnel to implement and monitor the corrective action;

2. The expected correction date;

3. A description of the measures implemented to prevent a recurrence of the violation; and

4. The signature of the hospice program's administrator.

E. The administrator shall be responsible for assuring the plan of correction is implemented and monitored so that compliance is maintained.

F. Completion of corrective actions shall not exceed 45 working days from the last day of the inspection.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008.

12VAC5-391-90 Home visits

A. As part of any inspection, an OLC representative may conduct home visits subject to obtaining consent from the patient and the patient's family or caretaker.

B. The hospice program shall be responsible for arranging in-home visits with patients, family members, and caregivers for the OLC representative.

C. The hospice program shall explain clearly to the patient, patient's family or caretaker, that a home visit is voluntary and that refusal to consent to a home visit will in no way affect the patient's care.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008.

12VAC5-391-100 Complaint investigation

A. The OLC has the responsibility to investigate any complaints regarding alleged violations of this chapter and applicable law.

B. Complaints may be received in written or oral form and may be anonymous.

C. When the investigation is complete, the licensee and the complainant, if known, will be notified in writing of the findings of the investigation.

D. The administrator shall submit an acceptable plan for correcting any deficiencies found during a complaint investigation.

E. The administrator will be notified in writing whenever any aspect of the plan of correction is determined to be unacceptable.

F. The administrator shall be responsible for assuring the plan of correction is implemented and monitored so that compliance is maintained.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008.

12VAC5-391-110 Criminal records checks

A. Section 32.1-162.9:1 of the Code of Virginia requires hospice providers, as defined in § 32.1-162.1 of the Code of Virginia, to obtain a criminal record report on applicants for compensated employment from the Virginia Department of State Police. Section 32.1-162.9:1 also requires that all applicants for compensated employment in a hospice program provide a sworn statement regarding their criminal history.

B. The criminal record report shall be obtained within 30 days of compensated employment. It is the hospice program's responsibility to ensure that its compensated employees have not been convicted of any of the barrier crimes listed in § 32.1-162.9:1 of the Code of Virginia.

C. The hospice program shall not accept a criminal record report dated more than 90 days prior to the date of compensated employment.

D. Only the original criminal record report shall be accepted. An exception is permitted for hospice programs using temporary staffing agencies for the provision of substitute staff. The hospice program shall obtain a letter from the temporary staffing agency containing the following information:

1. The name of the substitute staffing person;

2. The date of employment by the temporary staffing agency; and

3. A statement verifying that the criminal record report has been obtained within 30 days of employment, is on file at the temporary staffing agency, and does not contain any barrier crimes listed in § 32.1-162.9:1 of the Code of Virginia.

E. A criminal record report remains valid as long as the compensated employee remains in continuous service with the same hospice program.

F. A new criminal record report shall be required when an individual terminates compensated employment at one hospice program and begins compensated employment at another hospice program. The following exceptions are permitted:

1. When an employee transfers, within 30 days, to a hospice program owned and operated by the same entity. The employee's file shall contain a statement indicating that the original criminal record report has been transferred or forwarded to the new work location.

2. A criminal record report for an individual who takes a leave of absence will remain valid as long as the period of separation does not exceed six consecutive months. If a period of six consecutive months has passed, a new criminal record report and sworn disclosure statement are required.

G. The sworn disclosure statement shall be completed by all applicants for compensated employment. The sworn disclosure statement shall be attached to and filed with the criminal record report.

H. Any applicant denied compensated employment because of convictions appearing on his criminal record report shall be provided a copy of the report by the hiring hospice program.

I. All criminal records reports shall be confidential and maintained in locked files accessible only to the administrator or designee.

J. Further dissemination of the criminal record report and sworn disclosure statement information is prohibited other than to the commissioner's representative or a federal or state authority or court as may be required to comply with an express requirement of law for such further dissemination.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005.

12VAC5-391-120 Hospice facilities

A. Providers seeking to operate a hospice facility shall comply with the appropriate facility licensing regulation as follows:

1. Facilities with 16 or fewer beds shall be licensed as a hospice facility pursuant to this chapter. Such facilities with six or more beds shall obtain a Certificate of Use and Occupancy with a Use Group designation of I-2; or

2. Facilities with more than 16 beds shall be licensed as a hospital pursuant to 12VAC5-410 or as a nursing facility pursuant to 12VAC5-371. Such facilities shall obtain the applicable Certificate of Public Need prior to the development or construction of the facility.

B. Only patients diagnosed terminally ill shall be admitted to a hospice facility. The facility shall admit only those patients whose needs can be met by the accommodations and services provided by the facility.

C. To the maximum extent possible, care shall be provided in the patient's home. Admission to a hospice facility shall be the decision of the patient in consultation with the patient's physician. No patient shall be admitted to a hospice facility at the discretion of, or for the convenience of, the hospice provider, the primary caregiver, or the family.

D. All hospice providers operating a hospice facility shall use its facility to provide, to the extent possible, respite and symptom management services to all patients in the hospice program needing such services.

E. If the Governor has declared a public health emergency related to the novel coronavirus (COVID-19), all hospice providers operating a hospice facility shall allow a person with a disability who requires assistance as a result of such disability to be accompanied by a designated support person at any time during which health care services are provided.

1. If the duration of health care services in a hospice facility is anticipated to last more than 24 hours, the person with a disability may designate more than one designated support person. However, no hospice facility shall be required to allow more than one designated support person to be present with a person with a disability at any time.

2. A designated support person shall not be subject to any restrictions on visitation adopted by the hospice facility. However, such designated support person may be required to comply with all reasonable requirements of the hospice facility adopted to protect the health and safety of patients and staff of the hospice facility.

3. Every hospice provider operating a hospice facility shall establish policies applicable to designated support persons and shall:

a. Make such policies available to the public on a website maintained by the hospice facility; and

b. Provide such policies in writing to the patient at such time as health care services are provided.

F. No hospice facility shall receive patients for care, palliative treatment, respite, or symptom management services in excess of its licensed bed capacity.

G. No hospice facility provider shall add additional patient beds or renovate facility space without first notifying the OLC. OLC notifications must be in writing to the director of the OLC.

H. The OLC will not accept any requests for variances to this section.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008; Volume 27, Issue 11, eff. March 2, 2011; Volume 37, Issue 15, eff. April 14, 2021.

12VAC5-391-130 Variances

A. The OLC can authorize variances only to its own licensing regulations, not to regulations of another agency or to any requirements in federal, state, or local laws.

B. A hospice program may request a variance to a particular regulation or requirement contained in this chapter when the standard or requirement poses a special hardship and when a variance to it would not endanger the safety or well-being of patients. The request for a variance must describe the special hardship to the hospice program and to the patients it serves. When applicable, the request should include proposed alternatives to meet the purpose of the requirements that will ensure the protection and well-being of patients. At no time shall a variance approved for one individual be extended to general applicability. If a variance is denied, expires, or is rescinded, routine enforcement of the regulation or portion of the regulation shall be resumed. The hospice program may at any time withdraw a request for a variance.

C. The OLC shall have the authority to waive, either temporarily or permanently, the enforcement of one or more of these regulations provided safety, patient care and services are not adversely affected. The OLC may attach conditions to the granting of the variance in order to protect persons in care.

D. The OLC may rescind or modify a variance when (i) conditions change; (ii) additional information becomes known that alters the basis for the original decision; (iii) the hospice program fails to meet any conditions attached to the variance; or (iv) results of the variance jeopardize the safety, comfort, or well-being of persons in care.

E. Consideration of a variance is initiated when a written request is submitted to the director of the OLC. The OLC shall notify the hospice program in writing of the receipt of the request for a variance.

F. The licensee shall be notified in writing if the requested variance is denied.

G. The hospice program shall develop procedures for monitoring the implementation of any approved variance to assure the ongoing collection of any data relevant to the variance and the presentation of any later report concerning the variance as requested by the OLC.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008.

12VAC5-391-140 Revocation or suspension of a license

A. The commissioner is authorized to revoke or suspend any license if the licensee fails to comply with the provisions of Article 7 (§ 32.1-162.1 et seq.) of Chapter 5 of Title 32.1 of the Code of Virginia or the regulations of the board.

Providers operating a dedicated hospice facility shall also maintain compliance with the applicable licensure regulations as described in 12VAC5-391-120. Failure to maintain compliance may be taken into consideration when the commissioner decides to revoke or suspend a hospice program license.

B. If a license is revoked, the commissioner may issue a new license when the conditions upon which revocation was based have been corrected and compliance with all provisions of the law and this chapter has been achieved.

C. Suspension of a license shall in all cases be for an indefinite time. The suspension may be lifted and rights under the license fully or partially restored at such time as the commissioner determines that the interests of the public will not be jeopardized by resumption of services.

D. When a license is revoked or suspended, the hospice program shall cease operations. If the hospice program continues operating, the commissioner may request the Office of the Attorney General to petition the circuit court of the jurisdiction in which the hospice program is located for an injunction to cause such hospice program to cease operations.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005.

12VAC5-391-150 Return of a license

A. The circumstances under which a license must be returned include:

1. A change in ownership or operator;

2. A change in program name;

3. The relocation of the administrative office;

4. The discontinuation of any core services; and

5. The relocation of a hospice facility.

B. The licensee shall notify its patients and the OLC in writing 30 days prior to discontinuing any services.

C. If the hospice program is no longer operational, or the license is revoked or suspended, the license shall be returned to the OLC within five working days. The licensee is responsible for notifying its patients and the OLC where all medical records will be located.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008; Volume 27, Issue 11, eff. March 2, 2011.

Part II Administrative Services

12VAC5-391-160 Management and administration

A. No person shall establish or operate a hospice program or a hospice facility, as defined in § 32.1-162.1 of the Code of Virginia, without having obtained a license.

B. The hospice program must comply with:

1. This chapter (12VAC5-391);

2. Other applicable federal, state or local laws and regulations; and

3. The hospice program's own policies and procedures.

When applicable regulations are similar, the more stringent regulation shall take precedence.

C. The hospice program shall submit or make available reports and information necessary to establish compliance with this chapter and applicable law.

D. The hospice program shall permit representatives from the OLC to conduct inspections to:

1. Verify application information;

2. Determine compliance with this chapter;

3. Review necessary records and documents; and

4. Investigate complaints.

E. The hospice program shall notify the OLC 30 working days in advance of changes effecting the hospice program, including the:

1. Location of the administrative office or mailing address of the hospice program;

2. Ownership or operator;

3. Services provided;

4. Administrator;

5. Hospice program name;

6. Establishment or relocation of a hospice facility; and

7. Closure of the hospice program.

F. The current license from the department shall be posted for public inspection.

G. Service providers or individuals under contract must comply with the hospice program's policies and this chapter, as appropriate.

H. The hospice program shall not use any advertising that contains untrue, deceptive, or misleading statements or claims or untrue, deceptive, or misleading disclosures of fees and payment for services.

I. The hospice program shall have regular posted business hours and be fully operational during business hours. Patient care services shall be available 24 hours a day, seven days a week. This does not mean that a hospice program must accept new clients on an emergency basis during nonbusiness hours.

J. The hospice program shall accept a patient only when the hospice program can adequately meet that patient's needs.

K. The hospice program must have an emergency preparedness plan in case of inclement weather, natural disaster, or pandemic disease outbreaks to include contacting and providing essential care to patients, coordinating with community agencies to assist as needed, and maintaining current information on patients who would require specialized assistance.

L. The hospice program shall encourage and facilitate the availability of flu shots for its staff and patients.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008; Volume 27, Issue 11, eff. March 2, 2011.

12VAC5-391-170 Governing body

A. The hospice program shall have a governing body that is legally responsible for the management, operation and fiscal affairs of the hospice program. The governing body of the hospital, nursing facility or home health agency that operates a hospice shall include in its internal organizational structure an identifiable unit of hospice services.

B. The governing body shall adopt written by-laws describing the hospice program structure, including the:

1. Hospice program's objectives;

2. Scope of services;

3. Relationship of the hospice program's services to other services operated by the governing body, if applicable, or by written agreement with the governing body of an affiliated medical service provider; and

4. Establishment of a quality improvement committee.

At least every two years, the governing body shall review and approve necessary changes to the program's by-laws.

C. The governing body shall review annually and approve the recommendations of the quality improvement committee.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005.

12VAC5-391-180 Administrator

A. The governing body shall appoint as administrator an individual who has evidence of at least one year of training and experience in direct health care service delivery with at least one year, within the last five years, of supervisory or administration management experience in hospice care or a related health care delivery system.

B. The administrator shall have operational knowledge of Virginia's hospice laws and regulations and the interrelationship between state licensure and other applicable state laws and regulations as well as national certification or accrediting organizations such as the Centers for Medicare and Medicaid Services and The Joint Commission (formerly the Joint Commission on Accreditation of Healthcare Organizations).

C. The administrator shall be responsible for the day-to-day management of the hospice program, including but not limited to:

1. Organizing and supervising the administrative functions of the hospice program;

2. Maintaining an ongoing liaison with the governing body, the professional personnel and staff;

3. Employing qualified personnel and ensuring adequate employee orientation, training, education and evaluation;

4. Ensuring the accuracy of public information materials and activities;

5. Implementing an effective budgeting and accounting system;

6. Maintaining compliance with applicable laws and regulations and implementing corrective action in response to reports of hospice program committees and regulatory agencies;

7. Arranging and negotiating services provided through contractual agreement; and

8. Implementing the policies and procedures approved by the governing body.

D. The individual designated to perform the duties of the administrator when the administrator is absent from the hospice program shall be able to perform those duties of the administrator as identified in subsection C of this section.

E. The administrator or alternate shall be available at all times during operating hours and for emergency situations.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 27, Issue 11, eff. March 2, 2011.

12VAC5-391-190 Written policies and procedures

A. The hospice program shall implement written policies and procedures approved by the governing body.

B. All policies and procedures shall be reviewed at least annually, with recommended changes submitted to the governing body for approval, as necessary.

C. Administrative and operational policies and procedures shall include:

1. Administrative records;

2. Admission and discharge criteria;

3. Informed consent;

4. Advance directives, including Durable Do Not Resuscitate Orders;

5. Patient rights;

6. Pain assessment and management;

7. Medical supplies and appliances including drugs and biologicals, disposal of controlled drugs when no longer needed by patients, and handling of medications procured from a pharmacy of the patient's choice;

8. Contract services;

9. Transfer of patients to an inpatient facility including arrangements for an ambulance and the patient escort, when appropriate, to the facility by a professional staff member of the hospice program;

10. Medical social services;

11. Quality improvement;

12. Communicable and reportable diseases;

13. Post-mortem activities;

14. Mandated reporting of abuse, neglect, and exploitation pursuant to § 63.2-1606 of the Code of Virginia;

15. Medical records, including confidentiality;

16. Record retention, including termination of services;

17. Supervision and delivery of services;

18. Interdisciplinary group duties and responsibilities;

19. Bereavement and spiritual services;

20. Volunteer services;

21. Infection control;

22. Special services;

23. Emergency preparedness;

24. Handling consumer complaints; and

25. Approved variances.

D. Financial policies and procedures shall include:

1. Admission agreements;

2. Data collection and verification of services delivered;

3. Methods of billing for services by the hospice program and contractors;

4. Patient notification of changes in fees and charges;

5. Refund policy and correction of billing errors; and

6. Collection of delinquent patient accounts.

E. Personnel policies and procedures shall include a:

1. Written job description specifying responsibility, qualifications, and authority for each job classification;

2. Process for obtaining a criminal background check;

3. Process for maintaining an accurate, complete, and current personnel record for each employee;

4. Process for verifying current professional credentials and training of employees, or independent contractors;

5. Process for annually evaluating employee performance and competency;

6. Process for verifying that contractors and their employees meet the personnel qualifications of the hospice program; and

7. Process for reporting licensed and certified medical personnel for violations of the licensing or certification to the appropriate board within the Department of Health Professions.

F. Admission and discharge policies and procedures shall include:

1. Criteria for accepting patients;

2. The process for assessing a patient and maintaining a plan of care;

3. Criteria for determining discharge from hospice and referral to other agencies or community services; and

4. Process for notifying patients of intent to discharge or refer, including:

a. Oral and written notice and explanation of the reason for discharge or referral;

b. The name, address, telephone number, and contact name at the referral hospice program; and

c. Documentation in the medical record of the referral or notice.

G. Policies shall be made available for review, upon request, to patients and their designated representatives.

H. Policies and procedures shall be readily available for staff use at all times.

I. The hospice program shall establish policies and procedures for the disposal of drugs dispensed as part of the hospice plan of care to include:

1. Disposal shall be performed by a licensed nurse, physician assistant, or physician employed by or under contract with the hospice program;

2. Disposal shall be witnessed by a patient's family member or another employee of the hospice program who is licensed by a health regulatory board within the Department of Health Professions;

3. Disposal shall be documented in the patient's medical record; and

4. Disposal shall comply with all state and federal requirements for the safe disposal of drugs.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 35, Issue 4, eff. November 14, 2018.

12VAC5-391-200 Financial controls

A. The hospice program shall document financial resources to operate based on a working budget showing projected revenue and expenses. Hospice programs operating dedicated hospice facilities shall have financial resources to operate based on a separate working budget showing projected revenue and expenses.

B. All financial records shall be kept according to generally accepted accounting principles (GAAP).

C. All financial records shall be audited at least triennially by an independent certified public accountant or audited as otherwise provided by law.

D. The hospice program shall have documented financial controls to minimize risk of theft or embezzlement.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005.

12VAC5-391-210 Personnel practices

A. Personnel management and employment practices shall comply with applicable state and federal laws and regulations.

B. The hospice program shall design and implement a staffing plan that reflects the types of services offered and shall provide qualified staff in sufficient numbers to meet the assessed needs of all patients, including those patients residing in the provider's hospice facility, if applicable.

C. Employees and contractors shall be licensed or certified as required by the Department of Health Professions.

D. The hospice program shall implement a mechanism to verify professional credentials.

E. Any person who assumes the responsibilities of any staff position or positions shall meet the minimum qualifications for that position or positions. Professional staff may be assigned multiple job responsibilities provided the individual is appropriately qualified.

F. The hospice program shall obtain the required sworn statement and criminal record check for each compensated employee as specified in § 32.1-162.9:1 of the Code of Virginia.

G. Each employee position shall have a written job description that includes:

1. Job title;

2. Duties and responsibilities required of the position;

3. Job title of the immediate supervisor; and

4. Minimum knowledge, skills, and abilities or professional qualifications required for entry level.

H. Employees shall have access to their current position description. There shall be a mechanism for advising employees of changes to their job responsibilities.

I. New employees and contract individuals shall be oriented commensurate with their function or job-specific responsibilities. Orientation shall include:

1. Objectives and philosophy of the hospice program;

2. Confidentiality practices;

3. Patient rights;

4. Mandated reporting of abuse, neglect and exploitation;

5. Applicable personnel policies;

6. Emergency preparedness procedures;

7. Infection control practices and measures; and

8. Applicable laws, regulations, and other policies and procedures that apply to specific positions and specific duties and responsibilities.

J. The hospice program shall implement a policy for evaluating employee performance.

K. Individual staff development needs and plans shall be a part of the performance evaluation.

L. The hospice program shall provide opportunities for and record participation in staff development activities designed to enable staff to perform the responsibilities of their positions.

M. All individuals who enter a patient's home for or on behalf of the hospice program shall be readily identifiable by employee nametag.

N. The hospice program shall maintain an organized system to manage and protect the confidentiality of personnel files and records.

O. Employee personnel records, whether hard-copy or electronic, shall include:

1. Identifying information;

2. Education and training history;

3. Employment history;

4. Results of the verification of applicable professional licenses or certificates;

5. Results of reasonable efforts to secure job-related references and reasonable verification of employment history;

6. Results of performance evaluations;

7. A record of disciplinary actions taken by the hospice program, if any;

8. A record of adverse action by any licensing bodies and hospice programs, if any;

9. A record of participation in staff development activities, including orientation;

10. The criminal record check; and

11. A signed job description.

P. Each employee personnel record shall be retained in its entirety for a minimum of three years after termination of employment.

Q. Personnel record information shall be safeguarded against loss and unauthorized use.

R. Employee health-related information shall be maintained separately within the hospice program's personnel files, but may be maintained in a separate secure section for confidentiality.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005.

12VAC5-391-220 Indemnity coverage

A. The governing body shall ensure the hospice program and its contractors have appropriate indemnity coverage to compensate patients for injuries and losses resulting from services provided.

B. To protect the interests of patients, employees, and the hospice program from risks of liability, there shall be indemnity coverage to include:

1. General liability insurance covering personal property damages, bodily injuries, product liability, liable and slander of at least $1 million comprehensive general liability per occurrence; and

2. Malpractice insurance for all nursing and medical professional employees consistent with § 8.01-581.15 of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005.

12VAC5-391-230 Contract services

A. If the hospice program contracts for services, there shall be a written agreement for the provision of those services.

B. The written agreement shall include, but is not limited to:

1. The services to be furnished by each party to the contract;

2. The contractor's responsibility for participating in developing plans of care;

3. The manner in which services will be controlled, coordinated, and evaluated by the hospice program;

4. The procedures for submitting clinical and progress notes, scheduling of visits, and periodic patient evaluation;

5. The process for payment for services furnished under the contract; and

6. Adequate indemnity coverage.

C. The hospice program shall have procedures for providing patient services in the event the contractor is unable to comply with the plan of care.

D. The contractor shall conform to applicable hospice program policies and procedures as specified in the contract, including the required sworn statement and criminal record check.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005.

12VAC5-391-240 Patient rights

A. The hospice program shall establish and implement written policies and procedures regarding the rights of patients. A copy of the patient's rights shall be displayed in the hospice office for public review.

B. Written procedures to implement the policies shall ensure that each patient is:

1. Treated with courtesy, consideration and respect;

2. Assured the right to privacy;

3. Assured confidential treatment of his medical and financial records as provided by law;

4. Free from mental and physical abuse and property exploitation;

5. Assured the right to participate in the planning of his care, including appropriate assessment and management of pain and the right to refuse services;

6. Served by individuals who are properly trained and competent to perform their duties;

7. Assured the right to voice grievances and complaints related to hospice program services without fear of reprisal;

8. Advised, before care is initiated, of the extent to which payment for services may be expected from federal or state programs, and the extent to which payment may be required from the patient;

9. Advised orally and in writing of any changes in fees for services that are the patient's responsibility. The hospice program shall advise the patient of these changes as soon as possible but no later than 30 calendar days from the date the hospice program became aware of the change;

10. Provided with advance directive and Durable Do Not Resuscitate Order information prior to start of services; and

11. Given five days oral and written notice when the hospice program determines to terminate services.

C. At the time of admission, patient rights shall be reviewed with patients and primary caregivers who shall receive a written summary of the policies. The review shall be documented in the patient's record.

D. Before care is initiated, the hospice program shall inform the patient, orally and in writing, of the general nature of hospice care and policies of the hospice program, including, but not limited to:

1. The type and frequency of service or services to be delivered, the purpose of the service or services, and the name of the individual supervising the service or services;

2. Any anticipated effects of treatment, as applicable:

3. A schedule of charges for services;

4. The method of billing and payment for services, including the:

a. Services to be billed to third party payers;

b. Extent to which payment may be expected from third party payers known to the hospice program; and

c. Services that may not be covered by third party payers;

5. The charges that the individual may have to pay;

6. The requirements of notice for cancellation or reduction in services by the hospice program and the patient; and

7. The refund policies of the hospice program.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005.

12VAC5-391-250 Complaints

A. The hospice program shall establish and maintain complaint handling procedures that specify the:

1. System for logging receipt, investigation and resolution of complaints;

2. Format of the written record;

3. Method in which the adult protective services unit of the local social services department is to be informed and for what complaints; and

4. Description of the appeal rights if a complainant is not satisfied with the resolution.

B. The hospice program shall designate staff responsible for complaint resolution, including:

1. Complaint intake, including acknowledgment of complaints;

2. Investigation of the complaint;

3. Review of the investigation of findings and resolution of the complaint; and

4. Written notification to the complainant of the proposed resolution within 30 days from the date of receipt of the complaint.

C. The patient or his designee shall be given a copy of the hospice program's procedures for filing a complaint at the time of admission to service. The hospice program shall provide each patient or his designee with the name, mailing address, and telephone number of the:

1. Hospice program contact person;

2. State Ombudsman; and

3. Complaint Unit of the OLC.

D. The hospice program shall maintain documentation of all complaints received and the status of each complaint from date of receipt through its final resolution. Records shall be maintained from the date of the last licensure inspection and for no less than three years.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008.

12VAC5-391-260 Quality improvement

A. The hospice program shall implement an on-going, comprehensive, integrated, self-assessment program of the quality and appropriateness of care provided, including services provided under contract. The quality improvement program shall address actual patient outcomes (results of care), clinical, administrative, and cost-of-care issues. The findings shall be used to correct identified problems and revise policies and practices, as necessary. Exclusive concentration on administrative or cost-of-care issues does not fulfill this requirement.

B. The following areas shall be evaluated to identify unacceptable or unexpected trends or occurrences that influence patient outcomes (results of care):

1. Staffing patterns and clinical performance;

2. Admissions and discharges;

3. Supervision appropriate to the level of service;

4. Emergency preparedness plan;

5. Medical records;

6. Appropriateness and effectiveness of pain management;

7. Patient satisfaction and complaint resolution;

8. Infection control;

9. Staff concerns; and

10. Provision of services appropriate to patient needs.

C. The administrator or governing body shall designate a quality improvement committee, which is responsible for the oversight and supervision of the quality improvement program. The committee shall consist of:

1. A physician with association with the hospice program;

2. A member of the administrative staff;

3. Representatives of each of the services provided by the hospice program, including contracted services; and

4. An individual with demonstrated ability to represent the rights and concerns of patients. The individual may be a member of the hospice program's staff, a patient, or a patient's family member.

In selecting members of this committee, consideration shall be given to a candidate's abilities and sensitivity to issues relating to confidentiality, quality of care and services provided to hospice patients.

D. Measures shall be implemented to resolve important problems or concerns that have been identified. Health care practitioners, as well as administrative staff, shall participate in the resolution of the problems or concerns that are identified.

E. Results of the quality improvement program shall be reported annually in writing to the governing body and the administrator, and to the staff as appropriate. The report shall be acted upon by the governing body and the hospice program. All corrective actions shall be documented.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005.

12VAC5-391-270 Infection control

A. The hospice program shall implement a program to reduce the risk of infection.

B. Infection control activities shall include, but are not limited to:

1. Staff, patient, patient family or caregiver education regarding infection risk-reduction behaviors;

2. Use of universal precautions;

3. Handling, storing, processing and transporting of regulated medical waste according to applicable procedures;

4. Handling, storing, processing and transporting supplies and equipment in a manner that prevents the spread of infection; and

5. Monitoring of staff performance of infection control practices.

C. Accumulated waste, including all contaminated sharps, dressings, or similar infectious waste, shall be disposed of in a manner compliant with the OSHA Bloodborne Pathogens standard (29 CFR 1910.1030).

D. Dedicated hospice facilities shall have provisions for isolating patients with infectious diseases.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005.

12VAC5-391-280 Medical record system

A. The hospice program shall maintain an organized medical record system according to accepted standards of practice. Written policies and procedures shall specify retention, reproduction, access, storage, content, and completion of the record.

B. Medical record information shall be safeguarded against loss or unauthorized use.

C. Medical records shall be confidential. Only authorized personnel shall have access as specified in state and federal law.

D. Provisions shall be made for the safe storage of the original record and for accurate and legible reproductions of the original.

E. Policies shall specify arrangements for retention and protection of records if the hospice program discontinues operation and shall provide for notification to the OLC and the patient of the location of the records.

F. An accurate and complete medical record shall be maintained for each patient receiving services and shall include, but shall not be limited to:

1. Patient identifying information;

2. Identification of the attending physician;

3. Admitting information, including a patient history;

4. A psychosocial and spiritual assessment, including information regarding composition of the household, safety issues in the physical environment, coping skills of the family and the patient, and identification of the individuals to be instructed in the care of the patient;

5. Physical assessment;

6. Documentation and results of all medical tests ordered by the physician or other health care professionals and performed by the hospice program's staff;

7. Physician's orders;

8. The plan of care including, but not limited to, the type and frequency of each service to be delivered by hospice program or contract service personnel and appropriate assessment and management of pain;

9. Medication sheets that include the name, dosage, frequency of administration, route of administration, date started, changed or discontinued for each medication, and possible side effects;

10. Copies of all summary reports sent to the attending physician;

11. Documentation of patient rights review;

12. Services provided, including any volunteer services; and

13. A discharge summary that includes continuing symptom management needs.

G. Signed and dated progress notes by each individual delivering service shall be written on the day the service is delivered and incorporated in the medical record within seven working days.

H. All services provided to the patient by the hospice program shall be documented in the patient's medical record.

I. Entries in the medical record shall be current, legible, dated and authenticated by the person making the entry. Errors shall be corrected by striking through and initialing.

J. Verbal orders shall be documented within 24 hours in the medical record by the health care professional receiving the order and shall be countersigned by the health professional initiating the order according to the procedures of the hospice program.

K. Originals or reproductions of individual patient medical records shall be maintained in their entirety for a minimum of five years following discharge or date of last contact unless otherwise specified by state or federal requirements. Records of minors shall be kept for at least five years after the minor reaches 18 years of age.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008.

12VAC5-391-290 Discharge

A. Patients shall receive five days oral and written notice of a transfer or discharge initiated by the hospice program except under the following circumstances:

1. When a medical emergency exists;

2. For the welfare of the patient or the welfare of employees; or

3. The welfare of other patients in a dedicated hospice facility operated by the hospice program.

B. The hospice program shall make all arrangements necessary to assure continuing care and services including a discharge summary for the receiving hospice or provider.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005.

Article 1 Hospice Services

12VAC5-391-300 Hospice services

Article 1 Hospice Services

A. Each hospice shall provide a coordinated program of services encompassing the hospice philosophy that:

1. The unit of care consists of the patient, the primary caregiver, and the patient's family;

2. Emphasizes in-home care;

3. A designated interdisciplinary group supervises the patient's care;

4. A patient's symptoms and physical pain will be appropriately assessed and managed;

5. Services are available 24 hours a day, 7 days a week;

6. Inpatient care is provided in an atmosphere as home-like as practical;

7. Bereavement services are available to the family after the death of the patient; and

8. Trained volunteers are utilized to perform specific job functions in the hospice service delivery system.

B. Specific services provided according to the plan of care shall include:

1. Nursing services;

2. Counseling services;

3. Medical social services;

4. Physician services;

5. Physical therapy, occupational therapy, speech-language pathology;

6. Home attendant services;

7. Short-term inpatient care; and

8. Medical appliances and supplies, including drugs and biologicals, relevant to the patient's terminal illness.

C. There shall be a written transfer agreement with one or more hospitals sufficiently close to the hospice's service area to permit the transfer of patients if medical complications arise. Such agreement shall include, but is not limited to, interagency communication processes and coordination of the patient's plan of care, and shall clearly identify the services to be provided by each entity while the patient is at the hospital.

D. Provisions shall be made to obtain appropriate transportation in cases of emergency.

E. All prescription drugs shall be prescribed and properly dispensed to patients according to the provisions of Chapters 33 (§ 54.1-3300 et seq.) and 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia and the regulations of the Virginia Board of Pharmacy, except for the prescription drugs authorized by § 54.1-3408 of the Drug Control Act, such as epinephrine for emergency administration, normal saline and heparin flushed for the maintenance of IV lines, and adult immunizations, which may be given by a nurse pursuant to established protocol.

F. The hospice program shall have an active program designed to prevent the occurrence of pressure sores or decubitis ulcers by the program's hospice clients.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 27, Issue 11, eff. March 2, 2011.

12VAC5-391-310 Interdisciplinary group or IDG

A. The hospice program shall designate an interdisciplinary group or groups to provide or supervise the care and services offered by the hospice program. The IDG shall consist of:

1. The patient, the patient's primary caregiver, and patient's family;

2. The attending physician;

3. The medical director;

4. A registered nurse;

5. The social worker;

6. The pastoral or other counselor; and

7. Volunteers, if applicable.

B. The IDG shall:

1. Establish a coordinated plan of care for the services, supplies and medical appliances required for each patient;

2. Provide or supervise the care and services delivered; and

3. Periodically reassess each patient and update the patient's plan of care, as needed.

C. The IDG shall establish policies governing the day-to-day provision of the care and services. If the hospice program utilizes multiple IDGs, one IDG shall be designated in advance as responsible for establishing those policies.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005.

12VAC5-391-320 Plan of care

A. At the time of a patient's admission to the hospice program, the IDG shall develop and maintain a plan of care, including but not limited to:

1. Identification of the primary caregiver, or an alternative in the absence of a primary caregiver, to ensure the patient's needs will be met;

2. The patient's diagnosis and prognosis;

3. Assessment of the patient's family medical, physical, psychosocial, spiritual and bereavement needs, identification of the services required to meet those needs and plans for providing the services through the IDG, contractual providers, and community resources;

4. A comprehensive assessment of pain, as warranted by the patient's condition and the scope of services provided by the hospice program;

5. Services to be provided, including (i) specific procedures, (ii) treatment modalities, and (iii) frequency and duration of the services ordered;

6. Special dietary or nutritional needs, when applicable;

7. Medical equipment, supplies, medications, and specialized therapies when applicable;

8. Identification of the members of the staff designated to carry out the plan of care; and

9. Physician orders, including any orders to change the plan when appropriate.

B. Services shall be provided according to the patient's plan of care. The plan of care shall be updated at intervals determined by the IDG and specified in the plan.

C. The plan of care shall be reviewed, approved and signed by the patient's attending physician or the hospice program's medical director after consultation with the patient's attending physician.

D. The attending physician shall be notified immediately of any changes in the patient's condition that indicates a need to alter the plan of care.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005.

12VAC5-391-330 Medical direction

A. There shall be a medical director, who shall be a physician licensed by the Virginia Board of Medicine, responsible for the overall direction and management of the medical component of care. The individual shall have training and experience in the psychological and medical needs of the terminally ill.

B. The duties and responsibilities of the medical director shall include at least the following:

1. Consulting with attending physicians regarding pain and symptom management;

2. Reviewing patient eligibility for hospice services according to the law and the hospice program's admission policies;

3. Acting as a medical resource to the IDG;

4. Coordinating with attending physicians to assure a continuum of medical care in cases of emergency or in the event the attending physician is unable to retain responsibility for the patient's care;

5. Acting as medical liaison with physicians in the community; and

6. Determining, in consultation with the patient's physician, when a patient can no longer remain at home and should be moved to a congregate living facility of the patient's choosing.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 37, Issue 14, eff. April 15, 2021.

12VAC5-391-340 Nursing services

A. All nursing services shall be provided directly or under the supervision of a registered nurse, currently licensed by the Virginia Board of Nursing, who has education and experience in the needs of the terminally ill. Duties and responsibilities of the supervising nurse shall include:

1. Assuring that nursing services delivered are provided according to established hospice program policies;

2. Assuring that nursing services are available 24 hours a day, 7 days a week and that licensed practical nurses and home attendants work under the direct supervision of a registered nurse;

3. Participating in the development and implementation of orientation and in-service training hospice programs for all levels of nursing staff employed by the hospice program;

4. Acting as nurse liaison with staff and other agencies, hospice programs and individuals that have contractual agreements to provide nursing services;

5. Participating in quality improvement reviews and evaluations of the nursing services provided; and

6. Directing or supervising the delivery of nursing services.

B. Nursing services shall include:

1. Assessing a patient's needs and admission for service as appropriate;

2. Working with the IDG to develop a plan of care;

3. Implementing the plan of care;

4. Obtaining physician's orders when necessary;

5. Providing those services requiring substantial and specialized nursing skill;

6. Educating the patient and patient's family in the care of the patient, including pain management;

7. Evaluating the outcome of services;

8. Coordinating and communicating the patient's physical or medical condition to the IDG;

9. Preparing clinical notes; and

10. Supervising licensed practical nurses and home attendants providing delegated nursing services.

C. A registered nurse shall coordinate the implementation of each patient's plan of care.

D. If nursing duties are delegated, the hospice program shall develop and implement an organizational plan pursuant to 18VAC90-19-240 through 18VAC90-19-280.

E. Licensed practical nurses shall be currently licensed by the Virginia Board of Nursing.

F. The services provided by a licensed practical nurse may include:

1. Delivering nursing services according to the hospice program's policies and standard nursing practices;

2. Assisting the registered nurse in performing specialized procedures;

3. Assisting the patient with activities of daily living, including the teaching of self-care techniques;

4. Preparing equipment and supplies for treatment that requires adherence to sterile or aseptic techniques; and

5. Preparing clinical notes.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 37, Issue 14, eff. April 15, 2021.

12VAC5-391-350 Home attendant services

A. Services of the home attendants may include:

1. Assisting patients with (i) activities of daily living; (ii) ambulation and prescribed exercise; (iii) other special duties with appropriate training and demonstrated competency;

2. Administration of normally self-administered drugs in a patient's private residence as allowed by § 54.1-3408 of the Virginia Drug Control Act (Chapter 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia);

3. Taking and recording vital signs as indicated in the plan of care;

4. Measuring and recording fluid intake and output;

5. Recording and reporting to the health care professional changes in the patient's physical condition, behavior or appearance;

6. Documenting services and observations in the medical record; and

7. Performing any other duties that the attendant is qualified to do by additional training and demonstrated competency, within state guidelines.

B. Prior to the initial delivery of services, the home attendant shall receive specific written instructions for the patient's care from the appropriate health care professional responsible for the care.

C. Home attendants shall work under the supervision of the appropriate health care professional responsible for the patient's care.

D. The nurse responsible for supervising the home attendant shall make visits to the patient's home as frequently as necessary, but not less than every two weeks. The results of each visit shall be documented in the medical record.

E. Relevant in-service education or training for home attendants shall consist of at least 12 hours annually. In-service training may be in conjunction with on-site supervision.

F. Home attendants shall be able to speak, read and write English and shall meet one of the following qualifications before providing services to the hospice program's patients:

1. Have satisfactorily completed a nursing education hospice program preparing for registered nurse licensure or practical nurse licensure;

2. Have satisfactorily completed a nurse aide education hospice program approved by the Virginia Board of Nursing;

3. Have certification as a nurse aide issued by the Virginia Board of Nursing;

4. Be successfully enrolled in a nursing education hospice program preparing for registered nurse or practical nurse licensure and have currently completed at least one nursing course that includes clinical experience involving patient care; or

5. Have satisfactorily passed a competency evaluation that meets the criteria of 42 CFR 484.36 (b).

If the home attendant is a volunteer, the home attendant shall meet one of the qualifications listed in subdivisions 1 through 5 of this subsection or have satisfactorily completed training provided by a hospice program or other entity that meets the requirements of subsection G.

G. Hospice programs may develop a 40-hour training program for volunteers. The program shall:

1. Include education addressing:

a. Goals of personal care;

b. Prevention of skin breakdown;

c. Physical and biological aspects of aging;

d. Physical and emotional needs of older adults;

e. Orientation to types of physical disabilities;

f. Personal care and rehabilitative services;

g. Body mechanics;

h. Home management;

i. Safety and accident prevention in the home;

j. Policies and procedures regarding accidents or injuries;

k. Food, nutrition, and meal preparation;

l. Special considerations in preparation of special diets;

m. Care of the home and personal belongings; and

n. Documentation requirements for Medicaid individuals.

2. Be conducted by a registered nurse who meets the requirements in 18VAC90-26-30.
3. Issue and maintain certificates of completion containing:

a. The instructor's printed name and signature;

b. The participant's printed name; and

c. The date of completion of the program.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 28, Issue 4, eff. November 23, 2011; amended, Virginia Register Volume 37, Issue 14, eff. April 15, 2021.

12VAC5-391-360 Medical social services

A. Social services shall be provided according to the plan of care under the direction of a qualified social worker who holds, at a minimum, a bachelor's degree with major studies in social work, sociology, or psychology from a four-year college or university accredited by the Council on Social Work Education and has at least two years experience in case work or counseling in a health care or social services delivery system.

The hospice program has one year from the effective date of this chapter to ensure the designated individual meets the qualifications of this standard.

B. The duties of the social worker may include, but are not limited to:

1. Conducting a complete psychosocial assessment of the patient and family and participating in the development of the plan of care at the time of the patient's admission;

2. Delivering or supervising the delivery of social services to the patient or the patient's family;

3. Reviewing and updating the plan of care as often as necessary;

4. Obtaining physician's orders for services, as necessary;

5. Assisting the patient and family with identifying and accessing community resources;

6. Reporting any changes in the emotional, social, or financial condition of the patient or family to the attending physician;

7. Acting as consultant to hospice program staff;

8. Participating in the quality improvement reviews and evaluation of social services;

9. Preparing clinical notes; and

10. Participating in discharge planning.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005.

12VAC5-391-370 Spiritual counseling and bereavement services

A. The hospice program shall provide for the delivery of spiritual counseling and bereavement services that reflect the family's needs and desires and are delivered according to the overall plan of care.

B. Spiritual counseling may be provided through a working arrangement with individual clergy, clergy associations, and other religious programs in the community or by clergy employed by the hospice program.

C. The hospice program shall provide bereavement services to the family for a minimum of one year after the patient's death.

D. The hospice program shall maintain a list of individuals who provide spiritual and bereavement services. The list shall be made available upon request to patients, families, hospice program employees, and contractors.

E. Arrangements for and delivery of spiritual counseling and bereavement services shall be documented in the patient's record.

F. During a declared public health emergency related to a communicable disease of public health threat, each hospice facility shall establish a protocol to allow patients to receive visits from a rabbi, priest, minister, or clergy member of a religious denomination or sect. Such protocol shall be consistent with guidance from the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services and subject to compliance with an executive order, order of public health, department guidance, or other applicable federal or state guidance having the effect of limiting visitation.

1. The protocol may restrict the frequency and duration of visits and may require visits to be conducted virtually using interactive audio or video technology.

2. The protocol may require the person visiting a patient pursuant to this subsection to comply with all reasonable requirements of the hospice facility adopted to protect the health and safety of the person, patients, and staff of the hospice program.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 41, Issue 17, eff. May 22, 2025.

12VAC5-391-380 Dietary or nutritional counseling

Dietary or nutritional counselors shall meet the requirements of Chapter 27.1 (§ 54.1-2730 et seq.) of Title 54.1 of the Code of Virginia and have at least two years experience in a health care food or nutrition delivery system.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 37, Issue 14, eff. April 15, 2021.

12VAC5-391-390 Therapy services

A. Physical therapy, occupational therapy, or speech therapy services shall be provided under the direction of an appropriately qualified therapist licensed or certified as required in Virginia. The therapy services provided may include, but are not limited to:

1. Assessing patient needs;

2. Participating, as necessary, in developing a patient's plan of care;

3. Implementing therapy services as documented in a patient's plan of care;

4. Evaluating the outcome of the services provided;

5. Educating the patient and family regarding the therapy services provided;

6. Providing therapy service consultation to other health care professionals;

7. Coordinating and communicating with the IDG regarding changes in the patient's needs;

8. Supervising therapy assistants and home attendants as appropriate;

9. Preparing clinical notes; and

10. Obtaining physician orders, when necessary.

B. The occupational therapy assistant shall practice under the supervision of a licensed occupational therapist.

C. The physical therapy assistant shall be currently licensed by the Virginia Board of Physical Therapists and shall practice under the supervision of a licensed physical therapist.

D. Duties of therapy assistants shall include, but are not limited to:

1. Performing services planned, delegated, and supervised by the appropriately licensed or certified therapist; and

2. Preparing clinical notes.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005.

12VAC5-391-395 Medication errors and drug reactions

A. In the event of a medication error or adverse drug reaction, employees shall promptly notify the patient's physician, the medical director, the nurse and the patient's family and shall take action as directed. Adverse outcomes of medication errors or drug reactions shall also be reported to the OLC within 48 consecutive hours of the event.

B. Actions taken shall be documented in the patient's record.

C. The hospice program shall review all medication errors at least quarterly as part of its quality assurance program.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 27, Issue 11, eff. March 2, 2011.

12VAC5-391-400 Volunteer services

A. The hospice program shall utilize trained volunteers to provide patient care, including the activities of daily living, and family support.

B. The hospice program shall have a plan delineating training, responsibilities, and supervision of all volunteers.

C. The hospice program shall demonstrate evidence of ongoing continuing education and recruitment activities for volunteers.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005.

Article 2 Other Special Services

12VAC5-391-410 Other special services

Article 2 Other Special Services

A. Other special services may be offered at the option of the hospice program and may include, but are not limited to:

1. Respiratory therapy; and

2. Pharmacy therapy.

B. Special services may be provided by hospice program employees or through contractual arrangements with individuals or programs that are licensed or certified as required by law.

C. A patient's need for special services shall be documented in the plan of care prepared by the IDG.

D. The special service provider shall assess the patient's need, assist in the development of the plan of care, and provide services according to the plan of care.

E. The special service provider shall participate in the review and update of the plan of care.

F. The special service provider shall instruct the patient, family members, and hospice staff, as appropriate, in assisting with the treatments.

G. Special services provided shall be documented in the medical record.

H. The special service provider shall provide consultative services and in-service training to hospice program staff as needed.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005.

12VAC5-391-420 Respiratory therapy

Respiratory therapy services shall be provided by a respiratory therapist licensed in Virginia. The duties of the respiratory therapist shall include:

1. Assessing patient needs;

2. Participating with the IDG in developing a plan of care;

3. Implementing a plan of care and revising as necessary;

4. Evaluating the outcome of the care provided;

5. Educating the patient and family;

6. Providing consultation to other health care professionals;

7. Coordinating and communicating with the IDG regarding changes in the patient's needs;

8. Preparing clinical notes; and

9. Obtaining physician orders, when necessary.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005.

12VAC5-391-430 Pharmacy services

A. All prescription drugs shall be prescribed and properly dispensed to the patient according to the provisions of Chapters 33 (§ 54.1-3300 et seq.) and 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia and the regulations of the Virginia Board of Pharmacy, except for prescription drugs authorized by § 54.1-3408 of the Drug Control Act, such as epinephrine for emergency administration, normal saline and heparin flushes for the maintenance of IV lines, and adult immunizations, which may be given by a nurse pursuant to established protocol.

B. Home attendants may administer normally self-administered drugs in the patient's private residence as allowed by § 54.1-3408 of the Virginia Drug Control Act (Chapter 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia). Any other drug shall be administered only by a licensed nurse or physician assistant.

C. The hospice program shall develop written policies and procedures for the administration of infusion therapy medications that include:

1. Developing a plan of care;

2. Initiation of medication administration based on a prescriber's order and monitoring of the patient for response to the treatment and any adverse reactions or side effects;

3. Assessment of any factors related to the home environment that may affect the prescriber's decisions for initiating, modifying, or discontinuing medications;

4. Communication with the prescriber concerning assessment of the patient's response to therapy, any other patient specific needs, any significant change in the patient's condition;

5. Communication with the patient's provider pharmacy concerning problems or needed changes in a patient's medication;

6. Maintaining a complete and accurate record of medications prescribed, medication administration data, patient assessments, any laboratory tests ordered to monitor response to drug therapy and results, and communications with the prescriber and pharmacy provider;

7. Educating or instructing the patient, family members, or other caregivers involved in the administration of infusion therapy in the proper storage of medication, in the proper handling of supplies and equipment, in any applicable safety precautions, in recognizing potential problems with the patient, and actions to take in an emergency; and

8. Initial training and retraining of all hospice program staff providing infusion therapy.

D. The hospice program shall employ a registered nurse who holds a current active license with the Virginia Board of Nursing, has completed training in infusion therapy and has the knowledge, skills, and competencies to safely administer infusion therapy to supervise medication administration by staff. This person shall be responsible for ensuring compliance with applicable laws and regulations, adherence to the policies and procedures related to administration of medications, and conducting periodic assessments of staff competency in performing infusion therapy.

E. Hospice and hospice facility employees who are authorized to possess, distribute, or administer medications to patients may store, dispense, or administer cannabidiol oil or THC-A oil to a patient who has:

1. Been issued a valid written certification for the use of cannabidiol oil or THC-A oil in accordance with subsection B of § 54.1-3408.3 of the Code of Virginia; and

2. Registered with the Board of Pharmacy.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 28, Issue 4, eff. November 23, 2011; Volume 36, Issue 23, eff. August 6, 2020.

12VAC5-391-440 General facility requirements

A. All construction of new buildings and additions, renovations or alterations of existing buildings for occupancy as a hospice facility shall conform to state and local codes, zoning and building ordinances, and the Uniform Statewide Building Code.

In addition, hospice facilities shall be designed and constructed according to Part 1, Part 2, and Chapter 3.2 of Part 3 of the Guidelines for Design and Construction of Residential Health, Care, and Support Facilities, 2022 Edition (The Facility Guidelines Institute), as amended by the December 2023 Errata for Guidelines for Design and Construction of Residential Health, Care, and Support Facilities, 2022 Edition (The Facility Guidelines Institute).

B. All buildings shall be inspected and approved as required by the appropriate regional state fire marshal's office or building and fire regulatory official. Approval shall be a Certificate of Use and Occupancy indicating the building is classified for its proposed licensed purpose.

C. The facility shall have space for private patient family visiting and accommodations for family members after a patient's death. Patients shall be allowed to receive guests, including small children, at any hour.

D. Patient rooms shall not exceed two beds per room and must be at grade level or above, enclosed by four ceiling-high walls. Each room shall be equipped for adequate nursing care, the comfort and privacy of patients, and with a device for calling the staff member on duty.

E. Designated guest rooms for a patient's family members or guests and beds for use by employees of the facility shall not be included in the bed capacity of a hospice facility, provided such beds and locations are identified and used exclusively by staff, volunteers, or patient guests.

An employee may not utilize patient rooms and patients may not use bedrooms for employees.

F. Waste storage shall be located in a separate area outside or easily accessible to the outside for direct pickup or disposal. The use of an incinerator shall require permitting from the nearest regional permitting office for the Department of Environmental Quality.

G. The facility shall provide or arrange for under written agreement, laboratory, x-ray, and other diagnostic services, as ordered by the patient's physician.

H. There shall be a plan implemented to ensure the continuation of essential patient support services in case of power outages, water shortage, or in the event of the absence from work of any portion of the workforce resulting from inclement weather or other causes.

I. No part of a hospice facility may be rented, leased, or used for any purpose other than the provision of hospice care at the facility.

J. A separate and distinct entrance shall be provided if the program intends to administer and provide its community-based hospice care from the facility so that such traffic and noise shall be diverted away from patient care areas.

K. The hospice facility shall maintain a complete set of legible "as built" drawings showing all construction, fixed equipment, and mechanical and electrical systems, as installed or built.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 27, Issue 11, eff. March 2, 2011; Volume 37, Issue 14, eff. April 15, 2021; Volume 42, Issue 16, eff. May 7, 2026.

12VAC5-391-445 Additional building regulations and standards

A. Water shall be obtained from an approved water supply system. Hospice facilities shall be connected to sewage systems approved by the Department of Health or the Department of Environmental Quality.

B. Each hospice facility shall establish a monitoring program for the internal enforcement of all applicable fire and safety laws and regulations.

C. The hospice facility's food services shall comply with 12VAC5-421, as applicable.

D. A hospice facility's pharmacy services shall comply with Chapters 33 (§ 54.1-3300 et seq.) and 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia and 18VAC110-20.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 27, Issue 11, eff. March 2, 2011.

12VAC5-391-446 Financial controls and patient funds

A. All financial records, including resident funds, shall be kept according to generally accepted accounting principles.

B. Hospice facilities choosing to handle patient funds shall, upon receipt of a patient's written delegation of this responsibility:

1. Give the patient at least a quarterly accounting of financial transactions made on his behalf and shall permit the patient access to the records of financial transactions made on his behalf at least once a month;

2. Purchase a surety bond or otherwise provide assurance for the security of all personal funds deposited with the facility; and

3. Provide for separate accounting of patient funds.

C. In the event the hospice facility is sold, the provider shall verify that all patient funds have been transferred or returned to the patient and shall obtain a signed receipt from the new owner of all patient funds transferred. Upon receipt, the new owner shall provide an accounting of resident funds transferred to the respective patient.

D. When a patient with funds deposited with the facility leaves or is discharged, the facility shall give a final accounting, within 30 days, of those funds to the patient or the individual administering the patient's estate and, if appropriate, refund any money due.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 27, Issue 11, eff. March 2, 2011.

12VAC5-391-450 Required staffing

A. There shall be an individual, designated in writing, responsible for the day-to-day management and operation of the hospice facility. Such individual shall report directly to the program administrator and shall be qualified to perform the duties identified in 12VAC5-391-180 C.

B. The facility shall provide 24-hour nursing services sufficient to meet the total nursing needs of its patients according to individual plans of care, including treatments, medication, and diet as prescribed, and shall keep patients comfortable, clean, well-groomed, and protected from avoidable accidents, injuries, and infections.

C. The hospice facility shall have a sufficient number of trained and supervised staff to meet the needs of each patient. At least two staff, one of which is a licensed nurse, must be on duty when patients are present. However, facilities with six or fewer beds may staff with a single licensed nurse provided compliance with subsection B of this section is maintained.

If the nurse on duty is not a registered nurse, then a registered nurse must be on call and able to respond to emergent calls within 20 minutes.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 27, Issue 11, eff. March 2, 2011.

12VAC5-391-460 Pharmacy services

A. Whether medications and biologicals are obtained from community or institutional pharmacies, the hospice facility is responsible for assuring availability for medications and biologicals, including 24-hour emergency services, for its patients and for ensuring that pharmaceutical services are provided according to accepted professional principles and appropriate federal and state laws.

B. The facility shall comply with the Virginia Board of Pharmacy regulations related to pharmacy services in long-term care facilities (i.e., Part XII (18VAC110-20-520 et seq.) of the Regulations Governing the Practice of Pharmacy).

C. Each hospice facility shall develop and implement policies and procedures for the handling of drugs and biologicals, including procurement, storage, administration, medication errors, self-administration, disposal and accounting of drugs and other pharmacy products.

D. Each facility shall have a written agreement with a qualified pharmacist to provide consultation on all aspects of the provision of pharmacy services in the facility.

The consultant pharmacist shall make regularly scheduled visits, at least quarterly, to the facility for a sufficient number of hours to carry out the function of the agreement.

E. Each prescription container shall be individually labeled by the pharmacist for each patient or provided in an individualized unit dose system.

F. No drug or medication shall be administered to any patient without a valid verbal order or a written, dated and signed order from a physician, dentist, podiatrist, nurse practitioner, or physician assistant licensed in Virginia.

G. Verbal orders for drugs or medications shall only be given to a licensed nurse, pharmacist or physician.

H. Each patient's medication regimen shall be reviewed by a pharmacist licensed in Virginia. Any irregularities identified by the pharmacist shall be reported to the physician and the director of nursing, and their response documented.

I. Medication orders shall be reviewed at least every 60 days by the attending physician, nurse practitioner, or physician's assistant.

J. Prescription and nonprescription drugs and medications may be brought into the facility by a patient's family, friend, or other person provided:

1. The individual delivering the drugs and medications assures timely delivery, in accordance with the facility's written policies, so that the patient's prescribed treatment plan is not disrupted;

2. Each drug or medication is in an individual container; and

3. Delivery is not allowed directly to an individual patient.

In addition, prescription medications shall be:

4. Obtained from a pharmacy licensed by the state or federal authority; and

5. Securely sealed and labeled by a licensed pharmacist according to 18VAC110-20-330 and 18VAC110-20-340.

K. Any hospice licensed by the Department of Health or exempt from licensure pursuant to § 32.1-162.2 of the Code of Virginia with a hospice patient residing at home at the time of death shall notify every pharmacy that has dispensed partial quantities of a Schedule II controlled substance for a patient with a medical diagnosis documenting a terminal illness, as authorized by federal law, within 48 hours of the patient's death.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 27, Issue 11, eff. March 2, 2011; Volume 32, Issue 14, eff. April 7, 2016.

12VAC5-391-470 Restraints

A. Periodic or continuous mechanical or physical restraints during routine care of a patient shall not be permitted, nor shall patients be restrained for employee convenience or as a substitute for care, treatment, or services. In cases of extreme emergencies, when a patient is a danger to himself or others, mechanical or physical restraints may be used as ordered by a physician or other health care provider.

B. Only those devices specifically designed as restraints may be used. Makeshift restraints shall not be used under any circumstances.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005.

12VAC5-391-480 Dietary and food service

A. This section is not applicable to family members preparing meals or bringing food into the facility.

B. The facility shall provide dietary services to meet the daily nutritional needs of patients.

C. The hospice facility shall employ sufficient assigned food service personnel trained to provide a hygienic dietary service that meets the daily nutritional and special dietary needs of patients and provides palatable and attractive meals.

D. When meals are catered, such meals shall be obtained from a food service establishment licensed by the Virginia Department of Health. There shall be a current written contract with the food service establishment pursuant to 12VAC5-391-230.

E. The hospice facility shall contract with or employ a consulting registered dietitian, who meets the qualifications of § 54.1-2731 of the Code of Virginia, to provide guidance to the facility's food service personnel on methods for maintaining the dietary service, planning of nutritionally balanced meals, and assessing the dietary needs of individual patients. The dietitian's duties shall include the following:

1. Developing menus, including therapeutic diets prescribed by a patient's physician;

2. Developing, revising, and annually reviewing dietary policies, procedures and job descriptions;

3. Assisting in planning and conducting regularly scheduled inservice training that includes, but is not limited to:

a. Therapeutic diets;

b. Food preparation requirements; and

c. Principles of sanitation.

4. Visiting patients on a regular basis to discuss nutritional problems, depending upon their needs and level of care, and recommending appropriate solutions.

F. Menus shall meet the dietary allowances of the Food and Nutritional Board of the National Academy of Sciences, as adjusted for age, sex, and activity level.

G. A copy of a diet manual containing acceptable practices and standards for nutrition must be kept current and on file in the food preparation area.

H. Food service facilities shall be located in a designated area and shall include the following rooms or spaces:

1. Kitchen;

2. Dishwashing;

3. Food storage; and

4. Dining room.

I. At least three meals, served at regular intervals, shall be provided daily to each patient, unless contraindicated as documented by the attending physician in the patient's medical record.

J. Special attention shall be given to preparation and prompt serving in order to maintain correct food temperatures for serving.

K. Between meal snacks of nutritional value shall be available upon request to each patient according to their plan of care.

L. Therapeutic diets shall be prepared and served as prescribed by the attending physician.

M. Employees assigned to other duties in the facility and visitors shall not be allowed in the food preparation area during food preparation and patient meal service hours, except in cases of emergency.

N. Weekly menus, including therapeutic diets, substitutes, and copies of menus, as served, shall be retained on file for 12 months.

O. Disposable dinnerware or tableware shall be used only for emergencies, for infection control, as part of special activities, or as indicated in a patient's plan of care.

P. For hospice facilities with 13 or more patient beds:

1. The dietary and food service operation shall meet all applicable sections of 12VAC5-421; and

2. There shall be a food service manager, qualified as allowed in 12VAC5-421-60, responsible for the full-time management and supervision of the dietary service.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 27, Issue 11, eff. March 2, 2011.

12VAC5-391-485 Maintenance and housekeeping

A. The hospice facility shall be maintained and equipped to provide a functional, sanitary, safe, and comfortable environment.

B. A documented preventive maintenance program shall be established to ensure that equipment is operative and that the interior and exterior of the building or buildings are maintained in good repair and free from hazards and litter.

C. The administrator shall designate an employee responsible for carrying out these functions and for training and supervising housekeeping and maintenance personnel.

D. The heating, ventilation and air conditioning system shall be capable of maintaining temperatures between 70°F and 80°F throughout patient areas.

E. The hospice facility shall have an effective pest control program either by maintenance personnel or by contract with a pest control company.

F. The hospice facility shall provide adequate space, equipment and supplies for any special services to be offered.

G. All furniture shall be kept clean and safe for use.

H. Over bed tables shall be available as needed.

I. Stretchers and wheelchairs shall be stored out of the path of normal traffic.

J. A sufficient number of wheelchairs and chairs shall be provided for patients whose physical conditions indicate a need for such equipment.

K. Refuse containers shall be emptied and cleaned at frequent intervals.

L. Hazardous cleaning solutions, compounds and substances shall be labeled, stored and kept under lock in a safe place separate from other materials.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 27, Issue 11, eff. March 2, 2011.

12VAC5-391-490 Laundry services

A. A quantity of linens shall be available at all times to provide for proper care and comfort of residents.

B. Linens and other laundry must be handled, stored and processed to control the spread of infection.

C. Clean linen shall be stored in a clean and dry area accessible to patient rooms.

D. Soiled linen shall be stored in covered containers in separate, well-ventilated areas and shall not accumulate in the facility.

E. Soiled linen shall not be sorted, laundered, rinsed or stored in bathrooms, patient rooms, kitchens or food storage areas.

F. Soiled linen shall not be placed on the floor.

G. Arrangement for laundering patient's personal clothing shall be provided. If laundry facilities are not provided on premises, commercial laundry services shall be utilized.

H. Laundry facilities shall include:

1. A soiled laundry receiving, holding, and sorting room with hand-washing lavatory; and

2. A clean laundry storage, issuing, and holding room or area.

I. On-premise laundry service facilities shall include:

1. A laundry processing room with commercial-type equipment capable of processing seven days needs within a regularly scheduled workweek and a hand-washing lavatory;

2. A storage space for laundry supplies; and

3. A clean laundry inspection and mending room or area.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005.

12VAC5-391-495 Transportation

The hospice facility shall assist a patient in obtaining transportation when it is necessary to obtain medical, psychiatric, dental, diagnostic or other services outside the facility.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 27, Issue 11, eff. March 2, 2011.

12VAC5-391-500 Pet care

A. The hospice facility shall implement policies regarding pets, whether the pet is visiting or in residence.

B. The hospice facility shall ensure that any patient's rights, preferences, and medical needs are not compromised by the presence of an animal. Except for working service animals, pets shall not be allowed in dining and kitchen areas when food is being prepared or served.

C. All pets, whether visiting or in residence, shall be in good health, clean and well-groomed, show no evidence of carrying disease, have a suitable temperament, and pose no significant health or safety risks to patients, staff, volunteers, or visitors.

D. For pets in residence, the facility shall:

1. Disclose to potential and current patients the types of pets and the conditions under which pets are allowed in residence;

2. Maintain documentation of disclosure of pet policies in the patients' records;

3. Ensure that, before living in the facility, the pet's owner provides current documentation that the pet has had all recommended or required immunizations;

4. Ensure that regular pet examinations and immunizations are maintained; and

5. Ensure that resident pets are properly cared for and that the pet and its housing or bedding are kept clean.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 27, Issue 11, eff. March 2, 2011.

12VAC5-391-510 Safety and emergency preparedness

A. A written emergency preparedness plan shall be developed, reviewed, and implemented when needed. The plan shall address responses to natural disasters, as well as fire or other emergencies that disrupts the normal course of operations. The plan shall include, but not be limited to:

1. The continuation of essential patient support services in case of power outages, water shortages, or in the event of absences from work of any portion of the workforce resulting from inclement weather or other causes;

2. The preparation of patients for potential or imminent emergencies and disasters;

3. Alerting emergency personnel and sounding alarms;

4. Using, maintaining and operating emergency equipment;

5. Accessing patient emergency medical information;

6. Utilizing community support services;

7. A sheltering plan that addresses, but is not limited to:

a. Sheltering in place as well as off-site relocation arrangements;

b. Implementing evacuation procedures; and

c. A letter of agreement with off-site sheltering locations;

8. A transportation plan including:

a. Agreements with entities for relocating patients;

b. Number and type of vehicles required; and

c. Procedures for providing appropriate medical support and medications during relocation; and

9. A staffing plan for relocated patients, including:

a. The number and type of staff needed to provide appropriate care to relocated patients; and

b. Plans for relocating staff or assuring transportation to the sheltering facility.

B. All staff shall participate in periodic emergency preparedness training.

C. Staff shall have documented knowledge of, and be prepared to implement, the emergency preparedness plan in the event of an emergency.

D. At least one telephone shall be available in each area to which patients are admitted, in each patient room, with additional telephones or extensions as are necessary to ensure availability in case of need.

E. In the event of a disaster, fire, medication error, suspicious death, emergency or any other condition that may jeopardize the health, safety and well-being of patients, the facility shall notify the department of the conditions and status of the patients and the hospice facility as soon as possible, but no later than 24 hours after the incident.

F. The hospice facility shall have a policy on smoking.

History

• Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 27, Issue 11, eff. March 2, 2011.

Chapter 407 Procedures for the Submission of Health Maintenance Organization Quality of Care Performance Information

Part I Definitions and General Information

12VAC5-407-10 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Board" means State Board of Health.

"Commissioner" means the State Health Commissioner.

"Consumer" means any person (i) whose occupation is other than the administration of health activities or the provision of health services; (ii) who has no fiduciary obligation to a health care institution or other health agency or to any organization, public or private, whose principal activity is an adjunct to the provision of health services; or (iii) who has no material financial interest in the rendering of health services.

"Department" means the Virginia Department of Health.

"Health maintenance organization" or "HMO" means any person who undertakes to provide or to arrange for one or more health care plans pursuant to Chapter 43 (§ 38.2-4300 et seq.) of Title 38.2 of the Code of Virginia.

"HEDIS" means the Health Employer Data and Information Set, also known as the Healthcare Effectiveness Data and Information Set, a set of standardized performance measures collected and maintained by the National Committee for Quality Assurance.

"NCQA" means the National Committee for Quality Assurance.

"Nonprofit organization" means a nonprofit, tax-exempt health data organization with the characteristics, expertise, and capacity to execute the powers and duties set forth for such entity in Chapter 7.2 (§ 32.1-276.2 et seq.) of Title 32.1 of the Code of Virginia and that enters into a contract for the compilation, storage, analysis, and evaluation of data pursuant to Chapter 7.2 of Title 32.1.

History

• Statutory Authority: §§ 32.1-12 and 32.1-276.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 26, eff. October 8, 2003; amended, Virginia Register Volume 32, Issue 8, eff. February 1, 2016.

12VAC5-407-20 Applicability

This chapter shall apply to all HMOs with an active license to operate in this Commonwealth.

History

• Statutory Authority: §§ 32.1-12 and 32.1-276.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

Part II Quality of Care Data Reporting

12VAC5-407-30 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 26, eff. October 8, 2003; repealed, Virginia Register Volume 32, Issue 8, eff. February 1, 2016.

12VAC5-407-40 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 26, eff. October 8, 2003; repealed, Virginia Register Volume 32, Issue 8, eff. February 1, 2016.

12VAC5-407-50 Reporting methods and exemption from reporting

A. Every HMO with an active license in the Commonwealth shall be required to submit the HEDIS or any other quality of care or performance information set approved by the board unless granted a written exemption by the commissioner.

B. The following methods shall be used for data submission:

1. If the HMO submits data to NCQA, the commissioner may purchase HEDIS data or any other quality of care or performance information set from NCQA.

2. If the HMO does not submit data to NCQA, or the commissioner elects not to purchase HEDIS data from the NCQA, then the HMO shall submit the performance information sets approved by the board to the nonprofit organization in accordance with the timeframes established in 12VAC5-407-70.

C. An HMO may, in writing, petition the commissioner for an exemption. The commissioner, at his discretion, may grant a waiver from reporting the HEDIS or any other approved quality of care or performance information set. In considering a petition for waiver, the commissioner may give due consideration to the HMO's (i) sample size; (ii) number of covered lives; (iii) length of operating experience in Virginia; (iv) accreditation status with respect to NCQA or other national accrediting organizations; or (v) any other relevant factors he deems appropriate.

D. An HMO that can demonstrate that it does not meet NCQA's minimum sample size requirements to collect statistically valid information on at least 50% of the HEDIS effectiveness of care measures or performance information sets approved by the board shall be exempt from reporting the HEDIS quality of care or performance sets during the reporting period. The HMO shall submit documentation to the commissioner each reporting period to demonstrate that it meets the criteria for obtaining an exemption from reporting.

History

• Statutory Authority: §§ 32.1-12 and 32.1-276.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 26, eff. October 8, 2003; amended, Virginia Register Volume 32, Issue 8, eff. February 1, 2016.

12VAC5-407-60 Audited data required

HMOs shall submit HEDIS or other quality of care or performance information set approved by the board that has been verified by an independent auditing organization with no financial interest in or managerial association with the HMO. The HMO shall submit an audit report with the data.

History

• Statutory Authority: §§ 32.1-12 and 32.1-276.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 26, eff. October 8, 2003; amended, Virginia Register Volume 32, Issue 8, eff. February 1, 2016.

12VAC5-407-70 Process for data submission

A. Before January 1 of each year, the commissioner shall submit to each HMO in writing the process required for data submission, the fee associated with data submission, and the process for obtaining a waiver. HMOs providing HEDIS or any other quality of care or performance information set directly to the nonprofit organization shall submit the data by September 15 of each year.

B. The board shall direct the nonprofit organization to publish annually the quality information data before December 31.

History

• Statutory Authority: §§ 32.1-12 and 32.1-276.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 26, eff. October 8, 2003; amended, Virginia Register Volume 32, Issue 8, eff. February 1, 2016.

12VAC5-407-80 Fees

A. For each HMO required to provide information pursuant to this chapter, the board shall prescribe a reasonable fee to cover the cost of collecting and making available such data. The commissioner may purchase HEDIS data or other quality of care or performance information set on behalf of all the actively licensed HMOs in the Commonwealth that are participating in HEDIS and divide the cost among the HMOs. Each HMO shall pay an equal share of the cost to the board for purchase of the HEDIS data directly from NCQA. The remainder of the cost associated with making the data available shall be divided among the participating HMOs in a tiered format based on the number of enrollees per HMO.

B. Fees described in subsection A of this section shall not exceed $3,000 per HMO per year.

C. The payment of such fees shall be on September 15 of each year or later if determined by an agreement between the board and the nonprofit organization. The nonprofit organization shall be authorized to charge and collect the fees prescribed by the board in subsection A of this section when the data are provided directly to the nonprofit organization. Such fees shall not exceed the amount authorized by the board.

D. The nonprofit organization shall be authorized to charge and collect reasonable fees approved by the board for making available to any individual or entity who requests the HEDIS data or other approved quality of care data; however, the commissioner, the State Corporation Commission, and the Commissioner of Behavioral Health and Developmental Services shall be entitled to receive relevant and appropriate data from the nonprofit organization at no charge.

E. The board shall direct the nonprofit organization to solicit input from the HMO industry to determine relevant and appropriate data that the industry shall receive at no charge.

History

• Statutory Authority: §§ 32.1-12 and 32.1-276.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 26, eff. October 8, 2003; amended, Virginia Register Volume 32, Issue 8, eff. February 1, 2016.

12VAC5-407-90 Late charge

A. A late charge of $25 per working day shall be paid to the board by an HMO that has not received an exemption from the commissioner as provided for in 12VAC5-407-50 and that has not paid the assessed fees by September 15 or later if determined by an agreement between the board and the nonprofit. The late charge may not be assessed until completion of a 30-day grace period for submitting the data.

B. Late charges may be waived by the board, in its discretion, if an HMO can show that an extenuating circumstance exists. Examples of an extenuating circumstance may include, but are not limited to, the installation of a new computerized system, a bankruptcy proceeding, or change of ownership in the HMO.

History

• Statutory Authority: §§ 32.1-12 and 32.1-276.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 26, eff. October 8, 2003; amended, Virginia Register Volume 32, Issue 8, eff. February 1, 2016.

Part III Duties of the Board and the Nonprofit Organization

12VAC5-407-100 Duties of the nonprofit organization

The contract entered into by the board and the nonprofit organization pursuant to Chapter 7.2 (§ 32.1-276.2 et seq.) of Title 32.1 of the Code of Virginia shall provide:

1. The nonprofit organization shall compile, store, and make available to consumers the data submitted by HMOs.

2. The nonprofit organization shall assist the board in developing a summary plan and budget to collect and make available HMO HEDIS or any other quality of care performance information set results for consumers. The nonprofit organization shall present the summary plan and budget on a biennial basis to the board for approval. The commissioner, at his discretion, shall also review the summary plan on a periodic basis to determine its effectiveness.

3. The nonprofit organization shall collect the HEDIS data in the most cost-effective manner available.

4. The nonprofit organization shall prepare a biennial summary plan in identifying the measures selected for reporting. The summary plan shall include:

a. The rationale for selecting each measure to be made available to consumers;

b. The goal of reporting each measure;

c. The cost and benefit of collecting the measures and making them available to consumers; and

d. The scope of dissemination of information in paper or electronic format and the target audience.

5. The nonprofit organization shall prepare a biennial budget that includes a cost-benefit analysis of purchasing HEDIS data from NCQA or obtaining the information performance sets directly from the HMOs.

6. The nonprofit organization shall present the summary plan and budget to the board for review and approval on a biennial basis.

7. The nonprofit organization shall organize, present, and make available to consumers all data required by the board to be reported to the commissioner. This data shall also be available on the nonprofit's website.

History

• Statutory Authority: §§ 32.1-12 and 32.1-276.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 26, eff. October 8, 2003; amended, Virginia Register Volume 32, Issue 8, eff. February 1, 2016.

12VAC5-407-110 Biennial evaluation

A. The board shall evaluate biennially the impact and effectiveness of collecting and making available HEDIS or any other quality of care or performance information set and the appropriateness of the fee structure. This evaluation shall be completed by January 15.

B. As part of the biennial evaluation, the board may consult with the HMOs and the nonprofit organization to determine whether changes should be made to the HEDIS or any other quality of care or performance information set requirements.

History

• Statutory Authority: §§ 32.1-12 and 32.1-276.5 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

12VAC5-407-120 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 26, eff. October 8, 2003; repealed, Virginia Register Volume 32, Issue 8, eff. February 1, 2016.

Chapter 408 Certificate of Quality Assurance of Managed Care Health Insurance Plan Licensees

Part I Definitions and General Information

12VAC5-408-10 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Adverse decision" means a utilization review determination by the utilization review entity that a health service rendered or proposed to be rendered was not or is not medically necessary, when such determination may result in noncoverage of the health service or health services. When the policy, contract, plan, certificate, or evidence of coverage includes coverage for prescription drugs and the health service rendered or proposed to be rendered is a prescription for the alleviation of cancer pain, any adverse decision shall be made within 24 hours of the request for coverage.

"Appeal" means a formal request by a covered person or a provider on behalf of a covered person for reconsideration of a decision, such as a final adverse decision, a benefit payment, a denial of coverage, or a reimbursement for service.

"Basic health care services" means those health care services, as applicable to the type of managed care health insurance plan, described in § 38.2-5800 of the Code of Virginia which are required to be provided, arranged, paid for, or reimbursed by the managed care health insurance plan licensee for its covered persons.

"Board" means the Board of Health.

"Bureau of Insurance" means the State Corporation Commission acting pursuant to Title 38.2 of the Code of Virginia.

"Center" means the Center for Quality Health Care Services and Consumer Protection of the Virginia Department of Health.

"Certificate" means a certificate of quality assurance.

"Complaint" means a written communication from a covered person primarily expressing a grievance. A complaint may pertain to the availability, delivery, or quality of health care services including claims payments, the handling or reimbursement for such services, or any other matter pertaining to the covered person's contractual relationship with the MCHIP.

"Covered person" means an individual residing in the Commonwealth, whether a subscriber, policyholder, enrollee, or member, of a managed care health insurance plan (MCHIP), who is entitled to health services or benefits provided, arranged for, paid for, or reimbursed pursuant to an MCHIP.

"Delegated service entity" means the entity with which an MCHIP licensee contracts to provide one or more of the services listed in 12VAC5-408-320 A for one or more of its MCHIPs, pursuant to and in accordance with the provisions of Part VI (12VAC5-408-320 et seq.) of this chapter, inclusive.

"Department" means the Virginia Department of Health.

"Emergency services" means those health care services as defined in § 38.2-3438 of the Code of Virginia.

"Evidence of coverage" means any certificate, individual or group agreement or contract, or identification card or related document issued in conjunction with the certificate, agreement or contract, issued to a covered person setting out the coverage and other rights to which a covered person is entitled.

"Final adverse decision" means a utilization review determination made by a physician advisor or peer of the treating health care provider in a reconsideration of an adverse decision, and upon which a provider or patient may base an appeal.

"Health care data reporting system" means the state contracted integrated system for the collection and analysis of data used by consumers, employers, providers, and purchasers of health care to continuously assess and improve the quality of health care in the Commonwealth.

"Health care provider" or "provider" has the same meaning ascribed to the term in § 32.1-127.1:03 B of the Code of Virginia.

"Health care services" means services as defined in § 38.2-3438 of the Code of Virginia.

"Health carrier" means an entity as defined in § 38.2-3438 of the Code of Virginia.

"Managed care health insurance plan" or "MCHIP" means an arrangement for the delivery of health care in which a health carrier, as defined in § 38.2-5800 of the Code of Virginia, undertakes to provide, arrange for, pay for, or reimburse any of the costs of health care services for a covered person on a prepaid or insured basis which (i) contains one or more incentive arrangements, including any credentialing requirements intended to influence the cost or level of health care services between the health carrier and one or more providers with respect to the delivery of health care services and (ii) requires or creates benefit payment differential incentives for covered persons to use providers that are directly or indirectly managed, owned, under contract with or employed by the health carrier. Any health maintenance organization as defined in § 38.2-4300 of the Code of Virginia or health carrier that offers preferred provider contracts or policies as defined in § 38.2-3407 of the Code of Virginia or preferred provider subscription contracts as defined in § 38.2-4209 of the Code of Virginia shall be deemed to be offering one or more managed care health insurance plans. For the purposes of this definition, the prohibition of balance billing by a provider shall not be deemed a benefit payment differential incentive for covered persons to use providers who are directly or indirectly managed, owned, under contract with or employed by the health carrier. A single managed care health insurance plan may encompass multiple products and multiple types of benefit payment differentials; however, a single managed care health insurance plan shall encompass only one provider network or set of provider networks.

"Managed care health insurance plan licensee" or "MCHIP licensee" means a health carrier subject to licensure by the Bureau of Insurance and to quality assurance certification by the department under Title 38.2 of the Code of Virginia who is responsible for a managed care health insurance plan in accordance with Chapter 58 (§ 38.2-5800 et seq.) of Title 38.2 of the Code of Virginia.

"Managed care plan" means a health benefit plan, as defined in § 38.2-3407.10:1 of the Code of Virginia, that requires a covered person to use, or creates incentives, including financial incentives, for a covered person to use health care providers managed, owned, under contract with, or employed by the MCHIP licensee.

"Material" means that which has an effective influence or bearing on, or is pertinent to, the issue in question.

"Medical necessity" or "medically necessary" means appropriate and necessary health care services which are rendered for any condition which, according to generally accepted principles of good medical practice, requires the diagnosis or direct care and treatment of an illness, injury, or pregnancy-related condition, and are not provided only as a convenience.

"Nationally recognized accrediting body" means an organization that sets national standards specifically governing healthcare quality assurance processes, utilization review, provider credentialing, as well as other areas covered by this chapter and provides accreditation to managed care health insurance plans pursuant to national standards. The following entities shall be considered nationally recognized accrediting bodies:

1. The American Accreditation HealthCare Commission/URAC;

2. The National Committee for Quality Assurance (NCQA);

3. The Joint Commission on Accreditation of Healthcare Organizations, (JCAHO); and

4. Other nationally recognized accrediting bodies with national standards as described above that are accepted by the department.

"Network" means a group of providers as defined in § 38.2-3438 of the Code of Virginia.

"New provider applicant" means a provider that has submitted a completed credentialing application to an MCHIP licensee.

"Participating provider" means a provider that is managed, under contract with, or employed by an MCHIP licensee and who has agreed to provide health care services to covered persons with an expectation of receiving payments, other than coinsurance, copayments, or deductibles, directly or indirectly from the MCHIP licensee.

"Person" means any individual, aggregate of individuals, association, business, company, corporation, joint-stock company, Lloyds type of organization, other organization, partnership, receiver, reciprocal or inter-insurance exchange, trustee or society.

"Plan of correction" means an MCHIP'S written plan that outlines the action the MCHIP will take to address compliance issues identified during an administrative review or on-site examination conducted by the department.

"Preferred provider organization" or "PPO" means an arrangement in which a health carrier, as defined in § 38.2-5800 of the Code of Virginia, undertakes to provide, arrange for, pay for, or reimburse any of the costs of health care services, on an insured basis, which creates incentives, including financial incentives, for a covered person to use health care providers directly or indirectly managed, owned, under contract with, or employed by the health carrier, but shall not include a health maintenance organization as defined in § 38.2-4300 of the Code of Virginia.

"Quality assurance program" means the systems, standards and processes including, but not limited to, reasonable and adequate systems to assess, measure, and improve the health status of covered persons, necessary to obtain a certificate of quality assurance from the department in accordance with this chapter and in accordance with § 32.1-137.2 C of the Code of Virginia.

"Service area" means a geographic area as defined in § 38.2-5800 of the Code of Virginia.

"Timely" means the provision of services so as not to impair or jeopardize the integrity of the covered persons' diagnosis or outcomes of illness.

"Treating health care provider" means a licensed health care provider who renders or proposes to render health care services to a covered person.

"Utilization review" means a system for reviewing the necessity, appropriateness, and efficiency of hospital, medical or other health care services rendered or proposed to be rendered to a patient or group of patients for the purpose of determining whether such services should be covered or provided by an insurer, health services plan, managed care health insurance plan licensee, or other entity or person. For purposes of this chapter, "utilization review" shall include, but not be limited to, preadmission, concurrent and retrospective medical necessity determination, and review related to the appropriateness of the site at which services were or are to be delivered. "Utilization review" shall not include (i) review of issues concerning insurance contract coverage or contractual restrictions on facilities to be used for the provision of services, (ii) any review of patient information by an employee of or consultant to any licensed hospital for patients of such hospital, or (iii) any determination by an insurer as to the reasonableness and necessity of services for the treatment and care of an injury suffered by an insured for which reimbursement is claimed under a contract of insurance covering any classes of insurance defined in §§ 38.2-117 through 38.2-119, 38.2-124 through 38.2-126, 38.2-130 through 38.2-132 and 38.2-134 of the Code of Virginia.

"Utilization review entity" means a person or entity performing utilization review.

"Utilization review plan" means a written procedure for performing a utilization review.

History

• Statutory Authority: §§ 32.1-12 and 32.1-137.3 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002; Volume 28, Issue 4, eff. November 23, 2011; Volume 37, Issue 14, eff. April 15, 2021.

12VAC5-408-20 Responsibility of the department

A. The Code of Virginia allows the Board of Health to adopt regulations for the certification of quality assurance for managed care health insurance plans licensees. The Department of Health is charged with the responsibility for examining the quality of health care services provided by, arranged for, paid for, or reimbursed by managed care health insurance plan licensees according to regulations adopted by the board and any additional requirements that may be specified by the Code of Virginia. The Center for Quality Health Care Services and Consumer Protection acts as agent for the department for certifying managed care health insurance plans, which includes investigating complaints made against an MCHIP licensee.

B. In developing or revising these regulations, the department adheres to the requirements of the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) and the public participation process. The department solicits input from MCHIPs, associations of MCHIPs, providers, experts in related fields, advocacy organizations, consumers and the general public in the development or revision of this chapter through informal and formal comment periods and public hearings.

C. The department shall coordinate its activities with the Bureau of Insurance to ensure an appropriate level of regulatory oversight and to avoid undue duplication of effort or regulation.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

12VAC5-408-30 Certificate of quality assurance

A. A certificate for quality assurance shall be issued to managed care health insurance plan licensees. The commissioner shall issue or renew a certificate of quality assurance if the MCHIP licensee is in compliance with the applicable law and this chapter. On behalf of the commissioner, and under a written delegation of authority, the department shall examine the applicants and issue the certificates for quality assurance.

B. No certificate of quality assurance may be transferred or assigned without approval of the department.

C. Every certified MCHIP licensee shall file for its certificate of quality assurance with the department biennially, subject to payment of a fee and receipt of all material required by law and this chapter.

D. Upon request, the center will provide an application form for a certificate of quality assurance. The center shall consider the application complete when all the information requested and the application fee are submitted. If the center finds the application incomplete, the applicant will be notified in writing of receipt of the incomplete application.

E. The department shall send an application for renewal of a certificate to the licensee at least 90 days prior to the expiration date of the current certificate.

F. The department shall examine or review each applicant for an initial certificate of quality assurance and periodically for renewal thereof.

G. Upon receipt of a written request from the governing body of an MCHIP licensee, the commissioner, in her sole discretion, may consider a modification and issue a temporary or permanent variance in the application of one or more of these regulations provided patient safety, care, or the ability of an MCHIP licensee to provide, arrange for, or reimburse the cost of services will not be adversely affected. The written request shall identify the reason the MCHIP licensee cannot immediately comply with the specified regulation and how any proposed modification is equal to or will meet the intent of the regulation for which a variance is requested. Upon review of the request, the commissioner may grant a temporary variance for less than a full period of certification, or a permanent variance for a full period of certification, or deny the request. Any temporary or permanent variance granted by the commissioner shall be subject to review and renewal before a certificate renewal, extension or re-issuance is granted.

H. Upon the issuance or renewal of a certificate, the department, on behalf of the commissioner and under a written delegation of authority, shall provide a certificate of quality assurance to the MCHIP licensee and a copy to the Bureau of Insurance.

I. Upon determining to deny or refuse to renew a certificate, the department, on behalf of the commissioner and under a written delegation of authority, shall notify the applicant in writing stating the reasons for the denial of the certificate. A copy of the notification of denial shall be provided to the Bureau of Insurance.

J. Appeals from a notification of denial shall be brought by a certificate applicant pursuant to the process set forth in 12VAC5-408-140.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

12VAC5-408-40 Fees

A. The center shall collect a fee for each initial application and each renewal application. MCHIP licensees with multiple plans wishing to submit a separate application for each plan must include the appropriate fee for each application. Fees shall accompany the application and are not refundable.

B. Fees shall be sufficient to cover reasonable costs for the administration of the quality assurance program.

C. Fees shall be based upon a percentage, not to exceed 1/10 of 1.0%, of the proportion of direct gross premium income on business done in this Commonwealth attributable to the operation of managed care health insurance plans in the preceding biennium not to exceed $10,000 per plan submitted by the licensee for separate certification.

After July 2000, applicants proposing to offer MCHIP plans in the Commonwealth shall be assessed a flat fee of $5,000 for the initial application for a certificate of quality assurance.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

12VAC5-408-50 Compliance provisions appropriate for type of plan

A. Managed care health insurance plan licensees that offer one or more PPO plans as defined in this chapter must require their PPO plans to only comply with the following sections:

1. Parts I (12VAC5-408-10 et seq.) and II (12VAC5-408-160 et seq.) of this chapter;

2. Part III (12VAC5-408-220 et seq.) of this chapter except for subdivision 1 of 12VAC5-408-220 and subdivisions 2 and 10 of 12VAC5-408-240;

3. 12VAC5-408-260 through 12VAC5-408-280 of this chapter except subsection E of 12VAC5-408-260, subsections D and E of 12VAC5-408-270 and subsection G of 12VAC5-408-280; and

4. Parts VI (12VAC5-408-320 et seq.) and VII (12VAC5-408-360) of this chapter.

The MCHIP licensee may comply with 12VAC5-408-170, 12VAC5-408-200, as well as subdivisions A 2 through A 4 of this section, by demonstrating it operates a PPO plan in conformity with the standards of a nationally recognized accrediting body applicable to preferred provider organizations and acceptable to the department. While such demonstration shall be considered reasonable and adequate compliance for purposes of initial and renewal MCHIP certification, the department may employ a checklist to identify and determine compliance with specific statutory or regulatory requirements that are more stringent than the nationally recognized accrediting body standards.

B. Managed care health insurance plan licensees other than PPO plans, including health maintenance organizations, must comply with this entire chapter. The MCHIP licensee may comply with 12VAC5-408-170, 12VAC5-408-200, 12VAC5-408-210, as well as Parts III through VII (12VAC5-408-220 through 12VAC5-408-360) of this chapter by demonstrating that the MCHIP licensee operates in conformity with the standards of a nationally recognized accrediting body that are appropriate for the type of MCHIP corresponding to the licensee and acceptable to the department. Such demonstration shall be considered reasonable and adequate compliance for purposes of initial and renewal MCHIP certification. Nothing in the preceding sentences shall preclude the department from imposing further requirements if the regulatory requirements are more stringent than the nationally recognized accrediting body's standards.

C. Accreditation by a nationally recognized accrediting body shall satisfy the department in demonstrating that the MCHIP licensee operates in conformity with the standards of a nationally recognized accrediting body as permitted under subsection A or B of this section, provided the MCHIP licensee follows the provisions of 12VAC5-408-100 to be eligible for exemption from examination. Otherwise, an MCHIP that is not accredited shall be subject to the triennial comprehensive onsite examination requirements of 12VAC5-408-90. Nothing in the preceding sentences shall preclude the department from imposing further requirements if the regulatory requirements are more stringent than the nationally recognized accrediting body's standards.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

12VAC5-408-60 General examination process

A. The commissioner shall cause MCHIP licensees to be examined or reviewed by the department according to Article 1.1 (§ 32.1-137.1 et seq.) of Chapter 5 of Title 32.1 of the Code of Virginia to:

1. Verify that an MCHIP qualifies for an initial or renewal certificate of quality assurance;

2. Investigate a complaint filed against an MCHIP licensee;

3. Determine compliance with this chapter and applicable law; and

4. Determine if the MCHIP licensee has successfully implemented corrective action following an examination, or as a result of disciplinary action or sanction.

B. Examinations may be conducted onsite at an MCHIP licensee's office and at the site of any delegated service provider. At its discretion, the department may choose to conduct an administrative review to evaluate the MCHIP for compliance with applicable law and this chapter. The MCHIP's examination may also include contractors with whom the licensee has agreements, contracts, or other arrangements to provide health care services for the MCHIP.

C. Any examiner authorized by the department shall, so far as necessary for the purposes of the examination or review, have access during regular business hours to the premises and to any books, records, files, or property of the licensee as far as they directly relate to this regulation and Articles 1.1 (§ 32.1-137.1 et seq.) and 1.2 (§ 32.1-137.7 et seq.) of Chapter 5 of Title 32.1 of the Code of Virginia.

All material copied, recorded, or received by the department from the MCHIP licensee shall be privileged and confidential and shall not be subject to subpoena.

D. The MCHIP licensee shall be responsible for ensuring that all examination materials are submitted to the department at the time specified for submission and that they are complete. Failure to submit all of the examination materials as required may delay processing or result in the denial of the issuance or renewal of the quality assurance certificate.

E. A summary report of an MCHIP licensee's examination shall become part of the department's public file on the MCHIP. A copy of the summary report shall be provided to the Bureau of Insurance.

F. The department shall consider an MCHIP licensee's initial examination for a certificate of quality assurance as an evaluation of the MCHIP's quality assurance program in order to determine if it has the structure, organization, and policies and procedures in place to provide and support quality improvement activities.

G. Information provided during any examination conducted regarding compliance with this chapter shall be accurate and truthful. The MCHIP licensee shall not provide the department with falsified information during any aspect of the examination process. The department shall construe any effort to provide falsified information as violation of the statute, and the MCHIP licensee shall be subject to disciplinary action. Falsification is defined for the purpose of this chapter as fabrication, in whole or in part, of any information provided by the MCHIP or the MCHIP licensee.

H. The refusal of any MCHIP licensee, by its officers, directors, employees or agents, to submit to examination or review or to comply with any reasonable written request of the examiners shall be grounds for suspension, revocation, denial, or nonrenewal of a certificate of quality assurance held by the licensee.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

12VAC5-408-70 Administrative review

A. The initial examination shall be an administrative review of the application for certificate of quality assurance and supporting documentation that includes:

1. The items listed in subsections F, G, H, and I of 12VAC5-408-160, except that if the MCHIP is accredited by a nationally recognized accrediting body appropriate for the type of MCHIP and approved by the department, it shall not be required to include in its application the items listed in subdivisions F 5, G 2, G 3, G 7 and subsection I;

2. A copy of the most recent accreditation report executive summary, as applicable issued to the MCHIP or to the MCHIP's licensee from a nationally recognized accrediting body that evaluates quality assurance programs, with the written corrective action response, if any;

3. For MCHIP licensees that have been cited by another state or the District of Columbia concerning their quality assurance program, a copy of the most recent report of an examination of the quality of health care provided by the MCHIP under similar laws and regulations of another state, with a copy of the written corrective action response, if any;

4. The most recent report of any examination of the quality assurance program provided by the MCHIP issued by a federal regulatory agency with similar laws and regulations. Submission of this report shall not be necessary if the MCHIP provides a copy of the report required by subdivision 2 of this subsection with the written corrective action plan, if any; and

5. The department may coordinate with the Bureau of Insurance to obtain information that may assist its review.

B. The administrative review examination shall be conducted within 45 business days of the receipt of all the documentation required by the department. The MCHIP licensee shall be notified in writing if additional information is needed to clarify the information submitted and the specific time period in which to submit the materials. Accreditation by a nationally recognized accrediting body appropriate to the type of MCHIP and acceptable to the department shall be sufficient to demonstrate compliance with state requirements pursuant to 12VAC5-408-50. Nothing in the preceding sentences shall preclude the department from imposing further requirements if the regulatory requirements are more stringent than the nationally recognized accrediting body's standards.

C. The MCHIP licensee shall be notified of the results of the administrative review examination within 60 business days from the receipt by the department of all of the required documents and related information.

The department, at its discretion, may extend, for up to an additional 30 days, the period of time within which to approve or disapprove the information submitted. Licensees shall be notified in writing of any such extension.

D. The department, at its discretion, may conduct an onsite examination of the MCHIP licensee's quality assurance program if, for example, during its conduct of the administrative review examination, the department determines that an onsite examination is warranted in order to determine the MCHIP licensee's compliance with applicable laws or this chapter.

E. Licensees with MCHIPs that successfully complete the examination shall be issued a certificate of quality assurance. Licensees with MCHIPs that do not successfully complete the examination shall be denied a certificate of quality assurance. Licensees with more than one MCHIP requesting separate certificates for each MCHIP shall file a separate certificate of quality assurance application for any of their MCHIPs with an accompanying fee. Each of the licensee's MCHIPs that were filed with separate applications that successfully complete the examination shall be issued a certificate of quality assurance. Each of the licensee's MCHIPs that were filed with separate applications that do not successfully complete the examination shall be denied a certificate of quality assurance.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; Errata, 16:7 VA.R. 823 December 20, 1999; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

12VAC5-408-80 Renewal application

A. Every MCHIP licensee shall request renewal of its certificate of quality assurance biennially with the department. The purpose of the renewal examination shall be to determine if the MCHIP has maintained compliance with applicable laws and regulations since the last certificate of quality assurance was issued or renewed, and whether the MCHIP is using its best efforts to meet its quality assurance goals as set forth in its quality assurance plan.

B. The renewal examination shall include an administrative review of the renewal application and supporting documentation that includes:

1. The items listed in subsections F, G, H, and I of 12VAC5-408-160, except that if the MCHIP is accredited by a nationally recognized accrediting body appropriate for the type of MCHIP and acceptable to the department, it shall not be required to include in its application the items listed in subdivisions F 5, G 2, G 3, G 7 and subsection I;

2. The annual complaint reports;

3. The MCHIP's formal written evaluations of its quality assurance program expectations for the time period since the MCHIP's last application for a certificate of quality assurance;

4. A copy of the most recent accreditation report executive summary, as applicable, issued to the MCHIP or to the licensee from a nationally recognized accrediting body that evaluates quality assurance programs if the report was issued after the issuance of the current certificate from the department, provided that resubmission of the most recent accreditation report previously submitted in the prior initial or renewal application shall not be required, unless there has been a completed accreditation survey since that time that has led to renewal, suspension, or denial of accreditation and the written corrective action plan in response to the report, if applicable, shall also be submitted;

5. For MCHIP licensees that have been cited by another state or the District of Columbia concerning the quality of health care provided or administered, a copy of the most recent report of an examination of the quality of health care provided by the MCHIP under similar laws and regulations of another state or the District of Columbia, and a copy of the written corrective action response; and

6. A copy of the report of any examination of the MCHIP by a federal regulatory body with similar laws and regulations issued since the certificate of quality assurance was last issued or renewed, provided that submission of this report shall not be necessary if the MCHIP licensee submits a copy of the report required by subdivision 4 of this subsection.

C. In addition, the department shall consider the following in its renewal examination:

1. The report of any comprehensive onsite examination of the MCHIP or licensee if one was conducted during the renewal period; and

2. Any disciplinary actions or sanctions issued by the department pursuant to § 32.1-137.5 of the Code of Virginia or this chapter, or by the Bureau of Insurance in keeping with § 32.1-137.2 E of the Code of Virginia.

D. The department may consider a summary report of the analysis of any data required to be reported by state law or regulation to the Health Care Data Reporting System in its renewal examination.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

12VAC5-408-90 Comprehensive onsite examination

A. The comprehensive onsite examination represents a periodic quality assurance evaluation process designed to ensure that the MCHIP licensee has in place the appropriate systems and processes to meet the requirements set forth in this chapter.

B. A comprehensive onsite examination shall be conducted triennially except for MCHIPs that meet the criteria specified in 12VAC5-408-100 pertaining to nationally recognized accreditation.

C. The comprehensive onsite examination shall take place:

1. At a time established by the department with 90 days advance notification to the MCHIP licensee;

2. In conjunction with a Bureau of Insurance market conduct examination of the licensee; or

3. At the request of the MCHIP licensee in agreement with the department following the completion of an initial administrative review examination for certification in order to document any corrective action taken in response to the initial examination.

At the department's discretion and in response to complaints against the MCHIP licensee or the MCHIP, the department may expand a complaint investigation to a comprehensive examination to determine compliance with the MCHIP laws and regulations if it appears that covered person's health and safety may be jeopardized.

D. The MCHIP licensee shall be notified in writing at least 90 days in advance of the comprehensive onsite examination and shall be provided with information regarding the parameters of the examination.

The final determination of when a comprehensive onsite examination shall be conducted rests with the department. However, the department will take into consideration mitigating circumstances presented by the MCHIP licensee.

E. The MCHIP licensee or the department may request a preexamination conference for the purpose of discussing preparations for the examination. The conference shall not be used for determining whether a plan needs to be examined or the frequency of an onsite comprehensive examination.

F. Prior to the comprehensive onsite examination, the MCHIP licensee shall make available to the department the results of a member satisfaction survey or other initiative conducted to obtain member input regarding the MCHIP licensee. If the MCHIP licensee did not conduct a member satisfaction survey or initiative, then the MCHIP licensee will publish public notice soliciting comments from the MCHIP's covered persons regarding satisfaction with the MCHIP.

G. The MCHIP shall be notified of the results of the comprehensive onsite examination within 60 business days of the final day of the examination. The department may choose to notify the MCHIP earlier than 60 days and require immediate corrective action or initiate administrative disciplinary hearings for findings of serious or substantial noncompliance with the law or the regulations that could jeopardize covered persons' health or safety.

H. Depending on the examination findings, the department shall:

1. Require a corrective action plan as specified in 12VAC5-408-110 with a time frame in which corrective action shall be completed and verified by the department;

2. Proceed with disciplinary action or sanctions as specified in 12VAC5-408-140; or

3. Notify the MCHIP licensee that it is fully and completely in compliance with all applicable regulations.

I. If the MCHIP licensee applicant has achieved accreditation from a nationally recognized accreditation entity acceptable to the department, it will be exempt from the comprehensive on-site examination following receipt of all accreditation findings.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

12VAC5-408-100 Examination by a nationally recognized accreditation organization

A. The department shall accept the accreditation of an MCHIP licensee or MCHIP by a nationally recognized accrediting body appropriate to the type of MCHIP and approved by the department in lieu of the triennial comprehensive onsite examination described in 12VAC5-408-90 under the following conditions:

1. Conditional or provisional accreditation may be considered acceptable for meeting the requirements of this chapter provided that a second examination by a nationally recognized accrediting body is scheduled and completed within 15 to 18 months of the date a decision for conditional or provisional accreditation is made by the accrediting body, and that the second examination leads to an accreditation status that is not conditional or provisional.

2. The MCHIP licensee shall release to the department a copy of a report or document from a nationally recognized accrediting body containing that body's final report, or evaluation of the MCHIP's compliance with accreditation standards. The department may, at its discretion and on a case-by-case basis, request from the licensee any and all reports, letters and memoranda issued by the nationally recognized accrediting body to the licensee regarding the licensee's accreditation application or its evaluation for accreditation. In the event a licensee is granted only conditional or provisional accreditation, any written materials generated by the licensee regarding corrective or remedial action to be taken for achieving compliance with the accreditation standards shall also be released to the department at the same time the nationally recognized accrediting body is notified. The MCHIP licensee shall forward copies of the executive summary of its accreditation report to the department within 10 days of receipt by the MCHIP licensee, unless otherwise directed by the department.

3. The MCHIP licensee notifies the department of the date of its accreditation examination.

The department reserves the right to conduct a comprehensive examination of an accredited MCHIP when it appears that the health and safety of the covered persons may be jeopardized.

B. Accreditation by a nationally recognized accrediting body will not be accepted in lieu of the comprehensive onsite examination unless the accreditation standards are appropriate for the type of plan seeking exemption from the department's comprehensive onsite examination.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

12VAC5-408-110 Corrective action procedures

A. Within 30 business days of the conclusion of the examination, the department shall provide the MCHIP licensee with a written summary of violations of the regulations or laws and any factual findings used as a basis to determine that a violation has occurred.

B. The department shall require the MCHIP licensee to submit a written plan of correction specifying how each violation will be corrected along with the time frames for completion of each corrective action. A single plan of correction shall address all events associated with a given violation. The plan of correction, when required, shall be submitted by the MCHIP licensee within 20 business days of receipt of the notice of violation, or sooner, if the department determines that the violations jeopardize the safety of covered persons.

C. The plan of correction shall be approved when the MCHIP licensee demonstrates to the satisfaction of the department that compliance will be achieved. If the plan of correction is not approved, the department may request that an amended plan of correction be submitted within 10 business days, or sooner, if the department determines that the violations jeopardize the safety of covered persons.

D. The summary of violations and the plan of correction shall not be released as public information until the department has approved the plan of correction or, in the event no plan of correction is required, after 20 business days of receipt of the summary of violations by the MCHIP licensee, whichever is sooner.

E. Unless otherwise documented, the department will presume receipt of the summary of violations by the MCHIP licensee by the seventh business day when mailed return receipt requested.

F. Failure of the MCHIP licensee to successfully implement the written plan of correction within a specified time period may result in an administrative sanction.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

12VAC5-408-120 Changes to geographic service areas

A. No MCHIP shall operate in a manner that varies in a material manner with the geographic service area information submitted pursuant to this chapter. Any changes in such information which would result in operational changes that vary in a material manner with the information currently on file with the department shall be subject to the department's prior approval.

B. The request for a material change in a geographic service area shall include:

1. A description of the current geographic service area including a map of the current service area, a list of current primary care and specialty physicians and other providers, and the number of covered persons by service area.

2. An explanation as to whether the MCHIP is requesting an expansion or a reduction in its service area.

3. Notification that the MCHIP licensee has inquired of the Bureau of Insurance as to whether or not the service area request constitutes a material change and the bureau's determination, if available.

4. If a service area expansion is proposed, then the following is required:

a. A description of the service area that includes a map of the geographic service area expansion, projections of new enrollment, a listing of new primary care and specialty providers and other providers and their locations, and physician capacity to accept the anticipated enrollment;

b. Information necessary to determine if the MCHIP licensee will be capable of conforming to the access, availability, and travel requirements of 12VAC5-408-260 and 12VAC5-408-270; and

c. The methodology used to determine that the current health care system in the proposed service area can support the expansion.

5. If an MCHIP is reducing or eliminating a service area, the following information is required:

a. A description of the service area being reduced or eliminated;

b. The reason for the reduction or elimination of the service area and the effective date on which health care services will no longer be available through the MCHIP; and

c. Any information required by the department to determine that MCHIP covered persons are ensured continuity of care during the transition.

C. If the department fails to act on a notice of material change within 30 days of receipt of filing all necessary information, the proposed changes shall be deemed approved. The department, at its discretion, may extend the period of time within which to approve or disapprove the proposed changes for up to an additional 30 days. Licensees shall be notified in writing of any such extensions.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

12VAC5-408-130 Complaint system, complaint examination and investigation

A. Each MCHIP licensee shall establish and maintain for each of its MCHIPs a complaint system approved by the department and the Bureau of Insurance to provide reasonable procedures for the resolution of complaints.

B. The department, on behalf of the commissioner and in cooperation with the Bureau of Insurance, shall examine the complaint system for compliance of the system with applicable statutes and regulations and shall require corrections or modifications as necessary. The effectiveness of the complaint system in allowing covered persons, or their duly authorized representatives, to have issues regarding quality assurance appropriately resolved shall be assessed by the department.

C. The department has the responsibility to investigate complaints regarding quality of care violations filed by or on behalf of covered persons.

D. Every person from whom information is sought in an investigation of a complaint against an MCHIP licensee shall cooperate in producing, or allowing reasonable access during regular business hours to, the books, records, files, accounts, papers, documents, and any or all computer or other recordings of the licensee being examined or those of any person or delegated services entity delivering health care services under contract, affiliation, delegation or other arrangement. Information shall be limited to that which is relevant to the investigation in question.

E. Deficiencies found during a complaint investigation shall be corrected as required in 12VAC5-408-110.

F. When the investigation is complete, the MCHIP licensee and the complainant will be notified of the findings of the investigation.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

12VAC5-408-140 Administrative sanctions

A. Nothing in this part shall prohibit the department from exercising its responsibility and authority to enforce applicable law and this chapter including proceeding directly to imposition of administrative sanctions.

B. The department, in consultation with the Bureau of Insurance, may impose such administrative sanctions or take such actions as are appropriate for violation of any of the regulations or laws. Such sanctions include:

1. Imposing civil monetary penalties, which shall not exceed $1,000 per incident of noncompliance, to a maximum of $10,000 for a series of related incidents of noncompliance;

2. Placing a certificate holder on probation;

3. Temporarily suspending a certificate of quality assurance;

4. Temporarily restricting or prohibiting, with the concurrence of the Bureau of Insurance, new enrollments into an MCHIP;

5. Revoking or not renewing a certificate of quality assurance and certifying to the Bureau of Insurance that an MCHIP licensee or its managed care health insurance plan is unable to fulfill its obligations to furnish quality health care services; or

6. Other remedies as provided by state or federal law.

C. The MCHIP licensee shall receive a written notice describing the reasons for the imposition of sanctions and a report specifying the findings of noncompliance. Upon receipt of the notice to impose a sanction, the MCHIP licensee shall have the right and the opportunity to appeal the sanction according to § 32.1-137.5 of the Code of Virginia. A copy of the department's notice shall be provided to the Bureau of Insurance.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

12VAC5-408-150 Surrender of certificate

A. Upon revocation or suspension of a certificate or loss of license, the MCHIP licensee must surrender its certificate to a representative of the center.

B. In the event an MCHIP licensee voluntarily ceases operation, it shall provide at least 90 business days advance written notice to all covered persons, employers, providers, the department, and the Bureau of Insurance. The notice shall identify the storage location of business and medical records, where applicable, and procedures for obtaining copies of such records.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

Part II Administrative Services

12VAC5-408-160 Management and administration

A. No person shall establish or operate a managed care health insurance plan in Virginia without first obtaining a license from the Bureau of Insurance and a certificate of quality assurance from the department.

B. The MCHIP licensee must comply with:

1. This chapter;

2. Other applicable federal, state or local laws and regulations; and

3. The MCHIP licensee's own policies and procedures.

C. The MCHIP licensee shall submit or make available reports and information as described in § 32.1-137.4 of the Code of Virginia necessary to establish compliance with these standards and applicable laws.

D. The MCHIP licensee shall permit representatives from the center to conduct examinations or reviews to:

1. Verify application information;

2. Determine compliance with these standards;

3. Review necessary records, including contracts for delegated services and capitated rate information; and

4. Investigate complaints and review appeals procedures.

E. The licensee shall notify the center and providers in writing within 30 days of implementing any material changes affecting the MCHIP licensee, including:

1. Mailing address;

2. Ownership;

3. Health care services provided, including any delegated services;

4. Medical director;

5. MCHIP or licensee name;

6. Significant provider network changes; and

7. Any material changes in the quality assurance program, complaint process, or utilization review process.

If more advanced notice of a specific change is required by law for notices to providers or covered persons, notice given to the department under this section shall be no less than notice given to covered persons under the law.

F. All applications, including those for renewal, shall require:

1. A description of the geographic area to be served with a map clearly delineating the boundaries of the service area or areas;

2. A description of the complaint system required under § 32.1-137.6 of the Code of Virginia and 12VAC5-408-130;

3. A description of the procedures and programs established by the licensee to assure both availability and accessibility of adequate personnel and facilities;

4. A list of the MCHIP licensee's managed care health insurance plans; and

5. A description of the MCHIP's quality assurance program.

G. In addition, applications shall include the following:

1. A detailed description of the MCHIP's prescription drug benefit program, if one is offered;

2. If the MCHIP requires or performs utilization management, the utilization review plan including a description of the criteria, clinical and therapeutic guidelines, and their derivation or source;

3. A description of the MCHIP licensee's credentialing process;

4. The current provider directory, so that the department can determine whether it complies with subsection G of § 38.2-3407.10 of the Code of Virginia;

5. A copy of the MCHIP's evidence of coverage or insurance plan coverage limitations and exclusions and other information provided to covered persons;

6. A description of all types of payment arrangements that the MCHIP licensee uses to compensate providers for health care services rendered to covered persons, including, but not limited to, withholds, bonus payments, capitation, processing fees, and fee-for-service discounts; and

7. For those MCHIP licensees that conduct clinical studies, a list of clinical studies with abstracts of study design, objectives and, if available, results as applicable to the type of MCHIP licensee.

H. A list demonstrating the health care services, as required by law, that the licensee provides, arranges, pays for, or reimburses shall be appropriately integrated throughout the MCHIP's service area. Services shall be based upon prevailing nationally recognized standards of medical practice.

I. The licensee shall have a written policy stating the MCHIP licensee treats covered persons in a manner that respects their rights as well as its expectations of provider and covered person responsibilities. The services shall be accessible to all covered persons, including those with diverse cultural and ethnic backgrounds, and those with physical and mental disabilities.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

12VAC5-408-170 Provider credentialing and recredentialing

A. The MCHIP licensee shall establish and maintain a comprehensive credentialing verification program to ensure its providers meet the minimum standards of professional licensure or certification. Written supporting documentation for providers who have completed their residency or fellowship requirements for their specialty area more than 12 months prior to the credentialing decision shall include:

1. Current valid license and history of licensure or certification;

2. Status of hospital privileges, if applicable;

3. Valid DEA certificate, if applicable;

4. Information from the National Practitioner Data Bank, as available;

5. Education and training, including post graduate training, if applicable;

6. Specialty board certification status, if applicable;

7. Practice or work history covering at least the past five years; and

8. Current, adequate malpractice insurance and malpractice history of at least the past five years.

B. The MCHIP licensee may grant provisional credentialing for providers who have completed their residency or fellowship requirements for their specialty area within 12 months prior to the credentialing decision. Written supporting documentation necessary to provisionally credential a practitioner shall include:

1. Primary source verification of a current, valid license to practice prior to granting the provisional status;

2. Written confirmation of the past five years of malpractice claims or settlements, or both, from the malpractice carrier or the results of the National Practitioner Data Bank query prior to granting provisional status; and

3. A completed application and signed attestation.

C. Providers provisionally credentialed may remain so for 60 calendar days.

D. Policies for credentialing and recredentialing shall include:

1. Criteria used to credential and recredential;

2. Process used to make credentialing and recredentialing decisions;

3. Type of providers, including network providers, covered under the credentialing and recredentialing policies;

4. Process for notifying providers of information obtained that varies substantially from the information provided by the provider;

5. Process for receiving input from participating providers to make recommendations regarding the credentialing and recredentialing process; and

6. A requirement that the MCHIP licensee notify the applicant within 60 calendar days of receipt of an application if information is missing or if there are other deficiencies in the application. The MCHIP licensee shall complete the credentialing process within 90 calendar days of the receipt of all such information requested by the MCHIP licensee or, if information is not requested from the applicant, within 120 calendar days of receipt of an application. If there is a contractual relationship between the MCHIP licensee and the applicant or entity for whom the applicant is employed or engaged, the timeframes for notification that the application is not complete and completion of the credentialing process shall be in accordance with the protocols and procedures established by the MCHIP licensee under subsection O of this section. The department may impose administrative sanctions upon an MCHIP licensee for failure to complete the credentialing process as provided in this section if the department finds that such failure occurs with such frequency as to constitute a general business practice.

The policies shall be made available to participating providers and applicants upon written request.

E. A provider fully credentialed by an MCHIP licensee, who changes his place of employment or his nonMCHIP licensee employer, shall, if within 60 calendar days of such change and if practicing within the same specialty, continue to be credentialed by that MCHIP licensee upon receipt by the MCHIP licensee of the following:

1. The effective date of the change;

2. The new tax ID number and copy of W-9, as applicable;

3. The name of the new practice, contact person, address, and telephone and fax numbers; and

4. Other such information as may materially differ from the most recently completed credentialing application submitted by the provider to the MCHIP licensee.

This provision shall not apply if the provider's prior place of employment or employer had been delegated credentialing responsibility by the MCHIP licensee.

Nothing in this section shall be construed to require an MCHIP licensee to contract or recontract with a provider.

F. The providers shall be recredentialed at least every three years. Recredentialing documentation shall include:

1. Current valid license or certification;

2. Status of hospital privileges, if applicable;

3. Current valid DEA registration, if applicable;

4. Specialty board eligibility or certification status, if applicable;

5. Data from covered person complaints and the results of quality reviews, utilization management reviews, and covered persons satisfaction surveys, as applicable; and

6. Current, adequate malpractice insurance and history of malpractice claims and professional liability claims resulting in settlements or judgments.

G. All information obtained in the credentialing process shall be subject to review and correction of any erroneous information by the health care provider whose credentials are being reviewed. Nothing in the previous sentence shall require an MCHIP or MCHIP licensee to disclose to a provider, or any other person or party, information or documents (i) that the MCHIP or the MCHIP licensee, itself, develops or causes to be developed as part of the MCHIP's credentialing process or (ii) that are privileged under applicable law. The department may require the MCHIP licensee to provide a copy of its credentialing policies.

H. Providers shall be required by the MCHIP licensee to notify the MCHIP of any changes in the status of any credentialing criteria.

I. The MCHIP licensee shall not refuse to initially credential or refuse to reverify the credentials of a health care provider solely because the provider treats a substantial number of patients who require expensive or uncompensated care.

J. The MCHIP licensee shall have policies and procedures for altering the conditions of the provider's participation with the MCHIP licensee. The policies shall include actions to be taken to improve performance prior to termination and an appeals process for instances when the MCHIP licensee chooses to alter the condition of provider participation based on issues of quality of care or service, except in circumstances where a covered person's health has been jeopardized. Providers shall have complete and timely access to all data and information used by the licensee to identify or determine the need for altering the conditions of participation.

K. The MCHIP licensee shall retain the right to approve new providers and sites based on quality issues and to terminate or suspend individual providers. Termination or suspension of individual providers for quality of care considerations shall be supported by documented records of noncompliance with specific MCHIP expectations and requirements for providers. The provider shall have a prescribed system of appeal of this decision available to the provider as prescribed in the contract between the MCHIP or its delegated service entity and the provider.

L. Providers shall be informed of the appeals process. Profession specific providers actively participating in the MCHIP plan shall be included in reviewing appeals and making recommendations for action.

M. The MCHIP licensee shall notify appropriate authorities when a provider's application or contract is suspended or terminated because of quality deficiencies by the health care provider whose credentials are being reviewed.

N. There shall be an organized system to manage and protect the confidentiality of personnel files and records. Records and documents relating to a provider's credentialing application shall be retained for at least seven years.

O. The MCHIP licensee shall establish protocols and procedures for processing new provider credentialing applications and reimbursing new provider applicants, after being credentialed by the MCHIP licensee, for health care services provided to covered persons during the period in which the approved applicant's completed credentialing application was pending. At a minimum, the protocols and procedures shall require the following:

1. If the MCHIP licensee accepts applications through an online credentialing system, the MCHIP licensee shall notify a new provider applicant through the online credentialing system that the provider has submitted and attested to the application as notice by the carrier that the application is received. If the MCHIP licensee does not accept applications through an online credentialing system, the MCHIP licensee shall within 10 days of receiving an application provide notification to the new provider applicant either by postal mail or electronic mail, as selected by the applicant, that the application was received;

2. Beginning January 1, 2024, a new provider applicant's application is deemed complete within 30 days of the MCHIP licensee receiving the application, unless the MCHIP licensee has provided notice that the application is not complete. Notice shall be provided by electronic mail unless the provider applicant has selected notification by postal mail;

3. The MCHIP licensee shall approve or deny a new provider applicant credentialing application within 60 days of receiving a completed application;

4. Claims submitted according to the MCHIP licensee's claims submittal policies for services rendered during the period of a pending application shall be adjudicated and paid no later than 40 days after the new provider applicant is credentialed and contracted;

5. The protocols and procedures shall apply only if a contractual relationship exists between the MCHIP licensee and the new provider applicant or entity for whom the new provider applicant is employed or engaged; and

6. Any reimbursement shall be paid at the in-network rate that the new provider applicant would have received had the provider been, at the time the covered health care services were provided, a credentialed participating provider in the network for the applicable managed care plan.

P. Nothing in this section shall require:

1. Reimbursement of provider-rendered services that are not benefits or services covered by the MCHIP licensee's managed care plan.

2. An MCHIP licensee to pay reimbursement at the contracted in-network rate for any covered health care services provided by the new provider applicant if the new provider applicant's credentialing application is not approved or the MCHIP licensee is otherwise not willing to contract with the new provider applicant.

Q. Payments made or retroactive denials of payments made under this section shall be governed by § 38.2-3407.15 of the Code of Virginia.

R. If a payment is made by the MCHIP licensee to a new provider applicant or any entity that employs or engages a new provider applicant under this section for a covered service, the patient shall only be responsible for any coinsurance, copayments, or deductibles permitted under the insurance contract with the MCHIP licensee or participating provider agreement with the provider.

S. A new provider applicant, in order to submit claims to the MCHIP licensee pursuant to this section, shall provide written or electronic notice to covered persons in advance of treatment that:

1. The provider has submitted a credentialing application to the MCHIP licensee of the covered person; and

2. The MCHIP licensee is in the process of obtaining and verifying the written documentation from the new provider applicant pursuant to subsection A of this section.

The written or electronic notice shall conform to the requirements in § 38.2-3407.10:1 G of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-137.3 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002; Volume 37, Issue 14, eff. April 15, 2021; Volume 40, Issue 5, eff. November 22, 2023.

12VAC5-408-180 Complaint system

A. Every MCHIP licensee shall establish and maintain a system for the resolution of complaints brought by covered persons, or by providers acting on behalf of an covered person and with the covered person's consent, including complaints regarding availability, delivery, or quality of health care services, or any other matter pertaining to the covered person's contractual relationship or status as a third party beneficiary with the MCHIP.

The system shall include:

1. Written notification to all covered persons of the procedures, including telephone numbers and addresses, for contacting the MCHIP with a complaint and telephone numbers and addresses of the complaint unit of the center and the Office of the Managed Care Ombudsman to help with complaints or appeals;

2. A description of the process used to investigate and resolve complaints, including specific time lines for each step in the complaint process; and

3. A description of the process used to document and track the status of all complaints and compile the complaint information required to be reported to the department under § 32.1-137.6 C of the Code of Virginia.

B. Time lines for responding to complaints shall accommodate clinical urgency and shall not exceed 30 days from receipt of the complaint. Resolution of complaints shall not exceed 60 days from date of receipt of the complaint.

C. The MCHIP licensee shall keep records of complaints filed including:

1. Complaint identifier, using a unique identification code assigned consistently to the covered person;

2. Date complaint received;

3. A general description of the reason for the complaint;

4. Date of each review and hearing, if any;

5. The number of days to gather the information necessary to resolve the complaint;

6. Date closed;

7. Resolution of the complaint;

8. Record of internal actions necessary as a result of the complaint resolution, as applicable; and

9. Notification to the covered person of the resolution.

D. No covered person who exercises the right to file a complaint or an appeal shall be subject to disenrollment or otherwise penalized due to the filing of a complaint or appeal.

E. Complaint records shall be maintained from the date of the MCHIP licensee's last examination and for no less than five years.

F. A description of the systems for filing complaints and appeals shall be provided to covered persons at the time of enrollment and upon request thereafter.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

12VAC5-408-190 Covered person education and communication

A. The MCHIP licensee shall make available to each covered person at the time of enrollment or at the time the contract or evidence of coverage is issued, as required by law and upon request thereafter, policies and procedures applicable to the covered person including, but not limited to:

1. A statement of covered person's rights and responsibilities;

2. Procedures for obtaining care including:

a. Referral and authorization requirements;

b. Primary care services;

c. Specialty care and hospital services;

d. Behavioral services, when the complexity of the covered person's condition requires the knowledge base and expertise beyond those of the primary care provider;

e. Emergency services and after-hours coverage, including access to emergency care, and any requirements for prior authorization and payment for out-of-service areas;

f. Care and coverage when out of the service area;

g. Out-of-network services; and

h. Pharmacy services;

3. Procedures concerning the complaint process and the process for appealing adverse decisions affecting covered person coverage benefits;

4. To the extent there are coverage restrictions for changing primary care providers, procedures for changing primary care and specialty care providers including any restrictions on changing providers;

5. All necessary mailing addresses and telephone numbers for seeking information or authorization;

6. The toll-free number for the complaint unit of the center; and

7. Notice of the right to obtain information on types of provider payment arrangements used to compensate providers for health care services rendered to covered persons, including, but not limited to, withholds, bonus payments, capitation, processing fees, and fee-for-service discounts.

B. Lists of all network providers shall be made available to covered persons as required in subsection G of § 38.2-3407.10 of the Code of Virginia.

C. There shall be a mechanism for providing covered person information in plain language that is clearly understood and in the languages of the major population groups served.

D. Covered persons shall be provided an opportunity for input regarding the service provided by the MCHIP and any mechanism for input shall be disclosed to them.

E. There shall be a mechanism for assisting covered persons affected by changes in the MCHIP licensee's service areas or network providers. Such mechanisms may include access to information through an internet website, a toll-free telephone number, an electronic copy of the MCHIP's current provider directory, newsletters or any combination thereof.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

12VAC5-408-200 Data management

A. The data management system shall be reasonable and adequate to assess, measure and evaluate the functions of the quality assurance program.

B. If the MCHIP licensee has healthcare data and information, the data management system, which includes medical records, shall comply with federal and state law and regulations, including the Virginia Health Records Privacy Act (§ 32.1-127.1:03 of the Code of Virginia).

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

12VAC5-408-210 Medical records

A. The MCHIP licensee shall require that an organized medical record system be maintained by providers that assures the availability of information required for effective and continuous covered person care and for quality received.

B. Medical records shall be confidential. Only authorized personnel shall have access as specified in § 32.1-127.1:03 of the Code of Virginia. Written procedures shall govern the use and removal of medical records and the conditions for release of information. The covered person's written consent shall be required for release of information as required by law.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

Part III Quality Improvement Program

12VAC5-408-220 Purpose

The MCHIP licensee shall have a comprehensive, systematic, and organized quality assurance program for the purpose of:

1. Improving covered person's health outcomes;

2. Assuring the quality of the services provided to covered persons;

3. Increasing covered person satisfaction;

4. Maximizing opportunities for MCHIP improvements and minimizing opportunities for errors;

5. Monitoring, measuring and evaluating quality activities; and

6. Satisfying all federal and state reporting requirements.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

12VAC5-408-230 Program requirements

A. The MCHIP licensee shall be structured operationally to administer the quality assurance program. The quality assurance operations shall include, but not be limited to:

1. Establishing performance goals designed to improve the quality of health care services provided by the MCHIP licensee and governed by the certificate;

2. Developing a quality assurance plan to implement the goals;

3. Measuring and assessing the MCHIP licensee's performance in meeting the goals;

4. Implementing activities based upon the assessments to improve and maintain performance;

5. Integrating the quality assurance activities of appropriate organizational units, providers, delegated service providers, and the governing body into the quality assurance program and providing feedback to those entities;

6. Enlisting covered person input through sources such as satisfaction surveys, reviews of complaints, appeals, and requests to change providers;

7. Maintaining and documenting the licensee's compliance with state and federal laws, as well as private accreditation requirements, if applicable, that govern the MCHIP licensee's quality assurance program; and

8. Ensuring that the MCHIP licensee's quality assurance goals are communicated to all appropriate organizational units of the MCHIP licensee and delegated health service entities and made available to covered persons and providers upon request.

B. The quality assurance program shall be managed by professional personnel qualified by training and experience to implement the MCHIP licensee's program goals. The organizational relationship and responsibilities for quality assurance shall be clearly defined.

C. The quality assurance program shall be structured to include:

1. Operations accountable for the quality assurance program;

2. A quality assurance program advisory committee whose members include covered persons and representatives from the operations responsible for quality assurance, utilization management, provider affairs, credentialing, complaints and appeals, customer service, medical records, and data management; and

3. A designated physician or clinical professional appropriate to the type of the MCHIP licensee.

D. The MCHIP licensee shall designate a board-certified physician or clinical professional appropriate to the type of MCHIP to serve as the designated physician or clinical professional.

E. The designated physician, or clinical professional as appropriate to the type of MCHIP licensee, must have substantial involvement in the quality assurance program. Substantial involvement may be evidenced by:

1. Defining the responsibilities and interrelationships for professional services;

2. Coordinating, supervising and overseeing the functioning of professional services;

3. Providing input into the medical performance of providers;

4. Overseeing the continuing in-service education of the MCHIP's professional staff;

5. Providing clinical direction and leadership to the continuous quality assurance program;

6. Establishing policies and procedures covering all health care services provided to covered persons; and

7. Ensuring review of provider credentials including, but not limited to:

a. Delineating qualifications for participating in the MCHIP;

b. Establishing a system for verification of providers' credentials, recredentialing, performance reviews; and

c. Obtaining information about any disciplinary action against a provider.

F. The quality assurance program advisory committee shall:

1. Recommend policies for quality assurance;

2. Review and approve the quality assurance program;

3. Evaluate the results of the quality assurance program;

4. Initiate quality assurance activities; and

5. Ensure implementation of the quality assurance program.

G. All determinations and actions made by the committee shall be recorded in minutes that are dated, approved and current.

H. The quality assurance program operations shall maintain written descriptions of the responsibilities of each of the operational units of the licensee and the governing body in the planning, development, implementation and evaluation of the MCHIP licensee's quality assurance program. The descriptions shall include an organizational chart.

I. A written report shall be issued annually by quality assurance operations to the MCHIP licensee's executive management and to the governing body. The purpose of the report shall be to evaluate the MCHIP licensee's quality assurance program activities including, at a minimum:

1. The MCHIP licensee's achievements in meeting its quality assurance expectations;

2. Those areas where expectations were not met or where improvements are still needed;

3. The impact of the MCHIP licensee's quality assurance program, including specific programmatic initiatives, on the quality of care received by covered persons as assessed using reasonable indicators; and

4. New areas identified through the quality assurance assessment process that will be incorporated in the next annual quality assurance program plan.

J. The quality assurance program is accountable to the governing body. Documentation shall be maintained by the MCHIP licensee that the governing body has reviewed the annual quality assurance program report and has provided direction to the program and, as necessary, other operational units in response to the report.

K. A summary of the program shall be provided to appropriate managers, providers and staff members of the MCHIP licensee, and shall be available to covered persons of the MCHIP upon request.

L. There shall be a mechanism in place to inform covered persons, providers, and employers of the MCHIP licensee's annual performance results each year, upon request.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; Errata, 16:7 VA.R. 831 December 20, 1999; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

12VAC5-408-240 Quality assurance plan

Each MCHIP licensee shall have a written quality assurance plan. The plan shall include:

1. The quality assurance performance expectations for the MCHIP licensee for the year and an explanation as to the rationale for targeting these expectations;

2. Delineation of the expected outcomes for the performance expectations;

3. The performance activities to implement the plan and the specific lines of authority and accountability for implementation;

4. The data collection and analysis methodologies to be used to evaluate the quality of services;

5. For MCHIP licensees that have access to clinical data, clinical studies, applicable to the type of MCHIP, that target clinical diagnosis and treatments with the requirement that those diagnoses focused upon are pertinent to a substantial number of its covered persons, or have been identified as major public health risks. The plan shall also include studies that are pertinent to the covered persons of the product lines that the MCHIP manages or that address major public health risks;

6. Strategies to evaluate provider performance and systems, request corrective action when patterns are identified, and act when corrective action has not been taken;

7. Methods to assess covered person satisfaction so as to identify opportunities for improvement and set improvement goals;

8. For MCHIP licensees that have access to clinical data, evaluations of the actual outcomes of care provided to selected groups of covered persons with an analysis of variations in care;

9. For MCHIP licensees that have access to clinical data, amendment of treatment protocols and clinical practice guidelines, as necessary, to make them current and the development of new protocols and clinical practice guidelines, as necessary, to address clinical conditions;

10. Strategies to evaluate the continuity of care that covered persons receive; and

11. Analysis of the accessibility of covered person services including emergency services and after-hour care within the licensee's geographic service area. Compliance may be demonstrated by evidence of contract language with providers stipulating after-hour care, customer satisfaction surveys, and complaint reviews.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

Part IV Coordination and Continuity of Care

12VAC5-408-250 Continuity of care

A. The MCHIP licensee shall provide, arrange, pay for, or reimburse the basic health care services it provides in such a way that:

1. Covered persons' individual needs are assessed on an ongoing basis through their physician or staff and matched with the appropriate level of medical, psychological, or medical social services care. The MCHIP licensee shall monitor the continuity and coordination of care a covered person receives with other facets of care;

2. Covered persons' transition through the system of care are facilitated by the MCHIP licensee and its components;

3. The MCHIP licensee does not impede covered persons' involvement in determining care and treatment;

4. Information necessary to support the provision of care from one plan component to another is provided in a timely manner to covered persons and providers to support the continuity of the covered person's care; and

5. The MCHIP licensee advises its physicians of their responsibility to share specific information with covered persons concerning their illness, condition or treatment, in order for the covered person to follow his plan of care and receive follow-up care when needed.

B. The MCHIP licensee shall assist with denial of care issues by providing adequate information for covered person and provider decisions regarding ongoing care, or if appropriate, discharge.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

12VAC5-408-260 Network adequacy

A. The MCHIP licensee shall provide a sufficient number and mix of services, specialists, and practice sites to meet covered persons' health care needs, including providers serving high risk populations or those specializing in the treatment of costly conditions, and its contractual obligations with reasonable promptness.

B. The MCHIP licensee shall ensure covered persons telephone access 24 hours a day, 7 days a week, to responsible and knowledgeable health care practitioners capable of assessing the covered persons' conditions and, as necessary, providing for appropriate services.

C. The MCHIP licensee shall incorporate strategies into its access procedures to facilitate utilization of the licensee's health care services by covered persons with physical, mental, language or cultural barriers.

D. If the MCHIP licensee does not have a health care provider within its network capable of providing care to covered persons, the licensee shall cover such care out of network. The covered person shall not be responsible for any additional costs incurred by the MCHIP as a result of this referral, consistent with the evidence of coverage, other than any applicable copayment, coinsurance or deductible.

E. The MCHIP licensee shall make provisions for affected covered persons to be notified about the termination of a provider as soon as it becomes aware of the termination. The MCHIP shall inform the affected covered persons of other participating providers available to assume their care and facilitate the covered persons' transition from a terminating provider to another provider so that the covered person's continuity of care is not interrupted. Covered persons undergoing an active course of treatment shall have continued access to care during the transition period.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

12VAC5-408-270 Travel and appointment waiting times

A. An MCHIP shall set reasonable and adequate standards for the number and geographic distribution of primary care, specialty care, and institutional service sites. Such standards shall address acceptable average travel times or distances to the nearest primary care delivery site, nearest specialty care site, or nearest institutional service site for covered persons in the service area. The standards must be realistic for the community served, the delivery system utilized by the MCHIP, and clinical safety.

Institutional service sites include acute care hospitals, surgical facilities including tertiary care or other specialty hospitals, licensed acute care hospitals and outpatient surgical hospitals, psychiatric inpatient facilities and other sites as determined appropriate by the department.

B. An MCHIP licensee must set reasonable and adequate standards for access to medical care, including quantifiable and measurable standards for preventive care appointments, routine primary care appointments, urgent care, emergency care, and after-hours care. The standards must be realistic for the community served, the delivery system utilized by the MCHIP, and clinical safety.

C. An MCHIP shall, at least annually, collect and analyze data to measure its performance against the standards developed under subsections A and B of this section. The analysis shall be used by the MCHIP to identify opportunities for improvement and undertake interventions to improve performance. An MCHIP shall subsequently measure the effectiveness of such interventions in improving performance against standards.

D. Routine appointments for nonemergency or nonurgent care shall be available within two weeks of the covered person's request. The department may waive this requirement if the MCHIP licensee can successfully demonstrate that the two-week availability requirement is not feasible.

E. Preventive care appointments, including routine physical examinations, shall be available with 60 days of the covered person's request. The department may waive this requirement if the MCHIP licensee can successfully demonstrate that the 60-day availability requirement is not feasible.

F. Consultations for specialty services shall be at least as required in § 38.2-3407.11:1 of the Code of Virginia.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

12VAC5-408-280 Urgent care and emergency services

A. The MCHIP licensee shall require that participating providers allow its covered persons, on a 24-hour basis, (i) access to medical care or (ii) access by telephone to a physician or licensed health care professional with appropriate medical training who can refer or direct a covered person for prompt medical care in cases where there is a need for urgent care or emergency services.

B. The MCHIP licensee shall provide clear and understandable explanation to covered persons and providers of:

1. What constitutes emergency and urgent care;

2. The process for accessing emergency and urgent care;

3. The responsibility of the covered person for payment for nonemergency services rendered in a hospital emergency facility; and

4. Coverage for out-of-network emergency medical care when a covered person cannot reasonably access network services.

C. The MCHIP licensee shall require its providers to clearly notify covered persons of provisions for urgent care or emergency services when the physician is not available after hours.

D. The MCHIP licensee shall recognize primary care practitioners' authority to facilitate and authorize emergency services for covered persons.

E. Coverage of costs for emergency services shall be consistent with the evidence of coverage and shall not interfere with covered person access to care.

F. Covered persons shall be allowed immediate access to emergency services and access within no more than 24 hours for urgent care. Urgent care access may be provided sooner with appropriate authorization.

G. The MCHIP licensee shall monitor usage of urgent care and emergency service to determine if the services are understood and appropriately used by covered persons and providers.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

12VAC5-408-290 Health promotion

A. Annually, the MCHIP licensee shall develop and implement at least one health guideline for the prevention and early detection of illness and disease. Each written guideline shall:

1. Be available to covered persons upon request;

2. Describe the prevention or early detection intervention and the recommended frequency and condition under which the intervention is required; and

3. Document the scientific basis or authority upon which the guideline is based.

Guidelines may be specific to a defined population segment.

B. The MCHIP licensee shall distribute any preventive health guideline it develops and any updates to its providers as soon as practicable after development of the guideline.

C. The MCHIP shall regularly communicate with its covered persons to encourage the use of preventive health services.

D. At least annually, the MCHIP licensee shall measure covered person and provider compliance with the current preventive care guidelines. The MCHIP licensee may measure compliance by population segment if the guideline is specific to a population segment.

E. Providers who have appropriate knowledge shall be consulted in the adoption of the preventive health guidelines.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

Part V Clinical Performance Evaluation

12VAC5-408-300 Clinical performance evaluation systems

A. The MCHIP licensee shall have a system for the evaluation of the outcomes and processes of clinical care services delivered to the MCHIP's covered persons.

B. The MCHIP licensee shall adopt a nationally recognized clinical performance evaluation system, such as the Health Plan Employer Data and Information Set (HEDIS), that analyzes data based upon selected performance factors or shall establish a clinical performance evaluation system that uses data collection, quantitative measures, and analysis to monitor quality improvement activities.

C. The MCHIP licensee shall notify the department regarding its adoption of a nationally recognized clinical performance evaluation system, such as HEDIS, or that it has chosen to establish its own performance measurement system.

MCHIP licensees that choose not to adopt a nationally recognized system shall provide justification to the department of their choice of performance measurement selections for the department's approval.

D. The MCHIP licensee shall annually evaluate its performance in at least three of the areas of clinical care shown below:

1. Primary care services;

2. High volume specialty services;

3. Behavioral health services; and

4. Institutional health services including inpatient hospital care, home health services, skilled nursing facility services and ambulatory surgery.

If HEDIS measures are used to assess clinical performance, the MCHIP licensee shall substitute the HEDIS "Effectiveness of Care" measures for those areas listed in subdivisions 1 through 4 of this subsection.

E. The performance measurement indicators chosen by the MCHIP licensee shall:

1. Be objective and quantifiable;

2. Be based upon current and reliable scientific information;

3. Have an established goal or benchmark;

4. Effectively measure performance indicators; and

5. Have priority areas for measuring outcomes of clinical care and be reflective of industry-wide performance measurement goals.

F. The MCHIP licensee shall implement ways to improve its performance based on an analysis of its clinical performance measurements.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

12VAC5-408-310 Data collection and submission

A. Data collected and analyzed for clinical service evaluation shall be:

1. From the covered person population areas appropriate for the MCHIP to assess including: (i) high risk and high volume areas, (ii) areas where clinical problems are expected or have occurred in the past, (iii) areas that have the potential for adverse health outcomes, and (iv) areas where preventive health measures may have an impact;

2. Collected using processes that are methodologically sound;

3. Valid, reliable, complete and timely;

4. Analyzed quantitatively by personnel qualified to evaluate the data for clinical quality improvement; and

5. Protected for confidentially, easily retrievable, and transmitted for appropriate release to external parties.

B. The MCHIP licensee may permit appropriate organizations with which it contracts to collect and analyze relevant performance evaluation data and to release that data to the department or to its designee.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

Part VI Delegated Services

12VAC5-408-320 Delegated services

A. If the MCHIP licensee contracts for any of the following services, it shall retain accountability for the oversight of those services:

1. Quality assurance activities;

2. Credentialing and recredentialing;

3. Covered person education, communication and satisfaction;

4. Utilization management;

5. Health promotion;

6. Records management;

7. Data management;

8. Providers and provider networks;

9. Claims administration; or

10. Pharmacy benefits.

B. The MCHIP licensee shall establish and implement written procedures to evaluate the effectiveness of any delegated service.

C. The MCHIP licensee shall require the delegated service entity to maintain documentation of its compliance with this chapter, its agreement with the MCHIP licensee to provide services, and any applicable state and federal laws.

D. Data and information exchanged between the delegated service entity and the plan shall be accomplished in a manner that is timely, efficient, and effective.

E. The MCHIP licensee shall require the delegated service entity to provide for timely and efficient access by state examiners to data, records, and personnel necessary to determine compliance with this chapter.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

12VAC5-408-330 Written agreement

A. There shall be a written agreement signed by the MCHIP licensee and the delegated service entity that describes the:

1. Delegated service or services;

2. Responsibilities of the MCHIP and the delegated service entity and the remedies available to the MCHIP if the delegated service entity does not fulfill its obligations; and

3. Frequency of reporting to the MCHIP licensee and the process by which the MCHIP will evaluate the delegated service entity's performance.

B. The MCHIP licensee shall ensure that the covered persons' continuity of care is not disrupted because of changes made in the written agreement between the MCHIP licensee and the delegated service entity or because the relationship, as provided for in the agreement, is terminated.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

12VAC5-408-340 Exchange of information

A. If the delegated services are health care services, then the delegated services entity or the MCHIP licensee shall make the following information available if requested by the MCHIP's covered persons:

1. The procedures for filing complaints and appeals;

2. The utilization management decision process;

3. The process for appealing claims denials;

4. How to access emergency and urgent care;

5. How to obtain services not covered in the delegated health services' benefit package;

6. The process for changing from one practitioner to another;

7. Orientation process for new covered persons;

8. Covered person participation opportunities; and

9. Participating practitioners and providers.

B. If the delegated services are health care services, then the delegated service entity or the MCHIP licensee shall also inform the MCHIP's providers of at least the following:

1. Opportunities for provider involvement;

2. MCHIP licensee expectations of providers in achieving quality assurance program goals;

3. Provider credentialing process;

4. Procedures for complaints and appeals;

5. Process for utilization management decisions; and

6. Procedures to approve covered person access to emergency and urgent care.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

12VAC5-408-350 Quality assurance program

A. As it pertains to the covered persons, the MCHIP licensee shall integrate monitoring of the delegated service entity with respect to the following activities within its quality assurance program:

1. Quality assurance program activities;

2. Quality assurance plan measures; and

3. Complaint and appeals processes.

B. When the MCHIP's licensee's expectations have not been met, the MCHIP licensee shall require the delegated service entity to provide:

1. A corrective action plan that addresses areas where performance expectations have not been met; and

2. Evidence that corrective action was taken in keeping with corrective action plans.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

Part VII Utilization Review and Management

12VAC5-408-360 Utilization review and management

A. The MCHIP licensee shall have a utilization review and management process that complies with the requirements of §§ 32.1-137.7 through 32.1-137.16 of the Code of Virginia and this chapter. The process shall be managed by a licensed physician.

B. In developing its utilization review program, the MCHIP licensee shall utilize the applicable utilization review and management standards of the American Accreditation HealthCare Commission/URAC or the National Committee for Quality Assurance or other nationally recognized accrediting body acceptable to the department, as the criteria for determining compliance with the utilization management and review requirements of this section except in those instances in which state requirements in law or regulation are more stringent. Applicable utilization review and management standards are those included in an accreditation or certification program for a specific type of MCHIP, such as health maintenance organizations or preferred provider organizations, or for utilization review entities such as private review agents licensed in Virginia, to which MCHIPs may delegate utilization review and management services.

C. The MCHIP licensee, or its contracted private review agent or other delegated service entity for utilization review and management services, may demonstrate compliance with the utilization management and review requirements of this section by attaining accreditation or certification with the American Accreditation HealthCare Commission/URAC, the National Committee for Quality Assurance, or other nationally recognized accrediting body with comparable standards for utilization review accepted by the department. The department may require the MCHIP to demonstrate compliance with particular requirements of §§ 32.1-137.7 through 32.1-137.16 of the Code of Virginia, as well as any other pertinent sections, and this chapter that are more stringent than the applicable accreditation requirements. The department may provide a checklist or other standardized method by which MCHIP licensees may demonstrate compliance with the more stringent requirements.

D. An MCHIP licensee that is not accredited by a nationally recognized accrediting body and accepted by the department shall be subject to the triennial comprehensive onsite examination requirements of 12VAC5-408-90 for purposes of demonstrating compliance with the utilization review and management requirements of this section.

E. The purpose of the utilization review process shall be to monitor access to and utilization of health care services with the process ensuring that the conduct of utilization review is:

1. Impartial, timely, consistent and based upon supportive medical evidence;

2. Performed by appropriately qualified health personnel;

3. Comprehensive in assuring that good faith efforts to obtain all information necessary to make utilization review decisions are made;

4. Evaluated routinely so that program changes that determine the necessity, appropriateness, efficiency and efficacy of health care services provided by the MCHIP licensee can be made as a result of the evaluation; and

5. Reported annually to the MCHIP licensee's governing body.

F. In addition, the utilization review process shall:

1. Allow for flexibility, taking into account individual cases when appropriate;

2. Provide avenues for provider input into the establishment of clinical guidelines and protocols;

3. Afford opportunity for reconsideration and appeal of adverse determinations in a manner that is easily understood and accessed by covered persons and providers; and

4. Be coordinated with other components of the MCHIP that use or could benefit from utilization review data.

G. The utilization review process shall be based upon a written plan that is reviewed annually and that shall contain, at a minimum:

1. A description of the scope of the utilization review process, both internal and external;

2. A description of the organizational responsibilities for utilization review including the qualifications of utilization review personnel;

3. The clinical review guidelines, standards, and protocols which are applied in utilization review determinations;

4. Mechanisms to evaluate uniform application of guidelines and to determine the necessity for case-by-case decision making;

5. Procedures for soliciting and implementing provider input in the development of guidelines as well as evaluating provider usage of the guidelines;

6. A description of the process for monitoring over utilization and under utilization;

7. Provisions for notice to covered persons and providers regarding any need for precertification, concurrent certification, or retrospective review as a prerequisite for approval of payment or access to service;

8. Procedures for reconsideration of adverse decisions and appeals including expedited appeals;

9. Guidelines for the delegation of utilization review to external entities and the expectations for that delegation;

10. Guidelines for the notification in clear and understandable terms of the reasons for denial of services or payments to providers and subscribers;

11. Mechanisms for review and implementation of experimental treatments and new technology;

12. Mechanisms for soliciting and evaluating provider and covered person satisfaction with utilization review determinations and the MCHIP licensee's appeal process and implementing mechanisms to address areas of dissatisfaction; and

13. Procedures for the maintenance of records required under § 32.1-137.16 of the Code of Virginia.

History

• Statutory Authority: § 32.1-137.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 7, eff. January 20, 2000; Errata, 16:7 VA.R. 837 December 20, 1999; amended, Virginia Register Volume 18, Issue 8, eff. January 30, 2002.

Chapter 410 Regulations for the Licensure of Hospitals in Virginia

Article 1 Definitions

12VAC5-410-10 Definitions

As used in this chapter, the following words and terms shall have the following meanings unless the context clearly indicates otherwise:

"ACIP" means the Advisory Committee on Immunization Practices of the CDC.

"Activity of daily living" or "ADL" has the same meaning as ascribed to the term in § 32.1-137.08 A of the Code of Virginia.

"Board" means the State Board of Health.

"Business day" means a day that is not a Saturday, Sunday, legal holiday, or day on which the OLC is closed. For the purposes of this chapter, a day on which the Governor authorizes the closing of the state government is considered a legal holiday.

"Campus" means the physical area that is immediately adjacent to the hospital's main buildings, other areas and structures not strictly contiguous to the main buildings but located within 250 yards of the main buildings, and any other areas determined on an individual case basis by the OLC, in accordance with 42 CFR 431.65, to be part of the hospital's campus.

"Care provider" has the same meaning as ascribed to the term in § 32.1-137.08 A of the Code of Virginia.

"CDC" means the Centers for Disease Control and Prevention.

"Certified nursing facility" has the same meaning as ascribed to the term in § 32.1-123 of the Code of Virginia.

"Certified sexual assault nurse examiner" means a nurse who is board certified by the International Association of Forensic Nurses as either a Sexual Assault Nurse Examiner-Pediatric (SANE-P) or a Sexual Assault Nurse Examiner-Adult/Adolescent (SANE-A).

"Chief executive officer" means a job descriptive term used to identify the individual appointed by the governing body to act on its behalf in the overall management of the hospital. Job titles may include administrator, superintendent, director, executive director, president, vice-president, and executive vice-president.

"CMS" means the Centers for Medicare and Medicaid Services.

"Commissioner" means the State Health Commissioner.

"Consultant" means one who provides services or advice upon request.

"Department" means an organized section of the hospital.

"Designated support person" or "DSP" has the same meaning as ascribed to the term in § 32.1-137.08 A of the Code of Virginia and is not a visitor.

"Direction" means authoritative policy or procedural guidance for the accomplishment of a function or activity.

"Emergency department" means a department of the hospital that provides emergency services and is located on or within a 35-mile radius of the campus of the hospital.

"Facilities" means buildings, equipment, and supplies necessary for implementation of services by personnel.

"General hospital" means a hospital with an organized medical staff; with permanent facilities that may include inpatient beds; and with medical services, including physician services, dentist services, and continuous nursing services, to provide diagnosis and treatment for patients who have a variety of medical and dental conditions that may require various types of care, such as medical, surgical, and maternity.

"General hospital accrediting organization" means the Accreditation Commission for Health Care, the Center for Improvement in Healthcare Quality, DNV - Healthcare, the Joint Commission, or any accrediting organization that has been granted deeming authority for hospitals by CMS.

"Home health services" means a formally structured organizational unit of the hospital that is designed to provide health services to patients in their place of residence and that meets Part II (12VAC5-381-150 et seq.) of the Regulations for the Licensure of Home Care Organizations.

"Hospital" has the same meaning ascribed to the term in § 32.1-123 of the Code of Virginia and includes general hospitals and outpatient surgical hospitals.

"Inspector" means an individual employed by or contracted by the Virginia Department of Health and designated by the commissioner to conduct inspections, investigations, or evaluations.

"Intelligent personal assistant" means a combination of an electronic device and a specialized software application designed to assist users with basic tasks using a combination of natural language processing and artificial intelligence, including combinations known as digital assistants or virtual assistants.

"Long-term care nursing unit" means an organized jurisdiction of nursing service in which nursing services are provided on a continuous basis.

"Medical" means pertaining to or dealing with the healing art and the science of medicine.

"Nursing home" has the same meaning as ascribed to the term in § 32.1-123 of the Code of Virginia.

"Nursing services" means patient care services pertaining to the curative, palliative, restorative, or preventive aspects of nursing that are prepared or supervised by a registered nurse.

"OLC" means the Office of Licensure and Certification of the Virginia Department of Health.

"Operating room" means a room in a hospital designated for the performance of surgery.

"Organized" means administratively and functionally structured.

"Organized medical staff" means a formal organization of physicians and dentists with the delegated responsibility and authority to maintain proper standards of medical care and to plan for continued betterment of that care. Organized medical staff may include other practitioners, including independent practice midwives.

"Outpatient surgical hospital" means a hospital that primarily provides facilities for the performance of surgical procedures on outpatients. Such patients may require treatment in a medical environment exceeding the normal capability found in a physician's office, but do not require inpatient hospitalization.

"Outpatient surgical hospital accrediting organization" means the Accreditation Commission for Ambulatory Health Care, the Accreditation Commission for Health Care, the American Association for Accreditation of Ambulatory Surgery Facilities, the Joint Commission, or any accrediting organization that has been granted deeming authority for ambulatory surgical centers by CMS.

"Ownership/person" means any individual, partnership, association, trust, corporation, municipality, county, governmental agency, or any other legal or commercial entity that owns or controls the physical facilities or manages or operates a hospital.

"Person with a disability" has the same meaning as ascribed to the term in § 32.1-137.08 A of the Code of Virginia.

"Rural hospital" means any general hospital in a county classified by the federal Office of Management and Budget (OMB) as rural, any hospital designated as a critical access hospital, any general hospital that is eligible to receive funds under the federal Small Rural Hospital Improvement Grant Program, or any general hospital that notifies the commissioner of its desire to retain its rural status when that hospital is in a county reclassified by the OMB as a metropolitan statistical area as of June 6, 2003.

"Service" means a functional division of the hospital and is also used to indicate the delivery of care.

"Smoke evacuation system" means the same as that term is defined in § 32.1-127 B 32 of the Code of Virginia.

"Special care unit" means an appropriately equipped area of the hospital where there is a concentration of physicians, nurses, and others who have special skills and experience to provide optimal medical care for patients assigned to the unit.

"Staff privileges" means authority to render medical care in the granting institution within well-defined limits based on the individual's professional license and the individual's experience, competence, ability, and judgment.

"Support and assistance necessary due to the specifics of the person's disability" has the same meaning as ascribed to the term in § 32.1-137.08 A of the Code of Virginia.

"Surgery" has the same meaning as ascribed to the term in § 54.1-2400.01:1 A of the Code of Virginia.

"Unit" means a functional division or facility of the hospital.

"Urine drug screening" means a chemical analysis intended to test patients for the presence of multiple drugs, including cocaine, opioids, and phencyclidine.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 1.1, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 11, Issue 16, eff. June 1, 1995; Volume 21, Issue 12, eff. May 9, 2005; Volume 23, Issue 10, eff. March 1, 2007; Volume 29, Issue 19, eff. June 20, 2013; Volume 37, Issue 14, eff. March 31, 2021; Volume 41, Issue 17, eff. May 22, 2025; Volume 42, Issue 1, eff. September 24, 2025; Volume 42, Issue 5, eff. November 19, 2025; Volume 42, Issue 18, eff. June 4, 2026.

Article 2 General Information

12VAC5-410-20 Exceptions; variances

Article 2 General Information

A. In accordance with the § 32.1-124 of the Code of Virginia the provisions of this chapter shall not be applicable to:

1. A dispensary or first aid facility maintained by any commercial or industrial plant, educational institution or convent;

2. An institution licensed by the State Mental Health, Mental Retardation and Substance Abuse Services Board;

3. An institution or portion thereof licensed by the State Board of Social Services;

4. A hospital owned or operated by an agency of the Commonwealth or of the United States government; or

5. An office of one or more physicians or surgeons unless such office is used principally for performing surgery as defined in 12VAC5-410-10 of this chapter.

B. In accordance with § 32.1-128 of the Code of Virginia nothing in these rules and regulations shall be construed to authorize or require the interference with the supervision, regulation, or treatment of residents, patients, or personnel of any institution operated by and for the adherents of any well-recognized church or denomination who rely upon treatment by mental or spiritual means without the use of any drug or material remedy, provided such institution complies with applicable statutes and regulations on sanitation, life safety and construction design.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 1.2, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-30 Allowable variances

A. Upon the finding that the enforcement of one or more of these regulations would be clearly impractical, the commissioner shall have the authority to waive, either temporarily or permanently, the enforcement of one or more of these regulations, provided safety and patient care and services are not adversely affected.

B. Modification of any individual standard herein, for experimental or demonstrative purposes, or any other purposes, shall require advance written approval from the OLC.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 1.3, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 23, Issue 10, eff. March 1, 2007.

Article 3 Procedures for Licensure or License Renewal

12VAC5-410-40 General

Article 3 Procedures for Licensure or License Renewal

No person, as defined in 12VAC5-410-10, shall establish, conduct, maintain, or operate in this State any hospital as defined and included within provisions of this chapter without having obtained a license. Any person establishing, conducting, maintaining, or operating a hospital without a license shall be guilty of a Class 6 felony.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 1.4, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-50 Classification

Hospitals to be licensed shall be classified as general hospitals or outpatient surgical hospitals defined by 12VAC5-410-10.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 1.5, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 42, Issue 18, eff. June 4, 2026.

12VAC5-410-60 Separate license

A. A separate license shall be required by hospitals maintained on separate campuses even though the hospitals are operated under the same management. Separate license is not required for separate buildings on the same campus or within the same complex of buildings or for an emergency department of a general hospital.

B. Hospitals that have separate organized sections, units, or buildings to provide services of a classification covered by provisions of other state statutes or regulations may be required to have an additional applicable license for that type or classification of service (e.g., psychiatric, nursing home, home health services, and outpatient surgery).

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 1.6, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 29, Issue 19, eff. June 20, 2013; Volume 42, Issue 18, eff. June 4, 2026.

12VAC5-410-70 Request for issuance

A. Hospital licenses shall be issued by the commissioner, but all requests for licensing shall be submitted initially to the OLC. The procedure for obtaining the license shall include the following steps:

1. Request for application forms shall be made in writing to the OLC;

2. Application for license or license renewal to establish or maintain a hospital shall be made and submitted to the OLC;

3. All categories of inpatient beds shall be included on the hospital application for licensure in order for the OLC to have an accurate and complete record of the total bed capacity of the facility;

4. Application for initial license, change in license, or license renewal shall be accompanied by a check or money order for the service charge, payable to the OLC; and

5. Application for initial license of a hospital or for additions to an existing licensed hospital must be accompanied by evidence of approval from a representative of the State Fire Marshal and a copy of the occupancy permit issued by the local building official.

6. Application for initial license of a hospital shall include a statement of any agreement made with the commissioner as a condition for Certificate of Public Need approval to provide a level of care at a reduced rate to indigents or accept patients requiring specialized care.

Any initial license issued to any hospital that made such agreement as a condition of its Certificate of Public Need approval shall not be renewed without demonstrating prior to or at the time of applying for license renewal that it is substantially complying with its agreement.

B. The renewal of a hospital license shall be conditioned upon the up-to-date payment of any civil penalties owed as a result of willful refusal, failure, or neglect to honor certain conditions established in their award of a Certificate of Public Need pursuant to § 32.1-102.4 F of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 1.7, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 11, Issue 16, eff. June 1, 1995; Volume 18, Issue 10, eff. February 28, 2002; Volume 23, Issue 10, eff. March 1, 2007.

12VAC5-410-80 Service charge

A. In accordance with § 32.1-130 of the Code of Virginia, the following service charge shall be made:

0 to 50 beds -- $75

51 to 333 beds -- $1.50 per bed

334 or more -- $500

B. The hospital shall not be required to pay a service charge on hospital beds in a category that requires separate license by the OLC or another state agency (i.e., psychiatric, nursing home).

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 1.8, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 23, Issue 10, eff. March 1, 2007.

12VAC5-410-90 License expiration

Licenses shall expire as specified or at midnight December 31 following date of issue, whichever is first, and shall be renewable annually, upon filing of application and payment of service charge, unless cause appears to the contrary.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 1.9, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-100 Name

Every hospital shall be designated by a permanent and appropriate name that shall appear on the application for license.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 1.10, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 23, Issue 10, eff. March 1, 2007; Volume 42, Issue 18, eff. June 4, 2026.

12VAC5-410-110 Bed capacity

A. Each license issued by the commissioner shall specify the maximum allowable number of beds. The number of beds allowed shall be determined by the OLC and shall so appear on the license issued by the OLC.

B. Request for licensed bed increase or decrease shall be made in writing to the OLC. No increase will be granted without an approved Certificate of Public Need.

C. Hospitals shall be exempt from the requirement to obtain a license to add temporary beds, for a period of no more than 30 days, when the commissioner has determined that a natural or man-made disaster has caused the evacuation of a hospital or nursing home and that a public health emergency exists due to a shortage of hospital or nursing home beds.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 1.11, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 11, Issue 16, eff. June 1, 1995; Volume 23, Issue 10, eff. March 1, 2007; Volume 35, Issue 24, eff. August 23, 2019.

12VAC5-410-120 Posting of license

The hospital license issued by the commissioner shall be framed and posted conspicuously on the premises either in the main entrance to the hospital or in a place visible from that main entrance.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 1.12, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-130 Surrender of license; mid-term change of license

A. Upon revocation or suspension of a license, the hospital shall surrender its license to the OLC.

B. The hospital shall notify the director of the OLC in writing by submitting a mid-term change application no fewer than 30 calendar days in advance of implementing any of the following:

1. Change of location of the hospital, including change of location of any emergency department, not located on the hospital's campus;

2. Change of ownership of the hospital;

3. Change of operator of the hospital;

4. Change of name of the hospital;

5. Change of bed capacity, except as provided in 12VAC5-410-110 C, which shall be accompanied by an approved Certificate of Public Need if the requested change is for an increase in bed capacity;

6. Change of services being provided, including any proposed addition or discontinuation, regardless of whether licensure is required for the service; or

7. Closure of the hospital.

C. The OLC shall:

1. Consider the submission date of a mid-term change application to be the date it is postmarked or the date it is received, whichever is earlier; and

2. Notify the licensee in writing if the commissioner will issue a changed license.

D. The commissioner's issuance of a changed license to the hospital shall satisfy the requirements of subdivision C 2 of this section.

E. Upon receipt of the changed license, the licensee shall return its prior license issued by the commissioner to the OLC and destroy any copies of the prior license.

F. A license may not be transferred or assigned. The commissioner may not issue a changed license in response to a change of operator of the hospital, but shall instead require the hospital to obtain a new license. If the hospital intends to implement a change of operator, it shall:

1. File for a new license in accordance with 12VAC5-410-70 no fewer than 30 calendar days in advance of any change of operator; and

2. Upon receipt of the new license, surrender its prior license issued by the commissioner to the OLC and destroy any copies of the prior license.

G. If the hospital is closing or will otherwise no longer be operational, it shall:

1. Notify patients, legal representatives, and the OLC no fewer than seven calendar days prior to closing or ceasing operations where all clinical records are to be located following closure or cessation of operations; and

2. Surrender its license to the OLC and destroy all copies of its license no more than five calendar days after the hospital closes or ceases operations.

H. The OLC shall determine if any changes listed in subsection B of this section affect the terms of the license or the continuing eligibility for a license. An inspector may inspect the hospital during the process of evaluating a proposed change.

History

• Statutory Authority: §§ 32.1-12, 32.1-127, and 32.1-132 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 1.13, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 11, Issue 16, eff. June 1, 1995; Volume 23, Issue 10, eff. March 1, 2007; Volume 35, Issue 24, eff. August 23, 2019; Volume 42, Issue 18, eff. June 4, 2026.

12VAC5-410-140 Inspection procedure

A. The OLC shall make periodic unannounced on-site inspections of a hospital as necessary but not less frequently than biennially. The OLC may make on-site inspections of applicants for licensure. Compliance with all standards shall be determined by the OLC.

B. The hospital or applicant shall:

1. Make available to the inspector any requested records;

2. Permit an inspector to enter upon and into its property to inspect or investigate as the inspector reasonably deems necessary in order to determine the state of compliance with the provisions of this chapter and all laws administered by the board; and

3. Allow the inspector access to interview the agents, employees, independent contractors, patients, legal representatives, patient family members, and any person under the hospital's or applicant's control, direction, or supervision.

C. After the on-site inspection, the inspector shall:

1. Discuss the findings of the inspection with the chief executive officer or the chief executive officer's designee; and

2. Provide a written inspection report to the chief executive officer or the chief executive officer's designee.

D. If the OLC cites one or more licensing violations in the written inspection report, the chief executive officer or the chief executive officer's designee shall submit a plan of correction in accordance with 12VAC5-410-150.

E. The OLC may presume that a general hospital deemed by a general hospital accrediting organization and certified for participation in Title XVIII of the Social Security Act (42 USC § 301 et seq.) generally meets the requirements of Part II (12VAC5-410-170 et seq.) of this chapter provided the following conditions are met:

1. The general hospital provides to the OLC, upon request, a copy of the most current accreditation survey findings made by the general hospital accrediting organization; and

2. The general hospital notifies the OLC within 10 days after receipt of any notice of revocation or denial of accreditation by the general hospital accrediting organization.

F. The OLC may presume that an outpatient surgical hospital deemed by an outpatient surgical hospital accrediting organization and certified for participation in Title XVIII of the Social Security Act (42 USC § 301 et seq.) generally meets the requirements of Part IV (12VAC5-410-1150 et seq.) of this chapter provided the following conditions are met:

1. The outpatient surgical hospital provides to the OLC, upon request, a copy of the most current accreditation survey findings made by the outpatient surgical hospital accrediting organization; and

2. The outpatient surgical hospital notifies the OLC within 10 days after receipt of any notice of revocation or denial of accreditation by the outpatient surgical hospital accrediting organization.

G. The OLC may presume that a unit or part of a general hospital licensed or certified by another state agency or another section, bureau, or division of the OLC meets the requirements of Part II (12VAC5-410-170 et seq.) of this chapter for that specific unit or part provided the following conditions are met:

1. The general hospital provides the OLC, upon request, a copy of the most current inspection report made by the other state agency; and

2. The general hospital notifies the OLC within 10 days after receipt of any notice of revocation or suspension by the other state agency.

H. The OLC may presume that a unit or part of an outpatient surgical hospital licensed or certified by another state agency or another section, bureau, or division of the OLC meets the requirements of Part IV (12VAC5-410-1150 et seq.) of this chapter for that specific unit or part provided the following conditions are met:

1. The outpatient surgical hospital provides the OLC, upon request, a copy of the most current inspection report made by the other state agency; and

2. The outpatient surgical hospital notifies the OLC within 10 days after receipt of any notice of revocation or suspension by the other state agency.

I. Notwithstanding any other provision of this chapter to the contrary, if the OLC finds, after inspection, violations pertaining to environmental health or life safety, the hospital shall receive a written licensing report of such findings. The hospital shall be required to submit a plan of correction in accordance with provisions of 12VAC5-410-150.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 1.14, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 11, Issue 16, eff. June 1, 1995; Volume 23, Issue 10, eff. March 1, 2007; Volume 42, Issue 18, eff. June 4, 2026.

12VAC5-410-150 Plan of correction

A. Upon receipt of a written inspection report, the chief executive officer or the chief executive officer's designee shall prepare a written plan of correction addressing each licensing violation cited at the time of inspection.

B. The chief executive officer or the chief executive officer's designee shall submit to the OLC a written plan of correction no more than 15 business days after receipt of the inspection report. The plan of correction shall contain, for each licensing violation cited:

1. A description of the corrective action to be taken and the position title of the employees to implement the corrective action. If employees share the same position title, the chief executive officer or the chief executive officer's designee shall assign the employees a unique identifier to distinguish them;

2. The expected correction date, not to exceed 45 business days from the exit date of the inspection; and

3. A description of the measures implemented to prevent a recurrence of each licensing violation.

C. The chief executive officer or the chief executive officer's designee shall ensure that the person responsible for the validity of the plan of correction signs, dates, and indicates their title on the plan of correction.

D. The OLC shall notify the chief executive officer or the chief executive officer's designee, in writing, if the OLC determines any item in the plan of correction is unacceptable.

E. The OLC may conduct an inspection to verify that any portion of a plan of correction has been implemented.

F. The chief executive officer or the chief executive officer's designee shall ensure the plan of correction is implemented and monitored so that compliance is maintained.

G. The commissioner may deny licensure or renewal of licensure if the chief executive officer or the chief executive officer's designee fails to submit an acceptable plan of correction or fails to implement an acceptable plan of correction.

H. The OLC shall consider the submission date of a plan of correction to be the date the plan of correction is postmarked or the date it is received, whichever is earlier.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 1.15, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 11, Issue 16, eff. June 1, 1995; Volume 23, Issue 10, eff. March 1, 2007; Volume 42, Issue 18, eff. June 4, 2026.

12VAC5-410-160 Disciplinary action

A. A hospital may not:

1. Violate the provisions of this chapter or Article 1 (§ 32.1-123 et seq.) of Chapter 5 of Title 32.1 of the Code of Virginia;

2. Permit, aid, or abet the commission of any illegal act in the hospital;

3. Engage in a pattern of violations pursuant to § 38.2-3445.01 of the Code of Virginia; or

4. Engage in a pattern of violations of § 38.2-3407.15 B 13 of the Code of Virginia.

B. The commissioner may:

1. For each violation of subsection A of this section:

a. Deny, revoke, or suspend the license to operate a hospital, in accordance with the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia);

b. Refer a hospital for criminal prosecution pursuant to § 32.1-27 A of the Code of Virginia; or

c. Petition an appropriate court for an injunction, mandamus, or other appropriate remedy or imposition of a civil penalty against a hospital pursuant to § 32.1-27 B or C of the Code of Virginia;

2. For each violation of subsection A of this section by or occurring in a long-term care nursing unit of a general hospital if that unit is a certified nursing facility:

a. Restrict or prohibit new admissions to the long-term care nursing unit in accordance with the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia);

b. Petition an appropriate court for imposition of a civil monetary penalty against a hospital pursuant to § 32.1-27.1 A of the Code of Virginia; or

c. Petition an appropriate court for appointment of a receiver for the long-term care nursing unit pursuant to § 32.1-27.1 B of the Code of Virginia; and

3. For each violation of subdivision A 3 of this section, levy a fine upon the hospital in an amount not to exceed $1,000 per violation, in accordance with the Administrative Process Act.

C. Suspension of a license shall in all cases be for an indefinite time.

D. For each violation of subsection A of this section and with the consent of the person who has violated subsection A of this section, the board may provide, in an order issued by the board, for the payment of civil charges for past violations in specific sums, which may not exceed the limits specified in § 32.1-27 of the Code of Virginia or if applicable, the limits specified in § 32.1-27.1 of the Code of Virginia.

E. Upon receipt of a completed application and a nonrefundable service charge, the commissioner may issue a new license to a hospital that has had its license revoked if the commissioner determines that:

1. The conditions upon which revocation was based have been corrected; and

2. The applicant is in compliance with this chapter, Article 1 (§ 32.1-123 et seq.) of Chapter 5 of Title 32.1 of the Code of Virginia, and all other applicable state and federal laws and regulations.

F. Upon receipt of a completed application, the commissioner may partially or completely restore a suspended license to a hospital if the commissioner determines that:

1. The conditions upon which suspension was based have been completely or partially corrected; and

2. The interests of the public will not be jeopardized by resumption of operation.

G. The commissioner may not require an additional service charge for restoring a license pursuant to subsection F of this section.

H. The hospital shall submit evidence relevant to subdivisions E 1, E 2, F 1, and F 2 of this section that is satisfactory to the commissioner or the commissioner's designee. The commissioner or the commissioner's designee may conduct an inspection prior to making a determination.

History

• Statutory Authority: §§ 32.1-12, 32.1-27, 32.1-27.1, 32.1-127, 32.1-135, 32.1-137.07, and 38.2-3407.15 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 1.16, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 42, Issue 18, eff. June 4, 2026.

Article 1 Organization and Management

12VAC5-410-170 Ownership

Article 1 Organization and Management

A. There shall be disclosure of hospital ownership. In the case of corporations, all individuals or entities holding 5.0% or more of the total ownership shall be identified by name and address.

B. When the owner delegates the operation of a hospital to an individual, corporation or other legal entity by management contract or lease agreement, subsection A shall also be applicable to the operator.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.1, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-180 Governing body

A. Each hospital shall have an organized governing body or other legal entity responsible for the management and control of the operation.

The governing body or other legal entity may be an individual, group, corporation or governmental agency.

B. The governing body shall be responsible for insuring compliance with these rules and regulations.

C. The governing body shall provide facilities, personnel and other resources necessary to meet patient and program needs.

D. The governing body shall adopt and maintain written bylaws, rules and regulations in accordance with legal requirements. A copy of said bylaws, rules and regulations including amendments or revisions thereto, shall be made available to the OLC on request.

E. The bylaws, rules and regulations shall include:

1. A statement of purpose;

2. A statement of qualifications for membership and method of selecting members of the governing body;

3. Provisions for the establishment, selection, term of office of committee members and officers;

4. Description of the functions and duties of the governing body, officers, and committees;

5. Specifications for the frequency of meetings, attendance requirements, provision for the order of business and the maintenance of written minutes;

6. A statement of the authority and responsibility delegated to the chief executive officer and to the medical staff;

7. Provision for the selection and appointment of medical staff and the granting of clinical privileges including the provision for current license to practice in Virginia.

8. Provision for the adoption of the medical staff bylaws, rules and regulations;

9. Provision of guidelines for the relationships among the governing body, the chief executive officers, and the medical staff.

10. A policy statement concerning the development and implementation of short- and long-range plans in accordance with Part III (12VAC5-410-650 et seq.) of this chapter.

11. A policy statement relating to conflict of interest on the part of members of the governing body, medical staff and employees who may influence corporate decisions.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.2, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 23, Issue 10, eff. March 1, 2007.

12VAC5-410-190 Chief executive officer

A. The chief executive officer shall be directly responsible to the governing body for the management and operation of the hospital and shall provide liaison between the governing body and the medical staff.

B. The chief executive officer, or his designee, shall ensure that families of patients who are potential donors are informed of the option of organ, tissue, and eye donation.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.3, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-200 Organization

A. The internal hospital organization shall be structured to include appropriate departments and services consonant with its statement of purpose.

B. Each hospital shall maintain clearly written definitions of its organization, authority, responsibility, and relationships.

C. Each hospital department and service shall maintain:

1. Clearly written definitions of its organization, authority, responsibility, and relationships; and

2. Written policies and procedures including:

a. Patient care where applicable;

b. Infection prevention;

c. Disaster preparedness; and

d. Facility security.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.4, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 28, Issue 2, eff. November 1, 2011.

12VAC5-410-210 Medical staff

A. Each hospital shall have an organized medical staff responsible to the governing body of the hospital for its own organized governance and all medical care provided to patients. Nothing in this subsection shall prevent hospitals that are a part of a hospital system from having a unified and integrated medical staff as permitted by 42 CFR 482.22(b)(4).

B. The medical staff shall be responsible to the hospital governing board and maintain appropriate standards of professional performance through staff appointment criteria, delineation of staff privileges, continuing peer review, and other appropriate mechanisms.

C. The medical staff, subject to approval by the governing body, shall develop bylaws incorporating details of the medical staff organization and governance, giving effect to its general powers, duties, and responsibilities including:

1. Methods of selection, election, or appointment of all officers and other executive committee members and officers;

2. Provisions for the selection and appointment of officers of departments or services specifying required qualifications;

3. The type, purpose, composition, and organization of standing committees;

4. Frequency and requirements for attendance at staff and departmental meetings;

5. An appeal mechanism for denial, revocation, or limitation of staff appointments, reappointments, and privileges;

6. Delineation of clinical privileges in accordance with the requirements of § 32.1-134.2 of the Code of Virginia;

7. Requirements regarding medical records;

8. A mechanism for utilization and medical care review; and

9. Such other provisions as shall be required by hospital or governmental rules and regulations.

D. A copy of approved medical staff bylaws and regulations and revisions thereto shall be made available to the OLC on request.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.5, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 23, Issue 10, eff. March 1, 2007; Volume 32, Issue 14, eff. April 22, 2016.

12VAC5-410-215 Financial assistance in general hospitals

A. As used in this section, "patient" and "uninsured patient" have the same meanings as ascribed to these terms in § 32.1-137.010 A of the Code of Virginia.

B. A general hospital shall make reasonable efforts to screen every uninsured patient to determine whether the individual is eligible for medical assistance pursuant to the state plan for medical assistance or for financial assistance under the general hospital's financial assistance policy.

C. A general hospital shall inform every uninsured patient who receives services at the general hospital and who is determined to be eligible for assistance under the general hospital's financial assistance policy of the option to enter into a payment plan with the general hospital.

1. A payment plan entered into pursuant to this subsection shall be provided to the patient in writing or electronically and shall provide for repayment of the cumulative amount owed to the general hospital.

2. The amount of monthly payments and the term of the payment plan shall be determined based upon the patient's ability to pay.

3. Any interest on amounts owed pursuant to the payment plan shall not exceed the maximum judgment rate of interest pursuant to § 6.2-302 of the Code of Virginia.

4. The general hospital may not charge any fees related to the payment plan.

5. The payment plan shall allow prepayment of amounts owed without penalty.

D. A general hospital shall develop a process by which either an uninsured patient who agrees to a payment plan pursuant to subsection C of this section or the general hospital may request and shall be granted the opportunity to renegotiate the payment plan.

1. Renegotiation shall include opportunity for a new screening in accordance with subsection B of this section.

2. A general hospital may not charge any fees for renegotiation of a payment plan pursuant to this subsection.

E. A general hospital shall provide written information about:

1. The general hospital's charity care policies, including:

a. Policies related to free and discounted care;

b. Specific eligibility criteria for charity care; and

c. Procedures for applying for charity care;

2. The availability of a payment plan for the payment of debt owed to the general hospital pursuant to subsection C of this section; and

3. The renegotiation process described in subsection D of this section.

F. To provide the information required by subsection E of this section, a general hospital shall:

1. Post the information conspicuously in public areas of the general hospital, including admissions or registration areas, emergency departments, and associated waiting rooms;

2. Make the information available to:

a. A patient at the time of admission or discharge, or at the time services are provided; and

b. Persons with limited English proficiency in accordance with the U.S. Department of Health and Human Services Guidance to Federal Financial Assistance Recipients Regarding Title VI Prohibition Against National Origin Discrimination Affecting Limited English Proficient Persons (August 8, 2003, 68 FR 47311), if the general hospital is subject to the requirements of Title VI of the Civil Rights Act of 1964 (Pub. L. No. 88-352), as amended; and

3. Include the information:

a. With any billing statements sent to uninsured patients; and

b. On any website maintained by the general hospital.

G. Notwithstanding any other provision of law, a general hospital may not engage in any action described in § 501(r)(6) of the Internal Revenue Code as it was in effect on January 1, 2020, to recover a debt for medical services against any patient unless the general hospital has made all reasonable efforts to determine whether the patient:

1. Qualifies for medical assistance pursuant to the state plan for medical assistance; or

2. Is eligible for financial assistance under the general hospital's financial assistance policy.

H. Nothing in this section shall be construed to:

1. Prohibit a general hospital, as part of its financial assistance policy, from requiring a patient to:

a. Provide necessary information needed to determine eligibility for financial assistance under the general hospital's financial assistance policy, medical assistance pursuant to Title XVIII or XIX of the Social Security Act (42 USC § 301 et seq.), 10 USC § 1071 et seq., or other programs of insurance; or

b. Undertake good faith efforts to apply for and enroll in the programs of insurance for which the patient may be eligible as a condition of awarding financial assistance;

2. Require a general hospital to grant or continue to grant any financial assistance or payment plan pursuant to this section when:

a. A patient has provided false, inaccurate, or incomplete information required for determining eligibility for the general hospital's financial assistance policy; or

b. A patient has not undertaken good faith efforts to comply with any payment plan pursuant to this section; or

3. Prohibit the coordination of benefits as required by state or federal law.

History

• Statutory Authority: §§ 32.1-12, 32.1-127, 32.1-137.01, and 32.1-137.010 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 42, Issue 18, eff. June 4, 2026.

12VAC5-410-220 Organ donation

A. The hospital shall develop and implement a routine contact protocol for organ, tissue and eye donation in compliance with federal law and the regulations of the Centers for Medicare and Medicaid Services (CMS), particularly 42 CFR 482.45.

B. The protocol shall:

1. Ensure that the hospital collaborates with its designated organ procurement organization (OPO) to inform the family of each potential donor of the option of organ, tissue, and eye donation as well as the option to decline to donate;

2. Recite provisions of § 32.1-290.1 of the Code of Virginia specifying family members who are authorized to make an anatomical gift of all or part of the decedent's body for an authorized purpose and the order of priority of those family members who may make such gift; and

3. Include written procedures for organ, tissue, and eye donation. The procedures shall include:

a. Training of staff in organ, tissue, or eye donation;

b. A mechanism for informing the next of kin of the organ, tissue, and eye donation option;

c. Procedures to be employed when the hospital, consistent with the authority granted by § 32.1-292.1 of the Code of Virginia, deems it appropriate to conduct a reasonable search for a document of gift or other information identifying the bearer as a donor or as an individual who has refused to make an anatomical gift;

d. Provisions for the procurement and maintenance of donated organs, tissues, and eyes;

e. The name and telephone number of the local organ procurement agency, tissue or eye bank to be notified of potential donors; and

f. Documentation of the donation request in the patient's medical record.

C. The hospital shall have an agreement with an OPO certified by CMS:

1. To notify the OPO in a timely manner of all deaths or imminent deaths of patients in the hospital; and

2. Authorizing the OPO to determine the suitability of the decedent or patient for organ donation and the suitability for tissue and eye donation in the absence of a similar arrangement with any eye bank or tissue bank in Virginia certified by the Eye Bank Association of America or the American Association of Tissue Banks.

D. The hospital shall have an agreement with at least one tissue bank and at least one eye bank to cooperate in the retrieval, processing, preservation, storage, and distribution of tissues and eyes to ensure that all usable tissues and eyes are obtained from potential donors and to avoid interference with organ procurement.

E. The individual making contact with the family shall have completed a course in the methodology for approaching potential donor families and requesting organ or tissue donation that:

1. Is offered or approved by the OPO and designed in conjunction with the tissue and eye bank community; and

2. Encourages discretion and sensitivity according to the specific circumstances, views, and beliefs of the relevant family.

F. The hospital shall work cooperatively with its designated OPO in educating its staff on:

1. Donation issues;

2. The proper review of death records to improve identification of potential donors; and

3. The proper procedures for maintaining potential donors while necessary testing and placement of potential donated organs, tissues, and eyes take place.

G. The protocol shall be followed, without exception, unless the family of the relevant decedent or patient expresses opposition to organ donation, the chief administrative officer of the hospital or his designee knows of such opposition, and no donor card or other relevant document, such as an advance directive, can be found.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.6, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 17, Issue 1, eff. October 27, 2000; Volume 23, Issue 10, eff. March 1, 2007.

12VAC5-410-225 Hospitals; reports of threats or acts of violence against health care providers

A. For the purposes of this section:

"Employee of the hospital" or "employee" means an employee of the hospital or any health care provider credentialed by the hospital or engaged by the hospital to perform health care services on the premises of the hospital.

"Workplace violence" means any act of violence or threat of violence, without regard to the intent of the perpetrator, that occurs against an employee of the hospital while on the premises of such hospital and engaged in the performance of the employee's duties. "Workplace violence" includes (i) the threat or use of physical force against an employee that results in, or has a high likelihood of resulting in, injury, psychological trauma, or stress, regardless of whether physical injury is sustained, and (ii) any incident involving the threat of using dangerous weapons or using common objects as weapons or to cause physical harm, regardless of whether physical injury is sustained.

B. A hospital shall:

1. Establish a workplace violence incident reporting system, through which the hospital shall document, track, and analyze any incident of workplace violence reported.

2. Use the results of the analysis to make improvements in preventing workplace violence, including improvements achieved through continuing education in targeted areas, including (i) de-escalation training, (ii) risk identification, and (iii) violence prevention planning.

3. Clearly communicate the reporting system to all employees, including to any new employees at the employee orientation. The reporting system shall include guidelines on when and how to report incidents of workplace violence to the employer, security agencies, and appropriate law-enforcement authorities;

4. Record all reported incidents of workplace violence as voluntarily reported by an employee; and

5. Adopt a policy that prohibits any person from discriminating or retaliating against any employee of the hospital for reporting to, or seeking assistance or intervention from, the employer, security agencies, law-enforcement authorities, local emergency services organizations, government agencies, or others participating in any incident investigation. The policy shall comply with the provisions of § 40.1-27.3 of the Code of Virginia.

C. A hospital shall maintain the record of reported incidents of workplace violence made pursuant to subsection B of this section for at least two years and shall include in the record, at a minimum:

1. The date and time of the incident;

2. A description of the incident, including the job title of the affected employee;

3. Whether the perpetrator was a patient, visitor, employee, or other person;

4. A description of where the incident occurred;

5. Information relating the type of incident, including whether the incident involved (i) a physical attack without a weapon; (ii) an attack with a weapon or object; (iii) a threat of physical force or use of a weapon or other object with the intent to cause bodily harm; (iv) sexual assault or the threat of sexual assault; or (v) anything else not listed in subdivisions (i) through (iv);

6. The response to and any consequences of the incident, including (i) whether security or law enforcement was contacted and, if so, their response and (ii) whether the incident resulted in any change to hospital policy; and

7. Information about the individual who completed the report, including the individual's name, job title, and the date of completion.

D. A hospital shall:

1. Report the data collected and reported pursuant to subsection C of this section to the chief medical officer and the chief nursing officer of the hospital on, at a minimum, a quarterly basis; and

2. Send a report to the department on an annual basis that includes, at a minimum, the number of incidents of workplace violence voluntarily reported by an employee pursuant to subsection B of this section. A report made to the department pursuant to this subsection shall be aggregated to remove any personally identifiable information.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 42, Issue 5, eff. November 19, 2025.

12VAC5-410-227 Newborn safety devices

A general hospital that voluntarily installs a newborn safety device, as provided for in clause (c) of § 18.2-371 of the Code of Virginia, for the reception of children shall ensure that:

1. The device is located inside the hospital in an area that is conspicuous and visible to employees or personnel;

2. The device is staffed 24 hours a day by a health care provider;

3. The device is climate controlled and serves as a safe sleep environment for an infant;

4. The device is equipped with a dual alarm system that sounds 60 seconds after a child is placed in the device and automatically places a call to 911 if the alarm is not deactivated within 60 seconds from within the hospital;

5. The dual alarm system is visually checked at least two times per day and tested at least one time per week to ensure the alarm system is in working order;

6. The device automatically locks when a child is placed in the device; and

7. The device is identifiable by appropriate signage that shall include written and pictorial operational instructions.

History

• Statutory Authority: §§ 8.01-226.5:2, 32.1-12, and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 42, Issue 18, eff. June 4, 2026.

Article 2 Patient Care Services

12VAC5-410-230 Patient care management

A. All patients shall be under the care of a member of the medical staff.

B. Each hospital shall have a plan that includes effective mechanisms for the periodic review and revision of patient care policies and procedures.

C. Each hospital shall establish a protocol relating to the rights and responsibilities of patients based on 42 CFR 482.13. The protocol shall include a process reasonably designed to inform patients of patient rights and responsibilities. Patients shall be given a copy of patient rights and responsibilities upon admission.

D. No medication or treatment shall be given except on the signed order of a person lawfully authorized by state statute.

1. Hospital personnel, as designated in medical staff bylaws, rules and regulations, or hospital policies and procedures, may accept emergency telephone and other verbal orders for medication or treatment for hospital patients from physicians and other persons lawfully authorized by state statute to give patient orders.

2. As specified in the hospital's medical staff bylaws, rules and regulations, or hospital policies and procedures, emergency telephone and other verbal orders shall be signed within a reasonable period of time not to exceed 72 hours, by the person giving the order or, when such person is not available, cosigned by another physician or other person authorized to give the order.

E. Each hospital shall have a reliable method for identification of each patient, including newborn infants.

F. Each hospital shall include in its visitation policy a provision allowing each adult patient to receive visits from any individual from whom the patient desires to receive visits, subject to other restrictions contained in the visitation policy, including the patient's medical condition and the number of visitors permitted in the patient's room simultaneously.

During a declared public health emergency related to a communicable disease of public health threat, each hospital shall establish a protocol to allow patients to receive visits from a rabbi, priest, minister, or clergy member of a religious denomination or sect. Such protocol shall be consistent with guidance from the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services and subject to compliance with an executive order, order of public health, department guidance, or other applicable federal or state guidance having the effect of limiting visitation.

1. The protocol may restrict the frequency and duration of visits and may require visits to be conducted virtually using interactive audio or video technology.

2. The protocol may require the person visiting a patient pursuant to this subsection to comply with all reasonable requirements of the hospital adopted to protect the health and safety of the person, patients, and staff of the hospital.

G. Each hospital that is equipped to provide life-sustaining treatment shall develop a policy to determine the medical or ethical appropriateness of proposed medical care, which shall include:

1. A process for obtaining a second opinion regarding the medical and ethical appropriateness of proposed medical care in cases in which a physician has determined proposed care to be medically or ethically inappropriate;

2. Provisions for review of the determination that proposed medical care is medically or ethically inappropriate by an interdisciplinary medical review committee and a determination by the interdisciplinary medical review committee regarding the medical and ethical appropriateness of the proposed health care of the patient;

3. Requirements for a written explanation of the decision of the interdisciplinary medical review committee, which shall be included in the patient's medical record; and

4. Provisions to ensure the patient, the patient's agent, or the person authorized to make the patient's medical decisions in accordance with § 54.1-2986 of the Code of Virginia is informed of the patient's right to obtain the patient's medical record and the right to obtain an independent medical opinion and afforded reasonable opportunity to participate in the medical review committee meeting.

The policy shall not prevent the patient, the patient's agent, or the person authorized to make the patient's medical decisions from obtaining legal counsel to represent the patient or from seeking other legal remedies, including court review, provided that the patient, the patient's agent, person authorized to make the patient's medical decisions, or legal counsel provides written notice to the chief executive officer of the hospital within 14 days of the date of the physician's determination that proposed medical treatment is medically or ethically inappropriate as documented in the patient's medical record.

H. Each hospital shall establish a protocol requiring that, before a health care provider arranges for air medical transportation services for a patient who does not have an emergency medical condition as defined in 42 USC § 1395dd(e)(1), the hospital shall provide the patient or the patient's authorized representative with written or electronic notice that the patient (i) may have a choice of transportation by an air medical transportation provider or medically appropriate ground transportation by an emergency medical services provider and (ii) will be responsible for charges incurred for such transportation in the event that the provider is not a contracted network provider of the patient's health insurance carrier or such charges are not otherwise covered in full or in part by the patient's health insurance plan.

I. Each hospital shall provide written information about the patient's ability to request an estimate of the payment amount for which the participant will be responsible pursuant to § 32.1-137.05 of the Code of Virginia. The written information shall be posted conspicuously in public areas of the hospital, including admissions or registration areas, and included on any website maintained by the hospital.

J. Each hospital shall establish and implement policies to ensure the permissible access to and use of an intelligent personal assistant provided by a patient while receiving inpatient services. The policies shall ensure protection of health information in accordance with the requirements of the federal Health Insurance Portability and Accountability Act of 1996 (42 USC § 1320d et seq.).

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.7, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 19, Issue 1, eff. November 1, 2002; Errata, 19:3 VA.R. 549 October 21, 2002; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008; Volume 35, Issue 4, eff. November 14, 2018; Volume 35, Issue 21, eff. July 10, 2019; Volume 35, Issue 24, eff. August 23, 2019; Volume 36, Issue 23, eff. August 6, 2020; Volume 37, Issue 14, eff. March 31, 2021; Volume 42, Issue 18, eff. June 4, 2026.

12VAC5-410-235 Persons with a disability; designated support person in general hospitals

A. For the purposes of this section:

1. "Admission" means accepting a person for bed occupancy and care that is anticipated to span at least two midnights or for observation;

2. "General hospital" means a general hospital other than one that is certified as a long-term acute care hospital or specialty rehabilitation hospital.

B. A general hospital shall allow a person with a disability who requires support and assistance necessary due to the specifics of the person's disability to be accompanied by a DSP who will provide support and assistance necessary due to the specifics of the person's disability to the person with a disability during an admission.

1. In any case in which the duration of the admission lasts more than 24 hours, the person with a disability may designate more than one DSP.

2. No general hospital shall be required to allow more than one DSP to be present with a person with a disability at any time.

C. A general hospital may:

1. Not subject a DSP to any restrictions on visitation;

2. Require a DSP to comply with all reasonable requirements of a general hospital adopted to protect the health and safety of the person with a disability; the DSP; the staff and other patients of, or visitors to, a general hospital; and the public; and

3. Restrict a DSP's access to specified areas of and movement on the premises of a general hospital when such restrictions are determined by a general hospital to be reasonably necessary to protect the health and safety of the person with a disability; the DSP; the staff and other patients of, or visitors to, a general hospital; and the public.

D. A general hospital may request that a person with a disability provide documentation indicating status as a person with a disability.

1. If the person with a disability fails, refuses, or is unable to provide documentation requested pursuant to subsection D of this section, a general hospital may perform an objective assessment of the person to determine qualification as a person with a disability.

2. If a general hospital fails to perform an objective assessment pursuant to subdivision D 1 of this section, a general hospital may not prohibit a DSP from accompanying a person with a disability for the purpose of providing support and assistance necessary due to the specifics of the person's disability.

E. A general hospital shall

1. Establish protocols to inform patients, at the time of admission, of the right of a person with a disability who requires support and assistance necessary due to the specifics of the person's disability to be accompanied by a DSP for the purpose of providing support and assistance necessary due to the specifics of the person's disability;

2. Develop and make available to a patient or the patient's guardian, authorized representative, or care provider upon request written information regarding the right of a person with a disability who requires support and assistance necessary due to the specifics of the person's disability to be accompanied by a DSP and any policies related to that right; and

3. Make the written information described in subdivision E 2 of this section available to the public on the general hospital's website.

G. This section may not:

1. Alter the obligation of a general hospital to provide patients with effective communication support or other required services, regardless of the presence of a DSP or other reasonable accommodation, consistent with applicable federal or state law or regulations; and

2. Be interpreted to:

a. Prevent a general hospital from complying, or interfere with the ability of a general hospital to comply, with or cause a general hospital to violate any federal or state law or regulation;

b. Deem a DSP to be acting under the direction or control of a general hospital or as an agent of a general hospital; or

c. Require a general hospital to allow a DSP to perform any action or provide any support or assistance necessary due to the specifics of the person's disability when a general hospital reasonably determines that the performance of the action or provision would be:

(1) Medically or therapeutically contraindicated; or

(2) A threat to the health and safety of the person with a disability, the DSP, or the staff or other patients of, or visitors to, a general hospital.

History

• Statutory Authority: §§ 32.1-12, 32.1-127, and 32.1-137.08 of the Code of Virginia.

12VAC5-410-237 Discharge planning

A. A general hospital shall provide each patient admitted as an inpatient or the patient's legal guardian the opportunity to designate:

1. An individual who will care for or assist the patient in the patient's residence following discharge from the general hospital; and

2. To whom the general hospital shall provide information regarding the patient's discharge plan and any follow-up care, treatment, and services that the patient may require.

B. Upon admission, a general hospital shall record in the patient's medical record:

1. The name of the individual designated by the patient;

2. The relationship between the patient and the person; and

3. The person's telephone number and address.

C. If the patient fails or refuses to designate an individual to receive information regarding the patient's discharge plan and any follow-up care, treatment, and services, a general hospital shall record the patient's failure or refusal in the patient's medical record.

D. A patient may change the designated individual at any time prior to the patient's release, and the general hospital shall record the changes, including the information referenced in subsection B of this section, in the patient's medical record within 24 hours of such a change.

E. Prior to discharging a patient who has designated an individual pursuant to subsection A or D of this section, the general hospital shall:

1. Notify the designated individual of the patient's discharge;

2. Provide the designated individual with a copy of the patient's discharge plan and instructions and information regarding any follow-up care, treatment, or services that the designated individual will provide; and

3. Consult with the designated individual regarding the designated individual's ability to provide the care, treatment, or services.

F. The discharge plan prescribed in subdivision E 2 of this section shall include:

1. The name and contact information of the designated individual;

2. A description of follow-up care, treatment, and services that the patient requires; and

3. Information, including contact information, about any health care, long-term care, or other community-based services and supports necessary for the implementation of the patient's discharge plan.

G. A general hospital shall include a copy of the discharge plan and any instructions or information provided to the designated individual in the patient's medical record.

H. A general hospital shall provide each individual designated pursuant to subsection A or D of this section the opportunity for a demonstration of specific follow-up care tasks that the designated individual will provide to the patient in accordance with the patient's discharge plan prior to the patient's discharge, including opportunity for the designated individual to ask questions regarding the performance of follow-up care tasks in a culturally competent manner and in the designated individual's native language.

I. A general hospital shall establish protocols to ensure that any patient scheduled to receive an elective surgical procedure for which the patient can reasonably be expected to require outpatient physical therapy as a follow-up treatment after discharge is informed that the patient:

1. Is expected to require outpatient physical therapy as a follow-up treatment; and

2. Will be required to select a physical therapy provider prior to being discharged from a general hospital.

History

• Statutory Authority: §§ 32.1-12, 32.1-127, and 32.1-137.03 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 42, Issue 18, eff. June 4, 2026.

12VAC5-410-240 Anesthesia service

A. Each hospital which provides surgical or obstetrical services shall have an organized anesthesia department/service.

The anesthesia department/service shall be directed by a physician member of the medical staff.

B. The anesthesia department/service shall be organized under written policies and procedures regarding staff privileges, the administration of anesthetics, the maintenance of safety controls and qualifications, and supervision of anesthetists and trainees.

C. Policies shall include provisions in addition to the above, for at least:

1. Pre-anesthesia evaluation by a medical staff member;

2. Safety of the patient during the anesthesia period;

3. Review of patient's condition prior to induction of anesthesia and post anesthetic evaluation; and

4. Recording of all events related to each phase of anesthesia care.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.8, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-250 Sterile supply service

A. Each hospital shall operate a sterile supply service or provide for the processing, sterilizing, storing, and dispensing of clean and sterile supplies and equipment.

B. Facilities shall be provided for the cleaning, preparation, sterilizing, aeration, storage and dispensing of supplies and equipment for patient care.

C. Areas for the processing of clean and soiled supplies and equipment shall be separated by physical barriers.

D. Written procedures shall be established subject to the approval of the Infection Control Committee for all sterile supply service functions including:

1. Procedures for all sterilizing and for the disposal of wastes and contaminated supplies; and

2. Procedures for the safety of personnel and patients.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.9, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-260 Dietary service

A. Each hospital shall maintain a dietary service directed by a full-time person, qualified as allowed in 12VAC5-421.

B. Each hospital shall have at least one dietitian, meeting the criteria of § 54.1-2731 of the Code of Virginia, employed on either a full-time, part-time or on a consultative basis, to direct nutritional aspects of patient care and to advise on food preparation and service.

C. Space, equipment and supplies shall be provided for the efficient, safe and sanitary receiving, storage, refrigeration, preparation and serving of food.

D. The hospital food service operation shall comply with applicable standards in 12VAC5-421.

E. A diet manual approved by the medical staff shall be maintained by the dietary service. Diets served to patients shall comply with the principles set forth in the diet manual.

F. All patient diets, including therapeutic diets, shall be ordered in writing by a practitioner, or by a dietitian as authorized by the medical staff, responsible for the care of the patient.

1. Hospitals and their medical staffs may grant privileges to dietitians meeting the criteria of § 54.1-2731 of the Code of Virginia to order patient diets, including therapeutic diets, and to order laboratory tests to help determine appropriate diets for the patient.

2. Therapeutic diets include the provision of enteral and parenteral nutrition.

G. Pertinent observations and information relative to the special diets and to dietetic treatment shall be recorded in the patient's medical record.

H. A hospital contracting for food service shall require, as part of the contract, that the contractor comply with the provisions of this section.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.10, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 11, Issue 16, eff. June 1, 1995; Volume 22, Issue 8, eff. January 25, 2006; Volume 32, Issue 7, eff. January 14, 2016.

12VAC5-410-270 Disaster and mass casualty programs

A. Each hospital shall develop and maintain a written disaster plan that includes provisions for complete evacuation of the facility and care of mass casualties.

B. The plan shall provide for widespread disasters as well as for disaster occurring within the local community and hospital facility.

C. The disaster plan shall be rehearsed at least twice a year preferably as part of a coordinated drill in which other community emergency service agencies participate. Written reports and evaluation of all drills shall be maintained for at least two years.

D. A copy of the plan and any revision thereto shall be made available to the OLC upon request.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.11, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 22, Issue 8, eff. January 25, 2006; Volume 23, Issue 10, eff. March 1, 2007.

12VAC5-410-280 Emergency service

A. Hospitals with an emergency department or service shall have 24-hour staff coverage and shall have at least one physician who is primarily responsible for the emergency department on duty and physically present at all times. Hospitals without emergency service shall have written policies governing the handling of emergencies.

B. No fewer than one registered nurse shall be assigned to the emergency service on each shift. Such assignment need not be exclusive of other duties, but must have priority over all other assignments.

C. Those hospitals that provide ambulance services shall comply with Article 2.1 (§ 32.1-111.1 et seq.) of Chapter 4 of Title 32.1 of the Code of Virginia and 12VAC5-31.

D. The hospital shall provide equipment, drugs, supplies, and ancillary services commensurate with the scope of anticipated needs, including radiology and laboratory services and facilities for handling and administering blood and blood products. Emergency drugs and equipment shall remain accessible in the emergency department at all times.

E. A current roster of medical staff members on emergency call, including alternates and medical specialists or consultants, shall be posted in the emergency department.

F. Hospitals shall make special training available, as required, for emergency department personnel.

G. Toxicology reference material and poison antidote information shall be available along with telephone numbers of the nearest poison control centers.

H. Each emergency department shall post notice of the existence of a human trafficking hotline to alert possible witnesses or victims of human trafficking to the availability of a means to gain assistance or report crimes. This notice shall be in a place readily visible and accessible to the public, such as the patient admitting area or public or patient restrooms. The notice shall meet the requirements of § 40.1-11.3 C of the Code of Virginia.

I. Every hospital with an emergency department shall establish a security plan for each emergency department that:

1. Is developed using standards established in the Healthcare Security Industry Guidelines, 13th Edition (International Association for Healthcare Security and Safety);

2. Is based on:

a. The results of a security risk assessment of each emergency department location of the hospital; and

b. Risks for the emergency department identified in consultation with the emergency department medical director and nurse director, including:

(1) Trauma level designation;

(2) Overall patient volume;

(3) Volume of psychiatric and forensic patients;

(4) Incidents of violence against staff;

(5) Level of injuries sustained from such violence; and

(6) Prevalence of crime in the community;

3. Includes the presence of one or more off-duty law-enforcement officers or trained security personnel in the emergency department at all times, except as provided in subsection L of this section, and as indicated to be necessary and appropriate by the security risk assessment; and

4. Outlines training requirements for security personnel in:

a. The potential use of and response to weapons;

b. Defensive tactics;

c. De-escalation techniques;

d. Appropriate physical restraint and seclusion techniques;

e. Crisis intervention;

f. Trauma-informed approaches; and

g. Safely addressing situations involving patients, family members, or other persons who pose a risk of harm to themselves or others due to mental illness or substance abuse or who are experiencing a mental health crisis.

J. The hospital may:

1. Accept from the hospital's security personnel the satisfactory completion of the Department of Criminal Justice Services minimum training standards for auxiliary police officers as required by § 15.2-1731 of the Code of Virginia in lieu of the training prescribed by subdivision I 4 of this section; and

2. Request to use industry standards other than those specified in subdivision I 1 of this section by submitting a written request for alternative industry standards to the OLC that:

a. Specifies the title, edition if applicable, and author of the alternative industry standards; and

b. Provides an explanation of how the alternative industry standards are substantially similar to those specified in subdivision I 1 of this section.

K. Every hospital with an emergency department shall update the hospital's security plan, including its security risk assessment, for each emergency department location of the hospital as often as necessary but not to exceed two years.

L. The commissioner shall provide a waiver from the requirement that at least one off-duty law-enforcement officer or trained security personnel be present at all times in the emergency department if the hospital demonstrates that a different level of security is necessary and appropriate for any of the hospital's emergency departments based upon findings in the security risk assessment.

1. A hospital shall submit a written request for a waiver pursuant to this subsection and shall:

a. Specify the location of the emergency department for which the waiver is requested;

b. Provide a dated copy of the security risk assessment performed for the specified emergency department that has been reviewed and approved by the governing body or the governing body's designee; and

c. Indicate the requested duration of the waiver.

2. The commissioner shall specify in any waiver granted pursuant to this subsection:

a. The location of the emergency department for which the waiver is granted;

b. The level of security to be provided at the specified emergency department location;

c. The effective date of the waiver; and

d. The duration of the waiver, which may not exceed two years from the date of issuance.

3. A hospital granted a waiver pursuant to this subsection shall:

a. Notify the commissioner in writing no less than 30 calendar days after its security risk assessment changes if such change impacts when or how many off-duty law-enforcement officers or trained security personnel should be present at the emergency department for which a waiver was granted;

b. Provide a dated copy of the changed security risk assessment performed for the specified emergency department that has been reviewed and approved by the governing body or the governing body's designee; and

c. Indicate whether the hospital is:

(1) Requesting a modification to its existing waiver; or

(2) Surrendering its existing waiver.

4. The commissioner may request additional information from the hospital in evaluating the requested waiver.

5. The commissioner may modify or rescind a waiver granted pursuant to this subsection if:

a. Additional information becomes known that alters the basis for the original decision, including if the security risk assessment changes regarding how many off-duty law-enforcement officers or trained security personnel should be present at the emergency department for which a waiver was granted; or

b. Results of the waiver jeopardize the health or safety of patients, employees, contractors, or the public.

6. Pursuant to the Virginia Freedom of Information Act (§ 2.2-3700 et seq. of the Code of Virginia), the Virginia Department of Health:

a. May not release to the public information that a hospital discloses pursuant to this subsection, the waiver request, or the response to the waiver to the extent those records are exempt from disclosure; and

b. Shall notify the Secretary of Public Safety and Homeland Security of any request for records specified in subdivision L 6 a of this section, the person making such request, and the Virginia Department of Health's response to the request.

M. Each hospital with an emergency department shall establish a protocol for the treatment and discharge of individuals experiencing a substance use-related emergency, which shall include provisions for:

1. Appropriate screening and assessment of individuals experiencing substance use-related emergencies to identify medical interventions necessary for the treatment of the individual in the emergency department; and

2. Recommendations for follow-up care following discharge for any patient identified as having a substance use disorder, depression, or mental health disorder, as appropriate. For patients who have been treated for substance use-related emergencies, including opioid overdose, or other high-risk patients, recommendations may include:

a. The dispensing of naloxone or other opioid antagonist used for overdose reversal pursuant to § 54.1-3408 X of the Code of Virginia at discharge; or

b. Issuance of a prescription for and information about accessing naloxone or other opioid antagonist used for overdose reversal, including information about accessing naloxone or other opioid antagonist used for overdose reversal at a community pharmacy, including an outpatient pharmacy operated by the hospital, or through a community organization or pharmacy that may dispense naloxone or other opioid antagonist used for overdose reversal without a prescription pursuant to a statewide standing order.

The protocol may also provide for referrals of individuals experiencing a substance use-related emergency to peer recovery specialists and community-based providers of behavioral health services or to providers of pharmacotherapy for the treatment of drug or alcohol dependence or mental health diagnoses.

N. Beginning January 1, 2026, every hospital with an emergency department, if conducting a urine drug screening to assist in diagnosing a patient's condition, shall include testing for fentanyl in the urine drug screening.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.12, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 22, Issue 8, eff. January 25, 2006; Volume 35, Issue 4, eff. November 14, 2018; Volume 36, Issue 23, eff. August 6, 2020; Volume 40, Issue 22, eff. July 17, 2024; Volume 41, Issue 17, eff. May 22, 2025; Volume 42, Issue 1, eff. September 24, 2025; Volume 42, Issue 5, eff. November 19, 2025.

12VAC5-410-290 Laboratory service; general

A. The director of laboratory service shall be a physician member of the medical staff. If the physician director of laboratory service is not a pathologist, a pathologist shall be retained on a consultant basis.

When the pathologist provides services only on a consultative basis, these services shall be provided at least on a monthly basis. A written evaluation report with recommendations to the medical staff and administration shall be provided by the consultant pathologist on a monthly basis.

B. Laboratories shall have adequate space, equipment, and supplies and shall be operated according to 42 CFR Part 493.

C. Provisions shall be made to assure continuous availability of emergency laboratory services.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.13, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 22, Issue 8, eff. January 25, 2006.

12VAC5-410-300 Clinical laboratory services

Examination in the fields of hematology, chemistry, microbiology, seroimmunology, clinical microscopy and other services necessary to meet patient care needs shall be provided directly or shall be provided through a contractual arrangement with a reference laboratory.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.14, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-310 Tissue pathology

A. Tissue pathology services shall be provided either by the hospital or pursuant to contractual arrangements with a laboratory. In the latter instance, written policies and procedures shall be established governing prompt transportation of specimens and submission of reports.

B. In accordance with medical staff bylaws, surgically removed tissues shall be examined by a pathologist and findings shall be included in the patient's medical record.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.15, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-320 Quality control

There shall be a quality control program designed to ensure reliability of the laboratory data and shall include provisions for no less than:

1. Frequency and method of work performance evaluation;

2. Frequency and method of performance testing of instruments and equipment;

3. A preventive and corrective maintenance program;

4. Participation in appropriate external proficiency testing programs for the services provided.

5. Maintenance for at least two years of records documenting quality control activities.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.16, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-330 Autopsy service

An autopsy service shall be provided either directly by the hospital or written contractual agreement with another institution.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.17, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 11, Issue 16, eff. June 1, 1995.

12VAC5-410-340 Blood banks and transfusion services

A. If the hospital provides facilities for the procurement, extraction and collection of blood and blood products, written policies and procedures for all phases of operation of blood banks and transfusion services shall be established and periodically revised to comply with 42 CFR Part 493, 42 CFR 482.27 and 21 CFR Part 606.

B. Each hospital shall provide appropriate facilities and equipment for the storage and administration of whole blood and blood products.

C. For emergency situations, the hospital shall:

1. Make arrangements by which blood can be quickly obtained from community blood sources, or maintain an up-to-date list of available donors, as well as provide the equipment and personnel and obtain blood from the donor; or

2. Maintain a minimum supply of O negative blood, if the hospital provides obstetrical services.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.18, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 11, Issue 16, eff. June 1, 1995; Volume 22, Issue 8, eff. January 25, 2006.

12VAC5-410-350 Isolation of special microorganisms

When a hospital diagnostic laboratory isolates from clinical, pathological or environmental specimens, any one of the special micro-organisms listed in 12VAC5-90-80, it shall be reported as required pursuant to 12VAC5-90.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.19, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 22, Issue 8, eff. January 25, 2006.

12VAC5-410-360 Nuclear medicine

Every hospital that maintains a nuclear medicine service within the institution or through contractual arrangements shall ensure that it is under the medical supervision of a physician who is a designated authorized user of isotopes licensed by the Nuclear Regulatory Commission or the Office of Radiologic Health of the Department of Health as required by 12VAC5-480.

1. There shall be quality control procedures governing nuclear medicine services to ensure diagnostic reliability and therapeutic effectiveness.

2. Records of diagnostic or therapeutic services shall be incorporated in the patient's medical record.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.20, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 22, Issue 8, eff. January 25, 2006.

12VAC5-410-370 Medical records

A. The medical record department shall be staffed and equipped to facilitate the accurate processing, checking, indexing, filing, and retrieval of all medical records.

B. A medical record shall be established and maintained for every person treated on an inpatient, outpatient (ambulatory), or emergency basis in any unit of the hospital. The record shall be available to all other units.

A separate medical record shall be maintained for each newborn infant. Entered on the chart of the newborn shall be notes of gestational history, including any pathology and information regarding complications of delivery and mother's medication during labor and delivery.

C. Written policies and procedures shall be established regarding content and completion of medical records.

D. Entries in the medical record shall be made by the responsible person in accordance with hospital policies and procedures.

E. Provisions shall be made for the safe storage of medical records and the accurate and legible reproductions of medical records according to § 32.1-127.1:03 of the Code of Virginia and the Health Insurance Portability and Accountability Act (Pub. L. No. 104-191).

F. All medical records, either original or accurate reproductions, shall be preserved for a minimum of five years following discharge of the patient.

1. Records of minors shall be kept for at least five years after such minor has reached 18 years of age.

2. Birth and death information shall be retained for 10 years in accordance with § 32.1-274 of the Code of Virginia.

3. Record of abortions and proper information for the issuance of a fetal death certificate shall be furnished to the Virginia Department of Health Office of Vital Records as required by law.

G. A general hospital that makes health records, as defined in § 32.1-127.1:03 of the Code of Virginia, of patients who are minors available to patients through a secure website shall make the health records available to the patient's parent or guardian through the secure website, unless the general hospital cannot make the health record available:

1. In a manner that prevents disclosure of information, the disclosure of which has been denied pursuant to § 32.1-127.1:03 F of the Code of Virginia; or

2. Because the consent required in accordance with § 54.1-2969 E of the Code of Virginia has not been provided.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.21, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 22, Issue 8, eff. January 25, 2006; Volume 42, Issue 18, eff. June 4, 2026.

12VAC5-410-380 Nursing service

A. Each hospital shall have an organized nursing department. A registered nurse qualified on the basis of education, experience, and clinical ability shall be responsible for the direction of nursing care provided the patients.

B. The number and type of nursing personnel on all shifts shall be based upon the needs of the patients and the capabilities of the nursing staff assigned to the patient care unit. All registered nurses and licensed practical nurses shall hold a current license issued by the Virginia Board of Nursing or a current multistate licensure privilege to practice nursing in Virginia.

C. All nursing services shall be directly provided by an appropriately qualified registered nurse or licensed practical nurse, except for those nursing tasks that may be delegated by a registered nurse according to 18VAC90-19-240 through 18VAC90-19-280 with a plan developed and implemented by the hospital.

D. Nursing personnel shall be assigned to patient care units in a manner that minimizes the risk of cross infection and accidental contamination.

E. Each hospital shall quarterly report to the department no later than 30 calendar days after January 1, April 1, July 1, and October 1:

1. The total number of certified sexual assault nurse examiners employed by the hospital; and

2. The location, including street address, and contact information for each location at which the certified sexual assault nurse examiners provide services.

Each hospital shall report the information required by this subsection to the Virginia Department of Health Office of Family Health Services.

History

• Statutory Authority: §§ 32.1-12, 32.1-23.2, and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.22, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 11, Issue 16, eff. June 1, 1995; Volume 22, Issue 8, eff. January 25, 2006; Volume 42, Issue 18, eff. June 4, 2026.

12VAC5-410-390 Pharmaceutical service

A. Each hospital shall provide pharmaceutical services under the direction of a pharmacist licensed by the Virginia Board of Pharmacy.

B. There shall be evidence of a current pharmacy license pursuant to Chapter 33 (§ 54.1-3300 et seq.) of Title 54.1 of the Code of Virginia and 18VAC110-20.

C. Each hospital shall obtain a criminal history record check pursuant to § 32.1-126.02 of the Code of Virginia on any compensated employee, not licensed by the Board of Pharmacy, whose job duties provide access to controlled substances with the hospital pharmacy.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.23, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 19, Issue 1, eff. November 1, 2002; Volume 22, Issue 8, eff. January 25, 2006.

12VAC5-410-400 Radiology service

A. Each hospital shall maintain radiology services which are under the medical supervision of a physician who meets the qualifications of the medical staff bylaws.

B. Hospitals maintaining radiotherapy services shall provide for their safe and effective operation under a director qualified by training and experience in therapeutic radiology.

C. Sufficient technical personnel shall be available, consistent with the scope of services provided.

D. Space and equipment shall be provided for radiographic and fluoroscopic X-ray services including facilities for processing and storage of radiographic films and records.

E. Reports of radiological interpretations, consultations and therapy shall be part of the patient's medical record.

F. Reports shall be preserved in accordance with 12VAC5-410-370 H.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.24, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-410 Social service

A. Every hospital shall have a plan for the provision of social services to the patient and the patient's family.

B. An employee of the hospital with knowledge of community agencies and other social service resources shall be designated to assume responsibility for said service.

C. Appropriate records shall be maintained.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.25, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-420 Surgical service

A. The surgical department/service shall have a defined organization and shall be governed by written policies and procedures.

B. The surgical department/service shall be under the medical supervision of a physician who meets the requirements of the medical staff bylaws.

C. The operating suite shall be:

1. Under the supervision of a registered professional nurse.

2. Designed to include operating and recovery rooms, proper scrubbing, sterilizing and dressing room facilities, and storage for anesthetic agents and shall be equipped as required by the scope and complexity of the services.

3. Provided with prominently posted safety policies and procedures.

D. A roster of current surgical privileges of every surgical staff member shall be maintained on file in the operating suite.

E. An operating room register shall be maintained, which shall include, as a minimum:

1. Patient's name and hospital number;

2. Pre-operative and post-operative diagnosis;

3. Complications, if any;

4. Name of surgeon, first assistant, anesthesiologist or anesthetist, scrub nurse, and circulating nurse;

5. Operation performed; and

6. Type of anesthesia.

F. Every hospital where surgical procedures are performed shall adopt a policy requiring the use of a smoke evacuation system for all planned surgical procedures that are likely to generate surgical smoke.

G. Policies and procedures governing infection control and reporting techniques shall be established in accordance with 12VAC5-410-490.

H. The patient's medical chart shall be available in the surgical suite at time of surgery and shall contain no less than the following information:

1. A medical history and physical examination;

2. Evidence of appropriate informed consent; and

3. A pre-operative diagnosis.

I. An accurate and complete description of operative procedure shall be recorded by the operating surgeon within 48 hours following completion of surgery and made part of the patient's clinical record.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.26, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 11, Issue 16, eff. June 1, 1995; Volume 42, Issue 1, eff. September 24, 2025.

Article 3 Special Services

12VAC5-410-430 Applicability

Article 3 Special Services

If a hospital provides any of the services in this article, the requirements of the specific service shall apply.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.27, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-440 Obstetric and newborn services general requirements

A. Hospitals with licensed obstetric and newborn services in operation prior to August 10, 1995, or revisions to thereof shall comply with all of the requirements of this section with the exception of specified sections of 12VAC5-410-442. Hospitals that establish and organize obstetric and newborn services after August 10, 1995, shall comply with all requirements of this section and 12VAC5-410-441 through 12VAC5-410-447 before licensure approval is granted.

B. A hospital with organized obstetric and newborn services shall comply with the following general requirements:

1. The governing body of the hospital or the chief executive officer shall appoint an administrative manager for the obstetric and newborn services. The administrative manager may serve as an administrator of another hospital service but must be available to the obstetric and newborn services. The chief executive officer shall designate, in writing, an individual to act in the administrative manager's behalf during a temporary absence of the administrative manager.

2. The hospital is responsible for the development, periodic review and revision of a service management plan. The plan must include provisions to assure that the hospital complies with all state and federal regulations and guidelines applicable to obstetric and newborn care as well as the policies and procedures for obstetric and newborn care adopted by the hospital's governing body and medical staff. The plan is to be developed and maintained as follows:

a. The plan shall be developed in cooperation with the medical directors and nursing staffs assigned to each of the services.

b. The plan shall include the protocol, required by § 32.1-127 of the Code of Virginia, for the admission or transfer of any pregnant woman who presents in labor.

c. The plan shall be the responsibility of the administrative manager who is to assure that the plan is developed, that it complies with state and federal requirements and the hospital's policies and procedures, and that it is periodically reviewed and revised.

d. A copy of the plan shall be readily available at each nursing station within the obstetric and newborn services for staff reference.

e. A copy of the plan shall be made available, upon request, to the licensing inspector for review.

3. The hospital shall provide the following services in support of the obstetric and newborn services units:

a. Clinical laboratory services and blood bank services shall be available in the hospital on a 24-hour basis. Laboratory and blood bank personnel shall be available on-site or on-call on a 24-hour basis. The blood bank shall have group O Rh negative blood available at all times and be able to provide correctly matched blood in 45 minutes from request. The hospital's laboratory and blood bank personnel must be capable of performing the following tests with less than 1.0 ml of blood within one hour of request or less if specified:

(1) Blood group and Rh type determination/cross matching

(2) Arterial blood gases within 20 minutes

(3) Blood glucose within 20 minutes

(4) Complete blood count

(5) Total protein

(6) Total bilirubin

(7) Direct Coombs test

(8) Electrolytes

(9) Blood urea nitrogen

(10) Clotting profile (may require more than one cc of blood).

b. Portable radiological services for basic radiologic studies in each labor room, delivery room, and nursery shall be available on call on a 24-hour basis.

c. In addition to the requirements specified in 12VAC5-410-240 anesthesia service personnel shall be available on-site or on-call to begin anesthesia within 30 minutes of notification.

C. Beginning July 1, 2012, hospitals providing maternity care shall offer to obtain a sample of blood from an infant born at the hospital and provide that sample to the mother of the infant.

History

• Statutory Authority: § 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.28, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 11, Issue 16, eff. June 1, 1995; Volume 11, Issue 21, eff. August 10, 1995; Volume 21, Issue 6, eff. February 14, 2005; Volume 28, Issue 2, eff. November 1, 2011.

12VAC5-410-441 Obstetric service requirements; medical direction; physician consultation and coverage; nurse staffing and coverage; policies and procedures

A. The governing body shall appoint a physician as medical director of the organized obstetric service who meets the qualifications specified in the medical staff bylaws.

1. If the medical director is not a board certified obstetrician or board eligible in obstetrics, the hospital shall have a written agreement with one or more board-certified or board-eligible obstetricians to provide consultation on a 24-hour basis. Consultation may be by telephone.

2. The duties and responsibilities of the medical director of obstetric services shall include:

a. The general supervision of the quality of care provided patients admitted to the service;

b. The establishment of criteria for admission to the service;

c. The adherence to standards of professional practices and policies and procedures adopted by the medical staff and governing body;

d. The development of recommendations to the medical staff on standards of professional practice and staff privileges;

e. The identification of clinical conditions and medical or surgical procedures that require physician consultation; and

f. Arranging conferences, at least quarterly, to review obstetrical surgical procedures, complications, and infant and maternal mortality and morbidity. Infant mortality and morbidity shall be discussed jointly between the obstetric and newborn service staffs.

B. A physician with obstetrical privileges capable of arriving on site within 30 minutes of notification shall be on a 24-hour on-call duty roster.

C. A physician with obstetrical privileges shall be accessible for patient treatment within 10 minutes during the administration of an oxytocic agent to an antepartum patient.

D. A physician or a certified nurse-midwife, under the supervision of a physician with obstetrical privileges, shall be in attendance for each delivery. Physician supervision of the nurse-midwife shall be in compliance with the regulations of the Boards of Nursing and Medicine.

E. A physician shall be in attendance during all high-risk deliveries. High-risk deliveries shall be defined by the obstetric service medical staff.

F. A physician or a nurse skilled in neonatal cardiopulmonary resuscitation (CPR) shall be available in the hospital at all times.

G. A current roster of physicians, with a delineation of their obstetrical, newborn, pediatric, medical, and surgical staff privileges, shall be posted at each nurses' station in the obstetric suite and in the emergency room.

H. A copy of the 24-hour on-call duty schedule, including the list of on-call consulting physicians, shall be posted at each nurses' station in the obstetric suite and in the emergency room.

I. An occupied unit of the obstetrics service shall be supervised by a registered nurse 24 hours a day.

J. If the postpartum unit is organized as a separate nursing unit, staffing shall be based on a formula of one nursing personnel for every six to eight obstetric patients. Staffing shall include at least one registered nurse for the unit for each duty shift.

K. If the postpartum and general care newborn units are organized as combined rooming-in or modified rooming-in units, staffing shall be based on a formula of one nursing personnel for every four mother-baby units. The rooming-in units shall be staffed at all times with no less than two nursing personnel each shift. At least one of the two nursing personnel on each shift shall be a registered nurse.

L. For the purposes of this section:

1. "Birth" includes both vaginal birth and cesarean section.

2. "Doula" means a person who provides physical, emotional, and informational support to a pregnant person before, during, and after pregnancy.

3. "Postpartum process" means the biologic process that happens to both the newborn and birthing person after delivery due to endogenous hormone systems.

M. A health care facility that provides services related to labor and childbirth shall develop policies that:

1. Allow every birthing person to have a companion or doula with the person during birth in addition to a partner or spouse when a partner or spouse is permitted to be present;

2. At the discretion of the treating physician, allow every birthing person to have a companion or doula with the person during birth when a partner or spouse is not permitted to be present;

3. Prioritize newborns bonding with the newborn's families in order to facilitate the postpartum process;

4. Will not exclude from care a person giving birth, or interrupt the process of birth without the informed consent of the birthing person, unless at the discretion of the treating physician;

5. Detail the facility's process related to receiving a pregnant person's patient information from any provider regulated under Title 54.1 of the Code of Virginia who has provided care for the pregnant person;

6. Establish processes to transfer and receive pregnant persons across levels of care of licensed facilities within the facility's capacity and capability; and

7. Establish a process to receive individuals who are pregnant, giving birth, or in the postpartum process from locations other than licensed facilities, including a process to receive verbal and written information from individuals with relevant information, including family members, doulas, or a health care provider regulated under Title 54.1 of the Code of Virginia.

N. A registered nurse shall be in attendance at all deliveries. The nurse shall be available on site to monitor the mother's general condition and that of the fetus during labor, at least one hour after delivery, and longer if complications occur.

O. Nurse staffing of the labor and delivery unit shall be scheduled to ensure that the total number of nursing personnel available on each shift is equal to one-half of the average number of deliveries in the hospital during a 24-hour period.

P. At least one of the personnel assigned to each shift on the obstetrics unit shall be a registered nurse. At no time when the unit is occupied shall the nursing staff on any shift be less than two staff members.

Q. Patients placed under analgesia or anesthesia during labor or delivery shall be under continuous observation by a registered nurse or a licensed practical nurse for at least one hour after delivery.

R. To ensure adequate nursing staff for labor, delivery, and postpartum units during busy or crisis periods, duty schedules shall be developed in accordance with the following nurse-to-patient ratios:

1. 1:1 to 2 Antepartum testing;

2. 1:2 Laboring patients;

3. 1:1 Patients in second stage of labor;

4. 1:1 Ill patients with complications;

5. 1:2 Oxytocin induction or augmentation of labor;

6. 1:2 Coverage of epidural anesthesia;

7. 1:1 Circulation for cesarean delivery;

8. 1:6 to 8 Antepartum/postpartum patients without complications;

9. 1:2 Postoperative recovery;

10. 1:3 Patients with complications, but in stable condition; and

11. 1:4 Mother-newborn care.

S. Student nurses, licensed practical nurses, and nursing aides who assist in the nursing care of obstetric patients shall be under the supervision of a registered nurse.

T. At least one registered nurse trained in obstetric and neonatal care shall be assigned to the care of mothers and infants at all times.

U. At least one member of the nursing staff on each shift who is skilled in cardiopulmonary resuscitation of the newborn must be immediately available to the delivery suite.

V. All nursing personnel assigned to the obstetric service shall have orientation to the obstetrical unit.

W. The governing body shall adopt written policies and procedures for the management of obstetric patients approved by the medical and nursing staff assigned to the service.

1. The policies and procedures shall include the following:

a. Criteria for the identification and referral of high-risk obstetric patients;

b. The types of birthing alternatives, if offered by the hospital;

c. The monitoring of patients during antepartum, labor, delivery, recovery, and postpartum periods with or without the use of electronic equipment;

d. The use of equipment and personnel required for high-risk deliveries, including multiple births;

e. The presence of family members or chosen companions during labor, delivery, recovery, and postpartum periods;

f. The reporting to the Virginia Department of Health of all congenital defects;

g. The care of patients during labor and delivery to include the administration of Rh O(D) immunoglobulin to Rh negative mothers who have met eligibility criteria. Administration of RH O(D) immunoglobulin shall be documented in the patient's medical record;

h. The provision of family planning information to each obstetric patient at time of discharge in accordance with § 32.1-134 of the Code of Virginia;

i. The use of specially trained paramedical and nursing personnel by the obstetrics and newborn service units;

j. A protocol for hospital personnel to use to assist them in obtaining public health, nutrition, genetic, and social services for patients who need those services;

k. The use of anesthesia with obstetric patients;

l. The use of radiological and electronic services, including safety precautions, for obstetric patients;

m. The management of mothers who utilize breast milk with their newborns. Breast milk shall be collected in aseptic containers, dated, stored under refrigeration, and consumed or disposed of within 24 to 48 hours of collection if the breast milk has not been frozen. This policy pertains to breast milk collected while in the hospital or at home for hospital use;

n. Staff capability to perform cesarean sections within 30 minutes of notice;

o. Emergency resuscitation procedures for mothers and infants;

p. The treatment of volume shock in mothers;

q. Training of hospital staff in discharge planning for identified substance abusing, postpartum women and their infants;

r. Written discharge planning for identified substance abusing, postpartum women and their infants. The discharge plans shall include appropriate referral sources available in the community or locality for mother and infants such as:

(1) Substance abuse treatment services; and

(2) Comprehensive early intervention services for infants and toddlers with disabilities and their families pursuant to Part H of the Individuals with Disabilities Education Act, 20 USC § 1471 et seq.

The discharge planning process shall be coordinated by a health care professional and shall include, to the extent possible, (i) the father of the infant and (ii) any family members who may participate in the follow-up care of the mother or infant. The discharge plan shall be discussed with the mother and documented in the medical record; and

s. The provision of information pursuant to § 32.1-134.01 of the Code of Virginia about the incidence of postpartum blues, perinatal depression, and perinatal anxiety; information to increase awareness of shaken baby syndrome and the dangers of shaking infants; and information about safe sleep environments for infants that is consistent with current information from the American Academy of Pediatrics.

2. The obstetric service shall adopt written policies and procedures for the use of the labor, delivery, and recovery rooms (LDR)/Labor, delivery, recovery and postpartum rooms (LDRP) that include the following:

a. The philosophy, goals, and objectives for the use of the LDR/LDRP rooms;

b. Criteria for patient eligibility to use the LDR/LDRP rooms;

c. Identification of high-risk conditions that disqualify patients from use of the LDR/LDRP rooms;

d. Patient care in LDR/LDRP rooms, including the following;

(1) Defining vital signs, the intervals at which they shall be taken, and requirements for documentation; and

(2) Observing, monitoring, and assessing the patient by a registered nurse, certified nurse midwife, or physician;

e. The types of analgesia and anesthesia to be used in LDR/LDRP rooms;

f. Specifications of conditions of labor or delivery requiring transfer of the patient from LDR/LDRP rooms to the delivery room;

g. Specification of conditions requiring the transfer of the mother to the postpartum unit or the newborn to the nursery;

h. Criteria for early or routine discharge of the mother and newborn;

i. The completion of medical records;

j. The presence of family members or chosen companions in the delivery room or operating room in the event that the patient is transferred to the delivery room or operating room;

k. The number of visitors allowed in the LDR/LDRP room, and their relationship to the mother; and

l. Infection control, including gowning and attire to be worn by persons in the LDR/LDRP room, upon leaving it, and upon returning.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Former 12VAC5-41-440 C 1 to 4 derived from VR 355-33-500 § 2.28, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 11, Issue 16, eff. June 1, 1995; Volume 11, Issue 21, eff. August 10, 1995; amended and adopted as 12VAC5-410-441, Virginia Register Volume 21, Issue 6, eff. February 14, 2005; amended, Virginia Register Volume 37, Issue 14, eff. April 15, 2021; Volume 42, Issue 5, eff. November 19, 2025.

12VAC5-410-442 Obstetric service design and equipment criteria

A. Renovation or construction of a hospital's obstetric unit shall be consistent with (i) section 2.2-2.10 of Part 2 of the Guidelines for Design and Construction of Hospitals, 2022 Edition (The Facility Guidelines Institute) and (ii) the Virginia Uniform Statewide Building Code (13VAC5-63).

B. Delivery rooms; labor, deliver, and recover (LDR) rooms; labor, delivery, recovery, and postpartum (LDRP) rooms; and nurseries shall be equipped to provide emergency resuscitation for mothers and infants.

C. Equipment and supplies shall be assigned for exclusive use in the obstetric and newborn units.

D. The same equipment and supplies required for the labor room and delivery room shall be available for use in the LDR/LDRP rooms during periods of labor, delivery, and recovery.

E. Sterilizing equipment shall be available in the obstetric unit or in a central sterilizing department. Flash sterilizing equipment or sterile supplies and instruments shall be provided in the obstetric unit.

F. Daily monitoring is required of the stock of necessary equipment in the LDR rooms and LDRP rooms and nursery.

G. The hospital shall provide the following equipment in the labor, delivery, and recovery rooms and, except where noted, in the LDR/LDRP rooms:

1. Labor rooms.

a. A labor or birthing bed with adjustable side rails.

b. Adjustable lighting adequate for the examination of patients.

c. An emergency signal and intercommunication system.

d. A sphygmomanometer, stethoscope, and fetoscope or doppler.

e. Fetal monitoring equipment with internal and external attachments.

f. Mechanical infusion equipment.

g. Wall-mounted oxygen and suction outlets.

h. Storage equipment.

i. Sterile equipment for emergency delivery to include at least one clamp and suction bulb.

j. Neonatal resuscitation cart.

2. Delivery rooms.

a. A delivery room table that allows variation in positions for delivery. This equipment is not required for the LDR/LDRP rooms.

b. Adequate lighting for vaginal deliveries or cesarean deliveries.

c. Sterile instruments, equipment, and supplies to include sterile uterine packs for vaginal deliveries or cesarean deliveries, episiotomies or laceration repairs, postpartum sterilizations, and cesarean hysterectomies.

d. Continuous in-wall oxygen source and suction outlets for both mother and infant.

e. Equipment for inhalation and regional anesthesia. This equipment is not required for LDR/LDRP rooms.

f. A heated, temperature-controlled infant examination and resuscitation unit.

g. An emergency call system.

h. Plastic pharyngeal airways, adult and newborn sizes.

i. Laryngoscope and endotracheal tubes, adult and newborn sizes.

j. A self-inflating bag with manometer and adult and newborn masks that can deliver 100% oxygen.

k. Separate cardiopulmonary crash carts for mothers and infants.

l. Sphygmomanometer.

m. Cardiac monitor. This equipment is not required for the LDR/LDRP rooms.

n. Gavage tubes.

o. Umbilical vessel catheterization trays. This equipment is not required for LDR/LDRP rooms.

p. Equipment that provides a source of continuous suction for aspiration of the pharynx and stomach.

q. Stethoscope.

r. Fetoscope.

s. Intravenous solutions and equipment.

t. Wall clock with a second hand.

u. Heated bassinets equipped with oxygen and transport incubator.

v. Neonatal resuscitation cart.

3. Recovery rooms.

a. Beds with side rails.

b. Adequate lighting.

c. Bedside stands, overbed tables, or fixed shelving.

d. An emergency call signal.

e. Equipment necessary for a complete physical examination.

f. Accessible oxygen and suction equipment.

History

• Statutory Authority: §§ 32.1-12, 32.1-127, and 32.1-127.001 of the Code of Virginia.
• Historical Notes: Former 12VAC5-41-440 C 5 and 6 derived from VR 355-33-500 § 2.28, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 11, Issue 16, eff. June 1, 1995; Volume 11, Issue 21, eff. August 10, 1995; amended and adopted as 12VAC5-410-442, Virginia Register Volume 21, Issue 6, eff. February 14, 2005; Volume 22, Issue 8, eff. January 25, 2006; Volume 23, Issue 10, eff. March 1, 2007; Volume 37, Issue 19, eff. June 9, 2021; Volume 42, Issue 18, eff. June 4, 2026.

12VAC5-410-443 Newborn service requirements; designation of newborn service levels, service levels

A. If a hospital intends to provide newborn services, it shall make application to the department requesting approval for a level of newborn service as specified in subsection B of this section. Application shall be made at least 60 days prior to the desired date of approval. Approval is required to be renewed annually. Newborn service level approval shall be based upon the hospital's certification and the department's verification that the hospital meets the requirements of this section for the level requested.

1. No approval for a general level newborn service designation will be granted without a Certificate of Public Need (COPN) or without documentation by the applicant that it provided general level newborn services prior to July 1, 1992, or that the provision of general level newborn services was found to be exempt from Certificate of Public Need review pursuant to § 32.1-102.11 of the Code of Virginia.

2. No approval for a newborn service level designation higher than general level will be granted without a Certificate of Public Need or without documentation by the applicant that it provided a newborn service level higher than general level prior to July 1, 1992, or that the provision of a newborn service level higher than general level was found to be exempt from Certificate of Public Need review pursuant to § 32.1-102.11 of the Code of Virginia.

B. A hospital's newborn service shall be designated as a general level, intermediate level, specialty level, or subspecialty level newborn service. The newborn service levels are designated as follows:

1. A general level newborn service shall provide care to newborns of low risk as specified within the service's medical protocol. A general level newborn nursery shall have the capability to care for newborns who weigh at least 2000 grams at birth or who have completed 34 weeks gestation. Risk assessment shall be provided to identify all high-risk neonates and ensure appropriate consultation. A general level newborn nursery shall have the equipment and staff capabilities to immediately stabilize a sick newborn prior to transporting the newborn to an appropriate higher level nursery. The equipment and staff to receive convalescing neonates from higher level nurseries shall also be provided.

2. An intermediate level newborn service shall provide care as specified within the service's medical protocol to moderately ill neonates or stable-growing low birthweight neonates who require only a weight increase to be ready for discharge. In addition to the capabilities required of the general level newborn nursery, the intermediate level nursery shall have the equipment and staff capabilities to provide controlled temperature environments for each neonate, the insertion and maintenance of umbilical arterial lines, hood oxygen to 40%, continuous monitoring of blood oxygen, and assisted ventilation of a neonate in preparation for transport utilizing a mechanical ventilator or an ambu bag.

3. A specialty level newborn service shall provide intensive care to high-risk neonates with neonatal illnesses as specified in the service's medical protocol. In addition to the capabilities required of the lower level nurseries, the specialty level nursery shall have the equipment and staff capabilities to provide the following: maintenance of central arterial umbilical catheters or peripheral arterial lines with constant pressure monitoring, insertion and maintenance of chest tubes for drainage, administration of total parenteral nutrition (TPN), the maintenance of pressor medications, the administration of surfactant and respiratory support to include the maintenance of hood oxygen, continuous positive airway pressure (CPAP), and neonatal mechanical ventilation beyond the immediate stabilization period.

4. A subspecialty level newborn service shall provide intensive care for high-risk, critically ill neonates with complex neonatal illnesses. The subspecialty level newborn service shall provide, in-house, a full range of pediatric medical and surgical subspecialists to care for critically ill neonates. The pediatric subspecialists required as members of the hospital's staff are those subspecialists required of a Subspecialty Perinatal Center as referenced within the 1993 edition of Toward Improving the Outcome of Pregnancy, March of Dimes Birth Defects Foundation, Appendix 6, Pages 114 and 115. Rarely, the availability of highly technical expertise and specialized physicians at another subspecialty center will indicate consultation and possibly transfer. The subspecialty level nursery shall have the capability to care for neonates born in its facility as well as those referred from lower level nurseries. The subspecialty level nursery shall have all of the technical capabilities required of the lower level nurseries as well as the equipment and staff capabilities to maintain a neonate on prostaglandin E1 (PgE1) and the ability to perform echocardiography evaluations.

C. The hospital shall establish a written medical protocol, approved by the governing body, that specifies all neonatal conditions routinely managed by the newborn service as well as protocols for those medical conditions which require consultation and may necessitate transfer to a higher level of newborn service.

D. Physician consultation shall occur between physicians at the birth hospital and at the referral hospital to which the newborn may be referred.

E. The physician at the birth hospital shall document in the newborn's medical record any physician's consultation and any agreement to manage the newborn at the birth hospital or to stabilize and then transfer the newborn according to the hospital's collaboration agreement. In the event of disagreement, the attending physician at the birth hospital shall be responsible for the management and care of the newborn and shall document the consultation and results of consultation in the newborn's medical record.

History

• Statutory Authority: § 32.1-127 of the Code of Virginia.
• Historical Notes: Former 12VAC5-41-440 D 1 and 2 derived from VR 355-33-500 § 2.28, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 11, Issue 16, eff. June 1, 1995; Volume 11, Issue 21, eff. August 10, 1995; amended and adopted as 12VAC5-410-443, Virginia Register Volume 21, Issue 6, eff. February 14, 2005.

12VAC5-410-444 Newborn service medical direction; physician consultation and coverage; nursing direction, nurse staffing, and coverage; policies and procedures

A. The governing body shall appoint a physician as medical director of the organized newborn service who meets the qualifications specified in the medical staff bylaws. In addition, the medical director must meet the qualifications specified for the medical direction of the highest level of newborn service provided by the hospital.

1. If a hospital offers only general level newborn services, the medical director shall be a physician qualified to provide normal newborn care, including the ability to immediately resuscitate and stabilize a sick newborn for transfer to a higher level of service.

2. If a hospital offers intermediate level newborn services, the medical director shall be a board-certified or board-eligible pediatrician with training and experience in the care of preterm neonates, including stabilization and ventilation management.

3. If a hospital offers specialty level newborn services, the medical director shall be a board-certified or board-eligible neonatologist.

4. If a hospital offers subspecialty level newborn services, the medical director shall be a board-certified or board-eligible neonatologist.

B. The duties and responsibilities of the medical directors of all levels of newborn service shall include:

1. General supervision of the quality of care provided patients admitted to the service;

2. Establishment of criteria for admission to the service;

3. Adherence of the service to standards of professional practices, policies and procedures, the medical protocol, and the hospital's collaboration agreements adopted by the medical staff and governing body applicable to the service;

4. Development of recommendations to the medical staff on standards of professional practice and staff privileges applicable to the service;

5. Identification of clinical conditions and medical and surgical procedures that require physician consultation;

6. Conducting conferences, at least quarterly, to review routine and emergency surgical procedures, complications, and infant and maternal mortality and morbidity. Infant mortality and morbidity shall be discussed with the obstetric service staff; and

7. Active participation in the service's quality assurance program.

C. The hospital shall provide the following physician consultation and coverage in the general level newborn nursery service and all higher level nursery services unless unique requirements are specifically imposed for the higher level nursery services:

1. A physician with pediatric privileges capable of arriving on site within 30 minutes of notification shall be on the 24-hour on-call duty roster. If a physician is not available, a certified nurse midwife, licensed certified midwife, or pediatric nurse practitioner may be on the 24-hour on-call duty roster for nursery care. In order to be on the 24-hour on-call duty roster, such health care providers shall have pediatric privileges and a neonatal resuscitation certification from the American Academy of Pediatrics, including endotracheal intubation training. Such health care providers shall be subject to the same requirement that applies to physicians regarding the capability of arriving on site within 30 minutes of notification. A physician may provide consultation via telehealth, including audio-only consultation, when a certified nurse midwife, licensed certified midwife, or pediatric nurse practitioner is providing coverage for the 24-hour on-call duty roster and a physician is incapable of arriving on site within 30 minutes of notification.

2. A physician or nurse skilled in neonatal cardiopulmonary resuscitation (CPR) shall be available in the hospital at all times.

3. A current roster of physicians, with a delineation of their newborn, pediatric, medical, and surgical privileges shall be posted at each nurses' station in the newborn service unit.

4. A copy of the 24-hour on-call duty schedule, including a list of on-call consulting physicians, shall be posted at each nurses' station in the newborn service unit.

5. If the medical director is not a board-certified or board-eligible pediatrician, the hospital shall have a written agreement with one or more board-certified or board-eligible pediatricians to be available to provide consultation on a 24-hour basis. Consultation may be by telephone.

6. If a hospital does not have a neonatologist on staff available on a 24-hour basis, it shall have a written agreement with another hospital to provide consultation, at least by telephone, on a 24-hour basis, by a board-certified or board-eligible neonatologist. The consultant shall be available to advise on the development of a protocol for the care and transport of sick newborns.

D. The physician consultation and coverage for the intermediate level newborn nursery service shall be the same as the general level newborn service with the following exceptions:

1. Subdivision C 1 of this section shall not apply.

2. Physician coverage shall be provided on a 24-hour on-call basis by a board-certified or board-eligible pediatrician capable of arriving on site within 30 minutes of notification.

E. The physician consultation and coverage for the specialty level and the subspecialty level newborn services shall be the same as for the lower level newborn services with the following exceptions:

1. Subdivision C 1 of this section shall not apply.

2. In-house physician consultation and coverage shall be provided 24 hours a day by a:

a. Board-certified or board-eligible neonatologist;

b. Board-certified or board-eligible pediatrician;

c. Second year or higher level pediatric resident; or

d. Neonatal nurse practitioner.

3. Whenever in-house coverage is provided as stated in subdivision 2 b, c, or d of this subsection, a board-certified or board-eligible neonatologist shall be on-call and available to be on site within 20 minutes of request.

F. The nursing direction, staff, and coverage required for the general level newborn service shall be as follows:

1. The neonatal nursing program shall be under the direction of a registered nurse.

2. The nursing director's responsibilities shall include:

a. Directing neonatal nursing services;

b. Guiding the development and implementation of neonatal nursing policies and procedures;

c. Collaborating with the medical staff; and

d. Consulting with referral hospitals with which a hospital has transfer agreements applicable to the services.

3. Each occupied unit of the newborn service shall be under the direct supervision of a registered nurse 24 hours a day. The registered nurse shall have documented competence in neonatal nursing appropriate to the level of service provided.

4. If a general level newborn nursery is organized as a separate nursing unit, staffing shall be based on a formula of a minimum of one nursing personnel to every eight newborns. Staffing shall include at least one registered nurse for the unit for each duty shift to provide direct supervision for nursing care.

5. If the postpartum and general level newborn units are organized as combined rooming-in or modified rooming-in units, staffing shall be based on a formula of one nursing personnel for every four mother-baby units. The rooming-in units shall always be staffed with no less than two nursing personnel assigned to each shift. One of the two nursing personnel shall be a registered nurse to provide direct supervision of nursing care.

6. When infants are present in the nursery, at least one nursing personnel trained in the care of newborn infants, with duties restricted to the care of the infants, shall be assigned to the nursery at all times. This nursing personnel is in addition to the registered nurse who is required to provide supervision.

7. To ensure adequate nursing staff for the nursery for normal newborns, duty schedules shall be developed and actual shift staffing shall occur according to the following minimum nurse-to-patient ratios:

a. 1:4 Recently born infants and those needing close observation.

b. 1:8 Newborns needing only routine care.

c. 1:4 Mother-newborn routine care.

8. Student nurses, licensed practical nurses, and nursing aides who assist in the nursing care of newborn infants shall be under the direct supervision of a registered nurse.

9. At least one nurse on each shift who is skilled in neonatal cardiopulmonary resuscitation must be immediately available to the nursery.

10. All nursing personnel assigned to the newborn service shall have orientation to the nursery, including orientation to patient care appropriate for the service level provided.

G. The nursing direction, staff, and coverage required of the intermediate level newborn service shall be the same as required of the general level newborn service with the following exceptions:

1. To ensure adequate nursing staff for the nursery, duty schedules shall be developed and actual shift staffing shall occur according to a ratio of at least one nurse to four neonates.

2. All registered nurses assigned to the newborn service shall be trained in neonatal CPR.

H. The nursing direction, staff, and coverage for the specialty level newborn service shall be the same as the lower level newborn service levels with the following exceptions:

1. The newborn nursery service shall have a nurse manager. The nurse manager shall be a registered nurse with advanced training and experience in the nursing management of high-risk neonates and their families. The responsibilities of the nurse manager shall include:

a. Daily management of the nursery;

b. Supervision and evaluation of nursing personnel assigned to the nursery;

c. Ensuring nursing coverage 24 hours a day; and

d. Implementing nursing policies and procedures at the service level.

2. All registered nurses shall have advanced training and experience in the management of neonatal patients, including specialized care technology and ventilator care for neonates. Only registered nurses with this advanced training and experience shall be assigned to care for neonates on ventilators.

3. To ensure adequate nursing staff for the nursery, duty schedules shall be developed and actual shift staffing shall occur according to a ratio of at least one nurse to three patients for neonates requiring specialty level care. For those neonates who have been assessed as no longer needing specialty level care, nurse to patient ratios shall be according to the neonate's appropriate level of service.

I. The nursing direction, staff, and coverage for the subspecialty level newborn service shall be the same as all lower levels of newborn services with the following exceptions:

1. A neonatal clinical nurse specialist shall be assigned to the nursery whose duties and responsibilities shall include staff consultation, collaboration, and teaching.

2. All registered nurses shall have advanced training and experience, beyond what is required of nurses in the lower level nurseries, in the management of high-risk neonates, including the care of unstable neonates with multisystem problems.

3. To ensure adequate nursing staff for the nursery, duty schedules shall be developed and actual shift staffing shall occur according to the following minimum nurse to patient ratios for neonates requiring subspecialty level care:

a. 1:2 Neonates requiring subspecialty level care; and

b. 1:1 Neonates requiring multisystem support.

For those neonates who have been assessed as no longer needing subspecialty level care, nurse to patient ratios shall be according to the neonate's appropriate level of service.

4. All nursing patient care shall be provided by registered nurses assigned to the subspecialty level nursery.

J. The governing body shall adopt written policies and procedures approved by the medical and nursing staff of the service for the medical care of newborns.

K. The policies and procedures for the general level nursery and all higher levels of newborn services shall include:

1. Medical criteria for the identification of high-risk neonatal patients.

2. Protocols for the management of all neonatal medical conditions that are routinely managed by the service as well as protocols for the stabilization and transfer of neonates that require a higher level of newborn service. These protocols shall be maintained in the nursery in addition to the telephone numbers of each nursery and the names of each referral newborn service medical director.

3. Written collaboration agreements with hospitals with higher levels of newborn services. A hospital may enter into more than one collaboration agreement. The collaboration agreements shall specifically identify those medical conditions that require consultation and may necessitate a neonatal transfer as well as the interim treatment required prior to transfer. Nothing in the regulation shall require a birth hospital to enter into a collaboration agreement with a referral hospital that disagrees with the medical, consultation, and transfer protocols adopted by the birth hospital. All neonatal transfers shall conform with § 1867 of the Social Security Act, its amendments in force to date, and implementing regulations. At the time of any transfer, the medical treatment at the referral hospital shall outweigh the risks to the neonate from affecting the transfer. The collaboration agreements shall include:

a. Criteria for neonatal transfer to the referral nursery;

b. Procedures for neonatal transport;

c. Back transfer criteria which provides for the return of the neonate to the referring hospital when medically appropriate;

d. Annual review by both parties of all cases of neonatal transfer;

e. Annual review by both parties of the collaboration agreements; and

f. Annual evaluation by both parties of the collaboration agreement and modification of the agreement, as necessary, as indicated by the evaluation results.

4. Establishment and maintenance of an ongoing, documented quality assurance program by the service that utilizes a multidisciplinary team of health practitioners and administrators for review and is integrated with the hospital's overall quality assurance program.

a. The quality assurance program shall include:

(1) Problem identification;

(2) Action plans;

(3) Evaluation; and

(4) Follow-up.

b. The quality assurance program shall include an annual review of the following:

(1) Neonatal transfer cases;

(2) Management of in-house neonatal cases; and

(3) Staff in-house in-service programs.

c. Outcome statistics, including morbidity, mortality, and the appropriateness of neonatal transfers, shall be compiled in a standardized manner and reviewed quarterly by a multidisciplinary committee.

5. Immediate resuscitation and stabilization of the sick neonate in accordance with current CPR standards of the American Heart Association and the American Academy of Pediatrics.

6. Care of newborns after delivery to include the following:

a. Care of eyes, skin, and umbilical cord and the provision of a single parenteral dose of Vitamin K-1, water soluble, as a prophylaxis against hemorrhagic disorder;

b. Maintenance of the newborn's airway, respiration, and body temperature; and

c. Assessment of the newborn and recording of the one-minute and five-minute Apgar scores.

7. Performance of prophylaxis against ophthalmia neonatorum by the administration of a 1.0% solution of silver nitrate aqueous solution, erythromycin, or tetracycline ointment or solution. This process is to be performed within one hour of delivery with documentation entered in the newborn's medical record. The process may be performed in the nursery.

8. Clamping or tying of the umbilical cord and, when indicated, collecting a sample of cord blood.

9. Performance of Rh type and Coombs' test for every newborn born to a Rh negative mother and performing major blood grouping and Coombs' tests when indicated for every newborn born to an O blood group mother or a mother with a family history of blood incompatibility. If such qualitative tests are performed, the results shall be documented in the newborn's medical record.

10. Identification and treatment of hyperbilirubinemia and hypoglycemia.

11. Identification of each newborn, prior to leaving the delivery room, with two identification bands fastened on the newborn and one identification band fastened on the mother. The newborn's medical record shall accompany the infant from the delivery room.

12. Newborn transport, within the hospital, of all newborns who are either premature or compromised by using a heated bassinet equipped with oxygen, a transport incubator, or other similar equipment.

13. Registered nurse or physician assessment of a newborn within one hour after delivery and documentation of the assessment in the newborn's medical record. Assessment in the delivery area is permitted if the hospital permits a newborn and the mother to remain together during the immediate post-delivery period.

14. Delineation of how infants are to be monitored during stays with their mothers and under what circumstances infants must be taken to the nursery immediately after delivery and not allowed to remain with their mothers.

15. Physician examination of the newborn consistent with guidelines of the American Academy of Pediatrics. A high-risk newborn shall be examined upon admission to the nursery.

16. Ensuring that every bassinet and incubator in the nursery bears the identification of the newborn's last name, sex, date and time of birth, the mother's last name, and the attending physician's name.

17. The management of mothers who utilize breast milk with their newborns. Breast milk shall be collected in aseptic containers, dated, stored under refrigeration, and consumed or disposed of within 96 hours of collection if the breast milk has not been frozen. This policy pertains to breast milk collected while in the hospital or at home for hospital use.

18. Preparation and use of formula, including:

a. The distribution of feeding units immediately after assembly;

b. The use of prepared formula only within the time period designated on the package; and

c. The use of presterilized formula only, except in the case of facility-defined emergencies.

19. Screening newborns for risk factors associated with hearing impairment as required in §§ 32.1-64.1 and 32.1-64.2 of the Code of Virginia and in accordance with the Regulations for Administration of the Virginia Hearing Impairment Identification and Monitoring System (12VAC5-80).

20. Screening and treatment of genetic, metabolic, and other diseases identifiable in the newborn period as specified in § 32.1-65 of the Code of Virginia and in accordance with the Regulations Governing Virginia Newborn Screening Services ( 12VAC5-71).

21. Reporting to the Virginia Department of Health all required reportable congenital defects.

22. Visitor contact with the newborn, including newborns delivered by cesarean section and premature, sick, congenitally malformed, and dying newborns.

23. Completion of birth certificates.

24. Discharge planning appropriate for the needs of the patient for at-risk infants.

L. The additional policies and procedures required for the intermediate level newborn service shall include:

1. Insertion and maintenance of peripheral intravenous lines and use of pediatric infusion pumps that are accurate to plus or minus one milliliter an hour;

2. Insertion and maintenance of umbilical arterial lines and the use of pediatric infusion pumps accurate to plus or minus one milliliter an hour;

3. Use of heated, humidified, and blended supplemental oxygen by hood with a recording of oxygen levels every hour using a calibrated constant oxygen analyzer. The policy shall address consultation with a higher level nursery identified in the collaboration agreement when oxygen levels exceed 40% and remain at 40% or greater for a period of four hours or more;

4. Administration of nasogastric or orogastric feedings;

5. Use of saturation monitor (pulse oximeter or equivalent) for any newborn requiring supplemental oxygen;

6. Use of assisted ventilation in preparation for transport;

7. Initiation of PgE1 prior to transport; and

8. Administration of blood components and a policy for provision of partial and total exchange transfusions.

M. The additional policies and procedures required for the specialty level newborn service shall include:

1. Provision of ongoing assisted ventilation;

2. Administration of surfactant;

3. Preparation and administration of total parenteral nutrition (TPN);

4. Initiation and maintenance of pressor medications;

5. Provision for developmental follow up;

6. Insertion and maintenance of central umbilical arterial catheters or peripheral arterial lines with constant pressure monitoring;

7. Placement of chest tubes with water seal on an emergency basis;

8. Use of heated, humidified, and blended supplemental oxygen by hood with a recording of oxygen levels every hour using a calibrated constant oxygen analyzer;

9. Administration and maintenance of CPAP including the requirement for in-house physician coverage;

10. Daily availability of appropriate drug peak and trough assays on one milliliter or less of blood;

11. Cardioversion capability specific for newborns; and

12. Provision for ophthalmology consult and requirements regarding the examination of high-risk newborns.

N. The additional policies and procedures required for the subspecialty level newborn service shall include:

1. Provision for returning patients to the operating room within 30 minutes, if indicated;

2. Provision for echocardiography evaluation;

3. Provision for patient treatment on an extracorporeal membrane oxygenator (ECMO) or a written collaboration agreement with a hospital with this capability;

4. Provision for maintenance of central venous pressure monitoring; and

5. Provision for the maintenance of neonates on prostaglandin E1 (PgE1).

O. A hospital with an emergency department or labor and delivery services, freestanding emergency department, or birthing center as defined in § 63.2-1914 of the Code of Virginia shall implement standardized protocols for identifying and responding to obstetric emergencies, including obstetric hemorrhage, preeclampsia, eclampsia, and other life-threatening conditions based on the protocols developed by the Virginia Neonatal Perinatal Collaborative.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Former 12VAC5-41-440 D 3 to 6 derived from VR 355-33-500 § 2.28, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 11, Issue 16, eff. June 1, 1995; Volume 11, Issue 21, eff. August 10, 1995; amended and adopted as 12VAC5-410-444, Virginia Register Volume 21, Issue 6, eff. February 14, 2005; Errata, 21:8 VA.R. 1016 December 27, 2004; amended, Virginia Register Volume 22, Issue 8, eff. January 25, 2006; Errata, 22:9 VA.R. 1437 January 9, 2006; amended, Virginia Register Volume 42, Issue 5, eff. November 19, 2025; Volume 42, Issue 18, eff. June 4, 2026.

12VAC5-410-445 Newborn service design and equipment criteria

A. Construction or renovation of a hospital's nursery shall be consistent with (i) section 2.2-2.11 of Part 2 of the Guidelines for Design and Construction of Hospitals, 2022 Edition (The Facility Guidelines Institute) and (ii) the Virginia Uniform Statewide Building Code (13VAC5-63). Hospitals with higher-level nurseries shall comply with section 2.2-2.9 of Part 2 of the 2022 edition of the guidelines as applicable.

B. The hospital shall provide the following equipment in the general level nursery and all higher level nurseries, unless additional equipment requirements are imposed for the higher level nurseries:

1. Resuscitation equipment as specified for the delivery room in 12VAC5-410-442 G 2 shall be available in the nursery at all times;

2. Equipment for the delivery of 100% oxygen concentration, properly heated, blended, and humidified, with the ability to measure oxygen delivery in fractional inspired concentration (FI02). The oxygen analyzer shall be calibrated every eight hours and serviced according to the manufacturer's recommendations by a member of the hospital's respiratory therapy department or other responsible personnel trained to perform the task;

3. Saturation monitor (pulse oximeter or equivalent);

4. Equipment for monitoring blood glucose;

5. Infant scales;

6. Intravenous therapy equipment;

7. Equipment and supplies for the insertion of umbilical arterial and venous catheters;

8. Open bassinets, self-contained incubators, open radiant heat infant care system or any combination of this equipment appropriate to the service level;

9. Equipment for stabilization of a sick infant prior to transfer that includes a radiant heat source capable of maintaining an infant's body temperature at 99°F;

10. Equipment for insertion of a thoracotomy tube; and

11. Equipment for proper administration and maintenance of phototherapy.

C. The additional equipment required for the intermediate level newborn service and for any higher service level is:

1. Pediatric infusion pumps accurate to plus or minus 1 milliliter (ml) per hour;

2. On-site supply of PgE1;

3. Equipment for 24-hour cardiorespiratory monitoring for neonatal use available for every incubator or radiant warmer;

4. Saturation monitor (pulse oximeter or equivalent) available for every infant given supplemental oxygen;

5. Portable x-ray machine; and

6. If a mechanical ventilator is selected to provide assisted ventilation prior to transport, it shall be approved for the use of neonates.

D. The additional equipment required for the specialty level newborn service and a higher newborn service is as follows:

1. Equipment for 24-hour cardiorespiratory monitoring with central blood pressure capability for each neonate with an arterial line;

2. Equipment necessary for ongoing assisted ventilation approved for neonatal use with online capabilities for monitoring airway pressure and ventilation performance;

3. Equipment and supplies necessary for insertion and maintenance of chest tube for drainage;

4. On-site supply of surfactant;

5. Computed axial tomography equipment (CAT) or magnetic resonance imaging equipment (MRI);

6. Equipment necessary for initiation and maintenance of continuous positive airway pressure (CPAP) with ability to constantly measure delineated pressures and including alarm for abnormal pressure (i.e., vent with PAP mode); and

7. Cardioversion unit with appropriate neonatal paddles and ability to deliver appropriate small watt discharges.

E. The hospital shall document that it has the appropriate equipment necessary for any of the neonatal surgical and special procedures it provides that are specified in its medical protocol and that are required for the specialty level newborn service.

F. The additional equipment requirements for the subspecialty level newborn service are:

1. Equipment for emergency gastrointestinal, genitourinary, central nervous system, and sonographic studies available 24 hours a day;

2. Pediatric cardiac catheterization equipment;

3. Portable echocardiography equipment; and

4. Computed axial tomography equipment (CAT) and magnetic resonance imaging equipment (MRI).

G. The hospital shall document that it has the appropriate equipment necessary for any of the neonatal surgical and special procedures it provides that are specified in the medical protocol and are required for the subspecialty level newborn service.

History

• Statutory Authority: §§ 32.1-12, 32.1-127, and 32.1-127.001 of the Code of Virginia.
• Historical Notes: Former 12VAC5-41-440 D 7 and 8 derived from VR 355-33-500 § 2.28, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 11, Issue 16, eff. June 1, 1995; Volume 11, Issue 21, eff. August 10, 1995; amended and adopted as 12VAC5-410-445, Virginia Register Volume 21, Issue 6, eff. February 14, 2005; amended, Virginia Register Volume 22, Issue 8, eff. January 25, 2006; Volume 23, Issue 10, eff. March 1, 2007; Volume 26, Issue 22, eff. August 4, 2010; Volume 37, Issue 19, eff. June 9, 2021; Volume 42, Issue 18, eff. June 4, 2026.

12VAC5-410-446 Newborn support services and other resources

A. The support services and other resources required for the general level newborn service and all higher levels of newborn services shall be as follows:

1. Clinical laboratory services and blood bank services available in the hospital on a 24-hour basis. Laboratory and blood bank personnel available on-site or on-call on a 24-hour basis;

2. Group O Rh negative blood available from the blood bank at all times and the blood bank's ability to provide correctly matched blood within 45 minutes of request;

3. Hospital laboratory and blood bank personnel capability to perform the following tests with less than 1.0 ml of blood within one hour or less of request if specified: (i) blood group and Rh type determination/cross-matching, (ii) arterial blood gases within 20 minutes, (iii) blood glucose within 20 minutes, (iv) complete blood count, (v) total protein and albumin, (vi) total and direct bilirubin, (vii) direct Coombs' test, (viii) electrolytes, (ix) blood urea nitrogen, (x) clotting profile (may require more than one ml of blood); and

4. Portable radiological services for basic radiologic studies in the nursery available on-call, within 30 minutes of request, on a 24-hour basis.

B. The additional support services and resources required of the intermediate level newborn service shall be as follows:

1. A respiratory therapist in-house 24 hours a day. The therapist shall have orientation to the neonatal nursery, including orientation to the appropriate level of care. The therapist shall have documented competence in neonatal respiratory care;

2. A radiology technician in-house 24 hours a day;

3. An ultrasound technician available on-call 24 hours a day;

4. A laboratory technician in-house 24 hours a day;

5. A blood bank technician available on call within 30 minutes of request;

6. A licensed physical therapist or certified occupational therapist available for consultation;

7. A registered dietitian with documented competence in neonatal nutrition available for consultation;

8. A biomedical technician, available to the nursery, responsible for the maintenance and safe functioning of specialized medical equipment;

9. Microvolume assays for xanthines and aminoglycosides available within 12 hours of request;

10. Blood gases to be performed on 0.25 ml or less heparinized blood within 20 minutes of request;

11. Blood components available within two hours of request; and

12. Portable chest x-ray within 20 minutes of request.

C. The specialty level support services and resources that are required in addition to the requirements for the lower level nurseries are as follows:

1. A blood bank technician in-house 24 hours a day;

2. A pharmacist with documented competence in neonatal pharmacology on staff;

3. A licensed physical therapist or certified occupational therapist with documented competence in neonatal care;

4. A medical social worker as a participating member of the service;

5. An ultrasound technician on-call 24 hours a day; and

6. A registered dietitian with documented competence in neonatal nutrition as a participating member of the service.

D. The subspecialty level support services and resources that are required in addition to the requirements of the lower level nurseries are as follows:

1. A radiologist with documented competence in the interpretation of pediatric and neonatal films readily available for providing pediatric and neonatal x-ray procedures and ultrasound interpretation;

2. A developmental pediatrician on staff;

3. A cardiothoracic surgeon with documented competence in pediatric surgical procedures on staff and on-call 24 hours a day;

4. A pediatric surgeon on staff and on-call 24 hours a day;

5. An anesthesiologist with documented competence in neonatal anesthesiology on-call 24 hours a day;

6. The following pediatric subspecialists on staff available to be on-site within 30 minutes of request 24 hours a day:

a. Cardiology;

b. Endocrinology;

c. Gastroenterology;

d. Genetics;

e. Hematology;

f. Immunology;

g. Infectious diseases;

h. Metabolism;

i. Nephrology;

j. Neurology;

k. Nutrition;

l. Pharmacology; and

m. Pulmonology;

7. The following pediatric surgical subspecialists on staff available to be on-site within 30 minutes of request 24 hours a day:

a. Neurosurgeon;

b. Ophthalmologist;

c. Orthopedic surgeon;

d. Otolaryngologic surgeon; and

e. Urologic surgeon;

8. An echocardiography technician on staff;

9. An American College of Medical Genetics certified or eligible genetics counselor on staff;

10. In-house 24-hour capability for microchemistries;

11. Hospital resources to provide for the medical follow up of discharged, high-risk neonates that incorporate a parent education program that includes, but is not limited to, the following:

a. Pediatric cardiopulmonary resuscitation training;

b. Home cardiopulmonary monitoring;

c. Home oxygen monitoring; and

d. Lactation instruction;

12. Hospital resources to provide comprehensive, neonatal continuing education to health professionals external to the hospital;

13. A referral network for cardiovascular surgical consultation; and

14. The operation of a neonatal transport system on a 24-hour basis. Transports shall be initiated within 30 minutes of request. The neonatal transport system shall operate in accordance with the most current editions of the Guidelines for Air and Ground Transport of Neonatal and Pediatric Patients published by the American Academy of Pediatrics and the Neonatal Transport Standards and Guidelines published by the National Association of Neonatal Nurses.

History

• Statutory Authority: § 32.1-127 of the Code of Virginia.
• Historical Notes: Former 12VAC5-41-440 D 9 derived from VR 355-33-500 § 2.28, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 11, Issue 16, eff. June 1, 1995; Volume 11, Issue 21, eff. August 10, 1995; amended and adopted as 12VAC5-410-446, Virginia Register Volume 21, Issue 6, eff. February 14, 2005.

12VAC5-410-447 Combined obstetric and clean gynecological service; infection control

A. A hospital may combine obstetric and clean gynecological services. The hospital shall define clean gynecological cases in written hospital policy. A combined obstetric and clean gynecologic service shall be organized under written policies and procedures. The policies and procedures shall be approved by the medical and nursing staff of these services and adopted by the governing body and shall include the following requirements:

1. Cesarean section and obstetrically related surgery, other than vaginal delivery, shall be carried out in designated operating or delivery rooms. Vaginal deliveries may be performed in designated delivery or operating rooms that are used solely for obstetric or clean gynecologic procedures.

2. Clean gynecological cases may be admitted to the postpartum nursing unit of the obstetric service according to procedures determined by the obstetrics and gynecologic staff and the hospital's infection control committee.

3. Only members of the medical staff with approved privileges shall admit and care for patients in the combined service area. These admissions shall be subject to the medical staff bylaws.

4. Hospitals with a combined service shall limit admission to the service to those patients allowed by policies adopted by the obstetric and gynecological medical staff and the hospital's infection control committee.

5. Unoccupied beds shall be reserved daily in a combined service ready for use by obstetric patients.

6. Patients admitted to the combined service may be taken to radiology or other hospital departments for diagnostic procedures, before or after surgery, if it is not evident that these procedures may be hazardous to the patients or to other patients on the combined service.

7. Patients may receive postpartum or immediate postoperative care in the general recovery room prior to being returned to the combined service area if the following conditions prevail:

a. The recovery room or intensive care unit is a separate unit adjacent to or part of the general surgical operating suite or delivery suite; and

b. The recovery room is under the direct supervision of the chairman of the anesthesiology department of the hospital.

In separate obstetric recovery rooms, supervision shall be provided by the obstetrician in charge or by physicians approved by the medical staff of the combined service.

8. Nursing care of all patients shall be supervised by a registered nurse.

9. Nursing care of both obstetrical and gynecological patients may be given by the same nursing personnel.

10. Visitor regulations applicable to visitors of obstetric patients shall also apply to visitors of other patients admitted to the combined service.

B. In addition to the infection control requirements specified in 12VAC5-410-490, the hospital's infection control committee, in cooperation with the obstetric and newborn medical and nursing staff, shall establish written policies and procedures for infection control within the obstetric and newborn services. The policies and procedures shall be adopted by the governing body and shall include:

1. The establishment of criteria for determining infection-related maternal and newborn morbidity;

2. Written criteria for the isolation or segregation of mothers and newborns, in accordance with Guidelines for Perinatal Care, 8th Edition, 2017 (American Academy of Pediatrics/American College of Obstetricians and Gynecologists) and Control of Communicable Diseases Manual, 21st Edition, 2022 (American Public Health Association) to include:

a. Birth prior to admission to the facility;

b. Birth within the facility but prior to admission to the labor and delivery area;

c. Readmission to the service after transfer or discharge;

d. Presence of infection;

e. Elevated temperature; and

f. Presence of rash, diarrhea, or discharging skin lesions;

3. Written policies and procedures for the isolation of patients in accordance with Guidelines for Perinatal Care, 8th Edition, 2017 (American Academy of Pediatrics/American College of Obstetricians and Gynecologists) and Control of Communicable Diseases Manual, 21st Edition, 2022 (American Public Health Association) including:

a. Ensuring that a physician orders and documents in the patient's medical record the placement of a mother or newborn in isolation;

b. Ensuring that at least one labor room is available for use by a patient requiring isolation;

c. Provisions for the isolation of a mother and newborn together (rooming-in) or separately; and

d. Policies and procedures for assigning nursing personnel to care for patients in isolation;

4. Control of traffic, including personnel and visitors. Policies and procedures shall be established in the event that personnel from other services must work in the obstetric and newborn services or personnel from the obstetric and newborn services must work on other services. Appropriate clothing changes and handwashing shall be required of any individual prior to assuming temporary assignments or substitution from any other area or service in the hospital;

5. Determination of the health status of personnel, and control of personnel with symptoms of communicable infectious disease;

6. Review of cleaning procedures, agents, and schedules in use in the obstetric and newborn services. Incubators or bassinets shall be cleaned with detergent and disinfectant registered by the U.S. Environmental Protection Agency each time a newborn occupying it is discharged or at least every seven days;

7. Techniques of patient care, including handwashing and the use of protective clothing, such as gowns, masks, and gloves; and

8. Infection control in the nursery, including:

a. Closing of the nursery immediately in the event of an epidemic, as determined by the infection control director in consultation with the medical director and the Virginia Department of Health;

b. Assigning a newborn to a clean incubator or bassinet at least every seven days;

c. Using an impervious cover that completely covers the surface of the scale pan if newborns are weighed on a common scale, and changing the cover after each newborn is weighed;

d. Gowning in isolation cases; and

e. Requiring nursery personnel wear clean scrub attire in the nursery when handling infants. Appropriate cover garments shall be worn over scrub attire when personnel are holding infants. Personnel shall wash their hands after contact with each patient and upon entering or leaving the nursery.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Former 12VAC5-41-440 E and F derived from VR 355-33-500 § 2.28, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 11, Issue 16, eff. June 1, 1995; Volume 11, Issue 21, eff. August 10, 1995; amended and adopted as 12VAC5-410-447, Virginia Register Volume 21, Issue 6, eff. February 14, 2005; amended, Virginia Register Volume 42, Issue 18, eff. June 4, 2026.

12VAC5-410-450 Psychiatric service

A. The psychiatric service shall be under the supervision of a physician, licensed by the Board of Medicine, who meets the qualifications of the medical staff bylaws.

B. Psychiatric units shall conform to the applicable licensure requirements pursuant to 12VAC35-105.

C. Every hospital that provides inpatient psychiatric services shall establish written policies for denial of admission of medically stable patients in its psychiatric unit. The policies shall include language that:

1. If a medically stable patient is referred to a hospital's psychiatric unit and denied admission, the referring physician may request direct verbal communication with the on-call physician at the referral hospital; and

2. Prohibits on-call physicians or other hospital staff from refusing a request from the referring physician for direct verbal communication.

D. Every hospital that provides inpatient psychiatric services shall establish a protocol that requires for any refusal to admit a patient for whom there is a question regarding the medical stability or medical appropriateness of admission for inpatient psychiatric services due to a situation involving results of a toxicology screening, the on-call physician in the psychiatric unit to which the patient is sought to be transferred to participate in direct verbal communication, either in person or via telephone, with a clinical toxicologist or other person who is a certified specialist in poison information employed by a poison control center that is accredited by the American Association of Poison Control Centers to review the results of the toxicology screen and determine whether a medical reason for refusing admission to the psychiatric unit related to the results of the toxicology screen exists if requested by the referring physician.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.29, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 22, Issue 8, eff. January 25, 2006; Volume 34, Issue 11, eff. February 21, 2018; Volume 35, Issue 4, eff. November 14, 2018.

12VAC5-410-460 Special care units

A. As used in this section, special care units may be multipurpose or include but not be limited to units for: intensive care, burn care, coronary care, pulmonary care, rehabilitation, and hemodialysis.

B. Special care units shall have a defined organization. Each unit shall be designed and equipped for the defined special functions. Each special care unit shall be governed by written policies and procedures specifically relating to utilization of the service.

C. Each unit shall be under the direction of a physician qualified by training and experience in the specialty care in accordance with medical staff bylaws.

D. Personnel shall be provided based on the scope and complexity of the services provided.

E. The hospital shall have a written plan for a continuing education program developed specifically for personnel of special care units.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.30, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-465 Long-term care nursing services

A. The provisions of this section shall apply to a general hospital's long-term care nursing unit if that unit is a certified nursing facility. The general hospital shall be responsible for ensuring that its long-term care nursing unit meets the requirements of this section.

B. For the purposes of this section, "resident" means any person admitted to a general hospital's long-term care nursing unit.

C. A long-term care nursing unit shall fully disclose to the applicant for admission the unit's admissions policies, including any preferences given.

D. A long-term care nursing unit shall train, or arrange for training of, all employees who work in the long-term care unit and who are mandated to report adult abuse, neglect, or exploitation pursuant to § 63.2-1606 of the Code of Virginia on such reporting procedures and the consequences for failing to make a required report.

E. A long-term care nursing unit shall register with the Department of State Police to receive notice of the registration, reregistration, or verification of registration information of any person required to register with the Sex Offender and Crimes Against Minors Registry pursuant to Chapter 9 (§ 9.1-900 et seq.) of Title 9.1 of the Code of Virginia within the same or a contiguous zip code area in which the long-term care nursing unit is located, pursuant to § 9.1-914 of the Code of Virginia.

F. If a long-term care nursing unit anticipates that a potential resident will have a length of stay greater than three days or in fact stays longer than three days, the long-term care nursing unit shall ascertain, prior to admission, whether the potential resident is required to register with the Sex Offender and Crimes Against Minors Registry pursuant to Chapter 9 of Title 9.1 of the Code of Virginia.

G. Upon the request of the unit's family council, a long-term care nursing unit shall send notices and information about the family council mutually developed by the family council and the administration of the unit, and provided to the unit for such purpose, to the listed responsible party or a contact person of the resident's choice up to six times per year.

1. Such notices may be included together with a monthly billing statement or other regular communication.

2. Notices and information shall also be posted in a designated location within the unit.

3. No family member of a resident or other resident representative shall be restricted from participating in meetings in the unit with the families or resident representatives of other residents in the unit.

H. A general hospital shall maintain for its long-term care unit liability insurance coverage in a minimum amount of $1 million and professional liability coverage in an amount at least equal to the recovery limit set forth in § 8.01-581.15 of the Code of Virginia to compensate residents or individuals for injuries and losses resulting from the negligent or criminal acts of the unit.

I. During a public health emergency related to COVID-19, a long-term care unit shall establish a protocol to allow each resident to receive visits, consistent with guidance from the CDC and as directed by CMS and the board, which shall include:

1. Provisions describing:

a. The conditions, including conditions related to the presence of COVID-19 in the long-term care nursing unit and community, under which in-person visits will be allowed and under which in-person visits will not be allowed and visits will be required to be virtual;

b. The requirements with which in-person visitors will be required to comply to protect the health and safety of the residents and staff of the long-term care nursing unit;

c. The types of technology, including interactive audio or video technology, and the staff support necessary to ensure visits are provided as required by this subsection; and

d. The steps the long-term care unit will take in the event of a technology failure, service interruption, or documented emergency that prevents visits from occurring as required by this subsection;

2. A statement of the frequency with which visits, including virtual and in-person, where appropriate, will be allowed, which shall be at least once every 10 calendar days for each resident;

3. A provision authorizing a resident or the resident's personal representative to waive or limit visitation, provided that such waiver or limitation is included in the resident's health record; and

4. A requirement that the general hospital publish on its website or communicate to each resident or the resident's authorized representative, in writing or via electronic means, the long-term care unit's plan for providing visits to residents as required by this subsection.

J. Unless the vaccination is medically contraindicated or the resident declines the offer of vaccination, a general hospital shall provide or arrange for the administration to residents of an annual influenza vaccination and a pneumococcal vaccination in accordance with the following recommendations of ACIP:

1. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2022–23 Influenza Season, MMWR 71 (1), 2022, CDC;

2. Use of 15-Valent Pneumococcal Conjugate Vaccine and 20-Valent Pneumococcal Conjugate Vaccine Among U.S. Adults: Updated Recommendations of ACIP — United States, MMWR 71 (4), 2022, CDC;

3. Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine Among Adults Aged >65 Years: Updated Recommendations of ACIP, MMWR 68 (46), 2019, CDC;

4. Intervals Between PCV13 and PPSV23 Vaccines: Recommendations of ACIP, MMWR 64 (15), 2015, CDC;

5. Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine Among Adults Aged >65 Years: Recommendations of ACIP, MMWR 63 (37), 2014, CDC;

6. Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine Among Children Aged 6–18 Years with Immunocompromising Conditions: Recommendations of ACIP, MMWR 62 (25), 2013, CDC;

7. Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine for Adults with Immunocompromising Conditions: Recommendations of ACIP, MMWR 61 (40), 2012, CDC;

8. Prevention of Pneumococcal Disease Among Infants and Children — Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine: Recommendations of ACIP, MMWR 59 (RR-11), 2010, CDC; and

9. Updated Recommendations for Prevention of Invasive Pneumococcal Disease Among Adults Using the 23-Valent Pneumococcal Polysaccharide Vaccine (PPSV23), MMWR 59 (34), 2010, CDC.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 42, Issue 18, eff. June 4, 2026.

12VAC5-410-470 Outpatient (ambulatory care)

A. All hospital outpatient (ambulatory care) services shall conform to all applicable rules and regulations herein, since such services are an integral part of the hospital and covered by its licensure.

B. Freestanding outpatient surgical hospitals shall comply with the provisions of Part IV of this chapter.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.31, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

Article 4 Environmental and Maintenance Services

12VAC5-410-480 Housekeeping service

Article 4 Environmental and Maintenance Services

A. Written housekeeping procedures shall be established for the cleaning of all areas in the hospital and copies posted in appropriate areas.

B. All parts of the hospital and its premises shall be kept clean, neat, and free of litter and rubbish.

C. Equipment and supplies shall be provided for cleaning of all surfaces. Such equipment shall be maintained in a safe and sanitary condition.

D. Cleaning solutions and substances shall be labeled, stored in a safe place, and kept separate from food storage and patient care supplies.

E. Cleaning shall be performed in a manner which will minimize the spread of pathogenic organisms in the hospital atmosphere.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.32, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 22, Issue 8, eff. January 25, 2006.

12VAC5-410-490 Infection control

A. Each hospital shall have an infection control committee to perform at least the following functions:

1. Establish a hospital-wide infection surveillance program and designate an infection control officer to conduct all infection surveillance activities and to maintain appropriate records to include infection rates by body site and clinical service and all hospital acquired blood stream pathogens.

2. Establish written policies governing the admission and isolation, including protective isolation, of patients with known or suspected infectious diseases.

3. Develop, periodically evaluate, and revise as needed, infection control policies, procedures and techniques for all appropriate phases of hospital operation and service in order to protect patients, employees, and visitors. These policies shall include, but are not limited to, appropriate employee health screening and immunization and acceptable techniques and practices for high risk procedures such as parenteral hyperalimentation, urinary tract catheterization, dialysis, and intravenous therapy.

B. An educational program on infection control for all appropriate personnel shall be conducted.

C. The hospital shall report promptly to its local health department diseases designated as "reportable" according to 12VAC5-90-80 when such cases are admitted to or are diagnosed in the hospital and shall report any outbreak of infectious disease, including nosocomial infections, as required by 12VAC5-90. An outbreak is defined as an increase in incidence of any infectious disease above the usual incidence at the hospital.

In addition, two or more epidemiologically related infections, including, but not limited to, staphylococcus aureus, group A beta hemolytic streptococcus, and salmonella species occurring in the obstetrical or nursery units shall be reported through the local health department.

D. Accumulated waste, including all contaminated sharps, dressings, or similar infectious waste, shall be disposed of in a manner compliant with the OSHA Bloodborne Pathogens standard (29 CFR 1910.1030).

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.33, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 22, Issue 8, eff. January 25, 2006.

12VAC5-410-500 Laundry service

A. Hospitals providing laundry service shall have adequate facilities and equipment for the safe and effective operation of such service. Those areas used for storage and handling of soiled linens shall be negatively pressurized or vented to the outside.

B. Special procedures shall be established for the handling and processing of contaminated linens.

C. All soiled linen shall be placed in closed containers prior to transportation.

D. To safeguard clean linens from cross-contamination, they shall be:

1. Transported in containers used exclusively for clean linens unless such containers are routinely and regularly sanitized before use as a clean linen transport container and shall be kept covered at all times while in transit; and

2. Stored in areas designated exclusively for this purpose.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 2.34, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 22, Issue 8, eff. January 25, 2006.

12VAC5-410-510 (Repealed.)

Historical Notes

Derived from VR355-33-500 §§ 2.35 to 2.48, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; repealed, Virginia Register Volume 22, Issue 8, eff. January 25, 2006.

12VAC5-410-650 General building and physical plant information

A. All construction of new buildings and additions, renovations, or alterations of existing buildings for occupancy as a hospital shall conform to state and local codes, zoning ordinances, and the Virginia Uniform Statewide Building Code (13VAC5-63).

In addition, hospitals shall be designed and constructed consistent with Part 1 and Part 2 of the Guidelines for Design and Construction of Hospitals, 2022 Edition (The Facility Guidelines Institute ), as amended by the December 2024 Errata for Guidelines for Design and Construction of Hospitals, 2022 Edition (The Facility Guidelines Institute), and if applicable, Chapter 2.8 of Part 2 of the Guidelines for Design and Construction of Outpatient Facilities, 2022 Edition (The Facility Guidelines Institute), as amended by the January 2025 Errata for the Guidelines for Design and Construction of Outpatient Facilities, 2022 Edition (The Facility Guidelines Institute).

B. Architectural drawings and specifications for all new construction or for additions, alterations, or renovations to any existing building shall be dated, stamped with professional seal, and signed by the architect. The architect shall certify that the drawings and specifications were prepared to conform to the Virginia Uniform Statewide Building Code (13VAC5-63) and be consistent with Part 1 and Part 2 of the Guidelines for Design and Construction of Hospitals, 2022 Edition (The Facility Guidelines Institute), as amended by the December 2024 Errata for Guidelines for Design and Construction of Hospitals, 2022 Edition (The Facility Guidelines Institute), and if applicable, Chapter 2.8 of the Guidelines for Design and Construction of Outpatient Facilities, 2022 Edition (The Facility Guidelines Institute), as amended by the January 2025 Errata for the Guidelines for Design and Construction of Outpatient Facilities, 2022 Edition (The Facility Guidelines Institute).

History

• Statutory Authority: §§ 32.-12, 32.1-127, and 32.1-127.001 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 3.1, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 22, Issue 8, eff. January 25, 2006; Volume 23, Issue 10, eff. March 1, 2007; Volume 26, Issue 22, eff. August 4, 2010; Volume 37, Issue 19, eff. June 9, 2021; Volume 42, Issue 18, eff. June 4, 2026.

12VAC5-410-655 Additional building regulations and standards

A. The use of an incinerator shall require permitting from the nearest regional permitting office for the Department of Environmental Quality.

B. Water shall be obtained from an approved water supply system. Hospitals shall be connected to sewage systems approved by the Department of Health or the Department of Environmental Quality.

C. Each hospital shall establish a monitoring program for the internal enforcement of all applicable fire and safety laws and regulations.

D. All radiological machines shall be registered with the Office of Radiological Health of the Virginia Department of Health. Installation, calibration and testing of machines and storage facilities shall comply with 12VAC5-480.

E. A hospital's food services operation shall comply with 12VAC5-421.

F. Hospital pharmacy services shall comply with Chapter 33 (§ 54.1-3300 et seq.) of Title 54.1 of the Code of Virginia and 18VAC110-20.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 8, eff. January 25, 2006.

12VAC5-410-660 (Repealed.)

Historical Notes

Derived from VR355-33-500 §§ 3.2-3.7, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; repealed, Virginia Register Volume 22, Issue 8, eff. January 25, 2006.

12VAC5-410-720 Drawings and specifications

A. Architectural drawings and specifications for all new construction or for additions, alterations or renovations to any existing building shall be dated, stamped with licensure seal and signed by the architect. The architect shall certify that the drawings and specifications were prepared to conform to building code requirements. The certification shall be forwarded to the OLC.

B. Additional approval may include a Certificate of Public Need.

C. Upon completion of the construction, the hospital shall maintain a complete set of legible "as built" drawings showing all construction, fixed equipment, and mechanical and electrical systems, as installed or built.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 3.8, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 11, Issue 16, eff. June 1, 1995; Volume 22, Issue 8, eff. January 25, 2006; Volume 23, Issue 10, eff. March 1, 2007.

12VAC5-410-730 (Repealed.)

Historical Notes

Derived from VR355-33-500 §§ 3.9-3.11, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 11, Issue 16, eff. June 1, 1995; repealed, Virginia Register Volume 22, Issue 8, eff. January 25, 2006.

12VAC5-410-760 Long-term care nursing units

Construction and renovation of long-term care nursing units, including intermediate and skilled nursing care nursing units, shall be designed and constructed consistent with section 2.2-2.15 of Part 2 of the Guidelines for Design and Construction of Hospitals, 2022 Edition (The Facility Guidelines Institute ).

Architectural drawings and specifications for all new construction or for additions, alterations, or renovations to any existing building shall be dated, stamped with professional seal, and signed by the architect. The architect shall certify that the drawings and specifications were prepared to conform to the Virginia Uniform Statewide Building Code (13VAC5-63) and be consistent with section 2.2-2.15 of Part 2 of the Guidelines for Design and Construction of Hospitals, 2022 Edition (The Facility Guidelines Institute).

History

• Statutory Authority: §§ 32.1-12, 32.1-127, and 32.1-127.001 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 3.12, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 22, Issue 8, eff. January 25, 2006; Volume 23, Issue 10, eff. March 1, 2007; Volume 37, Issue 19, eff. June 9, 2021; Volume 42, Issue 18, eff. June 4, 2026.

12VAC5-410-770 (Repealed.)

Historical Notes

Derived from VR355-33-500 §§ 3.13-3.50, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 11, Issue 16, eff. June 1, 1995; repealed, Virginia Register Volume 22, Issue 8, eff. January 25, 2006.

Article 1 Organization and Management

12VAC5-410-1150 Governing authority

Article 1 Organization and Management

A. Each outpatient surgical hospital shall have a governing body or other legal authority responsible for the management and control of the operation of the facilities.

B. There shall be disclosure of hospital ownership. Ownership interest shall be made known to the OLC and in the case of corporations, all individuals or entities holding 5.0% or more of total ownership shall be identified by name and address. The OLC shall be notified of any changes in ownership.

C. The governing body shall provide facilities, personnel, and other resources necessary to meet patient and program needs.

D. The governing body shall have a formal organizational plan with written bylaws, rules and regulations or their equivalent. These shall clearly set forth organization, duties, responsibilities, accountability, and relationships of professional staff and other personnel. The person or organizational body responsible for formulating policies shall be identified.

E. The bylaws, rules and regulations, or their equivalent, shall include at least the following:

1. A statement of purpose;

2. Description of the functions and duties of the governing body, or other legal authority;

3. A statement of authority and responsibility delegated to the chief administrative officer and to the medical staff;

4. Provision for selection and appointment of medical staff and granting of clinical privileges:

5. Provision of guidelines for relationships among the governing body, the chief administrative officer, and the medical staff.

F. The responsibility for administration and management of the outpatient surgical hospital shall be vested in an individual whose qualifications, authority and duties shall be defined in a written statement adopted by the governing body.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 4.1, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 23, Issue 10, eff. March 1, 2007.

Article 2 Policies and Procedures

12VAC5-410-1160 General statement

Article 2 Policies and Procedures

Policies and procedures may vary depending on scope and type of service, personnel, equipment and location of the facility. It is recognized that no two facilities will be identical because of variations in the scope and objective of the outpatient service. Even though each facility may be different, certain standards and procedures shall be applicable to all in assuring the delivery of a high quality of care.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 4.2, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-1170 Policy and procedures manual

A. Each outpatient surgical hospital shall develop a policy and procedures manual that shall include provisions covering the following items:

1. The types of emergency and elective procedures that may be performed in the facility.

2. Types of anesthesia that may be used.

3. Admissions and discharges, including:

a. Criteria for evaluating the patient before admission and before discharge; and

b. Protocols to ensure that any patient scheduled to receive an elective surgical procedure for which the patient can reasonably be expected to require outpatient physical therapy as a follow-up treatment after discharge is informed that the patient:

(1) Is expected to require outpatient physical therapy as a follow-up treatment; and

(2) Will be required to select a physical therapy provider prior to being discharged from the hospital.

4. Written informed consent of patient prior to the initiation of any procedures.

5. Procedures for housekeeping and infection control and prevention.

6. Disaster preparedness.

7. Facility security.

B. Every outpatient surgical hospital where surgical procedures are performed shall adopt a policy requiring the use of a smoke evacuation system for all planned surgical procedures that are likely to generate surgical smoke.

C. An outpatient surgical hospital shall provide a copy of approved policies and procedures and any subsequent revisions to the OLC upon request.

D. Each outpatient surgical hospital shall establish a protocol relating to the rights and responsibilities of patients based on 42 CFR 416.50. The protocol shall include a process reasonably designed to inform patients of patient rights and responsibilities. Patients shall be given a copy of patient rights and responsibilities upon admission.

E. Each outpatient surgical hospital shall obtain a criminal history record check pursuant to § 32.1-126.02 of the Code of Virginia on any compensated employee not licensed by the Board of Pharmacy whose job duties provide access to controlled substances within the outpatient surgical hospital pharmacy.

F. During a declared public health emergency related to a communicable disease of public health threat, each hospital shall establish a protocol to allow patients to receive visits from a rabbi, priest, minister, or clergy member of a religious denomination or sect. Such protocol shall be consistent with guidance from the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services and subject to compliance with an executive order, order of public health, department guidance, or other applicable federal or state guidance having the effect of limiting visitation.

1. The protocol may restrict the frequency and duration of visits and may require visits to be conducted virtually using interactive audio or video technology.

2. The protocol may require the person visiting a patient pursuant to this subsection to comply with all reasonable requirements of the hospital adopted to protect the health and safety of the person, patients, and staff of the hospital.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 4.3, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 19, Issue 1, eff. November 1, 2002; Volume 23, Issue 10, eff. March 1, 2007; Volume 28, Issue 2, eff. November 1, 2011; Volume 36, Issue 23, eff. August 6, 2020; Volume 37, Issue 14, eff. March 31, 2021; Volume 42, Issue 1, eff. September 24, 2025; Volume 42, Issue 18, eff. June 4, 2026.

12VAC5-410-1171 Persons with a disability; designated support person in outpatient surgical hospitals

A. For the purposes of this section, "admission" means accepting a person for observation.

B. An outpatient surgical hospital shall allow a person with a disability who requires support and assistance necessary due to the specifics of the person's disability to be accompanied by a DSP who will provide support and assistance necessary due to the specifics of the person's disability to the person with a disability during an admission.

1. In any case in which the duration of the admission lasts more than 24 hours, the person with a disability may designate more than one DSP.

2. No outpatient surgical hospital shall be required to allow more than one DSP to be present with a person with a disability at any time.

C. An outpatient surgical hospital may:

1. Not subject a DSP to any restrictions on visitation;

2. Require a DSP to comply with all reasonable requirements of the outpatient surgical hospital adopted to protect the health and safety of the person with a disability, the DSP, the staff and other patients of or visitors to the outpatient surgical hospital, and the public; and

3. Restrict a DSP's access to specified areas of and movement on the premises of the outpatient surgical hospital when such restrictions are determined by the outpatient surgical hospital to be reasonably necessary to protect the health and safety of the person with a disability, the DSP, the staff and other patients of or visitors to an outpatient surgical hospital, and the public.

D. An outpatient surgical hospital may request that a person with a disability provide documentation indicating status as a person with a disability.

1. If the person with a disability fails, refuses, or is unable to provide documentation requested pursuant to this subsection, an outpatient surgical hospital may perform an objective assessment of the person to determine qualification as a person with a disability.

2. If an outpatient surgical hospital fails to perform an objective assessment pursuant to subdivision 1 of this subsection, an outpatient surgical hospital may not prohibit a DSP from accompanying a person with a disability for the purpose of providing support and assistance necessary due to the specifics of the person's disability.

E. An outpatient surgical hospital shall:

1. Establish protocols to inform patients, at the time of admission, of the right of a person with a disability who requires support and assistance necessary due to the specifics of the person's disability to be accompanied by a DSP for the purpose of providing support and assistance necessary due to the specifics of the person's disability;

2. Develop and make available to a patient or the patient's guardian, authorized representative, or care provider, upon request, written information regarding the right of a person with a disability who requires support and assistance necessary due to the specifics of the person's disability to be accompanied by a DSP and any policies related to that right; and

3. Make the written information described in subdivision 2 of this subsection available to the public on the hospital's website.

F. This section may not:

1. Alter the obligation of an outpatient surgical hospital to provide patients with effective communication support or other required services, regardless of the presence of a DSP or other reasonable accommodation, consistent with applicable federal or state law or regulations; or

2. Be interpreted to:

a. Prevent an outpatient surgical hospital from complying, interfere with the ability of the outpatient surgical hospital to comply with, or cause an outpatient surgical hospital to violate any federal or state law or regulation;

b. Deem a DSP to be acting under the direction or control of an outpatient surgical hospital or as an agent of an outpatient surgical hospital; or

c. Require an outpatient surgical hospital to allow a DSP to perform any action or provide any support or assistance necessary due to the specifics of the person's disability when the outpatient surgical hospital reasonably determines that the performance of the action or provision would be:

(1) Medically or therapeutically contraindicated; or

(2) A threat to the health and safety of the person with a disability, the DSP, or the staff or other patients of or visitors to the outpatient surgical hospital.

History

• Statutory Authority: §§ 32.1-12, 32.1-127, and 32.1-173.08 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 42, Issue 18, eff. June 4, 2026.

12VAC5-410-1175 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 32, Issue 14, eff. April 8, 2016; repealed, Virginia Register Volume 42, Issue 18, eff. June 4, 2026.

12VAC5-410-1176 Outpatient surgical hospitals; reports of threats or acts of violence against health care providers

A. For the purposes of this section:

"Employee of the hospital" or "employee" means an employee of the outpatient hospital or a health care provider credentialed by the outpatient hospital or engaged by the hospital to perform health care services on the premises of the outpatient hospital.

"Workplace violence" means any act of violence or threat of violence, without regard to the intent of the perpetrator, that occurs against an employee of the hospital while on the premises of such hospital and engaged in the performance of his duties. "Workplace violence" includes (i) the threat or use of physical force against an employee that results in, or has a high likelihood of resulting in, injury, psychological trauma, or stress, regardless of whether physical injury is sustained, and (ii) any incident involving the threat of using dangerous weapons or using common objects as weapons or to cause physical harm, regardless of whether physical injury is sustained.

B. An outpatient hospital shall:

1. Establish a workplace violence incident reporting system, through which the outpatient hospital shall document, track, and analyze any incident of workplace violence reported.

2. Use the results of the analysis to make improvements in preventing workplace violence, including improvements achieved through continuing education in targeted areas, including (i) de-escalation training, (ii) risk identification, and (iii) violence prevention planning.

3. Clearly communicate the reporting system to all employees, including to any new employees at the employee orientation. The reporting system shall include guidelines on when and how to report incidents of workplace violence to the employer, security agencies, and appropriate law-enforcement authorities;

4. Record all reported incidents of workplace violence as voluntarily reported by an employee; and

5. Adopt a policy that prohibits any person from discriminating or retaliating against any employee of the outpatient hospital for reporting to, or seeking assistance or intervention from, the employer, security agencies, law-enforcement authorities, local emergency services organizations, government agencies, or others participating in any incident investigation. The policy shall comply with the provisions of § 40.1-27.3 of the Code of Virginia.

C. An outpatient hospital shall maintain the record of reported incidents of workplace violence made pursuant to subsection B of this section for at least two years and shall include in the record, at a minimum:

1. The date and time of the incident;

2. A description of the incident, including the job title of the affected employee;

3. Whether the perpetrator was a patient, visitor, employee, or other person;

4. A description of where the incident occurred;

5. Information relating the type of incident, including whether the incident involved (i) a physical attack without a weapon; (ii) an attack with a weapon or object; (iii) a threat of physical force or use of a weapon or other object with the intent to cause bodily harm; (iv) sexual assault or the threat of sexual assault; or (v) anything else not listed in subdivisions (i) through (iv);

6. The response to and any consequences of the incident, including (i) whether security or law enforcement was contacted and, if so, their response and (ii) whether the incident resulted in any change to outpatient hospital policy; and

7. Information about the individual who completed the report, including the individual's name, job title, and the date of completion.

D. The outpatient hospital shall:

1. Report the data collected and reported pursuant to subsection C of this section to the chief medical officer and the chief nursing officer of the outpatient hospital on, at a minimum, a quarterly basis; and

2. Send a report to the Virginia Department of Health on an annual basis that includes, at a minimum, the number of incidents of workplace violence voluntarily reported by an employee pursuant to subsection B of this section. A report made to the Virginia Department of Health pursuant to this subsection shall be aggregated to remove any personally identifiable information.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 42, Issue 5, eff. November 19, 2025.

12VAC5-410-1178 Financial assistance in outpatient surgical hospitals

A. As used in this section, "patient" and "uninsured patient" have the same meanings as ascribed to these terms in § 32.1-137.010 A of the Code of Virginia.

B. An outpatient surgical hospital shall make reasonable efforts to screen every uninsured patient to determine whether the individual is eligible for medical assistance pursuant to the state plan for medical assistance or for financial assistance under the outpatient surgical hospital's financial assistance policy.

C. An outpatient surgical hospital shall inform every uninsured patient who receives services at the outpatient surgical hospital and who is determined to be eligible for assistance under the outpatient surgical hospital's financial assistance policy of the option to enter into a payment plan with the outpatient surgical hospital.

1. A payment plan entered into pursuant to this subsection shall be provided to the patient in writing or electronically and shall provide for repayment of the cumulative amount owed to the outpatient surgical hospital.

2. The amount of monthly payments and the term of the payment plan shall be determined based upon the patient's ability to pay.

3. Any interest on amounts owed pursuant to the payment plan shall not exceed the maximum judgment rate of interest pursuant to § 6.2-302 of the Code of Virginia.

4. The outpatient surgical hospital may not charge any fees related to the payment plan.

5. The payment plan shall allow prepayment of amounts owed without penalty.

D. An outpatient surgical hospital shall develop a process by which either an uninsured patient who agrees to a payment plan pursuant to subsection C of this section or the outpatient surgical hospital may request and shall be granted the opportunity to renegotiate the payment plan.

1. Renegotiation shall include opportunity for a new screening in accordance with subsection B of this section.

2. An outpatient surgical hospital may not charge any fees for renegotiation of a payment plan pursuant to this subsection.

E. An outpatient surgical hospital shall provide written information about:

1. The outpatient surgical hospital's charity care policies, including:

a. Policies related to free and discounted care;

b. Specific eligibility criteria for charity care; and

c. Procedures for applying for charity care;

2. The availability of a payment plan for the payment of debt owed to the outpatient surgical hospital pursuant to subsection C of this section; and

3. The renegotiation process described in subsection D of this section.

F. To provide the information required by subsection F of this section, an outpatient hospital shall:

1. Post the information conspicuously in public areas of the outpatient surgical hospital, including admissions or registration areas and associated waiting rooms;

2. Make the information available to:

a. A patient at the time of admission or discharge or at the time services are provided; and

b. Persons with limited English proficiency in accordance with the U.S. Department of Health and Human Services Guidance to Federal Financial Assistance Recipients Regarding Title VI Prohibition Against National Origin Discrimination Affecting Limited English Proficient Persons (August 8, 2003, 68 FR 47311), if the outpatient surgical hospital is subject to the requirements of Title VI of the Civil Rights Act of 1964 (Pub. L. No. 88-352), as amended; and

3. Include the information:

a. With any billing statements sent to uninsured patients; and

b. On any website maintained by the outpatient surgical hospital.

G. Notwithstanding any other provision of law, an outpatient surgical hospital may not engage in any action described in § 501(r)(6) of the Internal Revenue Code, as it was in effect on January 1, 2020, to recover a debt for medical services against any patient unless the outpatient surgical hospital has made all reasonable efforts to determine whether the patient:

1. Qualifies for medical assistance pursuant to the state plan for medical assistance; or

2. Is eligible for financial assistance under the outpatient surgical hospital's financial assistance policy.

H. Nothing in this section shall be construed to:

1. Prohibit an outpatient surgical hospital, as part of its financial assistance policy, from requiring a patient to:

a. Provide necessary information needed to determine eligibility for financial assistance under the outpatient surgical hospital's financial assistance policy, medical assistance pursuant to Title XVIII or XIX of the Social Security Act (42 USC § 301 et seq.) or 10 USC § 1071 et seq., or other programs of insurance; or

b. Undertake good faith efforts to apply for and enroll in the programs of insurance for which the patient may be eligible as a condition of awarding financial assistance;

2. Require an outpatient surgical hospital to grant or continue to grant any financial assistance or payment plan pursuant to this section when:

a. A patient has provided false, inaccurate, or incomplete information required for determining eligibility for the outpatient surgical hospital's financial assistance policy; or

b. A patient has not undertaken good faith efforts to comply with any payment plan pursuant to this section; or

3. Prohibit the coordination of benefits as required by state or federal law.

History

• Statutory Authority: §§ 32.1-12, 32.1-127, 32.1-137.01, and 32.1-137.010 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 42, Issue 18, eff. June 4, 2026.

Article 3 Staffing

12VAC5-410-1180 Medical staff

Article 3 Staffing

A. The size and organizational structure of the medical staff will vary depending on the scope of service.

1. Professional and clinical services shall be supervised by a physician licensed to practice medicine or surgery in Virginia.

2. Surgical procedures shall be performed by a physician licensed to perform such procedures in Virginia.

3. Clinical privileges of physician and nonphysician practitioners shall be clearly defined.

4. Credentials including education and experience shall be reviewed and privileges identified, established, and approved for each person allowed to diagnose, treat patients or perform surgical procedures in accordance with guidelines, policies or bylaws adopted by the governing body and approved by the medical staff.

B. No medication or treatment shall be given except on the signed order of a person lawfully authorized by state statute.

1. Outpatient surgical hospital personnel, as designated in medical staff bylaws, rules and regulations, or policies and procedures, may accept emergency telephone and other verbal orders for medication or treatment for outpatient surgical hospital patients from physicians and other persons lawfully authorized by state statute to give patient orders.

2. As specified in the hospital's medical staff bylaws, rules and regulations, or hospital policies and procedures, emergency telephone and other verbal orders shall be signed within a reasonable period of time not to exceed 72 hours by the person giving the order, or, when such person is not available, cosigned by another physician or other person authorized to give the order.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 4.4, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 19, Issue 1, eff. November 1, 2002.

12VAC5-410-1190 Nursing staff

A. The total number of nursing personnel will vary depending upon the number and types of patients to be admitted and the types of operative procedures to be performed or the services programmed.

1. A registered nurse qualified on the basis of education, experience, and clinical ability shall be responsible for the direction of nursing care provided the patients.

2. The number and type of nursing personnel, including registered nurses, licensed practical nurses, and supplementary staff, shall be based upon the needs of the patients and the types of services performed.

3. At least one registered nurse shall be on duty at all times while the facility is in use.

4. Job descriptions shall be developed for each level of nursing personnel and include functions, responsibilities, and qualifications.

5. Evidence of current Virginia registration required by state statute shall be on file in the facility.

B. Each outpatient surgical hospital shall quarterly report to the department no later 30 calendar days after January 1, April 1, July 1, and October 1:

1. The total number of certified sexual assault nurse examiners employed by the outpatient surgical hospital; and

2. The location, including street address, and contact information for each location at which the certified sexual assault nurse examiners provide services.

Each outpatient surgical hospital shall report the information required by this subsection to the Virginia Department of Health Office of Family Health Services.

History

• Statutory Authority: §§ 32.1-12, 32.1-23.2, and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 4.5, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 42, Issue 18, eff. June 4, 2026.

Article 4 Patient Care Services

12VAC5-410-1200 Anesthesia service

Article 4 Patient Care Services

A. The anesthesia service shall be directed by and under the supervision of a physician licensed to practice medicine or surgery in Virginia.

B. The physician responsible for the anesthesia service shall be present for the administration of anesthetics and recovery of patients when any general or major regional anesthetic is used.

C. There shall be written procedures to assure safety in storage and use of inhalation anesthetics and medical gases.

D. Unless the hospital program and official written action by the governing body prohibit use of flammable anesthetics, the requirements of 12VAC5-410-240 of this chapter must be met.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 4.6, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-1210 Sterile supply services

A. Adequate provisions shall be maintained for the processing, sterilizing, storing, and dispensing of clean and sterile supplies and equipment.

B. Written procedures shall be established for the appropriate disposal of pathological and other potentially infectious waste and contaminated supplies.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 4.7, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-1220 Dietary service

If the program calls for the dietary service, serving of snacks or other foods, adequate space, equipment, and supplies shall be provided. Applicable state and local codes pertaining to receiving, storage, refrigeration, preparation, and serving of food shall be followed.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 4.8, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-1230 Evacuation plan

A. Each outpatient surgical hospital shall develop a written evacuation plan to assure reasonable precautions are taken to protect patients, employees, and visitors from hazards of fire and other disaster. The evacuation plan shall provide:

B. A program to acquaint all personnel with evacuation procedures shall be maintained.

C. A copy of the plan and procedures shall be made available to the Office upon request.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 4.9, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-1240 Emergency services

A. Each outpatient surgical hospital shall provide emergency service and maintain on the premises adequate monitoring equipment, suction apparatus, oxygen, and related items necessary for resuscitation and control of hemorrhage and other complications.

B. A written agreement which ensures emergency transportation to a licensed general hospital shall be executed with an ambulance service.

C. A written agreement shall be executed with a general hospital to ensure that any patient of the outpatient surgical hospital shall receive needed emergency treatment. The agreement shall be within a licensed general hospital capable of providing full surgical, anesthesia, clinical laboratory, and diagnostic radiology service on 30 minutes notice and which has a physician in the hospital and available for emergency service at all times.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 4.10, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-1250 Laboratory and pathology services

A. Laboratory and pathology services each patient admitted to the outpatient surgical hospital shall receive appropriate laboratory testing according to 42 CFR Part 493.

B. All tissue removed shall be submitted for histological examination by a pathologist and a written report of his examination provided to the attending physician. The report of findings shall be filed in the patient's clinical record.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 4.11, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 22, Issue 8, eff. January 25, 2006.

12VAC5-410-1260 Medical records

A. An accurate and complete clinical record or chart shall be maintained on each patient. The record or chart shall contain sufficient information to satisfy the diagnosis or need for the medical or surgical service. It shall include, when applicable, the following:

1. Patient identification;

2. Admitting information, including patient history and physical examination;

3. Signed consent;

4. Confirmation of pregnancy;

5. Physician orders;

6. Laboratory tests, pathologist's report of tissue, and radiologist's report of x-rays;

7. Anesthesia record;

8. Operative record;

9. Surgical medication and medical treatments;

10. Recovery room notes;

11. Physician and nurse progress notes;

12. Condition at time of discharge;

13. Patient instructions, preoperative and postoperative; and

14. Names of referral physicians or agencies.

B. Provisions shall be made for the safe storage of medical records and the accurate and legible reproductions of medical records according to § 32.1-127.1:03 of the Code of Virginia and the Health Insurance Portability and Accountability Act ( (Pub. L. No. 104-191).

C. All medical records, either original or accurate reproductions, shall be preserved for a minimum of five years following discharge of the patient.

1. Records of minors shall be kept for at least five years after the minor has reached 18 years of age.

2. Birth and death information shall be retained for 10 years in accordance with § 32.1-274 of the Code of Virginia.

3. Record of abortions and proper information for the issuance of a fetal death certificate shall be furnished to the Office of Vital Records, Virginia Department of Health, as required by law.

D. An outpatient surgical hospital that makes health records, as defined in § 32.1-127.1:03 of the Code of Virginia, of patients who are minors available to patients through a secure website shall make the health records available to the patient's parent or guardian through the secure website, unless the hospital cannot make the health record available:

1. In a manner that prevents disclosure of information, the disclosure of which has been denied pursuant to § 32.1-127.1:03 F of the Code of Virginia; or

2. Because the consent required in accordance with § 54.1-2969 E of the Code of Virginia has not been provided.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 4.12, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 22, Issue 8, eff. January 25, 2006; Volume 42, Issue 18, eff. June 4, 2026.

12VAC5-410-1270 Preoperative admission

A. Prior to the initiation of any procedure, a medical history and physical examination shall be completed for each patient.

B. Where medical evaluation, examination, and referrals are made from a private physician's office, another hospital, clinic, or medical service pertinent available records thereof shall be made and included as a part of the patient's medical record at the time the patient is admitted to the outpatient surgical hospital.

C. Sufficient time shall be allowed between initial examination and initiation of any procedure to permit the reporting and review of laboratory tests by the responsible physician.

D. In outpatient surgical hospitals which provide abortion services, the diagnosis of pregnancy shall be the responsibility of the physician performing the abortion procedure.

E. Outpatient surgical hospitals which provide abortion services shall offer each patient appropriate counseling and instruction in the abortion procedure and in birth control methods.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 4.13, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-1280 Post-operative recovery

A. Each patient shall be observed for post-operative complications under the direct supervision of a registered professional nurse. Recovery room nurses shall have specialized training in resuscitation techniques and other emergency procedures consistent with policies and procedures of the institution for designated special units.

B. A physician licensed in Virginia shall be present on the premises at all times during the operative and post-operative period until discharge of the patient.

C. Patients shall be discharged from the recovery only on written order of the attending physician.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 4.14, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-1290 Environment and maintenance

A. All parts of the outpatient surgical hospital and its premises shall be kept clean, neat, and free of litter and rubbish.

B. Hazardous cleaning solutions, compounds, and substances shall be labeled, stored in a safe place, and kept in an enclosed section separate from other materials.

C. Accumulated waste, including all contaminated sharps, dressings, or similar infectious waste, shall be disposed of in a manner compliant with the OSHA Bloodborne Pathogens standard (29 CFR 1910.1030).

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 4.15, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 22, Issue 8, eff. January 25, 2006.

12VAC5-410-1300 Laundry services

A. Each outpatient surgical hospital shall make provisions for the cleaning of all linens.

B. There shall be distinct areas for the separate storage and handling of clean and soiled linens.

C. All soiled linen shall be placed in closed containers prior to transportation.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 4.16, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995.

12VAC5-410-1310 (Repealed.)

Historical Notes

Derived from VR355-33-500 § 4.17, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; repealed, Virginia Register Volume 22, Issue 8, eff. January 25, 2006.

12VAC5-410-1320 (Repealed.)

Historical Notes

Derived from VR355-33-500 §§ 5.1-5.3, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; repealed, Virginia Register Volume 22, Issue 8, eff. January 25, 2006.

Article 1 General Considerations

12VAC5-410-1350 Local and state codes and standards

A. All construction of new buildings and additions, renovations, or alterations to existing buildings for occupancy as a "free-standing" outpatient hospital shall conform to state and local codes, zoning ordinances, and the Virginia Uniform Statewide Building Code (13VAC5-63).

In addition, hospitals shall be designed and constructed consistent with Part 1 and Chapters 2.1 and 2.7 of Part 2 of the Guidelines for Design and Construction of Outpatient Facilities, 2022 Edition (The Facility Guidelines Institute ), as amended by the January 2025 Errata for the Guidelines for Design and Construction of Outpatient Facilities, 2022 Edition (The Facility Guidelines Institute).

Architectural drawings and specifications for all new construction or for additions, alterations, or renovations to any existing building shall be dated, stamped with professional seal, and signed by the architect. The architect shall certify that the drawings and specifications were prepared to conform to the Virginia Uniform Statewide Building Code (13VAC5-63) and be consistent with Part 1 and Chapters 2.1 and 2.7 of Part 2 of the Guidelines for Design and Construction of Outpatient Facilities, 2022 Edition (The Facility Guidelines Institute), as amended by the January 2025 Errata for the Guidelines for Design and Construction of Outpatient Facilities, 2022 Edition (The Facility Guidelines Institute).

B. The use of an incinerator shall require permitting from the nearest regional office of the Department of Environmental Quality.

C. Water shall be obtained from an approved water supply system. Outpatient surgery centers shall be connected to sewage systems approved by the Department of Health or the Department of Environmental Quality.

D. Each outpatient surgery center shall establish a monitoring program for the internal enforcement of all applicable fire and safety laws and regulations.

E. All radiological machines shall be registered with the Office of Radiological Health of the Virginia Department of Health. Installation, calibration and testing of machines and storage facilities shall comply with the Virginia Radiation Protection Regulations (12VAC5-481).

F. Pharmacy services shall comply with Chapter 33 (§ 54.1-3300 et seq.) of Title 54.1 of the Code of Virginia and Regulations Governing the Practice of Pharmacy (18VAC110-20).

History

• Statutory Authority: §§ 32.1-12, 32.1-127, and 32.1-127.001 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 5.4, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 22, Issue 8, eff. January 25, 2006; Volume 23, Issue 10, eff. March 1, 2007; Volume 26, Issue 22, eff. August 4, 2010; Volume 37, Issue 19, eff. June 9, 2021; Volume 42, Issue 18, eff. June 4, 2026.

12VAC5-410-1360 (Repealed.)

Historical Notes

Derived from VR355-33-500 § 5.5, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; repealed, Virginia Register Volume 22, Issue 8, eff. January 25, 2006.

Article 2 Architectural Plan Review

12VAC5-410-1370 (Repealed.)

Historical Notes

Derived from VR355-33-500 § 5.6, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; repealed, Virginia Register Volume 22, Issue 8, eff. January 25, 2006.

12VAC5-410-1380 Drawings and specifications

A. All new construction or for additions, alterations or renovations to any existing building shall be dated, stamped with licensure seal and signed by the architect. The architect shall certify that the drawings and specifications were prepared to conform to building code requirements. The certification shall be forwarded to the OLC.

B. Additional approval may include a Certificate of Public Need.

C. Upon completion of the construction, the outpatient surgery center shall maintain a complete set of legible "as is" drawings showing all construction, fixed equipment, and mechanical and electrical systems, as installed or built.

History

• Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.
• Historical Notes: Derived from VR355-33-500 § 5.7, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 22, Issue 8, eff. January 25, 2006; Volume 23, Issue 10, eff. March 1, 2007.

12VAC5-410-1390 (Repealed.)

Historical Notes

Derived from VR355-33-500 §§ 5.8-5.11, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; repealed, Virginia Register Volume 22, Issue 8, eff. January 25, 2006.

Chapter 421 Food Regulations

Part I Definitions, Purpose, and Administration

12VAC5-421-10 Definitions

A. Section 35.1-1 of the Code of Virginia provides definitions of the following terms and phrases as used in this chapter.

"Board"

"Commissioner"

"Department"

B. For the purposes of implementing this chapter, the term "food establishment" as defined in this section is equivalent to the term "restaurant" as defined in § 35.1-1 of the Code of Virginia.

C. The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise.

"Accredited program" means a food protection manager certification program that has been evaluated and listed by an accrediting agency as conforming to national standards that certify individuals. "Accredited program" refers to the certification process and is a designation based upon an independent evaluation of factors such as the sponsor's mission; organizational structure; staff resources; revenue sources; policies; public information regarding program scope, eligibility requirements, recertification, discipline and grievance procedures; and test development and administration. "Accredited program" does not refer to training functions or educational programs.

"Additive" means either a (i) "food additive" having the meaning stated in the Federal Food, Drug, and Cosmetic Act, § 201(s) and 21 CFR 170.3(e)(1) or (ii) "color additive" having the meaning stated in the Federal Food, Drug, and Cosmetic Act, § 201(t) and 21 CFR 70.3(f).

"Adulterated" has the meaning stated in the Federal Food, Drug, and Cosmetic Act, § 402.

"Agent" means a legally authorized representative of the owner.

"Approved" means acceptable to the department based on a determination of conformity with principles, practices, and generally recognized standards that protect public health.

"Approved water system" means a permitted waterworks constructed, maintained, and operated pursuant to 12VAC5-590, Waterworks Regulations; or a private well constructed, maintained, and operated pursuant to 12VAC5-630, Private Well Regulations.

"Asymptomatic" means without obvious symptoms; not showing or producing indications of a disease or other medical condition, such as an individual infected with a pathogen but not exhibiting or producing any signs or symptoms of vomiting, diarrhea, or jaundice. Asymptomatic includes not showing symptoms because symptoms have resolved or subsided, or because symptoms never manifested.

"a_w" means water activity that is a measure of the free moisture in a food, is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature, and is indicated by the symbol a_w.

"Balut" means an embryo inside a fertile egg that has been incubated for a period sufficient for the embryo to reach a specific stage of development after which it is removed from incubation before hatching.

"Bed and breakfast operation" means a residential-type establishment that provides (i) two or more rental accommodations for transient guests and food service to a maximum of 18 transient guests on any single day for five or more days in any calendar year or (ii) at least one rental accommodation for transient guests and food service to a maximum of 18 transient guests on any single day for 30 or more days in any calendar year.

"Beverage" means a liquid for drinking, including water.

"Bottled drinking water" means water that is sealed in bottles, packages, or other containers and offered for sale for human consumption, including bottled mineral water.

"Building official" means a representative of the Department of Housing and Community Development.

"Casing" means a tubular container for sausage products made of either natural or artificial (synthetic) material.

"Catering operation" means a person who contracts with a client to prepare a specific menu and amount of food in a permitted food establishment for service to the client's guests or customers at a service location different from the permitted food establishment. Catering may also include cooking or performing final preparation of food at the service location.

"Catering operation" does not include:

1. A private chef or cook who, as the employee of a consumer, prepares food solely in the consumer's home.

2. Delivery service of food by an approved and permitted food establishment to an end consumer.

"Certification number" means the unique identification number issued by the shellfish control authority to each dealer for each location. Each certification number shall consist of a one-to-five-digit Arabic number preceded by the two-letter State abbreviation and followed by a two-letter abbreviation for the type of activities the dealer is qualified to perform in accordance with the provisions of the National Shellfish Sanitation Program.

| Table A. Certifications | | | --- | --- | | Acronym | Term | | SP | Shucker Packer | | RP | Repacker | | SS | Shellstock Shipper | | RS | Reshipper | | DP | Depuration |

| Table B. Permits | | | --- | --- | | Acronym | Term | | PHP | Post-Harvest Processing | | AQ | Aquaculture | | WS | Wet Storage |

"CFR" means Code of Federal Regulations. Citations in this chapter to the CFR refer sequentially to the title, part, and section number, such as 40 CFR 180.194 refers to Title 40, Part 180, Section 194.

"Clean in Place" or "CIP" means cleaned in place by the circulation or flowing by mechanical means through a piping system of a detergent solution, water rinse, and sanitizing solution onto or over equipment surfaces that require cleaning, such as the method used, in part, to clean and sanitize a frozen dessert machine. "CIP" does not include the cleaning of equipment such as band saws, slicers or mixers that are subjected to in-place manual cleaning without the use of a CIP system.

"Commingle" means the act of combining different lots of shellfish.

"Comminuted" means reduced in size by methods including chopping, flaking, grinding, or mincing. "Comminuted" includes (i) fish or meat products that are reduced in size and restructured or reformulated such as gefilte fish, gyros, ground beef, and sausage and (ii) a mixture of two or more types of meat that have been reduced in size and combined, such as sausages made from two or more meats.

"Commissary" means a food establishment in which food, food containers, or supplies are kept, handled, prepared, packaged, or stored for distribution to satellite operations.

"Commonwealth" means the Commonwealth of Virginia.

"Conditional employee" means a potential food employee to whom a job offer is made, conditional on responses to subsequent medical questions or examinations designed to identify potential food employees who may be suffering from a disease that can be transmitted through food and done in compliance with Title 1 of the Americans with Disabilities Act of 1990.

"Confirmed disease outbreak" means a foodborne disease outbreak in which laboratory analysis of appropriate specimens identifies a causative agent and epidemiological analysis implicates the food as the source of the illness.

"Consumer" means a person who is a member of the public, takes possession of food, is not functioning in the capacity of an operator of a food establishment or food processing plant, and does not offer the food for resale.

"Core item" means a provision in this chapter that is not designated as a priority item or a priority foundation item. Core item includes an item that usually relates to general sanitation, operational controls, sanitation standard operating procedures (SSOPs), facilities or structures, equipment design, or general maintenance.

"Corrosion-resistant materials" means a material that maintains acceptable surface cleanability characteristics under prolonged influence of the food to be contacted, the normal use of cleaning compounds and sanitizing solutions, and other conditions of the use environment.

"Counter-mounted equipment" means equipment that is not portable and is designed to be mounted off the floor on a table, counter, or shelf.

"Critical control point" means a point or procedure in a specific food system where loss of control may result in an unacceptable health risk.

"Critical limit" means the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to minimize the risk that the identified food safety hazard may occur.

"Cut leafy greens" means fresh leafy greens whose leaves have been cut, shredded, sliced, chopped, or torn. The term "leafy greens" includes iceberg lettuce, romaine lettuce, leaf lettuce, butter lettuce, baby leaf lettuce (i.e., immature lettuce or leafy greens), escarole, endive, spring mix, spinach, cabbage, kale, arugula, and chard. The term "leafy greens" does not include herbs such as cilantro or parsley.

"Dealer" means a person who is authorized by a shellfish control authority for the activities of a shellstock shipper, shucker-packer, repacker, reshipper, or depuration processor of molluscan shellfish according to the provisions of the National Shellfish Sanitation Program and is listed in the U.S. Food and Drug Administration's Interstate Certified Shellfish Shippers List, updated monthly (U.S. Food and Drug Administration).

"Director" means the district or local health director.

"Disclosure" means a written statement that clearly identifies the animal derived foods that are, or can be ordered, raw, undercooked, or without otherwise being processed to eliminate pathogens, or items that contain an ingredient that is raw, undercooked, or without otherwise being processed to eliminate pathogens.

"Dry storage area" means a room or area designated for the storage of packaged or containerized bulk food that is not time/temperature control for safety food and dry goods such as single-service items.

"Easily cleanable" means a characteristic of a surface that:

1. Allows effective removal of soil by normal cleaning methods;

2. Is dependent on the material, design, construction, and installation of the surface; and

3. Varies with the likelihood of the surface's role in introducing pathogenic or toxigenic agents or other contaminants into food based on the surface's approved placement, purpose, and use.

"Easily cleanable" includes a tiered application of the criteria that qualify the surface as easily cleanable as specified in this definition to different situations in which varying degrees of cleanability are required such as:

1. The appropriateness of stainless steel for a food preparation surface as opposed to the lack of need for stainless steel to be used for floors or for tables used for consumer dining; or

2. The need for a different degree of cleanability for a utilitarian attachment or accessory in the kitchen as opposed to a decorative attachment or accessory in the consumer dining area.

"Easily movable" means:

1. Portable; mounted on casters, gliders, or rollers; or provided with a mechanical means to safely tilt a unit of equipment for cleaning; and

2. Having no utility connection, a utility connection that disconnects quickly, or a flexible utility connection line of sufficient length to allow the equipment to be moved for cleaning of the equipment and adjacent area.

"Egg" means the shell egg of avian species such as chicken, duck, goose, guinea, quail, ratites, or turkey. Egg does not include a balut; egg of the reptile species such as alligator; or an egg product.

"Egg product" means all, or a portion of, the contents found inside eggs separated from the shell and pasteurized in a food processing plant, with or without added ingredients, intended for human consumption, such as dried, frozen, or liquid eggs. Egg product does not include food that contains eggs only in a relatively small proportion such as cake mixes.

"Employee" means the permit holder, person in charge, food employee, person having supervisory or management duties, person on the payroll, family member, volunteer, person performing work under contractual agreement, or other person working in a food establishment.

"EPA" means the U.S. Environmental Protection Agency.

"Equipment" means an article that is used in the operation of a food establishment. "Equipment" includes items such as a freezer, grinder, hood, ice maker, meat block, mixer, oven, reach-in refrigerator, scale, sink, slicer, stove, table, temperature measuring device for ambient air, vending machine, or warewashing machine. Equipment does not include apparatuses used for handling or storing large quantities of packaged foods that are received from a supplier in a cased or overwrapped lot, such as hand trucks, forklifts, dollies, pallets, racks, and skids.

"Exclude" means to prevent a person from working as an employee in a food establishment or entering a food establishment as an employee.

"FDA" means the U.S. Food and Drug Administration.

"Fish" means fresh or saltwater finfish, crustaceans, and other forms of aquatic life (including alligator, frog, aquatic turtle, jellyfish, sea cucumber, and sea urchin and the roe of such animals) other than birds or mammals, and all mollusks, if such animal life is intended for human consumption and includes an edible human food product derived in whole or in part from fish, including fish that has been processed in any manner.

"Food" means (i) a raw, cooked, or processed edible substance, ice, beverage, or ingredient used or intended for use or for sale in whole or in part for human consumption or (ii) chewing gum.

"Foodborne disease outbreak" means the occurrence of two or more cases of a similar illness resulting from the ingestion of a common food.

"Food-contact surface" means a surface of equipment or a utensil with which food normally comes into contact, or a surface of equipment or a utensil from which food may drain, drip, or splash into a food, or onto a surface normally in contact with food.

"Food employee" means an individual working with unpackaged food, food equipment or utensils, or food-contact surfaces.

"Food establishment" means an operation that (i) stores, prepares, packages, serves, vends food directly to the consumer, or otherwise provides food to the public for human consumption, such as a restaurant, satellite or catered feeding location, catering operation if the operation provides food directly to a consumer or to a conveyance used to transport people, market, vending location, conveyance used to transport people, institution, or food bank, and (ii) relinquishes possession of food to a consumer directly or indirectly through a delivery service, such as home delivery of grocery orders or restaurant takeout orders, or delivery service that is provided by common carriers.

"Food establishment" includes (i) an element of the operation such as a transportation vehicle or a central preparation facility that supplies a vending location or satellite feeding location unless the vending or feeding location is permitted under this chapter; and (ii) an operation that is conducted in a mobile, stationary, temporary, or permanent facility or location where consumption is on or off the premises and regardless of whether there is a charge for the food.

"Food establishment" does not include:

1. An establishment that offers only prepackaged food that is not time/temperature control for safety food;

2. A produce stand that only offers whole, uncut fresh fruits and vegetables; or

3. A food processing plant, including those that are located on the premises of a food establishment.

"Food processing plant" means a commercial operation that manufactures, packages, labels, or stores food for human consumption and provides food for sale or distribution to other business entities such as food processing plants or food establishments. Food processing plant does not include a food establishment.

"Game animal" means an animal, the products of which are food, that is not classified as (i) livestock, sheep, swine, goat, horse, mule, or other equine in 9 CFR 301.2; (ii) poultry; or (iii) fish. "Game animal" includes mammals such as reindeer, elk, deer, antelope, water buffalo, bison, rabbit, squirrel, opossum, raccoon, nutria, or muskrat and nonaquatic reptiles such as land snakes. "Game animal" does not include ratites.

"General use pesticide" means a pesticide that is not classified by EPA for restricted use as specified in 40 CFR 152.175.

"Grade A standards" means the requirements of the Grade "A" Pasteurized Milk Ordinance, 2017 Revision (U.S. Food and Drug Administration), with which certain fluid and dry milk and milk products comply.

"Handwashing sink" means a lavatory, a basin or vessel for washing, a wash basin, or a plumbing fixture especially placed for use in personal hygiene and designed for the washing of hands. Handwashing sink includes an automatic handwashing facility.

"Hazard" means a biological, chemical, or physical property that may cause an unacceptable consumer health risk.

"Hazard Analysis and Critical Control Point" or "HACCP plan" means a written document that delineates the formal procedures for following the Hazard Analysis and Critical Control Point principles developed by The National Advisory Committee on Microbiological Criteria for Foods.

"Health practitioner" means a physician licensed to practice medicine, or if allowed by law, a nurse practitioner, physician assistant, or similar medical professional.

"Hermetically sealed container" means a container that is designed and intended to be secure against the entry of microorganisms and, in the case of low acid canned foods, to maintain the commercial sterility of its contents after processing.

"Highly susceptible population" means persons who are more likely than other people in the general population to experience foodborne disease because they are:

1. Immunocompromised, preschool age children, or older adults; and

2. Obtaining food at a facility that provides services such as custodial care, health care, or assisted living, such as a child or adult day care center, kidney dialysis center, hospital or nursing home, or nutritional or socialization services such as a senior center.

"Imminent health hazard" means a significant threat or danger to health that is considered to exist when there is evidence sufficient to show that a product, practice, circumstance, or event creates a situation that requires immediate correction or cessation of operation to prevent injury based on the number of potential injuries, and the nature, severity, and duration of the anticipated injury.

"Injected" means manipulating meat to which a solution has been introduced into its interior by processes that are referred to as "injecting," "pump marinating," or "stitch pumping."

"In-shell product" means non-living, processed shellfish with one or both shells present.

"Intact meat" means a cut of whole-muscle meat that has not undergone comminution, injection, mechanical tenderization, vacuum tumbling with solutions, reconstruction, cubing, or pounding.

"Juice" means the aqueous liquid expressed or extracted from one or more fruits or vegetables, purées of the edible portions of one or more fruits or vegetables, or any concentrate of such liquid or purée. Juice does not include, for purposes of HACCP, liquids, purées, or concentrates that are not used as beverages or ingredients of beverages.

"Kitchenware" means food preparation and storage utensils.

"Law" means applicable local, state, and federal statutes, regulations, and ordinances.

"Linens" means fabric items such as cloth hampers, cloth napkins, table cloths, wiping cloths, and work garments including cloth gloves.

"Major food allergen" means milk, egg, fish (such as bass, flounder, cod, and including crustacean shellfish such as crab, lobster, or shrimp), tree nuts (such as almonds, pecans, or walnuts), wheat, peanuts, soybeans, and sesame; or a food ingredient that contains protein derived from one of these foods. Major food allergen does not include any highly refined oil derived from a major food allergen in this definition and any ingredient derived from such highly refined oil or any ingredient that is exempt under the petition or notification process specified in the Food Allergen Labeling and Consumer Protection Act of 2004 (P.L. 108-282).

"Meat" means the flesh of animals used as food including the dressed flesh of cattle, swine, sheep, or goats and other edible animals, except fish, poultry, and wild game animals as specified under 12VAC5-421-330 A 2 and A 3.

"Mechanically tenderized" means manipulating meat by piercing with a set of needles, pins, blades, or any mechanical device that breaks up muscle fiber and tough connective tissue to increase tenderness. This includes injection, scoring, and processes that may be referred to as "blade tenderizing," "jaccarding," "pinning," or "needling".

"mg/L" means milligrams per liter, which is the metric equivalent of parts per million (ppm).

"Mobile food unit" means a food establishment mounted on wheels (excluding boats in the water) readily moveable from place to place at all times during operation and shall include pushcarts, trailers, trucks, or vans. The unit, all operations, and all equipment must be integral to and be within or attached to the unit.

"Molluscan shellfish" means any edible species of fresh or frozen oysters, clams, mussels, and scallops or edible portions thereof, except when the scallop product consists only of the shucked adductor muscle. Molluscan shellfish includes shellstock, shucked shellfish, and in-shell products.

"Noncontinuous cooking" means the cooking of food in a food establishment using a process in which the initial heating of the food is intentionally halted so that it may be cooled and held for complete cooking at a later time prior to sale or service. "Noncontinuous cooking" does not include cooking procedures that only involve temporarily interrupting or slowing an otherwise continuous cooking process.

"Occasional" means not more than one time per week, and not in excess of two days duration.

"Packaged" means bottled, canned, cartoned, bagged, or wrapped, whether packaged in a food establishment or a food processing plant. Packaged does not include wrapped or placed in a carry-out container to protect the food during service or delivery to the consumer, by a food employee, upon consumer request.

"Permit" means a license issued by the department that authorizes a person to operate a food establishment.

"Permit holder" means person that is legally responsible for the operation of the food establishment and possesses a valid permit to operate a food establishment.

"Person" means an association, a corporation, individual, partnership, other legal entity, government, or governmental subdivision or agency.

"Person in charge" means the individual present at a food establishment who is responsible for the operation at the time of inspection.

"Personal care items" means items or substances that may be poisonous, toxic, or a source of contamination and are used to maintain or enhance a person's health, hygiene, or appearance. Personal care items include items such as medicines; first aid supplies; and other items such as cosmetics, and toiletries such as toothpaste and mouthwash.

"pH" means the symbol for the negative logarithm of the hydrogen ion concentration, which is a measure of the degree of acidity or alkalinity of a solution. Values between 0 and 7 indicate acidity and values between 7 and 14 indicate alkalinity. The value for pure distilled water is 7, which is considered neutral.

"Physical facilities" means the structure and interior surfaces of a food establishment including accessories such as soap and towel dispensers and attachments such as light fixtures and heating or air conditioning system vents.

"Plumbing fixture" means a receptacle or device that is permanently or temporarily connected to the water distribution system of the premises and demands a supply of water from the system or discharges used water, waste materials, or sewage directly or indirectly to the drainage system of the premises.

"Plumbing system" means the water supply and distribution pipes; plumbing fixtures and traps; soil, waste, and vent pipes; sanitary and storm sewers and building drains, including their respective connections, devices, and appurtenances within the premises; and water-treating equipment.

"Poisonous or toxic materials" means substances that are not intended for ingestion and are included in five categories:

1. Cleaners and sanitizers, that include cleaning and sanitizing agents and agents such as caustics, acids, drying agents, polishes, and other chemicals;

2. Pesticides, except sanitizers, that include substances such as insecticides and rodenticides;

3. Substances necessary for the operation and maintenance of the establishment such as nonfood grade lubricants, paints, and personal care items that may be deleterious to health;

4. Substances that are not necessary for the operation and maintenance of the establishment and are on the premises for retail sale, such as petroleum products and paints; and

5. Restricted use pesticides.

"Potable water" means water fit for human consumption that is obtained from an approved water supply and that is (i) sanitary and normally free of minerals, organic substances, and toxic agents in excess of reasonable amounts and (ii) adequate in quantity and quality for the minimum health requirements of the persons served (see Article 2 (§ 32.1-167 et seq.) of Chapter 6 of Title 32.1 of the Code of Virginia). Potable water is traditionally known as drinking water and excludes such nonpotable forms as "boiler water, "mop water," "rainwater," "wastewater," and "nondrinking water."

"Poultry" means any domesticated bird (chickens, turkeys, ducks, geese, guineas, ratites, or squabs), whether live or dead, as defined in 9 CFR 381.1, and any migratory waterfowl, game bird, pheasant, partridge, quail, grouse, or pigeon whether live or dead, as defined in 9 CFR 362.1.

"Premises" means the physical facility, its contents, and the contiguous land or property under the control of the permit holder; or the physical facility, its contents, and the land or property which are under the control of the permit holder and may impact food establishment personnel, facilities, or operations, if a food establishment is only one component of a larger operation such as a health care facility, hotel, motel, school, recreational camp, or prison.

"Primal cut" means a basic major cut into which carcasses and sides of meat are separated, such as a beef round, pork loin, lamb flank, or veal breast.

"Priority foundation item" means a provision in this chapter whose application supports, facilitates, or enables one or more priority items. "Priority foundation item" includes an item that requires the purposeful incorporation of specific actions, equipment, or procedures by industry management to attain control of risk factors that contribute to foodborne illness or injury such as personnel training, infrastructure or necessary equipment, HACCP plans, documentation or record keeping, and labeling and is denoted in this regulation with a superscript Pf-^Pf.

"Priority item" means a provision in this chapter whose application contributes directly to the elimination, prevention or reduction to an acceptable level, hazards associated with foodborne illness or injury and there is no other provision that more directly controls the hazard. "Priority item" includes items with a quantifiable measure to show control of hazards such as cooking, reheating, cooling, and handwashing and is denoted in this chapter with a superscript P-^p.

"Private well" means any water well constructed for a person on land that is owned or leased by that person and is usually intended for household, groundwater source heat pump, agricultural use, industrial use, or other nonpublic water well.

"Pure water" means potable water fit for human consumption that is (i) sanitary and normally free of minerals, organic substances, and toxic agents in excess of reasonable amounts and (ii) adequate in quantity and quality for the minimum health requirements of the persons served (see §§ 32.1-167 and 32.1-176.1 of the Code of Virginia and 12VAC5-590, Waterworks Regulations and 12VAC5-630, Private Well Regulations. Potable water is traditionally known as drinking water, and excludes such nonpotable forms as "boiler water," "mop water," "rainwater," "wastewater," and "nondrinking water."

"Ratite" means a flightless bird such as an emu, ostrich, or rhea.

"Ready-to-eat food" means food that:

1. Is in a form that is edible without additional preparation to achieve food safety, as specified under 12VAC5-421-700 A, B, and C, 12VAC5-421-710, or 12VAC5-421-730;

2. Is a raw or partially cooked animal food and the consumer is advised as specified under 12VAC5-421-700 D 1 and D 3; or

3. Is prepared in accordance with a variance that is granted as specified under 12VAC5-421-700 D 4.

"Ready-to-eat food" may receive additional preparation for palatability or aesthetic, epicurean, gastronomic, or culinary purposes.

"Ready-to-eat food" includes:

1. Raw animal food that is cooked as specified under 12VAC5-421-700 or 12VAC5-421-710, or frozen as specified under 12VAC5-421-730;

2. Raw fruits and vegetables that are washed as specified under 12VAC5-421-510;

3. Plant foods that are cooked for hot holding as specified under 12VAC5-421-720;

4. All time/temperature control for safety food that is cooked to the temperature and time required for the specific food under Article 4 (12VAC5-421-700 et seq.) of Part III and cooled as specified in 12VAC5-421-800;

5. Plant food for which further washing, cooking, or other processing is not required for food safety, and from which rinds, peels, husks, or shells, if naturally present, are removed;

6. Substances derived from plants such as spices, seasonings, and sugar;

7. A bakery item such as bread, cakes, pies, fillings, or icing for which further cooking is not required for food safety;

8. The following products that are produced in accordance with USDA guidelines and that have received a lethality treatment for pathogens: dry, fermented sausages, such as dry salami or pepperoni; salt-cured meat and poultry products, such as prosciutto ham, country cured ham, and Parma ham; and dried meat and poultry products, such as jerky or beef sticks; and

9. Food manufactured as specified in 21 CFR Part 113.

"Ready-to-eat food" does not include:

1. Commercially packaged food that bears a manufacturer's cooking instructions; or

2. Food for which the manufacturer has provided information that it has not been processed to control pathogens.

"Reduced oxygen packaging" means the reduction of the amount of oxygen in a package by removing oxygen; displacing oxygen and replacing it with another gas or combination of gases; or otherwise controlling the oxygen content to a level below that normally found in the atmosphere (approximately 21% at sea level); and a process as specified in this definition that involves a food for which the hazards Clostridium botulinum or Listeria monocytogenes require control in the final packaged form. Reduced oxygen packaging includes:

1. Vacuum packaging, in which air is removed from a package of food and the package is hermetically sealed so that a vacuum remains inside the package;

2. Modified atmosphere packaging, in which the atmosphere of a package of food is modified so that its composition is different from air, but the atmosphere may change over time due to the permeability of the packaging material or the respiration of the food. Modified atmosphere packaging includes reduction in the proportion of oxygen, total replacement of oxygen, or an increase in the proportion of other gases such as carbon dioxide or nitrogen;

3. Controlled atmosphere packaging, in which the atmosphere of a package of food is modified so that until the package is opened, its composition is different from air, and continuous control of that atmosphere is maintained, such as by using oxygen scavengers or a combination of total replacement of oxygen, nonrespiring food, and impermeable packaging material;

4. Cook chill packaging, in which cooked food is hot filled into impermeable bags that are then sealed or crimped closed. The bagged food is rapidly chilled and refrigerated at temperatures that inhibit the growth of psychotrophic pathogens; or

5. Sous vide packaging, in which raw or partially cooked food is vacuum packaged in an impermeable bag, cooked in the bag, rapidly chilled, and refrigerated at temperatures that inhibit the growth of psychotropic pathogens.

"Refuse" means solid waste not carried by water through a sewage system.

"Regulatory authority" means the local, state, or federal enforcement body or authorized representative having jurisdiction over the food establishment.

"Reminder" means a written statement concerning the health risk of consuming animal foods raw, undercooked, or without otherwise being processed to eliminate pathogens.

"Re-service" means the transfer of food that is unused and returned by a consumer after being served or sold and in the possession of the consumer, to another person.

"Restrict" means to limit the activities of a food employee so that there is no risk of transmitting a disease that is transmissible through food and the food employee does not work with exposed food, clean equipment, utensils, linens, or unwrapped single-service or single-use articles.

"Restricted egg" means any check, dirty egg, incubator reject, inedible, leaker, or loss as defined in 9 CFR Part 590.

"Restricted use pesticide" means a pesticide product that contains the active ingredients specified in 40 CFR 152.175 and that is limited to use by or under the direct supervision of a certified applicator.

"Risk" means the likelihood that an adverse health effect will occur within a population as a result of a hazard in a food.

"Safe material" means an article manufactured from or composed of materials that may not reasonably be expected to result, directly or indirectly, in their becoming a component or otherwise affecting the characteristics of any food; an additive that is used as specified in § 409 of the Federal Food, Drug, and Cosmetic Act (21 USC § 348); or other materials that are not additives and that are used in conformity with applicable regulations of the FDA.

"Sanitization" means the application of cumulative heat or chemicals on cleaned food-contact surfaces that, when evaluated for efficacy, is sufficient to yield a reduction of five logs, which is equal to a 99.999% reduction, of representative disease microorganisms of public health importance.

"Sealed" means free of cracks or other openings that allow the entry or passage of moisture.

"Service animal" means an animal such as a guide dog, signal dog, or other animal individually trained to provide assistance to an individual with a disability.

"Servicing area" means an operating base location to which a mobile food establishment or transportation vehicle returns regularly for such things as vehicle and equipment cleaning, discharging liquid or solid wastes, refilling water tanks and ice bins, and boarding food.

"Sewage" means liquid waste containing animal or vegetable matter in suspension or solution and may include liquids containing chemicals in solution. Sewage includes water-carried and non-water-carried human excrement or kitchen, laundry, shower, bath, or lavatory waste separately or together with such underground surface, storm, or other water and liquid industrial wastes as may be present from residences, buildings, vehicles, industrial establishments, or other places.

"Shellfish control authority" means a state, federal, foreign, tribal or other government entity legally responsible for administering a program that includes certification of molluscan shellfish harvesters and dealers for interstate commerce such as the Virginia Department of Health Division of Shellfish Sanitation.

"Shellstock" means live molluscan shellfish in the shell.

"Shiga toxin-producing Escherichia coli" or "STEC" means any E. coli capable of producing Shiga toxins (also called verocytotoxins). STEC infections can be asymptomatic or may result in a spectrum of illness ranging from mild nonbloody diarrhea to hemorrhagic colitis (i.e., bloody diarrhea) to hemolytic uremic syndrome (HUS), which is a type of kidney failure. Examples of serotypes of STEC include E. coli 0157:H7, E. coli 0157:NM, E. coli 026:H11; E. Coli 0145:NM, E. coli 0103:H2, and E. coli 0111:NM. STEC are sometimes referred to as VTEC (verocytotoxigenic E. coli) or as EHEC (Enterohemorrhagic E. coli). EHEC are a subset of STEC that can cause hemorrhagic colitis or HUS.

"Shucked shellfish" means molluscan shellfish that have both shells removed.

"Single-service articles" means tableware, carry-out utensils, and other items such as bags, containers, placemats, stirrers, straws, toothpicks, and wrappers that are designed and constructed for one time, one person use after which they are intended for discard.

"Single-use articles" means utensils and bulk food containers designed and constructed to be used once and discarded. Single-use articles includes items such as wax paper, butcher paper, plastic wrap, formed aluminum food containers, jars, plastic tubs or buckets, bread wrappers, pickle barrels, ketchup bottles, and number 10 cans that do not meet the materials, durability, strength, and cleanability specifications contained in 12VAC5-421-960, 12VAC5-421-1080, and 12VAC5-421-1100 for multiuse utensils.

"Slacking" means the process of moderating the temperature of a food such as allowing a food to gradually increase from a temperature of -10°F (-23°C) to 25°F (-4°C) in preparation for deep-fat frying or to facilitate even heat penetration during the cooking of previously block-frozen food such as shrimp.

"Smooth" means a food-contact surface having a surface free of pits and inclusions with a cleanability equal to or exceeding that of (100 grit) number three stainless steel; a non-food-contact surface of equipment having a surface equal to that of commercial grade hot-rolled steel free of visible scale; and a floor, wall, or ceiling having an even or level surface with no roughness or projections that render it difficult to clean.

"Substantial compliance" means equipment or structure design or construction; food preparation, handling, storage, transportation; or cleaning procedures that will not substantially affect health consideration or performance of the facility or the employees.

"Tableware" means eating, drinking, and serving utensils for table use such as flatware including forks, knives, and spoons; hollowware including bowls, cups, serving dishes, tumblers; and plates.

"Temperature measuring device" means a thermometer, thermocouple, thermistor, or other device that indicates the temperature of food, air, or water.

"Temporary food establishment" means a food establishment that operates for a period of no more than 14 consecutive days in conjunction with a single event or celebration.

"Time/temperature control for safety food" or "TCS food" means a food that requires time/temperature control for safety to limit pathogenic microorganism growth or toxin formation:

1. TCS food includes an animal food that is raw or heat treated; a plant food that is heat treated or consists of raw seed sprouts, cut melons, cut leafy greens, cut tomatoes, or mixtures of cut tomatoes that are not modified in a way so that they are unable to support pathogenic microorganism growth or toxin formation, or garlic-in-oil mixtures that are not modified in a way so that they are unable to support pathogenic microorganism growth or toxin formation; and except as specified in subdivision 2 d of this definition, a food that because of the interaction of its A_wand pH values is designated as product assessment required (PA) in Table A or B of this definition:

| Table A. Interaction of pH and A_w for control of spores in food heat treated to destroy vegetative cells and subsequently packaged. | | | | | --- | --- | --- | --- | | A_w values | pH values | | | | 4.6 or less | >4.6 - 5.6 | >5.6 | | | ≤0.92 | non-TCS food* | non-TCS food | non-TCS food | | >0.92 - 0.95 | non-TCS food | non-TCS food | PA** | | >0.95 | non-TCS food | PA | PA | | *TCS food means time/temperature control for safety food **PA means product assessment required | | | |

| Table B. Interaction of pH and A_w for control of vegetative cells and spores in food not heat treated or heat treated but not packaged. | | | | | | --- | --- | --- | --- | --- | | A_w values | pH values | | | | | < 4.2 | 4.2 - 4.6 | > 4.6 - 5.0 | > 5.0 | | | <0.88 | non-TCS food* | non-TCS food | non-TCS food | non-TCS food | | 0.88 - 0.90 | non-TCS food | non-TCS food | non-TCS food | PA** | | >0.90 - 0.92 | non-TCS food | non-TCS food | PA | PA | | >0.92 | non-TCS food | PA | PA | PA | | *TCS food means time/temperature control for safety food **PA means product assessment required | | | | |

2. TCS food does not include:

a. An air-cooled hard-boiled egg with shell intact, or an egg with shell intact that is not hard-boiled, but has been pasteurized to destroy all viable salmonellae;

b. A food in an unopened hermetically sealed container that is commercially processed to achieve and maintain commercial sterility under conditions of nonrefrigerated storage and distribution;

c. A food that because of its pH or A_w value, or interaction of A_w and pH values, is designated as a non-TCS food in Table A or B of this definition;

d. A food that is designated as PA in Table A or B of this definition and has undergone a product assessment showing that the growth or toxin formation of pathogenic microorganisms that are reasonably likely to occur in that food is precluded due to:

(1) Intrinsic factors including added or natural characteristics of the food such as preservatives, antimicrobials, humectants, acidulants, or nutrients;

(2) Extrinsic factors including environmental or operational factors that affect the food such as packaging, modified atmosphere such as reduced oxygen packaging, shelf-life and use, or temperature range of storage and use; or

(3) A combination of intrinsic and extrinsic factors; or

e. A food that does not support the growth or toxin formation of pathogenic microorganisms in accordance with one of the subdivisions 2 a through 2 d of this definition even though the food may contain a pathogenic microorganism or chemical or physical contaminant at a level sufficient to cause illness or injury.

"Tobacco product" has the meaning stated in the Federal Food, Drug and Cosmetic Act, § 201(rr) (21 USC § 321(rr)).

"USDA" means the U.S. Department of Agriculture.

"Utensil" means a food-contact implement or container used in the storage, preparation, transportation, dispensing, sale, or service of food, such as kitchenware or tableware that is multiuse, single service, or single use; gloves used in contact with food; temperature sensing probes of food temperature measuring devices and probe-type price or identification tags used in contact with food.

"Variance" means a written document issued by the department that authorizes a modification or waiver of one or more requirements of this chapter if, in the opinion of the department, a health hazard or nuisance will not result from the modification or waiver.

"Vending machine" means a self-service device that, upon insertion of a coin, paper currency, token, card, key, electronic transaction, or by optional manual operation, dispenses unit servings of food in bulk or in packages without the necessity of replenishing the device between each vending operation.

"Vending machine location" means the room, enclosure, space, or area where one or more vending machines are installed and operated and includes the storage areas and areas on the premises that are used to service and maintain the vending machines.

"Warewashing" means the cleaning and sanitizing of utensils and food-contact surfaces of equipment.

"Waterworks" means a system that serves piped water for human consumption to at least 15 service connections or 25 or more individuals for at least 60 days out of the year. "Waterworks" includes all structures, equipment and appurtenances used in the storage, collection, purification, treatment, and distribution of pure water except the piping and fixtures inside the building where such water is delivered (see Article 2 (§ 32.1-167 et seq.) of Chapter 6 of Title 32.1 of the Code of Virginia).

"Whole-muscle, intact beef" means whole muscle beef that is not injected, mechanically tenderized, reconstructed, or scored and marinated, from which beef steaks may be cut.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016; Volume 35, Issue 1, eff. October 3, 2018; Volume 37, Issue 18, eff. June 10, 2021; Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-20 [Reserved]. (Reserved)

12VAC5-421-30 Purpose

This chapter has been promulgated by the board to specify the following requirements to protect public health:

1. A procedure for obtaining a license (permit);

2. Criteria for assuring the safe preparation, handling, protection and/or temperature control for food;

3. Criteria for the safe and sanitary maintenance, storage, operation and use of equipment;

4. Requirements that food establishments utilize an approved water supply and sewage disposal system;

5. Requirements for toilet and cleansing facilities for employees ;

6. Criteria for vector and pest control;

7. Requirements for the sanitary maintenance and use of food establishment's physical plant;

8. Requirements for appropriate lighting and ventilation not otherwise provided for in the Uniform Statewide Building Code; and

9. A classification system for food establishments.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-40 Administration of regulation

This chapter is administered by the following:

1. The board has responsibility to promulgate, amend and repeal regulations necessary to protect the public health.

2. The commissioner is the chief executive officer of the department. The commissioner has the authority to act within the scope of regulations promulgated by the board and for the board when it is not in session.

3. The director is responsible for the permitting and inspection of food establishments located within the director's district and for assuring compliance with this chapter.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

Article 1 Supervision

12VAC5-421-50 Assignment of responsibility

A. Except as specified in subsections B and C of this section, the permit holder shall be the person in charge or shall designate a person in charge and shall ensure that a person in charge is present at the food establishment during all hours of operation.^Pf

B. In a food establishment with two or more separately permitted departments that are the legal responsibility of the same permit holder and that are located on the same premises, the permit holder may, during specific time periods when food is not being prepared, packaged, or served, designate a single person in charge who is present on the premises during all hours of operation, and who is responsible for each separately permitted food establishment on the premises.^Pf

C. This section shall not apply to certain types of food establishments deemed by the department to pose minimal risk of causing or contributing to foodborne illness based on the nature of the operation and extent of the food preparation.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 26, Issue 7, eff. January 1, 2010; Errata, 26:9 VA.R. 1316 January 4, 2009; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016; Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-55 Certified food protection manager

A. At least one employee with supervisory and management responsibility and the authority to direct and control food preparation and service shall be a certified food protection manager, demonstrating proficiency of required knowledge and information through passing a test that is part of an accredited program.

B. This section does not apply to food establishments that serve only non-time/temperature control for safety food and food establishments that store and prepare food only to the extent that they reheat or cold hold commercially processed, fully cooked time/temperature control for safety foods. Food establishments exempt from the certified food protection manager requirement may not cool time/temperature control for safety foods.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 22, eff. July 12, 2016; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021; Errata 37:23 VA.R. 3482 July 5, 2021; amended, Virginia Register Volume 39, Issue 5, eff. November 23, 2022.

12VAC5-421-60 Demonstration of knowledge

Based on the risks of foodborne illness inherent to the food operation, during inspections and upon request the person in charge shall demonstrate to the department knowledge of foodborne disease prevention, and the requirements of this chapter. The person in charge shall demonstrate this knowledge by:

1. Complying with this chapter by having no violations of priority items during the current inspection;^Pf

2. Being a certified food protection manager who has shown proficiency of required information through passing a test that is part of an accredited program;^Pfor

3. Responding correctly to the environmental health specialist's questions as they relate to the specific food operation. The areas of operation may include:

a. Describing the relationship between the prevention of foodborne disease and the personal hygiene of a food employee;^Pf

b. Explaining the responsibility of the person in charge for preventing the transmission of foodborne disease by a food employee who has a disease or medical condition that may cause foodborne disease;^Pf

c. Describing the symptoms associated with the diseases that are transmissible through food;^Pf

d. Explaining the significance of the relationship between maintaining the time and temperature of time/temperature control for safety food and the prevention of foodborne illness;^Pf

e. Explaining the hazards involved in the consumption of raw or undercooked meat, poultry, eggs, and fish;^Pf

f. Stating the required food temperatures and times for safe cooking of time/temperature control for safety food including meat, poultry, eggs, and fish;^Pf

g. Stating the required temperatures and times for the safe refrigerated storage, hot holding, cooling, and reheating of time/temperature control for safety food;^Pf

h. Describing the relationship between the prevention of foodborne illness and the management and control of the following:

(1) Cross contamination;^Pf

(2) Hand contact with ready-to-eat foods;^Pf

(3) Handwashing;^Pf and

(4) Maintaining the food establishment in a clean condition and in good repair;^Pf

i. Describing the foods identified as major food allergens and the symptoms that a major food allergen could cause in a sensitive individual who has an allergic reaction;^Pf

j. Explaining the relationship between food safety and providing equipment that is:

(1) Sufficient in number and capacity;^Pfand

(2) Properly designed, constructed, located, installed, operated, maintained, and cleaned;^Pf

k. Explaining correct procedures for cleaning and sanitizing utensils and food-contact surfaces of equipment;^Pf

l. Identifying the source of water used and measures taken to ensure that the water supply remains protected from contamination such as providing protection from backflow and precluding the creation of cross connections;^Pf

m. Identifying poisonous or toxic materials in the food establishment and the procedures necessary to ensure that they are safely stored, dispensed, used, and disposed of according to law;^Pf

n. Identifying critical control points in the operation from purchasing through sale or service that when not controlled may contribute to the transmission of foodborne illness and explaining steps taken to ensure that the points are controlled in accordance with the requirements of this chapter;^Pf

o. Explaining the details of how the person in charge and food employees comply with a HACCP plan if such a plan is required by law, this chapter, or a an agreement between the department and the food establishment;^Pf

p. Explaining the responsibilities, rights, and authorities assigned by this chapter to the:

(1) Food employee;^Pf

(2) Conditional employee;^Pf

(3) Person in charge;^Pfand

(4) Department;^Pfand

q. Explaining how the person in charge, food employees, and conditional employees comply with reporting responsibilities and the exclusion or restriction of food employees.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-65 Food protection manager certification

A. A person in charge who demonstrates knowledge by being a food protection manager who is certified by a food protection manager certification program that is evaluated and listed by a Conference for Food Protection-recognized accrediting agency as conforming to the Conference for Food Protection Standards for Accreditation of Food Protection Manager Certification Programs, April 2012, (Conference for Food Protection) is deemed to comply with subdivision 2 of 12VAC5-421-60.

B. A food establishment that has an employee who is certified by a food protection certification program that is evaluated and listed by a Conference for Food Protection-recognized accrediting agency as conforming to the Conference for Food Protection Standards for Accreditation of Food Protection Manager Certification Programs, April 2012, (Conference for Food Protection) is deemed to comply with 12VAC5-421-55.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 22, eff. July 12, 2016; amended, Virginia Register Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-70 Duties of person in charge

The person in charge shall ensure that:

1. Food establishment operations are not conducted in a private home or in a room used as living or sleeping quarters as specified under 12VAC5-421-2990;^Pf

2. Persons unnecessary to the food establishment operation are not allowed in the food preparation, food storage, or warewashing areas, except that brief visits and tours may be authorized by the person in charge if steps are taken to ensure that exposed food; clean equipment, utensils, and linens; and unwrapped single-service and single-use articles are protected from contamination;^Pf

3. Employees and other persons such as delivery and maintenance persons and pesticide applicators entering the food preparation, food storage, and warewashing areas comply with this chapter;^Pf

4. Employees are effectively cleaning their hands, by routinely monitoring the employees' handwashing;^Pf

5. Employees are visibly observing foods as they are received to determine that they are from approved sources, delivered at the required temperatures, protected from contamination, unadulterated, and accurately presented, by routinely monitoring the employees' observations and periodically evaluating foods upon their receipt;^Pf

6. Employees are verifying that foods delivered to the food establishment during non-operating hours are from approved sources and are placed into appropriate storage locations such that they are maintained at the required temperatures, protected from contamination, unadulterated, and accurately presented;^Pf

7. Employees are properly cooking time/temperature control for safety food, being particularly careful in cooking those foods known to cause severe foodborne illness and death, such as eggs and comminuted meats, through daily oversight of the employees' routine monitoring of the cooking temperatures using appropriate temperature measuring devices properly scaled and calibrated as specified under 12VAC5-421-1180 and 12VAC5-421-1730 B;^Pf

8. Employees are using proper methods to rapidly cool time/temperature control for safety food that is not held hot or is not for consumption within four hours, through daily oversight of the employees' routine monitoring of food temperatures during cooling;^Pf

9. Employees are properly maintaining the temperatures of time/temperature control for safety food during hot and cold holding through daily oversight of the employees routine monitoring of food temperatures;^Pf

10. Food employees are properly maintaining the temperature of time/temperature control for safety foods during thawing through daily oversight of the food employees' routine monitoring of food temperatures;^Pf

11. Consumers who order raw or partially cooked ready-to-eat foods of animal origin are informed as specified under 12VAC5-421-930 that the food is not cooked sufficiently to ensure its safety;^Pf

12. Employees are properly sanitizing cleaned multiuse equipment and utensils before they are reused, through routine monitoring of solution temperature and exposure time for hot water sanitizing, and chemical concentration, pH, temperature, and exposure time for chemical sanitizing;^Pf

13. Consumers are notified that clean tableware is to be used when they return to self-service areas such as salad bars and buffets as specified in 12VAC5-421-590;^Pf

14. Except when approval is obtained from the department as specified in 12VAC5-421-450 E, employees are preventing cross-contamination of ready-to-eat food with bare hands by properly using suitable utensils such as deli tissue, spatulas, tongs, single-use gloves, or dispensing equipment; ^Pf

15. Employees are properly trained in food safety, including food allergy awareness, as it relates to their assigned duties. Food allergy awareness includes describing foods identified as major food allergens and the symptoms that a major food allergen could cause in a sensitive individual who has an allergic reaction;^Pf

16. Food employees and conditional employees are informed in a verifiable manner of their responsibility to report in accordance with law, to the person in charge, information about their health and activities as they relate to diseases that are transmissible through food, as specified under 12VAC5-421-80;^Pf and

17. Written procedures and plans, where specified by this chapter and as developed by the food establishment, are maintained and implemented as required.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021; Volume 42, Issue 25, eff. September 10, 2026.

Article 2 Employee Health

12VAC5-421-80 Responsibility of permit holder, person in charge, and conditional employees

A. The permit holder shall require food employees and conditional employees to report to the person in charge information about their health and activities as they relate to diseases that are transmissible through food. A food employee or conditional employee shall report the information in a manner that allows the person in charge to reduce the risk of foodborne disease transmission, including providing necessary additional information, such as the date of onset of symptoms and an illness, or of a diagnosis without symptoms, if the food employee or conditional employee:

1. Has any of the following symptoms:

a. Vomiting;^P

b. Diarrhea;^P

c. Jaundice;^P

d. Sore throat with fever;^P or

e. A lesion containing pus such as a boil or infected wound that is open or draining and is:

(1) On the hands or wrists, unless an impermeable cover such as a finger cot or stall protects the lesion and a single-use glove is worn over the impermeable cover;^P

(2) On exposed portions of the arms, unless the lesion is protected by an impermeable cover;^P or

(3) On other parts of the body, unless the lesion is covered by a dry, durable, tight-fitting bandage;^P

2. Has an illness diagnosed by a health practitioner due to:

a. Norovirus;^P

b. Hepatitis A virus;^P

c. Shigella spp.;^P

d. Shiga toxin-producing Escherichia coli; ^P

e. Typhoid fever (caused by Salmonella typhi);^P or

f. Salmonella (nontyphoidal);^P

3. Had Typhoid fever, diagnosed by a health practitioner, within the past three months, without having received antibiotic therapy, as determined by a health practitioner;^P

4. Has been exposed to, or is the suspected source of, a confirmed disease outbreak, because the food employee or conditional employee consumed or prepared food implicated in the outbreak, or consumed food at an event prepared by a person who is infected or ill with:

a. Norovirus within the past 48 hours of the last exposure;^P

b. Shiga toxin-producing Escherichia coli, or Shigella spp. within the past three days of the last exposure;^P

c. Typhoid fever (caused by Salmonella typhi) within the past 14 days of the last exposure;^P or

d. Hepatitis A virus within the past 30 days of the last exposure;^P or

5. Has been exposed by attending or working in a setting where there is a confirmed disease outbreak, or living in the same household as, and has knowledge about an individual who works or attends a setting where there is a confirmed disease outbreak, or living in the same household as and has knowledge about, an individual diagnosed with an illness caused by:

a. Norovirus within the past 48 hours of the last exposure;^P

b. Shiga toxin-producing Escherichia coli or Shigella spp. within the past three days of the last exposure;^P

c. Typhoid fever (caused by Salmonella typhi) within the past 14 days of the last exposure;^P or

d. Hepatitis A virus within the past 30 days of the last exposure.^P

B. The person in charge shall notify the department when a food employee is:

1. Jaundiced;^Pf or

2. Diagnosed with an illness due to a pathogen as specified under subdivisions A 2 a through A 2 f of this section.^Pf

C. The person in charge shall ensure that a conditional employee:

1. Who exhibits or reports a symptom, or who reports a diagnosed illness as specified under subdivisions A 1, A 2, and A 3 of this section, is prohibited from becoming a food employee until the conditional employee meets the criteria for the specific symptoms or diagnosed illness as specified under 12VAC5-421-100;^P and

2. Who will work as a food employee in a food establishment that serves a highly susceptible population and reports a history of exposure as specified under subdivisions A 4 and A 5 of this section, is prohibited from becoming a food employee until the conditional employee meets the criteria specified under subdivision 10 of 12VAC5-421-100.^P

D. The person in charge shall ensure that a food employee who exhibits or reports a symptom, or who reports a diagnosed illness or history of exposure as specified under subdivisions A 1 through A 5 of this section is:

1. Excluded as specified under subdivisions 1, 2, and 3 of 12VAC5-421-90, and subdivision 4 a, 5 a, 6 a, or 8 a of 12VAC5-421-90 and in compliance with the provisions specified under subdivisions 1 through 8 of 12VAC5-421-100;^P or

2. Restricted as specified under subdivision 4 b, 5 b, 6 b, 7, or 8 b of 12VAC5-421-90, or subdivision 9 or 10 of 12VAC5-421-90 and in compliance with the provisions specified under subdivisions 4 through 10 of 12VAC5-421-100.^P

E. A food employee or conditional employee shall report to the person in charge the information as specified under subsection A of this section.^Pf

F. A food employee shall:

1. Comply with an exclusion as specified under subdivisions 1, 2, and 3 of 12VAC5-421-90 and subdivision 4 a, 5 a, 6 a, 7, or 8 a of 12VAC5-421-90 and with the provisions specified under subdivisions 1 through 8 of 12VAC5-421-100;^P or

2. Comply with a restriction as specified under subdivision 4 b, 5 b, 6 b, 7, or 8 b of 12VAC5-421-90, or subdivision 8, 9, or 10 of 12VAC5-421-90 and comply with the provisions specified under subdivisions 4 through 10 of 12VAC5-421-100.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021; Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-90 Exclusions and restrictions

The person in charge shall exclude or restrict a food employee from a food establishment in accordance with the following:

1. Except when the symptom is from a noninfectious condition, exclude a food employee if the food employee is:

a. Symptomatic with vomiting or diarrhea;^P or

b. Symptomatic with vomiting or diarrhea and diagnosed with an infection from Norovirus, Shigella spp., Salmonella (nontyphoidal), or Shiga toxin-producing Escherichia coli.^P

2. Exclude a food employee who is:

a. Jaundiced and the onset of jaundice occurred within the last seven calendar days, unless the food employee provides to the person in charge written medical documentation from a health practitioner specifying that the jaundice is not caused by Hepatitis A virus or other fecal-orally transmitted infection;^P

b. Diagnosed with an infection from Hepatitis A virus within 14 calendar days from the onset of any illness symptoms, or within seven calendar days of the onset of jaundice;^P or

c. Diagnosed with an infection from Hepatitis A virus without developing symptoms.^P

3. Exclude a food employee who is diagnosed with Typhoid fever, or reports having had Typhoid fever within the past three months as specified in 12VAC5-421-80 A 3.^P

4. If a food employee is diagnosed with an infection from Norovirus and is asymptomatic:

a. Exclude the food employee who works in a food establishment serving a highly susceptible population;^P or

b. Restrict the food employee who works in a food establishment not serving a highly susceptible population.^P

5. If a food employee is diagnosed with an infection from Shigella spp. and is asymptomatic:

a. Exclude the food employee who works in a food establishment serving a highly susceptible population;^P or

b. Restrict the food employee who works in a food establishment not serving a highly susceptible population.^P

6. If a food employee is diagnosed with an infection from Shiga toxin-producing Escherichia coli, and is asymptomatic:

a. Exclude the food employee who works in a food establishment serving a highly susceptible population;^Por

b. Restrict the food employee who works in a food establishment not serving a highly susceptible population.^P

7. If a food employee is diagnosed with an infection from Salmonella(nontyphoidal) and is asymptomatic, restrict the food employee who works in a food establishment:

a. Serving a highly susceptible population,^P or

b. Not serving a highly susceptible population.^P

8. If a food employee is ill with symptoms of acute onset of sore throat with fever:

a. Exclude the food employee who works in a food establishment serving a highly susceptible population;^P or

b. Restrict the food employee who works in a food establishment not serving a highly susceptible population.^P

9. If a food employee is infected with a skin lesion containing pus such as a boil or infected wound that is open or draining and not properly covered as specified under 12VAC5-421-80 A 1 e, restrict the food employee.^P

10. If a food employee is exposed to a foodborne pathogen as specified under 12VAC5-421-80 A 4 or 5, restrict the food employee who works in a food establishment serving a highly susceptible population.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-100 Removal, adjustment, or retention of exclusions and restrictions

The person in charge shall adhere to the following conditions when removing, adjusting, or retaining the exclusion or restriction of a food employee:

1. Except when a food employee is diagnosed with Typhoid fever or an infection from Hepatitis A virus:

a. Reinstate a food employee who was excluded as specified under subdivision 1 a of 12VAC5-421-90 if the food employee:

(1) Is asymptomatic for at least 24 hours;^P or

(2) Provides to the person in charge written medical documentation from a health practitioner that states the symptom is from a noninfectious condition.^P

b. If a food employee was diagnosed with an infection from Norovirus and excluded as specified under subdivision 1 b of 12VAC5-421-90:

(1) Restrict the food employee, who is asymptomatic for at least 24 hours and works in a food establishment not serving a highly susceptible population until the conditions for reinstatement as specified in subdivision 4 a or b of this section are met;^P or

(2) Retain the exclusion for the food employee, who is asymptomatic for at least 24 hours and works in a food establishment that serves a highly susceptible population, until the conditions for reinstatement as specified in subdivision 4 a or b of this section are met.^P

c. If a food employee was diagnosed with an infection from Shigella spp. and excluded as specified under subdivision 1 b of 12VAC5-421-90:

(1) Restrict the food employee, who is asymptomatic, for at least 24 hours and works in a food establishment not serving a highly susceptible population, until the conditions for reinstatement as specified in subdivision 5 a or b of this section are met;^P or

(2) Retain the exclusion for the food employee, who is asymptomatic for at least 24 hours and works in a food establishment that serves a highly susceptible population, until the conditions for reinstatement as specified in subdivision 5 a or b, or 5 a and 1 c (1) of this section are met.^P

d. If a food employee was diagnosed with an infection from Shiga toxin-producing Escherichia coli and excluded as specified under subdivision 1 b of 12VAC5-421-90:

(1) Restrict the food employee, who is asymptomatic for at least 24 hours and works in a food establishment not serving a highly susceptible population, until the conditions for reinstatement as specified in subdivision 6 a or b of this section are met;^P or

(2) Retain the exclusion for the food employee, who is asymptomatic for at least 24 hours and works in a food establishment that serves a highly susceptible population, until the conditions for reinstatement as specified in subdivision 6 a or b are met.^P

e. If a food employee was diagnosed with an infection from Salmonella(nontyphoidal) and excluded as specified under subdivision 1 b of 12VAC5-421-90:

(1) Restrict the food employee who is asymptomatic for at least 30 days until conditions for reinstatement as specified under subdivision 7 a or 7 b of this section are met;^Por

(2) Retain the exclusion for the food employee who is symptomatic, until conditions for reinstatement as specified under subdivision 7 a or 7 b of this section are met.^P

2. Reinstate a food employee who was excluded as specified under subdivision 2 of 12VAC5-421-90 if the person in charge obtains approval from the department and one of the following conditions is met:

a. The food employee has been jaundiced for more than seven calendar days;^P

b. The anicteric food employee has been symptomatic with symptoms other than jaundice for more than 14 calendar days;^P or

c. The food employee provides to the person in charge written medical documentation from a health practitioner stating that the food employee is free of a Hepatitis A virus infection.^P

3. Reinstate a food employee who was excluded as specified under subdivision 3 of 12VAC5-421-90 if:

a. The person in charge obtains approval from the department;^P and

b. The food employee provides to the person in charge written medical documentation from a health practitioner that states the employee is free from Typhoid fever.^P

4. Reinstate a food employee who was excluded as specified under subdivision 1 b or 4 a of 12VAC5-421-90, who was restricted under subdivision 4 b of 12VAC5-421-90 if the person in charge obtains approval from the department and one of the following conditions is met:

a. The excluded or restricted food employee provides to the person in charge written medical documentation from a health practitioner stating that the food employee is free of a Norovirus infection;^P

b. The food employee was excluded or restricted after symptoms of vomiting or diarrhea resolved, and more than 48 hours have passed since the food employee became asymptomatic;^Por

c. The food employee was excluded or restricted and did not develop symptoms and more than 48 hours have passed since the food employee was diagnosed.^P

5. Reinstate a food employee who was excluded as specified under subdivision 1 b or 5 a of 12VAC5-421-90 or who was restricted under subdivision 5 b of 12VAC5-421-90 if the person in charge obtains approval from the department and one of the following conditions is met:

a. The excluded or restricted food employee provides to the person in charge written medical documentation from a health practitioner stating that the food employee is free of a Shigella spp. infection based on test results showing two consecutive negative stool specimen cultures that are taken:

(1) Not earlier than 48 hours after discontinuance of antibiotics,^P and

(2) At least 24 hours apart;^P

b. The food employee was excluded or restricted after symptoms of vomiting or diarrhea resolved, and more than seven calendar days have passed since the food employee became asymptomatic;^Por

c. The food employee was excluded or restricted and did not develop symptoms and more than seven calendar days have passed since the food employee was diagnosed.^P

6. Reinstate a food employee who was excluded or restricted as specified under subdivision 1 b or 6 a of 12VAC5-421-90 or who was restricted under subdivision 6 b of 12VAC5-421-90 if the person in charge obtains approval from the department and one of the following conditions is met:

a. The excluded or restricted food employee provides to the person in charge written medical documentation from a health practitioner stating that the food employee is free of an infection from Shiga toxin-producing Escherichia coli based on test results that show two consecutive negative stool specimen cultures that are taken:

(1) Not earlier than 48 hours after the discontinuance of antibiotics;^Pand

(2) At least 24 hours apart;^P

b. The food employee was excluded or restricted after symptoms of vomiting or diarrhea resolved and more than seven calendar days have passed since the employee became asymptomatic;^P or

c. The food employee was excluded or restricted and did not develop symptoms and more than seven days have passed since the employee was diagnosed.^P

7. Reinstate a food employee who was excluded as specified under subsection 1 b of 12VAC5-421-90 or who was restricted as specified under subsection 7 of 12VAC5-421-90 if the person in charge obtains approval from the department^Pand one of the following conditions is met:

a. The excluded or restricted food employee provides to the person in charge written medical documentation from a health practitioner stating that the food employee is free of a Salmonella (nontyphoidal) infection based on test results showing two consecutive negative stool specimen cultures that are taken:

(1) Not earlier than 48 hours after discontinuance of antibiotics;^Pand

(2) At least 24 hours apart;^P

b. The food employee was restricted after symptoms of vomiting or diarrhea resolved, and more than 30 days have passed since the food employee became asymptomatic;^Por

c. The food employee was excluded or restricted and did not develop symptoms and more than 30 days have passed since the food employee was diagnosed.^P

8. Reinstate a food employee who was excluded or restricted as specified under subdivision 8 a or b of 12VAC5-421-90 if the food employee provides to the person in charge written medical documentation from a health practitioner stating that the food employee meets one of the following conditions:

a. Has received antibiotic therapy for Streptococcus pyogenes infection for more than 24 hours;^P

b. Has at least one negative throat specimen culture for Streptococcus pyogenes infection;^Por

c. Is otherwise determined by a health practitioner to be free of Streptococcus pyogenes infection.^P

9. Reinstate a food employee who was restricted as specified under subdivision 9 of 12VAC5-421-90 if the skin, infected wound, cut, or pustular boil is properly covered with one of the following:

a. An impermeable cover such as a finger cot or stall and a single-use glove over the impermeable cover if the infected wound or pustular boil is on the hand, finger, or wrist;^P

b. An impermeable cover on the arm if the infected wound or pustular boil is on the arm;^P or

c. A dry, durable, tight-fitting bandage if the infected wound or pustular boil is on another part of the body.^P

10. Reinstate a food employee who was restricted as specified under subdivision 10 of 12VAC5-421-90 and was exposed to one of the following pathogens as specified under 12VAC5-421-80 A 4 or 5:

a. Norovirus and one of the following conditions is met:

(1) More than 48 hours have passed since the last day the food employee was potentially exposed;^P or

(2) More than 48 hours have passed since the food employee's household contact became asymptomatic.^P

b. Shigella spp. or Shiga toxin-producing Escherichia coli and one of the following conditions is met:

(1) More than three calendar days have passed since the last day the food employee was potentially exposed;^P or

(2) More than three calendar days have passed since the food employee's household contact became asymptomatic.^P

c. Typhoid fever (caused by Salmonella typhi) and one of the following conditions is met:

(1) More than 14 calendar days have passed since the last day the food employee was potentially exposed;^Por

(2) More than 14 calendar days have passed since the food employee's household contact became asymptomatic.^P

d. Hepatitis A virus and one of the following conditions is met:

(1) The food employee is immune to Hepatitis A virus infection because of prior illness from Hepatitis A;^P

(2) The food employee is immune to Hepatitis A virus infection because of vaccination against Hepatitis A;^P

(3) The food employee is immune to Hepatitis A virus infection because of IgG administration;^P

(4) More than 30 calendar days have passed since the last time the food employee was potentially exposed;^P

(5) More than 30 calendar days have passed since the food employee's household contact became jaundiced;^P or

(6) The food employee does not use an alternative procedure that allows bare hand contact with ready-to-eat food until at least 30 days after the potential exposure, as specified in subdivisions 10 d (4) and (5) of this section, and the food employee receives additional training about:

(a) Hepatitis A symptoms and preventing the transmission of infection;^P

(b) Proper handwashing procedures;^P and

(c) Protecting ready-to-eat food from contamination introduced by bare hand contact.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-110 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; repealed, Virginia Register Volume 26, Issue 7, eff. January 1, 2010.

12VAC5-421-120 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; repealed, Virginia Register Volume 26, Issue 7, eff. January 1, 2010.

Article 3 Personal Cleanliness

12VAC5-421-130 Clean condition of hands and arms

Food employees shall keep their hands and exposed portions of their arms clean.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-140 Cleaning procedure of hands and arms

A. Except as specified in subsection D of this section, food employees shall clean their hands and exposed portions of their arms or surrogate prosthetic devices for hands or arms for at least 20 seconds, using a cleaning compound in a lavatory that is equipped as specified under 12VAC5-421-2190.^P

B. Food employees shall use the following cleaning procedure in the order stated to clean their hands and exposed portions of their arms, including surrogate prosthetic devices for hands and arms:

1. Rinse under clean, running warm water;^P

2. Apply an amount of cleaning compound recommended by the cleaning compound manufacturer;^P

3. Rub together vigorously for at least 10 to 15 seconds while:

a. Paying particular attention to removing soil from underneath the fingernails during the cleaning procedure;^P and

b. Creating friction on the surfaces of the hands and arms or surrogate prosthetic devices for hands and arms, finger tips, and areas between the fingers;^P

4. Thoroughly rinsing under clean, running warm water;^Pand

5. Immediately follow the cleaning procedure with thorough drying using a method as specified under 12VAC5-421-3030.^P

C. To avoid recontaminating their hands or surrogate prosthetic devices, food employees may use disposable paper towels or similar clean barriers when touching surfaces such as manually operated faucet handles on a handwashing sink or the handle of a restroom door.

D. If approved and capable of removing the types of soils encountered in the food operations involved, an automatic handwashing facility may be used by food employees to clean their hands or surrogate prosthetic devices.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-150 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; repealed, Virginia Register Volume 26, Issue 7, eff. January 1, 2010.

12VAC5-421-160 When to wash

Food employees shall clean their hands and exposed portions of their arms as specified under 12VAC5-421-140 immediately before engaging in food preparation including working with exposed food, clean equipment and utensils, and unwrapped single-service and single-use articles^P and:

1. After touching bare human body parts or hair other than clean hands and clean, exposed portions of arms;^P

2. After using the toilet room;^P

3. After caring for or handling service animals or aquatic animals as allowed under 12VAC5-421-250 B;^P

4. Except as specified in 12VAC5-421-220 B, after coughing, sneezing, using a handkerchief or disposable tissue, using tobacco products, eating, or drinking;^P

5. After handling soiled equipment or utensils;^P

6. During food preparation, as often as necessary to remove soil and contamination and to prevent cross contamination when changing tasks;^P

7. When switching between working with raw foods and working with ready-to-eat foods;^P

8. Before donning gloves to initiate a task that involves working with foods;^P and

9. After engaging in other activities that contaminate the hands.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016; Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-170 Where to wash

Food employees shall clean their hands in a handwashing sink or approved automatic handwashing facility and shall not clean their hands (i) in a sink used for food preparation or utensil washing or (ii) in a service sink or a curbed cleaning facility used for the disposal of mop water and similar liquid waste.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-180 Hand antiseptics

A. A hand antiseptic used as a topical application, a hand antiseptic solution used as a hand dip, or a hand antiseptic soap shall:

1. Comply with one of the following:

a. Be an approved drug that is listed in the FDA publication "Approved Drug Products with Therapeutic Equivalence Evaluations," 39th Edition, 2019 (U.S. Food and Drug Administration) as an approved drug based on safety and effectiveness;^Pf or

b. Have active antimicrobial ingredients that are listed in the FDA monograph for OTC (over the counter) Health-Care Antiseptic Drug Products as an antiseptic handwash;^Pf

2. Consist only of components which the intended use of each complies with one of the following:

a. A threshold of regulation exemption under 21 CFR 170.39;^Pf

b. 21 CFR Part 178, as regulated for use as a food additive with conditions of safe use;^Pf

c. A determination of generally recognized as safe (GRAS). Partial listings of substances with food uses that are GRAS may be found in 21 CFR Part 182, 21 CFR 184, or 21 CFR Part 186 for use in contact with food and in FDA's Inventory of GRAS Notices;^Pf

d. A prior sanction listed under 21 CFR 181;^Pfor

e. A food contact notification that is effective;^Pfand

3. Be applied only to hands that are cleaned as specified under 12VAC5-421-140.^Pf

B. If a hand antiseptic or a hand antiseptic solution used as a hand dip does not meet the criteria specified in subdivision A 2 of this section, use shall be:

1. Followed by thorough hand rinsing in clean water before hand contact with food or by the use of gloves;^Pf or

2. Limited to situations that involve no direct contact with food by the bare hands.^Pf

C. A hand antiseptic solution used as a hand dip shall be maintained clean and at a strength equivalent to at least 100 ppm (mg/l) chlorine .^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-190 Maintenance of fingernails

A. Food employees shall keep their fingernails trimmed, filed, and maintained so the edges and surfaces are cleanable and not rough.^Pf

B. Unless wearing intact gloves in good repair, a food employee shall not wear fingernail polish or artificial nails when working with exposed food.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-200 Prohibition of jewelry

Except for a plain ring such as a wedding band, while preparing food, food employees shall not wear jewelry, including medical information jewelry on their arms and hands.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-210 Clean condition of outer clothing

Food employees shall wear clean outer clothing to prevent contamination of food, equipment, utensils, linens, and single-service and single-use articles.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

Article 4 Hygienic Practices

12VAC5-421-220 Eating, drinking, or using tobacco products

A. Except as specified in subsection B of this section, an employee shall eat, drink, or use any form of tobacco products only in designated areas where the contamination of exposed food; clean equipment, utensils, and linens; unwrapped single-service and single-use articles; or other items needing protection cannot result.

B. A food employee may drink from a closed beverage container if the container is handled to prevent contamination of:

1. The employee's hands;

2. The container; and

3. Exposed food; clean equipment, utensils, and linens; and unwrapped single-service and single-use articles.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016; Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-230 Discharges from the eyes, nose, and mouth

Food employees experiencing persistent sneezing, coughing, or a runny nose that causes discharges from the eyes, nose, or mouth shall not work with exposed food; clean equipment, utensils, and linens; or unwrapped single-service or single-use articles.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007.

12VAC5-421-235 Use of bandages, finger cots, or finger stalls

If used, an impermeable cover such as a bandage, finger cot, or finger stall located on the wrist, hand, or finger of the food employee working with exposed food shall be covered with a single-use glove.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-240 Effectiveness of hair restraints

A. Except as provided under subsection B of this section, food employees shall wear hair restraints, such as hats, hair coverings or nets, beard restraints, and clothing that covers body hair, that are designed and worn to effectively keep their hair from contacting exposed food; clean equipment, utensils, and linens; and unwrapped single-service and single-use articles.

B. This section does not apply to food employees such as counter staff who only serve beverages and wrapped or packaged foods, hostesses, and wait staff if they present a minimal risk of contaminating exposed food; clean equipment, utensils, and linens; and unwrapped single-service and single-use articles.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-250 Handling of animals prohibited

A. Except as specified in subsection B of this section, a food employee may not care for or handle animals that may be present such as patrol dogs, service animals, or pets that are allowed under 12VAC5-421-3310 B 2, B 3, B 4, and B 6.^Pf

B. A food employee with a service animal may handle or care for the service animal, and a food employee may handle or care for fish in aquariums or molluscan shellfish or crustacea in display tanks if the food employee washes his hands as specified under 12VAC5-421-140 and subdivision 3 of 12VAC5-421-160.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016; Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-255 Clean-up of vomiting and diarrheal events

A food establishment shall have written procedures for employees to follow when responding to vomiting or diarrheal events that involve the discharge of vomitus or fecal matter onto surfaces in the food establishment. The procedures shall address the specific actions employees must take to minimize the spread of contamination and the exposure of employees, consumers, food, and surfaces to vomitus or fecal matter.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 22, eff. July 12, 2016; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

Article 1 Characteristics

12VAC5-421-260 Safe , unadulterated, and honestly presented

Food shall be safe, unadulterated, and, as specified in 12VAC5-421-890, honestly presented.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

Article 2 Sources, Specifications, and Original Containers and Records

12VAC5-421-270 Compliance with food law

A. Food shall be obtained from sources that comply with law.^P

B. Food prepared in a private home shall not be used or offered for human consumption in a food establishment unless the home kitchen is inspected and regulated by the Virginia Department of Agriculture and Consumer Services.^Pf

C. Packaged food shall be labeled as specified in law, including 21 CFR Part 101, 9 CFR Part 317, and Subpart N of 9 CFR Part 381, and as specified under 12VAC5-421-410.^Pf

D. Fish, other than those specified in 12VAC5-421-730 B, that are intended for consumption in raw or undercooked form and allowed as specified in 12VAC5-421-700 D, may be offered for sale or service if they are obtained from a supplier that freezes fish as specified under 12VAC5-421-730 A; or if the fish are frozen on premises as specified under 12VAC5-421-730 A and records are retained as specified under 12VAC5-421-740.

E. Whole-muscle, intact beef steaks that are intended for consumption in an undercooked form without a consumer advisory as specified in 12VAC5-421-700 C shall be:

1. Obtained from a food processing plant that does not mechanically tenderize, vacuum tumble with solutions, reconstruct, cube, or pound the whole-muscle, intact beef steaks;^Pf or

2. Deemed acceptable by the department based on other evidence, such as written buyer specifications or invoices, that indicates that the steaks meet the definition of whole-muscle, intact beef;^Pf and

3. If individually cut in a food establishment:

a. Cut from whole-muscle intact beef that is received from a food processing plant as specified in subdivision 1 of this subsection or identified as specified in subdivision 2 of this subsection;^P and

b. Prepared so they remain intact.^Pf

F. Meat and poultry that is not a ready-to-eat food and is in a packaged form when offered for sale or otherwise offered for consumption shall be labeled to include safe handling instructions as specified in law, including 9 CFR 317.2(l) and 9 CFR 381.125(b).

G. Eggs that have not been specifically treated to destroy all viable Salmonellae shall be labeled to include safe handling instructions as specified in law, including 21 CFR 101.17(h).

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016V; Volume 37, Issue 18, eff. June 10, 2021; Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-280 Food in a hermetically sealed container

Food in a hermetically sealed container shall be obtained from a food processing plant that is regulated by the food regulatory agency that has jurisdiction over the plant.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-290 Fluid milk and milk products

Fluid milk and milk products shall be obtained from sources that comply with Grade A standards as specified in law.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-295 Juice treated

Prepackaged juice shall:

1. Be obtained from a processor with a HACCP system as specified in 21 CFR Part 120;^Pfand

2. Be obtained pasteurized or otherwise treated to attain a five-log reduction of the most resistant microorganism of public health significance as specified in 21 CFR 120.24.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 2, eff. October 16, 2007; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-300 Fish

A. Fish that are received for sale or service shall be:

1. Commercially and legally caught or harvested;^P or

2. Approved for sale or service .^P

B. Molluscan shellfish that are recreationally caught shall not be received for sale or service.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-310 Molluscan shellfish

A. Molluscan shellfish shall be obtained from sources according to law and the requirements specified in the U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, National Shellfish Sanitation Program (NSSP) Guide for the Control of Molluscan Shellfish, 2017 Revision, (U.S. Food and Drug Administration).^P

B. Molluscan shellfish shall be from sources that are listed in the "Interstate Certified Shellfish Shippers List" (U.S. Food and Drug Administration).^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-320 Wild mushrooms

A. Except as specified in subsection B of this section, mushroom species picked in the wild shall not be offered for sale or service by a food establishment unless the food establishment has been approved to do so.^P

B. This section does not apply to:

1. Cultivated wild mushroom species that are grown, harvested, and processed in an operation that is regulated by the food regulatory agency that has jurisdiction over the operation; or

2. Wild mushroom species if they are in packaged form and are the product of a food processing plant that is regulated by the food regulatory agency that has jurisdiction over the plant.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-330 Game animals

A. If game animals are received for sale or service they shall be:

1. Commercially raised for food and raised, slaughtered, and processed under a voluntary inspection program that is conducted by the state agency that has animal health jurisdiction or under a voluntary inspection program administered by the USDA for game animals such as exotic animals (reindeer, elk, deer, antelope, water buffalo, or bison) that are "inspected and approved" in accordance with 9 CFR Part 352;

2. As allowed by law, wild game animals that are live-caught:

a. Under a routine inspection program conducted by a regulatory agency such as the agency that has animal health jurisdiction;^P

b. Slaughtered and processed according to:

(1) Laws governing meat and poultry as determined by the agency that has animal health jurisdiction and the agency that conducts the inspection program;^P and

(2) Requirements that are developed by the agency that has animal health jurisdiction and the agency that conducts the inspection program with consideration of factors such as the need for antemortem and postmortem examination by an approved veterinarian or veterinarian's designee;^P or

3. As allowed by law for field-dressed wild game animals under a routine inspection program that ensures the animals:

a. Receive a postmortem examination by an approved veterinarian or veterinarian's designee; or

b. Are field-dressed and transported according to requirements specified by the agency that has animal health jurisdiction and the agency that conducts the inspection program;^Pand

c. Are processed according to laws governing meat and poultry as determined by the agency that has animal health jurisdiction and the agency that conducts the inspection program.^P

B. A game animal shall not be received for sale or service if it is a species of wildlife that is listed in 50 CFR Part 17.

C. The requirements of subsection A of this section shall not apply to commercially slaughtered or processed rabbits that are offered for sale or service.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016; Volume 36, Issue 1, eff. October 17, 2019.

12VAC5-421-340 Temperature

A. Except as specified in subsection B of this section, refrigerated, time/temperature control for safety food shall be at a temperature of 41°F (5°C) or below when received.^P

B. If a temperature other than 41°F (5°C) for a time/temperature control for safety food is specified in law governing its distribution, such as laws governing milk and molluscan shellfish, the food may be received at the specified temperature.

C. Raw eggs shall be received in refrigerated equipment that maintains an ambient air temperature of 45°F (7°C) or less.^P

D. Time/temperature control for safety food that is cooked to a temperature and for a time specified under 12VAC5-421-700, 12VAC5-421-710, and 12VAC5-421-720 and received hot shall be at a temperature of 135° (57°C) or above.^P

E. A food that is labeled frozen and shipped frozen by a food processing plant shall be received frozen.^Pf

F. Upon receipt, time/temperature control for safety food shall be free of evidence of previous temperature abuse.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-350 Additives

Food shall not contain unapproved food additives or additives that exceed amounts specified in 21 CFR Parts 170-180 relating to food additives; generally recognized as safe (GRAS) or prior sanctioned substances that exceed amounts allowed in 21 CFR Parts 181-186; substances that exceed amounts specified in 9 CFR 424.21(b), Subpart C; or pesticide residues that exceed provisions specified in 40 CFR Part 180 and exceptions.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-360 Eggs

Eggs shall be received clean and sound and shall not exceed the restricted egg tolerances for U.S. Consumer Grade B as specified in United States Standards, Grades, and Weight Classes for Shell Eggs, AMS 56.200 et seq., administered by the Agricultural Marketing Service of USDA. Eggs sold pursuant to § 3.2-5305 of the Code of Virginia are exempt from the restricted egg tolerances for U.S. Consumer Grade B as specified in United States Standards, Grades, and Weight Classes for Shell Eggs, AMS 56, effective July 20, 2000, (Agricultural Marketing Service of USDA).^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-370 Eggs and milk products, pasteurized

A. Egg products shall be obtained pasteurized.^P

B. Fluid and dry milk and milk products shall:

1. Be obtained pasteurized;^P and

2. Comply with Grade A standards as specified in law.

C. Frozen milk products, such as ice cream, shall be obtained pasteurized in accordance with 21 CFR Part 135.^P

D. Cheese shall be obtained pasteurized unless alternative procedures to pasteurization are specified in the CFR, such as 21 CFR Part 133.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-380 Package integrity

Food packages shall be in good condition and protect the integrity of the contents so that the food is not exposed to adulteration or potential contaminants.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-390 Ice

Ice for use as a food or a cooling medium shall be made from pure water.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-400 Molluscan shellfish, packaging, and identification

A. Molluscan shellfish shall be obtained in nonreturnable packages or containers that bear a legible tag or label that identifies the:^Pf

1. Source, and is affixed by a dealer who depurates, packs, ships, or reships the molluscan shellfish, as specified in the National Shellfish Sanitation Program Guide for Control of Molluscan Shellfish, 2013 Revision;^Pf and

2. "Sell by" or "best if used by" date for shucked shellfish packages with a capacity of less than 64 fluid ounces (1.89L) or the date shucked for packages with a capacity of 64 fluid ounces (1.89L) or more.^Pf

B. A container of raw molluscan shellfish that does not bear a tag or label or that bears a tag or label that does not contain all the information as specified under subsection A of this section shall be subject to a hold order, as allowed by law, or seizure and destruction in accordance with 21 CFR 1240.60(d), Subpart D.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021; Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-410 Shellstock identification

A. Shellstock shall be obtained in containers bearing legible source identification tags or labels that are affixed by a dealer that depurates, ships, or reships the shellstock, as specified in the National Shellfish Sanitation Program (NSSP) Guide for the Control of Molluscan Shellfish, 2017 Revision (U.S. Food and Drug Administration), and that include the following information:^Pf

1. The dealer's name and address, and the certification number assigned by the shellfish control authority;^Pf

2. The original shipper's certification number assigned by the shellfish control authority.;^Pf

3. The harvest date, or if depurated, the date of depuration processing, or if wet stored, the original harvest date and the final harvest date;^Pf

4. If wet stored or depurated, the wet storage or depuration cycle or lot number. The wet storage lot number shall begin with the letter "w.";^Pf

5. The harvest area, including the initials of the state or, as applicable, country of harvest;^Pf

6. The type and quantity of shellstock;^Pf

7. The following statement in bold, capitalized type: "THIS TAG (OR LABEL) IS REQUIRED TO BE ATTACHED UNTIL CONTAINER IS EMPTY OR IS RETAGGED AND THEREAFTER KEPT ON FILE, IN CHRONOLOGICAL ORDER, FOR 90 DAYS." "RETAILERS: DATE WHEN LAST SHELLFISH FROM THIS CONTAINER SOLD OR SERVED (INSERT DATE)"^Pf; and

8. All shellstock intended for raw consumption shall include a consumer advisory using the statement from 12VAC5-421-930 C, or an equivalent statement.

B. A container of shellstock that does not bear a tag or label or that bears a tag or label that does not contain all the information as specified under subsection A of this section shall be subject to a hold order, as allowed by law, or seizure and destruction in accordance with 21 CFR 1240.60(d), Subpart D.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-420 Shellstock; condition

When received by a food establishment, shellstock shall be reasonably free of mud, dead shellstock, and shellstock with broken shells. Dead shellstock and shellstock with badly broken shells shall be discarded.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-430 Molluscan shellfish; original container

A. Except as specified in subsections C, D, and E of this section, molluscan shellfish may not be removed from the container in which they were received other than immediately before sale or preparation for service.

B. Molluscan shellfish from one tagged or labeled container may not be commingled with molluscan shellfish from another container with different certification numbers, different harvest dates, or different harvest areas identified on the tag or label before being ordered by the consumer.^Pf

C. For display purposes, shellstock or in-shell product may be removed from the container in which they are received, displayed on drained ice, or held in a display container, and a quantity specified by a consumer may be removed from the display or display container and provided to the consumer if:

1. The source of the shellstock or in-shell product on display is identified as specified under 12VAC5-421-400 and recorded as specified under 12VAC5-421-440; and

2. The shellstock or in-shell product are protected from contamination.

D. Shucked shellfish may be removed from the container in which they were received and held in a display container from which individual servings are dispensed upon a consumer's request if:

1. The labeling information for the shellfish on display as specified under 12VAC5-421-400 is retained and correlated to the date when, or dates during which, the shellfish are sold or served; and

2. The shellfish are protected from contamination.

E. Shucked shellfish may be removed from the container in which they were received and repacked in consumer self-service containers where allowed by law if:

1. The labeling information for the shellfish is on each consumer self-service container as specified under 12VAC5-421-400 and 12VAC5-421-900 A and B 1 through B 5;

2. The labeling information as specified under 12VAC5-421-400 is retained and correlated with the date when, or dates during which, the shellfish are sold or served;

3. The labeling information and dates specified under subdivision 2 of this subsection are maintained for 90 days; and

4. The shellfish are protected from contamination.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016; Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-440 Molluscan shellfish; maintain identification

A. Except as specified under subdivision C 2 of this section, molluscan shellfish tags or labels shall remain attached to the container in which the shellstock are received until the container is empty.^Pf

B. The date when the last molluscan shellfish from the container is sold or served shall be recorded on the tag, label, or invoice.^Pf

C. The identity of the source of molluscan shellfish that are sold or served shall be maintained by retaining product tags, labels, or invoices for 90 calendar days from the date that is recorded on the tag, label, or invoice as specified in subsection B of this section, by:^Pf

1. Using an approved recordkeeping system that keeps the tags, labels, or invoices in chronological order correlated to the date that is recorded on the tag, label, or invoice as specified under subsection B of this section;^Pf and

2. If shellstock, shucked shellfish, or in-shell product are removed from the tagged or labeled container:

a. Preserving source identification by using a recordkeeping system as specified under subdivision C 1 of this section;^Pf and

b. Ensuring that shellstock, shucked shellfish, or in-shell product from one tagged or labeled container are not commingled with shellstock, shucked shellfish, or in-shell product from another container with different certification numbers, different harvest dates, or different growing areas as identified on the tag or label before being ordered by the consumer.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021; Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-445 Food donation

Food that is stored, prepared, packaged, displayed, and labeled in accordance to law and this chapter may be offered for donation.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 42, Issue 25, eff. September 10, 2026.

Article 3 Protection from Contamination after Receiving

12VAC5-421-450 Preventing contamination from hands

A. Food employees shall wash their hands as specified under 12VAC5-421-140.

B. Except when washing fruits and vegetables as specified under 12VAC5-421-510 or as specified in subsections D and E of this section, food employees shall not contact exposed, ready-to-eat food with their bare hands and shall use suitable utensils such as deli tissue, spatulas, tongs, single-use gloves, or dispensing equipment.^P

C. Food employees shall minimize bare hand and arm contact with exposed food that is not in a ready-to-eat form.^Pf

D. Subsection B of this section does not apply to a food employee who contacts exposed, ready-to-eat food with bare hands at the time the ready-to-eat food is being added as an ingredient to food that:

1. Contains a raw animal food and is to be cooked in the food establishment to heat all parts of the food to the minimum temperatures specified in subsection A or B of 12VAC5-421-700 or in 12VAC5-421-710; or

2. Does not contain a raw animal food but is to be cooked in the food establishment to heat all parts of the food to a temperature of at least 145°F (63°C).

E. Food employees not serving a highly susceptible population may contact exposed, ready-to-eat food with their bare hands if:

1. The permit holder obtains prior approval from the department;

2. Written procedures are maintained in the food establishment and made available to the department upon request that include:

a. For each bare hand contact procedure, a listing of the specific ready-to-eat foods that are touched by bare hands;

b. Diagrams and other information showing that handwashing facilities, installed, located, equipped, and maintained as specified under 12VAC5-421-2230, 12VAC5-421-2280, 12VAC5-421-2310, 12VAC5-421-3020, 12VAC5-421-3030, and 12VAC5-421-3045 are in an easily accessible location and in close proximity to the work station where the bare hand contact procedure is conducted;

3. A written employee health policy that details how the food establishment complies with 12VAC5-421-80, 12VAC5-421-90, and 12VAC5-421-100 including:

a. Documentation that the food employees and conditional employees acknowledge that they are informed to report information about their health and activities as they relate to gastrointestinal symptoms and diseases that are transmittable through food as specified under 12VAC5-421-80 A;

b. Documentation that food employees and conditional employees acknowledge their responsibilities as specified under 12VAC5-421-80 E and F; and

c. Documentation that the person in charge acknowledges the responsibilities as specified under 12VAC5-421-80 B, C, and D, and 12VAC5-421-90 and 12VAC5-421-100;

4. Documentation that the food employees acknowledge that they have received training in:

a. The risks of contacting the specific ready-to-eat foods with their bare hands;

b. Proper handwashing as specified under 12VAC5-421-140;

c. When to wash their hands as specified under 12VAC5-421-160;

d. Where to wash their hands as specified under 12VAC5-421-170;

e. Proper fingernail maintenance as specified under 12VAC5-421-190;

f. Prohibition of jewelry as specified under 12VAC5-421-200; and

g. Good hygienic practices as specified under 12VAC5-421-220 and 12VAC5-421-230;

5. Documentation that hands are washed before food preparation and as necessary to prevent cross-contamination by food employees as specified under 12VAC5-421-130 through 12VAC5-421-170 during all hours of operation when the specific ready-to-eat foods are prepared;

6. Documentation that food employees contacting ready-to-eat food with bare hands use two or more of the following control measures to provide additional safeguards to hazards associated with bare hand contact:

a. Double handwashing;

b. Nail brushes;

c. A hand antiseptic after handwashing as specified under 12VAC5-421-180;

d. Incentive programs such as paid sick leave that assist or encourage food employees not to work when they are ill; or

e. Other control measures approved by the department; and

7. Documentation that corrective action is taken when subdivisions 1 through 6 of this subsection are not followed.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-460 Preventing contamination when tasting

A food employee shall not use a utensil more than once to taste food that is to be sold or served.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia
• Historical Notes: Derived from Virginia Register Volume 24, Issue 2, eff. October 16, 2007; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-470 Packaged and unpackaged food - separation, packaging, and segregation

A. Food shall be protected from cross-contamination by:

1. Except as specified in subdivision 1 d of this subsection, or if combined as ingredients, separating raw animal foods during storage, preparation, holding, and display from:

a. Raw ready-to-eat food, including other raw animal food such as fish for sushi or molluscan shellfish, or other raw ready-to-eat food such as fruits and vegetables;^P

b. Cooked ready-to-eat food;^P

c. Fruits and vegetables before they are washed;^P and

d. Frozen, commercially processed, and packaged raw animal food may be stored or displayed with or above frozen, commercially processed and packaged, ready-to-eat food;

2. Except if combined as ingredients, separating types of raw animal foods from each other such as beef, fish, lamb, pork, and poultry during storage, preparation, holding, and display by:

a. Using separate equipment for each type;^P or

b. Arranging each type of food in equipment so that cross contamination of one type with another is prevented;^P and

c. Preparing each type of food at different times or in separate areas.^P

3. Cleaning equipment and utensils as specified under 12VAC5-421-1780 A and sanitizing as specified under 12VAC5-421-1900;

4. Except as specified in subsection B of this section and 12VAC5-421-810 B 2, storing the food in packages, covered containers, or wrappings;

5. Cleaning hermetically sealed containers of food of visible soil before opening;

6. Protecting food containers that are received packaged together in a case or overwrap from cuts when the case or overwrap is opened;

7. Storing damaged, spoiled, or recalled food being held in the food establishment as specified under 12VAC5-421-3150; and

8. Separating fruits and vegetables, before they are washed as specified under 12VAC5-421-510 from ready-to-eat food.

B. Subdivision A 4 of this section shall not apply to:

1. Whole, uncut, raw fruits and vegetables and nuts in the shell that require peeling or hulling before consumption;

2. Primal cuts, quarters, or sides of raw meat or slab bacon that are hung on clean, sanitized hooks or placed on clean, sanitized racks;

3. Whole, uncut, processed meats such as country hams, and smoked or cured sausages that are placed on clean, sanitized racks;

4. Food being cooled as specified under 12VAC5-421-810 B 2; or

5. Shellstock.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021; Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-480 Food storage containers; identified with common name of food

Except for containers holding food that can be readily and unmistakably recognized such as dry pasta, working containers holding food or food ingredients that are removed from their original packages for use in the food establishment, such as cooking oils, flour, herbs, potato flakes, salt, spices, and sugar shall be identified with the common name of the food.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-490 Pasteurized eggs; substitute for raw eggs for certain recipes and populations

Pasteurized eggs or egg products shall be substituted for raw eggs in the preparation of foods such as Caesar salad, hollandaise or béarnaise sauce, mayonnaise, meringue, eggnog, ice cream, and egg-fortified beverages that are not:^P

1. Cooked as specified in 12VAC5-421-700 A 1 or 2;^P or

2. Included in 12VAC5-421-700 D.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-500 Protection from unapproved additives

A. Food, as specified in 12VAC5-421-350, shall be protected from contamination that may result from the addition of:

1. Unsafe or unapproved food or color additives;^P and

2. Unsafe or unapproved levels of approved food and color additives.^P

B. A food employee shall not:

1. Apply sulfiting agents to fresh fruits and vegetables intended for raw consumption or to a food considered to be a good source of vitamin B₁;^P or

2. Except for grapes, serve or sell food specified under subdivision B 1 of this section that is treated with sulfiting agents before receipt by the food establishment.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-510 Washing fruits and vegetables

A. Except as specified in subsection B of this section and except for whole, raw fruits and vegetables that are intended for washing by the consumer before consumption, raw fruits and vegetables shall be thoroughly washed in water to remove soil and other contaminants before being cut, combined with other ingredients, cooked, served, or offered for human consumption in ready-to-eat form.

B. Fruits and vegetables may be washed by using chemicals as specified under 12VAC5-421-3390 and a test kit or other device that accurately measures the active ingredient concentration of the fruit and vegetable wash solution may be provided.

C. A device used for onsite generation of chemicals meeting the requirements specified in 21 CFR 173.315 shall be used in accordance with the manufacturer's instructions.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016; Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-520 Ice used as exterior coolant, prohibited as ingredient

After use as a medium for cooling the exterior surfaces of food such as melons or fish, packaged foods such as canned beverages, or cooling coils and tubes of equipment, ice shall not be used as food.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-530 Storage or display of food in contact with water or ice

A. Packaged food shall not be stored in direct contact with ice or water if the food is subject to the entry of water because of the nature of its packaging, wrapping, or container or its positioning in the ice or water.

B. Except as specified in subsections C and D of this section, unpackaged food shall not be stored in direct contact with undrained ice.

C. Whole, raw fruits or vegetables; cut, raw vegetables such as celery or carrot sticks or cut potatoes; and tofu may be immersed in ice or water.

D. Raw chicken and raw fish that are received immersed in ice in shipping containers may remain in that condition while in storage awaiting preparation, display, service, or sale.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007.

12VAC5-421-540 Food contact with equipment and utensils

Food shall only contact surfaces of:

1. Equipment and utensils that are cleaned as specified under 12VAC5-421-1770 through 12VAC5-421-1860 and sanitized as specified under 12VAC5-421-1885, 12VAC5-421-1890 and 12VAC5-421-1900;^P

2. Single-service and single-use articles;^P or

3. Linens, such as cloth napkins, as specified under 12VAC5-421-560 that are laundered as specified under 12VAC5-421-1920 C.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-550 In-use utensils, between-use storage

During pauses in food preparation or dispensing, food preparation and dispensing utensils shall be stored:

1. Except as specified under subdivision 2 of this section, in the food with their handles above the top of the food and the container;

2. In food that is not time/temperature control for safety food with their handles above the top of the food within containers or equipment that can be closed, such as bins of sugar, flour, or cinnamon;

3. On a clean portion of the food preparation table or cooking equipment only if the in-use utensil and the food-contact surface of the food preparation table or cooking equipment are cleaned and sanitized at a frequency specified under 12VAC5-421-1780 and 12VAC5-421-1890;

4. In running water of sufficient velocity to flush particulates to the drain, if used with moist food such as ice cream or mashed potatoes;

5. In a clean, protected location if the utensils, such as ice scoops, are used only with a food that is not time/temperature control for safety food; or

6. In a container of water if the water is maintained at a temperature of at least 135°F (57°C) and the container is cleaned at a frequency specified under 12VAC5-421-1780 D 7.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-560 Linens and napkins, use limitation

Linens, such as cloth napkins, shall not be used in contact with food unless they are used to line a container for the service of foods and the linens and napkins are replaced each time the container is refilled for a new customer.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-570 Wiping cloths; use limitation

A. Cloths in-use for wiping food spills from tableware and carry-out containers that occur as food is being served shall be:

1. Maintained dry; and

2. Used for no other purpose.

B. Cloths in-use for wiping counters and other equipment surfaces shall be:

1. Held between uses in a chemical sanitizer solution at a concentration specified in 12VAC5-421-3380; and

2. Laundered daily as specified under 12VAC5-421-1920 D.

C. Cloths in-use for wiping surfaces in contact with raw animal foods shall be kept separate from other cloths used for other purposes.

D. Dry wiping cloths and the chemical sanitizing solutions specified in subdivision B 1 of this section in which wet wiping cloths are held between uses shall be free of food debris and visible soil.

E. Containers of chemical sanitizing solutions specified in subdivision B 1 of this section in which wet wiping cloths are held between uses shall be stored off the floor and used in a manner that prevents contamination of food, equipment, utensils, linens, single-service, or single-use articles.

F. Single-use disposable sanitizer wipes shall be used in accordance with EPA-approved manufacturer's label use instructions.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-580 Gloves; use limitation

A. If used, single-use gloves shall be used for only one task such as working with ready-to-eat food or with raw animal food, used for no other purpose, and discarded when damaged or soiled, or when interruptions occur in the operation.^P

B. Except as specified in subsection C of this section, slash-resistant gloves that are used to protect the hands during operations requiring cutting shall be used in direct contact only with food that is subsequently cooked as specified under 12VAC5-421-700 through 12VAC5-421-760 such as frozen food or a primal cut of meat.

C. Slash-resistant gloves may be used with ready-to-eat food that will not be subsequently cooked if the slash-resistant gloves have a smooth, durable, and nonabsorbent outer surface; or if the slash-resistant gloves are covered with a smooth, durable, nonabsorbent glove, or a single-use glove.

D. Cloth gloves shall not be used in direct contact with food unless the food is subsequently cooked as required under 12VAC5-421-700 through 12VAC5-421-760 such as frozen food or a primal cut of meat.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-590 Using clean tableware for second portions and refills

A. Except for refilling a consumer's drinking cup or container without contact between the pouring utensil and the lip contact area of the drinking cup or container, food employees shall not use tableware, including single-service articles, soiled by the consumer to provide second portions or refills.

B. Except as specified in subsection C of this section, self-service consumers shall not be allowed to use soiled tableware, including single-service articles, to obtain additional food from the display and serving equipment.

C. Cups and glasses may be reused by self-service consumers or food employees if refilling is a contamination-free process as specified under subdivisions 1, 2 and 4 of 12VAC5-421-1230.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007.

12VAC5-421-600 Refilling returnables

A. Except as specified in subsections B through E of this section, empty containers returned to a food establishment for cleaning and refilling with food shall be cleaned and refilled in a regulated food processing plant.^P

B. A take-home food container returned to a food establishment may be refilled at a food establishment with food if the food container is:

1. Designed and constructed for reuse and in accordance with the requirements specified in 12VAC5-421-960 through 12VAC5-421-1435;^P

2. One that was initially provided by the food establishment to the consumer, either empty or filled with food by the establishment, for the purpose of being returned for reuse;

3. Returned to the food establishment by the consumer after use;

4. Subject to the following steps before being refilled with food:

a. Cleaned as specified in 12VAC5-421-1770 through 12VAC5-421-1860;

b. Sanitized as specified in 12VAC5-421-1885, 12VAC5-421-1890, and 12VAC5-421-1900;^Pand

c. Visually inspected by a food employee to verify that the container, as returned, meets the requirements specified in 12VAC5-421-960 through 12VAC5-421-1435.^P

C. A take-home food container returned to a food establishment may be refilled at a food establishment with beverage if:

1. The beverage is not a time/temperature control for safety food;

2. The design of the container, the rinsing equipment, and the nature of the beverage, when considered together, allow effective cleaning at home or in the food establishment;

3. Facilities before rinsing or refilling returned containers with fresh, hot water that is under pressure and not recirculated are provided as part of the dispensing system;

4. The consumer-owned container returned to the food establishment for refilling is refilled for sale or service only to the same consumer; and

5. The container is refilled by:

a. An employee of the food establishment; or

b. The owner of the container if the beverage system includes a contamination-free transfer process as specified in subdivisions 1, 2, and 4 of 12VAC5-421-1230.

D. Consumer-owned, personal take-out beverage containers, such as thermally insulated bottles, nonspill coffee cups, and promotional beverage glasses, may be refilled by employees or the consumer if refilling is a contamination-free process as specified under subdivisions 1, 2, and 4 of 12VAC5-421-1230.

E. Consumer-owned containers that are not food-specific may be filled at a water vending machine or system.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-610 Food storage

A. Except as specified in subsections B and C of this section, food shall be protected from contamination by storing the food:

1. In a clean, dry location;

2. Where it is not exposed to splash, dust, or other contamination; and

3. At least 6 inches (15 cm) above the floor.

B. Food in packages and working containers may be stored less than 6 inches (15 cm) above the floor on case lot handling equipment as specified under 12VAC5-421-1420.

C. Pressurized beverage containers, cased food in waterproof containers such as bottles or cans, and milk containers in plastic crates may be stored on a floor that is clean and not exposed to floor moisture.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-620 Food storage; prohibited areas

Food shall not be stored:

1. In locker rooms;

2. In toilet rooms or their vestibules;^Pf

3. In dressing rooms;

4. In garbage rooms;

5. In mechanical rooms;

6. Under sewer lines that are not shielded to intercept potential drips;

7. Under leaking water lines, including leaking automatic fire sprinkler heads, or under lines on which water has condensed;

8. Under open stairwells; or

9. Under other sources of contamination.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-630 Vended time/temperature control for safety food; original container

Time/temperature control for safety food dispensed through a vending machine shall be in the package in which it was placed at the food establishment or food processing plant at which it was prepared.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-640 Food preparation

During preparation, unpackaged food shall be protected from environmental sources of contamination.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-650 Food display

Except for nuts in the shell and whole, raw fruits and vegetables that are intended for hulling, peeling, or washing by the consumer before consumption, food on display shall be protected from contamination by the use of packaging; counter, service line, or salad bar food guards; display cases; or other effective means.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-660 Condiments; protection

A. Condiments shall be protected from contamination by being kept in dispensers that are designed to provide protection, protected food displays provided with the proper utensils, original containers designed for dispensing, or individual packages or portions.

B. Condiments at a vending machine location shall be in individual packages or provided in dispensers that are filled at a location that is approved by the department, such as the food establishment that provides food to the vending machine location, a food processing plant that is regulated by the agency that has jurisdiction over the operation, or a properly equipped facility that is located on the site of the vending machine location.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-670 Consumer self-service operations

A. Raw, unpackaged animal food, such as beef, lamb, pork, poultry, and fish shall not be offered for consumer self-service.^P This subsection does not apply to:

1. Consumer self-service of ready-to-eat foods at buffets or salad bars that serve foods such as sushi or raw shellfish;

2. Ready-to-cook individual portions for immediate cooking and consumption on the premises such as consumer-cooked meats or consumer-selected ingredients for Mongolian barbecue; or

3. Raw, frozen, shell-on shrimp or lobster.

B. Consumer self-service operations for ready-to-eat foods shall be provided with suitable utensils or effective dispensing methods that protect the food from contamination.^Pf

C. Consumer self-service operations such as buffets and salad bars shall be monitored by food employees trained in safe operating procedures.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-680 Returned food and reservice of food

A. Except as specified under subsection B of this section, after being served or sold and in the possession of a consumer, food that is unused or returned by the consumer shall not be offered as food for human consumption.^P

B. Except as specified in subdivision 8 of 12VAC5-421-950, a container of food that is not time/temperature control for safety food may be re-served from one consumer to another if:

1. The food is dispensed so that it is protected from contamination and the container is closed between uses such as a narrow-neck bottle containing catsup, steak sauce, or wine; or

2. The food, such as crackers, salt, or pepper, is in an unopened original package and maintained in sound condition.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-690 Miscellaneous sources of contamination

Food shall be protected from contamination that may result from a factor or source not specified under 12VAC5-421-450 through 12VAC5-421-680.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

Article 4 Destruction of Organisms of Public Health Concern

12VAC5-421-700 Raw animal foods

A. Except as specified in subsections B, C, and D of this section, raw animal foods such as eggs, fish, meat, poultry, and foods containing these raw animal foods shall be cooked to heat all parts of the food to a temperature and for a time that complies with one of the following methods based on the food that is being cooked:

1. 145°F (63°C) or above for 15 seconds for:^P

a. Raw eggs that are broken and prepared in response to a consumer's order and for immediate service;^P and

b. Unless otherwise specified in subdivisions A 2 and A 3 and subsections B and C of this section, fish and intact meat, including game animals commercially raised for food and game animals under a voluntary inspection program as specified under 12VAC5-421-330 A 1;^P

2. 155°F (68°C) for 17 seconds or the temperature specified in the table in this subdivision that corresponds to the holding time for ratites and nonintact meats; comminuted fish, game animals commercially raised for food, and game animals under a voluntary inspection program as specified under 12VAC5-421-330 A 1; and raw eggs that are not prepared as specified under subdivision 1 a of this subsection:^P

| Minimum | | | --- | --- | | Temperature °F (°C) | Time | | 145 (63) | 3 minutes | | 150 (66) | 1 minute | | 158 (70) | <1 second (instantaneous) |

; or

3. 165°F (74°C) or above for less than one second (instantaneous) for poultry; baluts; wild game animals as specified under 12VAC5-421-330 A 2; stuffed fish; stuffed meat; stuffed pasta; stuffed poultry; stuffed ratites; or stuffing containing fish, meat, poultry, or ratites.^P

B. Whole meat roasts, including beef, corned beef, lamb, pork, and cured pork roasts such as ham shall be cooked:

1. As specified in the table in this subdivision, to heat all parts of the food to a temperature and for the holding time that corresponds to that temperature:^P

| Temperature °F (°C) | Time¹in Minutes | Temperature °F (°C) | Time¹in Seconds | | --- | --- | --- | --- | | 130 (54.4) | 112 | 147 (63.9) | 134 | | 131 (55.0) | 89 | 149 (65.0) | 85 | | 133 (56.1) | 56 | 151 (66.1) | 54 | | 135 (57.2) | 36 | 153 (67.2) | 34 | | 136 (57.8) | 28 | 155 (68.3) | 22 | | 138 (58.9) | 18 | 157 (69.4) | 14 | | 140 (60.0) | 12 | 158 (70.0) | 0 | | 142 (61.1) | 8 | | | | 144 (62.2) | 5 | | | | 145 (62.8) | 4 | | | | ¹Holding time may include postoven heat rise. | | | |

; and

2. If cooked in an oven, using an oven that is preheated to the temperature specified for the roast's weight in the table in this subdivision and that is held at that temperature.^Pf

| Oven Type | Oven Temperature Based on Roast Weight | | | --- | --- | --- | | | Less than 10 lbs (4.5 kg) | 10 lbs (4.5 kg) or more | | Still Dry | 350°F (177°C) or more | 250°F (121°C) or more | | Convection | 325°F (163°C) or more | 250°F (121°C) or more | | High Humidity¹ | 250°F (121°C) or less | 250°F (121°C) or less | | ¹Relative humidity greater than 90% for at least one hour as measured in the cooking chamber or exit of the oven; or in a moisture-impermeable bag that provides 100% humidity. | | |

C. A raw or undercooked whole-muscle, intact beef steak may be served or offered for sale in a ready-to-eat form if:

1. The food establishment serves a population that is not a highly susceptible population;

2. The steak is prepared so that it remains intact; and

3. The steak is cooked on both the top and bottom to a surface temperature of 145°F (63°C) or above and a cooked color change is achieved on all external surfaces.

D. A raw animal food such as raw egg, raw fish, raw-marinated fish, raw molluscan shellfish, or steak tartare, or a partially cooked food such as lightly cooked fish, soft cooked eggs, or rare meat other than whole-muscle, intact beef steaks as specified in subsection C of this section, may be served or offered for sale upon request or consumer selection in a ready-to-eat form if:

1. Pursuant to subdivisions 3 a and 3 b of 12VAC5-421-950, the food establishment serves a population that is not a highly susceptible population; the food, if served or offered for service by consumer selection from a children's menu, does not contain comminuted meat;^Pf and the consumer is informed, pursuant to 12VAC5-421-930, that to ensure its safety, the food should be cooked as specified under subsection A or B of this section; or

2. The department grants a variance from subsection A or B of this section pursuant to 12VAC5-421-3570 based on a HACCP plan that:

a. Is submitted by the permit holder and approved pursuant to 12VAC5-421-3570;

b. Documents scientific data or other information that shows that a lesser time and temperature regimen results in a safe food; and

c. Verifies that equipment and procedures for food preparation and training of food employees at the food establishment meet the conditions of the variance.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021; Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-710 Microwave cooking

Raw animal foods cooked in a microwave oven shall be:

1. Rotated or stirred throughout or midway during cooking to compensate for uneven distribution of heat;

2. Covered to retain surface moisture;

3. Heated to a temperature of at least 165°F (74°C) in all parts of the food;^P and

4. Allowed to stand covered for two minutes after cooking to obtain temperature equilibrium.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-720 Plant food cooking for hot holding

Plant foods that are cooked for hot holding shall be cooked to a temperature of 135°F (57°C).^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-725 Noncontinuous cooking

Raw animal foods that are cooked using a noncontinuous cooking process shall be:

1. Subject to an initial heating process that is no longer than 60 minutes in duration;^P

2. Immediately after initial heating, cooled according to the time and temperature requirements specified for cooked time/temperature control for safety food under 12VAC5-421-800 A;^P

3. After cooling, held frozen or cold, as specified for time/temperature control for safety food under 12VAC5-421-820 A 2;^P

4. Prior to sale or service, cooked using a process that heats all parts of the food to a temperature and for a time as designated in 12VAC5-421-700 A, B, and C;^P

5. Cooled according to the time and temperature parameters specified for cooked time/temperature control for safety food under 12VAC5-421-800 A if not either hot held as specified under 12VAC5-421-820 A 1, served immediately, or held using time as a public health control as specified under 12VAC5-421-850 after complete cooling;^P and

6. Prepared and stored according to written procedures that:

a. Have obtained prior approval from the department;^Pf

b. Are maintained in the food establishment and are made available to the department upon request;^Pf

c. Describe how the requirements specified under subdivisions 1 through 5 of this section are to be monitored and documented by the permit holder and the corrective actions to be taken if the requirements are not met;^Pf

d. Describe how the foods, after initial heating, but prior to complete cooking, are to be marked or otherwise identified as foods that must be cooked as specified under subdivision 4 of this section prior to being offered for sale or service;^Pf and

e. Describe how the foods, after initial heating but prior to cooking as specified in subdivision 4 of this section, are to be separated from ready-to-eat foods as specified under 12VAC5-421-470 A.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 22, eff. July 12, 2016; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-726 Manufacturer cooking instructions

A. Commercially packaged food that bears a manufacturer's cooking instructions shall be cooked according to those instructions before being used in ready-to-eat foods or offered in unpackaged form for human consumption, unless the manufacturer’s instructions specify that the food may be consumed without cooking.^P

B. Food for which the manufacturer has provided information that it has not been processed to control pathogens, when used in ready-to-eat foods or offered for human consumption, shall be cooked according to a time and temperature appropriate for the food.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-730 Parasite destruction

A. Except as specified in subsection B of this section, before service or sale in ready-to-eat form, raw, raw-marinated, partially cooked or marinated-partially cooked fish shall be:

1. Frozen and stored at a temperature of -4°F (-20°C) or below for a minimum of 168 hours (seven days) in a freezer;^P

2. Frozen at -31°F (-35°C) or below until solid and stored at -31°F (-35°C) or below for a minimum of 15 hours;^P or

3. Frozen at -31°F (-35°C) or below until solid and stored at -4°F (-20°C) or below for a minimum of 24 hours.^P

B. Subsection A of this section does not apply to:

1. Molluscan shellfish;

2. A scallop product consisting only of the shucked adductor muscle;

3. Tuna of the species Thunnus alalunga, Thunnus albacares (Yellowfin tuna), Thunnus atlanticus, Thunnus maccoyii (Bluefin tuna, Southern), Thunnus obesus (Bigeye tuna), or Thunnus thynnus (Bluefin tuna, Northern);

4. Aquacultured fish, such as salmon, that:

a. If raised in open water, are raised in net-pens; or

b. Are raised in land-based operations such as ponds or tanks; and

c. Are fed formulated feed, such as pellets, that contains no live parasites infective to the aquacultured fish, or

5. Fish eggs that have been removed from the skein and rinsed.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-740 Records, creation and retention

A. Except as specified in 12VAC5-421-730 B and subsection B of this section, if raw, raw-marinated, partially cooked, or marinated-partially cooked fish are served or sold in ready-to-eat form, the person in charge shall record the freezing temperature and time to which the fish are subjected and shall retain the records at the food establishment for 90 calendar days beyond the time of service or sale of the fish.^Pf

B. If the fish are frozen by a supplier, a written agreement or statement from the supplier stipulating that the fish supplied are frozen to a temperature and for a time specified under 12VAC5-421-730 may substitute for the records specified under subsection A of this section.

C. If raw, raw-marinated, partially cooked, or marinated-partially cooked fish are served or sold in ready-to-eat form, and the fish are raised and fed as specified in 12VAC5-421-730 B 4, a written agreement or statement from the supplier or aquaculturist stipulating that the fish were raised and fed as specified in 12VAC5-421-730 B 4 shall be obtained by the person in charge and retained in the records of the food establishment for 90 calendar days beyond the time of service or sale of the fish.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-750 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; repealed, Virginia Register Volume 26, Issue 7, eff. January 1, 2010.

12VAC5-421-755 Preparation for immediate service

Cooked and refrigerated food that is prepared for immediate service in response to an individual consumer order, such as a roast beef sandwich au jus, may be served at any temperature.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-760 Reheating for hot holding

A. Except as specified under subsections B, C, and E of this section, time/temperature control for safety food that is cooked, cooled, and reheated for hot holding shall be reheated so that all parts of the food reach at least 165°F (74°C) for 15 seconds.^P

B. Except as specified under subsection C of this section, time/temperature control for safety food reheated in a microwave oven for hot holding shall be reheated so that all parts of the food reach a temperature of at least 165°F (74°C) and the food is rotated or stirred, covered, and allowed to stand covered two minutes after reheating.^P

C. Ready-to-eat time/temperature control for safety food that has been commercially processed and packaged in a food processing plant that is inspected by the department that has jurisdiction over the plant shall be heated to a temperature of at least 135°F (57°C) when being reheated for hot holding.^P

D. Reheating for hot holding as specified under subsections A, B, and C of this section shall be done rapidly and the time the food is between 41°F (5°C) and the temperatures specified under subsections A, B, and C of this section may not exceed two hours.^P

E. Remaining unsliced portions of meat roasts that are cooked as specified under 12VAC5-421-700 B may be reheated for hot holding using the oven parameters and minimum time and temperature conditions specified under 12VAC5-421-700 B.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

Article 5 Limitation of Growth of Organisms of Public Health Concern

12VAC5-421-765 Treating juice

Juice packaged in a food establishment shall be:

1. Treated under a HACCP plan as specified in 12VAC5-421-3630 to attain a five-log reduction, which is equal to a 99.999% reduction, of the most resistant microorganism of public health significance;^P or

2. Labeled, if not treated to yield a five-log reduction of the most resistant microorganism of public health significance:^Pf

a. As specified under 12VAC5-421-900;^Pf and

b. As specified in 21 CFR 101.17(g) with the following, "WARNING: This product has not been pasteurized and, therefore, may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems."^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 2, eff. October 16, 2007; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-770 Frozen food

Stored frozen foods shall be maintained frozen.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-780 Time/temperature control for safety food, slacking

Frozen time/temperature control for safety food that is slacked to moderate the temperature shall be held:

1. Under refrigeration that maintains the food temperature at 41°F (5°C) or less; or

2. At any temperature if the food remains frozen.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-790 Thawing

A. Except as specified in subdivision 4 of this subsection, time/temperature control for safety food shall be thawed:

1. Under refrigeration that maintains the food temperature at 41°F (5°C) or less;^Pf

2. Completely submerged under running water:

a. At a water temperature of 70°F (21°C) or below;^Pf

b. With sufficient water velocity to agitate and float off loose particles in an overflow;^Pf and

c. For a period of time that does not allow thawed portions of ready-to-eat food to rise above 41°F (5°C);^Pfor

d. For a period of time that does not allow thawed portions of a raw animal food requiring cooking pursuant to 12VAC5-421-700 A or B to be above 41°F (5°C) for more than four hours including:

(1) The time the food is exposed to the running water and the time needed for preparation for cooking;^Pf or

(2) The time it takes under refrigeration to lower the food temperature to 41°F (5°C);^Pf

3. As part of a cooking process if the food that is frozen is:

a. Cooked pursuant to 12VAC5-421-700 A or B, 12VAC5-421-710, or 12VAC5-421-726;^Pf or

b. Thawed in a microwave oven and immediately transferred to conventional cooking equipment, with no interruption in the process;^Pf or

4. Using any procedure if a portion of frozen ready-to-eat food is thawed and prepared for immediate service in response to an individual consumer's order.

B. Reduced oxygen packaged fish that bears a label indicating that it is to be kept frozen until time of use shall be removed from the reduced oxygen environment:

1. Before thawing under refrigeration pursuant to subdivision A 1 of this section.

2. Before or immediately upon completion of thawing using procedures specified in subdivision A 2 of this section.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016; Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-800 Cooling

A. Cooked time/temperature control for safety food shall be cooled:

1. Within two hours, from 135°F (57°C) to 70°F (21°C);^P and

2. Within a total of six hours from 135°F (57°C) to 41°F (5°C) or less.^P

B. Time/temperature control for safety food shall be cooled within four hours to 41°F (5°C) or less if prepared from ingredients at ambient temperature, such as reconstituted foods and canned tuna.^P

C. Except as specified in subsection D of this section, a time/temperature control for safety food received in compliance with laws allowing a temperature above 41°F (5°C) during shipment from the supplier as specified in 12VAC5-421-340 B, shall be cooled within four hours to 41°F (5°C) or less.^P

D. Raw eggs shall be received as specified under 12VAC5-421-340 C and immediately placed in refrigerated equipment that maintains an ambient air temperature of 45°F (7°C) or less.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-810 Cooling methods

A. Cooling shall be accomplished in accordance with the time and temperature criteria specified under 12VAC5-421-800 by using one or more of the following methods based on the type of food being cooled:

1. Placing the food in shallow pans;^Pf

2. Separating the food into smaller or thinner portions;^Pf

3. Using rapid cooling equipment;^Pf

4. Stirring the food in a container placed in an ice water bath;^Pf

5. Using containers that facilitate heat transfer;^Pf

6. Adding ice as an ingredient;^Pf or

7. Other effective methods.^Pf

B. When placed in cooling or cold holding equipment, food containers in which food is being cooled shall be:

1. Arranged in the equipment to provide maximum heat transfer through the container walls; and

2. Loosely covered, or uncovered if protected from overhead contamination as specified under 12VAC5-421-610 A 2, during the cooling period to facilitate heat transfer from the surface of the food.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-820 Time/temperature control for safety food; hot and cold holding

A. Except during preparation, cooking, or cooling, or when time is used as the public health control as specified under 12VAC5-421-850 and except as specified in subsections B and C of this section, time/temperature control for safety food shall be maintained:

1. At 135°F (57°C) or above, except that roasts cooked to a temperature and for a time specified under 12VAC5-421-700 B or reheated as specified in 12VAC5-421-760 E may be held at a temperature of 130°F (54°C) or above;^P or

2. At 41°F (5°C) or less.^P

B. Eggs that have not been treated to destroy all viable Salmonellae shall be stored in refrigerated equipment that maintains an ambient air temperature of 45°F (7°C) or less.^P

C. Time/temperature control for safety food in a homogenous liquid form may be maintained outside the temperature control requirements, as specified in subsection A of this section, while contained within specially designed equipment that complies with the design and construction requirements as specified under subdivision 5 of 12VAC5-421-1230.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-830 Ready-to-eat, time/temperature control for safety food; date marking

A. Except if packaging food using a reduced oxygen packaging method pursuant to 12VAC5-421-870, and except as specified in subsection E of this section, refrigerated ready-to-eat time/temperature control for safety food that is prepared and held in a food establishment for more than 24 hours shall be clearly marked to indicate the date or day by which the food shall be consumed on the premises, sold, or discarded if held at a temperature at or below 41°F (5°C) for a maximum of seven days. The day of preparation shall be counted as day one.^Pf

B. Except as specified in subsections E and F of this section, refrigerated ready-to-eat, time/temperature control for safety food that is prepared and packaged by a food processing plant shall be clearly marked at the time the original container is opened in a food establishment. If the food is held for more than 24 hours, the date marking shall indicate the date or day by which the food shall be consumed on the premises, sold, or discarded, based on the temperature and time combinations specified in subsection A of this section and:^Pf

1. The day the original container is opened in the food establishment shall be counted as day one;^Pf and

2. The day or date marked by the food establishment shall not exceed a manufacturer's "use by" date if the manufacturer determined the "use by" date based on food safety.^Pf

C. A refrigerated, ready-to-eat, time/temperature control for safety food ingredient or a portion of a refrigerated, ready-to-eat, time/temperature control for safety food that is subsequently combined with additional ingredients or portions of food shall retain the date marking of the earliest-prepared or first-prepared ingredient.^Pf

D. A date marking system that meets the criteria specified in subsections A and B of this section may include:

1. Using a method approved by the department for refrigerated, ready-to-eat time/temperature control for safety food that is frequently rewrapped, such as lunchmeat or a roast, or for which date marking is impractical, such as soft-serve mix or milk in a dispensing machine;

2. Marking the date or day of preparation, with a procedure to discard the food on or before the last date or day by which the food must be consumed on the premises, sold, or discarded as specified in subsection A of this section;

3. Marking the date or day the original container is opened in a food establishment, with a procedure to discard the food on or before the last date or day by which the food must be consumed on the premises, sold, or discarded as specified under subsection B of this section; or

4. Using calendar dates, days of the week, color-coded marks, or other effective marking methods, provided that the marking system shall be disclosed to the department upon request.

E. Subsections A and B of this section shall not apply to individual meal portions served or repackaged for sale from a bulk container upon a consumer's request or to shellstock.

F. Subsection B of this section shall not apply to the following foods prepared and packaged by a food processing plant inspected by a regulatory authority:

1. Deli salads, such as ham salad, seafood salad, chicken salad, egg salad, pasta salad, potato salad, and macaroni salad, manufactured in accordance with 21 CFR Part 117;

2. Hard cheeses containing not more than 39% moisture as defined in 21 CFR Part 133, such as cheddar, gruyere, parmesan and reggiano, and romano;

3. Semi-soft cheese containing more than 39% moisture, but not more than 50% moisture, as defined in 21 CFR Part 133, such as blue, edam, gorgonzola, gouda, and monterey jack;

4. Cultured dairy products as defined in 21 CFR Part 131, such as yogurt, sour cream, and buttermilk;

5. Preserved fish products, such as pickled herring and dried or salted cod, and other acidified fish products as defined in 21 CFR Part 114;

6. Shelf stable, dry fermented sausages, such as pepperoni and Genoa salami; and

7. Shelf stable salt-cured products such as prosciutto and Parma (ham).

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021; Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-840 Ready-to-eat, time/temperature control for safety food; disposition

A. A food specified under 12VAC5-421-830 A or B shall be discarded if it:

1. Exceeds either of the temperature and time combination specified in 12VAC5-421-830 A, except time that the product is frozen;^P

2. Is in a container or package that does not bear a date or day;^P or

3. Is inappropriately marked with a date or day that exceeds a temperature and time combination as specified in 12VAC5-421-830 A.^P

B. Refrigerated, ready-to-eat, time/temperature control for safety food prepared in a food establishment and dispensed through a vending machine with an automatic shutoff control shall be discarded if it exceeds a temperature and time combination as specified in 12VAC5-421-830 A.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-850 Time as a public health control

A. Except as specified under subsection D of this section, if time without temperature control is used as the public health control for a working supply of time/temperature control for safety food before cooking or for ready-to-eat time/temperature control for safety food that is displayed or held for sale or service, written procedures shall be prepared in advance, maintained in the food establishment, and made available to the department upon request that specify:^Pf

1. Methods of compliance with subsection B or C of this section;^Pf and

2. Methods of compliance with 12VAC5-421-800 for food that is prepared, cooked, and refrigerated before time is used as a public health control.^Pf

B. If time without temperature control is used as the public health control up to a maximum of four hours:

1. Unless otherwise specified in subdivision 2 of this subsection, the food shall have an initial temperature of 41°F (5°C) or less when removed from cold holding temperature control or 135°F (57°C) or greater when removed from hot holding temperature control; ^P

2. The food may have an initial temperature of 70°F (21°C) or less if:

a. The food is a ready-to-eat fruit or vegetable that upon cutting is rendered a time/temperature control for safety food; or

b. The food is a ready-to-eat, hermetically sealed food that upon opening is rendered a time/temperature control for safety food;

c. The food temperature does not exceed 70°F (21°C) within a maximum time period of four hours from the time the food was rendered a time/temperature control for safety food; and

d. The food is marked or otherwise identified to indicate the time that is four hours after the food is rendered a time/temperature control for safety food as specified in subdivisions a and b of this subdivision 2.

3. The food shall be marked or otherwise identified to indicate the time that is four hours after the food is removed from temperature control;^Pf

4. The food shall be cooked and served, served at any temperature if ready-to-eat, or discarded, within four hours from when the food is removed from temperature control;^P and

5. Food in unmarked containers or packages or marked to exceed a four-hour limit shall be discarded.^P

C. If time without temperature control is used as the public health control up to a maximum of six hours:

1. The food shall have an initial temperature of 41ºF (5ºC) or less when removed from temperature control and the food temperature may not exceed 70ºF (21ºC) within the six-hour period;^P

2. The food shall be monitored or an ambient air temperature shall be maintained to ensure that the warmest portion of the food does not exceed 70ºF (21ºC) during the six-hour period;^Pf

3. The food shall be marked or otherwise identified to indicate:^Pf

a. The time when the food is removed from 41ºF (5ºC) or less cold-holding temperature control,^Pf and

b. The time that is six hours after the food is removed from 41ºF (5ºC) or less cold-holding temperature control;^Pf

4. The food shall be:

a. Discarded if the temperature of the food exceeds 70ºF (21ºC);^Por

b. Cooked and served, served at any temperature if ready-to-eat, or discarded within a maximum of six hours from the point in time when the food is removed from 41ºF (5ºC) or less cold-holding temperature control;^P and

5. The food in unmarked containers or packages, or marked with a time that exceeds the six-hour limit shall be discarded.^P

D. A food establishment that serves a highly susceptible population may not use time as specified under subsection A, B, or C of this section as the public health control for raw eggs.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021; Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-860 Variance requirement

A food establishment shall obtain a variance from the department as specified in 12VAC5-421-3570 and 12VAC5-421-3580 before:^Pf

1. Smoking food as a method of food preservation rather than as a method of flavor enhancement;^Pf

2. Curing food;^Pf

3. Using food additives or adding components such as vinegar:^Pf

a. As a method of food preservation rather than as a method of flavor enhancement;^Pf or

b. To render a food so that it is not a time/temperature control for safety food; ^Pf

4. Packaging time/temperature control for safety food using a reduced oxygen packaging method except where the growth of and toxin formation by Clostridium botulinum and the growth of Listeria monocytogenes are controlled as specified under 12VAC5-421-870;^Pf

5. Operating a molluscan shellfish life-support system display tank used to store or display shellfish that are offered for human consumption;^Pf

6. Custom processing animals that are for personal use as food and not for sale or service in a food establishment;^Pf

7. Sprouting seeds or beans;^Pf or

8. Preparing food by another method that is determined by the department to require a variance.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-870 Reduced oxygen packaging without a variance, criteria

A. Except for a food establishment that obtains a variance pursuant to 12VAC5-421-860, a food establishment that packages time/temperature control for safety food using a reduced oxygen packaging method shall control the growth and toxin formation of Clostridium botulinum and the growth of Listeria monocytogenes.^P

B. Except as specified under subsection F of this section, a food establishment that packages time/temperature control for safety food using a reduced oxygen method shall implement a HACCP plan that contains the information specified under subdivisions 3 and 5 of 12VAC5-421-3630 and that:^Pf

1. Identifies the food to be packaged;^Pf

2. Except as specified in subsections C, D, and E of this section, requires that the packaged food be maintained at 41°F (5°C) or less and meet at least one of the following criteria:^Pf

a. Has an A_w of 0.91 or less;^Pf

b. Has a pH of 4.6 or less;^Pf

c. Is a meat or poultry product cured at a food processing plant regulated by the USDA using substances specified in 9 CFR 424.21 and is received in an intact package;^Pfor

d. Is a food with a high level of competing organisms such as raw meat, raw poultry, or raw vegetables; ^Pf

3. Describes how the package shall be prominently and conspicuously labeled on the principal display panel in bold type on a contrasting background, with instructions to:^Pf

a. Maintain the food at 41°F (5°C) or less;^Pf and

b. Discard the food if within 30 calendar days of its packaging it is not served for on-premises consumption, or consumed if served or sold for off-premises consumption;^Pf

4. Limits the refrigerated shelf life to (i) no more than 30 calendar days from packaging to consumption, except the time the product is maintained frozen, or (ii) the original manufacturer's "sell by" or "use by" date, whichever occurs first;^P

5. Includes operational procedures that:

a. Prohibit contacting ready-to-eat food with bare hands as specified in 12VAC5-421-450 B;^Pf

b. Identify a designated work area and the method by which:^Pf

(1) Physical barriers or methods of separation of raw foods and ready-to-eat foods minimize cross contamination;^Pf and

(2) Access to the processing equipment is limited to responsible trained personnel familiar with the potential hazards of the operation;^Pf and

c. Delineate cleaning and sanitization procedures for food contact surfaces;^Pf

6. Describes the training program that ensures that the individual responsible for the reduced oxygen packaging operation understands the:^Pf

a. Concepts required for safe operation;^Pf

b. Equipment and facilities;^Pf and

c. Procedures specified under subdivision B 5 of this section and subdivisions 3 and 5 of 12VAC5-421-3630;^Pf and

7. Is provided to the department before implementation pursuant to 12VAC5-421-3620 B.

C. Except for fish that is frozen before, during, and after packaging and bears a label indicating that it is to be kept frozen until time of use, a food establishment may not package fish using a reduced oxygen packaging method.^P

D. Except as specified in subsections C and F of this section, a food establishment that packages time/temperature control for safety food using a cook-chill or sous-vide process shall:

1. Submit to the department before implementation a HACCP plan that contains the information required pursuant to subdivisions 3 and 5 of 12VAC5-421-3630;^Pf

2. Ensure the food is:

a. Prepared and consumed on the premises, or prepared and consumed off the premises but within the same business entity with no distribution or sale of the bagged product to another business entity or the consumer;^Pf

b. Cooked to heat all parts of the food to a temperature and for a time pursuant to 12VAC5-421-700 A, B, and C;^P

c. Protected from contamination before and after cooking pursuant to 12VAC5-421-450 through 12VAC5-421-765;^P

d. Placed in a package with an oxygen barrier and sealed before cooking, or placed in a package and sealed immediately after cooking, and before reaching a temperature below 135°F (57°C);^P

e. Cooled to 41°F (5°C) in the sealed package pursuant to 12VAC5-421-800; and:^P

(1) Cooled to 34°F (1°C) within 48 hours of reaching 41°F (5°C) and held at that temperature until consumed or discarded within 30 days after the date of packaging;^P

(2) Held at 41°F (5°C) or less for no more than seven days, at which time the food must be consumed or discarded;^P

(3) Cooled to 34°F (1°C) within 48 hours of reaching 41°F (5°C), removed from refrigeration equipment that maintains 34°F (1°C) food temperature and then held at 41°F (5°C) or less for no more than seven days not to exceed 30 days from its date of packaging, at which time the food must be consumed or discarded;^P or

(4) Held frozen with no shelf-life restriction while frozen until consumed or used;^P

f. Held in a refrigeration unit that is equipped with an electronic system that continuously monitors time and temperature and is visually examined for proper operation twice daily;^Pf

g. If transported off site to a satellite location of the same business entity, equipped with verifiable electronic monitoring devices to ensure that times and temperatures are monitored during transportation;^Pf and

h. Labeled with the product name and the date packaged;^Pf

3. Maintain the records required to confirm that cooling and cold holding refrigeration time/temperature parameters are required as part of the HACCP plan, maintained, made available to the department upon request,^Pf and held for six months;^Pf and

4. Implement written operational procedures as specified under subdivision B 5 of this section and a training program as specified under subdivision B 6 of this section.^Pf

E. Except as specified under subsection F of this section, a food establishment that packages cheese using a reduced oxygen packaging method shall:

1. Limit the cheeses packaged to those that (i) are commercially manufactured in a food processing plant with no ingredients added in the food establishment and (ii) meet the Standards of Identity as specified in 21 CFR 133.150, 21 CFR 133.169, or 21 CFR 133.187;^P

2. Have a HACCP plan that contains the information specified in subdivisions 3 and 4 of 12VAC5-421-3630 and as specified under subdivisions B 1, B 3 a, B 5, and B 6 of this section;^Pf

3. Label the package on the principal display panel with a "use by" date that does not exceed 30 days from its packaging or the original manufacturer's "sell by" or "use by" date, whichever occurs first;^Pf and

4. Discard the reduced oxygen packaged cheese if it is not sold for off-premises consumption or consumed within 30 calendar days of its packaging.^Pf

F. A HACCP plan shall not be required if a food establishment uses a reduced oxygen packaging method to package time/temperature control for safety food that is always:

1. Labeled with the production time and date;

2. Held at 41°F (5°C) or less during refrigerated storage; and

3. Removed from its packaging in the food establishment within 48 hours after packaging.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021; Volume 42, Issue 25, eff. September 10, 2026.

Article 6 Food Identity, Presentation, and On-Premises Labeling

12VAC5-421-880 Standards of identity

Article 6 Food Identity, Presentation, and On-Premises Labeling

Packaged food shall comply with standard of identity requirements in 21 CFR Parts 131‑169 and 9 CFR Part 319, and the general requirements in 21 CFR Part 130 and 9 CFR Part 319, Subpart A.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 2, eff. October 16, 2007; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-890 Honestly presented

A. Food shall be offered for human consumption in a way that does not mislead or misinform the consumer.

B. Food or color additives, colored overwraps, or lights shall not be used to misrepresent the true appearance, color, or quality of a food.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 2, eff. October 16, 2007.

12VAC5-421-900 Food labels

A. Food packaged in a food establishment shall be labeled in accordance with all applicable laws and regulations, including 21 CFR Part 101 and 9 CFR Part 317.

B. Label information shall include:

1. The common name of the food or, absent a common name, an adequately descriptive identity statement;

2. If made from two or more ingredients, a list of ingredients and sub-ingredients in descending order of predominance by weight, including a declaration of artificial colors, artificial flavors, and chemical preservatives, if contained in the food;

3. An accurate declaration of the net quantity of contents;

4. The name and place of business of the manufacturer, packer, or distributor;

5. The name of the food source for each major food allergen contained in the food unless the food source is already part of the common or usual name of the respective ingredient;^Pf

6. Except as exempted in the Federal Food, Drug, and Cosmetic Act § 403(Q)(3) through (5), nutrition labeling as specified in 21 CFR Part 101 and 9 CFR Part 317, Subpart B; and

7. For any salmonid fish containing canthaxanthin or astaxanthin as a color additive, the labeling of the bulk fish container, including a list of ingredients, displayed on the retail container or by other written means, such as a counter card, that discloses the use of canthaxanthin or astaxanthin.

C. Bulk food that is available for consumer self-dispensing shall be prominently labeled with the following information in plain view of the consumer:

1. The manufacturer's or processor's label that was provided with the food; or

2. A card, sign, or other method of notification that includes the information specified under subdivisions B 1, B 2, B 5, and B 6 of this section.

D. Bulk, unpackaged foods such as bakery products and unpackaged foods that are portioned to consumer specification shall not need to be labeled if:

1. A health, nutrient content, or other claim is not made;

2. There are no state or local laws requiring labeling; and

3. The food is manufactured or prepared on the premises of the food establishment or at another food establishment or a food processing plant that is owned by the same person and is regulated by the food regulatory agency that has jurisdiction.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 2, eff. October 16, 2007; amended, Virginia Register Volume 26, Issue 6, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021; Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-910 Other forms of information

A. If required by law, consumer warnings shall be provided.

B. No person may conceal or alter a food establishment's or manufacturer's dating information on foods.

C. The permit holder shall notify consumers by written notification of the presence of major food allergens as an ingredient in unpackaged food items that are served or sold to the consumer.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 2, eff. October 16, 2007; amended, Virginia Register Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-920 [Reserved]. (Reserved)

12VAC5-421-930 Consumer advisory: consumption of animal foods that are raw, undercooked, or not otherwise processed to eliminate pathogens

A. Except as specified in 12VAC5-421-700 C and D 4 and under subdivision 3 of 12VAC5-421-950, if an animal food such as beef, eggs, fish, lamb, pork, poultry, or shellfish is served or sold raw, undercooked, or without otherwise being processed to eliminate pathogens, either in ready-to-eat form or as an ingredient in another ready-to-eat food, the permit holder shall inform consumers of the significantly increased risk of consuming such foods by way of a disclosure and reminder, as specified in subsections B and C of this section, using brochures, deli case or menu advisories, label statements, table tents, placards, or other effective written means.^Pf

B. Disclosure shall include:

1. A description of the animal-derived foods, such as "oysters on the half shell (raw oysters)," "raw-egg Caesar salad," and "hamburgers (can be cooked to order)";^Pf or

2. Identification of the animal-derived foods by asterisking them to a footnote that states that the items are served raw or undercooked, or contain (or may contain) raw or undercooked ingredients.^Pf

C. Reminder shall include asterisking the animal-derived foods requiring disclosure to a footnote that states:

1. "Regarding the safety of these items, written information is available upon request";^Pf

2. "Consuming raw or undercooked meats, poultry, seafood, shellfish, or eggs may increase your risk of foodborne illness";^Pf or

3. "Consuming raw or undercooked meats, poultry, seafood, shellfish, or eggs may increase your risk of foodborne illness, especially if you have certain medical conditions."^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 2, eff. October 16, 2007; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

Article 7 Contaminated Food

12VAC5-421-940 Discarding or reconditioning unsafe, adulterated, or contaminated food

A. A food that is unsafe, adulterated, or not honestly presented as specified in 12VAC5-421-260 shall be discarded or reconditioned according to an approved procedure.^P

B. Food that is not from an approved source as specified under 12VAC5-421-270 through 12VAC5-421-330 shall be discarded.^P

C. Ready-to-eat food that may have been contaminated by an employee who has been restricted or excluded as specified under 12VAC5-421-90 shall be rendered unusable and discarded.^P

D. Food that is contaminated by food employees, consumers, or other persons through contact with their hands, bodily discharges, such as nasal or oral discharges, or other means shall be discarded.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

Article 8 Special Requirements for Highly Susceptible Populations

12VAC5-421-950 Pasteurized foods, prohibited reservice, and prohibited food

In a food establishment that serves a highly susceptible population:

1. The following criteria apply to juice:

a. For the purposes of this subdivision only, children who are nine years of age or younger and receive food in a school, day care setting, or similar facility that provides custodial care are included as highly susceptible populations;

b. Prepackaged juice or a prepackaged beverage containing juice that bears a warning label as specified in 21 CFR 101.17(g) or a packaged juice or beverage containing juice that bears a warning label pursuant to subdivision 2 of 12VAC5-421-765 may not be served or offered for sale;^P and

c. Unpackaged juice that is prepared on the premises for service or sale in a ready-to-eat form shall be processed under a HACCP plan that contains the information pursuant to subdivisions 3, 5, and 6 of 12VAC5-421-3630 and pursuant to 21 CFR 120.24.^P

2. Pasteurized eggs or egg products shall be substituted for raw eggs in the preparation of:^P

a. Foods such as Caesar salad, hollandaise or bèarnaise sauce, mayonnaise, meringue, eggnog, ice cream, and egg-fortified beverages;^P and

b. Except as specified in subdivision 6 of this section, recipes in which more than one egg is broken and the eggs are combined.^P

3. The following foods shall not be served or offered for sale in a ready-to-eat form:^P

a. Raw animal foods such as raw fish, raw-marinated fish, raw molluscan shellfish, and steak tartare;^P

b. A partially cooked animal food such as lightly cooked fish, rare meat, soft-cooked eggs that are made from raw eggs, and meringue;^P

c. Raw seed sprouts;^P and

d. Packaged food as specified in 12VAC5-421-726.

4. A food employee may not contact ready-to-eat food pursuant to 12VAC5-421-450 B and E.^P

5. Time only, as the public health control as specified under 12VAC5-421-850 D, may not be used for raw eggs.^P

6. Subdivision 2 b of this section shall not apply if:

a. The raw eggs are combined immediately before cooking for one consumer's serving at a single meal, cooked as specified under 12VAC5-421-700 A 1, and served immediately, such as an omelet, soufflé, or scrambled eggs;

b. The raw eggs are combined as an ingredient immediately before baking and the eggs are thoroughly cooked to a ready-to-eat form, such as a cake, muffin, or bread; or

c. The preparation of the food is conducted under a HACCP plan that:

(1) Identifies the food to be prepared;

(2) Prohibits contacting ready-to-eat food with bare hands;

(3) Includes specifications and practices that ensure Salmonella Enteritidis growth is controlled before and after cooking and Salmonella Enteritidis is destroyed by cooking the eggs according to the temperature and time specified in 12VAC5-421-700 A 2;

(4) Contains the information required by subdivision 4 of 12VAC5-421-3630 including procedures that:

(a) Control cross contamination of ready-to-eat food with raw eggs; and

(b) Delineate cleaning and sanitization procedures for food-contact surfaces; and

(5) Describes the training program that ensures that the food employee responsible for the preparation of the food understands the procedures to be used.

7. Except as specified in subdivision 8 of this section, food may be re-served pursuant to 12VAC5-421-680 B 1 and B 2.

8. Food may not be re-served under the following conditions:

a. Food served to a patient or client under contact precautions in medical isolation or quarantine or protective environment isolation may not be re-served to others outside.

b. A package of food from a patient, client, or other consumer may not be re-served to a person in protective environment isolation.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021; Volume 42, Issue 25, eff. September 10, 2026.

Article 1 Materials for Construction and Repair

12VAC5-421-960 Multiuse, characteristics

Materials that are used in the construction of utensils and food-contact surfaces of equipment shall not allow the migration of deleterious substances or impart colors, odors, or tastes to food and under normal use conditions shall be:^P

1. Safe;^P

2. Durable, corrosion-resistant, and nonabsorbent;

3. Sufficient in weight and thickness to withstand repeated warewashing;

4. Finished to have a smooth, easily cleanable surface; and

5. Resistant to pitting, chipping, crazing, scratching, scoring, distortion, and decomposition.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-970 Cast iron, use limitation

A. Except as specified in subsections B and C of this section, cast iron shall not be used for utensils or food-contact surfaces of equipment.

B. Cast iron may be used as a surface for cooking.

C. Cast iron may be used in utensils for serving food if the utensils are used only as part of an uninterrupted process from cooking through service.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007.

12VAC5-421-980 Lead, use limitation

A. Ceramic, china, crystal utensils, and decorative utensils such as hand-painted ceramic or china that are used in contact with food shall be lead-free or contain levels of lead not exceeding the limits of the following utensil categories:^P

| Utensil Category | Ceramic Article Description | Maximum Lead mg/L | | --- | --- | --- | | Beverage Mugs, Cups, Pitchers | Coffee Mugs | 0.5 | | Large Hollowware (excluding pitchers) | Bowls > 1.1 Liter (1.16 Quart) | 1.0 | | Small Hollowware (excluding cups and mugs | Bowls <1.1 Liter (1.16 Quart) | 2.0 | | Flat tableware | Plates, Saucers | 3.0 |

B. Pewter alloys containing lead in excess of 0.05% may not be used as a food contact surface.^P

C. Solder and flux containing lead in excess of 0.2% may not be used as a food contact surface.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-990 Copper, use limitation

A. Except as specified in subsections B and C of this section, copper and copper alloys such as brass shall not be used in contact with a food that has a pH below 6 such as vinegar, fruit juice, or wine or for a fitting or tubing installed between a backflow prevention device and a carbonator.^P

B. Copper and copper alloys may be used in contact with beer brewing ingredients that have a pH below 6 in the prefermentation and fermentation steps of a beer brewing operation such as a brewpub or microbrewery.

C. Copper and copper alloys may be used in contact with apple butter and molasses that have a pH below 6 during the typical processing times (i.e., mixing, cooking, and cooling) for these products, as long as laboratory analysis does not reveal excessive levels of copper or other heavy metals in the finished product. Apple butter and molasses may not be held or stored in copper or copper alloys for time periods any longer than the typical processing times for these products.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-1000 Galvanized metal, use limitation

Galvanized metal shall not be used for utensils or food-contact surfaces of equipment that are used in contact with acidic food.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-1010 Sponges, use limitation

Sponges shall not be used in contact with cleaned and sanitized or in-use food-contact surfaces.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007.

12VAC5-421-1020 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; repealed, Volume 26, Issue 7, eff. January 1, 2010.

12VAC5-421-1030 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; repealed, Volume 26, Issue 7, eff. January 1, 2010.

12VAC5-421-1040 Wood, use limitation

A. Except as specified in subsections B, C, and D of this section, wood and wood wicker shall not be used as a food-contact surface.

B. Hard maple or an equivalently hard, close-grained wood may be used for:

1. Cutting boards; cutting blocks; bakers' tables; and utensils such as rolling pins, doughnut dowels, salad bowls, and chopsticks; and

2. Wooden paddles used in confectionery operations for pressure scraping kettles when manually preparing confections at a temperature of 230°F (110°C) or above.

C. Whole, uncut, raw fruits and vegetables, and nuts in the shell may be kept in the wood shipping containers in which they were received, until the fruits, vegetables, or nuts are used.

D. If the nature of the food requires removal of rinds, peels, husks, or shells before consumption, the whole, uncut, raw food may be kept in:

1. Untreated wood containers; or

2. Treated wood containers if the containers are treated with a preservative that meets the requirements specified in 21 CFR 178.3800.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007.

12VAC5-421-1050 Nonstick coatings, use limitation

Multiuse kitchenware such as frying pans, griddles, sauce pans, cookie sheets, and waffle bakers that have a perfluorocarbon resin coating shall be used with nonscoring or nonscratching utensils and cleaning aids.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1060 Nonfood-contact surfaces

Nonfood-contact surfaces of equipment that are exposed to splash, spillage, or other food soiling or that require frequent cleaning shall be constructed of a corrosion-resistant, nonabsorbent, and smooth material.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1070 Single-service and single-use, characteristics

A. Materials that are used to make single-service and single-use articles shall not:

1. Allow the migration of deleterious substances;^P or

2. Impart colors, odors, or tastes to food.

B. Materials that are used to make single-service and single-use articles shall be:

1. Safe,^Pand

2. Clean.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

Article 2 Design and Construction

12VAC5-421-1080 Equipment and utensils

Equipment and utensils shall be designed and constructed to be durable and to retain their characteristic qualities under normal use conditions.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1090 Food temperature measuring devices

Food temperature measuring devices shall not have sensors or stems constructed of glass, except that thermometers with glass sensors or stems that are encased in a shatterproof coating such as candy thermometers may be used.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-1100 Food-contact surfaces; cleanability

A. Multiuse food-contact surfaces shall be:

1. Smooth;^Pf

2. Free of breaks, open seams, cracks, chips, inclusions, pits, and similar imperfections;^Pf

3. Free of sharp internal angles, corners, and crevices;^Pf

4. Finished to have smooth welds and joints;^Pf and

5. Except as specified in subsection B of this section, accessible for cleaning and inspection by one of the following methods:

a. Without being disassembled;^Pf

b. By disassembling without the use of tools;^Pf or

c. By easy disassembling with the use of handheld tools commonly available to maintenance and cleaning personnel such as screwdrivers, pliers, open-end wrenches, and Allen wrenches.^Pf

B. Subdivision A 5 of this section does not apply to cooking oil storage tanks, distribution lines for cooking oils, or beverage syrup lines or tubes.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-1110 CIP equipment

A. CIP equipment shall meet the characteristics specified under 12VAC5-421-1100 and shall be designed and constructed so that:

1. Cleaning and sanitizing solutions circulate throughout a fixed system and contact all interior food-contact surfaces,^Pf and

2. The system is self-draining or capable of being completely drained of cleaning and sanitizing solutions.

B. CIP equipment that is not designed to be disassembled for cleaning shall be designed with inspection access points to ensure that all interior food-contact surfaces throughout the fixed system are being effectively cleaned.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-1120 "V" threads; use limitation

"V" type threads shall not be used on food-contact surfaces. This section does not apply to hot oil cooking or filtering equipment.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007.

12VAC5-421-1130 Hot oil filtering equipment

Hot oil filtering equipment shall meet the characteristics specified under 12VAC5-421-1100 or 12VAC5-421-1110 and shall be readily accessible for filter replacement and cleaning of the filter.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1140 Can openers

Cutting or piercing parts of can openers shall be readily removable for cleaning and for replacement.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1150 Nonfood-contact surfaces

Nonfood-contact surfaces shall be free of unnecessary ledges, projections, and crevices, and designed and constructed to allow easy cleaning and to facilitate maintenance.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1160 Kick plates; removable

Kick plates shall be designed so that the areas behind them are accessible for inspection and cleaning by being:

1. Removable by one of the methods specified under subdivision 5 of 12VAC5-421-1100 or capable of being rotated open; and

2. Removable or capable of being rotated open without unlocking equipment doors.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1170 Ventilation hood systems; filters

Filters or other grease extracting equipment shall be designed to be readily removable for cleaning and replacement if not designed to be cleaned in place.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1180 Temperature measuring devices; food

A. Food temperature measuring devices that are scaled only in Celsius or dually scaled in Celsius and Fahrenheit shall be accurate to plus or minus 1°C in the intended range of use.^Pf

B. Food temperature measuring devices that are scaled only in Fahrenheit shall be accurate to plus or minus 2°F in the intended range of use.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-1190 Temperature measuring devices; ambient air and water

A. Ambient air and water temperature measuring devices that are scaled in Celsius or dually scaled in Celsius and Fahrenheit shall be designed to be easily readable and accurate to plus or minus 1.5°C in the intended range of use.^Pf

B. Ambient air and water temperature measuring devices that are scaled only in Fahrenheit shall be accurate to plus or minus 3°F in the intended range of use.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-1200 Pressure measuring devices, mechanical warewashing equipment

Pressure measuring devices that display the pressures in the water supply line for the fresh hot water sanitizing rinse shall have increments of 1 pounds per square inch (7 kilopascals) or smaller and shall be accurate to ±2 pounds per square inch (±14 kilopascals) in the range indicated on the manufacturer's data plate.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010.

12VAC5-421-1210 Ventilation hood systems, drip prevention

Exhaust ventilation hood systems in food preparation and warewashing areas including components such as hoods, fans, guards, and ducting shall be designed to prevent grease or condensation from draining or dripping onto food, equipment, utensils, linens, and single-service and single-use articles.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1220 Equipment openings, closures and deflectors

A. A cover or lid for equipment shall overlap the opening and be sloped to drain.

B. An opening located within the top of a unit of equipment that is designed for use with a cover or lid shall be flanged upward at least two-tenths of an inch (5 millimeters).

C. Except as specified under subsection D of this section, fixed piping, temperature measuring devices, rotary shafts, and other parts extending into equipment shall be provided with a watertight joint at the point where the item enters the equipment.

D. If a watertight joint is not provided:

1. The piping, temperature measuring devices, rotary shafts, and other parts extending through the openings shall be equipped with an apron designed to deflect condensation, drips, and dust from openings into the food; and

2. The opening shall be flanged as specified under subsection B of this section.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1230 Dispensing equipment, protection of equipment and food

In equipment that dispenses or vends liquid food or ice in unpackaged form:

1. The delivery tube, chute, orifice, and splash surfaces directly above the container receiving the food shall be designed in a manner, such as with barriers, baffles, or drip aprons, so that drips from condensation and splash are diverted from the opening of the container receiving the food;

2. The delivery tube, chute, and orifice shall be protected from manual contact such as by being recessed;

3. The delivery tube or chute and orifice of equipment used to vend liquid food or ice in unpackaged form to self-service consumers shall be designed so that the delivery tube or chute and orifice are protected from dust, insects, rodents, and other contamination by a self-closing door if the equipment is:

a. Located in an outside area that does not otherwise afford the protection of an enclosure against the rain, windblown debris, insects, rodents, and other contaminants that are present in the environment, or

b. Available for self-service during hours when it is not under the full-time supervision of a food employee; and

4. The dispensing equipment actuating lever or mechanism and filling device of consumer self-service beverage dispensing equipment shall be designed to prevent contact with the lip-contact surface of glasses or cups that are refilled.

5. Dispensing equipment in which time/temperature control for safety food in homogenous liquid form is maintained outside of the temperature control requirements as specified in 12VAC5-421-820 C shall:

a. Be specifically designed and equipped to maintain the commercial sterility of aseptically packaged food in a homogenous liquid form for a specified duration from the time of opening the packaging within the equipment;^P and

b. Conform to the requirements for this equipment as specified in NSF/ANSI 18-2006 Manual Food and Beverage Dispensing Equipment, 2012, (NSF International).^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-1240 Vending machine, vending stage closure

The dispensing compartment of a vending machine including a machine that is designed to vend prepackaged snack food that is not time/temperature control for safety food such as chips, party mixes, and pretzels shall be equipped with a self-closing door or cover if the machine is:

1. Located in an outside area that does not otherwise afford the protection of an enclosure against the rain, windblown debris, insects, rodents, and other contaminants that are present in the environment; or

2. Available for self-service during hours when it is not under the full-time supervision of a food employee.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-1250 Bearings and gear boxes, leakproof

Equipment containing bearings and gears that require lubricants shall be designed and constructed so that the lubricant can not leak, drip, or be forced into food or onto food-contact surfaces.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1260 Beverage tubing, separation

Except for cold plates that are constructed integrally with an ice storage bin, beverage tubing and cold-plate beverage cooling devices may not be installed in contact with stored ice.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010.

12VAC5-421-1270 Ice units, separation of drains

Liquid waste drain lines shall not pass through an ice machine or ice storage bin.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007.

12VAC5-421-1280 Condenser unit, separation

If a condenser unit is an integral component of equipment, the condenser unit shall be separated from the food and food storage space by a dustproof barrier.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1290 Can openers on vending machines

Cutting or piercing parts of can openers on vending machines shall be protected from manual contact, dust, insects, rodents, and other contamination.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1300 Molluscan shellfish tanks

A. Except as specified under subsection B of this section, molluscan shellfish life support system display tanks shall not be used to store or display shellfish that are offered for human consumption and shall be conspicuously marked so that it is obvious to consumers that the shellfish are for display only.^P

B. Molluscan shellfish life-support system display tanks that are used to store or display shellfish that are offered for human consumption shall be operated and maintained in accordance with a variance granted by the department as specified in 12VAC5-421-3570 and a HACCP plan that:^Pf

1. Is submitted by the permit holder and approved as specified under 12VAC5-421-3620;^Pfand

2. Ensures that:

a. Water used with fish other than molluscan shellfish does not flow into the molluscan tank;^Pf

b. The safety and quality of the shellfish as they were received are not compromised by the use of the tank;^Pf and

c. The identity of the source of the shellstock is retained as specified under 12VAC5-421-440.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-1310 Vending machines, automatic shutoff

A. A machine vending time/temperature control for safety food shall have an automatic control that prevents the machine from vending food:

1. If there is a power failure, mechanical failure, or other condition that results in an internal machine temperature that cannot maintain food temperatures as specified under Part III (12VAC5-421-260 et seq.) of this chapter;^P and

2. If a condition specified under subdivision 1 of this subsection occurs, until the machine is serviced and restocked with food that has been maintained at temperatures specified under Part III.^P

B. When the automatic shutoff within a machine vending time/temperature control for safety food is activated:

1. In a refrigerated vending machine, the ambient temperature shall not exceed 41°F (5°C) for more than 30 minutes immediately after the machine is filled, serviced, or restocked;^P or

2. In a hot holding vending machine, the ambient temperature shall not be less than 135°F (57°C) for more than 120 minutes immediately after the machine is filled, serviced, or restocked.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-1320 Temperature measuring devices

A. In a mechanically refrigerated or hot food storage unit, the sensor of a temperature measuring device shall be located to measure the air temperature or a simulated product temperature in the warmest part of a mechanically refrigerated unit and in the coolest part of a hot food storage unit.

B. Except as specified in subsection C of this section, cold or hot holding equipment used for time/temperature control for safety food shall be designed to include and shall be equipped with at least one integral or affixed temperature measuring device that is located to allow easy viewing of the device's temperature display.

C. Subsection B of this section does not apply to equipment for which the placement of a temperature measuring device is not a practical means for measuring the ambient air surrounding the food because of the design, type, and use of the equipment, such as calrod units, heat lamps, cold plates, bain-maries, steam tables, insulated food transport containers, and salad bars.

D. Temperature measuring devices shall be designed to be easily readable.

E. Food temperature measuring devices and water temperature measuring devices on warewashing machines shall have a numerical scale, printed record, or digital readout in increments no greater than 2°F or 1°C in the intended range of use.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-1330 Warewashing machine, data plate operating specifications

A warewashing machine shall be provided with an easily accessible and readable data plate affixed to the machine by the manufacturer that indicates the machine's design and operating specifications including the:

1. Temperatures required for washing, rinsing, and sanitizing;

2. Pressure required for the fresh water sanitizing rinse unless the machine is designed to use only a pumped sanitizing rinse; and

3. Conveyor speed for conveyor machines or cycle time for stationary rack machines.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007.

12VAC5-421-1340 Warewashing machines, internal baffles

Warewashing machine wash and rinse tanks shall be equipped with baffles, curtains, or other means to minimize internal cross contamination of the solutions in wash and rinse tanks.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007.

12VAC5-421-1350 Warewashing machines, temperature measuring devices

A warewashing machine shall be equipped with a temperature measuring device that indicates the temperature of the water:

1. In each wash and rinse tank;^Pf and

2. As the water enters the hot water sanitizing final rinse manifold or in the chemical sanitizing solution tank.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-1360 Manual warewashing equipment, heaters and baskets

If hot water is used for sanitization in manual warewashing operations, the sanitizing compartment of the sink shall be:

1. Designed with an integral heating device that is capable of maintaining water at a temperature not less than 171°F (77°C);^Pf and

2. Provided with a rack or basket to allow complete immersion of equipment and utensils into the hot water.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-1370 Warewashing machines, sanitizer level indicator automatic dispensing of detergents and sanitizers

A. A warewashing machine installed after March 1, 2002, shall be equipped to:

1. Automatically dispense detergents and sanitizers;^Pf and

2. Incorporate a visual means to verify that detergents and sanitizers are delivered or a visual or audible alarm to signal if the detergents and sanitizers are not delivered to the respective washing and sanitizing cycles.^Pf

B. Existing warewashing equipment shall be upgraded or replaced to meet the requirements of subsection A of this section.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-1380 Warewashing machines, flow pressure device

A. Warewashing machines that provide a fresh hot water sanitizing rinse shall be equipped with a pressure gauge or similar device such as a transducer that measures and displays the water pressure in the supply line immediately before entering the warewashing machine; and

B. If the flow pressure measuring device is upstream of the fresh hot water sanitizing rinse control valve, the device shall be mounted in a one-fourth inch or 6.4 millimeter Iron Pipe Size (IPS) valve.

C. Subsections A and B of this section do not apply to a machine that uses only a pumped or recirculated sanitizing rinse.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 35, Issue 1, eff. October 3, 2018; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-1390 Warewashing sinks and drainboards, self-draining

Sinks and drainboards of warewashing sinks and machines shall be self-draining.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1400 Equipment compartments, drainage

Equipment compartments that are subject to accumulation of moisture due to conditions such as condensation, food or beverage drip, or water from melting ice shall be sloped to an outlet that allows complete draining.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1410 Vending machines, liquid waste products

A. Vending machines designed to store beverages that are packaged in containers made from paper products shall be equipped with diversion devices and retention pans or drains for container leakage.

B. Vending machines that dispense liquid food in bulk shall be:

1. Provided with an internally mounted waste receptacle for the collection of drip, spillage, overflow, or other internal wastes; and

2. Equipped with an automatic shutoff device that will place the machine out of operation before the waste receptacle overflows.

C. Shutoff devices specified under subdivision B 2 of this section shall prevent water or liquid food from continuously running if there is a failure of a flow control device in the water or liquid food system or waste accumulation that could lead to overflow of the waste receptacle.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1420 Case lot handling apparatuses, movability

Apparatuses, such as dollies, pallets, racks, and skids used to store and transport large quantities of packaged foods received from a supplier in a cased or overwrapped lot, shall be designed to be moved by hand or by conveniently available equipment such as hand trucks and forklifts.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 26, Issue 7, eff. January 1, 2010.

12VAC5-421-1430 Vending machine doors and openings

A. Vending machine doors and access opening covers to food and container storage spaces shall be tight-fitting so that the space along the entire interface between the doors or covers and the cabinet of the machine, if the doors or covers are in a closed position, is no greater than one-sixteenth inch or 1.5 millimeters by:

1. Being covered with louvers, screens, or materials that provide an equivalent opening of not greater than one-sixteenth inch or 1.5 millimeters. Screening of 12 mesh to 1 inch (12 or more mesh to 2.5 centimeters) meets this requirement;

2. Being effectively gasketed;

3. Having interface surfaces that are at least one-half inch wide or 13 millimeters; or

4. Jambs or surfaces used to form an L-shaped entry path to the interface.

B. Vending machine service connection openings through an exterior wall of a machine shall be closed by sealants, clamps, or grommets so that the openings are no larger than 1.5 millimeters or one-sixteenth inch.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1435 Food equipment, certification and classification

Food equipment that is certified or classified for sanitation in conformance to a recognized American National Standards Institute (ANSI)-accredited certification program is deemed to comply with the requirements of Articles 1 (12VAC5-421-960 et seq.) and 2 (12VAC5-421-1080 et seq.) of this part.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 22, eff. July 12, 2016; amended, Virginia Register Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-1440 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; repealed, Virginia Register Volume 26, Issue 7, eff. January 1, 2010.

Article 3 Numbers and Capacities

12VAC5-421-1450 Cooling, heating, and holding capacities

Equipment for cooling and heating food, and holding cold and hot food, shall be sufficient in number and capacity to provide food temperatures as specified under Part III (12VAC5-421-260 et seq.) of this chapter.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-1460 Manual warewashing, sink compartment requirements

A. Except as specified in subsection C of this section, a sink with at least three compartments shall be provided for manually washing, rinsing, and sanitizing equipment and utensils.^Pf

B. Sink compartments shall be large enough to accommodate immersion of the largest equipment and utensils. If equipment or utensils are too large for the warewashing sink, a warewashing machine or alternative equipment as specified in subsection C of this section shall be used.^Pf

C. Alternative manual warewashing equipment may be used when there are special cleaning needs or constraints and its use is approved. Alternative manual warewashing equipment may include:

1. High-pressure detergent sprayers;

2. Low-pressure or line-pressure spray detergent foamers;

3. Other task-specific cleaning equipment;

4. Brushes or other implements;

5. Two-compartment sinks as specified under subsections D and E of this section; or

6. Receptacles that substitute for the compartments of a multicompartment sink.

D. Before a two-compartment sink is used:

1. The permit holder shall have its use approved; and

2. The permit holder shall limit the number of kitchenware items cleaned and sanitized in the two-compartment sink and shall limit warewashing to batch operations for cleaning kitchenware such as between cutting one type of raw meat and another or cleanup at the end of a shift, and shall:

a. (i) Make up the cleaning and sanitizing solutions immediately before use and drain them immediately after use, and (ii) use a detergent-sanitizer to sanitize and apply the detergent-sanitizer in accordance with the manufacturer's label instructions and as specified under 12VAC5-421-1710; or

b. A hot water sanitization immersion step shall be used as specified under subdivision 3 of 12VAC5-421-1860.

E. A two-compartment sink shall not be used for warewashing operations where cleaning and sanitizing solutions are used for a continuous or intermittent flow of kitchenware or tableware in an ongoing warewashing process.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-1470 Drainboards

Drainboards, utensil racks, or tables large enough to accommodate all soiled and cleaned items that may accumulate during hours of operation shall be provided for necessary utensil holding before cleaning and after sanitizing.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1480 Ventilation hood systems, adequacy

Ventilation hood systems and devices shall be sufficient in number and capacity to prevent grease or condensation from collecting on walls and ceilings.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1490 Clothes washers and dryers

A. Except as specified in subsection B of this section, if work clothes or linens are laundered on the premises, a mechanical clothes washer and dryer shall be provided and used.

B. If on-premises laundering is limited to wiping cloths intended to be used moist, or wiping cloths are air-dried as specified under 12VAC5-421-1970, a mechanical clothes washer and dryer need not be provided.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1500 Utensils, consumer self-service

A food dispensing utensil shall be available for each container displayed at a consumer self-service unit such as a buffet or salad bar.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-1510 Food temperature measuring devices

A. Food temperature measuring devices shall be provided and readily accessible for use in ensuring attainment and maintenance of food temperatures as specified under Part III (12VAC5-421-260 et seq.) of this chapter.^Pf

B. A temperature measuring device with a suitable small-diameter probe that is designed to measure the temperature of thin masses shall be provided and readily accessible to accurately measure the temperature in thin foods such as meat patties and fish fillets.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-1520 Temperature measuring devices, manual and mechanical warewashing

A. In manual warewashing operations, a temperature measuring device shall be provided and readily accessible for frequently measuring the washing and sanitizing temperatures.^Pf

B. In hot water mechanical warewashing operations, an irreversible registering temperature indicator shall be provided and readily accessible for measuring the utensil surface temperature.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-1530 Sanitizing solutions, testing devices

A test kit or other device that accurately measures the concentration in mg/L (ppm) of sanitizing solutions shall be provided and readily accessible for use.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-1535 Cleaning agents and sanitizers, availability

A. A cleaning agent that is used to clean equipment and utensils pursuant to Article 6 (12VAC5-421-1770 et seq.) of this part shall be provided and available for use during all hours of operation.^Pf

B. Except for a chemical sanitizer that is generated on site at the time of use, a chemical sanitizer that is used to sanitize equipment and utensils pursuant to Article 7 (12VAC5-421-1885 et seq.) of this part shall be provided and available for use during all hours of operation.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 22, eff. July 12, 2016; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021; Volume 42, Issue 25, eff. September 10, 2026.

Article 4 Location and Installation

12VAC5-421-1540 Equipment, clothes washers and dryers, and storage cabinets, contamination prevention

A. Equipment, cabinets used for the storage of food, or cabinets used to store cleaned and sanitized equipment, utensils, laundered linens, and single-service and single-use articles may not be located:

1. In locker rooms, except pursuant to subsection B of this section;

2. In toilet rooms or vestibules;^Pf

3. In garbage rooms;

4. In mechanical rooms;

5. Under sewer lines that are not shielded to intercept potential drips;

6. Under leaking water lines including leaking automatic fire sprinkler heads or under lines on which water has condensed;

7. Under open stairwells; or

8. Under other sources of contamination.

B. A storage cabinet used for linens or single-service or single-use articles may be stored in a locker room.

C. If a mechanical clothes washer or dryer is provided, it shall be located only where there is no exposed food; clean equipment, utensils, and linens; unwrapped single-service and single-use articles; and so that the washer or dryer is protected from contamination.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-1550 Fixed equipment, spacing or sealing

A. Equipment that is fixed because it is not easily movable shall be installed so that it is:

1. Spaced to allow access for cleaning along the sides, behind, and above the equipment;

2. Spaced from adjoining equipment, walls, and ceilings a distance of not more than 1/32 inch or 1 millimeter; or

3. Sealed to adjoining equipment or walls, if the equipment is exposed to spillage or seepage.

B. Counter-mounted equipment that is not easily movable shall be installed to allow cleaning of the equipment and areas underneath and around the equipment by being:

1. Sealed ; or

2. Elevated on legs as specified under 12VAC5-421-1560 D.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 26, Issue 7, eff. January 1, 2010; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-1560 Fixed equipment, elevation or sealing

A. Except as specified in subsections B and C of this section, floor-mounted equipment that is not easily movable shall be sealed to the floor or elevated on legs that provide at least a 6 inch (15 centimeter) clearance between the floor and the equipment.

B. If no part of the floor under the floor-mounted equipment is more than 6 inches (15 centimeters) from the point of cleaning access, the clearance space may be only 4 inches (10 centimeters).

C. This section does not apply to display shelving units, display refrigeration units, and display freezer units located in the consumer shopping areas of a retail food store, if the floor under the units is maintained clean.

D. Except as specified in subsection E of this section, counter-mounted equipment that is not easily movable shall be elevated on legs that provide at least a 4-inch (10 centimeter) clearance between the table and the equipment.

E. The clearance space between the table and counter-mounted equipment may be:

1. Three inches (7.5 centimeters) if the horizontal distance of the table top under the equipment is no more than 20 inches (50 centimeters) from the point of access for cleaning; or

2. Two inches (5 centimeters) if the horizontal distance of the table top under the equipment is no more than 3 inches (7.5 centimeters) from the point of access for cleaning.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 26, Issue 7, eff. January 1, 2010.

Article 5 Maintenance and Operation

12VAC5-421-1570 Good repair and proper adjustment

Article 5 Maintenance and Operation

A. Equipment shall be maintained in a state of repair and condition that meets the requirements specified under Articles 1 (12VAC5-421-960 et seq.) and 2 (12VAC5-421-1080 et seq.) of this part. Unused or non-functioning equipment shall be removed from the premises.

B. Equipment components such as doors, seals, hinges, fasteners, and kick plates shall be kept intact, tight, and adjusted in accordance with manufacturer's specifications.

C. Cutting or piercing parts of can openers shall be kept sharp to minimize the creation of metal fragments that can contaminate food when the container is opened.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1580 Cutting surfaces

Surfaces such as cutting blocks and boards that are subject to scratching and scoring shall be resurfaced if they can no longer be effectively cleaned and sanitized, or discarded if they are not capable of being resurfaced.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1590 Microwave ovens

Microwave ovens shall meet the safety standards specified in 21 CFR 1030.10.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1600 Warewashing equipment, cleaning frequency

A warewashing machine; the compartments of sinks, basins, or other receptacles used for washing and rinsing equipment, utensils, or raw foods, or laundering wiping cloths; and drainboards or other equipment used to substitute for drainboards as specified under 12VAC5-421-1470 shall be cleaned:

1. Before use;

2. Throughout the day at a frequency necessary to prevent recontamination of equipment and utensils and to ensure that the equipment performs its intended function; and

3. If used, at least every 24 hours.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1610 Warewashing machines, manufacturers' operating instructions

A. A warewashing machine and its auxiliary components shall be operated in accordance with the machine's data plate and other manufacturer's instructions.

B. A warewashing machine's conveyor speed or automatic cycle times shall be maintained accurately timed in accordance with manufacturer's specifications.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1620 Warewashing sinks, use limitation

A. A warewashing sink shall not be used for handwashing.

B. If a warewashing sink is used to wash wiping cloths, wash produce, or thaw food, the sink shall be cleaned as specified under 12VAC5-421-1600 before and after each time it is used to wash wiping cloths or wash produce or thaw food. Sinks used to wash or thaw food shall be sanitized as specified under Article 7 (12VAC5-421-1885 et seq.) of this part before and after using the sink to wash produce or thaw food.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-1630 Warewashing equipment, cleaning agents

When used for warewashing, the wash compartment of a sink, mechanical warewasher, or wash receptacle of alternative manual warewashing equipment as specified in 12VAC5-421-1460 C, shall contain a wash solution of soap, detergent, acid cleaner, alkaline cleaner, degreaser, abrasive cleaner, or other cleaning agent according to the cleaning agent manufacturer's label instructions.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-1640 Warewashing equipment, clean solutions

The wash, rinse, and sanitize solutions shall be maintained clean.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007.

12VAC5-421-1650 Manual warewashing equipment, wash solution temperature

The temperature of the wash solution in manual warewashing equipment shall be maintained at not less than 110°F (43°C) or the temperature specified on the cleaning agent manufacturer's label instructions.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-1660 Mechanical warewashing equipment, wash solution temperature

A. The temperature of the wash solution in spray type warewashers that use hot water to sanitize shall not be less than:

1. For a stationary rack, single temperature machine, 165°F (74°C);^Pf

2. For a stationary rack, dual temperature machine, 150°F (66°C);^Pf

3. For a single tank, conveyor, dual temperature machine, 160°F (71°C);^Pf or

4. For a multitank, conveyor, multitemperature machine, 150°F (66°C).^Pf

B. The temperature of the wash solution in spray-type warewashers that use chemicals to sanitize shall not be less than 120°F (49°C).^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-1670 Manual warewashing equipment, hot water sanitization temperatures

If immersion in hot water is used for sanitizing in a manual operation, the temperature of the water shall be maintained at 171°F (77°C) or above.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-1680 Mechanical warewashing equipment, hot water sanitization temperatures

A. Except as specified in subsection B of this section, in a mechanical operation, the temperature of the fresh hot water sanitizing rinse as it enters the manifold shall not be more than 194°F (90°C), or less than:^Pf

1. For a stationary rack, single temperature machine, 165°F (74°C);^Pfor

2. For all other machines, 180°F (82°C).^Pf

B. The maximum temperature specified under subsection A of this section does not apply to the high pressure and temperature systems with wand-type, hand-held, spraying devices used for the in-place cleaning and sanitizing of equipment such as meat saws.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-1690 Mechanical warewashing equipment, sanitization pressure

The flow pressure of the fresh hot water sanitizing rinse in a warewashing machine, as measured in the water line immediately downstream or upstream from the fresh hot water sanitizing rinse control valve, shall be within the range specified on the machine manufacturer's data plate and may not be less than five pounds per square inch (35 kilopascals) or more than 30 pounds per square inch (200 kilopascals).

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010.

12VAC5-421-1700 Manual and mechanical warewashing equipment, chemical sanitization - 2011 temperature, pH, concentration, and hardness

A chemical sanitizer used in a sanitizing solution for a manual or mechanical operation at contact times specified under subdivision 3 of 12VAC5-421-1900 shall meet the criteria as specified under 12VAC5-421-3380, shall be used in accordance with the EPA-registered label use instructions,^P and shall be used as follows:

1. A chlorine solution shall have a minimum temperature based on the concentration and pH of the solution as listed in the following chart:^P

| | Minimum Concentration | Minimum Temperature | | | --- | --- | --- | --- | | | mg/L (ppm) | pH 10 or less °F (°C) | pH 8 or less °F (°C) | | | 25-49 | 120 (49) | 120 (49) | | | 50-99 | 100 (38) | 75 (24) | | | 100 | 55 (13) | 55 (13) |

2. An iodine solution shall have a:

a. Minimum temperature of 68°F (20°C);^P

b. pH of 5.0 or less or a pH no higher than the level for which the manufacturer specifies the solution is effective;^P and

c. Concentration between 12.5 mg/L (ppm) and 25 mg/L (ppm);^P

3. A quaternary ammonium compound solution shall:

a. Have a minimum temperature of 75°F (24°C);^P

b. Have a concentration as specified under 12VAC5-421-3380 and as indicated by the manufacturer's use directions included in the labeling;^P and

c. Be used only in water with 500 mg/L hardness or less or in water having a hardness no greater than specified by the manufacturer's label;^P

4. If another solution of a chemical specified under subdivisions 1, 2 and 3 of this section is used, the permit holder shall demonstrate to the department that the solution achieves sanitization and the use of the solution shall be approved;^P

5. If a chemical sanitizer other than chlorine, iodine, or a quaternary ammonium compound is used, it shall be applied in accordance with the EPA-registered label use instructions;^Pand

6. If a chemical sanitizer is generated by a device located on site at the food establishment it shall be used as specified in subdivisions 1 through 4 of this section and shall be produced by a device that:

a. Complies with regulation as specified in §§ 2(q)(1) and 12 of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA),^P

b. Complies with 40 CFR 152.500 and 40 CFR 156.10,^P

c. Displays the EPA device manufacturing facility registration number on the device,^Pf and

d. Is operated and maintained in accordance with manufacturer's instructions.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-1710 Manual warewashing equipment, chemical sanitization using detergent-sanitizers

If a detergent-sanitizer is used to sanitize in a cleaning and sanitizing procedure where there is no distinct water rinse between the washing and sanitizing steps, the agent applied in the sanitizing step shall be the same detergent-sanitizer that is used in the washing step.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007.

12VAC5-421-1720 Warewashing equipment, determining chemical sanitizer concentration

Concentration of the sanitizing solution shall be accurately determined by using a test kit or other device.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-1730 Good repair and calibration

A. Utensils shall be maintained in a state of repair or condition that complies with the requirements specified under Articles 1 (12VAC5-421-960 et seq.) and 2 (12VAC5-421-1080 et seq.) of this part or shall be discarded.

B. Food temperature measuring devices shall be calibrated in accordance with manufacturer's specifications as necessary to ensure their accuracy.^Pf

C. Ambient air temperature, water pressure, and water temperature measuring devices shall be maintained in good repair and be accurate within the intended range of use.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-1740 Single-service and single-use articles, required use

A food establishment without facilities specified under Articles 6 (12VAC5-421-1770 et seq.) and 7 (12VAC5-421-1885 et seq.) of this part for cleaning and sanitizing kitchenware and tableware shall provide only single-use kitchenware, single-service articles, and single-use articles for use by food employees and single-service articles for use by consumers.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-1750 Single-service and single-use articles, use limitation

A. Single-service and single-use articles shall not be reused.

B. The bulk milk container dispensing tube shall be cut on the diagonal leaving no more than one inch protruding from the chilled dispensing head.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007.

12VAC5-421-1760 Shells, use limitation

Mollusk and crustacea shells shall not be used more than once as serving containers.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007.

Article 6 Cleaning of Equipment and Utensils

12VAC5-421-1770 Equipment, food-contact surfaces, non-food-contact surfaces, and utensils

A. Equipment food-contact surfaces and utensils shall be clean to sight and touch.^Pf

B. The food-contact surfaces of cooking equipment and pans shall be kept free of encrusted grease deposits and other soil accumulations.

C. Non-food-contact surfaces of equipment shall be kept free of an accumulation of dust, dirt, food residue, and other debris.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-1780 Equipment food-contact surfaces and utensils

A. Equipment food-contact surfaces and utensils shall be cleaned:

1. Except as specified in subsection B of this section, before each use with a different type of raw animal food such as beef, fish, lamb, pork, or poultry;^P

2. Each time there is a change from working with raw foods to working with ready-to-eat foods;^P

3. Between uses with raw fruits and vegetables and with time/temperature control for safety food;^P

4. Before using or storing a food temperature measuring device;^P and

5. At any time during the operation when contamination may have occurred.^P

B. Subdivision A 1 of this section does not apply if the food contact surface or utensil is in contact with a succession of different types of raw meat and poultry each requiring a higher cooking temperature as specified under 12VAC5-421-700 than the previous type.

C. Except as specified in subsection D of this section, if used with time/temperature control for safety food, equipment food-contact surfaces and utensils shall be cleaned throughout the day at least every four hours.^P

D. Surfaces of utensils and equipment contacting time/temperature control for safety food may be cleaned less frequently than every four hours if:

1. In storage, containers of time/temperature control for safety food and their contents are maintained at temperatures specified under Part III (12VAC5-421-260 et seq.) of this chapter and the containers are cleaned when they are empty;

2. Utensils and equipment are used to prepare food in a refrigerated room or area that is maintained at one of the temperatures in the following chart and (i) the utensils and equipment are cleaned at the frequency in the following chart that corresponds to the temperature; and (ii) the cleaning frequency based on the ambient temperature of the refrigerated room or area is documented in the food establishment:

| | Temperature | Cleaning Frequency | | --- | --- | --- | | | 41°F (5.0°C) or less | 24 hours | | | >41°F - 45°F (>5.0°C - 7.2°C) | 20 hours | | | >45°F - 50°F (>7.2°C - 10.0°C) | 16 hours | | | >50°F - 55°F (>10.0°C - 12.8°C) | 10 hours |

3. Containers in serving situations such as salad bars, delis, and cafeteria lines hold ready-to-eat time/temperature control for safety food that is maintained at the temperatures specified under Part III, are intermittently combined with additional supplies of the same food that is at the required temperature, and the containers are cleaned at least every 24 hours;

4. Temperature measuring devices are maintained in contact with food, such as when left in a container of deli food or in a roast, held at temperatures specified under Part III;

5. Equipment is used for storage of packaged or unpackaged food such as a reach-in refrigerator and the equipment is cleaned at a frequency necessary to preclude accumulation of soil residues;

6. The cleaning schedule is approved based on consideration of:

a. Characteristics of the equipment and its use;

b. The type of food involved;

c. The amount of food residue accumulation; and

d. The temperature at which the food is maintained during the operation and the potential for the rapid and progressive multiplication of pathogenic or toxigenic microorganisms that are capable of causing foodborne disease; or

7. In-use utensils are intermittently stored in a container of water in which the water is maintained at 135°F (57°C) or more and the utensils and container are cleaned at least every 24 hours or at a frequency necessary to preclude accumulation of soil residues.

E. Except when dry cleaning methods are used as specified under 12VAC5-421-1810, surfaces of utensils and equipment contacting food that is not time/temperature control for safety food shall be cleaned:

1. At any time when contamination may have occurred;

2. At least every 24 hours for iced tea dispensers and consumer self-service utensils such as tongs, scoops, or ladles;

3. Before restocking consumer self-service equipment and utensils such as condiment dispensers and display containers;

4. At a frequency specified by the manufacturer or absent manufacturer specifications, at a frequency necessary to preclude accumulation of soil or mold. To include equipment such as ice bins and beverage dispensing nozzles and enclosed components of equipment such as ice makers, cooking oil storage tanks and distribution lines, beverage and syrup dispensing lines or tubes, coffee bean grinders, and water vending equipment.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-1790 Cooking and baking equipment

A. The food-contact surfaces of in-use cooking and baking equipment shall be cleaned at least every 24 hours. This section does not apply to hot oil cooking and filtering equipment if it is cleaned as specified in 12VAC5-421-1780 D 6.

B. The cavities and door seals of microwave ovens shall be cleaned at least every 24 hours by using the manufacturer's recommended cleaning procedure.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1800 Nonfood-contact surfaces

Nonfood-contact surfaces of equipment shall be cleaned at a frequency necessary to preclude accumulation of soil residues.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1810 Dry cleaning

A. If used, dry cleaning methods such as brushing, scraping, and vacuuming shall contact only surfaces that are soiled with dry food residues that are not time/temperature control for safety food.

B. Cleaning equipment used in dry cleaning food-contact surfaces shall not be used for any other purpose.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-1820 Precleaning

A. Food debris on equipment and utensils shall be scrapped over a waste disposal unit, or garbage receptacle or shall be removed in a warewashing machine with a prewash cycle.

B. If necessary for effective cleaning, utensils and equipment shall be preflushed, presoaked, or scrubbed with abrasives.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007.

12VAC5-421-1830 Loading of soiled items, warewashing machines

Soiled items to be cleaned in a warewashing machine shall be loaded into racks, trays, or baskets or onto conveyors in a position that:

1. Exposes the items to the unobstructed spray from all cycles; and

2. Allows the items to drain.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1840 Wet cleaning

A. Equipment food-contact surfaces and utensils shall be effectively washed to remove or completely loosen soils by using the manual or mechanical means necessary such as the application of detergents containing wetting agents and emulsifiers; acid, alkaline, or abrasive cleaners; hot water; brushes; scouring pads; high-pressure sprays; or ultrasonic devices.

B. The washing procedures selected shall be based on the type and purpose of the equipment or utensil, and on the type of soil to be removed.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1850 Washing, procedures for alternative manual warewashing equipment

If washing in sink compartments or a warewashing machine is impractical such as when the equipment is fixed or the utensils are too large, washing shall be done by using alternative manual warewashing equipment as specified in 12VAC5-421-1460 C in accordance with the following procedures:

1. Equipment shall be disassembled as necessary to allow access of the detergent solution to all parts;

2. Equipment components and utensils shall be scrapped or rough cleaned to remove food particle accumulation; and

3. Equipment and utensils shall be washed as specified under 12VAC5-421-1840 A.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1860 Rinsing procedures

Washed utensils and equipment shall be rinsed so that abrasives are removed and cleaning chemicals are removed or diluted through the use of water or a detergent-sanitizer solution by using one of the following procedures:

1. Use of a distinct, separate water rinse after washing and before sanitizing if using:

a. A 3-compartment sink,

b. Alternative manual warewashing equipment equivalent to a 3-compartment sink as specified in 12VAC5-421-1460 C, or

c. A 3-step washing, rinsing, and sanitizing procedure in a warewashing system for CIP equipment;

2. Use of a detergent-sanitizer as specified under 12VAC5-421-1710 if using:

a. Alternative warewashing equipment as specified in 12VAC5-421-1460 C that is approved for use with a detergent-sanitizer, or

b. A warewashing system for CIP equipment;

3. Use of a nondistinct water rinse that is integrated in the hot water sanitization immersion step of a 2-compartment sink operation;

4. If using a warewashing machine that does not recycle the sanitizing solution as specified under subdivision 5 of this section, or alternative manual warewashing equipment such as sprayers, use of a nondistinct water rinse that is:

a. Integrated in the application of the sanitizing solution, and

b. Wasted immediately after each application; or

5. If using a warewashing machine that recycles the sanitizing solution for use in the next wash cycle, use of a nondistinct water rinse that is integrated in the application of the sanitizing solution.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1870 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; repealed, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-1880 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; repealed, Volume 26, Issue 7, eff. January 1, 2010.

Article 7 Sanitization of Equipment and Utensils

12VAC5-421-1885 Food-contact surfaces and utensils

Equipment food-contact surfaces and utensils shall be sanitized.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-1890 Before use after cleaning

Utensils and food-contact surfaces of equipment shall be sanitized before use after cleaning.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-1900 Hot water and chemical

After being cleaned, equipment food-contact surfaces and utensils shall be sanitized in:

1. Hot water manual operations by immersion for at least 30 seconds as specified under 12VAC5-421-1670;^P

2. Hot water mechanical operations by being cycled through equipment that is set up as specified under 12VAC5-421-1610, 12VAC5-421-1680, and 12VAC5-421-1690 and achieving a utensil surface temperature of 160°F (71°C) as measured by an irreversible registering temperature indicator;^P or

3. Chemical manual or mechanical operations, including the application of sanitizing chemicals by immersion, manual swabbing, brushing, or pressure spraying methods, using a solution as specified under 12VAC5-421-1700. Contact times shall be consistent with those on EPA-registered label use instructions by providing:

a. Except as specified under subdivision 3 b of this section, a contact time of at least 10 seconds for a chlorine solution specified under subdivision 1 of 12VAC5-421-1700;^P

b. A contact time of at least 7 seconds for a chlorine solution of 50 mg/L that has a pH of 10 or less and a temperature of at least 100°F (38°C) or a pH of 8 or less and a temperature of at least 75°F (24°C);^P

c. A contact time of at least 30 seconds for other chemical sanitizing solutions;^P or

d. A contact time used in relationship with a combination of temperature, concentration, and pH that, when evaluated for efficacy, yields sanitization as defined in 12VAC5-421-10.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

Article 8 Laundering

12VAC5-421-1910 Clean linens

Clean linens shall be free from food residues and other soiling matter.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1920 Laundering frequency for linens, cloth gloves, napkins, and wiping cloths

A. Linens that do not come in direct contact with food shall be laundered between operations if they become wet, sticky, or visibly soiled.

B. Cloth gloves used as specified in 12VAC5-421-580 D shall be laundered before being used with a different type of raw animal food such as beef, fish, lamb, pork, and poultry.

C. Linens that are used as specified under 12VAC5-421-560 and cloth napkins shall be laundered between each use.

D. Wet wiping cloths shall be laundered daily.

E. Dry wiping cloths shall be laundered as necessary to prevent contamination of food and clean serving utensils.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-1930 Storage of soiled linens

Soiled linens shall be kept in clean, nonabsorbent receptacles or clean, washable laundry bags and stored and transported to prevent contamination of food, clean equipment, clean utensils, and single-service and single-use articles.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1940 Mechanical washing

A. Except as specified in subsection B of this section, linens shall be mechanically washed.

B. In food establishments in which only wiping cloths are laundered as specified in 12VAC5-421-1490 B, the wiping cloths may be laundered in a mechanical washer, sink designated only for laundering wiping cloths, or a warewashing or food preparation sink that is cleaned as specified under 12VAC5-421-1600.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1950 Use of laundry facilities

A. Except as specified in subsection B of this section, laundry facilities on the premises of a food establishment shall be used only for the washing and drying of items used in the operation of the establishment.

B. Separate laundry facilities located on the premises for the purpose of general laundering such as for institutions providing boarding and lodging may also be used for laundering food establishment items.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

Article 9 Protection of Clean Items

12VAC5-421-1960 Equipment and utensils, air-drying required

Article 9 Protection of Clean Items

After cleaning and sanitizing, equipment and utensils:

1. Shall be air dried or used after adequate draining as specified in 40 CFR 180.940 before contact with food; and

2. Shall not be cloth dried except that utensils that have been air-dried may be polished with cloths that are maintained clean and dry.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007.

12VAC5-421-1970 Wiping cloths, air-drying locations

Wiping cloths laundered in a food establishment that does not have a mechanical clothes dryer as specified in 12VAC5-421-1490 B shall be air-dried in a location and in a manner that prevents contamination of food, equipment, utensils, linens, and single-service and single-use articles and the wiping cloths. This section does not apply if wiping cloths are stored after laundering in a sanitizing solution as specified under 12VAC5-421-1700.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-1980 Food-contact surfaces

Lubricants as specified in 12VAC5-421-3420 shall be applied to food-contact surfaces that require lubrication in a manner that does not contaminate food-contact surfaces.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 26, Issue 7, eff. January 1, 2010.

12VAC5-421-1990 Equipment

Equipment shall be reassembled so that food-contact surfaces are not contaminated.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2000 Equipment, utensils, linens, and single-service and single-use articles

A. Except as specified in subsection D of this section, cleaned equipment and utensils, laundered linens, and single-service and single-use articles shall be stored:

1. In a clean, dry location;

2. Where they are not exposed to splash, dust, or other contamination; and

3. At least six inches (15 cm) above the floor.

B. Clean equipment and utensils shall be stored as specified under subsection A of this section and shall be stored:

1. In a self-draining position that allows air drying; and

2. Covered or inverted.

C. Single-service and single-use articles shall be stored as specified under subsection A of this section and shall be kept in the original protective package or stored by using other means that afford protection from contamination until used.

D. Items that are kept in closed packages may be stored less than 6 inches (15 cm) above the floor on dollies, pallets, racks, and skids that are designed as provided under 12VAC5-421-1420.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2010 Prohibitions

A. Cleaned and sanitized equipment, utensils, laundered linens, and single-service and single-use articles may not be stored:

1. In locker rooms, except pursuant to subsection B of this section;

2. In toilet rooms or vestibules;^Pf

3. In garbage rooms;

4. In mechanical rooms;

5. Under sewer lines that are not shielded to intercept potential drips;

6. Under leaking water lines including leaking automatic fire sprinkler heads or under lines on which water has condensed;

7. Under open stairwells; or

8. Under other sources of contamination.

B. Laundered linens and single-service and single-use articles that are packaged or in a facility such as a cabinet may be stored in a locker room.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-2020 Kitchenware and tableware

A. Single-service and single-use articles and cleaned and sanitized utensils shall be handled, displayed, and dispensed so that contamination of food- and lip-contact surfaces is prevented.

B. Knives, forks, and spoons that are not prewrapped shall be presented so that only the handles are touched by employees and by consumers if consumer self-service is provided.

C. Except as specified under subsection B of this section, single-service articles that are intended for food- or lip-contact shall be furnished for consumer self-service with the original individual wrapper intact or from an approved dispenser.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2030 Soiled and clean tableware

Soiled tableware shall be removed from consumer eating and drinking areas and handled so that clean tableware is not contaminated.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2040 Preset tableware

A. Except as specified in subsection B of this section, tableware that is preset shall be protected from contamination by being wrapped, covered, or inverted.

B. Preset tableware may be exposed if:

1. Unused settings are removed when a consumer is seated; or

2. Settings not removed when a consumer is seated are cleaned and sanitized before further use.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-2045 Rinsing equipment and utensils after cleaning and sanitizing

After being cleaned and sanitized, equipment and utensils shall not be rinsed before air drying or used unless:

1. The rinse is applied directly from a potable water supply by a warewashing machine that is maintained and operated as specified under Articles 2 (12VAC5-421-1080 et seq.) and 5 (12VAC5-421-1570) of this part; and

2. The rinse is applied only after the equipment and utensils have been sanitized by the application of hot water or by the application of a chemical sanitizer solution whose EPA-registered label use instructions call for rinsing off the sanitizer after it is applied in a commercial warewashing machine.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

Article 1 Water

12VAC5-421-2050 Approved system

Pure water shall be obtained from an approved water system defined as:

1. A waterworks constructed, maintained, and operated in compliance with 12VAC5-590;^P or

2. A private well constructed, maintained, and operated in compliance with 12VAC5-630.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-2060 System flushing and disinfection

An approved water system shall be flushed and disinfected after construction, repair, or modification and after an emergency situation, such as a flood, that may introduce contaminants to the system. A sample shall be collected from the water system and the results of the analysis shall be total coliform negative prior to placing the water system into service.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-2070 Bottled drinking water

Bottled drinking water used or sold in a food establishment shall be obtained from approved sources in accordance with 21 CFR Part 129.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-2080 Pure water standards

Except as specified under 12VAC5-421-2090:

1. Water from a waterworks shall meet water quality and quantity standards in accordance with 12VAC5-590;^P and

2. Water from a private well shall meet the water quality standards in accordance with 12VAC5-630-370 and not exceed 10 mg/L of nitrate (as N).^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-2090 Nonpotable water

A. A nonpotable water supply shall be used only if its use is approved by the department.^P

B. Nonpotable water shall be used only for nonculinary purposes such as air conditioning, nonfood equipment cooling, and fire protection.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-2100 Sampling

Water from a private well shall be sampled and tested at least annually for nitrate and total coliform.^Pf

1. If nitrate, which is reported as "N" on the test results, exceeds 10 mg/L (ppm), the owner shall notify the department within 24 hours from when the owner is notified of the nitrate positive test result.^Pf

2. If a sample is total coliform positive, the positive culture medium shall be further analyzed to determine if E. coli is present. The owner shall notify the department within two calendar days from when the owner is notified of the coliform positive test result.^Pf

3. If E. coli is present, the owner shall notify the department within 24 hours from when the owner is notified of the E. coli positive test result.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-2110 Sample report

All sample reports for the private well shall be retained on file in the food establishment for a minimum of five years and be made available to the department upon request.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-2120 Capacity

A. The approved water system capacity shall be of sufficient capacity to meet the maximum daily water demands and the peak hourly water demands of the food establishment.^Pf

B. Hot water generation and distribution systems shall meet the peak hot water demands throughout the food establishment.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-2130 Pressure

Water under pressure shall be provided to all fixtures, equipment, and nonfood equipment that are required to use water except that water supplied as specified under subdivisions 1 and 2 of 12VAC5-421-2160 to a temporary food establishment or in response to a temporary interruption of a water supply need not be under pressure.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-2140 Water System

Water shall be received from the source through the use of:

1. An approved public water main;^Pf or

2. One or more of the following that shall be constructed, maintained, and operated according to law: ^Pf

a. Nonpublic water main, water pumps, pipes, hoses, connections, and other appurtenances;^Pf

b. Water transport vehicles;^Pf or

c. Water containers.^Pf

12VAC5-421-2150 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; repealed, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-2160 Alternative water supply

Water meeting the requirements specified under 12VAC5-421-2050 through 12VAC5-421-2130 shall be made available for a mobile facility, for a temporary food establishment without a permanent water supply, and for a food establishment with a temporary interruption of its water supply through:

1. A supply of containers of commercially bottled drinking water;^Pf

2. One or more closed portable water containers;^Pf

3. An enclosed vehicular water tank;^Pf

4. An on-premises water storage tank;^Pf or

5. Piping, tubing, or hoses connected to an adjacent approved system in a manner approved by the department.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

Article 2 Plumbing System

12VAC5-421-2170 Approved materials

A. A plumbing system and hoses conveying water shall be constructed and repaired with approved materials according to law.^P

B. A water filter shall be made of safe materials.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-2180 Approved system and cleanable fixtures

A. A plumbing system shall be designed, constructed, and installed according to law.^P

B. A plumbing fixture such as a handwashing lavatory, toilet, or urinal shall be easily cleanable.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-2190 Handwashing sinks, water temperature, and flow

A. A handwashing sink shall be equipped to provide water at a temperature of at least 85°F (29.4°C) through a mixing valve or combination faucet.^Pf

B. A steam mixing valve may not be used at a handwashing sink.

C. A self-closing, slow-closing, or metering faucet shall provide a flow of water for at least 15 seconds without the need to reactivate the faucet.

D. An automatic handwashing facility shall be installed in accordance with the manufacturer's instructions.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016; Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-2200 Backflow prevention, air gap

An air gap between the water supply inlet and the flood level rim of the plumbing fixture, equipment, or nonfood equipment shall be at least twice the diameter of the water supply inlet and shall not be less than one inch (25 mm).^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-2210 Backflow prevention device, design standard

A backflow or backsiphonage prevention device installed on a water supply system shall comply with the Virginia Uniform Statewide Building Code (13VAC5-63) for construction, installation, maintenance, inspection, and testing for that specific application and type of device.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-2220 Conditioning device, design

A water filter, screen, and other water conditioning device installed on water lines shall be designed to facilitate disassembly for periodic servicing and cleaning. A water filter element shall be of the replaceable type.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2230 Handwashing sinks, numbers, and capacities

A. Except as specified in subsection B and C of this section, at least one handwashing sink, or the number of handwashing sinks necessary for their convenient use by employees in areas specified under 12VAC5-421-2280, and not fewer than the number of handwashing sinks required by law shall be provided.^Pf

B. If approved and capable of removing the types of soils encountered in the food operations involved, automatic handwashing facilities may be substituted for handwashing sinks in a food establishment that has at least one handwashing sink.

C. If approved, when food exposure is limited and handwashing sinks are not conveniently available, such as in some mobile or temporary food establishments or at some vending machine locations, employees may use chemically treated towelettes for handwashing.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-2240 Toilets and urinals

At least one toilet and not fewer than the toilets required by law shall be provided. If authorized by law and urinals are substituted for toilets, the substitution shall be done as specified in law.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2250 Service sink

A. At least one service sink or one curbed cleaning facility equipped with a floor drain shall be provided and conveniently located for the cleaning of mops or similar wet floor cleaning tools and for the disposal of mop water and similar liquid waste.

B. Toilets and urinals shall not be used as a service sink for the disposal of mop water and similar liquid waste.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-2260 Backflow prevention device, when required

A plumbing system shall be installed to preclude backflow of a solid, liquid, or gas contaminant into the water supply system at each point of use at the food establishment, including on a hose bibb (threaded faucet) if a hose is attached or on a hose bibb if a hose is not attached and backflow prevention is required by law by:

1. Providing an air gap as specified under 12VAC5-421-2200;^P or

2. Installing an approved backflow prevention device as specified under 12VAC5-421-2210.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-2270 Backflow prevention device, carbonator

A. If not provided with an air gap as specified under 12VAC5-421-2200, a dual check valve with an intermediate vent preceded by a screen of not less than 100 mesh to 1 inch (100 mesh to 25.4mm) shall be installed upstream from a carbonating device and downstream from any copper in the water supply line.^P

B. A dual check valve attached to the carbonator need not be of the vented type if an air gap or vented backflow prevention device has been otherwise provided as specified under subsection A of this section.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 2, eff. October 16, 2007; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-2280 Handwashing sinks, location

A handwashing sink shall be located:

1. To allow convenient use by employees in food preparation, food dispensing, and warewashing areas;^Pf and

2. In, or immediately adjacent to, toilet rooms.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-2290 Backflow prevention device, location

A backflow prevention device shall be located so that it may be serviced and maintained.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2300 Conditioning device, location

A water filter, screen, and other water conditioning device installed on water lines shall be located to facilitate disassembly for periodic servicing and cleaning.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2310 Using a handwashing sink

A. A handwashing sink shall be maintained so that it is accessible at all times for employee use.^Pf

B. A handwashing sink shall not be used for purposes other than handwashing.^Pf

C. An automatic handwashing facility shall be used in accordance with manufacturer's instructions.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-2320 Prohibiting a cross connection

A. A person shall not create a cross connection by connecting a pipe or conduit between the drinking water system and a nondrinking water system or a water system of unknown quality.^P

B. The piping of a nondrinking water system shall be durably identified so that it is readily distinguishable from piping that carries drinking water.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-2330 Scheduling inspection and service for a water system device

A device such as a water treatment device or backflow preventer shall be scheduled for inspection and service, in accordance with manufacturer's instructions and as necessary to prevent device failure based on local water conditions, and records demonstrating inspection and service shall be maintained by the person in charge for a minimum of five years and made available to the department upon request.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-2340 Water reservoir of fogging devices, cleaning

A. A reservoir that is used to supply water to a device such as a produce fogger shall be:

1. Maintained in accordance with manufacturer's specifications;^Pand

2. Cleaned in accordance with manufacturer's specifications or according to the procedures specified under subsection B of this section, whichever is more stringent.^P

B. Cleaning procedures shall include at least the following steps and shall be conducted at least once a week:

1. Draining and complete disassembly of the water and aerosol contact parts;^P

2. Brush-cleaning the reservoir, aerosol tubing, and discharge nozzles with a suitable detergent solution;^P

3. Flushing the complete system with water to remove the detergent solution and particulate accumulation;^P and

4. Rinsing by immersing, spraying, or swabbing the reservoir, aerosol tubing, and discharge nozzles with at least 50 mg/L (ppm) hypochlorite solution.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-2350 System maintained in good repair

A plumbing system shall be :

1. Repaired according to law;^P and

2. Maintained in good repair.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

Article 3 Mobile Water Tank and Mobile Food Establishment Water Tank

12VAC5-421-2360 Mobile water tank approved materials

Materials that are used in the construction of a mobile water tank, mobile food establishment water tank, and appurtenances shall be:

1. Safe;^P

2. Durable, corrosion resistant, and nonabsorbent; and

3. Finished to have a smooth, easily cleanable surface.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-2370 Enclosed system, sloped to drain

A mobile water tank shall be:

1. Enclosed from the filling inlet to the discharge outlet; and

2. Sloped to an outlet that allows complete drainage of the tank.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2380 Inspection and cleaning port, protected and secured

If a water tank is designed with an access port for inspection and cleaning, the opening shall be in the top of the tank and:

1. Flanged upward at least one-half inch (13 mm); and

2. Equipped with a port cover assembly that is:

a. Provided with a gasket and a device for securing the cover in place, and

b. Flanged to overlap the opening and sloped to drain.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2390 "V" type threads, use limitation

A fitting with "V" type threads on a water tank inlet or outlet shall be allowed only when a hose is permanently attached.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2400 Tank vent, protected

If provided, a water tank vent shall terminate in a downward direction and shall be covered with:

1. 16 mesh to 1-inch (16 mesh to 25.4 mm) screen or equivalent when the vent is in a protected area; or

2. A protective filter when the vent is in an area that is not protected from windblown dirt and debris.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2410 Inlet and outlet, sloped to drain

A. A water tank and its inlet and outlet shall be sloped to drain.

B. A water tank inlet shall be positioned so that it is protected from contaminants such as waste discharge, road dust, oil, or grease.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2420 Hose, construction and identification

A hose used for conveying potable water from a water tank shall be:

1. Safe;^P

2. Durable, corrosion resistant, and nonabsorbent;

3. Resistant to pitting, chipping, crazing, scratching, scoring, distortion, and decomposition;

4. Finished with a smooth interior surface; and

5. Clearly and durably identified as to its use if not permanently attached.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-2430 Filter, compressed air

A filter that does not pass oil or oil vapors shall be installed in the air supply line between the compressor and potable water system when compressed air is used to pressurize the water tank system.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-2440 Protective cover or device

A cap and keeper chain, closed cabinet, closed storage tube, or other approved protective cover or device shall be provided for a water inlet, outlet, and hose.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2450 Mobile food establishment tank inlet

A mobile food establishment's water tank inlet shall be:

1. Three-fourths inch (19.1 mm) in inner diameter or less; and

2. Provided with a hose connection of a size or type that will prevent its use for any other service.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2460 System flushing and disinfection

A water tank, pump, and hoses shall be flushed and sanitized before being placed in service after construction, repair, modification, and periods of nonuse.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-2470 Using a pump and hoses, backflow prevention

A person shall operate a water tank, pump, and hoses so that backflow and other contamination of the water supply are prevented.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2480 Protecting inlet, outlet, and hose fitting

If not in use, a water tank and hose inlet and outlet fitting shall be protected using a cover or device as specified under 12VAC5-421-2440.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2490 Tank, pump, and hoses, dedication

A. Except as specified in subsection B of this section, a water tank, pump, and hoses used for conveying drinking water shall be used for no other purpose.^P

B. Water tanks, pumps, and hoses approved for liquid foods may be used for conveying drinking water if they are cleaned and sanitized before they are used to convey water.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

Article 4 Sewage, Other Liquid Waste, and Rainwater

12VAC5-421-2500 Mobile holding tank capacity and drainage

A sewage holding tank in a mobile food establishment shall be:

1. Sized 15% larger in capacity than the water supply tank; and

2. Sloped to a drain that is 1 inch (25 mm) in inner diameter or greater, equipped with a shut-off valve.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2505 Establishment drainage system

Food establishment drainage systems, including grease traps, that convey sewage shall be designed and installed as specified under 12VAC5-421-2180 A.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-2510 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; repealed, Virginia Register Volume 26, Issue 7, eff. January 1, 2010.

12VAC5-421-2520 Backflow prevention

A. Except as specified in subsections B, C, and D of this section, a direct connection may not exist between the sewage system and a drain originating from equipment in which food, portable equipment, or utensils are placed.^P

B. Subsection A of this section does not apply to floor drains that originate in refrigerated spaces that are constructed as an integral part of the building.

C. If allowed by law, a warewashing machine may have a direct connection between its waste outlet and a floor drain when the machine is located within five feet (1.5 meters) of a trapped floor drain and the machine outlet is connected to the inlet side of a properly vented floor drain trap.

D. If allowed by law, a warewashing or culinary sink may have a direct connection.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-2530 Grease trap

If used, a grease trap shall be located to be easily accessible for cleaning.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2540 Conveying sewage

Sewage shall be conveyed to the point of disposal through an approved sanitary sewage system or other system, including use of sewage transport vehicles, waste retention tanks, pumps, pipes, hoses, and connections that are constructed, maintained, and operated according to law.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-2550 Removing mobile food establishment wastes

No public health hazard or nuisance shall result when sewage and other liquid wastes are removed from a mobile food establishment at an approved waste servicing area or by a permitted sewage transport vehicle.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-2560 Flushing a waste retention tank

A tank for liquid waste retention shall be thoroughly flushed and drained in a sanitary manner during the servicing operation.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2570 Approved sewage disposal system

Sewage shall be disposed through an approved facility that is:

1. A public sewage treatment plant;^P or

2. An individual sewage disposal system that is sized, constructed, maintained, and operated according to the State Board of Health's regulations promulgated pursuant to Chapter 6 (§ 32.1-163 et seq.) of Title 32 of the Code of Virginia, including 12VAC5-610, Sewage Handling and Disposal Regulations, 12VAC5-613, Regulations for Alternative Onsite Sewage Systems, or otherwise according to law.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-2580 Other liquid wastes and rainwater

Condensate drainage and other nonsewage liquids and rainwater shall be drained from point of discharge to disposal according to law.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2590 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; repealed, Virginia Register Volume 26, Issue 7, eff. January 1, 2010.

Article 5 Refuse, Recyclables, and Returnables

12VAC5-421-2600 Outdoor storage surface

An outdoor storage surface for refuse, recyclables, and returnables shall be constructed of nonabsorbent material such as concrete or asphalt and shall be smooth, durable, and sloped to drain.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2610 Outdoor enclosure

If used, an outdoor enclosure for refuse, recyclables, and returnables shall be constructed of durable and cleanable materials.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2620 Receptacles

A. Except as specified in subsection B of this section, receptacles and waste handling units for refuse, recyclables, and returnables and for use with materials containing food residue shall be durable, cleanable, insect- and rodent-resistant, leakproof, and nonabsorbent.

B. Plastic bags and wet strength paper bags may be used to line receptacles for storage inside the food establishment, or within closed outside receptacles.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2630 Receptacles in vending machines

Except for a receptacle for a beverage bottle crown closures, a refuse receptacle may not be located within a vending machine.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010.

12VAC5-421-2640 Outside receptacles

A. Receptacles and waste handling units for refuse, recyclables, and returnables used with materials containing food residue and used outside the food establishment shall be designed and constructed to have tight-fitting lids, doors, or covers.

B. Receptacles and waste handling units for refuse and recyclables such as an on-site compactor shall be installed so that accumulation of debris and insect and rodent attraction and harborage are minimized and effective cleaning is facilitated around and, if the unit is not installed flush with the base pad, under the unit.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2650 Storage areas, rooms, and receptacles, capacity and availability

A. An inside storage room and area and outside storage area and enclosure, and receptacles shall be of sufficient capacity to hold refuse, recyclables, and returnables that accumulate.

B. A receptacle shall be provided in each area of the food establishment or premises where refuse is generated or commonly discarded, or where recyclables or returnables are placed.

C. If disposable towels are used at handwashing lavatories, a waste receptacle shall be located at each lavatory or group of adjacent lavatories.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2660 Toilet room receptacle, covered

A toilet room used by females shall be provided with a covered receptacle for sanitary napkins.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2670 Cleaning implements and supplies

A. Except as specified in subsection B of this section, suitable cleaning implements and supplies such as high pressure pumps, hot water, steam, and detergent shall be provided as necessary for effective cleaning of receptacles and waste handling units for refuse, recyclables, and returnables.

B. If approved, off-premises-based cleaning services may be used if on-premises cleaning implements and supplies are not provided.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2680 Storage areas, redeeming machines, receptacles and waste handling units, location

A. An area designated for refuse, recyclables, returnables, and, except as specified in subsection B of this section, a redeeming machine for recyclables or returnables shall be located so that it is separate from food, equipment, utensils, linens, and single-service and single-use articles and a public health hazard or nuisance is not created.

B. A redeeming machine may be located in the packaged food storage area or consumer area of a food establishment if food, equipment, utensils, linens, and single-service and single-use articles are not subject to contamination from the machines and a public health hazard or nuisance is not created.

C. The location of receptacles and waste handling units for refuse, recyclables, and returnables shall not create a public health hazard or nuisance or interfere with the cleaning of adjacent space.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007.

12VAC5-421-2690 Storing refuse, recyclables, and returnables

Refuse, recyclables, and returnables shall be stored in receptacles or waste handling units so that they are inaccessible to insects and rodents.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2700 Areas, enclosures, and receptacles, good repair

Storage areas, enclosures, and receptacles for refuse, recyclables, and returnables shall be maintained in good repair.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2710 Outside storage prohibitions

A. Except as specified in subsection B of this section, refuse receptacles not meeting the requirements specified under 12VAC5-421-2620 A such as receptacles that are not rodent-resistant, unprotected plastic bags and paper bags, or baled units that contain materials with food residue shall not be stored outside.

B. Cardboard or other packaging material that does not contain food residues and that is awaiting regularly scheduled delivery to a recycling or disposal site may be stored outside without being in a covered receptacle if it is stored so that it does not create a rodent harborage problem.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007.

12VAC5-421-2720 Covering receptacles

Receptacles and waste handling units for refuse, recyclables, and returnables shall be kept covered:

1. Inside the food establishment if the receptacles and units :

a. Contain food residue and are not in continuous use; or

b. After they are filled; and

2. With tight-fitting lids or doors if kept outside the food establishment.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021; Errata, 41:5 VA.R. 734 October 21, 2024.

12VAC5-421-2730 Using drain plugs

Drains in receptacles and waste handling units for refuse, recyclables, and returnables shall have drain plugs in place.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2740 Maintaining refuse areas and enclosures

A storage area and enclosure for refuse, recyclables, or returnables shall be maintained free of unnecessary items, as specified under 12VAC5-421-3300, and clean.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2750 Cleaning receptacles

A. Receptacles and waste handling units for refuse, recyclables, and returnables shall be thoroughly cleaned in a way that does not contaminate food, equipment, utensils, linens, or single-service and single-use articles, and waste water shall be disposed of as specified under 12VAC5-421-2540.

B. Soiled receptacles and waste handling units for refuse, recyclables, and returnables shall be cleaned at a frequency necessary to prevent them from developing a buildup of soil or becoming attractants for insects and rodents.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-2760 Removal frequency

Refuse, recyclables, and returnables shall be removed from the premises at a frequency that will minimize the development of objectionable odors and other conditions that attract or harbor insects and rodents.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2770 Receptacles or vehicles

Refuse, recyclables, and returnables shall be removed from the premises by way of:

1. Portable receptacles that are constructed and maintained according to law; or

2. A transport vehicle that is constructed, maintained, and operated according to law.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2780 Community or individual facility

Solid waste not disposed of through the sewage system such as through grinders and pulpers shall be recycled or disposed of in an approved public or private community recycling or refuse facility; or solid waste shall be disposed of in an individual refuse facility such as a landfill or incinerator which is sized, constructed, maintained, and operated according to law.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

Article 1 Materials for Construction and Repair

12VAC5-421-2790 Indoor areas; surface characteristics

A. Except as specified in subsection B of this section, materials for indoor floor, wall, and ceiling surfaces under conditions of normal use shall be:

1. Smooth, durable, and easily cleanable for areas where food establishment operations are conducted;

2. Closely woven and easily cleanable carpet for carpeted areas; and

3. Nonabsorbent for areas subject to moisture such as food preparation areas, walk-in refrigerators, warewashing areas, toilet rooms, mobile food establishment servicing areas, and areas subject to flushing or spray cleaning methods.

B. In a temporary food establishment:

1. A floor may be concrete, if graded to drain, machine-laid asphalt, or dirt or gravel if it is covered with mats, removable platforms, duckboards, or other approved materials that are effectively treated to control dust and mud; and

2. Walls and ceilings may be constructed of a material that protects the interior from the weather and windblown dust and debris.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010.

12VAC5-421-2800 Outdoor areas; surface characteristics

A. The outdoor walking and driving areas shall be surfaced with concrete, asphalt, or gravel or other materials that have been effectively treated to minimize dust, facilitate maintenance, and prevent muddy conditions.

B. Exterior surfaces of buildings and mobile food establishments shall be of weather-resistant materials and shall comply with law.

C. Outdoor storage areas for refuse, recyclables, or returnables shall be of materials specified under 12VAC5-421-2600 and 12VAC5-421-2610.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

Article 2 Design, Construction, and Installation

12VAC5-421-2810 Floors, walls, and ceilingscleanability

Except as specified under 12VAC5-421-2840 and except for anti-slip floor coverings or applications that may be used for safety reasons, floors, floor coverings, walls, wall coverings, and ceilings shall be designed, constructed, and installed so they are smooth and easily cleanable.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010.

12VAC5-421-2820 Floors, walls, and ceilings, utility lines

A. Utility service lines and pipes shall not be unnecessarily exposed.

B. Exposed utility service lines and pipes shall be installed so they do not obstruct or prevent cleaning of the floors, walls, or ceilings.

C. Exposed horizontal utility service lines and pipes shall not be installed on the floor.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007.

12VAC5-421-2830 Floor and wall junctures, coved, and enclosed or sealed

A. In food establishments in which cleaning methods other than water flushing are used for cleaning floors, the floor and wall junctures shall be coved and closed to no larger than 1/32 inch (1 mm). However, this subsection shall not apply to floor wall junctures in bed and breakfast operations serving 18 or fewer guests.

B. The floors in food establishments in which water flush cleaning methods are used shall be provided with drains and be graded to drain, and the floor and wall junctures shall be coved and sealed.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 35, Issue 1, eff. October 3, 2018.

12VAC5-421-2840 Floor carpeting, restrictions and installation

A. A floor covering such as carpeting or similar material shall not be installed as a floor covering in food preparation areas, walk-in refrigerators, warewashing areas, toilet room areas where handwashing lavatories, toilets, and urinals are located, refuse storage rooms, or other areas where the floor is subject to moisture, flushing, or spray cleaning methods.

B. If carpeting is installed as a floor covering in areas other than those specified under subsection A of this section, it shall be:

1. Securely attached to the floor with a durable mastic, by using a stretch and tack method, or by another method; and

2. Installed tightly against the wall under the coving or installed away from the wall with a space between the carpet and the wall and with the edges of the carpet secured by metal stripping or some other means.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007.

12VAC5-421-2850 Floor covering, mats and duckboards

Mats and duckboards shall be designed to be removable and easily cleanable.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007.

12VAC5-421-2860 Wall and ceiling coverings and coatings

A. Wall and ceiling covering materials shall be attached so that they are easily cleanable.

B. Except in areas used only for dry storage, concrete, porous blocks, or bricks used for indoor wall construction shall be finished and sealed to provide a smooth, nonabsorbent, easily cleanable surface.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2870 Walls and ceilings, attachments

A. Except as specified in subsection B of this section, attachments to walls and ceilings such as light fixtures, mechanical room ventilation system components, vent covers, wall mounted fans, decorative items, and other attachments shall be easily cleanable.

B. In a consumer area, wall and ceiling surfaces and decorative items and attachments that are provided for ambiance need not meet this requirement if they are kept clean.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007.

12VAC5-421-2880 Walls and ceilings, studs, joists, and rafters

Studs, joists, and rafters shall not be exposed in areas subject to moisture. This requirement does not apply to temporary food establishments.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007.

12VAC5-421-2890 Light bulbs, protective shielding

A. Except as specified in subsection B of this section, light bulbs shall be shielded, coated, or otherwise shatter-resistant in areas where there is exposed food; clean equipment, utensils, and linens; or unwrapped single-service and single-use articles.

B. Shielded, coated, or otherwise shatter-resistant bulbs need not be used in areas used only for storing food in unopened packages, if:

1. The integrity of the packages can not be affected by broken glass falling onto them; and

2. The packages are capable of being cleaned of debris from broken bulbs before the packages are opened.

C. An infrared or other heat lamp shall be protected against breakage by a shield surrounding and extending beyond the bulb so that only the face of the bulb is exposed.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2900 Heating, ventilating, air conditioning system vents

Heating, ventilating, and air conditioning systems shall be designed and installed so that make-up air intake and exhaust vents do not cause contamination of food, food-contact surfaces, equipment, or utensils.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2910 Insect control devices, design and installation

A. Insect control devices that are used to electrocute or stun flying insects shall be designed to retain the insect within the device.

B. Insect control devices shall be installed so that:

1. The devices are not located over a food preparation area; and

2. Dead insects and insect fragments are prevented from being impelled onto or falling on exposed food; clean equipment, utensils, and linens; and unwrapped single-service and single-use articles.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2920 Toilet rooms, enclosed

Except where a toilet room is located outside a food establishment and does not open directly into the food establishment such as a toilet room that is provided by the management of a shopping mall, a toilet room located on the premises shall be completely enclosed and provided with a tight-fitting and self-closing door.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 26, Issue 7, eff. January 1, 2010.

12VAC5-421-2930 Outer openings, protected

A. Except as specified in subsections B through E of this section, outer openings of a food establishment shall be protected against the entry of insects and rodents by:

1. Filling or closing holes and other gaps along floors, walls and ceilings;

2. Closed, tight-fitting windows; and

3. Solid self-closing, tight-fitting doors.

B. Subsection A of this section does not apply if a food establishment opens into a larger structure, such as a mall, airport, or office building, or into an attached structure, such as a porch, and the outer openings from the larger or attached structure are protected against the entry of insects and rodents.

C. Exterior doors used as exits need not be self-closing if they are:

1. Solid and tight-fitting;

2. Designated for use only when an emergency exists, by the fire protection authority that has jurisdiction over the food establishment; and

3. Restricted so they are not used for entrance or exit from the building for purposes other than the designated emergency exit use.

D. Except as specified in subsections B and E of this section, if the windows or doors of a food establishment, or of a larger structure within which a food establishment is located, are kept open for ventilation or other purposes, the openings shall be protected against the entry of insects and rodents by:

1. 16 mesh to 1-inch (16 mesh to 25.4 mm) screens;

2. Properly designed and installed air curtains to control flying insects; or

3. Other effective means.

E. Subsection D of this section does not apply if flying insects and other pests are absent due to the location of the establishment, the weather, or other limiting condition.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007.

12VAC5-421-2940 Exterior walls and roofs, protective barrier

Perimeter walls and roofs of a food establishment shall effectively protect the establishment from the weather and the entry of insects, rodents, and other animals.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2950 Outdoor food vending areas, overhead protection

Except for machines that vend canned beverages, if located outside, a machine used to vend food shall be provided with overhead protection.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 26, Issue 7, eff. January 1, 2010.

12VAC5-421-2960 Outdoor servicing areas, overhead protection

Except for areas used only for the loading of water or the discharge of sewage or other liquid waste, through the use of a closed system of hoses, servicing areas shall be provided with overhead protection.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 26, Issue 7, eff. January 1, 2010.

12VAC5-421-2970 Outdoor walking and driving surfaces, graded to drain

Exterior walking and driving surfaces shall be graded to drain.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2980 Outdoor refuse areas, curbed and graded to drain

Outdoor refuse areas shall be constructed in accordance with law and shall be curbed and graded to drain to collect and dispose of liquid waste that results from the refuse and from cleaning the area and waste receptacles.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-2990 Private homes and living or sleeping quarters, use prohibition

A private home, a room used as living or sleeping quarters, or an area directly opening into a room used as living or sleeping quarters shall not be used for conducting food establishment operations.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-3000 Living or sleeping quarters, separation

Living or sleeping quarters located on the premises of a food establishment such as those provided for lodging registration clerks or resident managers shall be separated from rooms and areas used for food establishment operations by complete partitioning and solid self-closing doors.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-3010 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; repealed, Virginia Register Volume 26, Issue 7, eff. January 1, 2010.

Article 3 Numbers and Capacities

12VAC5-421-3020 Handwashing cleanser, availability

Article 3 Numbers and Capacities

Each handwashing sink or group of two adjacent handwashing sinks shall be provided with a supply of hand cleaning liquid, powder, or bar soap.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-3030 Hand drying provision

Each handwashing sink or group of adjacent handwashing sinks shall be provided with:

1. Individual, disposable towels;^Pf

2. A continuous towel system that supplies the user with a clean towel; ^Pf

3. A heated-air hand drying device;^Pfor

4. A hand drying device that employs an air-knife system that delivers high-velocity, pressurized air at ambient temperatures.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-3040 Handwashing aids and devices, use restrictions

A sink used for food preparation or utensil washing, or a service sink or curbed cleaning facility used for the disposal of mop water or similar wastes, shall not be provided with the handwashing aids and devices required for a handwashing sink as specified under 12VAC5-421-3020 , 12VAC5-421-3030, and 12VAC5-421-2650 C.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3045 Handwashing signage

A sign or poster that notifies food employees to wash their hands shall be provided at all handwashing sinks used by food employees and shall be clearly visible to food employees.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 26, Issue 7, eff. January 1, 2010.

12VAC5-421-3050 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 26, Issue 7, eff. January 1, 2010.

12VAC5-421-3060 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; repealed, Virginia Register Volume 26, Issue 7, eff. January 1, 2010.

12VAC5-421-3070 Toilet tissue, availability

A supply of toilet tissue shall be available at each toilet.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-3080 Lighting, intensity

The light intensity shall be:

1. At least 10 foot candles (108 lux) at a distance of 30 inches (75 cm) above the floor, in walk-in refrigeration units and dry food storage areas and in other areas and rooms during periods of cleaning;

2. At least 20 foot candles (215 lux):

a. At a surface where food is provided for consumer self-service such as buffets and salad bars or where fresh produce or packaged foods are sold or offered for consumption;

b. Inside equipment such as reach-in and under-counter refrigerators;

c. At a distance of 30 inches (75 cm) above the floor in areas used for handwashing, warewashing, and equipment and utensil storage, and in toilet rooms; and

3. At least 50 foot candles (540 lux) at a surface where a food employee is working with food or working with utensils or equipment such as knives, slicers, grinders, or saws where employee safety is a factor.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 26, Issue 7, eff. January 1, 2010.

12VAC5-421-3090 Ventilation, mechanical

If necessary to keep rooms free of excessive heat, steam, condensation, vapors, obnoxious odors, smoke, and fumes, mechanical ventilation of sufficient capacity shall be provided.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-3100 Dressing areas and lockers, designation

A. Dressing rooms or dressing areas shall be designated if employees routinely change their clothes in the establishment.

B. Lockers or other suitable facilities shall be provided for the orderly storage of employees' clothing and other possessions.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-3110 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; repealed, Virginia Register Volume 26, Issue 7, eff. January 1, 2010.

12VAC5-421-3120 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; repealed, Volume 26, Issue 7, eff. January 1, 2010.

Article 4 Location and Placement

12VAC5-421-3130 Toilet rooms, convenience and accessibility

Toilet rooms shall be conveniently located and accessible to employees during all hours of operation. Toilet rooms intended for use by customers shall not necessitate travel through food preparation or handling areas.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-3140 Employee accommodations, designated areas

A. Areas designated for employees to eat, drink, and use tobacco products shall be located so that food, equipment, linens, and single-service and single-use articles are protected from contamination.

B. Lockers or other suitable facilities shall be located in a designated room or area where contamination of food, equipment, utensils, linens, and single-service and single-use articles can not occur.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-3150 Distressed merchandise, segregation and location

Products that are held by the permit holder for credit, redemption, or return to the distributor, such as damaged, spoiled, or recalled products, shall be segregated and held in designated areas that are separated from food, equipment, utensils, linens, and single-service and single-use articles.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-3160 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; repealed, Virginia Register Volume 26, Issue 7, eff. January 1, 2010.

Article 5 Maintenance and Operation

12VAC5-421-3170 Repairing

The physical facilities shall be maintained in good repair.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-3180 Cleaning, frequency and restrictions

A. The physical facilities shall be cleaned as often as necessary to keep them clean.

B. Except for cleaning that is necessary due to a spill or other accident, cleaning shall be done during periods when the least amount of food is exposed such as after closing.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 26, Issue 7, eff. January 1, 2010.

12VAC5-421-3190 Cleaning floors, dustless methods

A. Except as specified in subsection B of this section, only dustless methods of cleaning shall be used, such as wet cleaning, vacuum cleaning, mopping with treated dust mops, or sweeping using a broom and dust-arresting compounds.

B. Spills or drippage on floors that occur between normal floor cleaning times may be cleaned:

1. Without the use of dust-arresting compounds; and

2. In the case of liquid spills or drippage, with the use of a small amount of absorbent compound such as sawdust or diatomaceous earth applied immediately before spot cleaning.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-3200 Cleaning ventilation systems, nuisance and discharge prohibition

A. Intake and exhaust air ducts shall be cleaned and filters changed so they are not a source of contamination by dust, dirt, and other materials.

B. If vented to the outside, ventilation systems shall not create a public health hazard or nuisance or unlawful discharge.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007.

12VAC5-421-3210 Cleaning maintenance tools, preventing contamination

Food preparation sinks, handwashing lavatories, and warewashing equipment shall not be used for the cleaning of maintenance tools, the preparation or holding of maintenance materials, or the disposal of mop water and similar liquid wastes.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-3220 Drying mops

After use, mops shall be placed in a position that allows them to air-dry without soiling walls, equipment, or supplies.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-3230 Absorbent materials on floors, use limitation

Except as specified in 12VAC5-421-3190 B, sawdust, wood shavings, granular salt, baked clay, diatomaceous earth, or similar materials shall not be used on floors.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007.

12VAC5-421-3240 Cleaning of plumbing fixtures

Plumbing fixtures such as handwashing sinks, toilets, and urinals shall be cleaned as often as necessary to keep them clean and maintained and used as specified under 12VAC5-421-2310.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 26, Issue 7, eff. January 1, 2010.

12VAC5-421-3250 Closing toilet room doors

Toilet room doors as specified under 12VAC5-421-2920 shall be kept closed except during cleaning and maintenance operations unless otherwise required by other regulations or law.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-3260 Using dressing rooms and lockers

A. Dressing rooms shall be used by employees if the employees regularly change their clothes in the establishment.

B. Lockers or other suitable facilities shall be used for the orderly storage of employee clothing and other possessions.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-3270 Controlling pests

The presence of insects, rodents, and other pests shall be controlled to minimize their presence on the premises by:

1. Routinely inspecting incoming shipments of food and supplies;

2. Routinely inspecting the premises for evidence of pests;

3. Using methods, if pests are found, such as trapping devices or other means of pest control as specified under 12VAC5-421-3360, 12VAC5-421-3440, and 12VAC5-421-3450;^Pf and

4. Eliminating harborage conditions.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-3280 Removing dead or trapped birds, insects, rodents, and other pests

Dead or trapped birds, insects, rodents, and other pests shall be removed from control devices and the premises at a frequency that prevents their accumulation, decomposition, or the attraction of pests.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-3290 Storing maintenance tools

Maintenance tools such as brooms, mops, vacuum cleaners, and similar items shall be:

1. Stored so they do not contaminate food, equipment, utensils, linens, and single-service and single-use articles; and

2. Stored in an orderly manner that facilitates cleaning the area used for storing the maintenance tools.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-3300 Maintaining premises, unnecessary items and litter

The premises shall be free of:

1. Items that are unnecessary to the operation or maintenance of the establishment such as equipment that is nonfunctional or no longer used; and

2. Litter.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-3310 Prohibiting animals

A. Except as specified in subsections B and C of this section, live animals shall not be allowed on the premises of a food establishment.^Pf

B. Live animals may be allowed in the following situations if the contamination of food; clean equipment, utensils, and linens; and unwrapped single-service and single-use articles cannot result:

1. Edible fish or decorative fish in aquariums, shellfish or crustacea on ice or under refrigeration, and shellfish and crustacea in display tank systems;

2. Patrol dogs accompanying police or security officers in offices and dining, sales, and storage areas, and sentry dogs running loose in outside fenced areas;

3. In areas that are not used for food preparation and that are usually open for customers, such as dining and sales areas, service animals that are controlled by the disabled employee or person if a health or safety hazard will not result from the presence or activities of the service animal;

4. Pets in the common dining areas of institutional care facilities such as nursing homes, assisted living facilities, group homes, residential care facilities, and bed and breakfast operations at times other than during meals if:

a. Effective partitioning and self-closing doors separate the common dining areas from food storage or food preparation areas;

b. Condiments, equipment, and utensils are stored in enclosed cabinets or removed from the common dining areas when pets are present; and

c. Dining areas including tables, countertops, and similar surfaces are effectively cleaned before the next meal service;

5. In areas that are not used for food preparation, storage, sales, display, or dining, in which there are caged animals or animals that are similarly restricted, such as in a variety store that sells pets or a tourist park that displays animals; and

6. Dogs in outdoor dining areas if:

a. The outdoor dining area is not fully enclosed with floor to ceiling walls and is not considered a part of the interior physical facility;

b. The outdoor dining area is equipped with an entrance that is separate from the main entrance to the food establishment and the separate entrance serves as the sole means of entry for patrons accompanied by dogs;

c. A sign stating that dogs are allowed in the outdoor dining area is posted at each entrance to the outdoor dining area in such a manner as to be clearly observable by the public;

d. A sign within the outdoor dining area stating the requirements as specified in subdivisions 6 e, 6 f, and 6 g of this subsection is provided in such a manner as to be clearly observable by the public;

e. Food and water provided to dogs is served using equipment that is not used for service of food to persons or is served in single-use articles;

f. Dogs are not allowed on chairs, seats, benches, or tables;

g. Dogs are kept on a leash or within a pet carrier and under the control of an adult at all times; and

h. Establishment provides effective means for cleaning up dog vomitus and fecal matter.

C. Live or dead fish bait may be stored if contamination of food; clean equipment, utensils, and linens; and unwrapped single-service and single-use articles cannot result.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016; Volume 35, Issue 1, eff. October 3, 2018; Volume 37, Issue 18, eff. June 10, 2021.

Article 1 Labeling and Identification

12VAC5-421-3320 Original containers - identifying information, prominence

Containers of poisonous or toxic materials and personal care items shall bear a legible manufacturer's label.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-3330 Working containers - common name

Working containers used for storing poisonous or toxic materials such as cleaners and sanitizers taken from bulk supplies shall be clearly and individually identified with the common name of the material.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

Article 2 Operational Supplies and Applications

12VAC5-421-3340 Storage, separation

Poisonous or toxic materials shall be stored so they cannot contaminate food, equipment, utensils, linens, and single-service and single-use articles by:

1. Separating the poisonous or toxic materials by spacing or partitioning;^P and

2. Locating the poisonous or toxic materials in an area that is not above food, equipment, utensils, linens, and single-service or single-use articles. This subsection does not apply to equipment and utensil cleaners and sanitizers that are stored in warewashing areas for availability and convenience if the materials are stored to prevent contamination of food, equipment, utensils, linens, and single-service and single-use articles.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-3350 Presence and use restriction

A. Only those poisonous or toxic materials that are required for the operation and maintenance of a food establishment, such as for the cleaning and sanitizing of equipment and utensils and the control of insects and rodents, shall be allowed in a food establishment.^Pf

B. Subsection A of this section does not apply to packaged poisonous or toxic materials that are for retail sale.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-3360 Conditions of use

Poisonous or toxic materials shall be:

1. Used according to:

a. Law and this chapter;

b. Manufacturer's use directions included in labeling, and, for a pesticide, manufacturer's label instructions that state that use is allowed in a food establishment;^P

c. The conditions of certification, if certification is required, for use of the pest control materials;^P and

d. Additional conditions that may be established by the department; and

2. Applied so that:

a. A hazard to employees or other persons is not constituted;^P and

b. Contamination including toxic residues due to drip, drain, fog, splash, or spray on food, equipment, utensils, linens, and single-service and single-use articles is prevented, and is achieved by:^P

(1) Removing the items;^P

(2) Covering the items with impermeable covers;^P or

(3) Taking other appropriate preventive actions;^P and

(4) Cleaning and sanitizing equipment and utensils after the application.^P

3. A restricted use pesticide shall be applied only by an applicator certified as defined in 7 USC § 136(e) (Federal Insecticide, Fungicide and Rodenticide Act), or a person under the direct supervision of a certified applicator.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021; Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-3370 Poisonous or toxic material containers

A container previously used to store poisonous or toxic materials may not be used to store, transport, or dispense food, equipment, utensils, linens, single-service, or single-use articles.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016; Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-3380 Sanitizers, criteria

Chemical sanitizers, including chemical sanitizing solutions generated on site, and other chemical antimicrobials applied to food-contact surfaces shall:

1. Meet the requirements specified in 40 CFR 180.940,^P or

2. Meet the requirements as specified in 40 CFR 180.2020.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-3390 Chemicals for washing, treatment, storage, and processing fruits and vegetables, criteria

Chemicals, including those generated on site, used to wash or peel raw, whole fruits and vegetables or used in the treatment, storage, and processing of fruits and vegetables shall:

1. Be an approved food additive listed for this intended use in 21 CFR Part 173;^Por

2. Be generally recognized as safe (GRAS) for this intended use;^Por

3. Be the subject of an effective food contact notification for this intended use (only effective for the manufacturer or supplier identified in the notification);^P and

4. Meet the requirements in 40 CFR Part 156.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3400 Boiler water additives, criteria

Chemicals used as boiler water additives shall meet the requirements specified in 21 CFR 173.310.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-3410 Drying agents, criteria

Drying agents used in conjunction with sanitization shall:

1. Contain only components that are listed as one of the following:

a. Generally recognized as safe (GRAS) for use in food as specified in 21 CFR Part 182 or 21 CFR Part 184,^P

b. GRAS for the intended use as specified in 21 CFR Part 186,^P

c. GRAS for the intended use as determined by experts qualified in scientific training and experience to evaluate the safety of substances added, directly or indirectly, to food as described in 21 CFR 170.30, ^P

d. Subject of an effective Food Contact Notification as described in the Federal Food Drug and Cosmetic Act (FFDCA) § 409(h),^P

e. Approved for use as a drying agent under a prior sanction specified in 21 CFR Part 181 as specified in the Federal Food Drug and Cosmetic Act (FFDCA) § 201(s)(4),^P

f. Specifically regulated as an indirect food additive for use as a drying agent as specified in 21 CFR Parts 174 through 178,^P or

g. Approved for use as a drying agent under the threshold of regulation process established by 21 CFR 170.39;^P and

2. When sanitization is with chemicals, the approval required under subdivision 1 e or g of this section or the regulation as an indirect food additive required under subdivision 1 f of this section, shall be specifically for use with chemical sanitizing solutions.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3420 Lubricants - incidental food contact, criteria

Lubricants shall meet the requirements specified in 21 CFR 178.3570 if they are used on food-contact surfaces, on bearings and gears located on or within food-contact surfaces, or on bearings and gears that are located so that lubricants may leak, drip, or be forced into food or onto food-contact surfaces.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-3430 Restricted use pesticides, criteria

Restricted use pesticides specified under subdivision 3 of 12VAC5-421-3360 shall meet the requirements specified in 40 CFR Part 152, Subpart I.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-3440 Rodent bait stations

Rodent bait shall be contained in a covered, tamper-resistant bait station.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-3450 Tracking powders, pest control, and monitoring

A. Except as specified in subsection B of this section, a tracking powder pesticide shall not be used in a food establishment.^P

B. If used, a nontoxic tracking powder such as talcum or flour shall not contaminate food, equipment, utensils, linens, and single-service and single-use articles.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-3460 Medicines - restriction and storage

A. No food establishment may display medicines other than medicines for retail sale.^Pf

B. No food establishment may store medicines other than the following:

1. Medicines for the use of children in a day care center;^P

2. Medicines that are referenced in § 8.01-225 A 17 of the Code of Virginia;^P and

3. Medicines that are necessary for the health of employees.^P

C. Medicines that are stored or displayed in a food establishment shall be labeled as specified under 12VAC5-421-3320 and located to prevent the contamination of food, equipment, utensils, linens, and single-service and single-use articles.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016; Volume 41, Issue 22, eff. July 31, 2025.

12VAC5-421-3470 Refrigerated medicines, storage

Medicines belonging to employees or to children in a day care center that require refrigeration and are stored in a food refrigerator shall be:

1. Stored in a package or container and kept inside a covered, leakproof container that is identified as a container for the storage of medicines;^P and

2. Located so they are inaccessible to children.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-3480 First aid supplies, storage

First aid supplies that are in a food establishment for the employees' use shall be:

1. Labeled as specified under 12VAC5-421-3320;^Pf and

2. Stored in a kit or a container that is located to prevent the contamination of food, equipment, utensils, and linens, and single-service and single-use articles.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-3490 Other personal care items, storage

Except as specified under 12VAC5-421-3470 and 12VAC5-421-3480, employees shall store their personal care items in facilities as specified under 12VAC5-421-3100 B.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

Article 3 Stock and Retail Sale

12VAC5-421-3500 Storage and display, separation

Poisonous or toxic materials shall be stored and displayed for retail sale so they cannot contaminate food, equipment, utensils, linens, and single-service and single-use articles by:

1. Separating the poisonous or toxic materials by spacing or partitioning;^P and

2. Locating the poisonous or toxic materials in an area that is not above food, equipment, utensils, linens, and single-service or single-use articles.^P

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

Article 1 Applicability of Chapter

12VAC5-421-3510 Public health protection

A. The department shall apply this chapter to promote its underlying purpose, as specified in 12VAC5-421-30, of safeguarding public health and ensuring that food is safe, unadulterated, and honestly presented when offered to the consumer or donated.

B. In enforcing the provisions of this chapter, the department shall assess existing facilities or equipment that were in use before June 10, 2021, based on the following considerations:

1. Whether the facilities or equipment are in good repair and capable of being maintained in a sanitary condition;

2. Whether food-contact surfaces comply with 12VAC5-421-960 through 12VAC5-421-1060; and

3. Whether the capacities of cooling, heating, and holding equipment are sufficient to comply with 12VAC5-421-1450.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 37, Issue 18, eff. June 10, 2021; Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-3520 Preventing health hazards, provision for conditions not addressed

A. If necessary to protect against public health hazards or nuisances, the department may impose specific requirements in addition to the requirements contained in this regulation that are authorized by law.

B. The department shall document the conditions that necessitate the imposition of additional requirements and the underlying public health rationale. The documentation shall be provided to the permit applicant or permit holder and a copy shall be maintained in the department's file for the food establishment.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3530 Application of Administrative Process Act

The provisions of the Virginia Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) shall govern the procedures for rendering all case decisions, as defined in § 2.2-4001, and for issuing all orders and regulations promulgated pursuant to the authority of Title 35.1.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-3540 [Reserved]. (Reserved)

12VAC5-421-3550 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; repealed, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3560 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 35, Issue 1, eff. October 3, 2018; repealed, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3570 Variances

A. The commissioner or his designee may grant a variance to this chapter by following the appropriate procedures set forth in this section and 12VAC5-421-3580.

B. The commissioner or the commissioner's designee may grant a variance if he finds that the hardship imposed, which may be economic, outweighs the benefits that may be received by the public and that granting such a variance does not subject the public to unreasonable health risks or environmental pollution.

C. Any owner or permit holder who seeks a variance shall apply in writing . The request shall be sent to the local health department. The application shall include:

1. A citation to the regulation from which a variance is requested;

2. The nature and duration of the variance requested;

3. Any relevant analytical results including result of relevant tests conducted pursuant to the requirements of these regulations;

4. Statements or evidence which establishes that the public health, welfare and environment would not be adversely affected if the variance were granted;

5. Suggested conditions that might be imposed on the granting of a variance that would limit the detrimental impact on the public health and welfare;

6. A HACCP plan if required as specified under 12VAC5-421-3620 A that includes the information specified under 12VAC5-421-3630 as it is relevant to the variance requested.

7. Other information believed pertinent by the applicant; and

8. Such other information as the district or local health department or commissioner may require.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3580 Evaluation of a variance application

A. The commissioner shall act on any variance request submitted pursuant to 12VAC5-421-3570 C within 60 days of receipt of the request.

B. In evaluating a variance application, the commissioner shall consider such factors as the following:

1. The effect that such a variance would have on the operation of the food establishment.

2. The cost and other economic considerations imposed by this requirement;

3. The effect that such a variance would have on protection of the public health, safety, welfare and the environment;

4. Such other factors as the commissioner, deputy commissioner, or director of the office of environmental health services may deem appropriate.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3590 Disposition of a variance request

A. If the commissioner proposes to deny the variance he shall provide the owner an opportunity to an informal fact-finding conference as provided in § 2.2-4019 of the Code of Virginia. Following this opportunity for an informal fact-finding conference the commissioner may reject any application for a variance by sending a rejection notice to the applicant. The rejection notice shall be in writing and shall state the reasons for the rejection.

B. If the commissioner proposes to grant a variance request submitted pursuant to this part, the applicant shall be notified in writing of this decision. Such notice shall identify the variance, the food establishment involved, and shall specify the period of time for which the variance will be effective. Such notice shall provide that the variance will be terminated when the food establishment comes into compliance with the applicable regulation and may be terminated upon a finding by the commissioner that the food establishment has failed to comply with any requirements or schedules issued in conjunction with the variance. The effective date of the variance shall be as noted in the variance letter.

C. All variances granted to any food establishment may not be transferable unless otherwise stated. Each variance shall be attached to the permit to operate and posted prominently in a conspicuous place for public view.

D. No owner or permit holder may challenge the terms or conditions of a variance after 30 calendar days have elapsed from the receipt of the variance.

E. Each variance is revoked when the permit to operate is revoked, suspended, or expired.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-3595 Conformance with approved procedures

If the commissioner or the commissioner's designee grants a variance pursuant to 12VAC5-421-3570 or a HACCP plan is otherwise required pursuant to 12VAC5-421-3620, the permit holder shall:

1. Maintain the approved variance at the food establishment;^Pf

2. Comply with the HACCP plans and procedures that are submitted pursuant to 12VAC5-421-3630 and approved as a basis for the variance;^P and

3. Maintain and, upon request, provide to the department records specified under subdivisions 5 and 6 c of 12VAC5-421-3630 that demonstrate that the following are routinely employed:

a. Procedures for monitoring the critical control points;^PF

b. Monitoring of the critical control points;^PF

c. Verification of the effectiveness of the operation or process;^PF and

d. Necessary corrective actions if there is failure at the critical control point.^PF

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 18, eff. June 10, 2021; amended, Virginia Register Volume 42, Issue 25, eff. September 10, 2026.

Article 2 Plan Submission and Approval

12VAC5-421-3600 Facility and operating plans

A permit applicant or permit holder shall submit to the department properly prepared plans and specifications for review and approval before:

1. The construction of a food establishment;^Pf

2. The conversion of an existing structure for use as a food establishment;^Pf or

3. The remodeling of a food establishment or a change of type of food establishment or food operation as specified under subdivision 3 of 12VAC5-421-3700 if the department determines that plans and specifications are necessary to ensure compliance with this chapter.^Pf

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3610 Contents of the plans and specifications

The plans and specifications for a food establishment, including a food establishment specified under 12VAC5-421-3620, shall include, as required by the department based on the type of operation, type of food preparation, and foods prepared, the following information to demonstrate conformance with the provisions of this chapter:

1. Intended menu;

2. Anticipated volume of food to be stored, prepared, and sold or served;

3. Proposed layout, mechanical schematics, construction materials, and finish schedules;

4. Proposed equipment types, manufacturers, model numbers, locations, dimensions, performance capacities, and installation specifications;

5. Evidence that standard procedures ensuring compliance with the requirements of this chapter are developed or are being developed; and

6. Other information that may be required by the department for the proper review of the proposed construction, conversion or modification, and procedures for operating a food establishment.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3620 When a HACCP plan is required

A. Before engaging in an activity that requires a HACCP plan, a permit applicant or permit holder shall submit to the department for approval a properly prepared HACCP plan as specified under 12VAC5-421-3630 and the relevant provisions of this chapter if:

1. Submission of a HACCP plan is required according to law;

2. A variance is required as specified under 12VAC5-421-700 D 4,12VAC5-421-860, or 12VAC5-421-1300 B; or

3. The department determines that a food preparation or processing method requires a variance based on a plan submittal specified under 12VAC5-421-3610, an inspectional finding, or a variance request.

B. Before engaging in reduced oxygen packaging without a variance as specified under 12VAC5-421-870, a permit applicant or permit holder shall submit a properly prepared HACCP plan to the department.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3630 Contents of a HACCP plan

For a food establishment that is required to have a HACCP plan pursuant to 12VAC5-421-3620, the permit applicant or permit holder shall submit to the department a properly prepared HACCP plan that includes:

1. General information, including the name of the permit applicant or permit holder, the food establishment address, and contact information;

2. A categorization of the types of time/temperature control for safety food that is to be controlled under the HACCP plan;^Pf

3. A flow diagram or chart for each specific food or category type that identifies:

a. Each step in the process,^Pf and

b. The steps that are critical control points^Pf

.

4. The ingredients, recipes or formulations, materials and equipment used in the preparation of each specific food or category type, and the methods and procedural control measures that address the food safety concerns involved;^Pf

5. A critical control points summary for each specific food or category type that clearly identifies:

a. Each critical control point;^Pf

b. The significant hazards for each critical control point;^Pf

c. The critical limits for each critical control point;^Pf

d. The method and frequency for monitoring and controlling each critical control point by the designated food employee or the person in charge;^Pf

e. The method and frequency for the person in charge or food employee to routinely verify that the food employee is following standard operating procedures and monitoring critical control points;^Pf

f. The action to be taken by the food employee or person in charge if the critical limits for each critical control point are not met;^Pfand

g. Records to be maintained by the person in charge to demonstrate that the HACCP plan is properly operated and managed;^Pf

6. Supporting documents, including:

a. Food employee and supervisory training plan addressing food safety issues;^Pf

b. Copies of blank records forms that are necessary to implement the HACCP plan;^Pf

c. Additional scientific data or other information, as required by the department, supporting the determination that food safety is not compromised by the proposal;^Pf and

7. Any other information required by the department.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021; Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-3640 Confidentiality -- trade secrets

The department shall treat as confidential in accordance with law, information that meets the criteria specified in law for a trade secret and is contained on inspection report forms and in the plans and specifications submitted as specified under 12VAC5-421-3610 and 12VAC5-421-3630.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3650 Preoperational inspections

The department shall conduct one or more preoperational inspections to verify that the food establishment is constructed and equipped in accordance with the approved plans and approved modifications of those plans, has established standard operating procedures as specified under subdivision 5 of 12VAC5-421-3610 and is in compliance with law and this chapter.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

Article 3 Permit to Operate

12VAC5-421-3660 Permits

A. No person shall own, establish, conduct, maintain, manage, or operate any food establishment in this Commonwealth unless the food establishment is permitted as provided in this section. All permits shall be in the name of the owner . Permits shall not be issued to newly constructed or extensively remodeled food establishments until a certificate of occupancy has been issued by the Building Official. Only a person who complies with the requirements of this part shall be entitled to receive or retain such a permit.

B. Permits issued shall not be transferable from one person to another or from one location to another. A new owner shall be required to make a written application for a permit. The application forms are obtainable at all local health departments.

C. Any person operating a food establishment with a valid permit who desires to expand or modify the establishment, shall notify the local health department in the jurisdiction where the food establishment is located, and the local health department shall determine whether such expansion, modification, or reclassification is in compliance with the applicable sections of this chapter.

D. The permit shall be posted in every food establishment in a place where it is readily observable by the public transacting business with the establishment.

E. Permits shall expire annually otherwise not to exceed 12 months from the date of issuance.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3670 Application procedure, submission before proposed opening

A. An applicant seeking to operate a nontemporary food establishment shall submit an application for a permit at least 30 calendar days before the date planned for opening a food establishment or at least 30 calendar days before the expiration date of the current permit for an existing facility.

B. An applicant seeking to operate a temporary food establishment shall submit an application for a permit at least 10 calendar days before the date planned for opening the temporary food establishment.

C. Any applicant who fails to complete the application process within 12 months of receipt of the application by the local health department's office may be required to submit a new application and plan.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3680 Form of submission

A person desiring to operate a food establishment shall submit to the department a written application for a permit on a form provided by the department.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3690 Qualifications and responsibilities of applicants

To qualify for a permit, an applicant shall:

1. Be an owner of the food establishment or an officer of the legal ownership;

2. Comply with the requirements of this chapter; and

3. As specified under 12VAC5-421-3820, agree to allow access to the food establishment and to provide required information.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3700 Contents of the application

The application shall include:

1. The name, mailing address, telephone number, and signature of the person applying for the permit and the name, mailing address, and location of the food establishment;

2. Information specifying whether the food establishment is owned by an association, corporation, individual, partnership, or other legal entity;

3. A statement specifying whether the food establishment:

a. Is mobile or stationary, and temporary or permanent; and

b. Is an operation that includes one or more of the following:

(1) Prepares, offers for sale, or serves time/temperature control for safety food:

(a) Only to order upon a consumer's request;

(b) In advance in quantities based on projected consumer demand and discards food that is not sold or served at an approved frequency; or

(c) Using time as the public health control as specified under 12VAC5-421-850;

(2) Prepares time/temperature control for safety food in advance using a food preparation method that involves two or more steps which may include combining time/temperature control for safety food ingredients; cooking; cooling; reheating; hot or cold holding; freezing; or thawing;

(3) Prepares food as specified under subdivision 3 b (2) of this section for delivery to and consumption at a location off the premises of the food establishment where it is prepared;

(4) Prepares food as specified under subdivision 3 b (2) of this section for service to a highly susceptible population;

(5) Prepares only food that is not time/temperature control for safety food; or

(6) Does not prepare, but offers for sale only prepackaged food that is not time/temperature control for safety food;

4. The name, title, address, and telephone number of the person directly responsible for the food establishment;

5. The name, title, address, and telephone number of the person who functions as the immediate supervisor of the person specified under subdivision 4 of this section such as the zone, district, or regional supervisor;

6. The names, titles, and addresses of:

a. The persons comprising the legal ownership as specified under subdivision 2 of this section, including the owners and officers; and

b. The local resident agent if one is required based on the type of legal ownership;

7. A statement signed by the applicant that:

a. Attests to the accuracy of the information provided in the application; and

b. Affirms that the applicant will:

(1) Comply with this chapter; and

(2) Allow the department access to the establishment as specified under 12VAC5-421-3820 and to the records specified under 12VAC5-421-440 and 12VAC5-421-2330 and subdivision 5 of 12VAC5-421-3630; and

8. Other information required by the department.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021; Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-3710 New, converted, or remodeled establishments

For food establishments that are required to submit plans as specified under 12VAC5-421-3600 the department shall issue a permit to the applicant after:

1. A properly completed application is submitted;

2. Any required fee is submitted;

3. The required plans, specifications, and information are reviewed and approved; and

4. A preoperational inspection as specified in 12VAC5-421-3650 shows that the establishment is built or remodeled in accordance with the approved plans and specifications and that the establishment is in compliance with this chapter.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3720 Existing establishments, permit renewal, change of ownership, or termination

A. The department may renew a permit for an existing food establishment or may issue a permit to a new owner of an existing food establishment after a properly completed application is submitted, reviewed, and approved, any fees are paid, and an inspection shows that the establishment is in compliance with this chapter.

B. An existing food establishment shall notify the department in writing of a change of legal ownership or when business operations have terminated. Such notice shall be submitted in writing to the department at least 30 days prior to the legal ownership transfer or termination of business operation.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3730 Denial of application for permit, notice

If an application for a permit to operate is denied, the department shall provide the applicant with a notice that includes:

1. The specific reasons and chapter citations for the permit denial;

2. The actions, if any, that the applicant must take to qualify for a permit; and

3. Advisement of the applicant's right of appeal and the process and time frames for appeal that are provided in law.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3740 Responsibilities of the department

A. At the time a permit is first issued, the department shall provide to the permit holder a copy (or opportunity to obtain a copy) of this chapter so that the permit holder is notified of the compliance requirements and the conditions of retention, as specified under 12VAC5-421-3750, that are applicable to the permit.

B. Failure to provide the information specified in subsection A of this section does not prevent the department from taking authorized action or seeking remedies if the permit holder fails to comply with this chapter or an order, warning, or directive of the department.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3750 Responsibilities of the permit holder

In order to retain a permit issued by the department, the permit holder shall:

1. Post the permit in a location in the food establishment that is conspicuous to consumers;

2. Comply with the provisions of this chapter including the conditions of a granted variance as specified under 12VAC5-421-3590 and 12VAC5-421-3595, and approved plans as specified under 12VAC5-421-3610;

3. If a food establishment is required under 12VAC5-421-3620 to operate under a HACCP plan, comply with the plan as specified under 12VAC5-421-3595;

4. Immediately contact the department to report an illness of a food employee or conditional employee as specified under 12VAC5-421-80 B;

5. Immediately discontinue operations and notify the department if an imminent health hazard may exist as specified under 12VAC5-421-3910;

6. Allow representatives of the department access to the food establishment as specified under 12VAC5-421-3820;

7. Replace existing facilities and equipment specified in 12VAC5-421-3510 with facilities and equipment that comply with this chapter if:

a. The department directs the replacement because the facilities and equipment constitute a public health hazard or nuisance or no longer comply with the criteria upon which the facilities and equipment were accepted;

b. The department directs the replacement of the facilities and equipment because of a change of ownership; or

c. The facilities and equipment are replaced in the normal course of operation;

8. Comply with directives of the department including time frames for corrective actions specified in inspection reports, notices, orders, warnings, and other directives issued by the department in regard to the permit holder's food establishment or in response to community emergencies;

9. Accept notices issued and served by the department according to law; and

10. Be subject to the administrative, civil, injunctive, and criminal remedies authorized in law for failure to comply with this chapter or a directive of the department, including time frames for corrective actions specified in inspection reports, notices, orders, warnings, and other directives.

11. Notify customers that a copy of the most recent establishment inspection report is available upon request by:

a. Posting a sign or placard in a location in the food establishment that is conspicuous to customers; or

b. By another method acceptable to the department.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3760 Permits not transferable

A permit shall not be transferred from one person to another person, from one food establishment to another, or from one type of operation to another if the food operation changes from the type of operation specified in the application as specified under 12VAC5-421-3700 and the change in operation is not approved.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007.

12VAC5-421-3770 Summary suspension of a permit

The director may summarily suspend a permit to operate a food establishment if the director finds the continued operation constitutes a substantial and imminent threat to the public health. Upon receipt of such notice that a permit is suspended, the permit holder shall cease food operations immediately and begin corrective action.

Whenever a permit is suspended, the holder of the permit or the person in charge shall be notified in writing by mail or by hand delivery. Upon receipt of notice that the permit is immediately suspended, the former permit holder shall be given an opportunity for an informal fact-finding conference in accordance with § 2.2-4019 of the Code of Virginia. The request for an informal fact-finding conference shall be in writing. The written request shall be filed with the local department by the former holder of the permit. If written request for an informal fact-finding conference is not filed within 10 working days, the suspension is sustained. Each holder of a suspended permit shall be afforded an opportunity for an informal fact-finding conference, within three working days of receipt of a request for the informal fact-finding conference. The director may end the suspension at any time if the reasons for the suspension no longer exist.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3780 Revocation of a permit

The director may, after conducting an informal fact-finding conference in accordance with § 2.2-4019 of the Code of Virginia, revoke a permit for violation of any of the requirements of this part.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3790 Application after revocation

Any person whose permit has been revoked, may apply for a new permit by following the procedures of this part outlined in 12VAC5-421-3670 through 12VAC5-421-3700.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

Article 4 Inspection and Correction of Violations

12VAC5-421-3800 Periodic inspection

Food establishments shall be inspected by the department. Inspections of the food establishments shall be performed as often as necessary for the enforcement of this chapter in accordance with the following:

1. Except as specified in subdivisions 2 and 3 of this section, the department shall inspect a food establishment at least once every six months.

2. The department may increase the interval between inspections beyond six months if:

a. The food establishment is fully operating under an approved and validated HACCP plan as specified under 12VAC5-421-3595 and 12VAC5-421-3630;

b. The food establishment is assigned a less frequent inspection frequency based on an established risk-based inspection schedule uniformly applied throughout the Commonwealth and updated annually upon reissuance of the annual permit; or

c. The establishment's operation involves only coffee service and other unpackaged or prepackaged food that is not time/temperature control for safety food, such as carbonated beverages and snack food such as chips, nuts, popcorn, and pretzels.

3. The department shall inspect a temporary food establishment during its permit period, unless the department develops a written risk-based plan for adjusting the frequency of inspections of temporary food establishments that is uniformly applied throughout the Commonwealth.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3810 Performance-based and risk-based inspections

Within the parameters specified in 12VAC5-421-3800, the department shall prioritize the conducting of more frequent inspections based upon its assessment of a food establishment's history of compliance with this chapter and the establishment's potential as a vector of foodborne illness by evaluating:

1. Past performance for nonconformance with this chapter or HACCP plan requirements that are priority items or priority foundation items;

2. Past performance for numerous or repeat violations of this chapter or HACCP plan requirements that are core items;

3. Past performance for complaints investigated and found to be valid;

4. The hazards associated with the particular foods that are prepared, stored, or served;

5. The type of operation including the methods and extent of food storage, preparation, and service;

6. The number of people served; and

7. Whether the population served is a highly susceptible population.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3815 Competency of environmental health specialists

A. An authorized representative of the commissioner who inspects a food establishment or conducts plan review for compliance with this chapter shall have the knowledge, skills, and ability to adequately perform the required duties. For the purposes of this section, competency shall be demonstrated when an environmental health specialist meets the training and standardization requirements as determined by the department.

B. The department shall ensure that authorized representatives who inspect a food establishment or conduct plan review for compliance with this chapter have access to training and continuing education as needed to properly identify violations and apply this chapter.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 2, eff. October 16, 2007; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3820 Access allowed at reasonable times after due notice

After the department presents official credentials and provides notice of the purpose of and an intent to conduct an inspection, the person in charge shall allow the department to determine if the food establishment is in compliance with this chapter by allowing access to the establishment, allowing inspection, and providing information and records specified in this chapter and to which the department is entitled according to law, during the food establishment's hours of operation and other reasonable times.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3830 Refusal, notification of right to access, and final request for access

If a person denies access to the department, the department shall:

1. Inform the person that:

a. The permit holder is required to allow access to the department as specified under 12VAC5-421-3820,

b. Access is a condition of the acceptance and retention of a food establishment permit to operate as specified under subdivision 6 of 12VAC5-421-3750 , and

c. If access is denied, the commissioner or his designee may apply to an appropriate circuit court for an inspection warrant authorizing such inspection, testing, or taking samples for testing as provided in Chapter 24 (§ 19.2-393 et seq.) of Title 19.2 of the Code of Virginia; and

2. Make a final request for access.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3840 Refusal, reporting

If after the department presents credentials and provides notice as specified under 12VAC5-421-3820, explains the authority upon which access is requested, and makes a final request for access as specified in 12VAC5-421-3830, the person in charge continues to refuse access, the department shall provide details of the denial of access on an inspection report form.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3850 Inspection warrants

If denied access to a food establishment for an authorized purpose and after complying with 12VAC5-421-3830, the commissioner or his designee may apply to an appropriate circuit court for an inspection warrant authorizing such inspection, testing, or taking samples for testing as provided in Chapter 24 (§ 19.2-393 et seq.) of Title 19.2 of the Code of Virginia.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-3860 Documenting information and observations

The department shall document on an inspection report form:

1. Administrative information about the food establishment's legal identity, street and mailing addresses, type of establishment and operation as specified under 12VAC5-421-3700, inspection date, and other information such as type of water supply and sewage disposal, status of the permit, and personnel certificates that may be required; and

2. Specific factual observations of violative conditions or other deviations from this chapter that require correction by the permit holder including:

a. Failure of the person in charge to demonstrate the knowledge of foodborne illness prevention, application of HACCP principles, and the requirements of this chapter specified under 12VAC5-421-60;

b. Failure of food employees, conditional employees, and the person in charge to report a disease or medical condition as specified under 12VAC5-421-80 B and D;

c. Nonconformance with priority, priority foundation, or core items of this chapter;

d. Failure of the appropriate food employees to demonstrate their knowledge of, and ability to perform in accordance with, the procedural, monitoring, verification, and corrective action practices required by the department as specified under 12VAC5-421-60;

e. Failure of the person in charge to provide records required by the department for determining conformance with a HACCP plan as specified under subdivision 5 g of 12VAC5-421-3630; and

f. Nonconformance with critical limits of a HACCP plan.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021; Volume 42, Issue 25, eff. September 10, 2026.

12VAC5-421-3870 Specifying time frame for corrections

The department shall specify on the inspection report form the time frame for correction of the violations as specified under 12VAC5-421-3910, 12VAC5-421-3930, and 12VAC5-421-3950.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3880 Issuing report and obtaining acknowledgment of receipt

At the conclusion of the inspection and according to law, the department shall provide a copy of the completed inspection report and the notice to correct violations to the permit holder or to the person in charge, and request a signed acknowledgment of receipt.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3890 Refusal to sign acknowledgment

The department shall:

1. Inform a person who declines to sign an acknowledgment of receipt of inspectional findings as specified in 12VAC5-421-3880 that:

a. An acknowledgment of receipt is not an agreement with findings,

b. Refusal to sign an acknowledgment of receipt will not affect the permit holder's obligation to correct the violations noted in the inspection report within the time frames specified, and

c. A refusal to sign an acknowledgment of receipt is noted in the inspection report and conveyed to the department's historical record for the food establishment; and

2. Make a final request that the person in charge sign an acknowledgment receipt of inspectional findings.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3900 Public records

Except as specified in 12VAC5-421-3640, the department shall treat the inspection report as a public record and shall make it available for disclosure to a person who requests it as provided in law.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3910 Imminent health hazard, ceasing operations and reporting

A. Except as specified in subsections B and C of this section, a permit holder shall immediately discontinue operations and notify the department if an imminent health hazard may exist because of an emergency such as a fire, flood, extended interruption of electrical or water service, sewage backup, misuse of poisonous or toxic materials, onset of an apparent foodborne illness outbreak, gross insanitary occurrence or condition, or other circumstance that may endanger public health.^P

B. A permit holder need not discontinue operations in an area of an establishment that is unaffected by the imminent health hazard.

C. Considering the nature of the potential hazard involved and the complexity of the corrective action needed, the department may agree to continuing operations in the event of an extended interruption of electrical or water service if:

1. A written emergency operating plan has been approved by the department;

2. Immediate corrective action is taken to eliminate, prevent, or control any food safety risk and imminent health hazard associated with the electrical or water service interruption; and

3. The department is informed upon implementation of the written emergency operating plan.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3920 Resumption of operations

If operations are discontinued as specified under 12VAC5-421-3910 or otherwise according to law, the permit holder shall obtain approval from the department before resuming operations.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3930 Timely correction

A. Except as specified in subsection B of this section, a permit holder shall at the time of inspection correct a priority item or priority foundation item in this chapter and implement corrective actions for a HACCP plan provision that is not in compliance with its critical limit.^Pf

B. Considering the nature of the potential hazard involved and the complexity of the corrective action needed, the department may agree to or specify a longer timeframe, not to exceed:

1. 72 hours after the inspection for the permit holder to correct priority items; or

2. 10 calendar days after the inspection for the permit holder to correct priority foundation items or HACCP plan deviations.

C. In the case of temporary food establishments, priority items shall be corrected within a maximum of 24 hours after inspection.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3940 Verification and documentation of correction

A. After observing at the time of inspection a correction of a priority item , priority foundation item, or a HACCP plan deviation, the department shall enter the observation and information about the corrective action on the inspection report.

B. As specified under 12VAC5-421-3930 B, after receiving notification that the permit holder has corrected a priority item, priority foundation item, or a HACCP plan deviation, or at the end of the specified period of time, the department shall verify correction, document the information on an inspection report, and enter the report in the department records.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3950 Core item, timeframe for correction

A. Except as specified in subsection B of this section, the permit holder shall correct core items by a date and time agreed to or specified by the department but no later than 90 calendar days after the inspection.

B. The department may approve a compliance schedule that extends beyond the time limits specified under subsection A of this section if a written schedule of compliance is submitted by the permit holder and no health hazard exists or will result from allowing an extended schedule for compliance.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3960 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016; repealed, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3961 Hold order, justifying conditions, and removal of food

Upon written notice to the owner, permit holder, or person in charge, the department may place a hold order on food that:

1. Originated from an unapproved source;

2. May be unsafe, adulterated, or not honestly presented; or

3. Is not otherwise in compliance with this chapter.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3962 Hold order, contents

The hold order notice shall:

1. State food subject to the order may not be used, sold, moved from the food establishment, or destroyed without a written release of the order from the department;

2. State the specific reasons for placing the food under the hold order with reference to the applicable provisions of this chapter and the hazard or adverse effect created by the observed condition;

3. Sufficiently identify the food subject to the hold order by the common name, the label information, a container description, quantity, department's tag or identification information, and location; and

4. Notify the permit holder of the right to request an informal fact-finding conference pursuant to the Virginia Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) within 10 calendar days of receipt of the hold order notice. Otherwise, the food under the hold order shall be destroyed by the owner, permit holder, or the person in charge.

History

• Statutory Authority: §§ 35.1.11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3963 Hold order, official tagging of food

A. The department shall securely place an official tag or label on the food or containers or otherwise conspicuously identity food subject to the hold order.

B. The tag or label used to identify a food subject to a hold order shall include a summary of the provisions specified in 12VAC5-421-3962 and shall be signed and dated by the department.

C. Only the department may remove hold order tags, labels, or other identification from food subject to a hold order.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3964 Hold order, food may not be used or moved

A. Except as specified in subsection B of this section, food placed under a hold order may not be used, sold, served, or moved from the food establishment.

B. The department may allow the permit holder to store the food in an area of the food establishment if the food is protected from subsequent deterioration.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3965 Appeals, releasing hold order

A. Any appeal of a hold order must be made in writing and received by the department within 10 calendar days of receipt of the hold order.

B. The department shall issue a notice of release from a hold order and shall remove hold tags, labels, or other identification from the food if the hold order is lifted.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-3966 Destroying or denaturing food

The department may order the permit holder to bring food under a hold order into compliance with this chapter or to destroy or denature food if:

1. Following an informal fact-finding conference held pursuant to the Virginia Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia), the department affirms the hold order; or

2. The permit holder fails to file an appeal within 10 calendar days of receipt of the hold order notice.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 18, eff. June 10, 2021; amended, Virginia Register Volume 41, Issue 7, eff. January 2, 2025.

12VAC5-421-3970 Enforcement of regulation

A. The department shall implement and enforce this chapter.

B. Pursuant to the authority granted in §§ 32.1-26 and 35.1-6 of the Code of Virginia, the commissioner may issue orders to require an owner or permit holder or other person to comply with the provisions of this chapter. The order may require the following:

1. The immediate cessation and correction of the violation;

2. Appropriate remedial action to ensure that the violation does not continue or recur;

3. The submission of a plan to prevent future violations;

4. The submission of an application for a variance; and

5. Any other corrective action deemed necessary for proper compliance with this chapter.

C. The commissioner may act as the agent of the board to enforce all effective orders and this chapter. Should an owner or permit holder fail to comply with any effective order or this chapter, the commissioner may:

1. Institute a proceeding to revoke the owner's or permit holder's permit in accordance with 12VAC5-421-3780;

2. Request the attorney for the Commonwealth to bring a criminal action;

3. Request the Attorney General to bring an action for civil penalty, injunction, or other appropriate remedy; or

4. Do any combination of the requirements listed in subdivisions 1, 2, or 3 of this subsection.

D. Nothing contained in this section shall be interpreted to require the commissioner to issue an order prior to seeking enforcement of any regulations or statute through an injunction, mandamus, or criminal prosecution.

E. Proceedings before the commissioner or a designee shall include any of the following types depending on the nature of the controversy and the interests of the parties involved:

1. An informal fact-finding proceeding, which is an informal conference between the department and the named party held in accordance with § 2.2-4019 of the Code of Virginia.

2. An adjudicatory hearing, which is a formal, public adjudicatory proceeding before a hearing officer as defined by § 2.2-4001 of the Code of Virginia and held in conformance with § 2.2-4020 of the Code of Virginia.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016; Volume 37, Issue 18, eff. June 10, 2021; Volume 41, Issue 7, eff. January 2, 2025.

12VAC5-421-3980 Request for informal fact-finding conference

A request for an informal fact-finding conference shall be made by sending the request in writing to the district or local health department in the locality where the food establishment is located. Requests for an informal fact-finding conference shall cite the reason or reasons for the request and shall cite the section or sections of this chapter involved and must be received within 30 days of the decision by the department that lead to the request.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-3990 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; repealed, Virginia Register Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-4000 Appeals

A. Any appeal from a denial of a permit to operate a food establishment must be made in writing and received by the department within 30 days after service of the denial.

B. Pursuant to the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) an aggrieved owner or permit holder may appeal a final case decision of the commissioner to an appropriate circuit court.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 32, Issue 22, eff. July 12, 2016.

12VAC5-421-4010 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; repealed, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-4020 Compliance with the Uniform Statewide Building Code

All buildings or structures utilized as food establishments constructed prior to the effective date of the Virginia Uniform Statewide Building Code shall be maintained in conformance with the Virginia Fire Safety Law or other code in effect at the time of construction.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-4030 Local ordinance superseded; exception

The regulations of the board shall supersede all local ordinances regulating restaurants other than those adopted pursuant to the provisions of § 35.1-26 of the Code of Virginia, except that any locality may adopt ordinances regarding the sale, preparation, and handling of food provided such ordinances are equivalent to, or more stringent in regard to public health than, the applicable provisions of Title 35.1 and the regulations of the board. Where local ordinances prevail, local permits may be issued as required by the local ordinances. However, this does not preclude the requirement to issue a department permit before providing food services for the public.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-421-4035 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 24, Issue 2, eff. October 16, 2007; amended, Virginia Register Volume 35, Issue 1, eff. October 3, 2018; repealed, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-4040 Investigation and control, obtaining information: personal history of illness, medical examination, and specimen analysis

The department shall act when it has reasonable cause to believe that a food employee or conditional employee has possibly transmitted disease; may be infected with a disease in a communicable form that is transmissible through food; may be a carrier of infectious agents that cause a disease that is transmissible through food; or is affected with a boil, an infected wound, or acute respiratory infection, by:

1. Securing a confidential medical history of the employee suspected of transmitting disease or making other investigations as deemed appropriate; and

2. Requiring appropriate medical examinations, including collection of specimens for laboratory analysis, of a suspected food employee or conditional employee.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 26, Issue 7, eff. January 1, 2010; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-4050 Restriction or exclusion of food employee, or summary suspension of permit

Based on the findings of an investigation related to a food employee or conditional employee who is suspected of being infected or diseased, the department may issue an order to the suspected food employee, conditional employee, or permit holder instituting one or more of the following control measures:

1. Restricting the food employee or conditional employee;

2. Excluding the food employee or conditional employee; or

3. Closing the food establishment by summarily suspending a permit to operate in accordance with law.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-4060 Restriction or exclusion order: warning or hearing not required, information required in order

Based on the findings of the investigation as specified in 12VAC5-421-4040 and to control disease transmission, the department may issue an order of restriction or exclusion to a suspected food employee or the permit holder without prior warning, notice of a hearing, or a hearing if the order:

1. States the reasons for the restriction or exclusion that is ordered;

2. States the evidence that the food employee or permit holder shall provide in order to demonstrate that the reasons for the restriction or exclusion are eliminated;

3. States that the suspected food employee or the permit holder may request an appeal hearing by submitting a timely request as provided in law; and

4. Provides the name and address of the department representative to whom a request for an appeal hearing may be made.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

12VAC5-421-4070 Release of food employee from restriction or exclusion

The regulatory authority shall release a food employee, or conditional employee from restriction or exclusion according to law and the conditions specified under 12VAC5-421-100.

History

• Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010.

Chapter 431 Sanitary Regulations for Hotels

Part I Definitions and General Provisions

12VAC5-431-10 Definitions

The following words and terms when used in these regulations shall have the following meanings, unless the context clearly indicates otherwise:

"Agent" means a legally authorized representative for the owner.

"Approved water supply" means a waterworks that has a valid waterworks operation permit from the department or a water supply that is evaluated for compliance with the Private Well Regulations (12VAC5-630), tested, and if found in reasonable compliance with the applicable standards, accepted and approved by the commissioner or the commissioner's designee.

"Bed and breakfast facility" means a residential-type establishment that provides two or more rental accommodations and food service on any single day to a maximum of 18 transient guests for a period of five or more days in any calendar year or any residential type of facility providing at least one rental accommodation for transient guests and food service for a total of 30 or more days in any calendar year.

"Commissioner" means the state health commissioner or his designee who has been delegated powers in accordance with subdivision 2 of 12VAC5-431-40.

"Department" means the Virginia Department of Health.

"Director" means the local health director or his subordinate who has been delegated powers in accordance with subdivision 2 of 12VAC5-431-40.

"District health department" means a consolidation of local health departments as authorized in § 32.1-31 C of the Code of Virginia.

"Division" means the Division of Food and Environmental Services of the Virginia Department of Health.

"Employees" means and includes all maids, porters, and any other persons whose duties include the cleaning of rooms, toilets, or any part of the building, or the rendering of service to guests.

"Hot water" has the meaning as defined by the Virginia Uniform Statewide Building Code.

"Hotel" means any establishment offering to the public for compensation transitory lodging or sleeping accommodations, overnight or otherwise, including but not limited to facilities known by varying nomenclatures or designations as hotels, motels, travel lodges, tourist homes, or hostels and similar facilities by whatever name called that consist of two or more lodging units.

"Local health department" means the department established in each city and county in accordance with § 32.1-30 of the Code of Virginia.

"Lodging unit" means any room that is established and maintained for use as a sleeping area for temporary occupancy.

"Office" means the Office of Environmental Health Services of the Virginia Department of Health.

"Operator" means any person who is responsible for the daily operation of a hotel.

"Owner" means any person who owns, leases, or proposes to own or lease a hotel.

"Permit" means a license to operate a hotel.

"Person" means an association, a corporation, individual, partnership, other legal entity, government, or governmental subdivision or agency.

"Person in charge" means the individual present at a hotel who is responsible for the operation at the time of inspection.

"Sanitary survey" means an investigation or inspection of any condition that may affect public health.

"Sewage" means water-carried and nonwater-carried human excrement and kitchen, laundry, shower, bath, or lavatory wastes separately or together with such underground, surface, storm and other water and liquid industrial wastes as may be present from residences, buildings, vehicles, industrial establishments or other places.

"Sewage disposal system" means a sewerage system or treatment works designed not to result in a point source discharge.

"Sewer" means any sanitary or combined sewer used to convey sewage or municipal or industrial wastes.

"Sewerage system" means pipelines or conduits, pumping stations and force mains and all other construction, devices and appliances appurtenant thereto used for the collection and conveyance of sewage to a treatment works or point of ultimate disposal.

"Single-service articles" means cups, containers, lids, closures, plates, knives, forks, spoons, stirrers, paddles, straws, napkins, wrapping materials, wooden chopsticks, toothpicks and similar articles intended for one-time, one-person use and then discarded.

"Swimming pool" means any structure, basin chamber, or tank, located either indoors or outdoors, containing an artificial body of water intended to be used for swimming, wading, diving or recreational bathing, including spas and hot tubs, and having a water depth of 24 inches or more at any point.

"Transient" means any individual who occupies a lodging unit in a hotel.

"Treatment works" means any device or system used in the storage, treatment, disposal or reclamation of sewage or combinations of sewage and industrial wastes, including but not limited to pumping, power and other equipment and appurtenances, septic tanks, and any works, including land, that are or will be (i) an integral part of the treatment process or (ii) used for the ultimate disposal of residues or effluents resulting from such treatment.

"Variance" means a conditional waiver to a specific regulation granted by the commissioner pursuant to 12VAC5-431-100 to a specific owner relating to a specific situation or facility and may be for a specified time period.

"Virginia Uniform Statewide Building Code" means 13VAC5-61 of the Virginia Administrative Code.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-20 Purpose of regulations

These regulations have been promulgated by the State Board of Health to specify the following requirements to protect public health:

1. Criteria for assuring the safe preparation, handling, protection or temperature control for food;

2. Criteria for maintaining physical plant sanitation;

3. Criteria for the storage and cleansing of linens and towels;

4. Criteria for general housekeeping and maintenance;

5. Requirements for approved water and sewage disposal systems;

6. Criteria for vector and pest control;

7. Criteria for ice machines and dispensers of perishable food items; and

8. Procedure for obtaining a license.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-30 Applicability of other Virginia regulations to hotels

A. The following Virginia regulations shall be applicable to hotels:

1. Food Regulations (12VAC5-421).

2. Sewage Handling and Disposal Regulations (12VAC5-610).

3. Waterworks Regulations (12VAC5-590).

4. Sewerage Regulations (12VAC5-580).

5. Private Well Regulations (12VAC5-630).

6. Regulations Governing Tourist Establishment Swimming Pools and Other Public Pools (12VAC5-460).

7. Swimming Pool Regulations Governing the Posting of Water Quality Test Results (12VAC5-462).

B. These regulations are in addition to the requirements of the Virginia Uniform Statewide Building Code (13VAC5-61).

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-40 Administration of regulations

These regulations are administered by the following:

1. State Board of Health. The State Board of Health has the responsibility to promulgate, amend and repeal regulations necessary to protect the public health.

2. State Health Commissioner. The State Health Commissioner is the chief executive officer of the State Department of Health. The commissioner has the authority to act for the board when it is not in session (See § 32.1-20 of the Code of Virginia). The commissioner may delegate his powers under these regulations in writing to any subordinate.

3. State Department of Health. The State Department of Health is designated as the primary agent of the board for the purpose of administering these regulations.

4. District or local health department. The district or local health department is responsible for implementing and enforcing the regulatory activities required by these regulations.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-50 Right of entry and inspections

In accordance with the provisions of § 35.1-5 of the Code of Virginia, the commissioner or his designee shall have the right to enter any property to ensure compliance with these regulations.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

Part II Procedural Regulations

12VAC5-431-60 Applicability of Administrative Process Act

The provisions of the Virginia Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) shall govern the procedures for rendering all case decisions.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-70 Emergency orders

The commissioner may, pursuant to § 32.1-13 of the Code of Virginia, issue emergency orders that are necessary to preserve the public health, safety, welfare and environment. Emergency orders arising out of matters governed by these regulations shall state the reasons and factual basis upon which the emergency order is issued. The emergency order shall state the time period for which it is effective.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-80 Enforcement of regulations

A. Notice. Whenever the commissioner has reason to believe that a violation of Titles 32.1 or 35.1 of the Code of Virginia or any provisions of these regulations has occurred or is occurring, the district or local health department shall so notify the alleged violator. Such notice shall: (i) be in writing, with a request to the owner to respond by providing any pertinent information relating to the issue; (ii) cite the statute, regulation or regulations that are allegedly being violated; and (iii) state the facts which form the basis for believing that the violation has occurred or is occurring. Such notification is not an official finding or case decision nor an adjudication, but may be accompanied by a request that certain corrective action be taken.

B. Orders. Pursuant to the authority granted in §§ 32.1-26 and 35.1-6 of the Code of Virginia, the commissioner may issue orders to require any owner or other person to comply with the provisions of these regulations. The order may require the following:

1. The immediate cessation and correction of the violation;

2. Appropriate remedial action to ensure that the violation does not continue or recur;

3. The submission of a plan to prevent future violations;

4. The submission of an application for a variance; and

5. Any other corrective action deemed necessary for proper compliance with the regulations.

C. Hearing before the issuance of an order. Before the issuance of an order, the commissioner must comply with the requirements of § 35.1-6 of the Code of Virginia.

D. When order effective. All orders issued pursuant to this section shall become effective not less than 15 days after mailing a copy thereof by certified mail to the last known address of the owner or person violating these regulations or the address provided by the applicant on his application to operate a hotel. Violation of an order is a Class 3 misdemeanor. See § 35.1-7 of the Code of Virginia.

E. Compliance. The commissioner may act as the agent of the board to enforce all effective orders and these regulations. Should any person fail to comply with any effective order or these regulations, the commissioner may do any or all of the following:

1. Institute a proceeding to revoke the owner's permit in accordance with 12VAC5-431-320;

2. Request the attorney for the Commonwealth to bring a criminal action; or

3. Request the Attorney General to bring an action for civil penalty, injunction, or other appropriate remedy.

F. Not exclusive means of enforcement. Nothing contained in 12VAC5-431-70 or this section shall be interpreted to require the commissioner to issue an order prior to seeking enforcement of any regulation or statute through an injunction, mandamus or criminal prosecution.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-90 Suspension of regulations during disasters

If in the case of a man-made or natural disaster, the commissioner finds that certain regulations cannot be complied with and that the public health is better served by not fully complying with these regulations, he may authorize the suspension of the application of the regulations for specifically affected localities and institute a provisional regulatory plan until the disaster is abated.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-100 Variances

A. The commissioner may grant a variance to these regulations by following the appropriate procedures set forth in this section.

B. Requirements for a variance. The commissioner may grant a variance if he finds that the hardship imposed, which may be economic, outweighs the benefits that may be received by the public and that granting such a variance does not subject the public to unreasonable health risks or environmental pollution.

C. Application for a variance. Any owner who seeks a variance shall apply in writing to the local health department. All requests for variances must be made in writing and received by the local health department prior to denial of the hotel permit or within 30 days after such denial. The application for a variance shall include:

1. A citation to the regulation from which a variance is requested;

2. The nature and duration of the variance requested;

3. Any relevant analytical data including result of relevant tests conducted pursuant to the requirements of these regulations;

4. Statements or evidence that establishes that the public health, welfare and environment would not be adversely affected if the variance were granted;

5. Suggested conditions that might be imposed on the granting of a variance that would limit the detrimental impact on the public health and welfare;

6. Other information believed pertinent by the applicant; and

7. Such other information as the district or local health department or commissioner may require.

D. Evaluation of a variance application. The commissioner shall act on any variance request submitted pursuant to subsection C of this section within 60 days of receipt of the request. In evaluating a variance application, the commissioner shall consider such factors as the following:

1. The effect that such a variance would have on the operation of the hotel;

2. The cost and other economic considerations imposed by this requirement;

3. The effect that such a variance would have on protection of the public health, safety, welfare and the environment; and

4. Such other factors as the commissioner may deem appropriate.

E. Disposition of a variance request. The commissioner may grant, modify or deny a variance request.

1. If the commissioner denies a variance request, he shall provide the owner an opportunity to an informal hearing as defined by § 2.2-4019 of the Code of Virginia. Following this opportunity for an informal hearing, the commissioner may reject any application for a variance by sending a rejection notice to the applicant. The rejection notice shall be in writing and shall state the reasons for the rejection. A rejection notice constitutes a case decision.

2. If the commissioner proposes to grant a variance request, the applicant shall be notified in writing of this decision. Such notice shall identify the variance and the hotel involved and shall specify the period of time for which the variance will be effective. Such notice shall provide that the variance will be terminated when the hotel comes into compliance with the applicable regulation and may be terminated upon a finding by the commissioner that the hotel has failed to comply with any requirements or schedules issued in conjunction with the variance. The effective date of the variance shall be as noted in the variance letter.

3. All variances granted to any hotel may be transferable unless otherwise stated. Each variance shall be attached to the permit to which it is granted. Each variance is revoked when the permit to which it is attached is revoked.

4. No owner may challenge the terms or conditions of a variance after 30 calendar days have elapsed from the receipt of the variance.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-110 Hearing types

Hearings before the commissioner or his designee shall include any of the following forms depending on the nature of the controversy and the interests of the parties involved:

1. Informal hearings. An informal hearing is a meeting with an employee or director of the district or local health department held in conformance with § 2.2-4019 of the Code of Virginia.

2. Adjudicatory hearing. An adjudicatory hearing is a formal, public adjudicatory proceeding before the commissioner or a designated hearing officer held in conformance with § 2.2-4020 of the Code of Virginia.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-120 Request for hearing

A request for an informal hearing shall be made by sending the request in writing to the district or local health department in the locality where the hotel is located. Requests for hearings shall cite the reason or reasons for the hearing request and the section or sections of these regulations involved and must be received within 30 days of the decision by the district or local health department that led to the hearing request.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-130 Hearing as a matter of right

Any person or named party whose rights, duties, or privileges have been or may be affected by any case decision made in the administration of these regulations shall have a right to both informal and adjudicatory hearings. The commissioner may require participation in an informal hearing before granting the request for a full adjudicatory hearing. EXCEPTION: No person other than an owner shall have the right to an adjudicatory hearing to challenge the issuance of a permit to operate unless the person can demonstrate at an informal hearing that the minimum standards contained in these regulations have not been applied and that he will be injured in some manner by the issuance of the permit.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-140 Appeals

A. Any appeal from a denial of a permit to operate a hotel must be made in writing and received by the local health department within 30 days of the date the denial letter was received.

B. Any request for hearing on the denial of an application for a variance pursuant to 12VAC5-431-100 E 1 must be made in writing and received within 30 days of receipt of the denial notice.

C. Pursuant to the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia), an aggrieved owner may appeal a final decision of the commissioner to the appropriate circuit court.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-150 Grandfather clause

Permits granted to hotels prior to March 1, 2002, shall remain valid until ownership changes or unless conditions at the hotel change in a manner that would adversely affect the public health, safety, welfare, or environment. Necessary alterations, modifications or repairs to a hotel shall not be grandfathered and shall comply with the version of the Virginia Uniform Statewide Building Codes in effect at the time the changes are made.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-160 Submission of plans, specifications and other data

Whenever a hotel is constructed or remodeled or whenever an existing structure is converted to use as a hotel, properly prepared plans and specifications for such construction, remodeling, or conversion shall be submitted to the director for review and approval before construction, remodeling or conversion is begun. The plans and specifications shall detail such items as the layout of the hotel, plans for proposed buildings and structures, the proposed water source and distribution system, and the proposed sewage disposal system. Detailed plans and specifications shall be submitted for the food service establishment and swimming pool, if applicable. The director or the designee shall approve the plans and specifications if they meet the requirements of these regulations. No hotel shall be constructed, remodeled, or converted except in accordance with plans and specifications approved by the director or the designee. The director may waive the requirement for plans for minor modifications and renovations.

Whenever plans and specifications are required to be submitted to and approved by the director or his designee, he shall inspect the hotel prior to its beginning operation to determine compliance with the approved plans and specifications and with the requirements of these regulations.

The director's or designee's approval of any plans or specifications is no guarantee that plans or specifications are without error and the owner shall have final responsibility for the accuracy and completeness of the plan and specifications, including subsequent construction and installation.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-170 Application for a permit

Any person desiring to operate a hotel shall make written application for a permit on an approved application form at least 30 days prior to the opening of the hotel. As a minimum, such application shall include the name and address of the applicant who intends to operate the hotel, the proposed dates of operation, the number of rooms expected to be served on the busiest day, the type of sewage disposal system to be used, the type of water supply that will service the facility and the signature of the applicant. Upon review of the application, the director may require the applicant to submit such additional information as is required to evaluate the applicant's application for the permit.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-180 Permits

A. No person shall own, establish, conduct, maintain, manage, or operate any hotel in this Commonwealth unless the hotel is permitted as provided in this section. All permits shall be in the name of the owner or lessee. Permits shall not be issued to newly constructed or extensively remodeled hotels until a certificate of occupancy has been issued by the building official. Only a person who complies with the requirements of these regulations shall be entitled to receive or retain such a permit.

B. Nontransference of hotel permits. Permits issued after March 1, 2002, shall not be transferable from one person to another or from one location to another. A new owner shall be required to make a written application for a permit. The application forms are obtainable at all local health departments.

C. Conditional permits. A conditional permit authorizes the owner of a hotel to operate the hotel under certain controlled conditions, which may include, but are not limited to, restrictions of the types of food the hotel can handle and type of swimming facility made available for public use.

D. Requirements for posting permits. The permit shall be posted in a place where it is readily observable by the public transacting business with the hotel.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-190 Issuance of a permit

Prior to the issuance of a permit, the director or his designee shall inspect the hotel to determine compliance with the requirements of these regulations. The department shall issue a permit to the applicant if its inspection reveals that the proposed hotel complies with the requirements of these regulations. The permit shall remain in effect (i.e., is self-renewing) unless otherwise suspended, revoked or surrendered by the owner. Ownership or lessee changes void the permit and the new owner must apply for a new permit.

A permit may be issued for a hotel that substantially complies with the criteria set forth in these regulations. The director shall be responsible for determining what constitutes substantial compliance.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-200 Denial of a permit

Whenever the department denies a hotel permit it shall, within 10 days of the inspection, send the applicant a written explanation of the reasons why the permit was denied.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-210 Suspension of a permit

The director may suspend a permit to operate a hotel without an informal conference if the director finds the continued operation constitutes a substantial and imminent threat to the public health. Upon receipt of such notice that a permit is suspended, the permit holder shall cease operation immediately and begin corrective action.

Whenever a permit is suspended, the holder of the permit or the person in charge shall be notified in writing by certified mail or by hand delivery. Upon service of notice that the permit is immediately suspended, the former permit holder shall be given an opportunity to request an informal hearing. If a permit holder wants to request an informal hearing, he must submit a request in writing to the director within 10 working days after he receives notice of the suspension. The written request shall be filed with the local department by the former holder of the permit. If a written request for an informal hearing is not filed within 10 working days, the suspension is sustained. Each holder of a suspended permit shall be afforded an opportunity for an informal hearing within three working days of receipt of a request for an informal hearing. The director may end the suspension at any time if the reasons for suspension no longer exist.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-220 Revocation of a permit

Prior to revocation, the director shall notify in writing the holder of the permit, or the person in charge, of the specific reason or reasons for which the permit is to be revoked. The permit shall be revoked at the end of the 30 days following service of such notice unless a written request for an informal conference is filed before then with the director. If no request for an informal conference is filed within the 30-day period, the revocation of the permit shall be final.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-230 Permits issued under prior regulations

Permits granted prior to March 1, 2002, shall not require a new permit so long as the ownership of the hotel has not changed and the permit holder otherwise complies with these regulations.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-240 Application after revocation

Any person whose permit has been revoked may apply for a new permit after complying with these regulations by following the procedures in 12VAC5-431-170.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-250 Periodic inspection

Hotels shall be inspected by the designee of the commissioner. Annual random inspections shall be conducted on a percentage of hotels within each locality. Additional inspections shall be conducted in response to complaints filed with the department that directly affect the health and safety of the public. Further inspections shall be conducted as often as necessary for the enforcement of these regulations. It shall be the responsibility of the operator of a hotel to give the health commissioner or his designee free access to such premises at reasonable times for the purpose of inspection in accordance with § 35.1-5 of the Code of Virginia.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-260 Inspection report

Whenever an inspection of a hotel is made, the findings shall be recorded on the department's inspection report forms.

The original of the completed inspection report form shall be furnished to the person in charge of the hotel at the conclusion of each inspection. The completed inspection report form, being a public document, shall be made available for public disclosure to any person who requests it according to law.

The inspection report shall state any failure to comply with any time limit for corrections and may result in the closing of the hotel. An opportunity for an informal conference on the inspection findings, a time limit, or both, shall be granted provided that a written request is filed with local health department within 10 days following the inspection or the cessation of operations. When a request for a hearing is received, the procedures outlined in 12VAC5-431-120 shall be followed.

Whenever a hotel is required to cease operation under the provisions of 12VAC5-431-210, it shall not resume operations until a reinspection shows that conditions responsible for the order to cease operations no longer exists. Following a request for reinspection, it shall be made as soon as possible or within three working days.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-270 Correction of violations

The completed inspection report form may specify a reasonable period of time for the correction of the violations found. Where a period of time for the correction is specified, the correction shall be accomplished within the period specified and in accordance with the following provisions:

1. Should a substantial and imminent health hazard be declared by the director, including but not limited to substantial fire damage, sewage backing into the food preparation and service areas, lack of refrigeration or lack of water, the operator shall immediately cease operations. Operations shall not be resumed until authorized by the director. Authorization shall not be granted until such violations are corrected.

2. All violations specifying a reasonable period of time for correction shall be corrected as soon as possible, but in any event, within the period of time specified. A follow-up inspection shall be conducted by the director or his designee to confirm the corrections.

3. All violations specifying a reasonable period of time for correction shall be corrected as soon as possible, but in any event, within the period of time specified. A follow-up inspection shall be conducted by the director or his designee to confirm the corrections.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

Part III Design, Construction and Operational Criteria

12VAC5-431-280 Supervision

The operator of a hotel, or his designated representative who is responsible for the premises, shall be available on the premises while it is open for use.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-290 General sanitation

All buildings, other facilities, equipment fixtures, furnishings and the premises of a hotel shall be kept clean, in good repair, and maintained so as to protect the health, safety, and well-being of persons using those facilities.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-300 Floor requirements

The floors of all lodging units, hallways, store rooms and all other spaces used or traversed by guests shall be of such construction as to be easily cleaned and shall be kept clean and in good repair. The requirements of this section shall not prevent the use of rugs, carpets, or natural flooring so long as they are clean and in good repair. Abrasive strips for safety purposes may be used wherever deemed necessary to prevent accidents.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-310 Walls and ceiling requirements

The walls and ceilings of all lodging units, hallways, bathrooms, store rooms and all other spaces used or traversed by guests shall be of such construction as to be easily cleaned, shall be smooth, and shall be kept clean and in good repair. Cleaning of walls and ceilings shall be so done as to minimize the raising of dust and the exposure of guests thereto. Studs, joists, or rafters shall not be left exposed except when suitably finished and kept clean.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-320 Room furnishing requirements

All equipment, fixtures, furniture, windows, and furnishings, including draperies, curtains, carpets, other floor materials shall be kept clean and free of dust, dirt, vermin, and other contaminants and shall be maintained in good order and repair.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-330 Air volume, heat, light, and ventilation requirements

The air volume, heat, light, and ventilation of each lodging unit shall be constructed and maintained in accordance with the Virginia Uniform Statewide Building Code.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-340 Box springs, mattresses, bedding and linen requirements

A. Box springs and mattresses shall be clean and in good repair.

B. Conventional mattress covers or pads shall be used for the protection of mattresses and shall be kept clean and in good repair.

C. All sheets, pillowcases, towels, washcloths, and bathmats shall be kept clean and in good repair, freshly laundered and sanitized between occupants and changed at least once every 7 days if used by the same occupant.

D. When a blanket is placed on the bed, the upper sheet shall be of sufficient length to fold and overlap the top section of the blanket.

E. All clean bedding and linen shall be stored in a clean and dry place.

F. All soiled bedding and linen shall be handled and stored so as not to contaminate clean bedding and laundry.

G. Containers for transporting or storing bedding and linen shall be constructed of impervious materials and shall be smooth and easily cleanable.

H. Laundry storage rooms shall be separated from staff living quarters and be kept in a clean and organized fashion. EXEMPTION: This subsection shall not apply to bed and breakfast facilities.

I. All blankets, quilts, bedspreads, and comforters shall be maintained in a sanitary and good condition.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-350 Bed spacing requirements

A. Bed arrangements of lodging units shall provide not less than 24 inches clear space between each bed, cot, or bunk.

B. No lodging unit shall contain more than two tiers of beds. When two tiers are used, there shall be at least:

1. Three feet of clear vertical space between tiers of beds and between the top tier and ceiling; and

2. Four feet of space between tiered beds.

C. There shall be sufficient space between the floor and the underside of the beds to facilitate easy cleaning. In lieu of such space, the bed shall have a continuous base or shall be on rollers.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-360 Toilet, lavatory, and bath facilities requirements

A. The required number of sanitary fixtures shall be in accordance with the Virginia Uniform Statewide Building Code.

B. Toilets, lavatories and bath facilities shall be maintained in a clean and sanitary condition and maintained in good repair.

C. The location and use of all public toilet and bath facilities shall be clearly indicated by appropriate signs.

D. Toilet, lavatory, and bath facilities for hotel patrons located in private homes shall be separate from toilet and bath facilities utilized by the owner or operator of said hotel.

E. All lavatories, bathtubs, and showers shall be provided with hot and cold water, except where otherwise specifically exempted by the department.

F. Toilet and bath facilities shall have:

1. Floors that are finished with a material that is smooth, easily cleanable, impervious to water, and coved to a height of four inches. The use of carpet is prohibited.

2. Shower compartments with walls that are in accordance with the Virginia Uniform Statewide Building Code. An effective water-tight joint between the wall and the floor shall be maintained.

3. Interior finishes that are smooth, easily cleanable, and impervious to water.

4. Where rubber or impervious mats are used, such mats clean and dry between usages.

5. Bathtub and shower stall floors that are finished with nonslip, impervious surfaces or provided with nonslip impervious bath mats.

6. Where glass bath or glass shower doors are used, such doors made of safety glass.

7. Toilet tissue, soap, towels, and a waste receptacle provided.

G. All plumbing installations shall be in accordance with the Virginia Uniform Statewide Building Code.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-370 Solid waste

A. A minimum of one watertight, nonabsorbent and easily washable waste receptacle shall be provided in each lodging unit. Such receptacle shall be kept clean and in good repair.

B. Solid waste shall be collected daily from rooms and areas used by guests.

C. Solid waste shall be disposed of in accordance with all applicable local ordinances and state laws and regulations.

D. Solid waste shall be stored in either individual garbage containers, bins, or storage vehicles.

E. All such bulk storage containers or vehicles shall:

1. Have tight fitting lids or covers;

2. Be durable, rust resistant, water tight, rodent proof, readily washable, and kept in good repair.

F. Solid waste shall be removed from the hotel's premises at regular intervals. Collection frequency shall be such so as not to create:

1. Vector production and sustenance;

2. Objectionable odors; or

3. Any overflowing of solid waste or other unsanitary condition.

G. Solid Waste shall be transported in accordance with all applicable local ordinances and state law and regulation.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-380 Vector control

A. Vector control measures shall be employed to prevent vector infestations in or around hotels.

B. Insect and rodent control measures to safeguard public health and to prevent nuisance to the public shall be applied. Developed areas, buildings, and structures shall be maintained free of accumulations of debris.

C. Application of pesticides or rodenticides shall be conducted by a Virginia Department of Agriculture and Consumer Services certified pesticide applicator or under the direct supervision of a Virginia Department of Agriculture and Consumer Services certified applicator.

D. The presence of any rodent, such as mice and rats, reptiles or any insect infestation shall be evidence that sufficient vector control measures have not been implemented at the hotel and shall be considered a violation of these regulations.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-390 Spas, swimming pools, and other swimming facilities

Any spa, swimming pool, or other swimming facility located at or operated in connection with a hotel shall comply with the department's swimming pool regulations as specified in 12VAC5-431-30.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; Errata, 33:9 VA.R. 977 December 26, 2016.

12VAC5-431-400 Water supply systems

A. Water supply systems serving hotels shall comply with the department's Waterworks Regulations or Private Well Regulations as specified in 12VAC5-431-30.

B. The water supply distribution system shall be designed, constructed, and maintained in compliance with the Virginia Statewide Uniform Building Code.

C. Water heaters shall have installed an approved ASME pressure relief valve that is accessible for inspection and testing.

D. Where drinking fountains are provided, they shall be of an angle jet type with adequate water pressure at all times.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; Errata, 33:9 VA.R. 977 December 26, 2016.

12VAC5-431-410 Sewage disposal

A. Hotels shall provide an adequate and safe sewerage system.

B. Sewage and waste water shall be disposed of into a public sewerage system or by a sewage system constructed and operated in accordance with applicable laws and regulations of the department.

C. No untreated or partially treated sewage, liquid waste, or septic tank effluent shall be discharged directly or indirectly onto the surface of the ground or into public waters.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-420 Fire safety

Hotels shall comply with the requirements of the Virginia Statewide Fire Prevention Code (13VAC5-51).

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-430 Chemical and physical hazards

A. Cleaning equipment, supplies, pesticides, rodenticides, chemicals, paints, and other toxic substances shall be kept isolated from guests and stored so as to prevent contamination of clothing, toweling, and bedding materials. All applications of chemicals including, but not limited to, cleaners and disinfectants shall be in accordance with the manufacturers' recommendations.

B. All toxic substances shall be clearly identified and accurately labeled as toxic.

C. Housekeeping carts shall be kept organized such that clean linens, single-service articles, ice buckets, and glassware stored on these units shall be protected from contamination by toilet brushes, soiled linen, cleaning agents, or any other possible sources of contamination.

D. All stairways shall be provided with firmly attached handrails and guardrails in accordance with the Virginia Uniform Statewide Building Code.

E. All boilers and pressure vessels shall be approved and maintained in accordance with the applicable state statutes.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-440 Food services

A. Eating and drinking establishments, commissaries, mobile units, and vending machines operated in conjunction with a hotel shall be operated in compliance with the Food Regulations (12VAC5-421).

B. When reusable glassware is provided by the hotel, it must be properly washed, rinsed, and sanitized. An approved three-compartment sink or a commercial dishwashing machine shall be provided in a kitchen or separate room for the purpose of performing this function. Sanitized glassware shall be stored in a clean site that is removed from sources of contamination. A single-service cover is to be placed on the opening of the glassware prior to its removal from the cleaning site. If this cover is removed by the guest, then the glassware is presumed to be soiled and shall be washed and sanitized.

C. Single-service articles shall be properly stored and protected from contamination. The reuse of these items is prohibited.

D. Ice buckets shall be constructed and repaired with safe materials and shall be corrosive resistant, nonabsorbent, nontoxic, smooth, easily cleanable and durable under conditions of normal use. Single-service ice buckets may be used if intended for one use only and if made from clean, sanitary safe materials.

E. When ice buckets are provided by hotels, they must be properly washed, rinsed and sanitized. An approved three-compartment sink or commercial dishwashing machine shall be provided in the kitchen or a separate room for the purpose of performing this function. A food grade liner may be used in lieu of a three-compartment sink to protect ice from contamination as long as the liner and ice bucket itself are clean and of approved construction. When ice buckets are provided, they must have either an approved lid or a food grade liner available to protect ice from contamination.

F. Bottled or packaged water shall be obtained from an approved source and shall be packaged, handled, sorted and dispensed in a way that protects it from contamination.

G. Any hotel that makes ice available in public areas, including but not limited to lobbies, hallways, and outdoor areas, shall restrict access to such ice in accordance with the following provisions:

1. Newly constructed facilities. After March 1, 2002, any newly constructed hotel that installs ice-making equipment, and any existing hotel that installs or replaces ice-making equipment, shall install only automatic dispensing, sanitary ice-making and storage equipment in areas accessible to the public. Any such establishment may install open-type bin ice machines in areas not accessible to the public provided they meet the requirement of subdivision 2 of this subsection.

2. Existing facilities. After March 1, 2004, any existing hotel that has not converted to automatic dispensing, ice-making and storage shall no longer permit unrestricted public access to open-type ice bins and shall dispense ice to guests only by having employees give out prefilled, individual sanitary containers of ice or by making available prefilled, disposable, closed bags of ice.

H. EXEMPTION: Bed and breakfast facilities are exempt from subsection B of this section. Bed and breakfast facilities shall comply with all applicable sections of the Food Regulations of the Board of Health (12VAC5-421).

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-450 Lodging unit kitchens

A. Cooking by guests in lodging units that have not been equipped with kitchens or in efficiency-type kitchen facilities that do not conform to the Virginia Statewide Uniform Building Code is prohibited.

B. Kitchen-equipped lodging units shall have:

1. A sink suitable for dishwashing with hot and cold water.

2. A refrigerator capable of maintaining a food temperature of 41°F or less.

3. Utensils and equipment, if supplied, that are easily cleanable, durable, and kept in good repair. Utensils supplied in lodging units shall be washed, rinsed, and sanitized after each occupancy and have a notice stating: "For your convenience, dishes and utensils have been washed and sanitized. If you would like to further sanitize these items, please contact the manager." The sanitizing agent shall be available in the office.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-460 Examination of employees for communicable diseases

All hotel employees shall submit to such examination or examinations as may be considered necessary by the commissioner when such employees are suspected of having a communicable disease. It shall be the duty of the owner or manager of any hotel to exclude from service in the establishment any employee who is known to be infected with a communicable disease, except in circumstances individually approved by the commissioner.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-470 Pets

The person operating a hotel may establish and enforce rules designed to prohibit or control pets. No guest shall allow his pet to run at large or be a nuisance.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-480 Posting of rates and Code of Virginia sections

All operators shall post conspicuously in each lodging unit occupied by transient guests the rates for the room together with §§ 8.01-42.2, 35.1-27 and 35.1-28 of the Code of Virginia in which are prescribed the duties, liability of guests for hotel damage, and limitation of liability of guests for hotel damage from innkeepers.

History

• Statutory Authority: §§ 35.1-11 and 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002.

12VAC5-431-490 Employee training

A. Each employee, as defined in § 35.1-15.1 A of the Code of Virginia, shall by July 1, 2023, or within six months of being employed by a hotel and thereafter at least once per consecutive two-year period, complete a training course provided or approved by the Department of Criminal Justice Services pursuant to §§ 9.1-102 and 35.1-15.1 of the Code of Virginia on recognizing and reporting instances of suspected human trafficking.

B. The permit holder shall provide documentation, upon request by the department, that the hotel's employees have completed the required training.

History

• Statutory Authority: §§ 35.1-11, 35.1-13, and 35.1-15.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 10, eff. February 1, 2023.

Chapter 460 Regulations Governing Tourist Establishment Swimming Pools and Other Public Pools

Part I General Provisions

12VAC5-460-10 Definitions

The following words and terms, when used in this chapter, shall have the following meanings unless the context clearly indicates otherwise:

"Construction" means any construction, remodeling, or major alterations.

"Design load" means the maximum number of persons permitted in the pool at any given time, to be determined by dividing the total square footage of swimming pool water surface area by 27.

"Operator" or "manager" means the individual or individuals responsible for operation and management of the lodging facility and all of its facilities including the swimming pool.

"Person" means an individual, firm, corporation or association.

"State Health Commissioner" means the Commissioner of Health for the Commonwealth of Virginia.

"Swimming pool" shall mean any swimming, wading, or spray pool, including all appurtenant equipment, structures, and facilities provided for the use of guests by transient lodging establishments.

History

• Statutory Authority: § 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 1, eff. March 1, 1962.

12VAC5-460-20 Local requirements

In addition to the requirements of this chapter, all applicable local ordinances, including plumbing, building, electrical, and zoning ordinances shall also apply in the construction, maintenance, and operation of all swimming pools.

History

• Statutory Authority: § 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 2.1, eff. March 1, 1962.

12VAC5-460-30 Plan review

A. To ensure the health and safety of all swimming pool patrons, any person planning to initially open a swimming pool after construction, remodeling, or major alteration at a tourist lodging facility must, prior to operation of the swimming pool, submit to the local health department in the locality in which the tourist lodging facility is located complete plans or statements that show the following:

1. Plans for the pump and recirculation system.

2. Plans for the operation and maintenance of the pool disinfection and filtration system, including plans for the filtration room.

3. The proposed source and location of the pool water supply and the proposed method and location of all wastewater disposal systems.

4. The name and mailing address of the person operating the pool and the physical address of the pool.

5. Such other pertinent information as the State Health Commissioner may deem necessary to ensure a safe and healthy environment for users of the swimming pool.

B. When, upon review of the plans, the State Health Commissioner is satisfied that the proposed plans if executed will meet the requirements of this chapter and other pertinent laws and regulations designed to protect the public health, written approval shall be issued by the State Health Commissioner.

C. When, upon review of the plans, the State Health Commissioner determines that the proposed plans prevent a safe sanitary operation, the plans shall be disapproved and the applicant shall be notified in writing of any deficiency in the plans that constitute the basis for disapproval. The applicant shall be notified of the opportunity for administrative process as provided by the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

D. No person shall operate a tourist establishment swimming pool or spa until written approval has been granted by the State Health Commissioner.

E. Any person whose plans have been disapproved may request and shall be granted an appeal as described by the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

History

• Statutory Authority: § 35.1-11 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 3, eff. March 1, 1962; amended, Virginia Register Volume 36, Issue 1, eff. October 17, 2019.

Part II Swimming Pools; Design and Construction

12VAC5-460-40 Water supplies

All water used in swimming pools shall be from sources that are approved by the State Health Commissioner. No sewage or wastewater shall be allowed to enter the swimming pool water system. No water from the swimming pool shall be allowed to enter the make-up water supply.

History

• Statutory Authority: § 35.1-11 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 3, eff. March 1, 1962; amended, Virginia Register Volume 36, Issue 1, eff. October 17, 2019.

12VAC5-460-50 Location

The location of a pool shall in no way hinder the operation for which it is designed nor adversely affect the bathers' safety or water quality.

History

• Statutory Authority: § 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 5, eff. March 1, 1962.

12VAC5-460-60 Materials of pool shell

Swimming pool shells shall be kept clean. The interior finish shall be maintained so that it does not obscure objects or surfaces within the pool or spa.

History

• Statutory Authority: § 35.1-11 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 3, eff. March 1, 1962; amended, Virginia Register Volume 36, Issue 1, eff. October 17, 2019.

12VAC5-460-70 (Repealed.)

History

• Historical Notes: Derived from VR355-35-05 § 7, eff. March 1, 1962; repealed, Virginia Register Volume 36, Issue 1, eff. October 17, 2019.

12VAC5-460-80 Pool decks

Decks shall be maintained to have a nonslip but smooth finish. Drainage shall be directed away from the pool area in a manner that will not create or maintain pools of water or a nuisance.

History

• Statutory Authority: § 35.1-11 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 3, eff. March 1, 1962; amended, Virginia Register Volume 36, Issue 1, eff. October 17, 2019.

12VAC5-460-90 Fences

Any fences or other barriers, and any gates and latches required by the Virginia Uniform Statewide Building Code (13VAC5-63), shall be properly maintained and in good operable condition. When safety criteria for barriers are not prescribed by the Building Code in effect at the time of the pool's construction, steps shall be taken to protect against undesired access into the pool area.

History

• Statutory Authority: § 35.1-11 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 3, eff. March 1, 1962; amended, Virginia Register Volume 36, Issue 1, eff. October 17, 2019.

12VAC5-460-100 Steps and ladders

All ladders, steps, and handrails required by the Virginia Uniform Statewide Building Code (13VAC5-63) shall be properly maintained and in operable condition. Nonslip finishes shall be maintained on all pool steps, ladders, or other means of ingress or egress.

History

• Statutory Authority: § 35.1-11 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 3, eff. March 1, 1962; amended, Virginia Register Volume 36, Issue 1, eff. October 17, 2019.

12VAC5-460-110 Overflow facilities

The presence of floating material and scum is prohibited; pools shall have adequate water circulation and filtration equipment sufficient to keep floating material or scum from accumulating on the surface of the water.

History

• Statutory Authority: § 35.1-11 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 3, eff. March 1, 1962; amended, Virginia Register Volume 36, Issue 1, eff. October 17, 2019.

12VAC5-460-120 Inlets and outlets

Pool circulation systems shall produce uniform circulation of water throughout the swimming pool without the existence of dead spots.

Direct connection to a sanitary sewer shall not be permitted. When not otherwise prescribed by the Virginia Uniform Statewide Building Code (13VAC5-63) in effect at the time of the pool's construction, the outlet drain shall be covered with a grate of such design that it cannot be readily removed by or produce any hazard to the bathers.

History

• Statutory Authority: § 35.1-11 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 3, eff. March 1, 1962; amended, Virginia Register Volume 36, Issue 1, eff. October 17, 2019.

12VAC5-460-130 Depth marking

Depth markers shall be plainly visible and maintained in accordance with the Virginia Uniform Statewide Building Code (13VAC5-63). When depth markers are not prescribed by the Building Code in effect at the time of the pool's construction, steps shall be taken to ensure that the depth of all sections of the pool can be determined by swimmers.

History

• Statutory Authority: § 35.1-11 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 3, eff. March 1, 1962; amended, Virginia Register Volume 36, Issue 1, eff. October 17, 2019.

12VAC5-460-140 (Repealed.)

Historical Notes

Derived from VR355-35-05 § 14, eff. March 1, 1962; repealed, Virginia Register Volume 36, Issue 1, eff. October 17, 2019.

12VAC5-460-150 Lighting

When pools are to be used after dark, all parts of the pool, the water therein, and the entire area shall be well lit. Fixtures shall not create a hazard to the bathers. The maintenance and operation of the fixtures shall be such that lifeguards can clearly see every part of the swimming pool, including decks, spring boards, and other appurtenances, without being blinded by glare. The electrical grounding of all submarine lights shall be properly maintained.

History

• Statutory Authority: § 35.1-11 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 3, eff. March 1, 1962; amended, Virginia Register Volume 36, Issue 1, eff. October 17, 2019.

12VAC5-460-160 Food and drink facilities

Food and drink preparation, serving, consumption facilities shall be permitted only within designated areas approved for these purposes.

History

• Statutory Authority: § 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 16, eff. March 1, 1962.

12VAC5-460-170 Recirculation systems

The recirculation system, including all pumps, hair and lint catchers, filters, disinfection equipment, and necessary pipe connections to the inlets and outlets, shall be maintained in working order as designed. Adequate provision shall be made for backwashing filters. When not prescribed by the Virginia Uniform Statewide Building Code (13VAC5-63) in effect at the time of the pool's construction, recirculation systems shall be designed for an eight hour or less turnover of the swimming pool water.

History

• Statutory Authority: § 35.1-11 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 3, eff. March 1, 1962; amended, Virginia Register Volume 36, Issue 1, eff. October 17, 2019.

12VAC5-460-180 Filter rooms

Any room containing the filtration equipment, pumps, and other recirculation system appurtenances shall be finished in a light color and be provided with adequate illumination and ventilation. The floor of the filter room shall be designed to provide adequate drainage. The provision of any facility for discharging filter backwashing water onto the filter floor is strictly prohibited, and adequate provision shall be made for the discharge of backwash water. All of the recirculation equipment in filter rooms shall be installed so that it may easily be operated or repaired. All entrances below ground surface shall be by stairway and vertical door. Adequate headroom shall be provided above all filters. Below-ground filter rooms shall be provided with mechanical ventilation.

History

• Statutory Authority: § 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 18, eff. March 1, 1962.

12VAC5-460-190 Pumps

Pumping equipment shall have sufficient capacity to discharge the volume of water for the required turn-over of the pool against the maximum head in the recirculation system. The pump used for backwashing sand filters shall have sufficient capacity to backwash the unit at the rate of at least 12 gallons per minute per square foot of filter area against the maximum head developed during backwashing.

History

• Statutory Authority: § 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 19, eff. March 1, 1962.

12VAC5-460-200 Hair and lint catchers, gutters

Hair and lint catchers shall be able to be easily and simply dismantled for cleaning and inspection. Floating material and scum shall not be allowed to collect on the surface of the water.

History

• Statutory Authority: § 35.1-11 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 3, eff. March 1, 1962; amended, Virginia Register Volume 36, Issue 1, eff. October 17, 2019.

12VAC5-460-210 Filters

The filtration system shall be maintained and operated as designed. In sand filters, the layer of filter sand shall be at least 20 inches in depth, properly supported by uniform layers of clean graded gravel to a minimum depth of 12 inches or supported by porous plates. The filter sand shall have an effective size of between 0.45 and 0.55 millimeters with a uniformity coefficient not greater than 1.7. In anthracite coal filters, the anthracite shall have a depth of at least 24 inches and shall have an effective size between 0.6 and 0.8 millimeters with a uniformity coefficient of not greater than 1.8. Pressure filters shall be equipped with readily accessible air relief valves and access holes large enough to permit inspections, maintenance, and repair work. Each pressure filter system shall be equipped with a pressure gauge at least four inches in diameter on the inlet and outlet to indicate the pressure in pounds per square inch, and a sight glass that can be easily removed for cleaning shall be provided on the waste discharge line. Gravity type filters shall be equipped with loss of head gauges.

The filtration rate for diatomaceous earth filters and similar equipment may not exceed 1-1/2 gallons per square foot of filter area with eight hours turn-over of pool volume unless continuous slurry feed is provided, in which case, the rate shall not exceed three gallons per minute per square foot of filter area.

Arrangements or equipment shall be provided for application of filter aid and proper precoating and cleaning of filter elements. All filters shall be capable of being cleaned or backwashed by use of the washwater pump and the manipulation of valves.

History

• Statutory Authority: § 35.1-11 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 3, eff. March 1, 1962; amended, Virginia Register Volume 36, Issue 1, eff. October 17, 2019.

12VAC5-460-220 Rate of flow indicators

When not prescribed by the Virginia Uniform Statewide Building Code (13VAC5-63) in effect at the time of the pool's construction, the recirculation system shall be equipped with a rate of flow indicator reading in gallons per minute. Indicators shall be properly maintained, easily readable, and located so as to indicate both the rate of flow of the effluent from the filter and the rate of backwash in gallons per minute in sand or anthracite coal filters.

History

• Statutory Authority: § 35.1-11 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 3, eff. March 1, 1962; amended, Virginia Register Volume 36, Issue 1, eff. October 17, 2019.

12VAC5-460-230 (Repealed.)

History

• Historical Notes: Derived from VR355-35-05 § 23, eff. March 1, 1962; repealed, Virginia Register Volume 36, Issue 1, eff. October 17, 2019.

12VAC5-460-240 Chemical feeding equipment

Chemicals shall be automatically fed into the water in the recirculation system by mechanically operated, positive chemical feeders or open-type chemical machines. Closed-type solution pots are prohibited.

History

• Statutory Authority: § 35.1-11 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 3, eff. March 1, 1962; amended, Virginia Register Volume 36, Issue 1, eff. October 17, 2019.

12VAC5-460-250 Disinfection equipment

All swimming pools shall be provided with approved chlorine feeding equipment. The chlorinating equipment shall be capable of applying a dose up to 6.0 ppm of chlorine at the rate of recirculation. Chlorine gas feeding equipment and chlorine gas cylinders shall be installed in an enclosed space or room separate from the filter room and equipped with a door capable of being locked. When this chlorinator room is tight, it shall be equipped with a forced draft fan exhausting to the outside from the floor level, and a fresh air inlet shall be provided near the ceiling. Forced draft apparatus shall have sufficient capacity to exhaust the contents of the room in at least three minutes. The chlorine gas tanks shall be protected from direct sunlight and fastened in place during storage and use. An approved type gas mask shall be provided where chlorine gas is being utilized. Gas masks shall be located accessible to, but outside of, the chlorinator room.

Nothing in this section shall be construed as debarring any other method of disinfection or filtration equipment demonstrated to be of at least equal efficiency and approved by the State Health Commissioner.

History

• Statutory Authority: § 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 25, eff. March 1, 1962.

12VAC5-460-260 Chemical testing equipment

Each swimming pool shall be provided with satisfactory equipment for the determination of hydrogen-ion concentration (pH) ranging from 6.8 to 8.0. Satisfactory equipment shall also be provided for the determination of residual chlorine content ranging from 0.0 to 1.0.

History

• Statutory Authority: § 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 26, eff. March 1, 1962.

12VAC5-460-270 Operating records

Acceptable records of the operation of the swimming pool shall be maintained. These records shall include pH levels, free chlorine residual, water clarity, cleanliness, and such other things as may be required for the health and safety of the bathers. These records shall be kept on file for a period of one year.

History

• Statutory Authority: § 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 27, eff. March 1, 1962.

12VAC5-460-280 Disinfection

The chlorination equipment shall be operated so as to maintain a free chlorine residual content of not less than 0.5 ppm at all points throughout the swimming pool water when there are bathers present.

History

• Statutory Authority: § 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 28, eff. March 1, 1962.

12VAC5-460-290 Alkalinity

The hydrogen-ion concentration should be maintained at 7.2 or above.

History

• Statutory Authority: § 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 29, eff. March 1, 1962.

12VAC5-460-300 Filtration; water clarity

The filters should be operated 24 hours per day during the season of use of the swimming pool. At all times when the pool is open for use, the water shall be sufficiently clear to permit a disc six inches in diameter, divided into alternate black and white quadrants, when placed on the bottom of the pool at the deepest point, to be clearly visible from the swimming pool deck at all distances up to ten yards in a horizontal direction from the projection of the disc on the swimming pool surface.

Chemicals other than chlorine, sodium or calcium hypochlorite, lime, soda ash, and aluminum sulfate shall not be used to treat swimming pool water without permission.

History

• Statutory Authority: § 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 30, eff. March 1, 1962.

12VAC5-460-310 Filter room placards

A placard shall be prominently displayed showing the following data: (i) size of the swimming pool in feet and volume in gallons; (ii) capacity of the filters in square feet and gallons per minute; (iii) capacity of the pumps in gallons per minute at the appropriate head in feet; (iv) head loss at which the filters should be backwashed; and (v) complete instructions for operating the recirculation and disinfection equipment.

History

• Statutory Authority: § 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 31, eff. March 1, 1962.

12VAC5-460-320 Lifeguards

The management of any transient lodging establishment where a swimming pool has been provided for the use of guests shall designate and have on duty a reliable and competent person as a lifeguard and management shall further provide for the use of this lifeguard, such life saving equipment as may be required depending upon the size and depth of the pool.

History

• Statutory Authority: § 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 31, eff. March 1, 1962.

12VAC5-460-330 Commissioner approval

For any items not specifically covered in this chapter or the Virginia Uniform Statewide Building Code (13VAC5-63), the State Health Commissioner is authorized to require that all swimming pool features function adequately, effectively, and without excessive maintenance and operational difficulties to protect the health and safety of those using swimming pools.

It shall be the duty of the applicant to provide such data, tests, or other adequate proof that the device, material, or product will satisfactorily perform the function for which it is intended before such item shall be approved or accepted for tests.

History

• Statutory Authority: § 35.1-11 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 3, eff. March 1, 1962; amended, Virginia Register Volume 36, Issue 1, eff. October 17, 2019.

12VAC5-460-340 Water supplies, lighting, overflow facilities, inlets and outlets

See 12VAC5-460-40 through 12VAC5-460-150.

History

• Statutory Authority: § 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 33, eff. March 1, 1962.

12VAC5-460-350 Location and slopes

Wading pools shall be located so that drainage from surrounding areas will not wash contamination into pools during rainfall.

History

• Statutory Authority: § 35.1-11 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 3, eff. March 1, 1962; amended, Virginia Register Volume 36, Issue 1, eff. October 17, 2019.

12VAC5-460-360 Deck area

Wading pool decks shall be maintained to have and retain a finish as smooth as possible that is nonslip to bare feet.

History

• Statutory Authority: § 35.1-11 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 3, eff. March 1, 1962; amended, Virginia Register Volume 36, Issue 1, eff. October 17, 2019.

12VAC5-460-370 Protection

When not prescribed by the Virginia Uniform Statewide Building Code (13VAC5-63) in effect at the time of the facility's construction, wading pools and wading areas shall be separated from swimming pools by appropriate protection features.

History

• Statutory Authority: § 35.1-11 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 3, eff. March 1, 1962; amended, Virginia Register Volume 36, Issue 1, eff. October 17, 2019.

12VAC5-460-380 Water circulation systems

The recirculation system of wading pools shall be maintained in working order as designed. When not prescribed by the Virginia Uniform Statewide Building Code (13VAC5-63) in effect at the time of the pool's construction, the recirculation system shall provide a pool volume turn-over rate of once in three hours or less or have properly treated water continuously added at a rate of flow sufficient to replace all of the water in the wading pool once in three hours or less. The overflow water, with this method, shall be continuously discharged to waste.

History

• Statutory Authority: § 35.1-11 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 3, eff. March 1, 1962; amended, Virginia Register Volume 36, Issue 1, eff. October 17, 2019.

12VAC5-460-390 Waste discharge

See 12VAC5-460-120.

History

• Statutory Authority: § 35.1-13 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 38, eff. March 1, 1962.

Part III Spray Pools

12VAC5-460-400 Water supplies

Water sprayed into a pool shall be from an approved supply. Spray heads shall be properly maintained as designed.

History

• Statutory Authority: § 35.1-11 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 3, eff. March 1, 1962; amended, Virginia Register Volume 36, Issue 1, eff. October 17, 2019.

12VAC5-460-410 Materials

Spray pools shall be maintained to have a finish as smooth as possible, but nonslip to bare feet.

History

• Statutory Authority: § 35.1-11 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 3, eff. March 1, 1962; amended, Virginia Register Volume 36, Issue 1, eff. October 17, 2019.

12VAC5-460-420 (Repealed.)

History

• Historical Notes: Derived from VR355-35-05 § 41, eff. March 1, 1962; repealed, Virginia Register Volume 36, Issue 1, eff. October 17, 2019.

12VAC5-460-430 Drains

Drains of spray pools shall be maintained and operated in a manner so that water sprayed into the pool will not pond in the pool bottom.

History

• Statutory Authority: § 35.1-11 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 3, eff. March 1, 1962; amended, Virginia Register Volume 36, Issue 1, eff. October 17, 2019.

12VAC5-460-440 Deck areas

Decks shall be maintained to have and retain a finish as smooth as possible and nonslip to bare feet.

History

• Statutory Authority: § 35.1-11 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-05 § 3, eff. March 1, 1962; amended, Virginia Register Volume 36, Issue 1, eff. October 17, 2019.

Chapter 462 Swimming Pool Regulations Governing the Posting of Water Quality Test Results

Part I Definitions

12VAC5-462-10 Definitions

The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise.

"Agent" means a legally authorized representative of the owner.

"Commissioner" means the State Health Commissioner or his subordinate who has been delegated powers in accordance with 12VAC5-462-40.

"Disinfectant" means the agent that disinfects by inhibiting, neutralizing, or destroying the growth of harmful microorganisms.

"District health department" means a consolidation of local health departments as authorized in § 32.1-31 C of the Code of Virginia.

"Free residual disinfectant" means the amount of measurable chlorine or bromine remaining in the water following disinfection.

"Local health department" means the department established in each city and county in accordance with § 32.1-30 of the Code of Virginia.

"Owner" means any person who owns, leases, or proposes to own or lease a public swimming pool.

"Private residential swimming pool" means any swimming pool or spa located on private residential property under the control of the homeowner or a tenant, the use of which is limited to swimming or bathing by members of the homeowner's or tenant's family or their invited guests.

"Public swimming pool" means any swimming pool or spa, other than a private residential swimming pool or spa, intended to be used collectively by numbers of persons for swimming or bathing and operated by any person, whether as owner, lessee, operator or concessionaire, regardless of whether a fee is charged for such use. The term "Public swimming pool" includes, but is not limited to, tourist establishment pools, pools owned or operated by a condominium, private club or association of persons, apartment, or any association of persons. The term "public swimming pool" shall not include single occupant tanks and showers used exclusively for therapeutic purposes.

"Spa" means a hydrotherapy unit designed for recreational or therapeutic use which is not drained, cleaned, or refilled after each use. It may include, but is not limited to, units designed for hydro-jet circulation, hot water, cold water, mineral bath, air induction bubbles, or any combination thereof. Common terminology for a spa includes, but is not limited to, therapeutic pool, hydrotherapy pool, whirlpool, hot spa, and hot tub.

"Swimming pool" or "pool" means any structure, basin chamber, or tank, located either indoors or outdoors, containing an artificial body of water intended to be used for swimming, wading, diving or recreational bathing, including spas and hot tubs, and having a water depth of 24 inches or more at any point.

"Tourist establishment" means any tourist facility such as hotels, motels, bed and breakfast facilities, campgrounds, or summer camps that is regulated by the State Health Department.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.1 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-700 § 1, Virginia Register Volume 10, Issue 20, eff. August 1, 1994.

Part II General Purposes

12VAC5-462-20 Purpose of chapter

This chapter has been promulgated by the State Board of Health to:

1. Ensure that owners or operators of all public swimming pools post daily water quality test results and water quality standards so that users are informed of pool conditions that affect the public health, welfare, and safety.

2. Guide the owner or his agent in the requirements necessary to ensure safe pool maintenance including pH level, disinfectant type and concentration level, and water temperature.

3. Establish the recommended standards for the safe and sanitary maintenance of public swimming pools including the safe levels for: pH, chlorine, bromine, and water temperature for spas.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.1 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-700 § 2.1, Virginia Register Volume 10, Issue 20, eff. August 1, 1994.

12VAC5-462-30 Relationship to the regulations governing hotels, summer camps, and campgrounds

This chapter is independent of and in addition to the requirements of the regulations governing hotels, summer camps, and campgrounds adopted pursuant to § 35.1-11 of the Code of Virginia. Prior to obtaining a permit to operate a hotel, summer camp, or campground, an applicant must comply with the provisions of this chapter.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.1 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-700 § 2.2, Virginia Register Volume 10, Issue 20, eff. August 1, 1994.

12VAC5-462-40 Administration of chapter

A. The State Board of Health, hereinafter referred to as the board, has the responsibility to promulgate, amend, and repeal regulations necessary to ensure the daily posting of water quality test results and water quality standards at public swimming pools.

B. The State Health Commissioner, hereinafter referred to as the commissioner, is the chief executive officer of the State Department of Health. The commissioner has the authority to act within the scope of regulations promulgated by the board and for the board when it is not in session. The commissioner may delegate his powers under these regulations in writing to any subordinate, with the exception of (i) his power to issue variances under § 32.1-12 of the Code of Virginia and 12VAC5-462-150 and (ii) his power to issue orders under § 32.1-26 of the Code of Virginia and 12VAC5-462-100.

The commissioner has final authority to adjudicate contested case decisions of subordinates delegated powers under this section prior to appeal of such case decisions to the circuit court.

C. The State Department of Health, hereinafter referred to as the department, is designated as the primary agent of the commissioner for the purpose of administering this chapter.

D. The district or local health departments are responsible for implementing and enforcing the regulatory activities required by this chapter.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.1 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-700 § 2.3, Virginia Register Volume 10, Issue 20, eff. August 1, 1994.

12VAC5-462-50 Right of entry and inspections

In accordance with the provisions of § 32.1-25 of the Code of Virginia, the commissioner or his designee shall have the right to enter any property to ensure compliance with these regulations.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.1 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-700 § 2.4, Virginia Register Volume 10, Issue 20, eff. August 1, 1994.

12VAC5-462-60 Exemption

This chapter shall not apply to private residential swimming pools or recreational waters other than public swimming pools.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.1 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-700 § 2.5, Virginia Register Volume 10, Issue 20, eff. August 1, 1994.

Article 1 General

12VAC5-462-70 Compliance with Administrative Process Act

Article 1 General

The provisions of the Virginia Administrative Process Act [§ 9-6.14:1 et seq. of the Code of Virginia] shall govern the promulgation and administration of this chapter and shall be applicable to the issuance and appeal of any case decision under this chapter.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.1 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-700 § 3.1, Virginia Register Volume 10, Issue 20, eff. August 1, 1994.

12VAC5-462-80 Powers and procedures of chapter not exclusive

The commissioner may enforce this chapter through any means lawfully available.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.1 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-700 § 3.2, Virginia Register Volume 10, Issue 20, eff. August 1, 1994.

Article 2 Enforcement of Regulations

12VAC5-462-90 Notice

Article 2 Enforcement of Regulations

Subject to the exceptions below, whenever the commissioner or the district or local health department has reason to believe a violation of any of these regulations has occurred or is occurring, the alleged violator shall be notified. Such notice shall be made in writing, shall be delivered personally or sent by certified mail, shall cite the regulation or regulations that are allegedly being violated, shall state the facts which form the basis for believing the violation has occurred or is occurring, shall include a request for a specific action by the recipient by a specified time and shall state the penalties associated with such violation. When the commissioner deems it necessary, he may initiate criminal prosecution or seek civil relief through mandamus or injunction prior to giving notice.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.1 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-700 § 3.3, Virginia Register Volume 10, Issue 20, eff. August 1, 1994.

12VAC5-462-100 Orders

Pursuant to the authority granted in § 32.1-26 of the Code of Virginia, the commissioner may issue orders to require any owner, or other person, to comply with the provisions of this chapter. The order shall be signed by the commissioner and may require:

1. The immediate cessation and correction of the violation;

2. Appropriate remedial action to ensure that the violation does not recur;

3. The submission of a plan to prevent future violation to the commissioner for review and approval;

4. The submission of an application for a variance; or

5. Any other corrective action deemed necessary for proper compliance with this chapter.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.1 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-700 § 3.4, Virginia Register Volume 10, Issue 20, eff. August 1, 1994.

12VAC5-462-110 Hearing before the issuance of an order

Before the issuance of an order described in 12VAC5-462-100, a hearing must be held, with at least 30 days notice by certified mail to the affected owner or other person of the time, place and purpose thereof. The procedures at the hearing shall be in accordance with 12VAC5-462-230 or 12VAC5-462-240 and with §§ 9-6.14:11through9-6.14:14 of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.1 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-700 § 3.5, Virginia Register Volume 10, Issue 20, eff. August 1, 1994.

12VAC5-462-120 Order; when effective

All orders issued pursuant to 12VAC5-462-100 shall become effective not less than 15 days after mailing a copy thereof by certified mail to the last known address of the owner or person violating this chapter. Violation of an order is a Class 1 misdemeanor. See § 32.1-27 of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.1 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-700 § 3.6, Virginia Register Volume 10, Issue 20, eff. August 1, 1994.

12VAC5-462-130 Compliance with effective orders

The commissioner may enforce all orders. Should any owner or other person fail to comply with any order, the commissioner may:

1. Apply to an appropriate court for an injunction or other legal process to prevent or stop any practice in violation of the order;

2. Commence administrative proceedings to suspend or revoke the operations permit if the public swimming pool is a tourist establishment pool.

3. Request the Attorney General to bring an action for civil penalty, injunction, or other appropriate remedy; or

4. Request the Commonwealth's Attorney to bring a criminal action.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.1 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-700 § 3.7, Virginia Register Volume 10, Issue 20, eff. August 1, 1994.

12VAC5-462-140 Not exclusive means of enforcement

Nothing contained in Article 2 of this part shall be interpreted to require the commissioner to issue an order prior to commencing administrative proceedings or seeking enforcement of any regulations or statute through an injunction, mandamus or criminal prosecution, nor shall anything in this chapter affect the authority of the board or commissioner from issuing an emergency order under § 32.1-13 of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.1 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-700 § 3.8, Virginia Register Volume 10, Issue 20, eff. August 1, 1994.

Article 3 Variances

12VAC5-462-150 Granting a variance

Article 3 Variances

Only the commissioner or the deputy commissioners may grant a variance to this chapter. (See §§ 32.1-12 and 32.1-22 of the Code of Virginia and 12VAC5-462-40.) The commissioner or the deputy commissioners shall follow the appropriate procedures set forth in this article in granting a variance.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.1 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-700 § 3.9, Virginia Register Volume 10, Issue 20, eff. August 1, 1994.

12VAC5-462-160 Requirements for a variance

The commissioner may grant a variance if a thorough investigation reveals that the hardship imposed by this chapter outweighs the benefits that may be received by the public. Further, the granting of such a variance shall not subject the public to unreasonable health risks.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.1 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-700 § 3.1, Virginia Register Volume 10, Issue 20, eff. August 1, 1994.

12VAC5-462-170 Application for a variance

Any owner who seeks a variance shall apply in writing. The application shall be signed by the owner, addressed and sent to the commissioner at the State Department of Health in Richmond. The application shall include:

1. A citation to the regulation from which a variance is requested;

2. The nature and duration of the variance requested;

3. Any relevant analytical results including results of relevant tests conducted pursuant to the requirements of this chapter;

4. Statements or evidence why the public health and welfare would not be degraded if the variance were granted;

5. Suggested conditions that might be imposed on the granting of a variance that would limit the detrimental impact on the public health and welfare;

6. Other information, if any, believed pertinent by the applicant; and

7. Such other information as the district or local health department or commissioner may require.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.1 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-700 § 3.11, Virginia Register Volume 10, Issue 20, eff. August 1, 1994.

12VAC5-462-180 Evaluation of a variance application

A. The commissioner shall act on any variance request submitted pursuant to 12VAC5-462-170 within 60 calendar days of receipt of the request.

B. In the evaluation of a variance application, the commissioner shall consider the following factors:

1. The effect that such a variance would have on informing swimming pool users of water quality test results and water quality standards;

2. The cost and other economic considerations imposed by this requirement;

3. The effect that such a variance would have on protection of the public health, welfare and safety;

4. Such other factors as the commissioner may deem appropriate.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.1 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-700 § 3.12, Virginia Register Volume 10, Issue 20, eff. August 1, 1994.

12VAC5-462-190 Disposition of a variance request

A. The commissioner may deny any application for a variance by sending a denial notice to the applicant by certified mail. The notice shall be in writing and shall state the reasons for the denial.

B. If the commissioner proposes to grant a variance request submitted pursuant to 12VAC5-462-170 the applicant shall be notified in writing of this decision. Such notice shall identify the variance, swimming pool covered, and shall specify the period of time for which the variance will be effective. The effective date of a variance shall be as stated in the variance.

C. No owner may challenge the terms or conditions set forth in the variance after 30 calendar days have elapsed from the effective date of the variance.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.1 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-700 § 3.13, Virginia Register Volume 10, Issue 20, eff. August 1, 1994.

12VAC5-462-200 Posting of variances

All variances granted shall be posted in plain view of swimming pool users.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.1 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-700 § 3.14, Virginia Register Volume 10, Issue 20, eff. August 1, 1994.

12VAC5-462-210 Hearings on disposition of variances

Hearings on denials of an application for a variance or on challenges to the terms and conditions of a granted variance may be held pursuant to 12VAC5-462-230 or 12VAC5-462-240, except that informal hearings under 12VAC5-462-230 shall be held by the commissioner or his designee.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.1 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-700 § 3.15, Virginia Register Volume 10, Issue 20, eff. August 1, 1994.

Article 4 Hearings and Appeals

12VAC5-462-220 Hearing types

Article 4 Hearings and Appeals

Hearings before the commissioner or the commissioner's designees shall include any of the forms described in 12VAC5-462-230 or 123VAC5-462-240 depending on the nature of the controversy and the interests of the parties involved.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.1 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-700 § 3.16, Virginia Register Volume 10, Issue 20, eff. August 1, 1994.

12VAC5-462-230 Informal hearings

An informal hearing is a meeting with a district or local health department with the district or local health director presiding and held in conformance with § 9-6.14:11 of the Code of Virginia. The district or local health department shall consider all evidence presented at the meeting which is relevant to the issue in controversy. Presentation of evidence, however, is entirely voluntary. The district or local health department shall have no subpoena power. No verbatim record need be taken at the informal hearing. The local or district health director shall review the facts presented and based on those facts render a decision. A written copy of the decision and the basis for the decision shall be sent to the appellant within 15 working days of the hearing, unless the parties mutually agree to a later date in order to allow the department to evaluate additional evidence. If the decision is adverse to the interests of the appellant, an aggrieved appellant may request an adjudicatory hearing pursuant to 12VAC5-462-240.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.1 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-700 § 3.17, Virginia Register Volume 10, Issue 20, eff. August 1, 1994.

12VAC5-462-240 Adjudicatory hearing

The adjudicatory hearing is a formal, public adjudicatory proceeding before the commissioner, or a designated hearing officer, and held in conformance with § 9-6.14:12 of the Code of Virginia. An adjudicatory hearing includes the following features:

1. Notice.

Notice which states the time and place and the issues involved in the prospective hearing shall be sent to the owner or other person who is the subject of the hearing. Notice shall be sent by certified mail at least 15 calendar days before the hearing is to take place.

2. Record.

A record of the hearing shall be made by a court reporter. A copy of the transcript of the hearing, if transcribed, will be provided within a reasonable time to any person upon written request and payment of the cost.

3. Evidence.

All interested parties may attend the hearing and submit oral and documentary evidence and rebuttal proofs, expert or otherwise, that are material and relevant to the issues in controversy. The admissibility of evidence shall be determined in accordance with § 9-6.14:12 of the Code of Virginia.

4. Counsel.

All parties may be accompanied by and represented by counsel and are entitled to conduct such cross-examination as may elicit a full and fair disclosure of the facts.

5. Subpoena.

Pursuant to § 9-6.14:13 of the Code of Virginia, the commissioner or hearing officer may issue subpoenas on behalf of himself or any person or owner for the attendance of witnesses and the production of books, papers or maps. Failure to appear or to testify or to produce documents without adequate excuse may be reported by the commissioner to the appropriate circuit court for enforcement.

6. Judgment and final order.

The commissioner may designate a hearing officer to conduct the hearing as provided in §§ 9-6.14:12 and 9-6.14:14.1 of the Code of Virginia, and to make written recommended findings of fact and conclusions of law to be submitted for review and final decision by the commissioner. The final decision of the commissioner shall be reduced to writing and will contain the explicit findings of fact upon which his decision is based. Certified copies of the decision shall be delivered to the owner affected by it. Notice of a decision will be served upon the parties and become a part of the record. Service may be by personal service or certified mail return receipt requested.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.1 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-700 § 3.18, Virginia Register Volume 10, Issue 20, eff. August 1, 1994.

12VAC5-462-250 Request for hearing

A request for an informal hearing shall be made by sending the request in writing to the district or local health department. A request for an adjudicatory hearing shall be made in writing and directed to the commissioner at the State Department of Health in Richmond. Requests for hearings shall cite the reason(s) for the hearing request and shall cite the section(s) of this chapter involved.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.1 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-700 § 3.19, Virginia Register Volume 10, Issue 20, eff. August 1, 1994.

12VAC5-462-260 Hearing as a matter of right

Any owner or other person whose rights, duties, or privileges have been or may be affected by any decision of the board or its subordinates in the administration of this chapter shall have a right to both informal and adjudicatory hearings. The commissioner may require participation in informal and adjudicatory hearings. The commissioner may require participation in an informal hearing before granting the request for a full adjudicatory hearing.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.1 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-700 § 3.2, Virginia Register Volume 10, Issue 20, eff. August 1, 1994.

12VAC5-462-270 Appeals

Any request for hearing on the denial of an application for a variance pursuant to 12VAC5-462-190 must be made in writing and received within 60 days of receipt of the denial notice.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.1 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-700 § 3.21, Virginia Register Volume 10, Issue 20, eff. August 1, 1994.

12VAC5-462-280 Posting of water quality test results and water quality standards

A. The test results and water quality standards shall be posted in a location where it is readily observable by the users of the swimming facility.

B. The test results and water quality standards shall be posted on durable waterproof material.

C. The owner is responsible for meeting the requirements set forth in this chapter.

D. The water quality tests shall be performed and posted at least once daily and as often as necessary to maintain the standards as set forth in this chapter. When more than one test is conducted during an operating day, the most recent test results shall be posted.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.1 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-700 § 4.1, Virginia Register Volume 10, Issue 20, eff. August 1, 1994.

12VAC5-462-290 Water quality standards

Free chlorine and bromine residuals and pH values and temperature shall be continuously maintained within the following ranges:

1. Pools.

| Water Quality Standards | | | | | --- | --- | --- | --- | | Free Residual Disinfectant | Minimum | Maximum | | | | Chlorine | 1.0 ppm | 3.0 ppm | | | Bromine | 2.0 ppm | 4.0 ppm | | pH | 7.2 | 7.8 | | | Temperature | none | 104° Fahrenheit (40° Celsius) (Heated Pools Only) | |

2. Spas.

| Water Quality Standards | | | | | --- | --- | --- | --- | | Free Residual Disinfectant | Minimum | Maximum | | | | Chlorine | 2.0 ppm | 10.0 ppm | | | Bromine | 2.0 ppm | 10.0 ppm | | pH | 7.2 | 7.8 | | | Temperature | none | 104° Fahrenheit (40° Celsius) | |

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.1 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-700 § 4.2, Virginia Register Volume 10, Issue 20, eff. August 1, 1994.

12VAC5-462-300 Test kits

Test kits for the measurement of all required chemistry parameters in this chapter shall be provided and maintained at each public swimming pool. The test kits shall be capable of measuring the disinfectant residuals accurately to within 0.5 ppm.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.1 of the Code of Virginia.
• Historical Notes: Derived from VR355-35-700 § 4.3, Virginia Register Volume 10, Issue 20, eff. August 1, 1994.

Chapter 475 Regulations Implementing the Virginia Donor Registry

Part I Definitions and General Information

12VAC5-475-10 Definitions

The following words and terms when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise:

"Anatomical gift" or "organ donation" means a donation of all or part of a human body to take effect after the donor's death for the purpose of transplantation, therapy, research, or education.

"Board" means the State Board of Health.

"Decedent" means a deceased individual whose body or part is or may be the source of an anatomical gift. The term includes a stillborn infant and, subject to restrictions imposed by law other than the restrictions imposed by the Revised Uniform Anatomical Gift Act (§ 32.1-291.1 et seq. of the Code of Virginia), a fetus.

"Department" means the Virginia Department of Health.

"Designee" means a person designated by an organ procurement organization, eye bank, or tissue bank to identify and determine the suitability of a potential donor.

"Document of gift" means a donor card or other record used to make an anatomical gift. The term includes a statement or symbol made pursuant to § 46.2-342 G of the Code of Virginia on a driver's license, an identification card, or a donor registry.

"DonateLifeVirginia.org" means the official Virginia website that provides information on organ and tissue donation and provides a registration form for registrants to make an anatomical gift in accordance with the Revised Uniform Anatomical Gift Act (§ 32.1-291.1 et seq. of the Code of Virginia).

"Donor" means an individual whose body or part is the subject of an anatomical gift.

"Eye bank" means a person that is licensed, accredited, or regulated under federal or state law to engage in the recovery, screening, testing, processing, storage, or distribution of human eyes or portions of human eyes and that is a member of the Virginia Transplant Council, accredited by the Eye Bank Association of America or the American Association of Tissue Banks and operating in the Commonwealth of Virginia.

"Guardian" means a person appointed by a court to make decisions regarding the support, care, education, health, or welfare of an individual. The term does not include a guardian ad litem, except when the guardian ad litem is authorized by a court to consent to donation.

"Organ procurement organization" means a person designated by the Secretary of the U.S. Department of Health and Human Services as an organ procurement organization that is also a member of the Virginia Transplant Council.

"Part" means an organ, an eye, or tissue of a human being. The term does not include the whole body.

"Procurement" means the recovery of any donated part by a licensed physician or a technician who is qualified in accordance with § 32.1-291.14 of the Code of Virginia.

"Registry" means the Virginia Donor Registry, which shall be created, compiled, operated, maintained, and modified as necessary by the Virginia Transplant Council in accordance with § 32.1-292.2 of the Code of Virginia.

"Tissue bank" means a person that is licensed, accredited, or regulated under federal or state law to engage in the recovery, screening, testing, processing, storage, or distribution of tissue, and that is a member of the Virginia Transplant Council, accredited by the American Association of Tissue Banks, and operating in the Commonwealth of Virginia.

"VTC" means the Virginia Transplant Council.

History

• Statutory Authority: § 32.1-292.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 12, eff. March 27, 2002; amended, Virginia Register Volume 31, Issue 22, eff. July 31, 2015.

12VAC5-475-20 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 12, eff. March 27, 2002; repealed, Virginia Register Volume 31, Issue 22, eff. July 31, 2015.

12VAC5-475-30 Administration

A. The VTC, as authorized by the board pursuant to § 32.1-292.2 D 2 of the Code of Virginia, shall analyze registry data under research protocols directed toward determination and identification of means to promote and increase organ, eye, and tissue donation within the Commonwealth.

B. All persons responsible for the administration of the Virginia Donor Registry shall ensure that the registry and all information therein shall be confidential in accordance with §§ 32.1-127.1:03 and 32.1-292.2 B of the Code of Virginia and other applicable state and federal law.

C. The VTC shall maintain and report annually the following information to the board: (i) the number of unique individuals registered in the registry; (ii) the number of recovered organ donors; (iii) the number or recovered organ donors who were identified through the registry; (iv) the number of recovered tissue donors; (v) the number of recovered tissue donors who were identified through the registry; (vi) the number of recovered eye/cornea donors; and (vii) the number of recovered eye/cornea donors identified through the registry. This report shall be made on or before September 30 of each year and contain information pertaining to the previous fiscal year.

History

• Statutory Authority: § 32.1-292.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 12, eff. March 27, 2002; amended, Virginia Register Volume 31, Issue 22, eff. July 31, 2015.

12VAC5-475-40 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 12, eff. March 27, 2002; repealed, Virginia Register Volume 31, Issue 22, eff. July 31, 2015.

Part II Registry Information

12VAC5-475-50 Registry membership

The registry shall record anatomical gifts made in accordance with the Revised Uniform Anatomical Gift Act (§ 32.1-291.1 et seq. of the Code of Virginia). Designees may assist individuals to complete a signed donor registration form.

Those persons who have designated an anatomical gift on their driver's license or personal identification card as authorized by the Department of Motor Vehicles will be automatically entered into the registry. Through interagency agreement, the Department of Motor Vehicles will assist the department by electronically providing this information to the registry on a regular basis as agreed upon by the Department of Motor Vehicles and the VTC. Persons who make an anatomical gift by completing the donor registration form available on the DonateLifeVirginia.org website will also be automatically entered into the registry.

History

• Statutory Authority: § 32.1-292.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 12, eff. March 27, 2002; amended, Virginia Register Volume 31, Issue 22, eff. July 31, 2015.

12VAC5-475-60 Data to be recorded

The following information shall be recorded in the registry: the donor's full name, address (including county or independent city of residence with zip code), date of birth, age, sex, race, and driver's license number or unique identification number. If the donor is under the age of 18, the name, address, and unique identification number of the donor's parent or legal guardian shall be recorded.

History

• Statutory Authority: § 32.1-292.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 12, eff. March 27, 2002; amended, Virginia Register Volume 31, Issue 22, eff. July 31, 2015.

12VAC5-475-70 Removal from the registry

A. A person who has joined the registry may amend his anatomical gift or revoke the anatomical gift by filing an appropriate form with the VTC in accordance with the Revised Uniform Anatomical Gift Act (§ 32.1-291.1 et seq. of the Code of Virginia) or subsection I of § 46.2-342 of the Code of Virginia.

B. Persons who revoke an anatomical gift shall be automatically removed from the registry by the VTC.

C. Persons can revoke an anatomical gift by completing any of the following actions:

1. Notifying the VTC in writing using an appropriate form provided by the VTC, which shall result in being removed from the registry upon receipt of notification by the VTC;

2. Completing the form available on the DonateLifeVirginia.org website, which shall result in immediate removal from the registry by the VTC; or

3. Not renewing an anatomical gift when renewing or replacing a driver's license or personal identification card at the Department of Motor Vehicles, which will result in being removed from the registry within 24 hours of receipt of notification to the VTC from the Department of Motor Vehicles.

D. The name of a person entered in the registry who has died shall be removed from the registry within 90 days of notification of death by the Virginia Division of Vital Records and Health Statistics.

History

• Statutory Authority: § 32.1-292.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 12, eff. March 27, 2002; amended, Virginia Register Volume 31, Issue 22, eff. July 31, 2015.

Part III Access, Use, and Dissemination of Registry Information

12VAC5-475-75 Access

A. Except as otherwise provided by law, no person shall have access to the registry except as provided in this section.

B. Designees shall have access to the registry for the purpose of creating, amending, or revoking the registrant's anatomical gift.

C. The registry and all information therein shall be accessible 24 hours a day and only to specific designees of organ procurement organizations, eye banks, and tissue banks for the purpose of identifying a potential donor according to the provisions of §§ 32.1-127 and 32.1-292.2 of the Code of Virginia. The name of such designees shall be provided to the VTC. If at any time the designee is unable to carry out his responsibilities with respect to the registry, a replacement shall be selected and the VTC shall be notified of such replacement.

D. Persons who require access to the registry for operational and maintenance purposes shall have access to the registry upon receipt from VTC of appropriate access privileges.

E. The department shall be provided access to the registry for the purpose of exercising responsibility for oversight of VTC activities. The department shall not have access to personal information of registrants unless such access is required for the department's oversight responsibilities.

History

• Statutory Authority: § 32.1-292.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 31, Issue 22, eff. July 31, 2015.

12VAC5-475-80 Use

The designees of organ procurement organizations, eye banks, and tissue banks and all other persons with authorized access to the registry shall have an organizational or individual pass code, or both, assigned by the VTC to gain entry to the registry via the website.

Once entry to the registry has been established, the designees shall enter the decedent's full name, date of birth, driver's license number, unique identification number, or any combination thereof, to verify whether the decedent made a donor designation in the registry. Once the decedent's donor designation has been verified, the designees shall include the document of gift as part of the donor record maintained by the organ procurement organization, eye bank, and tissue bank.

If the decedent is not in the registry, the designees shall exit the registry.

History

• Statutory Authority: § 32.1-292.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 12, eff. March 27, 2002; amended, Virginia Register Volume 31, Issue 22, eff. July 31, 2015.

12VAC5-475-90 Dissemination

The organ procurement organizations, eye banks, and tissue banks with authorized access to the registry may disclose the contents of the decedent's document of gift to the decedent's next of kin, the nearest available relative, a member of the decedent's household, an individual with an affinity relationship, the decedent's physicians, and any other person or entity specified in §§ 32.1-291.9 and 32.1-291.11 of the Code of Virginia, in order to demonstrate that the decedent made an anatomical gift in accordance with the Revised Uniform Anatomical Gift Act (§ 32.1-291.1 et seq. of the Code of Virginia), § 46.2-342 of the Code of Virginia, or an advance directive executed pursuant to the Health Care Decisions Act (§ 54.1-2981 et seq. of the Code of Virginia).

History

• Statutory Authority: § 32.1-292.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 12, eff. March 27, 2002; amended, Virginia Register Volume 31, Issue 22, eff. July 31, 2015.

Chapter 480 Radiation Protection Regulations [Repealed]

Part I Definitions (Repealed)

12VAC5-480-10 (Repealed.)

Historical Notes

Derived from VR355-20-01 § 1.1, eff. July 6, 1988; repealed, Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

Part II General Provisions (Repealed)

12VAC5-480-20 (Repealed.)

Historical Notes

Derived from VR355-20-01 §§ 2.1 to 2.15, eff. July 6, 1988; repealed, Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

Part III Registration of Radiation Machine Facilities (Repealed)

12VAC5-480-170 (Repealed.)

Historical Notes

Derived from VR355-20-01 §§ 3.1 to 3.12, eff. July 6, 1988; repealed, Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

Part IV Licensing of Radioactive Material (Repealed)

12VAC5-480-290 (Repealed.)

Historical Notes

Derived from VR355-20-01 §§ 4.1 to 4.90, eff. July 6, 1988; repealed, Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

Part V Standards for Protection Against Radiation (Repealed)

12VAC5-480-1190 (Repealed.)

Historical Notes

Derived from VR355-20-01 §§ 5.1 to 5.408, eff. July 6, 1988; repealed, Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

Part VI Radiation Safety Requirements for Industrial Radiographic Operations (Repealed)

12VAC5-480-5370 (Repealed.)

Historical Notes

Derived from VR355-20-01 §§ 6.1 to 6.306, eff. July 6, 1988; repealed, Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

Part VII X-rays in the Healing Arts (Repealed)

12VAC5-480-8430 (Repealed.)

Historical Notes

Derived from VR355-20-01 §§ 7.1 to 7.11, eff. July 6, 1988; repealed, Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

Part VIII Use of Sealed Radioactive Sources in the Healing Arts (Repealed)

12VAC5-480-8540 (Repealed.)

Historical Notes

Derived from VR355-20-01 §§ 8.1 to 8.4, eff. July 6, 1988; repealed, Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

Part IX Radiation Safety Requirements for Analytical X-ray Equipment (Repealed)

12VAC5-480-8580 (Repealed.)

Historical Notes

Derived from VR355-20-01 §§ 9.1 to 9.6, eff. July 6, 1988; repealed, Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

Part X Radiation Safety Requirements for Particle Accelerators (Repealed)

12VAC5-480-8640 (Repealed.)

Historical Notes

Derived from VR355-20-01 §§ 10.1 to 10.12, eff. July 6, 1988; repealed, Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

Part XI Notices, Instructions and Reports to Workers: Inspections (Repealed)

12VAC5-480-8760 (Repealed.)

Historical Notes

Derived from VR355-20-01 §§ 11.1 to 11.17, eff. July 6, 1988; repealed, Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

Chapter 481 Virginia Radiation Protection Regulations

Part I General Provisions

12VAC5-481-10 Definitions

The following words and terms as used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"A₁" means the maximum activity of special form radioactive material permitted in a Type A package. This value is listed in Table 1 of 12VAC5-481-3770 F.

"A₂" means the maximum activity of radioactive material, other than special form radioactive material, LSA, and SCO material, permitted in a Type A package. This value is listed in Table 1 of 12VAC5-481-3770 F.

"Absorbed dose" means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray (Gy) and the rad.

"Absorbed dose rate" means absorbed dose per unit time, for machines with timers, or dose monitor unit per unit time for linear accelerators.

"Accelerator" means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of one MeV. For purposes of this definition, "particle accelerator" is an equivalent term.

"Accelerator-produced material" means any material made radioactive by a particle accelerator.

"Access control" means a system for allowing only approved individuals to have unescorted access to the security zone and for ensuring that all other individuals are subject to escorted access.

"Accessible surface" means the external surface of the enclosure or housing of the radiation producing machine as provided by the manufacturer. It also means surface of equipment or of an equipment part that can be easily or accidentally touched by persons without the use of a tool.

"Act" means §§ 32.1-227 through 32.1-238 of the Code of Virginia.

"Active maintenance" means any significant activity needed during the period of institutional control to maintain a reasonable assurance that the performance objectives in 12VAC5-481-2490 and 12VAC5-481-2500 are met. Such active maintenance includes ongoing activities such as the pumping and treatment of water from a disposal unit or one-time measures such as replacement of a disposal unit cover. Active maintenance does not include custodial activities such as repair of fencing, repair or replacement of monitoring equipment, revegetation, minor additions to soil cover, minor repair of disposal unit covers, and general disposal site upkeep such as mowing grass.

"Activity" means the rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel (Bq) and the curie (Ci).

"Acute" means a single radiation dose or chemical exposure event or multiple radiation dose or chemical exposure events occurring within a short time (24 hours or less).

"Address of use" means the building or buildings that are identified on the license and where radioactive material may be produced, prepared, received, used, or stored.

"Adult" means an individual 18 or more years of age.

"Agency" means the Radiological Health Program of the Virginia Department of Health.

"Aggregated" means accessible by the breach of a single physical barrier that would allow access to radioactive material in any form, including any devices that contain the radioactive material, when the total activity equals or exceeds a Category 2 quantity of radioactive material as listed in 12VAC5-481-451.

"Agreement state" means any state with which the NRC or the Atomic Energy Commission has entered into an effective agreement under subsection 274b of the Atomic Energy Act of 1954, as amended (42 USC § 2021(b)).

"Airborne radioactive material" means any radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

"Airborne radioactivity area" means a room, enclosure, or area in which airborne radioactive materials composed wholly or partly of licensed material exist in concentrations:

1. In excess of the derived air concentrations (DACs) specified in Appendix B to 10 CFR Part 20; or

2. To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6% of the annual limit on intake (ALI) or 12 DAC hours.

"Air kerma" or "K" means kerma in air (see definition of "kerma").

"Air kerma rate" or "AKR" means the air kerma per unit time.

"Air-purifying respirator" means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.

"Alert" means events may occur, are in progress, or have occurred that could lead to a release of radioactive material but that the release is not expected to require a response by offsite response organizations to protect persons off site.

"Aluminum equivalent" means the thickness of type 1100 aluminum alloy affording the same attenuation, under specified conditions, as the material in question. The nominal chemical composition of type 100 aluminum is 99.00% minimum aluminum, 0.12% copper.

"Analytical x-ray equipment" means equipment used for x-ray diffraction or fluorescence analysis.

"Analytical x-ray system" means a group of components utilizing x-rays or gamma-rays to determine the elemental composition or to examine the microstructure of materials.

"Annual limit on intake" or "ALI" means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of 0.05 Sv (5 rem) or a committed dose equivalent of 0.5 Sv (50 rem) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in Tables 1 and 2 in Appendix B to 10 CFR Part 20.

"Annual refresher safety training" means a review conducted or provided by the licensee or registrant for its employees on radiation safety aspects of industrial radiography. The review shall include, as a minimum, any results of internal inspections, new procedures or equipment, new or revised regulations, and accidents or errors that have been observed. The review shall also provide opportunities for employees to ask safety questions.

"Annually" means at intervals not to exceed one year.

"ANSI" means the American National Standards Institute.

"Approved individual" means an individual whom the licensee has determined to be trustworthy and reliable for unescorted access in accordance with 12VAC5-481-451 and has completed the training required in 12VAC5-481-451.

"Area of use" means a portion of a physical structure that has been set aside for the purpose of producing, preparing, receiving, using, or storing radioactive material.

"Articulated joint" means a joint between two separate sections of a tabletop that provides the capacity for one of the sections to pivot on the line segment along which the sections join.

"As low as is reasonably achievable" or "ALARA" means making every reasonable effort to maintain exposures to radiation as far below the dose limits in these regulations as is practical, consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed or registered sources of radiation in the public interest.

"Assembler" means any person engaged in the business of assembling, replacing, or installing one or more components into an x-ray system or subsystem. The term includes the owner of an x-ray system or his employee or agent who assembles components into an x-ray system that is subsequently used to provide professional or commercial services.

"Assigned protection factor" or "APF" means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.

"Associate radiation safety officer" means an individual who (i) meets the requirements of 12VAC5-481-1750 and 12VAC5-481-1790 and (ii) is currently identified as an associate radiation safety officer for the types of use of byproduct material for which the individual has been assigned duties and tasks by the radiation safety officer on (a) a specific medical use license issued by the agency, NRC, or another agreement state or (b) a medical use permit issued by a NRC master material licensee.

"Associated equipment" means equipment that is used in conjunction with a radiographic exposure device to make radiographic exposures that drive, guide, or come in contact with the source.

"Atmosphere-supplying respirator" means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied-air respirators (SARs) and self-contained breathing apparatus (SCBA) units.

"Attenuation block" means a block or stack, having dimensions 20 centimeters by 20 centimeters by 3.8 centimeters, of type 1100 aluminum alloy or other materials having equivalent attenuation. The nominal chemical composition of type 100 aluminum is 99.00% minimum aluminum, 0.12% copper.

"Authorized medical physicist" means an individual who:

1. Meets the requirements in 12VAC5-481-1760 and 12VAC5-481-1790; or

2. Is identified as an authorized medical physicist or teletherapy physicist on:

a. A specific medical use license issued by the NRC or another Agreement state;

b. A medical use permit issued by an NRC master material licensee;

c. A permit issued by an NRC or another Agreement state broad scope medical use licensee; or

d. A permit issued by an NRC master material license broad scope medical use permittee.

"Authorized nuclear pharmacist" means a pharmacist who:

1. Meets the requirements in 12VAC5-481-1770 and 12VAC5-481-1790;

2. Is identified as an authorized nuclear pharmacist on:

a. A specific license issued by the NRC or another Agreement state that authorizes medical use or the practice of nuclear pharmacy;

b. A permit issued by an NRC master material licensee that authorizes medical use or the practice of nuclear pharmacy;

c. A permit issued by an NRC or another Agreement state broad scope medical use licensee that authorizes medical use or the practice of nuclear pharmacy; or

d. A permit issued by an NRC master material license broad scope medical use permittee that authorizes medical use or the practice of nuclear pharmacy;

3. Is identified as an authorized nuclear pharmacist by a commercial nuclear pharmacy that has been authorized to identify authorized nuclear pharmacists; or

4. Is designated as an authorized nuclear pharmacist in accordance with 12VAC5-481-440 I 2.

"Authorized user" means a practitioner of the healing arts who:

1. Meets the requirements in 12VAC5-481-1790 and any of the following:

a. 12VAC5-481-1910;

b. 12VAC5-481-1940;

c. 12VAC5-481-1980;

d. 12VAC5-481-1990;

e. 12VAC5-481-2000;

f. 12VAC5-481-2018;

g. 12VAC5-481-2030;

h. 12VAC5-481-2040 A; or

2. Is identified as an authorized user on:

a. A specific license issued by the NRC or another Agreement state that authorizes medical use;

b. A permit issued by an NRC master material licensee that authorizes medical use;

c. A permit issued by an NRC or another Agreement state broad scope medical use licensee that authorizes medical use; or

d. A permit issued by an NRC master material license broad scope medical use permittee that authorizes medical use.

"Automatic exposure control" or "AEC" means a device that automatically controls one or more technique factors in order to obtain, at a preselected location, a required quantity of radiation (includes devices such as phototimers and ion chambers).

"Background investigation" means the investigation conducted by a licensee or applicant to support the determination of trustworthiness and reliability.

"Background radiation" means radiation from cosmic sources, naturally occurring radioactive materials, that have not been technologically enhanced, including radon, except as a decay product of source or special nuclear material, and including global fallout as it exists in the environment from the testing of nuclear explosive devices, or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee or registrant. "Background radiation" does not include sources of radiation from radioactive materials regulated by the agency.

"Barrier" (See "Protective barrier").

"Beam axis" means a line from the source through the centers of the x-ray fields.

"Beam-limiting device" means a device that provides a means to restrict the dimensions of the x-ray field or useful beam.

"Beam monitoring system" means a system designed and installed in the radiation head to detect and measure the radiation present in the useful beam.

"Beam scattering foil" means a thin piece of material (usually metallic) placed in the beam to scatter a beam of electrons in order to provide a more uniform electron distribution in the useful beam.

"Becquerel" or "Bq" means the SI unit of activity. One becquerel is equal to one disintegration or transformation per second (dps or tps).

"Beneficial attribute" means, as used in Part XVI (12VAC5-481-3460 et seq.) of this chapter, the radioactivity of the product necessary to the use of the product.

"Beneficial to the product" (See "Beneficial attribute").

"Bent beam linear accelerator" means a linear accelerator geometry in which the accelerated electron beam must change direction by passing through a bending magnet.

"Bioassay" means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in-vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these regulations, "radiobioassay" is an equivalent term.

"Board" means the State Board of Health.

"Brachytherapy" means a method of radiation therapy in which sealed sources are utilized to deliver a radiation dose at a distance of up to a few centimeters, by surface, intracavitary, or interstitial application.

"Buffer zone" means a portion of the disposal site that is controlled by the licensee and that lies under the disposal units and between the disposal units and the boundary of the site.

"Byproduct material" means:

1. Any radioactive material (except special nuclear material) yielded in, or made radioactive by, exposure to the radiation incident to the process of producing or using special nuclear material;

2. The tailings or wastes produced by the extraction or concentration of uranium or thorium from ore processed primarily for its source material content, including discrete surface wastes resulting from uranium solution extraction processes. Underground ore bodies depleted by these solution extraction operations do not constitute "byproduct material" within this definition;

3. a. Any discrete source of radium-226 that is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; or

b. Any material that:

(1) Has been made radioactive by use of a particle accelerator; and

(2) Is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; and

4. Any discrete source of naturally occurring radioactive material, other than source material, that:

a. The NRC, in consultation with the Administrator of the U.S. Environmental Protection Agency, the U.S. Secretary of Energy, the U.S. Secretary of Homeland Security, and the head of any other appropriate federal agency, determines would pose a threat similar to the threat posed by a discrete source of radium-226 to the public health and safety or the common defense and security; and

b. Before, on, or after August 8, 2005, is extracted or converted after extraction for use in a commercial, medical, or research activity.

"C-arm fluoroscope" means an x-ray system in which the image receptor and x-ray tube housing assembly are connected by a common mechanical support system in order to maintain a desired spatial relationship. This system is designed to allow a change in the projection of the beam through the patient without a change in the position of the patient.

"Cabinet radiography" means industrial radiography conducted in an enclosure or cabinet so shielded that every location on the exterior meets the dose limits for individual members of the public as specified in 12VAC5-481-720.

"Cabinet x-ray system" means an x-ray system with the x-ray tube installed in an enclosure independent of existing architectural structures except the floor on which it may be placed. The cabinet x-ray system is intended to contain at least that portion of a material being irradiated, provide radiation attenuation, and exclude personnel from its interior during generation of radiation. Included are all x-ray systems designed primarily for the inspection of carry-on baggage at airline, railroad, and bus terminals, and in similar facilities. An x-ray tube used within a shielded part of a building, or x-ray equipment that may temporarily or occasionally incorporate portable shielding, is not considered a cabinet x-ray system.

"Calendar quarter" means not less than 12 consecutive weeks nor more than 14 consecutive weeks. The first calendar quarter of each year shall begin in January and subsequent calendar quarters shall be so arranged such that no day is included in more than one calendar quarter and no day in any one year is omitted from inclusion within a calendar quarter. The method observed by the licensee or registrant for determining calendar quarters shall only be changed at the beginning of a year.

"Calibration" means the determination of (i) the response or reading of an instrument relative to a series of known radiation values over the range of the instrument or (ii) the strength of a source of radiation relative to a standard.

"Camera" (See "Radiographic exposure device").

"Carrier" means a person engaged in the transportation of passengers or property by land or water as a common, contract, or private carrier, or by civil aircraft.

"Cassette holder" means a device, other than a spot-film device, that supports or fixes the position of an x-ray film (imaging) cassette during an x-ray exposure.

"Category 1 quantities of radioactive material" or "Category 1" means a quantity of radioactive material meeting or exceeding the Category 1 threshold in Table 1 of 12VAC5-481-451. This is determined by calculating the ratio of the total activity of each radionuclide to the Category 1 threshold for that radionuclide and adding the ratios together. If the sum is equal to or exceeds 1, the quantity would be considered a Category 1 quantity. Category 1 quantities of radioactive material do not include the radioactive material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet.

"Category 2 quantities of radioactive material" or "Category 2" means a quantity of radioactive material meeting or exceeding the Category 2 threshold but less than the Category 1 threshold in Table 1 of 12VAC5-481-451. This is determined by calculating the ratio of the total activity of each radionuclide to the Category 2 threshold for that radionuclide and adding the ratios together. If the sum is equal to or exceeds 1, the quantity would be considered a Category 2 quantity. Category 2 quantities of radioactive material do not include the radioactive material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet.

"Certifiable cabinet x-ray system" means an existing uncertified x-ray system that has been modified to meet the certification requirements specified in 21 CFR 1020.40.

"Certificate holder" means a person who has been issued a certificate of compliance or other package approval by the NRC.

"Certificate of compliance" or "CoC" means the certificate issued by the NRC that approves the design of a package for the transportation of radioactive material.

"Certified cabinet x-ray system" means an x-ray system that has been certified in accordance with 21 CFR 1010.2 as being manufactured and assembled pursuant to the provisions of 21 CFR 1020.40.

"Certified components" means components of x-ray systems that are subject to regulations promulgated under P.L. 90-602, the Radiation Control for Health and Safety Act of 1968 of the Food and Drug Administration.

"Certifying entity" means an independent certifying organization meeting the agency's requirements for documenting applicant's training in topics set forth in 12VAC5-481-1320 or equivalent state or NRC regulations.

"CFR" means Code of Federal Regulations.

"Chelating agent" means amine polycarboxylic acids, hydroxycarboxylic acids, gluconic acid, and polycarboxylic acids.

"Chemical description" means a description of the principal chemical characteristics of a low-level radioactive waste.

"Class" means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: for Class D, Days, of less than 10 days; for Class W, Weeks, from 10 to 100 days; and for Class Y, Years, of greater than 100 days. For purposes of these regulations, "lung class" and "inhalation class" are equivalent terms.

"Closed transport vehicle" means a transport vehicle equipped with a securely attached exterior enclosure that during normal transportation restricts the access of unauthorized persons to the cargo space containing the radioactive material. The enclosure may be either temporary or permanent but shall limit access from top, sides, and ends. In the case of packaged materials, it may be of the "see-through" type.

"cm" means centimeters.

"Coefficient of variation" or "C" means the ratio of the standard deviation to the mean value of a population of observations. It is estimated using the following equation:

where:

s = Standard deviation of the observed values;

X%u0305 = Mean value of observations in sample;

x_i = i_th observation in sample;

n = Number of observations in sample.

"Collective dose" means the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.

"Collimator" means a device used to limit the size, shape, and direction of the primary radiation beam. For industrial radiography it means a radiation shield that is placed on the end of the guide tube or directly onto a radiographic exposure device to restrict the size of the radiation beam when the sealed source is cranked into position to make a radiographic exposure.

"Commencement of construction" means taking any action defined as "construction" or any other activity at the site of a facility subject to the regulations in this chapter that has a reasonable nexus to radiological health and safety.

"Committed dose equivalent" or "H_T,50" means the dose equivalent to organs or tissues of reference (T) that will be received from an intake of radioactive material by an individual during the 50-year period following the intake.

"Committed effective dose equivalent" or "H_E,50" means the sum of the products of the weighting factors (w_T) applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to each of these organs or tissues (H_E,50 = S (w_TH_T,50)).

"Computed tomography" means the production of a tomogram by the acquisition and computer processing of x-ray transmission data.

"Computed tomography dose index" means the integral from -7T to %2B7T of the dose profile along a line perpendicular to the tomographic plane divided by the product of the nominal tomographic section thickness and the number of tomograms produced in a single scan, that is:

where:

z = Position along a line perpendicular to the tomographic plane;

D(z) = Dose at position z;

T = Nominal tomographic section thickness;

n = Number of tomograms produced in a single scan.

This definition assumes that the dose profile is centered around z = 0 and that, for a multiple tomogram system, the scan increment between adjacent scans is nT.

"Computer-readable medium" means that the regulatory agency's computer can transfer the information from the medium into its memory.

"Consignee" means the designated receiver of the shipment of low-level radioactive waste.

"Consignment" means each shipment of a package or groups of packages or load of radioactive material offered by a shipper for transport.

"Consortium" means an association of medical use licensees and a PET radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distributions among its associated members for medical use. The PET radionuclide production facility within the consortium must be located at an educational institution or a federal facility or a medical facility.

"Constraint" means each shipment of a package or groups of packages or load of radioactive material offered by a shipper for transport.

"Constraint" or "dose constraint" means a value above which specified licensee actions are required.

"Construction" means the installation of foundations, or in-place assembly, erection, fabrication, or testing for any structure, system, or component of a facility or activity subject to this chapter. The term "construction" does not include:

1. Changes for temporary use of the land for public recreational purposes;

2. Site exploration, including necessary borings to determine foundation conditions or other preconstruction monitoring to establish background information related to the suitability of the site, the environmental impacts of construction or operation, or the protection of environmental values;

3. Preparation of the site for construction of the facility, including clearing of the site, grading, installation of drainage, erosion and other environmental mitigation measures, and construction of temporary roads and borrow areas;

4. Erection of fences and other access control measures that are not related to the safe use of, or security of, radiological materials subject to this chapter;

5. Excavation;

6. Erection of support buildings (e.g., construction equipment storage sheds, warehouse and shop facilities, utilities, concrete mixing plants, docking and unloading facilities, and office buildings) for use in connection with the construction of the facility;

7. Building of service facilities (e.g., paved roads, parking lots, railroad spurs, exterior utility and lighting systems, potable water systems, sanitary sewerage treatment facilities, and transmission lines);

8. Procurement or fabrication of components or portions of the proposed facility occurring at other than the final, in-place location at the facility; or

9. Taking any other action that has no reasonable nexus to radiological health and safety.

"Contact therapy system" means a therapeutic radiation machine with a short target to skin distance (TSD), usually less than five centimeters.

"Contamination" means, as applicable to Part XIII (12VAC5-481-2950 et seq.) of this chapter, the presence of a radioactive substance on a surface in quantities in excess of 0.4 Bq/cm² (1 x 10^-5 µCi/cm²) for beta and gamma emitters and low toxicity alpha emitters, or 0.04 Bq/cm² (1 x 10^-6 µCi/cm²) for all other alpha emitters.

1. Fixed contamination means contamination that cannot be removed from a surface during normal conditions of transport.

2. Nonfixed contamination means contamination that can be removed from a surface during normal conditions of transport.

"Contrast scale" means the change in the linear attenuation coefficient per CTN relative to water, that is:

where:

µ_x = Linear attenuation coefficient of the material of interest; µ_w = Linear attenuation coefficient of water; = of the material of interest; = of water.

"Control cable" or "drive" means the cable that is connected to the source assembly and used to drive the source to and from the exposure location.

"Control drive mechanism" means a device that enables the source assembly to be moved into and out of the exposure device.

"Control panel" means that part of the x-ray control upon which are mounted the switches, knobs, pushbuttons, and other hardware necessary for manually setting the technique factors.

"Control tube" means a protective sheath for guiding the control cable. The control tube connects the control drive mechanism to the radiographic exposure device.

"Controlled area" means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee for any reason.

"Conventional simulator" means any x-ray system designed to reproduce the geometric conditions of the radiation therapy equipment.

"Conveyance" means:

1. For transport by public highway or rail any transport vehicle or large freight container;

2. For transport by water any vessel, or any hold, compartment, or defined deck area of a vessel including any transport vehicle on board the vessel; and

3. For transport by any aircraft.

"Cooling curve" means the graphical relationship between heat units stored and cooling time.

"Cradle" means either:

1. A removable device that supports and may restrain a patient above an x-ray table; or

2. A device:

a. Whose patient support structure is interposed between the patient and the image receptor during normal use;

b. Which is equipped with means for patient restraint; and

c. Which is capable of rotation about its long (longitudinal) axis.

"Critical group" means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

"Criticality safety index" or "CSI" means the dimensionless number (rounded up to the next tenth) assigned to and placed on the label of a fissile material package, to designate the degree of control of accumulation of packages, overpacks or freight containers containing fissile material during transportation. Determination of the criticality safety index is described in 12VAC5-481-3040, 12VAC5-481-3051, and 10 CFR 71.59. The criticality safety index for an overpack, freight container, consignment, or conveyance containing fissile material packages is the arithmetic sum of the critically safety indices of all the fissile material packages contained within the overpack, freight container, consignment, or conveyance.

"CS" (See "Contrast scale").

"CT" (See "Computed tomography").

"CT conditions of operation" means all selectable parameters governing the operation of a CT x-ray system including, but not limited to, nominal tomographic section thickness, filtration, and the technique factors as defined in these regulations.

"CTDI" (See "Computed tomography dose index").

"CT gantry" means the tube housing assemblies, beam-limiting devices, detectors, and the supporting structures and frames which hold these components.

"CTN" (See "CT number").

"CT number" means the number used to represent the x-ray attenuation associated with each elemental area of the CT image.

where:

k = A constant, a normal value of 1,000 when the Hounsfield scale of CTN is used;

µ_x = Linear attenuation coefficient of the material of interest;

µ_w = Linear attenuation coefficient of water.

"Cumulative air kerma" means the total air kerma accrued from the beginning of an examination or procedure and includes all contribution from fluoroscopic and radiographic irradiation.

"Curie" is a unit of quantity of activity. One curie (Ci) is that quantity of radioactive material that decays at the rate of 3.7E%2B10 disintegrations or transformations per second (dps or tps).

"Custodial agency" means an agency of the government designated to act on behalf of the government owner of the disposal site.

"Declared pregnant woman" means a woman who has voluntarily informed the licensee, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant.

"Decommission" means to remove a facility or site safely from service and reduce residual radioactivity to a level that permits release of the property for unrestricted use and termination of the license or release of the property under restricted conditions and termination of the license.

"Decontamination facility" means a facility operating under a commission or Agreement state license whose principal purpose is decontamination of equipment or materials to accomplish recycle, reuse, or other waste management objectives, and, for purposes of this chapter, is not considered to be a consignee for LLW shipments.

"Dedicated check source" means a radioactive source that is used to assure the constant operation of a radiation detection or measurement device over several months or years. This source may also be used for other purposes.

"Deep dose equivalent" or "H_d," which applies to external whole body exposure, means the dose equivalent at a tissue depth of one centimeter (1000 mg/cm²).

"Demand respirator" means an atmosphere-supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation.

"Department of Energy" means the Department of Energy established by P.L. 95-91, August 4, 1977, 91 Stat. 565, 42 USC § 7101 et seq., to the extent that the Department exercises functions formerly vested in the Atomic Energy Commission, its Chairman, members, officers and components and transferred to the Energy Research and Development Administration and to the Administrator thereof pursuant to §§ 104(b), (c) and (d) of the Energy Reorganization Act of 1974 (P.L. 93-438, October 11, 1974, 88 Stat. 1233 at 1237, 42 USC § 5814, effective January 19, 1975) and retransferred to the U.S. Secretary of Energy pursuant to § 301(a) of the Department of Energy Organization Act (P.L. 95-91, August 4, 1977, 91 Stat. 565 at 577-578, 42 USC § 7151, effective October 1, 1977).

"Depleted uranium" means the source material uranium in which the isotope uranium-235 is less than 0.711 weight percentage of the total uranium present. Depleted uranium does not include special nuclear material.

"Derived air concentration" or "DAC" means the concentration of a given radionuclide in air which, if breathed by the reference man for a working year of 2,000 hours under conditions of light work, results in an intake of one ALI. For purposes of these regulations, the condition of light work is an inhalation rate of 1.2 cubic meters of air per hour for 2,000 hours in a year. DAC values are given in Appendix B to 10 CFR Part 20.

"Derived air concentration-hour" or "DAC hour" means the product of the concentration of radioactive material in air, expressed as a fraction or multiple of the derived air concentration for each radionuclide, and the time of exposure to that radionuclide, in hours. A licensee or registrant may take 2,000 DAC hours to represent one ALI, equivalent to a committed effective dose equivalent of 0.05 Sv (5 rem).

"Detector" (See "Radiation detector").

"Deuterium" means, for the purposes of Part XIII (12VAC5-481-2950 et seq.) of this chapter, deuterium and any deuterium compounds, including heavy water, in which the ratio of deuterium atoms to hydrogen atoms exceeds 1:5000.

"Diagnostic clinical procedures manual" means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures, where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

"Diagnostic source assembly" means the tube housing assembly with a beam-limiting device attached.

"Diagnostic x-ray system" means an x-ray system designed for irradiation of any part of the human or animal body for the purpose of diagnosis or visualization.

"Direct scattered radiation" means that scattered radiation that has been deviated in direction only by materials irradiated by the useful beam (See "Scattered radiation").

"Discrete source" means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.

"Disposable respirator" means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of-service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator and a disposable escape-only self-contained breathing apparatus (SCBA).

"Disposal" means the isolation of wastes from the biosphere inhabited by man and his food chains by emplacement in a land disposal facility.

"Disposal container" means a container principally used to confine low-level radioactive waste during disposal operations at a land disposal facility (also see "high integrity container"). Note that for some shipments, the disposal container may be the transport package.

"Disposal site" means that portion of a land disposal facility that is used for disposal of waste. It consists of disposal units and a buffer zone.

"Disposal unit" means a discrete portion of the disposal site into which waste is placed for disposal. For near-surface disposal, the unit is usually a trench.

"Distinguishable from background" means that the detectable concentration of a radionuclide is statistically different from the background concentration of that radionuclide in the vicinity of the site or, in the case of structures, in similar materials using adequate measurement technology, survey, and statistical techniques.

"Diversion" means the unauthorized movement of radioactive material subject to 12VAC5-481-451 to a location different from the material's authorized destination inside or outside of the site at which the material is used or stored.

"Dose" is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, total organ dose equivalent, or total effective dose equivalent. For purposes of these regulations, "radiation dose" is an equivalent term.

"Dose commitment" means the total radiation dose to a part of the body that will result from retention in the body of radioactive material. For purposes of estimating the dose commitment, it is assumed that from the time of intake the period of exposure to retained material will not exceed 50 years.

"Dose equivalent" or "H_T" means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert (Sv) and rem.

"Dose limits" means the permissible upper bounds of radiation doses established in accordance with these regulations. For purposes of these regulations, "limits" is an equivalent term.

"Dose monitor unit" or "DMU" means a unit response from the beam monitoring system from which the absorbed dose can be calculated.

"Dose profile" means the dose as a function of position along a line.

"Dosimetry processor" means an individual or an organization that processes and evaluates individual monitoring devices in order to determine the radiation dose delivered to the monitoring devices.

"Doubly encapsulated sealed source" means a sealed source in which the radioactive material is sealed within an inner capsule and that capsule is sealed within an outer capsule.

"Drive cable" (See "Control cable").

"Effective dose equivalent" or "H_E" means the sum of the products of the dose equivalent (H_T) to each organ or tissue and the weighting factor (w_T) applicable to each of the body organs or tissues that are irradiated (H_E = S w_TH_T).

"Electronic brachytherapy" means a method of radiation therapy where an electrically generated source of ionizing radiation is placed in or near the tumor or target tissue to deliver therapeutic radiation dosage.

"Electronic brachytherapy device" means the system used to produce and deliver therapeutic radiation including the x-ray tube, the control mechanism, the cooling system, and the power source.

"Electronic brachytherapy source" means the x-ray tube component used in an electronic brachytherapy device.

"Elemental area" means the smallest area within a tomogram for which the x-ray attenuation properties of a body are depicted. (See also "Picture element").

"Embryo/fetus" means the developing human organism from conception until the time of birth.

"Energy compensation source" or "ECS" means a small sealed source, with an activity not exceeding 3.7 MBq (100 µCi), used within a logging tool, or other tool components, to provide a reference standard to maintain the tool's calibration when in use.

"Engineered barrier" means a manmade structure or device that is intended to improve the land disposal facility's ability to meet the performance objectives in these regulations.

"Enriched uranium" (See "Uranium - natural, depleted, enriched").

"Entrance or access point" means any opening through which an individual or extremity of an individual could gain access to radiation areas or to licensed or registered radioactive materials. This includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use.

"EPA identification number" means the number received by a transporter following application to the Administrator of the U.S. Environmental Protection Agency as required by 40 CFR Part 263.

"Equipment" (See "x-ray equipment").

"Escorted access" means accompaniment while in a security zone by an approved individual who maintains continuous direct visual surveillance at all times over an individual who is not approved for unescorted access.

"Exclusive use" means the sole use by a single consignor of a conveyance for which all initial, intermediate, and final loading and unloading are carried out in accordance with the direction of the consignor or consignee. The consignor and the carrier must ensure that any loading or unloading is performed by personnel having radiological training and resources appropriate for safe handling of the consignment. The consignor must issue specific instructions, in writing, for maintenance of exclusive use shipment controls, and include them with the shipping paper information provided to the carrier by the consignor.

"Explosive material" means any chemical compound, mixture, or device that produces a substantial instantaneous release of gas and heat spontaneously or by contact with sparks or flame.

"Exposure" means being exposed to ionizing radiation or to radioactive material.

"Exposure head" means a device that locates the gamma radiography sealed source in the selected working position.

"Exposure rate" means the exposure per unit of time, such as roentgen per minute and milliroentgen per hour.

"External beam radiation therapy" means therapeutic irradiation in which the source of radiation is at a distance from the body.

"External dose" means that portion of the dose equivalent received from any source of radiation outside the body.

"Extremity" means hand, elbow, arm below the elbow, foot, knee, and leg below the knee.

"Facility" means the location, building, vehicle, or complex under one administrative control, at which one or more radiation machines are installed, located or used.

"Fail-safe characteristics" means a design feature that causes beam port shutters to close, or otherwise prevents emergence of the primary beam, upon the failure of a safety or warning device.

"Field emission equipment" means equipment that uses an x-ray tube in which electron emission from the cathode is due solely to the action of an electric field.

"Field-flattening filter" means a filter used to homogenize the absorbed dose rate over the radiation field.

"Field station" means a facility where radioactive sources may be stored or used and from which equipment is dispatched to temporary jobsites.

"Filter" means material placed in the useful beam to preferentially absorb selected radiations. It also means material placed in the useful beam to change beam quality in therapeutic radiation machines subject to Part XV (12VAC5-481-3380 et seq.) of this chapter.

"Filtering facepiece" or "dusk mask" means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.

"Fingerprint orders" means the requirements of 12VAC5-481-451 B or orders issued by the U.S. Nuclear Regulatory Commission or the legally binding requirements issued by Agreement states that require fingerprints and criminal history records checks for individuals with unescorted access to Category 1 and Category 2 quantities of radioactive material or safeguards information-modified handling.

"Fissile material" means the radionuclides uranium-233, uranium-235, plutonium-239, and plutonium-241, or any combination of these radionuclides. "Fissile material" means the fissile nuclides themselves, not material containing fissile nuclides. Unirradiated natural uranium and depleted uranium and natural uranium or depleted uranium, that has been irradiated in thermal reactors only, are not included in this definition. Certain exclusions from fissile material controls are provided in 10 CFR 71.15.

1. Fissile Class I: A package that may be transported in unlimited numbers and in any arrangement, and that requires no nuclear criticality safety controls during transportation. A transport index is not assigned for purposes of nuclear criticality safety but may be required because of external radiation levels.

2. Fissile Class II: A package that may be transported together with other packages in any arrangement but, for criticality control, in numbers that do not exceed an aggregate transport index of 50. These shipments require no other nuclear criticality safety control during transportation. Individual packages may have a transport index not less than 0.1 and not more than 10.

"Fissile material package" means a fissile material packaging together with its fissile material contents.

"Fit factor" means a quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.

"Fit test" means the use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.

"Fluoroscopic imaging assembly" means a subsystem in which x-ray photons produce a set of fluoroscopic images or radiographic images recorded from the fluoroscopic image receptor. It includes the image receptors, electrical interlocks, if any, and structural material providing linkage between the image receptor and diagnostic source assembly.

"Fluoroscopic irradiation time" means the cumulative duration during an examination or procedure of operator-applied continuous pressure to the device, enabling x-ray tube activation in any fluoroscopic mode of operation.

"Fluoroscopy" means a technique for generating x-ray images and presenting them simultaneously and continuously as visible images. This term has the same meaning as the term "radioscopy" in the standards of the International Electrotechnical Commission.

"Focal spot" or "actual" means the area projected on the anode of the x-ray tube bombarded by the electrons accelerated from the cathode and from which the useful beam originates.

"Former Atomic Energy Commission or NRC licensed facilities" means nuclear reactors, nuclear fuel reprocessing plants, uranium enrichment plants, or critical mass experimental facilities where Atomic Energy Commission or NRC licenses have been terminated.

"Gantry" means that part of a radiation therapy system supporting and allowing movements of the radiation head about a center of rotation.

"Generally applicable environmental radiation standards" means standards issued by the U.S. Environmental Protection Agency under the authority of the Atomic Energy Act of 1954, as amended, (42 USC § 2011 et seq.) that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.

"General environment" means, as used in Part XVI (12VAC5-481-3460 et seq.) of this chapter, the total terrestrial, atmospheric, and aquatic environments outside the site boundary within which any activity, operation, or process authorized by a general or specific license issued under Part XVI, is performed.

"General purpose radiographic x-ray system" means any radiographic x-ray system that, by design, is not limited to radiographic examination of specific anatomical regions.

"Generator" means a licensee who (i) is a waste generator as defined in this chapter, or (ii) is the licensee to whom waste can be attributed within the context of the Low-Level Radioactive Waste Policy Amendments Act of 1985 (42 USC § 2021) (e.g., waste generated as a result of decontamination or recycle activities).

"Gonad shield" means a protective barrier for the testes or ovaries.

"Gray" or "Gy" means the SI unit of absorbed dose. One gray is equal to an absorbed dose of one joule per kilogram (100 rad).

"Guide tube (protection sheath)" means a flexible or rigid tube, or "J" tube, for guiding the source assembly and the attached control cable from the exposure device to the exposure head. The guide tube may also include the connections necessary for attachment to the exposure device and to the exposure head.

"Half-value layer" or "HVL" means the thickness of a specified material that attenuates the beam of radiation to an extent that the AKR is reduced by one-half of its original value. In this definition, the contribution of all scattered radiation, other than any which might be present initially in the beam concerned, is deemed to be excluded.

"Hand-held radiographic unit" means x-ray equipment that is designed to be hand-held during operation.

"Hands-on experience" means experience in all of those areas considered to be directly involved in the radiography process, and includes taking radiographs, calibration of survey instruments, operational and performance testing of survey instruments and devices, film development, posting of radiation areas, transportation of radiography equipment, posting of records and radiation area surveillance, etc., as applicable. Excessive time spent in only one or two of these areas, such as film development or radiation area surveillance, should not be counted toward the 2,000 hours of hands-on experience required for a radiation safety officer in 12VAC5-481-1310 B 2 or the hands-on experience for a radiographer as required by 12VAC5-481-1320 A.

"Hazardous waste" means those wastes designated as hazardous by the U.S. Environmental Protection Agency regulations in 40 CFR Part 261.

"Healing arts" means the art or science or group of arts or sciences dealing with the prevention and cure or alleviation of ailments, diseases or infirmities, and has the same meaning as "medicine" when the latter term is used in its comprehensive sense.

"Healing arts screening" means the testing of human beings using x-ray machines for the detection or evaluation of health indications when such tests are not specifically and individually ordered by a licensed practitioner of the healing arts legally authorized to prescribe such x-ray tests for the purpose of diagnosis or treatment.

"Heat unit" means a unit of energy equal to the product of the peak kilovoltage, milliamperes, and seconds, such as (kVp) times (mA) times (seconds).

"Helmet"means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

"High integrity container" or "HIC" means a container commonly designed to meet the structural stability requirements of 12VAC5-481-2572 and to meet U.S. Department of Transportation requirements for a Type A package.

"High radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of one mSv (0.1 rem) in one hour at 30 centimeters from any source of radiation or 30 centimeters from any surface that the radiation penetrates.

"Hood" means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

"Human use" means the internal or external administration of radiation or radioactive material to human beings.

"Hydrogeologic unit" means any soil or rock unit or zone which by virtue of its porosity or permeability, or lack thereof, has a distinct influence on the storage or movement of groundwater.

"Image intensifier" means a device, installed in its housing, that instantaneously converts an x-ray pattern into a corresponding light image of higher intensity.

"Image receptor" means any device, such as a fluorescent screen, radiographic film, x-ray image intensifier tube, solid-state detector, or gaseous detector that transforms incident x-ray photons either into a visible image or into another form that can be made into a visible image by further transformations. In those cases where means are provided to preselect a portion of the image receptor, the term "image receptor" shall mean the preselected portion of the device.

"Image receptor support device" means, for mammographic systems, that part of the system designed to support the image receptor during mammographic examination and to provide a primary protective barrier.

"Inadvertent intruder" means a person who might occupy the disposal site after closure and engage in normal activities, such as agriculture, dwelling construction, or other pursuits in which an individual might be unknowingly exposed to radiation from the waste.

"Indian tribe" means an Indian or Alaska Native tribe, band, nation, pueblo, village, or community that the U.S. Secretary of the Interior acknowledges to exist as an Indian tribe pursuant to the Federally Recognized Indian Tribe List Act of 1994 (25 USC § 479a).

"Independent certifying organization" means an independent organization that meets the agency's criteria for documenting applicant's training in topics set forth in 12VAC5-481-1320 or equivalent Agreement state or NRC regulations.

"Individual" means any human being.

"Individual monitoring" means the assessment of:

1. Dose equivalent (i) by the use of individual monitoring devices or (ii) by the use of survey data; or

2. Committed effective dose equivalent (i) by bioassay or (ii) by determination of the time-weighted air concentrations to which an individual has been exposed, that is, DAC hours. (See the definition of DAC).

"Individual monitoring devices" means devices designed to be worn by a single individual for the assessment of dose equivalent. For purposes of these regulations, "personnel dosimeter" and "dosimeter" are equivalent terms. Examples of individual monitoring devices are film badges, thermoluminescent dosimeters (TLDs), pocket ionization chambers, optically stimulated luminescence (OSL) dosimeters and personal air sampling devices.

"Industrial radiography" means an examination of the structure of materials by the nondestructive method of utilizing ionizing radiation to make radiographic images.

"Inhalation class" (See "Class").

"Injection tool" means a device used for controlled subsurface injection of radioactive tracer material.

"Inspection" means an official examination or observation including, but not limited to, tests, surveys, and monitoring to determine compliance with rules, regulations, orders, requirements, and conditions of the agency.

"Institutional controls" means: (i) permanent markers placed at a disposal site, (ii) public records and archives, (iii) government ownership and regulations regarding land or resource use, and (iv) other methods of preserving knowledge about the location, design, and contents of a disposal system.

"Instrument traceability" (for ionizing radiation measurements) means the ability to show that an instrument has been calibrated at specified time intervals using a national standard or a transfer standard. If a transfer standard is used, the calibration must be at a laboratory accredited by a program that requires continuing participation in measurement quality assurance with the National Institute of Standards and Technology or other equivalent national or international program.

"Intensity modulated radiation therapy" or "IMRT" means radiation therapy that uses nonuniform radiation beam intensities that have been determined by various computer-based optimization techniques.

"Interlock" means a device arranged or connected such that the occurrence of an event or condition is required before a second event or condition can occur or continue to occur.

"Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.

"Interruption of irradiation" means the stopping of irradiation with the possibility of continuing irradiation without resetting of operating conditions at the control panel.

"Intruder barrier" means a sufficient depth of cover over the waste that inhibits contact with waste and helps to ensure that radiation exposures to an inadvertent intruder will meet the performance objectives set forth in these regulations, or engineered structures that provide equivalent protection to the inadvertent intruder.

"Irradiation" means the exposure of matter to ionizing radiation.

"Irradiator" means a facility that uses radioactive sealed sources for the irradiation of objects or materials and in which radiation dose rates exceeding five grays (500 rads) per hour exist at one meter from the sealed radioactive sources in air or water, as applicable for the irradiator type, but does not include irradiators in which both the sealed source and the area subject to irradiation are contained within a device and are not accessible to personnel.

"Irradiator operator" means an individual who has successfully completed the training and testing described in 12VAC5-481-2830 and is authorized by the terms of the license to operate the irradiator without a supervisor present.

"Irradiator operator supervisor" means an individual who meets the requirements for an irradiator operator and who physically oversees operation of the irradiator by an individual who is currently receiving training and testing described in 12VAC5-481-2830.

"Isocenter" means the center of the smallest sphere through which the beam axis passes when the equipment moves through a full range of rotations about its common center.

"kBq" means kilobecquerel.

"Kerma" or "K" means the quantity defined by the International Commission on Radiation Units and Measurements. The kerma is the quotient of dEtr by dm, where dEtr is the sum of the initial kinetic energies of all charged particles liberated by uncharged particles in a mass dm of materials; thus K=dEtr/dm, in units of J/kg, where the special name for the units of kerma is gray (Gy). When the materials is air, the quantity is referred to as "air kerma."

"Kilovolt" or "kV" means the energy equal to that acquired by a particle with one electron charge in passing through a potential difference of 1,000 volts in a vacuum. Current convention is to use kV for photons and keV for electrons.

"Kilovolts peak" (See "Peak tube potential").

"kV" means kilovolts.

"kVp" (See "Peak tube potential").

"kWs" means kilowatt second.

"Land disposal facility" means the land, buildings, structures and equipment that are intended to be used for the disposal of wastes into the subsurface of the land. For purposes of this chapter, a "geologic repository" as defined in 10 CFR Part 60 or 10 CFR Part 63 is not considered a land disposal facility.

"Last image hold radiograph" or "LIH" means an image obtained either by retaining one or more fluoroscopic images, which may be temporarily integrated, at the end of a fluoroscopic exposure or by initiating a separate and distinct radiographic exposure automatically and immediately in conjunction with termination of the fluoroscopic exposure.

"Lay-barge radiography" means industrial radiography performed on any water vessel used for laying pipe.

"Lead equivalent" means the thickness of the material in question affording the same attenuation, under specified conditions, as lead.

"Leakage radiation" means radiation emanating from the diagnostic source assembly or the radiation therapy system except for:

1. The useful beam; and

2. Radiation produced when the exposure switch or timer is not activated.

"Leakage technique factors" means the technique factors associated with the diagnostic source assembly that are used in measuring leakage radiation. They are defined as follows:

1. For diagnostic source assemblies intended for capacitor energy storage equipment, the maximum-rated peak tube potential and the maximum-rated number of exposures in an hour for operation at the maximum-rated peak tube potential with the quantity of charge per exposure being 10 millicoulombs, (10 mAs), or the minimum obtainable from the unit, whichever is larger;

2. For diagnostic source assemblies intended for field emission equipment rated for pulsed operation, the maximum-rated peak tube potential and the maximum-rated number of x-ray pulses in an hour for operation at the maximum-rated peak tube potential; or

3. For all other diagnostic source assemblies, the maximum-rated peak tube potential and the maximum-rated continuous tube current for the maximum-rated peak tube potential.

"Lens dose equivalent" or "LDE" applies to the external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 cm (300 mg/cm²).

"License" means a license issued by the agency in accordance with the regulations adopted by the board.

"Licensed material" means radioactive material received, possessed, used, transferred or disposed of under a general or specific license issued by the agency.

"Licensee" means any person who is licensed by the agency in accordance with these regulations and the Act.

"Light field" means the area illuminated by light, simulating the radiation field.

"Limits" (See "Dose limits").

"Line-voltage regulation" means the difference between the no-load and the load line potentials expressed as a percent of the load line potential as follows:

Percent line-voltage regulation = 100 (V_n-V_l)/V_l

where:

V_n = No-load line potential; and

V_l = Load line potential.

"Lixiscope" means a portable light-intensified imaging device using a sealed source.

"Local components" means part of an analytical x-ray system and include areas that are struck by x-rays such as radiation source housings, port and shutter assemblies, collimators, sample holders, cameras, goniometers, detectors, and shielding, but do not include power supplies, transformers, amplifiers, readout devices, and control panels.

"Local law-enforcement agency" or "LLEA" means a public or private organization that has been approved by a federal, state, or local government to carry firearms and make arrests, and is authorized and has the capability to provide an armed response in the jurisdiction where the licensed Category 1 or Category 2 quantity of radioactive material is used, stored, or transported.

"Logging assistant" means any individual who, under the personal supervision of a logging supervisor, handles sealed sources or tracers that are not in logging tools or shipping containers or who performs surveys required by Part XIV (12VAC5-481-3140 et seq.) of this chapter.

"Logging supervisor" means the individual who uses licensed material or provides personal supervision in the use of licensed material at a temporary jobsite and who is responsible to the licensee for assuring compliance with the requirements of this chapter and the conditions of the license.

"Logging tool" means a device used subsurface to perform well-logging.

"Loose-fitting facepiece" means a respiratory inlet covering that is designed to form a partial seal with the face.

"Lost or missing licensed material" means licensed (or registered) source of radiation whose location is unknown. This definition includes, but is not limited to, radioactive material that has been shipped but has not reached its planned destination and whose location cannot be readily traced in the transportation system.

"Lot tolerance percent defective" means, expressed in percent defective, the poorest quality in an individual inspection lot that should be accepted.

"Low specific activity material" or "LSA material" means radioactive material with limited specific activity that is nonfissile or is excepted under 12VAC5-481-2970 C, and that satisfies the descriptions and limits set forth below. Shielding materials surrounding the LSA material may not be considered in determining the estimated average specific activity of the package contents. LSA material must be in one of three groups:

1. LSA-I

a. Uranium and thorium ores, concentrates of uranium and thorium ores, and other ores containing naturally occurring radionuclides that are intended to be processed for the use of these radionuclides;

b. Natural uranium, depleted uranium, natural thorium or their compounds or mixtures, provided they are unirradiated and in solid or liquid form;

c. Radioactive material other than fissile material, for which the A₂ value is unlimited; or

d. Other radioactive material in which the activity is distributed throughout and the estimated average specific activity does not exceed 30 times the value for exempt material activity concentration determined in accordance with 12VAC5-481-3720.

2. LSA-II

a. Water with tritium concentration up to 0.8 terabecquerel per liter (20.0 Ci/L); or

b. Other radioactive material in which the activity is distributed throughout and the estimated average specific activity does not exceed 1.0 E-04 A₂/g for solids and gases, and 1.0 E-05 A₂/g for liquids.

3. LSA-III

Solids (e.g., consolidated wastes, activated materials), excluding powders, that satisfy the requirements of 10 CFR 71.77) in which:

a. The radioactive material is distributed throughout a solid or a collection of solid objects, or is essentially uniformly distributed in a solid compact binding agent (e.g., concrete, bitumen, or ceramic);

b. The radioactive material is relatively insoluble, or it is intrinsically contained in a relatively insoluble material, so that, even under loss of packaging, the loss of radioactive material per package by leaching, when placed in water for seven days, would not exceed 0.1 A₂; and

c. The estimated average specific activity of the solid, excluding any shielding material, does not exceed 2.0 E-03 A₂/g.

"Low toxicity alpha emitters" means natural uranium, depleted uranium, natural thorium; uranium-235, uranium-238, thorium-232, thorium-228 or thorium-230 when contained in ores or physical or chemical concentrates or tailings; or alpha emitters with a half-life of less than 10 days.

"Lung class" (See "Class").

"mA" means milliampere.

"mAs" means milliampere second.

"Major processor" means a user processing, handling, or manufacturing radioactive material exceeding Type A quantities as unsealed sources or material, or exceeding four times Type B quantities as sealed sources, but does not include nuclear medicine programs, universities, industrial radiographers, or small industrial programs. Type A and B quantities are defined in this section.

"Management" means the chief executive officer or that individual's designee.

"MBq" means megabecquerels.

"Medical event" means an event that meets the criteria in 12VAC5-481-2080.

"Medical institution" means an organization in which several medical disciplines are practiced.

"Medical use" means the intentional internal or external administration of radioactive material or the radiation from radioactive material to patients or human research subjects under the supervision of an authorized user.

"Megavolt" or "MV" means the energy equal to that acquired by a particle with one electron charge in passing through a potential difference of one million volts in a vacuum. (Note: current convention is to use MV for photons and MeV for electrons.)

"Member of the public" means an individual except when that individual is receiving an occupational dose.

"Mineral logging" means any logging performed for the purpose of mineral exploration other than oil or gas.

"Minor" means an individual less than 18 years of age.

"Misadministration" means either:

1. An x-ray teletherapy radiation dose:

a. Involving the wrong patient;

b. Involving the wrong mode of treatment;

c. Involving the wrong treatment site;

d. Where the calculated total administered dose differs from the total prescribed dose by more than 10% when the treatment consists of three or fewer fractions;

e. Where the calculated weekly administered dose differs from the weekly prescribed dose by 30%; or

f. Where the calculated total administered dose differs from the total prescribed dose by more than 20%; or

2. An x-ray brachytherapy radiation dose:

a. Involving the wrong patient;

b. Involving the wrong treatment site; or

c. Where the calculated administered dose differs from the prescribed dose by more than 20%.

"mm" means millimeters.

"Mobile device" means a piece of equipment containing licensed radioactive materials that is either mounted on wheels or casters, or otherwise equipped for moving without a need for disassembly or dismounting, or designed to be hand carried. Mobile devices do not include stationary equipment installed in a fixed location.

"Mobile electronic brachytherapy service" means transportation of an electronic brachytherapy device to provide electronic brachytherapy at an address that is not the address of record.

"Mobile nuclear medicine service" means the transportation of byproduct material to and its medical use at the client's address.

"Mobile x-ray equipment" (See "x-ray equipment").

"Mode of operation" means, for fluoroscopy systems, a distinct method of fluoroscopy or radiography provided by the manufacturer and selected with a set of several technique factors or other control settings uniquely associated with the mode. The set of distinct technique factors and control settings for the mode may be selected by the operation of a single control. Examples of distinct modes of operation include normal fluoroscopy (analog or digital), high-level control fluoroscopy, cineradiography (analog and digital), digital subtraction angiography, electronic radiography using the fluoroscopic image receptor, and photospot recording. In a specific mode of operation, certain system variables affecting kerma, AKR, or image quality, such as image magnification, x-ray field size, pulse rate, pulse duration, number of pulses, source-image receptor distance (SID), or optical aperture, may be adjustable or may vary; their variation per se does not comprise a mode of operation different from the one that has been selected.

"Monitor unit" or "MU" (See "Dose monitor unit").

"Monitoring" means the measurement of radiation, radioactive material concentrations, surface area activities or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses. For purposes of these regulations, "radiation monitoring" and "radiation protection monitoring" are equivalent terms. For Part XI (12VAC5-481-2330 et seq.) of this chapter, it means observing and making measurements to provide data to evaluate the performance and characteristics of the disposal site.

"Movement control center" means an operation center that is remote from the transport activity and that maintains the position information on the movement of radioactive material, receives reports of attempted attacks or thefts, provides a means for reporting these and other problems to appropriate agencies and can request and coordinate appropriate aid.

"Moving beam radiation therapy" means radiation therapy with any planned displacement of radiation field or patient relative to each other, or with any planned change of absorbed dose distribution. It includes arc, skip, conformal, intensity modulation and rotational therapy.

"Multiple tomogram system" means a computed tomography x-ray system that obtains x-ray transmission data simultaneously during a single scan to produce more than one tomogram.

"NARM" means any naturally occurring or accelerator-produced radioactive material. It does not include byproduct, source, or special nuclear material.

"National Sealed Source and Device Registry" or "SSDR" means the national registry that contains the registration certificates, maintained by the NRC, that summarize the radiation safety information for sealed sources and devices, and describes the licensing and use conditions approved for the product.

"Nationally tracked source" means a sealed source containing a quantity equal to or greater than Category 1 or Category 2 levels of any radioactive material listed in 12VAC5-481-3780. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form and that is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. Category 1 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 1 threshold. Category 2 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 2 threshold but less than the Category 1 threshold.

"Natural radioactivity" means radioactivity of naturally occurring nuclides.

"Natural thorium" means thorium with the naturally occurring distribution of thorium isotopes, which is essentially 100 weight percent thorium-232.

"Natural uranium" (See "Uranium - natural, depleted, enriched").

"Near-surface disposal facility" means a land disposal facility in which waste is disposed of within approximately the upper 30 meters of the earth's surface.

"Negative pressure respirator" or "tight fitting" means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.

"No-later-than arrival time" means the date and time that the shipping licensee and receiving licensee have established as the time at which an investigation will be initiated if the shipment has not arrived at the receiving facility. The no-later-than arrival times may not be more than six hours after the estimated arrival time for shipments of Category 2 quantities of radioactive material.

"Noise" means the standard deviation of the fluctuations in CTN expressed as a percentage of the attenuation coefficient of water. Its estimate (S_n) is calculated using the following expression:

where:

= Linear attenuation coefficient of the material of interest.

µ_w = Linear attenuation coefficient of water.

s = Standard deviation of the CTN of picture elements in a specified area of the CT image.

"Nominal tomographic section thickness" means the full width at half-maximum of the sensitivity profile taken at the center of the cross-sectional volume over which x-ray transmission data are collected.

"Non-image-intensified fluoroscopy" means fluoroscopy using only a fluorescent screen.

"Nonstochastic effect" means a health effect, the severity of which varies with the dose and for which a threshold is believed to exist. Radiation-induced cataract formation is an example of a nonstochastic effect. For purposes of these regulations, "deterministic effect" is an equivalent term.

"NORM" means any naturally occurring radioactive material. It does not include accelerator produced, byproduct, source, or special nuclear material.

"Normal form radioactive material" means radioactive material that has not been demonstrated to qualify as special form radioactive material.

"Normal operating procedures" mean step-by-step instructions necessary to accomplish the analysis. These procedures shall include sample insertion and manipulation, equipment alignment, routine maintenance by the registrant (or licensee), and data recording procedures, which are related to radiation safety.

"Nominal treatment distance" means:

1. For electron irradiation, the distance from the scattering foil, virtual source, or exit window of the electron beam to the entrance surface of the irradiated object along the central axis of the useful beam.

2. For x-ray irradiation, the virtual source or target to isocenter distance along the central axis of the useful beam. For nonisocentric equipment, this distance shall be that specified by the manufacturer.

"NRC Forms 540, 540A, 541, 541A, 542, and 542A" means official NRC forms referenced in this chapter. Licensees need not use originals of these NRC Forms as long as any substitute forms are equivalent to the original documentation in respect to content, clarity, size, and location of information. Upon agreement between the shipper and consignee, NRC Forms 541 (and 541A) and NRC Forms 542 (and 542A) may be completed, transmitted, and stored in electronic media. The electronic media must have the capability for producing legible, accurate, and complete records in the format of the uniform manifest.

"Nuclear Regulatory Commission" or "NRC" means the NRC or its duly authorized representatives.

"Nuclear waste" means a quantity of source, byproduct or special nuclear material (the definition of nuclear waste in this chapter is used in the same way as in 49 CFR 173.403) required to be in NRC-approved specification packaging while transported to, through or across a state boundary to a disposal site, or to a collection point for transport to a disposal site.

"Occupational dose" means the dose received by an individual in the course of employment in which the individual's assigned duties for the licensee or registrant involve exposure to sources of radiation, whether or not the sources of radiation are in the possession of the licensee, registrant, or other person. Occupational dose does not include doses received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with 12VAC5-481-1870, from voluntary participation in medical research programs, or as a member of the public.

"Offshore platform radiography" means industrial radiography conducted from a platform over a body of water.

"Offshore waters" means that area of land and water, beyond the Commonwealth of Virginia's jurisdiction, on or above the U.S. Outer Continental Shelf.

"Open-beam configuration" means an analytical x-ray system in which an individual could accidentally place some part of his body in the primary beam path during normal operation.

"Ophthalmic physicist" means an individual who (i) meets the requirements of 12VAC5-481-1790 and 12VAC5-481-2016 A 2 and (ii) is identified as an ophthalmic physicist on a specific medical use license issued by the agency, NRC, or another agreement state; permit issued by agency, NRC, or another agreement state broad scope licensee; medical use permit issued by a NRC master material licensee; or a permit issued by a NRC master material broad scope medical use permittee.

"Output" means the exposure rate, dose rate, or a quantity related in a known manner to these rates from a teletherapy unit for a specified set of exposure conditions.

"Package" means the packaging together with its radioactive contents as presented for transport.

1. Fissile material package or Type AF package, Type BF package, Type B(U)F package, or Type B(M)F package means a fissile material packaging together with its fissile material contents.

2. Type A package means a Type A packaging together with its radioactive contents. A Type A package is defined and must comply with the DOT regulations in 49 CFR Part 173.

3. Type B package means a Type B packaging together with its radioactive contents. On approval, a Type B package design is designated by NRC as B(U) unless the package has a maximum normal operating pressure of more than 700 kPa (100 lbs/in²) gauge or a pressure relief device that would allow the release of radioactive material to the environment under the tests specified in 10 CFR 71.73 (hypothetical accident conditions), in which case it will receive a designation B(M). B(U) refers to the need for unilateral approval of international shipments; B(M) refers to the need for multilateral approval of international shipments. There is no distinction made in how packages with these designations may be used in domestic transportation. To determine their distinction for international transportation, see DOT regulations in 49 CFR Part 173. A Type B package approved before September 6, 1983, was designated only as Type B. Limitations on its use are specified in 10 CFR 71.19.

"Packaging" means the assembly of components necessary to ensure compliance with the packaging requirements of these regulations. It may consist of one or more receptacles, absorbent materials, spacing structures, thermal insulation, radiation shielding, and devices for cooling or absorbing mechanical shocks. The vehicle, tie-down system, and auxiliary equipment may be designated as part of the packaging.

"Panoramic dry-source-storage irradiator" means an irradiator in which the irradiations occur in air in areas potentially accessible to personnel and in which the sources are stored in shields made of solid materials. The term includes beam-type dry-source-storage irradiators in which only a narrow beam of radiation is produced for performing irradiations.

"Panoramic irradiator" means an irradiator in which the irradiations are done in air in areas potentially accessible to personnel. The term includes beam-type irradiators.

"Panoramic wet-source-storage irradiator" means an irradiator in which the irradiations occur in air in areas potentially accessible to personnel and in which the sources are stored under water in a storage pool.

"Particle accelerator" (See "Accelerator").

"Patient" means an individual or animal subjected to healing arts examination, diagnosis, or treatment.

"PBL" (See "Positive beam limitation").

"Peak tube potential" means the maximum value of the potential difference across the x-ray tube during an exposure.

"Periodic quality assurance check" means a procedure that is performed to ensure that a previous calibration continues to be valid.

"Permanent radiographic installation" means an enclosed shielded room, cell, or vault, not located at a temporary jobsite, in which radiography is performed.

"Person" means any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, department of the Commonwealth other than the Department of Health, political subdivision of the Commonwealth, any other state or political subdivision or department thereof, and any legal successor, representative, agent, or department of the foregoing, but not including federal government agencies.

"Personal supervision" means guidance and instruction by the supervisor who is physically present at the jobsite and watching the performance of the operation in such proximity that contact can be maintained and immediate assistance given as required. In radiography it means guidance and instruction provided to a radiographer trainee by a radiographer instructor who is present at the site, in visual contact with the trainee while the trainee is using sources of radiation, and in such proximity that immediate assistance can be given if required.

"Personnel monitoring equipment" (See "Individual monitoring devices").

"Phantom" means a volume of material behaving in a manner similar to tissue with respect to the attenuation and scattering of radiation. This requires that both the atomic number (Z) and the density of the material be similar to that of tissue.

"Physical description" means the items called for on NRC Form 541 to describe a low-level radioactive waste.

"Pool irradiator" means any irradiator at which the sources are stored or used in a pool of water including panoramic wet-source-storage irradiators and underwater irradiators.

"Pharmacist" means an individual licensed by this state to compound and dispense drugs, prescriptions, and poisons.

"Physician" means an individual licensed by this state to prescribe drugs in the practice of medicine.

"Picture element" means an elemental area of a tomogram.

"PID" (See "Position indicating device").

"Pigtail" (See "Source assembly").

"Pill" (See "Sealed source").

"Planned special exposure" means an infrequent exposure to radiation, separate from and in addition to the annual occupational dose limits.

"Portable x-ray equipment" (See "x-ray equipment").

"Position indicating device" means a device on dental x-ray equipment used to indicate the beam position and to establish a definite source-surface (skin) distance. It may or may not incorporate or serve as a beam-limiting device.

"Positive beam limitation" means the automatic or semi-automatic adjustment of an x-ray beam to the size of the selected image receptor, whereby exposures cannot be made without such adjustment.

"Positron emission tomography radionuclide production facility" or "PET" means a facility operating a cyclotron or other particle accelerator for the purpose of producing radionuclides that decay by positron emission.

"Positive pressure respirator" means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

"Powered air-purifying respirator" or "PAPR" means an air-purifying respirator that uses a blower to force the ambient air through air-purifying elements to the inlet covering.

"Practical examination" means a demonstration through application of the safety rules and principles in industrial radiography including use of all procedures and equipment to be used by radiographic personnel.

"Practical range of electrons" corresponds to classical electron range where the only remaining contribution to dose is from bremsstrahlung x-rays. A further explanation may be found in "Clinical Electron Beam Dosimetry: Report of AAPM Radiation Therapy Committee Task Group 25" (Medical Physics 18(1): 73-109, Jan/Feb. 1991) and ICRU Report 35, "Radiation Dosimetry: Electron Beams with Energies Between 1 and 50 MeV", International Commission on Radiation Units and Measurements, September 15, 1984.

"Preceptor" means an individual who provides, directs, or verifies training and experience required for an individual to become an authorized user, an authorized medical physicist, an authorized nuclear pharmacist, a radiation safety officer, or an associate radiation safety officer.

"Prescribed dosage" means the quantity of radiopharmaceutical activity as documented:

1. In a written directive; or

2. Either in the diagnostic clinical procedures manual or in any appropriate record in accordance with the directions of the authorized user for diagnostic procedures.

"Prescribed dose" means:

1. For gamma stereotactic radiosurgery, the total dose as documented in the written directive;

2. For teletherapy, the total dose and dose per fraction as documented in the written directive. The prescribed dose is an estimation from measured data from a specified therapeutic machine using assumptions that are clinically acceptable for that treatment technique and historically consistent with the clinical calculations previously used for patients treated with the same clinical technique; or

3. For brachytherapy, either the total source strength and exposure time, or the total dose, as documented in the written directive.

"Pressure demand respirator" means a positive pressure atmosphere-supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.

"Primary beam" means radiation that passes through an aperture of the source housing by a direct path from the x-ray tube or a radioactive source located in the radiation source housing.

"Primary dose monitoring system" means a system that will monitor the useful beam during irradiation and that will terminate irradiation when a preselected number of dose monitor units have been delivered.

"Primary protective barrier" means the material, excluding filters, placed in the useful beam to reduce the radiation exposure (beyond the patient and cassette holder) for protection barriers.

"Principal activities," as used in this chapter, means activities authorized by the license that are essential to achieving the purposes for which the license was issued or amended. Storage during which no licensed material is accessed for use or disposal and activities incidental to decontamination or decommissioning are not principal activities.

"Private inspector" means an individual who meets the requirements set forth in 12VAC5-481-340 and who has demonstrated to the satisfaction of the agency that such individual possesses the knowledge, training and experience to measure ionizing radiation, to evaluate safety techniques, and to advise regarding radiation protection needs.

"Product" means, as used in Part XVI (12VAC5-481-3460 et seq.) of this chapter, something produced, made, manufactured, refined, or benefited.

"Product conveyor system" means a system for moving the product to be irradiated to, from, and within the area where irradiation takes place.

"Projection sheath" (See "Guide tube").

"Projector" (See "Radiographic exposure device").

"Protective apron" means an apron made of radiation-attenuating or absorbing materials used to reduce exposure to radiation.

"Protective glove" means a glove made of radiation absorbing materials used to reduce radiation exposure.

"Public dose" means the dose received by a member of the public from exposure to sources of radiation released by the licensee or registrant, or to any other source of radiation under the control of the licensee or registrant. "Public dose" does not include occupational dose, or doses received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with 12VAC5-481-1870, or from voluntary participation in medical research programs.

"Pulsed mode" means operation of the x-ray system such that the x-ray tube is pulsed by the x-ray control to produce one or more exposure intervals of duration less than one-half second.

"Pyrophoric material" means any liquid that ignites spontaneously in dry or moist air at or below 130°F (54.4°C) or any solid material, other than one classed as an explosive, which under normal conditions is liable to cause fires through friction, retained heat from manufacturing or processing, or that can be ignited readily and, when ignited, burns so vigorously and persistently as to create a serious transportation, handling, or disposal hazard. Included are spontaneously combustible and water-reactive materials.

"Qualified inspector" means an individual who is granted professional privileges based on education and experience to provide clinical services in diagnostic and therapeutic medical physics.

"Qualified medical physicist" means an individual qualified in accordance with 12VAC5-481-3390 D.

"Qualitative fit test" or "QLFT" means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual's response to the test agent.

"Quality factor" or "Q" means the modifying factor, that is referenced in 12VAC5-481-240, that is used to derive dose equivalent from absorbed dose.

"Quantitative fit test" or "QNFT" means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

"Quarter" means a period of time equal to one-fourth of the year observed by the licensee, approximately 13 consecutive weeks, providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters.

"Rad" means the special unit of absorbed dose. One rad is equal to an absorbed dose of 100 erg per gram or 0.01 joule per kilogram (0.01 gray).

"Radiation" means alpha particles, beta particles, gamma rays, x-rays, neutrons, high-speed electrons, high-speed protons, and other particles capable of producing ions. For purposes of these regulations, ionizing radiation is an equivalent term. Radiation, as used in these regulations, does not include nonionizing radiation, such as radiowaves or microwaves, visible, infrared, or ultraviolet light.

"Radiation area" means any area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 mSv (0.005 rem) in one hour at 30 centimeters from the source of radiation or from any surface that the radiation penetrates.

"Radiation dose" (See "Dose").

"Radiation field" (See "Useful beam").

"Radiation head" means the structure from which the useful beam emerges.

"Radiation machine" means any device capable of producing radiation except those devices with radioactive material as the only source of radiation.

"Radiation room" means a shielded room in which irradiations take place. Underwater irradiators do not have radiation rooms.

"Radiation safety officer" or "RSO" means an individual who has the knowledge and responsibility to apply appropriate radiation protection regulations and has been assigned such responsibility by the licensee or registrant.

"Radiation safety officer for industrial radiography" means an individual with the responsibility for the overall radiation safety program on behalf of the licensee or registrant and who meets the requirements of 12VAC5-481-1310.

"Radiation safety officer for medical" means an individual who meets the requirements of 12VAC5-481-1750 and 12VAC5-481-1790 or is identified as an RSO on: a medical use license issued by the agency, NRC, or another Agreement state, or a medical use permit issued by an NRC masters material licensee.

"Radiation therapy physicist" means an individual qualified in accordance with 12VAC5-481-340.

"Radiation therapy simulation system" means a radiographic or fluoroscopic x-ray system intended for localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field.

"Radiation therapy system" means a device that delivers radiation to a specific area of the body where cancer cells or tumors are located.

"Radioactive material" means any solid, liquid, or gas which emits radiation spontaneously.

"Radioactive marker" means radioactive material placed subsurface or on a structure intended for subsurface use for the purpose of depth determination or direction orientation.

"Radioactivity" means the transformation of unstable atomic nuclei by the emission of radiation.

"Radiobioassay" (See "Bioassay").

"Radiograph" means an image receptor on which the image is created directly or indirectly by an x-ray pattern and results in a permanent record.

"Radiographer" means any individual who performs or who, in attendance at the site where the sources of radiation are being used, personally supervises industrial radiographic operations and who is responsible to the licensee or registrant for assuring compliance with the requirements of the agency's regulations and the conditions of the license or registration.

"Radiographer certification" means written approval received from a certifying entity stating that an individual has satisfactorily met the radiation safety, testing, and experience criteria in 12VAC5-481-1320.

"Radiographer instructor" means any radiographer who has been authorized by the agency to provide on-the-job training to radiographer trainees in accordance with Part V (12VAC5-481-1170 et seq.) of this chapter.

"Radiographer trainee" means any individual who, under the personal supervision of a radiographer instructor, uses sources of radiation, related handling tools, or radiation survey instruments during the course of his instruction.

"Radiographer's assistant" means any individual who under the direct supervision of a radiographer, uses radiographic exposure devices, sources of radiation, related handling tools, or radiation survey instruments in industrial radiography.

"Radiographic exposure device" means any instrument containing a sealed source fastened or contained therein, in which the sealed source or shielding thereof may be moved, or otherwise changed, from a shielded to unshielded position for purposes of making a radiographic exposure.

"Radiographic operations" means all activities performed with a radiographic exposure device, or with a radiation machine. Activities include using, transporting except by common or contract carriers, or storing at a temporary job site, performing surveys to confirm the adequacy of boundaries, setting up equipment, and any activity inside restricted area boundaries. Transporting a radiation machine is not considered a radiographic operation.

"Radiographic personnel" means any radiographer, radiographer instructor, or radiographer trainee.

"Radiography" means:

1. For radioactive materials: See "Industrial radiography."

2. For x-ray: A technique for generating and recording an x-ray pattern for the purpose of providing the user with an image after termination of the exposure.

"Rating" means the operating limits as specified by the component manufacturer.

"Reasonably maximally exposed individual" means, as used in Part XVI (12VAC5-481-3460 et seq.) of this chapter, a representative of a population who is exposed to TENORM at the maximum TENORM concentration measured in environmental media found at a site along with reasonable maximum case exposure assumptions. The exposure is determined by using maximum values for one or more of the most sensitive parameters affecting exposure, based on cautious but reasonable assumptions, while leaving the others at their mean value.

"Recording" means producing a retrievable form of an image resulting from x-ray photons.

"Redundant beam monitoring system" means a combination of two dose monitoring systems in which each system is designed to terminate irradiation in accordance with a preselected number of dose monitor units.

"Reference man" means a hypothetical aggregation of human physical and physiological characteristics determined by international consensus. These characteristics may be used by researchers and public health employees to standardize results of experiments and to relate biological insult to a common base. A description of the reference man is contained in the International Commission on Radiological Protection report, ICRP Publication 23, "Report of the Task Group on Reference Man."

"Reference plane" means a plane that is displaced from and parallel to the tomographic plane.

"Registrant" means any person who is registered with the agency and is legally obligated to register with the agency pursuant to these regulations and the Act.

"Registration" means registration with the agency in accordance with the regulations adopted by the agency.

"Regulations of the U.S. Department of Transportation" means the regulations in 49 CFR Parts 100 - 189.

"Rem" means the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rems is equal to the absorbed dose in rad multiplied by the quality factor (1 rem = 0.01 Sv).

"Reportable event" means the administration of either:

1. A diagnostic x-ray exposure where an actual or suspected acute or long-term functional damage to an organ or a physiological system has occurred. Exempt from this reporting requirement is any event when any functional damage to a patient organ or a physiological system that was an expected outcome when the causative procedures were prescribed;

2. A procedure where the patient or operator is injured as a result of a mechanical injury;

3. A teletherapy x-ray or electron dose where the calculated weekly administered dose differs from the weekly prescribed dose by 15% or more; or

4. A brachytherapy x-ray dose where the calculated administered dose differs from the prescribed dose by 10% or more.

"Research and development" means (i) theoretical analysis, exploration, or experimentation; or (ii) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstrative purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. Research and development does not include the internal or external administration of radiation or radioactive material to human beings.

"Residential location" means any area where structures in which people lodge or live are located, and the grounds on which such structures are located including, but not limited to, houses, apartments, condominiums, and garages.

"Residual radioactive material" means (i) waste (that the U.S. Secretary of Energy determines to be radioactive) in the form of tailings resulting from the processing of ores for the extraction of uranium and other valuable constituents of the ores and (ii) other waste (that the U.S. Secretary of Energy determines to be radioactive) at a processing site that relates to such processing, including any residual stock of unprocessed ores or low-grade materials. This term is used only with respect to materials at sites subject to remediation under Title I of the Uranium Mill Tailings Radiation Control Act of 1978, as amended.

"Residual radioactivity" means radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the licensee's control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive materials at the site and previous burials at the site, even if those burials were made in accordance with the provisions of Part IV (12VAC5-481-600 et seq.) of this chapter.

"Residual waste" means low-level radioactive waste resulting from processing or decontamination activities that cannot be easily separated into distinct batches attributable to specific waste generators. This waste is attributable to the processor or decontamination facility, as applicable.

"Respiratory protective device" means an apparatus, such as a respirator, used to reduce an individual's intake of airborne radioactive materials.

"Restricted area" means an area, access to which is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to radiation and radioactive materials. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.

"Reviewing official" means the individual who shall make the trustworthiness and reliability determination of an individual to determine whether the individual may have, or continue to have, unescorted access to the Category 1 or Category 2 quantities of radioactive materials that are possessed by the licensee.

"Roentgen" means the special unit of exposure. One roentgen (R) equals 2.58E-4 coulombs per kilogram of air (see "Exposure" and 12VAC5-481-240).

"S-tube" means a tube through which the radioactive source travels when inside a radiographic exposure device.

"Sabotage" means deliberate damage, with malevolent intent, to a Category 1 or Category 2 quantity of radioactive material, a device that contains a Category 1 or Category 2 quantity of radioactive material, or the components of the security system.

"Safe haven" means a readily recognizable and readily accessible site at which security is present or from which, in the event of an emergency, the transport crew can notify and wait for the local law-enforcement authorities.

"Sanitary sewerage" means a system of public sewers for carrying off waste water and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee or registrant.

"Scan" means the complete process of collecting x-ray transmission data for the production of a tomogram. Data can be collected simultaneously during a single scan for the production of one or more tomograms.

"Scan increment" means the amount of relative displacement of the patient with respect to the CT x-ray system between successive scans measured along the direction of such displacement.

"Scan sequence" means a preselected set of two or more scans performed consecutively under preselected CT conditions of operation.

"Scan time" means the period of time between the beginning and end of x-ray transmission data accumulation for a single scan.

"Scattered radiation" means ionizing radiation emitted by interaction of ionizing radiation with matter, the interaction being accompanied by a change in direction of the radiation. Scattered primary radiation means that scattered radiation which has been deviated in direction only by materials irradiated by the useful beam.

"Sealed source" means any radioactive material that is encased in a capsule designed to prevent leakage or escape of any radioactive material.

"Secondary dose monitoring system" means a system which will terminate irradiation in the event of failure of the primary dose monitoring system.

"Security zone" means any temporary or permanent area determined and established by the licensee for the physical protection of Category 1 or Category 2 quantities of radioactive material.

"Seismic area" means any area where the probability of a horizontal acceleration in rock of more than 0.3 times the acceleration of gravity in 250 years is greater than 10%, as designated by the United States Geological Survey.

"Self-contained breathing apparatus" or "SCBA" means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

"Shadow tray" means a device attached to the radiation head to support auxiliary beam blocking material.

"Shallow dose equivalent" or "H_s," which applies to the external exposure of the skin or an extremity, means the dose equivalent at a tissue depth of 0.007 centimeter (7 mg/cm2).

"Shielded position" means the location within the radiographic exposure device or storage container which, by manufacturer's design, is the proper location for storage of the sealed source.

"Shielded-room radiography" means industrial radiography conducted in a room shielded so that radiation levels at every location on the exterior meet the limitations specified in 12VAC5-481-640.

"Shipper" means the licensed entity (i.e., the waste generator, waste collector, or waste processor) who offers low-level radioactive waste for transportation, typically consigning this type of waste to a licensed waste collector, waste processor, or land disposal facility operator.

"Shipping paper" means NRC Form 540 and, if required, NRC Form 540A, which includes the information required by the U.S. Department of Transportation in 49 CFR Part 172.

"Shutter" means a device attached to the tube housing assembly which can intercept the entire cross sectional area of the useful beam and which has a lead equivalency not less than that of the tube housing assembly.

"SI" means the abbreviation for the International System of Units.

"SID" (See "Source-image receptor distance").

"Sievert" or "Sv" means the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sievert is equal to the absorbed dose in gray multiplied by the quality factor (1 Sv = 100 rem).

"Simulator" or "radiation therapy simulation system" means any x-ray system intended for localizing the volume to be exposed during radiation therapy and reproducing the position and size of the therapeutic irradiation field.

"Single tomogram system" means a CT x-ray system that obtains x-ray transmission data during a scan to produce a single tomogram.

"Site area emergency" means events may occur, are in progress, or have occurred that could lead to a significant release of radioactive material and that could require a response by offsite response organizations to protect persons offsite.

"Site boundary" means that line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee.

"Site closure and stabilization" means those actions that are taken upon completion of operations that prepare the disposal site for custodial care and that assure that the disposal site will remain stable and will not need ongoing active maintenance.

"Source" means the focal spot of the x-ray tube.

"Source assembly" means an assembly that consists of the sealed source and a connector that attaches the source to the control cable. The source assembly may include a ballstop to secure the source in the shielded position.

"Source changer" means a device designed and used for replacement of sealed sources in radiographic exposure devices, including those source changers also used for transporting and storage of sealed sources.

"Source holder" means a housing or assembly into which a radioactive source is placed for the purpose of facilitating the handling and use of the source in well-logging operations.

"Source-image receptor distance" means the distance from the source to the center of the input surface of the image receptor.

"Source material" means:

1. Uranium or thorium, or any combination thereof, in any physical or chemical form; or

2. Ores that contain by weight one-twentieth of 1.0% (0.05%) or more of uranium, thorium or any combination of uranium and thorium. Source material does not include special nuclear material.

"Source of radiation" means any radioactive material or any device or equipment emitting, or capable of producing, radiation.

"Source-skin distance" or "SSD" means the distance from the source to the center of the entrant x-ray field in the plane tangent to the patient's skin surface.

"Source traceability" means the ability to show that a radioactive source has been calibrated either by the national standards laboratory of the National Institute of Standards and Technology, or by a laboratory that participates in a continuing measurement quality assurance program with National Institute of Standards and Technology or other equivalent national or international program.

"Special form radioactive material" means radioactive material that satisfies the following conditions:

1. It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;

2. The piece or capsule has at least one dimension not less than five millimeters (0.2 in.); and

3. It satisfies the requirements of 10 CFR 71.75. A special form encapsulation designed in accordance with the NRC requirements of 10 CFR 71.4 in effect on June 30, 1983 (see 10 CFR Part 71, revised as of January 1, 1983), and constructed before July 1, 1985; a special form encapsulation designed in accordance with the requirements of 10 CFR 71.4 in effect on March 31, 1996 (see 10 CFR Part 71, revised as of January 1, 1996), and constructed before April 1, 1998; and special form material that was successfully tested before September 10, 2015, in accordance with the requirements of 10 CFR 71.75(d) in effect before September 10, 2015, may continue to be used. Any other special form encapsulation must meet requirements of this definition.

"Special nuclear material" means:

1. Plutonium, uranium-233, uranium enriched in the isotope 233 or in the isotope 235, and any other material the NRC, pursuant to the provisions of § 51 of the Atomic Energy Act of 1954, as amended, (42 USC § 2071) determines to be special nuclear material, but does not include source material; or

2. Any material artificially enriched by any of the foregoing but does not include source material.

"Special nuclear material in quantities not sufficient to form a critical mass" means uranium enriched in the isotope U-235 in quantities not exceeding 350 grams of contained U-235; uranium-233 in quantities not exceeding 200 grams; plutonium in quantities not exceeding 200 grams; or any combination of them in accordance with the following formula: For each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified above for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed 1. For example, the following quantities in combination would not exceed the limitation and are within the formula:

(175 grams contained U235/350) %2B (50 grams U – 233/200) %2B (50 grams Pu/200) = 1

"Specific activity of a radionuclide" means the radioactivity of a radionuclide per unit mass of that nuclide. The specific activity of a material in which the radionuclide is essentially uniformly distributed is the radioactivity per unit mass of the material.

"Spot film" means a radiograph that is made during a fluoroscopic examination to permanently record conditions that exist during that fluoroscopic procedure.

"Spot-film device" means a device intended to transport or position a radiographic image receptor between the x-ray source and fluoroscopic image receptor. It includes a device intended to hold a cassette over the input end of an image intensifier for the purpose of making a radiograph.

"Stability" means structural stability.

"State inspector" means an employee of the Virginia Department of Health designated to perform those duties or functions assigned the Radiological Health Program.

"Stationary beam radiation therapy" means radiation therapy without displacement of one or more mechanical axes relative to the patient during irradiation.

"Stationary x-ray equipment" (See "x-ray equipment").

"Stochastic effect" means a health effect that occurs randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose without threshold. Hereditary effects and cancer incidence are examples of stochastic effects. For purposes of this chapter, "probabilistic effect" is an equivalent term.

"Storage" means a condition in which a device or source is not being used for an extended period of time, and has been made inoperable.

"Storage area" means any location, facility, or vehicle that is used to store and secure a radiographic exposure device, a radiation machine, or a storage container when it is not used for radiographic operations. Storage areas are locked or have a physical barrier to prevent accidental exposure, tampering, or unauthorized removal of the device, machine, or container.

"Storage container" means a device in which sealed sources or radiation machines are secured and stored.

"Stray radiation" means the sum of leakage and scattered radiation.

"Subsurface tracer study" means the release of a substance tagged with radioactive material for the purpose of tracing the movement or position of the tagged substance in the well-bore or adjacent formation.

"Supplied-air respirator," "airline respirator," or "SAR" means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.

"Surface contaminated object" or "SCO" means a solid object that is not itself classed as radioactive material, but that has radioactive material distributed on any of its surfaces. An SCO must be in one of two groups with surface activity not exceeding the following limits:

1. SCO-I: A solid object on which:

a. The nonfixed contamination on the accessible surface averaged over 300 cm², or the area of the surface if less than 300 cm², does not exceed four becquerel per cm² (1 E-04 µCi/cm²) for beta and gamma and low toxicity alpha emitters, or 0.4 becquerel per cm² (1 E-05 µCi/cm²) for all other alpha emitters;

b. The fixed contamination on the accessible surface averaged over 300 cm², or the area of the surface if less than 300 cm², does not exceed 4x10⁴ becquerel per cm² (1.0 µCi/cm²) for beta and gamma and low toxicity alpha emitters, or 4x10³ becquerel per cm² (0.1 µCi/cm²) for all other alpha emitters; and

c. The nonfixed contamination plus the fixed contamination on the inaccessible surface averaged over 300 cm², or the area of the surface if less than 300 cm², does not exceed 4x10⁴ becquerel per cm² (1 µCi/cm²) for beta and gamma and low toxicity alpha emitters, or 4x10³ Becquerel per cm² (0.1 µCi/cm²) for all other alpha emitters.

2. SCO-II: A solid object on which the limits for SCO-I are exceeded and on which:

a. The nonfixed contamination on the accessible surface averaged over 300 cm², or the area of the surface if less than 300 cm², does not exceed 400 becquerel per cm² (1 E-02 µCi/cm²) for beta and gamma and low toxicity alpha emitters or 40 becquerel per cm² (1 E-03 µCi/cm²) for all other alpha emitters;

b. The fixed contamination on the accessible surface averaged over 300 cm², or the area of the surface if less than 300 cm², does not exceed 8x10⁵ becquerel per cm² (20 µCi/cm²) for beta and gamma and low toxicity alpha emitters, or 8x10⁴ becquerel per cm² (2 µCi/cm²) for all other alpha emitters; and

c. The nonfixed contamination plus the fixed contamination on the inaccessible surface averaged over 300 cm², or the area of the surface if less than 300 cm², does not exceed 8x10⁵ becquerel per cm² (20 µCi/cm²) for beta and gamma and low toxicity alpha emitters, or 8x10⁴ becquerel per cm² (2 µCi/cm²) for all other alpha emitters.

"Surveillance" means monitoring and observation of the disposal site for purposes of visual detection of need for maintenance, custodial care, evidence of intrusion, and compliance with other license and regulatory requirements.

"Survey" means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of radioactive material or other sources of radiation. When appropriate, such an evaluation includes a physical survey of the location of radioactive material and measurements or calculations of levels of radiation, or concentrations or quantities of radioactive material present.

"Tabletop, stationary" means a tabletop that, when assembled for use, is incapable of movement with respect to its supporting structure within the plane of the tabletop.

"Target" means that part of an x-ray tube or accelerator onto which a beam of accelerated particles is directed to produce ionizing radiation or other particles.

"Target-skin distance" or "TSD" means the distance measured along the beam axis from the center of the front surface of the x-ray target or electron virtual source, or both, to the surface of the irradiated object or patient.

"Technologically enhanced naturally occurring radioactive material" or "TENORM" means, as used in Part XVI (12VAC5-481-3460 et seq.) of this chapter, naturally occurring radionuclides whose concentrations are increased by or as a result of past or present human practices. TENORM does not include background radiation or the natural radioactivity of rocks or soils. TENORM does not include uranium or thorium in "source material" as defined in the AEA and NRC regulations.

"Technique factors" means the following conditions of operation:

1. For capacitor energy storage equipment, peak tube potential in kilovolts (kV) and quantity of charge in milliampere-seconds (mAs);

2. For field emission equipment rated for pulsed operation, peak tube potential in kilovolts (kV), and number of x-ray pulses;

3. For CT equipment designed for pulsed operation, peak tube potential in kilovolts (kV), scan time in seconds, and either tube current in milliamperes (mA), x-ray pulse width in seconds, and the number of x-ray pulses per scan, or the product of tube current, x-ray pulse width, and the number of x-ray pulses in milliampere-seconds (mAs);

4. For CT equipment not designed for pulsed operation, peak tube potential in kilovolts (kV), and either tube current in milliamperes (mA) and scan time in seconds, or the product of tube current and exposure time in milliampere-seconds (mAs) and the scan time when the scan time and exposure time are equivalent; and

5. For all other equipment, peak tube potential in kilovolts (kV), and either tube current in milliamperes (mA) and exposure time in seconds, or the product of tube current and exposure time in milliampere-seconds (mAs).

"Telemetric position monitoring system" means a data transfer system that captures information by either instrumentation or measuring devices, or both, about the location and status of a transport vehicle or package between the departure and destination locations.

"Teletherapy physicist" means an individual identified as a qualified teletherapy physicist on an agency license.

"Teletherapy" means therapeutic irradiation in which the source of radiation is at a distance from the body.

"Temporary job site" means any location where industrial radiography, wireline service, well-logging, portable gauge or x-ray fluorescence use is performed and where licensed material may be stored other than those locations of use authorized on the license.

"Tenth-value layer" or "TVL" means the thickness of a specified material that attenuates x-radiation or gamma radiation to an extent such that the air kerma rate, exposure rate, or absorbed dose rate is reduced to one-tenth of the value measured without the material at the same point.

"Test" means the process of verifying compliance with an applicable regulation.

"Therapeutic radiation machine" means x-ray or electron-producing equipment designed and used for external beam radiation therapy. For the purpose of this chapter, devices used to administer electronic brachytherapy shall also be considered therapeutic radiation machines.

"These regulations" mean all parts of this chapter.

"Tight-fitting facepiece" means a respiratory inlet covering that forms a complete seal with the face.

"Tomogram" means the depiction of the x-ray attenuation properties of a section through the body.

"Tomographic plane" means that geometric plane that is identified as corresponding to the output tomogram.

"Tomographic section" means the volume of an object whose x-ray attenuation properties are imaged in a tomogram.

"Total effective dose equivalent" or "TEDE" means the sum of the effective dose equivalent for external exposures and the committed effective dose equivalent for internal exposures.

"Total organ dose equivalent" or "TODE" means the sum of the deep dose equivalent and the committed dose equivalent to the organ receiving the highest dose as described in 12VAC5-481-1040.

"Traceable to a National Standard" (See "Instrument traceability" or "Source traceability").

"Transfer" means, as used in Part XVI (12VAC5-481-3460 et seq.) of this chapter, the physical relocation of NORM containing materials not directly associated with commercial distribution within a business's operation or between general or specific licensees. This term does not include a change in legal title to NORM containing materials that does not involve physical movement of those materials.

"Transport container" means a package that is designed to provide radiation safety and security when sealed sources are transported and that meets all applicable requirements of the U.S. Department of Transportation.

"Transport index" or "TI" means the dimensionless number, rounded up to the next tenth, placed on the label of a package to designate the degree of control to be exercised by the carrier during transportation. The transport index is the number determined by multiplying the maximum radiation level in millisievert (mSv) per hour at one meter (3.3 feet) from the external surface of the package by 100 (equivalent to the maximum radiation level in millirem per hour at one meter (3.3 feet)).

"Treatment site" means the correct anatomical description of the area intended to receive a radiation dose, as described in a written directive.

"Tribal official" means the highest ranking individual that represents tribal leadership, such as the chief, president, or tribal council leadership.

"Tritium neutron generator target source" means a tritium source used within a neutron generator tube to produce neutrons for use in well-logging applications.

"Trustworthiness and reliability" means characteristics of an individual considered dependable in judgment, character, and performance, such that unescorted access to Category 1 or Category 2 quantities of radioactive material by that individual does not constitute an unreasonable risk to the public health and safety or security. A determination of trustworthiness and reliability for this purpose is based upon the results from a background investigation.

"Tube" means an x-ray tube, unless otherwise specified.

"Tube housing assembly" means the tube housing with tube installed. It includes high-voltage or filament transformers and other appropriate elements when such are contained within the tube housing.

"Tube rating chart" means the set of curves which specify the rated limits of operation of the tube in terms of the technique factors.

"Type A quantity" means a quantity of radioactive material, the aggregate radioactivity of which does not exceed A₁ for special form radioactive material or A₂ for normal form radioactive material, where A₁ and A₂ are given in Table 1 of 12VAC5-481-3770 F or may be determined by procedures described in 12VAC5-481-3770 A through E.

"Type B quantity" means a quantity of radioactive material greater than a Type A quantity.

"Underwater irradiator" means an irradiator in which the sources always remain shielded under water and humans do not have access to the sealed sources or the space subject to irradiation without entering the pool.

"Underwater radiography" means radiographic operations performed when the radiographic exposure device or radiation machine or related equipment are beneath the surface of the water.

"Unescorted access" means solitary access to an aggregated Category 1 or Category 2 quantity of radioactive material or the devices that contain the material.

"Uniform Low-Level Radioactive Waste Manifest" or "uniform manifest" means the combination of NRC Forms 540 and 541, and, if necessary, 542, and their respective continuation sheets as needed, or equivalent.

"Unirradiated uranium" means uranium containing not more than 2 x 10³ Bq of plutonium per gram of uranium-235, not more than 9 x 10⁶ Bq of fission products per gram of uranium-235, and not more than 5 x 10^-3 g of uranium-236 per gram of uranium-235.

"Unrefined and unprocessed ore" means ore in its natural form prior to any processing, such as grinding, roasting, beneficiating, or refining. Processing does not include sieving or encapsulating of ore or preparation of samples for laboratory analysis.

"Unrestricted area" means an area, access to which is neither limited nor controlled by the licensee or registrant. For purposes of these regulations, "uncontrolled area" is an equivalent term.

"Uranium - natural, depleted, enriched"

1. "Natural uranium" means uranium (which may be chemically separated) with the naturally occurring distribution of uranium isotopes, which is approximately 0.711 weight percent uranium-235, and the remainder by weight essentially uranium-238.

2. "Depleted uranium" means uranium containing less uranium-235 than the naturally occurring distribution of uranium isotopes.

3. "Enriched uranium" means uranium containing more uranium-235 than the naturally occurring distribution of uranium isotopes.

"Uranium sinker bar" means a weight containing depleted uranium used to pull a logging tool down toward the bottom of a well.

"Useful beam" means the radiation that passes through the tube housing port and the aperture of the beam-limiting device when the exposure switch or timer is activated.

"User seal check" or "fit check" means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check.

"Variable-aperture beam-limiting device" means a beam-limiting device which has capacity for stepless adjustment of the x-ray field size at a given SID.

"Very high radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of five Gy (500 rad) in one hour at one meter from a source of radiation or one meter from any surface that the radiation penetrates.

"Virtual simulator" means a computed tomography (CT) unit used in conjunction with relevant software that recreates the treatment machine and that allows import, manipulation, display, and storage of images from CT or other imaging modalities, or both.

"Virtual source" means a point from which radiation appears to originate.

"Visible area" means that portion of the input surface of the image receptor over which incident x-ray photons are producing a visible image.

"Visiting authorized user" means an authorized user who is not identified on the license of the licensee being visited.

"Waste" means those low-level radioactive wastes containing source, special nuclear, or byproduct material that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in subdivisions 2, 3, and 4 of the definition of byproduct material.

"Waste collector" means an entity, operating under a specific license, whose principal purpose is to collect and consolidate waste generated by others, and to transfer this waste, without processing or repackaging the collected waste, to another licensed waste collector, licensed waste processor, or licensed land disposal facility.

"Waste description" means the physical, chemical and radiological description of a low-level radioactive waste as called for on NRC Form 541.

"Waste generator" means an entity, operating under a license, that (i) possesses any material or component that contains radioactivity or is radioactively contaminated for which the licensee foresees no further use, and (ii) transfers this material or component to a licensed land disposal facility or to a licensed waste collector or processor for handling or treatment prior to disposal. A licensee performing processing or decontamination services may be a "waste generator" if the transfer of low-level radioactive waste from its facility is defined as "residual waste."

"Waste handling licensees" mean persons licensed to receive and store radioactive wastes prior to disposal or persons licensed to dispose of radioactive waste.

"Waste processor" means an entity, operating under a specific license, whose principal purpose is to process, repackage, or otherwise treat low-level radioactive material or waste generated by others prior to eventual transfer of waste to a licensed low-level radioactive waste land disposal facility.

"Waste type" means a waste within a disposal container having a unique physical description (i.e., a specific waste descriptor code or description; or a waste sorbed on or solidified in a specifically defined media).

"Wedge filter" means a filter that effects continuous change in transmission over all or a part of the useful beam.

"Week" means seven consecutive days starting on Sunday.

"Weighting factor" or "w_T" for an organ or tissue (T) means the proportion of the risk of stochastic effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects when the whole body is irradiated uniformly. For calculating the effective dose equivalent, the values of w_T are:

| Organ Dose Weighting Factors | | | --- | --- | | Organ or Tissue | w_T | | Gonads | 0.25 | | Breast | 0.15 | | Red bone marrow | 0.12 | | Lung | 0.12 | | Thyroid | 0.03 | | Bone surfaces | 0.03 | | Remainder | 0.30^a/ | | Whole Body | 1.00^b/ | | ^a/0.30 results from 0.06 for each of five "remainder" organs, excluding the skin and the lens of the eye, that receive the highest doses. | | | ^b/For the purpose of weighting the external whole body dose for adding it to the internal dose, a single weighting factor, w_T = 1.0, has been specified. The use of other weighting factors for external exposure will be approved on a case-by-case basis until such time as specific guidance is issued. | |

"Well-bore" means a drilled hole in which wireline service operations or subsurface tracer studies are performed.

"Well-logging" means all operations involving the lowering and raising of measuring devices or tools that may contain sources of radiation into well-bores or cavities for the purpose of obtaining information about the well or adjacent formations.

"Whole body" means, for purposes of external exposure, head, trunk including male gonads, arms above the elbow, or legs above the knee.

"Wireline" means a cable containing one or more electrical conductors that is used to lower and raise logging tools in the well-bore.

"Wireline service operation" means any evaluation or mechanical service that is performed in the well-bore using devices on a wireline.

"Worker" means an individual engaged in work under a license or registration issued by the agency and controlled by a licensee or registrant but does not include the licensee or registrant.

"Working level" or "WL" means any combination of short-lived radon daughters in one liter of air that will result in the ultimate emission of 1.3x10⁵ MeV of potential alpha particle energy. The short-lived radon daughters of radon-222 are polonium-218, lead-214, bismuth-214, and polonium-214; and those of radon-220 are polonium-216, lead-212, bismuth-212, and polonium-212.

"Working level month" or "WLM" means an exposure to one working level for 170 hours. Two thousand working hours per year divided by 12 months per year is approximately equal to 170 hours per month.

"Written directive" means an authorized user's written order for the administration of radioactive material, radiation from radioactive material, or radiation from a radiation producing machine to a specific patient or human research subject.

"X-ray control" means a device that controls input power to the x-ray high-voltage generator or the x-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers, and similar devices, which control the technique factors of an x-ray exposure.

"X-ray exposure control" means a device, switch, button or other similar means by which an operator initiates or terminates the radiation exposure. The x-ray exposure control may include such associated equipment as timers and back-up timers.

"X-ray equipment" means an x-ray system, subsystem, or component thereof. Types of x-ray equipment are as follows:

1. "Mobile x-ray equipment" means x-ray equipment mounted on a permanent base with wheels or casters for moving while completely assembled.

2. "Portable x-ray equipment" means x-ray equipment designed to be hand-carried.

3. "Stationary x-ray equipment" means x-ray equipment that is installed in a fixed location.

"X-ray field" means that area of the intersection of the useful beam and any one of the sets of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the AKR is one-fourth of the maximum in the intersection.

"X-ray high-voltage generator" means a device that transforms electrical energy from the potential supplied by the x-ray control to the tube operating potential. The device may also include means for transforming alternating current to direct current, filament transformers for the x-ray tubes, high-voltage switches, electrical protective devices, and other appropriate elements.

"X-ray system" means an assemblage of components for the controlled production of x-rays. It includes minimally an x-ray high-voltage generator, an x-ray control, a tube housing assembly, a beam-limiting device, and the necessary supporting structures. Additional components that function with the system are considered integral parts of the system.

"X-ray table" means a patient support device with its patient support structure (tabletop) interposed between the patient and the image receptor during radiography or fluoroscopy. This includes, but is not limited to, any stretcher equipped with a radiolucent panel and any table equipped with a cassette tray (or bucky), cassette tunnel, fluoroscopic image receptor, or spot-film device beneath the tabletop.

"X-ray tube" means any electron tube that is designed for the conversion of electrical energy into x-ray energy.

"Year" means the period of time beginning in January used to determine compliance with the provisions of this chapter. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the change is made at the beginning of the year. If a licensee or registrant changes in a year, the licensee or registrant shall assure that no day is omitted or duplicated in consecutive years.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 25, Issue 2, eff. November 1, 2008; Volume 31, Issue 24, eff. August 27, 2015; Volume 32, Issue 13, eff. March 23, 2016; Volume 32, Issue 24, eff. August 25, 2016; Errata, 33:11 VA.R. 1299 January 23, 2017; amended, Virginia Register Volume 34, Issue 2, eff. October 18, 2017; Volume 34, Issue 14, eff. April 5, 2018; Volume 37, Issue 25, eff. January 14, 2022; Errata, 39:5 VA.R. 943 October 24, 2022.

12VAC5-481-20 Scope

Except as otherwise specifically provided, these regulations apply to all persons who receive, possess, use, transfer, own, or acquire any source of radiation; provided, however, that nothing in these regulations shall apply to any person to the extent such person is subject to regulation by the NRC. Attention is directed to the fact that regulation by the state of source material, byproduct material, and special nuclear material in quantities not sufficient to form a critical mass is subject to the provisions of the agreement between the state and the NRC and to 10 CFR Part 150 of the commission's regulations.

To reconcile differences between this chapter and the incorporated sections of federal regulations and to effectuate their joint enforcement, the following words and phrases shall be substituted for the language of the federal regulations:

1. A reference to "NRC" or "Commission" means agency.

2. A reference to "NRC or agreement state" means agency, NRC or another agreement state.

3. The definition of "sealed source" includes NARM.

4. A reference to "byproduct material" includes NARM.

5. Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR shall be directed to the agency and, for NRC licenses, to the NRC until agreement state status is in effect.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-30 Deliberate misconduct

A. No person may do any of the following:

1. Engage in deliberate misconduct that causes or would have caused, if not detected, a licensee, registrant or applicant under this chapter to be in violation of any rule or order of the agency; or any term, condition or limitation of any license or registration issued by the agency under this chapter.

2. Deliberately submit to the agency, a licensee, registrant or applicant under this chapter; or a contractor or subcontractor of a licensee, registrant or applicant under this chapter; any information that the person knows to be incomplete or inaccurate.

B. Deliberate misconduct by a person means an intentional act or omission that the person knows:

1. Would cause a licensee, certificate of registration holder or applicant to be in violation of any rule, regulation, or order; or any term, condition, or limitation, of any license issued by the agency; or

2. Constitutes a violation of a requirement, procedure, instruction, contract, purchase order, or policy of a licensee, certificate of registration holder, applicant, contractor, or subcontractor.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Reserved, Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-40 Reserved. (Reserved)

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-50 Reserved. (Reserved)

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-60 Reserved. (Reserved)

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-70 Reserved. (Reserved)

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-80 Reserved. (Reserved)

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-90 Exemptions from regulatory requirements

A. The agency may, upon application or upon its own initiative, grant such exemptions or exceptions from the requirements of these regulations as it determines are authorized by law and will not result in undue hazard to public health and safety or property.

B. Any Department of Energy contractor or subcontractor and any NRC contractor or subcontractor of the following categories operating within this state is exempt from these regulations to the extent that such contractor or subcontractor under his contract receives, possesses, uses, transfers, or acquires sources of radiation:

1. Prime contractors performing work for the Department of Energy at United States government-owned or controlled sites, including the transportation of sources of radiation to or from such sites and the performance of contract services during temporary interruptions of such transportation;

2. Prime contractors of the Department of Energy performing research in, or development, manufacture, storage, testing, or transportation of, atomic weapons or components thereof;

3. Prime contractors of the Department of Energy using or operating nuclear reactors or other nuclear devices in a United States Government-owned vehicle or vessel; and

4. Any other prime contractor or subcontractor of the Department of Energy or of the NRC when the state and the NRC jointly determine:

a. That the exemption of the prime contractor or subcontractor is authorized by law; and

b. That, under the terms of the contract or subcontract, there is adequate assurance that the work thereunder can be accomplished without undue risk to the public health and safety.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-100 Records

A. Each licensee and registrant shall maintain records showing the receipt, transfer, and disposal of all sources of radiation as follows:

1. As long as the material is possessed and for three years following transfer or disposition of the radioactive material.

2. Until the agency terminates the license for the licensee who transferred the material.

3. Until the agency terminates the license for the licensee who disposes the material.

B. If radioactive material is combined or mixed with other licensed material and subsequently treated in a manner that makes direct correlation of a receipt record with a transfer, export, or disposition record impossible, the licensee may use evaluative techniques (such as first-in-first-out) to make the records that are required by this section account for 100% of the material received.

C. Additional record requirements are specified elsewhere in these regulations. If the record retention period is not specified, the record shall be maintained for a period of three years.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-110 Inspections and enforcement

A. Each licensee and registrant shall afford the agency at all reasonable times opportunity to inspect sources of radiation and the premises and facilities wherein such sources of radiation are used or stored.

B. Each licensee and registrant shall make available to the agency for inspection, upon reasonable notice, records maintained pursuant to these regulations.

C. Enforcement.

1. Whenever the department finds, following inspection and examination, that a source of radiation as constructed, operated or maintained results in a violation of this article or of any rules promulgated under this article, the department shall:

a. Notify the person in control of the source of radiation as to the nature of the violation; and

b. Specify a time frame for termination or abatement of the violation, including a deadline by which the source of the violation shall be reconstructed, operated, or maintained in compliance with this article and any regulations promulgated pursuant to this article.

2. Upon failure to comply within the time frame specified by the department for termination or abatement of the violation, the department may revoke the license, and pursue penalties or enforcement in accordance with § 32.1-27 of the Code of Virginia.

3. Whenever, in the judgment of the department, any person has engaged in or is about to engage in any acts or practices that constitute or will constitute an emergency, hazard to health and safety, or a violation of any provision of this article, or any rule, regulation or order issued thereunder, and at the request of the commissioner, the Attorney General may make application to the appropriate court for an order enjoining such acts or practices, or for an order directing compliance, and upon a showing by the department that such person has engaged or is about to engage in any such acts or practices, a permanent or temporary injunction, restraining order, or other order may be granted.

4. In addition to the provisions of § 32.1-27 of the Code of Virginia, any person who violates any provisions of this article or any order or regulation adopted pursuant thereto shall, upon such finding by a court of competent jurisdiction, be assessed a civil penalty of not more than $10,000 for each day of such violation. All penalties under this section shall be recovered in a civil action brought by the Attorney General in the name of the Commonwealth. Civil penalties collected pursuant to this section shall be paid into the state treasury and credited to the Radioactive Material Perpetual Care Trust Fund created pursuant to § 32.1-232 of the Code of Virginia.

5. In addition to the provisions of § 32.1-25 of the Code of Virginia, the department shall have the power to enter at all reasonable times, or in cases of an emergency, upon any private or public property for the purpose of determining whether or not there is compliance with or violation of the provisions of this article and rules and regulations issued thereunder, except that entry into areas under the jurisdiction of the federal government shall be effected only with the concurrence of the federal government or its duly designated representative.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-120 [Reserved]

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-130 Impounding

Sources of radiation shall be subject to impounding pursuant to § 32.1-238 of the Code of Virginia.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-140 Prohibited uses

A. A hand-held fluoroscopic screen shall not be used with X-ray equipment unless it has been listed in the Registry of Sealed Source and Devices or accepted for certification by the Food and Drug Administration, Center for Devices and Radiological Health.

B. Shoe-fitting fluoroscopic devices shall not be used.

C. No person shall intentionally apply or allow to be applied, either directly or indirectly, radiation to human beings except by, or under the supervision of, a practitioner of the healing arts licensed by this state, except in the case of healing arts screening programs approved in advance by the commissioner. Supervision, as used in this subsection, means the responsibility for and control of quality, radiation safety and technical aspects of the application of radiation to human beings for diagnostic or therapeutic purposes. This prohibition does not apply to persons who are occupationally exposed to radiation or as otherwise provided in these regulations.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-150 Communications

All communications and reports concerning this chapter, and applications filed thereunder, should be addressed to the agency at the following address: Virginia Department of Health, Radioactive Materials Program, 109 Governor Street, Room 730, Richmond, VA 23219.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-160 Effective date

The application of these regulations to possess by-product materials, source and special nuclear materials shall not become operative until 30 days after publication in the Virginia Register of a notice of an agreement executed by the Commonwealth of Virginia and the Federal Government under the provisions of Section 274b of the Atomic Energy Act of 1954, as amended (73 Statute 689). All other applications of the provisions of this chapter shall become effective September 20, 2006.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-170 Removal of notices posted by agency prohibited

Any sign, notice, warning or label affixed by the agency to equipment or facilities of any registrant or licensee shall not be removed, defaced or concealed by any person other than the agency without written permission.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-180 Tests

Each licensee and registrant shall perform upon instructions from the agency, or shall permit the agency to perform, such reasonable tests as the agency deems appropriate or necessary including, but not limited to, tests of:

1. Sources of radiation;

2. Facilities wherein sources of radiation are used or stored;

3. Radiation detection and monitoring instruments; and

4. Other equipment and devices used in connection with utilization or storage of licensed or registered sources of radiation.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-190 Additional regulatory requirements

The agency may, by rule, regulation, or order, impose upon any licensee or registrant such requirements in addition to those established in these regulations as it deems appropriate or necessary to minimize danger to public health and safety or property.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-200 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; repealed, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-210 Types of hearings

Hearings before the board, the commissioner, or their designees shall include any of the following forms depending upon the nature of the controversy and the interests of the parties involved. All concerned parties will be provided with a reasonable notice of any intent to consider any public data, documents or information in making case decisions.

1. Informal conference. An informal conference is a conference with the commissioner or his designee with concerned parties, in person, with counsel or other representatives held in accordance with § 2.2-4019 of the Code of Virginia.

2. Hearing. A hearing is a formal, public proceeding before the commissioner or a designated hearing officer and held in conformance with § 2.2-4020 of the Code of Virginia.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-220 Hearing as a matter of right

Any licensee or registrant whose licensure, certification or registration has been, or may be affected by any decision of the board or its subordinates in the administration of this chapter shall have a right to both informal and adjudicatory hearings. The commissioner may require participation in an informal hearing before granting the request for a full adjudicatory hearing.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-230 Appeal

A. Any appeal from a denial of a license or certification must be made in writing and received by the agency within 30 days of the date of receipt of notice of the denial.

B. Any request for hearing on the findings on a Notice of Violation pursuant to this regulation must be made in writing and received within 30 days of receipt of the final Notice of Violation.

C. Pursuant to the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia), an aggrieved licensee or registrant may appeal a final decision of the commissioner to an appropriate circuit court.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-240 Units of exposure and dose

A. As used in this chapter, the unit of exposure is the coulomb per kilogram (C/kg) of air and the units of radiation dose are gray (Gy), rad, rem, and sievert. (See 12VAC5-481-10 for definitions.) One roentgen is equal to 2.58E-4 coulomb per kilogram of air.

1. Gray (Gy) is the SI unit of absorbed dose. One gray is equal to an absorbed dose of 1 joule per kilogram (100 rad).

2. Rad is the special unit of absorbed dose. One rad is equal to an absorbed dose of 100 ergs per gram or 0.01 joule per kilogram (0.01 Gy).

3. Rem is the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor (1 rem = 0.01 Sv).

4. Sievert is the SI unit of any of the quantities as dose equivalent. The dose equivalent is equal to the absorbed dose in gray multiplied by the quality factor (1 Sv = 100 rem).

B. As used in this chapter, the quality factors for converting absorbed dose to dose equivalent are shown in Quality Factors and Absorbed Dose Equivalencies table in this subsection.

| | Quality Factors and Absorbed Dose Equivalencies | | | | --- | --- | --- | --- | | | Type of Radiation | Quality factor (Q) | Absorbed dose equal to a unit dose equivalent^a | | | X, gamma, or beta | 1 | 1 | | | Alpha particles, multiple-charged particles, fission fragments and heavy particles of unknown charge | 20 | 0.05 | | | Neutrons of unknown energy | 10 | 0.1 | | | High energy protons | 10 | 0.1 | | | ^aAbsorbed dose in rad equal to 1 rem or the absorbed dose in gray equal to 1 sievert. | | |

C. If it is more convenient to measure the neutron fluence rate than to determine the neutron dose equivalent rate in rems per hour or sieverts per hour, as provided in subsection B of this section, 1 rem (0.01 Sv) of neutron radiation of unknown energies may, for purposes of this chapter, be assumed to result from a total fluence of 25 million neutrons per square centimeter incident upon the body. If sufficient information exists to estimate the approximate energy of the neutrons, the licensee may use the fluence rate per unit dose equivalent of the approximate Q value from the Mean Quality Factors, Q, and Fluence per Unit Dose Equivalent for Monoenergetic Neutrons table in this subsection to convert a measured tissue dose in rads to dose equivalent in rems.

| | Mean Quality Factors, Q, and Fluence per Unit Dose Equivalent for Monoenergetic Neutrons | | | | | --- | --- | --- | --- | --- | | | | Neutron energy (MeV) | Quality factor (Q)^a | Fluence per unit dose equivalent (neutrons cm^-2 rem^-1)^b | | | (thermal) | 2.5 x 10^-8 | 2 | 980 x 10⁶ | | | 1 x 10^-7 | 2 | 980 x 10⁶ | | | | 1 x 10^-6 | 2 | 810 x 10⁶ | | | | 1 x 10^-5 | 2 | 810 x 10⁶ | | | | 1 x 10^-4 | 2 | 840 x 10⁶ | | | | 1 x 10^-3 | 2 | 980 x 10⁶ | | | | 1 x 10^-2 | 2.5 | 1010 x 10⁶ | | | | 1 x 10^-1 | 7.5 | 170 x 10⁶ | | | | 5 x 10^-1 | 11 | 39 x 10⁶ | | | | 1 | 11 | 27 x 10⁶ | | | | 2.5 | 9 | 29 x 10⁶ | | | | 5 | 8 | 23 x 10⁶ | | | | 7 | 7 | 24 x 10⁶ | | | | 10 | 6.5 | 24 x 10⁶ | | | | 14 | 7.5 | 17 x 10⁶ | | | | 20 | 8 | 16 x 10⁶ | | | | 40 | 7 | 14 x 10⁶ | | | | 60 | 5.5 | 16 x 10⁶ | | | | 1 x 10² | 4 | 20 x 10⁶ | | | | 2x10² | 3.5 | 19x10⁶ | | | | 3x10² | 3.5 | 16x10⁶ | | | | 4x10² | 3.5 | 14x10⁶ | | | | ^aValue of quality factor (Q) at the point where the dose equivalent is maximum in a 30-cm diameter cylinder tissue-equivalent phantom. ^bMonoenergetic neutrons incident normally on a 30-cm diameter cylinder tissue-equivalent phantom. | | | |

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-250 Units of radioactivity

For the purposes of this chapter, activity is expressed in the special unit of curies (Ci) or in the SI unit of becquerels (Bq), their multiples, or their disintegrations (transformations) per unit of time.

1. One becquerel equals 1 disintegration per second (s^-1).

2. One curie equals 3.7 x 10¹⁰ disintegrations per second equals 3.7 x 10¹⁰ becquerels equals 2.22 x 10¹² disintegrations per minute.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

Part II Registration of Radiation Machine Facilities and Services

12VAC5-481-260 Purpose and scope

A. This part provides for the registration of ionizing radiation machine facilities.

B. In addition to the requirements of this part, all registrants are subject to the applicable provisions of Part 1 (12VAC5-481-10 et seq.), Part IV (12VAC5-481-600 et seq.) and Part X (12VAC5-481-2250 et seq.) of this chapter. In addition, some registrants are subject to provisions of the regulations for Part V (12VAC5-481-1170 et seq.), Part VI (12VAC5-481-1580 et seq.), Part VIII (12VAC5-481-2090 et seq.) and Part IX (12VAC5-481-2140 et seq.) of this chapter.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-270 Exemptions

A. Electronic equipment that produces radiation incidental to its operation is exempt from the registration and notification requirements of this part, provided that the dose equivalent rate averaged over an area of 10 square centimeters does not exceed 5 μSv (0.5 mrem) per hour at five centimeters from any accessible surface of such equipment. The production, testing, or factory servicing of such equipment shall not be exempt.

B. Radiation machines while in transit or storage incident thereto are exempt from the requirements of this part.

C. Domestic television receivers are exempt from the requirements of this part.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-280 Shielding plan review

A. Prior to construction, the floor plans, shielding specifications and equipment arrangement of all new installations, or modifications of existing installations, utilizing ionizing radiation machines shall be available to the agency for review. The required information is found in 12VAC5-481-280 E.

B. The agency may require the applicant to utilize the services of a private inspector to determine the shielding requirements prior to the plan review.

C. The review of such plans shall not preclude the requirement of additional modifications should a subsequent analysis of operating conditions indicate the possibility of an individual receiving a dose in excess of the limits prescribed in 12VAC5-481-640 and 12VAC5-481-680 through 12VAC5-481-730.

D. After installation of a radiation machine, the registrant shall maintain for inspection by the agency:

1. The maximum rated technique factors of each machine;

2. A scale drawing of the room in which a stationary radiation machine system is located with such drawing indicating the use of areas adjacent to the room and an estimation of the extent of occupancy by an individual in such areas. In addition, the drawing shall include:

a. The results of a survey for radiation levels present at the operator's position and at pertinent points outside the room at specified test conditions; or

b. The type and thickness of materials, or lead equivalency, of each protective barrier.

E. In order for the private inspector to provide an evaluation, technical advice, and approval on shielding requirements for a radiation installation, the following information shall be required.

1. The plans showing, as a minimum, the following:

a. The normal location of the system's radiation port; the port's travel and traverse limits; general direction(s) of the useful beam; locations of any windows and doors or other openings; the location of the operator's booth; and the location of the control panel;

b. The structural composition and thickness or lead equivalent of all walls, doors, partitions, floor, and ceiling of the room(s) concerned;

c. The dimensions of the room(s) concerned;

d. The type of occupancy of all adjacent areas inclusive of space above and below the room(s) concerned. If there is an exterior wall, show distance to the closest area(s) where it is likely that individuals may be present;

e. The make and model of the equipment, the maximum technique factors, and the energy waveform (single phase, three phase, etc.);

f. The type of examination(s) or treatment(s) that will be performed with the equipment.

2. Information on the anticipated workload of the system(s) in Ma-minutes per week.

3. A report showing all basic assumptions used in the development of the shielding specifications.

F. The following requirements shall be used in the design for an operator's booth:

1. Space requirements:

a. The operator shall be allotted not less than 0.70 square meter (7.5 square feet) of unobstructed floor space in the booth;

b. The operator's booth may be any geometric configuration with no dimension of less than 0.6 m (2 feet);

c. The space shall be allotted excluding any encumbrance by the X-ray control panel, such as overhang, cables, or other similar encroachments;

d. The booth shall be located or constructed such that unattenuated direct scatter radiation originating on the examination table or at the wall-mounted image receptor will not reach the operator's position in the booth.

2. Structural requirements:

a. The booth walls shall be permanently fixed barriers of at least 2 m (7 feet) high;

b. When a door or movable panel is used as an integral part of the booth structure, it must have an interlock which will prevent an exposure when the door or panel is not closed;

c. Shielding shall be provided to meet the requirements of Part IV (12VAC5-481-600 et seq.) of this chapter.

3. Radiation exposure control placement: The radiation exposure control for the system shall be fixed within the booth and:

a. Shall allow the operator to remain in the protected area and not be exposed to direct scatter, leakage or primary beam radiation;

b. Shall allow the operator to use the majority of the available viewing windows.

4. Viewing system requirements:

a. Each booth shall have at least one viewing device that will:

(1) Be so placed that the operator can view the patient during any exposure; and

(2) Be so placed that the operator can have full view of any occupant of the room and should be so placed that the operator can view any entry into the room. If any door that allows access to the room cannot be seen from the booth, then outside that door there shall be an "X-ray on" warning sign that will be lighted anytime the rotor of the X-ray tube is activated. Alternatively, an interlock shall be present such that exposures are prevented unless the door is closed.

b. When the viewing system is a window, the following requirements also apply:

(1) The window shall have a viewing area of at least 0.09 square meter (1 square foot); Regardless of size or shape, at least 0.09 square meter (1 square foot) of the window area must be centered no less than 0.6 meter (2 feet) from the open edge of the booth and no less than 1.5 meter (5.0 feet) from the floor;

(2) The window shall have at least the same lead equivalence as that required in the booth's wall in which it is mounted.

c. When the viewing system is by mirrors, the mirror(s) shall be so located as to accomplish the general requirements of subdivision 1 of this subsection.

d. When the viewing system is by electronic means:

(1) The camera shall be so located as to accomplish the general requirements of subdivision 1 of this subsection; and

(2) There shall be an alternate viewing system as a backup for the primary system.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-290 Registration of radiation machine facilities

Each person having a radiation machine facility shall:

1. Apply for registration of such facility with the agency within 30 days following installation of equipment. Application for registration shall be completed on forms furnished by the agency and shall contain all the information required by the form and accompanying instructions. Registrations filed with the agency prior to September 20, 2006, shall remain in effect until a renewal notice is issued by the agency pursuant to 12VAC5-481-310.

2. Designate on the application form an individual to be responsible for radiation protection.

3. Submit to the agency as part of any application for registration or renewal of registration one copy of each radiation survey or calibration report for which records are required to be maintained pursuant to 12VAC5-481-1591 A 12 c. Records submitted once need not be submitted again for renewal of registration.

4. Have an initial inspection by a private or state inspector no later than 30 days after the registration of the equipment. Subsequent inspections shall be made periodically in accordance with other parts of these regulations or whenever the equipment is moved to a new location. The agency shall furnish a list of private inspectors.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 31, Issue 24, eff. August 27, 2015.

12VAC5-481-300 Issuance of registration certificate

A. Upon a determination that an applicant meets the requirements of this chapter and has paid the appropriate registration fee, the agency shall issue a registration certificate.

B. The agency may incorporate in the registration certificate at the time of issuance or thereafter by appropriate rule, regulation or order, such additional requirements and conditions with respect to the registrant's receipt, possession, use and transfer of radiation machines as he deems appropriate or necessary.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-310 Renewal of registration and approval not implied

A. Application for renewal of registration shall be filed in accordance with 12VAC5-481-290.

B. In any case in which a registrant not less than 30 days prior to the expiration of his existing registration certificate has filed an application in proper form for renewal, such existing registration certificate shall not expire until the application status has been finally determined by the agency.

C. No person, in any advertisement, shall refer to the fact that he or his facility is registered with the agency pursuant to the provisions of 12VAC5-481-290, and no person shall state or imply that any activity under such registration has been approved by the agency.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-320 Expiration of registration certificate

Except as provided by 12VAC5-481-310 B, each registration certificate shall expire at the end of the specified day in the month and year stated therein or upon notice issued to the registrant by the agency.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-330 Report of changes

The registrant shall notify the agency in writing before making any change that would render the information contained in the application for registration and/or the notice of registration no longer accurate.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-340 Private inspector qualifications

Any person desiring designation as a private inspector for diagnostic x-ray, mammographic or therapeutic x-ray and teletherapy machines must be qualified by training and experience to perform inspections or calibrations according to the following criteria and must submit to the agency a statement on the appropriate form certifying his specific qualifications. In order to maintain designation as a private inspector, the individual must maintain satisfactory performance of work performed in that capacity. The agency shall disqualify any individual from this designation if the agency has determined that the individual has demonstrated unsatisfactory performance as a private inspector. The individual may request an informal hearing.

A. Private inspector, diagnostic x-ray (except mammography). The person must have adequate knowledge, training and experience to measure ionizing radiation, evaluate safety techniques, and advise regarding radiation protection needs to assure compliance with Virginia Rules and Regulations for Ionizing Radiation as evidenced by all of the following:

1. Initial qualifications: evidenced by one or more of the following:

a. Certification by one of the following: American Board of Radiology either in diagnostic or radiological physics, American Board of Health Physics in comprehensive practice, or the American Board of Medical Physics in diagnostic imaging physics.

b. Bachelor's degree in one of the physical sciences or engineering and three years of full-time experience in radiation safety including at least one year in diagnostic x-ray safety. Advanced degrees in related areas may be substituted for experience on an equal time basis, except that no substitution shall be allowed for the required one year of experience in diagnostic x-ray safety.

c. Those individuals listed as private inspectors immediately prior to September 20, 2006, shall be considered grandfathered.

2. Continuing qualifications:

a. Continuing education. Private inspectors must participate in continuing education programs relating to diagnostic x-ray, either by teaching or completing at least 15 continuing education units (CMEs) every three years.

b. Continuing experience. The private inspector must have inspected at least 10 diagnostic x-ray machines within the preceding 12 months.

3. Reestablishing qualifications. Private inspectors who fail to maintain the required continuing qualifications of this section may not perform the inspections without the supervision of a qualified private inspector. Before independently inspecting another facility, private inspectors must reestablish their qualifications, as follows:

a. Private inspectors who fail to meet the continuing educational requirements of this section shall obtain a sufficient number of continuing education units to bring their total units up to five continuing education units during the preceding 12 months.

b. Private inspectors who fail to meet the continuing experience requirement of this section shall complete a satisfactory inspection of a sufficient number of facilities and machines under the direct supervision of a private inspector who meets the qualifications of this section to bring the number to the required level.

B. Private inspector, therapeutic x-ray and teletherapy machines. The person must have adequate knowledge, training, and experience to calibrate a therapeutic x-ray machine or teletherapy machine, perform inspections and to establish procedures for (and review the results of) spot-check measurements as evidenced by all of the following:

1. Initial qualifications: evidenced by one or more of the following:

a. Be certified by the American Board of Radiology in:

(1) Therapeutic radiological physics or therapeutic medical physics;

(2) Roentgen-ray and gamma-ray physics;

(3) X-ray and radium physics;

(4) Radiological physics;

b. Be certified by the American Board of Medical Physics in Radiation Oncology Physics;

c. Be certified by the Canadian College of Medical Physics; or

d. Hold a master's or doctor's degree in physics, biophysics, radiological physics, or health physics, and have completed one year of full time training in therapeutic radiological physics and also one year of full time work experience under the supervision of a radiation therapy physicist at a medical institution. To meet this requirement, the individual shall have performed the tasks listed in 12VAC5-481-3400 A, 12VAC5-481-3420 P, 12VAC5-481-3420 Q, 12VAC5-481-3430 T, and 12VAC5-481-3430 U under the supervision of a radiation therapy physicist during the year of work experience.

Notwithstanding the provisions of 12VAC5-481-3390 D, certification pursuant to subdivisions B 1 a, b, or c of this section shall be required on or before July 1, 2007, for all persons currently qualifying as a radiation therapy physicist pursuant to subdivision B 1 d of this section.

2. Continuing qualifications.

a. Private inspectors must participate in continuing education programs relating to therapeutic x-ray and teletherapy machines, either by teaching or completing at least 15 continuing education units (CEUs) every three years.

b. The private inspector must have inspected at least one therapeutic x-ray or teletherapy facilities and at least one therapeutic x-ray or teletherapy machine within the preceding 12 months.

3. Reestablishing qualifications. Private inspectors who fail to maintain the required continuing qualifications of this section may not perform an inspection without the supervision of a qualified private inspector. Before independently inspecting another facility, private inspectors must reestablish their qualifications, as follows:

a. Private inspectors who fail to meet the continuing educational requirements of this section shall obtain a sufficient number of continuing education units to bring their total units up to five continuing education units during the preceding 12 months.

b. Private inspectors who fail to meet the continuing experience requirement of this section shall complete a satisfactory inspection of a sufficient number of facilities and machines under the direct supervision of a private inspector who meets the qualifications of this section to bring the number to the required level.

C. Private inspector, mammography. The person must have adequate knowledge, training, and experience to inspect mammography x-ray machines and facilities. All mammography private inspector conducting inspections of mammography facilities and providing oversight of the facility quality assurance program must meet one of the following tracks, either through the initial master's degree of higher route or the alternative initial bachelor's degree route:

1. Initial qualifications:

Master Route:

a. Be certified by the American Board of Radiology (ABR) or the American Board of Medical Physics (ABMP) in:

(1) Diagnostic radiological physics;

(2) Radiological physics; or

(3) Diagnostic imaging physics;

b. A master's degree or higher in a physical science with at least 20 semester hours or equivalent of graduate or undergraduate physics; and

c. Twenty contact hours of mammography facility training; and

d. The experience of conducting inspections of at least one mammography facility and a total of at least 10 mammography units.

Bachelor Route (must have been qualified before April 28, 1999):

a. A bachelor's degree in a physical science with at least 10 semester hours or equivalent of college level physics;

b. Forty contact hours of documented specialized training in conducting inspections of mammography facilities; and

c. The experience of conducting inspections of at least one mammography facility and a total of at least 20 mammography units. The training and experience requirements must be met after fulfilling the degree requirement.

2. Continuing qualifications.

a. At all times after the third anniversary of completion of the initial requirements of this section, the private inspector shall have taught or completed at least 15 continuing education units in mammography during the preceding three years.

b. At all times after the first anniversary of the completion of the initial requirements of this section, the private inspector shall have inspected at least two mammography facilities and six machines in 24 months.

c. Before a private inspector may begin independently performing mammographic examinations using a new modality, that is, a modality other than one for which the physicist received training to qualify under this section, the inspector must receive at least eight hours of training in inspecting units with the new modality.

3. Reestablishing qualifications. Private inspectors who fail to maintain the required continuing qualifications of this section may not perform the mammography inspections without the supervision of a qualified private inspector. Before independently inspecting another facility, private inspectors must reestablish their qualifications as follows:

a. Private inspectors who fail to meet the continuing educational requirements of this section shall obtain a sufficient number of continuing education units to bring their total units up to the required 15 in the previous three years.

b. Private inspectors who fail to meet the continuing experience requirement of this section shall complete a satisfactory inspection of three mammography facilities under the direct supervision of a private inspector who meets the qualifications of this section.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 31, Issue 24, eff. August 27, 2015.

12VAC5-481-350 Assembler or transfer obligation

A. Any person who sells, leases, transfers, lends, disposes, assembles, or installs radiation machines or upon significant service or modification thereof of any radiation machine (such as tube inserts, generators, or collimators) in this state shall notify the agency within 15 days of:

1. The name and address of persons who have received these machines;

2. The manufacturer, model, and serial number of each radiation machine transferred; however, in the case of diagnostic x-ray systems that contain certified components, a copy of the assembler's report (Form FDA 2579) prepared in compliance with the requirements of the Food and Drug Administration's Federal Diagnostic X-ray Standard (21 CFR 1020.30(d)) shall be submitted and shall suffice in lieu of any other report by the assembler; and

3. The date of transfer of each radiation machine.

B. No person shall make, sell, lease, transfer, lend, assemble, or install radiation machines or the supplies used in connection with such machines unless such supplies and equipment when properly placed in operation and used shall meet the requirements of these regulations.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 31, Issue 24, eff. August 27, 2015.

12VAC5-481-360 Reciprocal recognition of out-of-state radiation machines

A. Whenever any radiation machine is to be brought into the state, for any temporary use, the person proposing to bring such machine into the state shall give written notice to the agency at least two working days before such machine is to be used in the state. The notice shall include:

1. The type of radiation machine;

2. The nature, duration, and scope of use;

3. The exact location(s) where the radiation machine is to be used; and

4. States in which this machine is registered.

B. If, for a specific case, the two-working-day period would impose an undue hardship on the person, upon application to the agency, permission to proceed sooner may be granted.

C. The person referred to in subsection A of this section shall:

1. Comply with all applicable regulations of the agency;

2. Supply the agency with such other information as the agency may reasonably request; and

3. Not operate within the state on a temporary basis in excess of 180 calendar days per year.

4. Supply the agency a copy of a medical physicist or private inspector report not less than one year old indicating the equipment is certified by another state.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-370 Certification of X-ray systems

A. Every owner or operator of an X-ray machine shall:

1. Have the machine certified by the agency within 60 days of the date of installation and thereafter according to the inspection schedule in Part VI (12VAC5-481-1580 et seq.) of this chapter; and

2. Have the machine inspected whenever the machine is moved to a new location or according to the schedule in Part VI (12VAC5-481-1580 et seq.) of this chapter, whichever occurs first, by a private or state inspector; and

3. Submit to the agency one copy of each inspection or calibration report for which records are required to be maintained pursuant to Part VI (12VAC5-481-1580 et seq.) of this chapter. If the inspection was performed by a state inspector and the inspection was not initiated by the agency pay the appropriate fee as established by the board.

B. Certification may be denied if any noncompliances are not corrected within 45 days from the date of inspection.

C. The agency shall issue a certificate when the data indicates the machine meets the board's standards. A copy of the certificate shall be displayed by the registrant in a conspicuous place in close proximity to the X-ray machine.

D. Certification may be denied if the machine does not meet the standards set forth in these regulations. If the certification is denied, the machine shall not be used for treatment, diagnosis, or evaluation of patients, whether human or animal, until the standards of the board have been met.

E. Final disposition of the machine, including electrical disconnection or storage, will be made within 90 days of agency review.

F. For facilities providing mammography services, the agency may conduct scheduled and random unannounced inspections, to ensure compliance with laws, regulations, or conditions specified by the board.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 1 Purpose and Scope

12VAC5-481-380 Purpose and scope

Article 1 Purpose and Scope

A. This part, and Parts V (12VAC5-481-1170 et seq.), VII (12VAC5-481-1660 et seq.), XI (12VAC5-481-2330 et seq.), XIII (12VAC5-481-2950 et seq.), XIV (12VAC5-481-3140 et seq.) and XVI (12VAC5-481-3460 et seq.) of this chapter, provide for the licensing of radioactive material. No person shall receive, possess, use, transfer, own, or acquire radioactive material except as authorized pursuant to this part or Parts V (12VAC5-481-1170 et seq.), VII (12VAC5-481-1660 et seq.), XI (12VAC5-481-2330 et seq.), XII (12VAC5-481-2660 et seq.), XIII (12VAC5-481-2950 et seq.), XIV (12VAC5-481-3140 et seq.) and XVI (12VAC5-481-3460 et seq.) of this chapter, or as otherwise provided in these parts.

B. In addition to the requirements of this part, all licensees are subject to the requirements of Parts I (12VAC5-481-10 et seq.), IV (12VAC5-481-600 et seq.), X (12VAC5-481-2250 et seq.), and XIII (12VAC5-481-2950 et seq.) of this chapter. Furthermore, licensees engaged in industrial radiographic operations are subject to the requirements of Part V (12VAC5-481-1170 et seq.) of this chapter, licensees using radionuclides in the healing arts are subject to the requirements of Part VII (12VAC5-481-1660 et seq.) of this chapter, licensees engaged in irradiator operations are subject to the requirements of Part XII (12VAC5-481-2660 et seq.) of this chapter, and licensees engaged in wireline and subsurface tracer studies are subject to the requirements of Part XIV (12VAC5-481-3140 et seq.) of this chapter.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 2 Exemptions from the Regulatory Requirements

12VAC5-481-390 Source material

Article 2 Exemptions from the Regulatory Requirements

A. Common and contract carriers, freight forwarders, warehousemen, and the U.S. Postal Service are exempt from this part and the requirements for a license set forth in this chapter to the extent that they transport or store radioactive material in the regular course of the carriage for another or storage incident thereto.

B. Any person is exempt from Part III (12VAC5-481-380 et seq.) of this chapter to the extent that such person receives, possesses, uses, owns, transfers, or delivers source material in any chemical mixture, compound, solution, or alloy in which the source material is by weight less than 0.05% of the mixture, compound, solution or alloy. The exemption contained in this chapter does not apply to Australian-obligated radioactive material, nor does it include byproduct materials as defined in 12VAC5-481-10.

C. Any person is exempt from Part III (12VAC5-481-380 et seq.) of this chapter to the extent that such person receives, possesses, uses, or transfers unrefined and unprocessed ore containing source material; provided that, except as authorized in a specific license, such person shall not refine or process such ore.

D. Any person is exempt from Parts III (12VAC5-481-380 et seq.), IV (12VAC5-481-600 et seq.), and X (12VAC5-481-2250 et seq.) of this chapter to the extent such person receives, possesses, uses, or transfers:

1. Any quantities of thorium contained in (i) incandescent gas mantles, (ii) vacuum tubes; (iii) welding rods; (iv) electric lamps for illuminating purposes provided that each lamp does not contain more than 50 milligrams of thorium; (v) germicidal lamps, sunlamps, and lamps for outdoor or industrial lighting provided that each lamp does not contain more than 2 grams of thorium; (vi) rare earth metals and compounds, mixtures, and products containing not more than 0.25% by weight thorium, uranium, or any combination of these; or (vii) personnel neutron dosimeters provided that each dosimeter does not contain more than 50 milligrams of thorium.

2. Source material contained in the following products:

a. Glaze ceramic tableware manufactured before August 27, 2013, provided that the glaze contains not more than 20% by weight source material;

b. Piezoelectric ceramic containing not more than 2.0% by weight source material;

c. Glassware containing not more than 2.0% by weight source material or for glassware manufactured before August 27, 2013, 10% by weight source material, but not including commercially manufactured glass brick, pane glass, ceramic tile, or other glass or ceramic used in construction; or

d. Glass enamel or glass enamel frit containing not more than 10% by weight source material imported or ordered for importation into the United States, or initially distributed by manufacturers in the United States, before July 25, 1983. (On July 25, 1983, the exemption of glass enamel or glass enamel frit was suspended. The exemption was eliminated on September 11, 1984.)

3. Photographic film, negatives, and prints containing uranium or thorium.

4. Any finished product or part fabricated of or containing tungsten-thorium or magnesium-thorium alloys, provided that the thorium content of the alloy does not exceed 4.0% by weight and that the exemption shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of any such product or part.

5. Uranium contained in counterweights installed in aircraft, rockets, projectiles, and missiles, or stored or handled in connection with installation or removal of such counterweights provided that:

a. Each counterweight has been impressed with the following legend clearly legible through any plating or other covering: "Depleted Uranium";

b. Each counterweight is durably and legibly labeled or marked with the identification of the manufacturer, and the statement: "Unauthorized Alterations Prohibited" (The requirements of this subdivision need not be met by counterweights manufactured prior to December 31, 1969, provided that such counterweights were manufactured under a specific license issued by the Atomic Energy Commission and were impressed with the legend required by 10 CFR 40.13(c)(5)(ii) in effect on June 30, 1969); and

c. The exemption contained in this subsection shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of any such counterweights other than repair or restoration of any plating or other covering.

6. Natural or depleted uranium metal used as shielding constituting part of any shipping container, provided that:

a. The shipping container is conspicuously and legibly impressed with the legend: "CAUTION—RADIOACTIVE SHIELDING—URANIUM", and

b. The uranium metal is encased in mild steel or equally fire-resistant metal of minimum wall thickness of 1/8 inch (3.2 mm).

7. Thorium or uranium contained in or on finished optical lenses and mirrors, provided that each lens or mirror does not contain more than 10% by weight thorium or uranium or, for lenses manufactured before August 27, 2013, 30% by weight of thorium; and that the exemption contained in this paragraph does not authorize either:

a. The shaping, grinding, or polishing of such lens or mirror or manufacturing processes other than the assembly of such lens or mirror into optical systems and devices without any alteration of the lens or mirror; or

b. The receipt, possession, use, or transfer of uranium or thorium contained in contact lens, spectacles, or eyepieces in binoculars or other optical instruments.

8. Thorium contained in any finished aircraft engine part contained nickel-thoria alloy, provided that:

a. The thorium is dispersed in the nickel-thoria alloy in the form of finely divided thoria (thorium dioxide); and

b. The thorium content in the nickel-thoria alloy does not exceed 4.0% by weight.

9. The exemptions in this subsection do not authorize the manufacture of any products described.

10. No person may initially transfer for sale or distribution a product containing source material to persons exempt under this subsection or equivalent regulations of the NRC or another agreement state, unless authorized by the NRC with a license issued under 10 CFR 40.52 to initially transfer such products for sale or distribution.

a. Persons initially distributing source material in products covered by the exemptions in this section before August 27, 2013, without specific authorization may continue such distribution for one year beyond this date. Initial distribution may also be continued until the NRC takes final action on a pending application for license or license amendment to specifically authorize distribution submitted no later than one year beyond this date.

b. Persons authorized to manufacture, process, or produce these materials or products containing source material, and persons who import finished products or parts, for sale or distribution shall be authorized by an NRC license issued under 10 CFR 40.52 for distribution only and are exempt from the requirements of 12VAC5-481-450 and Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 25, Issue 2, eff. November 1, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 33, Issue 11, eff. February 22, 2017.

12VAC5-481-400 Radioactive material other than source material

A. Exempt concentrations.

1. Except as provided in subdivisions 3 and 4 of this subsection, any person is exempt from the requirements for a license set forth in this part to the extent that such person receives, possesses, uses, transfers, owns, or acquires products or materials containing radioactive material in concentrations not in excess of those listed in 12VAC5-481-3720.

2. This subsection shall not be deemed to authorize the import of radioactive material or products containing radioactive material.

3. A manufacturer, processor, or producer of a product or material is exempt from the requirements for a license set forth in this part to the extent that this person transfers radioactive material (i) contained in a product or material in concentrations not in excess of those specified in 12VAC5-481-3720 and (ii) introduced into the product or material by a licensee holding a specific license issued by the NRC expressly authorizing such introduction. This exemption does not apply to the transfer of radioactive material contained in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by or application to a human being.

4. No person may introduce radioactive material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under this subsection or equivalent regulations by the NRC or another agreement state except in accordance with a license issued under 12VAC5-481-480.

B. Exempt quantities.

1. Except as provided in subdivisions 3, 4, and 5 of this subsection, any person is exempt from the requirements of this chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material in individual quantities, each of which does not exceed the applicable quantity set forth in 12VAC5-481-3730.

2. Any person who possesses radioactive material received or acquired before September 25, 1971, under the general license provided in 12VAC5-481-430 is exempt from the requirements for a license set forth in this part and from the regulations contained therein to the extent that this person possesses, uses, transfers, or owns radioactive material.

3. This subsection does not authorize for purposes of commercial distribution the production, packaging, repackaging, or transfer of radioactive material or the incorporation of radioactive material into products intended for commercial distribution.

4. No person may, for purposes of commercial distribution, transfer radioactive material in the individual quantities set forth in 12VAC5-481-3730, knowing or having reason to believe that such quantities of radioactive material will be transferred to persons exempt under this part or equivalent regulations of the NRC or another agreement state, except in accordance with a license issued under 12VAC5-481-480, which license states that the radioactive material may be transferred by the licensee to persons exempt under this part or the equivalent regulations of the NRC or another agreement state.

5. No person may, for purposes of producing an increased radiation level, combine quantities of radioactive material covered by this exemption so that the aggregate quantity exceeds the limits set forth in 12VAC5-481-3730, except for radioactive material combined within a device placed in use before May 3, 1999, or as otherwise permitted by this part.

C. Exempt items.

1. Except for persons who apply radioactive material to or persons who incorporate radioactive material into the following products, or persons who initially transfer for sale or distribution the following products containing radioactive material, any person is exempt from this chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires the following products:

a. Timepieces or hands or dials containing not more than the following specified quantities of radioactive material and not exceeding the following specified quantities:

(1) 25 mCi (925 MBq) of tritium per timepiece;

(2) 5 mCi (185 MBq) of tritium per hand;

(3) 15 mCi (555 MBq) of tritium per dial (bezels when used shall be considered as part of the dial);

(4) 100 μCi (3.7 MBq) of promethium 147 per watch or 200 μCi (7.4 MBq) of promethium 147 per any other timepiece;

(5) 20 μCi (0.74 MBq) of promethium 147 per watch hand or 40 μCi (1.48 MBq) of promethium 147 per other timepiece hand;

(6) 60 μCi (2.22 MBq) of promethium 147 per watch dial or 120 μCi (4.44 MBq) of promethium 147 per other timepiece dial (bezels when used shall be considered as part of the dial);

(7) The levels of radiation from hands and dials containing promethium 147 will not exceed, when measured through 50 milligrams per square centimeter of absorber:

(a) For wrist watches, 0.1 millirad per hour (1 microgray per hour) at 10 centimeters from any surface,

(b) For pocket watches, 0.1 millirad per hour (1 microgray per hour) at 1 centimeter from any surface, or

(c) For any other timepiece, 0.2 millirad per hour (1 microgray per hour) at 10 centimeters from any surface; or

(8) 1 μCi (37 kBq) of radium-226 per timepiece in intact timepieces manufactured prior to November 30, 2007.

b. Other products including:

(1) Static elimination devices that contain, as a sealed source or sources, radioactive material consisting of a total of not more than 500 μCi (18.5 MBq) of polonium-210 per device;

(2) Ion generating tubes designed for ionization of air that contain, as a sealed source or sources, radioactive material consisting of a total of not more than 500 μCi (18.5 MBq) of polonium-210 per device or of a total of not more than 50 mCi (1.85 GBq) of hydrogen-3 (tritium) per device; and

(3) Such devices authorized before October 23, 2012, for use under the general license then provided in 12VAC5-481-430 and equivalent regulations of the NRC or another agreement state and manufactured, tested, and labeled by the manufacturer in accordance with the specifications contained in a specific license issued by the agency, the NRC, or another agreement state.

c. Balances of precision containing not more than 1 mCi (37 MBq) of tritium per balance or not more than 0.5 mCi (18.5 MBq) of tritium per balance part manufactured before December 17, 2007.

d. (Reserved.)

e. Marine compasses containing not more than 750 mCi (27.8 GBq) of tritium gas and other marine navigational instruments containing not more than 250 mCi (9.25 GBq) of tritium gas manufactured before December 17, 2007.

f. (Reserved.)

g. Ionization chamber smoke detectors containing not more than 1 μCi (37 kBq) of americium-241 per detector in the form of a foil and designed to protect life and property from fires.

h. Electron tubes (includes: spark gap tubes, power tubes, gas tubes including glow lamps, receiving tubes, microwave tubes, indicator tubes, pickup tubes, radiation detection tubes, and any other completely sealed tube that is designed to conduct or control electrical currents),providedthat each tube does not contain more than one of the following specified quantities:

(1) 150 mCi (5.55 GBq) of tritium per microwave receiver protector tube or 10 mCi (370 MBq) of tritium per any other electron tube;

(2) 1 μCi (37 kBq) of cobalt-60;

(3) 5 μCi (185 kBq) of nickel-63;

(4) 30 μCi (1.11 MBq) of krypton-85;

(5) 5 μCi (185 kBq) of cesium-137; or

(6) 30 μCi (1.11 MBq) of promethium-147; and

(7) Provided further that the levels of radiation dose from each electron tube containing radioactive material do not exceed 1 millirad per hour (10 microgray per hour) at 1 centimeter (0.39 inches) from any surface when measured through 7 milligrams per square centimeter of absorber.

i. Ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, one or more sources of radioactive material, provided that:

(1) Each source contains no more than one exempt quantity set forth in 12VAC5-481-3730, and

(2) Each instrument contains no more than 10 exempt quantities. For purposes of this subdivision, an instrument's source or sources may contain either one type or different types of radionuclides and an individual exempt quantity may be composed of fractional parts of one or more of the exempt quantities in 12VAC5-481-3730, provided that the sum of such fractions shall not exceed unity.

(3) For purposes of this subdivision, 0.05 μCi (1.85 kBq) of americium-241 is considered an exempt quantity under 12VAC5-481-3730.

j. (Reserved.)

2. Any person who desires to apply radioactive material to, or to incorporate radioactive material into, the products exempted in subdivision 1 of this subsection, or who desires to initially transfer for sale or distribution such products containing radioactive material, should apply for a specific license pursuant to 12VAC5-481-480 C, which license states that the product may be distributed by the licensee to persons exempt from the regulations pursuant to subdivision 1 of this subsection.

D. Self-luminous products containing radioactive material.

1. Except for persons who manufacture, process, produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85, or promethium-147, or except as provided in subdivision 3 of this subsection, any person is exempt from the requirements for a license set forth in this part to the extent that such person receives, possesses, uses, transfers, own, or acquires tritium, krypton-85, or promethium-147 in self-luminous products manufactured, processed, produced, or initially transferred in accordance with a specific license issued pursuant to 12VAC5-481-480 D, which license authorizes the initial transfer of the product to persons who are exempt from regulatory requirements.

2. Any person is exempt from this chapter to the extent that such person receives, possesses, uses, transfers, or owns articles containing less than 0.1 microcurie (3.7 kBq) of radium-226 acquired prior to September 1, 1980.

3. Any person who desires to manufacture, process, produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85, or promethium-147 for use under subdivision 1 of this subsection should apply for a license and for a certificate of registration in accordance with 12VAC5-481-480 D.

4. The exemption in subdivision 1 of this subsection does not apply to tritium, krypton-85, or promethium-147 used in products primarily for frivolous purposes or in toys or adornments.

E. Gas and aerosol detectors containing radioactive material.

1. Except for persons who manufacture, process, produce, or initially transfer for sale or distribution gas and aerosol detectors containing radioactive material, any person is exempt from this chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material in gas and aerosol detectors designed to protect health, safety, or property from fires and airborne hazards provided that the detectors containing radioactive material shall have been manufactured, processed, produced, or initially transferred in accordance with a specific license issued under 12VAC5-481-480 E, which license authorizes use under this subsection. This exemption also covers gas and aerosol detectors manufactured or distributed before November 30, 2007, in accordance with a specific license issued by the NRC or another agreement state under provisions comparable to 12VAC5-481-480 C authorizing distribution to persons exempt from regulatory requirements.

2. Any person who desires to manufacture, process, or produce gas and aerosol detectors containing radioactive material, or to initially transfer such products for use under subdivision 1 of this subsection, should apply to the agency for a license in accordance with 12VAC5-481-480 C and for a certificate of registration with the NRC in accordance with 10 CFR 32.210.

3. Gas and aerosol detectors previously manufactured and distributed to general licensees in accordance with a specific license issued by an agreement state shall be considered exempt under subdivision 1 of this subsection, provided that the device is labeled in accordance with the specific license authorizing distribution of the generally licensed device, and provided further that they meet the requirements of 12VAC5-481-480 C.

4. Gas and aerosol detectors containing NARM previously manufactured and distributed in accordance with a specific license issued by the NRC or another agreement state shall be considered exempt under subdivision 1 of this subsection, provided that the device is labeled in accordance with the specific license authorizing distribution, and provided further that they meet the requirements of 12VAC5-481-480 C.

F. Radioactive drug: Capsules containing carbon-14 urea for "in-vivo" diagnostic use for humans.

1. Except as provided in subdivision 2 of this subsection, any person is exempt from the requirements for a license set forth in this part, provided that such person receives, possess, uses, transfers, owns, or acquires capsules containing 1 μCi (37 kBq) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each for "in vivo" diagnostic use for humans.

2. Any person who desires to use the capsules for research involving human subjects shall apply for and receive a specific license pursuant to Part VII (12VAC5-481-1660 et seq.) of this chapter.

3. Any person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsules shall apply for a license under and a certification of registration in accordance with 12VAC5-481-480 I.

4. Nothing in this subsection relieves persons from complying with applicable U.S. Food and Drug Administration (FDA), other federal, and state requirements governing receipt, administration, and use of drugs.

G. Carriers. Common and contract carriers, freight forwarders, warehousemen, and the U.S. Postal Service are exempt from this part to the extent that they transport special nuclear material in the regular course of carriage for another or storage incident thereto. This exemption does not apply to the storage in transit or transport of material by persons covered by a general license issued under 12VAC5-481-430 E.

H. Certain industrial devices.

1. Except for persons who manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing radioactive material designed and manufactured for the purpose of detecting, measuring, gauging, or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing an ionized atmosphere, any person is exempt from the requirements for a license set forth in § 32.1-229 of the Code of Virginia and in Parts III (12VAC5-481-380 et seq.), IV (12VAC5-481-600 et seq.), V (12VAC5-481-1170 et seq.), VII (12VAC5-481-1660 et seq.), X (12VAC5-481-2250 et seq.), XII (12VAC5-481-2660 et seq.), and XIV (12VAC5-481-3140 et seq.) of this chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material, in these certain detecting, measuring, gauging, or controlling devices and certain devices for producing an ionized atmosphere, and manufactured, processed, produced, or initially transferred in accordance with a specific license issued by the NRC under 10 CFR 32.30, which license authorizes the initial transfer of the device for use under this subsection. This exemption does not cover sources not incorporated into a device, such as calibration and reference sources.

2. Any person who desires to manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing radioactive material for use under subdivision 1 of this subsection, should apply to the NRC for a license under 10 CFR 32.30 and for a certificate of registration in accordance with 10 CFR 32.210.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 25, Issue 2, eff. November 1, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 33, Issue 11, eff. February 22, 2017.

Article 3 Licenses

12VAC5-481-410 Types of licenses

Article 3 Licenses

A radioactive materials license will be one of the following:

1. A general license is provided by regulation, grants authority to a person for certain activities involving radioactive material, and is effective without the filing of an application with the agency or the issuance by the agency of licensing documents to the particular person; although, the filing of a certificate with the agency may be required by the particular general license. The general licensee is subject to all applicable parts of this chapter and any limitations of the general license.

2. A specific license requires the submission of an application to the agency and the issuance of a licensing document to a named person by the agency. A licensee is subject to all applicable parts of this chapter as well as any limitations specified in the licensing document.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-420 General licenses -- source material

A. Small quantities of source material.

1. A general license is hereby issued authorizing commercial and industrial firms; research, educational, and medical institutions; and federal, state, and local government agencies to receive, possess, use, and transfer uranium and thorium, in their natural isotopic concentrations and in the form of depleted uranium, for research, development, educational, commercial, or operational purposes in the following forms and quantities:

a. No more than 1.5 kg (3.3 lb) of uranium and thorium in dispersible forms (e.g. gaseous, liquid, powder, etc.) at any one time. Any material processed by the general licensee that alters the chemical or physical form of the material containing source material shall be accounted for as a dispersible form. A person authorized to possess, use, and transfer source material under this subdivision may not receive more than a total of 7 kg (15.4 lb) of uranium and thorium in any one calendar year; and

b. No more than a total of 7 kg (15.4 lb) of uranium and thorium at any one time. A person authorized to possess, use, and transfer source material under this subdivision may not receive more than a total of 70 kg (154 lb) of uranium and thorium in any one calendar year. A person may not alter the chemical or physical form of the source material possessed under this subdivision unless it is accounted for under the limits of subdivision 1 a of this subsection; or

c. No more than 7 kg (15.4 lb) of uranium, removed during the treatment of drinking water, at any one time. A person may not remove more than 70 kg (154 lb) of uranium from drinking water during a calendar year under this paragraph; or

d. No more than 7 kg (15.4 lb) of uranium and thorium at laboratories for the purpose of determining the concentration of uranium and thorium contained within the material being analyzed at any one time. A person authorized to possess, use, and transfer source material under this paragraph may not receive more than a total of 70 kg (154 lb) of source material in any one calendar year.

2. Any person who receives, possesses, uses, or transfers source material in accordance with the general license in subdivision 1 of this subsection:

a. Is prohibited from administering source material, or the radiation therefrom, either externally or internally, to human beings except as may be authorized by the agency in a specific license.

b. Shall not abandon such source material. Source material may be disposed of as follows:

(1) A cumulative total of 0.5 kg (1.1 lb) of source material in a solid, nondispersible form may be transferred each calendar year, by a person authorized to receive, possess, use, and transfer source material under this general license to persons receiving the material for permanent disposal. The recipient of source material transferred under the provisions of this subdivision is exempt from the requirements to obtain a license under this part to the extent the source material is permanently disposed. This provision does not apply to any person who is in possession of source material under a specific license issued under this chapter; or

(2) In accordance with 12VAC5-481-910.

c. Is subject to the provisions in 12VAC5-481-100, 12VAC5-481-110, 12VAC5-481-380, 12VAC5-481-500, 12VAC5-481-570, 12VAC5-481-580, and 12VAC5-481-1110.

d. Shall not export such source material except in accordance with 10 CFR Part 110.

3. Any person who receives, possesses, uses, or transfers source material in accordance with subdivision 1 of this subsection shall conduct activities so as to minimize contamination of the facility and the environment. When activities involving such source material are permanently ceased at any site, if evidence of significant contamination is identified, the general licensee shall notify the agency about such contamination and may consult with the agency as to the appropriateness of sampling and restoration activities to ensure that any contamination or residual source material remaining at the site where source material was used under this general license is not likely to result in exposures that exceed the limits in 12VAC5-481-1161.

4. Any person who receives, possesses, uses, or transfers source material in accordance with the general license granted in subdivision 1 of this subsection is exempt from the provisions of Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter to the extent that such receipt, possession, use, and transfer are within the terms of this general license, except that such person shall comply with the provisions of 12VAC5-481-910 and 12VAC5-481-1161 to the extent necessary to meet the provisions of subdivisions 2 (b) and 3 of this subsection. However, this exemption does not apply to any person who also holds a specific license issued under this chapter.

5. No person may initially transfer or distribute source material to persons generally licensed under subdivision 1 a or b of this subsection, or equivalent regulations of the NRC or another agreement state, unless authorized by a specific license issued in accordance with subdivision E of this subsection or equivalent provisions of the NRC or another agreement state. This prohibition does not apply to analytical laboratories returning processed samples to the client who initially provided the sample.

B. General license to receive title to source or radioactive material. A general license is hereby issued authorizing the receipt of title to source or radioactive material without regard to quantity. This general license does not authorize any person to receive, possess, deliver, use or transfer source or radioactive material.

C. Depleted uranium in industrial products and devices.

1. A general license is hereby issued to receive, acquire, possess, use or transfer, in accordance with the provisions of subdivisions 2, 3, 4, and 5 of this subsection, depleted uranium contained in industrial products or devices for the purpose of providing a concentrated mass in a small volume of the product or device.

2. The general license in subdivision 1 of this subsection applies only to industrial products or devices that have been manufactured or initially transferred in accordance with a specific license issued by the agency, the NRC, or another agreement state, which authorizes manufacture of the products or devices for distribution to persons generally licensed.

3. Persons who receive, acquire, possess, or use depleted uranium pursuant to the general license in subdivision 1 of this subsection shall file a registration form with the agency by an appropriate method. The form shall be submitted within 30 days after the first receipt or acquisition of such depleted uranium and the agency shall be notified, in writing, within 30 days, of any change afterwards. The registrant shall furnish the following information and such other information as may be required:

a. Name and address of the registrant;

b. A statement that the registrant has developed and will maintain procedures designed to establish physical control over the depleted uranium described in subdivision 1 of this subsection and designed to prevent transfer of such depleted uranium in any form, including metal scrap, to persons not authorized to receive the depleted uranium; and

c. Name, title, or both; address; and telephone number of the individual duly authorized to act for and on behalf of the registrant in supervising the procedures identified in this subdivision.

4. A person who receives, acquires, possesses, or uses depleted uranium pursuant to the general license established in subdivision 1 of this subsection:

a. Shall not introduce such depleted uranium, in any form, into a chemical, physical, or metallurgical treatment or process, except a treatment or process for repair or restoration of any plating or other covering of the depleted uranium.

b. Shall not abandon such depleted uranium.

c. Shall transfer or dispose of such depleted uranium only by transfer in accordance with 12VAC5-481-570. In the case where the transferee receives the depleted uranium pursuant to the general license established by subdivision 1 of this subsection, the transferor shall furnish the transferee a copy of this subsection and a copy of the appropriate agency form. In the case where the transferee receives the depleted uranium pursuant to a general license contained in a NRC or another agreement state's regulation equivalent to this subsection, the transferor shall furnish the transferee with a copy of this subsection and a copy of the appropriate agency form accompanied by a note explaining that use of the product or device is regulated by the NRC or agreement state under requirements substantially the same as those in this subsection.

d. Within 30 days of any transfer, shall report, in writing, to the agency the name and address of the person receiving the source material pursuant to such transfer.

5. Any person receiving, acquiring, possessing, using, or transferring depleted uranium pursuant to the general license established by subdivision 1 of this subsection is exempt from the requirements of Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of 12VAC5-481 with respect to the depleted uranium covered by that general license.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-421 Requirements for license to initially transfer source material for use under the small quantities of source material general license

A. An application for a specific license to initially transfer source material for use under 12VAC5-481-420 A or equivalent regulations of the NRC or another agreement state will be approved if:

1. The applicant satisfies the general requirements specified in 12VAC5-481-450; and

2. The applicant submits adequate information on, and the agency approves the methods to be used for quality control, labeling, and providing safety instructions to recipients.

B. Conditions of licenses to initially transfer source material for use under the small quantities of source material general license: quality control, labeling, safety instructions, and records and reports.

1. Each person licensed under subsection A of this section shall label the immediate container of each quantity of source material with the type of source material and quantity of material and the words, "radioactive material."

2. Each person licensed under subsection A of this section shall ensure that the quantities and concentrations of source material are as labeled and indicated in any transfer records.

3. Each person licensed under subsection A of this section shall provide the information specified in this subdivision to each person to whom source material is transferred for use under 12VAC5-481-420 A or equivalent provisions of the NRC or another agreement state. This information shall be transferred before the source material is transferred for the first time in each calendar year to the particular recipient. The required information includes:

a. A copy of 12VAC5-481-420 A and 12VAC5-481-570, or relevant equivalent regulations of the NRC or another agreement state.

b. Appropriate radiation safety precautions and instructions relating to handling, use, storage, and disposal of the material.

4. Each person licensed under subsection A of this section shall report transfers as follows:

a. File a report with the Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555. The report shall include the following information:

(1) The name, address, and license number of the person who transferred the source material;

(2) For each general licensee under 10 CFR 40.22 or equivalent agreement state provisions to whom greater than 50 grams (0.11 lb) of source material has been transferred in a single calendar quarter, the name and address of the general licensee to whom source material is distributed; a responsible agent, by name, position, or both and phone number, of the general licensee to whom the material was sent and the type, physical form, and quantity of source material transferred; and

(3) The total quantity of each type and physical form of source material transferred in the reporting period to all such generally licensed recipients.

b. File a report with the agency and other agreement state agencies that identifies all persons operating under provisions equivalent to 12VAC5-481-420 A to whom greater than 50 grams (0.11 lb) of source material has been transferred within a single calendar quarter. The report shall include the following information specific to those transfers made to the agreement state to which the report is being made:

(1) The name, address, and license number of the person who transferred the source material;

(2) The name and address of the general licensee to whom source material was distributed; a responsible agent, by name, position, or both and phone number, of the general licensee to whom the material was sent; and the type, physical form, and quantity of source material transferred; and

(3) The total quantity of each type and physical form of source material transferred in the reporting period to all such generally licensed recipients within the agreement state.

c. Submit each report by January 31 of each year covering all transfers for the previous calendar year. If no transfers were made to persons generally licensed under 12VAC5-481-420 A or equivalent NRC and other agreement state provisions during the current period, a report shall be submitted to the agency indicating so. If no transfers have been made to general licensees of the NRC or in a particular agreement state during the reporting period, this information shall be reported to the NRC or responsible agreement state agency upon request of the agency.

5. Each person licensed under subsection A of this section shall maintain all information that supports the reports required by this section concerning each transfer to a general licensee for a period of one year after the event is included in a report to the agency, the NRC, or another agreement state.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016; amended, Virginia Register Volume 33, Issue 11, eff. February 22, 2017; Volume 34, Issue 2, eff. October 18, 2017.

12VAC5-481-430 General licenses -- radioactive material other than source material

A. Certain devices and equipment.

1. A general license is hereby issued to transfer, receive, acquire, own, possess, and use radioactive material incorporated in the following devices or equipment that have been manufactured, tested, and labeled by the manufacturer in accordance with a specific license issued to the manufacturer by the agency or equivalent requirements by the NRC or another agreement state for use pursuant to 12VAC5-481-480 B or C.

a. Devices designed for use as static eliminators that contain, as a sealed source or sources, radioactive material consisting of a total not more than 500 μCi (18.5 MBq) of polonium-210 per device.

b. Devices designed for ionization of air that contain, as a sealed source or sources, radioactive material consisting of a total not more than 500 μCi (18.5 MBq) of polonium-210 per device or a total of not more than 50 mCi (1.85 GBq) of hydrogen-3 per device.

2. The general licenses provided in this subsection are subject to the general provisions of this subsection, the provisions of this part, and Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter unless indicated otherwise in the specific provision of the general license.

B. Certain detecting, measuring, gauging, or controlling devices and certain devices for producing light or an ionized atmosphere.

1. A general license is hereby issued to commercial and industrial firms and research, educational and medical institutions, individuals in the conduct of their business, and federal, state, or local government agencies to acquire, receive, possess, use, or transfer, in accordance with the provisions of subdivisions 2, 3, 4, 5, and 6 of this subsection, radioactive material, excluding special nuclear material, contained in devices designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing light or an ionized atmosphere.

2. The general license in subdivision 1 of this subsection applies only to radioactive material contained in devices which have been manufactured or initially transferred and labeled in accordance with the specifications contained in:

a. A specific license issued by the agency; or

b. An equivalent specific license issued by the NRC or another agreement state.

3. The devices shall have been received from one of the specific licensees described in this subsection or through a transfer made under subdivision 4 of this subsection.

4. Any person who owns, acquires, receives, possesses, uses, or transfers radioactive material in a device pursuant to the general license in subdivision 1 of this subsection:

a. Shall assure that all labels affixed to the device at the time of receipt and bearing a statement that removal of the label is prohibited are maintained thereon and shall comply with all instructions and precautions provided by such labels.

b. Shall assure that the device is tested for leakage of radioactive material and proper operation of the on-off mechanism and indicator, if any, at no longer than six-month intervals or at such other intervals as are specified in the label; however:

(1) Devices containing only krypton need not be tested for leakage of radioactive material; and

(2) Devices containing only tritium or not more than 100 μCi (3.7 MBq) of other beta or gamma emitting material or 10 μCi (0.37 MBq) of alpha emitting material and devices held in storage in the original shipping container prior to initial installation need not be tested for any purpose.

c. Shall assure that the tests required by subdivision 4 of this subsection and other testing, installation, servicing, and removal from installation involving the radioactive materials, its shielding or containment, are performed:

(1) In accordance with the instructions provided by the labels; or

(2) By a person holding a specific license issued by the agency, the NRC, or another agreement state to perform such activities.

d. Shall maintain records showing compliance with the requirements of subdivision 4 of this subsection. The records shall show the results of tests. The records also shall show the dates of performance of, and the names of persons performing, testing, installing, servicing, and removing from the installation radioactive material and its shielding or containment. The licensee shall retain these records as follows:

(1) Each record of a test for leakage or radioactive material required by subdivision 4 of this subsection shall be retained for three years after the next required leak test is performed or until the sealed source is transferred or disposed of.

(2) Each record of a test of the on-off mechanism and indicator required by subdivision 4 of this subsection shall be retained for three years after the next required test of the on-off mechanism and indicator is performed or until the sealed source is transferred or disposed of.

(3) Each record that is required by subdivision 4 of this subsection shall be retained for three years from the date of the recorded event or until the device is transferred or disposed of.

e. Shall immediately suspend operation of the device if there is a failure of, damage to, or any indication of a possible failure of or damage to, the shielding of the radioactive material or the on-off mechanism or indicator, or upon the detection of 0.005 μCi (185 Bq) or more removable radioactive material. The device may not be operated until it has been repaired by the manufacturer or other person holding a specific license to repair such devices that was issued by the agency, NRC, or another agreement state. The device and any radioactive material from the device may only be disposed of by transfer to a person authorized by a specific license to receive the radioactive material in the device or as otherwise approved by the agency. A report containing a brief description of the event and the remedial action taken; and, in the case of detection of 0.005 μCi (185 Bq) or more removable radioactive material or failure of or damage to a source likely to result in contamination of the premises or the environs, a plan for ensuring that the premises and environs are acceptable for unrestricted use, shall be furnished to the agency within 30 days. Under these circumstances, the criteria set out in 12VAC5-481-1161 may be applicable, as determined by the agency on a case-by-case basis.

f. Shall not abandon the device containing radioactive material.

g. Shall not export the device containing radioactive material except in accordance with applicable provisions of this chapter.

h. Shall transfer or dispose of the device containing radioactive material only by export as provided by subdivision 4 g of this subsection, by transfer to another general licensee as authorized in subdivision 4 i of this subsection, or to a person authorized to receive the device by a specific license issued by the agency, the NRC, or another agreement state that authorizes waste collection or as otherwise approved under the following provisions of this subdivision B 4 h:

(1) Within 30 days after the transfer of a device to a specific licensee or export, furnish a report to the agency with the following information:

(a) The identification of the device by manufacturer's or initial transferor's name, model number, and serial number;

(b) The name, address, and license number of the person receiving the device (license number not applicable if exported); and

(c) The date of the transfer; and

(2) Obtain written agency approval before transferring the device to any other specific licensee not specifically identified in this subdivision; however, a holder of a specific license may transfer a device for possession and use under its own specific license without prior approval if the holder:

(a) Verifies that the specific license authorizes the possession and use, or applies for and obtains an amendment to the license authorizing the possession and use;

(b) Removes, alters, covers, or clearly and unambiguously augments the existing label (otherwise required by subdivision 4 of this subsection) so that the device is labeled in compliance with 12VAC5-481-880; however, the manufacturer, model number, and serial number shall be retained;

(c) Obtains the manufacturer's or initial transferor's information concerning maintenance that would be applicable under the specific license (e.g., as leak testing procedures); and

(d) Reports the transfer under subdivision 4 of this subsection.

i. Shall transfer the device to another general licensee only if:

(1) The device remains in use at a particular location. In this case, the transferor shall give the transferee a copy of this subsection, a copy of this part and 12VAC5-481-1090 and 12VAC5-481-1100, and any safety documents identified in the label of the device. Within 30 days of the transfer, the transferor shall report to the agency:

(a) The manufacturer's or initial transferor's name;

(b) The model number and the serial number of the device transferred;

(c) The transferee's name and mailing address for the location of use; and

(d) The name, title, and phone number of the responsible individual identified by the transferee in accordance with subdivision 4 l of this subsection to have knowledge of and authority to take actions to ensure compliance with the appropriate regulations and requirements; or

(2) The device is held in storage by an intermediate person in the original shipping container at its intended location of use prior to initial use by a general licensee.

j. Shall comply with the provisions of 12VAC5-481-1090 and 12VAC5-481-1100 for reporting radiation incidents, theft, or loss of licensed material, but shall be exempt from the other requirements of Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter.

k. Shall respond to written requests from the agency to provide information relating to the general license within 30 calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by providing the agency a written justification for the request.

l. Shall appoint an individual responsible for having knowledge of the appropriate regulations and requirements and the authority for taking required actions to comply with appropriate regulations and requirements. The general licensee, through this individual, shall ensure the day-to-day compliance with appropriate regulations and requirements. This appointment does not relieve the general licensee of any of its responsibility in this regard.

m. Shall annually register devices containing at least 10 mCi (370 MBq) of cesium-137, 0.1 mCi (3.7 MBq) of strontium-90, 1 mCi (37 MBq) of cobalt-60, 0.1 mCi (3.7 MBq) of radium-226, or 1 mCi (37 MBq) of americium-241 or any other transuranic (i.e., element with atomic number greater than uranium (92)), based on the activity indicated on the label. Each address for a location of use represents a separate general licensee and requires a separate registration and fee. The registration fee will be $50 per device.

(1) The registration information shall be submitted to the agency within 30 days of the requested date for registration or as otherwise indicated in the request, and at a minimum include the following information and any other information specifically requested by the agency:

(a) Name and mailing address of the general licensee.

(b) Information about each device, including the manufacturer or initial transferor, model number, serial number, the radioisotope and activity (as indicated on the label).

(c) Name, title, and telephone number of the responsible person designated as a representative of the general licensee under subdivision 4 l of this subsection.

(d) Address or location at which the device or devices are used or stored. For portable devices, the address of the primary place of storage.

(e) Certification by the responsible representative of the general licensee that the information concerning the device or devices has been verified through a physical inventory and checking of label information.

(f) Certification by the responsible representative of the general licensee that they are aware of the requirements of the general license.

(2) A general licensee holding devices meeting the criteria of subdivision 4 m of this subsection is subject to the bankruptcy notification requirement in 12VAC5-481-500 E.

n. Shall report changes to the mailing address for the location of use, including change in name of general licensee, to the agency within 30 days of the effective date of the change. For a portable device, a report of address change is only required for a change in the device's primary place of storage of the device.

o. May not hold devices that are not in use for longer than two years. If devices with shutters are not being used, the shutter shall be locked in the closed position. The testing required by subdivision 4 of this subsection need not be performed during the period of storage only. However, when devices are put back into service or transferred to another person and have not been tested within the required test interval they shall be tested for leakage before use or transfer and the shutter tested before use. Devices kept in standby for future use are excluded from the two-year time limit if the general licensee performs quarterly physical inventories of these devices while they are in standby.

5. The general license in this subsection does not authorize the manufacture or import of devices containing radioactive material.

6. The general license provided in this subsection is subject to the provisions of this part and Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter unless indicated otherwise in the specific provision of the general license.

C. The general license provided in 12VAC5-481-420 B is subject to the provisions of 12VAC5-481-100 through 12VAC5-481-210, 12VAC5-481-500, 12VAC5-481-570, 12VAC5-481-580 and Part XIII (12VAC5-481-2950 et seq.) of this chapter.

D. Luminous safety devices for use in aircraft. In addition, this general license is subject to the provisions of 12VAC5-481-100 through 12VAC5-481-210, 12VAC5-481-500, 12VAC5-481-570, 12VAC5-481-580, and Part XIII (12VAC5-481-2950 et seq.) of this chapter.

1. A general license is hereby issued to own, receive, acquire, possess, and use tritium or promethium-147 contained in luminous safety devices for use in aircraft, provided each device contains not more than 10 Ci (370 GBq) of tritium or 300 mCi (11.1 GBq) of promethium-147 and that each device has been manufactured, assembled, or initially transferred in accordance with a license issued under the provisions of 12VAC5-481-480 D or manufactured or assembled in accordance with a specific license issued by the NRC or another agreement state that authorizes manufacture or assembly of the device for distribution to persons generally licensed the agency or NRC.

2. Persons who own, receive, acquire, possess or use luminous safety devices pursuant to the general license in this subdivision are exempt from the requirements of Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter, except that they shall comply with the provisions of 12VAC5-481-1090 and 12VAC5-481-1100.

3. This general license does not authorize the manufacture, assembly, repair, or import of luminous safety devices containing tritium or promethium-147.

4. This general license does not authorize the export of luminous safety devices containing tritium or promethium-147.

5. This general license does not authorize the ownership, receipt, acquisition, possession, or use of promethium-147 contained in instrument dials.

6. The general license provided in this subsection is subject to the general provisions of this subsection, the provisions of this part, and Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter unless indicated otherwise in the specific provision of the general license.

E. General license to own radioactive material.

1. A general license is hereby issued to own radioactive material without regard to quantity. Notwithstanding any other provision of this subsection, a general license under this subsection is not authorized to manufacture, produce, transfer, receive, possess, use, import, or export radioactive material, except as authorized in a specific license.

2. A general license is hereby issued to receive title to and own special nuclear material without regard to quantity. Notwithstanding any other provision of this subsection, a general license under this subsection is not authorized to acquire, deliver, receive, possess, use, transfer, import, or export special nuclear material, except as authorized in a specific license.

3. The general license provided in this subsection is subject to the general provisions of this subsection, the provisions of this part, and Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter unless indicated otherwise in the specific provision of the general license.

F. Calibration and reference sources.

1. A general license is hereby issued to own, receive, acquire, possess, use, and transfer americium-241 in the form of calibration or reference sources in accordance with the provisions of subdivisions 4 and 5 of this subsection to any person who holds a specific license issued by the agency that authorizes receipt, possession, use, and transfer of radioactive material.

2. A general license is hereby issued to own, receive, possess, use, and transfer plutonium in the form of calibration or reference sources in accordance with the provisions of subdivisions 4 and 5 of this subsection to any person who holds a specific license issued by the agency that authorizes him to receive, possess, use, and transfer radioactive material.

3. A general license is hereby issued to own, receive, possess, use, and transfer radium-226 in the form of calibration or reference sources in accordance with the provisions of subdivisions 4 and 5 of this subsection to any person who holds a specific license issued by the agency which authorizes him to receive, possess, use, and transfer radioactive material.

4. The general licenses in subdivisions 1 through 3 of this subsection apply only to calibration or reference sources that have been manufactured in accordance with the specifications contained in a specific license issued to the manufacturer or importer of the sources by the NRC pursuant to 10 CFR 32.57 or 10 CFR 70.39, or that have been manufactured in accordance with the specifications contained in a specific license issued to the manufacturer by the agency or another agreement state pursuant to licensing requirements equivalent to those contained in 10 CFR 32.57 or 10 CFR Part 70.39.

5. The general licenses provided in subdivisions 1 through 3 of this subsection are subject to the provisions of 12VAC5-481-100 through 12VAC5-481-210, 12VAC5-481-500, 12VAC5-481-570, 12VAC5-481-580 and Parts IV (12VAC5-481-600 et seq.); X (12VAC5-481-2250 et seq.); and XIII (12VAC5-481-2950 et seq.) of this chapter. In addition, persons who own, receive, acquire, possess, use, or transfer one or more calibration or reference sources pursuant to these general licenses:

a. Shall not possess at any one time, at any one location of storage or use, more than 5 μCi (185 kBq) of americium-241, plutonium, or radium-226 in such sources;

b. Shall not receive, possess, use, or transfer such source unless the source, or the storage container, bears a label that includes one of the following statements, as appropriate, or a substantially similar statement that contains the information called for in one of the following statements, as appropriate:

(1) The receipt, possession, use, and transfer of this source, Model __________, Serial No. __________, are subject to a general license and the regulations of the Nuclear Regulatory Commission or of a state with which the Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label.

CAUTION—RADIOACTIVE MATERIAL

THIS SOURCE CONTAINS (AMERICIUM-241).

(PLUTONIUM) (Showing only the name of the appropriate material.)

DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.

____________________Name of manufacturer or importer

(2) The receipt, possession, use, and transfer of this source, Model __________, Serial No. __________, are subject to a general license and the regulations of a licensing state. Do not remove this label.

CAUTION—RADIOACTIVE MATERIAL

THIS SOURCE CONTAINS RADIUM-226.

DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.

____________________Name of manufacturer or importer

c. Shall not transfer, abandon, or dispose of such source except by transfer to a person authorized by a license from the agency, the NRC, or another agreement state to receive the source;

d. Shall store such source, except when the source is being used, in a closed container adequately designed and constructed to contain americium-241, plutonium, or radium-226 that might otherwise escape during storage; and

e. Shall not use such source for any purpose other than the calibration of radiation detectors or the standardization of other sources.

6. These general licenses do not authorize the manufacture of calibration or reference sources containing americium-241, plutonium, or radium-226.

7. This general license does not authorize the export of calibration or reference sources containing americium-241, plutonium, or radium-226.

8. The general license provided in this subsection is subject to the general provisions of this subsection and Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter unless indicated otherwise in the specific provision of the general license.

G. General license for use of radioactive material for certain in vitro clinical or laboratory testing.

1. A general license is hereby issued to any physician, veterinarian in the practice of veterinary medicine, clinical laboratory, or hospital to receive, acquire, possess, transfer, or use for any of the following stated tests in accordance with the provisions of this subsection the following radioactive materials in prepackaged units for use in-vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals:

a. Iodine-125, in units not exceeding 10 μCi (370 kBq) each.

b. Iodine-131, in units not exceeding 10 μCi (370 kBq) each.

c. Carbon-14, in units not exceeding 10 μCi (370 kBq) each.

d. Hydrogen-3 (tritium), in units not exceeding 50 μCi (1.85 MBq) each.

e. Iron-59, in units not exceeding 20 μCi (740 kBq) each.

f. Selenium-75, in units not exceeding 10 μCi (370 kBq) each.

g. Mock Iodine-125 reference or calibration sources, in units not exceeding 0.05 μCi (1.85 kBq) of iodine-129 and 0.005 μCi (185 Bq) of americium-241 each.

h. Cobalt-57, in units not exceeding 10 μCi (0.37 MBq) each.

2. A person shall not receive, acquire, possess, use, or transfer radioactive material under the general license established by subdivision 1 of this subsection unless that person:

a. Has filed the In Vitro Testing GL form with the agency and has received from the agency a validated copy with a registration number assigned. The physician, veterinarian, clinical laboratory, or hospital shall furnish the name and address of the physician, veterinarian, clinical laboratory, or hospital; the location of use; and a statement that the physician, veterinarian, clinical laboratory, or hospital has appropriate radiation measuring instruments to carry out in-vitro clinical or laboratory tests with radioactive material as authorized by this subsection and that such tests will be performed only by personnel competent in the use of such instruments and in the handling of the radioactive material; or

b. Has a license that authorizes the medical use of radioactive material that was issued under Part VII (12VAC5-481-1660 et seq.) of 12VAC5-481.

3. A person who receives, acquires, possesses, or uses radioactive material pursuant to the general license established by subdivision 1 of this subsection shall comply with the following:

a. The general licensee shall not possess at any one time under the general license in subdivision 1 of this subsection at any one location of storage or use, a total amount of iodine-125, iodine-131, selenium-75, cobalt-57, or iron-59 in excess of 200 μCi (7.4 MBq).

b. The general licensee shall store the radioactive material, until used, in the original shipping container or in a container providing equivalent radiation protection.

c. The general licensee shall use the radioactive material only for the uses authorized by subdivision 1 of this subsection.

d. The general licensee shall not transfer the radioactive material except by transfer to a person authorized to receive it by a license pursuant to this chapter, nor transfer the radioactive material in any manner other than in the unopened, labeled shipping container as received from the supplier.

e. The general licensee shall dispose of the Mock Iodine-125 reference or calibration sources described in this subsection as required by 12VAC5-481-910.

4. The general licensee shall not receive, acquire, possess, or use radioactive material pursuant to subdivision 1 of this subsection:

a. Except as prepackaged units which are labeled in accordance with the provisions of a specific license issued under the provisions of 12VAC5-481-480 G or in accordance with the provisions of a specific license issued by the NRC or another agreement state that authorizes the manufacture and distribution of iodine-125, iodine-131, carbon-14, hydrogen-3 (tritium), selenium-75, iron-59, cobalt-57, or Mock Iodine-125 for distribution to persons generally licensed, and

b. Unless the following statement, or a substantially similar statement that contains the information called for in the following statement, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure that accompanies the package:

"This radioactive material may be received, acquired, possessed, and used only by physicians or veterinarians in the practice of veterinary medicine, clinical laboratories, or hospitals and only for in-vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the U.S. Nuclear Regulatory Commission or of a state with which the Commission has entered into an agreement for the exercise of regulatory authority.

(Name of Manufacturer)"

5. The registrant possessing or using radioactive materials under the general license of subdivision 1 of this subsection shall report in writing to the agency, any changes in the information furnished to the agency in the Registration Certificate – In Vitro Testing With Radioactive Material Under General License within 30 days after the effective date of such change.

6. Any person using radioactive material pursuant to the general license of subdivision 1 of this subsection is exempt from the requirements of Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter with respect to radioactive materials covered by that general license, except that such persons using the Mock Iodine-125 described in subdivision 1 of this subsection shall comply with the provisions of 12VAC5-481-910, 12VAC5-481-1090, and 12VAC5-481-1100.

7. The general license provided in this subsection is subject to the provisions of this part and Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter unless indicated otherwise in the specific provision of the general license.

H. Strontium-90 in ice detection devices.

1. A general license is hereby issued to own, receive, acquire, possess, use, and transfer strontium-90 contained in ice detection devices, provided each device contains not more than 50 μCi (1.85 MBq) of strontium-90 and each device has been manufactured or initially transferred in accordance with the specifications contained in a license issued pursuant to 12VAC5-481-480 H or in accordance with the specifications contained in a specific license issued to the manufacturer by the NRC or another agreement state authorizing manufacture of the ice detection devices for distribution to persons generally licensed.

2. Persons who own, receive, acquire, possess, use, or transfer strontium-90 contained in ice detection devices pursuant to the general license in subdivision 1 of this subsection:

a. Shall, upon occurrence of visually observable damage, such as a bend or crack or discoloration from overheating, to the device, (i) discontinue use of the device until it has been inspected, tested for leakage, and repaired by a person holding a specific license pursuant to this part or Part IV (12VAC5-481-600 et seq.) of this chapter, or from the NRC or another agreement state to manufacture or service such devices; or (ii) dispose of the device pursuant to the provisions of 12VAC5-481-910.

b. Shall assure that all labels affixed to the device at the time of receipt, and that bear a statement that prohibits removal of the labels, are maintained thereon.

c. Are exempt from the requirements of Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter except that such persons shall comply with the provisions of 12VAC5-481-910, 12VAC5-481-1090, and 12VAC5-481-1100.

3. The general license does not authorize the manufacture, assembly, disassembly, repair, or import of strontium-90 in ice detection devices.

4. The general license provided in this subsection is subject to the provisions of this part, and Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter unless indicated otherwise in the specific provision of the general license.

I. Certain items and self-luminous products containing radium-226.

1. A general license is hereby issued to any person to acquire, receive, possess, use, or transfer in accordance with the provisions of the following subdivisions radium-226 contained in the following products manufactured prior to November 30, 2007.

a. Antiquities originally intended for use by the general public. For the purposes of this subsection, "antiquities" mean products originally intended for use by the general public and distributed in the late 19th and early 20th centuries, such as radium emanator jars, revigators, radium water jars, radon generators, refrigerator cards, radium bath salts, and healing pads.

b. Intact timepieces containing greater than 1 μCi (0.037 MBq), nonintact timepieces, and timepiece hands and dials no longer installed in timepieces.

c. Luminous items installed in air, marine, or land vehicles.

d. All other luminous products, provided that no more than 100 items are used or stored at the same location at any one time.

e. Small radium sources containing no more than 1 μCi (0.037 MBq) of radium-226. For the purposes of this subsection, "small radium sources" means discrete survey instrument check sources, sources contained in radiation measuring instruments, sources used in educational demonstrations (such as cloud chambers and spinthariscopes), electron tubes, lightning rods, ionization sources, static eliminators, or as designated by the NRC.

2. Persons who acquire, receive, possess, use, or transfer radioactive material under the general license issued in subdivision 1 of this subsection are exempt from the provisions of Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter, as well as 12VAC5-481-1090 and 12VAC5-481-1100, to the extent that the receipt, possession, use, or transfer of radioactive material is within the terms of the general license; provided, however, that this exemption shall not be deemed to apply to any such person specifically licensed.

3. Any person who acquires, receives, possesses, uses, or transfers radioactive material in accordance with the general license in subdivision 1 of this subsection:

a. Shall notify the agency should there be any indication of possible damage to the product so that it appears it could result in a loss of the radioactive material. A report containing a brief description of the event and the remedial action taken shall be furnished to the agency within 30 days.

b. Shall not abandon products containing radium-226. The product, and any radioactive material from the product, may only be disposed of according to 12VAC5-481-971 or by transfer to a person authorized by a specific license to receive the radium-226 in the product or as otherwise approved by the agency.

c. Shall not export products containing radium-226 except in accordance with this chapter.

d. Shall dispose of products containing radium-226 at a disposal facility authorized to dispose of radioactive material in accordance with any federal or state solid or hazardous waste law, including the Solid Waste Disposal Act (42 USC § 6901 et seq.), as authorized under the Energy Policy Act of 2005 (42 USC § 15801 et seq.), by transfer to a person authorized to receive radium-226 by a specific license issued under this part or equivalent regulations of the NRC or another agreement state, or as otherwise approved by the agency.

e. Shall respond to written requests from the agency to provide information relating to the general license within 30 calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by providing the agency a written justification for the request.

4. The general license in subdivision 1 of this subsection does not authorize the manufacture, assembly, disassembly, repair, or import of products containing radium-226, except that timepieces may be disassembled and repaired.

5. The general license provided in this subsection is subject to the general provisions of this subsection, the provisions of this part, and Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter unless indicated otherwise in the specific provision of the general license.

J. General license to install and service generally licensed devices. Any person who holds a specific license issued by the NRC or another agreement state authorizing the holder to manufacture, install, or service a device described in this subsection, is hereby granted a general license to install and perform nonradiological service (i.e., leak testing, surveys, routine maintenance) of the devices, provided that:

1. The device has been manufactured, labeled, installed, and serviced in accordance with applicable provisions of the specific license issued to such person by the NRC or another agreement state; and

2. Such person assures that any labels required to be affixed to the device under regulations of the NRC or another agreement state licensing the manufacture of the device bear a statement that removal of the label is prohibited.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

Article 4 Specific Licenses

12VAC5-481-440 Filing application for specific licenses

A. Applications for specific licenses shall be filed on a form prescribed by the agency.

B. The agency may at any time after the filing of the original application, and before the expiration of the license, require further statements in order to enable the agency to determine whether the application should be granted or denied or whether a license should be modified or revoked.

C. Each application shall be signed by the applicant or licensee or a person duly authorized to act for and on his behalf.

D. An application for a license may include a request for a license authorizing one or more activities.

E. Applications and documents submitted to the agency may be made available for public inspection in accordance with the Virginia Freedom of Information Act (§ 2.2-3700 et seq. of the Code of Virginia). The agency may withhold records in accordance with specific exemptions in the Virginia Freedom of Information Act or as otherwise specified by law.

F. An application for a specific license to use radioactive material in the form of a sealed source or in a device that contains the sealed source shall either:

1. Identify the source or device by manufacturer and model number as registered with the NRC under 10 CFR 32.210 or an Agreement state under equivalent regulations;

2. Contain the information in 10 CFR 32.210(c);

3. For sources or devices containing radioactive material manufactured prior to October 23, 2012, that are not registered with the NRC under 10 CFR 32.210 or with an Agreement state, and for which the applicant is unable to provide all categories of information specified in 10 CFR 32.210(c), the applicant shall provide:

a. All available information identified in 10 CFR 32.210(c) concerning the source, and, if applicable, the device; and

b. Sufficient additional information to demonstrate that there is reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property. Such information shall include a description of the source or device, a description of radiation safety features, the intended use and associated operating experience, and the results of a recent leak test;

4. For sealed sources and devices allowed to be distributed without registration of safety information in accordance with 10 CFR 32.210(g)(1), the applicant may supply only the manufacturer, model number, and radionuclide and quantity; or

5. If it is not feasible to identify each sealed source and device individually, the applicant may propose constraints on the number and type of sealed sources and devices to be used and the conditions under which they will be used in lieu of identifying each sealed source and device.

G. Each application to possess radioactive material in unsealed form, on a foil or plated source, or sealed in glass in excess of the quantities in 12VAC5-481-3740 shall contain one of the following:

1. An evaluation showing that the projected dose to a person offsite due to a release of radioactive material would not exceed 0.01 Sv (1 rem) total effective dose equivalent or 0.05 Sv (5 rem) to the thyroid; or

2. An emergency plan, reviewed and commented on by offsite response organizations expected to respond in the event of an accident that contains the following information:

a. Facility description. A brief description of the licensee or applicant's facility and surroundings.

b. Types of accidents. An identification of each type of radioactive materials accident for which actions by licensee staff or offsite response organizations will be needed to protect members of the public.

c. Classification of accidents. A method for classifying and declaring an accident as alert or site area emergency.

d. Detection of accidents. Identification of the means for detecting each type of alert or site area emergency in a timely manner.

e. Mitigation of consequences. A brief description of the means and equipment that are available for mitigating the consequences of each type of accident, including those provided to protect workers onsite, and a description of the program for maintaining the equipment.

f. Assessment of releases. A brief description of the methods and equipment available to assess releases of radioactive material.

g. Responsibilities. A brief description of the responsibilities of the licensee or applicant's personnel who will respond if an accident occurs, including identification of personnel responsible for promptly notifying offsite response organizations, including the agency.

h. Plan maintenance. A brief description of the positions assigned and methods to develop, maintain and update the plan.

i. A list of offsite response organizations, description of their responsibilities and anticipated actions, and copy of formal commitments, if any.

j. Notification and coordination. A brief description of the means to promptly notify the offsite response organizations and request offsite assistance including medical assistance for the treatment of contaminated injured onsite workers. The notification and coordination shall include alternate provisions in case key personnel, parts of the facility, or some equipment are unavailable. The licensee shall also commit to notify the agency immediately after notification of the appropriate offsite response organizations and not later than one hour after the licensee declares an emergency.

k. Information to be communicated. A brief description of the types of information on facility status, radioactive releases and recommended protective actions, if necessary, to be given to offsite response organizations and the agency. A licensee shall allow the offsite response organizations expected to respond in case of an accident 60 days to comment on the licensees emergency plan before submitting it to the agency. A licensee shall provide any comments received within the 60 days to the agency with the emergency plan.

l. Training. A brief description of the frequency, performance objectives and plan for training that the licensee or applicant will provide workers on how to respond to an emergency, including any special instructions and orientation tours that the licensee or applicant will offer to fire, police, medical and other emergency personnel. The training shall familiarize personnel with site-specific hazards and emergency procedures. The training shall also prepare site personnel for their responsibilities in the event of accident scenarios postulated as most probable for the specific site, including the use of drills, exercises and team training for such scenarios.

m. Drills and exercises. Provisions for conducting quarterly communications checks with offsite response organizations and biennial onsite exercises to test response to simulated emergencies. The licensee or applicant shall invite offsite response organizations to participate in biennial exercises. The exercises shall use accident scenarios postulated as the most probable for the specific site and the scenarios may not be known to most exercise participants. Critiques of exercises shall evaluate the appropriateness of the plan, emergency procedures, facilities, equipment, training of personnel and overall effectiveness of the response. Deficiencies found by the critiques shall be corrected.

n. Safe condition. A brief description of the means of restoring the facility and surroundings to a safe condition after an accident.

o. Hazardous chemicals. A certification that the applicant has met its responsibilities under the Emergency Planning and Community Right-To-Know Act of 1986, Title III, P.L. 99-499, if applicable to the applicant's activities at the proposed place of use of the radioactive material.

H. An application from a medical facility or educational institution to produce PET radioactive drugs for noncommercial transfer to licensees in its consortium authorized for medical use under Part VII (12VAC5-481-1660 et seq.) of this chapter shall include:

1. A request for authorization for the production of PET radionuclides or evidence of an existing license issued under Part III (12VAC5-481-380 et seq.) of this chapter for a PET radionuclide production facility within its consortium from which it receives PET radionuclides.

2. Evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one of the criteria in 12VAC5-481-480 I.

3. Identification of individual(s) authorized to prepare the PET radioactive drugs if the applicant is a pharmacy, and documentation that each individual meets the requirements of an ANP as specified in 12VAC5-481-480 I 2.

4. Information identified in 12VAC5-481-480 I 1 c on the PET drugs to be noncommercially transferred to members of its consortium.

I. Manufacture, preparation, or transfer for commercial distribution of drugs containing radioactive material for medical use under Part VII (12VAC5-481-1660 et seq.).

1. An application for a specific license to manufacture, prepare, or transfer for commercial distribution drugs containing radioactive material for use by persons authorized pursuant to Part VII (12VAC5-481-1660 et seq.) will be approved if:

a. The applicant satisfies the general requirements specified in 12VAC5-481-450;

b. The applicant submits evidence that the applicant is at least one of the following:

(1) Registered or licensed with the U.S. Food and Drug Administration (FDA) as a drug manufacturer;

(2) Registered or licensed with a state agency as a drug manufacturer;

(3) Licensed as a pharmacy by the Virginia Board of Pharmacy;

(4) Operating as a nuclear pharmacy within a federal medical institution; or

(5) A PET drug production facility registered with a state agency.

c. The applicant submits information on the radionuclide; the chemical and physical form; the maximum activity per vial, syringe, generator, or other container of the radioactive drug; and the shielding provided by the packaging to show it is appropriate for the safe handling and storage of the radioactive drugs by medical use licensees; and

d. The applicant satisfies the following labeling requirements:

(1) A label is affixed to each transport radiation shield, whether it is constructed of lead, glass, plastic, or other material, of a radioactive drug to be transferred for commercial distribution. The label shall include the radiation symbol as described in 12VAC5-481-850 and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL"; the name of the radioactive drug or its abbreviation; and the quantity of radioactivity at a specified date and time. For radioactive drugs with a half-life greater than 100 days, the time may be omitted.

(2) A label is affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution. The label shall include the radiation symbol as described in 12VAC5-481-850 and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL" and an identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label.

2. A licensee authorized to manufacture, prepare or transfer for commercial distribution radioactive drugs shall ensure that any individual preparing the drugs is one of the following:

a. An authorized nuclear pharmacist (ANP) as defined in 12VAC5-481-10;

b. An individual that meets the requirements specified in 12VAC5-481-1770 and 12VAC5-481-1790, and the licensee has received an approved license amendment identifying this individual as an ANP;

c. A pharmacist, as defined in 12VAC5-481-10, designated as an ANP if:

(1) The individual was a nuclear pharmacist preparing only radioactive drugs containing accelerator-produced radioactive material; and

(2) The individual practiced at a pharmacy at a government agency or federally recognized Indian Tribe before November 30, 2007, or at all other pharmacies before August 8, 2009, or an earlier date as noticed by the NRC; or

d. An individual under the supervision of an ANP as specified in 12VAC5-481-1710.

3. Shall provide to the agency no later than 30 days after the date that the licensee allows, under subdivision 2 a or c of this subsection, the individual to work as an ANP:

a. The individual's certification by a specialty board whose certification process has been recognized by the NRC with the written attestation signed by a preceptor as required by 12VAC5-481-1770;

b. An NRC or another Agreement state license;

c. NRC master materials licensee permit;

d. The permit issued by a licensee or NRC master materials permittee of broad scope or the authorization from a commercial nuclear pharmacy authorized to list its own authorized nuclear pharmacist; or

e. Documentation that only accelerator-produced radioactive materials were used in the practice of nuclear pharmacy at a government agency or federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC; and

f. The Virginia Board of Pharmacy's license.

4. A licensee shall possess and use instrumentation to measure the radioactivity of radioactive drugs. The licensee shall have procedures for use of the instrumentation. The licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha, beta, or photon-emitting radioactive drugs prior to transfer for commercial distribution. In addition, the licensee shall:

a. Perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument; and make adjustments when necessary; and

b. Check each instrument for constancy and proper operation at the beginning of each day of use.

5. Nothing in this subsection relieves the licensee from complying with applicable FDA, other federal, and state requirements governing radioactive drugs.

6. Each licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium-99m generators or rubidium-82 from strontium-82/ryubidium-82 generators shall test the generator eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85 contamination in accordance with 12VAC5-481-1930. The licensee shall record the results of each test and retain each record for three years after the record is made. The licensee shall report the results of any test that exceeds the permissible concentration listed in 12VAC5-481-1930 A at the time of the generator elution in accordance with 12VAC5-481-2080 D.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022.

12VAC5-481-450 General requirements for the issuance of specific licenses

A. A license application will be approved if the agency determines that:

1. The applicant is qualified by reason of training and experience to use the material in question for the purpose requested in accordance with these regulations in such a manner as to minimize danger to public health and safety or property;

2. The applicant's proposed equipment, facilities, and procedures are adequate to minimize danger to public health and safety or property;

3. The issuance of the license will not be inimical to the health and safety of the public;

4. The applicant has described in the application how facility design and procedures for operation will minimize, to the extent practicable, contamination of the facility and the environment, facilitate eventual decommissioning, and minimize, to the extent practicable, the generation of radioactive waste;

5. Licensees shall, to the extent practical, conduct operations to minimize the introduction of residual radioactivity into the site, including the subsurface, in accordance with this chapter; and

6.The applicant satisfies any applicable special requirements in 12VAC5-481-460, 12VAC5-481-470, 12VAC5-481-480, or Part V (12VAC5-481-1170 et seq.), Part VII (12VAC5-481-1660 et seq.), Part XI (12VAC5-481-2330 et seq.), Part XII (12VAC5-481-2660 et seq.), Part XIV (12VAC5-481-3140 et seq.), or Part XVI (12VAC5-281-3460 et seq.) of this chapter.

B. Environmental report, commencement of construction. In the case of an application for a license to receive and possess radioactive material for commercial waste disposal by land burial, or for the conduct of any other activity that the agency determines will significantly affect the quality of the environment, the agency, before commencement of construction of the plant or facility in which the activity will be conducted, has concluded, after weighing the environmental, economic, technical and other benefits against environmental costs and considering available alternatives, that the action called for is the issuance of the proposed license, with any appropriate conditions to protect environmental values. Commencement of construction prior to such conclusion shall be grounds for denial of a license to receive and possess radioactive material in such plant or facility. As used in this subsection the term "commencement of construction" means any clearing of land, excavation, or other substantial action that would adversely affect the environment of a site. The term does not mean site exploration, necessary roads for site exploration, borings to determine foundation conditions, or other preconstruction monitoring or testing to establish background information related to the suitability of the site or the protection of environmental values.

C. Financial assurance and records for decommissioning.

1. A person applying for a specific license authorizing the possession and use of unsealed radioactive material shall submit a decommissioning funding plan as described in subdivision 6 of this subsection with the license application for any of the following types of materials:

a. Unsealed radioactive material with a half-life greater than 120 days and in quantities greater than 10⁵ times the applicable quantities listed in 12VAC5-481-3750.

b. Unsealed radioactive material involving a combination of isotopes with R divided by 10⁵ being greater than one, where R is defined as the sum of the ratios of the quantity of each isotope to the applicable value in 12VAC5-481-3750.

2. A person applying for a specific license authorizing the possession and use of radioactive material not covered by subdivision 1 of this subsection with a half-life greater than 120 days and in quantities specified in subdivision 5 of this subsection shall do either of the following:

a. Submit a decommissioning funding plan as described in subdivision 6 of this subsection.

b. Submit a written certification, signed by the chief financial officer or other individual designated by management to represent the licensee, that financial assurance has been provided in the amount prescribed in subdivision 5 of this subsection using one of the methods described in subdivision 6 of this subsection and a signed original of the financial instrument obtained to satisfy the requirements of subdivision 7 of this subsection. The written certification may state that the appropriate assurance will be obtained after the application has been approved and the license issued by the agency but before receipt of radioactive material by the applicant. If the applicant defers execution of the financial instrument until after the license has been issued, the applicant shall submit to the agency a signed original of the financial instrument obtained before receipt of licensed material.

3. The following are exempt from the requirements of this subsection:

a. A state, local or other government agency, except for a government agency licensed to handle or process radioactive waste.

b. A person authorized to possess only radioactive materials with a half-life of 65 days or less.

c. Other persons exempted by the agency based on a review of the license application.

4. Implementation.

a. A person who possesses a specific license authorizing the possession and use of radioactive material issued on or after the effective date as stated in 12VAC5-481-160 that is of a type described in subdivision 1 of this subsection, shall provide financial assurance for decommissioning under this section.

b. A person who possesses a specific license issued before the effective date as stated in 12VAC5-481-160 shall do one of the following:

(1) For a license authorizing the use of radioactive material meeting the criteria of subdivision 1 of this subsection, submit a decommissioning funding plan as described in subdivision 6 of this subsection and a certification of financial assurance for at least $1,125,000, under the criteria in subdivision 5 of this subsection, with any application for license renewal.

(2) For a license authorizing the use of radioactive material meeting the criteria of subdivision 2 of this subsection, submit a decommissioning funding plan as described in subdivision 6 of this subsection or a certification of financial assurance for decommissioning according to the criteria of subdivision 5 of this subsection with any application for license renewal.

c. The term of the financial assurance shall be from the issuance or renewal of the license until the agency terminates the license.

d. A licensee's financial assurance arrangements may be reviewed annually by the agency to recognize any increases or decreases resulting from inflation or deflation, changes in engineering plans, activities performed or any other condition affecting costs for decommissioning to ensure that sufficient funding is available to cover liability that remains until license termination.

5. Required amounts for financial assurance.

a. A licensee shall provide the following minimum amounts of financial assurance for decommissioning, unless otherwise specified by the agency:

(1) $1,125,000 if the quantity of material is greater than 10⁴ but less than or equal to 10⁵ times the applicable quantities of 12VAC5-481-3750 in unsealed form. For a combination of isotopes, R divided by 10⁴ is greater than one but R divided by 10⁵ is less than or equal to one.

(2) $225,000 if the quantity of material is greater than 10³ but less than or equal to 10⁴ times the applicable quantities of 12VAC5-481-3750 in unsealed form. For a combination of isotopes, R divided by 10³ is greater than one but R divided by 10⁴ is less than or equal to one.

(3) $113,000 if the quantity of material is greater than 10¹⁰ times the applicable quantities of 12VAC5-481-3750 in sealed sources or plated foils. For a combination of isotopes, R divided by 10¹⁰ is greater than one.

b. The agency may eliminate, reduce or raise the required amount of financial assurance under subdivision 5 a of this subsection for an individual applicant or licensee based on the cost estimate for decommissioning included in the decommissioning funding plan required under subdivision 6 a of this subsection.

6. Each decommissioning funding plan (DFP) shall be submitted for review and approval by the agency.

a. The DFP shall include a detailed cost estimate for decommissioning, in an amount reflecting:

(1) The cost of an independent contractor to perform all decommissioning activities;

(2) The cost of meeting the criteria for unrestricted use in 12VAC5-481-1161 B provided that if the applicant or licensee can demonstrate its ability to meet the provisions of 12VAC5-481-1161 C, the cost estimate may be based on meeting the criteria in 12VAC5-481-1161 C;

(3) The volume of onsite subsurface material containing residual radioactivity that will require remediation to meet the criteria for license termination; and

(4) An adequate contingency factor;

b. The DFP shall include identification of and justification for using the key assumptions contained in the decommissioning cost estimate (DCE);

c. The DFP shall include a description of the method of assuring funds for decommissioning from subdivision 7 of this subsection, including means for adjusting cost estimates and associated funding levels periodically over the life of the facility;

d. The DFP shall include a certification by the licensee that financial assurance for decommissioning has been provided in the amount of the cost estimate for decommissioning;

e. The DFP shall include a signed original of the financial instrument obtained to satisfy the requirements of subdivision 7 of this subsection (unless a previously submitted and accepted financial instrument continues to cover the cost estimate for decommissioning); and

f. The DFP shall (i) be submitted with license renewal and at intervals not to exceed three years and (ii) contain adjustments as necessary to account for changes in costs and the extent of contamination. If the amount of financial assurance will be adjusted downward, this cannot be done until the updated decommissioning funding plan is approved. The DFP shall update the information submitted with the original or prior approved plan and shall specifically consider the effect of the following events on decommissioning costs:

(1) Spills of radioactive material producing additional residual radioactivity in onsite subsurface material;

(2) Waste inventory increasing above the amount previously estimated;

(3) Waste disposal costs increasing above the amount previously estimated;

(4) Facility modifications;

(5) Changes in authorized possession limits;

(6) Actual remediation costs that exceed the previous cost estimate;

(7) Onsite disposal; and

(8) Use of a settling pond.

7. A licensee may use any of the following methods to provide financial assurance for decommissioning:

a. Prepayment. Prepayment is the deposit prior to operation into an account segregated from licensee assets and outside the licensee's administrative control of cash or liquid assets in an amount sufficient to pay decommissioning costs. Prepayment may be in the form of a trust, escrow account, government fund, certificate of deposit or deposit of government securities. Funds placed into a trust segregated from the licensee's assets and outside the licensee's administrative control, and in which the adequacy of the trust funds is to be assessed based on an assumed annual 1.0% real rate of return on investment.

b. Surety method, insurance or other guarantee. Payment of future decommissioning costs shall be guaranteed by a surety method, insurance or other guarantee. A surety method may be in the form of a surety bond, letter of credit or line of credit. Self insurance, or any method that essentially constitutes self-insurance, may not be used as a method of providing financial assurance. Any surety method or insurance used to provide financial assurance for decommissioning shall meet all of the following criteria:

(1) The surety method or insurance shall be open-ended or, if written for a specified term, renewed automatically unless 90 days or more prior to the renewal date, the issuer notifies the agency, the beneficiary and the licensee of its intention not to renew. The surety method or insurance shall also provide that the full face amount be paid to the beneficiary automatically prior to the expiration without proof of forfeiture if the licensee fails to provide a replacement acceptable to the agency within 30 days after receipt of notification of cancellation.

(2) The surety method or insurance shall be payable to a trust established for decommissioning costs. The agency shall approve the trustee and the trust.

(3) The surety method or insurance shall remain in effect until the agency terminates the license.

c. External sinking fund. An external sinking fund may be used in which deposits are made at least annually, coupled with a surety method or insurance, the value of which may decrease by the amount being accumulated in the sinking fund. An external sinking fund may be in the form of a trust, escrow account, government fund, certificate of deposit or deposit of government securities. The surety or insurance provisions shall meet the requirements of subdivision 7 b of this subsection.

d. Statement of intent. A state or local government licensee exempt under subdivision 3 of this subsection shall submit a written statement of intent containing a cost estimate for decommissioning or an amount based on subdivision 5 of this subsection. The cost estimate shall indicate that funds for decommissioning will be obtained when necessary.

8. A licensee shall keep the following records of information related to decommissioning of a facility in an identified location until the site is released for unrestricted use:

a. Records of spills or other unusual occurrences involving the spread of radioactive contamination in and around the facility, equipment or site. The records may be limited to instances where contamination remains after any cleanup procedures or when there is reasonable likelihood that radioactive contaminants may have spread to inaccessible areas or into porous materials such as concrete. The records shall include any known information on identification of involved nuclides, quantities, forms and concentrations.

b. As-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used or stored, and of locations of possible inaccessible contamination such as buried pipes that may contain radioactive contaminants. If required drawings are referenced, each relevant document does not need to be indexed individually. If drawings are not available, a licensee shall substitute appropriate records of available information concerning the areas and locations of inaccessible contamination.

Note: As-built architectural and engineering drawings need to reflect the final details of the structures and equipment as they were constructed.

c. Except for areas containing only sealed sources that have not leaked or where no contamination remains after a leak, or byproduct materials with half-lives of less than 65 days, a list containing all the following:

(1) All areas currently and formerly designated as restricted areas.

(2) All areas outside of restricted areas that require documentation under subdivision 8 (c) 1 of this subsection.

(3) All areas outside of restricted areas where current and previous wastes have been buried as documented under 12VAC5-481-1060.

(4) All areas outside of restricted areas that contain radioactive material such that, if the license expired, the licensee would be required to either decontaminate the area to meet the criteria for decommissioning in 12VAC5-481-510 or apply for approval for disposal under 12VAC5-481-920.

d. Records of the cost estimate performed for the decommissioning funding plan or the amount certified for decommissioning and records of the funding method used for assuring funds.

9. A licensee shall keep the records in subdivision 8 of this subsection until the site is decommissioned and approved by the agency for unrestricted use.

10. Prior to a licensed activity being transferred to another licensee under 12VAC5-481-500 B, the original licensee shall transfer all records under subdivision 8 of this subsection to the new licensee. The new licensee shall be responsible for maintaining the records until their license is terminated by the agency.

11. A person applying for a specific license authorizing the possession and use of more than 100 mCi of source material in a readily dispersible form shall submit a decommissioning funding plan as described in subdivision 6 of this subsection.

12. A person applying for a specific license authorizing the possession and use of quantities of source material greater than 10 mCi but less than or equal to 100 mCi in a readily dispersible form shall either:

a. Submit a decommissioning funding plan as described in subdivision 6 of this subsection; or

b. Submit a certification that financial assurance for decommissioning has been provided in the amount of $225,000 using one of the methods described in subdivision 7 of this subsection.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 25, Issue 2, eff. November 1, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-451 Physical protection of Category 1 and Category 2 quantities of radioactive material

A. Any licensee who possesses or uses an aggregated quantity of Category 1 or Category 2 radioactive material equal to or in excess of those in subdivision 1 of this subsection shall establish a physical protection program that meets all requirements detailed in this section.

1. Radionuclides of concern.

| Radionuclide | Category 1 (TBq)^1,2 | Category 1 (Ci)^1,2 | Category 2 (TBq)^1,2 | Category 2 (Ci)^1,2 | | --- | --- | --- | --- | --- | | Am-241 | 60 | 1,620 | 0.6 | 16.2 | | Am-241/Be | 60 | 1,620 | 0.6 | 16.2 | | Cf-252 | 20 | 540 | 0.2 | 5.4 | | Cm-244 | 50 | 1,350 | 0.5 | 13.5 | | Co-60 | 30 | 810 | 0.3 | 8.1 | | Cs-137 | 100 | 2,700 | 1 | 27 | | Gd-153 | 1,000 | 27,000 | 10 | 270 | | Ir-192 | 80 | 2,160 | 0.8 | 21.6 | | Pm-147 | 40,000 | 1,080,000 | 400 | 10,800 | | Pu-238 | 60 | 1,620 | 0.6 | 16.2 | | Pu-239/Be | 60 | 1,620 | 0.6 | 16.2 | | Ra-226 | 40 | 1,080 | 0.4 | 10.8 | | Se-75 | 200 | 5,400 | 2 | 54 | | Sr-90 (Y-90) | 1,000 | 27,000 | 10 | 270 | | Tm-170 | 20,000 | 540,000 | 200 | 5,400 | | Yb-169 | 300 | 8,100 | 3 | 81 | | Combinations of radioactive materials listed in this table³ | | | See footnote 4 | | | ¹The aggregate activity of multiple, collocated sources of the same radionuclides should be included when the total activity equals or exceeds the Category 1 or Category 2 threshold. ²The primary values used for compliance are TBq. The curie (Ci) values are rounded to two significant figures for informational purposes only. ³Radioactive materials are to be considered aggregated or collocated if breaching a common physical barrier (e.g., a locked door at the entrance to a storage room) would allow access to the radioactive material or devices containing the radioactive material. ⁴If several radionuclides are aggregated, the sum of the ratios of the activity of each source, i of radionuclide, n, A (i,n), to the Category 1 or Category 2 threshold for radionuclide n, Q_n, listed for that radionuclide equals or exceeds one. [(aggregated source activity for radionuclide A) / (quantities of concern for radionuclide A)] + [(aggregated source activity for radionuclide B) / (quantities of concern for radionuclide B)] + etc…. greater to or equal than 1. | | | | |

2. A licensee that possesses radioactive waste that contains Category 1 or Category 2 quantities of radioactive material is exempt from the requirements of this section.

3. A licensee that possesses radioactive waste that contains discrete sources, ion-exchange resins, or activated material that weighs less than 2,000 kg (4,409 lbs) is not exempt from the requirements of this section. The licensee shall implement the following requirements to secure the radioactive waste:

a. Use continuous physical barriers that allow access to the radioactive waste only through established access control points;

b. Use a locked door or gate with monitored alarm at the access control point;

c. Assess and respond to each actual or attempted unauthorized access to determine whether an actual or attempted theft, sabotage, or diversion occurred; and

d. Immediately notify the local law-enforcement agency (LLEA) and request an armed response from the LLEA upon determination that there was an actual or attempted theft, sabotage, or diversion of the radioactive waste.

B. Background investigations and access authorization program.

1. Personnel access authorization requirements for Category 1 or Category 2 quantities of radioactive material.

a. Each licensee that possesses an aggregated quantity of radioactive material that equals or exceeds the Category 2 threshold shall establish, implement, and maintain its access authorization program in accordance with the requirements in this subsection. An applicant for a new license and each licensee that would become newly subject to the requirements in this subsection upon an amendment request of its license shall implement the requirements of this subsection, as appropriate, before taking possession of an aggregated quantity of radioactive material that equals or exceeds the Category 2 threshold. Any licensee that has not previously implemented the increased control requirements of this section shall implement the provisions of this subsection before aggregating radioactive material to a quantity that equals or exceeds the Category 2 threshold.

b. The licensee's access authorization program shall ensure that the individuals specified in subdivision 1 c of this subsection are trustworthy and reliable.

c. Licensees shall subject the following individuals to an access authorization program:

(1) Any individual whose assigned duties require unescorted access to Category 1 or Category 2 quantities of radioactive material; and

(2) Reviewing officials.

d. Licensees shall approve for unescorted access to Category 1 or Category 2 quantities of radioactive material only those individuals whose assigned job duties require unescorted access to Category 1 or Category 2 quantities of radioactive material.

e. Licensees need not subject the categories of individuals listed in subdivision 5 a of this subsection to the investigation elements of the access authorization program.

2. Access authorization program requirements.

a. Granting unescorted access authorization.

(1) Licensees shall implement the requirements of this subsection for granting initial or reinstated unescorted access authorization.

(2) Individuals who have been determined to be trustworthy and reliable shall also complete the security training required by subdivision C 2 c of this section before being allowed unescorted access to Category 1 or Category 2 quantities of radioactive material.

b. Reviewing officials.

(1) Reviewing officials are the only individuals who may make trustworthiness and reliability determinations that allow individuals to have unescorted access to Category 1 or Category 2 quantities of radioactive materials possessed by the licensee.

(2) Each licensee shall name one or more individuals to be reviewing officials. After completing the background investigation on the reviewing official, the licensee shall provide under oath or affirmation a certification that the reviewing official is deemed trustworthy and reliable by the licensee. Provide oath or affirmation certifications to the agency via an appropriate means listed in 12VAC5-481-150. The fingerprints of the named reviewing official shall be taken by a law-enforcement agency, a federal or state agency that provides fingerprinting services to the public, or a commercial fingerprinting service authorized by a state to take fingerprints. The licensee shall recertify that the reviewing official is deemed trustworthy and reliable every 10 years in accordance with subdivision 3 c of this subsection.

(3) Reviewing officials shall be permitted to have unescorted access to Category 1 or Category 2 quantities of radioactive material.

(4) Reviewing officials cannot approve other individuals to act as reviewing officials.

(5) A reviewing official does not need to undergo a new background investigation before being named by the licensee as the reviewing official if:

(a) The individual has undergone a background investigation that included fingerprinting and an FBI criminal history records check and has been determined to be trustworthy and reliable by the licensee; or

(b) The individual is subject to a category listed in subdivision 5 a of this subsection.

c. Informed consent.

(1) Licensees may not initiate a background investigation without the informed and signed consent of the subject individual. This consent shall include authorization to share personal information with other individuals or organizations as necessary to complete the background investigation. Before a final adverse determination, the licensee shall provide the individual with an opportunity to correct any inaccurate or incomplete information that is developed during the background investigation. Licensees do not need to obtain signed consent from those individuals who meet the requirements of subdivision 3 b of this subsection. A signed consent shall be obtained prior to any reinvestigation.

(2) The subject individual may withdraw his consent at any time. Licensees shall inform the individual that:

(a) If an individual withdraws his consent, the licensee may not initiate elements of the background investigation that were not in progress at the time the individual withdrew his consent; and

(b) The withdrawal of consent for the background investigation is sufficient cause of denial or termination of unescorted access authorization.

d. Any individual who is applying for unescorted access authorization shall disclose the personal history information that is required by the licensee's access authorization program for the reviewing official to make a determination of the individual's trustworthiness and reliability. Refusal to provide, or the falsification of, any personal history information required by this subsection is sufficient cause for denial or termination of unescorted access.

e. Determination basis.

(1) The reviewing official shall determine whether to permit, deny, unfavorably terminate, maintain, or administratively withdraw an individual's unescorted access authorization based on an evaluation of all the information collected to meet the requirements of this subsection.

(2) The reviewing official may not permit any individual to have unescorted access until the reviewing official has evaluated all the information collected to meet the requirements of this subsection and determined that the individual is trustworthy and reliable. The reviewing official may deny unescorted access to any individual based on information obtained at any time during the background investigation.

(3) The licensee shall document the basis for concluding whether or not there is reasonable assurance that an individual is trustworthy and reliable.

(4) The reviewing official may terminate or administratively withdraw an individual's unescorted access authorization based on information obtained after the background investigation has been completed and the individual granted unescorted access information.

(5) Licensees shall maintain a list of persons currently approved for unescorted access authorization. When a licensee determines that a person no longer requires unescorted access or meets the access authorization requirement, the licensee shall remove the person from the approved list as soon as possible, but no later than seven working days, and take prompt measures to ensure that the individual is unable to have unescorted access to the material.

f. Licensees shall develop, implement, and maintain written procedures for implementing the access authorization program. The procedures shall include the provisions for the notification of individuals who are denied unescorted access. The procedures shall include provisions for the review, at the request of the affected individual, of a denial or termination of unescorted access authorization. The procedures shall contain a provision to ensure that the individual is informed of the grounds for the denial or termination of unescorted access authorization and allow the individual an opportunity to provide additional relevant information.

g. Right to correct and complete information.

(1) Prior to any final adverse determination, licensees shall provide each individual subject to this subsection with the right to complete, correct, and explain information obtained as a result of the licensee's background investigation. Confirmation of receipt by the individual of this notification shall be maintained by the licensee for a period of one year from the date of the notification.

(2) If, after reviewing his criminal history record, an individual believes that it is incorrect or incomplete in any respect and wishes to change, correct, update, or explain anything in the record, the individual may initiate challenge procedures. These procedures include direct application by the individual challenging the record to the law-enforcement agency that contributed the questioned information or a direct challenge as to the accuracy or completeness of any entry on the criminal history record to the Federal Bureau of Investigation, Criminal Justice Information Services (CJIS) Division, ATTN: SCU, Mod. D-2, 1000 Custer Hollow Road, Clarksburg, WV 26306 as set forth in 28 CFR 16.30 through 28 CFR 16.34. In the latter case, the Federal Bureau of Investigation (FBI) will forward the challenge to the agency that submitted the data and will request that the agency verify or correct the challenged entry. Upon receipt of an official communication directly from the agency that contributed the original information, the FBI Identification Division will make any change necessary in accordance with the information supplied by that agency. Licensees shall provide at least 10 days for an individual to initiate action to challenge the results of an FBI criminal history records check after the record being made available for his review. The licensee may make a final adverse determination based upon the criminal history records only after receipt of the FBI's confirmation or correction of the record.

h. Records.

(1) The licensee shall retain documentation regarding the trustworthiness and reliability of individual employees for three years from the date the individual no longer requires unescorted access to Category 1 or Category 2 quantities of radioactive material.

(2) The licensee shall retain a copy of the current access authorization program procedures as a record for three years after the procedure is no longer needed. If any portion of the procedure is superseded, the licensee shall retain the superseded material for three years after the record is superseded.

(3) The licensee shall retain the list of individuals approved for unescorted access authorization for three years after the list is superseded or replaced.

3. Background investigations.

a. Before allowing an individual unescorted access to Category 1 or Category 2 quantities of radioactive material or to the devices containing the material, licensees shall complete a background investigation of the individual seeking unescorted access authorization. The scope of the investigation shall encompass at least the seven years preceding the date of the background investigation or since the individual's 18th birthday, whichever is shorter. The background investigation shall include at a minimum:

(1) Fingerprinting and an FBI identification and criminal history records check in accordance with subdivision 4 of this subsection;

(2) Verification of true identity of the individual who is applying for unescorted access authorization. A licensee shall review official identification documents (e.g., driver's license; passport; government identification; certificate of birth issued by the state, province, or country of birth) and compare the documents to personal information data provided by the individual to identify any discrepancy in the information. Licensees shall document the type, expiration, and identification number of the identification document or maintain a photocopy of identifying documents on file in accordance with subdivision 6 of this subsection. Licensees shall certify in writing that the identification was properly reviewed and shall maintain the certification and all related documents for review upon inspection;

(3) Verification of employment history, including military history. Licensees shall verify the individual's employment with each previous employer for the most recent seven years before the date of application;

(4) Verification that the individual participated in the education process during the claimed period;

(5) Completion of reference checks to determine the character and reputation of the individual who has applied for unescorted access authorization. Unless other references are not available, reference checks may not be conducted with any person who is known to be a close member of the individual's family, including the individual's spouse, parents, siblings, or children, or any individual who resides in the individual's permanent household. Reference checks under this subsection shall be limited to whether the individual has been and continues to be trustworthy and reliable;

(6) To the extent possible, obtain independent information to corroborate the information provided by the individual (e.g., seek references not supplied by the individual); and

(7) If a previous employer, educational institution, or any other entity with which the individual claims to have been engaged fails to provide the information or indicates an inability or unwillingness to provide information within a timeframe deemed appropriate by the licensee but at least after 10 business days of the request or if the licensee is unable to reach the entity, the licensee shall document the refusal, unwillingness, or inability in the record of investigation and attempt to obtain the information from an alternate source.

b. Individuals who have been determined to be trustworthy and reliable for unescorted access to Category 1 or Category 2 quantities of radioactive material in accordance with fingerprint orders as effective on October 3, 2008, can continue to have unescorted access to Category 1 and Category 2 quantities of radioactive material without further investigation. These individuals shall be subject to the reinvestigation requirement of subdivision 3 c of this subsection.

c. Licensees shall conduct a reinvestigation every 10 years for any individual with unescorted access to Category 1 or Category 2 quantities of radioactive material. The reinvestigation shall consist of fingerprinting and an FBI identification and criminal history records check in accordance with subdivision 4 of this subsection. The reinvestigations shall be completed within 10 years of the date on which these elements were last completed.

4. Requirements for criminal history records checks of individuals granted unescorted access to Category 1 or Category 2 quantities of radioactive material.

a. General performance objective and requirements.

(1) Except for those individuals listed in subdivision 5 a of this subsection and those individuals grandfathered under subdivision 3 b of this subsection, each licensee subject to the provisions of this section shall fingerprint each individual who is to be permitted unescorted access to Category 1 or Category 2 quantities of radioactive material. The licensee shall submit all collected fingerprints to the NRC for transmission to the FBI. The licensee shall use the information received from the FBI as part of the required background investigation to determine whether to grant or deny further unescorted access to Category 1 or Category 2 quantities of radioactive materials for that individual.

(2) The licensee shall notify each affected individual that his fingerprints will be used to secure a review of his criminal history record and shall inform him of the procedures for revising the record or adding explanations to the record.

(3) Fingerprinting is not required if a licensee is reinstating an individual's unescorted access authorization to Category 1 or Category 2 quantities of radioactive material if:

(a) The individual returns to the same facility that granted unescorted access authorization within 365 days of the termination of his unescorted access authorization; and

(b) The previous access was terminated under favorable conditions.

(4) Fingerprints do not need to be taken if an individual who is an employee of a licensee, contractor, manufacturer, or supplier has been granted unescorted access to Category 1 or Category 2 quantities of radioactive material, access to safeguards information, or safeguards information-modified handling by another licensee based upon a background investigation conducted under this subsection, regulations or Fingerprint Orders from another agreement state, or 10 CFR Part 73. An existing criminal history records check file may be transferred to the licensee asked to grant unescorted access in accordance with the provisions of subdivision 6 c of this subsection.

(5) Licensees shall use the information obtained as part of a criminal history records check solely for the purpose of determining an individual's suitability for unescorted access authorization to Category 1 or Category 2 quantities of radioactive materials, access to safeguards information, or safeguards information-modified handling.

b. Prohibitions.

(1) Licensees may not base a final determination to deny an individual unescorted access authorization to Category 1 or Category 2 quantities of radioactive material solely on the basis of information received from the FBI involving:

(a) An arrest more than one year old for which there is no information of the disposition of the case; or

(b) An arrest that resulted in dismissal of the charge or an acquittal.

(2) Licensees may not use information received from a criminal history records check obtained under this subsection in a manner that would infringe upon the rights of any individual under the First Amendment to the Constitution of the United States, nor shall licensees use the information in any way that would discriminate among individuals on the basis of race, religion, national origin, gender, or age.

c. Procedures for processing of fingerprint checks.

(1) For the purpose of complying with this subsection, licensees shall use an appropriate method listed in 10 CFR 37.7 to submit to the U.S. Nuclear Regulatory Commission, Director, Division of Physical and Cyber Security Policy, 11545 Rockville Pike, ATTN: Criminal History Program/Mail Stop T-07D04M, Rockville, MD, 20852, one completed, legible standard fingerprint card (form FD-258, ORIMDNRCOOOZ), electronic fingerprint scan, or, where practicable, other fingerprint record for each individual requiring unescorted access to Category 1 or Category 2 quantities of radioactive material. Copies of these forms may be obtained by emailing MAILSVS.Resource@nrc.gov. Guidance on submitting electronic fingerprints can be found at https://www.nrc.gov/security/chp.html.

(2) Fees for processing of fingerprint cards are due upon application. Licensees shall submit payment with the application for the processing of fingerprints through corporate check, certified check, cashier's check, money order, or electronic payment, made payable to the "U.S. NRC." (For guidance on making electronic payments, contact the Division of Physical and Cyber Security Policy by emailing crimhist.resource@nrc.gov.) Combined payment for multiple applications is acceptable. The NRC publishes the amount of the fingerprint check application fee on the NRC public website. To find the current fee amount, go to the Licensee Criminal History Records Checks & Firearms Background Check information page at https://www.nrc.gov/security/chp.html and see the link for How do I determine how much to pay for the request?.

(3) The NRC will forward to the submitting licensee all data received from the FBI as a result of the licensee's application for a criminal history records check.

5. Relief.

a. Fingerprinting, identification and criminal history records checks, and other elements of the background investigation required by this subsection are not required for the following individuals prior to granting unescorted access to Category 1 or Category 2 quantities of radioactive material:

(1) An employee of the NRC or of the executive branch of the U.S. government who has undergone fingerprinting for a prior U.S. government criminal history records check;

(2) A member of Congress;

(3) An employee of a member of Congress or congressional committee who has undergone fingerprinting for a prior U.S. government criminal history records check;

(4) The governor of a state or his designated state employee representative;

(5) Federal, state, or local law-enforcement personnel;

(6) State radiation control program directors and state homeland security advisors or their designated employee representatives;

(7) State radiation program employees conducting security inspections on behalf of the NRC under an agreement executed under § 274i of the Atomic Energy Act (42 USC § 2021i);

(8) Representatives of the International Atomic Energy Agency (IAEA) engaged in activities associated with the U.S./IAEA Safeguards Agreement who have been certified by the NRC;

(9) Emergency response personnel who are responding to an emergency;

(10) Commercial vehicle drivers for road shipments of Category 1 and Category 2 quantities of radioactive material;

(11) Package handlers at transportation facilities such as freight terminals and railroad yards;

(12) Any individual who has an active federal security clearance and provides the appropriate documentation. Written confirmation from the agency or employer that granted the federal security clearance or reviewed the criminal history records check shall be provided to the licensee. The licensee shall retain this documentation for a period of three years from the date the individual no longer requires unescorted access to Category 1 or Category 2 quantities of radioactive material; and

(13) Any individual employed by a service provider licensee for whom the service provider licensee has conducted the background investigation for the individual and approved the individual for unescorted access to Category 1 or Category 2 quantities of radioactive material. Written verification from the service provider shall be provided to the licensee. The licensee shall retain the documentation for a period of three years from the date the individual no longer requires unescorted access to Category 1 or Category 2 quantities of radioactive material.

b. Fingerprinting and identification and criminal history records checks required by this subsection are not required for an individual who has had a favorably adjudicated U.S. Government criminal history records check within the last five years, under a comparable U.S. Government program involving fingerprinting and an FBI identification and criminal history records check, and the individual provides the appropriate documentation. Written confirmation from the agency or employer that reviewed the criminal history records check shall be provided to the licensee. The licensee shall retain this documentation for a period of three years from the date the individual no longer requires unescorted access to Category 1 or Category 2 quantities of radioactive material. These programs include:

(1) National Agency Check;

(2) Transportation Worker Identification Credentials (TWIC) under 49 CFR Part 1572;

(3) Bureau of Alcohol, Tobacco, Firearms, and Explosives background check and clearances under 27 CFR Part 555;

(4) Health and Human Services security risk assessments for possession and use of select agents and toxins under 42 CFR Part 73;

(5) Hazardous material security threat assessment for hazardous material endorsement to commercial driver's license under 49 CFR Part 1572; and

(6) Customs and Border Protection's Free and Secure Trade (FAST) Program.

6. Protection of information.

a. Each licensee that obtains background information on an individual under this subsection shall establish and maintain a system of files and written procedures for protection of the record and the personal information from unauthorized disclosure.

b. The licensee may not disclose the record or personal information collected and maintained to persons other than the subject individual, his representative, or to those who have a need to have access to the information in performing assigned duties in the process of granting or denying unescorted access to Category 1 or Category 2 quantities of radioactive material. No individual authorized to have access to the information may disseminate the information to any other individual who does not have a need to know.

c. The personal information obtained on an individual from a background investigation may be provided to another licensee:

(1) Upon the individual's written request to the licensee holding the data to disseminate the information contained in that individual's file; and

(2) The recipient licensee verifies information such as name, date of birth, social security number, gender, and other applicable physical characteristics.

d. The licensee shall make background investigation records obtained under this subsection available for examination by an authorized representative of the agency to determine compliance with the regulations and laws.

e. The licensee shall retain all fingerprint and criminal history records (including data indicating no record) received from the FBI, or a copy of these records if the individual's file has been transferred, on an individual for three years from the date the individual no longer requires unescorted access to Category 1 or Category 2 quantities of radioactive material.

7. Access authorization program review.

a. Each licensee shall be responsible for the continuing effectiveness of the access authorization program. Each licensee shall ensure that access authorization programs are reviewed to confirm compliance with the requirements of this subsection and that comprehensive actions are taken to correct any noncompliance that is identified. The review program shall evaluate all program performance objectives and requirements. The review shall be performed at least annually.

b. The results of the reviews, along with all recommendations, shall be documented. Each review report shall identify conditions that are adverse to the proper performance of the access authorization program; the cause of the conditions and, when appropriate, recommend corrective actions; and corrective actions taken. The licensee shall review the findings and take additional corrective actions necessary to preclude repetition of the condition, including reassessment of the deficient areas where indicated.

c. Review records shall be maintained for three years.

C. Physical protection requirements during use.

1. Security program.

a. Each licensee that possesses an aggregated Category 1 or Category 2 quantity of radioactive material shall establish, implement, and maintain a security program in accordance with the requirements of this subsection. An applicant for a new license and each licensee that would become newly subject to the requirements of this subsection upon an amendment request for modification of its license shall implement the requirements of this subsection, as appropriate, before taking possession of an aggregated Category 1 or Category 2 quantity of radioactive material. Any licensee that has not previously implemented the requirements of this subsection shall provide written notification to the agency at least 90 days before aggregating radioactive material to a quantity that equals or exceeds the Category 2 threshold.

b. Each licensee shall establish, implement, and maintain a security program that is designed to monitor and, without delay, detect, assess, and respond to an actual or attempted unauthorized access to Category 1 or Category 2 quantities of radioactive material.

c. Each licensee's security program shall include the program features, as appropriate, described in subdivisions 2 through 8 of this subsection.

2. General security program requirements.

a. Security plan.

(1) Each licensee identified in subdivision 1 a of this subsection shall develop a written security plan specific to its facilities and operations. The purpose of the security plan is to establish the licensee's overall security strategy to ensure the integrated and effective functioning of the security program required by this subsection. The security plan shall, at a minimum, (i) describe the measures and strategies used to implement the requirements of this subsection and (ii) identify the security resources, equipment, and technology used to satisfy the requirements of this subsection.

(2) The security plan shall be reviewed and approved by the individual with overall responsibility for the security program.

(3) A licensee shall revise its security plan as necessary to ensure the effective implementation of agency requirements. The licensee shall ensure that (i) the revision has been reviewed and approved by the individual with overall responsibility for the security program and (ii) the affected individuals are instructed on the revised plan before the changes are implemented.

(4) The licensee shall retain a copy of the current security plan as a record for three years after the security plan is no longer required. If any portion of the plan is superseded, the licensee shall retain the superseded material for three years after the record is superseded.

b. Implementing procedures.

(1) The licensee shall develop and maintain written procedures that document how the requirements of this subsection and the security plan will be met.

(2) The implementing procedures and revisions to these procedures shall be approved in writing by the individual with overall responsibility for the security program.

(3) The licensee shall retain a copy of the current procedure as a record for three years after the procedure is no longer needed. Superseded portions of the procedure shall be retained for three years after the record is superseded.

c. Training.

(1) Each licensee shall conduct training to ensure that those individuals implementing the security program possess and maintain the knowledge, skills, and abilities to carry out their assigned duties and responsibilities effectively. The training shall include at a minimum, instruction on:

(a) The licensee's security program and procedures to secure Category 1 or Category 2 quantities of radioactive material, and the purpose and function of the security measures employed;

(b) The responsibility to report promptly to the licensee any condition that causes or may cause a violation of agency requirements;

(c) The responsibility of the licensee to report promptly to the local law-enforcement agency and the agency any actual or attempted theft, sabotage, or diversion of Category 1 or Category 2 quantities of radioactive material; and

(d) The appropriate response to security alarms.

(2) In determining those individuals who shall be trained on the security program, the licensee shall consider each individual's assigned activities during authorized use and response to potential situations involving actual or attempted theft, diversion, or sabotage of Category 1 or Category 2 quantities of radioactive material. The extent of the training shall be commensurate with the individual's potential involvement in the security of Category 1 or Category 2 quantities of radioactive material.

(3) Refresher training shall be provided at a frequency not to exceed 12 months and when significant changes have been made to the security program. This training shall include (i) review of the training requirements of this subsection and changes made to the security program since the last training; (ii) reports on all relevant security issues, problems, and lessons learned; (iii) relevant results of agency inspections; and (iv) relevant results of the licensee's program review and testing and maintenance.

(4) The licensee shall maintain records of the initial and refresher training for three years from the date of the training. The training records shall include dates of the training, topics covered, a list of licensee personnel in attendance, and related information.

d. Protection of information.

(1) Licensees authorized to possess Category 1 or Category 2 quantities of radioactive material shall limit access to and prevent the unauthorized disclosure of their security plan, implementing procedures, and the list of individuals who have been approved for unescorted access.

(2) Efforts to limit access shall include the development, implementation, and maintenance of written policies and procedures for controlling access to and for proper handling and protection against unauthorized disclosure of the security plan, implementing procedures, and the list of individuals who have been approved for unescorted access.

(3) Before granting an individual access to the security plan, implementing procedures, or the list of individuals who have been approved for unescorted access, licensees shall:

(a) Evaluate an individual's need to know the security plan, implementing procedures, or the list of individuals who have been approved for unescorted access; and

(b) If the individual has not been authorized for unescorted access to Category 1 or Category 2 quantities of radioactive material, the licensee shall complete a background investigation to determine the individual's trustworthiness and reliability. A trustworthiness and reliability determination shall be conducted by the reviewing official and shall include the background investigation elements contained in subdivisions B 3 a (2) through (7) of this section.

(4) Licensees need not subject any individual to background investigation elements for protection of information if that individual is included in the categories of individuals listed in subdivisions B 5 a (1) through (12) of this section or is a security service provider employee, provided written verification that the employee has been determined to be trustworthy and reliable, by the required background investigation in subdivisions B 3 a (2) though (7) of this subsection, has been provided by the security service provider.

(5) The licensee shall document the basis for concluding that an individual is trustworthy and reliable and should be granted access to the security plan, implementing procedures, or the list of individuals who have been approved for unescorted access.

(6) Licensees shall maintain a list of persons currently approved for access to the security plan implementing procedures, or the list of individuals who have been approved for unescorted access. When a licensee determines that a person no longer needs access to the security plan, implementing procedures, or the list of individuals who have been approved for unescorted access or no longer meets the access authorization requirements for access to the information, the licensee shall remove the person from the approved list as soon as possible, but no later than seven working days after the determination, and take prompt measures to ensure that the individual is unable to obtain the security plan, implementing procedures, or the list of individuals who have been approved for unescorted access.

(7) When not in use, the licensee shall store its security plan, implementing procedures, and the list of individuals who have been approved for unescorted access in a manner to prevent unauthorized access. Information stored in nonremovable electronic form shall be password protected.

(8) The licensee shall retain as a record a copy of the information protection procedures and the list of individuals approved for access to the security plan, implementing procedures, or the list of individuals who have been approved for unescorted access for three years after the document has been superseded.

3. Local law-enforcement agency (LLEA) coordination.

a. A licensee subject to this subsection shall coordinate, to the extent practicable, with an LLEA for responding to threats to the licensee's facility, including any necessary armed response. The information provided to the LLEA shall include:

(1) A description of the facilities and the Category 1 and Category 2 quantities of radioactive materials along with a description of the licensee's security measures that have been implemented to comply with this subsection; and

(2) A notification that the licensee will request a timely armed response by the LLEA to any actual or attempted theft, sabotage, or diversion of Category 1 or Category 2 quantities of material.

b. The licensee shall notify the agency within three business days if:

(1) The LLEA has not responded to the request for coordination within 60 days of the coordination request; or

(2) The LLEA notifies the licensee that the LLEA does not plan to participate in coordination activities.

c. The license shall document its efforts to coordinate with the LLEA. The documentation shall be kept for three years.

d. The licensee shall coordinate with the LLEA at least every 12 months, or when changes to the facility design or operation adversely affect the potential vulnerability of the licensee's material to theft, sabotage, or diversion.

4. Security zones.

a. Licensees shall ensure that all aggregated Category 1 or Category 2 quantities of radioactive material are used or stored within licensee-established security zones. Security zones may be permanent or temporary.

b. Temporary security zones shall be established as necessary to meet the licensee's transitory or intermittent business activities, such as periods of maintenance, source delivery, and source replacement.

c. Security zones shall, at a minimum, allow unescorted access only to approved individuals by:

(1) Isolation of Category 1 and Category 2 quantities of radioactive materials by the use of continuous physical barriers that allow access to the security zone only through established access control points. A physical barrier is a natural or man-made structure or formation sufficient for the isolation of the Category 1 or Category 2 quantities of radioactive material within a security zone;

(2) Direct control of the security zone by approved individuals at all times; or

(3) A combination of continuous physical barriers and direct control.

d. For Category 1 quantities of radioactive material during periods of maintenance, source receipt, preparation for shipment, installation, or source removal or exchange, the licensee shall, at a minimum, provide sufficient individuals approved for unescorted access to maintain continuous surveillance of sources in temporary security zones and in any security zone in which physical barriers or intrusion detection systems have been disabled to allow such activities.

e. Individuals not approved for unescorted access to Category 1 or Category 2 quantities of radioactive material shall be escorted by an approved individual when in a security zone.

5. Monitoring, detection, and assessment.

a. Monitoring and detection.

(1) Licensees shall establish and maintain the capability to continuously monitor and detect without delay all unauthorized entries into its security zones. Licensees shall provide the means to maintain continuous monitoring and detection capability in the event of a loss of the primary power source, or provide for an alarm and response in the event of a loss of this capability to continuously monitor and detect unauthorized entries.

(2) Monitoring and detection shall be performed by:

(a) A monitored intrusion detection system that is linked to an onsite or offsite central monitoring facility;

(b) Electronic devices for intrusion detection alarms that will alert nearby facility personnel;

(c) A monitored video surveillance system;

(d) Direct visual surveillance by approved individuals located within the security zone; or

(e) Direct visual surveillance by a licensee designed individual located outside the security zone.

(3) A licensee subject to this subsection shall also have a means to detect unauthorized removal of the radioactive material from the security zone. This detection capability shall provide:

(a) For Category 1 quantities of radioactive material, immediate detection of any attempted unauthorized removal of the radioactive material from the security zone. Such immediate detection capability shall be provided by electronic sensors linked to an alarm, continuous monitored video surveillance, or direct visual surveillance; and

(b) For Category 2 quantities of radioactive material, weekly verification through physical checks, tamper indicating devices, use, or other means to ensure that the radioactive material is present.

b. Licensees shall immediately assess each actual or attempted unauthorized entry into the security zone to determine whether the unauthorized access was an actual or attempted theft, sabotage, or diversion.

c. For personnel and automated or electronic systems supporting the licensee's monitoring, detection, and assessments system, licensees shall:

(1) Maintain continuous capability for personnel communication and electronic data transmission and processing among site security systems; and

(2) Provide an alternate communication capability for personnel, and an alternative data transmission and processing capability, in the event of a loss of the primary means of communication or data transmission and processing. Alternative communications and data transmissions systems may not be subject to the same failure modes as the primary systems.

d. Licensees shall immediately respond to any actual or attempted unauthorized access to the security zones, or actual or attempted theft, sabotage, or diversion of Category 1 or Category 2 quantities of radioactive material at licensee facilities or temporary job sites. For any unauthorized access involving an actual or attempted theft, sabotage, or diversion of Category 1 or Category 2 quantities of radioactive material, the licensee's response shall include requesting, without delay, an armed response from the LLEA.

6. Maintenance and testing.

a. Each licensee subject to this subsection shall implement a maintenance and testing program to ensure that intrusion alarms, associated communication systems, and other physical components of the systems used to secure or detect unauthorized access to radioactive material are maintained in operable condition and are capable of performing their intended function when needed. The equipment relied on to meet the security requirements of this subsection shall be inspected and tested for operability and performance at the manufacturer's suggested frequency. If there is no frequency suggested by the manufacturer or the frequency specified is greater than three months, the testing shall be performed at least quarterly, not to exceed three months.

b. The licensee shall maintain records on the maintenance and testing activities for three years.

7. Requirements for mobile devices. Each licensee that possesses mobile devices containing Category 1 or Category 2 quantities of radioactive material shall:

a. Have two independent physical controls that form tangible barriers to secure the material from unauthorized removal when the device is not under direct control and constant surveillance by the licensee; and

b. For devices in or on a vehicle or trailer, unless the health and safety requirements for a site prohibit the disabling of the vehicle, the licensee shall utilize a method to disable the vehicle or trailer when not under direct control and constant surveillance by the licensee. Licensees shall not rely on the removal of an ignition key to meet this requirement.

8. Security program review.

a. Each licensee shall be responsible for the continuing effectiveness of the security program. Each licensee shall ensure that the security program is reviewed to confirm compliance with the requirements of this subsection and that comprehensive actions are taken to correct any noncompliance that is identified. The review shall include the radioactive material security program content and implementation. The review shall be conducted at least annually, not to exceed 12 months.

b. The results of the review, along with all recommendations, shall be documented. Each review report shall identify conditions that are adverse to the proper performance of the security program, the cause of the condition, corrective actions taken, and, when appropriate, recommend corrective actions. The licensee shall review the findings and take any additional corrective actions necessary to preclude repetition of the condition, including reassessment of the deficient areas where indicated.

c. The licensee shall maintain the review documentation for three years.

9. Reporting of events.

a. The licensee shall immediately notify the LLEA after determining that an unauthorized entry resulted in an actual or attempted theft, sabotage, or diversion of Category 1 or Category 2 quantity of radioactive material. As soon as possible after initiating a response, but not at the expense of causing delay or interfering with the LLEA response to the event, the licensee shall notify the agency by telephone at 804-864-8150 during normal business hours and 804-674-2400 after hours. In no case shall the notification to the agency be later than four hours after the discovery of any attempted or actual theft, sabotage, or diversion.

b. The licensee shall assess any suspicious activity related to possible theft, sabotage, or diversion of Category 1 or Category 2 quantities of radioactive material and notify the LLEA as appropriate. As soon as possible but not later than four hours after notifying the LLEA, the licensee shall notify the agency by telephone 804-864-8150 during normal business hours and 804-674-2400 after hours.

c. The initial telephonic notification shall be followed within a period of 30 days by a written report submitted to the agency. The report shall include sufficient information for agency analysis and evaluation, including identification of any necessary corrective actions to prevent future instances.

D. Physical protection in transit.

1. Additional requirements for transfer of Category 1 and Category 2 quantities of radioactive material. A licensee transferring a Category 1 or Category 2 quantity of radioactive material to a licensee of the agency, the NRC, or another agreement state shall meet the license verification provisions listed in this subdivision instead of those listed in 12VAC5-481-570.

a. Any licensee transferring Category 1 quantities of radioactive material to a licensee of the agency, the NRC, or another agreement state, prior to conducting such transfer, shall verify with the NRC's license verification system or the license issuing authority that the transferee's license authorizes the receipt of the type, form, and quantity of radioactive material to be transferred and that the licensee is authorized to receive radioactive material at the location requested for delivery. If the verification is conducted by contacting the license-issuing authority, the transferor shall document the verification. For transfers within the same organization, the licensee does not need to verify the transfer.

b. Any licensee transferring Category 2 quantities of radioactive material to a licensee of the agency, the NRC, or another agreement state, prior to conducting such transfer, shall verify with the NRC's license verification system or the license-issuing authority that the transferee's license authorizes the receipt of the type, form, and quantity of radioactive material to be transferred. If the verification is conducted by contacting the license-issuing authority, the transferor shall document the verification. For transfers within the same organization, the licensee does not need to verify the transfer.

c. In an emergency where the licensee cannot reach the license-issuing authority and the license verification system is nonfunctional, the licensee may accept a written certification by the transferee that it is authorized by license to receive the type, form, and quantity of radioactive material to be transferred. The certification shall include the license number, current revision number, issuing agency, expiration date, and for a Category 1 shipment, the authorized address. The licensee shall keep a copy of the certification. The certification shall be confirmed by use of the NRC's license verification system or by contacting the license-issuing authority by the end of the next business day.

d. The transferor shall keep a copy of the verification documentation as a record for three years.

2. Applicability of physical protection of Category 1 and Category 2 quantities of radioactive material during transit.

a. For shipments of category 1 quantities of radioactive material, each shipping licensee shall comply with the requirements for physical protection contained in subdivisions 3 a, 3 e, 4, 5 a (1), 5 b (1), 5 c, 6 a, 6 c, 6 e, 6 g, and 6 h of this subsection.

b. For shipments of Category 2 quantities of radioactive material, each shipping licensee shall comply with the requirements for physical protection contained in subdivisions 3 b through 3 e, 5 a (2), 5 a (3), 5 b (2), 5 c, 6 b, 6 d, 6 f, 6 g, and 6 h of this subsection.

c. The shipping licensee shall be responsible for meeting the requirements of this subsection unless the receiving licensee has agreed in writing to arrange for the in-transit physical protection required under this subsection.

3. Preplanning and coordination of shipment of Category 1 or Category 2 quantities of radioactive material.

a. Each licensee that plans to transport, or deliver to a carrier for transport, licensed material that is a Category 1 quantity of radioactive material outside the confines of the licensee's facility or other place of use or storage shall:

(1) Preplan and coordinate shipment arrival and departure times with the receiving licensee;

(2) Preplan and coordinate shipment information with the governor or the governor's designee of any state through which the shipment will pass to discuss the state's intention to provide law-enforcement escorts and identify safe havens; and

(3) Document the preplanning and coordination activities.

b. Each licensee that plans to transport, or deliver to a carrier for transport, licensed material that is a Category 2 quantity of radioactive material outside the confines of the licensee's facility or other place of use or storage shall coordinate the shipment no-later-than arrival time and the expected shipment arrival with the receiving licensee. The licensee shall document the coordination activities.

c. Each licensee that receives a shipment of a Category 2 quantity of radioactive material shall confirm receipt of the shipment with the originator. If the shipment has not arrived by the no-later-than arrival time, the receiving licensee shall notify the originator.

d. Each licensee that transports or plans to transport a shipment of a Category 2 quantity of radioactive material and determines that the shipment will arrive after the no-later-than arrival time provided pursuant to subdivision 3 b of this subsection, shall promptly notify the receiving licensee of the new no-later-than arrival time.

e. The licensee shall retain a copy of the documentation for preplanning and coordination and any revision thereof as a record for three years.

4. As specified in subdivision 3 of this subsection, each licensee shall provide advance notification to the agency and the governor of a state, or the governor's designee, of the shipment of licensed material in a Category 1 quantity, through or across the boundary of the state, before the transport or delivery to a carrier for transport of the licensed material outside the confines of the licensee's facility or other place of use or storage.

a. Procedures for submitting advance notification:

(1) The notification shall be made to the agency and to the office of each appropriate governor or governor's designee. The contact information, including telephone and mailing addresses, of governors and governor's designees is available on the NRC website at https://scp.nrc.gov/special/designee.pdf. The notification to the agency shall be in accordance with 12VAC5-481-150.

(2) A notification delivered by mail shall be postmarked at least seven days before transport of the shipment commences at the shipping facility.

(3) A notification delivered by any means other than mail shall reach the agency at least four days before the transport of the shipment commences and shall reach the office of the governor or the governor's designee at least four days before transport of a shipment within or through the state.

b. Each advance notification of shipment of Category 1 quantities of radioactive material shall contain the following information, if available at the time of the notification:

(1) The name, address, and telephone number of the shipper, carrier, and receiver of the Category 1 radioactive material;

(2) The license numbers of the shipper and receiver;

(3) A description of the radioactive material contained in the shipment, including the radionuclides and quantity;

(4) The point of origin of the shipment and the estimated time and date that shipment will commence;

(5) The estimated time and date that the shipment is expected to enter each state along the route;

(6) The estimated time and date of arrival for the shipment at the destination; and

(7) A point of contact, with a telephone number, for current shipment information.

c. Revision notice.

(1) The licensee shall provide any information not previously available at the time of the initial notification, as soon as the information becomes available but not later than commencement of the shipment, to the agency and the governor of the state or the governor's designee.

(2) A licensee shall promptly notify the agency and governor of the state or the governor's designee of any changes to the information provided in accordance with this subdivision 4.

d. Each licensee who cancels a shipment for which advance notification has been sent shall send a cancellation notice to the agency and the governor of each state or to the governor's designee previously notified. The licensee shall send the cancellation notice before the shipment would have commenced or as soon thereafter as possible. The licensee shall state in the notice that it is a cancellation and identify the advance notification that is being canceled.

e. The licensee shall retain a copy of the advance notification and any revision and cancellation notices as a record for three years.

f. State officials, state employees, and other individuals, whether or not licensees of the agency, NRC, or another agreement state, who receive schedule information of the kind specified in subdivision 4 b of this subsection shall protect that information against unauthorized disclosure as specified in subdivision C 2 d of this section.

5. Requirements for physical protection of Category 1 and Category 2 quantities of radioactive material during shipment.

a. Shipments by road.

(1) Each licensee who transports or delivers to a carrier for transport in a single shipment a Category 1 quantity of radioactive material shall:

(a) Ensure that movement control centers are established that maintain position information from a remote location. These control centers shall monitor shipments 24 hours a day, seven days a week and have the ability to communicate immediately, in an emergency, with the appropriate law-enforcement agencies;

(b) Ensure that redundant communications are established that allow the transport to contact the escort vehicle, when an escort vehicle is used, and movement control center at all times. Redundant communications may not be subject to the same interference factors as the primary communication;

(c) Ensure that shipments are continuously and actively monitored by a telemetric position monitoring system or an alternative tracking system reporting to a movement control center. A movement control center shall provide positive confirmation of the location, status, and control over the shipment. The movement control center shall be prepared to promptly implement preplanned procedures in response to deviations from the authorized route or a notification of actual, attempted, or suspicious activities related to the theft, loss, or diversion of a shipment. These procedures will include the identification of and contact information for the appropriate LLEA along the shipment route;

(d) Provide an individual to accompany the driver for those highway shipments with a driving time period greater than the maximum number of allowable hours of service in a 24-hour duty day as established by the U.S. Department of Transportation Federal Motor Carrier Safety Administration. The accompanying individual may be another driver; and

(e) Develop written normal and contingency procedures to address (i) notifications to the communication center and law-enforcement agencies; (ii) communication protocols that shall include a strategy for the use of authentication codes and duress codes and provisions for refueling and other stops, detours, and locations where communication is expected to be temporarily lost; (iii) loss of communication; and (iv) responses to an actual or attempted theft or diversion of a shipment.

(f) Each licensee who makes arrangements for the shipment of Category 1 quantities of radioactive material shall ensure that drivers, accompanying personnel, and movement control center personnel have access to the normal and contingency procedures.

(2) Each licensee that transports Category 2 quantities of radioactive material shall maintain constant control and surveillance during transit and have the capability for immediate communication to summon appropriate response or assistance.

(3) Each licensee who delivers to a carrier for transport in a single shipment a Category 2 quantity of radioactive material shall:

(a) Use carriers that have established package tracking systems. An established package tracking system is a documented, proven, and reliable system routinely used to transport objects of value. In order for a package tracking system to maintain constant control and surveillance, the package tracking system shall allow the shipper or transporter to identify when and where the package was last and when it should arrive at the next point of control;

(b) Use carriers that maintain constant control and surveillance during transit and have the capability for immediate communication to summon appropriate response or assistance; and

(c) Use carriers that have established tracking systems that require an authorized signature prior to releasing the package for delivery or return.

b. Shipments by rail.

(1) Each licensee who transports, or delivers to a carrier for transport, in a single shipment a Category 1 quantity of radioactive material shall:

(a) Ensure that rail shipments are monitored by a telemetric position monitoring system or an alternative tracking system reporting to the licensee, third-party, or railroad communications center. The communications center shall provide positive confirmation of the location of the shipment and its status. The communications center shall implement preplanned procedures in response to deviations from the authorized route or to a notification of actual, attempted, or suspicious activities related to the theft or diversion of a shipment. These procedures will include the identification of and contact information for the appropriate LLEA along the shipment route; and

(b) Ensure that periodic reports to the communications center are made at preset intervals.

(2) Each licensee who transports, or delivers to a carrier for transport, in a single shipment a Category 2 quantity of radioactive material shall:

(a) Use carriers that have established package tracking systems. An established package tracking system is a documented, proven, and reliable system routinely used to transport objects of value. In order for a package tracking system to maintain constant control and surveillance, the package tracking system shall allow the shipper or transporter to identify when and where the package was last and when it should arrive at the next point of control;

(b) Use carriers that maintain constant control and surveillance during transit and have the capability for immediate communication to summon appropriate response or assistance; and

(c) Use carriers that have established tracking systems that require an authorized signature prior to releasing the package for delivery or return.

c. Each licensee who makes arrangements for the shipment of Category 1 quantities of radioactive material shall immediately conduct an investigation upon discovery that a Category 1 shipment is lost or missing. Each licensee who makes arrangements for the shipment of Category 2 quantities of radioactive material shall immediately conduct an investigation, in coordination with the receiving licensee, of any shipment that has not arrived by the designated no-later-than arrival time.

6. Reporting of events.

a. The shipping licensee shall notify the appropriate LLEA and the agency within one hour of its determination that a shipment of Category 1 quantities of radioactive material is lost or missing. The appropriate LLEA would be the law-enforcement agency in the area of the shipment's last confirmed location. During the investigation required by this subsection, the shipping licensee will provide agreed upon updates to the agency on the status of the investigation.

b. The shipping licensee shall notify the agency within four hours of its determination that a shipment of Category 2 quantities of radioactive material is lost or missing. If, after 24 hours of its determination that the shipment is lost or missing, the radioactive material has not been located and secure, the licensee shall immediately notify the agency.

c. The shipping licensee shall notify the designated LLEA along the shipment route as soon as possible upon discovery of any actual or attempted theft of diversion of a shipment or suspicious activities related to the theft or diversion of a shipment of a Category 1 quantity of radioactive material. As soon as possible after notifying the LLEA, the licensee shall notify the agency upon discovery of any actual or attempted theft or diversion of a shipment, or any suspicious activity related to the shipment, of Category 1 radioactive material.

d. The shipping licensee shall notify the agency as soon as possible upon discovery of any actual or attempted theft or diversion of a shipment, or any suspicious activity related to the shipment, of a Category 2 quantity of radioactive material.

e. The shipping licensee shall notify the agency and the LLEA as soon as possible upon recovery of any lost or missing Category 1 quantities of radioactive material.

f. The shipping licensee shall notify the agency as soon as possible upon recovery of any lost or missing Category 2 quantities of radioactive material.

g. The initial telephonic notification required by subdivisions 6 a through 6 d of this subsection shall be followed within a period of 30 days by a written report submitted to the agency. A written report is not required for notifications on suspicious activities required by subdivisions 6 c and 6 d of this subsection. The report shall include the following information:

(1) A description of the licensed material involved, including kind, quantity, and chemical and physical form;

(2) A description of the circumstances under which the loss or theft occurred;

(3) A statement of disposition, or probable disposition, of the licensed material involved;

(4) Actions that have been taken, or will be taken, to recover the material; and

(5) Procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of licensed material.

h. Subsequent to filing the written report, the licensee shall also report any additional substantive information on the loss or theft within 30 days after the licensee learns of such information.

E. Records.

1. Each record required by this section shall be legible throughout the retention period specified. The record may be the original or a reproduced copy or a microform, provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, and specifications shall include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.

2. Licensees shall maintain the records that are required by this section for the period specified. If a retention period is not otherwise specified, these records shall be retained until the agency terminates the facility's license. All records related to this section may be destroyed upon agency termination of the facility license.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 25, eff. October 3, 2008; amended, Virginia Register Volume 25, Issue 21, eff. August 6, 2009; Volume 32, Issue 12, eff. March 9, 2016; Volume 32, Issue 24, eff. August 25, 2016; Volume 34, Issue 2, eff. October 18, 2017; Volume 37, Issue 25, eff. January 14, 2022; Volume 39, Issue 24, eff. August 16, 2023.

12VAC5-481-460 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; repealed, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-470 Special requirements for specific licenses of broad scope

This section prescribes requirements for the issuance of specific licenses of broad scope for radioactive material and certain regulations governing holders of such licenses. (Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the Nuclear Regulatory Commission, Washington, D.C. 20555-0001.)

A. The different types of broad scope licenses are set forth below:

1. A "Type A specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of the radioactive material specified in the license, but not exceeding quantities specified in the license, for any authorized purpose. The quantities specified are usually in the multicurie range.

2. A "Type B specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of radioactive material specified in 12VAC5-481-3760, for any authorized purpose. The possession limit for a Type B license of broad scope, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in 12VAC5-481-3760, Column I. If two or more radionuclides are possessed thereunder, the possession limit for each is determined as follows: for each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in 12VAC5-481-3760, Column I, for that radionuclide. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.

3. A "Type C specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of radioactive material specified in 12VAC5-481-3760, for any authorized purpose. The possession limit for a Type C license of broad scope, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in 12VAC5-481-3760, Column II. If two or more radionuclides are possessed thereunder, the possession limit is determined for each as follows: for each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in 12VAC5-481-3760, Column II, for that radionuclide. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.

B. An application for a Type A specific license of broad scope will be approved if:

1. The applicant satisfies the general requirements specified in 12VAC5-481-450;

2. The applicant has engaged in a reasonable number of activities involving the use of radioactive material; and

3. The applicant has established administrative controls and provisions relating to organization and management, procedures, recordkeeping, material control and accounting, and management review that are necessary to assure safe operations, including:

a. The establishment of a radiation safety committee composed of such persons as a radiation safety officer, a representative of management, and persons trained and experienced in the safe use of radioactive material;

b. The appointment of a radiation safety officer who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiation safety matters; and

c. The establishment of appropriate administrative procedures to assure:

(1) Control of procurement and use of radioactive material;

(2) Completion of safety evaluations of proposed uses of radioactive material that take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and

(3) Review, approval, and recording by the radiation safety committee of safety evaluations of proposed uses prepared in accordance with subdivision 3 c (2) of this subsection prior to use of the radioactive material.

C. An application for a Type B specific license of broad scope will be approved if:

1. The applicant satisfies the general requirements specified in 12VAC5-481-450; and

2. The applicant has established administrative controls and provisions relating to organization and management, procedures, recordkeeping, material control and accounting, and management review that are necessary to assure safe operations, including:

a. The appointment of a radiation safety officer who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiation safety matters, and

b. The establishment of appropriate administrative procedures to assure,

(1) Control of procurement and use of radioactive material,

(2) Completion of safety evaluations of proposed uses of radioactive material that take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures, and

(3) Review, approval, and recording by the radiation safety officer of safety evaluations of proposed uses prepared in accordance with subdivision 2 b (2) of this subsection prior to use of the radioactive material.

D. An application for a Type C specific license of broad scope will be approved if:

1. The applicant satisfies the general requirements specified in 12VAC5-481-450;

2. The applicant submits a statement that radioactive material will be used only by, or under the direct supervision of, individuals who have received:

a. A college degree at the bachelor level, or equivalent training and experience, in the physical or biological sciences or in engineering, and

b. At least 40 hours of training and experience in the safe handling of radioactive material, and in the characteristics of ionizing radiation, units of radiation dose and quantities, radiation detection instrumentation, and biological hazards of exposure to radiation appropriate to the type and forms of radioactive material to be used; and

3. The applicant has established administrative controls and provisions relating to procurement of radioactive material, procedures, recordkeeping, material control and accounting, and management review necessary to assure safe operations.

E. Specific licenses of broad scope are subject to the following conditions:

1. Unless specifically authorized, persons licensed pursuant to 12VAC5-481-470 shall not:

a. Conduct tracer studies in the environment involving direct release of radioactive material;

b. Receive, acquire, own, possess, use, or transfer devices containing 3.7 PBq (100,000 Ci) or more of radioactive material in sealed sources used for irradiation of materials;

c. Conduct activities for which a specific license issued by the agency under Part III (12VAC5-481-380 et seq.), Part V (12VAC5-481-1170 et seq.) or Part VII (12VAC5-481-1660 et seq.) of this chapter is required; or

d. Add or cause the addition of radioactive material to any food, beverage, cosmetic, drug, or other product designed for ingestion or inhalation by, or application to, a human being.

2. Each Type A specific license of broad scope issued under this part shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's radiation safety committee.

3. Each Type B specific license of broad scope issued under this part shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's radiation safety officer.

4. Each Type C specific license of broad scope issued under this part shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals who satisfy the requirements of subsection D of this section.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-480 Special requirements for a specific license to manufacture, assemble, repair, or distribute commodities, products, or devices that contain radioactive material

A. Reserved.

B. Licensing the distribution of radioactive material in exempt quantities. (Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing radioactive material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the Nuclear Regulatory Commission, Washington, DC 20555-0001.)

C. Licensing the manufacture or initial transfer of devices to persons generally licensed under 12VAC5-481-430 B.

1. An application for a specific license to manufacture or initially transfer devices containing radioactive material, excluding special nuclear material, to persons generally licensed under 12VAC5-481-430 B or equivalent regulations of the NRC, or another Agreement state will be approved if:

a. The applicant satisfies the general requirements of 12VAC5-481-450;

b. The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions, and potential hazards of the device to provide reasonable assurance that:

(1) The device can be safely operated by persons not having training in radiological protection;

(2) Under ordinary conditions of handling, storage, and use of the device, the radioactive material contained in the device will not be released or inadvertently removed from the device, and it is unlikely that any person will receive in any period of one calendar quarter a dose in excess of 10% of the limits specified in 12VAC5-481-640; and

(3) Under accident conditions such as fire and explosion associated with handling, storage, and use of the device, it is unlikely that any person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in 12VAC5-481-3580, Column IV;

c. Each device bears a durable, legible, clearly visible label or labels approved by the agency, which contain in a clearly identified and separate statement:

(1) Instructions and precautions necessary to assure safe installation, operation, and servicing of the device; documents such as operating and service manuals may be identified in the label and used to provide this information;

(2) The requirement, or lack of requirement, for leak testing, or for testing any "on-off" mechanism and indicator, including the maximum time interval for such testing, and the identification of radioactive material by isotope, quantity of radioactivity, and date of determination of the quantity; and

(3) The information called for in one of the following statements, as appropriate, in the same or substantially similar form:

(a) The receipt, possession, use, and transfer of this device, Model __________, Serial No. __________, are subject to a general license or the equivalent and the regulations of the Nuclear Regulatory Commission or a state with which the Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited.

CAUTION—RADIOACTIVE MATERIAL

____________________Name of manufacturer or initial transferor

(b) The receipt, possession, use, and transfer of this device, Model __________, Serial No. ___________, are subject to a general license or the equivalent, and the regulations of a licensing state. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited. (The model, serial number, and name of the manufacturer or distributor may be omitted from this label provided the information is elsewhere specified in labeling affixed to the device.)

CAUTION—RADIOACTIVE MATERIAL

____________________Name of manufacturer or initial transferor;

d. Each device having a separable source housing that provides the primary shielding for the source also bears, on the source housing, a durable label containing the device model number and serial number, the isotope and quantity, and the words, "Caution Radioactive Material," the radiation symbol described in 12VAC5-481-850, and the name of the manufacturer or initial distributor;

e. Each device meeting the criteria of 12VAC5-481-430 B 4 m bears a permanent (e.g., embossed, etched, stamped, or engraved) label affixed to the source housing if separate, or the device if the source housing is not separable, that includes the words, "Caution Radioactive Material," and, if practicable, the radiation symbol described in 12VAC5-481-850; and

f. The device has been registered in the Sealed Source and Device Registry.

2. In the event the applicant desires that the device be required to be tested at intervals longer than six months, either for proper operation of the "on-off" mechanism and indicator, if any, or for leakage of radioactive material or for both, the applicant shall include in the application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the device or similar devices and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the device or failure of the "on-off" mechanism and indicator. In determining the acceptable interval for the test for leakage of radioactive material, the agency will consider information that includes, but is not limited to:

a. Primary containment or source capsule;

b. Protection of primary containment;

c. Method of sealing containment;

d. Containment construction materials;

e. Form of contained radioactive material;

f. Maximum temperature withstood during prototype tests;

g. Maximum pressure withstood during prototype tests;

h. Maximum quantity of contained radioactive material;

i. Radiotoxicity of contained radioactive material; and

j. Operating experience with identical devices or similarly designed and constructed devices.

3. In the event the applicant desires that the general licensee under 12VAC5-481-430 B, or under equivalent regulations of the NRC, or another Agreement state, be authorized to install the device, collect the sample to be analyzed by a specific licensee for leakage of radioactive material, service the device, test the "on-off" mechanism and indicator, or remove the device from installation, the applicant shall include in the application written instructions to be followed by the general licensee, estimated calendar quarter doses associated with such activity or activities, and basis for such estimates. The submitted information shall demonstrate that performance of such activity or activities by an individual untrained in radiological protection, in addition to other handling, storage, and use of devices under the general license, is unlikely to cause that individual to receive a calendar quarter dose in excess of 10% of the limits specified in 12VAC5-481-640.

4. Each person licensed under this subsection to distribute devices to generally licensed persons shall:

a. Furnish a copy of the general license contained in 12VAC5-481-430 B to each person to whom he directly or through an intermediate person transfers radioactive material in a device for use pursuant to the general license contained in 12VAC5-481-430 B;

b. Furnish a copy of the general license contained in the NRC's, or another Agreement state's, regulation equivalent to 12VAC5-481-430 B, or alternatively, furnish a copy of the general license contained in 12VAC5-481-430 B to each person to whom he directly or through an intermediate person transfers radioactive material in a device for use pursuant to the general license of the NRC, or another Agreement state. If a copy of the general license in 12VAC5-481-430 B is furnished to such a person, it shall be accompanied by a note explaining that the use of the device is regulated by the NRC, or another Agreement state, under requirements substantially the same as those in 12VAC5-481-430 B;

c. Report to the agency all transfers of such devices to persons for use under the general license in 12VAC5-481-430 B. Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the agency and the general licensee, the type and model number of device transferred, and the quantity and type of radioactive material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall include identification of each intermediate person by name, address, contact, and relationship to the intended user. If no transfers have been made to persons generally licensed under 12VAC5-481-430 B during the reporting period, the report shall so indicate. The report shall cover each calendar quarter and shall be filed within 30 days thereafter;

d. Furnish reports to other agencies.

(1) Report to the NRC all transfers of such devices to persons for use under the NRC's general license in 10 CFR 31.5.

(2) Report to the responsible state agency all transfers of devices manufactured and distributed pursuant to this subsection for use under a general license in that state's regulations equivalent to 12VAC5-481-430 B.

(3) Such reports shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the agency and the general licensee, the type and model of the device transferred, and the quantity and type of radioactive material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall include identification of each intermediate person by name, address, contact, and relationship to the intended user. The report shall be submitted within 30 days after the end of each calendar quarter in which such a device is transferred to the generally licensed person.

(4) If no transfers have been made to NRC general licensees during the reporting period, this information shall be reported to the NRC.

(5) If no transfers have been made to general licensees within a particular state during the reporting period, this information shall be reported to the responsible state agency upon request of that agency; and

e. Keep records showing the name, address, and the point of contact for each general licensee to whom he directly or through an intermediate person transfers radioactive material in devices for use pursuant to the general license provided in 12VAC5-481-430 B, or equivalent regulations of the NRC or another Agreement state. The records shall show the date of each transfer, the radionuclide and the quantity of radioactivity in each device transferred, the identity of any intermediate person, and compliance with the report requirements of subdivision 4 of this subsection.

f. If a notification of bankruptcy has been made under 12VAC5-481-500 E or the license is to be terminated, each person licensed under this section shall provide, upon request, to the agency, the NRC and to any appropriate Agreement state, records of final disposition required under subdivision 4 e of this subsection.

g. The licensee shall maintain all information concerning transfers and receipts of devices that supports the reports required by this section. Records required by this section shall be maintained for a period of three years following the date of the recorded event.

D. Special requirements for the manufacture, initial transfer, assembly, or repair of luminous safety devices for use in aircraft. An application for a specific license to manufacture, assemble, or repair luminous safety devices containing tritium or promethium-147 for use in aircraft, for distribution to persons generally licensed under 12VAC5-481-430 D will be approved if:

1. The applicant satisfies the general requirements specified in 12VAC5-481-450.

2. The applicant submits sufficient information regarding each device pertinent to evaluation of the potential radiation exposure, including:

a. Chemical and physical form and maximum quantity of tritium or promethium-147 in each device;

b. Details of construction and design;

c. Details of the method of binding or containing the tritium or promethium-147;

d. Procedures for and results of prototype testing to demonstrate that the tritium or promethium-147 will not be released to the environment under the most severe conditions likely to be encountered in normal use;

e. Quality assurance procedures to be followed that are sufficient to ensure compliance with subdivision 8 of this subsection; and

f. Any additional information, including experimental studies and tests, required by the NRC to facilitate a determination of the safety of the device.

3. Each device will contain no more than 10 curies of tritium or 300 millicuries of promethium-147. The levels of radiation from each device containing promethium-147 will not exceed 0.5 millirad per hour at 10 centimeters from any surface when measured through 50 milligrams per square centimeter of absorber.

4. The agency determines that:

a. The method of incorporation and binding of the tritium or promethium-147 in the device is such that the tritium or promethium-147 will not be released under the most severe conditions likely to be encountered in normal use and handling of the device;

b. The tritium or promethium-147 is incorporated or enclosed so as to preclude direct physical contact with it by any person;

c. The device is so designed that it cannot easily be disassembled; and

d. Prototypes of the device have been subjected to and have satisfactorily passed the tests required by subdivision 5 of this subsection.

5. The applicant shall subject at least five prototypes of the device to tests as follows:

a. The devices are subjected to tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment of tritium or promethium-147, such as temperature, moisture, absolute pressure, water immersion, vibration, shock, and weathering.

b. The devices are inspected for evidence of physical damage and for loss of tritium or promethium-147 after each stage of testing using methods of inspection adequate for determining compliance with the criteria in subdivision 5 c of this subsection.

c. Device designs are rejected for which the following has been detected for any unit:

(1) A leak resulting in a loss of 0.1% or more of the original amount of tritium or promethium-147 from the device;

(2) Surface contamination of tritium or promethium-147 on the device of more than 2,200 disintegrations per minute per 100 square centimeters of surface area; or

(3) Any other evidence of physical damage.

6. The device has been registered in the Sealed Source and Device Registry.

7. Labeling.

a. A person licensed to manufacture, assemble, or initially transfer devices containing tritium or promethium-147 for distribution to persons generally licensed under 12VAC5-481-430 D, except as provided in subdivision 7 b of this subsection, shall affix to each device a label containing the radiation symbol prescribed by 12VAC5-481-850, such other information as may be required by the agency including disposal instructions when appropriate, and the following or a substantially similar statement that contains the information in the following statement:

The receipt, possession, use, and transfer of this device, Model* ___________, Serial No.*_______, containing ____________ (Identity and quantity of radioactive material) are subject to a general license or the equivalent and the regulations of the U.S. Nuclear Regulatory Commission or of a state with which the NRC has entered into an agreement for the exercise of regulatory authority. Do not remove this label.

CAUTION--RADIOACTIVE MATERIAL

---

(Name of manufacturer, assembler, or initial transferor.)*

*The model, serial number, and name of manufacturer, assembler, or initial transferor may be omitted from this label provided they are elsewhere specified in labeling affixed to the device.

b. If the agency determines that it is not feasible to affix a label to the device containing all the information called for in subdivision 7 a of this subsection, it may waive those requirements and require the following:

(1) A label is affixed to the device identifying:

(i) The manufacturer, assembler, or initial transferor; and

(ii) The type of radioactive material; and

(2) A leaflet bearing the following information be enclosed in or accompany the container in which the device is shipped:

(i) The name of the manufacturer, assembler, or initial transferor;

(ii) The type and quantity of radioactive material;

(iii) The model number;

(iv) A statement that the receipt, possession, use, and transfer of the device are subject to a general license or the equivalent and the regulations of the NRC or of an Agreement state; and

(v) Such other information as may be required by the agency, including disposal instructions when appropriate.

8. Quality assurance; prohibition of transfer.

a. Each person licensed under this subsection shall visually inspect each device and shall reject any that has an observable physical defect that could adversely affect containment of the tritium or promethium-147.

b. Each person licensed under this subsection shall:

(1) Maintain quality assurance systems in the manufacture of the luminous safety device in a manner sufficient to provide reasonable assurance that the safety-related components of the distributed devices are capable of performing their intended functions; and

(2) Subject inspection lots to acceptance sampling procedures, by procedures specified in subdivision 8 c of this subsection and in the license issued under this subsection, to provide at least 95% confidence that the lot tolerance percent defective of 5.0% will not be exceeded.

c. The licensee shall subject each inspection lot to the following:

(1) Tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment of tritium or promethium-147, such as absolute pressure and water immersion.

(2) Inspection for evidence of physical damage, containment failure, or for loss of tritium or promethium-147 after each stage of testing using methods of inspection adequate for applying the following criteria for defective:

(i) A leak resulting in a loss of 0.1% or more of the original amount of tritium or promethium-147 from the device;

(ii) Levels of radiation in excess of 0.5 millirad (5 microgray) per hour at 10 centimeters from any surface when measured through 50 milligrams per square centimeter of absorber if the device contains promethium-147; and

(iii) Any other criteria specified in the license issued under this subsection.

d. No person licensed under this subsection shall transfer to persons generally licensed under 12VAC5-481-430 D or under an equivalent general license of the NRC or other Agreement state:

(1) Any luminous safety device tested and found defective under any condition of a license issued under subdivisions 1 through 6 or this subdivision 8 of this subsection, unless the defective luminous safety device has been repaired or reworked, retested, and determined by an independent inspector to meet the applicable acceptance criteria; or

(2) Any luminous safety device contained within any lot that has been sampled and rejected as a result of the procedures in subdivision 8 b (2) of this subsection, unless:

(i) A procedure for defining sub-lot size, independence, and additional testing procedures is contained in the license issued under this subsection; and

(ii) Each individual sub-lot is sampled, tested, and accepted in accordance with subdivisions 8 b (2) and d (2) (i) of this subsection and any other criteria that may be required as a condition of the license issued under this subsection.

9. Transfer reports.

a. Each person licensed under this subsection shall file an annual report with the agency, which shall state the total quantity of tritium or promethium-147 transferred to persons generally licensed under 12VAC5-481-430 D. The report shall identify each general licensee by name, state the kinds and numbers of luminous devices transferred, and specify the quantity of tritium or promethium-147 in each kind of device. Each report shall cover the year ending June 30 and shall be filed within 30 days thereafter. If no transfers have been made to persons generally licensed under 12VAC5-481-430 D during the reporting period, the report shall indicate so.

b. Each person licensed under this subsection shall report annually all transfers of devices to persons for use under a general license in the NRC or another Agreement state's regulations that are equivalent to 12VAC5-481-430 D to (i) the NRC at Director, Office of Nuclear Material Safety and Safeguards, ATTN: Document Control Desk/GLTS, by an appropriate method listed in 10 CFR 30.6(a) and (ii) the responsible Agreement state agency. The report shall state the total quantity of tritium or promethium-147 transferred, identify each general licensee by name, state the kinds and numbers of luminous devices transferred, and specify the quantity of tritium or promethium-147 in each kind of device. If no transfers have been made to the NRC or particular Agreement state during the reporting period, this information shall be reported to the NRC and responsible Agreement state agency.

E. Special requirements for license to manufacture or initially transfer calibration sources containing americium-241, plutonium or radium-226 for distribution to persons generally licensed under 12VAC5-481-430 F. An application for a specific license to manufacture calibration and reference sources containing americium-241, plutonium or radium-226 to persons generally licensed under 12VAC5-481-430 F will be approved if:

1. The applicant satisfies the general requirement of 12VAC5-481-450.

2. The applicant submits sufficient information regarding each type of calibration or reference source pertinent to evaluation of the potential radiation exposure, including:

a. Chemical and physical form and maximum quantity of americium 241 or radium-226 in the source;

b. Details of construction and design;

c. Details of the method of incorporation and binding of the americium-241 or radium-226 in the source;

d. Procedures for and results of prototype testing of sources, which are designed to contain more than 0.005 microcurie (0.185 kilobecquerel) of americium-241 or radium-226, to demonstrate that the americium-241 or radium-226 contained in each source will not be released or be removed from the source under normal conditions of use;

e. Details of quality control procedures to be followed in manufacture of the source;

f. Description of labeling to be affixed to the source or the storage container for the source; and

g. Any additional information, including experimental studies and tests, required by the NRC to facilitate a determination of the safety of the source.

3. Each source will contain no more than 5 microcuries of americium-241 or radium-226.

4. The agency determines, with respect to any type of source containing more than 0.005 microcurie (0.185 kilobecquerel) of americium-241 or radium-226, that:

a. The method of incorporation and binding of the americium-241 or radium-226 in the source is such that the americium-241 will not be released or be removed from the source under normal conditions of use and handling of the source; and

b. The source has been subjected to and has satisfactorily passed appropriate tests required by subdivision 5 of this subsection.

5. The applicant shall subject at least five prototypes of each source that is designed to contain more than 0.005 microcurie (0.185 kilobecquerel) of americium-241 or radium-226 to tests as follows:

a. The initial quantity of radioactive material deposited on each source is measured by direct counting of the source.

b. The sources are subjected to tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment or binding of americium-241 or radium-226, such as physical handling, moisture, and water immersion.

c. The sources are inspected for evidence of physical damage and for loss of americium-241 or radium-226 after each stage of testing using methods of inspection adequate for determining compliance with the criteria in subdivision 5 d of this subsection.

d. Source designs are rejected for which the following has been detected for any unit (i) removal of more than 0.005 microcurie (0.185 kilobecquerel) of americium-241 or radium-226 from the source or (ii) any other evidence of physical damage.

6. Labeling of devices. Each person licensed under this subsection shall affix to each source or storage container for the source a label that shall contain sufficient information relative to safe use and storage of the source and shall include the following statement or a substantially similar statement which contains the information in the following statement:

"The receipt, possession, use, and transfer of this source, Model, Serial No., are subject to a general license and the regulations of the U.S. Nuclear Regulatory Commission (NRC) or of a state with which the NRC has entered into an agreement for the exercise of regulatory authority. Do not remove this label.

CAUTION - RADIOACTIVE MATERIAL - THIS SOURCE CONTAINS AMERICIUM-241 (or RADIUM-226). DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.

---

(Name of manufacturer or initial transferor)"

7. Leak testing of each source. Each person licensed under this subsection shall perform a dry wipe test upon each source containing more than 0.1 microcurie (3.7 kilobecquerel) of americium-241 or radium-226 before transferring the source to a general licensee under 12VAC5-481-430 F or under equivalent regulations of the NRC or another Agreement state. This test shall be performed by wiping the entire radioactive surface of the source with a filter paper with the application of moderate finger pressure. The radioactivity on the filter paper shall be measured using methods capable of detecting 0.005 microcurie (0.185 kilobecquerel) of americium-241 or radium-226. If a source has been shown to be leaking or losing more than 0.005 microcurie (0.185 kilobecquerel) of americium-241 or radium-226 by the methods described in this section, the source shall be rejected and shall not be transferred to a general licensee under 12VAC5-481-430 F, or equivalent regulations of the NRC or another Agreement state.

F. Reserved.

G. Manufacture and distribution of radioactive material for certain in vitro clinical or laboratory testing under general license. An application for a specific license to manufacture or distribute radioactive material for use under the general license of 12VAC5-481-430 G will be approved if:

1. The applicant satisfies the general requirements specified in 12VAC5-481-450.

2. The radioactive material is to be prepared for distribution in prepackaged units of:

a. Carbon-14 in units not exceeding 370 kBq (10 μCi) each.

b. Cobalt-57 in units not exceeding 370 kBq (10 μCi) each.

c. Hydrogen-3 (tritium) in units not exceeding 1.85 MBq (50 μCi) each.

d. Iodine-125 in units not exceeding 370 kBq (10 μCi) each.

e. Mock iodine-125 in units not exceeding 1.85 kBq (0.05 μCi) of iodine-129 and 185 Bq (0.005 μCi) of americium-241 each.

f. Iodine-131 in units not exceeding 370 kBq (10 μCi) each.

g. Iron-59 in units not exceeding 740 kBq (20 μCi) each.

h. Selenium-75 in units not exceeding 370 kBq (10 μCi) each.

3. Each prepackaged unit bears a durable, clearly visible label:

a. Identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed 370 kBq (10 μCi) of iodine-125, iodine-131, carbon-14, cobalt-57, or selenium-75; 1.85 MBq (50 μCi) of hydrogen-3 (tritium); 740 kBq (20 μCi) of iron-59; or mock iodine-125 in units not exceeding 1.85 kBq (0.05 μCi) of iodine-129 and 185 Bq (0.005 μCi) of americium-241 each; and

b. Displaying the radiation caution symbol described in 12VAC5-481-850 and the words, "CAUTION, RADIOACTIVE MATERIAL," and "Not for Internal or External Use in Humans or Animals."

4. One of the following statements, as appropriate, or a substantially similar statement that contains the information called for in one of the following statements, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure that accompanies the package:

a. This radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the Nuclear Regulatory Commission or of a state with which the Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority.

____________________ Name of manufacturer

b. This radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of a licensing state.

____________________ Name of manufacturer

5. The label affixed to the unit, or the leaflet or brochure which accompanies the package, contains adequate information as to the precautions to be observed in handling and storing such radioactive material. In the case of the Mock Iodine-125 reference or calibration source, the information accompanying the source shall also contain directions to the licensee regarding the waste disposal requirements set out in 12VAC5-481-910.

H. Licensing the manufacture and distribution of ice detection devices. An application for a specific license to manufacture and distribute ice detection devices to persons generally licensed under 12VAC5-481-430 H will be approved if:

1. The applicant satisfies the general requirements of 12VAC5-481-450;

2. The applicant submits sufficient information regarding each type of device pertinent to evaluation of the potential radiation exposure, including:

a. Chemical and physical form and maximum quantity of strontium-90 in the device;

b. Details of construction and design of the source of radiation and its shielding;

c. Radiation profile of a prototype device;

d. Procedures for and results of prototype testing of devices to demonstrate that the strontium-90 contained in each device will not be released or be removed from the device under the most severe conditions likely to be encountered in normal handling and use;

e. Details of quality control procedures to be followed in manufacture of the device;

f. Description of labeling to be affixed to the device;

g. Instructions for handling and installation of the device;

h. Any additional information, including experimental studies and tests, required by the agency to facilitate a determination of the safety of the device;

3. Each device will contain no more than 50 microcuries of strontium-90 in an insoluble form;

4. Each device will bear durable, legible labeling that includes the radiation caution symbol prescribed by 12VAC5-481-850, a statement that the device contains strontium-90 and the quantity thereof, instructions for disposal and statements that the device may be possessed pursuant to a general license, that the manufacturer or civil authorities should be notified if the device is found, that removal of the labeling is prohibited, and that disassembly and repair of the device may be performed only by a person holding a specific license to manufacture or service such devices;

5. The agency determines that:

a. The method of incorporation and binding of the strontium-90 in the device is such that the strontium-90 will not be released from the device under the most severe conditions that are likely to be encountered in normal use and handling of the device;

b. The strontium-90 is incorporated or enclosed so as to preclude direct physical contact by any individual with it and is shielded so that no individual will receive a radiation exposure to a major portion of his body in excess of 0.5 rem in a year under ordinary circumstances of use;

c. The device is so designed that it cannot be easily disassembled;

d. Prototypes of the device have been subjected to and have satisfactorily passed the tests required by subdivision 6 of this subsection;

e. Quality control procedures have been established to satisfy the requirements of subdivision 8 of this subsection;

6. The applicant shall subject at least five prototypes of the device to tests as follows:

a. The devices are subjected to tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment of strontium-90, such as temperature, moisture, absolute pressure, water immersion, vibration, shock, and weathering.

b. The devices are inspected for evidence of physical damage and for loss of strontium-90 after each stage of testing, using methods of inspection adequate for determining compliance with the criteria in subdivision 6 c of this subsection.

c. Device designs are rejected for which the following has been detected for any unit:

(1) A leak resulting in a loss of 0.1% or more of the original amount of strontium-90 from the device;

(2) Surface contamination of strontium-90 on the device of more than 2,200 disintegrations per minute per 100 square centimeters of surface area; or

(3) Any other evidence of physical damage;

7. The device has been registered in the Sealed Source and Device Registry; and

8. Quality assurance; prohibition of transfer.

a. Each person licensed under this subsection shall visually inspect each device and shall reject any that has an observable physical defect that could affect containment of the strontium-90.

b. Each person licensed under this subsection shall test each device for possible loss of strontium-90 or for contamination by wiping with filter paper an area of at least 100 square centimeters on the outside surface of the device, or by wiping the entire surface area if it is less than 100 square centimeters. The detection on the filter paper of more than 2,200 disintegrations per minute of radioactive material per 100 square centimeters of surface wiped shall be cause for rejection of the tested device.

c. Each person licensed under this subsection shall:

(1) Maintain quality assurance systems in the manufacture of the ice detection device containing strontium-90 in a manner sufficient to provide reasonable assurance that the safety-related components of the distributed devices are capable of performing their intended functions; and

(2) Subject inspection lots to acceptance sampling procedures by procedures specified in subdivision 8 d of this subsection and in the license issued under this subsection, to provide at least 95% confidence that the lot tolerance percent defective of 5.0% will not be exceeded.

d. Each person licensed under this subsection shall subject each inspection lot to:

(1) Tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could possibly affect the effective containment of strontium-90, such as absolute pressure and water immersion.

(2) Inspection for evidence of physical damage, containment failure, or for loss of strontium-90 after each stage of testing using methods of inspection adequate to determine compliance with the following criteria for defective (i) a leak resulting in a loss of 0.1% or more of the original amount of strontium-90 from the device and (ii) any other criteria specified in the license issued under this subsection.

e. No person licensed under this subsection shall transfer to persons generally licensed under 12VAC5-481-430 H, or under an equivalent general license of the NRC or another Agreement state:

(1) Any ice detection device containing strontium-90 tested and found defective under the criteria specified in a license issued under this subsection unless the defective ice detection device has been repaired or reworked, retested, and determined by an independent inspector to meet the applicable acceptance criteria; or

(2) Any ice detection device containing strontium-90 contained within any lot that has been sampled and rejected as a result of the procedures in subdivision 8 c (2) of this subsection, unless:

(i) A procedure for defining sub-lot size, independence, and additional testing procedures is contained in the license issued under this subsection; and

(ii) Each individual sub-lot is sampled, tested, and accepted in accordance with subdivisions 8 c (2) and 8 e (2) (i) of this subsection and any other criteria as may be required as a condition of the license issued under this subsection.

I. Manufacture, preparation, or transfer for commercial distribution of drugs containing radioactive material for medical use under Part VII (12VAC5-481-1660 et seq.) of this chapter.

1. An application for a specific license to manufacture, prepare, or transfer for commercial distribution drugs containing radioactive material for use by persons authorized pursuant to Part VII (12VAC5-481-1660 et seq.) of this chapter will be approved if:

a. The applicant satisfies the general requirements specified in 12VAC5-481-450;

b. The applicant submits evidence that the applicant is at least one of the following:

(1) Registered with the U.S. Food and Drug Administration (FDA) as the owner or operator of a drug establishment that engages in the manufacture, preparation, propagation, compounding, or processing of a drug under 21 CFR 207.20(a);

(2) Registered or licensed with a state agency as a drug manufacturer;

(3) Licensed as a pharmacy by the Virginia Board of Pharmacy;

(4) Operating as a nuclear pharmacy within a federal medical institution; or

(5) A PET drug production facility registered with a state agency;

c. The applicant submits information on the radionuclide; the chemical and physical form; the maximum activity per vial, syringe, generator, or other container of the radioactive drug; and the shielding provided by the packaging to show it is appropriate for the safe handling and storage of the radioactive drugs by medical use licensees; and

d. The applicant commits to the following labeling requirements:

(1) A label is affixed to each transport radiation shield, whether it is constructed of lead, glass, plastic, or other material, of a radioactive drug to be transferred for commercial distribution. The label shall include the radiation symbol as described in 12VAC5-481-850 and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL"; the name of the radioactive drug or its abbreviation; and the quantity of radioactivity at a specified date and time. For radioactive drugs with a half-life greater than 100 days, the time may be omitted.

(2) A label is affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution. The label shall include the radiation symbol as described in 12VAC5-481-850 and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL" and an identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label.

2. A licensee authorized to manufacture, prepare or transfer for commercial distribution radioactive drugs shall ensure that any individual preparing the drugs is one of the following:

a. An authorized nuclear pharmacist (ANP) as defined in 12VAC5-481-10;

b. An individual who meets the requirements specified in 12VAC5-481-1770 and 12VAC5-481-1790, and the licensee has received an approved license amendment identifying this individual as an ANP;

c. A pharmacist, as defined in 12VAC5-481-10, designated as an ANP if:

(1) The individual was a nuclear pharmacist preparing only radioactive drugs containing accelerator-produced radioactive material; and

(2) The individual practiced at a pharmacy at a government agency or federally recognized Indian Tribe before November 30, 2007, or at all other pharmacies before August 8, 2009, or an earlier date as noticed by the NRC; or

d. An individual under the supervision of an ANP as specified in 12VAC5-481-1710.

3. Shall provide to the agency no later than 30 days after the date that the licensee allows, under subdivision 2 a or c of this subsection, the individual to work as an ANP:

a. The individual's certification by a specialty board whose certification process has been recognized by the NRC as specified in 12VAC5-481-1770;

b. An NRC or another Agreement state license;

c. NRC master materials licensee permit;

d. The permit issued by a licensee or NRC master materials permittee of broad scope or the authorization from a commercial nuclear pharmacy authorized to list its own authorized nuclear pharmacist; or

e. Documentation that only accelerator-produced radioactive materials were used in the practice of nuclear pharmacy at a government agency or federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC; and

f. The Virginia Board of Pharmacy's license.

4. A licensee shall possess and use instrumentation to measure the radioactivity of radioactive drugs. The licensee shall have procedures for use of the instrumentation. The licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha, beta, or photon-emitting radioactive drugs prior to transfer for commercial distribution. In addition, the licensee shall:

a. Perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument; and make adjustments when necessary; and

b. Check each instrument for constancy and proper operation at the beginning of each day of use.

5. A licensee shall satisfy the labeling requirements in subsection I 1 d of this section.

6. Nothing in this subsection relieves the licensee from complying with applicable FDA, other federal, and state requirements governing radioactive drugs.

7. Each licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium-99m generators or rubidium-82 from strontium-82/ryubidium-82 generators shall test the generator eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85 contamination in accordance with 12VAC5-481-1930. The licensee shall record the results of each test and retain each record for three years after the record is made.

J. Manufacture and distribution of sources or devices containing radioactive material for medical use. An application for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed pursuant to Part VII (12VAC5-481-1660 et seq.) of this chapter for the medical use of radioactive material or use as a calibration, transmission or reference source will be approved if:

1. The applicant satisfies the general requirements in 12VAC5-481-450;

2. The applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including:

a. The radioactive material contained, its chemical and physical form, and amount;

b. Details of design and construction of the source or device;

c. Procedures for, and results of, prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents;

d. For devices containing radioactive material, the radiation profile of a prototype device;

e. Details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests;

f. Procedures and standards for calibrating sources and devices;

g. Legend and methods for labeling sources and devices as to their radioactive content; and

h. Instructions for handling and storing the source or device from the radiation safety standpoint; these instructions are to be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device provided, that instructions that are too lengthy for such label may be summarized on the label and printed in detail on a brochure that is referenced on the label;

3. The label affixed to the source or device, or to the permanent storage container for the source or device, contains information on the radionuclide, quantity, and date of assay, and a statement that the source or device is licensed by the agency for distribution to persons licensed pursuant to Part VII (12VAC5-481-1660 et seq.) of this chapter for the medical use of radioactive material or under equivalent licenses of the NRC, or another Agreement state, provided that such labeling for sources that do not require long-term storage may be on a leaflet or brochure that accompanies the source;

4. In the event the applicant desires that the source or device be required to be tested for leakage of radioactive material at intervals longer than six months, the applicant shall include sufficient information to demonstrate that such longer interval is justified by performance characteristics of the source or device or similar sources or devices and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the source;

5. In determining the acceptable interval for test of leakage of radioactive material, the agency will consider information that includes, but is not limited to:

a. Primary containment or source capsule;

b. Protection of primary containment;

c. Method of sealing containment;

d. Containment construction materials;

e. Form of contained radioactive material;

f. Maximum temperature withstood during prototype tests;

g. Maximum pressure withstood during prototype tests;

h. Maximum quantity of contained radioactive material;

i. Radiotoxicity of contained radioactive material; and

j. Operating experience with identical sources or devices or similarly designed and constructed sources or devices; and

6. The device has been registered in the Sealed Source and Device Registry.

K. Requirements for license to manufacture and distribute industrial products containing depleted uranium for mass-volume applications.

1. An application for a specific license to manufacture industrial products and devices containing depleted uranium for use pursuant to 12VAC5-481-420 C or equivalent regulations of the NRC or another Agreement state will be approved if:

a. The applicant satisfies the general requirements specified in 12VAC5-481-450;

b. The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, proposed uses, and potential hazards of the industrial product or device to provide reasonable assurance that possession, use, or transfer of the depleted uranium in the product or device is not likely to cause any individual to receive in any period of one calendar quarter a radiation dose in excess of 10% of the limits specified in 12VAC5-481-640; and

c. The applicant submits sufficient information regarding the industrial product or device and the presence of depleted uranium for a mass-volume application in the product or device to provide reasonable assurance that unique benefits will accrue to the public because of the usefulness of the product or device.

2. In the case of an industrial product or device whose unique benefits are questionable, the agency will approve an application for a specific license under this subsection only if the product or device is found to combine a high degree of utility and low probability of uncontrolled disposal and dispersal of significant quantities of depleted uranium into the environment.

3. The agency may deny any application for a specific license under this subsection if the end use or uses of the industrial product or device cannot be reasonably foreseen.

4. Each person licensed pursuant to subdivision 1 of this subsection shall:

a. Maintain the level of quality control required by the license in the manufacture of the industrial product or device, and in the installation of the depleted uranium into the product or device;

b. Label or mark each unit to:

(1) Identify the manufacturer or initial transferor of the product or device and the number of the license under which the product or device was manufactured or initially transferred, the fact that the product or device contains depleted uranium, and the quantity of depleted uranium in each product or device; and

(2) State that the receipt, possession, use, and transfer of the product or device are subject to a general license or the equivalent and the regulations of the NRC or another Agreement state;

c. Assure that the depleted uranium before being installed in each product or device has been impressed with the following legend clearly legible through any plating or other covering: "Depleted Uranium";

d. Do the following:

(1) Furnish a copy of the general license contained in 12VAC5-481-420 C and a copy of agency form "Certificate - Use of Depleted Uranium under a General License" to each person to whom depleted uranium in a product or device for use pursuant to the general license contained in 12VAC5-481-420 C is transferred; or

(2) Furnish a copy of the general license contained in the NRC's or another Agreement state's regulation equivalent to 12VAC5-481-420 B and a copy of the NRC's or another Agreement state's certificate, or alternatively, furnish a copy of the general license contained in 12VAC5-481-420 C and a copy of agency form "Certificate - Use of Depleted Uranium under a General License" to each person to whom depleted uranium in a product or device for use pursuant to the general license of the NRC or another Agreement state is transferred, with a note explaining that use of the product or device is regulated by the NRC or another Agreement state under requirements substantially the same as those in 12VAC5-481-420 C;

e. Report to the agency all transfers of industrial products or devices to persons for use under the general license in 12VAC5-481-420 C. Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the agency and the general licensee, the type and model number of device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within 30 days after the end of each calendar quarter in which such a product or device is transferred to the generally licensed person. If no transfers have been made to persons generally licensed under 12VAC5-481-420 C during the reporting period, the report shall so indicate;

f. Do the following:

(1) Report to the NRC all transfers of industrial products or devices to persons for use under the NRC general license in 10 CFR 40.25;

(2) For devices transferred to another Agreement state, report to the responsible state agency all transfers of devices manufactured and distributed pursuant to this subsection for use under a general license in that state's regulations equivalent to 12VAC5-481-420 C;

(3) Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the agency and the general licensee, the type and model number of the device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within 30 days after the end of each calendar quarter in which such product or device is transferred to the generally licensed person;

(4) If no transfers have been made to NRC licensees during the reporting period, this information shall be reported to the NRC; and

(5) If no transfers have been made to general licensees within another Agreement state during the reporting period, this information shall be reported to the responsible state agency upon the request of that agency; and keep records showing the name, address, and point of contact for each general licensee to whom he transfers depleted uranium in industrial products or devices for use pursuant to the general license provided in 12VAC5-481-420 C or equivalent regulations of the NRC or another Agreement state. The records shall be maintained for a period of two years and shall show the date of each transfer, the quantity of depleted uranium in each product or device transferred, and compliance with the report requirements of this section.

L. Serialization of nationally tracked sources. Each licensee who manufactures a nationally tracked source shall assign a unique serial number to each nationally tracked source. Serial numbers shall be composed only of alpha-numeric characters.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 25, Issue 2, eff. November 1, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 33, Issue 11, eff. February 22, 2017; Volume 37, Issue 25, eff. January 14, 2022.

12VAC5-481-490 Issuance of specific licenses

A. Upon a determination that an application meets the requirements of the Act and the regulations of the agency, the agency will issue a specific license authorizing the proposed activity in such form and containing such conditions and limitations as it deems appropriate or necessary.

B. The agency may incorporate in any license at the time of issuance, or thereafter by appropriate rule, regulation, or order, such additional requirements and conditions with respect to the licensee's receipt, possession, use, and transfer of radioactive material subject to this part as it deems appropriate or necessary in order to:

1. Minimize danger to public health and safety or property;

2. Require such reports and the keeping of such records, and to provide for such inspections of activities under the license as may be appropriate or necessary; and

3. Prevent loss or theft of material subject to this part.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-500 Specific terms and conditions of licenses

A. Each license issued pursuant to this part shall be subject to all the provisions of the Act, now or hereafter in effect, and to all rules, regulations, and orders of the agency.

B. No license issued or granted under this part and no right to possess or utilize radioactive material granted by any license issued pursuant to this part shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person unless the agency shall, after securing full information find that the transfer is in accordance with the provisions of the Act, now or hereafter in effect, and to all valid rules, regulations, and orders of the agency, and shall give its consent in writing.

A request for license transfer shall include (i) the identity, technical, and financial qualifications of the proposed transferee and (ii) financial assurance for decommissioning information required under 12VAC5-481-450 C.

C. Each person licensed by the agency pursuant to this part shall confine use and possession of the material licensed to the locations and purposes authorized in the license.

D. Each licensee shall notify the agency in writing when the licensee decides to permanently discontinue all activities involving materials authorized under the license.

E. Each licensee shall notify the agency in writing immediately following the filing of a voluntary or involuntary petition for bankruptcy under any Chapter of Title 11 (Bankruptcy) of the United States Code by or against:

1. The licensee;

2. An entity (as that term is defined in 11 USC § 101(15)) controlling the licensee or listing the license or licensee as property of the estate; or

3. An affiliate (as that term is defined in 11 USC § 101(2)) of the licensee.

F. The notification specified in subsection E of this section shall indicate the bankruptcy court in which the petition for bankruptcy was filed and the date of the filing of the petition.

G. PET Distribution.

1. Authorization under 12VAC5-481-440 H to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium does not relieve the licensee from complying with applicable FDA, other state or local requirements governing radioactive drugs.

2. Each licensee authorized under 12VAC5-481-440 H to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium shall:

a. Satisfy the labeling requirements in 12VAC5-481-480 I 1 d for each PET radioactive drug transport radiation shield and each syringe, vial, or other container used to hold a PET radioactive drug intended for noncommercial distribution to members of its consortium.

b. Possess and use instrumentation to measure the radioactivity of the PET radioactive drugs intended for noncommercial distribution to members of its consortium and meet the procedural, radioactivity measurement, instrument test, instrument check, and instrument adjustment requirements in 12VAC5-481-480 I 3.

3. A licensee that is a pharmacy authorized under 12VAC5-481-440 H to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium shall require that any individual that prepares PET radioactive drugs shall be:

a. An ANP that meets the requirements in 12VAC5-481-480 I 2; or

b. An individual under the supervision of an ANP as specified in 12VAC5-481-1710.

4. A pharmacy, authorized under 12VAC5-481-440 H to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium that allows an individual to work as an ANP, shall meet the requirements of 12VAC5-481-480 I 2.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-510 Expiration and termination of licenses and decommissioning of sites and separate building or outdoor areas

A. Except as provided in 12VAC5-481-520, a specific license shall expire at the end of the specified day in the month and year stated in the license. If an application for license renewal has been filed at least 30 days prior to the expiration date stated in the existing license and the agency denies the renewal application, the license shall expire on the date as stated in the determination of denial. If an application for license renewal is filed less than 30 days from the expiration date stated in the existing license, the agency may deny the renewal application and the license shall expire on the expiration date stated in the license.

B. A specific license revoked by the agency expires at the end of the day on the date of the agency's final determination, or on the expiration date stated in the determination, or as otherwise provided by an agency order.

C. A specific license remains valid, with respect to possession of radioactive material, until the agency notifies the licensee in writing that the license is terminated. While the license is valid, the licensee shall do all of the following:

1. Limit actions involving radioactive material to those related to decommissioning and other activities related to preparation for release for unrestricted use.

2. Continue to control entry to restricted areas until they are suitable for release for unrestricted use and the agency notifies the licensee in writing that the license is terminated.

D. A licensee shall do all of the following:

1. Notify the agency within 60 days of any of the following:

a. Expiration of the license pursuant to subsections A or B of this section.

b. The licensee's deciding to permanently cease principal activities at the entire site or in any separate building or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuitable for release in accordance with agency requirements.

c. The absence of conduct of any principal activities under the license for a period of 24 months.

d. The absence of conduct of any principal activities for a period of 24 months in any separate building or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuitable for release in accordance with agency requirements.

2. If any separate building or outdoor area contains residual radioactivity so that the building or outdoor area is unsuitable for release, do one of the following:

a. Begin decommissioning its site, separate building or outdoor area if a decommissioning plan has been previously approved by the agency.

b. Submit a decommissioning plan within 12 months if required by subsection F of this section and begin decommissioning upon approval of that plan.

E. Concurrent with the notification required by subsection D of this section, the licensee shall maintain in effect all decommissioning financial assurances established by the licensee pursuant to 12VAC5-481-450 C in conjunction with a license issuance or renewal or as required by this section. The amount of the financial assurance shall be increased, or may be decreased, as appropriate, to cover the detailed cost estimate for decommissioning established pursuant to subdivision H 5 of this section. Following approval of the decommissioning plan and with the agency's approval, a licensee may reduce the amount of the financial assurance as decommissioning proceeds and radiological contamination is reduced at the site.

F. A licensee shall submit a decommissioning plan to the agency if required by license condition or if the procedures and activities necessary to carry out decommissioning of the site, separate building or outdoor area have not been previously approved by the agency and the procedures and activities may adversely effect the health and safety of workers or the public. The procedures may not be carried out prior to the agency's approval of the decommissioning plan. Examples of applicable procedures and activities include any of the following cases:

1. Procedures that would involve techniques not applied routinely during cleanup or maintenance operations.

2. Procedures by which workers would be entering areas not normally occupied where surface contamination and radiation levels are significantly higher than routinely encountered during operation.

3. Procedures that could result in significantly greater airborne concentrations of radioactive materials than are present during operation.

4. Procedures that could result in significantly greater releases of radioactive material to the environment than those associated with operation.

G. The agency may approve an alternate schedule for submittal of a decommissioning plan required pursuant to subsection D of this section if the agency determines that the alternative schedule is necessary to the effective conduct of decommissioning operations and presents no undue risk from radiation to the public health and safety and is otherwise in the public interest.

H. The proposed decommissioning plan for the site or separate building or outdoor area shall include all of the following elements:

1. A description of the conditions of the site, separate building or outdoor area sufficient to evaluate the acceptability of the plan.

2. A description of planned decommissioning activities.

3. A description of methods used to ensure protection of workers and the environment against radiation hazards during decommissioning.

4. A description of the planned final radiation survey.

5. An updated detailed cost estimate for decommissioning, comparison of that estimate with present funds set aside for decommissioning, and a plan for assuring the availability of adequate funds for completion of decommissioning.

6. For decommissioning plans calling for completion of decommissioning later than 24 months after plan approval, a justification for the delay based on the criteria in subsection J of this section.

I. Except as provided in subsection H of this section, a licensee shall complete decommissioning of the site or separate building or outdoor area no later than 24 months following the initiation of decommissioning. When decommissioning involves the entire site, a licensee shall request license termination no later than 24 months following the initiation of decommissioning.

J. The agency may approve a request for an alternative schedule for completion of decommissioning of the site, separate building or outdoor area, and license termination if appropriate, if the agency determines that the alternative is warranted after consideration of all the following:

1. Whether it is technically feasible to complete decommissioning within the allotted 24-month period.

2. Whether sufficient waste disposal capacity is available to allow completion of decommissioning within the allotted 24-month period.

3. Whether a significant volume reduction in wastes requiring disposal will be achieved by allowing short-lived radionuclides to decay.

4. Whether a significant reduction in radiation exposure to workers may be achieved by allowing short-lived radionuclides to decay.

5. Other site-specific factors which the agency may consider appropriate on a case-by-case basis, such as the regulatory requirements of other government agencies, court decisions, ground-water treatment activities, monitored natural ground-water restoration, actions that could result in more environmental harm than deferred cleanup, and other factors beyond the control of the licensee.

K. As the final step in decommissioning, a licensee shall do all the following:

1. Certify the disposition of all licensed material, including accumulated wastes, by submitting a completed agency form for disposition of radioactive materials or equivalent information.

2. Conduct a radiation survey of the premises where the licensed activities were carried out and submit a report of the results of this survey, unless the licensee demonstrates in some other manner that the premises are suitable for release in accordance with the criteria for decommissioning in 12VAC5-481-1161.

3. Report levels of gamma radiation in units of millisieverts (microroentgen) per hour at one meter from surfaces, and report levels of radioactivity, including alpha and beta, in units of megabecquerels per 100 square centimeters, disintegrations per minute per 100 square centimeters or microcuries per 100 square centimeters - removable and fixed - for surfaces, megabecquerels (microcuries) per milliliter for water, and becquerels (picocuries) per gram for solids such as soils or concrete.

4. Specify the survey instruments used and certify that each instrument is properly calibrated and tested.

L. The agency shall terminate a specific license, including an expired license, by written notice to the licensee when the agency determines all of the following have occurred:

1. Radioactive material has been properly disposed of.

2. Reasonable effort has been made to eliminate residual radioactive contamination, if present.

3. The licensee has filed with the agency sufficient information, including a radiation survey, to demonstrate that the premises are suitable for release in accordance with the criteria for decommissioning in 12VAC5-481-1161.

4. The licensee has submitted records required under 12VAC5-481-571 to the agency.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-520 Renewal of licenses

A. Applications for renewal of specific licenses shall be filed in accordance with 12VAC5-481-440.

B. In any case in which a licensee, not less than 30 days prior to expiration of his existing license, has filed an application in proper form for renewal or for a new license authorizing the same activities, such existing license shall not expire until final action by the agency.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-530 Amendment of licenses at request of licensee

Amendment requests for a license shall be filed in accordance with 12VAC5-481-440 and shall specify the respects in which the licensee desires the license to be amended and the grounds for such amendment.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-540 Agency action on applications to renew or amend

In considering an application by a licensee to renew or amend the license, the agency will apply the criteria set forth in 12VAC5-481-450 through 12VAC5-481-480 and in Parts V (12VAC5-481-1170 et seq.), VII (12VAC5-481-1660 et seq.), XI (12VAC5-481-2330 et seq.), XII (12VAC5-481-2660 et seq.), XIV (12VAC5-481-3140 et seq.), or XVI (12VAC5-481-3460 et seq.) of this chapter, as applicable.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 5 Licenses Held at the Time of the Effective Date of These Regulations

12VAC5-481-550 Persons possessing a license for source, byproduct, or special nuclear material in quantities not sufficient to form a critical mass on effective date

Article 5 Licenses Held at the Time of the Effective Date of These Regulations

Any person who, on the effective date as stated in 12VAC5-481-160, possesses a general or specific license for source, byproduct, or special nuclear material in quantities not sufficient to form a critical mass, issued by the NRC, shall be deemed to possess a like license issued under this part and the Act, such license to expire either 90 days after receipt from the agency of a notice of expiration of such license, or on the date or expiration specified in the NRC license, whichever is earlier.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-560 Persons possessing NARM on effective date of these regulations

Any person who, on September 20, 2006, possesses NARM for which a specific license is required by the Act or this part shall be deemed to possess such a license issued under the Act and this part. Such license shall expire 90 days after September 20, 2006; provided, however, that if within the 90 days the person possessing such material files an application in proper form for a license, such existing license shall not expire until the application has been finally determined by the agency.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 6 Transfer of Material

12VAC5-481-570 Transfer of material

Article 6 Transfer of Material

A. No licensee shall transfer radioactive material except as authorized pursuant to this section.

B. Except as otherwise provided in the license and subject to the provisions of subsections C and D of this section, any licensee may transfer radioactive material:

1. To the agency only after receiving prior approval from the agency.

2. To the United States Department of Energy;

3. To any person exempt from these regulations to the extent permitted under such exemption;

4. To any person authorized to receive such material under terms of a general license or its equivalent, or a specific license or equivalent licensing document, issued by the agency, the NRC, or another agreement state, or to any person otherwise authorized to receive such material by the federal government or any agency thereof, the agency, or another agreement state; or

5. As otherwise authorized by the agency in writing.

C. Before transferring radioactive material to a specific licensee of the agency, the NRC, or another agreement state, or to a general licensee who is required to register with the agency, the NRC, or another agreement state prior to receipt of the radioactive material, the licensee transferring the material shall verify that the transferee's license authorizes the receipt of the type, form, and quantity of radioactive material to be transferred.

D. Any of the following methods for the verification required by subsection C of this section is acceptable:

1. The transferor may possess and read a current copy of the transferee's specific license or registration certificate.

2. The transferor may possess a written certification by the transferee that the transferee is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, specifying the license or registration certificate number, issuing agency, and expiration date.

3. For emergency shipments, the transferor may accept oral certification by the transferee that the transferee is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, specifying the license or registration certificate number, issuing agency, and expiration date; provided that the oral certification is confirmed in writing within 10 days.

4. The transferor may obtain other information compiled by a reporting service from official records of the agency, the NRC, or another agreement state, regarding the identity of licensees and the scope and expiration dates of licenses and registration.

5. When none of the methods of verification described in subdivisions 1 through 4 of this subsection are readily available or when a transferor desires to verify that information received by one of such methods is correct or up to date, the transferor may obtain and record confirmation from the agency, the NRC, or another agreement state, that the transferee is licensed to receive the radioactive material.

E. Shipment and transport of radioactive material shall be in accordance with the provisions of Part XIII (12VAC5-481-2950 et seq.) of this chapter.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 7 Records

12VAC5-481-571 Receipt, transfer and disposal records

Article 7 Records

A. Record retention . A licensee shall retain records required by 12VAC5-481-100 or by license condition. If a retention period is not otherwise specified by this chapter or license condition, the record shall be retained until the agency terminates each license.

B. Transfer of records to the agency . Prior to license termination, a licensee authorized to possess radioactive material, in an unsealed form, with a half-life greater than 120 days, shall forward to the agency all records of disposal of licensed material made under 12VAC5-481-910 to 12VAC5-481-950, including burials authorized before January 28, 1981, and the results of measurements and calculations required by 12VAC5-481-1000.

C. Transfer of records to new licensee.

1. If licensed activities are transferred or assigned in accordance with 12VAC5-481-570, each licensee authorized to possess radioactive material in unsealed form, with a half-life greater than 120 days, shall transfer the following records to the new licensee:

a. Records of disposal of licensed material made under 12VAC5-481-910 to 12VAC5-481-950, including burials authorized before January 28, 1981.

b. Records of the results of measurements and calculations required by12VAC5-481-1000.

2. The new licensee shall be responsible for maintaining the records required in subdivision C 1 of this section until the license is terminated.

D. Transfer of records of decommissioning activities . A licensee shall forward the records required by 12VAC5-481-450 C to the agency prior to license termination.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 8 Modification and Revocation of Licenses

12VAC5-481-580 Modification and revocation of licenses

Article 8 Modification and Revocation of Licenses

A. The terms and conditions of all licenses shall be subject to amendment, revision, or modification or the license may be suspended or revoked by reason of amendments to the Act, or by reason of rules, regulations, and orders issued by the agency.

B. Any license may be revoked, suspended, or modified, in whole or in part, for any false statement in the application or any statement of fact required under provisions of the Act, or because of conditions revealed by such application or statement of fact or any report, record, or inspection or other means that would warrant the agency to refuse to grant a license on an original application, or for violation of, or failure to observe any of the terms and conditions of the Act, or of the license, or of any rule, regulation, or order of the agency.

C. Except in cases of willfulness or those in which the public health, interest or safety requires otherwise, no license shall be modified, suspended, or revoked unless, prior to the institution of proceedings therefor, facts or conduct that may warrant such action shall have been called to the attention of the licensee in writing and the licensee shall have been accorded an opportunity to demonstrate or achieve compliance with all lawful requirements.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 9 Reciprocity

12VAC5-481-590 Reciprocal recognition of licenses

Licenses of radioactive, source, and special nuclear material in quantities not sufficient to form a critical mass.

1. Subject to these regulations, any person who holds a specific license from the NRC or another Agreement state, and issued by the agency having jurisdiction where the licensee maintains an office for directing the licensed activity and at which radiation safety records are normally maintained, is hereby granted a general license to conduct the activities authorized in such licensing document within the Commonwealth for a period not in excess of 180 days during the one-year reciprocal approval period, provided that:

a. The licensing document does not limit the activity authorized by such document to specified installations or locations;

b. The out-of-state licensee notifies the agency using Applications for Reciprocal Recognition of Out-of-State Radioactive Materials License and Reciprocity Notification forms at least three days prior to engaging in such activity. Such notification shall indicate the location, period, and type of proposed possession and use within the state, and shall be accompanied by a copy of the pertinent licensing document. If, for a specific case, the three-day period would impose an undue hardship on the out-of-state licensee, the licensee may, upon application to the agency, obtain permission to proceed sooner. The agency may waive the requirement for filing additional written notifications during the remainder of the calendar year following the receipt of the initial notification from a person engaging in activities under the general license provided in this subdivision;

c. The out-of-state licensee complies with all applicable regulations of the agency and with all the terms and conditions of the licensing document, except any such terms and conditions that may be inconsistent with applicable regulations of the agency;

d. The out-of-state licensee supplies such other information as the agency may request;

e. The out-of-state licensee shall not transfer or dispose of radioactive material possessed or used under the general license provided in this subdivision except by transfer to a person:

(1) Specifically licensed by the agency, the NRC or another Agreement state to receive such material, or

(2) Exempt from the requirements for a license for such material under 12VAC5-481-400 A; and

f. The out-of-state licensee submits the payment required by 12VAC5-490-40 to the agency.

2. Notwithstanding the provisions of subdivision 1 of this section, any person who holds a specific license issued by the NRC or another Agreement state authorizing the holder to manufacture, transfer, install, or service a device described in 12VAC5-481-430 B within areas subject to the jurisdiction of the licensing body is hereby granted a general license to install, transfer, demonstrate, or service such a device in this state provided that:

a. Such person shall file a report with the agency within 30 days after the end of each calendar quarter in which any device is transferred to or installed in this state. Each such report shall identify each general licensee to whom such device is transferred by name and address, the type of device transferred, and the quantity and type of radioactive material contained in the device;

b. The device has been manufactured, labeled, installed, and serviced in accordance with applicable provisions of the specific license issued to such person by the NRC or another Agreement state;

c. Such person shall assure that any labels required to be affixed to the device under regulations of the authority which licensed manufacture of the device bear a statement that "Removal of this label is prohibited"; and

d. The holder of the specific license shall furnish to each general licensee to whom he transfers such device or on whose premises he installs such device a copy of the general license contained in 12VAC5-481-430 B or in equivalent regulations of the agency having jurisdiction over the manufacture and distribution of the device.

3. The agency may withdraw, limit, or qualify its acceptance of any specific license or equivalent licensing document issued by the NRC or another Agreement state, or any product distributed pursuant to such licensing document, upon determining that such action is necessary in order to prevent undue hazard to public health and safety or property.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022.

Article 1 General Provisions

12VAC5-481-600 Purpose

Article 1 General Provisions

A. Part IV (12VAC5-481-600 et seq.) of this chapter establishes standards for protection against ionizing radiation resulting from activities conducted pursuant to licenses or registrations issued by the agency. These regulations are issued pursuant to the Act, as amended.

B. The requirements of Part IV (12VAC5-481-600 et seq.) of this chapter are designed to control the receipt, possession, use, transfer, and disposal of sources of radiation by any licensee or registrant so the total dose to an individual, including doses resulting from all sources of radiation other than background radiation, does not exceed the standards for protection against radiation prescribed in Part IV (12VAC5-481-600 et seq.) of this chapter. However, nothing in Part IV (12VAC5-481-600 et seq.) of this chapter shall be construed as limiting actions that may be necessary to protect health and safety in an emergency.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-610 Scope

Except as specifically provided in other parts of these regulations, Part IV (12VAC5-481-600 et seq.) of this chapter applies to persons licensed or registered by the agency to receive, possess, use, transfer, or dispose of sources of radiation. The limits in Part IV (12VAC5-481-600 et seq.) of this chapter do not apply to doses due to background radiation, to exposure of patients to radiation for the purpose of medical diagnosis or therapy, or to voluntary participation in medical research programs.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-620 Implementation

A. Any existing license or registration condition that is more restrictive than Part IV (12VAC5-481-600 et seq.) of this chapter remains in force until there is an amendment or renewal of the license or registration.

B. If a license or registration condition exempts a licensee or registrant from a provision of Part IV (12VAC5-481-600 et seq.) of this chapter in effect on or before September 20, 2006, it also exempts the licensee or registrant from the corresponding provision of Part IV (12VAC5-481-600 et seq.) of this chapter.

C. If a license or registration condition cites provisions of Part IV (12VAC5-481-600 et seq.) of this chapter in effect prior to September 20, 2006, which do not correspond to any provisions of Part IV (12VAC5-481-600 et seq.) of this chapter, the license or registration condition remains in force until there is an amendment or renewal of the license or registration that modifies or removes this condition.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

Article 2 Radiation Protection Programs

12VAC5-481-630 Radiation protection programs

Article 2 Radiation Protection Programs

A. Each licensee shall develop, document, and implement a radiation protection program commensurate with the scope and extent of licensed activities and sufficient to ensure compliance with the provisions of this chapter.

B. The licensee shall use, to the extent practical, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and doses to members of the public that are as low as is reasonably achievable (ALARA).

C. The licensee shall periodically (not to exceed 12 months) review the radiation protection program content and implementation.

D. To implement the ALARA requirements of subsection B of this section, and notwithstanding the requirements of 12VAC5-481-720, a constraint on air emissions of radioactive material to the environment, excluding Radon-222 and its daughters, shall be established by licensees such that the individual member of the public likely to receive the highest dose will not be expected to receive a total effective dose equivalent in excess of 10 mrem (0.1 mSv) per year from these emissions. If a licensee subject to this requirement exceeds this dose constraint, the licensee shall report the exceedance as provided in 12VAC5-481-1110 and promptly take appropriate corrective action to ensure against recurrence.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

Article 3 Occupational Dose Limits

12VAC5-481-640 Occupational dose limits for adults

Article 3 Occupational Dose Limits

A. The licensee shall control the occupational dose to individual adults, except for planned special exposures under 12VAC5-481-690, to the following dose limits.

1. An annual limit, which is the more limiting of:

a. The total effective dose equivalent being equal to 5 rem (0.05 Sv); or

b. The sum of the deep-dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye being equal to 50 rem (0.5 Sv).

2. The annual limits to the lens of the eye, to the skin of the whole body, and to the skin of the extremities, which are:

a. A lens dose equivalent of 15 rem (0.15 Sv), and

b. A shallow-dose equivalent of 50 rem (0.5 Sv) to the skin of the whole body or to the skin of any extremity.

B. Doses received in excess of the annual limits, including doses received during accidents, emergencies, and planned special exposures, shall be subtracted from the limits for planned special exposures that the individual may receive during the current year and during the individual's lifetime in accordance with 12VAC5-481-690 A 5.

C. When the external exposure is determined by measurement with an external personal monitoring device, the deep-dose equivalent shall be used in place of the effective dose equivalent, unless the effective dose equivalent is determined by a dosimetry method approved by the agency. The assigned deep-dose equivalent shall be for the part of the body receiving the highest exposure. The assigned shallow-dose equivalent shall be the dose averaged over the contiguous 10 square centimeters of skin receiving the highest exposure. The deep-dose equivalent, lens-dose equivalent, and shallow-dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits if the individual monitoring device was not in the region of highest potential exposure or the results of individual monitoring are unavailable.

D. Derived air concentration (DAC) and annual limit on intake (ALI) values are presented in Appendix B to 10 CFR Part 20 and may be used to determine the individual's dose (see 12VAC5-481-1040) and to demonstrate compliance with the occupational dose limits.

E. In addition to the annual dose limits, the licensee shall limit the soluble uranium intake by an individual to 10 milligrams in a week in consideration of chemical toxicity (see Appendix B to 10 CFR Part 20).

F. The licensee shall reduce the dose that an individual may be allowed to receive in the current year by the amount of occupational dose received while employed by any other person (see 12VAC5-481-1020).

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-650 Compliance with requirements for summation of external and internal doses

A. If the licensee is required to monitor under subdivisions 1 and 2 of 12VAC5-481-760, the licensee shall demonstrate compliance with the dose limits by summing external and internal doses. If the licensee is required to monitor only under subdivision 1 of 12VAC5-481-760 or only under subdivision 2 of 12VAC5-481-760, then summation is not required to demonstrate compliance with the dose limits. The licensee may demonstrate compliance with the requirements for summation of external and internal doses by meeting one of the conditions specified in subsections B, C, and D of this section. The dose equivalents for the lens of the eye, the skin, and the extremities are not included in the summation, but are subject to separate limits.

B. Intake by inhalation. If the only intake of radionuclides is by inhalation, the total effective dose equivalent limit is not exceeded if the sum of the deep-dose equivalent divided by the total effective dose equivalent limit and one of the following does not exceed unity:

1. The sum of the fractions of the inhalation ALI for each radionuclide,

2. The total number of derived air concentration-hours (DAC-hours) for all radionuclides divided by 2,000, or

3. The sum of the calculated committed effective dose equivalents to all significantly irradiated organs or tissues calculated from bioassay data using appropriate biological models and expressed as a fraction of the annual limit. For the purposes of this requirement, an organ or tissue is deemed to be significantly irradiated if, for that organ or tissue, the product of the weighting factors and the committed dose equivalent per unit intake is greater than 10% of the maximum weighted value of the committed dose equivalent per unit intake of any organ or tissue.

C. Intake by oral ingestion. If the occupationally exposed individual also receives an intake of radionuclides by oral ingestion greater than 10% of the applicable oral ALI, the licensee shall account for this intake and include it in demonstrating compliance with the limits.

D. Intake through wounds or absorption through skin. The licensee shall evaluate and to the extent practical account for intakes through wounds or skin absorption. The intake through intact skin has been included in the calculation of DAC for hydrogen-3 and does not need to be evaluated.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-660 Determination of external dose from airborne radioactive material

A. Licensees shall, when determining the dose from airborne radioactive material, include the contribution to the deep-dose equivalent, lens dose equivalent, and shallow-dose equivalent from external exposure to the radioactive cloud (see Appendix B to 10 CFR Part 20).

B. Airborne radioactive measurements and DAC values shall not be used as the primary means to assess the deep dose equivalent when the airborne radioactive materials includes radionuclides other than noble gases or if the cloud of airborne radioactive material is not relatively uniform. The determination of the deep dose equivalent to an individual shall be based upon measurements using instruments or individual monitoring devices.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-670 Determination of internal exposure

A. For purposes of assessing dose used to determine compliance with occupational dose equivalent limits, the licensee shall, when required under 12VAC5-481-760, take suitable and timely measurements of either:

1. Concentrations of radioactive materials in air in work areas;

2. Quantities of radionuclides in the body;

3. Quantities of radionuclides excreted from the body; or

4. Combinations of these measurements.

B. Unless respiratory protective equipment is used as provided in 12VAC5-481-830 or the assessment of intake is based on bioassays, the licensee shall assume that an individual inhales radioactive material at the airborne concentration in which the individual is present.

C. When specific information on the physical and biochemical properties of the radionuclides taken into the body or the behavior or the material in an individual is known, the licensee may:

1. Use that information to calculate the committed effective dose equivalent, and if used, the licensee shall document that information in the individual's record;

2. Upon prior approval from the agency, adjust the DAC or ALI values to reflect the actual physical and chemical characteristics of airborne radioactive material (e.g., aerosol size distribution or density); and

3. Separately assess the contribution of fractional intakes of Class D, W, or Y compounds of a given radionuclide (see Appendix B to 10 CFR Part 20) to the committed effective dose equivalent.

D. If the licensee chooses to assess intakes of Class Y material using the measurements given in subdivision A 2 or A 3 of this section, the licensee may delay the recording and reporting of the assessments for periods up to seven months, unless otherwise required by 12VAC5-481-1100 or 12VAC5-481-1110, in order to permit the licensee to make additional measurements basic to the assessments.

E. If the identity and concentration of each radionuclide in a mixture are known, the fraction of the DAC applicable to the mixture for use in calculating DAC-hours shall be either:

1. The sum of the ratios of the concentration to the appropriate DAC value (e.g., D, W, or Y) from Appendix B to 10 CFR Part 20 for each radionuclide in the mixture; or

2. The ratio of the total concentration for all radionuclides in the mixture to the most restrictive DAC value for any radionuclide in the mixture.

F. If the identity of each radionuclide in a mixture is known, but the concentration of one or more of the radionuclides in the mixture is not known, the DAC for the mixture shall be the most restrictive DAC of any radionuclide in the mixture.

G. When a mixture of radionuclides in air exists, licensees may disregard certain radionuclides in the mixture if:

1. The licensee uses the total activity of the mixture in demonstrating compliance with the dose limits in 12VAC5-481-640 and in complying with the monitoring requirements in 12VAC5-481-760 A 2,

2. The concentration of any radionuclide disregarded is less than 10% of its DAC, and

3. The sum of these percentages for all of the radionuclides disregarded in the mixture does not exceed 30%.

H. When determining the committed effective dose equivalent, the following information may be considered:

1. In order to calculate the committed effective dose equivalent, the licensee may assume that the inhalation of one ALI or an exposure of 2,000 DAC-hours results in a committed effective dose equivalent of 5 rem (0.05 Sv) for radionuclides that have their ALIs or DACs based on the committed effective dose equivalent.

2. When the ALI and the associated DAC is determined by the nonstochastic organ dose limit of 50 rem (0.5 Sv), the intake of radionuclides that would result in a committed effective dose equivalent of 5 rem (0.05 Sv) (the stochastic ALI) is listed in parentheses of Appendix B to 10 CFR Part 20. In this case, the licensee may, as a simplifying assumption, use the stochastic ALIs to determine committed effective dose equivalent. However, if the licensee uses the stochastic ALIs, the licensee shall also demonstrate that the limit in 12VAC5-481-640 A 1 (b) is met.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-680 Determination of prior occupational dose

A. For each individual who may enter the licensee's or registrant's restricted area and is likely to receive, in a year, an occupational dose requiring monitoring pursuant to 12VAC5-481-760, the licensee or registrant shall determine the occupational radiation dose received during the current year.

B. Prior to permitting an individual to participate in a planned special exposure, the licensee or registrant shall determine:

1. The internal and external doses from all previous planned special exposures; and

2. All doses in excess of the limits, including doses received during accidents and emergencies, received during the lifetime of the individual.

C. In complying with the requirements of subsection A or B of this section, a licensee or registrant may:

1. Accept, as a record of the occupational dose that the individual received during the current year, a written signed statement from the individual, or from the individual's most recent employer for work involving radiation exposure, that discloses the nature and the amount of any occupational dose that the individual received during the current year;

2. Accept, as the record of lifetime cumulative radiation dose, an up-to-date occupational radiation exposure form provided by the agency or equivalent, signed by the individual and countersigned by an appropriate official of the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant; and

3. Obtain reports of the individual's dose equivalent from the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant, by telephone, telegram, facsimile, or letter. The licensee or registrant shall request a written verification of the dose data if the authenticity of the transmitted report cannot be established.

D. Do the following:

1. The licensee or registrant shall record the exposure history, as required by this section on an occupational radiation exposure form provided by the agency, or other clear and legible record, of all the information required on that form. The form or record shall show each period in which the individual received occupational exposure to radiation or radioactive material and shall be signed by the individual who received the exposure. For each period for which the licensee or registrant obtains reports, the licensee or registrant shall use the dose shown in the report in preparing the occupational radiation exposure form provided by the agency or equivalent. For any period in which the licensee or registrant does not obtain a report, the licensee or registrant shall place a notation on the occupational radiation exposure form provided by the agency or equivalent indicating the periods of time for which data are not available.

2. Licensees or registrants are not required to partition historical dose between external dose equivalent(s) and internal committed dose equivalent(s). Further, occupational exposure histories obtained and recorded on the occupational radiation exposure form provided by the agency or equivalent before September 20, 2006, might not have included effective dose equivalent, but may be used in the absence of specific information on the intake of radionuclides by the individual.

E. If the licensee or registrant is unable to obtain a complete record of an individual's current and previously accumulated occupational dose, the licensee or registrant shall assume:

1. In establishing administrative controls pursuant to 12VAC5-481-640 for the current year, that the allowable dose limit for the individual is reduced by 12.5 mSv (1.25 rem) for each quarter for which records were unavailable and the individual was engaged in activities that could have resulted in occupational radiation exposure; and

2. That the individual is not available for planned special exposures.

F. The licensee or registrant shall retain the records on an occupational radiation exposure form provided by the agency or equivalent until the agency terminates each pertinent license or registration requiring this record. The licensee or registrant shall retain records used in preparing the occupational radiation exposure form provided by the agency or equivalent for three years after the record is made.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-690 Planned special exposures

A licensee may authorize an adult worker to receive doses in addition to and accounted for separately from the doses received under the limits specified in 12VAC5-481-640 provided that each of the following conditions is satisfied:

1. The licensee authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the dose estimated to result from the planned special exposure are unavailable or impractical.

2. The licensee, and employer if the employer is not the licensee, specifically authorizes the planned special exposure in writing before the exposure occurs.

3. Before a planned special exposure, the licensee ensures that each individual involved is:

a. Informed of the purpose of the planned operation;

b. Informed of the estimated doses and associated potential risks and specific radiation levels or other conditions that might be involved in performing the task; and

c. Instructed in the measure to be taken to keep the dose ALARA considering other risks that may be present.

4. Prior to permitting an individual to participate in a planned special exposure, the licensee ascertains prior doses as required by 12VAC5-481-1020 during the lifetime of the individual for each individual involved.

5. Subject to 12VAC5-481-640 A 2, the licensee does not authorize a planned special exposure that would cause an individual to receive a dose from all planned special exposures and all doses in excess of the limits to exceed:

a. The numerical values of any of the dose limits in 12VAC5-481-640 A 1 in any year; and

b. Five times the annual dose limits in 12VAC5-481-640 A 1 during the individual's lifetime.

6. The licensee maintains records of the conduct of a planned special exposure in accordance with 12VAC5-481-1030 and submits a written report in accordance with 12VAC5-481-1120.

7. The licensee records the best estimate of the dose resulting from the planned special exposure in the individual's record and informs the individual in writing of the dose within 30 days from the date of the planned special exposure. The dose from planned special exposures is not be considered in controlling future occupational dose limits of the individual under 12VAC5-481-640 A 1 but is to be included in evaluations required by subdivisions 4 and 5 of this section.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-700 Occupational dose limits for minors

The annual occupational dose limits for minors are 10% of the annual dose limits specified for adult workers in 12VAC5-481-640.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-710 Dose to an embryo/fetus

A. The licensee shall ensure that the dose equivalent to the embryo/fetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 500 millirem (5 mSv).

B. The licensee shall make efforts to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limits in subsection A of this section.

C. The dose equivalent to the embryo/fetus is the sum of:

1. The deep dose equivalent to the declared pregnant woman; and

2. The dose equivalent to the embryo/fetus resulting from radionuclides in the embryo/fetus and radionuclides in the declared pregnant woman.

D. If the dose equivalent to the embryo/fetus is found to have exceeded 500 millirem (5 mSv), or is within 50 millirem (0.5 mSv) of this dose, by the time the woman declares the pregnancy to the licensee, the licensee shall be deemed to be in compliance with subsection A of this section if the additional dose equivalent to the embryo/fetus does not exceed 50 millirem (0.5 mSv) during the remainder of the pregnancy.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

Article 4 Radiation Dose Limits for Individual Members of the Public

12VAC5-481-720 Dose limits for individual members of the public

Article 4 Radiation Dose Limits for Individual Members of the Public

A. Each licensee shall conduct operations so that:

1. The total effective dose equivalent to individual members of the public from the licensed operation does not exceed 100 millirem (1 mSv) in a year exclusive of the dose contribution from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released under 12VAC5-481-1870, from voluntary participation in medical research programs, and from the licensee's disposal of radioactive material into sanitary sewerage in accordance with 12VAC5-481-930; and

2. The dose in any unrestricted area from external sources exclusive of the dose contribution from individuals administered radioactive material and released in accordance with 12VAC5-481-1870 does not exceed 2 millirem (0.02 millisievert) in any one hour.

B. If the licensee permits members of the public to have access to controlled areas, the limits for members of the public continue to apply to those individuals.

C. Notwithstanding subdivision A 1 of this section, a licensee may permit visitors to an individual who cannot be released under 12VAC5-481-1870 to receive a radiation dose greater than 100 millirem (1 mSv) if:

1. The radiation dose received does not exceed 500 millirem (5 mSv); and

2. The authorized user as defined in 12VAC5-481-10 has determined before the visit that it is appropriate.

D. A licensee or licensee applicant may apply for prior agency authorization to operate up to an annual dose limit for an individual member of the public of 500 millirem (5 mSv). The licensee or license applicant shall include the following information in this application:

1. Demonstration of the need for and the expected duration of operations in excess of the limit in subsection A of this section;

2. The licensee's program to assess and control dose within the 500 millirem (5 mSv) annual limit; and

3. The procedures to be followed to maintain the dose as low as is reasonably achievable.

E. In addition to these requirements, a licensee subject to the provisions of the U.S. Environmental Protection Agency's generally applicable environmental radiation standards in 40 CFR Part 190 shall comply with those standards.

F. The agency may impose additional restrictions on radiation levels in unrestricted areas and on the total quantity of radionuclides that a licensee may release in effluents in order to restrict the collective dose.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-730 Compliance with dose limits for individual members of the public

A. The licensee shall make or cause to be made, as appropriate, surveys of radiation levels in unrestricted and controlled areas and radioactive materials in effluents released to unrestricted and controlled areas to demonstrate compliance with the dose limits for individual members of the public in 12VAC5-481-720.

B. A licensee shall show compliance with the annual dose limits in 12VAC5-481-720 by:

1. Demonstrating by measurement or calculation that the total effective dose equivalent to the individual likely to receive the highest dose from the licensed operation does not exceed the annual dose limit; or

2. Demonstrating that:

a. The annual average concentrations of radioactive material released in gaseous and liquid effluents at the boundary of the unrestricted area do not exceed the values specified in Table 2 of Appendix B to 10 CFR Part 20; and

b. If an individual were continuously present in an unrestricted area, the dose from external sources would not exceed 2 millirem (0.02 mSv) in an hour and 50 millirem (0.5 mSv) in a year.

C. Upon approval from the agency, the licensee may adjust the effluent concentration values in Table 2 of Appendix B to 10 CFR Part 20, for members of the public, to take into account the actual physical and chemical characteristics of the effluents (e.g., aerosol size distribution, solubility, density, radioactive decay equilibrium, and chemical form).

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

Article 5 Testing for Leakage or Contamination of Sealed Sources

12VAC5-481-740 Testing for leakage or contamination of sealed sources

Article 5 Testing for Leakage or Contamination of Sealed Sources

A. The licensee or registrant in possession of any sealed source shall assure that:

1. Each sealed source, except as specified in subsection B of this section, is tested for leakage or contamination and the test results are received before the sealed source is put into use unless the licensee or registrant has a certificate from the transferor indicating that the sealed source was tested within six months before transfer to the licensee or registrant;

2. Each sealed source that is not designed to emit alpha particles is tested for leakage or contamination at intervals not to exceed six months or at alternative intervals approved by the agency, after evaluation of information specified by 12VAC5-481-480 J 4 and 5, the NRC or another agreement state;

3. Each sealed source that is designed to emit alpha particles is tested for leakage or contamination at intervals not to exceed three months or at alternative intervals approved by the agency, after evaluation of information specified by 12VAC5-481-480 J 4 and 5, the NRC or another agreement state;

4. For each sealed source that is required to be tested for leakage or contamination, at any other time there is reason to suspect that the sealed source might have been damaged or might be leaking, the licensee or registrant shall assure that the sealed source is tested for leakage or contamination before further use;

5. Tests for leakage for all sealed sources, except brachytherapy sources manufactured to contain radium, shall be capable of detecting the presence of 185 Bq (0.005 μCi) of radioactive material on a test sample. Test samples shall be taken from the sealed source or from the surfaces of the container in which the sealed source is stored or mounted on which one might expect contamination to accumulate. For a sealed source contained in a device, test samples are obtained when the source is in the "off" position;

6. The test for leakage for brachytherapy sources manufactured to contain radium shall be capable of detecting an absolute leakage rate of 37 Bq (0.001 μCi) of radon-222 in a 24-hour period when the collection efficiency for radon-222 and its daughters has been determined with respect to collection method, volume and time;

7. Tests for contamination from radium daughters shall be taken on the interior surface of brachytherapy source storage containers and shall be capable of detecting the presence of 185 Bq (0.005 μCi) of a radium daughter which has a half-life greater than four days.

B. A licensee or registrant need not perform test for leakage or contamination on the following sealed sources:

1. Sealed sources containing only radioactive material with a half-life of less than 30 days;

2. Sealed sources containing only radioactive material as a gas;

3. Sealed sources containing 3.7 MBq (100 μCi) or less of beta or photon-emitting material or 370 kBq (10 μCi) or less of alpha-emitting material;

4. Sealed sources containing only hydrogen-3;

5. Seeds of iridium-192 encased in nylon ribbon; and

6. Sealed sources that are stored, not being used and identified as in storage. The licensee or registrant shall, however, test each such sealed source for leakage or contamination and receive the test results at intervals not to exceed five years and within six months before the date of use or transfer.

C. Tests for leakage or contamination from sealed sources shall be performed by persons specifically authorized by the agency, the NRC or another agreement state to perform such services.

D. Test results shall be kept in units of becquerel or microcurie and maintained for inspection by the agency. Records of test results for sealed sources shall be made pursuant to 12VAC5-481-1010.

E. The following shall be considered evidence that a sealed source is leaking:

1. The presence of 185 Bq (0.005 μCi) or more of removable contamination on any test sample;

2. Leakage of 37 Bq (0.001 μCi) of radon-222 per 24 hours for brachytherapy sources manufactured to contain radium;

3. The presence of removable contamination resulting from the decay of 185 Bq (0.005 μCi) or more of radium.

F. The licensee or registrant shall immediately withdraw a leaking sealed source from use and shall take action to prevent the spread of contamination. The leaking sealed source shall be repaired or disposed of in accordance with this part.

G. Reports of test results for leaking or contaminated sealed sources shall be made pursuant to 12VAC5-481-1150.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 6 Surveys and Monitoring

12VAC5-481-750 General

Article 6 Surveys and Monitoring

A. Licensees shall make or cause to be made surveys of areas, including the subsurface, that:

1. Are necessary for the licensee to comply with this chapter; and

2. Are reasonable under the circumstances to evaluate:

a. The magnitude and extent of radiation levels;

b. The concentrations or quantities of radioactive material; and

c. The potential radiological hazards of the radiation levels and residual radioactivity detected.

B. Notwithstanding 12VAC5-481-1000 A, records from surveys describing the location and amount of subsurface residual radioactivity identified at the site shall be kept with records important for decommissioning, and such records shall be retained in accordance with 12VAC5-481-450 C 8.

C. Licensees shall ensure that the survey instruments used to show compliance with this chapter are calibrated before first use, annually (not to exceed 12 months), except when a more frequent interval is specified in another applicable part of this chapter or a license condition, and following a repair that affects the calibration. These calibrations shall include:

1. Use of a radiation source on all scales;

2. At energies appropriate for the use;

3. For linear scale instruments, at two points located approximately one-third and two-thirds of full-scale on each scale; for logarithmic scale instruments, at mid-range of each decade, and at two points of at least one decade; and for digital instruments, at three points between 2 and 1000 mrem (0.02 and 10 millisieverts) per hour;

4. For dose rate instruments, so that an accuracy within plus or minus 20% of the true radiation dose can be demonstrated at each point checked; and

5. Conspicuously note on the instrument the date of calibration.

D. Licensees may not use survey instruments if the difference between the indicated exposure rate and the calculated exposure rate is more than 20%.

E. All personnel dosimeters, except for direct and indirect reading pocket ionization chambers and those dosimeters used to measure the dose to the extremities, that require processing to determine the radiation dose and that are used by the licensee to comply with 12VAC5-481-640, with other applicable provisions of this chapter, or with conditions specified in a license shall be processed and evaluated by a dosimetry processor with the following:

1. Holding current personnel dosimetry accreditation from the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Institute of Standards and Technology; and

2. Approved in this accreditation process for the type of radiation or radiations included in the NVLAP program that most closely approximates the type of radiation or radiation for which the individual wearing the dosimeter is monitored.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-760 Conditions requiring individual monitoring of external and internal occupational dose

Each licensee shall monitor exposures from sources of radiation at levels sufficient to demonstrate compliance with the occupational dose limits of this part. At a minimum:

1. Each licensee shall monitor occupational exposure to radiation from licensed and unlicensed radiation sources under the control of the licensee and shall supply and require the use of individual monitoring devices by:

a. Adults likely to receive, in one year from sources external to the body, a dose in excess of 10% of the limits in 12VAC5-481-640 A;

b. Minors likely to receive, in one year from radiation sources external to the body, a deep dose equivalent in excess of 100 millirem (1 mSv), a lens dose equivalent in excess of 150 millirem (1.5 mSv), or a shallow dose equivalent to the skin or to the extremities in excess of 500 millirem (5 mSv);

c. Declared pregnant women likely to receive, during the entire pregnancy, from radiation sources external to the body, a deep dose equivalent in excess of 100 millirem (1 mSv); and

d. Individuals entering a high or very high radiation area.

2. Each licensee shall monitor (see 12VAC5-481-670) the occupational intake of radioactive material by and assess the committed effective dose equivalent to:

a. Adults likely to receive, in one year, an intake in excess of 10% of the applicable ALIs in Table 1, Columns 1 and 2, of Appendix B to 10 CFR Part 20;

b. Minors likely to receive, in one year, a committed effective dose equivalent in excess of 100 millirem (1 mSv); and

c. Declared pregnant women likely to receive, during the entire pregnancy, a committed effective dose equivalent in excess of 100 millirem (1 mSv).

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-770 Location of individual monitoring devices

Each licensee or registrant shall ensure that individuals who are required to monitor occupational doses in accordance with 12VAC5-481-760 wear individual monitoring devices as follows:

1. An individual monitoring device used for monitoring the dose to the whole body shall be worn at the unshielded location of the whole body likely to receive the highest exposure. When a protective apron is worn, the location of the individual monitoring device is typically at the neck (collar);

2. An individual monitoring device used for monitoring the dose to an embryo/fetus of a declared pregnant woman, pursuant to 12VAC5-481-710, shall be located at the waist under any protective apron being worn by the woman;

3. An individual monitoring device used for monitoring the eye dose equivalent, to demonstrate compliance with 12VAC5-481-640, shall be located at the neck (collar), outside any protective apron being worn by the monitored individual, or at an unshielded location closer to the eye;

4. An individual monitoring device used for monitoring the dose to the extremities, to demonstrate compliance with 12VAC5-481-640, shall be worn on the extremity likely to receive the highest exposure. Each individual monitoring device shall be oriented to measure the highest dose to the extremity being monitored.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

Article 7 Control of Exposure from External Sources in Restricted Areas

12VAC5-481-780 Control of access to high radiation areas

Article 7 Control of Exposure from External Sources in Restricted Areas

A. The licensee shall ensure that each entrance or access point to a high radiation area has one or more of the following features:

1. A control device that, upon entry into the area, causes the level of radiation to be reduced below that level at which an individual might receive a deep dose equivalent of 100 millirem (1 mSv) in 1 hour at 30 centimeters from the radiation source or from any surface that the radiation penetrates;

2. A control device that energizes a conspicuous visible or audible alarm signal so that the individual entering the high radiation area and the supervisor of the activity are made aware of entry; or

3. Entryways that are locked, except during periods when access to the areas is required, with positive control over each individual entry.

B. In place of the controls required by subsection A of this section for a high radiation area, the licensee may substitute continuous direct or electronic surveillance that is capable of preventing unauthorized entry.

C. A licensee may apply to the agency for approval of alternative methods for controlling access to high radiation areas.

D. The licensee shall establish the controls required by subsections A and C of this section in a way that does not prevent individuals from leaving a high radiation area.

E. Control is not required for each entrance or access point to a room or other area that is a high radiation area solely because of the presence of radioactive materials prepared for transport and packaged and labeled in accordance with regulations of the U.S. Department of Transportation provided that:

1. The packages do not remain in the area longer than three days; and

2. The dose rate at one meter from the external surface of any package does not exceed 10 millirem (0.1 mSv) per hour.

F. Control of entrance or access to rooms or other areas in hospitals is not required solely because of the presence of patients containing radioactive material, provided that there are personnel in attendance who will take the necessary precautions to prevent the exposure of individuals to radiation or radioactive material in excess of the limits established in this part and to operate within the ALARA provisions of the licensee's radiation protection program.

G. The licensee or registrant is not required to control entrance or access to rooms or other areas containing sources of radiation capable of producing a high radiation area as described in this section if the licensee or registrant has met all the specific requirements for access and control specified in other applicable parts of this chapter, such as Part V (12VAC5-481-1170 et seq.) for industrial radiography, Part VI (12VAC5-481-1580 et seq.) for X-rays in the healing arts, Part IX (12VAC5-481-2140 et seq.) for particle accelerators, and Part XII (12VAC5-481-2660 et seq.) for irradiators.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-790 Control of access to very high radiation areas

A. In addition to the requirements in 12VAC5-481-780, the licensee or registrant shall institute measures to ensure that an individual is not able to gain unauthorized or inadvertent access to areas in which radiation levels could be encountered at 5 Gy (500 rad) or more in one hour at one meter from a source of radiation or any surface through which the radiation penetrates. This requirement does not apply to rooms or areas in which diagnostic X-ray systems are the only source of radiation, or to nonself-shielded irradiators.

B. The licensee or registrant is not required to control entrance or access to rooms or other areas containing sources of radiation capable of producing a very high radiation area as described in subsection A of this section if the registrant has met all the specific requirements for access and control specified in other applicable parts of these regulations, such as Part V (12VAC5-481-1170 et seq.) for industrial radiography, Part VI (12VAC5-481-1580 et seq.) for X-rays in the healing arts, Part IX (12VAC5-481-2140 et seq.) for particle accelerators, and Part XII (12VAC5-481-2660 et seq.) for irradiators.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-800 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; repealed, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 8 Respiratory Protection and Controls to Restrict Internal Exposure in Restricted Areas

12VAC5-481-810 Use of process or other engineering controls

Article 8 Respiratory Protection and Controls to Restrict Internal Exposure in Restricted Areas

The licensee shall use, to the extent practical, process or other engineering controls (e.g., containment, decontamination, or ventilation) to control the concentration of radioactive material in air.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-820 Use of other controls

A. When it is not practical to apply process or other engineering controls to control the concentrations of radioactive material in the air to values below those that define an airborne radioactivity area, the licensee shall, consistent with maintaining the total effective dose equivalent ALARA, increase monitoring and limit intakes by one or more of the following means:

1. Control of access;

2. Limitation of exposure times;

3. Use of respiratory protection equipment; or

4. Other controls.

B. If the licensee performs an ALARA analysis to determine whether or not respirators should be used, the licensee may consider safety factors other than radiological factors. The licensee should also consider the impact of respirator use on the industrial health and safety of workers.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-830 Use of individual respiratory protection equipment

A. If the licensee assigns or permits the use of respiratory protection equipment to limit the intake of radioactive material:

1. The licensee shall use only respiratory protection equipment that is tested and certified by the National Institute for Occupational Safety and Health (NIOSH) except as otherwise noted in this part.

2. If the licensee wishes to use equipment that has not been tested or certified by NIOSH, or for which there is no schedule for testing or certification, the licensee shall submit an application to the agency for authorized use of this equipment except as provided in this part. The application shall include evidence that the material and performance characteristics of the equipment are capable of providing the proposed degree of protection under anticipated conditions of use. This shall be demonstrated either by licensee testing or on the basis of reliable test information.

3. The licensee shall implement and maintain a respiratory protection program that includes:

a. Air sampling sufficient to identify the potential hazard, permit proper equipment selection, and estimate doses;

b. Surveys and bioassays, as necessary, to evaluate actual intakes;

c. Testing of respirators for operability (i.e., user seal check for face sealing devices and functional check for others) immediately prior to each use;

d. Written procedures regarding:

(1) Monitoring, including air sampling and bioassays;

(2) Supervision and training of respirator users;

(3) Fit testing;

(4) Respirator selection;

(5) Breathing air quality;

(6) Inventory and control;

(7) Storage, issuance, maintenance, repair, testing, and quality assurance of respiratory protection equipment;

(8) Recordkeeping; and

(9) Limitations on periods of respirator use and relief from respirator use;

e. Determination by a physician that the individual user is medically fit to use respiratory protection equipment at the following stages:

(1) Before the initial fitting of a face sealing respirator;

(2) Before the first field use of non-face sealing respirators, and

(3) Either every 12 months thereafter, or periodically at a frequency determined by a physician; and

f. Fit testing, with fit factor greater than 10 times the assigned protection factor (APF) for negative pressure devices, and a fit factor greater than 500 for any positive pressure, continuous flow, and pressure-demand devices, before the first field use of tight fitting, face-sealing respirators and periodically thereafter at a frequency not to exceed one year. Fit testing shall be performed with the facepiece operating in the negative pressure mode.

4. The licensee shall advise each respirator user that the user may leave the area at any time for relief from respirator use in the event of equipment malfunction, physical or psychological distress, procedural or communication failure, significant deterioration of operating conditions, or any other conditions that might require such relief.

5. The licensee shall also consider limitations appropriate to the type and mode of use. When selecting respiratory devices the licensee shall provide for vision correction, adequate communication, low temperature work environments, and the concurrent use of other safety or radiological protection equipment. The licensee shall use equipment in such a way as not to interfere with the proper operation of the respirator.

6. Standby rescue persons are required whenever one-piece atmosphere-supplying suits, or any combination of supplied air respiratory protection device and personnel protective equipment, are used from which an unaided individual would have difficulty extricating himself. The standby persons shall be equipped with respiratory protection devices or other apparatus appropriate for the potential hazards. The standby rescue persons shall observe or otherwise maintain continuous communication with the workers (e.g., visual, voice, signal line, telephone, radio, or other suitable means), and be immediately available to assist them in case of a failure of the air supply or for any other reason that requires relief from distress. A sufficient number of standby rescue persons shall be immediately available to assist all users of this type of equipment and to provide effective emergency rescue if needed.

7. Atmosphere-supplying respirators shall be supplied with respirable air of grade D quality or better as defined by the Compressed Gas Association in publication G-7.1, "Commodity Specification for Air," 1997, and included in the regulations of the Occupational Safety and Health Administration (29 CFR 1910.134(i)(1)(ii)(A) through (E). Grade D quality air criteria include:

a. Oxygen content (v/v) of 19.5-23.5%;

b. Hydrocarbon (condensed) content of 5 milligrams per cubic meter of air or less;

c. Carbon monoxide (CO) content of 10 ppm or less;

d. Carbon dioxide content of 1,000 ppm or less; and

e. Lack of noticeable odor.

8. The licensee shall ensure that no objects, materials or substances, such as facial hair, or any conditions that interfere with the face (facepiece seal or valve function) and that are under the control of the respirator wearer, are present between the skin of the wearer's face and the sealing surface of a tight-fitting respirator facepiece.

9. In estimating the dose to individuals from intake of airborne radioactive materials, the concentration of radioactive material in the air that is inhaled when respirators are worn is initially assumed to be the ambient concentration in air without respiratory protection, divided by the assigned protection factor. If the dose is later found to be greater than the estimated dose, the corrected value shall be used. If the dose is later found to be less than the estimated dose, the corrected value may be used.

B. The agency may impose restrictions in addition to the provisions of this section, 12VAC5-481-820, and 12VAC5-481-3680 in order to:

1. Ensure that the respiratory protection program of the licensee is adequate to limit doses to individuals from intakes of airborne radioactive materials consistent with maintaining total effective dose equivalent ALARA; and

2. Limit the extent to which a licensee may use respiratory protection equipment instead of process or other engineering controls.

C. The licensee shall obtain authorization from the agency before using assigned protection factors in excess of those specified in 12VAC5-481-3680. The agency may authorize a licensee to use higher assigned protection factors on receipt of an application that:

1. Describes the situation for which a need exists for higher protection factors; and

2. Demonstrates that the respiratory protection equipment provides these higher protection factors under the proposed conditions of use.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

Article 9 Security and Control of Licensed or Registered Sources of Radiation

12VAC5-481-840 Security and control of licensed or registered sources of radiation

Article 9 Security and Control of Licensed or Registered Sources of Radiation

A. The licensee shall:

1. Secure radioactive material from unauthorized removal or access when stored in controlled or unrestricted areas.

2. Control and maintain constant surveillance and use devices or administrative procedures to prevent unauthorized use of radioactive material that is in a controlled or unrestricted area and that is not in storage.

B. The registrant shall secure registered radiation machines from unauthorized removal.

C. The registrant shall use devices or administrative procedures to prevent unauthorized use of registered radiation machines.

D. Each portable gauge licensee shall use a minimum of two independent physical controls that form tangible barriers to secure portable gauges from unauthorized removal, whenever portable gauges are not under the control and constant surveillance of the licensee.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

Article 10 Precautionary Procedures

12VAC5-481-850 Radiation symbol; caution signs

Article 10 Precautionary Procedures

A. Unless otherwise authorized by the agency, the symbol prescribed by this section shall use the colors magenta, purple, or black on a yellow background. The symbol prescribed by this section is the three-bladed design:

1. The cross-hatched area is to be magenta, purple, or black, and

2. The background is to be yellow.

B. Exception to color requirements for standard radiation symbol.Notwithstanding the requirements of subsection A of this section, licensees are authorized to label sources, source holders, or device components containing sources of radiation that are subjected to high temperatures with conspicuously etched or stamped radiation caution symbols and without a color requirement.

C. Additional information on signs and labels. In addition to the contents of signs and labels prescribed in this section, the licensee may provide on or near the required signs and labels, additional information, as appropriate, to make individuals aware of potential radiation exposures and to minimize the exposures.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-860 Posting requirements

A. Licensees shall post each radiation area with a conspicuous sign or signs bearing the radiation symbol as described in 12VAC5-481-850 and the words "CAUTION, RADIATION AREA."

B. Licensees shall post each high radiation area with a conspicuous sign or signs bearing the radiation symbol as described in 12VAC5-481-850 and the words "CAUTION, HIGH RADIATION AREA" or "DANGER, HIGH RADIATION AREA."

C. Licensees shall post each very high radiation area with a conspicuous sign or signs bearing the radiation symbol as described in 12VAC5-481-850 and the words "GRAVE DANGER, VERY HIGH RADIATION AREA."

D. Licensees shall post each airborne radioactivity area with a conspicuous sign or signs bearing the radiation symbol as described in 12VAC5-481-850 and the words, "CAUTION, AIRBORNE RADIOACTIVITY AREA," or "DANGER, AIRBORNE RADIOACTIVITY AREA."

E. The licensee shall post each area or room in which there is used or stored an amount of licensed material exceeding 10 times the quantity of such material specified in 12VAC5-481-3700 with a conspicuous sign or signs bearing the radiation symbol as described in 12VAC5-481-850 and the words "CAUTION, RADIOACTIVE MATERIALS" or "DANGER, RADIOACTIVE MATERIALS."

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-870 Exceptions to posting requirements

A. Licensees are not required to post caution signs in areas or rooms containing radioactive materials for periods of less than eight hours, if the following conditions are met:

1. The materials are constantly attended during these periods by an individual who takes the precautions necessary to prevent the exposure of individuals to radiation or radioactive materials in excess of the limits established in this part; and

2. The area or room is subject to the licensee's control.

B. Rooms or other areas in hospitals that are occupied by patients are not required to be posted with caution signs pursuant to 12VAC5-481-860, provided that the patient could be released from licensee control pursuant to 12VAC5-481-1870.

C. A room or area is not required to be posted with a caution sign because of the presence of a sealed source, provided that the radiation level at 30 centimeters from the surface of the sealed source container or housing does not exceed 5 millirem (0.05 mSv) per hour.

D. Rooms in hospitals or clinics that are used for teletherapy are exempt from the requirement to post caution signs under 12VAC5-481-860 if

1. Access to the room is controlled pursuant to 12VAC5-481-2043; and

2. Personnel in attendance take necessary precautions to prevent the inadvertent exposure of workers, other patients, and members of the public to radiation in excess of the limits established in this part.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-880 Labeling containers and radiation machines

A. Licensees shall ensure that each container of licensed material bears a durable, clearly visible label bearing the radiation symbol as described in 12VAC5-481-850 and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL." The label shall also provide sufficient information, such as the radionuclides present, an estimate of the quantity of radioactivity, the date for which the activity is estimated, radiation levels, kinds of materials, and mass enrichment, to permit individuals handling or using the containers or working in the vicinity of the containers to take precautions to avoid or minimize exposures.

B. Each registrant shall ensure that each radiation machine is labeled in a conspicuous manner that cautions individuals that radiation is produced when it is energized.

C. Licensees shall, prior to removal or disposal of empty uncontaminated containers to unrestricted areas, remove or deface the radioactive material label or otherwise clearly indicate that the container no longer contains radioactive materials.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-890 Exemptions to labeling requirements

Licensees are not required to label:

1. Containers holding licensed material in quantities less than the quantities listed in 12VAC5-481-3700;

2. Containers holding licensed material in concentrations less than those specified in Appendix B to 10 CFR Part 20;

3. Containers attended by an individual who takes the precautions necessary to prevent the exposure of individuals in excess of the limits established by this part;

4. Containers when they are in transport and packaged and labeled in accordance with regulations of the U.S. Department of Transportation;

5. Containers that are accessible only to individuals authorized to handle or use them, or to work in the vicinity of the containers, if the contents are identified to these individuals by readily available written record (e.g., containers in locations such as water filled canals, storage vaults, or hot cells). The record shall be retained as long as the containers are in use for the purpose indicated on the record; or

6. Installed manufacturing or process equipment, such as reactor components, piping, and tanks.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-900 Procedures for receiving and opening packages

A. Licensees who expect to receive a package containing quantities of radioactive material in excess of a Type A quantity, as defined in 12VAC5-481-10 and 12VAC5-481-3770, shall make arrangements to receive:

1. The package when the carrier offers it for delivery; or

2. Notification of the arrival of the package at the carrier's terminal and to take possession of the package expeditiously.

B. Licensees shall monitor the following:

1.The external surfaces of a labeled package for radioactive contamination unless the package contains only radioactive material in the form of a gas or in special form as defined in 12VAC5-481-10;

2. The external surfaces of a labeled package for radiation levels unless the package contains quantities of radioactive material that are less than or equal to the Type A quantity, as defined in 12VAC5-481-10 and 12VAC5-481-3770; and

3. All packages known to contain radioactive material for radioactive contamination and radiation levels if there is evidence of degradation of package integrity, such as packages that are crushed, wet, or damaged.

C. Licensees shall perform the monitoring required by subsection B of this section as soon as practical after receipt of the package, but not later than three hours after the package is received at the licensee's facility if it is received during the licensee's normal working hours, if there is evidence of degradation of package integrity (e.g., packages that are crushed, wet, or damaged), or if it is received after working hours, not later than three hours from the beginning of the next working day.

D. Licensees shall immediately notify the final delivery carrier and the agency by telephone, when:

1. Removable contamination exceeds the limits of subdivision 9 of 12VAC5-481-3080; or

2. External radiation levels exceed the limits of subdivision 10 of 12VAC5-481-3080.

E. Licensees shall:

1. Establish, maintain, and retain written procedures for safely opening packages in which radioactive material is received; and

2. Ensure that the procedures are followed and that due consideration is given to special instructions for the type of package being opened.

F. Licensees transferring special form sources in licensee-owned or licensee-operated vehicles to and from a work site are exempt from the contamination monitoring requirements of subsection B of this section, but are not exempt from the survey requirements in subsection B of this section for measuring radiation levels that are required to ensure that the source is still properly lodged in its shield.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

Article 11 Waste Disposal

12VAC5-481-910 General requirements

Article 11 Waste Disposal

A. Licensees shall dispose of licensed material only in the following ways:

1. By transfer to an authorized recipient as provided in 12VAC5-481-570;

2. By decay in storage;

3. By release in effluents within the limits of 12VAC5-481-720; or

4. As authorized under 12VAC5-481-920, 12VAC5-481-930, 12VAC5-481-940, 12VAC5-481-950, or 12VAC5-481-971.

B. A person shall be specifically licensed to receive waste containing licensed material from other persons for the following actions:

1. Treatment prior to disposal;

2. Treatment or disposal by incineration;

3. Decay in storage;

4. Disposal at a land disposal facility licensed under Part XI (12VAC5-481-2330 et seq.) of this chapter; or

5. Disposal at a geologic repository under 10 CFR Part 60 or 10 CFR Part 63.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-920 Method for obtaining approval of proposed disposal procedures

A licensee or registrant or applicant for a license or registration may apply to the agency for approval of proposed procedures, not otherwise authorized in these regulations, to dispose of licensed or registered material generated in the licensee's or registrant's operations. Each application shall include:

1. A description of the waste containing licensed or registered material to be disposed of, including the physical and chemical properties that have an impact on risk evaluation, and the proposed manner and conditions of waste disposal;

2. An analysis and evaluation of pertinent information on the nature of the environment;

3. The nature and location of other potentially affected facilities; and

4. Analyses and procedures to ensure that doses are maintained ALARA and within the dose limits in Part IV (12VAC5-481-600 et seq.) of this chapter.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-930 Disposal by release into sanitary sewerage

A. Licensees may discharge licensed material into sanitary sewerage if each of the following conditions is satisfied:

1. The licensed or other radioactive material is readily soluble or is readily dispersible biological material in water;

2. The quantity of licensed or other radioactive material that the licensee releases into the sewer in one month divided by the average monthly volume of water released into the sewer by the licensee does not exceed the concentration listed in Table 3 of Appendix B to 10 CFR Part 20;

3. If more than one radionuclide is released, the following conditions shall also be satisfied:

a. The licensee shall determine the fraction of the limit in Table 3 of Appendix B to 10 CFR Part 20 represented by discharges into sanitary sewerage by dividing the actual monthly average concentration of each radionuclide released by the licensee into the sewer by the concentration of that radionuclide listed in Table 3 of Appendix B to 10 CFR Part 20; and

b. The sum of the fractions for each radionuclide required by subdivision 3 a of this subsection does not exceed unity; and

4. The total quantity of licensed and other radioactive material that the licensee releases into the sanitary sewerage system in one year does not exceed 5 curies (185 GBq) of hydrogen-3, 1 curie (37 GBq) of carbon-14, and 1 curie (37 GBq) of all other radioactive materials combined.

B. Excreta from individuals undergoing medical diagnosis or therapy with radioactive material are not subject to the limitations contained in this section.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-940 Treatment or disposal by incineration

Licensees may treat or dispose of licensed material by incineration only if the material is in a form or concentration specified in 12VAC5-481-950, or as specifically approved by the agency pursuant to 12VAC5-481-920.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-950 Disposal of specific wastes

A. Licensees may dispose of the following licensed material as if it were not radioactive:

1. 0.05 μCi (1.85 kBq) or less of hydrogen-3 or carbon-14 per gram of medium used for liquid scintillation counting; and

2. 0.05 μCi (1.85 kBq) or less of hydrogen-3 or carbon-14 per gram of animal tissue, averaged over the weight of the entire animal.

B. Licensees may not dispose of tissue under subdivision A 2 of this section in a manner that would permit its use either as food for humans or as animal feed.

C. Licensees shall maintain records in accordance with 12VAC5-481-1060.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-960 Transfer for disposal and manifests

A. The requirements of this section and 12VAC5-481-3710 are designed to accomplish the following:

1. Control transfers of low level radioactive waste by any waste generator, waste collector, or waste processor licensee that ships low level waste either directly or indirectly through a waste collector or waste processor to a licensed low level waste land disposal facility (as defined in 12VAC5-481-10);

2. Establish a manifest tracking system; and

3. Supplement existing requirements concerning transfers and recordkeeping for those wastes.

B. Licensees shipping radioactive waste intended for ultimate disposal at a licensed land disposal facility shall document the information required and transfer this recorded information to the intended consignee in accordance with 12VAC5-481-3710.

C. Each shipment manifest shall include a certification by the waste generator as specified in 12VAC5-481-3710 G.

D. Each person involved in the transfer for disposal and disposal of waste, including the waste generator, waste collector, waste processor, and disposal facility operator, shall comply with the requirements specified in 12VAC5-481-3710 H.

E. Licensees shipping radioactive material as defined in subdivisions 3 and 4 under the definition of "byproduct material" in 12VAC5-481-10 intended for ultimate disposal at a land disposal facility licensed under Part XI (12VAC5-481-2330 et seq.) of this chapter, 10 CFR Part 61, or equivalent agreement state regulations shall document the information required on a manifest and transfer this recorded manifest information to the intended consignee in accordance with 12VAC5-481-3710.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-970 Compliance with environmental and health protection regulations

Nothing in this part relieves the licensee from complying with other applicable federal, state, and local regulations governing any other toxic or hazardous properties of materials that may be disposed of under this part.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-971 Disposal of certain radioactive material

A. Licensed material meeting the definition in subdivisions 3 and 4 of the definition of "byproduct material" in 12VAC5-481-10 may be disposed of in accordance with Part XI (12VAC5-481-2330 et seq.) of this chapter, even though it is not defined as low level radioactive waste. Therefore, any licensed byproduct material being disposed of at a facility or transferred for ultimate disposal at a facility licensed under Part XI (12VAC5-481-2330 et seq.) of this chapter, 10 CFR Part 61, or equivalent agreement state regulations shall meet the requirements of 12VAC5-481-960.

B. A licensee may dispose of byproduct material, as defined in subsection A of this section, at a disposal facility authorized to dispose of such material in accordance with any federal or state solid or hazardous waste law, including the Solid Waste Disposal Act (42 USC § 6901 et seq.).

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008; amended, Virginia Register Volume 32, Issue 24, eff. August 25, 2016.

Article 12 Records

12VAC5-481-980 General provisions

Article 12 Records

A. Licensees shall (i) use the units curie, rad, rem, and roentgen, including multiples and subdivisions, and may include the International System of Units (SI) units (Becquerel, gray, sievert, and coulomb per kilogram) and (ii) clearly indicate the units of all quantities on records required by this part.

B. Notwithstanding the requirements of subsection A of this section, when recording information on shipment manifests as required in 12VAC5-481-960 B, information shall be recorded in SI units or in SI units and units as specified in subsection A of this section.

C. The licensee shall make a clear distinction among the quantities entered on the records required by this part (e.g., total effective dose equivalent, shallow dose equivalent, lens dose equivalent, deep dose equivalent, and committed dose equivalent).

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-990 Records of radiation protection programs

A. Licensees shall maintain records of the radiation protection program, including:

1. The provisions of the program; and

2. Audits and other reviews of program content and implementation.

B. Licensees shall retain the records required by subdivision A 1 of this section until the agency terminates each pertinent license requiring the record. Licensees shall retain the records required by subdivision A 2 of this section for three years after the record is made.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-1000 Records of surveys

A. Licensees shall maintain records showing the results of surveys and calibrations required by 12VAC5-481-750 and 12VAC5-481-900 B. Licensees shall retain these records for three years after the record is made.

B. Licensees shall retain each of the following records until the agency terminates each pertinent license condition requiring the record:

1. Records of the results of surveys to determine the dose from external sources and used in the absence of or in combination with individual monitoring data in the assessment of individual dose equivalents;

2. Records of the results of measurements and calculations used to determine individual intakes of radioactive material and used in the assessment of internal dose;

3. Records showing the results of air sampling, surveys, and bioassays required pursuant to 12VAC5-481-830 A 3; and

4. Records of the results of measurements and calculations used to evaluate the release of radioactive effluents to the environment.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-1010 Records of tests for leakage or contamination of sealed sources

Records of tests for leakage or contamination of sealed sources (required by 12VAC5-481-740) shall be kept in units of becquerel or microcurie and maintained for five years after the records are made.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1020 Records of prior occupational dose

The licensee or registrant shall retain the records of prior occupational dose and exposure history as specified in 12VAC5-481-680 on an occupational radiation exposure form provided by the agency or equivalent until the agency terminates each pertinent license or registration requiring this record. The licensee or registrant shall retain records used in preparing an occupational radiation exposure form provided by the agency or equivalent for three years after the record is made.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1030 Records of planned special exposures

A. For each use of the provisions of 12VAC5-481-690 for planned special exposures, licensees shall maintain records that describe the following:

1. The exceptional circumstances requiring the use of a planned special exposure;

2. The name of the management official who authorized the planned special exposure and a copy of the signed authorization;

3. What actions were necessary;

4. Why the actions were necessary;

5. How doses were maintained ALARA; and

6. What individual and collective doses results were expected and the doses actually received in the planned special exposure.

B. Licensees shall retain the records until the agency terminates each pertinent license requiring these records.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-1040 Records of individual monitoring results

A. Licensees shall maintain records of doses received by all individuals for whom monitoring is required pursuant to 12VAC5-481-760 and records of doses received during planned special exposures, accidents, and emergency conditions. These records shall include, when applicable:

1. The deep dose equivalent to the whole body, lens deep dose equivalent, shallow dose equivalent to the skin, and shallow dose equivalent to the extremities;

2. The estimated intake of radionuclides (see 12VAC5-481-650);

3. The committed effective dose equivalent assigned to the intake of radionuclides;

4. The specific information used to assess the committed effective dose equivalent pursuant to 12VAC5-481-670 A and C and when required by 12VAC5-481-760;

5. The total effective dose equivalent when required by 12VAC5-481-650; and

6. The total of the deep dose equivalent and the committed dose to the organ receiving the highest total dose.

B. Licensees shall make entries of the records specified in subsection A of this section at least annually.

C. Licensees shall maintain the records specified in subsection A of this section in clear and legible records containing all the information required by 12VAC5-481-2280.

D. The records required under this section should be protected from public disclosure because of the personal privacy nature of the records. These records are protected by privacy laws, including when the records are transferred to the agency.

E. Licensees shall maintain the records of dose to an embryo/fetus with the records of dose to the declared pregnant woman. The declaration of pregnancy, including the estimated date of conception, shall also be kept on file, but may be maintained separately from the dose records.

F. Licensees shall retain the required form or record until the agency terminates each pertinent license requiring this record.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-1050 Records of dose to individual members of the public

A. Each licensee or registrant shall maintain records sufficient to demonstrate compliance with the dose limit for individual members of the public per 12VAC5-481-720.

B. The licensee or registrant shall retain the records required by subsection A of this section until the agency terminates each pertinent license or registration requiring the record.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1060 Records of waste disposal

A. Each licensee or registrant shall maintain records of the disposal of licensed or registered materials made pursuant to 12VAC5-481-920 through 12VAC5-481-950, Part XI (12VAC5-481-2330 et seq.) of this chapter, and disposal by burial in soil, including burials authorized before, September 1, 1980, of the rule that removed the authorization.

B. The licensee or registrant shall retain the records required by subsection A of this section until the agency terminates each pertinent license or registration requiring the record.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-1070 Records of testing entry control devices for very high radiation areas

A. Each licensee or registrant shall maintain records of tests made on entry control devices for very high radiation areas. These records must include the date, time, and results of each such test of function.

B. The licensee or registrant shall retain the records required by subsection A of this section for three years after the record is made.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1080 Form of records

Each record required by Part IV (12VAC5-481-600 et seq.) of this chapter shall be legible throughout the specified retention period. The record shall be the original or a reproduced copy or a microform, provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period or the record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records, such as letters, drawings, and specifications, shall include all pertinent information, such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

Article 13 Reports

12VAC5-481-1090 Reports of stolen, lost, or missing licensed or registered sources of radiation

Article 13 Reports

A. Each licensee or registrant shall report to the agency by telephone as follows:

1. Immediately after its occurrence becomes known to the licensee, stolen, lost, or missing licensed or registered radioactive material in an aggregate quantity equal to or greater than 1,000 times the quantity specified in 12VAC5-481-3700;

2. Within 30 days after its occurrence becomes known to the licensee, lost, stolen, or missing licensed or registered radioactive material in an aggregate quantity greater than 10 times the quantity specified in 12VAC5-481-3700 that is still missing; or

3. Immediately after its occurrence becomes known to the registrant, a stolen, lost, or missing radiation machine.

B. Each licensee or registrant required to make a report pursuant to subsection A of this section shall, within 30 days after making the telephone report, make a written report to the agency setting forth the following information:

1. A description of the licensed or registered source of radiation involved, including, for radioactive material, the kind, quantity, and chemical and physical form; and, for radiation machines, the manufacturer, model and serial number, type and maximum energy of radiation emitted;

2. A description of the circumstances under which the loss or theft occurred;

3. A statement of disposition, or probable disposition, of the licensed or registered source of radiation involved;

4. Exposures of individuals to radiation, circumstances under which the exposures occurred, and the possible total effective dose equivalent to persons in unrestricted areas;

5. Actions that have been taken, or will be taken, to recover the source of radiation; and

6. Procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of licensed or registered sources of radiation.

C. Subsequent to filing the written report, the licensee or registrant shall also report additional substantive information on the loss or theft within 30 days after the licensee or registrant learns of such information.

D. The licensee or registrant shall prepare any report filed with the agency pursuant to this section so that names of individuals who may have received exposure to radiation are stated in a separate and detachable portion of the report.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-1100 Notification of incidents

A. Notwithstanding any other requirements for notification, licensees shall immediately report each event involving radioactive material possessed by the licensee that may have caused or threatens to cause any of the following conditions:

1. An individual to receive:

a. A total effective dose equivalent of 25 rem (0.25 Sv) or more;

b. A lens dose equivalent of 75 rem (0.75 Sv) or more; or

c. A shallow dose equivalent to the skin or extremities or a total organ dose equivalent of 250 rad (2.5 Gy) or more; and

2. The release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for 24 hours, the individual could have received an intake five times the occupational annual limits on intake. The provision of this subdivision does not apply to locations where personnel are not normally stationed during routine operations, such as hot cells or process enclosures.

B. Licensees shall, within 24 hours of discovery of the event, report any event involving loss of control of a licensed material possessed by the licensee that may have caused, or threatened to cause, any of the following conditions:

1. An individual to receive, in a period of 24 hours:

a. A total effective dose equivalent exceeding 5 rem (0.05 Sv);

b. A lens dose equivalent exceeding 15 rem (0.15 Sv); or

c. A shallow dose equivalent to the skin or extremities or a total organ dose equivalent exceeding 50 rem (0.5 Sv); and

2. The release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for 24 hours, the individual could have received an intake in excess of one occupational annual limits on intake. The provisions of this subdivision do not apply to locations where personnel are not normally stationed during routine operations, such as hot cells or process enclosures.

C. Licensees shall prepare any report filed with the agency pursuant to this section so that names of individuals who received exposure to radiation or radioactive material are stated in a separate and detachable part of the report.

D. Reports made by licensees in response to the requirements of this section shall be made, via telephone, to the agency at (804) 864-8150 during normal business hours and to the State Emergency Operations Center at (804) 674-2400 after normal business hours.

E. The provisions of this section do not include doses that result from planned special exposures, provided that such doses are within the limits for planned special exposures, and are reported under 12VAC5-481-1120.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016; Errata, 39:5 VA.R. 943 October 24, 2022.

12VAC5-481-1110 Reporting requirements

A. Licensees shall notify the agency as soon as possible but not later than four hours after the discovery of an event that prevents immediate protective actions necessary to avoid exposures to radiation or radioactive materials that could exceed regulatory limits or releases of licensed material that could exceed regulatory limits (events may include fires, explosions, toxic gas releases, etc.). Licensees shall:

1. If required by this subsection and subsection B, notify the agency of any event, via telephone, during normal business hours to (804) 864-8150 or after hours to the State Emergency Operations Center at (804) 674-2400.

2. Submit a written report, either by mail or by hand delivery to the agency at 109 Governor Street, 7th Floor, Richmond, VA 23219.

B. Licensees shall notify the agency within 24 hours after the discovery of any of the following events involving licensed material:

1. An unplanned contamination event that:

a. Requires access to the contaminated area by workers or the public to be restricted for more than 24 hours by imposing additional radiological controls or by prohibiting entry into the area;

b. Involves a quantity of material greater than five times the lowest annual limit on intake specified in Appendix B to 10 CFR Part 20; and

c. Has access to the area restricted for a reason other than to allow isotopes with a half-life of less than 24 hours to decay prior to decontamination.

2. An event in which equipment is disabled or fails to function as designed when:

a. The equipment is required by regulation or license condition to prevent releases exceeding regulatory limits, to prevent exposures to radiation and radioactive materials exceeding regulatory limits, or to mitigate the consequences of an accident;

b. The equipment is required to be available and operable when it is disabled or fails to function; and

c. No redundant equipment is available and operable to perform the required safety function.

3. An event that requires unplanned medical treatment at a medical facility of an individual with spreadable radioactive contamination on the individual's clothing or body.

4. An unplanned fire or explosion damaging any licensed material or any device, container, or equipment containing licensed material when:

a. The quantity of material involved is greater than five times the lowest annual limit on intake specified in Appendix B to 10 CFR Part 20; and

b. The damage affects the integrity of the licensed material or its container.

C. Notifications of any event made by licensees in response to the requirements of subsections A and B of this section shall be made to the agency, via telephone, during normal business hours to (804) 864-8150 or after hours to the State Emergency Operations Center at (804) 674-2400 and provide the following:

1. To the extent that the information is available at the time of the notification, provide a name and call back telephone number;

2. A description of the event, including date and time; if known, the sequence of occurrences leading to the event including degradation or failure of structures, systems, equipment, components; and activities of personnel relied on to prevent potential accidents;

3. The exact location of the event and whether the remaining structures, systems, equipment, components, and activities of personnel relied on to mitigate the consequences are available and reliable to perform their function;

4. Radiological or chemical hazards involved including the isotopes, quantities, and chemical and physical form of the licensed material;

5. Actual or potential health and safety consequences to the workers, the public, and the environment, including relevant chemical and any radiation data for actual personnel exposures to radiation or radioactive materials or hazardous chemicals produced from licensed material;

6. External conditions affecting the event;

7. Status of the event including actions taken by the licensee in response to the event and the current and planned site status;

8. Notification, related to the event, that were made or are planned to be made to any other local, state, or federal agencies; and

9. Status of any press releases related to the event that were made or are planned.

10. Each licensee that makes a report required by subsection A or B of this section shall submit a written follow-up report within 30 days of the initial report. Written reports prepared pursuant to other regulations may be submitted to fulfill this requirement if the report contains all necessary information and the appropriate distribution is made. These written reports must be sent to the agency at 109 Governor Street, 7th Floor, Richmond, VA 23219, and must include the following:

a. All information required from the telephone notification included in this subsection;

b. The probable cause of the event, including all factors that contributed to the event and the manufacturer and model number (if applicable) of any equipment that failed or malfunctioned;

c. Corrective actions taken or planned to prevent occurrence of similar or identical events in the future and the results of any evaluations or assessments; and

d. For licenses subject to 10 CFR Part 70 Subpart H, whether the event was identified and evaluated in the integrated safety analysis.

D. In addition to the notifications required by 12VAC5-481-1100 or subsections A and B of this section, each licensee shall submit a written report within 30 days after learning of any of the following occurrences, either by mail or by hand delivery, to the agency at 109 Governor Street, 7th Floor, Richmond, VA 23219:

1. Any incident for which notification is required by 12VAC5-481-1100 or subsections A and B of this section;

2. Doses in excess of any of the following:

a. The occupational dose limits for adults in 12VAC5-481-640;

b. The occupational dose limits for a minor in 12VAC5-481-700;

c. The limits for an embryo/fetus of a declared pregnant woman in 12VAC5-481-710;

d. The limits for an individual member of the public in 12VAC5-481-720;

e. Any applicable limits in the license; or

f. The ALARA constraints for air emissions established under 12VAC5-481-630 D;

3. Levels of radiation or concentrations of radioactive material in:

a. A restricted area in excess of any applicable limit in the license; or

b. An unrestricted area in excess of 10 times any applicable limit set forth in this part or in the license, whether or not involving exposure of any individual in excess of the limits in 12VAC5-481-720; or

4. For licensee subject to the provisions of the U.S. Environmental Protection Agency's generally applicable environmental radiation standards in 40 CFR Part 190, levels of radiation or releases of radioactive materials in excess of those standards, or of license conditions related to those standards.

E. Each report, required by subsection A of this section shall:

1. Describe the extent of exposure of individuals to radiation and radioactive material, including, as appropriate:

a. A description of the event, including the probable cause, the exact location, the isotopes and quantities, chemical and physical form of the licensed material involved, date and time of the event, and if applicable, the manufacturer and model number of any equipment that failed or malfunctioned;

b. Estimates of each individual's dose;

c. The levels of radiation and concentrations of radioactive material involved;

d. The cause of the elevated exposures, dose rates, or concentrations; and

e. Corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, ALARA constraints, generally applicable environmental standards, and associated license conditions and the results of all evaluations or assessments.

2. Include for each individual the name, social security number, and date of birth. With respect to the limit for the embryo/fetus, the identifiers should be those of the declared pregnant woman. The report shall be prepared so that this information is stated in a separate and detachable part of the report and shall be clearly labeled for protection under privacy laws.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 34, Issue 2, eff. October 18, 2017; Errata, 39:5 VA.R. 943 October 24, 2022.

12VAC5-481-1120 Reports of planned special exposures

The licensee or registrant shall submit a written report to the agency within 30 days following any planned special exposure conducted in accordance with 12VAC5-481-690, informing the agency that a planned special exposure was conducted and indicating the date the planned special exposure occurred and the information required by 12VAC5-481-1030.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-1130 Reports of individual monitoring

A. This section applies to each person licensed or registered by the agency to:

1. Possess or use sources of radiation for purposes of industrial radiography pursuant to Parts III (12VAC5-481-380 et seq.) and V (12VAC5-481-1170 et seq.) of this chapter; or

2. Receive radioactive waste from other persons for disposal pursuant to Part XI (12VAC5-481-2330 et seq.) of this chapter; or

3. Possess or use at any time, for processing or manufacturing for distribution pursuant to Part III (12VAC5-481-380 et seq.) or VII (12VAC5-481-1660 et seq.) of this chapter, radioactive material in quantities exceeding any one of the following quantities:

| Radionuclide | Activity^a GBq | Ci | | --- | --- | --- | | Cesium-137 | 37 | 1 | | Cobalt-60 | 37 | 1 | | Gold-98 | 3,700 | 100 | | Iodine-131 | 37 | 1 | | Iridium-192 | 270 | 10 | | Krypton-85 | 37,000 | 1,000 | | Promethium-147 | 370 | 10 | | Technecium-99m | 37,000 | 1,000 | | ^aThe agency may require as a license condition, or by rule, regulation, or an order pursuant to 12VAC5-481-190, reports from licensees or registrants who are licensed or registered to use radionuclides not on this list, in quantities sufficient to cause comparable radiation levels. | | |

B. Each licensee or registrant in a category listed in subsection A of this section shall submit an annual report of the results of individual monitoring carried out by the licensee or registrant for each individual for whom monitoring was required by 12VAC5-481-760 during that year. The licensee or registrant may include additional data for individuals for whom monitoring was provided but not required. The licensee or registrant shall use the agency's record of individual monitoring results form or equivalent or electronic media containing all the information required by the agency's record of individual monitoring results form.

C. The licensee or registrant shall file the report required by subsection B of this section, covering the preceding year, on or before April 30 of each year. The licensee or registrant shall submit the report to the agency.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1140 Notifications and reports to individuals

A. Requirements for notification and reports to individuals of exposure to radiation or radioactive material are specified in 12VAC5-481-2280.

B. When a licensee or registrant is required pursuant to 12VAC5-481-1110 to report to the agency any exposure of an individual to radiation or radioactive material, the licensee or registrant shall also notify the individual. Such notice shall be transmitted at a time not later than the transmittal to the agency, and shall comply with the provisions of 12VAC5-481-2280 A.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-1150 Reports of leaking or contaminated sealed sources

The licensee or registrant shall file a report within five days with the agency if the test for leakage or contamination required pursuant to 12VAC5-481-740 indicates a sealed source is leaking or contaminated. The report shall include the equipment involved, the test results and the corrective action taken.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-1151 Reports of transactions involving nationally tracked sources

A. Each licensee who manufactures a nationally tracked source shall complete and submit a National Source Tracking Transaction Report. The report must include the following information:

1. The name, address, and license number of the reporting licensee;

2. The name of the individual preparing the report;

3. The manufacturer, model, and serial number of the source;

4. The radioactive material in the source;

5. The initial source strength in becquerels (curies) at the time of manufacture; and

6. The manufacture date of the source.

B. Each licensee that transfers a nationally tracked source to another person shall complete and submit a National Source Tracking Transaction Report. The report must include the following information:

1. The name, address, and license number of the reporting licensee;

2. The name of the individual preparing the report;

3. The name and license number of the recipient facility and the shipping address;

4. The manufacturer, model, and serial number of the source or, if not available, other information to uniquely identify the source;

5. The radioactive material in the source;

6. The initial or current source strength in becquerels (curies);

7. The date for which the source strength is reported;

8. The shipping date;

9. The estimated arrival date; and

10. For nationally tracked sources transferred as waste under a Uniform Low-Level Radioactive Waste Manifest, the waste manifest number and the container identification of the container with the nationally tracked source.

C. Each licensee that receives a nationally tracked source shall complete and submit a National Source Tracking Transaction Report. The report must include the following information:

1. The name, address, and license number of the reporting licensee;

2. The name of the individual preparing the report;

3. The name, address, and license number of the person that provided the source;

4. The manufacturer, model, and serial number of the source or, if not available, other information to uniquely identify the source;

5. The radioactive material in the source;

6. The initial or current source strength in becquerels (curies);

7. The date for which the source strength is reported;

8. The date of receipt; and

9. For material received under a Uniform Low-Level Radioactive Waste Manifest, the waste manifest number and the container identification with the nationally tracked source.

D. Each licensee that disassembles a nationally tracked source shall complete and submit a National Source Tracking Transaction Report. The report must include the following information:

1. The name, address, and license number of the reporting licensee;

2. The name of the individual preparing the report;

3. The manufacturer, model, and serial number of the source or, if not available, other information to uniquely identify the source;

4. The radioactive material in the source;

5. The initial or current source strength in becquerels (curies);

6. The date for which the source strength is reported; and

7. The disassemble date of the source.

E. Each licensee who disposes of a nationally tracked source shall complete and submit a National Source Tracking Transaction Report. The report must include the following information:

1. The name, address, and license number of the reporting licensee;

2. The name of the individual preparing the report;

3. The waste manifest number;

4. The container identification with the nationally tracked source;

5. The date of disposal; and

6. The method of disposal.

F. The reports discussed in subsections A through E of this section must be submitted by the close of the next business day after the transaction. A single report may be submitted for multiple sources and transactions. The reports must be submitted to the National Source Tracking System by using:

1. The online National Source Tracking System;

2. Electronically using a computer-readable format;

3. By facsimile;

4. By mail to the address on the National Source Tracking Transaction Report Form (NRC Form 748); or

5. By telephone with followup by facsimile or mail.

G. Each licensee shall correct any error in previously filed reports or file a new report for any missed transaction within five business days of the discovery of the error or missed transaction. Such errors may be detected by a variety of methods such as administrative reviews or by physical inventories required by regulation. In addition, each licensee shall reconcile the inventory of nationally tracked sources possessed by the licensee against that licensee's data in the National Source Tracking System. The reconciliation must be conducted during the month of January in each year. The reconciliation process must include resolving any discrepancies between the National Source Tracking System and the actual inventory by filing the reports identified by subsections A through E of this section. By January 31 of each year, each licensee must submit to the National Source Tracking System confirmation that the data in the National Source Tracking System is correct.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 14 Additional Requirements

12VAC5-481-1160 (Repealed.)

Article 14 Additional Requirements

History

• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; repealed, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1161 Radiological criteria for license termination

A. General provisions and applicability.

1. This part applies to the decommissioning of facilities licensed under this chapter.

2. This part does not apply to sites that:

a. Have been decommissioned before the effective date as stated in 12VAC5-481-160; or

b. Have previously submitted and received NRC's approval on a license termination plan or decommissioning plan.

3. After a site has been decommissioned and the license terminated according to this section, the agency shall require additional cleanup only if, based on new information, the agency determines that the criteria of this part were not met and residual radioactivity remaining at the site could result in a significant threat to public health and safety.

4. When calculating the Total Effective Dose Equivalent (TEDE) to the average member of the critical group, the licensee shall determine the peak annual TEDE expected within the first 1,000 years after decommissioning.

B. Radiological criteria for unrestricted use. A site is considered acceptable for unrestricted use if the residual radioactivity that is distinguishable from background radiation results in a TEDE to an average member of the critical group that does not exceed 0.25 mSv (25 mrem) per year, including that from groundwater sources of drinking water; and the residual radioactivity has been reduced to levels that are ALARA. Determination of levels that are ALARA shall take into account consideration of any detriments, such as deaths from transportation accidents, expected to potentially result from decontamination and waste disposal.

C. Criteria for termination under restricted conditions. A site is considered acceptable for license termination under restricted conditions, if the licensee:

1. Can demonstrate that further reductions in residual radioactivity necessary to comply with subsection B of this section would result in net public or environmental harm or are not being made because the residual levels associated with restricted conditions are ALARA. Determination of the levels that are ALARA shall take into account consideration of any detriments, such as traffic accidents, expected to potentially result from decontamination and waste disposal;

2. Has made provisions for legally enforceable institutional controls that provide reasonable assurance that the TEDE from residual radioactivity, distinguishable from background radiation, will not exceed 0.25 mSv (25 mrem) per year to the average member of the critical group;

3. Has provided sufficient financial assurance to enable an independent third party, including a governmental custodian of a site, to assume and carry out responsibilities for any necessary control and maintenance of the site. Acceptable financial assurance mechanisms are:

a. Funds placed into an account segregated from the licensee's assets and outside the licensee's administrative control as described under 12VAC5-481-450 C 7 a;

b. Surety method, insurance, or other guarantee method as described under part 12VAC5-481-450 C 7 b;

c. A statement of intent, in the case of federal, state, or local government licensees, as described in 12VAC5-481-450 C 7 d; or

d. When a governmental entity is assuming custody and ownership of a site, an arrangement that is deemed acceptable by the governmental entity;

4. Has submitted a decommissioning plan or a license termination plan to the agency indicating the licensee's intent to decommission according to 12VAC5-481-510 and specifying that the licensee intends to decommission by restricting use of the site. The licensee shall document in the license termination plan or decommissioning plan how the advice of individuals and institutions in the community has been sought according to subdivisions 5 and 6 of this subsection and incorporated, as appropriate, following analysis of that advice;

5. If proposing to decommission by restricting use of the site, seeks advice from individuals and institutions in the community who may be affected by the decommissioning regarding whether:

a. Institutional controls proposed by the licensee:

(1) Will provide reasonable assurance that the TEDE from residual radioactivity distinguishable from background radiation to the average member of the critical group will not exceed 0.25 mSv (25 mrem) TEDE per year;

(2) Will be enforceable; and

(3) Will not impose undue burdens on the local community or other affected parties; and

b. The licensee has provided sufficient financial assurance to enable an independent third party, including a governmental custodian of a site, to assume and carry out responsibilities for any necessary control and maintenance of the site;

6. While seeking advice under subdivision 5 of this subsection, provides for:

a. Participation by representatives of a broad cross section of community interests who may be affected by the decommissioning;

b. An opportunity for a comprehensive, collective discussion on the issues by the participants represented; and

c. A publicly available summary of the results of all such discussions, including a description of the individual viewpoints of the participants on the issues and the extent of agreement and disagreement among the participants on the issues; and

7. Reduces residual radioactivity at the site so that if the institutional controls were no longer in effect, there is reasonable assurance that the TEDE from residual radioactivity distinguishable from background radiation to the average member of the critical group is ALARA and would not exceed:

a. 1 mSv (100 mrem) per year; or

b. 5 mSv (500 mrem) per year, if the licensee:

(1) Demonstrates that further reductions in residual radioactivity necessary to comply with subdivision C 7 a of this section are not technically achievable, would be prohibitively expensive, or would result in net public or environmental harm;

(2) Makes provisions for durable institutional controls; and

(3) Provides sufficient financial assurance, according to subdivision C 3 of this section, to enable a responsible governmental entity or independent third party, including a governmental custodian of a site, to carry out periodic rechecks of the site no less frequently than every five years to ensure that the institutional controls remain in place as necessary to meet the criteria of subdivision C 2 of this section, and to assume and carry out responsibilities for any necessary control and maintenance of those controls.

D. Alternative criteria for license termination.

1. The agency may terminate a license using alternative criteria greater than the dose criterion of subsection B and subdivision C 5 a (1) of this section, if the licensee:

a. Provides assurance that public health and safety would continue to be protected and that it is unlikely that the dose from all manmade sources combined, other than medical, would be more than the 1 mSv (100 mrem) per year limit under 12VAC5-481-720, by submitting an analysis of possible sources of exposure;

b. Employs, to the extent practical, restrictions on site use according to subsection C of this section, in minimizing exposures at the site;

c. Reduces doses to ALARA levels, taking into consideration any detriments, such as traffic accidents, expected to potentially result from decontamination and waste disposal; and

d. Submits a decommissioning plan or license termination plan to the agency indicating the licensee's intent to decommission according to 12VAC5-481-510, and specifying that the licensee proposes to decommission by use of alternate criteria. The licensee shall document in the decommissioning plan or license termination plan how the advice of individuals and institutions in the community who may be affected by the decommissioning has been sought and addressed, as appropriate, following analysis of that advice. In seeking such advice, the licensee shall provide for:

(1) Participation by representatives of a broad cross section of community interests who may be affected by the decommissioning;

(2) An opportunity for a comprehensive, collective discussion on the issues by the participants represented; and

(3) A publicly available summary of the results of all such discussions, including a description of the individual viewpoints of the participants on the issues and the extent of agreement and disagreement among the participants on the issues.

2. Has provided sufficient financial assurance in the form of a trust fund to enable an independent third party, including a governmental custodian of a site, to assume and carry out responsibilities for any necessary control and maintenance of the site.

3. The use of alternate criteria to terminate a license requires the approval of the agency after consideration of staff recommendations of the agency that address any comments provided by federal, state, and local governments and any public comments submitted pursuant under subsection E of this section.

E. Public notification and public participation. Upon receipt of a license termination plan or decommissioning plan from a licensee or a proposal by a licensee for release of a site according to subsection C or D of this section, or whenever the agency deems such notice to be in the public interest, the agency shall:

1. Notify and solicit comments from:

a. Local and state governments in the vicinity of the site and any Indian Nation or other indigenous people that have treaty or statutory rights that could be affected by the decommissioning; and

b. The U.S. Environmental Protection Agency and Virginia Department of Environmental Quality for cases when the licensee proposes to release a site according to subsection D of this section; and

2. Publish a notice in the Virginia Register of Regulations and in a forum, such as local newspapers, letters to state and local organizations, or other appropriate forum, that is readily accessible to individuals in the vicinity of the site and solicit comments from affected parties.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008; amended, Virginia Register Volume 32, Issue 24, eff. August 25, 2016.

Article 1 General Requirements

12VAC5-481-1170 Purpose

Article 1 General Requirements

This part prescribes requirements for the issuance of licenses or registrations for the industrial use of sources of radiation and radiation safety requirements for persons using these sources of radiation in industrial radiography.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-1180 Scope

The provisions and requirements of this part are in addition to, and not in substitution for, other requirements of these regulations. In particular, the general requirements and provisions of Parts I (12VAC5-481-10 et seq.); II (12VAC5-481-260 et seq.); III (12VAC5-481-380 et seq.); IV (12VAC5-481-600 et seq.); X (12VAC5-481-2250 et seq.) and XIII (12VAC5-481-2950 et seq.), of this chapter apply to applicants, licensees and registrants subject to this part. Parts III (12VAC5-481-380 et seq.) and XIII (12VAC5-481-2950 et seq.) of this chapter apply to licensing and transportation of radioactive material and Part II (12VAC5-481-260 et seq.) of this chapter applies to the registration of radiation machines. Except for sections that are applicable only to sealed radioactive sources, radiation machines and sealed radioactive sources are both covered by this part. This regulation does not apply to medical uses of sources of radiation that are addressed in Parts VII (12VAC5-481-1660 et seq.) and XV (12VAC5-481-3380 et seq.) of this chapter.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-1190 Exemptions

A. Uses of certified and certifiable cabinet X-ray systems are exempt from the requirements of this part except for 12VAC5-481-1200 and the following:

1. For certified and certifiable cabinet X-ray systems, including those designed to allow admittance of individuals:

a. No registrant shall permit any individual to operate a cabinet X-ray system until the individual has received a copy of and instruction in the operating procedures for the unit. Records that demonstrate compliance with this subdivision shall be maintained for agency inspection until disposal is authorized by the agency.

b. Tests for proper operation of interlocks must be conducted and recorded at intervals not to exceed six months. Records of these tests shall be maintained for agency inspection until disposal is authorized by the agency.

c. The registrant shall perform an evaluation of the radiation dose limits to determine compliance with 12VAC5-481-720 and 21 CFR 1020.40, Cabinet X-ray Systems, at intervals not to exceed one year. Records of these evaluations shall be maintained for agency inspection for two years after the evaluation.

2. Certified cabinet X-ray systems shall be maintained in compliance with 21 CFR 1020.40, Cabinet X-ray Systems, and no modification shall be made to the system unless prior agency approval has been granted.

B. Industrial uses of hand-held light intensified imaging devices are exempt from the requirements of exceed 0.2 mSv (2 mrem) per hour. Devices that exceed this limit shall meet the applicable requirements of this part and the licensing or registration requirements of Part II (12VAC5-481-260 et seq.) or Part III (12VAC5-481-380 et seq.) of this chapter, as applicable.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1200 Licensing and registration requirements for industrial radiography operations

A. The agency will approve an application for a specific license for the use of licensed material or a registration for use of radiation machines if the applicant meets the following requirements:

1. The applicant satisfies the general requirements specified in Part II (12VAC5-481-260 et seq.) for radiation machine facilities or Part III (12VAC5-481-380 et seq.) for radioactive material, as applicable, and any special requirements contained in this part;

2. The applicant submits an adequate program for training radiographers and radiographer's assistants that meets the requirements of 12VAC5-481-1320;

3. The applicant submits procedures for verifying and documenting the certification status of radiographers and for ensuring that the certification of individuals acting as radiographers remains valid;

4. The applicant submits written operating and emergency procedures as described in 12VAC5-481-1330;

5. The applicant submits a description of a program for inspections of the job performance of each radiographer and radiographer's assistant at intervals not to exceed six months as described in 12VAC5-481-1320 E;

6. The applicant submits a description of the applicant's overall organizational structure as it applies to the radiation safety responsibilities in industrial radiography, including specified delegation of authority and responsibility;

7. The applicant submits the qualifications of the individual(s) designated as the radiation safety officer as described in 12VAC5-481-1310 A 1;

8. If an applicant intends to perform leak testing of sealed sources or exposure devices containing depleted uranium (DU) shielding, the applicant must describe the procedures for performing the test. The description must include the:

a. Methods of collecting the samples;

b. Qualifications of the individual who analyzes the samples;

c. Instruments to be used; and

d. Methods of analyzing the samples;

9. If the applicant intends to perform calibrations of survey instruments and alarming ratemeters, the applicant must describe methods to be used and the experience of the person(s) who will perform the calibrations. All calibrations must be performed according to the procedures described and at the intervals prescribed in 12VAC5-481-1240 and 12VAC5-481-1350 G 4;

10. The applicant identifies and describes the location(s) of all field stations and permanent radiographic installations;

11. The applicant identifies the location(s) where all records required by this and other parts of these regulations will be maintained;

12. If a license application includes underwater radiography, a description of:

a. Radiation safety procedures and radiographer responsibilities unique to the performance of underwater radiography;

b. Radiographic equipment and radiation safety equipment unique to underwater radiography; and

c. Methods for gas-tight encapsulation of equipment; and

13. If an application includes offshore platform and/or lay-barge radiography, a description of:

a. Transport procedures for radioactive material to be used in industrial radiographic operations;

b. Storage facilities for radioactive material; and

c. Methods for restricting access to radiation areas.

B. A license or registration will be issued if the requirements of subsection A of this section, as applicable, are met.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1210 Performance requirements for industrial radiography equipment

A. Equipment used in industrial radiographic operations must meet the following minimum criteria:

Each radiographic exposure device, source assembly or sealed source, and all associated equipment must meet the requirements specified in American National Standard Institute, N432‑1980 "Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography," (published as NBS Handbook 136, issued January 1981). This publication may be purchased from the American National Standards Institute, Inc., 25 West 43rd Street, New York, NY 10036; telephone (212) 642‑4900 .

B. In addition to the requirements specified in this section the following requirements apply to radiographic exposure devices, source changers, source assemblies and sealed sources:

1. The licensee shall ensure that each radiographic exposure device has attached to it a durable, legible, clearly visible label bearing the:

a. Chemical symbol and mass number of the radionuclide in the device;

b. Activity and the date on which this activity was last measured;

c. Model or product code and serial number of the sealed source;

d. Name of the manufacturer of the sealed source; and

e. Licensee's name, address, and telephone number.

2. Radiographic exposure devices intended for use as Type B packages must meet the applicable transportation requirements of Part XIII (12VAC5-481-2950 et seq.) of this chapter.

3. Modification of radiographic exposure devices, source changers, and source assemblies and associated equipment is prohibited, unless approved by the agency or other approval body.

C. In addition to the requirements specified in subsections A and B of this section, the following requirements apply to radiographic exposure devices, source assemblies, and associated equipment that allow the source to be moved out of the device for radiographic operations or to source changers:

1. The coupling between the source assembly and the control cable must be designed in such a manner that the source assembly will not become disconnected if cranked outside the guide tube. The coupling must be such that it cannot be unintentionally disconnected under normal and reasonably foreseeable abnormal conditions.

2. The device must automatically secure the source assembly when it is cranked back into the fully shielded position within the device. This securing system may only be released by means of a deliberate operation on the exposure device.

3. The outlet fittings, lock box, and drive cable fittings on each radiographic exposure device must be equipped with safety plugs or covers that must be installed during storage and transportation to protect the source assembly from water, mud, sand or other foreign matter.

4. Each sealed source or source assembly must have attached to it or engraved on it, a durable, legible, visible label with the words:

"DANGER—RADIOACTIVE."

The label may not interfere with the safe operation of the exposure device or associated equipment.

5. The guide tube must be able to withstand a crushing test that closely approximates the crushing forces that are likely to be encountered during use, and be able to withstand a kinking resistance test that closely approximates the kinking forces that are likely to be encountered during use.

6. Guide tubes must be used when moving the source out of the device.

7. An exposure head or similar device designed to prevent the source assembly from passing out of the end of the guide tube must be attached to the outermost end of the guide tube during industrial radiography operations.

8. The guide tube exposure head connection must be able to withstand the tensile test for control units specified in ANSI N432‑1980.

9. Source changers must provide a system for ensuring that the source will not be accidentally withdrawn from the changer when connecting or disconnecting the drive cable to or from a source assembly.

D. All radiographic exposure devices and associated equipment in use after January 10, 1996, must comply with the requirements of this section.

E. As an exception to subsection A of this section, equipment used in industrial radiographic operations need not comply with 8.9.2(c) of the Endurance Test in American National Standards Institute N432‑1980, if the prototype equipment has been tested using a torque value representative of the torque that an individual using the radiography equipment can reasonably exert on the lever or crankshaft of the drive mechanism.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 33, Issue 11, eff. February 22, 2017.

12VAC5-481-1220 Limits on external radiation levels from storage containers and source changers

The maximum exposure rate limits for storage containers and source changers are 2 mSv (200 mrem) per hour at any exterior surface, and 0.1 mSv (10 mrem) per hour at one meter from any exterior surface with the sealed source in the shielded position.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1230 Locking of sources of radiation, storage containers and source changers

A. Each radiographic exposure device must have a lock or outer locked container designed to prevent unauthorized or accidental removal of the sealed source from its shielded position. The exposure device and/or its container must be kept locked, and if a keyed-lock, with the key removed at all times, when not under the direct surveillance of a radiographer or a radiographer's assistant except at permanent radiographic installations as stated in 12VAC5-481-1370. In addition, during radiographic operations the sealed source assembly must be secured in the shielded position each time the source is returned to that position.

B. Each sealed source storage container and source changer must have a lock or outer locked container designed to prevent unauthorized or accidental removal of the sealed source from its shielded position. Storage containers and source changers must be kept locked, and if a keyed-lock, with the key removed at all times, when containing sealed sources except when under the direct surveillance of a radiographer or a radiographer's assistant.

C. The control panel of each radiation machine shall be equipped with a lock that will prevent the unauthorized use of an X-ray system or the accidental production of radiation. The radiation machine shall be kept locked and the key removed at all times except when under the direct visual surveillance of a radiographer or a radiographer's assistant.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1240 Radiation survey instruments

A. The licensee or registrant shall keep sufficient calibrated and operable radiation survey instruments at each location where sources of radiation are present to make the radiation surveys required by this part and by Part IV (12VAC5-481-600 et seq.) of this chapter. Instrumentation required by this section must be capable of measuring a range from 0.02 mSv (2 mrem) per hour through 0.01 Sv (1 rem) per hour.

B. The licensee or registrant shall have each radiation survey instrument required under subsection A of this section calibrated:

1. At energies appropriate for use and at intervals not to exceed six months or after instrument servicing, except for battery changes;

2. For linear scale instruments, at two points located approximately one-third and two-thirds of full-scale on each scale; for logarithmic scale instruments, at mid-range of each decade, and at two points of at least one decade; and for digital instruments, at three points between 0.02 and 10 mSv (2 and 1000 mrem) per hour; and

3. So that an accuracy within plus or minus 20% of the true radiation dose rate can be demonstrated at each point checked.

C. The licensee or registrant shall maintain records of the results of the instrument calibrations in accordance with 12VAC5-481-1410.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1250 Leak testing and replacement of sealed sources

A. The replacement of any sealed source fastened to or contained in a radiographic exposure device and leak testing of any sealed source must be performed by persons authorized to do so by the agency, the NRC, or another agreement state.

B. The opening, repair, or modification of any sealed source must be performed by persons specifically authorized to do so by the agency, the NRC, or another agreement state.

C. Testing and recordkeeping requirements.

1. Each licensee who uses a sealed source shall have the source tested for leakage at intervals not to exceed six months. The leak testing of the source must be performed using a method approved by the agency, the NRC, or by another agreement state. The wipe sample should be taken from the nearest accessible point to the sealed source where contamination might accumulate. The wipe sample must be analyzed for radioactive contamination. The analysis must be capable of detecting the presence of 185 Bq (0.005 μCi) of radioactive material on the test sample and must be performed by a person specifically authorized by the agency, the NRC, or another agreement state to perform the analysis.

2. The licensee shall maintain records of the leak tests in accordance with 12VAC5-481-1420.

3. Unless a sealed source is accompanied by a certificate from the transferor that shows that it has been leak tested within six months before the transfer, it may not be used by the licensee until tested for leakage. Sealed sources that are in storage and not in use do not require leak testing, but must be tested before use or transfer to another person if the interval of storage exceeds six months.

D. Any test conducted pursuant to subsections B and C of this section that reveals the presence of 185 Bq (0.005 μCi) or more of removable radioactive material must be considered evidence that the sealed source is leaking. The licensee shall immediately withdraw the equipment involved from use and shall have it decontaminated and repaired or disposed of in accordance with agency regulations. A report must be filed with the agency within five days of any test with results that exceed the threshold in this paragraph, describing the equipment involved, the test results, and the corrective action taken.

E. Each exposure device using depleted uranium (DU) shielding and an "S" tube configuration must be tested for DU contamination at intervals not to exceed 12 months. The analysis must be capable of detecting the presence of 185 Bq (0.005 μCi) of radioactive material on the test sample and must be performed by a person specifically authorized by the agency, the NRC, or another agreement state to perform the analysis. Should such testing reveal the presence of DU contamination, the exposure device must be removed from use until an evaluation of the wear of the S-tube has been made. Should the evaluation reveal that the S-tube is worn through, the device may not be used again. DU shielded devices do not have to be tested for DU contamination while not in use and in storage. Before using or transferring such a device, however, the device must be tested for DU contamination, if the interval of storage exceeds 12 months. A record of the DU leak test must be made in accordance with 12VAC5-481-1420.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1260 Quarterly inventory

A. Each licensee or registrant shall conduct a quarterly physical inventory to account for all sources of radiation, and for devices containing depleted uranium received and possessed under the license.

B. The licensee or registrant shall maintain records of the quarterly inventory in accordance with 12VAC5-481-1430.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-1270 Inspection and maintenance of radiation machines, radiographic exposure devices, transport and storage containers, associated equipment, source ...

A. The licensee or registrant shall perform visual and operability checks on survey meters, radiation machines, radiographic exposure devices, transport and storage containers, associated equipment and source changers before each day's use, or work shift, to ensure that:

1. The equipment is in good working condition;

2. The sources are adequately shielded; and

3. Required labeling is present.

B. Survey instrument operability must be performed using check sources or other appropriate means.

C. If equipment problems are found, the equipment must be removed from service until repaired.

D. Each licensee or registrant shall have written procedures for and perform inspection and routine maintenance of radiation machines, radiographic exposure devices, source changers, associated equipment, transport and storage containers, and survey instruments at intervals not to exceed three months or before the first use thereafter to ensure the proper functioning of components important to safety. If equipment problems are found, the equipment must be removed from service until repaired. Replacement components shall meet design requirements.

E. The licensee's inspection and maintenance program must include procedures to assure that Type B packages are shipped and maintained in accordance with the certificate of compliance or other approval.

F. Records of equipment problems and of any maintenance performed under this section must be made in accordance with 12VAC5-481-1450.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1280 Permanent radiographic installations

A. Each entrance that is used for personnel access to the high radiation area in a permanent radiographic installation must have either:

1. An entrance control of the type described in 12VAC5-481-780 that causes the radiation level upon entry into the area to be reduced; or

2. Both conspicuous visible and audible warning signals to warn of the presence of radiation. The visible signal must be actuated by radiation whenever the source is exposed or the machine is energized. The audible signal must be actuated when an attempt is made to enter the installation while the source is exposed or the machine is energized.

B. The alarm system must be tested for proper operation with a radiation source each day before the installation is used for radiographic operations. The test must include a check of both the visible and audible signals. Entrance control devices that reduce the radiation level upon entry as designated in subdivision A 1 of this section must be tested monthly. If an entrance control device or an alarm is operating improperly, it must be immediately labeled as defective and repaired within seven calendar days. The facility may continue to be used during this seven-day period, provided the licensee or registrant implements the continuous surveillance requirements of 12VAC5-481-1370 and uses an alarming ratemeter. Test records for entrance controls and audible and visual alarms must be maintained in accordance with 12VAC5-481-1460.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-1290 Labeling, storage, and transportation

A. Licensees may not use a source changer or a container to store radioactive material unless the source changer or the storage container has securely attached to it a durable, legible, and clearly visible label bearing the standard trefoil radiation caution symbol conventional colors, i.e., magenta, purple, or black on a yellow background, having a minimum diameter of 25 mm, and the wording:

CAUTION *

RADIOACTIVE MATERIAL

NOTIFY CIVIL AUTHORITIES (or "NAME OF COMPANY")

• ——or "DANGER"

B. Licensees may not transport radioactive material unless the material is packaged, and the package is labeled, marked, and accompanied with appropriate shipping papers in accordance with regulations set out in Part XIII (12VAC5-481-2950 et seq.) of this chapter.

C. Radiographic exposure devices, source changers, storage containers, and radiation machines, shall be physically secured to prevent tampering or removal by unauthorized personnel. The licensee shall store radioactive material in a manner that will minimize danger from explosion or fire.

D. Licensees shall lock and physically secure the transport package containing radioactive material in the transporting vehicle to prevent accidental loss, tampering, or unauthorized removal.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 32, Issue 24, eff. August 25, 2016.

Article 2 Radiation Safety Requirements

12VAC5-481-1300 Conducting industrial radiographic operations

Article 2 Radiation Safety Requirements

A. Whenever radiography is performed at a location other than a permanent radiographic installation, the radiographer must be accompanied by at least one other qualified radiographer or an individual who has at a minimum met the requirements of 12VAC5-481-1320 C. The additional qualified individual shall observe the operations and be capable of providing immediate assistance to prevent unauthorized entry. Radiography may not be performed if only one qualified individual is present.

B. All radiographic operations must be conducted in a permanent radiographic installation unless otherwise specifically authorized by the agency.

C. Except when physically impossible, collimators shall be used in industrial radiographic operations that use radiographic exposure devices that allow the source to be moved out of the device.

D. A licensee or registrant may conduct lay-barge, offshore platform, or underwater radiography only if procedures have been approved by the agency, the NRC, or by another agreement state.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1310 Radiation safety officer

A. The radiation safety officer shall ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee's or registrant's program.

B. The minimum qualifications, training, and experience for radiation safety officers for industrial radiography are as follows:

1. Completion of the training and testing requirements of 12VAC5-481-1320 A;

2. 2000 hours of hands-on experience as a qualified radiographer in industrial radiographic operations; and

3. Formal training in the establishment and maintenance of a radiation protection program.

C. The agency will consider alternatives when the radiation safety officer has appropriate training and experience in the field of ionizing radiation, and in addition, has adequate formal training with respect to the establishment and maintenance of a radiation safety protection program.

D. The specific duties and authorities of the radiation safety officer include:

1. Establishing and overseeing all operating, emergency, and ALARA procedures as required by Part IV (12VAC5-481-600 et seq.) of this chapter and reviewing them regularly to ensure that they conform to agency regulations and to the license or registration conditions;

2. Overseeing and approving the training program for radiographic personnel to ensure that appropriate and effective radiation protection practices are taught;

3. Ensuring that required radiation surveys and leak tests are performed and documented in accordance with the regulations, including any corrective measures when levels of radiation exceed established limits;

4. Ensuring that personnel monitoring devices are calibrated, if applicable, and used properly; that records are kept of the monitoring results; and that timely notifications are made as required by Part IV of this chapter; and

5. Ensuring that operations are conducted safely and for implementing corrective actions including terminating operations.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1320 Training

A. The licensee or registrant may not permit any individual to act as a radiographer until the individual has received at least 40 hours of training in the subjects outlined in subsection G of this section in addition to on the job training consisting of hands-on experience under the supervision of a radiographer and is certified through a radiographer certification program by a certifying entity meeting the requirements of 10 CFR Part 34, Appendix A. The on-the-job training shall include a minimum of two months (320 hours) of active participation in the performance of industrial radiography utilizing radioactive material and/or one month (160 hours) of active participation in the performance of industrial radiography utilizing radiation machines. Individuals performing industrial radiography utilizing radioactive materials and radiation machines must complete both segments of the on-the-job training (3 months or 480 hours).

B. In addition, the licensee or registrant may not permit any individual to act as a radiographer until the individual:

1. Has received copies of and instruction in the requirements described in the regulations contained in this part, 12VAC5-481-30 and applicable sections of Parts IV (12VAC5-481-600 et seq.), X (12VAC5-481-2250 et seq.), and XIII (12VAC5-481-2950 et seq.) of this chapter, in the license or registration under which the radiographer will perform industrial radiography, and the licensee's or registrant's operating and emergency procedures;

2. Has demonstrated an understanding of items in subdivision 1 of this subsection by successful completion of a written examination;

3. Has received training in the use of the registrant's radiation machines, or the licensee's radiographic exposure devices, sealed sources, in the daily inspection of devices and associated equipment, and in the use of radiation survey instruments; and

4. Has demonstrated understanding of the use of the equipment described in subdivision 3 of this subsection by successful completion of a practical examination.

C. The licensee or registrant may not permit any individual to act as a radiographer's assistant until the individual:

1. Has received copies of and instruction in the requirements described in the regulations contained in this part, 12VAC5-481-30 and applicable sections of Parts IV (12VAC5-481-600 et seq.), X (12VAC5-481-2250 et seq.), and XIII (12VAC5-481-2950 et seq.) of this chapter, in the license or registration under which the radiographer's assistant will perform industrial radiography, and the licensee's or registrant's operating and emergency procedures;

2. Has demonstrated an understanding of items in subdivision 1 of this subsection by successful completion of a written examination;

3. Under the personal supervision of a radiographer, has received training in the use of the registrant's radiation machines, or the licensee's radiographic exposure devices and sealed sources, in the daily inspection of devices and associated equipment, and in the use of radiation survey instruments; and

4. Has demonstrated understanding of the use of the equipment described in subdivision 3 of this subsection by successful completion of a practical examination.

D. The licensee or registrant shall provide annual refresher safety training for each radiographer and radiographer's assistant at intervals not to exceed 12 months.

E. Except as provided in subdivision 4 of this subsection, the RSO or designee shall conduct an inspection program of the job performance of each radiographer and radiographer's assistant to ensure that the agency's regulations, license or registration requirements, and operating and emergency procedures are followed. The inspection program must:

1. Include observation of the performance of each radiographer and radiographer's assistant during an actual industrial radiographic operation, at intervals not to exceed six months;

2. Provide that, if a radiographer or a radiographer's assistant has not participated in an industrial radiographic operation for more than six months since the last inspection, the radiographer must demonstrate knowledge of the training requirements of subdivision B 3 of this section and the radiographer's assistant must demonstrate knowledge of the training requirements of subdivision C 3 of this section by a practical examination before these individuals can next participate in a radiographic operation;

3. The agency may consider alternatives in those situations where the individual serves as both radiographer and radiation safety officer; and

4. In those operations where a single individual serves as both radiographer and radiation safety officer, and performs all radiography operations, an inspection program is not required;

F. The licensee or registrant shall maintain records of the above training to include certification documents, writtenand practical examinations, refresher safety training and inspections of job performance in accordance with 12VAC5-481-1470.

G. The licensee or registrant shall include the following subjects required in subsection A of this section:

1. Fundamentals of radiation safety including:

a. Characteristics of gamma and x-radiation;

b. Units of radiation dose and quantity of radioactivity;

c. Hazards of exposure to radiation;

d. Levels of radiation from sources of radiation; and

e. Methods of controlling radiation dose (time, distance, and shielding);

2. Radiation detection instruments including:

a. Use, operation, calibration, and limitations of radiation survey instruments;

b. Survey techniques; and

c. Use of personnel monitoring equipment;

3. Equipment to be used including:

a. Operation and control of radiographic exposure equipment, remote handling equipment, and storage containers, including pictures or models of source assemblies (pigtails);

b. Operation and control of radiation machines;

c. Storage, control, and disposal of sources of radiation; and

d. Inspection and maintenance of equipment.

4. The requirements of pertinent state and federal regulations; and

5. Case histories of accidents in radiography.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1330 Operating and emergency procedures

A. Operating and emergency procedures must include, as a minimum, instructions in the following:

1. Appropriate handling and use of sources of radiation so that no person is likely to be exposed to radiation doses in excess of the limits established in Part IV (12VAC5-481-600 et seq.) of this chapter;

2. Methods and occasions for conducting radiation surveys;

3. Methods for posting and controlling access to radiographic areas;

4. Methods and occasions for locking and securing sources of radiation;

5. Personnel monitoring and the use of personnel monitoring equipment;

6. Transporting equipment to field locations, including packing of radiographic exposure devices and storage containers in the vehicles, placarding of vehicles when required, and control of the equipment during transportation as described in Part XIII (12VAC5-481-2950 et seq.) of this chapter;

7. The inspection, maintenance, and operability checks of radiographic exposure devices, radiation machines, survey instruments, alarming ratemeters, transport containers, and storage containers;

8. Steps that must be taken immediately by radiography personnel in the event a pocket dosimeter is found to be off-scale or an alarming ratemeter alarms unexpectedly;

9. The procedure(s) for identifying and reporting defects and noncompliance, as required by 12VAC5-481-1530;

10. The procedure for notifying proper persons in the event of an accident or incident;

11. Minimizing exposure of persons in the event of an accident or incident, including a source disconnect, a transport accident, or loss of a source of radiation;

12. Source recovery procedure if licensee will perform source recoveries; and

13. Maintenance of records.

B. The licensee or registrant shall maintain copies of current operating and emergency procedures in accordance with 12VAC5-481-1480 and 12VAC5-481-1520.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-1340 Supervision of radiographer's assistants

The radiographer's assistant shall be under the personal supervision of a radiographer when using sources of radiation or conducting radiation surveys required by subdivision 2 of 12VAC5-481-1360 to determine that the sealed source has returned to the shielded position or the radiation machine is off after an exposure. The personal supervision must include:

1. The radiographer's physical presence at the site where the sources of radiation are being used;

2. The availability of the radiographer to give immediate assistance if required; and

3. The radiographer's direct observation of the assistant's performance of the operations referred to in this section.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-1350 Personnel monitoring

A. The licensee or registrant may not permit any individual to act as a radiographer or a radiographer's assistant unless, at all times during radiographic operations, each individual wears, on the trunk of the body, a direct reading dosimeter, an operating alarming ratemeter, and a personnel dosimeter. At permanent radiographic installations where other appropriate alarming or warning devices are in routine use, or during radiographic operations using radiation machines, the wearing of an alarming ratemeter is not required.

1. Pocket dosimeters must have a range from 0 to 2 mSv (200 mrem) and must be recharged at the start of each shift. Electronic personal dosimeters may only be used in place of ion-chamber pocket dosimeters.

2. Each personnel dosimeter must be assigned to and worn by only one individual.

3. Film badges must be exchanged monthly, and all other dosimeters that require replacement must be exchanged at periods not to exceed three months. All personnel dosimeters must be evaluated at periods not to exceed three months or promptly after replacement, whichever is more frequent.

B. Direct reading dosimeters, such as pocket dosimeters or electronic personal dosimeters, must be read and the exposures recorded at the beginning and end of each shift, and records must be maintained in accordance with 12VAC5-481-1490.

C. Pocket dosimeters, or electronic personal dosimeters, must be checked at periods not to exceed 12 months for correct response to radiation, and records must be maintained in accordance with 12VAC5-481-1490. Acceptable dosimeters must read within plus or minus 20% of the true radiation exposure.

D. If an individual's pocket dosimeter is found to be off-scale, or the electronic personal dosimeter reads greater than 2 mSv (200 mrem), the individual's personnel dosimeter must be sent for processing within 24 hours. For personnel dosimeters that do not require processing, evaluation of the dosimeter must be started within 24 hours. In addition, the individual may not resume work associated with the use of sources of radiation until a determination of the individual's radiation exposure has been made. This determination must be made by the radiation safety officer or the radiation safety officer's designee. The results of this determination must be included in the records maintained in accordance with 12VAC5-481-1490.

E. If the personnel dosimeter is lost or damaged, the worker shall cease work immediately until a replacement personnel dosimeter meeting the requirements of subsection A of this section is provided and the exposure is calculated for the time period from issuance to loss or damage of the personnel dosimeter. The results of the calculated exposure and the time period for which the personnel dosimeter was lost or damaged must be included in the records maintained in accordance with 12VAC5-481-1490.

F. Dosimetry results must be retained in accordance with 12VAC5-481-1490.

G. Each alarming ratemeter must:

1. Be checked to ensure that the alarm functions properly before using at the start of each shift;

2. Be set to give an alarm signal at a preset dose rate of 5 mSv (500 mrem) per hour with an accuracy of plus or minus 20% of the true radiation dose rate;

3. Require special means to change the preset alarm function; and

4. Be calibrated at periods not to exceed 12 months for correct response to radiation. The licensee shall maintain records of alarming ratemeter calibrations in accordance with 12VAC5-481-1490.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 37, Issue 25, eff. January 14, 2022.

12VAC5-481-1360 Radiation surveys

The licensee or registrant shall:

1. Conduct all surveys with a calibrated and operable radiation survey instrument that meets the requirements of 12VAC5-481-1240;

2. Conduct a survey of the radiographic exposure device and the guide tube after each exposure when approaching the device or the guide tube. The survey must determine that the sealed source has returned to its shielded position before exchanging films, repositioning the exposure head, or dismantling equipment. Radiation machines shall be surveyed after each exposure to determine that the machine is off;

3. Conduct a survey of the radiographic exposure device whenever the source is exchanged and whenever a radiographic exposure device is placed in a storage area, as defined in 12VAC5-481-10, to ensure that the sealed source is in its shielded position; and

4. Maintain records in accordance with 12VAC5-481-1500.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-1370 Surveillance

During each radiographic operation, the radiographer shall ensure continuous direct visual surveillance of the operation to protect against unauthorized entry into a radiation area or a high radiation area, as defined in Part I (12VAC5-481-10 et seq.) of this chapter, except at permanent radiographic installations where all entryways are locked and the requirements of 12VAC5-481-1280 are met.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-1380 Posting

All areas in which industrial radiography is being performed must be conspicuously posted as required by 12VAC5-481-860. The exceptions listed in 12VAC5-481-870 do not apply to industrial radiographic operations.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 3 Recordkeeping Requirements

12VAC5-481-1390 Records for industrial radiography

Article 3 Recordkeeping Requirements

Each licensee or registrant shall maintain a copy of its license or registration, documents incorporated by reference, and amendments to each of these items until superseded by new documents approved by the agency, or until the agency terminates the license or registration.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-1400 Records of receipt and transfer of sources of radiation

A. Each licensee or registrant shall maintain records showing the receipts and transfers of sealed sources, devices using DU for shielding, and radiation machines, and retain each record for three years after it is made.

B. These records must include the date, the name of the individual making the record, radionuclide, number of becquerels (curies) or mass (for DU), and manufacturer, model, and serial number of each source of radiation and/or device, as appropriate.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-1410 Records of radiation survey instruments

Each licensee or registrant shall maintain records of the calibrations of its radiation survey instruments that are required under 12VAC5-481-1240 and retain each record for three years after it is made.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-1420 Records of leak testing of sealed sources and devices containing DU

Each licensee shall maintain records of leak test results for sealed sources and for devices containing DU. The results must be stated in units of becquerels (microcuries). The licensee shall retain each record for three years after it is made or until the source in storage is removed.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1430 Records of quarterly inventory

A. Each licensee or registrant shall maintain records of the quarterly inventory of sources of radiation, including devices containing depleted uranium as required by 12VAC5-481-1260, and retain each record for three years.

B. The record must include the date of the inventory, name of the individual conducting the inventory, radionuclide, number of becquerels (curies) or mass (for DU) in each device, location of sources of radiation and/or devices, and manufacturer, model, and serial number of each source of radiation and/or device, as appropriate.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-1440 Utilization logs

A. Each licensee or registrant shall maintain utilization logs showing for each source of radiation the following information:

1. A description, including the make, model, and serial number of the radiation machine or the radiographic exposure device, transport, or storage container in which the sealed source is located;

2. The identity and signature of the radiographer to whom assigned;

3. The location and dates of use, including the dates removed and returned to storage; and

4. For permanent radiographic installations, the dates each radiation machine is energized.

B. The licensee or registrant shall retain the logs required by subsection A of this section for three years.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1450 Records of inspection and maintenance of radiation machines, radiographic exposure devices, transport and storage containers, associated equipment,...

A. Each licensee or registrant shall maintain records specified in 12VAC5-481-1270 of equipment problems found in daily checks and quarterly inspections of radiation machines, radiographic exposure devices, transport and storage containers, associated equipment, source changers, and survey instruments, and retain each record for three years after it is made.

B. The record must include the date of check or inspection, name of inspector, equipment involved, any problems found, and what repair and/or maintenance, if any, was performed.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-1460 Records of alarm system and entrance control checks at permanent radiographic installations

Each licensee or registrant shall maintain records of alarm system and entrance control tests required by 12VAC5-481-1280 and retain each record for three years after it is made.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-1470 Records of training and certification

Each licensee or registrant shall maintain the following records for three years:

1. Records of training of each radiographer and each radiographer's assistant. The record must include radiographer certification documents and verification of certification status, copies of written tests, dates of oral and practical examinations, the names of individuals conducting and receiving the oral and practical examinations, and a list of items tested and the results of the oral and practical examinations; and

2. Records of annual refresher safety training and semi-annual inspections of job performance for each radiographer and each radiographer's assistant. The records must list the topics discussed during the refresher safety training, the dates the annual refresher safety training was conducted, and names of the instructors and attendees. For inspections of job performance, the records must also include a list showing the items checked and any noncompliance observed by the radiation safety officer or designee.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-1480 Copies of operating and emergency procedures

Each licensee or registrant shall maintain a copy of current operating and emergency procedures until the agency terminates the license or registration. Superseded material must be retained for three years after the change is made.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-1490 Records of personnel monitoring

Each licensee or registrant shall maintain the following exposure records specified in 12VAC5-481-1350:

1. Direct reading dosimeter readings and yearly operability checks required by 12VAC5-481-1350 B and 12VAC5-481-1350 C for three years after the record is made;

2. Records of alarming ratemeter calibrations for three years after the record is made;

3. Personnel dosimeter results until the agency terminates the license or registration; and

4. Records of estimates of exposures as a result of off-scale personal direct reading dosimeters or lost or damaged personnel dosimeters until the agency terminates the license or registration.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 37, Issue 25, eff. January 14, 2022.

12VAC5-481-1500 Records of radiation surveys

Each licensee shall maintain a record of each exposure device survey conducted before the device is placed in storage as specified in subdivision 3 of 12VAC5-481-1360. Each record must be maintained for three years after it is made.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-1510 Form of records

Each record required by this part must be legible throughout the specified retention period. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of reproducing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records, such as letters, drawings, and specifications, must include all pertinent information, such as stamps, initials, and signatures. The licensee or registrant shall maintain adequate safeguards against tampering with and loss of records.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-1520 Location of documents and records

A. Each licensee or registrant shall maintain copies of records required by this part and other applicable parts of these regulations at the location specified in 12VAC5-481-1200 A 11.

B. Each licensee or registrant shall also maintain current copies of the following documents and records sufficient to demonstrate compliance at each applicable field station and each temporary jobsite;

1. The license or registration authorizing the use of sources of radiation;

2. A copy of Parts I (12VAC5-481-10 et seq.); IV (12VAC5-481-600 et seq.); V (12VAC5-481-1170 et seq.); and X (12VAC5-481-2250 et seq.) of this chapter;

3. Utilization logs for each source of radiation dispatched from that location as required by 12VAC5-481-1440.

4. Records of equipment problems identified in daily checks of equipment as required by 12VAC5-481-1450 A;

5. Records of alarm system and entrance control checks required by 12VAC5-481-1460, if applicable;

6. Records of dosimeter readings as required by 12VAC5-481-1490;

7. Operating and emergency procedures as required by 12VAC5-481-1480;

8. Evidence of the latest calibration of the radiation survey instruments in use at the site, as required by 12VAC5-481-1410;

9. Evidence of the latest calibrations of alarming ratemeters and operability checks of dosimeters as required by 12VAC5-481-1490;

10. Survey records as required by 12VAC5-481-1500 and 12VAC5-481-1000 as applicable, for the period of operation at the site;

11. The shipping papers for the transportation of radioactive materials required by Part XIII (12VAC5-481-2950 et seq.) of this chapter; and

12. When operating under reciprocity pursuant to Part III (12VAC5-481-380 et seq.) of this chapter, a copy of the applicable state license or registration, or NRC license authorizing the use of sources of radiation.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 4 Notifications

12VAC5-481-1530 Notifications

Article 4 Notifications

A. In addition to the reporting requirements specified in 12VAC5-481-1110 and in Part IV (12VAC5-481-600 et seq.) of this chapter, each licensee or registrant shall provide a written report to the agency within 30 days of the occurrence of any of the following incidents involving radiographic equipment:

1. Unintentional disconnection of the source assembly from the control cable;

2. Inability to retract the source assembly to its fully shielded position and secure it in this position;

3. Failure of any component, which is critical to safe operation of the device, to properly perform its intended function; or

4. An indicator on a radiation machine fails to show that radiation is being produced, an exposure switch fails to terminate production of radiation when turned to the off position, or a safety interlock fails to terminate X-ray production.

B. The licensee or registrant shall include the following information in each report submitted under subsection A of this section, and in each report of overexposure submitted under 12VAC5-481-1110 that involves failure of safety components of radiography equipment:

1. Description of the equipment problem;

2. Cause of each incident, if known;

3. Name of the manufacturer and model number of equipment involved in the incident;

4. Place, date, and time of the incident;

5. Actions taken to establish normal operations;

6. Corrective actions taken or planned to prevent recurrence; and

7. Names and qualifications of personnel involved in the incident.

C. Any licensee or registrant conducting radiographic operations or storing sources of radiation at any location not listed on the license or registration for a period in excess of 180 days in a calendar year shall notify the agency prior to exceeding the 180 days.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 32, Issue 24, eff. August 25, 2016.

Article 5 Jobsite Requirements

12VAC5-481-1540 (Repealed.)

Article 5 Jobsite Requirements

History

• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; repealed, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1550 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; repealed, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1560 Reciprocity

A. All reciprocal recognition of licenses and registrations by the agency will be granted in accordance with Part III (12VAC5-481-380 et seq.) of this chapter.

B. Reciprocal recognition by the agency of an individual radiographer certification will be granted provided that:

1. The individual holds a valid certification in the appropriate category issued by a certifying entity, as defined in 12VAC5-481-10;

2. The requirements and procedures of the certifying entity issuing the certification affords the same or comparable certification standards as those afforded by 12VAC5-481-1320 A;

3. The applicant presents the certification to the agency prior to entry into the state; and

4. No escalated enforcement action is pending with the NRC or in any other agreement state.

C. Certified individuals who are granted reciprocity by the agency shall maintain the certification upon which the reciprocal recognition was granted, or prior to the expiration of such certification, shall meet the requirements of 12VAC5-481-1320 A.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1570 Specific requirements for radiographic personnel performing industrial radiography

A. At a job site, the following shall be supplied by the licensee or registrant:

1. At least one operable, calibrated survey instrument for each exposure device or radiation machine in use;

2. A current whole body personnel monitor (TLD, OSL or film badge) for each person performing radiographic operations;

3. An operable, calibrated pocket dosimeter with a range of 0 to 2 mSv (200 mrem) for each person performing radiographic operations;

4. An operable, calibrated, alarming ratemeter for each person performing radiographic operations using a radiographic exposure device; and

5. The appropriate barrier ropes and signs.

B. Each radiographer at a job site shall have on their person a valid certification ID card issued by a certifying entity.

C. Industrial radiographic operations shall not be performed if any of the items in subsections A and B of this section are not available at the job site or are inoperable.

D. During an inspection, the agency may terminate an operation if any of the items in subsections A and B of this section are not available or operable, or if the required number of radiographic personnel are not present. Operations shall not be resumed until all required conditions are met.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1580 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; repealed, Virginia Register Volume 31, Issue 24, eff. August 27, 2015.

12VAC5-481-1581 Purpose and scope

This part establishes requirements, for which a registrant is responsible, for use of diagnostic x-ray equipment and imaging systems by or under the supervision of an individual authorized by and licensed in accordance with Virginia law to engage in the healing arts or veterinary medicine. The provisions of this part are in addition to and not in substitution for other applicable provisions of this chapter.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 31, Issue 24, eff. August 27, 2015.

12VAC5-481-1590 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; repealed, Virginia Register Volume 31, Issue 24, eff. August 27, 2015.

12VAC5-481-1591 General and administrative requirements

A. Radiation safety requirements. The registrant shall be responsible for directing the operation of the x-ray system under his administrative control. The registrant or the registrant's agent shall assure that the requirements of this chapter are met in the operation of the x-ray system or systems.

1. An x-ray system that does not meet the provisions of this chapter shall not be operated for diagnostic purposes.

2. Individuals who will be operating the x-ray systems shall meet the qualifications of this part to conduct the practice of radiologic technology.

3. A chart shall be provided in the vicinity of the diagnostic x-ray system's control panel that specifies, for all examinations performed with that system, the following information:

a. Patient's body part and anatomical size, or body part thickness, or age (for pediatrics), versus technique factors to be utilized;

b. Type and size of the image receptor to be used;

c. Type and size of the image receptor combination to be used, if any;

d. Source to image receptor distance to be used (except for dental intraoral radiography);

e. Type and location of placement of patient shielding (e.g., gonad, etc.) to be used; and

f. For mammography, indication of kVp/target/filter combination.

4. The registrant of a facility shall create and make available to x-ray operators written safety procedures, including patient holding and any restrictions of the operating technique required for the safe operation of the particular x-ray system. The operator shall be able to demonstrate familiarity with these procedures.

5. Except for patients who cannot be moved out of the room, only the staff, ancillary personnel, or other persons required for the medical procedure or training shall be in the room during the radiographic exposure. Other than the patient being examined:

a. All individuals shall be positioned such that no part of the body will be struck by the useful beam unless protected by not less than 0.5 mm lead equivalent material;

b. The x-ray operator, other staff, ancillary personnel, and other persons required for the medical procedure shall be protected from the direct scatter radiation by protective aprons or whole body protective barriers of not less than 0.25 mm lead equivalent material. However, when distances provide sufficient protection from scatter radiation, or for low dose rate devices such as bone densitometry equipment, no protective devices may be necessary; and

c. Human patients who cannot be removed from the room shall be protected from the direct scatter radiation by whole body protective barriers of not less than 0.25 mm lead equivalent material or shall be so positioned that the nearest portion of the body is at least two meters from both the tube head and the nearest edge of the image receptor.

6. Gonad shielding of not less than 0.5 mm lead equivalent material shall be used for human patients, who have not passed the reproductive age, during radiographic procedures in which the gonads are in the useful beam, except for cases in which this would interfere with the diagnostic procedure.

7. Individuals shall not be exposed to the useful beam except for healing arts purposes and unless such exposure has been authorized by a licensed practitioner of the healing arts. This provision specifically prohibits deliberate exposure for the following purposes:

a. Exposure of an individual for training, demonstration, or other non-healing arts purposes; and

b. Exposure of an individual for the purpose of healing arts screening except as authorized by subdivision 11 of this subsection.

8. When a patient or image receptor must be provided with auxiliary support during a radiation exposure:

a. Mechanical holding devices shall be used when the technique permits. The written safety procedures, as required by subdivision 4 of this subsection, shall list individual projections where holding devices cannot be utilized;

b. Written safety procedures, as required by subdivision 4 of this subsection, shall indicate the requirements for selecting a holder and the procedure the holder shall follow;

c. The human holder shall be instructed in personal radiation safety and protected as required by subdivision 5 of this subsection. Caregivers who stay in the room to assist with imaging of patients shall be positioned and instructed to keep the protective apron between themselves and the patient;

d. No individual shall be used routinely to hold image receptors or patients;

e. In those cases where the patient must hold the image receptor, except during intraoral examinations, any portion of the body other than the area of clinical interest struck by the useful beam shall be protected by not less than 0.5 mm lead equivalent material; and

f. Each facility shall have leaded aprons and gloves available in sufficient numbers to provide protection for all personnel who are involved with x-ray operations and who are otherwise not shielded.

9. Procedures and auxiliary equipment designed to minimize patient and personnel exposure commensurate with the needed diagnostic information shall be utilized.

a. The fastest imaging system consistent with the diagnostic objective of the examinations shall be used. Film cassettes without intensifying screens shall not be used for any routine diagnostic radiological imaging, with the exception of veterinary radiography and standard film packets for intraoral use in dental radiography.

b. The radiation exposure to the patient shall be the minimum exposure required to produce images of good diagnostic quality.

c. Portable or mobile radiographic (exclude fluoroscopic) x-ray equipment shall be used only for examinations where it is impractical to transfer the patient to a stationary x-ray installation.

d. X-ray systems subject to 12VAC5-481-1621 shall not be utilized in procedures where the source to patient distance is less than 30 cm, except for veterinary systems.

e. If grids are used between the patient and the image receptor to decrease scatter to the film and improve contrast, the grid shall:

(1) Be positioned properly, that is, tube side facing the right direction, and grid centered to the central ray; and

(2) If the grid is of the focused type, be of the proper focal distance for the SIDs being used.

10. All individuals who are associated with the operation of an x-ray system are subject to the requirements of 12VAC5-481-640, 12VAC5-481-700, and 12VAC5-481-710.

11. Any person proposing to conduct a healing arts screening program shall not initiate such a program without prior approval of the agency. If any information submitted to the agency becomes invalid or outdated, the agency shall be immediately notified. Persons requesting that the agency approve a healing arts screening program shall submit the following information and evaluation:

a. Name and address of the applicant and, where applicable, the names and addresses of agents within this state;

b. Diseases or conditions for which the x-ray examinations are to be used in diagnoses;

c. A description of the x-ray examinations proposed in the screening program, that is, type and number of views;

d. Description of the population to be examined in the screening program, that is, age range, sex, physical condition, and other appropriate information;

e. An evaluation of any known alternate methods not involving ionizing radiation that could achieve the goals of the screening program and why these methods are not used instead of the x-ray examinations;

f. An evaluation by a qualified medical physicist of the x-ray system or systems to be used in the screening program. The evaluation shall include the following:

(1) Documentation that such systems satisfy all requirements of this chapter; and

(2) Measurement of patient exposures from the x-ray examinations to be performed;

g. A description of the diagnostic x-ray quality control program;

h. A copy of the technique chart for the x-ray examination procedures to be used;

i. The qualifications of each individual who will be operating the x-ray system or systems;

j. The qualifications of the individual who will be supervising the operators of the x-ray system or systems. The extent of supervision and the method of work performance evaluation shall be specified;

k. The name and address of the practitioner licensed in the state who will interpret the radiograph;

l. Procedures to be used in advising the individuals screened and their practitioners of the healing arts or health care providers of the results of the screening procedure and any further medical needs indicated;

m. Procedures for the retention or disposition of the radiographs and other records pertaining to the x-ray examinations;

n. Frequency of screening of individuals; and

o. The duration of the screening program.

12. The registrant shall maintain the following information and maintenance record for each x-ray system for inspection by the agency:

a. Model and serial numbers of all major components, and user's manuals for those components;

b. Tube rating charts and cooling curves;

c. Records of surveys, calibrations, maintenance, and modifications performed on the x-ray system or systems; and

d. A copy of all correspondence with the agency regarding that x-ray system.

13. Except for veterinary facilities, each facility shall maintain an x-ray utilization log containing the patient's name, the type of examination, and the date the examination was performed.

14. The registrant shall maintain a list of x-ray operators for each facility. Operators must be licensed by the Department of Health Professions where x-rays are used within the scope of practice or be certified by the American Registry of Radiological Technologists (ARRT), or be an individual enrolled, or was enrolled within the past three months, in an accredited program for radiologic technology and under the supervision of a licensed or certified radiological technologist, or if a dental assistant, comply with the Board of Dentistry's radiation certification requirements in 18VAC60-20-195.

B. X-ray film processing facilities and practices.

1. Each installation using a radiographic x-ray system and analog image receptors (e.g., radiographic film) shall have available suitable equipment for handling and processing radiographic film in accordance with the following provisions:

a. Manually developed film.

(1) Processing tanks shall be constructed of mechanically rigid, corrosion resistant material; and

(2) The temperature of solutions in the tanks shall be maintained within the range of 60°F to 80°F (16°C to 27°C). Film shall be developed in accordance with the time-temperature relationships recommended by the film manufacturer or, in the absence of such recommendations, with the following time-temperature chart:

| | Time-Temperature Chart | | | | --- | --- | --- | --- | | | Thermometer Reading (Degrees) | Minimum Developing Time (Minutes) | | | | °C | °F | | | | 26.7 | 80 | 2 | | | 26.1 | 79 | 2 | | | 25.6 | 78 | 2-1/2 | | | 25.0 | 77 | 2-1/2 | | | 24.4 | 76 | 3 | | | 23.9 | 75 | 3 | | | 23.3 | 74 | 3-1/2 | | | 22.8 | 73 | 3-1/2 | | | 22.2 | 72 | 4 | | | 21.7 | 71 | 4 | | | 21.1 | 70 | 4-1/2 | | | 20.6 | 69 | 4-1/2 | | | 20.0 | 68 | 5 | | | 19.4 | 67 | 5-1/2 | | | 18.9 | 66 | 5-1/2 | | | 18.3 | 65 | 6 | | | 17.8 | 64 | 6-1/2 | | | 17.2 | 63 | 7 | | | 16.7 | 62 | 8 | | | 16.1 | 61 | 8-1/2 | | | 15.6 | 60 | 9-1/2 |

(3) Devices shall be utilized that will indicate the actual temperature of the developer and signal the passage of a preset time appropriate to the developing time required.

b. Automatic processors and other closed processing systems. Films shall be developed in accordance with the time-temperature relationships recommended by the film manufacturer. In the absence of such recommendations, the film shall be developed using the following chart:

| | Developer Temperature | Minimum Immersion Time* | | | --- | --- | --- | --- | | | °C | °F | Seconds | | | 35.5 | 96 | 19 | | | 35 | 95 | 20 | | | 34.5 | 94 | 21 | | | 34 | 93 | 22 | | | 33.5 | 92 | 23 | | | 33 | 91 | 24 | | | 32 | 90 | 25 | | | 31.5 | 89 | 26 | | | 31 | 88 | 27 | | | 30.5 | 87 | 28 | | | 30 | 86 | 29 | | | 29.5 | 85 | 30 | | | *Immersion time only, no crossover time included. | | |

Processing deviations from the requirements of this subdivision shall be documented by the registrant in such manner that the requirements are shown to be met or exceeded (e.g., extended processing and special rapid chemistry).

2. Other requirements.

a. Pass boxes, if provided, shall be so constructed as to exclude light from the darkroom when cassettes are placed in or removed from the boxes and shall incorporate adequate shielding from stray radiation to prevent exposure of undeveloped film.

b. The darkroom shall be light tight and use proper safelighting such that any film type in use exposed in a cassette to x-ray radiation sufficient to produce an optical density from one to two when processed shall not suffer an increase in density greater than 0.1 (0.05 for mammography) when exposed in the darkroom for two minutes with all safelights on. If used, daylight film handling boxes shall preclude fogging of the film.

c. Darkrooms typically used by more than one individual shall be provided a method to prevent accidental entry while undeveloped films are being handled or processed.

d. Film shall be stored in a cool, dry place and shall be protected from exposure to stray radiation. Film in open packages shall be stored in a light tight container.

e. Film cassettes and intensifying screens shall be inspected periodically and shall be cleaned and replaced as necessary to best assure radiographs of good diagnostic quality.

f. Outdated x-ray film shall not be used for diagnostic radiographs, unless the film has been stored in accordance with the manufacturer's recommendations and a sample of the film passes a sensitometric test for normal ranges of base plus fog and speed.

g. Film developing solutions shall be prepared in accordance with the directions given by the manufacturer and shall be maintained in strength by replenishment or renewal so that full development is accomplished within the time specified by the manufacturer.

h. Living and deceased patients' diagnostic images shall be maintained for a minimum of five years. Diagnostic images for minors shall be maintained for a minimum of five years beyond their 18th birthday.

C. The registrant shall submit to the agency a copy of all surveys, calibrations, and inspections performed by a private inspector within 30 days of completion of the survey, calibration, or inspection.

D. The private inspector shall provide the inspection report to the registrant within 14 days of the completion of the inspection. A summary or recommendation shall be included with this report. The inspector shall notify the registrant of any noncompliances that need corrective action.

E. Violations identified as "serious" must be corrected within 30 days. Certification of the unit will not be issued until the violation is corrected. Violations identified as "non-serious" shall be corrected before the next inspection cycle. Uncorrected "non-serious" violations will become "serious" and require immediate correction.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 31, Issue 24, eff. August 27, 2015.

12VAC5-481-1600 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; repealed, Virginia Register Volume 31, Issue 24, eff. August 27, 2015.

12VAC5-481-1601 General requirements for all diagnostic x-ray systems

In addition to other requirements of this part, all diagnostic x-ray systems shall meet the following requirements:

1. Warning label. The control panel containing the main power switch shall bear the warning statement, legible and accessible to view:

"WARNING: This x-ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions, and maintenance schedules are observed."

2. Leakage radiation from the diagnostic source assembly. The leakage radiation from the diagnostic source assembly measured at a distance of one meter in any direction from the source shall not exceed 0.88 milligray (mGy) air kerma (100 milliroentgen (mR) exposure) in one hour when the x-ray tube is operated at its leakage technique factors. If the maximum rated peak tube potential of the tube housing assembly is greater than the maximum rated peak tube potential for the diagnostic source assembly, positive means shall be provided to limit the maximum x-ray tube potential to that of the diagnostic source assembly. Compliance shall be determined by measurements averaged over an area of 100 square cm with no linear dimension greater than 20 cm.

3. Radiation from components other than the diagnostic source assembly. The radiation emitted by a component other than the diagnostic source assembly shall not exceed an air kerma of 18 microgray (two milliroentgens exposure) in one hour at five cm from any accessible surface of the component when it is operated in an assembled x-ray system under any conditions for which it was designed. Compliance shall be determined by measurements averaged over an area of 100 square cm with no linear dimension greater than 20 cm.

4. Beam quality half-value layer (HVL).

a. The HVL of the useful beam for a given x-ray tube potential shall not be less than the values shown in Table 1 (i)under the heading "Specified Dental Systems" for any dental x-ray system designed for use with intraoral image receptors and manufactured after December 1, 1980; (ii)under the heading "I-Other X-Ray Systems" for any dental x-ray system designed for use with intraoral image receptors and manufactured before or on December 1, 1980, and all other x-ray systems subject to this section and manufactured before June 10, 2006; and (iii)under the heading "II-Other X-Ray Systems" for all x-ray systems, except dental x-ray systems designed for use with intraoral image receptors, subject to this section and manufactured on or after June 10, 2006. If it is necessary to determine such half-value layer at an x-ray tube potential that is not listed in Table 1, linear interpolation or extrapolation may be made. Positive means shall be provided to ensure that at least the minimum filtration needed to achieve beam quality requirements is in the useful beam during each exposure. In the case of a system, which is to be operated with more than one thickness of filtration, this requirement can be met by a filter interlocked with the kilovoltage selector that will prevent x-ray emissions if the minimum required filtration is not in place.

| | TABLE 1 | | | | | | --- | --- | --- | --- | --- | --- | | | X-Ray Tube Voltage (kilovolt peak) | | | | | | | Design Operating Range | Measured Operating Potential | Minimum HVL (mm in Aluminum) | | | | | Specified Dental Systems¹ | I-Other X-Ray Systems² | II-Other X-Ray Systems³ | | | | | Below 51 | 30 | 1.5 | 0.3 | 0.3 | | | | 40 | 1.5 | 0.4 | 0.4 | | | | 50 | 1.5 | 0.5 | 0.5 | | | 51 to 70 | 51 | 1.5 | 1.2 | 1.3 | | | | 60 | 1.5 | 1.3 | 1.5 | | | | 70 | 1.5 | 1.5 | 1.8 | | | Above 70 | 71 | 2.1 | 2.1 | 2.5 | | | | 80 | 2.3 | 2.3 | 2.9 | | | | 90 | 2.5 | 2.5 | 3.2 | | | | 100 | 2.7 | 2.7 | 3.6 | | | | 110 | 3.0 | 3.0 | 3.9 | | | | 120 | 3.2 | 3.2 | 4.3 | | | | 130 | 3.5 | 3.5 | 4.7 | | | | 140 | 3.8 | 3.8 | 5.0 | | | | 150 | 4.1 | 4.1 | 5.4 | | | ¹ Dental x-ray systems designed for use with intraoral image receptors and manufactured after December 1, 1980. ² Dental x-ray systems designed for use with intraoral image receptors and manufactured before or on December 1, 1980, and all other x-ray systems subject to this section and manufactured before June 10, 2006. ³ All x-ray systems, except dental x-ray systems designed for use with intraoral image receptors, subject to this section and manufactured on or after June 10, 2006. | | | | |

b. Optional filtration. Fluoroscopic systems manufactured on or after June 10, 2006, incorporating an x-ray tube or tubes with a continuous output of one kilowatt or more and an anode heat storage capacity of one million heat units or more shall provide the option of adding x-ray filtration to the diagnostic source assembly in addition to the amount needed to meet the half-value layer provisions in Table 1. The selection of this additional x-ray filtration shall be either at the option of the user or automatic as part of the selected mode of operation. A means of indicating which combination of additional filtration is in the x-ray beam shall be provided.

c. Measuring compliance. For capacitor energy storage equipment, compliance shall be determined with the maximum selectable quantity of charge per exposure.

5. Aluminum equivalent of material between patient and image receptor. Except when used in a CT x-ray system, the aluminum equivalent of each of the items listed in Table 2, which are used between the patient and the image receptor, shall not exceed the indicated limits. Compliance shall be determined by x-ray measurements made at a potential of 100 kilovolts peak and with an x-ray beam that has an HVL specified in Table 1 for the potential. This requirement applies to front panel or panels of cassette holders and film changers provided by the manufacturer for patient support or for prevention of foreign object intrusions. It does not apply to screens and their associated mechanical support panels or grids.

| | TABLE 2 | | | --- | --- | --- | | | Item | Maximum Aluminum Equivalent (mm) | | | Front panel(s) of cassette holders (total of all) | 1.2 | | | Film panel(s) of film changer (total of all) | 1.2 | | | Cradle | 2.3 | | | Tabletop, stationary, without articulated joints | 1.2 | | | Tabletop, movable, without articulated joints (including stationary subtop) | 1.7 | | | Tabletop, with radiolucent panel having one articulated joint | 1.7 | | | Tabletop, with radiolucent panel having two or more articulated joints | 2.3 | | | Tabletop, cantilevered | 2.3 | | | Tabletop, radiation therapy simulator | 5.0 |

6. Battery charge indicator. On battery-powered generators, visual means shall be provided on the control panel to indicate whether the battery is in a state of charge adequate for proper operation.

7. Modification of certified diagnostic x-ray components and systems.

a. Diagnostic x-ray components and systems certified in accordance with 21 CFR Part 1020 shall not be modified such that the component or system fails to comply with any applicable provision of this part.

b. The owner of a diagnostic x-ray system who uses the system in a professional or commercial capacity may modify the system provided the modification does not result in the failure of the system or a component to comply with the applicable requirements of this part. The owner who causes such modification need not submit the reports required by this part, provided the owner records the date and the details of the modification in the system records and maintains this information, and provided the modification of the x-ray system does not result in a failure to comply with this part.

8. Multiple tubes. Where two or more radiographic tubes are controlled by one exposure switch, the tube or tubes that have been selected shall be clearly indicated prior to initiation of the exposure. This indication shall be both on the x-ray control panel and at or near the tube housing assembly which has been selected.

9. Mechanical support of tube head. The tube housing assembly supports shall be adjusted such that the tube housing assembly will remain stable during an exposure unless tube housing movement is a designed function of the x-ray system.

10. Technique indicators.

a. For x-ray equipment capable of displaying technique factors, the technique factors to be used during an exposure shall be indicated before the exposure begins. If automatic exposure controls are used, the technique factors that are set prior to the exposure shall be indicated.

b. The requirement of subdivision 10 a of this subsection may be met by permanent markings on equipment having fixed technique factors. Indication of technique factors shall be visible from the operator's position except in the case of spot films made by the fluoroscopist.

11. Maintaining compliance. Diagnostic x-ray systems and their associated components used on humans and certified pursuant to the Federal X-Ray Equipment Performance Standard (21 CFR Part 1020) shall be maintained in compliance with applicable requirements of that standard.

12. Locks. All position locking, holding, and centering devices on x-ray system components and systems shall function as intended.

13. Mechanical timers. The use of mechanical timers is prohibited.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 31, Issue 24, eff. August 27, 2015.

12VAC5-481-1610 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; repealed, Virginia Register Volume 31, Issue 24, eff. August 27, 2015.

12VAC5-481-1611 Fluoroscopic equipment

A. The provisions of this sectionapply to equipment for fluoroscopic imaging or for recording images from the fluoroscopic image receptor, except computed tomography x-ray systems manufactured on or after November 29, 1984.

B. Primary protective barrier.

1. Limitation of useful beam. The fluoroscopic imaging assembly shall be provided with a primary protective barrier that intercepts the entire cross section of the useful beam at any SID. The x-ray tube used for fluoroscopy shall not produce x-rays unless the barrier is in position to intercept the entire useful beam. The AKR due to transmission through the barrier with the attenuation block in the useful beam combined with radiation from the fluoroscopic imaging receptor shall not exceed 3.34x10^-3% of the entrance AKR, at a distance of 10 cm from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the image receptor. Radiation therapy simulation systems shall be exempt from this requirement provided the systems are intended only for remote control operation.

2. Measuring compliance. The AKR shall be measured in accordance with subsection E of this section. The AKR due to transmission through the primary barrier combined with radiation from the fluoroscopic image receptor shall be determined by measurements averaged over an area of 100 square cm with no linear dimension greater than 20 cm. If the source is below the tabletop, the measurement shall be made with the input surface of the fluoroscopic imaging assembly positioned 30 cm above the tabletop. If the source is above the tabletop and the SID is variable, the measurement shall be made with the end of the beam-limiting device or spacer as close to the tabletop as it can be placed, provided that it shall not be closer than 30 cm. Movable grids and compression devices shall be removed from the useful beam during the measurement. For all measurements, the attenuation block shall be positioned in the useful beam 10 cm from the point of measurement of entrance AKR and between this point and the input surface of the fluoroscopic imaging assembly.

C. Field limitation.

1. Angulation. For fluoroscopic equipment manufactured after February 25, 1978, when the angle between the image receptor and the beam axis of the x-ray beam is variable, means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor. Compliance with subdivisions 4 and 5 of this subsection shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.

2. Further means for limitation. Means shall be provided to permit further limitation of the x-ray field to sizes smaller than the limits of subdivisions 4 and 5 of this subsection. Beam-limiting devices manufactured after May 22, 1979, and incorporated in equipment with a variable SID or capability of a visible area of greater than 300 square cm, shall be provided with means for stepless adjustment of the x-ray field. Equipment with a fixed SID and the capability of a visible area of no greater than 300 square cm shall be provided with either stepless adjustment of the x-ray field or with a means to further limit the x-ray field size at the plane of the image receptor to 125 square cm or less. Stepless adjustment shall, at the greatest SID, provide continuous field sizes from the maximum obtainable to a field size containable in a square of five cm by five cm. This paragraph does not apply to non-image-intensified fluoroscopy.

3. Non-image-intensified fluoroscopy. The x-ray field produced by non-image-intensified fluoroscopic equipment shall not extend beyond the entire visible area of the image receptor. Means shall be provided for stepless adjustment of field size. The minimum field size, at the greatest SID, shall be containable in a square of five cm by five cm.

4. Fluoroscopy and radiography using the fluoroscopic imaging assembly with inherently circular image receptors.

a. For fluoroscopic equipment manufactured before June 10, 2006, other than radiation therapy simulation systems, the following applies:

(1) Neither the length nor width of the x-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than 3.0% of the SID. The sum of the excess length and the excess width shall be no greater than 4.0% of the SID.

(2) For rectangular x-ray fields used with circular image receptors, the error in alignment shall be determined along the length and width dimensions of the x-ray field that pass through the center of the visible area of the image receptor.

b. For fluoroscopic equipment manufactured on or after June 10, 2006, other than radiation simulation systems, the maximum area of the x-ray field in the plane of the image receptor shall conform with one of the following requirements:

(1) When any linear dimension of the visible area of the image receptor measured through the center of the visible area is less than or equal to 34 cm in any direction, at least 80% of the area of the x-ray field overlaps the visible area of the image receptor; or

(2) When any linear dimension of the visible area of the image receptor measured through the center of the visible area is greater than 34 cm in any direction, the x-ray field measured along the direction of greatest misalignment with the visible area of the image receptor does not extend beyond the edge of the visible area of the image receptor by more than two cm.

5. Fluoroscopy and radiography using fluoroscopic imaging assembly with inherently rectangular image receptors. For x-ray systems manufactured on or after June 10, 2006, the following applies:

a. Neither the length nor width of the x-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than 3.0% of the SID. The sum of the excess length and the excess width shall be no greater than 4.0% of the SID.

b. The error in alignment shall be determined along the length and width dimensions of the x-ray field that pass through the center of the visible area of the image receptor.

If the fluoroscopic x-ray field size is adjusted automatically as the SID or image receptor size is changed, a capability may be provided for overriding the automatic adjustment in case of system failure. If it is so provided, a signal visible at the fluoroscopist's position shall indicate whenever the automatic field adjustment is overridden. Each such system failure override switch shall be clearly labeled as follows:

"For X-Ray Field Limitation System Failure"

D. Activation of tube. X-ray production in the fluoroscopic mode shall be controlled by a device that requires continuous pressure by the operator for the entire time of any exposure. When recording serial radiographic images from the fluoroscopic image receptor, the operator shall be able to terminate the x-ray exposure or exposures at any time, but means may be provided to permit completion of any single exposure of the series in process.

E. Air kerma rates. For fluoroscopic equipment, the following requirements apply:

1. Fluoroscopic equipment manufactured before May 19, 1995.

a. Equipment provided with automatic exposure rate control (AERC) shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (10 R/min exposure rate) at the measurement point specified in subdivision 3 of this subsection, except as specified in subdivision 1 e of this subsection.

b. Equipment provided without AERC shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 44 mGy per minute (5 R/min exposure rate) at the measurement point specified in subdivision 3 of this subsection, except as specified in subdivision 1 e of this subsection.

c. Equipment provided with both an AERC mode and a manual mode shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (10 R/min exposure rate) in either mode at the measurement point specified in subdivision 3 of this subsection, except as specified in subdivision 1 e of this subsection.

d. Equipment may be modified in accordance with this partto comply with subdivision 2 of this subsection. When the equipment is modified, it shall bear a label indicating the date of the modification and the statement:

"Modified to comply with 21 CFR 1020.32(h)(2)"

e. Exceptions:

(1) During recording of fluoroscopic images; or

(2) When a mode of operation has an optional high-level control, in which case that mode shall not be operable at any combination of tube potential and current that will result in an AKR in excess of any of the rates specified in subdivisions 1 a, b, and c of this subsectionat the measurement point specified in subdivision 3 of this subsection, unless the high-level control is activated. Special means of activation of high-level controls shall be required. The high-level control shall be operable only when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high-level control is being employed.

2. Fluoroscopic equipment manufactured on or after May 19, 1995.

a. Equipment shall be equipped with AERC if operable at any combination of tube potential and current that results in an AKR greater than 44 mGy per minute (5 R/min exposure rate) at the measurement point specified in subdivision 3 of this subsection. Provision or manual selection of technique factors may be provided.

b. Equipment shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (10 R/min exposure rate) at the measurement point specified in subdivision 3 of this subsection, except as specified in subdivision 2 c of this subsection.

c. Exceptions:

(1) For equipment manufactured prior to June 10, 2006, during the recording of images from the fluoroscopic image receptor using photographic film or a video camera when the x-ray source is operated in a pulsed mode.

(2) For equipment manufactured on or after June 10, 2006, during the recording of images from the fluoroscopic image receptor for the purpose of providing the user with a recorded image or images after termination of the exposure. Such recording does not include images resulting from a last-image-hold feature that are not recorded.

(3) When a mode of operation has an optional high-level control and the control is activated, in which case the equipment shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 176 mGy per minute (20 R/min exposure rate) at the measurement point specified in subdivision 3 of this subsection. Special means of activation of high-level controls shall be required. The high-level control shall be operable only when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high-level control is employed.

3. Measuring compliance. Compliance with this subsection shall be determined as follows:

a. If the source is below the x-ray table, the AKR shall be measured at one cm above the tabletop or cradle.

b. If the source is above the x-ray table, the AKR shall be measured at 30 cm above the tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement.

c. In a C-arm type of fluoroscope, the AKR shall be measured at 30 cm from the input surface of the fluoroscopic imaging assembly, with the source positioned at any available SID, provided that the end of the beam-limiting device or spacer is no closer than 30 cm from the input surface of the fluoroscopic imaging assembly.

d. In a C-arm type of fluoroscope having an SID less than 45 cm, the AKR shall be measured at the minimum SSD.

e. In a lateral type of fluoroscope, the air kerma rate shall be measured at a point 15 cm from the centerline of the x-ray table and in the direction of the x-ray source with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. If the tabletop is movable, it shall be positioned as closely as possible to the lateral x-ray source, with the end of the beam-limiting device or spacer no closer than 15 cm to the centerline of the x-ray table.

4. Exemptions. Fluoroscopic radiation therapy simulation systems are exempt from the requirements set forth in this subsection when used for therapy simulation purposes.

F. (Reserved.)

G. Indication of potential and current. During fluoroscopy and cinefluorography, x-ray tube potential and current shall be continuously indicated. Deviation of x-ray tube potential and current from the indicated value shall not exceed the maximum deviation as stated by the manufacturer.

H. Source-skin distance.

1. Means shall be provided to limit the source-skin distance to not less than 38 cm on stationary fluoroscopes and to not less than 30 cm on mobile and portable fluoroscopes. In addition, for fluoroscopes intended for specific surgical application that would be prohibited at the source-skin distances specified in this subsection, provisions may be made for operating at shorter source-skin distances but in no case less than 20 cm.

2. For stationary, mobile, or portable C-arm fluoroscopic systems manufactured on or after June 10, 2006, having a maximum source-image receptor distance of less than 45 cm, means shall be provided to limit the source-skin distance to not less than 19 cm. Such systems shall be labeled for extremity use only. In addition, for those systems intended for specific surgical application that would be prohibited at the source-skin distance specified in this subsection, provisions may be made for operation at shorter source-skin distances but in no case less than 10 cm.

I. Fluoroscopic irradiation time, display, and signal.

1. Fluoroscopic equipment manufactured before June 10, 2006.

a. Equipment shall be provided with means to preset the cumulative irradiation time of the fluoroscopic tube. The maximum cumulative time of the timing device shall not exceed five minutes without resetting. A signal audible to the fluoroscopist shall indicate the completion of any preset cumulative irradiation time. Such signal shall continue to sound while x-rays are produced until the timing device is reset. Fluoroscopic equipment may be modified in accordance with 21 CFR 1020.30(q) to comply with the requirements of this subdivision. When the equipment is modified, it shall bear a label indicating the statement:

"Modified to comply with 21 CFR 1020.32(h)(2)"

b. As an alternative to the requirements of this subsection, radiation therapy simulation systems may be provided with a means to indicate the total cumulative exposure time during which x-rays were produced, and which is capable of being reset between x-ray examinations.

2. For x-ray controls manufactured on or after June 10, 2006, there shall be provided for each fluoroscopic tube:

a. A display of the fluoroscopic irradiation time at the fluoroscopist's working position. This display shall function independently of the audible signal described in this subsection. The following requirements apply:

(1) When the x-ray tube is activated, the fluoroscopic irradiation time in minutes and tenths of minutes shall be continuously displayed and updated at least once every six seconds.

(2) The fluoroscopic irradiation time shall also be displayed within six seconds of termination of an exposure and remain displayed until reset.

(3) Means shall be provided to reset the display to zero prior to the beginning of a new examination or procedure.

b. A signal audible to the fluoroscopist shall sound for each passage of five minutes of fluoroscopic irradiation time during an examination or procedure. The signal shall sound until manually reset or, if automatically reset, for at least two seconds.

J. Mobile and portable fluoroscopes. In addition to the other requirements of this subsection, mobile and portable fluoroscopes shall provide an image receptor incorporating more than a simple fluorescent screen.

K. Display of last-image-hold (LIH). Fluoroscopic equipment manufactured on or after June 10, 2006, shall be equipped with means to display LIH image following termination of the fluoroscopic exposure.

1. For an LIH image obtained by retaining pretermination fluoroscopic images, if the number of images and method of combining images are selectable by the user, the selection shall be indicated prior to initiation of the fluoroscopic exposure.

2. For an LIH image obtained by initiating a separate radiographic-like exposure at the termination of fluoroscopic imaging, the technique factors for the LIH image shall be selectable prior to the fluoroscopic exposure, and the combination selected shall be indicated prior to initiation of the fluoroscopic exposure.

3. Means shall be provided to clearly indicate to the user whether a displayed image is the LIH radiograph or fluoroscopy. Display of the LIH radiograph shall be replaced by the fluoroscopic image concurrently with re-initiation of fluoroscopic exposure, unless separate displays are provided for the LIH radiograph and fluoroscopic images.

L. Displays of values of AKR and cumulative air kerma. Fluoroscopic equipment manufactured on or after June 10, 2006, shall display at the fluoroscopist's working position the AKR and cumulative air kerma. The following requirements apply for each x-ray tube used during an examination or procedure:

1. When the x-ray tube is activated and the number of images produced per unit time is greater than six images per second, the AKR in mGy/min shall be continuously displayed and updated at least once every second.

2. The cumulative air kerma in units of mGy shall be displayed either within five seconds of termination of an exposure or displayed continuously and updated at least once every five seconds.

3. The display of the AKR shall be clearly distinguishable from the display of the cumulative air kerma.

4. The AKR and cumulative air kerma shall represent the value for conditions of free-in-air irradiation at one of the following reference locations specified according to the type of fluoroscope.

a. For fluoroscopes with x-ray source below the x-ray table, x-ray source above the table, or of lateral type, the reference location shall be the respective locations specified in subdivision E 3 a or E 3 e of this section.

b. For C-arm fluoroscopes, the reference location shall be 15 cm from the isocenter toward the x-ray source along the beam axis. Alternatively, the reference location shall be at a point specified by the manufacturer to represent the location of the intersection of the x-ray beam with the patient's skin.

5. Means shall be provided to reset to zero the display of cumulative air kerma prior to the commencement of a new examination or procedure.

6. The displayed AKR and cumulative air kerma shall not deviate from the actual values by more than ±35% over the range of six mGy/min and 100 mGy to the maximum indication of AKR and cumulative air kerma, respectively. Compliance shall be determined with an irradiation time greater than three seconds.

M. Control of scattered radiation.

1. Fluoroscopic table designs when combined with procedures utilized shall be such that no unprotected part of any staff or ancillary individual's body shall be exposed to unattenuated scattered radiation that originates from under the table. The attenuation required shall be not less than 0.25 mm lead equivalent.

2. Equipment configuration when combined with procedures shall be such that no portion of any staff or ancillary individual's body, except the extremities, shall be exposed to the unattenuated scattered radiation emanating from above the tabletop unless that individual:

a. Is at least 120 centimeters from the center of the useful beam; or

b. The radiation has passed through not less than 0.25 mm lead equivalent material including, but not limited to, drapes, Bucky-slot cover panel, or self-supporting curtains, in addition to any lead equivalency provided by the protective apron referred to in 12VAC5-481-1591 A 5.

3. The agency may grant exemptions to subdivision 2 of this subsection where a sterile field will not permit the use of the normal protective barriers. Where the use of prefitted sterilized covers for the barriers is practical, the agency shall not permit such exemption.

N. Operator qualifications. The facility shall ensure that only a licensed practitioner of the healing arts or a radiologic technologist or equivalent be allowed to operate fluoroscopic x-ray systems.

O. Equipment operation.

1. All imaging formed by the use of fluoroscopic x-ray systems shall be viewed, directly or indirectly, and interpreted by a licensed practitioner of the healing arts.

2. The operation of fluoroscopic x-ray systems by radiologic technologists or equivalent shall be performed under the direct supervision of a licensed practitioner of the healing arts.

3. Radiologic technology students shall not be allowed to operate fluoroscopic x-ray systems unless directly supervised by a licensed practitioner of the healing arts or radiologic technologist as specified in subsection N of this section.

4. Overhead fluoroscopy shall not be used as a positioning tool for general purpose radiographic examinations.

5. Facilities shall maintain a record of the cumulative fluoroscopic exposure time used and the number of fluorographic images recorded for each examination. This record shall include patient identification, type and date of examination, the fluoroscopic system used, and operator's name.

P. Surveys. Radiation safety and equipment performance surveys shall be performed annually on all fluoroscopic x-ray systems by or under the direct supervision of a private or state inspector who is physically present at the facility during the inspection in order to assure compliance with these regulations.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 31, Issue 24, eff. August 27, 2015.

12VAC5-481-1620 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; repealed, Virginia Register Volume 31, Issue 24, eff. August 27, 2015.

12VAC5-481-1621 Radiographic equipment

A. Control and indication of technique factors.

1. Visual indication. The technique factors to be used during an exposure shall be indicated before the exposure begins, except when automatic exposure controls are used, in which case the technique factors that are set prior to the exposure shall be indicated. On equipment having fixed technique factors, this requirement may be met by permanent markings. Indication of technique factors shall be visible from the operator's position except in the case of spot films made by the fluoroscopist.

2. Timers. Means shall be provided to terminate the exposure at a preset time interval, a preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor.

a. Except during serial radiography, the operator shall be able to terminate the exposure at any time during an exposure of greater than one-half second. Except during panoramic dental radiography, termination of exposure shall cause automatic resetting of the timer to its initial setting or to zero. It shall not be possible to make an exposure when the timer is set to a zero or off position if either position is provided.

b. During serial radiography, the operator shall be able to terminate the x-ray exposure at any time, but means may be provided to permit completion of any single exposure of the series in process.

3. Automatic exposure controls. When an automatic exposure control is provided:

a. Indication shall be made on the control panel when this mode of operation is selected;

b. When the x-ray tube potential is equal to or greater than 51 kilovolts peak (kVp), the minimum exposure time for field emission equipment rated for pulse operation shall be equal to or less than a time interval equivalent to two pulses and the minimum exposure time for all other equipment shall be equal to or less than 1/60 second or a time interval required to deliver five milliampere-seconds (mAs), whichever is greater;

c. Either the product of peak x-ray tube potential, current, and exposure time shall be limited to not more than 60 kilowatt-seconds (kWs) per exposure or the product of x-ray tube current and exposure time shall be limited to not more than 600 mAs per exposure, except when the x-ray tube potential is less than 51 kVp, in which case the product of x-ray tube current and exposure time shall be limited to not more than 2,000 mAs per exposure; and

d. A visible signal shall indicate when an exposure has been terminated at the limits described in subdivision 3 c of this subsection, and manual resetting shall be required before further automatically timed exposures can be made.

4. Accuracy. Deviation of technique factors from indicated values shall not exceed the limits given by the manufacturer. In the absence of manufacturer's limits, the deviation shall not exceed 10% of the indicated value for kVp and time.

B. Reproducibility. The following requirements shall apply when the equipment is operated on an adequate power supply as specified by the manufacturer:

1. Coefficient of variation. For any specific combination of selected technique factors, the estimated coefficient of variation of the air kerma shall be no greater than 0.10.

2. Measuring compliance. Determination of compliance shall be based on four consecutive measurements taken within a time period of one hour. Equipment manufactured after September 5, 1978, shall be subject to the additional requirement that all variable controls for technique factors shall be adjusted to alternate settings and reset to the test setting after each measurement. The percent line-voltage regulation shall be within ±1 of the mean value for all measurements. For equipment having automatic exposure controls, compliance shall be determined with a sufficient thickness of attenuating material in the useful beam such that the technique factors can be adjusted to provide individual exposures of a minimum of 12 pulses on field emission equipment rated for pulsed operation or no less than one-tenth second per exposure on all other equipment.

C. Linearity. The following requirements apply when the equipment is operated on a power supply as specified by the manufacturer in accordance with 21 CFR Part 1020 for any fixed x-ray tube potential within the range of 40% to 100% of the maximum rated.

1. Equipment having independent selection of x-ray tube current (mA). The average ratios of air kerma to the indicated milliampere-seconds product (mGy/mAs) obtained at any two consecutive tube current settings shall not differ by more than 0.10 times their sum. This is:

|X1 – X2| ≤ 0.10(X1 + X2)

where X₁and X₂ are the average mGy/mAs values obtained at each of two consecutive mAs selector settings or at two settings differing by no more than a factor of 2 where the mAs selector provides continuous selection.

2. Equipment having selection of x-ray tube current-exposure time product (mAs). For equipment manufactured after May 3, 1994, the average ratios of air kerma to the indicated milliampere-seconds product (mGy/mAs) obtained at any two consecutive mAs selector settings shall not differ by more than 0.10 times their sum. This is:

|X1 – X2| ≤ 0.10(X1 + X2)

where X₁and X₂ are the average mGy/mAs values obtained at each of two consecutive mAs selector settings or at two settings differing by no more than a factor of 2 where the mAs selector provides continuous selection.

3. Measuring compliance. Determination of compliance shall be based on four exposures, made within one hour, at each of the two settings. These two settings may include any two focal spot sizes except where one is equal to or less than 0.45 mm and the other is greater than 0.45 mm. For purposes of this requirement, focal spot size is the focal spot size specified by the x-ray tube manufacturer. The percent line-voltage regulation shall be determined for each measurement. All values for percent line-voltage regulation at any one combination of technique factors shall be within ±1 of the mean value for all measurements at these technique factors.

D. Field limitation and alignment for mobile, portable, and stationary general purpose x-ray systems. Except when spot-film devices are in service, mobile, portable, and stationary general purpose radiographic x-ray systems shall meet the following requirements:

1. Variable x-ray field limitation. A means for stepless adjustment of the size of the x-ray field shall be provided. Each dimension of the minimum field size at an SID of 100 cm shall be equal to or less than five cm.

2. Visual definition.

a. Means for visually defining the perimeter of the x-ray field shall be provided. The total misalignment of the edges of the visually defined field with the respective edges of the x-ray field along either the length or width of the visually defined field shall not exceed 2.0% of the distance from the source to the center of the visually defined field when the surface upon which it appears is perpendicular to the axis of the x-ray beam.

b. When a light localizer is used to define the x-ray field, it shall provide an average illuminance of not less than 10 foot-candles at 100 cm or at the maximum SID, whichever is less. The average illuminance shall be based on measurements made in the approximate center of each quadrant of the light field. Radiation therapy simulation systems are exempt from this requirement.

c. The edge of the light field at 100 cm or at the maximum SID, whichever is less, shall have a contrast ratio, corrected for ambient lighting, of not less than four in the case of beam-limiting devices designed for use on stationary equipment, and a contrast ratio of not less than three in the case of beam-limiting devices designed for use on mobile and portable equipment. The contrast ratio is defined as I₁/I₂, where I₁ is the illuminance three mm from the edge of the light field toward the center of the field, and I₂ is the illuminance three mm from the edge of the light field away from the center of the field. Compliance shall be determined with a measuring aperture of one mm.

E. Field indication and alignment on stationary general purpose x-ray equipment. Except when spot-film devices are in service, stationary general purpose x-ray systems shall meet the following requirements in addition to those prescribed in subsection D of this section:

1. Means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor, to align the center of the x-ray field with respect to the center of the image receptor to within 2.0% of the SID and to indicate the SID to within 2.0%;

2. The beam-limiting device shall numerically indicate the field size in the plane of the image receptor to which it is adjusted;

3. Indication of field size dimensions and SIDs shall be specified in centimeters or inches and shall be such that aperture adjustments result in x-ray field dimensions in the plane of the image receptor that correspond to those indicated by the beam-limiting device to within 2.0% of the SID when the beam axis is indicated to be perpendicular to the plane of the image receptor; and

4. Compliance measurements will be made at discrete SIDs and image receptor dimensions in common clinical use (such as SIDs of 100, 150, and 200 cm or 36, 40, 48, and 72 inches and nominal image receptor dimensions of 13, 18, 24, 30, 35, 40, and 43 cm or 5, 7, 8, 9, 10, 11, 12, 14, and 17 inches) or at any other specific dimensions at which the beam-limiting device or its associated diagnostic x-ray system is uniquely designed to operate.

F. Field limitation on radiographic x-ray equipment other than general purpose radiographic systems.

1. Equipment for use with intraoral image receptors. Radiographic equipment designed for use with an intraoral image receptor shall be provided with means to limit the x-ray beam such that:

a. If the minimum - source-skin distance (SSD) is 18 cm or more, the x-ray field at the minimum SSD shall be containable in a circle having a diameter of no more than seven cm; and

b. If the minimum SSD is less than 18 cm, the x-ray field at the minimum SSD shall be containable in a circle having a diameter of no more than six cm.

For dental intraoral uses, an open ended shielded positioning device shall be used.

2. X-ray systems designed for one image receptor size. Radiographic equipment designed for only one image receptor size at a fixed SID shall be provided with means to limit the field at the plane of the image receptor to dimensions no greater than those of the image receptor and to align the center of the x-ray field with the center of image receptor to within 2.0% of the SID, or shall be provided with means to both size and align the x-ray field such that the x-ray field at the plane of the image receptor does not extend beyond the edge of the image receptor.

3. Systems designed for mammography.

a. Radiographic systems designed only for mammography and general purpose radiography systems, when special attachments for mammography are in service, manufactured on or after November 1, 1977, and before September 30, 1999, shall be provided with means to limit the useful beam such that the x-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor at any designated SID except the edge of the image receptor designed to be adjacent to the chest wall where the x-ray field may not extend beyond this edge by more than 2.0% of the SID. This requirement can be met with a system that performs as prescribed in subdivisions 4 a, b, and c of this subsection. When the beam-limiting device and image receptor support device are designed to be used to immobilize the breast during a mammographic procedure and the SID may vary, the SID indication specified in subdivisions 4 b and c of this subsection shall be the maximum SID for which the beam-limiting device or aperture is designed.

b. Mammographic beam-limiting devices manufactured on or after September 30, 1999, shall be provided with a means to limit the useful beam such that the x-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor by more than 2.0% of the SID. This requirement can be met with a system that performs as prescribed in subdivisions 4 a, b, and c of this subsection. For systems that allow changes in SID, the SID indication specified in subdivisions 4 b and c of this subsection shall be the maximum SID for which the beam-limiting device or aperture is designed.

c. Each image receptor support device manufactured on or after November 1, 1977, intended for installation on a system designed for mammography shall have clear and permanent markings to indicate the maximum image receptor size for which it is designed.

4. Other x-ray systems. Radiographic systems not specifically covered in subsections D, E, and H of this section, which are also designed for use with extraoral image receptors and when used with an extraoral image receptor, shall be provided with means to limit the x-ray field in the plane of the image receptor so that such field does not exceed each dimension of the image receptor by more than 2.0% of the SID when the axis of the x-ray beam is perpendicular to the plane of the image receptor. In addition, means shall be provided to align the center of the x-ray field with the center of the image receptor to within 2.0% of the SID, or means shall be provided to both size and align the x-ray field such that the x-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor. These requirements may be met with:

a. A system that performs in accordance with subsections D and E of this section; or when alignment means are also provided, may be met with either;

b. An assortment of removable, fixed-aperture, beam-limiting devices sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed. Each such device shall have clear and permanent markings to indicate the image receptor size and SID for which it is designed; or

c. A beam-limiting device having multiple fixed apertures sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed. Permanent, clearly legible markings shall indicate the image receptor size and SID for which each aperture is designed and shall indicate which aperture is in position for use.

G. Positive beam limitation (PBL). The requirements of this subsection shall apply to radiographic systems that contain PBL.

1. Field size. When a PBL system is provided, it shall prevent x-ray production when:

a. Either the length or width of the x-ray field in the plane of the image receptor differs from the corresponding image receptor dimension by more than 3.0% of the SID; or

b. The sum of the length and width differences stated in subdivision 1 a of this subsection without regard to sign exceeds 4.0% of the SID.

c. The beam-limiting device is at an SID for which PBL is not designed for sizing.

2. Conditions for PBL. When provided, the PBL system shall function as described in subdivision 1 of this subsection whenever all the following conditions are met:

a. The image receptor is inserted into a permanently mounted cassette holder;

b. The image receptor length and width are less than 50 cm;

c. The x-ray beam axis is within ±3 degrees of vertical and the SID is 90 cm to 130 cm inclusive; or the x-ray beam axis is within ±3 degrees of horizontal and the SID is 90 cm to 205 cm inclusive;

d. The x-ray beam axis is perpendicular to the plane of the image receptor to within ±3 degrees; and

e. Neither tomographic nor stereoscopic radiography is being performed.

3. Measuring compliance. Compliance with the requirements of subdivision 1 of this subsection shall be determined when the equipment indicates that the beam axis is perpendicular to the plane of the image receptor and the provisions of subdivision 2 of this subsection are met. Compliance shall be determined no sooner than five seconds after insertion of the image receptor.

4. Operator initiated undersizing. The PBL system shall be capable of operating such that, at the discretion of the operator, the size of the field may be made smaller than the size of the image receptor through stepless adjustment of the field size. Each dimension of the minimum field size at an SID of 100 cm shall be equal to or less than five cm. Return to PBL function as described in subdivision 1 of this subsection shall occur automatically upon any change of image receptor size or SID.

5. Override of PBL. A capability may be provided for overriding PBL in case of system failure and for servicing the system. This override may be for all SIDs and image receptor sizes. A key shall be required for any override capability that is accessible to the operator. It shall not be possible to remove the key while PBL is overridden. Each such key switch or key shall be clearly and durably labeled as follows:

"For X-Ray Field Limitation System Failure"

The override capability is considered accessible to the operator if it is referenced in the operator's manual or in other material intended for the operator or if its location is such that the operator would consider it part of the operational controls.

H. Field limitation and alignment for spot-film devices. The following requirements shall apply to spot-film devices, except when the spot-film device is provided for use with a radiation therapy simulation system:

1. Means shall be provided between the source and the patient for adjustment of the x-ray field size in the plane of the image receptor to the size of that portion of the image receptor that has been selected on the spot-film selector. Such adjustment shall be accomplished automatically when the x-ray field size in the plane of the image receptor is greater than the selected portion of the image receptor. If the x-ray field size is less than the size of the selected portion of the image receptor, the field size shall not open automatically to the size of the selected portion of the image receptor unless the operator has selected that mode of operation.

2. Neither the length nor width of the x-ray field in the plane of the image receptor shall differ from the corresponding dimensions of the selected portion of the image receptor by more than 3.0% of the SID when adjusted for full coverage of the selected portion of the image receptor. The sum, without regard to sign, of the length and width differences shall not exceed 4.0% of the SID. On spot film devices manufactured after February 25, 1978, if the angle between the plane of the image receptor and beam axis is variable, means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor, and compliance shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.

3. The center of the x-ray field in the plane of the image receptor shall be aligned with the center of the selected portion of the image receptor to within 2.0% of the SID.

4. Means shall be provided to reduce the x-ray field size in the plane of the image receptor to a size smaller than the selected portion of the image receptor such that:

a. For spot-film devices used on fixed-SID fluoroscopic systems that are not required to and do not provide stepless adjustment of the x-ray field, the minimum field size, at the greatest SID, does not exceed 125 square cm; or

b. For spot-film devices used on fluoroscopic systems that have a variable SID or stepless adjustment of the field size, the minimum field size, at the greatest SID, shall be containable in a square of five cm by five cm.

5. A capability may be provided for overriding the automatic x-ray field size adjustment in case of system failure. If it is so provided, a signal visible at the fluoroscopist's position shall indicate whenever the automatic x-ray field size adjustment override is engaged. Each such system failure override switch shall be clearly labeled as follows:

"For X-ray Field Limitation System Failure"

I. Source-skin distance.

1. X-ray systems designed for use with an intraoral image receptor shall be provided with means to limit the source-skin distance to not less than:

a. 18 cm if operable above 50 kVp; or

b. 10 cm if not operable above 50 kVp.

2. Mobile and portable x-ray systems other than dental shall be provided with means to limit the source-skin distance to not less than 30 cm.

J. Beam-on indicators. The x-ray control shall provide visual indication whenever x-rays are produced. In addition, a signal audible to the operator shall indicate that the exposure has terminated.

K. (Reserved.)

L. Radiation from capacitor energy storage equipment. Radiation emitted from the x-ray tube shall not exceed:

1. An air kerma of 0.26 microGy (0.03 mR exposure) in one minute at five cm from any accessible surface of the diagnostic source assembly, with the beam-limiting device fully open, the system fully charged, and the exposure switch, timer, or any discharge mechanism not activated. Compliance shall be determined by measurements averaged over an area of 100 square cm, with no linear dimensions greater than 20 cm: and

2. An air kerma of 0.88 mGy (100 mR exposure) in one hour at 100 cm from the x-ray source, with beam-limiting device fully open, when the system is discharged through the x-ray tube either manually or automatically by use of a discharge switch or deactivation of the input power. Compliance shall be determined by measurements of the maximum air kerma per discharge multiplied by the total number of discharges in one hour (duty cycle). The measurements shall be averaged over an area of 100 square cm with no linear dimension greater than 20 cm.

M. Primary protective barrier for mammography x-ray systems.

1. For x-ray systems manufactured after September 5, 1978, and before September 30, 1999, which are designed only for mammography, the transmission of the primary beam through any image receptor support provided with the system shall be limited such that the air kerma five cm from any accessible surface beyond the plane of the image receptor supporting device does not exceed 0.88 microGy (0.1 mR exposure) for each activation of the tube.

2. For mammographic x-ray systems manufactured on or after September 30, 1999:

a. At any SID where exposures can be made, the image receptor support device shall provide a primary protective barrier that intercepts the cross section of the useful beam along every direction except at the chest wall edge.

b. The x-ray system shall not permit exposure unless the appropriate barrier is in place to intercept the useful beam as required in subdivision 2 a of this subdivision.

c. The transmission of the useful beam through the primary protective barrier shall be limited such that the air kerma five cm from any accessible surface beyond the plane of the primary protective barrier does not exceed 0.88 microGy (0.1 mR exposure) for each activation of the tube.

3. Compliance with the requirements of subdivisions 1 and 2 c of this subsection for transmission shall be determined with the x-ray system operated at the minimum SID for which it is designed, at maximum rated peak tube potential, at the maximum rated product of x-ray tube current and exposure time (mAs) for the maximum rated peak tube potential, and by measurements averaged over an area of 100 square cm with no linear dimension greater than 20 cm. The sensitive volume of the radiation measuring instrument shall not be positioned beyond the edge of the primary protective barrier along the chest wall side.

N. (Reserved.)

O. Beam limitation, except mammographic systems. The useful beam shall be limited to the area of clinical interest. This shall be deemed to have been met if a positive beam-limiting device meeting manufacturer's specifications and the requirements of subsection G of this section have been properly used or if evidence of collimation is shown on at least three sides or three corners of the film, for example, projections from the shutters of the collimator, cone cutting at the corners, or borders at the film's edge.

P. Radiation exposure control.

1. Exposure initiation. Means shall be provided to initiate the radiation exposure by a deliberate action on the part of the operator, such as the depression of a switch. Radiation exposure shall not be initiated without such an action. In addition, it shall not be possible to initiate an exposure when the timer is set to a "zero" or "off" position if either position is provided.

2. Exposure indication. Means shall be provided for visual indication observable at or from the operator's protected position whenever x-rays are produced. In addition, a signal audible to the operator shall indicate that the exposure has terminated.

3. Operator protection, except veterinary systems.

a. Stationary systems. Stationary x-ray systems shall be required to have the x-ray control permanently mounted in a protected area so that the operator may remain in that protected area during the entire exposure. For dental intraoral systems installed prior to September 20, 2006, if the x-ray control is not permanently mounted behind a protected barrier, then dosimetry is required by all operators of the system.

b. Mobile and portable systems. Mobile and portable x-ray systems that are:

(1) Used continuously for greater than one week in the same location, that is, a room or suite, shall meet the requirements of subdivision 3 a of this subsection;

(2) Used for less than one week at the same location shall be provided with either a protective barrier at least two meters (6.5 feet) high for operator protection during exposures, or means shall be provided to allow the operator to be at least 2.7 meters (nine feet) from the tube housing assembly during the exposure.

4. Operator protection for veterinary systems. All stationary, mobile or portable x-ray systems used for veterinary work shall be provided with either a two meter (6.5 feet) high protective barrier for operator protection during exposures, or shall be provided with means to allow the operator to be at least 2.7 meters (nine feet) from the tube housing assembly during exposures.

Q. Tube stands for portable x-ray systems. A tube stand or other mechanical support shall be used for portable x-ray systems, so that the x-ray tube housing assembly need not be hand-held during exposures.

R. Surveys. Radiation safety and equipment performance surveys shall be performed annually on all x-ray machines covered by this section in order to assure compliance with the regulations, except that bone densitometers, hand-held units, and x-ray machines other than head CT or cone beam units used in the practice of podiatry, dentistry, or veterinary medicine shall be surveyed every three years. The surveys shall be performed by or under the direct supervision of a private or state inspector who is physically present at the facility during the inspection.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 31, Issue 24, eff. August 27, 2015.

12VAC5-481-1630 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; repealed, Virginia Register Volume 31, Issue 24, eff. August 27, 2015.

12VAC5-481-1631 Intraoral dental radiographic equipment

In addition to the applicable provisions of 12VAC5-481-1591, 12VAC5-481-1601, and 12VAC5-481-1621, the requirements of this section apply to x-ray equipment and associated facilities used for dental intraoral radiography. Requirements for extraoral dental radiographic systems are in 12VAC5-481-1621.

1. Radiation exposure control. Means shall be provided to initiate the radiation exposure by a deliberate action on the part of the operator, such as the depression of a switch. Radiation exposure shall not be initiated without such an action.

2. Exposure control location and operator protection.

a. Stationary x-ray systems shall be required to have the x-ray exposure control permanently mounted in a protected area, so that the operator is required to remain in that protected area during the entire exposure; and

b. Mobile and portable x-ray systems that are:

(1) Used for greater than one week in the same location that is, a room or suite, shall meet the requirements of subdivision 2 a of this section.

(2) Used for less than one week in the same location shall be provided with either a protective barrier at least two meters (6.5 feet) high for operator protection, or means to allow the operator to be at least 2.7 meters (nine feet) from the tube housing assembly while making exposures.

3. kVp limitations. Dental x-ray machines with a nominal fixed kVp of less than 50 kVp shall not be used to make diagnostic dental radiographs of humans.

4. Administrative controls.

a. Patient and film holding devices shall be used when the techniques permit.

b. The tube housing and the PID for a permanently mounted intraoral dental system shall not be hand-held during an exposure.

c. Dental fluoroscopy without image intensification shall not be used.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 31, Issue 24, eff. August 27, 2015.

12VAC5-481-1640 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; repealed, Virginia Register Volume 31, Issue 24, eff. August 27, 2015.

12VAC5-481-1641 Computed tomography equipment

A. (Reserved.)

B. Requirements for equipment.

1. Termination of exposure.

a. Means shall be provided to terminate the x-ray exposure automatically by either de-energizing the x-ray source or shuttering the x-ray beam in the event of equipment failure affecting data collection. Such termination shall occur within an interval that limits the total scan time to no more than 110% of its preset value through the use of either a backup timer or devices that monitor equipment function.

b. A visible signal shall indicate when the x-ray exposure has been terminated through the means required by subdivision 1 a of this subsection.

c. The operator shall be able to terminate the x-ray exposure at any time during a scan, or series of scans under CT x-ray system control, of greater than one-half second duration.

2. Tomographic plane indication and alignment.

a. For any single tomogram system, means shall be provided to permit visual determination of the tomographic plane or a reference plane offset from the tomographic plane.

b. For any multiple tomogram system, means shall be provided to permit visual determination of the location of a reference plane. This reference plane can be offset from the location of the tomographic planes.

c. If a device using a light source is used to satisfy the requirements of subdivision 2 a or b of this subsection, the light source shall provide illumination levels sufficient to permit visual determination of the location of the tomographic plane or reference plane under ambient light conditions of up to 500 lux.

3. Beam-on and shutter status indicators and control switches.

a. The CT x-ray control and gantry shall provide visual indication whenever x-rays are produced and, if applicable, whether the shutter is open or closed.

b. Each emergency button or switch shall be clearly labeled as to its function.

4. Indication of CT conditions of operation. The CT x-ray system shall be designed such that the CT conditions of operation to be used during a scan or a scan sequence shall be indicated prior to the initiation of a scan or a scan sequence. On equipment having all or some of these conditions of operation at fixed values, this requirement may be met by permanent markings. Indication of CT conditions of operation shall be visible from any position from which scan initiation is possible.

5. Extraneous radiation. When data are not being collected for image production, the radiation adjacent to the tube port shall not exceed that permitted by subdivision 3 of 12VAC5-481-1601.

6. Maximum surface CTDI identification. The angular position where the maximum surface CTDI occurs shall be identified to allow for reproducible positioning of a CT dosimetry phantom.

7. Additional requirements applicable to CT x-ray systems containing a gantry manufactured after September 3, 1985.

a. The total error in the indicated location of the tomographic plane or reference plane shall not exceed five mm.

b. If the x-ray production period is less than one-half second, the indication of x-ray production shall be actuated for at least one-half second. Indicators at or near the gantry shall be discernible from any point external to the patient opening where insertion of any part of the human body into the primary beam is possible.

c. The deviation of indicated scan increment versus actual increment shall not exceed one millimeter with any mass from 0 to 100 kg resting on the support device. The patient support device shall be incremented from a typical starting position to the maximum incremented distance or 30 cm, whichever is less, and then returned to the starting position. Measurement of actual versus indicated scan increment may be taken anywhere along this travel.

d. Premature termination of the x-ray exposure by the operator shall necessitate resetting of the CT conditions of operation prior to the initiation of another scan.

C. Facility design requirements.

1. Aural communication. Provision shall be made for two-way aural communication between the patient and the operator at the control panel.

2. Viewing systems.

a. Windows, mirrors, closed-circuit television, or an equivalent shall be provided to permit continuous observation of the patient during irradiation and shall be so located that the operator can observe the patient from the control panel.

b. When the primary viewing system is by electronic means, an alternate viewing system (which may be electronic) shall be available for use in the event of failure of the primary viewing system.

D. Surveys, calibrations, spot checks, and operating procedures.

1. Surveys.

a. All CT x-ray systems installed after September 19, 2006, and those systems not previously surveyed shall have a survey made by, or under the direction of, a qualified medical physicist. In addition, such surveys shall be done after any change in the facility or equipment that might cause a significant increase in radiation hazard.

b. The registrant shall obtain a written report of the survey from the qualified medical physicist, and a copy of the report shall be made available to the agency upon request.

2. Radiation calibrations.

a. The calibration of the radiation output of the CT x-ray system shall be performed by, or under the direction of, a qualified medical physicist who is physically present at the facility during such calibration.

b. The calibration of a CT x-ray system shall be performed (i) after initial installation and before use on human patients, (ii) annually or at intervals specified by a qualified medical physicist, and (iii) after any change or replacement of components that in the opinion of the qualified medical physicist could cause a change in the radiation output.

c. The calibration of the radiation output of a CT x-ray system shall be performed with a calibrated dosimetry system. The calibration of such system shall be traceable to a national standard. The dosimetry system shall have been calibrated within the preceding two years.

d. CT dosimetry phantom shall be used in determining the radiation output of a CT x-ray system. Such phantom shall meet the following specifications and conditions of use:

(1) CT dosimetry phantom shall be right circular cylinders of polymethyl methacrylate of density 1.19 plus or minus 0.01 grams per cubic cm. The phantom shall be at least 14 cm in length and shall have diameters of 32.0 cm for testing CT x-ray systems designed to image any section of the body and 16.0 cm for systems designed to image the head or for whole body scanners operated in the head scanning mode;

(2) CT dosimetry phantom shall provide means for the placement of a dosimeter along the axis of rotation and along a line parallel to the axis of rotation 1.0 cm from the outer surface and within the phantom. Means for the placement of dosimeters or alignment devices at other locations may be provided;

(3) Any effects on the doses measured due to the removal of phantom material to accommodate dosimeters shall be accounted for through appropriate corrections to the reported data or included in the statement of maximum deviation for the values obtained using the phantom;and

(4) All dose measurements shall be performed with the CT dosimetry phantom placed on the patient couch or support device without additional attenuation materials present.

e. The calibration shall be required for each type of head, body, or whole-body scan performed at the facility.

f. Calibration shall meet the following requirements:

(1) The dose profile along the center axis of the CT dosimetry phantom for the minimum, maximum, and midrange values of the nominal tomographic section thickness used by the registrant shall be measurable. Where less than three nominal tomographic thicknesses can be selected, the dose profile determination shall be performed for each available nominal tomographic section thickness;

(2) The CTDI along the two axes specified in subdivision 2 d (2) of this subsection shall be measured. For the purpose of determining the CTDI, the manufacturer's statement as to the nominal tomographic section thickness for that particular system may be utilized. The CT dosimetry phantom shall be oriented so that the measurement point 1.0 cm from the outer surface and within the phantom is in the same angular position within the gantry as the point of maximum surface CTDI identified. The CT conditions of operation shall correspond to typical values used by the registrant; and

(3) The spot checks specified in subdivision 3 of this subsection shall be made.

g. Calibration procedures shall be in writing. Records of calibrations performed shall be maintained for inspection by the agency.

3. Spot checks.

a. The spot-check procedures shall be in writing and shall have been developed by a qualified medical physicist.

b. The spot-check procedures shall incorporate the use of a CT dosimetry phantom that has a capability of (i)providing an indication of contrast scale, noise, nominal tomographic section thickness, and the resolution capability of the system for low and high contrast objects; and (ii) measuring the mean CTN for water or other reference material.

c. All spot checks shall be included in the calibration required by subdivision 2 of this subsection and at time intervals and under system conditions specified by a qualified medical physicist.

d. Spot checks shall include acquisition of images obtained with the CT dosimetry phantom or phantoms using the same processing mode and CT conditions of operation as are used to perform calibrations required by subdivision 2 of this subsection.

e. The results of each spot check shall be maintained for two years.

4. Operating procedures.

a. The CT x-ray system shall not be operated except by an individual who has been specifically trained in its operation.

b. Information shall be available at the control panel regarding the operation and calibration of the system. Such information shall include the following:

(1) Dates of the latest calibration and spot checks and the location within the facility where the results of those tests may be obtained;

(2) Instructions on the use of the CT dosimetry phantoms including a schedule of spot checks appropriate for the system, allowable variations for the indicated parameters, and the results of at least the most recent spot checks conducted on the system;

(3) The distance in millimeters between the tomographic plane and the reference plane if a reference plane is utilized; and

(4) A current technique chart available at the control panel that specifies for each routine examination the CT conditions of operation and the number of scans per examination.

c. If the calibration or spot check of the CT x-ray system identifies that a system operating parameter has exceeded a tolerance established by the qualified medical physicist, use of the CT x-ray system on patients shall be limited to those uses permitted by established written instructions of the qualified medical physicist.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 31, Issue 24, eff. August 27, 2015.

12VAC5-481-1650 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; repealed, Virginia Register Volume 31, Issue 24, eff. August 27, 2015.

12VAC5-481-1651 Mammography requirements

A. Only x-ray systems, pursuant to the Mammography Quality Standards Reauthorization Act of 1998 (Pub.L. 105-248) and 21 CFR Part 900, shall be used for screening and diagnostic mammography.

B. A facility performing mammography shall have a valid certificate issued by the U.S. Department of Health and Human Services, pursuant to the Mammography Quality Standards Reauthorization Act of 1998 and 21 CFR Part 900.

C. A facility performing mammography shall ensure that the additional mammography activities of processing the x-ray film, interpreting the image, and maintaining viewing conditions, wherever performed, meet all quality standards pursuant to the Mammography Quality Standards Reauthorization Act of 1998 and 21 CFR Part 900.

D. The operator of the mammography machine shall be certified by the American Registry of Radiologic Technologists (ARRT) and shall have had specialized training in mammography meeting the requirements set forth by the U.S. Food and Drug Administration under the Mammography Quality Standards Reauthorization Act of 1998.

E. When film developing is not available or the patient chooses not to wait, the patient shall be notified within two business days if another mammogram is necessary. This requirement does not imply or require that a diagnostic opinion be made at the time of the mammogram. The interpreting physician may require that the mammogram be retaken if, in the opinion of the physician, the study is of inadequate quality.

F. Agency inspectors may conduct unannounced inspections during normal business hours.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 31, Issue 24, eff. August 27, 2015.

12VAC5-481-1653 Hand-held radiographic units

In addition to the applicable provisions found elsewhere in this chapter, the following provisions apply to a hand-held radiographic unit.

1. A hand-held radiograph unit shall be:

a. Certified by the manufacturer pursuant to 21 CFR Part 803, Medical Device Reporting of the Federal Food and Drug Administration Modernization Act of 1997; 21 USC Chapter 9, Subchapter V, Part C – Electronic Product Radiation Control (EPRC) (§ 360hh et seq.) of the Federal Food, Drug and Cosmetic Act; and 21 CFR 1020.30, Diagnostic x-ray systems and their major components.

b. Registered with the agency in accordance with applicable parts of this chapter.

c. Maintained and operated in accordance with the manufacturer's specifications.

2. For all uses:

a. Operators of a hand-held radiographic unit shall be specifically trained to operate such equipment.

b. When operating a hand-held radiographic unit, operators shall wear dosimetry unless otherwise authorized by the agency.

c. A hand-held radiographic unit shall have the backscatter radiation shield in place to protect the operator during operation.

d. The operator shall ensure there are no bystanders within a radius of at least six feet from the patient being examined with a hand-held radiograph unit.

e. A hand-held radiographic unit shall not be used in hallways or waiting rooms.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 31, Issue 24, eff. August 27, 2015.

12VAC5-481-1655 Bone densitometry

A. A bone densitometry system shall be:

1. Certified by the manufacturer pursuant to 21 CFR Part 803, Medical Device Reporting of the Federal Food and Drug Administration Modernization Act of 1997; 21 USC Chapter 9, Subchapter V, Part C – Electronic Product Radiation Control (EPRC) (§ 360hh et seq.) of the Federal Food, Drug and Cosmetic Act; and 21 CFR 1020.30, Diagnostic x-ray systems and their major components.

2. Registered with the agency in accordance with applicable parts of this chapter.

3. Maintained and operated in accordance with the manufacturer's specifications.

B. Equipment requirements. A system with stepless collimators shall be provided with means to both size and align the x-ray field such that the x-ray field at the plane of the image receptor does not extend beyond 2.0% of the SID.

C. Operators of a bone densitometry system shall meet one of the following:

1. Be certified by the American Registry of Radiologic Technologists (ARRT);

2. Be licensed by the Virginia Department of Health Professions, Board of Medicine as a radiologic technologist or a limited radiologic technologist for bone density operation;

3. Be licensed by the Virginia Department of Health Professions, Board of Medicine as a practitioner of the healing arts; or

4. Be in an accredited program for radiologic technology and under the supervision of an individual who meets one of the criteria listed in subdivision 1, 2, or 3 of this subsection.

D. During the operation of any bone densitometry system:

1. The operator, ancillary personnel, and members of the general public shall be positioned at least one meter from the patient and bone densitometry system during the examination.

2. The operator shall advise the patient that the bone densitometry examination is a type of x-ray procedure.

E. The registrant shall keep maintenance records for bone densitometry systems as prescribed by subdivision A 3 of this section. These records shall be maintained for inspection by the agency.

F. Bone densitometry on human patients shall be conducted only:

1. Under a prescription of an individual licensed by the Virginia Department of Health Professions, Board of Medicine as a practitioner of the healing arts; or

2. Under a screening program approved by the agency.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 31, Issue 24, eff. August 27, 2015.

12VAC5-481-1657 Quality assurance program

All registrants of diagnostic x-ray imaging equipment may be required by the agency to establish and maintain a quality assurance program consisting of quality control assessments.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 31, Issue 24, eff. August 27, 2015.

Article 1 Purpose and Scope

12VAC5-481-1660 Purpose and scope

Article 1 Purpose and Scope

Part VII (12VAC5-481-1660 et seq.) of this chapter establishes requirements and provisions for the production, preparation, compounding and use of radionuclides in the healing arts and for issuance of licenses authorizing the medical use of this material. These requirements and provisions provide for the protection of the public health and safety. The requirements and provisions of Part VII (12VAC5-481-1660 et seq.) of this chapter are in addition to, and not in substitution for, others in these regulations. The requirements and provisions of these regulations apply to applicants and licensees subject to Part VII (12VAC5-481-1660 et seq.) of this chapter unless specifically exempted.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

Article 2 General Information

12VAC5-481-1670 General requirements

Article 2 General Information

A. Licensees may conduct research involving human research subjects only if it uses the radioactive materials specified on its license for the uses authorized on its license.

B. If the research is conducted, funded, supported, or regulated by another agency that has implemented a policy for protection of human subjects, the licensee shall, before conducting research:

1. Obtain review and approval of the research from an authorized review board; and

2. Obtain informed consent, in writing, from the human research subject.

C. If the research will not be conducted, funded, supported, or regulated by another agency that has implemented an appropriate protection policy, licensees shall, before conducting research, apply for and receive a specific license amendment to its medical use license. The amendment request shall include a written commitment that licensees will, before conducting research:

1. Obtain review and approval of the research from an authorized review board; and

2. Obtain informed consent, in writing, from the human research subject.

D. Nothing in this section relieves licensees from complying with other requirements of this part.

E. Nothing in this part relieves licensees from complying with applicable FDA, federal, and other state requirements governing radioactive drugs or devices.

F. When a requirement in this part differs from the requirement in an existing license condition, the requirement in this part shall govern.

G. Licensees shall continue to comply with any license condition that requires it to implement procedures required by 12VAC5-481-2043 and 12VAC5-481-2046 until there is a license amendment or renewal that modifies the license condition.

H. Each record required by this part shall be legible throughout the specified retention period. The record may be the original, a reproduced copy, or a microform if the copy or microform is authenticated by authorized personnel and the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, and specifications shall include all pertinent information such as stamps, initials, and signatures. Licensees shall maintain adequate safeguards against tampering with and loss of records.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-1680 Licensing and exemptions

A. A person may manufacture, produce, acquire, receive, possess, prepare, use, or transfer radioactive material for medical use only in accordance with a specific license issued by the agency, the NRC, or another agreement state, or as allowed in subsection B of this section.

B. A specific license is not needed for an individual who:

1. Receives, possesses, uses, or transfers radioactive material in accordance with this part under the supervision of an authorized user as provided in 12VAC5-481-1710, unless prohibited by license condition; or

2. Prepares unsealed radioactive material for medical use in accordance with this part under the supervision of an authorized nuclear pharmacist or authorized user as provided in 12VAC5-481-1710, unless prohibited by license condition.

C. An application shall be signed by the applicant's or licensee's management.

D. An application for a license for medical use of radioactive material as described in 12VAC5-481-1900, 12VAC5-481-1920, 12VAC5-481-1950, 12VAC5-481-2010, 12VAC5-481-2020, 12VAC5-481-2040 B, and 12VAC5-481-2060 shall be made by:

1. Filing a completed and signed application for medical use; and

2. Submitting procedures required by 12VAC5-481-2043 and 12VAC5-481-2046, as applicable.

E. A request for a license amendment or renewal shall be made by:

1. Submission of a license amendment may be completed by submitting in letter format including all necessary documentation;

2. Submission for a license renewal shall be completed by submitting a completed and signed renewal application for medical use; and

3. Submitting procedures required by 12VAC5-481-2043 and 12VAC5-481-2046, as applicable.

F. In addition to the requirements in subsections D and E of this section, submittal of a license application or amendment for medical use of radioactive material as described in 12VAC5-481-2060 shall also include information regarding any radiation safety aspects of the medical use of the material that is not otherwise addressed in this part, including but not limited to, the following specific information:

1. Radiation safety precautions and instructions;

2. Training and experience of proposed users;

3. Methodology for measurement or dosages or doses to be administered to patients or human research subjects;

4. Calibration, maintenance, and repair of instruments and equipment necessary for radiation safety; and

5. Any other information requested by the agency in its review of the application.

G. An applicant that satisfies the requirements specified in 12VAC5-481-470 may apply for a specific license of broad scope. Licensees possessing a Type A specific license of broad scope for medical use, issued under 12VAC5-481-470, are exempt from:

1. The provisions of subsection E of this section regarding the need to file an amendment to the license for medical use of radioactive material, as described in 12VAC5-481-2060;

2. Additions to or changes in any authorized user, authorized nuclear pharmacist, or authorized medical physicist;

3. Additions to or changes in the areas of use at the addresses identified in the application or on the license;

4. The provisions of 12VAC5-481-1690 A;

5. The provisions of 12VAC5-481-1690 for an authorized user, an authorized nuclear pharmacist, or an authorized medical physicist;

6. The provisions of 12VAC5-481-1690 B 5;

7. The provisions of 12VAC5-481-1740.

H. The agency shall issue a license for medical use of radioactive material if:

1. The applicant has filed the appropriate application form in accordance with the instructions in this subsection and subsections D, F, G, and I of this section;

2. The applicant has paid any applicable fee as provided in 12VAC5-490;

3. The agency finds the applicant equipped and committed to observe the safety standards established by the agency in this part for the protection of the public health and safety; and

4. The applicant meets the requirements of 12VAC5-481-450.

I. The agency shall issue a license for mobile medical service if the applicant:

1. Meets the requirements of subsection H of this section and 12VAC5-481-1880; and

2. Assures that individuals or human research subjects to whom unsealed radioactive material or radiation from implants containing radioactive material will be administered may be released following treatment in accordance with 12VAC5-481-1870.

J. The agency may, upon application of any interested person or upon its own initiative, grant exemptions from the regulations in this part that it determines are authorized by law and will not endanger life, property, or the common defense and security and are otherwise in the public interest.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-1690 Notifications

A. Licensees shall provide the agency the following information for each individual no later than 30 days after the date that the licensee permits the individual to work as an authorized user, an authorized nuclear pharmacist, an ophthalmic physicist, or an authorized medical physicist:

1. A copy of (i) the board certification, (ii) the written attestation signed by a preceptor, and (iii) the NRC or another Agreement state license;

2. The permit issued by a NRC master material licensee;

3. The permit issued by a broad scope licensee;

4. The permit issued by a NRC master material broad scope permittee; or

5. Documentation that only accelerator-produced radioactive materials, discrete sources of radium-226, or both, were used for medical use or in the practice of nuclear pharmacy at a government agency or federally recognized Indian tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC.

6. For individuals permitted to work within the 30-day time frame, the licensee shall also provide, as appropriate, verification of completion of:

a. Any additional case experience required in 12VAC5-481-1980 2 b (7) for an authorized user under 12VAC5-481-1950;

b. Any additional training required in 12VAC5-481-2040 A 4 for an authorized user under 12VAC5-481-2040 A; or

c. Any additional training required in 12VAC5-481-1760 A 3 for an authorized medical physicist.

B. A licensee shall notify the agency no later than 30 days after:

1. An authorized user, an authorized nuclear pharmacist, a radiation safety officer, an associate radiation safety officer, an ophthalmic physicist, or an authorized medical physicist permanently discontinues performance of duties under the license or has a name change;

2. The licensee permits an authorized user or an individual qualified to be a radiation safety officer, under 12VAC5-481-1750 and 12VAC5-481-1790, to function as a temporary radiation safety officer and to perform the functions of a radiation safety officer in accordance with 12VAC5-481-1700 C;

3. The licensee's mailing address changes;

4. The licensee's name changes, but the name change does not constitute a transfer of control of the license as described in 12VAC5-481-500 B; or

5. The licensee has added to or changed the areas of use identified in the application or on the license where radioactive material is used in accordance with either 12VAC5-481-1900 or 12VAC5-481-1920 if the change does not include addition or relocation of either an area where PET radionuclides are produced or a PET radioactive drug delivery line from the PET radionuclide/PET radioactive drug production area.

C. The licensee shall send the documents required in this section to the appropriate address identified in 12VAC5-481-150.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022.

Article 3 General Administrative Requirements

12VAC5-481-1700 Authority and responsibilities for the radiation protection programs and changes

A. In addition to the radiation protection program requirements of 12VAC5-481-630, a licensee's management shall approve, in writing:

1. Requests for a license application, renewal, or amendment before submittal to the agency;

2. Any individual before allowing that individual to work as an authorized user, authorized nuclear pharmacist, or an authorized medical physicist; and

3. Radiation protection program changes that do not require a license amendment and are permitted under subsection I of this section.

B. The licensee's management shall appoint a radiation safety officer (RSO) who agrees, in writing, to be responsible for implementing the radiation protection program.

The licensee, through the RSO, shall ensure that radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements. A licensee's management may appoint, in writing, one or more associate RSOs to support the RSO. The RSO, with written agreement of the licensee's management, must assign the specific duties and tasks to each associate RSO. These duties and tasks are restricted to the types of use for which the associate RSO is listed on a license. The RSO may delegate duties and tasks to the associate RSO but shall not delegate the authority or responsibilities for implementing the radiation protection program.

C. For up to 60 days each year, licensees may permit an individual qualified to be an RSO, under 12VAC5-481-1750 and 12VAC5-481-1790, to function as a temporary RSO and to perform the functions of an RSO, as provided in subsection G if the licensee takes the actions required in subsections B, E, G, and H of this section and notifies the agency in accordance with 12VAC5-481-1690 B.

D. A licensee may simultaneously appoint more than one temporary RSO in accordance with subsection C of this section, if needed to ensure that the licensee has a temporary RSO that satisfies the requirements to be an RSO for each of the different types of uses of radioactive material permitted by the license.

E. A licensee shall establish the authority, duties, and responsibilities of the RSO in writing.

F. A licensee that is authorized for two or more different types of uses of radioactive material under Articles 6, 7, and 9 of this part, or two or more types of units under 12VAC5-481-2040 B, shall establish a Radiation Safety Committee (RSC) to oversee all uses of radioactive material permitted by the license. The RSC must include an authorized user of each type of use permitted by the license, the RSO, a representative of the nursing service, and a representative of management who is neither an authorized user nor an RSO. The RSC may include other members the licensee considers appropriate.

G. A licensee shall provide the RSO sufficient authority, organizational freedom, time, resources, and management prerogative to:

1. Identify radiation safety problems;

2. Initiate, recommend, or provide corrective actions;

3. Stop unsafe operations; and

4. Verify implementation of corrective actions.

H. A licensee shall retain a record of actions taken under subsections A, B, and E of this section in accordance with 12VAC5-481-2070.

I. A licensee may revise its radiation protection program without agency approval if:

1. The revision does not require a license amendment under 12VAC5-481-450 or 12VAC5-481-1680;

2. The revision is in compliance with this chapter and the license;

3. The revision has been reviewed and approved by the RSO and licensee management; and

4. The affected individuals are instructed on the revised program before the changes are implemented.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022; Volume 39, Issue 24, eff. August 16, 2023.

12VAC5-481-1710 Supervision

A. Licensees that permit the receipt, possession, use, or transfer of radioactive material by an individual under the supervision of an authorized user, as allowed by 12VAC5-481-1680 B 1, shall:

1. In addition to the requirements in 12VAC5-481-2270, instruct the supervised individual in the licensee's written radiation protection procedures, written directive procedures, regulations, and license conditions with respect to the use of radioactive material; and

2. Require the supervised individual to follow the instructions of the supervising authorized user for medical uses of radioactive material, written radiation protection procedures established by the licensee, written directive procedures, regulations, and license conditions with respect to the medical use of radioactive material.

B. Licensees that permit the preparation of radioactive material for medical use by an individual under the supervision of an authorized nuclear pharmacist or physician who is an authorized user, as allowed by 12VAC5-481-1680 B 2, shall:

1. In addition to the requirements in 12VAC5-481-2270, instruct the supervised individual in the preparation of radioactive material for medical use, as appropriate to that individual's involvement with radioactive material; and

2. Require the supervised individual to follow the instructions of the supervising authorized user or authorized nuclear pharmacist regarding the preparation of radioactive material for medical use, written radiation protection procedures established by the licensee, this chapter, and the license conditions.

C. Licensees that permit supervised activities under subsections A and B of this section are responsible for the acts and omissions of the supervised individual.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-1720 Written directives

A. A written directive shall be dated and signed by an authorized user before the administration of I-131 sodium iodide greater than 30 microcuries (µCi) (1.11 megabecquerels (MBq)), any therapeutic dose of unsealed radioactive material, or any therapeutic dose of radiation from radioactive material.

If, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive is acceptable. The information contained in the oral directive shall be documented as soon as possible in writing in the patient's record. A written directive shall be prepared within 48 hours of the oral directive.

B. The written directive shall contain the patient or human research subject's name and the following information:

1. For any administration of quantities greater than 30 µCi (1.11 MBq) of sodium iodide (I-131): the dosage;

2. For an administration of a therapeutic dosage of unsealed radioactive material other than sodium iodide (I-131): the radioactive drug, dosage, and route of administration;

3. For gamma stereotactic radiosurgery: the total dose, treatment site, and values for the target coordinate settings per treatment for each anatomically distinct treatment site;

4. For teletherapy: the total dose, dose per fraction, number of fractions, and treatment site;

5. For high dose-rate remote afterloading brachytherapy: the radionuclide, treatment site, dose per fraction, number of fractions, and total dose;

6. For permanent implant brachytherapy:

a. Before implantation: treatment site, the radionuclide, and the total source strength; and

b. After implantation but before the patient leaves the post-treatment recovery area: treatment site, number of sources implanted, total source strength implanted, and the date; or

7. For all other brachytherapy, including low, medium and pulsed dose rate remote afterloaders:

a. Before implantation: treatment site, the radionuclide, and dose; and

b. After implantation but before completion of the procedure: the radionuclide, treatment site, number of sources, and total source strength and exposure time (or the total dose) and date.

C. A written revision to an existing written directive may be made if the revision is dated and signed by an authorized user before the administration of the dosage of radioactive drug containing radioactive material, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next fractional dose.

If, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive is acceptable. The oral revision shall be documented as soon as possible in the patient's record. A revised written directive shall be signed by the authorized user within 48 hours of the oral revision.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022.

12VAC5-481-1730 Procedures for administrations requiring a written directive

For any administration requiring a written directive, licensees shall develop, implement, and maintain written directive procedures to provide high confidence that the patient's or human research subject's identity is verified before each administration and each administration is in accordance with the written directive. A licensee shall retain a copy of the procedures required by this section in accordance with 12VAC5-481-2070. At a minimum, the procedures required by this section shall address the following items that are applicable to the licensee's use of radioactive material:

1. Verifying the identity of the patient or human research subject;

2. Verifying that the specific details of the administration are in accordance with the treatment plan, if applicable, and the written directive;

3. Checking both manual and computer-generated dose calculations;

4. Verifying that all computer-generated dose calculations are correctly transferred into the consoles of therapeutic medical units authorized by 12VAC5-481-2040 B and C and 12VAC5-481-2060;

5. Determining if a medical event, as defined in 12VAC5-481-2080, has occurred; and

6. Determining, for permanent implant brachytherapy, within 60 calendar days from the date the implant was performed, the total source strength administered outside of the treatment site compared to the total source strength documented in the post-implantation portion of the written directive unless a written justification of patient unavailability is documented.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022.

12VAC5-481-1740 Suppliers for sealed sources or devices for medical use

For medical use, licensees may only use the following:

1. Sealed sources or devices manufactured, labeled, packaged, and distributed in accordance with a license issued under this part or equivalent requirements of the NRC or another agreement state;

2. Sealed sources or devices non-commercially transferred from another medical use licensee;

3. Teletherapy sources manufactured and distributed in accordance with a license issued under Part III (12VAC5-481-380 et seq.) of this chapter or equivalent requirements of the NRC or another agreement state.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-1750 Training for radiation safety officer and associate radiation safety officer

Except as provided in 12VAC5-481-1780, licensees shall require an individual fulfilling the responsibilities of the radiation safety officer (RSO) or an individual assigned duties and tasks as an associate radiation safety officer as provided in 12VAC5-481-1700 to be an individual who:

1. Is certified by a specialty board who has been recognized by the agency, the NRC, or an agreement state and who meets the requirements of subdivision 5 of this section. The names of board certifications that have been recognized by the NRC or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit Web page. To have its certification process recognized, a specialty board shall require all candidates for certification to (i) hold a bachelor's or graduate degree from an accredited college or university in physical science or engineering or biological science with a minimum of 20 college credits in physical science; (ii) have five or more years of professional experience in health physics (graduate training may be substituted for no more than two years of the required experience) including at least three years in applied health physics; and (iii) pass an examination administered by diplomates of the specialty board that evaluates knowledge and competence in radiation physics and instrumentation, radiation protection, mathematics pertaining to the use and measurement of radioactivity, radiation biology, and radiation dosimetry; or

2. Holds a master's or doctorate degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university; has two years of full-time practical training or supervised experience in medical physics (i) under the supervision of a medical physicist who is certified in medical physics by a specialty board recognized by the agency, NRC, or an agreement state or (ii) in clinical nuclear medicine facilities providing diagnostic or therapeutic services under the direction of physicians who meet the requirements for authorized users in 12VAC5-481-1780, 12VAC5-481-1940, or 12VAC5-481-1980; and has passed an examination administered by diplomates of the specialty board that assesses knowledge and competence in clinical diagnostic radiological or nuclear medicine physics and in radiation safety; or

3. Has completed a structured educational program consisting of provisions, as follows:

a. 200 hours of classroom and laboratory training in the following areas:

(1) Radiation physics and instrumentation;

(2) Radiation protection;

(3) Mathematics pertaining to the use and measurement of radioactivity;

(4) Radiation biology; and

(5) Radiation dosimetry;

b. One year of full-time radiation safety experience under the supervision of the individual identified as the RSO on an agency, NRC, or another agreement state license or permit issued by an NRC master material licensee that authorizes similar types of uses of radioactive material. An associate radiation safety officer may provide supervision for those areas for which the associate radiation safety officer is authorized on an agency, NRC, or another agreement state license or permit issued by an NRC master material licensee. The full-time radiation safety experience must involve the following:

(1) Shipping, receiving, and performing related radiation surveys;

(2) Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and instruments used to measure radionuclides;

(3) Securing and controlling radioactive material;

(4) Using administrative controls to avoid mistakes in the administration of radioactive material;

(5) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures;

(6) Using emergency procedures to control radioactive material; and

(7) Disposing of radioactive material; and

c. This individual must obtain a written attestation signed by a preceptor radiation safety officer or associate radiation safety officer who has experience with the radiation safety aspects of similar types of use of radioactive material for which the individual is seeking approval as a radiation safety officer or an associate radiation safety officer. The written attestation must state that the individual has satisfactorily completed the requirements in subdivisions 3 a, 3 b, and 5 of this section and is able to independently fulfill the radiation safety-related duties as a radiation safety officer or has an associate radiation safety officer for a medical use licensee; or

4. Meets the following qualifications:

a. Is a medical physicist who has been certified by a specialty board whose certification process has been recognized by the agency, NRC, or an agreement state under subdivision 1 of 12VAC5-481-1760 and has experience in radiation safety for similar types of use of radioactive material for which the licensee is seeking the approval of the individual as RSO or an associate radiation safety officer and who meets the requirements in subdivision 5 of this section; or

b. Is an authorized user, authorized medical physicist, or authorized nuclear pharmacist (i) identified on an agency, NRC, or another agreement state license; a permit issued by a NRC master material licensee; a permit issued by an agency, NRC, or another agreement state board scope licensee; or a permit issued by a NRC master material license board scope permittee; (ii) has experience with the radiation safety aspects of similar types of use of radioactive material for which the individual has RSO or associate radiation safety officer responsibilities; and (iii) meets subdivision 5 of this section; or

c. Has experience with the radiation safety aspects of the types of use of radioactive material for which the individual is seeking simultaneous approval both as a radiation safety officer and the authorized user on the same new medical use license or new medical use permit issued by a NRC master material licensee. The individual must also meet the requirements in subdivision 5 of this section.

5. Has training in the radiation safety, regulatory issues, and emergency procedures for the types of use for which a licensee seeks approval. This training requirement may be satisfied by completing training that is supervised by an RSO, an associate radiation safety officer, authorized medical physicist, authorized nuclear pharmacist, or authorized user, as appropriate, who is authorized for the types of use for which the licensee is seeking approval.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022; Volume 39, Issue 24, eff. August 16, 2023.

12VAC5-481-1760 Training for an authorized medical physicist

Except as provided in 12VAC5-481-1780, licensees shall require the authorized medical physicist (AMP) to be an individual who:

1. Is certified by a specialty board whose certification process has been recognized by the agency, NRC, or an agreement state and who meets the requirements of subdivision 3 of this section. The name of board certifications that have been recognized by the NRC or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:

a. Hold a master's or doctor's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university;

b. Have two years of full-time practical training or supervised experience in medical physics (i) under the supervision of a medical physicist who is certified in medical physics by a specialty board whose certification process has been recognized under this section by the agency, the NRC, or an agreement state; or (ii) in clinical radiation facilities providing high-energy, external beam therapy (photons and electrons with energies greater than or equal to 1 million electron volts) and brachytherapy services under the direction of physicians who meet the requirements in 12VAC5-481-1780, 12VAC5-481-2018, or 12VAC5-481- 2040; and

c. Pass an examination, administered by diplomates of the specialty board that assesses knowledge and competence in clinical radiation therapy, radiation safety, calibration, quality assurance, and treatment planning for external beam therapy, brachytherapy, and stereotactic radiosurgery; or

2. Meets the following requirements:

a. Holds a master's or doctor's degree in physics, biophysics, radiological physics, medical physics, health physics, other physical science, engineering, or applied mathematics from an accredited college or university or an equivalent training program approved by the agency, the NRC, or another Agreement state and has completed one year of full-time training in medical physics and an additional year of full-time practical experience under the supervision of an individual who meets the requirements for an authorized medical physicist for the types of use for which the individual is seeking authorization. This training and work experience shall be conducted in clinical radiation facilities that provide high-energy, external beam therapy (photons and electrons with energies greater than or equal to one million electron volts) and brachytherapy services and shall include:

(1) Performing sealed source leak tests and inventories;

(2) Performing decay corrections;

(3) Performing full calibration and periodic spot-checks of external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable; and

(4) Conducting radiation surveys around external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable; and

3. Has training for the types of use for which authorization is sought that includes hands-on device operation, safety procedures, clinical use, and the operation of a treatment planning system. This training requirement may be satisfied by satisfactorily completing either a training program provided by the vendor or by training supervised by an authorized medical physicist authorized for the types of use for which the individual is seeking authorization; and

4. Has obtained written attestation that the individual has satisfactorily completed the requirements of subdivisions 2 and 3 of this section; and is able to independently fulfill the radiation safety-related duties as an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status. The written attestation shall be signed by a preceptor authorized medical physicist who meets the requirements in 12VAC5-481-1760, 12VAC5-481-1780, or equivalent NRC or agreement state requirements for an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022; Errata, 38:10 VA.R. 902 January 3, 2022.

12VAC5-481-1770 Training for an authorized nuclear pharmacist

Except as provided in 12VAC5-481-1780, licensees shall require the authorized nuclear pharmacist (ANP) to be a pharmacist who:

1. Is certified by a specialty board whose certification process has been recognized by the NRC, the agency, or an agreement state. The names of board certifications that have been recognized by the NRC or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:

a. Have graduated from a pharmacy program accredited by the Accreditation Council for Pharmacy Education (ACPE) (previously named the American Council on Pharmaceutical Education) or have passed the Foreign Pharmacy Graduate Examination Committee (FPGEC) examination;

b. Hold a current, active license to practice pharmacy;

c. Provide evidence of having acquired at least 4000 hours of training or experience in nuclear pharmacy practice. Academic training may be substituted for no more than 2000 hours of the required training and experience; and

d. Pass an examination in nuclear pharmacy administered by diplomates of the specialty board that assesses knowledge and competency in procurement, compounding, quality assurance, dispensing, distribution, health and safety, radiation safety, provision of information and consultation, monitoring patient outcomes, research, and development; or

2. Meets the following requirements:

a. Has completed 700 hours in a structured educational program consisting:

(1) 200 hours of classroom and laboratory training in the following areas:

(a) Radiation physics and instrumentation;

(b) Radiation protection;

(c) Mathematics pertaining to the use and measurement of radioactivity;

(d) Chemistry of byproduct material for medical use; and

(e) Radiation biology; and

(2) Supervised practical experience in a nuclear pharmacy involving:

(a) Shipping, receiving, and performing related radiation surveys;

(b) Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and, if appropriate, instruments used to measure alpha-emitting or beta-emitting radionuclides;

(c) Calculating, assaying, and safely preparing dosages for patients or human research subjects;

(d) Using administrative controls to avoid medical events in the administration of radioactive material; and

(e) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures; and

3. Has obtained written attestation, signed by a preceptor ANP, that the individual has satisfactorily completed the requirements in subdivision 2 of this section and is able to independently fulfill the radiation safety-related duties as an authorized nuclear pharmacist.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022; Volume 39, Issue 24, eff. August 16, 2023.

12VAC5-481-1780 Training for experienced radiation safety officer, teletherapy or medical physicist, authorized medical physicist, nuclear pharmacist, authorized nuclear pharmacist, and authorized user

A. The following applies to individuals with experience as a radiation safety officer (RSO), teletherapy or medical physicist, authorized medical physicist (AMP), nuclear pharmacist, or authorized nuclear pharmacist (ANP):

1. An individual identified on an agency, NRC, or agreement state license or a permit issued by the agency, the NRC, or another agreement state broad scope licensee or master material license permit or by a master material license permittee of broad scope as an RSO, a teletherapy or medical physicist, AMP, a nuclear pharmacist, or an ANP on or before January 14, 2019, need not comply with the training requirements of 12VAC5-481-1750, 12VAC5-481-1760, or 12VAC5-481-1770, respectively, except the RSO and AMP identified in this subdivision must meet the training requirements in subdivision 5 of 12VAC5-481-1750 or subdivision 3 of 12VAC5-481-1760, as appropriate, for any material or uses for which they were not authorized prior to this date.

2. An individual certified by the American Board of Health Physics in Comprehensive Health Physics, American Board of Radiology, American Board of Nuclear Medicine, American Board of Science in Nuclear Medicine, Board of Pharmaceutical Specialties in Nuclear Pharmacy, American Board of Medical Physics in Radiation Oncology Physics, Royal College of Physicians and Surgeons of Canada in Nuclear Medicine, American Osteopathic Board of Radiology, or American Osteopathic Board of Nuclear Medicine on or before October 24, 2005, need not comply with the training requirements of 12VAC5-481-1750 to be identified as an RSO or as an associate RSO on an agency, NRC, or another agreement state license or NRC master material permit for those materials and uses that these individuals performed on or before October 24, 2005. Any individual certified by the American Board of Radiology in therapeutic radiological physics, Roentgen ray and gamma ray physics, x-ray and radium physics, or radiological physics, or certified by the American Board of Medical Physics in radiation oncology physics, on or before October 24, 2005, need not comply with the training requirements for an authorized medical physicist described in 12VAC5-481-1760 for those materials and uses that these individuals performed on or before October 24, 2005.

3. An RSO, AMP, or ANP, who used only accelerator-produced radioactive materials or discrete sources of radium-226, or both, for medical uses or in the practice of nuclear pharmacy at a government agency or federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC, need not comply with the training requirements of 12VAC5-481-1750, 12VAC5-481-1760, or 12VAC5-481-1770, respectively, when performing the same uses. A nuclear pharmacist, who prepared only radioactive drugs containing accelerator-produced radioactive materials, or a medical physicist, who used only accelerator-produced radioactive materials, at the locations and time period identified in this subdivision, qualifies as an authorized nuclear pharmacist or an authorized medical physicist, respectively, for those materials and uses performed before these dates, for purposes of this part.

B. The following applies to experienced authorized users (AU):

1. Physicians, dentists, or podiatrists identified as AUs for the medical use of radioactive material on a license issued by the agency, the NRC, or another agreement state; a permit issued by an NRC master material licensee; a permit issued by an agency, NRC, or other agreement state broad scope licensee; or a permit issued by an NRC master material license broad scope permittee on or before January 14, 2019, who perform only those medical uses for which they were authorized on or before that date need not comply with the training requirements of Articles 5 (12VAC5-481-1900 et seq.) through 9 (12VAC5-481-2040 et seq.) of this part.

2. Physicians, dentists, or podiatrists identified as AUs for the medical use of radioactive material on a license issued by the agency, the NRC, or another agreement state; a permit issued by an NRC master material licensee; a permit issued by an agency, NRC, or other agreement state broad scope licensee; or a permit issued in accordance with an NRC master material broad scope license on or before October 24, 2005, need not comply with the training requirements of Articles 5 (12VAC5-481-1900 et seq.) through 9 (12VAC5-481-2040 et seq.) of this part for those materials and uses that these individuals performed on or before October 24, 2005, as follows:

a. For uses authorized under 12VAC5-481-1900 or 12VAC5-481-1920, or oral administration of sodium iodide I-131 requiring a written directive for imaging and localization purposes, a physician who was certified on or before October 24, 2005, in nuclear medicine by the American Board of Nuclear Medicine; diagnostic radiology by the American Board of Radiology; diagnostic radiology or radiology by the American Osteopathic Board of Radiology; nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or American Osteopathic Board of Nuclear Medicine in nuclear medicine;

b. For uses authorized under 12VAC5-481-1950, a physician who was certified on or before October 24, 2005, by the American Board of Nuclear Medicine; the American Board of Radiology in radiology, therapeutic radiology, or radiation oncology; nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or the American Osteopathic Board of Radiology after 1984;

c. For uses authorized under 12VAC5-481-2010 or 12VAC5-481-2040, a physician who was certified on or before October 24, 2005, in radiology, therapeutic radiology or radiation oncology by the American Board of Radiology; radiation oncology by the American Osteopathic Board of Radiology; radiology, with specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; and

d. For uses authorized under 12VAC5-481-2020, a physician who was certified on or before October 24, 2005, in radiology, diagnostic radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology; nuclear medicine by the American Board of Nuclear Medicine; diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or nuclear medicine by the Royal College of Physicians and Surgeons of Canada.

3. Physicians, dentists, or podiatrists who used only accelerator-produced radioactive materials or discrete sources of radium-226, or both, for medical uses performed at a government agency or federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC, need not comply with the training requirements of Articles 5 (12VAC5-481-1900 et seq.) through 9 (12VAC5-481-2040 et seq.) of this part when performing the same medical uses. A physician, dentist, or podiatrist, who used only accelerator-produced radioactive materials, discrete sources of radium-226, or both for medical uses at the locations and time period identified in this subdivision, qualifies as an AU for those materials and uses performed before these dates for purposes of this chapter.

C. Individuals who need not comply with training requirements as described in this section may serve as preceptors for, and supervisors of, applicants seeking authorization on NRC licenses for the same uses for which these individuals are authorized.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022; Volume 39, Issue 24, eff. August 16, 2023.

12VAC5-481-1790 Recentness of training

The training and experience specified in this article and Articles 5 (12VAC5-481-1900 et seq.), 6 (12VAC5-481-1950 et seq.), 7 (12VAC5-481-2010 et seq.), 8 (12VAC5-481-2020 et seq.), and 9 (12VAC5-481-2040 et seq.) of this part shall have been obtained within the seven years preceding the date of the application or the individual shall have had related continuing education and experience since the required training and experience was completed.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

Article 4 General Technical Requirements

12VAC5-481-1800 Possession, use, and calibration of instruments used to measure the activity of unsealed radioactive material

Article 4 General Technical Requirements

A. For direct measurements performed in accordance with 12VAC5-481-1820, licensees shall possess and use instrumentation to measure the activity of unsealed radioactive material before it is administered to each patient or human research subject.

B. Licensees shall test the instrumentation required by subsection A of this section in accordance with nationally recognized standards or the manufacturer's instructions.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-1810 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; repealed, Virginia Register Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-1820 Determination of dosages of unsealed radioactive material for medical use

A. Licensees shall determine and record the activity of each dosage before medical use.

B. For a unit dosage, this determination shall be made by:

1. Direct measurement of the radioactivity; or

2. A decay correction based on activity or activity concentration determined by:

a. A manufacturer or preparer licensed under 12VAC5-481-480 I or equivalent NRC or other agreement state requirements;

b. An agency, NRC, or another agreement state licensee for use in research in accordance with Radioactive Drug Research Committee-approved protocol or Investigational New Drug (IND) protocol accepted by FDA; or

c. A PET radioactive drug producer licensed under 12VAC5-481-440 H or equivalent NRC or other agreement state requirements.

C. For other than unit dosages, this determination shall be made by:

1. Direct measurement of radioactivity;

2. Combination of measurement of radioactivity and mathematical calculations; or

3. Combination of volumetric measurements and mathematical calculations, based on the measurement made by:

a. A manufacturer or preparer licensed under 12VAC5-481-480 I or equivalent NRC or other agreement state requirements; or

b. A PET radioactive drug producer licensed under 12VAC5-481-440 H or equivalent NRC or other agreement state requirements.

D. Unless otherwise directed by the authorized user, licensees may not use a dosage if the dosage does not fall within the prescribed dosage range or the dosage differs from the prescribed dosage by more than 20%.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-1830 Authorization for calibration, transmission, and reference sources

Any person authorized by 12VAC5-481-1680 for medical use of radioactive material may receive, possess, and use any of the following radioactive material for check, calibration, transmission, and reference use:

1. Sealed sources, not exceeding 1.11 GBq (30 mCi) each, manufactured and distributed by a person licensed under 12VAC5-481-480 or equivalent NRC or other agreement state regulations.

2. Sealed sources, not exceeding 1.11 GBq (30 mCi) each, redistributed by a licensee authorized to redistribute the sealed sources manufactured and distributed by a person licensed under 12VAC5-481-480 or equivalent NRC or other agreement state regulations, providing the redistributed sealed sources are in the original packaging and shielding and are accompanied by the manufacturer's approved instructions.

3. Any radioactive material with a half-life not longer than 120 days in individual amounts not to exceed 0.56 GBq (15 mCi).

4. Any radioactive material with a half-life longer than 120 days in individual amounts not to exceed the smaller of 7.4 MBq (200 µCi) or 1000 times the quantities in 12VAC5-481-3730.

5. Technetium-99m in amounts as needed.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-1840 Requirements for possession of sealed sources and brachytherapy sources

A. Licensees in possession of any sealed source or brachytherapy source shall follow the radiation safety and handling instructions supplied by the manufacturer.

B. Licensees in possession of a sealed source shall:

1. Test the source for leakage before its first use unless the licensee has a certificate from the supplied indicating that the source was tested within six months before transfer to the licensee; and

2. Test the source for leakage at intervals not to exceed six months or at other intervals approved by the NRC or another agreement state in the Sealed Source and Device Registry.

C. To satisfy the leak test requirements of this section, licensees shall measure the sample so that the leak test can detect the presence of 0.005 µCi (185 Bq) of radioactive material in the sample.

D. If the leak test reveals the presence of 0.005 µCi (185 Bq) or more of removable contamination, the licensee shall:

1. Immediately withdraw the sealed source from use and store, dispose, or cause it to be repaired in accordance with the requirements in Parts III (12VAC5-481-380 et seq.) and IV (12VAC5-481-600 et seq.) of this chapter; and

2. File a report within five days of the leak test in accordance with 12VAC5-481-2080 C.

E. Licensees need not perform a leak test on the following sources:

1. Containing only radioactive material with a half-life of less than 30 days;

2. Containing only radioactive material as a gas;

3. Containing 100 µCi (3.7 MBq) or less of beta or gamma-emitting material;

4. Containing 10 µCi (0.37 MBq) or less of alpha-emitting material;

5. Seeds of iridium-192 encased in nylon ribbon; and

6. Sources stored and not being used. However, the licensee shall test each such source for leakage before any use or transfer unless it has been leak tested within six months before the date of use or transfer.

F. Licensees in possession of sealed sources or brachytherapy sources, except for gamma stereotactic radiosurgery sources, shall conduct a semi-annual physical inventory of all such sources in its possession.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-1850 Labeling of vials and syringes

Each syringe and vial that contains unsealed radioactive material shall be labeled to identify the radioactive drug. Each syringe shield and vial shield shall also be labeled unless the label on the syringe or vial is visible when shielded.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-1860 Surveys of ambient radiation exposure rate

A. In addition to the surveys required by Part IV (12VAC5-481-600 et seq.) of this chapter, licensees shall survey with a radiation detection survey instrument at the end of each day of use. Licensees shall survey all areas where unsealed radioactive material requiring a written directive was prepared for use or administered.

B. Licensees do not need to perform the surveys required by subsection A of this section in an area where patients or human research subjects are confined when they cannot be released under 12VAC5-481-1870.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-1870 Release of individuals containing unsealed radioactive material or implants containing radioactive material

A. Licensees may authorize the release from its control of any individual who has been administered unsealed radioactive material or implants containing radioactive material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 500 mrem (5 mSv).

B. Licensees shall provide the released individual, or the individual's parent or guardian, with instructions, including written instructions, on actions recommended to maintain doses to other individuals as low as is reasonable achievable if the total effective dose equivalent to any other individual is likely to exceed 100 mrem (1 mSv). If the total effective dose equivalent to a nursing infant or child could exceed 100 mrem (1 mSv), assuming there were no interruption of breast-feeding, the instructions shall also include:

1. Guidance on the interruption or discontinuation of breast-feeding; and

2. Information on the potential consequences, if any, on failure to follow guidance.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-1880 Provision of mobile medical service

A. The mobile medical service shall be licensed if the service receives, uses, or possesses radioactive material. The client of the mobile medical service shall be licensed if the client receives or possesses radioactive material to be used by a mobile medical service.

B. Licensees providing mobile medical service shall:

1. Obtain a letter signed by the management of each client for whom services are rendered that permits the use of radioactive material at the client's address and clearly delineates the authority and responsibility of the licensee and the client;

2. Inform the client's management who is on site at each client's address of use at the time that radioactive material is being administered;

3. Check instruments used to measure the activity of unsealed radioactive material for proper function before medical use at each client's address or on each day of use, whichever is more frequent. At a minimum, the check for proper function required by this subdivision shall include a constancy check;

4. Check survey instruments for proper operation with a dedicated check source before use at each client's address; and

5. Before leaving a client's address, survey all areas of use for dose rate and removable contamination to ensure compliance with the requirements in Part IV (12VAC5-481-600 et seq.) of this chapter.

C. A mobile medical service may not have radioactive material delivered from the manufacturer or the distributor to the client unless the client has a license allowing possession of the radioactive material. Radioactive material delivered to the client shall be received and handled in conformance with the client's license.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-1890 Decay-in-storage

Licensees may hold radioactive material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if it:

1. Monitors material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding; and

2. Removes or obliterates all radiation labels, except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

Article 5 Unsealed Byproduct Material – Written Directive Not Required

12VAC5-481-1900 Use of unsealed radioactive material for uptake, dilution, and excretion studies for which a written directive is not required

Article 5 Unsealed Byproduct Material – Written Directive Not Required

Except for quantities that require a written directive under 12VAC5-481-1720, licensees may use any unsealed radioactive material prepared for medical use for uptake, dilution, or excretion studies that is:

1. Obtained from a manufacturer or preparer licensed under 12VAC5-481-480 I or equivalent NRC or other agreement state regulations or a PET radioactive drug producer licensed under 12VAC5-481-440 H or equivalent NRC or other agreement state requirements;

2. Excluding PET radionuclides, prepared by (i) an ANP; (ii) a physician who is an AU and who meets the requirements specified in 12VAC5-481-1940 or 12VAC5-481-1980 and 12VAC5-481-1940 3 a 1; or (iii) an individual under supervision, as specified in 12VAC5-481-1710;

3. Obtained from and prepared by an agency, NRC, or another agreement state licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigation New Drug (IND) protocol accepted by FDA; or

4. Prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an Investigation New Drug (IND) protocol accepted by FDA for use in research.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-1910 Training for uptake, dilution, and excretion studies

Except as provided in 12VAC5-481-1780, licensees shall require an authorized user of unsealed radioactive material for the uses authorized under 12VAC5-481-1900 to be a physician:

1. Who is certified by a medical specialty board whose certification process has been recognized by the NRC, the agency, or an agreement state. The names of board certifications that have been recognized by the NRC or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit Web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:

a. Complete 60 hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed byproduct material for uptake, dilution, and excretion studies as described in subdivisions 3 a (1) through 3 a (2) (f) of this section; and

b. Pass an examination administered by diplomates of the specialty board that assesses knowledge and competence in radiation safety, radionuclide handling, and quality control; or

2. Who is an authorized user under 12VAC5-481-1940, 12VAC5-481-1980, or equivalent NRC or other Agreement state requirements; or

3. Who has:

a. Completed 60 hours of training and experience, including a minimum of eight hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material for uptake, dilution, and excretion studies. The training and experience shall include the following:

(1) Classroom and laboratory training in the following areas:

(a) Radiation physics and instrumentation;

(b) Radiation protection;

(c) Mathematics pertaining to the use and measurement of radioactivity;

(d) Chemistry of radioactive material for medical use; and

(e) Radiation biology; and

(2) Work experience under the supervision of an authorized user who meets the requirements in this section, 12VAC5-481-1780, 12VAC5-481-1940, 12VAC5-481-1980, or equivalent NRC or other Agreement state requirements, involving:

(a) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(b) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

(c) Calculating, measuring, and safely preparing patient or human research subject dosages;

(d) Using administrative controls to prevent a medical event involving the use of unsealed radioactive material;

(e) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and

(f) Administering dosages of radioactive drugs to patients or human research subjects; and

b. Obtained written attestation that the individual has satisfactorily completed the requirements in subdivision 3 a of this section and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under 12VAC-481-1900. The attestation must be obtained from either:

(1) A preceptor authorized user who meets the requirements in this section, 12VAC5-481-1780, 12VAC5-481-1940, or 12VAC5-481-1980 or equivalent NRC or other agreement state requirements; or

(2) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in this section, 12VAC5-481-1780, 12VAC5-481-1940, or 12VAC5-481-1980 or equivalent NRC or other agreement state requirements and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in subdivision 3 a of this section.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022.

12VAC5-481-1920 Use of unsealed radioactive material for imaging and localization studies for which a written directive is not required

Except for quantities that require a written directive under 12VAC5-481-1720, licensees may use any unsealed radioactive material prepared for medical use for imaging and localization studies that is:

1. Obtained from a manufacturer or preparer licensed under 12VAC5-481-480 I or equivalent NRC or other agreement state requirements or a PET radioactive drug producer licensed under 12VAC5-481-440 H or equivalent NRC or other agreement state requirements;

2. Excluding production of PET radionuclides, prepared by an ANP; a physician who is an authorized user (AU) and who meets the requirements specified in 12VAC5-481-1940, or 12VAC5-481-1980 and 12VAC5-481-1940 3 a (1) (g); or an individual under the supervision, as specified in 12VAC5-481-1710, of an ANP or a physician who is an AU;

3. Obtained from and prepared by an agency, NRC, or another agreement state licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an IND protocol accepted by FDA; or

4. Prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an IND protocol accepted by FDA.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-1930 Permissible molybdenum-99, strontium-82, and strontium-85 concentrations

A. Licensees may not administer to humans a radiopharmaceutical that contains:

1. More than 0.15 µCi of molybdenum-99 per mCi of technetium-99m (0.15 kBq of molybdenum-99 per MBq of technetium-99m); or

2. More than 0.02 µCi of strontium-82 per mCi of rubidium-82 chloride (0.02 kBq of strontium-82 per MBq of rubidium-82 chloride injection) or more than 0.2 µCi of strontium-85 per mCi of rubidium-82 (0.2 kBq of strontium-85 per MBq of rubidium-82 chloride injection).

B. A licensee that uses molybdenum-99/technetium-99m for preparing a technetium-99m radiopharmaceautical shall measure the molybdenum-99 concentration in each eluate from a generator to demonstrate compliance with subsection A of this section.

C. A licensee that uses a strontium-82/rubidium-82 generator for preparing a rubidium-82 radiopharmaceutical shall, before the first patient use of the day, measure the concentration of radionuclides strontium-82 and strontium-85 to demonstrate compliance with subsection A of this section.

D. If a licensee is required to measure the molybdenum-99 concentration or strontium-82 and strontium-85 concentrations, the licensee shall retain a record of each measurement in accordance with 12VAC5-481-2070 K.

E. The licensee shall report any measurement that exceeds the limits in subsection A of this section at the time of generator elution in accordance with 12VAC5-481-2080 D.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022; Errata, 39:5 VA.R. 943 October 24, 2022.

12VAC5-481-1940 Training for imaging and localization studies

Except as provided in 12VAC5-481-1780, licensees shall require an authorized user (AU) of unsealed radioactive material for the uses authorized under 12VAC5-481-1920 to be a physician:

1. Who is certified by a medical specialty board whose certification process has been recognized by the NRC, the agency, or an agreement state. The names of board certifications that have been recognized by the NRC or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit Web page; or

2. Who is an AU under 12VAC5-481-1980 and meets the requirements in subdivision 3 a (2) (g) of this section, or equivalent NRC or other Agreement state requirements; or

3. Who has:

a. Completed 700 hours of training and experience, including a minimum of 80 hours of classroom and laboratory training in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material for imaging and localization studies. The training and experience shall include at a minimum:

(1) Classroom and laboratory training in the following areas:

(a) Radiation physics and instrumentation;

(b) Radiation protection;

(c) Mathematics pertaining to the use and measurement of radioactivity;

(d) Chemistry of radioactive material for medical use; and

(e) Radiation biology; and

(2) Work experience, under the supervision of an authorized user who meets the requirements in this section, 12VAC5-481-1780, or 12VAC5-481-1980 and subdivision 3 a (2) (g) of this section, or equivalent NRC or other Agreement state requirements. An authorized nuclear pharmacist who meets the requirements of 12VAC5-481-1770 or 12VAC5-481-1780 may provide the supervised work experience in subdivision 3 a (2) (g) of this section. Work experience must involve:

(a) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(b) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

(c) Calculating, measuring, and safely preparing patient or human research subject dosages;

(d) Using administrative controls to prevent a medical event involving the use of unsealed radioactive material;

(e) Using procedures to safely contain spilled radioactive material and using proper decontamination procedures;

(f) Administering dosages of radioactive drugs to patients or human research subjects; and

(g) Eluting generator systems appropriate for preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radionuclide purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs; and

b. Obtained written attestation that the individual has satisfactorily completed the requirements in subdivision 3 a of this section and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under 12VAC5-481-1900 and 12VAC5-481-1920. The attestation must be obtained from either:

(1) A preceptor authorized user who meets the requirements in this section, 12VAC5-481-1780, or 12VAC5-481-1980 and subdivision 3 a (2) (g) of this section, or equivalent NRC or other agreement state requirements; or

(2) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in this section, 12VAC5-481-1780, or 12VAC5-481-1980 and subdivision 3 a (2) (g), or equivalent NRC or other agreement state requirements and concurs with the attestation provided by the residency program director. The residency training must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specific in subdivision 3 a of this section.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022.

Article 6 Unsealed Byproduct Material - Written Directive Required

12VAC5-481-1950 Use of unsealed radioactive material for which a written directive is required

Licensees may use any unsealed radioactive material identified in subdivision 2 b (7) of 12VAC5-481-1980 prepared for medical use and for which a written directive is required that is:

1. Obtained from a manufacturer or preparer licensed under 12VAC5-481-480 I or equivalent NRC or other Agreement state requirements or a PET radioactive drug producer licensed under 12VAC5-481-440 H or equivalent NRC or another agreement state requirements;

2. Excluding production of PET radionuclides, prepared by an ANP; a physician who is an authorized user (AU) and who meets the requirements specified in 12VAC5-481-1940 or 12VAC5-481-1980; or an individual under the supervision, as specified in 12VAC5-481-1710, of an ANP or the physician who is an AU;

3. Obtained from and prepared by an agency, NRC, or another agreement state licensee for use in research in accordance with an investigational new drug (IND) protocol accepted by U.S. Food and Drug Administration (FDA); or

4. Prepared by the licensee for use in research in accordance with an IND protocol accepted by FDA.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022.

12VAC5-481-1960 Safety instruction

In addition to the requirements of 12VAC5-481-2270, licensees shall provide radiation safety instruction initially and at least annually to personnel caring for patients or human research subjects who cannot be released under 12VAC5-481-1870. To satisfy this requirement, the instruction shall be commensurate with the duties of the personnel and include:

1. Patient or human research subject control;

2. Visitor control, including:

a. Routine visitation to hospitalized individuals in accordance with 12VAC5-481-720 A 1; and

b. Visitation authorized in accordance with 12VAC5-481-720 C;

3. Contamination control;

4. Waste control; and

5. Notification of the RSO, or his designee, and an authorized user if the patient or human research subject has a medical emergency or dies.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-1970 Safety precautions

A. For each patient or human research subject who cannot be released under 12VAC5-481-1870, licensees shall:

1. Quarter the patient or the human research subject either in:

a. A private room with a private sanitary facility; or

b. A room, with a private sanitary facility, with another individual who also has received therapy with unsealed byproduct material and who also cannot be released under 12VAC5-481-1870;

2. Visibly post the patient's or the human research subject's room with a "Radioactive Materials" sign;

3. Note on the door or in the patient's or human research subject's chart where and how long visitors may stay in the patient's or human research subject's room; and

4. Either monitor material and items removed from the patient's or human research subject's room to determine that their radioactivity cannot be distinguished from the natural background radiation level with a radiation detection survey instrument set on its most sensitive scale and with no interposed shielding or handle the material and items as radioactive waste.

B. Licensees shall notify the RSO, or his designee, and an AU as soon as possible if the patient or human research subject has a medical emergency or dies.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-1980 Training for use of unsealed radioactive material for which a written directive is required

Except as provided in 12VAC5-481-1780, licensees shall require an authorized user (AU) of unsealed radioactive material for the uses authorized under 12VAC5-481-1950 to be a physician:

1. Who is certified by a medical specialty board whose certification process has been recognized by the NRC, the agency, or an agreement state and who meets the requirements in subdivision 2 b (7) of this section. The names of board certifications that have been recognized by the NRC or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit Web page; or

2. Who has completed 700 hours of training and experience, including a minimum of 200 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material requiring a written directive. The training and experience shall include:

a. Classroom and laboratory training in the following areas:

(1) Radiation physics and instrumentation;

(2) Radiation protection;

(3) Mathematics pertaining to the use and measurement of radioactivity;

(4) Chemistry of radioactive material for medical use; and

(5) Radiation biology; and

b. Work experience under the supervision of an AU who meets the requirements in this section, 12VAC5-481-1780, or equivalent NRC or another agreement state requirements. A supervising AU, who meets the requirements of this subdivision 2 shall also have experience in administering dosages in the same dosage category or categories (i.e., subdivision 2 b (7) of this section) as the individual requesting authorized user status. The work experience shall involve:

(1) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(2) Performing quality control procedures on instruments used to determine the activity of dosages, and performing checks for proper operation of survey meters;

(3) Calculating, measuring, and safely preparing patient or human research subject dosages;

(4) Using administrative controls to prevent a medical event involving the use of unsealed radioactive material;

(5) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures;

(6) (Reserved.)

(7) Administering dosages of radioactive drugs to patients or human research subjects from the three categories in this subdivision 2 b (7). Radioactive drugs containing radionuclides in categories not included in this subdivision are regulated under 12VAC5-481-2060.This work experience must involve a minimum of three cases in each of the following categories (experience with at least three cases in subdivision 2 b (7) (b) of this section also satisfies the requirements of subdivision 2 b (7) (a) of this section) for which the individual is requesting authorized user status.

(a) Oral administration of less than or equal to 33 mCi (1.22 GBq) of sodium iodide I-131, for which a written directive is required;

(b) Oral administration of greater than 33 mCi (1.22 GBq) of sodium iodide I-131;

(c) Parenteral administration of any radioactive drug that contains a radionuclide that is primarily used for its electron emission, beta radiation characteristics, alpha characteristics, or photon energy of less than 150 keV, for which a written directive is required; and

3. Who has obtained written attestation that the individual has satisfactorily completed the requirements in subdivision 2 b of this section and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131 for medical uses authorized under 12VAC5-481-1950. The written attestation shall be obtained from either:

a. A preceptor AU who meets the requirements in this section, 12VAC5-481-1780, or equivalent NRC or other agreement state requirements and has experience in administering dosages in the same dosage category (i.e., subdivision 2 b (7) of this section) as the individual requesting authorized user status; or

b. A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements of this section, 12VAC5-481-1780, or equivalent NRC or other agreement state requirements; has experience in administering dosages in the same dosage category as the individual requesting the authorized user status; and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include the training and experience specified in subdivision 2 b of this section.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022; Errata, 38:10 VA.R. 902 January 3, 2022.

12VAC5-481-1990 Training for the oral administration of sodium iodide (I-131) requiring a written directive in quantities less than or equal to 33 mCi (1.22 GBq)

Except as provided in 12VAC5-481-1780, licensees shall require an authorized user (AU) for the oral administration of sodium iodide (I-131) requiring a written directive in quantities less than or equal to 33 mCi (1.22 GBq) to be a physician:

1. Who is certified by a medical specialty board whose certification process includes all of the requirements of subdivision 3 of this section and has been recognized by the NRC, the agency, or an agreement state. The names of board certifications that have been recognized by the NRC or an agreement state are posted on the NRC's Medical Licensee Toolkit Web page; or

2. Who is an AU under 12VAC5-481-1980 for uses listed in subdivision 2 b (7) (a) and (b) of 12VAC5-481-1980, 12VAC5-481-2000, or equivalent NRC or other agreement state requirements; or

3. Who has:

a. Completed 80 hours of classroom and laboratory training, applicable to the medical use of sodium iodide (I-131) for procedures requiring a written directive. The training shall include:

(1) Radiation physics and instrumentation;

(2) Radiation protection;

(3) Mathematics pertaining to the use and measurement of radioactivity;

(4) Chemistry of byproduct material for medical use; and

(5) Radiation biology; and

b. Work experience under the supervision of an AU who meets the requirements in this section, 12VAC5-481-1780, 12VAC5-481-1980, 12VAC5-481-2000, or equivalent NRC or another agreement state requirements. A supervising AU who meets the requirements in subdivision 2 of 12VAC5-481-1980 shall also have experience in administering dosages as specified in subdivision 2 b (7) (a) or subdivision 2 b (7) (b) of 12VAC5-481-1980. The work experience shall involve:

(1) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(2) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

(3) Calculating, measuring, and safely preparing patient or human research subject dosages;

(4) Using administrative controls to prevent a medical event involving the use of byproduct material;

(5) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and

(6) Administering dosages to patients or human research subjects, that includes at least three cases involving the oral administration of less than or equal to 33 mCi (1.22 GBq) of sodium iodide (I-131); and

4. Obtained written attestation that the individual has satisfactorily completed the requirements in subdivision 3 of this section and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131 for medical uses authorized under 12VAC5-481-1950. The attestation must be obtained from either:

a. A preceptor authorized user who meets the requirements in this section, 12VAC5-481-1780, 12VAC5-481-1980, 12VAC5-481-2000, or equivalent NRC or other agreement state requirements and has experience in administering dosages as specified in subdivision 2 b (7) (a) or (b) of 12VAC5-481-1980; or

b. A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in this section, 12VAC5-481-1780, 12VAC5-481-1980, 12VAC5-481-2000, or equivalent NRC or other agreement state requirements, has experience in administering dosages as specified in 12VAC5-481-1980 2 b (7) (a) or (b), and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in subdivision 3 of this section.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022.

12VAC5-481-2000 Training for the oral administration of sodium iodide (I-131) requiring a written directive in quantities greater than 33 mCi (1.22 GBq)

Except as provided in 12VAC5-481-1780, licensees shall require an authorized user (AU) for the oral administration of sodium iodide (I-131) requiring a written directive in quantities greater than 33 mCi (1.22 GBq) to be a physician:

1. Who is certified by a medical specialty board whose certification process includes all of the requirements in subdivision 3 of this section and has been recognized by the NRC, the agency, or an agreement state. The names of board certifications that have been recognized by the NRC or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit Web page; or

2. Who is an AU under 12VAC5-481-1980 for uses listed in subdivision 2 b (7) (b) of 12VAC5-481-1980 or equivalent NRC or other agreement state requirements; or

3. Who has:

a. Completed 80 hours of classroom and laboratory training, applicable to the medical use of sodium iodide (I-131) for procedures requiring a written directive. The training shall include:

(1) Radiation physics and instrumentation;

(2) Radiation protection;

(3) Mathematics pertaining to the use and measurement of radioactivity;

(4) Chemistry of radioactive material for medical use; and

(5) Radiation biology; and

b. Work experience, under the supervision of an AU who meets the requirements in this section, 12VAC5-481-1780, 12VAC5-481-1980, or equivalent NRC or other agreement state requirements. A supervising AU who meets the requirements in subdivision 2 of 12VAC5-481-1980 shall also have experience in administering dosages as specified in subdivision 2 b (7) (b) of 12VAC5-481-1980. The work experience shall involve:

(1) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(2) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

(3) Calculating, measuring, and safely preparing patient or human research subject dosages;

(4) Using administrative controls to prevent a medical event involving the use of radioactive material;

(5) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and

(6) Administering dosages to patients or human research subjects that includes at least three cases involving the oral administration of greater than 33 mCi (1.22 GBq) of sodium iodide (I-131); and

c. Obtained written attestation that the individual has satisfactorily completed the requirements in subdivision 3 of this section and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131 for medical uses authorized under 12VAC5-481-1950. The written attestation must be obtained by either:

(1) A preceptor authorized user who meets the requirements in this section, 12VAC5-481-1780, 12VAC5-481-1980, or equivalent NRC or other Agreement state requirements and has experience in administering dosages as specified in subdivision 2 b (7) (b) of 12VAC5-481-1980; or

(2) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements of this section, 12VAC5-481-1780, 12VAC5-481-1980, or equivalent NRC or other agreement state requirements; has experience in administering dosages as specified in 12VAC5-481-1980 2 b (7) (b); and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience as specified in this subdivision 3.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022.

12VAC5-481-2001 Training for the parenteral administration of unsealed radioactive material requiring a written directive

Except as provided in 12VAC5-481-1780, licensees shall require an authorized user (AU) for the parenteral administration requiring a written directive to be a physician:

1. Who is an AU under 12VAC5-481-1980 for uses listed in subdivision 2 b (7) (c) of 12VAC5-481-1980 or equivalent NRC or other Agreement state requirements; or

2. Who is an AU under 12VAC5-481-2018, 12VAC5-481-2040, or equivalent NRC or other agreement state requirements and who meets the requirements in subdivision 4 of this section; or

3. Who is certified by a medical specialty board whose certification process has been recognized by the NRC, the agency, or an agreement state under 12VAC5-481-2018 or 12VAC5-481-2040 and who meets the requirements in subdivision 4 of this section;

4. Who has:

a. Completed 80 hours of classroom and laboratory training applicable to parenteral administrations. The training shall include:

(1) Radiation physics and instrumentation;

(2) Radiation protection;

(3) Mathematics pertaining to the use and measurement of radioactivity;

(4) Chemistry of radioactive material for medical use; and

(5) Radiation biology; and

b. Work experience under the supervision of an AU who meets the requirements in this section, 12VAC5-481-1780, 12VAC5-481-1980, or equivalent NRC or other Agreement state requirements in the parenteral administration listed in 12VAC5-481-1980 2 b (7) (c). A supervising AU who meets the requirements in this section, 12VAC5-481-1980, or equivalent NRC or other agreement state requirements shall have experience in administering dosages in the same category as the individual requesting authorized user status. The work experience shall involve:

(1) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(2) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

(3) Calculating, measuring, and safely preparing patient or human research subject dosages;

(4) Using administrative controls to prevent a medical event involving the use of unsealed radioactive material;

(5) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and

(6) Administering dosages to patients or human research subjects that include at least three cases of the parenteral administration as specified in 12VAC5-481-1980 2 b (7) (c); and

5. Obtained a written attestation that the individual has satisfactorily completed the requirements in subdivision 4 of this section and is able to independently fulfill the radiation safety-related duties as an authorized user for the parenteral administration of unsealed byproduct material requiring a written directive. The written attestation shall be obtained from either:

a. A preceptor AU who meets the requirements in this section, 12VAC5-481-1780, 12VAC5-481-1980, or equivalent NRC or other agreement state requirements. A preceptor AU who meets the requirements in this section, 12VAC5-481-1980, or equivalent NRC or other agreement state requirements shall have experience in administering dosages in the same category as the individual requesting authorized user status; or

b. A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements of this section, 12VAC5-481-1780, 12VAC5-481-1980, or equivalent NRC or other agreement state requirements; has experience in administering dosages in the same dosage category as the individual requesting authorized user status; and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council of Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in subdivision 4 of this section.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008; amended, Virginia Register Volume 32, Issue 24, eff. August 25, 2016; Errata 37:14 VA.R. 2151 March 1, 2021; Volume 37, Issue 25, eff. January 14, 2022; Errata 38:10 VA.R. 902 January 3, 2022.

Article 7 Manual Brachytherapy

12VAC5-481-2010 Use of sources for manual brachytherapy

Licensees shall use only brachytherapy sources:

1. As approved in the Sealed Source and Device Registry for manual brachytherapy medical use. The manual brachytherapy sources may be used for manual brachytherapy uses that are not explicitly listed in the Sealed Source and Device Registry but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry; or

2. In research to deliver therapeutic doses for medical use in accordance with an active Investigational Device Exemption application accepted by the U.S. Food and Drug Administration provided the requirements of 12VAC5-481-1740 are met.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022.

12VAC5-481-2011 Surveys after source implant and removal

A. Immediately after implanting sources in a patient or a human research subject, the licensee shall make a survey to locate and account for all sources that have not been implanted.

B. Immediately after removing the last temporary implant source from a patient or a human research subject, the licensee shall make a survey of the patient or the human research subject with a radiation detection survey instrument to confirm that all sources have been removed.

C. A licensee shall retain a record of the surveys required by subsections A and B of this section in accordance with 12VAC5-481-2070 O.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2012 Brachytherapy sources accountability

A. Licensees shall maintain accountability at all times for all brachytherapy sources in storage or use.

B. As soon as possible after removing sources from a patient or a human research subject, licensees shall return brachytherapy sources to a secure storage area.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2013 Safety instruction

A. In addition to the requirements of 12VAC5-481-2270, licensees shall provide radiation safety instruction initially and at least annually, to personnel caring for patients or human research subjects who are receiving brachytherapy and cannot be released under 12VAC5-481-1870.

B. To satisfy this requirement, the instruction shall be commensurate with the duties of the personnel and include:

1. Size and appearance of the brachytherapy sources;

2. Safe handling and shielding instructions;

3. Patient or human research subject control;

4. Visitor control, including both:

a. Routine visitation of hospitalized individuals in accordance with 12VAC5-481-720 A 1; and

b. Visitation authorized in accordance with 12VAC5-481-720 C; and

5. Notification of the RSO, or his designee, and an AU if the patient or the human research subject has a medical emergency or dies. The licensee shall also notify the agency if it is possible that any individual could receive exposures in excess of regulatory limits as a result of the deceased's body.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2014 Safety precautions

A. For each patient or human research subject who is receiving brachytherapy and cannot be released under 12VAC5-481-1870, licensees shall:

1. Not quarter the patient or human research subject in the same room as an individual who is not receiving brachytherapy;

2. Visibly post the patient's or human research subject's room with a "Radioactive Materials" sign; and

3. Note on the door or in the patient's or human research subject's chart where and how long visitors may stay in the patient's or human research subject's room.

B. Licensees shall have applicable emergency response equipment available near each treatment room to respond to a source that becomes:

1. Dislodged from the patient; and

2. Lodged within the patient following removal of the source applicators.

C. Licensees shall notify the RSO, or his designee, and an AU as soon as possible if the patient or human research subject has a medical emergency or dies.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2015 Calibration measurements of brachytherapy sources

A. Before the first medical use of a brachytherapy source, licensees shall have:

1. Determined the source output or activity using a dosimetry system that meets the requirements of 12VAC5-481-2044;

2. Determined source positioning accuracy with applicators; and

3. Used published protocols currently accepted by nationally recognized bodies to meet the requirements of subdivision 1 and 2 of this subsection.

B. Instead of a licensee making its own measurements as required in subsection A of this section, the licensee may use measurements provided by the source manufacturer or by a calibration laboratory accredited by the American Association of Physicists in Medicine that are made in accordance with subsection A of this section.

C. A licensee shall mathematically correct the outputs or activities determined in subsection A of this section for physical decay at intervals consistent with 1.0% physical decay.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2016 Strontium-90 sources for ophthalmic treatments

A. Licensees who use strontium-90 for ophthalmic treatments must ensure that certain activities as specified in subsection B of this section are performed by either:

1. An authorized medical physicist; or

2. An individual who:

a. Is identified as on ophthalmic physicist on a specific medical use license issued the agency, NRC, or another agreement state; permit issued by an agency, NRC, or another agreement state broad scope licensee; medical use permit issued by a NRC master material licensee; or permit issued by a NRC master material broad scope medical use permittee;

b. Holds a master's or doctor's degree in physics, medical physics, other physical sciences, engineering, or applied mathematics from an accredited college or university;

c. Has successfully completed one year of full-time training in medical physics and an additional year of full-time work experience under the supervision of a medical physicist; and

d. Has documented training in the following:

(1) The creation, modification, and completion of written directives;

(2) Procedures for administrations requiring a written directive; and

(3) Performing the calibration measurements of brachytherapy sources as detailed in 12VAC5-481-2015.

B. The individuals who are identified in subsection A of this section must:

1. Calculate the activity of each strontium-90 sources that is used to determine the treatment times for ophthalmic treatments. The decay must be based on the activity determined under 12VAC5-481-2015; and

2. Assist the licensee in developing, implementing, and maintaining written procedures to provide a high confidence that the administration is in accordance with the written directive. These procedures must include the frequencies that the individual meeting the requirements in subsection A of this section will observe treatments, review the treatment methodology, calculate treatment time for prescribed dose, and review records to verify that the administrations were in accordance with the written directive.

C. Licensees must retain a record of the activity of each strontium-90 source in accordance with 12VAC5-481-2070 P.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016; amended, Virginia Register Volume 37, Issue 25, eff. January 14, 2022; Errata, 38:10 VA.R. 902 January 3, 2022.

12VAC5-481-2017 Therapy-related computer systems

Licensees shall perform acceptance testing on the treatment planning system of therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing shall include, as applicable, verification of:

1. The source-specific input parameters required by the dose calculation algorithm;

2. The accuracy of dose, dwell time, and treatment time calculations at representative points;

3. The accuracy of isodose plots and graphic displays; and

4. The accuracy of the software used to determine sealed source positions from radiographic images.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2018 Training for use of manual brachytherapy sources

Except as provided in 12VAC5-481-1780, licensees shall require an authorized user of a manual brachytherapy source for uses authorized under 12VAC5-481-2010 to be a physician:

1. Who is certified by a medical specialty board whose certification process has been recognized by the NRC, the agency, or an agreement state. The names of board certifications that have been recognized by the NRC or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit Web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:

a. Successfully complete a minimum of three years of residency training in a radiation oncology program approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association; and

b. Pass an examination administered by diplomates of the specialty board that tests knowledge and competence in radiation safety, radionuclide handling, treatment planning, quality assurance, and clinical use of manual brachytherapy; or

2. Who has:

a. Completed a structured educational program in basic radionuclide handling techniques applicable to the use of manual brachytherapy sources that includes:

(1) 200 hours of classroom and laboratory training in the following areas:

(a) Radiation physics and instrumentation;

(b) Radiation protection;

(c) Mathematics pertaining to the use and measurement of radioactivity; and

(d) Radiation biology; and

(2) 500 hours of work experience, under the supervision of an authorized user who meets the requirements in this subsection, 12VAC5-481-1780, or equivalent NRC or another agreement state requirements at a medical facility authorized to use radioactive material under 12VAC5-481-2010, involving:

(a) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(b) Checking survey meters for proper operation;

(c) Preparing, implanting, and removing brachytherapy sources;

(d) Maintaining running inventories of material on hand;

(e) Using administrative controls to prevent a medical event involving the use of radioactive material;

(f) Using emergency procedures to control radioactive material; and

b. Completed three years of supervised clinical experience in radiation oncology, under an AU who meets the requirements in this section, 12VAC5-481-1780, or equivalent NRC or another agreement state requirements, as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by subdivision 2 a (2) of this section.

3. Who has obtained written attestation that the individual has satisfactorily completed the requirements in subdivision 2 of this section and has achieved a level of competency sufficient to function independently as an AU of manual brachytherapy sources for the medical uses authorized in 12VAC5-481-2010. This attestation must be obtained from either:

a. A preceptor authorized user who meets the requirements in this section, 12VAC5-481-1780, or equivalent NRC or other agreement state requirements; or

b. A residency program director who affirms in writing that the attestation represents the residency program faculty where at least one faculty member is an authorized user who meets the requirement in this section, 12VAC5-481-1780, or equivalent NRC or other agreement state requirements and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specific in subsection 2 of this section.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016; amended, Virginia Register Volume 37, Issue 25, eff. January 14, 2022; Volume 39, Issue 24, eff. August 16, 2023.

12VAC5-481-2019 Training for ophthalmic use of strontium-90

Except as provided in 12VAC5-481-1780, licensees shall require the AU of strontium-90 for ophthalmic radiotherapy to be a physician:

1. Who is an authorized user (AU) under 12VAC5-481-2018 or equivalent NRC or other Agreement state requirements; or

2. Who has:

a. Completed 24 hours of classroom and laboratory training applicable to the medical use of strontium-90 for ophthalmic radiotherapy. The training shall include:

(1) Radiation physics and instrumentation;

(2) Radiation protection;

(3) Mathematics pertaining to the use and measurement of radioactivity; and

(4) Radiation biology; and

b. Clinical training in ophthalmic radiotherapy under the supervision of an authorized user at a medical institution, clinic, or private practice that includes the use of strontium-90 for the ophthalmic treatment of five individuals. This supervised clinical training shall involve:

(1) Examination of each individual to be treated;

(2) Calculation of the dose to be administered;

(3) Administration of the dose; and

(4) Follow up and review of each individual's case history; and

c. Obtained written attestation, signed by a preceptor AU who meets the requirements in 12VAC5-481-1780, 12VAC5-481-2018, this section, or equivalent NRC or other Agreement state requirements, that the individual has satisfactorily completed the requirements in this subdivision 2 and is able to independently fulfill the radiation safety-related duties as an authorized user of strontium-90 for ophthalmic use.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016; amended, Virginia Register Volume 37, Issue 25, eff. January 14, 2022.

Article 8 Sealed Sources for Diagnosis

12VAC5-481-2020 Use of sealed sources for diagnosis

A. Licensees shall use only sealed sources that are not in medical devices for diagnostic medical uses if the sealed sources are approved in the Sealed Source and Device Registry but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry.

B. A licensee must only use medical devices containing sealed sources for diagnostic medical uses if both the sealed sources and medical devices are approved in the Sealed Source and Device Registry for diagnostic medical uses. The diagnostic medical devices may be used for diagnostic medical uses that are not explicitly listed in the Sealed Source and Device Registry but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry.

C. Sealed sources and devices for diagnostic medical uses may be used in research in accordance with an active Investigational Device Exemption application accepted by the U.S. Food and Drug Administration provided the requirements of 12VAC5-481-1740 are met.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022.

12VAC5-481-2030 Training for use of sealed sources for diagnosis

Except as provided by 12VAC5-481-1780, licensees shall require the authorized user of a diagnostic sealed source for use in a device authorized under 12VAC5-481-2020 to be a physician, dentist, or podiatrist who:

1. Is certified by a specialty board whose certification process includes all of the requirements in subdivisions 3 and 4 of this section and whose certification has been recognized by the NRC, the agency, or an agreement state. The names of board certifications that have been recognized by the NRC or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit Web page; or

2. Is an authorized user for uses listed under 12VAC5-481-1920 or equivalent NRC or other agreement state requirements; or

3. Has completed eight hours of classroom and laboratory training in basic radionuclide handling techniques specifically applicable to the use of the device. The training shall include:

a. Radiation physics and instrumentation;

b. Radiation protection;

c. Mathematics pertaining to the use and measurement of radioactivity; and

d. Radiation biology; and

4. Has completed training in the use of the device for the uses requested.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022.

Article 9 Photon Emitting Remote Afterloader Units, Teletherapy Units, and Stereotactic Radiosurgery Units

12VAC5-481-2040 Training requirements and use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit

A. Except as provided in 12VAC5-481-1780, licensees shall require an authorized user (AU) of a sealed source in remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units to be a physician:

1. Who is certified by a medical specialty board whose certification process has been recognized by the NRC, the agency, or an agreement state and who meets the requirements in subdivision 4 of this section. The names of board certifications that have been recognized by the agency, NRC, or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit Web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:

a. Successfully complete a minimum of three years of residency training in a radiation therapy program approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association; and

b. Pass an examination administered by diplomates of the specialty board that tests knowledge and competence radiation safety, radionuclide handling, treatment planning, quality assurance, and clinical use of stereotactic radiosurgery, remote afterloaders and external beam therapy; or

2. Who has:

a. Completed a structured educational program in basic radionuclide techniques applicable to the use of a sealed source in a therapeutic medical unit that includes:

(1) 200 hours of classroom and laboratory training in the following areas: radiation physics and instrumentation; radiation protection; mathematics pertaining to the use and measurement of radioactivity; and radiation biology; and

(2) 500 hours of work experience, under the supervision of an AU who meets the requirements in this section, 12VAC5-481-1780, or equivalent NRC or another agreement state requirements at a medical institution that is authorized for subsections B and C of this section, involving: reviewing full calibration measurements and periodic spot-checks; preparing treatment plans and calculating treatment doses and times; using administrative controls to prevent a medical event involving the use of radioactive material; implementing emergency procedures to be followed in the event of the abnormal operation of the medical unit or console; checking and using survey meters; and selecting the proper dose and knowing how it is to be administered; and

b. Completed three years of supervised clinical experience in radiation therapy under an AU who meets the requirements in this section, 12VAC5-481-1780, or equivalent NRC or another agreement state requirements as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by this subdivision 2.

3. Who has obtained written attestation that the individual has satisfactorily completed the requirements in subdivisions 2 a, 2 b, and 4 of this subsection and has achieved a level of competency sufficient to function independently as an AU of each type of therapeutic medical unit for which the individual is requesting AU status. The written attestation shall be signed by either:

a. A preceptor AU who meets the requirements in this subsection, 12VAC5-481-1780, or equivalent NRC or another agreement state requirements for an AU for each type of therapeutic medical unit for which the individual is requesting AU status; or

b. A residency program director who affirms in writing that the attestation of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in this subsection, 12VAC5-481-1780, or equivalent NRC or other agreement state requirements for the type of therapeutic medical unit for which the individual is requesting authorized user status and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in subdivisions 2 a and 2 b of this subsection.

4. Who has received training in device operation, safety procedures, and clinical use for the types of use for which authorization is sought. This training requirement may be satisfied by satisfactory completion of a training program provided by the vendor for new users or by receiving training supervised by an AU or authorized medical physicist, as appropriate, who is authorized for the types of use for which the individual is seeking authorization.

B. Licensees shall use sealed sources in photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units for therapeutic medical uses:

1. As approved in the Sealed Source and Device Registry; or

2. In research in accordance with an active Investigational Device Exemption application accepted by the U.S. Food and Drug Administration provided the requirements of 12VAC5-481-1740 are met.

C. Licensees shall use photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units:

1. As approved in the Sealed Source and Device Registry to deliver a therapeutic dose for medical use. These devices may be used for therapeutic medical treatments that are not explicitly provided for in the Sealed Source and Device Registry but must be used in accordance with radiation safety conditions and limitations described in the Sealed Source and Device Registry; or

2. In research in accordance with an active Investigational Device Exemption application accepted by the U.S. Food and Drug Administration provided the requirements of 12VAC5-481-1740 are met.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022; Errata, 38:10 VA.R. 902 January 3, 2022; amended, Virginia Register Volume 39, Issue 24, eff. August 16, 2023.

12VAC5-481-2041 Surveys required

A. Radiation surveys.

1. In addition to the survey requirements in 12VAC5-481-750, licensees shall make surveys to ensure that the maximum radiation levels and average radiation levels from the surface of the main source safe with the source in the shielded position do not exceed the levels stated in the Sealed Source and Device Registry.

2. The licensee shall make the survey required by subdivision 1 of this subsection at installation of a new source and following repairs to the source shielding, the source driving unit, or other electronic or mechanical component that could expose the source, reduce the shielding around the source, or compromise the radiation safety of the unit or the source.

B. Patient surveys. Before releasing a patient or human research subject from licensee control, a licensee shall survey the patient or human research subject and the remote afterloader unit with a portable radiation detection survey instrument to confirm that the source has been removed from the patient or human research subject and returned to the safe shielded position.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 24, eff. August 24, 2016.

12VAC5-481-2042 Installation, maintenance, adjustment, and repair

A. Only a person specifically licensed by the agency, the NRC, or another agreement state shall install, maintain, adjust, or repair a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit that involves work on the source shielding, the source driving unit, or other electronic or mechanical components that could expose the source, reduce the shielding around the source, or compromise the radiation safety of the unit or the source.

B. Except for low dose-rate remove afterloader unit, only a person specifically licensed by the agency, the NRC, or another agreement state shall install, replace, relocate, or remove a sealed source or source contained in other remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units.

C. For a low dose-rate remote afterloader unit, only a person specifically licensed by the agency, the NRC, or another agreement state or an authorized medical physicist shall install, replace, relocate, or remove a sealed source contained in the unit.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2043 Safety procedures and instructions, and precautions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units

A. Safety procedures and instructions.

1. Licensees shall:

a. Secure the unit, the console, the console keys, and the treatment room when not in use or unattended;

b. Permit only individuals approved by the authorized user (AU), the authorized medical physicist (AMP), or the RSO to be present in the treatment room during treatment with sources;

c. Prevent dual operation of more than one radiation producing device in a treatment room if applicable; and

d. Develop, implement, and maintain written procedures for responding to an abnormal situation when the operator is unable to place the source in the shielded position, or remove the patient or human research subject from the radiation field with controls from the outside the treatment room. These procedures shall include:

(1) Instructions for responding to equipment failure and the names of the individuals responsible for implementing corrective actions;

(2) The process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure; and

(3) The names and telephone numbers of the authorized user (AU), the authorized medical physicist (AMP), and the RSO to be contacted if the unit or the console operates abnormally.

2. A copy of the procedures required by subdivision 1 d of this subsection shall be physically located at the unit console.

3. Licensees shall post instructions at the unit console to inform the operator of:

a. The location of the procedures required by subdivision 1 d of this subsection; and

b. The names and telephone numbers of the AU, the AMP, and the RSO to be contacted if the unit or console operates abnormally.

4. Safety instruction and training.

a. Prior to the first use of patient treatment of a new unit or an existing unit with a manufacturer upgrade that affects the operation and safety of the unit, a licensee shall ensure that vendor operational and safety training is provided to all individuals who will operate the unit. The vendor operational and safety training must be provided by the device manufacturer or by an individual certified by the device manufacturer to provide the operational and safety training.

b. Licensees shall provide instruction initially and at least annually to all individuals who operate the unit, as appropriate to the individual's assigned duties, in the procedures identified in subdivision 1 d of this subsection and the operating procedures for the unit.

5. Licensees shall ensure that operators, authorized users, and authorized medical physicists participate in drills of the emergency procedures initially and at least annually and document the exercise.

6. Licensees shall retain a record of individuals receiving instruction required by subdivision 4 of this subsection in accordance with 12VAC5-481-2070 L.

7. Licensees shall retain a copy of the procedures required by subdivisions 1 d and 4 b of this subsection in accordance with 12VAC5-481-2070 R.

B. Safety procedures for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

1. Licensees shall control access to the treatment room by a door at each entrance.

2. Licensees shall equip each entrance to the treatment room with an electrical interlock system that will:

a. Prevent the operator from initiating the treatment cycle unless each treatment room entrance door is closed;

b. Cause the source to be shielded when an entrance door is opened; and

c. Prevent the source from being exposed following an interlock interruption until all treatment room entrance doors are closed and the source on-off console is reset at the console.

3. Licensees shall require any individual entering the treatment room to assure, through the use of appropriate radiation monitors, that radiation levels have returned to ambient levels.

4. Except for low-dose remote afterloader units, licensees shall construct or equip each treatment room with viewing and intercom systems to permit continuous observation of the patient or the human research subject from the treatment console during irradiation.

5. For licensed activities where sources are placed within the patient's or human research subject's body, licensees shall only conduct treatments that allow for expeditious removal of a decoupled or jammed source.

6. In addition to the requirements specified in subdivisions 1 through 5 of this subsection, licensees shall:

a. For medium dose-rate and pulsed dose-rate remote afterloader units, require:

(1) An AMP and either an AU or an physician under the supervision of an AU who has been trained to the operation and emergency response for the unit to be physically present during the initiation of all patient treatments involving the units; and

(2) An AMP and either an AU or an individual under the supervision of an AU who has been trained to remove the source applicators in the event of an emergency involving the unit to be immediately available during the continuation of all patient treatments involving the unit.

b. For high dose-rate remote afterloader units, require:

(1) An AU and an AMP to be physically present during the initiation of all patient treatments involving the unit; and

(2) An AMP and either an AU or a physician under the supervision of an AU who has been trained in the operation and emergency response for the unit to be physically present during continuation of all patient treatments involving the unit.

c. For gamma stereotactic radiosurgery units, require an AU and an AMP to be physically present throughout all patient treatments involving the unit.

d. Notify the RSO, or his designee, and the authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.

7. Licensees shall have applicable emergency response equipment available near each treatment room to respond to a source that:

a. Remains in the unshielded position; or

b. Lodges within the patient following completion of the treatment.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016; amended, Virginia Register Volume 37, Issue 25, eff. January 14, 2022.

12VAC5-481-2044 Dosimetry equipment

A. Except for low dose-rate remote afterloader sources where the source output or activity is determined by the manufacturer, licensees shall have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following two conditions shall be met.

1. The system shall have been calibrated using a system or source traceable to the National Institute of Standards and Technology (NIST) and published protocols accepted by nationally recognized bodies or by a calibration laboratory accredited by the American Association of Physicists in Medicine (AAPM). The calibration shall have been performed within the previous two years and after any servicing that may have affected system calibration; or

2. The system shall have been calibrated within the previous four years. 18 to 30 months after that calibration, the system shall have been intercompared with another dosimetry system that was calibrated within the past 24 months by NIST or by a calibration laboratory accredited by the AAPM. The results of the intercomparison shall indicate that the calibration factor of the licensee's system had not changed by more than 2.0%. The licensee may not use the intercomparison result to change the calibration factor. When intercomparing dosimetry systems to be used for calibrating sealed sources for therapeutic units, the licensee shall use a comparable unit with beam attenuators or collimators, as applicable, and sources of the same radionuclide as the source used at the licensee's facility.

B. Licensees shall have a dosimetry system available for use for spot-check output measurements, if applicable. To satisfy this requirement, the system may be compared with a system that has been calibrated in accordance with subsection A of this section. This comparison shall have been performed within the previous year and after each servicing that may have affected system calibration. The spot-check system may be the same system used to meet the requirement in subsection A of this section.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2045 Full calibration measurements

A. Teletherapy units.

1. Licensees authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit:

a. Before the first medical use of the unit;

b. Before medical use under the following conditions:

(1) Whenever spot-check measurements indicate that the output differs by more than 5.0% from the output obtained at the last full calibration corrected mathematically for radioactive decay;

(2) Following replacement of the source or following reinstallation of the teletherapy unit in a new location; and

(3) Following any repair of the teletherapy unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and

c. At intervals not exceeding one year.

2. To satisfy the requirement of subdivision 1 of this subsection, full calibration measurements shall include determination of:

a. The output within plus or minus 3.0% for the range of field sizes and for the distance or range of distances used for medical use;

b. The coincidence of the radiation field and the field indicated by the light beam localizing device;

c. The uniformity of the radiation field and its dependence on the orientation of the useful beam;

d. Timer accuracy and linearity over the range of use;

e. On-off error; and

f. The accuracy of all distance measuring and localization devices in medical use.

3. Licensees shall use the dosimetry system described in 12VAC5-481-2044 to measure the output for one set of exposure conditions. The remaining radiation measurements required in subdivision 2 a of this subsection may be made using a dosimetry system that indicates relative dose rates.

4. Licensees shall make full calibration measurements required by subdivision 1 of this subsection in accordance with published protocols accepted by nationally recognized bodies.

5. Licensees shall mathematically correct the outputs determined in subdivision 2 a of this subsection for physical decay for intervals not exceeding one month for cobalt-60, six months for cesium-137, or at intervals consistent with 1.0% decay for all other nuclides.

6. Full calibration measurements required by subdivision 1 of this subsection and physical decay corrections required by subdivision 5 of this subsection shall be performed by the authorized medical physicist (AMP).

B. Remote afterloader units.

1. Licensees authorized to use a remote afterloader unit for medical use shall perform full calibration measurements on each unit:

a. Before the first medical use of the unit;

b. Before medical use under the following conditions:

(1) Following replacement of the source or following reinstallation of the unit in a new location outside the facility; and

(2) Following any repair of the unit that includes removal of the source or major repair of the components associated with the source exposure assembly;

c. At intervals not exceeding one quarter for high dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader units with sources whose half-life exceeds 75 days; and

d. At intervals not exceeding one year for low dose-rate remote afterloader units.

2. To satisfy the requirement of subdivision 1 of this subsection, full calibration measurements shall include, as applicable, determination of:

a. The output within plus or minus 5.0%;

b. Source positioning accuracy to within plus or minus 1 millimeter;

c. Source retraction with backup battery upon power failure;

d. Length of the source transfer tubes;

e. Timer accuracy and linearity over the typical range of use;

f. Length of the applicators; and

g. Function of the source transfer tubes, applicators, and transfer tube-applicator interfaces.

3. Licensees shall use the dosimetry system described in 12VAC5-481-2044 to measure the output.

4. Licensees shall make full calibration measurements required by subdivision 1 of this subsection in accordance with published protocols accepted by nationally recognized bodies.

5. In addition to the requirements for full calibrations for low dose-rate remote afterloader units in subdivision 2 of this subsection, licensees shall perform an autoradiograph of the sources to verify inventory and source arrangement at intervals not exceeding one calendar quarter.

6. For low dose-rate remote afterloader units, licensees may use measurements provided by the source manufacturer that are made in accordance with subdivisions 1 through 5 of this subsection.

7. Licensees shall mathematically correct the outputs determined in subdivision 2 a of this subsection for physical decay at intervals consistent with 1.0% physical decay.

8. Full calibration measurements required by subdivision 1 of this subsection and physical decay corrections required by subdivision 7 of this subsection shall be performed by the AMP.

C. Gamma stereotactic radiosurgery units.

1. Licensees authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform full calibration measurements on each unit:

a. Before the first medical use of the unit;

b. Before medical use under the following conditions:

(1) Whenever spot-check measurements indicate that the output differs by more than 5.0% from the output obtained at the last full calibration corrected mathematically for radioactive decay;

(2) Following replacement of the sources or following reinstallation of the gamma stereotactic radiosurgery unit in a new location; and

(3) Following any repair of the gamma stereotactic radiosurgery unit that includes removal of the sources or major repair of the components associated with the source assembly; and

c. At intervals not exceeding one year, with the exception that relative helmet factors need only be determined before the first medical use of a helmet and following any damage to a helmet.

2. To satisfy the requirement of subdivision 1 of this subsection, full calibration measurements shall include determination of:

a. The output within plus or minus 3.0%;

b. Relative helmet factors;

c. Isocenter coincidence;

d. Timer accuracy and linearity over the range of use;

e. On-off error;

f. Trunnion centricity;

g. Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off;

h. Helmet microswitches;

i. Emergency timing circuits; and

j. Stereotactic frames and localizing devices (trunnions).

3. Licensees shall use the dosimetry system described in 12VAC5-481-2044 to measure the output for one set of exposure conditions. The remaining radiation measurements required in subdivision 2 a of this subsection may be made using a dosimetry system that indicates relative dose rates.

4. Licensees shall make full calibration measurements required by subdivision 1 of this subsection in accordance with published protocols accepted by nationally recognized bodies.

5. Licensees shall mathematically correct the outputs determined in subdivision 2 a of this subsection at intervals not exceeding one month for cobalt-60 and at intervals consistent with 1.0% physical decay for all other radionuclides.

6. Full calibration measurements required by subdivision 1 of this subsection and physical decay corrections required by subdivision 5 of this subsection shall be performed by the AMP.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2046 Periodic spot-checks

A. Periodic spot-checks for teletherapy units.

1. Licensees authorized to use teletherapy units for medical use shall perform output spot-checks on each teletherapy unit once in each calendar month that include determination of:

a. Timer accuracy and timer linearity over the range of use;

b. On-off error;

c. The coincidence of the radiation field and the field indicated by the light beam localizing device;

d. The accuracy of all distance measuring and localization devices used for medical use;

e. The output for one typical set of operating conditions measured with the dosimetry system described in 12VAC5-481-2044; and

f. The difference between the measurement made in subdivision 1 e of this subsection and the anticipated output, expressed as a percentage of the anticipated output (i.e. the value obtained at last full calibration corrected mathematically for physical decay).

2. Licensees shall perform measurements required by subdivision 1 of this subsection in accordance with written procedures established by the authorized medical physicist (AMP). That individual need not actually perform the spot-check measurements.

3. Licensees shall have the AMP review the results of each spot-check within 15 days. The shall notify the licensee as soon as possible in writing of the results of each spot-check.

4. Licensees authorized to use a teletherapy unit for medical use shall perform safety spot-checks of each teletherapy facility once in each calendar month and after each source installation to assure proper operation of:

a. Electrical interlocks at each teletherapy room entrance;

b. Electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation (restriction of source housing angulation or elevation, carriage or stand travel, and operation of the beam on-off mechanism);

c. Source exposure indicator lights on the teletherapy unit, on the control console, and in the facility;

d. Viewing and intercom systems;

e. Treatment room doors from inside and outside the treatment room; and

f. Electrically assisted treatment room doors with the teletherapy unit electrical power turned off.

5. If the results of the checks required in subdivision 4 of this subsection indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

B. Periodic spot-checks for remote afterloader units.

1. Licensees authorized to use a remote afterloader unit for medical use shall perform spot-checks of each remote afterloader facility and on each unit:

a. Before the first use of a high dose-rate, medium dose-rate, or pulsed dose-rate remote afterloader unit on a given day;

b. Before each patient treatment with a low dose-rate remote afterloader unit; and

c. After each source installation.

2. Licensees shall perform the measurements required by subdivision 1 of this subsection in accordance with written procedures established by the AMP. That individual need not actually perform the spot-check measurements.

3. Licensees shall have the authorized medical physicist review the results of each spot-check within 15 days. The AMP shall notify the licensee as soon as possible in writing of the results of each spot-check.

4. To satisfy the requirements of subdivision 1 of this subsection, spot-checks shall, at a minimum, assure proper operation of:

a. Electrical interlocks at each remote afterloader unit room entrance;

b. Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility;

c. Viewing and intercom systems in each high dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader facility;

d. Emergency response equipment;

e. Radiation monitors used to indicate the source position;

f. Timer accuracy;

g. Clock (date and time) in the unit's computer; and

h. Decayed sources activity in the unit's computer.

5. If the results of the checks required in subdivision 4 of this subsection indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

C. Periodic spot-checks for gamma stereotactic radiosurgery units.

1. Licensees authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform spot-checks of each gamma stereotactic radiosurgery facility and on each unit:

a. Monthly;

b. Before the first use of the unit on a given day; and

c. After each source installation.

2. Licensees shall:

a. Perform the measurements required by subdivision 1 of this subsection in accordance with written procedures established by the AMP. That individual need not actually perform the spot-check measurements.

b. Have the AMP review the results of each spot-check within 15 days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the results of each spot-check.

3. To satisfy the requirements of subdivision 1 a of this subsection, spot-checks shall, at a minimum:

a. Assure proper operation of:

(1) Treatment table retraction mechanisms, using backup battery power or hydraulic backups with the unit off;

(2) Helmet microswitches;

(3) Emergency timing circuits; and

(4) Stereotactic frames and localizing devices (trunnions).

b. Determine the following:

(1) The output for one typical set of operating conditions measured with the dosimetry system described in 12VAC5-481-2044;

(2) The difference between the measurement made in subdivision 3 b (1) of this subsection and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay);

(3) Source output against computer calculation;

(4) Timer accuracy and linearity over the range of use;

(5) On-off error; and

(6) Trunnion centricity.

4. To satisfy the requirements of subdivisions 1 b and 1 c of this subsection, spot-checks shall assure proper operation of:

a. Electrical interlocks at each gamma stereotactic radiosurgery room entrance;

b. Source exposure indicator lights on the gamma stereotactic radiosurgery unit, on the control console, and in the facility;

c. Viewing and intercom systems;

d. Timer termination;

e. Radiation monitors used to indicate room exposures; and

f. Emergency off buttons.

5. A licensee shall arrange for the repair of any system identified in subdivision 3 of this subsection that is not operating properly as soon as possible.

6. If the results of the checks required in subdivision 4 of this subsection indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2047 Additional technical requirements for mobile remote afterloader units

A. Licensees providing mobile remote afterloader service shall:

1. Check survey instruments before medical use at each address of use or on each day of use, whichever is more frequent; and

2. Account for all sources before departure from a client's address of use.

B. In addition to the periodic spot-checks required by 12VAC5-481-2046, licensees authorized to use a mobile remote afterloader for medical use shall perform checks on each remote afterloader unit before use at each address of use. At a minimum, checks shall be made to verify the operation of:

1. Electrical interlocks on treatment area access points;

2. Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility;

3. Viewing and intercom systems;

4. Applicators, source transfer tubes, and transfer tube-applicator interfaces;

5. Radiation monitors used to indicate room exposures;

6. Source positioning (accuracy); and

7. Radiation monitors used to indicate whether the source has returned to a safe shielded position.

C. In addition to the requirements for checks in subsection B of this section, licensees shall ensure overall proper operation of the remote afterloader unit by conducting a simulated cycle of treatment before use at each address of use.

D. If the results of the checks required in subsection B of this section indicate the malfunction of any system, licensees shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2048 Full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units

A. Licensees shall have each teletherapy unit and gamma stereotactic radiosurgery unit fully inspected and serviced during each source replacement to assure proper functioning of the source exposure mechanism and other safety components. The interval between each full-inspection servicing shall not exceed five years for each teletherapy unit and shall not exceed seven years for each gamma stereotactic radiosurgery unit.

B. This inspection and servicing may only be performed by person specifically licensed to do so by the agency, the NRC, or another Agreement state.

C. Licensees shall keep a record of the inspection and servicing in accordance with 12VAC5-481-2070 X.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016; amended, Virginia Register Volume 37, Issue 25, eff. January 14, 2022.

12VAC5-481-2049 Therapy-related computer systems

Licensees shall perform acceptance testing on the treatment planning system of therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing shall include, as applicable, verification of:

1. The source-specific input parameters required by the dose calculation algorithm;

2. The accuracy of dose, dwell time, and treatment time calculations at representative points;

3. The accuracy of isodose plots and graphic displays;

4. The accuracy of the software used to determine sealed source positions from radiographic images; and

5. The accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016.

Article 10 Training and Experience Requirements

12VAC5-481-2050 (Repealed.)

Article 10 Training and Experience Requirements

History

• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; repealed, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 11 Other Medical Uses of Byproduct Material or Radiation from Byproduct Material

12VAC5-481-2060 Other medical uses of radioactive material or radiation from radioactive materials

Article 11 Other Medical Uses of Byproduct Material or Radiation from Byproduct Material

Licensees may use radioactive material or a radiation source approved for medical use that is not specifically addressed in Articles 3 (12VAC5-481-1700 et seq.) through 9 (12VAC5-481-2040 et seq.) of this part if:

1. The applicant or licensee has submitted the information required by 12VAC5-481-1680; and

2. The applicant or licensee has received written approval from the agency in a license or license amendment and uses the material in accordance with this chapter and specific conditions the agency considers necessary for the medical use of the material.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

Article 12 Records

12VAC5-481-2070 Records

A. Records of authority and responsibilities for radiation protection programs.

1. Licensees shall retain a record of actions taken by the licensee's management in accordance with 12VAC5-481-1700 for five years. The record shall include a summary of the actions taken and a signature of licensee management.

2. Licensees shall retain a copy of both authority, duties, and responsibilities of the RSO as required by 12VAC5-481-1700 and a signed copy of each RSO's agreement to be responsible for implementing the radiation safety program, as required by 12VAC5-481-1700, for the duration of the license. The records shall include the signature of the RSO and licensee management.

3. For each associate radiation safety officer, the licensee shall retain for five years after the associate radiation safety officer is removed from the license, a copy of the written document appointing the associate radiation safety officer signed by licensee's management.

B. Records of radiation protection program changes. Licensees shall retain a record of each radiation protection program change made in accordance with 12VAC5-481-1700 F for five years. The record shall include a copy of the old and new procedures, the effective date of the change, and the signature of the licensee management that reviewed and approved the change.

C. Records of written directives. Licensees shall retain a copy of each written directive as required by 12VAC5-481-1720 for three years.

D. Records for procedures for administrations requiring written directive. Licensees shall retain a copy of the procedures required by 12VAC5-481-1730 for the duration of the license.

E. Records of dosages of unsealed radioactive material for medical use. Licensees shall maintain a record of dosage determinations required by 12VAC5-481-1820 for three years. The record shall contain the radiopharmaceutical; the patient's or human research subject's name or identification number if one has been assigned; the prescribed dosage, the determined dosage, or a notation that the total activity is less than 30 µCi (1.1 MBq); the date and time of dosage determination; and the name of the individual who determined the dosage.

F. Records of leak tests and inventory of sealed sources and brachytherapy sources.

1. Licensees shall retain records of leak tests required by 12VAC5-481-1840 for three years. The records shall include the model number, and the serial number, if one has been assigned, of each source tested; the identity of each source by radionuclide and its estimated activity; the results of the test; the date of the test; and the name of the individual who performed the test.

2. Licensees shall retain records of the semi-annual physical inventory of sealed sources and brachytherapy sources required by 12VAC5-481-1840 for three years. The inventory records shall contain the model number of each source, and serial number of each source if one has been assigned, the identity of each source by radionuclide and its nominal activity, the location of each source, and the name of the individual who performed the inventory.

G. Records of surveys for ambient radiation exposure rate. Licensees shall retain a record of each survey required by 12VAC5-481-1860 for three years. The record shall include the date of the survey, the results of the survey, the instrument used to make the survey, and the name of the individual who performed the survey.

H. Records of the release of individuals containing unsealed radioactive material or implants containing radioactive material.

1. Licensees shall retain a record signed by the authorized user of the basis for authorizing the release of an individual in accordance with 12VAC5-481-1870 for three years after the date of release if the total effective dose equivalent is calculated by:

a. Using the retained activity rather than the activity administered;

b. Using an occupancy factor less than 0.25 at 1 meter;

c. Using the biological or effective half-life; or

d. Considering the shielding by tissue.

2. Licensees shall retain a record for three years after the date of release of the instruction required by 12VAC5-481-1870 that were provided to a breast-feeding female if the radiation dose to the infant or child from continued breast-feeding could result in a total effective dose equivalent exceeding 500 mrem (5 mSv).

I. Records of mobile medical services.

1. Licensees shall retain a copy of each letter that permits the use of radioactive material at the client's address, as required by 12VAC5-481-1880. Each letter shall clearly delineate the authority and responsibility of the licensee and the client and shall be retained for three years after the last provision of service.

2. Licensees shall retain the record of each survey required by 12VAC5-481-1880 for three years. The record shall include the date of the survey, the results of the survey, the instrument used to make the survey, and the name of the individual who performed the survey.

J. Records of decay-in-storage. Licensees shall maintain records of the disposal of licensed materials, as required by 12VAC5-481-1890 for three years. The record shall include the date of the disposal, the survey instrument used, the background radiation level, the radiation level measured at the surface of each waste container, and the name of the individual who performed the survey.

K. Records of molybdenum-99, strontium-82 and strontium-85 concentrations. Licensee shall maintain a record of molybdenum-99 concentration or strontium-82 and stontrium-85 concentration tests required by 12VAC5-481-1930 for three years. The record shall include:

1. For each measured elution of technetium-99m, the ratio of measures expressed as microcuries of molybdenum-99 per millicurie of technetium-99m or kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m, the time and date of the measurement, and the name of the individual who made the measurement; or

2. For each measured elution of rubidium-82, the ratio of the measures expressed as microcurie of strontium-82 per millicurie of rubidium-82 or kilobecquerel of strontium-82 per megabecquerel of rubidium-82, microcurie of strontium-85 per millicurie of rubidium-82 or kilobecquerel of strontium-85 per megabecquerel of rubidium-82, the time and date of the measurement, and the name of the individual who made the measurement.

L. Records of safety instruction. Licensees shall maintain a record of safety instructions and training required by 12VAC5-481-1960 and 12VAC5-481-1970 and the operational and safety instructions required by 12VAC5-481-2013 for three years. Each record shall include a list of topics covered, the date of the instruction or training, the names of the attendees, and the names of the individuals who provided the instruction.

M. Records of surveys after source implant and removal. Licensees shall maintain a record of the surveys required by 12VAC5-481-2011 and 12VAC5-481-2041 for three years. Each record shall include the date and results of the survey, the survey instrument used, and the name of the individual who made the survey.

N. Records of brachytherapy source accountability.

1. Licensee shall maintain a record of brachytherapy source accountability required by 12VAC5-481-2012 for three years.

2. For temporary implants, the record shall include the number and activity of sources removed from storage, the time and date they were removed from storage, the name of the individual who removed them from storage, and the location of use and the number and activity of sources returned to storage, the time and date they were returned to storage, and the name of the individual who returned them to storage.

3. For permanent implants, the record shall include the number and activity of sources removed from storage, the date they were removed from storage, the name of the individual who removed them from storage, the number and activity of sources not implanted, the date they were returned to storage, the name of the individual who returned them to storage, and the number and activity of sources permanently implanted in the patient or human research subject.

O. Records of calibration measurements of brachytherapy sources. Licensees shall maintain a record of the calibrations of brachytherapy sources required by 12VAC5-481-2015 for three years after the last use of the source. The record shall include the date of the calibration; the manufacturer's name, model number and serial number for the source and the instruments used to calibrate the source; the source output or activity; the source positioning accuracy within the applicators; and the name of the individual, the source manufacturer, or the calibration laboratory that performed the calibration.

P. Records of decay of strontrium-90 sources for ophthalmic treatments. Licensees shall maintain a record of the activity of a strontium-90 source required by 12VAC5-481-2016 for the life of the source. The record shall include the date and initial activity of the source as determined under 12VAC5-481-2016, and for each decay calculation, the date and the source activity as determined under 12VAC5-481-2016 and the signature of the authorized medical physicist.

Q. Records of installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units. Licensees shall retain a record of the installation, adjustment, maintenance, and repair of remote afterloaders units, teletherapy units, and gamma stereotactic radiosurgery units as required by 12VAC5-481-2042 for three years. For each installation, adjustment, maintenance, and repair, the record shall include the date, description of the service, and names of the individuals who performed the work.

R. Records of safety procedures. Licensees shall retain a copy of the procedures required by 12VAC5-481-2043 until the licensee no longer possesses the remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit.

S. Records of dosimetry equipment used with remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units. Licensees shall retain a record of the calibration, intercomparison, and comparisons of its dosimetry equipment done in accordance with 12VAC5-481-2044 for the duration of the license. For each calibration, intercomparison, or comparison, the record shall include the date; the manufacturer's name, model numbers, and serial numbers of the instruments that were calibrated, intercompared, or compared as required by 12VAC5-481-2044; the correction factor that was determined from the calibration or comparison or the apparent correction factor that was determined from an intercomparison; and the names of the individuals who performed the calibration, intercomparison, or comparison.

T. Records of teletherapy, remote afterloader, and gamma stereotactic radiosurgery full calibrations. Licensees shall maintain a record of the teletherapy unit, remote afterloader unit, and gamma stereotactic radiosurgery unit full calibrations required by 12VAC5-481-2045 for three years. The record shall include the date of calibration; the manufacturer's name, model number, and serial number of the teletherapy, remote afterloader, and gamma stereotactic radiosurgery unit, the source, and the instruments used to calibrate the unit; the results and an assessment of the full calibrations; the results of the autoradiograph required for low dose-rate remote afterloader units; and the signature of the authorized medical physicist who performed the full calibration.

U. Records of periodic spot-checks for teletherapy units, remote afterloader units, and gamma stereotactic radiosurgery units.

1. Licensees shall retain a record of each periodic spot-check for teletherapy units, remote afterloader units, and gamma stereotactic radiosurgery units required by 12VAC5-481-2046 for three years. The record shall include:

a. For each teletherapy unit; the date of the spot-check, the manufacturer's name, model number, and serial number, source, and instrument used to measure the output of the teletherapy unit; an assessment of timer linearity and constancy; the calculated on-off error; a determination of the coincidence of the radiation field and the field indicated by the light beam localizing device; the determined accuracy of each distance measuring and localization device; the difference between the anticipated output and the measured output; notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each source exposure indicator light, and the viewing and intercom system and doors; the name of the individual who performed the periodic spot-check; and the signature of the authorized medical physicist who reviewed the record of the spot-check.

b. For each remote afterloader unit: the date of the spot-check, the manufacturer's name, model and serial number for the remote afterloader unit and source; an assessment of timer accuracy; notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom systems, and clock and decayed source activity in the unit's computer; the name of the individual who performed the periodic spot-check; and the signature of the authorized medical physicist who reviewed the record of the spot-check.

c. For each gamma stereotactic radiosurgery unit: the date of the spot-check, the manufacturer's name, model number, and serial number for the gamma stereotactic radiosurgery unit and the instrument used to measure the output of the unit; an assessment of timer linearity and accuracy; the calculated on-off error; a determination of trunnion centricity; the difference between the anticipated output and the measured output; an assessment of source output against computer calculations; notations indicating the operability of radiation monitors; helmet microswitches, emergency timing circuits, emergency off buttons, electrical interlocks, source exposure indicator lights, viewing and intercom systems; timer termination, treatment table retraction mechanism, and stereotactic frames and localizing device (trunnions); the name of the individual who performed the periodic spot-check; and the signature of the authorized medical physicist who reviewed the record of the spot-check.

2. Licensees shall retain a copy of the procedures required by 12VAC5-481-2046 A 2, 12VAC5-481-2046 B, and 12VAC5-481-2046 C 2 until the licensee no longer possesses the teletherapy unit, remote afterloader unit, or gamma stereotactic radiosurgery unit.

V. Records of additional technical requirements for mobile remote afterloader units. Licensees shall retain a record of each check for mobile remote afterloader units required by 12VAC5-481-2047 for three years. The record shall include the date of the check, the manufacturer's name, model number, and serial number of the remote afterloader unit; notations accounting for all sources before the licensee departs from a facility; notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom system, applicators, source transfer tubes, and transfer tube applicator interfaces; source positioning accuracy; and the signature of the individual who performed the check.

W. Records of surveys of therapeutic treatment units. Licensees shall maintain a record of radiation surveys of treatment units made in accordance with 12VAC5-481-2041 for the duration of use of the unit. The record shall include the date of the measurements, the manufacturer's name, model number, and serial number of the treatment unit; source and instrument used to measure radiation levels; each dose rate measured around the source while the unit is in the off position and the average of all measurements; and the signature of the individual who performed the test.

X. Records of five-year inspection for teletherapy and gamma stereotactic radiosurgery units. Licensees shall maintain a record of the full-inspection servicing for teletherapy and gamma stereotactic radiosurgery required by 12VAC5-481-2048 for the duration of use of the unit. The record shall include the inspector's radioactive materials license number, the date of inspection, the manufacturer's name, model number, and serial number of both the treatment unit and source, a list of components inspected and serviced, the type of service, and the signature of the inspector.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022.

Article 13 Reports

12VAC5-481-2080 Reports

A. Report and notification of a medical event.

1. Licensees shall report any event as a medical event, except for an event that results from patient intervention, in which the administration of radioactive material or radiation from radioactive material, except permanent implant brachytherapy, results in:

a. A dose that differs from the prescribed dose or dose that would have resulted from the prescribed dosage by more than 5 rem (0.05 Sv) effective dose equivalent, 50 rem (0.5 Sv) to an organ or tissue, or 50 rem (0.5 Sv) shallow dose equivalent to the skin; and

(1) The total dose delivered differs from the prescribed dose by 20% or more;

(2) The total dosage delivered differs from the prescribed dosage by 20% or more or falls outside the prescribed dosage range; or

(3) The fractionated dose delivered differs from the prescribed dose, for a single fraction, by 50% or more.

b. A dose that exceeds 5 rem (0.05 Sv) effective dose equivalent, 50 rem (0.5 Sv) to an organ or tissue, or 50 rem (0.5 Sv) shallow dose equivalent to the skin from any of the following:

(1) An administration of a wrong radioactive drug containing radioactive material or the wrong radionuclide for a brachytherapy procedure;

(2) An administration of a radioactive drug containing radioactive material by the wrong route of administration;

(3) An administration of a dose or dosage to the wrong individual or human research subject;

(4) An administration of a dose or dosage delivered by the wrong mode of treatment; or

(5) A leaking sealed source.

c. A dose to the skin or an organ or tissue other than the treatment site that exceeds by 50 rem (0.5 Sv) or more of the dose expected to that site if the administration had been given in accordance with the written directive prepared or revised before administration and 50% or more the expected dose to that site from the procedure if the administration had been given in accordance with the written directive prepared or revised before administration.

2. For permanent implant brachytherapy, the administration of radioactive material or radiation from radioactive material, excluding sources that were implanted in the correct site but migrated outside the treatment site, that result in the total source strength administered differing by 20% or more from the total source strength documented in the post-implantation portion of the written directive or the total source strength administered outside of the treatment site exceeding 20% of the total source strength documented in the post-implantation of the written directive or an administration involving any of the following: wrong radionuclide, the wrong individual or human research subject, sealed sources implanted directly into a location discontiguous from the treatment site as documented in the post-implantation portion of the written directive, or a leaking sealed source resulting in a dose that exceeds 50 rem (0.5 Sv) to an organ or tissue.

3. Licensees shall report any event resulting from intervention of a patient or human research subject in which the administration of radioactive material or radiation from radioactive material results or will result in unintended permanent functional damage to an organ or a physiological system, as determined by a physician.

4. Licensees shall notify the agency by telephone no later than the next calendar day after discovery of the medical event.

5. By an appropriate method listed in 12VAC5-481-150, licensees shall submit a written report to the agency within 15 days after discovery of the medical event.

a. The written report shall include:

(1) The licensee's name;

(2) The name of the prescribing physician;

(3) A brief description of the event;

(4) Why the event occurred;

(5) The effect, if any, on the individuals who received the administration;

(6) What actions, if any, have been taken or are planned to prevent recurrence; and

(7) Certification that the licensee notified the individual (or the individual's responsible relative or guardian), and if not, why not.

b. The report may not contain the individual's name or any other information that could lead to identification of the individual.

6. Licensees shall provide notification of the event to the referring physician and also notify the individual who is the subject of the medical event no later than 24 hours after its discovery, unless the referring physician personally informs the licensee either that he will inform the individual or that, based on medical judgment, telling the individual would be harmful. Licensees are not required to notify the individual without first consulting the referring physician. If the referring physician or the affected individual cannot be reached within 24 hours, licensees shall notify the individual as soon as possible thereafter. Licensees may not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the medical event, because of any delay in notification. To meet the requirements of this subdivision, the notification of the individual who is the subject of the medical event may be made instead to that individual's responsible relative or guardian. If a verbal notification is made, licensees shall inform the individual, or appropriate responsible relative or guardian, that a written description of the event can be obtained from the licensee upon request. Licensees shall provide such a written description if requested.

7. Aside from the notification requirement, nothing in this section affects any rights or duties of licensees and physicians in relation to each other, to individuals affected by the medical event, or to that individual's responsible relatives or guardians.

8. Licensees shall:

a. Annotate a copy of the report provided to the agency with the:

(1) Name of the individual who is the subject of the event; and

(2) Identification number, or if no other identification number is available, the social security number of the individual who is the subject of the event; and

b. Provide a copy of the annotated report to the referring physician, if other than the licensee, no later than 15 days after the discovery of the event.

B. Report and notification of a dose to an embryo/fetus or a nursing child.

1. Licensees shall report any dose to an embryo/fetus that is greater than 500 mrem (5 mSv) dose equivalent that is a result of an administration of radioactive material or radiation from radioactive material to a pregnant individual unless the dose to the embryo/fetus was specifically approved, in advance, by the authorized user.

2. Licensees shall report any dose to a nursing child that is a result of an administration of radioactive material to a breast-feeding individual that:

a. Is greater than 5 mSv (500 rem) total effective dose equivalent; or

b. Has resulted in unintended permanent functional damage to an organ or a physiological system of the child, as determined by a physician.

3. Licensees shall notify the agency by telephone no later than the next calendar day after discovery of a dose to the embryo/fetus or nursing child that requires a report in accordance with subdivision 1 or 2 in this subsection.

4. By an appropriate method listed in 12VAC5-481-150, licensees shall submit a written report to the agency within 15 days after discovery of a dose to the embryo/fetus or nursing child that requires a report in subdivision 1 or 2 of this subsection.

a. The written report shall include

(1) The licensee's name;

(2) The name of the prescribing physician;

(3) A brief description of the event;

(4) Why the event occurred;

(5) The effect, if any, on the embryo/fetus or the nursing child;

(6) What actions, if any, have been taken or are planned to prevent recurrence; and

(7) Certification that the licensee notified the pregnant individual or mother (or the mother's or child's responsible relative or guardian), and if not, why not.

b. The report shall not contain the individual's or child's name or any other information that could lead to identification of the individual or child.

5. Licensees shall provide notification of the event to the referring physician and also notify the pregnant individual or mother, both hereafter referred to as "mother," no later than 24 hours after discovery of an event that would require reporting under subdivisions 1 or 2 of this subsection, unless the referring physician personally informs the licensee either that the mother will be informed or that, based on medical judgment, telling the mother would be harmful. Licensees are not required to notify the mother without first consulting with the referring physician. If the referring physician or mother cannot be reached within 24 hours, licensees shall make the appropriate notifications as soon as possible thereafter. Licensees may not delay any appropriate medical care for the embryo/fetus or for the nursing child, including any necessary remedial care as a result of the event, because of any delay in notification. To meet the requirements of this subdivision, the notification may be made to the mother's or child's responsible relative or guardian instead of the mother, when appropriate. If a verbal notification is made, licensees shall inform the mother, or the mother's or child's responsible relative or guardian, that a written description of the event can be obtained from the licensee upon request. Licensees shall provide such a written description if requested.

6. Licensees shall:

a. Annotate a copy of the report provided to the agency with the:

(1) Name of the pregnant individual or the nursing child who is the subject of the event; and

(2) Identification number, or if no other identification number is available, the social security number of the pregnant individual or the nursing child who is the subject of the event; and

b. Provide a copy of the annotated report to the referring physician, if other than the licensee, no later than 15 days after the discovery of the event.

C. Report of a leaking source.

1. Licensees shall file a report within five days if a leak test required by 12VAC5-481-1840 reveals the presence of 0.005 µCi (185 Bq) or more of removable contamination.

2. The report shall be filed with the agency by an appropriate method listed in 12VAC5-481-150. The written report shall include:

a. The model number and serial number, if assigned, of the leaking source;

b. The radionuclide and its estimated activity;

c. The results of the test;

d. The date of the test; and

e. The action taken.

D. Report and notification for an eluate exceeding permissible molybdenum-99, strontium-82, and strontium-85 concentrations.

1. Licensees shall notify the agency and the distributor of the generator by telephone within seven calendar days after discovery that an eluate exceeded the permissible concentration listed in 12VAC5-481-1930 A at the time of generator elution. The telephone report to the agency must include the manufacturer, model number, and serial number (or lot number) of the generator; the results of the measurement; the date of the measurement; whether dosages were administered to patients or human research subjects; when the distributor was notified; and the action taken.

2. By an appropriate method listed in 12VAC5-481-150, the licensee shall submit a written report to the agency within 30 calendar days after discovery of an eluate exceeding the permissible concentration at the time of generator elution. The written report shall include the action taken by the licensee; the patient dose assessment; the methodology used to make this dose assessment if the eluate was administered to patients or human research subjects; the probable cause and assessment of failure in the licensee's equipment, procedure, or training that contributed to the excessive readings if an error occurred in the licensee's breakthrough determination; and the information in the telephone report as required by subdivision 1 of this subsection.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022.

12VAC5-481-2090 Purpose and scope

This part provides special requirements for analytical X-ray equipment. The requirements of this part are in addition to, and not in substitution for, applicable requirements in other parts of these regulations.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2100 Equipment requirements

A. Safety device. A device that prevents the entry of any portion of an individual's body into the primary X-ray beam path or that causes the beam to be shut off upon entry into its path shall be provided on all open-beam configurations. A registrant may apply to the agency for an exemption from the requirement of a safety device. Such application shall include:

1. A description of the various safety devices that have been evaluated;

2. The reason each of these devices cannot be used; and

3. A description of the alternative methods that will be employed to minimize the possibility of an accidental exposure, including procedures to assure that operators and others in the area will be informed of the absence of safety devices.

B. Warning devices.

1. Open-beam configurations shall be provided with a readily discernible indication of:

a. X-ray tube "on-off" status located near the radiation source housing, if the primary beam is controlled in this manner; and/or

b. Shutter "open-closed" status located near each port on the radiation source housing, if the primary beam is controlled in this manner.

2. An easily visible warning light labeled with the words "X-RAY ON,"or words having a similar intent, shall be located:

a. Near any switch that energizes an X-ray tube and shall be illuminated only when the tube is energized; or

b. In the case of a radioactive source, near any switch that opens a housing shutter and shall be illuminated only when the shutter is open.

3. Warning devices shall be labeled so that their purpose is easily identified. On equipment installed after September 20, 2006, warning devices shall have fail-safe characteristics.

C. Ports. Unused ports on radiation source housings shall be secured in the closed position in a manner that will prevent casual opening.

D. Labeling. All analytical X-ray equipment shall be labeled with a readily discernible sign or signs bearing the radiation symbol and the words:

1. "CAUTION—HIGH INTENSITY X-RAY BEAM," or words having a similar intent, on the X-ray source housing; and

2. "CAUTION RADIATION—THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED," or words having a similar intent, near any switch that energizes an X-ray tube if the radiation source is an X-ray tube; or

3. "CAUTION—RADIOACTIVE MATERIAL", or words having a similar intent, on the source housing in accordance with 12VAC5-481-660 if the radiation source is a radionuclide.

E. Shutters. On open-beam configurations installed after September 20, 2006, each port on the radiation source housing shall be equipped with a shutter that cannot be opened unless a collimator or a coupling has been connected to the port.

F. Radiation source housing. Each radiation source housing shall be subject to the following requirements:

1. Each X-ray tube housing shall be equipped with an interlock that shuts off the tube if it is removed from the radiation source housing or if the housing is disassembled.

2. Each radioactive source housing or port cover or each X-ray tube housing shall be so constructed that, with all shutters closed, the radiation measured at a distance of five centimeters from its surface is not capable of producing a dose in excess of 2.5 millirems (0.025 mSv) in one hour. For systems utilizing X-ray tubes, this limit shall be met at any specified tube rating.

G. Generator cabinet. Each X-ray generator shall be supplied with a protective cabinet that limits leakage radiation measured at a distance of five centimeters from its surface such that it is not capable of producing a dose in excess of 0.25 millirem (2.5 μSv) in one hour.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2110 Area requirements

A. Radiation Levels. The local components of an analytical x-ray system shall be located and arranged and shall include sufficient shielding or access control such that no radiation levels exist in any area surrounding the local component group that could result in a dose to an individual present therein in excess of the dose limits given in 12VAC5-481-640. For systems utilizing x-ray tubes, these levels shall be met at any specified tube rating.

B. Surveys.

1. Radiation surveys, as required by 12VAC5-481-750, of all analytical x-ray systems sufficient to show compliance with 12VAC5-481-2440 A shall be performed:

a. Upon installation of the equipment, and at least once every five years thereafter by or under the supervision of a private or state inspector who is physically present at the facility during the inspection in order to assure compliance with this chapter;

b. Following any change in the initial arrangement, number, or type of local components in the system;

c. Following any maintenance requiring the disassembly or removal of a local component in the system;

d. During the performance of maintenance and alignment procedures if the procedures require the presence of a primary x-ray beam when any local component in the system is disassembled or removed;

e. Any time a visual inspection of the local components in the system reveals an abnormal condition; and

f. Whenever personnel monitoring devices show a significant increase over the previous monitoring period or the readings are approaching the limits specified in 12VAC5-481-630.

2. Radiation survey measurements shall not be required if a registrant (or licensee) can demonstrate compliance with subsection A of this section to the satisfaction of the agency.

C. Posting. Each area or room containing analytical x-ray equipment shall be conspicuously posted with a sign or signs bearing the radiation symbol and the words "CAUTION—X-RAY EQUIPMENT" or words having a similar intent in accordance with 12VAC5-481-660.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 31, Issue 24, eff. August 27, 2015.

12VAC5-481-2120 Operating requirements

A. Procedures. Normal operating procedures shall be written and available to all analytical X-ray equipment workers. No individual shall be permitted to operate analytical X-ray equipment in any manner other than that specified in the procedures unless such individual has obtained written approval of the radiation safety officer.

B. Bypassing. No individual shall bypass a safety device or interlock unless such individual has obtained the approval of the radiation safety officer. Such approval shall be for a specified period of time. When a safety device or interlock has been bypassed, a readily discernible sign bearing the words "SAFETY DEVICE NOT WORKING", or words having a similar intent, shall be placed on the radiation source housing.

C. Repair or modification of X-ray tube systems. Except as specified in 12VAC5-481-2450 B, no operation involving removal of covers, shielding materials or tube housings or modifications to shutters, collimators, or beam stops shall be performed without ascertaining that the tube is off and will remain off until safe conditions have been restored. The main switch, rather than interlocks, shall be used for routine shutdown in preparation for repairs.

D. Radioactive source replacement, testing, or repair. Radioactive source housings shall be opened for source replacement, leak testing, or other maintenance or repair procedures only by individuals authorized to specifically conduct such procedures under a license issued by the Nuclear Regulatory Commission, an agreement state, or a licensing state.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2130 Personnel requirements

A. Instruction. No individual shall be permitted to operate or maintain analytical X-ray equipment unless such individual has received instruction in and demonstrated competence as to:

1. Identification of radiation hazards associated with the use of the equipment;

2. Significance of the various radiation warning, safety devices, and interlocks incorporated into the equipment, or the reasons they have not been installed on certain pieces of equipment and the extra precautions required in such cases;

3. Proper operating procedures for the equipment;

4. Recognition of symptoms of an acute localized exposure; and

5. Proper procedures for reporting an actual or suspected exposure.

B. Personnel monitoring.

1. Finger or wrist dosimetric devices shall be provided to and shall be used by:

a. Analytical X-ray equipment workers using systems having an open-beam configuration and not equipped with a safety device; and

b. Personnel maintaining analytical X-ray equipment if the maintenance procedures require the presence of a primary X-ray beam when any local component in the analytical X-ray system is disassembled or removed.

2. Reported dose values shall not be used for the purpose of determining compliance with 12VAC5-481-630 of these regulations unless evaluated by a private inspector.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

Article 1 Purpose and Scope

12VAC5-481-2140 Purpose and scope

Article 1 Purpose and Scope

A. This part establishes procedures for the registration and the use of particle accelerators.

B. In addition to the requirements of this part, all registrants are subject to the requirements of Parts I (12VAC5-481-10 et seq.), II (12VAC5-481-260 et seq.), III (12VAC5-481-380 et seq.), IV (12VAC5-481-600 et seq.), and X (12VAC5-481-2250 et seq.) of this chapter. Registrants engaged in industrial radiographic operations are subject to the requirements of Part V (12VAC5-481-1170 et seq.) of this chapter, and registrants engaged in the healing arts are subject to the requirements of Parts VI (12VAC5-481-1580 et seq.) and VII (12VAC5-481-1660 et seq.) of this chapter. Registrants whose operations result in the production of radioactive material are subject to the requirements of Part III (12VAC5-481-380 et seq.) of this chapter.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

Article 2 Registration Procedures

12VAC5-481-2150 Registration requirements

Article 2 Registration Procedures

No person shall receive, possess, use, transfer, own, or acquire a particle accelerator except as authorized in a registration issued pursuant to Part II (12VAC5-481-260 et seq.) or III (12VAC5-481-380 et seq.) of this chapter.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2160 General requirements for the issuance of a registration for particle accelerators

In addition to the requirements of Part II (12VAC5-481-260 et seq.) or III (12VAC5-481-380 et seq.) of this chapter, a registration application for use of a particle accelerator will be approved only if the agency determines that:

1. The applicant is qualified by reason of training and experience to use the accelerator in question for the purpose requested in accordance with this part and Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter in such a manner as to minimize danger to public health and safety or property;

2. The applicant's proposed or existing equipment, facilities, and operating and emergency procedures are adequate to protect health and minimize danger to public health and safety or property;

3. The issuance of the registration will not be inimical to the health and safety of the public, and the applicant satisfies any applicable special requirement in 12VAC5-481-2170;

4. The applicant has appointed a radiation safety officer;

5. The applicant and the applicant's staff have substantial experience in the use of particle accelerators and training sufficient for application to its intended uses;

6. The applicant has established a radiation safety committee to approve, in advance, proposals for uses of particle accelerators, whenever deemed necessary by the agency; and

7. The applicant has an adequate training program for operators of particle accelerators.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2170 Human use of particle accelerators

In addition to the requirements of Part II (12VAC5-481-260 et seq.) of this chapter, a registration for use of a particle accelerator in the healing arts will be issued only if:

1. The applicant has appointed a medical committee of at least three members to evaluate all proposals for research, diagnostic, and therapeutic use of a particle accelerator whenever deemed necessary by the agency. Membership of the committee should include physicians expert in internal medicine, hematology, therapeutic radiology, and a person experienced in depth dose calculations and protection against radiation;

2. The individuals designated on the application as the users have substantial training and experience in deep therapy techniques or in the use of particle accelerators to treat humans; and

3. The individual designated on the application as the user is a physician.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

Article 3 Radiation Safety Requirements for Use of Particle Accelerators

12VAC5-481-2180 Limitations

Article 3 Radiation Safety Requirements for Use of Particle Accelerators

A. No registrant shall permit any individual to act as an operator of a particle accelerator until such individual:

1. Has been instructed in radiation safety and shall have demonstrated an understanding thereof;

2. Has received copies of and instruction in this part and the applicable requirements of Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter, pertinent registration conditions and the registrant's operating and emergency procedures, and shall have demonstrated understanding thereof; and

3. Has demonstrated competence to use the particle accelerator, related equipment, and survey instruments that will be employed.

B. The radiation safety committee or the radiation safety officer shall have the authority to terminate the operations at a particle accelerator facility if such action is deemed necessary to minimize danger to public health and safety or property.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2190 Shielding and safety design requirements

A. A private inspector, acceptable to the agency, shall be consulted in the design of a particle accelerator installation and called upon to perform a radiation survey when the accelerator is first capable of producing radiation.

B. Each particle accelerator installation shall be provided with such primary and secondary barriers as are necessary to assure compliance with 12VAC5-481-630.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2200 Particle accelerator controls and interlock systems

A. Instrumentation, readouts, and controls on the particle accelerator control console shall be clearly identified and easily discernible.

B. Each entrance into a target room or other high radiation area shall be provided with a safety interlock that shuts down the machine under conditions of barrier penetration.

C. Each safety interlock shall be on a circuit that shall allow it to operate independently of all other safety interlocks.

D. All safety interlocks shall be designed so that any defect or component failure in the safety interlock system prevents operation of the accelerator.

E. When a safety interlock system has been tripped, it shall only be possible to resume operation of the accelerator by manually resetting controls at the position where the safety interlock has been tripped and, lastly, at the main control console.

F. A scram button or other emergency power cutoff switch shall be located and easily identifiable in all high radiation areas. Such a cutoff switch shall include a manual reset so that the accelerator cannot be restarted from the accelerator control console without resetting the cutoff switch.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2210 Warning devices

A. Each location designated as a high radiation area, and each entrance to such location, shall be equipped with easily observable warning lights that operate when, and only when, radiation is being produced.

B. Except in facilities designed for human exposure, each high radiation area shall have an audible warning device which shall be activated for 15 seconds prior to the possible creation of such high radiation area. Such warning device shall be clearly discernible in all high radiation areas.

C. Barriers, temporary or otherwise, and pathways leading to high radiation areas shall be posted in accordance with 12VAC5-481-660.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2220 Operating procedures

A. Particle accelerators, when not in operation, shall be secured to prevent unauthorized use.

B. The safety interlock system shall not be used to turn off the accelerator beam except in an emergency.

C. All safety and warning devices, including interlocks, shall be checked for proper operation at intervals not to exceed three months. Results of such tests shall be maintained at the accelerator facility for inspection by the agency.

D. Electrical circuit diagrams of the accelerator and the associated safety interlock systems shall be kept current and maintained for inspection by the agency and shall be available to the operator at each accelerator facility.

E. If, for any reason, it is necessary to intentionally bypass a safety interlock or interlocks, such action shall be:

1. Authorized by the radiation safety committee or radiation safety officer;

2. Recorded in a permanent log and a notice posted at the accelerator control console; and

3. Terminated as soon as possible.

F. A copy of the current operating and the emergency procedures shall be maintained at the accelerator control panel.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2230 Radiation monitoring requirements

A. There shall be available at each particle accelerator facility appropriate portable monitoring equipment that is operable and has been appropriately calibrated for the radiations being produced at the facility. Such equipment shall be tested for proper operation daily and calibrated at intervals not to exceed one year and after each servicing and repair.

B. A radiation survey shall be performed and documented by a private inspector, acceptable to the agency, when changes have been made in shielding, operation, equipment, or occupancy of adjacent areas.

C. Radiation levels in all high radiation areas shall be continuously monitored. The monitoring devices shall be electrically independent of the accelerator control and safety interlock systems and capable of providing a readout at the control panel.

D. All area monitors shall be calibrated at intervals not to exceed one year and after each servicing and repair.

E. Whenever applicable, periodic surveys shall be made to determine the amount of airborne particulate radioactivity present.

F. Whenever applicable, periodic smear surveys shall be made to determine the degree of contamination.

G. All surveys shall be made in accordance with the written procedures established by a private inspector, acceptable to the agency, or the radiation safety officer.

H. Records of all radiation protection surveys, calibrations, and instrumentation tests shall be maintained at the accelerator facility.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2240 Ventilation systems

A. Ventilation systems shall be provided to ensure that personnel entering any area where airborne radioactivity may be produced will not be exposed to airborne radioactive material in excess of those limits specified in Appendix B to 10 CFR Part 20.

B. A registrant, as required in Appendix B to 10 CFR Part 20 shall not vent, release, or otherwise discharge airborne radioactive material to an unrestricted area which exceeds the limits specified in Appendix B to 10 CFR Part 20, except as authorized pursuant to 12VAC5-481-730. For purposes of this subsection concentrations may be averaged over a period not greater than one year. Every effort should be made to maintain releases of radioactive material to unrestricted areas as far below these limits as is reasonably achievable.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2250 Purpose and scope

This part establishes requirements for notices, instructions and reports by licensees or registrants to individuals engaged in activities under a license or registration and options available to such individuals in connection with agency inspections of licensees or registrants to ascertain compliance with the provisions of the Act and regulations, orders, and licenses issued thereunder regarding radiological working conditions. The regulations in this part apply to all persons who receive, possess, use, own, or transfer sources of radiation registered with or licensed by the agency pursuant to Parts II (12VAC5-481-260 et seq.) and III (12VAC5-481-380 et seq.) of this chapter.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2260 Posting of notices to workers

A. Each licensee or registrant shall post current copies of the following documents:

1. The regulations in this part and in Part IV (12VAC5-481-600 et seq.) of this chapter;

2. The license, certificate of registration, conditions or documents incorporated into the license by reference and amendments thereto;

3. The operating procedures applicable to activities under the license or registration;

4. Any notice of violation involving radiological working conditions, proposed imposition of civil penalty, or order issued pursuant to Part I (12VAC5-481-10 et seq.) of this chapter, and any response from the licensee or registrant; and

5. Agency form "Notice to Employees" as required by these regulations.

B. If posting of a document specified in subdivisions A 1 through 3 of this section is not practicable, the licensee or registrant may post a notice that describes the document and states where it may be examined.

C. Agency documents posted pursuant to subdivision A 4 of this section shall be posted within two working days after receipt of the documents from the agency; the licensee's or registrant's response, if any, shall be posted within five working days after dispatch from the licensee or registrant. Such documents shall remain posted for a minimum of five working days or until action correcting the violation has been completed, whichever is later.

D. Documents, notices, or forms posted pursuant to this section shall appear in a sufficient number of places to permit individuals engaged in work under the license or registration to observe them on the way to or from any particular work location to which the document applies, shall be conspicuous, and shall be replaced if defaced or altered.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2270 Instructions to workers

A. All individuals likely to receive in a year an occupational dose in excess of 1 mSv (100 mrem):

1. Shall be kept informed of the storage, transfer, or use of sources of radiation in the licensee's or registrant's workplace;

2. Shall be instructed in the health protection problems associated with exposure to radiation or radioactive material to the individual and potential offspring, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed;

3. Shall be instructed in, and instructed to observe, to the extent within the worker's control, the applicable provisions of these regulations and licenses for the protection of personnel from exposures to radiation or radioactive material;

4. Shall be instructed of their responsibility to report promptly to the licensee or registrant any condition that may constitute, lead to, or cause a violation of the Act, these regulations, or license condition, or any unnecessary exposure to radiation or radioactive material;

5. Shall be instructed in the appropriate response to warnings made in the event of any unusual occurrence or malfunction that may involve exposure to radiation or radioactive material; and

6. Shall be advised as to the radiation exposure reports that workers shall be furnished pursuant to 12VAC5-481-2280.

B. The extent of these instructions shall be commensurate with potential radiological health protection problems present in the workplace.

C. The instructions listed in subsection A of this section shall be given at least annually to said individuals.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2280 Notifications and reports to individuals

A. Radiation exposure data for an individual and the results of any measurements, analyses, and calculations of radioactive material deposited or retained in the body of an individual shall be reported to the individual as specified in this section. The information reported shall include data and results obtained pursuant to these regulations, orders, or license conditions, as shown in records maintained by the licensee or registrant pursuant to 12VAC5-481-1040. Each notification and report shall:

1. Be in writing;

2. Include appropriate identifying data such as the name of the licensee or registrant, the name of the individual, and the individual's identification number;

3. Include the individual's exposure information; and

4. Contain the following statement:

"This report is furnished to you under the provisions of Part X (12VAC5-481-2250 et seq.) of 12VAC5-481, Virginia Radiation Protection Regulations. You should preserve this report for further reference."

B. Each licensee shall make dose information available to workers as shown in records maintained by the licensee under the provisions of 12VAC5-481-1040. The licensee shall provide an annual report to each individual monitored under 12VAC5-481-760 of the dose received in that monitoring year if:

1. The individual's occupational dose exceeds 100 mrem (1 mSv) TEDE or 100 mrem (1 mSv) to any individual organ or tissue; or

2. The individual requests his annual dose report.

C. Each licensee or registrant shall furnish a written report of the worker's exposure to sources of radiation at the request of a worker formerly engaged in activities controlled by the licensee or registrant. The report shall include the dose record for each year the worker was required to be monitored pursuant to 12VAC5-481-760. Such report shall be furnished within 30 days from the date of the request, or within 30 days after the dose of the individual has been determined by the licensee or registrant, whichever is later. The report shall cover the period of time that the worker's activities involved exposure to sources of radiation and shall include the dates and locations of work under the license or registration in which the worker participated during this period.

D. When a licensee or registrant is required pursuant to 12VAC5-481-1100, 12VAC5-481-1110, or 12VAC5-481-1120 to report to the agency any exposure of an individual to sources of radiation, the licensee or the registrant shall also provide the individual a written report on the exposure data included therein. Such reports shall be transmitted at a time not later than the transmittal to the agency.

E. At the request of a worker who is terminating employment with the licensee or registrant in work involving exposure to radiation or radioactive material, during the current year, each licensee or registrant shall provide at termination to each such worker, or to the worker's designee, a written report regarding the radiation dose received by that worker from operations of the licensee or registrant during the current year or fraction thereof. If the most recent individual monitoring results are not available at that time, a written estimate of the dose shall be provided together with a clear indication that this is an estimate.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2290 Presence of representatives of licensees or registrants and workers during inspection

A. Each licensee or registrant shall afford to the agency at all reasonable times opportunity to inspect materials, machines, activities, facilities, premises, and records pursuant to these regulations.

B. During an inspection, agency inspectors may consult privately with workers as specified in 12VAC5-481-2300. The licensee or registrant may accompany agency inspectors during other phases of an inspection.

C. If, at the time of inspection, an individual has been authorized by the workers to represent them during agency inspections, the licensee or registrant shall notify the inspectors of such authorization and shall give the workers' representative an opportunity to accompany the inspectors during the inspection of physical working conditions.

D. Each workers' representative shall be routinely engaged in work under control of the licensee or registrant and shall have received instructions as specified in 12VAC5-481-2270.

E. Different representatives of licensees or registrants and workers may accompany the inspectors during different phases of an inspection if there is no resulting interference with the conduct of the inspection. However, only one workers' representative at a time may accompany the inspectors.

F. With the approval of the licensee or registrant and the workers' representative, an individual who is not routinely engaged in work under control of the licensee or registrant, for example, a consultant to the licensee or registrant or to the workers' representative, shall be afforded the opportunity to accompany agency inspectors during the inspection of physical working conditions.

G. Notwithstanding the other provisions of 12VAC5-481-2290, agency inspectors are authorized to refuse to permit accompaniment by any individual who deliberately interferes with a fair and orderly inspection. With regard to areas containing information classified by an agency of the United States government in the interest of national security, an individual who accompanies an inspector may have access to such information only if authorized to do so. With regard to any area containing proprietary information, the workers' representative for that area shall be an individual previously authorized by the licensee or registrant to enter that area.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2300 Consultation with workers during inspections

A. Agency inspectors may consult privately with workers concerning matters of occupational radiation protection and other matters related to applicable provisions of these regulations and licenses to the extent the inspectors deem necessary for the conduct of an effective and thorough inspection.

B. During the course of an inspection, any worker may bring privately to the attention of the inspectors, either orally or in writing, any past or present condition that the worker has reason to believe may have contributed to or caused any violation of the Act, these regulations, or license condition, or any unnecessary exposure of an individual to sources of radiation under the licensee's or registrant's control. Any such notice in writing shall comply with the requirements of 12VAC5-481-2310 A.

C. The provisions of subsection B of this section shall not be interpreted as authorization to disregard instructions pursuant to 12VAC5-481-2270.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2310 Requests by workers for inspections

A. Any worker or representative of workers believing that a violation of the Act, these regulations, or license conditions exists or has occurred in work under a license or registration with regard to radiological working conditions in which the worker is engaged may request an inspection by giving notice of the alleged violation to the agency. Any such notice shall be in writing, shall set forth the specific grounds for the notice, and shall be signed by the worker or representative of the workers. A copy shall be provided to the licensee or registrant by the agency no later than at the time of inspection except that, upon the request of the worker giving such notice, such worker's name and the name of individuals referred to therein shall not appear in such copy or on any record published, released, or made available by the agency, except for good cause shown.

B. If, upon receipt of such notice, the agency determines that the complaint meets the requirements set forth in subsection A of this section, and that there are reasonable grounds to believe that the alleged violation exists or has occurred, an inspection shall be made as soon as practicable to determine if such alleged violation exists or has occurred. Inspections pursuant to this section need not be limited to matters referred to in the complaint.

C. No licensee, registrant, or contractor or subcontractor of a licensee or registrant shall discharge or in any manner discriminate against any worker because such worker has filed any complaint or instituted or caused to be instituted any proceeding under these regulations or has testified or is about to testify in any such proceeding or because of the exercise by such worker on behalf of such worker or others of any option afforded by this part.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2320 Inspections not warranted; informal review

A. Do the following:

1. If the agency determines, with respect to a complaint under 12VAC5-481-2310, that an inspection is not warranted because there are no reasonable grounds to believe that a violation exists or has occurred, the agency shall notify the complainant in writing of such determination. The complainant may obtain review of such determination by submitting a written statement of position with the agency. The agency will provide the licensee or registrant with a copy of such statement by certified mail, excluding, at the request of the complainant, the name of the complainant. The licensee or registrant may submit an opposing written statement of position with the agency. The agency will provide the complainant with a copy of such statement by certified mail.

2. Upon the request of the complainant, the agency may hold an informal conference in which the complainant and the licensee or registrant may orally present their views. An informal conference may also be held at the request of the licensee or registrant, but disclosure of the identity of the complainant will be made only following receipt of written authorization from the complainant. After considering all written and oral views presented, the agency shall affirm, modify, or reverse the determination of the agency and furnish the complainant and the licensee or registrant a written notification of the decision and the reason therefor.

B. If the agency determines that an inspection is not warranted because the requirements of 12VAC5-481-2310 A have not been met, the complainant shall be notified in writing of such determination. Such determination shall be without prejudice to the filing of a new complaint meeting the requirements of 12VAC5-481-2310 A.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

Article 1 Purpose and Scope

12VAC5-481-2330 Purpose and scope

Article 1 Purpose and Scope

A. The regulations in this part establish procedures, criteria, and terms and conditions upon which the agency issues licenses for the land disposal of wastes received from other persons. The requirements of this part are in addition to, and not in substitution for, other applicable requirements of these regulations.

B. The regulations in this part do not apply to disposal of byproduct material as defined in the definition of "byproduct material" in these regulations in quantities greater than 10,000 kilograms containing more than 185 MBq (5 mCi) of radium-226 or disposal of radioactive material as provided for in Part IV (12VAC5-481-600 et seq.) of this chapter.

C. This part establishes procedural requirements and performance objectives applicable to any method of land disposal. It establishes specific technical requirements for near-surface disposal of radioactive waste that involves disposal in the uppermost portion of the earth.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 2 General Regulatory Provisions

12VAC5-481-2340 License required

Article 2 General Regulatory Provisions

A. No person may receive, possess, and dispose of waste received from other persons at a land disposal facility unless authorized by a license issued by the agency pursuant to this part and Part III (12VAC5-481-380 et seq.) of this chapter.

B. Each person shall file an application with the agency pursuant to 12VAC5-481-440 and obtain a license as provided in this part before commencement of construction of a land disposal facility. Failure to comply with this requirement may be grounds for denial of a license.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2350 Content of application

In addition to the requirements set forth in 12VAC5-481-450, an application to receive from others, possess, and dispose of wastes shall consist of general information, specific technical information, institutional information, and financial information as set forth in 12VAC5-481-2360 through 12VAC5-481-2400.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2360 General information

The general information shall include each of the following:

1. Identity of the applicant including:

a. The full name, address, telephone number, and description of the business or occupation of the applicant;

b. If the applicant is a partnership, the name and address of each partner and the principal location where the partnership does business;

c. If the applicant is a corporation or an unincorporated association, (i) the state where it is incorporated or organized and the principal location where it does business, and (ii) the names and addresses of its directors and principal officers; and

d. If the applicant is acting as an agent or representative of another person in filing the application, all information required under this subsection must be supplied with respect to the other person.

2. Qualifications of the applicant:

a. The organizational structure of the applicant, both offsite and onsite, including a description of lines of authority and assignments of responsibilities, whether in the form of administrative directives, contract provisions, or otherwise;

b. The technical qualifications, including training and experience, of the applicant and members of the applicant's staff to engage in the proposed activities. Minimum training and experience requirements for personnel filling key positions described in subdivision 2 a of this section must be provided.

c. A description of the applicant's personnel training program; and

d. The plan to maintain an adequate complement of trained personnel to carry out waste receipt, handling, and disposal operations in a safe manner.

3. A description of:

a. The location of the proposed disposal site;

b. The general character of the proposed activities;

c. The types and quantities of waste to be received, possessed, and disposed of;

d. Plans for use of the land disposal facility for purposes other than disposal of wastes; and

e. The proposed facilities and equipment.

4. Proposed schedules for construction, receipt of waste, and first emplacement of waste at the proposed land disposal facility.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2370 Specific technical information

The specific technical information shall include the following information needed for demonstration that the performance objectives and the applicable technical requirements of this part will be met:

1. A description of the natural and demographic disposal site characteristics as determined by disposal site selection and characterization activities. The description shall include geologic, geochemical, geotechnical, hydrologic, ecologic, archaelogic, meteorologic, climatologic, and biotic features of the disposal site and vicinity.

2. A description of the design features of the land disposal facility and the disposal units. For near-surface disposal, the description shall include those design features related to infiltration of water; integrity of covers for disposal units; structural stability of backfill, wastes, and covers; contact of wastes with standing water; disposal site drainage; disposal site closure and stabilization; elimination to the extent practicable of long-term disposal site maintenance; inadvertent intrusion; occupational exposures; disposal site monitoring; and adequacy of the size of the buffer zone for monitoring and potential mitigative measures.

3. A description of the principal design criteria and their relationship to the performance objectives.

4. A description of the design basis natural events or phenomena and their relationship to the principal design criteria.

5. A description of codes and standards that the applicant has applied to the design and that will apply to construction of the land disposal facilities.

6. A description of the construction and operation of the land disposal facility. The description shall include as a minimum the methods of construction of disposal units; waste emplacement; the procedures for and areas of waste segregation; types of intruder barriers; onsite traffic and drainage systems; survey control program; methods and areas of waste storage; and methods to control surface water and groundwater access to the wastes. The description shall also include a description of the methods to be employed in the handling and disposal of wastes containing chelating agents or other nonradiological substances that might affect meeting the performance objectives of this part.

7. A description of the disposal site closure plan, including those design features that are intended to facilitate disposal site closure and to eliminate the need for ongoing active maintenance.

8. An identification of the known natural resources at the disposal site, whose exploitation could result in inadvertent intrusion into the wastes after removal of active institutional control.

9. A description of the kind, amount, classification and specifications of the radioactive material proposed to be received, possessed, and disposed of at the land disposal facility.

10. A description of the quality control program for the determination of natural disposal site characteristics and for quality control during the design, construction, operation, and closure of the land disposal facility and the receipt, handling, and emplacement of waste. Audits and managerial controls must be included.

11. A description of the radiation safety program for control and monitoring of radioactive effluents to ensure compliance with the performance objective in 12VAC5-481-2490 and occupational radiation exposure to ensure compliance with the requirements of Part IV (12VAC5-481-600 et seq.) of this chapter and to control contamination of personnel, vehicles, equipment, buildings, and the disposal site. Both routine operations and accidents shall be addressed. The program description must include procedures, instrumentation, facilities, and equipment.

12. A description of the environmental monitoring program to provide data to evaluate potential health and environmental impacts and the plan for taking corrective measures if migration is indicated.

13. A description of the administrative procedures that the applicant will apply to control activities at the land disposal facility.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2380 Technical analyses

The specific technical information shall also include the following analyses needed to demonstrate that the performance objectives of this part will be met:

1. Pathways analyzed in demonstrating protection of the general population from releases of radioactivity shall include air, soil, groundwater, surface water, plant uptake, and exhumation by burrowing animals. The analyses shall clearly identify and differentiate between the roles performed by the natural disposal site characteristics and design features in isolating and segregating the wastes. The analyses shall clearly demonstrate that there is reasonable assurance that the exposures to humans from the release of radioactivity will not exceed the limits set forth in 12VAC5-481-2490.

2. Analyses of the protection of individuals from inadvertent intrusion shall include demonstration that there is reasonable assurance the waste classification and segregation requirements will be met and that adequate barriers to inadvertent intrusion will be provided.

3. Analyses of the protection of individuals during operations shall include assessments of expected exposures due to routine operations and likely accidents during handling, storage, and disposal of waste. The analyses shall provide reasonable assurance that exposures will be controlled to meet the requirements of Part IV (12VAC5-481-600 et seq.) of this chapter.

4. Analyses of the long-term stability of the disposal site and the need for ongoing active maintenance after closure shall be based upon analyses of active natural processes such as erosion, mass wasting, slope failure, settlement of wastes and backfill, infiltration through covers over disposal areas and adjacent soils, and surface drainage of the disposal site. The analyses shall provide reasonable assurance that there will not be a need for ongoing active maintenance of the disposal site following closure.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2390 Institutional information

The institutional information submitted by the applicant shall include:

1. A certification by the federal or state agency that owns the disposal site that the federal or state agency is prepared to accept transfer of the license when the provisions of 12VAC5-481-2460 are met and will assume responsibility for institutional control after site closure and post-closure observation and maintenance.

2. Where the proposed disposal site is on land not owned by the federal or a state government, the applicant shall submit evidence that arrangements have been made for assumption of ownership in fee by the federal or a state agency before the agency issues a license.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2400 Financial information

The financial information shall be sufficient to demonstrate that the financial qualifications of the applicant are adequate to carry out the activities for which the license is sought and meet other financial assurance requirements of this part.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2410 Requirements for issuance of a license

A license for the receipt, possession, and disposal of waste containing or contaminated with radioactive material will be issued by the agency upon finding that:

1. The issuance of the license will not constitute an unreasonable risk to the health and safety of the public;

2. The applicant is qualified by reason of training and experience to carry out the disposal operations requested in a manner that protects health and minimizes danger to life or property;

3. The applicant's proposed disposal site, disposal design, land disposal facility operations, including equipment, facilities, and procedures, disposal site closure, and post-closure institutional control are adequate to protect the public health and safety in that they provide reasonable assurance that the general population will be protected from releases of radioactivity as specified in the performance objective in 12VAC5-481-2490;

4. The applicant's proposed disposal site, disposal site design, land disposal facility operations, including equipment, facilities, and procedures, disposal site closure, and post-closure institutional control are adequate to protect the public health and safety in that they will provide reasonable assurance that individual inadvertent intruders are protected in accordance with the performance objective in 12VAC5-481-2520;

5. The applicant's proposed land disposal facility operations, including equipment, facilities, and procedures, are adequate to protect the public health and safety in that they will provide reasonable assurance that the standards for radiation protection set out in Part IV (12VAC5-481-600 et seq.) of this chapter will be met;

6. The applicant's proposed disposal site, disposal site design, land disposal facility operations, disposal site closure, and post-closure institutional control are adequate to protect the public health and safety in that they will provide reasonable assurance that long-term stability of the disposed waste and the disposal site will be achieved and will eliminate to the extent practicable the need for ongoing active maintenance of the disposal site following closure;

7. The applicant's demonstration provides reasonable assurance that the applicable technical requirements of this part will be met;

8. The applicant's proposal for institutional control provides reasonable assurance that such control will be provided for the length of time found necessary to ensure the findings in subdivisions 3 through 6 of this section and that the institutional control meets the requirements of 12VAC5-481-2580; and

9. The financial or surety arrangements meet the requirements of this part.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2420 Conditions of licenses

A. A license issued under this part, or any right thereunder, may be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of the license to any person, only if the agency finds, after securing full information, that the transfer is in accordance with the provisions of the Act and gives its consent in writing in the form of a license amendment.

B. The licensee shall submit written statements under oath upon request of the agency, at any time before termination of the license, to enable the agency to determine whether the license should be modified, suspended, or revoked.

C. The license will be terminated only on the full implementation of the final closure plan as approved by the agency, including post-closure observation and maintenance.

D. The licensee shall be subject to the provisions of the Act now or hereafter in effect, and to all rules, regulations, and orders of the agency. The terms and conditions of the license are subject to amendment, revision, or modification, by reason of amendments to, or by reason of rules, regulations, and orders issued in accordance with the terms of the Act.

E. Each person licensed by the agency pursuant to the regulations in this part shall confine possession and use of materials to the locations and purposes authorized in the license.

F. The licensee shall not dispose of waste until the agency has inspected the land disposal facility and has found it to be in conformance with the description, design, and construction described in the application for a license.

G. The agency may incorporate in any license at the time of issuance, or thereafter, by appropriate rule, regulation or order, additional requirements and conditions with respect to the licensee's receipt, possession, and disposal of waste as it deems appropriate or necessary in order to:

1. Protect health or to minimize danger to life or property;

2. Require reports and the keeping of records, and to provide for inspections of activities under the license that may be necessary or appropriate to effectuate the purposes of the Act and regulations thereunder.

H. The authority to dispose of wastes expires on the date stated in the license. Any expiration date on a license applies only to the above ground activities and to the authority to dispose of waste. Failure to renew the license shall not relieve the licensee of responsibility for implementing site closure, post-closure observation, and transfer of the license to the site owner.

I. Each licensee shall notify the agency in writing immediately following the filing of a voluntary or involuntary petition for bankruptcy under any Chapter of Title 11 (Bankruptcy) of the United States Code by or against:

1. The licensee;

2. An entity (as that term is defined in 11 USC § 101(15)) controlling the licensee or listing the license or licensee as property of the estate; or

3. An affiliate (as that term is defined in 11 USC § 101(2)) of the licensee.

J. The notification specified in this section shall indicate the bankruptcy court in which the petition for bankruptcy was filed and the date of the filing of the petition.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2430 Application for renewal or closure

A. An application for renewal or an application for closure under 12VAC5-481-2440 must be filed at least 90 days prior to license expiration.

B. Applications for renewal of a license must be filed in accordance with 12VAC5-481-2350 through 12VAC5-481-2400. Applications for closure must be filed in accordance with 12VAC5-481-2440.

C. In any case in which a licensee has filed an application in proper form for renewal of a license, the license does not expire until the agency has taken final action on the application for renewal.

D. In determining whether a license will be renewed, the agency will apply the criteria set forth in 12VAC5-481-2410.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2440 Contents of application for site closure and stabilization

A. Prior to final closure of the disposal site, or as otherwise directed by the agency, the applicant shall submit an application to amend the license for closure. This closure application shall include a final revision and specific details of the disposal site closure plan included as part of the license application submitted under subdivision 7 of 12VAC5-481-2370 that includes each of the following:

1. Any additional geologic, hydrologic, or other data pertinent to the long-term containment of emplaced wastes obtained during the operational period.

2. The results of tests, experiments, or any other analyses relating to backfill of excavated areas, closure and sealing, waste migration and interaction with emplacement media, or any other tests, experiments, or analysis pertinent to the long-term containment of emplaced waste within the disposal site.

3. Any proposed revision of plans for:

a. Decontamination and/or dismantlement of surface facilities;

b. Backfilling of excavated areas; or

c. Stabilization of the disposal site for post-closure care.

4. Any significant new information regarding the environmental impact of closure activities and long-term performance of the disposal site.

B. Upon review and consideration of an application to amend the license for closure submitted in accordance with subsection A of this section, the agency shall issue an amendment authorizing closure if there is reasonable assurance that the long-term performance objectives of this part will be met.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2450 Post-closure observation and maintenance

The licensee shall observe, monitor, and carry out necessary maintenance and repairs at the disposal site until the site closure is complete and the license is transferred by the agency in accordance with 12VAC5-481-2460. Responsibility for the disposal site must be maintained by the licensee for five years. A shorter or longer time period for post-closure observation and maintenance may be established and approved as part of the site closure plan, based on site-specific conditions.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2460 Transfer of license

Following closure and the period of post-closure observation and maintenance, the licensee may apply for an amendment to transfer the license to the disposal site owner. The license shall be transferred when the agency finds:

1. That the closure of the disposal site has been made in conformance with the licensee's disposal site closure plan, as amended and approved as part of the license;

2. That reasonable assurance has been provided by the licensee that the performance objectives of this part are met;

3. That any funds and necessary records for care will be transferred to the disposal site owner;

4. That the post-closure monitoring program is operational for implementation by the disposal site owner; and

5. That the federal or state agency that will assume responsibility for institutional control of the disposal site is prepared to assume responsibility and ensure that the institutional requirements found necessary under subdivision 8 of 12VAC5-481-2410 will be met.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2470 Termination of license

A. Following any period of institutional control needed to meet the requirements found necessary under 12VAC5-481-2410, the licensee may apply for an amendment to terminate the license.

B. This application will be reviewed in accordance with the provisions of 12VAC5-481-450.

C. A license shall be terminated only when the agency finds:

1. That the institutional control requirements found necessary under 12VAC5-481-2410 8 have been met;

2. That any additional requirements resulting from new information developed during the institutional control period have been met; and

3. That permanent monuments or markers warning against intrusion have been installed.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 3 General Performance Objectives

12VAC5-481-2480 General requirement

Article 3 General Performance Objectives

Land disposal facilities shall be sited, designed, operated, closed, and controlled after closure so that reasonable assurance exists that exposures to individuals are within the requirements established in the performance objectives in 12VAC5-481-2490 through 12VAC5-481-2520.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2490 Protection of the general population from releases of radioactivity

Concentrations of radioactive material that may be released to the general environment in ground water, surface water, air, soil, plants, or animals shall not result in an annual dose exceeding an equivalent of 0.25 mSv (25 mrem) to the whole body, 0.75 mSv (75 mrem) to the thyroid, and 0.25 mSv (25 mrem) to any other organ of any member of the public. Reasonable effort should be made to maintain releases of radioactivity in effluents to the general environment ALARA.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2500 Protection of individuals from inadvertent intrusion

Design, operation, and closure of the land disposal facility shall ensure protection of any individual inadvertently intruding into the disposal site and occupying the site or contacting the waste at any time after active institutional controls over the disposal site are removed.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2510 Protection of individuals during operations

Operations at the land disposal facility shall be conducted in compliance with the standards for radiation protection set out in Part IV (12VAC5-481-600 et seq.) of this chapter, except for releases of radioactivity in effluents from the land disposal facility, that shall be governed by 12VAC5-481-2490. Every reasonable effort should be made to maintain radiation exposures ALARA.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2520 Stability of the disposal site after closure

The disposal facility shall be sited, designed, used, operated, and closed to achieve long-term stability of the disposal site and to eliminate, to the extent practicable, the need for ongoing active maintenance of the disposal site following closure so that only surveillance, monitoring, or minor custodial care are required.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

Article 4 Technical Requirements for Land Disposal Facilities

12VAC5-481-2530 Disposal site suitability requirements for land disposal

Article 4 Technical Requirements for Land Disposal Facilities

Disposal site suitability for near-surface disposal. The primary emphasis in disposal site suitability is given to isolation of wastes and to disposal site features that ensure that the long-term performance objectives are met.

1. The disposal site shall be capable of being characterized, modeled, analyzed and monitored.

2. Within the region where the facility is to be located, a disposal site should be selected so that projected population growth and future developments are not likely to affect the ability of the disposal facility to meet the performance objectives of this part.

3. Areas shall be avoided having known natural resources which, if exploited, would result in failure to meet the performance objectives of this part.

4. The disposal site shall be generally well drained and free of areas of flooding or frequent ponding. Waste disposal shall not take place in a 100-year flood plain, coastal high-hazard area or wetland, as defined in federal Executive Order 11988, "Floodplain Management Guidelines."

5. Upstream drainage areas shall be minimized to decrease the amount of runoff which could erode or inundate waste disposal units.

6. The disposal site shall provide sufficient depth to the water table that ground water intrusion, perennial or otherwise, into the waste will not occur. The agency will consider an exception to this requirement to allow disposal below the water table if it can be conclusively shown that disposal site characteristics will result in molecular diffusion being the predominant means of radionuclide movement and the rate of movement will result in the performance objectives being met. In no case will waste disposal be permitted in the zone of fluctuation of the water table.

7. The hydrogeologic unit used for disposal shall not discharge ground water to the surface within the disposal site.

8. Areas shall be avoided where tectonic processes such as faulting, folding, seismic activity, or vulcanism may occur with such frequency and extent to significantly affect the ability of the disposal site to meet the performance objectives of this part or may preclude defensible modeling and prediction of long-term impacts.

9. Areas shall be avoided where surface geologic processes such as mass wasting, erosion, slumping, landsliding, or weathering occur with such frequency and extent to significantly affect the ability of the disposal site to meet the performance objectives of this part, or may preclude defensible modeling and prediction of long-term impacts.

10. The disposal site must not be located where nearby facilities or activities could adversely impact the ability of the site to meet the performance objectives of this part or significantly mask the environmental monitoring program.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2540 Disposal site design for land disposal

Disposal site design for near-surface disposal.

1. Site design features shall be directed toward long-term isolation and avoidance of the need for continuing active maintenance after site closure.

2. The disposal site design and operation shall be compatible with the disposal site closure and stabilization plan and lead to disposal site closure that provides reasonable assurance that the performance objectives will be met.

3. The disposal site shall be designed to complement and improve, where appropriate, the ability of the disposal site's natural characteristics to assure that the performance objectives will be met.

4. Covers shall be designed to minimize to the extent practicable water infiltration, to direct percolating or surface water away from the disposed waste, and to resist degradation by surface geologic processes and biotic activity.

5. Surface features shall direct surface water drainage away from disposal units at velocities and gradients that will not result in erosion that will require ongoing active maintenance in the future.

6. The disposal site shall be designed to minimize to the extent practicable the contact of water with waste during storage, the contact of standing water with waste during disposal, and the contact of percolating or standing water with wastes after disposal.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2550 Land disposal facility operation and disposal site closure

Near-surface disposal facility operation and disposal site closure.

1. Wastes designated as Class A pursuant to these regulations shall be segregated from other wastes by placing in disposal units which are sufficiently separated from disposal units for the other waste classes so that any interaction between Class A wastes and other wastes will not result in the failure to meet the performance objectives of this part. This segregation is not necessary for Class A wastes if they meet the stability requirements of these regulations.

2. Wastes designated as Class C pursuant to these regulations shall be disposed of so that the top of the waste is a minimum of 5 meters below the top surface of the cover or must be disposed of with intruder barriers that are designed to protect against an inadvertent intrusion for at least 500 years.

3. Except as provided in subdivision 12 of this subsection, only waste classified as Class A, B, or C shall be acceptable for near-surface disposal. All waste shall be disposed of in accordance with requirements of 4 through 11 of this subsection.

4. Wastes shall be emplaced in a manner that maintains the package integrity during emplacement, minimizes the void spaces between packages, and permits the void spaces to be filled.

5. Void spaces between waste packages shall be filled with earth or other material to reduce future subsidence within the fill.

6. Waste shall be placed and covered in a manner that limits the radiation dose rate at the surface of the cover to levels that at a minimum will permit the licensee to comply with all provisions of 12VAC5-481-640 at the time the license is transferred pursuant to 12VAC5-481-2460.

7. The boundaries and locations of each disposal unit shall be accurately located and mapped by means of a land survey. Near-surface disposal units shall be marked in such a way that the boundaries of each unit can be easily defined. Three permanent survey marker control points, referenced to United States Geological Survey (USGS) or National Geodetic Survey (NGS) survey control stations, shall be established on the site to facilitate surveys. The USGS or NGS control stations shall provide horizontal and vertical controls as checked against USGS or NGS record files.

8. A buffer zone of land shall be maintained between any buried waste and the disposal site boundary and beneath the disposed waste. The buffer zone shall be of adequate dimensions to carry out environmental monitoring activities specified in 12VAC5-481-2560 C and take mitigative measures if needed.

9. Closure and stabilization measures as set forth in the approved site closure plan shall be carried out as each disposal unit is filled and covered.

10. Active waste disposal operations shall not have an adverse effect on completed closure and stabilization measures.

11. Only wastes containing or contaminated with radioactive material shall be disposed of at the disposal site.

12. Proposals for disposal of waste that is not generally acceptable for near-surface disposal because the waste form and disposal methods must be different and, in general, more stringent than those specified for Class C waste, may be submitted to the agency for approval.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2560 Environmental monitoring

A. At the time a license application is submitted, the applicant shall have conducted a preoperational monitoring program to provide basic environmental data on the disposal site characteristics. The applicant shall obtain information about the ecology, meteorology, climate, hydrology, geology including geophysics and geotechnical engineering, geochemistry, and seismology of the disposal site. For those characteristics that are subject to seasonal variation, data must cover at least a 12-month period.

B. During the land disposal facility site construction and operation, the licensee shall maintain an environmental monitoring program. Measurements and observations must be made and recorded to provide data to evaluate the potential health and environmental impacts during both the construction and the operation of the facility and to enable the evaluation of long-term effects and the need for mitigative measures. The monitoring system must be capable of providing early warning of releases of waste from the disposal site before they leave the site boundary.

C. After the disposal site is closed, the licensee responsible for post-operational surveillance of the disposal site shall maintain a monitoring system based on the operating history and the closure and stabilization of the disposal site. The monitoring system must be capable of providing early warning of releases of waste from the disposal site before they leave the site boundary.

D. The licensee shall have plans for taking corrective measures if the environmental monitoring program detects migration of waste which would indicate that the performance objectives may not be met.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2570 Alternative requirements for design and operations

The agency may, upon request or on its own initiative, authorize provisions other than those set forth in 12VAC5-481-2540 through 12VAC5-481-2560 for the segregation and disposal of waste and for the design and operation of a land disposal facility on a specific basis, if it finds reasonable assurance of compliance with the performance objectives of this part.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2571 Waste classification

A. Considerations. Determination of the classification of radioactive waste involves two considerations. First, consideration must be given to the concentration of long-lived radionuclides (and their shorter-lived precursors) whose potential hazard will persist long after such precautions as institutional controls, improved waste form, and deeper disposal have ceased to be effective. These precautions delay the time when long-lived radionuclides could cause exposures. In addition, the magnitude of the potential dose is limited by the concentration and availability of the radionuclide at the time of exposure. Second, consideration must be given to the concentration of shorter-lived radionuclides for which requirements on institutional controls, waste form, and disposal methods are effective.

B. Classes of waste.

1. Class A waste is waste that is usually segregated from other waste classes at the disposal site. The physical form and characteristics of Class A waste must meet the minimum requirements set forth in 12VAC5-481-2572 A. If Class A waste also meets the stability requirements set forth in 12VAC5-481-2572 B, it is not necessary to segregate the waste for disposal.

2. Class B waste is waste that must meet more rigorous requirements on waste form to ensure stability after disposal. The physical form and characteristics of Class B waste must meet both the minimum and stability requirements set forth in 12VAC5-481-2572.

3. Class C waste is waste that not only must meet more rigorous requirements on waste form to ensure stability but also requires additional measures at the disposal facility to protect against inadvertent intrusion. The physical form and characteristics of Class C waste must meet both the minimum and stability requirements set forth 12VAC5-481-2572.

4. Waste that is not generally acceptable for near-surface disposal is waste for which form and disposal methods must be different, and in general more stringent, than those specified for Class C waste. In the absence of specific requirements in this part, such waste must be disposed of in a geologic repository as defined in 10 CFR Part 60 or 63 unless proposals for disposal of such waste in a disposal site licensed pursuant to this part are approved by the agency.

C. Classification determined by long-lived radionuclides. If radioactive waste contains only radionuclides listed in Table 2, classification shall be determined as follows:

1. If the concentration does not exceed 0.1 times the value in Table 2, the waste is Class A.

2. If the concentration exceeds 0.1 times the value in Table 2 but does not exceed the value in Table 3, the waste is Class C.

3. If the concentration exceeds the value in Table 2, the waste is not generally acceptable for near-surface disposal.

4. For wastes containing mixtures of radionuclides listed in Table 2, the total concentration shall be determined by the sum of fractions rule described in subsection G of this section.

| Table 2 Long Lived Radionuclides Waste Concentration | | | --- | --- | | Radionuclide | Concentration curies per cubic meter | | C-14 | 8 | | C-14 in activated metal | 80 | | Ni-59 in activated metal | 220 | | Nb-94 in activated metal | 0.2 | | Tc-99 | 3 | | I-129 | 0.08 | | Alpha emitting transuranic nuclides with half-life greater than 5 years | ¹100 | | Pu-241 | ¹3,500 | | Cm-242 | ¹20,000 | | ¹Units are nanocuries per gram. | |

D. Classification determined by short-lived radionuclides. If radioactive waste does not contain any of the radionuclides listed in Table 2, classification shall be determined based on the concentrations shown in Table 3. However, as specified in subsection F of this section, if radioactive waste does not contain any nuclides listed in either Table 2 or 3, it is Class A.

1. If the concentration does not exceed the value in Column 1, the waste is Class A.

2. If the concentration exceeds the value in Column 1, but does not exceed the value in Column 2, the waste is Class B.

3. If the concentration exceeds the value in Column 2, but does not exceed the value in Column 3, the waste is Class C.

4. If the concentration exceeds the value in Column 3, the waste is not generally acceptable for near-surface disposal.

5. For wastes containing mixtures of the nuclides listed in Table 3, the total concentration shall be determined by the sum of fractions rule described in subsection G of this section.

| Table 3 Short Lived Radionuclide Waste Concentration | | | | | --- | --- | --- | --- | | Radionuclide | Concentration, curies per cubic meter | | | | Col. 1 | Col. 2 | Col. 3 | | | Total of all nuclides with less than 5 year half-life | 700 | ⁽¹⁾ | ⁽¹⁾ | | H-3 | 40 | ⁽¹⁾ | ⁽¹⁾ | | Co-60 | 700 | ⁽¹⁾ | ⁽¹⁾ | | Ni-63 | 3.5 | 70 | 700 | | Ni-63 in activated metal | 35 | 700 | 7000 | | Sr-90 | 0.04 | 150 | 7000 | | Cs-137 | 1 | 44 | 4600 | | ¹There are no limits established for these radionuclides in Class B or C wastes. Practical considerations such as the effects of external radiation and internal heat generation on transportation, handling, and disposal will limit the concentrations for these wastes. These wastes shall be Class B unless the concentrations of other nuclides in Table 3 determine the waste to the Class C independent of these nuclides. | | | |

E. Classification determined by both long- and short-lived radionuclides. If radioactive waste contains a mixture of radionuclides, some of which are listed in Table 2, and some of which are listed in Table 3, classification shall be determined as follows:

1. If the concentration of a nuclide listed in Table 2 does not exceed 0.1 times the value listed in Table 2, the class shall be that determined by the concentration of nuclides listed in Table 3.

2. If the concentration of a nuclide listed in Table 2 exceeds 0.1 times the value listed in Table 2 but does not exceed the value in Table 2, the waste shall be Class C, provided the concentration of nuclides listed in Table 3 does not exceed the value shown in Column 3 of Table 3.

F. Classification of wastes with radionuclides other than those listed in Tables 2 and 3. If radioactive waste does not contain any nuclides listed in either Table 2 or 3, it is Class A.

G. The sum of the fractions rule for mixtures of radionuclides. For determining classification for waste that contains a mixture of radionuclides, it is necessary to determine the sum of fractions by dividing each nuclide's concentration by the appropriate limit and adding the resulting values. The appropriate limits must all be taken from the same column of the same table. The sum of the fractions for the column must be less than 1.0 if the waste class is to be determined by that column. Example: A waste contains Sr-90 in a concentration of 50 Ci/m³ and Cs-137 in a concentration of 22 Ci/m³. Since the concentrations both exceed the values in Column 1, Table 2, they must be compared to Column 2 values. For Sr-90 fraction 50/150=0.33; for Cs-137 fraction, 22/44=0.5; the sum of the fractions=0.83. Since the sum is less than 1.0, the waste is Class B.

H. Determination of concentrations in wastes. The concentration of a radionuclide may be determined by indirect methods such as use of scaling factors that relate the inferred concentration of one radionuclide to another that is measured, or radionuclide material accountability, if there is reasonable assurance that the indirect methods can be correlated with actual measurements. The concentration of a radionuclide may be averaged over the volume of the waste, or weight of the waste if the units are expressed as nanocuries per gram.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2572 Waste characteristics

A. The following requirements are minimum requirements for all classes of waste and are intended to facilitate handling at the disposal site and provide protection of health and safety of personnel at the disposal site.

1. Waste must not be packaged for disposal in cardboard or fiberboard boxes.

2. Liquid waste must be solidified or packaged in sufficient absorbent material to absorb twice the volume of the liquid.

3. Solid waste containing liquid shall contain as little freestanding and noncorrosive liquid as is reasonably achievable, but in no case shall the liquid exceed 1.0% of the volume.

4. Waste must not be readily capable of detonation or of explosive decomposition or reaction at normal pressures and temperatures, or of explosive reaction with water.

5. Waste must not contain, or be capable of generating, quantities of toxic gases, vapors, or fumes harmful to persons transporting, handling, or disposing of the waste. This does not apply to radioactive gaseous waste packaged in accordance with subdivision 7 of this subsection.

6. Waste must not be pyrophoric. Pyrophoric materials contained in waste shall be treated, prepared, and packaged to be nonflammable.

7. Waste in a gaseous form must be packaged at a pressure that does not exceed 1.5 atmospheres at 20°C. Total activity must not exceed 100 curies per container.

8. Waste containing hazardous, biological, pathogenic, or infectious material must be treated to reduce to the maximum extent practicable the potential hazard from the nonradiological materials.

B. The requirements in this section are intended to provide stability of the waste. Stability is intended to ensure that the waste does not structurally degrade and affect overall stability of the site through slumping, collapse, or other failure of the disposal unit and thereby lead to water infiltration. Stability is also a factor in limiting exposure to an inadvertent intruder, since it provides a recognizable and nondispersible waste.

1. Waste must have structural stability. A structurally stable waste form will generally maintain its physical dimensions and its form, under the expected disposal conditions such as weight of overburden and compaction equipment, the presence of moisture, and microbial activity, and internal factors such as radiation effects and chemical changes. Structural stability can be provided by the waste form itself, processing the waste to a stable form, or placing the waste in a disposal container or structure that provides stability after disposal.

2. Notwithstanding the provisions in subdivision A 2 and A 3 of this section, liquid wastes, or wastes containing liquid, must be converted into a form that contains as little freestanding and noncorrosive liquid as is reasonably achievable, but in no case shall the liquid exceed 1.0% of the volume of the waste when the waste is in a disposal container designed to ensure stability, or 0.5% of the volume of the waste for waste processed to a stable form.

3. Void spaces within the waste and between the waste and its package must be reduced to the extent practicable.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2573 Labeling

Each package of waste must be clearly labeled to identify whether it is Class A waste, Class B waste, or Class C waste, in accordance with 12VAC5-481-2571.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2580 Institutional requirements

A. Land ownership. Disposal of waste received from other persons may be permitted only on land owned in fee by the federal or a state government.

B. Institutional control. The land owner or custodial agency shall conduct an institutional control program to physically control access to the disposal site following transfer of control of the disposal site from the disposal site operator. The institutional control program shall also include, but not be limited to, conducting an environmental monitoring program at the disposal site, periodic surveillance, minor custodial care, and other requirements as determined by the agency; and administration of funds to cover the costs for these activities. The period of institutional controls will be determined by the agency, but institutional controls may not be relied upon for more than 100 years following transfer of control of the disposal site to the owner.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2590 Alternative requirements for waste classification and characteristics

The agency licensing a low-level disposal facility may, upon request or on its own initiative, authorize other provisions for the classification and characteristics of waste on a specific basis, if, after evaluation of the specific characteristics of the waste, disposal site, method of disposal, it finds reasonable assurance of compliance with the performance objectives specified in this part.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

Article 5 Financial Assurances

12VAC5-481-2600 Applicant qualifications and assurances

Article 5 Financial Assurances

Each applicant shall show that it either possesses the necessary funds or has reasonable assurance of obtaining the necessary funds, or by a combination of the two, to cover the estimated costs of conducting all licensed activities over the planned operating life of the project, including costs of construction and disposal.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2610 Funding for disposal site closure and stabilization

A. The applicant shall provide assurances prior to the commencement of operations that sufficient funds will be available to carry out disposal site closure and stabilization, including: (i) decontamination or dismantlement of land disposal facility structures; and (ii) closure and stabilization of the disposal site so that following transfer of the disposal site to the site owner the need for ongoing active maintenance is eliminated to the extent practicable and only minor custodial care, surveillance, and monitoring are required. These assurances shall be based on agency-approved cost estimates reflecting the agency-approved plan for disposal site closure and stabilization. The applicant's cost estimates must take into account total costs that would be incurred if an independent contractor were hired to perform the closure and stabilization work.

B. In order to avoid unnecessary duplication and expense, the agency will accept financial sureties that have been consolidated with earmarked financial or surety arrangements established to meet requirements of federal or other state agencies (and/or local governmental bodies) for such decontamination, closure, and stabilization. The agency will accept these arrangements only if they are considered adequate to satisfy the requirements of this section and that the portion of the surety that covers the closure of the disposal site is clearly identified and committed for use in accomplishing these activities.

C. The licensee's financial or surety arrangement shall be submitted annually for review by the agency to assure that sufficient funds will be available for completion of the closure plan.

D. The amount of the licensee's financial or surety arrangement shall change in accordance with changes in the predicted costs of closure and stabilization. Factors affecting closure and stabilization cost estimates include inflation, increases in the amount of disturbed land, changes in engineering plans, closure and stabilization that has already been accomplished, and any other conditions affecting costs. The financial or surety arrangement shall be sufficient at all times to cover the costs of closure and stabilization of the disposal units that are expected to be used before the next license renewal.

E. The financial or surety arrangement shall be either open-ended or be written for a specified period of time and shall be automatically renewed unless the person who issues the surety notifies the agency, the beneficiary (the site owner), and the principal (the licensee) not less than 90 days prior to the renewal date of its intention not to renew. In such a situation, the licensee must submit a replacement surety within 30 days after notification of cancellation. If the licensee fails to provide a replacement surety acceptable to the agency, the beneficiary may collect on the original surety.

F. Proof of forfeiture shall not be necessary to collect the surety so that, in the event that the licensee could not provide an acceptable replacement surety within the required time, the surety shall be automatically collected prior to its expiration. The conditions described above shall be clearly stated on any surety instrument.

G. Financial or surety arrangements generally acceptable to the agency include surety bonds, cash deposits, certificates of deposit, deposits of government securities, escrow accounts, irrevocable letters or lines of credit, trust funds, and combinations of the above or such other types of arrangements as may be approved by the agency. Self-insurance, or any arrangement that essentially constitutes self-insurance, will not satisfy the surety requirement for private sector applicants.

H. The licensee's financial or surety arrangement shall remain in effect until the closure and stabilization program has been completed and approved by the agency, and the license has been transferred to the site owner.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2620 Financial assurances for institutional controls

A. Prior to the issuance of the license, the applicant shall provide for agency approval, a binding arrangement, between the applicant and the disposal site owner that ensures that sufficient funds will be available to cover the costs of monitoring and any required maintenance during the institutional control period. The binding arrangement shall be reviewed periodically by the agency to ensure that changes in inflation, technology, and disposal facility operations are reflected in the arrangements.

B. Subsequent changes to the binding arrangement specified in subsection A of this section relevant to institutional control shall be submitted to the agency for prior approval.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

Article 6 Records, Reports, Tests, and Inspections

12VAC5-481-2630 Maintenance of records, reports, and transfers

Article 6 Records, Reports, Tests, and Inspections

A. Each licensee shall maintain any records and make any reports in connection with the licensed activities as may be required by the conditions of the license or by the rules, regulations, and orders of the agency.

B. Records that are required by these regulations or by license conditions shall be maintained for a period specified by the appropriate regulations or by license condition. If a retention period is not otherwise specified, these records must be maintained and transferred to the officials specified in subsection D of this section as a condition of license termination unless the agency otherwise authorizes their disposition.

C. Records that shall be maintained pursuant to this part may be the original or a reproduced copy or microfilm if this reproduced copy or microfilm is capable of producing copy that is clear and legible at the end of the required retention period.

D. Notwithstanding subsections A through C of this section, copies of records of the location and the quantity of wastes contained in the disposal site must be transferred upon license termination to the chief executive of the nearest municipality, the chief executive of the county in which the facility is located, the county zoning board or land development and planning agency, the state governor, and other state, local and federal governmental agencies as designated by the agency at the time of license termination.

E. Following receipt and acceptance of a shipment of waste, the licensee shall record the date of disposal of the waste, the location in the disposal site, the condition of the waste packages as received, any discrepancies between materials listed on the manifest and those received, and any evidence of leaking or damaged packages or radiation or contamination levels in excess of limits specified in United States Department of Transportation and agency regulations. The licensee shall briefly describe any repackaging operations of any of the waste packages included in the shipment, plus any other information required by the agency as a license condition.

F. Each licensee authorized to dispose of waste received from other persons shall file a copy of its financial report or a certified financial statement annually with the agency in order to update the information base for determining financial qualifications.

G. Do the following:

1. Each licensee authorized to dispose of waste received from other persons, pursuant to this part, shall submit annual reports to the agency. Reports shall be submitted by the end of the first calendar quarter of each year for the preceding year.

2. The reports shall include:

a. Specification of the quantity of each of the principal contaminants released to unrestricted areas in liquid and in airborne effluents during the preceding year,

b. The results of the environmental monitoring program,

c. A summary of licensee disposal unit survey and maintenance activities,

d. A summary, by waste class, of activities and quantities of radionuclides disposed of,

e. Any instances in which observed site characteristics were significantly different from those described in the application for a license, and

f. Any other information the agency may require.

3. If the quantities of waste released during the reporting period, monitoring results, or maintenance performed are significantly different from those predicted, the report must cover this specifically.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2640 Tests on land disposal facilities

Each licensee shall perform, or permit the agency to perform, any tests the agency deems appropriate or necessary for the administration of the regulations in this part, including, but not limited to, tests of:

1. Wastes;

2. Facilities used for the receipt, storage, treatment, handling or disposal of wastes;

3. Radiation detection and monitoring instruments;

4. Other equipment and devices used in connection with the receipt, possession, handling, treatment, storage, or disposal of waste; or

5. Environmental sampling or testing.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2650 Agency inspections of land disposal facilities

A. Each licensee shall afford to the agency at all reasonable times opportunity to inspect waste not yet disposed of, and the premises, equipment, operations, and facilities in which wastes are received, possessed, handled, treated, stored, or disposed of.

B. Each licensee shall make available to the agency for inspection, upon reasonable notice, records kept by it pursuant to these regulations. Authorized representatives of the agency may copy and take away copies of, for the agency's use, any record required to be kept pursuant to these regulations.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

Article 1 Purpose and Scope

12VAC5-481-2660 Purpose and scope

Article 1 Purpose and Scope

A. This part contains requirements for the issuance of a license authorizing the use of sealed sources containing radioactive materials in irradiators used to irradiate objects or materials using gamma radiation. This part also contains radiation safety requirements for operating irradiators. The requirements of this part are in addition to other requirements of this chapter. In particular, the provisions of Parts III (12VAC5-481-380, et seq.), IV (12VAC5-481-600, et seq.), X (12VAC5-481-2250 et seq.), and XIII (12VAC5-481-2950, et seq.) of this chapter apply to applications and licenses subject to this part. Nothing in this part relieves licensees from complying with other applicable federal, state, and local regulations governing the siting, zoning, land use, and building code requirements for industrial facilities.

B. This part applies to panoramic irradiators that have either dry or wet storage of the radioactive sealed sources and to underwater irradiators in which both the source and the product being irradiated are underwater. Irradiators whose dose rates exceed 500 rad (5 gray) per hour at 1 meter from the radioactive sealed sources in air or in water, as applicable for the irradiator type, are covered by this part.

C. This part does not apply to self-contained dry-source-storage irradiators (those in which both the source and the area subject to irradiation are contained within a device and are not accessible by personnel), medical radiology or teletherapy, radiography (the irradiation of materials for nondestructive testing purposes), gauging, or open-field (agricultural) irradiators.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

Article 2 Specific Licensing Requirements

12VAC5-481-2670 Application for a specific license

Article 2 Specific Licensing Requirements

A person, as defined in 12VAC5-481-10, may file an application for a specific license authorizing the use of sealed sources in an irradiator. Each application shall be sent to the agency along with the appropriate fee prescribed in 12VAC5-490.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2680 Specific licenses for irradiators

A. The agency will approve an application for a specific license for the use of licensed material in an irradiator if the applicant meets the requirements contained in subsection B of this section and includes the information, as appropriate, from subsections C through I of this section.

B. The applicant shall satisfy the general requirements specified in 12VAC5-481-450 and the requirements contained in this part.

C. The application shall describe the training provided to the irradiator operators including:

1. Classroom training;

2. On-the-job training or simulator training;

3. Safety reviews;

4. Means employed by the applicant to test each operator's understanding of the agency regulations and licensing requirements and the irradiator operating and emergency procedures; and

5. Minimum training and experience of personnel who may provide training.

D. The application shall include the outline of the written operating and emergency procedures listed in the 12VAC5-481-2840 that describes the radiation safety aspects of the procedures.

E. The application shall describe the organizational structure for managing the irradiator, specifically the radiation safety responsibilities and authorities of the radiation safety officer and those management personnel who have important radiation safety responsibilities or authorities. In particular, the application shall specify who, within the management structure, has the authority to stop unsafe operations. The application shall also describe the training and experience required for the position of radiation safety officer.

F. The application shall include a description of the access control systems required by 12VAC5-481-2730, the radiation monitors required by 12VAC5-481-2760, the method of detecting leaking sources required by 12VAC5-481-2870 including the sensitivity of the method, and a diagram of the facility that shows the locations of all required interlocks and radiation monitors.

G. If the applicant intends to perform leak testing of dry-source-storage sealed sources, the applicant shall establish procedures for leak testing and submit a description of these procedures to the agency. The description shall include:

1. Instruments to be used;

2. Methods of performing the analysis; and

3. Pertinent experience of the individual who analyzes the samples.

H. If licensee personnel are to load or unload sources, the applicant shall describe the qualifications and training of the personnel and the procedures to be used. If the applicant intends to contract for source loading or unloading at its facility, the loading or unloading shall be done by an organization specifically licensed by the agency, NRC, or another agreement state to load or unload irradiator sources.

I. The applicant shall describe the inspection and maintenance checks, including the frequency of the checks required by 12VAC5-481-2880.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2690 Commencement of construction

Commencement of construction of a new irradiator may occur prior to the submission to the agency of both an application for a license for the irradiator and the fee required by 12VAC5-490. Any activities undertaken prior to the issuance of a license are entirely at the risk of the applicant and have no bearing on the issuance of a license. Commencement of construction, as defined in 12VAC5-481-10, may include non-construction activities if the activity has a reasonable nexus to radiological safety and security.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2700 Applications for exemptions

A. The agency may, upon application of any interested person or upon its own initiative, grant any exemptions from the requirements in this part that it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest.

B. Any application for a license or for amendment of a license authorizing use of a teletherapy-type unit for irradiation of materials or objects may include proposed alternatives for the requirements in this part. The agency will approve the proposed alternatives if the applicant provides adequate rationale for the proposed alternatives and demonstrates that it is likely to provide an adequate level of safety for workers and the public.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2710 Request for written statements

A. After the filing of an application, the agency may request further information necessary to enable the agency to determine whether the application shall be granted or denied.

B. Each license is issued with the condition that the licensee will, at any time before expiration of the license, upon the agency's request, submit written statements to enable the agency to determine whether the license shall be modified, suspended, or revoked.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

Article 3 Design and Performance Requirements for Irradiators

12VAC5-481-2720 Performance criteria for sealed sources

Article 3 Design and Performance Requirements for Irradiators

A. Sealed sources installed after July 1, 1993, shall:

1. Have a certificate of registration issued by the NRC or another agreement state;

2. Be doubly encapsulated;

3. Use radioactive material that is as nondispersible as practical and that is as insoluble as practical if the source is used in a wet-source-storage or wet-source-change irradiator;

4. Be encapsulated in a material resistant to general corrosion and to localized corrosion, such as 316L stainless steel or other material with equivalent resistance if the sources are for use in irradiator pools; and

5. In prototype testing of the sealed source, have been leak tested and found leak-free after each of the tests described in subsections B through G of this section.

B. The test source shall be held at -40ºC for 20 minutes, 600ºC for one hour, then be subjected to a thermal shock test with a temperature drop from 600ºC to 20ºC within 15 seconds.

C. The test source shall be twice subjected for at least five minutes to an external pressure (absolute) of 2 million newtons per square meter.

D. A 2-kilogram steel weight (2.5. centimeters in diameter) shall be dropped from a height of 1 meter onto the test source.

E. The test source shall be subjected three times for 10 minutes each to vibrations sweeping from 25 hertz to 500 hertz with a peak amplitude of five times the acceleration of gravity. In addition, each test source shall be vibrated for 30 minutes at each resonant frequency found.

F. A 50-gram weight and a pin (0.3 centimeter pin diameter) shall be dropped from a height of 1 meter onto the test source.

G. If the length of the source is more than 15 times larger than the minimum cross-sectional dimension, the test source shall be subjected to a force of 2000 newtons at its center equidistant from two support cylinders, the distance between which is 10 times the minimum cross-sectional dimension of the source.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2730 Access control

A. Each entrance to a radiation room at a panoramic irradiator shall have a door or other physical barrier to prevent inadvertent entry of personnel if the sources are not in the shielded position. Product conveyor systems may serve as barriers as long as they reliably and consistently function as a barrier. It shall not be possible to move the sources out of their shielded position if the door or barrier is open. Opening the door or barrier while the sources are exposed shall cause the sources to return promptly to their shielded position. The personnel entrance door or barrier shall have a lock that is operated by the same key used to move the sources. The doors and barriers shall not prevent any individual in the radiation room from leaving.

B. In addition, each entrance to a radiation room at a panoramic irradiator shall have an independent backup access control to detect personnel entry while the sources are exposed. Detection of entry while the sources are exposed shall cause the sources to return to their fully shielded position and shall also activate a visible and audible alarm to make the individual entering the room aware of the hazard. The alarm shall also alert at least one other individual who is onsite of the entry. That individual shall be trained on how to respond to the alarm and prepared to promptly render or summon assistance.

C. A radiation monitor shall be provided to detect the presence of high radiation levels in the radiation room of a panoramic irradiator before personnel entry. The monitor shall be integrated with personnel access door locks to prevent room access when radiation levels are high. Attempted personnel entry while the monitor measures high radiation levels, shall activate the alarm described in subsection B of this section. The monitor may be located in the entrance (normally referred to as the maze) but not in the direct radiation beam.

D. Before the sources move from their shielded position in a panoramic irradiator, the source control shall automatically activate conspicuous visible and audible alarms to alert personnel in the radiation room that the sources will be moved from their shielded position. The alarms shall give individuals enough time to leave the room before the sources leave the shielded position.

E. Each radiation room at a panoramic irradiator shall have a clearly visible and readily accessible control that would allow an individual in the room to make the sources return to their fully shielded position.

F. Each radiation room of a panoramic irradiator shall contain a control that prevents the sources from moving from the shielded position unless the control has been activated and the door or barrier to the radiation room has been closed within a preset time after activation of the control.

G. Each entrance to the radiation room of a panoramic irradiator and each entrance to the area within the personnel access barrier of an underwater irradiator shall be posted as required by 12VAC5-481-860. Radiation postings for panoramic irradiators shall comply with the posting requirements of 12VAC5-481-860, except that signs may be removed, covered, or otherwise made inoperative when the sources are fully shielded.

H. If the radiation room of a panoramic irradiator has roof plugs or other movable shielding, it shall not be possible to operate the irradiator unless the shielding is in its proper location. This requirement may be met by interlocks that prevent operation if shielding is not placed properly or by an operating procedure requiring inspection of shielding before operating.

I. Underwater irradiators shall have a personnel access barrier around the pool which shall be locked to prevent access when the irradiator is not attended. Only operators and facility management may have access to keys to the personnel access barrier. There shall be an intrusion alarm to detect unauthorized entry when the personnel access barrier is locked. Activation of the intrusion alarm shall alert an individual (not necessarily on site) who is prepared to respond or summon assistance.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2740 Shielding

A. The radiation dose rate in areas that are normally occupied during operation of a panoramic irradiator may not exceed 2 mrem (0.02 mSv) per hour at any location 30 centimeters or more from the wall of the room when the sources are exposed. The dose rate shall be averaged over an area not to exceed 100 square cm having no linear dimension greater than 20 centimeters. Areas where the radiation dose rate exceeds 2 mrem (0.02 mSv) per hour shall be locked, roped off, or posted.

B. The radiation dose at 30 centimeters over the edge of the pool of a pool irradiator may not exceed 2 mrem (0.02 mSv) per hour when the sources are in the fully shielded position.

C. The radiation dose rate at 1 meter from the shield of a dry-source-storage panoramic irradiator may not exceed 2 mrem (0.02 mSv) per hour and at 5 centimeters from the shield may not exceed 20 mrem (0.2 mSv) per hour.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2750 Fire protection

A. The radiation room at panoramic irradiator shall have heat and smoke detectors. The detectors shall activate an audible alarm. The alarm shall be capable of alerting a person who is prepared to summon assistance promptly. The sources shall automatically become fully shielded if a fire is detected.

B. The radiation room at a panoramic irradiator shall be equipped with a fire extinguishing system capable of extinguishing a fire without the entry of personnel into the room. The system for the radiation room shall have a shut-off valve to control flooding into unrestricted areas.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2760 Radiation monitors

A. Irradiators with automatic product conveyor systems shall have a radiation monitor with an audible alarm located to detect loose radioactive sources that are carried toward the product exit. If the monitor detects a source, an alarm shall sound and product conveyors shall stop automatically. The alarm shall be capable of alerting an individual in the facility who is prepared to summon assistance. Underwater irradiators in which the product moves within an enclosed stationary tube are exempt from this requirement.

B. Underwater irradiators that are not in a shielded radiation room shall have a radiation monitor over the pool to detect abnormal radiation levels. The monitor shall have an audible alarm and a visible indicator at entrances to the personnel access barrier around the pool. The alarm shall be capable of alerting an individual who is prepared to respond promptly.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2770 Control of source movement

A. The mechanism that moves the sources of a panoramic irradiator shall require a key to actuate. Actuation of the mechanism shall cause an audible signal to indicate that the sources are leaving the shielded position. Only one key may be in use at any time, and only operators or facility management may possess it. The key shall be attached to a portable radiation survey meter by a chain or cable. The lock for source control shall be designed so that the key may not be removed if the sources are in an unshielded position. The door to the radiation room shall require the same key.

B. The console of a panoramic irradiator shall have source position indicator that indicates when the sources are in the fully shielded position, when they are in transit, and when the sources are exposed.

C. The control console of a panoramic irradiator shall have a control that promptly returns the sources to the shielded position.

D. Each control for a panoramic irradiator shall be clearly marked as to its function.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2780 Irradiator pools

A. For licenses initially issued after July 1, 1993, irradiator pools shall have a method to safely store the sources during repairs of the pool and either:

1. Have a watertight stainless steel liner or a liner metallurgically compatible with other components in the pools; or

2. Be constructed so that there is a low likelihood of substantial leakage and have a surface designed to facilitate decontamination.

B. For licenses initially issued after July 1, 1993, irradiator pools shall have no outlets more than 0.5 meter below the normal low water level that could allow water to drain out of the pool. Pipes that have intakes more than 0.5 meter below the normal low water level and that could act as siphons shall have siphon breakers to prevent siphoning of pool water.

C. A means shall be provided to replenish water losses from the pool.

D. A visible indicator shall be provided in a clearly visible location to indicate if the pool water level is below the normal low water level or above the normal high water level.

E. Irradiator pools shall be equipped with a purification system designed to be capable of maintaining the water during normal operation at a conductivity of 20 microsiemens per centimeter or less and with a clarity so that the sources can be seen clearly.

F. A physical barrier, such as a railing or cover, shall be used around or over irradiator pools during normal operation to prevent personnel from accidentally falling into the pool. The barrier may be removed during maintenance, inspection, and service operations.

G. If long-handled tools or poles are used in irradiator pools, the radiation dose rate on the handling areas of the tools may not exceed 2 mrem (0.02 mSv) per hour.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2790 Source rack protection

If the product to be irradiated moves on a product conveyor system, the source rack and the mechanism that moves the rack shall be protected by a barrier or guides to prevent products and product carriers from hitting or touching the rack or mechanism.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2800 Power failures

A. If electrical power at a panoramic irradiator is lost for longer than 10 seconds, the sources shall automatically return to the shielded position.

B. The lock on the door of the radiation room of a panoramic irradiator may not be deactivated by a power failure.

C. During a power failure, the area of any irradiator where sources are located may be entered only when using an operable and calibrated radiation survey meter.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2810 Design requirements

A. For all irradiators, licensees shall evaluate the location and sensitivity of the monitor to detect sources carried by the product conveyor system as required by 12VAC5-481-2760 A. Licensees shall verify that the product conveyor is designed to stop before a source on the product conveyor would cause a radiation overexposure to any person.

B. For panoramic irradiators:

1. Licensees shall design shielding walls to meet generally accepted building code requirements for reinforced concrete and design the walls, wall penetrations, and entrance ways to meet the radiation shielding requirements of 12VAC5-481-2740. If the irradiator will use more than 5 million curies (2 x 10¹⁷ Bq) of activity, licensees shall evaluate the effects of heating of the shielding walls by the irradiator sources.

2. Licensees shall design the foundation, with consideration given to soil characteristics, to ensure it is adequate to support the weight of the facility shield walls.

3. Licensees shall verify from the design and logic diagram that the access control system will meet the requirements of 12VAC5-481-2730.

4. Licensees shall verify that the number, locations, and spacing of the smoke and heat detectors are appropriate to detect fires and that the detectors are protected from mechanical and radiation damage. Licensees shall verify that the design of the fire extinguishing system provides the necessary discharge patterns, densities, and flow characteristics for complete coverage of the radiation room and that the system is protected from mechanical and radiation damage.

5. Licensees shall verify that the source rack will automatically return to the fully shielded position if offsite power is lost for more than 10 seconds.

6. Licensees shall verify that electrical wiring and electrical equipment in the radiation room are selected to minimize failures due to prolonged exposure to radiation.

7. Licensees shall determine that source rack drops due to loss of power will not damage the source rack and that source rack drops due to failure of cables (or alternate means of support) will not cause loss of integrity of sealed sources.

8. Licensees shall review the design of the mechanism that moves the sources to assure that the likelihood of a struck source is low and that, if the rack sticks, a means exists to free it with minimal risk to personnel.

9. For panoramic irradiators to be built in seismic areas, licensees shall design the reinforced concrete radiation shields to retain their integrity in the event of an earthquake by designing to the seismic requirements of an appropriate source or local building codes, if current.

D. For pool irradiators:

1. Licensees shall design the pool to assure that it is leak resistant, that it is strong enough to bear the weight of the pool water and shipping casks, that a dropped cask would not fall on sealed sources, that all outlets or pipes meet the requirements of 12VAC5-481-2780 C, and that metal components are metallurgically compatible with other components in the pool.

2. Licensees shall verify that the design of the water purification system is adequate to meet the requirements of 12VAC5-481-2780 E. The system shall be designed so that water leaking from the system does not drain to unrestricted areas without being monitored.

3. Licensees shall verify that there are no crevices on the source or between the source and the source holders that would promote corrosion on a critical area of the source.

4. If licensees use radiation monitors to detect contamination under 12VAC5-481-2870 B, they shall verify that the design of radiation monitoring systems to detect pool contamination includes sensitive detectors located close to where contamination is likely to concentrate.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2820 Construction monitoring and acceptance testing

A. For all irradiators, licensees shall verify the proper operation of the monitor to detect sources carried on the product conveyor system and the related alarms and interlocks required by 12VAC5-481-2760 A.

B. For all irradiators with product conveyor systems, the licensee shall observe and test the operation of the conveyor system to assure that the requirements in 12VAC5-481-2790 are met for protection of the source rack and the mechanism that moves the rack; testing shall include tests of any limit switches and interlocks used to protect the source rack and mechanism that moves the rack from moving product carriers.

C. For panoramic irradiators:

1. Licensees shall monitor the construction of the shielding to verify that its construction meets design specifications and generally accepted building code requirements for reinforced concrete.

2. Licensees shall monitor the construction of the foundations to verify that their construction meets design specifications.

3. Licensees shall test the movement of the source racks for proper operation prior to source loading; testing shall include source rack lowering due to simulated loss of power.

4. Licensees shall test the completed access control system to assure that it functions as designed and that all alarms, controls, and interlocks work properly.

5. Licensees shall test the ability of the heat and smoke detectors to detect a fire, to activate alarms, and to cause the source rack to automatically become fully shielded. Licensees shall test the operability of the fire extinguishing system.

6. Licensees shall demonstrate that the source racks can be returned to their fully shielded positions without offsite power.

7. For panoramic irradiators that use a computer system to control the access control system, licensees shall verify that the access control system will operate properly if offsite power is lost and shall verify that the computer has security features that prevent an irradiator operator from commanding the computer to override the access control system when it is required to be operable.

8. Licensees shall verify that the electrical wiring and electrical equipment that were installed meet the design specifications.

D. For pool irradiators:

1. Licensees shall verify that the pool meets design specifications and shall test the integrity of the pool. Licensees shall verify that outlets and pipes meet the requirements of 12VAC5-481-2780 B.

2. Licensees shall verify that the water purification system, the conductivity meter, and the water level indicators operate properly.

3. Licensees shall verify the proper operation of the radiation monitors and the related alarm if used to meet 12VAC5-481-2870 B.

E. For underwater irradiators, licensees shall verify the proper operation of the over-the-pool monitor, alarms, and interlocks required by 12VAC5-481-2760 B.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

Article 4 Operation of Irradiators

12VAC5-481-2830 Training

Article 4 Operation of Irradiators

A. Before an individual is permitted to operate an irradiator without a supervisor present, the individual shall be instructed in:

1. The fundamentals of radiation protection applied to irradiators, including the differences between external radiation and radioactive contamination, units of radiation dose, agency dose limits, why large radiation doses shall be avoided, how shielding and access controls prevent large doses, how an irradiator is designed to prevent contamination, the proper use of survey meters and personnel dosimeters, other radiation safety features of an irradiator, and the basic function of the irradiator;

2. The requirements of Part X (12VAC5-481-2250 et seq.) and Part XII (12VAC5-481-2660 et seq.) of this chapter that are relevant to the irradiator;

3. The operation of the irradiator;

4. Those operating and emergency procedures listed in 12VAC5-481-2840 that the individual is responsible for performing; and

5. Case histories of accidents or problems involving irradiators.

B. Before an individual is permitted to operate an irradiator without a supervisor present, the individual shall pass a written test on the instruction received consisting primarily of questions based on the licensee's operating and emergency procedures that the individual is responsible for performing and other operations necessary to safely operate the irradiator without supervision.

C. Before an individual is permitted to operate an irradiator without a supervisor present, the individual shall have received on-the-job training or simulator training in the use of the irradiator as described in the license application. The individual shall also demonstrate the ability to perform those portions of the operating and emergency procedures that the individual is to perform.

D. Licensees shall conduct safety reviews for irradiator operators at least annually. Licensees shall give each operator a brief written test on the information. Each safety review shall include, to the extent appropriate, each of the following:

1. Changes in operating and emergency procedures since the last review;

2. Changes in regulations and license conditions since the last review;

3. Reports on recent accidents, mistakes, or problems that have occurred at irradiators;

4. Relevant results of inspections of operator safety performance;

5. Relevant results of the facility's inspection and maintenance checks; and

6. A drill to practice an emergency or abnormal event procedure.

E. Licensees shall evaluate the safety performance of each irradiator operator at least annually to ensure that regulations, license conditions, and operating and emergency procedures are followed. Licensees shall discuss the results of the evaluation with the operator and shall instruct the operator on how to correct mistakes or deficiencies observed.

F. Individuals who will be permitted unescorted access to the radiation room of the irradiator or the area around the pool of an underwater irradiator, but who have not received the training required for operators or for the radiation safety officer, shall be instructed and tested in precautions they shall take to avoid radiation exposure, procedures or parts of procedures listed in 12VAC5-481-2840 that they are expected to perform or comply with, and their proper response to alarms required in this part. Tests may be oral.

G. Individuals who shall be prepared to respond to alarms required by 12VAC5-481-2730 B and I, 12VAC5-481-2750 A, 12VAC5-481-2760, and 12VAC5-481-2870 B shall be trained and tested on how to respond. Each individual shall be retested at least once a year. Tests may be oral.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2840 Operating and emergency procedures

A. Licensees shall have and follow written operating procedures for:

1. Operation of the irradiator, including entering and leaving the radiation room;

2. Use of personnel dosimeters;

3. Surveying the shielding of panoramic irradiators;

4. Monitoring pool water for contamination while the water is in the pool and before release of pool water to unrestricted areas;

5. Leak testing of sources;

6. Inspection and maintenance checks required by 12VAC5-481-2880;

7. Loading, unloading, and repositioning sources if the operations will be performed by the licensee; and

8. Inspection of movable shielding required by 12VAC5-481-2730, if applicable.

B. Licensees shall have and follow written emergency or abnormal event procedures appropriate for the irradiator type for:

1. Sources stuck in the unshielded position;

2. Personnel overexposures;

3. A radiation alarm from the product exit portal monitor or pool monitor;

4. Detection of leaking sources, pool contamination, or alarm caused by contamination of pool water;

5. A low or high water level indicator, an abnormal water loss, or leakage from the source storage pool;

6. A prolonged loss of electrical power;

7. A fire alarm or explosion in the radiation room;

8. An alarm indicating unauthorized entry into the radiation room, area around pool, or another alarmed area;

9. Natural phenomena, including an earthquake, a tornado, flooding, or other phenomena as appropriate for the geographical location of the facility; and

10. The jamming of automatic conveyor systems.

C. Licensees may revise operating and emergency procedures without agency approval only if all of the following conditions are met:

1. The revisions do not reduce the safety of the facility;

2. The revisions are consistent with the outline or summary of procedures submitted with the license application;

3. The revisions have been reviewed and approved by the radiation safety officer; and

4. The users or operators are instructed and tested on the revised procedures before they are put into use.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2850 Personnel monitoring

A. Irradiator operators shall wear a personnel dosimeter while operating a panoramic irradiator or while in the area around the pool of an underwater irradiator. The personnel dosimeter must be capable of detecting high energy photons in the normal and accident dose ranges (see 12VAC5-481-750). Each personnel dosimeter shall be assigned to and worn by only one individual. Film badges shall be processed at least monthly, and other personnel dosimeters that require replacement shall be evaluated at least quarterly or promptly after replacement, whichever is more frequent.

B. Other individuals who enter the radiation room of a panoramic irradiator shall wear a dosimeter, which may be a pocket dosimeter. For groups of visitors, only two people who enter the radiation room are required to wear dosimeters. If pocket dosimeters are used to meet the requirements of this subsection, a check of their response to radiation shall be done at least annually. Acceptable dosimeters shall read within plus or minus 30% of the true radiation dose.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022; Errata, 38:4 VA.R. 478 October 11, 2021.

12VAC5-481-2860 Radiation surveys

A. A radiation survey of the area outside the shielding of the radiation room of a panoramic irradiator shall be conducted with the sources in the exposed position before the facility starts to operate. A radiation survey of the area above the pool of pool irradiators shall be conducted after the sources are loaded but before the facility starts to operate. Additional radiation surveys of the shielding shall be performed at intervals not to exceed three years and before resuming operation after addition of new sources or any modification to the radiation room shielding or structure that might increase dose rates.

B. If the radiation levels specified in 12VAC5-481-2740 are exceeded, the facility shall be modified to comply with the requirements in 12VAC5-481-2740.

C. Portable radiation survey meters shall be calibrated at least annually to an accuracy of plus or minus 20% for the gamma energy of the sources in use. The calibration shall be done at two points on each scale or for digital instruments at one point per decade over the range that will be used. Portable radiation survey meters shall be of a type that does not saturate and read zero at high radiation dose rates.

D. Water from the irradiator pool, other potentially contaminated liquids, and sediments from pool vacuuming shall be monitored for radioactive contamination before release to unrestricted areas. Radioactive concentrations shall not exceed those specified in Table 2, Column 2 or Table 3 of Appendix B to 10 CFR Part 20.

E. Before releasing resins for unrestricted use, they shall be monitored in an area with a background level less than 0.05 mrem (0.5 μSv) per hour. The resins may be released only if the survey does not detect radiation levels above background radiation levels. The survey meter used shall be capable of detecting radiation levels of 0.05 mrem (0.5 μSv) per hour.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2870 Detection of leaking sources

A. Each dry-source-storage sealed source shall be tested for leakage at intervals not to exceed six months using a leak test kit or method approved by the agency, NRC, or another agreement state. In the absence of a certificate from a transferor that a test has been made within the six months before the transfer, the sealed source may not be used until tested. The test shall be capable of detecting the presence of 0.005 μCi (200 Bq) of radioactive material and shall be performed by a person approved by the agency, the NRC, or another agreement state to perform the test.

B. For pool irradiators, sources may not be put into the pool unless the licensee tests the sources for leaks or has a certificate from a transferor that a leak test has been done within the six months before the transfer. Water from the pool shall be checked for contamination each day the irradiator operates. The check may be done either by using a radiation monitor on a pool water circulating system or by analysis of a sample of pool water. If a check for contamination is done by analysis of a sample of pool water, the results of the analysis shall be available within 24 hours. If the licensee uses a radiation monitor on a pool water circulating system, the detection of above normal radiation levels shall activate an alarm. The alarm set-point shall be set as low as practical, but high enough to avoid false alarms. The licensee may reset the alarm set-point to a higher level if necessary to operate the pool water purification system to clean up contamination in the pool if specifically provided for in written emergency procedures.

C. If a leaking source is detected, the licensee shall arrange to remove the leaking source from service and have it decontaminated, repaired, or disposed of by an agency, the NRC, or another agreement state licensee that is authorized to perform these functions. The licensee shall promptly check its personnel, equipment, facilities, and irradiated product for radioactive contamination. No product may be shipped until the product has been checked and found free of contamination. If a product has been shipped that may have been inadvertently contaminated, the licensee shall arrange to locate and survey that product for contamination. If any personnel are found to be contaminated, decontamination shall be performed promptly. If contaminated equipment, facilities, or products are found, the licensee shall arrange to have them decontaminated or disposed of by an agency, the NRC, or another agreement state licensee that is authorized to perform these functions. If a pool is contaminated, the licensee shall arrange to clean the pool until the contamination levels do not exceed the appropriate concentration in Table 2, Column 2 of Appendix B to 10 CFR Part 20. (See 12VAC5-481-1110 for reporting requirements.)

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 25, Issue 2, eff. November 1, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2880 Inspection and maintenance

A. Licensees shall perform inspection and maintenance checks that include, as a minimum, each of the following at the frequency specified in the license or license application:

1. Operability of each aspect of the access control system required by 12VAC5-481-2730;

2. Functioning of the source position indicator required by 12VAC5-481-2770 B;

3. Operability of the radiation monitor for radioactive contamination in pool water required by 12VAC5-481-2870 B using a radiation check source, if applicable;

4. Operability of the over-pool radiation monitor at underwater irradiators as required by 12VAC5-481-2760 B;

5. Operability of the product exit monitor required by 12VAC5-481-2760 A;

6. Operability of the emergency source return control required by 12VAC5-481-2770 C;

7. Leak-tightness of systems through which pool water circulates (visual inspection);

8. Operability of the heat and smoke detectors and extinguisher system required by 12VAC5-481-2750 (but without turning extinguishers on);

9. Operability of the means of pool water replenishment required by 12VAC5-481-2780 C;

10. Operability of the indicators of high and low pool water levels required by 12VAC5-481-2780 D;

11. Operability of the intrusion alarm required by 12VAC5-481-2730 I, if applicable;

12. Functioning and wear of the system, mechanisms, and cables used to raise and lower sources;

13. Condition of the barrier to prevent products from hitting the sources or source mechanism as required by 12VAC5-481-2790;

14. Amount of water added to the pool to determine if the pool is leaking;

15. Electrical wiring on required safety systems for radiation damage; and

16. Pool water conductivity measurements and analysis as required by 12VAC5-481-2890 B.

B. Malfunctions and defects found during inspection and maintenance checks shall be repaired without undue delay.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2890 Pool water purity

A. Pool water purification system shall be run sufficiently to maintain the conductivity of the pool water below 20 microsiemens per centimeter under normal circumstances. If pool water conductivity rises above 20 microsiemens per centimeter, licensees shall take prompt actions to lower pool water conductivity and shall take corrective actions to prevent future recurrences.

B. Licensees shall measure the pool water conductivity frequently enough, but no less than weekly, to assure that the conductivity remains below 20 microsiemens per centimeter. Conductivity meters shall be calibrated at least annually.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2900 Attendance during operation

A. Both an irradiator operator and at least one other individual who is trained on how to respond and prepared to promptly render or summon assistance if the access control alarm sounds shall be present on site:

1. Whenever the irradiator is operated using an automatic product conveyor system; and

2. Whenever the product is moved into or out of the radiation room when the irradiator is operated in a batch mode.

B. At a panoramic irradiator at which static irradiations (no movement of the product) are occurring, a person who has received the training on how to respond to alarms described in 12VAC5-481-2830 G shall be on site.

C. At an underwater irradiator, an irradiator operator shall be present at the facility whenever the product is moved into or out of the pool. Individuals who move the product into or out of the pool of an underwater irradiator need not be qualified as irradiator operators; however, they shall have received the training described in 12VAC5-481-2830 F and G. Static irradiations may be performed without a person present at the facility.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2910 Entering and leaving the radiation room

A. Upon first entering the radiation room of a panoramic irradiator after an irradiation, the irradiator operator shall use a survey meter to determine that the source has returned to the fully shielded position. The operator shall check the functioning of the survey meter with a radiation check source prior to entry.

B. Before exiting from and locking the door to the radiation room of a panoramic irradiator prior to a planned irradiation, the irradiator operator shall:

1. Visually inspect the entire radiation room to verify that no one else is in it; and

2. Activate a control in the radiation room that permits the sources to be moved from the shielded position only if the door to the radiation room is locked within a preset time after setting the control.

C. During a power failure, the area around the pool of an underwater irradiator may not be entered without using an operable and calibrated radiation survey meter unless the over-the-pool monitor required by 12VAC5-481-2760 B is operating with backup power.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2920 Irradiation of explosive or flammable materials

A. Irradiation of explosive material is prohibited unless the licensee has received prior written authorization from the agency. Authorization will not be granted unless the licensee can demonstrate that denotation of the explosive would not rupture the sealed sources, injure personnel, damage safety systems, or cause radiation overexposures to personnel.

B. Irradiation of more than small quantities of flammable material (flash point below 140ºF) is prohibited in panoramic irradiators unless the licensee has received prior written authorization from the agency. Authorization will not be granted unless the licensee can demonstrate that a fire in the radiation room could be controlled without damage to sealed sources or safety systems and without radiation overexposures to personnel.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

Article 5 Records

12VAC5-481-2930 Records and retention periods

Article 5 Records

Licensees shall maintain the following records at the irradiator for the periods specified:

1. A copy of the license, license conditions, documents incorporated into a license by reference, and amendments thereto until superseded by new documents or until the agency terminates the license for documents not superseded.

2. Records of each individual's training, tests, and safety reviews provided to meet the requirements of 12VAC5-481-2830 until three years after the individual terminates work.

3. Records of the annual evaluations of the safety performance of irradiator operators required by 12VAC5-481-2830 E for three years after the evaluations.

4. A copy of the current operating and emergency procedures required by 12VAC5-481-2840 until superseded or the agency terminates the license. Records of the radiation safety officer's review and approval of changes in procedures as required by 12VAC5-481-2840 C retained for three years from the date of the change.

5. Evaluations of personnel dosimeters required by 12VAC5-481-2850 until the agency terminates the license.

6. Records of radiation surveys required by 12VAC5-481-2860 for three years from the date of the survey.

7. Records of radiation survey meter calibrations required by 12VAC5-481-2860 and pool water conductivity meter calibrations required by 12VAC5-481-2890 B until three years from the date of calibration.

8. Records of the results of leak tests required by 12VAC5-481-2870 A and the results of contamination checks required by 12VAC5-481-2870 B for three years from the date of each test.

9. Records of inspection and maintenance checks required by 12VAC5-481-2880 for three years.

10. Records of major malfunctions, significant defects, operating difficulties or irregularities, and major operating problems that involve required radiation safety equipment for three years after repairs are completed.

11. Records of receipt, transfer, and disposal, of all licensed sealed sources as required by 12VAC5-481-571 and 12VAC5-481-3100.

12. Records on the design checks required by 12VAC5-481-2810 and the construction control checks as required by 12VAC5-481-2820 until the license is terminated. The records shall be signed and dated. The title or qualification of the person signing shall be included.

13. Records related to decommissioning of the irradiator as required by 12VAC5-481-450 C.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2940 Reports

A. In addition to the reporting requirements in this chapter, licensees shall report the following events:

1. Source stuck in an unshielded position;

2. Any fire or explosion in a radiation room;

3. Damage to the source racks;

4. Failure of the cable or drive mechanism used to move the source racks;

5. Inoperability of the access control system;

6. Detection of radiation source by the product exit monitor;

7. Detection of radioactive contamination attributable to licensed radioactive material;

8. Structural damage to the pool liner or walls;

9. Abnormal water loss or leakage from the source storage pool (greater than the design parameters); and

10. Pool water conductivity exceeding 100 microsiemens per centimeter.

B. The reports shall include a telephone report within 24 hours as described in 12VAC5-481-1100 and a written report within 30 days as described in 12VAC5-481-1110.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

Article 1 Purpose and Scope

12VAC5-481-2950 Purpose and scope

Article 1 Purpose and Scope

The regulations in this part apply to any licensee authorized by specific or general license issued by the agency to receive, possess, use, or transfer licensed material, if the licensee delivers that material to a carrier for transport, transports the material outside the site of usage as specified in the agency license, or transports that material on public highways. No provision of this part authorizes possession of licensed material.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 2 General Regulatory Provisions

12VAC5-481-2960 Requirement for license

Article 2 General Regulatory Provisions

No person shall transport radioactive material or deliver radioactive material to a carrier for transport except as authorized in a general or specific license issued by the agency or as exempted in 12VAC5-481-2970.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-2970 Exemptions

A. Common and contract carriers, freight forwarders, and warehouse workers that are subject to the requirements of the United States Department of Transportation (DOT) in 49 CFR Part 170 through 49 Part CFR 189 or the United States Postal Service in the Postal Service Domestic Mail Manual (DMM), Section C-023.9.0, and the United States Postal Service, are exempt from the requirements of this part to the extent that they transport or store radioactive material in the regular course of their carriage for others or storage incident thereto. Common and contract carriers that are not subject to the requirements of the DOT or United States Postal Service are subject to 12VAC5-481-2960 and other applicable requirements of these regulations.

B. A licensee is exempt from all the requirements of this part with respect to shipment or carriage of the following low-level materials:

1. Natural material and ores containing naturally occurring radionuclides that are either in their natural state, or have only been processed for purposes other than the extraction of the radionuclides, and that are not intended to be processed for use of these radionuclides, provided the activity concentration of the material does not exceed 10 times the values specified in Table 2 or Table 3 of 12VAC5-481-3770.

2. Materials for which the activity concentration is not greater than the activity concentration values specified in Table 2 or Table 3 of 12VAC5-481-3770, or for which the consignment activity is not greater than the limit for an exempt consignment found in Table 2 or Table 3 of 12VAC5-481-3770.

3. Nonradioactive solid objects with radioactive substances present on any surfaces in quantities not in excess of the levels cited in the definition of "contamination" in 12VAC5-481-10.

C. Fissile material meeting one of the following requirements are exempt from classification as fissile material and from the fissile material package standards of 10 CFR 71.55 and 10 CFR 71.59, but are subject to all other requirements of 10 CFR 71, except as noted.

1. Individual package containing two grams or less fissile material.

2. Individual or bulk packaging containing 15 grams or less of fissile material provided the package has at least 200 grams of solid nonfissile material for every gram of fissile material. Lead, beryllium, graphite, and hydrogenous material enriched in deuterium may be present in the package but must not be included in determining the required mass for solid nonfissile material.

3. Low concentrations of solid fissile material commingled with solid nonfissile material, provided that there is at least 2,000 grams of solid nonfissile material for every gram of fissile material, and there is no more than 180 grams of fissile material distributed within 360 kg of contiguous nonfissile material. Lead, beryllium, graphite, and hydrogenous material enriched in deuterium may be present in the package but must not be included in determining the required mass of solid nonfissile material.

4. Uranium enriched in uranium-235 to a maximum of 1.0% by weight, and with total plutonium and uranium-233 content of up to 1.0% of the mass of uranium-235, provided that the mass of any beryllium, graphite, and hydrogenous material enriched in deuterium constitutes less than 5.0% of the uranium mass, and that the fissile material is distributed homogeneously and does not form a lattice arrangement within the package.

5. Liquid solutions of uranyl nitrate enriched in uranium-235 to a maximum of 2.0% by mass, with a total plutonium and uranium-233 content not exceeding 0.002% of the mass of uranium, and with a minimum nitrogen to uranium atomic ratio (N/U) of 2. The material must be contained in at least a DOT Type A package.

6. Packages containing, individually, a total plutonium mass of not more than 1,000 grams, of which not more than 20% by mass may consist of plutonium-239, plutonium-241, or any combination of these radionuclides.

D. Any physician licensed by the Commonwealth of Virginia to dispense drugs in the practice of medicine is exempt from this section with respect to transport by the physician of radioactive material for use in the practice of medicine provided the physician is an authorized user under Part VII (12VAC5-481-1660 et seq.).

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 34, Issue 2, eff. October 18, 2017; Volume 34, Issue 14, eff. April 5, 2018.

12VAC5-481-2980 Transportation of licensed material

A. Each licensee who transports licensed material outside the site of usage, as specified in the agency license, or where transport is on public highways, or who delivers licensed material to a carrier for transport, shall:

1. Comply with the applicable requirements, appropriate to the mode of transport, of the regulations of the DOT; particularly the regulations of the DOT in the following areas:

a. Packaging – 49 CFR Part 173: Subparts A and B and I.

b. Marking and labeling – 49 CFR Part 172: Subpart D, 172.400 through 172.407 and 172.436 through 172.441.

c. Placarding – 49 CFR Part 172: Subpart F, especially §§ 172.500 through 172.519, 172.556, and Appendices B and C.

d. Accident reporting – 49 CFR Part 171: §§ 171.15 and 171.16.

e. Shipping papers and emergency information – 49 CFR Part 172: Subpart C and Subpart G.

f. Hazardous material employee training – 49 CFR Part 172: Subpart H.

g. Hazardous material shipper/carrier registration – 49 CFR Part 107: Subpart G.

h. Security plans – 49 CFR Part 172: Subpart I.

2. The licensee shall also comply with applicable DOT regulations pertaining to the following modes of transportation:

a. Rail – 49 CFR Part 174: Subparts A through D and K.

b. Air – 49 CFR Part 175.

c. Vessel – 49 CFR Part 176: Subparts A through F and M.

d. Public Highway – 49 CFR Part 177 and Parts 390 through 397.

3. Assure that any special instructions needed to safely open the package are sent to or have been made available to the consignee in accordance with 12VAC5-481-900.

B. If, for any reason, the regulations of the DOT are not applicable to a shipment of licensed material, the licensee shall conform to the standards and requirements of 49 CFR Parts 107, 171 through 180, and 390 through 397, appropriate to the mode of transport to the same extent as if the shipment was subject to the regulations.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 3 General Licenses

12VAC5-481-2990 General licenses for carriers

Article 3 General Licenses

A. A general license is hereby issued to any common or contract carrier not exempt under 12VAC5-481-2970 to receive, possess, transport, and store radioactive material in the regular course of their carriage for others or storage incident thereto, provided the transportation and storage is in accordance with the applicable requirements, appropriate to the mode of transport, of the United States Department of Transportation insofar as such requirements relate to the loading and storage of packages, placarding of the transporting vehicle, and incident reporting. Notification of an incident shall be filed with, or made to, the agency as prescribed in 49 CFR, regardless of or in addition to notification made to the United States Department of Transportation or other agencies.

B. A general license is hereby issued to any private carrier to transport radioactive material, provided the transportation is in accordance with the applicable requirements, appropriate to the mode of transport, of the United States Department of Transportation insofar as such requirements relate to the loading and storage of packages, placarding of the transporting vehicle, and incident reporting. Notification of an incident shall be filed with, or made to, the agency as prescribed in 49 CFR, regardless of or in addition to notification made to the United States Department of Transportation or other agencies.

C. Persons who transport radioactive material pursuant to the general licenses in subsection A or B of this section are exempt from the requirements of Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter to the extent that they transport radioactive material.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-3000 General license: NRC-approved packages

A. A general license is hereby issued to any licensee to transport, or to deliver to a carrier for transport, licensed material in a package for which a license, certificate of compliance (CoC), or other approval has been issued by the NRC. This general license applies only to a licensee who has a quality assurance program approved by the agency as satisfying the provisions of 12VAC5-481-3130.

B. This general license applies only to a licensee who:

1. Has a copy of the license, CoC, or other approval by the NRC of the package and has the drawings and other documents referenced in the approval relating to the use and maintenance of the packaging and to the actions to be taken prior to shipment;

2. Complies with the terms and conditions of the license, certificate, or other approval by the NRC, as applicable, and the applicable requirements of Part XIII (12VAC5-481-2950 et seq.) of this chapter;

3. Prior to the licensee's first use of the package, submits in writing to the NRC: ATTN: Document Control Desk, Director, Division of Fuel Management, Office of Nuclear Material Safety and Safeguards, using an appropriate method listed in 10 CFR 71.1(a), the licensee's name and license number and the package identification number specified in the package approval; and

4. Has a quality assurance program that complies with 12VAC5-481-3130.

C. The general license in subsection A of this section applies only when the package approval authorizes use of the package under this general license.

D. For a Type B or fissile material package, the design of which was approved by the NRC before April 1, 1996, the general license is subject to the additional restrictions of 12VAC5-481-3010.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 34, Issue 2, eff. October 18, 2017; Volume 34, Issue 14, eff. April 5, 2018; Volume 37, Issue 25, eff. January 14, 2022.

12VAC5-481-3010 Previously approved packages

A Type B(U) package, a Type B(M) package or a fissile material package, previously approved by the NRC but without the designation "-85" in the identification number of the NRC CoC, may be used under the general license of 12VAC5-481-3000 with the following additional conditions:

1. Fabrication of the package is satisfactorily completed by April 1, 1999, as demonstrated by application of its model number in accordance with 10 CFR 71.85(c);

2. A package used for a shipment to a location outside the United States is subject to multilateral approval except approved under special arrangement in accordance with United States Department of Transportation regulations at 49 CFR 173.403; and

3. A serial number that uniquely identifies each packaging that conforms to the approved design is assigned to and legibly and durably marked on the outside of each packaging.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3020 General License: United States Department of Transportation specification container

A. A general license is issued to any licensee to transport, or to deliver to a carrier for transport, licensed material in a specification container for fissile material or for a Type B quantity of radioactive material as specified in 49 CFR Parts 173 and 178.

B. This general license applies only to a licensee who:

1. Has a copy of the specification;

2. Complies with the terms and conditions of the specification and the applicable requirements of this part; and

3. Has a quality assurance program that complies with 12VAC5-481-3130.

C. The general license in subsection A of this section is subject to the limitation that the specification container may not be used for a shipment to a location outside the United States except by multilateral approval as defined in 49 CFR 173.403.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3030 General license: use of foreign approved package

A. A general license is issued to any licensee to transport, or to deliver to a carrier for transport, licensed material in a package the design of which has been approved in a foreign national competent authority certificate that has been revalidated by the DOT as meeting the applicable requirements of 49 CFR 171.23.

B. This general license applies only to shipments made to or from locations outside the United States.

C. This general license applies only to a licensee who:

1. Has a copy of the applicable certificate, the revalidation, and the drawings and other documents referenced in the certificate relating to the use and maintenance of the packaging and to the actions to be taken prior to shipment;

2. Complies with the terms and conditions of the certificate and revalidation, and with the applicable requirements of this part; and

3. The licensee has a quality assurance program approved by the agency that complies with 12VAC5-481-3130.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 34, Issue 2, eff. October 18, 2017.

12VAC5-481-3040 General license: fissile material

A. A general license is issued to any licensee to transport fissile material, or to deliver fissile material to a carrier for transport, if the material is shipped in accordance with this section. The fissile material need not be contained in a package that meets the standards of 10 CFR Part 71, Subparts E and F; however, the material must be contained in a Type A package. The Type A package must also meet the DOT requirements of 49 CFR 173.417(a).

B. The general license applies only to a licensee who has a quality assurance program that complies with 12VAC5-481-3130.

C. The general license applies only when a package's contents:

1. Contain no more than a Type A quantity of radioactive material; and

2. Contain less than 500 total grams of beryllium, graphite, or hydrogenous material enriched in deuterium.

D. The general license applies only to packages containing fissile material that are labeled with a CSI that:

1. Has been determined in accordance with subsection E of this section;

2. Has a value less than or equal to 10; and

3. For a shipment of multiple packages containing fissile material, the sum of the CSIs must be less than or equal to 50 (for shipment on a nonexclusive use conveyance) and less than or equal to 100 (for shipment on an exclusive use conveyance).

E. The value for the CSI must be greater than or equal to the number calculated by the following equation:

1. The calculated CSI must be rounded up to the first decimal place;

2. The values of X, Y, and Z used in the CSI equation must be taken from Tables 5 or 6, as appropriate;

3. If Table 5 is used to obtain the value of X, then the values for the terms in the equation for uranium-233 and plutonium must be assumed to be zero; and

4. Table 4 values for X, Y, and Z must be used to determine the CSI if:

a. Uranium-233 is present in the package;

b. The mass of plutonium exceeds one percent of the mass of uranium-235;

c. The uranium is of unknown uranium-235 enrichment or greater than 24 weight percent enrichment; or

d. Substances having a moderating effectiveness (i.e., an average hydrogen density greater than H₂O) (e.g., certain hydrocarbon oils or plastics) are present in any form, except as polyethylene used for packing or wrapping.

| Table 4 Mass Limits for General License Packages Containing Mixed Quantities of Fissile Material or Uranium-235 of Unknown Enrichment | | | | --- | --- | --- | | Fissile material | Fissile material mass mixed with moderating substances having an average hydrogen density less than or equal to H₂O (grams) | Fissile material mass mixed with moderating substances having an average hydrogen density greater than H₂O^a (grams) | | U-235 (X) | 60 | 38 | | U-233 (Y) | 43 | 27 | | Pu-239 or Pu-241 (Z) | 37 | 24 | | ^aWhen mixtures of moderating substances are present, the lower mass limits shall be used if more than 15 percent of the moderating substance has an average hydrogen density greater than H₂O. | | |

| Table 5 Mass Limits for General License Packages Containing Uranium-235 of Known Enrichment | | | --- | --- | | Uranium enrichment in weight percent of U-235 not exceeding | Fissile material mass of U-235 (X) (grams) | | 24 | 60 | | 20 | 63 | | 15 | 67 | | 11 | 72 | | 10 | 76 | | 9.5 | 78 | | 9 | 81 | | 8.5 | 82 | | 8 | 85 | | 7.5 | 88 | | 7 | 90 | | 6.5 | 93 | | 6 | 97 | | 5.5 | 102 | | 5 | 108 | | 4.5 | 114 | | 4 | 120 | | 3.5 | 132 | | 3 | 150 | | 2.5 | 180 | | 2 | 246 | | 1.5 | 408 | | 1.35 | 480 | | 1 | 1,020 | | 0.92 | 1,800 |

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3050 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; repealed, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3051 General license: plutonium-berylium special form material

A. A general license is issued to any licensee to transport fissile material in the form of plutonium-beryllium (Pu-Be) special form sealed sources, or to deliver Pu-Be sealed sources to a carrier for transport, if the material is shipped in accordance with this section. This material need not be contained in a package that meets the standards of Subparts E and F of 10 CFR Part 71; however, the material must be contained in a Type A package. The Type A package must also meet the DOT requirements of 49 CFR 173.417(a).

B. The general license applies only to a licensee who has a quality assurance program that complies with 12VAC5-481-3130.

C. The general license applies only when a package's contents:

1. Contain no more than a Type A quantity of radioactive material; and

2. Contain less than 1,000 grams of plutonium, provided that: plutonium-239, plutonium-241, or any combination of these radionuclides, constitutes less than 240 grams of the total quantity of plutonium in the package.

D. The general license applies only to packages labeled with a CSI that:

1. Has been determined in accordance with subsection E of this section;

2. Has a value less than or equal to 100; and

3. For a shipment of multiple packages containing Pu-Be sealed sources, the sum of the CSIs must be less than or equal to 50 (for shipment on a nonexclusive use conveyance) and less than or equal to 100 (for shipment on an exclusive use conveyance).

E. The value for the CSI must be greater than or equal to the number calculated by the following equation:

The calculated CSI must be rounded up to the first decimal place.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 4 Operating Controls and Procedures

12VAC5-481-3060 Assumptions as to unknown properties of fissile material

Article 4 Operating Controls and Procedures

When the isotopic abundance, mass, concentration, degree of irradiation, degree of moderation, or other pertinent property of fissile material in any package is not known, the licensee shall package the fissile material as if the unknown properties have credible values that will cause the maximum neutron multiplication.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-3070 Preliminary determinations

Prior to the first use of any packaging for the shipment of radioactive material, the licensee shall ascertain that the determinations made in 10 CFR 71.85(a) through (c) have been made.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 34, Issue 2, eff. October 18, 2017.

12VAC5-481-3080 Routine determinations

Prior to each shipment of licensed material, the licensee shall determine that:

1. The package is proper for the contents to be shipped;

2. The package is in unimpaired physical condition except for superficial defects such as marks or dents;

3. Each closure device of the packaging, including any required gasket, is properly installed and secured and free of defects;

4. Any system for containing liquid is adequately sealed and has adequate space or other specified provision for expansion of the liquid;

5. Any pressure relief device is operable and set in accordance with written procedures;

6. The package has been loaded and closed in accordance with written procedures;

7. For fissile material, any moderator or neutron absorber, if required, is present and in proper condition;

8. Any structural part of the package that could be used to lift or tie down the package during transport is rendered inoperable for that purpose unless it satisfies design requirements specified in 10 CFR 71.45;

9. The level of nonfixed radioactive contamination on the external surfaces of each package offered for shipment is ALARA and within the limits specified in 49 CFR 173.443;

10. External radiation levels around the package and around the vehicle, if applicable, will not exceed the limits specified in 10 CFR 71.47 at any time during transportation; and

11. Accessible package surface temperatures will not exceed the limits specified in 10 CFR 71.43(g) at any time during transportation.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3090 Air transport of plutonium

Notwithstanding the provisions of any general licenses and notwithstanding any exemptions stated directly in this part or included indirectly by citation of the DOT regulations, as may be applicable, the licensee shall assure that plutonium in any form is not transported by air, or delivered to a carrier for air transport, unless:

1. The plutonium is contained in a medical device designed for individual human application;

2. The plutonium is contained in a material in which the specific activity is less than or equal to the activity concentration values for plutonium specified in Table A-2 of 12VAC5-481-3770 and in which the radioactivity is essentially uniformly distributed;

3. The plutonium is shipped in a single package containing no more than an A₂ quantity of plutonium in any isotope or form and is shipped in accordance with 12VAC5-481-2980;

4. The plutonium is shipped in a package specifically authorized, in the CoC, issued by the NRC, for the shipment of plutonium by air and the licensee requires, through special arrangement with the carrier, compliance with 49 CFR 175.704, the DOT regulations applicable to the air transport of plutonium.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3091 Opening instructions.

Before delivery of a package to a carrier for transport, the licensee shall ensure that any special instructions needed to safely open the package have been sent to, or otherwise made available to, the consignee for the consignee's use in accordance with 12VAC5-481-900.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3100 Shipment records

A. Each licensee shall maintain for a period of three years after shipment a record of each shipment of licensed material not exempt under 12VAC5-481-2970, showing, where applicable:

1. Identification of the packaging by model number and serial number;

2. Verification that the packaging, as shipped, had no significant defect;

3. Volume and identification of coolant;

4. Type and quantity of licensed material in each package, and the total quantity of each shipment;

5. Date of the shipment;

6. Name and address of the transferee;

7. Address to which the shipment was made; and

8. Results of the determinations required by 12VAC5-481-3080 and by the conditions of the package approval.

9. For each item of irradiated fissile material, in addition to the items listed in subdivisions 1 through 8 of this subsection, identification by model number and serial number; irradiation and decay history to the extent appropriate to demonstrate that its nuclear and thermal characteristics comply with license conditions; and any abnormal or unusual condition relevant to radiation safety.

10. For each fissile package and for Type B packages, in addition to the items listed in subdivisions 1 through 8 of this subsection, any special controls exercised.

B. Each licensee shall maintain, for a period of three years after the life of the packaging to which they apply, records identifying the packaging by model number, serial number, and date of manufacture.

C. The licensee shall make available to the agency for inspection, upon reasonable notice, all records required by this section. Records are valid if stamped, initialed, or signed and dated by authorized personnel, or otherwise authenticated.

D. The licensee shall maintain sufficient written records to furnish evidence of the quality of the packaging. The records to be maintained include results of the determinations made by 12VAC5-481-3000; design, fabrication, and assembly records; results of reviews, inspections, tests, and audits; results of monitoring work performance and materials analyses; and results of maintenance, modification, and repair activities. Inspection, test, and audit records must identify the inspector or data recorder, the type of observation, the results, the acceptability, and the actions to be taken in connection with any deficiencies noted. These records must be retained for three years after the life of the packaging to which they apply.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 34, Issue 2, eff. October 18, 2017.

12VAC5-481-3110 Reports

The licensee shall report to the agency within 30 days:

1. Any instance in which there is significant reduction in the effectiveness of any packaging during use;

2. Details of any defects with safety significance in the packaging after first use, with the means employed to repair the defects and prevent their recurrence; or

3. Instances in which the conditions of approval in the CoC were not observed in making a shipment.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3120 Advance notification of transport of nuclear waste

A. Prior to the transport of any nuclear waste outside of the confines of the licensee's facility or other place of use or storage, or prior to the delivery of any nuclear waste to a carrier for transport, each licensee shall provide advance notification of such transport.

B. Advance notification for transport of licensed material is required when:

1. The licensed material is required to be in Type B packaging for transportation;

2. The licensed material is being transported to or across state boundary en route to a disposal facility or to a collection point for transport to a disposal facility; and

3. The quantity of licensed material in a single package exceeds:

a. 3000 times the A₁value of the radionuclides as specified in 12VAC5-481-3770;

b. 3000 times the A₂value of the radionuclides as specified in 12VAC5-481-3770; or

c. 1000 terabecquerel (27,000 curies).

C. Each advance notification required by subsections A and B of this section shall contain the following information:

1. The name, address, and telephone number of the shipper, carrier, and receiver of the shipment;

2. A description of the nuclear waste contained in the shipment as required by 49 CFR 172.202 and 172.203(d);

3. The point of origin of the shipment and the seven-day period during which departure of the shipment is estimated to occur;

4. The seven-day period during which arrival of the shipment at state boundaries or tribal reservation boundaries is estimated to occur;

5. The destination of the shipment, and the seven-day period during which arrival of the shipment is estimated to occur; and

6. A point of contact with a telephone number for current shipment information.

D. The notification required by subsections A and B of this section shall be made in writing to each office of the governor or governor's designee, the office of each appropriate tribal official or tribal official's designee, and to the agency. A notification delivered by mail shall be postmarked at least seven days before the beginning of the seven-day period during which departure of the shipment is estimated to occur. A notification delivered by any other means than mail shall reach each office of the governor or governor's designee, the office of each appropriate tribal official or tribal official's designee, and the agency, at least four days before the beginning of the seven-day period during which departure of the shipment is estimated to occur. A copy of the notification shall be retained by the licensee for three years.

1. Reserved.

2. Contact information for each state, including telephone and mailing addresses of governors and governors' designees, and participating tribes, including telephone and mailing addresses of tribal officials and tribal officials' designees, is available on the NRC website at: https://scp.nrc.gov/special/designee.pdf.

3. A list of the names and mailing addresses of the governors' designees and tribal officials' designees of participating tribes is available on request from the Director, Division of Materials Safety, Security, State, and Tribal Programs, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

E. The licensee shall notify the governor or governor's designee, the office of each appropriate tribal official or tribal official's designee, and the agency of any changes to schedule information provided pursuant to subsections A and B of this section. Such notification shall be by telephone to a responsible individual in the office of the governor or governor's designee, the office of each appropriate tribal official or tribal official's designee, and the agency. The licensee shall maintain for three years a record of the name of the individual contacted.

F. Each licensee who cancels a nuclear waste shipment, for which advance notification has been sent, shall send a cancellation notice, identifying the advance notification that is being canceled, to the governor or governor's designee, the office of each appropriate tribal official or tribal official's designee, and to the agency. A copy of the notice shall be retained by the licensee for three years.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 33, Issue 11, eff. February 22, 2017; Volume 37, Issue 25, eff. January 14, 2022; Volume 39, Issue 24, eff. August 16, 2023.

Article 5 Quality Assurance

12VAC5-481-3130 Quality assurance

Article 5 Quality Assurance

A. Quality assurance requirements apply to the design, purchase, fabrication, handling, shipping, storing, cleaning, assembly, inspection, testing, operation, maintenance, repair, and modification of components of packaging that are important to safety. Quality assurance comprises all those planned and systematic actions necessary to provide adequate confidence that a system or component will perform satisfactorily in service. Quality assurance includes quality control, which comprises those quality assurance actions related to control of the physical characteristics and quality of the material or component to predetermined requirements. Each licensee is responsible for the quality assurance provision that applies to its use of packaging for the shipment of licensed material subject to this chapter.

B. Each licensee shall establish, maintain, and execute a quality assurance program satisfying each of that applicable criteria of this section, 10 CFR Part 71 Subpart H and satisfying any specific provisions that are applicable to the licensee's activities including procurement of packaging. The licensee shall execute the applicable criteria in a graded approach to an extent that is commensurate with the quality assurance requirement's importance to safety.

C. Before the use of any package for the shipment of licensed material subject to this rule, each licensee shall obtain approval of its quality assurance program. Using an appropriate method, each licensee shall file a description of its quality assurance program, including a discussion of which requirements of this section are applicable and how they will be satisfied by submitting the description to the agency.

D. A program for transport container inspection and maintenance limited to radiographic exposure devices, source changers, or packages transporting these devices and meeting the requirements of 12VAC5-481-1270 or equivalent NRC or agreement state requirement, is deemed to satisfy the requirements of 12VAC5-481-3000 and subsection B of this section.

E. The licensee shall be responsible for the establishment and execution of the quality assurance program. The licensee may delegate to others, such as contractors, agents, or consultants, the work of establishing and executing the quality assurance program, or any part of the quality assurance program, but shall retain responsibility for the program. The licensee shall clearly establish and delineate, in writing, the authority and duties of persons and organizations performing activities affecting the safety-related functions of structures, systems, and components. These activities include performing the functions associated with attaining quality objectives and the quality assurance functions. While the term licensee is used in these criteria, the requirements are applicable to whatever design, fabrication, assembly, and testing of the package is accomplished with respect to a package before the time a package is issued.

F. The quality assurance functions are:

1. Assuring that an appropriate quality assurance program is established and effectively executed; and

2. Verifying, by procedures such as checking, auditing, and inspection, that activities affecting the safety-related functions have been performed correctly.

G. The persons and organizations performing quality assurance functions must have sufficient authority and organizational freedom to:

1. Identify quality problems;

2. Initiate, recommend, or provide solutions; and

3. Verify implementation of solutions.

H. Changes to the quality assurance program.

1. Each quality assurance program approval holder shall submit a description of a proposed change to its agency approved quality assurance program that will reduce commitments in the program description as approved by the agency. The quality assurance program approval holder shall not implement the change before receiving approval.

The description of a proposed change to the agency approved quality assurance program must identify the change, the reason for the change, and the basis for concluding that the revised program incorporating the change continues to satisfy the applicable requirements of this section.

2. Each quality assurance program approval holder may change a previously approved quality assurance program without prior agency approval if the change does not reduce the commitments in the quality assurance program previously approved by the agency. Changes to the quality assurance program that do not reduce the commitments shall be submitted to the agency every 24 months. In addition to quality assurance program changes involving administrative improvements and clarifications, spelling corrections, and nonsubstantive changes to punctuation or editorial items, the following changes are not considered reductions in commitment:

a. The use of a quality assurance standard approved by the agency that is more recent than the quality assurance standard in the licensee's current quality assurance program at the time of the change;

b. The use of generic organizational position titles that clearly denote the position function, supplemented as necessary by descriptive text, rather than specific titles, provided that there is no substantive change to either the functions of the position or reporting requirements;

c. The use of generic organization charts to indicate functional relationships, authorities, and responsibilities, or alternatively, the use of descriptive text, provided that there is no substantive change to the functional relationships, authorities, or responsibilities;

d. The elimination of quality assurance program information that duplicates language in quality assurance regulatory guides and quality assurance standards to which the quality assurance program approval holder has committed to on record; and

e. Organizational revisions that ensure that persons and organizations performing quality assurance functions continue to have the requisite authority and organizational freedom, including independence from cost and schedule when opposed to safety considerations.

3. Each quality assurance program approval holder shall maintain records of quality assurance program changes.

I. The licensee shall maintain sufficient written records to describe the activities affecting quality. These records must include the changes to the quality assurance program as required by subsection H of this section, the instructions, procedures, and drawings required by this section to prescribe quality assurance activities, and closely related specifications such as required qualifications of personnel, procedures, and equipment. The records must include the instructions or procedures that establish a records retention program that is consistent with applicable regulations and designates factors such as duration, location, and assigned responsibility. The licensee shall retain these records for three years beyond the date when the licensee last engaged in the activity for which the quality assurance program was developed. If any portion of the quality assurance program, written procedures or instructions is superseded, the licensee shall retain the superseded material for three years after it is superseded.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 34, Issue 2, eff. October 18, 2017; Volume 34, Issue 14, eff. April 5, 2018.

Article 1 Purpose and Scope

12VAC5-481-3140 Purpose

Article 1 Purpose and Scope

The regulations in this part establish radiation safety requirements for using sources of radiation for wireline service operations including mineral-logging, radioactive markers, and subsurface tracer studies. The requirements of this part are in addition to, and not in substitution for, the requirements of Parts I (12VAC5-481-10 et seq.), II (12VAC5-481-260 et seq.), III (12VAC5-481-380 et seq.), IV (12VAC5-481-600 et seq.), and X (12VAC5-481-2250 et seq.) of this chapter.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3150 Scope

The regulations in this part apply to all licensees or registrants who use sources of radiation for wireline service operations including mineral-logging, radioactive markers, or subsurface tracer studies.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-3151 Licensing

A. The agency will approve an application for a specific license for the use of licensed material in well logging if the applicant meets the following requirements:

1. The applicant satisfies the general requirements specified in 12VAC5-481-440 and 12VAC5-481-450.

2. The applicant shall develop a program for training logging supervisors and logging assistants and submit to the agency a description of this program that specifies:

a. Initial training;

b. On-the-job training;

c. Annual safety reviews provided by the licensee;

d. Means the applicant will use to demonstrate the logging supervisor's knowledge and understanding of and ability to comply with the agency's regulations and licensing requirements and the applicant's operating and emergency procedures; and

e. Means the applicant will use to demonstrate the logging assistant's knowledge and understanding of and ability to comply with the applicant's operating and emergency procedures.

3. The applicant shall submit to the agency written operating and emergency procedures as described in 12VAC5-481-3280 or an outline or summary of the procedures that includes the important radiation safety aspects of the procedures.

4. The applicant shall establish and submit to the agency its program for annual inspections of the job performance of each logging supervisor to ensure that the agency's regulations, license requirements, and the applicant's operating and emergency procedures are followed. Inspection records shall be retained for three years after each annual internal inspection.

5. The applicant shall submit a description of its overall organizational structure as it applies to the radiation safety responsibilities in well logging, including specified delegations of authority and responsibility.

6. If an applicant wants to perform leak testing of sealed sources, the applicant shall identify the manufacturers and the model numbers of the leak test kits to be used. If the applicant wants to analyze its own wipe samples, the applicant shall establish procedures to be followed and submit a description of these procedures to the agency. The description must include the following:

a. Instruments to be used;

b. Methods of performing the analysis; and

c. Pertinent experience of the person who will analyze the wipe samples.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 2 Prohibition

12VAC5-481-3160 Agreement with well owner

Article 2 Prohibition

A. No licensee shall perform wireline service operations with a sealed source(s) unless, prior to commencement of the operation, the licensee has a written agreement with the well operator, well owner, drilling contractor, or land owner that:

1. In the event a sealed source is lodged downhole, a reasonable effort at recovery will be made;

2. No person may attempt to recover a sealed source in a manner which, in the licensee's opinion, could result in its rupture;

3. In the event a decision is made to abandon the sealed source downhole, the requirements of 12VAC5-481-3370 C shall be met;

4. The radiation monitoring required in 12VAC5-481-3340 will be performed; and

5. If the environment, any equipment, or personnel are contaminated with licensed material, they must be decontaminated before release from the site or release for unrestricted use.

B. The licensee shall retain a copy of the written agreement for three years after the completion of the well logging operation.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 25, Issue 2, eff. November 1, 2008.

Article 3 Equipment Control

12VAC5-481-3170 Limits on levels of radiation

Article 3 Equipment Control

Sources of radiation shall be used, stored, and transported in such a manner that the transportation requirements of Part XIII (12VAC5-481-2950 et seq.) of this chapter and the dose limitation requirements of Part IV (12VAC5-481-600 et seq.) of this chapter are met.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-3180 Storage precautions

A. Each source of radiation, except accelerators, shall be provided with a storage or transport container. The container shall be provided with a lock, or tamper seal for calibration sources, to prevent unauthorized removal of, or exposure to, the source of radiation.

B. Sources of radiation shall be stored in a manner that will minimize danger from explosion or fire.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-3190 Transport precautions

Transport containers shall be physically secured to the transporting vehicle to prevent accidental loss, tampering, or unauthorized removal.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-3200 Radiation survey instruments

A. The licensee or registrant shall maintain sufficient calibrated and operable radiation survey instruments at each field station to make physical radiation surveys as required by this part and by Part IV (12VAC5-481-600 et seq.). Instrumentation shall be capable of measuring 0.001 mSv (0.1 mrem) per hour through at least 0.5 mSv (50 mrem) per hour.

B. Each radiation survey instrument shall be calibrated:

1. At intervals not to exceed six months and after each instrument servicing;

2. For linear scale instruments, at two points located approximately 25% and 75% of full-scale on each scale; for logarithmic scale instruments, at midrange of each decade, and at two points of at least one decade; and for digital instruments, at appropriate points; and

3. So that accuracy within 20% of the true radiation level can be demonstrated on each scale.

C. Calibration records shall be maintained for a period of three years.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3210 Leak testing of sealed sources

A. Requirements. Each licensee using sealed sources of radioactive material shall have the sources tested for leakage. Records of leak test results shall be kept in units of becquerels (microcuries) and maintained for three years after the leak test is performed.

B. Method of Testing. Tests for leakage shall be performed only by persons specifically authorized to perform such tests by the agency, the NRC, or another agreement state. The test sample shall be taken from the surface of the source, source holder, or from the surface of the device in which the source is stored or mounted and on which one might expect contamination to accumulate. The test sample shall be analyzed for radioactive contamination, and the analysis shall be capable of detecting the presence of 185 Bq (0.005 μCi) of radioactive material on the test sample.

C. Interval of Testing. Each sealed source (except an energy compensated source (ECS)) shall be tested at intervals not to exceed six months. Each ECS that is not exempt in subsection E of this section must be tested at intervals not to exceed three years. In the absence of a certificate from a transferor indicating that a test has been made prior to the transfer, the sealed source shall not be put into use until tested. If, for any reason, it is suspected that a sealed source may be leaking, it shall be removed from service immediately and tested for leakage as soon as practical.

D. Leaking or Contaminated Sources. If the test reveals the presence of 185 Bq (0.005 μCi) or more of leakage or contamination, the licensee shall immediately withdraw the source from use and shall cause it to be decontaminated, repaired, or disposed of in accordance with these regulations. The licensee shall check the equipment associated with the leaking source for radioactive contamination and, if contaminated, have it decontaminated or disposed of in accordance with these regulations. A report describing the equipment involved, the test results, and the corrective action taken shall be filed with the agency within five days of receiving the test results.

E. Exemptions. The following sources are exempted from the periodic leak test requirements of subsections A through D of this section:

1. Hydrogen-3 sources;

2. Sources of radioactive material with a half-life of 30 days or less;

3. Sealed sources of radioactive material in gaseous form;

4. Sources of beta- or gamma-emitting radioactive material with an activity of 3.7 MBq (100 μCi) or less; and

5. Sources of alpha-emitting radioactive material with an activity of 0.37 MBq (10 μCi) or less.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Errata, 34:8 VA.R. 832 December 11, 2017.

12VAC5-481-3220 Physical inventory

Each licensee or registrant shall conduct a semi-annual physical inventory to account for all sources of radiation. Records of inventories shall be maintained for three years from the date of the inventory and shall include the quantities and kinds of sources of radiation, the location the date of the inventory, and the name of the individual conducting the inventory.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3230 Utilization records

Each licensee or registrant shall maintain current records, which shall be kept available for three years from the date of the recorded event, showing the following information for each source of radiation:

1. Make, model number, and a serial number or a description of each source of radiation used;

2. The identity of the well-logging supervisor responsible for the source and the logging assistant present;

3. Locations where used and dates of use; and

4. In the case of tracer materials and radioactive markers, the utilization record shall indicate the radionuclide and activity used in a particular well.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3240 Design, performance, and certification criteria for sealed sources used in downhole operations

A. Each sealed source, except those containing radioactive material in gaseous form, and ECSs used in downhole operations, shall meet the following minimum criteria:

1. Be of doubly encapsulated construction;

2. Contain radioactive material whose chemical and physical forms are as insoluble and nondispersible as practical; and

3. Certified by one of the following methods:

a. For a sealed source manufactured on or before July 14,1989, a licensee may use the sealed source, for use in well-logging applications if it meets the requirements of USASI N5.10-1968, "Classification of Sealed Radioactive Sources," or the requirements in subdivision 3 b or c of this subsection;

b. For a sealed source manufactured after July 1989, a licensee may use the sealed source, for use in well-logging applications if it meets the oil well-logging requirements of ANSI/HPS N43.6-1997, "Sealed Radioactive Sources-Classification"; or

c. For a sealed source manufactured after July 14, 1989, a licensee may use the sealed source, for use in well-logging applications, if the sealed source's prototype has been tested and found to maintain its integrity after each of the following tests:

(1) Temperature. The test source must be held at -40°C for 20 minutes, 600°C for 1 hour, and then be subject to a thermal shock test with a temperature drop from 600°C to 20°C within 15 seconds.

(2) Impact test. A 5 kg steel hammer, 2.5 cm in diameter, must be dropped from a height of 1 m onto the test source.

(3) Vibrations test. The test source must be subject to a vibration from 25 Hz to 500 Hz at 5 g amplitude for 30 minutes.

(4) Puncture test. A 1 gram hammer and pin, 0.3 cm pin diameter, must be dropped from a height of 1 m onto the test source.

(5) Pressure test. The test source must be subject to an external pressure of 1.695 x 10⁷ pascals (24,600 pounds per square inch absolute).

B. Certification documents shall be maintained for inspection by the agency for a period of two years after source disposal. If the source is abandoned downhole, the certification documents shall be maintained until the agency authorizes disposition.

C. Energy Compensated Source (ECS). Licensee use of an ECS, which may contain no greater than 3.7 MBq (100 μCi), is exempt from this part, except the following:

1. For well-logging applications with a surface casing for protecting fresh water aquifers, use of the ECS is only subject to the requirements of 12VAC5-481-3210, 12VAC5-481-3220 and 12VAC5-481-3230.

2. For well-logging applications without a surface casing for protecting fresh water aquifers, use of the ECS is only subject to the requirements of 12VAC5-481-3160, 12VAC5-481-3210, 12VAC5-481-3220, 12VAC5-481-3230, subsection D of this section and 12VAC5-481-3370.

3. ECSs must be registered with the NRC under 10 CFR 32.210 or with an agreement state.

D. Use of a sealed source in a well without a surface casing. The licensee may use a sealed source in a well without a surface casing for protecting fresh water aquifers only if the licensee follows a procedure for reducing the probability of the source becoming lodged in the well. The procedure must be approved by the agency pursuant to 12VAC5-481-3151 A 3.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3241 Tritium neutron generator target sources

A. Use of a tritium neutron generator target source, containing quantities not exceeding 1,110 GBq (30 curies) and in a well with a surface casing to protect fresh water aquifers, is subject to the requirements of this part except 12VAC5-481-3160, 12VAC5-481-3240 and 12VAC5-481-3370.

B. Use of a tritium neutron generator target source, containing quantities exceeding 1,110 GBq (30 curies) or in a well without a surface casing to protect fresh water aquifers, is subject to the requirements of this part except 12VAC5-481-3240.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3250 Labeling

A. Each source, source holder, or logging tool containing radioactive material shall bear a durable, legible, and clearly visible marking or label, that has, as a minimum, the standard radiation caution symbol, without the conventional color requirement, and the following wording:

DANGER or CAUTION

RADIOACTIVE MATERIAL

This labeling shall be on the smallest component transported as a separate piece of equipment.

B. Each transport container shall have permanently attached to it a durable, legible, and clearly visible label which has, as a minimum, the standard radiation caution symbol and the following wording:

DANGER or CAUTION

RADIOACTIVE MATERIAL

NOTIFY CIVIL AUTHORITIES (OR NAME OF COMPANY)

C. Uranium sinker bars used in well-logging applications shall be legibly impressed with the following words:

CAUTION

RADIOACTIVE DEPLETED URANIUM

NOTIFY CIVIL AUTHORITIES (OR NAME OF COMPANY) IF FOUND

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3260 Inspection and maintenance

A. Each licensee shall visually check source holders, logging tools, and source handling tools, for defects before each use to ensure that the equipment is in good working condition and that required labeling is present. If defects are found, the equipment must be removed from service until repaired, and a record must be made listing: the date of check, name of inspector, equipment involved, defects found, and repairs made. These records must be retained for three years after the defect is found.

B. Each licensee or registrant shall conduct, at intervals not to exceed six months, a program of inspection and maintenance of source holders, logging tools, source handling tools, storage containers, transport containers, and injection tools to assure proper labeling and physical condition. Records of inspection and maintenance shall be maintained for a period of three years.

C. If any inspection conducted pursuant to subsection B of this section reveals damage to labeling or components critical to radiation safety, the device shall be removed from service until repairs have been made.

D. If a sealed source is stuck in the source holder, the licensee shall not perform any operation, such as drilling, cutting, or chiseling, on the source holder unless the licensee is specifically approved by the agency, NRC, or another agreement state to perform this operation.

E. The repair, opening, or modification of any sealed source shall be performed only by persons specifically authorized to do so by the agency, the NRC, or another agreement state.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3261 Radioactive markers

The licensee may use radioactive markers in wells only if the individual markers contain quantities of licensed material not exceeding the quantities specified in 12VAC5-481-3730. The use of markers is subject only to the requirements of 12VAC5-481-3220.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3262 Uranium sinker bars

The licensee may use a uranium sinker bar in well logging applications only if it is legibly impressed with the words "CAUTION -- RADIOACTIVE -- DEPLETED URANIUM" and "NOTIFY CIVIL AUTHORITIES (or COMPANY NAME) IF FOUND."

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016.

Article 4 Requirements for Personal Safety

12VAC5-481-3270 Training requirements

Article 4 Requirements for Personal Safety

A. No licensee shall permit any individual to act as a logging supervisor as defined in this part until such individual has:

1. Received instruction in the following and demonstrated an understanding thereof:

a. Fundamentals of radiation safety including:

(1) Characteristics of radiation;

(2) Units of radiation dose and quantity of radioactivity;

(3) Hazards of exposure to radiation;

(4) Levels of radiation from licensed material;

(5) Methods of controlling radiation dose (time, distance, and shielding); and

(6) Radiation safety practices, including prevention of contamination, and methods of decontamination;

b. Radiation detection instruments including:

(1) Use, operation, calibration, and limitations of radiation survey instruments;

(2) Survey techniques; and

(3) Use of personnel monitoring equipment;

c. Equipment to be used including:

(1) Operation of equipment, including source handling equipment and remote handling tools;

(2) Storage, control, and disposal of licensed material; and

(3) Maintenance of equipment;

d. The requirements of pertinent Virginia regulations; and

e. Case histories of accidents in well logging;

2. Received copies of and instruction in the regulations contained in this part and the applicable sections of Parts I (12VAC5-481-10 et seq.), IV (12VAC5-481-600 et seq.), and X (12VAC5-481-2250 et seq.) of this chapter or their equivalent, conditions of appropriate license, and the licensee's operating and emergency procedures, and demonstrated an understanding thereof;

3. Demonstrated competence to use sources of radiation, related handling tools, and radiation survey instruments which will be used on the job by a field evaluation; and

4. Demonstrated understanding of subdivisions 1 and 2 of this subsection by successfully passing a written test.

B. No licensee or registrant shall permit any individual to act as a logging assistant until such individual has:

1. Received instruction in the applicable sections of Parts I (12VAC5-481-10 et seq.), IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter or their equivalent;

2. Received copies of, and instruction in the licensee's operating and emergency procedures;

3. Demonstrated understanding of subdivisions 1 and 2 of this subsection by successfully passing a written or oral test; and

4. Demonstrated competence to use, under the personal supervision of the logging supervisor, the sources of radiation, related handling tools, and radiation survey instruments that will be used on the job.

C. The licensee shall provide safety reviews at least once during each calendar year.

D. The licensee shall maintain employee training records for three years following termination of the individual's employment.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3280 Operating and emergency procedures

The licensee's or registrant's operating and emergency procedures shall include instructions in at least the following:

1. Handling and use of sources of radiation to be employed so that no individual is likely to be exposed to radiation doses in excess of the standards established in Part IV (12VAC5-481-600 et seq.) of this chapter;

2. Methods and occasions for conducting radiation surveys;

3. Methods and occasions for locking and securing sources of radiation;

4. Personnel monitoring and the use of personnel monitoring equipment;

5. Transportation to temporary jobsites and field stations, including the packaging and placing of sources of radiation in vehicles, placarding of vehicles, and securing sources of radiation during transportation;

6. Minimizing exposure of individuals in the event of an accident;

7. Procedure for notifying proper personnel in the event of an accident;

8. Maintenance of records;

9. Use, inspection and maintenance of source holders, logging tools, source handling tools, storage containers, transport containers, and injection tools;

10. Procedure to be followed in the event a sealed source is lodged downhole;

11. Procedures to be used for picking up, receiving, and opening packages containing radioactive material;

12. For the use of tracers, decontamination of the environment, equipment, and personnel;

13. Maintenance of records generated by logging personnel at temporary jobsites;

14. Notifying proper persons in the event of an accident; and

15. Actions to be taken if a sealed source is ruptured, including actions to prevent the spread of contamination and minimize inhalation and ingestion of radioactive material and actions to obtain suitable radiation survey instruments as required by 12VAC5-481-3200.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-3290 Personnel monitoring

A. No licensee shall permit any individual to act as a logging supervisor or a logging assistant unless each such individual wears a personnel dosimeter at all times during the handling of licensed radioactive materials. Each personnel dosimeter shall be assigned to and worn by only one individual. Film badges must be replaced at least monthly and all other personnel dosimeters that require replacement must be replaced at least quarterly. All personnel dosimeters must be evaluated at least quarterly or promptly after replacement, whichever is more frequent.

B. Personnel monitoring records shall be maintained for inspection until the agency authorizes disposition.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 37, Issue 25, eff. January 14, 2022.

Article 5 Precautionary Procedures in Logging and Subsurface Tracer Studies

12VAC5-481-3300 Security

Article 5 Precautionary Procedures in Logging and Subsurface Tracer Studies

A. A logging supervisor must be physically present at a temporary job site whenever licensed materials are being handled or are not stored and locked in a vehicle or storage place. The logging supervisor may leave the job site to obtain assistance if a source becomes lodged in a well.

B. During well logging, except when radiation sources are below ground or in shipping or storage containers, the logging supervisor or other individual designated by the logging supervisor must maintain direct surveillance of the operation to prevent unauthorized entry into a restricted area as defined in 12VAC5-481-10.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3310 Handling tools

The licensee shall provide and require the use of tools that will assure remote handling of sealed sources other than low-activity calibration sources.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-3320 Subsurface tracer studies

A. Protective gloves and other appropriate protective clothing and equipment shall be used by all personnel handling radioactive tracer material. Precautions shall be taken to avoid ingestion or inhalation of radioactive material.

B. No licensee shall cause the injection of radioactive material into potable aquifers without prior written authorization from the agency.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-3330 Particle accelerators

No licensee or registrant shall permit above-ground testing of particle accelerators, designed for use in well-logging, which results in the production of radiation, except in areas or facilities so controlled or shielded that the requirements of 12VAC5-481-630 and 12VAC5-481-640, as applicable, are met.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

Article 6 Radiation Surveys and Records

12VAC5-481-3340 Radiation surveys and contamination control

Article 6 Radiation Surveys and Records

A. Radiation surveys or calculations shall be made and recorded for each area where radioactive materials are used and stored.

B. Radiation surveys shall be made and recorded for the radiation levels in occupied positions and on the exterior of each vehicle used to transport radioactive material. Such surveys shall include each source of radiation or combination of sources to be transported in the vehicle.

C. If the sealed source assembly is removed from the logging tool before departing the jobsite, the logging tool detector shall be energized, or a survey meter used, to assure that the logging tool is free of contamination.

D. Radiation surveys shall be made and recorded at the jobsite or well-head for each tracer operation, except those using hydrogen-3, carbon-14, and sulfur-35. These surveys shall include measurements of radiation levels before and after the operation.

E. Records required pursuant to subsections A through D of this section shall include the dates, the identification of individual(s) making the survey, the identification of survey instrument(s) used, and an exact description of the location of the survey. Records of these surveys shall be maintained for three years after completion of the survey.

F. If the licensee detects evidence that a sealed source has ruptured or licensed materials have caused contamination, the licensee shall initiate immediately the emergency procedures required by 12VAC5-481-3280 and contact the agency immediately.

G. During efforts to recover a sealed source lodged in the well, the licensee shall continuously monitor, with an appropriate radiation detection instrument or a logging tool with a radiation detector, the circulating fluids from the well, if any, to check for contamination resulting from damage to the sealed source.

H. If contamination results from the use of licensed material in well logging, the licensee shall decontaminate all work area equipment and personnel before release from the site or release for unrestricted use.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3350 Documents and records required at field stations

Each licensee shall maintain the following documents and records for the specific devices and sources used at the field station:

1. Appropriate license, certificate of registration, or equivalent document(s);

2. Operating and emergency procedures;

3. Copy of Part IV (12VAC5-481-600 et seq.), Part X (12VAC5-481-2250 et seq.) and this part;

4. Records of the latest survey instrument calibrations pursuant to 12VAC5-481-3200;

5. Records of the latest leak test results pursuant to 12VAC5-481-3210;

6. Records of physical inventories required pursuant to 12VAC5-481-3220;

7. Utilization records required pursuant to 12VAC5-481-3230;

8. Records of inspection and maintenance required pursuant to 12VAC5-481-3260;

9. Survey records required pursuant to 12VAC5-481-3340; and

10. Training records required pursuant to 12VAC5-481-3270.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3360 Documents and records required at temporary jobsites

Each licensee or registrant conducting operations at a temporary jobsite shall have the following documents and records available at that site for inspection by the agency:

1. Operating and emergency procedures;

2. Survey records required pursuant to 12VAC5-481-3340 for the period of operation at the site;

3. Evidence of current calibration for the radiation survey instruments in use at the site;

4. When operating in the state under reciprocity, a copy of the appropriate license, certificate of registration, or equivalent document(s); and

5. Shipping papers for the transportation of radioactive material.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

Article 7 Notification

12VAC5-481-3370 Notification of incidents, abandonment, and lost sources

Article 7 Notification

A. Notification of incidents and sources lost in other than downhole logging operations shall be made in accordance with appropriate provisions of Part IV (12VAC5-481-600 et seq.) of this chapter.

B. Whenever a sealed source or device containing radioactive material is lodged downhole, the licensee shall:

1. Monitor at the surface for the presence of radioactive contamination with a radiation survey instrument or logging tool during logging tool recovery operations; and

2. Notify the agency immediately by telephone and subsequently, within 30 days, by confirmatory letter if the licensee knows or has reason to believe that a sealed source has been ruptured. This letter shall identify the well or other location, describe the magnitude and extent of the escape of radioactive material, assess the consequences of the rupture, and explain efforts planned or being taken to mitigate these consequences.

C. When it becomes apparent that efforts to recover the radioactive source will not be successful, the licensee shall:

1. Advise the well-operator of the regulations of the Virginia Department of Mines, Minerals, and Energy; Division of Gas and Oil, regarding abandonment and an appropriate method of abandonment, that shall include:

a. The immobilization and sealing in place of the radioactive source with a cement plug,

b. The setting of a whipstock or other deflection device, and

c. The mounting of a permanent identification plaque at the surface of the well, containing the appropriate information required by subsection D of this section;

2. Notify the agency by telephone, giving the circumstances of the loss, and request approval of the proposed abandonment procedures; and

3. File a written report with the agency within 30 days of the abandonment. The licensee shall send a copy of the report to the Virginia Department of Mines, Minerals, and Energy; Division of Gas and Oil. The report shall contain the following information:

a. Date of occurrence;

b. A description of the well logging source involved, including the radionuclide and its quantity, chemical, and physical form;

c. Surface location and identification of the well;

d. Results of efforts to immobilize and seal the source in place;

e. A brief description of the attempted recovery effort;

f. Depth of the source;

g. Depth of the top of the cement plug;

h. Depth of the well;

i. Any other information, such as a warning statement, contained on the permanent identification plaque; and

j. The names of state agencies receiving a copy of this report.

D. Whenever a sealed source containing radioactive material is abandoned downhole, the licensee shall provide a permanent plaque for posting the well or well-bore. This plaque shall:

1. Be constructed of long-lasting material, such as stainless steel or monel; and

2. Contain the following information engraved on its face:

a. The word "CAUTION";

b. The radiation symbol without the conventional color requirement;

c. The date of abandonment;

d. The name of the well operator or well owner;

e. The well name and well identification number(s) or other designation;

f. The sealed source(s) by radionuclide and activity;

g. The source depth and the depth to the top of the plug; and

h. An appropriate warning, depending on the specific circumstances of each abandonment.

E. The licensee shall immediately notify the agency by telephone and subsequently by confirming letter if the licensee knows or has reason to believe that radioactive material has been lost in or to an underground potable aquifer. Such notice shall designate the well location and shall describe the magnitude and extent of loss of radioactive material, assess the consequences of such loss, and explain efforts planned or being taken to mitigate these consequences.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-3380 Purpose and scope

A. This part establishes requirements, for which the registrant is responsible, for use of therapeutic radiation machines. The provisions of this part are in addition to, and not in substitution for, other applicable provisions of these regulations.

B. The use of therapeutic radiation machines shall be by, or under the supervision of, a licensed practitioner of the healing arts who meets the training/experience criteria established by 12VAC5-481-3390 C.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-3390 General administrative requirements for facilities using therapeutic radiation machines

A. Administrative controls. The registrant shall be responsible for directing the operation of the therapeutic radiation machines that have been registered with the agency. The registrant or the registrant's agent shall ensure that the requirements of Part XV (12VAC5-481-3380 et seq.) of this chapter are met in the operation of the therapeutic radiation machines.

B. A therapeutic radiation machine that does not meet the provisions of this chapter shall not be used for irradiation of patients.

C. Training for external beam radiation therapy authorized users. The registrant for any therapeutic radiation machine subject to 12VAC5-481-3420 or 12VAC5-481-3430 shall require the authorized user to be a physician who:

1. Is certified in:

a. Radiation oncology or therapeutic radiology by the American Board of Radiology or radiology (combined diagnostic and therapeutic radiology program) by the American Board of Radiology prior to 1976;

b. Radiation oncology by the American Osteopathic Board of Radiology;

c. Radiology, with specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or

d. Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons;

or

2. Is in the active practice of therapeutic radiology, and has completed 200 hours of instruction in basic radiation techniques applicable to the use of an external beam radiation therapy unit, 500 hours of supervised work experience, and a minimum of three years of supervised clinical experience.

a. To satisfy the requirement for instruction, the classroom and laboratory training shall include:

(1) Radiation physics and instrumentation;

(2) Radiation protection;

(3) Mathematics pertaining to the use and measurement of ionization radiation; and

(4) Radiation biology.

b. To satisfy the requirement for supervised work experience, training shall be under the supervision of an authorized user and shall include:

(1) Review of the full calibration measurements and periodic quality assurance checks;

(2) Evaluation of prepared treatment plans and calculation of treatment times and patient treatment settings;

(3) Using administrative controls to prevent misadministrations;

(4) Implementing emergency procedures to be followed in the event of the abnormal operation of an external beam radiation therapy unit or console; and

(5) Checking and using radiation survey meters.

c. To satisfy the requirement for a period of supervised clinical experience, training shall include one year in a formal training program approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association and an additional two years of clinical experience in therapeutic radiology under the supervision of an authorized user. The supervised clinical experience shall include:

(1) Examining individuals and reviewing their case histories to determine their suitability for external beam radiation therapy treatment, and any limitations or contraindications;

(2) Selecting proper dose and how it is to be administered;

(3) Calculating the external beam radiation therapy doses and collaborating with the authorized user in the review of patients' progress and consideration of the need to modify originally prescribed doses or treatment plans as warranted by patients' reaction to radiation; and

(4) Post-administration follow-up and review of case histories.

3. Notwithstanding the requirements of subdivisions 1 and 2 of this subsection, the registrant for any therapeutic radiation machine subject to 12VAC5-481-3420 may also submit the training of the prospective authorized user physician for agency review on a case-by-case basis.

4. A physician shall not act as an authorized user for any therapeutic radiation machine until such time as said physician's training has been reviewed and approved by the agency.

D. Training for qualified medical physicist. The registrant for any therapeutic radiation machine subject to 12VAC5-481-3420 and 12VAC5-481-3430 shall require the qualified medical physicist to be registered with the agency, under the provisions of Part II (12VAC5-481-260 et seq.) of this chapter, as a provider of radiation services in the area of calibration and surveys of external beam radiation therapy units and to:

1. Be certified by the American Board of Radiology in:

a. Therapeutic radiological physics;

b. Roentgen-ray and gamma-ray physics;

c. X-ray and radium physics; or

d. Radiological physics;

2. Be certified by the American Board of Medical Physics in Radiation Oncology Physics;

3. Be certified by the Canadian College of Medical Physics; or

4. Hold a master's or doctor's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university and have completed one year of full-time training in medical physics and an additional year of full-time work experience under the supervision of a qualified medical physicist at a medical institution. This training and work experience shall be conducted in clinical radiation facilities that provide high-energy external beam radiation therapy (photons and electrons with energies greater than or equal to one MV/one MeV). To meet this requirement, the individual shall have performed the tasks listed in 12VAC5-481-3400 A, 12VAC5-481-3420 P, 12VAC5-481-3420 Q, 12VAC5-481-3430 T, and 12VAC5-481-3430 U under the supervision of a qualified medical physicist during the year of work experience.

E. Qualifications of operators.

1. Individuals who will be operating a therapeutic radiation machine for medical use shall be American Registry of Radiologic Technologists (ARRT) Registered Radiation Therapy Technologists. Individuals who are not ARRT Registered Radiation Therapy Technologists shall submit evidence that they have satisfactorily completed a radiation therapy technologist training program that complies with the requirements of the Joint Review Committee on Education in Radiologic Technology.

2. The names and training of all personnel currently operating a therapeutic radiation machine shall be kept on file at the facility. Information on former operators shall be retained for a period of at least two years beyond the last date they were authorized to operate a therapeutic radiation machine at that facility.

F. Written safety procedures and rules shall be developed by a qualified medical physicist and shall be available in the control area of a therapeutic radiation machine, including any restrictions required for the safe operation of the particular therapeutic radiation machine. The operator shall be able to demonstrate familiarity with these rules.

G. Individuals shall not be exposed to the useful beam except for medical therapy purposes and unless such exposure has been ordered in writing by a therapeutic radiation machine authorized user. This provision specifically prohibits deliberate exposure of an individual for training, demonstration or other non-healing-arts purposes.

H. Visiting authorized user. Notwithstanding the provisions of subsection G of this section, a registrant may permit any physician to act as a visiting authorized user under the term of the registrant's Certificate of Registration for up to 60 days per calendar year under the following conditions:

1. The visiting authorized user has the prior written permission of the registrant's management and, if the use occurs on behalf of an institution, the institution's radiation safety committee, where applicable; and

2. The visiting authorized user meets the requirements established for an authorized user in subdivisions C 1 and C 2 of this section; and

3. The registrant shall maintain copies of the written permission required in subdivision 1 of this subsection and documentation that the visiting authorized user met the requirements of subdivision 2 of this subsection for five years from the date of the last visit.

I. All individuals associated with the operation of a therapeutic radiation machine shall be instructed in and shall comply with the provisions of the registrant's quality management program. In addition to the requirements of Part XV of this chapter, these individuals are also subject to the requirements of 12VAC5-481-640, 12VAC5-481-680, and 12VAC5-481-760.

J. Information and maintenance record and associated information. The registrant shall maintain the following information in a separate file or package for each therapeutic radiation machine, for inspection by the agency:

1. Report of acceptance testing;

2. Records of all surveys, calibrations, and periodic quality assurance checks of the therapeutic radiation machine required by Part XV of this chapter, as well as the names of persons who performed such activities;

3. Records of maintenance or modifications performed on the therapeutic radiation machine after September 20, 2006, as well as the names of persons who performed such services;

4. Signature of person authorizing the return of therapeutic radiation machine to clinical use after service, repair, or upgrade.

K. Records retention. All records required by Part XV of this chapter shall be retained until disposal is authorized by the agency unless another retention period is specifically authorized in Part XV of this chapter. All required records shall be retained in an active file from at least the time of generation until the next agency inspection. Any required record generated prior to the last agency inspection may be microfilmed or otherwise archived as long as a complete copy of said record can be retrieved until such time as the agency authorizes final disposal.

History

• Statutory Authority: §§ 32.1-12 and 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 32, Issue 17, eff. June 5, 2016.

12VAC5-481-3400 General technical requirements for facilities using therapeutic radiation machines

A. Protection surveys.

1. The registrant shall ensure that radiation protection surveys of all new facilities and existing facilities not previously surveyed are performed with an operable radiation measurement survey instrument calibrated in accordance with 12VAC5-481-3440. The radiation protection survey shall be performed by, or under the direction of, a qualified medical physicist or a qualified inspector and shall verify that, with the therapeutic radiation machine in a "BEAM-ON" condition, with the largest clinically available treatment field, and with a scattering phantom in the useful beam of radiation:

a. Radiation levels in restricted areas are not likely to cause personnel exposures in excess of the limits specified in 12VAC5-481-640; and

b. Radiation levels in unrestricted areas do not exceed the limits specified in 12VAC5-481-720.

2. In addition to the requirements of subdivision 1 of this subsection, a radiation protection survey shall also be performed prior to any subsequent medical use and:

a. After making any change in the treatment room shielding;

b. After making any change in the location of the therapeutic radiation machine within the treatment room;

c. After relocating the therapeutic radiation machine; or

d. Before using the therapeutic radiation machine in a manner that could result in increased radiation levels in areas outside the external beam radiation therapy treatment room.

3. The survey record shall indicate all instances where the facility, in the opinion of the qualified medical physicist or a qualified inspector, is in violation of applicable regulations. The survey record shall also include the date of the measurements, the reason the survey is required, the manufacturer's name, the model number and serial number of the therapeutic radiation machine, the instruments used to measure radiation levels, a plan of the areas surrounding the treatment room that were surveyed, the measured dose rate at several points in each area expressed in microsieverts or millirems per hour, the calculated maximum level of radiation over a period of one week for each restricted and unrestricted area, and the signature of the individual responsible for conducting the survey;

4. If the results of the surveys required by subdivision 1 or 2 of this subsection indicate any radiation levels in excess of the respective limit specified in subdivision 1 of this subsection, the registrant shall lock the control in the "OFF" position and not use the unit:

a. Except as may be necessary to repair, replace, or test the therapeutic radiation machine, the therapeutic radiation machine shielding, or the treatment room shielding; or

b. Until the registrant has received a specific exemption from the agency.

B. Modification of radiation therapy unit or room before beginning a treatment program. If the survey required by subsection A of this section indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by 12VAC5-481-720, before beginning the treatment program the registrant shall:

1. Either equip the unit with beam direction interlocks or add additional radiation shielding to ensure compliance with 12VAC5-481-720;

2. Perform the survey required by subsection A of this section again; and

3. Include in the report required by subsection D of this section the results of the initial survey, a description of the modification made to comply with subdivision 1 of this subsection, and the results of the second survey; or

4. Request and receive a registration amendment under 12VAC5-481-720 that authorizes radiation levels in unrestricted areas greater than those permitted by 12VAC5-481-720.

C. Dosimetry equipment.

1. The registrant shall have a calibrated dosimetry system available for use. The system shall have been calibrated by the National Institute for Standards and Technology (NIST) or by an American Association of Physicists in Medicine (AAPM) Accredited Dosimetry Calibration Laboratory (ADCL). The calibration shall have been performed within the previous 24 months and after any servicing that may have affected system calibration. An independent survey shall be conducted by a qualified inspector or qualified medical physicist other than the person performing the original survey prior to the equipment being used except as described in subsection A of this section:

a. For beams with energies greater than one MV (1 MeV), the dosimetry system shall have been calibrated for Cobalt-60;

b. For beams with energies equal to or less than one MV (1 MeV), the dosimetry system shall have been calibrated at an energy (energy range) appropriate for the radiation being measured;

2. The registrant shall have available for use a dosimetry system for quality assurance check measurements. To meet this requirement, the system may be compared with a system that has been calibrated in accordance with subdivision 1 of this subsection. This comparison shall have been performed within the previous 12 months and after each servicing that may have affected system calibration. The quality assurance check system may be the same system used to meet the requirement in subdivision 1 of this subsection;

3. The registrant shall maintain a record of each dosimetry system calibration, intercomparison, and comparison for the duration of the license or registration. For each calibration, intercomparison, or comparison, the record shall include: the date; the model numbers and serial numbers of the instruments that were calibrated, inter-compared, or compared as required by subdivisions 1 and 2 of this subsection; the correction factors that were determined; the names of the individuals who performed the calibration, intercomparison, or comparison; and evidence that the intercomparison was performed by, or under the direct supervision and in the physical presence of, a qualified medical physicist.

D. Reports of external beam radiation therapy surveys and measurements. The registrant for any therapeutic radiation machine subject to 12VAC5-481-3420 or 12VAC5-481-3430 shall furnish a copy of the records required in subsections A and B of this section to the agency within 30 days following completion of the action that initiated the record requirement.

History

• Statutory Authority: §§ 32.1-12 and 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 17, eff. June 5, 2016.

12VAC5-481-3410 Quality management program

Each registrant or applicant subject to 12VAC5-481-3420 and 12VAC5-481-3430 shall develop, implement, and maintain a quality management program to provide high confidence that radiation will be administered as directed by the authorized user.

A. Scope and applicability. The quality management program shall address, at a minimum, the following specific objectives:

1. Written directives.

a. A written directive shall be dated and signed by an authorized user prior to the administration of radiation. If because of the patient's condition a delay caused by providing a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive will be acceptable, provided that the oral revision is documented as soon as possible in writing in the patient's record and a revised written directive is signed by an authorized user within 48 hours of the oral revision.

b. The written directive shall contain the patient's or human research subject's name, type and energy of the beam, total dose, dose per fraction, treatment site, and number of fractions.

c. A written revision to an existing written directive may be made provided that the revision is dated and signed by an authorized user prior to the administration of the therapeutic radiation machine dose or the next fractional dose.

d. The registrant shall retain a copy of the written directive for three years.

2. Procedures for administrations. The registrant shall develop, implement, and maintain written procedures to provide high confidence that:

a. Prior to the administration of each course of radiation treatment, the patient's or human research subject's identity is verified by more than one method as the individual named in the written directive;

b. Each administration is in accordance with the written directive;

c. Therapeutic radiation machine final plans of treatment and related calculations are in accordance with the respective written directives by:

(1) Checking both manual and computer-generated dose calculations to verify they are correct and in accordance with the written directive; and

(2) Verifying that any computer-generated calculations are correctly transferred into the consoles of authorized therapeutic medical units;

d. Any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken; and

e. The registrant retains a copy of the procedures for administrations for the duration of the registration.

B. Reports and notifications of misadministrations.

1. A registrant shall report any event resulting from the treatment of a patient or human research subject in which the administration of therapeutic radiation machine radiation results, or will result in, unintended permanent functional damage to an organ or a physiological system as determined by a physician.

2. Other than events that result from the treatment of a patient or human research subject, a registrant shall report any event in which the administration of a therapeutic radiation machine therapy dose:

a. Involves the wrong patient, wrong treatment modality, or wrong treatment site;

b. The calculated weekly administered dose differs from the weekly prescribed dose by more than 30%; or

c. The calculated total administered dose differs from the total prescribed dose by more than 20% of the total prescribed dose.

3. The registrant shall notify the agency by telephone no later than the next calendar day after the discovery of a misadministration.

4. The registrant shall submit a written report to the agency within 15 days after the discovery of a misadministration. The written report shall include:

a. The registrant's name;

b. The name of the prescribing physician;

c. A brief description of the event;

d. Why the event occurred;

e. The effect, if any, on the individual who received the misadministration;

f. Actions, if any, that have been taken or are planned to prevent recurrence; and

g. Certification that the registrant notified the individual, or the individual's responsible relative or guardian, and if not, why not.

5. The report shall not contain the individual's name or any other information that could lead to the identification of the individual.

6. The registrant shall provide notification of the event to the referring physician and also notify the individual who is the subject of the misadministration no later than 24 hours after its discovery, unless the referring physician personally informs the registrant either that he will inform the individual or that, based on medical judgment, telling the individual would be harmful. The registrant is not required to notify the individual without first consulting the referring physician. If the referring physician or the affected individual cannot be reached within 24 hours, the registrant shall notify the individual as soon as possible thereafter. The registrant may not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the misadministration, because of any delay in notification. To meet the requirements of this subdivision, the notification of the individual who is the subject of the misadministration may be made instead to that individual's responsible relative or guardian. If a verbal notification is made, the registrant shall inform the individual, or appropriate responsible relative or guardian, that a written description of the event can be obtained from the registrant upon request. The registrant shall provide such a written description if requested.

7. Aside from the notification requirement, nothing in this section affects any rights or duties of registrants and physicians in relation to each other, to individuals affected by the misadministration, or to that individual's responsible relatives or guardians.

8. The registrant shall retain a record of a misadministration in accordance with subsection C of this section. A copy of the required record shall be provided to the referring physician if other than the registrant within 15 days after discovery of the misadministration.

C. Records of misadministrations. A registrant shall retain a record of misadministrations reported in accordance with subsection B of this section for three years. The record shall contain the following:

1. The registrant's name and the names of the individuals involved;

2. The social security number or other identification number, if one has been assigned, of the individual who is the subject of the misadministration;

3. A brief description of the event; why it occurred; and the effect, if any, on the individual;

4. The actions, if any, taken or planned to prevent recurrence; and

5. Whether the registrant notified the individual, or the individual's responsible relative or guardian and, if not, whether such failure to notify was based on guidance from the referring physician.

History

• Statutory Authority: §§ 32.1-12 and 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 32, Issue 17, eff. June 5, 2016.

12VAC5-481-3420 Therapeutic radiation machines of less than 500 kV

A. Leakage radiation. When the x-ray tube is operated at its maximum rated tube current for the maximum kV, the leakage air kerma rate shall not exceed the value specified at the distance specified for that classification of therapeutic radiation machine:

1. 5‑50 kV systems. The leakage air kerma rate measured at any position five centimeters from the tube housing assembly shall not exceed one mGy (100 mrad) in any one hour.

2. Greater than 50 and less than 500 kV systems. The leakage air kerma rate measured at a distance of one meter from the target in any direction shall not exceed one cGy (1 rad) in any one hour. This air kerma rate measurement may be averaged over areas no larger than 100 square centimeters. In addition, the air kerma rate at a distance of five centimeters from the surface of the tube housing assembly shall not exceed 30 cGy (30 rad) per hour.

3. For each therapeutic radiation machine, the registrant shall determine, or obtain from the manufacturer, the leakage radiation existing at the positions specified in subdivisions 1 and 2 of this subsection for the specified operating conditions. Records on leakage radiation measurements shall be maintained at the installation for inspection by the agency.

B. Permanent beam limiting devices. Permanent diaphragms or cones used for limiting the useful beam shall provide at least the same degree of attenuation as required for the tube housing assembly.

C. Adjustable or removable beam limiting devices.

1. All adjustable or removable beam limiting devices, diaphragms, cones or blocks shall not transmit more than 5.0% of the useful beam for the most penetrating beam used;

2. When adjustable beam limiting devices are used, the position and shape of the radiation field shall be indicated by a light beam.

D. Filter system. The filter system shall be so designed that:

1. Filters cannot be accidentally displaced at any possible tube orientation;

2. For equipment installed after September 20, 2006, an interlock system prevents irradiation if the proper filter is not in place;

3. The air kerma rate escaping from the filter slot shall not exceed one cGy (1 rad) per hour at one meter under any operating conditions; and

4. Each filter shall be marked as to its material of construction and its thickness.

E. Tube immobilization.

1. The x-ray tube shall be so mounted that it cannot accidentally turn or slide with respect to the housing aperture; and

2. The tube housing assembly shall be capable of being immobilized for stationary portal treatments.

F. Source marking. The tube housing assembly shall be so marked that it is possible to determine the location of the source to within five millimeters, and such marking shall be readily accessible for use during calibration procedures.

G. Beam block. Contact therapy tube housing assemblies shall have a removable shield of material, equivalent in attenuation to 0.5 millimeters of lead at 100 kV, which can be positioned over the entire useful beam exit port during periods when the beam is not in use.

H. Timer. A suitable irradiation control device shall be provided to terminate the irradiation after a pre-set time interval.

1. A timer with a display shall be provided at the treatment control panel. The timer shall have a pre-set time selector and an elapsed time or time remaining indicator;

2. The timer shall be a cumulative timer that activates with an indication of "BEAM-ON" and retains its reading after irradiation is interrupted or terminated. After irradiation is terminated and before irradiation can be reinitiated, it shall be necessary to reset the elapsed time indicator;

3. The timer shall terminate irradiation when a preselected time has elapsed, if any dose monitoring system present has not previously terminated irradiation;

4. The timer shall permit accurate pre-setting and determination of exposure times as short as one second;

5. The timer shall not permit an exposure if set at zero;

6. The timer shall not activate until the shutter is opened when irradiation is controlled by a shutter mechanism unless calibration includes a timer error correction to compensate for mechanical lag; and

7. The timer shall be accurate to within 1.0% of the selected value or one second, whichever is greater.

I. Control panel functions. The control panel, in addition to the displays required by other provisions in this section, shall have:

1. An indication of whether electrical power is available at the control panel and if activation of the x-ray tube is possible;

2. An indication of whether x-rays are being produced;

3. A means for indicating x-ray tube potential and current;

4. The means for terminating an exposure at any time;

5. A locking device which will prevent unauthorized use of the therapeutic radiation machine; and

6. For therapeutic radiation machines manufactured after September 20, 2006, a positive display of specific filters in the beam.

J. Multiple tubes. When a control panel may energize more than one x-ray tube:

1. It shall be possible to activate only one x-ray tube at any time;

2. There shall be an indication at the control panel identifying which x-ray tube is activated; and

3. There shall be an indication at the tube housing assembly when that tube is energized.

K. Target-to-skin distance (TSD). There shall be a means of determining the central axis TSD to within one centimeter and of reproducing this measurement to within two millimeters thereafter.

L. Shutters. Unless it is possible to bring the x-ray output to the prescribed exposure parameters within five seconds after the x-ray "ON" switch is energized, the beam shall be attenuated by a shutter having a lead equivalency not less than that of the tube housing assembly. In addition, after the unit is at operating parameters, the shutter shall be controlled by the operator from the control panel. An indication of shutter position shall appear at the control panel.

M. Low filtration x-ray tubes. Each therapeutic radiation machine equipped with a beryllium or other low-filtration window shall be clearly labeled as such upon the tube housing assembly and shall be provided with a permanent warning device on the control panel that is activated when no additional filtration is present, to indicate that the dose rate is very high.

N. Facility design requirements for therapeutic radiation machines capable of operating in the range 50 kV to 500 kV. In addition to adequate shielding to meet requirements of 12VAC5-481-3450, the treatment room shall meet the following design requirements:

1. Aural communication. Provision shall be made for continuous two-way aural communication between the patient and the operator at the control panel;

2. Viewing systems. Provision shall be made to permit continuous observation of the patient during irradiation and the viewing system shall be so located that the operator can observe the patient from the control panel. The therapeutic radiation machine shall not be used for patient irradiation unless at least one viewing system is operational.

O. Additional requirements. Treatment rooms that contain a therapeutic radiation machine capable of operating above 150 kV shall meet the following additional requirements:

1. All protective barriers shall be fixed except for entrance doors or beam interceptors;

2. The control panel shall be located outside the treatment room or in a totally enclosed booth, which has a ceiling, inside the room;

3. Interlocks shall be provided such that all entrance doors, including doors to any interior booths, shall be closed before treatment can be initiated or continued. If the radiation beam is interrupted by any door opening, it shall not be possible to restore the machine to operation without closing the door and reinitiating irradiation by manual action at the control panel; and

4. When any door referred to in subdivision 3 of this subsection is opened while the x-ray tube is activated, the air kerma rate at a distance of one meter from the source shall be reduced to less than one mGy (100 mrad) per hour.

P. Full calibration measurements.

1. Full calibration of a therapeutic radiation machine subject to this section shall be performed by, or under the direct supervision of, a qualified medical physicist:

a. Before the first medical use following installation or reinstallation of the therapeutic radiation machine;

b. At intervals not exceeding one year; and

c. Before medical use under the following conditions:

(1) Whenever quality assurance check measurements indicate that the radiation output differs by more than 5.0% from the value obtained at the last full calibration and the difference cannot be reconciled; and

(2) Following any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam.

d. Notwithstanding the requirements of subdivision 1 c of this subsection:

(1) Full calibration of therapeutic radiation machines with multienergy capabilities is required only for those modes or energies that are not within their acceptable range; and

(2) If the repair, replacement or modification does not affect all energies, full calibration shall be performed on the affected energy that is in most frequent clinical use at the facility. The remaining energies may be validated with quality assurance check procedures against the criteria in subdivision 1 c (1) of this subsection.

2. To satisfy the requirement of subdivision 1 of this subsection, full calibration shall include all measurements recommended for annual calibration by the National Council on Radiation Protection and Measurements (NCRP) Report 69, "Dosimetry of X-ray and Gamma Ray Beams for Radiation Therapy in the Energy Range 10 keV to 50 MeV" (1981).

3. The registrant shall maintain a record of each calibration for the duration of the registration. The record shall include: the date of the calibration; the manufacturer's name, model number, and serial number for both the therapeutic radiation machine and the x-ray tube; the model numbers and serial numbers of the instruments used to calibrate the therapeutic radiation machine; and the signature of the qualified medical physicist responsible for performing the calibration.

Q. Periodic quality assurance checks.

1. Periodic quality assurance checks shall be performed on therapeutic radiation machines subject to this section, which are capable of operation at greater than or equal to 50 kV;

2. To satisfy the requirement of subdivision 1 of this subsection, quality assurance checks shall meet the following requirements:

a. The registrant shall perform quality assurance checks in accordance with written procedures established by the qualified medical physicist; and

b. The quality assurance check procedures shall specify the frequency at which tests or measurements are to be performed. The quality assurance check procedures shall specify that the quality assurance check shall be performed during the calibration specified in subdivision P 1 of this section. The acceptable tolerance for each parameter measured in the quality assurance check, when compared to the value for that parameter determined in the calibration specified in subdivision P 1 of this section, shall be stated;

3. The cause for a parameter exceeding a tolerance set by the qualified medical physicist shall be investigated and corrected before the system is used for patient irradiation;

4. Whenever a quality assurance check indicates a significant change in the operating characteristics of a system, as specified in the qualified medical physicist's quality assurance check procedures, the system shall be recalibrated as required in subdivision P 1 of this section;

5. The registrant shall use the dosimetry system described in 12VAC5-481-3400 C 2 to make the quality assurance check required in subdivision 2 of this subsection;

6. The registrant shall have the qualified medical physicist review and sign the results of each radiation output quality assurance check within 30 days of the date that the check was performed;

7. The registrant shall ensure that safety quality assurance checks of therapeutic radiation machines subject to this section are performed at intervals not to exceed 30 days;

8. Notwithstanding the requirements of subdivisions 4 and 7 of this subsection, the registrant shall ensure that no therapeutic radiation machine is used to administer radiation to humans unless the quality assurance checks required by subdivisions 4 and 7 of this subsection have been performed within the 30-day period immediately prior to said administration;

9. To satisfy the requirement of subdivision 7 of this subsection, safety quality assurance checks shall ensure proper operation of:

a. Electrical interlocks at each external beam radiation therapy room entrance;

b. The "BEAM-ON" and termination switches;

c. Beam condition indicator lights on the access door, control console, and in the radiation therapy room;

d. Viewing systems; and

e. If applicable, electrically operated treatment room doors from inside and outside the treatment room; and

10. The registrant shall maintain a record of each quality assurance check required by subdivisions 1 and 7 of this subsection for three years. The record shall include the date of the quality assurance check; the manufacturer's name, the model number, and serial number of the therapeutic radiation machine; the manufacturer's name, the model number, and serial number for the instruments used to measure the radiation output of the therapeutic radiation machine; and the signature of the individual who performed the periodic quality assurance check.

R. Operating procedures.

1. The therapeutic radiation machine shall not be used for irradiation of patients unless the requirements of subsections P and Q of this section have been met;

2. Therapeutic radiation machines shall not be left unattended unless secured pursuant to subdivision I 5 of this section;

3. When a patient must be held in position for radiation therapy, mechanical supporting or restraining devices shall be used;

4. The tube housing assembly shall not be held by an individual during operation unless the assembly is designed to require such holding and the peak tube potential of the system does not exceed 50 kV. In such cases, the holder shall wear protective gloves and an apron of not less than 0.5 millimeters lead equivalency at 100 kV;

5. A copy of the current operating and emergency procedures shall be maintained at the therapeutic radiation machine control console; and

6. No individual other than the patient shall be in the treatment room during exposures from therapeutic radiation machines operating above 150 kV. At energies less than or equal to 150 kV, any individual, other than the patient, in the treatment room shall be protected by a barrier sufficient to meet the requirements of 12VAC5-481-640.

S. Possession of survey instruments. Each facility location authorized to use a therapeutic radiation machine in accordance with this section shall possess appropriately calibrated portable monitoring equipment. As a minimum, such equipment shall include a portable radiation measurement survey instrument capable of measuring dose rates over the range 10 µSv (1 mrem) per hour to 10 mSv (1000 mrem) per hour. The survey instruments shall be operable and calibrated in accordance with 12VAC5-481-3440.

T. Electronic brachytherapy devices are subject to the requirements of 12VAC5-481-3452 and are exempt from the requirements of this section.

History

• Statutory Authority: §§ 32.1-12 and 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 32, Issue 17, eff. June 5, 2016.

12VAC5-481-3430 Therapeutic radiation machines - photon therapy systems (500 kV and above) and electron therapy systems (500 kV and above)

A. Possession of survey instruments. Each facility location authorized to use a therapeutic radiation machine in accordance with this section shall have access to appropriately calibrated portable monitoring equipment. As a minimum, such equipment shall include a portable radiation measurement survey instrument capable of measuring dose rates over the range 10 µSv (1 mrem) per hour to 10 mSv (1000 mrem) per hour. The survey instruments shall be operable and calibrated in accordance with 12VAC5-481-3440.

B. Leakage radiation outside the maximum useful beam in photon and electron modes.

1. The absorbed dose due to leakage radiation (excluding neutrons) at any point outside the maximum sized useful beam, but within a circular plane of radius two meters which is perpendicular to and centered on the central axis of the useful beam at the nominal treatment distance (i.e., patient plane), shall not exceed a maximum of 0.2% and an average of 0.1% of the absorbed dose on the central axis of the beam at the nominal treatment distance. Measurements shall be averaged over an area not exceeding 100 square centimeters at a minimum of 16 points uniformly distributed in the plane;

2. Except for the area defined in subdivision 1 of this subsection, the absorbed dose due to leakage radiation (excluding neutrons) at one meter from the electron path between the electron source and the target or electron window shall not exceed 0.5% of the absorbed dose on the central axis of the beam at the nominal treatment distance. Measurements shall be averaged over an area not exceeding 100 square centimeters;

3. For equipment manufactured after September 20, 2006, the neutron absorbed dose outside the useful beam shall be in compliance with International Electrotechnical Commission (IEC) Document 601-2-1 (most current revision); and

4. For each therapeutic radiation machine, the registrant shall determine, or obtain from the manufacturer, the leakage radiation existing at the positions specified in subdivisions 1, 2, and 3 of this subsection for the specified operating conditions. Records on leakage radiation measurements shall be maintained at the installation for inspection by the agency.

C. Leakage radiation through beam limiting devices.

1. Photon radiation. All adjustable or interchangeable beam limiting devices shall attenuate the useful beam such that at the nominal treatment distance, the maximum absorbed dose anywhere in the area shielded by the beam limiting devices shall not exceed 2.0% of the maximum absorbed dose on the central axis of the useful beam measured in a 100 square centimeter radiation field, or maximum available field size if less than 100 square centimeters;

2. Electron radiation. All adjustable or interchangeable electron applicators shall attenuate the radiation, including but not limited to photon radiation generated by electrons incident on the beam limiting device and electron applicator and other parts of the radiation head, such that the absorbed dose in a plane perpendicular to the central axis of the useful beam at the nominal treatment distance shall not exceed:

a. A maximum of 2.0% and average of 0.5% of the absorbed dose on the central axis of the useful beam at the nominal treatment distance. This limit shall apply beyond a line seven centimeters outside the periphery of the useful beam; and

b. A maximum of 10% of the absorbed dose on the central axis of the useful beam at the nominal treatment distance. This limit shall apply beyond a line two centimeters outside the periphery of the useful beam.

3. Measurement of leakage radiation.

a. Photon radiation. Measurements of leakage radiation through the beam limiting devices shall be made with the beam limiting devices closed and any residual aperture blocked by at least two tenth-value layers of suitable absorbing material. In the case of overlapping beam limiting devices, the leakage radiation through each set shall be measured independently at the depth of maximum dose. Measurements shall be made using a radiation detector of area not exceeding 10 square centimeters;

b. Electron radiation. Measurements of leakage radiation through the electron applicators shall be made with the electron beam directed into the air and using a radiation detector of area up to but not exceeding one square centimeter suitably protected against radiation which has been scattered from material beyond the radiation detector. Measurements shall be made using one centimeter of water equivalent build up material.

D. Filters and wedges.

1. Each wedge filter that is removable from the system shall be clearly marked with an identification number. For removable wedge filters, the nominal wedge angle shall appear on the wedge or wedge tray (if permanently mounted to the tray). If the wedge or wedge tray is significantly damaged, the wedge transmission factor shall be redetermined.

2. If the absorbed dose rate information required by subsection I of this section relates exclusively to operation with a field flattening filter or beam scattering foil in place, such foil or filter shall be removable only by the use of tools.

3. For equipment manufactured after September 20, 2006, that utilizes wedge filters, interchangeable field flattening filters, or interchangeable beam scattering foils:

a. Irradiation shall not be possible until a selection of a filter or a positive selection to use "no filter" has been made at the treatment control panel, either manually or automatically;

b. An interlock system shall be provided to prevent irradiation if the filter selected is not in the correct position;

c. A display shall be provided at the treatment control panel showing the wedge filters, interchangeable field flattening filters, or interchangeable beam scattering foils in use; and

d. An interlock shall be provided to prevent irradiation if any filter or beam scattering foil selection operation carried out in the treatment room does not agree with the filter or beam scattering foil selection operation carried out at the treatment control panel.

E. Stray radiation in the useful beam. For equipment manufactured after September 20, 2006, the registrant shall determine during acceptance testing, or obtain from the manufacturer, data sufficient to ensure that x-ray stray radiation in the useful electron beam, absorbed dose at the surface during x-ray irradiation, and stray neutron radiation in the useful x-ray beam are in compliance with International Electrotechnical Commission (IEC) Document 601-2-1 (most current revision).

F. Beam monitors. All therapeutic radiation machines subject to this section shall be provided with redundant beam monitoring systems. The sensors for these systems shall be fixed in the useful beam during treatment to indicate the dose monitor unit rate.

1. Equipment manufactured after September 20, 2006, shall be provided with at least two independently powered integrating dose meters. Alternatively, common elements may be used if the production of radiation is terminated upon failure of any common element.

2. Equipment manufactured on or before September 20, 2006, shall be provided with at least one radiation detector. This detector shall be incorporated into a useful beam monitoring system.

3. The detector and the system into which that detector is incorporated shall meet the following requirements:

a. Each detector shall be removable only with tools and, if movable, shall be interlocked to prevent incorrect positioning.

b. Each detector shall form part of a beam monitoring system from whose readings in dose monitor units the absorbed dose at a reference point can be calculated.

c. Each beam monitoring system shall be capable of independently monitoring, interrupting, and terminating irradiation.

d. For equipment manufactured after September 20, 2006, the design of the beam monitoring systems shall ensure that the:

(1) Malfunctioning of one system shall not affect the correct functioning of the other systems; and

(2) Failure of either system shall terminate irradiation or prevent the initiation of radiation.

e. Each beam monitoring system shall have a legible display at the treatment control panel. For equipment manufactured after September 20, 2006, each display shall:

(1) Maintain a reading until intentionally reset;

(2) Have only one scale and no electrical or mechanical scale multiplying factors;

(3) Utilize a design such that increasing dose is displayed by increasing numbers; and

(4) In the event of power failure, the beam monitoring information required in subdivision 3 e (3) of this subsection displayed at the control panel at the time of failure shall be retrievable in at least one system for a 20-minute period of time.

G. Beam symmetry.

1. A bent-beam linear accelerator with beam flattening filter subject to this section shall be provided with an auxiliary device to monitor beam symmetry;

2. The device referenced in subdivision 1 of this subsection shall be able to detect field asymmetry greater than 10%; and

3. The device referenced in subdivision 1 of this subsection shall be configured to terminate irradiation if the specifications in subdivision 2 of this subsection cannot be maintained.

H. Selection and display of dose monitor units.

1. Irradiation shall not be possible until a new selection of a number of dose monitor units has been made at the treatment control panel;

2. The preselected number of dose monitor units shall be displayed at the treatment control panel until reset manually for the next irradiation;

3. After termination of irradiation, it shall be necessary to reset the dosimeter display before subsequent treatment can be initiated; and

4. For equipment manufactured after September 20, 2006, after termination of irradiation, it shall be necessary for the operator to reset the preselected dose monitor units before irradiation can be initiated.

I. Air kerma rate or absorbed dose rate. For equipment manufactured after September 20, 2006, a system shall be provided from whose readings the air kerma rate or absorbed dose rate at a reference point can be calculated. (The radiation detectors specified in subsection F of this section may form part of this system.) In addition:

1. The dose monitor unit rate shall be displayed at the treatment control panel;

2. If the equipment can deliver under any conditions an air kerma rate or absorbed dose rate at the nominal treatment distance more than twice the maximum value specified by the manufacturer, a device shall be provided that terminates irradiation when the air kerma rate or absorbed dose rate exceeds a value twice the specified maximum. The dose rate at which the irradiation will be terminated shall be a record maintained by the registrant;

3. If the equipment can deliver under any fault conditions an air kerma rate or absorbed dose rate at the nominal treatment distance more than 10 times the maximum value specified by the manufacturer, a device shall be provided to prevent the air kerma rate or absorbed dose rate anywhere in the radiation field from exceeding twice the specified maximum value and to terminate irradiation if the excess absorbed dose at the nominal treatment distance exceeds 4 Gy (400 rad); and

4. For each therapeutic radiation machine, the registrant shall determine, or obtain from the manufacturer, the maximum values specified in subdivisions 2 and 3 of this subsection for the specified operating conditions. Records of these maximum values shall be maintained at the installation for inspection by the agency.

J. Termination of irradiation by the beam monitoring system or systems during stationary beam radiation therapy.

1. Each primary system shall terminate irradiation when the preselected number of dose monitor units has been detected by the system;

2. If the original design of the equipment included a secondary dose monitoring system, that system shall be capable of terminating irradiation when not more than 15% or 40 dose monitor units above the preselected number of dose monitor units set at the control panel has been detected by the secondary dose monitoring system; and

3. For equipment manufactured after September 20, 2006, an indicator on the control panel shall show which monitoring system has terminated irradiation.

K. Termination of irradiation. It shall be possible to terminate irradiation and equipment movement or go from an interruption condition to termination condition at any time from the operator's position at the treatment control panel.

L. Interruption of irradiation. If a therapeutic radiation machine has an interrupt mode, it shall be possible to interrupt irradiation and equipment movements at any time from the treatment control panel. Following an interruption it shall be possible to restart irradiation by operator action without any reselection of operating conditions. If any change is made of a preselected value during an interruption, irradiation and equipment movements shall be automatically terminated.

M. Timer. A suitable irradiation control device shall be provided to terminate the irradiation after a pre-set time interval.

1. A timer shall be provided which has a display at the treatment control panel. The timer shall have a pre-set time selector and an elapsed time indicator;

2. The timer shall be a cumulative timer that activates with an indication of "BEAM-ON" and retains its reading after irradiation is interrupted or terminated. After irradiation is terminated and before irradiation can be reinitiated, it shall be necessary to reset the elapsed time indicator;

3. The timer shall terminate irradiation when a preselected time has elapsed if the dose monitoring systems have not previously terminated irradiation.

N. Selection of radiation type. Equipment capable of both x-ray therapy and electron therapy shall meet the following additional requirements:

1. Irradiation shall not be possible until a selection of radiation type (x-rays or electrons) has been made at the treatment control panel;

2. The radiation type selected shall be displayed at the treatment control panel before and during irradiation;

3. An interlock system shall be provided to ensure that the equipment can principally emit only the radiation type that has been selected;

4. An interlock system shall be provided to prevent irradiation with x-rays, except to obtain an image, when electron applicators are fitted;

5. An interlock system shall be provided to prevent irradiation with electrons when accessories specific for x-ray therapy are fitted; and

6. An interlock system shall be provided to prevent irradiation if any selected operations carried out in the treatment room do not agree with the selected operations carried out at the treatment control panel.

O. Selection of energy. Equipment capable of generating radiation beams of different energies shall meet the following requirements:

1. Irradiation shall not be possible until a selection of energy has been made at the treatment control panel;

2. The nominal energy value selected shall be displayed at the treatment control panel until reset manually for the next irradiation. After termination of irradiation, it shall be necessary to reset the nominal energy value selected before subsequent treatment can be initiated;

3. Irradiation shall not be possible until the appropriate flattening filter or scattering foil for the selected energy is in its proper location; and

4. For equipment manufactured after September 20, 2006, the selection of energy shall be in compliance with International Electrotechnical Commission (IEC) Document 601-2-1.

P. Selection of stationary beam radiation therapy or moving beam radiation therapy. Therapeutic radiation machines capable of both stationary beam radiation therapy and moving beam radiation therapy shall meet the following requirements:

1. Irradiation shall not be possible until a selection of stationary beam radiation therapy or moving beam radiation therapy has been made at the treatment control panel;

2. The mode of operation shall be displayed at the treatment control panel;

3. An interlock system shall be provided to ensure that the equipment can operate only in the mode that has been selected;

4. An interlock system shall be provided to prevent irradiation if any selected parameter in the treatment room does not agree with the selected parameter at the treatment control panel;

5. Moving beam radiation therapy shall be controlled to obtain the selected relationships between incremental dose monitor units and incremental movement. For equipment manufactured after September 20, 2006:

a. An interlock system shall be provided to terminate irradiation if the number of dose monitor units delivered in any 10 degrees of rotation or one centimeter of linear motion differs by more than 20% from the selected value;

b. Where angle terminates the irradiation in moving beam radiation therapy, the dose monitor units delivered shall differ by less than 5.0% from the dose monitor unit value selected;

c. An interlock shall be provided to prevent motion of more than five degrees or one centimeter beyond the selected limits during moving beam radiation therapy;

d. An interlock shall be provided to require that a selection of direction be made at the treatment control panel in all units that are capable of both clockwise and counter-clockwise moving beam radiation therapy;

e. Moving beam radiation therapy shall be controlled with both primary position sensors and secondary position sensors to obtain the selected relationships between incremental dose monitor units and incremental movement;

6. Where the beam monitor system terminates the irradiation in moving beam radiation therapy, the termination of irradiation shall be as required by subsection J of this section; and

7. For equipment manufactured after September 20, 2006, an interlock system shall be provided to terminate irradiation if movement:

a. Occurs during stationary beam radiation therapy; or

b. Does not start or stops during moving beam radiation therapy unless such stoppage is a pre-planned function.

Q. Facility design requirements for therapeutic radiation machines operating above 500 kV. In addition to shielding adequate to meet requirements of 12VAC5-481-3450, the following design requirements are made:

1. Protective barriers. All protective barriers shall be fixed, except for access doors to the treatment room or movable beam interceptors;

2. Control panel. In addition to other requirements specified in Part XV (12VAC5-481-3380 et seq.) of this chapter, the control panel shall also:

a. Be located outside the treatment room;

b. Provide an indication of whether electrical power is available at the control panel and if activation of the radiation is possible;

c. Provide an indication of whether radiation is being produced; and

d. Include an access control (locking) device that will prevent unauthorized use of the therapeutic radiation machine;

3. Viewing systems. Windows, mirrors, closed-circuit television or an equivalent viewing system shall be provided to permit continuous observation of the patient following positioning and during irradiation and shall be so located that the operator may observe the patient from the treatment control panel. The therapeutic radiation machine shall not be used for patient irradiation unless at least one viewing system is operational;

4. Aural communications. Provision shall be made for continuous two-way aural communication between the patient and the operator at the control panel. The therapeutic radiation machine shall not be used for irradiation of patients unless continuous two-way aural communication is possible;

5. Room entrances. Treatment room entrances shall be provided with warning lights in a readily observable position near the outside of all access doors, which will indicate when the useful beam is "ON" and when it is "OFF";

6. Entrance interlocks. Interlocks shall be provided such that all access controls are activated before treatment can be initiated or continued. If the radiation beam is interrupted by any access control, it shall not be possible to restore the machine to operation without resetting the access control and reinitiating irradiation by manual action at the control panel;

7. Beam interceptor interlocks. If the shielding material in any protective barrier requires the presence of a beam interceptor to ensure compliance with 12VAC5-481-720, interlocks shall be provided to prevent the production of radiation, unless the beam interceptor is in place, whenever the useful beam is directed at the designated barrier;

8. Emergency cutoff switches. At least one emergency power cutoff switch shall be located in the radiation therapy room and shall terminate all equipment electrical power including radiation and mechanical motion. This switch is in addition to the termination switch required by subsection K of this section. All emergency power cutoff switches shall include a manual reset so that the therapeutic radiation machine cannot be restarted from the unit's control console without resetting the emergency cutoff switch;

9. Safety interlocks. All safety interlocks shall be designed so that any defect or component failure in the safety interlock system prevents or terminates operation of the therapeutic radiation machine; and

10. Surveys for residual radiation. Surveys for residual activity shall be conducted on all therapeutic radiation machines capable of generating photon and electron energies above 10 MV prior to machining, removing, or working on therapeutic radiation machine components which may have become activated due to photo-neutron production.

R. Qualified medical physicist support.

1. The services of a qualified medical physicist shall be required in facilities having therapeutic radiation machines with energies of 500 kV and above. The qualified medical physicist shall be responsible for:

a. Full calibrations required by subsection T of this section and protection surveys required by 12VAC5-481-3400 A;

b. Supervision and review of dosimetry;

c. Beam data acquisition and transfer for computerized dosimetry, and supervision of its use;

d. Quality assurance, including quality assurance check review required by subdivision U 5 of this section;

e. Consultation with the authorized user in treatment planning, as needed; and

f. Performance of calculations or assessments regarding misadministrations.

2. If the qualified medical physicist is not a full-time employee of the registrant, the operating procedures required by subsection S of this section shall also specifically address how the qualified medical physicist is to be contacted for problems or emergencies, as well as the specific actions, if any, to be taken until the qualified medical physicist can be contacted.

S. Operating procedures.

1. No individual, other than the patient, shall be in the treatment room during treatment or during any irradiation for testing or calibration purposes;

2. Therapeutic radiation machines shall not be made available for medical use unless the requirements of 12VAC5-481-3400 A, and subsections T and U of this section have been met;

3. Therapeutic radiation machines, when not in operation, shall be secured to prevent unauthorized use;

4. When adjustable beam limiting devices are used, the position and shape of the radiation field shall be indicated by a light field;

5. If a patient must be held in position during treatment, mechanical supporting or restraining devices shall be used; and

6. A copy of the current operating and emergency procedures shall be maintained at the therapeutic radiation machine control console.

T. Acceptance testing, commissioning, and full calibration measurements.

1. Acceptance testing, commissioning and full calibration of a therapeutic radiation machine subject to this section shall be performed by, or under the direct supervision of, a qualified medical physicist.

2. Acceptance testing and commissioning shall be performed in accordance with the American Association of Physicists in Medicine (AAPM) AAPM Code of Practice for Radiotherapy Accelerators: AAPM Report Number 47," prepared by Radiation Therapy Task Group 45 and the manufacturer's contractual specifications. Acceptance testing and commissioning shall be conducted before the first medical use following installation or reinstallation of the therapeutic radiation machine.

3. Full calibration shall include measurement of all parameters required by Table II of "Comprehensive QA for Radiation Oncology: Report of AAPM Radiation Therapy: AAPM Report No. 46," prepared by Committee Task Group 40 and shall be performed in accordance with "AAPM Code of Practice for Radiotherapy Accelerators: AAPM Report No. 47" prepared by Radiation Therapy Task Group 45. Although it shall not be necessary to complete all elements of a full calibration at the same time, all parameters (for all energies) shall be completed at intervals not exceeding 12 calendar months, unless a more frequent interval is required in Table II.

4. The qualified medical physicist shall perform all elements of a full calibration necessary to determine that all parameters are within acceptable limits:

a. Whenever quality assurance check measurements indicate that the radiation output differs by more than 5.0% from the value obtained at the last full calibration and the difference cannot be reconciled. Therapeutic radiation machines with multienergy or multimode capabilities shall only require measurements for those modes or energies that are not within their acceptable range; and

b. Following any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam. If the repair, replacement or modification does not affect all modes or energies, measurements shall be performed on the effected mode or energy that is in most frequent clinical use at the facility. The remaining energies or modes may be validated with quality assurance check procedures against the criteria in subdivision 4 a of this subsection.

5. The registrant shall maintain a record of each calibration in an auditable form for the duration of the registration. The record shall include the date of the calibration; the manufacturer's name, model number, and serial number for the therapeutic radiation machine; the model numbers and serial numbers of the instruments used to calibrate the therapeutic radiation machine; and the signature of the qualified medical physicist responsible for performing the calibration.

U. Periodic quality assurance checks.

1. Periodic quality assurance checks shall be performed on all therapeutic radiation machines subject to this section at intervals not to exceed those specified in "Comprehensive QA for Radiation Oncology: AAPM Report No. 46," prepared by AAPM Radiation Therapy Committee Task Group 40;

2. To satisfy the requirement of subdivision 1 of this subsection, quality assurance checks shall include determination of central axis radiation output and a representative sampling of periodic quality assurance checks contained in "Comprehensive QA for Radiation Oncology: AAPM Report No. 46" prepared by AAPM Radiation Therapy Committee Task Group 40. Representative sampling shall include all referenced periodic quality assurance checks in an interval not to exceed 12 consecutive calendar months;

3. The registrant shall use a dosimetry system that has been inter-compared within the previous 12 months with the dosimetry system described in 12VAC5-481-3400 C 1 to make the periodic quality assurance checks required in subdivision 2 of this subsection;

4. The registrant shall perform periodic quality assurance checks required by subdivision 1 of this subsection in accordance with procedures established by the qualified medical physicist;

5. The registrant shall review the results of each periodic radiation output check according to the following procedures:

a. The authorized user and qualified medical physicist shall be immediately notified if any parameter is not within its acceptable tolerance. The therapeutic radiation machine shall not be made available for subsequent medical use until the qualified medical physicist has determined that all parameters are within their acceptable tolerances;

b. If all quality assurance check parameters appear to be within their acceptable ranges, the quality assurance check shall be reviewed and signed by either the authorized user or qualified medical physicist within three treatment days; and

c. The qualified medical physicist shall review and sign the results of each radiation output quality assurance check at intervals not to exceed 30 days.

6. Therapeutic radiation machines subject to this section shall have applicable safety quality assurance checks listed in "Comprehensive QA for Radiation Oncology: AAPM Report No. 46," prepared by AAPM Radiation Therapy Committee Task Group 40 performed at intervals not to exceed one week;

7. To satisfy the requirement of subdivision 6 of this subsection, safety quality assurance checks shall ensure proper operation of:

a. Electrical interlocks at each external beam radiation therapy room entrance;

b. Proper operation of the "BEAM-ON," interrupt, and termination switches;

c. Beam condition indicator lights on the access doors, control console, and in the radiation therapy room;

d. Viewing systems;

e. Electrically operated treatment room doors from inside and outside the treatment room;

f. At least one emergency power cutoff switch. If more than one emergency power cutoff switch is installed and not all switches are tested at once, each switch shall be tested on a rotating basis. Safety quality assurance checks of the emergency power cutoff switches may be conducted at the end of the treatment day in order to minimize possible stability problems with the therapeutic radiation machine.

8. The registrant shall promptly repair any system identified in subdivision 7 of this subsection that is not operating properly; and

9. The registrant shall maintain a record of each quality assurance check required by subdivisions 1 and 7 of this subsection for three years. The record shall include: the date of the quality assurance check; the manufacturer's name, model number, and serial number of the therapeutic radiation machine; the manufacturer's name, model number and serial number for the instruments used to measure the radiation output of the therapeutic radiation machine; and the signature of the individual who performed the periodic quality assurance check.

V. Quality assurance checks for intensity modulated radiation therapy (IMRT) shall:

1. Include commissioning and testing of the treatment planning and delivery systems, routine quality assurance of the delivery system, and patient-specific validation of treatment plans;

2. Be performed in accordance with "Guidance document on delivery, treatment planning, and clinical implementation of IMRT: Report of the IMRT subcommittee of the AAPM radiation therapy committee: AAPM Report No. 82"; and

3. Be performed in accordance with the manufacturer's contractual specifications.

History

• Statutory Authority: §§ 32.1-12 and 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 17, eff. June 5, 2016.

12VAC5-481-3440 Calibration of survey instruments

A. The registrant shall ensure that the survey instruments used to show compliance with Part XV (12VAC5-481-3380 et seq.) of this chapter have been calibrated before first use, at intervals not to exceed 12 months, and following repair.

B. To satisfy the requirements of subsection A of this section, the registrant shall:

1. Calibrate all required scale readings up to 10 mSv (1000 mrem) per hour with an appropriate radiation source that is traceable to the National Institute of Standards and Technology (NIST);

2. Calibrate at least two (2) points on each scale to be calibrated. These points should be at approximately 1/3 and 2/3 of full-scale; and

C. To satisfy the requirements of subsection B of this section, the registrant shall:

1. Consider a point as calibrated if the indicated dose rate differs from the calculated dose rate by not more than 10%; and

2. Consider a point as calibrated if the indicated dose rate differs from the calculated dose rate by not more than 20% if a correction factor or graph is conspicuously attached to the instrument.

D. The registrant shall retain a record of each calibration required in subsection A of this section for three years. The record shall include:

1. A description of the calibration procedure; and

2. A description of the source used and the certified dose rates from the source, and the rates indicated by the instrument being calibrated, the correction factors deduced from the calibration data, the signature of the individual who performed the calibration, and the date of calibration.

E. The registrant may obtain the services of individuals licensed by the agency, the NRC, or another agreement state to perform calibrations of survey instruments. Records of calibrations that contain information required by subsection D of this section shall be maintained by the registrant.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3450 Shielding and safety design requirements

A. Each therapeutic radiation machine subject to 12VAC5-481-3420 or 12VAC5-481-3430 shall be provided with such primary or secondary barriers as are necessary to ensure compliance with 12VAC5-481-640 and 12VAC5-481-720.

B. Facility design information for all new installations of a therapeutic radiation machine or installations of a therapeutic radiation machine of higher energy into a room not previously approved for that energy shall be submitted for agency approval prior to actual installation of the therapeutic radiation machine. At a minimum, facility design information shall include:

1. All therapeutic radiation machines.

a. Basic facility information including name, telephone number, and agency registration number of the individual responsible for preparation of the shielding plan; name and telephone number of the facility supervisor; and the street address, including room number, of the therapeutic radiation machine facility. The plan shall also indicate whether this is a new structure or a modification to an existing structure.

b. The primary areas where all wall, floor, and ceiling areas are struck by the useful beam.

c. The secondary barriers where all wall, floor, and ceiling areas do not have primary barriers.

2. Therapeutic radiation machines less than or equal to 150 kV (photons only). In addition to the requirements listed in subdivision 1 of this subsection, therapeutic radiation machine facilities that produce only photons with a maximum energy less than or equal to 150 kV shall submit shielding plans that contain, at a minimum, the following additional information:

a. Equipment specifications, including the manufacturer and model number of the therapeutic radiation machine, as well as the maximum technique factors;

b. Maximum design workload for the facility including total weekly radiation output, expressed in gray (rad) or air kerma at one meter; total beam-on time per day or per week; average treatment time per patient; and the anticipated number of patients to be treated per day or per week;

c. A facility blueprint or drawing indicating scale (0.25 inch equals 1 foot is typical); direction of north; normal location of the therapeutic radiation machine's radiation port; the port's travel and traverse limits; general direction of the useful beam; locations of any windows and doors; and location of the therapeutic radiation machine control panel. If the control panel is located inside the therapeutic radiation machine treatment room, the location of the operator's booth shall be noted on the plan and the operator's station at the control panel shall be behind a protective barrier sufficient to ensure compliance with 12VAC5-481-640;

d. The structural composition and thickness or lead or concrete equivalent of all walls, doors, partitions, floor, and ceiling of the room concerned;

e. The type of occupancy of all adjacent areas inclusive of space above and below the room concerned. If there is an exterior wall, the distance to the closest areas where it is likely that individuals may be present shall be included; and

f. At least one example calculation that shows the methodology used to determine the amount of shielding required for each physical condition (e.g., primary, secondary, and leakage barriers; restricted and unrestricted areas; and entry doors) and shielding material in the facility:

(1) If commercial software is used to generate shielding requirements, the software used and the version and revision date shall be identified.

(2) If the software used to generate shielding requirements is not in the open literature, quality control sample calculations to verify the result obtained with the software shall be submitted.

3. Therapeutic radiation machines over 150 kV. In addition to the requirements listed in subdivision 1 of this subsection, therapeutic radiation machine facilities that produce photons with a maximum energy in excess of 150 kV or electrons, or both, shall submit shielding plans that contain, at a minimum, the following additional information:

a. Equipment specifications including the manufacturer and model number of the therapeutic radiation machine, gray (rad) at the isocenter, and the energy and type of radiation produced (e.g., photon, electron). The target to isocenter distance shall be specified;

b. Maximum design workload for the facility including total weekly radiation output, expressed in gray (rad) at one meter; total beam-on time per day or per week; the average treatment time per patient; and the anticipated number of patients to be treated per day or per week;

c. Facility blueprint or drawing, including both floor plan and elevation views, indicating relative orientation of the therapeutic radiation machine; scale (0.25 inch equals 1 foot is typical); type, thickness, and minimum density of shielding material; direction of north, locations and size of all penetrations through each shielding barrier (ceiling, walls, and floor); and details of the door and maze;

d. The structural composition and thickness or concrete equivalent of walls, doors, partitions, floor, and ceiling of the room concerned;

e. The type of occupancy of all adjacent areas inclusive of space above and below the room concerned. If there is an exterior wall, the distance to the closest areas where it is likely that individuals may be present shall be included;

f. Description of all assumptions that were used in shielding calculations including, but not limited to, design energy (e.g., room may be designed for 6 MV unit although only a 4 MV unit is currently proposed), workload, presence of integral beam-stop in unit, occupancy and use of adjacent areas, fraction of time that useful beam will intercept each permanent barrier (walls, floor, and ceiling), and "allowed" radiation exposure in both restricted and unrestricted areas; and

g. At least one example calculation that shows the methodology used to determine the amount of shielding required for each physical condition (e.g., primary, secondary, and leakage barriers; restricted and unrestricted areas; small angle scatter; entry doors; and maze), and shielding material in the facility.

(1) If commercial software is used to generate shielding requirements, the software used and the version and revision date shall be identified; and

(2) If the software used to generate shielding requirements is not in the open literature, quality control sample calculations to verify the result obtained with the software shall be submitted.

4. Neutron shielding. In addition to the requirements listed in subdivision 3 of this subsection, therapeutic radiation machine facilities that are capable of operating above 10 MV shall submit shielding plans that contain, at a minimum, the following additional information:

a. The structural composition, thickness, minimum density, and location of all neutron shielding material;

b. Description of all assumptions that were used in neutron shielding calculations including, but not limited to, neutron spectra as a function of energy, neutron fluence rate, absorbed dose and dose equivalent (due to neutrons) in both restricted and unrestricted areas;

c. At least one example calculation that shows the methodology used to determine the amount of neutron shielding required for each physical condition (e.g., restricted and unrestricted areas, entry doors, and maze), and neutron shielding material utilized in the facility.

(1) If commercial software is used to generate shielding requirements, the software used and the version and revision date shall be identified; and

(2) If the software used to generate shielding requirements is not in the open literature, control sample calculations to verify the result obtained with the software shall be submitted.

d. The methods and instrumentation that will be used to verify the adequacy of all neutron shielding installed in the facility.

History

• Statutory Authority: §§ 32.1-12 and 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 32, Issue 17, eff. June 5, 2016.

12VAC5-481-3451 Quality assurance for radiation therapy simulation systems

Quality assurance for a conventional or virtual simulator shall include acceptance testing and periodic verification of system performance and shall be performed in accordance with (i) "Comprehensive QA for Radiation Oncology: AAPM Report No. 46, Report of AAPM Radiation Therapy Committee Task Group No.40" for a conventional simulator or (ii) "Quality assurance for computed tomography simulators and the computed tomography-simulation process: AAPM Report No. 83, Report of the AAPM Radiation Therapy Committee Task Group No. 66" for a virtual simulator.

History

• Statutory Authority: §§ 32.1-12 and 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 17, eff. June 5, 2016.

12VAC5-481-3452 Electronic brachytherapy

A. Applicability. Electronic brachytherapy devices shall be subject to the requirements of this section and shall be exempt for the requirements of 12VAC5-481-3420.

1. An electronic brachytherapy device that does not meet the requirements of this section shall not be used for irradiation of patients; and

2. An electronic brachytherapy device shall only be utilized for human use applications specifically approved by the U.S. Food and Drug Administration (FDA) unless participating in a research study approved by the registrant's institutional review board (IRB).

B. Possession of survey instruments. Each facility location authorized to use an electronic brachytherapy device in accordance with this section shall have access to appropriately calibrated portable monitoring equipment. At a minimum, such equipment shall include a portable radiation measurement survey instrument capable of measuring dose rates over the range 10 µSv (1 mrem) per hour to 10 mSv (1000 mrem) per hour. The survey instruments shall be operable and calibrated in accordance with 12VAC5-481-3440 for the applicable electronic brachytherapy source energy.

C. Facility design requirements for electronic brachytherapy devices. In addition to shielding adequate to meet requirements of 12VAC5-481-3450, the treatment room shall meet the following design requirements:

1. If applicable, provision shall be made to prevent simultaneous operation of more than one therapeutic radiation machine in a treatment room.

2. Access to the treatment room shall be controlled by a door at each entrance.

3. Each treatment room shall have provisions to permit continuous aural communication and visual observation of the patient from the treatment control panel during irradiation. The electronic brachytherapy device shall not be used for patient irradiation unless the patient can be observed.

4. For electronic brachytherapy devices capable of operating below 50 kV, radiation shielding for the staff in the treatment room shall be available, either as a portable shield or as localized shielded material around the treatment site.

5. For electronic brachytherapy devices capable of operating at greater than 150 kV:

a. The control panel shall be located outside the treatment room; and

b. Electrical interlocks shall be provided for all doors to the treatment room that will:

(a) Prevent the operator from initiating the treatment cycle unless each treatment room entrance door is closed;

(b) Cause the source to be shielded when an entrance door is opened; and

(c) Prevent the source from being exposed following an interlock interruption until all treatment room entrance doors are closed and the source on-off control is reset at the console.

D. Electrical safety for electronic brachytherapy devices.

1. The high voltage transformer shall be electrically isolated to prevent electrical and magnetic interference with the surrounding environment and ancillary equipment.

2. The high voltage transformer shall be isolated from personnel (e.g., an operator) and the environment by a protective housing that can only be accessed through a cover requiring a tool for access or with electrical interlocks to prevent operation while open.

3. The high voltage transformer shall have appropriate safety labels warning personnel of potential electrical shock or heat related injuries.

4. Equipment manufactured after March 2009 shall be in compliance with the most current revision of the following International Electrotechnical Commission (IEC) Documents:

a. IEC 60601-1:1998+A1+A2:1995;

b. IEC 60601-1-2:2001;

c. IEC 60601-2-8:1999; and

d. IEC 60601-2-17:2004.

E. Control panel functions. The control panel, in addition to the displays required by other provisions in this section, shall:

1. Provide an indication of whether electrical power is available at the control panel and if activation of the electronic brachytherapy source is possible;

2. Provide an indication of whether x-rays are being produced;

3. Provide a means for indicating electronic brachytherapy source potential and current;

4. Provide the means for terminating an exposure at any time; and

5. Include an access control (locking) device that will prevent unauthorized use of the electronic brachytherapy device.

F. Timer. A suitable irradiation control device (timer) shall be provided to terminate the irradiation after a pre-set time interval or integrated charge on a dosimeter-based monitor.

1. A timer shall be provided at the treatment control panel. The timer shall indicate planned setting and the time elapsed or remaining;

2. The timer shall not permit an exposure if set at zero;

3. The timer shall be a cumulative device that activates with an indication of "BEAM-ON" and retains its reading after irradiation is interrupted or terminated. After irradiation is terminated and before irradiation can be reinitiated, it shall be necessary to reset the elapsed time indicator;

4. The timer shall terminate irradiation when a preselected time has elapsed if any dose monitoring system has not previously terminated irradiation;

5. The timer shall permit setting of exposure times as short as 0.1 second; and

6. The timer shall be accurate to within 1.0% of the selected value or 0.1 second, whichever is greater.

G. Qualified medical physicist support.

1. The services of a qualified medical physicist shall be required in facilities having electronic brachytherapy devices. The qualified medical physicist shall be responsible for:

a. Evaluation of the output from the electronic brachytherapy source;

b. Generation of the necessary dosimetric information;

c. Supervision and review of treatment calculations prior to initial treatment of any treatment site;

d. Establishing the periodic and day-of-use quality assurance checks and reviewing the data from those checks as required in subsection K of this section;

e. Consultation with the authorized user in treatment planning, as needed; and

f. Performing calculations or assessments regarding patient treatments that may constitute a misadministration.

2. If the qualified medical physicist is not a full-time employee of the registrant, the operating procedures required by subsection H of this section shall also specifically address how the qualified medical physicist is to be contacted for problems or emergencies, as well as the specific actions, if any, to be taken until the qualified medical physicist can be contacted.

H. Operating procedures.

1. Only individuals approved by the authorized user, radiation safety officer, or qualified medical physicist shall be present in the treatment room during treatment;

2. Electronic brachytherapy devices shall not be made available for medical use unless the requirements of 12VAC5-481-3400 A and subsections I and J of this section have been met;

3. The electronic brachytherapy device shall be inoperable, either by hardware or password, when unattended by qualified staff or service personnel;

4. During operation, the electronic brachytherapy device operator shall monitor the position of all persons in the treatment room and all persons entering the treatment room to prevent entering persons from unshielded exposure from the treatment beam;

5. If a patient must be held in position during treatment, mechanical supporting or restraining devices shall be used;

6. Written procedures shall be developed, implemented, and maintained for responding to an abnormal situation. These procedures shall include:

a. Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions; and

b. The names and telephone numbers of the authorized users, the qualified medical physicist, and the radiation safety officer to be contacted if the device or console operates abnormally;

7. A copy of the current operating and emergency procedures shall be physically located at the electronic brachytherapy device control console. If the control console is integral to the electronic brachytherapy device, the required procedures shall be kept where the operator is located during electronic brachytherapy device operation;

8. Instructions shall be posted at the electronic brachytherapy device control console to inform the operator of the names and telephone numbers of the authorized users, the qualified medical physicist, and the radiation safety officer to be contacted if the device or console operates abnormally; and

9. The radiation safety officer, or his designee, and an authorized user shall be notified as soon as possible if the patient has a medical emergency, suffers injury, or dies. The radiation safety officer or the qualified medical physicist shall inform the manufacturer of the event.

I. Safety precautions for electronic brachytherapy devices.

1. A qualified medical physicist shall determine which persons in the treatment room require monitoring when the beam is energized;

2. An authorized user and a qualified medical physicist shall be physically present during the initiation of all patient treatments involving the electronic brachytherapy device;

3. A qualified medical physicist and either an authorized user or a nonauthorized user (physician or electronic brachytherapy device operator) under the supervision of an authorized user, who has been trained in the operation and emergency response for the electronic brachytherapy device, shall be physically present during continuation of all patient treatments involving the electronic brachytherapy device;

4. When shielding is required by subdivision C 4 of this section, the electronic brachytherapy device operator shall use a survey meter to verify proper placement of the shielding immediately upon initiation of treatment. Alternatively, a qualified medical physicist shall designate shield locations sufficient to meet the requirements of 12VAC5-481-640 for any individual, other than the patient, in the treatment room; and

5. All personnel in the treatment room shall remain behind shielding during treatment. A qualified medical physicist shall approve any deviation from this requirement and shall designate alternative radiation safety protocols, compatible with patient safety, to provide an equivalent degree of protection.

J. Electronic brachytherapy source calibration measurements.

1. Calibration of the electronic brachytherapy source output for an electronic brachytherapy device subject to this section shall be performed by or under the direct supervision of a qualified medical physicist;

2. Calibration of the electronic brachytherapy source output shall be made for each electronic brachytherapy source after any repair affecting the x-ray beam generation, or when indicated by the electronic brachytherapy source quality assurance checks;

3. Calibration of the electronic brachytherapy source output shall utilize a dosimetry system described in 12VAC5-481-3400 C;

4. Calibration of the electronic brachytherapy source output shall include, as applicable, determination of:

a. The output within 2.0% of the expected value, if applicable, or determination of the output if there is no expected value;

b. Timer accuracy and linearity over the typical range of use;

c. Proper operation of back-up exposure control devices;

d. Evaluation that the relative dose distribution about the source is within 5.0% of that expected; and

e. Source positioning accuracy to within one millimeter within the applicator;

5. Calibration of the x-ray source output required by subdivisions 1 through 4 of this subsection shall be in accordance with current published recommendations from a recognized national professional association with expertise in electronic brachytherapy, when available. In the absence of a calibration protocol published by a national professional association, the manufacturer's calibration protocol shall be followed; and

6. The registrant shall maintain a record of each calibration in an auditable form for the duration of the registration. The record shall include the date of the calibration; the manufacturer's name, model number, and serial number for the electronic brachytherapy device and a unique identifier for its electronic brachytherapy source; the model numbers and serial numbers of the instrument used to calibrate the electronic brachytherapy device; and the name and signature of the qualified medical physicist responsible for performing the calibration.

K. Periodic and day-of-use quality assurance checks for electronic brachytherapy devices.

1. Quality assurance checks shall be performed on each electronic brachytherapy device:

a. At the beginning of each day of use;

b. Each time the device is moved to a new room or each day of use at each operating location for a self-contained electronic brachytherapy unit transported in a van or trailer; and

c. After each x-ray tube installation.

2. The registrant shall perform periodic quality assurance checks required by subdivision 1 of this subsection in accordance with procedures established by the qualified medical physicist.

3. To satisfy the requirements of subdivision 1 of this subsection, radiation output quality assurance checks shall include at a minimum:

a. Verification that output of the electronic brachytherapy source falls within 3.0% of expected values, as appropriate for the device, as determined by:

(1) Output as a function of time, or

(2) Output as a function of setting on a monitor chamber.

b. Verification of the consistency of the dose distribution to within 3.0% of that found during calibration required by subsection J of this section; and

c. Validation of the operation of positioning methods to ensure that the treatment dose exposes the intended location within one millimeter.

4. The registrant shall use a dosimetry system that has been intercompared within the previous 12 months with the dosimetry system described in 12VAC5-481-3400 C 1 to make the quality assurance checks required in subdivision 3 of this subsection.

5. The registrant shall review the results of each radiation output quality assurance check according to the following procedures:

a. An authorized user and qualified medical physicist shall be immediately notified if any parameter is not within its acceptable tolerance. The electronic brachytherapy device shall not be made available for subsequent medical use until the qualified medical physicist has determined that all parameters are within the acceptable tolerances;

b. If all radiation output quality assurance check parameters appear to be within the acceptable range, the quality assurance check shall be reviewed and signed by either the authorized user or qualified medical physicist within two days; and

c. The qualified medical physicist shall review and sign the results of each radiation output quality assurance check at intervals not to exceed 30 days.

6. To satisfy the requirements of subdivision 1 of this subsection, safety device quality assurance checks shall, at a minimum, assure:

a. Proper operation of radiation exposure indicator lights on the electronic brachytherapy device and on the control console;

b. Proper operation of viewing and intercom systems in each electronic brachytherapy facility, if applicable;

c. Proper operation of radiation monitors, if applicable;

d. The integrity of all cables, catheters, or parts of the device that carry high voltages; and

e. Connecting guide tubes, transfer tubes, transfer-tube-applicator interfaces, and treatment spacers are free from any defects that interfere with proper operation.

7. If the results of the safety device quality assurance checks required in subdivision 6 of this subsection indicate the malfunction of any system, a registrant shall secure the control console in the "OFF" position and not use the electronic brachytherapy device except as may be necessary to repair, replace, or check the malfunctioning system.

8. The registrant shall maintain a record of each quality assurance check required by subdivisions 3 and 7 of this subsection in an auditable form for three years.

a. The record shall include the date of the quality assurance check; the manufacturer's name, model number, and serial number for the electronic brachytherapy device; the name and signature of the individual who performed the periodic quality assurance check; and the name and signature of the qualified medical physicist who reviewed the quality assurance check; and

b. For radiation output quality assurance checks required by subdivision 3 of this subsection, the record shall also include the unique identifier for the electronic brachytherapy source and the manufacturer's name, model number, and serial number for the instrument used to measure the radiation output of the electronic brachytherapy device.

L. Therapy-related computer systems. The registrant shall perform acceptance testing on the treatment planning system of electronic brachytherapy-related computer systems in accordance with current published recommendations from a recognized national professional association with expertise in electronic brachytherapy, when available. In the absence of an acceptance testing protocol published by a national professional association, the manufacturer's acceptance testing protocol shall be followed.

1. Acceptance testing shall be performed by or under the direct supervision of a qualified medical physicist. At a minimum, the acceptance testing shall include, as applicable, verification of:

a. The source-specific input parameters required by the dose calculation algorithm;

b. The accuracy of dose, dwell time, and treatment time calculations at representative points;

c. The accuracy of isodose plots and graphic displays;

d. The accuracy of the software used to determine radiation source positions from radiographic images; and

e. If the treatment-planning system is different from the treatment-delivery system, the accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system.

2. The position indicators in the applicator shall be compared to the actual position of the source or planned dwell positions, as appropriate, at the time of commissioning.

3. Prior to each patient treatment regimen, the parameters for the treatment shall be evaluated and approved by the authorized user and the qualified medical physicist for correctness through means independent of that used for the determination of the parameters.

M. Training.

1. A registrant shall provide instruction, initially and at least annually, to all individuals who operate the electronic brachytherapy device, as appropriate to the individual's assigned duties, in the operating procedures identified in subsection H of this section. If the interval between patients exceeds one year, retraining of the individuals shall be provided.

2. In addition to the requirements of 12VAC5-481-3390 C for therapeutic radiation machine authorized users and 12VAC5-481-3390 D for qualified medical physicists, the therapeutic radiation machine authorized users and qualified medical physicists shall also receive device-specific instruction initially from the manufacturer and annually from either the manufacturer or other qualified trainer. The training shall be of a duration recommended by a recognized national professional association with expertise in electronic brachytherapy, when available. In the absence of any training protocol recommended by a national professional association, the manufacturer's training protocol shall be followed. The training shall include, but not be limited to:

a. Device-specific radiation safety requirements;

b. Device operation;

c. Clinical use for the types of use approved by the U.S. Food and Drug Administration;

d. Emergency procedures, including an emergency drill; and

e. The registrant's quality assurance program.

3. A registrant shall retain a record of individuals receiving instruction required by subdivisions 1 and 2 of this subsection for three years. The record shall include a list of the topics covered, the date of the instruction, the names of the attendees, and the names of the individuals who provided the instruction.

N. Mobile electronic brachytherapy service. A registrant providing mobile electronic brachytherapy service shall, at a minimum:

1. Check all survey instruments before medical use at each address of use or on each day of use, whichever is more restrictive.

2. Account for the electronic brachytherapy source in the electronic brachytherapy device before departure from the client's address.

3. Perform at each location on each day of use all of the required quality assurance checks specified in subsection K of this section to assure proper operation of the device.

History

• Statutory Authority: §§ 32.1-12 and 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 17, eff. June 5, 2016.

12VAC5-481-3453 Other use of electronically produced radiation to deliver therapeutic radiation dosage

A person shall not utilize any device that is designed to electronically generate a source of ionizing radiation to deliver therapeutic radiation dosage and that is not appropriately regulated under any existing category of therapeutic radiation machine until:

1. The applicant or registrant has, at a minimum, provided the agency with:

a. A detailed description of the device and its intended application;

b. Facility design requirements, including shielding and access control;

c. Documentation of appropriate training for authorized user physicians and qualified medical physicists;

d. Methodology for measurement of dosages to be administered to patients or human research subjects;

e. Documentation regarding calibration, maintenance, and repair of the device, as well as instruments and equipment necessary for radiation safety;

f. Radiation safety precautions and instructions; and

g. Other information requested by the agency in its review of the application; and

2. The applicant or registrant has received written approval from the agency to utilize the device in accordance with the regulations and specific conditions the agency considers necessary for the medical use of the device.

History

• Statutory Authority: §§ 32.1-12 and 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 17, eff. June 5, 2016.

12VAC5-481-3460 Purpose

This part establishes radiation protection standards for the possession, use, transfer, and disposal of Technologically Enhanced Naturally Occurring Radioactive Materials (TENORM).

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-3470 Scope

A. These regulations apply to any person who receives, owns, possesses, uses, processes, transfers, distributes, or disposes of TENORM.

B. The regulations in this part address the introduction of TENORM into products in which neither the TENORM, nor the radiation emitted from the TENORM, is considered to be beneficial to the products.

C. The manufacture and distribution of products containing TENORM, in which the TENORM and/or its emitted radiation is considered to be a beneficial attribute, are licensed under the provisions of Part III (12VAC5-481-380 et seq.) of this chapter.

D. This part does not apply to radionuclides for which NRC retains exclusive jurisdiction.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-3480 Exemptions

A. Persons who receive, own, possess, use, process, transfer, distribute, or dispose of TENORM are exempt from the requirements of this part (12VAC5-481-3460 et seq.) of this chapter with respect to any combination of radium-226 and radium-228 if the materials contain, or are contaminated at, concentrations less than 185 Bq/kg (5 pCi/gm) excluding natural background. This does not apply to consumer or retail products that are discussed in 12VAC5-481-3560 C and 12VAC5-481-3570. Using purposeful dilution to render TENORM waste exempt shall not be allowed without prior agency approval.

B. Persons who receive products or materials containing TENORM distributed in accordance with a specific license issued by the agency pursuant to 12VAC5-481-3540 1, or to an equivalent license issued by another licensing state, are exempt from these regulations with regard to those products or materials.

C. The distribution, including custom blending, possession, and use of fertilizers containing TENORM, is exempt from the requirements of this part.

D. TENORM waste regulated by CERCLA (The Comprehensive Environmental Response, Compensation, and Liability Act) or RCRA (Resources Conservation and Recovery Act) are exempt from this part.

E. The transportation and storage incident to transportation are governed by other parts of these regulations.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3490 Standards for radiation protection for TENORM

A. No person licensed under 12VAC5 481-3530 or 12VAC5-481-3540 shall conduct operations, use, or transfer TENORM in a manner such that a member of the public will receive an annual total effective dose equivalent in excess of 1mSv (100 mrem) per year from all licensed sources including TENORM.

B. Persons subject to a license under this part shall comply with radiation protection standards set out in Part IV (12VAC5-481-600 et seq.) of this chapter.

C. Doses from indoor radon and its progeny shall not be included in total effective dose equivalent calculations.

D. No person shall release TENORM for unrestricted use in such a manner that the reasonably maximally exposed individual will receive an annual total effective dose equivalent from the released TENORM in excess of 1mSv (100 mrem) per year excluding natural background.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3500 Protection of Workers During Operations

Each person subject to a specific license under Part XVI of this chapter shall conduct operations in compliance with the standards for radiation protection set out in other parts of these regulations.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-3510 Release for unrestricted use

Each person subject to a license under this part shall:

1. Not transfer or release for unrestricted use facilities or equipment contaminated with TENORM in excess of levels in Table 6.

| | Table 6. Acceptable Surface Contamination Levels¹ for TENORM | | | | | --- | --- | --- | --- | --- | | | | AVERAGE^2,3,6 | MAXIMUM^2,4,6 | REMOVABLE^2,3,5,6 | | | Alpha | 5,000 dpm/100 cm² | 15,000 dpm/100 cm² | 1,000 dpm/100 cm² | | | Beta-gamma | 5,000 dpm/100 cm² | 15,000 dpm/100 cm² | 1,000 dpm/100 cm² | | | ¹Where surface contamination by both alpha and beta-gamma emitting nuclides exists, the limits established for alpha and beta-gamma emitting nuclides should apply independently. ²As used in this table, dpm (disintegrations per minute) means the rate of emission by radioactive material as determined by correcting the counts per minute observed by an appropriate detector for background, efficiency, and geometric factors associated with the instrumentation. ³Measurements of average contamination level should not be averaged over more than one square meter. For objects of less surface area, the average should be derived for each object. ⁴The maximum contamination level applies to an area of not more than 100 cm². ⁵The amount of removable radioactive material per 100 cm² of surface area should be determined by wiping that area with dry filter or soft absorbent paper, applying moderate pressure, and assessing the amount of radioactive material on the wipe with an appropriate instrument of known efficiency. When removable contamination on objects of surface area A (where A is less than 100 sq. cm) is determined, the entire surface should be wiped and the contamination level multiplied by 100/A to convert a "per 100 sq. cm" basis. ⁶The average and minimum radiation levels associated with surface contamination resulting from beta-gamma emitters should not exceed 0.2 mrad/hr (2μGy/hr) at 1 cm, respectively, measured through not more than 7 milligrams per square centimeter of total absorber. | | | |

2. Not transfer or release for unrestricted use equipment contaminated with TENORM in excess of a surface gamma radiation level of 200 μrem/hr at 1 cm excluding natural background; and

3. Not transfer land for unrestricted use where the concentration of radium-226 or radium-228 in soil averaged over any 100 square meters exceeds the background level by more than 185 Bq/kg (5 pCi/gm), averaged over any 15 cm layer of soil below the surface, unless compliance with 12VAC5-481-3490 B through D can be demonstrated.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3520 Disposal and transfer of waste for disposal

A. Each person subject to a license under this part shall manage and dispose of wastes containing TENORM:

1. By transfer of the wastes for disposal to a facility licensed under requirements for uranium or thorium byproduct materials in either 40 CFR Part 192 or 10 CFR Part 40 Appendix R;

2. By transfer of the wastes for disposal to a disposal facility licensed by the NRC, or another agreement state; or

3. In accordance with alternate methods authorized by the agency upon application or upon the agency's initiative, consistent with 12VAC5-481-3490 and where applicable the Clean Water Act, Safe Drinking Water Act and other requirements of the United States Environmental Protection Agency for disposal of such wastes.

B. Equipment contaminated with TENORM in excess of levels specified in Table 6 of this part, which is to be disposed of as waste, shall be disposed of:

1. So as to prevent any reintroduction into commerce or unrestricted use; and

2. Within disposal areas specifically designed to meet the criteria of subsection A of this section.

C. Transfers of waste containing TENORM for disposal shall be made only to a person specifically authorized by the NRC, or another agreement state, to receive such waste.

D. Records of disposal, including manifests, shall be maintained pursuant to the provisions of Part IV (12VAC5-481-600 et seq.) of this chapter.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3530 General license

A. Subject to the requirements of 12VAC5-481-3490 through 12VAC5-481-3520 and 12VAC5-481-3540, a general license is hereby issued to possess, own, use, transfer, distribute or dispose of TENORM without regard to quantity.

B. This general license does not authorize the manufacturing of products containing TENORM in concentrations greater than those specified in 12VAC5-481-3480 A nor the receipt and disposal of wastes from other persons.

C. The decontamination of equipment, facilities, and land shall be performed only by persons specifically licensed by the agency, NRC or another agreement state to conduct such work. However, employees or contractors under control and supervision of a general licensee can perform routine maintenance on equipment, facilities, and land owned or controlled by the general licensee. Maintenance that provides a different pathway for exposure than is found in daily operations and that increases the potential for additional exposure is not considered routine.

D. Any person subject to the general license issued by this section shall notify the agency. Such notification shall include:

1. Name and address of the licensee;

2. Location and description of the facility or operation; and

3. Description of the TENORM including estimates of the amount and extent of TENORM.

E. Transfer of material or real property.

1. The transfer of TENORM not exempt from these regulations from one general licensee to another general licensee is authorized if:

a. The equipment and facilities contaminated with TENORM are to be used by the recipient for the same purpose; or

b. The transfer of control or ownership of land contaminated with TENORM includes an annotation of the deed records, or notice to owners of surface and mineral rights, to indicate the presence of TENORM.

2. Transfers not made in accordance with subdivision 1 of this subsection require prior approval by the agency.

3. Transfers made under subdivision 1 of this subsection do not relieve the general licensee who makes the transfer from the responsibilities of assessing the extent of TENORM contamination or material present, informing the general licensee receiving the TENORM of these assessments, and maintaining records required by this chapter.

4. A general licensee intending to transfer material or real property for unrestricted use shall document compliance with the requirements of 12VAC5-481-3510.

F. Distribution of TENORM products between general licensees. The distribution of TENORM products not exempt from these regulations from one general licensee to another general licensee is authorized provided the product is accompanied by labels or manifests which identify the type and amount of TENORM.

G. The agency may, by written notice, require any person authorized by a general license to apply for and obtain a specific license. The notice shall state the reason or reasons for requiring a specific license.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3540 Specific Licenses

Unless otherwise exempt, a specific license is required to:

1. Manufacture and distribute any material or product containing TENORM unless authorized by 12VAC5-481-3530 F, exempted under the provisions of 12VAC5-481-3480, or licensed under the provisions of Part III (12VAC5-481-380 et seq.) of this chapter;

2. Except as provided in 12VAC5-481-3530 C, decontaminate equipment or land not otherwise exempted under the provisions of 12VAC5-481-3480 or facilities contaminated with TENORM in excess of the levels set forth in 12VAC5-481-3510, as applicable; for purposes of this subsection, the term "decontaminate" shall not include maintenance that incidentally results in removal of contamination;

3. Receive TENORM from other persons for disposal.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-3550 Filing application for specific licenses

A. Applications for specific licenses shall be filed in a manner and on a form prescribed by the agency.

B. The agency may at any time after the filing of the original application, and before the expiration of the license, require further statements in order to enable the agency to determine whether the application should be granted or denied or whether a license should be modified or revoked.

C. Each application shall be signed by the applicant or licensee or a person duly authorized to act for and on the licensee's behalf.

D. An application for a license may include a request for a license authorizing one or more activities.

E. Each application for a specific license shall be accompanied by a fee of $50.

F. In an application, the applicant may incorporate by reference information contained in previous applications, statements, or reports filed with the agency provided such references are clear and specific.

G. Applications and documents submitted to the agency may be made available for public inspection.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-3560 Requirements for the issuance of specific licenses

A. A license application will be approved if the agency determines that:

1. The applicant is qualified by reason of training and experience to use the TENORM in question for the purpose requested in accordance with these rules in such a manner as to protect the public health and safety or property;

2. The applicant's proposed equipment, facilities, and procedures are adequate to protect the public health and safety or property;

3. The issuance of the license will not be inimical to the health and safety of the public;

4. The applicant satisfied all applicable special requirements in this part;

5. The applicant has met the financial surety requirements of 12VAC5-481-450 C; and

6. The applicant has adequately addressed the following items in the application:

a. Procedures and equipment for monitoring and protecting workers;

b. An evaluation of the radiation levels and concentrations of contamination expected during normal operations;

c. Operating and emergency procedures, including procedures for waste reduction and quality assurance of items released for unrestricted use; and

d. A method for managing the radioactive material removed from contaminated equipment and facilities.

B. An application for a specific license to decontaminate equipment, land, or facilities contaminated with TENORM in excess of the levels set forth in 12VAC5-481-3480 A, 12VAC5-481-3510 2, or Table 6, as applicable, and to dispose of the resulting waste will be approved if:

1. The applicant satisfies the general requirements specified in subsection A of this section; and

2. The applicant has adequately addressed the following items in the application:

a. Procedures and equipment for monitoring and protection of workers;

b. An evaluation of the radiation levels and concentrations of contamination expected during normal operations;

c. Operating and emergency procedures, including procedures for waste reduction and quality assurance of items released for unrestricted use; and

d. Method of disposing of the TENORM removed from contaminated equipment, facilities, and/or land.

C. An application for a specific license to transfer materials or manufacture or distribute products containing TENORM to persons exempted from these regulations pursuant to 12VAC5-481-3530 B will be approved if:

1. The applicant satisfies the general requirements specified in subsection A of this section;

2. The TENORM is not contained in any food, beverage, cosmetic, drug, or other commodity designed for ingestion or inhalation by, or application to, a human being; and

3. The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, and conditions of handling, storage, use, and disposal of the TENORM material or product to demonstrate that the material or product will meet the safety criteria set forth in 12VAC5-481-3570. The information shall include:

a. A description of the material or product and its intended use or uses;

b. The type, quantity, and concentration of TENORM in each material or product;

c. The chemical and physical form of the TENORM in the material or product, and changes in chemical and physical form that may occur during the useful life of the material or product;

d. An analysis of the solubility in water and body fluids of the TENORM in the material or product;

e. The details of manufacture and design of the material or product relating to containment and shielding of the TENORM and other safety features under normal and severe conditions of handling, storage, use, reuse, and disposal of the material or product;

f. The degree of access of human beings to the material or product during normal handling, use, and disposal;

g. The total quantity of TENORM expected to be distributed annually in the material or product;

h. The expected useful life of the material or product;

i. The proposed method of labeling or marking each unit of the material or product with identification of the manufacturer or initial transferor of the product and the radionuclides and quantity of TENORM in the material or product;

j. The procedures for prototype testing of the material or product to demonstrate the effectiveness of the containment, shielding, and other safety features under both normal and severe conditions of handling, storage, use, reuse, and disposal;

k. The results of the prototype testing of the material or product, including any change in the form of the TENORM contained in it, the extent to which the TENORM may be released to the environment, any change in radiation levels, and any other changes in safety features;

l. The estimated external radiation doses and dose commitments relevant to the safety criteria in 12VAC5-481-3570 and the basis for such estimates;

m. A determination that the probabilities with respect to doses referred to in 12VAC5-481-3570 meet the safety criteria;

n. The quality control procedures to be followed in the production of production lots of the material or product, and the quality control standards the material or product will be required to meet; and

o. Any additional information, including experimental studies and tests, required by the agency to facilitate a determination of the radiation safety of the material or product.

D. Notwithstanding the provisions of subdivision 2 of 12VAC5-481-3570, the agency may deny an application for a specific license if the end uses of the product are frivolous or cannot be reasonably foreseen.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3570 Safety Criteria for Products

An applicant for a license under 12VAC5-481-3560 C shall demonstrate that the product is designed and will be manufactured so that:

1. In normal use and disposal of a single exempt item, and in normal handling and storage of the quantities of exempt items likely to accumulate in one location during marketing, distribution, installation, and servicing of the product, it is unlikely that the TEDE in any one year, to a suitable sample of the group of individuals expected to be most highly exposed to radiation or radioactive material from the product will exceed the doses in Column I of 12VAC5-481-3580.

2. In use and disposal of a single exempt item and in handling and storage of the quantities of exempt items likely to accumulate in one location during marketing, distribution, installation, and servicing of the product, the probability is low (not more than one failure per year for each 10,000 exempt units distributed) that the containment, shielding, or other safety features of the product would fail under such circumstances that a person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in Column II of the table in 12VAC5-481-3580 and the probability is negligible (not more than one such failure per year for each one millions exempt units distributed) that a person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in Column III of the table in 12VAC5-481-3580. It is the intent of this paragraph that as the magnitude of the potential dose increases above that permitted under normal conditions, the probability that any individual will receive such a dose must decrease. The probabilities have been expressed in general terms to emphasize the approximate nature of the estimates that are to be made. The above values may be used a guidelines in estimating compliance with the criteria.

3. It is unlikely that there will be a significant reduction in the effectiveness of the containment, shielding, or other safety features of the product from wear and abuse likely to occur in normal handling and use of the product during its useful life.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-3580 Table of organ doses

| Part of Body | Column I (rem) | Column II (rem) | Column III (rem) | Column IV (rem) | | --- | --- | --- | --- | --- | | Whole body; head and trunk; active blood-forming organs; gonads; or lens of eye | 0.001 | 0.01 | 0.5 | 15 | | Hands and forearms; feet and ankles; localized areas of skin averaged over areas no larger than 1 square centimeter | 0.015 | 0.15 | 7.5 | 200 | | Other organs | 0.003 | 0.03 | 1.5 | 50 |

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3590 Issuance of Specific Licenses

A. Upon a determination that an application meets the requirements of these regulations, the agency will issue a specific license authorizing the proposed activity in such form and containing such conditions and limitations as it deems appropriate or necessary.

B. The agency may incorporate in any license at the time of issuance, or thereafter by amendment, such additional requirements and conditions with respect to the licensee's receipt, possession, use, and transfer of TENORM subject to this part as it deems appropriate or necessary in order to:

1. Protect public health and safety or property;

2. Require such reports and the keeping of such records, and to provide for such inspections of activities under the license as may be appropriate or necessary; and

3. Prevent loss, theft, or loss of control of TENORM subject to this part.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-3600 Conditions of specific licenses issued under 12VAC5-481-3560

A. General terms and conditions.

1. Each license issued pursuant to this part shall be subject to all the provisions of the Act, now or hereafter in effect, and to all rules, regulations, and orders of the agency.

2. No license issued or granted under this part and no right to possess or utilize TENORM granted by any license issued pursuant to this part shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person unless the agency shall, after securing full information, find that the transfer is in accordance with the provisions of the Act, and shall give its consent in writing.

3. Each person licensed by the agency pursuant to this part shall confine use and possession of the TENORM licensed to the locations and purposes authorized in the license.

4. Each person licensed by the agency pursuant to this part is subject to the general license provisions of 12VAC5-481-3500, 12VAC5-481-3510, and 12VAC5-481-3520.

5. Each licensee shall:

a. Notify the agency, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy under any Chapters of Title II (Bankruptcy) of the United States Code (11 USC) by or against a licensee, an entity (as that term is defined in 11 USC § 101 (15)) controlling a licensee or listing the license or licensee as property of the estate; or an affiliate (as that term is defined in 11 USC § 101 (2)) of the licensee.

b. Indicate in their bankruptcy notification the bankruptcy court in which the petition for bankruptcy was filed; and the date of the filing of the petition.

B. Quality control, labeling, and reports of transfer. Each person licensed under 12VAC5-481-3560 C shall:

1. Carry out adequate control procedures in the manufacture of the product to assure that each production lot meets the quality control standards approved by the agency;

2. Label or mark each unit so that the manufacturer, processor, producer, or initial transferor of the material or product and the TENORM in the product can be identified; and

3. Maintain records identifying, by name and address, each person to whom TENORM is transferred for use under 12VAC5-481-3480 B or the equivalent regulations of another licensing state, and stating the kinds, quantities, and uses of TENORM transferred. An annual summary report stating the total quantity of each radionuclide transferred under the specific license shall be filed with the agency. Each report shall cover the year ending December 31, and shall be filed within 90 days thereafter. If no transfers of TENORM have been made pursuant to 12VAC5-481-3560 C during the reporting period, the report shall so indicate.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3610 Expiration and termination of specific licenses

A. Except as provided in subdivision D 6 of this section and 12VAC5-481-3620 B, each specific license shall expire at the end of the specified day in the month and year stated therein.

B. Each licensee shall notify the agency in writing and request termination of the license when the licensee decides to terminate all activities involving TENORM authorized under the license. This notification and request for termination of the license must include the reports and information specified in subdivision D 4 of this section. The licensee is subject to the provisions of subsections D and E of this section, as applicable.

C. No less than 30 days before the expiration date specified in a specific license, the licensee shall either:

1. Submit an application for license renewal under 12VAC5-481-3620; or

2. Notify the agency in writing, under subsection B of this section, if the licensee decides to discontinue all activities involving TENORM.

D. If a licensee does not submit an application for license renewal under 12VAC5-481-3620, the licensee shall, on or before the expiration date specified in the license:

1. Terminate use of TENORM;

2. Remove TENORM contamination consistent with the requirements of 12VAC5-481-3510.

3. Properly dispose of TENORM; and

4. Submit a report of disposal of TENORM and radiation surveys to confirm the absence of TENORM or to establish the levels of residual TENORM contamination. The licensee shall, as appropriate:

a. Report levels of radiation in units of microroentgens per hour of beta and gamma radiation at one centimeter and gamma radiation at one meter from surfaces and report levels of radioactivity in units of disintegrations per minute (or microcuries) per 100 square centimeters removable and fixed on surfaces, microcuries or Becquerel per milliliter in water, and picocuries or becquerels per gram in contaminated solids such as soils or concrete; and

b. Specify the instruments used and certify that each instrument is properly calibrated and tested.

5. If levels of residual activity are less than those established in 12VAC5-481-3510, the licensee shall so certify. If the agency determines that this certification and the information submitted under subdivision 4 of this subsection is adequate and surveys confirm the findings, the agency will notify the licensee in writing that the license is terminated.

6. If levels of residual TENORM are not in conformance with criteria established in 12VAC5-481-3510, the license continues in effect beyond the expiration date, if necessary, with respect to possession of residual TENORM until the agency notifies the licensee in writing that the license is terminated. During this time, the licensee is subject to the provisions of subsection E of this section. In addition to the information submitted under subdivision 4 of this subsection, the licensee shall submit a plan, if appropriate, for decontaminating the location(s) and disposing of this subsection of the residual TENORM.

E. Each licensee who possesses residual TENORM under subdivision D 6 of this section, following the expiration date specified in the license, shall:

1. Be limited to actions involving TENORM related to preparing the locations for release for unrestricted use; and

2. Continue to control entry to restricted areas until the locations are suitable for release for unrestricted use and the agency notifies the licensee in writing that the license is terminated.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3620 Renewal of specific licenses

A. Applications for renewal of specific licenses shall be filed in accordance with 12VAC5-481-3550.

B. In any case in which a licensee, not less than 30 days prior to expiration of an existing license, has filed an application in proper form for renewal or for a new license authorizing the same activities, such existing license shall not expire until final action by the agency.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-3630 Amendment of specific licenses at request of licensee

Applications for amendment of a license shall be filed in accordance with 12VAC5-481-3550 and shall specify the respects in which the licensee desires the license to be amended and the grounds for such amendment.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-3640 Agency action on applications to renew and amend specific licenses

In considering an application by a licensee to renew or amend the license, the agency will apply the criteria set forth in 12VAC5-481-3560.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-3650 Modification and revocation of specific licenses

A. The terms and conditions of all licenses shall be subject to amendment, revision, or modification or the license may be suspended or revoked by reason of amendments to the Act, or by reason of rules, regulations, and orders issued by the agency.

B. Any license may be revoked, suspended, or modified, in whole or in part, for any material false statement in the application or any statement of fact required under provisions of the Act, or because of conditions revealed by such application or statement of fact or any report, record, or inspection or other means which would warrant the agency to refuse to grant a license on an original application, or for violation of, or failure to observe any of the terms and conditions of the Act, or of the license, or of any rule, regulation, or order of the agency.

C. Except in cases of willfulness or those in which the public health, interest or safety requires otherwise, the agency shall not modify, suspend or revoke a license prior to the institution of proceedings unless facts or conduct that may warrant such action shall have been called to the attention of the licensee in writing and the licensee shall have been accorded an opportunity to demonstrate or achieve compliance with all lawful requirements.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3660 Reciprocal recognition of specific licenses

Subject to these regulations, any person who holds a specific license from an agreement state or a licensing state, and issued by the agency having jurisdiction where the licensee maintains an office for directing the licensed activity and at which radiation safety records are normally maintained, is hereby granted a general license to conduct the activities authorized in such licensing document within this state for a period not in excess of 180 days in any calendar year provided that:

1. The licensing document does not limit the activity authorized by such document to specified installations or locations;

2. The out-of-state licensee notifies the agency in writing at least three days prior to engaging in such activity. Such notification shall indicate the location, period, and type of proposed possession and use within the State, and shall be accompanied by a copy of the pertinent licensing document. If, for a specific case, the three-day period would impose an undue hardship on the out-of-state licensee, the licensee may, upon application to the agency, obtain permission to proceed sooner. The agency may waive the requirement for filing additional written notifications during the remainder of the calendar year following the receipt of the initial notification from a person engaging in activities under the general license provided in subdivision 1 of this section;

3. The out-of-state licensee complies with all applicable regulations of the agency and with all the terms and conditions of the licensing document, except any such terms and conditions which may be inconsistent with applicable regulations of the agency;

4. The out-of-state licensee supplies such other information as the agency may request; and

5. The out-of-state licensee shall not transfer or dispose of TENORM possessed or used under the general license provided in subsection A of this section, except by transfer to a person:

a. Specifically licensed by the agency or by another licensing state to receive such TENORM; or

b. Exempt from the requirements for a license for such TENORM under 12VAC5-481-3480.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.

12VAC5-481-3670 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; repealed, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3680 Assigned protection factors for respirators

| | Operating mode | Assigned Protection Factors | | --- | --- | --- | | I. Air Purifying Respirators (Particulate^b only)^c: | | | | Filtering facepiece disposable^d | Negative Pressure | ^(d) | | Facepiece, half^e | Negative Pressure | 10 | | Facepiece, full | Negative Pressure | 100 | | Facepiece, half | Powered air-purifying respirators | 50 | | Facepiece, full | Powered air-purifying respirators | 1000 | | Helmet/hood | Powered air-purifying respirators | 1000 | | Facepiece, loose-fitting | Powered air-purifying respirators | 25 | | II. Atmosphere-supplying respirators (particulate, gases and vapors^f): | | | | 1. Air-line respirator: | | | | Facepiece, half | Demand | 10 | | Facepiece, half | Continuous Flow | 50 | | Facepiece, half | Pressure Demand | 50 | | Facepiece, full | Demand | 100 | | Facepiece, full | Continuous Flow | 1000 | | Facepiece, full | Pressure Demand | 1000 | | Helmet/hood | Continuous Flow | 1000 | | Facepiece, loose-fitting | Continuous Flow | 25 | | Suit | Continuous Flow | ^(g) | | 2. Self-contained breathing Apparatus (SCBA): | | | | Facepiece, full | Demand | ^h100 | | Facepiece, full | Pressure Demand | ⁱ10,000 | | Facepiece, full | Demand, Recirculating | ^h100 | | Facepiece, full | Positive Pressure Recirculating | ⁱ10,000 | | III. Combination Respirators: | | | | Any combination of air-purifying and atmosphere-supplying respirators | Assigned protection factor for type and mode of operation as listed above. | | | ^aThese assigned protection factors apply only in a respiratory protection program that meets the requirements of this section. They are applicable only to airborne radiological hazards and may not be appropriate to circumstances when chemical or other respiratory hazards exist instead of, or in addition to, radioactive hazards. Selection and use of respirators for such circumstances shall also comply with Department of Labor regulations. Radioactive contaminants for which the concentration values in Table 1, Column 3 of Appendix B to 10 CFR Part 20 are based on internal dose due to inhalation may, in addition, present external exposure hazards at higher concentrations. Under these circumstances, limitations on occupancy may have to be governed by external dose limits. ^bAir purifying respirators with APF <100 shall be equipped with particulate filters that are at least 95% efficient. Air purifying respirators with APF = 100 shall be equipped with particulate filters that are at least 99% efficient. Air purifying respirators with APFs >100 shall be equipped with particulate filters that are at least 99.97% efficient. ^cThe licensee may apply to VDH for the use of an APF greater than 1 for absorbent cartridges as protection against airborne radioactive gases and vapors (e.g., radioiodine). ^dLicensees may permit individuals to use this type of respirator who have not been medically screened or fit tested on the device provided that no credit be taken for their use in estimating intake or dose. It is also recognized that it is difficult to perform an effective positive or negative pressure pre-use user seal check on this type of device. All other respiratory protection program requirements listed in 12VAC5-481-820 apply. An assigned protection factor has not been assigned for these devices. However, an APF equal to 10 may be used if the licensee can demonstrate a fit factor of at least 100 by use of a validated or evaluated, qualitative or quantitative fit test. ^eUnder-chin type only. No distinction is made in this section between elastomeric half-masks with replaceable cartridges and those designed with the filter medium as an integral part of the facepiece (e.g., disposable or reusable disposable). Both types are acceptable so long as the seal area of the latter contains some substantial type of seal-enhancing material such as rubber or plastic, the two or more suspension straps are adjustable, the filter medium is at least 95 percent efficient and all other requirements of this section are met. ^fThe assigned protection factors for gases and vapors are not applicable to radioactive contaminants that present an absorption or submersion hazard. For tritium oxide vapor, approximately one-third of the intake occurs by absorption through the skin so that an overall protection factor of 3 is appropriate when atmosphere-supplying respirators are used to protect against tritium oxide. Exposure to radioactive noble gases is not considered a significant respiratory hazard, and protective actions for these contaminants should be based on external (submersion) dose considerations. ^gNo NIOSH approval schedule is currently available for atmosphere supplying suits. This equipment may be used in an acceptable respiratory protection program as long as all the other minimum program requirements, with the exception of fit testing, are met (i.e., 12VAC5-481-820). ^hThe licensee should implement institutional controls to assure that these devices are not used in areas immediately dangerous to life or health (IDLH). ⁱThis type of respirator may be used as an emergency device in unknown concentrations for protection against inhalation hazards. External radiation hazards and other limitations to permitted exposure such as skin absorption shall be taken into account in these circumstances. This device may not be used by any individual who experiences perceptible outward leakage of breathing gas while wearing the device. | | |

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008; amended, Virginia Register Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-3690 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008; repealed, Virginia Register Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-3700 Quantities of licensed materials requiring labeling

| Radionuclide | Abbreviation | Quantity (μCi) | | --- | --- | --- | | Hydrogen-3 | H-3 | 1,000 | | Beryllium-7 | Be-7 | 1,000 | | Beryllium-10 | Be-10 | 1 | | Carbon-11 | C-11 | 1,000 | | Carbon-14 | C-14 | 100 | | Fluorine-18 | F-18 | 1,000 | | Sodium-22 | Na-22 | 10 | | Sodium-24 | Na-24 | 100 | | Magnesium-28 | Mg-28 | 100 | | Aluminum-26 | Al-26 | 10 | | Silicon-31 | Si-31 | 1,000 | | Silicon-32 | Si-32 | 1 | | Phosphorus-32 | P-32 | 10 | | Phosphorus-33 | P-33 | 100 | | Sulfur-35 | S-35 | 100 | | Chlorine-36 | Cl-36 | 10 | | Chlorine-38 | Cl-38 | 1,000 | | Chlorine-39 | Cl-39 | 1,000 | | Argon-39 | Ar-39 | 1,000 | | Argon-41 | Ar-41 | 1,000 | | Potassium-40 | K-40 | 100 | | Potassium-42 | K-42 | 1,000 | | Potassium-43 | K-43 | 1,000 | | Potassium-44 | K-44 | 1,000 | | Potassium-45 | K-45 | 1,000 | | Calcium-41 | Ca-41 | 100 | | Calcium-45 | Ca-45 | 100 | | Calcium-47 | Ca-47 | 100 | | Scandium-43 | Sc-43 | 1,000 | | Scandium-44m | Sc-44m | 100 | | Scandium-44 | Sc-44 | 100 | | Scandium-46 | Sc-46 | 10 | | Scandium-47 | Sc-47 | 100 | | Scandium-48 | Sc-48 | 100 | | Scandium-49 | Sc-49 | 1,000 | | Titanium-44 | Ti-44 | 1 | | Titanium-45 | Ti-45 | 1,000 | | Vanadium-47 | V-47 | 1,000 | | Vanadium-48 | V-48 | 100 | | Vanadium-49 | V-49 | 1,000 | | Chromium-48 | Cr-48 | 1,000 | | Chromium-49 | Cr-49 | 1,000 | | Chromium-51 | Cr-51 | 1,000 | | Manganese-51 | Mn-51 | 1,000 | | Manganese-52m | Mn-52m | 1,000 | | Manganese-52 | Mn-52 | 100 | | Manganese-53 | Mn-53 | 1,000 | | Manganese-54 | Mn-54 | 100 | | Manganese-56 | Mn-56 | 1,000 | | Iron-52 | Fe-52 | 100 | | Iron-55 | Fe-55 | 100 | | Iron-59 | Fe-59 | 10 | | Iron-60 | Fe-60 | 1 | | Cobalt-55 | Co-55 | 100 | | Cobalt-56 | Co-56 | 10 | | Cobalt-57 | Co-57 | 100 | | Cobalt-58m | Co-58m | 1,000 | | Cobalt-58 | Co-58 | 100 | | Cobalt-60m | Co-60m | 1,000 | | Cobalt-60 | Co-60 | 1 | | Cobalt-61 | Co-61 | 1,000 | | Cobalt-62m | Co-62m | 1,000 | | Nickel-56 | Ni-56 | 100 | | Nickel-57 | Ni-57 | 100 | | Nickel-59 | Ni-59 | 100 | | Nickel-63 | Ni-63 | 100 | | Nickel-65 | Ni-65 | 1,000 | | Nickel-66 | Ni-66 | 10 | | Copper-60 | Cu-60 | 1,000 | | Copper-61 | Cu-61 | 1,000 | | Copper-64 | Cu-64 | 1,000 | | Copper-67 | Cu-67 | 1,000 | | Zinc-62 | Zn-62 | 100 | | Zinc-63 | Zn-63 | 1,000 | | Zinc-65 | Zn-65 | 10 | | Zinc-69m | Zn-69m | 100 | | Zinc-69 | Zn-69 | 1,000 | | Zinc-71m | Zn-71m | 1,000 | | Zinc-72 | Zn-72 | 100 | | Gallium-65 | Ga-65 | 1,000 | | Gallium-66 | Ga-66 | 100 | | Gallium-67 | Ga-67 | 1,000 | | Gallium-68 | Ga-68 | 1,000 | | Gallium-70 | Ga-70 | 1,000 | | Gallium-72 | Ga-72 | 100 | | Gallium-73 | Ga-73 | 1,000 | | Germanium-66 | Ge-66 | 1,000 | | Germanium-67 | Ge-67 | 1,000 | | Germanium-68 | Ge-68 | 10 | | Germanium-69 | Ge-69 | 1,000 | | Germanium-71 | Ge-71 | 1,000 | | Germanium-75 | Ge-75 | 1,000 | | Germanium-77 | Ge-77 | 1,000 | | Germanium-78 | Ge-78 | 1,000 | | Arsenic-69 | As-69 | 1,000 | | Arsenic-70 | As-70 | 1,000 | | Arsenic-71 | As-71 | 100 | | Arsenic-72 | As-72 | 100 | | Arsenic-73 | As-73 | 100 | | Arsenic-74 | As-74 | 100 | | Arsenic-76 | As-76 | 100 | | Arsenic-77 | As-77 | 100 | | Arsenic-78 | As-78 | 1,000 | | Selenium-70 | Se-70 | 1,000 | | Selenium-73m | Se-73m | 1,000 | | Selenium-73 | Se-73 | 100 | | Selenium-75 | Se-75 | 100 | | Selenium-79 | Se-79 | 100 | | Selenium-81m | Se-81m | 1,000 | | Selenium-81 | Se-81 | 1,000 | | Selenium-83 | Se-83 | 1,000 | | Bromine-74m | Br-74m | 1,000 | | Bromine-74 | Br-74 | 1,000 | | Bromine-75 | Br-75 | 1,000 | | Bromine-76 | Br-76 | 100 | | Bromine-77 | Br-77 | 1,000 | | Bromine-80m | Br-80m | 1,000 | | Bromine-80 | Br-80 | 1,000 | | Bromine-82 | Br-82 | 100 | | Bromine-83 | Br-83 | 1,000 | | Bromine-84 | Br-84 | 1,000 | | Krypton-74 | Kr-74 | 1,000 | | Krypton-76 | Kr-76 | 1,000 | | Krypton-77 | Kr-77 | 1,000 | | Krypton-79 | Kr-79 | 1,000 | | Krypton-81 | Kr-81 | 1,000 | | Krypton-83m | Kr-83m | 1,000 | | Krypton-85m | Kr-85m | 1,000 | | Krypton-85 | Kr-85 | 1,000 | | Krypton-87 | Kr-87 | 1,000 | | Krypton-88 | Kr-88 | 1,000 | | Rubidium-79 | Rb-79 | 1,000 | | Rubidium-81m | Rb-81m | 1,000 | | Rubidium-81 | Rb-81 | 1,000 | | Rubidium-82m | Rb-82m | 1,000 | | Rubidium-83 | Rb-83 | 100 | | Rubidium-84 | Rb-84 | 100 | | Rubidium-86 | Rb-86 | 100 | | Rubidium-87 | Rb-87 | 100 | | Rubidium-88 | Rb-88 | 1,000 | | Rubidium-89 | Rb-89 | 1,000 | | Strontium-80 | Sr-80 | 100 | | Strontium-81 | Sr-81 | 1,000 | | Strontium-83 | Sr-83 | 100 | | Strontium-85m | Sr-85m | 1,000 | | Strontium-85 | Sr-85 | 100 | | Strontium-87m | Sr-87m | 1,000 | | Strontium-89 | Sr-89 | 10 | | Strontium-90 | Sr-90 | 0.1 | | Strontium-91 | Sr-91 | 100 | | Strontium-92 | Sr-92 | 100 | | Yttrium-86m | Y-86m | 1,000 | | Yttrium-86 | Y-86 | 100 | | Yttrium-87 | Y-87 | 100 | | Yttrium-88 | Y-88 | 10 | | Yttrium-90m | Y-90m | 1,000 | | Yttrium-90 | Y-90 | 10 | | Yttrium-91m | Y-91m | 1,000 | | Yttrium-91 | Y-91 | 10 | | Yttrium-92 | Y-92 | 100 | | Yttrium-93 | Y-93 | 100 | | Yttrium-94 | Y-94 | 1,000 | | Yttrium-95 | Y-95 | 1,000 | | Zirconium-86 | Zr-86 | 100 | | Zirconium-88 | Zr-88 | 10 | | Zirconium-89 | Zr-89 | 100 | | Zirconium-93 | Zr-93 | 1 | | Zirconium-95 | Zr-95 | 10 | | Zirconium-97 | Zr-97 | 100 | | Niobium-88 | Nb-88 | 1,000 | | Niobium-89m (66 min) | Nb-89m | 1,000 | | Niobium-89 (122 min) | Nb-89 | 1,000 | | Niobium-90 | Nb-90 | 100 | | Niobium-93m | Nb-93m | 10 | | Niobium-94 | Nb-94 | 1 | | Niobium-95m | Nb-95m | 100 | | Niobium-95 | Nb-95 | 100 | | Niobium-96 | Nb-96 | 100 | | Niobium-97 | Nb-97 | 1,000 | | Niobium-98 | Nb-98 | 1,000 | | Molybdenum-90 | Mo-90 | 100 | | Molybdenum-93m | Mo-93m | 100 | | Molybdenum-93 | Mo-93 | 10 | | Molybdenum-99 | Mo-99 | 100 | | Molybdenum-101 | Mo-101 | 1,000 | | Technetium-93m | Tc-93m | 1,000 | | Technetium-93 | Tc-93 | 1,000 | | Technetium-94m | Tc-94m | 1,000 | | Technetium-94 | Tc-94 | 1,000 | | Technetium-96m | Tc-96 | 1,000 | | Technetium-96 | Tc-96 | 100 | | Technetium-97m | Tc-97m | 100 | | Technetium-97 | Tc-97 | 1,000 | | Technetium-98 | Tc-98 | 10 | | Technetium-99m | Tc-99m | 1,000 | | Technetium-99 | Tc-99 | 100 | | Technetium-101 | Tc-101 | 1,000 | | Technetium-104 | Tc-104 | 1,000 | | Ruthenium-94 | Ru-94 | 1,000 | | Ruthenium-97 | Ru-97 | 1,000 | | Ruthenium-103 | Ru-103 | 100 | | Ruthenium-105 | Ru-105 | 1,000 | | Ruthenium-106 | Ru-106 | 1 | | Rhodium-99m | Rh-99m | 1,000 | | Rhodium-99 | Rh-99 | 100 | | Rhodium-100 | Rh-100 | 100 | | Rhodium-101m | Rh-101m | 1,000 | | Rhodium-101 | Rh-101 | 10 | | Rhodium-102m | Rh-102m | 10 | | Rhodium-102 | Rh-102 | 10 | | Rhodium-103m | Rh-103m | 1,000 | | Rhodium-105 | Rh-105 | 100 | | Rhodium-106m | Rh-106m | 1,000 | | Rhodium-107 | Rh-107 | 1,000 | | Palladium-100 | Pd-100 | 100 | | Palladium-101 | Pd-101 | 1,000 | | Palladium-103 | Pd-103 | 100 | | Palladium-107 | Pd-107 | 10 | | Palladium-109 | Pd-109 | 100 | | Silver-102 | Ag-102 | 1,000 | | Silver-103 | Ag-103 | 1,000 | | Silver-104m | Ag-104m | 1,000 | | Silver-104 | Ag-104 | 1,000 | | Silver-105 | Ag-105 | 100 | | Silver-106m | Ag-106m | 100 | | Silver-106 | Ag-106 | 1,000 | | Silver-108m | Ag-108m | 1 | | Silver-110m | Ag-110m | 10 | | Silver-111 | Ag-111 | 100 | | Silver-112 | Ag-112 | 100 | | Silver-115 | Ag-115 | 1,000 | | Cadmium-104 | Cd-104 | 1,000 | | Cadmium-107 | Cd-107 | 1,000 | | Cadmium-109 | Cd-109 | 1 | | Cadmium-113m | Cd-113m | 0.1 | | Cadmium-113 | Cd-113 | 100 | | Cadmium-115m | Cd-115m | 10 | | Cadmium-115 | Cd-115 | 100 | | Cadmium-117m | Cd-117m | 1,000 | | Cadmium-117 | Cd-117 | 1,000 | | Indium-109 | In-109 | 1,000 | | Indium-110 (69.1 min.) | In-110 | 1,000 | | Indium-110 (4.9h) | In-110 | 1,000 | | Indium-111 | In-111 | 100 | | Indium-112 | In-112 | 1,000 | | Indium-113m | In-113m | 1,000 | | Indium-114m | In-114m | 10 | | Indium-115m | In-115m | 1,000 | | Indium-115 | In-115 | 100 | | Indium-116m | In-116m | 1,000 | | Indium-117m | In-117m | 1,000 | | Indium-117 | In-117 | 1,000 | | Indium-119m | In-119m | 1,000 | | Tin-110 | Sn-110 | 100 | | Tin-111 | Sn-111 | 1,000 | | Tin-113 | Sn-113 | 100 | | Tin-117m | Sn-117m | 100 | | Tin-119m | Sn-119m | 100 | | Tin-121m | Sn-121m | 100 | | Tin-121 | Sn-121 | 1,000 | | Tin-123m | Sn-123m | 1,000 | | Tin-123 | Sn-123 | 10 | | Tin-125 | Sn-125 | 10 | | Tin-126 | Sn-126 | 10 | | Tin-127 | Sn-127 | 1,000 | | Tin-128 | Sn-128 | 1,000 | | Antimony-115 | Sb-115 | 1,000 | | Antimony-116m | Sb-116m | 1,000 | | Antimony-116 | Sb-116 | 1,000 | | Antimony-117 | Sb-117 | 1,000 | | Antimony-118m | Sb-118m | 1,000 | | Antimony-119 | Sb-119 | 1,000 | | Antimony-120 (16 min.) | Sb-120 | 1,000 | | Antimony-120 (5.76d) | Sb-120 | 100 | | Antimony-122 | Sb-122 | 100 | | Antimony-124m | Sb-124m | 1,000 | | Antimony-124 | Sb-124 | 10 | | Antimony-125 | Sb-125 | 100 | | Antimony-126m | Sb-126m | 1,000 | | Antimony-126 | Sb-126 | 100 | | Antimony-127 | Sb-127 | 100 | | Antimony-128 (10.4 min.) | Sb-128 | 1,000 | | Antimony-128 (9.01h) | Sb-128 | 100 | | Antimony-129 | Sb-129 | 100 | | Antimony-130 | Sb-130 | 1,000 | | Antimony-131 | Sb-131 | 1,000 | | Tellurium-116 | Te-116 | 1,000 | | Tellurium-121m | Te-121m | 10 | | Tellurium-121 | Te-121 | 100 | | Tellurium-123m | Te-123m | 10 | | Tellurium-123 | Te-123 | 100 | | Tellurium-125m | Te-125m | 10 | | Tellurium-127m | Te-127m | 10 | | Tellurium-127 | Te-127 | 1,000 | | Tellurium-129m | Te-129m | 10 | | Tellurium-129 | Te-129 | 1,000 | | Tellurium-131m | Te-131m | 10 | | Tellurium-131 | Te-131 | 100 | | Tellurium-132 | Te-132 | 10 | | Tellurium-133m | Te-133m | 100 | | Tellurium-133 | Te-133 | 1,000 | | Tellurium-134 | Te-134 | 1,000 | | Iodine-120m | I-120m | 1,000 | | Iodine-120 | I-120 | 100 | | Iodine-121 | I-121 | 1,000 | | Iodine-123 | I-123 | 100 | | Iodine-124 | I-124 | 10 | | Iodine-125 | I-125 | 1 | | Iodine-126 | I-126 | 1 | | Iodine-128 | I-128 | 1,000 | | Iodine-129 | I-129 | 1 | | Iodine-130 | I-130 | 10 | | Iodine-131 | I-131 | 1 | | Iodine-132m | I-132m | 100 | | Iodine-132 | I-132 | 100 | | Iodine-133 | I-133 | 10 | | Iodine-134 | I-134 | 1,000 | | Iodine-135 | I-135 | 100 | | Xenon-120 | Xe-120 | 1,000 | | Xenon-121 | Xe-121 | 1,000 | | Xenon-122 | Xe-122 | 1,000 | | Xenon-123 | Xe-123 | 1,000 | | Xenon-125 | Xe-125 | 1,000 | | Xenon-127 | Xe-127 | 1,000 | | Xenon-129m | Xe-129m | 1,000 | | Xenon-131m | Xe-131m | 1,000 | | Xenon-133m | Xe-133m | 1,000 | | Xenon-133 | Xe-133 | 1,000 | | Xenon-135m | Xe-135m | 1,000 | | Xenon-135 | Xe-135 | 1,000 | | Xenon-138 | Xe-138 | 1,000 | | Cesium-125 | Cs-125 | 1,000 | | Cesium-127 | Cs-127 | 1,000 | | Cesium-129 | Cs-129 | 1,000 | | Cesium-130 | Cs-130 | 1,000 | | Cesium-131 | Cs-131 | 1,000 | | Cesium-132 | Cs-132 | 100 | | Cesium-134m | Cs-134m | 1,000 | | Cesium-134 | Cs-134 | 10 | | Cesium-135m | Cs-135m | 1,000 | | Cesium-135 | Cs-135 | 100 | | Cesium-136 | Cs-136 | 10 | | Cesium-137 | Cs-137 | 10 | | Cesium-138 | Cs-138 | 1,000 | | Barium-126 | Ba-126 | 1,000 | | Barium-128 | B-128 | 100 | | Barium-131m | Ba-131m | 1,000 | | Barium-131 | Ba-131 | 100 | | Barium-133m | Ba-133m | 100 | | Barium-133 | Ba-133 | 100 | | Barium-135m | Ba-135m | 100 | | Barium-139 | Ba-139 | 1,000 | | Barium-140 | Ba-140 | 100 | | Barium-141 | Ba-141 | 1,000 | | Barium-142 | Ba-142 | 1,000 | | Lanthanum-131 | La-131 | 1,000 | | Lanthanum-132 | La-132 | 100 | | Lanthanum-135 | La-135 | 1,000 | | Lanthanum-137 | La-137 | 10 | | Lanthanum-138 | La-138 | 100 | | Lanthanum-140 | La-140 | 100 | | Lanthanum-141 | La-141 | 100 | | Lanthanum-142 | La-142 | 1,000 | | Lanthanum-143 | La-143 | 1,000 | | Cerium-134 | Ce-134 | 100 | | Cerium-135 | Ce-135 | 100 | | Cerium-137m | Ce-137m | 100 | | Cerium-137 | Ce-137 | 1,000 | | Cerium-139 | Ce-139 | 100 | | Cerium-141 | Ce-141 | 100 | | Cerium-143 | Ce-143 | 100 | | Cerium-144 | Ce-144 | 1 | | Praseodymium-136 | Pr-136 | 1,000 | | Praseodymium-137 | Pr-137 | 1,000 | | Praseodymium-138m | Pe-138m | 1,000 | | Praseodymium-139 | Pe-139 | 1,000 | | Praseodymium-142m | Pe-142m | 1,000 | | Praseodymium-142 | Pe-142 | 100 | | Praseodymium-143 | Pe-143 | 100 | | Praseodymium-144 | Pe-144 | 1,000 | | Praseodymium-145 | Pe-145 | 100 | | Praseodymium-147 | Pe-147 | 1,000 | | Neodymium-136 | Nd-136 | 1,000 | | Neodymium-138 | Nd-138 | 100 | | Neodymium-139m | Nd-139m | 1,000 | | Neodymium-139 | Nd-139 | 1,000 | | Neodymium-141 | Nd-141 | 1,000 | | Neodymium-147 | Nd-147 | 100 | | Neodymium-149 | Nd-149 | 1,000 | | Neodymium-151 | Nd-151 | 1,000 | | Promethium-141 | Pm-141 | 1,000 | | Promethium-143 | Pm-143 | 100 | | Promethium-144 | Pm-144 | 10 | | Promethium-145 | Pm-145 | 10 | | Promethium-146 | Pm-146 | 1 | | Promethium-147 | Pm-147 | 10 | | Promethium-148m | Pm-148m | 10 | | Promethium-148 | Pm-148 | 10 | | Promethium-149 | Pm-149 | 100 | | Promethium-150 | Pm-150 | 1,000 | | Promethium-151 | Pm-151 | 100 | | Samarium-141m | Sm-141m | 1,000 | | Samarium-141 | Sm-141 | 1,000 | | Samarium-142 | Sm-142 | 1,000 | | Samarium-145 | Sm-145 | 100 | | Samarium-146 | Sm-146 | 1 | | Samarium-147 | Sm-147 | 100 | | Samarium-151 | Sm-151 | 10 | | Samarium-153 | Sm-153 | 100 | | Samarium-155 | Sm-155 | 1,000 | | Samarium-156 | Sm-156 | 1,000 | | Europium-145 | Eu-145 | 100 | | Europium-146 | Eu-146 | 100 | | Europium-147 | Eu-147 | 100 | | Europium-148 | Eu-148 | 10 | | Europium-149 | Eu-149 | 100 | | Europium-150 (12.62h) | Eu-150 | 100 | | Europium-150 (34.2y) | Eu-150 | 1 | | Europium-152m | Eu-152m | 100 | | Europium-152 | Eu-152 | 1 | | Europium-154 | Eu-154 | 1 | | Europium-155 | Eu-155 | 10 | | Europium-156 | Eu-156 | 100 | | Europium-157 | Eu-157 | 100 | | Europium-158 | Eu-158 | 1,000 | | Gadolinium-145 | Gd-145 | 1,000 | | Gadolinium-146 | Gd-146 | 10 | | Gadolinium-147 | Gd-147 | 100 | | Gadolinium-148 | Gd-148 | 0.001 | | Gadolinium-149 | Gd-149 | 100 | | Gadolinium-151 | Gd-151 | 10 | | Gadolinium-152 | Gd-152 | 100 | | Gadolinium-153 | Gd-153 | 10 | | Gadolinium-159 | Gd-159 | 100 | | Terbium-147 | Tb-147 | 1,000 | | Terbium-149 | Tb-149 | 100 | | Terbium-150 | Tb-150 | 1,000 | | Terbium-151 | Tb-151 | 100 | | Terbium-153 | Tb-153 | 1,000 | | Terbium-154 | Tb-154 | 100 | | Terbium-155 | Tb-155 | 1,000 | | Terbium-156m (5.0h) | Tb-156m | 1,000 | | Terbium-156m (24.4h) | Tb-156m | 1,000 | | Terbium-156 | Tb-156 | 100 | | Terbium-157 | Tb-157 | 10 | | Terbium-158 | Tb-158 | 1 | | Terbium-160 | Tb-160 | 10 | | Terbium-161 | Tb-161 | 100 | | Dysprosium-155 | Dy-155 | 1,000 | | Dysprosium-157 | Dy-157 | 1,000 | | Dysprosium-159 | Dy-159 | 100 | | Dysprosium-165 | Dy-165 | 1,000 | | Dysprosium-166 | Dy-166 | 100 | | Holmium-155 | Ho-155 | 1,000 | | Holmium-157 | Ho-157 | 1,000 | | Holmium-159 | Ho-159 | 1,000 | | Holmium-161 | Ho-161 | 1,000 | | Holmium-162m | Ho-162m | 1,000 | | Holmium-162 | Ho-162 | 1,000 | | Holmium-164m | Hp-164m | 1,000 | | Holmium-164 | Ho-164 | 1,000 | | Holmium-166m | Ho-166m | 1 | | Holmium-166 | Ho-166 | 100 | | Holmium-167 | Ho-167 | 1,000 | | Erbium-161 | Er-161 | 1,000 | | Erbium-165 | Er-165 | 1,000 | | Erbium-169 | Er-169 | 100 | | Erbium-171 | Er-171 | 100 | | Erbium-172 | Er-172 | 100 | | Thulium-162 | Tm-162 | 1,000 | | Thulium-166 | Tm-166 | 100 | | Thulium-167 | Tm-167 | 100 | | Thulium-170 | Tm-170 | 10 | | Thulium-171 | Tm-171 | 10 | | Thulium-172 | Tm-172 | 100 | | Thulium-173 | Tm-173 | 100 | | Thulium-175 | Tm-175 | 1,000 | | Ytterbium-162 | Yb-162 | 1,000 | | Ytterbium-166 | Yb-166 | 100 | | Ytterbium-167 | Yb-167 | 1,000 | | Ytterbium-169 | Yb-169 | 100 | | Ytterbium-175 | Yb-175 | 100 | | Ytterbium-177 | Yb-177 | 1,000 | | Ytterbium-178 | Yb-178 | 1,000 | | Lutetium-169 | Lu-169 | 100 | | Lutetium-170 | Lu-170 | 100 | | Lutetium-171 | Lu-171 | 100 | | Lutetium-172 | Lu-172 | 100 | | Lutetium-173 | Lu-173 | 10 | | Lutetium-174m | Lu-174m | 10 | | Lutetium-174 | Lu-174 | 10 | | Lutetium-176m | Lu-176m | 1,000 | | Lutetium-176 | Lu-176 | 100 | | Lutetium-177m | Lu-177m | 10 | | Lutetium-177 | Lu-177 | 100 | | Lutetium-178m | Lu-178m | 1,000 | | Lutetium-178 | Lu-178 | 1,000 | | Lutetium-179 | Lu-179 | 1,000 | | Hafnium-170 | Hf-170 | 100 | | Hafnium-172 | Hf-172 | 1 | | Hafnium-173 | Hf-173 | 1,000 | | Hafnium-175 | Hf-175 | 100 | | Hafnium-177m | Hf-177m | 1,000 | | Hafnium-178m | Hf-178m | 0.1 | | Hafnium-179m | Hf-179m | 10 | | Hafnium-180m | Hf-180m | 1,000 | | Hafnium-181 | Hf-181 | 10 | | Hafnium-182m | Hf-182m | 1,000 | | Hafnium-182 | Hf-182 | 0.1 | | Hafnium-183 | Hf-183 | 1,000 | | Hafnium-184 | Hf-184 | 100 | | Tantalum-172 | Ta-172 | 1,000 | | Tantalum-173 | Ta-173 | 1,000 | | Tantalum-174 | Ta-174 | 1,000 | | Tantalum-175 | Ta-175 | 1,000 | | Tantalum-176 | Ta-176 | 100 | | Tantalum-177 | Ta-177 | 1,000 | | Tantalum-178 | Ta-178 | 1,000 | | Tantalum-179 | Ta-179 | 100 | | Tantalum-180m | Ta-180m | 1,000 | | Tantalum-180 | Ta-180 | 100 | | Tantalum-182m | Ta-182m | 1,000 | | Tantalum-182 | Ta-182 | 10 | | Tantalum-183 | Ta-183 | 100 | | Tantalum-184 | Ta-184 | 100 | | Tantalum-185 | Ta-185 | 1,000 | | Tantalum-186 | Ta-186 | 1,000 | | Tungsten-176 | W-176 | 1,000 | | Tungsten-177 | W-177 | 1,000 | | Tungsten-178 | W-178 | 1,000 | | Tungsten-179 | W-179 | 1,000 | | Tungsten-181 | W-181 | 1,000 | | Tungsten-185 | W-185 | 100 | | Tungsten-187 | W-187 | 100 | | Tungsten-188 | W-188 | 10 | | Rhenium-177 | Re-177 | 1,000 | | Rhenium-178 | Re-178 | 1,000 | | Rhenium-181 | Re-181 | 1,000 | | Rhenium-182 (12.7h) | Re-182 | 1,000 | | Rhenium-182 (64.0h) | Re-182 | 100 | | Rhenium-184m | Re-184m | 10 | | Rhenium-184 | Re-184 | 100 | | Rhenium-186m | Re-186m | 10 | | Rhenium-186 | Re-186 | 100 | | Rhenium-187 | Re-187 | 1,000 | | Rhenium-188m | Re-188m | 1,000 | | Rhenium-188 | Re-188 | 100 | | Rhenium-189 | Re-189 | 100 | | Osmium-180 | Os-180 | 1,000 | | Osmium-181 | Os-181 | 1,000 | | Osmium-182 | Os-182 | 100 | | Osmium-185 | Os-185 | 100 | | Osmium-189m | Os-189m | 1,000 | | Osmium-191m | Os-191m | 1,000 | | Osmium-191 | Os-191 | 100 | | Osmium-193 | Os-193 | 100 | | Osmium-194 | Os-194 | 1 | | Iridium-182 | Ir-182 | 1,000 | | Iridium-184 | Ir-184 | 1,000 | | Iridium-185 | Ir-185 | 1,000 | | Iridium-186 | Ir-186 | 100 | | Iridium-187 | Ir-187 | 1,000 | | Iridium-188 | Ir-188 | 100 | | Iridium-189 | Ir-189 | 100 | | Iridium-190m | Ir-190m | 1,000 | | Iridium-190 | Ir-190 | 100 | | Iridium-192 (73.8d) | Ir-192 | 1 | | Iridium-192m (1.4 min.) | Ir-192m | 10 | | Iridium-194m | Ir-194m | 10 | | Iridium-194 | Ir-194 | 100 | | Iridium-195m | Ir-195m | 1,000 | | Iridium-195 | Ir-95 | 1,000 | | Platinum-186 | Pt-186 | 1,000 | | Platinum-188 | Pt-188 | 100 | | Platinum-189 | Pt-189 | 1,000 | | Platinum-191 | Pt-191 | 100 | | Platinum-193m | Pt-193m | 100 | | Platinum-193 | Pt-193 | 1,000 | | Platinum-195m | Pt-195m | 100 | | Platinum-197m | Pt-197m | 1,000 | | Platinum-197 | Pt-197 | 100 | | Platinum-199 | Pt-199 | 1,000 | | Platinum-200 | Pt-200 | 100 | | Gold-193 | Au-193 | 1,000 | | Gold-194 | Au-194 | 100 | | Gold-195 | Au-195 | 10 | | Gold-198m | Au-198m | 100 | | Gold-198 | Au-198 | 100 | | Gold-199 | Au-199 | 100 | | Gold-200m | Au-200m | 100 | | Gold-200 | Au-200 | 1,000 | | Gold-201 | Au-201 | 1,000 | | Mercury-193m | Hg-193m | 100 | | Mercury-193 | Hg-193 | 1,000 | | Mercury-194 | Hg-194 | 1 | | Mercury-195m | Hg-195m | 100 | | Mercury-195 | Hg-195 | 1,000 | | Mercury-197m | Hg-197m | 100 | | Mercury-197 | Hg-197 | 1,000 | | Mercury-199m | Hg-199m | 1,000 | | Mercury-203 | Hg-203 | 100 | | Thallium-194m | Tl-194m | 1,000 | | Thallium-194 | Tl-194 | 1,000 | | Thallium-195 | Tl-195 | 1,000 | | Thallium-197 | Tl-197 | 1,000 | | Thallium-198m | Tl-198m | 1,000 | | Thallium-198 | Tl-198 | 1,000 | | Thallium-199 | Tl-199 | 1,000 | | Thallium-200 | Tl-200 | 1,000 | | Thallium-201 | Tl-201 | 1,000 | | Thallium-202 | Tl-202 | 100 | | Thallium-204 | Tl-204 | 100 | | Lead-195m | Pb-195m | 1,000 | | Lead-198 | Pb-198 | 1,000 | | Lead-199 | Pb-199 | 1,000 | | Lead-200 | Pb-200 | 100 | | Lead-201 | Pb-201 | 1,000 | | Lead-202m | Pb-202m | 1,000 | | Lead-202 | Pb-202 | 10 | | Lead-203 | Pb-203 | 1,000 | | Lead-205 | Pb-205 | 100 | | Lead-209 | Pb-209 | 1,000 | | Lead-210 | Pb-210 | 0.01 | | Lead-211 | Pb-211 | 100 | | Lead-212 | Pb-212 | 1 | | Lead-214 | Pb-214 | 100 | | Bismuth-200 | Bi-200 | 1,000 | | Bismuth-201 | Bi-201 | 1,000 | | Bismuth-202 | Bi-202 | 1,000 | | Bismuth-203 | Bi-203 | 100 | | Bismuth-205 | Bi-205 | 100 | | Bismuth-206 | Bi-206 | 100 | | Bismuth-207 | Bi-207 | 10 | | Bismuth-210m | Bi-210m | 0.1 | | Bismuth-210 | Bi-210 | 1 | | Bismuth-212 | Bi-212 | 10 | | Bismuth-213 | Bi-213 | 10 | | Bismuth-214 | Bi-214 | 100 | | Polonium-203 | Po-203 | 1,000 | | Polonium-205 | Po-205 | 1,000 | | Polonium-207 | Po-207 | 1,000 | | Polonium-210 | Po-210 | 0.1 | | Astatine-207 | At-207 | 100 | | Astatine-211 | At-211 | 10 | | Radon-220 | Rn-220 | 1 | | Radon-222 | Rn-222 | 1 | | Francium-222 | Fr-222 | 100 | | Francium-223 | Fr-223 | 100 | | Radium-223 | Ra-223 | 0.1 | | Radium-224 | Ra-224 | 0.1 | | Radium-225 | Ra-225 | 0.1 | | Radium-226 | Ra-226 | 0.1 | | Radium-227 | Ra-227 | 1,000 | | Radium-228 | Ra-228 | 0.1 | | Actinium-224 | Ac-224 | 1 | | Actinium-225 | Ac-225 | 0.01 | | Actinium-226 | Ac-226 | 0.1 | | Actinium-227 | Ac-227 | 0.001 | | Actinium-228 | Ac-228 | 1 | | Thorium-226 | Th-226 | 10 | | Thorium-227 | Th-227 | 0.01 | | Thorium-228 | Th-228 | 0.001 | | Thorium-229 | Th-229 | 0.001 | | Thorium-230 | Th-230 | 0.001 | | Thorium-231 | Th-231 | 100 | | Thorium-232 | Th-232 | 100 | | Thorium-234 | Th-234 | 10 | | Thorium-natural | | 100 | | Protactinium-227 | Pa-227 | 10 | | Protactinium-228 | Pa-228 | 1 | | Protactinium-230 | Pa-230 | 0.1 | | Protactinium-231 | Pa-231 | 0.001 | | Protactinium-232 | Pa-232 | 1 | | Protactinium-233 | Pa-233 | 100 | | Protactinium-234 | Pa-234 | 100 | | Uranium-230 | U-230 | 0.01 | | Uranium-231 | U-231 | 100 | | Uranium-232 | U-232 | 0.001 | | Uranium-233 | U-233 | 0.001 | | Uranium-234 | U-234 | 0.001 | | Uranium-235 | U-235 | 0.001 | | Uranium-236 | U-236 | 0.001 | | Uranium-237 | U-237 | 100 | | Uranium-238 | U-238 | 100 | | Uranium-239 | U-239 | 1,000 | | Uranium-240 | U-240 | 100 | | Uranium-natural | | 100 | | Neptunium-232 | Np-232 | 100 | | Neptunium-233 | Np-233 | 1,000 | | Neptunium-234 | Np-234 | 100 | | Neptunium-235 | Np-235 | 100 | | Neptunium-236 (1.15x10⁵y) | Np-236 | 0.001 | | Neptunium-236 (22.5h) | Np-236 | 1 | | Neptunium-237 | Np-237 | 0.001 | | Neptunium-238 | Np-238 | 10 | | Neptunium-239 | Np-239 | 100 | | Neptunium-240 | Np-240 | 1,000 | | Plutonium-234 | Pu-234 | 10 | | Plutonium-235 | Pu-235 | 1,000 | | Plutonium-236 | Pu-236 | 0.001 | | Plutonium-237 | Pu-237 | 100 | | Plutonium-238 | Pu-238 | 0.001 | | Plutonium-239 | Pu-239 | 0.001 | | Plutonium-240 | Pu-240 | 0.001 | | Plutonium-241 | Pu-241 | 0.01 | | Plutonium-242 | Pu-242 | 0.001 | | Plutonium-243 | Pu-243 | 1,000 | | Plutonium-244 | Pu-244 | 0.001 | | Plutonium-245 | Pu-245 | 100 | | Americium-237 | Am-237 | 1,000 | | Americium-238 | Am-238 | 100 | | Americium-239 | Am-239 | 1,000 | | Americium-240 | Am-240 | 100 | | Americium-241 | Am-241 | 0.001 | | Americium-242m | Am-242m | 0.001 | | Americium-242 | Am-242 | 10 | | Americium-243 | Am-243 | 0.001 | | Americium-244m | Am-244m | 100 | | Americium-244 | Am-244 | 10 | | Americium-245 | Am-245 | 1,000 | | Americium-246m | Am-246m | 1,000 | | Americium-246 | Am-246 | 1,000 | | Curium-238 | Cm-238 | 100 | | Curium-240 | Cm-240 | 0.1 | | Curium-241 | Cm-241 | 1 | | Curium-242 | Cm-242 | 0.01 | | Curium-243 | Cm-243 | 0.001 | | Curium-244 | Cm-244 | 0.001 | | Curium-245 | Cm-245 | 0.001 | | Curium-246 | Cm-246 | 0.001 | | Curium-247 | Cm-247 | 0.001 | | Curium-248 | Cm-248 | 0.001 | | Curium-249 | Cm-249 | 1,000 | | Berkelium-245 | Bk-245 | 100 | | Berkelium-246 | Bk-246 | 100 | | Berkelium-247 | Bk-247 | 0.001 | | Berkelium-249 | Bk-249 | 0.1 | | Berkelium-250 | Bk-250 | 10 | | Californium-244 | Cf-244 | 100 | | Californium-246 | Cf-246 | 1 | | Californium-248 | Cf-248 | 0.01 | | Californium-249 | Cf-249 | 0.001 | | Californium-250 | Cf-250 | 0.001 | | Californium-251 | Cf-251 | 0.001 | | Californium-252 | Cf-252 | 0.001 | | Californium-253 | Cf-253 | 0.1 | | Californium-254 | Cf-254 | 0.001 | | Einsteinium-250 | Es-250 | 100 | | Einsteinium-251 | Es-251 | 100 | | Einsteinium-253 | Es-253 | 0.1 | | Einsteinium-254m | Es-254m | 1 | | Einsteinium-254 | Es-254 | 0.01 | | Fermium-252 | Fm-252 | 1 | | Fermium-253 | Fm-253 | 1 | | Fermium-254 | Fm-254 | 10 | | Fermium-255 | Fm-255 | 1 | | Fermium-257 | Fm-257 | 0.01 | | Mendelevium-257 | Md-257 | 10 | | Mendelevium-258 | Md-258 | 0.01 | | Any radionuclide other than alpha emitter radionuclides not listed above, or mixtures of beta emitters of unknown composition | | 0.01 | | Any alpha-emitting radionuclide not listed above or mixtures of alpha-emitters of unknown composition | | 0.001 | | ¹The quantities listed above were derived by taking 1/10 of the most restrictive ALI listed in table 1, columns 1 and 2 of 10 CFR Part 20, Appendix B, rounding to the nearest factor of 10, and arbitrarily constraining the values listed between 0.001 and 1,000 μCi. Values of 100 μCi have been assigned for radionuclides having a radioactive half-life in excess of 10⁹ years (except rhenium, 1000 μCi) to take into account their low specific activity. | | |

NOTE: For purposes of 10 CFR 20.1902(e), 10 CFR 20.1905(a), and 10 CFR 20.2201(a) where there is involved a combination of radionuclides in known amounts, the limit for the combination should be derived as follows: determine, for each radionuclide in the combination, the ratio between the quantity present in the combination and the limit otherwise established for the specific radionuclide when not in combination. The sum of such ratios for all radionuclides in the combination may not exceed "1" (i.e., "unity").

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3710 Requirements for transfers of low-level radioactive waste intended for disposal at licensed land disposal facilities and manifests

A. Manifest.

1. A waste generator, waste collector, or waste processor that transports, or offers for transportation, low-level radioactive waste intended for ultimate disposal at a licensed low-level radioactive waste land disposal facility must prepare a manifest reflecting information requested on applicable NRC Forms 540 (Uniform Low-Level Radioactive Waste Manifest (Shipping Paper)) and 541 (Uniform Low-Level Radioactive Waste Manifest (Container and Waste Description)) and, if necessary, on an applicable NRC Form 542 (Uniform Low-Level Radioactive Waste Manifest (Manifest Index and Regional Compact Tabulation)). NRC Forms 540 and 540A must be completed and must physically accompany the pertinent low-level waste shipment.

2. Upon agreement between shipper and consignee, NRC Forms 541, 541A, 542, and 542A may be completed, transmitted, and stored in electronic media with the capability for producing legible, accurate, and complete records on the respective forms.

3. Licensees are not required by the agency, the NRC, or another agreement state to comply with the manifesting requirements of this subpart when they ship:

a. Low-level radioactive waste for processing and expect its return, such as for storage under their license, prior to disposal at a licensed land disposal facility;

b. Low-level radioactive waste that is being returned to the licensee that is the waste generator or generator; or

c. Radioactively contaminated material to a waste processor that becomes the processor's residual waste.

4. For guidance in completing the forms required under subdivision 1 of this subsection, refer to the instructions that accompany the forms. Copies of manifests required by this subpart may be legible carbon copies, photocopies, or computer printouts that reproduce the data in the format of the uniform manifest.

5. NRC Forms 540, 540A, 541, 541A, 542, and 542A, and the accompanying instructions, in hard copy, may be obtained by writing or calling the Office of Information Services, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (800) 368-5642, or by visiting the NRC's website at www.nrc.gov.

6. This section includes information requirements of the DOT, as codified in 49 CFR Part 172. Information on hazardous, medical, or other waste, required to meet Environmental Protection Agency (EPA) regulations, as codified in 40 CFR Part 259, 261 or elsewhere, is not addressed in this section and must be provided on the required EPA forms. However, the required EPA forms must accompany the uniform low-level radioactive waste manifest required by this section.

B. General information. The shipper of the radioactive waste must provide the following information on the uniform manifest:

1. The name, facility address, and telephone number of the licensee shipping the waste;

2. An explicit declaration indicating whether the shipper is acting as a waste generator, waste collector, waste processor, or a combination of these identifiers for purposes of the manifested shipment; and

3. The name, address, and telephone number, or the name and EPA identification number for the carrier transporting the waste.

C. Shipment information. The shipper of the radioactive waste must provide the following information regarding the waste shipment on the uniform manifest:

1. The date of the waste shipment;

2. The total number of packages or disposal containers;

3. The total disposal volume and disposal weight in the shipment;

4. The total radionuclide activity in the shipment;

5. The activity of each of the radionuclides H-3, C-14, Tc-99, and I-129 contained in the shipment; and

6. The total masses of U-233, U-235, and plutonium in special nuclear material and the total mass of uranium and thorium in source material.

D. Disposal container and waste information. The shipper of the radioactive waste must provide the following information on the uniform manifest regarding the waste and each disposal container of waste in the shipment:

1. An alphabetic or numeric identification that uniquely identifies each disposal container in the shipment;

2. A physical description of the disposal container, including the manufacturer and model of any high integrity container;

3. The volume displaced by the disposal container;

4. The gross weight of the disposal container, including the waste;

5. For waste consigned to a disposal facility, the maximum radiation level at the surface of each disposal container;

6. A physical and chemical description of the waste;

7. The total weight percentage of chelating agent for any waste containing more than 0.1% chelating agent by weight, plus the identity of the principal chelating agent;

8. The approximate volume of waste within a container;

9. The sorbing or solidification media, if any, and the identity of the solidification media vendor and brand name;

10. The identities and activities of individual radionuclides contained in each container, the masses of U-233, U-235, and plutonium in special nuclear material, and the masses of uranium and thorium in source material. For discrete waste types, such as activated materials, contaminated equipment, mechanical filters, sealed source or devices, and wastes in solidification or stabilization media, the identities and activities of individual radionuclides associated with or contained on these waste types within a disposal container must be reported; and

11. The total radioactivity within each container.

E. Uncontainerized waste information. The shipper of the radioactive waste must provide the following information on the uniform manifest regarding a waste shipment delivered without a disposal container:

1. The approximate volume and weight of the waste;

2. A physical and chemical description of the waste;

3. The total weight percentage of chelating agent if the chelating agent exceeds 0.1% by weight, plus the identity of the principal chelating agent;

4. For waste consigned to a disposal facility, the classification of the waste according to 12VAC5-481-2571. Waste not meeting the structural stability requirements of 12VAC5-481-2572 must be identified;

5. The identities and activities of individual radionuclides contained in the waste, the masses of U-233, U-235, and plutonium in special nuclear material, and the masses of uranium and thorium in source material; and

6. For wastes consigned to a disposal facility, the maximum radiation levels at the surface of the waste.

F. Multigenerator disposal container information.

1. This subsection applies to disposal containers enclosing mixtures of waste originating from different generators. The origin of the low-level radioactive waste resulting from a waste processor's activities may be attributable to one or more generators, including waste generators. This subsection also applies to mixtures of wastes shipped in an uncontainerized form, for which portions of the mixture within the shipment originate from different generators.

2. For homogeneous mixtures of waste, such as incinerator ash, the shipper must provide the waste description applicable to the mixture and the volume of the waste attributed to each generator.

3. For heterogeneous mixtures of waste, such as the combined products from a large compactor, the shipper must identify each generator contributing waste to the disposal container and for discrete waste types, such as activated materials, contaminated equipment, mechanical filters, sealed source or devices, and wastes in solidification or stabilization media, the identities and activities of individual radionuclides contained on these waste types within the disposal container. For each generator, the shipper must provide the following:

a. The volume of waste within the disposal container;

b. A physical and chemical description of the waste, including the solidification agent, if any;

c. The total weight percentage of chelating agents for any disposal container containing more than 0.1 percent chelating agent by weight, plus the identity of the principal chelating agent;

d. The sorbing or solidification media, if any, and the identity of the solidification media vendor and brand name if the media is claimed to meet stability requirements in 12VAC5-481-2572; and

e. Radionuclide identities and activities contained in the waste, the masses of U-233, U-235, and plutonium in special nuclear material, and the masses of uranium and thorium in source material, if contained in the waste.

G. Certification. An authorized representative of the waste generator, waste processor, or waste collector must certify by signing and dating the shipment manifest that the transported materials are properly classified, described, packaged, marked, and labeled and are in proper condition for transportation according to the applicable regulations of the DOT and the agency, NRC or another agreement state. A waste collector, in signing the certification, is certifying that nothing has been done to the collected waste that would invalidate the waste generator's certification.

H. Control and tracking; transfers. A licensee that transfers radioactive waste to a land disposal facility or a licensed waste collector must comply with subdivisions 1 through 9 of this subsection. A licensee that transfers waste to a licensed waste processor for waste treatment or repackaging must comply with subdivisions 4 through 9 of this subsection. A licensee shall:

1. Prepare all wastes so that the waste is classified according to 12VAC5-481-2571, and meets the waste characteristics requirements in 12VAC5-481-2572;

2. Label each disposal container of waste, or transport package if potential radiation hazards preclude labeling of the individual disposal container, to identify whether it is Class A waste, Class B waste, Class C waste, or greater than Class C waste, according to 12VAC5-481-2571;

3. Conduct a quality assurance program to ensure compliance with 12VAC5-481-2571 and 12VAC5-481-2572. The program must include management evaluation of audits;

4. Prepare the uniform low-level radioactive waste manifest as required by this part;

5. Forward a copy or electronically transfer the uniform low-level radioactive waste manifest to the intended consignee so that receipt of the manifest precedes the low-level radioactive waste shipment or the manifest is delivered to the consignee with the waste at the time the waste is transferred to the consignee, or both;

6. Include NRC Form 540, and Form 540A if required, with the shipment regardless of the option chosen in subdivision 5 of this subsection;

7. Receive acknowledgment of the receipt of the shipment in the form of a signed copy of NRC Form 540;

8. Retain a copy of or electronically store the uniform low-level radioactive waste manifest and documentation of acknowledgment of receipt as the record of transfer of licensed material as required by Part I (12VAC5-481-10 et seq.), Part III (12VAC5-481-380 et seq.), Part IV (12VAC5-481-600 et seq.) and Part X (12VAC5-481-2250 et seq.); and

9. For any shipment or any part of a shipment for which acknowledgment of receipt has not been received within the times set forth in this part, conduct an investigation according to subsection L of this section.

I. Control and tracking; prepackaged waste. A waste collector licensee that handles only prepackaged waste must:

1. Acknowledge receipt of the waste from the shipper within one week of receipt by returning a signed copy of NRC Form 540;

2. Prepare a new manifest to reflect consolidated shipments that meet the requirements of this section. The waste collector must ensure that, for each container of waste in the shipment, the manifest identifies the generator of that container of waste;

3. Forward a copy or electronically transfer the uniform low-level radioactive waste manifest to the intended consignee so that receipt of the manifest precedes the low-level radioactive waste shipment or the manifest is delivered to the consignee with the waste at the time the waste is transferred to the consignee, or both;

4. Include NRC Form 540, and 540A if required, with the shipment regardless of the option chosen in subdivision 4 of this subsection;

5. Receive acknowledgment of the receipt of the shipment in the form of a signed copy of NRC Form 540;

6. Retain a copy of or electronically store the uniform low-level radioactive waste manifest and documentation of acknowledgment of receipt as the record of transfer of licensed material as required under Part I (12VAC5-481-10 et seq.), Part III (12VAC5-481-380 et seq.), Part IV (12VAC5-481-600 et seq.) and Part X (12VAC5-481-2250 et seq.);

7. For any shipment or any part of a shipment for which acknowledgment of receipt has not been received within the times set forth in this section, conduct an investigation according to subsection L of this section; and

8. Notify the shipper and the agency when any shipment, or part of a shipment, has not arrived within 60 days after receipt of an advance manifest, unless notified by the shipper that the shipment has been canceled.

J. Control and tracking; treatment or repackaging. A licensed waste processor that treats or repackages waste must:

1. Acknowledge receipt of the waste from the shipper within one week of receipt by returning a signed copy of NRC Form 540;

2. Prepare a new manifest that meets the requirements of this section. Preparation of the new manifest reflects that the waste processor is responsible for meeting these requirements. For each container of waste in the shipment, the manifest must identify the waste generators, the preprocessed waste volume, and the other information as required under subsection F of this section;

3. Prepare all wastes so that the waste is classified according to 12VAC5-481-2571, and meets the waste characteristics requirements in 12VAC5-481-2572;

4. Label each package of waste to identify whether it is Class A waste, Class B waste, or Class C waste, in accordance with 12VAC5-481-2571 and 12VAC5-481-2572;

5. Conduct a quality assurance program to ensure compliance with 12VAC5-481-2571 and 12VAC5-481-2572. The program must include management evaluation of audits;

6. Forward a copy or electronically transfer the uniform low-level radioactive waste manifest to the intended consignee so that receipt of the manifest precedes the low-level radioactive waste shipment or the manifest is delivered to the consignee with the waste at the time the waste is transferred to the consignee, or both;

7. Include NRC Form 540, and Form 540A if required, with the shipment regardless of the option chosen in subdivision 6 of this subsection;

8. Receive acknowledgment of the receipt of the shipment in the form of a signed copy of NRC Form 540;

9. Retain a copy of or electronically store the uniform low-level radioactive waste manifest and documentation of acknowledgment of receipt as the record of transfer of licensed material as required by Part I (12VAC5-481-10 et seq.), Part III (12VAC5-481-380 et seq.), Part IV (12VAC5-481-600 et seq.) and Part X (12VAC5-481-2250 et seq.);

10. For any shipment or any part of a shipment for which acknowledgment of receipt has not been received within the times set forth in this part, conduct an investigation according to subsection L; and

11. Notify the shipper and the agency when any shipment, or part of a shipment, has not arrived within 60 days after receipt of an advance manifest, unless notified by the shipper that the shipment has been canceled.

K. Control and tracking; land disposal facility. A land disposal facility operator shall:

1. Acknowledge receipt of the waste within one week of receipt by returning, as a minimum, a signed copy of NRC Form 540 to the shipper. The shipper to be notified is the licensee that last possessed the waste and transferred the waste to the operator. If any discrepancy exists between materials listed on the uniform low-level radioactive waste manifest and materials received, copies or electronic transfer of the affected forms must be returned indicating the discrepancy;

2. Maintain copies of all completed manifests and electronically store the information required by 12VAC5-481-2630, until the agency terminates the license; and

3. Notify the shipper and the agency when any shipment, or part of a shipment, has not arrived within 60 days after receipt of an advance manifest, unless notified by the shipper that the shipment has been canceled.

L. Investigation. A shipment or part of a shipment for which acknowledgment is not received within the times set forth in this part must:

1. Be investigated by the shipper if the shipper has not received notification or receipt within 20 days after transfer; and

2. Be traced and reported. The investigation must include tracing the shipment and filing a report with the agency. A licensee that conducts a trace investigation must file a written report with the agency within two weeks of completing the investigation.

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008; amended, Virginia Register Volume 25, Issue 2, eff. November 1, 2008.

12VAC5-481-3720 Exempt concentrations schedule

| Element (atomic number) | Isotope | Col. I | Col. II | | --- | --- | --- | --- | | Gas Concentration μCi/ml¹ | Liquid and Solid Concentration μCi/ml² | | | | Antimony (51) | Sb-122 | | 3 x 10^-4 | | Sb-124 | 2 x 10^-4 | | | | Sb-125 | 1 x 10^-3 | | | | Argon (18) | A-37 | 1 x 10^-3 | | | A-41 | 4 x 10^-7 | | | | Arsenic (33) | As-73 | | 5 x 10^-3 | | As-74 | 5 x 10^-4 | | | | As-76 | 2 x 10^-4 | | | | As-77 | 8 x 10^-4 | | | | Barium (56) | Ba-131 | | 2 x 10^-3 | | Ba-140 | 3 x 10^-4 | | | | Beryllium (4) | Be-7 | | 2 x 10^-2 | | Bismuth (83) | Bi-206 | | 4 x 10^-4 | | Bromine (35) | Br-82 | 4 x 10^-7 | 3 x 10^-3 | | Cadmium (48) | Cd-109 | | 2 x 10^-3 | | Cd-115M | 3 x 10^-4 | | | | Cd-115 | 3 x 10^-4 | | | | Calcium (20) | Ca-45 | | 9 x 10^-5 | | Ca-47 | 5 x 10^-4 | | | | Carbon (6) | C-14 | 1 x 10^-6 | 8 x 10^-3 | | Cerium (58) | Ce-141 | | 9 x 10^-4 | | Ce-143 | 4 x 10^-4 | | | | Ce-144 | 1 x 10^-4 | | | | Cesium (55) | Cs-131 | | 2 x 10^-2 | | Cs-134m | 6 x 10^-2 | | | | Cs-134 | 9 x 10^-5 | | | | Chlorine (17) | Cl-38 | 9 x 10^-7 | 4 x 10^-3 | | Chromium (24) | Cr-51 | | 2 x 10^-2 | | Cobalt (27) | Co-57 | | 5 x 10^-3 | | Co-58 | 1 x 10^-3 | | | | Co-60 | 5 x 10^-4 | | | | Copper (29) | Cu-64 | | 3 x 10^-3 | | Dysprosium (66) | Dy-165 | | 4 x 10^-3 | | Dy-166 | 4 x 10^-4 | | | | Erbium (68) | Er-169 | | 9 x 10^-4 | | Er-171 | 1 x 10^-3 | | | | Europium (63) | Eu-152 (9.2 hrs) | | 6 x 10^-4 | | Eu-155 | 2 x 10^-3 | | | | Fluorine (9) | F-18 | 2 x 10^-6 | 8 x 10^-3 | | Gadolinium (64) | Gd-153 | | 2 x 10^-3 | | Gd-159 | 8 x `0^-4 | | | | Gallium (31) | Ga-72 | | 4 x 10^-4 | | Germanium (32) | Ge-71 | | 2 x 10^-2 | | Gold (79) | Au-196 | | 2 x 10^-3 | | Au-198 | 5 x 10^-4 | | | | Au-199 | 2 x 10^-3 | | | | Hafnium (72) | Hf-81 | | 7 x 10^-4 | | Hydrogen (1) | H-3 | 5 x 10^-6 | 3 x 10^-2 | | Indium (49) | In-113M | | 1 x 10^-2 | | In-114M | 2 x 10^-4 | | | | Iodine (53) | I-126 | 3 x 10^-9 | 2 x 10^-5 | | I-131 | 3 x 10^-9 | 2 x 10^-5 | | | I-132 | 8 x 10^-8 | 6 x 10^-4 | | | I-133 | 1 x 10^-8 | 7 x 10^-5 | | | I-134 | 2 x 10^-7 | 1 x 10^-3 | | | Iridium (77) | Ir-190 | | 2 x 10^-3 | | Ir-192 | 4 x 10^-4 | | | | Ir-194 | 3 x 10^-4 | | | | Iron (26) | Fe-55 | | 8 x 10^-3 | | Fe-59 | 6 x 10^-4 | | | | Krypton (36) | Kr-85M | 1 x 10^-6 | | | Kr-85 | 3 x 10^-6 | | | | Lanthanum (57) | La-140 | | 2 x 10^-4 | | Lead (82) | Pb-203 | | 4 x 10^-3 | | Lutetium (71) | Lu-177 | | 1 x 10^-3 | | Manganese (25) | Mn-52 | | 3 x 10^-4 | | Mn-54 | 1 x 10^-3 | | | | Mn-56 | 1 x 10^-3 | | | | Mercury (80) | Hg-197M | | 2 x 10^-3 | | Hg-197 | 3 x 10^-3 | | | | Hg-203 | 2 x 10^-4 | | | | Molybdenum (42) | Mo-99 | | 2 x 10^-3 | | Neodymium (60) | Nd-147 | | 6 x 10^-4 | | Nd-149 | 3 x 10^-3 | | | | Nickel (28) | Ni-65 | | 1 x 10^-3 | | Niobium (Columbium) (41) | Nb-95 | | 1 x 10^-3 | | Nb-97 | 9 x 10^-3 | | | | Osmium (76) | Os-185 | | 7 x 10^-4 | | Os-191M | 3 x 10^-2 | | | | Os-191 | 2 x 10^-3 | | | | Os-193 | 6 x 10^-4 | | | | Palladium (46) | Pd-103 | | 3 x 10^-3 | | Pd-109 | 9 x 10^-4 | | | | Phosphorus (15) | P-32 | | 2 x 10^-4 | | Platinum (78) | Pt-191 | | 1 x 10^-3 | | Pt-193M | 1 x 10^-2 | | | | Pt-197M | 1 x 10^-2 | | | | Pt-197 | 1 x 10^-3 | | | | Potassium (19) | K-42 | | 3 x 10^-3 | | Praseodymium (59) | Pr-142 | | 3 x 10^-4 | | Pr-143 | 5 x 10^-4 | | | | Promethium (61) | Pm-147 | | 2 x 10^-3 | | Pm-149 | 4 x 10^-4 | | | | Rhenium (75) | Re-183 | | 6 x 10^-3 | | Re-186 | 9 x 10^-4 | | | | Re-188 | 6 x 10^-4 | | | | Rhodium (45) | Rh-103M | | 1 x 10^-1 | | Rh-105 | 1 x 10^-3 | | | | Rubidium (37) | Rb-86 | | 7 x 10^-4 | | Ruthenium (44) | Ru-97 | | 4 x 10^-4 | | Ru-103 | 8 x 10^-4 | | | | Ru-105 | 1 x 10^-3 | | | | Ru-106 | 1 x 10^-4 | | | | Samarium (62) | Sm-153 | | 8 x 10^-4 | | Scandium (21) | Sc-46 | | 4 x 10^-4 | | Sc-47 | 9 x 10^-4 | | | | Sc-48 | 3 x 10^-4 | | | | Selenium (34) | Se-75 | | 3 x 10^-3 | | Silicon (14) | Si-31 | | 9 x 10^-3 | | Silver (47) | Ag-105 | | 1 x 10^-3 | | Ag-110M | 3 x 10^-4 | | | | Ag-111 | 4 x 10^-4 | | | | Sodium (11) | Na-24 | | 2 x 10^-3 | | Strontium (38) | Sr-85 | | 1 x 10^-4 | | Sr-89 | 1 x 10^-4 | | | | Sr-91 | 7 x 10^-4 | | | | Sr-92 | 7 x 10^-4 | | | | Sulfur (16) | S-35 | 9 x 10^-8 | 6 x 10^-4 | | Tantalum (73) | Ta-182 | | 4 x 10^-4 | | Technetium (43) | Tc-96M | | 1 x 10^-1 | | Tc-96 | 1 x 10^-3 | | | | Tellurium (52) | Te-125M | | 2 x 10^-3 | | Te-125M | 6 x 10^-4 | | | | Te-127 | 3 x 10^-3 | | | | Te-129M | 3 x 10^-4 | | | | Te-131M | 6 x 10^-4 | | | | Te-132 | 3 x 10^-4 | | | | Terbium (65) | Tb-160 | | 4 x 10^-4 | | Thallium (81) | Tl-200 | | 4 x 10^-3 | | Tl-201 | 3 x 10^-3 | | | | Tl-202 | 1 x 10^-3 | | | | Tl-204 | 1 x 10^-3 | | | | Thulium (69) | Tm-170 | | 5 x 10^-4 | | Tm-171 | 5 x 10^-3 | | | | Tin (50) | Sn-113 | | 9 x 10^-4 | | Sn-125 | 2 x 10^-4 | | | | Tungsten (Wolfram) (74) | W-181 | | 4 x 10^-3 | | W-187 | 7 x 10^-4 | | | | Vanadium (23) | V-48 | | 3 x 10^-4 | | Xenon (54) | Xe-131M | 4 x 10^-6 | | | Xe-133 | 3 x 10^-6 | | | | Xe-135 | 1 x 10^-6 | | | | Ytterbium (70) | Yb-175 | | 1 x 10^-3 | | Yttrium (39) | Y-90 | | 2 x 10^-4 | | Y-91M | 3 x 10^-2 | | | | Y-91 | 3 x 10^-4 | | | | Y-92 | 6 x 10^-4 | | | | Y-93 | 3 x 10^-4 | | | | Zinc (30) | Zn-65 | | 1 x 10^-3 | | Zn-69M | 7 x 10^-4 | | | | Zn-69 | 2 x 10^-2 | | | | Zirconium (40) | Zr-95 | | 6 x 10^-4 | | Zr-97 | 2 x 10^-4 | | | | Beta and/or gamma emitting radioactive material not listed above with half-life less than three years | | 1 x 10^-10 | 1 x 10^-6 | | Footnotes: ¹Values are given only for those materials normally used as gases. ²μCi/gm for solids. | | | |

NOTE 1: Many radioisotopes disintegrate into isotopes that are also radioactive. In expressing the concentrations, the activity stated is that of the parent isotope and takes into account the daughters.

NOTE 2: For purposes of 12VAC5-481-400 A where there is involved a combination of isotopes, the limit for the combination should be derived as follows:

Determine for each isotope in the product the ratio between the concentration present in the product and the exempt concentration for the specific isotope when not in combination. The sum of such ratios may not exceed "1" (i.e., unity).

Example:

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3730 Exempt quantities

| Radioactive material | Microcuries | | --- | --- | | Antimony 122 (Sb 122) | 100 | | Antimony 124 (Sb 124) | 10 | | Antimony 125 (Sb 125) | 10 | | Arsenic 73 (As 73) | 100 | | Arsenic 74 (As 74) | 10 | | Arsenic 76 (As 76) | 10 | | Arsenic 77 (as 77) | 100 | | Barium 131 (Ba 131) | 10 | | Barium 133 (Ba 133) | 10 | | Barium 140 (Ba 140) | 10 | | Bismuth 210 (Bi 210) | 1 | | Bromine 82 (Br 82) | 10 | | Cadmium109 (Cd 109) | 10 | | Cadmium 115m (Cd 115m) | 10 | | Cadmium115 (Cd 115) | 100 | | Calcium 45 (Ca 45) | 10 | | Calcium 47 (Ca 47) | 10 | | Carbon 14 (C 14) | 100 | | Cerium 141 (Ce 141) | 100 | | Cerium 143 (Ce 143) | 100 | | Cerium 144 (Ce 144) | 1 | | Cesium 129 (Cs 129) | 100 | | Cesium 131 (Cs 131) | 1,000 | | Cesium 134m (Cs 134m) | 100 | | Cesium 134 (Cs 134) | 1 | | Cesium 135 (Cs 135) | 10 | | Cesium 136 (Cs 136) | 10 | | Cesium 137 (Cs 137) | 10 | | Chlorine 36 (Cl 36) | 10 | | Chlorine 38 (Cl 38) | 10 | | Chromium 51 (Cr 51) | 1,000 | | Cobalt 57 (Co 57) | 100 | | Cobalt 58m (Co 58m) | 10 | | Cobalt 58 (Co 58) | 10 | | Cobalt 60 (Co 60) | 1 | | Copper 64 (Cu 64) | 100 | | Dysprosium 165 (Dy 165) | 10 | | Dysprosium 166(Dy 166) | 100 | | Erbium 169 (Er 169) | 100 | | Erbium 171 (Er 171) | 100 | | Europium 152 9.2 h (Eu 152 9.2 h) | 100 | | Europium 152 13 yr (Eu 152 13 yr) | 1 | | Europium 154 (Eu 154) | 1 | | Europium 155(Eu 155) | 10 | | Fluorine 18 (F 18) | 1,000 | | Gadolinium 153 (Gd 153) | 10 | | Gadolinium 159 (Gd 159) | 100 | | Gallium 67 (Ga 67) | 100 | | Gallium 72 (Ga 72) | 10 | | Germanium 68 (Ge 68) | 10 | | Germanium 71 (Ga 71) | 100 | | Gold 195 (Au 195) | 10 | | Gold 198 (Au 198) | 100 | | Gold 199 (Au 199) | 100 | | Hafnium 181 (Hf 181) | 10 | | Holmium 166 (Ho 166) | 100 | | Hydrogen 3 (H3) | 1,000 | | Indium 111 (In 111) | 100 | | Indium 113m (In 113m) | 100 | | Indium 114m(In 114m) | 10 | | Indium 115m(In 115m) | 100 | | Indium 115 (In 115) | 10 | | Iodine 123 (I 123) | 100 | | Iodine 125 (I 125) | 1 | | Iodine 126 (I 126) | 1 | | Iodine 129 (I 129) | 0,1 | | Iodine 131 (I 131) | 1 | | Iodine 132 (I 132) | 10 | | Iodine 133 (I 133) | 1 | | Iodine 134 (I 134) | 10 | | Iodine 135 (I 135) | 10 | | Iridium 192 (Ir 192) | 10 | | Iridium 194 (Ir 194) | 100 | | Iron 52 (Fe 52) | 10 | | Iron 55 (Fe 55) | 100 | | Iron 59 (Fe 59) | 10 | | Krypton 85 (Kr 85) | 100 | | Krypton 87 (Kr 87) | 10 | | Lanthanum 140 (La 140) | 10 | | Lutetium 177 (Lu 177) | 100 | | Manganese 52 (Mn 52) | 10 | | Manganese 54 (Mn 54) | 10 | | Manganese 56 (Mn 56) | 10 | | Mercury 197m (Hg 197m) | 100 | | Mercury 197 (Hg 197) | 100 | | Mercury 203 (Hg 203) | 10 | | Molybdenum 99 (Mo 99) | 100 | | Neodymium 147 (Nd 147) | 100 | | Neodymium 149 (Nd 149) | 100 | | Nickel 59 (Ni 59) | 100 | | Nickel 63 (Ni 63) | 10 | | Nickel 65 (Ni 65) | 100 | | Niobium 93m (Nb 93m) | 10 | | Niobium 95 (Nb 95)` | 10 | | Niobium 97 (Nb 97) | 10 | | Osmium 185 (Os 185) | 10 | | Osmium 191m (Os 191) | 100 | | Osmium 191 (Os 191) | 100 | | Osmium 193 (Os 193) | 100 | | Palladium 103 (Pd 103) | 100 | | Palladium 109(Pd 109) | 100 | | Phosphorus 32 (P 32) | 10 | | Platinum 191 (Pt 191) | 100 | | Platinum 193m(Pt 193m) | 100 | | Platinum 193 (Pt 193) | 100 | | Platinum 197m(Pt 197m) | 100 | | Platinum 197 (Pt 197) | 100 | | Polonium 210 (Po 210) | 0.1 | | Potassium 42 (K 42) | 10 | | Potassium 43 (K 43) | 10 | | Praseodymium 142 (Pr 142) | 100 | | Praseodymium 143 (Pr 143) | 100 | | Promethium 147 (Pm 147) | 10 | | Promethium 149 (Pm 149) | 10 | | Rhenium 186 (Re 186) | 100 | | Rhenium 188 (Re 188) | 100 | | Rhodium 103m (Rh 103m) | 100 | | Rhodium 105 (Rh 105) | 100 | | Rubidium 81 (Rb81) | 10 | | Rubidium 86 (R86) | 10 | | Rubidium 87 (Rb87) | 10 | | Ruthenium 97 (Ru 97) | 100 | | Ruthenium 103 (Ru 103) | 10 | | Ruthenium 105(Ru 105) | 10 | | Ruthenium 106(Ru 106) | 1 | | Samarium 151(Sm 151) | 10 | | Samarium 153(Sm 153) | 100 | | Scandium 46 (Sc 46) | 10 | | Scandium 47 (Sc 47) | 100 | | Scandium 48 (Sc 48) | 10 | | Selenium 75 (Se 75) | 10 | | Silicon 31 (Si 31) | 100 | | Silver 105 (Ag 105) | 10 | | Silver 110m (Ag 110m) | 1 | | Silver 111 (Ag 111) | 100 | | Sodium 22 (Na 22) | 10 | | Sodium 24 (Na 24) | 10 | | Strontium 85 (Sr 85) | 10 | | Strontium 89 (Sr 89) | 1 | | Strontium 90 (Sr 90) | 0.1 | | Strontium 91 (Sr 91) | 10 | | Strontium 92 (Sr 92) | 10 | | Sulphur 35 (S 35) | 100 | | Tantalum 182 (Ta 182) | 10 | | Technetium 96 (Tc 96) | 10 | | Technetium 97m (Tc 97m) | 100 | | Technetium 97 (Tc 97) | 100 | | Technetium 99m (Tc 99m) | 100 | | Technetium 99 (Tc 99) | 10 | | Tellurium 125 m (Te 125 m) | 10 | | Tellurium 127m (Te 127m) | 10 | | Tellurium 127 (Te 127) | 100 | | Tellurium 129m (Te 129m) | 10 | | Tellurium 129 (Te 129) | 100 | | Tellurium 131m (Te 131m) | 10 | | Tellurium 132 (Te 132) | 10 | | Terbium 160 (Tb 160) | 10 | | Thallium 200 (Tl 200) | 100 | | Thallium 201 (Tl 201) | 100 | | Thallium 202 (Tl 202) | 100 | | Thallium 204 (Tl 204) | 10 | | Thulium 170 (Tm 170) | 10 | | Thulium 171 (Tm 171) | 10 | | Tin 113 (Sn 113) | 10 | | Tin 125 (Sn 125) | 10 | | Tungsten 181 (W 181) | 10 | | Tungsten 185 (W 185) | 10 | | Tungsten 187 (W 187) | 100 | | Vanadium 48 (V 48) | 10 | | Xenon 131m (Xe 131m) | 1,000 | | Xenon 133 (Xe 133) | 100 | | Xenon 135 (Xe 135) | 100 | | Ytterbium 175 (Yb 175) | 100 | | Yttrium 87 (Y 87) | 10 | | Yttrium 88 (Y 88) | 10 | | Yttrium 90 (Y 90) | 10 | | Yttrium 91 (Y91) | 10 | | Yttrium 92 (Y92) | 100 | | Yttrium 93 (Y93) | 100 | | Zinc 65 (Zn 65) | 10 | | Zinc 69m (Zn 69m) | 100 | | Zinc 69 (Zn 69) | 1,000 | | Zirconium 93 (Zr 93) | 10 | | Zirconium 95 (Zr 95) | 10 | | Zirconium 97 (Zr 97) | 10 | | Any radioactive material not listed above other than alpha emitting radioactive materials | 0.1 |

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3740 Quantities of radioactive materials requiring consideration of the need for an emergency plan for responding to a release

| Radioactive material¹ | Release fraction | Quantity (curies) | | --- | --- | --- | | Actinium-228 | 0.001 | 4,000 | | Americium-241 | .001 | 2 | | Americium-242 | .001 | 2 | | Americium-243 | .001 | 2 | | Antimony-124 | .01 | 4,000 | | Antimony-126 | .01 | 6,000 | | Barium-133 | .01 | 10,000 | | Barium-140 | .01 | 30,000 | | Bismuth-207 | .01 | 5,000 | | Bismuth-210 | .01 | 600 | | Cadmium-109 | .01 | 1,000 | | Cadmium-113 | .01 | 80 | | Calcium-45 | .01 | 20,000 | | Californium-252 | .001 | g (20 mg) | | Carbon-14 (non-carbon dioxide) | .01 | 50,000 | | Cerium-141 | .01 | 10,000 | | Cerium-144 | .01 | 300 | | Cesium-134 | .01 | 2,000 | | Cesium-137 | .01 | 3,000 | | Chlorine-36 | .5 | 100 | | Chromium-51 | .01 | 300,000 | | Cobalt-60 | .001 | 5,000 | | Copper-64 | .01 | 200,000 | | Curium-242 | .001 | 60 | | Curium-243 | .001 | 3 | | Curium-244 | .001 | 4 | | Curium-245 | .001 | 2 | | Europium-152 | .01 | 500 | | Europium-154 | .01 | 400 | | Europium-155 | .01 | 3,000 | | Germanium-68 | .01 | 2,000 | | Gadolinium-153 | .01 | 5,000 | | Gold-198 | .01 | 30,000 | | Hafnium-172 | .01 | 400 | | Hafnium-181 | .01 | 7,000 | | Holmium-166m | .01 | 100 | | Hydrogen-3 | .5 | 20,000 | | Iodine-125 | .5 | 10 | | Iodine-131 | .5 | 10 | | Indium-114m | .01 | 1,000 | | Iridium-192 | .001 | 40,000 | | Iron-55 | .01 | 40,000 | | Iron-59 | .01 | 7,000 | | Krypton-85 | 1.0 | 6,000,000 | | Lead-210 | .01 | 8 | | Manganese-56 | .01 | 60,000 | | Mercury-203 | .01 | 10,000 | | Molybdenum-99 | .01 | 30,000 | | Neptunium-237 | .001 | 2 | | Nickel-63 | .01 | 20,000 | | Niobium-94 | .01 | 300 | | Phosphorus-32 | .5 | 100 | | Phosphorus-33 | .5 | 1,000 | | Polonium-210 | .01 | 10 | | Potassium-42 | .01 | 9,000 | | Promethium-145 | .01 | 4,000 | | Promethium-147 | .01 | 4,000 | | Radium-226 | .001 | 100 | | Ruthenium-106 | .01 | 200 | | Samarium-151 | .01 | 4,000 | | Scandium-46 | .01 | 3,000 | | Selenium-75 | .01 | 10,000 | | Silver-110m | .01 | 1,000 | | Sodium-22 | .01 | 9,000 | | Sodium-24 | .01 | 10,000 | | Strontium-89 | .01 | 3,000 | | Strontium-90 | .01 | 90 | | Sulfur-35 | .5 | 900 | | Technitium-99 | .01 | 10,000 | | Technitium-99m | .01 | 400,000 | | Tellurium-127m | .01 | 5,000 | | Tellurium-129m | .01 | 5,000 | | Terbium-160 | .01 | 4,000 | | Thulium-170 | .01 | 4,000 | | Tin-113 | .01 | 10,000 | | Tin-123 | .01 | 3,000 | | Tin-126 | .01 | 1,000 | | Titanium-44 | .01 | 100 | | Vanadium-48 | .01 | 7,000 | | Xenon-133 | 1.0 | 900,000 | | Yttrium-91 | .01 | 2,000 | | Zinc-65 | .01 | 5,000 | | Zirconium-93 | .01 | 400 | | Zirconium-95 | .01 | 5,000 | | Any other beta-gamma emitter | .01 | 10,000 | | Mixed fission products | .01 | 1,000 | | Mixed corrosion products | .01 | 10,000 | | Contaminated equipment beta-gamma | .001 | 10,000 | | Irradiated material, any form other than solid noncombustible | .01 | 1,000 | | Irradiated material, solid noncombustible | .001 | 10,000 | | Mixed radioactive waste, beta-gamma | .01 | 1,000 | | Packaged mixed waste, beta-gamma² | .001 | 10,000 | | Any other alpha emitter | .001 | 2 | | Contaminated equipment, alpha | .0001 | 20 | | Packaged waste, alpha² | .0001 | 20 | | Combinations of radioactive materials listed above¹ | | | | ¹For combinations of radioactive materials, consideration of the need for an emergency plan is required if the sum of the ratios of the quantity of each radioactive material authorized to the quantity listed for that material in this section exceeds one. | | | | ²Waste packaged in Type B containers does not require an emergency plan. | | |

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3750 Quantities for use with decommissioning

| | Materials | Microcuries | | | --- | --- | --- | --- | | | Americium-241 | .01 | | | | Antimony-122 | 100 | | | | Antimony-124 | 10 | | | | Antimony-125 | 10 | | | | Arsenic-73 | 100 | | | | Arsenic-74 | 10 | | | | Arsenic-76 | 10 | | | | Arsenic-77 | 100 | | | | Barium-131 | 10 | | | | Barium-133 | 10 | | | | Barium-140 | 10 | | | | Bismuth-210 | 1 | | | | Bromine-82 | 10 | | | | Cadmium-109 | 10 | | | | Cadmium-115m | 10 | | | | Cadmium-115 | 100 | | | | Calcium-45 | 10 | | | | Calcium-47 | 10 | | | | Carbon-14 | 100 | | | | Cerium-141 | 100 | | | | Cerium-143 | 100 | | | | Cerium-144 | 1 | | | | Cesium-131 | 1,000 | | | | Cesium-134m | 100 | | | | Cesium-134 | 1 | | | | Cesium-135 | 10 | | | | Cesium-136 | 10 | | | | Cesium-137 | 10 | | | | Chlorine-36 | 10 | | | | Chlorine-38 | 10 | | | | Chromium-51 | 1,000 | | | | Cobalt-55 | 100 | | | | Cobalt-56 | 10 | | | | Cobalt-57 | 100 | | | | Cobalt-58m | 10 | | | | Cobalt-58 | 10 | | | | Cobalt-60 | 1 | | | | Copper-64 | 100 | | | | Dysprosium-165 | 10 | | | | Dysprosium-166 | 100 | | | | Erbium-169 | 100 | | | | Erbium-171 | 100 | | | | Europium-152 9.2h | 100 | | | | Europium-152 13 yr | 1 | | | | Europium-154 | 1 | | | | Europium-155 | 10 | | | | Fluorine-18 | 1,000 | | | | Gadolinium-153 | 10 | | | | Gadolinium-159 | 100 | | | | Gallium-72 | 10 | | | | Germanium-71 | 100 | | | | Gold-198 | 100 | | | | Gold-199 | 100 | | | | Hafnium-181 | 10 | | | | Holmium-166 | 100 | | | | Hydrogen-3 | 1,000 | | | | Indium-113m | 100 | | | | Indium-114m | 10 | | | | Indium-115m | 100 | | | | Indium-115 | 10 | | | | Iodine-125 | 1 | | | | Iodine-126 | 1 | | | | Iodine-129 | 0.1 | | | | Iodine-131 | 1 | | | | Iodine-132 | 10 | | | | Iodine-133 | 1 | | | | Iodine-134 | 10 | | | | Iodine-135 | 10 | | | | Iridium-192 | 10 | | | | Iridium-194 | 100 | | | | Iron-55 | 100 | | | | Iron-59 | 10 | | | | Krypton-85 | 100 | | | | Krpton-87 | 10 | | | | Lanthanum-140 | 10 | | | | Lutetium-177 | 100 | | | | Manganese-52 | 10 | | | | Manganese-54 | 10 | | | | Manganese-56 | 10 | | | | Mercury-197m | 100 | | | | Mercury-197 | 100 | | | | Mercury-203 | 10 | | | | Molbdenum-99 | 100 | | | | Neodymium-147 | 100 | | | | Neodymium-149 | 100 | | | | Nickel-59 | 100 | | | | Nickel-63 | 10 | | | | Nickel-65 | 100 | | | | Niobium-93m | 10 | | | | Niobium-95 | 10 | | | | Niobium-97 | 10 | | | | Osmium-185 | 10 | | | | Osmium-191m | 100 | | | | Osmium-191 | 100 | | | | Osmium-193 | 100 | | | | Palladium-103 | 100 | | | | Palladium-109 | 100 | | | | Phosphorus-32 | 10 | | | | Platinum-191 | 100 | | | | Platinum-193m | 100 | | | | Platinum-193 | 100 | | | | Platinum-197m | 100 | | | | Platinum-197 | 100 | | | | Plutonium-239 | .01 | | | | Polonium-210 | 0.1 | | | | Potassium-42 | 10 | | | | Praseodymium-142 | 100 | | | | Praseodymium-143 | 100 | | | | Promethium-147 | 10 | | | | Promethium-149 | 10 | | | | Radium-226 | .01 | | | | Rhenium-186 | 100 | | | | Rhenium-188 | 100 | | | | Rhodium-103m | 100 | | | | Rhodium-105 | 100 | | | | Rubidium-86 | 10 | | | | Rubidium-87 | 10 | | | | Ruthenium-97 | 100 | | | | Ruthenium-103 | 10 | | | | Ruthenium-105 | 10 | | | | Ruthenium-106 | 1 | | | | Samarium-151 | 10 | | | | Samarium-153 | 100 | | | | Scandium-46 | 10 | | | | Scandium-47 | 100 | | | | Scandium-48 | 10 | | | | Seleium-75 | 10 | | | | Silicon-31 | 100 | | | | Silver-105 | 10 | | | | Silver-110m | 1 | | | | Silver-111 | 100 | | | | Sodium-24 | 10 | | | | Strontium-85 | 10 | | | | Strontium-89 | 1 | | | | Strontium-90 | 0.1 | | | | Strontium-91 | 10 | | | | Strontium-92 | 10 | | | | Sulphur-35 | 100 | | | | Tantalum-182 | 10 | | | | Technetium-96 | 10 | | | | Technetium-97m | 100 | | | | Technetium-97 | 100 | | | | Technetium-99m | 100 | | | | Technetium-99 | 10 | | | | Tellurium-125m | 10 | | | | Tellurium127m | 10 | | | | Tellurium-127 | 100 | | | | Tellurium129m | 10 | | | | Tellurium-129 | 100 | | | | Tellurium-131m | 10 | | | | Tellurium-132 | 10 | | | | Terbium-160 | 10 | | | | Thallium-200 | 100 | | | | Thallium-201 | 100 | | | | Thallium-202 | 100 | | | | Thallium-204 | 10 | | | | Throium (natural)¹ | 100 | | | | Thulium-170 | 10 | | | | Thulium-171 | 10 | | | | Tin-113 | 10 | | | | Tin-125 | 10 | | | | Tungsten-181 | 10 | | | | Tungsten-185 | 10 | | | | Tungsten-187 | 100 | | | | Uranium (natural)² | 100 | | | | Uranium-233 | .01 | | | | Uranium-234--Uranium-235 | .01 | | | | Vandium-48 | 10 | | | | Xenon-131m | 1,000 | | | | Xenon-133 | 100 | | | | Xenon-135 | 100 | | | | Ytterbium-175 | 100 | | | | Yttrium-90 | 10 | | | | Yttrium-91 | 10 | | | | Yttrium-92 | 100 | | | | Yttrium-93 | 100 | | | | Zinc-65 | 10 | | | | Zinc-69m | 100 | | | | Zinc-69 | 1,000 | | | | Zirconium-93 | 10 | | | | Zirconium-95 | 10 | | | | Zirconium-97 | 10 | | | | Any alpha emitting radionuclide not listed above or mixtures of alpha emitters of unknown composition | .01 | | | | Any radionuclide other than alpha emitting radio-nuclides, not listed above or mixtures of beta emitters of unknown composition | .1 | | | | ¹Based on alpha disintegration rate of Th-232, Th-230, and their daughter products. ²Based on alpha disintegration rate of U-238, U-234, and U-235. | | |

Note: For purposes of 12VAC5-481-930, where there is involved a combination of isotopes in known amounts, the limit for the combination should be derived as follows: Determine, for each isotope in the combination, the ratio between the quantity present in the combination and the limit otherwise established for the specific isotope when not in combination. The sum of such ratios for all the isotopes in the combination may not exceed "1" (i.e., "unity").

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008; amended, Virginia Register Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-3760 Limits for broad scopes

| Radioactive material | Col. I curies | Col. II curies | | --- | --- | --- | | Antimony-122 | 1 | 0.01 | | Antimony-124 | 1 | 0.01 | | Antimony-125 | 1 | 0.01 | | Arsenic-73 | 10 | 0.1 | | Arsenic-74 | 1 | 0.01 | | Arsenic-76 | 1 | 0.01 | | Arsenic-77 | 10 | 0.1 | | Barium-131 | 10 | 0.1 | | Barium-140 | 1 | 0.01 | | Beryllium-7 | 10 | 0.1 | | Bismuth-210 | 0.1 | 0.001 | | Bromine-82 | 10 | 0.1 | | Cadmium-109 | 1 | 0.01 | | Cadmium-115m | 1 | 0.01 | | Cadmium-115 | 10 | 0.1 | | Calcium-45 | 1 | 0.01 | | Calcium-47 | 10 | 0.1 | | Carbon-14 | 100 | 1 | | Cerium-141 | 10 | 0.1 | | Cerium-143 | 10 | 0.1 | | Cerium-144 | 0.1 | 0.001 | | Cesium-131 | 100 | 1 | | Cesium-134m | 100 | 1 | | Cesium-134 | 0.1 | 0.001 | | Cesium-135 | 1 | 0.01 | | Cesium-136 | 10 | 0.1 | | Cesium-137 | 0.1 | 0.001 | | Chlorine-36 | 1 | 0.01 | | Chlorine-38 | 100 | 1 | | Chromium-51 | 100 | 1 | | Cobalt-57 | 10 | 0.1 | | Cobalt-58m | 100 | 1 | | Cobalt-58 | 1 | 0.01 | | Cobalt-60 | 0.1 | 0.001 | | Copper-64 | 10 | 0.1 | | Dysprosium-165 | 100 | 1 | | Dysprosium-166 | 10 | 0.1 | | Erbium-169 | 10 | 0.1 | | Erbium-171 | 10 | 0.1 | | Europium-152 9.2 h | 10 | 0.1 | | Europium-152 13 y | 0.1 | 0.001 | | Europium-154 | 0.1 | 0.001 | | Europium-155 | 1 | 0.01 | | Fluorine-18 | 100 | 1 | | Gadolinium-153 | 1 | 0.01 | | Gadolinium-159 | 10 | 0.1 | | Gallium-72 | 10 | 0.1 | | Germanium-71 | 100 | 1 | | Gold-198 | 10 | 0.1 | | Gold-199 | 10 | 0.1 | | Hafnium-181 | 1 | 0.01 | | Holmium-166 | 10 | 0.1 | | Hydrogen-3 | 100 | 1 | | Indium-113m | 100 | 1 | | Indium-114m | 1 | 0.01 | | Indium-115m | 100 | 1 | | Indium-115 | 1 | 0.01 | | Iodine-125 | 0.1 | 0.001 | | Iodine-126 | 0.1 | 0.001 | | Iodine-129 | 0.1 | 0.001 | | Iodine-131 | 0.1 | 0.001 | | Iodine-132 | 10 | 0.1 | | Iodine-133 | 1 | 0.01 | | Iodine-134 | 10 | 0.1 | | Iodine-135 | 1 | 0.01 | | Iridium-192 | 1 | 0.01 | | Iridium-194 | 10 | 0.1 | | Iron-55 | 10 | 0.1 | | Irion-59 | 1 | 0.01 | | Krypton-85 | 100 | 1 | | Krypton-87 | 10 | 0.1 | | Lanthanum-140 | 1 | 0.01 | | Lutelium-177 | 10 | 0.1 | | Manganese-52 | 1 | 0.01 | | Manganese-54 | 1 | 0.01 | | Manganese-56 | 10 | 0.1 | | Mercury-197m | 10 | 0.1 | | Mercury-197 | 10 | 0.1 | | Mercury-203 | 1 | 0.01 | | Molybdenum-99 | 10 | 0.1 | | Neodymium-147 | 10 | 0.1 | | Neodymium-149 | 10 | 0.1 | | Nickel-59 | 10 | 0.1 | | Nickel-63 | 1 | 0.01 | | Nickel-65 | 10 | 0.1 | | Niobium-93m | 1 | 0.01 | | Niobium-95 | 1 | 0.01 | | Niobium-97 | 100 | 1 | | Osmium-185 | 1 | 0.01 | | Osmium-191m | 100 | 1 | | Osmium-191 | 10 | 0.1 | | Osmium-193 | 10 | 0.1 | | Palladium-103 | 10 | 0.1 | | Palladium-109 | 10 | 0.1 | | Phosphorus-32 | 1 | 0.01 | | Platinum-191 | 10 | 0.1 | | Platinum-193m | 100 | 1 | | Platinum-193 | 10 | 0.1 | | Platinum-197m | 100 | 1 | | Platinum-197 | 100 | .1 | | Polonium-210 | 0.01 | 0.0001 | | Potassium-42 | 1 | 0.01 | | Praseodymium-142 | 10 | 0.1 | | Praseodymium-143 | 10 | 0.1 | | Promethium-147 | 1 | 0.01 | | Promethium-149 | 10 | 0.1 | | Radium-226 | 0.01 | 0.0001 | | Rhenium-186 | 10 | 0.1 | | Rhenium-188 | 10 | 0.1 | | Rhodium-103m | 1,000 | 10 | | Rhodium-105 | 10 | 0.1 | | Rubidium-86 | 1 | 0.01 | | Rubidium-87 | 1 | 0.01 | | Ruthenium-97 | 100 | 1 | | Ruthenium-103 | 1 | 0.01 | | Ruthenium-105 | 10 | 0.1 | | Ruthenium-106 | 0.1 | 0.001 | | Samarium-151 | 1 | 0.01 | | Samarium-153 | 10 | 0.1 | | Scandium-46 | 1 | 0.01 | | Scandium-47 | 10 | 0.1 | | Scandium-48 | 1 | 0.01 | | Selenium-75 | 1 | 0.01 | | Silicon-31 | 10 | 0.1 | | Silver-105 | 1 | 0.01 | | Silver-110m | 0.1 | 0.001 | | Silver-111 | 10 | 0.1 | | Sodium-22 | 0.1 | 0.001 | | Sodium-24 | 1 | 0.01 | | Strontium-85m | 1,000 | 10 | | Strontium-85 | 1 | 0.01 | | Strontium-89 | 1 | 0.01 | | Strontium-90 | 0.01 | 0.0001 | | Strontium-91 | 10 | 0.1 | | Strontium-92 | 10 | 0.1 | | Sulphur-35 | 10 | 0.1 | | Tantalum-182 | 1 | 0.01 | | Technetium-96 | 10 | 0.1 | | Technetium-97m | 10 | 0.1 | | Technetium-97 | 10 | 0.1 | | Technetium-99m | 100 | 1 | | Technetium-99 | 1 | 0.01 | | Tellurium-125m | 1 | 0.01 | | Tellurium-127m | 1 | 0.01 | | Tellurium-127 | 10 | 0.1 | | Tellurium-129m | 1 | 0.01 | | Tellurim-129 | 100 | 1 | | Tellurium-131m | 10 | 0.1 | | Tellurium-132 | 1 | 0.01 | | Terbium-160 | 1 | 0.01 | | Thallium-200 | 10 | 0.1 | | Thallium-201 | 10 | 0.1 | | Thallium-202 | 10 | 0.1 | | Thallium-204 | 1 | 0.01 | | Thulium-170 | 1 | 0.01 | | Thulium-171 | 1 | 0.01 | | Tin-113 | 1 | 0.01 | | Tin-125 | 1 | 0.01 | | Tungsten-181 | 1 | 0.01 | | Tungsten-185 | 1 | 0.01 | | Tungsten-187 | 10 | 0.1 | | Vandadium-48 | 1 | 0.01 | | Xenon-131m | 1,000 | 10 | | Xenon-133 | 100 | 1 | | Xenon-135 | 100 | 1 | | Ytterbium-175 | 10 | 0.1 | | Yttrium-90 | 1 | 0.01 | | Yttrium-91 | 1 | 0.01 | | Yttrium-92 | 10 | 0.1 | | Yttrium-93 | 1 | 0.01 | | Zinc-65 | 1 | 0.01 | | Zinc-69m | 10 | 0.1 | | Zinc-69 | 100 | 1 | | Zirconium-93 | 1 | 0.01 | | Zirconium-95 | 1 | 0.01 | | Zirconium-97 | 1 | 0.01 | | Any radioactive material other than alpha emitting radioactive material not listed above | 0.1 | 0.001 |

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3770 Determination of A1 and A2

A. Values of A₁ and A₂ for individual radionuclides, which are the bases for many activity limits elsewhere in these regulations, are given in Table 1 of this section. The curie (Ci) values specified are obtained by converting from the Terabecquerel (TBq) value. The terabecquerel values are the regulatory standard. The curie values are for information only and are not intended to be the regulatory standard. Where values of A₁ and A₂ are unlimited, it is for radiation control purposes only. For nuclear criticality safety, some materials are subject to controls placed on fissile material.

B. For individual radionuclides whose identities are known, but that are not listed in Table 1 or Table 2 of this section, the A₁ and A₂values or exempt material activity concentration and exempt consignment activity values contained in Table 3 of this section may be used. Otherwise, the licensee shall obtain prior agency approval for radionuclides not listed in Table 1 or Table 2 of this section, before shipping the material. The licensee shall submit requests for prior approval to the agency.

C. In the calculations of A₁ and A₂for a radionuclide not in Table 1 of this section, a single radioactive decay chain, in which radionuclides are present in their naturally occurring proportions, and in which no daughter radionuclide has a half-life either longer than 10 days, or longer than that of the parent radionuclide, shall be considered as a single radionuclide, and the activity to be taken into account, and the A₁ orA₂ value to be applied, shall be those corresponding to the parent radionuclide of that chain. In the case of radioactive decay chains in which any daughter radionuclide has a half-life either longer than 10 days or greater than that of the parent radionuclide, the parent and those daughter radionuclides shall be considered as mixtures of different radionuclides.

D. For mixtures of radionuclides whose identities and respective activities are known, the following conditions apply:

1. For special form radioactive material, the maximum quantity transported in a Type A package is as follows:

where B(i) is the activity of radionuclide (i) in special form, and A₁(i) is the A₁ value for radionuclide (i).

2. For normal form radioactive material, the maximum quantity transported in a Type A package is as follows:

where B(i) is the activity of radionuclide (i) in normal form, and A₂(i) is the A₂ value for radionuclide (i).

3. If the package contains both special and normal form radioactive material, the activity that may be transported in the Type A package is as follows:

Where B(i) is the activity of radionuclide i (i) as special form radioactive material, A₁(i) is the A₁ value for the radionuclide (i), C(j) is the activity of radionuclide (j) as normal form radioactive material, and A₂(j) is the A₂ value for radionuclide (j).

4. Alternatively, the A₁ value for mixtures of special form material may be determined as follows:

where f(i) is the fraction of activity for radionuclide (i) in the mixture, and A₁(i) is the appropriate A₁ value for radionuclide (i).

5. Alternatively, the A₂ value for mixtures of normal form material may be determined as follows:

where f(i) is the fraction of activity for radionuclide (i) in the mixture, and A₂(i) is the appropriate A₂ value for radionuclide (i).

6. The exempt activity concentration for mixtures of nuclides may be determined as follows:

where f(i) is the fraction of activity concentration of radionuclide (i) in the mixture, and A is the activity concentration for exempt material containing radionuclide (i).

7. The activity limit for an exempt consignment for mixtures of radionuclides may be determined as follows:

where f(i) is the fraction of activity of radionuclide (i) in the mixture, and A is the activity limit for exempt consignments for radionuclide (i).

E. When the identity of each radionuclide is known, but the individual activities of some of the radionuclides are not known, the radionuclides may be grouped, and the lowest A₁ or A₂ value or lowest [A] (activity concentration for exempt material or A (activity limit for exempt consignment) value, as appropriate, for the radionuclides in each group may be used in applying the formulas in subsection D of this section. Groups may be based on the total alpha activity and the total beta/gamma activity when these are known, using the lowest A₁ or A₂ values or the lowest [A] or A value, as appropriate, for the alpha emitters and beta/gamma emitters.

F. Table 1. A₁ and A₂ Values for Radionuclides.

| Symbol of radionuclide | Element and atomic number | A₁ (TBq) | A₁(Ci)^b | A₂ (TBq) | A₂(Ci)^b | Specific activity | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | (TBq/g) | (Ci/g) | | | | | | | | | Ac-225 (a) | Actinium (89) | 8.0X10^-1 | 2.2X10^-1 | 6.0X10^-3 | 1.6X10^-1 | 2.1X10³ | 5.8X10⁴ | | | Ac-227 (a) | | 9.0X10^-1 | 2.4X10¹ | 9.0X10^-5 | 2.4X10^-3 | 2.7 | 7.2X10¹ | | | Ac-228 | | 6.0X10^-1 | 1.6X10¹ | 5.0X10^-1 | 1.4X10¹ | 8.4X10⁴ | 2.2X10⁶ | | | Ag-105 | Silver (47) | 2.0 | 5.4X10¹ | 2.0 | 5.4X10¹ | 1.1X10³ | 3.0X10⁴ | | | Ag-108m (a) | | 7.0X10^-1 | 1.9X10¹ | 7.0X10^-1 | 1.9X10¹ | 9.7X10^-1 | 2.6X10¹ | | | Ag-110m (a) | | 4.0X10^-1 | 1.1X10¹ | 4.0X10^-1 | 1.1X10¹ | 1.8X10² | 4.7X10³ | | | Ag-111 | | 2.0 | 5.4X10¹ | 6.0X10^-1 | 1.6X10¹ | 5.8X10³ | 1.6X10⁵ | | | Al-26 | Aluminum (13) | 1.0X10^-1 | 2.7 | 1.0X10^-1 | 2.7 | 7.0X10^-4 | 1.9X10^-2 | | | Am-241 | Americium (95) | 1.0X10¹ | 2.7X10² | 1.0X10^-3 | 2.7X10^-2 | 1.3X10^-1 | 3.4 | | | Am-242m (a) | | 1.0X10¹ | 2.7X10² | 1.0X10^-3 | 2.7X10^-2 | 3.6X10^-1 | 1.0X10¹ | | | Am-243 (a) | | 5.0 | 1.4X10² | 1.0X10^-3 | 2.7X10^-2 | 7.4X10^-3 | 2.0X10^-1 | | | Ar-37 | Argon (18) | 4.0X10¹ | 1.1X10³ | 4.0X101 | 1.1X10³ | 3.7X10³ | 9.9X10⁴ | | | Ar-39 | | 4.0X10¹ | 1.1X10³ | 2.0X10¹ | 5.4X10² | 1.3 | 3.4X10¹ | | | Ar-41 | | 3.0X10^-1 | 8.1 | 3.0X10^-1 | 8.1 | 1.5X106 | 4.2X10⁷ | | | As-72 | Arsenic (33) | 3.0X10^-1 | 8.1 | 3.0X10^-1 | 8.1 | 6.2X10⁴ | 1.7X10⁶ | | | As-73 | | 4.0X10¹ | 1.1X10³ | 4.0X10¹ | 1.1X10³ | 8.2X10² | 2.2X10⁴ | | | As-74 | | 1.0 | 2.7X10¹ | 9.0X10^-1 | 2.4X10¹ | 3.7X10³ | 9.9X10⁴ | | | As-76 | | 3.0X10^-1 | 8.1 | 3.0X10^-1 | 8.1 | 5.8X10⁴ | 1.6X10⁶ | | | As-77 | | 2.0X10¹ | 5.4X10² | 7.0X10^-1 | 1.9X10¹ | 3.9X10⁴ | 1.0X10⁶ | | | At-211 (a) | Astatine (85) | 2.0X10¹ | 5.4X10² | 5.0X10^-1 | 1.4X10¹ | 7.6X10⁴ | 2.1X10⁶ | | | Au-193 | Gold (79) | 7.0 | 1.9X10² | 2.0 | 5.4X10¹ | 3.4X10⁴ | 9.2X10⁵ | | | Au-194 | | 1.0 | 2.7X10¹ | 1.0 | 2.7X10¹ | 1.5X10⁴ | 4.1X10⁵ | | | Au-195 | | 1.0X10¹ | 2.7X10² | 6.0 | 1.6X10² | 1.4X10² | 3.7X10³ | | | Au-198 | | 1.0 | 2.7X10¹ | 6.0X10^-1 | 1.6X10¹ | 9.0X10³ | 2.4X10⁵ | | | Au-199 | | 1.0X10¹ | 2.7X10² | 6.0X10^-1 | 1.6X10¹ | 7.7X10³ | 2.1X10⁵ | | | Ba-131 (a) | Barium (56) | 2.0 | 5.4X10¹ | 2.0 | 5.4X10¹ | 3.1X10³ | 8.4X10⁴ | | | Ba-133 | | 3.0 | 8.1X10¹ | 3.0 | 8.1X10¹ | 9.4 | 2.6X10² | | | Ba-133m | | 2.0X10¹ | 5.4X10² | 6.0X10^-1 | 1.6X10¹ | 2.2X10⁴ | 6.1X10⁵ | | | Ba-140 (a) | | 5.0X10^-1 | 1.4X101 | 3.0X10^-1 | 8.1 | 2.7X103 | 7.3X10⁴ | | | Be-7 | Beryllium (4) | 2.0X10¹ | 5.4X10² | 2.0X101 | 5.4X102 | 1.3X10⁴ | 3.5X10⁵ | | | Be-10 | | 4.0X10¹ | 1.1X10³ | 6.0X10^-1 | 1.6X10¹ | 8.3X10^-4 | 2.2X10^-2 | | | Bi-205 | Bismuth (83) | 7.0X10^-1 | 1.9X10¹ | 7.0X10^-1 | 1.9X10¹ | 1.5X10³ | 4.2X10⁴ | | | Bi-206 | | 3.0X10^-1 | 8.1 | 3.0X10^-1 | 8.1 | 3.8X10³ | 1.0X10⁵ | | | Bi-207 | | 7.0X10^-1 | 1.9X10¹ | 7.0X10^-1 | 1.9X10¹ | 1.9 | 5.2X10¹ | | | Bi-210 | | 1.0 | 2.7X10¹ | 6.0X10^-1 | 1.6X10¹ | 4.6X10³ | 1.2X10⁵ | | | Bi-210m (a) | | 6.0X10^-1 | 1.6X10¹ | 2.0X10^-2 | 5.4X10^-1 | 2.1X10^-5 | 5.7X10^-4 | | | Bi-212 (a) | | 7.0X10^-1 | 1.9X10¹ | 6.0X10^-1 | 1.6X10¹ | 5.4X10⁵ | 1.5X10⁷ | | | Bk-247 | Berkelium (97) | 8.0 | 2.2X10² | 8.0X10^-4 | 2.2X10-2 | 3.8X10^-2 | 1.0 | | | Bk-249 (a) | | 4.0X10¹ | 1.1X103 | 3.0X10^-1 | 8.1 | 6.1X10¹ | 1.6X10³ | | | Br-76 | Bromine (35) | 4.0X10^-1 | 1.1X101 | 4.0X10^-1 | 1.1X10¹ | 9.4X10⁴ | 2.5X10⁶ | | | Br-77 | | 3.0 | 8.1X10¹ | 3.0 | 8.1X10¹ | 2.6X10⁴ | 7.1X10⁵ | | | Br-82 | | 4.0X10^-1 | 1.1X10¹ | 4.0X10^-1 | 1.1X10¹ | 4.0X10⁴ | 1.1X10⁶ | | | C-11 | Carbon (6) | 1.0 | 2.7X10¹ | 6.0X10^-1 | 1.6X10¹ | 3.1X10⁷ | 8.4X10⁸ | | | C-14 | | 4.0X10¹ | 1.1X10³ | 3.0 | 8.1X10¹ | 1.6X10^-1 | 4.5 | | | Ca-41 | Calcium (20) | Unlimited | Unlimited | Unlimited | Unlimited | 3.1X10^-3 | 8.5X10^-2 | | | Ca-45 | | 4.0X10¹ | 1.1X10³ | 1.0 | 2.7X10¹ | 6.6X10² | 1.8X10⁴ | | | Ca-47 (a) | | 3.0 | 8.1X10¹ | 3.0X10^-1 | 8.1 | 2.3X10⁴ | 6.1X10⁵ | | | Cd-109 | Cadmium (48) | 3.0X10¹ | 8.1X10² | 2.0 | 5.4X10¹ | 9.6X10¹ | 2.6X10³ | | | Cd-113m | | 4.0X10¹ | 1.1X10³ | 5.0X10^-1 | 1.4X10¹ | 8.3 | 2.2X10² | | | Cd-115 (a) | | 3.0 | 8.1X10¹ | 4.0X10^-1 | 1.1X10¹ | 1.9X10⁴ | 5.1X10⁵ | | | Cd-115m | | 5.0X10^-1 | 1.4X10¹ | 5.0X10^-1 | 1.4X10¹ | 9.4X10² | 2.5X10⁴ | | | Ce-139 | Cerium (58) | 7.0 | 1.9X10² | 2.0 | 5.4X10¹ | 2.5X10² | 6.8X10³ | | | Ce-141 | | 2.0X10¹ | 5.4X10² | 6.0X10^-1 | 1.6X10¹ | 1.1X10³ | 2.8X10⁴ | | | Ce-143 | | 9.0X10^-1 | 2.4X10¹ | 6.0X10^-1 | 1.6X10¹ | 2.5X10⁴ | 6.6X10⁵ | | | Ce-144 (a) | | 2.0X10^-1 | 5.4 | 2.0X10^-1 | 5.4 | 1.2X10² | 3.2X10³ | | | Cf-248 | Californium (98) | 4.0X10¹ | 1.1X10³ | 6.0X10^-3 | 1.6X10^-1 | 5.8X10¹ | 1.6X10³ | | | Cf-249 | | 3.0 | 8.1X10¹ | 8.0X10^-4 | 2.2X10^-2 | 1.5X10^-1 | 4.1 | | | Cf-250 | | 2.0X10¹ | 5.4X10² | 2.0X10^-3 | 5.4X10^-2 | 4.0 | 1.1X10² | | | Cf-251 | | 7.0 | 1.9X10² | 7.0X10^-4 | 1.9X10^-2 | 5.9X10^-2 | 1.6 | | | Cf-252 | | 1.0X10^-1 | 2.7 | 3.0X10^-3 | 8.1X10^-2 | 2.0X10¹ | 5.4X10² | | | Cf-253 (a) | | 4.0X10¹ | 1.1X10³ | 4.0X10^-2 | 1.1 | 1.1X10³ | 2.9X10⁴ | | | Cf-254 | | 1.0X10^-3 | 2.7X10^-2 | 1.0X10^-3 | 2.7X10^-2 | 3.1X10² | 8.5X10³ | | | Cl-36 | Chlorine (17) | 1.0X10¹ | 2.7X10² | 6.0X10^-1 | 1.6X10¹ | 1.2X10^-3 | 3.3X10^-2 | | | Cl-38 | | 2.0X10^-1 | 5.4 | 2.0X10^-1 | 5.4 | 4.9X10⁶ | 1.3X10⁸ | | | Cm-240 | Curium (96) | 4.0X10¹ | 1.1X10³ | 2.0X10^-2 | 5.4X10^-1 | 7.5X10² | 2.0X10⁴ | | | Cm-241 | | 2.0 | 5.4X10¹ | 1.0 | 2.7X10¹ | 6.1X10² | 1.7X10⁴ | | | Cm-242 | | 4.0X10¹ | 1.1X10³ | 1.0X10^-2 | 2.7X10^-1 | 1.2X10² | 3.3X10³ | | | Cm-243 | | 9.0 | 2.4X10² | 1.0X10^-3 | 2.7X10^-2 | 1.9X10^-3 | 5.2X10⁴ | | | Cm-244 | | 2.0X10¹ | 5.4X10² | 2.0X10^-3 | 5.4X10^-2 | 3.0 | 8.1X10¹ | | | Cm-245 | | 9.0 | 2.4X10² | 9.0X10^-4 | 2.4X10^-2 | 6.4X10^-3 | 1.7X10^-1 | | | Cm-246 | | 9.0 | 2.4X10² | 9.0X10^-4 | 2.4X10^-2 | 1.1X10^-2 | 3.1X10^-1 | | | Cm-247 (a) | | 3.0 | 8.1X10¹ | 1.0X10^-3 | 2.7X10^-2 | 3.4X10^-6 | 9.3X10^-5 | | | Cm-248 | | 2.0X10^-2 | 5.4X10^-1 | 3.0X10^-4 | 8.1X10^-3 | 1.6X10^-4 | 4.2X10^-3 | | | Co-55 | Cobalt (27) | 5.0X10^-1 | 1.4X10¹ | 5.0X10^-1 | 1.4X10¹ | 1.1X10⁵ | 3.1X10⁶ | | | Co-56 | | 3.0X10^-1 | 8.1 | 3.0X10^-1 | 8.1 | 1.1X10³ | 3.0X10⁴ | | | Co-57 | | 1.0X101 | 2.7X10² | 1.0X10¹ | 2.7X10² | 3.1X10² | 8.4X10³ | | | Co-58 | | 1.0 | 2.7X10¹ | 1.0 | 2.7X10¹ | 1.2X10³ | 3.2X10⁴ | | | Co-58m | | 4.0X101 | 1.1X10³ | 4.0X10¹ | 1.1X10³ | 2.2X10⁵ | 5.9X10⁶ | | | Co-60 | | 4.0X10^-1 | 1.1X10¹ | 4.0X10^-1 | 1.1X10¹ | 4.2X10¹ | 1.1X10³ | | | Cr-51 | Chromium (24) | 3.0X101 | 8.1X10² | 3.0X10¹ | 8.1X10² | 3.4X10³ | 9.2X10⁴ | | | Cs-129 | Cesium (55) | 4.0 | 1.1X10² | 4.0 | 1.1X10² | 2.8X104 | 7.6X10⁵ | | | Cs-131 | | 3.0X10¹ | 8.1X10² | 3.0X10¹ | 8.1X10² | 3.8X10³ | 1.0X10⁵ | | | Cs-132 | | 1.0 | 2.7X10¹ | 1.0 | 2.7X10¹ | 5.7X10³ | 1.5X10⁵ | | | Cs-134 | | 7.0X10^-1 | 1.9X10¹ | 7.0X10^-1 | 1.9X10¹ | 4.8X10¹ | 1.3X10³ | | | Cs-134m | | 4.0X10¹ | 1.1X10³ | 6.0X10^-1 | 1.6X10¹ | 3.0X10⁵ | 8.0X10⁶ | | | Cs-135 | | 4.0X10¹ | 1.1X10³ | 1.0 | 2.7X10¹ | 4.3X10^-5 | 1.2X10^-3 | | | Cs-136 | | 5.0X10^-1 | 1.4X10¹ | 5.0X10^-1 | 1.4X10¹ | 2.7X10³ | 7.3X10⁴ | | | Cs-137 (a) | | 2.0 | 5.4X10¹ | 6.0X10^-1 | 1.6X101 | 3.2 | 8.7X10¹ | | | Cu-64 | Copper (29) | 6.0 | 1.6X10² | 1.0 | 2.7X10¹ | 1.4X10⁵ | 3.9X10⁶ | | | Cu-67 | | 1.0X10¹ | 2.7X10² | 7.0X10^-1 | 1.9X10¹ | 2.8X10⁴ | 7.6X10⁵ | | | Dy-159 | Dysprosium (66) | 2.0X10¹ | 5.4X10² | 2.0X10¹ | 5.4X10² | 2.1X10² | 5.7X10³ | | | Dy-165 | | 9.0X10^-1 | 2.4X10¹ | 6.0X10^-1 | 1.6X10¹ | 3.0X10⁵ | 8.2X10⁶ | | | Dy-166 (a) | | 9.0X10^-1 | 2.4X10¹ | 3.0X10^-1 | 8.1 | 8.6X10³ | 2.3X10⁵ | | | Er-169 | Erbium (68) | 4.0X10¹ | 1.1X10³ | 1.0 | 2.7X10¹ | 3.1X10³ | 8.3X10⁴ | | | Er-171 | | 8.0X10^-1 | 2.2X10¹ | 5.0X10^-1 | 1.4X10¹ | 9.0X10⁴ | 2.4X10⁶ | | | Eu-147 | Europium (63) | 2.0 | 5.4X10¹ | 2.0 | 5.4X10¹ | 1.4X10³ | 3.7X10⁴ | | | Eu-148 | | 5.0X10^-1 | 1.4X10¹ | 5.0X10^-1 | 1.4X10¹ | 6.0X10² | 1.6X10⁴ | | | Eu-149 | | 2.0X10¹ | 5.4X10² | 2.0X10¹ | 5.4X10² | 3.5X10² | 9.4X10³ | | | Eu-150 (short lived) | | 2.0 | 5.4X10¹ | 7.0X10^-1 | 1.9X10¹ | 6.1X10⁴ | 1.6X10⁶ | | | Eu-150 (long lived) | | 7.0X10^-1 | 1.9X10¹ | 7.0X10^-1 | 1.9X10¹ | 6.1X10⁴ | 1.6X10⁶ | | | Eu-152 | | 1.0 | 2.7X10¹ | 1.0 | 2.7X10¹ | 6.5 | 1.8X10² | | | Eu-152m | | 8.0X10^-1 | 2.2X10¹ | 8.0X10^-1 | 2.2X10¹ | 8.2X10⁴ | 2.2X10⁶ | | | Eu-154 | | 9.0X10^-1 | 2.4X10¹ | 6.0X10^-1 | 1.6X10¹ | 9.8 | 2.6X10² | | | Eu-155 | | 2.0X10¹ | 5.4X10² | 3.0 | 8.1X10¹ | 1.8X10¹ | 4.9X10² | | | Eu-156 | | 7.0X10^-1 | 1.9X10¹ | 7.0X10^-1 | 1.9X10¹ | 2.0X10³ | 5.5X10⁴ | | | F-18 | Fluorine (9) | 1.0 | 2.7X10¹ | 6.0X10^-1 | 1.6X10¹ | 3.5X10⁶ | 9.5X107 | | | Fe-52 (a) | Iron (26) | 3.0X10^-1 | 8.1 | 3.0X10^-1 | 8.1 | 2.7X10⁵ | 7.3X10⁶ | | | Fe-55 | | 4.0X10¹ | 1.1X10³ | 4.0X10¹ | 1.1X10³ | 8.8X10¹ | 2.4X10³ | | | Fe-59 | | 9.0X10^-1 | 2.4X10¹ | 9.0X10^-1 | 2.4X10¹ | 1.8X10³ | 5.0X10⁴ | | | Fe-60 (a) | | 4.0X10¹ | 1.1X10³ | 2.0X10^-1 | 5.4 | 7.4X10^-4 | 2.0X10^-2 | | | Ga-67 | Gallium (31) | 7.0 | 1.9X10² | 3.0 | 8.1X10¹ | 2.2X10⁴ | 6.0X10⁵ | | | Ga-68 | | 5.0X10^-1 | 1.4X10¹ | 5.0X10^-1 | 1.4X10¹ | 1.5X10⁶ | 4.1X10⁷ | | | Ga-72 | | 4.0X10^-1 | 1.1X10¹ | 4.0X10^-1 | 1.1X10¹ | 1.1X10⁵ | 3.1X10⁶ | | | Gd-146 (a) | Gadolinium (64) | 5.0X10^-1 | 1.4X10¹ | 5.0X10^-1 | 1.4X10¹ | 6.9X10² | 1.9X10⁴ | | | Gd-148 | | 2.0X10¹ | 5.4X10² | 2.0X10^-3 | 5.4X10^-2 | 1.2 | 3.2X10¹ | | | Gd-153 | | 1.0X10¹ | 2.7X10² | 9.0 | 2.4X10² | 1.3X10² | 3.5X10³ | | | Gd-159 | | 3.0 | 8.1X10¹ | 6.0X10^-1 | 1.6X10¹ | 3.9X10⁴ | 1.1X10⁶ | | | Ge-68 (a) | Germanium (32) | 5.0X10^-1 | 1.4X10¹ | 5.0X10^-1 | 1.4X10¹ | 2.6X10² | 7.1X10³ | | | Ge-71 | | 4.0X10¹ | 1.1X10³ | 4.0X10¹ | 1.1X10³ | 5.8X10³ | 1.6X10⁵ | | | Ge-77 | | 3.0X10^-1 | 8.1 | 3.0X10^-1 | 8.1 | 1.3X10⁵ | 3.6X10⁶ | | | Hf-172 (a) | Hafnium (72) | 6.0X10^-1 | 1.6X10¹ | 6.0X10^-1 | 1.6X10¹ | 4.1X10¹ | 1.1X10³ | | | Hf-175 | | 3.0 | 8.1X10¹ | 3.0 | 8.1X10¹ | 3.9X10² | 1.1X10⁴ | | | Hf-181 | | 2.0 | 5.4X10¹ | 5.0X10^-1 | 1.4X10¹ | 6.3X10² | 1.7X10⁴ | | | Hf-182 | | Unlimited | Unlimited | Unlimited | Unlimited | 8.1X10^-6 | 2.2X10^-4 | | | Hg-194 (a) | Mercury (80) | 1.0 | 2.7X10¹ | 1.0 | 2.7X10¹ | 1.3X10^-1 | 3.5 | | | Hg-195m (a) | | 3.0 | 8.1X10¹ | 7.0X10^-1 | 1.9X10¹ | 1.5X10⁴ | 4.0X10⁵ | | | Hg-197 | | 2.0X10¹ | 5.4X10² | 1.0X10¹ | 2.7X10² | 9.2X10³ | 2.5X10⁵ | | | Hg-197m | | 1.0X10¹ | 2.7X10² | 4.0X10^-1 | 1.1X10¹ | 2.5X10⁴ | 6.7X10⁵ | | | Hg-203 | | 5.0 | 1.4X10² | 1.0 | 2.7X10¹ | 5.1X10² | 1.4X10⁴ | | | Ho-166 | Holmium (67) | 4.0X10^-1 | 1.1X10¹ | 4.0X10^-1 | 1.1X10¹ | 2.6X10⁴ | 7.0X10⁵ | | | Ho-166m | | 6.0X10^-1 | 1.6X10¹ | 5.0X10^-1 | 1.4X10¹ | 6.6X10^-2 | 1.8 | | | I-123 | Iodine (53) | 6.0 | 1.6X10² | 3.0 | 8.1X10¹ | 7.1X10⁴ | 1.9X10⁶ | | | I-124 | | 1.0 | 2.7X10¹ | 1.0 | 2.7X10¹ | 9.3X10³ | 2.5X10⁵ | | | I-125 | | 2.0X10¹ | 5.4X10² | 3.0 | 8.1X10¹ | 6.4X10² | 1.7X10⁴ | | | I-126 | | 2.0 | 5.4X10¹ | 1.0 | 2.7X10¹ | 2.9X10³ | 8.0X10⁴ | | | I-129 | | Unlimited | Unlimited | Unlimited | Unlimited | 6.5X10^-6 | 1.8X10^-4 | | | I-131 | | 3.0 | 8.1X10¹ | 7.0X10^-1 | 1.9X10¹ | 4.6X10³ | 1.2X10⁵ | | | I-132 | | 4.0X10^-1 | 1.1X10¹ | 4.0X10^-1 | 1.1X10¹ | 3.8X10⁵ | 1.0X10⁷ | | | I-133 | | 7.0X10^-1 | 1.9X10¹ | 6.0X10^-1 | 1.6X10¹ | 4.2X10⁴ | 1.1X10⁶ | | | I-134 | | 3.0X10^-1 | 8.1 | 3.0X10^-1 | 8.1 | 9.9X10⁵ | 2.7X10⁷ | | | I-135 (a) | | 6.0X10^-1 | 1.6X10¹ | 6.0X10^-1 | 1.6X10¹ | 1.3X10⁵ | 3.5X10⁶ | | | In-111 | Indium (49) | 3.0 | 8.1X10¹ | 3.0 | 8.1X10¹ | 1.5X10⁴ | 4.2X10⁵ | | | In-113m | | 4.0 | 1.1X10² | 2.0 | 5.4X10¹ | 6.2X10⁵ | 1.7X10⁷ | | | In-114m (a) | | 1.0X10¹ | 2.7X10² | 5.0X10^-1 | 1.4X10¹ | 8.6X10² | 2.3X10⁴ | | | In-115m | | 7.0 | 1.9X10² | 1.0 | 2.7X10¹ | 2.2X10⁵ | 6.1X10⁶ | | | Ir-189 (a) | Iridium (77) | 1.0X10¹ | 2.7X10² | 1.0X10¹ | 2.7X10² | 1.9X10³ | 5.2X10⁴ | | | Ir-190 | | 7.0X10^-1 | 1.9X10¹ | 7.0X10^-1 | 1.9X10¹ | 2.3X10³ | 6.2X10⁴ | | | Ir-192 | | 1.0 (c) | 2.7X10¹(c) | 6.0X10^-1 | 1.6X10¹ | 3.4X10² | 9.2X10³ | | | Ir-194 | | 3.0X10^-1 | 8.1 | 3.0X10^-1 | 8.1 | 3.1X10⁴ | 8.4X10⁵ | | | K-40 | Potassium (19) | 9.0X10^-1 | 2.4X10¹ | 9.0X10^-1 | 2.4X10¹ | 2.4X10^-7 | 6.4X10^-6 | | | K-42 | | 2.0X10^-1 | 5.4 | 2.0X10^-1 | 5.4 | 2.2X10⁵ | 6.0X10⁶ | | | K-43 | | 7.0X10^-1 | 1.9X10¹ | 6.0X10^-1 | 1.6X10¹ | 1.2X10⁵ | 3.3X10⁶ | | | Kr-79 | Krypton (36) | 4.0 | 1.1X10² | 2.0 | 5.4X10¹ | 4.2X10⁴ | 1.1X10⁶ | | | Kr-81 | | 4.0X10¹ | 1.1X10³ | 4.0X10¹ | 1.1X10³ | 7.8X10^-4 | 2.1X10^-2 | | | Kr-85 | | 1.0X10¹ | 2.7X10² | 1.0X10¹ | 2.7X10² | 1.5X10¹ | 3.9X10² | | | Kr-85m | | 8.0 | 2.2X10² | 3.0 | 8.1X10¹ | 3.0X10⁵ | 8.2X10⁶ | | | Kr-87 | | 2.0X10^-1 | 5.4 | 2.0X10^-1 | 5.4 | 1.0X10⁶ | 2.8X10⁷ | | | La-137 | Lanthanum (57) | 3.0X10¹ | 8.1X10² | 6.0 | 1.6X10² | 1.6X10^-3 | 4.4X10^-2 | | | La-140 | | 4.0X10^-1 | 1.1X10¹ | 4.0X10^-1 | 1.1X10¹ | 2.1X10⁴ | 5.6X10⁵ | | | Lu-172 | Lutetium (71) | 6.0X10^-1 | 1.6X10¹ | 6.0X10^-1 | 1.6X10¹ | 4.2X10³ | 1.1X10⁵ | | | Lu-173 | | 8.0 | 2.2X10² | 8.0 | 2.2X10² | 5.6X10¹ | 1.5X10³ | | | Lu-174 | | 9.0 | 2.4X10² | 9.0 | 2.4X10² | 2.3X10¹ | 6.2X10² | | | Lu-174m | | 2.0X10¹ | 5.4X10² | 1.0X10¹ | 2.7X10² | 2.0X10² | 5.3X10³ | | | Lu-177 | | 3.0X10¹ | 8.1X10² | 7.0X10^-1 | 1.9X10¹ | 4.1X10³ | 1.1X10⁵ | | | Mg-28 (a) | Magnesium (12) | 3.0X10^-1 | 8.1 | 3.0X10^-1 | 8.1 | 2.0X10⁵ | 5.4X10⁶ | | | Mn-52 | Manganese (25) | 3.0X10^-1 | 8.1 | 3.0X10^-1 | 8.1 | 1.6X10⁴ | 4.4X10⁵ | | | Mn-53 | | Unlimited | Unlimited | Unlimited | Unlimited | 6.8X10^-5 | 1.8X10^-3 | | | Mn-54 | | 1.0 | 2.7X10¹ | 1.0 | 2.7X10¹ | 2.9X10² | 7.7X10³ | | | Mn-56 | | 3.0X10^-1 | 8.1 | 3.0X10^-1 | 8.1 | 8.0X10⁵ | 2.2X10⁷ | | | Mo-93 | Molybdenum (42) | 4.0X10¹ | 1.1X10³ | 2.0X10¹ | 5.4X10² | 4.1X10^-2 | 1.1 | | | Mo-99 (a) (h) | | 1.0 | 2.7X10¹ | 6.0X10^-1 | 1.6X10¹ | 1.8X10⁴ | 4.8X10⁵ | | | N-13 | Nitrogen (7) | 9.0X10^-1 | 2.4X10¹ | 6.0X10^-1 | 1.6X10¹ | 5.4X107 | 1.5X10⁹ | | | Na-22 | Sodium (11) | 5.0X10^-1 | 1.4X10¹ | 5.0X10^-1 | 1.4X10¹ | 2.3X10² | 6.3X10³ | | | Na-24 | | 2.0X10^-1 | 5.4 | 2.0X10^-1 | 5.4 | 3.2X10⁵ | 8.7X10⁶ | | | Nb-93m | Niobium (41) | 4.0X10¹ | 1.1X10³ | 3.0X10¹ | 8.1X10² | 8.8 | 2.4X10² | | | Nb-94 | | 7.0X10^-1 | 1.9X10¹ | 7.0X10^-1 | 1.9X10¹ | 6.9X10^-3 | 1.9X10^-1 | | | Nb-95 | | 1.0 | 2.7X10¹ | 1.0 | 2.7X10¹ | 1.5X10³ | 3.9X10⁴ | | | Nb-97 | | 9.0X10^-1 | 2.4X10¹ | 6.0X10^-1 | 1.6X10¹ | 9.9X10⁵ | 2.7X10⁷ | | | Nd-147 | Neodymium (60) | 6.0 | 1.6X10² | 6.0X10^-1 | 1.6X10¹ | 3.0X10³ | 8.1X10⁴ | | | Nd-149 | | 6.0X10^-1 | 1.6X10¹ | 5.0X10^-1 | 1.4X10¹ | 4.5X10⁵ | 1.2X1⁰⁷ | | | Ni-59 | Nickel (28) | Unlimited | Unlimited | Unlimited | Unlimited | 3.0X10^-3 | 8.0X10^-2 | | | Ni-63 | | 4.0X10¹ | 1.1X10³ | 3.0X10¹ | 8.1X10² | 2.1 | 5.7X10¹ | | | Ni-65 | | 4.0X10^-1 | 1.1X10¹ | 4.0X10^-1 | 1.1X10¹ | 7.1X10⁵ | 1.9X10⁷ | | | Np-235 | Neptunium (93) | 4.0X10¹ | 1.1X10³ | 4.0X10¹ | 1.1X10³ | 5.2X10¹ | 1.4X10³ | | | Np-236 (short-lived) | | 2.0X10¹ | 5.4X10² | 2.0 | 5.4X10¹ | 4.7X10^-4 | 1.3X10^-2 | | | Np-236 (long-lived) | | 9.0X100 | 2.4X10² | 2.0X10^-2 | 5.4X10^-1 | 4.7X10^-4 | 1.3X10^-2 | | | Np-237 | | 2.0X10¹ | 5.4X10² | 2.0X10^-3 | 5.4X10^-2 | 2.6X10^-5 | 7.1X10^-4 | | | Np-239 | | 7.0 | 1.9X10² | 4.0X10^-1 | 1.1X10¹ | 8.6X10³ | 2.3X10⁵ | | | Os-185 | Osmium (76) | 1.0 | 2.7X10¹ | 1.0 | 2.7X10¹ | 2.8X10² | 7.5X10³ | | | Os-191 | | 1.0X10¹ | 2.7X10² | 2.0 | 5.4X10¹ | 1.6X10³ | 4.4X10⁴ | | | Os-191m | | 4.0X10¹ | 1.1X10³ | 3.0X10¹ | 8.1X10² | 4.6X10⁴ | 1.3X10⁶ | | | Os-193 | | 2.0 | 5.4X10¹ | 6.0X10^-1 | 1.6X10¹ | 2.0X10⁴ | 5.3X10⁵ | | | Os-194 (a) | | 3.0X10^-1 | 8.1 | 3.0X10^-1 | 8.1 | 1.1X10¹ | 3.1X10² | | | P-32 | Phosphorus (15) | 5.0X10^-1 | 1.4X10¹ | 5.0X10^-1 | 1.4X10¹ | 1.1X10⁴ | 2.9X10⁵ | | | P-33 | | 4.0X10¹ | 1.1X10³ | 1.0 | 2.7X10¹ | 5.8X10³ | 1.6X10⁵ | | | Pa-230 (a) | Protactinium (91) | 2.0 | 5.4X10¹ | 7.0X10^-2 | 1.9 | 1.2X10³ | 3.3X10⁴ | | | Pa-231 | | 4.0 | 1.1X10² | 4.0X10^-4 | 1.1X10^-2 | 1.7X10^-3 | 4.7X10^-2 | | | Pa-233 | | 5.0 | 1.4X10² | 7.0X10^-1 | 1.9X10¹ | 7.7X10² | 2.1X10⁴ | | | Pb-201 | Lead (82) | 1.0 | 2.7X10¹ | 1.0 | 2.7X10¹ | 6.2X10⁴ | 1.7X10⁶ | | | Pb-202 | | 4.0X10¹ | 1.1X10³ | 2.0X10¹ | 5.4X10² | 1.2X10^-4 | 3.4X10^-3 | | | Pb-203 | | 4.0 | 1.1X10² | 3.0 | 8.1X10¹ | 1.1X10⁴ | 3.0X10⁵ | | | Pb-205 | | Unlimited | Unlimited | Unlimited | Unlimited | 4.5X10^-6 | 1.2X10^-4 | | | Pb-210 (a) | | 1.0 | 2.7X10¹ | 5.0X10^-2 | 1.4 | 2.8 | 7.6X10¹ | | | Pb-212 (a) | | 7.0X10^-1 | 1.9X10¹ | 2.0X10^-1 | 5.4 | 5.1X10⁴ | 1.4X10⁶ | | | Pd-103 (a) | Palladium (46) | 4.0X10¹ | 1.1X10³ | 4.0X10¹ | 1.1X10³ | 2.8X10³ | 7.5X10⁴ | | | Pd-107 | | Unlimited | Unlimited | Unlimited | Unlimited | 1.9X10^-5 | 5.1X10^-4 | | | Pd-109 | | 2.0 | 5.4X10¹ | 5.0X10^-1 | 1.4X10¹ | 7.9X10⁴ | 2.1X10⁶ | | | Pm-143 | Promethium (61) | 3.0 | 8.1X10¹ | 3.0 | 8.1X10¹ | 1.3X10² | 3.4X10³ | | | Pm-144 | | 7.0X10^-1 | 1.9X10¹ | 7.0X10^-1 | 1.9X10¹ | 9.2X10¹ | 2.5X10³ | | | Pm-145 | | 3.0X10¹ | 8.1X10² | 1.0X10¹ | 2.7X10² | 5.2 | 1.4X10² | | | Pm-147 | | 4.0X10¹ | 1.1X10³ | 2.0 | 5.4X10¹ | 3.4X10¹ | 9.3X10² | | | Pm-148m (a) | | 8.0X10^-1 | 2.2X10¹ | 7.0X10^-1 | 1.9X10¹ | 7.9X10² | 2.1X10⁴ | | | Pm-149 | | 2.0 | 5.4X10¹ | 6.0X10^-1 | 1.6X10¹ | 1.5X10⁴ | 4.0X10⁵ | | | Pm-151 | | 2.0 | 5.4X10¹ | 6.0X10^-1 | 1.6X10¹ | 2.7X10⁴ | 7.3X10⁵ | | | Po-210 | Polonium (84) | 4.0X10¹ | 1.1X10³ | 2.0X10^-2 | 5.4X10^-1 | 1.7X10² | 4.5X10³ | | | Pr-142 | Praseodymium (59) | 4.0X10^-1 | 1.1X10¹ | 4.0X10^-1 | 1.1X10¹ | 4.3X10⁴ | 1.2X10⁶ | | | Pr-143 | | 3.0 | 8.1X10¹ | 6.0X10^-1 | 1.6X10¹ | 2.5X10³ | 6.7X10⁴ | | | Pt-188 (a) | Platinum (78) | 1.0 | 2.7X10¹ | 8.0X10^-1 | 2.2X10¹ | 2.5X10³ | 6.8X10⁴ | | | Pt-191 | | 4.0 | 1.1X10² | 3.0 | 8.1X10¹ | 8.7X10³ | 2.4X10⁵ | | | Pt-193 | | 4.0X10¹ | 1.1X10³ | 4.0X10¹ | 1.1X10³ | 1.4 | 3.7X10¹ | | | Pt-193m | | 4.0X10¹ | 1.1X10³ | 5.0X10^-1 | 1.4X10¹ | 5.8X10³ | 1.6X10⁵ | | | Pt-195m | | 1.0X10¹ | 2.7X10² | 5.0X10^-1 | 1.4X10¹ | 6.2X10³ | 1.7X10⁵ | | | Pt-197 | | 2.0X10¹ | 5.4X10² | 6.0X10^-1 | 1.6X10¹ | 3.2X10⁴ | 8.7X10⁵ | | | Pt-197m | | 1.0X10¹ | 2.7X10² | 6.0X10^-1 | 1.6X10¹ | 3.7X10⁵ | 1.0X10⁷ | | | Pu-236 | Plutonium (94) | 3.0X10¹ | 8.1X10² | 3.0X10^-3 | 8.1X10^-2 | 2.0X10¹ | 5.3X10² | | | Pu-237 | | 2.0X10¹ | 5.4X10² | 2.0X10¹ | 5.4X10² | 4.5X10² | 1.2X10⁴ | | | Pu-238 | | 1.0X10¹ | 2.7X10² | 1.0X10^-3 | 2.7X10^-2 | 6.3X10^-1 | 1.7X10¹ | | | Pu-239 | | 1.0X10¹ | 2.7X10² | 1.0X10^-3 | 2.7X10^-2 | 2.3X10^-3 | 6.2X10^-2 | | | Pu-240 | | 1.0X10¹ | 2.7X10² | 1.0X10^-3 | 2.7X10^-2 | 8.4X10^-3 | 2.3X10^-1 | | | Pu-241 (a) | | 4.0X10¹ | 1.1X10³ | 6.0X10^-2 | 1.6 | 3.8 | 1.0X10² | | | Pu-242 | | 1.0X10¹ | 2.7X10² | 1.0X10^-3 | 2.7X10^-2 | 1.5X10^-4 | 3.9X10^-3 | | | Pu-244 (a) | | 4.0X10^-1 | 1.1X10¹ | 1.0X10^-3 | 2.7X10^-2 | 6.7X10^-7 | 1.8X10^-5 | | | Ra-223 (a) | Radium (88) | 4.0X10^-1 | 1.1X10¹ | 7.0X10^-3 | 1.9X10^-1 | 1.9X10³ | 5.1X10⁴ | | | Ra-224 (a) | | 4.0X10^-1 | 1.1X10¹ | 2.0X10^-2 | 5.4X10^-1 | 5.9X10³ | 1.6X10⁵ | | | Ra-225 (a) | | 2.0X10^-1 | 5.4 | 4.0X10^-3 | 1.1X10^-1 | 1.5X10³ | 3.9X10⁴ | | | Ra-226 (a) | | 2.0X10^-1 | 5.4 | 3.0X10^-3 | 8.1X10^-2 | 3.7X10^-2 | 1.0 | | | Ra-228 (a) | | 6.0X10^-1 | 1.6X10¹ | 2.0X10^-2 | 5.4X10^-1 | 1.0X10¹ | 2.7X10² | | | Rb-81 | Rubidium (37) | 2.0 | 5.4X10¹ | 8.0X10^-1 | 2.2X10¹ | 3.1X10⁵ | 8.4X10⁶ | | | Rb-83 (a) | | 2.0 | 5.4X10¹ | 2.0 | 5.4X10¹ | 6.8X10² | 1.8X10⁴ | | | Rb-84 | | 1.0 | 2.7X10¹ | 1.0 | 2.7X10¹ | 1.8X10³ | 4.7X10⁴ | | | Rb-86 | | 5.0X10^-1 | 1.4X10¹ | 5.0X10^-1 | 1.4X10¹ | 3.0X10³ | 8.1X10⁴ | | | Rb-87 | | Unlimited | Unlimited | Unlimited | Unlimited | 3.2X10^-9 | 8.6X10^-8 | | | Rb(nat) | | Unlimited | Unlimited | Unlimited | Unlimited | 6.7X10⁶ | 1.8X10⁸ | | | Re-184 | Rhenium (75) | 1.0 | 2.7X10¹ | 1.0 | 2.7X10¹ | 6.9X10² | 1.9X10⁴ | | | Re-184m | | 3.0 | 8.1X10¹ | 1.0 | 2.7X10¹ | 1.6X10² | 4.3X10³ | | | Re-186 | | 2.0 | 5.4X10¹ | 6.0X10^-1 | 1.6X10¹ | 6.9X10³ | 1.9X10⁵ | | | Re-187 | | Unlimited | Unlimited | Unlimited | Unlimited | 1.4X10^-9 | 3.8X10^-8 | | | Re-188 | | 4.0X10^-1 | 1.1X10¹ | 4.0X10^-1 | 1.1X10¹ | 3.6X10⁴ | 9.8X10⁵ | | | Re-189 (a) | | 3.0 | 8.1X10¹ | 6.0X10^-1 | 1.6X10¹ | 2.5X10⁴ | 6.8X10⁵ | | | Re(nat) | | Unlimited | Unlimited | Unlimited | Unlimited | 0.0 | 2.4X10^-8 | | | Rh-99 | Rhodium (45) | 2.0 | 5.4X10¹ | 2.0 | 5.4X10¹ | 3.0X10³ | 8.2X10⁴ | | | Rh-101 | | 4.0 | 1.1X10² | 3.0 | 8.1X10¹ | 4.1X10¹ | 1.1X10³ | | | Rh-102 | | 5.0X10^-1 | 1.4X10¹ | 5.0X10^-1 | 1.4X10¹ | 4.5X10¹ | 1.2X10³ | | | Rh-102m | | 2.0 | 5.4X10¹ | 2.0 | 5.4X10¹ | 2.3X10² | 6.2X10³ | | | Rh-103m | | 4.0X10¹ | 1.1X10³ | 4.0X10¹ | 1.1X10³ | 1.2X10⁶ | 3.3X10⁷ | | | Rh-105 | | 1.0X10¹ | 2.7X10² | 8.0X10^-1 | 2.2X10¹ | 3.1X10⁴ | 8.4X10⁵ | | | Rn-222 (a) | Radon (86) | 3.0X10^-1 | 8.1 | 4.0X10^-3 | 1.1X10^-1 | 5.7X10³ | 1.5X10⁵ | | | Ru-97 | Ruthenium (44) | 5.0 | 1.4X10² | 5.0 | 1.4X10² | 1.7X10⁴ | 4.6X10⁵ | | | Ru-103 (a) | | 2.0 | 5.4X10¹ | 2.0 | 5.4X10¹ | 1.2X10³ | 3.2X10⁴ | | | Ru-105 | | 1.0 | 2.7X10¹ | 6.0X10^-1 | 1.6X10¹ | 2.5X10⁵ | 6.7X10⁶ | | | Ru-106 (a) | | 2.0X10^-1 | 5.4 | 2.0X10^-1 | 5.4 | 1.2X10² | 3.3X10³ | | | S-35 | Sulphur (16) | 4.0X10¹ | 1.1X10³ | 3.0 | 8.1X10¹ | 1.6X10³ | 4.3X10⁴ | | | Sb-122 | Antimony (51) | 4.0X10^-1 | 1.1X10¹ | 4.0X10^-1 | 1.1X10¹ | 1.5X10⁴ | 4.0X10⁵ | | | Sb-124 | | 6.0X10^-1 | 1.6X10¹ | 6.0X10^-1 | 1.6X10¹ | 6.5X10² | 1.7X10⁴ | | | Sb-125 | | 2.0 | 5.4X10¹ | 1.0 | 2.7X10¹ | 3.9X10¹ | 1.0X10³ | | | Sb-126 | | 4.0X10^-1 | 1.1X10¹ | 4.0X10^-1 | 1.1X10¹ | 3.1X10³ | 8.4X10⁴ | | | Sc-44 | Scandium (21) | 5.0X10^-1 | 1.4X10¹ | 5.0X10^-1 | 1.4X10¹ | 6.7X10⁵ | 1.8X10⁷ | | | Sc-46 | | 5.0X10^-1 | 1.4X10¹ | 5.0X10^-1 | 1.4X10¹ | 1.3X10³ | 3.4X10⁴ | | | Sc-47 | | 1.0X10¹ | 2.7X10² | 7.0X10^-1 | 1.9X10¹ | 3.1X10⁴ | 8.3X10⁵ | | | Sc-48 | | 3.0X10^-1 | 8.1 | 3.0X10^-1 | 8.1 | 5.5X10⁴ | 1.5X10⁶ | | | Se-75 | Selenium (34) | 3.0 | 8.1X10¹ | 3.0 | 8.1X10¹ | 5.4X10² | 1.5X10⁴ | | | Se-79 | | 4.0X10¹ | 1.1X10³ | 2.0 | 5.4X10¹ | 2.6X10^-3 | 7.0X10^-2 | | | Si-31 | Silicon (14) | 6.0X10^-1 | 1.6X10¹ | 6.0X10^-1 | 1.6X10¹ | 1.4X10⁶ | 3.9X10⁷ | | | Si-32 | | 4.0X10¹ | 1.1X10³ | 5.0X10^-1 | 1.4X10¹ | 3.9 | 1.1X10² | | | Sm-145 | Samarium (62) | 1.0X10¹ | 2.7X10² | 1.0X10¹ | 2.7X10² | 9.8X10¹ | 2.6X10³ | | | Sm-147 | | Unlimited | Unlimited | Unlimited | Unlimited | 8.5X10^-10 | 2.3X10^-8 | | | Sm-151 | | 4.0X10¹ | 1.1X10³ | 1.0X10¹ | 2.7X10² | 9.7X10^-1 | 2.6X10¹ | | | Sm-153 | | 9.0 | 2.4X10² | 6.0X10^-1 | 1.6X10¹ | 1.6X10⁴ | 4.4X10⁵ | | | Sn-113 (a) | Tin (50) | 4.0 | 1.1X10² | 2.0 | 5.4X10¹ | 3.7X10² | 1.0X10⁴ | | | Sn-117m | | 7.0 | 1.9X10² | 4.0X10^-1 | 1.1X10¹ | 3.0X10³ | 8.2X10⁴ | | | Sn-119m | | 4.0X10¹ | 1.1X10³ | 3.0X10¹ | 8.1X10² | 1.4X10² | 3.7X10³ | | | Sn-121m (a) | | 4.0X10¹ | 1.1X10³ | 9.0X10^-1 | 2.4X10¹ | 2.0 | 5.4X10¹ | | | Sn-123 | | 8.0X10^-1 | 2.2X10¹ | 6.0X10^-1 | 1.6X10¹ | 3.0X10² | 8.2X10³ | | | Sn-125 | | 4.0X10^-1 | 1.1X10¹ | 4.0X10^-1 | 1.1X10¹ | 4.0X10³ | 1.1X10⁵ | | | Sn-126 (a) | | 6.0X10^-1 | 1.6X10¹ | 4.0X10^-1 | 1.1X10¹ | 1.0X10^-3 | 2.8X10^-2 | | | Sr-82 (a) | Strontium (38) | 2.0X10^-1 | 5.4 | 2.0X10^-1 | 5.4 | 2.3X10³ | 6.2X10⁴ | | | Sr-85 | | 2.0 | 5.4X10¹ | 2.0 | 5.4X10¹ | 8.8X10² | 2.4X10⁴ | | | Sr-85m | | 5.0 | 1.4X10² | 5.0 | 1.4X10² | 1.2X10⁶ | 3.3X10⁷ | | | Sr-87m | | 3.0 | 8.1X10¹ | 3.0 | 8.1X10¹ | 4.8X10⁵ | 1.3X10⁷ | | | Sr-89 | | 6.0X10^-1 | 1.6X10¹ | 6.0X10^-1 | 1.6X10¹ | 1.1X10³ | 2.9X10⁴ | | | Sr-90 (a) | | 3.0X10^-1 | 8.1 | 3.0X10^-1 | 8.1 | 5.1 | 1.4X10² | | | Sr-91 (a) | | 3.0X10^-1 | 8.1 | 3.0X10^-1 | 8.1 | 1.3X10⁵ | 3.6X10⁶ | | | Sr-92 (a) | | 1.0 | 2.7X10¹ | 3.0X10^-1 | 8.1 | 4.7X10⁵ | 1.3X10⁷ | | | T(H-3) | Tritium (1) | 4.0X10¹ | 1.1X10³ | 4.0X10¹ | 1.1X10³ | 3.6X10² | 9.7X10³ | | | Ta-178 (long-lived) | Tantalum (73) | 1.0 | 2.7X10¹ | 8.0X10^-1 | 2.2X10¹ | 4.2X10⁶ | 1.1X10⁸ | | | Ta-179 | | 3.0X10¹ | 8.1X10² | 3.0X10¹ | 8.1X10² | 4.1X10¹ | 1.1X10³ | | | Ta-182 | | 9.0X10^-1 | 2.4X10¹ | 5.0X10^-1 | 1.4X10¹ | 2.3X10² | 6.2X10³ | | | Tb-157 | Terbium (65) | 4.0X10¹ | 1.1X10³ | 4.0X10¹ | 1.1X10³ | 5.6X10^-1 | 1.5X10¹ | | | Tb-158 | | 1.0 | 2.7X10¹ | 1.0 | 2.7X10¹ | 5.6X10^-1 | 1.5X10¹ | | | Tb-160 | | 1.0 | 2.7X10¹ | 6.0X10^-1 | 1.6X10¹ | 4.2X10² | 1.1X10⁴ | | | Tc-95m (a) | Technetium (43) | 2.0 | 5.4X10¹ | 2.0 | 5.4X10¹ | 8.3X10² | 2.2X10⁴ | | | Tc-96 | | 4.0X10^-1 | 1.1X10¹ | 4.0X10^-1 | 1.1X10¹ | 1.2X10⁴ | 3.2X10⁵ | | | Tc-96m (a) | | 4.0X10^-1 | 1.1X10¹ | 4.0X10^-1 | 1.1X10¹ | 1.4X10⁶ | 3.8X10⁷ | | | Tc-97 | | Unlimited | Unlimited | Unlimited | Unlimited | 5.2X10^-5 | 1.4X10^-3 | | | Tc-97m | | 4.0X10¹ | 1.1X10³ | 1.0 | 2.7X10¹ | 5.6X10² | 1.5X10⁴ | | | Tc-98 | | 8.0X10^-1 | 2.2X10¹ | 7.0X10^-1 | 1.9X10¹ | 3.2X10^-5 | 8.7X10^-4 | | | Tc-99 | | 4.0X10¹ | 1.1X10³ | 9.0X10^-1 | 2.4X10¹ | 6.3X10^-4 | 1.7X10^-2 | | | Tc-99m | | 1.0X10¹ | 2.7X10² | 4.0 | 1.1X10² | 1.9X10⁵ | 5.3X10⁶ | | | Te-121 | Tellurium (52) | 2.0 | 5.4X10¹ | 2.0 | 5.4X10¹ | 2.4X10³ | 6.4X10⁴ | | | Te-121m | | 5.0 | 1.4X10² | 3.0 | 8.1X10¹ | 2.6X10² | 7.0X10³ | | | Te-123m | | 8.0 | 2.2X10² | 1.0 | 2.7X10¹ | 3.3X10² | 8.9X10³ | | | Te-125m | | 2.0X10¹ | 5.4X10² | 9.0X10^-1 | 2.4X10¹ | 6.7X10² | 1.8X10⁴ | | | Te-127 | | 2.0X10¹ | 5.4X10² | 7.0X10^-1 | 1.9X10¹ | 9.8X10⁴ | 2.6X10⁶ | | | Te-127m (a) | | 2.0X10¹ | 5.4X10² | 5.0X10^-1 | 1.4X10¹ | 3.5X10² | 9.4X10³ | | | Te-129 | | 7.0X10^-1 | 1.9X10¹ | 6.0X10^-1 | 1.6X10¹ | 7.7X10⁵ | 2.1X10⁷ | | | Te-129m (a) | | 8.0X10^-1 | 2.2X10¹ | 4.0X10^-1 | 1.1X10¹ | 1.1X10³ | 3.0X10⁴ | | | Te-131m (a) | | 7.0X10^-1 | 1.9X10¹ | 5.0X10^-1 | 1.4X10¹ | 3.0X10⁴ | 8.0X10⁵ | | | Te-132 (a) | | 5.0X10^-1 | 1.4X10¹ | 4.0X10^-1 | 1.1X10¹ | 1.1X10⁴ | 3.0X10⁵ | | | Th-227 | Thorium (90) | 1.0X10¹ | 2.7X10² | 5.0X10^-3 | 1.4X10^-1 | 1.1X10³ | 3.1X10⁴ | | | Th-228 (a) | | 5.0X10^-1 | 1.4X10¹ | 1.0X10^-3 | 2.7X10^-2 | 3.0X10¹ | 8.2X10² | | | Th-229 | | 5.0 | 1.4X10² | 5.0X10^-4 | 1.4X10^-2 | 7.9X10^-3 | 2.1X10^-1 | | | Th-230 | | 1.0X10¹ | 2.7X10² | 1.0X10^-3 | 2.7X10^-2 | 7.6X10^-4 | 2.1X10^-2 | | | Th-231 | | 4.0X10¹ | 1.1X10³ | 2.0X10^-2 | 5.4X10^-1 | 2.0X10⁴ | 5.3X10⁵ | | | Th-232 | | Unlimited | Unlimited | Unlimited | Unlimited | 4.0X10^-9 | 1.1X10^-7 | | | Th-234 (a) | | 3.0X10^-1 | 8.1 | 3.0X10^-1 | 8.1 | 8.6X10² | 2.3X10⁴ | | | Th(nat) | | Unlimited | Unlimited | Unlimited | Unlimited | 8.1X10^-9 | 2.2X10^-7 | | | Ti-44 (a) | Titanium (22) | 5.0X10^-1 | 1.4X10¹ | 4.0X10^-1 | 1.1X10¹ | 6.4 | 1.7X10² | | | Tl-200 | Thallium (81) | 9.0X10^-1 | 2.4X10¹ | 9.0X10^-1 | 2.4X10¹ | 2.2X10⁴ | 6.0X10⁵ | | | Tl-201 | | 1.0X10¹ | 2.7X10² | 4.0 | 1.1X10² | 7.9X10³ | 2.1X10⁵ | | | Tl-202 | | 2.0 | 5.4X10¹ | 2.0 | 5.4X10¹ | 2.0X10³ | 5.3X10⁴ | | | Tl-204 | | 1.0X10¹ | 2.7X10² | 7.0X10^-1 | 1.9X10¹ | 1.7X10¹ | 4.6X10² | | | Tm-167 | Thulium (69) | 7.0 | 1.9X10² | 8.0X10^-1 | 2.2X10¹ | 3.1X10³ | 8.5X10⁴ | | | Tm-170 | | 3.0 | 8.1X10¹ | 6.0X10^-1 | 1.6X10¹ | 2.2X10² | 6.0X10³ | | | Tm-171 | | 4.0X10¹ | 1.1X10³ | 4.0X10¹ | 1.1X10³ | 4.0X10¹ | 1.1X10³ | | | U-230 (fast lung absorption) (a)(d) | Uranium (92) | 4.0X10¹ | 1.1X10³ | 1.0X10^-1 | 2.7 | 1.0X10³ | 2.7X10⁴ | | | U-230 (medium lung absorption) (a)(e) | | 4.0X10¹ | 1.1X10³ | 4.0X10^-3 | 1.1X10^-1 | 1.0X10³ | 2.7X10⁴ | | | U-230 (slow lung absorption) (a)(f) | | 3.0X10¹ | 8.1X10² | 3.0X10^-3 | 8.1X10^-2 | 1.0X10³ | 2.7X10⁴ | | | U-232 (fast lung absorption) (d) | | 4.0X10¹ | 1.1X10³ | 1.0X10^-2 | 2.7X10^-1 | 8.3X10^-1 | 2.2X10¹ | | | U-232 (medium lung absorption) (e) | | 4.0X10¹ | 1.1X10³ | 7.0X10^-3 | 1.9X10^-1 | 8.3X10^-1 | 2.2X10¹ | | | U-232 (slow lung absorption) (f) | | 1.0X10¹ | 2.7X10² | 1.0X10^-3 | 2.7X10^-2 | 8.3X10^-1 | 2.2X10¹ | | | U-233 (fast lung absorption) (d) | | 4.0X10¹ | 1.1X10³ | 9.0X10^-2 | 2.4 | 3.6X10^-4 | 9.7X10^-3 | | | U-233 (medium lung absorption) (e) | | 4.0X10¹ | 1.1X10³ | 2.0X10^-2 | 5.4X10^-1 | 3.6X10^-4 | 9.7X10^-3 | | | U-233 (slow lung absorption) (f) | | 4.0X10¹ | 1.1X10³ | 6.0X10^-3 | 1.6X10^-1 | 3.6X10^-4 | 9.7X10^-3 | | | U-234 (fast lung absorption) (d) | | 4.0X10¹ | 1.1X10³ | 9.0X10^-2 | 2.4 | 2.3X10^-4 | 6.2X10^-3 | | | U-234 (medium lung absorption) (e) | | 4.0X10¹ | 1.1X10³ | 2.0X10^-2 | 5.4X10^-1 | 2.3X10^-4 | 6.2X10^-3 | | | U-234 (slow lung absorption) (f) | | 4.0X10¹ | 1.1X10³ | 6.0X10^-3 | 1.6X10^-1 | 2.3X10^-4 | 6.2X10^-3 | | | U-235 (all lung absorption types) (a),(d),(e),(f) | | Unlimited | Unlimited | Unlimited | Unlimited | 8.0X10^-8 | 2.2X10^-6 | | | U-236 (fast lung absorption) (d) | | Unlimited | Unlimited | Unlimited | Unlimited | 2.4X10^-6 | 6.5X10^-5 | | | U-236 (medium lung absorption) (e) | | 4.0X10¹ | 1.1X10³ | 2.0X10^-2 | 5.4X10^-1 | 2.4X10^-6 | 6.5X10^-5 | | | U-236 (slow lung absorption) (f) | | 4.0X10¹ | 1.1X10³ | 6.0X10^-3 | 1.6X10^-1 | 2.4X10^-6 | 6.5X10^-5 | | | U-238 (all lung absorption types) (d),(e),(f) | | Unlimited | Unlimited | Unlimited | Unlimited | 1.2X10^-8 | 3.4X10^-7 | | | U (nat) | | Unlimited | Unlimited | Unlimited | Unlimited | 2.6X10^-8 | 7.1X10^-7 | | | U (enriched to 20% or less) (g) | | Unlimited | Unlimited | Unlimited | Unlimited | See Table A-4 | See Table A-4 | | | U (dep) | | Unlimited | Unlimited | Unlimited | Unlimited | See Table A-4 | See Table A-3 | | | V-48 | Vanadium (23) | 4.0X10^-1 | 1.1X10¹ | 4.0X10^-1 | 1.1X10¹ | 6.3X10³ | 1.7X10⁵ | | | V-49 | | 4.0X10¹ | 1.1X10³ | 4.0X10¹ | 1.1X10³ | 3.0X10² | 8.1X10³ | | | W-178 (a) | Tungsten (74) | 9.0 | 2.4X10² | 5.0 | 1.4X10² | 1.3X10³ | 3.4X10⁴ | | | W-181 | | 3.0X10¹ | 8.1X10² | 3.0X10¹ | 8.1X10² | 2.2X10² | 6.0X10³ | | | W-185 | | 4.0X10¹ | 1.1X10³ | 8.0X10^-1 | 2.2X10¹ | 3.5X10² | 9.4X10³ | | | W-187 | | 2.0 | 5.4X10¹ | 6.0X10^-1 | 1.6X10¹ | 2.6X10⁴ | 7.0X10⁵ | | | W-188 (a) | | 4.0X10^-1 | 1.1X10¹ | 3.0X10^-1 | 8.1 | 3.7X10² | 1.0X10⁴ | | | Xe-122 (a) | Xenon (54) | 4.0X10^-1 | 1.1X10¹ | 4.0X10^-1 | 1.1X10¹ | 4.8X10⁴ | 1.3X10⁶ | | | Xe-123 | | 2.0 | 5.4X10¹ | 7.0X10^-1 | 1.9X10¹ | 4.4X10⁵ | 1.2X10 | | | Xe-127 | | 4.0 | 1.1X10² | 2.0 | 5.4X10¹ | 1.0X10³ | 2.8X10⁴ | | | Xe-131m | | 4.0X10¹ | 1.1X10³ | 4.0X10¹ | 1.1X10³ | 3.1X10³ | 8.4X10⁴ | | | Xe-133 | | 2.0X10¹ | 5.4X10² | 1.0X10¹ | 2.7X10² | 6.9X10³ | 1.9X10⁵ | | | Xe-135 | | 3.0 | 8.1X10¹ | 2.0 | 5.4X10¹ | 9.5X10⁴ | 2.6X10⁶ | | | Y-87 (a) | Yttrium (39) | 1.0 | 2.7X10¹ | 1.0 | 2.7X10¹ | 1.7X10⁴ | 4.5X10⁵ | | | Y-88 | | 4.0X10^-1 | 1.1X10¹ | 4.0X10^-1 | 1.1X10¹ | 5.2X10² | 1.4X10⁴ | | | Y-90 | | 3.0X10^-1 | 8.1 | 3.0X10^-1 | 8.1 | 2.0X10⁴ | 5.4X10⁵ | | | Y-91 | | 6.0X10^-1 | 1.6X10¹ | 6.0X10^-1 | 1.6X10¹ | 9.1X10² | 2.5X10⁴ | | | Y-91m | | 2.0 | 5.4X10¹ | 2.0 | 5.4X10¹ | 1.5X10⁶ | 4.2X10 | | | Y-92 | | 2.0X10^-1 | 5.4 | 2.0X10^-1 | 5.4 | 3.6X10⁵ | 9.6X10⁶ | | | Y-93 | | 3.0X10^-1 | 8.1 | 3.0X10^-1 | 8.1 | 1.2X10⁵ | 3.3X10⁶ | | | Yb-169 | Ytterbium (70) | 4.0 | 1.1X10² | 1.0 | 2.7X10¹ | 8.9X10² | 2.4X10⁴ | | | Yb-175 | | 3.0X10¹ | 8.1X10² | 9.0X10^-1 | 2.4X10¹ | 6.6X10³ | 1.8X10⁵ | | | Zn-65 | Zinc (30) | 2.0 | 5.4X10¹ | 2.0 | 5.4X10¹ | 3.0X10² | 8.2X10³ | | | Zn-69 | | 3.0 | 8.1X10¹ | 6.0X10^-1 | 1.6X10¹ | 1.8X10⁶ | 4.9X10 | | | Zn-69m (a) | | 3.0 | 8.1X10¹ | 6.0X10^-1 | 1.6X10¹ | 1.2X10⁵ | 3.3X10⁶ | | | Zr-88 | Zirconium (40) | 3.0 | 8.1X10¹ | 3.0 | 8.1X10¹ | 6.6X10² | 1.8X10⁴ | | | Zr-93 | | Unlimited | Unlimited | Unlimited | Unlimited | 9.3X10 | 2.5X10 | | | Zr-95 (a) | | 2.0 | 5.4X10¹ | 8.0X10^-1 | 2.2X10¹ | 7.9X10² | 2.1X10⁴ | | | Zr-97 (a) | | 4.0X10^-1 | 1.1X10¹ | 4.0X10^-1 | 1.1X10¹ | 7.1X10⁴ | 1.9X10⁶ | | | ^aA₁ and/or A₂ values include contributions from daughter nuclides with half-lives less than 10 days, as listed in the following: | | | | | | | | | | Mg-28 Ca-47 Ti-44 Fe-52 Fe-60 Zn-69m Ge-68 Rb-83 Sr-82 Sr-90 Sr-91 Sr-92 Y-87 Zr-95 Zr-97 Mo-99 Tc-95m Tc-96m Ru-103 Ru-106 Pd-103 Ag-108m Ag-110m Cd-115 In-114m Sn-113 Sn-121m Sn-126 Te-127m Te-129m Te-131m Te-132 I-135 Xe-122 Cs-137 Ba-131 Ba-140 Ce-144 Pm-148m Gd-146 Dy-166 Hf-172 W-178 W-188 Re-189 Os-194 Ir-189 Pt-188 Hg-194 Hg-195m Pb-210 Pb-212 Bi-210m Bi-212 At-211 Rn-222 Ra-223 Ra-224 Ra-225 Ra-228 Ac-225 Ac-227 Th-228 Th-234 Pa-230 U-230 U-235 Pu-241 Pu-244 Am-242m Am-243 Cm-247 Bk-249 Cf-253 | Al-28 Sc-47 Sc-44 Mn-52m Co-60m Zn-69 Ga-68 Kr-83m Rb-82 Y-90 Y-91m Y-92 Sr-87m Nb-95m Nb-97m, Nb-97 Tc-99m Tc-95 Tc-96 Rh-103m Rh-106 Rh-103m Ag-108 Ag-110 In-115m In-114 In-113m Sn-121 Sb-126m Te-127 Te-129 Te-131 I-132 Xe-135m I-122 Ba-137m Cs-131 La-140 Pr-144m, Pr-144 Pm-148 Eu-146 Ho-166 Lu-172 Ta-178 Re-188 Os-189m Ir-194 Os-189m Ir-188 Au-194 Hg-195 Bi-210 Bi-212, Po-212, TI-208 Tl-206 Tl-208, Po-212 Po-211 Po-218, Pb-214, At-218, Bi-214, Po-214 Rn-219, Po-215, Pb-211, Bi-211, Po-211, Tl-207 Rn-220, Po-216, Pb-212, Bi-212, Tl-208, Po-212 Ac-225, Fr-221, At-217, Bi-213, Tl-209, Po-213, Pb-209 Ac-228 Fr-221, At-217, Bi-213, Po-213, Pb-209, TI-209 Fr-223 Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208, Po-212 Pa-234m, Pa-234 Ac-226, Th-226, Fr-222, Ra-222, Rn-218, Po-214 Th-226, Ra-222, Rn-218, Po-214 Th-231 U-237 U-240, Np-240m Am-242, Np-238 Np-239 Pu-243 Am-245 Cm-249 | | | | | | | | | ^bThe values of A₁ and A₂ in Curies (Ci) are approximate and for information only; the regulatory standard units are terabecquerels (TBq). ^cThe activity of Ir-192 in special form may be determined from a measurement of the rate of decay or a measurement of the radiation level at a prescribed distance from the source. ^dThese values apply only to compounds of uranium that take the chemical form of UF₆, UO₂F₂ and UO₂(NO₃)₂ in both normal and accident conditions of transport. ^eThese values apply only to compounds of uranium that take the chemical form of UO₃, UF₄, UCl₄ and hexavalent compounds in both normal and accident conditions of transport. ^fThese values apply to all compounds of uranium other than those specified in notes d and e of this table. ^gThese values apply to unirradiated uranium only. ^h A₂ = 0.74 TBq (20 Ci) for Mo-99 for domestic use. | | | | | | | | | | | | | | | | | | |

G. Table 2. Exempt Material Activity Concentrations and Exempt Consignment Activity Limits for Radionuclides.

| Symbol of radionuclide | Element and atomic number | Activity concentration for exempt material (Bq/g) | Activity concentration for exempt material (Ci/g) | Activity limit for exempt consignment (Bq) | Activity limit for exempt consignment (Ci) | | --- | --- | --- | --- | --- | --- | | Ac-225 | Actinium (89) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁴ | 2.7X10^-7 | | Ac-227 | | 1.0X10^-1 | 2.7X10^-12 | 1.0X10³ | 2.7X10^-8 | | Ac-228 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Ag-105 | Silver (47) | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Ag-108m (b) | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Ag-110m | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Ag-111 | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁶ | 2.7X10^-5 | | Al-26 | Aluminum (13) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | Am-241 | Americium (95) | 1.0 | 2.7X10^-11 | 1.0X10⁴ | 2.7X10^-7 | | Am-242m (b) | | 1.0 | 2.7X10^-11 | 1.0X10⁴ | 2.7X10^-7 | | Am-243 (b) | | 1.0 | 2.7X10^-11 | 1.0X10³ | 2.7X10^-8 | | Ar-37 | Argon (18) | 1.0X10⁶ | 2.7X10^-5 | 1.0X10⁸ | 2.7X10^-3 | | Ar-39 | | 1.0X10⁷ | 2.7X10^-4 | 1.0X10⁴ | 2.7X10^-7 | | Ar-41 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁹ | 2.7X10^-2 | | As-72 | Arsenic (33) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | As-73 | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁷ | 2.7X10^-4 | | As-74 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | As-76 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁵ | 2.7X10^-6 | | As-77 | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁶ | 2.7X10^-5 | | At-211 | Astatine (85) | 1.0X10³ | 2.7X10^-8 | 1.0X10⁷ | 2.7X10^-4 | | Au-193 | Gold (79) | 1.0X10² | 2.7X10^-9 | 1.0X10⁷ | 2.7X10^-4 | | Au-194 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Au-195 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁷ | 2.7X10^-4 | | Au-198 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Au-199 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Ba-131 | Barium (56) | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Ba-133 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Ba-133m | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Ba-140 (b) | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | Be-7 | Beryllium (4) | 1.0X10³ | 2.7X10^-8 | 1.0X10⁷ | 2.7X10^-4 | | Be-10 | | 1.0X10⁴ | 2.7X10^-7 | 1.0X10⁶ | 2.7X10^-5 | | Bi-205 | Bismuth (83) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Bi-206 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | Bi-207 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Bi-210 | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁶ | 2.7X10^-5 | | Bi-210m | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | Bi-212 (b) | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | Bk-247 | Berkelium (97) | 1.0 | 2.7X10^-11 | 1.0X10⁴ | 2.7X10^-7 | | Bk-249 | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁶ | 2.7X10^-5 | | Br-76 | Bromine (35) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | Br-77 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Br-82 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | C-11 | Carbon (6) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | C-14 | | 1.0X10⁴ | 2.7X10^-7 | 1.0X10⁷ | 2.7X10^-4 | | Ca-41 | Calcium (20) | 1.0X10⁵ | 2.7X10^-6 | 1.0X10⁷ | 2.7X10^-4 | | Ca-45 | | 1.0X10⁴ | 2.7X10^-7 | 1.0X10⁷ | 2.7X10^-4 | | Ca-47 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Cd-109 | Cadmium (48) | 1.0X10⁴ | 2.7X10^-7 | 1.0X10⁶ | 2.7X10^-5 | | Cd-113m | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁶ | 2.7X10^-5 | | Cd-115 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Cd-115m | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁶ | 2.7X10^-5 | | Ce-139 | Cerium (58) | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Ce-141 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁷ | 2.7X10^-4 | | Ce-143 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Ce-144 (b) | | 1.0X10² | 2.7X10^-9 | 1.0X10⁵ | 2.7X10^-6 | | Cf-248 | Californium (98) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁴ | 2.7X10^-7 | | Cf-249 | | 1.0 | 2.7X10^-11 | 1.0X10³ | 2.7X10^-8 | | Cf-250 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁴ | 2.7X10^-7 | | Cf-251 | | 1.0 | 2.7X10^-11 | 1.0X10³ | 2.7X10^-8 | | Cf-252 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁴ | 2.7X10^-7 | | Cf-253 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁵ | 2.7X10^-6 | | Cf-254 | | 1.0 | 2.7X10^-11 | 1.0X10³ | 2.7X10^-8 | | Cl-36 | Chlorine (17) | 1.0X10⁴ | 2.7X10^-7 | 1.0X10⁶ | 2.7X10^-5 | | Cl-38 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | Cm-240 | Curium (96) | 1.0X10² | 2.7X10^-9 | 1.0X10⁵ | 2.7X10^-6 | | Cm-241 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Cm-242 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁵ | 2.7X10^-6 | | Cm-243 | | 1.0 | 2.7X10^-11 | 1.0X10⁴ | 2.7X10^-7 | | Cm-244 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁴ | 2.7X10^-7 | | Cm-245 | | 1.0 | 2.7X10^-11 | 1.0X10³ | 2.7X10^-8 | | Cm-246 | | 1.0 | 2.7X10^-11 | 1.0X10³ | 2.7X10^-8 | | Cm-247 | | 1.0 | 2.7X10^-11 | 1.0X10⁴ | 2.7X10^-7 | | Cm-248 | | 1.0 | 2.7X10^-11 | 1.0X10³ | 2.7X10^-8 | | Co-55 | Cobalt (27) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Co-56 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | Co-57 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Co-58 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Co-58m | | 1.0X10⁴ | 2.7X10^-7 | 1.0X10⁷ | 2.7X10^-4 | | Co-60 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | Cr-51 | Chromium (24) | 1.0X10³ | 2.7X10^-8 | 1.0X10⁷ | 2.7X10^-4 | | Cs-129 | Cesium (55) | 1.0X10² | 2.7X10^-9 | 1.0X10⁵ | 2.7X10^-6 | | Cs-131 | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁶ | 2.7X10^-5 | | Cs-132 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | Cs-134 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁴ | 2.7X10^-7 | | Cs-134m | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁵ | 2.7X10^-6 | | Cs-135 | | 1.0X10⁴ | 2.7X10^-7 | 1.0X10⁷ | 2.7X10^-4 | | Cs-136 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | Cs-137 (b) | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁴ | 2.7X10^-7 | | Cu-64 | Copper (29) | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Cu-67 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Dy-159 | Dysprosium (66) | 1.0X10³ | 2.7X10^-8 | 1.0X10⁷ | 2.7X10^-4 | | Dy-165 | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁶ | 2.7X10^-5 | | Dy-166 | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁶ | 2.7X10^-5 | | Er-169 | Erbium (68) | 1.0X10⁴ | 2.7X10^-7 | 1.0X10⁷ | 2.7X10^-4 | | Er-171 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Eu-147 | Europium (63) | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Eu-148 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Eu-149 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁷ | 2.7X10^-4 | | Eu-150 (short lived) | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁶ | 2.7X10^-5 | | Eu-150 (long lived) | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Eu-152 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Eu-152m | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Eu-154 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Eu-155 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁷ | 2.7X10^-4 | | Eu-156 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | F-18 | Fluorine (9) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Fe-52 | Iron (26) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Fe-55 | | 1.0X10⁴ | 2.7X10^-7 | 1.0X10⁶ | 2.7X10^-5 | | Fe-59 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Fe-60 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁵ | 2.7X10^-6 | | Ga-67 | Gallium (31) | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Ga-68 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | Ga-72 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | Gd-146 | Gadolinium (64) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Gd-148 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁴ | 2.7X10^-7 | | Gd-153 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁷ | 2.7X10^-4 | | Gd-159 | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁶ | 2.7X10^-5 | | Ge-68 | Germanium (32) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | Ge-71 | | 1.0X10⁴ | 2.7X10^-7 | 1.0X10⁸ | 2.7X10^-3 | | Ge-77 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | Hf-172 | Hafnium (72) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Hf-175 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Hf-181 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Hf-182 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Hg-194 | Mercury (80) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Hg-195m | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Hg-197 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁷ | 2.7X10^-4 | | Hg-197m | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Hg-203 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁵ | 2.7X10^-6 | | Ho-166 | Holmium (67) | 1.0X10³ | 2.7X10^-8 | 1.0X10⁵ | 2.7X10^-6 | | Ho-166m | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | I-123 | Iodine (53) | 1.0X10² | 2.7X10^-9 | 1.0X10⁷ | 2.7X10^-4 | | I-124 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | I-125 | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁶ | 2.7X10^-5 | | I-126 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | I-129 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁵ | 2.7X10^-6 | | I-131 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | I-132 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | I-133 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | I-134 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | I-135 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | In-111 | Indium (49) | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | In-113m | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | In-114m | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | In-115m | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Ir-189 | Iridium (77) | 1.0X10² | 2.7X10^-9 | 1.0X10⁷ | 2.7X10^-4 | | Ir-190 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Ir-192 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁴ | 2.7X10^-7 | | Ir-194 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁵ | 2.7X10^-6 | | K-40 | Potassium (19) | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | K-42 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | K-43 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Kr-79 | Krypton (36) | 1.0X10³ | 2.7X10^-8 | 1.0X10⁵ | 2.7X10^-6 | | Kr-81 | | 1.0X10⁴ | 2.7X10^-7 | 1.0X10⁷ | 2.7X10^-4 | | Kr-85 | | 1.0X10⁵ | 2.7X10^-6 | 1.0X10⁴ | 2.7X10^-7 | | Kr-85m | | 1.0X10³ | 2.7X10^-8 | 1.0X10¹⁰ | 2.7X10^-1 | | Kr-87 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁹ | 2.7X10^-2 | | La-137 | Lanthanum (57) | 1.0X10³ | 2.7X10^-8 | 1.0X10⁷ | 2.7X10^-4 | | La-140 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | Lu-172 | Lutetium (71) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Lu-173 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁷ | 2.7X10^-4 | | Lu-174 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁷ | 2.7X10^-4 | | Lu-174m | | 1.0X10² | 2.7X10^-9 | 1.0X10⁷ | 2.7X10^-4 | | Lu-177 | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁷ | 2.7X10^-4 | | Mg-28 | Magnesium (12) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | Mn-52 | Manganese (25) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | Mn-53 | | 1.0X10⁴ | 2.7X10^-7 | 1.0X10⁹ | 2.7X10^-2 | | Mn-54 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Mn-56 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | Mo-93 | Molybdenum (42) | 1.0X10³ | 2.7X10^-8 | 1.0X10⁸ | 2.7X10^-3 | | Mo-99 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | N-13 | Nitrogen (7) | 1.0X10² | 2.7X10^-9 | 1.0X10⁹ | 2.7X10^-2 | | Na-22 | Sodium (11) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Na-24 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | Nb-93m | Niobium (41) | 1.0X10⁴ | 2.7X10^-7 | 1.0X10⁷ | 2.7X10^-4 | | Nb-94 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Nb-95 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Nb-97 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Nd-147 | Neodymium (60) | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Nd-149 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Ni-59 | Nickel (28) | 1.0X10⁴ | 2.7X10^-7 | 1.0X10⁸ | 2.7X10^-3 | | Ni-63 | | 1.0X10⁵ | 2.7X10^-6 | 1.0X10⁸ | 2.7X10^-3 | | Ni-65 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Np-235 | Neptunium (93) | 1.0X10³ | 2.7X10^-8 | 1.0X10⁷ | 2.7X10^-4 | | Np-236 (short-lived) | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁷ | 2.7X10^-4 | | Np-236 (long-lived) | | 1.0X10² | 2.7X10^-9 | 1.0X10⁵ | 2.7X10^-6 | | Np-237 (b) | | 1.0 | 2.7X10^-11 | 1.0X10³ | 2.7X10^-8 | | Np-239 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁷ | 2.7X10^-4 | | Os-185 | Osmium (76) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Os-191 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁷ | 2.7X10^-4 | | Os-191m | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁷ | 2.7X10^-4 | | Os-193 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Os-194 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁵ | 2.7X10^-6 | | P-32 | Phosphorus (15) | 1.0X10³ | 2.7X10^-8 | 1.0X10⁵ | 2.7X10^-6 | | P-33 | | 1.0X10⁵ | 2.7X10^-6 | 1.0X10⁸ | 2.7X10^-3 | | Pa-230 | Protactinium (91) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Pa-231 | | 1.0 | 2.7X10^-11 | 1.0X10³ | 2.7X10^-8 | | Pa-233 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁷ | 2.7X10^-4 | | Pb-201 | Lead (82) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Pb-202 | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁶ | 2.7X10^-5 | | Pb-203 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Pb-205 | | 1.0X10⁴ | 2.7X10^-7 | 1.0X10⁷ | 2.7X10^-4 | | Pb-210 (b) | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁴ | 2.7X10^-7 | | Pb-212 (b) | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | Pd-103 | Palladium (46) | 1.0X10³ | 2.7X10^-8 | 1.0X10⁸ | 2.7X10^-3 | | Pd-107 | | 1.0X10⁵ | 2.7X10^-6 | 1.0X10⁸ | 2.7X10^-3 | | Pd-109 | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁶ | 2.7X10^-5 | | Pm-143 | Promethium (61) | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Pm-144 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Pm-145 | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁷ | 2.7X10^-4 | | Pm-147 | | 1.0X10⁴ | 2.7X10^-7 | 1.0X10⁷ | 2.7X10^-4 | | Pm-148m | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Pm-149 | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁶ | 2.7X10^-5 | | Pm-151 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Po-210 | Polonium (84) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁴ | 2.7X10^-7 | | Pr-142 | Praseodymium (59) | 1.0X10² | 2.7X10^-9 | 1.0X10⁵ | 2.7X10^-6 | | Pr-143 | | 1.0X10⁴ | 2.7X10^-7 | 1.0X10⁶ | 2.7X10^-5 | | Pt-188 | Platinum (78) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Pt-191 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Pt-193 | | 1.0X10⁴ | 2.7X10^-7 | 1.0X10⁷ | 2.7X10^-4 | | Pt-193m | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁷ | 2.7X10^-4 | | Pt-195m | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Pt-197 | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁶ | 2.7X10^-5 | | Pt-197m | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Pu-236 | Plutonium (94) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁴ | 2.7X10^-7 | | Pu-237 | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁷ | 2.7X10^-4 | | Pu-238 | | 1.0 | 2.7X10^-11 | 1.0X10⁴ | 2.7X10^-7 | | Pu-239 | | 1.0 | 2.7X10^-11 | 1.0X10⁴ | 2.7X10^-7 | | Pu-240 | | 1.0 | 2.7X10^-11 | 1.0X10³ | 2.7X10^-8 | | Pu-241 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁵ | 2.7X10^-6 | | Pu-242 | | 1.0 | 2.7X10^-11 | 1.0X10⁴ | 2.7X10^-7 | | Pu-244 | | 1.0 | 2.7X10^-11 | 1.0X10⁴ | 2.7X10^-7 | | Ra-223 (b) | Radium (88) | 1.0X10² | 2.7X10^-9 | 1.0X10⁵ | 2.7X10^-6 | | Ra-224 (b) | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | Ra-225 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁵ | 2.7X10^-6 | | Ra-226 (b) | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁴ | 2.7X10^-7 | | Ra-228 (b) | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | Rb-81 | Rubidium (37) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Rb-83 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Rb-84 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Rb-86 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁵ | 2.7X10^-6 | | Rb-87 | | 1.0X10⁴ | 2.7X10^-7 | 1.0X10⁷ | 2.7X10^-4 | | Rb(nat) | | 1.0X10⁴ | 2.7X10^-7 | 1.0X10⁷ | 2.7X10^-4 | | Re-184 | Rhenium (75) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Re-184m | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Re-186 | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁶ | 2.7X10^-5 | | Re-187 | | 1.0X10⁶ | 2.7X10^-5 | 1.0X10⁹ | 2.7X10^-2 | | Re-188 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁵ | 2.7X10^-6 | | Re-189 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Re(nat) | | 1.0X10⁶ | 2.7X10^-5 | 1.0X10⁹ | 2.7X10^-2 | | Rh-99 | Rhodium (45) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Rh-101 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁷ | 2.7X10^-4 | | Rh-102 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Rh-102m | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Rh-103m | | 1.0X10⁴ | 2.7X10^-7 | 1.0X10⁸ | 2.7X10^-3 | | Rh-105 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁷ | 2.7X10^-4 | | Rn-222 (b) | Radon (86) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁸ | 2.7X10^-3 | | Ru-97 | Ruthenium (44) | 1.0X10² | 2.7X10^-9 | 1.0X10⁷ | 2.7X10^-4 | | Ru-103 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Ru-105 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Ru-106 (b) | | 1.0X10² | 2.7X10^-9 | 1.0X10⁵ | 2.7X10^-6 | | S-35 | Sulphur (16) | 1.0X10⁵ | 2.7X10^-6 | 1.0X10⁸ | 2.7X10^-3 | | Sb-122 | Antimony (51) | 1.0X10² | 2.7X10^-9 | 1.0X10⁴ | 2.7X10^-7 | | Sb-124 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Sb-125 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Sb-126 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | Sc-44 | Scandium (21) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | Sc-46 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Sc-47 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Sc-48 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | Se-75 | Selenium (34) | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Se-79 | | 1.0X10⁴ | 2.7X10^-7 | 1.0X10⁷ | 2.7X10^-4 | | Si-31 | Silicon (14) | 1.0X10³ | 2.7X10^-8 | 1.0X10⁶ | 2.7X10^-5 | | Si-32 | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁶ | 2.7X10^-5 | | Sm-145 | Samarium (62) | 1.0X10² | 2.7X10^-9 | 1.0X10⁷ | 2.7X10^-4 | | Sm-147 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁴ | 2.7X10^-7 | | Sm-151 | | 1.0X10⁴ | 2.7X10^-7 | 1.0X10⁸ | 2.7X10^-3 | | Sm-153 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Sn-113 | Tin (50) | 1.0X10³ | 2.7X10^-8 | 1.0X10⁷ | 2.7X10^-4 | | Sn-117m | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Sn-119m | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁷ | 2.7X10^-4 | | Sn-121m | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁷ | 2.7X10^-4 | | Sn-123 | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁶ | 2.7X10^-5 | | Sn-125 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁵ | 2.7X10^-6 | | Sn-126 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | Sr-82 | Strontium (38) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | Sr-85 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Sr-85m | | 1.0X10² | 2.7X10^-9 | 1.0X10⁷ | 2.7X10^-4 | | Sr-87m | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Sr-89 | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁶ | 2.7X10^-5 | | Sr-90 (b) | | 1.0X10² | 2.7X10^-9 | 1.0X10⁴ | 2.7X10^-7 | | Sr-91 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | Sr-92 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | T(H-3) | Tritium (1) | 1.0X10⁶ | 2.7X10^-5 | 1.0X10⁹ | 2.7X10^-2 | | Ta-178 (long-lived) | Tantalum (73) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Ta-179 | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁷ | 2.7X10^-4 | | Ta-182 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁴ | 2.7X10^-7 | | Tb-157 | Terbium (65) | 1.0X10⁴ | 2.7X10^-7 | 1.0X10⁷ | 2.7X10^-4 | | Tb-158 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Tb-160 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Tc-95m | Technetium (43) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Tc-96 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Tc-96m | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁷ | 2.7X10^-4 | | Tc-97 | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁸ | 2.7X10^-3 | | Tc-97m | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁷ | 2.7X10^-4 | | Tc-98 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Tc-99 | | 1.0X10⁴ | 2.7X10^-7 | 1.0X10⁷ | 2.7X10^-4 | | Tc-99m | | 1.0X10² | 2.7X10^-9 | 1.0X10⁷ | 2.7X10^-4 | | Te-121 | Tellurium (52) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Te-121m | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Te-123m | | 1.0X10² | 2.7X10^-9 | 1.0X10⁷ | 2.7X10^-4 | | Te-125m | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁷ | 2.7X10^-4 | | Te-127 | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁶ | 2.7X10^-5 | | Te-127m | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁷ | 2.7X10^-4 | | Te-129 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Te-129m | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁶ | 2.7X10^-5 | | Te-131m | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Te-132 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁷ | 2.7X10^-4 | | Th-227 | Thorium (90) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁴ | 2.7X10^-7 | | Th-228 (b) | | 1.0 | 2.7X10^-11 | 1.0X10⁴ | 2.7X10^-7 | | Th-229 (b) | | 1.0 | 2.7X10^-11 | 1.0X10³ | 2.7X10^-8 | | Th-230 | | 1.0 | 2.7X10^-11 | 1.0X10⁴ | 2.7X10^-7 | | Th-231 | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁷ | 2.7X10^-4 | | Th-232 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁴ | 2.7X10^-7 | | Th-234 (b) | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁵ | 2.7X10^-6 | | Th (nat) (b) | | 1.0 | 2.7X10^-11 | 1.0X10³ | 2.7X10^-8 | | Ti-44 | Titanium (22) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | Tl-200 | Thallium (81) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Tl-201 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Tl-202 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Tl-204 | | 1.0X10⁴ | 2.7X10^-7 | 1.0X10⁴ | 2.7X10^-7 | | Tm-167 | Thulium (69) | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Tm-170 | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁶ | 2.7X10^-5 | | Tm-171 | | 1.0X10⁴ | 2.7X10^-7 | 1.0X10⁸ | 2.7X10^-3 | | U-230 (fast lung absorption) (b),(d) | Uranium (92) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | U-230 (medium lung absorption) (e) | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁴ | 2.7X10^-7 | | U-230 (slow lung absorption) (f) | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁴ | 2.7X10^-7 | | U-232 (fast lung absorption) (b),(d) | | 1.0 | 2.7X10^-11 | 1.0X10³ | 2.7X10^-8 | | U-232 (medium lung absorption) (e) | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁴ | 2.7X10^-7 | | U-232 (slow lung absorption) (f) | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁴ | 2.7X10^-7 | | U-233 (fast lung absorption) (d) | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁴ | 2.7X10^-7 | | U-233 (medium lung absorption) (e) | | 1.0X10² | 2.7X10^-9 | 1.0X10⁵ | 2.7X10^-6 | | U-233 (slow lung absorption) (f) | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | U-234 (fast lung absorption) (d) | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁴ | 2.7X10^-7 | | U-234 (medium lung absorption) (e) | | 1.0X10² | 2.7X10^-9 | 1.0X10⁵ | 2.7X10^-6 | | U-234 (slow lung absorption) (f) | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | U-235 (all lung absorption types) (b),(d),(e),(f) | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁴ | 2.7X10^-7 | | U-236 (fast lung absorption) (d) | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁴ | 2.7X10^-7 | | U-236 (medium lung absorption) (e) | | 1.0X10² | 2.7X10^-9 | 1.0X10⁵ | 2.7X10^-6 | | U-236 (slow lung absorption) (f) | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁴ | 2.7X10^-7 | | U-238 (all lung absorption types) (b),(d),(e),(f) | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁴ | 2.7X10^-7 | | U (nat) (b) | | 1.0 | 2.7X10^-11 | 1.0X10³ | 2.7X10^-8 | | U (enriched to 20% or less) (g) | | 1.0 | 2.7X10^-11 | 1.0X10³ | 2.7X10^-8 | | U (dep) | | 1.0 | 2.7X10^-11 | 1.0X10³ | 2.7X10^-8 | | V-48 | Vanadium (23) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | V-49 | | 1.0X10⁴ | 2.7X10^-7 | 1.0X10⁷ | 2.7X10^-4 | | W-178 | Tungsten (74) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | W-181 | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁷ | 2.7X10^-4 | | W-185 | | 1.0X10⁴ | 2.7X10^-7 | 1.0X10⁷ | 2.7X10^-4 | | W-187 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | W-188 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁵ | 2.7X10^-6 | | Xe-122 | Xenon (54) | 1.0X10² | 2.7X10^-9 | 1.0X10⁹ | 2.7X10^-2 | | Xe-123 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁹ | 2.7X10^-2 | | Xe-127 | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁵ | 2.7X10^-6 | | Xe-131m | | 1.0X10⁴ | 2.7X10^-7 | 1.0X10⁴ | 2.7X10^-7 | | Xe-133 | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁴ | 2.7X10^-7 | | Xe-135 | | 1.0X10³ | 2.7X10^-8 | 1.0X10¹⁰ | 2.7X10^-1 | | Y-87 | Yttrium (39) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Y-88 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Y-90 | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁵ | 2.7X10^-6 | | Y-91 | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁶ | 2.7X10^-5 | | Y-91m | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Y-92 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁵ | 2.7X10^-6 | | Y-93 | | 1.0X10² | 2.7X10^-9 | 1.0X10⁵ | 2.7X10^-6 | | Yb-169 | Ytterbium (70) | 1.0X10² | 2.7X10^-9 | 1.0X10⁷ | 2.7X10^-4 | | Yb-175 | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁷ | 2.7X10^-4 | | Zn-65 | Zinc (30) | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Zn-69 | | 1.0X10⁴ | 2.7X10^-7 | 1.0X10⁶ | 2.7X10^-5 | | Zn-69m | | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Zr-88 | Zirconium (40) | 1.0X10² | 2.7X10^-9 | 1.0X10⁶ | 2.7X10^-5 | | Zr-93 (b) | | 1.0X10³ | 2.7X10^-8 | 1.0X10⁷ | 2.7X10^-4 | | Zr-95 | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁶ | 2.7X10^-5 | | Zr-97 (b) | | 1.0X10¹ | 2.7X10^-10 | 1.0X10⁵ | 2.7X10^-6 | | ^a(Reserved) ^bParent nuclides and their progeny included in secular equilibrium are listed in the following: | | | | | | | Sr-90 | Y-90 | | | | | | Zr-93 | Nb-93m | | | | | | Zr-97 | Nb-97 | | | | | | Ru-106 | Rh-106 | | | | | | Cs-137 | Ba-137m | | | | | | Ce-144 | Pr-144 | | | | | | Ba-140 | La-140 | | | | | | Bi-212 | Tl-208 (0.36), Po-212 (0.64) | | | | | | Pb-210 | Bi-210, Po-210 | | | | | | Pb-212 | Bi-212, Tl-208 (0.36), Po-212 (0.64) | | | | | | Rn-222 | Po-218, Pb-214, Bi-214, Po-214 | | | | | | Ra-223 | Rn-219, Po-215, Pb-211, Bi-211, Tl-207 | | | | | | Ra-224 | Rn-220, Po-216, Pb-212, Bi-212, Tl-208(0.36), Po-212 (0.64) | | | | | | Ra-226 | Rn-222, Po-218, Pb-214, Bi-214, Po-214, Pb-210, Bi-210, Po-210 | | | | | | Ra-228 | Ac-228 | | | | | | Th-228 | Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64) | | | | | | Th-229 | Ra-225, Ac-225, Fr-221, At-217, Bi-213, Po-213, Pb-209 | | | | | | Th-nat | Ra-228, Ac-228, Th-228, Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64) | | | | | | Th-234 | Pa-234m | | | | | | U-230 | Th-226, Ra-222, Rn-218, Po-214 | | | | | | U-232 | Th-228, Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64) | | | | | | U-235 | Th-231 | | | | | | U-238 | Th-234, Pa-234m | | | | | | U-nat | Th-234, Pa-234m, U-234, Th-230, Ra-226, Rn-222, Po-218, Pb-214, Bi-214, Po-214, Pb-210, Bi-210, Po-210 | | | | | | Np-237 | Pa-233 | | | | | | Am-242m | Am-242 | | | | | | Am-243 | Np-239 | | | | | | ^c(Reserved) ^dThese values apply only to compounds of uranium that take the chemical form of UF₆, UO₂F₂ and UO₂(NO₃)₂ in both normal and accident conditions of transport. ^eThese values apply only to compounds of uranium that take the chemical form of UO₃, UF₄, UCl₄ and hexavalent compounds in both normal and accident conditions of transport. ^fThese values apply to all compounds of uranium other than those specified in notes (d) and (e) of this table. ^gThese values apply to unirradiated uranium only. | | | | | |

H. Table 3. General Values for A₁ and A₂.

| Contents | A₁ | A₂ | Activity concentration for exempt material (Bq/g) | Activity concentration for exempt material (Ci/g) | Activity limits for exempt consignments (Bq) | Activity limits for exempt consignments (Ci) | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | (TBq) | (Ci) | (TBq) | (Ci) | | | | | | | Only beta or gamma emitting radionuclides are known to be present | 1 x 10^-1 | 2.7 x 10⁰ | 2 x 10^-2 | 5.4 x 10^-1 | 1 x 10¹ | 2.7 x10^-10 | 1 x 10⁴ | 2.7 x10^-7 | | Alpha emitting radionuclides, but no neutron emitters, are known to be present (a) | 2 x 10^-1 | 5.4 x 10⁰ | 9 x 10^-5 | 2.4 x 10^-3 | 1 x 10^-1 | 2.7 x10^-12 | 1 x 10³ | 2.7 x10^-8 | | Neutron emitting nuclides are known to be present or no relevant data are available | 1 x 10^-3 | 2.7 x 10^-2 | 9 x 10^-5 | 2.4 x 10^-3 | 1 x 10^-1 | 2.7 x 10^-12 | 1 x 10³ | 2.7 x 10^-8 | | ^aIf beta or gamma emitting nuclides are known to be present, the A₁ value of 0.1 TBq (2.7 Ci) should be used. | | | | | | | | |

I. Table 4. Activity-Mass Relationships for Uranium.

| Uranium Enrichment¹ wt % U-235 present | Specific Activity | | | --- | --- | --- | | TBq/g | Ci/g | | | 0.45 | 1.8 x 10^-8 | 5.0 x 10^-7 | | 0.72 | 2.6 x 10^-8 | 7.1 x 10^-7 | | 1 | 2.8 x 10^-8 | 7.6 x 10^-7 | | 1.5 | 3.7 x 10^-8 | 1.0 x 10^-6 | | 5 | 1.0 x 10^-7 | 2.7 x 10^-6 | | 10 | 1.8 x 10^-7 | 4.8 x 10^-6 | | 20 | 3.7 x 10^-7 | 1.0 x 10^-5 | | 35 | 7.4 x 10^-7 | 2.0 x 10^-5 | | 50 | 9.3 x 10^-7 | 2.5 x 10^-5 | | 90 | 2.2 x 10^-6 | 5.8 x 10^-5 | | 93 | 2.6 x 10^-6 | 7.0 x 10^-5 | | 95 | 3.4 x 10^-6 | 9.1 x 10^-5 | | ¹The figures for uranium include representative values for the activity of the uranium-234 that is concentrated during the enrichment process. | | |

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008; amended, Virginia Register Volume 32, Issue 24, eff. August 25, 2016; Volume 34, Issue 2, eff. October 18, 2017; Volume 39, Issue 24, eff. August 16, 2023.

12VAC5-481-3780 Nationally tracked source thresholds

The terabecquerel (TBq) values are the regulatory standard. The curie (Ci) values specified are obtained by converting from the TBq value. The curie values are provided for practical usefulness only and are rounded after conversion.

| Radioactive material | Category 1 (TBq) | Category 1 (Ci) | Category 2 (TBq) | Category 2 (Ci) | | --- | --- | --- | --- | --- | | Actinium-227 | 20 | 540 | 0.2 | 5.4 | | Americium-241 | 60 | 1,600 | 0.6 | 16 | | Americium-241/Be | 60 | 1,600 | 0.6 | 16 | | Californium-252 | 20 | 540 | 0.2 | 5.4 | | Cobalt-60 | 30 | 810 | 0.3 | 8.1 | | Curium-244 | 50 | 1,400 | 0.5 | 14 | | Cesium-137 | 100 | 2,700 | 1 | 27 | | Gadolinium-153 | 1,000 | 27,000 | 10 | 270 | | Iridium-192 | 80 | 2,200 | 0.8 | 22 | | Plutonium-238 | 60 | 1,600 | 0.6 | 16 | | Plutonium-239/Be | 60 | 1,600 | 0.6 | 16 | | Polonium-210 | 60 | 1,600 | 0.6 | 16 | | Promethium-147 | 40,000 | 1,100,000 | 400 | 11,000 | | Radium-226 | 40 | 1,100 | 0.4 | 11 | | Selenium-75 | 200 | 5,400 | 2 | 54 | | Strontium-90 | 1,000 | 27,000 | 10 | 270 | | Thorium-228 | 20 | 540 | 0.2 | 5.4 | | Thorium-229 | 20 | 540 | 0.2 | 5.4 | | Thulium-170 | 20,000 | 540,000 | 200 | 5,400 | | Ytterbium-169 | 300 | 8,100 | 3 | 81 |

History

• Statutory Authority: § 32.1-229 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Chapter 501 Rules and Regulations Governing the Construction and Maintenance of Migrant Labor Camps

Part I Definitions and General Provisions

12VAC5-501-10 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Approved water supply" means a waterworks that has a valid waterworks operation permit from the commissioner or a water supply that is evaluated, tested and, if found in compliance with the applicable standards, accepted and approved by the director or the director's designee.

"Board" means the State Board of Health.

"Camp operator" means a person who has charge, care, or control of a migrant labor camp.

"Commissioner" means the State Health Commissioner or his designee who has been delegated powers in accordance with subdivision 2 of 12VAC5-501-30.

"Department" means the Virginia Health Department.

"Director" means the director of a city, county or district health department or his designated representative who is assigned responsibility for implementation of these regulations at the local level.

"Migrant labor camp" or "camp" means one or more structures, buildings, tents, barracks, trailers, vehicles, converted buildings, and unconventional enclosures of living space, reasonably contiguous, together with the land appertaining thereto, established, operated or used as living quarters for one or more persons, one or more of whom is a migrant worker engaged in agricultural or fishing activities, including related food processing. "Migrant labor camp" does not include (i) a summer camp, campground or hotel as defined in § 35.1-1 of the Code of Virginia, (ii) housing that, in the ordinary course of business, is regularly offered to the general public on a commercial basis and is provided to any migrant worker on the same or comparable terms and conditions as provided to the general public, or (iii) small businesses that are exempt under federal law as provided in the Fair Labor Standards Act (29 USC § 201 et seq.) and the Migrant and Seasonal Worker Protection Act (29 USC § 1801 et seq.).

"Migrant worker" means any individual from within or outside the Commonwealth who passes seasonally from one place to another for the purpose of employment (agricultural or fishing activities, including related food processing), who is not a year-round employee, and who occupies living quarters other than his permanent home during the period of such work.

"Owner" means a person who owns, leases or proposes to own or lease a migrant labor camp.

"Person" means an association, a corporation, individual, partnership, other legal entity, government, or governmental subdivision or agency.

"Variance" means a conditional waiver of a specific regulation granted by the commissioner or his designee pursuant to 12VAC5-501-120 to a specific camp operator relating to a specific situation or facility and may be for a specific period of time.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-501-20 Purpose of regulations

This chapter has been promulgated by the State Board of Health to ensure that safe and healthy living conditions are provided for migrant workers and their families while they are employed and living in the Commonwealth of Virginia. This chapter establishes standards and procedures that the State Health Commissioner will follow in determining whether a permit to operate a migrant labor camp should be issued, denied, revoked, or suspended. In a similar way the chapter also delineates the procedures and requirements with which a camp must comply in order for the camp operator to obtain and retain a permit.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-501-30 Administration of regulations

These regulations are administered by the following:

1. The State Board of Health, hereinafter referred to as the board, has responsibility to promulgate, amend and repeal regulations necessary to protect the public health.

2. The State Health Commissioner, hereinafter referred to as the commissioner, is the chief executive officer of the State Department of Health. The commissioner has the authority to act for the board when it is not in session (see § 32.1-20 of the Code of Virginia). The commissioner may delegate his powers under these regulations in writing to any subordinate.

3. The State Department of Health hereinafter referred to as "department" is designated as the primary agent of the commissioner for the purpose of administering these regulations.

4. The district or local health department is responsible for implementing and enforcing the regulatory activities required by these regulations.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-501-40 Right of entry to inspect, etc.; warrants

Upon presentation of appropriate credentials and upon consent of the owner, camp operator or custodian, the commissioner or his designee shall have the right to enter at any reasonable time onto any property to inspect, investigate, evaluate, conduct tests or take samples for testing as he reasonably deems necessary in order to determine compliance with the provisions of this chapter, any order of the board or commissioner, or any conditions in a permit, license or certificate issued by the board or commissioner. If the commissioner or his designee is denied entry, he may apply to an appropriate circuit court for an inspection warrant authorizing such investigation, evaluation, inspection, testing, or taking of samples for testing as provided in Chapter 24 (§ 19.2-393 et seq.) of Title 19.2 of the Code of Virginia.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

Part II Procedural Regulations

12VAC5-501-50 Continuing validity of existing permits

Operational permits in effect prior to January 1, 2006, unless otherwise revoked, shall remain valid until the expiration date of the permit.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-501-60 Application of the Administrative Process Act

The provisions of Article 3 (§ 2.2-4018 et seq.) of the Virginia Administrative Process Act shall govern the procedures for rendering all case decisions.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-501-70 Emergency orders

The commissioner may, pursuant to §§ 32.1-13 and 32.1-20 of the Code of Virginia, issue emergency orders as is necessary to preserve the public health, safety, welfare and environment. Emergency orders arising out of matters governed by these regulations shall state the reasons and factual basis upon which the emergency order is issued. The emergency order shall state the time period for which it is effective.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-501-80 Enforcement of regulations

A. Notice. Whenever the commissioner or any district or local health department official has reason to believe that a violation of Title 32.1 or Title 35.1 of the Code of Virginia or of any provision of this chapter has occurred or is occurring, he shall so notify the alleged violator. Such notice shall be (i) in writing, with a request to the owner or camp operator to respond by providing any pertinent information on this issue they may wish; (ii) cite the statute, regulation or regulations that are allegedly being violated; and (iii) state the facts that form the basis for believing that the violation has occurred or is occurring. Such notification may be accompanied by a request that certain corrective action be taken.

B. Orders. Pursuant to the authority granted in §§ 32.1-26 and 35.1-6 of the Code of Virginia, the commissioner may issue orders to require any owner or camp operator, or other person, to comply with the provisions of these regulations. The order may require the following:

1. The immediate cessation and correction of the violation;

2. Appropriate remedial action to ensure that the violation does not continue or recur;

3. The submission of a plan to prevent future violations;

4. The submission of an application for a variance; and

5. Any other corrective action deemed necessary to comply with the regulations.

C. Hearing before the issuance of an order. Before the issuance of an order, pursuant to subsection B of this section, the commissioner must comply with the requirements of § 32.1-26 of the Code of Virginia.

D. Order—when effective. All orders issued pursuant to subsection B of this section shall become effective not less than 15 days after mailing a copy thereof by certified mail to the last known address of the owner, camp operator or person violating these regulations. Violation of an order is a Class 1 misdemeanor. See § 32.1-27 of the Code of Virginia.

E. Compliance. The commissioner may act as the agent of the board to enforce all effective orders and these regulations. Should any owner or camp operator fail to comply with any effective order or these regulations, the commissioner may:

1. Institute a proceeding to revoke the camp operator's permit in accordance with 12VAC5-501-230;

2. Request the attorney for the Commonwealth to bring a criminal action;

3. Request the Attorney General to bring an action for civil penalty, injunction, or other appropriate remedy; or

4. Do any combination of the above.

F. Not exclusive means of enforcement. Nothing contained in 12VAC5-501-70 or this section shall be interpreted to require the commissioner to issue an order prior to seeking enforcement of any regulation or statute through an injunction, mandamus or criminal prosecution.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-501-90 Penalties, injunctions, civil penalties, and charges for violations

A. Any person willfully violating or refusing, failing, or neglecting to comply with any regulation or order of the board or commissioner or any provision of this chapter shall be guilty of a Class 1 misdemeanor unless a different penalty is specified.

B. Any person willfully violating or failing, neglecting or refusing to obey any lawful regulation or order of the board or commissioner or any provision of this chapter may be compelled in a proceeding instituted in an appropriate court by the board or commissioner to obey such regulations, order, or provision of this chapter and to comply therewith by injunction, mandamus, or other appropriate remedy.

C. Without limiting the remedies that may be obtained in subsection B of this section, any person violating or failing, neglecting or refusing to obey any injunction, mandamus or other remedy obtained pursuant to subsection B of this section shall be subject, in the discretion of the court, to a civil penalty not to exceed $25,000 for each violation. Each day of violation shall constitute a separate offense.

D. With the consent of any person who has violated or failed, neglected, or refused to obey any regulation or order of the board or commissioner or any provision of this chapter, the board may provide, in an order issued by the board against such person, for the payment of civil charges for past violations in specific sums not to exceed the limit specified in subsection C of this section. Such civil charges shall be instead of any appropriate civil penalty that could be imposed under subsection C of this section.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-501-100 OSHA enforcement

Nothing contained herein shall be construed to bar the enforcement of occupational safety and health standards adopted by the Safety and Health Codes Board in the manner prescribed in Chapter 3 (§ 40.1-22 et seq.) of Title 40.1 of the Code of Virginia and regulations promulgated thereunder.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-501-110 Suspension of regulations during disasters

If, in the case of a manmade or natural disaster, the commissioner finds that certain regulations cannot be complied with and that the public health is better served by not fully complying with these regulations, he may authorize the suspension of the application of the regulations for specifically affected localities and institute a provisional regulatory plan until the disaster is abated.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-501-120 Variances

A. In accordance with § 40.1-6 (9) of the Code of Virginia, a variance to those occupational safety and health regulations set forth at 29 CFR Part 1910 may be granted by the Commissioner of Labor and Industry. Applications for such variances shall be directed to him.

B. The State Health Commissioner or his designee may grant a variance to these regulations by following the appropriate procedures set forth in this subsection.

1. Requirements for a variance to these regulations. The commissioner may grant a variance if he finds that the hardship imposed, which may be economic, outweighs the benefits that may be received by the public and that granting such a variance does not subject the public to unreasonable health risks or environmental pollution.

2. Application for a variance to these regulations. Any camp operator who seeks a variance shall apply in writing within the time period specified in this subsection. The request should be sent to the local health department. Any request for a variance must be made in writing and received by the department prior to the denial of the migrant labor camp permit, or within 30 days after such denial. In the event a person applies for a variance within the 30-day period after the permit has been denied, the date for appealing the denial of the permit, pursuant to 12VAC5-501-160, shall commence from the date on which the department acts on the request for a variance. The application for a variance shall include:

a. A citation to the regulation from which a variance is requested;

b. The nature and duration of the variance requested;

c. Any relevant analytical results including results of relevant tests conducted pursuant to the requirements of these regulations;

d. Statements or evidence that establish that the public health, welfare and environment would not be adversely affected if the variance were granted;

e. Suggested conditions that might be imposed on the granting of a variance that would limit the detrimental impact on the public health and welfare;

f. Other information believed pertinent by the applicant; and

g. Such other information as the district or local health department or commissioner may require.

C. Evaluation of an application for a variance to these regulations.

1. The commissioner shall act on any request for a variance to these regulations submitted pursuant to this subsection within 60 days of receipt of the request.

2. In evaluating a variance application, the commissioner shall consider such factors as the following:

a. The effect that such a variance would have on the operation of the migrant labor camp;

b. The cost and other economic considerations imposed by this requirement;

c. The effect that such a variance would have on protection of the public health, safety, welfare and the environment; and

d. Such other factors as the commissioner may deem appropriate.

D. Disposition of a request for a variance to these regulations.

1. If the commissioner proposes to deny the variance, he shall provide the camp operator an opportunity to an informal hearing as provided in § 2.2-4019 of the Code of Virginia. Following this opportunity for an informal hearing, the commissioner may reject any application for a variance by sending a rejection notice to the applicant. The rejection notice shall be in writing and shall state the reasons for the rejection. A rejection notice constitutes a case decision.

2. If the commissioner proposes to grant a variance request submitted pursuant to this chapter, the applicant shall be notified in writing of this decision. Such notice shall identify the variance and the migrant labor camp involved, and shall specify the period of time for which the variance will be effective. Such notice shall provide that the variance will be terminated when the migrant labor camp comes into compliance with the applicable regulation and may be terminated upon a finding by the commissioner that the migrant labor camp has failed to comply with any requirements or schedules issued in conjunction with the variance. The effective date of the variance shall be as noted in the variance letter.

3. All variances to these regulations granted to any migrant labor camp are not transferable unless otherwise stated. Each variance shall be attached to the permit to which it is granted. Each variance is revoked when the permit to which it is attached is revoked.

4. No camp operator may challenge the terms or conditions of a variance after 30 calendar days have elapsed from the receipt of the variance.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-501-130 Case decisions

The commissioner or the commissioner's designee may make case decisions based on informal hearings. An informal hearing is conducted by the department and held in conformance with § 2.2-4019 of the Code of Virginia. The district or local health department may record the hearing or create a written summary or record of the proceedings.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 42, Issue 5, eff. November 19, 2025.

12VAC5-501-140 Request for hearing

A request for a hearing shall be made by sending the request in writing to the district or local health department in the locality where the migrant labor camp is located. Requests for hearings shall cite the reasons for the hearing request and shall cite the sections of these regulations involved and must be received within 30 calendar days of the decision by the department that led to the hearing request.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-501-150 Hearing

Any owner, camp operator or named party whose rights, duties, or privileges have been, or may be affected by any case decision of the board or its subordinates in the administration of these regulations shall have a right to a hearing.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-501-160 Appeals

A. Any appeal from a denial of a permit to operate a migrant labor camp must be made in writing and received by the local or state health department within 30 days of the date the denial letter was received.

B. Any request for hearing on the denial of an application for a variance pursuant to 12VAC5-501-120 D 1 must be made in writing and received within 30 days of receipt of the denial notice.

C. Pursuant to the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia), an aggrieved owner or camp operator may appeal a final decision of the commissioner to the appropriate circuit court.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-501-170 Notice of intention to construct or remodel camp and submission of plans

Any person planning to construct, substantially remodel, or enlarge for occupancy or use a migrant labor camp or any portion of the facility thereof, or to convert a property for use or occupancy as a camp shall give notice in writing to the local health director of his intent to do so at least 30 days before the date of beginning such construction, remodeling, enlargement, or conversion. The notice shall include the name of the city or county in which the property is located; the location of the property within that area; plans of the proposed construction, remodeling, enlargement or conversion; and the name, mailing address and telephone number of the person giving the notice. Upon receipt of such notice, the local health director shall forward to such person a copy of Article 6 (§ 32.1-203 et seq.) of Chapter 6 of Title 32.1 of the Code of Virginia relating to migrant labor camps and a copy of this chapter.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-501-180 Permits

A. No person shall own, establish, conduct, maintain, manage, or operate any migrant labor camp in this Commonwealth unless the migrant labor camp is permitted as provided in this section. All permits shall be in the name of the camp operator. Permits shall not be issued to newly constructed or extensively remodeled migrant labor camps until a certificate of occupancy has been issued by the building official. Only a person who complies with the requirements of these regulations shall be entitled to receive or retain such a permit.

B. Nontransference of migrant labor camp permits. Permits issued shall not be transferable from one person to another or from one location to another. A new camp operator shall be required to make a written application for a permit. The application forms are available from local health departments.

C. Requirements for posting permits. The permit shall be posted in a location in the camp readily visible and accessible to the migrant workers.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-501-190 Application for permit

A. Application for a permit to operate a migrant labor camp shall be made on a form prescribed by the board to the local health director of the county or city in which the migrant labor camp is located at least 30 days before such camp is to be opened. A separate application shall be submitted for each camp every year.

B. The local health director shall issue a permit after an inspection if the camp is found to be in compliance with this chapter.

C. If the camp is not found to be in compliance, the local health director may deny, revoke or suspend the permit or recommend denial of a variance.

D. Any expansion or modification of a permitted migrant labor camp shall require the obtaining of a new permit.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-501-200 Issuance of permit

Prior to the issuance of a permit, the director or his designee shall inspect the migrant labor camp to determine compliance with the requirements of these regulations. The department shall issue a permit to the applicant if its inspection reveals that the proposed migrant labor camp complies with all requirements of these regulations. The permit shall expire annually on December 31. Also, changes in the camp operator void the permit and the new camp operator must apply for a new permit.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-501-210 Denial of a permit

Whenever the department denies a permit to operate a migrant labor camp, it shall, within 10 days of the inspection, send the applicant a written explanation of the reasons why the permit was denied.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-501-220 Suspension of a permit

The director may suspend a permit to operate a migrant labor camp without an informal hearing if the director finds the continued operation constitutes a substantial and imminent threat to the public health. Upon receipt of such notice that a permit is suspended, the permit holder shall cease operation immediately and begin corrective action.

Whenever a permit is suspended, the holder of the permit or the camp operator shall be notified in writing by certified mail or by hand delivery. Upon service of notice that the permit is immediately suspended, the former permit holder shall be given an opportunity to request an informal hearing. If a permit holder wants to request an informal hearing, he must submit a request in writing to the director within 10 working days after he receives notice of the suspension. The written request shall be filed with the local health director by the former holder of the permit. If written request for an informal hearing is not filed within 10 working days, the suspension is sustained. Each holder of a suspended permit shall be afforded an opportunity for an informal hearing within three working days of receipt of a request for an informal hearing. The director may end the suspension at any time if the reasons for suspension no longer exist.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-501-230 Revocation

Prior to revocation, the director shall notify in writing the holder of the permit, or the camp operator, of the specific reason or reasons for which the permit is to be revoked. The permit shall be revoked at the end of the 30 days following service of such notice unless a written request for an informal conference is filed with the director within 10 days after the permit holder received the notice of revocation. If no request for an informal conference is filed within the 10-day period, the revocation of the permit shall be final.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-501-240 Application after revocation

Any person whose permit has been revoked may apply for a new permit, after complying with these regulations, by following the procedures of these regulations.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-501-250 Compliance with regulations

The camp operator shall be responsible for ensuring that the migrant labor camp is in compliance with these and any applicable occupational safety and health regulations throughout the period for which the permit is valid.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-501-260 Inspections to be conducted

The local health director or his designated representative shall make inspections of camps occupied by migrants to determine compliance with this chapter. If a camp is found not to be in compliance, the local health department may move to suspend or revoke the permit. Migrant labor camps shall be inspected as often as necessary during their occupancy to ensure compliance with the regulations.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-501-270 Inspection report

The director or his designated representative who conducts an inspection of a camp shall provide the camp operator with a copy of a completed inspection report after an inspection has been conducted. The report shall indicate that the camp is either in compliance or shall specify which specific standards the director or his designated representative has reason to believe have been or are being violated. The inspection report shall further specify needed corrective action or abatement procedures and a date by which this action is requested to be completed or the problem abated.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-501-280 Correction

The completed inspection report shall specify a reasonable period of time for the correction of the suspected violations found. Where a period of time for the correction is specified, the correction shall be accomplished within the period specified and in accordance with the following provisions:

1. Should a substantial and imminent health hazard be declared by the director, including, but not limited to, substantial fire damage, sewage backing into the living or food preparation and service areas, lack of refrigeration or lack of water, the operator shall immediately cease operations. Operations shall not be resumed until authorized by the director. Authorization shall not be granted until such violations are corrected.

2. All suspected violations identified by the department are to be corrected within a reasonable period of time or as soon as possible, but in any event, within the period of time specified. A follow-up inspection shall be conducted by the director or his designee to confirm the corrections.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

Part III Standards

12VAC5-501-290 Primary source of standards

The occupational safety and health (OSHA) standards governing temporary labor camps (29 CFR 1910.142) promulgated by the Virginia Safety and Health Codes Board shall apply to migrant labor camps, subject to the exceptions and regulations in 12VAC5-501-300.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-501-300 Exception to occupational safety and health standards

A. Migrant housing facilities constructed or under construction prior to April 3, 1980, or where a contract for construction was signed prior to March 4, 1980, shall be governed by either: (i) 20 CFR 654.401 et seq.; (ii) 12VAC5-501-250; or (iii) variances granted thereto. The choice of governing standards shall be left to the discretion of the individual camp operator. The camp operator shall specify in his application the standard by which he elects to be governed.

B. Migrant housing facilities constructed or under construction on or after April 3, 1980, or where a contract for construction was signed on or after March 4, 1980, shall be governed by the requirements of 12VAC5-501-290 or variances granted thereto.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-501-310 Trash and garbage collections

The camp operator shall provide either a bulk container into which family trash containers may be emptied by the migrant families or provide for a regular trash and garbage collection service. Refuse from the individual garbage cans and the bulk containers shall be disposed of by the camp operator in a manner authorized by the Solid Waste Management Regulations (9VAC20-80) of the Virginia Waste Management Board.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-501-320 Requirements for water supplies

All migrant labor camps shall have an approved water supply.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-501-330 Requirements of sewage disposal

All migrant labor camps shall comply with the board's regulations governing the disposal of sewage (12VAC5-610), promulgated pursuant to §§ 32.1-163 through 32.1-166 of the Code of Virginia. A copy of these regulations may be obtained from the local health department.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-501-340 Storage of hazardous materials

Agricultural pesticides or toxic chemicals shall be stored in secure, partitioned areas that are separate from food and living quarters. Pesticide storage areas shall be at least 100 feet from existing wells or surface water unless barriers or environmental safeguards are present that will prevent contamination of groundwater or surface water from a discharge. The entry to the pesticide storage area shall be clearly marked indicating that pesticides or hazardous materials are stored within. When not in use, the pesticide storage area shall be locked to minimize the unauthorized entry into the storage area. Water and personal protective equipment, as required on the labels of the stored pesticides, shall be available for employee protection in the event of a discharge or other emergency.

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-501-350 Conformity with Uniform Statewide Building Code

All newly constructed migrant labor camps shall comply with the Virginia Uniform Statewide Building Code (13VAC5-63).

History

• Statutory Authority: § 32.1-211 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

Chapter 507 Nursing Scholarships and Loan Repayment Program Requiring Service in a Long-Term Care Facility

Part I General Information

12VAC5-507-10 Definitions

The following words and terms when used in this chapter shall have the following meanings:

"Approved nurse education program" means an approved educational program pursuant to Chapter 30 (§ 54.1-3000 et seq.) of Title 54.1 of the Code of Virginia.

"Board" or "Board of Health" means the State Board of Health.

"Certified nurse aide" or "CNA" means a person who is certified by the Board of Nursing under the provisions of Chapter 30 (§ 54.1-3000 et seq.) of Title 54.1 of the Code of Virginia.

"Commercial loans" means loans made by banks, credit unions, savings and loan associations, insurance companies, schools, and either financial or credit institutions that are subject to examination and supervision in their capacity as lenders by an agency of the United States or of the state in which the lender has its principal place of business.

"Commissioner" means the State Health Commissioner.

"Department" means Virginia Department of Health.

"Full-time" means at least 32 hours per week for 45 weeks per year.

"Licensed practical nurse" or "LPN" means a person who is licensed or holds a multistate licensure privilege under the provisions of Chapter 30 (§ 54.1-3000 et seq.) of Title 54.1 of the Code of Virginia to practice practical nursing as defined in § 54.1-3000 of the Code of Virginia.

"Long-term care facility" means a certified nursing facility or nursing home as defined in § 32.1-123 of the Code of Virginia.

"Participant" means an eligible registered nurse, a licensed practical nurse, or a certified nurse aide student or graduate who enters into a contract with the commissioner and participates in the scholarship or loan repayment program.

"Penalty" means twice the amount of all monetary payments to the scholarship or loan repayment participant, less any service obligation completed.

"Reasonable educational expenses" means the costs of education, exclusive of tuition, that are considered to be required by the school's degree program or an eligible program of study, such as fees for room, board, transportation and commuting costs, books, supplies, educational equipment and materials, and travel, that were a part of the estimated student budget of the school in which the participant is or was enrolled.

"Registered nurse" or "RN" means a person who is licensed or holds a multistate licensure privilege under the provisions of Chapter 30 (§ 54.1-3000 et seq.) of Title 54.1 of the Code of Virginia to practice professional nursing as defined in § 54.1-3000 of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.6:01 and 54.1-3011.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 21, eff. July 13, 2016.

12VAC5-507-15 Nursing Scholarship Advisory Committee

All scholarship and loan repayment awards shall be made by an Advisory Committee appointed pursuant to § 23-35.9 of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.6:01 and 54.1-3011.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 21, eff. July 13, 2016.

Part II Administration of Nursing Scholarships

12VAC5-507-20 Eligibility for scholarships

In order to be considered for a scholarship, an applicant shall:

1. Be a United States citizen, a United States national, or a qualified alien pursuant to 8 USC § 1621;

2. Be a bona fide resident of Virginia by being domiciled in the Commonwealth for at least one year as defined in § 23-74 of the Code of Virginia;

3. Be accepted for enrollment or enrolled in an approved nursing education program in the Commonwealth of Virginia preparing him for examination for licensure as a practical nurse or registered nurse or accepted for enrollment or enrolled in an approved nurse aide education program in the Commonwealth of Virginia preparing him for certification;

4. If already enrolled in an approved nursing education program in the Commonwealth of Virginia or an approved nurse aide education program in the Commonwealth of Virginia, have a cumulative grade point average of 2.5 in core nursing classes;

5. Submit a completed application form and appropriate grade transcript prior to the established deadline dates;

6. Demonstrate financial need, which is verified by the school's financial aid officer or authorized person as part of the application process; and

7. Not have an active military obligation.

An applicant who fails to meet all of these requirements shall be ineligible for a scholarship.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.6:01 and 54.1-3011.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 21, eff. July 13, 2016.

12VAC5-507-30 Conditions of scholarships

A. Prior to becoming a participant in the nursing scholarship program, the applicant shall enter into a contract with the commissioner agreeing to the terms and conditions upon which the scholarship is granted.

B. For each $2,000 of scholarship money received, the participant agrees to engage in the equivalent of one year of full-time nursing practice in a long-term care facility in the Commonwealth. The participant shall notify the department, within 180 days of being awarded a nursing diploma or degree, of the type of nursing practice to be performed and give the name and address of the employer for approval. Voluntary military service, even if stationed in Virginia, cannot be used to repay the service obligation required when a scholarship is awarded.

The participant may request approval of a change of practice site. Such requests shall be made in writing. The department in its discretion may approve such a request.

C. If a participant fails to complete his studies, the full amount of the scholarship or scholarships received, plus applicable interest charge, must be repaid.

D. If upon graduation a participant leaves the Commonwealth or fails to engage or ceases to engage in nursing practice in a long-term care facility in Virginia before all employment conditions of the scholarship award are fulfilled, the participant shall repay the award amount reduced by the proportion of obligated years served plus applicable interest and penalty.

E. If the participant is in default due to death or permanent disability so as not to be able to engage in nursing practice in a long-term care facility, the participant or his personal representative may be relieved of his obligation under the contract to engage in nursing practice upon repayment of the total amount of scholarship or loan repayment funds received plus applicable interest. For participants completing part of the nursing obligation prior to becoming permanently disabled or in the event of death, the total amount of scholarship or loan repayment funds owed shall be reduced by the proportion of obligated years served. The obligation to make restitution may be waived by the board upon application of the participant or the participant's personal representative to the board.

F. Individual cases may be considered by the board for a variance of payment or service, pursuant to § 32.1-12 of the Code of Virginia, if the board finds compliance with the applicable service requirements or default repayment would pose an undue hardship on the participant.

G. All default payments shall be made payable to the Commonwealth of Virginia.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.6:01 and 54.1-3011.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 21, eff. July 13, 2016.

12VAC5-507-40 Number of applications per student

Scholarships are awarded for single academic years. However, the same student may, after demonstrating satisfactory progress in his studies, which is demonstrated by a cumulative grade point average of 2.5 in core nursing classes, apply for and receive scholarship awards for a succeeding academic year or years. No student shall receive scholarships for more than a total of four years.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.6:01 and 54.1-3011.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 21, eff. July 13, 2016.

12VAC5-507-50 Amounts of scholarships

The number of scholarships awarded shall be dependent upon the amount of money appropriated by the General Assembly, the amount of the funds available within the Nursing Scholarship and Loan Repayment Fund administered by the Board of Nursing pursuant to § 54.1-3011.2 of the Code of Virginia, and the number of qualified applicants. Each participant shall receive an award of $2,000 per year.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.6:01 and 54.1-3011.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 21, eff. July 13, 2016.

12VAC5-507-60 How to apply for a scholarship

Eligible applicants shall submit a complete application on a form made available by the department on the department's website. A complete application shall include documentation of all eligibility requirements. The deadline for submission of the application shall be announced by the department on the department's website.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.6:01 and 54.1-3011.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 21, eff. July 13, 2016.

12VAC5-507-70 Reporting requirements of scholarship participants

Reporting requirements of the scholarship participant are as follows:

1. Each participant shall provide information as required by the department to verify compliance with the practice requirements of the nursing scholarship program (e.g., verification of employment in a long-term care facility by submitting a Verification of Employment form once every six months).

2. Each participant shall promptly notify the department in writing within 30 days if any of the following events occur:

a. Participant changes name;

b. Participant changes address;

c. Participant changes practice site (participant is required to request in writing and obtain prior approval of changes in practice site);

d. Participant no longer intends to or is unable to fulfill service obligation as a nurse in the Commonwealth in a long-term care facility;

e. Participant ceases to practice as a registered nurse, licensed practical nurse, or certified nurse aide; or

f. Participant ceases to or no longer intends to complete his nursing school program.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.6:01 and 54.1-3011.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 21, eff. July 13, 2016.

12VAC5-507-80 [Reserved]

Historical Notes

Reserved Virginia Register Volume 32, Issue 21, eff. July 13, 2016.

Part III Administration of the Nursing Loan Repayment Program

12VAC5-507-90 Eligibility for the nursing loan repayment program

An eligible applicant for the nursing loan repayment program shall:

1. Be a United States citizen, a United States national, or a qualified alien pursuant to 8 USC § 1621;

2. Be domiciled in Virginia for at least one year as defined in § 23-7.4 of the Code of Virginia;

3. Be a registered nurse, licensed practical nurse, or certified nurse aide;

4. Have graduated from an approved nurse education program pursuant to Chapter 30 (§ 54.1-3000 et seq.) of Title 54.1 of the Code of Virginia;

5. Have a valid unrestricted Virginia license to practice nursing as an RN, LPN, or CNA, a copy of which shall be furnished to the nursing loan repayment program;

6. Have submitted a completed application to participate in the nursing loan repayment program;

7. Have no other contractual service obligation unless completely satisfied before the nursing loan repayment program contract has been signed;

8. Not have an active military obligation;

9. Be employed or have a contract for employment in a long-term care facility within a month of the application date;

10. Not have a history of failing to comply with, or inability to comply with, service or payment obligations;

11. Not have a history of noncompliance within any other state or federal scholarship or loan repayment program; and

12. Have an educational loan balance that can be verified.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.6:01 and 54.1-3011.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 21, eff. July 13, 2016.

12VAC5-507-100 Application requirement

The applicant shall submit a completed application, including documentation of eligibility requirements, to the nursing loan repayment program, and the application must be received in the department by the deadline date published on the department's website. The application form shall be available on the department's website.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.6:01 and 54.1-3011.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 21, eff. July 13, 2016.

12VAC5-507-110 Selection criteria

Applicants shall be competitively reviewed and selected by the Nursing Scholarship Advisory Committee for recommendation to the commissioner for participation in the nursing loan repayment program based upon the following criteria:

1. Qualifications. Decisions for determining loan repayment participants shall be based on an evaluation of an individual's qualifications and competency to practice. These qualifications may include attainment and maintenance of a Virginia nursing license or certification, additional certification in a specialty, professional achievements, and other indices of competency received from supervisors and program directors.

2. Virginia graduates. Preferential consideration shall be given to individuals who are graduates of Virginia nursing schools (verification will be obtained by the nursing loan repayment program).

3. Availability for service. Preferential consideration shall be given to individuals who are immediately eligible and available for service in a long-term care facility.

4. Length of proposed commitment. Preferential consideration shall be given to individuals who commit to longer periods of service in a long-term care facility.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.6:01 and 54.1-3011.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 21, eff. July 13, 2016.

12VAC5-507-120 Loan repayment amount

The applicant shall agree to provide full-time nursing services in a long-term care facility in the Commonwealth a minimum of one year for a loan repayment amount up to $2,000 with an option for renewal in the second, third, and fourth year upon submitting a new application, with a potential maximum award amount of $8,000. Renewals shall only be granted if an applicant can show a reduction in his educational loan balances. The loan repayment amount shall depend upon availability of funds and the applicant's indebtedness, but no amount shall exceed the total indebtedness.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.6:01 and 54.1-3011.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 21, eff. July 13, 2016.

12VAC5-507-130 Loans qualifying for repayment

A. Based on the availability of funds, the loan repayment program shall pay toward the outstanding principal and interest of verifiable federal, state, or local government loans and commercial loans obtained by the participant for the following:

1. Tuition expenses;

2. Other reasonable educational expenses, and

3. Reasonable living expenses as estimated by the school as part of the school's standard student budget and determined reasonable by the department.

B. All loan award payments shall be applied only to outstanding educational loans secured while attending an approved nurse education program that led to RN, LPN, or CNA licensure. Qualifying outstanding educational loans shall:

1. Have sufficient documentation verifying the educational use of the loans;

2. Not exceed the "reasonable" level as determined by the school's standard budget in the year the loan was made; and

3. Not include loans from friends and relatives.

C. The department shall be the final authority in determining qualifying educational loans.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.6:01 and 54.1-3011.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 21, eff. July 13, 2016.

12VAC5-507-140 Release of information

Applicants shall agree to execute a release of information to allow the board access to loan records, credit information, and information from lenders necessary to verify eligibility and to determine loan repayments. To facilitate the process, applicants shall submit payment statements from each lending institution.

Participants who have consolidated qualifying loans with other loans shall submit on request other documentation, such as copies of original loan applications, to verify the portion of the loan that qualifies for repayment.

The applicant shall submit all requested loan documentation prior to approval by the department.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.6:01 and 54.1-3011.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 21, eff. July 13, 2016.

12VAC5-507-150 Effective date for start of service

Applicants shall become participants in the loan repayment program only when the applicant and the commissioner or his designee have signed the loan repayment program contract. The effective start date of the obligated service under the contract shall begin on or after the date of the commissioner's signature.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.6:01 and 54.1-3011.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 21, eff. July 13, 2016.

12VAC5-507-160 Repayment procedure

Loan repayment shall be limited to qualified loans as determined by 12VAC5-507-130. Repayment of loans shall begin after the commissioner has received notification that the participant has officially accepted placement and has begun the required service obligation. Payment shall be a lump sum payment based on availability of funds. Payment shall be made to the participant. Verification of payment made to the lender shall be required and submitted to the department by the participant. It shall be the responsibility of the participant to negotiate with each lending institution the terms of the educational loan repayments.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.6:01 and 54.1-3011.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 21, eff. July 13, 2016.

12VAC5-507-170 Compensation during service

Each participant is responsible for negotiating his own compensation package directly with the site where he will provide nursing services in a long-term care facility.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.6:01 and 54.1-3011.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 21, eff. July 13, 2016.

12VAC5-507-180 Monitoring during service

Monitoring of the participant's service obligation shall be conducted on an ongoing basis by department staff. Service verification forms shall be submitted by the participant to the department semi-annually (every six months) and countersigned by a representative of the service site (e.g., the medical director, human resource coordinator, chief executive officer, etc.) certifying continuous full-time service by the participant.

The participant shall maintain practice records in a manner that will allow the department to readily determine if the individual has complied with or is complying with the terms and conditions of the contract.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.6:01 and 54.1-3011.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 21, eff. July 13, 2016.

12VAC5-507-190 Terms of service

The following are the terms of service for the loan repayment program:

1. The applicant shall agree to provide full-time nursing services in a long-term care facility in the Commonwealth for a minimum of one year with an option for renewal in the second, third, and fourth year upon submitting a new application, with a potential to serve up to four years. Additional years of loan repayment beyond the one-year commitment are dependent upon the availability of state funds for the nursing loan repayment program;

2. The participant shall provide full-time service; and

3. No period of advanced training shall count toward satisfying a period of obligated service under this loan repayment program.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.6:01 and 54.1-3011.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 21, eff. July 13, 2016.

12VAC5-507-200 Loan repayment contract

Prior to becoming a participant in the nursing loan repayment program, the applicant shall enter into a contract with the commissioner agreeing to the terms and conditions upon which the loan repayment is granted. The contract shall:

1. Include the terms and conditions to carry out the purposes and intent of this program;

2. Provide that the participant shall provide full-time nursing services as an RN, LPN, or CNA in a long-term care facility in the Commonwealth for a minimum period of one year;

3. Provide for repayment of all amounts paid by the board, plus interest and penalties, less any service time if the participant is found to be in breach of contract;

4. Be signed by the applicant;

5. Be signed by the commissioner or his designee; and

6. Include other provisions as the commissioner may deem appropriate.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.6:01 and 54.1-3011.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 21, eff. July 13, 2016.

12VAC5-507-210 Breach of contract for loan repayment program

The following may constitute breach of contract:

1. Participant's failure to begin or complete his term of obligated service in a long-term care facility under the terms and conditions of the nursing loan repayment contract;

2. Participant's falsification or misrepresentation of information on the program application or verification forms or other required documents;

3. Participant's employment is terminated for good cause as determined by the employer and confirmed by the department. If employment is terminated for reasons beyond the participant's control (e.g., closure of site), the participant shall transfer to another board-approved long-term care facility site in the Commonwealth within six months of termination. Failure of participant to transfer to another site shall be deemed to be a breach of the contract; and

4. Participant's failure to provide the required nursing service in a long-term care facility.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.6:01 and 54.1-3011.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 21, eff. July 13, 2016.

12VAC5-507-220 Postponement or waiver of service for loan repayment program

Participants have the obligation to complete full-time continuous service for the period of their entire commitment. Under unusual circumstances (e.g., illness), a participant may request that the board agree to a postponement of the service obligation. This postponement, if granted, shall not relieve the participant of the responsibility to complete the remaining portion of the obligation. Such postponement shall not be permitted as a matter of course, but may be allowed in cases of undue hardship.

The board may grant a variance to service requirements or default repayments upon participant request if it finds compliance with the applicable service requirements or default repayment would pose an undue hardship on the participant.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.6:01 and 54.1-3011.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 21, eff. July 13, 2016.

12VAC5-507-230 Cash reimbursement and penalty for loan repayment program

Participants who serve less than their obligated service shall make repayment, including interest and penalty, to the Commonwealth as stated in the contract, reduced by the proportion of obligated years served.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.6:01 and 54.1-3011.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 21, eff. July 13, 2016.

12VAC5-507-240 Reporting requirements of loan repayment participants

Reporting requirements of the loan repayment participant are as follows:

1. Each participant shall provide information as required by the department to verify compliance with the practice requirements of the nursing loan repayment program (e.g., verification of employment in a long-term care facility by submitting a Verification of Employment form once every six months).

2. Each participant shall promptly notify the department in writing within 30 days if any of the following events occur:

a. Participant changes name;

b. Participant changes address;

c. Participant changes practice site (participant is required to request and obtain in writing prior approval of changes in practice site);

d. Participant no longer intends to fulfill service obligation as a nurse in the Commonwealth in a long-term care facility; or

e. Participant ceases to practice as a registered nurse, licensed practical nurse, or certified nurse aide.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.6:01 and 54.1-3011.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 21, eff. July 13, 2016.

Chapter 508 Regulations Governing the Virginia Physician Loan Repayment Program

Part I Definitions

12VAC5-508-10 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Approved residency" means a graduate medical education program in family practice medicine, general internal medicine, pediatric medicine, or obstetrics and gynecology approved by the board. In determining whether a course of study is acceptable, the board may consider the reputation of the program and whether it is approved or accredited by (i) a regional or national educational or professional association, including such organizations as the Accreditation Council for Graduate Medical Education, Liaison Committee on Medical Education, Council on Postgraduate Training of the American Osteopathic Association, Council on Osteopathic College Accreditation, College of Family Physicians of Canada, Committee for the Accreditation of Canadian Medical Schools, Education Commission on Foreign Medical Graduates, or Royal College of Physicians and Surgeons of Canada, or their appropriate subsidiary agencies; (ii) any appropriate agency of the United States government; or (iii) any other organization approved by the board.

"Board" or "Board of Health" means the State Board of Health.

"Commercial loans" means loans made by banks, credit unions, savings and loan associations, insurance companies, schools, and either financial or credit institutions that are subject to examination and supervision in their capacity as lenders by an agency of the United States or of the state in which the lender has its principal place of business.

"Commissioner" means the State Health Commissioner.

"Department" means Virginia Department of Health.

"Full-time" means at least 32 hours per week for 45 weeks per year.

"Geriatrics fellowship" means a geriatrics subspecialty training program following residency approved by the board. In determining whether a course of study is acceptable, the board may consider the reputation of the program and whether it is approved or accredited by (i) a regional or national educational or professional association, including such organizations as the Accreditation Council for Graduate Medical Education, Liaison Committee on Medical Education, Council on Postgraduate Training of the American Osteopathic Association, Council on Osteopathic College Accreditation, College of Family Physicians of Canada, Committee for the Accreditation of Canadian Medical Schools, Education Commission on Foreign Medical Graduates, or Royal College of Physicians and Surgeons of Canada, or their appropriate subsidiary agencies; (ii) any appropriate agency of the United States government; or (iii) any other organization approved by the board.

"Health professional shortage area" or "HPSA" means anarea in Virginia designated by the U.S. Secretary of Health and Human Services as having a shortage of health professionals in accordance with the procedures of the Public Health Service Act (42 USC § 254e) and implementing regulations (42 CFR Part 5).

"Participant" means an eligible primary care physician or a physician currently employed in a geriatrics fellowship who enters into a contract with the commissioner and participates in the loan repayment program.

"Penalty" means twice the amount of all monetary payments paid to the participant, less any service obligation completed.

"Practice" means the practice of medicine by a participant in a geriatrics fellowship or in one of the designated primary care specialties in a specific area determined to fulfill the participant's loan repayment obligation.

"Primary care" means the specialties of family practice medicine, general internal medicine, pediatric medicine, and obstetrics and gynecology.

"Reasonable educational expenses" means the costs of education, exclusive of tuition, that are considered to be required by the school's degree program or an eligible program of study, such as fees for room, board, transportation and commuting costs, books, supplies, educational equipment and materials, and travel that was a part of the estimated student budget of the school in which the participant was enrolled.

"State or local institution" means any Virginia state agency or local government agency that may require services of a primary care practitioner. This includes, but is not limited to, the Department of Health, the Department of Behavioral Health and Developmental Services, the Department of Corrections, the Department of Juvenile Justice, and local community services boards.

"Virginia medically underserved area" or "VMUA" means an area in Virginia designated by the State Board of Health in accordance with the Rules and Regulations for the Identification of Medically Underserved Areas in Virginia (12VAC5-540) and § 32.1-122.5 of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-122.6:1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 26, Issue 11, eff. March 3, 2010; amended, Virginia Register Volume 32, Issue 20, eff. July 15, 2016.

12VAC5-508-20 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 26, Issue 11, eff. March 3, 2010; repealed, Virginia Register Volume 32, Issue 20, eff. July 15, 2016.

12VAC5-508-30 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 26, Issue 11, eff. March 3, 2010; repealed, Virginia Register Volume 32, Issue 20, eff. July 15, 2016.

Part II Administration of the Virginia Physician Loan Repayment Program

12VAC5-508-40 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 26, Issue 11, eff. March 3, 2010; repealed, Virginia Register Volume 32, Issue 20, eff. July 15, 2016.

12VAC5-508-50 Eligible applicants

Eligible applicants for the Virginia Physician Loan Repayment Program shall:

1. Be a United States citizen, national, or a qualified alien pursuant to 8 USC § 1621;

2. Have graduated from an accredited medical school;

3. Be an allopathic (M.D.) or osteopathic (D.O.) physician who is enrolled in the final year of an approved residency program in allopathic medicine or osteopathic medicine, or already in practice, and who will have completed post-graduate training in an approved residency or be employed or accepted in a geriatrics fellowship when the period of obligated service begins;

4. Have a valid unrestricted Virginia license to practice medicine, a copy of which shall be furnished to the Virginia Physician Loan Repayment Program;

5. Have submitted a completed application to participate in the Virginia Physician Loan Repayment Program;

6. Have no other contractual service obligation unless completely satisfied before the physician loan repayment program contract has been signed;

7. Not have an active military obligation;

8. Be employed or have a contract for employment in an HPSA, a VMUA, an approved geriatrics fellowship, or a state or local institution within a month of the completion of the approved residency program or within a month of the application date, whichever is later;

9. Not have a history of failing to comply with, or inability to comply with, service or payment obligations;

10. Not have a history of noncompliance within any other state or federal scholarship or loan repayment program; and

11. Have an educational loan balance that can be verified.

History

• Statutory Authority: §§ 32.1-12 and 32.1-122.6:1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 26, Issue 11, eff. March 3, 2010; amended, Virginia Register Volume 32, Issue 20, eff. July 15, 2016.

12VAC5-508-60 Application requirement

The applicant shall submit a completed application for loan repayment, including documentation of eligibility requirements, to the Virginia Physician Loan Repayment Program, and the application shall be received in the department by July 31. The application form shall be available on the department's website.

History

• Statutory Authority: §§ 32.1-12 and 32.1-122.6:1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 26, Issue 11, eff. March 3, 2010; amended, Virginia Register Volume 32, Issue 20, eff. July 15, 2016.

12VAC5-508-70 Selection criteria

Applicants shall be competitively reviewed and selected for participation in the Virginia Physician Loan Repayment Program based upon the following criteria:

1. Commitment to serve. The individual's stated commitment to serve in an HPSA, a VMUA, an approved geriatrics fellowship, or a state or local institution.

2. Virginia residents or Virginia graduates. Preferential consideration shall be given to individuals who are or have been Virginia residents or graduates of Virginia medical schools (verification shall be obtained by the Virginia Physician Loan Repayment Program).

3. Residents of HPSAs or VMUAs. Preferential consideration shall be given to individuals who reside in HPSAs or VMUAs (verification shall be obtained by the Virginia Physician Loan Repayment Program).

4. Availability for service. Individuals who are immediately eligible and available for service shall be given higher consideration.

5. Length of proposed commitment. Preferential consideration shall be given to individuals who commit to longer periods of service.

6. Selection for participation. All of an individual's professional qualifications and competency to practice in an underserved area shall be considered, including board eligibility or specialty certification, professional achievements, and other indicators of competency received from supervisors, program directors, or other individuals who have agreed to enter into an employment contract with the individual.

History

• Statutory Authority: §§ 32.1-12 and 32.1-122.6:1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 26, Issue 11, eff. March 3, 2010; amended Virginia Register Volume 32, Issue 20, eff. July 15, 2016.

12VAC5-508-75 Loans qualifying for repayment

A. Based on the availability of funds, the loan repayment program shall pay for the cost of education necessary to obtain a medical degree. The program shall pay toward the outstanding principal, interest, and related expense of verifiable federal, state, or local government loans and commercial loans obtained by the participant for:

1. Tuition expenses; and

2. Other reasonable educational expenses.

B. All loan repayment awards shall be applied only to outstanding educational loans secured while attending an accredited medical school. Qualifying outstanding educational loans shall:

1. Have sufficient documentation verifying the educational use of the loans;

2. Not exceed the "reasonable" levels as determined by the school's standard budget in the year the loan was made; and

3. Not include loans from friends and relatives.

C. The department shall be the final authority in determining qualifying educational loans.

History

• Statutory Authority: §§ 32.1-12 and 32.1-122.6:1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 20, eff. July 15, 2016.

12VAC5-508-80 Loan repayment terms

A. Repayment of loans shall begin after the commissioner has received notification that the participant has officially accepted placement and has begun the required service obligation.

B. The applicant shall agree to serve a minimum of two years for a loan repayment amount of up to $60,000 with an option for a renewal in the third and fourth years. Renewals shall only be granted if the applicant can show a reduction in his educational loan balances. The loan repayment amount shall depend upon availability of funds and the applicant's indebtedness. In no event shall the amount of the loan repayment exceed the total indebtedness.

C. Payment shall be a lump-sum payment. Payment shall be made to the participant. A participant shall be paid one lump sum payment of up to $60,000 the first year for the minimum two-year commitment. If a participant commits to a service obligation greater than two years, he shall be paid a lump sum payment of up to $40,000 each following year depending on the availability of funds.

D. The maximum number of years of participation in the loan repayment program to which a participant may commit is four years. Verification of payment made to the lender shall be required and submitted to the department. It shall be the responsibility of the participant to negotiate with each lending institution the terms of the educational loan repayments.

History

• Statutory Authority: §§ 32.1-12 and 32.1-122.6:1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 26, Issue 11, eff. March 3, 2010; amended, Virginia Register Volume 32, Issue 20, eff. July 15, 2016.

12VAC5-508-90 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 26, Issue 11, eff. March 3, 2010; repealed, Virginia Register Volume 32, Issue 20, eff. July 15, 2016.

12VAC5-508-100 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 26, Issue 11, eff. March 3, 2010; repealed, Virginia Register Volume 32, Issue 20, eff. July 15, 2016.

12VAC5-508-110 Release of information

A. Applicants shall agree to execute a release of information to allow the department access to loan records, credit information, and information from lenders necessary to verify eligibility and to determine loan repayments. To facilitate the process, applicants shall submit payment statements from each lending institution.

B. Participants who have consolidated qualifying loans with other loans shall submit upon request other documentation, such as copies of original loan applications, to verify the portion of the loan that qualifies for repayment.

C. The applicant shall submit all requested loan documentation prior to approval by the department.

History

• Statutory Authority: §§ 32.1-12 and 32.1-122.6:1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 26, Issue 11, eff. March 3, 2010; amended, Virginia Register Volume 32, Issue 20, eff. July 15, 2016.

12VAC5-508-120 Practice site

All sites eligible for a participant's loan repayment service obligation shall be located in an HPSA, a VMUA, an approved geriatrics fellowship, or a state or local institution. The department shall publish a list of preapproved areas on the department's website.

History

• Statutory Authority: §§ 32.1-12 and 32.1-122.6:1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 26, Issue 11, eff. March 3, 2010; amended, Virginia Register Volume 32, Issue 20, eff. July 15, 2016.

12VAC5-508-130 Effective date for start of service

Applicants shall become participants in the loan repayment program only when the applicant and the commissioner or his designee have signed the loan repayment program contract. The effective start date of the obligated service under the contract is the date of employment or the date of the commissioner's signature on the contract, whichever is later.

History

• Statutory Authority: §§ 32.1-12 and 32.1-122.6:1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 26, Issue 11, eff. March 3, 2010; amended, Virginia Register Volume 32, Issue 20, eff. July 15, 2016.

12VAC5-508-135 Terms of service

The following are the terms of service for the loan repayment program:

1. The participant shall contract to provide a minimum of two years of the required service with a maximum of four years in whole year increments. Additional service beyond the two-year commitment is dependent upon the availability of state funds for the Virginia Physician Loan Repayment Program. An existing contract may be renewed for one year at a time up to a maximum of four years, as funds become available.

2. The participant shall provide full-time service.

3. No period of internship, residency, or other advanced clinical training, except an approved geriatrics fellowship, may count toward satisfying a period of obligated service under this loan repayment program.

History

• Statutory Authority: §§ 32.1-12 and 32.1-122.6:1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 20, eff. July 15, 2016.

12VAC5-508-140 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 26, Issue 11, eff. March 3, 2010; repealed, Virginia Register Volume 32, Issue 20, eff. July 15, 2016.

12VAC5-508-150 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 26, Issue 11, eff. March 3, 2010; repealed, Virginia Register Volume 32, Issue 20, eff. July 15, 2016.

12VAC5-508-160 Compensation during service

Each participant shall be responsible for negotiating his own compensation package directly with the site where he will provide primary health care services.

History

• Statutory Authority: §§ 32.1-12 and 32.1-122.6:1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 26, Issue 11, eff. March 3, 2010; amended, Virginia Register Volume 32, Issue 20, eff. July 15, 2016.

12VAC5-508-165 Conditions of practice

A. The participant shall agree to provide health services without discrimination, regardless of a patient's ability to pay. Payments from Medicare and Medicaid shall be accepted by the designated practice site.

B. The participant shall agree to comply with all policies, rules, and regulations of the designated practice site.

History

• Statutory Authority: §§ 32.1-12 and 32.1-122.6:1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 20, eff. July 15, 2016.

12VAC5-508-170 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 26, Issue 11, eff. March 3, 2010; repealed, Virginia Register Volume 32, Issue 20, eff. July 15, 2016.

12VAC5-508-175 Change of practice site

Should any participant find that he is unable to fulfill the required service commitment at the practice site to which he has committed to practice, he may request approval of a change of practice site. Such requests shall be made in writing. The commissioner in his discretion may approve such a request. All practice sites, including changes of practice sites, shall be selected with the approval of the commissioner.

In the event of a dispute between the participant and the practice site, every effort shall be made to resolve the dispute before reassignment will be permitted.

History

• Statutory Authority: §§ 32.1-12 and 32.1-122.6:1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 20, eff. July 15, 2016.

12VAC5-508-180 Monitoring during service

Monitoring of the participant's service obligation shall be conducted on an ongoing basis by department staff. Service verification forms shall be submitted by the participant to the department semi-annually (every six months) and countersigned by a representative of the service site (e.g., the medical director, human resource coordinator, or chief executive officer), certifying continuous full-time service by the participant.

The participant shall maintain practice records in a manner that will allow the department to readily determine if the individual has complied with or is complying with the terms and conditions of the contract. Department staff reserves the right to conduct a regular survey to ensure that all participants are maintaining practices that accept Medicare and Medicaid assignment and do not discriminate based on the patient's ability to pay.

History

• Statutory Authority: §§ 32.1-12 and 32.1-122.6:1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 26, Issue 11, eff. March 3, 2010; amended, Virginia Register Volume 32, Issue 20, eff. July 15, 2016.

12VAC5-508-190 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 26, Issue 11, eff. March 3, 2010; repealed, Virginia Register Volume 32, Issue 20, eff. July 15, 2016.

12VAC5-508-200 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 26, Issue 11, eff. March 3, 2010; repealed, Virginia Register Volume 32, Issue 20, eff. July 15, 2016.

12VAC5-508-210 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 26, Issue 11, eff. March 3, 2010; repealed, Virginia Register Volume 32, Issue 20, eff. July 15, 2016.

Part III Contract

12VAC5-508-220 Loan repayment contract

Prior to becoming a participant in the Virginia Physician Loan Repayment Program, the applicant shall enter into a contract with the commissioner agreeing to the terms and conditions upon which the loan repayment is granted. The contract shall:

1. Include the terms and conditions to carry out the purposes and intent of this program;

2. Provide that the participant shall be required to (i) provide primary health care services at an approved site in an HPSA, a VMUA, or a state or local institution for a minimum period of two years or (ii) be employed in an approved geriatrics fellowship for a minimum of two years. All loan repayment program participation shall be contingent upon continuous, full-time practice in an HPSA, a VMUA, an approved geriatrics fellowship, or a state or local institution;

3. Provide for repayment of all amounts paid, plus interest and penalties, less any service time in the event of breach of the contract;

4. Be signed by the applicant; and

5. Be signed by the commissioner or his designee.

History

• Statutory Authority: §§ 32.1-12 and 32.1-122.6:1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 26, Issue 11, eff. March 3, 2010; amended, Virginia Register Volume 32, Issue 20, eff. July 15, 2016.

12VAC5-508-230 Breach of contract

A. The following may constitute breach of contract:

1. Participant's failure to begin or complete his term of obligated service under the terms and conditions of the Virginia Physician Loan Repayment Program contract, regardless of the length of the agreed period of obligated service;

2. Participant's falsification or misrepresentation of information on the program application or verification forms or other required documents; or

3. Termination of participant's employment for good cause, as determined by the employer and confirmed by the department. If employment is terminated for reasons beyond the participant's control (e.g., closure of site), the participant shall transfer to another approved site in an HPSA, a VMUA, an approved geriatrics fellowship, or a state or local institution within six months of termination. Failure of the participant to find a transfer site within this time limit shall be deemed to be a breach of the contract.

B. In the event of a breach of contract, the participant shall make default payments as described in 12VAC5-508-260 and in accordance with the terms of the contract. In the event of a breach of contract where the participant has partially fulfilled his obligation, the total amount of reimbursement shall be prorated by the proportion of obligation completed.

History

• Statutory Authority: §§ 32.1-12 and 32.1-122.6:1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 26, Issue 11, eff. March 3, 2010; amended, Virginia Register Volume 32, Issue 20, eff. July 15, 2016.

12VAC5-508-240 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 26, Issue 11, eff. March 3, 2010; repealed, Virginia Register Volume 32, Issue 20, eff. July 15, 2016.

12VAC5-508-250 Deferment or waiver of service

A. Participants have the obligation to complete full-time continuous service for the period of their commitment. Under unusual circumstances as described in subsection B of this section, a participant may request that the board agree to a deferment of the service obligation. This deferment, if granted, shall not relieve the participant of the responsibility to complete the remaining portion of the obligation. Such deferment shall not be permitted as a matter of course, but may be allowed in the most compelling cases.

B. Individual cases may be considered by the board for a variance of payment or service, pursuant to § 32.1-12 of the Code of Virginia, if it finds compliance with the applicable service requirements or default repayment would pose an undue hardship on the participant.

C. If the participant is in default due to death or disability so as not to be able to engage in medical practice in an HPSA, a VMUA, an approved geriatrics fellowship, or a state or local institution in the Commonwealth, the participant or his personal representative may be relieved of his obligation under the contract to engage in medical practice, upon repayment to the Commonwealth of the total amount of loan repayment received plus interest and penalty as stated in the contract. For participants completing part of the required service obligation prior to becoming permanently disabled or in the event of death, the total amount of loan repayment funds owed shall be reduced by the proportion of obligated years served. The obligation to make restitution may be waived by the board upon application of the participant or the participant's representative to the board.

D. All requests for deferments, waivers, or variances must be submitted in writing to the department for consideration and final disposition by the board.

History

• Statutory Authority: §§ 32.1-12 and 32.1-122.6:1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 26, Issue 11, eff. March 3, 2010; amended, Virginia Register Volume 32, Issue 20, eff. July 15, 2016.

12VAC5-508-260 Cash reimbursement and penalty

Participants who serve less than their obligated service shall be liable for repayment, including interest and penalty, to the Commonwealth as stated in the contract, reduced by the proportion of obligated years served.

History

• Statutory Authority: §§ 32.1-12 and 32.1-122.6:1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 26, Issue 11, eff. March 3, 2010; amended, Virginia Register Volume 32, Issue 20, eff. July 15, 2016.

Part IV Records and Reporting

12VAC5-508-270 Reporting requirements

Reporting requirements of the participant are as follows:

1. Each participant shall at any time provide information as required by the department to verify compliance with the practice requirements of the Virginia Physician Loan Repayment Program.

2. Each participant shall promptly notify the department, in writing, within 30 days of any of the following events:

a. Participant changes name;

b. Participant changes address;

c. Participant changes practice site;

d. Participant no longer intends or is no longer able to fulfill service obligation as a primary care health care provider in an HPSA, a VMUA, an approved geriatrics fellowship, or a state or local institution; or

e. Participant ceases to practice as a physician.

History

• Statutory Authority: §§ 32.1-12 and 32.1-122.6:1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 26, Issue 11, eff. March 3, 2010; amended, Virginia Register Volume 32, Issue 20, eff. July 15, 2016.

Chapter 520 Regulations Governing the Dental Scholarship and Loan Repayment Programs

Part I Definitions

12VAC5-520-10 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Accredited dental school" means any dental school in the United States receiving accreditation from the Commission on Dental Accreditation.

"Accredited residency" means an advanced dental education program in general or specialty dentistry accredited by the Commission on Dental Accreditation and approved by the American Dental Association.

"Board" or "Board of Health" means the State Board of Health.

"Commissioner" means the State Health Commissioner.

"Dental practice" means the practice of dentistry by a recipient in general or specialty dentistry in a geographic area determined to be fulfillment of the recipient's scholarship or loan repayment obligation or practice as a dentist within a designated state facility.

"Dental underserved area" means a geographic area in Virginia designated by the State Board of Health as a county or city in which the ratio of practitioners of dentistry to population is less than that for the Commonwealth as a whole as determined by the commissioner or a dental health professions shortage area using criteria described in Part II (12VAC5-520-80 et seq.) of this chapter.

"Dentist loan repayment program" means the program established by § 32.1-122.9:1 of the Code of Virginia that allocates funds appropriated in conjunction with the dental scholarship program to increase the number of dentists in underserved areas of Virginia.

"Designated state facility" means practice as a dentist in a facility operated by the Virginia Department of Health, Virginia Department of Behavioral Health and Developmental Services, Virginia Department of Juvenile Justice, or the Virginia Department of Corrections.

"Full-time dental practice" means the practice of dentistry for an average of a minimum of 32 hours per week excluding those exceptions enumerated in Part III (12VAC5-520-160 et seq.) of this chapter.

"Interest at the prevailing bank rate for similar amounts of unsecured debt" means the prime lending rate plus 2.0% as published in the Wall Street Journal on the first day of the month in which the decision to repay is communicated to the commissioner by the recipient or on the first day of the month that the commissioner determines the recipient to be in default.

"Loan repayment award" means an award paid to a dentist for dental school loans in an amount equivalent to the current in-state tuition and mandatory fees at Virginia Commonwealth University School of Dentistry, and for which the dentist is under a contractual obligation to repay through practice in an underserved area or designated state facility. This amount may be capped at the discretion of the commissioner.

"Practice of general or specialty dentistry" means the evaluation, diagnosis, prevention and treatment (nonsurgical, surgical or related procedures) of diseases, disorders and conditions of the oral cavity, maxillofacial and adjacent and associated structures and their impact on the human body.

"Restitution" means three times the award amount received plus interest at the prevailing bank rate for similar amounts of unsecured debt as set forth in this regulation, owed to the Commonwealth of Virginia by a scholarship or loan repayment recipient who is in default of his contractual obligation as provided for in this chapter.

"Scholarship award" means an amount equivalent to one year of in-state tuition and mandatory fees at Virginia Commonwealth University School of Dentistry for the academic year a student is enrolled and for which the dental student entered a contractual obligation to repay through practice in an underserved area or designated state facility. This amount may be capped at the discretion of the commissioner.

"Scholarship recipient" means an eligible dental student who enters into a contract with the commissioner and receives one or more scholarship awards from the Virginia Dental Scholarship Program.

"Specialty dentistry" means the advanced practice of dentistry in any specialty approved by the American Dental Association and accredited by the Commission on Dental Accreditation.

History

• Statutory Authority: § 32.1-122.9 of the Code of Virginia.
• Historical Notes: Derived from VR355-40-03 § 1.1, eff. December 1, 1979; amended, Virginia Register Volume 18, Issue 15, eff. May 8, 2002; Volume 29, Issue 3, eff. November 8, 2012.

12VAC5-520-20 Administration of program

The State Health Commissioner, as executive officer of the Board of Health, shall administer this program. Any requests for deviation from the prescribed definitions shall be considered on an individual basis by the board in regular session.

History

• Statutory Authority: §§ 32.1-122.9 and 32.1-122.9:1 of the Code of Virginia.
• Historical Notes: Derived from VR355-40-03 § 1.2, eff. December 1, 1979; amended, Virginia Register Volume 18, Issue 15, eff. May 8, 2002.

12VAC5-520-30 (Repealed.)

History

• Historical Notes: Derived from VR355-40-03 § 1.3, eff. December 1, 1979; amended, Virginia Register Volume 18, Issue 15, eff. May 8, 2002; Errata, 18:18 V.A.R. 2369 May 20, 2002; repealed, Volume 29, Issue 3, eff. November 8, 2012.

12VAC5-520-40 (Repealed.)

Historical Notes

Derived from VR355-40-03 §§ 2.1 to 3.3, eff. December 1, 1979; repealed, Virginia Register Volume 18, Issue 15, eff. May 8, 2002.

Part II Dental Underserved Area

12VAC5-520-80 Population and dentist data

In order to determine the population-to-dentist ratio, the commissioner shall:

1. Use the population data or projections from the United States Census for independent cities, counties and counties with independent cities within their boundaries;

2. Determine the number of practitioners of dentistry from data secured from the Virginia State Board of Dentistry and the American Dental Association, adjusting for those dentists licensed in Virginia but practicing in other states, the military and retired dentists with active licenses;

3. Calculate this ratio every five years; and

4. Include as dental underserved areas those cities and counties determined to be dental health professions shortage areas as defined by the Department of Health and Human Services or designated a federal shortage area for the practice of dentistry as outlined in 42 CFR 5.1.

History

• Statutory Authority: §§ 32.1-122.9 and 32.1-122.9:1 of the Code of Virginia.
• Historical Notes: Derived from VR355-40-03 § 4.1, eff. December 1, 1979; amended, Virginia Register Volume 18, Issue 15, eff. May 8, 2002.

12VAC5-520-90 (Repealed.)

Historical Notes

Derived from VR355-40-03 §§ 4.2 to 4,5, eff. December 1, 1979; repealed, Virginia Register Volume 18, Issue 15, eff. May 8, 2002.

Part III Scholarship and Loan Repayment Awards

12VAC5-520-130 Eligible applicants

A. Any currently enrolled dental student in good standing and full-time attendance at Virginia Commonwealth University School of Dentistry who has not entered the first year of an accredited residency shall be eligible for the Virginia Dental Scholarship Program. Preference for the scholarship award shall be given to residents of the Commonwealth, students who are residents of a dental underserved area, and students from economically disadvantaged backgrounds.

B. Any graduate of an accredited dental school in the United States who is establishing a practice in general or specialty dentistry in an underserved area or practicing dentistry in a designated state facility shall be eligible to apply for the Virginia Dentist Loan Repayment Program. General practice dentists will be within five years of graduation from an accredited undergraduate dental program and have existing loans accumulated as a result of their undergraduate dental program. Specialty practice dentists will be within five years of completion of their specialty training and have existing loans accumulated as a result of their undergraduate dental program. Dentists who received Virginia scholarship awards or other scholarships that paid their full tuition and fees are not eligible for the Dentist Loan Repayment Program for the years they received those awards.

History

• Statutory Authority: § 32.1-122.9 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 15, eff. May 8, 2002; amended, Virginia Register Volume 29, Issue 3, eff. November 8, 2012.

12VAC5-520-140 Scholarship and loan repayment award

A Virginia dental scholarship or loan repayment shall be awarded to the recipient upon or following the recipient's execution of a contract with the commissioner for scholarship or loan repayment by practicing dentistry in an underserved area or designated state facility as defined in this chapter.

History

• Statutory Authority: §§ 32.1-122.9 and 32.1-122.9:1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 15, eff. May 8, 2002.

12VAC5-520-150 Distribution of scholarships and loan repayment awards

The Virginia General Assembly establishes the total combined appropriation for the dental scholarship and dentist loan repayment programs. Funds shall be awarded for these programs based on the following criteria:

1. Virginia Commonwealth University School of Dentistry shall use the application procedure established by the commissioner and annually submit the names of qualified students to receive scholarships in accordance with the criteria for preference enumerated in 12VAC5-520-130. The total number of scholarship awards will be based on availability of funds. Scholarship awards will be made annually by October 30 to third-year and fourth-year dental students. First-year and second-year students will be considered for an award only in the event of extreme financial need. Individual scholarship recipients may receive a maximum of five scholarship awards.

2. The application period for the Dentist Loan Repayment Program will begin in October with awards made by the end of each fiscal year. Preference for loan repayment awards will be given to graduates of Virginia Commonwealth University School of Dentistry. Individual loan repayment recipients may receive a maximum of four awards upon graduation from dental school. All awards will be competitive and will be based on availability of funds.

History

• Statutory Authority: § 32.1-122.9 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 15, eff. May 8, 2002; amended, Virginia Register Volume 29, Issue 3, eff. November 8, 2012.

12VAC5-520-160 Contractual practice obligation

Prior to the payment of money to a scholarship or loan repayment recipient, the commissioner shall prepare and enter into a contract with the recipient. The contract shall:

1. Provide that the recipient of the scholarship award shall pursue the dental course of Virginia Commonwealth University until graduation and upon graduation or upon graduation from an accredited residency program that does not exceed four years, shall notify the commissioner in writing of his proposed practice location or intent to enter a residency not more than 30 days after graduation and begin his approved practice within 90 days after completing dental school or residency, and thereafter continuously engage in full-time dental practice in a dental underserved area of Virginia or in a designated state facility for a period of years equal to the number of annual scholarships received.

2. Provide that upon graduation from an accredited dental school and receiving notification of the dentist loan repayment award, the dentist shall begin his approved practice within 90 days and thereafter continuously engage in full-time dental practice in an underserved area of Virginia or in a designated state facility for a period of years equal to the number of loan repayment awards received.

3. Provide that at any time prior to entering practice, the scholarship or loan repayment recipient shall be allowed to select a future practice location from the listing of dental underserved areas maintained by the board.

4. Provide that the recipient may request approval of a change of practice location. The commissioner in his discretion may approve such a request, but only if the change is to a practice location in a dental underserved area or a state facility designated by the Board of Health.

5. Provide that the recipient shall repay the scholarship or loan repayment obligation by practicing dentistry on a full-time basis in a dental underserved area, shall maintain office hours convenient for the population of the area to have access to the recipient's services and shall participate in all government-sponsored insurance programs designed to ensure access to dental services of recipients of public assistance. The recipient shall not selectively place limits on the numbers of such patients admitted to the practice.

6. Provide that the recipient shall not voluntarily obligate himself for more than the minimum period of military service required of dentists by the laws of the United States and that upon completion of the minimum period of military service, the recipient shall promptly begin and thereafter continuously engage in full-time dental practice in a dental underserved area of Virginia or in a designated state facility for the period of years equal to the number of scholarships received. Dental practice in federal agencies, military service or the U.S. Public Health Service may not be substituted for scholarship obligation.

7. Provide that the recipient shall receive credit toward fulfillment of his contractual obligation at the rate of 12 months of dental practice for each scholarship or loan repayment award paid to the recipient. The recipient may be absent from the place of approved practice for a total of four weeks in each 12-month period for personal reasons. Absence for a period in excess of four weeks without the written permission of the commissioner shall result in proportional reduction of the period of credit toward fulfillment of the contractual obligation.

8. Provide that should the scholarship recipient pay restitution by not serving his scholarship obligation in an underserved area, and within five years of paying restitution fulfills the terms of his contract through dental practice as outlined in this section, that the recipient will be reimbursed for all or part of any scholarship award paid based on the fulfillment of the scholarship and availability of funds.

History

• Statutory Authority: § 32.1-122.9 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 15, eff. May 8, 2002; amended, Virginia Register Volume 29, Issue 3, eff. November 8, 2012.

Part IV Special Requests

12VAC5-520-170 Special requests for approval

Special requests for approval of the practice of dentistry in an area in which the ratio does not meet the definition of an area of need shall be considered by the Board of Health on an individual basis. To obtain the board's approval, the scholarship or loan repayment recipient shall substantiate to the board's satisfaction that the ratio does not correctly depict the provision of dental services in the city or county and that additional practitioners are necessary. Examples of situations deserving special consideration may include topography, age or physical health of dental practitioners in the area, and sub-areas of high density population that can be geographically identified and shown to have a ratio less than the state ratio.

History

• Statutory Authority: §§ 32.1-122.9 and 32.1-122.9:1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 15, eff. May 8, 2002.

Part V Special Circumstances

12VAC5-520-180 Fractional need

The Board of Health recognizes that instances will occur when the ratio of dental practitioners to population reflects a fractional share of need. In such instances and in recognition of the advantages that accrue to the dentist and the community from two or more dentists working in an associated or cooperative basis, the commissioner may in his discretion favorably consider the approval of an additional dentist in order to facilitate such an arrangement.

History

• Statutory Authority: § 32.1-122.9 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 15, eff. May 8, 2002; amended, Virginia Register Volume 29, Issue 3, eff. November 8, 2012.

Part VI Default

12VAC5-520-190 Default

A. With respect to default, the contract shall provide that a scholarship or loan repayment recipient who fails to fulfill his obligation to practice dentistry as described in 12VAC5-520-160 shall be deemed in default under the following circumstances and shall forfeit all monetary scholarship or loan repayment awards made to him and shall repay the Commonwealth of Virginia as provided for in this chapter. The contract shall:

1. Provide that if the scholarship recipient defaults while still in dental school, by voluntarily notifying the commissioner in writing that he will not practice dentistry in a Virginia dental underserved area as required by his contract, by voluntarily not proceeding to the next year of dental education, or by withdrawing from dental school, the student shall pay the Commonwealth of Virginia all monetary scholarship awards plus interest at the prevailing bank rate for similar amounts of unsecured debt.

2. Provide that the scholarship recipient who defaults by failing to maintain grade levels that will allow the dental student to graduate, or by reason of his dismissal from dental school for any reason, shall repay the Commonwealth of Virginia all monetary scholarship awards plus interest at the prevailing bank rate for similar amounts of unsecured debt.

3. Provide that if the scholarship or loan repayment recipient is in default due to death or permanent disability so as not to be able to engage in dental practice, the recipient or his personal representative shall repay the Commonwealth all monetary awards plus 8.0% interest on the amount of the award. Partial fulfillment of the recipient's contractual obligation by the practice of dentistry as provided for in this contract prior to death or permanent disability shall reduce the amount of repayment plus interest due by a proportionate amount of money, such proportion being determined as the ratio of the number of whole months that a recipient has practiced dentistry in an approved location to the total number of months of the contractual obligation the recipient has incurred. The commissioner may waive all or part of the scholarship or loan repayment obligation under application by the recipient or his estate under these conditions and consider whole or partial forgiveness of payment or service in consideration of individual cases of hardship or inability to pay.

4. Provide that any recipient of a scholarship or loan repayment who defaults by evasion or refusal to fulfill the obligation to practice dentistry in an underserved area or designated state facility for a period of years equal to the number of annual scholarships or loan repayment awards received shall make restitution to the Commonwealth of Virginia.

B. A scholarship or loan repayment recipient will be considered to be in such default on the date:

1. The commissioner is notified in writing by the recipient that he does not intend to fulfill his contractual obligation;

2. The recipient has not accepted a placement and commenced his period of obligated practice as provided for in subdivisions 1 and 2 of 12VAC5-520-160; or

3. The recipient absents himself without the consent of the commissioner from the place of dental practice that the commissioner has approved for fulfillment of his contractual obligation.

History

• Statutory Authority: § 32.1-122.9 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 15, eff. May 8, 2002; amended, Virginia Register Volume 29, Issue 3, eff. November 8, 2012.

Part VII Repayment

12VAC5-520-200 Repayment

Repayment requirements for scholarship and loan repayment recipients are as follows:

1. Payment of restitution or repayment of award plus interest shall be due on the date that the recipient is deemed by the commissioner to be in default.

2. The commissioner in his discretion shall permit extension of the period of repayment for up to 24 months from the date that the recipient is deemed to be in default.

3. Partial fulfillment of the recipient's contractual obligation by the practice of dentistry as provided for in this contract shall reduce the amount of restitution by a percentage based on the number of whole months that the recipient has practiced dentistry in an approved location and the total number of months of the contractual obligation the recipient has incurred.

4. Failure of a recipient to make any payment on his debt when it is due shall be cause for the commissioner to refer the debt to the Attorney General of the Commonwealth of Virginia for collection. The recipient shall be responsible for any costs of collection as may be provided in Virginia law.

History

• Statutory Authority: § 32.1-122.9 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 15, eff. May 8, 2002; amended, Virginia Register Volume 29, Issue 3, eff. November 8, 2012.

Part VIII Records and Reporting

12VAC5-520-210 Reporting requirements

Reporting requirements of Virginia Commonwealth University School of Dentistry scholarship and loan repayment recipients are as follows:

1. Virginia Commonwealth University School of Dentistry shall maintain accurate records of the status of scholarship recipients until the recipient's graduation from dental school. The dental school shall provide a report listing the status of each recipient annually to the commissioner.

2. Each scholarship and loan repayment recipient shall at any time provide information as requested by the commissioner to verify compliance with the practice requirements of the scholarship or loan repayment contract. The recipient shall report any changes of mailing address, change of academic standing, change of intent to fulfill his contractual obligation and any other information that may be relevant to the contract at such time as changes or information may occur. The recipient shall respond within 30 days with such information as may be requested by the commissioner.

History

• Statutory Authority: § 32.1-122.9 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 15, eff. May 8, 2002; amended, Virginia Register Volume 29, Issue 3, eff. November 8, 2012.

Chapter 530 Regulations Governing the Virginia Medical Scholarship Program

Part I General Information

12VAC5-530-10 Purpose

This chapter sets forth the criteria for eligibility, circumstances under which awards will be made, and the process for awarding Virginia medical scholarships to medical students; the general terms and conditions applicable to the obligation of each recipient of a medical scholarship to practice medicine in a medically underserved area of Virginia, as identified by the Board of Health by regulation, or to practice medicine in a designated state facility as defined in this chapter regulations; and penalties for a recipient's failure to fulfill the practice requirements of the Virginia Medical Scholarship Program.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.5, 32.1-122.5:1, 32.1-122.6, and 32.1-122.6:01 of the Code of Virginia.
• Historical Notes: Derived from VR355-40-400 § 1.2, eff. July 3, 1991; amended, Virginia Register Volume 10, Issue 21, eff. August 10, 1994.

12VAC5-530-20 Administration

The State Health Commissioner, as executive officer of the Board of Health, shall administer this program. Any requests for variance from this chapter shall be considered on an individual basis by the board in regular session.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.5, 32.1-122.5:1, 32.1-122.6, and 32.1-122.6:01 of the Code of Virginia.
• Historical Notes: Derived from VR355-40-400 § 1.3, eff. July 3, 1991; amended, Virginia Register Volume 11, Issue 10, eff. August 10, 1994.

12VAC5-530-30 Applicability

This chapter shall apply to all recipients who begin fulfillment of their scholarship obligation on July 1, 1990, or later; provided that approval given by the commissioner prior to the effective date of this chapter shall remain in full force and effect.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.5, 32.1-122.5:1, 32.1-122.6, and 32.1-122.6:01 of the Code of Virginia.
• Historical Notes: Derived from VR355-40-400 § 1.4, eff. July 3, 1991; amended, Virginia Register Volume 10, Issue 21, eff. August 10, 1994.

Part II Definitions

12VAC5-530-40 Definitions

Unless the context clearly indicates a contrary interpretation, the words and terms used in this chapter shall have the following meanings:

"Accredited residency" means a graduate medical education program in family practice medicine, general internal medicine, pediatric medicine or obstetrics and gynecology accredited by the Liaison Committee on Graduate Medical Education.

"Approved by the medical school that nominated him for the scholarship" means that medical school affirms that the graduate has accepted placement in an accredited residency or internship at a hospital or institution located in Virginia, or affirms that such placement has been accepted in a program not located in Virginia due to such placement through the match.

"Board" or "Board of Health" means the State Board of Health.

"Commissioner" means the State Health Commissioner.

"Designated state facility" means a facility operated by the Virginia Departments of Corrections, Youth and Family Services, or Mental Health, Mental Retardation and Substance Abuse Services.

"First year resident" means a graduate of a participating medical school who has been accepted by an accredited primary care residency program approved by the medical school that nominated him for the scholarship.

"Interest at the prevailing bank rate for unsecured debt" means the prime lending rate as published in the Wall Street Journal on the last day of the month in which the decision to repay is communicated to the commissioner by the recipient, plus two percentage points.

"The match" means the National Resident Matching Program, a nationwide system by which medical school graduates are placed in graduate medical education programs by mutual agreement.

"Medically underserved area" means a geographic area in Virginia designated by the State Board of Health in accordance with the rules and regulations for the identification of medically underserved areas.

"Participating medical school" means the Eastern Virginia Medical School of the Medical College of Hampton Roads, or the Medical College of Virginia of the Virginia Commonwealth University, or the School of Medicine of the University of Virginia, or the James H. Quillen College of Medicine of East Tennessee State University.

"Penalty" means an amount of money equal to two times the amount of all monetary scholarship awards paid to the scholarship recipient.

"Practice" means the practice of medicine by a recipient in one of the designated primary care specialties in a specific geographic area determined to be fulfillment of the recipient's scholarship obligation.

"Primary care" means the specialties of family practice medicine, general internal medicine, pediatric medicine, or obstetrics and gynecology.

"Recipient" or "scholarship recipient" means an eligible medical student or graduate medical student who enters into a contract with the commissioner and receives one or more scholarship awards via the Virginia Medical Scholarship Program.

"Restitution" means the amount of monetary reimbursement, including repayment of all pertinent scholarship awards plus penalty and applicable interest as set forth in this chapter, that will be owed to the Commonwealth of Virginia by a scholarship recipient who is in default of his contractual obligation as provided for in this chapter.

"Southwest Virginia" means those cities and counties in Virginia that are located in Planning Districts 1, 2, and 3; they include Bland County, City of Bristol, Buchanan County, Carroll County, Dickenson County, City of Galax, Grayson County, Lee County, City of Norton, Russell County, Scott County, Smyth County, Tazewell County, Washington County, Wise County, and Wythe County.

"Virginia medical scholarship" means an award of an amount specified by the General Assembly in the Appropriations Act made to a student enrolled in a participating medical school or to a graduate student of a participating medical school pursuing the first year of graduate training at a hospital or institution approved by the participating medical school that nominated him for the scholarship and for which the medical student or graduate medical student entered a contractual obligation to repay.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.5, 32.1-122.5:1, 32.1-122.6, and 32.1-122.6:01 of the Code of Virginia.
• Historical Notes: Derived from VR355-40-400 § 2.1, eff. July 3, 1991; amended, Virginia Register Volume 10, Issue 21, eff. August 10, 1994.

Part III Scholarship Awards

12VAC5-530-50 Eligible applicants

Any currently enrolled student in full-time attendance at a participating medical school or a graduate of such school who has accepted placement in, but not entered the first year of an accredited internship or accredited residency approved by the medical school that nominated him for the scholarship, shall be eligible for the Virginia medical scholarship. Preference for the scholarship award shall be given to: residents of the Commonwealth, students whose period of residence in one or more medically underserved areas is deemed by the participating medical school to indicate a high likelihood that the student would fulfill his contractual obligation to practice in a medically underserved area, and students from economically disadvantaged backgrounds over nonresidents. Additionally, preference shall be given to graduates accepted by approved primary care residencies in Virginia over graduates in approved out-of-state residencies. Virginia medical scholarships are available for medical students who are enrolled at the James H. Quillen College of Medicine of East Tennessee State University when such individuals are determined to be committed to practicing in a medically underserved area in Southwest Virginia. Preference for the scholarship award shall be given to residents of Southwest Virginia.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.5, 32.1-122.5:1, 32.1-122.6, and 32.1-122.6:01 of the Code of Virginia.
• Historical Notes: Derived from VR355-40-400 § 3.1, eff. July 3, 1991; amended, Virginia Register Volume 10, Issue 21, eff. August 10, 1994.

12VAC5-530-60 Scholarship award

A Virginia medical scholarship award shall be awarded to the recipient upon or following the recipient's execution of a contract with the commissioner for scholarship repayment.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.5, 32.1-122.5:1, 32.1-122.6, and 32.1-122.6:01 of the Code of Virginia.
• Historical Notes: Derived from VR355-40-400 § 3.2, eff. July 3, 1991; amended, Virginia Register Volume 10, Issue 21, eff. August 10, 1994.

12VAC5-530-70 Distribution of scholarships

Annually, by May 1 of each calendar year, the commissioner shall inform the deans of the participating medical schools of the number as provided by the General Assembly by appropriation of medical school scholarships that are available for the schools' medical students during the next academic year. The annual number of medical scholarships available for award at each participating medical school shall be uniformly distributed among the schools, and shall be equal, and shall be based upon funds appropriated by the Virginia General Assembly, except that the number of Virginia medical scholarships available for medical students from Southwest Virginia attending the James H. Quillen College of Medicine of East Tennessee State University shall be limited to the number established by the Virginia General Assembly by appropriation. The deans of the respective participating medical schools shall annually nominate qualified students or first-year residents, in accordance with the criteria for preference enumerated in 12VAC5-530-50, to receive scholarships. The number of nominees submitted to the commissioner at this time will not exceed the number of scholarships that are available for each medical school. The State Health Commissioner shall award scholarships to the nominees of the deans at the participating medical schools in accordance with the number of scholarships available for each medical school. Any scholarships that have not been awarded following the initial annual distribution among the medical schools shall be available for redistribution to qualified students in any of the medical schools at the discretion of an awards committee consisting of the commissioner, who shall serve as chairman and ex officio member without vote, and the deans of the medical schools or their designees. The awards committee shall convene for this purpose only when the scholarships available to one or more of the medical schools exceed the number of qualified nominees by the dean(s). Scholarships shall be awarded to qualified students based upon majority vote of the awards committee. Individual scholarship recipients may be nominated for and receive a maximum of five scholarships.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.5, 32.1-122.5:1, 32.1-122.6, and 32.1-122.6:01 of the Code of Virginia.
• Historical Notes: Derived from VR355-40-400 § 3.3, eff. July 3, 1991; amended, Virginia Register Volume 10, Issue 21, eff. August 10, 1994.

Part IV Contracts

12VAC5-530-80 Contractual practice obligation

Prior to the payment of money to a scholarship awardee, the commissioner shall enter into a contract with the recipient. The contract shall:

1. Provide that the recipient will pursue the medical course of the school nominating the recipient for the award until the recipient's graduation or will pursue the recipient's first year of primary care graduate training in an accredited residency program approved by the school nominating the recipient for the award and, upon completing a term not to exceed three* years as a resident in an approved program, will promptly begin and thereafter continuously engage in full-time primary care practice in a medically underserved area of Virginia, or in a designated state facility, for a period of years equal to the number of annual scholarships received. At any time prior to entering practice, the scholarship recipient shall be allowed to select a future practice location from the listing of medically underserved areas maintained by the board, and the recipient shall be allowed to fulfill the scholarship repayment obligation in the preselected medically underserved area. However, after making an initial selection of a medically underserved area in which to practice, the recipient may not alter the decision until the recipient is fully prepared to enter practice, at which time the recipient must choose from the current list of medically underserved areas maintained by the board or the preselected medically underserved area.

2. Provide that the recipient shall notify the commissioner in writing of his proposed practice location not more than 30 days after completing his approved residency program. After receiving written approval of his practice location from the commissioner, the recipient shall begin his approved practice not more than 90 days after completing his primary care residency program.

3. Provide that the recipient may request approval of a change of practice location. The commissioner in his discretion may approve such a request, but only if the change is to a practice location in a medically underserved area or a state facility designated by the Board of Health.

4. Provide that the recipient shall repay the scholarship obligation by practicing primary care medicine on a full-time basis in a medically underserved area, will maintain office hours convenient for the population of the area to have access to the recipient's services and will participate in all government sponsored insurance programs designed to assure access of covered persons to medical care services such as Medicare and Medicaid, and will not selectively place limits on the numbers of such patients admitted to the practice, and will charge the usual and customary fees prevailing in the area in which service is provided, except that if the patient is unable to pay the charge, such a patient will be charged a reduced rate or will not be charged at all. This stipulation may be waived at the commissioner's discretion in cases where it places undue financial burden on the part of the primary care medical practice.

5. Provide that the recipient repaying the scholarship obligation by practicing primary care medicine on a full-time basis in a medically underserved area will maintain office hours convenient for the population of the area to have access to the recipient's services.

6. Provide that the recipient shall not voluntarily obligate himself for more than the minimum period of military service required of physicians by the laws of the United States and that upon completion of the minimum period of military service, the recipient will promptly begin and thereafter continuously engage in full-time primary care practice in a medically underserved area of Virginia, or in a designated state facility, for the period of years equal to the number of scholarships received.

7. Provide that the recipient shall receive credit toward fulfillment of his contractual obligation at the rate of 12 months of medical practice for each scholarship award paid to the recipient. The recipient may be absent from the place of approved practice for a total of seven weeks in each 12-month period for personal reasons. Absence for a period in excess of seven weeks without the written permission of the commissioner shall result in proportional reduction of the period of credit toward fulfillment of the contractual obligation.

*NOTE: A variance (of one additional year) to the maximum three-year residency limitation will be available to medical scholarship recipients who choose to complete an obstetrics/gynecology residency program or a certificate of added qualification in primary care upon their request.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.5, 32.1-122.5:1, 32.1-122.6, and 32.1-122.6:01 of the Code of Virginia.
• Historical Notes: Derived from VR355-40-400 § 4.1, eff. July 3, 1991; amended, Virginia Register Volume 10, Issue 21, eff. August 10, 1994.

12VAC5-530-90 Default

With respect to default, the contract shall:

1. Provide that a recipient who fails to fulfill his obligation to practice primary care medicine as provided for in this chapter shall be deemed to be in default and shall forfeit all monetary scholarship payments made to him, and shall make restitution of those funds to the Commonwealth of Virginia as provided for in subdivisions 2 through 6 of this section.

2. Provide that if the recipient defaults while still in medical school or residency, by voluntarily notifying the commissioner in writing that he will not practice primary care in a Virginia medically underserved area as required by his contract, by voluntarily not proceeding to the next year of medical education or residency, or by withdrawing from medical school or residency, he shall make restitution to the Commonwealth of Virginia by repayment of all monetary scholarship awards plus interest on the amount of the restitution.

3. Provide that the recipient who defaults by failing to maintain satisfactory academic progress, or by reason of his dismissal from medical school for any reason, shall make restitution to the Commonwealth of Virginia by repayment of all monetary scholarship awards plus interest on the amount of such restitution to the Commonwealth.

4. Provide that if the recipient is in default due to death or permanent disability so as not to be able to engage in primary care practice, the recipient or his personal representative shall make restitution to the Commonwealth by repayment of all monetary scholarship awards plus interest on the amount of restitution. Partial fulfillment of the recipient's contractual obligation by the practice of medicine as provided for in this contract prior to death or permanent disability shall reduce the amount of restitution plus interest due by a proportionate amount of money, such proportion being determined as the ratio of the number of whole months that a recipient has practiced primary care medicine in an approved location to the total number of months of the contractual obligation the recipient has incurred.

5. Provide that individual cases of extraordinary hardship may be considered by the commissioner for forgiveness or partial forgiveness of payment or service.

6. Provide that any recipient of a scholarship, who defaults by evasion or refusal to fulfill the obligation to practice primary care medicine in a medically underserved area or designated state facility for a period of years equal to the number of annual scholarships received at any time following completion of medical school and residency training, shall make restitution by repaying all monetary scholarship awards, plus penalty, plus interest on such restitution to the Commonwealth of Virginia. A recipient will be considered to be in such default on the date:

a. The commissioner is notified in writing by the recipient that he does not intend to fulfill his contractual obligation;

b. The recipient has not accepted a placement and commenced his period of obligated practice as provided for in subdivision 2 of this section; or

c. The recipient absents himself without the consent of the commissioner from the place of medical practice which the commissioner has approved for fulfillment of his contractual obligation.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.5, 32.1-122.5:1, 32.1-122.6, and 32.1-122.6:01 of the Code of Virginia.
• Historical Notes: Derived from VR355-40-400 § 4.2, eff. July 3, 1991; amended, Virginia Register Volume 10, Issue 21, eff. August 10, 1994.

Part V Repayment

12VAC5-530-100 Repayment

Repayment requirements for scholarship recipients are as follows:

1. Payment of restitution plus interest shall be due on the date that the recipient is deemed by the commissioner to be in default.

2. The commissioner in his discretion may permit extension of the period of payment of restitution plus interest for up to 24 months from the date that the recipient is deemed to be in default.

3. Partial fulfillment of the recipient's contractual obligation by the practice of medicine as provided for in this contract, shall reduce the amount of restitution plus interest due by an amount of money equal to the same percentage of all monetary awards as the number of whole months that the recipient has practiced primary care medicine in an approved location is as a percentage of the total number of months of the contractual obligation the recipient has incurred.

4. Failure of a recipient to make any payment on his debt of restitution plus interest when it is due shall be cause for the commissioner to refer the debt to the Attorney General of the Commonwealth of Virginia for collection. The recipient shall be responsible for any costs of collection as may be provided in Virginia law.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.5, 32.1-122.5:1, 32.1-122.6, and 32.1-122.6:01 of the Code of Virginia.
• Historical Notes: Derived from VR355-40-400 § 5.1, eff. August 10, 1994; amended, Virginia Register Volume 10, Issue 21, eff. August 10, 1994.

Part VI Records and Reporting

12VAC5-530-110 Reporting requirements

Reporting requirements of medical schools and scholarship recipients are as follows:

1. Each participating medical school shall maintain accurate records of the status of scholarship recipients until the recipients graduate from medical school and during any postgraduate year that a scholarship is awarded. The medical schools shall provide a report listing the status of each recipient annually to the commissioner.

2. Each scholarship recipient shall at any time provide information as requested by the commissioner to verify compliance with the practice requirements of the scholarship contract. The recipient shall report any changes of mailing address, change of academic standing, change of intent to fulfill his contractual obligation and any other information which may be relevant to the contract at such time as changes or information may occur. The recipient shall promptly respond with such information as may from time to time be requested by the commissioner.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.5, 32.1-122.5:1, 32.1-122.6, and 32.1-122.6:01 of the Code of Virginia.
• Historical Notes: Derived from VR355-40-400 § 5.1, eff. July 3, 1991; amended, Virginia Register Volume 10, Issue 21, eff. August 10, 1994.

Chapter 540 Rules and Regulations for the Identification of Medically Underserved Areas in Virginia

Part I General Information

12VAC5-540-10 Authority

In accordance with the provisions of § 32.1-122.5 of the Code of Virginia, the State Board of Health is required to establish criteria for determining medically underserved areas within the Commonwealth and include in these criteria the need for medical care services in the state facilities operated by the Departments of Corrections, Juvenile Justice, and Behavioral Health and Developmental Services. The criteria are required to be quantifiable measures, sensitive to the unique characteristics of urban and rural jurisdictions.

History

• Statutory Authority: §§ 32.1-12 and 32.1-122.5 of the Code of Virginia.
• Historical Notes: Derived from VR355-40-500 § 1.1, eff. July 3, 1991; amended, Virginia Register Volume 32, Issue 7, eff. December 30, 2015.

12VAC5-540-20 Purpose

The purpose of identifying medically underserved areas within the Commonwealth is to establish geographic areas in need of additional primary health care services. Further, these medically underserved areas may become eligible for assistance to establish primary care medical centers.

History

• Statutory Authority: §§ 32.1-12 and 32.1-122.5 of the Code of Virginia.
• Historical Notes: Derived from VR355-40-500 § 1.2, eff. July 3, 1991; amended, Virginia Register Volume 32, Issue 7, eff. December 30, 2015.

Part II Designating Medically Underserved Areas

12VAC5-540-30 Criteria for determining medically underserved areas

The following five criteria, as available, and as indicated, shall be used to evaluate and identify medically underserved areas throughout the Commonwealth of Virginia:

1. Percentage of population with income at or below 100% of the federal poverty level. The source for these data shall be the most recent available publication of the Bureau of the Census of the U.S. Department of Commerce.

2. Percentage of population that is 65 years of age or older. The source for these data shall be the Economic Services Division of the Virginia Employment Commission.

3. The primary care physician to population ratio. The source for these data shall be the Department of Family Practice of the Medical College of Virginia of Virginia Commonwealth University.

4. The four-year aggregate infant mortality rate. The source for these data shall be the Center of Health Statistics of the Virginia Department of Health.

5. The most recent annual civilian unemployment rate. The source for these data shall be Information Services Division of the Virginia Employment Commission.

History

• Statutory Authority: §§ 32.1-12 and 32.1-122.5 of the Code of Virginia.
• Historical Notes: Derived from VR355-40-500 § 2.1, eff. July 3, 1991.

12VAC5-540-40 Application of the criteria

A. Determining medically underserved cities and counties. The criteria enumerated in 12VAC5-540-30 shall be used to construct a numerical index by which the relative degree of medical underservice shall be calculated for each city and county within the Commonwealth. Observations for each of the criteria will be listed for each Virginia city and county. An interval scale will be used to assign a particular value to each observation. This will be done for each of the criteria. Each interval scale will consist of four ranges or outcomes of observations. The ranges will be numerically equal. The four ranges will be labeled as Level 1, Level 2, Level 3, and Level 4. The numerical difference between the ranges will be established beginning with the Level 2 range.

The Level 2 range shall have the statewide average for each respective criterion, except the population to primary care physician ratio, as its upper limit. The Level 2 upper limit for the primary care physician to population ratio is established by dividing the difference between the Level 4 upper limit for this criterion and the Level 1 upper limit by two. Each observation which is equal to or less than the Level 2 upper limit, but greater than the Level 1 upper limit, will be assigned a numerical value of two.

The Level 1 range shall have an upper limit which is the quotient of the statewide average divided by two. For the ratio of population to primary care physician criterion, the upper limit of Level 1 shall be the ratio 2500:1 as recommended by the American Academy of Family Physicians. Each observation that is equal to or less than the Level 1 upper limit will be assigned a numerical value of one.

The Level 3 range shall have an upper limit that is equal to the sum of the upper limit of the Level 1 range and the upper limit of the Level 2 range. For the ratio of population to primary care physician criterion, the upper limit of level 3 shall be established at 3500:1, the federal standard for designating health manpower shortage areas. Each observation that is equal to or less than the Level 3 upper limit will be assigned a numerical value of three.

The Level 4 range will include any observation greater than the upper limit of Level 3 range. Each observation in the Level 4 range will be assigned a numerical value of four.

The values for each of the ranges of the criteria will be summed for each Virginia city and county. Each Virginia city and county will have an assigned value of five or greater, to a maximum of 20. A statewide average value will be determined by summing the total city and county values and dividing by the number of cities and counties. Any city or county assigned a value that is greater than the statewide average value shall be considered medically underserved.

B. Determining medically underserved areas within cities and counties. Geographic subsections of cities or counties may be designated as medically underserved areas when the entire city or county is not eligible if the subsection has: (i) a population to primary care physician ratio equal to or greater than 3500:1; and (ii) a population whose rate of poverty is greater than the statewide average poverty rate; and (iii) a minimum population of 3,500 persons residing in a contiguous, identifiable, geographic area. The board shall from time to time, on petition of any person, or as a result of its own decision, apply criteria for determining medically underserved subareas of cities and counties. Once determined to be medically underserved, any subarea of a city or county shall appear on the next list of medically underserved areas published by the board. Areas which qualify as medically underserved areas under 12VAC5-540-40 A and that are within Standard Metropolitan Areas as defined by the U.S. Department of Commerce, must also qualify under this section for purposes of placement of health professionals.

History

• Statutory Authority: §§ 32.1-12 and 32.1-122.5 of the Code of Virginia.
• Historical Notes: Derived from VR355-40-500 § 2.2, eff. July 3, 1991; amended, Virginia Register Volume 32, Issue 7, eff. December 30, 2015.

Chapter 542 Rules and Regulations Governing the Virginia Nurse Practitioner/Nurse Midwife Scholarship Program

Part I Definitions

12VAC5-542-10 Definitions

The following words and terms, when used in this chapter, shall have the following meanings unless the context clearly indicates otherwise:

"Board" or "Board of Health" means the State Board of Health.

"Certified" means having passed an examination through a national certifying organization.

"Commissioner" means the State Health Commissioner.

"Interest at the prevailing bank rate for similar amounts of unsecured debt" means the prime lending rate as published in the Wall Street Journal on the last day of the month in which the decision to repay is communicated to the commissioner by the recipient, plus two percentage points.

"Medically underserved area" means a geographic area in Virginia designated by the State Board of Health in accordance with the Rules and Regulations for the Identification of Medically Underserved Areas (12VAC5-540-10 et seq.).

"Nurse midwife" means a registered nurse who has met the additional requirements of education and professional certification to practice as a nurse midwife in the Commonwealth.

"Nurse practitioner" means a registered nurse who has met the additional requirements of education and professional certification to practice as a nurse practitioner in the Commonwealth.

"Practice" means to practice as a nurse practitioner or nurse midwife in a medically underserved area in an employment setting that provides services to persons who are unable to pay for the service and that participates in all government sponsored insurance programs designed to assure access of covered persons to medical care services.

"Recipient" or "scholarship recipient" means an eligible registered nurse who enters into a contract with the commissioner and receives one or more scholarship awards via the Virginia Nurse Practitioner/Nurse Midwife Scholarship Program.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.5 and 32.1-122.6:02 of the Code of Virginia.
• Historical Notes: Derived from VR355-40-700 § 1.1, eff. August 1, 1994.

Part II General Information

12VAC5-542-20 Purpose

This chapter sets forth the criteria for eligibility, circumstances under which awards will be made, and the process for awarding Virginia nurse practitioner/nurse midwife scholarships to students; the general terms and conditions applicable to the obligation of each recipient of a nurse practitioner/nurse midwife scholarship to practice full time as a nurse practitioner/nurse midwife in a medically underserved area of Virginia, as identified by the Board of Health by regulations; and penalties for a recipient's failure to fulfill the practice requirements of the Virginia Nurse Practitioner/Nurse Midwife Scholarship Program.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.5, and 32.1-122.6:02 of the Code of Virginia.
• Historical Notes: Derived from VR355-40-700 § 2.1, eff. August 1, 1994.

12VAC5-542-30 Administration

The Commissioner of Health shall act as fiscal agent for the board in administration of the scholarship program through a Nursing Scholarship Committee. All scholarship awards are made by a Nursing Scholarship Committee, appointed by the State Board of Health. The Nursing Scholarship Committee shall consist of five members or their designees: three faculty members representing nurse practitioner or nurse midwife education programs, one nurse practitioner actively engaged in practice, and one former scholarship recipient (commencing the third year of scholarship availability). Committee appointments shall be for two years and members may not serve more than two consecutive terms.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.5, and 32.1-122.6:02 of the Code of Virginia.
• Historical Notes: Derived from VR355-40-700 § 2.2, eff. August 1, 1994.

12VAC5-542-40 Variance

Any requests for variance from this chapter shall be considered on an individual basis by the board in regular session.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.5, and 32.1-122.6:02 of the Code of Virginia.
• Historical Notes: Derived from VR355-40-700 § 2.3, eff. August 1, 1994.

Part III Scholarship Awards

12VAC5-542-50 Eligible applicants

Any student accepted or enrolled in an accredited nurse practitioner or nurse midwife program shall be eligible for a Virginia Nurse Practitioner/Nurse Midwife Scholarship. Preference for the scholarship award shall be given to: residents of the Commonwealth; minority students; students enrolled in family practice, obstetrics and gynecology, pediatric, adult health and geriatric nurse practitioners programs; and residents of medically underserved areas of Virginia as determined by the Board of Health in accordance with the provisions of 12VAC5-540-10 et seq.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.5, and 32.1-122.6:02 of the Code of Virginia.
• Historical Notes: Derived from VR355-40-700 § 3.1, eff. August 1, 1994.

12VAC5-542-60 Scholarship amount

The amount for Virginia nurse practitioner/nurse midwife scholarships available each year shall be as provided by the Virginia General Assembly in that year's Appropriation Act. Scholarships shall be awarded to the recipients upon or following the recipient's execution of a contract with the commissioner for scholarship repayment.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.5, and 32.1-122.6:02 of the Code of Virginia.
• Historical Notes: Derived from VR355-40-700 § 3.2, eff. August 1, 1994.

12VAC5-542-70 Distribution of scholarships

Annually, by March 1 of each calendar year, the Nursing Scholarship Committee shall inform the nurse practitioner/nurse midwife schools of education of the availability of the nurse practitioner/nurse midwife scholarships and provide the schools with application forms for submission by eligible applicants. Until such time as a fully accredited nurse midwife education program is established at any health service center in Virginia, attendance at an accredited program in a nearby state is acceptable for scholarship eligibility. The Nursing Scholarship Committee shall convene annually for the purpose of reviewing applications and awarding scholarships. Scholarship awards shall be based upon majority vote of the Nursing Scholarship Committee.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.5, and 32.1-122.6:02 of the Code of Virginia.
• Historical Notes: Derived from VR355-40-700 § 3.3, eff. August 1, 1994.

Part IV Contracts

12VAC5-542-80 Contract provisions

Prior to the payment of money to a scholarship awardee, the commissioner shall enter into a contract with the recipient. The contract shall:

1. Provide that the recipient will pursue the nurse practitioner/nurse midwife course of the designated school until graduation and will pursue full-time practice as a nurse practitioner or nurse midwife within two years following completion of training and for a period of years equal to the number of annual scholarships awarded. The area of employment must be on the list of Virginia medically underserved areas approved by the State Board of Health and in an employment setting that provides services to persons who are unable to pay for the service and that participates in all government sponsored insurance programs designed to assure access of covered persons to medical care services on the date of commencement of contract obligation fulfillment.

2. Provide that the recipient will not voluntarily obligate himself for military service prior to completion of the repayment period.

3. Provide for termination of the contract by the recipient while the recipient is enrolled in nurse practitioner or nurse midwife school, upon the recipient's notice and immediate repayment to the Commonwealth of the total amount of the scholarship funds plus interest at the prevailing bank rate for similar amounts of unsecured debt, computed from the date of receipt of funds by the recipient.

4. Provide that if the recipient fails to maintain satisfactory academic progress the recipient may, upon certification by the Nursing Scholarship Committee, be relieved of the contract obligation to engage in full-time nurse practitioner/nurse midwife practice upon repayment to the Commonwealth of the total amount of scholarship funds received plus interest at the prevailing bank rate for similar amounts of unsecured debt, computed from the date of receipt of funds by the recipient.

5. Provide that if the recipient is in default due to death or permanent disability so as not to be able to engage in nurse practitioner/nurse midwife practice, the recipient, or his personal representative, may be relieved of the obligation under the contract to engage in full-time practice upon repayment to the Commonwealth of the total amount of scholarship funds received plus interest at the prevailing bank rate for similar amounts of unsecured debt from the date of receipt of scholarship funds. For recipients completing part of the practice obligation prior to becoming permanently disabled, the total amount of scholarship funds received and owed shall be reduced by the amount of the annual scholarship award multiplied by the number of years practiced. Unusual hardship may be reviewed by the board on a case-by-case basis.

6. Provide that individual cases of extraordinary hardship may be considered by the commissioner for forgiveness of payment or service.

7. Provide that any recipient of a scholarship who defaults by evasion or refusal to fulfill the obligation to practice for a period of years equal to the number of annual scholarships received shall reimburse the Commonwealth three times the total amount of the scholarship funds received plus interest on the tripled obligation amount at the prevailing bank rate of interest for similar amounts of unsecured debt.

8. Provide that for a recipient who fulfills only part of the contractual obligation, the total amount of scholarship funds received and owed shall be reduced by the amount of the annual scholarship, divided into months and multiplied by the number of months practiced in the appropriate area, and the remainder tripled as provided in subdivision 5 of this section.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.5, and 32.1-122.6:02 of the Code of Virginia.
• Historical Notes: Derived from VR355-40-700 § 4.1, eff. August 1, 1994.

Part V Repayment

12VAC5-542-90 Repayment of scholarships

Unless repayment is forgiven as specified in subdivision 6 of 12VAC5-542-80 or by special variance as provided in subdivision 5 of 12VAC5-542-80, all scholarships shall be repaid to the Commonwealth, either by the recipient's practice as a nurse practitioner or nurse midwife or through cash payments as specified in subdivisions 7 and 8 of 12VAC5-542-80.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.5, and 32.1-122.6:02 of the Code of Virginia.
• Historical Notes: Derived from VR355-40-700 § 5.1, eff. August 1, 1994.

12VAC5-542-100 Repayment by practice

It is the intent of the Virginia Nurse Practitioner/Nurse Midwife Scholarship Program that recipients repay their scholarship obligation by practice. Each recipient electing to repay by practice shall notify the commissioner in writing of his proposed practice location not more than 30 days following beginning of employment. Written approval of the practice location will be sent the recipient by the commissioner. A recipient will receive one year of credit toward fulfillment of his scholarship application for each 12 months of full-time (minimum of 40 hours per week) continuous practice. Absences from practice in excess of seven weeks per 12-month practice period for maternity leave, illness, vacation, or any other purpose shall not be credited toward repayment and will extend the recipient's total obligation by the number of weeks of excess absence. Any recipient who partially completes a scholarship obligation will be required to fulfill the remainder of the scholarship obligation by cash repayment in accordance with 12VAC5-542-110. Credit for partial years of service will be applied toward fulfillment of the scholarship obligation.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.5, and 32.1-122.6:02 of the Code of Virginia.
• Historical Notes: Derived from VR355-40-700 § 5.2, eff. August 1, 1994.

12VAC5-542-110 Cash repayment

Cash repayment by recipients who terminate their contracts prior to the completion of training shall be made in accordance with subdivisions 3 and 4 of 12VAC5-542-80 and by recipients who become disabled before fulfilling the practice obligation in accordance with subdivision 5 of 12VAC5-542-80. Cash repayments by recipients who otherwise fail or refuse to fulfill their practice obligation shall be made in accordance with subdivisions 7 and 8 of 12VAC5-542-80.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.5, and 32.1-122.6:02 of the Code of Virginia.
• Historical Notes: Derived from VR355-40-700 § 5.3, eff. August 1, 1994.

12VAC5-542-120 Cash repayment amount

The full amount to be repaid by a recipient who fails or refuses to fulfill the practice obligation shall be determined in the following manner: the annual amount of the scholarship for the year the recipient obtained the scholarship multiplied by three, plus interest (current bank rate of interest on a similar amount of unsecured debt) calculated from the date of receipt of funds by the recipient until the scholarship is fully paid. Repeat the above calculation for each scholarship that the recipient obtained and add the sums of the calculation to determine the total amount due to be repaid to the Commonwealth.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.5, and 32.1-122.6:02 of the Code of Virginia.
• Historical Notes: Derived from VR355-40-700 § 5.4, eff. August 1, 1994.

12VAC5-542-130 Cash repayment schedule

Any scholarship to be repaid in cash payments due to the recipient's failure to enter into an approved practice shall be repaid within 24 months of the date contract obligation should commence. Any scholarship to be repaid in cash payment due after partial repayment by practice shall be paid within 24 months of the recipient's departure from his approved practice. Failure of any recipient to make any payment on his debt of restitution plus interest when it is due shall be cause for the commissioner to refer the debt to the Attorney General of the Commonwealth of Virginia for collection. The recipient shall be responsible for any costs of collection as may be provided in Virginia law.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.5, and 32.1-122.6:02 of the Code of Virginia.
• Historical Notes: Derived from VR355-40-700 § 5.5, eff. August 1, 1994.

Part VI Records and Reporting

12VAC5-542-140 Reporting requirements

Reporting requirements of nurse practitioner/nurse midwife schools and scholarship recipients are as follows:

1. Each nurse practitioner/nurse midwife school shall maintain accurate records of the status of scholarship recipients until the recipients graduate and during any postgraduate year that a scholarship is awarded. The schools shall provide a report listing the academic status of each recipient annually to the Nursing Scholarship Committee.

2. Each scholarship recipient shall, at any time, provide information as requested by the commissioner to verify compliance with the practice requirements of the scholarship contract. The recipient shall report any change of mailing address, change of academic standing, change of intent to fulfill his contractual obligation and any other information which may be relevant to the contract at such time as changes or information may occur. The recipient shall promptly respond with such information as may from time to time be requested by the commissioner.

3. The Nursing Scholarship Committee will report annually to the board the following: number of applicants for scholarships, number of scholarships awarded, number of Virginia residents awarded scholarships, number of minorities and students from medically underserved areas awarded scholarships, total funding awarded, the practice sites of former scholarship recipients, and the number of students making monetary repayment of scholarship with reasons for failure to practice identified.

History

• Statutory Authority: §§ 32.1-12, 32.1-122.5, and 32.1-122.6:02 of the Code of Virginia.
• Historical Notes: Derived from VR355-40-700 § 6.1, eff. August 1, 1994.

Chapter 550 Board of Health Regulations Governing Vital Records

Part I General Information

12VAC5-550-5 Definitions

In addition to the words and terms defined in § 32.1-249 of the Code of Virginia, the following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Board" means the State Board of Health.

"Commissioner" means the State Health Commissioner.

"Department" means Virginia Department of Health.

"Immediate family" means a registrant mother, father (name must be shown on the certification), sibling, current spouse and adult children.

"Informant" means person providing information to complete the filing of a vital record in order to document a vital event.

"Midwife" means a registered nurse who has met the additional requirements of education and examination for licensure as a nurse practitioner in the Commonwealth.

"Primary evidence" means valid first-hand documentation established before the registrant's 18th birthday, such as school admission records, physician's records, immunization records, passport, federal census abstracts, baptismal records and insurance applications.

"Registrant" means the person whose personal information is registered and filed in the systems of vital records.

"Secondary evidence" means valid documentation established after the registrant's eighteenth birthday such as marriage records, child's birth certificate, school records, social security records, driver's records, work permit and employment records. Such evidence must be at least five years old.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

12VAC5-550-10 (Repealed.)

Historical Notes

Derived from VR355-29-100 § 1.1, eff. April 1, 1995; repealed, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

12VAC5-550-20 Purpose of chapter

The board has promulgated this chapter to facilitate the vital record registration activities and health statistical services in a manner to ensure the uniform and efficient administration of the system. Required certificates, reports, and forms shall be prescribed, where feasible, to include data collected nationally for the benefit of all citizens. The protection of individual data from casual perusal is essential to the validity of the program as well as a desirable shield of sensitive personal information while providing health statistics for the protection of society as a whole.

History

• Statutory Authority: § 32.1-273 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 1.2, eff. April 1, 1995.

12VAC5-550-30 Administration of chapter

This chapter is administered by the board, the commissioner, and the State Registrar of Vital Records and Health Statistics.

The State Registrar shall carry out the provisions of Chapter 7 (§ 32.1-249 et seq.) of Title 32.1 of the Code of Virginia and the regulations of the board.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 1.3, eff. April 1, 1995; amended, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

12VAC5-550-40 (Repealed.)

Historical Notes

Derived from VR355-29-100 § 1.4, eff. April 1, 1995; repealed, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

12VAC5-550-50 Application of Administrative Process Act

Except where specifically provided otherwise by statute, the provisions of the Virginia Administrative Process Act, which is codified as Chapter 1.1:1 of Title 9 of the Code of Virginia, shall govern the adoption, amendment, modification, and revision, of this chapter, and the conduct of all proceedings hereunder.

History

• Statutory Authority: § 32.1-273 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 1.6, eff. April 1, 1995.

12VAC5-550-60 Powers and procedures of chapter not exclusive

The board reserves the right to authorize any procedure for the enforcement of this chapter that is not inconsistent with the provisions set forth herein and the provisions of Chapter 7 of Title 32.1 of the Code of Virginia.

History

• Statutory Authority: § 32.1-273 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 1.7, eff. April 1, 1995.

Part II Supplies and Forms

12VAC5-550-70 State Registrar

The State Registrar shall prepare, print, and supply all blanks and forms to be used in registering, recording, and preserving data of vital records and health statistics or in otherwise carrying out the purpose of the statutes governing vital statistics. He shall prepare and issue such detailed instructions concerning use of all forms, approved electronic media and supplies as may be required to secure the uniform observance of the statutes and the maintenance of an adequate system for the collection, registration, and preservation of data of vital records and health statistics throughout the Commonwealth.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 2.1, eff. April 1, 1995; amended, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

12VAC5-550-80 County and city registrars

County and city registrars shall maintain an adequate supply of all forms and blanks as furnished by the State Registrar in order to furnish required forms and blanks to all registrars and reporting sources within their jurisdiction.

History

• Statutory Authority: § 32.1-273 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 2.2, eff. April 1, 1995.

12VAC5-550-90 Use of forms

No forms or electronic media other than those approved and supplied by the State Registrar shall be used for vital event registration. All such forms, records, and reports are property of the Commonwealth of Virginia. As such, they shall be protected from unauthorized use, access, and distribution and shall be surrendered to the State Registrar or his representative upon demand.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 2.3, eff. April 1, 1995; amended, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

Part III Data Required on Vital Statistics Certificates

12VAC5-550-100 Birth certificate items

A. Certificate of Live Birth, Commonwealth of Virginia, for registrations at time of birth, shall contain the following items: child's full name; place of birth; usual residence of mother; sex of child; single or plural birth, and birth order of plural birth; date of birth; full name of father (except when mother is not married to the father); age of father (except when mother is not married to the father); birthplace of father (except when mother is not married to the father); full maiden name of mother; age of mother; birthplace of mother; certification of parent (if available); certification of attendant at the birth, including title, address and date signed; date the certificate was received by the registrar; registrar's signature; registration area and certificate numbers; state birth number; and supplemental confidential data to consist of the following items: medical record and social security numbers of the mother; medical record number of the child; hispanic origin, if any, and race of mother; education of mother; mother transferred prior to delivery; hispanic origin, if any, and race of father (except when mother is not married to the father); social security numbers of the father; education of father (except when mother is not married to the father); pregnancy history of mother, including date of last live birth and date of last other termination of pregnancy; date of last normal menses and physician's or midwife's estimate of gestation; month of pregnancy prenatal care began; source of prenatal care; number of prenatal visits; birthweight of child in grams; mother married to father of child; Apgar score of child at one minute and five minutes; obstetric procedures and method of delivery; newborn conditions and congenital malformations or anomalies of child, if any; infant transferred; medical history for this pregnancy; other history for this pregnancy; events of labor and delivery, and an optional item for the parent to request the State Registrar to report the birth to the Social Security Administration for account number issuance.

B. Delayed Certificate of Birth, Commonwealth of Virginia, for delayed registrations of birth, shall contain the following items: full name at time of birth; sex; place of birth; date of birth; name of father (except when mother was not married to father at the time of birth or during the 10 months next preceding the birth); race of father (except when mother was not married to the father); birthplace of father (except when mother was not married to the father); full maiden name of mother; race of mother; birthplace of mother; certification and signature of applicant; address of applicant; relationship of applicant to registrant; statement and signature of notary public (or other official authorized to administer oaths); description of documentary evidence submitted; certification and authorized signature of the State Registrar; date certificate filed by the State Registrar; and number of certificate.

C. Certificate of Live Home Birth, Commonwealth of Virginia, is required to be registered within 30 days after time of birth and shall be registered with the local health department in which the birth occurred. The local registrar or the deputy registrar shall forward such registration of Live Home Birth filed within 30 days to the State Registrar. The Certificate of Live Home Birth, Commonwealth of Virginia, for registrations at time of birth, shall contain the following items: child's full name; place of birth; usual residence of mother; sex of child; single or plural birth and birth order of plural birth; date of birth; full name of father (except when the mother is not married to the father); age of father (except when the mother is not married to the father); birthplace of father (except when the mother is not married to the father); full maiden name of mother; age of mother; birthplace of mother; certification of parent (if available); certification of attendant at birth, including title, address, and date signed; date the certificate was received by the registrar; registrar's signature; registration area and certificate numbers; state birth number; and supplemental confidential data to consist of the following items: medical record and social security numbers of the mother; hispanic origin, if any, and race of mother; education of mother; mother transferred prior to delivery; hispanic origin, if any, and race of father (except when mother is not married to the father); social security number of the father; education of father (except when mother is not married to the father); pregnancy history of the mother, including date of last live birth and date of last other termination of pregnancy; date of last normal menses and physician's or midwife's estimate of gestation; month of pregnancy prenatal care began; source of prenatal care; number of prenatal visits; birth weight of child in grams; mother married to father of child; Apgar score of child at one minute and five minutes; obstetric procedures and method of delivery; newborn conditions and congenital malformations or anomalies of child, if any, infant transferred; medical history of this pregnancy; other history of this pregnancy; events of labor and delivery and an optional item for the parent to request the State Registrar to report the birth to the Social Security Administration for account number issuance. If the Certificate of Live Home Birth is not filed at the time of birth or within 30 days, supporting documents to establish a registration may be required and shall be as follows:

1. Evidence of pregnancy, such as but not limited to:

a. Prenatal record;

b. A statement from a physician or other health care provider qualified to determine pregnancy;

c. A home visit by a public health nurse or other health care provider; or

d. Other evidence acceptable to the State Registrar.

2. Evidence that the infant was born alive, such as but not limited to:

a. A statement from the physician or other health care provider who saw or examined the infant;

b. An observation of the infant during a home visit by a public health nurse; or

c. Other evidence acceptable to the State Registrar.

3. Evidence of the mother's presence in the Commonwealth of Virginia on the date of the birth, such as but not limited to:

a. If the birth occurred in the mother's residence;

(1) A driver's license or state-issued identification card that includes the mother's current residence on the face of the license/card;

(2) A rent receipt that includes the mother's name and address;

(3) Any type of utility, telephone, or other bill that includes the mother's name and address; or

(4) Other evidence acceptable to the State Registrar.

b. If the birth occurred outside of the mother's place of residence and the mother is a resident of the Commonwealth of Virginia, such evidence shall consist of the following:

(1) An affidavit from the owner, supervisor, manager and tenant of the premises where the birth occurred stating that the mother was present on those premises at the time of the birth;

(2) Evidence of the affiants' residence similar to that required in subdivision 3 of this subsection; and

(3) Evidence of the mother's residence in the Commonwealth of Virginia similar to that required in subdivision 3 a of this subsection.

c. If the mother is not a resident of the Commonwealth of Virginia, evidence that the home birth took place in Virginia must consist of clear and convincing evidence acceptable to the State Registrar, such as affidavits of the persons present at the time of the birth, proof of such affiants' residence as set out in subdivision 3 a of this subsection, ambulance records, police records, or the like.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 3.1, eff. April 1, 1995; amended, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

12VAC5-550-110 Death certificate items

The certificate of death to be used shall be the Certificate of Death, Commonwealth of Virginia, and shall contain the following items: full name of decedent; place of death; usual residence; date of death; sex; hispanic origin, if any, and race; education; date of birth; age; birthplace; citizenship; usual occupation and industry; veteran status; social security number or control number issued by the Department of Motor Vehicles; father's name; mother's maiden name; marital status and name of spouse, if married or widowed; informant's name and relationship to decedent; medical certification of cause of death; autopsy; if female, was there a pregnancy during past three months; and supplementary data concerning death due to external causes; certification of attending physician or medical examiner, including title, address, and date signed; disposition of the body; signature of funeral service licensee; name and address of funeral home; date received by registrar; registrar's signature; registration area and certificate numbers; and state file number.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 3.2, eff. April 1, 1995; amended, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

12VAC5-550-120 Fetal death or induced termination of pregnancy report items

A. The Report of Fetal Death Commonwealth of Virginia, and shall contain the following items for spontaneous fetal deaths: place of occurrence; usual residence of patient (mother); full maiden name of patient; medical record number and social security number of patient; hispanic origin, if any, and race of patient; age of patient; education of patient; sex of fetus; patient married to father; previous deliveries to patient; single or plural delivery and order of plural delivery; date of delivery; date of last normal menses and physician's estimate of gestation; weight of fetus in grams; month of pregnancy care began; number of prenatal visits; when fetus died; congenital malformations, if any; events of labor and delivery; medical history for this pregnancy; other history for this pregnancy; obstetric procedures and method of delivery; autopsy; medical certification of cause of spontaneous fetal death; signature of attending physician or medical examiner including title, address and date signed; method of disposal of fetus; signature and address of funeral service licensee or hospital representative; date received by registrar; registrar's signature; registration area and report numbers.

B. The Report of Induced Termination of Pregnancy, Commonwealth of Virginia, and shall contain the following items for induced terminations of pregnancy: place of occurrence; usual residence of patient; patient identification number; age of patient; hispanic origin, if any, and race of patient; education of patient; patient married to father; date of pregnancy termination; pregnancy history of patient; date of last normal menses and physician's estimate of gestation; type of termination procedures; pregnancy terminated because of genetic defect; signature, title, and address of person completing this report; registration area and report numbers.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 3.3, eff. April 1, 1995; amended, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

12VAC5-550-125 Certificate of birth resulting in a stillbirth

In accordance with § 32.1-258.1 of the Code of Virginia, a certificate of birth resulting in a stillbirth shall be issued upon request from the parent for a fetal death of 20 weeks or more gestation and payment of the appropriate fee for a vital record. This certificate shall contain the following information; name (optional), mother's maiden name, father's name (if indicated), date of event, and hospital of occurrence. When no report of spontaneous fetal death is available to establish the event, documentation from the following sources is acceptable: physician or licensed nurse midwife who provided care to the mother, documentation from the medical record maintained at the hospital of occurrence, copy of the report of spontaneous fetal death or documentation from funeral service director (if such services were provided).

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

12VAC5-550-130 Marriage return and certificate items

The record of marriage to be used shall be the Marriage Return and Certificate, Commonwealth of Virginia, and shall contain the following items: city or county of the court of issuance; court clerk's number; for the groom: full name, age, date and place of birth, social security number or control number issued by the Department of Motor Vehicles, race, marital status if previously married, number of marriage, education, usual residence, the names of parents; for the bride: full name, maiden name, age, date and place of birth, social security number or control number issued by the Department of Motor Vehicles, race, marital status if previously married, number of marriage, education, usual residence, and names of parents; signature of clerk of court and date of license; date and place of marriage; whether civil or religious ceremony; certification and signature of officiant indicating title, address, and year and court of qualification; date received by clerk of court from officiant; and state file number.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 3.4, eff. April 1, 1995; amended, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

12VAC5-550-140 Report of divorce or annulment items

The report of divorce or annulment to be used shall be the Report of Divorce or Annulment, Commonwealth of Virginia, and shall contain the following items: city or county of court of issuance; for the husband: full name, date and place of birth, social security number or control number issued by the Department of Motor Vehicles, education, number of marriage, usual residence; for the wife: full maiden name, date and place of birth, social security number or control number issued by the Department of Motor Vehicles, education, number of the marriage, usual residence; date and place of marriage; identity of plaintiff and to whom divorce granted; number and custody of children under 18 in this family; date of separation; date of divorce; legal grounds or cause of divorce; signature of attorney or petitioner; certification and signature of clerk of court indicating type of decree; court file number; date final order entered; and state file number.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 3.5, eff. April 1, 1995; amended, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

Part IV Preparation of Certificates

12VAC5-550-150 Requirements for completion

All certificates and records provided for in the statutes governing vital event registration shall be prepared on a typewriter with a black ribbon whenever possible or shall be printed legibly in black ink or written legibly in black unfading ink or entered on electronic media approved by the State Registrar. All signatures required shall be entered in black ink. No certificate shall be considered as complete and correct and acceptable for filing that:

1. Does not supply all items of information called for thereon or satisfactorily account for their omission.

2. Contains alterations or erasures.

3. Does not contain original signatures.

4. Is marked "copy" or "duplicate."

5. Is a carbon copy or photocopy.

6. Is prepared on an improper form.

7. Contains obviously improper or inconsistent data.

8. Contains any data relative to the putative father of a child born out of wedlock without his written consent or unless determined by a court of competent jurisdiction as required by § 32.1-257 of the Code of Virginia.

9. Contains an indefinite cause of death denoting only symptoms of disease or conditions resulting from disease.

10. Is not prepared in conformity with these regulations or instructions issued by the State Registrar.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 4.01, eff. April 1, 1995; amended, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

Part V Registration Districts

12VAC5-550-160 Geographical areas

For vital event registration purposes, the Commonwealth is hereby divided into registration districts as follows: Each independent city and each county shall constitute a registration district, provided that the State Registrar may designate special registration districts within cities and counties where necessary to facilitate registration.

History

• Statutory Authority: § 32.1-273 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 5.1, eff. April 1, 1995.

12VAC5-550-170 Registrars' representatives

Each registrar for an independent city or county may appoint one or more representatives to act for the registrar after regular office hours. Such representatives may issue out-of-state transit permits as specified in Part X of this chapter.

History

• Statutory Authority: § 32.1-273 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 5.2, eff. April 1, 1995.

Part VI Duties of Registrars

12VAC5-550-180 Acceptance of certificates

Each registrar shall examine certificates as they are submitted for registration to determine whether they have been prepared in accordance with the provisions of the statutes, regulations, and instructions. If unsatisfactory, it shall be the duty of the registrar to notify the person responsible for the registration of its defects and to secure a complete and correct registration. Each registrar or his deputy shall note over his signature the date each certificate of birth, death, or report of fetal death was filed with him and shall number consecutively the certificates of birth, death, and fetal death in three separate series beginning with number 1 for the first certificate in each respective series in each calendar year.

History

• Statutory Authority: § 32.1-273 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 6.1, eff. April 1, 1995.

12VAC5-550-190 Local records

On forms furnished by the State Registrar or on electronic media approved by the State Registrar, each registrar shall record the following information from the original records before forwarding such original records to the State Registrar:

1. For birth records: the full name of the child, sex and race of child, date of birth, place of birth, names of parents, residence of parents, date filed, and local certificate number.

2. For death records: the full name of the decedent, race and sex of decedent, date of death and place of death, date filed, and local certificate number.

3. For spontaneous fetal death records: surname of family, race and sex of fetus, date and place of delivery, date filed, and local report number.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 6.2, eff. April 1, 1995; amended, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

12VAC5-550-200 Reporting periods

A. Special registrars shall, upon receiving all information on the properly completed forms, forward them to the State Registrar on the fifth day of the month. If no birth, death, or fetal death was registered in any month, that fact shall be reported on the fifth day of the following month on a form provided for that purpose.

B. City and county registrars shall transmit weekly to the State Registrar all complete original certificates filed with them or received by them from special registrars during the period preceding such dates. Each shipment of certificates sent by special registrars and by city and county registrars shall be accompanied by a transmittal form provided for that purpose.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 6.3, eff. April 1, 1995; amended, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

12VAC5-550-210 Promotion of registration

Each registrar is to familiarize himself with the statutes, regulations, and instructions so that he may promote and stimulate complete and accurate registration. Lists of hospitals, physicians, medical examiners, funeral service licensee, and midwives should be maintained where necessary for reference purposes.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 6.4, eff. April 1, 1995; amended, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

Part VII Foundling Registration

12VAC5-550-220 Procedure

Whoever assumes custody of a living infant of unknown parentage shall on a blank certificate of live birth report the required facts. The certificate shall be plainly marked "foundling registration" in the top margin and data required will be determined by approximation. Parentage data shall be left blank, and the certification of the informant shall be signed by the custodian indicating title, if any. The item "Certification of the attendant," shall be signed by the physician who examines the foundling child. On the reverse of the form shall be listed the name and address of the persons or institution with whom such child has been placed for care and the date and place the child was found.

History

• Statutory Authority: § 32.1-273 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 7.1, eff. April 1, 1995.

Part VIII Delayed Birth Registration

12VAC5-550-230 Late registration and delayed registration defined

A. The registration of a nonrecorded birth after the statutory time prescribed for filing but within one year from the date of birth shall be a "late birth registration." As such, its filing shall be subject to the requirements of 12VAC5-550-250 but shall not be considered a "delayed registration." The registration of a nonrecorded birth after one year from the date of birth shall be a "delayed birth registration."

B. For those births occurring more than one year but less than seven years prior to the date of filing, the birth registrations shall be prepared and filed on the certificate of live birth form in use at the time of birth and shall be plainly marked in the upper margin "delayed registration." Such certificates shall be subject to the requirements of 12VAC5-550-250 and not subject to 12VAC5-550-260.

C. The registration of a nonrecorded birth seven or more years after the date of birth shall be a "delayed birth registration" and shall be registered by the State Registrar on special forms provided for such purposes and shall be subject to the requirements of 12VAC5-550-260.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 8.1, eff. April 1, 1995; amended, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

12VAC5-550-240 Who may file a late or delayed birth certificate and conditions

A. A person born in the Commonwealth of Virginia whose birth is not recorded, or his parent or guardian, legal representative, or an older person having knowledge of the facts of birth, may file a certificate of birth after the time prescribed for filing subject to the procedures and requirements established by these regulations and instructions issued by the State Registrar.

B. No delayed Certificate of Birth shall be registered for a deceased person.

C. Application for delayed certificates that have not been completed within one year from the date of application may be dismissed at the discretion of the State Registrar. Upon dismissal, the State Registrar shall so advise the applicant and all documents submitted in support of such registration shall be returned to the applicant.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 8.2, eff. April 1, 1995; amended, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

12VAC5-550-250 Procedures and requirements for late birth registration and delayed birth registration within seven years of date of birth

A. Late birth registrations and delayed birth registrations filed within seven years of the date of birth shall be prepared and filed on the certificate of live birth form in use at the time of birth. To be acceptable for filing, the certificate must be signed by the physician or other person who attended the birth; or if the birth occurred in a hospital, the hospital administrator, or his designated representative, may sign the certificate; or if the physician or other person who attended the birth is not available, and the birth did not occur in a hospital, the certificate may be signed by one of the parents, provided that a notarized statement is attached to the certificate outlining the reason why the certificate cannot be signed by the attendant.

B. The State Registrar or the city or county registrar may require the presentation of additional evidence in support of the facts of birth or an explanation for the delay in filing in any case where there appears to him reason to question the adequacy of the registration. Home birth records shall follow procedures in 12VAC5-550-100 C.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 8.3, eff. April 1, 1995; amended, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

12VAC5-550-260 Procedure and requirements for delayed birth registration seven or more years after date of birth

A. Application for a delayed birth registration after seven years have elapsed since the date of birth shall be made to the State Registrar and shall be filed according to instructions issued by the State Registrar.

B. If a prior birth certificate is located for the registrant, a delayed birth certificate shall not be filed. The final acceptance of a delayed birth certificate for filing shall remain in a pending status until evidence is submitted in support thereof satisfactory to the State Registrar as outlined in subsection E of this section, or until one year from the date of application, in which event the application shall lapse.

C. The following facts concerning the person whose birth is to be registered must be established:

1. The full name of the person at the time of birth, except that the delayed certificate may reflect a name established by adoption or legitimation when such evidence is submitted;

2. The date and place of birth; and

3. The names of the parents, except that if the mother of the child was not married to the father of the child at the time of birth, or during the 10 months preceding such birth, the name of the father shall not be entered on the delayed certificate unless the child has been adopted or legitimated, or parentage has been determined by a court of competent jurisdiction pursuant to § 32.1-257 of the Code of Virginia, or both natural parents present a sworn acknowledgement of paternity.

D. Delayed birth certificates shall be prepared on forms supplied by the State Registrar. Each such delayed certificate shall be signed and sworn to before an official authorized to administer oaths by the person whose birth is to be registered if such person is available and is competent to sign and swear to the accuracy of the facts stated therein; if not, the application shall be signed and sworn to by one of the parents, guardian, legal representative, or by an older person having knowledge of the facts of birth.

E. The birth facts entered on the delayed certificate shall be supported by at least three pieces of documentary evidence; except that:

1. If one of the documents was established before the registrant's seventh birthday, only two such documents shall be required.

2. If the person whose birth is being registered is 15 years of age or under, only two such documents shall be required.

F. All documents used shall be primary evidence, such as school admission records, physician's records, insurance applications, baptismal records, federal census abstracts, immunization records, or passports. Only one affidavit of personal knowledge shall be used as an additional supporting document.

G. Facts of parentage need only be supported by one such document described in subsection F of this section.

H. Documents shall be in the form of the original or certified or true copies of the original.

I. All documents, except the affidavit of personal knowledge, shall be returned to the applicant after review.

J. Whether delayed certificates and documentary evidence submitted conform with this chapter and are acceptable for filing shall be determined by the State Registrar. If, in his judgment, an applicant does not submit the documentation required in support of the facts of birth or if there appears reason to question the delayed registration, the delayed birth certificate shall not be accepted and the applicant shall be advised of its deficiencies.

1. If a delayed birth certificate is acceptable for filing, the State Registrar or his designated representative shall abstract on the delayed birth certificate form a description of each document submitted in support of the delayed registration, including the kind and title of the document; the name and relationship of the affiant if the document is an affidavit of personal knowledge; the date the document was originally established; and

2. The State Registrar or his designated representative shall then enter the date of filing of the delayed registration, and by his signature thereto shall certify:

a. That no prior birth certificate is on file for the person whose birth is to be registered.

b. That the documentary evidence submitted to establish the facts of birth has been reviewed and is in conformity with the stated facts.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 8.4, eff. April 1, 1995; amended, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

12VAC5-550-270 Cancellation records

When the State Registrar shall be satisfied that a late or a delayed birth certificate was obtained through fraud or misrepresentation, he shall give to the person named in the certificate a notice in writing of his intention to cancel said certificate. The notice shall give such person an opportunity to appear to show cause why the certificate should not be cancelled. The notice may be served on such person or in the case of a minor or incompetent to his parent or guardian by forwarding the notice by certified mail to his last known address on file in the Division of Vital Records and Health Statistics. Any appeal shall be governed by the provisions of the Virginia Administrative Process Act pursuant to Title 9, Chapter 1.1:1 of the Code of Virginia.

History

• Statutory Authority: § 32.1-273 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 8.5, eff. April 1, 1995.

Part IX New Birth Certificates after Adoption, Legitimation, Acknowledgement of Paternity, or Court Determination of Paternity

12VAC5-550-280 Adoptions

New birth certificates after adoption, legitimation, acknowledgment of paternity, or court determination of paternity shall be established under the following conditions:

1. A new certificate of birth may be prepared by the State Registrar for a child born in Virginia and subsequently adopted through the courts of Virginia, the several states of the United States, or in a foreign country. An adoption report or certified copy of an adoption decree must be in the possession of the State Registrar together with a request that a new certificate be prepared.

2. A certificate of birth may be prepared by the State Registrar for a child born in a foreign country and subsequently adopted through a court in Virginia. An adoption report must be in the possession of the State Registrar together with a request that a Virginia registration of the birth be prepared. Such certificates shall not confer citizenship upon the child or the adoptive parents.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 9.1, eff. April 1, 1995; amended, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

12VAC5-550-290 Legitimation

If the biological parents of a child shall marry after the birth of a child, a new certificate of birth may be prepared by the State Registrar for a child born in Virginia provided that the name of another man is not shown as the father on the original certificate. An affidavit of paternity, executed subsequent to the birth of the child, by both biological parents and a certified copy of the parents' marriage record must be in the possession of the State Registrar together with a request that a new certificate be prepared. If another man is so listed, a new certificate may be prepared only if a determination of paternity shall be ordered by a court of competent jurisdiction or pursuant to § 20-49.8 of the Code of Virginia. If the mother was married at the time of the child's birth or in the 10 months next preceding, the State Registrar will not accept the acknowledgment of paternity form. A new certificate may be prepared only if a determination of paternity shall be ordered by a court of competent jurisdiction or pursuant to § 20-49.8 of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 9.2, eff. April 1, 1995; amended, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

12VAC5-550-300 Acknowledgement of paternity

A new certificate of birth may be prepared by the State Registrar for a child born out of wedlock in this Commonwealth upon receipt of a sworn acknowledgement of paternity, executed subsequent to the birth of the child, signed by both parents and a written request by both parents that the child's surname be changed or not be changed on the certificate to that of the father. If the mother was married at time of the child's birth or in the 10 months next preceding or if another man is shown as the father of the child on the original certificate, a new certificate may be prepared only when a determination of paternity is made by a court of competent jurisdiction or pursuant to § 20-49.8 of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 9.3, eff. April 1, 1995; amended, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

12VAC5-550-310 Court determination of paternity

A. If no appeal has been taken from the final order and the time allowed to perfect an appeal has expired, a new certificate of birth may be prepared by the State Registrar for a child born in this Commonwealth upon receipt of a certified copy of a court determination of paternity.

B. A new certificate of birth may be prepared by the State Registrar for a child born in the Commonwealth upon receipt of the certified copies of a document signed by a man indicating his consent to submit to scientifically reliable genetic tests, including blood tests, to determine paternity and the genetic test results affirming at least a 98% probability of paternity from an ABBA-approved laboratory, together with a request from the biological mother, biological father or person having legal custody of the child that such new certificate be prepared. Changing the child's surname to the biological father's surname requires the signatures of both parents or (i) the father in the case of death or incapacity of the mother or (ii) the mother in the case of the death or incapacity of the father.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 9.4, eff. April 1, 1995; amended, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

12VAC5-550-320 Change of sex

Except as provided in subdivision 3 of 12VAC5-550-450, upon presentation of acceptable evidence (preoperative diagnosis, postoperative diagnosis and description of procedure) and a notarized affidavit from the physician performing the surgery, a new certificate of birth may be prepared by the State Registrar for a person born in this Commonwealth whose sex has been changed by surgical gender reassignment procedure. A certified copy of the court order changing the name of the registrant as well as designating the sex of the registrant must be in the possession of the State Registrar together with a request that a new certificate be prepared.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 9.5, eff. April 1, 1995; amended, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

12VAC5-550-330 New certificate

The new certificate of birth prepared after adopting, legitimation, court determination of paternity, or acknowledgement of paternity shall be on the form in use at the time of birth; however, a same-sex adoption new certificate of birth shall be on the form that shows the parents' designation as "Name of Parent," and shall include the following items and such other information necessary to complete the certificate:

1. The name of the child;

2. The date and place of birth as transcribed from the original certificate;

3. The names and personal particulars of the adoptive parents or of the natural parents, whichever is appropriate;

4. The name of the attendant, printed or typed;

5. The birth number assigned to the original birth certificate;

6. The original filing date. The information necessary to locate the existing certificate and to complete the new certificate shall be submitted on forms prescribed by the State Registrar.

History

• Statutory Authority: § 32.1-12 and Chapter 7 (§ 32.1-249 et seq.) of Title 32.1 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 9.6, eff. April 1, 1995; amended, Virginia Register Volume 26, Issue 1, eff. October 14, 2009.

12VAC5-550-340 Sealed files

After preparation of the new certificate, the existing certificate and the evidence upon which the new certificate was based are to be placed in a special file. Such file shall not be subject to inspection except upon order of a circuit court of this Commonwealth or by the State Registrar for purposes of properly administering the system of vital records and health statistics.

History

• Statutory Authority: § 32.1-273 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 9.7, eff. April 1, 1995.

Part X Procedures for Filing Death Certificates

12VAC5-550-350 A proper and complete medical certification of cause of death defined

A complete and properly executed medical certification of cause of death shall mean the entry by a physician or medical examiner of a definite medical diagnosis of the underlying cause of death and related conditions following the instructions indicated on the death certificate. This may be variously:

1. Supported by clinical findings of the physician who attended the deceased for the illness or condition that resulted in death;

2. Supported by tentative clinical findings that may or may not be supported by the gross findings of an autopsy; or

3. Supported by autopsy findings where necessary to establish a definite medical diagnosis of cause of death.

In cases where an autopsy is to be performed, the physician or medical examiner shall not defer the entry of the cause of death pending a full report of microscopic and toxicological studies. In any case where the autopsy findings significantly change the medical diagnosis of cause of death, a supplemental report of the cause of death shall be made by the physician or medical examiner to the registrar as soon as the findings are available. (As examples: If it is clear that a patient dies of "cancer of the stomach," report the cause while a determination of the histological type is being carried out. Similarly, if it is clear that a death is from "influenza," do not delay the medical certification while a laboratory test is being carried out to determine the strain).

History

• Statutory Authority: § 32.1-273 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 10.1, eff. April 1, 1995.

12VAC5-550-360 Responsibility of the attending physician

When a patient dies, the physician in charge of the patient's care for the illness or condition shall be responsible for executing and signing the medical certification of cause of death as follows:

1. The physician shall execute and sign the medical certification of cause of death on the death certificate form prescribed by the State Registrar.

2. In an case where an autopsy is scheduled and the physician wishes to await its gross finding to confirm a tentative clinical finding, he shall give the funeral service licensee notice that he attended the patient and when he expects to have the medical data necessary for the certification of cause of death. If the provisions of 12VAC5-550-350 cannot be adhered to, he shall indicate that the cause is pending and sign the certification. Immediately after the medical data necessary for determining the cause of death have been made known, the physician shall, over his signature, forward the cause of death to the registrar.

3. If the physician is unable to establish the cause of death or if a death is within the jurisdiction of the medical examiner, he shall immediately report the case to the local medical examiner and advise the funeral service licensee of this fact. If the medical examiner does not assume jurisdiction, the physician shall sign the medical certification noting special circumstances and exception.

4. An associate physician who relieves the attending physician while he is on vacation or otherwise temporarily unavailable may certify to the cause of death in any case where he has access to the medical history of the case, provided that he views the deceased at or after death occurs and that death is from natural causes. In all other cases in which a physician is unavailable, the funeral service licensee shall contact the medical examiner.

5. When the attending physician shall have given the person in charge of an institution authorization in writing, the person in charge of such institution, or his designated representative, may prepare the medical certification of cause of death in cases where all pertinent aspects of the medical history are a part of the official medical records and the death is due to natural causes. In such instances, the signature shall be that of a physician.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 10.2, eff. April 1, 1995; amended, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

12VAC5-550-370 Responsibility of the medical examiner

When a medical examiner assumes jurisdiction in a death or when a medically unattended death occurs without medical attendance a known medical history or information, the medical examiner shall be responsible for executing and signing the medical certification of cause of death as follows:

1. The medical examiner shall, at the time of releasing a body to a funeral service licensee or person who first assumes custody of a dead body, or as soon as practicable thereafter, execute and sign the medical certification of cause of death on the death certificate form prescribed by the State Registrar.

2. In any case where an autopsy is scheduled and the medical examiner wishes to await its gross findings to confirm a tentative clinical finding, he shall give the funeral service licensee notice as to when he expects to have the medical data necessary for the certification of cause of death. If the provisions of 12VAC5-550-350 cannot be adhered to, he shall indicate that the cause is pending and sign the certification. Immediately after the medical data necessary for determining the cause of death have been made known, the medical examiner shall, over his signature, forward the cause of death to the registrar.

3. In any case where a death has been referred to the medical examiner because a physician in attendance is deceased or physically incapacitated and there was no associate physician, the medical examiner shall prepare and sign the medical certification of cause of death.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 10.3, eff. April 1, 1995; amended, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

12VAC5-550-380 Responsibility of the hospital or institution

When a patient shall die in a hospital or institution, and the death is not under the jurisdiction of the medical examiner, the person in charge of such institution, or his designated representative, shall where feasible and where the cause of death is known, aid in the preparation of the death certificate as follows:

1. Place the full name of the deceased on the death certificate form and obtain from the attending physician the medical certification of cause of death.

2. If authorized in writing by the attending physician, the person in charge, or his designated representative, may prepare the medical certification of cause of death in cases where all pertinent aspects of the medical history are a part of the official hospital records and the death is due to natural causes. The signature shall be that of a physician.

3. Present the partially completed death certificate identified by the name and the complete medical certification to the funeral service licensee.

4. In a case of long-term residence by a patient in a state institution, a death certificate including personal particulars of the deceased may be prepared for presentation to the funeral service licensee.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 10.4, eff. April 1, 1995; amended, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

12VAC5-550-390 Responsibility of the funeral service licensee

Each funeral service licensee who has been authorized to take custody of a dead human body shall exercise the following responsibilities with respect to the preparation and filing of the death certificate:

1. When he arrives to take custody of the body, he shall first ascertain whether an attending physician or local medical examiner has established the cause of death as follows:

a. The funeral service licensee shall obtain the medical certification of cause of death from the physician if the death is from natural causes. An associate physician or person in charge of an institution may prepare the medical certification as outlined in 12VAC5-550-360.

b. If a physician attended the deceased but did not complete the medical certification of cause of death, the funeral service licensee shall immediately contact such physician in person or by telephone to be certain that he was the attending physician and to ascertain whether the physician is to assume responsibility for the medical certification or to refer the case to the medical examiner.

c. When a medical examiner assumes jurisdiction in a death, or when a physician in attendance is incapacitated, the funeral service licensee shall obtain the signed medical certification of cause of death from the medical examiner as required by subdivision 3 of 12VAC5-550-370.

2. The personal history of the deceased and the facts of the death shall be obtained from the best source possible. This source may be variously: a member of the immediate family of the deceased who possesses the necessary information; a hospital records custodian whose records contain the necessary information; or the local medical examiner having jurisdiction over a case. The name of the informant, his address and relationship to the decedent shall be entered on the death certificate. The facts required as to the manner and place of disposal of the body or its removal from the Commonwealth shall be entered over the signature of the funeral service licensee. He shall personally sign the certificate and print or type the name of his firm.

3. Except as outlined in 12VAC5-550-410, a satisfactory death certificate shall be filed with the city, county, or special registrar in the city or county where death occurred, or a dead body is found, prior to final disposal of the body or its removal from the Commonwealth, and within three days. In cases where a completed medical certification is not available when the funeral service licensee takes possession of a body, he shall not move the body from the place of death until so authorized by the local medical examiner or until the attending physician has advised him that death is from natural causes and the physician is able to prepare the medical certification of cause of death. In every case, the removal of a dead human body from the city or county of death is unlawful unless notice is given to the city, county, or special registrar by telephone or in person. Such notice shall consist of the name of the deceased, date and place of death, and the name of the attending physician or of the medical examiner, as the case may be, and, if the body is to be removed, the destination within the Commonwealth. Such notification shall be made during the next available business hours of the registrar following the time of death. After business hours, in independent cities and in designated counties, such notification shall be made immediately on assumption of custody of the deceased to the registrar's representative.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 10.5, eff. April 1, 1995; amended, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

12VAC5-550-400 Out-of-state transit permits

A. The body of any person whose death occurs in Virginia or whose body shall be found dead therein shall not be removed from the Commonwealth unless an out-of-state transit permit on a form prescribed by the State Registrar has been issued by the city, county, or special registrar of the city or county where the death occurred or the body was found except as outlined in 12VAC5-550-410.

B. No out-of-state transit permit shall be issued until a proper certificate of death is filed except as outlined in 12VAC5-550-410.

C. A certificate of death shall be considered to be properly filed:

1. When all items thereon have been answered in the manner prescribed by the State Registrar; and

2. When the certificate has been presented for filing with the city, county, or special registrar of the city or county where the death occurred or the body was found, or, in emergency cases, with the city or county registrar of the area to which removal was made within the Commonwealth.

History

• Statutory Authority: § 32.1-273 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 10.6, eff. April 1, 1995.

12VAC5-550-410 Emergency cases: Filing of death certificates elsewhere

A. Under the conditions of § 32.1-266 of the Code of Virginia, the following situations are declared to be proper reasons for emergency extensions of time periods for filing a completed death certificate:

1. A completed or pending medical certification is unavailable.

2. Personal data concerning the deceased is temporarily unavailable.

3. The body must be moved immediately out of the Commonwealth.

B. If one or more of the above situations exists and the conditions of subdivision 3 of 12VAC5-550-390 have been complied with by the funeral service licensee when the body is to be moved, any authorized registrar, or registrar's representative, may issue an out-of-state transit permit. Such permit shall be issued upon application by a funeral service licensee and the presentation by the funeral service licensee, over his signature only, of a death certificate form complete in as many known details as possible.

C. The incomplete death certificate form originally furnished to the registrar as outlined in subsection B of this section is to be placed by the funeral service licensee with a completed death certificate as soon as the missing data become known or the medical certification is obtained, or within 10 days, whichever occurs first.

D. Under emergency provisions and the conditions of subdivision 1 c of 12VAC12-550-390, the death certificate may be filed with a registrar other than the registrar at the place of death. When a registrar of an area other than the place of death receives a completed death certificate, he shall not sign nor number the certificate, but shall make a notation in the left-hand margin indicating his name and whether or not an out-of-state permit has been issued. The registrar receiving the death certificate shall immediately forward the death certificate to the city or county registrar at the place of death.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 10.7, eff. April 1, 1995; amended, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

12VAC5-550-420 Forwarding "pending cause" death certificates

A death certificate received by a city or county registrar which contains a signed medical certification of cause of death, but the cause is not complete by reason of a pending inquest, investigation, or autopsy should be sent to the State Registrar on the regular reporting date with completed records. If the cause of death is completed by the presentation of a second and complete certificate before the original certificate is sent to the State Registrar, the original incomplete certificate should be marked "VOID." The completed death certificate should be processed as a current certificate and should be forwarded to the State Registrar. If the cause of death is completed by a properly signed query form or other statement, the cause of death information may be added to the incomplete death certificate by the State Registrar.

History

• Statutory Authority: § 32.1-273 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 10.8, eff. April 1, 1995.

12VAC5-550-430 Disinterment permits

A. Unless so ordered by a court of competent jurisdiction, a body shall not be disinterred for removal or transportation until an application for disinterment has been submitted to the city or county registrar or to the State Registrar.

B. The city or county registrar at the place from which disinterment is to be made shall issue a disinterment permit in triplicate. One copy shall be retained by the funeral service licensee to whom issued, one copy filed with the sexton or person in charge of the cemetery in which disinterment is to be made, and one copy to be used during transportation and filed with the sexton or person in charge of the cemetery of reinterment. The State Registrar may issue a letter of authorization in lieu of individual permits when numbers of bodies are to be moved in one operation from the same place of disinterment to the same place of reinterment.

C. A disinterment permit shall not be required if a body is to be disinterred and reinterred in the same cemetery; however, the sexton or other person in charge of the cemetery shall establish a record relative to the facts of disinterment and reinterment within the cemetery.

D. A body kept in a receiving vault shall not be regarded as a disinterred body until after expiration of 30 days.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 10.9, eff. April 1, 1995; amended, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

Part XI Correction and Amendment

12VAC5-550-440 Applications for correction

A. After 30 days from the date of filing, no change or alteration in any birth or death certificate on file with the State Registrar or on file in any city or county of this Commonwealth shall be made except upon application to the State Registrar.

1. To change or alter a birth certificate, such application shall be made by the reporting source, one of the parents, guardian, or legal representative of the child, or, if the person whose certificate is involved is 18 years of age or over, by the person himself.

2. To change or alter a death certificate, such application shall be made by the surviving spouse or the next of kin of the deceased, attending funeral service licensee, or other reporting source, such as hospital medical records.

3. Changes or alterations of the medical certification of cause of death may be requested only by the attending physician or by the medical examiner.

B. Within 30 days from the date of filing, missing data or corrected information may be entered on a birth or death certificate by the State Registrar or by the city or county registrar when the original record is in his possession.

1. Applications for changes or alterations may be made by persons outlined in subdivision A 1 or A 2 of this section.

2. Missing or corrected data may be obtained at the initiative of the city or county registrar by personal call, telephone, or query form from the reporting source responsible for filing the birth or death certificate. Data so obtained by the registrar shall not be deemed an amendment.

C. Marriage and divorce or annulment records on file with the State Registrar may be amended only by notification from the clerk of court in which the original record is filed. Such notification to the State Registrar shall indicate what items have been amended on the original record and shall indicate that the State Registrar's copy should be amended accordingly. Evidence required for amending marriage and divorce or annulment records shall be determined by the court in which the original record is filed.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 11.1, eff. April 1, 1995; amended, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

12VAC5-550-450 Evidence required for corrections or amendments

Every application for a correction or amendment of a birth or death certificate shall be accompanied by appropriate documentary evidence as follows:

1. Except as provided in subdivisions 2 and 3 of this section, name changes, other than minor corrections in spelling involving the given names or surname of a registrant, or the given names or surnames of the parents or of a spouse as listed on a certificate, shall require that a certified or attested copy of a court order changing the name be obtained.

a. In cases where the mother's married surname is listed instead of her maiden name, a correction can be made administratively with a correction affidavit and copy of her birth record.

b. In cases where the given name shown on a birth certificate was not used or known to the registrant and this fact can be proven by the registrant, the birth certificate can be amended administratively with primary evidence showing the name at birth and a correction affidavit.

2. Within one year of birth, the given names listed on a birth certificate may be changed by the affidavit of:

a. Both parents;

b. The mother in the case of a child born out of wedlock;

c. The father in the case of the death or incapacity of the mother;

d. The mother in the case of the death or incapacity of the father; or

e. The guardian or agency having legal custody of the registrant.

3. In cases of hermaphroditism or pseudo-hermaphroditism, given names of a registrant may be changed on a birth certificate by affidavit of the parents or guardian as listed in subdivision 2 of this section, or by affidavit of the registrant if 18 years of age or older. Additionally, a statement from a physician must be submitted which certified the birth record of the registrant contains an incorrect designation of sex because of congenital hermaphroditism, pseudo-hermaphroditism, or ambiguous genitalia which has since been medically clarified.

4. Except as otherwise provided in the Code of Virginia or this chapter, after one year from the date of birth, any change of name shall be made only by court order, and any second change of name within one year shall be made only by court order.

5. Within seven years after birth, given names may be added to a birth certificate where such information has been left blank by use of an affidavit only prepared by the parent, guardian, or legal representative of the child.

6. If the date of birth on a birth certificate is to be changed more than one year, a certified copy of a court order changing the date of birth shall be submitted. Evidence to be supplied to the court in support of such change should include a federal census transcript from the Bureau of the Census.

7. If the date of birth on a birth certificate is to be changed to one year or less from the date of birth, a federal census transcript from the Bureau of the Census shall be required as documentary evidence.

8. If a federal census transcript cannot be obtained, an affidavit shall be obtained which sets forth: the identity of the incorrect record, the incorrect data as it is listed, the correct data as it should be listed, and the documentary evidence supporting the facts. In addition to the affidavit, a document or certified or true copy of such document must be obtained which was written before the registrants' eighth birth date and will establish the identity of the certificate to be altered or corrected and will support the true and correct facts. Any item of a vital record which has been previously corrected may only be changed again by court order.

9. All documents, except the affidavit, shall be returned to the applicant after review.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 11.2, eff. April 1, 1995; amended, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

12VAC5-550-460 Methods of correcting or altering certificates

A. A new name authorized by court order shall be recorded by drawing a single line through the name appearing on the certificate and inserting above it or to the side of it the new name. In addition, there shall be inserted on the certificate a statement that the name was changed by court order and the date and place of such order. The word "Amended" shall be written in the top margin of the certificate. Certificates on which given names are added within seven years after birth or on which given names have been changed at any time pursuant to subdivision 3 of 12VAC5-550-450 shall not be considered as amended.

B. In all other cases, corrections or alterations shall be made by drawing a single line through the incorrect item, if listed, and by inserting the correct or missing data immediately above it or to the side of it, or by completing the blank item, as the case may be. In addition, there shall be inserted on the certificate a statement identifying the affidavit and documentary evidence used as proof of the correct facts and the date the correction was made. If three months have elapsed from the date of filing, the word "Amended" shall be written in the top margin of the certificate unless otherwise stated in this chapter.

History

• Statutory Authority: § 32.1-273 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 11.3, eff. April 1, 1995.

Part XII Inspection of Records and Disclosure of Information

12VAC5-550-470 Individual requests

A. Upon request, the State Registrar or the city or county registrar shall disclose data or issue certified copies of birth or death records or information when satisfied that the applicant therefor has a direct and tangible interest in the content of the record and that the information contained therein is necessary for the determination or protection of personal or property rights.

B. A direct and tangible interest may be evidenced by requests from the registrant, members of his immediate family, his guardian, or their respective legal representatives in the case of birth records. Such direct and tangible interest may be evidenced by requests from surviving relatives or their legal representatives in the case of death records.

C. For the purposes of securing information or obtaining certified copies of birth records, the term "legal representative" shall include a registrant's attorney; a person with power of attorney for affairs of registrant; an attending physician; or a federal, state or local governmental agency acting in behalf of the registrant or his family.

D. For the purposes of obtaining information of certified copies of death certificates, the term "legal representative" shall include the registrant's funeral service licensee; attorney; person with power of attorney for the affairs of the registrant; insurance company insuring the registrant; a federal, state or local governmental agency acting in behalf of the registrant or his family; a court appointed guardian; or a court appointed administrator.

E. A direct and tangible interest shall not be evidenced by the biological parents of an adopted child; nor by commercial firms, agencies, nonprofit or religious organizations requesting listings of names or addresses.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 12.1, eff. April 1, 1995; amended, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

12VAC5-550-480 Research requests

The State Registrar or the city or county registrar may permit use of data from vital records for bona fide research purposes subject to reasonable conditions the State Registrar may impose to ensure that the use of the data is limited to such research purposes.

History

• Statutory Authority: § 32.1-273 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 12.2, eff. April 1, 1995.

12VAC5-550-490 Official requests

The State Registrar or the city or county registrar may disclose data from vital records to federal, state, county, or municipal agencies of government which request such data in the conduct of their official duties; except that records governed by §§ 32.1-261 and 32.1-274 D and E of the Code of Virginia, may be made available only by the State Registrar for official purposes to federal, state, county, or municipal agencies charged by law with the duty of detecting or prosecuting crime, preserving the internal security of the United States, or for the determination of citizenship.

History

• Statutory Authority: § 32.1-273 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 12.3, eff. April 1, 1995.

12VAC5-550-500 Application for records

The State Registrar or the city or county registrar may require written applications for data; the identification of an applicant; or a sworn statement, when it shall seem necessary to establish an applicant's right to information from vital records.

History

• Statutory Authority: § 32.1-273 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 12.4, eff. April 1, 1995.

Part XIII Certifications of Data; Fees

12VAC5-550-510 Certified copies; how prepared

A. Under the provision of § 32.1-272 of the Code of Virginia and Part XII (12VAC5-550-470 et seq.) of this chapter, certifications of vital records may be prepared and issued by the State Registrar and, where applicable, by the city or county registrar.

B. Certifications may be made by photostat or other reproduction process, typewriter, or electronic print except that medical and health data on the birth certificate shall not be so certified.

C. The statement to appear on each certification of a vital record is to read as follows:

"This is to certify that this is a true and correct reproduction or abstract of the official record filed with the...................Department of Health,......................, Virginia.

Date issued...................

.................................... Registrar"

The registrar will enter the appropriate city or county name in the spaces provided, date and sign the certification, and enter his official title.

D. The seal of the issuing office is to be impressed on the certification.

E. Short form certifications of birth records that make no reference to parentage may be issued by the State Registrar.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 13.1, eff. April 1, 1995; amended, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

12VAC5-550-520 Fees

A. The fee to be charged by the State Registrar or by the city or county registrar shall be $10 for each full certification or short form certification of a vital record, or for a search of the files or records when no copy is made.

B. When documents are amended or delayed birth registration is requested, the requester shall be charged an administrative fee of $10.

History

• Statutory Authority: §§ 32.1-12 and 32.1-250 of the Code of Virginia.
• Historical Notes: Derived from VR355-29-100 § 13.2, eff. April 1, 1995; amended, Virginia Register Volume 19, Issue 26, eff. October 8, 2003.

Chapter 570 Commonwealth of Virginia Sanitary Regulations for Marinas and Boat Moorings

Article 1 Definitions

12VAC5-570-10 Definitions

Article 1 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Board" means the State Board of Health.

"Boat" means any vessel or other watercraft, privately owned or owned by the Commonwealth or any political subdivision thereof, whether moved by oars, paddles, sails, or other power mechanism, inboard or outboard, or any other vessel or structure floating on water in the Commonwealth of Virginia, whether or not capable of self-locomotion, including but not limited to cruisers, cabin cruisers, runabouts, houseboats and barges. Excluded from this definition are commercial, passenger and cargo carrying vessels subject to the Quarantine Regulation of the United States Public Health Service adopted pursuant to Title 42 of the United States Code and ships or vessels of the U.S. Government and boats which are tenders to larger boats moored or stored at the same facility.

"Boating access facility" means any installation operating under public or private ownership that provides a boat launching ramp and has 50 or more parking spaces for boat trailers.

"Certificate" or "certificate to operate" means a written approval from the commissioner or his designated representative indicating that plans for sewerage facilities, sewerage system, and treatment works meet or satisfy the minimum requirements of this chapter and § 32.1-246 of the Code of Virginia.

"Commissioner" means the State Health Commissioner.

"Department" means the Virginia Department of Health.

"Division" means the Division of Onsite Sewage and Water Services, Environmental Engineering, and Marina Programs, Office of Environmental Health Services of the department or its administrative successor.

"Dry storage" means boat storage, including boatels, valet storage, pigeon hole storage, stackominiums, or where boats rest on racks or trailers located on land, whether covered or uncovered, at a marina or other places where boats are moored.

"Expanded" means any change to a regulated facility that results in an increase in sewage volume or strength due to the addition of slips, dry storage spaces, boat trailer parking spaces, or ancillary operations.

"Live-aboard slip" means any slip where a boat is moored and used principally as a residence or a place of business. Charter and commercial fishing boats are not included unless used as a residence.

"Local health department" means the branch of the State Health Department, established in accordance with § 32.1-30 of the Code of Virginia, that has jurisdiction in the city or county where the regulated facility is located.

"Marina" means any installation operating under public or private ownership that provides dockage or moorage for boats, other than paddle or rowboats, and provides through sale, rental, fee, or free basis any equipment, supply, or service including fuel, electricity, or water for the convenience of the public or the lessee, renters, or users of the facilities.

"Marine sanitation device" means any equipment, piping, holding tanks, and appurtenances onboard a boat designed to receive, retain, treat, or discharge sewage.

"No Discharge Zone" means an area where a state has received an affirmative determination from the U.S. Environmental Protection Agency that there are adequate facilities for the removal of sewage from vessels (holding tank pump-out facilities) in accordance with § 312(f)(3) of the Clean Water Act (33 USC § 1251 et seq.) and where federal approval has been received allowing a complete prohibition of all treated or untreated discharges of sewage from all vessels.

"Office" means the Office of Environmental Health Services.

"Other places where boats are moored" means any installation operating under public or private ownership that provides dockage or moorage for boats, other than paddle or rowboats, either on a free, rental, or fee basis or for the convenience of the boater.

"Owner" means the Commonwealth or any of its political subdivisions and any public or private institution, corporation, association, firm, or company organized or existing under the laws of this or any other state, or any person or group of persons acting individually or as a group who owns or proposes to own a marina, other places where boats are moored, or boating access facility.

"Pump-out facility" means any device, equipment, or method for removing sewage from a marine sanitation device and conveying such sewage to a sewerage system or treatment works including any portable, movable, or permanent holding tanks.

"Sewerage facility" means bathrooms, toilets, closets and other enclosures, including portable toilets, where commodes, water closets, lavatories, showers, urinals, sinks, or other such plumbing fixtures are installed.

"Sewage" means water-carried and non-water-carried human excrement, kitchen, laundry, shower, bath, or lavatory waste, separately or together with such underground, surface, storm, and other water and liquid industrial wastes as may be present from residences, buildings, vehicles, boats, industrial establishments, or other places.

"Sewage dump station" means a facility specifically designed to receive waste from portable sewage containers carried on boats and to convey such sewage to a sewerage system or a treatment works.

"Sewerage system" means pipelines or conduits, pump stations and force mains, and all other construction, devices, and appliances used for the collection and conveyance of sewage to a treatment works or point of ultimate disposal.

"Slip" means a berth or space where a boat may be secured to a fixed or floating structure, including a dock, finger pier, boat lift, or mooring buoy.

"Treatment works" means any device or system used in the storage, treatment, disposal, or reclamation of sewage or combinations of sewage and industrial wastes, including but not limited to pumping, power and other equipment and appurtenances, septic tanks, and any works, including land, that are or will be (i) an integral part of the treatment process or (ii) used for ultimate disposal of residues or effluents resulting from such treatment.

"VMRC" means the Virginia Marine Resources Commission.

History

• Statutory Authority: § 32.1-246 of the Code of Virginia.
• Historical Notes: Derived from VR355-17-01 § 1.1, eff. September 1, 1987; amended, Virginia Register Volume 6, Issue 24, eff. October 1, 1990; Volume 32, Issue 6, eff. December 16, 2015.

Article 2 General Information

12VAC5-570-20 (Repealed.)

Article 2 General Information

History

• Historical Notes: Derived from VR355-17-01 § 1.2, eff. September 1, 1987; amended, Virginia Register Volume 6, Issue 24, eff. October 1, 1990; repealed, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-570-30 Purpose

The board has promulgated this chapter to:

1. Protect public health and water quality by ensuring that adequate sewerage facilities, pump-out facilities, sewage dump stations, and sewerage systems are provided at all marinas, other places where boats are moored, and boating access facilities.

2. Establish minimum requirements as to the adequacy of sewerage facilities and sewerage systems at all marinas, other places where boats are moored, and boating access facilities.

3. Protect public health and the environment by ensuring that all sewage generated from all regulated facilities is conveyed to an approved sewerage system or treatment works.

4. Guide the commissioner or his designee in his determination of the adequacy of the sewerage systems and sewerage facilities serving all marinas, other places where boats are moored, and boating access facilities.

5. Guide the commissioner or his designee in his evaluation of plans and other data and in the issuance of a certificate as to the adequacy of sewerage facilities and sewerage systems.

History

• Statutory Authority: § 32.1-246 of the Code of Virginia.
• Historical Notes: Derived from VR355-17-01 § 1.3, eff. September 1, 1987; amended, Virginia Register Volume 6, Issue 24, eff. October 1, 1990; Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-570-40 Administration

A. The commissioner is the chief executive officer of the Virginia Department of Health. The commissioner has the authority to act for the board when it is not in session. The commissioner may delegate his powers under this chapter with the exception of his power to issue variances under 12VAC5-570-90.

B. The division is designated as the primary reviewing agent of the commissioner for the purpose of administering this chapter. Upon receipt of the application from the local health department, the division examines and grants or denies the application for sewerage facilities to serve marinas, other places where boats are moored, and boating access facilities. The division issues all certificates attesting to the adequacy of the sewerage facilities and notifies the VMRC when a certificate is issued or denied.

C. The local health department shall be responsible for processing all applications submitted by owners and for inspecting sites and facilities for compliance with this chapter.

History

• Statutory Authority: § 32.1-246 of the Code of Virginia.
• Historical Notes: Derived from VR355-17-01 § 1.4, eff. September 1, 1987; amended, Virginia Register Volume 6, Issue 24, eff. October 1, 1990; Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-570-50 Applicability

A. Marinas, other places where boats are moored, and boating access facilities in operation prior to the effective date of this chapter shall be subject to the regulations in effect at the time the marina, other places where boats are moored, or boating access facility was permitted unless such marina, other places where boats are moored, or boating access facility is expanded after December 16, 2015.

B. This chapter shall apply to all marinas, other places where boats are moored, and boating access facilities placed into operation on or after December 16, 2015.

C. All sewerage facilities and sewerage systems shall conform to the requirements of this chapter when the marina, other places where boats are moored, or boating access facility that is served by the sewerage facilities and sewerage systems is expanded.

D. This chapter shall apply to sewerage facilities and sewerage systems (i) serving marinas, other places where boats are moored, or boating access facilities and (ii) located on property owned by the marina, other places where boats are moored, or boating access facility. Sewerage systems or treatment works installed or proposed to be installed on property owned by someone other than the marina, other places where boats are moored, or boating access facility owner are regulated by Chapter 6 (§ 32.1-163 et seq.) of Title 32.1 of the Code of Virginia or Title 62.1 of the Code of Virginia, as applicable.

History

• Statutory Authority: § 32.1-246 of the Code of Virginia.
• Historical Notes: Derived from VR355-17-01 § 1.5, eff. September 1, 1987; amended, Virginia Register Volume 6, Issue 24, eff. October 1, 1990; Volume 32, Issue 6, eff. December 16, 2015.

Article 3 Procedure

12VAC5-570-60 Permits and certificate

Article 3 Procedure

No owner shall construct a marina, other places where boats are moored, or a boating access facility unless he has obtained a construction permit in accordance with this chapter. No owner shall operate a marina, other places where boats are moored, or a boating access facility until the local health department has inspected and approved construction and has issued a certificate to operate. Owners shall obtain a permit from the VMRC to operate a marina, other places where boats are moored, or a boating access facility when so required by § 62.1-44.15:5.01 of the Code of Virginia. Where state-owned bottom lands are involved, the owner shall submita preliminary design and receive approval by the division prior to construction and the issuance of a certificate to operate.

History

• Statutory Authority: § 32.1-246 of the Code of Virginia.
• Historical Notes: Derived from VR355-17-01 § 1.6, eff. September 1, 1987; amended, Virginia Register Volume 6, Issue 24, eff. October 1, 1990; Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-570-70 Application for construction permit

A. Any owner, or his duly authorized representative, shall apply for a construction permit by submitting an application to the local health department in the jurisdiction where the proposed marina, other places where boats are moored, or boating access facility is to be located. The application shall be made on a form approved by the division. The application shall consist of the following:

1. Essential data to determine the sewerage facilities and sewerage system necessary to serve the proposed installation.

2. Maps, plans, and specifications of the sewerage facilities and sewerage system describing the type of facilities that will be provided and how the facilities will provide for the safe and sanitary disposal of all sewage generated at the facility. The preliminary design plans shall establish the location of the sewerage facilities and sewerage system in relation to other facilities they are intended to serve.

3. A description of the proposed or existing offsite sewerage system or treatment works used for the ultimate treatment and disposal of sewage. The applicant shall apply for and obtain approval of new offsite sewerage systems or treatment works and demonstrate that the existing sewerage systems or treatment works are approved and in accordance with this chapter.

4. Any other data as may be pertinent to show the adequacy of the sewerage facilities and sewerage system to be provided.

B. An application pursuant to this section shall contain sufficient detail and clarity necessary to demonstrate that the sewerage facility and sewerage system meet all the applicable requirements of this chapter.

C. The department shall issue a permit to construct the proposed marina, other place where boats are moored, or boating access facility after review of a complete application that demonstrates compliance with the requirements of this chapter and § 32.1-246 of the Code of Virginia.

History

• Statutory Authority: § 32.1-246 of the Code of Virginia.
• Historical Notes: Derived from VR355-17-01 § 1.7, eff. September 1, 1987; amended, Virginia Register Volume 6, Issue 24, eff. October 1, 1990; Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-570-80 Certificate to operate

A. Upon completion of construction of the sewerage facilities, sewerage systems, and treatment works at marinas, other places where boats are moored, or boating access facilities, the owner or his duly authorized representative shall notify the local health department so that it may inspect the construction. When the division, in consultation with the local health department, has determined that construction is in compliance with the approved plan, it shall issue a certificate to operate to the owner of the marina, other place where boats are moored, or boating access facility. The certificate to operate shall remain valid in accordance with this section.

B. The owner shall post the certificate to operate in a place where it is readily observable by members of the public who transact business with the facility.

C. All marinas, other places where boats are moored, and boating access facilities shall be subject to a five-year, renewable certificate to operate. The owner of the marina, other place where boats are moored, and boating access facility shall request a new certificate to operate at least 90 days prior to the expiration date of the existing certificate to operate. The division shall issue the new certificate to operate provided the sewerage facilities, sewerage system, and treatment works meet or satisfy the minimum requirements of this chapter and § 32.1-246 of the Code of Virginia.

D. If the commissioner grants a variance, or the division approves any exception to this chapter, then the certificate to operate shall contain that information. The owner of the marina, other place where boats are moored, or boating access facility shall follow any condition or requirement listed on the certificate to operate.

E. As a condition of the certificate to operate, owners of marinas, other places where boats are moored, or boating access facilities shall allow the department to perform one or more inspections per year of the sewerage facilities, sewerage systems, and treatment works to ensure compliance with this chapter and § 32.1-246 of the Code of Virginia. The division may revoke the certificate to operate pursuant to 12VAC5-570-100.

History

• Statutory Authority: § 32.1-246 of the Code of Virginia.
• Historical Notes: Derived from VR355-17-01 § 1.8, eff. September 1, 1987; amended, Virginia Register Volume 6, Issue 24, eff. October 1, 1990; Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-570-90 Variances

A. The commissioner may grant a variance to any requirement of this chapter if, after investigation, the commissioner determines that the hardship imposed upon the owner or the public by compliance with this chapter outweighs the benefits that the chapter confers and that granting a variance will not result in a potential or actual public health hazard.

B. A variance is a conditional waiver of a specific regulation that is granted to an owner of a marina, other places where boats are moored, or a boating access facility. Variances are not transferrable between owners, and any variance shall be attached to the certificate of the marina, other places where boats are moored, or boating access facility to which it was granted. The variance is a condition of the certificate, which is revoked if the certificate is revoked.

C. Any owner of a marina, other places where boats are moored, or a boating access facility may apply in writing for a variance. This application shall be submitted to the local health department in the jurisdiction in which the marina, other places where boats are moored, or boating access facility is located. This application shall include:

1. A citation referencing the specific requirements of this chapter from which a variance is requested and a statement describing the hardships imposed by the specific requirements of this chapter;

2. A statement of reasons why the public health and environment would not be detrimentally affected if a variance is granted and a list of suggested measures that would be implemented to prevent any potential detrimental impacts;

3. Facts supporting the need and justification for the variance;

4. The nature and duration of the variance request;

5. Other information, if any, believed by the applicant to be pertinent; and

6. Such other information as the division, local health department, or the commissioner may require.

D. If the commissioner denies any request for a variance, such denial shall be in writing and shall state the reasons for the denial.

History

• Statutory Authority: § 32.1-246 of the Code of Virginia.
• Historical Notes: Derived from VR355-17-01 § 1.9, eff. September 1, 1987; amended, Virginia Register Volume 6, Issue 24, eff. October 1, 1990; Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-570-100 Revocation of a certificate

Either by emergency order under the authority of § 32.1-13 of the Code of Virginia or following an opportunity for an informal fact-finding proceeding as provided by § 2.2-4019 of the Code of Virginia, the commissioner or his designee may revoke a certificate for failure to construct and operate the sewerage facilities and sewerage system in accordance with the conditions of the application and certificate issued or for any violation of this chapter.

History

• Statutory Authority: § 32.1-246 of the Code of Virginia.
• Historical Notes: Derived from VR355-17-01 § 1.10, eff. September 1, 1987; amended, Virginia Register Volume 6, Issue 24, eff. October 1, 1990; Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-570-110 Applicability of the Administrative Process Act

The Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) shall govern the decision of cases under this chapter.

History

• Statutory Authority: § 32.1-246 of the Code of Virginia.
• Historical Notes: Derived from VR355-17-01 § 1.11, eff. September 1, 1987; amended, Virginia Register Volume 6, Issue 24, eff. October 1, 1990; Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-570-120 General

A. All owners of marinas, other places where boats are moored, and boating access facilities shall provide the minimum number of sewerage facilities required by this chapter for their patrons. Owners shall maintain their facilities in a clean and operable condition. Owners shall equip their facilities with toilet tissue, lights where electricity is available, and soap and towels where handwashing facilities are required. Owners shall make their facilities available during normal business hours to patrons and users of these facilities during the boating season for that facility.

B. Marinas located within 1,000 feet of the shore end of the pier that are operated as part of residential developments, overnight lodging facilities, restaurants, or commercial establishments are exempt from providing separate sewerage facilities, as long as the sewerage facilities at the residence, lodging establishment, restaurant, or commercial establishment are made available to all users of the marina. The exemption set forth in this subsection does not apply to:

1. Marinas associated with restaurants or commercial establishments that allow overnight occupancy of boats; and

2. Marinas associated with overnight lodging establishments where overnight occupancy of boats is permitted by persons not registered at the overnight lodging establishment.

C. Other places where boats are moored and boating access facilities are exempt from the requirements of subsection A of this section, provided that the other places where boats are moored or boating access facility:

1. Serves residents of homes (houses, condominiums, apartments, or mobile homes), their bona fide house guests, or registered guests of tourist establishments; and

2. Provides adequate sewerage facilities located within 1,000 feet of the shore end of the pier.

D. In order to qualify for an exemption under subsection B or C of this section, the owner of a marina, other places where boats are moored, or a boating access facility shall provide to the division a signed, notarized statement that all conditions set forth in this section will be complied with by users of the facilities.

History

• Statutory Authority: § 32.1-246 of the Code of Virginia.
• Historical Notes: Derived from VR355-17-01 § 2.1, eff. September 1, 1987; amended, Virginia Register Volume 6, Issue 24, eff. October 1, 1990; Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-570-130 Location

Owners shall conveniently locate their sewerage facilities within 500 feet walking distance from the shore end of any dock the facilities are intended to serve. On a case-by-case basis the division may approve a greater distance if unusual circumstances, such as topography or resource protection areas, prevent compliance with this requirement. The division may require the owner to provide sewerage facilities in more than one location in order to meet the needs of the particular site. In addition, the division may require additional fixtures, beyond the minimum number specified in Table 1 (12VAC5-570-150), if it determines that additional fixtures are necessary to accommodate the site layout and use of the marina, other places where boats are moored, or boating access facility.

History

• Statutory Authority: § 32.1-246 of the Code of Virginia.
• Historical Notes: Derived from VR355-17-01 § 2.2, eff. September 1, 1987; amended, Virginia Register Volume 6, Issue 24, eff. October 1, 1990; Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-570-140 Availability

Owners shall locate the sewerage facilities so that they are available and reasonably accessible to all users. The location and use of all sewerage facilities shall be clearly indicated by appropriate signage.

History

• Statutory Authority: § 32.1-246 of the Code of Virginia.
• Historical Notes: Derived from VR355-17-01 § 2.3, eff. September 1, 1987; amended, Virginia Register Volume 6, Issue 24, eff. October 1, 1990; Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-570-150 Sewerage facilities for marinas

A. The minimum number of sewerage fixtures to be provided at marinas is found in Table 1.

B. Where dry storage space is provided, each dry storage space is equivalent to one-third of a slip. Separate sewerage facilities for male and female employees may be provided, but shall not be counted toward the minimum number of fixtures required to accommodate users of the marina.

| Table 1 | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | Number of Slips | SEWERAGE FIXTURES | | | | | | | | Commodes | Additional Urinal or Commode | Lavatories | Showers | | | | | | Male | Female | Male | Male | Female | Male | Female | | | 1 - 24 | 1 | 0 | 1 | 1 | | | | | 25 - 49 | 1 | 2 | 1 | 2 | 2 | 1 | 1 | | 50 - 99 | 2 | 3 | 1 | 2 | 2 | 1 | 1 | | 100 - 149 | 3 | 4 | 1 | 3 | 3 | 2 | 2 | | 150 - 199 | 3 | 5 | 2 | 4 | 4 | 2 | 2 | | 200 - 249 | 4 | 6 | 2 | 5 | 5 | 3 | 3 |

C. When the number of slips exceeds those prescribed by Table 1, the owner shall provide additional fixtures. The owner shall provide one commode, lavatory, and shower for each gender for each 100 additional slips.

History

• Statutory Authority: § 32.1-246 of the Code of Virginia.
• Historical Notes: Derived from VR355-17-01 § 2.4, eff. September 1, 1987; amended, Virginia Register Volume 6, Issue 24, eff. October 1, 1990; Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-570-160 Sewerage facilities at other places where boats are moored and boating access facilities

A. Sewerage facilities are required at other places where boats are moored and boating access facilities in accordance with this section.

B. Where piped potable water is available, sewerage facilities for other places where boats are moored shall consist of a minimum of one commode, one lavatory, and one shower for each gender, for each 100 slips.

C. Requirements for dry storage are identical to those specified in 12VAC5-570-150 for marinas.

D. Where piped potable water is not available, sewerage facilities for other places where boats are moored may consist of privies.

E. Sewerage facilities at boating access facilities shall consist of at least one privy or portable toilet and shall be sufficient in number to accommodate facility usage.

F. Walking distance to these facilities shall comply with 12VAC5-570-130.

History

• Statutory Authority: § 32.1-246 of the Code of Virginia.
• Historical Notes: Derived from VR355-17-01 § 2.5, eff. September 1, 1987; amended, Virginia Register Volume 6, Issue 24, eff. October 1, 1990; Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-570-170 Sewage treatment

A. Public or municipal sewerage systems and treatment works should be used if there is reasonable access to sewers. When such municipal means of disposal are not available, the owner shall have designed and installed an approved sewerage system or treatment works. An approved sewerage system or treatment works is (i) a system for which a certificate to operate has been issued jointly by the department and the Department of Environmental Quality, (ii) a system approved by the Department of Environmental Quality in accordance with Title 62.1 of the Code of Virginia, or (iii) a system approved by the commissioner in accordance with Title 32.1 of the Code of Virginia.

B. The sewage design flow for each slip shall be 25 gallons per slip per day. Where dry storage is provided, each dry storage space shall be equivalent to one-third of a slip. The sewage design flow for each live-aboard slip shall be 50 gallons per slip per day. When marinas or other places where boats are moored are constructed in conjunction with another structure or facility, the sewage design flows prescribed in this section shall be added to the sewage design flow governing the associated structure or facility.

C. For marinas or other places where boats are moored that have a boating access facility, the design sewage flow shall be increased by 10 gallons per day per boat trailer parking space.

D. The division may approve a reduction in the sewage flow requirements specified in subsection B of this section if the owner provides documented flow data sufficient to justify the reduction.

History

• Statutory Authority: § 32.1-246 of the Code of Virginia.
• Historical Notes: Derived from VR355-17-01 § 2.6, eff. September 1, 1987; amended, Virginia Register Volume 6, Issue 24, eff. October 1, 1990; Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-570-180 Pump-out

A. Owners of other places where boats are moored that allow overnight docking or mooring of boats and owners of all marinas, regardless of size or number of slips, shall provide pump-out facilities for pumping or removing sewage from boats. These pump-out facilities shall include all the equipment, structures, and treatment or disposal facilities necessary to ultimately discharge or dispose of this boat sewage in an efficient and sanitary manner without causing an actual or potential public health hazard. Exempt from this requirement are marinas and other places where boats are moored that do not have live-aboard slips or allow boats with a marine sanitation device to use any of the services provided, except in an emergency. In order to qualify for this exemption, the owner of such marina or other places where boats are moored shall provide the department with a signed, notarized statement indicating that there are no live-aboard slips and that boats with marine sanitation devices shall not be permitted to use the facility except in an emergency.

B. The owner shall make sewage pump-out facilities available to all users of the marina or other places where boats are moored during normal operating hours. The owner shall maintain the pump-out equipment in serviceable condition and shall keep the equipment located in an area convenient for utilization.

C. The owner shall use placards or signs to identify the sewage pump-out location and use restrictions.

D. Marinas and other places where boats are moored that provide fewer than 50 slips may be exempt from the requirement to install pump-out facilities unless such marinas or other places where boats are moored are located in a No Discharge Zone. Such exemption shall be granted by the division whenever alternate pump-out service is provided at a nearby marina or other places where boats are moored as evidenced by an agreement signed and notarized by both parties in accordance with the requirements of this section, and filed with the division. The division shall only approve such alternate pump-out service in accordance with the following criteria:

1. The alternate pump-out service shall not require more than 20 minutes to complete from the time a boater has the boat ready to receive the service and has previously requested to have the marine sanitation device pumped. The pump-out service for holding tanks of 50-gallon capacity or more (sewage holding) may exceed 20 minutes.

2. The alternate pump-out service shall be located within three nautical miles, as measured along the water route, of the exempt facility unless the alternate pump-out service is located along the normal travel route to open water, in which case the exempt facility shall be within five nautical miles of the alternate pump-out service.

3. The alternate pump-out service capacity shall be sufficient to handle the demand for pump-out service that is expected for all of the marinas or other places where boats are moored entering into the agreement referenced in this subsection.

4. The owner of the exempt facility shall post in a conspicuous location appropriate signage that specifies the location of the alternate pump-out service and the associated charge for its use.

5. The terms of the agreement shall provide that:

a. The alternate pump-out service shall be available to all boats moored at each facility and the alternate pump-out facility will furnish pump-out services to boaters referred to it by the exempt facility as specified by this chapter; and

b. The agreement shall be valid for one year and will be automatically renewable on the anniversary date, unless either party gives at least a 60-day termination notice to the other and to the director of the division prior to the renewal date.

6. If a termination notice is issued to an exempt facility in accordance with this subsection, then that facility shall either provide pump-out service or obtain a new written agreement in accordance with this subsection by the effective date of the termination of alternate pump-out service.

E. The purpose of these minimum design criteria is to provide the owner and the department with acceptable methods for pumping, storing, and conveying the contents from marine sanitation devices. A proposed pump-out facility shall meet the following minimum design criteria:

1. Pump equipment may be fixed or portable; however, this equipment shall be clearly identified or placarded by signs or other notices, indicating any fees, restrictions, or other operating instructions, as necessary. A minimum pump capacity of 10 gallons per minute (gpm) is acceptable at the operating head required to transport the flow to the proper collection or treatment location with such residual head as may be required; however, at marinas with 51 or more slips, greater pumping capacity may be required. To prevent clogging, pumps shall be of a macerator type or the pumps shall be able to pass a 2-inch spherical solid. Manually operated pumps are acceptable at marinas and other places where boats are moored that offer fewer than 26 slips. Pump data from the manufacturer shall include:

a. The type of pump (positive displacement, centrifugal, vacuum, macerator, etc.);

b. Pump power source (electric motor, gasoline engine, etc.) and output (HP);

c. Pump capacity, including a performance curve;

d. Pump solids-handling ability; and

e. A schematic showing relevant pump dimensions, such as height, size, and location of suction and discharge openings, etc.

2. A schematic of the proposed facilities shall be provided and include the following minimum information:

a. Mean low water elevation;

b. Suction hose diameter, length, and highest elevation;

c. Pump elevation;

d. Discharge hose/pipe diameters, lengths, and highest elevation;

e. Discharge point elevation;

f. Type of dock (floating or stationary);

g. Greatest elevation of any dock; and

h. Distance between pump-out location and slips.

All elevations shall be measured with respect to mean low water. If the elevation of mean low water is not known, assume it to be zero.

3. This subdivision sets forth the minimum design criteria for fittings and hoses (piping) used in the operation of a pump-out facility:

a. Suction hoses shall meet the following criteria:

(1) A friction nozzle (right angle preferred) or wand-type attachment is to be provided on the end of the suction hose. Adapters shall be provided to fit any discharge connection from 1.25 to 2 inches in diameter.

(2) A check valve shall be provided on the suction hose at the nozzle.

(3) The hose shall be made of flexible, heavy-duty material that will be noncollapsing and nonkinking. The length of this line shall be determined on an individual case basis by the division.

(4) If the suction line is to be installed in such a manner that sewage would discharge from the line when the pump is removed for service, a full port ball valve shall be provided on the pump end of the suction line.

b. Discharge hose and piping shall meet the following criteria:

(1) The discharge hose or piping shall be equipped with watertight, permanent or positive locking type fittings and connections.

(2) Where flexible discharge hose is used, the hose shall be made of heavy-duty material and be nonkinking and noncollapsing.

c. Discharge lines shall meet the following criteria:

(1) A full port ball valve shall be provided on the discharge line at the pump.

(2) Suitable connections on the end of the discharge line shall be provided to prevent it from dislodging during discharge; all nozzles and fittings are to be positive locking, male and female.

(3) The discharge line shall not be subject to freezing or leaking into the water course.

(4) Sewer lines on piers shall be located below water distribution lines. Water and sewer line separation and sewer line and water source separation requirements are set forth in the Waterworks Regulations (12VAC5-590) and the Sewage Handling and Disposal Regulations (12VAC5-610).

(5) The discharge line connection to the pump-out receiving facility shall be fixed in place in such a manner as to prevent it from dislodging during discharge.

d. Pump-out facilities shall include equipment for rinsing holding tanks associated with marine sanitation devices. Where potable water will be used for rinsing the holding tank, a backflow prevention device shall be installed on the water service line. A minimum of a hose bib type vacuum breaker shall be provided.

4. Other devices or methods of removal of contents from marine sanitation devices may be approved by the division on an individual case basis.

History

• Statutory Authority: § 32.1-246 of the Code of Virginia.
• Historical Notes: Derived from VR355-17-01 § 2.7, eff. September 1, 1987; amended, by Virginia Register Volume 6, Issue 24, eff. October 1, 1990; Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-570-190 Sewage dump station

A. All marinas and other places where boats are moored, regardless of size or number of boat moorings, shall have a proper and adequate receiving station for sewage from portable containers used on boats. Exempt from this subsection are marinas or other places where boats are moored that also qualify for the exemption contained in 12VAC5-570-120 B or C provided that the owner of the sewerage facility consents to the dumping of the contents of portable sewage containers into the sewerage facilities.

B. Where a sewage dump station is required, the owner shall install and maintain it in a serviceable and sanitary condition and in compliance with this chapter. The owner shall make the facilities available to users of the marina or other places where boats are moored. The owner shall locate the sewage dump station in an area convenient for use, and the owner shall use placards or signs to identify its location and restrictions.

C. The purpose of the minimum design criteria is to provide the owner and the department with acceptable methods of discharging sewage from portable containers into a sewage holding tank or a sewerage treatment works. The same criteria set forth in 12VAC5-570-200 A for contents from marine sanitation devices shall apply for sewage dump stations. The sewage dump station receiving unit shall be a minimum of 12 inches in diameter and be equipped with a cover that has a lip of sufficient size to prohibit accidental removal. If the unit is designed to drain, the drain shall be a minimum of four inches in diameter and equipped with a fly tight cover.

D. Marinas and other places where boats are moored that have an operational pump-out facility equipped with a device to pump portable sewage containers are exempt from the requirements of subsection C of this section.

History

• Statutory Authority: § 32.1-246 of the Code of Virginia.
• Historical Notes: Derived from VR355-17-01 § 2.8, eff. September 1, 1987; amended, Virginia Register Volume 6, Issue 24, eff. October 1, 1990; Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-570-200 Onshore facilities

A. Contents from marine sanitation devices and portable sewage containers used on boats shall be discharged to:

1. A public sewerage system for conveyance to an approved treatment works as described in 12VAC5-570-170 A;

2. A holding tank whereby sewage may be stored until it is transported in accordance with the Sewage Handling and Disposal Regulations (12VAC5-610) to an approved treatment works as described in 12VAC5-570-170 A; or

3. An approved sewage treatment works as described in 12VAC5-570-170 A.

B. Disposal of sewage waste from a marine sanitation device shall be prohibited at small sewage treatment plants where shock loading may result or disinfectants and odor inhibitors will affect the operation of the treatment facility. Whenever feasible, the collected sewage shall be discharged directly to the sewerage system of a large sewage treatment facility or transported for eventual treatment at a large sewage treatment facility.

C. For discharge to a public sewerage system, the owner of the marina or other places where boats are moored shall submit to the division, in writing:

1. Evidence of consent to the discharge from the owner of the conveyance system;

2. Evidence of consent to discharge from the owner of any conveyance systems located downstream that may be affected; and

3. Evidence of consent to discharge from the owner of the treatment works where the sewage is to be disposed.

The owner shall verify that there are satisfactory provisions for emptying the contents from portable sewage containers in a sanitary manner.

D. If sewage is to be stored by the marina or other places where boats are moored in a holding tank, the holding tank or tanks shall be sized, constructed, and located to meet the following criteria:

1. Sewage holding tanks shall be sized in accordance with the requirements of Table 2.

| Table 2: Minimum Holding Tank Volume | | | --- | --- | | Total Number of Slips | Minimum Holding Tank Volume (gallons) | | 1 - 300 | 1000 | | 301 - 450 | 1500 | | 451+ | 2000 |

2. Holding tanks shall be constructed in accordance with the following criteria:

a. The holding tank shall be watertight and not subject to any infiltration or leakage.

b. When holding tanks are made of material other than concrete, the internal surface of the holding tank shall be protected from corrosion. Materials used in the manufacture and installation of holding tanks shall be resistant to deterioration by prolonged or frequent contact with deodorizing chemicals, sewage decomposing chemicals, sewage, freshwater, and saltwater.

c. When holding tanks are made of material other than concrete, the external surface of the holding tank shall be protected from corrosion.

d. The holding tank shall be constructed of materials capable of withstanding the forces exerted on its walls.

e. The holding tank shall be located onshore and fixed in place unless it is part of an approved mobile pump-out unit.

f. Provisions shall be made to the satisfaction of the department to assure that the holding tank can be completely emptied. The tank shall be essentially emptied when pumped out.

g. The holding tank shall be adequately vented. This requirement may be met with screened, elbowed down vents installed at the top of the tank.

h. The inlet/outlet of the holding tank shall be compatible with the proposed method of removal.

i. There shall be provisions for emptying the contents from portable sewage containers in a sanitary manner.

3. The required separation distances between holding tank and various structures and features are contained in Table 4.1 of the Sewage Handling and Disposal Regulations (12VAC5-610-597 D).

4. Any person who removes, or contracts to remove and transport by vehicle, the contents of a holding tank shall have a written sewage handling permit issued by the commissioner in accordance with the Sewage Handling and Disposal Regulations (12VAC5-610).

History

• Statutory Authority: § 32.1-246 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

Chapter 590 Waterworks Regulations

Article 1 Definitions [Repealed]

12VAC5-590-10 Definitions and units of measurement

A. Definitions. As used in this chapter, the following words, terms, and abbreviations shall have meanings respectively set forth unless the context clearly requires a different meaning:

"Action level" or "AL" means the concentration of lead or copper in water specified in 12VAC5-590-385, which determines, in some cases, the treatment requirements contained in 12VAC5-590-405 that an owner is required to complete.

"Administrative Process Act" or "APA" means Chapter 40 (§ 2.2-4000 et seq.) of Title 2.2 of the Code of Virginia. The APA is the basic law conferring authority on agencies either to make regulations or case decisions as well as to standardize court review thereof.

"Air gap separation" means the unobstructed vertical distance through the free atmosphere between the lowest point of the potable water outlet and the flood rim of the receiving vessel.

"ANSI" means the American National Standards Institute.

"Applied water" means water that is ready for filtration.

"ASME" means the American Society of Mechanical Engineers.

"ASSE" means the American Society of Sanitary Engineering.

"ASTM" means the American Society for Testing and Materials.

"Auxiliary water system" means any water supply or system on or available to the premises of the consumer other than the waterworks. These may be polluted or contaminated, objectionable, or of questionable quality and constitute an unapproved water supply or system over which the waterworks owner does not have control.

"AWWA" means the American Water Works Association.

"Backflow" means the undesirable reversal of flow of water or mixtures of water and other liquids, gases, or other substances into a waterworks.

"Backflow elimination method" means the air gap separation or physical disconnection that will eliminate the cross-connection.

"Backflow prevention assembly" means a mechanical unit designed to control various cross-connections and stop the reversal of flow that includes an inlet and outlet shutoff valve and test cocks to facilitate testing of the assembly. Backflow prevention assemblies include the reduced pressure principle backflow prevention assembly, the double check valve assembly, and the pressure vacuum breaker assembly.

"Backflow prevention device" means a mechanical unit designed to control cross-connections and stop the reversal of flow that is not testable because it does not have inlet and outlet shutoff valves or test cocks. A backflow prevention device is not generally designed or constructed to withstand continuous pressure over 12 hours, or to control high hazards. A backflow prevention device generally includes the atmospheric type vacuum breakers and the dual check valve type devices.

"Backpressure backflow" means backflow caused by pressure in the downstream piping that is superior to the supply pressure at the point of consideration.

"Backsiphonage" means backflow caused by a reduction in pressure that causes a partial vacuum, creating a siphon effect.

"Bag filters" means pressure-driven separation devices that remove particulate matter larger than one micrometer using an engineered porous filtration media. Bag filters are typically constructed of a nonrigid, fabric filtration media housed in a pressure vessel in which the direction of flow is from the inside of the bag to outside.

"Bank filtration" means a water treatment process that uses a well to recover surface water that has naturally infiltrated into groundwater through a river bed or bank. Infiltration is typically enhanced by the hydraulic gradient imposed by a nearby pumping water supply or other well.

"Best available technology" or "BAT" means the best practicable technology, treatment techniques, or other means that the department finds, after examination for efficacy under field conditions and not solely under laboratory conditions, that are available (taking cost into consideration).

"Board" means the State Board of Health.

"Boil water advisory" and "boil water notice" mean a statement that informs consumers that drinking water is or may be contaminated and that the water should be boiled before being used for human consumption.

"BSSP" means a bacteriological sample siting plan.

"CAP" means a corrective action plan.

"Cartridge filters" means pressure-driven separation devices that remove particulate matter larger than one micrometer using an engineered porous filtration media. Cartridge filters are typically constructed as rigid or semi-rigid, self-supporting filter elements housed in pressure vessels in which flow is from the outside of the cartridge to the inside.

"Case decision" means an agency determination as defined in § 2.2-4001 of the Code of Virginia.

"CCCP" means a cross-connection control program.

"CCR" means consumer confidence report.

"CDC" means the Centers for Disease Control and Prevention.

"CFE" means the combined filter effluent.

"CFR" means the Code of Federal Regulations.

"Clean compliance history" means a record of no PMCL violations for microbiological contaminants, no monitoring violations under 12VAC5-590-370, and no coliform treatment technique trigger exceedances or treatment technique violations under 12VAC5-590-392.

"Coagulation" means a process using coagulant chemicals and mixing by which colloidal and suspended materials are destabilized and agglomerated into floc.

"Combined distribution system" means the interconnected distribution system consisting of the distribution systems of wholesale waterworks and of the consecutive waterworks that receive finished water.

"Commissioner" means the State Health Commissioner, who is the executive officer of the board.

"Community waterworks" means a waterworks that serves at least 15 service connections used by year-round residents or regularly serves at least 25 year-round residents.

"Compliance cycle" means the nine-year calendar year cycle during which a waterworks shall monitor. Each compliance cycle consists of three three-year compliance periods. The first calendar year cycle began January 1, 1993, and ended December 31, 2001, with subsequent compliance cycles continuing thereafter.

"Compliance period" means a three-year calendar year period within a compliance cycle. Each compliance cycle consists of three three-year compliance periods. The first compliance period began January 1, 1993, and ended December 31, 1995, with subsequent compliance periods continuing thereafter.

"Comprehensive business plan" means a plan detailing the technical, managerial, and financial commitments that the owner will make in order to ensure that the waterworks will have the capability to provide water that complies with this chapter over the long term.

"Confirmation sample" means a sample to be collected by the owner within a specified time after the results of the initial sample are known to have exceeded a specified limit or standard in order to validate the initial result and to determine compliance.

"Confluent growth" means a continuous bacterial growth covering the entire filtration area of a membrane filter or a portion of a membrane filter in which bacterial colonies are not discrete.

"Consecutive waterworks" means a waterworks that receives some or all of its finished water from one or more waterworks. Consecutive waterworks may provide additional treatment to finished water. Delivery may be through a direct connection or through the distribution system of one or more consecutive waterworks.

"Consolidated" means rock made from sedimentary, igneous, or metamorphic materials that have been metamorphosed or cemented together forming strata or bodies of rock.

"Consumer" means any person receiving water for human consumption from a waterworks.

"Consumer's water system" means any water system located on the consumer's premises, supplied by or in any manner connected to a waterworks.

"Containment" means the safeguard against backflow into a waterworks from a consumer's water system by installing an appropriate backflow prevention assembly, backflow prevention device, or backflow elimination method at the service connection or downstream of the service connection but before any unprotected takeoffs.

"Contaminant" means any physical, chemical, biological, or radiological substance or matter in water.

"Contaminant release" means an unplanned or uncontrolled release by a waterworks of a chemical contaminant or petroleum or synthetic oil into the water that is treated by or distributed from the waterworks to customers. "Contaminant release" includes any such release at treatment facilities and raw or finished water pump stations.

"Conventional filtration treatment" means a series of processes, including coagulation, flocculation, sedimentation, and filtration, resulting in substantial particulate removal.

"Corrosion inhibitor" means a substance capable of reducing the corrosivity of water toward metal plumbing materials, especially lead and copper, by forming a protective film on the interior surface of those materials.

"Critical equipment failure or malfunction" means any equipment failure or malfunction that has significant potential for serious adverse effects on human health as a result of short-term exposure or to cause a widespread disruption of water service.

"Cross-connection" means any actual or potential link, connection, or physical arrangement, direct or indirect, between used water, an auxiliary water system, or other source of contamination or pollution to the waterworks through which backflow can occur.

"DBPPs" means disinfection byproduct precursors.

"DBPs" means disinfection byproducts.

"DCLS" means the Virginia Department of General Services, Division of Consolidated Laboratory Services.

"Department" means the Virginia Department of Health.

"DEQ" means the Virginia Department of Environmental Quality.

"Diatomaceous earth filtration" means a process resulting in substantial particulate removal in which (i) a precoat cake of diatomaceous earth filter media is deposited on a support membrane (septum), and (ii) while the water is filtered by passing through the cake on the septum, additional filter media known as body feed is continuously added to the feed water to maintain the permeability of the filter cake.

"Direct filtration" means a series of processes, including coagulation and filtration but excluding sedimentation, resulting in substantial particulate removal.

"Disinfectant" means any chemical and physical agents, including chlorine, chlorine dioxide, chloramines, ozone, and UV light, added to water in any part of the treatment or distribution process for the purpose of killing or inactivating pathogenic organisms.

"Disinfection" means a process that inactivates or destroys pathogenic organisms in water by use of a disinfectant.

"Disinfection profile" means a summary of Giardia lamblia or virus inactivation through the water treatment plant.

"Distribution main" means a water pipeline whose primary purpose is to convey drinking water to service connections.

"Distribution system" means a network of pipelines and appurtenances by which a waterworks delivers drinking water to its consumers.

"DOC" means the dissolved organic carbon in a water sample.

"Double check valve assembly" or "double check detector backflow assembly" means a backflow prevention assembly composed of two single independently acting check valves, including tightly closing shutoff valves located at each end of the assembly and test cocks to facilitate testing of the assembly, used for low hazard situations.

"DPOR" means the Virginia Department of Professional and Occupational Regulation.

"Drawdown" means the difference, measured vertically, between the static water level in the well and the water level during pumping.

"Dual sample set" means a set of two samples collected at the same time and same location, with one sample analyzed for TTHM and the other sample analyzed for HAA5.

"Enhanced coagulation" means the addition of sufficient coagulant for improved removal of disinfection byproduct precursors by conventional filtration treatment.

"Enhanced softening" means the improved removal of disinfection byproduct precursors by precipitative softening.

"Entry point" means the place where water from the source after application of any treatment is delivered to the distribution system. Where two or more sources are combined before distribution, the entry point is the location that is representative of the blended water following all treatment.

"EPA" means the U.S. Environmental Protection Agency.

"Equipment failure" means an unplanned condition when the equipment cannot perform or is unable to perform as designed because of a problem with such equipment. "Equipment failure" does not mean a planned (i) removal from service, (ii) repair, or (iii) maintenance.

"Equipment malfunction" means an unplanned condition during which the equipment cannot perform or is unable to perform as designed due to a problem originating from outside the waterworks rather than a problem associated or originating with the equipment itself, including an issue with third-party provided gas or electric power feeds or a cyberattack.

"Exemption" means allowing a waterworks that satisfies the criteria in 12VAC5-590-150 to deviate from a specific PMCL or treatment technique requirement that is granted to the waterworks for a limited period of time.

"Filter profile" means a graphical representation of individual filter performance, based on continuous turbidity measurements or total particle counts versus time for an entire filter run, from start-up to backwash inclusively, that includes an assessment of filter performance while another filter is being backwashed.

"Filtration" means a process for removing particulate matter from water by passage through porous media.

"Finished water" means water that is introduced into the distribution system of a waterworks and is intended for distribution and consumption without further treatment, except as treatment is necessary to maintain water quality in the distribution system (e.g., booster disinfection).

"Flocculation" means a process to enhance agglomeration or collection of smaller floc particles into larger, more easily settleable particles through gentle stirring by hydraulic or mechanical means.

"Flowing stream" means a course of running water flowing in a definite channel.

"Free available chlorine" means that portion of the total chlorine residual remaining in water at the end of a specified contact period that will react chemically and biologically as hypochlorous acid or hypochlorite ion.

"GAC" means granular activated carbon.

"Gross alpha particle activity" means the total radioactivity due to alpha particle emission as inferred from measurements on a dry sample.

"Gross beta particle activity" means the total radioactivity due to beta particle emission as inferred from measurements on a dry sample.

"Groundwater" means all water obtained from sources not classified as surface water.

"Groundwater system" means any waterworks that uses groundwater as its source of supply; however, a waterworks that combines all its groundwater with surface water or with groundwater under the direct influence of surface water before treatment is not a groundwater system. Groundwater systems include consecutive waterworks that receive potable water from another groundwater source.

"Groundwater under the direct influence of surface water" or "GUDI" means any water beneath the surface of the ground with (i) significant occurrence of insects or other macroorganisms, algae, or large-diameter pathogens such as Giardia lamblia or Cryptosporidium or (ii) significant and relatively rapid shifts in water characteristics such as turbidity, temperature, conductivity, or pH that closely correlate to climatological or surface water conditions. GUDI source determinations shall be made by the department in accordance with 12VAC5-590-430.

"GWMA" means the groundwater management area designation by the State Water Control Board.

"Haloacetic acids (five)" or "HAA5" means the sum of the concentrations of the haloacetic acids, expressed in milligrams per liter (mg/L) as rounded to two significant figures. For the purpose of this chapter the HAA5 shall mean monochloroacetic acid, dichloroacetic acid, trichloroacetic acid, monobromoacetic acid, and dibromoacetic acid.

"Halogen" means one of the chemical elements chlorine, bromine, fluorine, astatine, or iodine.

"Health hazard" means any condition, device, or practice in a waterworks or its operation that creates, or may create, a danger to the health and well-being of the water consumer.

"HPC" means the heterotrophic plate count of a bacterial population.

"Human consumption" means drinking, food preparation, dishwashing, bathing, showering, hand washing, teeth brushing, and maintaining oral hygiene.

"Hypochlorite" means the ionic component from the disassociation of hypochlorous acid that performs the function of disinfection. It is the available active ingredient in liquid hypochlorite disinfectants such as sodium and calcium hypochlorite.

"Initial compliance period" means the compliance period in which chemical and radiological monitoring began, and it is represented by the first full three-year compliance period beginning at least 18 months after rule promulgation. It applies to inorganic, organic, and radionuclide contaminants listed in Tables 340.1, 340.2, and 340.4, respectively.

"Isolation" means the safeguard against backflow into a waterworks from a consumer's water system by installing an appropriate backflow prevention assembly or device or by installing a backflow elimination method at the sources of potential contamination in the consumer's water system. This is also called point-of-use isolation.

"Karst geology" means an area predominantly underlain by limestone, dolomite, or gypsum and characterized by rapid underground drainage. These areas often feature sinkholes, caverns, and sinking or disappearing creeks.

"Lake or reservoir" means a natural or man-made basin or hollow on the Earth's surface in which water collects or is stored that may or may not have a current or single direction of flow.

"Lead free" means the following: (i) when used with respect to solders and flux, refers to solders and flux containing not more than 0.2% lead; and (ii) when used with respect to pipes, pipe fittings, plumbing fittings, and plumbing fixtures, refers to the weighted average of wetted surfaces of pipes, pipe fittings, plumbing fittings, and plumbing fixtures containing not more than 0.25% lead.

"Lead service line" means a pipeline made of lead that connects the distribution main to the building inlet and any lead pigtail, gooseneck, or other fitting that is connected to the lead pipeline.

"Leakage" means the loss of potable water from the distribution system, up to the points of service connections, through breaks or defects in piping and piping appurtenances.

"Legionella" means a genus of bacteria, some species of which cause a type of pneumonia called Legionnaires disease.

"Level 1 assessment" means an evaluation to identify the possible presence of sanitary defects, defects in distribution system coliform monitoring practices, and, when possible, the likely reason that the waterworks triggered the assessment.

"Level 2 assessment" means an evaluation to identify the possible presence of sanitary defects, defects in distribution system coliform monitoring practices, and, when possible, the likely reason that the waterworks triggered the assessment in a more comprehensive investigation than a Level 1 assessment.

"Locational running annual average" or "LRAA" means the average of sample analytical results for samples taken at a particular monitoring location during the previous four calendar quarters.

"Log inactivation" means the inactivation of organisms expressed on a logarithmic scale. For example, a 99.9% inactivation is a 3-log inactivation; whereas a 99.99% inactivation is a 4-log inactivation.

"Log removal" means the removal of organisms expressed on a logarithmic scale. For example, a 99.9% is a 3-log removal; whereas a 99.99% removal is a 4-log removal.

"Maximum contaminant level" or "MCL" means the maximum permissible level of a contaminant in potable water that is delivered to any consumer of a waterworks. MCLs are set as close to the MCLGs as feasible using the BAT. MCLs may be either "primary" (PMCL), meaning based on health considerations, or "secondary" (SMCL), meaning based on aesthetic considerations.

"Maximum contaminant level goal" or "MCLG" means the maximum level of a contaminant in drinking water at which no known or anticipated adverse effect on the health of persons would occur and that allows an adequate margin of safety. Maximum contaminant level goals are nonenforceable health goals.

"Maximum residual disinfectant level" or "MRDL" means a level of a disinfectant added for water treatment that may not be exceeded at the consumer's tap without an unacceptable possibility of adverse health effects.

"Maximum residual disinfectant level goal" or "MRDLG" means the maximum level of a disinfectant added for water treatment at which no known or anticipated adverse effect on the health of persons would occur, and that allows an adequate margin of safety. MRDLGs are nonenforceable health goals and do not reflect the benefit of the addition of the chemical for control of waterborne microbial contaminants.

"Maximum total trihalomethane potential" or "MTP" means the maximum concentration of total trihalomethanes (TTHMs) produced in a given water containing a residual disinfectant after seven days at a temperature of 25°C or above.

"Membrane filtration" means a pressure or vacuum-driven separation process in which particulate matter larger than one micrometer is rejected by an engineered barrier, primarily through a size exclusion mechanism, and that has a measurable removal efficiency of a target organism that can be verified through the application of a direct integrity test. Included in this definition are the common membrane classifications of microfiltration (MF), ultrafiltration (UF), nanofiltration (NF), and reverse osmosis (RO).

"Membrane module" means the smallest component of a membrane unit in which a specific membrane surface area is housed in a device with a filtrate outlet.

"Membrane technology" means a process that uses a permeable membrane to remove ions, molecules, or particles from the process stream, such as MF, UF, NF, RO, and electrodialysis reversal (EDR).

"Membrane unit" means a group of membrane modules that share common valving that allows the unit to be isolated from the rest of the system for the purpose of integrity testing or other maintenance.

"Method detection limit" or "MDL" means the minimum concentration of a substance that can be measured and reported with 99% confidence that the analyte concentration is greater than zero and is determined from analysis of a sample in a given matrix containing the analyte.

"Microfiltration" or "MF" means a pressure-driven membrane technology that separates particles, based on the pore-size rating of the membrane, from a feed stream by using a sieving mechanism. Typically, MF can remove particles down to 0.1 micrometer in size.

"Monthly operating report" or "MOR" means the report submitted by a waterworks to the office at least once each month that describes the waterworks' operational status and compliance with applicable laws, regulations, and policies, as directed by the department.

"Most probable number" or "MPN" means the density or number of organisms per unit volume most likely to be present in a water sample and obtained from method-specific statistical MPN tables.

"MPA" means the microscopic particulate analysis method approved by EPA for use in the determination of whether a groundwater is under the influence of surface water.

"Nanofiltration" or "NF"means a pressure-driven membrane technology designed to remove multivalent ions ("softening") and other constituents based on the pore size, which ranges from one to 10 nanometers. Nanofiltration membranes typically operate under a pressure range of 600 to 1100 psi.

"Noncommunity waterworks" means a waterworks that is not a community waterworks, but operates at least 60 days out of the year.

"Noncritical equipment failure or malfunction" means an equipment failure or malfunction that is not a critical equipment failure or malfunction, regardless of whether such anomaly is noticeable to customers of the waterworks.

"Nonpotable water" means water not classified as pure water.

"Nontransient noncommunity waterworks" or "NTNC" means a waterworks that is not a community waterworks and that regularly serves at least 25 of the same persons over six months out of the year. When used in the context of an NTNC, "regularly serves" means four or more hours per day, for four or more days per week, for 26 or more weeks per year.

"NSF" means NSF International, formerly known as the National Sanitation Foundation. NSF collaborates with ANSI and Canadian authorities on drinking water standards development (NSF/ANSI/CAN).

"Office" means the department's Office of Drinking Water.

"One hundred year flood elevation" or "100-year flood elevation" means flood elevation that has a 1.0% probability of being equaled or exceeded in any given year.

"Operating staff" means individuals employed or appointed by an owner to work at a waterworks. Included in this definition are operators, whether or not the operator's license is appropriate for the classification and category of the waterworks, and unlicensed individuals.

"Operator" means any individual with the requisite skills, employed or appointed by any owner, who is designated by the owner to be the person having full responsibility for the waterworks operations and any subordinate operating staff. The individual may be a supervisor, a shift operator, or a substitute in charge, and have duties including testing or evaluation to control waterworks operations. Not included in this definition are superintendents or directors of public works, city engineers, or other municipal or industrial officials whose duties do not include the actual operation or direct supervision of waterworks.

"Optimal corrosion control treatment" means the corrosion control treatment that minimizes the lead and copper concentrations at consumers' taps while ensuring that the treatment does not cause the waterworks to violate any other section of this chapter.

"Optimum fluoride ion concentration" means the fluoride ion concentration recommended by the U.S. Public Health Service for protection from dental caries.

"Owner" means an individual, group of individuals, partnership, firm, association, institution, corporation, governmental entity, or the federal government that supplies or proposes to supply water to any person within the Commonwealth from or by means of any waterworks.

"PAC" means powdered activated carbon.

"PCBs" means polychlorinated biphenyls.

"PER" means a preliminary engineering report.

"Permit" means an authorization granted by the commissioner to construct or operate a waterworks.

"Permitted capacity" means the limiting hydraulic capability of the waterworks, taking into consideration the source water capacity, treatment facilities, finished water storage, delivery, and distribution system.

"Person" means any individual, corporation, partnership, association, cooperative, limited liability company, trust, joint venture, government, political subdivision, or any other legal or commercial entity and any successor, representative, agent, or instrumentality of those entities.

"pH" means the negative logarithm of the hydrogen ion concentration of an aqueous solution.

"Physical disconnection" means the removal or absence of pipes, fittings, or fixtures that connect a waterworks directly or indirectly to any other water system.

"Picocurie" or "pCi" means that quantity of radioactive material producing 2.22 nuclear transformations per minute.

"PMCL" means the primary maximum contaminant level of a contaminant based on health considerations.

"Point of disinfectant application" means the point where the disinfectant is applied and water downstream of that point is not subject to recontamination by surface runoff.

"Point-of-entry device" or "POE device" means a treatment device applied to the water entering a house or building for the purpose of reducing contaminants in the water distributed throughout the house or building.

"Point-of-use device" or "POU device" means a treatment device applied to a single tap for the purpose of reducing contaminants in the water at that one tap.

"Pollution" means the presence of any foreign substance (chemical, physical, radiological, or biological) in water that tends to degrade its quality so as to constitute an unnecessary risk to human health or impair the usefulness of the water.

"Potable water" means the same as "pure water."

"Practical quantitation level" or "PQL" means the lowest level that can be reliably measured within specified limits of precision and accuracy during routine laboratory conditions.

"Prechlorination" means the application of chlorine to water before filtration.

"Presedimentation" means a preliminary treatment process used to remove gravel, sand, and other particulate material from the source water through settling before the water enters the primary clarification and filtration processes in a water treatment plant.

"Pressure vacuum breaker assembly" means a backflow prevention assembly (i) designed to prevent backsiphonage and used for high hazard or low hazard situations; (ii) composed of an independently operating spring-loaded check valve, an independently operating spring-loaded air-inlet valve, and tightly closing shutoff valves located at each end of the assembly; and (iii) fitted with properly located test cocks to facilitate testing of the assembly.

"Primary disinfection" means disinfection to achieve a desired level of inactivation of targeted pathogenic organisms in water by chemical or physical agents as an integral part of the treatment process.

"Process fluids" means any fluid or solution that may be chemically, biologically, or otherwise contaminated or polluted that would constitute a health, environmental, or system hazard if introduced into the waterworks. This includes (i) polluted or contaminated water; (ii) used waters; (iii) cooling waters; (iv) contaminated natural waters taken from wells, lakes or reservoirs, streams, or irrigation systems; (v) chemicals in solution or suspension; or (vi) oils, gases, acids, alkalis, and other liquid and gaseous fluid used in industrial or other processes.

"Process water" means water used for dissolving dry chemicals; diluting liquid chemicals; and operating chemical feeders, treatment facilities, or equipment.

"Project documents" means the engineer's report, design criteria, preliminary and final plans, specifications, and procurement documents for the construction of new waterworks or modifications to existing waterworks.

"Pure water" means water fit for human consumption that is (i) sanitary and normally free of minerals, organic substances, and toxic agents in excess of reasonable amounts and (ii) adequate in quantity and quality for the minimum health requirements of the persons served.

"QCRV" means the quality control release value used in challenge tests of microfiltration (MF) and ultrafiltration (UF) membrane filters.

"RAA" means running annual average.

"Reduced pressure principle backflow prevention assembly" or "reduced pressure zone backflow prevention assembly" or "RPZ assembly" means an assembly designed to prevent backsiphonage or backpressure backflow and used for high or low hazard situations, composed of two independently operating spring-loaded check valves together with an independent, hydraulically operating pressure differential relief valve located between the two check valves. During normal flow and at the cessation of normal flow, the pressure between these two checks is less than the supply pressure. The assembly includes tightly closing shutoff valves located at each end of the RPZ assembly and is fitted with properly located test cocks to facilitate testing of the assembly.

"REM" means the unit of dose equivalent from ionizing radiation to the total body or any internal organ or organ system. A millirem (mrem) is 1/1000 of an REM.

"Repeat compliance period" means any subsequent compliance period after the initial compliance period.

"Residual disinfectant concentration" means the concentration of disinfectant measured in mg/L in a representative sample of water.

"Reverse osmosis" or "RO" means a membrane technology designed to remove salts, low-molecular weight solutes, and all other constituents up to 0.0001 micron in size by applying a pressure in excess of osmotic pressure to force water through a semi-permeable membrane from a region of high solution concentration to a region of lower solution concentration.

"Sanitary defect" means a defect that could provide a pathway of entry for microbial contamination into the distribution system or that is indicative of a failure or imminent failure in a protective barrier that is already in place.

"Sanitary survey" means an evaluation conducted by the department of a waterworks' water supply, facilities, equipment, operation, maintenance, monitoring records, and overall management to ensure the provision of potable water.

"SDWA" means the Safe Drinking Water Act (42 USC § 300f et seq.) and its amendments.

"Seasonal waterworks" means a noncommunity waterworks that is not operated as a waterworks on a year-round basis, and starts up and shuts down at the beginning and end of each operating season.

"Secondary disinfection" means disinfection by chemical oxidants or equivalent agents applied at the entry point or in the distribution system to provide a residual disinfectant in water to maintain water quality and safeguard against chance contamination from permeation, leaching, intrusion, regrowth, or biofilms.

"Sedimentation" means a process for removal of solids before filtration by gravity or separation.

"Service connection" means the point of delivery of finished water from a waterworks to a consumer's water system, fire protection system, irrigation system, and to all other points where finished water is delivered through the distribution system to a consumer. Generally, the service connection occurs at the water meter, or at the distribution main if no water meter is installed, or in the case of an owner of both the waterworks and the building supplied, the point of entry into the building. Service connections may be permanent, temporary, or emergency.

"Service line" means the pipeline or service pipe between the service connection and the building connection.

"Sewer" means any pipe or conduit used to convey sanitary sewage, stormwater, or industrial waste streams. Combined sewers convey both stormwater and sanitary sewage.

"Significant deficiency" means any defect in a waterworks' design, operation, maintenance, or administration, as well as the failure or malfunction of any waterworks component that may cause or has the potential to cause an unacceptable risk to health or could affect the reliable delivery of potable water to consumers.

"Single-family structure" means, for the purpose of 12VAC5-590-375 B only, a building constructed as a single-family residence that is currently used as either a residence or a place of business.

"Site visit" means a tour of a waterworks by the department or other authorized persons for purposes including assessing and documenting the waterworks' physical condition, operations, and compliance activities.

"Slow sand filtration" means a process involving passage of source water through a bed of sand at low velocity (generally less than 0.4 m/h), resulting in substantial particulate removal by physical and biological mechanisms.

"SMCL" means the secondary maximum contaminant level of a contaminant. SMCLs are based on aesthetic qualities related to the public acceptance of drinking water.

"SOP" means standard operating procedure.

"Source water" means water as it is pumped or otherwise withdrawn from a well, spring, stream, lake or reservoir, or any body of surface water (natural or impounded), and before any treatment.

"Supervisory control and data acquisition" or "SCADA" means a computer-controlled system used by a waterworks to monitor its operations. Typical design features may be specific to individual waterworks and include alarm, response, control, and data acquisition.

"Surface water" means all water open to the atmosphere and subject to surface runoff.

"SUVA" means specific ultraviolet absorption at 254 nanometers (nm), an indicator of the humic content of the water. It is a calculated parameter obtained by dividing a sample's ultraviolet absorption at a wavelength of 254 nm (UV₂₅₄) (in m^-1) by its concentration of DOC (in mg/L).

"Synthetic organic chemical" or "SOC" means a man-made organic compound, generally utilized for agriculture or industrial purposes. Table 340.2 lists SOCs regulated as contaminants.

"System hazard" means a condition posing an actual, or threat of, damage to the physical properties of the waterworks or a consumer's water system.

"TDS" means total dissolved solids.

"TMF" means the technical, managerial, and financial capabilities to operate and maintain a waterworks.

"Too numerous to count" or "TNTC" means that the total number of bacterial colonies exceeds 200 on a 47-mm diameter membrane filter used for coliform detection.

"Total organic carbon" or "TOC" means total organic carbon in milligrams per liter (mg/l) measured using heat, oxygen, ultraviolet irradiation, chemical oxidants, or combinations of these oxidants that convert organic carbon to carbon dioxide, rounded to two significant figures.

"Total trihalomethanes" or "TTHM" means the sum of the concentrations of the trihalomethanes (THMs) expressed in milligrams per liter (mg/L) and rounded to two significant figures. For the purpose of this chapter, TTHM means trichloromethane (chloroform), dibromochloromethane, bromodichloromethane, and tribromomethane (bromoform).

"Transient noncommunity waterworks" or "TNC" means a noncommunity waterworks that is not a nontransient noncommunity waterworks (NTNC). A TNC serves at least 25 persons daily for at least 60 days out of the year.

"Treatment" means any process that changes the chemical, physical, radiological, or bacteriological quality of water.

"Treatment technique" or "TT" means a technology or process demonstrated to the satisfaction of the department to lead to a reduction in the level of a specific contaminant sufficient to comply with this chapter.

"Triggered source water monitoring" means monitoring required of any groundwater system as a result of a total coliform-positive sample in the distribution system.

"Trihalomethane" or "THM" means one of the family of organic compounds, named as derivatives of methane, wherein three of the four hydrogen atoms in methane are each substituted by a halogen atom in the molecular structure.

"Ultrafiltration" or "UF" means a membrane technology designed to remove particles up to 0.01 micron in size.

"Unconsolidated" means loose sediment that has not been compacted, cemented, lithified, or metamorphosed into rock. Sediment may be derived from a sedimentary-type, igneous-type, metamorphic-type rock, which includes clay, silt, sand, gravel, and mixtures of these particle types.

"Uncovered finished water storage facility" means a tank, reservoir, or other facility used to store water that will undergo no further treatment to reduce microbial pathogens (except residual disinfection) and is directly open to the atmosphere.

"Unregulated contaminant" or "UC" means a contaminant for which a monitoring requirement has been established, but for which no MCL or treatment technique requirement has been established.

"USBC" means the Uniform Statewide Building Code (13VAC5-63).

"Used water" means any water supplied by a waterworks to a consumer's water system after the water has passed through the service connection and is no longer under the control of the owner.

"UV" means ultraviolet.

"Variance" means allowing a waterworks that satisfies the criteria in 12VAC5-590-140 to provide drinking water that does not fully comply with this chapter. A PMCL variance is a variance to a primary maximum contaminant level, or a treatment technique requirement. An operational variance is a variance to an operational regulation or a SMCL.

"Virus" means a virus of fecal origin that is infectious to humans by waterborne transmission and must be preemptively inactivated through disinfection before human consumption.

"Volatile organic chemical" or "VOC" means an organic compound generally characterized by its low molecular weight and its tendency to vaporize rapidly at relatively low temperatures and pressures. Table 340.2 lists VOCs regulated as contaminants.

"VOSH" means the Virginia Occupational Safety and Health program.

"Waiver" means permission from the department to deviate from the monitoring and reporting requirements in this chapter for a specific contaminant.

"Waterborne disease outbreak" means the significant occurrence of acute infectious illness, epidemiologically associated with the ingestion of water from a waterworks that is deficient in treatment, as determined by the commissioner or the State Epidemiologist.

"Water supply" means the source of water taken into a waterworks including wells, streams, springs, lakes or reservoirs, and other bodies of surface waters (natural or impounded), and the tributaries of those sources, and all impounded groundwater. The term "water supply" does not include any waters above the point of intake of the waterworks.

"Water treatment plant" means that portion of a waterworks intended specifically for water treatment; "water treatment plant" may include, among other operations, coagulation, sedimentation, filtration, and disinfection.

"Waterworks" means a system that serves piped water for human consumption to at least 15 service connections or 25 or more individuals for at least 60 days out of the year. "Waterworks" includes all structures, equipment, and appurtenances used in the storage, collection, purification, treatment, and distribution of potable water except the piping and fixtures inside the building where such water is delivered.

"Waterworks business operation plan" means the same as "comprehensive business plan."

"Wholesale waterworks" means a waterworks that treats source water as necessary to produce potable water and then delivers some or all of that potable water to another waterworks. Delivery may be through a direct connection or through the distribution system of one or more consecutive waterworks.

B. As used in this chapter, the following units of measurement shall use the abbreviations as shown in this subsection:

C – degrees Celsius

CU – color units

ft² – square feet of area

ft/min – feet per minute

ft/sec – feet per second

gpd – gallons per day

gpd/ft² – gallons per day per square foot

gpm – gallons per minute

gpm/ft – gallons per minute per foot

gpm/ft² – gallons per minute per square foot

in – inches

lb – pounds

lb/day – pounds per day

lb/ft² – pounds per square foot

MFL – million fibers per liter

MGD – million gallons per day

mg/L – milligrams per liter

min – minutes

mJ/cm² – millijoules per square centimeter

mrem – millirem

nm – nanometer (10^-9 meter)

NTU – nephelometric turbidity units

pCi – picocuries

pCi/L – picocuries per liter

ppb – parts per billion, or micrograms per liter (μg/L)

ppm – parts per million, or milligrams per liter (mg/L)

ppq – parts per quadrillion, or pictograms per liter (pq/L)

ppt – parts per trillion, or nanograms per liter (ng/L)

psi – pounds per square inch

psig – pounds per square inch gauge

scfm/ft² – standard cubic feet per minute per square foot

µm – micrometers (10^-6 meter or microns)

µg/L – micrograms per liter

µS/cm – microSiemens per centimeter

W/m² – Watts per square meter

History

• Statutory Authority: §§ 32.1-12, 32.1-170, and 32.1-174.5 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-001.02 § 1.1, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 12, Issue 2, eff. November 15, 1995; Volume 18, Issue 19, eff. July 3, 2002; Volume 19, Issue 17, eff. June 4, 2003; Volume 21, Issue 13, eff. April 6, 2005; Volume 22, Issue 24, eff. September 6, 2006; Volume 25, Issue 5, eff. December 10, 2008; Volume 27, Issue 1, eff. October 13, 2010; Volume 28, Issue 5, eff. December 7, 2011; Volume 28, Issue 19, eff. June 21, 2012; Volume 31, Issue 1, eff. October 10, 2014; Volume 33, Issue 3, eff. November 2, 2016; Volume 37, Issue 20, eff. June 23, 2021; Errata, 37:22 VA.R. 3447 June 21, 2021; amended, Virginia Register Volume 42, Issue 5, eff. November 19, 2025; Volume 43, Issue 1, eff. September 23, 2026.

Article 2 General Information [Repealed]

12VAC5-590-20 (Repealed.)

History

• Historical Notes: Derived from VR355-18-002.01 § 1.3, eff. August 1, 1991; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-30 (Repealed.)

History

• Historical Notes: Derived from VR355-18-002.02 § 1.4, eff. August 1, 1991; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-35 Delegation of authority

The commissioner, or the commissioner's designee, may perform any act of the board provided under this chapter, except as limited by § 32.1-20 of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-40 Administration of this chapter

A. The board is responsible for promulgating, amending, and repealing regulations to ensure a supply of potable water.

B. The commissioner is vested with all the authority of the board when it is not in session, subject to such rules and regulations as may be prescribed by the board.

C. The department is designated as the primary agent of the board for the purpose of administering this chapter. It examines the technical aspects of all applications and plans for waterworks projects before drafting a permit for final approval by the commissioner. It also has primary responsibility for monitoring waterworks operations to ensure that water supplied to consumers is potable water.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-002.03 § 1.5, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 20, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-45 Waterworks Advisory Committee

A. A Waterworks Advisory Committee (WAC) shall be formed by the commissioner to review and make recommendations regarding the regulatory, policy, and legislative aspects of the department's authorities. WAC members shall consist of industry professionals employed outside the department with longstanding expertise or vested interest in waterworks operations and represent a diverse group of stakeholders. Members shall be experts in the fields of water treatment technologies, public health, water quality, economics, environmental science, public utilities, community development, or industry regulations. A minimum of nine persons shall be appointed to the committee by the commissioner.

B. The WAC will convene at least quarterly.

C. WAC meetings will be considered public meetings. Notice of scheduled meetings will be posted on the Virginia Regulatory Town Hall at least three working days before the date of the meeting. Meeting minutes will be posted to the Virginia Regulatory Town Hall within 10 working days after the meeting.

D. Each member of the WAC shall hold office for a term of three years, except that:

1. With approval by the commissioner, members are eligible for reappointment to consecutive terms.

2. Each member of the WAC serves at the pleasure of the commissioner.

E. The commissioner shall appoint the chair of the WAC.

F. The WAC shall have a member of the department serve as secretary.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-50 Application of this chapter to waterworks in operation or planned before June 23, 2021

A. The owner shall comply with Part II (12VAC5-590-340 et seq.) of this chapter unless a variance or exemption is issued by the commissioner.

B. Compliance with design criteria set forth in Part III of this chapter is limited to modifications to existing waterworks and for all construction of new waterworks commenced after June 23, 2021. Portions of waterworks not being modified are not required to comply with the design criteria of Part III (12VAC5-590-640 et seq.). Waterworks construction or modification is deemed to be commenced for purposes of this section upon issuance of the construction permit.

C. Compliance with the requirements set forth in Part III of this chapter including those for materials, construction methods, and disinfection is necessary for all repairs to pipes, tanks, pumps, and appurtenances that are part of a waterworks.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-002.04 § 1.6, eff. August 1, 1991; amended, Virginia Register Volume 12, Issue 2, eff. November 15, 1995; Volume 27, Issue 1, eff. October 13, 2010; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-55 Relationship of this chapter to the Uniform Statewide Building Code

A. This chapter governs waterworks facilities from any source water to all service connections.

B. In accordance with § 36-98 of the Code of Virginia and the USBC, the USBC governs the construction of buildings and structures, including plumbing systems and backflow prevention. The USBC also governs the water service piping from the service connection to a building or structure.

C. Notwithstanding subsections A and B of this section, this chapter shall govern:

1. Water treatment, storage, pumping facilities, and water piping that are part of a waterworks and housed in any building or structure; and

2. Backflow prevention assemblies or elimination methods, or both, installed for containment and located downstream from the service connection, including where located in any building or structure.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

Article 3 Procedures [Repealed]

12VAC5-590-60 (Repealed.)

History

• Historical Notes: Derived from VR355-18-003.01 § 1.7, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-70 Powers and procedures

The board reserves the right to utilize any lawful procedure for the enforcement of this chapter.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-003.02 § 1.8, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-80 (Repealed.)

History

• Historical Notes: Derived from VR355-18-003.03 § 1.9, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-90 [Reserved]. (Reserved)

12VAC5-590-100 Exception; emergency regulations

If the establishment of a regulation is necessary to meet any emergency not provided for by this chapter, the board or commissioner acting on behalf of the board when it is not in session may immediately promulgate and adopt the necessary regulation by complying with the procedures set forth in either § 2.2-4011 or § 32.1-13 of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-003.05 § 1.11, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-110 Enforcement

A. Notice. Whenever the department has reason to believe that a violation of Title 32.1 of the Code of Virginia or of any section of this chapter may have occurred or may be occurring, the department shall notify the alleged violator. The notice shall (i) be in writing; (ii) cite the statute or regulations that are allegedly being violated; (iii) state the facts that form the basis for believing that the violation may have occurred or may be occurring; and (iv) include information on the process for obtaining a final decision or fact finding from the department on whether or not a violation has occurred. This notification is not an official finding, case decision, or adjudication but may include a request to the owner to respond timely and to take specific corrective action by a stated deadline.

B. Orders. Pursuant to § 32.1-26 of the Code of Virginia, the board may issue orders to require any owner to comply with the provisions of any law administered by it, the commissioner, or the department; any regulations promulgated by the board, including any section of this chapter; or any case decision of the board or commissioner. The commissioner, acting on behalf of the board when it is not in session, will sign the order, and the order may require:

1. The immediate cessation or correction of the violation;

2. The acquisition or use of additional equipment, supplies, or personnel to ensure that the violation does not recur;

3. The submission of a plan to prevent future violations;

4. The submission of an application for a variance or exemption;

5. Any other corrective action deemed necessary for proper compliance with this chapter; or

6. An evaluation and approval of the required submissions, if appropriate.

C. Compliance with effective orders and this chapter. The commissioner may act as the agent of the board to enforce all effective orders and this chapter. Should any owner fail to comply with any effective order or this chapter, the commissioner may:

1. Institute an administrative proceeding to revoke the owner's permit in accordance with 12VAC5-590-320 and § 32.1-174 of the Code of Virginia or other appropriate administrative remedies;

2. Request the criminal prosecution by a Commonwealth's attorney with the appropriate jurisdiction in accordance with § 32.1-27 of the Code of Virginia;

3. Request civil action by the Attorney General to impose a civil penalty, seek injunctive relief, or other appropriate legal remedies pursuant to §§ 32.1-27 and 32.1-176 of the Code of Virginia; or

4. Do any combination of subdivision C 1, C 2, or C 3 of this section.

D. Special order. Pursuant to § 32.1-175.01 of the Code of Virginia, the commissioner may, after an informal fact-finding proceeding held in accordance with § 2.2-4019 of the Code of Virginia, issue a special order that may include a civil penalty against an owner who violates the Public Water Supplies Law, §§ 32.1-167 through 32.1-176 of the Code of Virginia, this chapter, or any order of the board.

E. Graduated enforcement actions. Nothing in this section shall prevent the commissioner or department from making efforts to obtain voluntary compliance through conference, warning, or other appropriate means before issuance of an order, instituting an administrative proceeding, or requesting an action by a Commonwealth's Attorney or the Attorney General.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-003.06 § 1.12, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-115 Administrative proceedings

A. Types of administrative proceedings. Administrative proceedings before the board, the commissioner, or the commissioner's designee, shall include the following forms depending upon the nature of the controversy and the interests of the named party involved.

1. An informal fact-finding proceeding is an informal conference between the department and the named party held in accordance with § 2.2-4019 of the Code of Virginia.

2. A formal hearing is an adjudicatory proceeding before the commissioner or a designated hearing officer held in accordance with § 2.2-4020 of the Code of Virginia.

B. Request for administrative proceeding. The named party may request an administrative proceeding by sending a request in writing to the department.

C. Administrative proceeding as a matter of right. The named party whose rights, duties, or privileges have been or may be affected by any action or inaction of the board, commissioner, or department in the administration of this chapter, has a right to both an informal fact-finding proceeding and a formal hearing; however, the commissioner reserves the right to require participation in an informal fact-finding proceeding before granting the request for a formal hearing.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-120 Emergency orders

A. The commissioner may, pursuant to § 32.1-175 of the Code of Virginia, issue emergency orders in any case where there is an imminent danger to the public health resulting from the operation of any waterworks or the source of a water supply.

B. An emergency order may be communicated by the best practical notice under all the circumstances and is effective immediately upon receipt. The commissioner may order the immediate cessation of the operation of any waterworks or the use of any water supply or the correction of any condition causing the production or distribution of any water constituting an imminent danger to the public health and welfare.

C. Violation of an emergency order is subject to civil enforcement and is punishable as a criminal misdemeanor.

D. Emergency orders shall be effective for a period determined by the commissioner.

E. Emergency orders may be appealed in accordance with the provisions of the APA.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-003.07 § 1.13, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-125 Chronically noncompliant waterworks

A. If the commissioner or department determines that a waterworks is a chronically noncompliant waterworks, as defined in § 32.1-167 of the Code of Virginia, then the commissioner shall issue an order to the owner containing a schedule to bring the waterworks into compliance with this chapter and require the submission of a waterworks business operation plan. If capital improvements are necessary to bring the waterworks into compliance, and the owner does not possess sufficient assets to make the necessary improvements, the order shall require the owner to make annual, good faith applications for loans, grants, or both, to appropriate financial institutions to secure funding for such improvements, until the improvements are complete and operational. The owner shall provide a copy of the order to each consumer within 10 calendar days of issuance of the order.

B. Within 15 calendar days of issuance of the commissioner's order, the owner shall certify in writing that a copy of the order was distributed to each consumer within the 10-day period specified in subsection A of this section.

C. The commissioner shall send a copy of the order to the chief administrative officer of the locality in which the waterworks is located for appropriate action under § 15.2-2146 of the Code of Virginia.

D. In addition to the provisions of § 32.1-27 of the Code of Virginia, any owner who violates this chapter, an order of the board, or a statute governing public water supplies shall be subject to those civil penalties provided in Article 2 (§ 32.1-167 et seq.) of Chapter 6 of Title 32.1 of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 19, eff. June 21, 2012; amended, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-130 Suspension of this chapter

If, in the case of a man-made or natural disaster, the commissioner determines that certain regulations cannot be complied with, then the enforcement of those regulations may be suspended for designated waterworks and a provisional regulatory scheme instituted until the conditions that brought about the suspension have abated.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-003.08 § 1.14, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-140 Variances

A. The commissioner may grant a variance to a PMCL, SMCL, treatment technique requirement, or an operational regulation by following the appropriate procedures set forth in this section.

1. Requirements for a variance. A variance may be granted to a waterworks from any requirement with respect to a PMCL or SMCL upon a finding that:

a. Alternative water supplies are not reasonably available to the waterworks;

b. The characteristics of the source water that is reasonably available to the waterworks prevents the waterworks from meeting the PMCL or SMCL requirements, and on condition that the waterworks installs the BAT, treatment techniques, or other means, that the department finds are generally available (taking costs into consideration); and

c. The granting of a variance will not result in an unreasonable risk to the health of persons served by the waterworks.

2. The commissioner may grant one or more treatment technique variances to a waterworks from any requirement of a specified treatment technique upon a finding that the waterworks applying for the variance has demonstrated that the treatment technique is not necessary to protect the health of persons because of the nature of the source water at the waterworks.

3. The commissioner may grant a variance to a waterworks from an operational regulation if a thorough investigation reveals that the hardship imposed outweighs the benefits that may be received by the public and that the granting of the variance does not subject the public to unreasonable health risks.

4. An operational variance may not be issued from monitoring, reporting, or public notification requirements.

B. Request for a variance. Any owner may apply in writing for a variance. The request shall be sent to the department for evaluation. All requests for a variance shall include the following:

1. A citation of the regulation from which a variance is requested;

2. The nature and duration of the variance requested;

3. Relevant analytical results of water quality sampling of the waterworks, including results of relevant tests conducted pursuant to the requirements of this chapter;

4. A statement of the hardship to the owner and the anticipated impacts to the public health and welfare if a variance were granted;

5. Suggested conditions that might be imposed on the granting of a variance that would limit its detrimental impact on public health and welfare;

6. Other information, if any, believed by the owner to be pertinent to the request; and

7. Any other information as may be required by the commissioner to make the determination.

C. For any request made for a PMCL variance, the owner shall also include:

1. An explanation in full and evidence of the BAT;

2. The economic and legal factors relevant to the owner's ability to comply;

3. The analytic results of source water quality relevant to the variance request;

4. A proposed compliance schedule including the date each step toward compliance will be achieved. The schedule shall include as a minimum the following dates:

a. The date by which arrangement for an alternative source water or improvement of an existing source water will be completed;

b. The date of initiation of the connection of the alternative source water or improvement of the existing source water; and

c. The date by which final compliance is to be achieved.

5. A plan for the provision of potable water in the case of an excessive rise in the contaminant level for which the variance is requested;

6. A plan for interim control measures during the effective period of the variance; and

7. A plan for notifying the consumers at least once every three months, or more frequently if determined by the commissioner, that the waterworks is operating under the conditions of a variance.

D. For any request made for a treatment technique variance, the owner must also include a statement that monitoring and other reasonable requirements prescribed by the commissioner as a condition to the variance will be performed.

E. Consideration of a variance request.

1. The commissioner shall act on any variance request submitted pursuant to subsection B of this section within 90 days of receipt of the submittal.

2. The commissioner will consider comments received during the comment period and testimony in the record of a public hearing held before making a determination.

3. In the commissioner's consideration of whether the waterworks is unable to comply with a contaminant level required by this chapter because of the nature of the source water, the commissioner shall consider such factors as the following:

a. The availability and effectiveness of BAT for which the variance is requested; and

b. The cost and other economic considerations such as implementing treatment, improving the quality of the source water, or using an alternate source.

4. In the commissioner's consideration of whether a waterworks should be granted a variance to a required treatment technique because the treatment is unnecessary to protect the public health, the commissioner shall consider such factors as the following:

a. Quality of the source water including water quality data and pertinent sources of pollution; and

b. Source protection measures employed by the waterworks.

5. In the commissioner's consideration of whether a waterworks should be granted a variance to a required operational procedure, the commissioner shall consider such factors as the following:

a. The effect that such a variance would have on the adequate operation of the waterworks, including operator safety in accordance with VOSH laws and regulations;

b. The cost and other economic considerations imposed by this requirement; and

c. The effect that such a variance would have on the protection of the public health.

F. Disposition of a variance request.

1. The commissioner may reject any request for a variance by sending a rejection notice to the applicant. The rejection notice shall be in writing and shall state the reasons for the rejection. A rejection notice constitutes a case decision. If the commissioner proposes to deny the variance, the owner shall be provided with an opportunity for an informal fact-finding proceeding as provided in § 2.2-4019 of the Code of Virginia.

2. If the commissioner grants the variance, the applicant shall be notified in writing of this decision. The notice shall identify the variance, the waterworks covered, and shall specify the period of time for which the variance will be effective.

a. For a PMCL variance as specified in subdivision A 1 of this section, the notice shall provide that the variance will be terminated when the waterworks comes into compliance with the applicable regulation and may be terminated upon a finding by the commissioner that the waterworks has failed to comply with any requirements of a final schedule issued pursuant to subdivision F 3 of this section.

b. For a treatment technique variance as specified in subdivision A 2 of this section, the notice shall provide that the variance may be terminated at any time upon a finding by the commissioner that the nature of the source water is such that the specified treatment technique for which the variance was granted is necessary to protect the public health or upon a finding that the waterworks has failed to comply with monitoring and other requirements prescribed by the commissioner as a condition to the granting of the variance.

c. For an operational variance as specified in subdivision A 3 of this section, the notice shall provide that the variance will be terminated when the waterworks comes into compliance with the applicable regulation and may be terminated upon a finding by the commissioner that the waterworks has failed to comply with any requirements or schedules issued in conjunction with the variance. The effective date of the operational variance shall be the date of its issuance. A public hearing is not required before the issuance of an operational variance.

3. Schedules pursuant to PMCL and treatment technique variances:

a. The proposed schedule for compliance shall specify dates by which steps toward compliance are to be taken, including where applicable:

(1) Date by which arrangement for the alternative source water or improvement of the existing source water will be completed;

(2) Date of connection to the alternative source water or improvement of the existing source water; and

(3) Date by which final compliance is to be achieved.

b. If the waterworks has no access to an alternative source water and can effect or anticipate no adequate improvement of the existing source water, then the proposed schedule may specify an indefinite time period for compliance until a new and effective treatment technology is developed, at which time a new compliance schedule shall be prescribed by the commissioner.

c. The schedule for implementation of interim control measures during the period of variance shall specify interim treatment techniques, methods, and equipment and dates by which steps toward meeting the interim control measures are to be met.

d. The schedule shall be prescribed by the commissioner at the time the variance is granted.

e. For a PMCL variance specified in subdivision A 1 of this section, the commissioner shall propose a schedule for:

(1) Compliance (including increments of progress) by the waterworks with each contaminant level requirement covered by the variance; and

(2) Implementation by the waterworks of such control measures as the commissioner may require for each contaminant level covered by the variance.

G. Public hearings on PMCL and treatment technique variances and their schedules.

1. Notice of a public hearing shall be provided before a variance and schedule proposed by the commissioner pursuant to subsection F of this section may take effect. A notice given pursuant to this subsection may cover the granting of more than one variance and a public hearing held pursuant to such notice shall include each of the variances covered by the notice.

2. Notice of a public hearing on a request for a variance and its schedule shall be advertised in at least one major newspaper of general circulation in the region in which the waterworks is located. The notice shall include a summary of the proposed variance and its schedule and shall contain the time, date, and place of the public hearing. If the schedule exceeds five years from the date of the variance, then the rationale for the extended compliance schedule shall be discussed in the notice.

H. Issuance of variance.

1. Within 30 days after the public hearing, the commissioner shall, taking into consideration information obtained during such hearing, revise the proposed variance as necessary and prescribe the final schedule for compliance and interim measures for the waterworks granted a variance. If the schedule for compliance exceeds five years from the date of issuance of the variance, then the commissioner shall document the rationale for the extended compliance schedule.

2. The compliance schedule shall establish the timetable by which the waterworks shall comply with each contaminant level and treatment technique requirement prescribed by this chapter. Such schedule shall also consider if the waterworks is to become part of a regional waterworks. The compliance schedule shall provide the shortest practicable time schedule under the circumstances.

I. Posting of variances. All variances granted to any waterworks are nontransferable. Each variance must be attached to the permit of the waterworks to which it is granted. Each variance is a condition to that permit and is revoked when the permit is revoked.

J. No variances shall be granted to 12VAC5-590-380, 12VAC5-590-388, 12VAC5-590-395, or 12VAC5-590-411.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-003.09 § 1.15, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 19, Issue 24, eff. September 10, 2003; Volume 21, Issue 16, eff. May 18, 2005; Volume 33, Issue 3, eff. November 2, 2016; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-150 Exemptions

A. The commissioner may grant an exemption to any PMCL or treatment technique requirement by following the procedures set forth in this section. An exemption may be granted to a waterworks upon a finding that:

1. The waterworks must be unable to implement measures to develop an alternative water supply;

2. The waterworks cannot reasonably make management or restructuring changes that will result in compliance or improve the quality of the drinking water;

3. Due to compelling factors (which may include economic factors), the waterworks is unable to comply with contaminant level or treatment technique requirements;

4. The granting of the exemption will not result in an unreasonable risk to the health of persons served by the waterworks;

5. The waterworks was in operation on the effective date of such contaminant level or treatment technique requirements; and

6. The waterworks has not been granted a variance.

B. The owner may request an exemption for a waterworks by submitting a written request to the department for evaluation. All requests for an exemption shall include the following information:

1. A citation to the regulation from which the exemption is requested;

2. The nature and duration of the exemption requested;

3. The relevant analytical results of water quality sampling of the waterworks, including results of relevant tests conducted pursuant to the requirements of this chapter;

4. An explanation of the compelling factors such as time or economic factors that prevent such waterworks from achieving compliance;

5. Other information believed by the owner to be pertinent to the request;

6. A proposed compliance schedule, including the date when each step toward compliance will be achieved; and

7. Other information as may be required by the commissioner to make the determination.

C. Consideration of an exemption request.

1. The commissioner shall act on any exemption request submitted pursuant to subsection B of this section within 90 days of receipt of the request.

2. In the commissioner's consideration of whether the waterworks is unable to comply due to compelling factors, the commissioner shall consider such factors as the following:

a. The construction, installation, or modification of treatment equipment or systems;

b. The time needed to put a new water treatment plant into operation to replace an existing water treatment plant that is not in compliance;

c. The economic feasibility of compliance;

d. The availability of Drinking Water State Revolving Fund, a department program to assist waterworks in achieving the public health protection objectives of the SDWA, assistance or any other federal or state program that is reasonably likely to be available within the period of the exemption;

e. The consideration of rate increases, accounting changes, the appointment of a licensed operator under the state operator's licensure program, or contractual agreements for joint operation with one or more waterworks;

f. The activities consistent with Virginia's capacity development strategy to help the waterworks acquire and maintain technical, financial, and managerial capacity to come into compliance;

g. The ownership changes, physical consolidation with another waterworks, or other feasible and appropriate means of consolidation that would result in compliance; and

h. The availability of an alternative source of drinking water, including the feasibility of partnerships with neighboring waterworks, as identified by the waterworks or by the commissioner consistent with the capacity development strategy.

D. Disposition of an exemption request.

1. The commissioner may reject any request for an exemption by sending a rejection notice to the owner. The rejection notice shall be in writing and shall state the reasons for the rejection. A rejection notice constitutes a case decision. If the commissioner proposes to deny the exemption, then the owner shall be provided with an opportunity for an informal fact-finding proceeding as provided in § 2.2-4019 of the Code of Virginia.

2. If the commissioner grants the exemption, then the owner shall be notified in writing of this decision. The notice shall identify the exemption and the waterworks covered and shall specify the termination date of the exemption. Exemptions shall be terminated when the waterworks comes into compliance with the applicable regulation and may be terminated upon a finding by the commissioner that the waterworks has failed to comply with any requirements of a final schedule issued pursuant to subsection F of this section.

3. The commissioner shall propose a schedule for:

a. Compliance (including increments of progress) by the waterworks with each contaminant level and treatment technique requirement covered by the exemption; and

b. Implementation by the waterworks of such control measures as the commissioner may require for each contaminant level and treatment technique requirement covered by the exemption.

4. The schedule shall be prescribed by the commissioner at the time the exemption is granted.

5. For a waterworks that serves a population of not more than 3,300 persons and that needs financial assistance for the necessary improvements under the initial compliance schedule, an exemption granted by the commissioner may be for one or more additional two-year periods, but not to exceed a total of six additional years, only if the commissioner establishes that the waterworks is taking all practicable steps to meet the requirements of the exemption and the established compliance period. The commissioner will document the findings in granting an extension under this subdivision.

E. Public hearings on exemptions and their schedules.

1. Notice of a public hearing shall be provided before an exemption and schedule proposed by the commissioner pursuant to subsection D of this section may take effect. Such notice may cover the granting of more than one exemption, and a public hearing held pursuant to the notice shall include each of the exemptions covered by the notice.

2. Notice of a public hearing on a request for an exemption and its schedule shall be advertised in at least one major newspaper of general circulation in the region in which the waterworks is located.

3. The notice shall include a summary of the proposed exemption and its schedule and shall contain the time, date, and place of the public hearing.

F. Issuance of exemption.

1. Within 30 days after the public hearing, the commissioner shall, taking into consideration information obtained during the hearing, revise the proposed exemption as necessary and prescribe the final compliance schedule and interim measures before issuing the exemption to the waterworks.

2. The schedule shall establish the timetable by which the waterworks shall comply with each contaminant level and treatment technique requirement prescribed by this section. If the schedule for compliance exceeds five years from the date of issuance of the exemption, then the commissioner shall document the rationale for the extended compliance period. Such schedule shall also consider if the waterworks is to become part of a regional waterworks.

G. Posting of exemptions. All exemptions granted to any waterworks are nontransferable. Each exemption must be attached to the operation permit of the waterworks to which it is granted. Each exemption is a condition to that permit and is revoked when the permit is revoked.

H. No exemption shall be granted to 12VAC5-590-380, 12VAC5-590-388, or 12VAC5-590-395.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-003.10 § 1.16, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 19, Issue 24, eff. September 10, 2003; Volume 21, Issue 16, eff. May 18, 2005; Volume 33, Issue 3, eff. November 2, 2016; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-160 (Repealed.)

History

• Historical Notes: Derived from VR355-18-003.11 § 1.17, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-170 (Repealed.)

History

• Historical Notes: Derived from VR355-18-003.12 § 1.18, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-180 (Repealed.)

History

• Historical Notes: Derived from VR355-18-003.13 § 1.19, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-190 Permits

A. No owner or other person may cause or allow any waterworks to be operated in the Commonwealth without a written operation permit issued by the commissioner.

B. No owner or other person shall cause or allow the construction or change in the manner of transmission, storage, purification, treatment, or distribution of water (including the extension of water pipes for the distribution of water) at any waterworks in the Commonwealth without a written construction permit or a general permit for distribution mains from the commissioner.

C. Construction permits may not be required for the extension of water distribution piping having a diameter of eight inches or less and serving less than 15 connections (see § 32.1-172 A of the Code of Virginia).

D. Individual construction permits for distribution mains are not required for waterworks that obtain a general permit (see 12VAC5-590-300).

E. Conditions may be imposed on the issuance of any permit, and no waterworks may be constructed, modified, or operated in violation of these conditions.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-003.14 § 1.20, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-200 Procedure for obtaining a construction permit

A. Construction permits are issued by the commissioner, but all requests for a construction permit are directed initially to the department. The procedure for obtaining a construction permit includes the following steps:

1. Owners shall notify the department of all proposed construction projects, except distribution main projects that are permitted under the provisions of a general permit for distribution mains (see 12VAC5-590-300), or when the project is for the extension of water distribution piping having a diameter of eight inches or less and serving less than 15 connections (see § 32.1-172 A of the Code of Virginia).

2. The submission of a Waterworks Permit Application to the department on a form approved by the department.

3. Based on the application received, the department shall notify the owner if a preliminary engineering conference is required. A preliminary engineering conference shall be required for projects proposed using alternative delivery methods authorized under § 2.2-4380 of the Code of Virginia. The preliminary engineering conference shall define the scope of the project, project phasing, milestones, and deliverables. An evaluation procedure shall be agreed upon and the conference shall be documented.

4. The submission of preliminary engineering or intermediate design reports if required by the department. The need for and scope of the reports shall be established during the preliminary engineering conference.

5. The submission of a waterworks business operation plan that demonstrates the waterworks TMF capabilities. The waterworks business operation plan consists of four primary components:

a. Waterworks information that includes ownership data, a waterworks facility description, operator requirements, staffing needs, and staff training.

b. Management information that identifies critical business practices necessary for effective management and operation of the waterworks. Management information includes the requirements essential for managing and operating the waterworks and defines the processes, methods, and tasks necessary for complying with this chapter.

c. Financial information that identifies projects, considering the waterworks revenues and cash flow, which will be sufficient for meeting the cost of operation and maintenance for at least five full years from the initiation of operations. Financial information also demonstrates the owner's ability to direct the waterworks' finances to support technical and managerial capacities and includes a self-assessment consisting of the following financial metrics: operating cash reserve, debt service coverage, emergency reserve, and revenue sufficiency.

d. Sustainability improvements that are identified throughout the waterworks business operation plan to address TMF aspects of the waterworks' business processes that need improvement.

6. The submission of plans, specifications, final design criteria, and other supporting design data. This submission may include manufacturers equipment data sheets, drawings, and specifications when the specific materials or equipment to be used in the project have been preselected by the owner with the engineer's concurrence.

B. Well site inspection. When, upon inspection by the department, one or more well locations are found suitable for well sites, tentative approval in writing shall be furnished to the owner authorizing the drilling of wells, the exact location where each well is to be drilled, and the well construction requirements. This tentative approval will become void after a 12-month period.

C. Plans for waterworks construction shall provide the following information, where applicable:

1. A general layout that includes:

a. Suitable title, to include name of waterworks;

b. Name of owner of waterworks;

c. Area or institution to be served;

d. Scale;

e. North Point;

f. Datum used;

g. Date, address, and name of owner's engineer;

h. Location and size of existing distribution system; and

i. Location and nature of existing waterworks structures and appurtenances affecting the proposed construction noted on one sheet.

2. Detailed plans that include, where applicable:

a. Stream crossings, providing profiles with elevations of the stream bed and the normal water level;

b. Profiles having a horizontal scale of not more than 100 feet to the inch and a vertical scale of not more than 10 feet to the inch, with both scales clearly indicated;

c. Location and size of property to be used for groundwater development with respect to known references such as street intersections or section lines;

d. Topography and arrangement of present or planned wells or structures, with contour intervals not greater than two feet;

e. Elevation of highest known flood, floor of structure, upper terminal of protective casing, and outside surrounding grade, using United States Coast and Geodetic Survey, United States Geological Survey, or equivalent elevations where applicable as a reference;

f. A completed Uniform Water Well Completion Report, Form GW-2, and schematic drawings of well construction, showing diameter and depth of drill holes, casing and liner diameters and depths, grouting depths, elevations and designation of geological formation, water levels, and other details to describe the proposed well completely;

g. If not previously submitted in the preliminary engineering report (PER): the location of all potential sources of pollution within 1,000 feet of drilled wells, 100 feet of treated water storage facilities, five miles upstream from surface water intakes, and the entire drainage area of springs;

h. Size, length, identity, and location of sewers, drains, distribution systems, and water treatment plant structures;

i. Schematic flow diagrams and hydraulic profiles showing the flow through various water treatment plant units;

j. Piping in sufficient detail to show flow through the water treatment plant, including waste lines;

k. Location of all chemical feeding equipment and points of chemical application;

l. All appurtenances, specific structures, equipment, water treatment plant waste disposal units, and point of discharge having any relationship to the plans for distribution system or waterworks structures;

m. Location of sanitary or other facilities such as lavatories, showers, toilets, and lockers;

n. Location, dimensions, and elevations of all proposed water treatment plant facilities; and

o. Adequate description of all features not otherwise covered by the specifications.

D. Specifications for waterworks construction improvements shall provide the following information, where applicable:

1. A program for keeping existing waterworks facilities in operation during construction of additional facilities so as to minimize interruption of service;

2. The laboratory facilities and equipment, as well as sampling taps and their locations;

3. The number and design of treatment process components;

4. The materials or proprietary equipment for sanitary or other facilities including any necessary backflow or backsiphonage backflow protection;

5. Workmanship; and

6. Other equipment.

E. Design criteria. A summary of complete design criteria shall be submitted for the proposed project, containing but not limited to the following information, where applicable:

1. Source water capacity;

2. Estimated water consumption, including average day, maximum day, and peak hour flows;

3. Number and type of proposed services;

4. Firefighting requirements;

5. Basin capacities;

6. Retention times;

7. Unit loadings;

8. Filter area and proposed filtration rate;

9. Backwash rate; and

10. Feeder capacities and ranges.

F. For community waterworks, a copy of the duly recorded (i) plat plan of the well lot or subdivision plan showing the well lot and (ii) dedication document stating that the well lot shall be used only for waterworks appurtenances as long as the lot is utilized as part of a waterworks.

G. For noncommunity waterworks, the department may on a case-by-case basis require a copy of a duly recorded plat plan of a well lot and a dedication document stating that the well lot shall be used only for waterworks appurtenances as long as the lot is utilized as part of a waterworks. In imposing such a requirement, the department shall take into consideration public health protection and the waterworks operations, treatment processes, and appurtenances.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-003.15 § 1.21, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-210 Requirements for the submission of engineering data

A. In accordance with Chapter 4 (§ 54.1-400 et seq.) of Title 54.1 of the Code of Virginia, all drawings, specifications, and engineer's reports submitted for approval shall be prepared by or under the supervision of a licensed professional engineer qualified to practice in Virginia, unless submitted under § 54.1-408 of the Code of Virginia for practice of land surveying in subdivisions.

B. The quantity, format, and method of submission shall meet the evaluation needs of the department and shall be consistent with the requirements in Chapter 42.1 (§ 59.1-479 et seq.) of Title 59.1 of the Code of Virginia.

C. All reports, plans, and specifications shall be submitted to the department at least 60 days before the date upon which action by the department or commissioner is desired.

D. If the procedures for obtaining a construction permit in 12VAC5-590-200 are not complied with or if plans and specifications are found to be incomplete or inadequate for evaluation, then the plans and specifications will be returned to the submitting party. If revisions to the plans or specifications or both are necessitated, the owner and engineer who prepared them will be notified in writing of the necessary revisions. Revised plans, specifications, or both constitute a resubmission. Every effort will be made to complete the evaluation of these revisions promptly.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-003.16 § 1.22, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-220 Compliance with the Manual of Practice

A. The design guidelines set forth in Part III Manual of Practice for Waterworks Design (12VAC5-590-640 et seq.) of this chapter (Manual of Practice) specify general criteria for the design and construction of waterworks. The commissioner may impose standards or requirements that are more stringent than those contained in the Manual of Practice when required to meet drinking water quality standards. Any special standards or requirements with a federal mandate shall take precedence over the criteria in the Manual of Practice and will be items that warrant careful consideration at the preliminary engineering conference, referenced in 12VAC5-590-200.

B. Designs submitted for waterworks must demonstrate that the waterworks will adequately safeguard public health. Submissions that are in substantial compliance with the Manual of Practice and any additional requirements of the commissioner, as noted in subsection A of this section, will be approved. Justification for a design may be required for those portions of the submitted design that differ from the criteria set forth in the Manual of Practice and any established by the commissioner. Deviations from mandatory criteria contained in the Manual of Practice shall be identified and justified. For each deviation, the commissioner may issue a design exception or require compliance with the criteria.

C. Final, complete, and detailed plans and specifications submitted in accordance with the provisions of 12VAC5-590-200 and 12VAC5-590-210 will be evaluated by the department as soon as practicable upon receipt. Plans and specifications will be approved if they demonstrate substantial compliance with the design criteria set forth in the Manual of Practice and any established by the commissioner and if the waterworks, as constructed or modified, will be able to function in compliance with Part II (12VAC5-590-340 et seq.) of this chapter.

D. Compliance with the Manual of Practice for transient noncommunity waterworks is allowed the following exceptions as long as the conditions in subsection E of this section are satisfied:

1. The design of a transient noncommunity waterworks is not required to satisfy the professional engineer licensure requirement of 12VAC5-590-210 under the following conditions:

a. The waterworks shall serve no more than 100 persons per day.

b. The waterworks shall consist only of one supply of source water, a pressure tank no greater than 250 gallon capacity, and a single service connection.

c. The single service connection shall be a building or structure of less than 5,000 square feet total floor space. The determination of square footage shall be calculated using the outside perimeter of the building or structure.

2. Although the owner of a transient noncommunity waterworks is required to use a water well systems provider certified by DPOR for drilling wells, the remainder of the waterworks facility construction at a transient noncommunity waterworks may be performed by a master plumber or a certified water well systems provider, as defined in § 54.1-1129.1 of the Code of Virginia.

E. The conditions for exceptions to the Manual of Practice for transient noncommunity waterworks specified in subsection D of this section are as follows:

1. The owner shall submit a signed and dated statement attached to the permit application, certifying that subsection D of this section will be satisfied.

2. The owner shall submit information related to the design, construction, and materials used as required by the department.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-003.17 § 1.23, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-230 Issuance of the construction permit

A. Upon approval of the plans and specifications, the commissioner will issue a permit to the owner to construct or modify the waterworks in accordance with the approved plans and specifications.

B. The construction permit shall be valid for a period of five years. If construction has not begun within five years but were to proceed in the future, then the owner shall reapply for a new construction permit.

C. The construction permit may include conditions for securing equipment certifications and performance validations.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-003.18 § 1.24, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-240 Revisions of approved plans

A. Any deviations from the approved plans and specifications affecting capacity, hydraulic conditions, operating units, the functioning of water treatment processes, or the quality of water to be delivered must be approved by the department before any of these deviations are implemented.

B. Revised plans and specifications shall be submitted in time to allow the evaluation and approval of these plans or specifications before any construction work that will be affected by these changes may begin.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-003.19 § 1.25, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-250 Statement required upon completion of construction

A. Upon completion of the construction or modification of the waterworks, the owner shall submit to the department a statement signed by a licensed professional engineer stating that the construction work was completed in accordance with the approved plans and specifications, revised only in accordance with the provisions of 12VAC5-590-240. This statement is called a statement of completion of construction and shall be based upon inspections of the waterworks during and after construction or modifications. These inspections are to be adequate to ensure the truth of the statement of completion of construction.

B. The project documents may require a performance validation report to confirm the design, performance criteria, and appropriate emergency procedures for specific processes and equipment. The project documents may also require operator training. If these requirements are included in the project documents, then the statement of completion of construction shall also include the performance validation report and a certification of successful operator training, as applicable.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-003.20 § 1.26, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-260 Issuance of the operation permit

A. Upon receipt of the statement of completion of construction, receipt of all required certifications and test results, inspection by the department to ensure that the project has been satisfactorily completed in accordance with the approved design documents, and verification that bacteriological test results comply with the requirements set forth in Part II of this chapter, as appropriate, the commissioner will issue an operation permit.

B. The owner shall not operate a waterworks without first having obtained an operation permit except as provided in 12VAC5-590-290.

C. The commissioner shall establish the type (community waterworks, NTNC, or TNC), classification, and permitted capacity of the waterworks and specify these on the operation permit. Conditions may be included with the permit for operator, monitoring, and reporting requirements.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-003.21 § 1.27, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-270 Start-up testing and inspections

A. Before placing a new or modified waterworks into operation following construction, the owner shall test the water at the entry point to the distribution system in a manner acceptable to the department. The owner shall notify the department of the time and place of the tests. The owner shall send the results of the tests to the department.

B. The commissioner and department have a right to inspect any waterworks and to be present for any testing in accordance with Title 32.1 of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-003.22 § 1.28, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-280 (Repealed.)

History

• Historical Notes: Derived from VR355-18-003.23 § 1.29, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-290 Issuance of a temporary operation permit

A. Water treatment methods, processes, and equipment that are not covered by the design criteria of Part III (12VAC5-590-640 et seq.) of this chapter, and that in principle or application are new or nonconventional, are subject to a temporary permit application procedure instead of that set forth in 12VAC5-590-200. A temporary permit may be issued only after detailed evaluation of all engineering data and after a period of extensive monitoring of the water treatment plant performance.

B. The department encourages the development of any new or nonconventional methods, processes, and equipment that by virtue of treatability studies appear to have application for water treatment. However, these new or nonconventional developments shall have been thoroughly tested in a full-scale or representative pilot plant installation before these methods, processes, and equipment are approved and an operation permit issued. The results shall be submitted to the department. The testing required on new or nonconventional developments shall generally follow these guidelines:

1. All procedures used in validating the process shall be conducted under the supervision of (i) a licensed professional engineer experienced in the field of environmental engineering, (ii) the owner's engineering staff, or (iii) a testing firm acceptable to the department;

2. Samples shall be collected and analyzed in a manner that shall demonstrate water treatment plant effectiveness and efficiency under adverse conditions and over extended periods of time in the area of the proposed installation;

3. The data shall be from the continuous operation of a full-scale or pilot plant treating the type of water to be handled;

4. Automatic indicating, recording, and totalizing equipment shall be provided, and the total flow shall be measured and recorded daily;

5. If the source water receives upstream discharges of treated industrial wastes or treated wastewater, then automatic indicating and recording equipment shall be provided for continuously monitoring the pH of the source and finished water in addition to the chlorine residual of the finished water;

6. The minimum sampling and analysis program will be established by the department in accordance with the process under investigation; and

7. All analyses shall utilize methods that are consistent with 12VAC5-590-440.

C. Detailed plans shall be submitted where possible showing how, in case of nonacceptance, the water treatment plant or water treatment methods, processes, and equipment will be converted to, or replaced with, a proven process. Also, financial resources must be assured to make the conversion (for example, funds placed in escrow or a bond posted.

D. After evaluation of the plans and testing data, the commissioner will issue a construction permit if the performance data verifies that the method, process, or equipment may efficiently produce water in accordance with the design specifications and the operation standards of Part II (12VAC5-590-340 et seq.) of this chapter.

E. Upon completion of construction or modification, a temporary permit for a definite period of time will be issued for the operation of the new or nonconventional methods, processes, and equipment. Not more than one temporary permit will be granted for a similar installation during the evaluation period. The temporary operation permit shall require that:

1. The evaluation period shall be a minimum of 12 months and no longer than 18 months; and

2. The holder of a temporary operation permit shall submit reports on operation during the evaluation period as required by the department. The reports shall be prepared by (i) a licensed professional engineer experienced in the field of environmental engineering, (ii) the owner's operating or engineering staff, or (iii) a testing organization.

F. The commissioner may issue a temporary operation permit if the waterworks is not in compliance with this chapter and public health will not be jeopardized. The temporary permit may be issued for a period of time and subject to conditions as the commissioner may deem appropriate for the owner to achieve compliance with this chapter.

1. The commissioner may require, as a condition to a temporary operation permit, the submission of a waterworks business operation plan by new waterworks and existing waterworks that have demonstrated limited TMF capabilities or significant noncompliance with this chapter.

2. The waterworks business operation plan shall satisfy the requirements of 12VAC5-590-200 A 5.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-003.24 § 1.30, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-300 Issuance of a general permit for construction of distribution mains

A. Instead of obtaining a permit for each distribution main project, an owner may elect to obtain a general permit for the construction of distribution mains. These general permits are issued by the commissioner, but all requests for a general permit are directed initially to the department.

B. The following requirements shall be satisfied for the issuance of a general permit:

1. The owner shall develop, adopt, and have the department's approval of general specifications and plan details covering distribution main design and construction. The general specifications shall be at least as stringent as the requirements contained in this chapter.

2. The owner shall enter into a memorandum of understanding (MOU) with the department. The department will outline the waterworks-specific requirements, and the owner's method of compliance with the requirements. The waterworks-specific requirements include the following:

a. The maximum size of pipe to be covered by the general permit;

b. The means for modifying the department's approved general specifications and plan details;

c. The maintenance of engineering capabilities satisfactory to the department, either on-staff or through contractual arrangements;

d. The preparation of engineering plans and specifications for individual projects;

e. The maintenance of up-to-date distribution system maps and other appropriate records; and

f. The submission by the owner to the department of appropriate reports, including an annual report and summary, concerning all projects constructed under the terms of the MOU and information concerning changes to the distribution system.

C. Once the general specifications are approved and the MOU is agreed to by the department, the commissioner will issue a general permit for distribution mains with the MOU attached.

D. The general permit allows for the construction of distribution mains. The duration for the general permit is five years.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-003.25 § 1.31, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-310 Amendment or reissuance of operation permits

A. The commissioner may amend or reissue an operation permit (i) when there is a change in the manner of storage, treatment, or supply of source water at the permitted location; (ii) when the existing permit is no longer valid; (iii) for any other cause incident to the protection of the public health; or (iv) for the supplying of potable water. A notice may be required to be given to the owner, and if one is required, a hearing held in accordance with the provisions of 12VAC5-590-115.

B. The commissioner may require submission of a waterworks business operation plan as a condition to amend or reissue an operation permit. The waterworks business operation plan shall satisfy the requirements of 12VAC5-590-200 A 5.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-003.26 § 1.32, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-320 Revocation of an operation permit

A. The commissioner may revoke an operation permit in accordance with the APA. Reasons for revocation include:

1. The waterworks can no longer be depended upon to furnish potable water;

2. The capacity of the waterworks is inadequate for the purpose of furnishing potable water;

3. The owner has failed to abide by an order issued by the commissioner;

4. The owner has abandoned the waterworks and discontinued supplying potable water; or

5. The owner has failed to pay the waterworks operation fee required by § 32.1-171.1 of the Code of Virginia.

B. Procedure for revocation of operation permit. When revoking an operation permit in accordance with subsection A of this section, the commissioner shall:

1. Send a written notice of intent to revoke by certified mail to the last known address of the owner. The notice shall state the reasons for the proposed revocation of the operation permit, the authority under which the commissioner proposes to act, and offer the opportunity for an administrative proceeding in accordance with 12VAC5-590-115.

2. Provide at least 30 days advance notice of the administrative proceeding.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-003.27 § 1.33, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-330 Monitoring, records, and reporting

A. The commissioner or department may require the owner to install, use, and maintain monitoring equipment for the control and testing of water flowing through the water treatment plant to:

1. Identify and determine the cause of operational problems;

2. Determine the necessary corrective actions for these problems;

3. Ensure compliance with Part II of this chapter; and

4. Prepare the finished water for entry into the distribution system.

B. Sampling and testing shall be by methods approved by the department. Test results shall be recorded, compiled, and reported to the department in an acceptable manner and format.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-003.28 § 1.34, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

Article 1 General [Repealed]

12VAC5-590-340 Compliance standards

A. All physical, chemical, bacteriological, or radiological analyses for the purpose of demonstrating compliance with the requirements of this chapter shall be performed by laboratories that have received certification by EPA or DCLS as specified in 12VAC5-590-440. The owner is responsible for the collection and submission of all samples. The department may require sampling and testing that exceeds the minimal requirements specified in this chapter. A sample is deemed to have been collected only when its results are made known to the department.

B. Specific limits. No attempt has been made to prescribe specific limits for every contaminant that might occur in a water supply or a waterworks. Although the need exists for continued attention to the entry of chemical, physical, bacteriological, and radiological substances into drinking water, the limits are confined to substances recognized as being detrimental to the health or well-being of the consumer or that cause significant degradation of the usefulness of the water. Limits for innumerable substances would require an impossible burden of analytical examination. The specific limits included in this chapter are listed in Tables 340.1 through 340.7.

C. Compliance is determined:

1. Based on sample results or calculated averages, where appropriate, rounded to the same number of significant figures as the PMCL, SMCL, AL, or MRDL of the contaminant in question, or

2. By the application of the specific treatment technique for particular contaminants (see 12VAC5-590-391).

| TABLE 340.1 Inorganic Chemicals | | | --- | --- | | SUBSTANCE | PMCL (mg/L) | | Antimony | 0.006 | | Arsenic | 0.010^a | | Asbestos | 7 million fibers/liter (longer than 10 µm) | | Barium | 2 | | Beryllium | 0.004 | | Cadmium | 0.005 | | Chromium | 0.1 | | Cyanide (as free Cyanide) | 0.2 | | Fluoride | 4.0^b | | Mercury | 0.002 | | Nickel | No limits designated | | Nitrate (as N) | 10^c | | Nitrite (as N) | 1.0^c | | Total Nitrate and Nitrite (as N) | 10^c | | Selenium | 0.05 | | Thallium | 0.002 | | SUBSTANCE | SECONDARY MAXIMUM CONTAMINANT LEVEL (mg/L) | | Aluminum | 0.05-0.2^d | | Chloride | 250^c | | Copper | 1.0 | | Corrosivity | Noncorrosive | | Fluoride | 2.0 | | Foaming agents | 0.5^e | | Iron | 0.3 | | Manganese | 0.05 | | Silver | 0.1 | | Sodium | No limits designated^f | | Sulfate | 250^c | | Zinc | 5 | | SUBSTANCE | ACTION LEVEL (mg/L) | | Lead | 0.015 | | Copper | 1.3 | | ^aArsenic sampling results shall be reported to the nearest 0.001 mg/L. ^bThe fluoride PMCL applies only to community waterworks. ^cSignificant figures are noted as shown. For values with trailing zeros, significant figures are noted as shown. The limits for nitrate and nitrate-nitrite have two significant figures. The limits for chloride and sulfate have three significant figures. ^dVarying water quality and treatment situations necessitates a flexible range for the aluminum SMCL. The owner is encouraged to maintain an aluminum concentration as low as possible. If the aluminum concentration in the finished water causes discoloration, then the owner is urged to contact the department. ^eConcentrations reported in terms of Methylene Blue Active Substances. ^fMonitoring and reporting in accordance with 40 CFR 141. 41 and 12VAC5-590-372 D 6. | |

| TABLE 340.2 Organic Chemicals | | | --- | --- | | SUBSTANCE | PMCL (mg/L) | | VOC | | | Benzene | 0.005 | | Carbon tetrachloride | 0.005 | | Chlorobenzene (also called Monochlorobenzene) | 0.1 | | o-Dichlorobenzene | 0.6 | | p-Dichlorobenzene | 0.075 | | 1,2-Dichloroethane (also called Ethylene dichloride) | 0.005 | | 1,1-Dichloroethylene (also called Dichloroethene) | 0.007 | | cis-1,2-Dichloroethylene | 0.07 | | Trans-1,2-Dichloroethylene | 0.1 | | Dichloromethane (also called Methylene chloride) | 0.005 | | 1,2-Dichloropropane | 0.005 | | Ethylbenzene | 0.7 | | Styrene | 0.1 | | Tetrachloroethylene (PCE) (also called Perchloroethylene) | 0.005 | | Toluene | 1 | | 1,2,4-Trichlorobenzene | 0.07 | | 1,1,1-Trichloroethane | 0.2 | | 1,1,2-Trichloroethane | 0.005 | | Trichloroethylene (TCE) | 0.005 | | Vinyl Chloride | 0.002 | | Xylene (total) | 10^a | | SOC | | | Acrylamide | TT^b | | Alachlor (also called Lasso) | 0.002 | | Atrazine | 0.003 | | Benzo(a)pyrene | 0.0002 | | Carbofuran | 0.04 | | Chlordane | 0.002 | | Dalapon | 0.2 | | Di(2-ethylhexyl)adipate (also called Bis(2-ethylhexyl)adipate) | 0.4 | | Di(2-ethylhexyl)phthalate (also called Bis(2-ethylhexyl)phthalate) | 0.006 | | 1,2-Dibromo-3-chloropropane (DBCP) | 0.0002 | | 2,4-Dichlorophenoxyacetic Acid (2,4-D) | 0.07 | | Dinoseb | 0.007 | | Diquat | 0.02 | | Endothall | 0.1 | | Endrin | 0.002 | | Epichlorohydrin | TT^b | | Ethylene dibromide (EDB) (also called 1,2-Dibromoethane) | 0.00005 | | Glyphosate | 0.7 | | Heptachlor | 0.0004 | | Heptachlor epoxide | 0.0002 | | Hexachlorobenzene | 0.001 | | Hexachlorocyclopentadiene | 0.05 | | Lindane (also called gamma-HCH and gamma BHC) | 0.0002 | | Methoxychlor | 0.04 | | Oxamyl (Vydate) | 0.2 | | Pentachlorophenol (PCP) | 0.001 | | Picloram | 0.5 | | Polychlorinated biphenyls (PCBs) | 0.0005 | | Simazine | 0.004 | | 2,3,7,8-TCDD (Dioxin) | 3 X 10^-8 | | Toxaphene | 0.003 | | 2,4,5-Trichlorophenoxypropionic Acid (2,4,5-TP or Silvex) | 0.05 | | ^aThe limit for xylene has two significant figures. ^bEach waterworks must certify annually to the department that when acrylamide and epichlorohydrin are used to treat water, the combination (or product) of dose and monomer level does not exceed the levels specified as follows: (i) acrylamide = 0.05% dosed at 1 mg/L (or equivalent) and (ii) epichlorohydrin = 0.01% dosed at 20 mg/L (or equivalent). The certification shall be in writing, using third-party certification approved by the department or the manufacturer's certification. | |

| TABLE 340.3 Physical Quality | | | | --- | --- | --- | | PARAMETER | STANDARD | CONCENTRATION | | Color | SMCL | 15 Color Units (CU) | | Odor | SMCL | 3 Threshold odor numbers | | pH | SMCL | 6.5-8.5 | | Total dissolved solids (TDS) | SMCL | 500 mg/L^a | | Turbidity | Treatment Technique | See 12VAC5-590-395 A 2 b^b | | ^aTDS has three significant figures. ^bOperational goal: Surface water treatment plants with gravity flow granular media filters are capable of producing filtered water with a turbidity consistently less than 0.10 NTU. Therefore, for water treatment plants, the operational goal for filter effluent turbidity for each filter, before any post-filtration chemical addition, is 0.10 NTU. | | |

| TABLE 340.4 Radiological Quality | | | | --- | --- | --- | | PARAMETER | PMCL | | | Combined radium-226 and radium-228. | 5 pCi/L | | | Gross alpha particle activity (excluding Radon and Uranium) | 15 pCi/L | | | Beta particle and photon radioactivity. | 4 mrem/yr ^{a, b} | | | Uranium | 30 µg/L^c | | | ^aThe average annual concentration of beta particle and photon radioactivity from man-made radionuclides in drinking water shall not produce an annual dose equivalent to the total body or any internal organ greater than 4 mrem/year. ^bExcept for the radionuclides listed in Schedule I, the concentration of man-made radionuclides causing 4 mrem total body or organ dose equivalents shall be calculated on the basis of a 2 liter per day drinking water intake using the 168-hour data listed in "Maximum Permissible Body Burdens and Maximum Permissible Concentrations of Radionuclides in Air and in Water for Occupational Exposure," NBS Handbook 69 issued June 5, 1959, and amended August 1963, U.S. Department of Commerce. If two or more radionuclides are present, the sum of their annual dose equivalent to the total body or to any organ shall not exceed 4 mrem/year. ^cThe limit for uranium has two significant figures. | | | | | | | | Schedule 1 | | | | Average annual concentrations assumed to produce a total body organ dose of 4 mrem/year. | | | | RADIONUCLIDE | CRITICAL ORGAN | pCi/L | | Tritium | Total Body | 20,000^d | | Strontium-90 | Bone Marrow | 8 | | ^dThe limit for tritium has five significant figures. | | |

| TABLE 340.5 Microbial Contaminants | | | --- | --- | | CONTAMINANT | PMCL or TT | | Cryptosporidium | TT Minimum 99% (2-log) removal plus additional log removal or inactivation based upon bin classification in 12VAC5-590-401 D. | | Giardia lamblia | TT 99.9% (3-log) removal or inactivation. | | Viruses | TT 99.99% (4-log) removal or inactivation | | Legionella | TT No limit, but if Giardia lamblia and viruses are removed or inactivated, according to the treatment techniques in 12VAC5-590-395, Legionella will also be controlled. | | Heterotrophic plate count (HPC) | TT No more than 500 bacterial colonies per milliliter. (HPC is not a contaminant, it is an analytic method used to measure a variety of bacteria found in water.) | | Escherichia coli (E. coli) | PMCL (1) Any E. coli-positive repeat sample following a total coliform-positive routine sample. (2) Total coliform-positive repeat sample following an E. coli-positive routine sample. (3) Failure to collect all require repeat samples following an E. coli-positive routine sample. (4) Failure to test for E. coli when any repeat sample tests positive for total coliform. |

| TABLE 340.6 Disinfection Byproducts | | | --- | --- | | PARAMETER | PMCL (mg/L) | | TTHM Bromodichloromethane Bromoform Chloroform Dibromochloromethane | 0.080^a | | HAA5 Bromoacetic acid Dibromoacetic acid Dichloroacetic acid Monochloroacetic acid Trichloroacetic acid | 0.060^a | | Bromate | 0.010^a | | Chlorite | 1.0^a | | ^aThe limits for TTHM, HAA5, and bromate have three significant figures. The limit for chlorite has two significant figures. | |

| TABLE 340.7 Maximum Residual Disinfectant Level Goals (MRDLG) and Maximum Residual Disinfectant Levels (MRDL) for Disinfectants | | | --- | --- | | RESIDUAL DISINFECTANT | MRDLG and MRDL (mg/L) | | Chlorine | 4.0 (as Cl₂)^a | | Chloramines | 4.0 (as Cl₂)^a | | Chlorine Dioxide | 0.8 (as ClO₂) | | ^aChlorine and chloramines have two significant figures. | |

D. Notwithstanding the MRDLs in Table 340.7, an owner may increase the residual disinfectant level of chlorine or chloramines (but not chlorine dioxide) in the distribution system to a level and for a time necessary to protect public health. This may include specific microbiological contamination problems caused by circumstances such as distribution line breaks, storm runoff events, water supply contamination events, or cross-connection events.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-004.01 § 2.1, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 12, Issue 2, eff. November 15, 1995; Volume 28, Issue 5, eff. December 7, 2011; Volume 37, Issue 20, eff. June 23, 2021; Errata, 37:22 VA.R. 3447 June 21, 2021.

12VAC5-590-350 Assessments and sanitary surveys

A. Frequent assessments shall be made by the owner of the water supply and waterworks to locate and identify health hazards to the waterworks. The manner and frequency of making these assessments, and the rate at which discovered health hazards are to be removed, shall be the responsibility of the owner. Every effort shall be made by the owner, to the extent of his jurisdiction, to prevent the degradation of the quality of water supplies.

B. The department is required to perform sanitary surveys and site visits to assess the condition of a waterworks and its source water. Pursuant to § 32.1-25 of the Code of Virginia, the department shall, upon presentation of appropriate credentials and with the owner's consent, have the right of entry onto the waterworks property and the facilities to inspect, investigate, evaluate, conduct tests, and collect samples for testing for the purposes of determining compliance with the provisions of any law, regulation, or order administered by the board or commissioner or any conditions in a permit, license, or certificate issued by the board or commissioner. The owner shall provide any existing information requested by the department that will enable the department to conduct the sanitary survey or site visit.

C. A sanitary survey includes an evaluation of all of the following eight components:

1. Source;

2. Treatment;

3. Distribution system;

4. Finished water storage;

5. Pumps, pumping facilities, and controls;

6. Monitoring, reporting, data verification, and a special monitoring evaluation during each sanitary survey to determine whether the waterworks monitoring is appropriate or needs modification;

7. Waterworks system management and operation; and

8. Number and classification of operators. Operators shall also comply with all applicable regulations promulgated by the Virginia Board for Waterworks and Wastewater Works Operators and Onsite Sewage System Professionals and DPOR.

D. Significant deficiencies discovered as a result of a sanitary survey shall be addressed in accordance with the following:

1. The department shall issue written notification describing the significant deficiency to the owner.

2. Within 30 days of the significant-deficiency notification, the owner shall consult with the department regarding the appropriate corrective action with a schedule for implementing the corrective action. A waterworks with one or more significant deficiencies must have a CAP as described in 12VAC5-590-421 A.

3. Within 45 days of the significant-deficiency notification, the owner shall submit to the department a CAP with a schedule for meeting the requirements of 12VAC5-590-421 A.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-004.02 § 2.2, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 28, Issue 5, eff. December 7, 2011; Volume 33, Issue 3, eff. November 2, 2016; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-360 Responsibilities of the owner

A. The owner shall provide and maintain conditions throughout the entirety of the waterworks in a manner that will assure a high degree of capability and reliability to comply with Part II (12VAC5-590-340 et seq.) of this chapter. This requirement shall pertain to the source water, transmission, treatment, storage, and distribution system facilities and the operation thereof. The owner shall identify and evaluate factors with the potential for impairing the quality of the water delivered to the consumers. Preventative control measures identified in Part II of this chapter shall be promptly implemented to protect public health.

B. For the purpose of achieving compliance with this chapter, the owner shall exercise control of the waterworks from the source water to the service connection. This requirement does not imply ownership of or maintenance for any portion of the service line where local agreements and conditions dictate otherwise.

C. The property owner shall exercise control of all buildings, structures, and equipment up to the point of the service connection to the waterworks. This requirement does not limit or modify ownership of or maintenance for the service line, that may be specified by local agreements and conditions.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-004.03 § 2.3, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

Article 2 General Information [Repealed]

12VAC5-590-370 Monitoring requirements

A. Bacteriological monitoring.

1. The owner shall collect total coliform samples at specific sites and according to a schedule that is representative of water quality throughout the distribution system, which shall be documented in a written BSSP. The BSSP shall be established or approved by the department after investigation of the source water, method of treatment and storage, and the final delivery of the drinking water through the distribution system. The BSSP shall include the following:

a. Specific routine, repeat, and triggered source water monitoring sites, identified by address or location.

b. Distribution maps showing the location where specific sampling sites will be selected with all monitoring sites identified.

c. A minimum of three routine sample sites identified for each required routine sample for waterworks serving 3,300 or fewer people.

d. A sample collection schedule with the number of routine samples required per monitoring period in accordance with Table 370.1 and subdivision A 4 of this section.

e. Repeat sample sites for each routine sample site that shall include the original routine location, at least one tap within five service connections upstream, and at least one tap within five service connections downstream with the following exceptions:

(1) Alternative repeat sample sites may be allowed when a routine site is one connection away from or at the end of a distribution system main or as approved by the department;

(2) A groundwater system serving 1,000 or fewer people may propose repeat sample sites, such as an entry point to the distribution system, that differentiate potential source water and distribution system contamination; or

(3) A groundwater system serving 1,000 or fewer people with a single well source and no treatment may propose that one repeat sample be collected at the triggered source water monitoring site, provided that representative sampling of the distribution system is still achieved.

f. A repeat sampling site shall not be eliminated from future collections solely based on a history of questionable water quality unless the sampling point is unacceptable as determined by the department.

g. A seasonal waterworks may collect special samples in accordance with an approved start-up procedure pursuant to subdivision A 12 a of this section.

2. The minimum number of bacteriological samples for total coliform evaluation to be collected and analyzed monthly from the distribution system of a community waterworks, or a NTNC shall be in accordance with Table 370.1. The owner of a (i) TNC that uses a surface water source or a groundwater source under the direct influence of surface water or (ii) a large TNC (serving 1,000 or more persons per day) shall collect and submit samples monthly for analysis in accordance with Table 370.1. For all other TNCs, the owner shall collect and submit samples for analysis each calendar quarter in accordance with Table 370.1. The minimum number of samples must be collected and submitted even if the waterworks has exceeded the E. coli PMCL or the total coliform treatment technique triggers.

3. The samples shall be collected at evenly spaced time intervals as practical throughout the month, except that a waterworks that uses only groundwater and serves 4,900 or fewer people may have the required samples collected on a single day if the samples are collected from different sites.

4. If the results of a sanitary survey or other factors determine that some other frequency is more appropriate than that stated in subdivisions A 2 and A 3 of this section, then a modified BSSP may be required. The altered frequency shall be confirmed or changed on the basis of subsequent sanitary surveys or as otherwise determined by the department.

5. The owner may conduct more compliance monitoring than is required by this section to investigate potential problems in the distribution system and to assist in uncovering problems. The owner may collect more than the minimum number of required routine samples. If the samples are collected in accordance with the existing BSSP and are representative of water quality throughout the distribution system, then all of the results shall be included in determining whether a coliform treatment technique has been triggered.

6. The owner may propose repeat monitoring locations believed to be representative of a pathway for contamination of the distribution system. The owner may elect to specify either alternative fixed locations or criteria for selecting repeat sampling sites on a situational basis in a SOP in its BSSP. The owner shall design the SOP to focus on the collection of repeat samples at locations that best verify and determine the extent of potential contamination of the distribution system based on specific situations. The department shall require modifications to the SOP or require alternative monitoring locations as needed.

| TABLE 370.1 Bacteriological Monitoring | | | --- | --- | | POPULATION SERVED PER DAY | MINIMUM NUMBER OF SAMPLES^a | | 25 to 1,000^b | 1 | | 1,001 to 2,500 | 2 | | 2,501 to 3,300 | 3 | | 3,301 to 4,100 | 4 | | 4,101 to 4,900 | 5 | | 4,901 to 5,800 | 6 | | 5,801 to 6,700 | 7 | | 6,701 to 7,600 | 8 | | 7,601 to 8,500 | 9 | | 8,501 to 12,900 | 10 | | 12,901 to 17,200 | 15 | | 17,201 to 21,500 | 20 | | 21,501 to 25,000 | 25 | | 25,001 to 33,000 | 30 | | 33,001 to 41,000 | 40 | | 41,001 to 50,000 | 50 | | 50,001 to 59,000 | 60 | | 59,001 to 70,000 | 70 | | 70,001 to 83,000 | 80 | | 83,001 to 96,000 | 90 | | 96,001 to 130,000 | 100 | | 130,001 to 220,000 | 120 | | 220,001 to 320,000 | 150 | | 320,001 to 450,000 | 180 | | 450,001 to 600,000 | 210 | | 600,001 to 780,000 | 240 | | 780,001 to 970,000 | 270 | | 970,001 to 1,230,000 | 300 | | 1,230,001 to 1,520,000 | 330 | | 1,520,001 to 1,850,000 | 360 | | 1,850,001 to 2,270,000 2,270,001 to 3,020,000 3,020,001 to 3,960,000 3,960,001 or more | 390 420 450 480 | | ^aMonthly monitoring is required for the following waterworks: (i) community, (ii) nontransient noncommunity, (iii) all noncommunity waterworks that use a surface water source, a GUDI source, or both, (iv) all seasonal waterworks, and (v) large noncommunity (serving more than 1,000 people per day). Quarterly monitoring is required for noncommuntity waterworks not specifically identified in the monthly requirements. Annual monitoring may be allowed at a TNC that meets the criteria specified in subdivision A 8 of this section. ^bIncludes a waterworks that have at least 15 service connections, but serve fewer than 25 persons. | |

7. All bacteriological analyses shall be performed in accordance with 12VAC5-590-440 by the DCLS or by a laboratory certified by the DCLS for drinking water samples.

8. Annual monitoring. The department may reduce the bacteriological monitoring frequency at a well-operated TNC from a quarterly sample to one annual sample, and the waterworks may remain at the annual monitoring frequency provided that all of the following conditions are continuously met:

a. The waterworks serves 1,000 or fewer people per day.

b. The waterworks uses groundwater only and is not under the influence of surface water.

c. The waterworks has a clean compliance history for a minimum of 12 consecutive months.

d. The most recent sanitary survey shows that the waterworks is free of sanitary defects or has corrected all identified sanitary defects.

e. The waterworks has a protected water source.

f. The waterworks meets existing approved construction standards.

g. The department has conducted an annual site visit within the last 12 months, and all identified sanitary defects have been corrected. For the purposes of this section, an annual site visit is equivalent to a voluntary Level 2 assessment that meets the criteria in 12VAC5-590-392 C. A sanitary survey may meet the requirement for an annual site visit in the year in which the sanitary survey is completed if all identified sanitary defects have been corrected.

9. Increased monitoring.

a. A TNC on quarterly or annual monitoring shall begin monthly monitoring in the month following an event if any of the following occurs: (i) the waterworks triggers a Level 2 assessment or two Level 1 assessments under the provisions of 12VAC5-590-392 in a rolling 12-month period, (ii) the waterworks has an E. coli PMCL violation, (iii) the waterworks has a coliform treatment technique violation, (iv) the owner has two monitoring violations under 12VAC5-590-370 A 2, or (v) the owner has one monitoring violation under 12VAC5-590-370 A 2 and one Level 1 assessment under 12VAC5-590-392 in a rolling 12-month period. The owner shall continue monthly monitoring until the requirements in subdivisions A 10 a and A 10 b of this section are met. A waterworks on monthly monitoring for other reasons is not considered to be on increased monitoring for the purpose of this subdivision.

b. A TNC on annual monitoring that experiences one monitoring violation of 12VAC5-590-370 must begin quarterly monitoring in the quarter following the event. The owner shall continue quarterly monitoring until the conditions in subdivision A 11 of this section are continuously met and the department reduces the monitoring frequency.

10. Returning to quarterly routine monitoring. The department may return the monitoring frequency of a TNC subject to subdivision A 9 a of this section and using groundwater not under the influence of surface water to quarterly monitoring if:

a. The department has completed a sanitary survey or a site visit within the last 12 months, and the TNC is free of sanitary defects and has a protected water source; and

b. The waterworks has maintained a clean compliance history for a minimum of 12 consecutive months following the event.

11. Returning to annual routine monitoring. The department may reduce the monitoring frequency of a TNC subject to subdivision A 9 of this section and using groundwater not under the influence of surface water to annual monitoring if:

a. An annual site visit or sanitary survey is conducted by the department, and all identified sanitary defects are corrected. The waterworks may substitute a voluntary Level 2 assessment for the annual site visit.

b. The waterworks has a protected water source and maintained a clean compliance history for a minimum of 12 consecutive months following the event.

c. The waterworks has in place or has adopted one or more of the following additional barriers to contamination: (i) an approved cross-connection control program, (ii) a licensed operator, (iii) continuous disinfection and maintenance of a residual in the distribution system in accordance with criteria specified by the department, (iv) demonstration of maintenance of at least a 4-log removal or inactivation of viruses in accordance with 12VAC5-590-379 A, or (v) other equivalent enhancements approved by the department.

12. Seasonal waterworks monitoring.

a. A seasonal waterworks shall demonstrate completion of an approved start-up procedure that may include start-up sampling before serving water.

b. A seasonal waterworks shall monitor every month that it is in operation.

c. The department may waive any seasonal waterworks from some or all of the requirements for seasonal waterworks if the entire distribution system remains pressurized during the entire period that the waterworks is not operating.

d. Failure to complete an approved start-up procedure before serving water is a treatment technique violation and requires the owner to provide public notification under Tier 2 conditions in 12VAC5-590-540 A 2.

e. Failure to submit certification of completion to the department after the owner completes an approved start-up procedure is a reporting violation and requires the owner to provide public notification under Tier 3 conditions in 12VAC5-590-540 A 3.

13. Additional routine monitoring in the month following a total coliform-positive sample.

a. The owner collecting samples on a quarterly or annual frequency shall collect at least three additional routine samples during the month following one or more total coliform-positive samples, with or without a Level 1 treatment trigger. The owner shall use the results of additional routine samples in coliform treatment technique trigger calculations under 12VAC5-590-392 B.

b. The requirements specified in subdivision A 13 a of this section may be waived by the department if:

(1) The department conducts a site visit before the end of the next month in which the waterworks provides water and has determined whether additional monitoring or corrective action is needed;

(2) The department has determined why the sample was total coliform positive and has established that the owner corrected the problem or will correct the problem before the end of the next month in which the waterworks serves water. In this case, the decision and the rationale for the decision shall be documented and approved in writing by the department. The department shall make this document available to EPA and the public. The documentation shall describe the specific cause of the total coliform-positive sample and what action the owner has taken or will take to correct this problem; or

(3) The department determines that the owner has corrected the contamination problem before collecting the set of repeat samples required in 12VAC5-590-380 D 3, and all repeat samples are total coliform negative. The department may waive the requirement for additional routine monitoring the next month.

c. The requirements specified in subdivision A 13 a of this section may not be waived by the department solely on the grounds that all repeat samples are total coliform negative.

14. Any one of the following is a monitoring violation: (i) failure to collect every required routine or additional routine sample in a compliance period, and (ii) failure to analyze for E. coli following a total coliform-positive sample. For each violation, the owner is required to provide public notification under Tier 3 conditions in 12VAC5-590-540 A 3.

15. Any one of the following is a reporting violation: (i) failure to submit monitoring results after the owner properly conducts monitoring, (ii) failure to submit a completed assessment form, and (iii) failure to notify the department following an E. coli-positive sample. The reporting requirements in 12VAC5-590-530 are applicable to this subdivision. For each violation, the owner is required to provide public notification under Tier 3 conditions in 12VAC5-590-540 A 3.

B. Chemical monitoring. The location of sampling points, the chemicals measured, the frequency, and the timing of sampling within each compliance period shall be established or approved by the department at the time of issuance of a waterworks operation permit because of changes in this chapter or conditions at the waterworks.

1. The department may increase required monitoring where necessary to detect variations within the waterworks and to provide quality control for any treatment processes that are employed.

2. Analysis of field composite samples shall not be allowed.

3. Samples for contaminants that may exhibit seasonal variations shall be collected during the period of the year when contamination is most likely to occur.

4. Failure to comply with the sampling schedules in this section, which includes the collection of confirmation samples cited in 12VAC5-590-382 A for inorganic chemicals, 12VAC5-590-382 B for nitrate and nitrite, and 12VAC5-590-383 A for organic chemicals, is a monitoring violation and shall require public notification pursuant to 12VAC5-590-540 A 3.

C. The department may allow a consecutive waterworks that obtains potable water from another waterworks to limit monitoring to bacteriological, residual disinfectant, DBPs, and lead and copper.

D. Monitoring requirements for a waterworks developing new sources of source water are provided in 12VAC5-590-820, 12VAC5-590-830, and 12VAC5-590-840.

E. The department may require an owner to collect additional samples to provide quality control for any treatment processes that are employed.

F. Surface water sampling requirements specified in 12VAC5-590-372 through 12VAC5-590-378 apply to GUDI sources.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-004.04 § 2.4, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 12, Issue 2, eff. November 15, 1995; Volume 16, Issue 21, eff. August 3, 2000; Errata, 18:22 VA.R. 2953 July 15, 2002; amended, Virginia Register Volume 18, Issue 19, eff. July 3, 2002; Volume 19, Issue 17, eff. June 4, 2003; Volume 19, Issue 24, eff. September 10, 2003; Volume 21, Issue 13, eff. April 6, 2005; Volume 22, Issue 15, eff. May 3, 2006; Volume 22, Issue 24, eff. September 6, 2006; Volume 25, Issue 5, eff. December 10, 2008; Volume 27, Issue 1, eff. October 13, 2010; Volume 28, Issue 5, eff. December 7, 2011; Volume 33, Issue 3, eff. November 2, 2016; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-372 Inorganic chemicals monitoring

A. The owner of a community waterworks or a NTNC shall conduct monitoring to determine compliance with the PMCLs and SMCLs listed in Table 340.1 in accordance with this section. The owner of a TNC shall conduct monitoring to determine compliance with the nitrate, nitrite, and nitrate-nitrite PMCLs listed in Table 340.1 in accordance with this section.

B. If a waterworks draws water from more than one source and the sources are combined before distribution, then the owner shall sample at an entry point to the distribution system during periods of normal operating conditions (i.e., when water is representative of all sources being used).

C. When the results of sampling for antimony, arsenic, asbestos, barium, beryllium, cadmium, cyanide (as free cyanide), chromium, fluoride, mercury, nickel, selenium, or thallium exceed the applicable PMCL, the owner shall collect a confirmation sample, at the same sampling site, within two weeks of notification of the analytical results of the first sample.

D. Monitoring frequency.

1. Asbestos. The department has granted a statewide waiver for asbestos. If the statewide waiver is removed or if site-specific waterworks conditions warrant monitoring for asbestos, then monitoring to determine compliance with the PMCL for asbestos specified in Table 340.1 shall be conducted as follows:

a. The owner of a community waterworks or a NTNC shall monitor for asbestos during the first three-year compliance period of each nine-year compliance cycle.

b. If the statewide waiver is removed, and the owner believes the waterworks is not vulnerable to asbestos contamination from either its source water or due to corrosion of its asbestos-cement pipe, then the owner may apply to the department for a monitoring waiver for asbestos. If the department grants the monitoring waiver, then the owner is not required to monitor.

c. The department may grant a waiver based on a consideration of the following factors:

(1) Potential asbestos contamination of the source water; and

(2) The use of asbestos-cement pipe for finished water distribution and the corrosive nature of the water.

d. A waiver remains in effect until the completion of the compliance period (i.e., three years).

e. The owner of a waterworks vulnerable to asbestos contamination due solely to corrosion of its asbestos-cement pipe shall collect one sample at a tap served by the asbestos-cement pipe and under conditions where asbestos contamination is most likely to occur.

f. The owner of a waterworks vulnerable to asbestos contamination due to its source water shall monitor at the entry points.

g. The owner of a waterworks vulnerable to asbestos contamination due both to its source water and corrosion of its asbestos-cement pipe shall collect one sample at a tap served by the asbestos-cement pipe and under conditions where asbestos contamination is most likely to occur.

h. The owner of a waterworks that exceeds the PMCL as determined in 12VAC5-590-382 A shall monitor quarterly beginning in the next quarter after the exceedance occurred.

i. The department may decrease the quarterly monitoring requirement to the frequency specified in subdivision D 1 a of this section provided the department has determined that the waterworks is reliably and consistently below the PMCL. In no case shall the department make this determination unless the owner of a groundwater system collects a minimum of two quarterly samples or the owner of a waterworks that uses a surface water source, in whole or in part, collects a minimum of four quarterly samples.

2. Antimony, arsenic, barium, beryllium, cadmium, chromium, cyanide (as free cyanide), fluoride, mercury, nickel, selenium, and thallium. Monitoring to determine compliance with the PMCL for these contaminants specified in Table 340.1 shall be conducted as follows:

a. The owner shall collect one sample at each groundwater source entry point during each compliance period.

b. The owner shall collect one sample annually at each surface water source entry point, in whole or in part.

c. The owner may apply to the department for a waiver from the monitoring frequencies specified in subdivisions D 2 a and D 2 b of this section.

(1) A condition of the waiver shall require that the owner collect a minimum of one sample while the waiver is effective. The waiver remains in effect for one compliance cycle (i.e., nine years).

(2) The department may grant a waiver provided the owner has monitored surface water source entry points, in whole or in part, annually for at least three years and has conducted a minimum of three rounds of monitoring at groundwater source entry points. At least one sample shall have been collected since January 1, 1990. The owner shall demonstrate that all previous analytical results were less than the PMCL. A waterworks that uses a new groundwater or surface water source is not eligible for a waiver until three rounds of monitoring from the new source have been completed.

(3) In determining the appropriate reduced monitoring frequency, the department shall consider:

(a) The reported concentrations from all previous monitoring;

(b) The degree of variation in reported concentrations; and

(c) Other factors that may affect contaminant concentrations such as changes in groundwater pumping rates, changes in the waterworks configuration, changes in the waterworks operating procedures, or changes in stream flows or characteristics.

(4) A decision by the department to grant a waiver shall be made in writing and shall set forth the basis for the determination. The request for a waiver may be initiated by the department or upon an application by the owner. The owner shall specify the basis for the request. The department shall evaluate and, where appropriate, revise the determination of the appropriate monitoring frequency when the owner submits new monitoring data or when other data relevant to the appropriate monitoring frequency become available.

(5) No arsenic waivers shall be granted by the department.

d. The owner of a waterworks that exceed the PMCLs as calculated in 12VAC5-590-382 shall monitor quarterly beginning in the next quarter after the exceedance occurred. The department may decrease the quarterly monitoring requirement to the frequencies specified in subdivision D 2 a, D 2 b, or D 2 c of this section provided a determination has been made that the analytical results are reliably and consistently below the PMCL. In no case may the department make this determination unless the owner collects a minimum of two quarterly samples from each groundwater source entry point and a minimum of four quarterly samples from each surface water source entry point, in whole or in part.

3. Nitrate and combined nitrate-nitrite as nitrogen. Monitoring to determine compliance with the PMCL for nitrate and combined nitrate-nitrite as nitrogen specified in Table 340.1 shall be conducted as follows:

a. The owner shall collect one sample annually at each groundwater source entry point.

b. The owner shall collect one sample quarterly at each surface water source entry point, in whole or in part.

c. For groundwater source entry points at community and NTNCs, the repeat monitoring frequency shall be quarterly for at least one year following any one sample in which the concentration is greater than 50% of the PMCL. After four consecutive quarters of monitoring, the department may allow the owner to reduce the sampling frequency to annually after determining the results are reliably and consistently less than the PMCL.

d. For surface water source entry points, in whole or in part, the department may allow the owner to reduce the sampling frequency to annually if all analytical results from four consecutive quarters are less than 50% of the PMCL. The waterworks shall return to quarterly monitoring if the concentration found in any one sample is greater than or equal to 50% of the PMCL.

e. After any round of quarterly sampling is completed as required by subdivisions D 3 c and D 3 d of this section, the owner who is monitoring annually shall collect subsequent samples during the quarter that previously resulted in the highest analytical result.

f. No monitoring waivers shall be issued for nitrate or combined nitrate-nitrite as nitrogen.

4. Nitrite. Monitoring to determine compliance with the PMCL for nitrite specified in Table 340.1 shall be conducted as follows:

a. The owner shall collect one sample at each entry point during the initial compliance period.

b. After the initial sample, the owner of a waterworks where an analytical result for nitrite is less than 50% of the PMCL shall monitor at the frequency specified by the department.

c. The repeat monitoring frequency for an owner shall be quarterly for at least one year following any one sample in which the concentration is greater than 50% of the PMCL. The department may allow an owner to reduce the sampling frequency to annually after determining the analysis results are reliably and consistently less than the PMCL.

d. The owner of a waterworks that is monitoring annually shall collect each subsequent sample during the quarter that previously resulted in the highest analytical result.

e. No monitoring waivers shall be issued for nitrite.

5. Aluminum, chloride, copper, corrosivity, fluoride, foaming agents (surfactants), iron, manganese, silver, sulfate, and zinc. Monitoring to determine compliance with the SMCL for these contaminants specified in Table 340.1 shall be conducted as follows:

a. The owner shall collect one sample at each groundwater source entry point during each compliance period.

b. The owner shall collect one sample annually at each surface water source entry point, in whole or in part.

6. Sodium. All community waterworks shall monitor for sodium as follows:

a. The number of samples to be collected shall be determined by the department based on the waterworks infrastructure and occurrence concentrations where applicable.

(1) The owner shall collect at least one sample annually at each surface water source entry point, in whole or in part.

(2) The owner shall collect one sample at each groundwater source entry point at least every three years.

(3) The department may require the owner to collect and analyze water samples for sodium more frequently where sodium content is variable.

b. Sodium shall be analyzed in accordance with methods and laboratory requirements identified in 12VAC5-590-440.

c. Sample results shall be submitted to the department in accordance with 12VAC5-590-530.

d. The department shall notify local and state health officials of the sodium levels.

e. The results of the special monitoring for sodium shall be included in the Consumer Confidence Report in accordance with 12VAC5-590-545 C 5 f.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-373 Organic chemicals monitoring

A. The owner of a community waterworks or a NTNC shall conduct monitoring to determine compliance with PMCLs listed in Table 340.2 in accordance with this section. Where two or more sources are combined before distribution, the owner shall sample at the entry point for the combined sources during periods of normal operation conditions.

1. The owner of a waterworks that uses groundwater shall collect a minimum of one sample at each entry point.

2. The owner of a waterworks that uses surface water, in whole or in part, shall collect a minimum of one sample at each entry point.

B. During the initial compliance period and each subsequent compliance period, the owner shall monitor during four consecutive calendar quarters for each contaminant listed in Table 340.2. A minimum of one sample at each entry point shall be collected during each calendar quarter.

C. Reduced monitoring.

1. Volatile organic chemicals (VOCs).

a. The requirement for four quarterly samples during initial monitoring as specified in subsection Bof this section may not be reduced.

b. The department may decrease the requirement for quarterly monitoring during subsequent compliance periods provided it has been determined that the analytical results are reliably and consistently below the PMCL. In no case shall the department make this determination unless:

(1) The owner collects a minimum of two quarterly samples at each groundwater source entry point; or

(2) The owner collects a minimum of four quarterly samples at each surface water source entry point, in whole or in part.

c. If the department determines that the waterworks is reliably and consistently below the PMCL, then the department may allow the owner to monitor annually. The owner who monitors annually shall monitor during the quarter that previously yielded the highest analytical result.

d. For a groundwater system only. After a minimum of three years of annual sampling, the department may allow the owner with no previous detection of any VOCs listed in Table 340.2 to collect one sample during each compliance period.

e. The owner of a groundwater system that has three consecutive annual samples with no detection of a contaminant may apply to the department for a waiver, in accordance with 12VAC5-590-373 F.

2. Synthetic organic chemicals (SOCs).

a. The owner of a waterworks serving more than 3,300 persons that does not detect any SOCs listed in Table 340.2 in the initial compliance period may reduce the sampling frequency to a minimum of two quarterly samples in one year during each repeat compliance period.

b. The owner of a waterworks serving fewer than or equal to 3,300 persons that does not detect any SOCs listed in Table 340.2 in the initial compliance period may reduce the sampling frequency to a minimum of one sample during each repeat compliance period.

c. The department may reduce the quarterly monitoring required by subdivision B or D of this section provided the department has determined that the analytical results are reliably and consistently below the PMCL. In no case shall the department make this latter determination unless:

(1) The owner collects a minimum of two quarterly samples at each groundwater source entry point.

(2) The owner collects a minimum of four quarterly samples at each surface water source entry point, in whole or in part.

d. If the department determines that the analytical results are reliably and consistently below the PMCL, the department may allow the owner to monitor annually. The owner of a waterworks that monitors annually shall monitor during the quarter that previously yielded the highest analytical result.

e. The owner of a waterworks that has three consecutive annual samples with no detection of a contaminant may apply to the department for a waiver for SOC monitoring by submitting a waiver application as specified in subdivisions F 1 b and F 2 b of this section. The waiver remains in effect for one compliance period (i.e., three years).

D. Increased monitoring.

1. If the owner of a waterworks that is on reduced monitoring detects a contaminant listed in Table 340.2 (see 12VAC5-590-383 A regarding confirmation samples), then the owner shall monitor quarterly at each sampling point where the contaminant was detected unless:

a. That contaminant was previously detected and the department determined it was reliably and consistently below the PMCL according to subdivisions C 1 b and C 2 c of this section;

b. The historical sampling data do not indicate a meaningful increase in the contaminant concentration; and

c. The contaminant concentration does not exceed the PMCL.

2. The owner of a waterworks that exceeds the PMCLs listed in Table 340.2 for VOCs or SOCs, as determined by 12VAC5-590-383, shall monitor quarterly.

a. If, after a minimum of four consecutive quarterly samples that show the waterworks is in compliance as specified in 12VAC5-590-383; and

b. The department determines that the analytical results are reliably and consistently below the PMCL; then

c. The owner may monitor at the frequency and time specified in subdivisions C 1 c and C 2 d of this section.

E. Other monitoring requirements.

1. Vinyl chloride.

a. The owner of a groundwater system that has detected one or more of the following two-carbon organic compounds: trichloroethylene, tetrachloroethylene, 1,2-dichloroethane, 1,1,1-trichloroethane, cis-1,2-dichloroethylene, trans-1,2-dichloroethylene, or 1,1-dichloroethylene, shall monitor quarterly for vinyl chloride. A vinyl chloride sample shall be collected at each sampling point at which one or more of the two-carbon organic compounds were detected. If the results of the first analysis do not detect vinyl chloride, then the department may reduce the quarterly monitoring frequency of vinyl chloride monitoring to one sample during each compliance period.

b. The owner of a waterworks that uses surface water in whole or in part is required to monitor for vinyl chloride as specified by the department.

2. If monitoring detects one or more of certain related contaminants (heptachlor and heptachlor epoxide), then subsequent monitoring shall analyze for all related contaminants.

3. For entry points sampled and analyzed for contaminants listed in Table 340.2, the following detection limits apply:

a. A VOC is detected at a level equal to or greater than 0.0005 mg/L; and

b. A SOC is detected at a level equal to or greater than defined by EPA under 40 CFR 141.24(h)(18) or by the department.

F. Monitoring waivers.

1. Groundwater source entry points.

a. The owner of a waterworks that does not detect a VOC contaminant listed in Table 340.2 may apply to the department for a waiver from the subsequent compliance period requirements of subsection B and subdivision C 1 c of this section after completing the initial monitoring. A waiver shall be effective for no more two compliance periods (i.e., six years).

b. The owner of a waterworks may apply to the department for a SOC monitoring waiver from the requirements of subsection B and subdivision C 2 of this section. The owner must reapply for a waiver for each subsequent compliance period (i.e., three years).

2. Surface water source entry points, in whole or in part.

a. No VOC monitoring waivers shall be issued.

b. The owner of a waterworks that does not detect a SOC contaminant listed in Table 340.2 may apply to the department for a SOC monitoring waiver from the requirements of subsection B and subdivision C 2 of this section. The owner must reapply for a waiver for each subsequent compliance period (i.e., three years).

3. Monitoring waiver applications. The owner shall submit a monitoring waiver application for evaluation on a form approved by the department. The department may grant a waiver after an evaluation of the use, transport, storage, or disposal of any organic contaminant within the watershed or zone of influence of the source.

a. If an evaluation by the department reveals no previous use of the contaminants within the watershed or zone of influence, then a waiver may be granted.

b. If an evaluation by the department reveals either previous use of the contaminants or that use is unknown, then the following factors shall be used to determine whether a waiver is granted:

(1) Previous analytical results.

(2) The proximity of the source water to land use activities that are potential point or nonpoint sources of organic contamination and to potential conduits to groundwater. Point sources include spills and leaks of chemicals at or near a waterworks or at manufacturing, distribution, or storage facilities or from hazardous or municipal waste landfills and other waste handling or treatment facilities. Nonpoint sources for SOCs include the use of pesticides to control insects and weed pests on agricultural areas, forest lands, home and gardens, and other land application uses.

(3) The environmental persistence and transport of the contaminants listed in Table 340.2.

(4) The implementation of a watershed protection program for surface water systems and wellhead protection measures for groundwater systems by the owner.

(5) For groundwater well sources: well construction, well depth, soil type, geological conditions, and well structure integrity.

(6) Special factors, as follows:

(a) For VOCs, the number of persons served by the waterworks and the proximity of a smaller waterworks to a larger waterworks.

(b) For SOCs, elevated nitrate levels at the waterworks' source water.

(c) For SOCs, use of PCBs in equipment used in the production, storage, or distribution of water (i.e., PCBs used in pumps, transformers, and other equipment).

c. An entry point at which treatment has been installed to remove VOCs or SOCs is not eligible for a monitoring waiver for the VOCs or SOCs for which treatment has been installed.

d. All waterworks are granted a waiver from monitoring dioxin, endothall, and glyphosate unless the department determines that there is a source of these contaminants that poses a threat to the source water.

4. Condition for waivers.

a. Groundwater source entry points.

(1) As a condition of the VOC waiver, the owner shall collect one sample at each entry point during the time the waiver is effective (i.e., one sample during two compliance periods or six years) and update the waterworks vulnerability assessment. Based on this data, the department may reconfirm that the source is nonvulnerable. If the department does not make this reconfirmation within three years of the initial determination, then the waiver is invalidated and the owner is required to sample annually.

(2) There are no conditions to SOC waivers.

b. Surface water source entry points, in whole or in part. There are no conditions to VOC and SOC waivers for waterworks in regard to these entry points.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-374 Residual disinfectant, disinfection byproducts, and disinfection byproduct precursors monitoring

A. Unless otherwise noted, an owner of a waterworks that uses a chemical disinfectant shall comply with the requirements of this section as follows:

1. The owner of a community waterworks or a NTNC shall comply with this section.

2. The owner of a TNC that uses any combination of a surface water source, a GUDI source, or a groundwater source and uses chlorine dioxide as a disinfectant or oxidant shall comply with all the requirements for chlorine dioxide in this section.

B. The owner shall collect all samples during normal operating conditions.

1. Analysis under this section for DBPs (TTHM, HAA5, chlorite, and bromate) shall be conducted by laboratories that have received certification by EPA or DCLS as specified in 12VAC5-590-440, except as noted in subdivisions B 2 and B 3 of this section.

2. Measurement under this section of daily chlorite samples at the entry point to the distribution system, residual disinfectant (free chlorine, combined chlorine, total chlorine, and chlorine dioxide), alkalinity, bromide, TOC, SUVA (DOC and UV₂₅₄), pH, and magnesium shall be made by a party approved by the department.

3. Residual disinfectant concentrations for free chlorine, combined chlorine, total chlorine, and chlorine dioxide shall be made using equipment deemed satisfactory by the department.

C. Monitoring plan. The owner required to monitor under this section shall develop and implement a monitoring plan. The owner shall maintain the plan and make it available for inspection by the department and the general public. The owner of a community waterworks or a NTNC that uses a surface water source, a GUDI source, or both and serves more than 3,300 people shall submit a copy of the monitoring plan to the department no later than the date of the first report required under 12VAC5-590-531 A. The department may also require the plan to be submitted by any other owner. After evaluation, the department may require changes in any of the plan elements. The plan shall include at least the following:

1. Specific locations and schedules with monitoring dates for collecting samples for any parameters included in this section.

2. How the owner will calculate compliance with PMCLs, MRDLs, and treatment techniques.

3. The sampling plan for a consecutive waterworks shall reflect the entire consecutive distribution system.

4. All new waterworks shall comply with the monitoring location requirements of 40 CFR 141 Subpart U, Initial distribution system evaluations, in the development of the waterworks monitoring plan.

D. Failure to monitor in accordance with the monitoring plan required under subsection C of this section is a monitoring violation. Failure to monitor shall be treated as a violation for the entire period covered by the annual average where compliance is based on an RAA of monthly or quarterly samples or averages, and the owner's failure to monitor makes it impossible to determine compliance with PMCLs or MRDLs.

E. The owner may use only data collected under the provisions of this section to qualify for reduced monitoring.

F. TTHM and HAA5 monitoring. The owner of a community waterworks or a NTNC shall conduct the LRAA monitoring for TTHM and HAA5 at the frequency given below, unless otherwise indicated.

1. This subdivision establishes monitoring and other requirements for achieving compliance with PMCLs based on the LRAA for TTHM and HAA5, and for achieving compliance with MRDLs for chlorine and chloramines for certain consecutive waterworks.

2. This subdivision applies to a community waterworks or a NTNC that uses a primary or secondary disinfectant other than UV light or delivers water that has been treated with a primary or secondary disinfectant other than UV light.

3. Routine monitoring.

a. If the waterworks is a NTNC serving fewer than 10,000 people, then the owner shall monitor at the location or locations and dates identified in the monitoring plan in subsection C of this section, updated as required by subdivision F 3 e of this section.

b. The owner shall monitor at no fewer than the number of locations identified in Table 374.1:

| TABLE 374.1 Monitoring Frequency by Source Water Type for TTHM and HAA5 | | | | | --- | --- | --- | --- | | SOURCE WATER TYPE | POPULATION SIZE CATEGORY | MONITORING FREQUENCY^a | DISTRIBUTION SYSTEM MONITORING LOCATION TOTAL PER MONITORING PERIOD^b | | Surface water or GUDI Source | Less than 500 | per year | 2 | | 500 - 3,300 | per quarter | 2 | | | 3,301 - 9,999 | per quarter | 2 | | | 10,000 - 49,999 | per quarter | 4 | | | 50,000 - 249,999 | per quarter | 8 | | | 250,000 - 999,999 | per quarter | 12 | | | 1,000,000 - 4,999,999 | per quarter | 16 | | | Equal to or greater than 5,000,000 | per quarter | 20 | | | Groundwater | Less than 500 | per year | 2 | | 500 - 9,999 | per year | 2 | | | 10,000 - 99,999 | per quarter | 4 | | | 100,000 - 499,999 | per quarter | 6 | | | Equal to or greater than 500,000 | per quarter | 8 | | | ^aThe owner shall monitor during the month of highest DBP concentrations. ^bThe owner of a waterworks on quarterly monitoring (except those using a surface water source, a GUDI source, or both and serving 500 to 3,300 people) shall collect dual sample sets every 90 days at each monitoring location. A groundwater system serving 500 to 9,999 people shall collect dual sample sets annually at each monitoring location. A waterworks serving fewer than 500 people and a waterworks using a surface water source, a GUDI source, or both and serving 500 to 3,300 people shall collect individual TTHM and HAA5 samples (instead of a dual sample set) at the locations with the highest TTHM and HAA5 concentrations, respectively. A waterworks serving fewer than 500 people shall sample annually, and a waterworks using a surface water source, a GUDI source, or both and serving 500 to 3,300 people shall sample every 90 days. For a waterworks serving fewer than 500 people, only one location with a dual sample set per monitoring period is needed if the highest TTHM and HAA5 concentrations occur at the same location (and month, if monitoring annually). | | | |

c. The owner of a waterworks not using disinfection that then begins using a disinfectant other than UV light shall consult with the department to identify compliance monitoring locations. The owner shall develop a monitoring plan under subdivision F 3 e of this section to include those monitoring locations.

d. The owner shall use an approved method listed in 12VAC5-590-440 for TTHM and HAA5 analyses. Analyses shall be conducted by laboratories that have received certification by EPA or DCLS as specified in 12VAC5-590-440.

e. The owner may revise the monitoring plan to reflect changes in treatment, distribution system operations and layout (including new service areas), or other factors that may affect TTHM or HAA5 formation, or for reasons approved by the department after consultation with the department regarding the need for changes and the appropriateness of the changes. If the owner changes monitoring locations, then the owner shall replace existing compliance monitoring locations with the lowest LRAA with new locations that reflect the current distribution system locations with expected high TTHM or HAA5 levels. The department may also require modifications in the monitoring plan. The owner of a waterworks using a surface water source, a GUDI source, or both and serving more than 3,300 people shall submit a copy of the modified monitoring plan to the department before the date the owner is required to comply with the revised monitoring plan.

4. Reduced monitoring.

a. The owner may reduce monitoring to the level specified in Table 374.2 any time the LRAA is less than or equal to 0.040 mg/L for TTHM and less than or equal to 0.030 mg/L for HAA5 at all monitoring locations. The owner may only use data collected under the provisions of this section to qualify for reduced monitoring. In addition, the source water annual average TOC level, before any treatment, shall be less than or equal to 4.0 mg/L at each water treatment plant treating a surface water source, a GUDI source, or both based on monitoring conducted under subsection J of this section.

| TABLE 374.2 Reduced Monitoring for TTHM and HAA5 | | | | | --- | --- | --- | --- | | SOURCE WATER TYPE | POPULATION SIZE CATEGORY | MONITORING FREQUENCY^a | DISTRIBUTION SYSTEM MONITORING LOCATION PER MONITORING PERIOD | | Surface water or GUDI Source | Less than 500 | | Monitoring may not be reduced. | | 500 - 3,300 | per year | One TTHM and one HAA5 sample: one at the location and during the quarter with the highest TTHM single measurement, one at the location and during the quarter with the highest HAA5 single measurement; one dual sample set per year if the highest TTHM and HAA5 measurements occurred at the same location and quarter. | | | 3,301 - 9,999 | per year | Two dual sample sets: one at the location and during the quarter with the highest TTHM single measurement, one at the location and during the quarter with the highest HAA5 single measurement. | | | 10,000 - 49,999 | per quarter | Two dual sample sets: at the locations with the highest TTHM and highest HAA5 LRAAs. | | | 50,000 - 249,999 | per quarter | Four dual sample sets: at the locations with the two highest TTHM and two highest HAA5 LRAAs. | | | 250,000 - 999,999 | per quarter | Six dual sample sets: at the locations with the three highest TTHM and three highest HAA5 LRAAs. | | | 1,000,000 - 4,999,999 | per quarter | Eight dual sample sets: at the locations with the four highest TTHM and four highest HAA5 LRAAs. | | | Equal to or greater than 5,000,000 | per quarter | Ten dual sample sets: at the locations with the five highest TTHM and five highest HAA5 LRAAs. | | | Groundwater | Less than 500 | every third year | One TTHM and one HAA5 sample: one at the location and during the quarter with the highest TTHM single measurement, one at the location and during the quarter with the highest HAA5 single measurement; one dual sample set per year if the highest TTHM and HAA5 measurements occurred at the same location and quarter. | | 500 - 9,999 | per year | One TTHM and one HAA5 sample: one at the location and during the quarter with the highest TTHM single measurement, one at the location and during the quarter with the highest HAA5 single measurement; one dual sample set per year if the highest TTHM and HAA5 measurements occurred at the same location and quarter. | | | 10,000 - 99,999 | per year | Two dual sample sets: one at the location and during the quarter with the highest TTHM single measurement, one at the location and during the quarter with the highest HAA5 single measurement. | | | 100,000 - 499,999 | per quarter | Two dual sample sets: at the locations with the highest TTHM and highest HAA5 LRAAs. | | | Equal to or greater than 500,000 | per quarter | Four dual sample sets: at the locations with the two highest TTHM and two highest HAA5 LRAAs. | | | ^aThe owner of a waterworks on quarterly monitoring shall collect dual sample sets every 90 days. | | | |

b. The owner may remain on reduced monitoring as long as the TTHM LRAA is less than or equal to 0.040 mg/L and the HAA5 LRAA is less than or equal to 0.030 mg/L at each monitoring location (for waterworks with quarterly reduced monitoring) or each TTHM sample is less than or equal to 0.060 mg/L and each HAA5 sample is less than or equal to 0.045 mg/L (for waterworks with annual or less frequent monitoring). In addition, the source water annual average TOC level, before any treatment, shall be less than or equal to 4.0 mg/L at each water treatment plant treating a surface water source or a GUDI source, based on monitoring conducted under subsection J of this section.

c. If the LRAA based on quarterly monitoring at any monitoring location exceeds either 0.040 mg/L for TTHM or 0.030 mg/L for HAA5 or if the annual (or less frequent) sample at any location exceeds either 0.060 mg/L for TTHM or 0.045 mg/L for HAA5, or if the source water annual average TOC level, before any treatment, is greater than 4.0 mg/L at any water treatment plant treating a surface water source, a GUDI source, or both then the owner shall resume routine monitoring under subdivision F 3 of this section or begin increased monitoring if subdivision F 5 of this section applies.

d. A waterworks may return to routine monitoring at the department's discretion.

5. Increased monitoring.

a. The owner of a waterworks required to monitor at a particular location annually or less frequently than annually under subdivision F 3 or F 4 of this section, shall increase monitoring to dual sample sets once per quarter (collected every 90 days) at all locations if a TTHM sample is greater than 0.080 mg/L or a HAA5 sample is greater than 0.060 mg/L at any location.

b. The owner may return to routine monitoring once the waterworks has conducted increased monitoring for at least four consecutive quarters and the LRAA for every monitoring location is less than or equal to 0.060 mg/L for TTHM and less than or equal to 0.045 mg/L for HAA5.

G. Chlorite. The owner of a community waterworks or a NTNC using chlorine dioxide, for disinfection or oxidation, shall conduct monitoring for chlorite.

1. Routine monitoring.

a. The owner shall collect daily samples at the entry point to the distribution system. For any daily sample that exceeds the chlorite PMCL listed in Table 340.6, the owner shall collect additional samples in the distribution system the following day at the locations required by subdivision G 1 c of this section, in addition to the sample required at the entrance to the distribution system.

b. The owner shall collect a three-sample set each month in the distribution system. The owner shall collect one sample at each of the following locations: near the first customer, at a location representative of average residence time, and at a location reflecting maximum residence time in the distribution system. Any additional routine sampling shall be conducted in the same manner (as three-sample sets, at the specified locations). The owner may use the results of additional monitoring conducted under subdivision G 1 c of this section to meet the requirement for monitoring in this subdivision G 1 b.

c. On each day following a routine sample monitoring result that exceeds the chlorite PMCL listed in Table 340.6 at the entrance to the distribution system, the owner is required to collect three chlorite distribution system samples at the following locations: as close to the first customer as possible, in a location representative of average residence time, and as close to the end of the distribution system as possible (reflecting maximum residence time in the distribution system).

2. Reduced monitoring.

a. Chlorite monitoring at the entrance to the distribution system required by subdivision G 1 a of this subsection may not be reduced.

b. Chlorite monitoring in the distribution system required by subdivision G 1 b of this section may be reduced to one three-sample set per quarter after one year of monitoring where no individual chlorite sample collected in the distribution system under subdivision G 1 b of this section has exceeded the chlorite PMCL listed in Table 340.6 and the owner has not been required to conduct monitoring under subdivision G 1 c of this section. The owner may remain on the reduced monitoring schedule until either any of the three individual chlorite samples collected quarterly in the distribution system under subdivision G 1 b of this section exceeds the chlorite PMCL or the owner is required to conduct monitoring under subdivision G 1 c of this section, at which time the owner shall revert to routine monitoring.

H. Bromate.

1. The owner of a community waterworks or a NTNC water treatment plant using ozone for disinfection or oxidation shall collect one sample per month and analyze it for bromate. The owner shall collect samples monthly at the entrance to the distribution system while the ozonation system is operating under normal conditions.

2. The owner required to analyze for bromate may reduce monitoring from monthly to quarterly if the waterworks RAA bromate concentration is less than or equal to 0.0025 mg/L based on monthly bromate measurements under subdivision H 1 of this section for the most recent four quarters. If a waterworks has qualified for reduced bromate monitoring under this subdivision, then the owner may remain on reduced monitoring as long as the RAA of quarterly bromate samples is equal to or less than 0.0025 mg/L. If the RAA bromate concentration is greater than 0.0025 mg/L, then the owner shall resume routine monitoring required by subdivision H 1 of this section.

I. Monitoring requirements for the residual disinfectant.

1. Chlorine and chloramines.

a. The owner of a waterworks that uses chlorine or chloramines shall measure the residual disinfectant level in the distribution system at the same point in the distribution system and at the same time as total coliform bacteria are sampled, as specified in 12VAC5-590-370 A and 12VAC5-590-380 D. The owner of a waterworks using a surface water source, a GUDI source, or both may use the results of the residual disinfectant concentration sampling found in 12VAC5-590-376 D instead of collecting separate samples.

b. Residual disinfectant level monitoring may not be reduced.

2. Chlorine dioxide.

a. The owner of a waterworks that uses chlorine dioxide for disinfection or oxidation shall collect daily samples at the entrance to the distribution system. For any daily sample that exceeds the MRDL listed in Table 340.7, the owner shall collect samples in the distribution system the following day at the locations required by subdivision I 2 b of this section, in addition to the sample required at the entrance to the distribution system.

b. On each day following a routine sample monitoring result that exceeds the MRDL listed in Table 340.7, the owner is required to collect three chlorine dioxide distribution system samples. If chlorine dioxide or chloramines are used to maintain a residual disinfectant in the distribution system, or if chlorine is used to maintain a residual disinfectant in the distribution system and there is no rechlorination after the entry point, then the owner shall collect three samples as close to the first customer as possible, at intervals of at least six hours. If chlorine is used to maintain a residual disinfectant in the distribution system and there are one or more rechlorination points after the entry point, then the owner shall collect one sample at each of the following locations: as close to the first customer as possible, in a location representative of average residence time, and as close to the end of the distribution system as possible (reflecting maximum residence time in the distribution system).

c. Chlorine dioxide monitoring may not be reduced.

3. Ozone. Ozone residual levels shall be monitored continuously and recorded. A portable ozone meter is recommended as a backup.

4. Additional monitoring and reporting requirements are specified in 12VAC5-590-500 to demonstrate log inactivation or removal of Giardia lamblia, virus, and Cryptosporidium.

J. Monitoring requirements for DBPPs.

1. The owner of a community waterworks or a NTNC using a surface water source, a GUDI source, or both and using conventional filtration treatment, as defined in 12VAC5-590-10, shall monitor each water treatment plant for TOC no later than the point of CFE turbidity monitoring and representative of the treated water. The owner shall also monitor for TOC in the source water before any treatment at the same time as monitoring for TOC in the treated water. These samples (source water and treated water) are referred to as paired samples. At the same time as the source water sample is collected, the owner shall monitor for alkalinity in the source water before any treatment. The owner shall collect one paired sample and one source water alkalinity sample per month per water treatment plant at a time representative of normal operating conditions and influent water quality.

2. The owner of a community waterworks or a NTNC that uses a surface water source, a GUDI source, or both with an average treated water TOC of less than 2.0 mg/L for two consecutive years, or less than 1.0 mg/L for one year, may reduce monitoring for both TOC and alkalinity to one paired sample and one source water alkalinity sample per water treatment plant per quarter. The owner shall revert to routine monitoring in the month following the quarter when the annual average treated water TOC is equal to or greater than 2.0 mg/L.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-375 Lead and copper monitoring

A. The owner of a community waterworks or a NTNC shall monitor for lead and copper in tap water (subsection B of this section), water quality (corrosion) parameters in the distribution system and at entry points (subsection C of this section), and lead and copper in water supplies (subsection D of this section).

B. Monitoring requirements for lead and copper in tap water.

1. Sample site location.

a. By the date determined by the department for commencement of monitoring under subdivision B 4 a of this section, the owner shall complete a materials evaluation of the distribution system to identify a pool of targeted sampling sites that meets the requirements of this subdivision, and that is sufficiently large to ensure that the owner can collect the number of lead and copper tap samples required in subdivision B 3 of this section. All sites from which first-draw samples are collected shall be selected from this pool of targeted sampling sites. Sampling sites may not include faucets that have POU devices or POE devices designed to remove inorganic contaminants.

b. When the distribution system evaluation required in subdivision B 1 a of this section is insufficient to locate the requisite number of lead and copper sampling sites that meet the targeting criteria of this section, the owner shall review the sources of information listed in subdivisions B 1 b (1), B 1 b (2), and B 1 b (3) of this section to identify a sufficient number of sampling sites. In addition, the owner shall seek to collect such information where possible in the course of its normal operations (e.g., checking service line materials when reading water meters or performing maintenance activities):

(1) All plumbing codes, permits, and records in the files of the building department that indicate the plumbing materials that are installed within publicly and privately owned structures connected to the distribution system;

(2) All inspections and records of the distribution system that indicate the material composition of the service connections that connect a structure to the distribution system; and

(3) All existing water quality information, which includes the results of all prior analyses of the waterworks or individual structures connected to the waterworks, indicating locations that may be particularly susceptible to high lead or copper concentrations.

c. The sampling sites selected for a community waterworks' sampling pool (Tier 1 sampling sites) shall consist of single-family structures that:

(1) Contain copper pipes with lead solder installed between January 1983 and April 1986 or contain lead pipes; or

(2) Are served by a lead service line.

When multiple-family residences comprise at least 20% of the structures served by a waterworks, the owner may include these types of structures in the sampling pool.

d. The owner of a community waterworks with insufficient Tier 1 sampling sites shall complete the sampling pool with Tier 2 sampling sites consisting of buildings, including multiple-family residences that:

(1) Contain copper pipes with lead solder installed between January 1983 and April 1986 or contain lead pipes; or

(2) Are served by a lead service line.

e. The owner of a community waterworks with insufficient Tier 1 and Tier 2 sampling sites shall complete the sampling pool with Tier 3 sampling sites, consisting of single family structures that contain copper pipes with lead solder installed before 1983. The owner of a community waterworks with insufficient Tier 1, Tier 2, and Tier 3 sampling sites shall complete the sampling pool with representative sites throughout the distribution system. For the purpose of this subdivision, a representative site is a site in which the plumbing materials used at that site would be commonly found at other sites served by the waterworks.

f. The sampling sites selected for a NTNC (Tier 1 sampling sites) shall consist of buildings that:

(1) Contain copper pipes with lead solder installed between January 1983 and April 1986 or contain lead pipes; or

(2) Are served by a lead service line.

g. The owner of a NTNC with insufficient Tier 1 sites that meet the targeting criteria in subdivision B 1 f of this section shall complete the sampling pool with sampling sites that contain copper pipes with lead solder installed before 1983. If additional sites are needed to complete the sampling pool, the owner of a NTNC shall use representative sites throughout the distribution system. For the purpose of this subdivision, a representative site is a site in which the plumbing materials used at that site would be commonly found at other sites served by the waterworks.

h. The owner of a waterworks whose distribution system contains lead service lines shall draw 50% of the samples the owner collects during each monitoring period from sites that contain lead pipes, or copper pipes with lead solder, and 50% of the samples the owner collects from sites served by a lead service line. The owner who cannot identify a sufficient number of sampling sites served by a lead service line shall collect first-draw tap samples from all of the sites identified as being served by these lines.

2. Sample collection methods.

a. All tap samples for lead and copper, with the exception of lead service line samples collected under 12VAC5-590-405 C 4 and samples collected under subdivision B 2 e of this section, shall be first-draw samples.

b. Each first-draw tap sample for lead and copper shall be one liter in volume, have stood motionless in the plumbing system of each sampling site for at least six hours, and have been collected without flushing the tap. First-draw samples from residential housing shall be collected from the cold-water kitchen tap or from a bathroom sink tap. First-draw samples from a nonresidential building shall be one liter in volume and shall be collected at an interior tap from which water is typically drawn for consumption. Non-first-draw samples collected instead of first-draw samples pursuant to subdivision B 2 e of this section shall be one liter in volume and shall be collected at an interior tap from which water is typically drawn for consumption. First-draw samples may be collected by the owner or the owner may allow residents to collect first-draw samples after instructing the residents of the sampling procedures specified in this subdivision. To avoid problems of residents handling nitric acid, acidification of first-draw samples may be done up to 14 days after the sample is collected. After acidification to resolubilize the metals, the sample must stand in the original container for the time specified in the approved EPA method before the sample can be analyzed. If an owner allows residents to perform sampling, then the owner may not challenge, based on alleged errors in sample collection, the accuracy of sampling results.

c. Each lead service line sample collected pursuant to 12VAC5-590-405 C 4 for the purpose of avoiding replacement shall be one liter in volume and have stood motionless in the lead service line for at least six hours. Lead service line samples shall be collected in one of the following three ways:

(1) At the tap after flushing the volume of water between the tap and the lead service line. The volume of water shall be calculated based on the interior diameter and length of the pipe between the tap and the lead service line;

(2) Tapping directly into the lead service line; or

(3) If the sampling site is a building constructed as a single-family residence, then allowing the water to run until there is a significant change in temperature that would be indicative of water that has been standing in the lead service line.

d. The owner shall collect each first-draw tap sample from the same sampling site from which the owner collected a previous sample. If, for any reason, the owner cannot gain entry to a sampling site to collect a follow-up tap sample, then the owner may collect the follow-up tap sample from another sampling site in the sampling pool as long as the new site meets the same targeting criteria and is within reasonable proximity of the original site.

e. The owner of a NTNC, or a community waterworks that meets the criteria of 12VAC5-590-405 D 2 e (2) that does not have enough taps that can supply first-draw samples, as defined in subdivision B 2 b of this section, may apply to the department in writing to substitute non-first-draw samples. If approved by the department, then an owner shall collect as many first-draw samples from appropriate taps as possible and identify sampling times and locations that would likely result in the longest standing time for the remaining sites.

3. Number of samples.

a. The owner shall collect at least one sample during each monitoring period specified in subdivision B 4 of this section from the number of sites listed in the first column (standard monitoring) of Table 375.1. The owner of a waterworks conducting reduced monitoring under subdivision B 4 d of this section shall collect at least one sample from the number of sites specified in the second column (reduced monitoring) of Table 375.1 during each monitoring period specified in subdivision B 4 d of this section. Reduced monitoring sites shall be representative of the sites required for standard monitoring. The department may specify sampling locations when an owner is conducting reduced monitoring.

b. The owner of a waterworks that has fewer than five drinking water taps that are normally used for human consumption meeting the sample site criteria of subdivision B 1 of this section to reach the required number of sample sites listed in Table 375.1 shall collect at least one sample from each tap and then shall collect additional samples from those taps on different days during the monitoring period to meet the required number of sites. Alternatively, the department may allow the owner to collect a number of samples less than the number of sites specified in Table 375.1, provided that 100% of all taps that are normally used for human consumption are sampled. The department shall approve this reduction of the minimum number of samples in writing based on a request from the owner or onsite verification by the designated department representative.

c. The lead and copper tap sample table is as follows:

| TABLE 375.1 Tap Samples for Lead and Copper | | | | --- | --- | --- | | WATERWORKS SIZE (Number of People Served) | NUMBER OF SITES (Standard Monitoring) | NUMBER OF SITES (Reduced Monitoring) | | Greater than 100,000 | 100 | 50 | | 10,001-100,000 | 60 | 30 | | 3,301 to 10,000 | 40 | 20 | | 501 to 3,300 | 20 | 10 | | 101 to 500 | 10 | 5 | | Less than or equal to 100 | 5 | 5 |

4. Timing of monitoring.

a. Initial tap sampling. The first six-month monitoring period for small (serving less than 3,300 population), medium (serving 3,301 to 50,000 population), and large waterworks (serving greater than 50,000 population) shall be established by the department.

(1) The owner of a large waterworks shall monitor during two consecutive six-month periods.

(2) The owner of a small or a medium waterworks shall monitor during each six-month monitoring period until the waterworks exceeds the lead or copper AL and is therefore required to implement the corrosion control treatment requirements under 12VAC5-590-405 A 2, in which case the owner shall continue monitoring in accordance with subdivision B 4 b of this section, or the waterworks meets the lead and copper ALs during two consecutive six-month monitoring periods, in which case the owner may reduce monitoring in accordance with subdivision B 4 d of this section.

b. Monitoring after installation of corrosion control and source water treatment.

(1) The owner of a large waterworks that installs optimal corrosion control treatment pursuant to 12VAC5-590-405 A 2 d (4) shall monitor during two consecutive six-month monitoring periods by the date specified in 12VAC5-590-405 A 2 d (5).

(2) The owner of a small or a medium waterworks that installs optimal corrosion control treatment pursuant to 12VAC5-590-405 A 2 e (5) shall monitor during two consecutive six-month monitoring periods by the date specified in 12VAC5-590-405 A 2 e (6).

(3) The owner of a waterworks that installs source water treatment pursuant to 12VAC5-590-405 B 1 c shall monitor during two consecutive six-month monitoring periods by the date specified in 12VAC5-590-405 B 1 d.

c. Monitoring after the department specifies water quality parameter values for optimal corrosion control. After the department specifies the values for water quality control parameters under 12VAC5-590-405 A 1 f, the owner shall monitor during each subsequent six-month monitoring period, with the first monitoring period to begin on the date the department specifies the optimal values.

d. Reduced monitoring.

(1) The owner of a small or a medium waterworks that meets the lead and copper ALs during each of two consecutive six-month monitoring periods may reduce the number of samples in accordance with subdivision B 3 of this section, and reduce the frequency of sampling to once per year. The owner of a small or a medium waterworks collecting fewer than five samples, as specified in subdivision B 3 b of this section, that meets the lead and copper ALs during each of two consecutive six-month monitoring periods may reduce the frequency of sampling to once per year. In no case may the owner reduce the number of samples required below the minimum of one sample per available tap. This sampling shall begin during the calendar year immediately following the end of the second consecutive six-month monitoring period.

(2) The owner of a waterworks that meets the lead AL and maintains the range of values for the water quality control parameters reflecting optimal corrosion control treatment specified by the department under 12VAC5-590-405 A 1 f during each of two consecutive six-month monitoring periods may reduce the frequency of monitoring to once per year and to reduce the number of lead and copper samples in accordance with subdivision B 3 of this section if the owner receives written approval from the department. This sampling shall begin during the calendar year immediately following the end of the second consecutive six-month monitoring period. The department shall evaluate monitoring, treatment, and other relevant information submitted by the owner in accordance with 12VAC5-590-532 and shall notify the owner in writing when a determination is made that the owner is eligible to commence reduced monitoring pursuant to this subdivision. The department shall evaluate and, where appropriate, revise the determination when the owner submits new monitoring or treatment data or when other data relevant to the number and frequency of tap sampling becomes available.

(3) The owner of a small or a medium waterworks that meets the lead and copper ALs during three consecutive years of monitoring may reduce the frequency of monitoring for lead and copper from annually to once every three years. The owner of a waterworks that meets the lead AL and maintains the range of values for the water quality control parameters reflecting optimal corrosion control treatment specified by the department under 12VAC5-590-405 A 1 f during three consecutive years of monitoring may reduce the frequency of monitoring from annually to once every three years if the owner receives written approval from the department. Samples collected once every three years shall be collected no later than every third calendar year. The department shall evaluate monitoring, treatment, and other relevant information submitted by the owner in accordance with 12VAC5-590-532 and shall notify the owner in writing when a determination is made that the owner is eligible to commence reduced monitoring pursuant to this subdivision. The department shall evaluate and where appropriate, revise the determination when the owner submits new monitoring or treatment data, or when other data relevant to the number and frequency of tap sampling becomes available.

(4) The owner of a waterworks that reduces the number and frequency of sampling shall collect these samples from representative sites included in the pool of targeted sampling sites identified in subdivision B 1 of this section. The owner sampling annually or less frequently shall conduct the lead and copper tap sampling during the months of June, July, August, or September. For a NTNC that does not operate during the months of June through September, the department shall designate an alternate monitoring period that represents a time of normal operation for the waterworks. This sampling shall begin in the calendar year immediately following the end of the second consecutive six-month monitoring period for the owner initiating annual monitoring, and during the three-year period following the end of the third consecutive calendar year of annual monitoring for the owner initiating triennial monitoring.

(5) The owner of a waterworks that demonstrates for two consecutive six-month monitoring periods that the tap water lead level computed under 12VAC5-590-385 C is less than or equal to 0.005 mg/L and the tap water copper level computed under 12VAC5-590-385 C is less than or equal to 0.65 mg/L may reduce the number of samples in accordance with subdivision B 3 of this section and reduce the frequency of sampling to once every three calendar years.

(6) The owner of a small or a medium waterworks subject to reduced monitoring that exceeds the lead or copper AL shall resume sampling in accordance with subdivision B 4 c of this section and collect the number of samples specified for standard monitoring under subdivision B 3 of this section. The owner shall also conduct water quality parameter monitoring in accordance with subdivisions C 2, C 3, and C 4 of this section (as appropriate) during the monitoring period in which the AL is exceeded. The owner of a waterworks may resume annual monitoring for lead and copper at the tap at the reduced number of sites specified in subdivision B 3 of this section after it has completed two subsequent consecutive six-month rounds of monitoring that meet the criteria of subdivision B 4 d (1) of this section or may resume triennial monitoring for lead and copper at the reduced number of sites after it demonstrates through subsequent rounds of monitoring that it meets the criteria of either subdivision B 4 d (3) or B 4 d (5) of this section.

(7) The owner of a waterworks subject to the reduced monitoring frequency that fails to meet the lead ALs during any four-month monitoring period or that fails to operate at or above the minimum value or within the range of values for the water quality parameters specified by the department under 12VAC5-590-405 A 1 f for more than nine days in any six-month period specified in subdivision C 4 of this section shall conduct tap water sampling for lead and copper at the frequency specified in subdivision B 4 c of this section, collect the number of samples specified for standard monitoring under subdivision B 3 of this section, and resume monitoring for water quality parameters within the distribution system in accordance with subdivision C 4 of this section. This standard tap water sampling shall begin no later than the six-month period beginning January 1 of the calendar year following the lead AL exceedance or water quality parameter excursion. The owner of such a waterworks may resume reduced monitoring for lead and copper at the tap and for water quality parameters within the distribution system under the following conditions:

(a) The owner may resume annual monitoring for lead and copper at the tap at the reduced number of sites specified in subdivision B 3 of this section after completion of two subsequent six-month rounds of monitoring that meet the criteria of subdivision B 4 d (2) of this section and the owner has received written approval from the department that it is appropriate to resume reduced monitoring on an annual frequency. This sampling shall begin during the calendar year immediately following the end of the second consecutive six-month monitoring period.

(b) The owner may resume triennial monitoring for lead and copper at the tap at the reduced number of sites after demonstration through subsequent rounds of monitoring that it meets the criteria of either subdivision B 4 d (3) or B 4 d (5) of this section and the owner has received written approval from the department that it is appropriate to resume triennial monitoring.

(c) The owner may reduce the number of water quality parameter tap water samples required in accordance with subdivision C 5 a of this section and the frequency with which it collects these samples in accordance with subdivision C 5 b of this section. The owner of such a waterworks may not resume triennial monitoring for water quality parameters at the tap until it demonstrates, in accordance with the requirements of subdivision C 5 b of this section, that it has requalified for triennial monitoring.

(8) The owner of a waterworks subject to a reduced monitoring frequency under subdivision B 4 d of this section shall notify the department in writing in accordance with 12VAC5-590-530 and 12VAC5-590-532 of any upcoming long-term change in the treatment or addition of a new source water as described in this section. The department shall evaluate and approve the addition of a new source water or long-term change in the water treatment before it is implemented by the owner. The department may require the owner to resume sampling in accordance with subdivision B 4 c of this section and collect the number of samples specified for standard monitoring under subdivision B 3 of this section or take other appropriate steps such as increased water quality parameter monitoring or re-evaluation of its corrosion control treatment given the potentially different water quality considerations.

5. Additional monitoring by owner. The results of monitoring conducted in addition to the minimum requirements of this section shall be considered by the owner and the department in making determinations (i.e., calculating the 90th percentile lead or copper level) under 12VAC5-590-385 C.

6. Invalidation of lead or copper tap water samples. A sample invalidated under this subdivision does not count toward determining lead or copper 90th percentile levels under 12VAC5-590-385 C or toward meeting the minimum monitoring requirements of subdivision B 3 of this section.

a. The department may invalidate a lead or copper tap water sample if at least one of the following conditions is met:

(1) The laboratory establishes that improper sample analysis caused erroneous results.

(2) The department determines that the sample was collected from a site that did not meet the site selection criteria of this section.

(3) The sample container was damaged in transit.

(4) There is substantial reason to believe that the sample was subject to tampering.

b. The owner shall report the results of all samples to the department and all supporting documentation for samples the owner believes should be invalidated.

c. To invalidate a sample under subdivision B 6 a of this section, the decision and the rationale for the decision shall be documented in writing. The department may not invalidate a sample solely on the grounds that a follow-up sample result is higher or lower than that of the original sample.

d. The owner shall collect a replacement sample for a sample invalidated under this section if after the invalidation of one or more samples, the owner has too few samples to meet the minimum requirements of subdivision B 3 of this section. A replacement sample shall be collected as soon as possible, but no later than 20 days after the date the department invalidates the sample or by the end of the applicable monitoring period, whichever occurs later. Replacement samples collected after the end of the applicable monitoring period shall not also be used to meet the monitoring requirements of a subsequent monitoring period. The replacement samples shall be collected at the same locations as the invalidated samples or, if that is not possible, at locations other than those already used for sampling during the monitoring period.

7. Monitoring waivers for small waterworks. The owner of a small waterworks that meets the criteria of this subdivision may apply to the department to reduce the frequency of monitoring for lead and copper to once every nine years (i.e., a full waiver) if the owner meets all of the materials criteria specified in subdivision B 7 a of this section and all of the monitoring criteria specified in subdivision B 7 b of this section. The owner of a small waterworks that meets the criteria in subdivisions B 7 a and B 7 b of this section only for lead, or only for copper, may apply to the department for a waiver to reduce the frequency of tap water monitoring to once every nine years for that contaminant only (i.e., a partial waiver).

a. Materials criteria. The owner shall demonstrate that the distribution system service lines and plumbing connected to the waterworks, including plumbing conveying drinking water within all residences and buildings connected to the waterworks, are free of lead-containing materials or copper-containing materials, as those terms are defined in this subdivision, as follows:

(1) Lead. To qualify for a full waiver, or a waiver of the tap water monitoring requirements for lead (i.e., a lead waiver), the owner shall provide certification and supporting documentation to the department that the waterworks is free of all lead-containing materials, as follows:

(a) It contains no plastic pipes that contain lead plasticizers, or plastic service lines that contain lead plasticizers;

(b) Solders and flux contain no more than 0.2% lead; and

(c) The weighted average of wetted surface of pipes, pipe fittings, plumbing fittings, and plumbing fixtures contain no more than 0.25% lead.

(2) Copper. To qualify for a full waiver, or a waiver of the tap water monitoring requirements for copper (i.e., a copper waiver), the owner shall provide certification and supporting documentation to the department that the waterworks contains no copper pipes or copper service lines.

b. Monitoring criteria for waiver issuance. The owner shall have completed at least one six-month round of standard tap water monitoring for lead and copper at sites approved by the department and from the number of sites required by subdivision B 3 of this section and demonstrate that the 90th percentile levels for any and all rounds of monitoring conducted since the owner became free of all lead-containing or copper-containing materials, as appropriate, meet the following criteria:

(1) Lead levels. To qualify for a full waiver, or a lead waiver, the owner shall demonstrate that the 90th percentile lead level does not exceed 0.005 mg/L.

(2) Copper levels. To qualify for a full waiver, or a copper waiver, the owner shall demonstrate that the 90th percentile copper level does not exceed 0.65 mg/L.

c. Department approval of waiver application. The department shall notify the owner of the waiver determination, in writing, setting forth the basis of the decision and any condition of the waiver. As a condition of the waiver, the department may require the owner to perform specific activities (e.g., limited monitoring, periodic outreach to customers to remind them to avoid installation of materials that might void the waiver) to avoid the risk of lead or copper concentration of concern in tap water. The owner of a small waterworks shall continue monitoring for lead and copper at the tap as required by subdivisions B 4 a through B 4 d of this section, as appropriate, until it receives written notification from the department that the waiver has been approved.

d. Monitoring frequency for owners with waivers.

(1) The owner with a full waiver shall conduct tap water monitoring for lead and copper in accordance with subdivision B 4 d (4) of this section at the reduced number of sampling sites identified in subdivision B 3 of this section at least once every nine years and provide the materials certification specified in subdivision B 7 a of this section for both lead and copper to the department along with the monitoring results. Samples collected every nine years shall be collected no later than every ninth calendar year.

(2) The owner with a partial waiver shall conduct tap water monitoring for the waived contaminant in accordance with subdivision B 4 d (4) of this section at the reduced number of sampling sites specified in subdivision B 3 of this section at least once every nine years and provide the materials certification specified in subdivision B 7 a of this section pertaining to the waived contaminant along with the monitoring results. The owner also shall continue to monitor for the nonwaived contaminant in accordance with requirements of subdivisions B 4 a through B 4 d of this section, as appropriate.

(3) The owner with a full or partial waiver shall notify the department in writing in accordance with 12VAC5-590-532 B 3 of any upcoming long-term change in the treatment or addition of a new source water, as described in 12VAC5-590-532. The department shall evaluate and approve the addition of a new source water or a long-term change in water treatment before it is implemented by the owner. The department has the authority to require the owner to add or modify waiver conditions (e.g., require recertification that the waterworks is free of lead-containing or copper-containing materials; require additional round or rounds of monitoring), if it deems these modifications are necessary to address treatment or source water changes at the waterworks.

(4) If an owner with a full or partial waiver becomes aware that it is no longer free of lead-containing or copper-containing materials, as appropriate (e.g., as a result of new construction or repairs), then the owner shall notify the department in writing no later than 60 days after becoming aware of the change.

e. Continued eligibility. If the owner continues to satisfy the requirements of subdivision B 7 d of this section, then the waiver will be renewed automatically, unless any of the conditions listed in subdivision B 7 e (1), B 7 e (2), or B 7 e (3) of this section occurs. The owner whose waiver has been revoked may reapply for a waiver when the owner again meets the appropriate materials and monitoring criteria of subdivisions B 7 a and B 7 b of this section.

(1) A waterworks with a full waiver or a lead waiver no longer satisfies the materials criteria of subdivision B 7 a (1) of this section or has a 90th percentile lead level greater than 0.005 mg/L.

(2) A waterworks with a full waiver or a copper waiver no longer satisfies the materials criteria of subdivision B 7 a (2) of this section or has a 90th percentile copper level greater than 0.65 mg/L.

(3) The department notifies the owner, in writing, that the waiver has been revoked, setting forth the basis of the decision.

f. Requirements following waiver revocation. A waterworks whose full or partial waiver has been revoked by the department is subject to the corrosion control treatment and lead and copper tap water monitoring requirements, as follows:

(1) If the waterworks exceeds the lead or copper AL, then the owner shall implement corrosion control treatment in accordance with the deadlines specified in 12VAC5-590-405 A 2 e and any other applicable requirements of this section.

(2) If the waterworks meets both the lead and the copper ALs, then the owner shall monitor for lead and copper at the tap no less frequently than once every three years using the reduced number of sample sites specified in subdivision B 3 of this section.

g. Pre-existing waivers. Waivers for small waterworks approved by the department in writing before April 11, 2000, shall remain in effect under the following conditions:

(1) If the waterworks has demonstrated that it is both free of lead-containing and copper-containing materials, as required by subdivision B 7 a of this section and that its 90th percentile lead levels and 90th percentile copper levels meet the criteria of subdivision B 7 b of this section, then the waiver will remain in effect so long as the owner continues to meet the waiver eligibility criteria of subdivision B 7 e of this section. The first round of tap water monitoring conducted pursuant to subdivision B 7 d of this section shall be completed no later than nine years after the last time the owner has monitored for lead and copper at the tap.

(2) If the waterworks has met the materials criteria of subdivision B 7 a of this section but has not met the monitoring criteria of subdivision B 7 b of this section, then the owner shall conduct one six-month round of standard tap water monitoring for lead and copper at sites approved by the department demonstrating that it meets the criteria of subdivision B 7 b of this section. Thereafter, the waiver shall remain in effect as long as the owner meets the continued eligibility criteria of subdivision B 7 e of this section. The first round of tap water monitoring conducted pursuant to subdivision B 7 d of this section shall be completed no later than nine years after the round of monitoring conducted pursuant to subdivision B 7 b of this section.

C. Monitoring requirements for water quality parameters. The owners of all large waterworks and all small and medium waterworks that exceed the lead or copper AL shall monitor for water quality parameters in addition to lead and copper in accordance with this section.

1. General requirements.

a. Sample collection methods.

(1) Tap samples shall be representative of water quality throughout the distribution system taking into account the number of persons served, the different sources of water, the different treatment methods employed by the waterworks, and seasonal variability. Tap sampling under this section is not required to be conducted at taps targeted for lead and copper sampling under subdivision B 1 of this section. The owner may find it convenient to conduct tap sampling for water quality parameters at sites approved for coliform sampling.

(2) Samples collected at the entry point or points to the distribution system shall be from locations representative of each source water after treatment. If a waterworks draws water from more than one source water and the source waters are combined before distribution, then the owner shall sample at an entry point to the distribution system during periods of normal operating conditions (i.e., when water is representative of all source waters being used).

b. Number of samples.

(1) The owner shall collect two tap samples from the standard monitoring number of sites given in Table 375.2 for applicable water quality parameters during each monitoring period specified under subdivisions C 2 through C 5 of this section.

| TABLE 375.2 Water Quality Monitoring for Lead and Copper | | | | --- | --- | --- | | | NUMBER OF SITES FOR WATER QUALITY PARAMETERS | | | WATERWORKS SIZE (Number of People Served) | STANDARD MONITORING | REDUCED MONITORING | | Greater than 100,000 | 25 | 10 | | 10,001-100,000 | 10 | 7 | | 3,301 to 10,000 | 3 | 3 | | 501 to 3,300 | 2 | 2 | | 101 to 500 | 1 | 1 | | Less than or equal to 100 | 1 | 1 |

(2) Except as provided in subdivision C 3 c of this section, the owner shall collect two samples for each applicable water quality parameter at each entry point to the distribution system during each monitoring period specified in subdivision C 2 of this section. During each monitoring period specified in subdivisions C 3, C 4, and C 5 of this section, the owner shall collect one sample for each applicable water quality parameter at each entry point to the distribution system.

2. Initial sampling. The owner of a large waterworks shall measure the applicable water quality parameters as specified below at taps and at each entry point to the distribution system during each six-month monitoring period specified in subdivision B 4 a of this section. The owner of a small or a medium waterworks shall measure the applicable water quality parameters at the locations specified below during each six-month monitoring period specified in subdivision B 4 a of this section during which the waterworks exceeds the lead or copper AL.

a. At taps:

(1) pH;

(2) Alkalinity;

(3) Orthophosphate, when an inhibitor containing a phosphate compound is used;

(4) Silica, when an inhibitor containing a silicate compound is used;

(5) Calcium;

(6) Conductivity; and

(7) Water temperature.

b. At each entry point to the distribution system: all of the applicable parameters listed in subdivision C 2 a of this section.

3. Monitoring after installation of corrosion control. The owner of a large waterworks that installs optimal corrosion control treatment pursuant to 12VAC5-590-405 A 2 d (4) shall measure the water quality parameters at the locations and frequencies specified below during each six-month monitoring period specified in subdivision B 4 b (1) of this section. The owner of a small or a medium waterworks that installs optimal corrosion control treatment shall conduct monitoring during each six-month monitoring period specified in subdivision B 4 b (2) of this section in which the waterworks exceeds the lead or copper AL.

a. At taps, two samples for:

(1) pH;

(2) Alkalinity;

(3) Orthophosphate, when an inhibitor containing a phosphate compound is used;

(4) Silica, when an inhibitor containing a silicate compound is used; and

(5) Calcium, when calcium carbonate stabilization is used as part of corrosion control.

b. Except as provided in subdivision C 3 c of this section, at each entry point to the distribution system, at least one sample no less frequently than every two weeks (biweekly) for:

(1) pH;

(2) When alkalinity is adjusted as part of optimal corrosion control, a reading of the dosage rate of the chemical used to adjust the alkalinity and the alkalinity concentration; and

(3) When a corrosion inhibitor is used as part of optimal corrosion control, a reading of the dosage rate of the inhibitor used and the concentration of orthophosphate or silica (whichever is applicable).

c. The owner of a groundwater system may limit entry point sampling described in subdivision C 3 b of this section to those entry points that are representative of water quality and treatment conditions throughout the waterworks. If water from untreated groundwater sources mixes with water from treated groundwater sources, then the owner shall monitor for water quality parameters both at representative entry points receiving treatment and representative entry points receiving no treatment. Before the start of any monitoring under this subdivision, the owner shall provide to the department written information identifying the selected entry points and documentation, including information on seasonal variability, sufficient to demonstrate that the sites are representative of water quality and treatment conditions throughout the waterworks.

4. Monitoring after the department specifies water quality parameter values for optimal corrosion control. After the department specifies the values for applicable water quality control parameters reflecting optimal corrosion control treatment under 12VAC5-590-405 A 1 f, the owner of a large waterworks shall measure the applicable water quality parameters in accordance with subdivision C 3 of this section and determine compliance with the requirements of 12VAC5-590-405 A 1 g every six months with the first six-month period to begin on either January 1 or July 1, whichever comes first, after the department specifies the optimal values under 12VAC5-590-405 A 1 f. The owner of a small or a medium waterworks shall conduct monitoring during each six-month monitoring period specified in this subdivision in which the waterworks exceeds the lead or copper AL. For the owner of a small or a medium waterworks that is subject to a reduced monitoring frequency pursuant to subdivision B 4 d of this section at the time of the AL exceedance, the start of the applicable six-month period under this subdivision shall coincide with the start of the applicable monitoring period under subdivision B 4 d of this section. Compliance with the department-designated optimal water quality parameter values shall be determined as specified under 12VAC5-590-405 A 1 g.

5. Reduced monitoring.

a. The owner of a waterworks that maintains the range of values for the water quality parameters reflecting optimal corrosion control treatment during each of two consecutive six-month monitoring periods under subdivision C 4 of this section shall continue monitoring at the entry point or points to the distribution system as specified in subdivision C 3 b of this section. The owner of the waterworks may collect two tap samples for applicable water quality parameters from the reduced number of sites during each six-month monitoring period shown in Table 375.2.

| | | | --- | --- | | | | | | | | | | | | | | | | | | |

b. The owner of a waterworks that maintains the range of values for the water quality parameters reflecting optimal corrosion control treatment specified by the department under 12VAC5-590-405 A 1 f during three consecutive years of monitoring may reduce the frequency with which the owner collects the number of tap samples for applicable water quality parameters specified in subdivision C 5 of this section from every six months to annually. This sampling begins during the calendar year immediately following the end of the monitoring period in which the third consecutive year of six-month monitoring occurs. The owner of a waterworks that maintains the range of values for the water quality parameters reflecting optimal corrosion control treatment specified by the department under 12VAC5-590-405 A 1 f during three consecutive years of annual monitoring under this subdivision may reduce the frequency with which it collects the number of tap samples for applicable water quality parameters specified in subdivision C 5 a of this section from annually to every three years. This sampling begins during the calendar year immediately following the end of the monitoring period in which the third consecutive year of six-month monitoring occurs.

c. The owner of a waterworks may reduce the frequency with which tap samples are collected for applicable water quality parameters specified in subdivision C 5 a of this section to every three years if the owner demonstrates during two consecutive monitoring periods that the tap water lead level at the 90th percentile is less than or equal to the PQL for lead (0.005 mg/L), that the tap water copper level at the 90th percentile is less than or equal to 0.65 mg/L for copper, and that the owner also has maintained the range of values for water quality parameters reflecting optimal corrosion control treatment specified by the department under 12VAC5-590-405 A 1 f. Monitoring conducted every three years shall be done no later than every third calendar year.

d. The owner of a waterworks that conducts sampling annually shall collect these samples evenly throughout the year so as to reflect seasonal variability.

e. The owner of a waterworks subject to the reduced monitoring frequency that fails to operate at or above the minimum value or within the range of values for the water quality parameters specified by the department under 12VAC5-590-405 A 1 f for more than nine days in any six-month period specified in 12VAC5-590-405 A 1 g shall resume distribution system tap water sampling in accordance with the number and frequency requirements in subdivision C 4 of this section. The owner may resume annual monitoring for water quality parameters at the tap at the reduced number of sites specified in subdivision C 5 of this section after completion of two subsequent consecutive six-month rounds of monitoring that meet the criteria of that subdivision or may resume triennial monitoring for water quality parameters at the tap at the reduced number of sites after demonstration through subsequent rounds of monitoring that the criteria of either subdivision C 5 b or C 5 c of this section has been met.

6. Additional monitoring by owners. The results of any monitoring conducted in addition to the minimum requirements of this section shall be considered by the owner and the department in making any determinations under this section or 12VAC5-590-405 A 1.

D. Monitoring requirements for lead and copper in water supplies (source water).

1. Sample location, collection methods, and number of samples.

a. The owner of a waterworks that fails to meet the lead or copper AL on the basis of tap samples collected in accordance with subsection A of this section shall collect lead and copper source water samples in accordance with the following requirements regarding sample location, number of samples, and collection methods:

(1) The owner of a waterworks served by groundwater sources shall collect a minimum of one sample at every entry point to the distribution system. The owner shall collect one sample at the same sampling point unless conditions make another sampling point more representative of each source water or water treatment plant.

(2) The owner of a waterworks served by surface water sources shall collect a minimum of one sample at every entry point to the distribution system. The owner shall collect each sample at the same sampling point unless conditions make another sampling point more representative of each source water or water treatment plant. Note that for the purpose of this subdivision, a waterworks served by a surface water source includes waterworks served by a combination of surface water and groundwater sources.

(3) If a waterworks draws water from more than one source water and the source waters are combined before distribution, then the owner shall collect samples at an entry point to the distribution system during periods of normal operating conditions (i.e., when water is representative of all source waters being used).

(4) The department may reduce the total number of samples that must be analyzed by allowing the use of compositing. Compositing of samples shall be done by certified laboratory personnel. Composite samples from a maximum of five samples are allowed, provided that if the lead concentration in the composite sample is greater than or equal to 0.001 mg/L or the copper concentration is greater than or equal to 0.160 mg/L, then either a follow-up sample shall be collected and analyzed within 14 days at each sampling point included in the composite; or if duplicates or sufficient quantities from the original samples from each sampling point used in the composite are available, then the owner may use these instead of resampling.

b. Where the results of sampling indicate an exceedance of maximum permissible source water levels established under 12VAC5-590-405 B 4, the department may require that one additional sample be collected as soon as possible after the initial sample was collected (but not to exceed two weeks) at the same sampling point. If a confirmation sample required by the department is collected for lead or copper, then the results of the initial and confirmation sample shall be averaged in determining compliance with the department-specified maximum permissible levels. A sample value below the MDL shall be considered to be zero. A value above the MDL but below the PQL shall either be considered as the measured value or be considered one-half the PQL. The PQL for lead is equal to 0.005 mg/L, and the PQL for copper is equal to 0.050 mg/L.

2. Monitoring frequency after a waterworks exceeds a tap AL. The owner of a waterworks that exceeds the lead or copper AL at the tap shall collect one source water sample from each entry point to the distribution system no later than six months after the end of the monitoring period during which the lead or copper AL was exceeded. For monitoring periods that are annual or less frequent, the end of the monitoring period is September 30 of the calendar year in which the sampling occurs, or if the department has established an alternate monitoring period, the last day of that period.

3. Monitoring frequency after installation of source water treatment. The owner of a waterworks that installs source water treatment pursuant to 12VAC5-590-405 B 1 c shall collect an additional source water sample from each entry point to the distribution system during two consecutive six-month monitoring periods by the deadline specified in 12VAC5-590-405 B 1 d.

4. Monitoring frequency after the department specifies maximum permissible source water lead and copper levels or determines that source water treatment is not needed.

a. The owner shall monitor at the frequency specified in subdivisions D 4 a (1) and D 4 a (2) of this section in cases where the department specifies maximum permissible source water lead and copper levels under 12VAC5-590-405 B 1 e or determines that the owner is not required to install source water treatment under 12VAC5-590-405 B 2 b.

(1) The owner of a waterworks using only groundwater shall collect samples once during the three-year compliance period in effect when the applicable department determination under subdivision D 4 a of this section is made. The owner shall collect samples once during each subsequent compliance period. Triennial samples shall be collected every third calendar year.

(2) The owner of a waterworks using surface water (or a combination of surface water and groundwater) shall collect samples once during each year, the first annual monitoring period to begin during the year in which the applicable department determination is made under subdivision D 4 a of this section.

b. The owner is not required to conduct source water sampling for lead or copper if the waterworks meets the AL for the specific contaminant in tap water samples during the entire source water sampling period applicable to the waterworks under subdivision D 4 a (1) or D 4 a (2) of this section.

5. Reduced monitoring frequency.

a. The owner of a waterworks using only groundwater may reduce the monitoring frequency for lead and copper in source waters to once during each nine-year compliance cycle provided that the samples are collected no later than every ninth calendar year and if the owner meets one of the following criteria:

(1) The owner demonstrates that the finished water entering the distribution system has been maintained below the maximum permissible lead and copper concentrations specified by the department under 12VAC5-590-405 B 1 e during at least three consecutive compliance periods under subdivision D 4 a of this section; or

(2) The department has determined that source water treatment is not needed and the owner demonstrates that, during the last three consecutive compliance periods in which sampling was conducted under subdivision D 4 a of this section, the concentration of lead in the source water was less than or equal to 0.005 mg/L and the concentration of copper in the source water was less than or equal to 0.65 mg/L.

b. The owner of a waterworks using surface water (or a combination of surface water and groundwater sources) may reduce the monitoring frequency for lead and copper in source waters to once during each nine-year compliance cycle provided that the samples are collected no later than every ninth calendar year and if the owner meets one of the following criteria:

(1) The owner demonstrates that finished water entering the distribution system has been maintained below the maximum permissible lead and copper concentrations specified by the department under 12VAC5-590-405 B 1 e for at least three consecutive years; or

(2) The department has determined that source water treatment is not needed and the owner demonstrates that, during the last three consecutive years, the concentration of lead in the source water was less than or equal to 0.005 mg/L and the concentration of copper in the source water was less than or equal to 0.65 mg/L.

c. The owner of a waterworks that uses a new source water is not eligible for reduced monitoring for lead or copper until concentrations in samples collected from the new source water during three consecutive monitoring periods are below the maximum permissible lead and copper concentrations specified in 12VAC5-590-405 B 1 e.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 27, Issue 1, eff. October 13, 2010; amended, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-376 Surface water and GUDI sources treatment monitoring

A. The owner of a waterworks that uses a surface water source, a GUDI source, or both and provides filtration treatment shall monitor in accordance with this section.

B. Turbidity measurements shall be performed on representative samples of the filtered water every four hours (or more frequently) that the waterworks serves water to the public. The owner may substitute continuous turbidity monitoring for grab sample monitoring if the owner validates the continuous measurement for accuracy on a regular basis using a protocol approved by the department. For a waterworks using slow sand filtration or filtration treatment other than conventional treatment, direct filtration, or diatomaceous earth filtration, the department may reduce the sampling frequency to once per day if the department determines that less frequent monitoring is sufficient to indicate effective filtration performance. For a waterworks serving 500 or fewer persons, the department may reduce the turbidity sampling frequency to once per day, regardless of the type of filtration treatment used, if the department determines that less frequent monitoring is sufficient to indicate effective filtration performance.

1. The owner of a waterworks supplied by a surface water source, a GUDI source, or both using conventional filtration treatment or direct filtration shall conduct continuous monitoring of turbidity for each individual filter. The turbidimeter shall be calibrated using the procedure specified by the turbidimeter manufacturer. The owner shall record the results of individual filter turbidity monitoring a minimum of every 15 minutes.

2. If there is a failure in the continuous turbidity monitoring equipment, then the owner shall conduct grab sampling every four hours instead of continuous monitoring but for no more than five working days (for a waterworks serving 10,000 or more persons) or 14 days (for a waterworks serving fewer than 10,000 persons) following the failure of the equipment.

3. If a waterworks serving fewer than 10,000 persons consists of two or fewer filters, continuous monitoring of the CFE may be used instead of individual filter monitoring.

C. The residual disinfectant concentration of the water entering the distribution system shall be monitored continuously, and the lowest and highest values shall be recorded each day. If there is a failure in the continuous monitoring equipment, then grab sampling every four hours shall be conducted instead of continuous monitoring, but such grab sampling shall be conducted for no more than five working days following the failure of the equipment. The owner of a waterworks serving 3,300 or fewer persons may collect grab samples instead of continuous monitoring on an ongoing basis at the frequencies prescribed in Table 376.1.

1. The day's samples cannot be collected at the same time.

2. The sampling intervals are subject to department's evaluation and approval.

3. If at any time the residual disinfectant concentration falls below 0.2 mg/L in a waterworks using grab sampling instead of continuous monitoring, then the owner shall collect a grab sample every four hours until the residual disinfectant concentration is equal to or greater than 0.2 mg/L.

| TABLE 376.1 Grab Sample Monitoring Frequency | | | --- | --- | | WATERWORKS SIZE BY POPULATION | SAMPLES/DAY | | 500 or less | 1 | | 501 - 1,000 | 2 | | 1,000 - 2,500 | 3 | | 2,501 - 3,300 | 4 |

D. The residual disinfectant concentration shall be measured at least at the same points in the distribution system and at the same time as total coliform bacteria are sampled, as specified in 12VAC5-590-370 A and 12VAC5-590-380 D, except that the department may allow the owner of a waterworks that uses a groundwater source along with a surface water source, a GUDI source, or both to collect residual disinfectant samples at points other than the total coliform sampling points if the department determines that these points are more representative of treated (disinfected) water quality within the distribution system. Heterotrophic bacteria, measured as HPC as specified in 12VAC5-590-395 A 2 a (3), may be measured instead of residual disinfectant concentration.

E. The following information on the samples collected in the distribution system in conjunction with total coliform monitoring pursuant to 12VAC5-590-395 A 2 shall be reported monthly to the department by the owner:

1. Number of instances where the residual disinfectant concentration is measured;

2. Number of instances where the residual disinfectant concentration is not measured but heterotropic plate count (HPC) is measured;

3. Number of instances where the residual disinfectant concentration is measured but not detected and no HPC is measured;

4. Number of instances where no residual disinfectant concentration is detected and where the HPC is greater than 500/mL;

5. Number of instances where the residual disinfectant concentration is not measured and HPC is greater than 500/mL; and

6. For the current and previous month the waterworks serves water to the public, the value of "V," in percent, in the following formula:

V = [(c + d + e) / (a + b)] X 100

where

a = the value in subdivision E 1 of this section;

b = the value in subdivision E 2 of this section;

c = the value in subdivision E 3 of this section;

d = the value in subdivision E 4 of this section;

e = the value in subdivision E 5 of this section.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-377 Physical constituent monitoring

A. Monitoring to determine compliance with the SMCLs for color, odor, pH, and total dissolved solids as specified in Table 340.3 shall be conducted as follows:

1. The owner shall collect one sample at each groundwater source entry point during each compliance period.

2. The owner shall collect one sample annually at each surface water source entry point, in whole or in part.

B. Onsite daily turbidity measurements may be required to be performed on representative samples collected at each entry point for groundwater sources not required to filter, to determine compliance set forth in 12VAC5-590-379 B. The turbidity monitoring requirements for a waterworks required to filter are specified in 12VAC5-590-376 B.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-378 Radiological monitoring

A. The location of sampling points, the radionuclides measured in community waterworks, the frequency, and the timing of sampling within each compliance period shall be established or approved by the department. The department may increase required monitoring where necessary to detect variations within the waterworks. Failure to comply with the sampling schedules in this section will require public notification pursuant to 12VAC5-590-540 A 3.

B. The owner of a community waterworks shall conduct monitoring to determine compliance with the PMCLs listed in Table 340.4 and 12VAC5-590-388 in accordance with this section.

1. Monitoring requirements for gross alpha particle activity, radium-226, radium-228, and uranium.

a. The owner shall conduct initial monitoring to determine compliance with the PMCLs listed in Table 340.4 for gross alpha particle activity, radium-226, radium-228, and uranium. For the purposes of monitoring for gross alpha particle activity, radium-226, radium-228, uranium, and beta particle and photon radioactivity in drinking water, "detection limit" is defined as specified in Table 378.1.

(1) Applicability and sampling location for an existing community waterworks or its sources. The owner using groundwater, surface water, or both groundwater and surface water shall sample at every entry point to the distribution system that is representative of all sources being used under normal operating conditions. The owner shall collect each sample at the same entry point unless conditions make another sampling point more representative of each source.

(2) Applicability and sampling location for a new community waterworks or its sources. A new community waterworks or a community waterworks that uses a new source water shall begin to conduct initial monitoring for the new source water within the first quarter after initiating use. The owner shall conduct more frequent monitoring when directed by the department in the event of possible contamination or when changes in the distribution system or treatment processes occur that may increase the concentration of radioactivity in the finished water.

b. Initial monitoring. The owner shall conduct initial monitoring for gross alpha particle activity, radium-226, radium-228, and uranium as follows:

(1) The owner shall collect four consecutive quarterly samples at all entry points.

(2) For gross alpha particle activity, uranium, radium-226, and radium-228 monitoring, the department may waive the final two quarters of initial monitoring for an entry point if the results of the samples from the previous two quarters are below the detection limit as defined by and as specified in Table 378.1.

(3) If the average of the initial monitoring results for an entry point is above the PMCL, then the owner shall collect and analyze quarterly samples at that entry point until the owner has results from four consecutive quarters that are at or below the PMCL, unless the owner enters into another schedule as part of a formal compliance agreement with the department.

c. Reduced monitoring. The department may allow the owner to reduce the future frequency of monitoring from once every three years to once every six or nine years at each entry point, based on the following criteria:

(1) If the average of the initial monitoring results for each contaminant (i.e., gross alpha particle activity, uranium, radium-226, or radium-228) is below the detection limit as specified in Table 378.1, then the owner shall collect and analyze for that contaminant using at least one sample at that entry point every nine years.

(2) For gross alpha particle activity, combined radium, and uranium, if the average of the initial monitoring results for each contaminant is at or above the detection limit as specified in Table 378.1, but at or below half of the PMCL, then the owner shall collect and analyze for that contaminant using at least one sample at that entry point every six years.

(3) For gross alpha particle activity, combined radium, and uranium, if the average of the initial monitoring results for each contaminant is above half the PMCL but at or below the PMCL, then the owner shall collect and analyze at least one sample at that entry point every three years.

(4) The owner shall use the samples collected during the reduced monitoring period to determine the monitoring frequency for subsequent monitoring periods (e.g., if a waterworks entry point is on a nine-year monitoring period, and the sample result is above half the PMCL, then the next monitoring period for that entry point is three years).

(5) If the owner has a monitoring result that exceeds the PMCL while on reduced monitoring, then the owner shall collect and analyze quarterly samples at that entry point until the results from four consecutive quarters are below the PMCL, unless the waterworks enters into another schedule as part of a formal compliance agreement with the department.

d. Compositing. To fulfill quarterly monitoring requirements for gross alpha particle activity, radium-226, radium-228, or uranium, the owner may composite up to four consecutive quarterly samples from a single entry point if analysis is done within a year of the first sample. The department will treat analytical results from the composited sample as the average analytical result to determine compliance with the PMCLs and the future monitoring frequency. If the analytical result from the composited sample is greater than half the PMCL, then the department may direct the owner to collect additional quarterly samples before allowing the owner to sample under a reduced monitoring schedule.

e. A gross alpha particle activity measurement may be substituted for the required radium-226 measurement provided that the measured gross alpha particle activity does not exceed 5 pCi/L. A gross alpha particle activity measurement may be substituted for the required uranium measurement provided that the measured gross alpha particle activity does not exceed 15 pCi/L. The gross alpha measurement shall have a confidence interval of 95% (1.65 σ, where σ is the standard deviation of the net counting rate of the sample) for radium-226 and uranium. When an owner uses a gross alpha particle activity measurement instead of a radium-226 or uranium measurement, the gross alpha particle activity analytical result will be used to determine the future monitoring frequency for radium-226 or uranium. If the gross alpha particle activity result is less than the detection limit as specified in Table 378.1, then half the detection limit will be used to determine compliance and the future monitoring frequency.

2. Monitoring requirements for beta particle and photon radioactivity. To determine compliance with the PMCL in Table 340.4 for beta particle and photon radioactivity, an owner shall monitor at a frequency as follows:

a. The owner (using surface water or groundwater sources) designated by the department as vulnerable shall sample for beta particle and photon radioactivity. The owner shall collect quarterly samples for beta emitters and annual samples for tritium and strontium-90 at each entry point to the distribution system, beginning within one quarter after being notified by the department. A waterworks already designated by the department shall continue to sample until the department evaluates and either reaffirms or removes the designation.

(1) If the gross beta particle activity minus the naturally occurring potassium-40 beta particle activity at an entry point has an RAA (computed quarterly) less than or equal to 50 pCi/L (screening level), then the department may reduce the frequency of monitoring at that entry point to once every three years. The owner shall collect all samples required in subdivision B 2 a of this section during the reduced monitoring period.

(2) For a waterworks in the vicinity of a nuclear facility, the department may allow the owner to utilize environmental surveillance data collected by the nuclear facility instead of monitoring at the waterworks entry point, where the department determines the data is applicable to a particular waterworks. In the event that there is a release from a nuclear facility, the owner who is using surveillance data shall begin monitoring at the waterworks entry point in accordance with subdivision B 2 a of this section.

b. The owner (using a surface water, a groundwater source, or both) designated by the department as utilizing waters contaminated by effluents from nuclear facilities shall sample for beta particle and photon radioactivity. The owner shall collect quarterly samples for beta emitters and iodine-131 and annual samples for tritium and strontium-90 at each entry point to the distribution system, beginning within one quarter after being notified by the department. The owner of a waterworks already designated by the department as using waters contaminated by effluents from nuclear facilities shall continue to sample until the department evaluates and either reaffirms or removes the designation.

(1) Quarterly monitoring for gross beta particle activity shall be based on the analysis of monthly samples or the analysis of a composite of three monthly samples. The former procedure, analysis of monthly samples, is recommended.

(2) For iodine-131, a composite of five consecutive daily samples shall be analyzed once each quarter. As directed by the department, more frequent monitoring shall be conducted when iodine-131 is identified in the finished water.

(3) Annual monitoring for strontium-90 and tritium shall be conducted by means of the analysis of a composite of four consecutive quarterly samples or analysis of four quarterly samples. The latter procedure, analysis of monthly samples, is recommended.

(4) If the gross beta particle activity minus the naturally occurring potassium-40 beta particle activity at a sampling point has an RAA (computed quarterly) less than or equal to 15 pCi/L (screening level), then the department may reduce the frequency of monitoring at that sampling point to every three years. The owner shall collect all samples required in subdivision B 2 b of this section during the reduced monitoring period.

(5) For a waterworks in the vicinity of a nuclear facility, the department may allow the owner to utilize environmental surveillance data collected by the nuclear facility instead of the monitoring at the waterworks entry point, where the department determines the data is applicable to a particular waterworks. In the event that there is a release from a nuclear facility, the owner who is using surveillance data shall begin monitoring at the waterworks entry point in accordance with subdivision B 2 b of this section.

c. The owner of a waterworks designated by the department to monitor for beta particle and photon radioactivity cannot apply to the department for a waiver from the monitoring frequencies specified in subdivision B 2 a or B 2 b of this section.

d. The owner may analyze for naturally occurring potassium-40 beta particle activity from the same or equivalent sample used for the gross beta particle activity analysis. The owner is allowed to subtract the potassium-40 beta particle activity value from the total gross beta particle activity value to determine if the screening level is exceeded. The potassium-40 beta particle activity shall be calculated by multiplying elemental potassium concentrations (in mg/L) by a factor of 0.82.

e. If the gross beta particle activity minus the naturally occurring potassium-40 beta particle activity exceeds the appropriate screening level, then an analysis of the sample shall be performed to identify the major radioactive constituents present in the sample and the appropriate doses shall be calculated and summed to determine compliance with the PMCL for beta particles and photon radioactivity. Doses shall also be calculated and combined for measured levels of tritium and strontium to determine compliance.

f. The owner shall monitor monthly at each entry point that exceeds the PMCLs listed in Table 340.4 beginning the month after the exceedance occurs. The owner shall continue monthly monitoring until the waterworks has established, by a rolling average of three monthly samples, that the PMCL is being met. The owner who establishes that the PMCL is being met shall return to quarterly monitoring until the requirements set forth in subdivision B 2 a (1) or B 2 b (4) of this section are met.

3. General monitoring requirements for radionuclides.

a. The department may require more frequent monitoring than specified in subdivisions B 1 and B 2 of this section or may require confirmation samples at the department's discretion. The results of the initial and confirmation samples shall be averaged for use in compliance determinations.

b. The owner shall monitor at the time designated by the department during each compliance period.

c. The department has the discretion to delete results of obvious sampling or analytic errors.

d. Table 378.1 provides the minimum detection limits for radiological analyses.

| TABLE 378.1 Minimum Detection Limits for Radiological Analyses | | | --- | --- | | CONTAMINANT | DETECTION LIMIT (pCi/L unless otherwise noted) | | Gross alpha | 3 | | Gross beta | 4 | | Cesium-134 | 10 | | Iodine-131 | 1 | | Radium-226 | 1 | | Radium 228 | 1 | | Strontium-89 | 10 | | Strontium-90 | 2 | | Tritium | 1,000 | | Uranium | 1 (µg/L) |

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-379 Groundwater system monitoring

A. General monitoring requirements.

1. The owner of a groundwater system, including consecutive and wholesale waterworks, shall conduct monitoring in accordance with this section, except that requirements do not apply to waterworks that combine all of their groundwater sources with surface water sources or with GUDI sources before treatment in accordance with 12VAC5-590-395.

2. Source water monitoring by the owner of a groundwater system that does not provide 4-log treatment of viruses for their groundwater sources before or at the first customer is described in subsection B of this section.

3. The owner of a groundwater system that provides at least 4-log treatment of viruses before or at the first customer is required to conduct compliance monitoring in accordance with 12VAC5-590-421 C.

4. The owner of a groundwater system that has confirmed E. coli contamination, as determined by source water monitoring conducted under subsection B of this section or has been notified of a significant deficiency as described in 12VAC5-590-350 D shall implement one or more of the corrective actions outlined in 12VAC5-590-421 A 1, as prescribed by the department.

5. The owner of a groundwater system that does not provide 4-log treatment of viruses before or at the first customer and is not performing compliance monitoring shall provide a triggered source water monitoring plan to the department.

6. Any source water sample collected in accordance with this section shall be analyzed for E. coli using one of the analytical methods in 40 CFR 141.402(c).

B. Groundwater source microbial monitoring.

1. Triggered source water monitoring.

a. General requirements. The groundwater system owner shall conduct triggered source water monitoring if both the conditions identified in subdivisions B 1 a (1) and B 1 a (2) of this section exist.

(1) The groundwater system owner does not provide at least 4-log treatment of viruses before or at the first customer for each groundwater source; and

(2) The groundwater system owner is notified that a sample collected under 12VAC5-590-370 A is total coliform positive and the sample is not invalidated under 12VAC5-590-380 E.

b. Sampling requirements. The groundwater system owner shall collect, within 24 hours of notification of the total coliform-positive sample, one source water sample from each groundwater source in use at the time the total coliform-positive sample was collected under 12VAC5-590-370 A, except as provided in this subdivision B 1 b.

(1) The department may extend the 24-hour time limit on a case-by-case basis if the owner cannot collect the source water sample within 24 hours due to circumstances beyond his control. In the case of an extension, the department shall specify how much time the owner has to collect the sample.

(2) If approved by the department, the owner of a waterworks with more than one groundwater source may meet the requirements of this subdivision B 1 by sampling representative groundwater sources. The owner shall submit for the department's approval a triggered source water monitoring plan that identifies one or more groundwater sources that are representative of each monitoring site in the waterworks' bacteriological sample siting report or that identifies groundwater sources that are hydrogeologically similar and clearly identifies which sources will be sampled.

(3) A groundwater system serving 1,000 people or fewer may use a triggered source water sample collected from a groundwater source to meet both the requirements of 12VAC5-590-380 and to satisfy the monitoring requirements of this subdivision B 1 for a groundwater source.

c. Additional requirements.

(1) If an E. coli-positive triggered source water sample collected under this subdivision B 1 is not invalidated under subdivision B 2 of this section, then the groundwater system owner shall provide public notification and collect five additional source water samples from the same source within 24 hours of being notified of the E. coli-positive sample.

(a) If the E. coli-positive triggered source water sample is also used as a repeat sample, then an E. coli PMCL violation is incurred under 12VAC5-590-380 B 1 a.

(b) If a waterworks collects more than one repeat sample at the monitoring location required for triggered source water monitoring, then the number of additional source water samples required under subdivision B 1 c (1) of this section may be reduced by the number of repeat samples collected at that location that were not E. coli positive.

(2) If any of the five additional samples are E. coli positive, the groundwater system owner shall comply with the treatment technique requirements of 12VAC5-590-421.

d. Consecutive and wholesale waterworks.

(1) A consecutive groundwater system owner that has a total coliform-positive sample collected in accordance with 12VAC5-590-370 A shall notify the wholesalewaterworks owner and the department within 24 hours of being notified of the total coliform-positive sample.

(2) The wholesale groundwater system owner shall comply with the following:

(a) The wholesale groundwater system owner that receives notice from a consecutive waterworks it serves that a sample collected in accordance with 12VAC5-590-370 A is total coliform positive shall, within 24 hours of being notified, collect a sample from each groundwater source as described in subdivision B 1 of this section.

(b) If the sample collected under this subdivision B 1 is E. coli positive, then the wholesale groundwater system owner shall within 24 hours notify all consecutive waterworks served by that groundwater source of the E. coli-positive source water sample as described in 12VAC5-590-540 and shall meet the requirements of subdivision B 1 c of this section.

e. Exception to the triggered source water monitoring requirements. A groundwater system owner is not required to comply with the source water monitoring requirements of this subdivision B 1 if the department determines and documents in writing that:

(1) The total coliform-positive sample collected in accordance with 12VAC5-590-370 A is invalidated under 12VAC5-590-380 E.

(2) The total coliform-positive sample collected in accordance with 12VAC5-590-370 A is caused by a distribution system deficiency (sanitary defect).

(3) The total coliform-positive sample collected in accordance with 12VAC5-590-370 A was caused by distribution system conditions that will cause total coliform-positive samples.

2. Invalidation of an E. coli-positive groundwater source sample.

a. The groundwater system owner may obtain the department's invalidation of an E. coli-positive groundwater source sample collected under subdivision B 1 of this section only under the following conditions:

(1) The groundwater system owner provides the department with written notice from the laboratory that improper sample analysis occurred; or

(2) The department determines and documents in writing that there is substantial evidence that the E. coli-positive groundwater source sample is not related to source water quality.

b. If the department invalidates an E. coli-positive groundwater source sample, then the groundwater system owner shall collect another source water sample under subdivision B 1 of this section within 24 hours of being notified by the department of the invalidation decision and have the source water sample analyzed for E. coli.

3. Sampling location. All groundwater source samples required under subdivision B 1 of this section shall be collected at a location before any treatment of the groundwater source unless otherwise approved by the department.

4. Public notification. The owner of a groundwater system with a source water sample collected under this subsection that is E. coli positive and that is not invalidated under subdivision B 2 of this section, including consecutive waterworks served by the groundwater source, shall conduct public notification as required in 12VAC5-590-540 A 1.

5. Monitoring violations. Failure to meet the monitoring requirements of subdivision B 1 of this section is a violation and requires the groundwater system owner to provide public notification as required in 12VAC5-590-540 A 3.

C. Monitoring requirements for source water.

1. The owner of a groundwater source utilizing chlorine disinfection or any other treatment or chemical addition that may alter or affect the bacteriological quality of the source water shall collect source water samples for bacteriological analysis in accordance with this section.

2. All bacteriological samples under this section shall be collected from the source water before any treatment or chemical addition.

a. The owner shall provide a suitable source water sample tap at each groundwater source.

b. If conditions indicate that it is not possible to install a source water sample tap, then an alternate sample location acceptable to the department may be utilized for this monitoring.

3. All samples shall be analyzed by a test method that will yield a most probable number (MPN) result for both total coliforms and E. coli.

4. Number of samples.

a. The number of routine source water samples to be collected and the frequency of sampling shall be determined by the department. The department will notify the owner of the source water sampling requirements.

b. As a minimum, the owner shall collect source water samples in accordance with Table 379.1.

| TABLE 379.1 Monitoring Requirements for Source Water Samples | | | | --- | --- | --- | | SOURCE TYPE | MINIMUM ROUTINE SOURCE WATER MONITORING FREQUENCY | PARAMETERS | | Well located in non-karst geology | One sample per year | Total coliforms MPN and E coli MPN | | Well located in karst geology | One sample per calendar quarter | Total coliforms MPN and E coliMPN | | Spring | One sample per month | Total coliforms MPN and E coliMPN |

c. When a single sample result from a groundwater source that requires a routine source water monitoring frequency of less than monthly indicates total coliforms in excess of 50 colonies/100 mL or the presence of E. coli, the owner shall collect one confirmation sample within seven calendar days after notification of the results.

d. The department may require that additional source water samples be collected and will establish the specific number of samples and the monitoring frequency.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011; amended, Virginia Register Volume 33, Issue 3, eff. November 2, 2016; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-380 Bacteriological compliance

A. The owner needs only to determine the presence or absence of total coliforms and E. coli for routine bacteriological monitoring at entry points or distribution system locations.

B. PMCLs for microbial contaminants.

1. A waterworks is in compliance with the PMCL for E. coli unless any of the conditions identified in this subdivision occur. A violation may pose an acute risk to public health and is a Tier 1 condition requiring public notification as described in 12VAC5-590-540 A 1 when:

a. A repeat sample following a total coliform-positive routine sample is E. coli positive;

b. A repeat sample following an E. coli-positive routine sample is total coliform positive;

c. The owner fails to collect all required repeat samples following an E. coli-positive routine sample; or

d. The owner fails to test for E. coli when any repeat sample tests positive for total coliform.

2. Compliance shall be determined with the PMCL for E. coli for each monitoring period for which monitoring for total coliforms is required.

C. The best available technology (BAT), treatment techniques, or other means available for achieving compliance with the PMCL for E. coli shall be:

1. Protection of wells from contamination by coliforms by appropriate placement, construction, and maintenance of the wells;

2. Maintenance of a detectable residual disinfectant throughout the distribution system;

3. Proper maintenance of the distribution system including appropriate pipe replacement and repair procedures, water main flushing programs, proper operation and maintenance of storage tanks and reservoirs, continual maintenance of positive water pressure in all parts of the distribution system, and an approved cross-connection control program;

4. Filtration and disinfection of a surface water source, a GUDI source, or both; and

5. Disinfection of groundwater using strong oxidants such as chlorine, chlorine dioxide, or ozone.

D. A total coliform-positive result is indicative of a breakdown in the protective barriers and shall be cause for repeat monitoring and special follow-up action to locate and eliminate the cause of contamination.

1. For each routine sample found to be total coliform positive, the owner shall collect a set of three repeat samples within 24 hours of being notified of the positive result. The department may extend the 24-hour limit on a case-by-case basis. For groundwater systems, the requirements of 12VAC5-590-379 shall also apply, and all repeat samples must be analyzed for E. coli using one of the analytical methods in 40 CFR 141.402(c).

a. The owner shall collect at least one repeat sample from the sampling tap where the original total coliform-positive sample was collected, and at least one repeat sample at a tap within five service connections upstream and at least one repeat sample at a tap within five service connections downstream of the original sampling site. If a total coliform-positive sample is at the end of the distribution system or one service connection away from the end of the distribution system, the owner must still collect all required repeat samples.

b. The owner shall collect an additional set of repeat samples if one or more repeat samples in the current set of repeat samples is total coliform positive. The owner shall collect the additional set of repeat samples within 24 hours of being notified of the positive results, unless the department extends the limit as provided in this section. The owner shall continue to collect additional sets of repeat samples until either total coliforms are not detected in one complete set of repeat samples or the owner determines that a coliform treatment technique trigger specified in 12VAC5-590-392 B has been exceeded as a result of a repeat sample being total coliform positive and notifies the department. If a trigger identified in 12VAC5-590-392 B is exceeded as a result of a routine sample being total coliform positive, then the owner is required to conduct only one round of repeat monitoring for each total coliform-positive routine sample.

c. If the owner collects a routine sample before learning the results of the previous routine sample, and the sample is collected within five service connections of the initial routine sample, then the owner may count the subsequent sample as a repeat sample when the initial sample results are found to be total coliform positive.

d. If one or more repeat samples collected at the monitoring location required for triggered source water monitoring are E. coli positive, then the owner has exceeded the E. coli PMCL and must comply with the groundwater system treatment technique requirements specified in 12VAC5-590-421.

e. If all repeat samples collected at the monitoring location required for triggered source water monitoring are E. coli negative, and a repeat sample collected at a monitoring location other than the one required for triggered source water monitoring is E. coli positive, then the owner has exceeded the E. coli PMCL. However, the owner is not required to collect five additional source water samples from the same source within 24 hours of learning the E. coli-positive result.

f. The owner shall collect all repeat samples on the same day, except the department may allow the owner of a waterworks with a single service connection to collect the required set of repeat samples over a three-day period or to collect a larger volume repeat sample in one or more sample containers of any size as long as the total volume collected is at least 300 ml.

g. If a repeat sample collected at the monitoring location required for triggered source water monitoring is E. coli-positive, then the owner has exceeded the E. coli PMCL and must collect five additional source water samples from the same source within 24 hours of learning the E. coli-positive result.

2. Results of all routine and repeat samples not invalidated by the department shall be used to determine compliance with the PMCL for E. coli and whether a treatment technique trigger specified in 12VAC5-590-392 B has been exceeded.

3. Special-purpose samples, such as those collected to determine whether disinfection practices are sufficient following pipe placement, replacement, or repair, and samples collected before start-up of a seasonal waterworks, shall not be used to determine compliance. Repeat samples are not considered special-purpose samples.

E. A total coliform-positive sample invalidated under this subsection does not count toward meeting the minimum monitoring requirements of this section. To invalidate a total coliform-positive sample under this subsection, the written decision and rationale shall be evaluated, approved, and signed by the department. The department shall make this document available to EPA and the public. The written documentation shall state the specific cause of the total coliform-positive sample and what action the owner has taken, or will take, to correct this problem. The department shall not invalidate a total coliform-positive sample solely on the grounds that all repeat samples are total coliform negative.

1. The department may invalidate a total coliform positive sample if any of the following conditions are met:

a. The laboratory establishes that improper sample analysis caused the total coliform-positive result;

b. The department, on the basis of the results of repeat samples collected as required by subdivision D 1 of this section, determines that the total coliform-positive sample resulted from a domestic or other nondistribution system plumbing problem. The department cannot invalidate a sample on the basis of repeat sample results unless all repeat samples collected at the same tap as the original total coliform-positive sample are also total coliform positive, and all repeat samples collected at a location other than the original tap are total coliform negative (e.g., the department cannot invalidate a total coliform-positive sample on the basis of repeat samples if all the repeat samples are total coliform negative or if the waterworks has only one service connection); or

c. The department has substantial grounds to believe that a total coliform-positive result is due to a circumstance or condition that does not reflect water quality in the distribution system. In this case, the owner shall still collect all repeat samples required under subdivision D 1 of this section, and use them to determine whether a coliform treatment technique trigger in 12VAC5-590-392 B has been exceeded.

2. A laboratory must invalidate a sample because of sampling interference (i.e., turbid culture in absence of (i) gas production, or (ii) acid reaction; exhibition of confluent growth; or production of colonies too numerous to count). The owner shall collect a replacement sample from the same location within 24 hours, and have it analyzed for the presence of total coliforms. The owner must continue to resample within 24 hours and have the samples analyzed until a valid result is obtained. The department may waive the 24-hour time limit on a case-by-case basis.

F. Escherichia coli (E. coli).

1. If a routine, repeat, or replacement sample is total coliform positive, then the owner shall analyze the total coliform-positive culture medium to determine if E. coli are present. If E. coli are present, then the owner shall notify the department by the end of the day when the owner is notified of the test result, unless the department is closed, in which case the department must be notified before the end of the next business day.

2. The department has the discretion to allow an owner, on a case-by-case basis, to forgo E. coli testing on a total coliform-positive sample if the owner assumes that the total coliform-positive sample is E. coli positive. Accordingly, the owner must notify the department as specified in subdivision F 1 of this subsection and the provisions of subdivision B 1 of this section apply.

G. Groundwater sources.

1. Groundwater sources shall be disinfected in accordance with 12VAC5-590-421 A 1 d when the results of the source water monitoring samples specified in 12VAC5-590-430 B 2 or 12VAC5-590-840 K 1 a indicate a total coliform concentration (geometric mean) of the 20 samples to be greater than 3 colonies/100 mL but less than 100 colonies/100 mL. The value 1.0 shall be used to represent a zero coliform result in the calculation of the geometric mean.

2. Groundwater source monitoring results conducted in accordance with 12VAC5-590-430 B 2 or 12VAC5-590-840 K 1 a that indicate a total coliform concentration equal to or greater than 100 colonies/100 ml constitutes contamination that is not treatable by single-barrier disinfection treatment alone.

3. Groundwater sources shall be disinfected in accordance the requirements of 12VAC5-590-421 A 1 d when the source water quality contributes to the waterworks' failure to meet the bacteriological PMCL specified in subsection B of this section.

4. If the results of the source water monitoring required by 12VAC5-590-379 C or 12VAC5-590-430 B 2 indicate the presence of E. coli in two or more samples collected during any running six-month period, then the owner shall:

a. Issue a Tier 1 public notice in accordance with 12VAC5-590-540 A 1.

b. Provide disinfection treatment to achieve a 4-log virus inactivation and removal as specified in 12VAC5-590-421 A 1 d.

c. Conduct compliance monitoring as specified in 12VAC5-590-421 B and 12VAC5-590-421 C.

5. If the results of the source water monitoring required in 12VAC5-590-379 C indicate total coliform concentration in excess of 50 colonies/100 mL in three or more samples collected during any running six-month period or the presence of E. coli in two or more samples collected during any running six-month period, then the source water shall be reevaluated for GUDI determination in accordance with 12VAC5-590-430.

6. The department may require that any groundwater source be disinfected in accordance with the requirements of 12VAC5-590-421 A 1 d.

H. All samples shall be analyzed by laboratories that have received certification by EPA or DCLS as specified in 12VAC5-590-440 for drinking water analyses.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-004.05 § 2.5, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 19, Issue 24, eff. September 10, 2003; Volume 28, Issue 5, eff. December 7, 2011; Volume 33, Issue 3, eff. November 2, 2016; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-382 Inorganic chemicals compliance

A. When the results of sampling for antimony, arsenic, asbestos, barium, beryllium, cadmium, cyanide (as free cyanide), chromium, fluoride, mercury, nickel, selenium, or thallium exceed the applicable PMCL, the owner shall collect a confirmation sample at the same sampling point within two weeks of notification of the analytical results of the first sample. The fluoride PMCL applies only to community waterworks.

1. The results of the initial and confirmation samples shall be averaged to determine compliance with subsection A of this section. The department has the discretion to delete results of obvious sampling errors.

2. Compliance with the PMCLs for antimony, arsenic, asbestos, barium, beryllium, cadmium, cyanide (as free cyanide), chromium, fluoride, mercury, nickel, selenium, and thallium listed in Table 340.1 shall be determined based on the analytical results obtained at each sampling point.

a. For the owner of a waterworks that conducts monitoring more frequently than annually, compliance with the PMCL for antimony, arsenic, asbestos, barium, beryllium, cadmium, cyanide (as free cyanide), chromium, fluoride, mercury, nickel, selenium, or thallium is determined by an RAA at each sampling point. If the average at any sampling point is greater than the PMCL, then the waterworks is out of compliance. If any single sample would cause the annual average to be exceeded, then the waterworks is out of compliance immediately. A sample result below the MDL shall be calculated as zero for the purpose of determining the annual average. If the owner fails to collect the required number of samples, compliance (average concentration) shall be based on the total number of samples collected.

b. For the owner of a waterworks that monitors annually or less frequently, the waterworks is not out of compliance with the PMCL for antimony, arsenic, asbestos, barium, beryllium, cadmium, cyanide (as free cyanide), chromium, fluoride, mercury, nickel, selenium, or thallium if the average of the original sample and a confirmation sample of a contaminant at any sampling point is greater than the PMCL. If sample results for the owner monitoring annually or less frequently exceed the PMCL, the owner shall begin quarterly sampling. The owner shall not be considered in violation of the PMCL until one year of quarterly sampling has been completed and the RAA is exceeded. However, if the confirmation sample is not collected, the owner is in violation of the PMCL for antimony, arsenic, asbestos, barium, beryllium, cadmium, cyanide (as free cyanide), chromium, fluoride, mercury, nickel, selenium, or thallium. If the owner fails to collect the required number of samples, then compliance (average concentration) shall be based on the total number of samples collected.

B. Compliance with the PMCLs for nitrate and nitrite shall be determined based on the analytical results obtained at each sampling point. The waterworks is not out of compliance with the PMCL if the concentrations of these contaminants are equal to or below the PMCLs. Where nitrate or nitrite sample results exceed the PMCL, the owner shall collect a confirmation sample, from the same sampling point that exceeded the PMCL within 24 hours of the owner's receipt of the analytical results of the first sample. The results of the initial and confirmation sample shall be averaged to determine compliance. The owner unable to comply with the 24-hour sampling requirement shall immediately notify the consumers in the area served by the waterworks in accordance with 12VAC5-590-540 A 1. The owner exercising this option shall collect and analyze a confirmation sample within two weeks of notification of the analytical results of the first sample. The department may require more frequent monitoring. The department has the discretion to delete results of obvious sampling errors.

1. Nitrate nitrogen (NO₃-N) levels not exceeding 20 mg/L may be allowed in a noncommunity waterworks if the owner:

a. Demonstrates to the satisfaction of the department that this water will not be available to children under six months of age;

b. Provides continuous posting of the fact that NO₃-N levels exceed 10 mg/L and the potential health effects of exposure;

c. Notifies health officials annually of NO₃-N levels that exceed 10 mg/L; and

d. The department shall determine that no adverse health effects will result.

2. Nitrite in water poses a significant health hazard. Water with nitrite-nitrogen concentrations over 1 mg/L should not be used for infant feedings.

C. Compliance with the SMCLs for aluminum, chloride, copper, corrosivity, fluoride, foaming agents, iron, manganese, silver, sulfate, or zinc shall be determined based on the analytical results obtained at each sampling point. When the result of a sample exceeds the applicable SMCL, the owner shall collect a confirmation sample at the same sampling point within two weeks of notification of the analytical results of the first sample. The results of the initial and confirmation samples shall be averaged to determine compliance. If the average concentration level of any of these constituents exceeds the SMCL, then the department shall determine whether treatment for the constituents can be accomplished or more suitable source waters are, or can be made, available. This determination shall be made as quickly as possible. If either of these alternatives is feasible, then corrective action shall be promptly implemented by the owner if deemed necessary by the department. Exceeding the fluoride SMCL requires annual public notice in accordance with 12VAC5-590-540 G.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-383 Organic chemicals compliance

A. When the results of sampling indicate positive results for contaminants listed in Table 340.2, the owner shall collect a confirmation sample at the same sampling point within two weeks of notification of the analytical results of the first sample.

B. The results of the initial and confirmation samples shall be averaged to determine waterworks compliance in accordance with subsection C of this section. The department has the discretion to delete results of obvious sampling errors.

C. Compliance with Table 340.2 shall be determined based on the analytical results obtained at each sampling point. A sample result below the detection limit shall be calculated as zero for the purposes of determining the annual average. If the owner fails to collect the required number of samples, then compliance (average concentration) shall be based on the total number of samples collected.

1. For the owner of a waterworks that conducts monitoring more frequently than annually, compliance is determined by an RAA of all samples collected at each sampling point. If the annual average of any sampling point is greater than the PMCL, then the waterworks is out of compliance. If the initial sample or a subsequent sample would cause the annual average to be exceeded, then the waterworks is out of compliance immediately. A sample result below the detection limit shall be calculated as zero for purposes of determining the annual average.

2. If the owner is conducting monitoring annually or less frequently, then the owner is not in violation if the average of the initial and confirmation samples is greater than the PMCL for that contaminant; however, the owner shall begin quarterly sampling. The owner will not be considered in violation of the PMCL until one year of quarterly sampling has been completed and the RAA is exceeded. If any sample will cause the RAA to exceed the PMCL at any sampling point, then the waterworks is immediately out of compliance with the PMCL.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-384 Residual disinfectant, DBPs, and DBPPs compliance

A. General requirements.

1. Where compliance is based on an RAA of monthly or quarterly samples or averages and the owner fails to monitor for TTHM, HAA5, or bromate, this failure to monitor shall be treated as a monitoring violation for the entire period covered by the annual average. Where compliance is based on an RAA of monthly or quarterly samples or averages and the owner's failure to monitor makes it impossible to determine compliance with MRDLs for chlorine and chloramines, this failure to monitor shall be treated as a monitoring violation for the entire period covered by the annual average.

2. All samples collected and analyzed under the provisions of this section shall be included in determining compliance, even if that number is greater than the minimum required.

3. The owner is in violation of the PMCL when the LRAA exceeds the PMCLs listed in Table 340.6 calculated based on four consecutive quarters of monitoring, or the LRAA calculated based on fewer than four quarters of data if the PMCL would be exceeded regardless of the monitoring results of subsequent quarters. The owner is in violation of the monitoring requirements for each quarter that a monitoring result would be used in calculating the LRAA if the owner fails to monitor.

B. Disinfection byproducts.

1. TTHM and HAA5.

a. The owner of a waterworks required to monitor quarterly shall calculate the LRAAs for TTHM and HAA5 using monitoring results collected under 12VAC5-590-374 F and determine that each LRAA does not exceed the PMCL in order to comply with the PMCLs listed in Table 340.6. If the owner fails to complete four consecutive quarters of monitoring, then the owner shall calculate compliance with the PMCL based on the average of the available data from the most recent four quarters. If the owner collects more than one sample per quarter at a monitoring location, then the owner shall average all samples collected in the quarter at that location to determine a quarterly average to be used in the LRAA calculation.

b. The owner of a waterworks required to monitor annually or less frequently shall determine that each sample collected is less than the PMCL in order to determine compliance with the PMCLs listed in Table 340.6. If any sample result exceeds the PMCL, then the owner shall comply with the requirements of 12VAC5–590-374 F 5. If no sample result exceeds the PMCL, then the sample result for each monitoring location is considered the LRAA for that monitoring location.

c. The owner is in violation of the monitoring requirements for each quarter that a monitoring result would be used in calculating an LRAA if the owner fails to monitor.

d. A waterworks has exceeded the operational evaluation level at any monitoring location where the sum of the two previous quarters' TTHM results plus twice the current quarter's TTHM result, divided by four to determine an average, exceeds 0.080 mg/L, or where the sum of the two previous quarters' HAA5 results plus twice the current quarter's HAA5 result, divided by four to determine an average, exceeds 0.060 mg/L.

(1) The owner of a waterworks that exceeds the operational evaluation level shall conduct an operational evaluation and submit a written report of the evaluation to the department on a form approved by the department no later than 90 days after being notified of the analytical result that caused the waterworks to exceed the operational evaluation level. The written report shall be made available to the public upon request.

(2) The operational evaluation report shall include an examination of the waterworks treatment and distribution operational practices, including source water conditions, storage tank operations, excess storage capacity, distribution system flushing, changes in source water or source water quality, and treatment changes or problems that may contribute to TTHM and HAA5 formation and what steps could be considered to minimize future exceedances.

(3) The owner may request and the department may allow the owner to limit the scope of the evaluation if the owner is able to identify the cause of the operational evaluation level exceedance. The request to limit the scope of the evaluation does not extend the schedule in subdivision B 1 d (1) of this section for submitting the written report. The department shall approve this limited scope of evaluation in writing, and the owner shall keep that approval with the completed report.

2. Bromate. Compliance shall be based on a running annual arithmetic average, computed quarterly, of monthly samples collected by the owner as prescribed by 12VAC5-590-374 H. For months in which the owner collects more than one sample, compliance is based on the average of all samples collected during the month. If the average result of the samples covering any consecutive four-quarter period exceeds the PMCL listed in Table 340.6, then the owner is in violation of the PMCL and shall notify the public pursuant to 12VAC5-590-540 A 2, in addition to reporting to the department pursuant to 12VAC5-590-530 and 12VAC5-590-531. If the owner fails to complete 12 consecutive months of monitoring, then compliance with the PMCL for the last four-quarter compliance period shall be based on the average of the available data.

3. Chlorite. Compliance shall be based on an arithmetic average of each three-sample set collected in the distribution system as prescribed by 12VAC5-590-374 G. If the arithmetic average of any three-sample set exceeds the PMCL listed in Table 340.6, then the owner is in violation of the PMCL and shall notify the public pursuant to 12VAC5-590-540 A 2, in addition to reporting to the department pursuant to 12VAC5-590-530 and 12VAC5-590-531.

C. Residual disinfectant.

1. Chlorine and chloramines.

a. Compliance shall be based on a running annual arithmetic average, computed quarterly, of monthly averages of all samples collected by the owner under 12VAC5-590-374 I 1 a. If the average covering any consecutive four-quarter period exceeds the MRDL listed in Table 340.7, then the owner is in violation of the MRDL and shall notify the public pursuant to 12VAC5-590-540 A 2, in addition to reporting to the department pursuant to 12VAC5-590-530 and 12VAC5-590-531.

b. In cases where the owner switches between the use of chlorine and chloramines for residual disinfection during the year, compliance shall be determined by including together all monitoring results of both chlorine and chloramines in calculating compliance. Reports submitted pursuant to 12VAC5-590-530 and 12VAC5-590-531 shall clearly indicate which residual disinfectant was analyzed for each sample.

c. Notwithstanding the MRDLs listed in Table 340.7, operators may increase the residual disinfectant levels of chlorine or chloramines in the distribution system to a level and for a time necessary to protect public health to address specific microbiological contamination problems caused by circumstances such as water main breaks in the distribution system, storm runoff events, source water contamination, or cross-connections.

2. Chlorine dioxide.

a. Acute violations. Compliance shall be based on consecutive daily samples collected by the owner under 12VAC5-590-374 I 2 a. If any daily sample collected at the entrance to the distribution system exceeds the MRDL listed in Table 340.7, and on the following day one or more of the three samples collected in the distribution system exceed the MRDL, then the owner is in violation of the MRDL and shall take immediate corrective action to lower the level of chlorine dioxide below the MRDL and shall notify the public pursuant to the procedures for Tier 1 conditions in 12VAC5-590-540 A 1 in addition to reporting to the department pursuant to 12VAC5-590-530 and 12VAC5-590-531. Failure to collect samples in the distribution system the day following an exceedance of the chlorine dioxide MRDL at the entrance to the distribution system shall also be considered an MRDL violation, and the owner shall notify the public of the violation in accordance with the provisions for Tier 1 conditions in 12VAC5-590-540 A 1 in addition to reporting to the department pursuant to 12VAC5-590-530 and 12VAC5-590-531.

b. Nonacute violations. Compliance shall be based on consecutive daily samples collected by the owner under 12VAC5-590-374 I 2 a. If any two consecutive daily samples collected at the entrance to the distribution system exceed the MRDL listed in Table 340.7 and all distribution system samples collected are below the MRDL, then the owner is in violation of the MRDL and shall take corrective action to lower the level of chlorine dioxide below the MRDL at the point of sampling and shall notify the public pursuant to the procedures for Tier 2 conditions in 12VAC5-590-540 A 2 in addition to reporting to the department pursuant to 12VAC5-590-530 and 12VAC5-590-531. Failure to monitor at the entrance to the distribution system the day following an exceedance of the chlorine dioxide MRDL at the entrance to the distribution system is also an MRDL violation, and the owner shall notify the public of the violation in accordance with the provisions for Tier 2 conditions in 12VAC5-590-540 A 2 in addition to reporting to the department pursuant to 12VAC5-590-530 and 12VAC5-590-531.

D. Disinfection byproduct precursors (DBPPs).

1. Compliance shall be determined as specified by 12VAC5-590-411 A 3.

2. For the owner required to meet Step 1 TOC removals, if the value calculated under 12VAC5-590-411 A 3 a (4) is less than 1.00, then the owner is in violation of the treatment technique requirements and shall notify the public pursuant to 12VAC5-590-540 A 2 in addition to reporting to the department pursuant to 12VAC5-590-530 and 12VAC5-590-531.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-385 Lead and copper AL compliance

A. The lead AL is exceeded if the concentration of lead in more than 10% of tap water samples collected during any monitoring period conducted in accordance with 12VAC5-590-375 B is greater than 0.015 mg/L (i.e., if the 90th percentile lead level is greater than 0.015 mg/L).

B. The copper AL is exceeded if the concentration of copper in more than 10% of tap water samples collected during any monitoring period conducted in accordance with 12VAC5-590-375 B is greater than 1.3 mg/L (i.e., if the 90th percentile copper level is greater than 1.3 mg/L).

C. The 90th percentile lead and copper levels shall be computed as follows:

1. The results of all lead or copper samples taken during a monitoring period shall be placed in ascending order from the sample with the lowest concentration to the sample with the highest concentration. Each sampling result shall be assigned a number, ascending by single integers beginning with the number 1 for the sample with the lowest contaminant level. The number assigned to the sample with the highest contaminant level shall be equal to the total number of samples taken.

2. The number of samples taken during the monitoring period shall be multiplied by 0.9.

3. The contaminant concentration in the numbered sample yielded by the calculation in subdivision C 2 of this section is the 90th percentile contaminant level.

4. For a waterworks serving fewer than 100 people, and the owner collects five samples per monitoring period, the 90th percentile is computed by taking the average of the highest and second highest concentrations.

5. For the owner that has been allowed by the department to collect fewer than five samples in accordance with 12VAC5-590-375 B 3, the sample result with the highest concentration is considered the 90th percentile value.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 27, Issue 1, eff. October 13, 2010; amended, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-388 Radiological compliance

A. MCLGs for radionuclides are listed in Table 546.1 of 12VAC5-590-546 B.

B. PMCLs for radionuclides are applicable to community waterworks only and are listed in Table 340.4. Compliance with PMCLs will be determined based on the analytical results obtained at each entry point. If the sample result at one entry point exceeds the PMCL, then the owner is in violation of the PMCL.

1. For the owner that is monitoring more than once per year, compliance with the PMCL is determined by an RAA of the analytical results at each entry point. If the average result at any entry point is greater than the PMCL, then the waterworks is out of compliance with the PMCL.

2. For the owner of a waterworks that monitors more than once per year, if any sample result will cause the RAA to exceed the PMCL at any entry point, then the waterworks is out of compliance with the PMCL immediately.

3. All samples collected and analyzed under the provisions 12VAC5-590-378 shall be included in determining compliance, even if that number is greater than the minimum required.

4. If the owner does not collect all required samples when compliance is based on an RAA result of quarterly samples, then compliance will be based on the RAA result of the samples collected.

5. If a sample result is less than the detection limit as specified in Table 378.1, then zero will be used to calculate the RAA unless a gross alpha particle activity result is being used instead of radium-226 or uranium. If the gross alpha particle activity result is less than the detection limit as specified in Table 378.1, then one half the detection limit will be used to calculate the RAA.

C. Radiological (gross alpha, combined radium-226 and radium-228, uranium, and man-made radioactivity).

1. Compliance with the radiological PMCLs shall be based on the RAA results. PMCLs are indicated in Table 340.4. Sampling for radiological analysis shall be in compliance with 12VAC5-590-378.

2. Compliance shall be determined by rounding off results to the same number of significant figures as the PMCL for the radionuclide in question.

D. If a PMCL for radioactivity listed in Table 340.4 is exceeded, then the owner shall give notice to the department pursuant to 12VAC5-590-530 and to the public as required by 12VAC5-590-540 A 2.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-390 Physical constituent compliance

A. Color, odor, pH, and total dissolved solids.

1. When the sampling results for color, odor, pH, or total dissolved solids exceed the applicable SMCL, the owner shall collect a confirmation sample at the same sampling site within two weeks of notification of the analytical results of the first sample.

2. The results of the initial and confirmation samples shall be averaged to determine compliance with 12VAC5-590-340 C. The department has the discretion to void results of obvious sampling errors.

3. If the average concentration level of any contaminant of color, odor, pH, or total dissolved solids is greater than the SMCL listed in Table 340.3, then the department shall determine whether treatment to remove that contaminant can be accomplished or more suitable supplies of source water are, or can be made, available.

B. Turbidity in groundwater sources not required to filter shall not:

1. Interfere with disinfection throughout the distribution system;

2. Cause taste and odors upon disinfection; or

3. Cause consumers to question the safety of their drinking water.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-004.06 § 2.6, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 12, Issue 2, eff. November 15, 1995; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-391 Treatment technique requirements

A. When it is not technically or economically feasible to monitor for a particular PMCL or a contaminant, one or more specific treatment techniques that lead to a reduction in the concentration level of that contaminant shall be required. The application of that treatment technique reduces the contaminant in question to a concentration level that achieves compliance with this chapter.

B. Failure to continuously maintain the treatment technique is a violation of this chapter and public notification in accordance with 12VAC5-590-540 A 2 is required.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-392 Coliform treatment technique triggers and assessment requirements

A. Assessments shall be conducted in accordance with subsections C, D, and E of this section after exceeding treatment technique triggers.

B. Treatment technique triggers.

1. Level 1 treatment technique triggers:

a. For the owner required to collect 40 or more samples per month, the number of total coliform-positive samples exceeds 5.0% of the number of samples collected for the month.

b. For the owner required to collect fewer than 40 samples per month, when there are two or more total coliform-positive samples in the same month.

c. The owner fails to collect every required repeat sample after any single total coliform-positive sample.

2. Level 2 treatment technique triggers:

a. An E. coli PMCL violation, as specified in 12VAC5-590-380 B 2.

b. A second Level 1 trigger occurs within a rolling 12-month period, unless the department has determined a likely reason for the first Level 1 treatment technique trigger and that the owner has corrected the problem.

C. Assessment requirements.

1. Level 1 and 2 assessments shall be conducted to identify the possible presence of sanitary defects and defects in the distribution system coliform monitoring practices. The owner shall be responsible for conducting Level 1 assessments. Level 2 assessments shall be conducted by the department.

2. When conducting Level 1 and Level 2 assessments, the assessor shall include:

a. An evaluation and identification of inadequacies in sample sites, sampling protocol, and sample processing;

b. An evaluation of atypical events that could affect distributed water quality or indicate that distributed water quality was impaired;

c. An evaluation of changes in distribution system maintenance and operation that could affect distributed water quality, including water storage;

d. An evaluation of source and treatment considerations that impact distributed water quality; and

e. An evaluation of existing water quality monitoring data.

3. Level 1 assessment.

a. The owner shall complete the assessment and document the assessment on a form approved by the department. The owner shall submit the assessment form, as soon as practical, but within 30 days after the owner learns that a trigger in subdivision B 1 of this section has been exceeded.

b. If the department evaluates the completed Level 1 assessment and determines that the assessment is not sufficient, including any proposed timetable for any corrective actions, then the department shall consult with the owner. If the department requires revisions after the consultation, then the owner shall submit a revised assessment form to the department on an agreed upon schedule not to exceed 30 days from the date of consultation.

c. Upon completion and submission of the assessment form by the owner, the department shall determine if the owner has identified a likely cause for the Level 1 trigger and, if so, confirm that the owner has corrected the problem or has included a schedule acceptable to the department for correcting the problem.

4. Level 2 assessment.

a. The department will complete the assessment and document the assessment on a form approved by the department. The department will consult with the owner during the assessment and complete the assessment within 30 days upon learning that the waterworks has exceeded any trigger in subdivision B 2 of this section.

b. The department will send to the owner the completed assessment form, which will describe any detected sanitary defects, corrective actions completed or needed and, if needed, a timetable to complete the corrective actions. The owner will return the form within seven days with a signature that indicates concurrence with the listed actions needed and timetable to complete the corrective actions. If the owner does not concur with either an action or timetable to complete a corrective action, then the owner shall notify the department, complete consultation with the department, and develop a revised corrective action schedule. The owner shall submit the revised schedule to the department for evaluation and approval within 30 days of the date of the consultation.

D. Corrective actions.

1. The owner shall correct sanitary defects found through either the Level 1 or the Level 2 assessment conducted under subsection C of this section.

2. The owner shall complete the corrective actions in compliance with the timetable approved by the department in consultation with the owner. The owner shall notify the department no later than seven days after each scheduled corrective action is completed.

E. Consultation.

1. At any time during the assessment or corrective action phase, either the owner or the department may request a consultation with the other party to determine the appropriate actions to be taken.

2. The owner may consult with the department on all relevant information that may impact the ability to comply with subsection D of this section.

F. Violations. Failure to conduct the required assessment or corrective actions in accordance with subsections C and D of this section, after exceeding a treatment technique trigger specified in subsection B of this section, is a treatment technique violation. The owner shall provide public notification as required under Tier 2 conditions specified in 12VAC5-590-540 A 2.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 33, Issue 3, eff. November 2, 2016; amended, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-395 Surface water and GUDI sources, polymers, and recycle treatment techniques

A. Surface water and GUDI source treatment techniques.

1. The filtration and disinfection provisions of this section are required treatment techniques for a waterworks supplied by a surface water source, a GUDI source, or both. These treatment technique requirements are in place of a PMCL for the following contaminants: Giardia lamblia, viruses, heterotrophic bacteria, Cryptosporidium, Legionella, and turbidity. A waterworks that uses a surface water source, a GUDI source, or both shall provide treatment of that source water that complies with these treatment technique requirements. See 12VAC5-590-401 for filtration log removal credits and required log inactivation for Cryptosporidium. See 12VAC5-590-500 for log removal credits and required log inactivation for Giardia lamblia and viruses. These treatment technique requirements consist of installing and properly operating water treatment processes that reliably achieve:

a. At least 99.9% (3-log) removal or inactivation of Giardia lambliabetween a point where the source water is not subject to recontamination by surface water runoff and a point downstream before or at the first customer;

b. At least 99.99% (4-log) removal or inactivation of viruses between a point where the source water is not subject to recontamination by surface water runoff and a point downstream before or at the first customer; and

c. At least 99% (2-log) removal of Cryptosporidium between a point where the source water is not subject to recontamination by surface water runoff and a point downstream before or at the first customer.

2. A waterworks that uses a surface water source, a GUDI source, or both is considered to be in compliance with the requirements of subdivision A 1 of this section if it meets the following disinfection and filtration requirements:

a. Disinfection requirements.

(1) The disinfection treatment shall be sufficient to ensure that the total treatment processes of that waterworks achieve at least 99.9% (3-log) inactivation or removal of Giardia lamblia and at least 99.99% (4-log) inactivation or removal of viruses. If any physical process can achieve at least a 3-log removal of Giardia lamblia but cannot adequately remove pathogens, then the disinfection treatment shall provide a second treatment barrier for Giardia lamblia, Legionella, heterotrophic bacteria, and viruses. The disinfection treatment shall be sufficient to assure at least a 0.5 log inactivation of Giardia lamblia.

(2) The residual disinfectant concentration in the water entering the distribution system shall not be less than 0.2 mg/L for more than four hours.

(3) The residual disinfectant concentration in the distribution system, measured as total chlorine, free chlorine, combined chlorine, or chlorine dioxide, shall not be undetectable in more than 5% of the samples each month, for any two consecutive months that the waterworks serves water to the public. If the department determines that a waterworks is experiencing excessive coliform occurrences in its distribution system, then the department may require the owner to maintain minimum chlorine residual levels of 0.2 mg/L or monochloramine levels of 0.5 mg/L throughout the distribution system. Water in the distribution system with a heterotrophic bacteria concentration less than or equal to 500/mL, measured as HPC, is deemed to have a detectable residual disinfectant for the purposes of determining compliance with this requirement. Thus, the value "V," in percent, in the following formula shall not exceed 5% in one month, for any two consecutive months.

V = [(c + d + e) / (a + b)] X 100

where

a = number of instances where the residual disinfectant concentration is measured;

b = number of instances where the residual disinfectant concentration is not measured but HPC is measured;

c = number of instances where the residual disinfectant concentration is measured but not detected and no HPC is measured;

d = number of instances where no residual disinfectant concentration is detected and where the HPC is greater than 500/mL; and

e = number of instances where the residual disinfectant concentration is not measured and HPC is greater than 500/mL.

(4) The department may determine that the HPC compliance requirements of subdivision A 2 a (3) of this section do not apply based on site-specific considerations or if an owner has no means for having a sample transported and analyzed for HPC by a certified laboratory under the requisite time and temperature conditions and the waterworks is providing adequate disinfection in the distribution system.

b. Filtration requirements. A waterworks that uses a surface water source, a GUDI source, or both shall provide filtration treatment by using one of the following methods:

(1) Conventional filtration.

(a) Achieve a filtered water turbidity of less than or equal to 0.3 NTU in at least 95% of the measurements taken each month. Samples shall be representative of the waterworks' filtered water.

(b) The turbidity level of representative samples of a waterworks' filtered water shall at no time exceed one NTU, measured as specified in 12VAC5-590-440.

(c) A waterworks that uses lime softening may acidify representative samples before analysis using a protocol approved by the department.

(d) Water treatment plants utilizing conventional or direct filtration with gravity flow granular media filters are capable of producing filtered water with turbidity consistently less than 0.10 NTU. Therefore, for these types of water treatment plants, the operational goal for filter effluent turbidity for each filter, before any post-filtration chemical addition, shall be 0.10 NTU.

(2) Diatomaceous earth filtration.

(a) The turbidity level of representative samples of a waterworks' filtered water shall be less than or equal to one NTU in at least 95% of the measurements taken each month.

(b) The turbidity level of representative samples of a waterworks' filtered water shall at no time exceed five NTU.

(3) Slow sand filtration.

(a) The turbidity level of representative samples of a waterworks' filtered water shall be less than or equal to one NTU in at least 95% of the measurements taken each month, except that if the department determines there is no significant interference with disinfection at a higher turbidity level, then the department may substitute this higher turbidity limit for that waterworks.

(b) The turbidity level of representative samples of a waterworks' filtered water shall at no time exceed five NTU.

(4) Membrane filters, bag filters, and cartridge filters.

(a) The turbidity level of representative samples of a waterworks' filtered water shall be less than or equal to 0.3 NTU in at least 95% of the measurements taken each month, except that if the department determines there is no significant interference with disinfection at a higher turbidity level, then the department may substitute this higher turbidity limit for that waterworks.

(b) Water treatment plants utilizing membrane filtration are capable of producing filtered water with turbidity consistently less than 0.05 NTU. Therefore, for these types of water treatment plants, the operational goal for filter effluent turbidity for each filter, before any post-filtration chemical addition, is 0.05 NTU.

(c) The turbidity level of representative samples of a waterworks' filtered water shall at no time exceed one NTU.

(5) The owner may use a filtration technology not listed in this section if the owner demonstrates to the satisfaction of the department by full-scale, pilot plant, or challenge studies, or by other approved means that the alternative filtration technology, in combination with disinfection, will meet the requirements of this section.

3. Once the department has determined that a waterworks utilizes a surface water source, a GUDI source, or both (see 12VAC5-590-430), then filtration and disinfection treatments are required. The owner shall install and have in operation treatment units that meet the requirements described in subdivisions A 1 and A 2 of this section no later than 18 months following the department's determination. During the interim period, and until filtration and disinfection treatments are installed and in operation, the owner shall discontinue use of the surface water source, GUDI source, or both unless the source must remain in service because discontinuing the source is not a viable option, at which point the owner shall:

a. Issue a continuous boil water notice through the public notification procedure in 12VAC5-590-540 A 1 until the required filtration and disinfection treatments are installed and are in operation;

b. Provide disinfection treatment to achieve a 4-log inactivation of virus during the interim period before the filtration treatment is installed. Monitoring equipment shall be installed that will ensure compliance with this requirement; and

c. Increase bacteriological sampling frequency in the distribution system. For the owner required to collect routine distribution system bacteriological samples at a monthly frequency, the owner shall collect twice the number of samples required for that population each month. For the owner required to collect routine bacteriological samples at a quarterly frequency, the owner shall increase the sampling frequency to monthly.

B. Polymer treatment techniques.

1. The owner shall certify annually in writing to the department (using third-party or manufacturer's certification) that, when polymers containing acrylamide or epichlorohydrin are used by the waterworks, the combination (or product) of dose and monomer level does not exceed the following specified levels:

a. Acrylamide = 0.05% dosed at one ppm (or equivalent) of polymer.

b. Epichlorohydrin = 0.01% dosed at 20 ppm (or equivalent) of polymer.

2. Certifications may rely on the manufacturers or third parties as approved by the department.

C. Recycle treatment techniques.

1. If spent filter backwash water, thickener supernatant, or liquids from dewatering processes are recycled, in a waterworks supplied by a surface water source, a GUDI source, or both that employ conventional filtration or direct filtration treatment, then the waterworks is subject to the treatment technique requirement described in subsection A of this section.

2. Under this requirement, recycle flows shall be returned through all the processes of the treatment system or an alternative location approved by the department.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-400 (Repealed.)

History

• Historical Notes: Derived from VR355-18-004.07 § 2.7, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 12, Issue 2, eff. November 15, 1995; Volume 19, Issue 24, eff. September 10, 2003; Volume 22, Issue 15, eff. May 3, 2006; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-401 Enhanced filtration and disinfection for Cryptosporidium treatment techniques

A. A waterworks using a surface water source, a GUDI source, or both shall comply with the requirements of this section based on their population or if the waterworks is a wholesaler, based on the population of the largest waterworks in the combined distribution system.

B. The owner shall conduct an initial and a second round of source water monitoring for each water treatment plant that treats a surface water source, a GUDI source, or both. This monitoring may include sampling for Cryptosporidium, E. coli, and turbidity to determine what level, if any, of additional Cryptosporidium treatment is required.

1. Initial round of source water monitoring. The owner shall conduct the following monitoring on the schedule in subdivision B 3 of this section unless the monitoring avoidance criteria in subdivision B 4 of this section are met.

a. The owner of a waterworks serving at least 10,000 people shall sample the source water for Cryptosporidium, E. coli, and turbidity at least monthly for 24 months.

b. The owner of a waterworks serving fewer than 10,000 people:

(1) Shall sample the source water for E. coli at least once every two weeks for 12 months, or

(2) May avoid E. coli monitoring if the owner notifies the department that the owner will monitor for Cryptosporidium as described in subdivision B 1 c of this section. The owner shall notify the department no later than three months before the date at which the owner is otherwise required to start E. coli monitoring.

c. The owner of a waterworks serving fewer than 10,000 people shall sample the source water for Cryptosporidium at least twice per month for 12 months or at least monthly for 24 months if the owner meets one of the following, based on monitoring conducted under subdivision B 1 b of this section:

(1) For a waterworks using source water from a lake or reservoir, the annual mean E. coli concentration is greater than 10 E. coli/100 mL.

(2) For a waterworks using source water from flowing stream, the annual mean E. coli concentration is greater than 50 E. coli/100 mL.

(3) The waterworks does not conduct E. coli monitoring as described in subdivision B 1 b of this section.

(4) The waterworks using a GUDI source shall comply with the requirements of this subdivision B 1 c based on the E. coli level that applies to the nearest surface water body. If no surface water body is nearby, the waterworks shall comply based on the requirements that apply to a waterworks using source water from a lake or reservoir.

d. For the waterworks serving fewer than 10,000 people, the department may approve monitoring for an indicator other than E. coli under subdivision B 1 b (1) of this section. The department also may approve an alternative to the E. coli concentration in subdivision B 1 c (1), B 1 c (2), or B 1 c (4) of this section to trigger Cryptosporidium monitoring. This approval by the department shall be provided to the owner in writing and shall include the basis for the department's determination that the alternative indicator or trigger level will provide a more accurate identification of whether a waterworks will exceed the Bin 1 Cryptosporidium level in subdivision B 1 a of this section.

e. The waterworks may sample more frequently than required under this section if the sampling frequency is evenly spaced throughout the monitoring period.

2. Second round of source water monitoring. The owner shall conduct a second round of source water monitoring that meets the requirements for monitoring parameters, frequency, and duration described in subdivision B 1 of this section, unless the monitoring exemption criteria in subdivision B 4 of this section are met. The owner shall conduct this monitoring on the schedule in subdivision B 3 of this section.

3. Monitoring schedule. The owner shall begin the monitoring required in subdivisions B 1 and B 2 of this section no later than the month beginning with the date listed in Table 401.1:

| TABLE 401.1 Source Water Monitoring Starting Dates | | | | --- | --- | --- | | OWNERS OF WATERWORKS THAT SERVE... | SHALL BEGIN THE FIRST ROUND OF SOURCE WATER MONITORING NO LATER THAN THE MONTH BEGINNING... | AND SHALL BEGIN THE SECOND ROUND OF SOURCE WATER MONITORING NO LATER THAN THE MONTH BEGINNING... | | At least 100,000 people | October 1, 2006 | April 1, 2015 | | From 50,000 - 99,999 people | April 1, 2007 | October 1, 2015 | | From 10,000 - 49,999 people | April 1, 2008 | October 1, 2016 | | Fewer than 10,000 and monitor for E. coli | October 1, 2008 | October 1, 2017 | | Fewer than 10,000 and monitor for Cryptosporidium^a | April 1, 2010 | April 1, 2019 | | ^aApplies to a waterworks that meet the conditions of subdivision B 1 c of this section. | | |

4. Monitoring avoidance.

a. The owner is not required to conduct source water monitoring if the waterworks will provide a total of at least 5.5-log of treatment for Cryptosporidium, equivalent to meeting the treatment requirements of Bin 4 in subdivision D 2 of this section.

b. If the owner chooses to provide the level of treatment in subdivision B 4 a of this section, rather than start source water monitoring, then the owner shall notify the department in writing no later than the date the owner is otherwise required to submit a sampling schedule for monitoring under subdivision B 5 of this section. Alternatively, the owner may choose to stop sampling at any point after initiating monitoring if the owner notifies the department in writing that he will provide this level of treatment. The owner shall install and operate technologies to provide this level of treatment by the applicable treatment compliance date in subdivision D 3 of this section.

5. Sampling schedules.

a. The owner of a waterworks required to conduct source water monitoring in accordance with subsection B of this section shall submit a sampling schedule that specifies the calendar dates when the owner shall collect each required sample.

(1) The owner shall submit a sampling schedule to the department no later than three months before the applicable date listed in subdivision B 3 of this section for each round of required monitoring.

(2) If the department does not respond to the owner regarding the sampling schedule, then the owner shall sample at the reported schedule.

b. The owner shall collect samples within two days before or two days after the dates indicated in the sampling schedule (i.e., within a five-day period around the schedule date) unless one of the conditions of this subdivision b applies:

(1) If an extreme condition or situation exists that may pose danger to the sample collector or that cannot be avoided and causes the owner to be unable to sample in the scheduled five-day period, then the owner shall sample as close to the scheduled date as is feasible unless the department approves an alternative sampling date. The owner shall submit an explanation for the delayed sampling date to the department concurrent with the shipment of the sample to the laboratory.

(2) If the owner is unable to report a valid analytical result for a scheduled sampling date due to equipment failure, loss of or damage to the sample, failure to comply with the analytical method requirements, including the quality control requirements of 12VAC5-590-440, or the failure of an approved laboratory to analyze the sample, then the owner shall collect a replacement sample. The owner shall collect the replacement sample not later than 21 days after receiving information that an analytical result cannot be reported for the scheduled date unless the owner demonstrates that collecting a replacement sample within this timeframe is not feasible or the department approves an alternative resampling date. The owner shall submit an explanation for the delayed sampling date to the department concurrent with the shipment of the sample to the laboratory.

c. The owner of a waterworks that fails to meet the criteria of subdivision B 5 b of this section for any source water sample required under subsection B of this section shall revise the sampling schedule to add dates for collecting all missed samples. The owner shall submit the revised schedule to the department for approval before the owner begins collecting the missed samples.

6. Sampling locations.

a. The owner of a waterworks required to conduct source water monitoring under subsection B of this section shall collect samples for each water treatment plant that treats a surface water source, a GUDI source, or both. Where multiple water treatment plants draw source water from the same influent, such as the same pipe or intake, the department may approve one set of monitoring results to be used to satisfy the requirements of subsection B of this section for all water treatment plants.

b. The owner shall collect source water samples before chemical treatment, such as coagulants, oxidants, and disinfectants. However, the department may approve the collection of a source water sample after chemical treatment. To grant this approval, the department shall determine that collecting a sample before chemical treatment is not feasible for the owner and that the chemical treatment is unlikely to have a significant adverse effect on the analysis of the sample.

c. The owner of a waterworks that recycles filter backwash water shall collect source water samples before the point of filter backwash water addition.

d. Bank filtration.

(1) The owner that receives Cryptosporidium treatment credit for bank filtration under 12VAC5-590-395 A 2 b (1) shall collect source water samples from the surface water before bank filtration.

(2) The owner that uses bank filtration as pretreatment to a water treatment plant shall collect source water samples from the well (i.e., after bank filtration). The use of bank filtration during monitoring shall be consistent with routine operational practice. The owner collecting samples after a bank filtration process may not receive treatment credit for the bank filtration under subdivision E 4 c of this section.

e. Multiple sources. The owner of a waterworks that uses multiple source waters, including multiple surface water sources and blended surface water and groundwater sources, shall collect samples as specified in subdivision B 6 e (1) or B 6 e (2) of this section. The use of multiple source waters during monitoring shall be consistent with routine operational practice.

(1) If a sampling tap is available where the source waters are combined before treatment, then the owner shall collect samples from the tap.

(2) If a sampling tap is not available where the source waters are combined before treatment, then the owner shall collect samples at each source near the intake on the same day and shall follow either subdivision B 6 e (2) (a) or B 6 e (2) (b) of this section for sample analysis.

(a) The owner may composite samples from each source into one sample before analysis. The volume of sample from each source shall be weighted according to the proportion of the source water in the total water treatment plant flow at the time the sample is collected.

(b) The owner may choose to have samples analyzed from each source separately and calculate a weighted average of the analysis results for each sampling date. The weighted average shall be calculated by multiplying the analysis result for each source water by the fraction the source water contributed to the total water treatment plant flow at the time the sample was collected and then summing these values.

f. Additional requirements. The owner shall submit a description of each sampling location to the department at the same time as the sampling schedule required in subdivision B 3 of this section. This description shall address the position of the sampling location in relation to the waterworks' source waters and treatment processes, including pretreatment, points of chemical treatment, and filter backwash recycle. If the department does not respond to an owner regarding sampling location, then the owner shall sample at each reported location.

7. Analytical methods. All analytical methods shall be conducted in accordance with 12VAC5-590-440.

8. Approved laboratories.

a. Cryptosporidium. The owner shall have Cryptosporidium samples analyzed by a laboratory that has received reciprocal certification approved under the DCLS Laboratory Certification Program for Analysis of Cryptosporidium in Water.

b. E. coli. A laboratory certified by the DCLS for total coliform analysis under 12VAC5-590-440 is approved for E. coli analysis when the laboratory uses the same technique for E. coli that the laboratory uses under 12VAC5-590-440. Laboratories shall use methods for enumeration of E. coli in source water approved in 12VAC5-590-440.

c. Turbidity. Measurements of turbidity shall be made by a party approved by the department.

9. Reporting of the source water results shall be in accordance with 12VAC5-590-531.

10. The owner of a waterworks treating a surface water source, a GUDI source, or both, that operates for only part of the year shall conduct source water monitoring in accordance with this section, but with the following modifications:

a. The owner shall sample the source water only during the months that the waterworks operates unless the department specifies another monitoring period based on waterworks operating practices.

b. The owner of a waterworks that operates less than six months per year and that monitors for Cryptosporidium shall collect at least six Cryptosporidium samples per year during each of two years of monitoring. Samples shall be evenly spaced throughout the period the waterworks operates.

11. New sources.

a. The owner of a waterworks that begins using a surface water source, a GUDI source, or both, is required to begin monitoring under subdivision B 3 of this section and shall monitor the new source on a schedule approved by the department. Source water monitoring shall meet the requirements of this section. The owner shall also meet the bin classification and Cryptosporidium treatment requirements of subdivisions D 1 and D 2 of this section, for the new source on a schedule approved by the department.

b. The requirements of this section apply to a waterworks using a surface water source, a GUDI source, or both, that begins operation after the monitoring start date applicable to the size of the waterworks under subdivision B 3 of this section.

c. The owner shall begin a second round of source water monitoring no later than six years following the initial bin classification under subdivision D 1 of this section.

12. Failure to collect any source water sample required under this section in accordance with the sampling schedule, sampling location, analytical method, approved laboratory, and reporting requirements of subdivisions B 5 through B 9 of this section is a monitoring violation.

13. Grandparenting monitoring data. The owner may use monitoring data collected before the applicable monitoring start date in subdivision B 3 of this section (grandparented data) to meet the initial source water monitoring requirements in subdivision B 1 of this section. Grandparented data may be substituted for an equivalent number of months at the end of the monitoring period. All data submitted under this subdivision B 13 shall meet the requirements in subdivisions B 13 a through B 13 h of this section and be approved by the department:

a. The owner may grandparent Cryptosporidium samples to meet the requirements of this section when the owner does not have corresponding E. coli and turbidity samples. The owner who grandparents Cryptosporidium samples without E. coli and turbidity samples is not required to collect E. coli and turbidity samples when the owner completes the requirements for Cryptosporidium monitoring under this section.

b. The analysis of E. coli samples shall meet the analytical method and approved laboratory requirements of subdivisions B 7 and B 8 of this section.

c. The analysis of Cryptosporidium samples shall meet the requirements of subdivision B 8 of this section.

d. The sampling location shall meet the conditions in subdivision B 6 of this section.

e. Cryptosporidium sample collection intervals may vary for the conditions specified in subdivisions B 5 b (1) and B 5 b (2) of this section if the owner provides documentation of the condition when reporting monitoring results.

(1) The department may approve grandparenting of previously collected data where there are time gaps in the sampling frequency if the owner conducts additional monitoring the department specifies to ensure that the data used to comply with the initial source water monitoring requirements of subsection B of this section are seasonally representative and unbiased.

(2) The owner may grandparent previously collected data where the sampling frequency within each month varied. If the Cryptosporidium sampling frequency varied, then the owner shall follow the monthly averaging procedure in subdivision D 1 a (5) of this section when calculating the bin classification for a filtered waterworks.

f. The owner of a waterworks that requests to grandparent previously collected monitoring results shall report the following information by the applicable dates listed in the following subdivisions. The owner shall report this information to the department.

(1) The owner shall report the intent to submit previously collected monitoring results for grandparenting. This report shall specify the number of previously collected results the owner shall submit, the dates of the first and last sample, and whether an owner shall conduct additional source water monitoring to meet the requirements in subsection B of this section. The owner shall report this information no later than the date the sampling schedule listed in subdivision B 3 of this section is required.

(2) The owner shall report previously collected monitoring results for grandparenting no later than two months after the applicable date listed in subdivision B 3 of this section.

(a) For each sample result, the owner shall report the applicable data elements in 12VAC5-590-531 A 5.

(b) The owner shall certify that the reported monitoring results include all results the waterworks generated during the time period beginning with the first reported result and ending with the final reported result. This applies to samples that were collected from the sampling location specified for source water monitoring under subdivision B 1 of this section, not spiked, and analyzed using the laboratory's routine process for the analytical methods listed in this section.

(c) The owner shall certify that the samples were representative of a waterworks' source waters and the source waters have not changed. The owner shall report a description of each sampling location, which shall address the position of the sampling location in relation to the waterworks' source waters and treatment processes, including points of chemical addition and filter backwash recycle.

(d) For Cryptosporidium samples, the laboratory that analyzed the samples shall provide a letter certifying that the quality control criteria specified in the methods listed in subdivision B 8 of this section were met for each sample batch associated with the reported results. Alternatively, the laboratory may provide bench sheets and sample examination report forms for each field, matrix spike, initial precision and recovery (IPR), ongoing precision and recovery (OPR), and method blank sample associated with the reported results.

g. If the department determines that a previously collected data set submitted for grandparenting was generated during source water conditions that were not normal for the waterworks, such as a drought, the department may disapprove the data. Alternatively, the department may approve the previously collected data if the owner reports additional source water monitoring data, as determined by the department, to ensure that the data set used under subdivision D 1 of this section represents average source water conditions for the waterworks.

h. If the owner submits previously collected data that fully meets the number of samples required for initial source water monitoring under subdivision B 1 of this section and some of the data are rejected due to not meeting the requirements of this section, then the owner shall conduct additional monitoring to replace rejected data on a schedule approved by the department. The owner is not required to begin this additional monitoring until two months after notification that data have been rejected and additional monitoring is necessary.

C. The owner of a waterworks that plans to make a significant change to the disinfection practice shall develop disinfection profiles and calculate disinfection benchmarks as described in 12VAC5-590-500.

1. The owner shall notify the department before changing the disinfection practice and shall include in this notice the following information:

a. A completed disinfection profile and disinfection benchmark for Giardia lamblia and viruses;

b. A description of the proposed change in disinfection practice; and

c. An analysis of how the proposed change will affect the current level of disinfection.

2. Significant changes to the disinfection practice are defined as follows:

a. Changes to the point of disinfection;

b. Changes to any disinfectant used in the water treatment plant;

c. Changes to the disinfection process; or

d. Any other modification identified by the department as a significant change to disinfection practice.

D. The owner shall determine the Cryptosporidium treatment bin classification as described in subdivision D 1 of this section and provide additional treatment for Cryptosporidium, if required, as described in subdivision D 2 of this section. The owner shall implement Cryptosporidium treatment according to the schedule in subdivision D 3 of this section.

1. Bin classification for waterworks.

a. Following completion of the initial round of source water monitoring required under subdivision B 1 of this section, the owner shall calculate an initial Cryptosporidium bin concentration for each water treatment plant for which monitoring was required. Calculation of the bin concentration shall use the Cryptosporidium results reported under subdivision B 1 of this section and shall follow these procedures:

(1) For the owner who collects a total of at least 48 samples, the bin concentration is equal to the arithmetic mean of all sample concentrations.

(2) For the owner who collects a total of at least 24 samples, but not more than 47 samples, the bin concentration is equal to the highest arithmetic mean of all sample concentrations in any 12 consecutive months during which Cryptosporidium samples were collected.

(3) For the owner of a waterworks that serves fewer than 10,000 people and monitors for Cryptosporidium for only one year (i.e., collect 24 samples in 12 months), the bin concentration is equal to the arithmetic mean of all sample concentrations.

(4) For water treatment plants that operate only part of the year and that monitor fewer than 12 months per year under subdivision B 1 of this section, the bin concentration is equal to the highest arithmetic mean of all sample concentrations during any year of Cryptosporidium monitoring.

(5) If the monthly Cryptosporidium sampling frequency varies, then the owner shall first calculate a monthly average for each month of monitoring. The owner shall then use these monthly average concentrations, rather than individual sample concentrations, in the applicable calculation for bin classification in subdivisions D 1 a (1) through D 1 a (4) of this section.

b. The owner shall determine the initial bin classification from Table 401.2 using the Cryptosporidium bin concentration calculated under subdivision D 1 a of this section:

| TABLE 401.2 Bin Classification for Filtered Waterworks | | | | --- | --- | --- | | FOR OWNERS OF WATERWORKS THAT ARE... | WITH A CRYPTOSPORIDIUM BIN CONCENTRATION OF^a... | THE BIN CLASSIFICATION IS... | | Required to monitor for Cryptosporidium under subdivision B 1 of this section | Cryptosporidium less than 0.075 oocysts/L | Bin 1 | | Cryptosporidium equal to or greater than 0.075 oocysts/L but less than 1.0 oocysts/L | Bin 2 | | | Cryptosporidium equal to or greater than 1.0 oocysts/L but less than 3.0 oocysts/L | Bin 3 | | | Cryptosporidium equal to or greater than 3.0 oocysts/L | Bin 4 | | | Serving fewer than 10,000 people and NOT required to monitor for Cryptosporidium under subdivision B 1 c of this section | Not Applicable | Bin 1 | | ^aBased on calculations in subdivision D 1 a or D 1 c of this section, as applicable. | | |

c. Following completion of the second round of source water monitoring required under subdivision B 2 of this section, the owner shall recalculate the Cryptosporidium bin concentration using the Cryptosporidium results reported under subdivision B 2 of this section and following the procedures in subdivisions D 1 a (1) through D 1 a (4) of this section. The owner shall then redetermine the bin classification using this bin concentration and Table 401.3.

d. Reporting of bin classifications.

(1) The owner shall report the initial bin classification under subdivision D 1 b of this section to the department for approval no later than six months after the waterworks is required to complete the initial source water monitoring based on the schedule in subdivision B 3 of this section.

(2) The owner shall report the bin classification under subdivision D 1 c of this section to the department for approval no later than six months after the owner is required to complete the second round of source water monitoring based on the schedule in subdivision D 1 a (3) of this section.

(3) The bin classification report to the department shall include a summary of source water monitoring data and the calculation procedure used to determine bin classification.

e. Failure to comply with the conditions of subdivision D 1 d of this section is a violation of the treatment technique requirement.

2. Waterworks additional Cryptosporidium treatment requirements.

a. A waterworks shall provide the level of additional treatment for Cryptosporidium specified in this subdivision based on the bin classification as determined under subdivision D 1 of this section and according to the schedule in subdivision D 3 b of this section.

| TABLE 401.3. Cryptosporidium Treatment Requirements | | | | | | --- | --- | --- | --- | --- | | IF THE WATERWORKS BIN CLASSIFICATION IS... | AND THE WATERWORKS USES THE FOLLOWING FILTRATION TREATMENT IN FULL COMPLIANCE WITH 12VAC5-590-395 A 1 AND 12VAC5-590-395 A 2, THEN THE ADDITIONAL CRYPTOSPORIDIUM TREATMENT REQUIREMENTS ARE... | | | | | | Conventional filtration treatment (including softening) | Direct filtration | Slow sand or diatomaceous earth filtration | Alternative filtration technologies | | Bin 1 | No additional treatment | No additional treatment | No additional treatment | No additional treatment | | Bin 2 | 1-log treatment | 1.5-log treatment | 1-log treatment | a | | Bin 3 | 2-log treatment | 2.5-log treatment | 2-log treatment | b | | Bin 4 | 2.5-log treatment | 3-log treatment | 2.5-log treatment | c | | ^aAs determined by the department such that the total Cryptosporidium removal and inactivation is at least 4.0-log. ^bAs determined by the department such that the total Cryptosporidium removal and inactivation is at least 5.0-log. ^cAs determined by the department such that the total Cryptosporidium removal and inactivation is at least 5.5-log. | | | | |

b. Additional treatment.

(1) The owner shall use one or more of the treatment and management options listed in subsection E of this section, termed the microbial toolbox, to comply with the additional Cryptosporidium treatment required in subdivision D 2 a of this section.

(2) A waterworks classified in Bin 3 and Bin 4 shall achieve at least 1-log of the additional Cryptosporidium treatment required under subdivision D 2 a of this section using either one or a combination of the following: (i) bag filters, (ii) bank filtration, (iii) cartridge filters, (iv) chlorine dioxide, (v) membranes, (vi) ozone, or (vii) UV as described in subdivisions E 3 through E 7 of this section.

c. Failure by a waterworks in any month to achieve treatment credit by meeting criteria in subdivisions E 3 through E 7 of this section for microbial toolbox options that is at least equal to the level of treatment required in subdivision D 2 a of this section is a violation of the treatment technique requirement.

d. If the department determines during a sanitary survey or an equivalent source water assessment that after an owner completed the monitoring conducted under subdivision B 1 or B 2 of this section, significant changes occurred in the waterworks watershed that could lead to increased contamination of the source water by Cryptosporidium, then the owner shall take actions specified by the department to address the contamination. These actions may include additional source water monitoring or implementing microbial toolbox options listed in subdivision E 2 of this section.

3. Schedule for compliance with Cryptosporidium treatment requirements.

a. Following the initial bin classification in accordance with subdivision D 1 b of this section, the owner shall provide the level of treatment for Cryptosporidium required under subdivision D 2 of this section according to the schedule in subdivision D 3 b of this section.

b. If the bin classification for a filtered waterworks changes following the second round of source water monitoring, as determined under subdivision D 1 c of this section, then the owner shall provide the level of treatment for Cryptosporidium required under subdivision D 2 of this section on a schedule approved by the department.

E. The owner of a waterworks required to provide additional treatment for Cryptosporidium shall implement microbial toolbox options that are designed and operated as described in subdivisions E 1 through E 7 of this section.

1. The owner receives the treatment credits listed in Table 401.4 by meeting the conditions for microbial toolbox options described in subdivisions E 3 through E 7 of this section. The owner shall apply these treatment credits to meet the treatment requirements in subdivision D 2 of this section.

2. Microbial Toolbox Summary Table: Options, Treatment Credits and Criteria.

| TABLE 401.4 Microbial Toolbox Summary: Options, Treatment Credits and Criteria | | | --- | --- | | TOOLBOX OPTION | CRYPTOSPORIDIUM TREATMENT CREDIT WITH DESIGN AND IMPLEMENTATION CRITERIA | | Source Protection and Management Toolbox Options | | | Alternative source and intake management | No prescribed credit. The owner may conduct simultaneous monitoring for treatment bin classification at alternative intake locations or under alternative intake management strategies. Specific criteria are in subdivision E 3 b of this section. | | Prefiltration Toolbox Options | | | Presedimentation basin with coagulation | 0.5-log credit during any month that presedimentation basins achieve a monthly mean reduction of 0.5-log or greater in turbidity or alternative performance criteria approved by the department. To be eligible, basins shall be operated continuously with coagulant addition and all water treatment plant flow shall pass through basins. Specific criteria are in subdivision E 4 a of this section. | | Two-stage lime softening | 0.5-log credit for two-stage softening where chemical addition and hardness precipitation occur in both stages. All water treatment plant flow shall pass through both stages. Single-stage softening is credited as equivalent to conventional treatment. Specific criteria are in subdivision E 4 b of this section. | | Bank filtration | 0.5-log credit for 25-foot setback; 1.0-log credit for 50-foot setback; aquifer shall be unconsolidated sand containing at least 10% fines; average turbidity in wells shall be less than 1 NTU. A waterworks using wells followed by filtration when conducting source water monitoring shall sample the well to determine bin classification and is not eligible for additional credit. Specific criteria are in subdivision E 4 c of this section. | | Treatment Performance Toolbox Options | | | Combined filter performance | 0.5-log credit for CFE turbidity less than or equal to 0.15 NTU in at least 95% of measurements each month. Specific criteria are in subdivision E 5 a of this section. | | Individual filter performance | 0.5-log credit (in addition to 0.5-log combined filter performance credit) if individual filter effluent turbidity is less than or equal to 0.15 NTU in at least 95% of samples each month in each filter and is never greater than 0.3 NTU in two consecutive measurements in any filter. Specific criteria are in subdivision E 5 b of this section. | | Additional Filtration Toolbox Options | | | Bag or cartridge filters (individual filters) | Up to 2-log credit based on the removal efficiency demonstrated during challenge testing with a 1.0-log factor of safety. Specific criteria are in subdivision E 6 a of this section. | | Bag or cartridge filters (in series) | Up to 2.5-log credit based on the removal efficiency demonstrated during challenge testing with a 0.5-log factor of safety. Specific criteria are in subdivision E 6 a of this section. | | Membrane filtration | Log credit equivalent to removal efficiency demonstrated in challenge test for device if supported by direct integrity testing. Specific criteria are in subdivision E 6 b of this section. | | Second stage filtration | 0.5-log credit for second separate granular media filtration stage if treatment train includes coagulation before first filter. Specific criteria are in subdivision E 6 c of this section. | | Slow sand filters | 2.5-log credit as a secondary filtration step; 3.0-log credit as a primary filtration process. No prior chlorination for either option. Specific criteria are in subdivision E 6 d of this section. | | Inactivation Toolbox Options | | | Chlorine dioxide | Log credit based on measured CT in relation to Table 401.5. Specific criteria in subdivision E 7 b of this section. | | Ozone | Log credit based on measured CT in relation to Table 401.6. Specific criteria in subdivision E 7 b of this section. | | UV | Log credit based on validated UV dose in relation to Table 401.7; reactor validation testing required to establish UV dose and associated operating conditions. Specific criteria in subdivision E 7 c of this section. |

3. Source toolbox components.

a. Reserved.

b. Alternative source.

(1) The owner may conduct source water monitoring that reflects a different intake location (either in the same source or for an alternate source) or a different procedure for the timing or level of withdrawal from the source (alternative source water monitoring). If the department approves, then the owner may determine the bin classification under subdivision D 1 of this section based on the alternative source water monitoring results.

(2) If the owner conducts alternative source water monitoring under subdivision E 3 b (1) of this section, then the owner shall also monitor the current water treatment plant intake concurrently as described in subsection B of this section. "Plant intake" means the works or structures at the head of a conduit through which source water is diverted (e.g., river or lake) into the water treatment plant.

(3) Alternative source water monitoring under subdivision E 3 b (1) of this section shall meet the requirements for source water monitoring to determine bin classification, as described in subdivisions B 1 through B 13 of this section. The owner shall report the alternative source water monitoring results to the department, along with supporting information documenting the operating conditions under which the samples were collected.

(4) If the owner determines the bin classification under subdivision D 1 of this section using alternative source water monitoring results that reflect a different intake location or a different procedure for managing the timing or level of withdrawal from the source, then the owner shall relocate the intake or permanently adopt the withdrawal procedure, as applicable, no later than the applicable treatment compliance date in subdivision D 3 of this section.

4. Prefiltration treatment toolbox components.

a. Presedimentation. The owner receives 0.5-log Cryptosporidium treatment credit for a presedimentation basin during any month the process meets the following criteria:

(1) The presedimentation basin shall be in continuous operation and shall treat the entire water treatment plant flow at a waterworks using a surface water source, a GUDI source, or both.

(2) A coagulant shall be continuously added to the presedimentation basin.

(3) The presedimentation basin shall achieve the performance criteria in either of the following:

(a) Demonstrates at least 0.5-log mean reduction of influent turbidity. This reduction shall be determined using daily turbidity measurements in the presedimentation process influent and effluent and shall be calculated as follows: log10 (monthly mean of daily influent turbidity) - log10 (monthly mean of daily effluent turbidity).

(b) Complies with the performance criteria approved by the department that demonstrate at least 0.5-log mean removal of micron-sized particulate material through the presedimentation process.

b. Two-stage lime softening. The owner receives an additional 0.5-log Cryptosporidium treatment credit for a two-stage lime softening plant if chemical addition and hardness precipitation occur in two separate and sequential softening stages before filtration. Both softening stages shall treat the entire plant flow taken from a surface water source, a GUDI source, or both.

c. Bank filtration. The owner receives Cryptosporidium treatment credit for bank filtration that serves as pretreatment to a water filtration plant by meeting the criteria in this subdivision. The owner using bank filtration upon beginning source water monitoring under subdivision B 1 of this section shall collect samples as described in subdivision B 6 d of this section and is not eligible for this credit.

(1) Wells with a groundwater flow path of at least 25 feet receive 0.5-log treatment credit; and wells with a groundwater flow path of at least 50 feet receive 1.0-log treatment credit. The groundwater flow path shall be determined as specified in subdivision E 4 c (4) of this section.

(2) Only wells in granular aquifers are eligible for treatment credit. Granular aquifers are those comprised of sand, clay, silt, rock fragments, pebbles or larger particles, and minor cement. The owner shall characterize the aquifer at the well site to determine aquifer properties. The owner shall extract a core from the aquifer and demonstrate that in at least 90% of the core length, grains less than 1.0 mm in diameter constitute at least 10% of the core material.

(3) Only horizontal and vertical wells are eligible for treatment credit.

(4) For vertical wells, the groundwater flow path is the measured distance from the edge of the surface water body under high flow conditions (determined by the 100-year flood elevation boundary or by the floodway, as defined in Federal Emergency Management Agency flood hazard maps) to the well screen. For horizontal wells, the groundwater flow path is the measured distance from the bed of the river under normal flow conditions to the closest horizontal well lateral screen.

(5) The owner shall monitor each wellhead for turbidity at least once every four hours while the bank filtration process is in operation. If monthly average turbidity levels, based on daily maximum values in the well, exceed 1 NTU, the owner shall report this result to the department and conduct an assessment within 30 days to determine the cause of the high turbidity levels in the well. If the department determines that microbial removal has been compromised, the department may revoke treatment credit until the owner implements corrective actions approved by the department to remediate the problem.

(6) Springs and infiltration galleries are not eligible for treatment credit under this section.

(7) Bank filtration demonstration of performance. The department may approve Cryptosporidium treatment credit for bank filtration based on a demonstration-of-performance study that meets the criteria in this subdivision. This treatment credit may be greater than 1.0-log and may be awarded to bank filtration that does not meet the criteria in subdivisions E 4 c (1) through E 4 c (5) of this section.

(a) The study shall follow a protocol approved by the department and shall involve the collection of data on the removal of Cryptosporidium or a surrogate for Cryptosporidium and related hydrogeologic and water quality parameters during the full range of operating conditions.

(b) The study shall include sampling both from any production well and from monitoring wells that are screened and located along the shortest flow path between the surface water source and the production well.

5. Treatment performance toolbox components.

a. Combined filter performance. The owner using conventional filtration treatment or direct filtration treatment receives an additional 0.5-log Cryptosporidium treatment credit during any month the waterworks meets the criteria in this subdivision. Combined filter effluent (CFE) turbidity shall be less than or equal to 0.15 NTU in at least 95% of the measurements. Turbidity shall be measured as described in 12VAC5-590-376 B.

b. Individual filter performance. The owner using conventional filtration treatment or direct filtration treatment receives 0.5-log Cryptosporidium treatment credit, which can be in addition to the 0.5-log credit under subdivision E 5 a of this section, during any month the waterworks meets the criteria in this subdivision. Compliance with these criteria shall be based on individual filter turbidity monitoring as described in 12VAC5-590-376 B.

(1) The filtered water turbidity for each individual filter shall be less than or equal to 0.15 NTU in at least 95% of the measurements recorded each month.

(2) No individual filter may have a measured turbidity greater than 0.3 NTU in two consecutive measurements collected 15 minutes apart.

(3) The owner that has received treatment credit for individual filter performance and fails to meet the requirements of subdivision E 5 b (1) or E 5 b (2) of this section during any month does not receive a treatment technique violation under subdivision D 2 c of this section if the department determines the following:

(a) The failure was due to unusual and short-term circumstances that could not reasonably be prevented through optimizing water treatment plant design, operation, and maintenance.

(b) The waterworks has experienced no more than two failures in any calendar year.

6. Additional filtration toolbox components.

a. Bag and cartridge filters. The owner receives Cryptosporidium treatment credit of up to 2.0-log for individual bag or cartridge filters and up to 2.5-log for bag or cartridge filters operated in series by meeting the criteria in subdivisions E 6 a (1) through E 6 a (10) of this section. To be eligible for this credit, the owner shall report the results of challenge testing that meets the requirements of subdivisions E 6 a (2) through E 6 a (9) of this section to the department. The filters shall treat the entire water treatment plant flow taken from a surface water source, a GUDI source, or both.

(1) The Cryptosporidium treatment credit awarded to bag or cartridge filters shall be based on the removal efficiency demonstrated during challenge testing that is conducted according to the criteria in subdivisions E 6 a (2) through E 6 a (9) of this section. A factor of safety equal to 1-log for individual bag or cartridge filters and 0.5-log for bag or cartridge filters in series shall be applied to challenge testing results to determine removal credit. The owner may use the results from challenge testing conducted before January 5, 2006, if the prior testing was consistent with the criteria specified in subdivisions E 6 a (2) through E 6 a (9) of this section.

(2) Challenge testing shall be performed on full-scale bag or cartridge filters, and the associated filter housing or pressure vessel, that are identical in material and construction to the filters and housings the waterworks will use for removal of Cryptosporidium. Bag or cartridge filters shall be challenge tested in the same configuration that the waterworks will use, either as individual filters or as a series configuration of filters.

(3) Challenge testing shall be conducted using Cryptosporidium or a surrogate that is removed no more efficiently than Cryptosporidium. The microorganism or surrogate used during challenge testing is referred to as the challenge particulate. The concentration of the challenge particulate shall be determined using a method capable of discreetly quantifying the specific microorganism or surrogate used in the test; gross measurements such as turbidity shall not be used.

(4) The maximum feed water concentration that can be used during a challenge test shall be based on the detection limit of the challenge particulate in the filtrate (i.e., filtrate detection limit) and shall be calculated using the following equation:

Maximum Feed Concentration = 1 x 10⁴ x (Filtrate Detection Limit)

(5) Challenge testing shall be conducted at the maximum design flow rate for the filter as specified by the manufacturer.

(6) Each filter evaluated shall be tested for a duration sufficient to reach 100% of the terminal pressure drop that establishes the maximum pressure drop under which the filter may be used to comply with the requirements of this subdivision E 6.

(7) Removal efficiency of a filter shall be determined from the results of the challenge test and expressed in terms of log removal values using the following equation:

LRV = LOG₁₀(C_f) - LOG₁₀(C_p),

where LRV = log removal value demonstrated during challenge testing;

C_f = the feed concentration measured during the challenge test; and

C_p = the filtrate concentration measured during the challenge test.

In applying this equation, the same units shall be used for the feed and filtrate concentrations. If the challenge particulate is not detected in the filtrate, then the term C_p shall be set equal to the detection limit.

(8) Each filter tested shall be challenged with the challenge particulate during three periods over the filtration cycle: within two hours of start-up of a new filter; when the pressure drop is between 45% and 55% of the terminal pressure drop; and at the end of the cycle after the pressure drop has reached 100% of the terminal pressure drop. An LRV shall be calculated for each of these challenge periods for each filter tested. The LRV for the filter (LRV filter) shall be assigned the value of the minimum LRV observed during the three challenge periods for that filter.

(9) If fewer than 20 filters are tested, then the overall removal efficiency for the filter product line shall be set equal to the lowest LRV filter among the filters tested. If 20 or more filters are tested, then the overall removal efficiency for the filter product line shall be set equal to the 10th percentile of the set of LRV filter values for the various filters tested. The percentile is defined by (i/(n+1)), where i is the rank of n individual data points ordered lowest to highest. If necessary, the 10th percentile may be calculated using linear interpolation.

(10) If a previously tested filter is modified in a manner that could change the removal efficiency of the filter product line, then challenge testing to demonstrate the removal efficiency of the modified filter shall be conducted and submitted to the department.

b. Membrane filtration.

(1) The owner receives Cryptosporidium treatment credit for membrane filtration that meets the criteria of this subdivision E 6 b. Membrane cartridge filters that meet the definition of membrane filtration in 12VAC5-590-10 are eligible for this credit. The level of treatment credit the owner receives is equal to the lower of the values determined as follows:

(a) The removal efficiency demonstrated during challenge testing conducted under the conditions in subdivision E 6 b (2) of this section.

(b) The maximum removal efficiency that can be verified through direct integrity testing used with the membrane filtration process under the conditions in subdivision E 6 b (3) of this section.

(2) Challenge Testing. The membrane used by the waterworks shall undergo challenge testing to evaluate removal efficiency and the owner shall report the results of the challenge testing to the department. Challenge testing shall be conducted according to the criteria in subdivisions E 6 b (2) (a) through E 6 b (2) (g) of this section. The owner may use data from challenge testing conducted before January 5, 2006, if the prior testing was consistent with the following criteria:

(a) Challenge testing shall be conducted on either a full-scale membrane module, identical in material and construction to the membrane modules used in the waterworks treatment facility, or a smaller-scale membrane module, identical in material and similar in construction to the full-scale module. A module is defined as the smallest component of a membrane unit in which a specific membrane surface area is housed in a device with a filtrate outlet structure.

(b) Challenge testing shall be conducted using Cryptosporidium or a surrogate that is removed no more efficiently than Cryptosporidium. The organism or surrogate used during challenge testing is referred to as the challenge particulate. The concentration of the challenge particulate, in both the feed and filtrate water, shall be determined using a method capable of discretely quantifying the specific challenge particulate used in the test; gross measurements such as turbidity shall not be used.

(c) The maximum feed water concentration that can be used during a challenge test is based on the detection limit of the challenge particulate in the filtrate and shall be determined according to the following equation:

Maximum Feed Concentration = 3.16 x 10⁶ x (Filtrate Detection Limit)

(d) Challenge testing shall be conducted under representative hydraulic conditions at the maximum design flux and maximum design process recovery specified by the manufacturer for the membrane module. Flux is defined as the throughput of a pressure-driven membrane process expressed as flow per unit of membrane area. Recovery is defined as the volumetric percent of feed water that is converted to filtrate over the course of an operating cycle uninterrupted by events such as chemical cleaning or a solids removal process (i.e., backwashing).

(e) Removal efficiency of a membrane module shall be calculated from the challenge test results and expressed as a log removal value according to the following equation:

LRV = LOG₁₀(C_f) - LOG₁₀(C_p),

where LRV = log removal value demonstrated during the challenge test;

C_f = the feed concentration measured during the challenge test; and

C_p = the filtrate concentration measured during the challenge test.

Equivalent units shall be used for the feed and filtrate concentrations. If the challenge particulate is not detected in the filtrate, then the term C_p is set equal to the detection limit for the purpose of calculating the LRV. An LRV shall be calculated for each membrane module evaluated during the challenge test.

(f) The removal efficiency of a membrane filtration process demonstrated during challenge testing shall be expressed as a log removal value (LRV_C-Test). If fewer than 20 modules are tested, then LRV_C-Test is equal to the lowest of the representative LRVs among the modules tested. If 20 or more modules are tested, then LRV_C-Test is equal to the 10th percentile of the representative LRVs among the modules tested. The percentile is defined by (i/(n+1)), where i is the rank of n individual data points ordered lowest to highest. If necessary, the 10th percentile may be calculated using linear interpolation.

(g) The challenge test shall establish a QCRV for a nondestructive performance test that demonstrates the Cryptosporidium removal capability of the membrane filtration module. This performance test shall be applied to each production membrane module used by the waterworks that was not directly challenge tested to verify Cryptosporidium removal capability. Production modules that do not meet the established QCRV are not eligible for the treatment credit demonstrated during the challenge test.

(h) If a previously tested membrane is modified in a manner that could change the removal efficiency of the membrane or the applicability of the nondestructive performance test and associated QCRV, then additional challenge testing to demonstrate the removal efficiency of, and determine a new QCRV for, the modified membrane shall be conducted and submitted to the department.

(3) Direct integrity testing. The owner shall conduct direct integrity testing in a manner that demonstrates a removal efficiency equal to or greater than the removal credit awarded to the membrane filtration process and meets the requirements described in subdivisions E 6 b (3) (a) through E 6 b (3) (f) of this section. A direct integrity test is defined as a physical test applied to a membrane unit to identify and isolate integrity breaches (i.e., one or more leaks that could result in contamination of the filtrate).

(a) The direct integrity test shall be independently applied to each membrane unit in service. A membrane unit is defined as a group of membrane modules that share common valving that allows the unit to be isolated from the rest of the waterworks for the purpose of integrity testing or other maintenance.

(b) The direct integrity method shall have a resolution of three micrometers or less, where resolution is defined as the size of the smallest integrity breach that contributes to a response from the direct integrity test.

(c) The direct integrity test shall have a sensitivity sufficient to verify the log treatment credit awarded to the membrane filtration process by the department, where sensitivity is defined as the maximum log removal value that can be reliably verified by a direct integrity test. Sensitivity shall be determined using the approach in either of the following as applicable to the type of direct integrity test the waterworks uses:

(i) For direct integrity tests that use an applied pressure or vacuum, the direct integrity test sensitivity shall be calculated according to the following equation:

LRV_DIT = LOG₁₀(Q_p /(VCF x Q_breach)),

where LRV_DIT = the sensitivity of the direct integrity test;

Q_p = total design filtrate flow from the membrane unit;

Q_breach = flow of water from an integrity breach associated with the smallest integrity test response that can be reliably measured; and

VCF = volumetric concentration factor.

The volumetric concentration factor is the ratio of the suspended solids concentration on the high-pressure side of the membrane relative to that in the feed water.

(ii) For direct integrity tests that use a particulate or molecular marker, the direct integrity test sensitivity shall be calculated according to the following equation:

LRV_DIT = LOG₁₀(C_f) - LOG₁₀(C_p),

where LRV_DIT = the sensitivity of the direct integrity test;

C_f = the typical feed concentration of the marker used in the test; and

C_p = the filtrate concentration of the marker from an integral membrane unit.

(d) The owner shall establish a control limit within the sensitivity limits of the direct integrity test that is indicative of an integral membrane unit capable of meeting the removal credit awarded by the department.

(e) If the result of a direct integrity test exceeds the control limit established under subdivision E 6 b (3) (d) of this section, then the owner shall remove the membrane unit from service. The owner shall conduct a direct integrity test to verify any repairs, and may return the membrane unit to service only if the direct integrity test is within the established control limit.

(f) The owner shall conduct direct integrity testing on each membrane unit at a frequency of not less than once each day that the membrane unit is in operation. The department may approve less frequent testing based on demonstrated process reliability, the use of multiple barriers effective for Cryptosporidium, or reliable process safeguards.

(4) Indirect integrity monitoring. The owner shall conduct continuous indirect integrity monitoring on each membrane unit according to the criteria in subdivisions E 6 b (4) (a) through E 6 b (4) (e). Indirect integrity monitoring is defined as monitoring some aspect of filtrate water quality that is indicative of the removal of particulate matter. The owner that implements continuous direct integrity testing of membrane units in accordance with the criteria in subdivisions E 6 b (3) (a) through E 6 b (3) (f) of this section is not subject to the requirements for continuous indirect integrity monitoring. The owner shall submit a monthly report to the department summarizing all continuous indirect integrity monitoring results triggering direct integrity testing and the corrective action that was taken in each case.

(a) Unless the department approves an alternative parameter, continuous indirect integrity monitoring shall include continuous filtrate turbidity monitoring.

(b) Continuous monitoring shall be conducted at a frequency of no less than once every 15 minutes.

(c) Continuous monitoring shall be separately conducted on each membrane unit.

(d) If indirect integrity monitoring includes turbidity and if the filtrate turbidity readings are above 0.15 NTU for a period greater than 15 minutes (i.e., two consecutive 15-minute readings above 0.15 NTU), direct integrity testing shall immediately be performed on the associated membrane unit as specified in subdivisions E 6 b (3) (a) through E 6 b (3) (f) of this section.

(e) If indirect integrity monitoring includes an alternative parameter approved by the department and if the alternative parameter exceeds a control limit approved by the department for a period greater than 15 minutes, then direct integrity testing shall immediately be performed on the associated membrane units as specified in subdivisions E 6 b (3) (a) through E 6 b (3) (f) of this section.

c. Second stage filtration. The owner receives 0.5-log Cryptosporidium treatment credit for a separate second stage of filtration that consists of sand, dual media, GAC, or other fine grain media following granular media filtration if approved by the department. To be eligible for this credit, the first stage of filtration shall be preceded by a coagulation step and both filtration stages shall treat the entire water treatment treatment plant flow taken from a surface water source, a GUDI source, or both. A cap, such as GAC, on a single stage of filtration is not eligible for this credit. The department shall approve the treatment credit based on an assessment of the design characteristics of the filtration process.

d. Slow sand filtration as secondary filter. The owner is eligible to receive 2.5-log Cryptosporidium treatment credit for a slow sand filtration process that follows a separate stage of filtration if both filtration stages treat the entire water treatment plant flow taken from a surface water source, a GUDI source, or both and no residual disinfectant is present in the influent water to the slow sand filtration process. The department shall approve the treatment credit based on an assessment of the design characteristics of the filtration process. This subdivision does not apply to treatment credit awarded to slow sand filtration used as a primary filtration process.

7. Inactivation toolbox components.

a. Calculation of CT values.

(1) CT is the product of the disinfectant contact time (T, in minutes) and disinfectant concentration (C, in milligrams per liter). The owner of a waterworks with treatment credit for chlorine dioxide or ozone under subdivision E 7 b of this section shall calculate CT at least once each day, with both C and T measured during peak hourly flow in accordance with the procedure listed in 12VAC5-590-500.

(2) A waterworks with several disinfection segments in sequence may calculate CT for each segment, where a disinfection segment is defined as a treatment unit process with a measurable residual disinfectant level and a liquid volume. Under this approach, the owner shall add the Cryptosporidium CT values in each segment to determine the total CT for the treatment plant.

b. CT values for chlorine dioxide and ozone.

(1) The owner receives the Cryptosporidium treatment credit listed in Table 401.5 by meeting the corresponding chlorine dioxide CT value for the applicable water temperature, as described in subdivision E 7 a of this section.

| TABLE 401.5 CT Values (mg-min/L) for Cryptosporidium Inactivation by Chlorine Dioxide^a | | | | | | | | --- | --- | --- | --- | --- | --- | --- | | | WATER TEMPERATURE, ^oC | | | | | | | LOG CREDIT | ≤0.5 | 1 | 2 | 3 | 5 | 7 | | 0.25 | 159 | 153 | 140 | 128 | 107 | 90 | | 0.5 | 319 | 305 | 279 | 256 | 214 | 180 | | 1.0 | 637 | 610 | 558 | 511 | 429 | 360 | | 1.5 | 956 | 915 | 838 | 767 | 643 | 539 | | 2.0 | 1275 | 1220 | 1117 | 1023 | 858 | 719 | | 2.5 | 1594 | 1525 | 1396 | 1278 | 1072 | 899 | | 3.0 | 1912 | 1830 | 1675 | 1534 | 1286 | 1079 | | | | | | | | | | | WATER TEMPERATURE, ^oC | | | | | | | LOG CREDIT | 10 | 15 | 20 | 25 | 30 | | | 0.25 | 69 | 45 | 29 | 19 | 12 | | | 0.5 | 138 | 89 | 58 | 38 | 24 | | | 1.0 | 277 | 179 | 116 | 75 | 49 | | | 1.5 | 415 | 268 | 174 | 113 | 73 | | | 2.0 | 553 | 357 | 232 | 150 | 98 | | | 2.5 | 691 | 447 | 289 | 188 | 122 | | | 3.0 | 830 | 536 | 347 | 226 | 147 | | | ^aThe owner may use this equation to determine log credit between the indicated values: Log credit = (0.001506×(1.09116)^Temp)× CT. | | | | | | |

(2) The owner receives the Cryptosporidium treatment credit listed in Table 401.6 by meeting the corresponding ozone CT values for the applicable water temperature, as described in subdivision E 7 a of this section.

| TABLE 401.6 CT Values (mg-min/L) for Cryptosporidium Inactivation by Ozone^a | | | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | LOG CREDIT | WATER TEMPERATURE, °C | | | | | | | | | | | | ≤0.5 | 1 | 2 | 3 | 5 | 7 | 10 | 15 | 20 | 25 | 30 | | | 0.25 | 6.0 | 5.8 | 5.2 | 4.8 | 4.0 | 3.3 | 2.5 | 1.6 | 1.0 | 0.6 | 0.39 | | 0.5 | 12 | 12 | 10 | 9.5 | 7.9 | 6.5 | 4.9 | 3.1 | 2.0 | 1.2 | 0.78 | | 1.0 | 24 | 23 | 21 | 19 | 16 | 13 | 9.9 | 6.2 | 3.9 | 2.5 | 1.6 | | 1.5 | 36 | 35 | 31 | 29 | 24 | 20 | 15 | 9.3 | 5.9 | 3.7 | 2.4 | | 2.0 | 48 | 46 | 42 | 38 | 32 | 26 | 20 | 12 | 7.8 | 4.9 | 3.1 | | 2.5 | 60 | 58 | 52 | 48 | 40 | 33 | 25 | 16 | 9.8 | 6.2 | 3.9 | | 3.0 | 72 | 69 | 63 | 57 | 47 | 39 | 30 | 19 | 12 | 7.4 | 4.7 | | ^aThe owner may use this equation to determine log credit between the indicated values: Log credit = (0.0397×(1.09757)^Temp)× CT. | | | | | | | | | | | |

c. UV light. The owner receives Cryptosporidium, Giardia lamblia, and virus treatment credits for UV light reactors by achieving the corresponding UV dose values shown in subdivision E 7 c (1) of this section. The owner shall validate and monitor UV reactors as described in subdivisions E 7 c (2) and E 7 c (3) of this section to demonstrate that they are achieving a particular UV dose value for treatment credit.

(1) UV dose table. The treatment credits listed in Table 401.7 are for UV light at a wavelength of 254 nm as produced by a low-pressure mercury vapor lamp. To receive treatment credit for other lamp types, the owner shall demonstrate an equivalent germicidal dose through reactor validation testing as described in subdivision E 7 c (2) of this section. The UV dose values listed in Table 401.7 are applicable only to post-filter applications of UV in filtered waterworks.

| TABLE 401.7 UV Doses for Cryptosporidium, Giardia lamblia and Virus Inactivation Credit | | | | | --- | --- | --- | --- | | LOG CREDIT | CRYPTOSPORIDIUM UV DOSE (mJ/cm2) | GIARDIA LAMBLIA UV DOSE (mJ/cm2) | VIRUS UV DOSE (mJ/cm²) | | 0.5 | 1.6 | 1.5 | 39 | | 1.0 | 2.5 | 2.1 | 58 | | 1.5 | 3.9 | 3.0 | 79 | | 2.0 | 5.8 | 5.2 | 100 | | 2.5 | 8.5 | 7.7 | 121 | | 3.0 | 12 | 11 | 143 | | 3.5 | 15 | 15 | 163 | | 4.0 | 22 | 22 | 186 |

(2) Reactor validation testing. The owner shall use UV reactors that have undergone validation testing to determine the operating conditions under which the reactor delivers the UV dose required in subdivision E 7 c (1) of this section (i.e., validated operating conditions). These operating conditions shall include flow rate, UV intensity as measured by a UV sensor, and UV lamp status.

(a) When determining validated operating conditions, the owner shall account for the following factors: (i) UV absorbance of the water; (ii) lamp fouling and aging; (iii) measurement uncertainty of online sensors; (iv) UV dose distributions arising from the velocity profiles through the reactor; (v) failure of UV lamps or other critical waterworks components; and (vi) inlet and outlet piping or channel configurations of the UV reactor.

(b) Validation testing shall include the following: full-scale testing of a reactor that conforms uniformly to the UV reactors used by the waterworks and inactivation of a test microorganism whose dose-response characteristics have been quantified with a low-pressure mercury vapor lamp.

(c) UV reactor validation testing shall be in accordance with EPA's recommended validation protocol for UV reactors, as described in EPA's "Ultraviolet Disinfection Guidance Manual for the Final Long Term 2 Enhanced Surface Water Treatment Rule," November 2006, EPA Office of Water. Alternative protocols may be considered for approval by the department on a case-by-case basis.

(d) Validation testing, whether onsite or offsite, shall be performed by a third party independent of the UV reactor manufacturer and the owner to ensure that validation testing and data analysis are conducted in a technically sound manner without bias.

(e) To receive credit for lamp types other than low-pressure types, the owner shall demonstrate an equivalent germicidal dose through reactor validation testing.

(f) A validation report shall be submitted and approved by the department to receive disinfection credit.

(3) UV reactor monitoring.

(a) The owner shall monitor the UV reactors to determine if the reactors are operating within validated conditions as determined under subdivision E 7 c (2) of this section. This monitoring shall include UV intensity as measured by a UV sensor, flow rate, lamp status, and other parameters the department designates based on UV reactor operation. The owner shall verify the calibration of UV sensors and shall recalibrate sensors in accordance with a protocol approved by the department.

(b) To receive treatment credit for UV light, the owner shall treat at least 95% of the water delivered to the public during each month by the UV reactors operating within validated conditions for the required UV dose as described in subdivisions E 7 c (1) and E 7 c (2) of this section. The owner shall demonstrate compliance with this condition by the monitoring required under subdivision E 7 c (3) (a) of this section.

F. The owner shall comply with the applicable recordkeeping and reporting requirements described in 12VAC5-590-530, 12VAC5-590-531, 12VAC5-590-550, and 12VAC5-590-570.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-405 Lead and copper treatment techniques

A. Lead and copper corrosion control techniques.

1. Corrosion control treatment requirements. The owner of a community waterworks or a NTNC shall install and operate optimum corrosion control treatment by completing the corrosion control treatment requirements described below which are applicable to these waterworks under subdivision A 2 of this section.

a. Owner's proposal regarding corrosion control treatment. Based upon the results of lead and copper tap monitoring and water quality parameter monitoring, the owner of a small or a medium waterworks exceeding the lead or copper AL shall propose installation of one or more of the corrosion control treatments listed in subdivision A 1 c (1) of this section that the owner believes constitutes optimal corrosion control for that waterworks. The department may require the owner to conduct additional water quality parameter monitoring in accordance with 12VAC5-590-375 C 2 to assist the department in evaluating the proposal.

b. Applicability of studies of corrosion control treatment (applicable to small and medium waterworks). The department may require the owner of a small or a medium waterworks that exceeds the lead or copper AL to perform corrosion control studies under subdivision A 1 cof this section to identify optimal corrosion control treatment for the waterworks.

c. Corrosion control studies.

(1) The owner of a waterworks required by the department to perform corrosion control studies shall evaluate the effectiveness of each of the following treatments, and, if appropriate, combinations of the following treatments to identify the optimal corrosion control treatment for that waterworks:

(a) Alkalinity and pH adjustment;

(b) Calcium hardness adjustment; and

(c) The addition of a phosphate-based or silicate-based corrosion inhibitor at a concentration sufficient to maintain an effective corrosion inhibitor residual concentration in all test tap samples, such that a passivating film is formed on the interior walls of the pipe.

(2) The owner shall evaluate each of the corrosion control treatments using either pipe rig or loop tests, metal coupon tests, partial-system tests, or analyses based on documented analogous treatments with other waterworks of similar size, water chemistry, and distribution system configuration.

(3) The owner shall measure the following water quality parameters in any tests conducted under subdivision A 1 cof this section before and after evaluating the corrosion control treatments listed in subdivision A 1 c (1) of this section:

(a) Lead;

(b) Copper;

(c) pH;

(d) Alkalinity;

(e) Calcium;

(f) Conductivity;

(g) Orthophosphate (when an inhibitor containing a phosphate compound is used);

(h) Silicate (when an inhibitor containing a silicate compound is used); and

(i) Water temperature.

(4) The owner shall identify all chemical or physical constraints that limit or prohibit the use of a particular corrosion control treatment and document such constraints with at least one of the following:

(a) Data and documentation showing that a particular corrosion control treatment has adversely affected other water treatment processes when used by another waterworks with comparable water quality characteristics; or

(b) Data and documentation demonstrating that the owner has previously attempted to evaluate a particular corrosion control treatment and has found that the treatment is ineffective or adversely affects other water quality treatment processes.

(5) The owner shall evaluate the effect of the chemicals used for corrosion control treatment on other water quality treatment processes.

(6) On the basis of an analysis of the data generated during each evaluation, the owner shall propose in writing to the department that the treatment option resulting from the corrosion control studies constitutes optimal corrosion control treatment for that waterworks. The owner shall provide a rationale for the recommendation along with all supporting documentation specified in subdivisions A 1 c (1) through A 1 c (5) of this section.

d. Approval of optimal corrosion control treatment.

(1) Based upon consideration of available information including, where applicable, studies performed under subdivision A 1 c of this section and the owner's proposed treatment alternative, the department shall either approve the corrosion control treatment option recommended by the owner, or designate alternative corrosion control treatment from among those listed in subdivision A 1 c (1) of this section. When approving optimal treatment, the department shall consider the effects that additional corrosion control treatment will have on water quality parameters and on other water quality treatment processes.

(2) The department shall notify the owner of the determination on optimal corrosion control treatment in writing and explain the basis for this determination. If the department requests additional information to aid an evaluation, then the owner shall provide the information.

e. Installation of optimal corrosion control. The owner shall properly install and operate throughout the waterworks the optimal corrosion control treatment approved by the department under subdivision A 1 d of this section. A construction permit is required before installation of any treatment in accordance with 12VAC5-590-200.

f. The department's evaluation of treatment and specification of the optimal water quality control parameters shall consist of the following:

(1) The department shall evaluate the results of all lead and copper tap samples and water quality parameter samples submitted by the owner and determine whether the owner has properly installed and operated the optimal corrosion control treatment approved by the department under subdivision A 1 d of this section. Upon evaluating the results of tap water and water quality parameter monitoring by the owner, both before and after the owner installs optimal corrosion control treatment, the department shall designate:

(a) A minimum value or a range of values for pH measured at each entry point to the distribution system;

(b) A minimum pH value, measured in all tap samples. The value shall be equal to or greater than 7.0, unless the department determines that meeting a pH level of 7.0 is not technologically feasible or is not necessary for the owner to optimize corrosion control;

(c) If a corrosion inhibitor is used, then a minimum concentration or a range of concentrations for the inhibitor, measured at each entry point to the distribution system and in all tap samples, that the department determines is necessary to form a passivating film on the interior walls of the pipes of the distribution system;

(d) If alkalinity is adjusted as part of the optimal corrosion control treatment, then a minimum concentration or a range of concentrations for alkalinity, measured at each entry point to the distribution system and in all tap samples; or

(e) If calcium carbonate stabilization is used as part of the corrosion control, then a minimum concentration or a range of concentrations for calcium, measured in all tap samples.

(2) The values for the applicable water quality control parameters listed in subdivision A 1 c (3) of this section shall be those that the department determines to reflect optimal corrosion control treatment for the waterworks. The department may designate values for additional water quality control parameters determined by the department to reflect optimal corrosion control for the waterworks. The department shall notify the owner in writing of these determinations and explain the basis for the decisions.

g. Continued operation and monitoring. The owner of a waterworks optimizing corrosion control shall continue to operate and maintain optimal corrosion control treatment, including maintaining water quality parameters at or above minimum values or within ranges designated by the department under subdivision A 1 f of this section as verified by all samples collected under 12VAC5-590-375 C 4,12VAC5-590-375 C 5, and 12VAC5-590-375 C 6. Compliance with the requirements of this subdivision shall be determined every six months, as specified under 12VAC5-590-375 C 4. The waterworks is out of compliance with the requirements of this subdivision for a six-month period if excursions occur for any department-specified parameter on more than nine days during the period. An excursion occurs whenever the daily value for one or more of the water quality parameters measured at a sampling location is below the minimum value or outside the range designated by the department. The department has discretion to delete results of obvious sampling errors from this calculation. Daily values shall be calculated as follows:

(1) On days when more than one measurement for the water quality parameter is collected at the sampling location, the daily value shall be the average of all results collected during the day regardless of whether they are collected through continuous monitoring, grab sampling, or a combination of both.

(2) On days when only one measurement for the water quality parameter is collected at the sampling location, the daily value shall be the result of that measurement.

(3) On days when no measurement is collected for the water quality parameter at the sampling location, the daily value shall be the daily value calculated on the most recent day on which the water quality parameter was measured at the sample site.

h. Modification of the department's treatment decisions. Upon the department's initiative or in response to a request by an owner or other interested party, the department may modify the determination of the optimal corrosion control treatment under subdivision A 1 d of this section or optimal water quality control parameters under subdivision A 1 f of this section. A request for modification by an owner or other interested party shall be in writing, explain why the modification is appropriate, and provide supporting documentation. The department may modify the determination where it is concluded that the change is necessary to ensure that the waterworks continues to optimize corrosion control treatment. A revised determination shall be made in writing, set forth the new treatment requirements, explain the basis for the department's decision, and provide an implementation schedule for completing the treatment modifications.

2. Corrosion control treatment steps.

a. The owner shall complete the applicable corrosion control treatment requirements described in subdivision A 1 of this section by the deadlines established in this subdivision.

(1) The owner of a large waterworks (serving greater than 50,000 persons) shall complete the corrosion control treatment steps specified in subdivision A 2 d of this section, unless the owner is deemed to have optimized corrosion control under subdivision A 2 b (2) or A 2 b (3) of this section.

(2) The owner of a small waterworks (serving fewer than or equal to 3300 persons) or a medium waterworks (serving greater than 3,300 and fewer than or equal to 50,000 persons) shall complete the corrosion control treatment steps specified in subdivision A 2 e of this section, unless the owner is deemed to have optimized corrosion control under subdivisions A 2 b (1) through A 2 b (3) of this section.

b. The owner is deemed to have optimized corrosion control and is not required to complete the applicable corrosion control treatment steps identified in this subdivision if the waterworks satisfies one of the criteria specified in subdivisions A 2 b (1) through A 2 b (3) of this section. The owner deemed to have optimized corrosion control under this subdivision and to have treatment in place shall continue to operate and maintain optimal corrosion control treatment and meet any requirements that the department determines appropriate to ensure optimal corrosion control treatment is maintained.

(1) The owner of a small or a medium waterworks is deemed to have optimized corrosion control if the waterworks meets the lead and copper ALs during each of two consecutive six-month monitoring periods conducted in accordance with 12VAC5-590-375.

(2) The owner may be deemed by the department to have optimized corrosion control treatment if the owner demonstrates to the satisfaction of the department that the owner has conducted activities equivalent to the corrosion control steps applicable to the waterworks under this section. If the department makes this determination, then the owner shall be provided with a written notice explaining the basis for the decision and the notice shall specify the water quality control parameters representing optimal corrosion control in accordance with subdivision A 1 f of this section. The owner deemed to have optimized corrosion control under this subdivision shall operate in compliance with the department designated optimal water quality control parameters in accordance with subdivision A 1 g and continue to conduct lead and copper tap and water quality parameter sampling in accordance with 12VAC5-590-375 B 4 c and 12VAC5-590-375 C 4, respectively. The owner shall provide the department with the following information to support a determination under this subdivision:

(a) The results of all test samples collected for each of the water quality parameters in subdivision A 1 c (3) of this section;

(b) A report explaining the test methods used by the owner to evaluate the corrosion control treatments listed in subdivision A 1 c (1) of this section, the results of all tests conducted, and the basis for the owner's selection of optimal corrosion control treatment;

(c) A report explaining how corrosion control has been installed and how it is being maintained to insure minimal lead and copper concentrations at consumers' taps; and

(d) The results of tap water samples collected in accordance with 12VAC5-590-375 B at least once every six months for one year after corrosion control treatment has been installed.

(3) A waterworks is deemed to have optimized corrosion control if the owner submits results of tap water monitoring conducted in accordance with 12VAC5-590-375 B and source water monitoring conducted in accordance with 12VAC5-590-375 D that demonstrates for two consecutive six-month monitoring periods that the difference between the 90th percentile tap water lead level, computed under 12VAC5-590-385 C, and the highest source water lead concentration is less than the PQL for lead (0.005 mg/L).

(a) The owner that submits monitoring results indicating that the highest source water lead level is below the MDL may also be deemed to have optimized corrosion control under this subdivision if the 90th percentile tap water lead level is less than or equal to the PQL for lead (0.005 mg/L) for two consecutive six-month monitoring periods.

(b) The owner deemed to have optimized corrosion control under this subdivision shall continue monitoring for lead and copper at the tap no less frequently than once every three calendar years using the reduced number of sites specified in 12VAC5-590-375 B 3 and collecting the samples at times and locations specified in 12VAC5-590-375 B 4 d (4).

(c) The owner deemed to have optimized corrosion control pursuant to this subdivision shall notify the department in writing pursuant to 12VAC5-590-532 B 3 of any upcoming long-term change in treatment or addition of a new source water as described in 12VAC5-590-532 B 3. The department shall evaluate and approve the addition of a new source water or long-term change in water treatment before it is implemented by the owner. The department may require the owner of a waterworks to conduct additional monitoring or to take other actions the department deems appropriate to ensure that minimum levels of corrosion control are being maintained in the distribution system.

(d) The owner is not deemed to have optimized corrosion control under this subdivision, and shall implement corrosion control treatment specified in subdivision A 2 b (3) (e) of this section, unless the copper AL is met.

(e) The owner of a waterworks triggered into corrosion control because the waterworks is no longer deemed to have optimized corrosion control under this subsection shall implement corrosion control treatment in accordance with the deadlines in subdivision A 2 e of this section. The owner of a large waterworks shall adhere to the schedule specified in subdivision A 2 e of this section for a medium waterworks, with the time period for completing each step being triggered by the date the owner is no longer deemed to have optimized corrosion control treatment under this subsection.

c. The owner of a small or a medium waterworks that is required to complete the corrosion control steps due to the exceedance of the lead or copper AL may cease completing the treatment steps whenever the waterworks meets both ALs during each of two consecutive six-month monitoring periods conducted pursuant to 12VAC5-590-375 B 4 a and submits the results to the department. If a waterworks thereafter exceeds the lead or copper AL during any monitoring period, the owner shall recommence completion of the applicable treatment steps, beginning with the first treatment step that was not previously completed in its entirety. The department may require the owner to repeat treatment steps previously completed where the department determines that this is necessary to properly implement the treatment requirements of this section. The department shall notify the owner in writing of the determination and explain the basis for the decision. The requirement for the owner of a small or a medium waterworks to implement corrosion control treatment steps in accordance with subdivision A 2 e of this section (including waterworks deemed to have optimized corrosion control under subdivision A 2 b (1) of this section) is triggered whenever a small or a medium waterworks exceeds the lead or copper AL.

d. Treatment steps and deadlines for large waterworks. Except as provided in subdivisions A 2 b (2) and A 2 b (3) of this section, the owner of a large waterworks shall complete the following corrosion control treatment steps (described in the referenced portions of subdivision A 1 of this section, 12VAC5-590-375 B,and 12VAC5-590-375 C).

(1) Step 1: The owner shall conduct initial monitoring (12VAC5-590-375 B 4 a and 12VAC5-590-375 C 2) during two consecutive six-month monitoring periods by a date specified by the department.

(2) Step 2: The owner shall complete corrosion control studies (subdivision A 1 c of this section) and submit the study and recommendations to the department no later than 18 months after the date that initial monitoring is completed as specified in Step 1.

(3) Step 3: The department shall approve optimal corrosion control treatment (subdivision A 1 d of this section) no later than 12 months following receipt of the corrosion control study required in Step 2.

(4) Step 4: The owner shall install optimal corrosion control treatment (subdivision A 1 e of this section) no later than 24 months following the department's approval of optimal corrosion control treatment specified in Step 3.

(5) Step 5: The owner shall complete follow-up sampling (12VAC5-590-375 B 4 b and 12VAC5-590-375 C 3) no later than 12 months following the installation of optimal corrosion control treatment specified in Step 4.

(6) Step 6: The department shall evaluate the installation of treatment and designate optimal water quality control parameters (subdivision A 1 f of this section) no later than six months following completion of follow-up sampling specified in Step 5.

(7) Step 7: The owner shall operate the waterworks in compliance with the department-specified optimal water quality control parameters (subdivision A 1 g of this section) and continue to conduct tap sampling (12VAC5-590-375 B 4 c and 12VAC5-590-375 C 4).

e. Treatment steps and deadlines for small and medium waterworks. Except as provided in subdivision A 2 b of this section, the owner of a small or a medium waterworks shall complete the following corrosion control treatment steps (described in the referenced portions of subdivision A 1 of this section, 12VAC5-590-375 B,and 12VAC5-590-375 C):

(1) The owner shall conduct initial tap sampling (12VAC5-590-375 B 4 a and 12VAC5-590-375 C 2) until the waterworks either exceeds the lead or copper AL or becomes eligible for reduced monitoring under 12VAC5-590-375 B 4 d. The owner of a waterworks exceeding the lead or copper AL shall propose optimal corrosion control treatment (subdivision A 1 a of this section) within six months after the end of the monitoring period during which it exceeds one of the ALs.

(2) Within 12 months after the end of the monitoring period during which a waterworks exceeds the lead or copper AL, the department may require the owner to perform corrosion control studies (subdivision A 1 b of this section). If the department does not require the owner to perform these studies, the department shall specify optimal corrosion control treatment (subdivision A 1 d of this section) within the following timeframes:

(a) For a medium waterworks, within 18 months after the end of the monitoring period during which the waterworks exceeds the lead or copper AL.

(b) For a small waterworks, within 24 months after the end of the monitoring period during which the waterworks exceeds the lead or copper AL.

(3) If the department requires the owner to perform corrosion control studies under subdivision A 2 e (2) of this section, then the owner shall complete the studies (subdivision A 1 c of this section) and submit the study and recommendations to the department within 18 months after the department requires that the studies be conducted.

(4) If the owner has performed corrosion control studies under subdivision A 2 e (2) of this section, then the department shall designate optimal corrosion control treatment (subdivision A 1 d of this section) within six months after completion of the provisions of subdivision A 2 e (3) of this section.

(5) The owner shall install optimal corrosion control treatment (subdivision A 1 e of this section) within 24 months after the department designates such treatment. A construction permit is required before installation of any treatment, in accordance with 12VAC5-590-200.

(6) The owner shall complete follow-up sampling (12VAC5-590-375 B 4 b and 12VAC5-590-375 C 3) within 36 months after the department designates optimal corrosion control treatment.

(7) The department shall evaluate the owner's installation of treatment and designate optimal water quality control parameters (subdivision A 1 f of this section) within six months after completion of the provisions of subdivision A 2 e (6) of this section.

(8) The owner shall operate the waterworks in compliance with the department-designated optimal water quality control parameters (subdivision A 1 g of this section) and continue to conduct tap sampling (12VAC5-590-375 B 4 c and 12VAC5-590-375 C 4).

B. Source water treatment technique requirements for lead and copper. The owner of a waterworks exceeding the lead or copper AL shall complete the applicable source water monitoring and treatment requirements (described in the referenced portions of subdivision B 2 of this section, and in 12VAC5-590-375 B and 12VAC5-590-375 D) by the following deadlines:

1. Deadlines for completing source water treatment steps.

a. The owner of a waterworks exceeding the lead or copper AL shall complete lead and copper source water monitoring (12VAC5-590-375 D 2) and submit a treatment proposal to the department (subdivision B 2 a of this section) no later than 180 days after the end of the monitoring period during which the lead or copper AL was exceeded.

b. The department shall make a determination regarding the need for source water treatment (subdivision B 2 b of this section) within six months after submission of monitoring results under subdivision B 1 a of this section.

c. If the department requires installation of source water treatment, then the owner shall install the treatment (subdivision B 3 of this section) within 24 months after completion of subdivision B 1 b of this section.

d. The owner shall complete follow-up tap water monitoring (12VAC5-590-375 B 4 b) and source water lead and copper monitoring (12VAC5-590-375 D 3) within 36 months after completion of subdivision B 1 b.

e. The department shall evaluate the owner's installation and operation of the source water treatment and specify maximum permissible source water lead and copper levels (subdivision B 4 of this section) within six months after completion of subdivision B 1 d of this section.

f. The owner shall operate the waterworks in compliance with the department-specified maximum permissible source water lead and copper levels (subdivision B 4 of this section) and continue source water monitoring (12VAC5-590-375 D 4).

2. Description of source water treatment requirements.

a. Waterworks treatment recommendation. The owner of a waterworks that exceeds the lead or copper AL shall propose in writing to the department the installation and operation of one of the source water treatments listed in subdivision B 2 b of this section. The owner may propose that no treatment be installed based upon a demonstration that source water treatment is not necessary to minimize lead and copper levels at consumer taps.

b. Department's determination regarding source water treatment. The department shall complete an evaluation of the results of all source water samples submitted by the owner to determine whether source water treatment is necessary to minimize lead or copper levels in water delivered to consumer taps. If the department determines that treatment is needed, then the department shall either require installation and operation of the source water treatment recommended by the owner or require the installation and operation of another source water treatment from among the following: (i) ion exchange, (ii) RO, (iii) lime softening, or (iv) coagulation or filtration. If the department requests additional information to aid in the evaluation, then the owner shall provide the information by the date specified by the department in the request. The department shall notify the owner in writing of the determination and set forth the basis for the decision.

3. Installation of source water treatment. The owner shall properly install and operate the source water treatment designated by the department under subdivision B 2 b of this section.

4. The department's evaluation of source water treatment and specification of maximum permissible source water lead and copper levels. The department shall evaluate the source water samples collected by the owner both before and after the owner installs source water treatment, and determine whether the owner has properly installed and operated the source water treatment designated by the department. Based upon the evaluation, the department shall designate the maximum permissible lead and copper concentrations for finished water entering the distribution system. The levels shall reflect the contaminant removal capability of the treatment properly operated and maintained. The department shall notify the owner in writing and explain the basis for the decision.

5. Continued operation and maintenance. The waterworks shall be operated to maintain lead and copper levels below the maximum permissible concentrations designated by the department at each sampling point monitored in accordance with 12VAC5-590-375 D. The waterworks is out of compliance with this subdivision B 5 if the level of lead or copper at any sampling point is greater than the maximum permissible concentration designated by the department.

6. Modification of the department's treatment decisions. Upon the department's initiative or in response to a request by an owner or other interested party, the department may modify the determination of the source water treatment under subdivision B 2 b of this section, or may modify the maximum permissible lead and copper concentrations for finished water entering the distribution system under subdivision B 4 of this section. A request for modification by an owner or other interested party shall be in writing, explain why the modification is appropriate, and provide supporting documentation. The department may modify the determination where the conclusion is made that the change is necessary to ensure that the waterworks continues to minimize lead and copper concentrations in source waters. A revised determination shall be made in writing, set forth the new treatment requirements, explain the basis for the department's decision, and provide an implementation schedule for completing the treatment modifications.

C. Lead service line replacement treatment technique requirements:

1. The owner of a waterworks that fails to meet the lead AL in tap samples collected pursuant to 12VAC5-590-375 B 4 b, after installing corrosion control or source water treatment (whichever sampling occurs later), shall replace lead service lines in accordance with the requirements of this section. If the owner is in violation of subdivision A 2 of this section or subsection B of this section for failure to install source water or corrosion control treatment, then the department may require the owner to commence lead service line replacement under this section after the date by which the owner was required to conduct monitoring under 12VAC5-590-375 B 4 b has passed.

2. The owner shall replace annually at least 7.0% of the initial number of lead service lines in its distribution system. The initial number of lead service lines is the number of lead lines in place at the time the replacement program begins. The owner shall identify the initial number of lead service lines in its distribution system based upon a materials evaluation, including the evaluation required under 12VAC5-590-375 B 1. The first year of lead service line replacement shall begin on the first day following the end of the monitoring period in which the lead AL was exceeded under subdivision C 1 of this section. If monitoring is required annually or less frequently, then the end of the monitoring period is September 30 of the calendar year in which the sampling occurs. If the department has established an alternate monitoring period, then the end of the monitoring period will be the last day of that period.

3. The owner of a waterworks resuming a lead service line replacement program after the cessation of the lead service line replacement program as allowed by subdivision C 7 of this section shall update the inventory of lead service lines to include those sites that were previously determined not to require replacement through the sampling provision under subdivision C 4 of this section. The owner shall then divide the updated number of remaining lead service lines by the number of remaining years in the program to determine the number of lines that must be replaced per year (7.0% lead service line replacement is based on a 15-year replacement program; so, for example, the owner resuming lead service line replacement after previously conducting two years of replacement would divide the updated inventory by 13). For the owner that has completed a 15-year lead service line replacement program, the department will determine a schedule for replacing or retesting lines that were previously tested out under the replacement program when the waterworks re-exceeds the lead AL.

4. The owner is not required to replace an individual lead service line if the lead concentration in all service line samples from that line, collected pursuant to 12VAC5-590-375 B 2 c, is less than or equal to 0.015 mg/L.

5. The owner shall replace that portion of the lead service line that is owned by the waterworks. In cases where the owner does not own the entire lead service line, the owner shall notify the building owner, or the building owner's authorized agent, that the owner will replace that portion of the service line that is owned by the waterworks and shall offer to replace the building owner's portion of the line. The owner is not required to bear the cost of replacing the building owner's portion of the service line, nor is the owner required to replace the building owner's portion where the owner chooses not to pay the cost of replacing the building owner's portion of the line, or where replacing the building owner's portion would be precluded by state, local, or common law. The owner that does not replace the entire length of the service line also shall complete the following tasks:

a. At least 45 days before commencing with the partial replacement of a lead service line, the owner shall provide notice to the resident or residents of all buildings served by the line explaining that they may experience a temporary increase of lead levels in the drinking water, along with guidance on measures consumers can take to minimize their exposure to lead. The department may allow the owner to provide notice under the previous sentence less than 45 days before commencing partial lead service line replacement where the replacement is in conjunction with emergency repairs. In addition, the owner shall inform each resident served by the lead service line that the owner will, at the owner's expense, collect a sample from each partially replaced lead service line that is representative of the water in the service line for analysis of lead content, as prescribed in 12VAC5-590-375 B 2 c, within 72 hours after the completion of the partial replacement of the lead service line. The owner shall collect the sample and report the results of the analysis to the building owner and each resident served by the service line within three business days of receiving the results. Mailed notices post-marked within three business days of receiving the results shall be considered on time.

b. The owner shall provide the information required by subdivision C 5 a of this section to the residents of individual dwellings by mail or by other methods approved by the department. In instances where multi-family dwellings are served by the service line, the owner shall have the option to post the information at a conspicuous location.

6. The department shall require the owner to replace lead service lines on a shorter schedule than that required by this subsection, taking into account the number of lead service lines in the waterworks, where a shorter replacement schedule is feasible. The department shall make this determination in writing and notify the owner of the findings within six months after the waterworks is triggered into lead service line replacement based on monitoring referenced in subdivision C 1 of this section.

7. The owner may cease replacing lead service lines whenever first-draw tap samples collected pursuant to 12VAC5-590-375 B 2 b meet the lead AL during each of two consecutive six-month monitoring periods and the owner submits the results to the department. If the first-draw tap samples collected in a waterworks thereafter exceed the lead AL, then the owner shall recommence replacing lead service lines, pursuant to subdivision C 3 of this section.

8. To demonstrate compliance with subdivisions C 1 through C 5 of this section, an owner shall report to the department the information specified in 12VAC5-590-532.

D. Lead public education requirements. The owner shall deliver a consumer notice of lead tap water monitoring results to all persons served by the waterworks at sites that are tested in accordance with subdivision D 4 of this section. The owner of a waterworks that exceeds the lead AL based on tap water samples collected in accordance with 12VAC5-590-375 B shall deliver the public education materials contained in subdivision D 1 of this section in accordance with the requirements in subdivision D 2 of this section. The owner of a waterworks that exceeds the lead AL shall sample the tap water of any customer who requests it in accordance with subdivision D 3 of this section.

1. Content of written materials. The owner shall include the following text in all of the printed materials distributed through the lead public education program:

a. Community waterworks and NTNCs. The owner of community waterworks or a NTNC shall include the following elements in printed materials (e.g., brochures and pamphlets) in the same order as listed in this subdivision D 1 a. In addition, the language specified in subdivisions D 1 a (1) and D 1 a (2) and in subdivision D 1 a (6) of this section shall be included in materials, exactly as written, except for the text in brackets for which the owner shall include system-specific information. Any additional information presented by the owner shall be consistent with the information in this subdivision D 1 a and be in plain language that can be understood by the general public. The department may require the owner to obtain approval of the content of written material before delivery.

(1) IMPORTANT INFORMATION ABOUT LEAD IN YOUR DRINKING WATER. "(Insert name of waterworks) found elevated levels of lead in drinking water in some homes or buildings. Lead can cause serious health problems, especially for pregnant women and young children. Please read this information closely to see what you can do to reduce lead in your drinking water."

(2) Health effects of lead. "Lead can cause serious health problems if too much enters your body from drinking water or other sources. It can cause damage to the brain and kidneys, and can interfere with the production of red blood cells that carry oxygen to all parts of your body. The greatest risk of lead exposure is to infants, young children, and pregnant women. Scientists have linked the effects of lead on the brain with lowered IQ in children. Adults with kidney problems and high blood pressure can be affected by low levels of lead more than healthy adults. Lead is stored in the bones, and it can be released later in life. During pregnancy, the child receives lead from the mother's bones, which may affect brain development."

(3) Sources of lead.

(a) Explain what lead is.

(b) Explain possible sources of lead in drinking water and how lead enters drinking water. Include information on home or building materials and services lines that may contain lead.

(c) Discuss other important sources of lead exposure in addition to drinking water (e.g., paint).

(4) Discuss the steps the consumer can take to reduce their exposure to lead in drinking water.

(a) Encourage running the water to flush out the lead.

(b) Explain concerns with using hot water from the tap and specifically caution against the use of hot water for preparing baby formula.

(c) Explain that boiling water does not reduce lead levels.

(d) Discuss other options consumers can take to reduce exposure to lead in drinking water, such as alternative sources or treatment of water.

(e) Suggest that parents have their child's blood tested for lead.

(5) Explain why there are elevated levels of lead in the waterworks' drinking water (if known) and what the owner is doing to reduce the lead levels in homes and buildings.

(6) "For more information call us at (Insert owner's contact phone number), or if applicable, visit our website at (Insert waterworks' website URL here). For more information on reducing lead exposure around your home or building and the health effects of lead, visit EPA's website at http://www.epa.gov/lead or contact your health care provider."

b. In addition to including the elements specified in subdivision D 1 a of this section, the owner of a community waterworks shall:

(1) Tell consumers how to get their water tested.

(2) Discuss lead in plumbing components and the difference between low lead and lead free. "Lead free" means (i) when used with respect to solders and flux refers to solders and flux containing not more than 0.2% lead, and (ii) when used with respect to pipes, pipe fittings, plumbing fittings, and plumbing fixtures refers to the weighted average of wetted surfaces of pipes, pipe fittings, plumbing fittings, and plumbing fixtures containing not more than 0.25% lead.

2. Delivery of public education materials.

a. The owner of a waterworks serving a large proportion of non-English speaking consumers, as determined by the department, shall include in all public education materials information in the appropriate languages regarding the importance of the notice or contain a telephone number or address where persons served may contact the waterworks to obtain a translated copy of the public education materials or to request assistance in the appropriate language.

b. The owner of a community waterworks that exceeds the lead AL on the basis of tap water samples collected in accordance with 12VAC5-590-375 B, and that is not already conducting public education tasks, shall conduct the public education tasks under this subdivision within 60 days after the end of the monitoring period in which the exceedance occurred. For a waterworks that is required to conduct monitoring annually or less frequently, the end of the monitoring period is September 30 of the calendar year in which the sampling occurs, or, if the department has established an alternate monitoring period, the last day of that period. These public education tasks include:

(1) Delivering printed materials meeting the content requirements of subdivision D 1 of this section to all bill paying customers.

(2) Contacting customers who are most at risk by delivering education materials that meet the content requirements of subdivision D 1 of this section to the local health department even if they are not located within the waterworks service area, along with an informational notice that encourages distribution to all the organization's potentially affected customers or community waterworks consumers. The owner shall contact the local health department directly by phone or in person. The local health department may provide a specific list of additional community based organizations serving target populations, which may include organizations outside the service area of the waterworks. If these lists are provided, then the owner shall deliver education materials that meet the content requirements of subdivision D 1 of this section to all organizations on the provided lists.

(3) Contacting customers who are most at risk by delivering materials that meet the content requirements of subdivision D 1 of this section to the following organizations that are located within the waterworks service area, along with an informational notice that encourages distribution to all the organization's potentially affected customers or community waterworks users: (i) public and private schools or school boards; (ii) Women, Infants and Children (WIC) and Head Start programs; (iii) public and private hospitals and medical clinics; (iv) pediatricians; (v) family planning clinics; and (vi) local welfare agencies.

(4) Make a good faith effort to locate the following organizations within the service area and deliver materials that meet the content requirements of subdivision D 1 of this section to them, along with an informational notice that encourages distribution to all potentially affected customers or consumers. The good faith effort to contact at-risk customers may include requesting a specific contact list of these organizations from the local health department, even if the agencies are not located within the waterworks service area: (i) licensed childcare centers, (ii) public and private preschools, and (iii) obstetricians-gynecologists and midwives.

(5) No less often than quarterly, providing information on or in each water bill as long as the waterworks exceeds the AL for lead. The message on the water bill shall include the following statement exactly as written except for the text in brackets for which the owner shall include system-specific information: "(Insert name of waterworks) found high levels of lead in drinking water in some homes. Lead can cause serious health problems. For more information please call (insert name of waterworks) or (if applicable) visit our website at (insert waterworks website URL here)". The message or delivery mechanism can be modified in consultation with the department; specifically, the department may allow a separate mailing of public education materials to customers if the owner cannot place the information on water bills.

(6) Posting materials meeting the content requirements of subdivision D 1 of this section on the waterworks website if the waterworks serves a population greater than 100,000 persons.

(7) Submitting a press release to newspapers, television, and radio stations.

(8) In addition to the delivery requirements contained in subdivisions D 2 b (1) through D 2 b (7) of this section, the owner of a waterworks exceeding the lead AL shall implement at least three activities from one or more of the following categories: (i) public service announcements, (ii) paid advertisements, (iii) public area informational displays, (iv) emails to customers, (v) public meetings, (vi) household deliveries, (vii) targeted individual customer contact, (viii) direct material distribution to all multi-family homes and institutions, and (ix) other methods approved by the department. The educational content and selection of these activities shall be determined in consultation with the department.

(9) As long as a community waterworks exceeds the lead AL, the owner shall repeat the following public education activities:

(a) The owner of a community waterworks shall repeat the tasks contained in subdivisions D 2 b (1), D 2 b (2), D 2 b (3), and D 2 b (8) of this section every 12 months.

(b) The owner of a community waterworks shall repeat tasks contained in subdivision D 2 b (5) of this section with each billing cycle.

(c) The owner of a community waterworks serving a population greater than 100,000 shall post and retain the material on a publicly accessible website pursuant to subdivision D 2 b (6) of this section.

(d) The owner of a community waterworks shall repeat the task in subdivision D 2 b (7) of this section twice every 12 months on a schedule agreed upon with the department.

(10) The department may allow the public education activities described in subdivision D 2 b of this section to extend beyond the 60-day requirement if needed for implementation purposes on a case-by-case basis; however, this extension must be approved in writing by the department in advance of the 60-day deadline.

c. The owner of a NTNC that exceeds the lead AL on the basis of tap water samples collected in accordance with 12VAC5-590-375 B, and that is not already conducting public education tasks, shall conduct the public education tasks under this subdivision within 60 days after the end of the monitoring period in which the exceedance occurred. For a waterworks that is required to conduct monitoring annually or less frequently, the end of the monitoring period is September 30 of the calendar year in which the sampling occurs, or, if the department has established an alternate monitoring period, the last day of that period. These public education tasks include:

(1) Posting informational posters containing all of the public education elements contained in subdivision D 1 of this section in a public place or common area in each of the buildings served by the waterworks; and

(2) Distributing informational pamphlets or brochures on lead in drinking water containing all of the public education elements in subdivision D 1 of this section to each person served by the NTNC. The department may allow the owner to utilize electronic transmission instead of or combined with printed materials as long as it achieves at least the same coverage.

(3) The owner of a NTNC shall repeat the tasks contained in subdivisions D 2 c (1) and D 2 c (2) of this section at least once during each calendar year in which the waterworks exceeds the lead AL.

(4) The department may allow the public education activities described in subdivision D 2 c of this section to extend beyond the 60-day requirement if needed for implementation purposes on a case-by-case basis; however, this extension must be approved in writing by the department in advance of the 60-day deadline.

d. The owner may discontinue delivery of public education materials if the waterworks has met the lead AL during the most recent six-month monitoring period conducted pursuant to 12VAC5-590-375 B. The owner shall recommence public education in accordance with this subsection if the waterworks subsequently exceeds the lead AL during any monitoring period.

e. The owner of a community waterworks may apply to the department, in writing, (unless the department has waived the requirement for prior approval) to use only the text specified in subdivision D 1 a of this section instead of the text in subdivisions D 1 a and D 1 b of this section and to perform the tasks listed in subdivisions D 2 c (1) and D 2 c (2) of this section instead of the tasks in subdivisions D 2 b (1) through D 2 b (9) of this section if:

(1) The waterworks serves a facility, such as a prison or a hospital, where the population served is not capable of or is prevented from making improvements to plumbing or installing POU treatment devices; and

(2) The owner provides water as part of the cost of services provided and does not separately charge for water consumption.

f. The owner of a community waterworks serving 3,300 or fewer people may limit certain aspects of the public education programs as follows:

(1) With respect to the requirements of subdivision D 2 b (8) of this section, the owner of a waterworks serving 3,300 or fewer people shall implement at least one of the activities listed in that subdivision.

(2) With respect to the requirements of subdivision D 2 b (2) of this section, the owner of a waterworks serving 3,300 or fewer people may limit the distribution of the public education materials required under that subdivision to facilities and organizations served by the waterworks that are most likely to be visited regularly by pregnant women and children.

(3) With respect to the requirements of subdivision D 2 b (7) of this section, the department may waive this requirement for waterworks serving 3,300 or fewer persons as long as the owner distributes notices to every household served by the waterworks.

3. Supplemental monitoring and notification of results. The owner of a waterworks that fails to meet the lead AL on the basis of tap samples collected in accordance with 12VAC5-590-375 B shall offer to sample the tap water of any customer who requests it. The owner is not required to pay for collecting or analyzing the sample, nor is the owner required to collect and analyze the sample itself.

4. Notification of results. The owner of a community waterworks or a NTNC shall provide a notice of the individual tap results from lead tap water monitoring carried out under the requirements of 12VAC5-590-375 B to the persons served by the waterworks at the specific sampling site from which the sample was collected (e.g., the occupants of the residence or buildings where the tap was tested).

a. Timing of notification. The owner shall provide this consumer notice as soon as practical, but no later than 30 days after the owner learns of the tap monitoring results.

b. Content. The consumer notice shall include the results of lead tap water monitoring for the tap that was tested, an explanation of the health effects of lead, list steps consumers can take to reduce exposure to lead in drinking water, and contact information for the waterworks. The notice shall also provide the MCLG and the AL for lead and the definitions for these two terms from 12VAC5-590-10.

c. Delivery. The consumer notice shall be provided to persons served at the tap that was tested, either by postal mail or by another method approved by the department. For example, the owner of a NTNC may post the results on a bulletin board in the facility to allow consumers to review the information. The owner shall provide the notice to customers at sample taps tested, including consumers who do not receive water bills.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 27, Issue 1, eff. October 13, 2010; amended, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-410 (Repealed.)

History

• Historical Notes: Derived from VR355-18-004.08 § 2.8, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 12, Issue 2, eff. November 15, 1995; Volume 18, Issue 19, eff. July 3, 2002; Volume 19, Issue 24, eff. September 10, 2003; Volume 21, Issue 13, eff. April 6, 2005; Volume 22, Issue 15, eff. May 3, 2006; Volume 22, Issue 24, eff. September 6, 2006; Volume 25, Issue 5, eff. December 10, 2008; Volume 27, Issue 1, eff. October 13, 2010; Volume 28, Issue 5, eff. December 7, 2011; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-411 Disinfection byproduct precursors, disinfection byproducts, and maximum residual disinfection level treatment techniques

A. Treatment technique for control of DBPPs.

1. Applicability.

a. The owner of a community waterworks or a NTNC shall comply with treatment techniques for the control of DBPPs.

b. A waterworks that uses a surface water source, a GUDI source, or both using conventional filtration treatment shall operate with enhanced coagulation or enhanced softening to achieve the TOC percentage removal levels specified in subdivision A 2 of this section unless the waterworks meets at least one of the alternative compliance criteria listed in subdivision A 1 c or A 1 d of this section.

c. Alternative compliance criteria for enhanced coagulation and enhanced softening waterworks. A waterworks that uses a surface water source, a GUDI source, or both provided with conventional filtration treatment may use the alternative compliance criteria in subdivisions A 1 c (1) through A 1 c (6) of this section to comply with this section instead of complying with subdivision A 2 of this section. The owner shall comply with monitoring requirements in 12VAC5-590-374 I.

(1) The waterworks' source water TOC level is less than 2.0 mg/L, calculated quarterly as an RAA.

(2) The waterworks' treated water TOC level is less than 2.0 mg/L, calculated quarterly as an RAA.

(3) The waterworks' source water TOC level is less than 4.0 mg/L, calculated quarterly as an RAA; the source water alkalinity is greater than 60 mg/L (as CaCO₃), calculated quarterly as an RAA; and no TTHM and HAA5 LRAAs are greater than 0.040 mg/L and 0.030 mg/L, respectively.

(4) No TTHM and HAA5 LRAAs are greater than 0.040 mg/L and 0.030 mg/L, respectively, and the waterworks uses only chlorine for primary disinfection and maintains a residual in the distribution system.

(5) The waterworks' source water SUVA, before any treatment and measured monthly, is less than or equal to 2.0 liters per milligram-meter (L/mg-m), calculated quarterly as an RAA.

(6) The waterworks' finished water SUVA, measured monthly, is less than or equal to 2.0 L/mg-m, calculated quarterly as an RAA.

d. Additional alternative compliance criteria for softening waterworks. A waterworks practicing enhanced softening that cannot achieve the TOC removals required by subdivision A 2 b of this section may use the alternative compliance criteria in subdivisions A 1 c (1) and A 1 c (2) instead of complying with subdivision A 2 of this section. A waterworks shall comply with monitoring requirements in 12VAC5-590-374 J.

(1) Softening that results in lowering the treated water alkalinity to less than 60 mg/L (as CaCO3), measured monthly and calculated quarterly as an RAA.

(2) Softening that results in removing at least 10 mg/L of magnesium hardness (as CaCO3), measured monthly and calculated quarterly as an RAA.

2. Enhanced coagulation and enhanced softening performance requirements.

a. A waterworks shall achieve the percentage reduction of TOC specified in subdivision A 2 b of this section between the source water and the CFE, unless the department approves an owner's request for alternate minimum TOC removal (Step 2) requirements under subdivision A 2 c of this section.

Required Step 1 TOC reductions, indicated in Table 411.1, are based upon specified source water parameters. A waterworks practicing softening is required to meet the Step 1 TOC reductions in the far-right column (source water alkalinity greater than 120 mg/L) for the specified source water TOC.

b. Required Step 1 TOC reductions are indicated in Table 411.1, Required Percentage Removals of TOC.

| TABLE 411.1 Required Percentage Removals of TOC^a,b | | | | | --- | --- | --- | --- | | SOURCE WATER TOC, mg/L | SOURCE WATER ALKALINITY, mg/L as CaCO₃ | | | | 0 - 60 | >60 - 120 | >120^c | | | >2.0 - 4.0 | 35.0% | 25.0% | 15.0% | | >4.0 - 8.0 | 45.0% | 35.0% | 25.0% | | >8.0 | 50.0% | 40.0% | 30.0% | | ^aA waterworks meeting at least one of the conditions in subdivisions A 1 c (1) through A 1 c (6) of this section is not required to operate with enhanced coagulation. ^bA waterworks utilizing softening and meeting one of the alternative compliance criteria in subdivision A 1 d of this section is not required to operate with enhanced softening. ^cA waterworks practicing softening shall meet the TOC removal requirements in this column. | | | |

c. A waterworks that uses a surface water source, a GUDI source, or both with conventional treatment that cannot achieve the Step 1 TOC removals required by subdivision A 2 b due to water quality parameters or operational constraints shall apply to the department within three months of failure to achieve the TOC removals required by subdivision A 2 b of this section for approval of alternative minimum TOC (Step 2) removal requirements submitted by the owner. If the department approves the alternative minimum TOC removal (Step 2) requirements, then the department may make those requirements retroactive for the purposes of determining compliance. Until the department approves the alternate minimum TOC removal (Step 2) requirements, the waterworks shall meet the Step 1 TOC removals contained in subdivision A 2 b of this section.

d. Alternate minimum TOC removal (Step 2) requirements. Applications made to the department by the owner of a waterworks using enhanced coagulation for approval of alternative minimum TOC removal (Step 2) requirements under subdivision A 2 c of this section shall include, at a minimum, results of bench-scale or pilot-scale testing conducted under subdivision A 2 d (1) of this section. The submitted bench-scale or pilot-scale testing shall be used to determine the alternate enhanced coagulation level.

(1) Alternate enhanced coagulation level is defined as coagulation at a coagulant dose and pH as determined by the method described in subdivisions A 2 d (1) through A 2 d (5) of this section so that an incremental addition of 10 mg/L of alum (or equivalent amount of ferric salt) results in a TOC removal of equal to or less than 0.3 mg/L. The percentage removal of TOC at this point on the "TOC removal versus coagulant dose" curve is then defined as the minimum TOC removal required for the waterworks. Once approved by the department, this minimum requirement supersedes the minimum TOC removal requirements listed in Table 411.1. This requirement shall be effective until the department approves a new value based on the results of a new bench-scale and pilot-scale test. Failure to achieve the alternative minimum TOC removal levels set by the department is a violation of this section.

(2) Bench-scale or pilot-scale testing of enhanced coagulation shall be conducted by using representative water samples and adding 10 mg/L increments of alum (or equivalent amounts of ferric salt) until the pH is reduced to a level less than or equal to the enhanced coagulation Step 2 target pH shown in Table 411.2.

| | TABLE 411.2 Enhanced Coagulation | | | --- | --- | --- | | | ALKALINITY (mg/L as CaCO3) | TARGET pH | | | 0 - 60 | 5.5 | | | >60 -120 | 6.3 | | | >120 - 240 | 7.0 | | | >240 | 7.5 |

(3) For source waters with alkalinities of less than 60 mg/L for which addition of small amounts of alum or equivalent addition of iron coagulant drives the pH below 5.5 before significant TOC removal occurs, the waterworks shall add necessary chemicals to maintain the pH between 5.3 and 5.7 in samples until the TOC removal of 0.3 mg/L per 10 mg/L alum added (or equivalent addition of iron coagulant) is reached.

(4) The waterworks may operate at any coagulant dose or pH necessary (consistent with other sections of this chapter) to achieve the minimum TOC percentage removal approved under subdivision A 2 c of this section.

(5) If the TOC removal is consistently less than 0.3 mg/L of TOC per 10 mg/L of incremental alum dose at all dosages of alum (or equivalent addition of iron coagulant), then the water is deemed to contain TOC not amenable to enhanced coagulation. The owner may then apply to the department for a waiver of enhanced coagulation requirements.

3. Compliance calculations.

a. A waterworks that uses a surface water source, a GUDI source, or both other than those identified in subdivision A 1 b or A 1 c of this section shall comply with requirements contained in subdivision A 2 b or A 2 c of this section. The owner shall calculate compliance quarterly, beginning after the waterworks has collected 12 months of data, by determining an annual average using the following method:

(1) Determine actual monthly TOC percentage removal, equal to:

[1-(treated water TOC/source water TOC)] X 100.

(2) Determine the required monthly TOC percentage removal (from either Table 411.1 or from subdivision A 2 c of this section).

(3) Divide the value in subdivision A 3 a (1) of this section by the value in subdivision A 3 a (2) of this section.

(4) Add together the results of subdivision A 3 a (3) of this section for the last 12 months and divide by 12.

(5) If the value calculated in subdivision A 3 a (4) of this section is less than 1.00, then the waterworks is not in compliance with the TOC percentage removal requirements.

b. The owner may use the provisions in subdivisions A 3 b (1) through A 3 b (5) of this section instead of the calculations in subdivisions A 3 a (1) through A 3 a (5) of this section to determine compliance with TOC percentage removal requirements.

(1) In any month that the waterworks' treated or source water TOC level is less than 2.0 mg/L, the waterworks may assign a monthly value of 1.0 (instead of the value calculated in subdivision A 3 a (3) of this section) when calculating compliance under the provisions of subdivision A 3 a of this section.

(2) In any month that a waterworks practicing softening removes at least 10 mg/L of magnesium hardness (as CaCO3), the waterworks may assign a monthly value of 1.0 (instead of the value calculated in subdivision A 3 a (3) of this section) when calculating compliance under the provisions of subdivision A 3 a of this section.

(3) In any month that the waterworks source water SUVA before any treatment is equal to or less than 2.0 L/mg-m, the waterworks may assign a monthly value of 1.0 (instead of the value calculated in subdivision A 3 a (3) of this section) when calculating compliance under the provisions of subdivision A 3 a of this section.

(4) In any month that the waterworks finished water SUVA is equal to or less than 2.0 L/mg-m, the waterworks may assign a monthly value of 1.0 (instead of the value calculated in subdivision A 3 a (3) of this section) when calculating compliance under the provisions of subdivision A 3 a of this section.

(5) In any month that the waterworks practicing enhanced softening lowers the alkalinity below 60 mg/L (as CaCO₃), the waterworks may assign a monthly value of 1.0 (instead of the value calculated in subdivision A 3 a (3) of this section) when calculating compliance under the provisions of subdivision A 3 a of this section.

c. A waterworks that uses a surface water source, a GUDI source, or both and uses conventional treatment may also comply with the requirements of this section by meeting the criteria in subdivision A 1 b or A 1 c of this section.

4. Enhanced coagulation or enhanced softening is the treatment technique required to control the level of DBP precursors in water treatment and distribution system for a waterworks using a surface water source, a GUDI source, or both and using conventional treatment.

B. The BAT, treatment techniques, or other means available for achieving compliance with the PMCLs for DBPs shown in Table 340.6 are listed in this subsection:

1. The BAT, treatment techniques, or other means available for achieving compliance with the PMCLs for bromate and chlorite:

| | DISINFECTION BYPRODUCT | BEST AVAILABLE TECHNOLOGY | | --- | --- | --- | | | Bromate | Control of ozone treatment process to reduce production of bromate | | | Chlorite | Control of treatment processes to reduce disinfectant demand and control of disinfection treatment processes to reduce disinfectant levels |

2. The BAT, treatment techniques, or other means available for achieving compliance with the RAA PMCLs for TTHM and HAA5:

| | DISINFECTION BYPRODUCT | BEST AVAILABLE TECHNOLOGY | | --- | --- | --- | | | TTHM and HAA5 | Enhanced coagulation or enhanced softening or GAC10, with chlorine as the primary and residual disinfectant |

3. The BAT, treatment techniques, or other means available for achieving compliance with the LRAA PMCLs for TTHM and HAA5 for a waterworks that disinfects its source water:

| | DISINFECTION BYPRODUCT | BEST AVAILABLE TECHNOLOGY | | --- | --- | --- | | | TTHM and HAA5 | Enhanced coagulation or enhanced softening, plus GAC10; or NF with a molecular weight cutoff fewer than or equal to 1,000 Daltons; or GAC20 |

4. The BAT, treatment techniques, or other means available for achieving compliance with the LRAA MCLs for TTHM and HAA5 for a a consecutive waterworks and applies only to the disinfected water that a consecutive waterworks buys or otherwise receives:

| | DISINFECTION BYPRODUCT | BEST AVAILABLE TECHNOLOGY | | --- | --- | --- | | | TTHM and HAA5 | A waterworks serving equal to or greater than 10,000 people: Improved distribution system and storage tank management to reduce residence time, plus the use of chloramines for residual disinfectant maintenance A waterworks serving fewer than 10,000 people: Improved distribution system and storage tank management to reduce residence time |

C. The BAT, treatment techniques, or other means available for achieving compliance with the MRDLs identified in Table 340.7 are the controls of treatment processes to reduce disinfectant demand and controls of disinfection treatment processes to reduce disinfectant levels.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-415 Uncovered finished water storage

A. A waterworks with uncovered finished water storage facilities shall comply with the requirements to cover the facility as described in this section.

B. The owner shall immediately notify the department of the use of each uncovered finished water storage facility.

C. All uncovered finished water storage facilities shall be covered in compliance with a schedule approved by the department.

D. Failure to comply with the requirements of this section is a violation of the treatment technique requirement.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-420 (Repealed.)

History

• Historical Notes: Derived from VR355-18-004.09 § 2.9, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 12, Issue 2, eff. November, 15, 1995; Volume 18, Issue 19, eff. July 3, 2002; Volume 19, Issue 17, eff. June 4, 2003; Volume 19, Issue 20, eff. July 16, 2003; Volume 21, Issue 13, eff. April 6, 2005; Volume 25, Issue 5, eff. December 10, 2008; Volume 27, Issue 1, eff. October 13, 2010; Volume 28, Issue 5, eff. December 7, 2011; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-421 Groundwater system treatment techniques

A. The owner of a groundwater system that (i) has a confirmed E. coli contamination as described in 12VAC5-590-379 B or (ii) has been notified in writing of a significant deficiency as described in 12VAC5-590-350 D shall meet the requirements of this section. Failure to meet any requirement of this section after the applicable time period specified is a treatment technique violation.

1. The owner shall implement one or more of the following corrective actions:

a. Correct all significant deficiencies;

b. Provide an alternate source of water;

c. Eliminate the source of contamination; or

d. Provide treatment of the groundwater source that reliably achieves at least 4-log treatment of viruses before or at the first customer.

2. Unless the department directs the owner to implement a specific corrective action, the owner shall consult with the department regarding the appropriate corrective action within 30 days of receiving written notification from the department or the laboratory. This consultation may take the form of a telephone conversation, email, meeting, or other mechanism agreed to by the department.

3. Within 45 days of receiving this notification, the owner shall submit a written corrective action plan (CAP) to the department that satisfactorily addresses the deficiency. The CAP shall include a schedule for completing individual actions, and it shall include one or more of the corrective actions in subdivision A 1 of this section. Approval of the CAP by the department constitutes an approved CAP.

4. Within 120 days of receiving written notification from the department or the laboratory, the owner shall either:

a. Have completed corrective actions in accordance with the department approved CAP including department specified interim measures; or

b. Be in compliance with a department approved CAP and schedule.

(1) Any subsequent modifications to a department approved CAP and schedule shall also be approved by the department.

(2) If the department specifies interim measures for protection of the public health pending the department's approval of the CAP and schedule or pending completion of the CAP, then the owner shall comply with these interim measures as well as with any schedule specified by the department.

5. When a significant deficiency is identified at awaterworksthat uses both a groundwater and a surface water or a GUDI source, the owner shall comply withthis sectionunless the department has determined that the significant deficiency is in a portion of the distribution system that is served solely by the surface water or the GUDI source .

B. The owner of a groundwater system that provides at least 4-log treatment of viruses before or at the first customer shall conduct compliance monitoring to demonstrate treatment effectiveness in accordance with subsection C of this section. The owner shall also conduct source water monitoring in accordance with 12VAC5-590-379 C.

The owner shall provide engineering, operational, or other information as required by the department to complete a determination of virus treatment effectiveness.

C. The owner of a groundwater system that provides at least 4-log treatment of viruses shall monitor the effectiveness and reliability of treatment for that groundwater source before or at the first customer as follows:

1. Chemical disinfection.

a. The owner of a groundwater system that serves greater than 3,300 people shall continuously monitor and record the residual disinfectant concentration using analytical methods specified in 12VAC5-590-440 at a location approved by the department and shall record the lowest residual disinfectant concentration each day that water from the groundwater source is served to the public. The owner shall maintain at least the department-determined residual disinfectant concentration every day the groundwater system serves water from the groundwater source to the public. If there is a failure in the continuous monitoring equipment, the owner shall conduct grab sampling every four hours until the continuous monitoring equipment is returned to service. The system shall resume continuous residual disinfectant monitoring within 14 days.

b. The owner of a groundwater system that serves 3,300 or fewer people shall monitor the residual disinfectant concentration using analytical methods specified in 12VAC5-590-440 at a location approved by the department and record the residual disinfection concentration each day that water from the groundwater source is served to the public. The owner shall maintain the department-determined residual disinfectant concentration every day the groundwater system serves water from the groundwater source to the public. The owner shall collect a daily grab sample during the hour of peak flow or at another time specified by the department. If any daily grab sample measurement falls below the department-determined residual disinfectant concentration, the owner shall collect follow-up samples every four hours until the residual disinfectant concentration is restored to the department-determined level. The owner of a groundwater system that serves 3,300 or fewer people may monitor continuously to meet the requirements of this subsection.

c. When the disinfection treatment is required based on confirmed E. colicontamination in the source water, the requirements in this section apply. When the disinfection treatment is required for any other reason or provided voluntarily by the owner, the department will determine the frequency of residual disinfectant monitoring.

d. Failure to maintain the department-specified minimum residual disinfectant concentration for a period of more than four hours is a violation of the treatment technique requirement.

2. The owner of a groundwater system that uses a department-approved alternative treatment to meet the requirements of this section by providing at least 4-log treatment of viruses before or at the first customer shall:

a. Monitor the alternative treatment in accordance with all department-specified monitoring requirements; and

b. Operate the alternative treatment in accordance with all department-specified compliance requirements necessary to achieve at least 4-log treatment of viruses.

3. Failure to meet the monitoring requirements of subsection C of this section is a violation and requires the owner to provide public notification as required in 12VAC5-590-540 A 3.

D. Discontinuing compliance monitoring or treatment.

1. The owner may discontinue compliance monitoring if the department determines and documents in writing that compliance monitoring is no longer necessary for that groundwater source. The owner of a groundwater systems that has department approval to discontinue compliance monitoring shall be subject to the triggered source water monitoring requirements of 12VAC5-590-379 B 1.

2. The owner of a groundwater system that is discontinuing compliance monitoring is still subject to the requirements of 12VAC5-590-380 G.

3. The owner that has been required by the department to provide at least 4-log treatment of viruses shall not discontinue treatment or monitoring.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011; amended, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-425 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-430 Determination of surface water influence of groundwater sources

A. A groundwater source utilized by a waterworks, including wells, springs, and infiltration galleries, shall be evaluated by the department and a determination of surface water influence shall be made by the department. The owner shall provide to the department all necessary information to make this determination in accordance with the three-step procedure described in subsection B of this section.

B. The groundwater source shall be evaluated and subjected to the criteria in a stepwise fashion. Once the department has made a determination with regard to surface water influence, it is not necessary to continue to the next step:

1. Step 1. Evaluation of source history, construction, and location.

a. The source is under the direct influence of surface water if it has been directly associated with a biological waterborne disease outbreak.

b. The source is under the direct influence of surface water if there are any demonstrated or known direct connections between the source to surface water via surface water bodies, sinkholes, troughs, drainage ways, or other geologic features.

c. The source is under the direct influence of surface water if a sanitary survey reveals, or there is other evidence to indicate, that surface water is directly entering the source.

d. If the department has not determined that the source is influenced by surface water based upon the criteria in subdivisions B 1 a, B 1 b, and B 1 c of this section, then the source evaluation proceeds to Step 2.

2. Step 2. Microbiological water quality.

a. The owner shall collect a series of bacteriological samples directly from the source before any treatment. The specific number of samples to be collected, the sampling frequency, and the duration of sampling shall be determined by the department.

(1) At a minimum, a series of 20 samples collected on a weekly frequency is required. Sample collection may be adjusted within the week to collect samples immediately following rainfall events, whenever possible.

(2) All bacteriological analyses shall be performed by laboratories that have received certification by EPA or DCLS as specified in 12VAC5-590-440 for drinking water samples and by a test method that will yield both total coliform concentration and E. coli concentration.

(3) The department may utilize bacteriological results from source water samples collected in accordance with 12VAC5-590-379 C if the sample results cover at least a 20-week period that includes multiple significant rainfall events for this Step 2 evaluation.

b. The total coliform concentration sample results shall be evaluated as follows:

(1) If the results of the total coliform concentration samples indicate three or more samples with total coliform greater than 100 colonies/100 ml, then the source evaluation proceeds to Step 3.

(2) If the results of the total coliform concentration samples indicate a geometric mean equal to or greater than 100 colonies/100 ml, then the requirements of 12VAC5-590-380 G 2 will apply.

c. The E. coli concentration samples shall be evaluated as follows:

(1) If the results of the E. coli concentration samples indicate greater than or equal to five E. coli per 100 ml in three or more samples, then the source evaluation proceeds to Step 3.

(2) If the results of the E. coli concentration samples indicate the presence of E. coli in five or more samples, then the source evaluation proceeds to Step 3.

3. Step 3. Additional water quality monitoring.

a. The owner shall prepare and submit a written source water monitoring plan to the department for approval detailing additional water quality samples to be collected directly from the source before any treatment and if applicable from a nearby surface water source. The monitoring plan shall include the following:

(1) The specific parameters to be monitored.

(2) The monitoring frequency for each parameter.

(3) The duration of monitoring.

b. The source water monitoring plan shall include microscopic particulate analysis (MPA).

(1) A minimum of four source water MPA tests is required, two to be conducted during a wet period and two to be conducted during a dry period. All MPA tests shall be collected at least 60 days apart.

(2) All MPA tests shall be performed by a laboratory approved by the department and shall include both Giardia lamblia and Cryptosporidium.

(3) All MPA testing and reporting of results shall be in accordance with EPA "Consensus Method for Determining Groundwaters Under the Direct Influence of Surface Water Using Microscopic Particulate Analysis (MPA)," dated October 1992, Environmental Services Division.

c. The source water monitoring plan shall include monitoring of the physical parameters such as temperature, pH, turbidity, conductivity, and other parameters.

(1) If a surface water source is located near the groundwater source being evaluated, then monitoring of the nearby surface water source is required using the same physical parameters and frequency as the groundwater source.

(2) Records of rainfall and other climatological events shall be maintained and reported with the physical parameter results.

d. The owner shall provide the department with all of the monitoring results required in the approved monitoring plan. Results of all MPA tests shall be reported within 10 days of receipt by the owner. If any MPA result indicates the presence of Giardia lamblia or Cryptosporidium, then the owner shall notify the department within 24 hours of receipt. The results of the physical parameter monitoring shall be provided along with applicable rainfall or climatological data to the department in a summary report.

e. The additional water quality monitoring results shall be evaluated as follows:

(1) The source is under the direct influence of surface water if any single MPA test result indicates a score of equal to or greater than 20.

(2) The source is under the direct influence of surface water if any two MPA test results indicate a score of equal to or greater than 15.

(3) The source is under the direct influence of surface water if the results of physical parameter monitoring indicate a correlation between fluctuations in the groundwater source in direct response to a rainfall or other climatological event.

(4) The source is under the direct influence of surface water if the results of physical parameter monitoring indicate a direct correlation between the groundwater source being evaluated and the physical parameters of a nearby surface water source.

(5) The source is a groundwater source and is not under the direct influence of surface water if (i) all MPA test results indicate a score of equal to or less than 9, (ii) there are no fluctuations in source water monitored physical parameters in direct response to a rainfall or other climatological event, and (iii) there is no direct correlation in the monitored physical parameters between the groundwater source being evaluated and a nearby surface water source.

f. If the department has not determined that the source is under the direct influence of surface water based upon the criteria in subdivisions B 3 e (1) through B 3 e (4) of this section, and if at least one of the MPA test results indicate a score of greater than 9 but less than 15, then the department shall evaluate all available water quality monitoring data, source construction, location, geology, and any other relevant factors, and to determine that either:

(1) The source is a groundwater source and is not under the direct influence of surface water; or

(2) The source is at risk and requires continued source water monitoring as prescribed by the department.

C. If the source is subject to the requirements of subdivision B 3 of this section, then the owner shall perform the following interim measures until the department has made a final GUDI determination:

1. Provide disinfection treatment to achieve a 4-log inactivation of virus in accordance with 12VAC5-590-421 A 1 d;

2. Conduct compliance monitoring in accordance with 12VAC5-590-421 C 1;

3. If the disinfection treatment required in subdivision C 1 of this section has to be installed, then the owner shall issue a public notice in accordance with 12VAC5-590-540 A 1 advising consumers to boil the water before using it for human consumption. The boil water notice shall remain in effect until the disinfection treatment is installed and in operation; and

4. The department may require that the owner perform additional interim measures if deemed necessary to protect public health.

D. If the total coliform concentration criteria in subdivision B 2 b of this section or the E. coli concentration criteria in subdivision B 2 c of this section are exceeded or if the department has declared the source to be GUDI, then the owner may propose mitigation measures, a plan to correct deficiencies, or both.

1. Any proposed mitigation measures or corrective actions must be detailed in a report submitted to the department for approval. The report shall be prepared by a professional engineer licensed in Virginia, a professional geologist licensed in Virginia, or other licensed professional approved by the department. The report shall include:

a. A description of the proposed mitigation or corrective action activities such as the repair of structural defects, elimination of sources of contamination in proximity to the source, implementation of source water protection measures, or other mitigation or corrective action activities.

b. Specific milestones and milestone completion dates.

c. A follow-up source water monitoring plan to be implemented upon completion of the mitigation measures or of the corrective actions.

2. If the source must remain in operation during the period of time that the mitigation or corrective action activities are implemented and evaluated, then the department may require that the owner implement the interim measures described in 12VAC5-590-395 A 3 or subdivisions C 1 through C 4 of this section.

3. A final summary report detailing the mitigation measures, the corrective actions, or both that are completed; the results of the follow-up monitoring; conclusions; recommendations; and all other supporting data shall be submitted to the department for approval.

a. The final summary report shall be prepared by a professional engineer licensed in Virginia, a professional geologist licensed in Virginia, or other licensed professional approved by the department.

b. Upon evaluation of the final report and supporting data, the department will make a GUDI determination.

E. For any source previously determined to be a groundwater source and not under the direct influence of surface water, the department may:

1. Require that the source be reevaluated in accordance with procedures contained in this section; or

2. Waive any additional reevaluation under this section.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-004.10 § 2.10, eff. June 23, 1993; amended, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-440 Analytical methods

A. All drinking water analyses for compliance purposes shall be performed by analytical methods that are consistent with current EPA regulations found at 40 CFR Part 141 and 40 CFR Part 143. Standards for laboratories seeking certification to perform drinking water analyses are found in the Regulation for the Certification of Laboratories Analyzing Drinking Water (1VAC30-41) and regulations for the Accreditation for Commercial Environmental Laboratories (1VAC30-46) promulgated by the Department of General Services, DCLS.

B. For the purposes of determining compliance, the department will only accept results from samples that have been collected, handled, processed, and documented in accordance with the Regulation for the Certification of Laboratories Analyzing Drinking Water (1VAC30-41) and regulations for the Accreditation for Commercial Environmental Laboratories (1VAC30-46).

C. Testing for alkalinity, calcium, conductivity, residual disinfectant, orthophosphate, pH, silica, temperature, bromide, turbidity, TOC, DOC, SUVA, and UV₂₅₄ for compliance may be performed by any person or party acceptable to the department in accordance with methods specified in 40 CFR Part 141.

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History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-004.11 § 2.11, eff. June 23, 1993; amended, Virginia Register Volume 12, Issue 2, eff. November 15, 1995; Volume 18, Issue 19, eff. July 3, 2002; Volume 19, Issue 17, eff. June 4, 2003; Volume 19, Issue 24, eff. September 10, 2003; Volume 22, Issue 15, eff. May 3, 2006; Volume 22, Issue 24, eff. September 6, 2006; Volume 25, Issue 5, eff. December 10, 2008; Volume 28, Issue 5, eff. December 7, 2011; Volume 33, Issue 3, eff. November 2, 2016; Volume 37, Issue 20, eff. June 23, 2021.

Article 3 Operation of Waterworks [Repealed]

12VAC5-590-450 Facility and personnel management

Waterworks operation comprises the constant oversight and management of the facilities and personnel. Consideration shall be given to such factors as the competency of personnel; water quality, including drinking water standards; water treatment plant maintenance and cleanliness; analytical laboratory control; and the operation and maintenance of the facilities, including water treatment plant equipment, distribution system equipment, and piping. As the complexity of the waterworks increases, so does the expertise and skill required of the operating staff.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-005.01 § 2.12, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-460 (Repealed.)

History

• Historical Notes: Derived from VR355-18-005.02 § 2.13, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 28, Issue 5, eff. December 7, 2011; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-461 Classification of waterworks, operator requirements, and operator attendance

A. Classification of waterworks. All community and NTNC waterworks, including consecutive waterworks, fitting the classification protocol in this subsection shall be designated as classified waterworks. The department retains the discretion to assign the classification of the waterworks or treatment facility either higher or lower. Those community and NTNC waterworks failing to fall within one of the classifications listed in this subsection shall be designated an unclassified waterworks unless specified otherwise by the department. Normally, a TNC waterworks shall not be classified and shall not be required to have an operator unless the department determines that it is necessary to ensure satisfactory operation of the installed treatment. If a waterworks consists of multiple treatment facilities, then these facilities may be individually classified for the purpose of determining the operator requirements.

1. Class 1 means:

a. A waterworks or a water treatment plant serving 50,000 or more persons, or having a water treatment plant capacity of 5.0 MGD or more and employing conventional filtration or chemical coagulation in combination with membrane filtration; or

b. A waterworks designated by the department to be a Class 1 waterworks.

2. Class 2 means:

a. A waterworks or a water treatment plant serving 5,000 or more persons but fewer than 50,000 persons or having a water treatment plant capacity of 0.5 MGD or more but less than 5.0 MGD, whichever range applies, and employing rapid rate conventional filtration (see 12VAC5-590-874) or chemical coagulation in combination with membrane filtration;

b. A waterworks or a water treatment plant serving fewer than 50,000 persons or having a water treatment plant capacity of less than 5.0 MGD and employing high rate conventional filtration (see 12VAC5-590-874); or

c. A waterworks designated by the department to be a Class 2 waterworks.

3. Class 3 means:

a. A waterworks or a water treatment plant serving fewer than 5,000 persons or having a water treatment plant capacity less than 0.5 MGD, whichever is greater, and employing conventional filtration or chemical coagulation in combination with membrane filtration;

b. A waterworks or a water treatment plant serving 5,000 or more persons or having a water treatment plant capacity of 0.5 MGD or more, whichever is greater, and employing one or more of the following: disinfection other than with hypochlorination, caustic soda feed, iron and manganese removal, ion exchange, slow sand filtration, aeration, rechlorination other than with hypochlorination, activated carbon contactors, membrane or other filtration technologies without chemical coagulation, and fluoridation with a saturator or acid feed;

c. A waterworks or a water treatment plant employing fluoridation with other than a saturator not considered a Class 1 or Class 2 waterworks; or

d. A waterworks designated by the department to be a Class 3 waterworks.

4. Class 4 means:

a. A waterworks or a water treatment plant serving fewer than 5,000 persons or having a water treatment plant capacity of less than 0.5 MGD and employing one or more of the following: disinfection other than with hypochlorination, caustic soda feed, iron and manganese removal, ion exchange, slow sand filtration, aeration, rechlorination other than with hypochlorination, activated carbon contactors, membrane or other filtration technologies without chemical coagulation, and fluoridation with a saturator; or

b. A waterworks designated by the department to be a Class 4 waterworks.

5. Class 5 means:

a. A waterworks serving 400 or more persons that:

(1) Provides no treatment; or

(2) Employs one or more of the following treatment processes:

(a) Hypochlorination for disinfection;

(b) Corrosion control with calcite or magnesium oxide contactors or solution feed except with caustic soda; or

(c) Sequestration by solution feed.

b. A waterworks designated by the department to be a Class 5 waterworks.

6. Class 6 means:

a. A waterworks serving fewer than 400 persons that:

(1) Provides no treatment; or

(2) Employs one or more of the following treatment processes:

(a) Hypochlorination for disinfection;

(b) Corrosion control with calcite or magnesium oxide contactors or solution feed except with caustic soda; or

(c) Sequestration by solution feed.

b. A waterworks is designated by the department to be a Class 6 waterworks.

B. Operator requirements. The operation of all waterworks must rest in the hands of qualified staff. The number and qualifications of persons constituting the operating staff at a waterworks depend principally upon the capacity of the waterworks, the number of persons served by the waterworks, and the complexity of the treatment process or processes. If a classified waterworks or water treatment plant is without a required operator, then the owner shall notify the department as soon as practical but no later than 24 hours of such an occurrence.

1. The operator attendance requirements specified in subsection C of this section are a minimum to protect the health of the consumer and safety of the operating staff. The department may increase the required operating attendance when appropriate to protect human health.

2. A classified waterworks shall be operated by an operator having a valid license issued by the Commonwealth of Virginia (18VAC160-30-90) with a classification equal to or higher than the classification of the waterworks or water treatment plant being operated. (See definition of operator in 12VAC5-590-10).

3. Operators are not required at unclassified waterworks.

C. Minimum operator attendance at classified waterworks. For the purpose of this section and 12VAC5-590-570, all classified waterworks or individual water treatment plants shall maintain the minimum operator attendance as follows:

1. Class 1. The waterworks shall have a minimum of two operating staff in attendance whenever the water treatment plant is in operation; at least one of the operating staff must be an operator.

2. Class 2. The waterworks shall have a minimum of one operator in attendance whenever the water treatment plant is in operation.

3. Class 3. The waterworks employing conventional filtration or chemical coagulation in combination with membrane filtration shall have a minimum of one operator in attendance whenever the water treatment plant is in operation. All other treatment facilities may have operator attendance similar to a Class 4 waterworks.

4. Class 4. The waterworks shall be attended by an operator at least three days per week, except that water treatment plants employing membrane filters treating surface water sources or GUDI sources shall be attended by an operator daily. The attendance shall be for sufficient time to perform the necessary operations, monitoring, and maintenance.

5. Class 5 and Class 6.

a. Where no treatment is provided, the waterworks shall be attended by an operator at least twice a month.

b. When treatment is provided, the waterworks shall be attended by an operator at least once per week.

c. The attendance shall be for sufficient time to perform the necessary operations, monitoring, and maintenance.

D. Operator attendance alternatives.

1. Increased staffing attendance may be required by the department on a case-by-case basis to protect public health.

2. Reduced operator attendance for Class 3 through Class 6 waterworks may be considered by the department on a case-by-case basis.

3. When requiring increased operator attendance or considering reduced operator attendance the department will consider the following criteria, including:

a. Operational history;

b. Type of treatment;

c. Facility capacity and hours of operation;

d. Population served;

e. Type and reliability of remote monitoring controls, alarms, and communications;

f. Reliable staff communications; and

g. Emergency response plans and procedures.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-470 Waterworks condition

The waterworks shall be maintained in a clean and orderly condition.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-005.03 § 2.14, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-475 Removal of wells from service

A. Temporary inactivation.

1. A water well temporarily inactivated shall be sealed with a watertight cap or wellhead seal.

2. The well shall be maintained so that it will not be a source or channel for contamination during temporary inactivation.

3. The wellhead shall be visually inspected and observations documented to verify adequate sanitary integrity on a quarterly basis.

4. The well lot shall be maintained.

B. Permanent abandonment.

1. Well abandonment shall be supervised by a certified water well systems provider.

2. All well abandonments shall be documented on a Uniform Water Well Completion Report, Form GW-2, and submitted to the department within 30 days of completing the physical abandonment.

3. Groundwater wells that are abandoned shall be sealed by methods that will restore to the fullest extent possible the controlling geological conditions that existed before the wells were constructed.

4. Casing and screen materials may be salvaged.

5. The well shall be checked from land surface to the entire depth of the well before it is sealed to ascertain freedom from obstructions that may interfere with sealing operations. Effort shall be made to remove or clear any obstacles that may prohibit sealing by grouting the complete well depth.

6. The well shall be thoroughly chlorinated before sealing.

7. Bored wells and uncased wells shall be backfilled with clean fill to the water level. A two-foot-thick bentonite grout plug shall be placed immediately above the water level. Clean fill shall be placed on top of the bentonite grout plug and brought up to at least five feet from the ground surface. The top five feet of the well casing, if present, shall be removed from the bore hole. If an open annular space is present around the well casing, then the annular space shall be filled with bentonite grout to the maximum depth possible, but less than or equal to 20 feet. A one-foot-thick cement or bentonite grout plug that completely fills the bore void space shall be placed a minimum of five feet from the ground surface. As an alternative, bored wells and uncased wells may be completely filled with concrete, sand-cement, bentonite-cement, or neat cement grout to within a minimum of five feet from the ground surface by introduction through a pipe initially extending to the bottom of the well. The pipe shall be raised but remain submerged in grout or concrete as the well is filled. The remaining space shall be filled with clean fill that is mounded a minimum of one foot above the surrounding ground surface.

8. Non-bored wells constructed in unconsolidated formations shall be completely filled with concrete, sand-cement, bentonite-cement, or neat cement grout to within a minimum of five feet from the ground surface by introduction through a pipe initially extending to the bottom of the well. The pipe shall be raised but remain submerged in grout or concrete as the well is filled. The remaining space shall be filled with clean fill that is mounded a minimum of one foot above the surrounding ground surface.

9. Wells constructed in consolidated rock formations or that penetrate zones of consolidated rock may be filled with sand or gravel opposite the zones of consolidated rock. The top of the sand or gravel fill shall be at least five feet below the top of the consolidated rock and at least 20 feet below land surface. The remainder of the well shall be filled with concrete, sand-cement, bentonite-cement, or neat cement grout to within a minimum of five feet from the ground surface by introduction through a pipe initially extending to the bottom of the well. The pipe shall be raised but remain submerged in grout or concrete as the well is filled. The remaining space shall be filled with clean fill that is mounded a minimum of one foot above the surrounding ground surface.

10. The location of the well shall be permanently documented for future reference.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-476 Reactivation of wells

A. The owner shall notify the department of the intent to reactivate a well.

B. Before bringing the well into service, the well shall be pumped to waste (purged) for a minimum of five well volumes but for not less than 30 minutes. The purged well water shall be discharged in a manner so that it will not return to the well, directly or indirectly, during the pumping period.

C. After the well is pumped, water quality samples shall be collected. If the well has been inactive for less than one year, then two samples shall be collected at least 30 minutes apart and tested for the presence of E. coli. If the well has been inactive for one or more years, then it shall be tested for total coliform density (MPN), nitrate, and, if determined by the department, inorganics, VOCs, SOCs, and radionuclides. Satisfactory test results shall be obtained before placing the well in service.

D. A well yield and drawdown test may be required by the department before bringing the well into service. The test shall be performed in accordance with 12VAC5-590-840 H, as applicable.

E. A well may be activated for emergency use before receipt of satisfactory monitoring results, even if public health and safety are unknowns and may be at risk, as determined by the department. However, in these circumstances, a special water advisory shall be approved by the department and issued by the waterworks at the same time the well is activated.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-480 Operational control testing and monitoring

A. Water analyses and tests performed at waterworks are conducted for four main purposes: (i) to ensure compliance; (ii) to control water treatment plant operation; (iii) to record water treatment plant performance; and (iv) to provide information for improving water treatment plant performance. Tests designed to control operation shall present evidence that:

1. Each key process, such as mixing, coagulation, sedimentation, filtration, softening, iron and manganese removal, disinfection, and taste and odor control, is effective; and

2. The finished product is clean, is free from objectionable taste and odor, is free from undesirable chemical characteristics, and is safe for human consumption.

B. Testing for regulatory compliance purposes shall use an EPA-approved analytical method found in 40 CFR Parts 141 and 143. Instruments used for operational control purposes must be calibrated in accordance with manufacturer instructions. Calibrations shall be documented in a manner acceptable to the department.

C. Ample laboratory space shall be provided for all required laboratory analyses as specified in 12VAC5-590-760.

D. Required waterworks onsite laboratory analyses. The analyses listed in this subsection are the minimum required. Additional testing may be required by the department.

1. The owner of a waterworks employing chemical coagulation or lime softening in combination with any filtration treatment for turbidity removal or TOC reduction shall provide equipment for the analysis of pH, alkalinity, hardness, turbidity, water temperature, and coagulant dosage. A calibrated electric pH meter must be provided; however, a color comparator may be used as a backup unit. Turbidities must be determined by the use of a calibrated turbidimeter.

2. The owner of a waterworks employing membrane filtration without chemical coagulation or lime softening shall provide equipment for the analysis of turbidity and temperature. Turbidities shall be determined by the use of a calibrated turbidimeter.

3. The owner of a waterworks employing softening only and utilizing chemical precipitation shall provide equipment for the analysis of pH utilizing a calibrated electric pH meter, alkalinity, hardness, water temperature, and chemical dosage for precipitation utilizing a multiple jar stirring machine.

4. The owner of a waterworks employing iron and manganese removal by chemical precipitation shall provide equipment for the analysis of pH, alkalinity, iron, manganese, and water temperature.

5. The owner of a waterworks employing fluoridation shall provide equipment for the analysis of the fluoride ion concentration and water temperature.

6. The owner of a waterworks employing chlorination, rechlorination, chloramination, or rechloramination shall provide equipment for the analysis of the appropriate chlorine residual measurement and temperature.

7. The owner of a waterworks employing iron and manganese removal by ion exchange or softening by ion exchange shall provide equipment for the analysis of iron and manganese.

E. Process control instruments, monitors, gauges, and controllers, including reading, recording, and alarm features, required in Part III, Manual of Practice (12VAC5-590-640 et seq.), shall be maintained fully operational and calibrated in accordance with the manufacturer instructions.

1. The owner of a waterworks employing UV for inactivation credit shall perform UV sensor calibration checks. Calibrations and instrument checks shall be documented in a manner acceptable to the department. All UV sensors shall be calibrated with a reference UV sensor at least monthly. It is also recommended that offline and standby sensors be calibrated at the same time. At least one reference sensor for calibration of online sensors shall be provided. The reference UV sensor shall be calibrated at least yearly at a qualified facility, usually the manufacturer. Ultraviolet transmittance (UVT) analyzer calibration is required when used as a control instrument. The UVT analyzer shall be calibrated at least weekly by comparing online measurements to a benchtop spectrophotometer that is calibrated in accordance with manufacturer instructions. Instead of an online UVT analyzer, a benchtop spectrophotometer may be utilized to determine UV transmittance at least every four hours.

2. The owner of a waterworks employing ozone for inactivation credit shall perform calibration checks on continuous, online ozone residual monitors at least weekly. Inactivation credits for a multiple chamber contactor shall be based on only the chambers that have a measured ozone residual greater than 0.02 mg/L or higher, depending on residual analysis instrumentation.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-005.04 § 2.15, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-490 Adequate treatment

A. Adequate treatment is any one or any combination of the controlled processes of coagulation, sedimentation, absorption, filtration, disinfection, or other processes that produce water consistently meeting the requirements of this chapter. The concept of adequate treatment also includes processes that are appropriate to (i) the source water; (ii) waterworks that are of adequate capacity to meet maximum demands without creating health hazards and that are located, designed, and constructed to eliminate or prevent cross-connections; and (iii) the conscientious operation by well-trained and competent personnel whose qualifications are commensurate with the responsibilities of the position and acceptable to the department.

B. A waterworks shall provide adequate treatment when required and in accordance with 12VAC5-590-680 to ensure the production of potable water.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-005.05 § 2.16, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-500 Disinfection criteria, determination of CT, disinfection profiles, and disinfection benchmarks for Giardia and virus inactivation

A. A waterworks utilizing surface water sources or GUDI sources, in whole or in part, shall be disinfected in accordance with subsection C of this section and 12VAC5-590-1000.

B. The owner of a groundwater system subject to the requirements of 12VAC5-590-421 A 1 d shall provide primary disinfection treatment by means of one of the following:

1. A residual disinfectant concentration (C) and contact time (T) to achieve a 4-log removal or inactivation of viruses. CT shall be calculated in accordance with subsections C and D of this section, which contain information on calculation methods and contact tank baffling factors.

2. UV treatment to achieve a 4-log removal or inactivation of viruses. Log inactivation shall be determined in accordance with 12VAC5-590-401 E 7 c. A secondary disinfection residual in the distribution system may be required by the department.

C. Disinfection criteria.

1. An owner of a waterworks utilizing surface water sources, in whole or in part, or GUDI sources shall provide a minimum 3-log (99.9%) removal of Giardia cysts and a 4-log (99.99%) removal of viruses, respectively.

2. Additional inactivation levels that must be achieved by disinfection shall be in accordance with Table 500.1 for waterworks employing the filtration processes listed.

| TABLE 500.1 Maximum Log Removal Credits for Various Filtration Technologies and the Resulting Minimum Required Logs of Inactivation by Disinfection | | | | | | --- | --- | --- | --- | --- | | FILTRATION PROCESS^a | MAXIMUM LOG REMOVAL CREDITS FOR FILTRATION | ADDITIONAL LOG INACTIVATION REQUIRED BY DISINFECTION | | | | Giardia lamblia | Viruses | Giardia lamblia | Viruses | | | Conventional | 2.5 | 2.0 | 0.5 | 2.0 | | Direct | 2.0 | 1.0 | 1.0 | 3.0 | | Pre-engineered package | 2.5 | Zero | 0.5 | 4.0 | | Diatomaceous Earth | 2.0 | 1.0 | 1.0 | 3.0 | | Slow Sand | 2.0 | 2.0 | 1.0 | 2.0 | | Membrane (MF or UF) | 3.0 | Zero | 0.5 | 4.0 | | Bag or Cartridge | 2.0 | Zero | 1.0 | 4.0 | | ^aRefer to Part III of this chapter for further description of the filtration processes. | | | | |

D. A disinfection profile shall be developed in accordance with the procedures in subdivisions D 1, D 2, and D 3.

1. The owner shall monitor at least weekly for a period of 12 consecutive months to determine the total log inactivation for Giardia lamblia and viruses. If an owner monitors more frequently, then the monitoring frequency shall be evenly spaced. An owner of a waterworks that operates for fewer than 12 months per year shall monitor weekly during the period of operation.

2. The owner of a waterworks with a single point of disinfectant application before the entrance to the distribution system or with more than one point of disinfectant application shall conduct the monitoring in subdivisions D 2 a through D 2 e of this section.

a. For a waterworks using a disinfectant other than UV, the temperature of the disinfected water shall be measured at each residual disinfectant concentration sampling point during peak hourly flow or at an alternative location approved by the department.

b. For a waterworks using chlorine, the pH of the disinfected water shall be measured at each chlorine residual disinfectant concentration sampling point during peak hourly flow or at an alternative location approved by the department.

c. The residual disinfectant concentration (C) of the water before or at the first customer and before each additional point of disinfectant application shall be measured at peak hourly flow.

d. The disinfectant contact times (T) of the water before or at the first customer and before each additional point of disinfectant application shall be determined during peak hourly flow. The disinfectant contact time to be used for calculating CT is T₁₀, which is the detention time at which 90% of the water passing through a unit is retained within that unit. T₁₀ shall be determined either by calculations that involve the theoretical hydraulic detention time and baffling factors that account for the degree of short-circuiting that might be expected through any given unit or by tracer studies. The baffling factors listed in Table 500.15 shall be used in determining contact time if tracer studies are not performed.

e. Inactivation credits for ozone contactors will be based on only the chambers that have a measured ozone residual. A minimum of two dedicated online monitors per ozone contactor shall be installed at locations suited to the CT calculation method used. Ozone residual levels shall be monitored continuously and recorded. Methods for computing log inactivation of Giardia lamblia and virus shall be approved by the department. Tracer studies shall be required to verify T₁₀ values before receiving inactivation credit.

3. Instead of conducting new monitoring under subdivision D 2 of this section, an owner may elect to meet the requirements of subdivision D 3 a or D 3 b of this section.

a. The owner who has at least one year of existing data that are substantially equivalent to data collected under the provisions of subdivision D 3 of this section shall use these data to develop disinfection profiles if the owner has neither made a significant change to the treatment practice nor changed sources since the data were collected. The owner may develop a disinfection profile using up to three years of existing data.

b. The owner may use a disinfection profile developed previously in accordance with the procedures in subdivisions D 1, D 2, and D 3 of this section, if the owner has neither made a change to the treatment practice nor changed sources since the profile was developed. An owner that has not developed a virus profile shall develop a virus disinfection profile using the same monitoring data on which the Giardia lamblia profile is based.

E. The owner shall calculate the total inactivation ratio for Giardia lamblia and viruses as specified in subdivisions E 1 through E 4 of this subsection based on CT_99.9(3-log)values using the appropriate values in Tables 500.2 through 500.14. Note that the 3-log values in the tables for Giardia lamblia also indicate that a 4-log virus inactivation can be achieved. pH and temperature values between the indicated values in Tables 500.2 through 500.14 shall be determined by linear interpolation, or the CT value at the lower temperature and at the higher pH shall be used. All parameters necessary to determine the total inactivation ratio shall be monitored during peak hourly flow.

1. The owner using only one point of disinfectant application shall determine the total inactivation ratio for the disinfection segment based on either of the following methods:

a. Determine one inactivation ratio (CT_calc/CT_99.9) before or at the first customer during peak hourly flow.

b. Determine successive CT_calc/CT_99.9values, representing sequential inactivation ratios, between the point of disinfectant application and a point before or at the first customer during peak hourly flow. The owner shall calculate the total inactivation ratio by determining (CT_calc/CT_99.9) for each sequence and then adding the (CT_calc/CT_99.9) values together to determine total inactivation (∑ (CT_calc/CT_99.9)).

2. The owner using more than one point of disinfectant application before the first customer shall determine the CT value of each disinfection segment immediately before the next point of disinfectant application, or for the final segment before or at the first customer, during peak hourly flow. The (CT_calc/CT_99.9) value of each segment and (∑ (CT_calc/CT_99.9)) shall be calculated using the method in subdivision E 1 a or E 1 b of this subsection.

3. The owner shall determine the total logs of inactivation of Giardia lamblia by multiplying the value calculated in subdivision E 1 a or E 1 b of this subsection by 3.0.

4. The owner shall determine the total logs of inactivation of viruses by multiplying the value calculated in subdivision E 1 a or E 1 b of this subsection by 4.0.

F. A disinfection benchmark shall be calculated following the procedures in subdivisions F 1, F 2, and F 3 of this subsection.

1. For each year of profiling data collected and calculated, an owner shall determine the lowest mean monthly level of both Giardia lamblia and virus inactivation. The owner shall determine the mean Giardia lamblia and virus inactivation for each calendar month for each year of profiling data by dividing the sum of daily or weekly Giardia lamblia and virus log inactivation by the number of values calculated for that month.

2. The disinfection benchmark is the lowest monthly mean value (for waterworks with one year of profiling data) or the mean of the lowest monthly mean values (for waterworks with more than one year of profiling data) of Giardia lamblia and virus log inactivation in each year of profiling data.

3. The owner of a waterworks using chloramines, ozone, or chlorine dioxide for primary disinfection shall calculate the disinfection benchmark for viruses from the data collected in the same manner used to calculate the Giardia lamblia disinfection benchmark.

G. The owner shall retain the disinfection profile in graphic form, as a spreadsheet or in some other format acceptable to the department for evaluation as part of sanitary surveys conducted by the department.

H. Before making a significant change to the waterworks disinfection practice, the owner shall review the disinfection benchmark and consult with the department.

1. Significant changes to disinfection practice are (i) changes to the point of disinfectant application, (ii) changes to the disinfectants used in the treatment plant, (iii) changes to the disinfection process, and (iv) any other modification identified by the department.

2. The owner shall submit the following information to the department as part of the consultation process: (i) a description of the proposed change; (ii) the disinfection profile and benchmarks established for Giardia lamblia and, if necessary, viruses; (iii) an analysis of how the proposed change will affect the current levels of disinfection; and (iv) any additional information to justify the change.

| TABLE 500.2 CT Values for 3-Log Inactivation of Giardia lamblia by Free Chlorine at Less than 0.5^oC | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | FREE RESIDUAL (mg/L) | pH | | | | | | | | ≤ 6.0 | 6.5 | 7.0 | 7.5 | 8.0 | 8.5 | ≤ 9.0 | | | ≤ 0.4 | 137 | 163 | 195 | 237 | 277 | 329 | 390 | | 0.6 | 141 | 168 | 200 | 239 | 286 | 342 | 407 | | 0.8 | 145 | 172 | 205 | 246 | 295 | 354 | 422 | | 1.0 | 148 | 176 | 210 | 253 | 304 | 365 | 437 | | 1.2 | 152 | 180 | 215 | 259 | 313 | 376 | 451 | | 1.4 | 155 | 184 | 221 | 266 | 321 | 387 | 464 | | 1.6 | 157 | 189 | 226 | 273 | 329 | 397 | 477 | | 1.8 | 162 | 193 | 231 | 279 | 338 | 407 | 489 | | 2.0 | 165 | 197 | 236 | 286 | 346 | 417 | 500 | | 2.2 | 169 | 201 | 242 | 297 | 353 | 426 | 511 | | 2.4 | 172 | 205 | 247 | 298 | 361 | 435 | 522 | | 2.6 | 175 | 209 | 252 | 304 | 368 | 444 | 533 | | 2.8 | 178 | 213 | 257 | 310 | 375 | 452 | 543 | | 3.0 | 181 | 217 | 261 | 316 | 382 | 460 | 552 |

| TABLE 500.3 CT Values for 3-Log Inactivation of Giardia lamblia by Free Chlorine at 5^oC | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | FREE RESIDUAL (mg/L) | pH | | | | | | | | ≤ 6.0 | 6.5 | 7.0 | 7.5 | 8.0 | 8.5 | ≤ 9.0 | | | ≤ 0.4 | 97 | 117 | 139 | 166 | 198 | 236 | 279 | | 0.6 | 100 | 120 | 143 | 171 | 204 | 244 | 291 | | 0.8 | 103 | 122 | 146 | 175 | 210 | 252 | 301 | | 1.0 | 105 | 125 | 149 | 179 | 216 | 260 | 312 | | 1.2 | 107 | 127 | 152 | 183 | 221 | 267 | 320 | | 1.4 | 109 | 130 | 155 | 187 | 227 | 274 | 329 | | 1.6 | 111 | 132 | 158 | 192 | 232 | 281 | 337 | | 1.8 | 114 | 135 | 162 | 196 | 238 | 287 | 345 | | 2.0 | 116 | 138 | 165 | 200 | 243 | 294 | 353 | | 2.2 | 118 | 140 | 169 | 204 | 248 | 300 | 361 | | 2.4 | 120 | 143 | 172 | 209 | 253 | 306 | 368 | | 2.6 | 122 | 146 | 175 | 213 | 258 | 312 | 375 | | 2.8 | 124 | 148 | 178 | 217 | 263 | 318 | 382 | | 3.0 | 126 | 151 | 182 | 221 | 268 | 324 | 389 |

| TABLE 500.4 CT Values for 3-Log Inactivation of Giardia lamblia by Free Chlorine at 10^oC | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | FREE RESIDUAL (mg/L) | pH | | | | | | | | ≤ 6.0 | 6.5 | 7.0 | 7.5 | 8.0 | 8.5 | ≤ 9.0 | | | ≤ 0.4 | 73 | 88 | 104 | 125 | 149 | 177 | 209 | | 0.6 | 75 | 90 | 107 | 128 | 153 | 183 | 218 | | 0.8 | 78 | 92 | 110 | 131 | 158 | 189 | 226 | | 1.0 | 79 | 94 | 112 | 134 | 162 | 195 | 234 | | 1.2 | 80 | 95 | 114 | 137 | 166 | 200 | 240 | | 1.4 | 82 | 98 | 116 | 140 | 170 | 206 | 247 | | 1.6 | 83 | 99 | 119 | 144 | 174 | 211 | 253 | | 1.8 | 86 | 101 | 122 | 147 | 179 | 215 | 259 | | 2.0 | 87 | 104 | 124 | 150 | 182 | 221 | 265 | | 2.2 | 89 | 105 | 127 | 153 | 186 | 225 | 271 | | 2.4 | 90 | 107 | 129 | 157 | 190 | 230 | 276 | | 2.6 | 92 | 110 | 131 | 160 | 194 | 234 | 281 | | 2.8 | 93 | 111 | 134 | 163 | 197 | 239 | 287 | | 3.0 | 95 | 113 | 137 | 166 | 201 | 243 | 292 |

| TABLE 500.5 CT Values for 3-Log Inactivation of Giardia lamblia by Free Chlorine at 15^oC | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | FREE RESIDUAL (mg/L) | pH | | | | | | | | ≤ 6.0 | 6.5 | 7.0 | 7.5 | 8.0 | 8.5 | ≤ 9.0 | | | ≤ 0.4 | 49 | 59 | 70 | 83 | 99 | 118 | 140 | | 0.6 | 50 | 60 | 72 | 86 | 102 | 122 | 146 | | 0.8 | 52 | 61 | 73 | 88 | 105 | 126 | 151 | | 1.0 | 53 | 63 | 75 | 90 | 108 | 130 | 156 | | 1.2 | 54 | 64 | 76 | 92 | 111 | 134 | 160 | | 1.4 | 55 | 65 | 78 | 94 | 114 | 137 | 165 | | 1.6 | 56 | 66 | 79 | 96 | 116 | 141 | 169 | | 1.8 | 57 | 68 | 81 | 98 | 119 | 144 | 173 | | 2.0 | 58 | 69 | 83 | 100 | 122 | 147 | 177 | | 2.2 | 59 | 70 | 85 | 102 | 124 | 150 | 181 | | 2.4 | 60 | 72 | 86 | 105 | 127 | 153 | 184 | | 2.6 | 61 | 73 | 88 | 107 | 129 | 156 | 188 | | 2.8 | 62 | 74 | 89 | 109 | 132 | 159 | 191 | | 3.0 | 63 | 76 | 91 | 111 | 134 | 162 | 195 |

| TABLE 500.6 CT Values for 3-Log Inactivation of Giardia lamblia by Free Chlorine at 20^oC | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | FREE RESIDUAL (mg/L) | pH | | | | | | | | ≤ 6.0 | 6.5 | 7.0 | 7.5 | 8.0 | 8.5 | ≤ 9.0 | | | ≤ 0.4 | 36 | 44 | 52 | 62 | 74 | 89 | 105 | | 0.6 | 38 | 45 | 54 | 64 | 77 | 92 | 109 | | 0.8 | 39 | 46 | 55 | 66 | 79 | 95 | 113 | | 1.0 | 39 | 47 | 56 | 67 | 81 | 98 | 117 | | 1.2 | 40 | 48 | 57 | 69 | 83 | 100 | 120 | | 1.4 | 41 | 49 | 58 | 70 | 85 | 103 | 123 | | 1.6 | 42 | 50 | 59 | 72 | 87 | 105 | 126 | | 1.8 | 43 | 51 | 61 | 74 | 89 | 108 | 129 | | 2.0 | 44 | 52 | 62 | 75 | 91 | 110 | 132 | | 2.2 | 44 | 53 | 63 | 77 | 93 | 113 | 135 | | 2.4 | 45 | 54 | 65 | 78 | 95 | 115 | 138 | | 2.6 | 46 | 55 | 66 | 80 | 97 | 117 | 141 | | 2.8 | 47 | 56 | 67 | 81 | 99 | 119 | 143 | | 3.0 | 47 | 57 | 68 | 83 | 101 | 122 | 146 |

| TABLE 500.7 CT Values for 3-Log Inactivation of Giardia lamblia by Free Chlorine at 25oC and Higher | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | FREE RESIDUAL (mg/L) | pH | | | | | | | | ≤ 6.0 | 6.5 | 7.0 | 7.5 | 8.0 | 8.5 | ≤ 9.0 | | | ≤ 0.4 | 24 | 29 | 35 | 42 | 50 | 59 | 70 | | 0.6 | 25 | 30 | 36 | 43 | 51 | 61 | 73 | | 0.8 | 26 | 31 | 37 | 44 | 53 | 63 | 75 | | 1.0 | 26 | 31 | 37 | 45 | 54 | 65 | 78 | | 1.2 | 27 | 32 | 38 | 46 | 55 | 67 | 80 | | 1.4 | 27 | 33 | 39 | 47 | 57 | 69 | 82 | | 1.6 | 28 | 33 | 40 | 48 | 58 | 70 | 84 | | 1.8 | 29 | 34 | 41 | 49 | 60 | 72 | 86 | | 2.0 | 29 | 35 | 41 | 50 | 61 | 74 | 88 | | 2.2 | 30 | 35 | 42 | 51 | 62 | 75 | 90 | | 2.4 | 30 | 36 | 43 | 52 | 63 | 77 | 92 | | 2.6 | 31 | 37 | 44 | 53 | 65 | 78 | 94 | | 2.8 | 31 | 37 | 45 | 54 | 66 | 80 | 96 | | 3.0 | 32 | 38 | 46 | 55 | 67 | 81 | 97 |

| TABLE 500.8 CT Values for Inactivation of Viruses by Free Chlorine, pH 6.0-9.0 | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | LOG INACTIVATION CREDIT | WATER TEMPERATURE (°C) | | | | | | | | | | 0.5 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | | | 2 | 6.0 | 5.8 | 5.3 | 4.9 | 4.4 | 4.0 | 3.8 | 3.6 | 3.4 | | 3 | 9.0 | 8.7 | 8.0 | 7.3 | 6.7 | 6.0 | 5.6 | 5.2 | 4.8 | | 4 | 12.0 | 11.6 | 10.7 | 9.8 | 8.9 | 8.0 | 7.6 | 7.2 | 6.8 | | LOG INACTIVATION CREDIT | WATER TEMPERATURE (°C) | | | | | | | | | | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | | | 2 | 3.2 | 3.0 | 2.8 | 2.6 | 2.4 | 2.2 | 2.0 | 1.8 | 1.6 | | 3 | 4.4 | 4.0 | 3.8 | 3.6 | 3.4 | 3.2 | 3.0 | 2.8 | 2.6 | | 4 | 6.4 | 6.0 | 5.6 | 5.2 | 4.8 | 4.4 | 4.0 | 3.8 | 3.6 | | LOG INACTIVATION CREDIT | WATER TEMPERATURE (°C) | | | | | | | | | | 18 | 19 | 20 | 21 | 22 | 23 | 24 | 25 | | | | 2 | 1.4 | 1.2 | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | | | 3 | 2.4 | 2.2 | 2.0 | 1.8 | 1.6 | 1.4 | 1.2 | 1.0 | | | 4 | 3.4 | 3.2 | 3.0 | 2.8 | 2.6 | 2.4 | 2.2 | 2.0 | |

| TABLE 500.9 CT Values for Inactivation of Giardia lamblia by Chlorine Dioxide, pH 6.0-9.0 | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | LOG INACTIVATION CREDIT | WATER TEMPERATURE (°C) | | | | | | | | | | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | | | 0.5 | 10.0 | 8.6 | 7.2 | 5.7 | 4.3 | 4.2 | 4.2 | 4.1 | 4.1 | | 1 | 21.0 | 17.9 | 14.9 | 11.8 | 8.7 | 8.5 | 8.3 | 8.1 | 7.9 | | 1.5 | 32.0 | 27.3 | 22.5 | 17.8 | 13.0 | 12.8 | 12.6 | 12.4 | 12.2 | | 2 | 42.0 | 35.8 | 29.5 | 23.3 | 17.0 | 16.6 | 16.2 | 15.8 | 15.4 | | 2.5 | 52.0 | 44.5 | 37.0 | 29.5 | 22.0 | 21.4 | 20.8 | 20.2 | 19.6 | | 3 | 63.0 | 53.8 | 44.5 | 35.3 | 26.0 | 25.4 | 24.8 | 24.2 | 23.6 | | LOG INACTIVATION CREDIT | WATER TEMPERATURE (°C) | | | | | | | | | | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | | | 0.5 | 4.0 | 3.8 | 3.7 | 3.5 | 3.4 | 3.2 | 3.1 | 2.9 | 2.8 | | 1 | 7.7 | 7.4 | 7.1 | 6.9 | 6.6 | 6.3 | 6.0 | 5.8 | 5.5 | | 1.5 | 12.0 | 11.6 | 11.2 | 10.8 | 10.4 | 10.0 | 9.5 | 9.0 | 8.5 | | 2 | 15.0 | 14.6 | 14.2 | 13.8 | 13.4 | 13.0 | 12.4 | 11.8 | 11.2 | | 2.5 | 19.0 | 3.8 | 3.7 | 3.5 | 3.4 | 3.2 | 3.1 | 2.9 | 2.8 | | 3 | 23.0 | 7.4 | 7.1 | 6.9 | 6.6 | 6.3 | 6.0 | 5.8 | 5.5 | | LOG INACTIVATION CREDIT | WATER TEMPERATURE (°C) | | | | | | | | | | 19 | 20 | 21 | 22 | 23 | 24 | 25 | | | | | 0.5 | 2.6 | 2.5 | 2.4 | 2.3 | 2.2 | 2.1 | 2.0 | | | | 1 | 5.3 | 5.0 | 4.7 | 4.5 | 4.2 | 4.0 | 3.7 | | | | 1.5 | 8.0 | 7.5 | 7.1 | 6.7 | 6.3 | 5.9 | 5.5 | | | | 2 | 10.6 | 10.0 | 9.5 | 8.9 | 8.4 | 7.8 | 7.3 | | | | 2.5 | 2.6 | 2.5 | 12.2 | 11.4 | 10.6 | 9.8 | 9.0 | | | | 3 | 5.3 | 5.0 | 14.2 | 13.4 | 12.6 | 11.8 | 11.0 | | |

| TABLE 500.10 CT Values for Inactivation of Virus by Chlorine Dioxide, pH 6.0-9.0 | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | LOG INACTIVATION CREDIT | WATER TEMPERATURE (°C) | | | | | | | | | | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | | | 2 | 8.4 | 7.7 | 7.0 | 6.3 | 5.6 | 5.3 | 5.0 | 4.8 | 4.5 | | 3 | 25.6 | 23.5 | 21.4 | 19.2 | 17.1 | 16.2 | 15.4 | 14.5 | 13.7 | | 4 | 50.1 | 45.9 | 41.8 | 37.6 | 33.4 | 31.7 | 30.1 | 28.4 | 26.8 | | LOG INACTIVATION CREDIT | WATER TEMPERATURE (°C) | | | | | | | | | | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | | | 2 | 4.2 | 3.9 | 3.6 | 3.4 | 3.1 | 2.8 | 2.7 | 2.5 | 2.4 | | 3 | 12.8 | 12.0 | 11.1 | 10.3 | 9.4 | 8.6 | 8.2 | 7.7 | 7.3 | | 4 | 25.1 | 23.4 | 21.7 | 20.1 | 18.4 | 16.7 | 15.9 | 15.0 | 14.2 | | LOG INACTIVATION CREDIT | WATER TEMPERATURE (°C) | | | | | | | | | | 19 | 20 | 21 | 22 | 23 | 24 | 25 | | | | | 2 | 2.2 | 2.1 | 2.0 | 1.8 | 1.7 | 1.5 | 1.4 | | | | 3 | 6.8 | 6.4 | 6.0 | 5.6 | 5.1 | 4.7 | 4.3 | | | | 4 | 13.3 | 12.5 | 11.7 | 10.9 | 10.0 | 9.2 | 8.4 | | |

| TABLE 500.11 CT Values for Inactivation of Giardia lamblia by Chloramines, pH 6.0-9.0 | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | LOG INACTIVATION CREDIT | WATER TEMPERATURE (°C) | | | | | | | | | | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | | | 0.5 | 635 | 568 | 500 | 433 | 365 | 354 | 343 | 332 | 321 | | 1 | 1,270 | 1,136 | 1,003 | 869 | 735 | 711 | 687 | 663 | 639 | | 1.5 | 1,900 | 1,700 | 1,500 | 1,300 | 1,100 | 1,066 | 1,032 | 998 | 964 | | 2 | 2,535 | 2,269 | 2,003 | 1,736 | 1,470 | 1,422 | 1,374 | 1,326 | 1,278 | | 2.5 | 3,170 | 2,835 | 2,500 | 2,165 | 1,830 | 1,772 | 1,714 | 1,656 | 1,598 | | 3 | 3,800 | 3,400 | 3,000 | 2,600 | 2,200 | 2,130 | 2,060 | 1,990 | 1,920 | | LOG INACTIVATION CREDIT | WATER TEMPERATURE (°C) | | | | | | | | | | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | | | 0.5 | 310 | 298 | 286 | 274 | 262 | 250 | 237 | 224 | 211 | | 1 | 615 | 592 | 569 | 546 | 523 | 500 | 474 | 448 | 422 | | 1.5 | 930 | 894 | 858 | 822 | 786 | 750 | 710 | 670 | 630 | | 2 | 1,230 | 1,184 | 1,138 | 1,092 | 1,046 | 1,000 | 947 | 894 | 841 | | 2.5 | 1,540 | 1,482 | 1,424 | 1,366 | 1,308 | 1,250 | 1,183 | 1,116 | 1,049 | | 3 | 1,850 | 1,780 | 1,710 | 1,640 | 1,570 | 1,500 | 1,420 | 1,340 | 1,260 | | LOG INACTIVATION CREDIT | WATER TEMPERATURE (°C) | | | | | | | | | | 19 | 20 | 21 | 22 | 23 | 24 | 25 | | | | | 0.5 | 198 | 185 | 173 | 161 | 149 | 137 | 125 | | | | 1 | 396 | 370 | 346 | 322 | 298 | 274 | 250 | | | | 1.5 | 590 | 550 | 515 | 480 | 445 | 410 | 375 | | | | 2 | 788 | 735 | 688 | 641 | 594 | 547 | 500 | | | | 2.5 | 982 | 915 | 857 | 799 | 741 | 683 | 625 | | | | 3 | 1,180 | 1,100 | 1,030 | 960 | 890 | 820 | 750 | | |

| TABLE 500.12 CT Values for Inactivation of Virus by Chloramines, pH 6.0-9.0 | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | LOG INACTIVATION CREDIT | WATER TEMPERATURE (°C) | | | | | | | | | | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | | | 2 | 1,243 | 1,147 | 1,050 | 954 | 857 | 814 | 771 | 729 | 686 | | 3 | 2,063 | 1,903 | 1,743 | 1,583 | 1,423 | 1,352 | 1,281 | 1,209 | 1,138 | | 4 | 2,883 | 2,659 | 2,436 | 2,212 | 1,988 | 1,889 | 1,789 | 1,690 | 1,590 | | LOG INACTIVATION CREDIT | WATER TEMPERATURE (°C) | | | | | | | | | | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | | | 2 | 643 | 600 | 557 | 514 | 471 | 428 | 407 | 385 | 364 | | 3 | 1,067 | 996 | 925 | 854 | 783 | 712 | 676 | 641 | 605 | | 4 | 1,491 | 1392 | 1292 | 1193 | 1,093 | 994 | 944 | 895 | 845 | | LOG INACTIVATION CREDIT | WATER TEMPERATURE (°C) | | | | | | | | | | 19 | 20 | 21 | 22 | 23 | 24 | 25 | | | | | 2 | 342 | 321 | 300 | 278 | 257 | 235 | 214 | | | | 3 | 570 | 534 | 498 | 463 | 427 | 392 | 356 | | | | 4 | 796 | 746 | 696 | 646 | 597 | 547 | 497 | | |

| TABLE 500.13 CT Values for Inactivation of Giardia lamblia by Ozone | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | LOG INACTIVATION CREDIT | WATER TEMPERATURE (°C) | | | | | | | | | | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | | | 0.5 | 0.48 | 0.44 | 0.40 | 0.36 | 0.32 | 0.30 | 0.28 | 0.27 | 0.25 | | 1 | 0.97 | 0.89 | 0.80 | 0.72 | 0.63 | 0.60 | 0.57 | 0.54 | 0.51 | | 1.5 | 1.50 | 1.36 | 1.23 | 1.09 | 0.95 | 0.90 | 0.86 | 0.81 | 0.77 | | 2 | 1.90 | 1.75 | 1.60 | 1.45 | 1.30 | 1.23 | 1.16 | 1.09 | 1.02 | | 2.5 | 2.40 | 2.20 | 2.00 | 1.80 | 1.60 | 1.52 | 1.44 | 1.36 | 1.28 | | 3 | 2.90 | 2.65 | 2.40 | 2.15 | 1.90 | 1.81 | 1.71 | 1.62 | 1.52 | | LOG INACTIVATION CREDIT | WATER TEMPERATURE (°C) | | | | | | | | | | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | | | 0.5 | 0.23 | 0.22 | 0.20 | 0.19 | 0.17 | 0.16 | 0.15 | 0.14 | 0.14 | | 1 | 0.48 | 0.45 | 0.42 | 0.38 | 0.35 | 0.32 | 0.30 | 0.29 | 0.27 | | 1.5 | 0.72 | 0.67 | 0.62 | 0.58 | 0.53 | 0.48 | 0.46 | 0.43 | 0.41 | | 2 | 0.95 | 0.89 | 0.82 | 0.76 | 0.69 | 0.63 | 0.60 | 0.57 | 0.54 | | 2.5 | 1.20 | 1.12 | 1.04 | 0.95 | 0.87 | 0.79 | 0.75 | 0.71 | 0.68 | | 3 | 1.43 | 1.33 | 1.24 | 1.14 | 1.05 | 0.95 | 0.90 | 0.86 | 0.81 | | LOG INACTIVATION CREDIT | WATER TEMPERATURE (°C) | | | | | | | | | | 19 | 20 | 21 | 22 | 23 | 24 | 25 | | | | | 0.5 | 0.13 | 0.12 | 0.11 | 0.10 | 0.10 | 0.09 | 0.08 | | | | 1 | 0.26 | 0.24 | 0.22 | 0.21 | 0.19 | 0.18 | 0.16 | | | | 1.5 | 0.38 | 0.36 | 0.34 | 0.31 | 0.29 | 0.26 | 0.24 | | | | 2 | 0.51 | 0.48 | 0.45 | 0.42 | 0.38 | 0.35 | 0.32 | | | | 2.5 | 0.64 | 0.60 | 0.56 | 0.52 | 0.48 | 0.44 | 0.40 | | | | 3 | 0.13 | 0.12 | 0.11 | 0.10 | 0.10 | 0.09 | 0.08 | | |

| TABLE 500.14 CT Values for Inactivation of Virus by Ozone | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | LOG INACTIVATION CREDIT | WATER TEMPERATURE (°C) | | | | | | | | | | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | | | 2 | 0.90 | 0.83 | 0.75 | 0.68 | 0.60 | 0.58 | 0.56 | 0.54 | 0.52 | | 3 | 1.40 | 1.28 | 1.15 | 1.03 | 0.90 | 0.88 | 0.86 | 0.84 | 0.82 | | 4 | 1.80 | 1.65 | 1.50 | 1.35 | 1.20 | 1.16 | 1.12 | 1.08 | 1.04 | | LOG INACTIVATION CREDIT | WATER TEMPERATURE (°C) | | | | | | | | | | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | | | 2 | 0.50 | 0.46 | 0.42 | 0.38 | 0.34 | 0.30 | 0.29 | 0.28 | 0.27 | | 3 | 0.80 | 0.74 | 0.68 | 0.62 | 0.56 | 0.50 | 0.48 | 0.46 | 0.44 | | 4 | 1.00 | 0.92 | 0.84 | 0.76 | 0.68 | 0.60 | 0.58 | 0.56 | 0.54 | | LOG INACTIVATION CREDIT | WATER TEMPERATURE (°C) | | | | | | | | | | 19 | 20 | 21 | 22 | 23 | 24 | 25 | | | | | 2 | 0.26 | 0.25 | 0.23 | 0.21 | 0.19 | 0.17 | 0.15 | | | | 3 | 0.42 | 0.40 | 0.37 | 0.34 | 0.31 | 0.28 | 0.25 | | | | 4 | 0.52 | 0.50 | 0.46 | 0.42 | 0.38 | 0.34 | 0.30 | | |

| TABLE 500.15 Baffling Classifications | | | | --- | --- | --- | | BAFFLING CONDITION | T₁₀/T | BAFFLING DESCRIPTION | | Unbaffled (mixed flow) | 0.1 | None, agitated basin, very low length-to-width ratio, high inlet and outlet flow velocities | | Poor | 0.3 | Single or multiple unbaffled inlets and outlets, no intra-basin baffles | | Average | 0.5 | Baffled inlet or outlet with some intra-basin baffles | | Superior | 0.7 | Perforated inlet baffle, serpentine or perforated intra-basin baffles, outlet weir or perforated launders |

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-005.06 § 2.17, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 18, Issue 19, eff. July 3, 2002; Volume 21, Issue 13, eff. April 6, 2005; Volume 25, Issue 5, eff. December 10, 2008; Volume 28, Issue 5, eff. December 7, 2011; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-505 Emergency management plan for extended power outages

A. The owner of a community waterworks (including consecutive waterworks) shall develop and maintain an emergency management plan for extended power outages.

B. The plan shall be kept current and shall be retained at a location that is readily accessible to the owner in the event of an extended power outage.

C. The owner of a community waterworks shall certify in writing to the department that the plan has been completed.

D. The plan shall address the following where applicable:

1. Identification of the criteria (events, duration of power outage, etc.) that will initiate activation of the plan.

2. How the owner will respond to an extended power outage lasting a minimum of five days.

3. Procedures for obtaining and distributing potable water in the event that the primary sources become unavailable.

4. Notification procedures and example notices to the public and media (local radio stations, television stations, local newspapers, etc.) including conservation notices and boil water advisories.

5. Emergency disinfection procedures for the distribution system and storage tank.

6. The point of contact for the department.

7. The points of contact for the waterworks personnel who should be notified.

8. The point of contact for the Local Emergency Coordinator designated by the Virginia Department of Emergency Management.

9. The points of contact for the electric power, natural gas, and propane distributors, or other energy supplier to the waterworks.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 1, eff. October 18, 2006; amended, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-510 Acceptable operating practices

A. This section is not intended to be all inclusive but reflects the concern for the public health significance of certain practices related to waterworks operation.

B. Filter operation.

1. Gravity flow granular media filters designed for pathogen and turbidity removal shall not be operated without adequate chemical coagulation as determined by the department.

2. A waterworks utilizing gravity flow granular media filtration shall not vary the rate of filtration through any single filter above its design capacity unless approved by the department.

3. Gravity flow granular media filters equipped with filter-to-waste facilities shall not be returned to service after backwashing until a thorough rinsing period has occurred so that the filter-to-waste water has a turbidity less than or equal to 0.3 NTU.

4. All MF and UF technologies employed for pathogen removal shall demonstrate removal efficiency equal to the removal (log inactivation) credit given in Table 500.1. A direct integrity test acceptable to the department shall be conducted and include the following:

a. The direct integrity test capability shall be provided for each filter unit; and

b. The direct integrity test shall be conducted at least daily for each day the filtration unit is in operation.

C. All waterworks shall provide a minimum working pressure of 20 psigauge (psig) at all service connections.

D. The board recommends that all community waterworks in the Commonwealth deliver the optimum fluoride ion concentration as determined by the U.S. Department of Health and Human Services.

E. A waterworks owner shall provide the commissioner at least 90 days prior written notice of the intent to initiate or discontinue a program to provide the optimum fluoride ion concentration.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-005.07 § 2.18, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-515 Use of chemicals

A. All chemicals used in water treatment shall be compliant with NSF/ANSI/CAN Standard 60-2020. These chemicals shall include the following:

1. Corrosion and scale inhibitors;

2. Coagulants and flocculants;

3. Disinfectants and oxidants;

4. pH adjustment chemicals;

5. Regenerating agents; and

6. Membrane cleaning compounds.

B. Chemical containers shall bear the proper certification mark and identification consistent with the Safety Data Sheet for the chemical used.

C. The owner shall maintain documentation verifying that all chemicals meet NSF/ANSI/CAN Standard 60-2020 certification requirements.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-520 Waterworks capacity

A. When the water production of a community waterworks reaches 80% of the permitted capacity for any consecutive three-month period, the owner shall prepare and submit a written plan within 30 days of notification by the department to address capacity needs. This plan shall be evaluated by the department and corrective actions shall be approved by the department.

B. The department may require the owner to reevaluate the source water capacity of a well by conducting a yield and drawdown test in accordance with 12VAC5-590-840 H when the well has demonstrated declining yield.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-005.08 § 2.19, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-530 Reporting

A. The results of all required monitoring activity shall be reported by the owner or the owner's authorized agent to the department no later than (i) the 10th day of the month following the month during which the test results were received, or (ii) the 10th day following the end of the monitoring period, whichever is shorter, unless stipulated otherwise by the department. The results of any required monitoring activity shall be reported by the owner or the owner's authorized agent in a format and method prescribed by the department. For routine compliance samples analyzed for contaminants listed in Tables 340.1 through 340.7, the owner shall request that the certified analytical laboratory performing the analyses provide the data electronically to the department as per the requirements of this section.

B. It shall be the duty and responsibility of an owner to report to the department in the most expeditious manner for circumstances identified in subsections C through J of this section. The owner shall contact the department for the acceptable notification method. The official laboratory data report shall be sent to the department as soon as practical.

C. Bacteriological examination reporting.

1. When a bacteriological examination shows that samples are required (see 12VAC5-590-380 D), the owner shall collect the repeat samples within 24 hours of being notified of the positive result and shall report the repeat sample results to the department.

2. Microbial contamination, as evidenced by one or more routine distribution system water samples indicating the presence of E. coli or waterborne pathogens, shall be reported by the owner to the department by the end of the day when the owner was notified of the test result, unless the department is closed, in which case the department shall be notified before the end of the next business day.

3. An E. coli PMCL violation shall be reported by the owner to the department by the end of the day when the owner was notified of the test result, unless the department is closed, in which case the department shall be notified before the end of the next business day.

4. The owner who has failed to comply with the monitoring requirements of 12VAC5-590-370 shall report the monitoring violation to the department in writing within 10 days after the owner discovers the violation and shall notify the public in accordance with 12VAC5-590-540 A 3.

D. Turbidity reporting. For a waterworks required to filter for pathogen and turbidity removal, a report shall be made within 24 hours to the department if the filtered water turbidity measurement exceeds the following concentrations based on the filtration treatment type:

1. Conventional filtration -- one NTU.

2. Diatomaceous earth filtration -- five NTU.

3. Slow sand filtration -- five NTU.

4. Membrane, bag and cartridge filtration -- one NTU.

E. PMCL exceedance.

1. When a PMCL of an inorganic or organic chemical is exceeded for a single sample the owner shall report the exceedance within seven days. If a sample result would cause the compliance average to be exceeded, then the owner shall report the sample result, in context with the compliance average, to the department within 48 hours.

2. When the average value of the samples collected pursuant to 12VAC5-590-382 and 12VAC5-590-383 exceeds the PMCL of an inorganic or organic chemical, the owner shall report the exceedance to the department within 48 hours.

3. When the PMCL for a radionuclide has been exceeded as determined by Table 340.4, the results shall be reported to the department within 48 hours.

F. The owner shall report to the department within 48 hours of the failure to comply with the monitoring and sanitary survey requirements of this chapter.

G. The owner shall report to the department within 48 hours of the failure to comply with the requirements of the schedule prescribed pursuant to a variance or exemption.

H. The owner shall report a Tier 1 violation or situation, as described in 12VAC5-590-540 A 1, to the department as soon as practical, but no later than 24 hours after the owner learns of the Tier 1 violation or situation. At the same time the report is made, the owner shall consult with the department to determine the need for any additional actions to address the violation or situation.

I. Reporting requirements for coliform treatment technique violations.

1. The owner that has violated the treatment technique required in 12VAC5-590-392 B shall report the violation to the department no later than the end of the next business day after learning of the violation and shall notify the public in accordance with 12VAC5-590-540 A 2.

2. The owner that is required to conduct an assessment under 12VAC5-590-392 C shall submit the assessment report within 30 days to the department.

3. The owner shall notify the department in writing after each scheduled corrective action is completed for corrections that were not completed by the time of submission of the assessment form under the requirements of 12VAC5-590-392 C.

J. The owner of a seasonal waterworks shall submit the certification of completion of the approved start-up procedure on a form approved by the department before serving water.

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K. Reporting requirements for groundwater systems. The owner shall report the following information in accordance with subsection A of this section:

1. The owner conducting compliance monitoring as required by 12VAC5-590-421 C shall notify the department as soon as practical, but no later than the next business day, whenever the groundwater system fails to meet the department-specified minimum residual disinfectant concentration for more than four hours.

2. The owner required to conduct corrective action as described in 12VAC5-590-421 A shall notify the department within 30 days of completion of corrective action.

3. The owner subject to the source water monitoring requirements of 12VAC5-590-379 that do not conduct this monitoring under the provision of 12VAC5-590-380 E shall provide documentation to the department within 30 days of the collection that the sample met the criteria defined in 12VAC5-590-380 E.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-005.09 § 2.20, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 12, Issue 2, eff. November 15, 1995; Volume 18, Issue 19, eff. July 3, 2002; Volume 19, Issue 17, eff. June 4, 2003; Volume 19, Issue 20, eff. July 16, 2003; Volume 19, Issue 24, eff. September 10, 2003; Volume 21, Issue 13, eff. April 6, 2005; Volume 22, Issue 21, eff. July 26, 2006; Volume 25, Issue 5, eff. December 10, 2008; Volume 27, Issue 1, eff. October 13, 2010; Volume 28, Issue 5, eff. December 7, 2011; Volume 33, Issue 3, eff. November 2, 2016; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-531 Reporting requirements for filtration treatment and disinfection treatment

A. The owner of a waterworks using a surface water source, a GUDI source, or both shall report monthly to the department the following specified information.

1. Turbidity measurements as required by 12VAC5-590-376 B shall be reported within 10 days after the end of each month the waterworks serves water to the public. Information that shall be reported includes:

a. The total number of filtered water turbidity measurements collected during the month.

b. The number and percentage of filtered water turbidity measurements collected during the month that are less than or equal to the turbidity limits specified in 12VAC5-590-395 A 2 b for the filtration technology being used.

c. The owner of a waterworks that uses lime softening may apply to the department for alternative exceedance levels for the levels specified in subdivision A 1 b of this section if the owner can demonstrate that higher turbidity levels in individual filters are due to lime carryover only and not due to degraded filter performance.

2. The owner of a waterworks with combined distribution systems serving at least 10,000 persons using a surface water source, a GUDI source, or both that provides conventional filtration treatment or direct filtration shall report monthly to the department the information specified in subdivisions A 2 a and A 2 b of this section. Also, the owner of a waterworks that provides filtration approved under 12VAC5-590-395 A 2 b shall report monthly to the department the information specified in subdivisions A 2 a and A 2 b of this section.

a. Turbidity measurements collected to meet 12VAC5-590-395 A 2 b shall be reported within 10 days after the end of each month the waterworks serves water to the public. Information that shall be reported includes:

(1) The total number of filtered water turbidity measurements collected during the month.

(2) The number and percentage of filtered water turbidity measurements collected during the month that are less than or equal to the turbidity limits specified in 12VAC5-590-395 A 2 b.

(3) The date and value of any turbidity measurements collected during the month that exceed 1.0 NTU for waterworks using conventional filtration treatment or direct filtration or that exceed the maximum level set by the department under 12VAC5-590-395 A 2 b.

b. The owner shall maintain the results of individual filter monitoring collected under 12VAC5-590-376 B for at least three years. The owner shall report the completion of individual filter turbidity monitoring under 12VAC5-590-376 B within 10 days after the end of each month the waterworks serves water to the public. The owner shall report individual filter turbidity measurement results collected under 12VAC5-590-376 B within 10 days after the end of each month the waterworks serves water to the public only if measurements demonstrate one or more of the conditions in 12VAC5-590-395 A 2 b. The owner of a waterworks that uses lime softening may apply to the department for alternative exceedance levels for the levels specified in 12VAC5-590-395 A 2 b if the owner can demonstrate that higher turbidity levels in individual filters are due to lime carryover only and not due to degraded filter performance.

3. For a waterworks with combined distribution systems serving 10,000 or more persons.

a. For an individual filter that has a measured turbidity level of greater than 1.0 NTU in two consecutive measurements collected 15 minutes apart, the owner shall report the filter number, the turbidity measurement, and the dates on which the exceedances occurred. In addition, the owner shall either produce a filter profile for the filter within seven days of the exceedance if the owner is not able to identify an obvious reason for the abnormal filter performance and report that the profile has been produced or report the obvious reason for the exceedance.

b. For an individual filter that has a measured turbidity level of greater than 0.5 NTU in two consecutive measurements collected 15 minutes apart at the end of the first four hours of continuous filter operation after the filter has been backwashed or otherwise taken offline, the owner shall report the filter number, the turbidity, and the dates on which the exceedances occurred. In addition, the owner shall either produce a filter profile for the filter within seven days of the exceedance if the owner is not able to identify an obvious reason for the abnormal filter performance and report that the profile has been produced or report the obvious reason for the exceedance.

c. For an individual filter that has a measured turbidity level of greater than 1.0 NTU in two consecutive measurements collected 15 minutes apart at any time in each of three consecutive months, the owner shall report the filter number, the turbidity measurement, and the dates on which the exceedances occurred. In addition, the waterworks shall conduct a self-assessment of the filter within 14 days of the exceedances and report that the self-assessment was conducted. The self-assessment shall consist of at least the following components: assessment of filter performance, development of a filter profile, identification and prioritization of factors limiting filter performance, assessment of the applicability of corrections, and preparation of a filter self-assessment report.

d. For an individual filter that has a measured turbidity level of greater than 2.0 NTU in two consecutive measurements collected 15 minutes apart at any time in each of two consecutive months, the owner shall report the filter number, the turbidity measurement, and the dates on which the exceedances occurred. In addition, the owner shall arrange for the conduct of a comprehensive performance evaluation (CPE) by the department or a third party approved by the department no later than 30 days following the exceedance and have the evaluation completed and submitted to the department no later than 90 days following the exceedance. A CPE means a thorough evaluation and analysis of a water treatment plant's performance-based capabilities and associated administrative, operational, and maintenance practices. A CPE is conducted to identify factors that may be adversely impacting a water treatment plant's capability to achieve compliance and emphasizes approaches that can be implemented without significant capital improvements.

4. For a waterworks with combined distribution systems serving fewer than 10,000 persons.

a. For an individual filter or the turbidity of CFE for waterworks with two filters that monitor CFE instead of individual filters that has a measured turbidity level of greater than 1.0 NTU in two consecutive measurements collected 15 minutes apart, the owner shall report the filter numbers, the turbidity measurements, and the dates on which the exceedances occurred and the cause (if known) for the exceedances.

b. For an individual filter or the turbidity of CFE for a waterworks with two filters that monitor CFE instead of individual filters that has a measured turbidity level of greater than 1.0 NTU in two consecutive measurements collected 15 minutes apart at any time in each of three consecutive months, the owner shall conduct a self-assessment of the filters within 14 days of the day the filter exceeded 1.0 NTU unless a CPE as specified in subdivision A 4 c of this section was required. A waterworks with two filters that monitor the CFE instead of individual filters shall conduct a self-assessment on both filters. The self-assessment shall be reported to the department and consist of at least the following components: (i) date the self-assessment was triggered, (ii) date the self-assessment was completed, (iii) an assessment of filter performance, (iv) development of a filter profile, (v) identification and prioritization of factors limiting filter performance, (vi) assessment of the applicability of corrections, and (vii) preparation of a filter self-assessment report. The self-assessment shall be submitted within 10 days after the end of the month or 14 days after the self-assessment was triggered only if it was triggered during the last four days of the month.

c. For an individual filter or the turbidity of CFE for a waterworks with two filters that monitor CFE instead of individual filters that has a measured turbidity level of greater than 2.0 NTU in two consecutive measurements collected 15 minutes apart at any time in each of two consecutive months, the owner shall arrange for a CPE, as defined in subdivision A 3 d of this section, by the department or a third party approved by the department no later than 60 days following the day the filter exceeded 2.0 NTU in two consecutive months. The owner shall report within 10 days after the end of the month that a CPE is required and the date that it was triggered. If a CPE has been completed by the department or a third party approved by the department within the 12 prior months or the owner and the department are jointly participating in an ongoing comprehensive technical assistance project at the waterworks, then a new CPE is not required. If conducted, a CPE shall be completed and submitted to the department no later than 120 days following the day the filter exceeded 2.0 NTU in two consecutive measurements for the second straight month.

5. Reporting Cryptosporidium monitoring results.

a. The owner shall report results from the source water monitoring required in 12VAC5-590-401 B no later than 10 days after the end of the first month following the month when the sample is collected.

b. The owner shall report the following data elements for each Cryptosporidium analysis:

(1) Public water system (PWS) identification number;

(2) Facility identification number;

(3) Sample collection date;

(4) Sample type (field or matrix spike);

(5) Sample volume filtered (L), to nearest 1/4 L;

(6) Was 100% of filtered volume examined; and

(7) Number of oocysts counted.

c. Quality control for Cryptosporidium analysis:

(1) For matrix spike samples, the owner shall also report the sample volume spiked and the estimated number of oocysts spiked. These data are not required for field samples.

(2) For samples in which less than 10 L is filtered or less than 100% of the sample volume is examined, the owner shall also report the number of filters used and the packed pellet volume.

(3) For samples in which less than 100% of the sample volume is examined, the owner shall also report the volume of re-suspended concentrate and volume of this re-suspension processed through immunomagnetic separation.

d. The owner shall report the following data elements for each E. coli analysis:

(1) PWS identification number;

(2) Facility identification number;

(3) Sample collection date;

(4) Analytical method number;

(5) Method type;

(6) Source water type (flowing stream, lake or reservoir, GUDI source);

(7) E. coli/100 mL; and

(8) Turbidity.

e. The owner of a waterworks serving fewer than 10,000 persons and not required to monitor for turbidity under 12VAC5-590-401 B is not required to report turbidity with their E. coli results.

B. Reporting of requirements for enhanced treatment for Cryptosporidium.

1. The owner shall report sampling schedules under 12VAC5-590-401 Band source water monitoring results under 12VAC5-590-531 A 5, unless the owner notifies the department that the owner will not conduct source water monitoring due to meeting the criteria of 12VAC5-590-401 B 4.

2. The owner shall report the use of uncovered finished water storage facilities to the department as described in 12VAC5-590-415.

3. The owner of a waterworks that provide filtration shall report their Cryptosporidium bin classification as described in 12VAC5-590-401 D.

4. The owner shall report disinfection profiles and benchmarks to the department as described in 12VAC5-590-401 C 1 and C 2 before making a significant change in disinfection practice.

5. The owner shall report to the department in accordance with Table 531.1 for any microbial toolbox options used to comply with treatment requirements under 12VAC5-590-401 D 2. Alternatively, the department may approve a waterworks to certify operation within required parameters for treatment credit rather than reporting monthly operational data for toolbox options.

| TABLE 531.1 Microbial Toolbox Reporting Requirements | | | | --- | --- | --- | | TOOLBOX OPTION | OWNERS SHALL SUBMIT THE FOLLOWING INFORMATION: | ON THE FOLLOWING SCHEDULE: | | Alternative source or intake management | Verification that the waterworks has relocated the intake or adopted the intake withdrawal procedure reflected in monitoring results. | No later than the applicable treatment compliance date in 12VAC5-590-401 D 3. | | Presedimentation | Monthly verification of the following: (i) Continuous basin operation; (ii) Treatment of 100% of the flow; (iii) Continuous addition of a coagulant; and (iv) At least 0.5-log mean reduction of influent turbidity or compliance with alternative performance criteria approved by the department. | Monthly reporting within 10 days following the month in which the monitoring was conducted, beginning on the applicable treatment compliance date in 12VAC5-590-401 D 3. | | Two-stage lime softening | Monthly verification of the following: (i) Chemical addition and hardness precipitation occurred in two separate and sequential softening stages before filtration; and (ii) Both stages treated 100% of the water treatment plant flow. | Monthly reporting within 10 days following the month in which the monitoring was conducted, beginning on the applicable treatment compliance date in 12VAC5-590-401 D 3. | | Bank filtration | Initial demonstration of the following: (i) Unconsolidated, predominantly sandy aquifer; and (ii) Setback distance of at least 25 ft. (0.5-log credit) or 50 ft. (1.0-log credit). | No later than the applicable treatment compliance date in 12VAC5-590-401 D 3. | | If monthly average of daily maximum turbidity is greater than 1.0 NTU then the waterworks shall report the result and submit an assessment of the cause. | Report within 30 days following the month in which the monitoring was conducted, beginning on the applicable treatment compliance date in 12VAC5-590-401 D 3. | | | Combined filter performance | Monthly verification of CFE turbidity levels less than or equal to 0.15 NTU in at least 95% of the four-hour CFE measurements collected each month. | Monthly reporting within 10 days following the month in which the monitoring was conducted, beginning on the applicable treatment compliance date in 12VAC5-590-401 D 3. | | Individual filter performance | Monthly verification of the following: (i) Individual filter effluent turbidity levels less than or equal to 0.15 NTU in at least 95% of samples each month in each filter; and (ii) No individual filter greater than 0.3 NTU in two consecutive readings 15 minutes apart. | Monthly reporting within 10 days following the month in which the monitoring was conducted, beginning on the applicable treatment compliance date in 12VAC5-590-401 D 3. | | Demonstration of performance | Results from testing following a protocol approved by the department. | No later than the applicable treatment compliance date in 12VAC5-590-401 D 3. | | As required by the department, monthly verification of operation within conditions of the department's approval for demonstration of performance credit. | Within 10 days following the month in which monitoring was conducted, beginning on the applicable treatment compliance date in 12VAC5-590-401 D 3. | | | Bag filters and cartridge filters | Demonstration that the following criteria are met: (i) Process meets the definition of bag or cartridge filtration; and (ii) Removal efficiency established through challenge testing that meets criteria in 12VAC5-590-401 E 6 a. | No later than the applicable treatment compliance date in 12VAC5-590-401 D 3. | | Monthly verification that 100% of the water treatment plant flow was filtered. | Within 10 days following the month in which monitoring was conducted, beginning on the applicable treatment compliance date in 12VAC5-590-401 D 3. | | | Membrane filtration | Results of verification testing demonstrating the following: (i) Removal efficiency established through challenge testing that meets criteria in subdivision B 5 of this section; and (ii) Integrity test method and parameters, including resolution, sensitivity, test frequency, control limits, and associated baseline. | No later than the applicable treatment compliance date in 12VAC5-590-401 D 3. | | Monthly report summarizing the following: (i) All direct integrity tests above the control limit; and (ii) If applicable, any turbidity or alternative indirect integrity monitoring approved by the department that results in triggering direct integrity testing and the corrective action that was taken. | Within 10 days following the month in which monitoring was conducted, beginning on the applicable treatment compliance date in 12VAC5-590-401 D 3. | | | Second stage filtration | Monthly verification that 100% of flow was filtered through both stages and the first stage was preceded by a coagulation step. | Within 10 days following the month in which monitoring was conducted, beginning on the applicable treatment compliance date in 12VAC5-590-401 D 3. | | Slow sand filtration (as secondary filter) | Monthly verification that both a slow sand filter and a preceding separate stage of filtration treated 100% of flow from surface water or GUDI. | Within 10 days following the month in which monitoring was conducted, beginning on the applicable treatment compliance date in 12VAC5-590-401 D 3. | | Chlorine dioxide | Summary of CT values for each day as described in 12VAC5-590-401 E 7 b (1). | Within 10 days following the month in which monitoring was conducted, beginning on the applicable treatment compliance date in 12VAC5-590-401 D 3. | | Ozone | Summary of CT values for each day as described in 12VAC5-590-401 E 7 b (2). | Within 10 days following the month in which monitoring was conducted, beginning on the applicable treatment compliance date in 12VAC5-590-401D 3. | | UV | Validation test results demonstrating operating conditions that achieve required UV dose. | No later than the applicable treatment compliance date in 12VAC5-590-401 D 3. | | Monthly report summarizing the percentage of water entering the distribution system that was not treated by UV reactors operating within validated conditions for the required dose as specified in 12VAC5-590-401 E 7 c (1). | Within 10 days following the month in which monitoring was conducted, beginning on the applicable treatment compliance date in 12VAC5-590-401 D 3. | |

C. Disinfection information specified in this subsection shall be reported to the department within 10 days after the end of each month the waterworks serves water to the public. Information that shall be reported includes:

1. For each day, the lowest measurement of residual disinfectant concentration in mg/L in water entering the distribution system.

2. The date and duration of each period when the residual disinfectant concentration in water entering the distribution system fell below 0.2 mg/L and when the department was notified of the occurrence.

3. The following information on the samples collected in the distribution system in conjunction with total coliform monitoring pursuant to 12VAC5-590-395 A 2.

a. Number of instances where the residual disinfectant concentration is measured;

b. Number of instances where the residual disinfectant concentration is not measured but HPC is measured;

c. Number of instances where the residual disinfectant concentration is measured but not detected and no HPC is measured;

d. Number of instances where no residual disinfectant concentration is detected and where HPC is greater than 500/mL;

e. Number of instances where the residual disinfectant concentration is not measured and HPC is greater than 500/mL; and

f. For the current and previous month the waterworks serves water to the public, the value of "V," in percent, in the following formula:

| | | --- |

a = the value in subdivision C 3 a of this section.

b = the value in subdivision C 3 b of this section.

c = the value in subdivision C 3 c of this section.

d = the value in subdivision C 3 d of this section.

e = the value in subdivision C 3 e of this section.

g. The department may determine that based on site-specific considerations if an owner has no means for having a sample transported and analyzed for HPC by a certified laboratory under the requisite time and temperature conditions and the waterworks is providing adequate disinfection in the distribution system, the HPC compliance requirements of subdivisions C 3 a through C 3 f of this section do not apply.

4. The owner need not report the data listed in subdivision C 1 of this section if all data listed in subdivisions C 1, C 2, and C 3 of this section remain on file at the waterworks and the department determines that the owner has submitted all of the information required by subdivisions C 1, C 2, and C 3 of this section for the last 12 months.

5. A waterworks using disinfection oxidants other than free chlorine after filtration shall continue to record disinfection profile measurements and incorporate log inactivation computations into their monthly operation reports, as described in 12VAC5-590-570.

D. Reporting requirements for DBPs. The owner shall report the following information to the department in accordance with 12VAC5-590-530. The department may choose to perform calculations and determine whether the PMCL was violated, instead of having the owner report that information.

1. Locational running annual average (LRAA) reporting:

a. The owner shall report the following information for each monitoring location to the department:

(1) Number of samples collected during the last quarter.

(2) Date and results of each sample collected during the last quarter.

(3) Arithmetic average of quarterly results for the last four quarters for each LRAA, beginning at the end of the fourth calendar quarter that follows the compliance date and at the end of each subsequent quarter. If the LRAA calculated based on fewer than four quarters of data would cause the PMCL to be exceeded regardless of the monitoring results of subsequent quarters, the owner shall report this information to the department as part of the first report due following the compliance date or anytime thereafter that this determination is made. If the owner is required to conduct monitoring at a frequency that is less than quarterly, then the owner shall make compliance calculations beginning with the first compliance sample collected after the compliance date, unless the owner is required to conduct increased monitoring under 12VAC5-590-374 F 5.

(4) Whether, based on 12VAC5-590-384 B 1, the PMCL was violated at any monitoring location.

(5) Any operational evaluation levels under 12VAC5-590-384 B 1 d that were exceeded during the quarter, and if so, the location and date and the calculated TTHM and HAA5 levels.

b. The owner of a waterworks using a surface water source, a GUDI source, or both seeking to qualify for or remain on reduced TTHM and HAA5 monitoring shall report the following source water TOC information for each water treatment plant that treats surface water or groundwater under the direct influence of surface water to the department within 10 days of the end of any quarter in which monitoring is required:

(1) The number of source water TOC samples collected each month during last quarter.

(2) The date and result of each sample collected during last quarter.

(3) The quarterly average of monthly samples collected during last quarter or the result of the quarterly sample.

(4) The RAA of quarterly averages from the past four quarters.

(5) Whether the RAA exceeded 4.0 mg/L.

2. The owner of a waterworks monitoring for chlorite under the requirements of 12VAC5-590-374 G shall report:

a. The number of entry point samples collected each month for the last three months.

b. The location, date, and result of each sample (both entry point and distribution system) collected during the last quarter.

c. For each month in the reporting period, the arithmetic average of all samples collected in each three sample set collected in the distribution system.

d. Whether, based on 12VAC5-590-384 B 3, the PMCL was violated, in which month, and how many times it was violated each month.

3. The owner of a waterworks monitoring for bromate under the requirements of 12VAC5-590-374 H shall report:

a. The number of samples collected during the last quarter.

b. The location, date, and result of each sample collected during the last quarter.

c. The arithmetic average of the monthly arithmetic averages of all samples collected in the last year.

d. Whether, based on 12VAC5-590-384 B 2, the PMCL was violated.

E. Reporting requirements for disinfectants. The owner shall report the information specified in this subsection to the department in accordance with 12VAC5-590-530. The department may choose to perform calculations and determine whether the MRDL was violated, instead of having the owner report that information:

1. The owner of a waterworks monitoring for chlorine or chloramines under the requirements of 12VAC5-590-374 I 1 shall report:

a. The number of samples collected during each month of the last quarter.

b. The monthly arithmetic average of all samples collected in each month for the last 12 months.

c. The arithmetic average of all monthly averages for the last 12 months.

d. Whether, based on 12VAC5-590-384 C 1, the MRDL was violated.

2. The owner of a waterworks monitoring for chlorine dioxide under the requirements of 12VAC5-590-374 I 2shall report:

a. The dates, results, and locations of samples collected during the last quarter.

b. Whether, based on 12VAC5-590-384 C 2, the MRDL was violated.

c. Whether the MRDL was exceeded in any two consecutive daily samples and whether the resulting violation was acute or nonacute.

F. Reporting requirements for DBPPs and enhanced coagulation or enhanced softening. The owner shall report the following information to the department in accordance with 12VAC5-590-530. The department may choose to perform calculations and determine whether the treatment technique was met, instead of having the owner report that information:

1. The owner of a waterworks monitoring monthly or quarterly for TOC under the requirements of 12VAC5-590-374 J and required to meet the enhanced coagulation or enhanced softening requirements in 12VAC5-590-411 A 2shall report:

a. The number of paired (source water and treated water) samples collected during the last quarter.

b. The location, date, and results of each paired sample and associated alkalinity collected during the last quarter.

c. For each month in the reporting period that paired samples were collected, the arithmetic average of the percent reduction of TOC for each paired sample and the required TOC percent removal.

d. Calculations for determining compliance with the TOC percentage removal requirements, as provided in 12VAC5-590-411 A 3.

e. Whether the waterworks is in compliance with the enhanced coagulation or enhanced softening percent removal requirements in 12VAC5-590-411 A 2 for the last four quarters.

2. The owner of a waterworks monitoring monthly or quarterly for TOC under the requirements of 12VAC5-590-374 J and meeting one or more of the alternative compliance criteria in 12VAC5-590-411 A 1 c or A 1 d shall report:

a. The alternative compliance criterion that the waterworks is using.

b. The number of paired samples collected during the last quarter.

c. The location, date, and result of each paired sample and associated alkalinity collected during the last quarter.

d. The running annual arithmetic average based on monthly averages (or quarterly samples) of source water TOC for a waterworks meeting a criterion in 12VAC5-590-411 A 1 c (1) or A 1 c (3) or of treated water TOC for waterworks meeting the criterion in 12VAC5-590-411 A 1 c (2).

e. The running annual arithmetic average based on monthly averages (or quarterly samples) of source water SUVA for a waterworks meeting the criterion in 12VAC5-590-411 A 1 c (5) or of treated water SUVA for a waterworks meeting the criterion in 12VAC5-590-411 A 1 c (6).

f. The RAA of source water alkalinity for a waterworks meeting the criterion in 12VAC5-590-411 A 1 c (3) and of treated water alkalinity for a waterworks meeting the criterion in 12VAC5-590-411 A 1 d (1).

g. The RAA for both TTHM and HAA5 for a waterworks meeting the criterion in 12VAC5-590-411 A 1 c (3) or A 1 c (4).

h. The RAA of the amount of magnesium hardness removal (as CaCO₃, in mg/L) for a waterworks meeting the criterion in 12VAC5-590-411 ) A 1 d (2).

i. Whether the waterworks is in compliance with the particular alternative compliance criterion in 12VAC5-590-411 A 1 c or A 1 d.

G. Additional reporting requirements. The owner shall report the following incidents within 24 hours to the department:

1. A waterborne disease outbreak that is potentially attributable to that waterworks.

2. Chlorine residual of below 0.2 mg/L in the water entering the distribution system. The owner also shall notify the department by the end of the next business day whether or not the residual was restored to at least 0.2 mg/L within four hours.

History

• Statutory Authority: §§ 32.-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-532 Reporting requirements for lead and copper

A. The owner shall report all of the information in this section to the department in accordance with this section.

B. Reporting requirements for tap water monitoring for lead and copper and for water quality parameter monitoring.

1. Except as provided in subdivision B 1 g of this section, the owner shall report the information specified in this subsection for all tap water samples specified in 12VAC5-590-375 B and for all water quality parameter samples specified in 12VAC5-590-375 C within the first 10 days following the end of each applicable monitoring period specified in 12VAC5-590-375 B and C (i.e., every six months, annually, every three years, or every nine years). For monitoring periods with a duration less than six months, the end of the monitoring period is the last date samples can be collected during the period as specified in 12VAC5-590-375 B and C.

a. The results of all tap samples for lead and copper including location or a location site code and the criteria under 12VAC5-590-375 B 1 c through B 1 f or 12VAC5-590-375 C under which the site was selected for the waterworks sampling pool.

b. Documentation for each tap water lead or copper sample for which the owner requests invalidation pursuant to 12VAC5-590-375 B 6.

c. The 90th percentile lead and copper concentrations measured from among all lead and copper tap water samples collected during each monitoring period (calculated in accordance with 12VAC5-590-385 C) unless the department calculates the 90th percentile lead and copper levels under subsection I of this section.

d. With the exception of initial tap sampling conducted pursuant to 12VAC5-590-375 B 4 a, the owner shall designate any site that was not sampled during previous monitoring periods and include an explanation of why sampling sites have changed.

e. The results of all tap samples for pH, and where applicable, alkalinity, calcium, conductivity, temperature, and orthophosphate or silica collected under 12VAC5-590-375 C 2 through C 5.

f. The results of all samples collected at the entry point to the distribution system for applicable water quality parameters under 12VAC5-590-375 C 2 through C 5.

g. The owner shall report the results of all water quality parameter samples collected under 12VAC5-590-375 C 3 through 12VAC5-590-375 C 6 during each six month monitoring period specified in 12VAC5-590-375 C 4 within the first 10 days following the end of the monitoring period unless the department has specified a more frequent reporting requirement.

2. The owner of a NTNC, or a community waterworks meeting the criteria of 12VAC5-590-405 D 2 e, that does not have enough taps that can provide first-draw samples must either:

a. Provide written documentation to the department identifying standing times and locations for enough non-first-draw samples to make up the sampling pool under 12VAC5-590-375 B 2 e by the start of the first applicable monitoring period under 12VAC5-590-375 B 4, unless the department has waived prior approval of non-first-draw sample sites selected by the owner pursuant to 12VAC5-590-375 B 2 e; or

b. If the department has waived prior approval of non-first-draw sample sites selected by the owner, then the owner shall identify in writing each site that did not meet the six-hour minimum standing time and the length of standing time for that particular substitute sample collected pursuant to 12VAC5-590-375 B 2 e and include this information with the lead and copper sample results required to be submitted pursuant to subsection B of this section.

3. At a time specified by the department, or if no specific time is designated by the department, then as early as practical before the addition of a new source or any long-term change in water treatment, an owner (i) deemed to have optimized corrosion control under 12VAC5-590-405 A 2 b (3), (ii) subject to reduced monitoring pursuant to 12VAC5-590-375 B 4 d, or (iii) subject to a monitoring waiver pursuant to 12VAC5-590-375 B 7 shall submit written documentation to the department describing the change or addition. The department must approve the addition of a new source or a long-term change in treatment before it is implemented by the owner. Examples of long-term treatment changes include the addition of a new treatment process or modification of an existing treatment process. Examples of modification include switching secondary disinfectants, switching coagulants (e.g., alum to ferric chloride), or switching corrosion inhibitor products (e.g., orthophosphate to blended phosphate). Long-term changes can include dose changes to existing chemicals if the waterworks is planning long-term changes to its finished water pH or residual inhibitor concentration. Long-term treatment changes would not include chemical dose fluctuations associated with daily source water quality changes.

4. The owner of a small waterworks applying for a monitoring waiver under 12VAC5-590-375 B 7 or subject to a waiver granted pursuant to 12VAC5-590-375 B 7 c shall provide the following information to the department in writing by the specified deadline:

a. By the start of the first applicable monitoring period in 12VAC5-590-375 B 4, the owner of a small waterworks applying for a monitoring waiver shall provide the documentation required to demonstrate that the waiver criteria of 12VAC5-590-375 B 7 a and 12VAC5-590-375 B 7 b have been met.

b. No later than nine years after the monitoring previously conducted pursuant to 12VAC5-590-375 B 7 b or 12VAC5-590-375 B 7 d (1), the owner of a small waterworks desiring to maintain its monitoring waiver shall provide the information required by 12VAC5-590-375 B 7 d (1) and 12VAC5-590-375 B 7 d (2).

c. No later than 60 days after becoming aware that it is no longer free of lead-containing or copper-containing material, the owner of a small waterworks with a monitoring waiver shall provide written notification to the department setting forth the circumstances resulting in the lead-containing or copper-containing materials being introduced into the waterworks and what corrective action, if any, the owner plans to take to remove these materials.

5. The owner of a groundwater system that limits water quality parameter monitoring to a subset of entry points under 12VAC5-590-375 C 3 c shall provide by the commencement of the monitoring written correspondence to the department that identifies the selected entry points and includes information sufficient to demonstrate that the sites are representative of water quality and treatment conditions throughout the waterworks.

C. Source water monitoring reporting requirements.

1. The owner shall report the sampling results for all source water samples collected in accordance with 12VAC5-590-375 D within the first 10 days following the end of each source water monitoring period (i.e., annually, per compliance period, per compliance cycle) specified in 12VAC5-590-375 D.

2. With the exception of the first round of source water sampling conducted pursuant to 12VAC5-590-375 D 2, the owner shall specify any site that was not sampled during previous monitoring periods and include an explanation of why the sampling point has changed.

D. Corrosion control treatment reporting requirements. By the applicable dates under 12VAC5-590-405 A 2 a, an owner shall report the following information:

1. For the owner demonstrating that corrosion control has already been optimized, information required in 12VAC5-590-405 A 2 b (2) or 12VAC5-590-405 A 2 b (3).

2. For the owner required to optimize corrosion control, the owner's recommendation regarding optimal corrosion control treatment under 12VAC5-590-405 A 1 a.

3. For the owner required to evaluate the effectiveness of corrosion control treatments, the information required under 12VAC5-590-405 A 1 c.

4. For the owner required to install optimal corrosion control designated by the department under 12VAC5-590-405 A 1 d, a letter certifying that the owner has completed installing that treatment.

E. Source water treatment reporting requirements. By the applicable dates in 12VAC5-590-405 B, an owner shall provide the following information to the department:

1. If required under 12VAC5-590-405 B 2 a, the owner's recommendation regarding source water treatment; or

2. For an owner required to install source water treatment under 12VAC5-590-405 B 2 b, a letter certifying that the owner has completed installing the treatment designated by the department within 24 months after the department designated the treatment.

F. Lead service line replacement reporting requirements. The owner shall report the following information to the department to demonstrate compliance with the requirements of 12VAC5-590-405 C:

1. No later than 12 months after the end of a monitoring period in which a waterworks exceeds the lead AL in sampling referred to in 12VAC5-590-405 C 1, the owner shall submit written documentation to the department of the materials evaluation conducted as required in 12VAC5-590-375 B 1, to identify the initial number of lead service lines in the distribution system at the time the waterworks exceeds the lead AL, and provide the owner's schedule for annually replacing at least 7.0% of the initial number of lead service lines in its distribution system.

2. No later than 12 months after the end of a monitoring period in which a waterworks exceeds the lead AL in sampling referred to in 12VAC5-590-405 C 1, and every 12 months thereafter, the owner shall demonstrate to the department in writing that the owner has either:

a. Replaced in the previous 12 months at least 7.0% of the initial lead service lines or a greater number of lines specified by the department under 12VAC5-590-405 C 6 in the distribution system; or

b. Conducted sampling that demonstrates that the lead concentration in all service line samples from an individual line collected pursuant to 12VAC5-590-375 B 2 c is less than or equal to 0.015 mg/L. In these cases, the total number of lines replaced that meet the criteria in 12VAC5-590-405 C 4 shall equal at least 7.0% of the initial number of lead service lines identified under subdivision F 1 of this section or the percentage specified by the department under 12VAC5-590-405 C 6.

3. The annual letter submitted to the department under subdivision F 2 of this section shall contain the following information:

a. The number of lead service lines scheduled to be replaced during the previous year of the waterworks replacement schedule;

b. The number and location of each lead service line replaced during the previous year of the waterworks replacement schedule; and

c. If measured, the water lead concentration and location of each lead service line sampled, the sampling method, and the date of sampling.

4. The owner of a waterworks that collects lead service line samples following partial lead service line replacement required by 12VAC5-590-405 C shall report the results to the department within the first 10 days of the month following the month in which the owner receives the laboratory results or as specified by the department. The owner shall also report any additional information as specified by the department in a time and manner prescribed by the department to verify that all partial lead service line replacement activities have taken place.

G. Public education program reporting requirements. The owner shall report the following information to the department to demonstrate compliance with the requirements of 12VAC5-590-405 D.

1. The owner of a waterworks that is subject to the public education requirements in 12VAC5-590-405 D shall within 10 days after the end of each period in which the owner is required to perform public education tasks in accordance with 12VAC5-590-405 D 2 send written notice to the department that contains:

a. A demonstration that the owner has delivered the public education materials that meet the content requirements of 12VAC5-590-405 D 1 and the delivery requirements of 12VAC5-590-405 D 2; and

b. A list of all the newspapers, radio stations, television stations, and facilities and organizations to which the owner delivered public education materials during the period in which the owner was required to perform public education tasks.

2. Unless required by the department, an owner that previously has submitted the information required by subdivision G 1 b of this section need not resubmit the information required by subdivision G 1 b of this section, as long as there has been no changes in the distribution list and the owner certifies that the public education materials were distributed to the same list submitted previously.

3. No later than three months following the end of the monitoring period, the owner shall mail a sample copy of the consumer notification of tap results to the department along with a certification that the notification has been distributed in a manner consistent with the requirements of 12VAC5-590-405 D 4.

H. Reporting of additional monitoring data. The owner of a waterworks that collects sampling data in addition to that required by 12VAC5-590-375 shall report the results to the department within the first 10 days following the end of the applicable monitoring period under 12VAC5-590-375 B, 12VAC5-590-375 C, and 12VAC5-590-375 D during which the samples are collected.

I. Reporting of the 90th percentile lead and copper concentrations where the department calculates a waterworks' 90th percentile concentrations. The owner is not required to report the 90th percentile lead and copper concentrations measured from among all lead and copper tap samples collected during each monitoring period, as required by subdivision B 1 d of this section if:

1. The department has previously notified the owner that the department will calculate the waterworks' 90th percentile lead and copper concentrations based on the lead and copper tap results submitted pursuant to subdivision I 2 a of this section and has specified a date before the end of the applicable monitoring period by which the owner shall provide the results of the lead and copper tap water samples; and

2. The owner has provided the following information to the department by the date specified in subdivision I 1 of this section:

a. The results of all tap samples for lead and copper including the location of each site and the criteria under 12VAC5-590-375 B 1 c through 12VAC5-590-375 B 1 f or 12VAC5-590-375 B 1 g under which the site was selected for the waterworks sampling pool, pursuant to subdivision B 1 a of this section;

b. An identification of sampling sites utilized during the current monitoring period that were not sampled during the previous monitoring periods and an explanation why sampling sites have changed; and

c. The department has provided the results of the 90th percentile lead and copper calculations in writing to the owner before the end of the monitoring period.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-540 Public notices

A. The owner shall give public notice to (i) persons served by the waterworks and (ii) the owner of any consecutive waterworks to which it sells or otherwise provides water under the following circumstances.

1. Tier 1.

a. When E. coli are present in the distribution system, or when the waterworks fails to test for E. coli when any repeat sample tests positive for total coliform;

b. Violation of the PMCL for E. coli;

c. Violation of the PMCL for nitrate, nitrite, or total nitrate and nitrite;

d. Failure to collect a confirmation sample within 24 hours of the waterworks receipt of the first sample showing an exceedance of the nitrate or nitrite PMCL;

e. Exceedance of the nitrate PMCL by a noncommunity waterworks, where permitted to exceed the PMCL by the department;

f. Violation of the MRDL for chlorine dioxide when one or more samples collected in the distribution system the day following an exceedance of the MRDL at the entry point to the distribution system exceed the MRDL;

g. Failure to monitor chlorine dioxide residuals in the distribution system the day following an exceedance of the chlorine dioxide MRDL at the entrance to the distribution system;

h. Violation of the treatment technique requirements for filtration and disinfection resulting from a single exceedance of the maximum allowable turbidity limit, where the department determines after consultation that a Tier 1 notice is required;

i. Failure to consult with the department within 24 hours after the owner learns of the violation of the treatment technique requirements for filtration and disinfection resulting from a single exceedance of the maximum allowable turbidity limit;

j. Occurrence of a waterborne disease outbreak or other waterborne emergency (such as a failure or significant interruption in key water treatment processes, a natural disaster that disrupts the water supply or distribution system, or a chemical spill or unexpected loading of possible pathogens into the source water that significantly increases the potential for drinking water contamination);

k. Detection of E. coli in groundwater source samples; or

l. Other violations or situations with significant potential to have serious adverse effects on human health as a result of short-term exposure, as determined by the commissioner or department on a case-by-case basis.

2. Tier 2.

a. All violations of the PMCL, MRDL, and treatment technique requirements, except where a Tier 1 public notice is required or where the department determines that a Tier 1 notice is required instead per subdivision A 1 l of this section;

b. Violations of the monitoring and testing procedure requirements, where the department determines that a Tier 2 rather than a Tier 3 public notice is required instead, taking into account potential health impacts and persistence of the violation;

c. Failure to comply with the terms and conditions of any variance or exemption in place; or

d. Failure to take corrective action or failure to maintain at least 4-log treatment of viruses (using inactivation, removal, or an approved combination of 4-log virus inactivation and removal) before or at the first customer under the treatment technique requirements for waterworks with groundwater sources.

3. Tier 3.

a. Monitoring violations, except where a Tier 1 public notice is required per subdivisions A 1 d and A 1 g of this section, or where the department determines that a Tier 2 public notice is required instead per subdivision A 2 b of this section;

b. Failure to comply with a testing procedure, except where a Tier 1 notice is required per subdivision A 1 b of this section or where the department determines that a Tier 2 notice is required instead per subdivision A 2 b of this section;

c. Operation under a variance or an exemption to a PMCL or treatment technique requirement;

d. Availability of UC monitoring results; or

e. Exceedance of the fluoride SMCL.

4. The department may require public notice for violations or other situations not listed in this section or may require a higher tier of public notice for specific violations and situations listed in this section.

a. The content and extent of distribution of these public notices shall be determined by the department.

b. The owner shall provide the public notice certification required in subsection N of this section.

c. At least 90 days before initiating or discontinuing a program to provide the optimum fluoride ion concentration, a waterworks owner shall deliver written notice to the waterworks' consumers. Notice to consumers shall be consistent with 12VAC5-590-540 C 2 d.

B. If a waterworks has a violation, failure, exceedance, or situation in a portion of the distribution system that is physically or hydraulically isolated from other parts of the distribution system, the department may allow the owner to limit distribution of the public notice to only those persons served by the portion of the waterworks that is out of compliance. The decision granting limited distribution of the public notice shall be issued in writing.

C. Public notice distribution requirements.

1. For Tier 1 violations, exceedances, or situations, the owner shall:

a. Provide a public notice as soon as practical but no later than 24 hours after the owner learns of the violation, exceedance, or situation;

b. Initiate consultation with the department as soon as practical, but no later than 24 hours after the owner learns of the violation, exceedance, or situation, to determine additional public notice requirements;

c. Comply with any additional public notice requirements, including any repeat notices or direction on the duration of the posted notices that are established as a result of the consultation with the department. These requirements may include the timing, form, manner, frequency, and content of repeat notices (if any) and other actions designed to reach all persons served; and

d. Provide the public notice in a form and manner reasonably calculated to reach all persons served. The form and manner shall fit the specific situation, and shall be designed to reach residential, transient, and nontransient users of the waterworks. To reach all persons served, owners shall use, at a minimum, one or more of the following forms of delivery:

(1) Appropriate broadcast media (such as radio and television);

(2) Posting of the public notice in conspicuous locations throughout the area served by the waterworks;

(3) Hand delivery of the public notice to persons served by the waterworks; or

(4) Another delivery method approved in writing by the department.

2. For Tier 2 violations, exceedances, or situations, the owner shall:

a. Provide the public notice as soon as practical, but no later than 30 days after the owner learns of the violation, exceedance, or situation. The department may allow, on a case-by-case determination, additional time for the initial notice of up to three months from the date the owner learns of the violation, exceedance, or situation; however, the department shall not grant an extension to the 30-day deadline for any unresolved violation, exceedance, or situation.

b. Repeat the public notice every three months as long as the violation, exceedance, or situation persists, unless the department determines that appropriate circumstances warrant a different repeat notice frequency. In no circumstance shall the repeat notice be given less frequently than once per year. Repeat notice frequency less than every three months shall not be allowed for (i) a violation as specified in 12VAC5-590-380 B and 12VAC5-590-392 F; (ii) a treatment technique violation for filtration and disinfection; and (iii) other ongoing violations, exceedances, or situations.

c. Consult with the department as soon as practical but no later than 24 hours after the owner learns of a violation of the treatment technique requirements for filtration and disinfection resulting from a single exceedance of the maximum allowable turbidity limit to determine whether a Tier 1 public notice is required to protect public health. If consultation does not take place within the 24-hour period, then the owner shall distribute a Tier 1 public notice of the violation within the next 24 hours (i.e., no later than 48 hours after the owner learns of the violation).

d. Provide the initial public notice and any repeat notices in a form and manner that is reasonably calculated to reach persons served in the required time period.

(1) For a community waterworks, the owner shall:

(a) Mail or otherwise directly deliver the public notice to each customer receiving a bill and to other service connections to which water is delivered by the waterworks; and

(b) Use any other distribution method reasonably calculated to reach other persons regularly served by the waterworks, if they would not normally be reached by the notice required in subdivision C 2 d (1) (a) of this section. These persons may include those who do not pay water bills or do not have service connection addresses (e.g., house renters, apartment dwellers, university students, nursing home patients, prison inmates, etc.). Other methods may include (i) publication in a local newspaper; (ii) delivery of multiple copies for distribution by customers that provide their drinking water to others (e.g., apartment building owners or large private employers); (iii) posting in public places served by the waterworks or on the Internet; or (iv) delivery to community organizations.

(2) For a noncommunity waterworks, the owner shall:

(a) Post the public notice in conspicuous locations throughout the distribution system frequented by persons served by the waterworks, or by mail or direct delivery to each customer and service connection (where known); and

(b) Use any other method reasonably calculated to reach other persons served by the system if they would not normally be reached by the notice required in subdivision C 2 d (2) (a) of this section. These persons may include those served who may not see a posted notice because the posted notice is not in a location they routinely pass by. Other methods may include (i) publication in a local newspaper or newsletter distributed to customers; (ii) use of email to notify employees or students; or (iii) delivery of multiple copies in central locations (e.g., community centers).

e. Maintain a posted public notice in place for as long as the violation, exceedance, or situation persists, but in no case for less than seven days, even if the violation, exceedance, or situation is resolved.

3. For Tier 3 violations, exceedances, or situations the owner shall:

a. Provide the public notice not later than one year after the owner learns of the violation, exceedance, or situation or begins operating under a variance or exemption.

b. Repeat the public notice annually for as long as the violation, exceedance, variance, exemption, or other situation persists.

c. Maintain a posted public notice in place for as long as the violation, exceedance, variance, exemption, or other situation persists, but in no case less than seven days even if the violation, exceedance, or situation is resolved.

d. Instead of individual Tier 3 public notices, the owner may use an annual report detailing all violations, exceedances, and situations that occurred during the previous 12 months, as long as the timing requirements of subdivision C 3 a of this section are met. For a community waterworks, the CCR may be used as a vehicle for the initial Tier 3 public notice and all required repeat notices, provided that:

(1) The CCR is provided to persons served by the waterworks no later than 12 months after the owner learns of the violation, exceedance, or other situation.

(2) The Tier 3 public notice contained in the CCR meets the content requirements in subsection D of this section.

(3) The CCR is distributed in a manner meeting the delivery requirements in subdivision C 3 e (1) of this section.

e. For a community waterworks, the owner shall:

(1) Mail or otherwise directly deliver the public notice to each customer receiving a bill and to other service connections to which water is delivered by the waterworks; and

(2) Use any other method reasonably calculated to reach other persons regularly served by the waterworks if they would not normally be reached by the notice required in subdivision C 3 e (1) of this section. These persons may include those who do not pay water bills or do not have service connection addresses (e.g., house renters, apartment dwellers, university students, nursing home patients, prison inmates, etc.). Other methods may include (i) publication in a local newspaper, (ii) delivery of multiple copies for distribution by customers that provide their drinking water to others (e.g., apartment building owners or large private employers), (iii) posting in public places or on the Internet, or (iv) delivery to community organizations.

f. For a noncommunity waterworks the owner shall:

(1) Post the public notice in conspicuous locations throughout the distribution system frequented by persons served by the waterworks, or by mail or direct delivery to each customer and service connection (where known); and

(2) Use any other method reasonably calculated to reach other persons served by the waterworks, if they would not normally be reached by the notice required in subdivision C 3 f (1) of this section. These persons may include those who may not see a posted notice because the notice is not in a location they routinely pass by. Other methods may include (i) publication in a local newspaper or newsletter distributed to customers, (ii) use of email to notify employees or students, or (iii) delivery of multiple copies in central locations (e.g., community centers).

D. Public notice contents.

1. Each public notice for PMCL, MRDL, and TT violations and other situations requiring a public notice shall include the following elements:

a. A description of the violation, exceedance, or situation, including the contaminants of concern, and (as applicable) the contaminant levels;

b. When the violation, exceedance, or situation occurred;

c. Any potential adverse health effects from the violation, exceedance, or situation, including the standard language under subdivision 5 a or 5 b of this subsection, whichever is applicable;

d. The population at risk, including subpopulations particularly vulnerable if exposed to the contaminant in their drinking water;

e. Whether alternative water supplies should be used;

f. What actions consumers should take, including when they should seek medical help, if known;

g. What the owner is doing to correct the violation, exceedance, or situation;

h. When the owner expects the waterworks to return to compliance or resolve the situation;

i. The name, business address, and phone number of the owner, operator, or designee as a source of additional information concerning the notice; and

j. A statement to encourage the notice recipient to distribute the public notice to other persons served, using the standard language under subdivision 5 c of this subsection, where applicable.

2. Each public notice for a waterworks that has been granted a variance or exemption shall include the following elements:

a. An explanation of the reasons for the variance or exemption;

b. The date on which the variance or exemption was issued;

c. A brief status report on the steps the owner is taking to install treatment, find alternative sources of source water, or otherwise comply with the terms and schedules of the variance or exemption; and

d. A notice of any opportunity for public input in the evaluation of the variance or exemption.

3. Each public notice for a waterworks that violates the conditions of a variance or an exemption shall contain the 10 elements listed in subdivision D 1 of this section.

4. Each public notice shall:

a. Be displayed in a conspicuous way when printed or posted;

b. Not contain overly technical language or very small print;

c. Not be formatted in a way that defeats the purpose of the notice;

d. Not contain language that nullifies the purpose of the notice; and

e. Contain information in the appropriate languages, for waterworks serving a large proportion of non-English-speaking consumers, regarding the importance of the notice or contain a telephone number or address where persons served may contact the owner to obtain a translated copy of the notice or to request assistance in the appropriate language.

5. The public notice shall include the following standard language:

a. For PMCL or MRDL violations, treatment technique violations, and violations of the condition of a variance or an exemption, use standard health effects language as specified in 12VAC5-590-546 corresponding to each PMCL, MRDL, and treatment technique violation and for each violation of a condition of a variance or an exemption. For violation of the treatment technique requirement, the public notice shall also include one or both of the following statements, as appropriate:

(1) "We failed to conduct the required assessment."

(2) "We failed to correct all sanitary defects that were identified during the assessment."

b. For monitoring and testing procedure violations including failure to monitor for total coliform bacteria or E. coli before serving water from a seasonal waterworks, use standard language as specified below, including the language necessary to fill in the blanks:

"We are required to monitor your drinking water for specific contaminants on a regular basis. Results of regular monitoring are an indicator of whether or not your drinking water meets health standards. During (compliance period), we (did not monitor or test or did not complete all monitoring or testing) for (contaminants) and therefore cannot be sure of the quality of your drinking water during that time."

c. For all public notices, use standard language (where applicable), as specified in this subdivision c:

"Please share this information with all the other people who drink this water, especially those who may not have received this notice directly (e.g., people in apartments, nursing homes, schools, and businesses). You can do this by posting this notice in a public place or distributing copies by hand or mail."

d. For total coliform bacteria treatment technique violations the public notice shall include the following statement: "We found coliforms indicating the need to look for potential problems in our waterworks. When this occurs, we are required to conduct assessments to identify problems and correct any problems that are found." The public notice shall also include the following statements, as appropriate:

(1) "We failed to conduct the required assessment."

(2) "We failed to correct all sanitary defects that were identified during the assessment."

e. For E. coli treatment technique violations the public notice shall include the following statement: "We violated the standard for E. coli, indicating the need to look for potential problems in our waterworks. When this occurs, we are required to conduct a detailed assessment to identify problems and to correct any problems that are found." The public notice shall also include the following statements, as appropriate:

(1) "We failed to conduct the required assessment."

(2) "We failed to correct all sanitary defects that were identified during the assessment."

E. Public notice to new billing units or customers.

1. For a community waterworks, the owner shall give a copy of the most recent public notice for any continuing violation, exceedance, variance, exemption, or other ongoing situation requiring a public notice to all new billing units or new customers before or at the time service begins.

2. For a noncommunity waterworks, the owner shall continuously post the public notice in conspicuous locations to inform new consumers of any continuing violation, exceedance, variance, exemption, or other situation requiring a public notice for as long as the violation, exceedance, variance, exemption, or other situation persists.

F. Special notice of the availability of UC monitoring results.

1. The owner of a community waterworks or a NTNC shall notify persons served by the waterworks of the availability of the results of the sampling no later than 12 months after the monitoring results are known.

2. The special notice shall meet the requirements of a Tier 3 public notice and shall identify a person and telephone number to contact for information on the monitoring results.

G. Special notice for exceedance of the SMCL for fluoride.

1. A community waterworks that exceeds the SMCL of 2 mg/L but does not exceed the PMCL of 4 mg/L for fluoride shall provide public notice to persons served as soon as practical but no later than 12 months from the day the owner learns of the exceedance.

2. A copy of the notice shall be sent to all new billing units and new customers at the time service begins and to the department.

3. The owner shall repeat the notice at least annually for as long as the SMCL is exceeded.

4. If the public notice is posted, then the notice shall remain in place for as long as the SMCL is exceeded, but in no case less than seven days even if the exceedance is eliminated.

5. On a case-by-case basis, the department may require an initial notice sooner than 12 months and repeat notices more frequently than annually.

6. The form and manner of the public notice (including repeat notices) shall meet the requirements of a Tier 3 public notice.

7. The public notice shall contain the following language, including the language necessary to fill in the blanks:

"This is an alert about your drinking water and a cosmetic dental problem that might affect children under nine years of age. At low levels, fluoride can help prevent cavities, but children drinking water containing more than 2 milligrams per liter (mg/L) of fluoride may develop cosmetic discoloration of their permanent teeth (dental fluorosis). The drinking water provided by your community waterworks (name) has a fluoride concentration of (insert value) mg/L. Dental fluorosis, in its moderate or severe forms, may result in a brown staining and/or pitting of the permanent teeth. This problem occurs only in developing teeth, before they erupt from the gums. Children under nine should be provided with alternative sources of drinking water or water that has been treated to remove the excess fluoride to avoid the possibility of staining and pitting of their permanent teeth. You may also want to contact your dentist about proper use by young children of fluoride-containing products by young children. Older children and adults may safely drink the water. Drinking water containing more than 4 mg/L of fluoride (the U.S. Environmental Protection Agency's drinking water standard) can increase your risk of developing bone disease. Your drinking water does not contain more than 4 mg/L of fluoride, but we are required to notify you when we discover that the fluoride levels in your drinking water exceed 2 mg/L because of this cosmetic dental problem. For more information, please call (name of water system contact) of (name of community waterworks) at (phone number). Some home water treatment units are also available to remove fluoride from drinking water. To learn more about available home water treatment units, you may call NSF International at 1-877-867-3435 or email info@nsf.org."

H. Special notice for nitrate exceedances above PMCL by a noncommunity waterworks.

1. The owner of a noncommunity waterworks granted permission by the department to exceed the nitrate PMCL shall provide public notice to persons served meeting the requirements of a Tier 1 notice.

2. The public notice shall be posted continuously and shall indicate the fact that nitrate levels exceed 10 mg/L and the potential health effects of exposure, meeting the requirements of Tier 1 public notice delivery and content.

I. Special notice for repeated failure to conduct sampling of the source water for Cryptosporidium.

1. The owner who is required to sample source water shall provide public notice to persons served when the owner has failed to collect any three months of required samples. The form and manner of the public notice shall satisfy the requirements of a Tier 2 notice, and the notice shall be repeated in accordance with the requirements of a Tier 2 notice.

2. The notice shall contain the following language, including the language to fill in the blanks:

"We are required to monitor the source of your drinking water for Cryptosporidium. Results of the monitoring are to be used to determine whether water treatment at the (blank – fill in treatment plant name) is sufficient to adequately remove Cryptosporidium from your drinking water. We are required to complete this monitoring and make this determination by (blank – fill in required bin determination date) We "did not monitor" or "did not complete all monitoring or testing" on schedule and, therefore, we may not be able to determine by the required date what treatment modifications, if any, shall be made to ensure adequate Cryptosporidium removal. Missing this deadline may, in turn, jeopardize our ability to have the required treatment modifications, if any, completed by the deadline required, (blank – fill in date).

For more information, please call (blank – fill in name of waterworks contact) of (blank – fill in name of waterworks) at (blank – fill in phone number)."

3. The notice shall contain a description of what the owner is doing to correct the violation and when the owner expects the waterworks to return to compliance or resolve the situation.

J. Special notice for failure to determine bin classification or mean Cryptosporidium level.

1. The owner that is required to determine a bin classification or to determine mean Cryptosporidium level shall provide public notice to persons served when the determination has not been made as required. The form and manner of the public notice shall satisfy the requirements of a Tier 2 notice, and the notice shall be repeated in accordance with the requirements of a Tier 2 notice. However, a public notice is not required if the owner is complying with a schedule to address the violation approved by the department.

2. The notice shall contain the following language, including the language to fill in the blanks:

"We are required to monitor the source of your drinking water for Cryptosporidium in order to determine by [blank – fill in date] whether water treatment at the (blank – fill in treatment plant name) is sufficient to adequately remove Cryptosporidium from you drinking water. We have not made this determination by the required date. Our failure to do this may jeopardize our ability to have the required treatment modifications, if any, completed by the required deadline of (blank – fill in date). For more information, please call (blank – fill in name of waterworks contact) of (blank – fill in name of waterworks) at (blank – fill in telephone number)."

3. The notice shall contain a description of what the owner is doing to correct the violation and when the owner expects the waterworks to return to compliance or resolve the situation.

K. Special notice for significant deficiencies by a noncommunity groundwater system.

1. An owner of a noncommunity groundwater system that has not corrected a significant deficiency within one year of being notified by the department shall provide public notice to the consumers.

2. The form and manner of the public notice shall satisfy the requirements of a Tier 2 notice.

3. The owner shall continue to notify the public annually until the requirements of 12VAC5-590-421 have been satisfied. The notice shall include:

a. The nature of the significant deficiency and the date it was identified by the department; and

b. The department approved plan and schedule for correcting the significant deficiency including interim measures, progress to date, and which of the interim measures have been completed.

4. For a noncommunity groundwater system with a large proportion of non-English-speaking consumers, the notice shall contain information in the appropriate languages regarding the importance of the notice or contain a telephone number or address where the consumers may contact the owner to obtain a translated copy of the notice or assistance with the appropriate language.

5. If directed by the department, the owner of a noncommunity groundwater system with significant deficiencies that have been corrected shall inform the consumers of the significant deficiencies, how the deficiencies were corrected, and the date of correction.

L. The department may give notice to the public required by this section on behalf of the owner as long as the notice complies with the requirements of this section. However, the owner remains legally responsible for ensuring that the requirements of this section are met.

M. The department may require an owner to provide public notice for significant changes in water quality.

N. Within 10 days of completion of each initial and repeat public notice, the owner shall provide the department with the following:

1. A certification that the owner has fully complied with the public notice requirements; and

2. A representative copy of each type of notice that was distributed, published, posted, and made available to the persons served by the waterworks and to the media.

O. The owner shall maintain copies of each public notice and certification for at least three years after issuance.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-005.10 § 2.21, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 12, Issue 2, eff. November 15, 1995; Volume 18, Issue 19, eff. July 3, 2002; Volume 19, Issue 24, eff. September 10, 2003; Volume 21, Issue 13, eff. April 6, 2005; Volume 22, Issue 15, eff. May 3, 2006; Volume 25, Issue 5, eff. December 10, 2008; Volume 28, Issue 5, eff. December 7, 2011; Volume 33, Issue 3, eff. November 2, 2016; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-545 Consumer confidence reports

A. Purpose and applicability.

1. The owner of a community waterworks shall deliver to the owner's customers a report that contains information specified in this section and shall include a summary as specified in subsection I of this section.

2. For the purpose of this section, "customers" are defined as billing units or service connections to which water is delivered by a community waterworks. For the purposes of this section, "consumers"are defined as people served by the water system, including customers and people who do not receive a bill.

3. For the purpose of this section, "detected" means: at or above the levels prescribed by 40 CFR 141.23(a)(4) for inorganic contaminants, at or above the levels prescribed by 40 CFR 141.24(f)(7) and 40 CFR 141.24(h)(18) for the contaminants listed in Table 340.2, at or above the levels prescribed by 40 CFR 141.131(b)(2)(iv) for the contaminants or contaminant groups listed in Table 340.6, and at or above the levels prescribed by Table 378.1 for radioactive contaminants.

B. Effective dates.

1. The owner of an existing community waterworks shall deliver the report by July 1 annually. The report shall contain data collected during the previous calendar year or the most recent calendar year before the previous calendar year.

2. The owner of a new community waterworks shall deliver the first report by July 1 of the year after its first full calendar year in operation and annually thereafter.

3. The owner of a community waterworks that sells water to a consecutive waterworks shall deliver the applicable information necessary to comply with the requirements contained in this section to the consecutive waterworks by April 1, 2027, and annually thereafter or on a date mutually agreed upon by the seller and the purchaser and specifically included in a contract between the parties. A community waterworks that sells water to another community waterworks that is required to provide reports biannually according to subsection H of this section must provide the applicable information required in subsection H of this section by October 1, 2027, to the buyer waterworks, and annually thereafter or on a date mutually agreed upon by the seller and the purchaser, included in a contract between the parties.

C. Content.

1. The owner of a community waterworks shall provide the owner's customers a report that contains the information on the source of the water delivered and a summary as specified in subsection I of this section as follows:

a. The report shall identify the source of the water delivered by the community waterworks by providing information on:

(1) The type of the source water (e.g., surface water, groundwater); and

(2) The commonly used name, if any, and location of the body of the source water.

b. Where a source water assessment has been completed, the report shall:

(1) Notify consumers of the availability of the assessment;

(2) Include the year the assessment was completed or most recently updated;

(3) Describe the means to obtain the assessment; and

(4) Include a brief summary of the waterworks' susceptibility to potential sources of contamination.

c. The owner is encouraged to highlight in the report significant sources of contamination in the source water area if the information is readily available.

2. For the purpose of compliance with this section, the report shall include the following definitions:

a. "Maximum contaminant level goal" or "MCLG" means the level of a contaminant in drinking water below which there is no known or expected risk to health. MCLGs allow for a margin of safety.

b. "Maximum contaminant level" or "MCL" means the highest level of a contaminant that is allowed in drinking water. MCLs are set as close to the MCLGs as feasible using the best available treatment technology.

c. The report for a community waterworks operating under a variance or an exemption issued by the commissioner under 12VAC5-590-140 and 12VAC5-590-150 shall include the following definition: "Variances and exemptions" means state or EPA permission not to meet an MCL or a treatment technique under certain conditions.

d. The report that contains data on contaminants that EPA regulates using any of the following terms shall include the applicable definitions:

(1) "Treatment technique" means a required process intended to reduce the level of a contaminant in drinking water.

(2) "Action level" means the concentration of a contaminant that, if exceeded, triggers treatment or other requirements that an owner shall follow.

(3) "Maximum residual disinfectant level goal" or "MRDLG" means the level of a drinking water disinfectant below which there is no known or expected risk to health. MRDLGs do not reflect the benefits of the use of disinfectants to control microbial contaminants.

(4) "Maximum residual disinfectant level" or "MRDL" means the highest level of a disinfectant allowed in drinking water. There is convincing evidence that addition of a disinfectant is necessary for the control of microbial contaminants.

(5) "Level 1 assessment" means a study of the waterworks to identify potential problems and determine, if possible, why total coliform bacteria have been found in waterworks.

(6) "Level 2 assessment" means a very detailed study of the waterworks to identify potential problems and determine, if possible, why an E. coli PMCL violation has occurred and why total coliform bacteria have been found in waterworks on multiple occasions.

(7) "Pesticide" means, generally, any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest.

(8) "Herbicide" means any chemical used to control undesirable vegetation.

3. Information on detected contaminants.

a. This section specifies the requirements for information to be included in the report for contaminants subject to a PMCL, AL, MRDL, or treatment technique as specified in 12VAC5-590-340.

b. The data relating to these contaminants shall be presented in the reports in a manner that is clear and understandable for consumers. For example, the data may be displayed in one table or in several adjacent tables. Any additional monitoring results that an owner of a community waterworks chooses to include in the report shall be displayed separately.

c. The data shall be derived from data collected to comply with EPA and state monitoring and analytical requirements during the previous calendar year or the most recent calendar year before the previous calendar year, except that where an owner is allowed to monitor for contaminants specified in subdivision C 3 a of this section less often than once a year, the contaminant data section shall include the date and results of the most recent sampling, and the report shall include a brief statement indicating that the data presented in the report are from the most recent testing done in accordance with this chapter. No data older than five years need be included.

d. For each detected regulated contaminant subject to a PMCL, AL, MRDL, or treatment technique as listed in Tables 340.1 through 340.7 and 406.1, the contaminant data section shall contain:

(1) The PMCL for that contaminant expressed as a number equal to or greater than 1.0 as provided in 12VAC5-590-546;

(2) The MCLG for that contaminant expressed in the same units as the PMCL as provided in 12VAC5-590-546;

(3) If there is no PMCL for a detected contaminant, then the contaminant data section shall indicate that there is a treatment technique, or specify the AL, applicable to that contaminant, and the report shall include the definitions for treatment technique, AL, or both, as appropriate, specified in subdivision C 3 d of this section;

(4) For contaminants subject to a PMCL, except turbidity and E. coli, the contaminant data section shall contain the highest contaminant level used to determine compliance and the range of detected levels is as follows:

(a) When compliance with the PMCL is determined annually or less frequently, the highest detected level at any sampling point and the range of detected levels expressed in the same units as the PMCL.

(b) When compliance with the PMCL is determined by calculating an RAA of all samples collected at a sampling point, the highest average of any of the sampling points and the range of all sampling points expressed in the same units as the PMCL. For the PMCLs for TTHM and HAA5, the owner shall include the highest LRAA for TTHM and HAA5 and the range of individual sample results for all sampling points expressed in the same units as the PMCL. If more than one location exceeds the TTHM or HAA5 PMCL, then the owner shall include the LRAAs for all locations that exceed the PMCL.

(c) When compliance with the PMCL is determined on a system-wide basis by calculating an RAA of all samples at all sampling points, the average and range of detection expressed in the same units as the PMCL. The range of detection for TTHM and HAA5 shall include the individual sample results for the purpose of establishing the monitoring locations for EPA's "Stage 2 Disinfectants and Disinfection Byproducts Rule" initial distribution system evaluation.

(5) For turbidity, the highest single measurement and the lowest monthly percentage of combined filter samples meeting the turbidity limits specified in 12VAC5-590-395 A 2 b for the filtration technology being used. The report should include an explanation of the reasons for measuring turbidity;

(6) For lead and copper, the 90th percentile value of the most recent round of sampling, the number of sampling sites exceeding the AL, and the range of tap sampling results;

(7) For E. coli analytical results under 12VAC5-590-370, the total number of positive samples; and

(8) The likely source of the detected contaminants to the best of the owner's knowledge. Specific information regarding contaminants may be available in sanitary surveys and source water assessments and should be used when available to the owner. If the owner lacks specific information on the likely source, then the report shall include one or more of the typical sources for that contaminant listed in 12VAC5-590-546 that are most applicable to the system.

e. If the owner of a community waterworks distributes water to the owner's customers from multiple hydraulically independent distribution systems that are fed by different source waters, then:

(1) The contaminant data section shall contain a separate column for each service area and the report shall identify each separate distribution system; or

(2) The owner shall produce a separate report tailored to include data for each service area.

f. The detected contaminant data section shall clearly identify any data indicating violations of PMCLs, MRDLs, or treatment techniques, and the report shall contain a clear and readily understandable explanation of the violation, including:

(1) The length of the violation;

(2) The potential adverse health effects using the relevant language of 12VAC5-590-546; and

(3) Actions taken by the owner to address the violation.

g. For detected UCs for which monitoring is required, the reports must present the average and range at which the contaminant was detected. The report shall include a brief explanation of the reasons for monitoring for UCs, such as:

(1) UC monitoring helps EPA to determine where certain contaminants occur and whether EPA should consider regulating those contaminants in the future; or

(2) The report may use an alternative educational statement in the CCR if approved by the department.

h. For systems that exceeded the lead AL in 12VAC5-590-385 A, the detected contaminant data section shall clearly identify the exceedance if any corrective action has been required by the department during the monitoring period covered by the report. The report shall include a clear and readily understandable explanation of the exceedance, the steps consumers can take to reduce their exposure to lead in drinking water, and a description of any corrective actions the system has or will take to address the exceedance.

4. Information on Cryptosporidium, radon, and other contaminants:

a. If the owner has performed any monitoring for Cryptosporidium, which indicates that Cryptosporidium may be present in the source water or the finished water, then the report shall include:

(1) A summary of the results of the monitoring; and

(2) An explanation of the significance of the results.

b. If the owner has performed any monitoring for radon, which indicates that radon may be present in the finished water, then the report shall include:

(1) The results of the monitoring; and

(2) An explanation of the significance of the results.

c. If the owner has performed additional monitoring that indicates the presence of other contaminants in the finished water, then the report should include any results that may indicate a health concern, as determined by the commissioner or department. Detections above a proposed MCL or health advisory level may indicate possible health concerns. For these contaminants, the report should include:

(1) The results of the monitoring; and

(2) An explanation of the significance of the results noting the existence of a health advisory or a proposed regulation.

5. Compliance with other regulations. In addition to the requirements of subdivision C 3 f of this section, the report shall note any violation that occurred during the year covered by the report of a requirement listed in this subdivision 5 and include a clear and readily understandable explanation of the violation, any potential adverse health effects, and the steps the owner has taken to correct the violation:

a. Monitoring and reporting of compliance data;

b. Filtration and disinfection prescribed by 12VAC5-590-395. For an owner who has failed to install adequate filtration or disinfection equipment or processes or has had a failure of such equipment or processes that constitutes a violation, the report shall include the following language as part of the explanation of potential adverse health effects: "Inadequately treated water may contain disease-causing organisms. These organisms include bacteria, viruses, and parasites, which can cause symptoms such as nausea, cramps, diarrhea, and associated headaches";

c. Lead and copper control requirements prescribed by 12VAC5-590-375. For that fails to take one or more of the prescribed actions, the report shall include the applicable language of 12VAC5-590-546 for lead, copper, or both;

d. Treatment techniques for acrylamide and epichlorohydrin prescribed by 12VAC5-590-395 B. For an owner who violates the requirements of that section, the report shall include the relevant language from 12VAC5-590-546;

e. Recordkeeping of compliance data;

f. Special monitoring requirements for sodium; and

g. Violation of the terms of a variance, an exemption, or an administrative or judicial order.

6. Variances and exemptions. If a waterworks is operating under the terms of a variance or an exemption issued by the commissioner under 12VAC5-590-140 and 12VAC5-590-150, then the report shall contain:

a. An explanation of the reasons for the variance or exemption;

b. The date on which the variance or exemption was issued;

c. A brief status report on the steps the owner is taking to install treatment, find alternative sources of source water, or otherwise comply with the terms and schedules of the variance or exemption; and

d. A notice of any opportunity for public input in the evaluation or renewal of the variance or exemption.

7. Additional information.

a. The report shall contain a brief explanation regarding contaminants, which may reasonably be expected to be found in drinking water, including bottled water. This explanation shall include the exact language of subdivisions 7 a (1), 7 a (2), and 7 a (3) of this subsection or the owner shall use comparable language following approval by the department. The report also shall include the exact language of subdivision 7 a (4) of this subsection.

(1) Both tap water and bottled water come from rivers, lakes, streams, ponds, reservoirs, springs, and wells. As water travels over the surface of the land or through the ground, it dissolves naturally occurring minerals, and in some cases, radioactive material, and can pick up and transport substances resulting from the presence of animals or from human activity. These substances are also called contaminants.

(2) Contaminants are any physical, chemical, biological, or radiological substance or matter in water. Contaminants that may be present in source water include:

(a)microbial contaminants, such as viruses and bacteria, which may come from sewage treatment plants, septic systems, agricultural livestock operations, and wildlife;

(b) inorganic contaminants, such as salts and metals, which can occur naturally in the soil or groundwater or may result from urban stormwater runoff, industrial or domestic wastewater discharges, oil and gas production, mining, or farming;

(c) pesticides and herbicides, which may come from a variety of sources, such as agriculture, urban stormwater runoff, and residential uses;

(d) organic chemical contaminants, including SOCs and VOCs, which are byproducts of industrial processes and petroleum production, and can also come from gas stations, urban stormwater runoff, and septic systems; and

(e) radioactive contaminants, which can occur naturally or be the result of oil and gas production and mining activities.

(3) To protect public health, EPA prescribes regulations that limit the amount of certain contaminants in tap water provided by waterworks. The U.S. Food and Drug Administration (FDA) regulations establish limits for contaminants in bottled water, which must provide the same protection for public health.

(4) Drinking water, including bottled water, may reasonably be expected to contain at least small amounts of some contaminants. The presence of contaminants does not necessarily indicate that water poses a health risk. More information about contaminants and potential health effects can be obtained by calling EPA's Safe Drinking Water Hotline (800-426-4791) or visiting EPA's website, epa.gov/safewater.

b. The report shall include the telephone number of the owner, operator, or designee of the community waterworks as a source of additional information concerning the report. If the waterworks uses a website or social media to share additional information, the department recommends including information in the report about how to access those media platforms.

c. In communities with a large proportion of consumers with limited English proficiency, as determined by the department, the report shall contain information in the appropriate languages regarding the importance of the report and either information where such consumers may obtain a translated copy of the report or assistance in the appropriate language, or the report shall be in the appropriate language.

d. The report shall include the following information about opportunities for public participation in decisions that may affect the quality of the drinking water. The owner should consider including the following additional relevant information:

(1) The time and place of regularly scheduled board meetings of the governing body that has authority over the waterworks; and

(2) If regularly scheduled board meetings are not held, then the name and telephone number of a waterworks representative who has operational or managerial authority over the waterworks.

e. The owner may include additional information as deemed necessary for public education consistent with, and not detracting from, the purpose of the report.

f. For a community groundwater system:

(1) Where there is a significant deficiency that is uncorrected at the time of the report or a fecal indicator-positive source water sample that is not invalidated in accordance with 12VAC5-590-380 at the time of the report, the owner shall report the following:

(a) The nature of the significant deficiency or the source if the source is known, of the fecal contamination;

(b) The date the significant deficiency was identified by the department or the dates of the fecal indicator-positive source water samples;

(c) Whether the fecal contamination has been addressed in accordance with 12VAC5-590-421 and the date of the action;

(d) For each significant deficiency or fecal contamination in the groundwater source that has not been addressed under 12VAC5-590-421, the department-approved plan and schedule, including interim measures, progress to date, and which interim measures for correcting the significant deficiency or fecal contamination have been completed; and

(e) If the waterworks receives notice of a fecal indicator-positive source water sample that is not invalidated in accordance with 12VAC5-590-380 using the health effects language 12VAC5-590-546 B.

(2) If directed by the department, where there are significant deficiencies that have been corrected at the time of the report, then the owner shall report the significant deficiencies, how the deficiencies were corrected, and the dates of correction.

D. Additional health information.

1. All reports shall prominently display the following language: "Some people may be more vulnerable to contaminants in drinking water than the general population. Immuno-compromised persons such as persons with cancer who are undergoing chemotherapy, persons who have undergone organ transplants, people with HIV/AIDS or other immune system disorders, some elderly, and infants can be particularly at risk from infections. These people should seek advice about drinking water from their health care providers. EPA and Centers for Disease Control and Prevention guidelines on appropriate means to lessen the risk of infection by Cryptosporidium and other microbial contaminants are available from the Safe Drinking Water Hotline (800-426-4791) or on EPA's website epa.gov/safewater."

2. The owner that detects arsenic at levels above 0.005 mg/L, but equal to or below the PMCL of 0.010 mg/L, shall include in the report the following informational statement about arsenic: "Arsenic is known to cause cancer in humans. Arsenic also may cause other health effects such as skin damage and circulatory problems. (Name of waterworks) meets the EPA arsenic drinking water standard, also known as a Maximum Contaminant Level (MCL). However, you should know that EPA's MCL for arsenic balances the scientific community's understanding of arsenic-related health effects and the cost of removing arsenic from drinking water. The highest concentration of arsenic found in (year) was (insert max arsenic level per 12VAC5-590-340) ppb."

Instead of the statement required in this subdivision, the owner may include the owner's educational statement after receiving approval from the department.

3. The owner that detects nitrate at levels above five mg/L, but below the PMCL, shall include in the report the following informational statement about the impacts of nitrate on children: "Even though (name of waterworks) meets the EPA nitrate drinking water standard, also known as a Maximum Contaminant Level (MCL), if you are caring for an infant and using tap water to prepare formula, you may want to use alternate sources of water or ask for advice from your health care provider. Nitrate levels above 10 ppm pose a particularly high health concern for infants younger than six months of age and can interfere with the capacity of the infant's blood to carry oxygen, resulting in a serious illness. Symptoms of serious illness include shortness of breath and blueness of the skin, known as "blue baby syndrome." Nitrate levels in drinking water can increase for short periods of time due to high levels of rainfall or agricultural activity, therefore we test for nitrate (insert applicable sampling frequency). The highest level for nitrate found during (year) was (insert max nitrate level per 12VAC5-590-340) ppm."

Instead of the statement required in this subdivision, the owner may include the owner's own educational statement after receiving approval from the department.

4. All reports shall prominently display the following lead-specific information: "Lead can cause serious health problems, especially for pregnant women and young children. Lead in drinking water is primarily from materials and components associated with service lines and home plumbing. (Name of waterworks) is responsible for providing high-quality drinking water and removing lead pipes, but cannot control the variety of materials used in plumbing components in your home. You share the responsibility for protecting yourself and your family from the lead in your home plumbing. You can take responsibility by identifying and removing lead materials within your home plumbing and taking steps to reduce your family's risk. Before drinking tap water, flush your pipes for several minutes by running your tap, taking a shower, or doing laundry or a load of dishes. You can also use a filter certified by an American National Standards Institute accredited certifier to reduce lead in drinking water. If you are concerned about lead in your water and wish to have your water tested, contact (name of waterworks and contact information). Information on lead in drinking water, testing methods, and steps you can take to minimize exposure is available at http://www.epa.gov/safewater/lead."

Instead of the statement required in this subdivision, the owner may include the owner's educational statement after receiving approval from the department.

E. The owner of a community waterworks required to complete a Level 1 or a Level 2 assessment that is not due to an E. coli PMCL violation shall include in the report the text specified in subdivisions E 1, E 2, and E 3 of this section as appropriate, filling in the blanks accordingly, and shall include in the report the text specified in subdivision E 4 of this section, if appropriate.

1. "Coliforms are bacteria that are naturally present in the environment and are used as an indicator that other, potentially harmful, waterborne pathogens may be present or that a potential pathway exists through which contamination may enter the drinking water distribution system. We found coliforms indicating the need to look for potential problems in water treatment or distribution. When this occurs, we are required to conduct assessments to identify problems and to correct any problems that are found."

2. "Because we found coliforms during sampling, we were required to conduct (insert the number of Level 1 assessments) Level 1 assessments to identify possible sources of contamination. (insert the number of Level 1 assessments) Level 1 assessments were completed. In addition, we were required to take (insert the number of corrective actions) corrective actions and we completed (insert the number of corrective actions) of these actions."

3. "Because we found coliforms during sampling, we were required to conduct (insert the number of Level 2 assessments) Level 2 detailed assessments to identify possible sources of contamination. (insert the number of Level 2 assessments) Level 2 assessments were completed. In addition, we were required to take (insert the number of corrective actions) corrective actions and we completed (insert the number of corrective actions) of these actions."

4. An owner that failed to complete all of the required assessments or correct all identified sanitary defects is in violation of the treatment technique requirement and shall also include one or both of the following statements, as appropriate:

a. "During the past year, we failed to conduct all of the required assessments."

b. "During the past year, we failed to correct all identified sanitary defects that were found during the assessments."

F. The owner of a community waterworks required to conduct Level 2 assessments due to an E. coli PMCL violation shall include in the report the text specified in subdivisions F 1 and F 2 of this section, filling in the blanks accordingly, and shall include in the report the text specified in subdivision F 3 of this section, if appropriate. An owner may use an alternative statement with equivalent information for subdivisions 1, 2, and 3 of this subsection if approved by the department.

1. "We found E. coli bacteria, indicating the need to look for potential problems in water treatment or distribution. When this occurs, we are required to conduct assessments to identify problems and to correct any problems that were found during those assessments."

2. "We were required to complete a Level 2 assessment because we found E. coli in our waterworks. In addition, we were required to take (insert number of corrective actions) corrective actions and we completed (insert number of corrective actions) of these actions."

3. Any owner that has failed to complete the required assessment or correct all identified sanitary defects is in violation of the treatment technique requirement and shall also include one or both of the following statements, as appropriate:

a. "We failed to conduct the required assessment."

b. "We failed to correct all sanitary defects that were identified during the assessment that we conducted."

4. If E. coli is detected in a waterworks and the E. coli PMCL is violated, in addition to completing the table as specified in subdivision C 3 d of this section, the owner shall include one or more of the following statements to describe any noncompliance, as applicable:

a. "We had an E. coli-positive repeat sample following a total coliform-positive routine sample."

b. "We had a total coliform-positive repeat sample following an E. coli-positive routine sample."

c. "We failed to collect all the required repeat samples following an E. coli-positive routine sample."

d. "We failed to test for E. coli when any repeat sample tested positive for total coliform."

5. If E. coli is detected in a waterworks and the E. coli PMCL is not violated, in addition to completing the table as specified in subdivision C 3 d of this section, the owner may include a statement that explains that although E. coli was detected, the owner is not in violation of the E. coli PMCL.

G. Waterworks required to comply with lead and copper control. Effective July 1, 2027:

1. The report shall notify consumers that complete lead tap sampling data are available for review and shall include information on how to access the data.

2. The report shall include a statement that a service line inventory (including inventories consisting only of a statement that there are no lead, galvanized requiring replacement, or lead status unknown service lines) has been prepared and include instructions to access the publicly available service line inventory. If the service line inventory is available online, the report must include the direct link to the inventory.

3. The report shall contain a plainly worded explanation of the corrosion control efforts the system is taking in accordance with 12VAC5-590-375 and 12VAC5-590-405. Corrosion control efforts consist of treatment (e.g., pH adjustment, alkalinity adjustment, or corrosion inhibitor addition) and other efforts contributing to the control of the corrosivity of water, including monitoring to assess the corrosivity of water. The owner may use one of the following templates or use an explanation that includes equivalent information.

a. For a waterworks with department or EPA-designated Optimal Corrosion Control Treatment:

(1) "Corrosion of pipes, plumbing fittings, and fixtures may cause lead and copper to enter drinking water. To assess corrosion of lead and copper, (name of waterworks) conducts tap sampling for lead and copper at selected sites (insert frequency at which system conducts tap sampling). (Name of waterworks) treats water using (identify treatment method) to control corrosion, which was designated as the optimal corrosion control treatment by (the state or EPA, as applicable). To ensure the treatment is operating effectively, (name of waterworks) monitors water quality parameters set by the (state or EPA, as applicable) (insert frequency at which waterworks conducts water quality parameter monitoring)."

(2) If applicable add: "(Name of waterworks) is currently conducting a study of corrosion control to determine if any changes to treatment methods are needed to minimize the corrosivity of the water."

b. For a waterworks without state or EPA designated Optimal Corrosion Control Treatment:

(1) "Corrosion of pipes, plumbing fittings and fixtures may cause metals, including lead and copper, to enter drinking water. To assess corrosion of lead and copper, (name of system) conducts tap sampling for lead and copper at selected sites (insert frequency at which waterworks conducts tap sampling)."

(2) If applicable, add: "(Name of waterworks) treats water using (identify treatment method) to control corrosion."

(3) If applicable add: "(Name of waterworks) is currently conducting a study of corrosion control to determine if any changes to treatment methods are needed to minimize the corrosivity of the water."

H. Report delivery, reporting, and recordkeeping.

1. Except as provided in subdivision 7 of this subsection, the owner of a community waterworks shall directly deliver one copy of the report to each customer.

a. An owner shall use, at a minimum, one of the following forms of delivery:

(1) Mail or hand deliver a paper copy of the report;

(2) Mail a notification that the report is available on a website via a direct link;

(3) Email a direct link or electronic version of the report; or

(4) Use another direct delivery method approved in writing by the department.

b. An owner using electronic delivery methods in subdivisions 1 a (2), 1 a (3), and 1 a (4) of this subsection shall provide a copy of the report to any customer upon request. The notification method must prominently display directions for requesting a copy of the report.

c. An owner that chooses to electronically deliver a report by posting the report to a website and providing a notification either by mail or email:

(1) Shall make the report publicly available on the website at the time the notification is made;

(2) Shall prominently display the link and include an explanation of the nature of the link; and

(3) May use a web page to convey the information required in this section.

d. An owner that uses a publicly available website to provide a report must maintain public access to the report for no fewer than three years.

2. The owner of a community waterworks shall make a good faith effort to reach consumers who do not receive water bills, such as renters or workers, using means recommended by the department. This good faith effort shall include a mix of the following methods to reach the broadest range of persons served by the waterworks:

a. Posting the reports on the Internet;

b. Mailing the report or postcard with a link to the report to all service addresses or postal customers;

c. Advertising the availability of the report in the news media;

d. Publishing in a local newspaper or newsletter;

e. Posting a copy of the report or notice of availability with links or equivalents, such as quick response (QR) codes, in public places such as cafeterias or lunchrooms of public buildings;

f. Delivering multiple copies for distribution by single-biller customers such as apartment buildings or large private employers;

g. Delivering to community organizations;

h. Using an opt-in notification system to send emails or texts with links to the reports to interested consumers;

j. Holding a public meeting to educate consumers on the reports; and

i. Other methods as approved by the department.

Where the owner is aware that the waterworks serves a substantial number of non-bill paying customers, the owner is encouraged to directly deliver the reports or notices of availability of the reports to service addresses. Where the owner is aware of a substantial number of bill-paying consumers without access to electronic forms of the report, the owner should use at least one non-electronic form of delivery.

3. No later than 10 days after the date the owner is required to distribute the report to waterworks customers, the owner of a community waterworks shall provide a copy of the report to the department and a certification that the report has been distributed to customers and that the information in the report is correct and consistent with the compliance monitoring data previously submitted to the department.

4. No later than the date the owner is required to distribute the report to its customers, the owner of a community waterworks shall deliver the report to any other agency or clearinghouse identified by the department.

5. The owner of a community waterworks shall make its reports available to the public upon request. The owner should make a reasonable effort to provide the reports in an accessible format to anyone who requests an accommodation.

6. The owner of a community waterworks serving 50,000 or more persons shall post the waterworks' current year's report to a publicly accessible site on the Internet.

7. The Governor or the Governor's designee can waive the requirement of subdivision 1 of this subsection for community waterworks serving fewer than 10,000 persons.

a. The owner of such a waterworks shall:

(1) Publish the reports in one or more local newspapers or on one or more local online news sites serving the area in which the system is located;

(2) Inform the customers that the reports will not be mailed, either in the newspapers in which the reports are published or by other means approved by the department; and

(3) Make the reports available to the public upon request.

b. The owner of a waterworks serving 500 or fewer persons may forgo the requirements of subdivisions 7 a (1) and 7 a (2) of this subsection if the owner provides notice that the report is available upon request at least once per year to the customers by mail, door-to-door delivery, or by posting in one or more locations where persons served by the waterworks can reasonably be expected to see it.

8. The owner of a community waterworks shall retain copies of the report for no fewer than three years.

9. The owner of a waterworks serving 100,000 or more persons shall develop a plan for providing assistance to consumers with limited English proficiency. The owner shall evaluate the languages spoken by persons with limited English proficiency served by the waterworks and the owner's anticipated approach to address translation needs. The owner shall provide the first plan to the department with the first report in 2027. Plans shall be evaluated annually and updated as necessary and reported with the certification required in subdivision 3 of this subsection.

10. Delivery timing and biannual delivery:

a. Each owner of a community waterworks shall distribute reports by July 1 each year. Each report distributed by July 1 shall use data collected during, or prior to, the previous calendar year using methods described in subdivision 1 of this subsection.

b. Beginning January 1, 2027, each owner of a community waterworks serving 10,000 or more persons shall distribute the report biannually, or twice per calendar year, by December 31 using methods described in subsection 1 of this section.

c. Beginning January 1, 2027, an owner required to comply with subdivision 10 b of this subsection with a violation or action level exceedance that occurred between January 1 and June 30 of the current year or that has received monitoring results from required monitoring under the Unregulated Contaminant Monitoring Rule in 40 CFR 141.40 shall include a six-month update with the second report with the following:

(1) A short description of the nature of the six-month update and the biannual delivery.

(2) If a waterworks receives an MCL, MRDL, or treatment technique violation, the six-month update shall include the applicable contaminant section information in subdivision C 4 of this section and a readily understandable explanation of the violation, including: the length of the violation, the potential adverse health effects, actions taken by the system to address the violation, and timeframe the waterworks expects to complete those actions. To describe the potential health effects, the owner must use the relevant language of 12VAC5-590-546 B.

(3) If a waterworks receives any other violation, the six-month update shall include the information in subdivision C 6 of this section.

(4) If a waterworks exceeded the lead action level following monitoring conducted between January 1 and June 30 of the current year, the owner shall include information identified in subdivisions C 4 d (4) and C 8 of this section.

(5) For a waterworks monitoring under the Unregulated Contaminant Monitoring Rule in 40 CFR 141.40 that becomes aware of results for samples collected during the reporting year that were not included in the reports distributed by July 1, the owner shall include information as required by subdivision C 4 e of this section.

I. Summary of report contents.

1. Each report shall include a summary displayed prominently at the beginning of the report, including a brief description of the nature of the report.

2. The owner shall include, at a minimum, the following information in the summary:

a. Summary of violations and compliance information included in the report required by subdivision C 6 of this section, 12VAC5-590-379 for groundwater systems, and 12VAC5-590-380.

b. Contact information for owner, operator, or designee of the community waterworks as a source of additional information concerning the report pursuant to subdivision C 7 b of this section.

3. If applicable, the owner of a waterworks shall include the following in the summary:

a. For a waterworks using delivery methods in subdivision H 1 a of this section, directions for consumers to request a paper copy of the report, as described in subdivision 2 b of this subsection.

b. For a waterworks subject to subdivision H 9 of this section because it serves a large proportion of consumers with limited English proficiency, information where consumers may obtain a translated copy of the report or get assistance in the appropriate language.

c. For a waterworks using the report to also meet the public notification requirements of 12VAC5-590-540, specify that the waterworks is also serving to provide public notification of one or more violations or situations and provide a brief statement about the nature of the notice and a brief description of how to locate the notice in the report.

4. The summary should be written in plain language and may use infographics.

5. For a waterworks required to include a six-month update with the second report under subdivision H 10 of this section, the summary should include a brief description of the nature of the report and update, noting the availability of new information for the current year (between January and June).

6. The report summary shall include the following standard language to encourage the distribution of the report to all persons served: "Please share this information with anyone who drinks this water (or their guardians), especially those who may not have received this report directly (for example, people in apartments, nursing homes, schools, and businesses). You can do this by posting this report in a public place or distributing copies by hand, mail, email, or another method."

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 21, eff. August 3, 2000; amended, Virginia Register Volume 22, Issue 24, eff. September 6, 2006; Volume 25, Issue 5, eff. December 10, 2008; Volume 27, Issue 1, eff. October 13, 2010; Volume 28, Issue 5, eff. December 7, 2011; Volume 28, Issue 11, eff. March 1, 2012; Volume 33, Issue 3, eff. November 2, 2016; Volume 37, Issue 20, eff. June 23, 2021; Errata, 37:22 VA.R. 3448 June 21, 2021; amended, Virginia Register Volume 43, Issue 1, eff. September 23, 2026; Errata, 43:5 VA.R. 555 October 19, 2026.

12VAC5-590-546 Regulated contaminants for the consumer confidence reports and public notification

A. Public notices and CCRs shall contain the appropriate mandatory language and information listed, as required by 12VAC5-590-540 and 12VAC5-590-545.

B. Information on regulated contaminants is presented in Table 546.1.

| TABLE 546.1 Content Requirements of Consumer Confidence Reports and Public Notices | | | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | CONTAMINANT (UNITS) | TRADITIONAL PMCL IN mg/l | TO CONVERT FOR CCR, MULTIPLY BY | PMCL IN CCR UNITS | MCLG | MAJOR SOURCES IN DRINKING WATER | HEALTH EFFECTS LANGUAGE | | | | | | | Microbiological Contaminants | | | | | | | | | | | | | (1) Total Coliform Bacteria | TT | n/a | Naturally present in the environment | Coliforms are bacteria that are naturally present in the environment and are used as an indicator that other, potentially-harmful, waterborne pathogens may be present or that a potential pathway exists through which contamination may enter the waterworks. | | | | | | | | | (2) E. coli | PMCL: In compliance unless (i) the waterworks has an E. coli-positive repeat sample following a total coliform-positive routine sample; (ii) the waterworks has a total coliform-positive repeat sample following an E. coli-positive routine sample; (iii) the waterworks owner fails to collect all required repeat samples following an E. coli positive routine sample; or (iv) the waterworks owner fails to test for E. coli when any repeat sample tests positive for total coliform. | 0 | Human and animal fecal waste | E. coli are bacteria whose presence indicates that the water may be contaminated with human or animal wastes. Human pathogens in these wastes can cause short-term effects, such as diarrhea, cramps, nausea, headaches, or other symptoms. They may pose a greater health risk for infants, young children, the elderly, and people with severely-compromised immune systems. | | | | | | | | | (3) E. coli | TT | n/a | Human and animal fecal waste | E. coli are bacteria whose presence indicates that the water may be contaminated with human or animal wastes. Human pathogens in these wastes can cause short-term health effects, such as diarrhea, cramps, nausea, headaches, or other symptoms. They may pose a greater health risk for infants, young children, the elderly, and people with severely compromised immune system. | | | | | | | | | (4) Source water fecal indicator (E. coli) | TT | | TT | 0 for E. coli | | Fecal indicators are microbes whose presence indicates that the water may be contaminated with human or animal wastes. Microbes in these wastes can cause short term health effects, such as diarrhea, cramps, nausea, headaches, or other symptoms. They may pose a special health risk for infants, young children, some of the elderly, and people with severely compromised immune system. | | | | | | | (5) Groundwater rule TT violations other than source water fecal indicator E. coli above^a | TT | | | TT | | Inadequately treated or inadequately protected water may contain disease-causing organisms. These organisms can cause symptoms such as diarrhea, nausea, cramps, and associated headaches. | | | | | | | (6)Turbidity | TT | | TT | n/a | Soil runoff | Turbidity has no health effects. However, turbidity can interfere with disinfection and provide a medium for microbial growth. Turbidity may indicate the presence of disease-causing organisms. These organisms include bacteria, viruses, and parasites that can cause symptoms such as nausea, cramps, diarrhea, and associated headaches. | | | | | | | (7) Giardia lamblia, viruses, Hetrotropic plate count, Legionella, Cryptosporidium^a | TT^c | | n/a | 0 | n/a | Inadequately treated water may contain disease-causing organisms. These organisms include bacteria, viruses, and parasites that can cause symptoms such as nausea, cramps, diarrhea, and associated headaches. | | | | | | | Radioactive Contaminants | | | | | | | | | | | | | (8) Beta/photon emitters (mrem/yr) | 4 mrem/yr | | 4 | 0 | Decay of natural and man-made deposits | Certain minerals are radioactive and may emit forms of radiation known as photons and beta radiation. Some people who drink water containing beta and photon emitters in excess of the PMCL over many years may have an increased risk of getting cancer. | | | | | | | (9) Alpha emitters (pCi/L) | 15 pCi/L | | 15 | 0 | Erosion of natural deposits | Certain minerals are radioactive and may emit a form of radiation known as alpha radiation. Some people who drink water containing alpha emitters in excess of the PMCL over many years may have an increased risk of getting cancer. | | | | | | | (10) Combined radium (pCi/L) | 5 pCi/L | | 5 | 0 | Erosion of natural deposits | Some people who drink water containing radium-226 or radium-228 in excess of the PMCL over many years may have an increased risk of getting cancer. | | | | | | | (11) Uranium (ppb) | 30 μg/L | | 30 | 0 | Erosion of natural deposits | Some people who drink water containing uranium in excess of the PMCL over many years may have an increased risk of getting cancer and kidney toxicity. | | | | | | | Inorganic Contaminants | | | | | | | | | | | | | (12) Antimony (ppb) | 0.006 | 1000 | 6 | 6 | Discharge from petroleum refineries; fire retardants; ceramics; electronics; solder | Some people who drink water containing antimony well in excess of the PMCL over many years could experience increases in blood cholesterol and decreases in blood sugar. | | | | | | | (13) Arsenic (ppb) | 0.010 | 1000 | 10. | 0 | Erosion of natural deposits; Runoff from orchards; Runoff from glass and electronics production wastes | Some people who drink water containing arsenic in excess of the PMCL over many years could experience skin damage or problems with their circulatory system, and may have an increased risk of getting cancer. | | | | | | | (14) Asbestos (MFL) | 7 MFL | | 7 | 7 | Decay of asbestos cement water mains; Erosion of natural deposits | Some people who drink water containing asbestos in excess of the PMCL over many years may have an increased risk of developing benign intestinal polyps. | | | | | | | (15) Barium (ppm) | 2 | | 2 | 2 | Discharge of drilling wastes; Discharge from metal refineries; Erosion of natural deposits | Some people who drink water containing barium in excess of the PMCL over many years could experience an increase in their blood pressure. | | | | | | | (16) Beryllium (ppb) | 0.004 | 1000 | 4 | 4 | Discharge from metal refineries and coal-burning factories; Discharge from electrical, aerospace, and defense industries | Some people who drink water containing beryllium well in excess of the PMCL over many years could develop intestinal lesions. | | | | | | | (17) Cadmium (ppb) | 0.005 | 1000 | 5 | 5 | Corrosion of galvanized pipes; Erosion of natural deposits; Discharge from metal refineries; Runoff from waste batteries and paints | Some people who drink water containing cadmium in excess of the PMCL over many years could experience kidney damage. | | | | | | | (18) Chromium (ppb) | 0.1 | 1000 | 100 | 100 | Discharge from steel and pulp mills; Erosion of natural deposits | Some people who drink water containing chromium well in excess of the PMCL over many years could experience allergic dermatitis. | | | | | | | (19) Copper (ppm) | AL=1.3 | | AL=1.3 | 1.3 | Corrosion of household plumbing systems; Erosion of natural deposits | Copper is an essential nutrient, but some people who drink water containing copper in excess of the AL over a relatively short amount of time could experience gastrointestinal distress. Some people who drink water containing copper in excess of the action level over many years could suffer liver or kidney damage. People with Wilson's Disease should consult their personal doctor. | | | | | | | (20) Cyanide (ppb) | 0.2 | 1000 | 200 | 200 | Discharge from steel or metal factories; Discharge from plastic and fertilizer factories | Some people who drink water containing cyanide well in excess of the PMCL over many years could experience nerve damage or problems with their thyroid. | | | | | | | (21) Fluoride (ppm) | 4 | | 4 | 4 | Erosion of natural deposits; Water additive that promotes strong teeth; Discharge from fertilizer and aluminum factories | Some people who drink water containing fluoride in excess of the PMCL over many years could get bone disease, including pain and tenderness of the bones. Fluoride in drinking water at half the PMCL or more may cause mottling of children's teeth, usually in children less than nine years old. Mottling, also known as dental fluorosis, may include brown staining or pitting of the teeth, and occurs only in developing teeth before they erupt from the gums. | | | | | | | (22) Lead (ppb) | AL=0.015 | 1000 | AL=15 | 0 | Corrosion of household plumbing systems; Erosion of natural deposits | Infants and children who drink water containing lead in excess of the AL could experience delays in their physical or mental development. Children could show slight deficits in attention span and learning abilities. Adults who drink this water over many years could develop kidney problems or high blood pressure. | | | | | | | (23) Mercury [inorganic] (ppb) | 0.002 | 1000 | 2 | 2 | Erosion of natural deposits; Discharge from refineries and factories; Runoff from landfills; Runoff from cropland | Some people who drink water containing inorganic mercury well in excess of the PMCL over many years could experience kidney damage. | | | | | | | (24) Nitrate (ppm) | 10 | | 10 | 10 | Runoff from fertilizer use; Leaching from septic tanks, sewage; Erosion of natural deposits | Infants younger than the age of six months who drink water containing nitrate in excess of the PMCL could become seriously ill and, if untreated, may die. Symptoms include shortness of breath and blue baby syndrome. | | | | | | | (25) Nitrite (ppm) | 1 | | 1 | 1 | Runoff from fertilizer use; Leaching from septic tanks, sewage; Erosion of natural deposits | Infants younger than the age of six months who drink water containing nitrite in excess of the PMCL could become seriously ill and, if untreated, may die. Symptoms include shortness of breath and blue baby syndrome. | | | | | | | (26) Total Nitrate and Nitrite | 10 | | n/a | 10 | n/a | Infants younger than the age of six months who drink water containing nitrate and nitrite in excess of the PMCL could become seriously ill and, if untreated, may die. Symptoms include shortness of breath and blue baby syndrome. | | | | | | | (27) Selenium (ppb) | 0.05 | 1000 | 50 | 50 | Discharge from petroleum and metal refineries; Erosion of natural deposits; Discharge from mines | Selenium is an essential nutrient. However, some people who drink water containing selenium in excess of the PMCL over many years could experience hair or fingernail losses, numbness in fingers or toes, or problems with their circulation. | | | | | | | (28) Thallium (ppb) | 0.002 | 1000 | 2 | 0.5 | Leaching from ore-processing sites; Discharge from electronics, glass, and drug factories | Some people who drink water containing thallium in excess of the PMCL over many years could experience hair loss, changes in their blood, or problems with their kidneys, intestines, or liver. | | | | | | | Synthetic Organic Chemicals including Pesticides and Herbicides | | | | | | | | | | | | | (29) 2,4-D (ppb) | 0.07 | 1000 | 70 | 70 | Runoff from herbicides used on row crops | Some people who drink water containing the weed killer 2,4-D well in excess of the PMCL over many years could experience problems with their kidneys, liver, or adrenal glands. | | | | | | | (30) 2,4,5-TP [Silvex] (ppb) | 0.05 | 1000 | 50 | 50 | Residue of banned herbicide | Some people who drink water containing silvex in excess of the PMCL over many years could experience liver problems. | | | | | | | (31) Acrylamide | TT | | TT | 0 | Added to water during sewage or wastewater treatment | Some people who drink water containing high levels of acrylamide over a long period of time could have problems with their nervous system or blood and may have an increased risk of getting cancer. | | | | | | | (32) Alachlor (ppb) | 0.002 | 1000 | 2 | 0 | Runoff from herbicide used on row crops | Some people who drink water containing alachlor in excess of the PMCL over many years could have problems with their eyes, liver, kidneys, or spleen, or experience anemia and may have an increased risk of getting cancer. | | | | | | | (33) Atrazine (ppb) | 0.003 | 1000 | 3 | 3 | Runoff from herbicide used on row crops | Some people who drink water containing atrazine well in excess of the PMCL over many years could experience problems with their cardiovascular system or reproductive difficulties. | | | | | | | (34) Benzo(a)pyrene [PAH] | 0.0002 | 1,000,000 | 200 | 0 | Leaching from linings of water storage tanks and distribution lines | Some people who drink water containing benzo(a)pyrene in excess of the PMCL over many years could experience reproductive difficulties and may have an increased risk of getting cancer. | | | | | | | (35) Carbofuran (ppb) | 0.04 | 1000 | 40 | 40 | Leaching of soil fumigant used on rice and alfalfa | Some people who drink water containing carbofuran in excess of the PMCL over many years could experience problems with their blood, or nervous or reproductive systems. | | | | | | | (36) Chlordane (ppb) | 0.002 | 1000 | 2 | 0 | Residue of banned termiticide | Some people who drink water containing chlordane in excess of the PMCL over many years could experience problems with their liver or nervous system, and may have an increased risk of getting cancer. | | | | | | | (37) Dalapon (ppb) | 0.2 | 1000 | 200 | 200 | Runoff from herbicide used on rights of way | Some people who drink water containing dalapon well in excess of the PMCL over many years could experience minor kidney changes. | | | | | | | (38) Di(2-ethylhexyl) adipate (ppb) | 0.4 | 1000 | 400 | 400 | Discharge from chemical factories | Some people who drink water containing di(2-ethyhexyl)adipate well in excess of the PMCL over many years could experience toxic effects, such as weight loss, liver enlargement or possible reproductive difficulties. | | | | | | | (39) Di(2-ethylhexyl)phthalate (ppb) | 0.006 | 1000 | 6 | 0 | Discharge from rubber and chemical factories | Some people who drink water containing di(2-ethylhexyl)phthalate in excess of the PMCL over many years may have problems with their liver, or experience reproductive difficulties, and may have an increased risk of getting cancer. | | | | | | | (40) Dibromochloropropane (DBCP) (ppt) | 0.0002 | 1,000,000 | 200 | 0 | Runoff or leaching from soil fumigant used on soybeans, cotton, pineapples, and orchards | Some people who drink water containing DBCP well in excess of the PMCL over many years could experience reproductive problems and may have an increased risk of getting cancer. | | | | | | | (41) Dinoseb (ppb) | 0.007 | 1000 | 7 | 7 | Runoff from herbicide used on soybeans and vegetables | Some people who drink water containing dinoseb well in excess of the PMCL over many years could experience reproductive difficulties. | | | | | | | (42) Diquat (ppb) | 0.02 | 1000 | 20 | 20 | Runoff from herbicide use | Some people who drink water containing diquat in excess of the PMCL over many years could get cataracts. | | | | | | | (43) Dioxin [2,3,7,8-TCDD] (ppq) | 0.00000003 | 1,000,000,000 | 30 | 0 | Emissions from waste incineration and other combustion; Discharge from chemical factories | Some people who drink water containing dioxin in excess of the PMCL over many years could experience reproductive difficulties and may have an increased risk of getting cancer. | | | | | | | (44) Endothall (ppb) | 0.1 | 1000 | 100 | 100 | Runoff from herbicide use | Some people who drink water containing endothall in excess of the PMCL over many years could experience problems with their stomach or intestines. | | | | | | | (45) Endrin (ppb) | 0.002 | 1000 | 2 | 2 | Runoff of banned insecticide | Some people who drink water containing endrin in excess of the PMCL over many years could experience liver problems. | | | | | | | (46) Epichlorohydrin | TT | | TT | 0 | Discharge from industrial chemical factories; An impurity of some water treatment chemicals | Some people who drink water containing high levels of epichlorohydrin over a long period of time could experience stomach problems and may have an increased risk of getting cancer. | | | | | | | (47) Ethylene dibromide (ppt) | 0.00005 | 1,000,000 | 50 | 0 | Discharge from petroleum refineries | Some people who drink water containing ethylene dibromide in excess of the PMCL over many years could experience problems with their liver, stomach, reproductive system, or kidneys, and may have an increased risk of getting cancer. | | | | | | | (48) Glyphosate (ppb) | 0.7 | 1000 | 700 | 700 | Runoff from herbicide use | Some people who drink water containing glyphosate in excess of the PMCL over many years could experience problems with their kidneys or reproductive difficulties. | | | | | | | (49) Heptachlor (ppt) | 0.0004 | 1,000,000 | 400 | 0 | Residue of banned pesticide | Some people who drink water containing heptachlor in excess of the PMCL over many years could experience liver damage and may have an increased risk of getting cancer. | | | | | | | (50) Heptachlor epoxide (ppt) | 0.0002 | 1,000,000 | 200 | 0 | Breakdown of heptachlor | Some people who drink water containing heptachlor epoxide in excess of the PMCL over many years could experience liver damage and may have an increased risk of getting cancer. | | | | | | | (51) Hexachlorobenzene (ppb) | 0.001 | 1000 | 1 | 0 | Discharge from metal refineries and agricultural chemical factories | Some people who drink water containing hexachlorobenzene in excess of the PMCL over many years could experience problems with their liver or kidneys or adverse reproductive effects and may have an increased risk of getting cancer. | | | | | | | (52) Hexachlorocyclopentadiene (ppb) | 0.05 | 1000 | 50 | 50 | Discharge from chemical factories | Some people who drink water containing hexachlorocyclopentadiene well in excess of the PMCL over many years could experience problems with their stomach or kidneys. | | | | | | | (53) Lindane (ppt) | 0.0002 | 1,000,000 | 200 | 200 | Runoff or leaching from insecticide used on cattle, lumber, gardens | Some people who drink water containing lindane in excess of the PMCL over many years could experience problems with their kidneys or liver. | | | | | | | (54) Methoxychlor (ppb) | 0.04 | 1000 | 40 | 40 | Runoff or leaching from insecticide used on fruits, vegetables, alfalfa, livestock | Some people who drink water containing methoxychlor in excess of the PMCL over many years could experience reproductive difficulties. | | | | | | | (55) Oxamyl [Vydate] (ppb) | 0.2 | 1000 | 200 | 200 | Runoff or leaching from insecticide used on apples, potatoes, and tomatoes | Some people who drink water containing oxamyl in excess of the PMCL over many years could experience slight nervous system effects. | | | | | | | (56) PCBs [Polychlorinated biphenyls] (ppt) | 0.0005 | 1,000,000 | 500 | 0 | Runoff from landfills; Discharge of waste chemicals | Some people who drink water containing PCBs in excess of the PMCL over many years could experience changes in their skin, problems with their thymus gland, immune deficiencies, or reproductive or nervous system difficulties and may have an increased risk of getting cancer. | | | | | | | (57) Pentachlorophenol (ppb) | 0.001 | 1000 | 1 | 0 | Discharge from wood preserving factories | Some people who drink water containing pentachlorophenol in excess of the PMCL over many years could experience problems with their liver or kidneys and may have an increased risk of getting cancer. | | | | | | | (58) Picloram (ppb) | 0.5 | 1000 | 500 | 500 | Herbicide runoff | Some people who drink water containing picloram in excess of the PMCL over many years could experience problems with their liver. | | | | | | | (59) Simazine (ppb) | 0.004 | 1000 | 4 | 4 | Herbicide runoff | Some people who drink water containing simazine in excess of the PMCL over many years could experience problems with their blood. | | | | | | | (60) Toxaphene (ppb) | 0.003 | 1000 | 3 | 0 | Runoff or leaching from insecticide used on cotton and cattle | Some people who drink water containing toxaphene in excess of the PMCL over many years could experience problems with their thyroid, kidneys, or liver and may have an increased risk of getting cancer. | | | | | | | Volatile Organic Chemicals | | | | | | | | | | | | | (61) Benzene (ppb) | 0.005 | 1000 | 5 | 0 | Discharge from factories; Leaching from gas storage tanks and landfills | Some people who drink water containing benzene in excess of the PMCL over many years could experience anemia or a decrease in blood platelets and may have an increased risk of getting cancer. | | | | | | | (62) Carbon tetrachloride (ppb) | 0.005 | 1000 | 5 | 0 | Discharge from chemical plants and other industrial activities | Some people who drink water containing carbon tetrachloride in excess of the PMCL over many years could experience problems with their liver and may have an increased risk of getting cancer. | | | | | | | (63) Chlorobenzene (ppb) | 0.1 | 1000 | 100 | 100 | Discharge from chemical and agricultural chemical factories | Some people who drink water containing chlorobenzene in excess of the PMCL over many years could experience problems with their liver or kidneys. | | | | | | | (64) o-Dichlorobenzene (ppb) | 0.6 | 1000 | 600 | 600 | Discharge from industrial chemical factories | Some people who drink water containing o-dichlorobenzene well in excess of the PMCL over many years could experience problems with their liver, kidneys, or spleen or changes in their blood. | | | | | | | (65) p-Dichlorobenzene (ppb) | 0.075 | 1000 | 75 | 75 | Discharge from industrial chemical factories | Some people who drink water containing p-dichlorobenzene in excess of the PMCL over many years could experience anemia, damage to their liver, kidneys, or circulatory systems. | | | | | | | (66) 1,2-Dichloroethane (ppb) | 0.005 | 1000 | 5 | 0 | Discharge from industrial chemical factories | Some people who drink water containing 1,2-dichloroethane in excess of the PMCL over many years may have an increased risk of getting cancer. | | | | | | | (67) 1,1-Dichloroethylene (ppb) | 0.007 | 1000 | 7 | 7 | Discharge from industrial chemical factories | Some people who drink water containing 1,1-dichloroethylene in excess of the PMCL over many years could experience problems with their liver. | | | | | | | (68) cis-1,2-Dichloroethylene (ppb) | 0.07 | 1000 | 70 | 70 | Discharge from industrial chemical factories | Some people who drink water containing cis-1,2-dichloroethylene in excess of the PMCL over many years could experience problems with their liver. | | | | | | | (69) trans-1,2-Dichloroethylene (ppb) | 0.1 | 1000 | 100 | 100 | Discharge from industrial chemical factories | Some people who drink water containing trans-1,2-dichloroethylene well in excess of the PMCL over many years could experience problems with their liver. | | | | | | | (70) Dichloromethane (ppb) | 0.005 | 1000 | 5 | 0 | Discharge from pharmaceutical and chemical factories | Some people who drink water containing dichloromethane in excess of the PMCL over many years could have liver problems and may have an increased risk of getting cancer. | | | | | | | (71) 1,2-Dichloropropane (ppb) | 0.005 | 1000 | 5 | 0 | Discharge from industrial chemical factories | Some people who drink water containing 1,2-dichloropropane in excess of the PMCL over many years may have an increased risk of getting cancer. | | | | | | | (72) Ethylbenzene (ppb) | 0.7 | 1000 | 700 | 700 | Discharge from petroleum refineries | Some people who drink water containing ethylbenzene well in excess of the PMCL over many years could experience problems with their liver or kidneys. | | | | | | | (73) Styrene (ppb) | 0.1 | 1000 | 100 | 100 | Discharge from rubber and plastic factories; Leaching from landfills | Some people who drink water containing styrene well in excess of the PMCL over many years could experience problems with their liver, kidneys, or circulatory system. | | | | | | | (74) Tetrachloroethylene (ppb) | 0.005 | 1000 | 5 | 0 | Discharge from factories and dry cleaners | Some people who drink water containing tetrachloroethylene in excess of the PMCL over many years could have problems with their liver and may have an increased risk of getting cancer. | | | | | | | (75) 1,2,4-Trichlorobenzene (ppb) | 0.07 | 1000 | 70 | 70 | Discharge from textile-finishing factories | Some people who drink water containing 1,2,4-trichlorobenzene well in excess of the PMCL over many years could experience changes in their adrenal glands. | | | | | | | (76) 1,1,1,-Trichloroethane (ppb) | 0.2 | 1000 | 200 | 200 | Discharge from metal degreasing sites and other factories | Some people who drink water containing 1,1,1-trichloroethane in excess of the PMCL over many years could experience problems with their liver, nervous system, or circulatory system. | | | | | | | (77) 1,1,2-Trichloroethane (ppb) | 0.005 | 1000 | 5 | 3 | Discharge from industrial chemical factories | Some people who drink water containing 1,1,2-trichloroethane well in excess of the PMCL over many years could have problems with their liver, kidneys, or immune systems. | | | | | | | (78) Trichloroethylene (ppb) | 0.005 | 1000 | 5 | 0 | Discharge from metal degreasing sites and other factories | Some people who drink water containing trichloroethylene in excess of the PMCL over many years could experience problems with their liver and may have an increased risk of getting cancer. | | | | | | | (79) Toluene (ppm) | 1 | | 1 | 1 | Discharge from petroleum factories | Some people who drink water containing toluene well in excess of the PMCL over many years could have problems with their nervous system, kidneys, or liver. | | | | | | | (80) Vinyl Chloride (ppb) | 0.002 | 1000 | 2 | 0 | Leaching from PVC piping; Discharge from plastic factories | Some people who drink water containing vinyl chloride in excess of the PMCL over many years may have an increased risk of getting cancer. | | | | | | | (81) Xylenes (ppm) | 10 | | 10 | 10 | Discharge from petroleum factories; Discharge from chemical factories | Some people who drink water containing xylenes in excess of the PMCL over many years could experience damage to their nervous system. | | | | | | | Disinfection Byproducts, Precursors, and Residuals | | | | | | | | | | | | | (82) TTHM [total trihalomethanes] (ppb) | 0.080 | 1000 | 80 | n/a | Byproduct of drinking water disinfection | Some people who drink water containing trihalomethanes (THMs) in excess of the PMCL over many years could experience problems with their liver, kidneys, or central nervous systems, and may have an increased risk of getting cancer. | | | | | | | (83) Haloacetic acids (HAA) (ppb) | 0.060 | 1000 | 60 | n/a | Byproduct of drinking water disinfection | Some people who drink water containing haloacetic acids in excess of the PMCL over many years may have an increased risk of getting cancer. | | | | | | | (84) Bromate (ppb) | 0.010 | 1000 | 10 | 0 | Byproduct of drinking water disinfection | Some people who drink water containing bromate in excess of the PMCL over many years may have an increased risk of getting cancer. | | | | | | | (85) Chloramines (ppm) | MRDL=4.0 | | MRDL=4.0 | MRDLG=4 | Water additive used to control microbes | Some people who use water containing chloramines well in excess of the MRDL could experience irritating effects to their eyes and nose. Some people who drink water containing chloramines well in excess of the MRDL could experience stomach discomfort or anemia. | | | | | | | (86) Chlorine (ppm) | MRDL=4.0 | | MRDL=4.0 | MRDLG=4 | Water additive used to control microbes | Some people who use water containing chlorine well in excess of the MRDL could experience irritating effects to their eyes and nose. Some people who drink water containing chlorine well in excess of the MRDL could experience stomach discomfort. | | | | | | | (87) Chlorine dioxide (ppb)^b | MRDL=0.8 | 1000 | MRDL=800 | MRDLG=800 | Water additive used to control microbes | Some infants and young children who drink water containing chlorine dioxide in excess of the MRDL could experience nervous system effects. Similar effects may occur in fetuses of pregnant women who drink water containing chlorine dioxide in excess of the MRDL. Some people may experience anemia. | | | | | | | (88) Chlorine dioxide, where any two consecutive daily samples collected at the entrance to the distribution system are above the MRDL.^a | MRDL=0.8 | | | MRDLG=0.8 | | The chlorine dioxide violations reported today are the result of exceedances at the treatment facility only, not within the distribution system that delivers water to consumers. Continued compliance with chlorine dioxide levels within the distribution system minimizes the potential risk of these violations to consumers. | | | | | | | (89) Chlorine dioxide, where one or more distribution system samples are above the MRDL.^a | MRDL=0.8 | | | MRDLG=0.8 | | The chlorine dioxide violations reported today include exceedances of EPA standard within the distribution system that delivers water to consumers. Violations of the chlorine dioxide standard within the distribution system may harm human health based on short-term exposures. Certain groups, including fetuses, infants, and young children, may be especially susceptible to nervous system effects from excessive chlorine dioxide exposure. | | | | | | | (90) Chlorite (ppm) | 1.0 | | 1.0 | 0.8 | Byproduct of drinking water disinfection | Some infants and young children who drink water containing chlorite in excess of the PMCL could experience nervous system effects. Similar effects may occur in fetuses of pregnant women who drink water containing chlorite in excess of the PMCL. Some people may experience anemia. | | | | | | | (91) Total organic carbon (ppm) | TT | | TT | n/a | Naturally present in the environment | Total organic carbon (TOC) has no health effects. However, total organic carbon provides a medium for the formation of disinfection byproducts. These byproducts include trihalomethanes (THMs) and haloacetic acids (HAAs). Drinking water containing these byproducts in excess of the PMCL may lead to adverse health effects, liver or kidney problems or nervous systems effects and may lead to an increased risk of getting cancer. | | | | | | | ^aThis information is for public notification purposes only. ^bThis information is for the CCR purposes only. ^cViolations of the treatment technique requirements for filtration and disinfection that involve turbidity exceedances may use the health effects language for turbidity instead. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

History

• Statutory Authority: §§ 32.1-12 and 32.1-70 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-550 Recordkeeping

A. The owner shall maintain all of the waterworks records in accordance with the Records Retention and Disposition Schedule of the Library of Virginia, General Schedule No. 7 for public utility records of county and municipal governments.

B. The owner shall retain at the waterworks or at a convenient location near the waterworks the following records for not less than the time periods specified:

1. Microbiological analyses and turbidity analyses, including records of any repeat samples collected and meeting the criteria for an extension of the 24-hour period for collecting repeat samples as required under 12VAC5-590-380 -- Five years.

2. Chemical Analyses -- 10 years.

3. The following information shall be provided for subdivisions B 1 and B 2 of this section:

a. Date, place, and time of sampling as well as the name of the person who collected the sample;

b. Identification of sample (e.g., routine, repeat, confirmation sample, source water, other);

c. Date of analysis;

d. Laboratory or person responsible for performing analysis;

e. Analytical method or technique used; and

f. Results of the analysis.

4. Individual filter monitoring required under 12VAC5-590-531 A 2 b -- Three years.

5. Results of disinfection profile including raw data and analysis -- Indefinitely.

6. Disinfection benchmarking including raw data and analysis -- Indefinitely.

7. Original records of all sampling data and analyses, reports, surveys, letters, evaluations, schedules, department determinations, and any other information required by 12VAC5-590-405 A 1 and 12VAC5-590-405 A 2, 12VAC5-590-405 B, 12VAC5-590-405 C, and 12VAC5-590-405 D pertaining to lead and copper -- 12 years.

8. Results from the initial round of source water monitoring under 12VAC5-590-401 B 1 and the second round of source water monitoring under 12VAC5-590-401 B 2 until three years after bin classification under 12VAC5-590-401 D 1 for the particular round of monitoring.

9. Any notification to the department that source water monitoring will not be conducted due to meeting the criteria of 12VAC5-590-401 B 4 -- Three years.

10. Results of treatment monitoring associated with microbial toolbox options under 12VAC5-590-401 E 3 through 12VAC5-590-401 E 7 and with uncovered finished water reservoirs under 12VAC5-590-415, as applicable, -- Three years.

11. Action taken to correct violations of this chapter-- Three years after last action with respect to violation involved.

12. The owner shall retain completed assessment forms for all Level 1 and Level 2 assessments conducted in accordance with 12VAC5-590-392 C, regardless of who conducts the assessment, and documentation of corrective actions completed as a result of those assessments, or other available summary documentation of the sanitary defects and correction actions taken under 12VAC5-590-392 D for a period not less than five years after completion of the assessment or corrective action, whichever is later.

13. Copies of reports, summaries, or communications relating to any sanitary surveys performed -- 10 years following inspection.

14. Variance or exemptions granted (and records related thereto) -- Five years following expiration of the variance or exemption.

15. Cross-connection control program records -- 10 years.

16. The owner of a waterworks that recycles flow, as stipulated in 12VAC5-590-395 C, shall collect and retain on file the recycle flow information for review and evaluation by the department. This information shall be retained for a minimum of 10 years. Information shall include, as a minimum:

a. Copy of the recycle notification submitted to the department.

b. List of all recycle flows and the frequency with which they are returned.

c. Average and maximum backwash flow rate through the filters and the average and maximum duration of the filter backwash process, in minutes.

d. Typical filter run length and a written summary of how the filter run length is determined.

e. The type of treatment provided for the recycle flow.

f. Data on the physical dimensions of the equalization or treatment units, typical and maximum hydraulic loading rates, type of treatment chemicals used, average dose, frequency of use, and frequency at which solids are removed, if applicable.

17. Copies of monitoring plans developed pursuant to this chapter shall be kept for the same period of time as the records of analyses taken under the plan are required to be kept under subsection A or B of this section, except as specified elsewhere in this chapter.

18. The owner shall retain the following additional records:

a. Plant operational records -- five years after the end of the calendar year;

b. Current organizational or staffing chart;

c. Record (As-built) engineering plans and specifications of facilities -- Retain for the life of the facility;

d. Equipment manuals for items in use -- Retain for the life of the equipment or facility;

e. Shop drawings of major equipment in use -- Retain for the life of the equipment;

f. Current list or chart of required laboratory tests with test frequencies and sampling locations;

g. Current preventive maintenance schedule;

h. Records of repair or replacement of equipment in use -- Retain for the life of the equipment;

i. Updated map of water distribution system; and

j. All accident reports -- Three years.

C. The owner of a waterworks with groundwater sources shall maintain the following records:

1. Corrective actions – --10 years.

2. Public notification as required by 12VAC5-590-540 -- Three years.

3. Invalidation of groundwater source samples -- Five years.

4. For consecutive waterworks, notification to the wholesale waterworks of coliform-positive samples -- Five years.

5. For a waterworks required to conduct compliance monitoring:

a. Department-specified minimum residual disinfectant --10 years.

b. Lowest daily residual disinfectant concentration -- Five years.

c. Dates and duration of any failure to maintain the department-specified minimum residual disinfectant concentration for a period of more than four hours -- Five years.

d. Department-specified compliance parameters for alternative treatment and records of the date and duration of any failure to meet the alternative treatment operating requirements for more than four hours -- Five years.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-005.11 § 2.22, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 12, Issue 2, eff. November 15, 1995; Volume 18, Issue 19, eff. July 3, 2002; Volume 19, Issue 20, eff. July 16, 2003; Volume 21, Issue 13, eff. April 6, 2005; Volume 25, Issue 5, eff. December 10, 2008; Volume 28, Issue 5, eff. December 7, 2011; Volume 33, Issue 3, eff. November 2, 2016; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-560 Safety

The owner of a waterworks shall institute a safety program to inform personnel of the known hazards, preventive measures, and emergency procedures pertaining to the operation of the waterworks in accordance with VOSH laws and regulations.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-005.12 § 2.23, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-565 Source water protection

A. A waterworks owned by a county, city, or town may exercise the authority pursuant to § 15.2-2109 of the Code of Virginia to protect the waterworks from pollution or injury.

B. The owner of a waterworks with a drinking water reservoir may establish a buffer around the intake to limit such uses as body contact recreation and boats powered by engines, pursuant to a plan acceptable to the department.

C. The owner of a waterworks should develop a source water protection plan for all the sources and report ongoing or completed protection initiatives to the department.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-570 Operational reporting requirements

A. Monthly operational reports.

1. A classified waterworks is required to report monthly information to the department no later than the 10th of the month following the month during which the monitoring period occurred.

2. A classified waterworks using conventional filtration shall report using the monthly operating report (MOR) form approved by the department. All other classified waterworks shall report the required information specified in Tables 570.1 through 570.14, based on the treatment processes employed. Monitoring data shall be collected for each day the operating staff attend to the operation of the facilities.

3. To determine if a waterworks using UV reactor systems is operating within validated conditions designed in accordance with 12VAC5-590-1005, the following parameters shall be monitored and reported: (i) on/off status for each reactor; (ii) flow rate through reactor train; (iii) UV intensity as measured by a UV sensor; (iv) lamp status; (v) lamp age; and (vi) UV transmittance. The operational set points shall be reported if set point control is used. The calculated UV dose shall be reported if other than a set point control is used.

4. An unclassified waterworks is required to report quarterly the following information specified in Table 570.1, where applicable, to the department no later than the 10th of the month following the calendar quarter during which the monitoring period occurred.

5. An unclassified waterworks that is using any of the treatment processes described in Tables 570.2 through 570.14 is required to report no later than the 10th of the month following the calendar month during which the monitoring occurred. The report shall contain the required information specified in Tables 570.1 through 570.14 based on the treatment processes employed. The monitoring data shall be collected at a minimum frequency as established by the department.

6. An owner of a waterworks that is required to submit an MOR to the office shall include any noncritical equipment failure or malfunction that could adversely affect water quality, public health, or service continuity that occurred during the applicable reporting month and was not resolved by the reporting deadline. For the purposes of this subsection, any noncritical equipment failure or malfunction that is effectively addressed by equipment repair or replacement, alternative equipment use, alternative system operation, or such other response shall be considered resolved.

7. The department may vary the reporting requirements on a case-by-case basis.

| Table 570.1 Baseline Data -- All Waterworks | | --- | | Public water system ID no. | | System name | | Reporting month and year (reporting quarter and year^a) | | Location (county) | | Number of connections, monthly average (maximum for reporting period^a) | | Population served, monthly average (quarterly average and maximum day^a) | | Total source water withdrawn, gpd | | Total source water treated, gpd | | Total finished water produced, gal/month (for each entry point) or Total water purchased, gal/month (at each consecutive connection) | | Operator name (printed and signature) | | Operator classification (Class 1 to Class 6) | | Operator DPOR certification no. | | Name and contact information of the emergency contact person (text, voice phone number) | | Required for an unclassified waterworks^a |

| Table 570.2 Chlorine Disinfection | | --- | | Chlorine compound used (chlorine gas, calcium hypochlorite or sodium hypochlorite) | | Amount of chlorine compound used at each application point, lb/day | | Residual disinfectant concentration (measured as total chlorine, free chlorine, combined chlorine, or chlorine dioxide) at entry point, mg/L | | Chlorite concentration (if chlorine dioxide is used), daily measurement at entry point, mg/L |

| Table 570.3 Chlorine Residual in the Distribution System | | --- | | Chlorine compound used (chlorine gas, calcium hypochlorite or sodium hypochlorite) | | Residual disinfectant concentration, measured as total chlorine, free chlorine, combined chlorine, or chlorine dioxide, mg/L (collected with each total coliform bacteria sample, in accordance with approved sampling plan) |

| Table 570.4 Rechlorination in the Distribution System | | --- | | Chlorine compound used (chlorine gas, calcium hypochlorite or sodium hypochlorite) | | Amount of chlorine compound used at each application point, lb/day | | Free chlorine residual concentration before rechlorination, mg/L | | Free chlorine residual concentration after rechlorination, mg/L | | Free chlorine residual, mg/L (measured and reported with each total coliform bacteria sample, in accordance with approved sampling plan) |

| Table 570.5 Iron and Manganese Treatment by Oxidation, Detention and Filtration | | --- | | Source water iron and manganese concentrations, mg/L (each source) | | Oxidant amount used, lb/day | | Finished water iron and manganese concentrations, mg/L (each filter) | | Finished water pH (each filter) | | Filter hours between backwash (each filter) |

| Table 570.6 Iron and Manganese Treatment by Ion Exchange | | --- | | Ion exchange material (type, manufacturer, and product name) | | Source water iron and manganese concentrations, mg/L (each source) | | Finished water iron and manganese concentrations, mg/L (each unit softener) | | Finished water pH (each unit softener) | | Head loss, psi (each unit softener) | | Regeneration date and method (each unit softener) | | Backwash date and duration of washing (each unit softener) | | Backwash rate, gpm (each unit softener) |

| Table 570.7 Sequestration of Iron and Manganese | | --- | | Chemical used (manufacturer and product name) | | Quantity used, lb/day (average) | | Source water iron and manganese concentrations, mg/L (each source) | | Finished water (entry point) iron and manganese concentrations, mg/L | | Finished water (entry point) treatment chemical concentration, mg/L | | Treatment chemical residual concentration, mg/L (value at distal end of distribution system, report at same frequency as free chlorine residual testing) |

| Table 570.8 pH Adjustment or Corrosion Control by Chemical Addition | | --- | | Chemical used (manufacturer and product name) | | Quantity used, lb/day (average) | | Source water pH | | Finished water (entry point) pH | | Finished water (entry point) treatment chemical concentration, mg/L (if required water quality parameter for compliance with lead and copper) |

| Table 570.9 Cation Exchange Softening | | --- | | Cation exchange material (type, manufacturer, and product name) | | Regeneration date and method (each unit) | | Backwashing date and duration of washing (each unit) | | Softener influent hardness, mg/L as CaCO₃ (each source) | | Softener effluent hardness, mg/L as CaCO₃ (each unit) | | Stabilization chemical type, weight, daily dosage | | Finished water (entry point) pH | | Finished water (entry point) alkalinity, mg/L | | Finished water (entry point) hardness, as CaCO₃ |

| Table 570.10 Fluoridation | | --- | | Chemical used (manufacturer and product name) | | Fluoride used, lb/day | | Fluoride dosage, mg/L (daily) | | Water treated, MGD | | Finished water (entry point) fluoride concentration, mg/L (maximum, minimum, and average) |

| Table 570.11 Microfiltration or Ultrafiltration | | --- | | Hours unit in operation | | Source water flow, gpd | | Filtrate volume, gpd | | Recirculated during suspension mode (volume or percent of feed flow, per day) | | Waste volume, gpd | | Maximum stabilized flux, gpd/ft² | | Source water turbidity, NTU bench test (daily) | | Source water turbidity, NTU in line (collected at same time as bench test) | | Source water turbidity, NTU in-line (maximum daily) | | Source water alkalinity, mg/L as CaCO₃ (daily) | | Source water hardness, mg/L as CaCO₃ (daily) | | Source water temperature, ^oC (daily) | | Source water pH (daily) | | Filtered water turbidity, NTU bench test (daily) | | Filtered water turbidity, NTU in line (collected at same time as bench test) | | Filtered water turbidity, NTU in line (maximum daily) | | Pressure loss across pre-filter, psi (daily) (if pre-filters are automatically cleaned, reporting is not required) | | Number of membrane modules in use (daily) | | Direct integrity test start time (daily) | | Direct integrity test starting pressure, psi (each membrane unit, daily) | | Direct integrity test final pressure, psi (daily) | | Direct integrity test duration, minutes (daily) | | Direct integrity test pressure decay rate, psi/minute (daily) | | Direct integrity test Log Removal Value (daily) | | Trans-membrane pressure, psi (daily) | | Trans-membrane pressure before clean-in-place, psi | | Trans-membrane pressure after clean-in-place, psi | | Cleaning solution used (manufacturer and product name) | | pH of rinse water after clean-in-place | | Calibrations completed (itemized instruments with dates completed) | | Module repairs or replacements (itemized with dates repairs or replacements) | | Entry point log inactivation of Giardia by disinfection (daily) |

| Table 570.12 Reverse Osmosis | | --- | | Hours unit in operation | | Pre-filter inlet pressure, psi (daily) | | Pre-filter outlet pressure, psi (daily) | | RO Inlet pressure, psi (daily) | | RO outlet pressure, psi (daily) | | Total permeate flow, gpd | | Concentrate flow (bypass), gpd | | Finished water flow, gpd | | Total finished water (entry point) flow, gpd | | Pre RO TDS, mg/L (daily) | | Post RO TDS, mg/L (daily) | | Pre RO turbidity, NTU (daily) | | Post RO turbidity, NTU | | Pre RO conductivity, uS/cm (daily) | | Post RO conductivity, uS/cm (daily) | | Finished water conductivity, uS/cm (daily) | | Source water pH (daily) | | Permeate pH (daily) | | Finished water (entry point) pH (daily) | | Module repairs or replacements (itemized with dates of repairs or replacements) |

| Table 570.13 UV Disinfection | | --- | | All waterworks using ultraviolet (UV) disinfection must report the following: | | Total run time, hours (per unit) Lamp status for each reactor train Lamp age for each reactor train Total production, MGD or gpd Flow Rates, minimum, maximum and average, MGD or gpd for each reactor train | | To receive disinfection credit, the following shall also be reported: | | Number of off-specification events Total off-specification volume, gal Percent off-specification volume UV Intensity setpoint, W/m² (if using intensity setpoint approach, daily) UV Intensity for each reactor, minimum, W/m² (if using intensity setpoint approach, daily) UV Intensity sensor calibration date for each reactor Required dose, mJ/cm² (if using calculated dose approach) UV Transmittance (UVT) for each reactor, daily percentage (if using calculated dose approach) Calculated dose for each reactor, daily minimum, mJ/cm² (if using calculated dose approach) Validated dose for each reactor, daily minimum, mJ/cm² (if using calculated dose approach) UVT analyzer calibration date (if using calculated dose approach) UV intensity sensor correction factor |

| Table 570.14 Ozone Disinfection | | --- | | All waterworks using ozone disinfection must report the following: Ozone applied, lb/day and mg/L. Bromate concentration (mg/L), at the entry point to the distribution system, monthly. | | To receive disinfection credit, the waterworks shall also report: Minimum ozone concentration C_initial from first sample point (Effluent Method) or C_geo (Log Integration Method) in all contactors during peak flow, daily. Minimum and average ozone concentration C_final (mg/L) for each contactor in service, daily. Log Inactivation by ozonation, for Giardia, virus and, if applicable, Cryptosporidium, daily at peak flow and the minimum CT, daily. |

B. The owner shall report the following incidents:

1. Any critical equipment failure or malfunction or contaminant release shall be reported to the office as soon as practicable but no more than two hours after discovery.

2. Water pressure below the 20 psi minimum required in the distribution system, including zero or negative pressure, that is not caused by a critical equipment failure or malfunction shall be reported to the department within 24 hours.

3. Any other situation that occurs with the waterworks that presents or may present an imminent and substantial threat to public health shall be reported to the department within 24 hours.

History

• Statutory Authority: §§ 32.1-12, 32.1-170, and 32.1-174.5 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-005.13 § 2.24, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021; Errata, 37:22 VA.R. 3448 June 21, 2021; amended, Virginia Register Volume 42, Issue 5, eff. November 19, 2025.

Article 4 Cross Connection Control and Backflow Prevention in Waterworks [Repealed]

12VAC5-590-580 General requirements for cross-connection control and backflow prevention

A. Every owner shall establish and enforce a cross-connection control program (CCCP) in accordance with 12VAC5-590-360. The goal of the CCCP is to prevent the intrusion of contamination into the distribution system via cross-connections and backflow. The owner shall document the CCCP activities in a cross-connection control plan and submit the written document to the department for review and approval.

B. No owner shall install, maintain, or allow a service connection to any premises where cross-connections to a waterworks or a consumer's water system exist, unless the owner and department ensure the cross-connections are adequately safeguarded.

C. No owner shall install, maintain, or allow any connection whereby water from an auxiliary water system may enter a waterworks or consumer's water system, unless the owner and department approve the auxiliary water system, the method of connection, and use of such system ].

D. The owner, in accordance with 12VAC5-590-510 C, shall maintain acceptable working pressures in the distribution system to reduce the potential for backflow to occur.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-006.01 § 2.25, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-590 (Repealed.)

History

• Historical Notes: Derived from VR355-18-006.02 § 2.26, eff. June 23, 1993; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-600 Cross-connection control program responsibilities

A. The owner shall establish and implement a CCCP consistent with the extent of the distribution system and the consumers served by the waterworks. The owner shall review the CCCP and written cross-connection control plan not less than every five years and update it as necessary to satisfy the requirements of this chapter. The owner shall submit updates to the department to obtain approval. The department may review the plan upon request. This program shall include at least one designated individual assigned by the owner. Requirements for this position shall include training and experience in cross-connection control programs.

B. The CCCP shall not be in conflict with the USBC and applicable building code regulations, including 13VAC5-63 or subsequent regulations promulgated by the Board of Housing and Community Development.

C. The CCCP shall ensure complete assessments of every consumer's water system and shall determine both the degree of hazard and the appropriateness of existing safeguards to prevent contamination from cross-connections and backflow.

D. The CCCP shall ensure testing, maintenance, and repairs of all backflow prevention assemblies, backflow elimination methods, and backflow prevention devices required and installed pursuant to 12VAC5-590-610.

E. 13VAC5-63-530, which incorporates the International Property Maintenance Code into the USBC, requires testing of RPZ assemblies, double check valve assemblies, double check detector backflow assemblies, and pressure vacuum breaker assemblies after initial installation, immediately after repairs or relocation, and annually thereafter. The CCCP shall establish procedures for completing and monitoring operational tests, or other evaluation procedures as appropriate, at least annually, and after installation, relocation, or repairs, for testable backflow prevention assemblies, devices, and methods that provide containment. The CCCP may include a public education program to:

1. Prompt consumer self-assessments, increase the awareness of cross-connections, and inform the consumer of the public health hazards of backflow.

2. The public education program, if provided as part of the CCCP, shall include, at a minimum, the following:

a. Causes of backflow;

b. Hazards and health effects of cross-connections and backflow;

c. Resources available to identify actual or potential cross-connections;

d. Safeguards to use to eliminate or control the hazards at the point of use; and

e. Sources for additional information.

F. The CCCP shall provide a method to discontinue or refuse water service to the consumer to ensure that the waterworks is adequately protected from cross-connections and backflow if any of the following conditions occur:

1. The consumer does not install, test and maintain a required backflow prevention assembly or backflow elimination method in accordance with the applicable sections of this chapter;

2. The consumer allows a required backflow prevention assembly or backflow elimination method to become inoperable or the consumer removes or bypasses it; or

3. The owner knows an unprotected or inadequately protected cross-connection exists on the premises and determines that there is inadequate backflow prevention at the service connection.

G. In the event of backflow of contaminants into the waterworks, the owner shall promptly take or cause corrective action to confine and eliminate the contamination. The owner shall report the event to the department within one business day in the most expeditious manner. The owner shall submit a written report by the 10th day of the month following the month during which backflow occurred addressing the incident, its causes and effects, and safeguards required or other action taken.

H. The owner shall maintain an inventory and records of testing, repairs, and maintenance of all backflow prevention assemblies, backflow elimination methods, and backflow prevention devices required and installed under 12VAC5-590-610 C. In the case of single-family residences subject to 12VAC5-590-610 C 5, the owner may determine whether or not to maintain an inventory or records. The department recommends the owner follow best practices identified in the AWWA Manual of Water Supply Practices M14 and the EPA Cross-Connection Control Manual.

I. The owner shall maintain an inventory and records of testing, repairs, and maintenance of all backflow prevention assemblies, backflow elimination methods, and backflow prevention devices required and installed under 12VAC5-590-610 E.

J. The owner shall maintain records related to the CCCP implementation, and any other records the department requires in accordance with 12VAC5-590-550.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-006.03 § 2.27, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-610 Containment of backflow

A. The owner shall ensure installation of backflow prevention assemblies or backflow elimination methods (i) at the service connection or (ii) downstream of the service connection but before any unprotected takeoffs.

B. Where the consumer's water system is not intricate or complex and where actual or potential cross-connection hazards can be eliminated or controlled, instead of containment, the owner may allow consumers to use point-of-use isolation protection by application of appropriate backflow prevention assemblies, backflow prevention devices, or backflow elimination methods complying with the USBC.

C. A backflow prevention assembly or backflow elimination method shall be installed where the following conditions exist:

1. A substance is handled in such a manner as to create an actual or potential hazard to a waterworks (this shall include premises having sources or systems containing process fluids or waters originating from a waterworks which are no longer under the control of the owner);

2. There exists internal cross-connections that, in the judgment of the owner or the department, may not be easily correctable or have intricate or complex plumbing arrangements that make it impracticable to determine whether or not cross-connections exist;

3. There are security requirements or other prohibitions or restrictions that prevent the assessment of all potential cross-connections that may impair the quality of the water delivered;

4. There is a repeated history of cross-connections being established or reestablished;

5. There are fire protection systems, lawn sprinkler systems, or irrigation systems;

6. The owner or department can show that a potential cross-connection hazard exists.

D. The owner shall ensure that consumers equip premises having booster pumps or fire pumps connected to the waterworks with control devices to prevent a reduction of pump suction line pressure to less than 20 psig.

E. A backflow prevention assembly or backflow elimination method shall be installed at consumer water systems serving the following types of facilities, including:

1. Hospitals, mortuaries, clinics, veterinary establishments, nursing homes, and medical buildings;

2. Laboratories;

3. Piers, docks, and waterfront facilities;

4. Sewage treatment plants, sewage pumping stations, or storm water pumping stations;

5. Food and beverage processing plants;

6. Chemical plants, dyeing plants, and pharmaceutical plants;

7. Metal plating industries;

8. Petroleum or natural-gas processing or storage plants;

9. Radioactive materials processing plants or nuclear reactors;

10. Car washes and laundries;

11. Buildings with commercial, industrial, or institutional occupants served through a master meter;

12. Water loading facilities;

13. Slaughter houses and poultry processing plants;

14. Farms where the water is used for other than household purposes;

15. Commercial greenhouses and nurseries;

16. Health clubs with swimming pools, therapeutic baths, hot tubs, or saunas;

17. Paper and paper-product plants and printing plants;

18. Pesticide or exterminating companies and their vehicles with storage or mixing tanks;

19. Facilities that blend, store, package, transport, or treat chemicals, and their related vehicles;

20. Schools or colleges with laboratory facilities;

21. Highrise buildings (four or more stories);

22. Multiuse commercial, office or warehouse facilities; and

23. Others specified by the owner or the department when reasonable cause can be shown for a potential backflow or cross-connection hazard.

F. All temporary or emergency service connections shall be protected where reasonable cause can be shown for a potential backflow or cross-connection hazard. Backflow prevention assemblies or backflow elimination methods used shall be appropriately certified or approved to match the requirements of this section.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-006.04 § 2.28, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-620 (Repealed.)

History

• Historical Notes: Derived from VR355-18-006.05 § 2.29, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-630 Backflow prevention assemblies, devices, and backflow elimination methods for containment

A. Any backflow prevention assembly or backflow elimination method or backflow prevention device shall be of the approved type and shall comply with the USBC.

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B. General safeguards

1. The backflow prevention assembly or backflow elimination method or backflow elimination device used shall depend on the degree of hazard that exists or may exist. The safeguard shall ensure maintenance of the distribution system water quality and its usefulness.

2. The degree of hazard, either high or low, is based on (i) the nature of the contaminant; (ii) the potential of the health hazard; (iii) the potential method of backflow (either by backpressure or by backsiphonage); and (iv) the potential effect on waterworks structures, equipment, and appurtenances used in the storage, collection, purification, treatment, and distribution of potable water. Table 630.1 shall be used as a guide to determine the degree of hazard for any situation.

| Table 630.1 Determination of Degree of Hazard | | | --- | --- | | Cross-connections that meet or may meet the following conditions shall be rated at the corresponding degree of hazard. | | | High Hazard | Low Hazard | | The contaminant would be toxic, poisonous, noxious, unhealthy, or of unknown quality. | The contaminant would only degrade the quality of the water aesthetically or impair the usefulness of the water. | | A health hazard would exist. | A health hazard would not exist. | | The contaminant would disrupt the service of piped water for human consumption. | The contaminant would not disrupt service of piped water for human consumption. | | Backflow would be by either backpressure or backsiphonage. | Backflow would occur by backsiphonage. | | Examples: lawn irrigation systems, fire sprinkler systems with chemical additives or antifreeze, sewage, used water, nonpotable water, auxiliary water systems, and mixtures of water and other liquids, gases, or other chemicals. | Examples: food residuals, coffee machines, non-carbonated beverage dispensers, and residential fire sprinkler systems constructed of materials designed for potable water flow. |

3. The USBC and the manufacturer's specifications shall be used to determine the appropriateness of the backflow prevention assembly or backflow prevention device application for containment.

C. Owners shall not allow the installation of backflow prevention devices or backflow prevention assemblies with openings, outlets, or vents that are designed to operate or open during backflow prevention:

1. In areas subject to flooding or in pits;

2. In areas with atmospheric conditions that represent a contamination threat to the potable water supply; and

3. In such a manner as to be able to be bypassed.

D. Starting January 1, 2023, persons testing and repairing backflow prevention assemblies and backflow prevention devices shall be certified by a Commonwealth of Virginia tradesman certification program (identified by DPOR as backflow prevention device workers). Until January 1, 2023, persons testing and repairing backflow prevention assemblies and backflow prevention devices shall be qualified to perform such work as demonstrated by possessing a certification or license from a local or state agency having legal authority or shall possess a certificate of completion of applicable vocational training acceptable to the owner.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-006.06 § 2.30, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 31, Issue 1, eff. October 10, 2014; Volume 37, Issue 20, eff. June 23, 2021.

Article 1 General [Repealed]

12VAC5-590-640 General design considerations

A. Waterworks shall conform to the Public Water Supply Law, Article 2 of Chapter 6 of Title 32.1 of the Code of Virginia. Community waterworks shall be designed to provide for the estimated water demand for 10 to 30 years hence under predicted growth conditions. All waterworks shall be designed so that they can readily be increased in capacity except where circumstances preclude the probability of expansion. Expansion by modular steps should be considered.

B. Waterworks design shall be based on sound engineering practice substantiated in the engineer's design and approved by the department. Historical data or typical usage figures of waterworks with similar service area characteristics and appropriate peaking factors shall be used to support the design. USBC and design standards may be referenced for noncommunity waterworks, as appropriate.

1. Community waterworks shall be designed to meet or exceed the estimated maximum daily water demand of the service area at the design year. The design shall account for diurnal demand patterns and special demands placed on the waterworks such as firefighting, industrial use, and wholesale customers.

2. Noncommunity waterworks shall be designed to meet or exceed the peak hour demand of the proposed services. Either pump capacity or storage capacity or both may be utilized to meet the peak hour demand.

3. Effective storage.

a. Community waterworks shall provide sufficient finished water effective storage to enable the waterworks to meet the estimated maximum daily water demand at the design year. Compliance with this requirement is normally determined by the use of a hydraulic model. In the absence of a hydraulic model, effective storage shall be a minimum of one-half of estimated maximum daily water demand of the waterworks at the design year.

b. There is no minimum finished water effective storage requirement for noncommunity waterworks.

c. Effective storage of atmospheric storage tanks shall be the volume available to store finished water in atmospheric reservoirs or tanks, measured as the difference between the overflow elevation, or the normal maximum operating level, and the minimum storage elevation. For atmospheric tanks that use a portion of their volume to generate distribution system pressure, the minimum storage elevation is that elevation of water in the tank that can provide a minimum pressure of 20 psig throughout that tank's service area under distribution system-wide maximum daily water demand.

d. Effective storage of pressure storage tanks shall be one-third of the nominal pressure vessel storage capacity.

C. Waterworks shall be designed to provide a minimum residual pressure of 20 psig at all service connections. Design shall be based on the most restrictive conditions, defaulting to the greater of peak hour demand or maximum daily water demand plus applicable fire flows. Fire flow design values shall be identified by the engineer after coordination among the owner, local and state building officials, and fire officials. Distribution system hydraulic modeling may be used to demonstrate compliance with this requirement.

D. Materials used in the construction of waterworks that are in contact with the product water shall comply with NSF/ANSI/CAN Standard 61-2020 or an approved equivalent.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-007.01 § 3.1, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-650 (Repealed.)

History

• Historical Notes: Derived from VR355-18-007.02 § 3.2, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-660 Site location

A. Wells and water treatment plants shall be located above the projected 100-year flood elevation. A lower elevation may be considered if it can be adequately shown that the wells or treatment plants can be protected from flooding. Site grading and adequate drainage shall be provided. Springs subject to flooding shall not be approved. See 12VAC5-590-840 E for additional well location requirements.

B. The waterworks pumping and treatment facilities shall be readily accessible in all seasons. Access roads shall be provided.

C. Functional aspects of the site shall be considered in design, including the convenience of transportation facilities to the site and the availability of electric power from more than one source.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-007.03 § 3.3, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-670 Site size

A. The area reserved around a well or spring site shall conform to 12VAC5-590-840 D and 12VAC5-590-840 E.

B. The treatment plant site shall be of ample size to accommodate expansion, and ample space shall be provided at the treatment site for adequate handling of treatment plant residuals.

C. The disposal of water treatment plant residuals shall conform to the State Water Control Law, Chapter 3.1 of Title 62.1 of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-007.04 § 3.4, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-680 Treatment process selection and BAT

A. The following shall be considered when selecting treatment processes: (i) the quality and variability of the source water and (ii) possible future changes in the quality and quantity of the source water.

B. The design shall employ best available technologies (BAT) for achieving compliance with the PMCLs for organic chemicals listed in 40 CFR 141.61 and BAT for achieving compliance with the PMCLs for inorganic chemicals listed in 40 CFR 141.62.

C. The design shall employ BAT for achieving compliance with the PMCLs for radionuclides listed in 40 CFR 141.66, including radium-226, radium-228, uranium, gross alpha particle activity, beta particle, and photon radioactivity. The design shall consider the system size and use limitations for specific technologies listed in 40 CFR 141.66.

D. Alternative technologies may be employed when approved by the department.

E. When treatment technique requirements have been established instead of PMCLs or ALs, the design shall employ processes specified by these requirements.

F. POU devices shall not be used to achieve compliance with the treatment technique for microbial contaminants. POE or POU devices may be considered for short-term interim use when approved as a condition of a variance or exemption issued by the commissioner.

G. For softening, TDS removal, organics removal, and other treatment purposes, the use of RO and NF shall be in accordance with ANSI/AWWA Standard B114-16, or as allowed by the department on a case-by-case basis.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-007.05 § 3.5, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-690 (Repealed.)

History

• Historical Notes: Derived from VR355-18-007.06 § 3.6, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-700 Metering total water production

A. The design of all community waterworks shall provide metering of total water production.

B. The design of all NTNCs that provide treatment or have a design capacity of greater than 300,000 gallons per month shall provide metering of total water production.

C. The design of all TNCs that provide treatment or have a design capacity of greater than 300,000 gallons per month shall provide metering of total water production.

D. If the waterworks treatment process results in a waste flow, including filter backwash, ion exchange regenerate, or residual solids, then the design shall provide metering of total source water withdrawn and finished water produced.

E. Metering of total water production at waterworks that do not meet the conditions found in subsections A through D of this section should be provided.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-007.07 § 3.7, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-710 (Repealed.)

History

• Historical Notes: Derived from VR355-18-007.08 § 3.8, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-720 Building design and construction

A. In accordance with the USBC, Chapter 6 (§ 36.97 et seq.) of Title 36 of the Code of Virginia, and the Statewide Fire Prevention Code (§ 27.94 et seq.) of Title 27 of the Code of Virginia, all waterworks building design and construction shall include necessary features that will assure a functional and safe environment, including adequate ventilation, lighting, heating, drainage, dehumidification, and accessibility to equipment for operation and maintenance.

B. Consistent with subdivision A of this section, the waterworks building design and layout shall incorporate safety provisions to protect waterworks operators and other personnel, in accordance with Article 1 (§ 40.1-22) of Chapter 3 of Title 40.1 of the Code of Virginia. These provisions must comply with federal occupational safety and health standards and regulations promulgated under 29 USC § 651 et seq. and shall include separation of incompatible chemicals, confined space entry, handrails and guards, ladders, lighting, warning signs, smoke detectors, chlorine leak detectors, protective equipment, safety showers, eye washes, and fire extinguishers.

C. Positive identification of the contents of a piping system shall be by lettered legend giving the name of the contents. Arrows shall be used to indicate the direction of flow. Legends shall be applied close to valves, adjacent to changes in direction and branches, where pipes pass through walls and floors, and at frequent intervals on straight pipe runs. The lettering shall be of such color, size, and location so as to be clearly visible and readable.

D. Common division walls between basins or conduits containing nonpotable water and potable water are prohibited. Vertical double division walls, where separated sufficiently to permit ready access for inspection, are permissible where the division walls are monolithic in construction and are properly keyed into their footings or are cast monolithically with their footings.

E. Shop space and storage facilities shall be provided.

F. Wherever pipes pass through walls of concrete structures, extra wall castings to facilitate expansion and future uses shall be provided.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-007.09 § 3.9, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-725 Automated monitoring and control systems

The design of computers, including supervisory control and data acquisition (SCADA) systems if used to monitor and control water treatment and distribution system facilities, shall meet the following general requirements:

1. Data security.

a. Automated systems used to display and record data or control functions that are connected to the internet shall be secure.

b. Backup power supply shall be provided to allow orderly shutdown of the computer system and prevent corruption of data. The protection shall also power associated communications equipment.

c. Adequate hardware shall be in place to allow a high degree of SCADA and computer system reliability and data security.

d. Adequate hardware and associated facilities shall be provided for data archiving.

2. Equipment protection. SCADA and computer systems shall have adequate protection from voltage surges and spikes on the power supply, external data links, and environmental conditions.

3. Data displaying and recording.

a. SCADA and computer systems used to meet the continuous recording requirements of this chapter shall record an observation on a minimum frequency of once per 15 minutes, unless a greater recording frequency is required.

b. SCADA and computer systems used to meet the indicating and recording requirements of this chapter shall provide displays that show a minimum 24-hour trend of results for each parameter. The display panel shall be located in an area where it can be routinely viewed by the waterworks operators.

c. SCADA and computer systems used to meet the indicating and recording requirements of this chapter shall monitor the values and provide alerts for the operator by visual display and audible alarms. Alarm conditions shall be recorded into an alarm log.

4. Waterworks pumps, chemical feeders, and other essential electrical equipment controlled through a SCADA or an automated control system shall have the capability for independent manual operation. Where a high degree of reliability is required, a backup control system shall be provided.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-730 Alternate power sources

A. An emergency management plan for extended power outages shall be developed for each community waterworks as specified in 12VAC5-590-505.

B. Alternative power sources at all waterworks shall be considered in the design to maintain a minimum level of service during an electrical power outage.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-007.10 § 3.10, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-740 (Repealed.)

History

• Historical Notes: Derived from VR355-18-007.11 § 3.11, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-750 (Repealed.)

History

• Historical Notes: Derived from VR355-18-007.12 § 3.12, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-760 Laboratory facilities

A. The design of laboratory facilities shall be compatible with the equipment provided, the water supply, and the design and complexity of the water treatment.

B. The design of community waterworks and NTNCs shall provide for adequate floor and bench space, adequate ventilation, adequate light, adequate separation of incompatible activities, adequate environmental controls, and auxiliary facilities sufficient to carry out reliable testing.

C. Certified analytical laboratory facilities analyzing drinking water shall comply with 1VAC30-41.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-007.13 § 3.13, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-770 Sampling and monitoring equipment

A. Sample taps shall be provided so that water samples can be obtained from each source water and each entry point to the distribution system. At waterworks providing treatment, sample taps shall be provided at the entrance and exit of each unit treatment process and at the entry point to the distribution system.

1. For surface water treatment plants, a master control sink shall monitor source water, chemically treated water, settled water, combined filter water, and at the entry point to the distribution system.

2. All sample taps shall discharge in the downward direction and be provided with a suitable air gap to prevent cross-connection.

B. Continuous monitoring instrumentation shall have electronic sensors that continuously read the parameter and shall display results in real time. Continuous recording equipment shall be provided with the monitoring instrument to store in memory or print one data point at least every 15 minutes. Each result shall be a single result at that time; if signal averaging is applied, the averaging period shall not exceed 30 seconds. The recording equipment shall be capable of producing a paper copy or equivalent electronic file showing daily trends, including maximum, minimum, and average values.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-007.14 § 3.14, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-780 (Repealed.)

History

• Historical Notes: Derived from VR355-18-007.15 § 3.15, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-790 Process water

Process water shall be taken from the finished water. An approved backflow prevention assembly or device shall be installed on the process water supply pipe before connection to the treatment process or equipment.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-007.16 § 3.16, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993.

12VAC5-590-800 (Repealed.)

History

• Historical Notes: Derived from VR355-18-007.17 § 3.17, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-810 Components, materials, and products

All components, materials, and products that will be in contact with source water, partially treated water, finished water, or water treatment chemicals shall comply with NSF/ANSI/CAN Standard 61-2020.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-007.18 § 3.18, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

Article 2 Source Development [Repealed]

12VAC5-590-820 New source water selection and sampling

A. Preference shall be given to the best available sources of supply that present minimal risks of contamination from point and nonpoint pollution sources that contain a minimum of impurities that may be hazardous to health and that give the greatest potential of ensuring a sufficient quantity of potable water.

B. In all cases, sources shall be selected and maintained on a basis that will assure that the water is continuously amenable to available treatment processes. In selecting the source of water to be developed, the owner shall prove to the satisfaction of the department that the water to be delivered to the consumers will comply with 12VAC5-590-340.

C. All water samples for bacteriological, chemical, physical, and radiological analyses shall be submitted to the DCLS or to a testing laboratory certified by the DCLS. Analytical methods shall be in accordance with 12VAC5-590-440.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-008.01 § 3.19, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 22, Issue 24, eff. September 6, 2006.

12VAC5-590-830 Surface water sources; quantity; quality; development structures

A. A surface water source includes all tributary streams and drainage basins, natural lakes, and artificial reservoirs or impoundments above the point of water supply intake.

1. The quantity of water at the source shall:

a. Be adequate to supply the water demand of the service area;

b. Provide a reasonable surplus for anticipated growth; and

c. Be adequate to compensate for all losses, including evaporation, seepage, flow-by requirements, etc.

2. The safe yield of the source shall be determined as follows:

a. Simple intake (free-flowing stream). The safe yield is defined as the minimum withdrawal rate available during a day and recurring every 30 years (30 year - one day low flow). To generate the report for this, data is to be used to illustrate the worst drought of record in Virginia since 1930. If actual gauge records are not available for this, gauges are to be correlated from similar watersheds and numbers are to be synthesized; and

b. Complex intake (impoundments in conjunction with streams). The safe yield is defined as the minimum withdrawal rate available to withstand the worst drought of record in Virginia since 1930. If actual gauge records are not available, correlation is to be made with a similar watershed and numbers synthesized in order to develop the report.

Note: Local governments may request this aid from the State Water Control Board (SWCB) by contacting either the Health Department's Office of Water Programs or the SWCB's headquarters office in Richmond.

B. The owner shall conduct, or have conducted, a sanitary survey and a study of the factors, both natural and man-made, which will affect the quality of the water at the source. The results of the sanitary survey shall be submitted to the division. Such survey and study shall include, but shall not be limited to:

1. Obtaining samples over a sufficient period of time to assess the bacteriological, physical, chemical, and radiological characteristics of the water;

2. Determining future uses and effects of impoundments or reservoirs;

3. Determining the degree of control over the watershed that may be exercised by the owner; and

4. Assessing degree of hazard to the source by possible spillage of materials that may be toxic, harmful, or detrimental to treatment processes.

C. Intake structures shall provide for:

1. Withdrawal of water from at least three levels in impoundments or reservoirs. Withdrawal of water from more than one level may be required in run-of-the stream intakes if the quality varies with depth;

2. Separate facilities for release of less desirable water held in storage;

3. Screens on intake ports with provisions for adequate cleaning;

4. Prevention of flooding of access walkways and control valves of intakes on multiple purpose reservoirs; and

5. Velocity of flow through inlet structure such that frazil ice will be held to a minimum.

D. A detention reservoir is a structure into which water is stored for pretreatment to improve water quality prior to other treatment. Where a detention reservoir is required, the development shall assure that:

1. Water quality is protected by controlling runoff into reservoir;

2. Dikes are structurally sound and protected against wind action and erosion;

3. Point of influent flow is separated from the point of withdrawal; and

4. Sufficient detention time is provided in the reservoir as recommended by the designer and approved by the division.

E. In order to protect the public health and guarantee a supply of pure water, terminal reservoirs shall not be utilized for body contact recreation and boats powered by gasoline engines. Large terminal reservoirs may be used for body contact recreation and boats powered by gasoline engines provided a buffer zone acceptable to the division and water purveyor is furnished. Site preparation shall include but not be limited to the removal of brush and trees to the high water elevation, and protection from floods during construction.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-008.02 § 3.20, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993.

12VAC5-590-840 Groundwater sources

A. A groundwater source includes all water obtained from drilled wells and springs. Wells and springs shall be protected from contamination during construction. All wells intended to serve a waterworks shall be constructed by a certified water well system provider. All wells shall be constructed in a manner to protect groundwater resources by preventing contaminated water or water having undesirable physical, chemical, or radiological characteristics from entering aquifers.

B. All wells located within the Eastern Virginia or the Eastern Shore Groundwater Management Areas shall be constructed in a manner to protect groundwater resources by preventing blending or cross contamination of the aquifers.

1. Wells shall not be constructed with screens in multiple aquifers.

2. Geophysical logging and formation sampling shall be required for all wells during construction, in addition to submitting a Uniform Water Well Completion Report, Form GW-2.

3. Observation and production wells shall be constructed with gravel packs and grout in a manner that prevents movement between aquifers. Gravel pack shall be terminated close to the top of the well screens and shall not extend above the top of the screened aquifer. The remainder of the annular space shall be filled with grout material.

4. Pump intake setting shall be documented and the pump intake shall not be set below the top of a confined aquifer or the bottom of an unconfined aquifer that supplies water to the well.

C. All groundwater sources must be analyzed for chemical, physical, radiological, and bacteriological quality as described in 12VAC5-590-840 K.

D. Wells intended for use as a community waterworks shall be located on a well lot meeting the following minimum requirements:

1. The well lot shall provide a distance of at least 50 feet from the well to all property lines;

2. The owner shall consider the need for a larger well lot for future expansion, the need to provide security measures such as lot fencing, and the need to establish additional well lots for future use;

3. If the well lot does not adjoin a public road, then an access road shall be provided and an access easement recorded as part of the well lot;

4. The well lot shall be graded to divert surface runoff away from the well and to prevent ponding on the well lot; and

5. The well lot and access to the lot shall be located by a survey, and a final plat plan and dedication document prepared and recorded as described in 12VAC5-590-200.

E. Minimum well location requirements:

1. The horizontal distance from the well to any septic tank, sanitary drainfield, pit privy, cesspool, barnyard, animal feed lot, cemetery, geothermal well or source of similar contamination, and all surface runoff from actual or potential sources of contamination shall be at least 50 feet.

2. The horizontal distances from the well to any pipe carrying sewage or pipe in which sewage can back up shall be at least 50 feet.

3. A minimum separation distance of 50 feet shall be maintained between a fuel storage tank and a well; however, a lesser distance may be allowed if the fuel is propane or natural gas, or if it is liquid fuel meeting the following requirements:

a. Liquid fuel tanks shall be located above grade.

b. Liquid fuel tanks shall be double-walled with an inner wall leak-detection alarm or single-walled with a full-capacity containment system constructed of compatible material.

c. Liquid fuel lines shall be located above grade or enclosed in a protective casing if below grade, and liquid fuel tanks shall be provided with a paved and curbed parking pad at the tank filling location.

4. The department shall require a spill response plan if the fuel is stored within 50 feet of the well.

F. The class of well to be constructed shall be determined by the department. A Uniform Water Well Completion Report, Form GW-2, shall be completed and submitted to the department with the project documents, in accordance with procedures in 12VAC5-590-200.

1. Minimum construction requirements for Class I wells:

a. The well shall be drilled and cased to a depth sufficient to exclude undesirable groundwater, but in no case shall this depth be less than 100 feet below finished grade.

b. The diameter of the drill hole shall be at least three inches greater than the outside diameter of the couplings of the casing to be used.

c. For wells constructed in consolidated formations, the lower end of the casing shall terminate in solid rock or other impervious formation when practical to do so.

d. The annular space around the casing shall be grouted to a depth of at least 100 feet in a manner satisfactory to the department. When the outer casing cannot be removed, the annular spacing between the drill hole and the outer casing shall also be sealed in a manner approved by the department.

2. Minimum construction requirements for Class II wells.

a. The well shall be drilled and cased to a depth sufficient to exclude undesirable groundwater, but in no case shall this depth be less than 50 feet below finished grade.

b. The diameter of the drill hole shall be at least three inches greater than the outside diameter of the couplings of the casing to be used.

c. For wells constructed in consolidated formations, the lower end of the enlarged portion of the drill hole should terminate in solid rock or other impervious formation when practical to do so.

d. The annular space around the casing shall be grouted to a depth of at least 50 feet in a manner satisfactory to the department. When the outer casing cannot be removed, the annular spacing between the drill hole and the outer casing shall be sealed in a manner approved by the department.

G. Well construction materials and development.

1. Water used in well construction shall be from a potable water source or from the well under construction.

2. Casing and liner pipe.

a. Steel casing and liner pipe shall meet ASTM, NSF/ANSI/CAN, or AWWA specifications and standards applicable to wells. Steel pipe dimensions shall conform to Table 840.1.

| TABLE 840.1 Steel Well Casing Pipe | | | | | | | --- | --- | --- | --- | --- | --- | | STEEL PIPES | | | | | | | SIZE (inches) | DIAMETER (inches) | THICKNESS (inches) | WEIGHT PER FOOT (pounds) | | | | | External | Internal | | Plain Ends | With Threads and Couplings | | 4 | 4.5 | 4.026 | 0.237 | 10.79 | 11.0 | | 6 | 6.625 | 6.065 | 0.280 | 18.97 | 19.18 | | 8 | 8.625 | 7.981 | 0.322 | 28.55 | 29.35 | | 10 | 10.750 | 10.020 | 0.365 | 40.48 | 41.85 | | 12 | 12.750 | 12.000 | 0.375 | 49.56 | 51.15 | | 14 | 14.000 | 13.250 | 0.375 | 54.57 | 57.00 | | 16 | 16.000 | 15.250 | 0.375 | 62.58 | | | 18 | 18.000 | 17.250 | 0.375 | 70.59 | | | 20 | 20.000 | 19.250 | 0.375 | 78.60 | | | 22 | 22.000 | 21.000 | 0.500 | 114.81 | | | 24 | 24.000 | 23.000 | 0.500 | 125.49 | | | 26 | 26.000 | 25.000 | 0.500 | 136.17 | | | 28 | 28.000 | 27.000 | 0.500 | 146.85 | | | 30 | 30.000 | 29.000 | 0.500 | 157.53 | | | 32 | 32.000 | 31.000 | 0.500 | 168.21 | | | 34 | 34.000 | 33.000 | 0.500 | 178.89 | | | 36 | 36.000 | 35.000 | 0.500 | 189.57 | |

b. Plastic well casing shall be PVC meeting ASTM F480-14,, NSF/ANSI/CAN Standard 61-2020, or AWWA Standard A100-20. Depths shall not exceed the published resistance to hydraulic collapse pressure of the PVC casing, taking into account the installation techniques and grouting methods. Well casing wall thickness shall be sufficient to withstand anticipated formation and hydrostatic pressures and mechanical forces imposed during installation, well development, and use. PVC well casing shall meet the requirements of ASTM, NSF/ANSI/CAN, and AWWA, as applicable.

| | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| | | | --- | --- | | | | | | | | | | | | | | | | | | |

c. Heavyweight casing pipe may be required under certain geologic and hydrostatic conditions.

d. Where corrosive conditions exist, materials such as coated casings, stainless steel, bronze, or plastic may be used as casings or linings subject to approval by the department, and meeting the requirements of NSF/ANSI/CAN Standard 61-2020.

3. Packers or other well construction materials shall be of a material that will not impart taste, odors, toxic substances, or bacterial contamination to the water in the well. No lead is to be used in packers, flux, piping, etc.

4. Screens, where required, shall:

a. Be constructed of material that will not be damaged by chemical action of groundwater or future cleaning operations;

b. Have size of openings to be based on sieve analysis of the formation to be screened, and shall be adequate to pass flows at a velocity of 0.1 ft/sec or less; and

c. Be installed so that exposure above the pumping level will not occur.

5. Grouting requirements.

a. Neat cement grout shall consist of Portland cement and water with not more than six gallons of water per 94-pound sack of cement, and shall be in place within 48 hours of well construction. A maximum of 6.0%, by weight, bentonite and 2.0%, by weight, calcium chloride, may be added. Other grout mixes may be approved by the department where special conditions warrant.

b. Application.

(1) Grout shall be installed by means of continuous pressure grouting from the bottom of the annular opening upward in one continuous operation until the annular opening is filled.

(2) Sufficient annular opening shall be provided to permit a minimum of 1-1/2 inches of grout around the protective casing, including couplings, if used.

(3) Before grouting wells, suitable fill material such as bentonite, low-strength cement and sand mix, or similar materials that have been approved by the department shall be added to the annular opening below the grout zone to seal and stabilize these areas. Instead of this requirement, the casing may be grouted for its entire depth.

c. Casing shall be provided with sufficient centralizers attached to the casing to allow unobstructed flow and uniform thickness of the grout.

d. Where plastic well casing is used, the heat of hydration of cement mixtures and the hydraulic collapse pressure of the casing shall be taken into consideration when choosing grout composition and placement in accordance with DEQ guidelines.

6. To prevent tampering and contamination of the source water, unused wells shall be capped and locked. Watertight welded metal plates, set screw caps, or screw-on caps are acceptable for temporarily capping a well until the pumping equipment is installed.

H. A well yield and drawdown test shall be performed in accordance with requirements of this subsection. The department may require additional pumping wells, observation wells, or longer duration tests where site conditions warrant.

1. The yield and drawdown test duration shall be a minimum of 48 hours. Data to be collected during the yield and drawdown test shall be recorded on the Well Yield and Recovery Report form provided by the department. When the source water requirements for a noncommunity waterworks are determined to be three gpm or less over normal hours of operation, the 48-hour minimum drawdown test may be reduced to no less than 12 hours. Any reduction shall be approved by the department before conducting the test.

2. Discharge from the pumping well shall be conveyed away from the test site to avoid recharge.

3. Where multiple wells are intended to be used, the location and geology of each well in the vicinity shall be evaluated. The department shall require that:

a. The yield and drawdown test be performed simultaneously on the multiple wells, or

b. During the yield and drawdown test of the pumping well, the water levels of the neighboring wells shall be monitored. If the water level of the neighboring wells declines in response to the pumping well, then additional evaluation shall be required by a professional engineer or a professional geologist with experience in groundwater source evaluations.

4. The department may consider alternative testing methods and analyses as proposed by professional engineers or professional geologists with experience in groundwater source evaluations. Where geological conditions exist that prohibit an accurate determination of well yield using methods prescribed in this subsection, additional testing procedures shall be required on an individual basis and approved by the department.

5. When an aquifer test is required by DEQ for a well located in a GWMA, the yield and drawdown test may be incorporated into the aquifer test plan protocol if approved by the department before conducting the test.

I. Well appurtenances.

1. A sanitary seal shall be provided on the top of the well casing, or a watertight well cap shall be provided when a pitless adapter is installed.

2. The well casing shall extend at least 12 inches above the concrete floor or apron.

3. Where aprons are used, they shall be centered on the well and measure at least six feet by six feet by six inches thick.

4. Provisions shall be made for venting the well casing to the atmosphere. Where vertical turbine pumps are used, vents into the side of the casing may be necessary to provide adequate venting.

5. Each well casing shall be provided with equipment and appurtenances for measuring the water level elevation in the well. Corrosion-resistant materials shall be used. Where necessary, the appurtenances shall be attached firmly to the drop pipe or pump column and in a manner as to prevent entrance of foreign materials.

6. All pitless well units, adapters, and watertight caps shall be listed by the Water Systems Council as certified products, or as approved by the department.

J. Every new, modified, or reconditioned groundwater well or spring shall be disinfected after placement of the final pumping equipment. Wells shall be disinfected in accordance with AWWA Standard C654-13.

K. Water quality tests. Water quality sampling and analysis shall be conducted for every new, modified, or reconditioned well or spring to determine what treatment, if any, is required. All samples shall be analyzed by DCLS or a testing laboratory certified by DCLS. Water quality analytical methods shall conform to requirements contained in 12VAC5-590-440.

1. Bacteriological quality.

a. Bacteriological samples for new or deepened wells shall consist of a series of 20 samples collected at a minimum of 30-minute intervals during the last 10 hours of the yield and drawdown test. These samples shall be analyzed for both total coliform density and E. coli density. See 12VAC5-590-380 G for groundwater disinfection treatment requirements, and see 12VAC5-590-430 for surface water influence determinations.

b. Bacteriological samples for modified or reconditioned wells shall consist of two samples collected at least 30 minutes apart, at a minimum, while the pump is in continuous operation. These samples shall be analyzed for both total coliform density and E. coli density. More samples may be required by the department, depending on the work performed.

2. Samples for new wells shall be collected for chemical, physical, and radiological contaminants listed in Tables 340.1 through 340.4. SOC tests may be waived by the department if supported by the source water assessment of vulnerability to contamination. Chemical sampling analysis for a TNC may be limited to nitrate and nitrite only. Samples shall be collected at the end of the yield and drawdown test and after the well water has shown no further change in the clarity of the water. Chemical, physical, and radiological constituent testing for modified or reconditioned wells shall be determined on an individual basis by the department.

L. Observation wells:

1. Shall be constructed in accordance with the requirements of DEQ if they are constructed in a GWMA. Otherwise, they shall be constructed in accordance with 12VAC5-630-420 if they are to remain in service as observation wells after completion of the groundwater study.

2. Shall be protected to preclude the entrance of contamination.

M. Sealing of select zones. All zones containing water of undesirable quality or zones to be protected but excluded from final well completion shall be grouted from a point at least five feet above the zone to a point at least five feet below the zone.

N. Gravel packed wells:

1. The gravel utilized shall be free of foreign material, properly sized, washed, and then disinfected before or during placement.

2. The gravel refill pipes, when used, shall be incorporated within the pump foundation or concrete apron and terminated with screwed or welded caps at least 12 inches above the pump house floor or concrete apron.

3. The gravel refill pipes in the grouted annular opening shall be surrounded by a minimum of 1-1/2 inches of grout.

4. A means for the prevention of leakage of grout into the gravel pack of the screen shall be provided.

5. The minimum protective casing and grouted depth shall be acceptable to the department.

6. Wells located in a GWMA shall have gravel packing installed in accordance with 12VAC5-590-840 B 3.

O. Radial water collector systems shall be considered on an individual basis by the department.

P. Flowing artesian wells located outside a GWMA will be considered on an individual basis by the department.

1. The well shall be equipped with a pitless adapter specifically designed for pressurized artesian wells.

2. Special well construction, casing, and sealing may need to be considered for flowing artesian wells.

Q. Capacity determination of wells used for community waterworks shall meet the daily water demand.

1. Capacity of wells located in consolidated rock formations shall be determined by the well sustainable yield, and the actual installed (production) well pump capacity, whichever value is less. The sustainable yield shall be calculated as follows:

(A x 1440 min/day) / 1.8 = gpd well sustainable yield, where A = well yield (gpm) determined by the yield and drawdown test conducted in accordance with 12VAC5-590-840 H.

2. Capacity of wells located in unconsolidated formations shall be determined by the well yield and the actual installed (production) well pump capacity, whichever value is less.

R. Waterworks serving 50 or more residential connections employing only wells providing the source water shall include at least two wells. If only two wells are provided, then the second well shall be rated for at least 30% of the waterworks permit capacity.

S. The owner of a waterworks serving fewer than 50 residential connections with a single well providing the source water shall provide or have ready access to a replacement pump and other components and materials needed for pump replacement. Instead of this requirement, the owner may provide 48 hours of total finished water storage volume based on the maximum daily water demand.

T. Springs.

1. The water quality of spring sources shall be established by obtaining samples over a period of time agreeable to the department to assess the bacteriological, physical, chemical, and radiological characteristics.

2. Springs shall be housed in a permanent structure and protected from entry of surface water.

3. The amount of land required for protection of the spring source shall be determined by the owner and approved by the department.

4. The design of spring sources shall provide for continuous disinfection.

5. The capacity of spring sources shall be determined using actual flow data.

a. Sufficient daily flow data shall be collected to conduct a frequency distribution analysis. The capacity of a spring source is defined as the low flow rate for one day with a projected recurrence period of 30 years (i.e., 30-year, one-day low flow).

b. The Log-Pearson Type III method of frequency distribution analysis shall be used to make the determination, with a minimum of 1,000 daily flow measurements.

c. If sufficient data is not available to conduct the analysis specified in this subsection, then the lowest recorded daily flow rate may be considered to be the spring capacity. Sufficient flow records shall be available to capture the spring flow during drought conditions, and shall be acceptable to the department.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-008.03 § 3.21, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993.</p.

Article 3 Processes and Devices [Repealed]

12VAC5-590-850 Appropriate treatment

A. The design of water treatment facilities shall depend upon the evaluation of the nature and quality of the particular source water to be treated and the required quality of the finished water. Treatment process selection shall follow the requirements of 12VAC5-590-680.

B. The design of water treatment facilities shall address safety considerations as required in 12VAC5-590-560.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-009.01 § 3.22, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-860 Chemical application

A. Plans and specifications shall be submitted for evaluation and approval, as required in Part I (12VAC5-590-200 through 12VAC5-590-220), and shall include:

1. Descriptions of feed equipment, including maximum and minimum feed ranges;

2. Location of feeders, piping layout, and points of application;

3. Chemical storage and handling facilities;

4. Specifications for chemicals to be used;

5. Operating and control features; and

6. Descriptions of testing equipment and procedures.

B. Chemicals shall be applied to the water at such points and by such means as to:

1. Assure maximum efficiency of treatment;

2. Provide maximum protection to the consumer;

3. Provide maximum safety to operators;

4. Assure satisfactory mixing of the chemicals with the water;

5. Provide maximum flexibility of operation through various points of application, when appropriate;

6. Prevent backflow or backsiphonage between multiple points of feed through common manifolds; and

7. Provide for the application of pH-affecting chemicals to the source water before the addition of the coagulant in turbidity removal processes.

C. Feed equipment.

1. Where chemical feed is necessary for the treatment of the source water, such as chlorination, coagulation, or other essential processes, a standby feeder or combination of feeders shall be available to provide the required chemical dose with the largest feeder out of service.

2. Feeders shall be of such design and capacity to meet the following requirements:

a. Feeders shall be able to supply the necessary amounts of chemical at an accurate rate throughout the range of feed at all times.

b. Proportioning of chemical feed to the rate of flow shall be provided where the water flow is not constant or where specifically required by the department.

c. Positive displacement type solution feed pumps, or gravity feed through rotameters, shall be used to feed liquid chemicals, but should not normally be used to feed chemical slurries.

d. Chemical contact materials and surfaces shall be resistant to the aggressiveness of the chemical solution.

e. Dry chemical feeders shall:

(1) Measure chemicals volumetrically or gravimetrically;

(2) Provide effective solution of the chemical in the solution pot;

(3) Provide gravity feed from solution pots; and

(4) Completely enclose chemicals to prevent emission of dust to the room.

f. No direct connection shall exist between any sewer and a drain or overflow from the feeder or solution chamber or tank.

g. A separate chemical waste tank should be considered.

3. Chemical feed equipment:

a. Shall be located near points of application to minimize length of feed lines;

b. Shall be readily accessible for servicing and repair, and observation of operation; and

c. Shall be located within a protective curbing so that chemicals resulting from equipment failure, spillage, or accidental drainage shall not enter the water in conduits or treatment or storage basins.

4. Control.

a. Feeders shall be capable of both manual and automatic control with the automatic control reverting to manual control as necessary;

b. Feeders shall be manually started following shutdown, unless otherwise approved by the department; and

c. Automatic chemical dose controls with residual analyzers shall provide alarms for critical values and shall include indicating and recording equipment.

5. Solution tanks. All solution tanks shall be manufactured of materials suitable for food contact or that meet the requirements of 12VAC5-590-810.

a. Means shall be provided to maintain uniform strength of solution, consistent with the nature of the chemical solution. Continuous agitation shall be provided to maintain slurries in suspension.

b. Solution tanks shall be of sufficient number and capacity to assure continuous chemical application during tank servicing, and the access openings shall be curbed and fitted with tight covers.

c. Each tank exceeding 30 gallons in capacity or fixed in place shall be provided with a drain unless other means of dewatering the tank are provided.

(1) Direct connection between any tank or drain and a sewer is prohibited.

(2) All drains shall terminate at least two pipe diameters, but not less than two inches, above the rim of the receiving sump, conduit, or waste receptacle.

d. Means shall be provided to indicate the solution level in the tank.

e. Process water shall enter the tank above the rim at a distance of two pipe diameters but not less than two inches.

f. Chemical solutions shall be kept covered.

g. Buried or subsurface chemical storage or solution tanks are prohibited.

h. Overflow pipes, when provided, shall:

(1) Be turned downward, and when located outside, be provided with an appropriately sized screened end to prevent entry of insects and small animals;

(2) Have free discharge;

(3) Be located where noticeable; and

(4) Be directed so as not to contaminate the water or be a hazard to operating personnel.

6. Weighing scales.

a. Shall be provided for weighing cylinders at all water treatment plants utilizing chlorine gas; for large water treatment plants, indicating and recording type are desirable;

b. Shall be provided for fluorosilicic acid feed systems in conjunction with a loss-of-weight recorder;

c. Shall be considered for volumetric dry chemical feeders; and

d. Shall be accurate to measure increments of 0.5% of load.

7. Feed lines.

a. Shall be as short as possible in length of run and be:

(1) Of durable, corrosion-resistant material;

(2) Easily accessible throughout the entire length;

(3) Protected against freezing; and

(4) Readily cleanable;

b. Shall slope upward from chemical source to feeder, when conveying gases.

c. Shall introduce corrosive chemicals in a manner as to minimize potential for corrosion.

d. Shall be designed consistent with scale forming solids depositing properties of the water, chemical solution, or mixture conveyed.

e. Shall not carry chlorine gas beyond the chlorine feeder room unless the chlorine is under vacuum.

f. Shall be designed so that liquid alum does not mix with water before the point of application.

8. Process water.

a. Water used for dissolving dry chemicals, diluting liquid chemicals, or operating chemical feeders shall be:

(1) From a safe, approved source;

(2) Protected from contamination by appropriate means;

(3) Ample in supply and adequate in pressure;

(4) Provided with means for measurement when preparing specific solution concentrations by dilution; and

(5) Properly treated for hardness when necessary.

b. Where a booster pump is required, a spare pump shall be provided.

c. Backflow prevention shall be achieved by appropriate means such as:

(1) An air gap between the fill pipe and overflow rim of the solution or dissolving tank, and equivalent to two pipe diameters but not less than two inches;

(2) An approved reduced pressure zone backflow preventer, consistent with the degree of hazard, aggressiveness of chemical solution, back pressure sustained, location, and available means for maintaining and testing the device; or

(3) A satisfactory vacuum relief device.

D. Chemicals.

1. Storage.

a. Space shall be provided where at least 30 days of chemical supply can be stored, based on the average dose and average annual water treatment plant flow rate. Storage shall be at a location that is convenient for efficient handling and safety. Lesser storage capacity may be approved if the owner can demonstrate that the local suppliers or other conditions will provide an uninterrupted source of chemicals.

b. Cylinders of chlorine gas shall be:

(1) Isolated from operating areas;

(2) Restrained in position to prevent upset; and

(3) Stored in rooms separate from ammonia storage.

c. Liquid chemical storage tanks shall:

(1) Have a liquid level indicator; and

(2) Have an overflow and a receiving basin or drain capable of receiving accidental spills or overflows.

d. Special precautions shall be taken with sodium chlorite to eliminate any danger of explosion.

e. Activated carbon. The following special precautions shall be taken in areas where activated carbon is stored, handled, and fed.

(1) Isolated, cool, and dry areas free from sources of ignition shall be provided for activated carbon storage;

(2) Electrical equipment, devices, and materials shall comply with applicable codes;

(3) Ventilation in areas associated with the storage, handling, and feeding of activated carbon shall be localized so as not to cause dust or material to be drawn into other areas; and

(4) Activated carbon shall not be stored with strong oxidants such as ozone, liquid chlorine (i.e., compressed chlorine gas), and permanganate.

f. Chemicals shall be stored in covered or unopened shipping containers, unless the chemical is transferred into an approved covered storage unit.

g. Solution storage or day tanks supplying feeders directly should have sufficient capacity for one day of operation.

h. Acid storage tanks shall be vented to the outside atmosphere, but not through vents in common with day tanks.

2. Handling.

a. Provisions shall be made for measuring quantities of chemicals used to prepare feed solutions.

b. Storage tanks and pipelines for liquid chemicals shall be specific to the chemicals and not for alternates.

c. Chemicals that are incompatible shall not be fed, stored, or handled together.

d. Provisions shall be made for the proper transfer of dry chemicals from shipping containers to storage bins or hoppers to mitigate the quantity of dust that may enter the room in which the equipment is installed. Control shall be provided by use of:

(1) Vacuum pneumatic equipment or closed conveyor systems;

(2) Facilities for emptying shipping containers in special enclosures; or

(3) Exhaust fans and dust filters that put the hoppers or bins under negative pressure.

e. Precautions shall be taken with electrical equipment to prevent explosions and other hazards.

f. Acids shall:

(1) Be kept in closed, acid-resistant shipping containers or storage units; and

(2) Not be handled in open vessels, but should be pumped in undiluted form from original containers, through a suitable hose, to the point of treatment or to a covered day tank.

g. Carts, elevators, and other appropriate means shall be provided for lifting chemical containers to mitigate excessive lifting by operators.

h. Provisions shall be made for disposing of empty containers by an approved procedure that will mitigate exposure to the chemical.

E. Housing.

1. Structures, rooms, and areas accommodating chemical feed equipment shall provide convenient access for servicing, repair, and observation of operation.

2. Floor surfaces shall be smooth and impervious, slip-proof, and well drained.

3. Open basins, tanks, and conduits shall be protected from chemical spills or accidental drainage.

F. Operator safety. Safety provisions shall protect people at the waterworks from chemical exposures in accordance with VOSH laws and regulations.

1. Gases from feeders, storage, and equipment exhausts shall be conveyed to the outside atmosphere, above grade, and remote from air intakes.

2. See 12VAC5-590-1000 and 12VAC5-590-1001 for special provisions for handling and storing chlorine.

3. A plastic bottle of hydrochloric acid (muriatic acid in commercial form) shall be available for ammonia leak detection where ammonia gas is used or stored.

4. At least one pair of rubber gloves with long gauntlets, a dust respirator of a type that complies with VOSH laws and regulations for toxic dusts, and an apron or other protective clothing shall be provided for each operator in any shift who will handle dry chemicals.

5. Facilities such as emergency eye wash and showers shall be provided for washing of the face, gloves, and protective equipment.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-009.02 § 3.23, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-865 Conventional filtration treatment

A. Conventional filtration treatment is generally used for surface water sources. It is defined as a series of four processes: coagulation, flocculation, sedimentation, and filtration. The specific design parameters shall consider the water supply characteristics and variability in quality due to seasonal and climatic events.

B. Conventional filtration treatment plants shall provide staged, multiple treatment process units to allow individual units to be taken out of service without disrupting operation.

C. The department may require presedimentation of waters containing high turbidity or organics (as measured by TOC).

1. Presedimentation basins utilizing a coagulant feed shall have hoppered bottoms or shall be provided with continuous sludge removal equipment. The minimum hydraulic detention time shall be three hours. The department may require greater detention times depending on the source water quality and the level of pretreatment required.

2. Presedimentation basins without coagulant feed shall provide a minimum hydraulic detention time of 24 hours. The design shall address future needs for solids removal and handling.

3. Incoming water shall be dispersed across the full width of the line of travel as quickly as possible. Short circuiting shall be minimized. The department may require baffling on large basins.

4. Provisions for bypassing presedimentation basins shall be provided.

5. Surface runoff shall be prevented from entering presedimentation basins or reservoirs.

6. Dikes shall be structurally sound and protected against wind action and erosion.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-870 (Repealed.)

History

• Historical Notes: Derived from VR355-18-009.03 § 3.24, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-871 Coagulation and flocculation

A. Rapid mixing is the rapid dispersion of chemicals throughout the water to be treated, usually by violent agitation, to promote coagulation.

1. Rapid mix basins or inline static mixers shall be provided.

2. Basins shall be equipped with mechanical mixing devices. Other arrangements, such as baffling, may be acceptable under special conditions and only when approved by the department. Where mechanical mixing devices are utilized, duplicate units or spare mixing equipment shall be provided.

3. Rapid mix basins with mechanical mixers should be based upon the mean temporal velocity gradient "G" (expressed as units of seconds^-1). The owner's engineer shall submit the basis for the selected velocity gradient considering the chemicals to be added and water temperature. Typical values for G and T are:

| TABLE 871.1 Rapid Mix Basin GT Values | | | --- | --- | | T (seconds) | G (seconds^-1) | | 20 | 1,000 | | 30 | 900 | | 40 | 700 | | 60 | 600 |

a. The point of application of the coagulant shall be at the point of maximum mixing intensity;

b. The physical configuration of the mixing basin shall be designed to eliminate vortexing; and

c. Mechanical mixers should be designed to allow speed variation with a highest speed of at least three times the lowest speed.

B. Flocculation mixing is the agitation of treated water at low velocity gradients for sufficient time to agglomerate coagulated particles.

1. Basin inlet and outlet design shall prevent short circuiting and destruction of floc. A drain and overflow shall be provided. Multiple units shall be provided for continuous operability, and each basin shall be designed so that individual basins may be isolated without disrupting plant operation. Basins shall be arranged to allow for either series or parallel operation.

2. Design parameters:

a. The minimum detention time shall be 30 minutes for water treatment plants employing rapid rate gravity filters, and 20 minutes for water treatment plants using high rate gravity filters. Basin flow-through velocity should not be less than 0.5 ft/min or greater than 1.5 ft/min.

b. The design of the flocculation units shall be based upon the value of GT, which is ordinarily in the range of 20,000 to 200,000. The owner's engineer should establish the value of GT through experimentation.

c. Agitators shall be driven by variable speed drive units with peripheral tip speed of the paddles ranging from 0.5 to 3.0 ft/sec.

d. To control short circuiting in mechanical flocculators, at least three successive compartments should be provided. In addition, special attention should be given to the ports between compartments to further suppress short circuiting.

e. To accomplish maximum power input and reduce particle shearing, tapered flocculation should be provided.

f. In basins utilizing vertical shaft flocculators, wing walls, or stators shall be provided to prevent vortexing.

3. Flocculation and sedimentation basins shall be as close together as possible. The velocity gradient of the flocculated water through pipes or conduits to settling basins shall not be greater than the velocity gradient utilized in flocculating the water. Where velocity gradient is not used as a design parameter, the linear velocity in pipes and conduits from the flocculators to the settling basin shall not exceed 0.5 ft/sec unless otherwise approved by the department. Allowances shall be made to minimize turbulence at bends and changes in direction.

4. Baffling may be used for flocculation in small water treatment plants only when approved by the department. The design should allow the velocity gradients noted in subdivision B 3 of this subsection to be maintained.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-872 Sedimentation

A. The water treatment plant capacity, source water quality, and filtration process used shall be considered in determining the number and design of sedimentation basins.

B. The minimum settling time shall be four hours for water treatment plants employing rapid rate gravity filters, and a minimum of three hours for water treatment plants using high rate gravity filters. Reduced settling times may be approved by the department where effective settling is demonstrated. Effective settling time shall be calculated using the volume of the basins from the stilling wall to the submerged effluent orifice or weir, including the volume under launders or finger weirs.

C. Inlets shall be designed to distribute the water equally and at uniform velocities. Open ports, submerged ports, stilling walls, and similar entrance arrangements are required. Port velocities should be in the range of 0.5 to 1.5 ft/sec. Where stilling walls are not provided, a baffle shall be constructed across the basin close to the inlet and shall project several feet below the water surface to dissipate inlet velocities and provide uniform flows across the basin.

D. Outlet weirs or submerged orifices shall be designed to maintain settling velocities in the basin and minimize short circuiting. Outlet weirs and submerged orifices shall be designed as follows:

1. The rate of flow over the outlet weir shall not exceed 20,000 gpd/ft of the outlet launder.

2. Submerged orifices shall not be located lower than three feet below the normal water surface.

3. The entrance velocity through the submerged orifices shall not exceed 0.5 ft/sec.

E. The linear velocity in pipes and conduits from settling basins shall not exceed 1.0 ft/sec.

F. Rectangular sedimentation basins shall be designed with a length-to-width ratio of at least 4:1.

G. Surface overflow rates shall be within the range of 0.25 to 0.38 gpm/ft² in water treatment plants using rapid rate filters, and a maximum of 0.5 gpm/ft² for water treatment plants using high rate filters. Increased surface overflow rates and reduced settling times may be approved by the department where effective settling is demonstrated. The length and area between launders and finger weirs may be included in determining length-to-width ratio and overflow rates.

H. Basins shall be provided with a means for dewatering. Basin bottoms shall slope toward the drain not less than one foot in 12 feet unless mechanical sludge collection equipment is provided.

I. In areas where settling basins are subject to high and frequent cross winds, windbreaks shall be considered. Covers or enclosures shall be considered in locations subject to freezing.

J. The velocity through settling basins shall not exceed 1.0 ft/min. The basins shall be designed to minimize short circuiting. Baffles shall be provided as necessary to minimize short circuiting.

K. Multiple basins shall be provided for continuous operability, and each basin shall be designed so that individual basins may be isolated without disrupting plant operation.

L. Mechanical sludge collecting equipment shall be considered for all plants.

M. Sedimentation basins with tube or plate settlers shall meet the following design requirements:

1. Inlet and outlets shall be designed to maintain velocities suitable for settling in the basin and minimize short circuiting. Plate units shall be designed to ensure even flow distribution across the units.

2. Drain piping from the settler units shall be sized to facilitate a quick flush of the basin and to prevent flooding other portions of the plant.

3. Where units are located outdoors, adequate freeboard shall be provided above the top of the settlers to prevent freezing.

4. The maximum loading for tube settlers shall be two gpm/ft² of cross-sectional area unless higher rates are demonstrated through pilot plant or in-plant demonstration studies.

5. The maximum loading for plate settlers shall be 0.5 gpm/ft² based upon 80% of the projected horizontal plate area.

6. Flushing lines shall be provided to facilitate maintenance and shall be properly protected against backflow or backsiphonage.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-873 Solids contact treatment units

A. Solids contact units shall be acceptable for combined flocculation and clarification where source water characteristics are not variable and flow rates are uniform. When approved, these units shall be designed for the maximum uniform rate and shall be adjustable to changes in flow that are less than the design rate and for changes in water characteristics.

B. A minimum of two units shall be provided.

C. A rapid mix device designed in accordance with 12VAC5-590-871 A shall be provided. Mixing devices shall be constructed to:

1. Provide good mixing of the source water with previously formed sludge particles; and

2. Prevent deposition of solids in the mixing zone.

D. Flocculation equipment designed in accordance with 12VAC5-590-871 B shall:

1. Be equipped with an adjustable drive mechanism;

2. Ensure that coagulation occurs in a separate chamber or baffled zone within the unit; and

3. Provide a flocculation period of at least 20 minutes.

E. The sludge equipment shall provide either internal or external sludge concentrators in order to obtain a concentrated sludge with a minimum of waste water. Sludge removal systems shall provide:

1. Sludge pipe sizes of not less than three inches in diameter;

2. Piping arrangements to prevent clogging and to facilitate cleaning;

3. Valves that are located outside the tank for accessibility;

4. A means to observe or sample sludge being withdrawn from the unit;

5. A time clock with proportional timer with automatic blowoff; and

6. Suitable controls for sludge withdrawal.

F. Cross-connections.

1. Blowoff outlets and drains shall terminate and discharge at a place satisfactory to the department; and

2. Cross-connection control shall be included for the potable water mains used to flush sludge lines.

G. The detention time shall be established on the basis of the source water characteristics and other local conditions that affect the operation of the unit. The minimum detention time shall be two hours for suspended solids contact clarifiers.

H. Orifices shall produce uniform rising rates over the entire area of the tank and shall provide for an exit velocity not to exceed 1.0 ft/sec.

I. Upflow rates shall not exceed 1.0 gpm/ft² of area at the sludge separation line.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-874 Gravity filtration

A. At least two gravity filter units shall be provided in conventional filtration treatment plants and direct filtration treatment plants.

B. Filter loading rates shall not exceed 2.0 gpm/ft² of filter area for rapid rate filters and shall not exceed 4.0 gpm/ft² for high rate filters, during normal operation. Alternative loading rates may be approved by the department when effective filtration is demonstrated.

C. The filter structure shall be so designed as to comply with the following:

1. The walls within the filter shall be vertical;

2. The filter walls shall not protrude into the filter media;

3. There shall be no common wall between filtered or finished water and any lesser quality water;

4. The filter shall be covered by a superstructure if determined necessary under local climatic conditions;

5. There shall be head room to allow normal inspection and operation;

6. A curb at least four inches high shall surround each filter to prevent floor drainage into the filter;

7. The maximum velocity gradient of treated water in pipes and conduits to the filters shall not exceed that used in flocculation. Where velocity gradient is not used as a design parameter, the linear velocity in pipes and conduits from settling basins to filters shall not exceed 1.0 ft/sec;

8. Influent pipes or conduits, where solids loading is heavy, shall be straight and equipped with cleanouts;

9. Backwash water drain capacity shall be sufficient to carry the maximum flow;

10. Access in the form of walkways not less than 24 inches in width shall be provided to each filter; and

11. The normal operating water surface on a filter shall be at the same hydraulic grade level as the sedimentation basin, if no intermediate treatment process is provided.

D. Backwash water troughs shall be so designed as to provide:

1. Bottom elevation of the trough above the maximum level of expanded media during backwashing;

2. At least a two-inch freeboard inside the trough at the maximum rate of wash;

3. A level top or edge;

4. Spacing so that each trough serves an equal area of each filter; and

5. Maximum horizontal travel of suspended particles to reach the trough not to exceed 3.0 ft.

E. Filter media shall be free from detrimental chemical or bacterial contaminants. Acceptable filter media shall include anthracite coal, silica sand, garnet sand, and GAC. Other natural or synthetic media may be approved by the department when pilot-scale or full-scale demonstration studies demonstrate that the media is capable of meeting the filter effluent turbidity treatment technique requirements in Part II (12VAC5-590-395) of this chapter.

1. Filters may be of single media, dual media, or multimedia design depending upon the water to be treated and the specific filtration process employed. A total media depth of not less than 27 inches shall be provided after cleaning and scraping.

2. Types of filter media:

a. Anthracite coal. A sieve analysis shall be provided. Anthracite media shall have:

(1) An effective size from 0.45 to 0.55 mm with a uniformity coefficient not greater than 1.65 when used alone.

(2) An effective size from 0.8 to 1.2 mm with a uniformity coefficient not greater than 1.85 when used in dual or multimedia filters.

b. Silica sand. A sieve analysis shall be provided. The media shall be clean silica sand having an effective size from 0.35 to 0.55 mm and a uniformity coefficient not greater than 1.65.

c. Garnet sand. A sieve analysis shall be provided. The media shall have an effective size from 0.15 to 0.35 mm.

d. Granular activated carbon (GAC) may be used as a media for filtration. The department may require pilot studies where precursor or organics removal is a treatment objective. The design shall include the following:

(1) GAC media shall meet the basic specifications for filter media contained in this section, except the uniformity coefficient shall not be greater than 2.0. The department may allow larger size media based upon pilot-scale or full-scale demonstration testing. The department may require that a layer of sand media be placed below the GAC.

(2) Provisions shall be made for periodic treatment of GAC filter material for the control of bacteria and other growths.

(3) Provisions shall be made for GAC media replacement or regeneration.

(4) Only materials suitable for use with GAC media filters shall be utilized.

F. Support media.

1. Sand. A sieve analysis shall be provided. A three-inch layer of sand shall be used as a supporting media for the filter media where supporting gravel is used and shall have an effective size from 0.8 to 2.0 mm and a uniformity coefficient not greater than 1.7.

2. Gravel. When used as the supporting media, gravel shall consist of hard, rounded particles and shall not include flat or elongated particles. The coarsest gravel shall be 2-1/2 inches in size when the gravel rests directly on the strainer system and shall extend above the top of the perforated laterals or strainer nozzles. Not less than four layers of gravel shall be provided in accordance with the size and depth distribution specified in Table 874.1.

3. Changes of gravel depths and sizes may be considered by the department where proprietary filter bottoms are proposed.

| TABLE 874.1 Gravity Filter Gravel Support Bed | | | --- | --- | | SIZE | DEPTH | | 2-1/2 - 1-1/2 inches | 5 - 8 inches | | 1-1/2 - 3/4 inches | 3 - 5 inches | | 3/4 - 1/2 inches | 3 - 5 inches | | 1/2 - 3/16 inches | 2 - 3 inches | | 3/16 - 3/32 inches | 2 - 3 inches |

G. Filter bottoms and strainer systems. The department may allow deviations from requirements of this subdivision for high rate filters and for proprietary filter bottoms. Porous plate bottoms shall not be used where iron, manganese, or hard water may result in clogging. The design of manifold-type collection systems shall:

1. Minimize loss of head in the manifold and laterals;

2. Assure even distribution of backwash water and an even rate of filtration over the entire area of the filter;

3. Provide a ratio of the area of the final openings of the strainer systems to the area of the filter of about 0.003;

4. Provide a total cross-sectional area of the laterals at about twice the total area at the final openings; and

5. Provide a manifold that has a cross-sectional area which is 1-1/2 to two times the total area of the laterals.

H. Surface wash or air scouring of filters shall be provided.

1. All rotary surface wash devices shall be designed with:

a. Provisions for water pressures of at least 45 psig;

b. A vacuum breaker or other device or assembly to prevent backsiphonage; and

c. Adequate surface wash water to provide 0.5 - 1.0 gpm/ft² of filter area.

2. Air scouring shall provide for:

a. An air flow rate of three to five scfm/ft² of filter area when air is introduced in the underdrain. A lower air flow rate shall be used when the air scour distribution system is placed above the underdrain.

b. A method for avoiding loss of filter media during backwashing.

c. A fluidization backwash following air scour sufficient to restratify the filter media. The backwash water delivery system shall be in accordance with this section except the rate of flow should not exceed 8.0 gpm/ft² unless operating experience demonstrates that a higher rate is necessary to remove scoured particles from the filter media.

I. Turbidity monitoring.

1. Indicating and recording turbidimeters meeting the requirements of 12VAC5-590-770 B shall be provided for:

a. The source water;

b. The settled water from each sedimentation basin;

c. The filter effluent from each filter; and

d. The CFE.

2. Finished water indicating and recording turbidimeters shall be considered if chemical pH adjustment occurs following filtration.

3. The location of the turbidity sample tap shall allow turbidity to be monitored for both the filtered water and the filter-to-waste water.

4. The design may incorporate an operator selected filter effluent high turbidity alarm.

J. Appurtenances.

1. A sampling tap shall be placed between each filter and the effluent rate-of-flow controller to sample filtered water and filter-to-waste water. The location of sample taps shall allow turbidity to be monitored of both the filtered water and the filter-to-waste water.

2. Indicating and recording loss-of-head gauges shall be provided on all filters having a capacity of greater than 100 gpm. An indicating loss-of-head gauge shall be provided on all filters having a capacity of 100 gpm or less.

3. Indicating and recording rate-of-flow gauges shall be provided on all filters having a capacity of greater than 100 gpm. An indicating and totalizing water meter may be used instead of an indicating and recording gauge on filters having a capacity of 100 gpm or less.

4. Effluent rate-of-flow controllers of the direct acting, indirect acting, or constant rate types shall be provided on each filter.

a. All control devices used shall incorporate an auxiliary shutoff valve in the filter effluent line. Indirect and direct acting effluent rate-of-flow control devices shall start operation from the closed position. Failure of indirect acting controllers shall not result in any increase in the rate of flow.

b. Filter effluent rate-of-flow control that simply maintains a constant water level on the filter is prohibited.

c. Control devices shall be configured to prevent exceeding the design filter hydraulic loading rate when any filter is taken out of service.

5. Provisions for draining the filter-to-waste (rewash) with appropriate backflow prevention and rate control shall be provided on each filter. The filter-to-waste design flow rate shall be equal to the filtration rate.

6. A high pressure hose and hose rack shall be provided to allow washing down filter walls.

K. Backwash provisions.

1. Filtered or finished water shall be applied uniformly across the filter in an upflow direction to provide at least 50% media expansion during all operating conditions. This will normally require backwash flow rates of up to 20 gpm/ft²depending on media size, media specific gravity, uniformity coefficient, and water temperature.

2. The backwash water shall be provided at the required rate by backwash pumps, backwash water tanks, the high service main, or a combination of these methods. Consideration should be given to including provisions to obtain backwash water from the distribution system or other sources and to supply backwash water during plant start-up or during catastrophic events.

3. At least two backwash water pumps shall be installed unless an alternate means of obtaining backwash water is available.

4. The volume of backwash water provided shall be sufficient to backwash one filter at the design backwash flow rate and duration during the warmest water temperature. This backwash water volume shall be in addition to any other water storage requirements.

5. A backwash water controller or valve shall be provided on the main backwash water supply line to obtain the desired rate of filter wash with the backwash water valves on the individual filters open wide.

6. Consideration shall be given to provide for seasonal adjustments of the backwash flow rate to ensure proper backwashing while preventing media loss and to conserve water.

7. The rate-of-flow indicator on the main backwash water supply line shall be located so that it may easily be read by the operator during the backwashing process.

8. Where backwash water pumps are provided, a means for air release shall be installed between the backwash water pump and the backwash water valve.

L. Other design considerations.

1. Roof drains shall not discharge into the filter or basins and conduits preceding the filters.

2. Provision shall be made for continuous operation of all other filtering units while one filtering unit is out of operation.

3. High rate filtration shall be provided with precise coagulation control. A multiple six-gang stirring machine for performing jar tests shall be provided in addition to one or more of the following means of controlling the coagulation process:

a. Zeta potential, as measured by microelectrophoresis.

b. Pilot filters. Where dual pilot filters are used, two units shall be provided. Each pilot filter shall consist of a small filter (about six inches in diameter) containing the same type and depth of media as the plant filters. The pilot filter shall be equipped with recording turbidimeters on the effluent to measure the filterability of the water as reflected by turbidity monitoring.

c. Streaming current monitor, defined as a continuous sampling instrument that measures the electric current generated when water flows past suspended particles contained in the water.

4. High rate filtration shall be provided with indicating and recording pH monitoring equipment for:

a. The source water;

b. The rapid mix effluent; and

c. The finished water leaving the treatment plant.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-875 Direct filtration

A. Direct filtration is defined as a series of treatment processes, including coagulation and filtration but excluding sedimentation. Direct filtration shall be considered only for treatment of high quality and seasonally consistent surface water sources or GUDI sources.

B. An in-plant demonstration study or pilot study shall be required to demonstrate acceptable performance of direct filtration. The study shall be conducted over a sufficient time to treat all expected source water conditions throughout the year. The pilot plant filter shall be of a similar type and operated in the same manner as proposed for full-scale operation.

C. The department may require presedimentation meeting the requirements of 12VAC5-590-865 C to be provided (in the treatment sequence) to direct filtration treatment plants.

D. Rapid mix coagulation and flocculation shall be provided, meeting the requirements of 12VAC5-590-871.

E. Filters shall be dual media or multimedia gravity filters. Design of filtration units shall meet requirements for rapid rate or high rate gravity filters in 12VAC5-590-874, including filter structure, filter media, support gravel, backwash provisions, rate-of-flow control, surface wash, or air scour. Alternative designs may be considered by the department.

F. Turbidity monitoring.

1. Indicating and recording turbidimeters meeting the requirements of 12VAC5-590-770 B shall be provided for:

a. The source water;

b. The filter effluent from each filter; and

c. The CFE.

2. Finished water indicating and recording turbidimeters shall be considered if chemical softening occurs following filtration.

G. Where automatic unit process control is provided, manual override of all automatic features shall be provided.

1. Automatic start-up of treatment plant unit processes is prohibited.

2. Valve actuators shall be provided with manual override capability.

H. The plant design should allow for the future installation of sedimentation basins.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-880 Diatomaceous earth filtration

| | | | | --- | --- | --- | | | | | | | | | | | | | | | | | | | | |

A. Diatomaceous earth filtration shall be limited to treatment of a surface water source, a GUDI source, or both with low turbidity and low bacterial contamination, and may be used for iron removal from groundwater.

B. Pilot plant study. Installation of a diatomaceous earth filtration system shall be preceded by a pilot plant study on the water to be treated.

C. Types of filters. Pressure or vacuum diatomaceous earth filtration units will be considered for approval.

D. Treated water storage. Treated water storage capacity in excess of normal requirements shall be provided to:

1. Allow operation of the filters at a uniform rate during all conditions of system demand at or below the approved filtration rate, and

2. Guarantee continuity of service during adverse source water conditions without bypassing the system.

E. Number of units. At least two filtering units shall be provided at plants having a rated capacity of more than 100 gpm.

F. Precoat.

1. Application. A uniform precoat shall be applied hydraulically to each septum by introducing a slurry to the tank influent line and employing a filter-to-waste or recirculation system.

2. Quantity. Diatomaceous earth in the amount of 0.2 lb/ft² of filter area.

G. Body feed. A body feed system to apply additional amounts of diatomaceous earth slurry during the filter run is required.

1. Quantity. Rate of body feed is dependent on source water quality and characteristics and must be determined in the pilot plant study.

2. Adequate accessibility to the feed system and slurry lines is required.

3. Continuous mixing of the body feed slurry is required.

4. Consideration should be given to providing a coagulant coating (alum or suitable polymer) of the body feed.

H. Rate of filtration. The hydraulic loading rate shall not exceed 1.5 gpm/ft² of filter area. The filtration rate shall be controlled.

I. Head loss. The head loss shall not exceed 30 psi for pressure diatomaceous earth filters, or a vacuum of 15 inches of mercury for a vacuum system.

J. Recirculation. A recirculation or holding pump shall be employed to maintain a differential pressure across the filter when the unit is not in operation to prevent the filter cake from dropping off the filter elements. A minimum recirculation rate of 0.1 gpm/ft§ filter area shall be provided.

K. Septum or filter element. The filter elements shall be structurally capable of withstanding maximum pressure and velocity variations during filtration and backwash cycles, and shall be spaced so that no less than one inch is provided between elements or between any element and a wall. Means shall be provided to check the septum for cleanliness or damage. Consideration should be given to providing septum assemblies where an individual septum can be removed, cleaned, repaired, and replaced.

L. Inlet design. The filter influent shall be designed to prevent scour of the diatomaceous earth from the filter element.

M. Backwash. Provision shall be made for periodic backwashing of the filter. A satisfactory method to thoroughly remove and dispose of spent filter cake shall be provided.

N. Appurtenances. The following shall be provided for every filter:

1. Sampling taps for source and filtered water;

2. A loss-of-head or a differential pressure gauge;

3. A rate-of-flow indicator, preferable with totalizer; and

4. A throttling valve used to reduce rates below normal during adverse source water conditions.

O. Turbidity monitoring. Indicating and recording turbidimeters meeting requirements of 12VAC5-590-770 B shall be provided for:

1. The source water;

2. The effluent from each filter unit; and

3. The CFE.

P. An operation and maintenance manual shall be provided for all diatomaceous earth filtration units. The manual shall include the following:

1. A detailed description of the treatment units and the control of each unit for optimal performance;

2. A preventative maintenance schedule;

3. The manual adjustment and override procedures for all automatic control features; and

4. A troubleshooting guide for typical problems.

Q. The owner shall require the equipment manufacturer to provide onsite start-up and follow-up training.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-009.04 § 3.25, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-881 Slow sand filtration

A. Slow sand filters shall be approved only after a pilot study demonstrates that the water supply contains sufficient nutrients for use of this treatment technology.

B. At least two filters shall be provided. In all cases, the filters shall be capable of meeting the design maximum daily water demand with one filter out of service.

C. Sand shall be clean silica sand that meets the following criteria:

1. The effective size shall be between 0.15 mm and 0.35 mm;

2. The uniformity coefficient shall not exceed 2.5; and

3. The sand depth shall not exceed 55 inches. A minimum depth of 30 inches is required for normal operation.

D. Supporting media gravel shall meet the requirements of 12VAC5-590-874 F.

E. Structural details.

1. All slow sand filters shall be covered.

2. Sufficient head room shall be provided for normal movement on the filter by operating personnel for periodic sand removal operations.

3. Adequate manholes and access ports shall be provided for moving sand off and onto the filter.

4. There shall be no common wall between the finished water and any water of lesser quality.

5. All filters shall be protected from freezing.

F. General design requirements.

1. Filter to waste shall be provided for all slow sand filters.

2. Water entering the filter shall be distributed in a manner so that the surface of the filter shall not be disturbed in any way.

3. The nominal rate of filtration range shall be from 45 to 150 gpd/ft² (0.031 to 0.10 gpm/ft²) of sand area.

4. The minimum depth of water over the filters shall be three feet. The maximum depth of water over the filters shall not exceed five feet. An overflow capable of handling the maximum flow to the filter shall be provided at the maximum filter water level.

5. Underdrains shall be provided to assure an even rate of filtration across the filter surface. The maximum velocity of water in the lateral underdrains shall be 0.75 ft/sec. The underdrain spacing shall not exceed three feet.

6. Each filter shall be capable of being filled with water from the bottom up.

7. Each filter shall be equipped with a loss-of-head gauge; a rate-of-flow control device such as an orifice, weir, or butterfly valve; a weir or effluent pipe designed to assure that the water level over the filter never drops below the sand surface; and filtered water sample taps.

8. Monitoring, indicating, and recording turbidimeters meeting the requirements of 12VAC5-590-770 B shall be provided for:

a. The source water;

b. The filter effluent from each filter unit; and

c. The CFE.

9. The filters shall be designed to operate to waste after scraping or replacement of the sand, until the ripening process is complete and the turbidity meets the requirements of 12VAC5-590-395 A 2 b (3).

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-882 Membrane filtration

A. Applicability. This section pertains to the use of membrane filtration as follows:

1. For pathogen and turbidity log removal credits in accordance with Table 500.1 in 12VAC5-590-500, the use of MF and UF are allowed.

2. For softening, total dissolved solids (TDS) removal, organics removal, and other treatment purposes, reverse osmosis (RO) and nanofiltration (NF) are allowed in accordance with 12VAC5-590-680 G.

B. Membrane filtration systems shall meet all requirements contained in 12VAC5-590-401 E 6 b to be granted removal credit for Giardia lamblia and Cryptosporidium.

C. A demonstration study shall be conducted on the water to be treated before the installation of a membrane filtration system unless the owner can demonstrate to the satisfaction of the department that the source water quality range over all four seasons of a year will be adequately treated by the proposed design.

D. All membrane treatment units for pathogen and turbidity removal shall employ MF or UF using hollow fiber, positive pressure-driven membrane filtration technology. They may employ either an inside-to-outside or outside-to-inside flow direction.

E. The number of membrane units shall be a function of the overall treatment facility capacity, waterworks capacity, and water demand. Multiple membrane units shall be provided where the treatment facility design capacity exceeds 0.5 MGD.

F. Approved materials and chemicals.

1. All membrane materials, associated piping, and other components in contact with the water shall be in accordance with 12VAC5-590-810.

2. Chemicals used in any membrane cleaning process shall be in accordance with 12VAC5-590-515.

G. Turbidity monitoring. Continuous indicating and recording equipment meeting the requirements of 12VAC5-590-770 B shall be provided for the following locations:

1. Source water;

2. Pretreated water, such as by coagulation, flocculation, and sedimentation (if applicable);

3. Filtrate from each membrane unit; and

4. Combined filter effluent, where more than one membrane unit is installed.

H. Indicating and recording equipment for entry point chlorine residual monitoring shall be provided. Indicating and recording equipment for filtered water temperature monitoring shall be provided.

I. Pressure monitoring:

1. Indicating equipment shall be provided for monitoring the pressure drop across any prefilter.

2. Indicating and recording equipment shall be provided for monitoring the pressure drop across membrane modules, (i.e., transmembrane pressure).

3. Integrity monitoring. Indicating and recording equipment for direct integrity test monitoring shall be provided and shall document the date, time, and results of every test performed on each unit.

J. Flow measurement. Equipment shall be provided for measuring or calculating the following flows:

1. Source water, gpm and totalized;

2. Filtrate from each unit, gpm and totalized;

3. Flux from each unit, gpd/sf;

4. Recirculation to each unit, gpd or percent of feed flow, if applicable;

5. Entry point, gpm and totalized; and

6. Waste.

K. An alarm system shall be provided that will report alarm conditions and shut down the treatment plant and entry point flow as necessary.

1. All alarms shall be reported to a location manned 24 hours per day or to a person on call and shall report alarm conditions audio-visually at the water treatment plant.

2. At a minimum, the following points shall be monitored by the alarm system. Alarm and shut down set point conditions will be determined by the department on an individual basis.

a. Feed water flow;

b. Feed water turbidity, if required by the department;

c. Filtrate turbidity from each unit exceeding operational control criteria;

d. Membrane direct integrity test initiation, failure, and exceeding operational control criteria; and

e. Entry point disinfectant residual.

L. Sample taps shall be provided to monitor the following:

1. Source water;

2. Source water storage tank effluent;

3. Feed water after prefiltration;

4. Filtrate from each membrane unit;

5. Combined filtrate from all units;

6. Entry point; and

7. Additional sample taps to monitor the presence of cleaning solutions used in either the backwash or cleaning operations.

M. Equipment shall be provided, using variable frequency drive or other suitable means to adjust the feed pump output in order not to exceed the design flux in the event modules are taken off line.

N. Pressure gauges.

1. A portable, pocket-type pressure gauge of the correct range and accuracy for the application and with the capability of being calibrated shall be provided to check the pressure readings of the pressure transducers installed on the membrane units.

2. At each location of a pressure transducer, a 1/4-inch diameter pressure gauge with American National Standard Taper Threads ( NPT) connection shall be provided to facilitate the connection of a portable, pocket-type test gauge.

O. Clean-in-place systems, including tanks, piping, all joints, and valves, shall be compatible with the cleaning solution and shall be corrosion resistant.

P. An operation and maintenance manual shall be provided for all membrane filtration treatment units. The operation and maintenance manual shall include the following:

1. A maintenance schedule for each piece of equipment.

2. Operation procedures, including software user instructions.

3. A troubleshooting guide.

4. Identification of specific proprietary equipment or software not available to the owner or operator.

5. A service call number.

6. DIT requirements.

7. Chemical cleaning instructions.

8. A detailed description of the treatment units and the control of each unit for optimal performance.

Q. A means shall be provided to isolate a compromised module or fiber or both. A means to visually inspect modules while simultaneously conducting the DIT shall be provided. Alternatively, sonic testing equipment that provides a relative accelerometer reading shall be provided where visual inspection cannot be performed.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-883 Bag and cartridge filtration

A. Bag or cartridge filtration shall be limited to treating a surface water source, a GUDI source, or both with low turbidity.

B. A pilot plant study shall be conducted on the water to be treated before the installation of a bag or cartridge filter system.

C. Bag and cartridge filtration systems shall be granted removal credit for Giardia lamblia and Cryptosporidium in accordance with 12VAC5-590-401 E 6 a, provided that they meet the requirements of this section.

D. General design requirements.

1. All system components such as housing, bags, cartridges, gaskets, O-rings, and other components in contact with water shall be in accordance with 12VAC5-590-810. All cartridge filter housing shall be certified by the ASME certification program, or equivalent, for pressure vessels and stamped with the appropriate certification mark.

2. Indicating and recording turbidimeters meeting requirements of 12VAC5-590-770B shall be provided for the source water and the CFE. The department may require indicating and recording effluent turbidimeters for each filter unit.

3. The maximum flux rate across the final filter shall not exceed 0.2 gpm/ft².

4. Maximum differential pressure across the cartridge filter shall not exceed 20 psi.

5. Pressure gauges and sampling taps shall be provided before and after each bag or cartridge filter.

6. Provisions to accomplish filter-to-waste shall be provided.

7. Automatic start-up of bag or cartridge filters is prohibited.

8. An alarm system shall be provided that will report alarm conditions and shut down the treatment plant and entry point flow.

a. All alarms shall be reported to a location manned 24 hours per day or to a person on call and shall report alarm conditions audio-visually at the water treatment plant.

b. The following shall be monitored by the alarm system:

(1) Source water turbidity;

(2) Feed water flow;

(3) If applicable, filtrate turbidity from each unit exceeding operational control criteria;

(4) Combined filter effluent turbidity exceeding operational control criteria;

(5) Differential pressure at each unit; and

(6) Entry point disinfectant residual.

9. At least two filtering units shall be provided at plants having a rated capacity of greater than 100 gpm.

E. Operation and maintenance documents shall be provided for all bag or cartridge filter units and shall include:

1. Detailed description of the bag or cartridge treatment units and the control of each unit for optimal performance.

2. Procedural criteria, such as pressure differential, turbidity, and other parameters, and expected frequency of bag or cartridge filter replacement.

3. A preventative maintenance schedule.

4. Manual adjustment and override procedures for any automatic control features.

5. Troubleshooting guide for typical problems.

F. The owner shall require the equipment manufacturer to provide onsite start-up and follow-up training.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-890 (Repealed.)

History

• Historical Notes: Derived from VR355-18-009.05 § 3.26, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-895 Pre-engineered package treatment units

A. Pre-engineered package treatment units are defined as predesigned, factory built, and transported virtually assembled to the operation site. The provisions of 12VAC5-590-290 shall apply.

B. General design considerations.

1. A rapid mix unit process shall be provided. The design shall meet requirements of 12VAC5-590-871 A.

2. Flocculation units shall meet requirements of 12VAC5-590-871 B or as identified and justified in the approved PER.

3. Sedimentation units shall meet requirements of 12VAC5-590-872 or as identified and justified in the approved PER.

4. Filters shall be dual media or multimedia gravity filters. Design of filtration units shall meet the requirements of 12VAC5-590-874 or as identified and justified in the approved PER.

5. Indicating and recording turbidimeters meeting requirements of 12VAC5-590-770 B shall be provided for the:

a. Source water;

b. Applied water to each filter;

c. Filter effluent from each filter; and

d. CFE.

6. Sufficient overflows and drains shall be provided to maintain a maximum water level within the plant, including the depth of water over the filters, and to facilitate complete draining of the package unit.

7. Where automatic unit process control is provided, operator adjustment of chemical feed rates, times, and sequences shall be provided as well as a manual override of all automatic features.

a. Automatic start-up of water treatment unit processes is prohibited.

b. Valve actuators shall be provided with manual override capability.

8. Treatment units installed at ground level shall be provided with stairways, walkways, or other suitable means to allow access for operation and maintenance and observation of all treatment process units. Filters shall be adequately accessible to facilitate evaluation of the entire filter bed for media condition and placement, fluidization during backwashing, and evaluation of compaction during filtration.

C. An operation and maintenance manual shall be provided for all pre-engineered package treatment units. The operation and maintenance manual shall include the following:

1. A detailed description of the treatment units and the control of each unit for optimal performance.

2. A preventative maintenance schedule.

3. Manual adjustment and override procedures for any automatic control features.

4. A troubleshooting guide for typical problems.

D. The owner shall require the equipment manufacturer to provide onsite start-up and follow-up training.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-900 Cation exchange softening

A. The softening design selected shall be based upon the mineral qualities of the source water and the desired finished water quality in conjunction with requirements for disposal of sludge or brine water, cost of the plant, cost of the chemicals, and the plant location.

B. Iron, manganese, or a combination of the two, in the oxidized state or unoxidized state, shall not exceed 0.3 mg/L in the water applied to the cation exchange material.

C. The units shall be of pressure or gravity type of either an upflow or downflow design, using automatic or manual regeneration.

D. The design capacity for hardness removal shall not exceed 20,000 grains/ft³when the resin is regenerated with 0.3 pounds of salt per kilograin of hardness removed.

E. The depth of the cation exchange material shall not be less than three feet.

F. The hydraulic loading rate should not exceed seven gpm/ft² and the backwash rate should be six to eight gpm/ft.²

G. The freeboard shall depend upon the specific gravity of the media and the direction of the water flow.

H. The bottoms, strainer systems, and support for the cation exchange material shall conform to criteria provided for rapid rate gravity filters. See also 12VAC5-590-874.

I. Facilities shall be included for even distribution of brine over the entire surface of both upflow and downflow units. Backwash, rinse, and air relief discharge pipes shall be installed in a manner as to prevent any possibility of backsiphonage.

J. A bypass shall be provided around the cation exchange units to produce a blended water of desirable hardness. Meters shall be installed to measure total water delivered to the distribution system and on each softener unit. An automatic proportioning or regulating device and shutoff valve should be provided on the bypass line. In some installations, it may be necessary to treat the bypassed water to obtain acceptable levels of iron and manganese in the finished water.

K. Waters having turbidity of five NTUs or more shall not be applied directly to the cation exchange softener. Silica gel materials should be used for water having a pH above 8.4 and should not be used when iron is present. When the applied water contains a chlorine residual, the cation exchange material shall be a type that is not damaged by the chlorine residual. Phenolic resin shall not be used.

L. Sampling taps shall be provided for the collection of representative samples for both bacteriological and chemical analyses. The taps shall be located to provide for sampling of the softener influent, softener effluent, and the blended water. The sampling taps for the blended water shall be at least 20 feet downstream from the point of blending.

M. Brine measuring or salt-dissolving tanks and wet salt storage facilities shall be covered. The makeup water inlet shall have a free fall discharge of two pipe diameters but not less than two inches above the maximum liquid level of the unit or be protected from backsiphonage. Water for filling the tank should be distributed over the entire surface by pipes above the maximum brine level in the tank. The salt shall be supported on graduated layers of gravel under which is a suitable means of collecting the brine. Wet salt storage basins must be equipped with manhole or hatchway openings having raised curbs and watertight covers with overhanging edges similar to those required for finished water reservoirs. Overflows, where provided, shall be turned down, have a proper free fall discharge and be protected with noncorrodible screens or self-closing flap valves.

N. Wet salt storage basins shall have sufficient capacity to store at least a 30-day operating supply.

O. Stabilization of the finished water for corrosion control shall be considered.

P. Suitable disposal must be provided for the brine waste.

Q. Pipes and contact materials shall be resistant to the aggressiveness of the salt.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-009.06 § 3.27, eff. August 1, 1991; amended, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-910 Aeration

A. Aeration treatment is acceptable for oxidation, separation of gases, or for taste and odor control. General design requirements include the following:

1. The aerated water shall be chlorinated following aeration.

2. The equipment shall incorporate materials resistant to deterioration and corrosion and shall be designed to eliminate the potential for fouling problems from calcium carbonate and iron precipitation and from algae, slime, and bacteriological growth. Disinfection capability shall be provided before the aeration treatment units.

3. The equipment shall be easily accessed and serviced.

4. The air introduced into the treatment units shall be filtered and shall be free of insects, obnoxious fumes, dust, dirt, and other contaminants. If blowers are located inside a building, then the air intakes shall extend to the outside and be furnished with appropriate air filters.

5. Air exhaust outlets shall be located to avoid induced contaminants, particularly at or near occupied areas or blower intakes.

6. Duplicate blowers, motors, or multiple treatment units shall be required for treatment processes designed to meet the drinking water quality standards in 12VAC5-590-340.

B. Natural, forced, or induced draft aeration units shall be designed to provide an adequate liquid distribution and countercurrent of air through the enclosed aeration column, and adequately seal the water outlet to prevent unwanted loss of air.

C. Pressure aeration means the injection of compressed air into the water to be treated, typically for oxidation. Pressure aeration shall not be approved for removal of dissolved gases. Filters following pressure aeration shall have adequate exhaust devices for the release of air. Pressure aeration devices shall be designed to provide thorough mixing of compressed air with the water being treated.

D. Packed tower aeration (air stripping) is suitable for removing VOCs, THMs, carbon dioxide, and radon.

1. Justification shall be provided for the selected design parameters (e.g., height and diameter of the unit, air-to-water ratio, packing depth, surface loading rate, and other features). The design shall consider the effects of temperature change and the resulting impact in contaminant removal efficiency. Pilot plant studies may be required to substantiate the design.

2. The packing material used shall be resistant to the aggressiveness of the water, dissolved gases, and cleaning materials, and shall meet requirements of 12VAC5-590-810.

3. Water shall be evenly distributed at the top of the tower using spray nozzles or orifice-type distributor trays that will prevent short circuiting. A mist eliminator above the water distribution system may be required.

4. A means to allow for discharge and wasting of water or chemicals used to clean the tower shall be provided.

5. Sample taps shall be provided in the influent and effluent piping.

6. The design shall prevent freezing of the influent riser and effluent piping.

7. An overflow pipe discharging 12 to 24 inches above the ground and over a drainage inlet structure or splash pad shall be provided.

8. A sufficient number of access ports with a minimum diameter of 24 inches shall be provided to facilitate inspection, media replacement, media cleaning, and maintenance of the unit interior.

9. A positive air flow sensing device and a pressure gauge shall be installed on the air influent line. If the aeration unit is designed to remove a contaminant with a PMCL, then the positive air flow sensing device shall be an integral part of an automatic control system that will turn off the influent water if positive air flow is not detected.

E. Other methods of aeration shall be designed to meet the particular needs of the water to be treated and are subject to the approval of the department.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-009.07 § 3.28, eff. August 1, 1991; amended, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-920 Iron and manganese control

A. Iron and manganese control, as used in this section, refers solely to treatment processes designed specifically for this purpose. The treatment process used will depend upon the character of the source water. The selection of one or more treatment processes shall meet specific local conditions as determined by engineering investigations, including chemical analyses of representative samples of water to be treated, and receive the approval of the department. The department may require that pilot studies be conducted.

B. Iron and manganese removal by oxidation and filtration.

1. Oxidation shall be accomplished by aeration or by chemicals, such as chlorine, potassium permanganate, sodium permanganate, or a combination thereof.

2. The design shall consider:

a. pH adjustment to promote rapid oxidation;

b. A pre-settling tank located ahead of the filters to remove oxidized iron and increase filter run times;

c. A manganese-oxide coating on the filter media, such as manganese greensand. The total depth of media shall not be less than 30 inches. Media shall have an effective size from 0.3 to 0.35 mm and a uniformity coefficient of no more than 1.6. Following initial placement of the media, care shall be taken to remove fines by backwashing and skimming the surface; and

d. An anthracite cap layer over the manganese-oxide coated media having a depth of six to 18 inches.

3. Aeration shall be designed in accordance with 12VAC5-590-910.

4. Flow proportional chemical feeders shall be provided, and the feed rate shall be adequately controlled by using feeders that are paced by water meters to prevent an over-dosage of chemical. A flow switch in place of a flow proportional feeder may be permissible.

5. Sample taps shall be provided before the application of the oxidant, immediately ahead of filtration, and at the filter effluent.

6. Pressure filters shall include provisions for:

a. Pressure gauges on the inlet and outlet pipes of each filter or a differential pressure gauge on each filter;

b. An easily readable meter or flow indicator on each battery of filters. A flow indicator is recommended for each filtering unit;

c. Filtration, backwashing, and filter-to-waste of each filter individually:

(1) Backwash water shall be evenly distributed in an adequate quantity to achieve at least a 30% media bed expansion during backwashing. The backwash rate shall be based on the media;

(2) The top of the backwash water collection trough shall be at least 18 inches above the media surface;

(3) An underdrain system to efficiently collect the filtered water and to distribute an adequate quantity of backwash water to achieve at least a 30% media bed expansion during backwashing;

d. Flow indicators and controls are located so that they are easily readable while operating the control valves;

e. An air release valve on the highest point of each filter;

f. An accessible manhole to facilitate inspections and repairs for filters greater than 36 inches in diameter;

g. A means to observe the wastewater during backwashing; and

h. Construction to prevent cross-connection.

C. Iron and manganese removal by ion exchange shall only be approved for removing low concentrations (less than 0.5 mg/L) of combined iron and manganese. The department may require pilot studies be conducted to determine post-exchange pH/alkalinity adjustment. See 12VAC5-590-900 for general ion exchange design requirements.

D. Sequestering iron and manganese.

1. Sequestration with polyphosphates shall be considered for polishing filtered water; however, it shall not be used where the residual iron, manganese, or combination thereof exceeds 1.0 mg/L.

2. Phosphate feed rates shall be determined by the product manufacturer and shall not exceed 10 mg/L.

3. Feed equipment shall be in accordance with the requirements of 12VAC5-590-860.

4. Stock phosphate solution shall be disinfected in accordance with manufacturer recommendations unless the phosphate solution is fed directly from the covered shipping container.

5. Sodium silicate or other silicate-based chemicals for the sequestration of iron and manganese shall be approved by the department on an individual basis. Operational data from actual full-scale facilities treating waters of similar quality or pilot tests may be required.

E. Sampling taps shall be provided for control purposes. Taps shall be located on each source water, each treatment unit influent, and each treatment unit effluent.

F. Iron and manganese testing equipment shall be provided. Iron testing equipment shall be capable of accurately measuring iron concentration as low as 0.1 mg/L. Manganese testing equipment shall be capable of accurately measuring manganese concentration as low as 0.05 mg/L.

G. The department may approve proprietary treatment processes for the removal of iron and manganese on an individual basis. Operational data from actual full-scale facilities treating waters of similar quality or pilot tests may be required. The provisions of 12VAC5-590-290 may apply.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-009.08 § 3.29, eff. August 1, 1991; amended, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-930 Fluoridation

A. The board recommends that all community waterworks in Virginia be optimally fluoridated. Fluoridation feed systems shall be designed to deliver the optimum fluoride ion concentration as determined by the U.S. Department of Health and Human Services.

B. Fluoride compounds. Commercial sodium fluoride, sodium fluorosilicate (also called sodium silicofluoride), and fluorosilicic acid (also called hydrofluorosilicic acid) shall conform to the applicable AWWA standards or NSF/ANSI/CAN Standard 60-2020, as appropriate.

C. Fluoride compound storage. Fluoride chemicals shall be isolated from other chemicals to prevent cross contamination. Compounds shall be stored in covered or unopened shipping containers in a separate room (except sodium fluoride saturators) with the chemical feeder.

D. Chemical feed installations.

1. Scales and loss-of-weight recorders for dry chemical feeders and hydrofluorosilicic acid feeders shall be provided.

2. Fluoride metering pumps shall have an accuracy so that the actual feed rate will be within 5.0% of the intended feed rate.

3. The point of application shall be located to provide adequate mixing.

4. All fluoride feed lines shall be provided with adequate anti-siphon devices.

5. Design of fluoride saturators shall consider:

a. The source water hardness. The water applied to the sodium fluoride saturator feeders shall be softened if the hardness exceeds 50 mg/L.

b. The fluoride source. Use only sodium fluoride in the saturators.

c. A flow restrictor with a maximum flow of 2.0 gpm on all upflow saturators.

6. Adequate fluoride feed rate control and mixing shall be provided.

7. Provisions shall be made for venting fluorosilicic acid carboys to the outside of the building when the carboys are in use.

E. Suitable protective equipment shall be provided which includes gloves, aprons, dust mask, and goggles.

F. Suitable equipment shall be provided for wet mopping and hosing dust that might accumulate in the plant. Dry feeders shall be equipped with bag loading hoppers.

G. Equipment shall be provided for measuring the quantity of fluoride ion in the water. Testing equipment shall be colorimetric or electrode type as approved by the department.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-009.09 § 3.30, eff. August 1, 1991; amended, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-940 Fluoride removal

A. Fluoride removal may be accomplished by blending with a different quality water or by removal treatment. Where fluoride removal is required, the treatment units shall be designed to achieve a finished water fluoride concentration that is below the SMCL.

B. Blending. Blended water shall result in all water delivered to the distribution system being of the same quality.

C. Treatment.

1. Treatment shall include ion exchange, activated alumina, bone char, RO, or electrodialysis. The selected design shall be supported by pilot studies, unless at least two pilot studies or two prototype plants have demonstrated that the selected design is feasible. These studies or prototypes shall be for waters having characteristics similar to the water that is to be treated.

2. Water pH shall be adjustable to an optimum level to achieve the best fluoride removal.

3. With any one unit out of service, the remaining units shall be capable of treating the maximum plant flow rate.

4. Filter clogging constituents such as iron having a concentration greater than 1.0 mg/L shall be removed before fluoride removal.

5. Test equipment shall be provided and must be accurate to at least 0.1 mg/L.

6. An operation and maintenance manual shall be provided.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-009.10 § 3.31, eff. August 1, 1991; amended, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-950 Corrosion control or stabilization

A. Water that is unstable due either to natural causes or to the treatment applied to the water shall be stabilized.

B. Deposition of calcium carbonate film. The desired calcium carbonate film may be obtained by using either soda ash or caustic soda when the alkalinity of the water exceeds about 35 mg/L. Soft waters should be treated with lime to provide the required calcium. Soft waters that also have a low carbon dioxide content may need a mixture of lime and soda ash to provide both calcium and carbonate for the calcium carbonate film.

C. Phosphates or other corrosion inhibitors may be used for corrosion control when applied in accordance with manufacturer recommendations and when they meet the requirements of 12VAC5-590-515. Stock phosphate solution shall be disinfected in accordance with manufacturer recommendations unless the phosphate solution is fed directly from the covered shipping container.

D. Cathodic protection shall be acceptable for preventing or reducing corrosion of the inner surfaces of water storage tanks and standpipes and the outer surface of metal pipe.

E. Laboratory equipment shall be provided for determining the effectiveness of stabilization treatment and the concentration of chemicals in the treated water.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-009.11 § 3.32, eff. August 1, 1991; amended, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-960 Taste and odor control

A. The continuous or periodic treatment of source waters with copper sulfate and other copper compounds to kill algae or other growths shall be controlled to prevent a copper concentration in excess of 1.0 mg/L, as copper, in the finished water leaving the treatment plant.

B. Surface water aerators or diffused aeration systems shall be acceptable for de-stratifying reservoirs, reducing or eliminating seasonal turnover, and releasing compounds in the anaerobic or anoxic zones.

C. Addition of chemical oxidants at the source water intake, in the source water pump station discharge line, at the head of the treatment plant, or within the treatment train shall be acceptable for treating tastes and odors. Effective oxidants include chlorine, chlorine dioxide, potassium permanganate, and ozone. If breakpoint chlorination is proposed, then the actual breakpoint of the water shall be determined accurately. "Breakpoint chlorination" means the addition of chlorine to water until the chlorine demand has been satisfied, chlorine and ammonia nitrogen reactions are near completion, and further additions of chlorine result in a free chlorine residual that is directly proportional to the amount of chlorine added.

D. Powdered activated carbon (PAC). When taste and odor problems are anticipated on an intermittent basis, the addition of PAC shall be considered, and a pilot study shall be conducted to determine the optimum dosage. Multiple PAC feed locations shall be evaluated to provide maximum contact time, including the rapid mixer, the flocculation basins, and at the midpoint of the sedimentation basins.

1. PAC shall not be applied near the point of chlorine or other oxidant application.

2. Continuous agitation or resuspension equipment shall be required to keep the PAC from depositing in the slurry or storage tank.

3. All mechanisms for handling dry PAC shall be tightly sealed. Dust collection is required at all installations.

4. The PAC feed lines to the application points shall be sized to handle the PAC suspension and should be equipped with flushing provisions.

E. GAC media shall be acceptable in conventional gravity filters or in separate contactors to reduce taste and odor.

F. Ozonation shall be acceptable for taste and odor control.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-009.12 § 3.33, eff. August 1, 1991; amended, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-970 (Repealed.)

History

• Historical Notes: Derived from VR355-18-009.13 § 3.34, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 12, Issue 2, eff. November 15, 1995; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-975 Removal of radionuclides

A. Processes for the removal of radionuclides specified as BAT are identified in 40 CFR 141.66. The specific process and equipment proposed for removal of radionuclides shall to the satisfaction of the department have a demonstrated history of successful performance with similar water quality characteristics and performance requirements. Otherwise, the procedures of 12VAC5-590-290 shall apply.

B. When manganese greensand filter systems are utilized, the design shall meet the requirements of 12VAC5-590-920 B. In addition, a chemical contact tank with a minimum detention time of 30 minutes shall be provided. Laboratory or pilot studies may be required to demonstrate compliance with the radium standard when using a filtering treatment system for groundwater with total radium greater than 10 pCi/L.

C. Waste handling, disposal, and permitting shall be given special consideration early in the design process.

D. Occupational exposure shall be considered in the project design.

E. Provisions for operational control monitoring of the radionuclides requiring removal or of acceptable surrogates shall be included in the project design.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-980 (Repealed.)

History

• Historical Notes: Derived from VR355-18-009.14 § 3.35, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-985 GAC contactors

A. Granular activated carbon (GAC) contactors may be used to adsorb natural organic compounds, taste and odor compounds, and SOCs. The most common applications of GAC contactors in drinking water treatment plants are (i) post-filtration adsorption and (ii) filtration-adsorption, in which some or all of the filter media in a granular media filter is replaced with GAC.

B. General requirements.

1. A demonstration study using bench-scale or pilot-scale tests shall be conducted to determine the GAC media effectiveness, adsorption efficiency, and regeneration frequency.

2. GAC contactors shall be sized for the optimum empty bed contact time.

3. A minimum of two contactor units shall be provided.

4. Bypassing the GAC facility may be permissible under certain circumstances to accommodate seasonal water quality fluctuations and allow for blending water.

C. Hydraulic configuration.

1. Pressure vessel installation may be configured in parallel or in series.

2. For pressure contactors, pre-filter and post-filter pressure gauges shall be installed at each individual contactor unit.

3. The rate of flow through the contactors shall be controlled either manually or automatically to ensure equal flow through each contactor.

D. Design details.

1. For pressure contactors, the maximum pressure loss through the vessels shall be as determined by the product manufacturer.

2. Sample taps, isolation valves, and bypass piping shall be provided before and after each individual contactor unit.

3. Pipes, tanks, and appurtenances shall be corrosion resistant.

4. The GAC facility shall provide the ability to filter-to-waste to prevent carbon fines in the effluent water.

5. Unless otherwise approved by the department, disinfection shall be accomplished following the GAC contactors.

6. If backwashing of GAC specific units is required, then unchlorinated filtered water shall be used.

7. Turbidity monitoring of contactor effluent shall be considered.

8. The facility design shall include provisions for spent carbon disposal, GAC delivery, and storage.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-990 Waterworks waste

A. With the exception of sanitary sewage and flows recycled through the water treatment system, the wastes generated during the operation of water filtration plants constitute industrial wastes and are subject to the State Water Control Law (Chapter 3.1 (§ 62.1-44.2 et seq.) of Title 62.1 of the Code of Virginia).

Industrial wastes generated by water treatment facilities include the following:

1. Filter backwash water;

2. Coagulant residuals;

3. Softening residuals;

4. Iron and manganese residuals;

5. Settled solids from presedimentation units; and

6. Brine wastes.

B. After receipt and review of plans and specifications from the consulting engineer for the water treatment facilities, the department will advise DEQ of any proposal to treat and discharge industrial wastes into state waters. The department will submit a letter or report to DEQ that includes the following:

1. Capacity of the proposed treatment facilities;

2. Location of the proposed facilities;

3. Proposed final disposition of the treated waste effluent;

4. Name and address of the consulting engineer; and

5. Name and address of the owner.

C. Except for recycle flows as described in 12VAC5-590-395 C, the owner will need to satisfy DEQ's requirements for the final disposal of these wastes.

D. The sanitary wastes from water treatment plants must receive treatment. Wastes from these facilities shall be discharged either directly to a sanitary sewer system or to an individual waste disposal facility providing suitable treatment approved by the State Water Control Board.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-009.15 § 3.36, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 19, Issue 20, eff. July 16, 2003; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1000 Disinfection

A. The objective of disinfection is to prevent the occurrence of waterborne diseases from the consumption of drinking water.

B. Primary disinfection shall be provided for all surface water sources, all spring sources, all GUDI sources, and all well sources determined to be of questionable bacteriological quality as required by the department. Consideration shall be given to minimizing the formation of DBPs when designing a disinfection process. Waterworks with groundwater sources requiring disinfection under this section shall meet the requirement of 12VAC5-590-421 A 1 d.

C. All pipes, tanks, and equipment that convey, store, or treat potable water shall be disinfected with chlorine before being placed in service in accordance with the following AWWA standards where applicable: C651-14, C652-19, and C653-20.

D. All residual disinfectant determinations shall be made using methods identified in 12VAC5-590-440.

1. The project documents shall outline the procedures and include the disinfectant dosage, contact time, and method of testing the results of the procedure.

2. Methods of disinfection other than chlorination may be considered by the department on an individual basis.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-009.16 § 3.37, eff. August 1, 1991; amended, Virginia Register Volume 9, Issue 17, eff. June 23, 1993; Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1001 Chlorination

A. General design requirements.

1. Chlorine feed capacity shall be capable of meeting the disinfection requirements under all operating conditions.

a. Chlorine feed systems for primary disinfection at a waterworks using a surface water source, a GUDI source, or both shall provide sufficient capacity to achieve the required microbial log inactivation specified in Table 500.1.

b. Chorine feed systems for primary disinfection at a waterworks using groundwater sources shall provide sufficient capacity to achieve 4-log virus inactivation and removal.

c. Chlorine feed systems for secondary disinfection at a waterworks shall provide sufficient capacity to achieve a minimum chlorine residual at the entry point of 0.2 mg/L for more than 4 hours.

2. Chlorine feed systems for disinfection at a waterworks using a surface water source, a GUDI source, or both shall be sized to deliver the required dose with the largest unit out of operation. Small hypochlorination installations for groundwater source waterworks shall have a spare metering pump, unless it can be demonstrated to the satisfaction of the department that spare equipment is readily available from a local supplier. Spare parts shall be available for all chlorinators to replace parts that are subject to wear and breakage.

3. Consideration shall be given to providing multiple chlorine feed points at all waterworks. For conventional filtration treatment plants, chlorine feed points shall be provided for the source water, applied water to the filters, and filter effluent.

4. The piping providing the water for preparing the chlorine solution shall be designed to prevent contamination of the "bulk treated" finished water.

a. At all facilities treating surface water, pre-filtration and post-filtration disinfection systems shall operate independently of each other to prevent possible siphoning of partially treated water into the clearwell.

b. The water piping to each ejector shall have a separate shutoff valve. A master shutoff valve is prohibited.

5. Provisions shall be made to ensure uniform mixing of the chlorine with the water near the point of application.

6. Residual and contact time.

a. The owner of a waterworks using a surface water source, a GUDI source, or both shall provide a minimum residual (C) and contact time (T) as calculated in accordance with 12VAC5-590-500.

b. The owner of a waterworks using a groundwater source that is required to disinfect shall provide a minimum residual (C) and contact time (T) to achieve 4-log virus inactivation and removal based on maximum design flow rate. Provisions shall be made to prevent short circuiting. The contact basin shall be designed utilizing the appropriate baffle factors referenced in Table 500.15 of 12VAC5-590-500.

7. Automatic proportioning chlorinators shall be provided where the rate of flow is not reasonably constant.

8. Equipment shall be provided for measuring the chlorine residual, employing any method specified in 12VAC5-590-440. The equipment shall be capable of a chlorine residual measurement to the nearest 0.1 mg/L.

9. Continuous chlorine residual analyzers shall be provided at all waterworks that are required to filter and that serve 3,300 or more persons or at any waterworks required by the department. Where a continuous chlorine residual analyzer is provided, the department may require that the design incorporate an operator-selected high or low chlorine residual alarm.

B. Gas chlorine feed systems.

1. Equipment.

a. An ample supply of potable water shall be available for operating the chlorinator. Where a booster pump is required, duplicate equipment shall be provided, and when necessary, standby power shall be provided as well. Equipment for backflow prevention shall be provided. A pressure gauge shall be provided on each chlorinator mixing water piping.

b. Scales for weighing cylinders shall be provided at all waterworks using chlorine gas. At large waterworks, scales of the indicating and recording type shall be considered. Scales shall be recessed unless they are of the low-platform type.

c. Where a manifold of several cylinders is required to evaporate sufficient chlorine, consideration shall be given to the installation of gas evaporators.

d. Automatic switch-over of chlorine cylinders shall be provided to assure continuous disinfection.

2. Chlorine gas leak detection.

a. Automatic chlorine gas leak detection with strategically located sensors and related alarm equipment shall be provided for all installations.

b. A bottle of ammonia hydroxide solution shall be provided for detecting chlorine gas leaks.

3. Emergency cylinder repair kits shall be provided.

4. Consideration shall be given to the provision of caustic soda solution reaction tanks for absorbing the contents of leaking one-ton cylinders where the cylinders are in use.

5. Piping and connections for chlorine gas.

a. Pressure gauges shall be installed on the piping to each chlorinator. Piping systems shall be well supported and adequately sloped to allow drainage. Suitable allowance shall be made for pipe expansion due to changes in temperature.

b. Fittings and appurtenances shall be suitable for handling dry chlorine.

6. Building design.

a. Any building to house chlorine equipment or containers shall be designed and constructed to protect all components of the chlorine system from fire hazards. See 12VAC5-590-720.

b. If gas chlorination equipment and chlorine cylinders are to be in a building used for other purposes, a gas-tight partition shall separate this room from any other portion of the building. Doors to this room shall open only to the outside of the building and shall be equipped with panic hardware. These rooms shall be at ground level and should be separated from the feed area.

c. At least two means of exit shall be considered from each separate room or building in which chlorine is stored, handled, or used. All exit doors shall open outward.

d. A clear glass, gas-tight window shall be installed in an interior wall of the chlorinator room to permit the chlorinators to be viewed without entering the room.

e. Feed lines shall not carry chlorine gas beyond the chlorine feeder room unless the chlorine is under vacuum.

f. Chlorinator rooms shall be provided with a means of heating so that a temperature of at least 60°F can be maintained, but the room should be protected from excess heat. Cylinders shall be kept at essentially room temperature for at least 24 hours before use unless an evaporator is employed.

g. Forced, mechanical ventilation that provides one complete air change per minute shall be installed in all chlorine feed rooms and rooms where chlorine cylinders are stored. The inlet to the air exhaust duct from the room shall be near the floor, and the point of discharge shall be located so as not to contaminate the air inlet to any building or inhabited areas. Air inlets shall be located so as to provide cross ventilation with air and at a temperature that will not adversely affect the chlorination equipment. The vent hose shall run without traps from the chlorinator and shall discharge to the outside atmosphere above grade.

h. The electrical controls for the fans and lights shall automatically operate when the door is opened and can be manually operated from the outside without opening the door.

C. Calcium hypochlorite and sodium hypochlorite feed systems.

1. Both calcium hypochlorite and sodium hypochlorite shall be acceptable for disinfection.

2. Hypochlorite solution feeders of the positive displacement type shall be provided.

3. Adequate mixing of the calcium hypochlorite or sodium hypochlorite solutions shall be provided.

4. Special design considerations for bulk delivery systems:

a. Bulk sodium hypochlorite storage tanks shall be constructed of corrosion-proof materials. Pumps, piping, materials, and appurtenances exposed to the sodium hypochlorite shall be suitable for such use.

b. Sodium hypochlorite storage facilities shall be designed to keep ambient temperature and lighting low. Sodium hypochlorite fumes are corrosive and tanks shall be vented to the outside. Tanks shall be designed for ease of filling, draining, and transfer of contents.

c. Piping, valves, pumps, and pipe accessories shall be designed and configured so as not to allow accumulation of gases that could cause air locking or loss of prime in chemical feed piping or pumps.

d. The design shall provide a system of local or general exhaust features to keep employee exposures below the airborne exposure limits, as described in the Safety Data Sheet for the chemical used, in accordance with federal occupational safety and health standards (29 CFR § 1910.1200 (g)). Local exhaust ventilation is generally preferred because it controls contaminant emissions at the source and thus, preventing dispersion into the general work area which could result in corrosion or exposure. Exhaust equipment and accessories shall be corrosion proof.

e. An eye wash fountain and quick-drench facilities in the immediate work area shall be provided.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1002 Chloramination

A. Chloramines shall be acceptable for secondary disinfection. Chloramines are formed by the reaction of ammonia and chlorine. Multiple chemical species may be created; however, monochloramine is the desired form.

B. The process shall be controlled to minimize formation of dichloramine and nitrogen trichloride, which can create objectionable taste and odors. Control should be sufficient to limit free ammonia leaving the chloramination facility to no more than 0.1 mg/L as nitrogen.

C. pH adjustment facilities shall be provided to maintain pH in the range of 7 to 8.

D. When use of chloramines is proposed, the potential increase of lead leaching within the distribution system shall be considered. Additional distribution system monitoring may be required by the department.

E. The owner shall inform the public before initiating any disinfection process involving chloramines, as directed by the department.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1003 Chlorine dioxide addition

A. Chlorine dioxide may be considered as a pre-oxidant to control tastes and odors, reduce color, oxidize iron and manganese, and reduce DBPPs. Chlorine dioxide may be used for primary disinfection. Where chlorine dioxide is used, consideration shall be given to the formation of the byproducts chlorite and chlorate.

B. Chlorine dioxide is generated onsite from sodium chlorite and either chlorine gas or hypochlorite solution. Chlorine dioxide generation equipment shall be factory assembled, pre-engineered units with a minimum efficiency of 95%. The excess free chlorine shall not exceed 3.0% of the theoretical stoichiometric concentration required.

C. The owner shall inform the public before using chlorine dioxide, as directed by the department.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1004 Ozonation

A. Ozone may be considered as a pre-oxidant to control tastes and odors, reduce color, oxidize iron and manganese, reduce DBPPs, and used for primary disinfection. Where ozone is used, consideration shall be given to the level of bromide and formation of brominated byproducts.

B. Ozone systems are typically comprised of four basic subsystems: ozone generation, feed gas preparation, ozone contactors, and off-gas disposal.

C. The PER shall evaluate water and gas flow rates, oxygen source, generator selection and sizing, contactor design, treatment process location, exhaust gas collection and destruction, and operator requirements.

D. Treatability studies using bench-scale or pilot-scale tests may be required as part of the PER to address the following:

1. Alternate points of ozone application;

2. Ozone demand tests, applied dose, transferred dose, and decay rates; and

3. Ozone byproducts, including bromide and bromate analyses.

E. Ozone systems shall be granted disinfection credit for Giardia lamblia, Cryptosporidium, and viruses, in accordance with 12VAC5-590-401 E 7 and 12VAC5-590-500, provided that they meet the requirements of this section.

1. Ozone residual levels shall be monitored continuously and recorded. For waterworks that claim inactivation credit for ozone, a minimum of two dedicated, online monitors per ozone contactor shall be provided. The location of the monitors shall be acceptable to the department. A portable ozone monitor shall be provided as a backup.

2. Ozone systems using multiple, consecutive contact chambers with gaseous ozone injected in the initial chambers, shall be designed to measure the ozone residual and compute log inactivation of Giardia and virus using the C_effluentT₁₀ Method or the Log Integration CT₁₀ Method, as described in the "Long Term 2 Enhanced Surface Water Treatment Rule Toolbox Guidance Manual," EPA Office of Water (4606), EPA 815-R-09-016, April 2010.

3. Sampling lines shall be designed to minimize the reaction time (typically less than 10 seconds conveyance time).

F. Alarms shall be provided for ozone process control safety. Automatic shutdown features shall be considered.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1005 Ultraviolet light (UV) disinfection

A. All UV reactors shall conform to NSF/ANSI/CAN standards.

B. Each reactor train shall be equipped with an individual flow meter or a single flow meter in conjunction with differential pressure sensors in each treatment train. Reactors shall be sized to treat the design flow.

C. Hydraulic design shall ensure that lamps are submerged and that the entrance of air, negative pressure, or pressure surges in the reactors is prevented. Open channel flow reactors are prohibited.

D. A pressure gauge shall be provided upstream of each reactor. The design shall ensure that the reactor's maximum rated pressure cannot be exceeded.

E. Water quality parameters that may affect UV disinfection system performance shall be evaluated, including calcium, iron, manganese, hardness, and alkalinity. Pretreatment shall be considered for water quality parameters that may result in lamp sleeve fouling.

F. A building to enclose and protect all UV equipment shall be provided. Adequate space between control panels, power supply, and the reactor equipment shall be provided to allow for routine operation and maintenance, including removing lamp and wiper assemblies and for off-line chemical cleaning of reactor lamps.

G. An operation and maintenance manual shall be provided for all UV reactors.

H. UV systems may be used for primary disinfection and shall be granted log inactivation credit for Giardia lamblia, Cryptosporidium, and viruses in accordance with Table 401.7, provided that they meet the requirements of 12VAC5-590-401 E 7 c and this subsection.

1. Only UV reactors that have undergone independent, third-party oversight of the validation testing on a fully assembled system to determine the operating conditions under which the reactors deliver the required UV dose shall be considered for log inactivation credit.

2. The dose-monitoring strategy shall be either the UV intensity set point approach or the calculated dose approach as described in the "Ultraviolet Disinfection Guidance Manual For The Final Long Term 2 Enhanced Surface Water Treatment Rule," Office of Water (4601), EPA 815-R-06-007, November 2006. The dose-monitoring strategy shall be demonstrated through the UV reactor validation testing.

3. At least two reactors shall be provided. Reactors shall be sized to treat the design flow with the largest reactor out of service.

4. Continuous monitoring sensors shall be provided to measure UV intensity. A continuous sensor shall also be provided to measure ultraviolet transmittance (UVT) if the calculated dose approach is utilized.

a. The number of sensors provided shall be the same as that used in validation testing of the reactor.

b. Output from a continuous UVT analyzer shall be capable of being input directly into a control loop for each UV reactor, a SCADA system, or both. A bench-top spectrophotometer may be provided instead of a continuous UVT analyzer.

c. All signals from the sensors shall be displayed for operator response and for recordation.

d. At least one reference sensor for calibration of online UV intensity sensors shall be provided. Reference sensors shall be capable of calibration against a traceable standard.

e. Continuous recording equipment shall be provided with the monitoring sensors to store in memory or print one data point at least every four hours.

5. A means of flow distribution and control among multiple reactors shall be provided. The hydraulic flow profiles and piping configuration shall be identical to or more protective than that tested during equipment validation.

a. For onsite validation, the inlet and outlet piping configuration for the UV facility shall be designed according to manufacturer recommendations and to accommodate any site-specific constraints.

b. To avoid jetting flow and swirling flow, consideration shall be given to exclude expansions for at least 10 pipe diameters upstream of the reactor and to exclude out-of-plane 90-degree bends in series.

c. Each UV reactor shall be capable of being isolated and removed from service. Isolation valves upstream and downstream of each reactor, a drain, and sample taps for each reactor treatment train shall be provided. If the isolation valves are also used for flow control, then the flow control valve shall be located downstream of the UV reactor to limit the disturbance of the flow entering the UV reactor. Bypass piping shall not be allowed.

d. The lateral piping for each UV reactor train shall be sized and configured to provide approximately equal head loss through each UV reactor train over the validated range of flow rates.

6. The control system shall be capable of meeting the monitoring and reporting requirements in 12VAC5-590-401 and 12VAC5-590-570.

7. Automatic shutdown capability under critical alarm conditions shall be provided, including lamp or ballast failure, low liquid level, and high temperature. Alarms shall be provided for low UV validated dose, low UV intensity, low UV transmittance, high flow rate, and mechanical wiper failure.

8. Ground-fault circuit interrupters shall be provided for all lamps. Backup power shall be considered.

9. The owner shall develop a start-up plan and submit the plan to the department for approval. The plan shall include functional testing, determination of validated operating conditions and control settings, performance testing, development of an operation and maintenance manual, and inspection schedules.

I. UV systems not intended for primary disinfection may be used provided that they meet the requirements of this subsection.

1. Continuous sensors to measure UV intensity shall be considered.

2. Each UV reactor shall be capable of being isolated, removed from service, and be provided with bypass piping.

3. Automatic shutdown capabilities shall be provided in the event of lamp or ballast failure.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

Article 4 Pumping Facilities [Repealed]

12VAC5-590-1010 Basic pumping facility design criteria

Pumping facilities shall be designed to maintain the sanitary quality of pumped water. All pumps shall be accessible for servicing and repair.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-010.01 § 3.38, eff. August 1, 1991; amended, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1020 Location

A. The pumping station shall be located to meet the hydraulic needs of the distribution system, preserve the quality of the water pumped, and shall consider the availability of a power or a fuel supply.

B. The station shall be:

1. Elevated to a minimum of one foot above the 100-year flood elevation or protected to that elevation;

2. Accessible at all times unless allowed to be out of service by the department;

3. Graded around the station so as to lead surface drainage away from the station; and

4. Protected to prevent vandalism and entrance by animals or unauthorized persons.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-010.02 § 3.39, eff. August 1, 1991; amended, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1030 (Repealed.)

History

• Historical Notes: Derived from VR355-18-010.03 § 3.40, eff. August 1, 1991; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1040 Pump stations

A. Enclosures.

1. The structure that houses a pump shall be of durable construction, fire and weather resistant, and furnished with lockable, outward opening doors. Underground structures shall be waterproofed.

2. Floors.

a. Pump house floors shall be of good quality concrete with adequate reinforcement and have a minimum thickness of six inches.

b. Pump house floors shall slope at least 1/8 inch per foot toward a screened four-inch-diameter floor drain to the atmosphere or other provisions for gravity drainage.

c. The pump house finished floor elevation should be at least six inches above the finished grade.

3. Openings in floors or roofs or elsewhere for removal of heavy or bulky equipment shall be provided.

a. Craneways, hoist beams, eyebolts, or other adequate facilities for servicing or removal of pumps, motors, or other heavy equipment shall be provided.

b. Adequate means of access shall be provided to lubrication points of equipment if these are located at intermediate points between floors.

4. Heat shall be provided for the safe and efficient operation of the equipment.

5. Adequate ventilation shall be provided for all pumping stations. Forced draft ventilation of at least six changes of air per hour (continuous operation) shall be provided for:

a. All rooms, compartments, pits, and other enclosures below grade; and

b. Any area where an unsafe atmosphere may develop or where excessive heat may build up.

6. In areas where excess moisture could cause hazards to safety or damage to equipment, means for dehumidification shall be provided.

7. Pump stations shall be adequately lighted throughout. All electrical work shall conform to the requirements of the applicable codes.

8. Stair design shall be in accordance with the USBC.

9. Pump stations shall have adequate space for the installation of additional units if needed and for the safe servicing of all equipment.

10. Pump stations shall be designed so that each pump has an individual suction line or the lines shall be so manifolded to ensure similar hydraulic and operational conditions.

B. Suction wells shall:

1. Be watertight;

2. Have floors sloped to allow removal of water and entrained solids;

3. Be covered or otherwise protected against contamination, including contamination by pump lubricants; and

4. Have two pumping compartments or other means to allow the suction well to be taken out of service for inspection, maintenance, or repair.

C. Groundwater well enclosures and aprons.

1. The floor at the well pump house shall meet the requirements of subdivision A 2 of this section.

2. Well pump aprons surrounding the well shall (i) be of quality reinforced concrete, (ii) extend a minimum of three feet in all directions from the well casing, (iii) be at least six inches thick, and (iv) be sloped 1/8 inch per foot away from the well.

3. Well houses or well pump stations in pits are prohibited.

D. Spring enclosures shall be vented by properly hooded and screened pipe extending at least 12 inches above the pump floor or ground surface.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-010.04 § 3.41, eff. August 1, 1991; amended, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1050 Pumps and controls

A. General.

1. Pumps, pump motors, and all accessories shall be controlled in a manner that they will operate at their rated capacity. Where two or more pumps are installed, provision shall be made for proper alternation of the pumps. Alternation may be automatic or manual. Provision shall be made to prevent operation of the pump in the event of a backspin cycle.

2. All pumps shall be driven by motors designed to operate over the full range of operating conditions.

3. All pumps shall be served by control equipment that has overload protection for the air temperature encountered.

4. Electrical controls shall be protected to the 100-year flood elevation and should be located above grade.

5. If standby power is provided by onsite generators or engines, then the provisions for filling the fuel storage tank, the fuel tank itself, and the fuel line shall be designed to protect the waterworks and source water from contamination.

6. Pumps shall be lubricated with water of equal or better quality than the water being pumped or with food grade oil. Water seals shall not be supplied with water of a lesser sanitary quality than that of the water being pumped. Where pumps are sealed with potable water and are pumping water of lesser sanitary quality, the seal shall:

a. Have an air gap of at least two inches or two pipe diameters, whichever is greater, where a break-tank is provided; or

b. Be provided with an approved RPZ assembly.

7. When automatic pre-lubrication of pump bearings is necessary and an auxiliary power supply is provided, the pre-lubrication line shall be provided with a valved bypass around the automatic control.

8. A suitable outlet for drainage from pump glands shall be provided without discharging onto the floor.

B. Booster pumps.

1. Booster pumps, except those connected to supply mains not containing service connections and except those taking suction directly from storage facilities, shall be located or controlled so that:

a. They will not produce negative gauge pressure in their suction line; and

b. The intake pressure shall be at least 20 psi when the pump is in normal operation.

2. An automatic pressure cutoff or a pressure-regulating valve shall be provided to prevent the suction line pressure from dropping to below 10 psi.

3. Automatic or remote control devices shall have sufficient range between the start and cutoff pressure, or another mechanism that will prevent excessive cycling of the pumps.

4. At least two pumping units shall be provided.

a. If only two units are provided, then each shall be capable of delivering the peak hour demand, taking into account storage contributions.

b. If more than two units are installed, then they shall have sufficient capacity so that if any one pump is out of service, the remaining pumps are capable of meeting the peak hour demand, taking into account storage contributions.

c. When using booster pumps to transfer water from atmospheric storage tanks to hydropneumatic tanks located upstream of an entry point into the distribution system, the combined capacity of the two pumps shall equal or exceed the peak hour demand. If fire flow is provided, then a pump separate from the transfer pumps shall be provided to deliver the required fire flow.

d. When booster pumping is required for small noncommunity systems, the reserve capacity requirements may be reduced in accordance with the type and size of system served.

5. Controls shall be provided to shut off pumps in the event that suction conditions may result in cavitation.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-010.05 § 3.42, eff. August 1, 1991; amended, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1060 (Repealed.)

History

• Historical Notes: Derived from VR355-18-010.06 § 3.43, eff. August 1, 1991; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1065 Piping, valves, and meters

A. Piping shall:

1. Be adequately sized to minimize energy losses;

2. Not be subject to contamination;

3. Have watertight joints;

4. Be properly anchored to prevent movement;

5. Be protected against surge or water hammer;

6. Have proper labels to identify the contents of the pipes (12VAC5-590-720 C); and

7. Have all exposed piping, valves, and appurtenances protected against physical damage and freezing.

B. Pumps shall be adequately valved to allow satisfactory operation, maintenance, and repair.

1. If foot valves are necessary, then they shall have a net valve area of at least 2-1/2 times the area of the suction pipe and they shall be screened.

2. Each pump shall have shutoff valves on both suction and discharge sides of the pump.

3. Each pump shall have a positive-acting check valve on the discharge side between the pump and shutoff valve or suitable control features to prevent flow reversal.

4. Surge relief valves or slow-acting check valves shall be designed to minimize hydraulic transients.

5. Discharge control valves and appurtenances shall be located above the pump floor when an above-ground discharge is provided.

6. Pumps shall be equipped with an air release or vacuum relief valve located upstream from the check valve, with exhaust or relief piping terminating in a down-turned position at least 18 inches above the floor and covered with a corrosion-resistant screen.

C. Gauges. Each pump shall have a standard pressure gauge on its discharge line capable of displaying the maximum allowable pressure of the pump and shall have a standard pressure gauge or a compound gauge when appropriate on its suction line.

D. Meters.

1. All booster pump stations located within the distribution system should be fitted with a flow rate indicating and totalizing meter with recording capabilities.

2. A totalizing water meter to measure water production shall be provided for each well and shall be located upstream of the well blowoff.

E. Additional requirements for well discharge piping.

1. Valves shall be provided to allow testing and control of each well.

2. A nonthreaded sampling tap shall be provided for water sampling that discharges in a downward direction and away from the well casing.

3. A standard pressure gauge shall be provided to indicate well discharge pressure. The gauge shall be capable of displaying pressure under all operating conditions.

4. Blowoff.

a. A separate means to pump (i.e., blowoff) water of unsatisfactory quality to a point away from the groundwater source shall be provided. Blowoff discharge shall not create a cross-connection.

b. Systems shall be equipped with a watertight cap or a screened discharge.

c. Erosion protection at the point of waste discharge shall be provided.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1070 (Repealed.)

History

• Historical Notes: Derived from VR355-18-010.07 § 3.44, eff. August 1, 1991; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

Article 5 Finished Water Storage Structures

12VAC5-590-1080 Basic finished water storage structure design criteria

A. The materials and designs used for finished water storage structures, including associated pipe and valves, shall provide stability and durability as well as protect the quality of the stored water. Steel, concrete, composite, and plastic storage structures shall be designed, constructed, cleaned, disinfected, and tested in accordance with the following AWWA standards, where applicable: D100-11, D103-19, D107-16, D108-19, D110-13, D115-20, D120-19, D121-12, and C652-19.

B. Safety cages, rest platforms, roof-ladder handrails, and other safety devices shall be provided as required by VOSH laws and regulations.

C. Location of finished water storage structures.

1. The bottom of ground-level reservoirs, storage tanks, and standpipes should be placed above finished grade to ensure positive drainage away from the structure.

2. Where the bottom must be below normal ground surface, it shall be placed above the groundwater table. Sewers, drains, standing water, and similar sources of contamination shall be kept at least 50 feet from the finished water storage structure. Pipe conforming to water distribution pipe standards of 12VAC5-590-1110, pressure tested in place without leakage, shall be used for gravity sewers at lesser separations.

3. The top of all storage facilities shall not be less than two feet above the normal ground surface and shall be above the 100-year flood elevation. Any clearwell constructed under filters may be exempted from this requirement when the total design gives the same protection.

D. Pressure variation. The maximum variation between normal operational high and low water levels in finished water storage structures which float on a distribution system shall not exceed 30 feet.

E. Level controls.

1. Adequate controls shall be provided to enable sufficient tank turnover, water quality maintenance, avoidance of overflows, and efficient operations.

2. A telemetery system with recording capability shall be considered to transmit the operating levels in distribution system storage facilities to a location where qualified personnel may access the data at all times.

3. Altitude valves or equivalent controls shall be provided.

4. For tanks with a monitoring system, warnings or alarms indicating overflow, low level, and pump malfunction shall be provided.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-011.01 § 3.45, eff. August 1, 1991; amended, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1081 Atmospheric tank storage

A. Protection.

1. All finished water storage structures shall have suitable watertight roofs or covers that exclude birds, animals, and insects.

2. All finished water storage structures shall be designed to prevent vandalism and entrance by animals or unauthorized persons.

B. Finished water storage structures shall be designed to facilitate turnover of water. Consideration shall be given to locating inlet and outlet pipes at different elevations and locations, tank mixers, and other acceptable means to avoid stagnation. Excessive storage capacity shall be avoided to prevent water quality deterioration. See 12VAC5-590-640 B 3.

C. Drains.

1. No drain on a finished water storage structure shall create a cross-connection hazard.

2. All finished water storage structures shall be equipped with separate drains discharging to the atmosphere. Drainage of finished water storage structures to the distribution system through inlet and outlet piping is prohibited.

D. Overflows.

1. Finished water storage structures shall be provided with a downward-discharging, screened overflow pipe. The discharge pipe shall be brought down near the ground surface and into a drainage inlet structure or a splash plate that will divert the overflow away from the storage structure. The overflow pipe discharge shall be high enough above normal or graded ground surface to prevent the entrance of surface water.

2. Overflow pipe screens shall be installed so as to withstand the force of overflows. Properly designed flapper valves or rubber flex-type valves may be used instead of screens if approved by the department.

E. Inlet and discharge pipes.

1. Elevated tanks with riser pipes over eight inches in diameter shall have protective bars over the riser opening inside the tank.

2. Inlet and outlet pipes from water storage facilities shall be located in a manner that will prevent the flow of sediment into the distribution system.

F. Finished water storage structures shall be designed with convenient access to the interior for cleaning and maintenance. Ladders, ladder guards, balcony railings, and safely located entrance hatches shall be provided where applicable. Hatches, manholes, or scuttles above the waterline shall be:

1. Framed at least four inches, preferably six inches, above the surface of the roof at the opening; on ground-level structures, manholes should be elevated 24 to 36 inches above finished grade;

2. Fitted with a solid watertight cover that overlaps the framed opening and extends vertically down around the frame at least two inches (shoebox type);

3. Hinged at one side; and

4. Fitted with a locking device.

G. Finished water storage structures shall be vented by separate vent structures. Open construction between the side wall and roof is prohibited.

1. Vents shall prevent the entrance of surface water.

2. Vents shall exclude birds, animals, and insects and be constructed of noncorrodible material. Screens shall be designed to be frost-free or capable of relieving pressure or vacuum in the event of frosting or clogging.

3. Vents on ground-level structures shall terminate in an inverted U construction, with the vent terminating 24 to 36 inches above roof or finished grade.

H. Penetrations. The roof and sidewalls of all structures shall be watertight with no openings except properly constructed vents, manholes, overflows, risers, drains, pump mountings, control ports, or piping for inflow and outflow.

1. All pipes running through the roof or sidewall of a finished water storage structure shall be welded or properly gasketed in metal tanks or should be connected to standard wall castings that were placed during the forming of a concrete structure; these wall castings shall have flanges imbedded in the concrete.

2. Valves and controls shall be located outside the finished water storage structure so that valve stems and similar projections will not pass through the roof or top of the structure.

3. Downspout pipes for roof drainage shall not enter or pass through the structure.

I. All finished water storage structures and their appurtenances, especially the riser pipes, overflows, and vents shall be designed to prevent freezing that will interfere with proper functioning.

J. Every catwalk over finished water in a storage structure shall have a solid floor with raised edges designed so that shoe scrapings and dirt will not fall into the water.

K. The area surrounding a ground-level structure shall be graded in a manner that will prevent surface water from standing within 50 feet of the structure.

L. Proper protection shall be given to metal surfaces by paints or other protective coatings, by cathodic protective devices, or both, in accordance with the NSF/ANSI/CAN Standard 61-2020, AWWA Standards D102-17, D104-17, and D106-20, or an approved equivalent, where applicable.

M. All finished water storage facilities shall be cleaned to remove all dirt and loose materials before disinfection of the structure. Only potable water shall be used to clean and rinse the water storage facilities. All equipment including brooms, brushes, spray equipment, and worker's boots shall be disinfected before they are used to clean the storage facilities.

N. Disinfection. All finished water storage facilities shall be satisfactorily disinfected in accordance with AWWA Standard C652-19 before being placed in operation. The disinfection of the storage facilities shall be repeated until it is determined, by bacteriological testing, that the water is free of coliform bacteria.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1082 Pressure tank storage

A. When hydropneumatic tanks are used, they shall comply with the requirements of state and local laws and regulations for the construction and installation of unfired pressure vessels.

B. Pressure tanks shall be located above the normal ground surface with the operating end of the tank containing the inlet pipe, the pressure gauge, and other appurtenances projecting into a building with climate controls to prevent freezing. Alternatively, it may be completely housed, if adequate access is provided for inspection, removal, and replacement.

C. Pressure tanks shall have bypass piping to permit operation of the system while the tank is being cleaned, repaired, or painted.

D. Pressure tanks shall have an access manway, a drain, and control equipment consisting of a pressure gauge, water sight glass, automatic or manual air blowoff, pressure and vacuum relief valves, and mechanical means for adding air. Pressure tanks smaller than than 120 gallons and bladder tanks are not required to have an access manway, sight glass, or vacuum relief valve.

E. Pressure tanks and pumps shall be designed to minimize pump cycling and to operate within manufacturer recommendations.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1090 Plant storage

A. Backwash water storage tanks shall be sized in conjunction with available pump units and finished water storage to provide the filter backwash water required. Consideration shall be given to the possibility of having to wash more than one filter at a time or several filters in succession.

B. Clearwell storage shall be sized, in conjunction with distribution system storage, to relieve the filters from having to follow fluctuations in water use or meet peak demands, including filter backwash water. When finished water storage is used to provide proper contact time for disinfection, special attention shall be given to size, drawdown, and baffling. Plant clearwells shall be equipped with a raised viewing port having a clear glass or plastic viewing window and a submerged, waterproofed electric light.

C. Finished water shall not be stored or conveyed in a compartment adjacent to nonpotable water when the two compartments are separated by a single wall.

D. Receiving basins and pump wet wells for finished water shall be designed as finished water storage structures.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-011.02 § 3.46, eff. August 1, 1991; amended, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1100 (Repealed.)

History

• Historical Notes: Derived from VR355-18-011.03 § 3.47, eff. August 1, 1991; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

Article 6 Water Distribution Systems [Repealed]

12VAC5-590-1110 Distribution system materials

Pipe, fittings, joints, valves, hydrants, and coatings shall conform to AWWA standards.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-012.01 § 3.48, eff. August 1, 1991; amended, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1120 Minimum pipe size

A. The minimum size pipe for water distribution mains shall be four inches in diameter. Pipes of lesser diameter may be used in the following instances:

1. When the run is less than 300 feet, two-inch diameter pipe may be used.

2. When the run is less than 600 feet but more than 300 feet, three-inch diameter pipe may be used.

3. Any departure in sizing shall be justified by hydraulic analysis and future water demands.

B. Fire hydrants shall not be connected to water mains that are not designed to carry fire flows. Connection of a fire hydrant to a pipe of less than six inches in diameter is prohibited.

C. Where a noncommunity waterworks serves a single building, the plumbing shall be in accordance with the USBC. Where a noncommunity waterworks serves two or more buildings, the pipe shall be of sufficient size to provide adequate flow and pressure in order to meet the system demands.

History

• Statutory Authority: § 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-012.02 § 3.49, eff. August 1, 1991; amended, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1130 Distribution system design

A. Dead-ends should be minimized by the looping of water mains.

B. Where dead-end water mains occur, a means of effective flushing shall be provided.

C. No flushing device shall be directly connected to any sewer.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-012.03 § 3.50, eff. August 1, 1991; amended, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1140 Installation and testing of water mains

A. Adequate supports and restraints shall be provided for all pipes.

B. A continuous and uniform bedding shall be provided in the trench for all buried pipe.

C. Stones and rocks found in the trench shall be removed to a depth of at least six inches below the bottom of the pipe and selected fill bedding provided.

D. Installed pipe shall be pressure-tested and meet allowable leakage as specified in accordance with AWWA Standards C600-17, C604-17, and C605-13, where applicable.

E. Any plastic or other nonmetallic pressurized pipe installed underground shall be provided with a material conductive of electricity or some other means of locating the buried pipe.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-012.04 § 3.51, eff. August 1, 1991; amended, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1150 Separation of water mains and sanitary sewers

A. The following factors shall be considered in providing adequate separation of water mains and sanitary sewers:

1. Materials and types of joints for water and sanitary sewer mains;

2. Soil conditions;

3. Service branch connections into the water main and sanitary sewer mains;

4. Compensating variations in the horizontal and vertical separations;

5. Space for repairs and alterations of water and sanitary sewer mains;

6. Offsetting of pipes around manholes; and

7. Identification of the physical restraints preventing normal separation.

B. Parallel installation of water mains and sanitary sewers.

1. Under normal conditions, water mains shall be laid at least 10 feet horizontally from a sanitary sewer or sewer manhole. The distance shall be measured edge-to-edge.

2. Under unusual situations when local conditions prevent a horizontal separation of 10 feet, the water main may be laid closer to a sanitary sewer or sewer manhole provided that:

a. The bottom (invert) of the water main shall be at least 18 inches above the top (crown) of the sanitary sewer;

b. Where this vertical separation cannot be obtained, the sanitary sewer shall be constructed of water distribution pipe and pressure tested in place in accordance with 12VAC5-590-1110 and 12VAC5-590-1140;

c. The department may approve concrete encasement of the water main or other physical barrier;

d. The sewer manhole shall be of watertight construction and tested in place; and

e. No water pipes shall pass through or come into contact with any part of a sewer manhole.

C. Crossing of water mains and sanitary sewers.

1. Under normal conditions, water mains crossing sanitary sewers shall be laid to provide a separation of at least 18 inches between the bottom of the water main and the top of the sanitary sewer whenever possible.

2. Under unusual situations when local conditions prevent a vertical separation described in subdivision C 1 of this section, the following construction shall be used:

a. Sanitary sewers passing over or under water mains shall be constructed of the materials described in subsection B of this section and shall be constructed to a point 10 feet beyond and on each side of the crossing; and

b. Water mains passing under sanitary sewers shall, in addition, be protected by providing:

(1) A vertical separation of at least 18 inches between the bottom of the sanitary sewer and the top of the water main;

(2) Adequate structural support for the sanitary sewers to prevent excessive deflection of the joints and the settling on and breaking of the water main; and

(3) That the length of the water main be centered at the point of the crossing so that joints shall be equidistant and as far as possible from the sanitary sewer.

D. The minimum horizontal separation distance between water mains and septic tanks and drainfields, measured edge-to-edge, shall be 10 feet. Greater separation distances shall be provided wherever practical.

E. Water mains shall be located a safe horizontal distance from sources of contamination not already mentioned in this section, such as sewage treatment works and industrial complexes. The owner's engineer shall contact the department to determine the safe separation distances.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-012.05 § 3.52, eff. August 1, 1991; amended, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1160 Valve, air relief, meter, and blowoff chambers

A. Standard fire hydrants or blowoffs shall be considered to enable removal of sediment and air accumulations.

B. Drains in chambers or pits that contain valves, blowoffs, meters, or other appurtenances to a distribution system shall not be connected directly to any storm drain or sanitary sewer, nor shall blowoffs or air relief valves be connected directly to any sanitary sewer.

C. Chambers or pits shall be drained to the surface of the ground where they are not subject to flooding by surface water or to absorption pits located above the seasonal groundwater table elevation. The backfill material for the water main may serve as an absorption pit if granular embedment material is laid from the pipe bedding up through the final backfill layer for the entire length of pipe in the chamber. Sump pumps may be used where other means are not practicable.

D. Chambers or pits shall be designed to facilitate air-valve inspection and servicing.

E. Air relief and blowoff piping.

1. The open end of an air relief pipe shall be extended from the manhole or enclosing chamber to a point at least one foot above ground and provided with a screened, downward facing elbow. The exposed pipe and appurtenances shall be protected from vandalism and other damage.

2. When an aboveground extension is not practical or desired, the open end of the air relief pipe or blowoff shall be extended.

a. Where the pit or chamber is provided with proper drainage and is not otherwise subject to high groundwater levels, surface flooding, ponding, and contaminant or pollutant spills, the open end may be provided with a screened, downward facing elbow. The valve chamber or pit shall be vented to provide sufficient air flow to allow proper operation of the air valve. Air valves fitted with a smooth vent port and screened hood are allowable under these conditions.

b. Where the pit or chamber is not properly drained or is otherwise subject to high groundwater levels, surface flooding, ponding, and contaminant or pollutant spills, a manually operated valve or blowoff shall be used and the open end shall be fitted with a watertight cap or other means to prevent contamination from entering the pipe and valve.

c. The installation and testing specifications shall require field verification by the owner's engineer of the groundwater elevation and surface water drainage, as needed in circumstances or situations where this is of potential concern, before placement of the pit or chamber.

History

• Statutory Authority: § 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-012.06 § 3.53, eff. August 1, 1991; amended, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1170 Hydrants

A. Fire hydrants.

1. To avoid cross-connection and contamination, dry barrel fire hydrants:

a. Should be located in areas that are not subject to high groundwater, flooding, surface water ponding, and contaminant or pollutant spills. When this is not practical, consideration shall be given to:

(1) Piping the drain port to daylight with screening on the end of the pipe; or

(2) Plugging the drain port and marking the hydrant for seasonal dewatering.

b. Shall comply with the ANSI/AWWA C502-18 standard, to include drain ports that are physically isolated from the drinking water system by the hydrant stem valve; and

c. Shall be drained to the ground surface or to a dry well provided exclusively for this purpose. Fire hydrant drains shall not be connected to sanitary sewers or storm drains.

2. Fire hydrants shall be connected only to water mains adequately designed for fire flows in accordance with the requirements of 12VAC5-590-1120 B.

B. Yard hydrants.

1. Shall have a hose connection vacuum breaker, meeting ASSE 1011-2017 or ASSE 1052-2016, if the hydrant has hose threads and is not already protected with an integral vacuum breaker.

2. To avoid cross-connection and contamination, yard hydrants installed in areas subject to high groundwater, flooding, contaminant, or pollutant spills or in areas where surface water ponds shall:

a. Meet ASSE 1057-2012, Performance Requirements for Freeze Resistant Sanitary Yard Hydrants with Backflow Protection; or

b. Have hydrant drain ports that are piped to daylight with screening on the end of the pipe; or

c. Be contained from the rest of the distribution system by a backflow prevention assembly suitable for a high hazard.

3. Frost-proof yard hydrants with weep holes draining below grade are allowed provided they are not installed in areas subject to high groundwater, to flooding, or to contaminant or pollutant spills or in areas where surface water ponds.

C. Hydrants and flushing devices not designed for fire protection may be connected to pipe of less than six inches in diameter, consistent with 12VAC5-590-1120 A.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-012.07 § 3.54, eff. August 1, 1991; amended, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1180 Surface water crossings

A. Surface water crossings, both over and under water, present special challenges and shall be discussed with the department before project documents are prepared.

B. Aerial water crossings. The pipe above water crossings shall be:

1. Adequately supported;

2. Protected from freeze damage;

3. Accessible for repair or replacement; and

4. Above the 100-year flood elevation.

C. Under water crossings.

1. The pipe shall be of special construction, suitable to the method of installation and having flexible watertight joints.

2. Where rigid pipe is used, valves and taps shall be provided at both ends of the water crossing so that the section can be isolated for tests or repair; the valves and taps shall be easily accessible and not subject to flooding.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-012.08 § 3.55, eff. August 1, 1991; amended, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1190 (Repealed.)

History

• Historical Notes: Derived from VR355-18-012.09 § 3.56, eff. August 1, 1991; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1200 (Repealed.)

History

• Historical Notes: Derived from VR355-18-012.10 § 3.57, eff. August 1, 1991; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1210 Disinfection and testing of water mains

A. All water mains shall be disinfected in accordance with AWWA Standard C651-14 before being placed in operation. The disinfection of the mains shall be repeated until it is determined by bacteriological testing that the water is free of coliform bacteria.

B. Project documents shall provide the details of the procedure and include the disinfectant application technique, dosage, contact time, method of testing the results of the procedure, and use or disposal of the disinfecting water.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-012.11 § 3.58, eff. August 1, 1991; amended, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1220 Pipe cover

All buried distribution pipe shall be provided with sufficient earth or other suitable cover or encasement to prevent from freezing and provide protection from damage by external forces.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-01212 § 3.59, eff. August 1, 1991; amended, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1230 Service connection metering

A. All new service connections in community waterworks shall be metered.

B. Water pipe and appurtenances between the water main and the service connection shall conform to all applicable codes.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from VR355-18-01213 § 3.60, eff. August 1, 1991; amended, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1235 Water loading stations

A. The station and its piping and valving arrangement shall be designed to prevent unauthorized use, tampering, and vandalism.

B. An air gap or RPZ assembly shall be provided on the potable water fill connection to prevent backflow into the waterworks.

C. The piping and valving arrangement shall prevent contaminants from being transferred from a hauling tank or vessel to others subsequently using the water loading station.

D. Hoses used to fill potable water tanks and vessels shall be approved for potable water contact.

E. Hoses shall not come into contact with the ground or other contaminated surface and shall otherwise be handled, maintained, and stored in a manner to prevent contamination.

History

• Statutory Authority: §§ 32.1-12 and 32.1-170 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1240 (Repealed.)

History

• Historical Notes: Derived from VR355-18-013.01 § 4.1, eff. August 1, 1991; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1250 (Repealed.)

History

• Historical Notes: Derived from VR355-18-013.02 § 4.2, eff. August 1, 1991; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1260 (Repealed.)

History

• Historical Notes: Derived from VR355-18-013.03 § 4.3, eff. August 1, 1991; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1270 (Repealed.)

History

• Historical Notes: Derived from VR355-18-013.04 § 4.4, eff. August 1, 1991; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

12VAC5-590-1280 (Repealed.)

History

• Historical Notes: Derived from VR355-18-013.05 § 4.5, eff. August 1, 1991; repealed, Virginia Register Volume 37, Issue 20, eff. June 23, 2021.

Chapter 610 Sewage Handling and Disposal Regulations

Part I General Framework for Regulations Article 1 General Provisions

12VAC5-610-20 Purpose of regulations

This chapter has been promulgated by the State Board of Health to:

1. Assure that all sewage is handled and disposed of in a safe and sanitary manner;

2. Guide the State Health Commissioner in his determination of whether a permit for handling or disposing of sewage should be issued or denied; and

3. Guide the owner in the requirements necessary to secure a permit for handling and disposing of sewage.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 1.2, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-30 Relationship to other regulations

A. This chapter addresses the handling and disposal of those portions of sewage flows not regulated by a Virginia Pollutant Discharge Elimination System (VPDES) Permit or a Virginia Pollutant Abatement (VPA) Permit issued in accordance with 9VAC25-31 or 9VAC25-32, respectively.

B. Reclamation and reuse of sewage may be subject to permitting by the Department of Environmental Quality under 9VAC25-740.

History

• Statutory Authority: §§ 32.1-12, 32.1-164, and 32.1-164.9 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 1.3, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-610-40 Administration of regulations

This chapter is administered by the following:

1. State Board of Health. The State Board of Health, hereinafter referred to as the board, has the responsibility to promulgate, amend, and repeal regulations necessary to ensure the safe and sanitary handling and disposal of sewage.

2. State Health Commissioner. The State Health Commissioner, hereinafter referred to as the commissioner, is the chief executive officer of the State Department of Health. The commissioner has the authority to act, within the scope of regulations promulgated by the board, for the board when it is not in session. The commissioner may delegate his powers under this chapter with the exception of his power to issue orders under § 32.1-26 of the Code of Virginia and 12VAC5-610-170 B. The commissioner has final authority to adjudicate contested decisions of subordinate delegated powers under this section prior to appeal of such decisions to the circuit court.

3. State Department of Health. The State Department of Health, hereinafter referred to as the department, is designated as the primary agent of the commissioner for the purpose of administering this chapter.

4. District or local health departments. The district or local health departments are responsible for implementing and enforcing the operational activities as required by this chapter.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 1.4, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-50 Sewage Handling and Disposal Advisory Committee

The commissioner shall appoint a Sewage Handling and Disposal Advisory Committee consisting of 16 appointed members and five ex officio members. The commissioner shall appoint to the Sewage Handling and Disposal Advisory Committee one individual each from the following: a member of the Virginia Society of Professional Engineers; a member of the Consulting Engineers Council of Virginia; a member of the Virginia Association of Professional Soil Scientists; a member of the Home Builders Association of Virginia; a member of the Virginia Association of Counties; a member of the Virginia Municipal League; a member of the Virginia Association of Realtors; a member of the Virginia Section, America Institute of Professional Geologists; a member of the Virginia Well Drillers Association; a member of the Virginia Water Environment Association; a faculty member of a Virginia state university or college whose principal field of teaching is soil science; a member of the Virginia Environmental Health Association; a member of the Virginia Wastewater Association; a member of the Virginia Coalition of Environmental Associations and two citizens at large. Ex officio members shall consist of the Director, Division of Wastewater Engineering; an environmental engineer from Chesapeake Bay Local Assistance Department; a person with nonpoint source experience from the Department of Conservation and Recreation; Director, Bureau of Applied Technology, Department of Environmental Quality; and the Director, Division of Onsite Sewage; and Water Services; or their designees. The chairman shall be designated by the commissioner.

Appointed members shall serve at the discretion of the commissioner with terms being two years in duration. The Sewage Handling and Disposal Advisory Committee shall make recommendations to the commissioner regarding sewage handling and disposal policies, procedures and programs of the department. The committee shall meet at least annually. The committee shall establish its rules of order.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 1.5, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-60 The State Health Department Sewage Handling and Disposal Appeals Review Board

There is established within the Department of Health under § 32.1-166.1 the Sewage Handling and Disposal Appeals Review Board, hereinafter referred to as the Appeals Review Board.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 1.6, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-70 Grandfather clause

A. Any owner of a grandfathered lot may submit an application for a construction permit according to the procedure in 12VAC5-610-250. The local health department may perform a site and soil evaluation in accordance with Part III (12VAC5-610-450 et seq.) of this chapter and a permit shall be issued for a system which complies to the greatest extent possible with this chapter provided that the site and soil conditions would not preclude the successful operation of the system. Whenever the site and soil conditions on a grandfathered lot do not substantially comply with the requirements in Part IV (12VAC5-610-591 et seq.) of this chapter for a septic tank effluent system, secondary treatment will be required in the system design. In no case may the separation distance between the subsurface absorption system and a drinking water supply be less than the separation distance established in the regulations in effect at the time the grandfathered lot was approved (subdivision approval) or when the first permit was issued for the grandfathered lot.

B. Certification letters may not be issued in lieu of permits under the grandfather clause.

C. All permits issued under the grandfather clause which do not substantially comply with the provisions of this chapter shall be considered conditional permits in accordance with 12VAC5-610-250 J. A statement approved by the division shall be recorded and indexed in the grantor index of the land records of the circuit court having jurisdiction over the site of the sewage treatment and disposal system. The statement shall indicate that the permit is issued under the grandfather clause and that the site and soil conditions do not substantially comply with the current regulations and may contain such other information as the division deems appropriate to serve notice to future owners of the unique nature of grandfathered lots.

D. Within 18 months of July 1, 2000, any owner of a lot for which a certification letter or subdivision approval was issued after November 1, 1982, may submit an application for a construction permit according to the procedures in 12VAC5-610-250. Such application shall be subject to the permitting requirements of the regulations under which the certification letter or subdivision approval was issued.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 1.7, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-75 Permits valid on the effective date of this chapter

Sewage disposal system construction permits which are valid on July 1, 2000, shall be automatically renewed on a one-time basis. Each permit thus renewed shall have an expiration date 18 months from the expiration date shown on the face of the permit. Such permits may be converted to certification letters only if they substantially comply with the current provisions of this chapter.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-80 Sewerage systems and/or treatment works required

A. The discharge of untreated sewage onto the land or into the waters of the Commonwealth is prohibited.

B. No owner, person, or occupant shall discharge treated or untreated sewage onto the land, into the soil or into the waters of the Commonwealth without a valid permit from the commissioner or, as appropriate, a certificate issued by the Department of Environmental Quality in accordance with Title 62.1 of the Code of Virginia.

C. All buildings, residences, and structures designed for human occupancy, employment or habitation and other places where humans congregate shall be served by an approved sewerage system and/or treatment works. An approved sewerage system or treatment works is a system for which a certificate to operate has been issued jointly by the department and the Department of Environmental Quality or a system which has been issued a separate permit by the commissioner.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 1.8, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-90 (Repealed.)

Historical Notes

Derived from VR355-34-02 § 1.9, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14,Virginia Register Volume 4, Issue 14, eff. May 11, 1988; repealed, Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-100 Right of entry

The commissioner or his designee shall have the right to enter any property to assure compliance with this chapter in accordance with the provisions of § 32.1-25 of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 1.10, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-110 (Repealed.)

Historical Notes

Derived from VR355-34-02 § 1.11, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; repealed, Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-120 Definitions

The following words and terms when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise:

"Agent" means a legally authorized representative of the owner.

"Alluvial soil" means a soil developing from recently deposited alluvium and exhibiting essentially no horizon development or modification of the recently deposited materials.

"Alluvium" means mineral materials, either weathered or unweathered, that are transported by flowing water and deposited or redeposited in a flood-plain or marine terrace.

"Aquifer" means water-bearing portion of a geologic formation that transmits water.

"Biochemical oxygen demand, five-day" or "BOD₅" means the quantitative measure of the amount of oxygen consumed by bacteria while stabilizing, digesting, or treating biodegradable organic matter under aerobic conditions over a five-day incubation period; BOD₅ is expressed in milligrams per liter (mg/l).

"Certification letter" means a letter issued by the commissioner, in lieu of a construction permit, that identifies a specific site and recognizes the appropriateness of the site for an onsite wastewater disposal system.

"Colluvial soil" means a soil developing from recently deposited colluvium and exhibiting essentially no horizon development or modification of the recently deposited materials.

"Colluvium" means an accumulation of soil material, or a mixture of stone fragments and soil material, deposited at the base of slopes or in depressional areas, primarily by gravity.

"Commissioner" means the State Health Commissioner or his subordinate who has been delegated powers in accordance with subdivision 2 of 12VAC5-610-40.

"Cr horizon" means weathered or soft bedrock and is used to indicate root restrictive layers or bedrock or saprolite.

"Dilution area" means the land immediately adjacent to and down gradient, in the direction of ground water flow, from a mass sewage disposal system, that is provided for the purpose of diluting nitrogen, or other nutrients occurring in wastewater, with ambient ground water, in order to assure compliance with nutrient standards contained in this chapter.

"District health department" means a consolidation of local health departments as authorized in § 32.1-31 C of the Code of Virginia.

"Division" means the Division of Onsite Sewage and Water Services, Office of Environmental Health Services, State Health Department, or its administrative successor.

"Existing construction" (with failing sewage disposal systems) means an existing structure where the sewage disposal system serving the structure has failed or is currently in violation of state law or regulations and requires correction.

"General approval" means approval granted to systems that are proven and tested in accordance with Article 2 (12VAC5-610-441 et seq.) of Part II of this chapter.

"Grandfathered lot" means:

1. Any lot upon which no permit has been issued and which is in a subdivision approved by the department prior to July 1, 2000, in accordance with a local subdivision ordinance. Individual lots may or may not have been evaluated; or

2. Any lot, parcel, or portion thereof with a previously issued permit or a specific written approval (not including a certification letter) from the department.

"Gray color" means a chroma-2 or less on the Munsell Color Chart.

"Impervious strata" means soil or soil materials with an estimated or measured percolation rate in excess of 120 minutes per inch.

"Infiltrative surface" means the designated interface where effluent moves from distribution piping, media, and fill to natural soil.

"Local health department" means a branch of the State Health Department established in each city and county in accordance with § 32.1-30 of the Code of Virginia.

"Mass sewage disposal system" means a sewage disposal system or systems that will discharge effluent to a single absorption area or multiple absorption areas with or without combined flows, such that the loading rate applied to any acre, as determined by the department, exceeds 1,200 gallons per day.

"Mineral soil" means a soil consisting predominantly of, and having its properties determined predominantly by, mineral matter. A mineral soil usually contains less than 20% organic matter, but it may contain an organic surface layer up to 12 inches thick.

"New construction" means construction of a building for which a building permit is required.

"Office" means the Office of Environmental Health Services, State Health Department.

"Owner" means the Commonwealth or any of its political subdivisions, including sanitary districts, sanitation district commissions and authorities, any individual, any group of individuals acting individually or as a group, or any public or private institution, corporation, company, partnership, firm, or association which owns or proposes to own a sewerage system or treatment works.

"Person" means an individual, corporation, partnership, association, or any other legal entity.

"Previously issued permit" means any permit issued prior to July 1, 2000, and in accordance with the regulations in effect at the time the permit was issued. There is no distinction between an expired permit and one that has been continually renewed.

"Pump and haul" means any unusual circumstance wherein sewage is permitted to be transported by vehicle to a point of disposal. The term "pump and haul" includes all facilities and appurtenances necessary to collect and store the sewage for handling by a contractor having a valid sewage handling permit.

"Rock" or "bedrock" means continuous, coherent, lithologic material that has relative hardness depending on the degree of weathering. Bedrock has characteristics such as strike, dip, jointing, and lithological compositions. Structure and water movement are rock controlled. Bedrock grinds with an auger, and mechanical penetration is more difficult or prevented as the material gets harder.

"Saprolite" means material weathered from igneous or metamorphic rock, without soil structure, and with remnant structure and fabric of the parent rock which is soft in place and can be penetrated easily with an auger.

"Secondary effluent" means effluent treated to reduce five-day biochemical oxygen demand to 30 mg/l or less, total suspended solids to 30 mg/l or less, and fats, oils, and grease to less than 5 mg/l.

"Septic tank effluent" means effluent characterized by a five-day biochemical oxygen demand between 120 and 200 mg/l; total suspended solids between 70 and 150 mg/l; fats, oils, and grease of 30 mg/l or less; and having no other toxic, hazardous, or constituents not routinely found in residential wastewater flows.

"Septage" means the mat of grease and scum on the surface of septic tanks, the accumulated sludge at the bottom of tanks and the sewage present at the time of pumping.

"Sewage" means water-carried and nonwater-carried human excrement, kitchen, laundry, shower, bath, or lavatory wastes separately or together with such underground, surface, storm, or other water and liquid industrial wastes as may be present from residences, buildings, vehicles, industrial establishments, or other places.

"Sewage disposal system" means a sewerage system or treatment works designed not to result in a point source discharge.

"Sewage handler" means any person who removes or contracts to remove and transports by vehicle the contents of any septic tank, sewage treatment plant, privy, holding tank, portable toilet, or any sewage, septage, or sewage sludges that have been processed to meet acceptable treatment standards as defined in this chapter or the Sewage Regulations (12VAC5-580-10 et seq.).

"Sewage handling" means the vehicular conveyance of sewage (See "Transportation" in § 32.1-163 of the Code of Virginia).

"Sewerage system" means pipe lines or conduits, pumping stations and force mains and all other construction, devices, and appliances appurtenant thereto, used for the collection and conveyance of sewage to a treatment works or point of ultimate disposal.

"Shrink-swell soils" means soils with horizons that contain montmorillonite and other clays that excessively shrink upon drying and swell upon wetting.

"Sink hole" means a depression in the topography without a surface outlet for drainage from the low point. Sink holes are common in areas containing limestone and generally result from the collapse of solution cavities.

"Soil" means the weathered mineral and organic fraction of the earth's regolith, which is less than or equal to 2.0 mm in size as observed in place. Soil comprises sands, silts, or clays or combinations of these textured components and may contain larger aggregate materials such as gravel, cobbles, stones, or channers or precipitates from aqueous solution. Soil includes the A, O, B, C, and E horizons.

"Soil horizon" means a layer of soil or soil material approximately parallel to the land surface and different from adjacent genetically related layers in physical, chemical, and biological properties or characteristics such as color, structure, texture, consistency, kinds, and numbers of organisms present, degree of acidity or alkalinity, etc.

"Subdivision" means multiple building lots derived from a parcel or parcels of land.

"Subsurface soil absorption" means a process which utilizes the soil to treat and dispose of effluent from a treatment works. (Also see "Subsurface drainfield" in § 32.1-163 of the Code of Virginia).

"Total suspended solids" or "TSS" means a measure of the mass of all suspended solids in a sample typically measured in milligrams per liter (mg/l).

"Treatment level 2 effluent" or "TL-2 effluent" means secondary effluent as defined in this section that has been treated to produce BOD₅ and TSS concentrations equal to or less than 30 mg/l each.

"Treatment level 3 effluent" or "TL-3 effluent" means effluent that has been treated to produce BOD₅ and TSS concentrations equal to or less than 10 mg/l each.

"Treatment unit" or "treatment system" means a method, technique, equipment, or process other than a septic tank used to treat sewage to produce effluent of a specified quality before the effluent is dispersed to a soil treatment area.

"Treatment works" means any device or system used in the storage, treatment, disposal, or reclamation of sewage or combinations of sewage and industrial wastes, including pumping, power, and other equipment and appurtenances, septic tanks, and any works, including land, that are or will be (i) an integral part of the treatment process or (ii) used for ultimate disposal of residues or effluent resulting from such treatment.

"Working volume" means the volume in a pump tank between the pump off level and the high water alarm level.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 1.12, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000; Volume 39, Issue 4, eff. November 24, 2022.

12VAC5-610-130 Compliance with Virginia Administrative Process Act

The provisions of the Virginia Administrative Process Act of the Code of Virginia shall govern the promulgation and administration of this chapter and shall be applicable to the appeal of any case decision based upon this chapter.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 2.1, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-140 (Repealed.)

Historical Notes

Derived from VR355-34-02 §§ 2.2 and 2.3, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; repealed, Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-160 Emergency order or rule

If an emergency exists the commissioner may issue an emergency order or rule as is necessary for preservation of public health, safety, and welfare. The emergency order or rule shall state the reasons and precise factual basis upon which the emergency rule or order is issued. The emergency order or rule shall state the time period for which it is effective.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 2.4, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-170 Enforcement of regulations

All sewage handling and disposal facilities shall be constructed and operated in compliance with the requirements as set forth in this chapter. The commissioner may enforce this chapter through any means lawfully available.

A. Notice. Subject to the exceptions indicated below whenever the commissioner or the district or local health department has reason to believe a violation of any of these regulations has occurred or is occurring, the alleged violator shall be notified. Such notice shall be made in writing, shall be delivered personally or sent by certified mail, shall cite the regulation or regulations that are allegedly being violated, shall state the facts which form the basis for believing the violation has occurred or is occurring, shall include a request for a specific action by the recipient by a specified time and shall state the penalties associated with such violations (See § 32.1-27 of the Code of Virginia). When the commissioner deems it necessary he may initiate criminal prosecution or seek civil relief through mandamus or injunctive relief prior to giving notice.

B. Orders. Pursuant to the authority granted in § 32.1-26 of the Code of Virginia the commissioner may issue orders to require any owner to comply with the provisions of this chapter. The order shall be signed by the commissioner and may require:

1. The immediate cessation or correction, or both, of the violation;

2. The acquisition or use of additional land, equipment, supplies or personnel to assure that the violation does not recur;

3. The submission of a plan to prevent future violations to the commissioner for review and approval;

4. The submission of an application for a variance; and

5. Any other corrective action deemed necessary for proper compliance with the regulations.

C. Hearing before the issuance of an order. Before the issuance of an order described in subsection B of this section, a hearing must be held with at least 30 days notice to the affected owner of the time, place and purpose thereof, for the purpose of adjudicating the alleged violation or violations of this chapter. The procedure at the hearing shall be in accordance with 12VAC5-610-200 B and with §§ 9-6.14:11 and 9-6.14:12 of the Code of Virginia.

D. Order; when effective. All orders shall become effective not less than 15 days after mailing a copy thereof by certified mail to the last known address of the owner violating this chapter. Violation of an order is a misdemeanor. (See § 32.1-27 of the Code of Virginia.)

E. Compliance with effective orders. The commissioner may enforce all orders. Should any owner fail to comply with any order, the commissioner may:

1. Apply to an appropriate court for an injunction or other legal process to prevent or stop any practice in violation of the order;

2. Seek mandamus against any owner that is a municipal corporation;

3. Request the Attorney General to bring an action for civil penalty;

4. Request the Commonwealth's Attorney to bring a criminal action.

F. Not exclusive means of enforcement. Nothing contained in this section shall be interpreted to require the commissioner to issue an order prior to seeking enforcement of any regulations or statute through an injunction, mandamus or criminal prosecution.

G. Suspension of regulations during disasters. If in the case of a man-made or natural disaster, the commissioner finds that certain regulations cannot be complied with and that the public health is better served by not fully complying with this chapter, he may authorize the suspension of the application of the regulations for specifically affected localities and institute a provisional regulatory plan until the disaster is abated.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 2.5, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-180 (Repealed.)

Historical Notes

Derived from VR355-34-02 § 2.6, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; repealed, Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-190 Variances

The commissioner may grant a variance to this chapter; however, minor deviations to the criteria contained in Part IV (12VAC5-610-591 et seq.) or Part V (12VAC5-610-660 et seq.) of this chapter may be granted in accordance with 12VAC5-610-280 C. The commissioner shall follow the appropriate procedures set forth in this section in granting a variance.

A. Definition of a variance. A variance is a conditional waiver of a specific regulation which is granted to a specific owner relating to a specific situation or facility and may be for a specified time period.

B. Requirements for a variance. The commissioner may grant a variance if a thorough investigation reveals that the hardship imposed (may be economic) by this chapter outweighs the benefits that may be received by the public and that the granting of such variance does not subject the public to unreasonable health risks.

C. Application for a variance. Any owner who seeks a variance shall apply in writing for a variance. The application shall be sent to the appropriate district and local health department for review and forwarding to the commissioner. The application shall include:

1. A citation to the regulation from which a variance is requested;

2. The nature and duration of the variance requested;

3. Any relevant analytical results including results of relevant tests conducted pursuant to the requirements of this chapter;

4. The hardship imposed by the specific requirement of this chapter;

5. A statement of reasons why the public health and welfare would be better served if the variance were granted;

6. Suggested conditions that might be imposed on the granting of a variance that would limit the detrimental impact on the public health and welfare;

7. Other information, if any, believed pertinent by the applicant; and

8. Such other information as the local health department and the commissioner may require.

D. Evaluation of a variance application.

1. The commissioner shall act on any variance request submitted pursuant to subsection C of this section within 60 calendar days of receipt of the request.

2. In the commissioner's evaluation of a variance application, the commissioner shall consider the following factors:

a. The effect that such a variance would have on the operation of the sewage handling or disposal facility;

b. The cost and other economic considerations imposed by this requirement;

c. The effect that such a variance would have on protection of the public health;

d. Any relevant analytical results including results of relevant tests conducted pursuant to the requirements of this chapter;

e. The hardship imposed by enforcing the specific requirement of this chapter;

f. The applicant's statement of reasons why the public health and welfare would be better served if the variance were granted;

g. The suggested conditions that might be imposed on the granting of a variance that would limit the detrimental impact on the public health and welfare;

h. Other information, if any, believed pertinent by the applicant;

i. Such other information as the local health department and the commissioner may require; and

j. Such other factors as the commissioner may deem appropriate.

E. Disposition of a variance request.

1. The commissioner may reject any applicant for a variance by sending a rejection notice to the applicant. The rejection notice shall be in writing and shall state reasons for the rejection. The application may petition for a hearing within 30 calendar days to challenge the rejection pursuant to 12VAC5-610-200.

2. If the commissioner proposes to grant a variance request submitted pursuant to subsection C of this section, the applicant shall be notified in writing of this decision. Such notice shall identify the variance, sewage handling or disposal facility covered, and shall specify the period of time for which the variance will be effective and any conditions imposed pursuant to issuing the variance. The effective date of a variance shall be 15 calendar days following its issuance.

3. No owner may challenge the terms set forth in the variance after 30 calendar days have elapsed from the date of issuance.

F. Posting of variances. All variances granted to any sewage handling or disposal facility are nontransferable. Each variance shall be attached to the permit to which it is granted. Each variance is revoked when the permit to which it is attached is revoked.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 2.7, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-200 Hearing types

Hearings before the board, commissioner or the commissioner's designees shall include any of the following forms depending on the nature of the controversy and the interests of the parties involved.

A. Informal hearings. An informal fact-finding proceeding is an informal conference between the department and the named party held in accordance with § 2.2-4019 of the Code of Virginia. The department shall consider all evidence presented at the meeting that is relevant to the issue in controversy. Presentation of evidence, however, is entirely voluntary. No verbatim record need be taken at the informal hearing. The department shall review the facts presented and based on those facts render a decision. If the decision is adverse to the interests of the appellant, an aggrieved appellant may request an adjudicatory hearing pursuant to 12VAC5-610-200 B.

B. Adjudicatory hearing for appeals of denials of sewage system construction permits. The adjudicatory hearing is a formal, public adjudicatory proceeding before the commissioner, the Sewage Handling and Disposal Appeal Review Board, or a designated hearing officer held in conformance with § 2.2-4020 of the Code of Virginia. An adjudicatory hearing includes the following features:

1. Notice. Notice that states the time and place and the issues involved in the prospective hearing shall be sent to the owner or the person who is the subject of the hearing. Notice shall be sent by certified mail at least 15 calendar days before the hearing is to take place.

2. Record. A verbatim record of the hearing shall be made by a court reporter. A copy of the transcript of the hearing, if transcribed, will be provided within a reasonable time to any person upon written request and payment of the cost.

3. Evidence. All interested parties shall attend the hearing and submit oral and documentary evidence and rebuttal proofs, expert or otherwise, that are material and relevant to the issues in controversy. The admissibility of evidence shall be determined in accordance with § 2.2-4020 of the Code of Virginia.

4. Counsel. All parties may be accompanied by and represented by counsel and are entitled to conduct such cross-examination as may elicit a full and fair disclosure of the facts.

5. Subpoena. Pursuant to § 2.2-4020 of the Code of Virginia, the commissioner, Sewage Handling and Disposal Appeal Board, or hearing officer may issue subpoenas on behalf of themselves for the attendance of witnesses and the production of books, papers, maps, or other materials. Failure to appear or to testify or to produce materials without adequate excuse may be reported by the commissioner to the appropriate circuit court for enforcement.

6. Judgment and final order. The commissioner may designate a hearing officer or subordinate to conduct the hearing as provided in § 2.2-4020 of the Code of Virginia, and to make written recommended findings of fact and conclusions of law. The final decision shall be reduced to writing and will contain the explicit findings of fact upon which the decision is based. A certified copy of the decision shall be delivered to the affected owner. Notice of a decision will be served upon the parties and become a part of the record. Service may be by personal service or certified mail, return receipt requested.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 2.8, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000; Volume 42, Issue 5, eff. November 19, 2025.

12VAC5-610-210 Request for hearing

The commissioner or any person or owner injured by alleged violation of this chapter may request a hearing of one of the types listed by sending the request in writing to the district or local health department. The request for hearing shall cite the reason or reasons for the hearing request and shall cite the section or sections of this chapter involved.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 2.9, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-220 Hearing as a matter of right

Any person or owner whose rights, duties, or privileges have been, or may be affected by any decision of the board or its subordinates in the administration of this chapter shall have a right to both informal and adjudicatory hearings. The commissioner may require participation in an informal hearing before granting the request for a full adjudicatory hearing.

Exception. No person other than an owner shall have the right to an adjudicatory hearing to challenge the issuance of either a construction permit or operation permit unless the person can demonstrate at an informal hearing that the minimum standards contained in these regulations have not been applied and that he will be injured in some manner by the issuance of the permit.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 2.10, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-230 Appeal

A. Any appeal from a denial of a construction permit for a sewage disposal system must be made in writing and received by the department within 30 days of the date of receipt of notice of the denial.

B. Any request for hearing on the denial of an application for a variance pursuant to 12VAC5-610-170 E 1 must be made in writing and received within 30 days of receipt of the denial notice.

C. Any request for a variance must be made in writing and received by the department prior to the denial of the sewage disposal system permit, or within 30 days after such denial.

D. In the event a person applies for a variance within the 30-day period provided by subsection C of this section, the date for appealing the denial of the permit, pursuant to subsection B of this section, shall commence from the date on which the department acts on the request for a variance.

E. Pursuant to the Administrative Process Act (§ 9-6.14:1 et seq. of the Code of Virginia), an aggrieved owner may appeal a final decision of the commissioner or Appeal Review Board to an appropriate circuit court.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 2.11, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-240 Permits; general

No person or owner shall construct, operate, expand or modify a sewage disposal or handling system without a written permit from the commissioner.

A. Sewage disposal permits. No person or owner shall cause or allow the construction, expansion or modification of a sewage disposal system without the written construction permit from the commissioner which authorizes the construction or modifications. Furthermore, no person or owner shall cause or permit any sewage disposal system constructed after the effective date of this chapter to be operated without a written operation permit issued by the commissioner which authorizes the operation of the sewage disposal system, and/or nonpublic drinking water system (see 12VAC5-610-340). Conditions may be imposed on the issuance of any permit and no sewage disposal system shall be constructed, modified or operated in violation of these conditions.

B. Sewage handling permits. Any person who removes or contracts to remove and transport by vehicle the contents of any septic tank, sewage treatment plant, privy, holding tank, portable toilet, or any sewage septage or sewage sludges from any other device shall be deemed an owner and shall have a written sewage handling permit issued by the commissioner.

Exception. No such permit is required for the handling of sewage from (1) a holding tank on a vehicle or vessel by the owner of such vehicle or vessel or (2) the removal of screenings, sludges, grit, etc. from a sewage treatment plant by the owner or employees of such sewage treatment facilities.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 2.12, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-250 Procedures for obtaining a construction permit for a sewage disposal system

Construction permits are issued by the commissioner but all requests for a sewage disposal construction permit shall be directed initially to the district or local health department. For construction permits with design flows less than 1,000 gallons per day that are exempt from the license requirements for professional engineers under § 54.1-402 A 11 of the Code of Virginia, the requirement for formal plans and specifications is waived.

A. Type I. A Type I sewage disposal system is an individual sewage disposal system incorporating a septic tank and subsurface soil absorption (septic tank-subsurface drainfield) serving a single residence. The submission of an application is all that is normally necessary to initiate procedure for obtaining a permit under this subsection. If after a site investigation, it is determined that pumping, enhanced flow distribution (see 12VAC5-610-930 A) or low pressure distribution (see 12VAC5-610-940) is necessary, the system shall be considered a Type II system.

B. Type II. A Type II sewage disposal system is a sewage disposal system incorporating a septic tank and subsurface soil absorption system which serves a commercial or other establishment, more than a single family dwelling unit, or where pumping, enhanced flow distribution (see 12VAC5-610-930 A) or low pressure distribution (see 12VAC5-610-940) is necessary. The procedure for obtaining a permit includes the following steps:

1. The submission of an application;

2. A preliminary conference as necessary; and

3. The submission of informal plans, specifications, design criteria, and other data, as may be required by the district or local health department. Depending on the size and complexity of the system, the submission of formal plans and specifications may be required.

C. Type III. A Type III sewage disposal system includes sewage disposal systems other than a septic tank subsurface soil absorption system, and subsurface soil absorption systems, regardless of design, with design flows greater than 1,000 gpd. The procedure for obtaining a permit under this subsection includes the following steps:

1. The submission of an application;

2. A preliminary conference; and

3. The submission of formal plans, specifications, and design criteria. Other supporting data may be required on a case-by-case basis.

When high strength wastes are proposed for subsurface disposal, the treatment methodology shall comply with the requirements found in 12VAC5-580-10 et seq. of the Sewage Regulations.

D. Type IV-Privies. The submission of an application is all that is normally necessary to initiate the procedure for obtaining a permit under this section.

E. Application. All applications for any type sewage disposal system shall be made on an application form provided by the district or local health department and approved by the department.

F. Preliminary conference. A preliminary conference with the district or local health department is held for Type II and Type III systems. When a Type III system for septage disposal is planned, the conference shall be with the department. At such conference the owner or his agent shall be prepared to set forth the sewage disposal problems and the proposed solution in such a manner to support his conclusions and recommendations.

G. Formal plans.

1. All formal plans for sewage disposal systems shall bear a suitable title showing the name of the owner and shall show the scale in feet, a graphical scale, the north point, date, and the name of the licensed professional engineer by or under whom prepared. The cover sheet and each plan sheet shall bear the same general title identifying the overall sewage disposal project and each shall be numbered. Appropriate subtitles should be included on the individual sheets.

The plans shall be clear and legible. They shall be drawn to a scale which will permit all necessary information to be plainly shown. The size of the plans should be no larger than 30 inches by 48 inches. Data used should be indicated. Location, when made, shall be shown on the plans. Logs of test borings shall be given either on plans or in the specifications.

Detailed plans shall consist of plan views, elevations, sections, and supplementary views that together with the specifications and general layouts provide the working information for the contract and construction of the work, including dimensions and relative elevations of structures, the location and outline form of equipment, the location and size of piping, water levels, ground elevations, and erosion control abatement facilities.

2. Geographical and other features. Topography, elevations (contour lines), existing or proposed streets and all bodies of water, ditches, buildings, springs, cisterns, and wells within 100 feet horizontally of the proposed sewage disposal system site and well, a water mounding analysis showing the impact of the proposed sewage system on ground water and all property lines shall be clearly shown.

3. General layout. The general layout shall show the following:

a. Test borings, ground water elevation (if observed), and soil profiles;

b. Size and location of sewage disposal systems;

c. Schematic flow diagram showing the flow through the various disposal system units;

d. Piping; and

e. Hydraulic profile showing the flow of sewage.

4. Detailed plans. Detailed plans shall show the following:

a. Location, dimensions, and elevations of existing or proposed system facilities;

b. Pertinent data concerning the rated capacity of pumps, blowers, motors, and other mechanical devices. All or part of such data may be included in the specifications by suitable reference on the plans;

c. Average and maximum hydraulic flow in profile; and

d. Adequate description of any features not otherwise covered by the specifications.

H. Formal specifications. Complete technical specifications for the construction of the sewage disposal system and all appurtenances shall accompany the plans. The specifications accompanying construction drawings shall include all construction information not shown on the drawings, which is necessary to inform the builder in detail of the design requirements as to the quality of material workmanship and fabrication of the project, type, size, strength, operating characteristics, and rating of equipment; allowable infiltration, machinery, valves, piping, and jointing of pipe, electrical apparatus, wiring and meters; operating tools and construction materials; special filter materials such as stone, sand, gravel, or slag; miscellaneous appurtenances; chemicals when used; instructions for testing materials and equipment as necessary to meet design standards and operating test for the complete works and component units.

I. Special requirements for certain sewage disposal systems. A construction permit for a single sewage disposal system proposed to serve a dwelling unit with multiple living units, multiple dwelling units or multiple lots with dwelling units shall be issued only to a single owner. The owner shall provide legal documentation to assure operation and the maintenance of the system for the expected life of the living units or dwellings.

J. Construction permit with conditions.

1. Definition: "Conditional construction permit" means a permit authorizing the installation of a septic tank subsurface soil absorption system which does not fully conform to the criteria in Part V (12VAC5-610-660 et seq.) of this chapter pertaining to septic tank size, subsurface soil absorption system size and certain ground water table conditions as indicated by soil evaluation, but which, under the conditions to which the permit is subject, can be reasonably expected to function without danger to public health.

2. The purpose of this section is to allow for the issuance of conditional construction permits. Procedures for obtaining a conditional construction permit are the same as those contained in subsections A, B, C, and D of this section.

3. Conditional construction permits may be issued for any one or more of the following use conditions when satisfactory substantiation is provided by the applicant:

a. Reduced water flow based on permanent water saving plumbing devices;

b. Limitations on the number of persons occupying the dwelling or using the facility served by the proposed septic tank system;

c. Intermittent or seasonal use of the dwelling or facility served by the septic tank system; and

d. Temporary use of the septic tank system for a specified time period not to exceed one year. Such permits may be renewable when the commissioner determines there is a good cause for renewal.

4. Criteria.

a. The septic tank or drainfield size may be reduced based on the use conditions contained in subdivision 3 a, b, c, or d of this subsection.

b. In areas with seasonal fluctuating water tables, where the seasonally high water table would cause failure if the system were to be used continuously, septic tank systems may be installed when the period of use of the septic tank system coincides with the period when the ground water table, as indicated by free water, is at its lowest level. Acceptable separation distances to free standing ground water are the same as those found in Tables 4.3 and 4.4 of this chapter.

c. Because of the increased risk of failure, a conditional permit shall not be issued, in an area with a seasonally fluctuating water table if the proposed absorption area is within 200 feet of a shellfish growing area, recreational waters, or a public water supply impoundment.

5. The district or local health department shall affix to the conditional construction permit a clear and concise statement relating the conditions and circumstances that formed the basis for issuing the conditional permit as well as the owner's obligations under the permit.

6. The holder of any conditional construction permit shall have the permit recorded and indexed in the grantor index under the holder's name in the land records of the clerk of the circuit court having jurisdiction over the site of the septic tank system. District or local health departments shall be provided with certification that the conditional septic tank system permit has been recorded in the land records of the circuit court. The conditional permit shall become effective one day after the district or local health department receives notification of recordation. The district or local health department shall advise the local building official that conditional septic tank system permits are not valid without certification that the permits have been properly recorded as required and shall forthwith notify the local building official when the conditional permit becomes effective. Final approval of the construction of the septic tank subsurface soil absorption system shall not be given until or unless the system is constructed in accordance with the conditions of the permit. The operation permit will be issued in accordance with 12VAC5-610-340.

7. As per § 32.1-164.1 of the Code of Virginia, the holder of the permit and any subsequent holders of the permit shall be bound by the conditions stated in the permit unless the holder or subsequent holder obtains an additional permit for modification or alteration of the septic tank system to meet any new use conditions.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 2.13, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000; Volume 39, Issue 4, eff. November 24, 2022.

12VAC5-610-255 Certification letters

A. An applicant for a sewage disposal system who does not intend to build within 18 months of application shall apply for a certification letter. The process shall be the same as for a system application made in accordance with 12VAC5-610-250. The fees charged for a certification letter shall be the same as prescribed in § 32.1-164 C of the Code of Virginia.

B. Certification letters indicate that a site is suitable for an onsite sewage treatment and disposal system and do not need to indicate the type of system for which the site is suitable.

C. Certification letters do not expire and shall convey with the land in the event the property is sold between the time the certification letter is issued and a construction permit is requested.

D. Certification letters may be converted to a construction permit by making application to the local health department in accordance with 12VAC5-610-250 and paying any required fees. Note, however, no additional fee shall be charged when a certification letter is converted to a construction permit within 18 months of the date the letter was issued.

E. Formal plans and specifications are not required in order to obtain a certification letter unless said plans and specifications are necessary to determine the appropriateness of a site for a sewage disposal system. Depending upon the type and complexity of the system to be permitted, formal plans and specifications may be required.

F. Certification letters shall be issued only for conventionally approved systems. Certification letters shall not be issued for experimental or provisionally approved systems because there is no assurance that said system will successfully complete the required testing and demonstration and, hence, may not be available when the property owner wishes to convert the letter to a construction permit. Further, no certification letter shall be issued for a conditional permit pursuant to 12VAC5-610-250 J.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-260 Requirements for the submission of formal plans, specifications and other data

A. In accordance with the provisions of Title 54.1 of the Code of Virginia, all formal drawings, specifications, reports, and other documents submitted for approval shall be prepared by or under the supervision of a licensed professional engineer. The front cover of each set of drawings, of each copy of data and each copy of the specifications submitted shall bear the original imprint of the seal and signature of the licensed professional engineer by or under whom prepared. In addition each drawing submitted shall bear an imprint or a legible facsimile of such seal.

B. If revisions to the formal plans, specifications or documents are necessitated, a letter will be sent to the engineer outlining the revisions and requesting submission of the revised documents within 30 calendar days.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 2.14, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-270 Approval of formal plans

Final, complete and detailed plans and specifications submitted in accordance with the provisions of 12VAC5-610-250 and 12VAC5-610-260 will be reviewed by the district or local health department as appropriate as soon as practicable upon receipt. Such plans will be approved if they demonstrate compliance with the criteria set forth in Part V (12VAC5-610-660 et seq.) of this chapter, and if the sewage disposal system will be able to function properly. A set of approved plans will be returned to the owner.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 2.15, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-280 Issuance of the construction permit

A. A construction permit shall be issued by the commissioner after approval of the application submitted under 12VAC5-610-250 A and D and fulfilling the requirement contained in 12VAC5-610-700 E 2, if applicable.

B. A construction permit shall be issued by the commissioner after approval of the application and plans and specifications submitted under 12VAC5-610-250 B and C. Such approvals shall include the requirement contained in 12VAC5-610-700 E 2, if applicable, and applicable requirements of the Department of Environmental Quality in accordance with § 32.1-164.3 of the Code of Virginia.

C. Exception.

1. If compliance with the criteria contained in Part IV (12VAC5-610-591 et seq.) or Part V (12VAC5-610-660 et seq.) of this chapter imposes economic or other conditions that are not justified by the health considerations upon which the criteria are based, a construction permit may be issued for the disposal system design which substantially complies with the criteria set forth in Part IV or V of this chapter.

2. When issuing a construction permit for repair of an existing failing sewage disposal system for an occupied structure with indoor plumbing, the criteria contained in Parts IV and V of this chapter shall be complied with to the greatest extent possible. However, it is not necessary to substantially comply with all of the requirements in those parts of this chapter with the exception of the set back distances for shellfish waters or drinking water wells, unless the system is already closer in which case the corrected system shall not be closer than the existing system. Furthermore, when it can be documented that compliance with those parts creates an economic hardship, the district health director or the district environmental health manager may waive the requirements for pretreating the effluent. All corrections must be of such a nature that they can reasonably be expected to reduce the risk to public health caused by the malfunctioning systems.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 2.16, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-290 Denial of a construction permit

A. If it is determined that the proposed design is inadequate or that soil, geological or other conditions are such to preclude safe and proper operation of a proposed sewage disposal system or that the installation of the system would create an actual or potential health hazard or nuisance, the permit shall be denied and the owner shall be notified in writing of the basis for the denial. The notification shall also state that the owner has the right to appeal the denial.

B. Construction permits may be denied for new construction to be served by a public water supply system which has reached its permitted capacity.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 2.17, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-300 Voidance, revalidation, and revocation of construction permits with and without conditions

A. Null and void. All sewage disposal construction permits are null and void when (i) conditions such as house location, sewage system location, sewerage system location, well location, topography, drainage ways, or other site conditions are changed from those shown on the application; (ii) conditions are changed from those shown on the construction permit; or (iii) more than 18 months elapse from the date the permit was issued. Reapplication for the purposes of having an expired permit reissued shall be the responsibility of the owner, and such reapplication shall be handled as an initial application and comply fully with 12VAC5-610-250.

B. Revalidation. Except as provided in 12VAC5-610-70, construction permits shall be revalidated if more than 18 months have elapsed since issuance of the construction permit and construction has not commenced. The district or local health department shall revalidate the permit if the permit had been previously issued in accordance with this chapter and the site conditions are the same as shown on the application and construction permit. Exception. This subsection is inapplicable to a Type III septage disposal facility.

C. Revocation. The commissioner may revoke a construction permit or inspection statement for any of the following reasons:

1. Failure to comply with the conditions of the permit;

2. Violation of any of this chapter for which no variance has been issued;

3. Facts become known which reveal that a potential health hazard would be created or that the ground water resources may be adversely affected by allowing the proposed sewage disposal system to be installed or completed.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 2.18, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-310 Revisions of approved plans

Any deviation from approved plans and specifications affecting capacity, hydraulic conditions, operating units or the functioning of the sewage disposal system must be approved by the bureau before such changes are made. Revised plans and specifications shall be submitted in time to permit the review and approval of such plans and specifications before any construction work which will be affected by the changes is begun.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 2.19, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-320 Inspection and correction

No part of any installation shall be covered with earth or used until inspected, corrections made if necessary, and approved, by the district or local health department or unless expressly authorized by the district or local health department. Any part of an installation which has been covered prior to approval shall be uncovered upon the direction of the district or local health department. This section shall not apply to any sewage disposal system installation that is pursuant to a design certified by a licensed professional engineer or onsite soil evaluator.

Exception. This section is inapplicable to a Type III septage disposal facility.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 2.20, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 29, Issue 4, eff. November 22, 2012.

12VAC5-610-330 Inspections of private evaluations and designs and reports required upon completion of construction

A. Upon completion of the construction or modifications of a sewage disposal system permitted pursuant to a design certified by a licensed professional engineer or onsite soil evaluator, the certifying licensed professional engineer or onsite soil evaluator shall inspect the sewage disposal system installation in a timely manner and submit to the district or local health department a signed inspection report stating that the installation was completed substantially in accordance with the approved evaluation and design revised only in accordance with the provisions of 12VAC5-610-310. This inspection report shall be based upon inspections of the sewage disposal system during and after construction or modifications that are adequate to assure the accuracy of the report. The department may, but is not required to, inspect the installation of such sewage disposal system. In the event that the certifying licensed professional engineer or onsite soil evaluator does not inspect the installation in a timely manner or declines to certify that the installation was completed substantially in accordance with the approved evaluation and design, the owner may petition the district or local health department to inspect the installation and render a final case decision approving or disapproving the installation. The district or local health department shall not be required to convene an informal fact-finding proceeding in accordance with § 2.2-4019 of the Code of Virginia or 12VAC5-610-200 prior to rendering such decision.

B. Statement from the sewage disposal system contractor. Upon completion of the construction or modification of a sewage disposal system, the owner shall submit to the district or local health department a statement signed by the contractor that the construction work was completed in accordance with the construction permit, and when appropriate the plans and specifications approved for the project and substantially in accordance with Part V (12VAC5-610-660 et seq.) of this chapter.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 2.21, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000; Volume 29, Issue 4, eff. November 22, 2012.

12VAC5-610-340 Issuance of the operation permit

Upon satisfactory completion of the requirements of 12VAC5-610-320 and 12VAC5-610-330 the commissioner shall issue an operation permit. The issuance of an operation permit does not denote or imply any guarantee by the department that the sewage disposal system will function for any specified period of time. It shall be the responsibility of the owner or any subsequent owner to maintain, repair or replace any sewage disposal system that ceases to operate as defined in the operation permit and in 12VAC5-610-350.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 2.22, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-350 Failure of a sewage disposal system

For the purpose of requiring correction of a malfunctioning sewage disposal system the presence of raw or partially treated sewage on the ground's surface or in adjacent ditches or waterways or exposure to insects, animals or humans is prima facie evidence of such system failure and is deemed a violation of these regulations. Pollution of the groundwater or backup of sewage into plumbing fixtures may also indicate system failure.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 2.23, eff. February 5, 1986; amended, Virignia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-360 Review of subdivision plats for individual sewage disposal systems when required by local ordinance

A. The intent of this section is to assure that adequate information is supplied to the district or local health department to determine if any or all proposed lots contain a suitable area and reserve area for onsite sewage disposal systems prior to recordation of the subdivision plat. This section shall not be construed to restrict the department in rendering preliminary opinions in accordance with local ordinances prior to recordation. The information requested herein is supplemental to the information which may be required by local subdivision ordinances.

B. A subdivision plat or a subsection of a subdivision plat submitted to the district or local health department for review of onsite sewage disposal systems shall show at a minimum the location of the proposed onsite sewage disposal systems and the reserve absorption areas if required by Part V (12VAC5-610-660 et seq.) of this chapter, 12VAC5-610-710 for the onsite sewage disposal systems and the location of the water supply system on each lot, if applicable. Each plat or subsection of a subdivision plat shall be accompanied by specific soil information for each lot (absorption area and reserve area) in accordance with Article 1 (12VAC5-610-450 et seq.) of Part III of this chapter. If not provided by the local subdivision ordinance, the district or local health department may require the plat to show streets, utilities, storm drainage, water supplies, easements, lot lines and original topographic contour lines by detail survey or other information as required. For suggested contour interval and scale see APPENDIX L.

C. No department employee shall sign or indicate approval for onsite sewage disposal systems on a subdivision plat or subsection of a subdivision plat for recordation until a sewage disposal site(s), including reserve area when required in accordance with 12VAC5-610-710, has been identified, approved or disapproved and recorded on each lot of the subdivision plat on file with the district or local health department. The plat on file with the district or local health department shall be reconciled with the plat to be recorded. The recorded plat shall reference the plat on file with the department. The signature of a department employee on a recorded subdivision plat or subsection of a subdivision plat does not imply or connote that any lot(s) identified as approved shall be issued a sewage disposal construction permit unless all conditions and circumstances, such as but not limited to landscaping, contained in the original approval exist at the time of application for a sewage disposal construction permit.

D. Before building construction begins on a lot within the subdivision, a valid individual sewage disposal construction permit shall be issued for that lot in accordance with 12VAC5-610-280.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 2.24, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-370 (Repealed.)

Historical Notes

Derived from VR355-34-02 § 2.25, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; repealed, Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-380 Procedures for obtaining a sewage handling permit

A. Sewage handling permits are issued by the commissioner. (See 12VAC5-610-240 B.) Applications for such permits shall be directed to the district or local health department. The procedure for obtaining sewage handling permits includes the following:

1. Application;

2. Conference;

3. Scheduling of equipment for initial inspection; and

4. Approval of disposal site or sites.

B. Application. An application for a sewage handling permit shall be made to the local or district health department on a form provided by the department.

C. Conference. A conference will be held with the district or local department for the purpose of discussing the methods and equipment utilized in the handling of sewage.

D. Initial equipment inspection. The owner shall make arrangements with the district or local health department at a suitable time for inspecting the sewage handling equipment.

E. Approval of disposal site or sites.

1. An approved sewerage system or treatment works is a system for which a certificate to operate has been issued jointly by the department and the Department of Environmental Quality or a system which has been issued a separate permit by the commissioner. When the applicant is not the owner of the approved sewerage system or treatment works, the applicant shall append a statement from the owner of the approved sewerage system or treatment works to the application stating that the applicant may discharge septage and/or sewage. The statement shall include the quantity per day and point of discharge as indicated on the application to the approved sewerage system or treatment works.

2. If the disposal site is not an approved sewerage system or treatment works, each disposal site shall be considered a special facility (see 12VAC5-610-590 B) and shall be inspected and approved or disapproved on a case-by-case basis by the district or local health department and the bureau in accordance with 12VAC5-610-250 C.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 2.26 eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-390 Issuance of sewage handling permit

The commissioner shall issue a sewage handling permit upon satisfactory completion of the procedures outlined in 12VAC5-610-380 and compliance with the criteria contained in Article 2 (12VAC5-610-560 et seq.) of Part III and Articles 8 (12VAC5-610-1020 et seq.) and 9 (12VAC5-610-1080 et seq.) of Part V of this chapter.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 2.27, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-400 Revocation of sewage handling permits

A. Each permit shall be for a time period not to exceed 12 months.

B. Each permit may be revoked when conditions are changed from those shown in the application.

C. Each permit may be revoked when there is a potential or real health hazard associated with the sewage handling operation.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 2.28, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-410 Special permits for pump and haul of sewage

A special permit for a definite time period issued by the commissioner is required for pump and haul. (See Part III, Article 2 of this chapter.)

Exception.

1. No such special permit is required for pump and haul associated with pumpout facilities at marinas or other places where boats are moored which are authorized by the Rules and Regulations Governing Sewerage and Sanitary Facilities at Marinas and Other Places Where Boats are Moored.

2. Where pump and haul is a maintenance requirement of an approved sewage disposal system such as pumping septage from a septic tank or periodic pumping of a holding privy, no such separate special permit is required.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 2.29, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-420 Procedure for obtaining a pump and haul permit

A. An owner who seeks a pump and haul permit shall follow the following steps:

1. Application;

2. Conference;

3. Plans, specifications, and other data as may be required;

4. Securing a contract with a sewage handling contractor having a valid sewage handling permit;

5. Submission of a detailed construction schedule for completion of the permanent receiving facilities; and

6. Bonding.

B. Application. An application shall be made through the district or local health department on a form provided by the department.

C. Conference. A conference is necessary with the district or local health department for the purpose of discussing the reasons for pump and haul and the methods and equipment to be utilized in the pump and haul operation.

D. Plans and specifications. Plans and specifications in sufficient detail shall be provided, when required, to show the sewage collection and holding facilities. See 12VAC5-610-250 C and E for further details relating to plans and specifications.

E. Contract with a sewage handling contractor. The owner shall secure and maintain a contract with a sewage handling contractor having a valid sewage handling permit. The contract shall be for a period of time sufficient to complete the construction necessary to alleviate the need for pump and haul.

The contract shall contain at a minimum, the following conditions:

1. Duration of contract;

2. Pumping schedule;

3. Availability of equipment;

4. Emergency response capability;

5. Disposal site, including limitations, utilized by the contractor; and

6. The contractor shall maintain and submit records on a monthly basis to the owner and the department. The records shall indicate the date, time and volume of each load, the disposal site or sites utilized and overflows or spillage.

F. Submission of detailed construction schedules. A detailed construction schedule shall show at a minimum, initial construction date and date of completion. Progress reports shall be submitted monthly.

G. Bonding. The commissioner may require any owner holding or applying for a permit issued pursuant to this section to post a bond with surety approved by the commissioner for the purpose of insuring continuation of the pump and haul operation for the specified time period contained in the pump and haul permit. Such bond shall be forfeited if the owner ceases to continue the pump and haul operation before the need for pump and haul has been alleviated. The forfeited bond shall be expended as necessary to restore and maintain the pump and haul operation for the permitted time period. Forfeiture of the bond shall not relieve the permit holder of any other legal obligations set forth in this chapter. No bond shall be required of a government entity holding a permit in accordance with 12VAC5-610-550.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 2.30, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-430 Issuance of a construction permit for storage facilities associated with the pump and haul of sewage

A construction permit shall be issued by the commissioner after completion of the requirements contained in 12VAC5-610-420 and, Article 7 (12VAC5-610-990 et seq.) of Part V of this chapter.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 2.31, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-440 Issuance of the special pump and haul permit

After concurrence of the local political subdivision and upon satisfactory completion of the requirements set forth in 12VAC5-610-420, 12VAC5-610-430, Article 4 (12VAC5-610-598 et seq.) of Part IV and Article 7 (12VAC5-610-990 et seq.) of Part V of this chapter, and if the commissioner determines that issuance of the pump and haul permit is in the best interest of public health, a permit shall be issued.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 2.32, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

Article 2 Systems with Experimental or Provisional Approval

12VAC5-610-441 Special permits for experimental methods, process and equipment

Article 2 Systems with Experimental or Provisional Approval

A. New construction. Sewage treatment and disposal methods, processes, and equipment which (i) are not covered by criteria in Part V (12VAC5-610-660 et seq.) of this chapter and (ii) in principle and/or application are new or unconventional are subject to a special permitting procedure in lieu of that set forth in 12VAC5-610-250. All applications for such processes, methods, and equipment shall be made to the division through the district or local health department.

1. Submission of data on experimental methods, processes, and equipment. The policy of the division is to encourage the development of any new methods, processes, and equipment which appear to have application for the treatment and disposal of sewage; however, new developments shall have been thoroughly tested in a full scale or representative pilot system utilizing this process and equipment. Results of this testing must be submitted to the division. The testing required on new developments will generally follow the following guidelines:

a. All procedures used in validating the process shall be conducted under the supervision of a faculty member in an appropriate program of an accredited college or university, a licensed professional engineer experienced in the field of sanitary engineering, or by a testing firm acceptable to the division.

b. The tests shall be performed under maximum design conditions and over extended periods of time in the geographical area of the proposed installation.

c. The data shall be from a continuous operation of a full scale or pilot installation treating or conveying the type of sewage to be handled.

d. Flow measuring equipment shall be provided and total flow shall be recorded daily.

e. The minimum sampling and analysis program will be established by the division in accordance with the process under investigation.

f. All analyses will be made in accordance with Standard Methods for the Examination of Water and Wastewater, 1992 (American Public Health Association), or analytical methods approved by the division.

g. The sampling shall establish the impact of the experimental sewage treatment and disposal methods, processes, or equipment on ground water and public health.

h. The application shall identify and suggest operation and maintenance guidelines for the process or components of the process.

2. Detailed plans must be submitted showing how, in case of noncompliance, the method, equipment or process will be converted to or replaced with a proven system. In order to assure that funds are available to convert or replace the experimental method, equipment or process with a proven system, bonding or other assurances shall be provided. A proven system shall be a Type I, II, or III system, a point source discharge system or connection to an existing approved sewerage system or treatment works. The application for the experimental system shall be accompanied by one of the following: (i) a Virginia Pollution Discharge Elimination System (VPDES) permit, or (ii) a General Permit Registration Statement issued by the Department of Environmental Quality and a construction permit for an alternative discharging sewage treatment system issued by the commissioner, or (iii) certification from the owner of the existing sewage system or treatment works that connection is available, or (iv) a valid construction permit for a Type I, II, or III system.

3. Issuance of a construction permit. After review of the plans and testing data by the division and approval of a proven system (see subdivision 2 of this subsection), the commissioner shall issue a construction permit in accordance with the procedures in 12VAC5-610-250 if reasonably satisfied that the method, process, or equipment will provide satisfactory sewage disposal.

4. Issuance of an experimental operation permit. Upon completion of construction or modification, a permit to operate for a definite period of time will be issued for the operation of the experimentally approved methods, processes and equipment. The number of experimental systems of similar design characteristics to be installed for an evaluation period shall be determined by the division and where soil dependent systems are utilized, the number shall be limited to not more than four for each physiographic province (see Appendix K). There shall be no limit on the number of experimental systems allowed to be installed when an approved back-up system is constructed in accordance with subdivision 2 of this subsection and plumbing is provided to the back-up system. In this instance, a flow diversion valve shall be installed to divert wastewater flow between the two systems as necessary. The experimental permit to operate the experimental system shall require that the evaluation period be a minimum of 18 months and no longer than 36 months, under design conditions, and the holder of the experimental operation permit shall submit reports on operation during the evaluation period as required by the division.

5. Issuance of an operation permit. The commissioner shall issue an operation permit upon expiration of the experimental permit if, on the basis of testing during that period, the division finds that the experimental method, processes or equipment provides satisfactory sewage disposal. If these conditions are not met, then the commissioner shall issue an order which will require the owner to alter the sewage disposal system in a manner that will enable the conditions to be met.

B. Existing construction. Sewage treatment and disposal methods, processes and equipment (i) are not covered by the criteria in Part V (12VAC5-610-660 et seq.) of this chapter and (ii) in principle and/or application are new or unconventional may be utilized where a conventional sewage disposal system serving an occupied dwelling has failed and it is not possible to provide an alternate sewage disposal system having a discharge to state waters. The procedures for obtaining a permit for such systems shall generally follow those set forth in subsection A of this section with the following exceptions:

1. The detailed plans required need not show how in case of nonacceptance the sewage disposal system will be converted to or replaced with a proven process nor are bonds or assurances required;

2. More than four permits for soil dependent experimental systems of similar design characteristics may be issued per physiographic province; and

3. If the disposal system fails to work satisfactorily on a year-round basis, further correction to the system may be required.

C. Issuance of design and construction criteria. When sewage treatment and disposal methods, processes or equipment have demonstrated satisfactory performance and operational competence to the satisfaction of the commissioner, by completing the experimental process or by similar rigorous testing in other states or countries, provisional system approval shall be granted and design and construction criteria shall be developed in accordance with this article. If the wastewater to be treated is substantially different in flow or characteristics from one which was used during testing, the commissioner shall require the issuance of an experimental operating permit and further testing conducted until operational competence is demonstrated. The criteria shall include, at a minimum, the siting criteria, design and construction standards, performance, monitoring and service requirements of the methods, processes and equipment.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-442 Provisionally approved systems; overview

A. Sewage treatment and disposal systems, methods, processes, technology and equipment that are not covered by criteria in Part V (12VAC5-610-660 et seq.) of this chapter and have not received general approval for use under the provisions of this chapter may be eligible for provisional approval. Depending upon the complexity of the system, method, process, technology or equipment, provisional approval may be granted requiring individual applications for either a Type II or Type III system, as described in 12VAC5-610-250. After the evaluation period described in 12VAC5-610-500, a provisionally approved system may be given general approval and be incorporated into this chapter.

B. The purpose of the provisional approval process is to use, evaluate, and develop criteria for the use of new and innovative technology. The evaluation process allows the department a realistic amount of time, under varied field conditions, to develop and refine siting, construction, operation and maintenance criteria applicable to conditions and uses occurring in Virginia. During this evaluation period, residents of the Commonwealth have the benefit of the systems and the department can review, evaluate, revise and refine all aspects of criteria related to the system.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-443 Applying for provisional approval

A. Applications for provisional approval shall be made in writing to the division and shall request provisional approval for a specific system, technology, method or process. The application shall comply with 12VAC5-610-250 regarding the submission of detailed plans and specifications.

B. The application shall include the following:

1. A description of the system's operation including the accepted scientific and engineering principles upon which the system technology, method or process is based.

2. A description of the site criteria required for successful operation of the system.

3. Design criteria for sizing the system to meet all relevant site conditions and waste flow characteristics.

4. Construction procedures for successfully installing a system.

5. Operation criteria and maintenance requirements for the successful use of the system over the life expectancy of the system.

6. Proposed performance standards that the system is expected to meet to determine the success or failure of the system.

7. Documentation giving factual evidence of the principles upon which the system is based demonstrating the capacity for satisfactory performance and operational competency for treating and disposing of effluent. Such evidence must include sufficient basic and applied research to demonstrate that experimental status should be waived. Provisional approval of a product is principally intended to provide a method of full-scale system demonstration; however, limited applied research may be required when in the exclusive opinion of the department, the information obtained from applied research is necessary to the evaluation and decision-making process. Systems, technologies, methods, or processes which have not demonstrated sufficient basic and applied research to support the principles or theory of operation shall be considered experimental.

8. Documentation of at least 50 comparable systems of identical design and capacity having been installed in Virginia or elsewhere. Only systems installed under similar soil and site conditions (if applicable) to the site and soil conditions for which approval is sought in Virginia shall be considered. Additionally, the wastewater flows, strength and other characteristics shall be documented and be similar in both the demonstration systems and the proposed use in the provisional application.

9. Data indicating that the 50 systems identified in subdivision 8 of this subsection have provided both treatment and disposal no worse than a conventional septic tank-drainfield system over a period of time not less than three years.

10. Test results and certifications must be conducted by an accredited college or university, the National Sanitation Foundation, entities accredited by the American National Standards Institute, or other testing groups that may be acceptable to the division as being impartial and competent in testing or evaluating wastewater treatment and disposal methods.

C. An application submitted according to this section and containing the information required by subsections A and B of this section shall be considered a completed application.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-444 Evaluation process for provisional system applications

A. Preliminary evaluation. Upon receiving an application, the division shall review it for completeness. The division shall request additional information from the applicant if the application does not contain all of the requested information. Once the application is complete, the division shall prepare a summary and a preliminary evaluation of the proposal.

B. Division evaluation and recommendation. The division shall evaluate all completed applications and make a recommendation to the commissioner concerning the application. The recommendation, if favorable, shall include proposed criteria for installing, operating and maintaining the system. The division shall consider the following information which shall be provided by the manufacturer or other interested party:

1. Whether the demonstrations and test results required by 12VAC5-610-443 B will provide sufficient scientific evidence to support the proposed theory of operation and that the application of the theory is appropriate for proposed uses without posing an undue risk to public health and ground water.

2. The impact of the system on ground water and public health.

3. The operation of the system in other states. The division may solicit evaluations and comments from health officials in other states or countries where the system, method, process, equipment or technology has been used.

4. A review of the appropriate manufacturer's or the distributor's records relating to system maintenance and user complaints. Failure to maintain accurate and up-to-date records of maintenance actions and customer complaints may delay or prevent completing a review.

5. A review of any sample results which may be collected from or around any of the systems.

6. The practicability of preventative maintenance and the frequency of the required maintenance.

7. Other information as deemed appropriate by the division which relates to evaluating the effect of the system, method or process on ground water or public health.

C. Decision by commissioner. In making a decision, the commissioner shall review the recommendations of the division and the comments and recommendations made by the advisory committee. The commissioner may elect to approve or deny the application, or approve the application with conditions or with requirements for additional testing. The commissioner's provisional approval shall set forth the criteria for filing an application (i.e., Type II or Type III system), installing, operating, maintaining and testing the provisionally approved system. The commissioner's approval shall indicate that the provisional approval may be modified as set forth in 12VAC5-610-447 C.

D. During the first year of provisional system approval, a maximum of 100 permits may be issued for a provisionally approved system. When 50 or more systems have been installed, operated, reviewed by the division and found to be demonstrating satisfactory performance and operational competency, the division may allow additional permits to be issued, up to 1,000 systems during the first five years. No single increment of additional permits may exceed 500 additional systems and a satisfactory review must be made by the division prior to any additional release of permits. Further, at least 12 months must elapse between permit releases to assure adequate time passes for potential problems to develop and be discovered by the division.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-445 Appeals

A. Denial of provisional status. Pursuant to the Administrative Process Act (§ 9-6.14:1 et seq. of the Code of Virginia), any aggrieved applicant seeking provisional approval for a specific type of system may appeal the final case decision of the commissioner by requesting an adjudicatory hearing.

B. Denial of an applicant for use of a provisionally approved system. Aggrieved applicants who have been denied use of a system having provisional approval may request a hearing in accordance with 12VAC5-610-210.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-446 Permits for constructing and operating provisionally approved systems

A. Construction permit application. Homeowners can apply for a construction permit to install a provisionally approved system in the same manner provided for in 12VAC5-610-250 for Type II or Type III systems depending upon the nature of the provisional approval granted by the commissioner. Appeals from the denial of a permit application for a provisionally approved system shall conform to the requirements of 12VAC5-610-210.

B. Operation permit status. Homeowners installing a provisionally approved system in accordance with the construction permit issued by the commissioner and provisional siting, design and construction criteria for that system shall be issued an operation permit. Such operation permit shall be valid until the system ceases to operate in a safe and sanitary manner, as determined by the department. The validity of any individual operation permit issued for a system having provisional approval shall not be dependent upon ultimate approval or denial of that specific type of provisionally approved system for general approval under this chapter.

C. Recordation. All permits for provisionally approved systems shall be recorded with the clerk of the circuit court in the jurisdiction where the system is permitted, in accordance with 12VAC5-610-250 J 6.

D. Repair area. A 100% repair area, meeting or exceeding the requirements of this chapter, or an approved discharge permit shall be identified prior to permitting a site for a provisional system. The repair area shall be reserved for the exclusive use of the repair system. A 100% repair area meeting the requirements of the provisional approval shall be considered adequate toward meeting this repair area provision.

E. Maintenance. Whenever deemed appropriate by the commissioner, the department shall require operation and maintenance procedures and schedules appropriate for the method proposed.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-447 Evaluation period for provisionally approved systems

A. Evaluation criteria. Prior to receiving general approval and being incorporated into this chapter, systems with provisional approval shall be evaluated for not less than five years. The division should conduct an annual review of systems with provisional approval. The review, at a minimum, should be based on the following information submitted by the manufacturer; however, nothing shall prevent the department from verifying, augmenting or otherwise collecting additional information on the performance and operation of the system.

1. A field review of a sample of the systems installed. The sample shall include a representation of systems of newer and older installations and systems installed under different site and system limitations. System limitations will frequently be unique to each system and therefore the criteria used to select systems of different manufacturers will vary according to the nature and design of the system. The division shall determine the sample size to be evaluated and the criteria for sample selection.

2. Interviews with a sample of system owners to determine customer satisfaction and customer opinions. This sample may or may not be the same as the sample of systems reviewed under subdivision 1 of this subsection.

3. A review of the manufacturer's or the distributor's records relating to system maintenance and customer complaints. Failure to maintain accurate and up-to-date records of maintenance actions and customer complaints may delay or prevent completing a product review.

4. A review of any sample results which may be collected from or around any of the systems.

5. Other information as deemed appropriate by the division which relates to evaluating the effect of the system, method or process on ground water or public health.

B. Tracking of site locations. The manufacturer shall submit to the department records on the numbers, locations and operation of all provisionally approved systems on a quarterly basis not later than the 15th day of the month following the quarter.

C. Revisions to provisional approval. During the period of provisional approval, the department may revise any aspect of the site, soil and design requirements for that system based on experience gained during the use of the systems. The department shall work with the applicant to revise the approval by agreement, but shall not be prohibited from doing so without the consent of the applicant if warranted by health or environmental concerns. The revised provisional approval shall apply to any systems for which an application is filed after the revision is made.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-448 General approval of provisionally approved systems

A. After the evaluation period specified in 12VAC5-610-447 is completed, site selection design and construction criteria shall be developed when the commissioner is satisfied that the sewage treatment and disposal system, method, process or equipment has demonstrated operational competency and satisfactory performance equal to or better than that of a gravity flow septic tank drainfield absorption system. Initially these criteria shall be implemented by policy and shall grant the status of general approval to the system or process and shall not limit the number of systems allowed. Subsequently, at the discretion of the department, criteria for the approved system shall be incorporated into this chapter in accordance with the Virginia Administrative Process Act (§ 9-6.14:1 et seq. of the Code of Virginia). The criteria shall include, at a minimum, the site conditions necessary for permitting a system, design considerations, installation criteria, performance, monitoring and service requirements of the methods, processes and equipment.

B. After the evaluation period specified in 12VAC5-610-447 is completed, site selection and design and construction criteria required in Part V (12VAC5-610-660 et seq.) of this chapter shall not be developed if the commissioner concludes that the sewage treatment and disposal system, method, process or equipment has not demonstrated satisfactory performance and operational competency equal to or better than that of a gravity flow septic tank-drainfield absorption system. The provisional system approval may be extended or rescinded for any system failing to show equivalency with a gravity flow septic tank-drainfield absorption system. After the provisional approval for a system has been rescinded, any future applications for systems utilizing the same design shall be denied. However, this provision shall not be used to prevent systems of similar design which have been modified in a manner which can reasonably be expected to overcome the previously identified deficiencies to be considered under the experimental requirements of this chapter.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

Article 1 Evaluation Criteria for Subsurface Soil Absorption Systems

12VAC5-610-450 General

Soil evaluation for a subsurface soil absorption system shall follow a systematic approach including consideration of physiographic province, topography, available area, degree of slope, and soil profile (thickness of each horizon, color, permeability, and texture). The evaluation is intended to document sufficient information to conclude whether or not the site can accommodate an onsite sewage treatment and dispersal system listed in Part IV (12VAC5-610-591 et seq.) of this chapter. The topography, available area, seasonal water table, drinking water supplies, bodies of water, shellfish growing areas, soil horizon, depth, rate of absorption, or combination of any of the above shall be considered in such evaluation. A percolation test may be required as a prerequisite to the issuance of a permit. When the district or local health department questions the estimated percolation rate, the district or local health department may require a percolation test. Percolation tests shall be analyzed as only one of many criteria in determining soil suitability for absorption of treated sewage.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 3.1, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-460 Site and structure identification

A site plan (sketch) showing dimensions of property, proposed and/or existing structure or structures, driveways, underground and overhead utilities on the property and adjacent sewage disposal systems, bodies of water, drainage ways, agricultural drain tile, wells, cisterns, and springs for a minimum of 200 feet radius of the center of the proposed building or drainfield is necessary in order to evaluate the suitability of a subsurface soil absorption system for that site. In addition, for new construction, the boundary of the lot and building site shall be staked. As a minimum, prior to issuance of the construction permit the perimeter of the soil absorption area site or sites shall be shown on a copy of a surveyed plat of the property. When a parcel of land consisting of a single lot is involved on which an onsite sewage disposal system is proposed to be located and is not directly influenced by the off site location of any sewage disposal system, well, body of water, etc., the requirement for the surveyed plat may be waived by the district or local health department.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 3.2, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-470 Physical features

A. Physical features including soil features, slope, depth of rock, the location of rock outcrops, drainage ways, marshes, swamps, sink holes, flood plains, artificial drainage systems, and various structures and topographic features found in Tables 4.1 through 4.4 shall be fully and accurately documented in writing as part of the site and soil evaluation.

B. Drainage way. A drainage way is a concave portion of the landscape in which surface water or rain water run-off gathers intermittently to flow to a lower elevation.

C. Fill material. Fill material means soil transported and deposited by man as well as soil recently transported and deposited by natural erosion forces. Recent natural soil transportation and deposit is evidenced by one or more of the following.

1. No or indistinct soil horizons;

2. Depositional stratification;

3. Presence of a buried organic layer; and

4. Position in the landscape.

D. Minimum depth to seasonal water table. As used herein, "seasonal water table" means that portion of the soil profile where a color change has occurred in the soil as a result of saturated soil conditions or where soil concretions have formed. Typical colors are gray mottlings, solid gray or black. The depth in the soil at which these conditions first occur is termed "seasonal water table."

E. Artificial drainage. Where soils are artificially drained, soil coloration may no longer be an accurate indicator of the position of the seasonal water table. Three types of artificial drainage systems which are generally considered are as follows:

1. A water table depressor system of buried conduits, i.e., agricultural drainage tile;

2. A lateral ground water movement interceptor is a buried conduit for the purpose of intercepting lateral ground water movement, i.e., a French drain; and

3. Open ditches with the bottom elevation of the ditch below the seasonal water table.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 3.3, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-480 Soil profiles and patterns

A. General. The purpose of determining the soil profiles and patterns is to identify the soil characteristics that affect installation of a subsurface soil absorption system.

B. Soil profile. A soil profile is a vertical section of the soil throughout all its horizons.

C. Profile holes.

1. Acceptable equipment.

a. Auger. An auger is defined as a mechanical device which is used to remove a soil sample for evaluation. Devices utilizing the Archimedes screw principle are prohibited because they blend and mast the true soil characteristics.

b. Other equipment. Other equipment may be used in addition to an auger to expose the soil profile as long as it does not mask or blend the true soil characteristics.

2. General location of profile holes. Profile holes to determine design requirements shall be located in the area that is unrestricted by the criteria contained in Part IV (12VAC5-610-591 et seq.) of this chapter and Table 4.2. Additional profile holes outside the unrestricted area may be required to make a complete evaluation of the site.

3. Depth of profile hole. The minimum depth of the profile hole shall be five feet unless prevented or made unnecessary by some physical feature of the soil such as gray coloration, rock or when a potential horizon is found at a lesser depth. Where a potential soil horizon is considered for use, the soil evaluation shall be extended below the potential horizon to assure that there is no interference with seasonal water table, rock or impervious strata (See Tables 4.3 and 4.4 of this chapter).

4. Number and location of profile holes. A minimum of five holes is necessary to determine the design requirements of an area for the placement of absorption trenches. Where there is uniform topography and the profile holes exhibit a uniform profile, a minimum of three holes is necessary. The size of the area investigated shall be based on the soil texture group encountered. As a minimum, holes shall be placed to be representative of the area under consideration for placement of the absorption trenches.

If more than one area is required in which to install the absorption trenches, each area shall be evaluated as described above. If any proposed absorption trench site is found unacceptable due to soil conditions, the site shall have been evaluated with a minimum of three holes which characterize the soil problem or problems and support the reasons for rejection. The actual area and number of holes to be investigated may be more than described above and shall be determined on a case-by-case basis.

5. In situations where a large area is to be evaluated, where the soil is highly variable, where the profile must be exposed below five feet or where the soil is "tight" (dense or compact) and/or rocky, the district or local health department may require that the owner have the soil profile in selected areas exposed by the digging of trenches, auger holes or pits. The actual area and number of holes to be investigated shall be determined on a case-by-case basis.

D. Soil profile documentation. Soil profiles shall be determined and a record made in writing of each boring. Additional documentation may be required by the district or local health department.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 3.4, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-490 Characteristics of soils that determine suitability

A. Color. Color is a key indication of the suitability of a soil.

1. Red and yellow mottlings may indicate slow internal drainage and may indicate a seasonal water table.

2. Gray and/or gray mottlings indicate seasonal water tables for at least three weeks duration.

3. Black appearance may be due to organic matter which has accumulated due to poor soil drainage.

B. Texture. The term texture refers to the relative proportion of various size groups of individual soil grains in a mass of soil. Specifically it refers to the proportion of sand, silt, and clay.

1. Soil Classification. For the purpose of this chapter soils have been categorized into four groups based on texture as follows:

a. Texture Group I—sand and loamy sand;

b. Texture Group II—sandy loam, loam, and sandy clay loam. Texture Group II soils are subdivided into Texture Group IIa and IIb soils. Texture Group IIa soils consist of sandy loam soils with percolation rates less than 31 minutes per inch and no structure development. The remainder of soils within this texture group are Texture Group IIb soils;

c. Texture Group III—silt loam, clay loam, silty clay loam; and

d. Texture Group IV—sand clay, silty clay and clay.

2. The soil texture shall be estimated by field testing. The field test that shall be applied is contained in APPENDIX F and is entitled "Field Guide to Soil Texture Classes." Laboratory estimation of texture by sieve and sedimentation analysis may be substituted for the field test at the owner's request and expense. Samples shall be collected by the laboratory under supervision of the district or local health department.

C. Permeability. The term permeability pertains to the characteristics of the soil that enable water or air to move through its pores. The permeability of a soil profile may be limited by the presence of one nearly impermeable horizon, even though the others are permeable.

1. Estimated rates. The soil classifications contained in subdivision B 1 of this section have been assigned the following estimated rates in minutes per inch for the purpose of design. These rates may be modified when experience has shown that because of soil structure the texture group has a demonstrated rate different from that assigned.

a. Texture Group I—up to 16;

b. Texture Group IIa—17 to 30;

c. Texture Group IIb—31 to 45;

d. Texture Group III—46 to 90; and

e. Texture Group IV—equal to or greater than 91.

2. Percolation tests. When the estimated percolation rates are in question, percolation tests may be performed, however, the district or local health department may require percolation tests to determine "measured" percolation rates.

a. Requirements. Percolation tests are to be performed under the supervision of the district or local health department. Test holes shall be located at points and depths selected and/or approved by the district or local health department. A minimum of three holes representative of the absorption area are required. When the results of the individual test holes have a spread of more than 30 minutes/inch, five holes with at least one hole in the center of the proposed absorption area are required. Records of all percolation tests performed shall be attached to the application (See APPENDIX G).

b. Procedure. All percolation tests shall be performed in accordance with the procedure contained in APPENDIX G.

c. Records. Data on swelling, saturation and measurement of the percolation rate shall be recorded on forms by the district or local health department; examples of these forms are contained in APPENDIX G.

d. Interpretation of percolation test results. The absorption area shall be based on the average percolation rate measured in the test holes. The average percolation rate shall be computed by determining the percolation rate (minutes/inch) for each hole and averaging those values. When the percolation rate for an individual hole is in excess of 240 minutes/inch, the area represented may be retested one time and the most favorable rate used to calculate the percolation rate.

D. Soil restrictions. A soil restriction is a feature in the soil that impedes the percolation of water. Restrictions generally consist of a layer of soil horizon within a soil that is firmly compacted or is very rich in clay. Soils containing restrictions may require verification of the percolation rate by percolation tests. Examples of restrictions are listed below.

1. Pans. The term pans include hard pans, fragipans, clay pans, plowpans, traffic pans, iron pans, and plinthic horizons.

2. Stoniness. The term stoniness pertains to the relative proportions of stones present in a soil. Stoniness reduces the soil volume for absorption, and therefore, may require a larger subsurface soil absorption field than would be indicated by soil texture.

E. Soil concretions. Soil concretions as hard grains, pellets, or nodules from concentrations of compounds in the soil that cement the soil grains together. Concretions are indicative of slow percolation rates, restrictions, and/or seasonal water tables.

F. Shrink-swell soils. Shrink-swell soils may exhibit satisfactory percolation rates when dry and therefore must be thoroughly wetted before a percolation test is performed.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 3.5, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-500 Availability of suitable soils

Sufficient suitable soils shall be available to install the subsurface soil absorption system and reserve area. Design criteria for subsurface soil absorption systems are contained in Article 5 (12VAC5-610-900 et seq.) of Part V of this chapter and reserve area requirements are contained in 12VAC5-610-710.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 3.6, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-510 (Repealed.)

Historical Notes

Derived from VR355-34-02 §§ 3.7 to 3.11, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; repealed, Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-560 Sewage handling; general

A. In accordance with 12VAC5-610-240 B, a sewage handler shall have a written sewage handling permit issued by the commissioner.

B. It is the obligation of every sewage handler to assure that the sewage, sludge or septage handled are transported and disposed of in a safe and sanitary manner in conformance with this chapter. Treatment and management of sewage and sewage sludge are regulated by the Sewage Regulations (12VAC5-580-10 et seq.).

C. All sewage handling equipment in contact with sewage shall be washed in such a manner and location that the wastewater from washing it is conveyed to an approved sewerage system or treatment works.

D. Disposal of sewage sludges or septage into bodies of water or streams is prohibited.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 3.12, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-570 (Repealed.)

Historical Notes

Derived from VR355-34-02 § 3.13, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; repealed, Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-580 Septage management; general

Ultimate management of septage generally falls into one of two categories, landfilling or land spreading. Landfilling requires that the septage be stabilized and dewatered to increase solids content nearly fivefold to avoid leaching problems. Land spreading of both stabilized and unstabilized septage is permissible under controlled conditions for agricultural purposes. The preferred methods for septage disposal are disposal in an approved sewage treatment plant or stabilization and subsequent disposal by land application or landfilling in accordance with the Biosolids Use Regulations (12VAC5-585-10 et seq.).

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 3.14, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-590 Acceptable disposal sites

A. Sewerage system or treatment works. Any sewerage system or treatment works for which a certificate to operate has been issued jointly by the department and State Water Control Board or a system which has been issued a separate permit by the commissioner is considered an approved disposal site for vehicular transported sewage sludge or septage provided permission is obtained from the owner of the sewerage system or treatment works and the department and the State Water Control Board, as applicable, determine that the disposal of the sewage sludge or septage will not overload the facility.

B. Special facility. A special facility is a treatment works especially designed and constructed for the stabilization or disposal of septage including land as well as physical works. All special facilities are Type III sewage disposal systems (see 12VAC5-610-250 C). Industrial waste sludges and sludges containing chemical concentrations in violation of state hazardous waste regulations and applicable federal regulations shall not be placed in a special facility.

Exception: Special facilities related to lime stabilization or direct injection may not require formal plans and specifications to be submitted.

C. Processes which may be utilized in special facilities designed for stabilization of septage.

1. The following processes are described with associated criteria in the Commonwealth of Virginia Sewerage Regulations, State Department of Health, State Water Control Board, February 1977 (Sewerage Regulations, 12VAC5-580-10 et seq.):

a. Aerobic digestion;

b. Anaerobic digestion;

c. Chemical oxidation; and

d. Incineration.

2. The following processes are described in Article 9 of this chapter:

a. Anaerobic lagooning; and

b. Lime stabilization.

3. Other processes may be considered on a case-by-case basis if supported by operating and test data satisfactory to the department.

D. Land as a special facility for ultimate disposal of septage.

1. Landfilling. Prior to landfilling, septage must be stabilized and dewatered. All landfilling operations utilizing septage must be in conformance with the regulations of the Commonwealth of Virginia Department of Waste Management governing disposal of solid waste.

2. Land spreading. For the purpose of this chapter land spreading is the controlled uniform application of either dewatered or undewatered septage to the land surface for ultimate disposal. Land spreading shall be accomplished in such a manner so as not to adversely affect future agricultural use of the land. All land spreading operations must take into consideration such factors as application rates, potential runoff of contaminants from the septage applied to soils, groundwater contamination, proximity to residences and people and other public health considerations. All land spreading operations require site specific management criteria and approval.

a. Stabilized septage may be disposed of by land spreading in accordance with the provisions of applicable portions of 12VAC5-580-720 of the Sewerage Regulations and any applicable federal regulations, except where stated in this chapter.

b. Unstabilized septage may be disposed of by land spreading in accordance with the provisions of subsection E, the Code of Virginia and any applicable federal regulations.

E. Land spreading of unstabilized septage. General. Land spreading of unstabilized septage via shallow injection plowing is permissible (see 12VAC5-610-560 D). Injection plowing is a technique which employs a device which injects septage into a cavity created below the ground surface with positive closure of the injection swath. Injection plowing shall be accomplished with a narrow shank injector at a depth between 6 and 12 inches. The injection device and any associated prime mover shall be equipped with high flotation tires so as not to damage the physical characteristics of the soil in relation to agricultural practices. All land spreading operations for unstabilized septage shall provide for:

1. Storage during periods when weather, soil conditions or cropping conditions do not allow for injection;

2. Sampling and monitoring of the septage before land spreading for quality control as may be requested;

3. Record keeping and reporting for quality control;

4. Controlled access to the public for 12 months;

5. No grazing for at least one month following the date of each injection by farm animals whose products are consumed by humans;

6. Compliance with applicable portions of 12VAC5-580-720 of the Sewerage Regulations except where stated in this chapter; and

7. Limiting the application rate so as not to exceed ½ acre-inches (13,600 gal./acre) at one time due to the low solids content and excessive hydraulic loading by septage.

F. Special facility operation.

1. Records and reports shall be kept in a manner satisfactory to the department. As a minimum, the records shall reflect the quantity of septage (gallons) discharged into the special facility daily, the quantity (gallons) removed daily for land application, the land application site, and for anaerobic lagoons, the date the last load was discharged into the anaerobic lagoon. Reports shall be submitted to the department on a quarterly basis (See APPENDIX H).

2. Sampling and analyses requirements for special facilities are as follows:

a. Anaerobic lagoon. In accordance with the provisions of 12VAC5-580-720 of the Sewerage Regulations.

b. Lime stabilization of domestic septage. The origin and the pH of each load must be determined and recorded by the hauler prior to land application. However, periodic sampling and analyses may be required by the department on a case-by-case basis (See paragraph F 1 of this section).

c. Shallow injection of unstabilized septage. Generally no sampling and analyses will be required by the department. The origin of each load must be determined and recorded by the hauler prior to injection. However, periodic sampling and analyses may be required by the department on a case by case basis.

3. An operations and maintenance manual shall be prepared for the septage stabilization facility and shall contain, as a minimum the following information:

a. Site security methods to prevent unauthorized entry.

b. Procedures to maintain the appropriate records.

c. Site management procedures including all-weather access road and ground maintenance.

d. Methods and equipment utilized for placing septage into and removing septage from, the lagoon facility, mixing facility or storage facility as applicable.

e. Plan for land application of septage and/or other disposal methods.

f. Methods for odor control which may include both physical methods such as lagoon depth control and the use of appropriate chemicals.

g. Methods and procedures for monitoring characteristics of the septage and groundwater quality.

4. The site and physical works shall be maintained in a condition free from tall grass and weed overgrowth and rodent harborage.

5. When an anaerobic lagoon is utilized for stabilization its contents shall not be removed for land application until a time period of at least 90 days has elapsed from the time the last load of septage has been discharged into the lagoon.

G. Special facility abandonment. In the event a septage stabilization facility ceases to operate, it shall be the responsibility of the owner to abandon the facility properly. The following steps are required.

1. The owner shall notify the department at least 30 days in advance that the facility is to be abandoned;

2. The contents of the facility shall be disposed of in an approved manner under the supervision of the department; and

3. The structure shall be dismantled and the site returned approximately to its natural contours.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 3.15, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

Article 1 Site Limitations

12VAC5-610-591 Overview

The intent of this part is to provide guidance on how to match various treatment and dispersal systems to site-specific conditions in order to construct a safe, proper, and adequate sewage system for the site under consideration. Article 1 (12VAC5-610-591 et seq.) identifies site conditions which limit or prohibit the use of onsite systems. Article 2 (12VAC5-610-594 et seq.) establishes criteria for the use of systems that rely on naturally occurring undisturbed soils to treat and disperse effluent, with or without pretreatment. Article 3 (12VAC5-610-597 et seq.) establishes criteria for the use of systems which rely on fill soils to accomplish treatment prior to dispersal.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-592 Setback distances

A. Septic tanks, other tanks, and header line setback distances. The minimum separation distances between septic tanks, pump chambers, aerobic pretreatment devices (including sand filters, biofilters, and aerobic treatment units), header lines, and similar devices as determined by the department, and various structures and topographic features are contained in Table 4.1 entitled Minimum Separation Distances for Pretreatment Units, Conveyance Lines, and Header Lines.

B. Manifolds. Manifolds shall not pass closer than 50 feet to any drinking water source unless pressure tested in place at pump shut-off head. Under no circumstances shall a manifold come within 10 feet of a drinking water source.

C. Absorption area. The absorption area is the soil medium beginning at the interface between the soil and the gravel, sand, or other point of effluent application, which is utilized for dispersal of the effluent. The absorption area includes the infiltrative surface in the absorption trench, or the point of effluent application, and the soil between and around the effluent distribution system. Setback distance to various structures and topographic features and an absorption area are contained in Table 4.2.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-593 Physical features

Physical features, landscape position and soil characteristics affect the ability of soil-based systems to treat and disperse effluent. In order to correctly select and place a sewage system in the environment such that public health and the environment are protected, it is necessary to understand and consider the local hydrologic conditions, the regional geology, and the nature of the soils occurring on the site being evaluated. At a minimum, the following features shall be considered:

1. Marshes and swamps. Placement of subsurface soil absorption systems on or in swamps and marshes is prohibited.

2. Seasonal water table. A vertical separation distance between the point of effluent application and a seasonal water table shall be maintained which reflects the quality of the effluent and the receiving environment. Minimum vertical separation distances may be found in Articles 2 (12VAC5-610-594 et seq.) and 3 (12VAC5-610-597 et seq.) of this part and Tables 4.3 and 4.4.

3. Slope. Subsurface soil absorption trench systems shall not be placed on slopes greater than 50% unless terraced. Criteria for other types of onsite systems are contained in Tables 4.3 and 4.4.

4. Drainage ways. Subsurface soil absorption systems shall not be placed at a position in a drainage way subject to intermittent flooding.

5. Fill material. Placement of subsurface soil absorption systems in fill materials is generally prohibited except in three specific situations. The Wisconsin Mound system is considered a fill system as is the sand-on-sand system. These systems are governed by criteria found in 12VAC5-610-960, 12VAC5-610-965, and Table 4.4. Fill material consisting of colluvial soil derived from sandstone (noncarbonaceous) in the mountainous area may be considered on a case-by-case basis for placement of subsurface soil absorption systems.

6. Sink holes. Placement of a subsurface soil absorption system at the low point of a sink hole is prohibited. For set back distance see Table 4.2.

7. Flood plains. Subsurface soil absorption systems shall not be placed in flood plains subject to annual or more frequent sustained (24 hours) flooding.

8. Alluvial and colluvial deposits. Placement of subsurface soil absorption areas in alluvial and colluvial deposits with shallow depths, extended periods of saturation, or possible flooding is prohibited.

9. Shrink-swell soils. When soils containing horizons with shrink-swell characteristics (see definitions in 12VAC5-610-120) have been identified, they shall be rejected for use for subsurface soil absorption systems.

10. Soil restrictions. Soil restrictions in themselves may form the basis for outright rejection of the site.

11. Free standing water. The presence of free standing water in a profile hole may be grounds for rejection of the site.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

Article 2 Systems Using Naturally Occurring Undisturbed Soil

12VAC5-610-594 In-ground systems

A. An in-ground system is a system which utilizes a natural, undisturbed soil horizon to treat and disperse effluent where the infiltrative surface is placed 18 inches or more beneath the original surface of the ground. In-ground systems include, but are not limited to, conventional septic tank drainfield systems, chamber systems, alternative aggregate systems, enhanced flow systems, and pressure dosed systems.

B. Septic tank effluent. Septic tank effluent may be utilized in an in-ground system when all of the site and soil criteria of this subsection are met. Also see Table 4.3.

1. Horizon. The soil horizon(s) for the 18 inches immediately below the installation depth shall not show the presence of any limiting factor. Limiting factors include bedrock, seasonal or permanent water table, pans, or other impervious strata.

2. Separation distances. Table 4.2 contains the minimum setback distances between an absorption field and various structures or topographic features.

3. Estimated or measured infiltration rates. The estimated or measured infiltration rate shall not exceed 120 minutes per inch within any part of the sidewall area of the trench or within 18 inches of the infiltrative interface where effluent encounters undisturbed soil.

C. Soil criteria when utilizing secondary effluent. Secondary effluent may be utilized in an in-ground system when all of the criteria of this subsection are met. Also see Table 4.3.

1. Horizon. The soil horizon(s) for the 12 inches immediately below the installation depth shall not show the presence of any limiting factor. Limiting factors include bedrock, seasonal or permanent water table, pans or other impervious strata.

2. Separation distances. Table 4.2 contains the minimum setback distances between an absorption field and various structures or topographic features.

3. Estimated or measured infiltration rates. The estimated or measured infiltration rate shall not exceed 120 minutes per inch within the sidewall area of the trench, if any, or within 12 inches of the infiltrative interface where effluent encounters undisturbed soil.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-596 Shallow-placed systems

A. Shallow-placed systems are systems which utilize a natural, undisturbed soil horizon to treat and disperse effluent where the infiltrative surface is placed at a depth of less than 18 inches from the original soil surface. Also see Table 4.3. Shallow-placed systems may use the system designs similar to in-ground systems; however, when shallow-placed systems are installed at less than 12 inches from the ground surface, timed dosing shall be used to disperse the effluent.

B. Septic effluent prohibited. Septic tank effluent is prohibited for use in shallow-placed systems because of the increased likelihood for human and vector contact with effluent.

C. Soil criteria when utilizing secondary effluent. Secondary or better effluent may be utilized in an shallow-placed system when all of the criteria in this subsection are met. Also see Table 4.3.

1. Soil texture. In order to assure effluent dispersal under adverse conditions while maintaining adequate treatment capacity, shallow-placed systems installed shallower than 12 inches, which utilize absorption trenches, are limited to Texture Group I and II soils. Any soil texture group may be utilized for absorption trench systems installed between 12 and 18 inches.

2. Limiting features. A minimum of 12 inches of soil is required beneath the trench bottom or infiltrative surface before encountering soils with a seasonal or permanent water table. Additionally, to assure adequate hydraulic dispersal capacity, bedrock and impervious strata may not occur within 18 inches of the trench bottom.

3. Separation distances. Table 4.2 contains the minimum setback distances between an absorption field and various structures or topographic features.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

Article 3 Systems Using Fill Material

12VAC5-610-597 Fill systems

A. Fill systems are systems where the infiltrative surface and some portion of the treatment medium is comprised of fill material and not a naturally occurring undisturbed soil. Fill systems may be located in-ground, shallow-placed, or above ground. Fill systems addressed in these regulations are the Wisconsin Mound system, the noncarbonaceous mountain colluvium system, and the sand-on-sand system.

B. Elevated Sand Mounds. Septic tank effluent may be utilized with elevated sand mounds. Pretreatment shall be required when effluent strength exceeds residential strength wastewater and may be required where hydrologic conditions meet the minimum criteria contained in this chapter. For the purpose of siting an elevated sand mound, the criteria in Table 4.4 shall apply. For the purposes of establishing minimum setback distances between an elevated sand mound and various structures or topographic features, the mound shall be considered an absorption field and distances shown in Table 4.2 utilized.

C. Sand-on-sand systems. Sand-on-sand is a process of modifying a soil absorption system site using fill material which is similar in texture to the original, naturally occurring material. Filling is accomplished in accordance with 12VAC5-610-965.

1. Criteria for utilizing septic effluent. Septic tank effluent may be utilized with sand-on-sand systems. For the purpose of siting a sand-on-sand system, the criteria in Table 4.4 shall apply. Sand-on-sand systems may be utilized with septic tank effluent when the following criteria are met:

a. Soil texture. In order to assure effluent dispersal under adverse conditions, while maintaining adequate treatment capacity, shallow-placed systems are limited to Texture Group I and IIa soils. The use of Texture Group IIb, III and IV soils for sand-on-sand systems is prohibited.

b. Soil structure. Sand-on-sand is restricted to soils classified as entisols (i.e., a young soil with no horizon development) and which have a texture of sand, loamy sand, coarse sandy loam, or sandy loam texture.

c. Depth of soil. A minimum of 18 inches of naturally occurring undisturbed soil, measured from the ground surface, is required before encountering soils with bedrock, or a seasonal or permanent water table. Additionally, to assure adequate hydraulic dispersal capacity, no restrictive horizons may occur within 30 inches of the ground surface.

d. Separation distances. Table 4.2 contains the minimum setback distances between an absorption field and various structures or topographic features.

e. Estimated or measured infiltration rates. When siting a sand-on-sand system, the estimated or measured infiltration rate shall not exceed 30 minutes per inch within the sidewall area of the trench or within 18 inches of the infiltrative interface where effluent encounters undisturbed soil.

f. Slope. Sand-on-sand is prohibited where the slope of the original site exceeds 5%.

2. Criteria for utilizing secondary effluent.

a. Depth of soil. A minimum of 12 inches of soil, measured from the ground surface, is required before encountering bedrock, or a seasonal or permanent water table. Additionally, to assure adequate hydraulic dispersal capacity, no restrictive horizons may occur within 24 inches of the ground surface.

b. Separation distances. Table 4.2 contains the minimum setback distances between an absorption field and various structures or topographic features.

c. Estimated or measured infiltration rates. The estimated or measured infiltration rate shall not exceed 30 minutes per inch within the sidewall area of the trench, if any, or within 18 inches of the infiltrative interface where effluent encounters undisturbed soil.

D. Fill systems in mountain colluvium. The criteria for conventional, in-ground trench systems contained in Table 4.3 shall be complied with to the greatest extent possible. However, fill material consisting of colluvial soil derived from sandstone (noncarbonaceous) in the mountainous area may be considered on a case-by-case basis for placement of subsurface soil absorption systems.

| Table 4.1. Minimum Separation Distances for Pretreatment Units, Conveyance Lines, and Header Lines. | | | --- | --- | | Structure or Topographic Features | Minimum Horizontal Distance | | Property Lines | 5 | | Building Foundations | 10 | | Basements | 20 | | Drinking Water Wells (all classes) | 50 | | Cisterns Bottom Elevation Lower than Ground Surface in Area of Pretreatment Unit) | 100 | | Shellfish Waters | 70 | | Natural Lakes & Impounded Waters and Streams | 50 | | Developed Springs (when the spring is down slope) | 100 | | Drainage Ditches: | | | Ditch Bottoms above Seasonal Water Table | 10 | | Ditch Bottom below Seasonal Water Table and Ditch Normally Contains Water | 50 | | Lateral Ground Water Movement Interceptor | 50 | | Low Point of Sink Holes When Placed within the Bowl of the Sink Hole | 100 | | Utility Lines | 10 |

| Table 4.2. Minimum Separation Distances. | | | | | --- | --- | --- | --- | | Structure or Topographic Features | Soil Texture Group | Minimum Distance (Ft) from Bottom or Sidewall of Subsurface Soil Absorption System Trench | | | | | Vertical | Horizontal | | Property Lines | I, II, III, IV | -- | 5 | | Building Foundations | I, II, III, IV | -- | 10 | | Basements | I, II, III, IV | -- | 20 | | Drinking Water Wells | | | | | Class IIIA or IIIB | I, II, III, IV | -- | 50 | | Class IIIC or IV | I, II, III, IV | -- | 100 | | Cisterns (Bottom Elevation Lower than Ground Surface in Area of Subsurface Soil Absorption System) | I, II, III, IV | -- | 100 | | Shellfish Waters | I, II, III, IV | -- | 70 | | Natural Lakes & Impounded Waters | I, II, III, IV | -- | 50 | | Streams | I, II, III, IV | -- | 50^a | | Developed Springs (when the spring is down slope) | I, II, III, IV | -- | 200^e | | Rock and Rock Outcropping | I | 2 | 2 | | Rock and Rock Outcropping | II, III, IV | 1.5 | 1.5 | | Pans and Impervious Strata | I, II, III, IV | 1.5 | 1.5 | | Drainage Ditches: | | | | | Ditch Bottoms above Seasonal Water Table | I, II, III, IV | -- | 10 | | Ditch Bottom below Seasonal Water Table and Ditch Normally Contains Water | I | -- | 70^a | | II | -- | 70^a | | | III | -- | 50^a | | | IV | -- | 50^a | | | Water Table Depressor System | I | 6^b | 70 | | II | 3^b | 70 | | | III | 2^b | 50 | | | IV | 2 | 50 | | | Lateral Ground Water | I | -- | 70^c 10^d | | Movement Interceptor | II | -- | 70^c 10^d | | III | -- | 50^c10^d | | | IV | -- | 50^c 10^d | | | Low Point of Sink Holes When Placed within the Bowl of the Sink Hole | I, II, III, IV | -- | 100 | | Utility Lines | I, II, III, IV | -- | 10 | | ^aThe set back distance may be reduced to 10 feet in Group III and IV soils and 20 feet in Group I and II soils if the subsurface soil absorption system is designed to produce unsaturated flow condition in the soil. ^bVertical Distance to the invert of the drain tile in the water table depressor system. ^cAbsorption trench up slope from interceptor. ^dAbsorption trench down slope from interceptor. ^eArc of 180 degree up slope of spring and 100 ft. down slope. | | | |

| Table 4.3. Summary of Separation Distances between Systems Using Naturally Occurring Undisturbed Soils and Limiting Site Factors. | | | | | | --- | --- | --- | --- | --- | | Site Factor | In-Ground System¹ | Shallow-Placed System¹ | | | | Septic Tank Effluent | Secondary Effluent | Septic Tank Effluent | Secondary Effluent | | | Bed Rock | 18" | 12" | n/a | 18" | | Restriction | 18" | 12" | n/a | 18" | | Shrink-Swell Soil | 18" | 12" | n/a | 18" | | Slope | 50% | 50% | n/a | 50% | | Perc Rate | 5-120 mpi | 5-120 mpi | n/a | 5-45 mpi | | Water Table | 18" | 12" | n/a | 12" | | ¹The separation distances for in-ground and shallow-placed systems are measured from the trench bottom or other infiltrative interface vertically down to listed site factor. | | | | |

| Table 4.4. Summary of Separation Distances between Fill Systems and Limiting Site Factors. | | | | | | | | --- | --- | --- | --- | --- | --- | --- | | | Elevated Sand Mound | Sand-on-Sand System² | Noncarbonaceous Mountain Colluvium | | | | | Site Factor | Septic Tank Effluent | Secondary Effluent | Septic Tank Effluent | Secondary Effluent | Septic Tank Effluent | Secondary Effluent | | Bed Rock | 24"¹ | 24"¹ | 60" | 60" | 18" | 12" | | Restriction | 24" | 12" | 30" | 24" | 18" | 12" | | Shrink-Swell Soil | 24" | 12" | 40" | 30" | 18" | 12" | | Slope 25% | 25% | 25% | 5% | 5% | 50% | 50% | | Perc Rate | 5-120 mpi | 5-120 mpi | 5-30 mpi | 5-30 mpi | 5-120 mpi | 5-120 mpi | | Water Table | 24" | 10" | 18" | 12" | 18" | 12" | | ¹24 inches refers to creviced bedrock. This distance may be reduced to 12 inches when noncreviced bedrock is encountered. See the Wisconsin Mound Soil Absorption System Siting, Design, and Construction Manual, January 1990. | | | | | | | | ²The separation distance for sand-on-sand systems is measured from the ground surface vertically down to the listed site factor. | | | | | | |

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

Article 4 Pump and Haul of Sewage

12VAC5-610-598 General

Pump and haul pertains to an unusual circumstance wherein sewage is permitted to be transported by vehicle to a point of disposal. Pump and haul includes all facilities and appurtenances necessary to collect and store the sewage for handling by a contractor having a valid sewage handling permit.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-599 Permanent pumping and hauling

Pumping and hauling on a permanent basis is prohibited unless done under the auspices and supervision of a government entity as provided for in 12VAC5-610-599.3 (see subdivision 2 of 12VAC5-610-410 for exception). Pumping and hauling for over one year shall be considered as a permanent pumping and hauling operation.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-599.1 Emergency pumping and hauling

When serious malfunctioning of an existing sewage disposal system, sewerage system or treatment works occurs, pumping and hauling may be authorized for a definite time period until the malfunctioning system can be reconstructed or repaired.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-599.2 Temporary pumping and hauling

Temporary pumping and hauling may be permitted under the following conditions:

1. It must be demonstrated that the temporary pumping and hauling of sewage is not the usual practice in order to permit premature and unplanned real estate or commercial development in an area where sewerage facilities do not exist;

2. Construction of an approved sewerage system or treatment works is actively in progress with personnel and machinery at work in the particular area. Bonding, cash escrow or other assurances shall be required to guarantee completion of the sewerage system and/or treatment works;

3. The completion of the sewerage system or treatment works is assured and a completion date within the definition of temporary pumping and hauling has been set; and

4. Any and all delays from the anticipated completion date shall be reported immediately by the holder of the pump and haul permit to the district or local health department. Delays not resulting from circumstances beyond the control of the holder of the pump and haul permit shall be grounds for revocation of the pump and haul permit.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-599.3 Permanent pump and haul

Permanent pumping and hauling of sewage may be permitted under the following conditions:

1. That the government entity enter into a contract with the department setting forth that the government entity will provide pump and haul services, either directly or through a private contractor holding a sewage handling permit, to the home(s), commercial establishment(s) or occupied structure(s) for the period the occupied structure is utilized or until connection can be made to an approved sewerage facility;

2. Upon completion of the contract between the department and the government entity, the commissioner shall issue a single pump and haul permit to the government entity. A separate construction permit shall be issued to the government entity for each sewage storage facility. The sewage storage facility(s) shall be designed and constructed in accordance with Article 7 (12VAC5-610-990 et seq.) of Part V of this chapter; and

3. When the government entity provides the sewage pump and haul services, it shall conform to the conditions contained in 12VAC5-610-380 and Article 8 (12VAC5-610-1020 et seq.) of Part V of this chapter.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

Article 5 Installation of Residential Sewage Disposal Systems in Political Subdivisions Having Soil Drainage Management Contracts with the State Health Department

12VAC5-610-600 General

Article 5 Installation of Residential Sewage Disposal Systems in Political Subdivisions Having Soil Drainage Management Contracts with the State Health Department

It is the policy of the department to grant sewage disposal system permits for private residential systems utilizing subsurface soil absorption whenever such permits can be granted without endangering public health. Many soils are limited in their ability to accept sewage by high seasonal water tables. Some soils can accept sewage when an adequate local plan for soil drainage exists. When a political subdivision enters into a Soil Drainage Management Contract with the department and subsequently develops Soil Drainage Management Plan(s) in an area in which soils respond to artificial drainage and the plan is acceptable to the department, the department will consider the approval of subsurface soil absorption systems in soils that were previously unacceptable because of high seasonal water tables.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 3.16, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-610 Definitions

The following words and terms, when used in this article, shall have the following meanings, unless the context clearly indicates otherwise.

"Soil Drainage Management Contract (SDMC)" means a contract between the department and the political subdivision for the development, operation, maintenance, and enforcement of all soil drainage management plans within the political subdivision.

"Soil Drainage Management Plan (SDMP)" means a plan approved by the commissioner, pursuant to 12VAC5-610-630 below, meeting the criteria set forth in 12VAC5-610-640 below.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 3.17, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-620 Applicability

This article shall be applicable only in those political subdivisions which enter into Soil Drainage Management Contracts with the department.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 3.18, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-630 Procedures for entry into or withdrawal from a Soil Drainage Management Contract (SDMC)

A. Entry.

1. Any political subdivision in the Commonwealth may at any time apply to the department through the district or local health department for entry into an SDMC with the department. The application shall contain the following minimum elements:

a. A proposed contract between the department and the political subdivision; and

b. Drafts of all ordinances, required easements, or other legal documents which the political subdivision proposes to adopt as a portion of the SDMC including a local ordinance requiring the holder of a sewage disposal construction permit issued in conjunction with the SDMC to have the permit recorded in the land records of the circuit court having jurisdiction.

2. The department shall, within 60 days of the submission of an application for entry into an SDMC, evaluate the application and propose to the political subdivision any suggestions for modification to the SDMC.

3. The political subdivision may review the department's suggested modifications and resubmit a revised application within such time as the political subdivision elects.

4. The department shall accept or reject entry into an SDMC within 90 days of receipt of the final application from a political subdivision.

5. Upon rejection by the department of a final application for entry into an SDMC, the political subdivision may appeal the department's decision to the appropriate circuit court. The Virginia Administrative Process Act, § 9-6.14:1, et seq., shall apply to such an appeal.

B. Withdrawal.

1. If the department determines that a political subdivision is failing to abide by the terms set forth in its SDMC with the department, the department may withdraw from the contract.

2. The department shall, within 60 calendar days of its proposed withdrawal from an SDMC notify the political subdivision of the department's intent.

3. The political subdivision may apply to the department for a hearing upon the proposed withdrawal. Such hearing shall be held in accordance with the provisions governing case decisions contained within the Virginia Administrative Process Act.

4. Within 30 calendar days after such hearing, the department shall notify the political subdivision whether the department will withdraw from the SDMC.

5. A decision by the department to withdraw from an SDMC may be appealed to the appropriate circuit court pursuant to the provisions of the Virginia Administrative Process Act.

6. If withdrawal occurs, continued maintenance of all SDMP's shall be the responsibility of the political subdivision in areas where permits were issued in accordance with this chapter.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 3.19, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-640 Minimum standards for Soil Drainage Management Plans

A. Every SDMP offered in conjunction with a SDMC shall meet the following minimum standards for surface and groundwater management.

B. The SDMP shall provide for:

1. Positive surface grading in the area of a dwelling and subsurface soil absorption area at a minimum of 0.5%;

2. Drainage ditches for diverting surface water and for lowering the seasonal groundwater table which shall:

a. Completely surround the subsurface soil absorption system;

b. Have a minimum grade of 0.2%;

c. Be located 70 feet, ±10 feet from the drainfield; and

d. Have the invert of the ditch placed in a Group I, II or III soil at an elevation so that the normal water surface in the ditch is at least six inches below the invert of the trench of the subsurface soil absorption system;

3. A French drain on one side in lieu of an open drainage ditch on one of the four sides;

4. Diversion ditches or swales shall be:

a. Required where adjacent property is equal to or higher in elevation than the proposed site and the adjacent property may be expected to discharge water onto the proposed site;

b. Designed to meet such site specific individual requirements as the department determines to be necessary;

5. A receiving stormwater and groundwater drainage system which is adequate in capacity so that waters from a proposed site shall be conveyed to it in accordance with the political subdivision's criteria;

6. Diversion ditches, where required, or other ditches to transport stormwater and/or groundwater from a site to a receiving body in accordance with the political subdivision's criteria;

7. Ditches to remain open and not be piped and covered unless approved by appropriate local government official, such approval to be granted only with the concurrence of the department;

8. Only appurtenances to the subsurface soil absorption system shall be constructed within the confines of the perimeter ditches required in paragraph B 2 a, above, except where a French drain is provided on one side; and

9. Lots which shall be a minimum of three acres in size not including swamps or marshland.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 3.20, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-650 Department procedures relating to subsurface soil absorption system applications in SDMC counties and cities

A. All applications for subsurface soil absorption systems will be evaluated based on the criteria contained in this part. When the site is limited only by a high seasonal water table and/or surface runoff, the department shall require that a satisfactory SDMP be in place and functioning satisfactorily before issuance of a construction permit. Typed on the construction permit will be the following statement which shall be signed by the applicant:

I understand that this soil has severe limitations for the disposal of septic effluent. With the aforementioned drainage measures the health department expects reasonable serviceability, however, it may malfunction during extreme conditions.

I understand and acknowledge the above and agree to install and maintain the drainage measures.

Signed

Date

B. Soils to be considered shall demonstrate their ability to be artificially drained and shall fall generally into Texture Group I, II, or III.

C. The SDMP and site specific drainage system or systems shall be certified, supervised, maintained, and prepared by or under the direct supervision of a professional engineer licensed in Virginia who is a full-time employee of the political subdivision. In addition, the political subdivision shall have the manpower or other capability to maintain the applicable conditions of the SDMP. This certification shall become a part of the subsurface soil absorption system permit.

D. Proper easements shall be provided for drainage to assure access for proper maintenance.

E. Political subdivisions shall assure proper installation and maintenance of the stormwater and ground water drainage system or systems.

F. The department retains the right to reject any SDMP if in the opinion of the department the SDMP proposed will result in a nuisance or health hazard condition.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 3.21, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

Article 1 General Requirements

12VAC5-610-660 General

The criteria contained in this section shall apply to all onsite sewage disposal systems. Deviations from these criteria may be considered by the district or local health department on a case-by-case basis.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.1, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-670 Sewage flows

Subsurface soil absorption systems shall be designed on the basis of the sewage flows tabulated in Table 5.1.

| Table 5.1. Sewage Flows. | | | | | | | | --- | --- | --- | --- | --- | --- | --- | | Discharge Facility | Design Unit | Flow (gpd) | BOD (#/day) | S.S. (#/day) | Flow Duration (Hour) | | | | | | | | | | | Dwelling¹ | per person total | 75 | 0.2 | 0.2 | 24 | | | Food preparation | -- | 15 | -- | -- | -- | | | Toilet facilities | -- | 20 | -- | -- | -- | | | Bathing facilities | -- | 20 | -- | -- | -- | | | Handwashing facilities | -- | 5 | -- | -- | -- | | | Laundering | -- | 15 | -- | -- | -- | | | Schools with shower and cafeteria | per person | 16 | 0.04 | 0.04 | 8 | | | Schools without showers and with or without cafeteria | per person | 10 | 0.025 | 0.025 | 8 | | | Boarding schools | per person | 75 | 0.2 | 0.2 | 16 | | | Motels at 65 gals/ person (rooms only) | per person | 130 | 0.26 | 0.26 | 24 | | | Trailer courts | per person | 75 | 0.2 | 0.2 | 24 | | | Restaurants | per seat | 50 | 0.2 | 0.2 | 16 | | | Interstate or through highway restaurants | per seat | 100-180 | 0.7 | 0.7 | 16 | | | Interstate rest areas | per person | 5 | 0.01 | 0.01 | 24 | | | Service stations | per vehicle served | 10 | 0.01 | 0.01 | 16 | | | Factories & office buildings | per person per 8-hr shift | 15-35 | 0.03-0.07 | 0.03-0.07 | operating period | | | Shopping centers | per 1,000 ft. of ultimate floor space | 200-300 | 0.1 | 0.1 | 12 | | | Hospitals | per bed | 300 | 0.6 | 0.6 | 24 | | | Nursing homes | per bed | 200 | 0.3 | 0.3 | 24 | | | Homes for the aged | per bed | 100 | 0.2 | 0.2 | 24 | | | Doctor's office in medical center | per 1,000 sq. ft. | 500 | 0.1 | 0.1 | 12 | | | Laundromats, 9 to 12# machines | per machine | 500 | 0.3 | 0.03 | 16 | | | Community colleges | per student and faculty | 15 | 0.03 | 0.03 | 12 | | | Swimming pools | per swimmer | 10 | 0.001 | 0.001 | 12 | | | Theaters, drive-in type | per car | 5 | 0.01 | 0.01 | 4 | | | Theaters, auditorium type | per seat | 5 | 0.01 | 0.01 | 12 | | | Picnic areas | per person | 5 | 0.01 | 0.01 | 12 | | | Camps, resort day and night with limited plumbing | per campsite | 50 | 0.05 | 0.05 | 24 | | | Luxury camps with flush toilets | per campsite | 100 | 0.1 | 0.1 | 24 | | | Dump station | per campsite | 50 | 0.05 | 0.05 | 24 | | | ¹ For all dwelling units the design shall be based on two persons per bedroom. | | | | | | |

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.2, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-680 Water saving plumbing devices

Water saving plumbing devices are encouraged to lengthen the life of the subsurface soil absorption system. However, only permanent water saving plumbing devices such as low flush toilets shall be considered in reducing the size of the absorption area. Devices such as inserts in showers are considered temporary.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.3, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-690 Recycle and reuse systems

Recycle and reuse systems are methods, processes and equipment in which sewage is restored to a condition suitable for reuse. When recycle and reuse systems are utilized in conjunction with toilet wastes only, an approved method of sewage disposal shall be provided to properly dispose of sewage generated via handwashing and other related sanitation activities. All recycle and reuse systems shall provide for an approved method of sewage disposal to handle excess sewage generated within the system. These systems are considered experimental unless they have been previously deemed to be satisfactory in accordance with the provisions of 12VAC5-610-441 and/or as a minimum have been certified by the National Sanitation Foundation as meeting the current Standard 41 as determined by the bureau. Water recycle and reuse systems intended to produce water for other than toilet flush water are considered experimental and shall comply with the provisions of 12VAC5-610-441. All proposals for recycle and reuse systems shall be submitted to the bureau through the district or local health department.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.4, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-700 Site preparation and alteration

A. Preservation of soil structure. The preservation of the original structure of the soil in the area selected for placement of the absorption trenches is essential to maintaining the percolative capacity of the soil.

1. Prohibition on construction. Subsurface soil absorption systems shall not be constructed in Texture Group III and IV soils during periods of wet weather when the soil is sufficiently wet at the depth of installation to exceed its plastic limit. For the purpose of this chapter, the plastic limit of a soil shall be considered to have been exceeded when the soil can be rolled between the palms of the hands to produce threads 1/8 inch in diameter without breaking apart and crumbling.

2. Soil compaction. Special caution shall be taken in allowing wheeled and tracked vehicles to traverse the area selected for placement of the absorption systems before, during and after construction of the trenches, especially during wet weather. Precaution is especially important where Texture Group III and IV soils are involved. Alteration of soil structure by movement of vehicles may be grounds for rejection of the site and/or system or revocation of the permit.

3. Soil smearing. Excavating equipment utilized to construct the absorption system shall be so designed as not to compress or smear the sidewalks or bottom of the system. Excessive smearing of the usable absorption trench sidewalls or bottom during construction may result in irreversible damage to the soil infiltrative surface and may be grounds for rejection of the site and/or system.

B. Removal of vegetation. Vegetation such as maple, cottonwood, willows and other plant species with extremely hydrophilic (water loving) root systems shall be removed for a minimum of 10 feet from the actual absorption areas. Other trees should be removed from the absorption area.

C. Grading.

1. Pregrading. The proposed site for the subsurface soil absorption system shall not be graded until the district or local health department has completed the site evaluation contained in Article 1 (12VAC5-610-450 et seq.) of Part III of this chapter.

2. Interim grading. Interim grading means site grading during or immediately preceding the construction of the absorption system. Any such grading shall be done in accordance with the conditions contained in the construction permit. The district or local health department may require notification upon completion of the interim grading but before actual installation of the absorption system.

3. Final grading. Final grading of the absorption area site for diversion of surface water (e.g., crowning) for the purpose of eliminating surface water from flowing or ponding on the site, preparation for seeding, etc. shall be accomplished to avoid damaging the absorption area. Prior to grading, the distribution box, pretreatment unit and absorption area shall be clearly staked.

D. Drainage.

1. Surface water. The area surrounding the absorption area shall be graded to divert surface water from the absorption area site. The absorption area site shall also be graded to eliminate the ponding of water.

2. Roof drains, basement sump discharges (nonsewage), floor drains, footing drains, etc., are prohibited from being connected to the sewage disposal system and shall be directed away from the absorption area site in a manner to preclude water flow into, through or over the site. Discharge of sewage into a basement sump collecting water from floor drains, storm water, etc., is prohibited.

3. Lateral ground water movement interceptors (LGMI, e.g., French drains) may be required to divert ground water movement away from the absorption area site. The LGMI shall be placed perpendicular to the general slope of the land and generally parallel to the absorption trenches. A tight drain from the LGMI shall be constructed to discharge into a natural or manmade drainage way.

E. Protection of subsurface soil absorption system.

1. No structures shall be placed over the subsurface soil absorption system. Driveways or parking lots shall not be constructed on the subsurface soil absorption system unless the invert of the lead or header lines or top of the gravel in the absorption trenches is deeper than 30 inches below the ground surface and the driveway or parking lot is paved with portland cement or bituminous concrete to prevent compaction of the trench bottom. Driveways and parking lots shall not be constructed over the distribution box unless adequate structural and access provisions are provided.

2. Where all or part of a subsurface soil absorption system is proposed to be installed on property other than the owners, an easement in perpetuity shall be recorded with the clerk of the court prior to issuance of a construction permit (see 12VAC5-610-280). The easement shall be of sufficient area to permit access, construction, required reserve area (see 12VAC5-610-710), and maintenance of the system.

3. Where the sewer line from the building to the pretreatment unit or the conveyance line is to be placed underneath a state road or in a Virginia Department of Transportation right-of-way, the requirement for a recorded easement in perpetuity can be waived for that portion of the system located underneath the road or in the right-of-way. In its place, the applicant shall obtain the appropriate permit or permits from the Department of Transportation to construct the sewer or conveyance line in its right-of-way. The construction permit for the sewage disposal system shall not be issued until the applicant provides the local health department with a copy of the permit issued by the Department of Transportation. Under no circumstances shall the pretreatment unit, the distribution box, or the soil absorption portion of the system be installed in the Department of Transportation right-of-way.

F. Preplacement and post-placement of utilities. Subsurface soil absorption systems shall not be placed in an underground utility easement. No buried public or private utility service (e.g., water lines, electrical lines, gas lines, etc.) shall traverse the subsurface soil absorption system area nor shall the buried service be closer than 10 feet to the system.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.5, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-710 Reserve absorption area sites

Separate reserve area or areas meeting the requirements of Part III, Article I of this chapter and equalling 50% of the required absorption area shall be provided where the estimated or measured percolation rate exceeds 45 minutes/inch.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.6, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

Article 2 Building Sewers

12VAC5-610-720 General

Sewers referred to in this section are watertight, smooth bore, rigid conduits which convey sewage from a building drain to a pretreatment unit and are not to be confused with public sewers addressed in the Sewerage Regulations. (See 12VAC5-580-10 et seq.)

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.7, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-730 Minimum size

Sewers shall have a minimum internal diameter (ID) of three inches. Larger sewers may be required depending on projected flows.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.8, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-740 Slope

The minimum slope for three- and four-inch sewers is 1-1/4 inches per 10 feet, and for a six-inch sewer is 3/4 inch per 10 feet.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.9, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-750 Materials

All sewers shall be of cast iron (CI) pipe not less than service weight, schedule 40 plastic pipe, extra strength vitrified clay or other acceptable materials to be evaluated on a case-by-case basis. Bituminous fiber pipe is prohibited. Sewers passing under driveways shall be heavy duty CI or schedule 40 plastic pipe, or other acceptable material to be evaluated on a case-by-case basis.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.10, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-760 Sewer appurtenances

A. Joints. Sewer joints shall be of the compression type except that plastic pipe may be welded sleeve or chemically fused.

B. Adapters. Joining of pipes of different sizes and/or material shall be accomplished by use of a manufactured adapter specifically designed for that purpose.

C. Bends. The building sewer shall have a straight alignment where possible. When a straight alignment is not possible ells not exceeding 45 degrees shall be used.

D. Cleanouts. Cleanouts shall be brought to the ground surface and shall be provided every 50 feet to 60 feet along the length of the building sewer. Cleanouts shall be brought to the ground surface for access.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.11, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-770 Sewer construction

A. Location. Sewers passing within 50 feet of a nonpublic drinking water supply well or other nonpublic drinking water supply source shall have special construction and pipe materials to provide adequate protection. Special construction constitutes water pipe meeting AWWA specifications, pressure tested (10 feet of water) in place without leakage prior to backfilling. However, under no circumstances shall a sewer come within 10 feet of a nonpublic drinking water supply source.

B. Above grade installation. Sewers constructed above grade shall be adequately supported and protected against freezing. When plastic pipe is used for above grade installation the pipe must be protected against ultraviolet radiation, i.e. shielded against sunlight.

C. Bedding. All sewers shall be bedded to supply uniform support along the length of the sewer.

D. Backfilling and tamping. Sewer trenches shall be backfilled with suitable material free of large stones and clumps of earth and tamped to prevent movement of the sewer as soon as possible after the installation of the sewer has been approved.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.12, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

Article 3 Pretreatment Systems

12VAC5-610-780 General

As used in this article, "pretreatment" refers to treatment works designed to prepare sewage for disposal in a soil medium.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.13, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-790 Types

Three general types of pretreatment systems are described herein. They are as follows:

A. Biological;

B. Physical; and

C. Chemical.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.14, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-800 Aerobic biological systems

Aerobic biological treatment systems will be considered on a case-by-case basis at the request of the owner. These systems shall meet the applicable criteria contained in 12VAC5-640-360 of the Alternative Discharging Sewage Treatment Regulations for Individual Single Family Dwellings or 12VAC5-580-770 of the Sewerage Regulations (12VAC5-580-10 et seq.) or criteria developed by a testing laboratory or agency approved by the division. Where an activated sludge process is used to produce a secondary effluent, provisions shall be made to protect the drainfield from bulking solids. Use of an aerobic pretreatment system shall not result in the reduction of the absorption area requirements contained in Article 5 (12VAC5-610 900 et seq.) of this chapter.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.15, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-810 Anaerobic biological systems

Septic tanks are the most commonly used pretreatment systems and under normal circumstances are the most inexpensive units that give acceptable results with a minimum of maintenance.

The preferred material for use in constructing septic tanks is concrete. Other materials may be considered on a case-by-case basis. All materials must be resistant to corrosion, both chemical and electrolytic, and must have sufficient structural strength to contain sewage and resist lateral compressive and bearing loads.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.16, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-815 Septic tank design

A. Tank capacity. The minimum hydraulic detention time shall be 48 hours based on daily design flow. In no case shall the septic tank capacity be less than 750 gallons. Table 5.2 contains the minimum required septic tank capacities for dwelling units.

| Table 5.2. Septic Tank Capacities for Dwelling Units. | | | --- | --- | | No. of Bedrooms | Approximate Tank Volume in Gallons | | 1 | 750 | | 2 | 750 | | 3 | 900 | | 4 | 1200 | | 5 | 1500 |

B. Tank dimensions. Septic tanks shall be rectangular in plan, cross-section and longitudinal view. The length to liquid depth to width ratio should be approximately equal or greater than 2 to 1 to 1 (2:1:1) and less than or equal to 3 to 1 to 1 (3:1:1). In no case shall the liquid depth be less than four feet or greater than eight feet. A minimum of one foot free board shall be provided. Inlet and outlet structures shall be placed on the longitudinal axis of the tank. Typical tank dimensions are found in Table 5.3.

| Table 5.3. Typical Septic Tank Dimensions in Feet. | | | | | | --- | --- | --- | --- | --- | | Approximate Gallons | Length | Width | Liquid Depth | Freeboard | | 750 | 7 | 3.5 | 4 | 1 | | 900 | 8 | 4 | 4 | 1 | | 1200 | 9 | 4.5 | 4 | 1 | | 1500 | 9.5 | 5 | 4.7 | 1 |

C. Inlet-outlet structure.

1. General. The inlet and outlet structures shall function as a baffle. The invert of the inlet structure shall be greater than one inch but less than two inches higher than the invert of the outlet structure with the tank installed. The inlet structure shall extend six to eight inches below and eight to 10 inches above the normal liquid level. The outlet structure shall extend below the normal liquid surface to a distance of 35 to 40% of the liquid depth and eight to 10 inches above the normal liquid level. The inlet and outlet structures shall have an open space not less than four inches by four inches in cross-section or four inches in diameter.

2. Materials. All materials used for inlet and outlet structures shall have long term resistance to chemical and electrolytic corrosion. When pipe tees are used as inlet and outlet structures, the material shall be compatible with the material used in the sewer.

D. Top access and watertightness. All septic tanks shall be watertight and shall be provided with a watertight top. As a minimum, access manholes shall be provided over the inlet and outlet structures and shall have a minimum open space of 18 inches by 18 inches. When the septic tank has in excess of 30 inches of soil cover, an access manhole shall be brought to within 18 inches of the ground surface and shall be provided with a tight fitting cover. In wet areas the manhole covers shall be watertight.

E. Construction of septic tanks. The contractor and/or manufacturer shall design and construct the septic tank to withstand the lateral and bearing loads to which the septic tank is expected to be subjected.

F. Placement of septic tanks. The precast septic tank shall be bedded with at least six inches of sand or fine gravel where rock or other undesirable conditions are encountered. The tank shall be placed level. Where excavation is required, the hole shall be sufficiently large to permit placement of the tank. Backfilling the excavation for all septic tanks shall be done in layers with sufficient tamping to avoid settling. Backfill material shall be free of large stones and debris.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-817 Maintenance

A. In order to encourage proper maintenance and reduce the likelihood of solids being discharged to an absorption field, all septic tanks constructed after July 1, 2000, shall be designed to allow for routine inspection without being uncovered (i.e., have an inspection port as provided for in subsection B of this section) or have an effluent filter as provided for in subsection C of this section, or be designed for reduced maintenance as provided for in subsection D of this section.

B. Inspection port. An inspection port is a three-inch or larger port pipe or structure which allows access to the septic tank for the purpose of measuring sludge and scum accumulation. The inspection port shall terminate at or above grade and be designed to allow an inspection of sludge buildup in the septic tank. The inspection port shall be constructed of schedule 40 PVC pipe, or its equivalent, and shall be fitted with a watertight threaded cap. The recommended location of the inspection port shall be in or near the manhole cover on the inlet side of the septic tank away from the inlet tee. Other locations may be approved by the district health department on a case-by-case basis.

C. Effluent filters. An effluent filter is a device which has one or more of the following purposes: (i) to manage solids to provide greater service life to a pump or other components of an onsite system; (ii) to manage the total suspended solids (TSS) passed to the absorption field, potentially enhancing absorption field life; or (iii) some other purpose recognized as beneficial by the department.

1. All effluent filters shall be designed to improve the quality of effluent leaving the tank in a manner which is consistent with their purpose.

2. Septic tank outlet filters shall be constructed from a material which resists the corrosive nature of the environment within a septic tank.

3. A tamper proof child resistant at-grade access port shall be provided to assure the filter can be readily maintained as necessary.

D. Reduced maintenance septic tanks. Septic tanks which are sized 30% larger than shown in Table 5.3 and which are baffled such that the first compartment is nominally the volume required in Table 5.3 shall be considered to be a reduced maintenance septic tank.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-820 Miscellaneous

A. Multiple septic tanks in series. The required volume for a septic tank may be satisfied by the utilization of two septic tanks in series; however, the first septic tank in series shall equal to 1/2 to 2/3 the required total volume.

B. Physical and/or chemical systems. Physical or chemical systems, or both, utilized as pretreatment for subsurface disposal of sewage shall meet the applicable criteria contained in 12VAC5-580-930 through 12VAC5-580-960 of the Sewerage Regulations.

C. Water stop. A water stop is a method for sealing the annular space around a conduit or pipe, or both, for the purpose of preventing infiltration or exfiltration, or both. Conduits or pipes passing through the walls of a pretreatment unit shall be provided with a water stop.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.17, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-830 (Repealed.)

Historical Notes

Derived from VR355-34-02 §§ 4.18 and 4.19, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14; repealed, Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

Article 4 Conveyance Systems

12VAC5-610-850 General

For the purpose of this chapter an "effluent conveyance system" is defined as the piping, mechanical equipment and appurtenances utilized to transport effluent from a pretreatment system to a point where the flow is split for distribution to a subsurface soil absorption system.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.20, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-860 Conveyance methods

Three basic methods utilized to convey effluent are:

1. Gravity;

2. Pumping; and

3. Dosing siphons.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.21, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-870 Gravity effluent mains

A. Size. Mains transporting effluent by gravity shall have a minimum internal diameter of three inches.

B. Slope. Gravity mains shall have a slope of not less than six inches per 100 feet.

C. Materials. Gravity mains spanning disturbed soil shall meet the material specifications contained in 12VAC5-610-750. The mains shall meet the specifications until placed two feet in undisturbed soil or until termination in a structure. The remaining gravity mains shall have a minimum crush strength of 1500 pounds per foot and may be constructed of cast iron, plastic, vitrified clay or other material resistant to the corrosive action of sewage. All gravity mains shall be watertight, smooth bore, rigid conduits.

D. Appurtenances.

1. Joints. Gravity mains shall have joints of the compression type with the exception of plastic mains which may be welded sleeve or chemically fused.

2. Adapters. Joining of mains of different size and/or material shall be accomplished by use of a manufactured adapter specifically designed for that purpose.

3. Valves. Valves shall be constructed of materials resistant to the corrosive action of sewage. Valves placed below ground level shall be provided with a valve box and a suitable valve stem so that it may be operated from the ground surface.

E. Flow diversion devices. Flow diversion is a technique for increasing the useful life of an absorption area. Flow diversion provides for diversion of flow to two alternate equally sized absorption areas whose sum meets the area requirements in 12VAC5-610-950 B with a rest period of approximately one year for recovery of each absorption area. These devices shall meet the material requirements contained in paragraph D 3 of this section.

F. Construction. Construction standards for gravity effluent mains are the same as those for house sewers and are found in 12VAC5-610-770.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.22, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-880 Pumping

A. Force mains in general.

1. Velocity. At pumping capacity, a minimum self-scouring velocity of two feet per second shall be maintained. A velocity of eight feet per second should not be exceeded.

2. Air relief valve. Air relief valves shall be placed at high points in the force main, as necessary, to relieve air locking.

3. Bedding. All force mains shall be bedded to supply uniform support along their length.

4. Protection against freezing. Force mains shall be placed deep enough to prevent freezing.

5. Location. Force mains shall not pass closer than 50 feet to any drinking water source unless pressure tested in place at pump shut-off head. Under no circumstances shall a force main come within 10 feet of a nonpublic drinking water source.

6. Materials of construction. All pipe used for force mains shall be of the pressure type with pressure type joints.

7. Anchors. Force mains shall be sufficiently anchored within the pump station and throughout the line length. The number of bends shall be as few as possible. Thrust blocks, restrained joints and/or tie rods shall be provided where restraint is needed.

8. Backfilling and tamping. Force main trenches shall be backfilled and tamped as soon as possible after the installation of the force main has been approved. Material for backfilling shall be free of large stones and debris.

B. Pumping station and pumps in general.

1. Sizing. Pumping station wet wells shall provide at least one quarter (1/4) day storage above the high level alarm set point. Actual volume between high and low level limits is determined on a case-by-case basis depending on the objective of pumping: (i) when low pressure dosing is utilized see 12VAC5-610-940 A for sizing requirements; (ii) when pumping to a gravity distribution box the wet well shall be sized to provide a working volume between 1/4 the daily flow and the daily flow; (iii) when pumping for the purpose of enhancing flow distribution (see 12VAC5-610-930 A) the working volume of the wet well shall be 0.6 of the volume of the percolation piping.

2. Materials. Materials for construction of pumping stations are the same as for septic tanks (see 12VAC5-610-810). All materials and equipment utilized in pumping stations shall be unaffected by the corrosive action of sewage.

3. Access. An access manhole terminating above the ground surface shall be provided. The manhole shall have a minimum width dimension of 24 inches and shall be provided with a shoe box type cover adequately secured.

4. Construction. Pumping stations constructed of precast or poured in place concrete shall conform with the construction requirements contained in 12VAC5-610-815 E. When precast concrete pipe is utilized for a pumping station, the pipe shall be placed on and bonded to a concrete pad at least six inches thick and having a width at least one foot greater than the diameter of the pipe. All pumping stations shall be watertight. All conduits entering or leaving the pumping stations shall be provided with a water stop. The influent pipe shall enter the pumping station at an elevation at least one inch higher than the maximum water level in the wet well (total usable volume).

5. Installation. Placement of pumping stations shall conform to the requirements for placement of septic tanks contained in 12VAC5-610-815 F.

6. Pumps. All pumps utilized shall be of the open face centrifugal, vertical turbine, or suction lift type designed to pump sewage. Pumps utilized for the sole purpose of pumping effluent to a higher elevation shall have a capacity approximately 2.5 times the average daily flow in gallons per minute but not less than five gallons per minute at the system head. Pumps utilized for the purpose of enhancing flow distribution (See 12VAC5-610-930 A) shall have a minimum capacity of 36 gallons per minute at system head per 1200 linear feet of percolation piping. Pumps discharging to a low pressure distribution system shall be sized in accordance with 12VAC5-610-940 A. Dual alternating pumps are required on systems 1800 linear feet or greater in accordance with 12VAC5-610-930 B. Pumps shall be so placed that under normal start conditions it shall be subjected to a positive suction head. When multiple pumps are used, each pump shall have its own separate suction line. Suitable shutoff valves shall be provided on the discharge line and suction line (if provided) for normal pump isolation. A check valve shall be placed in the discharge line between the pump and shutoff valve. When the pump discharge is at a lower elevation than the high liquid level in the pump station, an antisiphon device shall be provided on the pump discharge. Pumps shall be piped so that they can be removed for servicing without having to dewater the wet well.

7. Controls. Each pumping station shall be provided with controls for automatically starting and stopping the pumps. When float type controls are utilized, they shall be placed so as to be unaffected by the flow entering the wet well. Provisions shall be made for automatically alternating the pumps. The electrical motor control center and master disconnect switch shall be placed in a secure location above grade and remote from the pump station. Each motor control center shall be provided with a manual override switch. The control panel shall be located to allow for working access, taking into consideration the finished ground surface elevation.

8. Alarms. A high water alarm with remote sensing and electrical circuitry separate from the motor control center circuitry shall be provided. The alarm shall be audiovisual and shall alarm in an area where it may be easily monitored. When multiple pumps are utilized, an additional audiovisual alarm shall be provided to alarm when a pump motor fails to start on demand.

9. Ventilation. Positive ventilation shall be provided at pumping stations when personnel are required to enter the station for routine maintenance.

a. Wet wells. Ventilation may be either continuous or intermittent. Ventilation, if continuous, shall provide at least 12 complete air changes per hour; if intermittent, at least 30 complete air changes per hour. Such ventilation shall be accomplished by mechanical means.

b. Dry wells. Ventilation may be either continuous or intermittent. Ventilation, if continuous, shall provide at least six complete air changes per hour; if intermittent, at least 30 complete air changes per hour. Such ventilation shall be accomplished by mechanical means.

C. Conveyance pumps and pump stations that move TL-2 effluent or TL-3 effluent to a soil dispersal system shall comply with the following.

1. Subsection A of this section shall apply, except that the minimum velocity in the force main may be reduced to one foot per second.

2. Pump station wet wells shall provide at least one-quarter-day storage above the high level alarm set point. Alternatively, storage may be provided in a treatment tank such as a recirculation tank, but the maximum water level must be one inch below the invert of the pipe from the septic tank.

3. Subdivisions B 2, B 3, B 4, B 5, B 7, B 8, and B 9 of this section shall apply.

4. All pumps utilized shall be of the open face centrifugal, vertical turbine, or suction lift type designed to pump sewage.

a. Pumps utilized for the purpose of enhancing flow distribution (See 12VAC5-610-930 A) shall have a minimum capacity of 36 gallons per minute at system head per 1,200 linear feet of percolation piping.

b. Pumps discharging to a low pressure distribution system shall be sized in accordance with 12VAC5-610-940.

c. Dual alternating pumps are required on systems 1,800 linear feet or greater in accordance with 12VAC5-610-930 B.

d. Submersible pumps shall be placed so that under normal start conditions the pump shall be subjected to a positive suction head.

e. When multiple pumps are used, each pump shall have its own separate suction line. Suitable shutoff valves shall be provided on the discharge line and suction line (if provided) for normal pump isolation. A check valve shall be placed in the discharge line between the pump and shutoff valve. When the pump discharge is at a lower elevation than the high liquid level in the pump station, an anti-siphon device shall be provided on the pump discharge. Pumps shall be piped so that they can be removed for servicing without having to dewater the wet well.

D. Pumps integral to treatment systems are pumps that move wastewater within the treatment unit and are required to achieve the desired effluent quality. Subsections A, B, and C of this section do not apply to these integral pumps.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.23, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000; Volume 39, Issue 4, eff. November 24, 2022.

12VAC5-610-890 Siphons

A. Use. Intermittent dosing siphons have two major uses:

1. Low pressure dosing of subsurface soil absorption systems (see 12VAC5-610-940); or

2. To provide more uniform distribution of effluent to large or multiple sectioned subsurface soil absorption systems which split the flow 12 or more times or contain 1200 linear feet or more of percolation piping (see 12VAC5-610-930 A and B).

B. Materials. Materials for construction of dosing siphon chambers are the same as for septic tanks (see 12VAC5-610-810).

C. Number and sizing. Dosing siphons discharging to subsurface soil absorption systems shall have an average discharge rate greater than 2.5 times the average daily influent flow in gallons per minute but not less than 70 gallons per minute per 1200 linear feet of percolation lines. Twin alternating siphons are required where the system to be dosed exceeds 1800 linear feet in accordance with 12VAC5-610-930 B. The volume of the dosing chamber shall equal 0.6 the volume of the percolation piping for enhanced flow distribution. Actual dosing chamber volume is determined on a case-by-case basis where low pressure distribution is utilized (see 12VAC5-610-940 A).

D. Access. The siphon chamber shall terminate at or above the ground surface. The top of the chamber shall be removable to an extent to allow access for maintenance, repairs and removal of the siphon components.

E. Construction. Dosing chambers constructed of precast or poured in place concrete shall conform with the construction requirements contained in 12VAC5-610-815 E.

F. Force mains. Force mains used in conjunction with siphons shall meet the applicable criteria contained in 12VAC5-610-880 A.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.24, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

Article 5 Subsurface Soil Absorption System

12VAC5-610-900 General

Subsurface soil absorption systems are sewage disposal systems which utilize the soil to further treat and dispose of effluent from a treatment works in a manner that does not result in a point source discharge and does not create a nuisance, health hazard or ground or surface water pollution.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.25, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-910 Scope

For the purpose of this chapter, a "subsurface soil absorption system" shall refer to that part of a sewage disposal system beginning at the flow splitting device and extending through the absorption area or areas.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.26, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-920 Distribution methods

The term distribution methods refers to the piping, flow splitting devices, gravel, and other appurtenances beginning at the point of flow splitting and ending at the application of effluent to the soil absorption area. Two basic methods are considered:

A. Gravity; and

B. Pressure.

History

• Statutory Authority: §§ 32.1-12, 32.1-164, and 32.1-164.9 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 1.3, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-610-930 Gravity distribution

Gravity distribution is the conveyance of effluent from a distribution box through the percolation lines at less than full flow conditions. Flow to the initial distribution box may be initiated by pump, siphon or gravity.

A. Enhanced flow distribution. Enhanced flow distribution is the initiation of the effluent flow to the distribution box by pump or siphon for the purpose of assuring more uniform flow splitting to the percolation lines. Enhanced flow distribution shall be provided on systems where the flow is split more than 12 times or the system contains more than 1200 linear feet of percolation lines. For the purpose of this chapter, enhanced flow distribution is considered to produce unsaturated soil conditions.

B. System size. Distribution systems containing 1800 or more linear feet of percolation piping shall be split into multiple systems containing a maximum of 1200 linear feet of percolation piping per system.

C. Distribution boxes. The distribution box is a device for splitting flow equally by gravity to points in the system. Improperly installed distribution boxes are a cause for absorption field malfunction.

1. Materials. The preferred material for use in constructing distribution boxes is concrete (3000 psi). Other materials may be considered on a case-by-case basis. All materials must be resistant to both chemical and electrolytic corrosion and must have sufficient structural strength to contain sewage and resist lateral compressive and bearing loads.

2. Design. Each distribution box shall be designed to split the influent flow equally among the multiple effluent ports. All effluent ports shall be at the same elevation and be of the same diameter. The elevation of the effluent ports shall be at a lower elevation than the influent port. The placement of the influent ports shall be such as to prevent short circuiting unless baffling is provided to prevent short circuiting. The minimum inside width of a gravity flow distribution box shall be equal to or greater than 12 inches. The inside bottom shall be at least four inches below the invert of the effluent ports and at least five inches below the invert of the influent port. A minimum of eight inches freeboard above the invert of the effluent piping shall be provided. The distribution box shall be fitted with a watertight, removable lid for access.

3. Installation. The hole for placement of the distribution box shall be excavated to undisturbed soil. The distribution box shall be placed in the excavation and stabilized. The preferred method of stabilizing the distribution box is to bond the distribution box to a four inch poured in place Portland cement concrete pad with dimensions six inches greater than the length and width dimensions of the distribution box. The box shall be permanently leveled and checked by water testing. Conduits passing through the walls of a distribution box shall be provided with a water stop.

D. Lead or header lines. Header or lead lines are watertight, semirigid, or rigid lines that convey effluent from a distribution box to another box or to the percolation piping.

1. Size. The lead or header lines shall have an internal diameter of four inches.

2. Slope. Minimum slope shall be two inches per 100 feet.

3. Materials. The lead or header lines shall have a minimum crush strength of 1500 pounds per foot and may be constructed of cast iron, plastic, vitrified clay, or other material resistant to the corrosive action of sewage.

4. Appurtenances.

a. Joints. Lead or header lines shall have joints of the compressions type with the exception of plastic lead or header lines that may be welded sleeve, chemically fused, or clamped (noncorrosive) flexible sleeve.

b. Adapters. Joining of lead or header lines of different size or material shall be accomplished by use of a manufactured adapter specifically designed for the purpose.

c. Valves. Valves shall be constructed of materials resistant to the corrosive action of sewage. Valves placed below ground level shall be provided with a valve box and a suitable valve stem so that it may be operated from the ground surface.

5. Construction.

a. Bedding. All lead or header lines shall be bedded to supply uniform support and maintain grade and alignment along the length of the lead or header lines. Special care shall be taken when using semirigid pipe.

b. Backfilling and tamping. Lead and header lines shall be backfilled and tamped as soon as possible after the installation of the lead or header lines has been approved. Material for backfilling shall be free of large stones and debris.

6. Termination. Header or lead lines shall extend for a minimum distance of two feet into the absorption trenches.

E. Gravity percolation lines. Gravity percolation lines are perforated or open joint pipes that are utilized to distribute the effluent along the length of the absorption trenches.

1. Size. All gravity percolation lines shall have an internal diameter of four inches.

2. Slope. The slope of the lines shall be uniform and shall not be less than two inches or more than four inches per 100 feet.

3. Design. Effluent shall be split by the distribution system so that all gravity percolation lines installed shall receive an equal volume of the total design effluent load per square foot of trench, i.e., the fraction of the flow received by each percolation line divided by the length of the gravity percolation lines shall be equal for all gravity percolation lines in a system.

4. Length. No individual gravity percolation line shall exceed 100 feet in length.

5. Materials.

a. Clay. Clay tile shall be extra-strength and meet current ASTM standards for clay tile.

b. Perforated plastic drainage tubing. Perforated plastic drainage tubing shall meet ASTM standards. At not greater than 10 feet intervals the pipe shall be plainly marked, embossed, or engraved thereby showing the manufacturer's name or hallmark and showing that the product meets a bearing load of 1,000 lb. per foot. In addition, a painted or other clearly marked line or spot shall be marked at not greater than 10 feet intervals to denote the top of the pipe.

The tubing shall have three holes, 1/2 to 3/4 inch in diameter evenly spaced and placed within an arc of 130 degrees, the center hole being directly opposite the top marking.

Spacing of each set of three holes shall be at four inch intervals along the tube. If there is any break in the continuity of the tubing, an appropriate connection shall be used to join the tubing.

6. Installation.

a. Crushed stone or gravel. Clean gravel or crushed stone having a size range from 1/2 inch to 1-1/2 inches shall be utilized to bed the gravity percolation lines.

Minimum depth of gravel or crushed stone beneath the percolation lines shall be six inches. Clean course silica sand (does not effervesce in presence of dilute hydrochloric acid) may be substituted for the first two inches (soil interface) of the required six inches of gravel beneath the percolation lines. The absorption trench shall be backfilled to a depth of two inches over the gravity percolation lines with the same gravel or crushed stone. Clean sand, gravel, or crushed stone shall be free of fines, clay, and organic materials.

b. Grade boards or stakes. Grade boards or stakes placed in the bottom or sidewalls of the absorption trench shall be utilized to maintain the grade on the gravel for placement of the gravity percolation lines. Grade stakes shall not be placed on centers greater than 10 feet.

c. Placement and alignment. Perforated gravity percolation piping shall be placed so that the center hole is in the horizontal plane and interfaces with the minimum six inches of graded gravel. When open joint piping is utilized the upper half of the top of the 1/4-inch open space shall be covered with tar paper or building paper to block the entrance of fines into the pipe during the backfilling operation. All gravity percolating piping shall be placed in the horizontal center of the absorption trench and shall maintain a straight alignment and uniform grade.

d. Backfilling. After the placement of the gravity percolation piping the absorption trench shall be backfilled evenly with crushed stone or gravel to a depth of two inches over the piping. Untreated building paper or other suitable material shall be placed at the interface of the gravel and soil to prevent migration of fines to the trench bottom. The remainder of the trench shall be backfilled with soil to the ground surface.

F. Gravelless material is a proprietary product specifically manufactured to disperse effluent within the absorption trench of an onsite sewage system without the use of gravel. Gravelless material may include chamber, bundled expanded polystyrene, and multi-pipe systems. The division shall maintain a list of all generally approved gravelless material. Gravelless material on the generally approved list may be used in accordance with Table 5.4 of 12VAC5-610-950.

1. Gravelless material that received general approval as of December 12, 2013, shall retain such status when used in accordance with the requirements of this chapter. After December 12, 2013, the division shall review and evaluate new applications for general approval pursuant to the requirements of this chapter.

a. Any manufacturer of gravelless material may submit an application for general approval to the division using a form provided by the division. A complete application shall include the manufacturer's contact information, product specifications, product approvals in other states or territories, installation manual, and other information deemed necessary by the division to determine compliance with this chapter.

b. The manufacturer of gravelless material shall identify in the application for general approval any recommendation that deviates from the requirements of this chapter. If the recommendation is approved by the division, then the manufacturer shall include the deviation in the gravelless material's installation manual.

2. Gravelless material shall have the following minimum characteristics for general approval:

a. The minimum exterior width shall be at least 90% of the total width of the absorption trench. The exterior width of a chamber system shall be measured at the edge or outer limit of the product's contact with the trench bottom unless the division determines a different measurement is required based on the gravelless material's design. The exterior width of bundled expanded polystyrene and multi-pipe systems shall be measured using the outside diameter of the bundled gravelless material unless the division determines a different measurement is required based on the gravelless material's design. The division shall establish the exterior width of any gravelless material that is not considered a chamber, bundled expanded polystyrene, or multi-pipe system.

b. Gravelless material shall have a minimum height of eight inches to provide a continuous exchange of air through a permeable interface.

c. Gravelless material shall have a permeable interface that shall be located along the trench bottom and trench sidewalls within the absorption trench.

d. Gravelless material shall provide a minimum storage capacity of 1.3 gallons per square foot of trench bottom area.

e. Gravelless material shall pose no greater risk to surface water and groundwater quality than gravel in absorption trenches. Gravelless material shall be constructed to maintain structural integrity such that it does not decay or corrode when exposed to effluent.

f. Gravelless material shall have a minimum load rating of H-10 or H-20 from the American Association of State Highway and Transportation Officials or equivalent when installed in accordance with the manufacturer's specifications and minimum specified depth of cover in nontraffic or traffic areas, respectively.

3. For designs using gravelless material, the absorption trenches shall receive an equal volume of effluent per square foot of trench. Trench bottom area shall be equal to or greater than the minimum area requirements contained in Table 5.4 or Table 5.5 of 12VAC5-610-950. Trench sidewall shall not be included when determining minimum area requirements. When open-bottom gravelless material is utilized, it shall provide a splash plate at the inlet of the trench or other suitable method approved by the manufacturer to reduce effluent velocity.

4. Installation of gravelless material shall comply with this chapter and the approved installation manual unless the department grants a deviation pursuant to 12VAC5-610-660 or the division has granted a deviation identified in the installation manual.

5. Gravelless material shall contain a pressure percolation line along the entire length of the trench when low pressure distribution is utilized pursuant to 12VAC5-610-940 D.

6. When pumping effluent to overcome gravity, any open-bottom gravelless material shall provide a high-flow splash plate at the inlet of the trench or other suitable method approved by the manufacturer to reduce effluent velocity.

7. When enhanced flow distribution is used, open-bottom gravelless material shall contain a percolation pipe that extends a minimum of 10 feet from the trench's intersection with the header line. The percolation pipe shall be installed in accordance with the manufacturer's approved installation manual. The dosing volume shall be a minimum 39 gallons per 100 linear feet of absorption trench.

8. Gravelless material may be substituted for gravel in accordance with this chapter, provided that the certifying licensed professional engineer or onsite soil evaluator approves the substitution. The certifying licensed professional engineer or onsite soil evaluator shall document the substitution and related design changes on the inspection report submitted in accordance with 12VAC5-610-330. A new construction permit pursuant to 12VAC5-610-310 is not required for the substitution.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.28, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000; Volume 32, Issue 24, eff. August 25, 2016; Volume 39, Issue 4, eff. November 24, 2022.

12VAC5-610-940 Low pressure distribution

Low pressure distribution is the conveyance of effluent through the pressure percolation lines at full flow conditions into the absorption area with the prime motive force being a pump or siphon. Low pressure systems are limited to a working pressure of from one to four feet of head at the distal end of the pressure percolation lines. For the purpose of this chapter low pressure distribution is considered to provide unsaturated soil conditions.

A. Dosing cycle. Systems shall be designed so that the effluent volume applied to the absorption area per dosing cycle is from seven to 10 times the volume of the distribution piping, however, the volume per dosing cycle should not result in a liquid depth in the absorption trench greater than two inches.

B. Manifold lines. Manifold lines are watertight lines that convey effluent from the initial point of flow splitting to the pressure percolation lines.

1. Size. The manifold line shall be sized to provide a minimum velocity of two feet per second and a maximum velocity of eight feet per second.

2. Materials. All pipe used for manifolds shall be of the pressure type with pressure type joints.

3. Bedding. All manifolds shall be bedded to supply uniform support along its length.

4. Backfilling and tamping. Manifold trenches shall be backfilled and tamped as soon as possible after the installation of the manifold has been approved. Material for backfilling shall be free of large stones and debris.

5. Valves. Valves for throttling and check valves to prevent backflow are required wherever necessary. Each valve shall be supplied with a valve box terminating at the surface.

C. Pressure percolation lines. Pressure percolation lines are perforated pipes utilized to distribute the flow evenly along the length of the absorption trench.

1. Size. Pressure percolation lines should normally have a 1-1/4 inch inside diameter.

2. Hole size. Normal hole size shall be 3/16 inch to 1/4 inch.

3. Hole placement. Center to center hole separation shall be between three and five feet.

4. Line length. Maximum line length from manifold should not exceed 50 feet.

5. Percent flow variation. Actual line size, hole size and hole separation shall be determined on a case-by-case basis based on a maximum flow variation of 10% along the length of the pressure percolation lines.

6. Materials and construction. The preferred material is plastic, either PVC or ABS, designed for pressure service. The lines shall have burr free and counter sunk holes (where possible) placed in a straight line along the longitudinal axis of the pipe. Joining of pipes shall be accomplished with manufactured pressure type joints.

7. Installation.

a. Crushed stone or gravel. Clean gravel or crushed stone having a size range from 1/2 inch to 3/4 inch shall be utilized to bed the pressure percolation lines. Minimum depth of gravel or crushed stone beneath the percolation lines shall be 8-1/2 inches. Clean course silica sand (does not effervesce in the presence of dilute hydrochloric acid) may be substituted for the first two inches (soil interface) of the required 8-1/2 inches of gravel beneath the pressure percolation lines. The absorption trench shall be backfilled to a depth of two inches over the pressure percolation lines with the same gravel or crushed stone. Clean sand, gravel or crushed stone shall be free of fines, clay and organic materials.

b. Grade boards or stakes. Grade boards or stakes placed in the bottom or sidewalls of the absorption trench shall be utilized to maintain the gravel level for placement of the pressure percolation lines. Grade stakes shall not be placed on centers greater than 10 feet.

c. Placement and alignment. Pressure percolation lines shall be placed so that the holes face vertically downward. All pressure percolation piping shall be placed at the same elevation, unless throttling valves are utilized, and shall be level. The piping shall be placed in the horizontal center of the trench and shall maintain a straight alignment. Normally the invert of the pressure percolation lines shall be placed 8-1/2 inches above the trench bottom. However, under no circumstance shall the invert of the pressure percolation lines be placed closer than 16-1/2 inches to the seasonal water table as defined in 12VAC5-610-470 D. When the invert of the pressure percolation lines must be placed at an elevation greater than 8-1/2 inches above the trench bottom, landscaping over the absorption area may be required to provide the two inches of gravel and six inches of fill over the pressure percolation lines required in subdivision 7 a of this subsection.

d. Backfilling. After the placement of the pressure percolation piping the absorption trench shall be backfilled evenly with crushed stone or gravel to a depth of two inches over the opening. Untreated building paper or other suitable material shall be placed at the interface of the gravel and soil to prevent migration of fines to the trench bottom. The remainder of the trench shall be backfilled with soil to the ground surface.

8. Appurtenances. The distal (terminal) end of each pressure percolation lines shall be fitted with a vertical riser and threaded cap extending to the ground surface. Systems requiring throttling valves will be supplied with couplings and threaded riser extensions at least four feet long so that the flow may be adjusted in each line.

D.Gravelless material with general approval may be used for low pressure distribution in accordance with the manufacturer's approved installation manual, Table 5.4 of 12VAC5-610-950, and the applicable requirements of this chapter.

History

• Statutory Authority: §§ 32.1-12, 32.1-164, and 32.1-164.9 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.29, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000; Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-610-950 Absorption area design

A. The absorption area is the undisturbed soil medium utilized for absorption of the effluent. The absorption area includes the infiltrative surface in the absorption trench and the soil between and around the trenches when trenches are used.

B. Suitability of soil horizon. The absorption trench bottom shall be placed in the soil horizon or horizons with an average estimated or measured percolation rate less than 120 minutes per inch. Soil horizons are to be identified in accordance with 12VAC5-610-480. The soil horizon must meet the following minimum conditions:

1. It shall have an estimated or measured percolation rate equal to or less than 120 minutes per inch;

2. The soil horizon or horizons shall be of sufficient thickness so that at least 12 inches of absorption trench sidewall is exposed to act as an infiltrative surface; and

3. If no single horizon meets the conditions in subdivision 2 of this subsection, a combination of adjacent horizons may be utilized to provide the required 12-inch sidewall infiltrative surface. However, no horizon utilized shall have an estimated or measured percolation rate greater than 120 minutes/inch.

C. Placement of absorption trenches below soil restrictions. Placement of the soil absorption trench bottom below soil restrictions as defined in 12VAC5-610-490 D, whether or not there is evidence of a perched water table as indicated by free standing water or redoximorphic features, including concentrations, depletions, or stains, nodules, or concretions of iron and manganese, requires a special design based on the following criteria:

1. The soil horizon into which the absorption trench bottom is placed shall be a Texture Group I, II, or III soil or have an estimated or measured percolation rate of less than 91 minutes per inch.

2. The soil horizon shall be a minimum of three feet thick and shall exhibit no characteristics that indicate wetness on restriction of water movement. The absorption trench bottom shall be placed so that at least two feet of the soil horizon separates the trench bottom from the water table or rock. At least one foot of the absorption trench side wall shall penetrate the soil horizon.

3. A lateral ground water movement interceptor (LGMI) shall be placed upslope of the absorption area. The LGMI shall be placed perpendicular to the general slope of the land. The invert of the LGMI shall extend into, but not through, the restriction and shall extend for a distance of 10 feet on both sides of the absorption area (See 12VAC5-610-700 D 3).

4. Pits shall be constructed to facilitate soil evaluations as necessary.

D. Sizing of absorption trench area for septic tank effluent.

1. Required area. The total absorption trench bottom area required shall be based on the average estimated or measured percolation rate for the soil horizon or horizons into which the absorption trench is to be placed. If more than one soil horizon is utilized to meet the sidewall infiltrative surface required in subsection B of this section, the absorption trench bottom area shall be based on the average estimated or measured percolation rate of the "slowest" horizon. The trench bottom area required in square feet per 100 gallons (Ft²/100 Gals) of sewage applied for various soil percolation rates is tabulated in Table 5.4. The area requirements are based on the equation:

log y = 2.00 + 0.008 (x)

where y = Ft²/100 Gals

x = Percolation rate in minutes/inch

Notwithstanding the above, the minimum absorption area for single family residential dwellings shall be 400 square feet.

2. Area reduction. See Table 5.4 for area reduction when gravelless material or low pressure distribution is utilized. A reduction in area shall not be permitted when flow diversion is utilized with low pressure distribution. When gravelless material is utilized, the design width of the trench shall be used to calculate minimum area requirements for absorption trenches.

E. Minimum cross section dimensions for absorption trenches.

1. Depth. The minimum trench sidewall depth as measured from the surface of the mineral soil shall be 12 inches when placed in a landscape with a slope less than 10%. The installation depth shall be measured on the downhill side of the absorption trench. When the installation depth is less than 18 inches, the depth shall be measured from the lowest elevation in the microtopography. All systems shall be provided with at least 12 inches of cover to prevent frost penetration and provide physical protection to the absorption trench; however, this requirement for additional cover shall not apply to systems installed on slopes of 30% or greater. Where additional soil cover must be provided to meet this minimum, it must be added prior to construction of the absorption field, and it must be crowned to provide positive drainage away from the absorption field. The minimum trench depth shall be increased by at least five inches for every 10% increase in slope. Sidewall depth is measured from the ground surface on the downhill side of the trench.

2. Width. All absorption trenches utilized with gravity distribution shall have a width of from 18 inches to 36 inches. All absorption trenches utilized with low pressure distribution shall have a width of eight inches to 24 inches.

F. Lateral separation of absorption trenches. The absorption trenches shall be separated by a center to center distance no less than three times the width of the trench for slopes up to 10%. However, where trench bottoms are two feet or more above rock, pans, and impervious strata, the absorption trenches shall be separated by a center to center distance no less than three times the width of the trench for slopes up to 20%. The minimum horizontal separation distance shall be increased by one foot for every 10% increase in slope. In no case shall the center to center distance be less than 30 inches.

G. Slope of absorption trench bottoms.

1. Gravity distribution. The bottom of each absorption trench shall have a uniform slope not less than two inches or more than four inches per 100 feet.

2. Low pressure distribution. The bottom of each absorption trench shall be uniformly level to prevent ponding of effluent.

H. Placement of absorption trenches in the landscape.

1. The absorption trenches shall be placed on contour.

2. When the ground surface in the area over the absorption trenches is at a higher elevation than any plumbing fixture or fixtures, sewage from the plumbing fixture or fixtures shall be pumped.

I. Lateral ground water movement interceptors. Where subsurface, laterally moving water is expected to adversely affect an absorption system, a lateral ground water movement interceptor (LGMI) shall be placed upslope of the absorption area. The LGMI shall be placed perpendicular to the general slope of the land. The invert of the LGMI shall extend into, but not through, the restriction and shall extend for a distance of 10 feet on either side of the absorption area.

| Table 5.4. Area Requirements for Absorption Trenches Receiving Septic Tank Effluent. | | | | | | | | --- | --- | --- | --- | --- | --- | --- | | Percolation Rate (Minutes/Inch) | Area Required (Ft²/100 Gals) | Area Required (Ft²/Bedroom) | | | | | | Gravity | Gravity Gravelless | Low Pressure Distribution | Gravity | Gravity Gravelless | Low Pressure Distribution | | | 5 | 110 | 83 | 110 | 165 | 124 | 165 | | 10 | 120 | 90 | 120 | 180 | 135 | 180 | | 15 | 132 | 99 | 132 | 198 | 149 | 198 | | 20 | 146 | 110 | 146 | 218 | 164 | 218 | | 25 | 158 | 119 | 158 | 237 | 178 | 237 | | 30 | 174 | 131 | 164 | 260 | 195 | 255 | | 35 | 191 | 143 | 170 | 286 | 215 | 260 | | 40 | 209 | 157 | 176 | 314 | 236 | 264 | | 45 | 229 | 172 | 185 | 344 | 258 | 279 | | 50 | 251 | 188 | 193 | 376 | 282 | 293 | | 55 | 275 | 206 | 206 | 412 | 309 | 309 | | 60 | 302 | 227 | 217 | 452 | 339 | 325 | | 65 | 331 | 248 | 228 | 496 | 372 | 342 | | 70 | 363 | 272 | 240 | 544 | 408 | 359 | | 75 | 398 | 299 | 251 | 596 | 447 | 375 | | 80 | 437 | 328 | 262 | 656 | 492 | 394 | | 85 | 479 | 359 | 273 | 718 | 539 | 409 | | 90 | 525 | 394 | 284 | 786 | 590 | 424 | | 95 | 575 | 489 | 288 | 862 | 733 | 431 | | 100 | 631 | 536 | 316 | 946 | 804 | 473 | | 105 | 692 | 588 | 346 | 1038 | 882 | 519 | | 110 | 759 | 645 | 379 | 1138 | 967 | 569 | | 115 | 832 | 707 | 416 | 1248 | 1061 | 624 | | 120 | 912 | 775 | 456 | 1368 | 1163 | 684 |

J. Controlled blasting. When rock or rock outcroppings are encountered during construction of absorption trenches the rock may be removed by blasting in a sequential manner from the top to remove the rock. Percolation piping and sewer lines shall be placed so that at least one foot of compacted clay soil lies beneath and on each side of the pipe where the pipe passes through the area blasted. The area blasted shall not be considered as part of the required absorption area.

K. Trenches receiving TL-2 effluent or TL-3 effluent are exempt from the increase in trench depth with slope and the soil cover requirements as found in 12VAC5-610-950 E. The following additional requirements shall apply.

1. Soil dispersal loading rates shall not exceed the values in Table 5.5.

2. The minimum vertical separation to a limiting feature shall be maintained under the entire infiltrative surface in accordance with 12VAC5-613-80.

3. The minimum soil cover, after settling, shall be six inches as measured from the finished ground surface to the uppermost limit of the dispersal media (or gravelless material) utilized in the absorption area. On sloping sites, cover shall be tied back into the existing slope to facilitate stabilization of the slope and maintenance of the site. The soil cover, with amendments as needed, shall be of a quality, character, and fertility suitable to establish a vegetative cover that is uniform and sufficiently mature to survive and inhibit erosion.

4. The minimum installation depth is equal to the sidewall of the dispersal system construction as described in 12VAC5-610-930 F (gravelless), 12VAC5-610-940, and subdivision E 1 of this section. On sloping sites, the minimum installation depth is measured on the downhill side of the absorption trench.

5. When trenches are installed at less than 12 inches from the ground surface, timed dosing shall be used to disperse the effluent.

6. For slopes up to 15% slope, there are not any soil texture group limitations for shallow placed trenches receiving TL-2 effluent or TL-3 effluent. For slopes over 15%, trench systems installed in Texture Group III and IV soils shall have a 12-inch or greater installation depth.

7. Designs supported by division-approved manufacturer design manuals may deviate from subdivisions K 4 and K 5 of this section.

8. Notwithstanding subdivisions K 1 through K 7 of this section, the minimum absorption area for a single-family residential dwelling receiving TL-2 effluent or TL-3 effluent shall be 400 square feet.

| Table 5.5 Soil Absorption Area Loading Rates for Systems Receiving TL-2 Effluent or TL-3 Effluent | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Percolation Rate (mpi) | TL-2 Effluent | TL-3 Effluent | | | | | | | | | Pressure Trench* Loading (gpd/ft²) | Gravity Trench* Loading (gpd/ft²) | Drip** Loading) (gpd/ft²) | Pad/Mound Loading** (gpd/ft²) | Pressure Trench* Loading (gpd/ft²) | Gravity Trench* Loading (gpd/ft²) | Drip** Loading (gpd/ft²) | Pad/Mound Loading** (gpd/ft²) | | | | | | | | | | | | | | | | | | | | | | | | | | 5 | 1.8 | 1.80 | 0.60 | 1.20 | 3.0 | 3.00 | 1.00 | 1.66 | | | 10 | 1.67 | 1.67 | 0.56 | 1.11 | 2.67 | 2.67 | 0.89 | 1.66 | | | 15 | 1.53 | 1.53 | 0.51 | 1.02 | 2.33 | 2.33 | 0.78 | 1.66 | | | 20 | 1.4 | 1.40 | 0.47 | 0.93 | 2.0 | 2.00 | 0.67 | 1.66 | | | 25 | 1.30 | 1.30 | 0.43 | 0.86 | 1.75 | 1.75 | 0.58 | 1.33 | | | 30 | 1.2 | 1.13 | 0.40 | 0.80 | 1.5 | 1.41 | 0.50 | 1.11 | | | 35 | 1.10 | 0.98 | 0.37 | 0.73 | 1.38 | 1.22 | 0.46 | 0.95 | | | 40 | 1.00 | 0.84 | 0.33 | 0.66 | 1.25 | 1.05 | 0.42 | 0.83 | | | 45 | 0.90 | 0.73 | 0.30 | 0.60 | 1.13 | 0.91 | 0.38 | 0.74 | | | 50 | 0.8 | 0.62 | 0.27 | 0.53 | 1.0 | 0.77 | 0.33 | 0.67 | | | 55 | 0.76 | 0.57 | 0.25 | 0.50 | 0.94 | 0.71 | 0.31 | 0.61 | | | 60 | 0.71 | 0.51 | 0.24 | 0.47 | 0.89 | 0.64 | 0.30 | 0.55 | | | 65 | 0.67 | 0.46 | 0.22 | 0.44 | 0.83 | 0.57 | 0.28 | 0.51 | | | 70 | 0.62 | 0.41 | 0.21 | 0.41 | 0.78 | 0.51 | 0.26 | 0.48 | | | 75 | 0.58 | 0.36 | 0.19 | 0.38 | 0.72 | 0.46 | 0.24 | 0.44 | | | 80 | 0.53 | 0.32 | 0.18 | 0.35 | 0.67 | 0.40 | 0.22 | 0.42 | | | 85 | 0.49 | 0.28 | 0.16 | 0.33 | 0.61 | 0.35 | 0.20 | 0.39 | | | 90 | 0.44 | 0.24 | 0.15 | 0.30 | 0.56 | 0.30 | 0.19 | 0.37 | | | 95 | 0.4 | 0.20 | 0.13 | 0.27 | 0.5 | 0.25 | 0.17 | 0.35 | | | 100 | 0.37 | 0.19 | 0.12 | 0.25 | 0.46 | 0.23 | 0.15 | 0.33 | | | 105 | 0.34 | 0.17 | 0.11 | 0.23 | 0.43 | 0.21 | 0.14 | 0.32 | | | 110 | 0.31 | 0.16 | 0.10 | 0.21 | 0.39 | 0.19 | 0.13 | 0.30 | | | 115 | 0.28 | 0.14 | 0.09 | 0.19 | 0.35 | 0.18 | 0.12 | 0.29 | | | 120 | 0.25 | 0.13 | 0.08 | 0.17 | 0.32 | 0.16 | 0.11 | 0.28 | | | *Loading rates to trenches, whether gravity or pressure dosed, are based on the gallons per day of wastewater applied to the bottom of the trench. **Loading rates to drip systems, pads, and mounds are based on the infiltrative surface area provided and are on an aerial basis. | | | | | | | | | |

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.29, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000; Volume 32, Issue 24, eff. August 25, 2016; Volume 39, Issue 4, eff. November 24, 2022.

12VAC5-610-955 Drip dispersal

A. Drip dispersal applies wastewater in an even and controlled manner over an absorption area. Drip dispersal system components may include treatment components, a flow equalization pump tank, a filtration system, a flow measurement method, supply and return piping, small diameter pipe with emitters, air/vacuum release valves, redistribution control, and electromechanical components or controls.

B. Drip dispersal system tubing shall be color coded and certified by the manufacturer as designed and manufactured for the dispersal of wastewater. All drip dispersal system tubing shall be equipped with emitters approved for use with wastewater. For the application of septic tank effluent, the tubing must have self-cleaning emitters.

1. The minimum linear feet of tubing in the system shall be one-half of the minimum soil absorption area in square feet.

2. All tubing shall be placed on contour.

3. Except as provided by 12VAC5-613, drip systems dispersing septic tank effluent shall comply with the requirements of 12VAC5-610-594.

4. Drip systems dispersing secondary effluent or better require a minimum of six inches of cover over the tubing. Cover may be achieved by a combination of installation depth and Group II or Group III soil cover or other approved material over the drip field.

5. The discharge rate of any two emitters shall not vary by more than 10% in order to ensure that the effluent is uniformly distributed over the entire drip field or zone.

6. The emitters shall be evenly spaced along the length of the drip tubing at not less than six inches or more than 24 inches apart.

7. The system design shall protect the drip emitters and system from the effects of siphoning or backflow through the emitters.

C. Drip dispersal systems shall comply with the following minimum soil absorption area requirements:

1. For the dispersal of septic tank effluent, the minimum soil absorption area for a drip system shall be calculated by multiplying the trench bottom area required for a low pressure distribution system in Table 5.4 of 12VAC5-610-950 by three.

2. For the dispersal of TL-2 effluent or TL-3 effluent, the minimum soil absorption area shall be in accordance with Table 5.5 of 12VAC5-610-950.

3. Air/vacuum release valves shall be located at the high points of the supply and return manifolds to each zone.

D. All drip dispersal systems shall be equipped with devices or methods to restrict effluent from draining by gravity to portions of a zone or laterals lower in elevation. Variable distribution due to gravity drainage shall be 10% or less within a zone.

E. A minimum of six hours of emergency storage above the high water alarm in the pump chamber shall be provided. The equalization volume shall be equal to 18 hours of storage. The equalization volume shall be measured from the pump off level to the high water alarm level. An audio/visual alarm meeting the requirements of 12VAC5-610-880 B 8 shall be provided for the pump chamber.

F. Each drip dispersal zone shall be time-dosed over a 24-hour period. The dose volume and interval shall be set to provide unsaturated flow conditions. Demand dosing is prohibited. Minimum dose volume per zone shall be 3.5 times the liquid capacity of the drip laterals in the zone plus the liquid capacity of the supply and return manifold lines (which drain between doses) accounting for instantaneous loading and drain back.

1. At each dosing cycle, the system design shall only allow a full dose volume to be delivered.

2. For design flows greater than 1,000 gallons per day, a means to take each zone off line separately shall be provided. The system shall have the capability to bypass each zone that is taken out of service such that each subsequent dose is dispersed to the next available zone in sequence.

G. Filtration shall be provided to remove suspended solids and prevent clogging of emitters. The filtration design shall meet the drip tubing manufacturer's particle size requirements for protection of the emitters at a flow rate equal to or greater than the rate of forward flushing. Filter flush water shall be returned to the treatment system at a point where the residuals and volume of the flush water do not negatively impact the effluent quality or exceed the hydraulic design capacity of the treatment system.

H. A means for measuring or estimating total flow dispersed to the soil absorption area and to verify field dosing and field flushing rates shall be provided.

I. The system shall provide forward field flushing to achieve scouring velocity as specified by the drip tubing manufacturer. Field flushing shall occur on a routine schedule to prevent excessive solids accumulation and clogging. Flush water shall be returned to the treatment system at a point where the residuals and volume of the flush water do not negatively impact the effluent quality or exceed the hydraulic design capacity of the treatment system.

J. Electrical components shall be Underwriters Laboratory (UL) listed for the intended purpose. The designer shall provide a description with a schematic diagram of the electrical and control functions in the operation and maintenance manual. The electrical control equipment shall be mounted within a National Electrical Manufacturers Association (NEMA) 4X rated enclosure with a rigid latching door. All switches shall be clearly identified, and all internal wiring shall be factory installed. All wiring shall be installed according to applicable electrical safety codes and the manufacturer's installation schematic.

K. All components in a drip dispersal system shall be rated to withstand contact with wastewater and recommended for this application by the manufacturer. All components shall be protected from freezing.

L. The designer of the drip dispersal system shall verify the dosing rates, the flushing rates, and other parameters critical to the proper operation of the system at the startup inspection. A summary of the startup inspection shall be included in the operation and maintenance manual and shall include, at a minimum, the dosing volume, the forward flow flushing rate, the pressure head of the system, and verification of proper cycling between zones.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016; amended, Virginia Register Volume 39, Issue 4, eff. November 24, 2022.

12VAC5-610-960 Elevated sand mound

A. An elevated sand mound is a soil absorption system that incorporates low pressure distribution and sand filtration to produce treated sewage prior to absorption in the natural underlying soil. The elevated sand mound utilizes less gross soil area than most other soil absorption systems. Elevated sand mounds differ from pads in that elevated sand mounds are always an aboveground system, may receive septic tank effluent, and always require pressure distribution, and the infiltrative surface follows the natural ground surface and contour of the site.

B. Mound systems receiving septic tank effluent shall be designed and constructed in accordance with the Wisconsin Mound Soil Absorption System Siting, Design and Construction Manual prepared by the Small Scale Waste Management Project, School of Natural Resources, College of Agricultural and Life Sciences, University of Wisconsin-Madison dated January 2000. Drip dispersal or low pressure distribution shall be used.

C. The manual referred to in subsection B of this section shall be used for the designated construction of elevated sand mounds. The following criteria are required for all elevated sand mound systems in addition to the requirements found in the manual.

1. The proposed mound site shall be fenced, roped, or otherwise secured, and marked, to prevent damage by vehicular traffic. Activities on the mound site shall be severely limited in order to protect it to the greatest extent possible.

2. The mound must be constructed during dry weather and soil conditions.

3. Wooded sites shall not be used unless it is shown by the applicant that the wooded site is the only site available, and if the applicant can demonstrate that the site can be properly prepared. If a wooded site is used, trees shall be removed by cutting them off at ground level, leaving the stumps in place. The cut trees shall be removed using methods that do not require driving equipment over the mound site and that do not result in the removal of any soil from the site. Larger basal areas may be required on wooded sites.

4. When the depth to a restriction, shrink-swell soils, or a water table is less than 24 inches, pretreatment sufficient to produce TL-2 effluent or TL-3 effluent may be used to reduce these distances in accordance with 12VAC5-613-80.

5. The minimum absorption area for single family residential dwellings shall be 400 square feet.

D. Elevated sand mounds receiving TL-2 effluent or TL-3 effluent shall adhere to the following additional design criteria.

1. The basal area (interface of fill sand and original soil surface) loading rate shall not exceed the values found in Table 5.5.

2. The minimum sand depth under the dispersal system is six inches.

3. The minimum soil cover, after settling, shall be six inches as measured from the finished ground surface to the uppermost limit of the dispersal media (or gravelless material) utilized in the absorption area. The finished sideslopes cannot exceed 1:4 (rise:run). The soil cover, with amendments as needed, shall be of a quality, character, and fertility suitable to establish a vegetative cover that is uniform and sufficiently mature to survive and inhibit erosion.

4. Vertical separation to limiting features as found in 12VAC5-613-80 shall be maintained under the entire infiltrative surface of the basal area.

5. Designs supported by division approved manufacturer design manuals may deviate from pressure dosing but require dosing to a gravity distribution system at a minimum.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.31, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000; Volume 39, Issue 4, eff. November 24, 2022; Errata, 39:6 VA.R. 985 November 7, 2022.

12VAC5-610-965 Sand-on-sand

A. Sand-on-sand is a process of modifying a soil absorption system site using fill material which is similar in texture to the original, naturally occurring material. Filling is accomplished in a manner which allows for adequate treatment and disposal of effluent, protection from frost and traffic damage, and does not promote the creation of restrictive horizons. Sand-on-sand systems are considered Type II systems and are used to overcome limitations encountered with certain high water table soils. A detailed description of the siting criteria used for sand-on-sand systems is found in 12VAC5-610-597.

B. Site preparation. All surface vegetation and organic matter, including but not limited to grass, shrubs, trees, leaf litter, branches, limbs, and tree stumps shall be removed. Special consideration shall be given to site preparation to avoid soil compaction and other damage which may create discontinuities and restrictive horizons when the fill material is placed on the site.

C. Fill material. Fill material may be added to such a site and used for residential onsite wastewater disposal for flows up to 1,000 G.P.D. on sites meeting the criteria established in 12VAC5-610-597 provided that:

1. The fill material used is the same texture as the underlying material;

2. The coarse fragment content of the fill material is neither greater than 10% by volume nor noncarbonaceous and inorganic material greater than two mm in size;

3. The fill material is placed in such a manner as to prevent the formation of any restrictive horizons;

4. The fill material covers an area 10 feet greater in all horizontal dimensions than the soil absorption system;

5. The sides of the filled area are sloped at not greater than 1:10 (rise:run);

6. The fill material provides at least six inches of cover over all portions of the system; and

7. The fill material is stabilized to prevent surface erosion.

D. Application rate. All sand-on-sand systems shall be designed on a 30 mpi loading rate and shall use a method of pressure distribution which achieves unsaturated flow conditions.

E. Fill depth. All sand-on-sand systems utilizing gravel trench designs shall have a minimum of 25 inches of fill over the original site.

F. System placement. The drainfield trenches shall be placed so that there is six inches of fill, or more, beneath the trench bottom and six inches of fill over the trenches.

G. The remaining design and construction criteria for sand-on-sand systems are the same as for the design and construction of a similar system in original undisturbed soils.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-966 Pads

A. A pad is an absorption area wider than three feet but not longer than 100 feet with a level infiltrative surface where the bottom of the pad meets the original soil. The minimum standoff to a limiting feature in accordance with 12VAC5-613-80 is to be met under the entire infiltrative surface.

B. The minimum effluent quality dispersed to a pad is TL-2 effluent and pad bottom loading rates shall not exceed the values for pads noted in Table 5.5 of 12VAC5-610-950.

C. The longest dimension of the basal area of the pad, its length, shall be oriented parallel to the natural surface topographic contours. Minor deviations from surface contours are acceptable as long as the bottom of the pad is level (the entire bottom surface of the pad is at the same elevation, not to exceed 10% of the depth of the pad from the ground surface or plus or minus two inches, whichever is less), and intersects a similar soil horizon across its surface.

D. Pads and trenches may be used together in a single system when the respective pad or trench subsystems follow the respective design criteria found in this chapter and are separated by a minimum of six feet between the sidewall of the pad and the trench. When multiple pads are used on a site, the pads must be separated by the width of the pad as measured perpendicular to the natural surface topographic contour.

E. Pads shall be limited to sites with slopes of 10% or less (less than or equal to 10 feet of rise for every 100 feet of run).

F. All pads must be dosed. Pad systems over 1,000 gallons per day must be pressure dosed. When pads are installed at less than 12 inches from the ground surface, timed dosing shall be used to disperse the effluent.

G. The minimum absorption area for single family residential dwellings shall be 400 square feet.

H. Pad construction.

1. Gravel pads shall have a minimum installation depth of 12 inches, unless in Texture Group I or II soils where the installation depth can be reduced to eight inches. On sloping sites, the minimum installation depth is measured on the downhill side of the pad infiltrative surface. The construction of the pad's gravity percolation line and gravel bedding shall follow 12VAC5-610-930 E with the exception that the bottom of the pad is level and not sloping. Piping shall have a maximum center to center spacing of nine feet.

2. Gravel pads utilizing low pressure distribution shall follow 12VAC5-610-940 for construction and dosing cycle (volume). Gravel pads using low pressure distribution shall have a minimum installation depth of 12 inches, unless in Texture Group I or II soils where the installation depth can be reduced to eight inches. On sloping sites, the minimum installation depth is measured on the downhill side of the pad infiltrative surface. Piping shall have a maximum center to center spacing of nine feet.

3. Pads utilizing gravelless material as found in 12VAC5-610-930 F shall follow 12VAC5-610-930 F and manufacturer instructions on minimum depth of installation, but in no case shall a pad be installed at less than eight inches from the original soil surface. Gravelless material shall have a maximum center to center spacing of nine feet. On sloping sites, the minimum installation depth is measured on the downhill side of the pad infiltrative surface.

4. Designs supported by a division approved manufacturer's design manual may deviate from the maximum slope, depth of installation, separation distance between pads, and timed dosing when the dispersal area is constructed in accordance with the approved manual.

I. The minimum soil cover, after settling, shall be six inches as measured from the finished ground surface to the uppermost limit of the dispersal media (or gravelless material) utilized in the absorption area. If the cover is mounded above grade, the finished sideslope cannot exceed 1:4 (rise:run). The soil cover, with amendments as needed, shall be of a quality, character, and fertility suitable to establish a vegetative cover that is uniform and sufficiently mature to survive and inhibit erosion.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 4, eff. November 24, 2022.

Article 6 Privies

12VAC5-610-970 General

A privy is a nonwater carriage device for temporary storage or permanent disposal of human excreta. The privy shall not be used as the receptacle of any water carriage wastes.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.32, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-980 Types

A. Privies are divided into two categories, those that function as disposal facilities and those that function merely as holding facilities with ultimate disposal of the contents at another facility via pump and haul.

B. Disposal privies.

1. Pit privy.

a. Description. A pit privy consists of a lined earthen pit with a suitable rodent and insect proof structure and pit vent stack. The structure shall be provided with self-closing lid or lids on the seat riser. The pit privy is located exterior to a dwelling.

b. Location. Required separation distances from various structures and topographic features are the same as for subsurface soil absorption systems and may be found in Table 4.2. The bottom of the pit privy shall be at least two feet above the seasonal water table and any rock. Location of pit privies shall also comply with 12VAC5-610-593 1 through 6 and 10.

c. Utilization. The Uniform Statewide Building Code of Virginia normally prohibits the installation of pit privies at new homes. In case of hardship, unsuitable soil conditions or temporary recreational use, a privy can sometimes be constructed after obtaining the approval of the building official with the approval of the department. A sewage disposal system meeting the requirements of 12VAC5-610-250 A and B shall be provided to treat other sewage (wastewater) generated from activities such as laundering, bathing, handwashing, and cooking. Pit privies utilized at existing dwellings should be abandoned within one year of the availability of sanitary sewers. Proper abandonment consists of removing the structure and covering the pit with at least two feet of soil. Pit privies are an acceptable means of sewage disposal at isolated areas such as primitive camping areas, public boat launching areas, recreation areas, state parks and wilderness areas where pressurized water systems are not provided.

2. Incinerator toilets.

a. Description. Incinerator toilets are devices that utilize electrical energy or burning gas to incinerate human excreta deposited directly into them. They function both as toilet and disposal facility and produce an inert ash. Incinerator toilets are located in the interior of a dwelling.

b. Utilization. In addition to the conditions stated in subdivision 1 c of this subsection for pit privies, incinerator toilets shall not be utilized where they are subjected to frequent use and/or peak loading conditions.

c. Certification. All incinerator toilets must be certified by the National Sanitation Foundation as meeting the current Standard 41.

3. Composting toilets.

a. Description. Composting toilets are devices which incorporate an incline plane, baffles or other suitable devices onto which human excreta is deposited for the purpose of allowing aerobic decomposition of the excreta. The decomposing material is allowed to accumulate to form a humus type material. These units serve as both toilet and disposal devices. Composting toilets are located interior to a dwelling.

b. Utilization. In addition to the conditions stated in subdivision 1 c of this subsection for pit privies, all materials removed from a composting privy shall be buried. Compost material shall not be placed in vegetable gardens or on the ground surface.

c. Certification. All composting toilets must be certified by the National Sanitation Foundation as meeting the current Standard 41.

C. Holding privies.

1. General. Due to the nature of these devices, i.e., they require routine pump and haul, special care shall be taken in selecting these devices for use. These devices are satisfactory for use at mass gatherings, transient worker populations, construction sites, recreation areas, etc.

2. Vault privy.

a. Description. A vault privy is similar to a pit privy except that, instead of an earthen pit, a water and corrosion proof containment vessel (vault) is provided. The vault shall be provided with access for periodic removal of the vault contents.

b. Location. Vault privies shall be located to prevent contamination of ground water or surface water. The elevation of the top of the vault or access port shall be placed two feet above the annual flood elevation. Separation distances from structures and topographic features will be determined on a case-by-case basis.

c. Utilization. Vault privies are an acceptable method of holding human excreta where ground water, surface water or other conditions prohibit the installation of other approved sewerage facilities. The conditions contained in subdivision B 1 c of this section shall be met.

3. Portable privies.

a. Description. A portable privy is a type of vault privy that is generally manufactured as a single unit and is easily transported.

b. Location. Location of portable privies should be determined on a case-by-case basis under the supervision of the district or local health department.

c. Utilization. Portable privies are normally used in association with mass gatherings, construction sites, etc., where temporary facilities are required.

d. Numbers required.

(1) When portable privies are used at mass gatherings, one privy per 100 persons shall be provided as a minimum.

(2) When portable privies are used at construction sites or transient worker locations, one privy per 25 persons shall be provided as a minimum.

e. Pumping. The containment vessel of the portable privies shall be pumped as often as necessary to prevent overflow. It is recommended that they be pumped when 2/3 full.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.33, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

Article 7 Storage Facilities Criteria for Pump and Haul of Sewage

12VAC5-610-990 General

Storage facilities associated with pump and haul operations permitted under 12VAC5-610-420 shall meet the criteria contained herein.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.34, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-1000 Location

The storage facilities shall be accessible by an all weather road of suitable carrying capacity to handle a fully loaded tank truck. Sufficient all weather surface area with appropriate carrying capacity shall be provided for maneuvering the tank truck.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.35, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-1010 Design

A. Capacity. Temporary storage facilities shall have sufficient capacity to store the projected flow for 48 hours.

B. Materials. The materials utilized shall be resistant to the corrosive action of sewage and shall be capable of withstanding the internal and external loads placed upon it.

C. Watertightness. The storage facility shall be watertight.

D. Access. The storage facility shall be easily accessible for the removal of the sewage. An access manhole with minimum dimensions of 18 inches by 18 inches terminating at or above the ground surface shall be provided. The storage facility shall be a closed containment vessel and all access ports shall be provided with removable covers.

E. Venting. Adequate venting shall be provided in all storage facilities.

F. Level Alarm. All facilities shall be provided with an audiovisual alarm to be activated when the storage facility is 3/4 full. Audiovisual alarms shall alarm at two locations, one that is manned 24 hours per day and the other at the site of the storage facility where the storage facility receives sewage on a 24-hour basis. When sewage flow is intermittent only one alarm at the storage facility is required.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.36, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

Article 8 Vehicle Specifications for Sewage Handling

12VAC5-610-1020 General

All vehicles utilized to transport sewage shall be kept in a clean and sanitary condition.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.37, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-1030 Vehicle identification

The name and address of the owner shall be displayed on each side of the vehicle in letters at least four inches high. In addition, the sewage handling permit number shall be displayed immediately beneath the owners name and address and in plain sight.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.38, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-1040 Sewage containment vessel (tank)

The tank in which the sewage is to be transported shall be fully enclosed and watertight. All inlets and outlets to the tank shall be secured and made watertight during transit. The tank shall be secured to the truck.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.39, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-1050 Pumps

When a pump is utilized to transfer sewage, the pump shall be watertight and properly valved and/or capped to prevent spillage during transport.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.40, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-1060 Valves

All valves shall be watertight.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.41, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-1070 Hoses

Suction and discharge hoses shall be watertight and provisions shall be made for carrying the hose in a manner to prevent leakage.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.42, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

Article 9 Special Facilities

12VAC5-610-1080 Anaerobic lagooning of septage

A. General. An anaerobic lagoon for the purpose of this chapter is a nondischarging facility consisting of an open impervious structure, constructed of earth or other material specifically designed for receiving and stabilizing septage and other sewage sludges. Industrial waste sludges and sludges containing toxic material shall not be placed in these lagoons.

B. General site requirements.

1. Engineering, geologic, soil and hydrologic evaluation. Geologic information required by the district or local health department and the division shall include, but not be limited to, soil characteristics, percolation information, maximum ground water table, direction of ground water movement and permeability.

2. Location.

a. Minimum setback distances for topographic features are the same as those for subsurface soil absorption systems and are contained in Table 4.2.

b. Buffer zone. Buffer zone criteria are contained in Appendix I.

c. Flood protection. The anaerobic lagoon and operational components shall be located at an elevation which is not subject to the 100-year flood/wave action or shall otherwise be adequately protected against the 100-year flood/wave action damage. The anaerobic lagoon shall remain fully operational during the 25-year flood/wave action.

d. Surface runoff. Adequate provisions shall be made to divert storm water around the anaerobic lagoon and otherwise protect the lagoon's embankments.

3. Access. An all weather access road shall be provided.

4. Fencing. The facility site to include treatment units and appurtenances shall be fenced with a five foot fence (woven wire plus barbed wire); gates and locks to provide controlled entry into the facility. The fence shall be posted with signs identifying the facility, safety and health dangers and trespass penalties. The fence shall not be constructed closer than 10 feet to the outside edge of any treatment unit or appurtenance.

C. Design requirements (see Figure V-1 for typical sections).

1. Receiving facilities.

a. An impervious pad or sufficient strength to support a loaded tank truck and with drainage to the lagoon shall be provided at the point or points where the contents of the tank truck is offloaded into the lagoon or receiving facilities.

b. The receiving and inlet facilities shall be designed to transport the septage into the lagoon, to distribute the septage as evenly as possible throughout the lagoon and to minimize generation of odors and suspension of solids.

2. Treatment units.

a. Anaerobic lagoons.

(1) Number and capacity. A minimum of two lagoons shall be provided. The combined total capacity of the lagoons shall provide eight months storage based on the average daily discharge into the lagoon.

(2) Operating depth. The normal operating depth shall be from three to five feet.

(3) Lagoon bottom. The lagoon bottom shall be level, constructed of impervious material (10^%686 sm/sec) and be a minimum of two feet above the seasonal water table or at the original ground surface.

(4) Lagoon embankments. Embankments and/or dike walls shall be impervious and structurally stable. They shall be designed to permit access of equipment by appropriate lining or internal barriers necessary for sludge removal in a nuisance free and safe manner, and to minimize risk, supervision, operation and maintenance. Earthen embankments shall be sloped (minimum 1:3) and seeded with proper cover, subject to soil characteristics, to minimize erosion.

(5) Freeboard. A minimum freeboard of two feet above the normal depth shall be provided.

(6) Shape. A uniform shape shall be provided, i.e., round, square, or rectangular with no narrow or elongated portions. The lagoon shall not contain islands, peninsulas or coves unless they are part of the inlet/outlet design.

b. Sludge dewatering. When sludge dewatering units are provided they shall be designed in accordance with 12VAC5-580-700, Sludge Dewatering, Virginia Sewerage Regulations.

3. Supernatant disposal. Normally the lagoon supernatant should be included in the sludge mixed liquor which is disposed of on the land. When a system is designed to provide for separate supplemental supernatant disposal it shall be by subsurface soil absorption system. The minimum subsurface soil absorption system field size shall be based on the anticipated average daily supernatant generation rate and shall meet all applicable criteria contained in Article 1 (12VAC5-610-450 et seq.) of Part III and Article 5 (12VAC5-610-900) of this part. The lagoon outlet shall be designed to minimize the solids content of the supernatant withdrawn for disposal in the subsurface soil absorption system and shall be provided with a means to control the rate and quantity of supernatant withdrawal.

V0110040.JPG, SIZE-38 PICAS, TYPE-DPI

For Anaerobic lagooning of septage, see Virginia Administrative Code print product.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.43, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-1090 Lime stabilization of septage

A. General. Lime stabilization of septage is a process consisting of the addition of hydrated lime in sufficient quantity usually 50 pounds per 1000 gallons, to raise the pH and hold it at 12 or higher for at least 30 minutes before dewatering or land spreading. The process normally requires mixing during the lime addition process as well as a mixing tank to facilitate the holding and mixing requirement.

B. Mixing equipment.

1. Mixing may be accomplished by recirculation through the pump truck. Mixing through the pump truck is limited to operations where no more than one load at a time is processed. In this case a mixing tank is not required.

2. When a mixing tank is required a minimum capacity of 2000 gallons shall be provided. Mixing tank volume in excess of 2000 gallons may be required on a case-by-case basis. When separate mixing capability is necessary it may be accomplished by either mechanical mixing or air diffusion.

a. Mechanical mixers shall be capable of maintaining the bulk fluid velocity above 26 ft/minute and an impeller Reynolds number greater than 1000.

b. Diffused air requirements range from 150 to 250 CFM/1000 Ft of tank volume for course bubble diffusers. The diffusers shall be mounted such that a spiral roll is established in the mixing tank away from the point of lime addition.

C. pH. Suitable methods of measuring pH values in excess of 12 shall be provided and maintained to measure the pH of the septage-lime mixture.

D. Dewatering. Dewatering is required prior to landfilling lime stabilized septage and may be desirable before land spreading. Criteria for dewatering facilities may be found in 12VAC5-580-700 of the Sewerage Regulations. In addition all filtrate from the dewatering facilities must be:

1. Disposed of in a subsurface soil absorption system; or

2. Collected in an impervious container or earthen basin for ultimate disposal in an approved sewerage system or treatment works or by land spreading.

E. Storage facilities. Regardless of the equipment used to land spread the lime stabilized septage, there will be extended time periods, particularly during winter, when the septage cannot be land applied. Therefore, storage facilities shall be provided. The design and construction of the storage facilities shall adhere to the following criteria:

1. General site requirements. If the storage facilities are to be constructed of manufactured materials, i.e., steel or concrete, the site requirements shall conform to 12VAC5-610-1080 B 2. Where an earthen storage facility is to be provided site requirements shall conform with 12VAC5-610-1080 B 1 and 2.

2. Design requirements.

a. Transfer facilities. When the storage facilities are located adjacent to the mixing facilities described in subsection B of this section the piping shall be arranged in such a manner to eliminate spillage, reduce splashing and facilitate distribution of the septage through the storage unit.

b. Receiving facilities. When the storage facilities are remote from the mixing facilities and require vehicular transport of the lime stabilized septage the receiving facilities shall conform to 12VAC5-610-1080 C 1.

c. Capacity. The storage volume shall be based upon a mass balance which considers as a minimum monthly pumping rates (number of loads pumped per month), number, location and nature of land spreading sites including soil type, crop cover and topography and seasonal application to cropped or pastured land. In no case shall the storage capacity be less than 60 days.

d. Storage facilities. When the storage facility is of a manufactured material (steel, concrete, etc.) it shall be watertight and fitted with appropriate piping and appurtenances to facilitate removal of the stored material. When the storage facility is of earthen construction it shall adhere to the design requirements contained in 12VAC5-610-1080 C 2 a (2), (3), (4), (5), and (6) above. See Appendix P.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.44, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-1100 Storage facilities for unstabilized septage

Unstabilized septage storage facilities shall conform to 12VAC5-610-1090 E above as applicable.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.45, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

Article 10 Sewage Dump Stations

12VAC5-610-1110 General

A dump station is a facility for receiving sewage from a recreational vehicle. The dump station shall be connected to an approved sewerage system or treatment works.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.46, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-1120 Location

The relationship of a dump station to structures and topographic features shall be in accordance with Table 4.4 and 12VAC5-610-470 A, C, F, and G. Dump stations shall be at least 50 feet from any habitation or camp site.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.47, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-1130 Design

A dump station shall consist of the following features:

A. A four inch sewer pipe trapped below the frost line and connected to an approved sewerage system.

B. The sewer inlet shall be surrounded by a concrete pad sloped to drain to the sewer inlet. The pad shall have minimum dimensions of 60 inches by 36 inches by six inches thick. The sewer inlet shall be at least six inches below the lip of the pad and located not more than 1/4 the length from one end of the pad. The end of the pad where the sewer inlet is located shall be curbed with a four inch curb.

C. The sewer inlet shall be fitted with a fly tight cover.

D. A water supply properly protected against cross connection and backflow shall be provided to facilitate washdown of the pad area. The water outlet shall be posted with a sign stating "Notice: Unsafe Water Outlet. This water for washdown purposes only".

E. The sewer line shall meet the material and construction specifications contained in Part IV, Article 2 of this chapter.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.48, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

Article 11 Nonpublic Drinking Water Supply Systems Utilized in Conjunction with Onsite Sewage Disposal Systems

12VAC5-610-1140 General

A. Authority for this article is found in § 32.1-164 B 6 of the Code of Virginia. This article pertains only to new construction where a nonpublic water supply, other than a private well, is to be constructed and utilized in conjunction with an onsite sewage disposal system. Approval of the water supply is an integral part of the issuance of an operation permit for a sewage disposal system (see 12VAC5-610-340) and no separate permit is required. An approval of a water supply under this section connotes a water supply meeting the quantity, quality and construction standards of a satisfactory water supply at the time of approval.

B. Quantity.

1. The system shall be capable of supplying water in adequate quantity for its intended usage. Failure to provide adequate capacity may cause intermittent flows and negative pressures which may cause contamination of the system through cross connections or other system deficiencies.

2. The source shall have a capacity to produce 150 gallons per bedroom per day for residential use.

3. The minimum system capacity (source plus storage) should be capable of delivering a sustained flow of five gallons per minute per connection for 10 minutes for ordinary residential use.

C. Quality.

1. Water sources described in this section shall be considered satisfactory if the water sample or samples test negative for coliform organisms. Sources with positive coliform counts, but with less than 100 MPN/100ml shall be provided with a means for continuous disinfection (chlorination).

2. A sample tap shall be provided at or near the water entry point into the system so that samples may be taken directly from the source; this requirement may be met by utilizing the first tap on the line near where the plumbing enters the house (may be a hose bib), provided the tap precedes any water treatment devices.

3. The entire water system including the well shall be disinfected prior to use. After operating the well to remove any remaining disinfectant, a sample of the water from the well shall be collected by the district or local health department for bacteriological examination. The sample may be collected by the owner, or an agent designated by the owner, provided the sample is submitted to a private, certified (by Division of Consolidated Laboratory Services) laboratory for analysis.

4. If tests indicate that the water is unsatisfactory and no other approval source is available, adequate approved methods of water treatment shall be applied. The district or local health department shall be consulted when treatment is necessary.

D. Approval. All water supplies covered by this chapter shall be approved by the district or local health department before being placed into service as a satisfactory water supply.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.49, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-1150 (Repealed.)

Historical Notes

Derived from VR355-34-02 § 4.50, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988; repealed, Virginia Register Volume 16, Issue 16, eff. July 1, 2000.

12VAC5-610-1160 Springs

A. Sanitary survey. Only springs which are found acceptable following a sanitary survey (12VAC5-610-1150 B) will be considered for use as a source of potable water. The following shall be considered when making the sanitary survey:

1. The spring's source should be an aquifer which is not subject to pollution;

2. The spring should not be subject to flooding;

3. Consideration should be given to fencing an adequate area completely around the spring to prevent contamination by people and/or animals;

4. Consideration should be given to diverting surface water away from the spring; and

5. The distance from other sources of pollution shall be the same as for subsurface soil absorption systems contained in Table 4.4 and 12VAC5-610-810 A.

B. Construction of springs and/or reservoirs.

1. The spring shall be completely enclosed. The walls and cover shall be constructed of durable watertight material.

2. All springs and/or reservoirs shall be accessible for cleaning and maintenance. When access is through the top, the opening shall have a minimum dimension of 24 inches. The opening shall be fitted with a solid, watertight cover which overlaps the framed opening and extends vertically down around the frame at least two inches (shoe box).

3. The top of the cover frame shall be at least two 12 inches above the surrounding ground surface.

4. Overflows shall be screened to prevent entrance of undesirable materials (See 12VAC5-610-1170 C 9).

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.51, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

12VAC5-610-1170 Cisterns

A. General. Cisterns shall be considered only when no other source of potable water is feasible.

B. Location and protection. The following precautions should be taken with regard to the location and protection of cisterns:

1. The distance from other sources of pollution shall be the same as for subsurface soil absorption systems contained in Table 4.4 and 12VAC5-610-810 A; and

2. Cisterns shall be located in a manner that will not subject them to flooding.

C. Construction.

1. The cistern shall be constructed of watertight, durable, structurally sound material, with a smooth interior surface.

2. When the cistern is filled by rainfall provisions shall be made to bypass, divert or otherwise remove the water that falls at the beginning of a rain.

3. Cisterns shall be accessible for cleaning.

4. Where a manhole cover is used, it shall be watertight and the manhole shall be at least 24 inches in diameter.

5. Where another type of cover is used, it shall be a solid, watertight cover which overlaps the framed opening and extends vertically down around the frame at least two inches.

6. The top of the cover frame shall be at least 12 inches above the surrounding ground surface.

7. All openings into the cistern shall be screened in order to prevent the entrance of insects, rodents and other animals and pollutants.

8. When screens and filters are utilized for filtering roof runoff, they shall be accessible for regular cleaning.

9. Drain and overflow pipes shall not be connected directly to any sewer, soil pipe, house drain or other waste pipe. An air-gap shall be provided on all drains and overflow pipes. Drains and overflow pipes shall be suitably screened.

10. Asphaltic roofing material or painted roofs should not be utilized in conjunction with cisterns because of the potential leaching of toxic materials.

D. Potability. Cisterns cannot be relied upon to provide potable water without adequate treatment. Adequate treatment consists of removal of solids washed from the roof and continuous disinfection.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-02 § 4.52, eff. February 5, 1986; amended, Virginia Register Volume 4, Issue 14, eff. May 11, 1988.

Chapter 613 Regulations for Alternative Onsite Sewage Systems

Part I General

12VAC5-613-10 Definitions

The following words and terms used in this chapter shall have the following meanings. Terms not defined in this chapter shall have the meanings prescribed in Chapter 6 (§ 32.1-163 et seq.) of Title 32.1 of the Code of Virginia or in 12VAC5-610 unless the plain reading of the language requires a different meaning.

"Alternative onsite sewage system," "AOSS," or "alternative onsite system" means a treatment works that is not a conventional onsite sewage system and does not result in a point source discharge.

"Best management practice" means a conservation or pollution control practice approved by the division, such as wastewater treatment units, shallow effluent dispersal fields, saturated or unsaturated soil zones, or vegetated buffers, that manages nutrient losses or other potential pollutant sources to minimize pollution of water resources.

"Biochemical oxygen demand, five-day" or "BOD₅" means the quantitative measure of the amount of oxygen consumed by bacteria while stabilizing, digesting, or treating biodegradable organic matter under aerobic conditions over a five-day incubation period; BOD₅is expressed in milligrams per liter (mg/l).

"Board" means the State Board of Health.

"Chesapeake Bay Watershed" means the following Virginia river basins: Potomac River Basin (see 9VAC25-260-390 and 9VAC25-260-400), James River Basin (see 9VAC25-260-410, 9VAC25-260-415, 9VAC25-260-420, and 9VAC25-260-430), Rappahannock River Basin (see 9VAC25-260-440), Chesapeake Bay and small coastal basins (see 9VAC25-260-520, Section 2 through Section 3g), and the York River Basin (see 9VAC25-260-530).

"Conventional onsite sewage system" means a treatment works consisting of one or more septic tanks with gravity, pumped, or siphoned conveyance to a gravity distributed subsurface drainfield.

"Department" means the Virginia Department of Health.

"Direct dispersal of effluent to ground water" means less than six inches of vertical separation between ground water and the point of effluent application or the bottom of an effluent-dispersal trench or other excavation. Other excavation excludes the following: minor tillage of the soil surface without soil removal; replacement of fill material with better quality fill material as determined by the department to improve the ability of the site to treat wastewater; house foundations; tank excavations; force main and header line excavations; and soil disturbances, including preexisting drainfields installed prior to July 17, 2017, that are not designed for surface or ground water drainage, and do not create a direct conduit to ground water.

"Disinfection" means a process used to destroy or inactivate pathogenic microorganisms in wastewater to render them non-infectious.

"Dissolved oxygen" or "DO" means the concentration of oxygen dissolved in effluent, expressed in mg/l or as percent saturation, where saturation is the maximum amount of oxygen that can theoretically be dissolved in water at a given altitude and temperature.

"Division" means the Division of Onsite Sewage and Water Services, Environmental Engineering, and Marina Programs within the department.

"Effluent" means sewage that has undergone treatment.

"General approval" means that a treatment unit has been evaluated in accordance with the requirements of this chapter and 12VAC5-610 and approved for TL-2 or TL-3 in accordance with this chapter.

"GPD/sf" means gallons per day per square foot.

"Ground water" means any water, except capillary moisture, beneath the land surface in the zone of saturation or beneath the bed of any stream, lake, reservoir, or other body of surface water wholly or partially within the boundaries of this Commonwealth, whatever the subsurface geologic structure in which such water stands, flows, percolates, or otherwise occurs. Ground water includes a seasonal or perched water table.

"High-level disinfection" means a disinfection method that results in a fecal coliform concentration less than or equal to 2.2 colonies/100 ml. Chlorine disinfection requires a minimum total residual chlorine (TRC) concentration at the end of a 30 minute contact time of 1.5 mg/l. Ultraviolet disinfection requires a minimum dose of 50,000 μW-sec/cm². Influent turbidity to the disinfection unit shall be less than or equal to 2 Nephelometric turbidity units (NTU) on average.

"Ksat" means saturated hydraulic conductivity.

"Large AOSS" means an AOSS that serves more than three attached or detached single-family residences with a combined average daily sewage flow greater than 1,000 GPD or a structure with an average daily sewage flow in excess of 1,000 GPD.

"Limiting feature" means a feature of the soil that limits or intercepts the vertical movement of water, including seasonal, perched or permanent water table, pans, soil restrictions, and pervious or impervious bedrock.

"Local health department" means the local health department having jurisdiction over the AOSS.

"Maintenance" means performing adjustments to equipment and controls and in-kind replacement of normal wear and tear parts such as light bulbs, fuses, filters, pumps, motors, or other like components. Maintenance includes pumping the tanks or cleaning the building sewer on a periodic basis. Maintenance shall not include replacement of tanks, drainfield piping, and distribution boxes or work requiring a construction permit and an installer.

"MGD" means million gallons per day.

"MPI" means minutes per inch.

"Operate" means the act of making a decision on one's own volition to (i) place into or take out of service a unit process or unit processes or (ii) make or cause adjustments in the operation of a unit process at a treatment works.

"Operation" means the biological, chemical, and mechanical processes of transforming sewage or wastewater to compounds or elements and water that no longer possess an adverse environmental or health impact.

"Operator" means any individual employed or contracted by any owner who is licensed or certified under Chapter 23 (§ 54.1-2300 et seq.) of Title 54.1 of the Code of Virginia as being qualified to operate, monitor and maintain an alternative onsite sewage system.

"Organic loading rate" means the biodegradable fraction of chemical oxygen demand (BOD, biodegradable fats, oils, and grease and volatile solids) delivered to a treatment component in a specified time interval expressed as mass per time or area; examples include pounds per day, pounds per cubic foot per day (pretreatment), or pounds per square foot per day (infiltrative surface or pretreatment). For a typical residential system, these regulations assume that biochemical loading (BOD₅) equals organic loading.

"Owner" means the Commonwealth or any of its political subdivisions, including sanitary districts, sanitation district commissions and authorities, or any individual, any group of individuals acting individually or as a group, or any public or private institution, corporation, company, partnership, firm, or association that owns or proposes to own a sewerage system or treatment works.

"pH" means the measure of the acid or base quality of water that is the negative log of the hydrogen ion concentration.

"Pollution" means such alteration of the physical, chemical, or biological properties of any state waters as will or is likely to create a nuisance or render such waters (i) harmful or detrimental or injurious to the public health, safety, or welfare or to the health of animals, fish, or aquatic life; (ii) unsuitable with reasonable treatment for use as present or possible future sources of public water supply; or (iii) unsuitable for recreational, commercial, industrial, agricultural, or other reasonable uses. Pollution shall include any discharge of untreated sewage into state waters.

"Point source discharge" means any discernible, confined, and discrete conveyance including any pipe, ditch, channel, tunnel, conduit, well, discrete fissure, container, rolling stock, concentrated animal feeding operation, landfill leachate collection system, vessel, or other floating craft from which pollutants are or may be discharged. This term does not include return flows from irrigated agriculture or agricultural storm water run-off.

"Project area" means one or more recorded lots or a portion of a recorded lot owned by the owner of an AOSS or controlled by easement upon which an AOSS is located or that is contiguous to a soil treatment area and that is designated as such for purposes of compliance with the performance requirements of this chapter. In the case of an AOSS serving multiple dwellings, the project area may include multiple recorded lots as in a subdivision.

"Project area boundary" or "project boundary" means the physical limits of the three-dimensional length, width, and depth of the project area, whereby each dimension is identified as follows: (i) the horizontal component is the length and width of the project area; (ii) the upper vertical limit is the ground surface in and around the AOSS; and (iii) the lower vertical limit is the limiting feature.

"Renewable operating permit" means an operation permit that expires and must be revalidated at a predetermined frequency or schedule in accordance with this chapter.

"Reportable incident" means one or more of the following: an alarm event lasting more than 24 hours; an alarm event that reoccurs; any failure to achieve one or more performance requirements; removal of solids; replacement of media; or replacement of any major component of the system including electric and electronic components, pumps, blowers, and valves. The routine cleaning of effluent filters is not a reportable incident.

"Saturated hydraulic conductivity" means a quantitative measure of a saturated soil's capacity to transmit water when subjected to a hydraulic gradient.

"Settleable solids" means a measure of the volume of suspended solids that will settle out of suspension within a specified time, expressed in milliliters per liter (ml/l).

"Sewage Handling and Disposal Regulations" means 12VAC5-610 or its successor.

"Small AOSS" means an AOSS that serves no more than three attached or detached single-family residences with a combined average flow of less than or equal to 1,000 GPD, or a structure with an average daily sewage flow of less than or equal to 1,000 GPD.

"Soil treatment area" means the physical location in the naturally occurring soil medium where final treatment and dispersal of effluent occurs.

"Standard disinfection" means a disinfection process that results in a fecal coliform concentration of less than or equal to 200 colonies/100 ml. Chlorine disinfection requires a minimum TRC concentration at the end of a 30 minute contact time of 1.0 mg/l. Influent TSS to the disinfection unit shall average 30 mg/l or less.

"Standard engineering practice" means the care, diligence, competence, and judgment that a reasonably prudent and experienced professional engineer licensed in the Commonwealth of Virginia would exercise given the circumstances, including site and soil conditions, of a particular AOSS design.

"State waters" means all water, on the surface and under the ground, wholly or partially within or bordering the Commonwealth or within its jurisdiction, including wetlands.

"Subsurface drainfield" means a system installed within the soil and designed to accommodate treated sewage from a treatment works.

"Surface waters" means: (i) all waters that are currently used, were used in the past, or may be susceptible to use in interstate or foreign commerce, including all waters that are subject to the ebb and flow of the tide; (ii) all interstate waters, including interstate wetlands; (iii) all other waters such as intrastate lakes, rivers, streams (including intermittent streams), mudflats, sandflats, wetlands, sloughs, prairie potholes, wet meadows, playa lakes, or natural ponds and the use, degradation, or destruction of which would affect or could affect interstate or foreign commerce including any such waters: (a) that are or could be used by interstate or foreign travelers for recreational or other purposes; (b) from which fish or shellfish are or could be taken and sold in interstate or foreign commerce; or (c) that are used or could be used for industrial purposes by industries in interstate commerce; (iv) all impoundments of waters otherwise defined as surface waters under this definition; (v) tributaries of waters identified in clauses (i) through (iv) of this definition; (vi) the territorial sea; and (vii) wetlands adjacent to waters (other than water that are themselves wetlands) identified in clauses (i) through (vi) of this definition.

"Total nitrogen" or "TN" means the measure of the complete nitrogen content of wastewater including all organic, inorganic, and oxidized forms expressed in mg/l as nitrogen.

"Total residual chlorine" or "TRC" means a measurement of the combined available chlorine and the free available chlorine available in a sample after a specified contact time.

"Total suspended solids" or "TSS" means a measure of the mass of all suspended solids in a sample typically measured in milligrams per liter (mg/l).

"Treatment level 2 effluent" or "TL-2 effluent" means secondary effluent as defined in 12VAC5-610-120 that has been treated to produce BOD₅ and TSS concentrations equal to or less than 30 mg/l each.

"Treatment level 3 effluent" or "TL-3 effluent" means effluent that has been treated to produce BOD₅ and TSS concentrations equal to or less than 10 mg/l each.

"Treatment unit" or "treatment system" means a method, technique, equipment, or process other than a septic tank or septic tanks used to treat sewage to produce effluent of a specified quality before the effluent is dispersed to a soil treatment area.

"Turbidity" means a measurement of the relative clarity of effluent as a result of the presence of varying amounts of suspended organic and inorganic materials or color.

"Vertical separation" means the vertical distance between the point of effluent application to the soil or the bottom of a trench or other excavation and a limiting feature of the soil treatment area such as seasonal high ground water, bedrock, or other restriction.

"Wetlands" means those areas that are inundated or saturated by surface or ground water at a frequency and duration sufficient to support, and that under normal circumstances do support, a prevalence of vegetation typically adapted for life in saturated soil conditions. Wetlands generally include swamps, marshes, bogs, and similar areas.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011; amended, Virginia Register Volume 33, Issue 20, eff. July 17, 2017.

12VAC5-613-20 Purpose and authority

A. Pursuant to the requirements of §§ 32.1-12 , 32.1-163.6, and 32.1-164 of the Code of Virginia, the board has promulgated this chapter to:

1. Establish a program for regulating the operation and maintenance of alternative onsite sewage systems;

2. Establish performance requirements for alternative onsite sewage systems;

3. Establish horizontal setbacks for alternative onsite sewage systems that are necessary to protect public health and the environment;

4. Discharge the board's responsibility to supervise and control the safe and sanitary collection, conveyance, transportation, treatment, and disposal of sewage by onsite sewage systems and treatment works as they affect the public health and welfare;

5. Protect the quality of surface water and ground water;

6. Guide the commissioner in determining whether a permit or other authorization for an alternative onsite sewage system shall be issued or denied; and

7. Inform owners, applicants, onsite soil evaluators, system designers, and other persons of the requirements for obtaining a permit or other authorization for an AOSS.

B. The division may, as it deems necessary, develop best management practices for the purposes of recognizing acceptable methods to reduce pollution from AOSSs.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC5-613-30 Applicability and scope

A. As provided in this section, this chapter governs the design, construction, and operation of AOSSs.

B. Part II of this chapter, Performance Requirements, applies only to AOSSs with applications filed on or after December 7, 2011.

C. Any AOSS with an application filed prior to December 7, 2011, is subject to the performance requirements contained in the regulations in effect at the time the system was permitted or the performance requirements contained in the operation permit.

D. Small AOSSs designed, constructed, permitted, and operated in accordance with this chapter; the prescriptive design, location, and construction criteria of 12VAC5-610-20; and the policies and procedures of the department are presumed to comply with the ground water quality requirements of 12VAC5-613-90 A.

E. Part III of this chapter, Operation and Maintenance Requirements, shall apply to all AOSSs, including those with applications filed prior to December 7, 2011.

F. Requirements for renewable operation permits contained in this chapter shall apply only to AOSSs with applications filed on or after December 7, 2011.

G. The laboratory sampling requirements of this chapter apply only to AOSSs with applications filed on or after December 7, 2011.

H. Any AOSS with an application filed prior to December 7, 2011, is subject to the laboratory sampling requirements contained in the regulations in effect at the time the system was permitted or the sampling requirements contained in the operation permit.

I. AOSSs designed pursuant to § 32.1-163.6 of the Code of Virginia are subject to the following requirements:

1. Performance requirements of this chapter unless waived pursuant to 12VAC5-613-210;

2. Horizontal setback requirements of this chapter;

3. Operation, maintenance, inspection, and sampling requirements of this chapter; and

4. Standard engineering practice.

J. Dispersal of treated or untreated sewage to a wetland that is subject to permitting by the Virginia Department of Environmental Quality pursuant to the requirements of Title 62.1 of the Code of Virginia is specifically excluded from this chapter.

K. Spray irrigation systems are subject to permitting by the Virginia Department of Environmental Quality and are specifically excluded from this chapter.

L. Treatment units for small AOSSs that are recognized by the department as generally approved for TL-2 or TL-3 as of December 7, 2011, shall retain such status for a period of five years from December 7, 2011, after which the units shall be evaluated pursuant to the requirements of this chapter.

M. After December 7, 2011, new applications for general approval for TL-2 or TL-3 shall be subject to the requirements of this chapter. The department may continue to evaluate any treatment unit for small AOSSs that is undergoing evaluation as of December 7, 2011, using the protocol in place on the date of application for general approval.

N. The additional nutrient requirements for AOSSs in the Chesapeake Bay watershed contained in 12VAC5-613-90 D shall take effect on December 7, 2013.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC5-613-40 Relationship to other regulations

A. This chapter is supplemental to 12VAC5-610 (Sewage Handling and Disposal Regulations).

B. All procedures pertaining to enforcement, minimum requirements for filing applications, and processing of applications, including appeals and case decisions contained in the Sewage Handling and Disposal Regulations shall apply to the permitting of AOSSs under this chapter.

C. In any case where there is a conflict between this chapter and the Sewage Handling and Disposal Regulations, this chapter shall control.

D. This chapter supersedes Table 5.4 of the Sewage Handling and Disposal Regulations for all AOSSs designed to disperse TL-2 or TL-3 effluent. Table 5.4 of the Sewage Handling and Disposal Regulations (12VAC5-610-950) shall govern the design of any AOSS designed to disperse septic tank effluent to the soil treatment area unless waived pursuant to 12VAC5-613-210.

E. All plans and specifications for AOSSs shall be properly sealed by a professional engineer licensed in the Commonwealth pursuant to Title 54.1 of the Code of Virginia unless such plans are prepared pursuant to an exemption from the licensing requirements of Title 54.1 of the Code of Virginia. All AOSS designs prepared by a professional engineer shall be reviewed by the department pursuant to § 32.1-163.6 of the Code of Virginia unless otherwise designated in writing by the professional engineer.

F. When AOSS designs are prepared pursuant to an exemption from the licensing requirements of Title 54.1 of the Code of Virginia, the designer shall provide a certification statement in a form approved by the division identifying the specific exemption under which the plans and specifications were prepared and certifying that the designer is authorized to prepare such plans pursuant to the exemption.

G. Each application under § 32.1-163.6 of the Code of Virginia shall include a site and soil characterization report using the Field Book for Describing and Sampling Soils, Version 2.0, National Soil Survey Center, Natural Resources Conservation Service, U.S. Department of Agriculture, September 2002. The report may contain such information that the designer deems appropriate; however, it must describe the following minimum attributes of the site of the proposed soil treatment area:

1. Depth to limiting features, seasonal or perched water tables, pans, restrictions, or pervious or impervious bedrock;

2. Slope of the project area;

3. Ksat or percolation rate at the proposed installation depth and at depths below the soil treatment area to demonstrate compliance with this chapter. Ksat or percolation rate may be estimated for small AOSSs. The Ksat or percolation rate must be measured using an appropriate device for large AOSSs;

4. Landscape or landform; and

5. Project area along with those physical features in the vicinity of the proposed AOSS normally associated with plans for onsite sewage systems; such physical features include streams, bodies of water, roads, utilities, wells and other drinking water sources, existing and proposed structures, and property boundaries.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC5-613-50 Violations and enforcement

A. Subject to the limitations of 12VAC5-613-30.B, failure by any owner of an AOSS to achieve one or more performance requirements prescribed by this chapter or specified for the AOSS shall be a violation of this chapter.

B. Failure by any owner to comply with the conditions of an operation permit shall be a violation of this chapter.

C. Failure by any owner to accomplish any mandated visit, operation, maintenance, repair, monitoring, sampling, reporting, or inspection requirement prescribed by this chapter shall be a violation of this chapter.

D. Failure by any owner to follow the approved operation and maintenance manual (O&M manual) shall be deemed a violation of this chapter when such failure results in the failure to achieve one or more performance requirements prescribed by this chapter.

E. Failure by any operator to perform any mandated activity in accordance with 12VAC5-613-110, 12VAC5-613-120, 12VAC5-613-180, or 12VAC5-613-190 shall be a violation of this chapter.

F. Nothing in this chapter shall be construed to limit the authority of the board, the commissioner, or the department to enforce this chapter or to enforce the requirements of 12VAC5-610.

G. In accordance with the Sewage Handling and Disposal Regulations and § 32.1-25 of the Code of Virginia, the commissioner may take such samples and conduct such monitoring, including ground water samples and monitoring, that he deems necessary to enforce this chapter.

H. The board, commissioner, and department may use any lawful means to enforce this chapter including voiding a construction or operation permit, imposition of civil penalties, or criminal prosecution pursuant to § 32.1-27 of the Code of Virginia.

I. Except when there is additional evidence that an AOSS has failed to achieve one or more of the performance requirements of this chapter or when a licensed operator has filed a report indicating that an AOSS cannot be returned to normal function via routine maintenance, the department shall not rely solely on the results of an individual grab sample to establish the factual basis for a violation of this chapter.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC5-613-60 Operation permits and land records

A. The department shall not issue an operation permit for an AOSS until the property owner has recorded an instrument that complies with § 15.2-2157 E of the Code of Virginia in the land records of the circuit court having jurisdiction over the site of the AOSS. The local health department shall receive legal documentation indicating that the instrument has been duly recorded before issuance of the operation permit.

B. When all or part of the project area is to be used in the management of nitrogen from a large AOSS, the property owner or the owner of the AOSS shall record legal documentation in the land records of the circuit court having jurisdiction over the site of the AOSS. Such documentation shall contain assurances that the land area will be protected and preserved in accordance with the management methods established by the designer. The local health department shall receive legal documentation indicating that the instrument has been duly recorded before issuance of the operation permit.

C. All large AOSSs and any AOSS permitted pursuant to 12VAC5-613-90 C shall be subject a renewable operating permit. Such permits shall be issued for a period of five years. The owner of the AOSS shall apply for a new permit at least 180 days prior to the expiration date.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC5-613-70 General approval testing and evaluation

The division shall develop a protocol to verify the expected performance of treatment units of small AOSSs that meet TL-2 or TL-3 effluent quality. The protocol to evaluate and test field performance of TL-3 treatment units shall include the following minimum requirements:

1. The manufacturer shall evaluate at least 20 treatment units installed in the Commonwealth of Virginia for single family residences occupied full-time, year-round throughout the testing and evaluation period;

2. The manufacturer shall provide the division with quarterly results of influent and effluent samples measuring, at a minimum, BOD and TSS for each installed treatment unit;

3. Operation and maintenance shall be performed on each treatment unit during the evaluation period in accordance with the provisions of this chapter; and

4. An independent third party with no stake in the outcome of the approval process shall oversee and administer the testing and evaluation protocol. Examples of an independent third party include faculty members in an appropriate program of an accredited college or university, a licensed professional engineer experienced in the field of environmental engineering, or a testing firm that is acceptable to the division.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

Part II Performance Requirements

12VAC5-613-80 Performance requirements; general

All AOSS designed, constructed, and operated pursuant to this chapter shall comply with the following performance requirements unless waived pursuant to 12VAC5-613-210:

1. The presence of raw or partially treated sewage on the ground's surface or in adjacent ditches or waterways is prohibited;

2. The exposure of insects, animals, or humans to raw or partially treated sewage is prohibited;

3. The backup of sewage into plumbing fixtures is prohibited;

4. The direct dispersal of effluent into ground water shall comply with 12VAC5-613-90 C;

5. All treatment units and treatment systems shall be designed for the anticipated receiving wastewater characteristics and peak flow;

6. Dosing of the treatment unit or treatment system shall accommodate the design peak flow within the treatment unit's rated capacity;

7. The AOSS shall be designed so that all components are of sufficient structural integrity to minimize the potential of physical harm to humans and animals;

8. The conveyance system for any AOSS shall be designed and installed with sufficient structural integrity to resist inflow and infiltration and to maintain forward flow;

9. The AOSS shall be designed to minimize noise, odor, or other nuisances at the property boundary;

10. Maximum trench bottom hydraulic loading rates for pressure-dosed systems using TL-2 and TL-3 effluent are found in Table 1 and are to be used as follows:

a. The designer is responsible for reducing loading rates according to the features and properties of the soils in the soil treatment area as well as for reducing loading rates for other types of dispersal;

b. Adherence to the maximum trench bottom hydraulic loading rate criteria herein does not assure or guarantee that other performance requirements of this chapter, including effluent dispersal or ground water quality, will be met. It is the designer's responsibility to ensure that the proposed design is adequate to achieve all performance requirements of this chapter;

c. Trench bottom hydraulic loading rates for pressure-dosed systems shall not exceed the values in Table 1;

d. Hydraulic loading rates shall be incrementally reduced from the TL-2 values in Table 1 when a treatment unit or system is not designed to achieve TL-2 or TL-3. In such cases, the designer shall, for monitoring purposes, specify the effluent quality of the treatment unit. If the specified BOD₅exceeds 60 mg/l, the designer shall use loading rates for septic tank effluent;

e. Trench bottom hydraulic loading rates for gravity dosed systems shall be reduced from the values in Table 1; and

f. Area hydraulic loading rates for systems such as drip dispersal, pads, and mounds shall be reduced from the values in Table 1 and shall reflect standard engineering practice.

| | Table 1 Maximum Pressure-Dosed Trench Bottom Hydraulic Loading Rates | | | | | --- | --- | --- | --- | --- | | | Percolation Rate (MPI) | Saturated hydraulic conductivity (cm/day) | TL-2 Effluent (gpd/sf) | TL-3 Effluent (gpd/sf) | | | ≤15 | > 17 | 1.8 | 3.0 | | | 15 to 25 | 15 to 17 | 1.4 | 2.0 | | | >25 to 45 | 10 to < 15 | 1.2 | 1.5 | | | >45 to 90 | 4 to < 10 | 0.8 | 1.0 | | | >90 | < 4 | 0.4 | 0.5 |

11. Septic tank effluent may only be discharged to a soil treatment area when the vertical separation to a limiting feature consists of at least 18 inches of naturally-occurring, in-situ soil. AOSSs designed to disperse septic tank effluent require at least 12 inches of soil cover over the soil treatment area;

12. Whenever the depth to a permeability limiting feature on the naturally occurring site is less than 18 inches as measured from the ground surface, whenever the treatment works does not provide at least 18 inches of vertical separation to a permeability limiting feature, or whenever the design is for a large AOSS, then the following shall apply:

a. The designer shall demonstrate that (i) the site is not flooded during the wet season, (ii) there is a hydraulic gradient sufficient to move the applied effluent off the site, and (iii) water mounding will not adversely affect the functioning of the soil treatment area or create ponding on the surface;

b. For large AOSSs, the department may require the owner to monitor the degree of saturation beneath the soil treatment area to verify that water mounding is not affecting the vertical separation; and

c. For any system in which artificial drainage is proposed as a method to meet the requirements of this chapter, the designer shall provide calculations or other documentation sufficient to demonstrate the effectiveness of the proposed drainage.

13. The following minimum effluent quality shall be met for the described vertical separation to limiting feature as measured from the point of effluent application or the bottom of the trench or other excavation:

| | Table 2 Minimum Effluent Requirements for Vertical Separation to Limiting Features | | | --- | --- | --- | | | Vertical Separation | Minimum Effluent Quality | | | ≥18" (requires naturally occurring, undisturbed soils) | Septic | | | <18" to 12" (requires minimum 6" of naturally occurring, undisturbed soils) | TL-2 | | | 0" to <12" | TL-3 and standard disinfection* | | | *Note: Where direct dispersal of effluent to ground water occurs, effluent quality shall be governed by 12VAC5-613-90 C. | |

14. The designer shall specify methods and materials that will achieve the performance requirements of this chapter whenever sand, soil, or soil-like material is used to increase the vertical separation.

15. All treatment units or treatment systems shall prevent the bulking of solids to the treatment area.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC5-613-90 Performance requirements; ground water protection

A. The AOSS shall not pose a greater risk of ground water pollution than systems otherwise permitted pursuant to 12VAC5-610. After wastewater has passed through a treatment unit or septic tank and through the soil in the soil treatment area, the concentration of fecal coliform organisms shall not exceed 2.2 cfu/100 ml at the lower vertical limit of the project area boundary.

B. Each large AOSS shall comply with TN limit of 5 mg/l at the project area boundary. Prior to the issuance of a construction permit, the designer shall demonstrate compliance with this requirement through modeling or other calculations. Such demonstration may incorporate multiple nitrogen removal methods such as pretreatment, vegetative uptake (only for AOSSs with shallow soil treatment areas), denitrification, and other viable nitrogen management methods. Ground water and other monitoring may be required at the department's discretion.

C. AOSSs with direct dispersal of effluent to ground water are subject to the following requirements:

1. If the concentration of any constituent in ground water is less than the limits set forth at 9VAC25-280, the natural quality for the constituent shall be maintained; natural quality shall also be maintained for all constituents not set forth in 9VAC25-280. If the concentration of any constituent in ground water exceeds the limit in the standard for that constituent, no addition of that constituent to the naturally occurring concentration shall be made. The commissioner shall consult with the Department of Environmental Quality prior to granting any variance from this subsection.

2. Ground water and laboratory sampling in accordance with 12VAC5-613-100 G.

3. The treatment unit or system shall comply with the following at a minimum:

a. The effluent quality from the treatment unit or system shall be measured prior to the point of effluent application to the soil treatment area and shall be as follows: BOD₅and TSS concentrations each equal to or less than 5 mg/l; fecal coliform concentrations less than or equal to 2.2 col/100 ml as a geometric mean with no sample exceeding 14 col/100 ml; and TN concentration of less than 5 mg/l;

b. High level disinfection is required; and

c. Treatment systems shall incorporate filtration capable of demonstrating compliance with an average turbidity of less than or equal to 2 NTU prior to disinfection.

4. Gravity dispersal to the soil treatment area is prohibited.

5. Loading rates to the soil treatment area shall not exceed the loading rates in Table 1 of 12VAC5-613-80.

6. A renewable operating permit shall be obtained and maintained in accordance with 12VAC5-613-60 C.

7. The designer shall provide sufficient hydrogeologic analysis to demonstrate that a proposed AOSS will function as designed for the life of the structure served without degradation of the soil treatment area. This shall include a determination of ground water flow direction and rate.

D. The following additional nutrient requirements apply to all AOSSs in the Chesapeake Bay Watershed:

1. All small AOSSs shall provide a 50% reduction of TN as compared to a conventional gravity drainfield system; compliance with this subdivision may be demonstrated through the following:

a. Compliance with one or more best management practices recognized by the division such as the use of a NSF 245 certified treatment; or

b. Relevant and necessary calculations provided to show one or both of the following:

(1) Effluent TN concentration of 20 mg/l measured prior to application to the soil dispersal field; or

(2) A mass loading of 4.5 lbs N or less per person per year at the project boundary provided that no reduction for N is allotted for uptake or denitrification for the dispersal of effluent below the root zone (>18 inches below the soil surface).

2. All large AOSSs up to and including 10,000 gallons per day shall provide a 50% reduction of TN at the project boundary as compared to a conventional gravity drainfield system. Compliance with this subdivision may be demonstrated as follows:

a. A demonstrated effluent quality of less than or equal to 20 mg/l TN measured prior to application to the soil treatment area; or

b. In situ monitoring of the treatment works within 24 vertical inches of the point of effluent application to the soil treatment area to demonstrate the effluent leaving the treatment works has a TN concentration of less than or equal to 20 mg/l. The designer shall identify an intermediate compliance point within the treatment system and a corresponding TN concentration for use in the event that a representative in situ sample cannot be obtained. The intermediate compliance point and the corresponding TN concentration for use must be approved by the department and shall be conditions of the operation permit.

The AOSS operation permit shall be conditioned upon compliance with the constituent concentrations approved pursuant to this subdivision.

3. All large AOSSs over 10,000 gallons per day shall comply with the following TN requirements:

a. A demonstrated effluent quality of less than or equal to 8 mg/l TN measured prior to application to the soil treatment area; or

b. In situ monitoring of the treatment works within 24 vertical inches of the point of effluent application to the soil treatment area to demonstrate the effluent leaving the treatment works has a TN concentration of less than or equal to 5 mg/l. The designer shall identify an intermediate compliance point within the treatment system and a corresponding TN concentration for use in the event that a representative in situ sample cannot be obtained. The intermediate compliance point and the corresponding TN concentration for use must be approved by the department and shall be conditions of the operation permit.

The AOSS operation permit shall be conditioned upon compliance with the constituent concentrations approved pursuant to this subdivision.

4. For direct dispersal of effluent to ground water in the Chesapeake Bay Watershed, TN concentration shall be less than or equal to 3 mg/l and total phosphorus concentration shall be less than or equal to 0.3 mg/l.

E. When an application is filed to repair or voluntarily upgrade an existing sewage system with an average daily sewage flow of 1,000 gallons per day or less, and the existing sewage system already disperses effluent to ground water as defined in 12VAC5-613-10 and the repair or upgrade must also be direct dispersal due to site conditions, then the repair or upgrade shall not be subject to the requirements of subsection C or subdivision D 4 of this section and 12VAC5-613-100 G. The repair or upgrade shall be subject to the following requirements:

1. A minimum 50% reduction of TN as compared to a conventional gravity drainfield system.

2. Provide TL-3 effluent and standard disinfection in accordance with Table 2 of subdivision 13 of 12VAC5-613-80 for systems with less than 12 inches vertical separation to ground water.

3. Monitoring pursuant to 12VAC5-613-100 D or E as appropriate.

F. Subsection E of this section does not apply to any application for repair or voluntary upgrade when the existing sewage system was installed on or after December 7, 2013, and the existing system was designed to meet the performance requirements for direct dispersal of effluent to ground water as set forth in subsection C or subdivision D 4 of this section and 12VAC5-613-100 G.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Errata, 28:8 VA.R. 762 December 19, 2011; amended, Virginia Register Volume 33, Issue 20, eff. July 17, 2017.

12VAC5-613-100 Performance requirements; laboratory sampling and monitoring

A. Laboratory sampling is not required for any small AOSS with an installed soil treatment area that is sized for septic tank effluent and complies with the requirements of 12VAC5-610 for septic tank effluent.

B. All effluent samples must be taken at the end of all treatment, prior to the point where the effluent is discharged to the soil treatment area unless changed pursuant to 12VAC5-613-90 or 12VAC5-613-210. The designer shall identify the sampling points. When required, the sampling point for chlorine disinfection shall be at the end of the chlorine contact tank if TRC is to be used to measure compliance.

C. All sampling and monitoring shall be conducted according to procedures approved under 40 CFR Part 136 or alternative methods approved by the U.S. Environmental Protection Agency unless other procedures have been specified in this chapter.

D. The owner of each small AOSS must ensure that an initial grab sample of the effluent from the treatment unit is collected within 180 days of system operation. The sample must be analyzed in accordance with 40 CFR Part 136 or alternative methods approved by the U.S. Environmental Protection Agency within the first 180 days of operation. Thereafter, if the treatment unit has received general approval, a grab sample is required once every five years. Samples shall be analyzed for BOD₅ and, if disinfection is required, fecal coliform. Treatment units utilizing chlorine disinfection may alternatively sample for TRC instead of fecal coliform. Sample results shall be submitted to the local health department by the 15th of the month following the month in which the sample was taken.

E. For small AOSSs that utilize a treatment unit that has not received general approval, in addition to the initial sample required by subsection D of this section, four additional grab samples of the effluent from the treatment unit shall be collected, analyzed, and submitted to the department within the first two years of operation and annually thereafter. The interval for collecting the samples shall not be less than quarterly or more than semiannually. Sample results shall be submitted to the local health department by the 15th of the month following the month in which the sample was taken. After two years of sampling in accordance with this subsection, the owner may submit a request to the department to reduce the sampling frequency to once every five years. The department shall grant such requests if the mean of five or more consecutive samples complies with the applicable performance requirements of this chapter.

F. Sampling and monitoring requirements for AOSS treatment systems with flows greater than 1,000 GPD are contained in Table 3:

| Table 3 Sampling and Monitoring for Large AOSSs | | | | | | | | --- | --- | --- | --- | --- | --- | --- | | PLANT SIZE | >2.0 MGD | >1.0 - to 2.0 MGD | > 100,000 GPD to 1.0 MGD | > 40,000 GPD to 100,000 GPD | >10,000 GPD to 40,000 GPD | >1,000 GPD to 10,000 GPD | | Flow | Totalizing, Indicating, & Recording | Totalizing, Indicating, & Recording | Totalizing, Indicating, & Recording | Totalizing, Indicating, & Recording | Measured | Measured or Estimate | | BOD₅, TSS | 24-HC* 1/day | 24-HC 5 days/wk | 8-HC 3 days/wk | 4-HC 1 day/wk | Grab quarterly | Grab 1/yr | | Total Nitrogen | 24-HC weekly | 24-HC weekly | 8-HC monthly | 4-HC quarterly | Grab quarterly | Grab 1/yr | | TRC, End of Contact Tank** | Grab daily | Grab daily | Grab weekly | Grab weekly | Grab weekly | Grab 1/yr | | Fecal Coliform*** | Grab weekly | Grab weekly | Grab monthly | Grab monthly | Grab quarterly | Grab 1/yr |

*HC – hourly, flow weighted composite samples

**if disinfection required and chlorine used

***if disinfection required and a disinfectant other than chlorine used

G. Systems with direct dispersal to ground water as described in 12VAC5-613-90 C shall comply with the following:

1. Small AOSS treatment systems:

a. Shall incorporate a method to remotely monitor the operation of treatment units and processes, including the status of the disinfection unit, and automatically notify the operator and local health department if an alarm condition occurs;

b. Shall be sampled quarterly in accordance with 12VAC5-613-90 C and as defined in the renewable operating permit; and

c. No treatment units or systems shall be deemed generally approved.

2. Large AOSSs must be continuously monitored for the proper operation of all treatment units. If the wastewater treatment works is not manned 24 hours a day, telemetry shall be provided that monitors all critical systems, including turbidity into the disinfection unit and the functionality of the disinfection unit, and notifies the operator and local health department if an alarm condition occurs.

a. Treatment works with a design flow of less than 40,000 GPD shall be sampled at least monthly in accordance with 12VAC5-613-90 C and as defined in the renewable operating permit.

b. Treatment works with a design flow of 40,000 GPD or greater shall be sampled at the frequency specified in Table 3 of this section. Total phosphorus and other limited parameters not listed in Table 3 of this section shall be conducted at a frequency defined in the renewable operating permit. The treatment works must comply with the continuous operability requirements of a Reliability Class I rating as described in 9VAC25-790. Appropriate backup power sources, equipment redundancy, and failsafe modes must be in place.

3. Ground water monitoring is required for all large AOSSs with direct dispersal of effluent to the ground water and such monitoring shall be conducted in accordance with the renewable operating permit.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Errata, 28:6 VA.R. 641 November 21, 2011.

12VAC5-613-110 Performance requirements; field measurements, sampling, and observations

A. For treatment units or treatment systems with flows greater than 1,000 GPD and less than or equal to 40,000 GPD, the following parameters shall be evaluated or tested when applicable: flow, pH, TRC, DO, odor, turbidity (visual), and settleable solids.

B. For treatment systems with flows greater than 40,000 GPD, the operator shall follow the operational and control testing requirements of the O&M manual.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

Part III Operation and Maintenance Requirements

12VAC5-613-120 Operator responsibilities

A. Whenever an operator performs a visit that is required by this chapter or observes a reportable incident, he shall document the results of that visit in accordance with 12VAC5-613-190 or as otherwise specified in the operation permit.

B. Whenever an operator performs a visit that is required by this chapter, he shall do so in such a manner as to accomplish the various responsibilities and assessments required by this chapter through visual or other observations and through laboratory and field tests that are required by this chapter or that he deems appropriate.

C. Each operator shall keep an electronic or hard copy log for each AOSS for which he is responsible. The operator shall provide a copy of the log to the owner. In addition, the operator shall make the log available to the department upon request. At a minimum, the operator shall record the following items in the log:

1. Results of all testing and sampling;

2. Reportable incidents;

3. Maintenance, corrective actions, and repair activities that are performed other than for reportable incidents;

4. Recommendations for repair and replacement of system components;

5. Sludge or solids removal; and

6. The date reports were given to the owner.

D. When performing activities pursuant to a visit that is required by this chapter, the operator is responsible for the entire AOSS, including treatment components and soil treatment area components and the operator shall follow the approved O&M manual.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC5-613-130 Sludge and solids removal

Any person who pumps or otherwise removes sludge or solids from any septic tank or treatment unit of an AOSS shall file a report with the appropriate local health department on a form approved by the division.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC5-613-140 Owner responsibilities

It is the owner's responsibility to do the following:

1. Have the AOSS operated and maintained by an operator;

2. Have an operator visit the AOSS at the frequency required by this chapter;

3. Have an operator collect any samples required by this chapter;

4. Keep a copy of the log provided by the operator on the property where the AOSS is located in electronic or hard copy form, make the log available to the department upon request, and make a reasonable effort to transfer the log to any future owner;

5. Follow the O&M manual and keep a copy of the O&M manual in electronic or hard copy form for the AOSS on the property where the AOSS is located, make the O&M manual available to the department upon request, and make a reasonable effort to transfer the O&M manual to any future owner; and

6. Comply with the onsite sewage system requirements contained in local ordinances adopted pursuant to the Chesapeake Bay Preservation Act (§ 10.1-2100 et seq. of the Code of Virginia) and the Chesapeake Bay Preservation Area Designation and Management Regulations (9VAC10-20) when an AOSS is located within a Chesapeake Bay Preservation Area.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC5-613-150 Operator requirements for AOSS with flows up to 40,000 GPD, minimum frequency of visits

The owner of each AOSS shall have that AOSS visited by an operator in accordance with Table 4.

| Table 4 Minimum Operator Visit Frequency for AOSSs up to 40,000 GPD | | | | --- | --- | --- | | Avg. Daily Flow | Initial Visit | Regular visits following initial visit | | ≤1,000 GPD | Within 180 calendar days of the issuance of the operation permit | Every 12 months | | >1,000 GPD to 10,000 GPD | First week of actual operation | Quarterly | | >10,000 GPD to 40,000 GPD | First week of actual operation | Monthly |

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC5-613-160 Operator requirements for flows greater than 40,000 GPD

A. AOSSs with average daily flows greater than 40,000 GPD shall be attended by a licensed operator and manned in accordance with the recommendations specified in the Sewage Collection and Treatment Regulations for sewage treatment works (9VAC25-790).

B. When the operating staff cannot be physically present at the treatment works site during the designated manning hours, then the operating staff shall have a method in place for an operator to respond to the operation and maintenance needs of the treatment works within the timeframe provided by the O&M manual or as otherwise directed by the department.

C. Attendance by the operator pursuant to this section shall not be waived.

D. The department may reduce operator or staffing requirements when automatic monitoring, telemetry, or other electronic monitoring or process controls are employed. All reductions must be approved by the division director.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC5-613-170 Operation and maintenance manual

A. This chapter outlines the minimum requirements for operation, maintenance, sampling, and inspection of AOSSs. Operation, maintenance, sampling, and inspection schedules for some AOSSs may exceed these minimum requirements, in which case the designer is responsible for determining such additional requirements based upon the proposed use, design flow, project area, loading rates, nitrogen removal, treatment level, and other factors.

B. Prior to the issuance of an operation permit, the owner shall ensure that an O&M manual is submitted to the local health department for approval.

C. The O&M manual shall be easily understood by any potential owner and shall include the following minimum items:

1. Basic information on the AOSS design including treatment unit capacity, installation depth, pump operating conditions, a list of the components comprising the AOSS, a dimensioned site layout, sampling locations, and contact information for replacement parts for each unit process;

2. A list of any control functions and how to use them;

3. All operation, maintenance, sampling, and inspection schedules for the AOSS, including any requirements that exceed the minimum requirements of this chapter;

4. The performance (laboratory) data sampling and reporting schedule;

5. The limits of the AOSS design and how to operate the system within those design limits;

6. For systems with flows greater than 40,000 GPD, the O&M manual shall include operational and control testing recommendations that shall be based upon 9VAC25-790-970; and

7. Other information deemed necessary or appropriate by the designer.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC5-613-180 Mandatory visits; inspection requirements

When an operator is required to make a visit to an AOSS the operator shall, at a minimum, accomplish the following:

1. Inspect all components of the AOSS and conduct field measurements, sampling, and other observations required by this chapter, the O&M manual, or deemed necessary by the operator to assess the performance of the AOSS and its components.

2. Review and evaluate the operation of the AOSS, perform routine maintenance, make adjustments, and replace worn or dysfunctional components with functionally equivalent parts such that the system can reasonably be expected to return to normal operation.

3. If the AOSS is not functioning as designed or in accordance with the performance requirements of this chapter and, in the operator's professional judgment, cannot be reasonably expected to return to normal operation through routine operation and maintenance report immediately to the owner the remediation efforts necessary to return the AOSS to normal operation.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC5-613-190 Reports

When required to file a report, the operator shall complete the report in a form approved by the division. In accordance with § 32.1-164 H of the Code of Virginia, the operator shall file each report using a web-based system and pay the required fee. The operator may, solely at his own discretion, file reports in addition to those required by this chapter. Each report shall be filed by the 15th of the month following the month in which the visit occurred and shall include the following minimum elements:

1. The name and license number of the operator;

2. The date and time of the report;

3. The purpose of the visit, such as required visit, follow-up, or reportable incident;

4. A summary statement stating whether:

a. The AOSS is functioning as designed and in accordance with the performance requirements of this chapter;

b. After providing routine operation and maintenance, the operator believes the AOSS will return to normal operation; or

c. The system is not functioning as designed or in accordance with the performance requirements of this chapter and additional actions are required by the owner to return the AOSS to normal operation;

5. All maintenance performed or adjustments made, including parts replaced;

6. The results of field measurements, sampling, and observations;

7. The name of the laboratory that analyzed samples, if appropriate; and

8. A statement certifying the date the operator provided a copy of the report in electronic or hard copy form to the owner.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

Part IV Horizontal Setback Requirements

12VAC5-613-200 Horizontal setback requirements

AOSSs designed pursuant to § 32.1-163.6 of the Code of Virginia are subject to the following horizontal setbacks that are necessary to protect public health and the environment:

1. The horizontal setback distances as found in 12VAC5-610 that apply to public and private drinking water sources of all types, including wells, springs, reservoirs, and other surface water sources, except that in cases where an existing sewage system is closer to a private drinking water source, the AOSS shall be no closer to the drinking water source than the existing sewage system;

2. The horizontal setback distances that apply to shellfish waters as found in 12VAC5-610;

3. The horizontal setback distances that apply to sink holes as found in 12VAC5-610;

4. A five foot horizontal separation to a wetland that is subject to permitting by the Virginia Department of Environmental Quality pursuant to the requirements of Title 62.1 of the Code of Virginia; and

5. Unless the AOSS complies with the ground water protection requirements of 12VAC5-613-90.C, a horizontal separation between the soil treatment area and any drainage trench or excavation that comes within six inches vertically of ground water shall be as follows:

a. AOSSs utilizing septic tank effluent shall be subject to a horizontal separation contained in 12VAC5-610;

b. AOSSs utilizing TL-2 or TL-3 (without disinfection) shall be subject to a horizontal separation of 20 feet; and

c. AOSSs utilizing TL-3 with disinfection shall be subject to a horizontal separation of 10 feet.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

Part V Waivers from Certain Performance Requirements

12VAC5-613-210 Waivers from certain performance requirements

A. A professional engineer designing a treatment works pursuant to § 32.1-163.6 of the Code of Virginia may deviate from the design criteria in subdivisions 10, 11, and 13 of 12VAC5-613-80 and from the laboratory sampling location specified in 12VAC5-613-100 B through F in accordance with this part.

B. Designs pursuant to this part shall at a minimum be substantiated by:

1. Documentation from applicable engineering standards, texts, or other publications;

2. Relevant peer-reviewed research; or

3. Regulations or technical guidance from other states or the U.S. Environmental Protection Agency.

C. The soil treatment area shall be adequately sized to accommodate the hydraulic and organic capacity of the underlying soil to be used;

D. Sampling and monitoring pursuant to 12VAC5-613-100 B through F may be accomplished either in situ, immediately beneath the soil treatment area and within 24 inches of the point of effluent application, or within the treatment system at a point identified by the design engineer.

1. The professional engineer shall provide a sampling and monitoring plan to demonstrate that the design complies with the water quality standards in 12VAC5-613-90.

2. For in situ monitoring, the design engineer shall specify locations within the soil treatment area's zone of influence (i.e., mounding) where samples representative of the effluent quality being achieved by the treatment works can be collected. Monitoring wells or lysimeters shall be located at least six inches above any seasonal or permanent water table. Monitoring may be conducted using sampling wells, lysimeters, or other methods approved by the department. Suction lysimeters may not be used for fecal coliform monitoring.

3. The design engineer shall identify an intermediate compliance point (or points) within the treatment system along with corresponding constituent concentrations (e.g., BOD₅, fecal coliforms) for use if in situ monitoring is not desired or if an in situ sample cannot be obtained for any reason. The intermediate compliance point and the corresponding constituent concentrations shall be approved by the department. The AOSS operation permit shall be conditioned upon compliance with the constituent concentrations approved pursuant to this subdivision.

E. The following additional performance requirements shall apply to in situ monitoring:

1. BOD₅ less than or equal to 5 mg/l.

2. Fecal coliforms less than or equal to 2.2 col/100 ml.

F. The frequency of sampling shall be in accordance with 12VAC5-613-100.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

Chapter 620 Regulations Governing Fees for Onsite Sewage Disposal Systems, Alternative Discharge Systems, and Private Wells

Part I Definitions

12VAC5-620-10 Definitions

The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise:

"Agent" means a legally authorized representative of the owner.

"Alternative discharging system" means any device or system that results in a point source discharge of treated sewage for which the board may issue a permit authorizing construction and operation when the system is regulated by the State Water Control Board pursuant to a general Virginia Pollutant Discharge Elimination System permit for an individual single family dwelling with flows less than or equal to 1,000 gallons per day.

"Board" means the State Board of Health.

"Certification letter" means a letter issued by the commissioner in lieu of a construction permit, which identifies a specific site and recognizes the appropriateness of the site for an onsite wastewater disposal system.

"Commissioner" means the State Health Commissioner.

"Construction of private wells" means acts necessary to construct private wells, including the location of private wells, the boring, digging, drilling, or otherwise excavating a well hole and installing casing with or without well screens, or well curbing.

"Decommission" means to permanently seal an existing private well in accordance with the requirements of the Private Well Regulations (12VAC5-630).

"Department" means the Virginia Department of Health.

"Dewatering well" means a driven well constructed for the sole purpose of lowering the water table and kept in operation for a period of 60 days or less. Dewatering wells are used to allow construction in areas where a high water table hinders or prohibits construction and are always temporary in nature.

"Family" means the economic unit which shall include the owner, the spouse of the owner, and any other person actually and properly dependent upon or contributing to the family's income for subsistence. A husband and wife who have been separated and are not living together, and who are not dependent on each other for support, shall be considered separate family units. The family unit, which is based on cohabitation, is considered to be a separate family unit for determining if an application fee may be waived. The cohabiting partners and any children shall be considered a family unit.

"Fee schedule" means a listing by item of the fees to be charged by the department for processing applications and for other services rendered by the department.

"Income" means total cash receipts of the family before taxes from all sources. These include money wages and salaries before any deductions, but do not include food or rent in lieu of wages. These receipts include net receipts from nonfarm or farm self-employment (e.g., receipts from the family's own business or farm after deductions for business or farm expenses.) They include regular payments from public assistance (including Supplemental Security Income), social security or railroad retirement, unemployment and worker's compensation, strike benefits from union funds, veterans' benefits, training stipends, alimony, child support, and military family allotments or other regular support from an absent family member or someone not living in the household; private pensions, government employee pensions, and regular insurance or annuity payment; and income from dividends, interest, rents, royalties, or periodic receipts from estates or trusts. These receipts further include funds obtained through college work study programs, scholarships, and grants to the extent said funds are used for current living costs. Income does not include the value of food stamps, WIC checks, fuel assistance, money borrowed, tax refunds, gifts, lump sum settlements, inheritances or insurance payments, withdrawal of bank deposits, earnings of minor children, money received from the sale of property. Income also does not include funds derived from college work study programs, scholarships, loans, or grants to the extent such funds are not used for current living costs.

"Minor modification of an existing sewage disposal system" means an alteration that is not a repair, voluntary upgrade, or routine maintenance, does not result in an increase in treatment level or volume of the system, and does not require evaluation of the soil conditions prior to issuance of a permit. Minor modifications include but are not limited to relocation of a system component or an additional plumbing connection to the system that does not increase the actual or estimated flow of the system.

"Onsite sewage disposal system" means a sewerage system or treatment works designed not to result in a point source discharge.

"Owner" means any person who owns, leases, or proposes to own or lease a private well, an onsite sewage disposal system, or an alternative discharging system.

"Person" means the Commonwealth or any of its political subdivisions, including sanitary districts, sanitation district commissions and authorities, any individual, any group of individuals acting individually or as a group, or any public or private institution, corporation, company, partnership, firm or association which owns or proposes to own a sewerage system, treatment works or private well.

"Principal place of residence" means the dwelling unit, single family dwelling, or mobile home where the owner lives.

"Private well" means any water well constructed for a person on land which is owned or leased by that person and is usually intended for household, groundwater source heat pump, agricultural use, industrial use, use as an observation or monitoring well, or other nonpublic water well. A dewatering well, for the purposes of this chapter, is not a private well.

"Repair" means the construction or replacement of all or parts of a sewage disposal system or private well to correct a failing, damaged, or improperly functioning system or well when such construction or replacement is required by the board's regulations.

"Replacement of a private well" means the construction of a private well to be used in lieu of an existing private well.

"Review Board" means the State Sewage Handling and Disposal Appeals Review Board.

"Sewage" means water-carried and non-water-carried human excrement, kitchen, laundry, shower, bath or lavatory wastes separately or together with such underground, surface, storm and other water and liquid industrial wastes as may be present from residences, buildings, vehicles, industrial establishments or other places.

"Sewerage system" means pipelines or conduits, pumping stations and force mains and all other construction, devices and appliances appurtenant thereto, used for the collection and conveyance of sewage to a treatment works or point of ultimate disposal.

"Treatment works" means any device or system used in the storage, treatment, disposal or reclamation of sewage or combinations of sewage and industrial wastes, including but not limited to pumping, power and other equipment and appurtenances, septic tanks and any works, including land, that are or will be (i) an integral part of the treatment process or (ii) used for ultimate disposal of residues or effluents resulting from such treatment.

"Voluntary upgrade" means an improvement to an existing onsite sewage disposal system or alternative discharging system that (i) is not required for compliance with any law or regulation and (ii) results in no net increase in the permitted volume or strength of sewage dispersed by the system.

"Well" means any artificial opening or artificially altered natural opening, however made, by which groundwater is sought or through which groundwater flows under natural pressure or is intended to be artificially drawn; provided this definition shall not include wells drilled for the purpose of exploration or production of oil or gas, for building foundation investigation and construction, elevator shafts, grounding of electrical apparatus, or the modification or development of springs.

History

• Statutory Authority: §§ 32.1-12, 32.1-164, and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-03 § 1, eff. July 1, 1989; amended, Virginia Register Volume 32, Issue 10, eff. February 12, 2016.

Part II General Information

12VAC5-620-20 (Repealed.)

History

• Historical Notes: Derived from VR355-34-03 § 2.1, eff. July 1, 1989; repealed, Virginia Register Volume 32, Issue 10, eff. February 12, 2016.

12VAC5-620-30 Purpose of regulations

The board has promulgated these regulations to:

1. Establish a procedure for determining the fees for services provided by the department for onsite sewage systems, alternative discharge systems, and private wells;

2. Establish procedures for the refund of fees; and

3. Establish procedures for the waiver of fees.

History

• Statutory Authority: §§ 32.1-12, 32.1-164, and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-03 § 2.2, eff. July 1, 1989; amended, Virginia Register Volume 32, Issue 10, eff. February 12, 2016.

12VAC5-620-40 Compliance with the Administrative Process Act

The provisions of the Virginia Administrative Process Act (§ 2.2-4000 et. seq. of the Code of Virginia) shall govern the promulgation and administration of these regulations and shall govern the decisions of cases under this chapter.

History

• Statutory Authority: §§ 32.1-12, 32.1-164, and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-03 § 2.3, eff. July 1, 1989; amended, Virginia Register Volume 32, Issue 10, eff. February 12, 2016.

12VAC5-620-50 Powers and procedures of regulations not exclusive

The commissioner may enforce these regulations through any means lawfully available.

History

• Statutory Authority: §§ 32.1-12, 32.1-164, and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-03 § 2.4, eff. July 1, 1989; amended, Virginia Register Volume 32, Issue 10, eff. February 12, 2016.

12VAC5-620-60 [Reserved]. (Reserved)

Part III Fees

12VAC5-620-70 Establishing fees

A. The commissioner shall establish a schedule of fees to be charged by the department for services related to construction, maintenance, and repair or replacement of onsite sewage disposal systems, alternative discharge systems, and private wells and for appeals before the Review Board.

B. In establishing fees, the commissioner shall consider the actual or estimated average cost to the agency of delivering each service included in the schedule of fees.

The following fee schedule is hereby established:

| SCHEDULE OF FEES | | | --- | --- | | Application or Service | Fee | | Certification letter, no onsite soil evaluator/professional engineer (OSE/PE) documentation (no charge for well) | $350 | | Certification letter with OSE/PE documentation, ≤1,000 gpd | $320 | | Certification letter with OSE/PE documentation, >1,000 gpd | $1,400 | | Construction permit for treatment works only, no OSE/PE documentation | $425 | | Combined well and treatment works construction permit, no OSE/PE documentation | $725 | | Combined well and treatment works construction permit with OSE/PE documentation, ≤1,000 gpd | $525 | | Construction permit for treatment works only with OSE/PE documentation, ≤1,000 gpd | $225 | | Construction permit for treatment works only with OSE/PE documentation, >1,000 gpd | $1,400 | | Combined well and treatment works construction permit with OSE/PE documentation, >1,000 gpd | $1,700 | | Private well construction or abandonment permit, with or without OSE/PE documentation | $300 | | Closed-loop geothermal well system (one fee per well system) | $300 | | Alternative discharge system inspection fee | $75 | | Minor modification to an existing system | $100 | | Appeal before the Review Board | $135 |

History

• Statutory Authority: §§ 32.1-12, 32.1-164, and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-03 § 3.1, eff. July 1, 1989; amended, Virginia Register Volume 32, Issue 10, eff. February 12, 2016.

12VAC5-620-75 Fee remittance; application completeness

A. Each applicant shall remit any required application fee to the department at the time of making application. In any case where an application fee is required, including requests for hearings before the Review Board, the application will be deemed to be incomplete and will not be accepted or processed until the fee is paid.

B. The owner of an alternative discharge system shall pay the monitoring fee to the department for monitoring inspections conducted by the department that are mandated by 12VAC5-640. The department shall waive the monitoring fee when it conducts a monitoring inspection that is not mandated by 12VAC5-640.

History

• Statutory Authority: §§ 32.1-12, 32.1-164, and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 12, 2016.

12VAC5-620-80 Waiver of fees

A. An owner whose family income is at or below the 2013 Poverty Income Guidelines for the 48 Contiguous States and the District of Columbia established by the Department of Health and Human Services, 78 FR 5182 (January 24, 2013), or any successor guidelines, shall not be charged a fee pursuant to this chapter.

B. Any person applying for a permit to construct a pit privy shall not be charged a fee for filing the application.

C. Any person applying for a permit to repair an onsite sewage disposal system or alternative discharging system shall not be charged a fee for filing the application.

D. Any person applying for a construction permit for the replacement of a private well may be charged a fee for filing the application. Any application fee paid for a construction permit for a replacement well shall be refunded in full upon receipt by the department of a Uniform Water Well Completion Report, pursuant to 12VAC5-630-310, indicating that the well that was replaced has been permanently and properly abandoned or decommissioned.

E. Any person applying for a permit to properly and permanently abandon or decommission an existing well on property that is his principal place of residence shall not be charged a fee for filing the application.

F. Any person who applies to renew a construction permit for an onsite sewage disposal system, alternative discharge system, or private well shall not be charged a fee for filing the application, provided that:

1. The site and soil conditions upon which the permit was issued have not changed;

2. The legal ownership of the property has not changed;

3. A building permit for the facility to be served by the sewage system or well has been obtained or construction of the facility has commenced;

4. No previous renewal of the permit has been granted;

5. The expiration date of the renewed permit shall be the date 18 months following the expiration date of the original permit; and

6. Where the construction permit is for an alternative discharging system, the permit must comply with 9VAC25-110, Virginia Pollutant Discharge Elimination System (VPDES) General Permit for Domestic Sewage Discharges of Less Than or Equal to 1,000 Gallons per Day, issued by the State Water Control Board.

G. Any person whose application for a certification letter or for a permit to construct an onsite sewage disposal system, alternative discharging system, or private well is denied may file one subsequent application for the same site-specific construction permit for which the application fee shall be waived, provided that:

1. The subsequent application is filed within 90 days of receiving the notice of denial for the first application;

2. The denial is not currently under appeal; and

3. The application fee for the first application has not been refunded.

History

• Statutory Authority: §§ 32.1-12, 32.1-164, and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-03 § 3.2, eff. July 1, 1989; amended, Virginia Register Volume 32, Issue 10, eff. February 12, 2016.

12VAC5-620-90 Refunds of application fee

A. An applicant for a construction permit or certification letter whose application is denied may apply for a refund of the application fee. The application fee shall be refunded to the owner or agent, if applicable, if the department denies an application for the land upon which the owner intends to build his principal place of residence. When the application was made for both a sewage disposal system and a private well, both fees may be refunded at the owner's request. Any such request shall be considered a withdrawal of the application.

B. An applicant for a construction permit or a certification letter may request a refund of the application fee if the applicant voluntarily withdraws his application before the department issues the requested permit. The application fee will be refunded if the application is withdrawn before the department makes a site visit for the purpose of evaluating the application.

C. An applicant who has paid an application fee for a replacement well shall be refunded the application fee in full upon receipt by the department of a Uniform Water Well Completion Report, pursuant to 12VAC5-630-310, showing that the well that was replaced has been properly and permanently abandoned or decommissioned.

D. All applications for refunds must be made to the department no later than 12 months following the date upon which the applicant receives notification that his application for a construction permit or certification letter has been denied, within 12 months following the date upon which his application was withdrawn, or within 12 months following the date upon which any appeals of the denial of the application have been concluded.

E. All applications for refunds shall be made in writing in a form approved by the department.

F. Applications that have been withdrawn are not subject to appeal.

History

• Statutory Authority: §§ 32.1-12, 32.1-164, and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-03 § 3.3, eff. July 1, 1989; amended, Virginia Register Volume 32, Issue 10, eff. February 12, 2016.

12VAC5-620-100 Determining eligibility for waiver based on family income

A. An owner seeking a waiver of an application fee shall request the waiver on the application form. The department will require information as to income, family size, financial status and other related data. The department shall not process the application until final resolution of the eligibility determination for waiver.

B. It is the owner's responsibility to furnish the department with the correct financial data in order to be appropriately classified according to income level and to determine eligibility for a waiver of an application fee. The owner shall be required to provide written verification of any employment or nonemployment income such as check stubs, written letter from an employer, W-2 forms, or other documentation acceptable to the department in order to provide documentation for the application.

C. The proof of income must reflect current income that is expected to be available during the next 12-month period. Proof of income must include, where applicable, name of employer, amount of gross earnings, and pay period for stated earnings. If no pay stub is submitted, a written statement must include the name, address, telephone number, and title of person certifying the income.

History

• Statutory Authority: §§ 32.1-12, 32.1-164, and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-03 § 3.3, eff. July 1, 1989; amended, Virginia Register Volume 32, Issue 10, eff. February 12, 2016.

Chapter 630 Private Well Regulations

Article 1 General Requirements

12VAC5-630-10 Definitions

The following words and terms, when used in this chapter, shall have the following meanings unless the context clearly indicates otherwise.

"Abandoned well" means a private well from which the pump has been disconnected for reasons other than repair or replacement, or the use of which has been discontinued or which has been pronounced abandoned by the owner. A temporarily abandoned well is a well that is intended to be returned to service as a source of water at some future time. A permanently abandoned well is a well that is not intended to be used.

"Agent" means a legally authorized representative of the owner.

"Agricultural operation" means an operation devoted to the bona fide production of crops, animals, or fowl, including the production of fruits and vegetables of all kinds; meat, dairy, and poultry products; nuts, tobacco, nursery and floral products; and the production and harvest of products from silviculture activity.

"Annular space" means the space between the well bore wall and the outside of a water well casing pipe or between a casing pipe and a liner pipe.

"Aquifer" means a geologic formation, group of formations, or part of a formation that has the capability to store and transmit water in sufficient quantity to constitute a usable supply source.

"Bedrock" means the solid, potentially fractured and fissured rock formations that occur beneath soils, underlying sediment deposits, or weathered material.

"Beneficial use" means use of water that includes domestic, agricultural, commercial, industrial, and investigative purposes.

"Bioretention pond" means a best management practice structure engineered for the purpose of reducing the pollutant load in storm water runoff to surface water and groundwater systems.

"Biosolids" means solid, semisolid, or liquid materials removed from municipal sewage and treated to be suitable for recycling as fertilizer , as defined in 9VAC25-31-10 and 9VAC25-32-10. For the purpose of this chapter, biosolids do not include exceptional quality biosolids as that term is defined in 9VAC25-32-10.

"Board" means the State Board of Health.

"Bored well" means a well that is excavated by means of a soil auger (hand or power) as distinguished from a well that is drilled, driven, dug, or jetted.

"Casing" means a hollow cylindrical device (typically steel, plastic, or concrete) that is installed in a well to maintain the well opening and to provide a seal.

"Clean fill" means any combination of undisturbed soil and natural earth material, commercially available quarried sand or gravel product, and cuttings from the well being constructed, provided that the materials do not contain contaminated media. In this context, undisturbed soil and natural earth materials refers to unconsolidated mineral and organic material on the immediate surface of the Earth that developed naturally on the property on which it originates.

"Closed-loop ground-source heat pump well" means a well consisting of a sealed loop of plastic pipe buried vertically beneath the earth's surface to allow heat transfer between the fluid in the pipe and the earth. Horizontal closed-loop ground source heat pump pipe configurations installed in trenches, including those which may intercept shallow groundwater, are excluded.

"Coliform" means a broad group of naturally occurring bacteria species found in soils and rocks. Coliform bacteria are more prevalent in near-surface soils, and their presence in well water may indicate the possible presence of more harmful pathogens.

"Collapsing material" means soil or gravel material that collapses upon itself forming a seal with the casing and leaves no voids around the casing.

"Commercially dependent well" means a well that is the sole source of water for a commercial facility that requires the water from the well for continued operation. Examples include wells serving an ice plant, a car wash facility, or as irrigation for commercial nurseries, or agricultural wells that provide water for livestock or irrigation.

"Commissioner" means the State Health Commissioner, who is the chief executive officer of the board, a deputy commissioner, or a subordinate who has been delegated powers in accordance with subdivision 2 of 12VAC5-630-90 of this chapter.

"Consolidated rock" means a formation consisting entirely of a natural rock formation that contains no soil and does not collapse against the well casing.

"Construction dewatering" means the process of draining an excavated area that is flooded with rain water or groundwater before construction can start.

"Construction of wells" means acts necessary to locate and construct private wells.

"Contaminated media" means soil, sediment, dredged material, or debris that, as a result of a release or human use, has absorbed or adsorbed physical, chemical, or radiological substances at concentrations above those consistent with nearby or undisturbed soil or natural earth materials.

"Controlled low strength material" or "flowable fill" means a slurry comprised of cement, water, and fine aggregate or filler (including coal ash, foundry sand, quarry fines, and baghouse dust in any combination).

"Cuttings" means the solid material, saturated or unsaturated, removed from a borehole drilled by rotary, percussion, or auger methods.

"Deep well ejector pump system" means a well that utilizes a casing adapter and a deep well ejector. These wells must maintain a constant vacuum to operate.

"Department" means the Virginia Department of Health.

"Deputy commissioner" means a person who serves as a deputy commissioner in accordance with § 32.1-22 of the Code of Virginia.

"DEQ" means the Virginia Department of Environmental Quality.

"Disinfection" means a process that inactivates or destroys pathogenic organisms in water by use of a disinfectant.

"Division" means the Division of On-Site Sewage and Water Services, Environmental Engineering, and Marina Programs within the department.

"District health department" means a consolidation of local health departments as authorized in § 32.1-31 C of the Code of Virginia.

"DPOR" means the Virginia Department of Professional and Occupational Regulation.

"Drilled shallow well suction pump system" means a drilled well two inches or smaller in diameter that utilizes an offset pump to draw water from the well through the casing. These wells must maintain a constant vacuum in order to operate.

"Drilled well" means a well that is excavated wholly or in part by means of a drill (either percussion or rotary) that operates by cutting or abrasion.

"Driven well" means a well that is constructed by driving a pipe, at the end of which there is a drive point and screen, without the use of a drilling, boring, or jetting device.

"Dug well" means a well that is excavated by means of picks, shovels, or other hand tools or by means of a power shovel or other dredging or trenching machinery, as distinguished from a bored, drilled, driven, or jetted well.

"Emergency well replacement" means the replacement of an existing private drinking water well, heat pump well, or commercially dependent well that has failed to deliver the water needed for its intended use. The failure requires the drilling of a new well or extensive modifications to the existing well. The replacement of failed noncommercial irrigation wells and other types of private wells are not considered emergencies.

"Gravel pack" means sand or gravel placed outside a well screen in a well to assist the flow of water into the well screen and to inhibit clogging of the screen.

"Groundwater" means water, except capillary moisture, beneath the land surface in the zone of saturation or beneath the bed of a stream, lake, reservoir or other body of surface water within the boundaries of this Commonwealth, whatever may be the subsurface geologic structure in which the water stands, flows, percolates, or otherwise occurs.

"Groundwater management area" means a geographically defined groundwater area in which the State Water Control Board has deemed the levels, supply, or quality of groundwater to be adverse to public welfare, health, and safety pursuant to 9VAC25-600.

"Grout" means a stable, impervious bonding material, reasonably free of shrinkage, that is capable of providing a watertight seal in the annular spaces of a water well throughout the depth required, to protect against the intrusion of objectionable matter.

"Human consumption" means drinking, food preparation, dishwashing, bathing, showering, hand washing, teeth brushing, and maintaining oral hygiene.

"Jetted well" means a well that is excavated using water pumped under pressure through a special washing point to create a water jet that cuts, abrades, or erodes material to form the well.

"Lead free" means the following:

1. When used with respect to solders and flux, refers to solder and flux containing not more than 0.2% lead.

2. When used with respect to pipes, pipe fittings, plumbing fittings, and plumbing fixtures, refers to the weighted average of wetted surfaces of pipes, pipe fittings, plumbing fittings, and plumbing fixtures containing not more than 0.25% lead.

"Local health department" means the department established in each city and county in accordance with § 32.1-30 of the Code of Virginia.

"Noncollapsing material" means soil or gravel material that can maintain an open well bore long enough to grout the annular space between a well and the well bore. For the purpose of this chapter, soil or gravel material that collapsed upon itself but created voids around the casing is considered noncollapsing material.

"Nonpublic water" means pure water that is not provided by a waterworks.

"Observation well" or "monitoring well" means a well constructed to measure hydrogeologic parameters or for scientific monitoring of the quality of groundwater, or for both purposes.

"Owner" means the Commonwealth or any of its political subdivisions, including sanitary districts, sanitation district commissions and authorities, an individual, a group of individuals acting individually or as a group, a public or private institution, corporation, company, partnership, firm, or association that owns or proposes to own or lease a private well.

"Person" means an individual, corporation, partnership, association, or any other legal entity.

"Pollutant" means substances, including solid waste, sewage, effluent, radioactive materials, petroleum products, manufactured chemical products, and industrial byproducts, that can detrimentally affect the quality of water.

"Private well" means a water well constructed for a person on land that is owned or leased by that person and is usually intended for household, groundwater source heat pump, agricultural use, industrial use, or other nonpublic water well.

"Pure water" means water of a quality suitable for human consumption that is (i) sanitary and normally free of minerals, organic substances, and toxic agents in excess of reasonable amounts and (ii) adequate in quantity and quality for the minimum health requirements of the persons served.

"Reclaimed water" means treated wastewater that can be used for beneficial purposes, determined by the degree of treatment achieved.

"Remediation well" means an observation or monitoring well in use for recovery or treatment of one or more pollutants.

"Replacement well" means a well being constructed to take the place of an existing well that is being taken out of service and is being abandoned.

"Sanitary survey" means an investigation of obvious sources of potentially toxic or dangerous substances within 200 feet of a proposed private well.

"Screen" means the intake section of a well casing that obtains water from an unconsolidated aquifer providing for the water to flow freely and adding structural support to the bore hole. Screens are used to increase well yield or prevent the entry of sediment, or both.

"Sewage" means water carried and nonwater carried human excrement, kitchen, laundry, shower, bath, or lavatory wastes separately or together with underground, surface, storm and other water and liquid industrial wastes as may be present from residences, buildings, vehicles, industrial establishments, or other places.

"Sewage disposal system" means a sewerage system or treatment works designed not to result in a point source discharge.

"Sewer" means a pipe or conduit used to convey sewage or industrial waste streams.

"Sewerage system" means pipelines or conduits, pumping stations and force mains, and all other construction, devices, and appliances appurtenant thereto used for the collection and conveyance of sewage to a treatment works or point of ultimate disposal.

"Subsurface soil absorption" means a process that utilizes the soil to treat and dispose of sewage effluent.

"Treatment works" means a device or system used in the storage, treatment, disposal, or reclamation of sewage or combinations of sewage and industrial wastes, including pumping, power, and other equipment and appurtenances, septic tanks, and works, including land, that are or will be (i) an integral part of the treatment process or (ii) used for the ultimate disposal of residues or effluents resulting from the treatment.

"Tremie pipe" means a tube through which grout, filter media, or other flowing material is placed by gravity feed or pumping. The pipe is placed at the lowermost part of the well feature being treated (inner casing or annular space), and the bottom of the pipe remains submerged in the material being placed as the pipe is raised in order to prevent uneven distribution or bridging.

"Variance" means a conditional waiver of a specific regulation that is granted to a specific owner relating to a specific situation or facility and may be for a specified time period.

"Water quality" means the chemical, physical, bacteriological, and radiological characteristics of water with respect to its suitability for a particular purpose.

"Water table" means the uppermost surface of groundwater saturation in an unconfined aquifer and the level in the saturated zone at which the pressure is equal to atmospheric pressure.

"Water well" or "well" means an artificial opening or artificially altered natural opening, however made, by which groundwater is sought or through which groundwater flows under natural pressure or is intended to be artificially drawn.

"Water well systems" means the water well to reach groundwater and the well pump and tank, including pipe and wire, up to and including the point of connection to plumbing and electrical systems.

"Water well systems provider" means the person certified by DPOR to provide the drilling, installation, maintenance, or repair of a water wells or water well systems.

"Waterworks" means a system that serves piped water for human consumption to at least 15 service connections or 25 or more individuals for at least 60 days out of the year. "Waterworks" includes all structures, equipment, and appurtenances used in the storage, treatment, and distribution of pure water except the piping and fixtures inside the building where the water is delivered.

"Well area" means an area designated on a construction permit as appropriate for the construction of a private well.

"Well bore" means a vertical hole advanced into the earth, however created, by a water well system provider, in which a well is constructed.

"Well site" means the location on the ground surface of a property designated on a construction permit for the construction of a private well.

"Work days" or "working days" means days on which the department, the district health department, or the local health department, as applicable in context, is open for business, excluding holidays and closures.

"Yield" means the quantity of water, usually measured in volume of water per unit of time, which may flow or which may be pumped, from a well or well field.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 1.1, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

Article 2 General Provisions

12VAC5-630-20 Authority for regulations

Title 32.1 of the Code of Virginia, and specifically §§ 32.1-12 and 32.1-176.2 of the Code of Virginia, provide that the board has the duty to protect the public health and to ensure that groundwater resources are not adversely affected by the construction and location of private wells. In order to discharge this duty, the board is empowered, pursuant to §§ 32.1-12 and 32.1-176.4 of the Code of Virginia, to regulate the construction and location of private wells within the Commonwealth.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 1.3, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-30 Purpose and applicability of regulations

A. Purpose. This chapter has been promulgated by the board to:

1. Ensure that all private wells are located, constructed, and maintained in a manner that does not adversely affect groundwater resources or the public welfare, safety, and health;

2. Guide the commissioner in determining whether a permit for construction of a private well should be issued or denied;

3. Guide the owner or the owner's agent in the requirements necessary to secure a permit for construction of a private well;

4. Guide the owner or the owner's agent in the requirements necessary to secure an inspection statement following construction; and

5. Guide the owner or the owner's agent in the requirements necessary to abandon a private well (temporarily or permanently) when the well is not in use.

B. Applicability. This chapter applies to owners of a private well. The following wells are excluded from the requirements of this chapter:

1. Wells constructed as a groundwater source for a waterworks as regulated by 12VAC5-590.

2. Wells constructed for the purpose of building, roadway, or other geotechnical foundation investigation, design, or construction, provided that the well, including an unimproved well bore, is abandoned in such a manner as to prevent it from being a channel of vertical movement of surface water or a source of contamination into the ground.

3. Wells constructed for the purpose of an elevator shaft.

4. Wells constructed for the purpose of constructing an extensometer or similar scientific instrument.

5. Wells constructed for the purpose of grounding of electrical apparatus.

6. Wells constructed for the purpose of the modification or development of springs.

7. Wells constructed for the purpose of underground injection as regulated by 40 CFR Part 144.

8. Wells constructed for the purpose of the observation or monitoring of groundwater elevation or quality, except as governed by 12VAC5-630-420 B and C.

9. Well bores, including direct push well bores and hand tool made well bores, advanced for the purpose of collecting soil or groundwater samples for analysis with or without temporary installation of casing or screen, provided that the well bore is abandoned after the sample is collected in such a manner as to prevent it from being a channel of vertical movement of surface water or a source of contamination into groundwater.

10. Wells constructed for the purpose of construction dewatering, provided that the well is abandoned within 60 days of construction by the removal of the well point, well casing, screening, and other appurtenances associated with the construction and operation of the well and completion of abandonment in such a manner as to prevent it from being a channel of vertical movement of surface water or a source of contamination into groundwater.

11. Wells constructed to provide cathodic protection, provided that the well is abandoned after use in such a manner as to prevent it from being a channel of vertical movement of surface water or a source of contamination into groundwater.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 1.3, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-40 (Repealed.)

History

• Historical Notes: Derived from VR355-34-100 § 1.4, eff. April 1, 1992; repealed, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-50 Relationship to the State Water Control Board

This chapter is independent of all regulations promulgated by the State Water Control Board. Groundwater users located in a groundwater management area may be required to obtain a permit from the State Water Control Board in addition to obtaining a permit from the Department of Health. In addition to the reporting requirements contained in this chapter, § 62.1-258 of the Code of Virginia requires that private wells constructed in a groundwater management area be registered by the water well systems provider with the State Water Control Board within 30 days of the completion of construction. Private wells constructed in groundwater management areas are subject to 9VAC25-610.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 1.5, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-60 Relationship to the Department of Environmental Quality

This chapter establishes minimum standards for the protection of public health and groundwater resources. Observation wells, monitoring wells, and remediation wells constructed under the supervision of DEQ are governed by 12VAC5-630-420.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 1.6, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-70 Relationship to the Uniform Statewide Building Code

This chapter is independent of and in addition to the requirements of the Uniform Statewide Building Code (13VAC5-63). Persons required to obtain a well permit by this chapter shall furnish a copy of the permit to the local building official, upon request, when making application for a building permit. Prior to obtaining an occupancy permit, an applicant shall furnish the local building official with a copy of the inspection statement demonstrating the water supply has been inspected, sampled and tested (when applicable), and approved by the district or local health department.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 1.7, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-80 Relationship to the Department of Professional and Occupational Regulation

Persons engaged in the construction, repair, or alteration of a private well shall be licensed and certified in accordance with §§ 54.1-1103 and 54.1-1129.1 of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 1.8, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-90 Administration of regulations

This chapter is administered by the following:

1. The board has the responsibility to promulgate, amend, and repeal regulations necessary to ensure the proper location, construction, repair, and abandonment of private wells.

2. The commissioner is the chief executive officer of the department. The commissioner has the authority to act within the scope of regulations promulgated by the board and for the board when it is not in session. The commissioner may delegate powers under this chapter in writing to a subordinate; however, the power to (i) issue variances under § 32.1-12 of the Code of Virginia and 12VAC5-630-170, and (ii) issue orders under § 32.1-26 of the Code of Virginia and 12VAC5-630-140 and 12VAC5-630-150 B may not be delegated.

The commissioner has final authority to adjudicate contested case decisions of subordinates delegated powers under this section prior to appeal of such case decisions to the circuit court.

3. The department is designated as the primary agent of the commissioner for the purpose of administering this chapter.

4. The district or local health departments are responsible for implementing and enforcing the regulatory activities required by this chapter.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 1.9, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-100 Right of entry and inspections

In accordance with the provisions of § 32.1-25 of the Code of Virginia, the commissioner or the commissioner's designee shall have the right to enter any property to ensure compliance with this chapter. In accordance with the provisions of § 32.1-176.6 of the Code of Virginia, the department has the authority to conduct such inspections as it may find reasonably necessary to ensure that the construction work conforms to applicable construction standards.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 1.10, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-110 Compliance with the Administrative Process Act

The provisions of the Virginia Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) shall govern the promulgation and administration of this chapter, including governing the procedures for rendering case decisions as defined in § 2.2-4001 of the Code of Virginia, and shall be applicable to the appeal of a case decision based upon this chapter.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 2.1, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-120 Powers and procedures of regulations not exclusive

The commissioner may enforce this chapter through means lawfully available.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 2.2, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-130 [Reserved]. (Reserved)

12VAC5-630-140 Emergency order

If an emergency exists, the commissioner may issue an emergency order as is necessary for preservation of public health, safety, and welfare or to protect groundwater resources. The emergency order shall state the reasons and precise factual basis upon which the emergency order is issued. The emergency order shall state the time period for which it is effective. Emergency orders will be publicized in a manner deemed appropriate by the commissioner. The provisions of 12VAC5-630-150 C and D shall not apply to emergency orders issued pursuant to this section.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 2.4, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-150 Enforcement of regulations

A. Notice. Subject to the exceptions in this section, whenever the commissioner or the district or local health department has reason to believe a violation of any of this chapter has occurred or is occurring, the alleged violator shall be notified. The notice shall be made in writing, shall be delivered personally or sent by certified mail, shall cite the regulation allegedly being violated, shall state the facts that form the basis for believing the violation has occurred or is occurring, shall include a request for a specific action by the recipient by a specified time, and shall state the penalties associated with such violation. The commissioner may deem it necessary to initiate criminal prosecution or seek civil relief through mandamus, injunction, or other appropriate remedy prior to giving notice.

B. Orders. Pursuant to the authority granted in § 32.1-26 of the Code of Virginia, the commissioner may issue orders to require an owner, or other person, to comply with the provisions of this chapter. The order shall be signed by the commissioner and may require:

1. The immediate cessation and correction of the violation;

2. Appropriate remedial action to ensure that the violation does not recur;

3. The submission to the commissioner for review and approval of a plan to prevent future violations to the commissioner for review and approval;

4. The submission of an application for a variance; or

5. Other corrective action deemed necessary for proper compliance with the chapter.

C. Hearing before the issuance of an order. Before the issuance of an order described in this section, a hearing must be held, with at least 30 days of notice by certified mail to the affected owner or other person of the time, place, and purpose thereof for the purpose of adjudicating the alleged violation of this chapter. The procedures at the hearing shall be in accordance with 12VAC5-630-180 A or B and the Virginia Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

D. Order; when effective. Orders issued pursuant to this section shall become effective not less than 15 days after mailing a copy thereof by certified mail to the last known address of the owner or person violating this chapter.

E. Compliance with effective orders. The commissioner may enforce orders. Should any owner or other person fail to comply with any order, the commissioner may:

1. Apply to an appropriate court for an injunction or other legal process to prevent or stop any practice in violation of the order;

2. Commence administrative proceedings to suspend or revoke the construction permit;

3. Request the Attorney General to bring an action for civil penalty, injunction, or other appropriate remedy; or

4. Request the Commonwealth's Attorney to bring a criminal action.

F. Not exclusive means of enforcement. Nothing contained in 12VAC5-630-140 or this section shall be interpreted to require the commissioner to issue an order prior to commencing administrative proceedings or seeking enforcement of regulations or statute through an injunction, mandamus, other appropriate remedy, or criminal prosecution.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 2.5, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-160 Suspension of regulations during disasters

If in the case of a man-made or natural disaster, the commissioner finds that certain regulations cannot be complied with and that the public health is better served by not fully complying with this chapter, the commissioner may authorize the suspension of the application of the chapter for specifically affected localities and institute a provisional regulatory plan until the disaster is abated.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 2.6, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-170 Variances

A. The commissioner may grant a variance to this chapter. The commissioner shall follow the appropriate procedures set forth in this section in granting a variance.

B. Requirements for a variance. The commissioner may grant a variance if a thorough investigation reveals that the hardship imposed by this chapter (may be economic) outweighs the benefits that may be received by the public, and that the granting of such a variance shall not subject the public to unreasonable health risks or jeopardize groundwater resources.

The commissioner shall not grant a variance for an improperly located Class IV well that was located pursuant to an express Class IV permit, as described under 12VAC5-630-260 and 12VAC5-630-270, if the improper location of the well is a result of the failure by the owner, the owner's agent, or the water well systems provider to provide complete or accurate information on the site plan submitted with the application or to install the well in accordance with the permit.

C. Application for a variance. Any owner who seeks a variance shall apply in writing within the time period specified in 12VAC5-630-210. The application shall be signed by the owner, addressed, and sent to the commissioner. The application shall include:

1. A citation to the section from which a variance is requested;

2. The nature and duration of the variance requested;

3. Any relevant analytical results, including results of relevant tests conducted pursuant to the requirements of this chapter;

4. The hardship imposed by the specific requirement of this chapter;

5. Statements or evidence why the public health and welfare as well as the groundwater resources would not be degraded if the variance were granted;

6. Suggested conditions that might be imposed on the granting of a variance that would limit the detrimental impact on the public health and welfare or groundwater resources;

7. Other information, if any, believed pertinent by the applicant; and

8. Other information that the district or local health department or commissioner may require.

D. Evaluation of a variance application.

1. The commissioner shall act on a variance request submitted pursuant to subsection C of this section within 60 calendar days of receipt of the request.

2. In the evaluation of a variance application, the commissioner shall consider the following factors:

a. The effect that the variance would have on the construction, location, or operation of the private well;

b. The cost and other economic considerations imposed by this requirement;

c. The effect that the variance would have on protection of the public health;

d. The effect that the variance would have on protection of groundwater resources;

e. Relevant analytical results, including results of tests conducted pursuant to the requirements of this chapter;

f. The hardship imposed by enforcing the specific requirements of this chapter;

g. Suggested conditions that might be imposed on the granting of a variance that would limit detrimental impact on the public health and welfare;

h. Other information, if any, believed pertinent by the applicant; and

i. Other factors as the commissioner may deem appropriate.

E. Disposition of a variance request.

1. The commissioner may deny an application for a variance by sending a denial notice to the applicant by certified mail. The notice shall be in writing and shall state the reasons for the denial.

2. If the commissioner proposes to grant a variance request submitted pursuant to subsection C of this section, the applicant shall be notified in writing of this decision. The notice shall identify the variance, any conditions to the variance, and private well covered and shall specify the period of time for which the variance will be effective. The effective date of a variance shall be as stated in the variance.

3. No owner may challenge the terms or conditions set forth in the variance after 30 calendar days have elapsed from the effective date of the variance.

F. Posting of variances. Variances granted to private wells are transferable from owner to owner unless otherwise stated, but not transferable to another private well. The variance shall be attached to the permit to which it is granted. The variance is revoked when the permit to which it is attached is revoked.

G. Hearings on disposition of variances. Subject to the time limitations specified in 12VAC5-630-210, hearings on denials of an application for a variance or on challenges to the terms and conditions of a granted variance may be held pursuant to subdivision 1 or 2 of 12VAC5-630-180, except that informal hearings under subdivision 1 of 12VAC5-630-180 shall be held by the commissioner or the commissioner's designee.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 2.7, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-180 Hearing types

Hearings before the commissioner or the commissioner's designees shall include any of the following forms depending on the nature of the controversy and the interests of the parties involved.

1. Informal hearings. An informal fact-finding proceeding is an informal conference between the department and the named party held in accordance with § 2.2-4019 of the Code of Virginia. The department shall consider all evidence presented at the meeting that is relevant to the issue in controversy. Presentation of evidence, however, is entirely voluntary. No verbatim record need be taken at the informal hearing. The department shall review the facts presented and based on those facts render a decision. If the decision is adverse to the interests of the appellant, an aggrieved appellant may request an adjudicatory hearing pursuant to subdivision 2 of this section.

2. Adjudicatory hearing. The adjudicatory hearing is a formal, public adjudicatory proceeding conducted pursuant to § 2.2-4020 of the Code of Virginia.

The commissioner shall designate a hearing officer to conduct the hearing as provided in § 2.2-4024 of the Code of Virginia and to make written recommended findings of fact and conclusions of law. The final decision shall be reduced to writing and will contain the explicit findings of fact upon which the decision is based. Certified copies of the decision shall be delivered to the owner affected by it. Notice of a decision will be served upon the parties and become a part of the record. Service may be by personal service or certified mail return receipt requested.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 2.8, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024; Volume 42, Issue 5, eff. November 19, 2025.

12VAC5-630-190 Request for hearing

A request for an informal hearing shall be made by sending the request in writing to the district or local health department. A request for an adjudicatory hearing shall be made in writing and directed to the commissioner. Requests for hearings shall cite the reason for the hearing request and shall cite any section of this chapter involved.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 2.9, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-200 Hearing as a matter of right

An owner or other person whose rights, duties, or privileges have been or may be affected by a decision of the board or its subordinates in the administration of this chapter shall have a right to both informal and adjudicatory hearings. The commissioner may require participation in an informal hearing before granting the request for a full adjudicatory hearing. No person other than an owner shall have the right to an adjudicatory hearing to challenge the issuance of either a construction permit or inspection statement unless the person can demonstrate at an informal hearing that the minimum standards contained in this chapter have not been applied and that the person will be injured in some manner by the issuance of the permit or that groundwater resources will be damaged by the issuance of the permit.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 2.10, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-210 Appeals

An appeal from a denial, revocation, or voidance of a construction permit, inspection statement, or request for variance for a private well must be made in writing and received by the department within 30 days of the date of the denial, revocation, or voidance.

Pursuant to the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) an aggrieved party may appeal a final decision of the commissioner to an appropriate circuit court.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 2.11, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-220 Permits and inspection statement; general

A. All private wells shall be constructed and located in compliance with the requirements as set forth in this chapter.

B. After November 6, 2024, no person shall construct, alter, abandon, or increase the depth of a private well or allow the construction, alteration, abandonment, or activity to increase the depth of a private well without a written construction permit from the commissioner. Conditions may be imposed on the issuance of a permit and no private well shall be constructed or modified in violation of those conditions. The replacement of a well pump, the replacement of a well seal or cap with an equivalent well seal or cap, or the vertical extension of the well casing above the ground surface shall not be considered a well alteration.

C. Except as provided in 12VAC5-630-320, no person shall place a private well in operation or cause or allow a private well to be placed in operation without obtaining a written inspection statement pursuant to 12VAC5-630-310 and 12VAC5-630-330.

D. Except as provided in 12VAC5-630-270, 12VAC5-630-290, and 12VAC5-630-300, construction permits for a private well shall be deemed valid for a period of 18 months from the date of issuance, with provision for one 18-month renewal.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 2.12, eff. April 1, 1992.

12VAC5-630-230 Procedures for obtaining a construction permit for a private well

A. Construction permits are issued by the authority of the commissioner. Requests for a private well construction permit shall be by written application, signed by the owner or the owner's agent, and shall be directed to the district or local health department. Applications shall be made on an application form provided by the district or local health department and approved by the commissioner.

B. An application shall be deemed completed upon receipt by the district or local health department of a signed and dated application, together with the appropriate fee, containing the following information:

1. The property owner's name, address, and telephone number;

2. The applicant's name, address, and telephone number (if different from subdivision 1 of this subsection);

3. A statement signed by the property owner, or the owner's agent, granting the department access to the site for the purposes of evaluating the suitability of the site for a well and allowing the department access to inspect the well after it is installed;

4. A statement indicating whether the adjacent property is used for an agricultural operation;

5. Information required per 12VAC5-630-380 E if necessary.

6. A site plan showing the proposed well site, property boundaries, accurate locations of actual or proposed sewage disposal systems, recorded easements, and other sources of contamination within 100 feet of the proposed well site, and at the option of the applicant a proposed well design; and

7. When deemed necessary because of geological or other natural conditions, plans and specifications detailing how the well will be constructed.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 2.13, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-240 Issuance of the construction permit

A. A construction permit shall be issued to the owner by the commissioner no later than 60 days after receipt of a complete application submitted under 12VAC5-630-230 that meets requirements for issuance of the permit. If applicable, the applicant shall comply with 12VAC5-630-340 prior to issuance of the permit.

B. The permit shall indicate a well site or a well area.

1. A well site shall be designated as a specific location that can be identified on the property by means of measurement from identified fixed points on the property.

2. A well area may be designated as a polygon or as a defined radius around a proposed well site. The well area shall be described in sufficient detail that it can be identified on the property by means of measurement from identified fixed points on the property.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 2.14, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-250 Emergency procedures

Applications for replacement wells that meet the definition of an emergency well replacement (12VAC5-630-10) shall have priority over normal applications for private well permits. Emergency procedures are as follows:

1. Drinking water wells. When a private drinking water well has failed and must be replaced, a licensed onsite soil evaluator, professional engineer, or licensed water well systems provider shall conduct a sanitary survey of the property and surrounding area to determine the most suitable location. If a site is found that meets the minimum site requirements of this chapter, including the minimum separation distances contained in Table 1 of 12VAC5-630-380 and 12VAC5-630-380 H, the local health department will issue a permit for that site. If a site cannot be located that meets the minimum separation distances listed in Table 1 of 12VAC5-630-380 and 12VAC5-630-380 H, the local health department shall identify a site that complies with the minimum separation distances to the greatest extent possible. However, the replacement well shall not be located closer to a source of contamination than the existing well it is replacing. Replacement drinking water wells must meet the sampling requirements of 12VAC5-630-431 E and F.

2. Heat pump wells or commercially dependent wells. If a heat pump well or commercially dependent well must be replaced, the applicant shall propose a replacement site based on the technical requirements of the heat pump system or commercial establishment. A licensed onsite soil evaluator, professional engineer, or water well systems provider shall conduct a sanitary survey of the property and surrounding area to determine the most suitable location. If the site meets the minimum requirements of this chapter, the local health department will issue a permit for that site. If a site cannot be located that meets the minimum separation distances listed in Table 1 of 12VAC5-630-380, the local health department shall identify a site that complies with the minimum separation distances to the greatest extent possible. However, the replacement well shall not be located closer to a source of contamination than the existing well it is replacing. If the replacement heat pump well or commercially dependent well must be placed closer to a sewage disposal system (but no closer than the existing well it is replacing) the well shall be sampled for fecal coliforms. If fecal coliforms are present in the sample and further investigation reveals that the groundwater is contaminated, the well shall be abandoned.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 2.15, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-260 Express Class IV construction permits

A. When a Class IV well is proposed for property that does not have an onsite sewage disposal system, either active or inactive, an application may be made for an express Class IV construction permit. An application for an express Class IV construction permit shall be made on a form provided by the district or local health department and approved by the commissioner.

B. An application shall be deemed completed upon receipt by the district or local health department of a signed and dated application, together with the appropriate fee, containing the following information:

1. The property owner's name, address, telephone number, and personal signature. The owner's signature will acknowledge that the permit will be issued without the benefit of a site visit by the local health department prior to the issuance of the construction permit; that the permit is being issued based upon the information provided on the accompanying site plan; that the property owner also acknowledges that if the well is found not to comply with the minimum separation distances or other provision of this chapter, the well must be abandoned at the direction of the local or district health director; and that a variance will not be considered if the improper location of the well is a result of the failure by the owner, the owner's agent, or the water well systems provider to provide complete or accurate information on the site plan submitted with the application or to install the well in accordance with the permit;

2. Address and directions to the property;

3. The proposed use of the well;

4. The name, address, telephone number, license number, and signature of the water well systems provider who is to construct the well;

5. A statement signed by the property owner (and not the owner's agent) granting the department access to the site for the purposes of inspecting the property and the well during and after its installation until the well is approved by the department or a required abandonment is completed; and

6. A site plan showing the proposed well site, property boundaries, recorded easements, and accurate locations of actual or proposed sources of contamination (including those listed in Table 1 of 12VAC5-630-380) within 100 feet of the proposed well site, and at the option of the applicant a proposed well design. If the proposed well site is located on or at the base of sloping topography, the minimum separation distances shown on the site plan for sources of contamination within a 60 degree arc slope of the proposed well site must be increased 25 feet for every 5.0% slope.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 2.16, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-270 Issuance of express Class IV construction permits and final inspection

A. Issuance of express Class IV construction permit. Upon receipt of a complete and approvable application, as defined in 12VAC5-630-260, by a local or district health department with multiple environmental health specialists, the department shall exercise due diligence to issue a permit either on the date of receipt or the following business day. If the local or district office has only one assigned environmental health specialist, the local or district department will exercise due diligence to issue the permit as soon as possible. Failure by the department to issue the permit within the specified time does not authorize the construction of the well without a permit. If applicable, the applicant shall comply with 12VAC5-630-340 prior to the issuance of the permit.

B. Validity of express Class IV construction permits. Express Class IV construction permits shall only be valid for a period of 30 days from the date of issuance.

C. Inspection. If, upon inspection of the well, it is found that the well location does not comply with the minimum separation distances or other provisions of this chapter, no inspection statement shall be issued and the well shall be immediately abandoned by the property owner in accordance with 12VAC5-630-450 upon notification and direction by the local or district health director. The commissioner shall not grant a variance if the improper location of the well is a result of the failure by the owner, the owner's agent, or the water well systems provider to provide complete or accurate information on the site plan submitted with the application or to install the well in accordance with the permit.

The construction of the well shall also comply with this chapter.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 2.17, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-271 Express geothermal well permits

A. The issuance of an express geothermal permit is contingent upon proper registration and payment of application fees and applies to the construction of wells used solely for a closed-loop geothermal heating system.

B. A single application and a single fee are required for any geothermal well system. The fee is the same as for a single private well. A registration statement for closed loop construction permitting shall be made on a form provided and approved by the division. The registration shall include the following information:

1. The property owner's name, address, and telephone number;

2. The address of and directions to the property;

3. The proposed use of the well;

4. The name, address, telephone number, and contractor license number of the water well systems provider;

5. A statement signed by the property owner granting the department access to the site for the purpose of inspecting the property and the well during and after the well installation until the well is approved by the department or required corrections are made;

6. A site plan, drawn to scale, showing the proposed well site, property boundaries, recorded easements, and accurate locations of actual or proposed sources of contamination (including those listed in Table 1 of 12VAC5-630-380) within 100 feet of the proposed well site; and

7. A statement signed by the licensed water well systems provider that the location and construction of the well will comply with the requirements of this chapter.

C. A single application fee is required for any geothermal well system, regardless of the number of wells included in the system. The fee is the same as for a single private well.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 22, eff. August 16, 2012; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-272 Issuance of express geothermal well construction permit, inspection, and final approval

A. Issuance of the express geothermal well permit. Upon receipt of a complete registration statement and the appropriate fee, the department will acknowledge receipt of the registration statement and issue the permit with a copy given to the contractor. The construction of the geothermal heating system may begin immediately upon submission of a complete registration statement and counter-signature denoting receipt by the department.

B. Inspection. The department, at its sole discretion, may inspect the closed-loop geothermal well from after acceptance of the registration statement until after the installation is approved. If, upon inspection of the well, it is found that the well location does not comply with the minimum separation distances or other provisions of this chapter, no inspection statement shall be issued until the deficiencies have been corrected.

C. Final approval. Upon receipt of the Uniform Water Well Completion Report and completion of inspections deemed necessary to ensure compliance with this chapter, unless the department has evidence to indicate that the well is not in compliance with the requirements of this chapter, the local health department will provide the owner with a statement that the wells are approved for use.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 22, eff. August 16, 2012; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-280 Denial of a construction permit

If it is determined that (i) the proposed design is inadequate; (ii) site, geological, hydrological, or other conditions exist that do not comply with this chapter or would preclude the safe and proper operation of a private well system; (iii) the installation of the well would create an actual or potential health hazard or nuisance; or (iv) the proposed design would adversely impact the groundwater resource, the permit shall be denied and the owner shall be notified in writing, by certified mail, of the basis for the denial. The notification shall also state that the owner has the right to appeal the denial.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 2.18, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-290 Revocation of construction permits or inspection statements

In accordance with 12VAC5-630-331, the commissioner may revoke a construction permit or inspection statement for any of the following reasons:

1. Failure to comply with the conditions of the permit;

2. Violation of this chapter for which no variance has been issued;

3. Facts become known which reveal that a potential health hazard would be created or that the groundwater resources may be adversely affected by allowing the proposed well to be installed or completed.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 2.19, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-300 Voidance of construction permits

A. In accordance with 12VAC5-630-331, the commissioner has authority to declare well construction permits or inspection statements null and void when (i) conditions such as house location, sewage system location, sewerage system location, topography, drainage ways, or other site conditions are changed from those shown on the application or (ii) conditions are changed from those shown on the construction permit.

B. Construction permits are null and void when more than 18 months elapse from the date the permit was issued or renewed. Reapplication for the purposes of having an expired permit reissued shall be the responsibility of the owner, and reapplication shall be handled as an initial application and comply with 12VAC5-630-230.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 2.20, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-310 Statement required upon completion of construction

Within 30 days of completion of the construction, alteration, abandonment, or deepening of a private well, the owner, the owner's agent, or water well systems provider shall furnish the district or local health department a completed uniform water well completion report. The uniform water well completion report shall be signed by the water well systems provider and state that the well was installed, constructed, or abandoned in accordance with the permit, and that the well complies with applicable state and local regulations, ordinances, and laws.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 2.21, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-320 Inspection and correction

No well shall be placed in operation, except for the purposes of testing the mechanical soundness of the system, until inspected by the district or local health department, corrections are made if necessary, and the owner has been issued an inspection statement by the district or local health department.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 2.22, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-330 Issuance of the inspection statement

Upon satisfactory completion of the requirements of 12VAC5-630-310, 12VAC5-630-320, 12VAC5-630-340, 12VAC5-630-370, and 12VAC5-630-430, the commissioner shall issue an inspection statement to the owner. The issuance of an inspection statement does not denote or imply a warranty or guarantee of the water quality or quantity by the department or that the private well will function for a specified time. It shall be the responsibility of the owner or subsequent owner to maintain, repair, replace, or to comply with the requirements to abandon a private well.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 2.23, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-331 Enforcement, notices, informal conferences

A. The commissioner may, after providing a notice of intent to revoke a construction permit or inspection statement, and after providing an opportunity for an informal conference in accordance with § 2.2-4019 of the Code of Virginia, revoke or declare null and void a construction permit or inspection statement for flagrant or continuing violation of this chapter. Any person to whom a notice of revocation or null and void is directed shall immediately comply with the notice. Upon revocation, the former construction permit or inspection statement holder shall be given an opportunity for appeal of the revocation in accordance with the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

B. The commissioner may summarily suspend an inspection statement to operate a private well if continued operation constitutes a substantial and imminent threat to public health. Upon receipt of such notice that an inspection statement is suspended, the well owner shall cease private well operations immediately. Whenever an inspection statement is suspended, the holder of the inspection statement shall be notified in writing by certified mail or by hand delivery. Upon service of notice that the inspection statement is immediately suspended, the former inspection statement holder shall be given an opportunity for an informal conference in accordance with § 2.2-4019 of the Code of Virginia. The request for an informal conference shall be in writing and shall be filed with the local health department by the former holder of the inspection statement. If written request for an informal conference is not filed within 10 working days after the service of notice, the suspension is sustained. Each holder of a suspended permit shall be afforded an opportunity for an informal conference within three working days of receipt of a request for the informal conference. The commissioner may end the suspension at any time if the reasons for the suspension no longer exist.

C. Any person affected by a determination issued in connection with the enforcement of this chapter may challenge such determination in accordance with the provisions of the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

D. All private wells shall be constructed, operated, and maintained in compliance with the requirements as set forth in this chapter. The commissioner may enforce this chapter through any means lawfully available pursuant to § 32.1-27 of the Code of Virginia, and nothing in this chapter shall be construed as preventing the commissioner from making efforts to obtain compliance through warning, conference, or any other appropriate enforcement means.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-340 Requirement for easement

Whenever a private well subject to this chapter is proposed to be installed on property other than the owner's, an easement in perpetuity shall be recorded with the clerk of the circuit court prior to issuance of a construction permit. The easement shall be of sufficient area to permit access, construction, placement of the water line, and maintenance of the well.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 2.24, eff. April 1, 1992.

12VAC5-630-350 General

This chapter does not apply to private wells constructed, altered, or abandoned prior to September 1, 1990, unless such private well is subsequently altered or abandoned after September 1, 1990, in which case such alteration or abandonment shall be performed in accordance with this chapter.

The class of well to be constructed shall be determined by the local or district health department or the division.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 3.1, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-360 Classes of water wells

Classes of private wells established for purposes of this chapter are in addition to those established in the current Waterworks Regulations (12VAC5-590) and are intended for use for private well systems:

1. Class III - Private wells constructed to be used as a source of drinking water. There are three subclasses:

a. Class IIIA - Drilled wells in which the annular space around the casing is grouted to a minimum depth of 20 feet.

(1) The well shall be drilled and cased to a depth of at least 100 feet.

(2) The cased drill hole shall pass through at least 50 feet of collapsing material such as caving sand, gravel, or other material that will collapse against the casing.

b. Class IIIB - Drilled wells in which the casing is installed to a minimum depth of 50 feet and the annular space around the casing is grouted to at least 50 feet.

c. Class IIIC - Drilled, bored, driven, or jetted wells other than Class IIIA and Class IIIB.

2. Class IV - Private wells constructed for a purpose other than use as a source of drinking water. There are three subclasses:

a. Class IVA - Drilled wells in which the annular space around the casing is grouted to a minimum depth of 20 feet.

(1) The well shall be drilled and cased to a depth of at least 100 feet.

(2) The cased drill hole shall pass through at least 50 feet of collapsing material such as caving sand, gravel, or other material that will collapse against the casing.

b. Class IVB - Drilled wells in which the casing is installed to a minimum depth of 50 feet and the annular space around the casing is grouted to at least 50 feet.

c. Class IVC - Drilled, bored, driven, or jetted wells other than Class IVA and Class IVB.

3. Conversion of well class. A Class IV well may be converted to a corresponding Class III well provided the well meets (i) the location and construction standards set forth in this chapter and the water quality standards set forth in 12VAC5-630-431 and (ii) a construction permit application and a revised uniform water well completion report form are submitted to the department.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 3.2, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-370 (Repealed.)

History

• Historical Notes: Derived from VR355-34-100 § 3.3, eff. April 1, 1992; repealed, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-380 Well location

A. The private well shall be sited for the protection of public health and the aquifer, with appropriate consideration given to distance from potential contamination sources; vulnerability to known or suspected natural risks (e.g., flooding); potential for interference with utilities; accessibility for drilling machinery and support equipment; and safety of the public and well construction personnel.

B. Sanitary survey. Obvious sources of potentially toxic or dangerous substances within 200 feet of the proposed private well shall be investigated as part of the sanitary survey. Sources of contamination may include items listed in Table 1; abandoned wells; pesticide treated soils; petroleum or chemical storage tanks, drums, totes, or other storage containers (aboveground and underground); and other sources of physical, chemical, or biological contamination. If the source of contamination could affect the well adversely, and preventive measures are not available to protect the groundwater, the well shall be prohibited. The minimum separation distance between a private well and structures, topographic features, or sources of pollution shall comply with the minimum distances shown in Table 1.

| TABLE 1 SEPARATION DISTANCES (IN FEET) BETWEEN A WELL AND A STRUCTURE OR TOPOGRAPHIC FEATURE | | | | | | | --- | --- | --- | --- | --- | --- | | Feature | Minimum Separation Distance | Exceptions | | | | | | Class IIIA/B | Class IIIC | Class IVA/B | Class IVC | | | 1. Building foundation | 15 | 15 | 15 | 15 | 10 feet if structure is treated with borate based termite treatment | | 2. House sewer line a. Constructed of cast iron pipe with water-tight caulked joints; mechanical joints using neoprene gaskets; or solvent welded Schedule 40 or better PVC pipe – provided the well is cased and grouted to water bearing formation | 10 | 10 | 10 | 10 | None | | b. Other or unknown construction; or if well is not cased and grouted to water bearing formation | 50 | 50 | 50 | 50 | None | | 3. Sewer main, including force main a. Constructed of ductile iron pipe with water-tight joints; solvent welded Schedule 40 or better PVC (SDR-35 plastic PVC with neoprene gaskets) – provided the well is cased and grouted to water bearing formation | 35 | 35 | 35 | 35 | None | | b. Other or unknown construction; or if well is not cased and grouted to water bearing formation | 50 | 50 | 50 | 50 | None | | 4. Sewerage system | 50 | 50 | 50 | 50 | None | | 5. Active or permitted pretreatment system (e.g., septic tank or aerobic unit) | 50 | 50 | 50 | 50 | None | | 6. Active or permitted drainfield (including reserve drainfield). | 50 | 100 | 50 | 100 | None | | 7. Other contamination source (e.g., petroleum storage tank, drum, tote or other container aboveground or underground, barnyard, landfill, animal lot, fertilizer or pesticide storage) | 50 | 100 | 50 | 100 | Tanks containing propane or other liquified petroleum gases are not deemed sources of contamination. However, the National Fire Protection Association Liquified Petroleum Gas Code (NFPA-58) recommends a minimum of 10 feet from sources of ignition. | | 8. Permanently abandoned sewage disposal systems | 25 | 25 | 25 | 25 | None | | 9. Reclaimed water distribution pipeline | 50 | 50 | 50 | 50 | 35 feet if RWDP is constructed of water pipe material in accordance with 9VAC25-740-110. | | 10. Biosolids application fields (as field is defined in 9VAC25-32-10) | 100 | 100 | 100 | 100 | No separation distance applies if biosolids have not been applied within the 12 months preceding well construction. | | 11. Bioretention pond a. Unlined | 50 | 50 | 50 | 50 | | | b. Lined | 10 | 10 | 10 | 10 | | | 12. Cemetery | 50 | 100 | 50 | 100 | None | | 13. Sewage dump station | 50 | 100 | 50 | 100 | None | | 14. Property line a. All properties except as described in subdivision 14 b of this table | 5 | 5 | 5 | 5 | None | | b. With an adjacent property of three acres or larger used for an agricultural operation as defined in § 3.2-300 of the Code of Virginia. | 50 | 50 | 50 | 50 | Exemption for reduced distance applies if the adjacent property owner grants written permission for construction within 50 feet of the property line, or if it is certified that no other site on the property complies with the regulations for construction of a private well. |

C. Downslope siting of wells from potential sources of pollution. Special precaution shall be taken when locating a well within a 60 degree arc directly downslope an existing or intended onsite sewage disposal system or other known source of pollution identified in subsection B of this section, including Table 1. The minimum separation distance shall be (i) increased by 25 feet for every 5.0% of slope or (ii) an increase shall be made to the minimum depth of grout and casing in the amount of five feet for every 5.0% of slope.

D. Sites in areas subject to flooding. No private well covered by this chapter shall be located in areas subject to the collection of pollutants such as swampy areas, low areas, or areas subject to flooding. Wells located in flood plains shall be adequately constructed so as to preclude the entrance of surface water during flood conditions. At a minimum, such construction will include extending the well terminus 18 inches above the annual flood level and grading to provide positive drainage in all directions. Other requirements may be made as determined on a case-by-case basis by the division.

E. Property lines. The owner is responsible for establishing a separation distance from property lines such that the construction and location of the well will be on the owner's property and comply with any local ordinances. No private well shall be constructed within five feet of a property line. If the proposed private well is on a property adjoining properties of three acres or larger used for an agricultural operation, no private well shall be constructed within 50 feet of the property line except as exempted by the following:

1. A notarized letter from the adjacent property owner that grants permission to construct a well within 50 feet of the property line. The statement shall be recorded and indexed in the land records of the circuit court having jurisdiction over the property where the well is to be located; or

2. A certification statement from a licensed onsite soil evaluator, professional engineer, or licensed water well systems provider confirms that no other well location on the property complies with this chapter. Reasons that a well location on a property may not comply with this chapter include:

a. The property is not large enough to allow a location of a well 50 feet or more from the property line. In this case, the well should be located at the greatest distance from the property line consistent with this chapter.

b. The location of a well 50 feet or more from the property line prevents separation distance requirements identified in 12VAC5-630-380 B being achieved on the property, provided that required separation distances can be achieved if the well is located fewer than 50 feet from the property line. In this case, the well should be located at the greatest distance from the property line consistent with this chapter. Well owners shall not be obligated to undertake otherwise optional actions, such as substitution of an alternative onsite sewage system in place of a conventional system where a conventional system is suitable, solely to comply with the requirement to maintain a 50-foot separation distance from an adjoining property of three acres or larger used for an agricultural operation.

c. The location is inaccessible to well drilling equipment as a result of topography, surface water, structures, existing onsite sewage system components, overhead or buried utilities, or other obstacle.

d. Other reasons that a well located greater than 50 feet from the property line may not comply with this chapter may be considered by the division on a case-by-case basis.

F. Utility lines. There is no minimum separation distance between a private well and subsurface utility lines (electric, gas, water, cable, etc.). The minimum separation distance may, however, be established by the individual utility company or local ordinance. Clearance distance from overhead electrical utilities relative to drilling equipment is subject to an Occupational Safety and Health Administration or related safety standard, and this factor shall be considered in determination of well location. No private well shall be constructed within a utility easement without documentation of permission from the utility.

G. Permanently abandoned sewage disposal systems.

1. No private well shall be constructed within 25 feet of a permanently abandoned sewage disposal system. The following criteria is to determine if a sewage disposal system is permanently abandoned.

a. The drainfield is no longer connected to a structure or other sewage source.

b. The drainfield has been inactive for at least 24 consecutive months.

c. The septic tank and distribution box have been pumped, limed, crushed, and either filled with an inert material or removed from the site.

2. Documentation of disconnection may include:

a. A statement from the owner of the drainfield.

b. A notification of onsite sewage system abandonment recorded and indexed in the grantor index of the land records of the circuit court having jurisdiction over the site where the sewage system is located.

c. A contractor invoice or other record documenting system disconnection, including disposition of septic tank and distribution box.

d. Record from a public sewer operator indicating date of connection.

3. Abandoned sewage disposal systems that do not meet the requirements of this subsection shall be treated as active systems with respect to determining the minimum separation distance to sources of contamination listed in Table 1.

H. Reclaimed water distribution pipeline. No private well shall be placed closer than 50 feet from a reclaimed water distribution pipeline. This separation distance can be reduced to 35 feet provided that the reclaimed water distribution pipeline is constructed from a water pipe material in accordance with American Water Works Association (AWWA) specifications and pressure tested in place without leakage prior to backfilling. The hydrostatic test shall be conducted in accordance with the AWWA standard (ANSI/AWWA C-600-05) for the pipe material, with a minimum test pressure of 30 psi. A Class IV well located closer than 35 feet from a reclaimed water distribution pipeline shall not be converted to a Class III well.

I. Biosolids application field. No private well shall be placed closer than 100 feet from a field, as defined in 9VAC25-32-10, on which biosolids are being applied or have been applied within the previous 12 months.

J. Bioretention pond. No private well shall be placed closer than 50 feet from an unlined bioretention pond or 10 feet from a lined bioretention pond. A Class IV well shall not be converted to a Class III well if the Class III well separation distance is not met.

K. Exception for closed-loop ground-source heat pump wells. Closed-loop ground-source heat pump wells, depending upon construction, may not have to comply with the minimum separation distances for Class IV wells listed in Table 1. If the well is grouted 20 feet, the minimum separation distances must comply with those listed for Class IV wells. If the well is grouted a minimum of 50 feet, the separation distances shall be those listed for Class IIIA or IIIB wells. If the well is grouted the entire depth of the well, the well does not have to comply with the minimum separation distances contained in Table 1.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 and 32.1-176.5:2 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 3.4, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-390 Site protection

A. No objects, articles, or materials that are not essential to the operation of the well shall be placed or stored in a well, well house, on the well head or well pump or water treatment system, or within close proximity to them.

B. Fencing of an area around the well, or the placement of other barriers or restrictions, may be required as a condition of the permit under certain circumstances, such as to prohibit livestock access to the well head or to prohibit vehicles from damaging or polluting the area around the well head.

C. The area around the well shall be graded to divert surface water away from the well.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 3.5, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-400 Materials

A. General. Materials used in private wells shall be lead free, labeled as approved by the National Sanitation Foundation (NSF) for water well use, have long-term resistance to corrosion and sufficient strength to withstand hydraulic, lateral, and bearing loads.

B. Drilling Fluids. Materials used for well bore stabilization and well development shall be labeled as meeting NSF/ANSI/CAN Standard 60-2020 environmental specifications.

C. Casing. Materials used for casing shall be watertight and shall consist of wrought iron, concrete tile, clay tile, steel, stainless steel, fiberglass, or plastic, all designed for water well use. Materials used for casing shall be labeled as conforming to NSF/ANSI/CAN 61-2021 (Drinking Water System Components – Health Effects) and NSF/ANSI/CAN 372-2020 (Drinking Water System Components – Lead Content).

1. Driven casings shall consist of ductile iron, steel, or stainless steel and shall be equipped with a suitable drive boot.

2. Casings used for drilled wells shall be steel, stainless steel, plastic, or fiberglass.

3. Casings used for bored Class IIIC and IVC wells shall be concrete.

D. Screens. Where utilized, screens shall be factory manufactured of stainless steel, plastic, or other suitable materials. Screens shall be constructed of materials that will not be damaged by chemical or corrosive action of the groundwater or future cleaning operations. Additionally, screens shall be constructed of materials that will not degrade groundwater quality. Allowable screen types include wire wrap, louvered, bridge slot, and factory slotted and shall be labeled as conforming to NSF/ANSI/CAN 61-2021 (Drinking Water System Components – Health Effects) and NSF/ANSI/CAN 372-2020 (Drinking Water System Components – Lead Content).

E. Grout. The grouting material used shall meet the appropriate specification listed in this subsection.

1. Neat cement grout shall consist of cement and water with not more than six gallons of water per bag (94 pounds) of cement.

2. Bentonite clay may be used in conjunction with neat Portland cement to form a grouting mixture. The bentonite used must be specifically recommended by the manufacturer as being suitable for use as a well grout material and cannot exceed 6.0% by weight of the mixture.

3. Bentonite clay used for grouting shall be sodium bentonite with a minimum of 20% clay solids by weight of water. The bentonite clay shall be specifically recommended by the manufacturer for use as a grouting material.

An exception exists (i) when exceptional conditions require the use of a less fluid grout, to bridge voids, a mixture of cement, sand and water in the proportion of not more than two parts by weight of sand to one part of cement with not more than six gallons of clean water per bag of cement may be used if approved by the district or local health department, or (ii) for bored wells only, a concrete (1-part sand, 1-part cement, 2-parts pea gravel mix with all aggregates passing a 1/2-inch sieve) grout with not more than six gallons of clean water per bag of cement may be used provided a minimum three-inch annular space is available.

4. Other grouting materials may be approved by the division on a case-by-case basis. Review and approval shall be based on whether the proposed material can consistently be expected to meet the intent of grouting expressed in 12VAC5-630-410 F 2. The proposed material must be an industry acceptable material used for the purpose of grouting water wells. Controlled low strength material (flowable fill) or other product incorporating fly ash, other coal combustion byproducts, or other wastes shall not be approved for use as grout.

F. Gravel and sand utilized for filter packed wells shall be uniformly graded, cleaned, washed, disinfected, well rounded, acid resistant, and have a high silica content.

G. Water used during well construction shall be obtained from a suitable source or the well being constructed. A suitable source means a pure water source, or, when a pure water source is not locally available, water taken from another source then disinfected using compounds labeled as meeting NSF/ANSI/CAN Standard 60-2020 environmental specifications.

H. Compounds used in the disinfection of completed wells shall be labeled as meeting NSF/ANSI/CAN Standard 60-2020 environmental specifications.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 3.6, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-410 Construction; general

A. Private wells shall be constructed using the criteria described in this section. The water well system provider shall provide advance notification regarding the initiation of well construction to the district or local health department to allow department personnel the opportunity to observe well construction. The water well systems provider may construct the well as conditions warrant and shall be under no obligation to delay construction activities pending arrival of district or local health department personnel.

B. Well bore.

1. The method of advancement of the well bore in which the private well is constructed shall be determined by the water well systems provider relative to local geologic and aquifer conditions.

2. When the construction permit designates a well site, the well bore shall be placed at the well site. When the construction permit designates a well area, the well bore may be placed anywhere within the well area. If a well bore advanced within a well area must be discontinued for any reason, the well bore shall be abandoned in accordance with 12VAC5-630-450 and a new well bore may be undertaken within the well area.

3. Other land disturbance associated with well construction, such as grading and mud pit construction, is not limited to the well area.

4. With the exception of driven wells, the well bore shall be large enough to accommodate the well casing and screen with sufficient annular space on all sides of the casing in the interval to be grouted to freely accommodate a tremie pipe or sounding tube.

5. Drilling fluids used to stabilize the well bore shall be maintained within limits that will allow their complete removal from the water produced from the well, and shall not damage the capacity, efficiency, and quality of the well.

6. Representative samples of formation materials shall be collected during well bore advancement with sufficient frequency to allow for preparation of the driller's log (uniform water well completion report) of the type of rock, sediment, or soil encountered.

C. Casing.

1. The casing shall maintain the well bore by preventing its walls from collapsing, provide a channel for the conveyance of water, and protect the quality of the water withdrawn from the well. The thickness of the casing shall be sufficient to resist the force imposed during installation and which can be anticipated after installation.

2. Class IIIA and IVA wells shall be cased to a depth of at least 100 feet.

3. Class IIIB and IVB wells shall be cased to a depth of at least 50 feet.

4. Except as provided in subdivisions a through e of this subdivision 4, Class IIIC and IVC wells shall be cased to a minimum depth of 20 feet or terminated not less than one foot in bedrock when bedrock is encountered at a depth less than 20 feet.

a. When in collapsing material, the casing shall terminate in the aquifer but in no instance be less than 20 feet.

b. Where an aquifer is encountered at less than 20 feet, Class IVC wells may be cased to within one foot of the water bearing strata. In the instance of Class IV wells the intent of this chapter is to protect groundwater quality, and not to ensure a potable water supply.

c. Alternate casing depths may be accepted for bored wells when the only aquifer lies between 11 and 20 feet provided the casing is placed within one foot of the aquifer and must not be less than 10 feet in depth from the ground surface.

d. Class IIIC driven wells shall be cased to the water bearing strata; however, in no case less than 10 feet. No minimum casing requirements apply to Class IVC driven wells except that in order to protect groundwater they shall be capable of meeting the minimum grouting requirements as described in subdivision F 5 e of this section.

e. Closed-loop ground-source heat pump wells do not have to be cased.

5. When PVC casing is terminated in bedrock, the well casing shall be sealed using a mechanical seal or packer.

6. Extension of casing above ground surface. Private well casings shall be extended at least 12 inches above ground or at least 12 inches above a concrete floor in a well house with a gravity flow drain. The following wells are exempted from this requirement; however, their location shall be permanently marked for easy location in the future:

a. Drilled shallow well suction pump systems that will not operate unless a vacuum is maintained. The casings for these wells are also the suction lines through which water is drawn.

b. Deep well ejector pump systems that utilize a casing adaptor and must maintain a vacuum to operate.

c. Closed-loop ground-source heat pump wells.

d. Heat pump return wells that are completely sealed.

7. The casing shall be centered in the well bore the entire depth of the well in order to provide for even distribution of filter pack and grout in the annular space.

8. Joints shall be compatible with the casing material, specific to the task, and be watertight under normal operating conditions, with watertight joints above the screened interval.

9. Casing straightness and alignment:

a. Casing in all private wells shall be sufficiently straight that it will not interfere with the installation and operation of a pump suitable for the intended purpose of the well.

b. For casing intended to accommodate a line shaft turbine pump, the maximum allowable horizontal deviation of the well from the vertical shall not exceed 2/3 times the smallest inside diameter per 100 feet of that part of the well being tested to the depth of the anticipated pump installation.

D. Screens.

1. The screen shall allow passage of water from the aquifer and provide sufficient tensile, collapse, and compression strength to withstand the physical loading it will be exposed to during installation, completion, development, and operational conditions. When used for the prevention of entry of foreign materials, screens shall be free of rough edges, irregularities, or other defects. A positive watertight seal between the screen and the casing shall be provided when appropriate.

2. Screen length, diameter, and slot size shall be determined based on field examination of representative samples of formation material collected during advancement of the well bore, and may be supplemented by sieve analysis of materials in the water bearing zone or geophysical logging of the well bore.

3. Joints between (i) casing and screen and (ii) screen and screen shall meet the requirements of subdivision C 8 of this section.

4. The bottom of the screen, or of the deepest screen in the case of multiple screens, shall be configured to reduce the possibility of native formation or well construction material heaving up into the screened interval. A closed bottom may not be required for screens installed in some formation materials.

5. The screen shall be centered in the well bore.

E. Filter pack.

1. When a filter pack is required, the filter pack material used shall be determined based on field examination of representative samples of the water bearing formation in the withdrawal interval, and may be supplemented by sieve analysis. The filter pack shall be placed in the annular space by a method that prevents bridging and creates uniform distribution.

2. The filter pack shall extend above the top of the screened interval to a thickness sufficient to compensate for settling that may occur during development and operation of the well.

3. Filter pack material may be used with a screen as a formation stabilizer when water is withdrawn from a poorly consolidated rock subject to disintegration and caving when the well is pumped. Formation stabilizer shall be at least as coarse as the formation native material.

F. Grouting.

1. General. Private wells shall be grouted.

2. Purpose. The annular space between the casing and well bore is one of the principal avenues through which undesirable water and contaminants may gain access to a well. The goal of grouting a well is to preclude the entrance of undesirable water and contaminants. Therefore, the annular space shall be filled with a neat cement grout, a mixture of bentonite and neat cement or bentonite clay grout specifically approved by the manufacturer for use as a grouting material.

3. Based on the well casing material and native geology, grout material shall be selected to minimize potential for spidering, cracking, or separation of grout from the well casing.

4. When an open well bore has been drilled below the depth to which the casing is to be grouted, the lower part of the hole must be backfilled, or a packer must be set in the hole to retain the slurry at the desired depth. Backfilling the hole with gravel and capping with sand is an acceptable practice. Material ordinarily sold as plaster or mortar sand is satisfactory; more than half the sand should be of grain sizes between 0.012 inches and 0.024 inches.

5. Depth.

a. Class IIIA and Class IVA wells shall be grouted to a minimum depth of 20 feet.

b. Class IIIB and Class IVB wells shall be grouted to a minimum depth of 50 feet.

c. Class IIIC and Class IVC wells shall be grouted to a minimum depth of 20 feet when the casing depth is equal to or greater than 20 feet. When the casing depth is less than 20 feet, the casing shall be grouted in accordance with this subsection, from the lower terminus of the casing to the surface.

d. Alternate grouting depths may be accepted for bored wells when the only aquifer suitable for a private well lies between 11 and 20 feet provided the grouting shall terminate at least one foot above the aquifer but must not be less than 10 feet in depth from the ground surface.

e. Driven wells shall be grouted to a minimum depth of five feet by excavating an oversize hole at least four inches in diameter larger than the casing and placing an approved grout mixture into the annular space.

6. Installation. Grout shall be installed by means of one of the following methods.

a. Placement using a grout pump or tremie pipe from the bottom of the annular space upward in one operation until the annular space is filled.

b. Pouring of grout is acceptable for bored wells when the grouting depth does not exceed 20 feet provided there is a minimum of a three-inch annular space and the annular space is free of standing water.

c. Bentonite chips or pellets are acceptable for wells when the grouting depth does not exceed 20 feet.

7. Surface completion of grout. Grout shall be brought to the ground surface and flared to provide a one-foot radius around the casing at least six inches thick. However, whenever pitless adapters are used, the grout shall terminate at the base of the pitless adapter. When an outer casing is necessary to construct a new well, where possible, the outer casing shall be pulled simultaneously with the grouting operation.

G. Additional casing and grouting. When a well is to be constructed within 100 feet of a subsurface sewage disposal system, which has been or is proposed to be installed at a depth greater than five feet below the ground surface, the casing and grouting of the water well shall be increased to maintain at least a 15-foot vertical separation between the trench bottom and the lower terminus of the casing and grouting.

H. Well head.

1. General. No open wells or well heads or unprotected openings into the interior of the well shall be permitted. Prior to the water well systems provider leaving the well construction site, the owner shall have the water well systems provider protect the well bore by installing a cover adequate to prevent accidental contamination.

2. Mechanical well seals. Mechanical well seals (either sanitary well seals or pitless adapters) shall be used on Class III and Class IV wells and shall be watertight and airtight, except as provided in 12VAC5-630-410 I 4.

3. Other. Wells greater than eight inches in diameter shall be provided with a watertight overlapping (shoebox) type cover, constructed of reinforced concrete or steel.

I. Appurtenances passing through casing.

1. General. Openings through well casings shall be provided with a positive water stop.

2. Pitless well adapters. When used, pitless units and pitless adaptors shall be attached to the casing in a manner that will make the connection watertight. If an access port is installed, it shall be watertight.

3. Sanitary well seals. When used, sanitary well seals shall be installed according to the manufacturer's recommendations. A one-piece top plate shall be used on a well that terminates outdoors.

4. Venting. Venting shall be provided in such a manner as to allow for the passage of air, but not water, insects, or foreign materials into the well.

J. Well development.

1. "Well development" means the act of repairing damage to the geologic formation from drilling procedures and increasing the porosity and permeability of the materials surrounding the intake portion of the well. It is accomplished by application of mechanical energy, chemicals, or both to (i) remove drilling fluids and formation damage caused by the well bore drilling and well completion processes; (ii) remove formation fines near the well bore to increase hydraulic conductivity and create a filter medium; (iii) establish optimal hydraulic contact between the well and the geologic formation (aquifer) supplying water; (iv) provide for an acceptable level of sand and turbidity; and (v) provide for an appropriate level of drawdown at the production pumping rate.

2. Private wells shall be developed. Disinfection required by 12VAC5-630-430 and water quality testing required by 12VAC5-630-431 shall not be conducted on a well prior to well development.

K. Well maintenance and repair.

1. Equipment and water or other materials used during hydraulic fracturing of bedrock wells shall comply with 12VAC5-630-400.

2. Private wells shall be disinfected per 12VAC5-630-430 following maintenance, redevelopment, or other activity requiring access to the interior of the casing of a completed well.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 3.7, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024; Volume 41, Issue 14, eff. February 24, 2025.

12VAC5-630-420 Observation, monitoring, and remediation wells

A. Except as provided in subsections B and C of this section, observation, monitoring, and remediation wells are exempted from this chapter. The exemption shall not apply to test and exploration wells constructed for the purpose of evaluating groundwater quality or available quantity related to a proposed beneficial use such as water supply for a subdivision, office park, or proposed commercial or industrial application.

B. Observation, monitoring, and remediation wells shall be constructed in accordance with the requirements for private wells if they are to remain in service after the completion of the groundwater study.

C. Observation, monitoring, and remediation wells shall be permanently abandoned in accordance with 12VAC5-630-450 within 90 days of cessation of use. Unless specifically allowed under terms of a permit issued by DEQ, temporary abandonment of observation, monitoring, and remediation wells shall not occur.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 3.8, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-430 Disinfection

A. Private wells shall be disinfected before placing the well in service.

B. Methodology. Disinfection shall be accomplished by one of the following methods:

1. Maintaining a 100 mg/l solution of chlorine in the well for 24 hours utilizing the dosage rates set forth in 12VAC5-630-470.

2. Applying a quantity of water/chlorine solution to ensure a minimum of 100 mg/L of available chlorine throughout the well and immediate formation materials. Disinfection contact time shall be established on the basis of contact units, which are calculated as mg/L chlorine multiplied by hours of exposure. Contact time shall equate to a minimum of 1,000 contact units (50 mg/L chlorine x 20 hours = 1,000 contact units; 200 mg/L chlorine x 5 hours = 1,000 contact units; etc.).

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 3.9, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-431 Water quality

A. Class IV wells exempt. The water quality requirements contained in this section apply to Class III private wells. Class IV private wells (wells not constructed as a source of water for human consumption) are not subject to water quality requirements.

B. Sample tap. A sample tap shall be provided at or near the water entry point into the system so that samples may be taken directly from the source; this requirement may be met by utilizing the first tap on a line near where the plumbing enters the house (may be a hose bib), provided the tap precedes any water treatment devices.

C. Disinfection. The entire water system, including the well, shall be disinfected prior to use pursuant to 12VAC5-630-430.

D. Sampling. After operating the well to remove any remaining disinfectant, a sample of the water from the well shall be collected for bacteriological examination. The sample may be collected by the owner, water well systems provider, or other person in accordance with procedures established by the department and provided the sample is submitted to a private laboratory accredited by the Department of General Services, Division of Consolidated Laboratory Services, for analysis.

E. Test interpretation. A Class III private well shall be considered satisfactory if the water sample tests negative for coliform organisms as described in subdivision 1 or 2 of this subsection. Sources with positive counts shall be tested as described in subdivision 3 of this subsection to determine if the water supply is amenable to continuous disinfection. Samples that exhibit confluent growth shall be considered inconclusive and another sample shall be collected.

1. When a private well has no unsatisfactory water sample within the previous 12 months, one water sample which tests negative for coliform bacteria shall be considered satisfactory for coliform organisms.

2. When a private well has had one or more positive water samples within the past 12 months for coliform bacteria, at least two consecutive samples must be collected and found negative for coliform organisms before the supply may be considered satisfactory for coliform organisms. The samples must be collected at least 24 hours apart and the well may not be disinfected between samples.

3. When a private well does not test satisfactory for coliform organisms, continuous disinfection may be recommended to the homeowner if the water supply is found to be suitable for continuous disinfection. A minimum of 10 independent samples shall be collected and tested for total coliform using an MPN methodology. To be independent, samples shall be collected no less frequently than one sample per day. The geometric mean of the samples shall be calculated and if the result is less than 100 organisms per 100 ml, the supply shall be considered satisfactory for continuous disinfection.

F. Water treatment. If tests indicate that the water samples test positive for coliform organisms and do not meet the standards described in this section and no other approved source is available, adequate methods of water treatment shall be applied. The treatment device shall be demonstrated to be effective pursuant to subdivision E 3 of this section prior to the issuance of an inspection statement. The district or local health department shall be consulted when treatment is necessary.

G. Conversion of Class IV well to Class III potable well. In order to convert an existing Class IV to a Class III well, the owner shall provide the following information to the local health department.

1. A complete application indicating the intent to convert the well classification.

2. A copy of the existing uniform water well completion report documenting that the well meets Class IIIA, Class IIIB, or Class IIIC construction standards in accordance with this chapter.

3. Confirmation that the well meets separation distance criteria for Class III wells listed on Table 1 of 12VAC5-630-380.

4. A negative bacteria water sample in accordance with subsections D, E, and F of this section.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-440 (Repealed.)

History

• Historical Notes: Derived from VR355-34-100 § 3.10, eff. April 1, 1992; repealed, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-450 Well abandonment

A. The abandonment of a private well governed by this chapter or a private well abandoned as a condition of a permit issued under this chapter shall be administered by the Department of Health in conformance with this section. The owner or owner's agent shall provide advance notification regarding the initiation of well abandonment to the district or local health department to allow department personnel the opportunity to observe well abandonment. The owner or owner's agent shall be under no obligation to delay abandonment activities pending arrival of department personnel.

B. Prohibited materials. The following materials, even if classifiable as clean fill or beneficial use byproducts in other applications, shall not be used as clean fill or grout in any well abandonment procedure.

1. Contaminated media.

2. Non-manufactured gravel, brick, broken concrete, crushed glass, porcelain, or road pavement, except as these materials are present as incidental constituents of undisturbed soil or natural earth materials.

3. Controlled low strength material (flowable fill) or other product incorporating fly ash, other coal combustion byproduct, or other waste.

C. Temporary abandonment. A temporarily abandoned well shall be sealed with a water-tight cap or well head seal. Such a well shall be maintained so that it will not be a source or channel for contamination to groundwater during temporary abandonment.

D. Permanent abandonment. The object of proper permanent abandonment is to prevent contamination from reaching groundwater resources via a component of the well, including casing, annular space, and well cap. Permanently abandoned wells, with the exception of bored wells abandoned per the methods identified in subdivisions 5 a and 5 b (3) of this subsection shall no longer be classified as wells. A permanently abandoned well shall be abandoned in the following manner:

1. Casing material may be salvaged.

2. Before the well is abandoned, it shall be checked from land surface to the entire depth of the well to ascertain freedom from obstructions that may interfere with abandonment operations.

3. The well shall be thoroughly chlorinated using the dosage rates in 12VAC5-630-430 prior to abandonment.

4. Grout used in well abandonment shall conform to 12VAC5-630-400 E.

5. Bored wells, rock or brick-lined, and uncased wells shall be abandoned using one of the following methods:

a. Clean fill method. Bored, rock or brick-lined, and uncased wells abandoned by this method shall remain designated as wells with respect to the siting of onsite sewage treatment system components per the requirements of 12VAC5-610 and 12VAC5-613. The well shall be backfilled with clean fill to the water level. A two-foot-thick bentonite plug shall be placed immediately above the water level. Clean fill shall be placed on top of the bentonite plug and brought up to at least five feet from the ground surface. The top five feet of the well casing, if present, shall be removed from the bore hole. If an open annular space is present around the well casing, the annular space shall be filled with grout to the maximum depth possible, but not less than or equal to 20 feet. A one-foot-thick cement or bentonite grout plug that completely fills the bore void space shall be placed a minimum of five feet from the ground surface. The remaining space shall be filled with clean fill which is mounded a minimum of one foot above the surrounding ground surface. When the well is fewer than 25 feet deep, this procedure shall be followed to the greatest extent possible, including removing at a minimum the top five feet of casing below ground and grouting the open annular space as described in this subdivision. The location of these wells shall be permanently marked for future reference.

b. Grout abandonment method. Bored, rock or brick-lined, and uncased wells abandoned by this method shall no longer be designated as wells, with the exception of subdivision 5 b (3) of this subsection. At a minimum, the top five feet of well casing below ground, if present, shall be removed from the well bore.

(1) When a continuous annular space is present around the well casing, the annular space shall be filled with grout, placed via a tremie pipe, to the maximum depth possible, but not less than 20 feet.

(2) When an annular space is present but not continuous, materials shall be completely removed from the annular space to the maximum depth possible, but not less than 20 feet, and the annular space shall be filled with grout placed via a tremie pipe.

(3) When an annular space is present but not continuous, and cannot be cleared sufficiently for the annular space to be filled with grout to a depth not less than 20 feet, then accessible annular space will be filled with grout placed via a tremie pipe. Wells in which the annular space cannot be filled with grout to depth of at least 20 feet shall be treated as a well with respect to the siting of onsite sewage treatment components per the requirements of 12VAC5-610 and 12VAC5-613.

(4) If existing well documentation (uniform water well completion report) indicates that the annular space is filled with grout to a minimum depth of 20 feet, the condition of the grout shall be confirmed by visual observation of the top of the grout following the removal of the top five feet of well casing below ground. If the grout appears intact, no further confirmation of grout condition shall be required and abandonment shall proceed. If the grout condition appears compromised based on visual examination, then the requirements of subdivision 5 b (2) or 5 b (3) of this subsection shall apply.

(5) Once the annular space is addressed, the well shall be pumped dry and completely filled with grout poured from the surface. If the well is not pumped dry, grout shall be placed by introduction through a tremie pipe. The placement of grout in the well bore shall completely fill the bore void space to within a minimum of five feet from the ground surface. The well shall be capped with clean fill which is mounded a minimum of one foot above the surrounding ground surface. When the well is fewer than 25 feet deep, this procedure shall be followed to the greatest extent possible, including removing at a minimum the top five feet of casing below ground and cleaning or grouting the open annular space as described in this subdivision.

6. Drilled wells, including observation, monitoring, and remediation wells constructed in collapsing material shall be completely filled with grout placed via a tremie pipe. The well shall be capped with clean fill mounded to a minimum of one foot above the surrounding ground surface and graded to provide positive drainage away from the well.

7. Drilled wells, including observation, monitoring, and remediation wells, constructed in consolidated rock formations or which penetrate zones of consolidated rock shall be completely filled with grout placed via a tremie pipe. At the discretion of the water well service provider, the well may be filled with sand or gravel opposite the zones of consolidated rock. The top of the sand or gravel fill shall be at least five feet below the top of the consolidated rock and at least 20 feet below the land surface. The remainder of the well shall be filled with grout placed via a tremie pipe. The well shall be capped with clean fill mounded to a minimum of one foot above the surrounding ground surface and graded to provide positive drainage away from the well.

8. Other abandonment procedures may be approved by the division on a case by case basis.

9. When bored wells are advanced and a water source is not found, and the casing has not been placed in the bore hole, the well bore shall be abandoned by backfilling with the cuttings or clean fill or both to at least five feet below the ground surface. A two-feet-thick plug of grout shall be placed at a minimum of five feet from the ground surface. The remainder of the bore hole shall be filled with the cuttings or clean fill or both.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-100 § 3.11, eff. April 1, 1992; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-460 Water system yields for residential use wells

A. Drinking water systems that utilize one or more Class III wells shall be capable of supplying water in adequate quantity for the intended usage. Systems with a capacity under three gallons per minute shall have ability to produce and store 150 gallons per bedroom per day and be capable of delivering a sustained flow of five gallons per minute per connection for 10 minutes for ordinary residential use. Systems with a capacity of three gallons per minute or more do not require additional storage.

B. The certified water well systems provider shall certify the storage capacity and the yield of the well on the Uniform Water Well Completion Report.

History

• Statutory Authority: §§ 32.1-12 and 32.1-176.4 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 22, eff. August 16, 2012; amended, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-470 (Repealed.)

History

• Historical Notes: Derived from VR355-34-100, Appendix II; eff. April 1, 1992; repealed, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

12VAC5-630-480 (Repealed.)

History

• Historical Notes: Derived from VR355-34-100, Appendix III; effective April 1, 1992; repealed, Virginia Register Volume 41, Issue 4, eff. November 6, 2024.

Chapter 635 Rainwater Harvesting System Regulations

Part I General Framework

12VAC5-635-10 Definitions

The following words, terms, and abbreviations, when used in this chapter, shall have the following meanings unless the context clearly indicates otherwise:

"Agent" means a legally authorized representative of the owner.

"ANSI" means the American National Standards Institute.

"ASSE" means the American Society of Sanitary Engineering.

"Backflow" means (i) the flow of water, other liquids, mixtures, or substances into the distribution system of a pure water system from one or more sources other than its intended source or (ii) the reversal of the normal direction of flow.

"Cistern" means a water storage tank connected to a plumbing system or irrigation system.

"Commissioner" means the State Health Commissioner or the commissioner's designee.

"Contaminant" means an objectionable or hazardous physical, chemical, biological, or radiological substance or matter in water.

"Conveyance system" or "roof drainage system" means the portion of a rainwater harvesting system that directs collected rainwater to the point of untreated rainwater storage, including gutters, downspouts, roof drains, and connectors.

"Cross-connection" means any physical connection or arrangement between two otherwise separate piping systems whereby there exists the possibility for flow from one system to the other, with the direction of flow depending on the pressure differential between the two systems.

"Debris excluder" means a screen or other device installed in the gutter or downspout system to prevent the accumulation of leaves, needles, or other debris in the rainwater harvesting system.

"Department" means the Virginia Department of Health.

"Designer" means a person who is employed or contracted by an owner to design a rainwater harvesting system and holds certification as a designer pursuant to 12VAC5-635-270 C. Owners may be certified to become designers.

"Disinfection" means a process that inactivates or destroys pathogenic organisms in water by use of a disinfectant. A disinfectant is any chemical and physical agent, including chlorine, chlorine dioxide, chloramines, ozone, and ultraviolet light, added to water in any part of the treatment or distribution process for the purpose of killing or inactivating pathogenic organisms.

"Distribution system" means piping and other components carrying water from a rainwater harvesting system to the point of use.

"End use" means the use of water from a rainwater harvesting system.

"End use tier" means a categorization applied to a rainwater harvesting system based on potable or nonpotable water quality; end use; and potential for human contact, including ingestion, inhalation, and skin contact.

"Filtration" means a process for removing particulate matter from water by passage through porous media.

"First flush" means a method for the removal of sediment and debris from the collection surface by diverting initial rainfall from entry into the storage unit.

"Harvested rainwater" means water from precipitation, including snowmelt, that falls on an elevated roof not subject to pedestrian access and is directed through gutters and downspouts to a storage tank prior to contact with the ground.

"Human consumption" means drinking, food preparation, dishwashing, bathing, showering, hand washing, teeth brushing, and maintaining oral hygiene.

"Installer" means the service provider responsible for installation of a rainwater harvesting system in accordance with the construction permit.

"Local health department" means the department established in each city and county in accordance with § 32.1-30 of the Code of Virginia.

"Log reduction" means the removal of organisms expressed on a logarithmic scale. For example, a 99.9% is a 3-log removal; whereas a 99.99% is a 4-log removal.

"Log reduction target" means a level of log removal assigned to an end use tier.

"Maintenance" means performing adjustments to equipment and controls and in-kind replacement of normal wear and tear parts such as light bulbs, fuses, filters, pumps, motors, conveyance subsystem components, or other like components. Maintenance includes pumping the tanks or cleaning the system components, including tanks, on a periodic basis. Maintenance shall not include replacement of water storage units or work requiring a construction permit and an installer.

"Nonpotable water" means water not classified as pure water.

"NSF" means NSF International, formerly known as the National Sanitation Foundation. NSF collaborates with ANSI and Canadian authorities on drinking water standards development. "NSF/ANSI/CAN" is the abbreviation for that collaboration.

"Operation and maintenance manual" means the set of materials and documentation maintained by an owner containing the instructions and information required by 12VAC5-635-350.

"Operator" means a person employed or contracted by an owner to operate and maintain a rainwater harvesting system and holding certification as a designer, installer, or inspector as described in 12VAC5-635-270 C. Owners may be certified to become operators.

"Owner" means any person, individual, corporation, partnership, association, cooperative, limited liability company, trust, joint venture, government, political subdivision, or any other legal or commercial entity and any successor, representative, agent, or instrumentality thereof, who owns, leases, or proposes to own or lease a rainwater harvesting system.

"Point of use" means a point in a domestic water system nearest to a water-consuming plumbing fixture where water is used.

"Potable water" or "pure water" means water fit for human consumption that (i) is sanitary and normally free of minerals, organic substances, and toxic agents in excess of reasonable amounts; (ii) is adequate in quantity and quality for the minimum health requirements of the persons served; and (iii) conforms to potable water standards defined in the Virginia Uniform Statewide Building Code.

"Precipitation" means water that has precipitated from the atmosphere, including rain, snow, sleet, hail, mist, fog, and dew.

"Rainwater harvesting system" means a water system for collecting, storing, potentially treating, and distributing rainwater for an end use.

"Screen" means a filtration device constructed of corrosion-resistant wire or other approved mesh, having openings in determined sizes.

"Secondary water supply" means an alternate source of water that serves a rainwater harvesting system for the purpose of continuity of water supply.

"Service connection" means the point of delivery of water from a rainwater harvesting system to the distribution system of a user. In the case of a building having multiple independent tenants, each independent tenant is considered a service connection for the purpose of this chapter, regardless of distribution system configuration. In general, a service connection is a single residential unit or commercial space.

"Stormwater" means precipitation that is discharged across the land surface or through conveyances to one or more waterways and that may include stormwater runoff, snow melt runoff, and surface runoff and drainage.

"Treatment" means the use of physical, biological, or chemical means to make water suitable for the intended use.

"Treatment system" or "water treatment system" means the equipment and components used to achieve treatment of rainwater, most commonly filtration and disinfection.

"USBC" means the Virginia Uniform Statewide Building Code (§ 36-97 et seq. of the Code of Virginia).

"Variance" means a conditional waiver of a specific regulation that is granted to a specific owner relating to a specific situation or facility and may be for a specified time period.

"Water storage unit" means a cistern or tank used as the central storage component of the rainwater harvesting system prior to treatment.

"Waterworks" means a system that serves piped water for human consumption to at least 15 service connections or 25 or more individuals for at least 60 days out of the year.

"Written operational record" means the official record of the maintenance and operations of a rainwater harvesting system that contains the items required in 12VAC5-635-330 C.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

12VAC5-635-20 Applicability of regulation

A. This chapter does not apply to rainwater harvesting systems installed, altered, or rehabilitated prior to November 20, 2024, unless the rainwater harvesting system is altered or rehabilitated after November 20, 2024.

B. The following are excluded from the requirements of this chapter.

1. Rain barrels (individual containers used to collect and temporarily store rainwater solely for Tier 1 end use);

2. Rainwater harvesting systems that serve as a source for a waterworks as regulated by the Waterworks Regulations (12VAC5-590);

3. Rainwater harvesting systems for Tier 1, 2, or 3 end use conducted for an agricultural operation as defined by § 3.2-300 of the Code of Virginia; and

4. Stormwater reclamation and reuse systems authorized by the Department of Environmental Quality in accordance with regulations adopted pursuant to § 62.1-44.15:28 of the Code of Virginia, including stormwater reclamation and reuse systems that may reclaim combined stormwater and harvested rainwater.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024; amended, Virginia Register Volume 42, Issue 2, eff. October 8, 2025.

12VAC5-635-30 Relationship to Virginia Sewage Handling and Disposal Regulations

This chapter supersedes 12VAC5-610-1170 of the Virginia Sewage Handling and Disposal Regulations, which addresses cisterns, in cases where a cistern is used solely as a component of a rainwater harvesting system subject to the requirements of this chapter.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

12VAC5-635-40 Relationship to the State Water Control Board

This chapter addresses the standards for the collection and use of that portion of stormwater not regulated in accordance with 9VAC25-31, 9VAC25-32, 9VAC25-151, 9VAC25-840, 9VAC25-870, 9VAC25-880, and 9VAC25-890.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

12VAC5-635-50 Relationship to the Uniform Statewide Building Code

A. This chapter is independent of and in addition to the requirements of the USBC in accordance with § 36-98 of the Code of Virginia.

B. All persons required to obtain a rainwater harvesting system installation permit for a system for Tier 4 end use shall furnish a copy of the installation permit to the local building official when making application for a building permit.

C. The applicant for a rainwater harvesting system for Tier 4 end use shall furnish the local building official with a copy of the operating permit demonstrating the potable water supply has been inspected, sampled, and approved by the local health department.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

12VAC5-635-60 Right of entry and inspections

In accordance with § 32.1-25 of the Code of Virginia, the commissioner or a designee shall have the right to enter any property to ensure compliance with this chapter.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

Part II Procedural Requirements

12VAC5-635-70 End use tiers for rainwater harvesting systems

The end use tier categorization of harvested rainwater is based on water quality, intended end uses, and associated potential for human contact through ingestion, inhalation, and skin contact. The examples of common-use applications are not intended to represent all possible applications. Where end use applications are not listed, or are subject to interpretation, the application shall be categorized based on the highest numbered applicable end use tier description. The end use tiers are as follows:

1. Tier 1. Low exposure end use: Nonpotable water use where humans will rarely come into contact with the treated rainwater due to the nature of the installation that limits direct or indirect contact under normal operation. Examples include trap primers, restricted access spray irrigation, surface and subsurface irrigation, and ice rinks. In this context, restricted access spray irrigation means spray irrigation in fenced or remote locations where human visitation is controlled or prevented.

2. Tier 2. Medium exposure end use: Nonpotable water use where human contact with treated rainwater is indirect or limited. Examples include toilet and urinal flushing, clothes washing, heating, ventilation, and air conditioning systems, evaporative cooling, and rooftop thermal cooling.

3. Tier 3. High exposure end use: Nonpotable water use where human contact with treated rainwater is direct. Examples include hose bibs, pressure washing, firefighting or protection and fire suppression, decorative fountains, vehicle washing, and nonrestricted spray irrigation.

4. Tier 4. Potable water end use: Intended for human consumption.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

12VAC5-635-80 Reserved

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Reserved, Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

12VAC5-635-90 Permits for rainwater harvesting systems; general

A. No person may install, alter, or rehabilitate or allow the installation, alteration, or rehabilitation of a rainwater harvesting system intended for Tier 4 end use without a written construction permit from the commissioner.

B. Unless suspended or revoked pursuant to 12VAC5-635-190, a construction permit for a Tier 4 rainwater harvesting system shall be valid for a period of 36 months from the date of issuance.

C. An owner may install and operate a rainwater harvesting system intended for Tier 1, 2, or 3 end use without a permit. The owner of a Tier 1, 2, or 3 end use rainwater harvesting system shall file a registration form with the department within 30 calendar days of the following:

1. Installing a rainwater harvesting system; or

2. The permanent discontinuation of use of a rainwater harvesting system such that harvested rainwater is not used for any purpose.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

12VAC5-635-100 Application procedures for a construction permit for a rainwater harvesting system for Tier 4 end use

A. The owner of a proposed rainwater harvesting system shall sign and submit a written permit application to the local health department for the locality where the proposed rainwater harvesting system would be located that contains the following information:

1. The owner's name, address, and telephone number;

2. The applicant's name, address, and telephone number (if different from the owner's);

3. A statement signed by the owner or agent granting the department access to the site to conduct a sanitary survey if underground water storage is proposed and to inspect the rainwater harvesting system after it is installed; and

4. Plans for the proposed rainwater harvesting system, including specifications, design criteria, manufacturer's literature, a proposed schematic, a general layout of any underground water storage, additional written plans for multiple service connection systems, the operation and maintenance manual required pursuant to 12VAC5-635-350, and other supporting information or data the department may request.

C. If underground storage of harvested rainwater is proposed, a general layout shall be provided that includes topography, elevations, contour lines, and existing or proposed streets and identifies the following conditions located within 100 feet horizontally of the proposed water storage units: potential sources of contamination, bodies of water, ditches, buildings, springs, aboveground cisterns, and wells.

D. If the proposed rainwater harvesting system will provide Tier 4 end use water to multiple service connections, the applicant shall include a plan as follows:

1. The plan shall have a cover sheet with suitable title showing the name of the owner, date the plan was prepared, and the name of the licensed individual by or under whom the plans were prepared. The cover sheet and each subsequent page shall bear the same general title and each shall be numbered. Appropriate subtitles shall be included on individual sheets.

2. The plan shall be prepared to a scale that will permit necessary information to be shown clearly and legibly.

3. The plan shall consist of plan views, elevations, sections, and supplementary views that together with the specifications and general layouts provide the working information for the contract and construction of the proposed rainwater harvesting system, including dimensions and relative elevations of structures, the location and outline form of equipment, the location and size of piping, water levels, ground elevations, and erosion control abatement facilities.

4. The plan shall include the technical specifications for the construction of the rainwater harvesting system and all appurtenances. The specifications shall include all construction information not shown on the drawings, which is necessary to inform the installer in detail of the design requirements as to the quality of material workmanship and fabrication of the project; the type, size, strength, operating characteristics, and rating of equipment and materials used in the construction and operation of the rainwater harvesting system; allowable infiltration, machinery, valves, piping, and jointing of pipe, electrical apparatus, wiring, and meters; operating tools and construction materials; miscellaneous appurtenances; chemicals when used; and instructions for testing materials and equipment as necessary to meet design standards and operating test for the complete works and component units.

E. An application shall be deemed complete upon receipt by the local health department of a signed and dated application ].

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

12VAC5-635-110 Issuance of a construction permit

The commissioner shall issue a construction permit to the owner no later than 60 calendar days after receipt of a complete application if:

1. The proposed rainwater harvesting system is compliant with this chapter and other applicable laws, ordinances, and regulations; and

2. The owner has obtained the easements pursuant to this chapter and provided the documentation of the easement with the application.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

12VAC5-635-120 Denial of a construction permit

If the commissioner determines that the proposed rainwater harvesting system does not comply with this chapter or that the installation and operation of the system would create an actual or potential health hazard or nuisance, the commissioner shall deny the construction permit application and notify the owner in writing no later than 60 calendar days after receipt of the complete application with the basis for the denial. The notification shall also state that the owner has the right to appeal the denial in accordance with 12VAC5-635-190.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

12VAC5-635-130 Revision of approved plans

A. The rainwater harvesting system designer with the consent of the owner may make certain design changes to a proposed rainwater harvesting system for which a valid construction permit has been issued without prior approval from the department if:

1. The design change does not change the design flow, the proposed filtration means and standard, the proposed disinfection means and standard, or the log reduction targets;

2. The changed design for the rainwater harvesting system complies with applicable statutes, codes, and regulations;

3. The designer provides the department with complete documentation, including a list of changes and revised specifications, calculations, and drawings as part of a revised design package; and

4. The designer and owner ensure that design changes are communicated to the installer of the rainwater harvesting system.

B. The commissioner may suspend or revoke a construction permit if a design change made to the proposed rainwater harvesting system does not comply with this chapter. If the commissioner revokes the construction permit, the owner must submit a new application before continuing with the installation of the rainwater harvesting system.

C. The commissioner shall review changes made to the rainwater harvesting system before issuing an operation permit pursuant to 12VAC5-635-170.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

12VAC5-635-140 Installation inspection and correction

A. Upon completion of the installation, alteration, or rehabilitation of a Tier 4 rainwater harvesting system ]:

1. The owner or agent shall submit to the local health department a statement signed by the installer certifying that the rainwater harvesting system was installed, altered, or rehabilitated in accordance with the construction permit and that the rainwater harvesting system complies with applicable state and local regulations, ordinances, and laws;

2. The designer shall thoroughly inspect the system installation to determine whether the installation was completed in accordance with the approved evaluation and design, including any revisions made pursuant to 12VAC5-635-130; and

3. The designer shall submit to the local health department a signed inspection report stating that the installation was completed in accordance with the approved evaluation and design revised only in accordance with the provisions of 12VAC5-635-130.

B. If the designer observes deficiencies during the inspection, the designer shall note the deficiencies in the inspection report and include a plan of correction that includes the specific corrective actions that will be taken to bring the rainwater harvesting system into compliance with this chapter, the date on which the corrective actions will be completed, and the date the designer will perform a follow-up inspection of the corrected rainwater harvesting system.

C. After the follow-up inspection, the designer shall submit a signed inspection report to the local health department affirming whether the corrective actions have been taken and whether the rainwater harvesting system is installed in compliance with the approved evaluation and design.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

12VAC5-635-150 Requirement for an easement

A. If a rainwater harvesting system or a portion of the rainwater harvesting system is proposed to be installed on property other than the owner's, the owner must obtain an easement in perpetuity of sufficient area to permit access to install, maintain, and operate the rainwater harvesting system components from the appropriate property owner and record the easement with the clerk of the circuit court before issuance of a construction permit.

B. The owner shall submit legal documentation of recordation of the easement or a signed statement that the easement will be recorded within 45 calendar days to the appropriate local health department with the application for a construction permit.

C. If the owner does not obtain, properly record, and submit documentation of the easement, the owner may not install or operate the rainwater harvesting system on the property for which the easement was denied.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

12VAC5-635-160 Land records

A. Before the commissioner may issue an operation permit for a Tier 4 rainwater harvesting system , the owner must:

1. Record an instrument describing applicable annual water quality testing and maintenance requirements for each component of the rainwater harvesting system in the land records of the circuit court having jurisdiction over the site of the rainwater harvesting system; and

2. Submit to the local health department legal documentation indicating that the instrument has been duly recorded in the land records.

B. The instrument recorded pursuant to this section shall be transferred with the title to the property upon the sale or other transfer of the property in which the rainwater harvesting system is located.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

12VAC5-635-170 Issuance of operation permit

A. No Tier 4 rainwater harvesting system may be operated, except for the purposes of testing the system, until the commissioner has issued an operation permit to the owner.

B. If the owner has complied with the requirements of 12VAC5-635-140, 12VAC5-635-160, and this section, the commissioner shall issue to the owner a Tier 4 end use permit to operate the rainwater harvesting system ].

C. The issuance of an operation permit does not denote or imply a warranty or guarantee by the department that the rainwater harvesting system will function for any specified period of time. The owner shall maintain, repair, or replace a rainwater harvesting system that ceases to operate as defined in the operation permit and operation and maintenance manual.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

12VAC5-635-180 Variances

A. In accordance with § 32.1-12 of the Code of Virginia and this chapter, the commissioner may grant a variance to a requirement of this chapter.

B. The commissioner may grant a variance if an investigation reveals that, in the opinion of the commissioner, a hardship imposed by a requirement within this chapter, including an economic hardship, outweighs the benefits that may be received by the public and that granting the variance does not subject the public to unreasonable health risks or environmental pollution.

C. The owner shall submit a signed, written application for a variance to the appropriate local health department. The application shall include:

1. A citation to the section to which a variance is requested;

2. The nature and duration of the variance requested;

3. Any relevant analytical results, including results of relevant tests conducted pursuant to the requirements of this chapter;

4. The specific hardship created by the requirement to which a variance is requested;

5. Statements or evidence that establishes that the public health or welfare and the environment would not be adversely affected if the variance were granted;

6. Suggested conditions that might be imposed on the granting of a variance that would limit the detrimental impact on the public health and welfare;

7. Other information believed pertinent by the applicant; and

8. Other information the local health department or commissioner may require.

D. In the evaluation of a variance application, the commissioner shall consider:

1. The effect that the variance would have on the construction, location, or operation of the rainwater harvesting system;

2. The cost and other economic considerations imposed by the requirement to which the variance is sought;

3. The effect that such a variance would have on protection of the public health or welfare and the environment;

4. Relevant analytical results, including results of relevant tests conducted pursuant to the requirements of this chapter; and

5. Information or materials on the application for a variance submitted per this section.

E. The commissioner shall not recognize as a hardship the cost to correct an error created by a design change initiated by the owner or designer for which approval by the department was required pursuant to 12VAC5-635-130 but was not obtained.

F. The commissioner may deny any applicant for a variance by sending a written denial notice to the applicant that states the reasons for the rejection. If the commissioner denies the variance, the owner shall be provided with an opportunity for an informal fact-finding proceeding as provided in § 2.2-4019 of the Code of Virginia.

G. If the commissioner proposes to grant a variance request submitted pursuant to this section, the commissioner shall notify the owner in writing of the decision within 60 calendar days of receipt of the variance request. The notice shall identify the requirement to which the variance is granted, the rainwater harvesting system covered, the period of time for which the variance will be effective, and the conditions imposed pursuant to issuing the variance.

H. Unless otherwise stated in the terms or conditions of the variance, the variance shall be transferred with the permit if the owner of a rainwater harvesting system sells or otherwise transfers ownership of the rainwater harvesting system to a new owner.

I. If a permit is revoked or suspended, variances attached to it shall also be revoked or suspended.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

12VAC5-635-190 Enforcements, notices, informal conferences, appeals

A. Rainwater harvesting systems shall be installed, operated, and maintained in compliance with the requirements as set forth in this chapter. The commissioner may enforce this chapter through the means lawfully available pursuant to Title 32.1 of the Code of Virginia, and nothing in this chapter shall be construed as preventing the commissioner from making efforts to obtain compliance through warning, conference, or other appropriate enforcement means.

B. The commissioner may deny a permit application or suspend or revoke a permit issued pursuant to this chapter if:

1. The permit holder fails to comply with this chapter, applicable law, or a condition imposed on the permit; or

2. The commissioner is made aware that:

a. The facts upon which the approval of a construction permit was based were knowingly and willfully misrepresented; or

b. The installation or operation of the proposed rainwater harvesting system could create a substantial or imminent public health or environmental hazard.

C. The commissioner shall notify the owner of a notice of suspension in writing via certified mail or via hand delivery. Immediately upon receipt of a notice of suspension, the owner shall cease operation of the rainwater harvesting system.

D. The owner of a permitted rainwater harvesting system shall ensure the continuity of water supply to persons who use the rainwater harvesting system's treated water for human consumption. If the owner demonstrates to the satisfaction of the commissioner that ceasing the operation of a permitted rainwater harvesting system would endanger the health of the persons who use the rainwater harvesting system's finished water, the commissioner may issue a variance to the requirement to cease operation pursuant to 12VAC5-635-180.

E. Within 10 working days of receipt of a notice of denial of an application or suspension of a permit, the owner may request an informal conference in accordance with § 2.2-4019 of the Code of Virginia. The owner must file the request for an informal conference in writing with the local health department within the locality that the rainwater harvesting system is located. If a request for an informal conference is not filed within 10 working days, the denial or suspension is sustained.

F. Within 10 working days of receipt of a notice of denial, suspension, or intent to revoke, the owner shall submit to the appropriate local health department a plan of correction that includes:

1. The specific corrective actions that will be taken to address the reasons for denial, suspension, or revocation and bring the rainwater harvesting system into compliance with this chapter and other applicable requirements;

2. The date on which the corrective actions are expected to be completed; and

3. If the rainwater harvesting system is in operation, an application for a construction permit for alteration, repair, or rehabilitation of the rainwater harvesting system pursuant to 12VAC5-635-100.

G. Within 10 working days of the receipt of the plan of correction, the department shall:

1. Notify the owner in writing if any item is determined to be unacceptable; and

2. Act on an application for a construction permit to perform repairs pursuant to this section.

H. If the owner does not submit a plan of correction or request an informal conference within 10 working days, the department shall notify the owner in writing that the application for a permit is denied or that the permit is deemed suspended or revoked.

I. The department shall arrange for an informal conference to be held within seven working days of receipt of a request for an informal conference pursuant to this section.

J. The commissioner may end a suspension and reinstate a permit at any time if the conditions under which the permit was suspended have changed or no longer exist.

K. The owner must reapply for a permit in order to continue installing or operating a rainwater harvesting system for which the permit has been revoked.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

Part III Design and Installation

12VAC5-635-200 Cross-connection abatement

No rainwater harvesting system may be installed, operated, or allowed on any premises where cross-connection to a waterworks or a private well exists, unless the cross-connections are abated or controlled by means including cross-connection control and backflow prevention in accordance with the USBC. Where cross-connection to a waterworks exists, the cross-connection shall be abated or controlled to the satisfaction of the waterworks.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

12VAC5-635-210 Backflow prevention

A. A rainwater harvesting system shall be designed, installed, and maintained to prevent contamination of secondary water supplies by backflow. Backflow prevention shall be achieved by one or more of the following:

1. Backflow elimination methods, including air gap separation or physical disconnection;

2. Backflow prevention assemblies, including the reduced pressure principle, double check valve, and pressure vacuum breaker assemblies; or

3. If backflow prevention is not generally required to withstand continuous pressure over 12 hours or to control high hazards, a backflow prevention device, including atmospheric type vacuum breakers and dual check valve devices.

B. Backflow prevention assemblies and backflow prevention devices shall be suitable to the application and shall conform to the USBC.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

12VAC5-635-220 Water storage unit location

A. An underground water storage unit for a rainwater harvesting system shall be sited with appropriate consideration given to distance from potential contamination sources, vulnerability to known or suspected natural risks (e.g., flooding and sink holes), potential for interference with utilities, and safety.

B. If the rainwater harvesting system will include an underground installation of a water storage unit, the designer shall conduct a sanitary survey, including investigation of obvious sources of toxic or dangerous substances within 200 feet of the water storage unit. Sources of contamination may include items listed in Table 1. The minimum separation distance between an underground water storage unit and sources of contamination shall comply with the minimum distances shown in Table 1.

| TABLE 1 Separation distance between underground water storage unit and potential source of contamination | | | --- | --- | | Potential Source of Contamination | Separation Distance (feet) | | Active or permitted septic tank, holding tank, pump tank, aerobic unit, house sewer line, sewer line, sewer main, sewerage system | 50 | | Active or permitted drainfield, including reserve drainfield | 50 | | Permanently abandoned onsite sewage disposal system | 35 | | Petroleum storage tank, drum, tote, or other container (underground) | 100 | | Petroleum storage tank, drum, tote, or other container (aboveground) | 50 |

C. An aboveground water storage unit shall be installed on a sturdy and level foundation or platform with adequate drainage capable of bearing the weight of the unit at capacity. If multiple storage units are connected, compliant fittings must be used and installed in a manner that provides adequate flexibility to allow for unit settlement or movement.

D. A water storage unit and associated pipes and pipe fittings and appurtenances to be installed in locations subject to direct sunlight shall be constructed of materials stable under ultraviolet light exposure anticipated over the life of the system.

E. A water storage unit shall be supported and restrained to prevent lateral movement. Support and restraint devices may not be placed in a manner that will obstruct access for cleaning and maintenance.

F. A water storage unit subject to a shallow water table shall be ballasted or otherwise secured to prevent floatation or lateral movement. The unit shall be designed to withstand structural stresses of hydrostatic pressure and buoyancy. If partially buried, design shall include provision to withstand the weight of backfill.

G. A water storage unit subject to vehicular traffic shall be installed in accordance with manufacturer's installation instructions and the USBC.

H. A water storage unit shall have at least one access opening to allow inspection and cleaning of the unit interior. The access opening shall be located to facilitate pumping and servicing of inlets and outlets. The access opening shall be locked or otherwise secured to prevent unauthorized access and shall be located at a finished grade such that surface water ponding does not occur under annual precipitation extreme conditions.

I. A water storage unit shall be fitted with an overflow discharge system with the following requirements:

1. Overflow is not less than the capacity of the inlets;

2. Unit overflow pipes are protected from insects and vermin;

3. Piping associated with unit overflow discharges water away from the unit and in accordance with the USBC;

4. Discharge of unit overflow is directed to prevent hazardous conditions;

5. No shutoff valves are incorporated into discharge piping;

6. Cleanouts are provided on overflow piping in accordance with the USBC;

7. If connected to storm drainage systems, the storm drainage systems have a means to prevent backflow; and

8. Overflows are not directed to onsite sewage systems or sanitary sewers.

J. A water storage unit shall be fitted with a vent pipe having a minimum 38.1 mm diameter protected with 1.5 mm mesh to prevent the entry of vermin and particulates.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

12VAC5-635-230 Materials and equipment

A. Materials and equipment used in rainwater harvesting systems shall be labeled to demonstrate compliance with applicable NSF 61 and NSF P151 standards, as appropriate.

B. Collection surfaces shall comply with the following requirements:

1. Collection roofing are composed of non-toxic materials;

2. Paint used on surfaces used for collection of rainwater for potable purposes is labeled to be certified to NSF/ANSI/CAN Standard 61-2020 or P151 and applied per the manufacturer's installation instructions;

3. Lead-based, chromium-based, or zinc-based paints are not used;

4. Galvanized metal is not used;

5. Flat roof products are labeled as meeting NSF Protocol P151;

6. Equipment and appliances mounted on collection surfaces have a means of preventing the introduction of contaminants into the rainwater harvesting system;

7. Equipment and appliances containing toxic fluids or other potentially harmful substances are not installed on collection surfaces or in locations where a release of contained substances will flow by gravity to collection surfaces; and

8. Materials used for collection surfaces conform to end use tier criteria pursuant to Table 2.

| TABLE 2. Collection Surface Materials | | | --- | --- | | Roofing Material (including flashing) | Acceptable for End Use Tier | | Asbestos cement | Not acceptable for any end use | | Asphalt | 1, 2, 3, 4 | | Asphalt felt and bituminous and tar membranes | 1, 2, 3 | | Ceramic | 1, 2, 3, 4 | | Clay | 1, 2, 3, 4 | | Concrete | 1, 2, 3, 4 | | Copper | 1, 2, 3 | | Fiberglass | 1, 2, 3, 4 | | Glass | 1, 2, 3, 4 | | Polyethylene membrane | 1, 2, 3, 4 | | Polymer and acrylic | 1, 2, 3 | | Rubber/Butyl/EPDM membrane | 1, 2, 3 | | Steel, coated | 1, 2, 3, 4 | | Steel, stainless | 1, 2, 3, 4 | | Tin | 1, 2, 3, 4 | | Wood, untreated | 1, 2, 3 | | Wood, treated | 1, 2, 3 | | PVC | 1, 2, 3, 4 | | TPO | 1, 2, 3 | | Public pedestrian accessible roofs | 1, 2, 3 | | Vegetated roofs | 1, 2, 3 | | Pedestrian and parking surfaces (rooftop) | 1, 2, 3 |

C. The conveyance system shall be protected to prevent the entrance of vermin. Inlets, debris excluders, filters, first-flush diverters, cleanouts, and conveyance system components requiring service shall be accessible. To convey captured rainwater, rainwater harvesting systems shall use drainage piping suitable for use with plumbing drainage or pressure systems. Conveyance system materials shall be labeled to demonstrate compliance with NSF/ANSI/CAN Standard 61-2020.

D. A cistern or water storage unit, liners, coatings, pipes, pipe fittings, and appurtenances shall be labeled to demonstrate compliance with the applicable requirements of NSF 61/ANSI/CAN Standard 61-2020 and NSF 372. The water storage unit shall be manufactured from previously unused materials, and no cistern or storage unit previously used to store anything other than water may be incorporated into a rainwater harvesting system. The water storage unit may be installed either above or below grade and provided a means for emptying and cleaning. If gravity drainage is not possible, a provision for pumping water from the unit shall be provided.

E. Water contained in an aboveground water storage unit shall be protected from direct sunlight through the use of opaque, ultraviolet-resistant materials or a sun barrier.

F. An underground water storage unit shall be installed in compliance with U.S. Occupational Safety and Health Administration Standard 1926 Subpart P and shall be provided with manhole risers a minimum of six inches above surrounding grade.

G. Pump and pump components shall be capable of delivering a minimum of 15 pounds per square inch in gauge residual pressure at the highest and most remote outlet served. Maximum pressure should not exceed 80 pounds per square inch in gauge.

H. Water piping, fittings, and related system components shall be appropriate for use in accordance with the USBC. Where plastic piping is exposed to sunlight, it shall be protected by a factory applied protective coating or painted with compatible latex paint.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

12VAC5-635-240 Design and installation

A. The rainwater harvesting system shall be designed, installed, operated, and maintained to prevent contamination of water supplies and distribution piping.

B. Rainwater harvesting system components shall be protected from external contamination and entry by insects and vermin.

C. The rainwater harvesting system shall be sited and designed to produce and store water under local site conditions that include:

1. Excessive heat;

2. Freezing;

3. Flooding; and

4. Sunlight exposure.

D. The owner shall control access to rainwater harvesting system components to minimize unauthorized access.

E. Gutters, downspouts, and conveyance systems leading to the water storage unit shall be fitted with a screen or debris excluder to prevent the accumulation of leaves, needles, or other debris into the water storage tank or cistern.

F. Vegetation above roofs and gutters shall be removed to reduce organic matter falling on and decomposing in rainwater collection surfaces and conveyances, and to reduce or remove locations for animals to introduce contaminants.

G. Rainwater shall pass through a prefiltration system prior to entering the water storage unit or cistern. Appropriate prefiltration devices include a gutter screen, inline filters, and vortex filters to reduce organic matter, debris, and particulates from entering and accumulating in the bottom of the unit or cistern. Prefiltration devices without a self-cleaning design shall incorporate a corrosion-resistant debris screen having openings no larger than 0.15 cm.

H. A first flush device shall be used to remove accumulated debris from the collection surface before rainwater is introduced to the water storage unit. First flush diverters shall:

1. Be placed after prefiltration;

2. Operate automatically and not rely on mechanically operated valves or devices;

3. Discharge diverted rainwater in a manner consistent with local stormwater runoff requirements so as not to cause damage to a property or erosion; and

4. Be readily accessible for maintenance.

I. Inlets and outlets on the water storage unit shall be installed and supported in accordance with the manufacturer's instructions. Water storage units, including units used in series, shall each be fitted as follows:

1. Rainwater inlets to a water storage unit shall be arranged to minimize turbulent flow by means of a calming device such as a return bend elbow pointed upward at least 10 cm above the bottom of the tank.

2. Outlets shall be positioned, and floating collared offtakes shall be used below the top water level in the unit to draw water from the cleanest strata of the unit.

3. Overflow outlets or flap valves shall be protected with a screen having openings no greater than 1.5 mm to prevent entrance of insects or vermin into the unit.

4. The vent shall be minimum 38.1 mm diameter and be protected with mesh having openings no greater than 1.5 mm to prevent entrance of vermin and particulates.

5. Rainwater outlets and pump suction shall be located at least 100 mm above the bottom of the unit. If a floating pump is used, it shall draw water from below the water surface.

6. Pipe penetrations through unit walls shall be watertight and shall comply with the USBC. Pipe penetrations shall not prevent access to the unit for inspection or cleaning.

J. A rainwater harvesting system shall be equipped with filtration systems conforming to the standards specified in 12VAC5-635-250 and 12VAC5-635-340 and shall:

1. Be installed in accordance with the USBC;

2. Be accessible for inspection and maintenance;

3. Provide indication when servicing or replacement is due; and

4. Incorporate shutoff valves immediately upstream and downstream to allow for isolation during maintenance.

K. A rainwater harvesting system shall be equipped with disinfection systems that:

1. Conform with the standards specified in 12VAC5-635-260 and 12VAC5-635-340; and

2. Are designed and installed in accordance with the manufacturer's instructions and the USBC.

L. A rainwater harvesting system for Tier 3 and Tier 4 end use shall be equipped with a fail-safe system for disinfection systems, with alerts and alarms as follows:

1. Alerts shall be provided for critical control points identified in the operation and maintenance manual to indicate when the rainwater harvesting system is operating outside design parameters but not causing a hazard to health or safety or damage to system components.

2. Alerts shall have a visible output and may have an audible output.

3. Alarms shall be provided for critical control points identified in the operation and maintenance manual to indicate when the rainwater harvesting system is operating outside the design parameters and potentially causing a hazard to health or safety or damage to system components.

4. Alarms shall have visible and audible outputs.

5. A remote alarm of an alert system using electronic communication shall be used to notify the operator that the system has failed or that failure is imminent.

M. Separation shall be maintained between potable and nonpotable distribution systems by means of color coded and labeled piping and cross-connection control in accordance with the USBC.

N. Controls for rainwater harvesting systems supplying water for fire sprinkler systems or standpipes shall comply with the Virginia Statewide Fire Prevention Code Act (§ 27-94 et seq. of the Code of Virginia).

O. If a rainwater harvesting system is installed in any building, facility, or residence, it shall be so indicated as follows:

1. Fixtures not specifically treated for potable water use shall be labeled for nonpotable use in accordance with the USBC.

2. Fixtures not subject to the USBC and not specifically treated for potable water use shall be prominently labeled "CAUTION: NONPOTABLE WATER – DO NOT DRINK" and "ATTENCIÓN: AGUA NO-POTABLE – NO BEBER." Labels shall be indelibly printed on a tag or sign constructed of a corrosion resistant, waterproof material permanently mounted in a visible location. The letters of the labels and markings shall be at least 0.5 inches in height and shall be of a color that contrasts with the background on which they are printed. In addition to the required words, a pictograph consistent with the following shall appear in the tag or sign:

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

12VAC5-635-250 Filtration

A. The owner shall ensure that harvested rainwater for Tier 2, Tier 3, and Tier 4 end uses is filtered.

B. Filtration is not required for Tier 2 end use water used outdoors.

C. If ultraviolet disinfection is used, particulate filtration systems shall be located downstream of the water storage tank and upstream of the ultraviolet system.

D. If ozone or chemical based disinfection is used, particulate filtration systems shall be installed downstream of the disinfection equipment. Filtration shall be installed as required for the disinfection system and in accordance with manufacturer's installation requirements.

E. Filters shall be sized to extend service time and shall be labeled to demonstrate compliance with NSF 42 for the reduction of taste or odor or shall be labeled to demonstrate compliance with NSF 53 for organic and cyst removal based on the end use tier.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

12VAC5-635-260 Disinfection

A. The owner shall ensure that harvested rainwater intended for Tier 2, 3, or 4 end use is disinfected and that water meeting the quality standards in 12VAC5-635-310 is delivered to the point of use.

B. The owner shall ensure that disinfection systems are designed and installed in accordance with the manufacturer's instructions and the USBC.

C. If a rainwater harvesting system requires a disinfection system pursuant to this section, the owner shall use one of the following acceptable methods:

1. An ultraviolet (UV) disinfection system that (i) treats water for distribution downstream of the water storage unit and upstream of the point of use; (ii) is sized based on the required dose, taking into consideration the design flow and minimum UV transmittance required to achieve the end use tier standard; and (iii) for Tier 4 end use, is labeled to be certified to Class A of NSF 55;

2. An ozone disinfection system that maintains adequate contact time based on end use tier and off-gasses to a safe environment; or

3. A chemical system that:

a. Has means to measure and control the disinfection and oxidation levels to achieve the performance requirements in 12VAC5-635-310;

b. Uses chemical feed pumps that are controlled to prevent operation unless there is flow through the system;

c. Is labeled to be certified to provide the required log reductions for protozoa and bacteria pursuant to NSF 53 or is labeled to be certified to provide the required log reductions for protozoa and bacteria pursuant NSF/ANSI 419-2018;

d. Uses chemicals that are labeled to demonstrate compliance with NSF/ANSI/CAN Standard 60-2020 if water is provided for Tier 4 end use; and

e. Maintains a chlorine residual of at least 0.5 mg/L and control disinfection byproducts if untreated harvested rainwater is stored at temperatures higher than 77°F and chlorine disinfection is used.

D. A rainwater harvesting system for end use in a single-family home shall only use ultraviolet or ozone disinfection methods.

E. The department may approve other disinfection methods on a case-by-case basis.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

12VAC5-635-270 General certification

A. Premanufactured treatment systems and equipment and materials used to assemble treatment systems that are not premanufactured shall be labeled to demonstrate that the systems, equipment, and materials comply with NSF standards, as follows:

1. NSF/ANSI 53-2020 for point-of-entry or point-of-use filtration systems;

2. NSF/ANSI 55-2020 for ultraviolet disinfection systems;

3. NSF/ANSI/CAN 60-2020 for water treatment chemicals;

4. NSF/ANSI/CAN 61-2020 for protective barrier materials, joining and sealing materials, mechanical devices, plumbing devices, pipes, hoses, pipe fittings, process media, and nonmetallic potable water materials; and

5. NSF/ANSI 350-2020 and NSF/ANSI/CAN 350.1-2017 for material, design, construction, and performance requirements for reuse water.

B. Harvested rainwater is not reuse water. However, NSF/ANSI 350-2020 and NSF/ANSI/CAN 350.1-2017 establish baseline standards suitable for equipment and materials used in the design, installation, and operation of rainwater harvesting systems.

C. A person providing design, installation, or inspection of rainwater harvesting systems shall be certified by the American Society of Sanitary Engineering (ASSE) as follows:

1. Rainwater Harvesting System Designers shall maintain ASSE 21120 Rainwater Catchment Systems Designer certification.

2. Rainwater Harvesting System Installers shall maintain ASSE 21110 Rainwater Catchment Systems Installer certification.

3. Rainwater Harvesting System Inspectors shall maintain ASSE 21130 Rainwater and Stormwater Catchment Systems Inspector certification.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

12VAC5-635-280 Temporary removal from service

If a rainwater harvesting system is seasonally or temporarily removed from service, the owner or operator shall:

1. Lock out or disable piping connected to a waterworks;

2. Secure water storage units from unauthorized access;

3. Divert inlet piping as necessary; and

4. Disconnect electrical power.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

Part VI Performance Requirements

12VAC5-635-290 Performance requirements; general

A. The owner shall ensure that a rainwater harvesting system operates in compliance with the following performance requirements:

1. For a rainwater harvesting system designed to supply water for Tier 2, 3, or 4 end use, the owner or operator shall conduct treatment using a combination of filtration and disinfection technologies to the minimum standards described in 12VAC5-635-310.

2. If a rainwater harvesting system provides water for multiple end uses and treatment is not separated by end use, the highest treatment standard shall apply for all uses.

3. If a rainwater harvesting system provides water for multiple end uses and treatment is separated by end use, connection to distribution for each end use shall comply with the USBC.

B. The designer of a rainwater harvesting system shall consider the following factors:

1. The anticipated harvested rainwater characteristics and flow, including consideration of extremes of precipitation patterns. Excess precipitation not captured for storage shall be discharged as runoff. Insufficient precipitation that does not allow a rainwater harvesting system permitted for Tier 2, 3, or 4 end use to maintain sufficient storage shall be managed as described in 12VAC5-635-300.

2. The prevention of potentially harmful precipitation, such as that which could incorporate particulates from fires, from being captured and contained in the system.

3. The selection and sizing of components of sufficient structural integrity to minimize the potential of physical harm to humans and animals.

4. The sizing of the system in recognition of both the available collection area and number of users of the harvested rainwater. The designer of a Tier 4 rainwater harvesting system shall size the system pursuant to the following criteria:

a. A demand of 100 gallons per bedroom per day for residential systems using either a private well or public water for continuity of water supply pursuant to 12VAC5-635-300 C.

b. A demand of 150 gallons per bedroom per day for residential systems using hauled water for continuity of water supply pursuant to 12VAC5-635-300 C.

c. For nonresidential systems, the designer shall provide calculations supporting the anticipated demand.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

12VAC5-635-300 Continuity of water supply

A. "Continuity of water supply" means that a continuous supply of water can be provided to a distribution system supplied by a rainwater harvesting system in the event of insufficient precipitation or other circumstances affecting the supply of harvested rainwater.

B. If a rainwater harvesting system serves as a secondary supply for a distribution system and the primary supply is a waterworks, the rainwater harvesting system shall be an auxiliary water system pursuant to the requirements of the USBC and 12VAC5-590.

C. If a rainwater harvesting system serves as a primary supply for a distribution system for a Tier 2, 3, or 4 end use, the owner shall provide a secondary water supply by a waterworks, a Class III private well, or commercially hauled water meeting pure water standards.

D. The owner shall supply a secondary water supply from a waterworks or private well by a means to refill the water storage unit or a bypass that provides water directly to the distribution system.

E. The owner may only use commercially hauled water to refill a water storage unit prior to filtration and treatment.

F. When water from a secondary water supply is added to a water storage unit, the owner shall ensure that the water is introduced through a reverse pressure principle backflow device or an air gap pursuant to the USBC.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

12VAC5-635-310 Water quality standards

A. The owner shall perform initial water quality testing before the use of water from the rainwater harvesting system and subsequent water quality sampling and testing consistent with the schedule in 12VAC5-635-320 and in accordance with the operation and maintenance manual requirements of this chapter.

B. The owner shall:

1. Flush the system at least once with treated harvested rainwater before water quality testing and discharge the flush water as wastewater;

2. Collect samples for water quality testing from a point-of-use outlet intended for regular use, such as a kitchen sink;

3. Collect first draw samples of one liter for lead testing;

4. Ensure that water quality samples are analyzed by a laboratory certified by the Division of Consolidated Laboratory Services for drinking water samples; and

5. Ensure that the water is tested in accordance with the minimum performance criteria in Tables 3 and 4 and, at minimum, for total coliform or E. coli present, total nitrate and nitrite content, pH, and lead content.

| TABLE 3 Minimum Performance Requirements | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | Application | Log Reduction Target | | | | | | | | End Use Tier | Category | Potential for Human Contact | Example Use | Viruses | Bacteria | Protozoa | pH | | 1 | Nonpotable | Low | Trap primers Spray irrigation (restricted access) Surface and subsurface irrigation Ice rinks | 0* | 0 | 0 | N/A | | 2 | Nonpotable | Medium | Toilet and urinal flushing Clothes washing HVAC evaporative cooling Rooftop thermal cooling | 0* | 2 log | 2 log | N/A | | 3 | Nonpotable | High | Hose bibs Pressure washing Decorative fountains Vehicle washing Spray irrigation (nonrestricted access) Firefighting or protection and fire suppression | 0* | 3 log | 3 log | N/A | | 4 | Potable | High | Human consumption | 0* | 6 log | 6 log | 7-10.5 | | * It is unlikely that human infectious viruses are present in harvested rainwater. However, if underground water storage tanks are used where there is a potential for sewage contamination or surface water infiltration, a 4-log reduction for viruses shall be required. | | | | | | | |

| TABLE 4 Requirements for Tier 4 Potable Water | | | --- | --- | | Design Standards | | | Filtration | 5 µm | | Disinfection | 40 mi/cm² and labeled certified to Class A of NSF/ANSI 55 | | Water Quality Parameters | | | Turbidity | <0.3 NTU | | Lead | <15 µg/L | | Nitrates | <10 mg/L |

C. Before the commissioner issues an operation permit for a rainwater harvesting system intended for Tier 4 use, the owner must document that the treated harvested rainwater has been tested and meets primary U.S. Environmental Protection Agency drinking water standards (inorganic), the tests listed in subdivision B 5 of this section, and the tests listed in Table 4. If a primary drinking water standard or design standard is exceeded, the owner may provide additional treatment to address the exceedance and shall resample the treated harvest rainwater to ensure compliance with this subsection. Testing for inorganic primary drinking water standards shall not be required for subsequent monitoring unless specified in the operation and maintenance manual prepared pursuant to 12VAC5-635-350.

D. The owner shall conduct water quality sampling and monitoring in accordance with the procedures approved under 40 CFR Part 136 or alternative methods approved by the department, unless other procedures have been specified in this chapter.

E. The designer shall identify the rainwater harvesting system's water quality sampling points, which shall be downstream of the treatment steps and upstream of the point of use. If total residual chlorine is used to measure compliance in a system using chlorine disinfection, the sampling point must be downstream of the chlorine contact tank. If ultraviolet (UV) disinfection is used, the owner may not use water samples collected upstream of UV disinfection units for dosage adjustment for the purposes of water quality testing pursuant to this section.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024; Errata, 43:5 VA.R. 555 October 19, 2026.

Part V Operation and Maintenance Requirements

12VAC5-635-320 Operator requirements; frequency of inspection

A. The owner of a rainwater harvesting system shall ensure that the rainwater harvesting system is inspected by an operator in accordance with Table 5.

| TABLE 5 Minimum operator visit frequency for rainwater harvesting systems | | | | --- | --- | --- | | End Use Tier | Initial Inspection | Regular Inspection Schedule | | 1 | Prior to the system entering service | As needed | | 2, 3 | Prior to the system entering service | Every 12 months while structure is occupied. If system only provides water for outdoor use, then as needed | | 4 (single service connection) | Condition of issuance of operation permit | Every 180 calendar days while structure is occupied* | | 4 (multiple service connections) | Condition of issuance of operation permit | Every 90 calendar days while any connection serves an occupied structure* | | *If a structure is vacant longer than the regular inspection cycle in Table 5, an operator shall inspect the rainwater harvesting system prior to the structure becoming reoccupied. | | |

B. The operator shall collect water quality samples from a rainwater harvesting system pursuant to 12VAC5-635-300 during the initial and regular inspections by the operator.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

12VAC5-635-330 Operation and maintenance; operator's responsibility

A. The operator of the rainwater harvesting system shall be certified as a designer, installer, or inspector pursuant to 12VAC5-635-270 C. Nothing in this chapter shall preclude the owner from being an operator if they are appropriately certified.

B. When the operator performs an inspection of the rainwater harvesting system, the operator shall perform the assessments required by this chapter through visual or other observations and through laboratory or other tests as required and may use additional observation methods or tests that the operator deems appropriate.

C. The operator shall maintain a written operational record for each rainwater harvesting system for which the operator is responsible that contains, at minimum, the following items:

1. Results of testing and sampling;

2. Information regarding reportable incidents, including the corrective action required and taken;

3. Maintenance, corrective actions, and repair activities that are performed for purposes other than a reportable incident; and

4. Recommendations for repair and replacement of system components.

D. If the owner of a rainwater harvesting system is not the operator, the operator shall provide an updated copy of the written operational record to the owner each time it is updated and shall document the dates the copies are given to the owner in the written operational record. The operator shall also make an accurate, up-to-date copy of the written operational record available to the department upon request.

E. When performing activities pursuant to an inspection required by this chapter, the operator is responsible for the entire rainwater harvesting system, including treatment components, collection area components, and associated piping.

F. The operator shall follow the procedures and instructions provided in the approved operation and maintenance manual for the rainwater harvesting system.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

12VAC5-635-340 Operation and maintenance; owner's responsibilities

The owner shall:

1. Ensure the rainwater harvesting system is operated and maintained by a qualified operator;

2. Ensure that the operator performs the required duties;

3. Maintain a copy of the written operational record provided by the operator on the property where the rainwater harvesting system is located, make the written operational record available to the department upon request, and make a reasonable effort to transfer the written operational record to the subsequent owner;

4. Follow the approved operation and maintenance manual and keep a copy of the operation and maintenance manual for the rainwater harvesting system on the property where the system is located, make the operation and maintenance manual available to the department upon request, and make a reasonable effort to transfer the operation and maintenance manual to the subsequent owner;

5. Comply with applicable rainwater harvesting system requirements contained in this chapter; and

6. If applicable, inform users of the system of reportable incidents.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

12VAC5-635-350 Operation and maintenance manual

A. The owner and operator shall maintain and operate a rainwater harvesting system in accordance with the approved operation and maintenance manual.

B. The manual shall be easily understandable to the owner and operator and include, at minimum, the following items:

1. Basic identifying information for the rainwater harvesting system, including the location and intended end use;

2. Basic information regarding the rainwater harvesting system design, including treatment unit capacity, a list of components in the system, a schematic of the system, sampling locations, and contact information for replacement parts for each unit;

3. A list of control functions and how to use them;

4. Operation, maintenance, sampling, inspection, and reporting schedules for the rainwater harvesting system;

5. The design limits of the rainwater harvesting system design and how to operate the system within those design limits;

6. Technical information, including:

a. Catchment area dimensions;

b. Roofing materials and sealants;

c. Vertical conveyance materials;

d. Water storage unit information including volume, size dimensions, whether the unit is covered or uncovered, whether the unit is above or below ground, construction materials, and location;

e. Prefiltration information, including type of prefiltration used, quantity, filtration particle size, and location;

f. Pump system information including the brand, make, model, capacity and heads, and horsepower;

g. Disinfection system information, including the brand, make, model, parts numbers, date of manufacture, and date of installation for each component;

h. Additional manufacturer's instructions, such as schematics and diagrams provided with components of the rainwater harvesting system; and

i. Water quality verification procedures, frequency, parameters, sampling locations, records policies and procedures, and a sample written operational record entry form;

7. Inspection and maintenance procedures, to include (i) the procedures for inspecting and cleaning water storage tanks and piping and (ii) periodic cross-connection inspection; and

8. Other information deemed necessary or appropriate by the designer.

C. The operation and maintenance manual for a Tier 4 rainwater harvesting system shall also contain the following:

1. A list of water quality monitoring requirements, including sample locations, tests to be performed, testing methods, and the applicable water quality standard;

2. Provisions for the determination of temporary or emergency alternate water supply, the conditions under which an alternate water supply is required, the procedures for ensuring continuity of water supply, when bottled water should be used, and the conditions that require boil water practices for cooking and drinking;

3. Criteria for ensuring the continuity of water supply, to include (i) a low capacity alarm for water storage; (ii) bypass protocol, including backflow and cross-connection prevention; and (iii) applicable reporting criteria;

4. Provisions for documenting the easement and land records requirements of this chapter; and

5. Identification of what incidents qualify as a reportable incident and the appropriate response, including:

a. An alarm event lasting more than 24 hours;

b. An alarm event that reoccurs following corrective action;

c. Failure to achieve one or more performance requirements;

d. Failure to achieve one or more quality standards;

e. Replacement of a major component of the system, including electric and electronic components; and

f. Actual or suspected contamination.

D. If the operation and maintenance manual includes requirements for operation, maintenance, sampling, or inspection schedules that exceed the minimum requirements of this chapter, the designer shall determine the additional requirements based on the proposed end use of the harvested rainwater, design flow and unit treatment processes of the rainwater harvesting system, and other factors.

E. The operation and maintenance manual shall include regional, local, and site-specific water concerns.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

12VAC5-635-360 Inspection requirements

A. During an inspection, the operator shall review and evaluate the operation of the rainwater harvesting system, perform routine maintenance, make adjustments, and replace worn or dysfunctional components with functionally equivalent parts such that the system can reasonably be expected to return to normal operation.

B. If a Tier 4 rainwater harvesting system is not functioning as designed or in accordance with the performance requirements of this chapter and, in the operator's professional judgment, cannot be reasonably expected to return to normal operation through routine operation and maintenance, the operator shall report immediately to the owner the remediation efforts necessary to return the rainwater harvesting system to normal operation, including recommendation for temporary or emergency alternate water supply, if the system does not provide water acceptable for human consumption.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

12VAC5-635-370 Inspection reports

A. For an inspection conducted for a rainwater harvesting system intended for Tier 2 or 3 end use, the operator shall document the observations and findings of the inspection and provide documentation to the department if requested by the department.

B. For an inspection conducted for a Tier 4 rainwater harvesting system, the operator shall file an inspection report with the local health department in the locality where the rainwater harvesting system is located. The report shall be filed no later than 45 calendar days following the date on which the inspection occurred and shall include the following minimum elements:

1. The name and certification number of the operator;

2. The date and time of the inspection;

3. The purpose of the inspection, such as required inspection, follow-up, or reportable incident;

4. A summary stating:

a. Whether the rainwater harvesting system is functioning as designed and in accordance with the performance requirements of this chapter;

b. Whether the operator believes the rainwater harvesting system will return to normal operation after providing maintenance; or

c. If the rainwater harvesting system is not functioning as designed or in accordance with the performance requirements of this chapter, (i) the actions required to return the rainwater harvesting system to normal operation, including provisions for a temporary alternate water supply, if applicable; and (ii) that the owner has been advised that failure to take action to return the system to normal operation represents a risk to public health and may subject the owner to enforcement action from the department;

5. Maintenance performed or adjustments made, including parts replaced;

6. The results of field measurements, water quality sampling, and observations;

7. The name of the laboratory that analyzed samples; and

8. A statement certifying the date the operator provided a written copy of the report to the owner.

C. If actions are required by the owner to return a Tier 4 rainwater harvesting system to normal operation or provide a temporary alternate water supply or the operator has identified that failure to repair the rainwater harvesting system may result in a hazard to public health or the environment, the operator shall file the report summary with the local health department within 24 hours of the inspection.

History

• Statutory Authority: §§ 32.1-12 and 32.1-248.2 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. November 20, 2024.

Chapter 640 Alternative Discharging Sewage Treatment Regulations for Individual Single Family Dwellings

Part I General Provisions

12VAC5-640-5 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Agent" means a legally authorized representative of the owner.

"All weather stream" means any stream that will, at all times, dilute point source discharge effluent from a pipe at least 10:1 as measured during a seven consecutive day average of a 10-year low flow (7-Q-10).

"Alternative discharging sewage treatment system" or "discharging system" means any device or system that results in a point source discharge of treated sewage for which the board may issue a permit authorizing construction and operation when such system is regulated by the SWCB pursuant to a general VPDES permit issued for an individual single family dwelling with flows less than or equal to 1,000 gallons per day on a monthly average.

"Alternative onsite sewage treatment system" means a treatment works that is not a conventional onsite sewage system and does not result in a point source discharge.

"Biochemical oxygen demand, five day" or "BOD₅" means the quantitative measure of the amount of oxygen consumed by bacteria while stabilizing, digesting, or treating biodegradable organic matter under aerobic conditions over a five-day incubation period; BOD₅ is expressed in milligrams per liter (mg/l).

"Biological treatment unit" means a method, technique, equipment, or process other than a septic tank or septic tanks that uses biological organisms to treat sewage to produce effluent of a specified quality.

"Board" means the State Board of Health.

"Combined Application" means a Virginia Department of Health Discharging System Application Form for Single Family Dwellings Discharging Sewage Less Than or Equal to 1,000 Gallons Per Day and a State Water Control Board Virginia Pollutant Discharge Elimination System General Permit Registration Statement for Domestic Sewage Discharges Less Than or Equal to 1,000 Gallons Per Day.

"Commissioner" means the State Health Commissioner or his subordinate who has been delegated powers in accordance with subdivision 2 of 12VAC5-640-80.

"Conventional onsite sewage system" means a treatment works consisting of one or more septic tanks with gravity, pumped, or siphoned conveyance to a gravity distributed subsurface drainfield.

"Dechlorination" means a process that neutralizes chlorine in the final effluent.

"Department" means the district or local health department with jurisdiction over the site or proposed site of the alternative discharging sewage treatment system.

"Disinfection" means a process used to destroy or inactivate pathogenic microorganisms in wastewater to render them noninfectious.

"Disinfection unit" means a separate treatment component that disinfects wastewater.

"District health department" means a consolidation of local health departments as authorized in § 32.1-31 C of the Code of Virginia.

"Division" means the Division of Onsite Sewage, Water Services, Environmental Engineering, and Marina Programs.

"Dry ditch" means a naturally occurring swale or channel that is topographically connected to an all weather stream. In some cases, a dry ditch may have a manmade component that provides a topographical connection to an existing, naturally occurring swale or channel. A dry ditch may have observable flow during or immediately after a storm event or snow melt. For the purposes of this chapter, all dry ditches shall have a well defined natural channel with sides that have at least a 1:10 (rise:run) slope.

"Emergency pump and haul" means an emergency condition to pump out the treatment systems tanks by a licensed sewage handler as needed to not allow a discharge to protect public health and the environment.

"Failing alternative discharging sewage treatment system" means any alternative discharging sewage treatment system that discharges effluent having a BOD_5,total suspended solids, pH, chlorine residual, dissolved oxygen, or bacteria value that is out of compliance with the General Permit or fails to comply with 12VAC5-640-430. The failure to discharge due to exfiltration may indicate system failure.

"Failing onsite sewage disposal system" means an onsite sewage disposal system where the presence of raw or partially treated sewage on the ground's surface or in adjacent ditches or waterways or exposure to insects, animals, or humans is prima facie evidence of a system failure. Pollution of the groundwater or backup of sewage into plumbing fixtures may also indicate system failure.

"General approval" means that a treatment unit has been evaluated and approved for TL-2 effluent or TL-3 effluent in accordance with the requirements of this chapter and 12VAC5-610.

"General Permit" means a Virginia Pollutant Discharge Elimination System (VPDES) General Permit for domestic sewage discharges less than or equal to 1,000 gallons per day on a monthly average issued by the State Water Control Board.

"Intermittent stream" means any stream that will not, at all times, dilute point source discharge effluent at least 10:1 as measured during a seven consecutive day average of a 10-year low flow (7-Q-10). For the purposes of this section, an intermittent stream is identified as a dashed or dotted line on a United States Geological Survey 7.5 minute topographic map or an all weather stream that provides less than 10:1 dilution of the effluent based on 7-Q-10 flow.

"Local health department" means the department established in each city and county in accordance with § 32.1-30 of the Code of Virginia.

"Maintenance" means performing adjustments to equipment and controls and in-kind replacement of normal wear and tear parts such as light bulbs, fuses, filters, pumps, motors, or other like components. Maintenance includes pumping the tanks or cleaning the building sewer on a periodic basis.

"Modify" means to alter a treatment works, excluding actions taken to "operate" the treatment works and "maintenance" activities as those terms are defined in § 32.1-163 of the Code of Virginia.

"National Pollutant Discharge Elimination System" or "NPDES" means the national program for (i) issuing, modifying, revoking and reissuing, terminating, monitoring, and enforcing permits and (ii) imposing and enforcing pretreatment requirements under §§ 307, 402, 318, and 405 of the Clean Water Act (33 USC § 1251 et seq.). The term includes an approved program.

"Operate" means the act of making a decision on one's own volition to (i) place into or take out of service a unit process or unit processes or (ii) make or cause adjustments in the operation of a unit process at a treatment works.

"Operation" means the biological, chemical, and mechanical processes of transforming sewage or wastewater to compounds or elements and water that no longer possess an adverse environmental or health impact.

"Operation and maintenance contract" means an agreement between an owner and a licensed operator that the operator will provide services to operate, maintain, monitor, repair, and report on the treatment system in accordance with this chapter.

"Owner" means the Commonwealth or any of its political subdivisions, including sanitary districts, sanitation district commissions and authorities, or any individual, any group of individuals acting individually or as a group, or any public or private institution, corporation, company, partnership, firm, or association that owns or proposes to own a sewerage system or treatment works.

"Person" means any and all persons, including individuals, firms, partnerships, associations, public or private institutions, municipalities or political subdivisions, governmental agencies, or private or public corporations organized under the law of this Commonwealth or any other state or country.

"Point source discharge" means any discernible, confined, and discrete conveyance including, but not limited to, any pipe, ditch, channel, tunnel, conduit, well, discrete fissure, container, rolling stock, concentrated animal feeding operation, landfill leachate collection system, vessel, or other floating craft from which pollutants are or may be discharged. This term does not include return flows from irrigated agriculture or agricultural stormwater run-off.

"Post-aeration unit" means a treatment component that is designed to add oxygen to an effluent.

"Post-filtration unit" means a treatment component that physically removes total suspended solids.

"Reliability" means a measure of the ability of a component or system to perform its designated function without failure or interruption of service. Overflow criteria, such as an allowable period of a noncompliant discharge, are utilized solely for the establishment of reliability classification for design purposes and are not to be construed as authorization for, or defense of, an unpermitted discharge to state waters. The reliability classification shall be based on the water quality and public health and welfare consequences of a component or system failure.

"Reliability Class I" means a measure of reliability that requires a treatment system design to provide continuous satisfactory operation during power failures, flooding, peak loads, equipment failure, and maintenance shut-down. For the purposes of this chapter, continuous operability shall be defined as restoring proper operation or otherwise eliminating the out-of-compliance discharge within 24 hours. This class includes design features, such as additional electrical power sources, additional flow storage capacity, and additional treatment units that provide operation in accordance with the issued permit requirements.

"Reliability Class II" means a measure of reliability that requires a treatment design that limits out-of-compliance discharges due to power failures, flooding, peak loads, equipment failure, and maintenance shut-down to less than 36 hours. This class includes design features such as alarms with telemetry to the operator, additional treatment units, or additional flow storage capacity that provide operation in accordance with the issued permit requirements.

"Reliability Class III" means a measure of reliability that requires a treatment design that limits out-of-compliance discharges due to power failures, flooding, peak loads, equipment failure, and maintenance shut-down to less than 48 hours. This class includes design features such as onsite alarms and owner initiated operator notification to address the alarm condition to provide operation in accordance with the issued permit requirements.

"Sanitary survey" means an investigation of any condition that may affect public health.

"Sewage" means water carried and non-water carried human excrement, kitchen, laundry, shower, bath, or lavatory wastes separately or together with such underground, surface, storm, and other water and liquid industrial wastes as may be present from residences, buildings, vehicles, industrial establishments, or other places.

"Site sketch" means a scale drawing of a proposed site for a discharge system, with pertinent distances shown. The scale shall typically be 1" = 50' for lots of three acres or less and 1" = 100' for larger lots. Site sketches may be made by the homeowner or any agent for the homeowner.

"Surface waters" means:

1. All waters that are currently used, were used in the past, or may be susceptible to use in interstate or foreign commerce, including all waters that are subject to the ebb and flow of the tide;

2. All interstate waters, including interstate wetlands;

3. All other waters such as intrastate lakes, rivers, streams (including intermittent streams), mudflats, sandflats, wetlands, sloughs, prairie potholes, wet meadows, playa lakes, or natural ponds and the use, degradation, or destruction of which would affect or could affect interstate or foreign commerce including any such waters:

a. That are or could be used by interstate or foreign travelers for recreational or other purposes;

b. From which fish or shellfish are or could be taken and sold in interstate or foreign commerce; or

c. That are used or could be used for industrial purposes by industries in interstate commerce;

4. All impoundments of waters otherwise defined as surface waters under this definition;

5. Tributaries of waters identified in subdivisions 1 through 4 of this definition;

6. The territorial sea; and

7. Wetlands adjacent to waters, other than water that are themselves wetlands, identified in subdivisions 1 through 6 of this definition.

"SWCB" means the State Water Control Board and its designees.

"Total residual chlorine" or "TRC" means a measurement of the combined available chlorine and the free available chlorine available in a sample after a specified contact time.

"Total suspended solids" or "TSS" means solids in effluent samples that can be removed readily by standard filtering procedures in a laboratory and expressed as mg/l.

"Treatment level 2 effluent" or "TL-2 effluent" means effluent that has been treated to produce BOD₅and TSS concentrations less than or equal to 30 mg/l each.

"Treatment level 3 effluent" or "TL-3 effluent" means effluent that has been treated to produce BOD₅ and TSS concentrations less than or equal to 10 mg/l each.

"Treatment system" means the combination of treatment components that together produce the required quality of effluent.

"Variance" means a conditional waiver of a specific regulation that is granted to a specific owner relating to a specific situation or facility and may be for a specified time period.

"VPDES permit" means a Virginia Pollutant Discharge Elimination System permit issued by the SWCB under the authority of the federal NPDES program.

"Water well" or "well" means any artificial opening or artificially altered natural opening, however made, by which groundwater is sought or through which groundwater flows under natural pressure or is intended to be artificially drawn. This definition shall not include wells drilled for the following purposes: (i) exploration or production of oil or gas, (ii) building foundation investigation and construction, (iii) elevator shafts, (iv) grounding of electrical apparatus, or (v) the modification or development of springs.

"Wetlands" means those areas that are inundated or saturated by surface water or groundwater at a frequency and duration sufficient to support, and that under normal circumstances do support, a prevalence of vegetation typically adapted for life in saturated soil conditions. Wetlands generally include swamps, marshes, bogs, and similar areas.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-10 (Repealed.)

History

• Historical Notes: Derived from VR355-34-400 § 1.1, eff. July 30, 1992; repealed, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-20 Purpose of regulations

Title 32.1 of the Code of Virginia and specifically §§ 32.1-12, 32.1-163, and 32.1-164 of the Code of Virginia provide that the board has the duty to protect the public health and the environment. In order to discharge this duty, the board is empowered to supervise and regulate the construction, location, and operation of alternative discharging sewage treatment systems with flows less than or equal to 1,000 gallons per day on a monthly average for an individual single family dwelling within the Commonwealth when such a system is regulated by the Virginia State Water Control Board pursuant to a Virginia Pollutant Discharge Elimination System General Permit.

These regulations have been promulgated by the State Board of Health to:

1. Ensure that discharging systems are permitted, constructed, and operated in a manner which protects the environment and protects the public welfare, safety and health;

2. Guide the commissioner in his determination of whether a permit for construction and operation of a discharging system should be issued or denied;

3. Guide the owner or his agent in the requirements necessary to secure a permit for construction of a discharging system;

4. Guide the owner or his agent in the requirements necessary to secure an operation permit following construction;

5. Guide the owner or his agent in the requirements necessary to operate and maintain a discharging system;

6. Guide the commissioner in his determination of whether a discharging system is being operated in a manner which protects public health and the environment; and

7. Guide the commissioner in his determination of what actions are appropriate to correct violations of this chapter.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 1.3, eff. July 30, 1992; amended Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-30 Scope of regulations

A. This chapter applies to all alternative discharging sewage treatment systems constructed and operated to serve an individual single family dwelling with flows less than or equal to 1,000 gallons per day on a monthly average. This includes the following systems:

1. All new discharging systems described in this subsection when such systems are regulated by the State Water Control Board pursuant to a General Permit.

2. All existing discharging sewage treatment systems, as described in this subsection, constructed prior to July 30, 1992, and permitted by the State Water Control Board under its individual VPDES permit program shall be governed by this chapter, except for the monitoring requirements noted in this subdivision, effective upon the expiration date of their individual VPDES permit and approval of the owner's registration statement by the SWCB under the General Permit. Upon approval under the General Permit, the owners of such systems need only comply with the monitoring requirements of the General Permit and the monitoring requirements in 12VAC5-640-510, and not 12VAC5-640-490 and 12VAC5-640-500, until (i) a change in ownership or (ii) the discharging system violates the effluent limitations of the General Permit for two consecutive quarters, whichever occurs first. After either event, the owner shall comply with 12VAC5-640-490 and 12VAC5-640-500.

3. All existing discharging sewage treatment systems as described in this subsection that were operating without a valid VPDES permit on July 30, 1992, shall be governed by this chapter after the owner receives registration statement approval from the SWCB under the General Permit.

B. Location criteria contained in this chapter shall not apply to systems legally installed prior to July 30, 1992. When extensive repairs, modifications, or replacement are required to bring a system into compliance with the discharge requirements of the General Permit, a construction permit and temporary operation permit must be obtained by the system owner. The construction permit and temporary operation permit shall be valid for the time specified on its face, at which time the repairs, modifications, or replacement must be completed.

C. Requirements for an operation and maintenance manual contained in this chapter shall only apply to alternative discharging systems with construction applications filed on or after December 16, 2015.

D. The department will not consider issuance of a permit to construct a discharging system, unless all options for conventional and alternative onsite sewage treatment systems have been evaluated and found unsatisfactory in accordance with this section. For the purposes of this section, the consideration of all options means site evaluation(s) conducted by an individual licensed in Virginia to evaluate and design onsite sewage systems such as an onsite soil evaluator or professional engineer indicating that no sewage disposal site exists on that property for the site and soil conditions allowed under the Sewage Handling and Disposal Regulations (12VAC5-610) or its successor including the use of TL-2 and TL-3 effluent to reduce footprint area as allowed under 12VAC5-613 or its successor. All evaluations must be completed in accordance with the methods and requirements of 12VAC5-610 and 12VAC5-613.

E. Pursuant to § 32.1-163.6 of the Code of Virginia, this chapter establishes performance requirements and horizontal setbacks for alternative discharging systems that are necessary to protect public health and the environment.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 1.3, eff. July 30, 1992; amended, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-40 Relationship to the Virginia Sewage Handling and Disposal Regulations

This chapter is supplemental to the Sewage Handling and Disposal Regulations (12VAC5-610) or its successor that govern the treatment and disposal of sewage utilizing onsite systems. The Sewage Handling and Disposal Regulations shall govern the materials and construction practices used to install alternative discharging sewage treatment systems and all appurtenances associated with systems including but not limited to pipes and fittings whenever specifications are not contained in this chapter.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 1.4, eff. July 30, 1992; amended, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-50 (Repealed.)

History

• Historical Notes: Derived from VR355-34-400 § 1.5, eff. July 30, 1992; repealed, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-60 Relationship to the State Water Control Board

This chapter contains administrative procedures and construction, location, monitoring and maintenance requirements which are supplementary to the State Water Control Board's VPDES General Permit Regulation for domestic sewage discharges less than or equal to 1,000 gallons per day. This chapter applies only to individual single family dwellings with flows less than or equal to 1,000 gallons per day on a monthly average registered under this General Permit. Single family dwellings are a subset of the systems regulated by the State Water Control Board under this General Permit.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 1.6, eff. July 30, 1992; amended, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-70 Relationship to the Uniform Statewide Building Code

This chapter is independent of, and in addition to, the requirements of the Virginia Uniform Statewide Building Code (13VAC5-63). All persons having obtained a construction permit under this chapter shall furnish a copy of the permit to the local building official, upon request, when making application for a building permit. Prior to obtaining an occupancy permit, an applicant shall furnish the local building official with a copy of the operation permit demonstrating the system has been inspected and approved by the department.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 1.7, eff. July 30, 1992; amended, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-80 Administration of regulations

This chapter is administered by the following:

1. The State Board of Health has the responsibility to promulgate, amend, and repeal regulations necessary to ensure the proper construction, location, and operation of alternative discharging systems.

2. The commissioner is the chief executive officer of the Virginia Department of Health. The commissioner has the authority to act, within the scope of regulations promulgated by the board, and for the board when it is not in session. The commissioner may delegate his powers under this chapter to any subordinate, with the exception of (i) his power to issue variances under § 32.1-12 of the Code of Virginia and 12VAC5-640-170 and (ii) his power to issue orders under § 32.1-26 of the Code of Virginia and 12VAC5-640-140 and 12VAC5-640-150. The commissioner has final authority to adjudicate contested case decisions of subordinates delegated powers under this section prior to appeal of such case decisions to the circuit court.

3. The Virginia Department of Health is designated as the primary agent of the commissioner for the purpose of administering this chapter.

4. The district or local health departments are responsible for implementing and enforcing the requirements of this chapter.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 1.8, eff. July 30, 1992; amended, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-90 Right of entry and inspections

In accordance with the provisions of §§ 32.1-25 and 32.1-164 of the Code of Virginia, the commissioner or his designee shall have the right to enter any property to ensure compliance with this chapter.

History

• Statutory Authority: §§ 32.1-12, 32.1-163 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 1.9, eff. July 30, 1992.

12VAC5-640-100 (Repealed.)

History

• Historical Notes: Derived from VR355-34-400 § 1.10, eff. July 30, 1992; repealed, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

Part II Procedures

12VAC5-640-110 Compliance with the Administrative Process Act

The provisions of the Virginia Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) shall govern the promulgation and administration of this chapter and shall govern the procedures pertaining to the decisions of cases under this chapter.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 2.1, eff. July 30, 1992; amended, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-120 Powers and procedures of regulations not exclusive

The commissioner may enforce this chapter through any means lawfully available.

History

• Statutory Authority: §§ 32.1-12, 32.1-163 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 2.2, eff. July 30, 1992.

12VAC5-640-130 (Repealed.)

History

• Historical Notes: Derived from VR355-34-400 § 2.3, eff. July 30, 1992; repealed, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-140 Emergency order

If an emergency exists the commissioner may issue an emergency order as is necessary for preservation of public health, safety, and welfare or to protect environmental resources. The emergency order shall state the reasons and precise factual basis upon which the emergency order is issued. The emergency order shall state the time period for which it is effective. Emergency orders will be publicized in a manner deemed appropriate by the commissioner. The provisions of 12VAC5-640-150 shall not apply to emergency orders issued pursuant to this section.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 2.4, eff. July 30, 1992; amended, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-150 Enforcement of regulations

A. Whenever the commissioner or the department notifies a named party of an alleged violation of this chapter, the procedures and content of such notice shall be as follows:

1. Any notice of alleged violation shall be made in writing and shall be delivered personally or sent by certified mail to the named party.

2. The notice shall cite the regulation or regulations that are applicable to the situation.

3. The notice shall state the factual basis for the issuance of the notice.

4. The notice shall include a request for a specific action by the recipient by a specified time.

5. The notice shall include information on the process for obtaining an informal fact finding conference to determine whether or not a violation has occurred.

The issuance of a notice of alleged violation by the commissioner or the department shall not be considered a case decision as defined in § 2.2-4001 of the Code of Virginia. When the commissioner deems it necessary, he may initiate criminal prosecution or seek civil relief through mandamus or injunction prior to giving notice.

B. The commissioner may issue orders in accordance with Title 32.1 (§ 32.1-1 et seq.) of the Code of Virginia to require any owner, or other person, to comply with the provisions of this chapter. The order shall be signed by the commissioner and may require:

1. The immediate cessation and correction of the violation;

2. Appropriate remedial action to ensure that the violation does not recur;

3. The submission of a plan to prevent future violation to the commissioner for review and approval;

4. The submission of an application for a variance; or

5. Any other corrective action deemed necessary for proper compliance with the chapter.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 2.5, eff. July 30, 1992; amended, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-160 Suspension of regulations during disasters

If, in the case of a man-made or natural disaster, the commissioner finds that certain regulations cannot be complied with and that the public health is better served by not fully complying with this chapter, he may authorize the suspension of the application of this chapter for specifically affected localities and institute a provisional regulatory plan until the disaster is abated.

History

• Statutory Authority: §§ 32.1-12, 32.1-163 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 2.6, eff. July 30, 1992.

12VAC5-640-170 Variances

Only the commissioner or the deputy commissioners may grant a variance to this chapter. (See §§ 32.1-12 and 32.1-22 of the Code of Virginia and subdivision 2 of 12VAC5-640-80.) The commissioner or the deputy commissioners shall follow the appropriate procedures set forth in this section in granting a variance.

1. The commissioner may grant a variance if a thorough investigation reveals that the hardship imposed by this chapter outweighs the benefits that may be received by the public. Further, the granting of such a variance shall not subject the public to unreasonable health risks or jeopardize environmental resources.

2. Any owner who seeks a variance shall apply in writing within the time period specified in 12VAC5-640-210 C. The application shall be signed by the owner. The application shall include:

a. A citation to the regulation from which a variance is requested;

b. The nature and duration of the variance requested;

c. Any relevant analytical results including results of relevant tests conducted pursuant to the requirements of this chapter;

d. Statements or evidence why the public health and welfare and environmental resources would not be degraded if the variance were granted;

e. Suggested conditions that might be imposed on the granting of a variance that would limit the detrimental impact on the public health and welfare or environmental resources;

f. Other information, if any, believed pertinent by the applicant; and

g. Such other information as the department or commissioner may require.

3. In the evaluation of a variance application, the commissioner shall consider the following factors:

a. The effect that such a variance would have on the construction, location, or operation of the discharging system;

b. The cost and other economic considerations imposed by this requirement;

c. The effect that such a variance would have on protection of the public health;

d. The effect that such a variance would have on protection of environmental resources; and

e. Such other factors as the commissioner may deem appropriate.

4. The commissioner may grant or deny a variance request in accordance with the requirements of this subdivision.

a. The commissioner may deny any application for a variance by sending a denial notice to the applicant by certified mail. The notice shall be in writing and shall state the reasons for the denial.

b. If the commissioner proposes to grant a variance request submitted pursuant to subdivision 2 of this section, the applicant shall be notified in writing of this decision. Such notice shall identify the variance and the discharging system covered, and shall specify the period of time for which the variance will be effective. The effective date of a variance shall be as stated in the variance.

c. No owner may challenge the terms or conditions set forth in the variance after 30 calendar days have elapsed from the effective date of the variance.

5. All variances granted to any discharging sewage treatment system are transferable from owner to owner unless otherwise stated. Each variance shall be attached to the permit to which it is granted. Each variance is revoked when the permit to which it is attached is revoked.

6. Subject to the time limitations specified in 12VAC5-640-210, informal conference or consultation proceedings or hearings on denials of an application for a variance or on challenges to the terms and conditions of a granted variance may be held pursuant to 12VAC5-640-180 A or B, except that informal conference or consultation proceedings under 12VAC5-640-180 A shall be held before the commissioner or his designee.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 2.7, eff. July 30, 1992; amended, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-180 Informal conferences and formal hearings

A. An informal conference or consultation proceeding is a meeting held in conformance with § 2.2-4019 of the Code of Virginia. The department shall ascertain the fact basis for its decisions of cases through informal conference or consultation proceedings unless the named party and the department consent to waive such a conference or proceeding to go directly to a formal hearing.

B. The adjudicatory hearing is a formal, public adjudicatory proceeding held in conformance with § 2.2-4020 of the Code of Virginia. The commissioner may afford opportunity for an adjudicatory hearing in any case to the extent that informal procedures under § 2.2-4019 and subsection A of this section have failed to dispose of a case by consent.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 2.8, eff. July 30, 1992; amended, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-190 (Repealed.)

History

• Historical Notes: Derived from VR355-34-400 § 2.9, eff. July 30, 1992; repealed, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-200 (Repealed.)

History

• Historical Notes: Derived from VR355-34-400 § 2.10, eff. July 30, 1992; repealed, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-210 Appeals

A. Any appeal from a denial of a construction or operation permit for a discharging system must be made in writing and received by the department within 30 days of the date of the denial.

B. Any appeal from the denial of an application for a variance pursuant to subdivision 4 a of 12VAC5-640-170 must be made in writing and received within 30 days of receipt of the denial notice.

C. Any request for a variance must be made in writing and received by the department prior to the denial of the discharging system permit, or within 30 days after such denial.

D. In the event a person applies for a variance within the 30-day period provided by subsection C of this section, the date for appealing the denial of the permit, pursuant to subsection A of this section, shall commence from the date on which the department acts on the request for a variance.

E. Pursuant to the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) an aggrieved owner may appeal a final decision of the commissioner to an appropriate circuit court.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 2.11, eff. July 30, 1992; amended, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-220 Permits; general

A. No person shall construct, alter, rehabilitate, modify, or extend a discharging system or allow the construction, alteration, rehabilitation, or extension of a discharging system, without a written construction permit from the commissioner or the department. Conditions may be imposed on the issuance of any construction permit and no discharging system shall be constructed in violation of those conditions.

B. Except as provided in 12VAC5-640-30, 12VAC5-640-280, and 12VAC5-640-290, construction permits for a discharging system shall be deemed valid for a period of 60 months from the date of issuance or until the expiration of the General Permit, whichever comes first. The permit to construct may be renewed one time for an additional 18 months if the building permit has been obtained or building construction commenced, the General Permit is reissued, and the effluent requirements of the General Permit are unchanged.

C. Except as provided in 12VAC5-640-30 A 2 and 12VAC5-640-266, no person shall place a discharging system in operation, or cause or allow a discharging system to be placed in operation, without obtaining a written operation permit. Conditions may be imposed on the issuance of any operation permit, and no discharging system shall be operated in violation of those conditions.

D. Except as provided for in 12VAC5-640-280 and 12VAC5-640-290, operation permits shall be valid for a period of time not longer than the General Permit. The operation permit shall remain valid when continued reporting of operation, maintenance, and monitoring occurs in accordance with 12VAC5-640-490, 12VAC5-640-500, and 12VAC5-640-510, provided the facility is otherwise in compliance with this chapter.

E. Construction and operation permits for discharging systems shall not be transferable except as provided in this subsection:

1. A construction permit for a specific discharging system will be issued to a new owner if the new owner (i) applies for the permit transfer on a form approved by the department, (ii) pays the applicable fee, (iii) provides the department with change of ownership documentation in accordance with the General Permit, and (iv) provides written certification that there are no new site conditions that will adversely impact the existing approved construction permit and documents or the original construction application.

2. An operation permit for a specific discharging system will be issued to a new owner if the new owner (i) applies for the permit transfer on a form approved by the department, (ii) pays the applicable fee, and (iii) provides the department with change of ownership documentation in accordance with the General Permit.

3. The expiration date of the transferred operation or construction permit shall not change.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 2.12, eff. July 30, 1992; amended, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-230 Application process for obtaining a Department of Environmental Quality General Permit using the Combined Application

A. The process for obtaining a General Permit consists of (i) filing a Combined Application with fee to determine the suitability of a discharge point, (ii) obtaining confirmation of a suitable discharge point from the department, and (iii) obtaining coverage under the Department of Environmental Quality's General Permit. Once a General Permit registration has been received, the owner shall file an application for a construction permit as described in 12VAC5-640-240 and shall apply for an operation permit in accordance with 12VAC5-640-266 before a discharge is authorized.

B. All requests for review of a suitable discharge point for discharging systems shall be by written application on the Combined Application, signed by the owner or his agent, and shall be directed to the department.

C. An application shall be deemed complete upon receipt by the department of a signed and dated application and the appropriate fee, containing the following information:

1. The property owner's name, address, and telephone number;

2. The applicant's name, address, and phone number (if different from subdivision 1 of this subsection);

3. A statement signed by the property owner, or his agent, granting the department access to the site for the purposes of evaluating the suitability of the site for a discharging system and allowing the department access to inspect the construction, maintenance and operation of the discharging system after it is installed. The applicant must secure and produce written permission for the department to enter on any property necessary to evaluate the application;

4. A site sketch on a survey plat showing the locations of and setback distances from the proposed discharge point and discharging system components to the following:

a. Location of existing or proposed houses and other structures;

b. Property boundaries;

c. Location of proposed discharge point;

d. Existing and proposed wells, springs, cisterns, or other sources of potable water within 200 feet upslope or 1,600 feet downslope of the proposed discharge point;

e. Actual or proposed discharging systems within 600 feet of the proposed discharge point;

f. Recorded and proposed easements;

g. Existing and proposed overhead and buried utilities such as water lines, electrical lines, phone lines, gas lines, etc.;

h. Sink holes located within 1,600 feet downslope of the proposed discharge point;

i. Other topographical features such as wetlands, lakes, ponds, rivers, streams, drainage ways, and swales, within 200 feet upslope and 600 feet downslope of the proposed discharge point;

j. Slope and side slope of any proposed dry ditch channels;

k. Public water supply intakes; and

l. Swimming or recreational water use areas within one mile upstream or five miles downstream of the proposed discharge point shown on a United States Geological Survey 7.5 minute topographic map or surveyed plat.

The site sketch should be to scale and accompanied by a United States Geological Survey 7.5 minute topographic map to provide information relevant to offsite setbacks;

5. Copies of all easements required by subdivision 2 of 12VAC5-640-450; however, at the discretion of the department, the submission of easements may be postponed until submission of the construction plan if the property owner submits the name, address, and property location of each person that must grant an easement to the owner;

6. If the discharge is to a wetlands, the application must contain a wetland delineation map of the geographic area for wetlands, stream, and open water on site and any other correspondence, approval, or certifications from the U.S. Army Corps of Engineers or the Department of Environmental Quality that wetlands were properly identified and delineated;

7. A letter of denial from the department or a certified site and soil evaluation report from a qualified person showing that the requirements of 12VAC5-640-30 D have been satisfied; and

8. Other information that the department deems necessary to comply with the intent of this chapter.

D. Upon receipt of a completed Combined Application the department will conduct a site review to determine if the site meets the minimum criteria contained in Part III (12VAC5-640-390 et seq.) of this chapter. The owner may opt to have a licensed professional engineer conduct the site review and submit appropriate documentation with the application for review by the department. The department may opt to conduct a site review to verify an application submitted by a licensed professional engineer. Upon conducting the site evaluation or upon reviewing the site evaluation conducted by a licensed professional engineer, the department will advise the owner in writing of the results of the evaluation.

1. When a satisfactory site is found for a discharging system, the written notice to the applicant shall include the type of discharge point found (i.e., wetland, all weather stream, intermittent stream, or dry ditch). The completed Combined Application and a copy of the documentation pursuant to 12VAC5-640-30 D shall be forwarded to the Department of Environmental Quality to complete the application process for a General Permit.

2. When no satisfactory discharge point site is found the department shall deny the application in accordance with 12VAC5-640-270. The department shall send a copy of the denial to the Department of Environmental Quality.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 2.13, eff. July 30, 1992; amended, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-240 Application for a construction permit

A. After a satisfactory site for a discharging system has been found and a General Permit has been obtained from the Department of Environmental Quality, the applicant shall submit an application, the appropriate fee, construction plans, specifications, design criteria and calculations, and documentation that coverage under the General Permit has been obtained. The documentation shall include the cover letter and copy of the General Permit issued by the Department of Environmental Quality. If the discharge is to a wetland, the construction submittal must include documentation that a Virginia Water Protection Permit from the Department of Environmental Quality or a permit under the U.S. Army Corps of Engineers has been obtained as needed. The purpose of the construction submittal is to demonstrate how the effluent limitations established by the SWCB and the construction, location, and performance requirements of this chapter can be met.

B. All plans for alternative discharging systems shall bear a suitable title showing the name of the owner and shall show the scale in feet, a graphical scale, the north point, date, revision dates (when applicable), and the name of the licensed professional engineer by or under whom prepared. The cover sheet and each plan sheet shall bear the same general title identifying the overall sewage disposal project and each shall be numbered. Appropriate subtitles shall be included on the individual sheets.

The plans shall be clear and legible. Plans shall be drawn to a scale that permits all necessary information to be plainly shown. The size of the plans shall be no larger than 30 inches by 48 inches. Data used should be indicated. The precise location of the proposed system shall be shown on the plans. Detailed plans shall consist of plan views, elevations, sections, and supplementary views that together with the specifications and general layouts provide the working information for the contract and construction of the work, including dimensions and relative elevations of structures, the location and outline form of equipment and components to be installed, the location and size of piping, water levels, ground elevations, and erosion control abatement facilities.

C. Complete technical specifications for the construction of the alternative discharging system and all appurtenances shall accompany the plans. The specifications accompanying construction drawings shall include, but not be limited to, all construction information not shown on the drawings, necessary to provide the installer with all detail of the design requirements as to the quality of material workmanship and fabrication of the project; type, size, strength, operating characteristics, and rating of equipment; allowable infiltration, machinery, valves, piping, and jointing of pipe; electrical apparatus, wiring, and meters; operating tools and construction materials; special filter materials such as stone, sand, gravel, or slag; miscellaneous appurtenances; chemicals when used; instructions for testing materials and equipment deemed necessary to meet design standards; and operational testing for the complete works and component units.

D. At a minimum, the construction submittal must show the following:

1. Information gathered in the site review evaluation;

2. For each system component, the plan shall note the type of component and, where applicable, the manufacturer, model number, approval, status in accordance with 12VAC5-640-432, hydraulic capacity, and treatment capacity;

3. The specific location of the property including the county tax map number (where available), a copy of the United States Geological Survey 7.5 minute topographic map showing the discharge point and downstream for one mile, and directions to the property;

4. The elevation of the house sewer line where it exits the house and the elevation of the inlet and outlet ports or tees on all treatment units. Where discharges are to dry ditches or intermittent streams the site plan shall show the elevation of the discharge point, the point 500' downgrade from the discharge point and points every 50 feet between the discharge point and 500' downstream. This requirement may be met by drawing a flow diagram showing all elements listed in this section;

5. The distance between all elevation points required by 12VAC5-640-240 D 4 so that the grade and setback distances can be established;

6. If a pump is proposed, specifications must be provided that include the manufacturer, model number, and a pump curve with a system curve overlain on the pump curve;

7. The location of the 100-year flood plain. All portions of a discharging system, except for the discharge pipe and step type post aeration, if required, shall be located above the 100-year flood plain;

8. Compliance with 12VAC5-640-430 through 12VAC5-640-470; and

9. Other information as deemed appropriate by the department to verify the design.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 2.14, eff. July 30, 1992; amended, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-250 Issuance of the construction permit

A construction permit shall be issued to the owner by the commissioner or the department after receipt and review of a complete application submitted under 12VAC5-640-240, a satisfactory site and construction plan review, and verification of issuance of a General Permit from the Department of Environmental Quality. The construction permit shall note whether the permitted system has general approval or is not in accordance with 12VAC5-640-432.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 2.15, eff. July 30, 1992; amended, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-260 Exception for failing onsite sewage disposal systems

When a failing onsite sewage disposal system is identified and the site location criteria in 12VAC5-640-400, 12VAC5-640-410, 12VAC5-640-420, and 12VAC5-640-470 H, and the dimensions of the easement specified in subdivision 2 of 12VAC5-640-450 cannot be met, the department may issue a written waiver that specifies the criteria that are being waived and the rationale for the waiver. In order to obtain this waiver, the owner must provide a written request for the waiver that includes justification and specifies any mitigating measures used to offset the reduced site conditions. The following conditions must apply in order for the waiver to be considered:

1. The issuance of a discharging system permit will reduce an existing health hazard or will improve or negate environmental impacts associated with the existing discharge. This determination shall be made by the department.

2. There will be no increase in the waste load generated by any additions to the dwelling except when necessary to provide for minimum facilities necessary for good sanitation. The minimum facilities for a single family dwelling are: a water closet, a bathroom sink, a bathtub or shower or both, and a kitchen sink. More than one bathroom may be added to a dwelling provided the potential occupancy of the structure is not increased.

3. Where a failing onsite sewage disposal system already has more than the minimum facilities described in subdivision 2 of this section, the discharging system may be designed and permitted to accommodate the entire existing sewage flow. In no event shall the system designed and permitted exceed the existing sewage flow unless all conditions and criteria of this chapter are met.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 2.16, eff. July 30, 1992; amended, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-262 Statements required upon completion of construction

A. Upon completion of the construction, alteration, or rehabilitation of a discharging system, the owner or agent shall submit to the department a completion statement signed by the contractor responsible for the construction and a completion statement signed by the licensed professional engineer responsible for the design, upon forms approved by the department, that the system was installed and constructed in accordance with the construction permit and complies with all applicable state and local regulations, ordinances, and laws. These completion statements shall be based upon inspections of the treatment works during and after construction or modification that are adequate to ensure the truth of the statements. Should the treatment works be modified from the approved construction plan, the licensed professional engineer shall submit "as built" drawings documenting the changes. The licensed professional engineer's completion statement shall certify that the treatment works as modified will comply with all applicable state and local regulations, ordinances, and laws.

B. No discharging system shall be placed in operation, except for the purposes of testing the mechanical soundness of the system, until an operation permit is issued by the department in accordance with 12VAC5-640-266.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia. of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-264 Operation and maintenance manual

A. Prior to issuance of the operation permit, the owner shall submit an operation and maintenance (O&M) manual for the discharging system. The general purpose of the manual is to present both technical guidance and regulatory requirements to facilitate operation and maintenance of the discharging system for both normal conditions and generally anticipated adverse conditions. The manual shall be designed as a reference document, being as brief as possible while presenting the information in a readily accessible manner. The manual shall be tailored to the specific system. The manual must state the minimum required frequencies for routine maintenance, operation, sampling, and monitoring frequencies in this chapter, but additional maintenance visits, sampling, and monitoring may be added as needed, depending on the design of the system. The manual should reflect the minimum operation and maintenance activities required to properly maintain the system and ensure compliance with the General Permit requirements.

B. The manual shall include the following minimum items:

1. Basic information relevant to the discharging system design including treatment unit capacities, pump operating conditions, a list of the components comprising the discharging system, a dimensioned site drawing, sampling locations, and contact information for replacement parts and chemicals for each unit process;

2. Safety considerations;

3. A list of all control functions and how to use them;

4. All operation, maintenance, sampling, and inspection schedules for the discharging system including any requirements that exceed the minimum requirements of this chapter;

5. The General Permit effluent sampling and reporting schedule;

6. The sampling location for each of the required General Permit parameters and for informal (process control) testing parameters;

7. The expected ranges of any recommended informal (process control) tests;

8. The limits of the discharging system and how to operate the system within those design limits; and

9. Other information deemed necessary or appropriate by the designer.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-266 Issuance of the operation permit

A. Prior to issuance of the operation permit, the department may inspect the discharging system to determine if the installation is in substantial compliance with the construction permit and the requirements of this chapter. Minor deviations from the permit or proposed plans and specifications, excluding the manufacturer's design and installation specification, that do not affect the quality of the sewage treatment process or endanger public health or the environment may be approved by the department.

B. Before receipt of an operation permit, the owner shall:

1. Submit the completion statements and "as built" drawings as required under 12VAC5-640-262; and

2. Submit the operation and maintenance manual as required under 12VAC5-640-264.

C. Upon the owner's satisfactory completion of the requirements in subsection B of this section, the commissioner or department shall issue an operation permit to the owner. The issuance of an operation permit does not denote or imply any warranty or guarantee by the commissioner or department that the discharging system will function for any specified period of time. The operation permit shall note whether the permitted system has general or nongeneral approval.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-270 Denial of a construction or operation permit

A. If the commissioner or department determines that the proposed site does not comply with this chapter or that the design of the system would preclude the safe and proper operation of a discharging system, the installation and operation of the system would create an actual or potential health hazard, or the proposed design would adversely impact the environment, the permit shall be denied and the owner shall be notified in writing, by certified mail, of the basis for the denial, and a copy shall be sent to the Department of Environmental Quality.

B. In addition to the grounds set forth in subsection A of this section, the operation permit shall be denied if the discharging system is not constructed in accordance with the construction permit or the owner has failed to provide the completion statements required by 12VAC5-640-262 or the operation and maintenance manual required by 12VAC5-640-264. The owner shall be notified in writing, by certified mail, of the basis for the denial, and a copy of the denial shall be sent to the Department of Environmental Quality.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 2.17, eff. July 30, 1992; amended, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-280 Revocation of construction permits and operation permits

After providing the owner with the notice and the opportunity to participate in an informal conference or consultation proceeding in accordance with § 2.2-4019 of the Code of Virginia and 12VAC5-640-180, the commissioner may revoke a construction permit or operation permit for any of the following reasons:

1. Failure to comply with the conditions of the permit including, but not limited to, the monitoring and maintenance requirements in Article 4 (12VAC5-640-490 et seq.) of Part III of this chapter and the payment of the inspection fee;

2. Violation of any requirement of this chapter for which no variance has been issued;

3. Facts become known which reveal that an actual or potential health hazard has been or would be created or that the environmental resources may be adversely affected by allowing the proposed discharging system to be installed or operated; or

4. Failure to comply with the effluent limitations set forth by the SWCB in the General Permit as determined by the monitoring required by Article 4 of Part III.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 2.18, eff. July 30, 1992; amended, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-290 Voidance of construction or operation permits

After providing the owner with the notice and the opportunity to participate in an informal conference or consultation proceeding in accordance with § 2.2-4019 of the Code of Virginia and 12VAC5-640-180, the commissioner or the department may declare a discharging system's construction or operation permit null and void when any of the following conditions occur:

1. Conditions such as house location, well location, discharging system location, discharge point, discharge system design, topography, drainage ways, or other site conditions are changed from those shown on the application or site plan;

2. Conditions are changed from those shown on the construction permit;

3. More than 60 months elapse from the date the permit was issued; or

4. The revocation or expiration of the General Permit or of the owner's approved registration by the SWCB.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 2.19, eff. July 30, 1992; amended, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-300 (Repealed.)

History

• Historical Notes: Derived from VR355-34-400 § 2.20, eff. July 30, 1992; repealed, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-310 (Repealed.)

History

• Historical Notes: Derived from VR355-34-400 § 2.21, eff. July 30, 1992; repealed, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-320 (Repealed.)

History

• Historical Notes: Derived from VR355-34-400 § 2.22, eff. July 30, 1992; repealed, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-330 (Repealed.)

History

• Historical Notes: Derived from VR355-34-400 § 2.23, eff. July 30, 1992; repealed, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-340 (Repealed.)

History

• Historical Notes: Derived from VR355-34-400 § 2.24, eff. July 30, 1992; repealed, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-350 (Repealed.)

History

• Historical Notes: Derived from VR355-34-400 § 2.25, eff. July 30, 1992; repealed, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-360 (Repealed.)

History

• Historical Notes: Derived from VR355-34-400 § 2.26, eff. July 30, 1992; repealed, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-370 (Repealed.)

History

• Historical Notes: Derived from VR355-34-400 § 2.27, eff. July 30, 1992; repealed, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-380 (Repealed.)

Historical Notes

Derived from VR355-34-400 § 2.28, eff. July 30, 1992; repealed, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

Part III Location, Design, Construction, Operation and Maintenance Criteria Article 1 Site Requirements

12VAC5-640-390 General

All discharging systems shall be located so that the treatment system, the point of discharge, all appurtenances, and the effluent leaving the system are sited in a manner that protects public health and minimizes environmental impacts.

History

• Statutory Authority: §§ 32.1-12, 32.1-163 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 3.1, eff. July 30, 1992.

12VAC5-640-400 Classifications of discharge points

The nature of the discharge point will determine what precautions must be taken to protect public health and environmental resources.

1. Where an all weather stream is available, it shall be used rather than discharging to an intermittent stream, dry ditch, or wetland. An all weather stream can readily dilute the effluent at least 10:1 at the seven consecutive day average of a 10-year low flow (7-Q-10) and thereby minimize public health and water quality impacts.

2. An all weather stream is represented by a solid blue line on the most recently published 7.5 minute United States Geologic Survey topographic map and has a 7-Q-10 flow that can provide 10:1 dilution of the effluent. Intermittent streams are represented by a dotted and dashed blue line on the most recently published 7.5 minute United States Geologic Survey topographic map. An all weather stream that provides less than 10:1 dilution of the effluent based on 7-Q-10 flow shall be considered an intermittent stream. Intermittent streams and dry ditches have an assigned stream flow 7-Q-10 of zero.

3. An owner may submit to the division additional hydrologic data, including but not limited to stream records and anecdotal evidence of long time residents, to support that a stream can provide a dilution ratio of 10:1. When in the opinion of the division, the evidence warrants a change, the division may determine that a stream is an all weather stream for the purposes of this chapter. The owner may also request site specific stream flow determinations from the Department of Environmental Quality.

4. Discharges into intermittent streams or dry ditches that do not have the dilution capability cited in subdivision 1 of this section shall be located entirely within the owner's property, or within a recorded easement as described in subdivision 2 of 12VAC5-640-450.

a. The average slope for any intermittent stream or dry ditch discharge receiving effluent from a discharging system shall be a minimum of 2.0% for the first 500 feet from the point of discharge. The intermittent stream or dry ditch shall be protected from erosion by the discharge as needed.

b. In order to prevent ponding, the minimum slope shall not be less than 1.0% at any point.

c. All slope measurements described in subdivisions 1 and 2 of this section shall be made prior to initiating any grading and are intended to reflect naturally occurring swales and drainage ways. Nothing contained herein however, is intended to prohibit a property owner from making minor grading improvements to prevent ponding in areas with minimal slopes. Naturally occurring swales and drainage ways may be extended with an engineered channel on a case-by-case basis, but any engineered channel must tie into the existing natural swale or drainage.

5. Wetlands shall be confirmed by the U.S. Army Corps of Engineers or the Department of Environmental Quality, as appropriate, based on the type of wetland. Confirmation of delineated wetlands shall be provided and include a wetland delineation map, wetland field data sheets, and any other documentation from the U.S. Army Corps of Engineers or the Department of Environmental Quality indicating their approval of the wetland boundary. 7-Q-10 flows cannot be calculated for wetlands and therefore the assigned 7-Q-10 flow value is zero. Discharges to wetlands shall be located entirely within the owner's property, or within a recorded easement as described in subdivision 2 of 12VAC5-640-450.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 3.2, eff. July 30, 1992; amended, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-410 Subdivisions

Discharging systems may be permitted in existing subdivisions in accordance with this chapter.

No discharging system shall be permitted in any subdivision created after July 30, 1992, when a central sewer system is available or may be permitted to serve the subdivision. If the SWCB determines that no central sewage facilities are reasonably available or may be permitted, and each proposed site is eligible for registration under the General Permit, then the locality, in which the proposed subdivision is located, may request that the department review the plan for compliance with this chapter. When subdivisions are proposed utilizing individual discharging systems and dry ditch discharges, the use of easements shall be prohibited for multiple systems discharging to a single dry ditch or intermittent stream unless the owner(s) take necessary action to prevent access by children, animals, or other vectors.

History

• Statutory Authority: §§ 32.1-12, 32.1-163 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 3.3, eff. July 30, 1992.

12VAC5-640-420 Setback distances from discharge points and downstream channels for the protection of public health

A. Discharges proposed within one mile (upstream or up channel) of any public water intake shall not be permitted.

B. Discharges proposed within one mile upstream or up channel of any area explicitly designated for public swimming shall not be permitted.

C. When any river, stream, or other potential discharge area appears to receive significant primary contact use, such as, but not limited to, swimming, water skiing, tubing, or wet-wading, so that the discharge will pose a significant threat to public health, the district health director may require a higher level of treatment and reliability class for the permitted discharge facility.

D. The district health director, in consultation with the local governing authority and the department, may prohibit discharges into specified portions of the river, stream, or other potential discharge area. Prior to taking such action, the health director shall take the following steps:

1. Publish a notice announcing the department's intention to consider areas for restricting the use of discharging systems, establishing the date, time and location or locations of the public meeting or meetings, and soliciting public comment on the proposed area or areas being reviewed;

2. Request the opinion of the local governing body and other appropriate government agencies concerning proposed restrictions to be submitted before the close of the public comment period;

3. Have a public comment period on the proposal of not less than 30 days;

4. Hold at least one public meeting, 30 days or more after publication of the notice specified in subdivision 1 of this subsection; and

5. Evaluate the public comments received and staff evaluations regarding the use of the proposed area or areas for primary contact uses.

When in the best professional opinion of the health director the area or areas under consideration receives, for 30 days or more per year, significant primary contact uses, such that the discharge will pose a significant threat to public health, the director may designate areas where discharge systems are prohibited. Prohibited discharge areas may include areas upstream in the main channel and tributaries, from the area under review, for distances up to one mile if warranted by the evidence. Prohibited discharge areas shall be clearly defined in writing and delineated on a United States Geological Survey 7.5 minute topographic map. The prohibition on discharges, if any are found necessary, shall be effective upon notice after completion of the elements contained in this section.

E. The wastewater treatment system (tankage and components), shall be a minimum of 50 feet from private and public water wells and private cisterns. The discharge point and the channel of treated effluent flow shall be located in accordance with the distances given in Table 3.1 from private and public water wells and cisterns. Where the bottom elevation of a cistern is located above the elevation of the discharge point, the setback distances shall not apply. The setback distances between the water well or cistern and the downstream channel established in Table 3.1 shall apply for 50 feet downstream of the discharge point for all weather streams and 500 feet downstream for intermittent stream or dry ditch discharges. For wetlands where the flow path can be established, generally where the slope is 10% or greater, the setback distances between the water well or the cistern and the "downstream channel" shall apply for 250 feet downstream of the discharge point. For wetlands where the flow path cannot be established, generally where the slope is less than 10%, then the distance shall be measured radially for 250 feet from the point of discharge.

F. Setback distances to other wells not covered in Table 3.1 of this section, such as geothermal and gas wells, will be determined on a case-by-case basis.

G. No discharging system or any portion of the channel carrying the treated effluent flow shall be within 100 feet of a spring. Further, no discharging system shall discharge within 1,500 feet upstream or 100 feet downstream of any spring used for human consumption.

H. Discharging systems are prohibited from discharging directly into sink holes or into dry ditches, intermittent streams, wetlands, streams, or other waterways that flow into sink holes within 1,500 feet from the point of discharge.

I. Dry ditch discharges shall not have limestone outcrops within the dry ditch channel. This provision shall apply for a distance of 50 feet along the channel.

J. Except as noted below, the department will not approve discharging systems except where discharge points will be at least 500 feet apart. The separation distance may be reduced to 250 feet between discharge points in accordance with the following:

1. For discharges to an all weather stream, the distance may be reduced to 250 feet by providing a Reliability Class II facility.

2. For discharges to a dry ditch or intermittent stream, the distance may be reduced to 250 feet by providing a Reliability Class I system that produces a TL-3 effluent and a fecal coliform concentration of 100 col/100 ml or less.

3. No reduction in the distance between discharge points is allowed for discharges to wetlands.

K. No discharge shall be permitted under this chapter which will result in the condemnation of shellfish waters or the continued condemnation of shellfish waters closed only because of inadequate water quality.

| TABLE 3.1 SETBACK DISTANCES FROM PRIVATE AND PUBLIC WATER WELLS AND CISTERNS (All distances are in feet) | | | | | --- | --- | --- | --- | | Type of Water Supply | Distance from Point of Discharge | Distance from Downstream Channel | | | Discharge to All Weather Stream | Discharge to Wetland², Intermittent Stream, or Dry Ditch | | | | Class I¹ Well | 100 | 100 | 100 | | Class II¹ Well | 100 | 100 | 100 | | Class IIIA Well | 50 | 50 | 50 | | Class IIIB Well | 50 | 50 | 50 | | Class IIIC Well | 100 | 50 | 100 | | Class IV Well | 100 | 50 | 100 | | Cistern | 100 | 50 | 100 | | ¹Class I and II well specifications are found in the Waterworks Regulations (12VAC5-590). All other well specifications may be found in the Private Well Regulations (12VAC5-630). ²The downstream "channel" of a wetland where the flow path can be established shall be a minimum of 25 feet wide and approximately centered on the flow path. Where the flow path cannot be established in a wetland, then the distance shall be measured radially from the point of discharge. | | | |

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 3.4, eff. July 30, 1992; amended, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

Article 2 Design Requirements

12VAC5-640-430 Performance requirements

Article 2 Design Requirements

A. All systems operated under this chapter shall meet the effluent limitations set forth by the State Water Control Board in the General Permit. All systems operated under this chapter shall maintain the treatment system in accordance with the approved construction permit or as modified by the final construction permit in accordance with the operation permit, "as built" plans, and the operation and maintenance manual.

B. No system shall be approved for use which provides a bypass pipe, or otherwise allows untreated or partially treated effluent to discharge in the event of a system failure.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 3.5, eff. July 30, 1992; amended, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-432 Treatment unit and additional system component classifications

A. Biological treatment units will be classified by the division according to the data available to demonstrate the performance limits and reliability of those treatment units. The division may classify treatment units as generally approved or not generally approved. The type and frequency of testing for each approval class is designed to reflect the certainty with which the system has demonstrated its ability to meet the limits of the General Permit or the performance requirements of this chapter.

1. General approval may be issued by the division for both TL-2 and TL-3 treatment units in accordance with the current policies of the division. Generally approved units shall be listed on the division's website.

2. Nongenerally approved biological treatment unit designs shall be properly supported with design calculations and one or more of the following:

a. Documentation from applicable engineering standards, texts, or other publications;

b. Relevant peer-reviewed research;

c. Technical guidance from other states (may be considered on a case-by-case basis); or

d. Technical guidance from the U.S. Environmental Protection Agency.

Scale drawings of the treatment unit, appropriate design calculations, and control system details shall be provided that demonstrate the ability of the unit to meet the required effluent limits and reliability standards at the proposed design flow.

B. Additional system components for discharging systems will be classified by the division as generally approved or not generally approved.

1. The division shall consider additional system components such as post-filtration, disinfection, dechlorination, and post-aeration to be generally approved if the unit has been tested and approved under a National Sanitation Foundation (NSF) or other recognized protocol for the proposed wastewater use or if the design complies with the design standards in 12VAC5-640-460.

2. Nongenerally approved system component designs shall be properly supported with design calculations and one or more of the following:

a. Documentation from applicable engineering standards, texts, or other publications;

b. Relevant peer-reviewed research;

c. Technical guidance from other states (may be considered on a case-by-case basis); or

d. Technical guidance from the U.S. Environmental Protection Agency.

Scale drawings of the treatment unit, appropriate design calculations, and control system details shall be provided that demonstrate the ability of the unit to meet the required effluent limits and reliability standards at the proposed design flow.

C. Discharging systems that are comprised entirely of generally approved biological treatment units and system components as described in this section are considered generally approved treatment systems.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-434 Reliability

A. Reliability is a measure of the ability of a component or system to perform its designated function without failure or interruption of service. Overflow criteria, such as the allowable period of noncompliant discharge, are utilized solely for the establishment of reliability classification for design purposes and are not to be construed as authorization for, or defense of, an unpermitted discharge to state waters. The reliability classification shall be based on the water quality and public health and welfare consequences of a component or system failure.

B. Reliability Class I is required for dry ditch and intermittent stream discharges with 250 feet of easement available and wetland discharges with 100 feet of easement available.

1. For biological treatment processes, Reliability Class I shall be met by providing one of the following:

a. A passive, backup biological treatment system (e.g., an intermittent sand, peat, or media filter or a constructed wetlands);

b. A generator for the treatment system with automatic transfer switch;

c. A 24-hour holding tank for raw wastewater with telemetry system to immediately notify the operator of system failure; or

d. Any alternative means that limits the discharge of a noncompliant effluent to a maximum of 24 hours.

2. For disinfection, a Reliability Class I design shall ensure that the effluent is continually disinfected by providing electronic or mechanical means of monitoring the process such that failure of disinfection systems may be corrected within 24 hours.

C. Reliability Class II is required for dry ditch and intermittent stream discharges with 500 feet of easement available and wetland discharges with 250 feet of easement available. Reliability Class II is also required for the reduction of the distance between discharge points to 250 feet on an all weather stream.

1. For biological treatment processes, Reliability Class II shall be met by providing:

a. A fixed film biological treatment process such as an intermittent sand filter, recirculating media filter, or a peat filter;

b. A suspended growth biological system followed by post-filtration;

c. Telemetry to relay alarm conditions to the operator; or

d. Any alternative means that limits the discharge of a noncompliant effluent to a maximum of 36 hours.

2. For disinfection, a Reliability Class II design shall ensure that the effluent is continually disinfected by providing electronic or mechanical means of monitoring the process such that failure of disinfection systems may be corrected within 36 hours.

D. Reliability Class III is required for all weather stream discharges with a separation distance between discharge points of 500 feet or greater. For the purposes of this chapter, noncompliant discharges must be limited to a maximum of 48 hours.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-440 Special factors affecting system design

Each type of discharging system has its own unique advantages and disadvantages. These unique characteristics define the situations where a system may be used to advantage. The design of the system must be appropriate for the intended use and the site conditions where the system is to be installed. Subdivisions 1 through 6 of this section contain a list of factors that will require special design consideration. This list should not be considered all encompassing. There may be other design factors that require special consideration. A preliminary engineering conference may be scheduled with the department to discuss such factors prior to submitting designs for department review.

1. When a discharge is proposed to a wetland, dry ditch, or intermittent stream, restricted access to the wetland, dry ditch, or intermittent stream in accordance with 12VAC5-640-450 to protect public health.

2. Intermittent use for the purposes of this chapter constitutes use of the system for less than three consecutive months. Systems serving weekend cottages or other intermittent uses require special design, operation, and maintenance consideration.

3. When a discharging system is proposed to be located in an area subject to infiltration by surface water or shallow groundwater, the department may require additional protection from infiltration, inflow, and flotation, including placement of the system above natural grade.

4. Erosion must be controlled by the owner of the discharging system in accordance with any local erosion control ordinances.

5. All systems shall normally be designed to treat the BOD₅ loading rate of 0.4 lbs/day per bedroom and a flow of 150 gallons per day per bedroom for systems up to three bedrooms. Systems serving single family dwellings having more than three bedrooms shall be permitted and designed to treat the anticipated loading rate based on BOD₅ and be capable of handling anticipated peak loading and flow rates. All systems shall be designed to operate over the range of anticipated flow and loading rates. When a system is permitted with a design less than the maximum capacity of the dwelling, the owner shall have the construction permit recorded and indexed in the grantor index under the owner's name in the land records of the clerk of the circuit court having jurisdiction over the site of the discharging system.

6. All system designs must include protection of the components from freezing or other adverse weather conditions and ensure that the system will function properly year round.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 3.6, eff. July 30, 1992; amended, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-450 Design criteria for the use of intermittent streams, dry ditches, or wetlands

All owners of systems discharging to an intermittent stream, dry ditch, or wetland shall ensure the following conditions are met:

1. Direct contact between minimally diluted effluent and insects, animals, and humans must be restricted for the life of the system. This will be achieved by reducing the chance of ponding and run-off and limiting access to the effluent. The department shall require fencing, rip-rap, or other barriers to restrict access to effluent discharging to a dry ditch, intermittent stream, or wetland as deemed necessary to protect public health. This determination shall be made by the department on a case-by-case basis.

a. For dry ditch and intermittent stream discharges, the restricted access area shall begin at the point where the effluent is discharged and continue for 500 feet, until the effluent discharges into an all weather stream or is no longer visible during the wet season. The design shall provide justification for the length of the restricted access channel if less than 500 feet.

b. For wetland discharges, the restricted access shall extend for a distance of 250 feet along the flow path of the discharge unless a 10:1 dilution with the wetland can be achieved. If the flow path cannot be established and a 10:1 dilution cannot be obtained, then access shall be restricted for 100 feet radially from the point of discharge. For wetland discharges, the access barrier may be a subsurface discharge point, but in no case shall the discharge point and diffuser be greater than 18 inches below the natural wetland surface.

2. When effluent is discharged to a dry ditch, intermittent stream, or wetland, the owner shall own the land or acquire an easement from the downstream or downgradient land owner to discharge on all land below the point of discharge for the distance shown in Table 3.2. To allow for system construction and repair within the restricted access area, and to facilitate maintenance and monitoring, the easement shall be a minimum of 25 feet wide and approximately centered on the low point of the dry ditch or intermittent stream for the entire length of the restricted access area. For wetlands, the easement shall be measured radially from the point of discharge unless flow direction can be established. In those cases where flow direction can be established, the easement shall be a minimum of 25 feet wide and approximately centered on the discharge path and extend for a distance along the flow path as described in Table 3.2. If the slope across the discharge site is equal to or greater than 10%, the flow direction can be determined by observation. For slopes less than 10%, a site specific study must be conducted to document the direction of flow. All easements must be in perpetuity and shall be recorded by the owner with the clerk of the circuit court having jurisdiction over the property prior to issuance of the construction permit. For the purposes of complying with this chapter, written approval to utilize an easement owned by the Virginia Department of Transportation shall be recorded by the owner with the clerk of the circuit court office having jurisdiction over the property.

3. Each discharging system that discharges to a dry ditch, intermittent stream, or wetland must receive additional treatment beyond that required by the General Permit in order to reduce the increased potential for public health problems which may result when partially treated effluent is not diluted. Such additional treatment shall be capable of producing an effluent with a quality of 10 mg/l of BOD₅, 10 mg/l of suspended solids and a fecal coliform level of less than or equal to 100 colonies per 100 ml. Treatment units approved as TL-3 are recognized as having the ability to meet this BOD₅ and TSS standard, but have not been tested for compliance with the fecal coliform standard. Therefore, the following reliability classifications in Table 3.2 must be met when designing discharge systems intended to discharge into dry ditches, intermittent streams, or wetlands.

| TABLE 3.2 REQUIREMENTS FOR RELIABILITY CLASSIFICATION AND OWNERSHIP OR EASEMENTS DOWNSTREAM FROM SYSTEMS THAT DISCHARGE TO DRY DITCHES, INTERMITTENT STREAMS, OR WETLANDS | | | | | --- | --- | --- | --- | | Reliability Class | Downstream or Down Channel Distance for Dry Ditches or Intermittent Streams (feet) | Wetlands from Discharge Point along Flow Path or Radially from Discharge Point | | | No spring below | Spring below | | | | Reliability Class I | 250 ft | 1,500 ft | 100 ft | | Reliability Class II | 500 ft | 1,500 ft | 250 ft |

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 3.7, eff. July 30, 1992; amended, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-460 Design requirements for system components

A. All discharging systems shall be equipped with a means of disinfecting the effluent which is acceptable to the division and meets the performance requirements of this chapter.

1. All discharging systems utilizing chlorine as a disinfectant shall be equipped with a chlorinator and contact chamber. Dechlorination is to be supplied if required by the General Permit.

a. Chlorinator capacity shall be based on the degree of treatment, flow variations, and other variables in the treatment processes. For disinfection, the capacity shall be adequate to maintain a total chlorine residual between 1.0 mg/l and 3.0 mg/l in the effluent after the required contact period. All chlorinators shall be designed to provide the appropriate dose of chlorine and mix the chlorine with the effluent. All chlorine products used to disinfect effluent from a discharging system shall be approved by the U.S. Environmental Protection Agency for use as a sewage disinfectant; products unapproved for wastewater disinfection are not acceptable. Use of unapproved products shall constitute a violation of this chapter.

b. The chlorine contact chamber shall have a length to width ratio of 20:1 and shall provide a contact time of 30 minutes based on peak hourly flow, or 60 minutes based on peak daily flow. The length to width ratio may be reduced on a case-by-case basis when increased chlorine contact times are utilized.

c. When required by the General Permit, dechlorination capacity shall be adequate to dechlorinate the maximum chlorine residual anticipated and achieve the required General Permit effluent limits for total residual chlorine by providing at least 1-1/2 parts sulfite salt to one part chlorine. Provisions shall be made to thoroughly mix the dechlorinating agent with the contact tank effluent within a period of approximately one minute.

d. To meet Reliability Class I or Class II, all chlorination and dechlorination units shall be alarmed to notify the operator when tablets are not present in the dosing chamber or equipped with duplicate units that automatically switch over to the redundant unit if the primary unit is not operating.

2. Disinfection can be achieved through exposure of microorganisms to a sufficient level of ultraviolet light (UV) irradiation at the germicidal wavelength for an adequate period of time.

a. UV disinfection equipment shall be capable of providing a minimum average calculated dose of 50,000 microwatt-seconds per square centimeter after the UV lamps have been in operation for 7,500 hours or more and at a 65% transmissivity. The dosage may be reduced on a case-by-case basis when sufficient information is provided to demonstrate that the required level of disinfection can be obtained at a lower dose level through test data.

b. UV lamps shall produce 90% or more of their emitted light output at the germicidal wavelength of 253.7 nanometers.

c. UV lamp assemblies shall be so located as to provide convenient access for lamp maintenance and removal.

d. UV lamps should not be viewed in the ambient air without proper eye protection as required by VOSH and other applicable regulations. The system design should prevent exposure of bare skin to UV lamp emission for durations exceeding several minutes.

e. An elapsed time meter shall be provided to indicate the total operating time of the UV lamps.

f. UV systems are sensitive to color and suspended solids. Precautions should be taken to protect the UV system from both color and excessive suspended solids.

g. To meet Reliability Class I or Class II, all UV units shall be equipped with a sensor to detect bulb failure with an alarm or equipped with duplicate units that automatically switchover if the primary unit is not operating.

B. Post-aeration as required by the General Permit shall be provided to ensure that the final effluent complies with the dissolved oxygen effluent limits in the General Permit. Post-aeration may involve diffused aeration or cascade type aeration. All post-aeration designs shall assume a zero dissolved oxygen concentration in the influent wastewater to the post-aeration unit.

1. Effluent post-aeration may be achieved by the introduction of diffused air into the effluent.

a. Diffused aeration basins shall be designed to eliminate short-circuiting and the occurrence of dead spaces. For maximum efficiencies, sufficient detention time shall be provided to allow the air bubbles to rise to the surface of the wastewater prior to discharge from the basin.

b. When the detention time in the aeration basin exceeds 30 minutes, consideration shall be given to the oxygen requirements resulting from biological activity in the aeration unit.

c. Diffused air aeration systems shall be designed utilizing Fick's Law (the rate of molecular diffusion of a dissolved gas in a liquid) in the determination of oxygen requirements. Supporting experimental data shall be included with the submission of any proposal for the use of diffusers that are considered nonconventional. Such proposals will be evaluated on a case-by-case basis by the division.

d. Alternatively, an airflow of one cubic foot per minute at a diffuser submergence of one foot is sufficient to increase the dissolved oxygen of 1000 gallons per day of effluent to greater than five mg/l dissolved oxygen at 25°C.

e. If airflow is to be siphoned off the blower for the biological treatment unit, calculations shall be submitted to verify that there is sufficient air for both uses.

2. Effluent post-aeration may be achieved through a turbulent liquid-air interface established by passing the effluent downstream over either a series of constructed steps that produces a similar opportunity for transfer of dissolved oxygen to the effluent, otherwise known as cascade or step aeration.

a. The following equation shall be used in the design of cascade/step type aerators:

| | rⁿ = (C_s-C_a)/(C_s-C_b) | | | | --- | --- | --- | --- | | | where: r | = | Deficit ratio | | | C_s | = | Dissolved oxygen saturation (mg/l) | | | C_a | = | Dissolved oxygen concentration above the weir, assumed to be 0.0 mg/l | | | C_b | = | Dissolved oxygen concentration in the effluent from the last or preceding step | | | n | = | The number of equal size steps | | | r | = | 1 + (0.11) (ab) (1 + 0.046 T) (h) | | | where: T | = | Water temperature (°C) | | | h | = | Height of one step (ft) | | | a | = | 1.0 for effluents (BOD₅ of less than 15 mg/l) or 0.8 for effluents (BOD₅ of 15 mg/l to 30 mg/l) | | | b | = | 1.0 for free fall and 1.3 for step weirs |

b. The equation for determining the number of steps is dependent upon equidistant steps, and if unequal steps are used, transfer efficiencies must be determined for each separate step.

c. The effluent discharge to a cascade type aerator shall be over a sharp weir to provide for a thin sheet of wastewater. Consideration shall be given to prevention of freezing.

d. The final step of the cascade type aerator shall be above normal stream flow elevation and the cascade aerator shall be protected from erosion damage due to storm water drainage or flood/wave action.

e. When pumping is necessary prior to discharge over the cascade aerator, the range of the flow rate to the post-aeration unit must be accounted for in the design.

f. A step aerator with multiple steps each less than or equal to one foot and a total drop of five feet is sufficient to increase the dissolved oxygen in an effluent at 25°C to greater than five mg/l.

C. Post-filtration may be used to ensure compliance with the reliability standards in 12VAC5-640-434 and generally follow the biological treatment unit and are prior to disinfection in the treatment process. For granular media filters, the media depth shall not be less than 30 inches. Sand media for intermittently dosed and recirculated effluent, shall have an effective size of 0.30 mm to 1.0 mm and 0.8 mm to 1.5 mm, respectively. The uniformity coefficient should not exceed 4.0. No more than 2.0% shall be finer than 0.177 mm (80 mesh sieve) and not more than 1.0% shall be finer than 0.149 mm. No more than 2.0% shall be larger than 4.76 mm (4 mesh sieve). Larger granular media up to five mm in effective size may be considered on a case-by-case basis. The filter shall be equipped with an underdrain. The surface of the filter shall be accessible for maintenance. For the purposes of a filtration unit, the maximum surface hydraulic loading rate is 15 gpd/sf.

D. Constructed wetlands that are used as a passive backup biological treatment unit for the purposes of meeting Reliability Class I requirements of 12VAC5-640-434 B shall be lined with a minimum surface area of 100 square feet, a depth of 18 inches, a length to width ratio of about four to one, and shall have subsurface flow. Wastewater shall be disinfected prior to entering the constructed wetlands and sampling ports shall be provided to allow monitoring of the influent to the wetlands. Effluent dechlorination prior to entering the wetlands may be necessary to protect the plants from toxic levels of chlorine.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 3.8, eff. July 30, 1992; amended, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

Article 3 Construction Requirements

12VAC5-640-470 General construction requirements

Article 3 Construction Requirements

A. No portion of any system may be covered or used until inspected, corrections made if necessary, and approved, by the department or unless expressly authorized in writing by department. All applicable sections contained in the Sewage Handling and Disposal Regulations, 12VAC5-610, shall be used to establish design and construction criteria not contained in this chapter.

B. Gravity sewer lines and lines between components of the system shall be schedule 40 pipe and shall have a minimum grade of 1.25 inches per 10 feet for three-inch and four-inch sewer lines. Discharge lines after primary or secondary treatment units shall have a minimum grade of six inches per 100 feet. Where minimum grades cannot be maintained, detailed pump specifications shall be shown on the site plan in accordance with Article 4 (12VAC5-610-598 et seq.) of Part IV of the Sewage Handling and Disposal Regulations.

C. The treatment unit and all piping and appurtenances shall be located in conformance with the approved plans. All changes in location shall be approved by the local department prior to the installation of the system.

D. All pumps and appurtenances to the pump shall be installed according to the plans and specifications approved by the department and referenced in the permit.

E. All wiring shall be approved by the local building official and shall be weather tight and permanent in nature (hard wired).

F. The control panel for the system shall be located within 15 feet of the treatment unit and shall be provided with a manual override switch. Each pumping station shall be provided with controls for automatically starting and stopping the pumps based on water level. When float type controls are utilized they shall be placed so as to be unaffected by the flow entering the wet well.

G. All mechanical treatment units shall be provided with an alarm system on a separate electrical circuit from the remainder of the treatment unit. The alarm shall be both audio and visual and shall be located in an inhabited portion of the dwelling. Examples of alarm conditions to be monitored include aerator failure, blower failure, and high water level.

H. Except for the discharge pipe, and step type post aeration if used for post-aeration, no portion of the discharging system may be located in the 100-year flood plain.

I. The design must allow for sampling to confirm the efficacy of the treatment process. Sampling ports shall be identified on the construction documents and shall meet the following minimum requirements:

1. All discharging systems utilizing chlorine as a disinfectant shall be equipped with a four inch or larger sampling port connected to an approved effluent collection box at the chlorine contact chamber after the 30-minute or 60-minute contact time (i.e., the sampling port shall be located at the outlet end of the chamber).

2. A separate sampling port shall be required after the dechlorination unit.

3. The sampling location is to be identified and a port provided if needed for sampling the final effluent prior to the effluent entering the discharge channel.

4. Other sampling ports may be required on a case-by-case basis due to the system design.

J. All discharging systems shall have a clean out port, accessible from the surface of the ground within 10 feet of the influent invert of the treatment unit.

K. Positive ventilation shall be provided at pumping stations when personnel are required to enter the station for routine maintenance.

L. Sand filter liners shall be constructed of clay having a permeability of 10^-6 cm/sec. or less, a 28 mil vinyl or PVC plastic liner, concrete, or other material approved by the division. A watertight seal shall be provided where underdrain piping exits the filter.

M. The owner of each discharging system shall post a permanent sign at the point of discharge with the following notice:

This pipe carries treated sewage effluent and is not suitable for human consumption. This system is owned by (FULL NAME OF PERMIT HOLDER) and is maintained by (NAME AND PHONE NUMBER OF LICENSED OPERATOR WITH OVERSIGHT OF THE SYSTEM).

The sign shall be posted within three feet of the discharge pipe, shall be plainly visible to the public, and shall be constructed of durable material. All lettering shall be at least one-inch high and shall be clearly legible. The sign shall have black letters on a white background (or be painted in other contrasting colors) and be plainly visible at a distance of 25 feet to a person with normal vision. Failure to maintain this sign shall be grounds for suspending the owner's operation permit.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 3.9, eff. July 30, 1992; amended, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-480 (Repealed.)

History

• Historical Notes: Derived from VR355-34-400 § 3.10, eff. July 30, 1992; repealed, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

Article 4 Monitoring, Operation, and Maintenance Requirements

12VAC5-640-490 Monitoring

Article 4 Monitoring, Operation, and Maintenance Requirements

A. Discharging systems that discharge improperly treated effluent can endanger public health and threaten environmental resources. All discharging systems shall be routinely inspected and the effluent sampled to determine compliance with the effluent limitations set forth by the State Water Control Board in the General Permit and in accordance with 12VAC5-640-430 and 12VAC5-640-510. All testing requirements contained in this chapter are the responsibility of the system owner to have collected, analyzed, and reported to the department.

B. There are two types of testing recognized by this chapter: formal compliance testing and informal (process control) testing. Formal testing is conducted to determine either compliance or noncompliance with the General Permit. Informal testing is conducted to assess the treatment system's performance and to determine when additional formal compliance testing is necessary. Informal testing may support but shall not be the sole basis for revoking the approval of the system pursuant to 12VAC5-640-280.

C. All treatment systems shall undergo startup testing to assess the ability of the system to comply with the established performance requirements.

1. Treatment systems are considered generally approved for the purposes of establishing startup testing requirements only when all treatment components (i.e., biological treatment unit, disinfection, dechlorination, post-aeration, etc.) of the system are considered generally approved as described in 12VAC5-640-432.

2. All new discharging systems shall undergo formal startup compliance testing for parameters limited by the General Permit. The collection, storage, transportation, and analysis of all formal compliance samples shall be in accordance with the requirements of the General Permit.

a. For generally approved systems, the first formal compliance testing event shall occur 45 to 90 days after the system begins discharging. If the formal compliance test data indicate the system is in compliance with the General Permit, then the system will revert to annual formal compliance sampling in accordance with the General Permit. The initial sample may be used to comply with the first annual sampling requirement. If the testing data indicates that any parameter is out of compliance, subsection E of this section shall apply.

b. For nongenerally approved systems, the first formal compliance testing event shall occur 45 to 90 days after the system begins discharging. Three additional formal compliance testing events are to occur quarterly and at least 60 days apart. If the four startup compliance test data indicate the system is in compliance with the General Permit, then the system will revert to annual formal compliance sampling in accordance with the General Permit. If the testing data indicates that any parameter is out of compliance, subsection E of this section shall apply.

3. Informal (process control) testing shall be conducted monthly for at least six consecutive months beginning the second full month after the issuance of the operation permit. After successful startup of the treatment system, informal testing shall be conducted semiannually at a minimum and any time formal testing is conducted. Informal testing shall be in accordance with the approved operation and maintenance manual, which shall include at a minimum the tests listed in Table 3.3. The specific test, sample location, and frequency shall be itemized in the operation and maintenance manual for the treatment system.

D. Both formal and informal routine monitoring is required after a system successfully completes startup testing.

1. After a system successfully completes startup testing, the system formal testing reverts to the General Permit monitoring frequency for the parameters limited by the General Permit. The collection, storage, transportation, and analysis of all formal testing shall be in accordance with the requirements of the General Permit.

2. Informal (process control) testing shall be conducted during routine maintenance visits. The specific test, sample location, and frequency shall be itemized in the operation and maintenance manual for the treatment system. When an operation and maintenance manual is not available, informal testing shall be sufficient to assess the treatment system's performance. Table 3.3 contains the minimum informal testing that must be conducted as appropriate for a given system.

| TABLE 3.3 INFORMAL (PROCESS CONTROL) TESTING | | | --- | --- | | Treatment Unit | Informal Tests | | Septic tank/trash tank | Sludge depth | | Suspended growth biological treatment unit | Dissolved oxygen, settleabilty, pH, odor | | Fixed film biological treatment unit | Dissolved oxygen (effluent from unit), pH, odor | | Chlorine disinfection/dechlorination | TRC at end of contact tank (>1.0 mg/l), TRC after dechlorination | | Ultraviolet disinfection UV | Turbidity prior to UV | | Final effluent | Dissolved oxygen, pH, odor, color |

E. The department may require additional formal compliance testing or informal testing, or both, as necessary to protect public health and the environment. Additional testing shall be based on observed problems and shall not be implemented routinely on all discharging systems.

1. Anytime a discharging system is found to be out of compliance with the effluent limitations of the General Permit, follow-up formal compliance testing shall be repeated between 45 and 90 days after the original samples were collected and the results reported to the local health department. Prior to resampling, the operator should attempt to determine the reason for the noncompliance and take corrective actions.

2. Anytime an informal test reveals a potential problem, additional formal or informal testing may be conducted to review the effectiveness of any repairs or adjustments.

3. Anytime the results of two consecutive formal compliance tests as specified in subdivision C 2 or D 1 of this section result in a violation of the effluent limitations of the General Permit, informal testing shall revert to monthly frequency until satisfactory results are obtained for six consecutive months. Nothing in this section shall preclude requiring the collection of samples for formal compliance testing as described in subdivisions C 2 and D 1 of this section to determine compliance with the effluent limitations set forth in the General Permit.

F. The owner of each system is responsible for ensuring that the collection, analysis, and reporting of all effluent sample tests are completed in a timely fashion and in accordance with this section and 12VAC5-640-510. The department shall conduct an annual inspection and may conduct additional inspections at its discretion. Furthermore, the department may conduct or mandate formal or informal testing as deemed appropriate. If a system is in compliance three consecutive years, the department may reduce the department inspection frequency to a three-year cycle. Annual inspections by the department will resume if the department receives evidence that the system is out of compliance. Compliance for the purposes of this section is compliance with the testing, inspection, effluent limits, and reporting requirements of this chapter. Inspection by the department does not substitute for the required operation, maintenance, testing, and reporting requirements in 12VAC5-640-490, 12VAC5-640-500, and 12VAC5-640-510.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 3.11, eff. July 30, 1992; amended, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-500 Operation and maintenance requirements

A. Due to the potential for degrading surface water and groundwater quality or jeopardizing the public health, or both, routine operation and maintenance of discharging systems is required. In order to assure the treatment system is operated, maintained, monitored, and reported properly, the permit holder shall engage a licensed operator as defined in subsection E of this section. Reporting in accordance with 12VAC5-640-490 and 12VAC5-640-510 is sufficient evidence of an ongoing contract. Owners with existing monitoring waivers that allow the owner to collect formal compliance samples as of December 16, 2015, may be extended, but no new waivers shall be issued. In the event the individual fails to collect three or more of any of the required samples in any five-year period, the department will void the waiver and require evidence of an operation and maintenance contract that includes monitoring.

B. It is the owner's responsibility to do the following:

1. Have the system operated and maintained by a licensed operator;

2. Have an operator visit the system at the frequency required by this chapter (at least semiannually);

3. Have an operator collect and analyze any samples required by this chapter;

4. Provide prompt maintenance and repair of the treatment works. If an owner is notified by the operator of a repair or maintenance need pursuant to subdivision C 4 of this section and the discharge does not comply with the effluent requirements of the General Permit, then the owner shall begin pump and haul of the sewage and take other actions as may be directed by the local health department until the treatment works returns to normal function;

5. Keep a copy of the log provided by the operator on the property where the system is located in electronic or hard copy form, make the log available to the department upon request, and make a reasonable effort to transfer the log to any future owner;

6. Follow the O&M manual (where available) and keep a copy of the O&M manual in electronic or hard copy form for the system on the property where the system is located, make the O&M manual available to the department upon request, and make a reasonable effort to transfer the O&M manual to any future owner; and

7. Comply with the VPDES permit requirements contained in 9VAC25-110.

C. The operator has the following responsibilities:

1. Perform all testing required in either Part I A or Part I B (9VAC25-110-80) of the General Permit, as appropriate, and in this chapter, unless the owner maintains a waiver in accordance with subsection A of this section. Note: The treatment works will be sampled during normal discharging operations or normal discharging conditions (i.e., operations that are normal for that facility). The operator should not force a discharge in order to collect a formal sample, but the informal sampling should be used to identify any operational problems;

2. Whenever an operator performs a visit that is required by this chapter, he shall do so in such a manner as to accomplish the various responsibilities and assessments required by this chapter through visual or other observations and through laboratory and field tests that are required by this chapter or that he deems appropriate;

3. When performing activities pursuant to a visit that is required by this chapter, the operator is responsible for the entire system, and where applicable, the operator shall follow the approved O&M manual;

4. Provide a written or electronic notification to the owner within 24 hours whenever the operator becomes aware that maintenance or repair of the owner's treatment works is necessary; and

5. Document the results of each site visit in the log and report in accordance with 12VAC5-640-510. Each operator shall keep an electronic or hard copy log for each system for which he is responsible. The operator shall provide a copy of the log to the owner. In addition, the operator shall make the log available to the department upon request. At a minimum, the operator shall record the following items in the log:

a. Results of all testing and sampling;

b. A copy of the Discharge Monitoring Report required by the General Permit;

c. Maintenance, corrective actions, and repair activities that are performed;

d. Recommendations for repair and replacement of system components;

e. Sludge or solids removal; and

f. The date reports were given to the owner.

D. In localities where a public service authority, sanitary district, or other public utility exists which operates and maintains the systems, permitted under this chapter, the requirements for the operation and maintenance contract may be waived by the division provided the owner of the system subscribes to the service and the utility meets the minimum elements described in 12VAC5-640-490, 12VAC5-640-500, and 12VAC5-640-510.

E. In order to competently evaluate system performance, collect samples, interpret sample results, and repair and maintain discharging systems, an individual must be knowledgeable in sewage treatment processes. All individuals who perform maintenance on discharging systems pursuant to 12VAC5-640-500 are required to hold a valid Class IV or higher wastewater works operator license or an alternative onsite sewage system operator license issued by the Board for Waterworks and Wastewater Works Operators and Onsite Sewage System Professionals.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 3.12, eff. July 30, 1992; amended, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-510 Information to be reported electronically

A. Every owner issued an operation permit for a discharging system is responsible for having the results of all mandated testing and inspections submitted to the department in the form and format acceptable to the department.

B. All formal compliance testing, informal testing, repairs, modifications, alterations, expansions and routine maintenance must be reported.

C. All reports and test results must be submitted by the 15th of the month following the month in which the activity occurred.

D. All reports and test results shall be submitted electronically. When formal testing indicates that a discharge limit established in the General Permit is being exceeded or when informal testing indicates a discharging system may be in violation of the General Permit requirements, the owner shall notify the maintenance provider and the department within 24 hours.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 3.13, eff. July 30, 1992; amended, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

12VAC5-640-520 Failure to submit information

Failure to conduct mandatory monitoring or to report monitoring results as required in 12VAC5-640-490 and 12VAC5-640-510 may result in the revocation of the owner's operation permit. The department shall notify the Department of Environmental Quality of the revocation of the operation permit.

History

• Statutory Authority: §§ 32.1-12 and 32.1-164 of the Code of Virginia.
• Historical Notes: Derived from VR355-34-400 § 3.14, eff. July 30, 1992; amended, Virginia Register Volume 32, Issue 6, eff. December 16, 2015.

Agency 30 Department of Medical Assistance Services

Chapter 5 Public Participation Guidelines

Part I Purpose and Definitions

12VAC30-5-10 Purpose

The purpose of this chapter is to promote public involvement in the development, amendment or repeal of the regulations of the Department of Medical Assistance Services. This chapter does not apply to regulations, guidelines, or other documents exempted or excluded from the provisions of the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

History

• Statutory Authority: §§ 2.2-4007.02 and 32.1-324 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 3, eff. November 12, 2008.

12VAC30-5-20 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Administrative Process Act" means Chapter 40 (§ 2.2-4000 et seq.) of Title 2.2 of the Code of Virginia.

"Agency" means the Department of Medical Assistance Services, which is the unit of state government empowered by the agency's basic law to make regulations or decide cases. Actions specified in this chapter may be fulfilled by state employees as delegated by the agency.

"Basic law" means provisions in the Code of Virginia that delineate the basic authority and responsibilities of an agency.

"Commonwealth Calendar" means the electronic calendar for official government meetings open to the public as required by § 2.2-3707 C of the Freedom of Information Act.

''Negotiated rulemaking panel'' or ''NRP'' means an ad hoc advisory panel of interested parties established by an agency to consider issues that are controversial with the assistance of a facilitator or mediator, for the purpose of reaching a consensus in the development of a proposed regulatory action.

"Notification list" means a list used to notify persons pursuant to this chapter. Such a list may include an electronic list maintained through the Virginia Regulatory Town Hall or other list maintained by the agency.

"Open meeting" means any scheduled gathering of a unit of state government empowered by an agency's basic law to make regulations or decide cases, which is related to promulgating, amending or repealing a regulation.

"Person" means any individual, corporation, partnership, association, cooperative, limited liability company, trust, joint venture, government, political subdivision, or any other legal or commercial entity and any successor, representative, agent, agency, or instrumentality thereof.

"Public hearing" means a scheduled time at which members or staff of the agency will meet for the purpose of receiving public comment on a regulatory action.

"Regulation" means any statement of general application having the force of law, affecting the rights or conduct of any person, adopted by the agency in accordance with the authority conferred on it by applicable laws.

"Regulatory action" means the promulgation, amendment, or repeal of a regulation by the agency.

"Regulatory advisory panel" or "RAP" means a standing or ad hoc advisory panel of interested parties established by the agency for the purpose of assisting in regulatory actions.

"Town Hall" means the Virginia Regulatory Town Hall, the website operated by the Virginia Department of Planning and Budget at www.townhall.virginia.gov, which has online public comment forums and displays information about regulatory meetings and regulatory actions under consideration in Virginia and sends this information to registered public users.

"Virginia Register" means the Virginia Register of Regulations, the publication that provides official legal notice of new, amended and repealed regulations of state agencies, which is published under the provisions of Article 6 (§ 2.2-4031 et seq.) of the Administrative Process Act.

History

• Statutory Authority: §§ 2.2-4007.02 and 32.1-324 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 3, eff. November 12, 2008.

Part II Notification of Interested Persons

12VAC30-5-30 Notification list

A. The agency shall maintain a list of persons who have requested to be notified of regulatory actions being pursued by the agency.

B. Any person may request to be placed on a notification list by registering as a public user on the Town Hall or by making a request to the agency. Any person who requests to be placed on a notification list shall elect to be notified either by electronic means or through a postal carrier.

C. The agency may maintain additional lists for persons who have requested to be informed of specific regulatory issues, proposals, or actions.

D. When electronic mail is returned as undeliverable on multiple occasions at least 24 hours apart, that person may be deleted from the list. A single undeliverable message is insufficient cause to delete the person from the list.

E. When mail delivered by a postal carrier is returned as undeliverable on multiple occasions, that person may be deleted from the list.

F. The agency may periodically request those persons on the notification list to indicate their desire to either continue to be notified electronically, receive documents through a postal carrier, or be deleted from the list.

History

• Statutory Authority: §§ 2.2-4007.02 and 32.1-324 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 3, eff. November 12, 2008.

12VAC30-5-40 Information to be sent to persons on the notification list

A. To persons electing to receive electronic notification or notification through a postal carrier as described in 12VAC30-5-30, the agency shall send the following information:

1. A notice of intended regulatory action (NOIRA).

2. A notice of the comment period on a proposed, a reproposed, or a fast-track regulation and hyperlinks to, or instructions on how to obtain, a copy of the regulation and any supporting documents.

3. A notice soliciting comment on a final regulation when the regulatory process has been extended pursuant to § 2.2-4007.06 or 2.2-4013 C of the Code of Virginia.

B. The failure of any person to receive any notice or copies of any documents shall not affect the validity of any regulation or regulatory action.

History

• Statutory Authority: §§ 2.2-4007.02 and 32.1-324 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 3, eff. November 12, 2008.

Part III Public Participation Procedures

12VAC30-5-50 Public comment

A. In considering any nonemergency, nonexempt regulatory action, the agency shall afford interested persons an opportunity to submit data, views, and arguments, either orally or in writing, to the agency. Such opportunity to comment shall include an online public comment forum on the Town Hall.

1. To any requesting person, the agency shall provide copies of the statement of basis, purpose, substance, and issues; the economic impact analysis of the proposed or fast-track regulatory action; and the agency's response to public comments received.

2. The agency may begin crafting a regulatory action prior to or during any opportunities it provides to the public to submit comments.

3. The agency shall afford all interested persons the opportunity to be accompanied by and represented by their own counsel or representative in such activities.

B. The agency shall accept public comments in writing after the publication of a regulatory action in the Virginia Register as follows:

1. For a minimum of 30 calendar days following the publication of the notice of intended regulatory action (NOIRA).

2. For a minimum of 60 calendar days following the publication of a proposed regulation.

3. For a minimum of 30 calendar days following the publication of a reproposed regulation.

4. For a minimum of 30 calendar days following the publication of a final adopted regulation.

5. For a minimum of 30 calendar days following the publication of a fast-track regulation.

6. For a minimum of 21 calendar days following the publication of a notice of periodic review.

7. Not later than 21 calendar days following the publication of a petition for rulemaking.

C. The agency may determine if any of the comment periods listed in subsection B of this section shall be extended.

D. If the Governor finds that one or more changes with substantial impact have been made to a proposed regulation, he may require the agency to provide an additional 30 calendar days to solicit additional public comment on the changes in accordance with § 2.2-4013 C of the Code of Virginia.

E. The agency shall send a draft of the agency's summary description of public comment to all public commenters on the proposed regulation at least five days before final adoption of the regulation pursuant to § 2.2-4012 E of the Code of Virginia.

History

• Statutory Authority: §§ 2.2-4007.02 and 32.1-324 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 3, eff. November 12, 2008; amended, Virginia Register Volume 29, Issue 26, eff. September 27, 2013.

12VAC30-5-60 Petition for rulemaking

A. As provided in § 2.2-4007 of the Code of Virginia, any person may petition the agency to consider a regulatory action.

B. A petition shall include but is not limited to the following information:

1. The petitioner's name and contact information;

2. The substance and purpose of the rulemaking that is requested, including reference to any applicable Virginia Administrative Code sections; and

3. Reference to the legal authority of the agency to take the action requested.

C. The agency shall receive, consider and respond to a petition pursuant to § 2.2-4007 and shall have the sole authority to dispose of the petition.

D. The petition shall be posted on the Town Hall and published in the Virginia Register.

E. Nothing in this chapter shall prohibit the agency from receiving information or from proceeding on its own motion for rulemaking.

History

• Statutory Authority: §§ 2.2-4007.02 and 32.1-324 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 3, eff. November 12, 2008.

12VAC30-5-70 Appointment of regulatory advisory panel

A. The agency may appoint a regulatory advisory panel (RAP) to provide professional specialization or technical assistance when the agency determines that such expertise is necessary to address a specific regulatory issue or action or when individuals indicate an interest in working with the agency on a specific regulatory issue or action.

B. Any person may request the appointment of a RAP and request to participate in its activities. The agency shall determine when a RAP shall be appointed and the composition of the RAP.

C. A RAP may be dissolved by the agency if:

1. The proposed text of the regulation is posted on the Town Hall, published in the Virginia Register, or such other time as the agency determines is appropriate; or

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act.

History

• Statutory Authority: §§ 2.2-4007.02 and 32.1-324 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 3, eff. November 12, 2008.

12VAC30-5-80 Appointment of negotiated rulemaking panel

A. The agency may appoint a negotiated rulemaking panel (NRP) if a regulatory action is expected to be controversial.

B. An NRP that has been appointed by the agency may be dissolved by the agency when:

1. There is no longer controversy associated with the development of the regulation;

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act; or

3. The agency determines that resolution of a controversy is unlikely.

History

• Statutory Authority: §§ 2.2-4007.02 and 32.1-324 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 3, eff. November 12, 2008.

12VAC30-5-90 Meetings

Notice of any open meeting, including meetings of a RAP or NRP, shall be posted on the Virginia Regulatory Town Hall and Commonwealth Calendar at least seven working days prior to the date of the meeting. The exception to this requirement is any meeting held in accordance with § 2.2-3707 D of the Code of Virginia allowing for contemporaneous notice to be provided to participants and the public.

History

• Statutory Authority: §§ 2.2-4007.02 and 32.1-324 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 3, eff. November 12, 2008.

12VAC30-5-100 Public hearings on regulations

A. The agency shall indicate in its notice of intended regulatory action whether it plans to hold a public hearing following the publication of the proposed stage of the regulatory action.

B. The agency may conduct one or more public hearings during the comment period following the publication of a proposed regulatory action. During such hearings, the agency shall afford all interested persons the opportunity to be accompanied by and represented by their own counsel or other representative.

C. An agency is required to hold a public hearing following the publication of the proposed regulatory action when:

1. The agency's basic law requires the agency to hold a public hearing;

2. The Governor directs the agency to hold a public hearing; or

3. The agency receives requests for a public hearing from at least 25 persons during the public comment period following the publication of the notice of intended regulatory action.

D. Notice of any public hearing shall be posted on the Town Hall and Commonwealth Calendar at least seven working daysprior to the date of the hearing. The agency shall also notify those persons who requested a hearing under subdivision C 3 of this section.

History

• Statutory Authority: §§ 2.2-4007.02 and 32.1-324 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 3, eff. November 12, 2008; amended, Virginia Register Volume 29, Issue 26, eff. September 27, 2013.

12VAC30-5-110 Periodic review of regulations

A. The agency shall conduct a periodic review of its regulations consistent with:

1. An executive order issued by the Governor pursuant to § 2.2-4017 of the Administrative Process Act to receive comment on all existing regulations as to their effectiveness, efficiency, necessity, clarity, and cost of compliance; and

2. The requirements in § 2.2-4007.1 of the Administrative Process Act regarding regulatory flexibility for small businesses.

B. A periodic review may be conducted separately or in conjunction with other regulatory actions.

C. Notice of a periodic review shall be posted on the Town Hall and published in the Virginia Register.

History

• Statutory Authority: §§ 2.2-4007.02 and 32.1-324 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 3, eff. November 12, 2008.

Chapter 10 State Plan under Title XIX of the Social Security Act Medical Assistance Program; General Provisions

Part I Single State Agency Organization

12VAC30-10-10 Designation and authority

A. The Department of Medical Assistance Services (DMAS) is the single state agency designated to administer or supervise the administration of the Medicaid program under Title XIX of the Social Security Act. (All references in this plan to "the Medicaid agency" mean the agency named in this subsection.)

12VAC30-20-10 is a certification signed by the State Attorney General identifying the single state agency and citing the legal authority under which it administers or supervises administration of the program.

B. The entire plan under Title XIX is administered or supervised by the state agency named in subsection A of this section.

C. No waivers of the single state agency requirements have ever been granted.

D. Eligibility determinations (including any delegations).

1. The entities that conduct determinations of eligibility for families, adults, and individuals younger than 21 years of age are DMAS, the single state agency under Title IV-A (TANF), and the Exchange, which is a government agency established under § 1311(b)(1) or 1321(c)(1) of the Patient Protection and Affordable Care Act (42 USC § 18001).

2. The entities that conduct determinations of eligibility based on age, blindness, and disability are DMAS and the single state agency under Title IV-A (TANF).

3. DMAS makes the following assurances with regard to eligibility determinations:

a. DMAS is responsible for all Medicaid eligibility determinations.

b. There is a written agreement between DMAS, the Exchange, and the single state agency under Title IV-A. The Exchange and the single state agency under Title IV-A have been delegated authority to determine eligibility for Medicaid eligibility in compliance with 42 CFR 431.10(d).

c. DMAS does not delegate authority to make eligibility determinations to entities other than government entities that maintain personnel standards on a merit basis.

d. The delegated entity is capable of performing the delegated functions.

E. All other provisions of this plan are administered by the Medicaid agency except for those functions for which final authority has been granted to a Professional Standards Review Organization under Title XI of the Act.

F. All other requirements of 42 CFR 431.10 are met.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Subsection (a) derived from VR460-01-2, eff. March 1, 1985; subsection (b) derived from VR460-01-3, eff. October 1, 1976; subsection (c) derived from VR460-01-4, eff. October 1, 1976; subsection (d) derived from VR460-01-5, eff. October 1, 1976; subsections (e) and (f) derived from VR460-01-6, eff. October 1, 1976; Volume 38, Issue 12, eff. March 17, 2022.

12VAC30-10-20 (Repealed.)

History

• Historical Notes: Derived from VR460-01-7, eff. March 1, 1985; amended, Virginia Register Volume 17, Issue 19, eff. August eff. August 1, 2001; Errata, 17:24 VA.R. August 13, 2001; repealed, Virginia Register Volume 38, Issue 12, eff. March 17, 2022.

12VAC30-10-30 Statewide operation

The plan is in operation on a Statewide basis in accordance with all requirements of 42 CFR 431.50.

The plan is State administered.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-8, eff. October 18, 1974.

12VAC30-10-40 State Medical Care Advisory Committee

A. There is an advisory committee to the Medicaid agency director on health and medical care services established in accordance with and meeting all the requirements of 42 CFR 431.12.

B. Tribal consultation. Section 1902(a)(73) of the Social Security Act requires a state in which one or more Indian health programs or Urban Indian organizations furnish health care services to establish a process for the state Medicaid agency to seek advice on a regular, ongoing basis from designees of Indian health programs, whether operated by the Indian Health Service, a Tribe, or Tribal organizations under the Indian Self-Determination and Education Assistance Act (P.L. 93-638) or Urban Indian Organizations under the Indian Health Care Improvement Act (25 USC § 1601 et seq.), concerning Medicaid matters having a direct impact on Indian health programs.

C. The Department of Medical Assistance Services (DMAS) seeks advice on an ongoing basis from federally recognized tribes, Indian health programs, and Urban Indian organizations on matters related to Medicaid and Children's Health Insurance Program programs. DMAS has identified a program designee as an advisory contact, through which the dissemination of information will occur. Designees from each Tribe, Indian health program, and Urban Indian organization receive written communication from DMAS about State Plan amendments, waiver proposals, waiver extensions, waiver amendments, and waiver renewals before any of these documents are submitted to the Centers for Medicare and Medicaid Services. Tribes, Indian health programs, and Urban Indian organizations may request additional information and may request meetings to discuss the proposed changes. DMAS invites these groups to request additional information or offer comments on proposed changes within 30 days of the notification of State Plan amendments, waiver proposals, waiver extensions, waiver amendments, or waiver renewals. For emergency-related submissions, such as a natural disaster or a legislative mandate, DMAS seeks information requests, comments, or proposed changes within 15 days of notification. The coordination of this consultation process wasestablished through an email communication with designees from each Tribe and Indian health program on January 29, 2021. To maintain a cooperative channel of communication and informative dialogue between DMAS and the Tribal organizations, the agency sought out and will continue to seek advice on a regular, ongoing basis via email, teleconference, or meetings.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-01-9, eff. October 18, 1974; amended, Virginia Register Volume 38, Issue 4, eff. November 11, 2021.

12VAC30-10-50 Pediatric immunization program

A. The state has implemented a program for the distribution of pediatric vaccines to program-registered providers for the immunization of federally vaccine-eligible children in accordance with § 1928 as indicated below.

1. The state program will provide each vaccine-eligible child with medically appropriate vaccines according to the schedule developed by the Advisory Committee on Immunization Practices and without charge for the vaccines.

2. The state will outreach and encourage a variety of providers to participate in the program and to administer vaccines in multiple settings, e.g., private health care providers, providers that receive funds under Title V of the Indian Health Care Improvement Act, health programs or facilities operated by Indian tribes, and maintain a list of program-registered providers.

3. With respect to any population of vaccine-eligible children a substantial portion of whose parents have limited ability to speak the English language, the state will identify program-registered providers who are able to communicate with this vaccine-eligible population in the language and cultural context which is most appropriate.

4. The state will instruct program-registered providers to determine eligibility in accordance with § 1928(b) and (h) of the Social Security Act.

5. The state will assure that no program-registered provider will charge more for the administration of the vaccine than the regional maximum established by the Secretary. The state will inform program-registered providers of the maximum fee for the administration of vaccines.

6. The state will assure that no vaccine-eligible child is denied vaccines because of an inability to pay an administration fee.

7. Except as authorized under § 1915(b) of the Social Security Act or as permitted by the Secretary to prevent fraud or abuse, the state will not impose any additional qualifications or conditions, in addition to those indicated above, in order for a provider to qualify as a program-registered provider.

B. The state has not modified or repealed any immunization law in effect as of May 1, 1993, to reduce the amount of health insurance coverage of pediatric vaccines.

C. The state Medicaid agency has coordinated with the state public health agency in the completion of this preprint page.

D. The state agency with overall responsibility for the implementation and enforcement of the provisions of § 1928 is the State Public Health Agency.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-9.1, eff. October 1, 1994.

Part II Coverage and Eligibility

12VAC30-10-60 Application; determination of eligibility and furnishing Medicaid

A. The Medicaid agency meets all requirements of 42 CFR Part 435, Subpart J for processing applications, determining eligibility and furnishing Medicaid.

B. 1. Except as provided in subdivisions 2 and 3 of this subsection, individuals are entitled to Medicaid services under the plan during the three months preceding the month of application, if they were, or on application would have been, eligible. The effective date of prospective and retroactive eligibility is specified in 12VAC30-40-10.

2. For individuals who are eligible for Medicaid cost sharing expenses as qualified Medicare beneficiaries under § 1902(a)(10)(E)(i) of the Act, coverage is available for services furnished after the end of the month in which the individual is first determined to be a qualified Medicare beneficiary. 12VAC30-40-10 specifies the requirements for determination of eligibility for this group.

3. Pregnant women are not entitled to ambulatory prenatal care under the plan during a presumptive eligibility in accordance with § 1920 of the Act. 12VAC30-40-10 specifies the requirements for determination of eligibility of this group.

C. The Medicaid agency elects to enter into a risk contract with an HMO that is qualified under Title XIII of the Public Health Service Act or is provisionally qualified as an HMO pursuant to § 1903(m)(3) of the Social Security Act (42 USC § 1396(m)).

The Medicaid agency elects to enter into a risk contract with an HMO that is not federally qualified, but meets the requirements of 42 CFR 434.20(c) and is defined in 12VAC30-20-60.

D. The Medicaid agency has procedures to take applications, assist applicants, and perform initial processing of applications from those low income pregnant women, infants, and children under age 19, described in § 1902(a)(10)(A)(i)(IV), (a)(10)(A)(i)(VI), (a)(10)(A)(i)(VII), and (a)(10)(A)(ii)(IX) at locations other than those used by the Title IV-A program including FQHCs and disproportionate share hospitals. Such application forms do not include the ADFC form except as permitted by HCFA instructions.

E. Supplemental Nutrition Assistance Program (SNAP) income will be used to support Medicaid eligibility determinations for individuals currently enrolled in SNAP. The Medicaid agency will not alter SNAP procedures while using the reported income to determine Medicaid eligibility using Medicaid rules. The Medicaid agency will obtain all information necessary for a Medicaid eligibility determination that is not in the case record for SNAP from the Medicaid eligibility application.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1315 and 42 USC § 1396 et seq.
• Historical Notes: Subsection A derived from VR460-01-10, eff. June 16, 1993; subsections B and C derived from VR460-01-11, eff. July 1, 1995; subsection D derived from VR460-01-11.1, eff. June 16, 1993; amended, Virginia Register Volume 11, Issue 18, eff. July 1, 1995; Volume 13, Issue 5, eff. January 1, 1997; Volume 37, Issue 24, eff. September 2, 2021.

12VAC30-10-70 Coverage and conditions of eligibility

Medicaid is available to the groups specified in 12VAC30-30-10 et seq., that is, the mandatory categorically needy, other required special groups, specified optional groups, and the medically needy.*

The conditions of eligibility that must be met are specified in 12VAC30-40-10.

All applicable requirements of 42 CFR 435 and § 1902(a)(10)(A)(i)(IV), (V), and (VI), 1902(a)(10)(A)(ii)(XI), 1902(a)(10)(E), 1902(l) and (m), 1905(p), (q) and (s), 1920, and 1925 of the Act are met.

*Medicaid is available to the groups as identified in 12VAC30-30-10, except for the following: eligibility will be denied any individual for a period of twelve (12) months following the date of their conviction for fraud against the Program.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-12, eff. June 16, 1993.

12VAC30-10-80 Residence

Medicaid is furnished to eligible individuals who are residents of the State under 42 CFR 435.403, regardless of whether or not the individuals maintain the residence permanently or maintain it at a fixed address.

See 12VAC30-20-230.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-13, eff. July 1, 1987.

12VAC30-10-90 Blindness

All of the requirements of 42 CFR 435.530 and 42 CFR 435.531 are met. The more restrictive definition of blindness in terms of ophthalmic measurement used in this plan is specified in 12VAC30-30-10.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-14, eff. July 1, 1987.

12VAC30-10-100 Disability

All of the requirements of 42 CFR 435.540 and 435.541 are met. The State uses the same definition of disability used under the SSI program unless a more restrictive definition of disability is specified in 12VAC30-30-10 item 13 of this plan.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-15, eff. June 16, 1993.

12VAC30-10-110 Financial eligibility

The Financial eligibility conditions for Medicaid-only eligibility groups and for persons deemed to be cash assistance recipients are described in 12VAC30-40-10 et seq.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-16 and VR460-01-17, eff. June 16, 1993.

12VAC30-10-120 Medicaid furnished out of state

Medicaid is furnished under the conditions specified in 42 CFR 431.52 to an eligible individual who is a resident of the State while the individual is in another State, to the same extent that Medicaid is furnished to residents in the State.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-18, eff. January 1, 1987.

12VAC30-10-130 Requirements for advance directives

An advance directive shall be defined as a written instruction, such as a living will or durable power of attorney for health care, recognized under state law and relating to the provision of medical care when the individual is incapacitated. Each specified provider receiving funds under this Plan must maintain written policies, procedures, and materials concerning advance directives to ensure compliance with the law. The specified providers shall be: hospitals, nursing facilities, providers of home health care or personal care services, hospices, health maintenance organizations and health insuring organizations.

Refer to 12VAC30-20-70 for further requirements.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-18.1, eff. December 18, 1991.

Part III Services; General Provisions

12VAC30-10-140 Amount, duration, and scope of services: Categorically needy

Medicaid is provided in accordance with the requirements of 42 CFR 440, Subpart B and § 1902(a), 1902(e), 1905(a), 1905(p), 1915, 1920, and 1925 of the Act.

Services for the categorically needy are described below and in 12VAC30-50-10 et seq. These services include:

1. Each item or service listed in § 1905(a)(1) through (5) and (21) of the Act, is provided as defined in 42 CFR Part 440, Subpart A, or, for EPSDT services, § 1905(r) and 42 CFR Part 411, Subpart B.

2. Nurse-midwife services listed in § 1905(a)(17) of the Act, are provided to the extent that nurse-midwives are authorized to practice under state law or regulation and without regard to whether the services are furnished in the area of management of the care of mothers and babies throughout the maternity cycle. Nurse-midwives are permitted to enter into independent provider agreements with the Medicaid agency without regard to whether the nurse-midwife is under the supervision of, or associated with, a physician or other health care provider.

3. Pregnancy-related, including family planning service, and postpartum services for a 60-day period (beginning on the day pregnancy ends) and any remaining days in the month in which the 60th day falls are provided to women who, while pregnant, were eligible for, applied for, and received medical assistance on the day the pregnancy ends.

4. Services for medical conditions that may complicate the pregnancy (other than pregnancy-related or postpartum services) are provided to pregnant women.

5. Services related to pregnancy (including prenatal, delivery, postpartum, and family planning services) and to other conditions that may complicate pregnancy are the same services provided to poverty level pregnant women eligible under the provision of § 1902(a)(10)(A)(i)(IV) and 1902(a)(10)(A)(ii)(IX) of the Act.

6. Home health services are provided to individuals entitled to nursing facility services as indicated in 12VAC30-10-220 of this plan.

7. Inpatient services that are being furnished to infants and children described in § 1902(l)(1)(B) through (D), or § 1905(n)(2) of the Act, on the date the infant or child attains the maximum age for coverage under the approved State plan will continue until the end of the stay for which the inpatient services are furnished.

8. Respiratory care services are not provided to ventilator dependent individuals as indicated in 12VAC30-10-300 of this plan.

9. Services are provided to families eligible under § 1925 of the Act as indicated in 12VAC30-10-350 of this plan.

10. Home and community care for functionally disabled elderly individuals is not covered.

11. Program of All-Inclusive Care for the Elderly (PACE) services as described and limited in Supplement 6 to Attachment 3.1-A (12VAC30-50-320, 12VAC30-50-321, 12VAC30-50-325, and 12VAC30-50-328).

12VAC30-50-10 et seq. identifies the medical and remedial services provided to the categorically needy, specifies all limitations on the amount, duration, and scope of those service, and lists the additional coverage (that is in excess of established service limits) for pregnancy-related services and services for conditions that may complicate the pregnancy.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-01-19, VR460-01-19.1, VR460-01-19.2, eff. June 16, 1993; amended, Virginia Register Volume 12, Issue 2, eff. November 15, 1995; Volume 12, Issue 3, eff. November 29, 1995; Volume 16, Issue 18, eff. July 1, 2000; Volume 23, Issue 16, eff. July 1, 2007.

12VAC30-10-150 Amount, duration, and scope of services: Medically needy

A. This State Plan covers the medically needy. The services described in this section and in Part II (12VAC30-50-40 et seq.) of 12VAC30-50 are provided. Services for the medically needy include:

1. If services in an institution for mental diseases (42 CFR 440.140 and 440.160) or an intermediate care facility for individuals with intellectual disabilities (or both) are provided to any medically needy group, then each medically needy group is provided either the services listed in § 1905(a)(1) through (5) and (17) of the Act, or seven of the services listed in § 1902(a)(1) through (20). The services are provided as defined in 42 CFR 440, Subpart A and in §§ 1902, 1905, and 1915 of the Act.

Subdivision 1 of this subsection is applicable with respect to nurse-midwife services under § 1902(a)(17).

2. Prenatal care and delivery services for pregnant women.

3. Pregnancy-related, including family planning services, and postpartum services for a 60-day period (beginning on the day the pregnancy ends) and any remaining days in the month in which the sixtieth day falls are provided to women who, while pregnant, were eligible for, applied for, and received medical assistance on the day the pregnancy ends.

4. Services for any other medical condition that may complicate the pregnancy (other than pregnancy-related and postpartum services) are provided to pregnant women.

5. Ambulatory services as defined in 12VAC30-50-40 for recipients younger than 18 years of age and recipients entitled to institutional services.

6. Home health services to recipients entitled to nursing facility services as indicated in 12VAC30-10-220.

7. Services for the medically needy do not include services in an institution for mental diseases for individuals older than 65 years of age.

8. Services for the medically needy do not include services in an intermediate care facility for individuals with intellectual disabilities.

9. Services for the medically needy do not include inpatient psychiatric services for individuals younger than 21 years of age, other than those covered under early and periodic screening, diagnosis, and treatment (at 12VAC30-50-130).

10. Services for the medically needy do not include respiratory care services provided to ventilator dependent individuals. See 12VAC30-10-300.

11. Home and community care for functionally disabled elderly individuals is not covered.

12. Program of All-Inclusive Care for the Elderly (PACE) services as described and limited in Supplement 6 to Attachment 3.1-A (12VAC30-50-320, 12VAC30-50-321, 12VAC30-50-325, and 12VAC30-50-328) are covered.

B. Part II (12VAC30-50-40 et seq.) of 12VAC30-50 identifies services provided to each covered group of the medically needy. (Note: Other programs to be offered to medically needy beneficiaries would specify all limitations on the amount, duration, and scope of those services. As PACE provides services to the frail elderly population without such limitation, this is not applicable for this program. In addition, other programs to be offered to medically needy beneficiaries would also list the additional coverage that is in excess of established service limits for pregnancy-related services for conditions that may complicate the pregnancy. As PACE is for the frail elderly population, this also is not applicable for this program.)

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-01-20, VR460-01-20.1, VR460-01-20.2, eff. June 16, 1993; amended, Virginia Register Volume 12, Issue 2, eff. November 15, 1995; Volume 17, Issue 5, eff. January 1, 2001; Volume 25, Issue 14, eff. April 15, 2009; Volume 42, Issue 11, eff. February 11, 2026.

12VAC30-10-160 Amount, duration, and scope of services: Other required special groups

A. Qualified Medicare beneficiaries. Medicare cost sharing for qualified Medicare beneficiaries described in § 1905(p) of the Act is provided only as indicated in 12VAC30-10-310.

B. Qualified disabled and working individuals. Medicare Part A premiums for qualified disabled and working individuals described in § 1902(a)(10)(E)(ii) of the Act are provided as indicated in 12VAC30-10-310.

C. Specified low-income Medicare beneficiaries. Medicare Part B premiums for specified low-income Medicare beneficiaries described in § 1902(a)(10)(E)(iii) of the Act are provided as indicated in 12VAC30-10-310.

D. Qualifying Individuals-1. Medicare Part B premiums for qualifying individuals described in § 1902(a)(10)(E)(iv)(I) and subject to § 1933 of the Act are provided as indicated in 12VAC30-10-310.

E. Qualifying Individuals-2. The portion of the amount of increase to the Medicare Part B premium attributable to the home health provisions for qualifying individuals described in § 1902(a)(10)(E)(iv)(II) and subject to § 1933 of the Act are provided as indicated in 12VAC30-10-310.

F. Families receiving extended Medicaid benefits. Extended Medicaid benefits for families described in § 1925 of the Act are provided as indicated in 12VAC30-10-300.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-01-21, eff. January 1, 1993; amended, Virginia Register Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-10-170 Amount, duration, and scope of services: Limited coverage for certain aliens

A. Aliens granted lawful temporary resident status under § 245A of the Immigration and Nationality Act who meet the financial and categorical eligibility requirements under the approved State Medicaid plan are provided the services covered under the plan if they--

1. Are aged, blind, or disabled individuals as defined in § 1614(a)(1) of the Act;

2. Are children under 18 years of age; or

3. Are Cuban or Haitian entrants as defined in § 501(e)(1) and (2)(A) of P.L. 96-422 in effect on April 1, 1983.

B. Except for emergency services and pregnancy-related services, as described in 42 CFR 447.53(b), aliens granted lawful temporary resident status under § 245A of the Immigration and Nationality Act who are not identified in subdivisions A 1 through A 3 of this section, and who meet the financial and categorical eligibility requirements under the approved State plan are provided services under the plan no earlier than five years from the date the alien is granted temporary resident status.

C. Aliens who are not lawfully admitted for permanent residence or otherwise permanently residing in the United States under color of law who meet the eligibility conditions under the State's approved Medicaid plan, except for the requirement for receipt of AFDC, SSI or a State supplementary payment are provided, Medicaid only for care and services necessary for the treatment of an emergency medical condition (including emergency labor and delivery) as defined in § 1903(v)(3) of the Act.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-21.1, VR460-01-21.2, eff. June 16, 1993.

12VAC30-10-180 Amount, duration, and scope of services: Homeless individuals

Clinic services furnished to eligible individuals who do not reside in a permanent dwelling or do not have a fixed home or mailing address are provided without restrictions regarding the site at which the services are furnished.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-21.2, eff. June 16, 1993.

12VAC30-10-190 Amount, duration, and scope of services: Presumptively eligible pregnant women

Ambulatory prenatal care for pregnant women is not provided during a presumptive eligibility period.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-21.2, eff. June 16, 1993.

12VAC30-10-200 Amount, duration, and scope of services: EPSDT services

The Medicaid agency meets the requirements of § 1902(a)(43), 1905(a)(4)(B), and 1905(r) of the Act with respect to early and periodic screening, diagnostic, and treatment (EPSDT) services.

The Medicaid agency does not have in effect agreements with continuing care providers.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-21.2, eff. June 16, 1993.

12VAC30-10-210 Amount, duration, and scope of services: Comparability of services

Except for those items or services for which § 1902(a), 1902(a)(10), 1903(v), 1915 and 1925 of the Act, 42 CFR 440.250, and § 245A of the Immigration and Naturalization Act, permit exceptions:

A. Services made available to the categorically needy are equal in amount, duration, and scope for each categorically needy person.

B. The amount, duration, and scope of services made available to the categorically needy are equal to or greater than those made available to the medically needy.

C. Services made available to the medically needy are equal in amount, duration, and scope for each person in a medically needy coverage group.

D. Additional coverage for pregnancy-related services and services for conditions that may complicate the pregnancy are equal for categorically and medically needy.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-22, eff. June 16, 1993.

12VAC30-10-220 Amount, duration, and scope of services: home health services

Home health services are provided in accordance with the requirements of 42 CFR 441.15.

A. Home health services are provided to all categorically needy individuals 21 years of age or over.

B. Home health services are provided to all categorically needy individuals under 21 years of age.

C. Home health services are provided to all the medically needy whether the individuals are under or over 21 years of age.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-23, eff. October 1, 1979.

12VAC30-10-230 Amount, duration, and scope of services: Assurance of transportation

Provision is made for assuring necessary transportation of recipients to and from providers. Methods used to assure such transportation are described in 12VAC30-50-530.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-24, eff. April 20, 1994.

12VAC30-10-240 Amount, duration, and scope of services: payment for nursing facility services

The state includes in nursing facility services at least the items and services specified in 42 CFR 483.10(f)(11).

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-01-24, eff. April 20, 1994; amended, Virginia Register Volume 34, Issue 1, eff. October 19, 2017.

12VAC30-10-250 Amount, duration, and scope of services: Methods and standards to assure quality of services

The standards established and the methods used to assure high quality care are described in 12VAC30-60-10 et seq.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-25, eff. October 1, 1976.

12VAC30-10-260 Amount, duration, and scope of services: Family planning services

The requirements of 42 CFR 441.20 are met regarding freedom from coercion or pressure of mind and conscience, and freedom of choice of method to be used for family planning.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-26, eff. October 1, 1976.

12VAC30-10-270 Amount, duration, and scope of services: Optometric services

Optometric services are provided. Services of the type an optometrist is legally authorized to perform are specifically included in the term "physicians' services" under this plan and are reimbursed whether furnished by a physician or an optometrist.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-27, eff. January 1, 1987.

12VAC30-10-280 Amount, duration, and scope of services: Organ transplant procedures

Organ Transplant procedures are provided. Similarly situated individuals are treated alike and any restrictions on the facilities that may, or practitioners who may, provide those procedures is consistent with the accessibility of high quality care to individuals eligible for the procedures under this plan. Standards for the coverage of organ transplant procedures are described at 12VAC30-50-540.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-27, eff. January 1, 1987.

12VAC30-10-290 Amount, duration, and scope of services: Participation by Indian Health Service facilities

Indian Health Service facilities are accepted as providers, in accordance with 42 CFR 431.110(b), on the same basis as other qualified providers.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-28, eff. July 1, 1987.

12VAC30-10-300 Amount, duration, and scope of services: Respiratory care services for ventilator-dependent individuals

Respiratory care services, as defined in § 1902(e)(9)(C) of the Act, are not included in the plan.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-28, eff. July 1, 1987.

12VAC30-10-310 Coordination of Medicaid with Medicare and other insurance: Premiums

A. Medicare Part A and Part B.

1. Qualified Medicare Beneficiary (QMB).

The Medicaid agency pays Medicare Part A premiums (if applicable) and Part B premiums for individuals in the QMB group defined in subsection 25 of 12VAC30-30-10 through the group premium payment arrangement, unless the agency has a buy-in agreement for such payment, as indicated in Part B.

The Medicaid agency does not pay premiums, for which the beneficiary would be liable, for enrollment in an HMO participating in Medicare.

2. Qualified Disabled and Working Individual (QDWI). The Medicaid agency pays Medicare Part A premiums under a group premium payment arrangement for individuals in the QDWI group defined in subsection 26 of 12VAC30-30-10 of this plan.

3. Specified Low-Income Medicare Beneficiary (SLMB). The Medicaid agency pays Medicare Part B premiums under the State buy-in process for individuals in the SLMB group defined in subsection 27 of 12VAC30-30-10 of this plan.

4. Other Medicaid Recipients.

The Medicaid agency pays Medicare Part B premiums to make Medicare Part B coverage available to all individuals who are a) receiving benefits under Titles I, IV-A, X, XIV, or XVI (AABD or SSI); b) receiving State supplements under Title XVI; or c) within a group listed at 42 CFR 431.625(d)(2).

The Medicaid agency does not pay Medicare Part B premiums for individuals receiving Title II or Railroad Retirement benefits.

The Medicaid agency does not pay Medicare Part B premiums for medically needy individuals (Federal Financial Participation is not available for this group).

B. Other Health Insurance. The Medicaid agency pays insurance premiums (through the Health Insurance Premium Payment Program (H.I.P.P.)) for medical or any other type of remedial care to maintain a third party resource for Medicaid covered services provided to eligible individuals (except those over 65 years of age and disabled individuals, entitled to Medicare Part A but not enrolled in Medicare Part B).

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-01-29, VR460-01-29.1, VR460-01-29.2, eff. January 1, 1993; amended, Virginia Register Volume 12, Issue 2, eff. November 15, 1995.

12VAC30-10-320 Coordination of Medicaid with Medicare and other insurance: Deductibles/coinsurance

A. Medicare Part A and B. 12VAC30-80-170 describes the methods and standards for establishing payment rates for services covered under Medicare, and/or the methodology for payment of Medicare deductible and coinsurance amounts, to the extent available for each of the following groups.

1. Qualified Medicare Beneficiaries (QMBS). The Medicaid agency pays Medicare Part A and Part B deductibles and coinsurance amounts for QMBs (subject to any nominal Medicaid copayment) for all services available under Medicare.

2. Other Medicaid Recipients. The Medicaid agency pays Medicaid services also covered under Medicare and furnished to recipients entitled to Medicare (subject to any nominal Medicaid copayment). For services furnished to individuals who are described in 12VAC30-10-310 A 4, payment is only for the amount, duration, and scope of services otherwise available under this plan.

3. Dual Eligible--QMB plus. The Medicaid agency pays Medicare Part A and Part B deductible and coinsurance amounts for all services available under Medicare and pays for all Medicaid services furnished to individuals eligible both as QMBs and categorically or medically needy (subject to any nominal Medicaid copayment).

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-01-29.3, eff. January 1, 1993; amended, Virginia Register Volume 12, Issue 2, eff. November 15, 1995.

12VAC30-10-325 Premiums, deductibles, coinsurance and other cost sharing obligations

A. Pursuant to § 1906 of the Act, the Medicaid agency pays all premiums, deductibles, coinsurance, and other cost sharing obligations for items and services covered under the State plan (subject to any nominal Medicaid copayment) for eligible individuals in employer-based cost-effective group health plans.

B. When coverage for eligible family members is not possible unless ineligible family members enroll, the Medicaid agency pays premiums for enrollment of other family members when cost-effective. In addition, the eligible individual is entitled to services covered by the State plan which are not included in the group health plan. Guidelines for determining cost effectiveness are described in 12VAC30-10-610 H.

C. Pursuant to § 1906A of the Act, the Medicaid agency pays all premiums, deductibles, coinsurance, and other cost sharing obligations for items and services covered under the State Plan, as specified in the qualified employer-sponsored coverage, without regard to limitations specified in § 1916 or § 1916A of the Act, for eligible individuals under age 19 who have access to and elect to enroll in such coverage. The eligible individual is entitled to services covered by the State Plan that are not included in the employer-sponsored coverage. For qualified employer-sponsored coverage, the employer must contribute at least 40% of the premium cost.

When coverage for eligible family members under age 19 is not possible unless an ineligible family member enrolls, the Medicaid agency pays premiums for enrollment of the ineligible family member and, at the option of the parent or legal guardian, other family members that are eligible for coverage under the employer-sponsored plan. The agency also pays deductibles, coinsurance, and other cost-sharing obligations for items and services covered under the State Plan for the ineligible family member. 12VAC30-20-205 provides a detailed description of this program.

D. The Medicaid agency pays premiums for individuals described in subsection 19 of 12VAC30-30-10.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-01-29.4, eff. April 1, 1993; amended, Virginia Register Volume 29, Issue 2, eff. November 8, 2012.

12VAC30-10-330 Medicaid for individuals age 65 or over in institutions for mental diseases

Medicaid is provided for individuals 65 years of age or older who are patients in institutions for mental diseases.

The requirements of 42 CFR 441, Subpart C, and 42 CFR 431.620(c) and (d) are met.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-30, eff. October 1, 1976.

12VAC30-10-340 Special requirements applicable to sterilization procedures

All requirements of 42 CFR 441, Subpart F are met.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-31, eff. March 31, 1979.

12VAC30-10-350 Families receiving extended Medicaid benefits

A. Services provided to families during the first 6-month period of extended Medicaid benefits under § 1925 of the Act are equal in amount, duration, and scope to services provided to categorically needy AFDC recipients as described in 12VAC30-50-10 (or may be greater if provided though a caretaker relative employer's health insurance plan).

B. Services provided to families during the second 6-month period of extended Medicaid benefits under § 1925 of the Act are equal in amount, duration and scope to services provided to categorically needy AFDC recipients as described in 12VAC30-50-10 et seq. (or may be greater if provided through a caretaker relative employer's health insurance plan).

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-31.1, eff. June 16, 1993.

12VAC30-10-360 [Reserved]. (Reserved)

Part IV General Program Administration

12VAC30-10-400 Methods of administration

The Medicaid agency employs methods of administration found by the Secretary of Health and Human Services to be necessary for the proper and efficient operation of the plan.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-32, eff. July 1, 1987.

12VAC30-10-410 Hearings for applicants and recipients

The Medicaid agency has a system of hearings that meets all the requirements of 42 CFR 431, Subpart E.

The Medicaid agency is responsible for all Medicaid fair hearings. Medicaid fair hearings are de novo proceedings and are conducted pursuant to Part I (12VAC30-110-10 et seq.) of Eligibility and Appeals.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-01-33, eff. November 5, 1990; amended, Virginia Register Volume 38, Issue 12, eff. March 17, 2022; Volume 42, Issue 21, eff. July 16, 2026.

12VAC30-10-420 Safeguarding information on applicants and recipients

Under State statute which imposes legal sanctions, safeguards are provided that restrict the use or disclosure of information concerning applicants and recipients to purposes directly connected with the administration of the plan.

All other requirements of 42 CFR 431, Subpart F are met.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-34, eff. February 26, 1992.

12VAC30-10-430 Medicaid quality control

A. A system of quality control is implemented in accordance with 42 CFR 431, Subpart P.

B. The state does not operate a claims processing assessment system that meets the requirements of 42 CFR 431.808, 42 CFR 431.818, 42 CFR 431.830, 42 CFR 431.832, 42 CFR 431.834, and 42 CFR 431.836. The state has an approved Medicaid Enterprise System (MES).

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-01-35, eff. July 1, 1987; amended, Virginia Register Volume 34, Issue 1, eff. October 19, 2017; Volume 42, Issue 20, eff. June 17, 2026.

12VAC30-10-435 Medicaid prohibition on payments to institutions or entities located outside of the United States

The state shall not provide any payments for items or services provided under the state plan or under a waiver to any financial institution or entity located outside of the United States.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 27, Issue 20, eff. July 6, 2011.

12VAC30-10-440 Medicaid Agency Fraud Detection and Investigation Program

The Medicaid agency has established and will maintain methods, criteria, and procedures that meet all requirements of 42 CFR 455.13 through 455.21 and 455.23 for prevention and control of program fraud and abuse.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-36, eff. January 1, 1989.

12VAC30-10-441 Medicaid agency fraud detection and investigation program

The Medicaid agency has established a mechanism to receive reports from beneficiaries and others and compile data concerning alleged instances of waste, fraud, and abuse relating to the operation of this chapter.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 15, Issue 26, eff. October 13, 1999.

12VAC30-10-445 Recovery audit contractors

A. The state has established a program under which it will contract with one or more recovery audit contractors (RACs) for the purpose of identifying underpayments and overpayments of Medicaid claims under the State Plan and under any waiver of the State Plan.

B. The state/Medicaid agency has contracts of the type listed in § 1902(a)(42)(B)(ii)(I) of the Act. All contracts meet the requirements of the statute. RACs are consistent with the statute.

C. The state will make payments to the RACs only from amounts recovered.

D. The state will make payments to the RACs on a contingent basis for collecting overpayments.

E. The state attests that the contingency fee rate paid to the Medicaid RAC will not exceed the highest rate paid to Medicare RACs as published in the Federal Register.

F. The payment methodology used to determine state payments to Medicaid RACs for the identification of underpayments will be based upon the percentage of the contingency fee.

G. The state has an adequate appeal process in place for entities to appeal any adverse determination made by the Medicaid RACs.

H. The state assures that the amounts expended by the state to carry out the program will be amounts expended as necessary for the proper and efficient administration of the State Plan or a waiver of the plan.

I. The state assures that the recovered amounts will be subject to a state's quarterly expenditure estimates and funding of the state's share.

J. Efforts of the Medicaid RACs will be coordinated with other contractors or entities performing audits of entities receiving payments under the State Plan or waiver in the state, and/or state and federal law-enforcement entities and the CMS Medicaid Integrity Program.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 2, eff. October 25, 2012.

12VAC30-10-450 Reports

The Medicaid agency will submit all reports in the form and with the content required by the Secretary, and will comply with any provisions that the Secretary finds necessary to verify and assure the correctness of the reports. All requirements of 42 CFR 431.16 are met.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-37, eff. October 1, 1977.

12VAC30-10-460 Maintenance of records

The Medicaid agency maintains or supervises the maintenance of records necessary for the proper and efficient operation of the plan, including records regarding applications, determination of eligibility, the provision of medical assistance, and administrative costs, and statistical, fiscal and other records necessary for reporting and accountability, and retains these records in accordance with Federal requirements. All requirements of 42 CFR 431.17 are met.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-38, eff. October 1, 1977.

12VAC30-10-470 Availability of agency program manuals

Program manuals and other policy issuances that affect the public, including the Medicaid agency's rules and regulations governing eligibility, need, and amount of assistance, recipient rights and responsibilities, and services offered by the agency are maintained in the State office and in each local and district office for examination, upon request, by individuals for review, study, or reproduction. All requirements of 42 CFR 431.18 are met.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-39, eff. March 29, 1974.

12VAC30-10-480 Reporting provider payments to Internal Revenue Service

These are procedures implemented in accordance with 42 CFR 433.37 for identification of providers of services by social security number or by employer identification number and for reporting the information required by the Internal Revenue Code (26 USC 6041) with respect to payment for services under the plan.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-40, eff. March 29, 1974.

12VAC30-10-490 Free choice of providers

A. Except as provided in subsection B of this section, the Medicaid agency assures that an individual eligible under the plan may obtain Medicaid services from any institution, agency, pharmacy, person or organization that is qualified to perform the services, including an organization that provides these services or arranges for their availability on a prepayment basis.

B. Subsection A of this section does not apply to services furnished to an individual:

1. Under an exception allowed under 42 CFR 431.54, subject to the limitations in subsection C of this section;

2. Under a waiver approved under 42 CFR 431.55, subject to the limitations in subsection C of this section;

3. By an individual or entity excluded from participation in accordance with § 1902(p) of the Act; or

4. By individuals or entities who have been convicted of a felony under federal or state law and for which the state determines that the offense is inconsistent with the best interests of the individual eligible to obtain Medicaid services.

C. Enrollment of an individual eligible for medical assistance in a primary care case management system described in § 1915(b)(1), a health maintenance organization, or a similar entity shall not restrict the choice of the qualified person from whom the individual may receive emergency services or services under § 1905(a)(4)(C).

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-01-41, eff. June 16, 1993; amended, Virginia Register Volume 15, Issue 26, eff. October 13, 1999.

12VAC30-10-500 Relations with standard-setting and survey agencies

A. The State agency utilized by the Secretary to determine qualification of institutions and suppliers of services to participate in Medicare is responsible for establishing and maintaining health standards for private or public institutions (exclusive of Christian Science sanatoria) that provide services to Medicaid recipients. This agency is the Department of Health.

B. The State authorities responsible for establishing and maintaining standards, other than those relating to health, for public or private institutions that provide services to Medicaid recipients are: Department of Behavioral Health and Developmental Services, State Corporation Commission, Office of State Fire Marshall.

C. 12VAC30-20-100 describes the standards specified in subsections A and B of this section that are kept on file and made available to the Health Care Financing Administration on request.

D. The Virginia Department of Health (agency), which is the agency responsible for licensing health institutions, determines if institutions and agencies meet the requirements for participation in the Medicaid program. The requirements in 42 CFR 431.610(e), (f), and (g) are met.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Subsections A, B, and C derived from VR460-01-42, eff. March 29, 1974; subsection D derived from VR460-01-43, eff. March 29, 1974; amended, Virginia Register Volume 42, Issue 11, eff. February 11, 2026.

12VAC30-10-510 Consultation to medical facilities

A. Consultative services are provided by health and other appropriate State agencies to hospitals, nursing facilities, home health agencies, clinics and laboratories in accordance with 42 CFR 431.105(b).

B. Similar services are provided to other types of facilities providing medical care to individuals receiving services under the programs specified in 42 CFR 431.105(b):

HURA and RHI Projects

Neighborhood Health Projects

Multiple Handicap Projects

Children and Youth Projects

Maternal and Infant Care Projects

Dental Health Projects

Cerebral Palsy Centers

Family Planning Clinics

Child Development Clinics

Crippled Children Programs

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-44, eff. October 1, 1977.

12VAC30-10-520 Required provider agreement

With respect to agreements between the Medicaid agency and each provider furnishing services under the plan:

A. For all providers, the requirements of 42 CFR 431.107 and Subparts A and B of 42 CFR Part 442 (if applicable) are met.

B. For providers of NF services, the requirements of Subpart B of 42 CFR Part 483 and § 1919 of the Act are also met in addition to the requirements in subsections C, D, and E of this subsection.

C. For providers of ICF/IID services, the requirements of participation in Subpart I of 42 CFR Part 483 are also met.

D. Ambulatory prenatal care is not provided to pregnant women during a presumptive eligibility period.

E. For each provider receiving funds under the plan, all the requirements for advance directives of § 1902(w) are met:

1. Hospitals, nursing facilities, providers of home health care or personal care services, hospice programs, health maintenance organizations and health insuring organizations are required to do the following:

a. Maintain written policies and procedures with respect to all adult individuals receiving medical care by or through the provider or organization about their rights under state law to make decisions concerning medical care, including the right to accept or refuse medical or surgical treatment and the right to formulate advance directives;

b. Provide written information to all adult individuals on their policies concerning implementation of such rights;

c. Document in the individual's medical records whether or not the individual has executed an advance directive;

d. Not to discriminate against an individual based on whether or not the individual has executed an advance directive including the provision of care;

e. Ensure compliance with requirements of state law (whether statutory or recognized by the courts) concerning advance directives; and

f. Provide (individually or with others) for education for staff and the community on issues concerning advance directives.

2. Providers will furnish the written information described in subdivision 1 a of this subsection to all adult individuals at the time specified in this subdivision:

a. Hospitals at the time an individual is admitted as an inpatient;

b. Nursing facilities when the individual is admitted as a resident;

c. Providers of home health or personal care services before the individual comes under the care of the provider;

d. Hospice program at the time of initial receipt of hospice care by the individual from the program; and

e. Health maintenance organizations at the time of enrollment of the individual with the organization.

3. 12VAC30-20-240 describes law of the state (whether statutory or as recognized by the courts of the state) concerning advance directives.

As a condition of participation in the Virginia Medical Assistance Program all nursing facilities must agree that when an individual is discharged to a hospital, the nursing facility from which the individual is discharged shall ensure that the individual shall be given an opportunity to be readmitted to the facility at the time of the next available vacancy.

The only acceptable reasons for failure to readmit a specific individual who has been discharged to a hospital shall be the individual is certified for a level of care not provided by the facility, the individual is judged by a physician to be a danger to himself or others, or the individual, who at the time of readmission has an outstanding payment to the nursing facility for which he is responsible in accordance with Medicaid regulations.

F. The Department of Medical Assistance Services (DMAS) shall conduct provider screening according to the requirements of Subpart E of 42 CFR Part 455. DMAS shall terminate or deny enrollment to any provider in accordance with the requirements of 42 CFR 455.416.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Paragraphs A through D derived from VR460-01-45, eff. June 16, 1993; paragraph E 1 a through E 1 e, derived from VR460-01-45.1, eff. June 16, 1993; paragraph E 1 f, E 2, and E 3 derived from VR460-01-45.2, eff. June 16, 1993; amended, Virginia Register Volume 33, Issue 2, eff. October 19, 2016; Volume 34, Issue 1, eff. October 19, 2017.

12VAC30-10-530 Utilization and quality control

A. A Statewide program of surveillance and utilization control has been implemented that safeguards against unnecessary or inappropriate use of Medicaid services available under this plan and against excess payments, and that assesses the quality of services. The requirements of 42 CFR Part 456 are met directly.

Quality review requirements described in § 1902(a)(30)(C) of the Act relating to services furnished by HMO's under contract are undertaken through contract with the PRO designated under 42 CFR Part 462.

B. The Medicaid agency meets the requirements of 42 CFR Part 456, Subpart C, for control of the utilization of inpatient hospital services. No waivers have been granted.

C. The Medicaid agency meets the requirements of 42 CFR Part 456, Subpart D, for control of utilization of inpatient services in mental hospitals.

No waivers have been granted.

D. The Medicaid agency meets the requirements of 42 CFR Part 456, Subpart E, for the control of utilization of skilled nursing facility services.

No waivers have been granted.

E. The Medicaid agency meets the requirements of 42 CFR Part 456, Subpart F, for control of the utilization of intermediate care facility services as provided through:

1. Direct review by personnel of the medical assistance unit of the state agency.

2. Personnel under contract to the medical assistance unit of the state agency.

The program will allow a maximum of 10 administrative days for placement and transfer from NF to community in order to make an orderly transfer or placement possible without potential harm or trauma to the patient in accordance with 42 CFR 456.4.

One of the semiannual utilization reviews required by 42 CFR 456.434(b)(1) for ICF/MR recipients will be conducted by the Virginia Department of Health as part of the inspection of care visit. The second utilization review will be conducted by personnel of the Medical Assistance unit of the state agency.

F. The Medicaid agency meets the requirements of § 1902(a)(30) of the Act for control of the assurance of quality furnished by each health maintenance organization under contract with the Medicaid agency. Independent, external quality reviews are performed annually by a Utilization and Quality Control Peer Review Organization designated under 42 CFR Part 462 that has a contract with the agency to perform those reviews.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Subsection A derived from VR460-01-46, eff. June 16, 1993; subsection B; am from VR460-01-47, eff. August 16, 1985; subsection C derived from VR460-01-48, eff. September 30, 1985; subsection D derived from VR460-01-49, eff. August 16, 1985; subsection E derived from VR460-01-50, eff. February 15, 1990; subsection F derived from VR460-01-50.1, eff. June 16, 1993; amended, Virginia Register Volume 13, Issue 5, eff. January 1, 1997.

12VAC30-10-540 Inspection of care in intermediate care facilities for persons with intellectual and developmental disabilities, facilities providing inpatient...

All applicable requirements of 42 CFR 456, Subpart I are met with respect to periodic inspections of care and services.

Inspection of care in intermediate care facilities for persons with intellectual and developmental disabilities is completed through contractual arrangements with the Virginia Department of Health.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia, 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-01-51, eff. June 16, 1993; amended, Virginia Register Volume 35, Issue 24, eff. August 22, 2019.

12VAC30-10-550 Relations with state health and vocational rehabilitation agencies and Title V grantees

The Medicaid agency has cooperative arrangements with State health and vocational rehabilitation agencies and with Title V grantees, that meet the requirements of 42 CFR 431.615.

12VAC30-20-120 describes the cooperative arrangements with the health and vocational rehabilitation agencies.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-52, eff. March 29, 1974.

12VAC30-10-560 Liens and recoveries

Liens are not imposed against an individual's property.

A. Adjustments or recoveries for Medicaid claims correctly paid are as follows: See 12VAC30-20-141.

1. For permanently institutionalized individuals, adjustments or recoveries are made from the individual's estate.

2. For any individual who received medical assistance at age 55 or older, recovery of payments are made for nursing facility services, home- and community-based services, and related hospital and prescription drug services.

Payments are recovered for all services covered under the plan which are provided to individuals at age 55.

3. If an individual covered under a qualified long-term care partnership insurance policy pursuant to § 32.1-325 of the Code of Virginia received benefits for which assets or resources were disregarded as provided for in 12VAC30-40-290 G, the Commonwealth does not seek adjustment or recovery from the individual's estate for the amount of assets or resources disregarded.

B. No money payments under another program are reduced as a means of recovering Medicaid claims incorrectly paid.

C. Liens. See 12VAC30-20-130.

1. Specifies the process for determining that an institutionalized individual cannot reasonably be expected to be discharged from the medical institution and return home; the description of the process meets the requirements of 42 CFR 433.36(d).

The Commonwealth does not impose liens; therefore, this subsection is not applicable.

2. Specifies the criteria by which a son or daughter can establish that he or she has been providing care under 42 CFR 433.36(f).

The Commonwealth does not impose liens; therefore, this subsection is not applicable.

3. Definitions: individual's home; equity interest in home; residing in home for at least 1 or 2 years, on a continuing basis; discharge from the medical institution and return home; and lawfully residing.

The Commonwealth does not impose liens; therefore, this subsection is not applicable.

D. Estate recoveries.

12VAC30-20-141 (Attachment 4.17-C) specifies the policy for estate recoveries.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-01-53, VR460-01-53.1, eff. March 20, 1983; amended, Virginia Register Volume 11, Issue 26, eff. October 18, 1995; Volume 23, Issue 14, eff. September 1, 2007; Volume 25, Issue 21, eff. July 23, 2009.

12VAC30-10-570 Recipient cost sharing and similar charges

A. Unless a waiver under 42 CFR 431.55(g) applies, deductibles, coinsurance rates, and copayments do not exceed the maximum allowable charges under 42 CFR 447.54.

B. With respect to individuals covered as categorically needy or as qualified Medicare beneficiaries (as defined in § 1905(p)(1) of the Act) under the plan:

1. No enrollment fee, premium, or similar charge is imposed under the plan.

2. No deductible, coinsurance, copayment, or similar charge is imposed under the plan for the following:

a. Services to individuals under age 21. Reasonable categories of individuals who are age 18 or older, but under age 21, to whom charges apply are listed below, if applicable.

b. Services to pregnant women related to the pregnancy or any other medical condition that may complicate the pregnancy.

c. Charges apply for services to pregnant women unrelated to the pregnancy.

d. Services furnished to any individual who is an inpatient in a hospital, long-term care facility, or other medical institution, if the individual is required, as a condition of receiving medical services in the institution, to spend for medical care costs all but a minimal amount of his or her income required for personal needs.

e. Emergency services if the services meet the requirements in 42 CFR 447.53(b)(4).

f. Family planning services and supplies furnished to individuals of childbearing age.

g. Services furnished by a health maintenance organization in which the individual is enrolled.

h. Services furnished to an individual receiving hospice care, as defined in § 1905(o) of the Act.

3. Unless a waiver under 42 CFR 431.55(g) applies, nominal deductible, coinsurance, copayment, or similar charges are imposed for services that are not excluded from such charges under item B 2 above:

a. For any service, no more than one type of charge is imposed.

b. Charges apply to services furnished to persons 21 or older.

c. For the categorically needy and qualified Medicare beneficiaries, 12VAC30-20-150 specifies the:

(1) Service(s) for which a charge is applied;

(2) Nature of the charge imposed on each service;

(3) Amount(s) of and basis for determining the charge(s);

(4) Method used to collect the charge(s);

(5) Basis for determining whether an individual is unable to pay the charge and the means by which such an individual is identified to providers; and

(6) Procedures for implementing and enforcing the exclusions from cost sharing contained in 42 CFR 447.53(b).

No cumulative maximum applies to deductible, coinsurance, or copayment charges imposed on a specified time period.

C. Individuals are covered as medically needy under the plan.

1. No enrollment fee, premium, or similar charge is imposed.

2. No deductible, coinsurance, copayment, or similar charge is imposed under the plan for:

a. Services to individuals under 21; reasonable categories of individuals who are age 18, but under age 21, to whom charges apply are listed below, if applicable.

b. Services to pregnant women related to the pregnancy or any other medical condition that may complicate the pregnancy.

c. Charges apply for services to pregnant women unrelated to the pregnancy.

d. Services furnished to any individual who is an inpatient in a hospital, long-term care facility, or other medical institution, if the individual is required, as a condition of receiving services in the institution, to spend for medical care costs all but a minimal amount of his income required for personal needs.

e. Emergency services if the services meet the requirements in 42 CFR 447.53(b)(4).

f. Family planning services and supplies furnished to individuals of childbearing age.

g. Services furnished to an individual receiving hospice care, as defined in § 1905(o) of the Act.

h. Services provided by a health maintenance organization (HMO) to enrolled individuals.

Unless a waiver under 42 CFR 431.55(g) applies, nominal deductible, coinsurance, copayment, or similar charges are imposed on services that are not excluded from such charges under item B 2 above.

(1) For any service, no more than one type of charge is imposed.

(2) Charges apply to services furnished to persons 21 or older.

Reasonable categories of individuals who are 18 years of age, but under 21, to whom charges apply are listed below, if applicable.

(3) For the medically needy, and other optional groups, 12VAC30-20-160 specifies the:

(a) Service(s) for which charge(s) is applied;

(b) Nature of the charge imposed on each service;

(c) Amount(s) of and basis for determining the charge(s);

(d) Method used to collect the charge(s);

(e) Basis for determining whether an individual is unable to pay the charge(s) and the means by which such an individual is identified to providers;

(f) Procedures for implementing and enforcing the exclusions from cost sharing contained in 42 CFR 447.53(b); and

(g) No cumulative maximum applies to deductible, coinsurance, or copayment charges imposed on a family during a specified time period.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Subsections A and B 1 through B 2 b derived from VR460-01-54, eff. June 6, 1993; subsections B 2 c through h derived from VR460-01-55, eff. June 16, 1993; subsections B 3 a and b, derived from VR460-01-56, eff. June 16, 1993; subsection B 3 c derived from VR460-01-56.1, eff. June 16, 1993; subsection C 1 and 2 a derived from VR460-01-56.3, eff. June 16, 1993; subsections C 2 b through h derived from VR460-01-56.4, eff. June 16, 1993; subsections C 3 a and b derived from VR460-01-56.5, eff. June 16, 1993; subsection C 3 c derived from VR460-01-56.6, eff. June 16, 1993.

12VAC30-10-580 Payment for services

A. Medicaid agency meets the requirements of 42 CFR 447, Subpart C, and § 1902(a)(13) and 1923 of the Act with respect to payment for inpatient hospital services.

Chapter 70 (12VAC30-70-10 et seq.) describes the methods and standards used to determine rates for payment for inpatient hospital services.

Inappropriate level of care days are not covered.

B. In addition to the services specified in subsections A, D, K, L, and M of this section, the Medicaid agency meets the following requirements:

1. Section 1902(a)(13)(E) of the Act regarding payment for services furnished by federally qualified health centers (FQHCs) under § 1905(a)(2)(C) of the Act. The agency meets the requirements of § 6303 of the State Medicaid Manual (HFCA-Pub. 45-6) regarding payment for FQHC services. Chapter 80 (12VAC30-80-10 et seq.) describes the method of payment and how the agency determines the reasonable costs of the services (e.g., cost reports, cost or budget reviews, or sample surveys).

2. Sections 1902(a)(13)(E) and 1926 of the Act, and 42 CFR 447, Subpart D, with respect to payment for all other types of ambulatory services provided by rural health clinics under the plan.

Chapter 80 (12VAC30-80-10 et seq.) describes the methods and standards used for the payment of each of these services except for inpatient hospital, nursing facility services, and services in intermediate care facilities for individuals with intellectual disabilities that are described in other attachments.

12VAC30-80-170 describes the general methods and standards used for establishing payment for Medicare Part A and B deductible/coinsurance.

C. Payment is made to reserve a bed during a recipient's temporary absence from an inpatient facility, as described in 12VAC30-20-170.

D. 1. The Medicaid agency meets the requirements of 42 CFR 447, Subpart C, with respect to payments for skilled nursing and intermediate care facility services.

12VAC30-90-10 describes the methods and standards used to determine rates for payment for skilled nursing and intermediate care facility services.

2. The Medicaid agency does not provide payment for skilled nursing facility services to a swing-bed hospital.

3. The Medicaid agency does not provide payment for intermediate care facility services to a swing-bed hospital.

4. Subdivision 1 of this subsection is applicable with respect to intermediate care facility services; such services are provided under this plan.

E. The Medicaid agency meets all requirements of 42 CFR 447.45 for timely payment of claims.

12VAC30-20-180 specifies, for each type of service, the definition of a claim for purposes of meeting these requirements.

F. The Medicaid agency limits participation to providers who meet the requirements of 42 CFR 447.15.

No provider participating under this plan may deny services to any individual eligible under the plan on account of the individual's inability to pay a cost sharing amount imposed by the plan in accordance with 42 CFR 431.55(g) and 447.53. This service guarantee does not apply to an individual who is able to pay, nor does an individual's inability to pay eliminate the individual's liability for the cost sharing change.

G. The Medicaid agency assures appropriate audit of records when payment is based on costs of services or on a fee plus cost of materials.

H. The Medicaid agency meets the requirements of 42 CFR 447.203 for documentation and availability of payment rates.

I. The Medicaid agency's payments are sufficient to enlist enough providers so that services under the plan are available to recipients at least to the extent that those services are available to the general population.

J. The Medicaid agency meets the requirements of 42 CFR 447.205 for public notice of any changes in statewide method or standards for setting payment rates.

K. The Medicaid agency meets the requirements of § 1903(v) of the Act with respect to payment for medical assistance furnished to qualified aliens who entered the United States on or after August 22, 1996, who are not eligible for Medicaid for five years after their entry and nonqualified aliens, including illegal aliens and legal nonimmigrants who are otherwise eligible. Payment is made only for care and services that are necessary for the treatment of an emergency condition, as defined in § 1903(v) of the Act.

L. The Medicaid agency meets the requirements of § 1903(i)(14) of the Act with respect to payment for physician services furnished to children under 21 years of age and pregnant women. Payment for the physician services furnished by a physician to a child or pregnant woman is made only to physicians who meet one of the requirements listed under this section of the Act.

M. Medicaid reimbursement for administration of vaccines under the Pediatric Immunization Program.

A provider may impose a charge for the administration of a qualified pediatric vaccine as stated in § 1928(c)(2)(C)(ii) of the Act. Within this overall provision, Medicaid reimbursement to providers will be administered as follows:

1. The state sets a payment rate below the level of the regional maximum established by the Department of Health and Human Services Secretary.

The state pays $11 per vaccine administration.

2. Medicaid beneficiary access to immunizations is assured through the following methodology:

The Commonwealth will demonstrate access to such services by the Commonwealth's fee per vaccine administration being higher than that of a major insurance company.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Subsection A derived from VR460-01-57, eff. June 16, 1993; subsection B derived from VR460-01-58, eff. June 16, 1993; subsection C derived from VR460-01-59, eff. September 16, 1977; subsection D derived from VR460-01-60, eff. December 1, 1987; subsection E derived from VR460-01-61, eff. August 23, 1979; subsection F derived from VR460-01-62, eff. July 1, 1987; subsection G derived from VR460-01-63, eff. September 30, 1979; subsection H derived from VR460-01-64, eff. September 30, 1979; subsection I derived from VR460-01-65, eff. September 30, 1979; subsections J and K derived from VR460-01-66, eff. June 16, 1993; amended, Virginia Register Volume 11, Issue 26, eff. November 1, 1995; Volume 12, Issue 2, eff. November 15, 1995; Volume 13, Issue 18, eff. July 1, 1997; Volume 42, Issue 11, eff. February 11, 2026.

12VAC30-10-590 Direct payments to certain recipients for physicians' or dentists' services

No direct payments are made to recipients.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-67, eff. September 16, 1977.

12VAC30-10-600 Prohibition against reassignment of provider claims

Payment for Medicaid services furnished by any provider under this plan is made only in accordance with the requirements of 42 CFR 447.10.

In the case of services furnished (during periods that do not exceed 14 continuous days in the case of an informal reciprocal arrangement or 90 continuous days (or such longer period as the Secretary may provide) in the case of an arrangement involving per diem, or other fee-for-time compensation) by or incident to the services of one physician to the patient of another physician who submits the claim for such services, payment shall be made to the physician submitting the claim (as if the services were furnished by, or incident to, the physician's services), but only if the claim identifies (in a manner specified by the Secretary) the physician who furnished the services.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-68, eff. November 5, 1990.

12VAC30-10-610 Third-party liability

A. The Medicaid agency meets all requirements of:

1. 42 CFR 433.138 and 433.139;

2. 42 CFR 433.145 through 433.148;

3. 42 CFR 433.151 through 433.154; and

4. Section 1902(a)(25)(H) and (a)(25)(I) of the Social Security Act.

B. 12VAC30-20-190, governing the identification of liable resources with respect to third-party liability:

1. Specifies the frequency with which the data exchanges required in 42 CFR 433.138(d)(1), (d)(3), and (d)(4) and the diagnosis and trauma code edits required in 42 CFR 433.138(e) are conducted;

2. Describes the methods the agency uses for meeting the follow-up requirements contained in 42 CFR 433.138(g)(1)(i) and (g)(2)(i);

3. Describes the methods the agency uses for following up on information obtained through the state motor vehicle accident report file data exchange required under 42 CFR 433.138(d)(4)(ii) and specifies the timeframes for incorporation into the eligibility case file and into its third-party database and third-party recovery unit of all information obtained through the follow-up that identifies legally liable third-party resources; and

4. Describes the methods the agency uses for following up on paid claims identified under 42 CFR 433.138(a) (methods include a procedure for periodically identifying those trauma codes that yield the highest third-party collections and giving priority to following up on those codes) and specifies the timeframes for incorporation into the eligibility case file and into its third-party database and third-party recovery unit of all information obtained through the follow-up that identifies legally liable third-party resources.

C. Providers are not required to bill liable third parties when services covered under the plan are furnished to an individual on whose behalf child support enforcement is being carried out by the state Title IV-D agency.

D. 12VAC30-20-200, governing the payment of claims with respect to third-party liability, specifies:

1. The method used in determining a provider's compliance with the third-party billing requirements at 42 CFR 433.139(b)(3)(ii)(C).

2. The threshold amount or other guideline used in determining whether to seek recovery or reimbursement from a liable third party, or the process by which the agency determines that seeking recovery of reimbursement would not be cost-effective.

3. The dollar amount or time period the state uses to accumulate billings from a particular liable third party in making the decision to seek recovery of reimbursement.

E. The Medicaid agency ensures that the state has in effect the laws that require third parties to comply with the provisions, including those that require third parties to provide the state with coverage, eligibility, and claims data under § 1902(a)(25) of the Social Security Act, and specifies the compliance with § 1902(a)(25)(E) and (a)(25)(F) of the Social Security Act.

F. The Medicaid agency ensures that laws are in effect that bar liable third-party payers from refusing payment for an item or service solely on the basis that such item or service did not receive prior authorization under the third-party payer's rules. These laws comply with the provisions of § 202 of the Consolidated Appropriations Act of 2022.

G. The Medicaid agency ensures that the provider furnishing a service for which a third party is liable follows the restrictions specified in 42 CFR 447.20.

H. The Medicaid agency has written cooperative agreements for the enforcement of rights to and collection of third-party benefits assigned to the state as a condition of eligibility for remedial assistance with the state Title IV-D agency. The requirements of 42 CFR 433.152(b) are met.

I. The Medicaid agency ensures that the state has in effect the laws relating to medical child support under § 1908 of the Social Security Act.

J. The Medicaid agency specifies the guidelines used in determining the cost-effectiveness of an employer-based group health plan; the state provides methods for determining cost-effectiveness in 12VAC30-20-210.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Subsections A and B derived from VR460-01-69, eff. July 1, 1994; subsections C, D, and E derived from VR460-01-69.1, eff. July 1, 1994; subsections F, G and H derived from VR460-01-70, eff. July 1, 1994; amended, Virginia Register Volume 41, Issue 16, eff. May 8, 2025.

12VAC30-10-620 Use of contracts

The Medicaid agency has contracts of the type(s) listed in 42 CFR 434. All contracts meet the requirements of 42 CFR 434.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-71, eff. April 15, 1984.

12VAC30-10-630 (Repealed.)

Historical Notes

Derived from VR460-01-72, eff. October 15, 1979; repealed, Virginia Register Volume 12, Issue 2, eff. November 15, 1995.

12VAC30-10-631 Standards for payment for nursing facility and intermediate care facility for individuals with intellectual disabilities services

With respect to nursing facilities and intermediate care facilities for individuals with intellectual disabilities, all applicable requirements of 42 CFR Part 442, Subparts B and C are met.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 7, eff. January 16, 2002; amended, Virginia Register Volume 42, Issue 11, eff. February 11, 2026.

12VAC30-10-640 Program for licensing administrators of nursing homes

The state has a program that, except with respect to religious nonmedical health care institutions, meets the requirements of 42 CFR Part 431, Subpart N, for the licensing of nursing home administrators.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-01-73, eff. March 29, 1974; amended, Virginia Register Volume 18, Issue 7, eff. January 16, 2002.

12VAC30-10-650 Drug Utilization Review Program

A. 1. The Medicaid agency meets the requirements of § 1927(g) of the Social Security Act for a drug use review (DUR) program for outpatient drug claims.

2. The DUR program assures that prescriptions for outpatient drugs are:

a. Appropriate.

b. Medically necessary.

c. Are not likely to result in adverse medical results.

B. The DUR program is designed to educate physicians and pharmacists to identify and to reduce the frequency of patterns of fraud, abuse, gross overuse, or inappropriate or medically unnecessary care among physicians, pharmacists, and patients or associated with specific drugs as well as:

1. Potential and actual adverse drug reactions;

2. Therapeutic appropriateness;

3. Overutilization and underutilization;

4. Appropriate use of generic products;

5. Therapeutic duplication;

6. Drug disease contraindications;

7. Drug-drug interactions;

8. Incorrect drug dosage or duration of drug treatment;

9. Drug allergy interactions;

10. Clinical abuse or misuse; and

11. Provisions of § 1004 of the SUPPORT Act.

C. SUPPORT Act provisions.

1. Claim review limitations:

a. Prospective safety edits, including early, duplicate fill, and quantity limits for clinical appropriateness for opioids.

b. Maximum daily morphine milligram equivalents safety edits. A maximum dosing limit on opioids limits the daily morphine milliequivalents as recommended by clinical guidelines.

c. Concurrent utilization alerts. Prospective drug-to-drug interaction alerts will require a response from the pharmacy if an opioid and benzodiazepine or opioid and antipsychotics are being dispensed within an overlapping period with retrospective reviews performed on an ongoing periodic basis.

d. Comprehensive retrospective DUR is performed on opioid prescriptions on an ongoing periodic basis.

2. Programs to monitor antipsychotic medications to children. Antipsychotic agents are reviewed for age appropriateness, duplicate therapy, and adverse effects in children based on the U.S. Food and Drug Administration product approval and clinical guidelines.

3. Fraud and abuse identification. The Client Medical Management (CMM) program for fee-for-service (FFS) beneficiaries that may require restriction to physician, pharmacy, or both limiting the beneficiary's access to services identified as not medically necessary, excessive, or both. The beneficiary's designated physician is responsible for supervising, coordinating, and providing initial and primary medical care; initiating written referrals for specialist care; and maintaining the continuity of patient care.

D. The DUR program shall assess data use against predetermined standards whose source materials for their development are consistent with peer-reviewed medical literature that has been critically reviewed by unbiased independent experts and the following compendia:

1. American Hospital Formulary Service Drug Information (2003, as amended);

2. United States Pharmacopeia-Drug Information (2003, as amended);

3. MICROMEDEX (as updated monthly);

4. Drug Facts and Comparisons (as updated monthly); and

5. Drug Information Handbook (2003, as amended in 2004).

E. DUR is not required for drugs dispensed to residents of nursing facilities that are in compliance with drug regimen review procedures set forth in 42 CFR 483.60. The state has nevertheless chosen to include nursing home drugs in retrospective DUR.

F. 1. The DUR program includes prospective review of drug therapy at the point of sale or point of distribution before each prescription is filled or delivered to the Medicaid recipient.

2. Prospective DUR includes screening each prescription filled or delivered to an individual receiving benefits for potential drug therapy problems due to:

a. Therapeutic duplication;

b. Drug disease contraindications;

c. Drug-drug interactions;

d. Drug-interactions with nonprescription or over-the-counter drugs;

e. Incorrect dosage or duration of drug treatment;

f. Drug allergy interactions; and

g. Clinical abuse or misuse.

3. Prospective DUR includes counseling for Medicaid recipients based on standards established by State law and maintenance of patient profiles.

4. Prospective DUR may also include electronic messages as well as rejection of claims at point-of-sale pending appropriate designated interventions by the dispensing pharmacist or prescribing physician.

5. Designated interventions may include provider override, obtaining prior authorization via communication to a call center staffed with appropriate clinicians, or written communication to prescribers.

G. 1. The DUR program includes retrospective DUR through its mechanized drug claims processing and information retrieval system or otherwise that undertakes ongoing periodic examination of claims data and other records to identify:

a. Patterns of fraud and abuse;

b. Gross overuse; and

c. Inappropriate or medically unnecessary care among physicians, pharmacists, Medicaid recipients, or associated with specific drugs or groups of drugs.

2. The DUR program assesses data on drug use against explicit predetermined standards, including monitoring for:

a. Therapeutic appropriateness;

b. Overutilization and underutilization;

c. Appropriate use of generic products;

d. Therapeutic duplication;

e. Drug disease contraindications;

f. Drug-to-drug interactions;

g. Incorrect dosage or duration of drug treatment; and

h. Clinical abuse or misuse.

3. The DUR program through its state DUR Board, using data provided by the board, provides for active and ongoing educational outreach programs to educate practitioners and pharmacists on common drug therapy problems to improve prescribing and dispensing practices.

4. In situations of conflict with these criteria, DMAS, pursuant to the DUR Board's criteria and requirements, shall reject or deny presented claims and require the dispensing pharmacist to intervene as specified through electronic messages in the point-of-sale system before the claim will be approved for payment.

5. Designated interventions may include provider override, obtaining prior authorization via communication to a call center staffed with appropriate clinicians, or written communication to prescribers.

H. 1. The DUR program has established a state DUR Board directly.

2. The DUR Board membership includes health professionals (one-third licensed actively practicing pharmacists and one-third but no more than 51% licensed and actively practicing physicians) with knowledge and experience in one or more of the following:

a. Clinically appropriate prescribing of covered outpatient drugs.

b. Clinically appropriate dispensing and monitoring of covered outpatient drugs.

c. Drug use review, evaluation, and intervention.

d. Medical quality assurance.

3. The activities of the DUR Board include:

a. Prospective DUR;

b. Retrospective DUR;

c. Application of Standards as defined in § 1927(g)(2)(C); and

d. Ongoing interventions for physicians and pharmacists targeted toward therapy problems or individuals identified in the course of retrospective DUR.

4. The interventions include in appropriate instances:

a. Information dissemination.

b. Written, oral, and electronic reminders.

c. Face-to-Face and telephonic discussions.

d. Intensified monitoring or review of prescribers or dispensers.

e. Rejected or denied claims, as appropriate, to prevent the violation of the DUR Board's predetermined criteria.

Provider override, obtaining prior authorization via communication to a call center staffed with appropriate clinicians, or written communication to prescribers.

I. The state assures that it will prepare and submit an annual report to the secretary, which incorporates a report from the state DUR Board, and that the state will adhere to the plans, steps, procedures as described in the report.

The Medicaid agency ensures that predetermined criteria and standards have been recommended by the DUR Board and approved by either Board of Medical Assistance Services (BMAS) or the director, acting on behalf of the BMAS, pursuant to § 32.1-324 of the Code of Virginia and that they are based upon documentary evidence of the DUR Board. The activities of the DUR Board and the Medicaid fraud control programs are and shall be maintained as separate. The DUR Board shall refer suspected cases of fraud or abuse to the appropriate fraud and abuse control unit with the Medicaid agency.

J. 1. The state establishes, as its principal means of processing claims for covered outpatient drugs under this title, a point-of-sale electronic claims management system to perform on-line:

a. Real time eligibility verification.

b. Claims data capture.

c. Adjudication of claims. Such adjudication may include the rejection or denial of claims found to be in conflict with DUR criteria. Should such rejection or denial occur during the adjudication process, the dispensing pharmacist shall have the opportunity to resolve the conflict and resubmit the claim for readjudication.

d. Assistance to pharmacists, etc., applying for and receiving payment.

2. Prospective DUR is performed using an electronic point of sale drug claims processing system.

K. Hospitals which dispense covered outpatient drugs are exempted pursuant to federal law from the drug utilization review requirements of this section when facilities use drug formulary systems and bill the Medicaid program no more than the hospital's purchasing cost for such covered outpatient drugs.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1315 and 42 USC § 1396 et seq.
• Historical Notes: Subsections A, B, and C derived from VR460-01-74, eff. June 16, 1993; subsections D, E, and F 1 derived from VR460-01-74.1, eff. June 16, 1993; subsections F 2 through G 3 derived from VR460-01-74.2, eff. June 16, 1993; subsections G 4 and H, I, and J derived from VR460-01-74.3, eff. June 16, 1993; amended, Virginia Register Volume 21, Issue 6, eff. January 3, 2005; Volume 37, Issue 24, eff. September 2, 2021.

12VAC30-10-660 Disclosure of survey information and provider or contractor evaluation

The Medicaid agency has established procedures for disclosing pertinent findings obtained from surveys and provider and contractor evaluations that meet all the requirements in 42 CFR 431.115.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-75, eff. October 15, 1979.

12VAC30-10-670 Appeals process

A. The Medicaid agency has established appeals procedures for NFs as specified in 42 CFR 431.153 and 431.154.

B. The state provides an appeals system that meets the requirements of Subpart E of 42 CFR Part 431, 42 CFR 483.15, Subpart E of 42 CFR Part 483, and 12VAC30-110-10 through 12VAC30-110-370 for residents who wish to appeal a notice of intent to transfer or discharge from a NF and for individuals adversely affected by the preadmission screening or annual resident review requirements of Subpart C of 42 CFR Part 483.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-01-76, eff. June 1, 1993; amended, Virginia Register Volume 34, Issue 1, eff. October 19, 2017.

12VAC30-10-680 Conflict of interest provisions

The Medicaid agency meets the requirements of § 1902(a)(4)(C) of the Act concerning the prohibition against acts, with respect to any activity under the plan, that are prohibited by § 207 or § 208 of Title 18, United States Code.

The Medicaid agency meets the requirements of § 1902(a)(4)(D) of the act concerning the safeguards against conflicts of interest that are at least as stringent as the safeguards that apply under § 27 of the Office of Federal Procurement Policy Act (41 USC § 423).

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-01-77, eff. June 30, 1979; amended, Virginia Register Volume 15, Issue 26, eff. October 13, 1999.

12VAC30-10-690 Exclusion of providers and suspension of practitioners and other individuals

A. All of the requirements of 42 CFR 1002, Subpart B are met.

In addition to meeting all federal requirements, the agency, under the authority of state law, imposes broader sanctions.

B. The Medicaid agency meets the requirements of:

1. § 1902(p) of the Act by excluding from participation:

a. At the state's discretion, any individual or entity for any reason for which the Secretary could exclude the individual or entity from participation in a program under Title XVIII in accordance with § 1128, 1128A, or 1866(b)(2).

b. Any HMO (as defined in § 1903(m) of the Act) or an entity furnishing services under a waiver approved under § 1915(b)(1) of the Act, that:

(1) Could be excluded under § 1128(b)(8) relating to owners and managing employees who have been convicted of certain crimes or received other sanctions; or

(2) Has, directly or indirectly, a substantial contractual relationship (as defined by the Secretary) with an individual or entity that is described in § 1128(b)(8)(B) of the Act.

2. An MCO, PIHP, PAHP, or PCCM may not have prohibited affiliations with individuals (as defined in 42 CFR 438.610(b)) who are debarred, suspended, or otherwise excluded from participating in procurement activities under the Federal Acquisition Regulation or from participating in nonprocurement activities under regulations issued under Executive Order No. 12549 or under guidelines implementing Executive Order No. 12549. If the Commonwealth finds that an MCO, PCCM, PIHP, or PAHP is not in compliance, the Commonwealth will comply with the requirements of 42 CFR 438.610(c).

3. § 1902(a)(39) of the Act by:

a. Excluding an individual or entity from participation for the period specified by the Secretary, when required by the Secretary to do so in accordance with § 1128 or 1128A of the Act; and

b. Providing that no payment will be made with respect to any item or service furnished by an individual or entity during this period.

C. The Medicaid agency meets the requirements of:

1. § 1902(a)(41) of the Act with respect to prompt notification to HCFA whenever a provider is terminated, suspended, sanctioned, or otherwise excluded from participating under this state plan; and

2. § 1902(a)(49) of the Act with respect to providing information and access to information regarding sanctions taken against health care practitioners and providers by state licensing authorities in accordance with § 1921 of the Act.

D. Provider terminations or exclusions shall be in accordance with § 32.1-325 D and E of the Code of Virginia.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; Title XIX of the Social Security Act (42 USC § 1396 et seq.).
• Historical Notes: Subsection A derived from VR460-01-78, eff. June 30, 1979; subsection B 1 derived from VR460-01-78.1, eff. January 1, 1988; subsections B 2 [now 3] and C derived from VR460-01-78.2, eff. January 1, 1988; amended, Virginia Register Volume 25, Issue 26, eff. October 1, 2009; Volume 26, Issue 19, eff. July 1, 2010.

12VAC30-10-700 Disclosure of information by providers and fiscal agents

The Medicaid agency has established procedures for the disclosure of information by providers and fiscal agents as specified in 42 CFR 455.104 through 455.106 and sections 1128(b)(9) and 1902(a)(38) of the Act.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-79, eff. January 1, 1988.

12VAC30-10-710 Income and eligibility verification system

A. The Medicaid agency has established a system for income and eligibility verification in accordance with the requirements of 42 CFR 435.940 through 435.960.

B. 12VAC30-20-220 describes, in accordance with 42 CFR 435.958(a)(6), the information that will be requested in order to verify eligibility or the correct payment amount and the agencies and the state or states from which that information will be requested.

C. The Commonwealth has an eligibility determination system that provides for data matching through the Public Assistance Reporting Information System (PARIS), or any successor system, including matching with medical assistance programs operated by other states. The information that is requested will be exchanged with states and other entities legally entitled to verify Title XIX applicants and individuals eligible for covered Title XIX services consistent with applicable PARIS agreements.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-01-79, eff. January 1, 1988; amended, Virginia Register Volume 29, Issue 14, eff. April 10, 2013.

12VAC30-10-720 Medicaid eligibility cards for homeless individuals

A. The Medicaid agency has a method for making cards evidencing eligibility for medical assistance available to an individual eligible under the State's approved plan who does not reside in a permanent dwelling or does not have a fixed home or mailing address.

B. 12VAC30-20-230 specifies the method for issuance of Medicaid eligibility cards to homeless individuals.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-79.1, eff. January 1, 1988.

12VAC30-10-730 Systematic alien verification for entitlements

The State Medicaid agency has established procedures for the verification of alien status through the Immigration & Naturalization Service (INS) designated system, Systematic Alien Verification for Entitlements (SAVE), effective October 1, 1988.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-79.2, eff. January 1, 1989.

12VAC30-10-740 (Repealed.)

Historical Notes

Subsections A through E derived from VR460-01-79.3, eff. October 1, 1990; subsections F, G, and H derived from VR460-01-79.4, eff. October 1, 1990; subsections I and J derived from VR460-01-79.5, eff. October 1, 1990; repealed, Virginia Register Volume 12, Issue 2, eff. November 15, 1995.

12VAC30-10-750 (Repealed.)

Historical Notes

Derived from VR460-01-79.6, eff. July 4, 1990; repealed, Virginia Register Volume 12, Issue 25, eff. October 2, 1996.

12VAC30-10-751 Enforcement of compliance for nursing facilities

A. The Commonwealth shall comply with the Medicaid Program requirements of Subpart E of 42 CFR Part 488.

B. Notification of enforcement remedies. When taking an enforcement action against a nonstate operated nursing facility, the state provides notification in accordance with 42 CFR 488.402(f).

1. The notice (except for civil money penalties and state monitoring) specifies:

a. The nature of noncompliance;

b. Which remedy is imposed;

c. The effective date of the remedy; and

d. The right to appeal the determination leading to the remedy.

2. The notice for civil money penalties is in writing and contains the information specified in 42 CFR 488.434 and 42 CFR 488.440.

3. Except for civil money penalties and state monitoring, notice is given at least two calendar days before the effective date of the enforcement remedy for immediate jeopardy situations and at least 15 calendar days before the effective date of the enforcement remedy when immediate jeopardy does not exist. The two-day and 15-day notice periods begin when the facility receives the notice, but, in no event will the effective date of the enforcement action be later than 20 calendar days after the notice is sent. (42 CFR 488.402(f)(3),(4), and (5))

4. Notification of termination is given to the facility and to the public at least two calendar days before the remedy's effective date if the noncompliance constitutes immediate jeopardy and at least 15 calendar days before the remedy's effective date if the noncompliance does not constitute immediate jeopardy. The state must terminate the provider agreement of a nursing facility in accordance with procedures in 42 CFR Parts 431 and 442. (42 CFR 488.456(c) and (d))

C. Factors to be considered in selecting remedies. In determining the seriousness of deficiencies, the state considers the factors specified in 42 CFR 488.404(b)(1) and (2).

D. Application of remedies.

1. If there is immediate jeopardy to resident health or safety, the state terminates the nursing facility's provider agreement within 23 calendar days from the date of the last survey or immediately imposes temporary management to remove the threat within 23 days. (42 CFR 488.410)

2. The state imposes the denial of payment (or its approved alternative) with respect to any newly admitted individual to a nursing facility that has not come into substantial compliance within three months after the last day of the survey. (42 CFR 488.417(b)(1) and § 1919(h)(2)(C) of the Act)

3. The state imposes the denial of payment for new admissions remedy as specified in 42 CFR 488.417 (or its approved alternative) and a state monitor as specified at 42 CFR 488.422, when a facility has been found to have provided substandard quality of care on the last three consecutive standard surveys. (42 CFR 488.414 and § 1919(h)(2)(D) of the Act)

4. The state follows the criteria specified at 42 CFR 488.408(c)(2), (d)(2), and (e)(2) when it imposes remedies in place of or in addition to termination. (42 CFR 488.408(b) and § 1919(h)(2)(A) of the Act)

5. When immediate jeopardy does not exist, the state terminates a nursing facility's provider agreement no later than six months from the finding of noncompliance if the conditions of 42 CFR 488.412(a) are not met.

E. Available remedies. The state has established the remedies defined in 42 CFR 488.406(b). 12VAC30-20-251 through 12VAC30-20-259 describe the criteria for applying the remedies, plan of correction, nursing facility appeals, and repeated substandard quality of care.

F. In the event that the Commonwealth and CMS disagree on findings of noncompliance or application of remedies in a nonstate operated nursing facility or a dually participating facility when there is no immediate jeopardy, such disagreement shall be resolved in accordance with the provisions of 42 CFR 488.452.

G. The Commonwealth shall have the authority to apply one or more remedies for each deficiency constituting noncompliance or for all deficiencies constituting noncompliance.

H. As set forth by 42 CFR 488.454, remedies shall terminate on the date that CMS or the Commonwealth can verify as the date that substantial compliance was achieved and the facility has demonstrated that it could maintain substantial compliance once the facility supplies documentation acceptable to CMS or the Commonwealth that it was in substantial compliance and was capable of remaining in compliance.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 25, eff. October 2, 1996; amended, Virginia Register Volume 34, Issue 1, eff. October 19, 2017.

12VAC30-10-760 Pharmacy services rebate agreement terms

The Commonwealth conforms to § 1927(b) (2) with regard to the reporting of information on the total number of dosage units of each covered outpatient drug dispensed under the plan during the quarter, and in such a manner as specified by the Secretary of HHS and also shall promptly transmit a copy of such report to the Secretary. The Commonwealth also conforms to § 1927(b) (3) (D) with regard to assuring the confidentiality of the disclosure of the identity of a manufacturer or wholesaler and prices charged for drugs by such manufacturer or wholesaler.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-79.7, eff. April 1, 1993.

12VAC30-10-770 Required coordination between the Medicaid and WIC Programs

The Medicaid agency provides for the coordination between the Medicaid program and the Special Supplemental Food Program for Women, Infants, and Children (WIC) and provides timely notice and referral to WIC in accordance with § 1902(a)(53) of the Act.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-79.8, eff. June 16, 1993.

12VAC30-10-780 Nurse aide training and competency evaluation for nursing facilities

A. The State assures that the requirements of 42 CFR 483.150(a), which relate to individuals deemed to meet the nurse aide training and competency evaluation requirements, are met.

B. The State does not elect to waive the competency evaluation requirements for individuals who meet the requirements of 42 CFR 483.150(b)(1).

C. The State does not elect to deem individuals who meet the requirements of 42 CFR 483.150(b)(2) to have met the nurse aide training and competency evaluation requirements.

D. The State specifies any nurse aide training and competency evaluation programs it approves as meeting the requirements of 42 CFR 483.152 and competency evaluation programs it approves as meeting the requirements of 42 CFR 483.154.

E. The State offers a nurse aide training and competency evaluation program that meets the requirements of 42 CFR 483.152.

F. The State offers a nurse aide competency evaluation program that meets the requirements of 42 CFR 483.154.

G. If the State does not choose to offer a nurse aide training and competency evaluation program or nurse aide competency evaluation program, the State reviews all nurse aide training and competency evaluation programs and competency evaluation programs upon request.

H. The State survey agency determines, during the course of all surveys, whether the requirements of 483.75(e) are met.

I. Before approving a nurse aide training and competency evaluation program, the State determines whether the requirements of 42 CFR 483.152 are met.

J. Before approving a nurse aide competency evaluation program, the State determines whether the requirements of 42 CFR 483.154 are met.

K. For program reviews other than the initial review, the State visits the entity providing the program.

L. The State does not approve a nurse aide training and competency evaluation program or competency evaluation program offered by or in certain facilities as described in 42 CFR 483.151(b)(2) and (3).

M. The State, within 90 days of receiving a request for approval of a nurse aide training and competency evaluation program or competency evaluation program, either advises the requestor whether or not the program has been approved or requests additional information from the requestor.

N. The State does not grant approval of a nurse aide training and competency evaluation program for a period longer than 2 years.

O. The State reviews programs when notified of substantive changes (e.g., extensive curriculum modification).

P. The State withdraws approval from nurse aide training and competency evaluation programs and competency evaluation programs when the program is described in 42 CFR 483.151(b)(2) or (3).

Q. The State withdraws approval of nurse aide training and competency evaluation programs that cease to meet the requirements of 42 CFR 483.152 and competency evaluation programs that cease to meet the requirements of 42 CFR 483.154.

R. The State withdraws approval of nurse aide training and competency evaluation programs and competency evaluation programs that do not permit unannounced visits by the State.

S. When the State withdraws approval from a nurse aide training and competency evaluation program or competency evaluation program, the State notifies the program in writing, indicating the reasons for withdrawal of approval.

T. The State permits students who have started a training and competency evaluation program from which approval is withdrawn to finish the program.

U. The State provides for the reimbursement of costs incurred in completing a nurse aide training and competency evaluation program or competency evaluation program for nurse aides who become employed by or who obtain an offer of employment from a facility within 12 months of completing such program.

V. The State provides advance notice that a record of successful completion of competency evaluation will be included in the State's nurse aide registry.

W. Competency evaluation programs are administered by the State or by a State-approved entity which is neither a skilled nursing facility participating in Medicare nor a nursing facility participating in Medicaid.

X. The State does not elect to permit proctoring of the competency evaluation in accordance with 42 CFR 483.154(d).

Y. The State has a standard for successful completion of competency evaluation programs.

Z. The State includes a record of successful completion of a competency evaluation within 30 days of the date an individual is found competent.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Subsections A through F derived from VR460-01-79.14, eff. June 16, 1993; subsections G through L derived from VR460-01-79.15, eff. June 16, 1993; subsections M through R derived from VR460-01-79.16, eff. June 16, 1993; subsections S through Y derived from VR460-01-79.17, eff. June 16, 1993; subsection Z derived from VR460-01-79.18, eff. June 16, 1993.

12VAC30-10-790 Preadmission screening and annual resident review in nursing facilities

A. The Medicaid agency has in effect a written agreement with the state mental health and intellectual disability authorities that meet the requirements of 42 CFR 431.621(c).

B. The state operates a preadmission screening and annual resident review program that meets the requirements of 42 CFR 483.100-138.

C. The state does not claim as "medical assistance under the State Plan" the cost of services to individuals who should receive preadmission screening or annual resident review until such individuals are screened or reviewed.

D. With the exception of NF services furnished to certain NF residents defined in 42 CFR 483.118(c)(1), the state does not claim as "medical assistance under the State Plan" the cost of NF services to individuals who are found not to require NF services.

E. 12VAC30-20-260 specifies the state's definition of specialized services.

F. Except for residents identified in 42 CFR 483.118(c)(1), the state mental health authority makes categorical determinations that individuals with certain mental conditions or levels of severity of mental illness would normally require specialized services of such an intensity that a specialized services program could not be delivered by the state in most, if not all, NFs and that a more appropriate placement should be utilized.

G. The state describes an categorical determinations it applies in 12VAC30-20-270.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Subsections A through E derived from VR460-01-79.19, eff. June 1, 1993; subsections F and G derived from VR460-01-79.20, eff. June 1, 1993; amended, Virginia Register Volume 42, Issue 11, eff. February 11, 2026.

12VAC30-10-800 Survey and certification process

A. The state assures that the requirements of § 1919(a)(1)(A) through (C) and § 1919(g)(2)(A) through (E)(iii) of the Act which relate to the survey and certification of non-state owned facilities based on the requirements of § 1919(b), (c) and (d) of the Act, are met.

B. The state conducts periodic education programs for staff and residents (and their representatives). 12VAC30-20-272 describes the survey and certification educational program.

C. The state provides for a process for the receipt and timely review and investigation of allegations of neglect and abuse and misappropriation of resident property by a nurse aide of a resident in a nursing facility or by another individual used by the facility. 12VAC30-20-274 describes the state's process.

D. The state agency responsible for surveys and certification of nursing facilities conducts the process for the receipt and timely review and investigation of allegations of neglect and abuse and misappropriation of resident property.

E. The state assures that a nurse aide, found to have neglected or abused a resident or misappropriated resident property in a facility, is notified of the finding. The name and finding is placed on the nurse aide registry.

F. The state notifies the appropriate licensure authority of any licensed individual found to have neglected or abused a resident or misappropriated resident property in a facility.

G. The state has procedures, as provided for at § 1919(g)(2)(A)(i), for the scheduling and conduct of standard surveys to assure that the state has taken all reasonable steps to avoid giving notice through the scheduling procedures and the conduct of the surveys themselves. 12VAC30-20-275 describes the state's procedures.

H. The state assures that each facility shall have a standard survey which includes (for a case-mix stratified sample of residents) a survey of the quality of care furnished, as measured by indicators of medical, nursing and rehabilitative care, dietary and nutritional services, activities and social participation, and sanitation, infection control, and the physical environment, written plans of care and audit of resident's assessments, and a review of the compliance with resident's rights not later than 15 months after the date of the previous standard survey.

I. The state assures that the statewide average interval between standard surveys of nursing facilities does not exceed 12 months.

J. The state may conduct a special standard or special abbreviated standard survey within two months of any change of ownership, administration, management, or director of nursing of the nursing facility to determine whether the change has resulted in any decline in the quality of care furnished by the facility.

K. The state conducts extended surveys immediately or, if not practicable, not later than two weeks following a completed standard survey in a nursing facility which is found to have provided substandard care or in any other facility at the secretary's or state's discretion.

L. The state conducts standard and extended surveys based upon a protocol, i.e., survey forms, methods, procedures and guidelines developed by HCFA, using individuals in the survey team who meet minimum qualifications established by the secretary.

M. The state provides for programs to measure and reduce inconsistency in the application of survey results among surveyors. 12VAC30-20-277 describes the state's programs.

N. The state issues a multidisciplinary team of professionals including a registered professional nurse.

O. The state assures that members of a survey team do not serve (or have not served within the previous two years) as a member of the staff or consultant to the nursing facility or has no personal or familial financial interest in the facility being surveyed.

P. The state assures that no individual shall serve as a member of any survey team unless the individual has successfully completed a training and test program in survey and certification techniques approved by the secretary.

Q. The state maintains procedures and adequate staff to investigate complaints of violations of requirements by nursing facilities and onsite monitoring. 12VAC30-20-278 describes the state's complaint procedures.

R. The state makes available to the public information respecting surveys and certification of nursing facilities including statements of deficiencies, plans of correction, copies of cost reports, statements of ownership and the information disclosed under § 1126 of the Act.

S. The state notifies the state long-term care ombudsman of the state's finding of noncompliance with any the requirements of subsection B, C, and D or of any adverse actions taken against a nursing facility.

T. If the state finds substandard quality of care in a facility, the state notifies the attending physician of each resident with respect to which such finding is made and the nursing facility administrator licensing board.

U. The state provides the state Medicaid fraud and abuse agency access to all information concerning survey and certification actions.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; §§ 1919(g)(1) through (2) and 1919(g)(4) through (5) of the Act, P.L. 100-203 (§ 4212(a)).
• Historical Notes: Derived from VR460-01-79.21, eff. November 15, 1995.

12VAC30-10-810 Resident assessment for nursing facilities

A. The state specifies the instrument to be used by nursing facilities for conducting a comprehensive, accurate, standardized, reproducible assessment of each resident's functional capacity as required in § 1919(b)(3)(A) of the Act.

B. The state is using the resident assessment instrument designated by CMS (Appendix R "Resident Assessment Instrument for Long-Term Care Facilities" of the CMS State Operations Manual).

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-01-79.24, eff. November 15, 1995; amended, Virginia Register Volume 34, Issue 1, eff. October 19, 2017.

12VAC30-10-815 Cooperation with Medicaid Integrity Program efforts

The Medicaid agency assures it complies with such requirements determined by the Secretary to be necessary for carrying out the Medicaid Integrity Program established under § 1936 of the Act.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 4, eff. November 26, 2008.

12VAC30-10-820 Employee education about false claims recoveries

A. Definitions. The following words and terms when used in this part shall have the following meanings unless the context clearly indicates otherwise:

"Contractor" or "agent" includes any contractor, subcontractor, agent, or other person that or who, on behalf of the entity, furnishes, or otherwise authorizes the furnishing of, Medicaid health care items or services, performs billing or coding functions, or is involved in the monitoring of health care provided by the entity.

"Employee" means any officer or employee of the entity.

"Entity" means a governmental agency, organization, unit, corporation, partnership, or other business arrangement (including any Medicaid managed care organization, irrespective of the form of business structure or arrangement by which it exists), whether for-profit or not-for-profit, which receives or makes payments, under a state plan approved under title XIX or under any waiver of such plan, totaling at least $5,000,000 annually. A governmental component providing Medicaid health care items or services for which Medicaid payments are made would qualify as an "entity" (e.g., a state mental health facility or school district providing school-based health services). A government agency that merely administers the Medicaid program, in whole or part (e.g., managing the claims processing system or determining beneficiary eligibility), is not, for these purposes, considered to be an entity.

B. The Medicaid agency meets the requirements regarding establishment of policies and procedures for the education of employees of entities covered by § 1902(a)(68) of the Social Security Act (the Act) regarding false claims recoveries and methodologies for oversight of entities' compliance with these requirements.

C. Provider requirements.

1. If an entity furnishes items or services at more than a single location or under more than one contractual or other payment arrangement, the provisions of § 1902(a)(68) of the Act apply if the aggregate payments to that entity meet the $5,000,000 annual threshold. This applies whether the entity submits claims for payments using one or more provider identification or tax identification numbers.

2. An entity will have met the $5,000,000 annual threshold as of January 1, 2007, if it received or made payments in that amount in federal fiscal year 2006. Future determinations regarding an entity's responsibility stemming from the requirements of § 1902(a)(68) of the Act will be made by January 1 of each subsequent year based upon the amount of payments an entity either received or made under the state plan during the preceding federal fiscal year.

3. The entity must establish and disseminate written policies that must also be adopted by its contractors or agents. Written policies may be on paper or in electronic form, but must be readily available to all employees, contractors, or agents. The entity need not create an employee handbook if none already exists.

4. An entity shall establish written policies for all employees (including management), and of any contractor or agent of the entity, that include detailed information about the False Claims Act and the other provisions named in § 1902(a)(68)(A) of the Act, including the Virginia Fraud Against Taxpayers Act (§ 8.01-216.1 et seq. of the Code of Virginia). The entity shall include in those written policies detailed information about the entity's policies and procedures for detecting and preventing waste, fraud, and abuse. The entity shall also include in any employee handbook a specific discussion of the laws described in the written policies, the rights of employees to be protected as whistleblowers and a specific discussion of the entity's policies and procedures for detecting and preventing fraud, waste, and abuse.

D. 12VAC30-20-275 describes, in accordance with § 1902(a)(68) of the Act, the methodology of compliance oversight and the frequency with which the Commonwealth will reassess compliance on an ongoing basis.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 2, eff. October 31, 2007.

Part V Personnel Administration

12VAC30-10-850 Standards of personnel administration

A. The Medicaid agency has established and will maintain methods of personnel administration in conformity with standards prescribed by the U.S. Civil Service Commission in accordance with § 208 of the Intergovernmental Personnel Act of 1970 and the regulations on Administration of the Standards for a Merit System of Personnel Administration, 5 CFR 900, Subpart F. All requirements of 42 CFR 432.10 are met.

B. Affirmative Action Plan. The Medicaid agency has in effect an affirmative action plan for equal employment opportunity that includes specific action steps and timetables and meets all other requirements of 5 CFR 900, Subpart F.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-80, eff. October 1, 1977.

12VAC30-10-860 [Reserved]. (Reserved)

12VAC30-10-870 Training programs; subprofessional and volunteer programs

The Medicaid agency meets the requirements of 42 CFR 432, Subpart B, with respect to a training program for agency personnel and the training and use of subprofessional staff and volunteers.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-82, eff. February 28, 1978.

12VAC30-10-880 [Reserved]. (Reserved)

Part VI Financial Administration

12VAC30-10-900 Fiscal policies and administration

The Medicaid agency and, where applicable, local agencies administering the plan, maintains an accounting system and supporting fiscal records adequate to assure that claims for Federal funds are in accord with applicable Federal requirements. The requirements of 42 CFR 433.32 are met.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-83, eff. September 30, 1976.

12VAC30-10-910 Cost allocation

There is an approved cost allocation plan on file with the Department in accordance with the requirements contained in 45 CFR 95, Subpart E.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-84, eff. October 1, 1982.

12VAC30-10-920 State financial participation

A. State funds are used in both assistance and administration.

There is local participation. State funds are used to pay not less than 40 percent of the non-Federal share of the total expenditures under the plan. There is a method of apportioning Federal and State funds among the political subdivisions of the State on an equalization or other basis which assures that lack of adequate funds from local sources will not result in lowering the amount, duration, scope, or quality of care and services or level of administration under the plan in any part of the State.

B. State and Federal funds are apportioned among the political subdivisions of the State on a basis consistent with equitable treatment of individuals in similar circumstances throughout the State.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-85, eff. February 15, 1990.

12VAC30-10-930 Hospital credit balance reporting

Hospitals shall be required to report Medicaid credit balances on a quarterly basis no later than 30 days after the close of each quarter. For a credit balance arising on a Medicaid claim within three years of the date paid by the DMAS, the hospital shall either submit a check for the balance due or an adjustment claim with the Credit Balance Report. For credit balances arising on claims over three years old, the hospital shall submit a check for the balance due. Interest at the maximum rate allowed shall be assessed for those credit balances (overpayments) that are identified on the quarterly report but not reimbursed with the submission of the form. Interest will begin to accrue 30 days after the end of the quarter and will continue to accrue until the overpayment has been refunded or adjusted. A penalty shall be imposed for failure to submit the form timely as follows:

1. Hospitals that have not submitted their Medicaid credit balance data within the required 30 days after the end of a quarter shall be notified in writing. If the required report is not submitted within the next 30 days, there will be a 20% reduction in the DMAS payment.

2. If the required report is not submitted within the next 30 days (60 days after the due date), the DMAS payments shall be reduced to -0- until the report is received.

3. If the credit balance has not been refunded within 90 days of the end of a quarter, it shall be recovered, with interest, through the use of a negative balance transaction on the weekly remittance.

4. A periodic audit shall be conducted of hospitals' quarterly submission of Medicaid credit balance data. Hospitals shall maintain an audit trail back to the underlying accounts receivable records supporting each quarterly report.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-01-85.1, eff. October 1, 1994; amended, Virginia Register Volume 25, Issue 14, eff. April 15, 2009.

12VAC30-10-940 [Reserved]. (Reserved)

Part VII General Provisions

12VAC30-10-960 Plan amendments

The plan will be amended whenever necessary to reflect new or revised Federal statutes or regulations or material change in State law, organization, policy or State agency operation.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-86, eff. June 16, 1993.

12VAC30-10-970 Nondiscrimination

In accordance with Title VI of the Civil Rights Act of 1964 (42 USC 2000d et. seq.), § 504 of the Rehabilitation Act of 1973 (29 USC 70b), and the regulations at 45 CFR 80 and 84, the Medicaid agency assures that no individual shall be subjected to discrimination under this plan on the grounds of race, color, national origin, or handicap.

The Medicaid agency has methods of administration to assure that each program or activity for which it receives Federal financial assistance will be operated in accordance with Title VI regulations. These methods for Title VI are described in 12VAC30-20-280.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-01-87, eff. June 16, 1993.

12VAC30-10-980 (Repealed.)

Historical Notes

Derived from VR460-01-88, eff. June 16, 1993; repealed, Virginia Register Volume 12, Issue 2, eff. November 15, 1995.

12VAC30-10-990 State Governor's review

The Office of the Governor does not wish to review amendments, long-range program planning projections, and other periodic reports thereon, excluding periodic statistical, budget and fiscal reports and has designated the Secretary of Health and Human Resources to review Plan amendment material per Executive Order 31 (94).

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 CFR 430.12(b).
• Historical Notes: Derived from VR460-01-89, eff. June 16, 1993; amended, Virginia Register Volume 12, Issue 2, eff. November 15, 1995.

12VAC30-10-1000 General provider appeals

These provisions shall apply to all provider types for informal and formal administrative appeals.

12VAC30-20-500 (Attachment 7.5) describes the process, procedures, and time frames for all provider informal and formal administrative appeals.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 19, eff. July 4, 2001.

Chapter 20 Administration of Medical Assistance Services

Part I Miscellaneous Provisions

12VAC30-20-10 Attorney General's certification

I certify that The Department of Medical Assistance Services is the single state agency responsible for: administering the plan.

The legal authority under which the agency administers the plan on a Statewide basis is Title 32.1, Chapter 10 Section 32.1-325, Code of Virginia (1950) as amended.

Date: Feb 14, 1985

Signature: /s/Gerald L. Baliles, Attorney General

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-1.1100, eff. March 1, 1985.

12VAC30-20-20 (Repealed.)

Historical Notes

Derived from VR460-02-1.2100 through VR460-02-1.2400, eff. March 1, 1985; repealed, Virginia Register Volume 12, Issue 2, eff. November 15, 1995.

12VAC30-20-60 Definition of Medicaid state plan health maintenance organizations (HMOs)

A. Definitions. A Virginia Medicaid qualifying health maintenance organization (HMO) is defined as an entity which has a license to operate as a health maintenance organization issued by the Bureau of Insurance of the State Corporation Commission.

B. Incorporation by reference. The Bureau of Insurance of the State Corporation Commission, through Insurance Regulation No. 28, Rules Governing Health Maintenance Organizations, effective September 1, 1987, provides licensing only to health maintenance organizations meeting the requirements of 43 CFR 434.20(c). The Department of Medical Assistance Services hereby incorporates by reference Insurance Regulation No. 28.

C. Organization and description. Virginia Medicaid qualifying health maintenance organizations shall be primarily organized for the purpose of providing health care services. As provided for in Regulation 28, a health maintenance organization is an organization which undertakes to provide or arrange for one or more health care plans. A health care plan is any arrangement in which any health maintenance organization undertakes to provide, arrange for, pay for, or reimburse any part of the cost of any health care services.

D. Accessibility of services. Virginia Medicaid qualifying health maintenance organizations shall make the services they provide as accessible to Medicaid enrollees as those services are available to non-enrolled Medicaid recipients within the area served by the Virginia Medicaid qualifying health maintenance organization. As provided for in Regulation 28, all Virginia Medicaid qualifying health maintenance organizations must establish and maintain arrangements satisfactory to the Medicaid Agency to assure both availability and accessibility of personnel and facilities providing health care services including:

1. Reasonable hours of operation and after-hours emergency health care,

2. Reasonable proximity to enrollees within the service area, so as not to result in unreasonable barriers to accessibility,

3. Sufficient personnel, including health professionals, administrators, and support staff, to reasonably assure that all services contracted for will be accessible to enrollees on an appropriate basis without delays detrimental to the health of the enrollee, and

4. Adequate arrangements to provide inpatient hospital services for basic health care.

E. Financial requirements. Regulation 28 provides controls limiting the risk of insolvency of Virginia Medicaid qualifying health maintenance organizations, and assuring that Medicaid enrollees will not be liable for any Virginia Medicaid qualifying health maintenance organization's debts should it become insolvent. Specifically, Regulation 28 sets forth the requirements for a Virginia Medicaid qualifying health maintenance organization's minimum net worth, deposits with the State Treasurer, mandated liability insurance, enrollee hold harmless provisions in subcontracts, and accounting and reporting responsibilities.

F. The Medicaid Agency shall, through the terms and conditions of risk contracts with Virginia Medicaid qualifying health maintenance organizations, make provisions for meeting the additional requirements provided for in 42 CFR 434.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-02-2.1100, eff. July 1, 1995.

12VAC30-20-70 (Repealed.)

Historical Notes

Derived from VR460-02-2.8100, eff. December 18, 1991; repealed, Virginia Register Volume 11, Issue 24, eff. September 21, 1995.

12VAC30-20-80 Coordination of Title XIX with Part A and Part B of Title XVIII

The following method is used to provide benefits under Part A and Part B of Title XVIII to the groups of Medicare-eligible individuals indicated:

A. Part B buy-in agreements with the Secretary of HHS. This agreement covers:

1. All individuals eligible under the state's approved Title XIX plan except qualified disabled working individuals.

2. Qualified Medicare beneficiaries provided by § 301 of P.L. 100-360 as amended by § 8434 of P.L. 100-647.

3. Specified low-income Medicare beneficiary (SLMB) provided by § 1905(p) of the Act.

4. Qualifying Individuals-1: The Medicaid agency pays Medicare Part B premiums under the State buy-in process for individuals described in § 1902(a)(10)(E)(iv)(I) and subject to § 1933 of the Act.

B. Part A group premium payment arrangement entered into with the Social Security Administration. This arrangement covers the following groups: Qualified Disabled & Working Individuals provided by § 6408 of OBRA 1989 and Qualified Medicare beneficiaries provided by § 301 of P.L. 100-360 as amended by § 8434 of P.L. 100-647.

C. Payment of Part A and Part B deductible and coinsurance cost. Such payments are made in behalf of the following groups:

1. All individuals eligible for Title XVIII covered services.

2. Qualified Medicare beneficiaries provided by § 301 of P.L. 100-360 as amended by § 8434 of P.L. 100-647.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-02-3.2100, eff. January 1, 1991; amended, Virginia Register Volume 17, Issue 13, eff. April 11, 2001; Volume 19, Issue 18, eff. July 1, 2003.

12VAC30-20-90 Confidentiality and disclosure of information concerning Medicaid applicants and recipients

A. Definitions. The following words and terms when used in these regulations shall have the following meanings, unless the context clearly indicates otherwise:

"Agency" or "the Medicaid agency" means the Department of Medical Assistance Services or its designee.

"Client" means an applicant for, or recipient of, Medicaid benefits.

"Client information" or "client record" means any information, including information stored in computer data banks or computer files relating to a recipient or applicant, which was received in connection with the performance of any function of the agency and which either identifies a client or describes a client such that the client could be specifically identified.

"Provider" means any individual or organization that delivers a medical service to a recipient of, or applicant for, Medicaid benefits.

"The Plan" means the State Plan for Medical Assistance.

B. Purpose. Section 1902(a)(7) of the Social Security Act and 42 CFR 431.300 et seq. require a State Plan for Medical Assistance to provide safeguards to restrict the use or disclosure of information concerning applicants and recipients to purposes directly connected with the administration of the Plan. The rules herein are established to protect the rights of clients to confidentiality of their Medicaid information. Section 32.1-325.3 of the Code of Virginia requires the Board of Medical Assistance Services to promulgate regulations consistent with the foregoing.

C. Release of client information. Except as otherwise provided in these rules, no person shall obtain, disclose or use, or authorize, permit or acquiesce the use of any client information that is directly or indirectly derived from the records, files, or communications of the agency, except for purposes directly connected with the administration of the Plan or as otherwise provided by federal and state law. The agency can conduct all of the above administrative activities itself or it can contract some or all of them to other state agencies or private companies. These other entities must maintain client information confidential in accordance with the terms of these regulations. Purposes directly related to the administration of the Plan include; but are not limited to:

1. Establishing eligibility;

2. Determining the amount of medical assistance;

3. Providing services for recipients; and

4. Conducting or assisting in an investigation, prosecution or a civil or criminal proceeding related to the administration of the Plan.

D. Safeguarding client information. All information associated with an applicant or recipient that could disclose the individual's identity is confidential and shall be safeguarded. Such information shall include, but is not limited to:

1. Name, address and all types of identification numbers assigned to the client;

2. Medical services provided to the client;

3. Social and economic conditions or circumstances of the client;

4. Agency evaluation of the client's personal information;

5. Medical data about the client, including diagnoses and past histories of disease or disabilities;

6. Information received for verifying income, eligibility, and amount of medical assistance payments; and

7. Information received in connection with identification of legally liable third party resources, and information received in connection with processing and rendering decisions of recipient appeals.

E. Ownership of records.

1. All client information contained in the agency records is the property of the agency, and employees of the agency shall protect and preserve such information from dissemination except as provided herein.

2. Original client records are not to be removed from the premises by individuals other than authorized staff of the agency, except by a court order. The agency may destroy records pursuant to records retention schedules consistent with state and federal regulations.

F. Disclosure of client information.

1. Conditions for releasing information. Access to information concerning applicants or recipients must be restricted to persons or agency representatives who are subject to the standards of confidentiality that are consistent with that of the agency.

a. Consent. As part of the application process for Medicaid, the client shall be informed of the need to consent to the release of information necessary for verifying eligibility. Whenever a person, agency or organization that is not performing one or more of the functions delineated in subsection C of this section requests client information, the Medicaid agency must obtain written permission to disseminate the information from the client or the person legally responsible for the client whenever possible. A release for information obtained from the client by the requesting agency also satisfies this requirement.

b. Client information may be released without the client's written permission under the following conditions:

(1) An emergency exists and prior attempts to contact the client or legally responsible persons for permission have been unsuccessful;

(2) A court of competent jurisdiction has ordered the production of information and the agency does not have sufficient time to notify the client or legally responsible person before responding to the order;

(3) The release of such client information is necessary to prevent loss of, or risk to, life or health of the client;

(4) In the case of third party liability, as explained in subdivision G 2 of this section; or

(5) Release is not otherwise prohibited by law or regulation.

c. Notification. If one of the conditions above is met and consent is not obtained before the release of the information, the agency must provide written notification to the client or legally responsible person within five work days after disclosure.

d. Consent process. The consent for release of information shall contain the following:

(1) The name of the agency or entity supplying the information and the name of the requesting party;

(2) A description of the information to be released;

(3) A statement that the consent is limited to the purpose designated;

(4) The length of time the consent is valid; and

(5) The consent must be signed and dated by the client. The client may add other information which may include, but is not limited to, a statement specifying the date, event or condition upon which the consent expires.

G. Information exchanges.

1. Governmental agencies.

a. Confidential information can be released to other governmental agencies without the consent of the client for purposes of complying with state or federal statutes or regulations pursuant to written data exchange agreements. Such agreements will (i) specify the information to be exchanged; (ii) the titles of all agency officials with the authority to request income and eligibility information; (iii) the methods, including the formats to be used, and the timing for requesting and providing the information; (iv) the safeguards limiting the use and disclosure of the information as required by federal or state law or regulations; (v) the method, if any, the agency will use to reimburse reasonable costs of furnishing the information; and (vi) in the case of an agreement between a SWICA or a UC agency and the Medicaid agency, that the Medicaid agency will obtain information on applicants at least twice monthly. Such information exchanged by governmental agencies is made available only to the extent necessary to assist in the valid administrative needs of the governmental agency receiving the information and adequate safeguards shall be maintained to protect the information from further disclosure. Information received under § 6103(1) of the Internal Revenue Code of 1954 is exchanged only with agencies or delegated entities authorized to receive such information.

b. Medical assistance information contained in the records of the local departments of social services may be disclosed for purposes directly connected with the Medicaid program to providers of services enrolled in the Medical Assistance Program for the purpose of verifying a client's status as a Medicaid recipient.

2. Information exchanged in third party liability cases. Client information may be disclosed without consent in the recovery of monies for which third parties are liable for payment of claims. All such third parties shall be notified of the rules for safeguarding client information. The notification shall incorporate a written statement which advises third parties of the Medicaid program's client confidentiality regulations, specifies that clients' names, addresses and medical services data are confidential, must only be used in the administration of the Medicaid program and must not be released to any other person or entity in a manner inconsistent with the governing regulations. The notice shall further include the following statement. "Any willful violation of the governing regulations constitutes a Class 1 misdemeanor and may be punishable accordingly."

H. Client's right of access to information.

1. Client's right to access. Any client has the right to obtain personal information held by the agency or its representative. Upon written or verbal request, the client shall be permitted to review or obtain a copy of the information in his record with the following exceptions:

a. Information that the agency is required to keep confidential from the client pursuant to subdivision 1 of § 2.2-3705.5 of the Code of Virginia, or any other applicable law; or;

b. Information that would breach another individual's right to confidentiality.

2. Process for disclosure. Consistent with the Virginia Freedom of Information Act, § 2.2-3704, Code of Virginia, the agency shall provide access within five work days after the receipt of the request. The agency shall make disclosures to applicants and recipients during normal business hours. Copies of the requested documents shall be provided to the client or a representative at reasonable standard charges for document search and duplication.

3. Types of information available for client access. The client shall be permitted to be accompanied by a person or persons of the client's choice and may grant permission verbally or in writing to the agency to discuss the client's file in such person's presence. Upon request and proper identification of any client or agent of the client, the agency shall grant to the client or agent the right to review the following:

a. All personal information about the client except as provided in subdivision 1 of § 2.2-3705.5 of the Code of Virginia; and

b. The identity of all individuals and organizations not having regular access authority that request access to the client's personal information.

4. Contested information. Pursuant to § 2.2-3806 of the Government Data Collection and Dissemination Practices Act, a client may contest the accuracy, completeness or relevancy of the information in his record. Correction of the contested information, but not the deletion of the original information if it is required to support receipt of state or federal financial participation, shall be inserted in the record when the agency concurs that such correction is justified. When the agency does not concur, the client shall be allowed to enter a statement in the record refuting such information. Corrections and statements shall be made a permanent part of the record and shall be disclosed to any person or entity that receives the disputed information.

I. Distribution of information to applicants and recipients. All materials distributed to applicants, recipients, or medical providers must directly relate to the administration of the Medicaid program and have no political implications. The agency must not distribute materials such as holiday greetings, general public announcements, voting information, or alien registration notices. The agency may distribute materials directly related to the health and welfare of applicants and recipients, such as announcements of free medical examinations, availability of surplus food and consumer protection information.

J. Publicizing safeguarding requirements. The agency shall inform clients in writing as follows:

Personal information regarding applicants for or recipients of Medicaid must be maintained confidential pursuant to state and federal law. Consistent with §§ 32.1-325.4 and 18.2-11 of the Code of Virginia, any violation of state regulations governing applicant or recipient confidentiality is punishable by up to 12 months in jail and a $2,500 fine.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-02-4.3100, eff. February 26, 1992; amended, Virginia Register Volume 25, Issue 14, eff. April 15, 2009.

12VAC30-20-100 Standards governing general and special hospitals and convalescent and nursing homes

Title 32 of the Code of Virginia authorizes the State Board of Health to adopt and promulgate reasonable rules and regulations as to standards of health to be maintained and such other matters as will promote the safety and ensure proper attention and service to and care of patients and inmates of private or public hospitals and institutions.

Rules and regulations governing general and special hospitals and convalescent and nursing homes in Virginia are published by the Virginia Department of Health under the above legal authority. Only facilities that meet the standards and requirements of these rules and regulations are licensed for operation within the Commonwealth of Virginia. Compliance is evaluated from scheduled and non-scheduled personal visits to each facility by a highly qualified specially designated staff element (Bureau of Medical and Nursing Facilities) Division of Licensure Certification of the Virginia Department of Health. Rules and regulations are available for review upon request.

Intermediate care facilities in mental institutions are licensed by the Department of Behavioral Health and Developmental Services as a condition for certification as an ICF facility by the Department of Health's Bureau of Medical and Nursing Facilities.

Mental hospitals and institutions for individuals with intellectual disabilities, which render hospital or skilled nursing home services, are licensed by the Department of Behavioral Health and Developmental Services and are certified for the Title XVIII Program by the Virginia Department of Health's Bureau of Medical and Nursing Facilities.

Descriptions of standards utilized for licensing and certifying these institutions, published in official, bound form are available for review upon request.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-4.1110, eff. December 20, 1973; amended, Virginia Register Volume 42, Issue 11, eff. February 11, 2026.

12VAC30-20-110 Nursing facility resident drug utilization review

1. Definitions. The following words and terms, when used in this regulation, shall have the following meanings unless the context clearly indicates otherwise:

"DMAS" means the Department of Medical Assistance Services consistent with the Code of Virginia, Chapter 10, Title 32.1, §§ 32.1-323 et seq.

"Drug utilization review" means a formal continuing program for assessing medical and/or drug use data against explicit standards and, as necessary, introducing remedial strategies.

"Drug Utilization Review Committee (DUR Committee)" means a committee composed of knowledgeable health care professionals who make recommendations for developing and modifying drug therapy review standards or criteria, participate in retrospective reviews, recommend remedial strategies, and evaluate the success of the interventions.

"Exceptional drug utilization pattern" means 1) a pattern of drug utilization within a nursing facility that differs substantially from predetermined standards established pursuant to § 3(B); 2) individual resident's drug use patterns that differ from the established standards; or 3) individual resident's drug use patterns that exhibit a high risk for drug therapy induced illness.

"Retrospective drug review" means the drug utilization review process that is conducted using historic or archived medical and/or drug use data.

"Targeted facility" means a nursing facility where residents' patterns of drug utilization demonstrate an exceptional drug utilization pattern as defined herein.

2. Scope

A. Medicaid shall conduct a drug utilization review program for covered drugs prescribed for nursing facility residents. The program shall help to ensure that prescriptions are appropriate, medically necessary, and are not likely to cause adverse actions. The primary objectives are 1) improvement in the quality of care; 2) conserving program funds and individual expenditures; and 3) maintaining program integrity (i.e., controlling problems of fraud and benefit abuse).

B. Retrospective drug utilization review will be conducted on an ongoing basis in targeted nursing facilities demonstrating exceptional drug utilization patterns.

C. With the aim of improving prescribing practices, the program shall provide for ongoing educational outreach programs to educate practitioners on common drug therapy problems.

3. Utilization Review Process

A. The program shall provide, through its drug claims processing and information retrieval systems, for the ongoing periodic examination of claims data and other records for targeted facilities to identify patterns of inappropriate or medically unnecessary care for individuals receiving benefits under Title XIX of the Social Security Act.

B. The program shall, on an ongoing basis, assess data on drug use against predetermined standards (as described in this section) including, but not limited to, monitoring for therapeutic appropriateness, overutilization and underutilization, appropriate use of generic products, therapeutic duplication, drug-disease contraindications, drug/drug interactions, incorrect drug dosage or duration of treatment, clinical abuse/misuse, fraud, and, as necessary, introduce to physicians and pharmacists remedial strategies in order to improve the quality of care.

C. The Department of Medical Assistance Services may assess data on drug use against such standards as the American Hospital Formulary Service Drug Information (1995, as amended), United States Pharmacopeia-Drug Information (1995, as amended), American Medical Association Drug Evaluations (1993, as amended), and peer-reviewed medical literature.

4. Drug Use Review Committee

A. DMAS shall provide for the establishment of a drug use review committee (hereinafter referred to as the "DUR Committee"). The Director of DMAS shall determine the number of members and appoint the members of the DUR committee.

B. The membership of the DUR Committee shall include health care professionals who have recognized knowledge and expertise in one or more of the following areas:

1. The clinically appropriate prescribing of covered drugs;

2. The clinically appropriate dispensing and monitoring of covered drugs;

3. Drug use review, evaluation, and intervention; and

4. Medical quality assurance;

5. Clinical practice and drug therapy in the long term care setting.

C. The membership of the DUR Committee shall include physicians, pharmacists, and other health care professionals, including those with recognized expertise and knowledge in long term care.

D. Activities of the DUR Committee shall include, but not be limited to, the following:

1. Retrospective drug utilization review as defined in § 2 (B) of this regulation;

2. Application of standards as defined in § 3 (C) of this regulation; and

3. Ongoing interventions for physicians and pharmacists, targeted toward therapy problems of individuals identified in the course of retrospective drug use reviews.

E. The DUR Committee shall re-evaluate interventions after an appropriate period of time to determine if the intervention improved the quality of drug therapy, to evaluate the success of the interventions and recommend modifications as necessary.

5. Medical Quality Assurance

A. Documentation of drug regimens in nursing facilities shall, at a minimum:

1. Be included in a plan of care that must be established and periodically reviewed by a physician;

2. Indicate all drugs administered to the resident in accordance with the plan with specific attention to frequency, quantity, and type and identify who administered the drug (include full name and title); and

3. Include the drug regimen review prescribed for nursing facilities in regulations implementing 42 CFR 483.6.

B. Documentation specified in paragraph A will serve as the basis for drug utilization reviews provided for in these regulations.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-4.1470, eff. October 1, 1991.

12VAC30-20-120 Cooperative arrangements with the state vocational rehabilitation agency and with Title V programs and grantees

As the Single State Agency, the Department of Medical Assistance Services promulgated agreements with the following State agencies/activities concerning services rendered to Medical Assistance program eligible recipients.

1. Agreement with the Department of Social Services concerning responsibilities of that Department for (a) determination of eligibility, (b) provision of social services, (c) activity associated with fair hearings, (d) fraud, (e) quality control, (f) non-discrimination, (g) staffing, (h) staff development and recruiting, (i) maintenance of records, (j) review of local operations and (k) exchange of information (6-29-89, as amended).

2. Agreement with the Department of Vocational Rehabilitation concerning responsibilities of that Department for providing rehabilitation services necessary to render disabled individuals to attain a state of health which will permit them to engage in gainful employment and for providing liaison personnel to assist the State Agency in screening referrals for rehabilitation services (4-30-93, as amended).

3. Agreements with Department of Health programs for Maternal, Child Health, Family Planning and Crippled Children and for grantee project activities operated under these programs concerning provision of medical and social services to eligible recipients and reimbursements to be made for rendering covered services (3-12-93, as amended).

4. Agreements with Special Projects operating in this State under Federal grant funding procedures and which provide medical or dental services covered by the Medical Assistance Program concerning types and limits of services and reimbursement for services rendered.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-4.1610, eff. July 1, 1985.

Part II Liens/Estate Recoveries

12VAC30-20-130 Lien recoveries

The Commonwealth does not recover, through the imposition of liens, funds expended for recipients.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR 460-02-4.1710, eff. October 18, 1995.

12VAC30-20-140 (Repealed.)

History

• Historical Notes: Derived from VR 460-02-4.1730 § 1 through 4; Virginia Register Volume 11, Issue 26, eff. October 18, 1995; amended, Virginia Register Volume 23, Issue 14, eff. September 1, 2007; repealed, Virginia Register Volume 25, Issue 21, eff. July 23, 2009.

12VAC30-20-141 Estate recoveries

A. Definitions. The following words and terms when used in this regulation shall have the following meanings unless the context clearly indicates otherwise:

"Act" means the Social Security Act (42 USC § 1396) as applicable.

"Applicable medical assistance payment" means the amount of any medical assistance payments made on behalf of an individual under Title XIX of the Social Security Act.

"Claim" means, for the purposes of this section, action taken by DMAS to recover from the estate of an individual, who was age 55 or older when that person received medical assistance, the total amount of assistance paid for services consistent with the coverage and reimbursement policies in the State Plan for Medical Assistance.

"Cost effective" means that both the dollar amount of the medical assistance payments (claim) and the value of the estate at least exceed the administrative costs of recovery.

"Dual eligibles" mean individuals who are entitled to Medicare hospital insurance under Part A or supplementary medical insurance under Part B, or both, and are eligible for some form of Medicaid benefit.

"Estate" means, with respect to a deceased individual, (i) all real and personal property and other assets held by the individual at the time of death and (ii) any other real and personal property and other assets in which the individual had any legal title or interest (to the extent of such interest) at the time of his death.

"Homestead of modest value" means a home that is worth 50% or less of the average or median price, as contained in the most recent U.S. Census data or any other such source of home value information as published in the agency's guidance documents, of homes in the county or city, as appropriate, where the homestead is located as of the date of the individual's death.

"Undue hardship" means that DMAS has determined that enforcement of a claim to recover Medicaid benefits would result in substantial hardship to the devisees, legatees, and heirs or dependents of the deceased individual against whose estate the Medicaid claim exists.

B. Under the authority and consistent with the requirements of the Social Security Act § 1917 (the Act), the Commonwealth shall recover applicable medical assistance payments when such payments have been correctly or incorrectly paid on behalf of certain individuals. The Department of Medical Assistance Services (DMAS) shall provide notice of the Commonwealth's Medicaid estate recovery program at the time of application for medical assistance.

C. Adjustment and recovery. Adjustment or recovery can only be made after the death of the individual's surviving spouse, if any, and only at a time when the individual has no surviving child under age 21, or a blind or disabled child as defined in § 1614 of the Act. The Commonwealth shall seek adjustment or recovery of all medical assistance payments correctly paid on behalf of an individual who is age 55 or older under the State Plan as follows:

1. The Commonwealth shall seek adjustment or recovery from the estate of an individual who was age 55 or older when that person received medical assistance. Except as noted in subdivision 2 of this subsection, the Commonwealth shall recover amounts up to the total amount spent on the individual's behalf for medical assistance for items or services provided for the individual under the State Plan.

2. Dual eligible protection from recovery.

a. The Commonwealth shall recover from the estates of the following dual eligible individuals who are 55 years of age or older, who receive full Medicaid benefits in addition to Medicare: (i) qualified Medicare beneficiaries with full Medicaid benefits (QMB Plus), (ii) specified low-income Medicare beneficiaries with full Medicaid benefits (SLMB Plus), and (iii) Medicare beneficiaries eligible for a limited package of Medicaid benefits QMB, SLMB, qualified individuals (QI) or qualified disabled and working individuals (QDWI)). The Commonwealth shall recover from these individuals' estates medical assistance payments made on behalf of these individuals with the exception of Medicare cost-sharing benefits or for benefits described in § 1902(a)(10)(E). This exception shall apply to Medicare cost-sharing benefits (i.e., Part A and B premiums, deductibles, coinsurance, and copayments) with dates of service on or after January 1, 2010. The date of service for deductibles, coinsurance, and copayments shall be the date the request for payment is received by DMAS. The date of service for premiums shall be the date the Medicaid agency paid the premium.

b. The protection from estate recovery against Medicare cost-sharing benefits (premiums, deductibles, coinsurance, and copayments) set forth in subdivision 2 a of this section that is made for the applicable categories of protected dual eligible individuals described in that subdivision shall apply to approved mandatory and optional services set out in the State Plan for which Medicare cost sharing applies.

3. The Commonwealth shall recover from individuals with long-term care insurance policies. However, the Commonwealth shall not seek adjustment or recovery from the individual's estate for all Medicaid costs for nursing facility and other long-term care services if assets or resources are disregarded to the extent of payments made under a qualified long-term care partnership insurance policy.

4. Estate recovery and managed care. When a Medicaid beneficiary is enrolled in a managed care organization and services are provided by the managed care organization that are included under the State Plan, the Commonwealth shall seek adjustment or recovery from the individual's estate for the capitation payments in the Commonwealth's claim against the estate. When the individual enrolls in the managed care organization, the Commonwealth shall provide a separate notice to the individual that explains that the capitation payments made to the managed care organization are included in whole in the claim against the estate. The Commonwealth shall recover from the individual's estate the total capitation rate for the period the individual was enrolled in the managed care organization.

5. The following American Indian/Alaska Native (AI/AN) income, resources, and property shall be exempt from Medicaid estate recovery pursuant to § 1917(b)(3) of the Act for hardship applicable to federally recognized tribes:

a. Certain AI/AN income and resources (such as interests in and income derived from tribal land and other resources currently held in trust status and judgment funds from the Indian Claims Commission and the U.S. Claims Court) that are exempt from Medicaid estate recovery by other laws and regulations;

b. Ownership interest in trust or nontrust property, including real property and improvements:

(1) Located on a reservation (any federally recognized Indian tribe's reservation or near a reservation) as designated and approved by the Bureau of Indian Affairs of the U.S. Department of the Interior; or

(2) For any federally recognized tribe not described in this subdivision, located within the most recent boundaries of a prior federal reservation.

(3) Protection of nontrust property described in this subdivision is limited to circumstances when it passes from an Indian (as defined in § 4 of the Indian Health Care Improvement Act, 25 USC §§ 1601-1683) to one or more relatives (by blood, adoption, or marriage), including Indians not enrolled as members of a tribe and non-Indians, such as spouses and step-children, that their culture would nevertheless protect as family members; to a tribe or tribal organization or to one or more Indians, or all of these;

c. Income left as a remainder in an estate derived from property protected in this subdivision, that was either collected by an Indian, or by a tribe or tribal organization and distributed to an Indian or Indians, as long as the individual can clearly trace such income as coming from the protected property.

d. Ownership interests left as a remainder in an estate in rents, leases, royalties, or usage rights related to natural resources (including, but not necessarily limited to, extraction of natural resources or harvesting of timber, other plants and plant products, animals, fish, and shellfish) resulting from the exercise of federally protected rights, and income either collected by an Indian, or by a tribe or tribal organization and distributed to an Indian or Indians derived from these sources as long as the individual can clearly trace the interest as coming from protected sources.

e. Ownership interests in or usage rights to items not covered by this subdivision that have unique religious, spiritual, traditional, or cultural significance or rights, or all of these, that support subsistence or a traditional lifestyle according to applicable tribal law or custom.

6. The Commonwealth shall recover the following income, resources and property from the estates of American Indians and Alaska Natives:

a. Ownership interests in assets and property, both real and personal, that are not described in this subdivision .

b. Any income and assets left as a remainder in an estate that do not derive from protected property or sources in this subdivision.

7. Reparation payments to individuals. Government reparation payments to special populations shall be exempt from Medicaid estate recovery.

8. Annuities. The Commonwealth considers annuities to be legal devices by which ownership of assets, such as estates, is defined and therefore may seek recovery from individuals' estates that may include such annuities.

D. Undue hardship. Whenever estate recovery would work an undue hardship on the deceased individual's heirs, the Commonwealth shall waive adjustment or recovery. Recovery from deceased individuals' estates shall be waived when the heirs are themselves Medicaid eligible. Anyone who may be affected by Medicaid estate recovery may apply for an undue hardship waiver. DMAS shall determine the merit of such applications.

1. Special consideration shall be shown in cases in which the estate subject to recovery is: (i) the sole income-producing asset of survivors (where such income is limited), such as a family farm or other family business; (ii) a homestead of modest value; or (iii) one in which other compelling circumstances exist as may be set out in agency guidance documents.

2. An undue hardship exists when the Commonwealth determines that it would not be cost effective to recover the assistance paid.

3. In cases where recovery is not waived and heirs of the estate from which recovery is sought wish to satisfy the Commonwealth's claim without selling a nonliquid asset that is subject to recovery, alternative methods of recovery may be considered. DMAS may also establish a reasonable payment schedule.

4. The Commonwealth may limit the hardship waiver to the time period during which the undue hardship circumstances existed or continue to exist.

5. An undue hardship shall not exist if the beneficiary created the hardship by resorting to estate planning methods under which the beneficiary divested assets in order to avoid estate recovery.

E. DMAS shall establish collection procedures to include identification of the estate administrator or executor, determination of the medical assistance claim amount, notification procedures, and such other procedures as are appropriate to pursue the recovery of medical assistance expenditures. Such procedures will be set out in an agency guidance document.

F. Recovery or adjustment not cost effective. DMAS shall establish a cost effectiveness threshold below which estate recovery will not be pursued.

1. The Commonwealth may waive adjustment or recovery in cases in which it is determined that it would not be cost effective for the Commonwealth to recover from a deceased individual's estate. The estate administrator, executor, survivor, or heir does not need to assert undue hardship in such situations.

2. In determining whether recovery would be cost effective, the department may consider, but is not limited to consideration of, the following costs: staff time, litigation costs, expert witness fees, deposition expenses, travel expenses, office supplies, postage, advertising, and publishing costs. DMAS shall adjust the cost effective threshold as the agency's administrative costs change.

G. Appeals. The DMAS Appeals Division will administer appeals related to the recovery of funds pursuant to 12VAC30-110.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. July 23, 2009; amended, Volume 29, Issue 7, eff. January 2, 2013.

Part III Recipient Cost Sharing

12VAC30-20-150 Copayments and deductibles for categorically needy and QMBs for services other than under 42 CFR 447.53

A. The following charges are imposed on the categorically needy and Qualified Medicare Beneficiaries for services other than those provided under 42 CFR 447.53.

| Service* | Type Charge | Amount and Basis for Determination | | | | --- | --- | --- | --- | --- | | Deduct | Coins | Copay | | | | Inpatient Hospital | -0- | ‑0‑ | $75 | State's average daily payment of $594 is used as basis. | | Outpatient Hospital Clinic | ‑0‑ | ‑0‑ | $3.00 | State's average payment of $136 is used as basis. | | Clinic Visit | ‑0‑ | ‑0‑ | $1.00 | State's average payment of $29 is used as basis. | | Physician Office Visit | ‑0‑ | ‑0‑ | $1.00 | State's average payment of $23 is used as basis. | | Eye Examination | ‑0‑ | ‑0‑ | $1.00 | State's payment of $30 is used as basis. | | Prescriptions: | | | | | | --Generic | ‑0‑ | ‑0‑ | $1.00 | State's average per generic script of $25 is used as payment basis. | | --Brand Name | ‑0‑ | ‑0‑ | $3.00 | State's average per brand-name script of $97 is used as payment basis. | | Home Health Visit | ‑0‑ | ‑0‑ | $3.00 | State's average payment of $56 is used as basis. | | Other Physician Services | ‑0‑ | ‑0‑ | $3.00 | State's average payment of $56 is used as basis. | | Rehab Therapy Services (PT, OT, Sp/Lang.) | ‑0‑ | ‑0‑ | $3.00 | State's average payment $78 is used as basis. |

*NOTE: The applicability of copays to emergency services is discussed further in this section.

B. The method used to collect cost sharing charges for categorically needy individuals requires that providers be responsible for collecting the cost sharing charges from individuals.

C. The basis for determining whether an individual is unable to pay the charge, and the means by which such an individual is identified to providers, is described in this subsection:

Providers will, based on information available to them, make a determination of the recipient's ability to pay the copayment. In the absence of knowledge or indications to the contrary, providers may accept the recipient's assertion that he or she is unable to pay the required copayment.

Recipients have been notified that inability to meet a copayment at a particular time does not relieve them of that responsibility.

D. The procedures for implementing and enforcing the exclusions from cost sharing contained in 42 CFR 447.53(b) are described in this subsection:

The application and exclusion of cost sharing is administered through the program's Medicaid Management Information System. Documentation of the certified computer system delineates, for each type of provider invoice used, protected eligible groups, protected services and applicable eligible groups and services.

Providers have been informed about: copay exclusions; applicable services and amounts; prohibition of service denial if recipient is unable to meet cost-sharing changes.

E. State policy does not provide for cumulative maximums on charges.

F. Emergency Services. No recipient copayment shall be collected for the following services:

1. Services provided in a hospital, clinic, office, or other facility that is equipped to furnish the required care, after the sudden onset of a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) that the absence of immediate medical attention could reasonably be expected to result in:

a. Placing the patient's health in serious jeopardy;

b. Serious impairment to bodily functions; or

c. Serious dysfunction of any bodily organ or part; and

2. All services delivered in emergency rooms.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-02-4.1810, eff. July 1, 1993; amended, Virginia Register Volume 19, Issue 18, eff. July 1, 2003; Volume 34, Issue 25, eff. September 5, 2018.

12VAC30-20-160 Copayments and deductibles for medically needy and QMBs for services other than under 42 CFR 447.53

A. The following charges are imposed on the medically needy and Qualified Medicare Beneficiaries for services other than those provided under 42 CFR 447.53.

| Service* | Type Charge | Amount and Basis for Determination | | | | --- | --- | --- | --- | --- | | Deduct | Coins | Copay | | | | Inpatient Hospital | -0- | ‑0‑ | $75 | State's average daily payment of $594 is used as basis. | | Outpatient Hospital Clinic | ‑0‑ | ‑0‑ | $3.00 | State's average payment of $136 is used as basis. | | Clinic Visit | ‑0‑ | ‑0‑ | $1.00 | State's average payment of $29 is used as basis. | | Physician Office Visit | ‑0‑ | ‑0‑ | $1.00 | State's average payment of $23 is used as basis. | | Eye Examination | ‑0‑ | ‑0‑ | $1.00 | State's payment of $30 is used as basis. | | Prescriptions: | | | | | | --Generic | ‑0‑ | ‑0‑ | $1.00 | State's average per generic script of $25 is used as payment basis. | | --Brand Name | ‑0‑ | ‑0‑ | $3.00 | State's average per brand-name script of $97 is used as payment basis. | | Home Health Visit | ‑0‑ | ‑0‑ | $3.00 | State's average payment of $56 is used as basis. | | Other Physician Services | ‑0‑ | ‑0‑ | $3.00 | State's average payment of $56 is used as basis. | | Rehab Therapy Services (PT, OT, Sp/Lang.) | ‑0‑ | ‑0‑ | $3.00 | State's average payment $78 is used as basis. |

*NOTE: The applicability of copays to emergency services is discussed further in this section.

B. The method used to collect cost sharing charges for medically needy individuals requires that providers be responsible for collecting the cost sharing charges from individuals.

C. The basis for determining whether an individual is unable to pay the charge, and the means by which such an individual is identified to providers, is described in this subsection:

Providers will, based on information available to them, make a determination of the recipient's ability to pay the copayment. In the absence of knowledge or indications to the contrary, providers may accept the recipient's assertion that he or she is unable to pay the required copayment.

Recipients have been notified that inability to meet a copayment at a particular time does not relieve them of that responsibility.

D. The procedures for implementing and enforcing the exclusions from cost sharing contained in 42 CFR 447.53(b) are described in this subsection:

The application and exclusion of cost sharing is administered through the program's Medicaid Management Information System. Documentation of the certified computer system delineates, for each type of provider invoice used, protected eligible groups, protected services and applicable eligible groups and services.

Providers have been informed about: copay exclusions; applicable services and amounts; and prohibition of service denial if recipient is unable to meet cost-sharing changes.

E. State policy does not provide for cumulative maximums.

F. Emergency Services. No recipient copayment shall be collected for the following services:

1. Services provided in a hospital, clinic, office, or other facility that is equipped to furnish the required care, after the sudden onset of a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) that the absence of immediate medical attention could reasonably be expected to result in:

a. Placing the patient's health in serious jeopardy;

b. Serious impairment to bodily functions; or

c. Serious dysfunction of any bodily organ or part; and

2. All services delivered in emergency rooms.

History

• Statutory Authority: §32.1-324 and 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-02-4.1830, eff. July 1, 1993; amended, Virginia Register Volume 19, Issue 18, eff. July 1, 2003; Volume 34, Issue 25, eff. September 5, 2018.

12VAC30-20-170 Basis of payment for reserving beds during a recipient's absence from an inpatient facility

1. Payment is made for reserving beds in long-term care facilities for recipients during their temporary absence for the following purpose: For leaves of absence up to 18 days per year for any reason other than inpatient hospital admissions.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-4.1930, eff. March 1, 1992.

12VAC30-20-180 Definition of a claim by service

A. Claims.

| | SERVICE | CLAIM | | --- | --- | --- | | | A) Inpatient Hospital | A Bill for Service | | | B) Outpatient Hospital | A Bill for Service | | | C) Rural Health Clinic | A Line Item for Service | | | D) Laboratory and X-Ray | A Line Item of Service | | | E) Skilled Nursing | A Bill for Service | | | F) EPSDT | A Bill for Service | | | G) Family Planning | A Bill for Service or Line Item depending on provider type | | | H) Physician | A Line Item of Service | | | I) Other Medical | A Bill for Service or Line Item depending on provider type | | | J) Home Health | A Bill for Service | | | K) Clinic | A Line Item for Service | | | L) Dental | A Line Item of Service | | | M) Pharmacy | A Line Item of Service | | | N) Intermediate Care | A Bill for Service | | | O) Transportation | A Line Item of Service | | | P) Physical Therapy | A Bill for Service or Line Item depending on provider type | | | Q) Nurse Midwife | A Line Item of Service | | | R) Eyeglasses | A Line Item of Service |

B. All providers that enroll with Medicaid on or after October 1, 2011, shall submit electronically all claims for covered services they render in the fee-for-service program under the State Plans for Title XIX and XXI of the Social Security Act, and any waivers thereof, and enroll to receive electronic funds transfer (EFT) for payment of those services. All other providers shall comply with this electronic submission requirement by July 1, 2012.

1. Any provider who cannot comply with this electronic claims submission or EFT requirement may request an exception from DMAS for good cause shown.

2. Good cause may include, but is not limited to, (i) the unavailability of the infrastructure necessary to support electronic claims submission in the provider's geographic region; (ii) the absence of a mechanism for electronic submission for the particular claim type, such as in the case of a temporary detention order; (iii) the provider's inability to transact business through a banking institution capable of EFT; or (iv) financial hardship.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; Title XIX, 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-02-4.1950, eff. July 1, 1987; amended, Virginia Register Volume 31, Issue 3, eff. November 6, 2014.

Part IV Third Party Liability

12VAC30-20-190 Requirements for third party liability; identifying liable resources

1. Definitions

"IEVS" - the Income and Eligibility Verification System.

"Third Party" - any individual, entity or program that is or may be liable to pay all or part of the expenditures for medical assistance furnished under a State Plan.

"Title IV-A agency" - the organizational unit in the State, the Department of Social Service, that has the responsibility for determining eligibility for all groups covered by Medicaid.

"Title IV-D agency" - the organizational unit in the State, the Department of Social Services, that has the responsibility for administering or supervising the administration of a State plan for child support enforcement under Title IV-D of the Act.

"Title XIX agency" - the organizational unit in the State responsible for administering the implementation of programs created by the nineteenth amending title to the Social Security Act.

"TPQY" - Third Party Information Query system administered by the Social Security Administration.

"VEC" - the Virginia Employment Commission (the state SWICA agency) which is the state organizational unit responsible for providing a work ready labor force, temporary income protection to workers involuntarily unemployed, and labor market and economic information.

2. Determining liability of third parties.

2.1. The agency takes all reasonable measures to determine the legal liability of third parties to pay for care and services furnished under the Plan. The Commonwealth is a "209b" state and all eligibility is determined by the Department of Social Services (DSS). At a minimum, such measures include the requirements specified below.

2.2. Health insurance information.

A. Health insurance information is obtained by the Title IV-A agency (DSS) during the initial application and redetermination processes for Medicaid eligibility.

B. The information is coded on the recipient's eligibility card and in the computer system.

C. Health insurance information may include, but is not limited to, the policy holder's name, the relationship to the applicant or recipient, the policy holder's social security number (SSN) and policy number, and the name and address of the insurance company.

D. The Title XIX agency has an agreement with the IV-A agency to collect and to transmit from the applicant or recipient during the initial application and each redetermination process such health insurance information as is useful in identifying legally liable third party resources so that the Medicaid agency may process claims under the third party liability payment procedures specified in 42 CFR 433.139 b-f. Health insurance information may include, but is not limited to, those elements described in item C above.

E. The Title IV-A agency incorporates into the eligibility case file the names and SSNs of absent or custodial parents of Medicaid recipients to the extent such information is available.

F. Payment of health insurance premiums when identified as cost effective.

2.3. Exchange of data.

The Title XIX agency obtains and uses information for the purpose of determining the legal liability of third parties so that the agency may process under the third party liability payment procedures specified in § 433.139 b-f, and the agency utilizes information from these sources:

1. The Title XIX agency does not have an agreement with SWICA or SSA wage and earning files data since the eligibility information is obtained from the IV-A agency. The IV-A agency is responsible for obtaining all necessary eligibility information for applicants and uses IEVS, TPQY and VEC files.

2. The IV-A agency utilizes all wage and earnings information appropriate to the determination of eligibility. The DSS obtains its information through IEVS (the alternate information source allowed by 42 CFR 433.138 (d)(2)) which obtains information from Department of Motor Vehicles (DMV), Internal Revenue Service (IRS) and VEC. The Title IV-A agency updates the Title XIX agency's eligibility file which is then used for claims processing.

3. The Industrial Commission of Virginia (Workers' Compensation agency) has denied the Title XIX agency's request to provide data matches. Documentation of such denial has been provided to the HCFA Regional Office. The Title XIX agency will continue its efforts to obtain data matches with this agency.

4. Agreements to obtain data matches from the DMV (State motor vehicle accident report files) are presently in progress.

2.4. Diagnosis and trauma code edits.

1. The Title XIX agency takes action to identify those paid claims for Medicaid recipients that contain diagnosis codes 800-999 (ICDCM) International Classification of Disease, Ninth Revision Clinical Modification Volume I (as updated annually), inclusive, for the purpose of determining the legal liability of third parties so that the agency may process claims under the third party liability payment procedures specified in 42 CFR 433.139 b-f.

2. These system edits are used daily.

2.5. Follow-up procedures for identifying legally liable third party resources.

1. The Title XIX agency follows up on information within 30 days in order to identify legally liable third party resources for casualty cases.

a. Information is obtained from providers, Title XIX program representatives, third party monthly alert letters, insurance companies, attorneys, probation officers, social service agencies, recipients, newspaper articles, and clerks of court.

b. Information is retained in third party case files.

c. Within 30 days, the Title XIX agency determines the amount of monies paid for health services rendered to injured recipients. The responsible third party is identified and within 30 days is notified that the Commonwealth has a lien for monies expended by the agency for the injured recipient.

d. The agency issues several lien status letters which have 90 day reply due dates depending on the age of the accident date, the lien amount and the agency's historical experience with the third party or the third party's attorney.

e. After no response is received to several lien status letters, the case is referred to the Office of the Attorney General for investigation and/or collection.

2. The agency uses the following procedures for trauma code edits.

a. The system produces monthly third party alert letters from the edits' applications. In third party alert letters, the affected recipients are requested to advise the Title XIX agency about the necessity for their treatment and if attorneys, insurance companies or other third parties are involved in their case. This information is utilized within 30 days of receipt to open cases for recovery of funds where applicable. This information is not entered into the eligibility case file where the agency enters only the individual's health insurance coverage, but is retained in the third party case files.

b. New information as obtained is added to third party case files on a daily basis.

3. The Title XIX agency follows up on health insurance information within 60 days in order to identify legally liable third party resources and incorporates this information into the eligibility case file so that the agency may process claims under the third party liability payment procedures specified under § 433.139 b-f.

The health insurance information which might not be obtained during the eligibility process can appear during invoice processing and this information is researched and investigated and added to the recipient eligibility file.

4. Once an agreement with the state motor vehicle agency has been obtained, the Title XIX agency will incorporate the procedures identifying the methods used by the agency to identify legally liable third party resources.

2.6. Information and data exchanges.

The Title XIX agency complies with 42 CFR 433.138 (h)(1) and (2) and at the present time has a written agreement with the Title IV-D agency. No reimbursement has been requested by the IV-D agency for reasonable costs incurred in furnishing information to the Title XIX agency.

2.7. Reports.

The Title XIX agency will produce such reports as the Secretary prescribes for the purpose of determining compliance under § 433.138 of the CFR and evaluating the effectiveness of the third party liability identification system.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-4.2210, eff. November 5, 1990.

12VAC30-20-200 Requirements for third party liability; payment of claims

Requirements for third-party liability payment of claims include the following:

1. Probable liability is established at the time the claim is filed.

a. When the Title XIX agency has established the probable existence of third-party liability at the time the claim is filed, the agency rejects the claim and returns it to the provider for a determination of the amount of liability. The establishment of third-party liability takes place when the agency receives confirmation from the provider or a third-party resource indicating the extent of third-party liability. When the amount of liability is determined, the agency pays the claim to the extent that maximum payment allowed under the agency's payment schedule exceeds the amount of the third-party payment.

b. Exhausting all available third-party resources is the responsibility of the providers. The Medicaid Enterprise System (MES) does not allow payments to be made by Virginia Medicaid unless the invoice indicates that the third party has either paid or denied the claim.

c. There are certain circumstances in which cost avoidance may not be utilized:

(1) Medical support enforcement. In the case of any service covered under Medicaid provided to an individual on whose behalf child support enforcement is being carried out by the IV-D agency, Medicaid makes payment for such service in accordance with the usual payments schedule. These payments are made without regard to any third-party liability, if such third-party liability is derived, through insurance or otherwise, from the parent whose obligation to pay support is being enforced by the IV-D agency. Medicaid shall make these payments, provided that the payments have not been made by such third party within 100 days after such service is furnished.

Providers shall not be required to bill the third party in this situation. When the provider bills Medicaid, the provider must certify either:

(a) That the provider has not billed the third party documented on the claim due to medical support enforcement; or

(b) That the provider has billed the third party documented on the claim but has not received payment or denial for the service from the third party within 100 days after the provider of such services initially submitted a claim. In this case, up to 100 days must elapse after the provider of such services initially submits a claim.

(2) Preventive pediatric care. When the claim is for preventive pediatric care, including services covered under the Early and Periodic Screening, Diagnosis and Treatment (EPSDT) benefit, the Commonwealth makes payment for such services in accordance with the usual payment schedule without regard to the liability of a third party for payment for such services, unless the state has made a determination related to cost-effectiveness and access to care that warrants cost avoidance for up to 90 days.

2. Virginia complies with the following requirements:

a. The requirement for states to apply cost-avoidance procedures to claims for prenatal services, including labor, delivery, and postpartum care services, in accordance with the provisions of § 1902(a)(25)(E) of the Social Security Act;

b. The requirement for states to make payments without regard to potential third-party liability for pediatric preventive services, unless the state has made a determination related to cost-effectiveness and access to care that warrants cost avoidance for up to 90 days, in accordance with the provisions of § 1902(a)(25)(E) of the Social Security Act; and

c. The requirement for state flexibility to make payments without regard to potential third-party liability for up to 100 days for claims related to child support enforcement beneficiaries, in accordance with the provisions of § 1902(a)(25)(F) of the Social Security Act.

3. Probable liability is not established or benefits are not available at the time claim is filed. If the probable existence of third-party liability cannot be established or third-party benefits are not available to pay the recipient's medical expenses at the time the claim is filed, the agency pays the full amount allowed under the agency's payment schedule.

4. Recovery of reimbursement.

a. When the Title XIX agency learns of the existence of a liable third party after a claim is paid, or benefits become available from a third party after a claim is paid, the Title XIX agency seeks recovery of reimbursement within 60 days after the end of the month it learns of the existence of the liable third party or benefits become available.

b. Reimbursement is sought by the Title XIX agency unless the agency determines that recovery will not be cost-effective. The agency uses the threshold amount of $50 as a guideline in its attempts to recover from liable third parties in casualty cases. This $50 guideline is used in consideration with other factors (i.e., expense and difficulty of recovery) in deciding whether to pursue recoveries in the range of smaller dollar expenditures (less than $50). The threshold amount in the determination for the recovery of funds by the health insurance unit is $40. However, the threshold amount may be waived when the agency deems it to be economically and administratively feasible to collect less than the stated amounts. The threshold amounts are based on effectiveness with normal effort for the recovery of funds. Should it be determined that a recovery effort would be cost-effective, then attempts are made for recovery of amounts below the threshold levels.

5. Prior authorizations.

a. The DMAS payment of a claim for a medical item or service shall be the equivalent of the medical assistance recipient having obtained a prior authorization for the item or service from the third party, other than Medicare plans.

b. No third-party payer shall deny a claim that is submitted by DMAS solely on the basis of the medical assistance recipient's failure to obtain a prior authorization under the third-party payer's rules for the medical item or service.

c. A third-party payer shall respond to an inquiry by DMAS regarding a claim for payment of a medical item or service that was submitted to the third party not later than three years after the date of the provision of such medical item or service; the third-party payer must respond within 60 days of receiving the inquiry.

6. DMAS meets all the requirements of §§ 8.01-66.9 and 8.01-66.9:2 of the Code of Virginia with respect to liens on claims for personal injury.

7. To obtain information about a Medicaid member's enrollment status or an itemization of lien against a personal injury claim, the member or the member's authorized representative shall furnish DMAS or the DMAS designated representative with relevant information that DMAS or the DMAS designated representative shall request. The member or the member's authorized representative shall use the DMAS public-facing portal designed for electronic data interchange to submit any requested information to DMAS or the DMAS designated representative. The following information is required to be furnished to DMAS or the DMAS designated representative:

a. A letter of representation signed by the Medicaid member or the member's authorized representative and dated within the last 12 months if the request is made by a representative.

b. A Health Insurance Portability and Accountability Act of 1996 (HIPAA) complaint release form signed by the member and dated within the last 12 months that authorizes both DMAS and the Office of the Attorney General to disclose medical information to the member or the member's authorized representative and to any other third parties or contractors that are or will be involved with the lien.

c. The full legal name of the Medicaid member.

d. The full social security number of the Medicaid member.

e. A copy of the front and back of the Medicaid member's health insurance card.

f. A description of the member's injuries sustained as a result of the accident.

g. An itemized statement of the Medicaid member's medical damages, including providers and dates of service, along with copies of medical bills.

h. The date and location of the accident, the identities of all parties involved in the accident, and a copy of the police report, if available.

i. The full name, mailing address, telephone number, and email address of the authorized representative named in the HIPAA release to whom DMAS should direct communications about the Medicaid lien.

j. If any of the required information changes after the date the information is submitted to DMAS, the member or the member's authorized representative shall notify DMAS of the change as soon as possible.

8. To make a request for a reduction of any portion of a Medicaid lien, the member or the member's authorized representative shall furnish DMAS or the DMAS designated representative with relevant information that DMAS or the DMAS designated representative shall request. The member or the member's authorized representative shall use the DMAS public-facing portal designed for electronic data interchange to submit any requested information to DMAS or the DMAS designated representative. The following information is required to be furnished to DMAS or the DMAS designated representative:

a. The member's prognosis and anticipated future treatment expenses.

b. If the member is permanently disabled as a result of the accident, the disability rating.

c. The member's current income, financial resources, and employment status.

d. The amount of all other liens or claims against the member's personal injury claim.

e. Whether any liability insurance policies are available and, if so, the amount paid by each and the policyholder's name for each.

f. Whether any settlements have occurred related to the accident, including the amount of the settlement, the terms, and a copy of the signed settlement agreement.

g. Whether any lawsuits have been filed related to the accident, the jurisdiction and case number, a copy of the complaint, and any other filings.

h. The amount of all medical reimbursement payments coverage related to the accident, such as Medical Payments Insurance, also known as "medpay."

i. An itemized statement of all attorney fees and costs and any voluntary reductions.

j. A written explanation of why the request is being made, along with details about the compromise or waiver that is being requested and any other facts or documentation that are being relied upon to support the request.

k. If any of the required information changes after the date the information is submitted to DMAS, the member or the member's authorized representative shall notify DMAS of the change as soon as possible.

9. To make a request to remove charges contained in the DMAS itemization of lien that are believed to be unrelated to the personal injury claim of the member, the member or the member's authorized representative shall furnish DMAS or the DMAS designated representative with relevant information that DMAS or the DMAS designated representative shall request. The member or the member's authorized representative shall use the DMAS public-facing portal designed for electronic data interchange to submit any requested information to DMAS or the DMAS designated representative. The following information is required to be furnished to DMAS or the DMAS designated representative:

a. A written statement detailing the specific charges that the member or the member's authorized representative believes are unrelated to the personal injury claim.

b. Any and all documentation from the member or the member's authorized representative to any third party detailing claimed medical damages, itemized medical bills, or other related information, including demand packages, list of medical specials, and correspondence concerning medical damages.

c. Any and all documentation showing where the member or the member's authorized representative informed any third party that certain charges were unrelated.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-4.2220, eff. July 4, 1990; amended, Virginia Register Volume 41, Issue 16, eff. May 8, 2025.

12VAC30-20-205 Health Insurance Premium Payment for Kids

A. Definitions. The following words and terms when used in this section shall have the following meanings unless the context clearly indicates otherwise:

"Case" means all family members who are eligible for coverage under the qualified employer-sponsored insurance plan and who are eligible for Medicaid.

"Code" means the Code of Virginia.

"DMAS" means the Department of Medical Assistance Services consistent with Chapter 10 (§ 32.1-323 et seq.) of Title 32.1 of the Code of Virginia.

"DSS" means the Department of Social Services consistent with Chapter 1 (§ 63.2-100 et seq.) of Title 63.2 of the Code of Virginia.

"Family member" means an individual in the household, who is not a parent and who is related by blood, marriage, adoption, or legal custody.

"Group health plan" means a plan which meets § 5000(b)(1) of the Internal Revenue Code of 1986 and includes continuation coverage pursuant to Title XXII of the Public Health Service Act (42 USC § 201 et seq.), § 4980B of the Internal Revenue Code of 1986, or Title VI of the Employee Retirement Income Security Act of 1974 (42 USC § 200I et seq.). Section 5000(b)(1) of the Internal Revenue Code provides that a group health plan is a plan, including a self-insured plan, of, or contributed to by, an employer (including a self-insured person) or employee association to provide health care (directly or otherwise) to the employees, former employees, or the families of such employees or former employees, or the employer.

"High deductible health plan" means a plan as defined in § 223(c)(2) of the Internal Revenue Code of 1986, without regard to whether the plan is purchased in conjunction with a health savings account (as defined under § 223(d) of the Internal Revenue Code of 1986).

"HIPP" means the Health Insurance Premium Payment Program administered by DMAS consistent with § 1906 of the Social Security Act (42 USC § 301 et seq.) (the Act).

"HIPP for Kids" means the Health Insurance Premium Payment Program administered by DMAS consistent with § 1906A of the Act.

"Member" means a person who is eligible for Medicaid as determined by DMAS or a DMAS designated agent, including the Department of Social Services.

"Network provider" means a provider who is enrolled with a DMAS contracted managed care organization (MCO) as a provider and meets the requirement for an expedited enrollment as a fee-for-service (FFS) Medicaid provider for payment and billing purposes.

"Parent" means the biological or adoptive parent, or the biological or adoptive parent and the stepparent, living in the home with the Medicaid-eligible child. The health insurance policyholder shall be a parent as defined in this section.

"Payee" means the insured employee who is the policy holder of the qualified employer-sponsored insurance plan who is paid the HIPP or HIPP for Kids premium and cost-sharing reimbursement.

"Premium" means the fixed cost of participation in the qualified employer-sponsored insurance plan, which cost may be shared by the employer and employee or paid in full by either party.

"Premium assistance subsidy" means the amount that DMAS will pay of the employee's cost of participating in the qualified employer-sponsored insurance plan to cover the Medicaid eligible member younger than 19 years of age if DMAS determines it is cost effective to do so.

"Qualified employer-sponsored insurance" as defined in § 2105(c)(10)(B) of the Social Security Act means a group health plan or health insurance coverage offered through an employer:

1. That qualifies as creditable coverage as a group health plan under § 2701(c)(1) of the Public Health Service Act;

2. For which the employer contribution toward any premium for such coverage is at least 40%; and

3. That is offered to all individuals in a manner that would be considered a nondiscriminatory eligibility classification for purposes of § 105(h)(3)(A)(ii) of the Internal Revenue Code of 1986 without regard to § 105(h)(3)(B)(i).

"State Plan" means the State Plan for Medical Assistance for the Commonwealth of Virginia.

B. Program purpose. The purpose of the HIPP for Kids program shall be to:

1. Enroll members who are eligible for coverage under a qualified employer-sponsored insurance plan.

2. Provide premium assistance subsidy for payment of the employee share of the premiums and other cost-sharing obligations for the Medicaid-eligible child younger than 19 years of age. In addition, to provide cost sharing for the child's parent who is not Medicaid eligible for items and services covered under the qualified employer-sponsored insurance that are also covered services under the State Plan. There is no cost sharing for parents for services not covered by the qualified employer-sponsored insurance.

3. Treat coverage under such qualified employer-sponsored insurance plan as a third-party liability consistent with § 1906 of the Social Security Act.

C. Cost effectiveness methodology.

1. DMAS shall evaluate the member to determine the appropriate managed care organization (MCO) capitation rate to be used. The capitation rate will be determined based on aid category, nursing facility or waiver eligibility, age, gender, and region.

2. DMAS shall adjust the capitation rate to exclude Medicaid services that are not available through commercial group health insurance policies. This requires that the capitation rate be adjusted to exclude services, including nursing facility and long-term services and supports provided in the Commonwealth Coordinated Care (CCC) Plus program as well as community mental health services and nonemergency transportation services available in CCC Plus and Medallion.

3. DMAS shall adjust the reduced capitation rate from subdivision 2 of this subsection to reflect the higher prices employer plans pay. The Virginia price factor shall be based on the national factor of 1.3 that is published by the Centers for Medicare and Medicaid Services.

4. The qualified employer-sponsored insurance plan cost for the member shall be increased to reflect the amount of coinsurance and other member cost sharing typically imposed on HIPP members and paid by DMAS. Such amount shall be determined by averaging the aggregate amount of such expenditures by DMAS in the most recently completed fiscal year by the number of HIPP members covered during the fiscal year.

5. The qualified employer-sponsored insurance plan cost determined in subdivision 4 of this subsection shall be increased to reflect the DMAS administrative expenses directly related to the HIPP program. This additional cost is determined based on the average total monthly compensation paid to each HIPP analyst employed by DMAS and divided by the anticipated caseload.

6. The cost effectiveness shall be affirmed if the adjusted capitation rate from subdivision 3 of this subsection equals or exceeds the adjusted qualified employer-sponsored insurance plan cost from subdivision 5 of this subsection.

D. Member eligibility.

1. DMAS shall obtain specific information on qualified employer-sponsored insurance available to the members in the case including the effective date of coverage, the services covered by the plan, the deductibles and copayments required by the plan, and the amount of the premium paid by the employer and employee. Coverage that is not comprehensive shall be denied premium assistance. A qualified employer-sponsored insurance plan must provide the following services in order to be considered comprehensive:

a. Physician services;

b. Inpatient and outpatient hospitalization;

c. Outpatient labs, shots, and x-rays; and

d. Prescription drugs.

2. All Medicaid-eligible family members younger than 19 years of age who are eligible for coverage under the qualified employer-sponsored insurance shall be eligible for consideration for HIPP for Kids except the following:

a. The member who is Medicaid eligible due to "spenddown"; or

b. The member who is currently enrolled in the qualified employer-sponsored insurance and is only retroactively eligible for Medicaid.

E. Application required. A completed HIPP for Kids application must be submitted to DMAS to be evaluated for program eligibility. The HIPP for Kids application consists of the forms prescribed by DMAS and any necessary information as required by the program to evaluate eligibility and determine if the plan meets the criteria for qualified employer-sponsored insurance.

F. Exceptions. The term "qualified employer-sponsored insurance" does not include coverage consisting of:

1. Benefits provided under a health flexible spending arrangement (as defined in § 106(c)(2) of the Internal Revenue Code of 1986);

2. A high deductible health plan (as defined in § 223(c)(2) of the Internal Revenue Code of 1986), without regard to whether the plan is purchased in conjunction with a health savings account (as defined under § 223(d) of the Internal Revenue Code of 1986); or

3. For self-employed individuals, qualified employer-sponsored insurance obtained through self-employment activities shall not meet the program requirements unless the self-employment activities are the family's primary source of income and the insurance meets the requirements of the definition of qualified employer-sponsored insurance in subsection A of this section. Family for this purpose includes family by blood, marriage, or adoption.

G. Payments. When DMAS determines that a qualified employer-sponsored insurance plan is eligible and other eligibility requirements have been met, DMAS shall provide for the payment of premium assistance subsidy and other cost-sharing obligations for items and services otherwise covered under the State Plan, except for the nominal cost-sharing amounts permitted under § 1916 of the Social Security Act.

1. Effective date of premium assistance subsidy. Payment of premium assistance subsidies and other cost-sharing obligations shall become effective on the first day of the month following an approved application for which qualified employer-sponsored insurance becomes effective. Payments shall be made to the individual who is carrying the qualified employer-sponsored insurance plan coverage.

2. Payments for deductibles, coinsurances, and other cost-sharing obligations.

a. Medicaid eligible children younger than 19 years of age pursuant to § 1906A of the Act. The Medicaid agency pays all premiums, deductibles, coinsurance, and other cost-sharing obligations for items and services covered under the State Plan, as specified in the qualified employer-sponsored insurance, without regard to limitations specified in § 1916 or 1916A of the Act, for eligible individuals younger than 19 years of age who have access to and elect to enroll in such coverage. The eligible individual is entitled to services covered by the State Plan that are not included in the qualified employer-sponsored insurance.

b. In order to receive reimbursement, the individual shall submit to DMAS an explanation of benefits or similar documentation from the insurance company or doctor's office showing the date of service (DOS), that the expense is the responsibility of the member or parent, that the expense was paid prior to the submission of the request, and sufficient identification codes for the DOS to enable DMAS to determine if the service is reimbursable before applying the remaining cost sharing criteria.

c. Reimbursement for cost sharing shall be processed on a quarterly basis.

d. Ineligible family members. When coverage for Medicaid-eligible family members younger than 19 years of age is not possible unless a parent who is not Medicaid eligible enrolls in qualified employer-sponsored health insurance, the Medicaid agency pays premiums for enrollment of the parent who is not Medicaid eligible and other family members who are eligible for coverage under the qualified employer-sponsored insurance. In addition, the agency provides cost sharing for the parent who is not Medicaid eligible for items and services covered under the qualified employer-sponsored insurance that are also covered services under the State Plan. There is no cost sharing for parents who are not Medicaid eligible for items and services not covered by the qualified employer-sponsored insurance.

3. Documentation required for premium assistance subsidy reimbursement. A payee to whom DMAS is paying a qualified employer-sponsored insurance premium assistance subsidy shall, as a condition of receiving such payment, provide documentation as prescribed by DMAS of the payment of the qualified employer-sponsored insurance plan premium, as well as payment of coinsurances, copayments, and deductibles for services received.

H. Cost-sharing wrap.

1. Premium assistance enrollment will be voluntary. Individuals enrolled in the Commonwealth's Health Insurance Premium Payment (HIPP) program are afforded the same member protections provided to all other Medicaid enrollees. Cost sharing shall only be charged to Medicaid members as permitted under §§ 1916 and 1916A of the Social Security Act. Cost sharing shall not exceed 5.0% of household income.

2. The Commonwealth will provide a cost-sharing wrap to any cost-sharing amounts of a Medicaid covered service that exceeds the cost-sharing limits described in the State Plan, regardless of whether individuals enrolled in a HIPP program receive care from a Medicaid participating provider or a nonparticipating provider.

3. To effectuate the cost-sharing wrap, the Commonwealth will encourage nonparticipating providers to enroll by conducting targeted outreach to inform nonparticipating Medicaid providers on how to enroll in Medicaid for the purposes of receiving payment from the Commonwealth for cost-sharing amounts that exceed the Medicaid permissible limits.

4. The Commonwealth will inform members regarding options available when the member obtains care from a nonparticipating provider, including, as applicable, reimbursement for out-of-pocket, cost-sharing costs from this provider.

5. In order to receive reimbursement, the individual shall submit to DMAS an explanation of benefits or similar documentation from the insurance company or doctor's office showing DOS, that the expense is the responsibility of the member or parent, that the expense was paid prior to the submission of the request, and sufficient identification codes for the DOS to enable DMAS to determine if the service is reimbursable before applying the remaining cost-sharing criteria.

6. Reimbursement for cost-sharing shall be processed on a quarterly basis.

I. Program participation requirements. Participants must comply with program requirements as prescribed by DMAS for continued enrollment in HIPP for Kids. Failure to comply with the following may result in termination from the program:

1. Submission of documentation of any changes to the qualified employer-sponsored insurance plan, to include any changes to the employee share of the premium expense, within 10 days of receipt of notice of the change.

2. Any household changes, including income and individuals in the household, must be reported within 10 days of the change.

3. Completion of annual redetermination.

4. Completion of consent forms. Participants may be required to complete a consent form to release information necessary for HIPP for Kids participation and program requirements as required by DMAS.

J. HIPP for Kids redetermination. DMAS shall redetermine the eligibility of the qualified employer-sponsored insurance periodically, at least every 12 months. DMAS shall also redetermine eligibility when changes occur with the qualified employer-sponsored insurance plan information that was used in determining HIPP for Kids eligibility.

K. Program termination. Participation in the HIPP for Kids program may be terminated for failure to comply or meet program requirements. Termination will be effective the last day of the month in which advance notice has been given (consistent with federal requirements at 42 CFR 431.211).

1. Participation may be terminated for failure to meet program requirements including the following:

a. Failure to submit documentation of payment of premiums;

b. Failure to provide information required for reevaluation of the qualified employer-sponsored insurance;

c. Loss of Medicaid eligibility for all household members;

d. Medicaid household member no longer covered by the qualified employer-sponsored insurance;

e. Medicaid-eligible child turns 19 years of age; or

f. Employer-sponsored health plan no longer meets qualified employer-sponsored insurance requirements.

2. Termination date of premiums. Payment of premium assistance subsidy shall end on whichever of the following occurs the earliest:

a. On the last day of the month in which eligibility for Medicaid ends;

b. The last day of the month in which the member loses eligibility for coverage in the qualified employer-sponsored insurance plan;

c. The last day of the month in which the child turns 19 years of age;

d. The last day of the month in which adequate notice has been given (consistent with federal requirements at 42 CFR 431.211) that DMAS has determined that the qualified employer-sponsored insurance plan no longer meets program eligibility criteria; or

e. The last day of the month in which adequate notice has been given (consistent with federal requirements at 42 CFR 431.211) that HIPP for Kids participation requirements have not been met.

L. Third-party liability. When members are enrolled in qualified employer-sponsored insurance plans, these plans shall become the first sources of health care benefits, up to the limits of such plans, prior to the availability of payment under Title XIX.

M. Appeal rights. Applicants and members shall be given the opportunity to appeal adverse agency decisions consistent with agency regulations for client appeals (12VAC30-110-10 through 12VAC30-110-370).

N. Provider requirements. Providers shall be required to accept the greater of the qualified employer-sponsored insurance plan's reimbursement rate or the Medicaid rate as payment in full and shall be prohibited from charging the member or the Medicaid program amounts that would result in aggregate payments greater than the Medicaid rate as required by 42 CFR 447.20.

O. Provider participation or enrollment. The Commonwealth will enroll network providers as full Medicaid providers or enroll as fee-for-service Medicaid providers solely for the purpose of receiving cost sharing, similar to processes related to enrolling Medicare-participating providers that serve dually eligible members. If the Commonwealth enrolls providers for the sole purpose of being reimbursed for cost sharing, the provider would make the decision to enroll knowing that the provider network would be the same as for other enrollees of the qualified employer-sponsored insurance plan. In either scenario, the member would never pay more than the permissible Medicaid copayment.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 2, eff. November 8, 2012; amended, Virginia Register Volume 38, Issue 12, eff. March 17, 2022.

12VAC30-20-210 State method on cost effectiveness of qualified employer-sponsored insurance plans

A. Definitions. The following words and terms when used in this section shall have the following meanings unless the context clearly indicates otherwise:

"Case" means all family members who are eligible for coverage under the qualified employer-sponsored insurance plan and who are eligible for Medicaid.

"Code" means the Code of Virginia.

"Cost effective" and "cost effectiveness" mean the reduction in Title XIX expenditures, which are likely to be greater than the additional expenditures for premiums and cost-sharing items required under § 1906 of the Social Security Act (the Act), with respect to such enrollment.

"DMAS" means the Department of Medical Assistance Services consistent with Chapter 10 (§ 32.1-323 et seq.) of Title 32.1 of the Code of Virginia.

"DSS" means the Department of Social Services consistent with Chapter 1 (§ 63.2-100 et seq.) of Title 63.2 of the Code of Virginia.

"Family member" means an individual in the household, who is not a parent and who is related by blood, marriage, adoption, or legal custody.

"Group health plan" means a plan that meets § 5000(b)(1) of the Internal Revenue Code of 1986, and includes continuation coverage pursuant to Title XXII of the Public Health Service Act, § 4980B of the Internal Revenue Code of 1986, or Title VI of the Employee Retirement Income Security Act of 1974. Section 5000(b)(1) of the Internal Revenue Code provides that a group health plan is a plan, including a self-insured plan, of, or contributed to by, an employer (including a self-insured person) or employee association to provide health care (directly or otherwise) to the employees, former employees, or the families of such employees or former employees, or the employer.

"High deductible health plan" means a plan as defined in § 223(c)(2) of Internal Revenue Code of 1986, without regard to whether the plan is purchased in conjunction with a health savings account (as defined under § 223(d) of the Internal Revenue Code of 1986).

"HIPP" means the Health Insurance Premium Payment Program administered by DMAS consistent with § 1906 of the Act.

"Member" means a person who is eligible for Medicaid as determined by DMAS or a DMAS-designated agent, including the Department of Social Services.

"Network provider" means a provider that is enrolled with a DMAS contracted managed care organization (MCO) as a provider and meets the requirement for an expedited enrollment as a fee-for-service (FFS) Medicaid provider for payment and billing purposes.

"Parent" means the biological or adoptive parent, or the biological or adoptive parent and the stepparent, living in the home with the Medicaid-eligible child. The health insurance policyholder shall be a parent as defined in this section.

"Payee" means the insured employee who is the policy holder of the qualified employer-sponsored insurance plan who is paid the HIPP or HIPP for Kids premium and cost-sharing reimbursement.

"Premium" means the fixed cost of participation in the group health plan; such cost may be shared by the employer and employee or paid in full by either party.

"Premium assistance subsidy" means the portion that DMAS will pay of the employee's cost of participating in a qualified employer-sponsored insurance plan to cover the Medicaid eligible members under the employer-sponsored plan if DMAS determines it is cost effective to do so.

"Qualified employer-sponsored insurance" as defined under § 2105(c)(10)(B) of the Social Security Act means a group health plan or health insurance coverage offered through an employer:

1. That qualifies as creditable coverage as a group health plan under § 2701(c)(1) of the Public Health Service Act;

2. For which the employer contribution toward any premium for such coverage is at least 40%; and

3. That is offered to all individuals in a manner that would be considered a nondiscriminatory eligibility classification for purposes of § 105(h)(3)(A)(ii) of the Internal Revenue Code of 1986 without regard to § 105(h)(3)(B)(i).

"State Plan" means the State Plan for Medical Assistance for the Commonwealth of Virginia.

B. Program purpose. The purpose of the HIPP Program shall be to:

1. Enroll members who have qualified employer-sponsored insurance plans that are likely to be cost effective;

2. Provide premium assistance subsidy for payment of the employee share of the premiums and other cost-sharing obligations for items and services otherwise covered under the State Plan for Medical Assistance; and

3. Treat coverage under such qualified employer-sponsored insurance plan as a third-party liability consistent with § 1906 of the Social Security Act.

C. Cost effectiveness methodology.

1. DMAS shall evaluate the individual to determine the appropriate managed care organization (MCO) capitation rate to be used. The capitation rate will be determined based on aid category, nursing facility or waiver eligibility, age, gender, and region.

2. DMAS shall adjust the capitation rate to exclude Medicaid services that are not available through commercial group health insurance policies. This requires that the capitation rate be adjusted to exclude services, including nursing facility and long-term services and supports provided in the Commonwealth Coordinated Care (CCC) Plus program as well as community mental health services and nonemergency transportation services available in CCC Plus and Medallion.

3. DMAS shall adjust the reduced capitation rate from subdivision 2 of this subsection to reflect the higher prices employer plans pay. The Virginia price factor shall be based on the national factor of 1.3 that is published by the Centers for Medicare and Medicaid Services.

4. The qualified employer-sponsored insurance cost for the individual shall be increased to reflect the amount of coinsurance and other member cost sharing typically imposed on HIPP members and paid by DMAS. Such amount shall be determined by averaging the aggregate amount of such expenditures by DMAS in the most recently completed fiscal year by the number of HIPP members covered during the fiscal year.

5. The qualified employer-sponsored insurance plan cost determined in subdivision 4 of this subsection shall be increased to reflect the DMAS administrative expenses directly related to the HIPP program. This additional cost is determined based on the average total monthly compensation paid to each HIPP analyst employed by DMAS divided by the anticipated caseload.

6. The cost effectiveness shall be affirmed if the adjusted capitation rate from subdivision 3 of this subsection equals or exceeds the adjusted qualified employer-sponsored insurance plan cost from subdivision 5 of this subsection.

D. Member eligibility.

1. DMAS shall obtain specific information on all group health plans available to the recipients in the case including the effective date of coverage, the services covered by the plan, the deductibles and copayments required by the plan, the exclusions to the plan, and the amount of the premium. Coverage that is not comprehensive shall be denied premium assistance. A qualified employer-sponsored insurance plan must provide the following services in order to be considered comprehensive:

a. Physician services;

b. Inpatient and outpatient hospitalization;

c. Outpatient labs, shots, and x-rays; and

d. Prescription drugs.

2. All persons who are eligible for coverage under the qualified employer-sponsored insurance plan and who are eligible for Medicaid shall be eligible for consideration for HIPP, except those identified in subdivisions 2 a through 2 e of this subsection.

a. The recipient is Medicaid eligible due to "spenddown."

b. The recipient is currently enrolled in the qualified employee-sponsored insurance plan and is only retroactively eligible for Medicaid.

c. The recipient is in a nursing home or has a deduction from patient pay responsibility to cover the insurance premium.

d. Currently, Medicare beneficiaries who are enrolled in a MCO do not qualify for participation in the HIPP Program. If a Medicaid beneficiary is enrolled in an MCO, the beneficiary must wait until he is disenrolled from the MCO to become eligible for HIPP. HIPP applications are not approved until the managed care eligibility has ended at the end of the month.

e. The recipient is eligible for Medicare Part B but is not enrolled in Part B.

E. Application required. A completed HIPP application must be submitted to DMAS to be evaluated for HIPP program eligibility; if HIPP program eligibility is established, DMAS shall then evaluate the group health plan for cost effectiveness. The HIPP application consists of the forms prescribed by DMAS and any necessary information as required by the program to evaluate eligibility and perform a cost-effectiveness evaluation.

1. Effective date of premium assistance subsidy. Payment of premium assistance subsidy shall become effective on the first day of the month following the month in which DMAS approves the application and makes the cost effectiveness determination. Payment shall be made to either the employer, the insurance company, or to the individual who is carrying the group health plan coverage.

2. Termination date of premium assistance subsidy. Payment of premium assistance subsidy shall end on whichever of the following occurs the earliest:

a. On the last day of the month in which eligibility for Medicaid ends;

b. The last day of the month in which the recipient loses eligibility for coverage in the qualified employer-sponsored insurance plan; or

c. The last day of the month in which adequate notice has been given (consistent with federal requirements at 42 CFR 431.211) that DMAS has redetermined that the group health plan is no longer cost effective.

3. Non-Medicaid-eligible family members. Payment of premium assistance subsidy for non-Medicaid-eligible family members may be made when their enrollment in the qualified employer-sponsored insurance plan is required in order for the recipient to obtain the qualified employer-sponsored insurance plan coverage. Such payments shall be treated as payments for Medicaid benefits for the recipient. No payments for deductibles, coinsurances, and other cost-sharing obligations for non-Medicaid-eligible family members shall be made by DMAS.

4. Evidence of enrollment required. The payee to whom DMAS is paying the qualified employer-sponsored insurance plan premium assistance subsidy shall, as a condition of receiving such payment, provide to DSS or DMAS, upon request, written evidence of the payment of the employee's share of the plan premium for the qualified employer-sponsored insurance plan that DMAS determined to be cost effective.

F. Cost-sharing wrap.

1. Premium assistance enrollment is voluntary. Individuals enrolled in the HIPP program are afforded the same member protections provided to all other Medicaid enrollees. Cost sharing shall only be charged to Medicaid members as permitted under §§ 1916 and 1916A of the Social Security Act. Cost sharing shall not exceed 5.0% of household income.

2. The Commonwealth will provide a cost-sharing wrap to any cost-sharing amounts of a Medicaid covered service that exceeds the cost-sharing limits described in the State Plan, regardless of whether individuals enrolled in a HIPP program receive care from a Medicaid participating provider or a nonparticipating provider.

3. To effectuate the cost-sharing wrap, the Commonwealth will encourage nonparticipating providers to enroll by conducting targeted outreach to inform nonparticipating Medicaid providers on how to enroll in Medicaid for the purposes of receiving payment from the state for cost-sharing amounts that exceed the Medicaid permissible limits.

4. The Commonwealth will inform members regarding options available when the member obtains care from a nonparticipating provider, including, as applicable, reimbursement for out-of-pocket, cost-sharing costs from this provider.

5. In order to receive reimbursement, the individual shall submit to DMAS an explanation of benefits or similar documentation from the insurance company or doctor's office showing DOS, that the expense is the responsibility of the member or parent, that the expense was paid prior to the submission of the request, and sufficient identification codes for the DOS to enable DMAS to determine if the service is reimbursable before applying the remaining cost-sharing criteria.

6. Reimbursement for cost sharing shall be processed on a quarterly basis.

G. HIPP program participation requirements. Participants must comply with the following program requirements as prescribed by DMAS for continued enrollment in HIPP. Failure to comply shall result in termination from the program.

1. Submission of documentation of any change to the qualified employer-sponsored insurance plan, to include any changes to the employee share of the premium expense, within 10 days of receipt of notice of the change.

2. Any household change, including income and individuals in household, must be reported within 10 days of the change.

3. Completion of annual redetermination.

4. Completion of consent forms. Participants may be required to complete a consent form to release information necessary for HIPP participation and program requirements as required by DMAS.

H. HIPP redetermination. DMAS shall redetermine the cost effectiveness of the qualified employer-sponsored insurance plan periodically, and at least every 12 months. DMAS shall also redetermine cost effectiveness when changes occur with the recipient's average Medicaid cost or with the qualified employer-sponsored insurance plan information that was used in determining the cost effectiveness. When only part of the household loses Medicaid eligibility, DMAS shall redetermine the cost effectiveness to ascertain whether payment of the premium assistance subsidy of the qualified employer-sponsored insurance plan continues to be cost effective.

I. Multiple group health plans. When a member is eligible for more than one group health plan, DMAS shall perform the cost effectiveness determination on the group health plan in which the member is enrolled. If the member is not enrolled in a group health plan, DMAS shall perform the cost effectiveness determination on each group health plan available to the member.

J. Third-party liability. When recipients are enrolled in group health plans, these plans shall become the first sources of health care benefits, up to the limits of such plans, prior to the availability of Title XIX benefits.

K. Appeal rights. Applicants and members shall be given the opportunity to appeal adverse agency decisions consistent with agency regulations for client appeals (12VAC30-110-10 through 12VAC30-110-370).

L. Provider requirements. Providers shall be required to accept the greater of the group health plan's reimbursement rate or the Medicaid rate as payment in full and shall be prohibited from charging the recipient or Medicaid amounts that would result in aggregate payments greater than the Medicaid rate as required by 42 CFR 447.20.

M. Provider participation or enrollment. The Commonwealth will enroll network providers as full Medicaid providers or as fee-for-service Medicaid providers solely for the purpose of receiving cost sharing, similar to processes related to enrolling Medicare-participating providers that serve dually eligible members. If the state enrolls providers for the sole purpose of being reimbursed for cost sharing, the payee would make the decision to enroll knowing that the provider network would be the same as for other enrollees of the qualified employer-sponsored insurance. In either scenario, the member would never pay more than the permissible Medicaid copayment.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-02-4.2230, eff. April 1, 1993; amended, Virginia Register Volume 25, Issue 20, eff. July 23, 2009; Volume 29, Issue 2, eff. October 25, 2012; Volume 38, Issue 12, eff. March 17, 2022.

Part V Sanctions, Advance Directives

12VAC30-20-215 Sanctions for psychiatric hospitals

(a) The state assures that the requirements of § 1902(y)(1), § 1902(y)(2)(A), and § 1902(y)(3) of the Act are met concerning sanctions for psychiatric hospitals that do not meet the requirements of participation when the hospital's deficiencies immediately jeopardize the health and safety of its patients or do not immediately jeopardize the health and safety of its patients.

(b) The state terminates the hospital's participation under the State plan when the state determines that the hospital does not meet the requirements for a psychiatric hospital and further finds that the hospital's deficiencies immediately jeopardize the health and safety of its patients.

(c) When the state determines that the hospital does not meet the requirements for a psychiatric hospital and further finds that the hospital's deficiencies do not immediately jeopardize the health and safety of its patients, the state may:

1. Terminate the hospital's participation under the State plan; or

2. Provide that no payment will be made under the State plan with respect to any individual admitted to such hospital after the effective date of the finding; or

3. Terminate the hospital's participation under the State plan and provide that no payment will be made under the State plan with respect to any individual admitted to such hospital after the effective date of the finding.

(d) When the psychiatric hospital described in (c) above has not complied with the requirements for a psychiatric hospital within 3 months after the date the hospital is found to be out of compliance with such requirements, the state shall provide that no payment will be made under the State plan with respect to any individual admitted to such hospital after the end of such 3-month period.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-02-4.3000:1, eff. November 15, 1995.

12VAC30-20-220 Income and eligibility verification system procedures; requests to other state agencies

The Department of Medical Assistance Services will meet all of the applicable requirements of 42 CFR 431 Subparts A and F and 42 CFR 435 with respect to the Income and Eligibility Verification System.

In addition to the federal regulatory requirements, the additional information match against Virginia Department of Motor Vehicles will be made for new applicants and ongoing recipients of medical assistance.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-4.3210, eff. December 1, 1986.

12VAC30-20-230 Method for issuance of medicaid eligibility cards to homeless individuals

Permanent addresses are not required. Recipients are allowed to choose the method of receiving their Medicaid cards:

a) Mailing to General Delivery at a post office of their choice;

b) Picking up their card at the local department of social services;

c) An alternate mailing address with assurance of receipt of mail.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-4.3310, eff. July 1, 1987.

12VAC30-20-240 Requirements for advance directives under state plans for medical assistance

The following is a written description of the law of the State (whether statutory or as recognized by the courts of the State) concerning advance directives. If applicable States should include definitions of living will, durable power of attorney for health care, durable power of attorney, witness requirements, special State limitations on living will declarations, proxy designation, process information and State forms, and identify whether State law allows for a health care provider or agent of the provider to object to the implementation of advance directives on the basis of conscience.

1.0. All specified providers, receiving funds under this Plan, shall maintain written policies, procedures, and materials concerning advance directives to ensure compliance with the law. All providers must:

A. give written information to all adults (as defined by the Code of Virginia § 54.1-2981 et seq., receiving medical care concerning their rights under state law to:

1. Make decisions concerning their medical care,

2. Accept or refuse medical or surgical treatment, and

3. Formulate advance directives, e.g., living wills or durable powers of attorney for health care.

B. Provide written information to all adults on their policies concerning implementation of these rights;

C. Document in the individual's medical record whether he has executed an advance directive;

D. Not condition providing care or otherwise discriminate against an individual based on whether he has executed an advance directive;

E. Ensure compliance with the requirements of state law concerning advance directives; and

F. Provide for educating staff and the community on advance directives.

2.0. Providers shall give to each adult patient information concerning advance directives according to the following:

A. Hospitals shall provide such information at the time of the individual's admission as an inpatient.

B. Nursing facilities shall provide such information at the time of the individual's admission as a resident.

C. Providers of home health care or personal care services shall provide such information in advance of the individual's coming under the care of the provider.

D. Hospice programs shall provide such information at the time of the initial receipt of hospice care by the individual.

E. A health maintenance or health insuring organization shall provide such information at the time the individual enrolls or reenrolls with the organization. If such organization maintains more than one record for its enrollees, it must document all medical records.

3.0. Advance directives for incapacitated individuals. To the extent that a facility or provider issues materials about policies and procedures to the families or surrogates or other concerned persons of the incapacitated patient in accordance with state law, the facility or provider shall also provide information concerning advance directives. Such provision of information to families or surrogates shall not relieve the facility or provider of the requirement to provide this information to the patient once he is no longer incapacitated.

4.0. Previously executed advance directives. When the patient or a relative, surrogate or other concerned or related individual presents the facility or provider with a copy of the individual's advance directive, the facility or provider must comply with the advance directive including recognition of the power of attorney, to the extent allowed under state law. Absent contrary state law, if no one comes forward with a previously executed advance directive and the patient is incapacitated or otherwise unable to receive information or articulate whether he has executed an advance directive, the facility or provider must note in the individual's medical record that the individual was not able to receive such information and was unable to communicate whether an advance directive existed.

5.0. Conscientious objection by providers. Nothing in this section shall be construed to prohibit the application of a state law which allows for an objection on the basis of conscience for any health care provider or any agent of such provider which as a matter of conscience cannot implement an advance directive.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-4.3410, eff. June 16, 1993.

12VAC30-20-249 (Repealed.)

Historical Notes

Derived from VR460-02-5.3510 and VR460-02-4.3510, eff. July 4, 1990; repealed, Virginia Register Volume 12, Issue 25, eff. October 2, 1996.

Part VI Nursing Facility Enforcement

12VAC30-20-251 Termination of provider agreement

A. Mandatory termination. As set forth by 42 CFR 488.408 (1995), the Commonwealth shall (i) impose temporary management on the nursing facility; (ii) terminate the nursing facility's provider agreement; or (iii) impose both of these remedies when there are one or more deficiencies that constitute immediate jeopardy to resident health or safety. In addition, the Commonwealth shall terminate the nursing facility's provider agreement when the nursing facility fails to relinquish control to the temporary manager, or in situations when a facility's deficiencies do not pose immediate jeopardy, if the nursing facility does not meet the eligibility criteria for continuation of payment set forth in 42 CFR 488.412(a) (1995).

B. The Commonwealth shall have the authority to terminate a nursing facility's provider agreement if such nursing facility:

1. Is not in substantial compliance with the requirements of participation, regardless of whether or not immediate jeopardy is present; or

2. Fails to submit an acceptable plan of correction within the timeframe specified by the Commonwealth. For purposes of this section, substantial compliance shall be defined as meaning a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm.

C. Situations without immediate jeopardy. If a nursing facility's deficiencies do not pose immediate jeopardy to residents' health or safety, and the facility is not in substantial compliance, the Commonwealth shall have the authority to terminate the nursing facility's provider agreement or allow the nursing facility to continue to participate for no longer than six months from the last day of the survey agency's survey if:

1. The survey agency finds that it is more appropriate to impose alternative remedies than to terminate the nursing facility's provider agreement;

2. The Commonwealth has submitted a plan and timetable for corrective action approved by HCFA; and

3. The facility in the case of a Medicare skilled nursing facility or Commonwealth in the case of a Medicaid nursing facility agrees to repay to the federal government payments received after the last day of the survey that first identified the deficiencies if corrective action is not taken in accordance with the approved plan of correction.

D. Effect of termination. Termination of the provider agreement shall end payment to the nursing facility.

E. Patient transfer. The Commonwealth shall provide for the safe and orderly transfer of residents when the facility's provider agreement is terminated.

F. Continuation of payments to a facility with deficiencies. As set forth by 42 CFR 488.450:

1. The Commonwealth shall have the authority to terminate the nursing facility's provider agreement before the end of the correction period if the following criteria are not met: (i) the survey agency finds that it is more appropriate to impose alternative remedies than to terminate the nursing facility's provider agreement; (ii) the Commonwealth has submitted a plan and timetable for corrective action which has been approved by HCFA; and (iii) the Commonwealth has agreed to repay the federal government payments received under this provision if corrective action is not taken in accordance with the approved plan and timetable for corrective action.

2. Cessation of payments. If termination is not sought, either by itself or with another remedy or remedies, or any of the criteria of subdivision 1 of this subsection are not met or agreed to by either the facility or the Commonwealth, the facility or the Commonwealth shall receive no federal Medicaid payments, as applicable, from the last day of the survey.

3. Period of continued payments. If the criteria of subdivision 1 of this subsection are met, HCFA may continue payments to the Commonwealth for a Medicaid facility with noncompliance that does not constitute immediate jeopardy for up to six months from the last day of the survey. If the facility does not achieve substantial compliance by the end of this six-month period, the Commonwealth shall have the authority to terminate its provider agreement.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 25, eff. October 2, 1996.

12VAC30-20-252 Temporary management

A. Temporary management in cases of immediate jeopardy. In accordance with 42 CFR 488.408 (1995) and 42 CFR 488.410 (1995), the Commonwealth shall (i) impose temporary management on the nursing facility; (ii) terminate the nursing facility's provider agreement; or (iii) impose both of these remedies when there are one or more deficiencies that constitute immediate jeopardy to resident health or safety. For purposes of this section, temporary management shall mean the temporary appointment by HCFA or the Commonwealth of a substitute facility manager or administrator with authority to hire, terminate, or reassign staff, obligate nursing facility funds, alter nursing facility procedures, and manage the nursing facility to correct deficiencies identified in the nursing facility's operation. The individual appointed as a temporary manager shall meet the qualifications of 42 CFR 488.415(b) (1995) and be compensated in accordance with the requirements of 42 CFR 488.415(c) (1995). The Commonwealth shall notify the facility that a temporary manager is being appointed. In situations of immediate jeopardy, the Commonwealth shall also have the authority to impose other remedies, as appropriate, in addition to termination of the provider agreement and temporary management. In a nursing facility or dually participating facility, if the Commonwealth finds that such nursing facility's or facility's noncompliance poses immediate jeopardy to resident health or safety, the Commonwealth shall notify HCFA of such finding.

B. Temporary management in situations of no immediate jeopardy. When there are widespread deficiencies that constitute actual harm that is not immediate jeopardy, the Commonwealth shall have the authority to impose temporary management in addition to the remedies of denial of payment for new admissions or civil money penalties of $50 to $3,000 per day.

C. Failure to relinquish authority to temporary management.

1. Termination of provider agreement. If a nursing facility fails to relinquish authority to the temporary manager, the Commonwealth shall terminate the nursing facility's provider agreement within 23 calendar days of the last day of the survey if the immediate jeopardy is not removed. If the facility fails to relinquish control to the temporary manager, state monitoring may be imposed pending termination of the provider agreement. If the facility relinquishes control to the temporary manager, the Commonwealth must notify the facility that, unless it removes the immediate jeopardy, its provider agreement shall be terminated within 23 calendar days of the last day of the survey. A nursing facility's failure to pay the salary of the temporary manager shall be considered a failure to relinquish authority to temporary management.

2. Duration of temporary management. Temporary management shall end when any of the conditions specified in 42 CFR 488.454(c) (1995) are met. For purposes of this section, substantial compliance shall mean a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 25, eff. October 2, 1996; amended, Virginia Register Volume 13, Issue 1, eff. October 30, 1996.

12VAC30-20-253 Denial of payment for new admissions

A. Denial of payment for new admissions. The Commonwealth shall (i) deny payment for new admissions; (ii) impose civil money penalties of $50 to $3,000 per day; or (iii) impose both of these remedies when there are widespread deficiencies that constitute no actual harm with a potential for more than minimal harm but not immediate jeopardy, or one or more deficiencies that constitute actual harm that is not immediate jeopardy. As set forth by 42 CFR 488.417 (1995), the Commonwealth shall deny payment for new admissions when a nursing facility is not in substantial compliance three months after the last day of the survey identifying the noncompliance, or the survey agency has cited a nursing facility with substandard quality of care on the last three consecutive standard surveys. As set forth by 42 CFR 488.417, the Commonwealth shall have the authority to deny payment for all new admissions when a facility is not in substantial compliance. For the purposes of this section, a new admission shall be defined as a resident who is admitted to the facility on or after the effective date of a denial of payment remedy and, if previously admitted, has been discharged before that effective date. Residents admitted before the effective date of the denial of payment, and taking temporary leave, are not considered new admissions, nor subject to the denial of payment. Also for the purposes of this section, substantial compliance shall mean a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm.

B. Denial of payment for substandard quality of care on last three surveys. As set forth by 42 CFR 488.414 and 42 CFR 488.417 (1995), if a facility is found to have provided substandard quality of care on the last three consecutive standard surveys, regardless of other remedies provided, the Commonwealth shall deny payment for all new admissions and shall impose state monitoring until such facility demonstrates to the satisfaction of the Commonwealth that it is in substantial compliance with all requirements and will remain in substantial compliance with all requirements.

C. The Commonwealth shall have the authority to deny payment for new admissions for any deficiency except when the facility is in substantial compliance.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 25, eff. October 2, 1996.

12VAC30-20-254 Civil money penalty

A. Immediate jeopardy. In situations of immediate jeopardy, the Commonwealth shall have the authority to impose (in accordance with 42 CFR 488.430 through 42 CFR 488.444) a civil money penalty in the range of $3,050 to $10,000 in addition to the remedies of imposing temporary management or terminating the nursing facility's provider agreement. In imposing civil money penalties, the Commonwealth shall comply with all provisions of 42 CFR 488.430 through 488.444 (1995).

B. No immediate jeopardy. In accordance with 42 CFR 488.430 through 42 CFR 488.444, the Commonwealth shall (i) deny payment for new admissions; (ii) impose civil money penalties of $50 to $3,000 per day; or (iii) impose both of these remedies when there are widespread deficiencies that constitute no actual harm with a potential for more than minimal harm but not immediate jeopardy, or one or more deficiencies that constitute actual harm that is not immediate jeopardy.

C. Notice. Either HCFA or the Commonwealth, as appropriate, shall send a prior written notice of the penalty to the facility as set forth by 42 CFR 488.434 (1995).

D. The Commonwealth shall have the authority to impose civil money penalties of $50 to $3,000 per day to any deficiency except when the nursing facility is in substantial compliance. If the Commonwealth imposes a civil money penalty for a deficiency that constitutes immediate jeopardy, the penalty must be in the range of $3,050 to $10,000 per day. For the purposes of this section, substantial compliance shall mean a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 25, eff. October 2, 1996.

12VAC30-20-255 State monitoring

A. In accordance with 42 CFR 488.422 (1995), the Commonwealth shall directly monitor the delivery of services for nursing facilities to have isolated deficiencies that constitute no actual harm with a potential for more than minimal harm but not immediate jeopardy, or found to have a pattern of deficiencies that constitute no actual harm with a potential for more than minimal harm but not immediate jeopardy. As set forth by 42 CFR 488.408(c)(3) (1995), the Commonwealth shall have the authority to impose state monitoring at any time to any deficiency except when the facility is in substantial compliance. As set forth by 42 CFR 488.414 (1995), if a facility is found to have provided substandard quality of care on the last three consecutive standard surveys, regardless of other remedies provided, the Commonwealth shall deny payment for all new admissions and shall impose state monitoring as specified in 42 CFR 488.422 until such facility demonstrates to the satisfaction of the Commonwealth that it is in substantial compliance with all requirements and will remain in substantial compliance with all requirements. For purposes of this section, a new admission shall be defined as a resident who is admitted to the facility on or after the effective date of a denial of payment remedy and, if previously admitted, has been discharged before that effective date. Residents admitted before the effective date of the denial of payment, and taking temporary leave, are not considered new admissions, nor subject to the denial of payment. For the purposes of this section, substantial compliance shall mean a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm.

B. For state monitoring, no prior notice shall be required of the Commonwealth to the nursing facility.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 25, eff. October 2, 1996.

12VAC30-20-256 Transfer of residents; transfer of residents with closure of facility

A. The Commonwealth shall arrange for the safe and orderly transfer of Medicare and Medicaid nursing facility residents when the provider agreement with the nursing facility is terminated.

B. In an emergency, the Commonwealth shall have the authority to transfer Medicare and Medicaid residents to another facility, or close the facility and transfer the Medicare and Medicaid residents to another facility.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 25, eff. October 2, 1996.

12VAC30-20-257 Required plan of correction

A. In accordance with 42 CFR 488.408(f) (1995), a nursing facility found to have a deficiency with regard to a program requirement shall submit a plan of correction for approval by the Commonwealth without regard to the remedies which are imposed or the seriousness of the identified deficiencies. A nursing facility shall not be required to submit a plan of correction when it has been found to have deficiencies that are isolated that the Commonwealth determines have only a potential for minimal harm but no actual harm has occurred.

B. For the purposes of this section, a plan of correction shall mean a plan developed by the nursing facility or the appointed temporary manager and approved by HCFA or the state survey agency that describes the actions the nursing facility will take to correct deficiencies and specifies the date by which those deficiencies will be corrected.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 25, eff. October 2, 1996.

12VAC30-20-258 Appeals

A. Nursing facility appeal rights. As set forth by 42 CFR 488.408(g) (1995), a nursing facility for which deficiencies have been identified may appeal a certification of noncompliance leading to an enforcement remedy.

B. Appeal limits. As set forth by 42 CFR 488.408(g) (1995), nursing facilities may not appeal the Commonwealth's choice of the remedy to be applied, including the factors considered by the Commonwealth or HCFA in selecting the remedy specified in 42 CFR 488.404.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 25, eff. October 2, 1996.

12VAC30-20-259 Repeated substandard quality of care

Any remedies or sanctions which may be imposed by the Commonwealth pursuant to 42 CFR 488.414(a) shall be imposed in accordance with the requirements set forth by 42 CFR 488.414(b) through 488.414(e) and 488.454(b).

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 25, eff. October 2, 1996.

Part VII Specialized Services; Categorical Determinations

12VAC30-20-260 Definition of specialized services

The Department of Medical Assistance Services (DMAS) shall define specialized services for the purposes of preadmission screening and annual resident review as follows. The Department of Behavioral Health and Developmental Services shall ensure the provision of services when they are provided by a non-Medicaid-enrolled provider or when the services are not covered by Medicaid.

a. Partial hospitalization;

b. Transportation to Medicaid-covered services or specialized services necessary to treat conditions of mental illness or intellectual disabilities;

c. Day health and rehabilitation;

d. Psychosocial rehabilitation;

e. Crisis intervention;

f. Customized durable medical equipment, for residents without a patient pay, that would allow the resident to participate in specialized services;

g. Behavior management interventions requiring ongoing consultation and monitoring by a licensed psychiatrist or psychologist;

h. One-to-one supervision necessary for behavior management;

i. Vision and hearing needs related to mental illness or intellectual disabilities for persons older than 21 years of age;

j. Dental needs resulting from mental illness or intellectual disabilities sequela for persons older than 21 years of age;

k. Habilitation;

l. Supported employment for persons with mental illness or intellectual disabilities;

m. Case management services;

n. Individual psychotherapy;

o. Day treatment;

p. Individual and group counseling; and

q. Inpatient psychiatric care.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-3900, eff. June 1, 1993; amended, Virginia Register Volume 42, Issue 11, eff. February 11, 2026.

12VAC30-20-270 Categorical determinations

1. A Level II evaluation shall be required for any applicant to a Medicaid-certified nursing facility who is determined, as a result of the Level I identification screening, to have a condition of mental illness or intellectual disability as defined in 42 CFR 483.102.

2. If, however, the individual also meets one of the categorical determinations in subdivision 3 of this section, a Level II evaluation is not required to be completed for that individual. These determinations may only be applied following the Level I review and only if existing data on the individual appear to be current and accurate and are sufficient to allow the evaluator readily to determine that the individual fits into the established category.

3. The categorical determinations are:

a. A terminal illness in which a physician has documented that life expectancy is less than six months; and

b. A severe physical illness, such as coma, functioning at brain stem level, or other conditions that result in a level of impairment so severe that the individual could not be expected to benefit from active treatment. When this category is used, documentation must be available that fully describes the severity of the condition.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-4.3910, eff. June 1, 1993; amended, Virginia Register Volume 42, Issue 11, eff. February 11, 2026.

Part VIII Nursing Facilities Survey/Certification

12VAC30-20-272 Survey and certification education program

The state has in effect the following survey and certification periodic education program for the staff and residents (and their representatives) of nursing facilities in order to present current regulations, procedures, and policies.

The state survey agency periodically conducts provider training programs and orientation of OBRA regulations and the survey process through programs or mailings. The state survey agency participates in the Medicaid agency's training of facilities regarding the Resident Assessment Instrument.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-02-4.40100, eff. November 15, 1995.

12VAC30-20-274 Process for the investigation of allegations of resident neglect and abuse and misappropriation of resident property

The state has in effect the following process for the receipt and timely review and investigation of allegations of neglect and abuse and misappropriation of resident property by a nurse aide or a resident in a nursing facility or by another individual used by the facility in providing services to such a resident.

When the above described incidences involve a nurse aide, they are reported to the Board of Health Professions, Board of Nursing. In addition, such allegations are frequently received by the facility administration which reports the allegations to the state survey agency. The state survey agency conducts the follow-up investigations.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-02-4.40200, eff. November 15, 1995.

12VAC30-20-275 Procedures for scheduling and conduct of standards surveys

The state has in effect the following procedures for the scheduling and conduct of standard surveys to assure that it has taken all reasonable steps to avoid giving notice.

Onsite survey schedules are only accessible to staff of the Department of Health, Division of Licensure and Certification, which conducts the surveys. After the onsite review is initiated by the Division inspection staff, the Virginia Department of Health notifies the state agency for the aging ombudsman, the state fire marshal, and other agencies as needed.

History

• Statutory Authority: § 32.1.325 of the Code of Virginia.
• Historical Notes: Derived from VR460-02-4.40300, eff. November 15, 1995.

12VAC30-20-277 Programs to measure and reduce inconsistency

The state has in effect the following programs to measure and reduce inconsistency in the application of survey results among surveyors.

The state survey agency conducts routine training programs, routine informational memorandums and procedural clarifications, routine team meetings, and ongoing supervisory review and monitoring of staff training needs.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-02-4.40400, eff. November 15, 1995.

12VAC30-20-278 Process for investigations of complaints and monitoring

A. The state has in effect the following process for investigating complaints of violations of requirements by nursing facilities and monitors onsite on a regular, as needed basis, a nursing facility's compliance with the requirements of § 1919(b), (c), and (d) for the following reasons:

(i) The facility has been found not to be in compliance with such requirements and is in the process of correcting deficiencies to achieve such compliance;

(ii) The facility was previously found not to be in compliance with such requirements and has corrected deficiencies to achieve such compliance, and verification of continued compliance is indicated; or

(iii) The state has reason to question the compliance of the facility with such requirements.

B. All complaints are investigated by the Virginia Department of Health, Office of Health Facilities Regulation, per nature of the complaint.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-02-4.40500, eff. November 15, 1995.

Part IX Administration, Civil Rights

12VAC30-20-280 Methods of administration; civil rights

A statement of compliance (Form CB-FS 5022) and the State Agency's method of implementing administration in the Medical Assistance Program, which was submitted to the Department of Health, Education, and Welfare on November 30, 1967, are certified to be applicable to this State Plan.

The Methods of Administration for Title VI as initially furnished by the State Agency in 1965 in conformity with the requirements of Title VI of the Civil Rights Act of 1964, along with the agreements subsequently negotiated with the Office of Civil Rights in 1969 provide the working basis for the State Agency's administration of its compliance responsibilities under Title VI. This Plan provides for on site reviews of all vendor facilities, including facilities used under Title XIX, to be conducted annually to assure compliance with Title VI. This all programs operated by the Virginia Health Department (and by other State Agencies) are being and will be conducted in such a manner that no person will be excluded from participation in, be denied the benefits of, or be otherwise subjected to discrimination on the ground of race, color, or national origin.

For all employees under the Medical Assistance Program, assurance is made that equal opportunity practices will exist in conformance with the requirements of Federal law, Title VII, Civil Rights Act of 1964. An Equal Employment Opportunity Plan was directed by State Executive order number twenty-nine to be applicable policy effective January 1, 1973, governing State personnel administration. Copies of this Plan were submitted to the Department of Health, Education, and Welfare, of the U.S. government. By directive of the Commissioner of Health, affirmative action on this Plan was directed on all levels of management of the Department of Health of Virginia and thereby on all employees of the State's Medical Assistance Program.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-7.2100, eff. July 1, 1987.

Part X [Reserved] Part XI [Reserved]

12VAC30-20-290 [Reserved]

Part XI [Reserved]

Part XII Provider Appeals

12VAC30-20-500 Definitions

The following words and terms when used in this part shall have the following meanings:

"Administrative dismissal" means a dismissal that requires only the issuance of a decision with appeal rights but does not require the submission of a case summary or any further proceeding.

"Day" means a calendar day unless otherwise stated.

"DMAS" means the Virginia Department of Medical Assistance Services or its agents or contractors.

"Hearing officer" means an individual selected by the Executive Secretary of the Supreme Court of Virginia to conduct the formal appeal in an impartial manner pursuant to §§ 2.2-4020 and 32.1-325.1 of the Code of Virginia and this part.

"Informal appeals agent" means a DMAS employee who conducts the informal appeal in an impartial manner pursuant to §§ 2.2-4019 and 32.1-325.1 of the Code of Virginia and this part.

"Last known address" means the provider's physical or electronic correspondence address on record in the DMAS Medicaid Enterprise System (MES) as of the date DMAS transmits an item to the provider or the address of the provider's counsel of record. Nothing herein shall prevent DMAS and the provider from agreeing in writing during the course of an audit or an appeal to use an alternative location for the transmittal of an item or items related to the audit or the appeal.

"Provider" means an individual or entity that has a contract with DMAS to provide covered services and that is not operated by the Commonwealth of Virginia.

"Transmit" means to send by means of the United States mail, courier or other hand delivery, facsimile, electronic mail, or electronic submission.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 19, eff. July 4, 2001; amended, Virginia Register Volume 25, Issue 14, eff. April 15, 2009; Volume 32, Issue 23, eff. August 10, 2016; Volume 42, Issue 20, eff. June 17, 2026.

12VAC30-20-510 [Reserved]

Historical Notes

Derived from Volume 17, Issue 19, eff. July 4, 2001.

12VAC30-20-520 Provider appeals: general provisions

A. This part governs all DMAS informal and formal provider appeals and supersedes any other provider appeals regulations.

B. A provider may appeal any DMAS action that is subject to appeal under the Virginia Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia), including the DMAS interpretation and application of payment methodologies. A provider may not appeal the actual payment methodologies.

C. DMAS shall transmit all items to the last known address of the provider. It is presumed that DMAS transmits items on the date noted on the item. It is presumed that providers receive items transmitted by United States mail to their last known address within three days after DMAS transmits the item by United States mail. It is presumed that providers receive items transmitted by facsimile, email, or other electronic submission on the date transmitted. It is presumed that providers receive items transmitted by courier or other hand delivery on the date of delivery to the provider's last known address. These presumptions in this section shall apply unless the provider, through evidence beyond a mere denial of receipt, introduces evidence sufficient to rebut the presumption. If a provider requests a copy of an item, the transmittal date for the item remains the date originally noted on the item, and not the date that the copy of the requested item is transmitted. A provider's failure to accept delivery of an item transmitted by DMAS, or a provider's failure to open an item upon receipt, shall not result in an extension of any of the timelines established by this part.

D. Whenever DMAS or a provider is required to file a document, the document shall be considered filed when it is date-stamped by the DMAS Appeals Division. When DMAS or a provider is using the online appeals portal administered by the DMAS Appeals Division, the date stamp will be automatically applied when the item completes transmission to the Appeals Division. When email or facsimile is used, the date stamp will be reflected on the date and time of the transmission. If other means are used, such as postal mail or hand delivery, the date stamp will be applied physically by the DMAS Appeals Division upon receipt.

E. Whenever the last day specified for the filing of any document or the performance of any other act falls on a day on which DMAS is officially closed for the full or partial day, the time period shall be extended to the next day on which DMAS is officially open.

F. Conferences and hearings shall be conducted at the DMAS main office in Richmond, Virginia, or at such other place as agreed upon in writing by DMAS, the provider, and the informal appeals agent for informal appeals. For formal appeals, this agreement shall be between DMAS, the provider, and the hearing officer.

G. Whenever DMAS or a provider is required to attend a conference or hearing, failure by one of the parties to attend the conference or hearing shall result in dismissal of the appeal in favor of the other party.

H. DMAS shall reimburse a provider for reasonable and necessary attorney fees and costs associated with an informal or formal appeal if the provider substantially prevails on the merits of the appeal and the DMAS position is not substantially justified, unless special circumstances would make an award unjust. In order to substantially prevail on the merits of the appeal, the provider must be successful on more than 50% of the dollar amount involved in the issues identified in the provider's notice of appeal.

I. Any document that is filed with the DMAS Appeals Division after 5 p.m. Eastern Time shall be date-stamped on the next day DMAS is officially open. Any document that is filed with the DMAS Appeals Division after 5 p.m. Eastern Time on the due date shall be untimely.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 19, eff. July 4, 2001; amended, Virginia Register Volume 25, Issue 14, eff. April 15, 2009; Volume 32, Issue 23, eff. August 10, 2016; Volume 40, Issue 22, eff. August 1, 2024.

12VAC30-20-530 [Reserved]

Historical Notes

Derived from Volume 17, Issue 19, eff. July 4, 2001.

12VAC30-20-540 Informal appeals

A. Notice of informal appeal.

1. Providers appealing the termination or denial of their Medicaid agreement pursuant to § 32.1-325 E of the Code of Virginia shall file a written notice of informal appeal with the DMAS Appeals Division within 15 days of the provider's receipt of the notice of termination or denial.

2. Providers appealing adjustments to a cost report shall file a written notice of informal appeal with the DMAS Appeals Division within 90 days of the provider's receipt of the notice of program reimbursement. The written notice of informal appeal shall identify the issues, adjustments, or items that the provider is appealing.

3. Providers appealing all other DMAS decisions shall file a written notice of informal appeal with the DMAS Appeals Division within 30 days of the provider's receipt of the decision. The written notice of informal appeal shall identify each adjustment, patient, service date, or other disputed matter that the provider is appealing.

B. Administrative dismissals.

1. Failure to timely file a written notice of informal appeal with the information required by subdivision A 2 or A 3 of this section shall result in an administrative dismissal.

2. A representative, billing company, or other third-party entity filing a written notice of appeal on behalf of a provider shall submit to DMAS, at the time of filing or upon request, a written authorization to act on the provider's behalf, signed by the provider. The authorization shall reference the specific adverse action being appealed including, if applicable, each patient's name and date of service. Failure to submit a written authorization as specified in this subdivision shall result in an administrative dismissal. This requirement shall not apply to an appeal filed by a Virginia licensed attorney.

3. If a provider has not exhausted any applicable DMAS or contractor reconsideration or review process or contractor's internal appeals process that the provider is required to exhaust before filing a DMAS informal appeal, the provider's written notice of informal appeal shall be administratively dismissed.

4. If DMAS has not issued a decision with appeal rights, the provider's attempt to file a written notice of informal appeal, prior to the issuance of a decision by DMAS that has appeal rights, shall be administratively dismissed.

C. Written case summary.

1. DMAS shall file a written case summary with the DMAS Appeals Division within 30 days of the filing of the provider's notice of informal appeal and shall transmit a complete copy of the case summary to the provider on the same day.

2. For each adjustment, patient, and service date or other disputed matter identified by the provider in its notice of informal appeal, the case summary shall explain the factual basis upon which DMAS relied in taking its action or making its decision and identify any authority or documentation upon which DMAS relied in taking its action or making its decision.

3. Failure to file a written case summary with the DMAS Appeals Division within 30 days of the filing of the written notice of informal appeal shall result in dismissal in favor of the provider.

4. The provider shall have 12 days following the due date of the case summary to file with the DMAS Appeals Division and transmit to the author of the case summary a written notice of all alleged deficiencies in the case summary that the provider knows, or reasonably should know, exist. Failure of the provider to timely file a written notice of deficiency with the DMAS Appeals Division shall be deemed a waiver of all deficiencies, alleged or otherwise, with the case summary.

5. Upon timely receipt of the provider's notice of deficiency, DMAS shall have 12 days to address the alleged deficiency. If DMAS does not address the alleged deficiency or does not address the alleged deficiency to the provider's satisfaction, the alleged deficiency shall become an issue to be addressed by the informal appeals agent as part of the informal appeal decision.

6. The informal appeals agent shall make a determination as to each deficiency that is alleged by the provider as set forth in this subsection. In making that determination, the informal appeals agent shall determine whether the alleged deficiency is such that it could not reasonably be determined from the case summary the factual basis and authority for the DMAS action, relating to the alleged deficiency, so as to require a dismissal in favor of the provider on the issue to which the alleged deficiency pertains.

D. Conference.

1. The informal appeals agent shall conduct the conference within 90 days from the filing of the notice of informal appeal. If DMAS, the provider, and the informal appeals agent agree, the conference may be conducted by way of written submissions. If the conference is conducted by way of written submissions, the informal appeals agent shall specify the time within which the provider may file written submissions, not to exceed 90 days from the filing of the notice of informal appeal. Only written submissions filed within the time specified by the informal appeals agent shall be considered.

2. The conference may be recorded at the discretion of the informal appeals agent and solely for the convenience of the informal appeals agent. Because the conference is not an adversarial or evidentiary proceeding, no other recordings or transcriptions shall be permitted. Any recordings made for the convenience of the informal appeals agent shall not be released to DMAS or to the provider.

3. Upon completion of the conference, the informal appeals agent shall specify the time within which the provider may file additional documentation or information, if any, not to exceed 30 days. Only documentation or information filed within the time specified by the informal appeals agent shall be considered.

E. Informal appeals decision. The informal appeal decision shall be issued within 180 days of receipt of the notice of informal appeal unless the provider and DMAS have mutually agreed in writing to stay the timeframe for issuing the informal decision pursuant to 12VAC30-20-550.

F. Remand. Whenever an informal appeal is required pursuant to a remand by court order, final agency decision, agreement of the parties, or otherwise, all time periods set forth in this section shall begin to run effective with the date that the document containing the remand is date-stamped by the DMAS Appeals Division in Richmond, Virginia.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 19, eff. July 4, 2001; amended, Virginia Register Volume 27, Issue 23, eff. August 17, 2011; Volume 32, Issue 23, eff. August 10, 2016; Volume 37, Issue 24, eff. September 2, 2021.

12VAC30-20-550 Settlement agreements

A. Providers who have filed an administrative appeal under 12VAC30-20-540 or 12VAC30-20-560 may submit a proposal to DMAS to settle the appeal.

B. A proposal for a settlement shall be submitted in writing by the provider or the provider's counsel to the DMAS Appeals Division Director. The proposal shall include the justification for the settlement and the terms proposed to settle the case. The Appeals Division Director shall refer the proposal to a DMAS appeal representative authorized by the Office of the Attorney General under § 2.2-509 of the Code of Virginia to represent DMAS in administrative proceedings.

C. Stay of decision deadlines.

1. Receipt of a settlement proposal from a provider in accordance with subsection B of this section shall not require the DMAS appeal representative to engage in settlement negotiations or agree to stay the deadline for the informal appeal decision or for the formal appeal recommended decision of the hearing officer (collectively, the decision deadline). The DMAS appeal representative and the provider may jointly agree in writing to stay the decision deadline for a period of up to 60 days to facilitate settlement discussions. The date of the written agreement of the parties to stay the decision deadline shall be the start date for calculating the length of the stay. Written notice of the agreement to stay the decision deadline and the length of stay shall be provided to the Appeals Division Director on the start date. During the stay, the time period to issue the informal appeal decision or the formal appeal recommended decision shall not run; however, all other interim deadlines remain applicable.

2. If the parties mutually agree in writing to a proposed resolution within the agreed upon stay period described in subdivision C 1 of this section, then the stay shall be extended for such additional time as may be necessary for review and approval of the settlement in accordance with § 2.2-514 of the Code of Virginia.

3. A stay may be removed by a party to the appeal for any reason, including the following:

a. The parties do not agree to a full settlement within the agreed upon stay period described in subdivision C 1 of this section;

b. One party advises the other and the Appeals Division Director in writing that it no longer agrees for the stay to continue; or

c. The parties reach a proposed settlement, but the proposed settlement is not approved in accordance with § 2.2-514 of the Code of Virginia.

If the stay is removed, the stay shall be communicated in writing between the parties and written notice provided to the Appeals Division Director. The time period to issue the informal appeal decision or the formal appeal recommended decision shall resume on the day the notice is provided to the Appeals Division Director.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 19, eff. July 4, 2001; amended, Virginia Register Volume 37, Issue 24, eff. September 2, 2021.

12VAC30-20-560 Formal appeals

A. A provider appealing a DMAS informal appeal decision shall file a written notice of formal appeal with the DMAS Appeals Division within 30 days of the provider's receipt of the informal appeal decision. The notice of formal appeal shall identify each adjustment, patient, service date, or other disputed matter that the provider is appealing. Failure to file a written notice of formal appeal in the detail specified within 30 days of receipt of the informal appeal decision shall result in dismissal of the appeal. Pursuant to § 2.2-4019 A of the Code of Virginia, DMAS shall ascertain the fact basis for decisions through informal proceedings unless the parties consent in writing to waive such a conference or proceeding to go directly to a formal hearing, and therefore only issues that were addressed pursuant to § 2.2-4019 of the Code of Virginia shall be addressed in the formal appeal, unless DMAS and the provider consent to waive the informal fact-finding process under § 2.2-4019 A of the Code of Virginia.

B. Documentary evidence, objections to documentary evidence, opening briefs, and reply briefs.

1. Documentary evidence, objections to documentary evidence, opening briefs, and reply briefs shall be filed with the DMAS Appeals Division on the date specified in this subsection. The hearing officer shall only consider those documents or pleadings that are filed within the required timeline. Simultaneous with filing, the filing party shall transmit a copy to the other party and to the hearing officer.

a. All documentary evidence upon which DMAS or the provider relies shall be filed within 21 days of the filing of the notice of formal appeal.

b. Any objections to the admissibility of documentary evidence shall be filed within seven days of the filing of the documentary evidence. The hearing officer shall rule on any such objections within seven days of the filing of the objections.

c. The opening brief shall be filed by DMAS and the provider within 30 days of the completion of the hearing.

d. Any reply brief from DMAS or the provider shall be filed within 10 days of the filing of the opening brief to which the reply brief responds.

2. If there has been an extension to the time for conducting the hearing pursuant to subsection C of this section, the hearing officer is authorized to alter the due dates for filing opening and reply briefs to permit the hearing officer to be in compliance with the due date for the submission of the recommended decision as required by § 32.1-325.1 B of the Code of Virginia and subsection E of this section.

C. The hearing officer shall conduct the hearing within 45 days from the filing of the notice of formal appeal, unless the hearing officer, DMAS, and the provider all mutually agree to extend the time for conducting the hearing. Notwithstanding the foregoing, the due date for the hearing officer to submit the recommended decision to the DMAS director, as required by § 32.1-325.1 B of the Code of Virginia and subsection E of this section, shall not be extended or otherwise changed.

D. Hearings shall be transcribed by a court reporter retained by DMAS.

E. The hearing officer shall submit a recommended decision to the DMAS director with a copy to the provider within 120 days of the filing of the formal appeal notice, unless the provider and DMAS have mutually agreed in writing to stay the timeframe for issuing the recommended decision pursuant to 12VAC30-20-550. If the hearing officer does not submit a recommended decision within 120 days of the filing of the notice of formal appeal or the period specified under 12VAC30-20-550, then DMAS shall give written notice to the hearing officer and the Executive Secretary of the Supreme Court that a recommended decision is due.

F. Upon receipt of the hearing officer's recommended decision, the DMAS director shall notify DMAS and the provider in writing that any written exceptions to the hearing officer's recommended decision shall be filed with the DMAS Appeals Division within 14 days of receipt of the DMAS director's letter. Only exceptions filed within 14 days of receipt of the DMAS director's letter shall be considered.

G. The DMAS director shall issue the final agency decision within 60 days of receipt of the hearing officer's recommended decision in accordance with § 32.1-325.1 B of the Code of Virginia.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 19, eff. July 4, 2001; amended, Virginia Register Volume 32, Issue 23, eff. August 10, 2016; Volume 37, Issue 24, eff. September 2, 2021.

12VAC30-20-570 Reconsideration of final agency decision

A. Reconsiderations of a DMAS final appeal decision issued on a formal appeal conducted pursuant to § 2.2-4020 of the Code of Virginia shall be conducted in accordance with § 2.2-4023.1 of the Code of Virginia.

B. The DMAS director's review shall be made upon the case record of the formal appeal. Testimony or documentary submissions that were not part of the formal appeal case record prior to issuance of the final agency decision shall not be considered.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 34, Issue 6, eff. December 13, 2017.

Chapter 40 Eligibility Conditions and Requirements

Part I General Conditions of Eligibility

12VAC30-40-10 General conditions of eligibility

Each individual covered under the plan:

1. Is financially eligible (using the methods and standards described in Parts II (12VAC30-40-20 through 12VAC30-40-80) and III (12VAC30-40-90 through 12VAC30-40-210) of this chapter) to receive services.

2. Meets the applicable nonfinancial eligibility conditions.

a. For the categorically needy:

(1) Except as specified under subdivisions 2 a (2) and 2 a (3) of this section, for Title IV-E individuals covered under § 1902(a)(10)(A)(i)(1), meet the nonfinancial eligibility conditions of the Medicaid program.

(2) For SSI-related individuals, meet the nonfinancial criteria of the SSI program or more restrictive SSI-related categorically needy criteria.

(3) For financially eligible parent/caretaker relatives, pregnant women, infants, or children covered under § 1902(a)(10)(A)(i)(IV), 1902(a)(10)(A)(i)(VI), 1902(a)(10)(A)(i)(VII), 1902(a)(10)(A)(ii)(IX), and 1931 of the Social Security Act (Act), meet the nonfinancial criteria of § 1902(l) of the Act.

(4) For financially eligible aged and disabled individuals covered under § 1902(a)(10)(A)(ii)(X) of the Act, meet the nonfinancial criteria of § 1902(m) of the Act.

b. For the medically needy, meet the nonfinancial eligibility conditions of 42 CFR Part 435.

c. For financially eligible qualified Medicare beneficiaries covered under § 1902(a)(10)(E)(i) of the Act, meet the nonfinancial criteria of § 1905(p) of the Act.

d. For financially eligible qualified disabled and working individuals covered under § 1902(a)(10)(E)(ii) of the Act, meet the nonfinancial criteria of § 1905(s).

3. May receive Medicaid eligibility if otherwise eligible. The Commonwealth provides Medicaid to citizens and nationals of the United States and certain noncitizens consistent with requirements of 42 CFR 435.406, including during a reasonable opportunity period pending verification of their citizenship, national status, or satisfactory immigration status. The Commonwealth provides Medicaid eligibility to otherwise eligible individuals:

a. Who are citizens or nationals of the United States;

b. Who are qualified noncitizens as defined in § 431 of the Personal Responsibility and Work Opportunity Reconciliation Act (PRWORA) (8 USC § 1641) or whose eligibility is required by § 402(b) of PRWORA (8 USC § 1612(b)) and certain qualified noncitizens whose eligibility is not prohibited by § 403 of PRWORA (8 USC § 1613); and

(1) (Reserved.)

(2) The Commonwealth limits eligibility to seven years for certain noncitizens, including those admitted to the United States as a:

(a) Refugee under § 207 of the Immigration and Nationality Act (INA) (8 USC § 1101 et seq.);

(b) Aslyee under § 208 of the INA;

(c) Deportee whose deportation is withheld under § 243(h) or 241(b)(3) of the INA;

(d) Cuban-Haitian entrant, as defined in § 501(e) of the Refugee Education Assistance Act of 1980;

(e) Amerasian; or

(f) Victim of a severe form of trafficking.

c. Who have declared themselves to be citizens or nationals of the United States, or any individual having satisfactory immigration status, during a reasonable opportunity period pending verification of their citizenship, nationality, or satisfactory immigration status consistent with requirements of §§ 1903(x), 1137(d), and 1902(ee) of the Act and 42 CFR 435.406, and 956;

d. Who is a noncitizen, who is not a qualified noncitizen, or who is a qualified noncitizen who arrived in the United States on or after August 22, 1996, whose coverage is not mandated by P.L. 104-193 (coverage must be restricted to certain emergency services); or

e. Who is a noncitizen who is a pregnant woman or who is a child younger than the age of 19 years who is legally residing in the United States and whose coverage is authorized under the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA). CHIPRA provides for coverage of the following individuals:

(1) A qualified noncitizen as defined in § 431 of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996;

(2) A noncitizen in nonimmigrant status who has not violated the terms of the status under which he was admitted or to which he has changed after admission;

(3) A noncitizen who has been paroled into the United States pursuant to § 212(d)(5) of the Immigration and Nationality Act (INA) for less than one year, except for a noncitizen paroled for prosecution, for deferred inspection, or pending removal proceedings;

(4) A noncitizen who belongs to one of the following classes:

(a) Individuals currently in temporary resident status pursuant to § 210 or 245A of the INA;

(b) Individuals currently under Temporary Protected Status (TPS) pursuant to § 244 of the INA and pending applicants to TPS who have been granted employment authorization;

(c) Noncitizens who have been granted employment authorization under 8 USC § 274a.12(c)(9), (10), (16), (18), (20), (22), or (24);

(d) Family unity beneficiaries pursuant to § 301 of P.L. No. 101-649 as amended;

(e) Noncitizens currently under Deferred Enforced Departure (DED) pursuant to a decision made by the President of the United States;

(f) Noncitizens currently in deferred action status; and

(g) Noncitizens whose visa petitions have been approved and who have a pending application for adjustment of status;

(5) Noncitizens who are pending applicants for asylum under § 208(a) of the INA or for withholding of removal under § 241(b)(3) of the INA or under the Convention against Torture who has been granted employment authorization, and such an applicant younger than the age of 14 years who has had an application pending for at least 180 days;

(6) A noncitizen who has been granted withholding of removal under the Convention against Torture;

(7) A child who has a pending application for Special Immigrant Juvenile status as described in § 101(a)(27)(J) of the INA;

(8) A noncitizen who is lawfully present in the Commonwealth of the Northern Mariana Islands under 48 USC § 1806(e); or

(9) A noncitizen who is lawfully present in American Samoa under the immigration laws of American Samoa.

4. Is a resident of the Commonwealth, regardless of whether or not the individual maintains the residence permanently or maintains a fixed address. The state has open interstate residency agreements.

5. Is not an inmate of a public institution. Public institutions do not include medical institutions, nursing facilities and intermediate care facilities for the intellectually disabled, publicly operated community residences that serve no more than 16 residents, or certain child care institutions.

6. a. Is required, as a condition of eligibility, to assign rights to medical support and to payments for medical care from any third party, to cooperate in obtaining such support and payments, and to cooperate in identifying and providing information to assist in pursuing any liable third party. The assignment of rights obtained from an applicant or recipient is effective only for services that are reimbursed by Medicaid. The requirements of 42 CFR 433.146 through 433.148 are met.

b. Shall also cooperate in establishing the paternity of any eligible child and in obtaining medical support and payments for himself and any other person who is eligible for Medicaid and on whose behalf the individual can make an assignment; except that individuals described in § 1902(l)(1)(A) of the Social Security Act (pregnant women and women in the postpartum period) are exempt from these requirements involving paternity and obtaining support. Any individual may be exempt from the cooperation requirements by demonstrating good cause for refusing to cooperate.

c. Shall also cooperate in identifying any third party who may be liable to pay for care that is covered under the state plan and providing information to assist in pursuing these third parties. Any individual may be exempt from the cooperation requirements by demonstrating good cause for refusing to cooperate.

7. a. Is required, as a condition of eligibility, to furnish his social security account number (or numbers, if he has more than one number) except for noncitizens seeking medical assistance for the treatment of an emergency medical condition under § 1903(v)(2) of the Social Security Act (§ 1137(f)).

b. Is required, under § 1903(x) to furnish satisfactory documentary evidence of both identity and of U.S. citizenship upon signing the declaration of citizenship required by § 1137(d) unless citizenship and identity has been verified by the Commissioner of Social Security pursuant to § 211 of the Children's Health Insurance Program Reauthorization Act (CHIPRA), or the individual is otherwise exempt from this requirement. Qualified noncitizens signing the declaration of satisfactory immigration status must also present and have verified documents establishing the claimed immigration status. Exception: Nonqualified noncitizens seeking medical assistance for the treatment of an emergency medical condition under § 1903(v)(2).

8. Is not required to apply for public assistance cash benefits under Title IV-A as a condition of applying for, or receiving Medicaid if the individual is a pregnant women, infant, or child that the state elects to cover under § 1902(a)(10)(A)(i)(IV) and 1902(a)(10)(A)(ii)(IX) of the Act.

9. Is required to apply for coverage under Medicare A, B or D, or any combination of Medicaid A, B, and D, if it is likely that the individual would meet the eligibility criteria for any or all of those programs. The state agrees to pay any applicable premiums and cost-sharing (except those applicable under Part D) for individuals required to apply for Medicare. Application for Medicare is a condition of eligibility unless the state does not pay the Medicare premiums, deductibles or co-insurance (except those applicable under Part D) for persons covered by the Medicaid eligibility group under which the individual is applying.

10. Is required, as a condition of eligibility for Medicaid payment of long-term care services, to disclose at the time of application for or renewal of Medicaid eligibility, a description of any interest the individual or his spouse has in an annuity (or similar financial instrument as may be specified by the Secretary of Health and Human Services). By virtue of the provision of medical assistance, the state shall become a remainder beneficiary for all annuities purchased on or after February 8, 2006.

11. Is ineligible for Medicaid payment of nursing facility or other long-term care services if the individual's equity interest in his home exceeds $500,000. This dollar amount shall be increased beginning with 2011 from year to year based on the percentage increase in the Consumer Price Index for all Urban Consumers rounded to the nearest $1,000.

This provision shall not apply if the individual's spouse, or the individual's child who is under age 21 years or who is disabled, as defined in § 1614 of the Social Security Act, is lawfully residing in the individual's home.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-02-2.6100 A, eff. June 16, 1993; amended, Virginia Register Volume 13, Issue 18, eff. July 1, 1997; Volume 22, Issue 23, eff. August 23, 2006; Volume 23, Issue 11, eff. March 7, 2007; Errata, 25:19 VA.R. 3464 May 25, 2009; amended, Virginia Register Volume 25, Issue 20, eff. July 23, 2009; Volume 27, Issue 9, eff. February 17, 2011; Errata, 27:10 VA.R. 964 January 17, 2011; amended, Virginia Register Volume 29, Issue 21, eff. July 17, 2013; Volume 33, Issue 21, eff. July 27, 2017; subdivision 3 b (1) withdrawn, Volume 33, Issue 23, eff. July 27, 2017; Errata, 33:24 VA.R. 2741 July 24, 2017.

Part II Post-Eligibility Treatment of Institutionalized Individuals

12VAC30-40-20 Post-eligibility treatment of institutionalized individuals

The following amounts are deducted from gross income when computing the application of an individual's or couple's income to the cost of institutional care:

1. Personal needs allowance.

a. Aged, blind, disabled:

Individuals: $40 PLUS *

Couples: $60 PLUS *

For the following individuals with greater need -- * (1) Patients in institutions who participate in work programs as part of treatment. The first $75.00 of earnings plus 1/2 the remainder, up to a maximum of $190.00 monthly is allowed to be retained for personal needs. * (2) Patients receiving institutional or home- and community-based waiver services who pay guardianship fees, the actual cost of guardian fees up to a maximum of 5% of gross income.

b. AFDC related:

Children: $40

Adults: $60

c. Individuals under age 21 covered in this plan as specified in Item b.7 of 12VAC30-30-20: $40

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-02-2.6100 B, eff. June 1, 1994; amended, Virginia Register Volume 23, Issue 18, eff. July 1, 2007.

12VAC30-40-30 Maintenance needs of non-institutionalized spouse

For maintenance of the non-institutionalized spouse only. The amount must be based on a reasonable assessment of need but must not exceed the highest of--

| | SSI level | $_________ | | --- | --- | --- | | | SSP level | $_________ | | | Monthly medically needy level | $_________ | | | Other as follows | $_________ |

See 12VAC30-40-80.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-2.6100 B, eff. June 1, 1994.

12VAC30-40-40 Children

For children, each family member. (Applies only to children not living with the community spouse.)

| | AFDC level | $__________ | | --- | --- | --- | | | Medically needy level | $ See below* | | | Other as follows | $__________ |

For children living with the community spouse, see 12VAC30-40-80.

• Group I: $216.67; Group II: $250; Group III: $325. For appropriate family size see 12VAC30-40-220.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-2.6100 B, eff. June 16, 1993.

12VAC30-40-50 Medical expenses

Amounts for incurred medical expenses not subject to payment by a third party

a. Health insurance premiums, deductibles and co-insurance charges

b. Necessary medical or remedial care not covered under the Medicaid plan

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-2.6100 B, eff. June 16, 1993.

12VAC30-40-60 Maintenance of residence

An amount for maintenance of a single individual's home for not longer than 6 months, if a physician has certified he or she is likely to return home within that period.

Amount for maintenance of home:

$ See below*

• Group I: $216.67; Group II: $250; Group III: $325. For appropriate family size see 12VAC30-40-220.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-2.6100 B, eff. June 16, 1993.

12VAC30-40-70 SSI benefits

SSI benefits paid under § 1611(e)(1)(E) of the Act to individuals who receive care in a hospital or NF.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-2.6100 B, eff. June 16, 1993.

12VAC30-40-80 Maintenance standards

Maintenance standard for community spouse and other dependent family members under § 1924 of the Act.

1. Community spouses: Standard based on formula contained in § 1924(d) is used.

2. Other family members who are dependent: Standard based on the formula contained in § 1924(d)(1)(c) is used.

3. The standards described above are used for individuals receiving home and community based services in lieu of services provided in medical or remedial institutions.

4. The definition of dependency below is used to define dependent children, parents and siblings for purposes of deducting allowances under § 1924.

a. Dependent children -- A child under age 21 and a child age 21 years old and older of either spouse who lives with a community spouse and who may be claimed as a dependent by either member of a couple for tax purposes under the Internal Revenue Services Code.

b. Dependent parents -- Parents of either member of a couple who reside with the community spouse and who may be claimed as dependents by either spouse for tax purposes under the Internal Revenue Services Code.

c. Dependent siblings -- A brother or sister of either member of a couple (including half-brothers and half-sisters and siblings gained through adoption) who reside with the community spouse and who may be claimed by either member of the married couple for tax purposes under the Internal Revenue Services Code.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-02-2.6100 B, eff. October 1, 1989; amended, Virginia Register Volume 17, Issue 13, eff. April 11, 2001.

Article 1 General

12VAC30-40-90 Income and resource levels and methods

Article 1 General

A. For individuals who are AFDC-related medically needy or SSI recipients, the income and resource levels and methods for determining countable income and resources of the AFDC and SSI program apply, unless the plan provides for more restrictive levels and methods than SSI for SSI recipients under § 1902(f) of the Act, or more liberal methods under § 1902(r)(2) of the Act, as specified in this section.

B. For individuals who are not AFDC-related medically needy or SSI recipients in a non-section 1902(f) state and those who are deemed to be cash assistance recipients, the financial eligibility requirements specified in this article apply.

C. 12VAC30-40-100 specifies the methods for determining income for individuals evaluated using modified adjusted gross income (MAGI) methodology.

D. 12VAC30-40-220 specifies the income levels for mandatory and optional categorically needy groups of individuals, including individuals with incomes related to the federal income poverty level, that is pregnant women and infants or children covered under §§ 1902(a)(10)(A)(i)(IV), 1902(a)(10)(A)(i)(VI), 1902(a)(10)(A)(i)(VII), and 1902(a)(10)(A)(ii)(IX) of the Act and aged and disabled individuals covered under § 1902(a)(10)(A)(ii)(X) of the Act, and for mandatory groups of qualified Medicare beneficiaries covered under § 1902(a)(10)(E)(i) of the Act.

E. 12VAC30-40-230 specifies the resource levels for mandatory and optional categorically needy poverty level related groups and for medically needy groups.

F. 12VAC30-40-260 specifies the income levels for categorically needy aged, blind, and disabled persons who are covered under requirements more restrictive than SSI.

G. 12VAC30-40-240 specifies the methods for determining resource eligibility used by states that have more restrictive methods than SSI, permitted under § 1902(f) of the Act.

H. 12VAC30-40-270 specifies the resource standards to be applied for categorically needy individuals in states that have elected to impose more restrictive eligibility requirements than SSI, permitted under § 1902(f) of the Act.

I. 12VAC30-40-280 specifies the methods for determining income eligibility used by states that are more liberal than the methods of the cash assistance programs, permitted under § 1902(r)(2) of the Act.

J. 12VAC30-40-290 specifies the methods for determining resource eligibility used by states that are more liberal than the methods of the cash assistance programs, permitted under § 1902(r)(2) of the Act.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-02-2.6100 C, eff. July 1, 1993; amended, VR460-02-2.6100:1, eff. November 15, 1995; Volume 33, Issue 21, eff. July 27, 2017.

Article 2 Income

12VAC30-40-100 Methods of determining income

A. Families and Children Medically Needy individuals.

1. In determining countable income for Families and Children Medically Needy individuals, the methods under the state's July 16, 1996, approved Aid to Families with Dependent Children plan and any more liberal methods described in 12VAC30-40-280 are used.

2. In determining relative financial responsibility, the agency considers only the income of spouses living in the same household as available to children living with parents until the children become 21 years of age.

3. Agency continues to treat women eligible under the provisions of § 1902(a)(10) of the Act as eligible, without regard to any changes in income of the family of which she is a member, for the 60-day period after her pregnancy ends and any remaining days in the month in which the 60th day falls.

B. Individuals subject to the use of modified adjusted gross income (MAGI) methodology. In determining income eligibility for individuals subject to the use of MAGI-based methodologies, the following shall apply:

1. The Commonwealth shall apply MAGI-based methodologies as described in this subsection, and consistent with 42 CFR 435.603 and § 1902(e)(14) of the Act. Individuals subject to the use of MAGI-based income methodologies include:

a. Parents/caretaker relatives under §§ 1902(a)(10)(A)(i)(l) and 1931 of the Act.

b. Pregnant women under §§ 1902(a)(10)(A)(i)(l), (lll), (IV), (ii)(l), ((IV), (IX) and 1931 of the Act.

c. Children under the age of 19 years under §§ 1902(a)(10)(A)(i)(l), (lll), (IV), (VI), (VII), (ii)((IV), (IX) and 1931 of the Act.

d. Reasonable classifications of children younger than the age of 21 years under §§ 1902(a)(10)(A)(ii)(l) and (IV) of the Act.

e. Individuals younger than the age of 21 years who are under a state adoption assistance agreement under § 1902(a)(10)(A)(ii)(VIII) of the Act.

2. In the case of determining the ongoing eligibility for individuals determined eligible for Medicaid on or before December 31, 2013, MAGI-based income methodologies shall not be applied until March 31, 2014, or the next regularly scheduled renewal of eligibility, whichever is later, if the applications of such methods should result in determination of ineligibility prior to such date.

C. In determining family size for the eligibility determination of a pregnant woman, the pregnant woman shall be counted as herself plus each of the children she is expected to deliver. In determining family size during the eligibility determination of the other individuals in a household that includes a pregnant woman, the pregnant woman shall be counted as just herself.

D. Financial eligibility shall be determined consistent with the following provisions:

1. Financial eligibility shall be based on current monthly income and family size when determining eligibility for new applicants.

2. Financial eligibility shall be based on current monthly household income and family size when determining eligibility for currently enrolled individuals.

3. Household income shall be the sum of the MAGI-based income of every individual included in the individual's household except as provided at 42 CFR 435.603(d)(2) through 42 CFR 435.603(d)(4).

4. An amount equivalent to five percentage points of the federal poverty level for the applicable family size shall be deducted, in determining eligibility for Medicaid, from the household income in accordance with 42 CFR 435.603(d).

5. The age used for children with respect to 42 CFR 435.603(f)(3)(iv) shall be 19 years of age.

E. Aged individuals. In determining countable income for aged individuals, including aged individuals with incomes up to the federal poverty level described in § 1902(m)(1) of the Act, the following methods are used.

1. The methods of the SSI program, any more liberal methods described in 12VAC30-40-280, or both apply.

2. For optional state supplement recipients in § 1902(f) states and SSI criteria states without § 1616 or § 1634 agreements, SSI methods, any more liberal methods than SSI described in 12VAC30-40-280, or both apply.

3. In determining relative financial responsibility, the agency considers only the income of spouses living in the same household as available to spouses.

F. Blind individuals. In determining countable income for blind individuals, only the methods of the SSI program, any more liberal methods described in 12VAC30-40-280, or both apply.

For optional state supplement recipients in § 1902(f) states and SSI criteria states without § 1616 or § 1634 agreements, the SSI methods, any more liberal methods than SSI described in 12VAC30-40-280, or both apply.

In determining relative financial responsibility, the agency considers only the income of spouses living in the same household as available to spouses and the income of parents as available to children living with parents until the children become 21 years of age.

G. Disabled individuals. In determining countable income of disabled individuals, including disabled individuals with incomes up to the federal poverty level described in § 1902(m) of the Act, the methods of the SSI program, any more liberal methods described in 12VAC30-40-280, or both apply.

For optional state supplement recipients in § 1902(f) of the Act states and SSI criteria states without § 1616 or § 1634 agreements, the SSI methods, any more liberal methods than SSI described in 12VAC30-40-280, or both apply.

In determining relative financial responsibility, the agency considers only the income of spouses living in the same household as available to spouses and the income of parents as available to children living with parents until the children become 21 years of age.

H. Qualified Medicare beneficiaries. In determining countable income for qualified Medicare beneficiaries covered under § 1902(a)(10)(E)(i) of the Act, the methods of the SSI program, more liberal methods described in 12VAC30-40-280, or both are used.

If an individual receives a Title II benefit, any amounts attributable to the most recent increase in the monthly insurance benefit as a result of a Title II COLA is not counted as income during a "transition period" beginning with January, when the Title II benefit for December is received, and ending with the last day of the month following the month of publication of the revised annual federal poverty level.

For individuals with Title II income, the revised poverty levels are not effective until the first day of the month following the end of the transition period.

For individuals not receiving Title II income, the revised poverty levels are effective no later than the date of publication.

I. Qualified disabled and working individuals. In determining countable income for qualified disabled and working individuals covered under § 1902(a)(10)(E)(ii) of the Act, the methods of the SSI program are used.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-02-2.6100 C, eff. June 16, 1993; amended, Virginia Register Volume 17, Issue 13, eff. April 11, 2001; Volume 20, Issue 4, eff. December 3, 2003; Volume 33, Issue 21, eff. July 27, 2017.

12VAC30-40-105 Financial eligibility

Working Individuals with Disabilities; Basic Coverage Group (Ticket to Work and Work Incentive Improvement Act (TWWIIA)).

The following standards and methods shall be applied in determining financial eligibility:

1. The agency applies the following income and resource standards to applicants of this program:

a. The individual's total countable income shall not exceed 80% of the current federal poverty income guidelines; and

b. The individual's total countable assets shall not exceed $2,000.

2. Income methodologies. In determining whether an individual meets the income standard described in subdivision 1 of this section, the agency uses more liberal income methodologies than the SSI program as further described in 12VAC30-40-280.

3. Resource methodologies. The agency uses resource methodologies in addition to any indicated in subdivisions 1 and 2 of this section that are more liberal than those used by the SSI program as described in 12VAC30-40-290.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. July 23, 2009.

12VAC30-40-110 Medicaid qualifying trusts

In the case of a Medicaid qualifying trust described in § 1902(k)(2) of the Act, the amount from the trust that is deemed available to the individual who established the trust (or whose spouse established the trust) is the maximum amount that the trustee is permitted under the trust to distribute to the individual. This amount is deemed available to the individual, whether or not the distribution is actually made. This provision does not apply to any trust or initial trust decree established before April 7, 1986, solely for the benefit of an individual with an intellectual disability who resides in an intermediate care facility for individuals with intellectual disabilities.

The policy for qualifying trusts that is effective for trusts established or assets disposed of after August 10, 1993, is located in 12VAC30-40-300.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-2.6100 C, eff. April 20, 1994; amended, Virginia Register Volume 42, Issue 11, eff. February 11, 2026.

12VAC30-40-120 Medically needy income levels (MNILs) based on family size

Medically needy income levels (MNILs) are based on family size.

12VAC30-40-220 specifies the MNILs for all covered medically needy groups. If the agency chooses more restrictive levels under § 1902(f) of the Act, 12VAC30-40-220 so indicates.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-2.6100 C, eff. April 20, 1994.

12VAC30-40-130 Handling of excess income; spend-down

Handling of excess income - Spend-down for the medically needy in all states and the categorically needy in 1902(f) states only.

a. Medically Needy

(1) Income in excess of MNIL is considered as available for payment of medical care and services. The Medicaid agency measures available income for periods of either 1 or 6 month(s) (not to exceed 6 months) to determine the amount of excess countable income applicable to the cost of medical care and services.

(2) If countable income exceeds the MNIL standard, the agency deducts the following incurred expenses in the following order:

(a) Health insurance premiums, deductibles, and coinsurance charges.

(b) Expenses for necessary medical and remedial care not included in the plan.

(c) Expenses for necessary medical and remedial care included in the plan.

Incurred expenses that are subject to payment by a third party are not deducted unless the expenses are subject to payment by a third party that is a publicly funded program (other than Medicaid) of a State or local government.

b. Categorically Needy - § 1902(f) states:

The agency applies the following policy under the provisions of § 1902(f) of the Act. The following amounts are deducted from income to determine the individual's countable income:

(1) Any SSI benefit received.

(2) Any State supplement received that is within the scope of an agreement described in § 1616 or 1634 of the Act, or a State supplement within the scope of § 1902(a)(10)(A)(ii)(XI) of the Act.

(3) Increases in OASDI that are deducted under §§ 435.134 and 435.135 for individuals specified in that section, in the manner elected by the State under than section.

(4) Incurred expenses for necessary medical and remedial services recognized under State law.

Incurred expenses that are subject to payment by a third party are not deducted unless the expenses are subject to payment by a third party that is a publicly funded program (other than Medicaid) of a State or local government.

NOTE: FFP will be reduced to the extent a State is paid a spenddown payment by the individual.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-2.6100 C, eff. June 16, 1993.

Article 3 Resources

12VAC30-40-140 Methods for determining resources

a. AFDC-related individuals (except for poverty level related pregnant women, infants, and children).

(1) In determining countable resources for AFDC-related individuals, the following methods are used:

(a) The methods under the state's approved AFDC plan; and/or

(b) Any more liberal methods described in 12VAC30-40-290.

(2) In determining relative financial responsibility, the agency considers only the resources of spouses living in the same household as available to spouses and the resources of parents as available to children living with parents until the children become 21.

b. Aged individuals. For aged individuals covered under § 1902(a)(10)(A)(ii)(X) of the Act, the agency used methods that are more restrictive (except for individuals described in § 1902(m)(1) of the Act) and/or more liberal than those of the SSI program for the treatment of resources. 12VAC30-40-240 describes the more restrictive methods and 12VAC30-40-290 specifies the more liberal methods.

In determining relative financial responsibility, the agency considers only the resources of spouses living in the same household as available to spouses.

c. Blind individuals. For blind individuals the agency uses methods that are more restrictive and/or more liberal than those of the SSI program for the treatment of resources. 12VAC30-40-240 describes the more restrictive methods and 12VAC30-40-290 specifies the more liberal methods.

In determining relative financial responsibility, the agency considers only the resources of spouses living in the same household as available to spouses and the resources of parents as available to children living with parents until the children become 21.

d. Disabled individuals, including individuals covered under § 1902(a)(10)(A)(ii)(X) of the Act. The agency used methods that are more restrictive (except for individuals described in § 1902(m)(1) of the Act) and/or more liberal than those of the SSI program for the treatment of resources. More restrictive methods are described in 12VAC30-40-240 and more liberal methods are specified in 12VAC30-40-290.

In determining relative financial responsibility, the agency considers only the resources of spouses living in the same household as available to spouses and the resources of parents as available to children living with parents until the children become 21.

e. Poverty level pregnant women covered under § 1902(a)(10)(A)(i)(IV) and § 1902(a)(10)(A)(ii)(IX)(A) of the Act.

The agency does not consider resources in determining eligibility.

In determining relative financial responsibility, the agency considers only the resources of spouses living in the same household as available to spouses and the resources of parents as available to children living with parents until the children become 21.

f. Poverty level infants covered under § 1902(a)(10)(A)(i)(IV) of the Act.

The agency does not consider resources in determining eligibility.

g. Poverty level children covered under § 1902(a)(10)(A)(i)(VI) of the Act.

(1) The agency does not consider resources in determining eligibility. In determining relative financial responsibility, the agency considers only the resources of spouses living in the same household as available to spouses and the resources of parents as available to children living with parents until the children become 21.

(2) Poverty level children under § 1902(a)(10)(A)(i)(VIII). The agency does not consider resources in determining eligibility.

In determining relative responsibility, the agency considers only the resources of spouses living in the same household as available to spouses and the resources of parents as available to children living with parents until the children become 21.

h. For Qualified Medicare beneficiaries covered under § 1902(a)(10)(E)(i) of the Act the agency uses methods that are more liberal than those of the SSI program for the treatment of resources. More liberal methods are specified in 12VAC30-40-290.

i. For qualified disabled and working individuals covered under § 1902(a)(10)(E)(ii) of the Act, the agency uses SSI program methods for the treatment of resources.

j. Reserved.

k. Specified low-income Medicare beneficiaries covered under § 1902(a)(10)(E)(iii) of the Act. The agency uses the same method as in subsection (h) of this section.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-02-2.6100 C, eff. June 16, 1993; amended, Virginia Register Volume 12, Issue 2, eff. November 15, 1995; Volume 20, Issue 4, eff. December 3, 2003.

12VAC30-40-150 Resource standard; categorically needy

A. Section 1902(f) states (except as specified under subsections C and D of this section) for aged, blind and disabled individuals: same as SSI resource standards. The resource standards for other individuals are the same as those in the related cash assistance program.

B. Non-1902(f) states (except as specified under subsections C and D of this section).

1. The resource standards are the same as those in the related cash assistance program.

2. 12VAC30-40-270 specifies for 1902(f) states the categorically needy resource levels for all covered categorically needy groups.

C. The agency does not apply a resource standard for pregnant women or infants covered under the provisions of §§ 1902(a)(10)(A)(i)(IV) and 1902(a)(10)(A)(ii)(IX) of the Act.

D. The agency does not apply a resource standard for parent/caretaker relatives or children covered under the provisions of § 1902(a)(10)(A)(i)(VI), 1902(a)(10)(A)(i)(l), or 1931 of the Act.

E. For aged and disabled individuals described in § 1902(m)(1) of the Act who are covered under § 1902(a)(10)(A)(ii)(X) of the Act, 12VAC30-40-230 specifies the resource levels for these individuals.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-02-2.6100 C, eff. June 16, 1993; amended, Virginia Register Volume 33, Issue 21, eff. July 27, 2017.

12VAC30-40-160 Resource standard; medically needy

a. Resource standards are based on family size.

b. A single standard is employed in determining resource eligibility for all groups.

12VAC30-40-230 specifies the resource standards for all covered medically needy groups. If the agency chooses more restrictive levels under this subsection, 12VAC30-40-230 so indicates.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-2.6100 C, eff. June 16, 1993.

12VAC30-40-170 Resource standard; qualified Medicare beneficiaries and specified low-income Medicare beneficiaries

For qualified Medicare beneficiaries covered under § 1902(a)(10)(E)(i) of the Act, and specified low-income Medicare beneficiaries covered under § 1902(a)(10)(E)(iii) of the Act, the resource standard is twice the SSI standard or, effective January 1, 2010, the resource limit set for the Medicare Part D Low Income Subsidy Program.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-02-2.6100 C, eff. June 16, 1993; amended, Virginia Register Volume 12, Issue 2, eff. November 15, 1995; Volume 26, Issue 14, eff. April 14, 2010.

12VAC30-40-180 Qualified disabled and working individuals

For qualified disabled and working individuals covered under 1902(a)(10)(E)(ii) of the Act, the resource standard for an individual or a couple (in the case of an individual with a spouse) is twice the SSI standard.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-2.6100 C, eff. June 16, 1993.

12VAC30-40-190 Excess resources

a. Categorically Needy, Qualified Medicare Beneficiaries, Qualified Disabled and Working Individuals, and Specified Low-Income Medicare Beneficiaries. Any excess resources make the individual ineligible.

b. Medically Needy. Any excess resources make the individual ineligible.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-02-2.6100 C, eff. June 16, 1993; amended, Virginia Register Volume 12, Issue 2, eff. November 15, 1995.

Article 4 Effective Date and Transfer of Resources

12VAC30-40-200 Effective date of eligibility

a. Groups Other Than Qualified Medicare Beneficiaries.

(1) For the prospective period. Coverage is available for the full month if aged, blind, disabled or AFDC-related individuals are eligible at any time during the month.

(2) For the retroactive period. Coverage is available for three months before the date of application if aged, blind, disabled or AFDC-related individuals would have been eligible had they applied.

b. For qualified Medicare beneficiaries defined in § 1905(p)(1) of the Act, coverage is available beginning with the first day of the month after the month in which the individual is first determined to be a qualified Medicare beneficiary under § 1905(p)(1). The eligibility determination is valid for 12 months.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-2.6100 C, eff. June 16, 1993.

12VAC30-40-210 Transfer of resources - categorically and medically needy, qualified Medicare beneficiaries, and qualified disabled and working individuals

The agency complies with the provisions of § 1917 of the Act with respect to the transfer of resources.

Disposal of resources at less than fair market value affect eligibility for certain services as detailed in 12VAC30-40-300.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-2.6100:1, eff. June 16, 1993.

Part IV Eligibility Requirements

12VAC30-40-220 Income eligibility levels

A. 1. Groups I, II, and III income limits are set forth in this subdivision 1.

| | Group I | | | | --- | --- | --- | --- | | | Size of assistance unit | Monthly | Yearly | | | 1 | $239 | $2,868 | | | 2 | 364 | 4,368 | | | 3 | 464 | 5,568 | | | 4 | 563 | 6,756 | | | 5 | 663 | 7,956 | | | 6 | 748 | 8,976 | | | 7 | 844 | 10,128 | | | 8 | 945 | 11,340 | | | Each additional person | 98 | 1,176 |

| | Group II | | | | --- | --- | --- | --- | | | Size of assistance unit | Monthly | Yearly | | | 1 | $313 | $3,756 | | | 2 | 449 | 5,388 | | | 3 | 565 | 6,780 | | | 4 | 675 | 8,100 | | | 5 | 794 | 9,528 | | | 6 | 895 | 10,740 | | | 7 | 1,002 | 12,024 | | | 8 | 1,119 | 13,428 | | | Each additional person | 111 | 1,332 |

| | Group III | | | | --- | --- | --- | --- | | | Size of assistance unit | Monthly | Yearly | | | 1 | $472 | 5,664 | | | 2 | 633 | 7,596 | | | 3 | 774 | 9,288 | | | 4 | 909 | 10,908 | | | 5 | 1,074 | 12,888 | | | 6 | 1,195 | 14,340 | | | 7 | 1,330 | 15,960 | | | 8 | 1,471 | 17,652 | | | Each additional person | 135 | 1,620 |

2. Pregnant women and infants under § 1902(a)(10)(i)(IV) of the Act. Effective January 1, 2014, based on 143% of the official federal income poverty level.

3. Children under § 1902(a)(10)(i)(VI) of the Act (children who have attained age one year but have not attained age six years), the income eligibility level is 143% of the federal poverty level (as revised annually in the Federal Register) for the size family involved.

4. For children under § 1902(a)(10)(i)(VII) of the Act (children who were born after September 30, 1983, and have attained age six years but have not attained age years), the income eligibility level is 143% of the federal poverty level (as revised annually in the Federal Register) for the size family involved.

B. Treatment of cost of living adjustment (COLA) for groups with income related to federal poverty level.

1. If an individual receives a Title II benefit, any amount attributable to the most recent increase in the monthly insurance benefit as a result of a Title II COLA is not counted as income during a "transition period" beginning with January, when the Title II benefit for December is received, and ending with the last day of the month following the month of publication of the revised annual federal poverty level.

2. For individuals with Title II income, the revised poverty levels are not effective until the first day of the month following the end of the transition period.

3. For individuals not receiving Title II income, the revised poverty levels are effective no later than the beginning of the month following the date of publication.

C. Qualified Medicare beneficiaries with incomes related to federal poverty level. The levels for determining income eligibility for groups of qualified Medicare beneficiaries under the provisions of § 1905(p)(2)(A) of the Act are as follows:

Section 1902(f) states, which as of January 1, 1987, used income standards more restrictive than SSI, Virginia did not apply a more restrictive income standard as of January 1, 1987.

Based on the following percentage of the official federal income poverty level:

Effective January 1, 1989: 85%

Effective January 1, 1990: 90% (no more than 100)

Effective January 1, 1991: 100% (no more than 100)

Effective January 1, 1992: 100%

D. Aged and disabled individuals described in § 1902(m)(1) of the Act; Level for determining income eligibility for aged and disabled persons described in § 1902(m)(1) of the Act is 80% of the official federal income poverty level (as revised annually in the Federal Register) for the size family involved.

E. Income levels - for medically needy. (Increased annually the increase in the Consumer Price Index but no higher than the level permitted to claim federal financial participation.

1. The following income levels are applicable to all groups, urban and rural.

2. The agency has methods for excluding from its claim for federal financial participation payments made on behalf of individuals whose income exceeds these limits.

| | (1) | (2) | (3) | | | | --- | --- | --- | --- | --- | --- | | | Family Size | Net income level protected for maintenance for 12 months | Amount by which Column 2 exceeds limits specified in 42 CFR 435.1007¹ | | | | | | Group I | Group II | Group III | | | | 1 | $2,691.00 | $3,105.00 | $4,036.50 | $0 | | | 2 | $3,519.00 | $3,824.00 | $4,867.00 | $0 | | | 3 | $4,036.50 | $4,450.50 | $5,485.50 | $0 | | | 4 | $4,554.00 | $4,968.00 | $6,003.00 | $0 | | | 5 | $5,071.50 | $5,485.50 | $6,520.50 | $0 | | | 6 | $5,589.00 | $6,003.00 | $7,038.00 | $0 | | | 7 | $6,106.50 | $6,520.50 | $7,555.50 | $0 | | | 8 | $6,727.50 | $7,141.50 | $8,073.00 | $0 | | | 9 | $7,348.50 | $7,762.50 | $8,797.50 | $0 | | | 10 | $8,073.00 | $8,487.00 | $9,418.50 | $0 | | | For each additional person, add: | $695.52 | $695.52 | $695.52 | $0 |

¹As authorized in § 4718 of OBRA '90.

| GROUPING OF LOCALITIES | | | --- | --- | | GROUP I: Counties | | | Accomack | King and Queen | | Alleghany | King William | | Amelia | Lancaster | | Amherst | Lee | | Appomattox | Louisa | | Bath | Lunenburg | | Bedford | Madison | | Bland | Matthews | | Botetourt | Mecklenburg | | Brunswick | Middlesex | | Buchanan | Nelson | | Buckingham | New Kent | | Campbell | Northampton | | Caroline | Northumberland | | Carroll | Nottoway | | Charles City | Orange | | Charlotte | Page | | Clarke | Patrick | | Craig | Pittsylvania | | Culpeper | Powhatan | | Cumberland | Prince Edward | | Dickenson | Prince George | | Dinwiddie | Pulaski | | Essex | Rappahannock | | Fauquier | Richmond | | Floyd | Rockbridge | | Fluvanna | Russell | | Franklin | Scott | | Frederick | Shenandoah | | Giles | Smyth | | Gloucester | Southampton | | Goochland | Spotsylvania | | Grayson | Stafford | | Greene | Surry | | Greensville | Sussex | | Halifax | Tazewell | | Hanover | Washington | | Henry | Westmoreland | | Highland | Wise | | Isle of Wight | Wythe | | James City | York | | King George | | | GROUP I: Cities | | | Bristol | Franklin | | Buena Vista | Galax | | Danville | Norton | | Emporia | Suffolk | | GROUP II: Counties | | | Albemarle | Loudoun | | Augusta | Roanoke | | Chesterfield | Rockingham | | Henrico | Warren | | GROUP II: Cities | | | Chesapeake | Petersburg | | Covington | Portsmouth | | Harrisonburg | Radford | | Hopewell | Richmond | | Lexington | Roanoke | | Lynchburg | Staunton | | Martinsville | Virginia Beach | | Newport News | Williamsburg | | Norfolk | Winchester | | GROUP III: Counties | | | Arlington | Montgomery | | Fairfax | Prince William | | GROUP III: Cities | | | Alexandria | Fredericksburg | | Charlottesville | Hampton | | Colonial Heights | Manassas | | Fairfax | Manassas Park | | Falls Church | Waynesboro |

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-03-2.6101:1, eff. June 30, 1994; amended, Virginia Register Volume 11, Issue 10, eff. March 9, 1995; Volume 11, Issue 24, eff. October 1, 1995; Volume 17, Issue 18, eff. July 1, 2001; Errata, 17:21 VA.R. 3124 July 2, 2001; amended, Virginia Register Volume 18, Issue 7, eff. January 16, 2002; Volume 18, Issue 18, eff. July 1, 2002; Volume 33, Issue 21, eff. July 27, 2017.

12VAC30-40-230 Resource levels

A. CATEGORICALLY NEEDY GROUPS WITH INCOMES RELATED TO FEDERAL POVERTY LEVEL

Resource levels are not applicable to pregnant women or children.

B. MEDICALLY NEEDY

Applicable to all groups -

| | Family Size | Resource Level | | --- | --- | --- | | | 1 | $2,000 | | | 2 | 3,000 | | | 3 | 3,100 | | | 4 | 3,200 | | | 5 | 3,300 | | | 6 | 3,400 | | | 7 | 3,500 | | | 8 | 3,600 | | | 9 | 3,700 | | | 10 | 3,800 | | | For each additional person | $100 |

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-03-2.6102, eff. June 16, 1993.

12VAC30-40-235 Reasonable limits on amounts for necessary medical or remedial care not covered under Medicaid

A. The Medicaid agency meets the requirements of 42 CFR 435.725, 42 CFR 435.832, and § 1924 of the Social Security Act, in that the agency will deduct amounts for incurred expenses for medical or remedial care that are not subject to payment by a third party, including medically necessary or remedial care recognized under state law but not covered under the state's Medicaid plan, subject to reasonable limits as specified in subsection B of this section.

B. All medical or remedial goods and services not subject to payment by a third party and not covered by Medicaid but recognized under state law must be prescribed by a physician, dentist, podiatrist or other practitioner with prescribing authority pursuant to Virginia law. The maximum amount that may be deducted from the patient's income for nursing facility residents shall be the maximum amount reimbursed by the higher of either Medicare or Medicaid for the same noncovered items or services.

C. If neither Medicaid nor Medicare has an allowed amount for the service rendered, then DMAS will protect from the individual's income:

1. For services, the amount of the provider's usual and customary charge; or

2. For supplies and durable medical equipment, the actual invoice cost plus the lesser of either:

a. The labor charges; or

b. A 30% mark-up from the invoice.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 20, Issue 19, eff. August 1, 2004.

12VAC30-40-240 More restrictive methods of treating resources than those of the SSI program: § 1902(f) states only

A. The following limitations apply to resources in addition to the resource requirements of the Supplemental Security Income (SSI) program for the aged, blind and disabled.

1. For income-producing property and other nonresidential property, appropriate equity and profit is to be determined by the pro rata share owned by an individual in relation to his proportionate share of the equity and profit.

2. Property in the form of an interest in an undivided estate is to be regarded as an asset when the value of the interest plus all other resources exceeds the applicable resource limit unless it is considered unsaleable for reasons other than being an undivided estate. An heir can initiate a court action to partition. If a partition suit is necessary (because at least one other owner of or heir to the property will not agree to sell the property) in order for the individual to liquidate the interest, estimated partition costs may be deducted from the property's value. However, if a partition would not result in the applicant or recipient securing title to property having value substantially in excess of the cost of the court action, the property would not be regarded as an asset.

B. Real property.

1. The current market value of real property is determined by ascertaining the tax assessed value of the property and applying to it the local assessment rate. For noncommercial real property only, the current market value may be determined through the use of a certified appraisal in lieu of the tax assessed value. The certified appraisal must be completed by an individual licensed by the Virginia Real Estate Appraiser Board and the cost of the certified appraisal shall be borne by the applicant or recipient or his designee. The equity value is the current market value less the amount due on any recorded liens against the property. "Recorded" means written evidence that can be substantiated, such as deeds of trust, liens, promissory notes, etc.

2. Real property contiguous to an individual's residence which does not meet the home property definitions in subdivision 3 of this subsection, the SSI income-producing requirement or the exceptions listed in subdivision 6 of this subsection and which is saleable according to the provisions in 12VAC30-40-290 C shall be counted as an available resource. The equity value of the contiguous property shall be added to the value of all other countable resources.

3. Ownership of a dwelling occupied by the applicant as his home does not affect eligibility. A home shall mean the house and lot used as the principal residence and all contiguous property as long as the value of the land, exclusive of the lot occupied by the house, does not exceed $5,000. In any case in which the definition of home as provided here is more restrictive than that provided in the State Plan for Medical Assistance in Virginia as it was in effect on January 1, 1972, then a home means the house and lot used as the principal residence and all contiguous property essential to the operation of the home regardless of value.

The lot occupied by the house shall be a measure of land as designated on a plat or survey or whatever the locality sets as a minimum size for a building lot, whichever is less. In localities where no minimum building lot requirement exists, a lot shall be a measure of land designated on a plat or survey or one acre, whichever is less.

Contiguous property essential to the operation of the home means:

a. Land used for the regular production of any food or goods for the household's consumption only, including:

(1) Vegetable gardens;

(2) Pasture land which supports livestock raised for milk or meat, and land used to raise chickens, pigs, etc. (the amount of land necessary to support such animals is established by the local extension service; however, in no case shall more land be allowed than that actually being used to support the livestock);

(3) Outbuildings used to process or store any of the above;

b. Driveways which connect the homesite to public roadways;

c. Land necessary to the home site to meet local zoning requirements (e.g. building sites, mobile home sites, road frontage, distance from road, etc.);

d. Land necessary for compliance with state or local health requirements (e.g., distance between home and septic tank, distance between septic tanks, etc.);

e. Water supply for the household;

f. Existing burial plots;

g. Outbuilding used in connection with the dwelling, such as garages or tool sheds.

All of the above facts must be fully reevaluated and documented in the case record before the home site determination is made.

4. An institutionalized individual's former residence is counted as an available resource if the recipient is institutionalized longer than six months after the date he was admitted. The former residence is disregarded if it is occupied by the recipient's:

a. Spouse;

b. Minor dependent child under age 18 years;

c. Dependent child under age 19 years if still in school or vocational training;

d. Adult child who is disabled according to the Medicaid or civil service disability definition, who was living in the home with the recipient for at least one year prior to the recipient's institutionalization, and who is dependent upon the recipient for his shelter needs; or

e. Parent who is age 65 years or older and who is disabled according to the Medicaid or civil service disability definition, who was living in the home with the recipient for at least one year prior to the recipient's institutionalization, and who is dependent upon the recipient for his shelter needs.

5. An applicant or recipient's proportional share of the value of property owned jointly with another person to whom the applicant or recipient is not married as tenants in common or joint tenants with the right of survivorship at common law is counted as a resource unless it is exempt property or is unsaleable.

6. Ownership of other real property generally precludes eligibility. Exceptions to this provision are: (i) when the equity value of the property, plus all other resources, does not exceed the appropriate resource limitation; (ii) the property is smaller than the county or city zoning ordinances allow for home sites or building purposes, or the property has less than the amount of road frontage required by the county or city for building purposes and adjoining land owners will not buy the property; or (iii) the property has no access, or the only access is through the exempted home site; or (iv) the property is contiguous to the recipient's home site and the survey expenses required for its sale reduce the value of such property, plus all other resources, below applicable resource limitations; or (v) the property cannot be sold after a reasonable effort to sell it has been made, as defined in 12VAC30-40-290.

C. Personal property.

1. Prepaid burial plans are counted as a resource since the money is refundable to the individual upon his request. Cemetery plots are not counted as resources. See 12VAC30-40-290.

2. Assets which can be liquidated such as cash, bank accounts, stocks, bonds, securities and deeds of trusts are considered resources.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-03-2.6105, eff. June 16, 1993; amended, Virginia Register Volume 17, Issue 13, eff. April 11, 2001; Volume 20, Issue 4, eff. December 3, 2003; Volume 32, Issue 26, eff. September 21, 2016.

12VAC30-40-250 Standards for optional state supplementary payments

| Payment Category (Reasonable Classification) | Administered by | Income Level | Income Disregards Employed | | | | --- | --- | --- | --- | --- | --- | | Gross | Net | | | | | | Federal | State | 1 person/Couple | 2 person/Couple | | | | | | | | | | | 1. Aged, blind, disabled in domiciliary facilities | X | 300% of Supplemental Security Income (SSI) payment limit | Maximum rates for homes are determined by the General Assembly and are published in the annual state Appropriations Act. | Disregards of SSI Program | | | 2. Aged, blind, disabled in approved adult foster care homes | X | 300% of SSI payment limit | Maximum rates for homes are determined by the General Assembly and are published in the annual state Appropriations Act. | Disregards of SSI Program | | | 3. Aged, blind, disabled in approved supportive housing | X | 300% of SSI payment limit | Maximum rates for homes are determined by the General Assembly and are published in the annual state Appropriations Act. | Disregards of SSI Program | | | | | | | | |

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-03-2.6106, eff. July 1, 1987; amended, Virginia Register Volume 17, Issue 13, eff. April 11, 2001; Volume 33, Issue 19, eff. June 29, 2017.

12VAC30-40-260 Income levels for 1902(f) states; categorically needy who are covered under requirements more restrictive than SSI

The SSI income levels for an individual or couple, as appropriate, are used. See 12VAC30-40-230.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-03-6107, eff. April 30, 1985; amended, Virginia Register Volume 12, Issue 2, eff. November 15, 1995.

12VAC30-40-270 Resource standards for 1902(f) states; categorically needy

The Commonwealth does not apply more restrictive resource standards. See 12VAC30-40-230.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-03-2.6108; eff April 30, 1985; amended, Virginia Register Volume 12, Issue 2, eff. November 15, 1995.

12VAC30-40-280 More liberal income disregards

A. For ADC-related medically needy cases, any individual or family applying for or receiving assistance shall be granted an income exemption consistent with the Social Security Act (Act) (§§ 1902(a)(10)(A)(ii)(VIII), (IX) and 1902(a)(10)(C)(ii)(I)). Any interest earned on one interest-bearing savings or investment account per assistance unit not to exceed $5,000, if the applicant, applicants, recipient or recipients designate that the account is reserved for purposes related to self-sufficiency, shall be exempt when determining eligibility for medical assistance for so long as the funds and interest remain on deposit in the account. For purposes of this section, "purposes related to self-sufficiency" shall include (i) paying for tuition, books, and incidental expenses at any elementary, secondary, or vocational school, or any college or university; (ii) for making down payment on a primary residence; or (iii) for establishment of a commercial operation that is owned by a member of the Medicaid assistance unit.

B. For aged, blind, and disabled individuals, both categorically and medically needy, with the exception of the special income level group of institutionalized individuals, the Commonwealth of Virginia shall disregard the value of in-kind support and maintenance when determining eligibility. In-kind support and maintenance means food, clothing, or shelter or any combination of these provided to an individual.

C. For all medically needy children covered under the family and children covered groups, (§§ 1902(a)(10)(A)(ii)(VIII), 1902(a)(10)(C)(ii)(I), and 1905(n) of the Act), the Commonwealth will disregard all earned income of a child under the age of 19 years who is a student.

D. For all medically needy individuals covered under the family and children covered groups (§§ 1902(a)(10)(A)(ii)(VIII), 1902(a)(10)(C)(ii)(I), and 1905(n) of the Act), the Commonwealth will disregard the fair market value of all in-kind support and maintenance as income in determining financial eligibility. In-kind support and maintenance means food, clothing or shelter or any combination of these provided to an individual.

E. Working individuals with disabilities eligible for assistance under § 1902(a)(10)(A)(ii)(XV) of the Act who wish to increase their earnings while maintaining eligibility for Medicaid must establish Work Incentive (WIN) accounts (see 12VAC30-40-290).

1. The Commonwealth shall disregard any increase in the amount of unearned income in Social Security Disability Insurance (SSDI) payment resulting from employment as a worker with disabilities eligible for assistance under § 1902(a)(10)(A)(ii)(XVI) of the Act, or as a result of a cost of living adjustment (COLA) to the SSDI payment if this additional amount of unearned income in SSDI payment from work or COLA, or both, is deposited into the individual's designated WIN account.

2. The Commonwealth shall disregard any amount of unearned income of an enrollee as a result of the receipt of unemployment insurance benefits due to loss of employment through no fault of his own if this unearned income from unemployment insurance payments is deposited into the individual's designated WIN account. This disregard shall only apply while an enrollee is in the six-month safety net, or "grace" period.

3. The Commonwealth shall disregard earned income up to $75,000 for workers with disabilities eligible for assistance under § 1902(a)(10)(A)(ii)(XV) of the Act. To be eligible for this earned income disregard, the income is subject to the following provisions:

a. Only earnings that are deposited into a Work Incentive (WIN) account can be disregarded for eligibility purposes.

b. All funds deposited and their source will be identified and registered with the department, for which prior approval has been obtained from the department, and for which the owner authorizes regular monitoring and reporting of these earnings and other information deemed necessary by the department for the proper administration of this provision.

c. Income from the individual's spouse, or if the individual is younger than 21 years of age, the individual's parents with whom he lives, will not be deemed to an applicant for MEDICAID WORKS or to an existing enrollee in MEDICAID WORKS when determining whether or not the individual meets the financial eligibility requirements for eligibility under this section.

F. For aged, blind and disabled individuals, both categorically and medically needy, with the exception of the special income level group of institutionalized individuals, the Commonwealth of Virginia shall disregard the value of income derived from temporary employment with the United States Census Bureau for a decennial census.

G. For all medically needy individuals covered under the family and children covered groups (§§ 1902(a)(10)(A)(i)(I), 1902(a)(10)(A)(i)(III), 1902(a)(10)(A)(i)(IV), 1902(a)(10)(A)(i)(V), 1902(a)(10)(A)(i)(VI), 1902(a)(10)(A)(i)(VII), 1902(a)(10)(A)(ii)(VIII), 1902(a)(10)(C)(ii)(I), and 1905(n) of the Act), the Commonwealth will disregard income derived from the temporary employment with the U.S. Census Bureau for a decennial census.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-03-2.6108.1, eff. March 9, 1995; amended, Virginia Register Volume 17, Issue 13, eff. April 11, 2001; Volume 18, Issue 18, eff. July 1, 2002; Volume 18, Issue 23, eff. September 1, 2002; Volume 20, Issue 4, eff. December 3, 2003; Volume 20, Issue 22, eff. September 25, 2004; Volume 25, Issue 11, eff. March 19, 2009; Volume 25, Issue 21, eff. July 23, 2009; Volume 30, Issue 5, eff. December 19, 2013; Volume 33, Issue 21, eff. July 27, 2017.

12VAC30-40-290 More liberal methods of treating resources under §1902(r)(2) of the Act: §1902(f) states

A. Resources to meet burial expenses. Resources set aside to meet the burial expenses of an applicant or recipient or that individual's spouse are excluded from countable assets. In determining eligibility for benefits for individuals, disregarded from countable resources is an amount not in excess of $3,500 for the individual and an amount not in excess of $3,500 for his spouse when such resources have been set aside to meet the burial expenses of the individual or his spouse. The amount disregarded shall be reduced by:

1. The face value of life insurance on the life of an individual owned by the individual or his spouse if the cash surrender value of such policies has been excluded from countable resources; and

2. The amount of any other revocable or irrevocable trust, contract, or other arrangement specifically designated for the purpose of meeting the individual's or his spouse's burial expenses.

B. Cemetery plots. Cemetery plots are not counted as resources regardless of the number owned.

C. Life rights. Life rights to real property are not counted as a resource. The purchase of a life right in another individual's home is subject to transfer of asset rules. See 12VAC30-40-300.

D. Reasonable effort to sell.

1. For purposes of this section, "current market value" is defined as the current tax assessed value. If the property is listed by a realtor, then the realtor may list it at an amount higher than the tax assessed value. In no event, however, shall the realtor's list price exceed 150% of the assessed value.

2. A reasonable effort to sell is considered to have been made:

a. As of the date the property becomes subject to a realtor's listing agreement if:

(1) It is listed at a price at current market value; and

(2) The listing realtor verifies that it is unlikely to sell within 90 days of listing given the particular circumstances involved (e.g., owner's fractional interest; zoning restrictions; poor topography; absence of road frontage or access; absence of improvements; clouds on title, right of way or easement; local market conditions);

b. When at least two realtors refuse to list the property. The reason for refusal must be that the property is unsaleable at current market value. Other reasons for refusal are not sufficient; or

c. When the applicant has personally advertised his property at or below current market value for 90 days by use of a "Sale By Owner" sign located on the property and by other reasonable efforts, such as newspaper advertisements, or reasonable inquiries with all adjoining landowners or other potential interested purchasers.

3. Notwithstanding the fact that the recipient made a reasonable effort to sell the property and failed to sell it, and although the recipient has become eligible, the recipient must make a continuing reasonable effort to sell by:

a. Repeatedly renewing any initial listing agreement until the property is sold. If the list price was initially higher than the tax-assessed value, the listed sales price must be reduced after 12 months to no more than 100% of the tax-assessed value.

b. In the case where at least two realtors have refused to list the property, the recipient must personally try to sell the property by efforts described in subdivision 2 c of this subsection for 12 months.

c. In the case of a recipient who has personally advertised his property for a year without success (the newspaper advertisements and "for sale" sign do not have to be continuous; these efforts must be done for at least 90 days within a 12-month period), the recipient must then:

(1) Subject his property to a realtor's listing agreement at price or below current market value; or

(2) Meet the requirements of subdivision 2 b of this subsection, which are that the recipient must try to list the property and at least two realtors refuse to list it because it is unsaleable at current market value; other reasons for refusal to list are not sufficient.

4. If the recipient has made a continuing effort to sell the property for 12 months, then the recipient may sell the property between 75% and 100% of its tax assessed value and such sale shall not result in disqualification under the transfer of property rules. If the recipient requests to sell his property at less than 75% of assessed value, he must submit documentation from the listing realtor, or knowledgeable source if the property is not listed with a realtor, that the requested sale price is the best price the recipient can expect to receive for the property at this time. Sale at such a documented price shall not result in disqualification under the transfer of property rules. The proceeds of the sale will be counted as a resource in determining continuing eligibility.

5. Once the applicant has demonstrated that his property is unsaleable by following the procedures in subdivision 2 of this subsection, the property is disregarded in determining eligibility starting the first day of the month in which the most recent application was filed, or up to three months prior to this month of application if retroactive coverage is requested and the applicant met all other eligibility requirements in the period. A recipient must continue his reasonable efforts to sell the property as required in subdivision 3 of this subsection.

E. Automobiles. Ownership of one motor vehicle does not affect eligibility. If more than one vehicle is owned, the individual's equity in the least valuable vehicle or vehicles must be counted. The value of the vehicles is the wholesale value listed in the National Automobile Dealers Official Used Car Guide (NADA) Book, Eastern Edition (update monthly). In the event the vehicle is not listed, the value assessed by the locality for tax purposes may be used. The value of the additional motor vehicles is to be counted in relation to the amount of assets that could be liquidated that may be retained.

F. Life, retirement, and other related types of insurance policies. Life, retirement, and other related types of insurance policies with face values totaling $1,500 or less on any one person 21 years old and older are not considered resources. When the face values of such policies of any one person exceed $1,500, the cash surrender value of the policies is counted as a resource.

G. Long-term care partnership insurance policy (partnership policy). Resources equal to the amount of benefits paid on the insured's behalf by the long-term care insurer through a Virginia issued long-term care partnership insurance policy shall be disregarded. A long-term care partnership insurance policy shall meet the following requirements:

1. The policy is a qualified long-term care partnership insurance policy as defined in § 7702B(b) of the Internal Revenue Code of 1986.

2. The policy meets the requirements of the National Association of Insurance Commissioners (NAIC) Long-Term Care Insurance Model Regulation and Long-Term Care Insurance Model Act as those requirements are set forth in § 1917(b)(5)(A) of the Social Security Act (42 USC § 1396p).

3. The policy was issued no earlier than May 1, 2007.

4. The insured individual was a resident of a partnership state when coverage first became effective under the policy. If the policy is later exchanged for a different long-term care policy, the individual was a resident of a partnership state when coverage under the earliest policy became effective.

5. The policy meets the inflation protection requirements set forth in § 1917(b)(1)(C)(iii)(IV) of the Social Security Act.

6. The Insurance Commissioner requires the issuer of the partnership policy to make regular reports to the federal Secretary of Health and Human Services that include notification of the date benefits provided under the policy were paid and the amount paid, the date the policy terminates, and such other information as the secretary determines may be appropriate to the administration of such partnerships. Such information shall also be made available to the Department of Medical Assistance Services upon request.

7. The state does not impose any requirement affecting the terms or benefits of a partnership policy that the state does not also impose on nonpartnership policies.

8. The policy meets all the requirements of the Bureau of Insurance of the State Corporation Commission described in 14VAC5-200.

H. (Reserved.)

I. Resource exemption for Aid to Dependent Children related medically needy (§ 1902(a)(10)(C) of the Act). For ADC-related medically needy cases, any individual or family applying for or receiving assistance may have or establish one interest-bearing savings or investment account per assistance unit not to exceed $5,000 if the applicant, applicants, recipient or recipients designate that the account is reserved for purposes related to self-sufficiency. Any funds deposited in the account shall be exempt when determining eligibility for medical assistance for so long as the funds and interest remain on deposit in the account. Any amounts withdrawn and used for purposes related to self-sufficiency shall be exempt. For purposes of this section, purposes related to self-sufficiency shall include, but are not limited to, (i) paying for tuition, books, and incidental expenses at any elementary, secondary, or vocational school, or any college or university; (ii) for making down payment on a primary residence; or (iii) for establishment of a commercial operation that is owned by a member of the medical assistance unit.

J. Disregard of resources. The Commonwealth of Virginia will disregard all resources for categorically needy children, pregnant women, and caretaker relatives covered under §§ 1902(a)(10)(A)(i)(I), 1902(a)(10)(A)(i)(III), 1902(a)(10)(A)(i)(IV), 1902(a)(10)(A)(i)(VI), 1902(a)(10)(A)(i)(VII), 1902(a)(10)(A)(ii)(IV), 1902(a)(10)(A)(ii)(VIII), 1931, and 1905(n) of the Social Security Act.

K. Household goods and personal effects. The Commonwealth of Virginia will disregard the value of household goods and personal effects. Household goods are items of personal property customarily found in the home and used in connection with the maintenance, use and occupancy of the premises as a home. Examples of household goods are furniture, appliances, televisions, carpets, cooking and eating utensils and dishes. Personal effects are items of personal property that are worn or carried by an individual or that have an intimate relation to the individual. Examples of personal property include clothing, jewelry, personal care items, prosthetic devices and educational or recreational items such as books, musical instruments, or hobby materials.

L. Determining eligibility based on resources. When determining Medicaid eligibility, an individual shall be eligible in a month if his countable resources were at or below the resource standard on any day of such month.

M. Working individuals with disabilities eligible for assistance under § 1902(a)(10)(A)(ii)(XV) of the Act who wish to increase their personal resources while maintaining eligibility for Medicaid shall establish Work Incentive (WIN) accounts. The Commonwealth will disregard up to the current annual SSI (Social Security Act, § 1619(b)) threshold amount (as established for Virginia by the Social Security Administration) held in WIN accounts for workers with disabilities eligible for assistance under § 1902(a)(10)(A)(ii)(XV) of the Act. To be eligible for this resource disregard, WIN accounts are subject to the following provisions:

1. Deposits to this account shall derive solely from the individual's income earned after electing to enroll in the Medicaid Buy-In (MBI) program.

2. The balance of this account shall not exceed the current annual SSI (Social Security Act § 1619(b)) threshold amount (as established for Virginia by the Social Security Administration).

3. This account will be held separate from nonexempt resources in accounts for which prior approval has been obtained from the department, and for which the owner authorizes regular monitoring and reporting including deposits, withdrawals, and other information deemed necessary by the department for the proper administration of this provision.

4. A spouse's resources will not be deemed to the applicant when determining whether or not the individual meets the financial eligibility requirements for eligibility under this section.

5. Resources accumulated in the Work Incentive account shall be disregarded in determining eligibility for aged, blind, and disabled Medicaid-covered groups for one year after the individual leaves the Medicaid Buy-In program.

6. In addition, excluded from the resource and asset limit include amounts deposited in the following types of IRS-approved accounts established as WIN accounts: retirement accounts, medical savings accounts, medical reimbursement accounts, education accounts and independence accounts. Assets retained in these WIN accounts shall be disregarded for all future Medicaid eligibility determinations for aged, blind, or disabled Medicaid-covered groups.

N. For all aged, blind, or disabled individuals, both categorically needy and medically needy, the Commonwealth shall disregard as resources amounts received as payment for involuntary sterilization under the Virginia Eugenical Sterilization Act, beyond the allowable nine-month exclusion by the SSI program's resource methodologies.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-03-2.6108.2, eff January 26, 1994; amended, Virginia Register Volume 11, Issue 10, eff March 9, 1995; Volume 15, Issue 18, eff. July 1, 1999; Volume 17, Issue 13, eff. April 11, 2001; Volume 18, Issue 18, eff. July 1, 2002; Volume 20, Issue 4, eff. December 3, 2003; Volume 20, Issue 22, eff. September 25, 2004; Volume 22, Issue 23, eff. August 23, 2006; Volume 23, Issue 14, eff. September 1, 2007; Volume 25, Issue 21, eff. July 23, 2009; Volume 33, Issue 19, eff. June 15, 2017; Volume 33, Issue 21, eff. July 27, 2017.

12VAC30-40-300 Transfer of resources

The agency provides for the denial of eligibility by reason of disposal of resources for less than fair market value. This section includes procedures applicable to all transfers of resources.

A. Except as noted below, the criteria for determining the period of ineligibility are the same as criteria specified in § 1613(c) of the Social Security Act (Act): Transfer of resources other than the home of an individual who is an inpatient in a medical institution.

1. The agency uses a procedure that provides for a total period of ineligibility greater than 24 months for individuals who have transferred resources for less than fair market value when the uncompensated value of disposed of resources exceeds $12,000. This period bears a reasonable relationship to the uncompensated value of the transfer. The computation of the period and the reasonable relationship of this period to the uncompensated value are described as follows:

This transfer of resources rule includes the transfer of the former residence of an inpatient in a medical institution.

2. The agency has provisions for waiver of denial of eligibility in any instance where the state determines that a denial would work an undue hardship.

B. Other than those procedures specified elsewhere in this section, the procedures for implementing denial of eligibility by reason of disposal of resources for less than fair market value are as follows:

1. If the uncompensated value of the transfer is $12,000 or less: the individual is ineligible for two years from the date of the transfer.

2. If the uncompensated value of the transfer is more than $12,000: the individual is ineligible two years, plus an additional two months for every $1,000 or part thereof of uncompensated value over $12,000, from the date of transfer.

C. Property transfer. An applicant for or recipient of Medicaid is ineligible for Medicaid if he transferred or otherwise disposed of his legal equitable interest in real or personal property for less than fair market value. Transfer of property precludes eligibility for two years from the date of the transfer if the uncompensated value of the property was $12,000 or less. If the uncompensated value was over $12,000 an additional two months of ineligibility will be added for each $1,000 of additional uncompensated value (see the table in subdivision 7 of this subsection). "Uncompensated value" means the current market value of the property, or equity in the property, at the time it was transferred, less the amount of compensation (money, goods, service, etc.) received for the property.

Exceptions to this provision are:

1. When the transfer was not made with the intent of establishing or retaining eligibility for Medicaid or SSI. Any transfer shall be presumed to have been for the purposes of establishing or retaining eligibility for Medicaid or SSI unless the applicant/recipient furnishes convincing evidence to establish that the transfer was exclusively for some other purpose.

a. The applicant/recipient has the burden of establishing, by objective evidence of facts rather than statement of subjective intent, that the transfer was exclusively for another purpose.

b. Such evidence shall include evidence that adequate resources were available at the time of the transfer for the applicant/recipient's support and medical care including nursing home care, considering his age, state of health, and life expectancy.

c. The declaration of another purpose shall not be sufficient to overcome this presumption of intent.

d. The establishment of the fact that the applicant/recipient did not have specific knowledge of Medicaid or SSI eligibility policy is not sufficient to overcome the presumption of intent.

2. Retention of the property would have no effect on eligibility unless the property is a residence of an individual in a nursing home for a temporary period.

3. When transfer of the property resulted in compensation (in money, goods, or services) to the applicant/recipient that approximated the equity value of the property.

4. When the receiver of the property has made payment on the cost of the applicant/recipient's medical care that approximates the equity value of the property.

5. When the property owner has been a victim of another person's actions, except those of a legal guardian, committee, or power-of-attorney, who obtained or disposed of the property without the applicant/recipient's full understanding of the action.

6. When prior to October 1, 1982, the Medicaid applicant transferred a prepaid burial account (plan) that was valued at less than $1,500 for the purpose of retaining eligibility for SSI and was found ineligible for Medicaid solely for that reason. The applicant, after reapplying, may be eligible regardless of the earlier transfer of a prepaid burial account if the applicant currently meets all other eligibility criteria.

7. When the property is transferred into an irrevocable trust designated solely for the burial of the transferor or his spouse. The amount transferred into the irrevocable burial trust, together with the face value of life insurance and any other irrevocable funeral arrangements, shall not exceed $2,000 prior to July 1, 1988, and shall not exceed $2,500 after July 1, 1988.

| | Period of Ineligibility Due to Transfer of Property Table | | | | --- | --- | --- | --- | | | Uncompensated | Value of Property | Period of Ineligibility | | | 0 | $12,000.00 | 24 months | | | $12,000.01 | $13,000.00 | 26 months | | | $13,000.01 | $14,000.00 | 28 months | | | $14,000.01 | $15,000.00 | 30 months | | | $15,000.01 | $16,000.00 | 32 months | | | For each additional $1,000.00, add two months of ineligibility. | | |

D. The preceding policy applies to eligibility determinations on and before June 30, 1988. The following policy applies to eligibility determinations on and after July 1, 1988.

1. The State plan provides for a period of ineligibility for nursing facility services, equivalent services in a medical institution, and home and community-based services in the case of an institutionalized individual (as defined in paragraph (3) of § 1917(c) who, disposed of resources for less than fair market value, at any time during or after the 30-month period immediately before the date the individual becomes an institutionalized individual (if the individual is entitled to medical assistance under the State Plan on that date) or, if the individual is not entitled on the date of institutionalization, the date the individual applies for assistance while an institutionalized individual.

a. Thirty months; or

b. The total uncompensated value of the resources so transferred, divided by the average cost, to a private patient at the time of application, of nursing facility services in the state.

2. An individual shall not be ineligible for medical assistance by reason of subdivision 1 of this subsection to the extent that:

a. The resources transferred were a home and title to the home was transferred to:

(1) The spouse of such individual;

(2) A child of such individual who is under age 21 years, or is blind or disabled as defined in § 1614 of the Social Security Act;

(3) A sibling of such individual who has an equity interest in such home and who was residing in such individual's home for a period of at least one year immediately before the date the individual becomes an institutionalized individual; or

(4) A son or daughter of such individual (other than a child described in subdivision 2 a (2) of this subsection) who was residing in such individual's home for a period of at least two years immediately before the date the individual becomes an institutionalized individual; and who (as determined by the state) provided care to such individual that permitted such individual to reside at home rather than in such an institution or facility.

b. The resources were transferred to (or to another for sole benefit of) the community spouse as defined in § 1924(h)(2) of the Social Security Act, or to the individual's child who is under age 21 years, or is blind or disabled as defined in § 1614 of the Social Security Act.

c. A satisfactory showing is made to the state (in accordance with any regulations promulgated by the Secretary of United States Department of Health and Human Services) that:

(1) The individual intended to dispose of the resources either at fair market value, or for other valuable consideration. To show intent to receive adequate compensation, the individual must provide objective evidence that:

(a) For real property, the individual made an initial and continuing effort to sell the property according to the "reasonable effort to sell" provisions of the Virginia Medicaid State Plan;

(b) For real or personal property, the individual made a legally binding contract that provided for receipt of adequate compensation in a specified form (goods, services, money, etc.) in exchange for the transferred property;

(c) An irrevocable burial trust of $2,500 or less was established on or after July 1, 1988, as compensation for the transferred money;

(d) An irrevocable burial trust over $2500 was established on or after July 1, 1988, and the individual provides objective evidence to show that all funds in the trust are for identifiable funeral services; or

(2) The resources were transferred exclusively for a purpose other than to qualify for medical assistance; the individual must provide objective evidence that the transfer was exclusively for another purpose and the reason for the transfer did not include possible or future Medicaid eligibility; or

(3) Consistent with § 1917(c)(2)(D), an institutionalized spouse who (or whose spouse) transferred resources for less than fair market value shall not be found ineligible for nursing facility service, for a level of care in a medical institution equivalent to that of nursing facility services, or for home and community-based services where the state determines that denial of eligibility would work an undue hardship under the provision of § 1917(c)(2)(D) of the Social Security Act.

3. In this section, the term "institutionalized individual" means an individual who is an inpatient in a nursing facility, or who is an inpatient in a medical institution and with respect to whom payment is made based on a level of care provided in a nursing facility, or who is described in § 1902 (a)(10)(A)(ii)(VI).

4. In this section, the individual's home is defined as the house and lot used as the principal residence and all contiguous property up to $5,000.

E. Transfers and trusts after August 10, 1993. The following policy applies to medical assistance provided for services furnished on or after October 1, 1993, with respect to assets disposed of after August 10, 1993, and before February 8, 2006. It also applies to trusts established after August 10, 1993.

1. Definitions.

"Assets" means, with respect to an individual, all income and resources of the individual and of the individual's spouse, including any income or resources that the individual or the individual's spouse is entitled to but does not receive because of action:

a. By the individual or the individual's spouse;

b. By a person, including a court or administrative body, with legal authority to act in place of or on behalf of the individual or the individual's spouse; or

c. By any person, including any court or administrative body, acting at the direction or upon the request of the individual or the individual's spouse.

"Income" has the meaning given such term in § 1612 of the Social Security Act.

"Institutionalized individual" means an individual who is an inpatient in a nursing facility, who is an inpatient in a medical institution and with respect to whom payment is made based on a level of care provided in a nursing faculty or who is described in § 1902(a)(10)(A)(ii)(VI) of the Social Security Act.

"Resources" has the meaning given such term in § 1613 of the Social Security Act, without regard (in the case of an institutionalized individual) to the exclusion described in subsection (a)(1) of such section.

2. Transfer of assets rule. An institutionalized individual who disposes of, or whose spouse disposes of, assets for less than fair market value on or after the look-back date specified in subdivision 2 b of this subsection shall be ineligible for nursing facility services, a level of care in any institution equivalent to that of nursing facility services and for home or community-based services furnished under a waiver granted under § 1915(c) of the Social Security Act.

a. Period of ineligibility. The ineligibility period shall begin on the first day of the first month during or after which assets have been transferred for less than fair market value and that does not occur in any other period of ineligibility under this section. The ineligibility period shall be equal to but shall not exceed the number of months derived by dividing:

(1) The total, cumulative uncompensated value of all assets transferred as defined in subdivision E 1 of this section on or after the look-back date specified in subdivision E 2 b of this section by

(2) The average monthly cost to a private patient of nursing facility services in the Commonwealth at the time of application for medical assistance.

b. Look-back date. The look-back date is a date that is 36 months (or 60 months in the case of payments from a trust or portions of a trust that are treated as assets disposed of by the individual pursuant to this section or subdivision 3 of this subsection) before the first date as of which the individual both is an institutionalized individual and has applied for medical assistance under the State Plan for Medical Assistance.

c. Exceptions. An individual shall not be ineligible for medical assistance by reason of this section to the extent that:

(1) The assets transferred were a home and title to the home was transferred to:

(a) The spouse of the individual;

(b) A child of the individual who is under age 21 years, or is blind or disabled as defined in § 1614 of the Social Security Act;

(c) A sibling of the individual who has an equity interest in the home and who was residing in the individual's home for a period of a least one year immediately before the date the individual becomes an institutionalized individual; or

(d) A son or daughter of the individual (other than a child described in subdivision 2 C (1) (b) of this subsection) who was residing in the individual's home for a period of at least two years immediately before the date the individual becomes an institutionalized individual, and who provided care to the individual that permitted the individual to reside at home rather than in an institution or facility.

(2) The assets:

(a) Were transferred to the individual's spouse or to another person for the sole benefit of the individual's spouse;

(b) Were transferred from the individual's spouse to another for the sole benefit of the individual's spouse;

(c) Were transferred to the individual's child who is under age 21 years or who is disabled as defined in § 1614 of the Social Security Act or to a trust (including a trust described in subdivision 3 g of this subsection) established solely for the benefit of such child; or

(d) Were transferred to a trust (including a trust described in subdivision 3 g of this subsection) established solely for the benefit of an individual under age 65 years who is disabled as defined in § 1614(a)(3) of the Social Security Act.

(3) A satisfactory showing is made that:

(a) The individual intended to dispose of the assets either at fair market value, or for other valuable consideration;

(b) The assets were transferred exclusively for a purpose other than to qualify for medical assistance;

(c) All assets transferred for less than fair market value have been returned to the individual; or

(d) The Commonwealth determines that the denial of eligibility would work an undue hardship.

d. Assets held in common with another person. In the case of an asset held by an individual in common with another person or persons in a joint tenancy, tenancy in common, or other arrangement recognized under state law, the asset (or the affected portion of such asset) shall be considered to be transferred by such individual when any action is taken, either by such individual or by any other person, that reduces or eliminates such individual's ownership or control of such asset.

e. Transfers by both spouses. In the case of a transfer by the spouse of an individual that results in a period of ineligibility for medical assistance, the Commonwealth shall apportion the period of ineligibility (or any portion of the period) among the individual and the individual's spouse if the spouse otherwise becomes eligible for medical assistance under the State Plan.

3. For trusts created after August 10, 1993. For purposes of determining an individual's eligibility for, or amount of, medical assistance benefits, subject to subdivision 3 g of this subsection, these rules shall apply.

a. Trust defined. The term "trust" includes any legal instrument or device that is similar to a trust but includes an annuity only to such extent and in such manner as the U.S. Secretary of Health and Human Services specifies for purposes of administration of § 1917(c) or (d) of the Social Security Act.

b. Creation of trust defined. For purposes of this subsection, an individual shall be considered to have established a trust if assets of the individual were used to form all or part of the corpus of the trust and if any of the following individuals established the trusts other than by will:

(1) The individual;

(2) The individual's spouse;

(3) A person, including a court or administrative body, with legal authority to act in place of or on behalf of the individual or the individual's spouse;

(4) A person, including any court or administrative body, acting at the direction or upon the request of the individual or the individual's spouse.

c. Proportional interest in a trust. In the case of a trust the corpus of which includes assets of an individual (as determined under subdivision 3 b of this subsection) and assets of any other person or persons, the provision of this section shall apply to the portion of the trust attributable to the assets of the individual.

d. Affected trust. Subject to subdivision 3 g of this subsection, this section shall apply without regard to:

(1) The purposes for which a trust is established;

(2) Whether the trustee has or exercises any discretion under the trust;

(3) Any restrictions on when or whether distributions may be made from the trust; or

(4) Any restrictions on the use of distributions from the trust.

e. Revocable trusts. In the case of a revocable trust,

(1) The corpus of the trust shall be considered resources available to the individual;

(2) Payments from the trust to or for the benefit of the individual shall be considered income of the individual; and

(3) Any other payments from the trust shall be considered assets disposed of by the individual for the purposes of subdivision E 2 of this section.

f. Irrevocable trust. In the case of an irrevocable trust,

(1) If there are any circumstances under which payment from the trust could be made to or for the benefit of the individual, the portion of the corpus from which, or the income on the corpus from which, payment to the individual could be made shall be considered resources available to the individual, and payments from that portion of the corpus or income:

(a) To or for the benefit of the individual, shall be considered income of the individual; and

(b) For any other purpose, shall be considered a transfer of assets by the individual subject to subdivision E 2 of this section; and

(2) Any portion of the trust from which, or any income on the corpus from which, no payment could under any circumstances be made to the individual shall be considered, as of the date of establishment of the trust (or, if later, the date on which payment to the individual was foreclosed) to be assets disposed by the individual for purposes of subdivision E 2 of this section, and the value of the trust shall be determined for purposes of such section by including the amount of any payments made from such portion of the trust after such date.

g. Exceptions. This section shall not apply to any of the following trusts:

(1) A trust containing the assets of an individual under age 65 years who is disabled (as defined in § 1614(a)(3) of the Social Security Act) and that is established for the benefit of such individual by a parent, grandparent, legal guardian of the individual or a court if the Commonwealth will receive all amounts remaining in the trust upon the death of the individual up to an amount equal to the total medical assistance paid on behalf of the individual under this State Plan.

(2) A trust containing the assets of an individual who is disabled (as defined in § 1614(a)(3) of the Social Security Act) that meets all of the following conditions:

(a) The trust is established and managed by a nonprofit association.

(b) A separate account is maintained for each beneficiary of the trust, but, for purposes of investment and management of funds, the trust pools these accounts.

(c) Accounts in the trust are established solely for the benefit of individuals who are disabled (as defined in § 1614(a)(3) of the Social Security Act) by the parent, grandparent, or legal guardian of such individuals, by such individuals, or by a court.

(d) To the extent that amounts remaining in the beneficiary's account upon the death of the beneficiary are not retained by the trust, the trust pays to the Commonwealth from such remaining amounts in the account an amount equal to the total amount of medical assistance paid on behalf of the beneficiary under this State Plan.

F. Transfers made on or after February 8, 2006. The following policy applies to medical assistance provided for services furnished on or after February 8, 2006, with respect to assets disposed of on or after February 8, 2006.

1. Definitions.

"Assets" means, with respect to an individual, all income and resources of the individual and of the individual's spouse, including any income or resources that the individual or the individual's spouse is entitled to but does not receive because of action:

a. By the individual or the individual's spouse;

b. By a person, including a court or administrative body, with legal authority to act in place of or on behalf of the individual or the individual's spouse; or

c. By any person, including any court or administrative body, acting at the direction or upon the request of the individual or the individual's spouse.

The term "assets" includes the purchase of a life estate interest in another individual's home unless the purchaser resides in the home for a period of at least one year after the date of the purchase. The term "assets" also includes funds used to purchase a promissory note, loan, or mortgage unless such note, loan, or mortgage:

a. Has a repayment term that is actuarially sound (determined in accordance with actuarial publications of the Social Security Administration);

b. Provides for payments to be made in equal amounts during the term of the loan with no deferral and no balloon payments made; and

c. Prohibits the cancellation of the balance upon the death of the lender.

In the case of a promissory note, loan, or mortgage that does not satisfy the requirements of subdivisions a through c of this definition, the value of such note, loan, or mortgage shall be the outstanding balance due as of the date of the individual's application for medical assistance.

"Income" has the meaning given such term in § 1612 of the Social Security Act.

"Institutionalized individual" means an individual who is an inpatient in a nursing facility, who is an inpatient in a medical institution and with respect to whom payment is made based on a level of care provided in a nursing facility, or who is described in § 1902(a)(10)(A)(ii)(VI) of the Social Security Act.

"Resources" has the meaning given such term in § 1613 of the Social Security Act, without regard (in the case of an institutionalized individual) to the exclusion described in subsection (a)(1) of such section.

2. Transfer of assets rule. An institutionalized individual who disposes of, or whose spouse disposes of, assets for less than fair market value on or after the look-back date specified in subdivision 2 b of this subsection shall be ineligible for nursing facility services, a level of care in any institution equivalent to that of nursing facility services, and for home or community-based services furnished under a waiver granted under of § 1915(c) of the Social Security Act.

a. Period of ineligibility. The ineligibility period shall begin on the first day of a month during or after which assets have been transferred for less than fair market value, or the date on which the individual is eligible for medical assistance under the State Plan and would otherwise be receiving Medicaid-covered institutional level care based on an approved application for such care but for the application of the penalty period, whichever is later, and that does not occur in any other period of ineligibility under this section. The ineligibility period shall be equal to but shall not exceed the number of months, including any fractional portion of a month, derived by dividing:

(1) The total, cumulative uncompensated value of all assets transferred as defined in subdivision 1 of this subsection on or after the look-back date specified in subdivision 2 b of this subsection by

(2) The average monthly cost to a private patient of nursing facility services in the Commonwealth at the time of application for medical assistance.

b. Look-back date. The look-back date is a date that is 60 months before the first date the individual is both an institutionalized individual and has applied for medical assistance under the State Plan for Medical Assistance.

c. Exceptions. An individual shall not be ineligible for medical assistance by reason of this section to the extent that:

(1) The assets transferred were a home and title to the home was transferred to:

(a) The spouse of the individual;

(b) A child of the individual who is under age 21 years, or is blind or disabled as defined in § 1614 of the Social Security Act;

(c) A sibling of the individual who has an equity interest in the home and who was residing in the individual's home for a period of a least one year immediately before the date the individual becomes an institutionalized individual; or

(d) A son or daughter of the individual (other than a child described in subdivision 2 b c (1) (b) of this subsection) who was residing in the individual's home for a period of at least two years immediately before the date the individual becomes an institutionalized individual, and who provided care to the individual that permitted the individual to reside at home rather than in an institution or facility.

(2) The assets:

(a) Were transferred to the individual's spouse or to another person for the sole benefit of the individual's spouse;

(b) Were transferred from the individual's spouse to another for the sole benefit of the individual's spouse;

(c) Were transferred to the individual's child who is under age 21 years or who is disabled as defined in § 1614 of the Social Security Act, or to a trust (including a trust described in subdivision E 3 g of this section) established solely for the benefit of such child; or

(d) Were transferred to a trust (including a trust described in subdivision E 3 g of this section) established solely for the benefit of an individual under age 65 years who is disabled as defined in § 1614(a)(3) of the Social Security Act.

(3) A satisfactory showing is made that:

(a) The individual intended to dispose of the assets either at fair market value, or for other valuable consideration;

(b) The assets were transferred exclusively for a purpose other than to qualify for medical assistance;

(c) All assets transferred for less than fair market value have been returned to the individual; or

(d) The Commonwealth determines that the denial of eligibility would work an undue hardship.

d. Assets held in common with another person. In the case of an asset held by an individual in common with another person or persons in a joint tenancy, tenancy in common, or other arrangement recognized under state law, the asset (or the affected portion of such asset) shall be considered to be transferred by such individual when any action is taken, either by such individual or by any other person, that reduces or eliminates such individual's ownership or control of such asset.

e. Transfers by both spouses. In the case of a transfer by the spouse of an individual that results in a period of ineligibility for medical assistance, the Commonwealth shall apportion the period of ineligibility (or any portion of the period) among the individual and the individual's spouse if the spouse otherwise becomes eligible for medical assistance under the State Plan.

3. Annuities: The following shall govern annuities:

a. For purposes of this section, the purchase of an annuity by the institutionalized spouse or the community spouse will be treated as the disposal of an asset for less than fair market value unless:

(1) The state is named as the remainder beneficiary in the first position for at least the total amount of medical assistance paid on behalf of the annuitant; or

(2) The state is named as a remainder beneficiary in the second position after the community spouse or minor or disabled child and is named in the first position if such spouse or a representative of such child disposes of any remainder for less than fair market value.

b. The purchase of annuity by or on behalf of an annuitant who has applied for medical assistance for long-term care services will be considered a transfer of assets for less than fair market value unless:

(1) The annuity is described in subsection (b), individual retirement annuities, or (q), deemed IRAs under qualified employer plans, of § 408 of the Internal Revenue Code of 1986; or

(2) Purchased with the proceeds from:

(a) An account or trust described in subsection (a), individual retirement account, (c), accounts established by employers and certain associations of employees, or (p), simple retirement accounts, of § 408 of such Code;

(b) A simplified employee pension (within the meaning of § 408(k) of such Code); or

(c) A Roth IRA described in § 408A of such Code; or

(3) The annuity is:

(a) Irrevocable and nonassignable;

(b) Is actuarially sound (as determined by Social Security Administration publications); and

(c) Provides for payments in equal amounts during the term of the annuity with no deferral and no balloon payments made.

c. For annuities purchased prior to February 8, 2006, certain transactions occurring on or after that date shall make an annuity subject to this section including any action taken by the individual that changes the course of payment made by the annuity or the treatment of the income or principal of the annuity. The Commonwealth shall take such changes into account in determining the amount of the state's obligation for medical assistance or in the individual's eligibility for such assistance.

(1) These actions include additions of principal, elective withdrawals, requests to change the distribution of the annuity, elections to annuitize the contract, and similar actions.

(2) Changes that occur based on the terms of the annuity that existed prior to February 8, 2006, and that do not require a decision, election, or action to take effect shall not be subject to this section.

(3) Changes beyond the control of the individual, such as a change in law, in the policies of the insurer, or in the terms based on other factors, shall not cause the annuity to be subject to this section.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-03-2.6109, eff. October 1, 1993; amended, Virginia Register Volume 22, Issue 23, eff. August 23, 2006; Volume 33, Issue 21, eff. July 27, 2017.

12VAC30-40-310 [Reserved]. (Reserved)

12VAC30-40-320 Consideration of Medicaid qualifying trust; undue hardship

A. The following criteria will be used to determine whether the agency will not count the funds in a trust as specified in 12VAC30-40-110, because it would work an undue hardship for categorically and medically needy individuals:

B. The Commonwealth does not, at the present time, recognize undue hardships in cases of qualifying trusts. In determining eligibility for Medicaid the maximum amount of payments permitted under the terms of a "Medicaid qualifying trust" to be distributed to the grantor, if the trustee exercised discretion to the fullest extent possible, shall be considered available in determining the grantor's eligibility for Medicaid.

A "Medicaid qualifying trust" is a trust, or similar legal device, established (other than by will) by an individual (or an individual's spouse) under which the individual may be beneficiary of all or part of the payments from the trust and the distribution of such payments is determined by one or more trustees who are permitted to exercise any discretion with respect to the distribution to the individual.

C. The requirements of this section shall apply without regard to:

1. Whether or not the Medicaid qualifying trust is irrevocable or is established for purposes other than to enable a grantor to qualify for Medicaid; or

2. Whether or not the trustee exercises discretion to distribute any payments to the individual.

D. This provision shall not apply to any trust or initial trust decree established prior to April 7, 1986, solely for the benefit of an individual with an intellectual disability who resides in an intermediate care facility for individuals with intellectual disabilities.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-03-2.6110, eff. June 16, 1993; amended, Virginia Register Volume 42, Issue 11, eff. February 11, 2026.

12VAC30-40-330 Cost effectiveness methodology for COBRA continuation beneficiaries

Cost effectiveness methodology for COBRA continuation beneficiaries is not applicable.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-03-2.6111, eff. November 15, 1995.

12VAC30-40-340 Compliance with § 1924 and OBRA 90

a. Income and Resource eligibility policies used to determine eligibility for institutionalized spouses who have spouses living in the community are consistent with § 1924.

b. In the determination of resource eligibility the state resource standard is $12,000 adjusted annually in accordance with § 1924(g).

c. An institutionalized spouse who (or whose spouse) has excess resources shall not be found ineligible under Title XIX of the Social Security Act, per § 1924(c)(3)(C), where the state determines that denial of eligibility on the basis of having excess resources would work an undue hardship.

d. State community property laws do not apply for purposes of post-eligibility treatment of income.

e. The spousal share is determined at the beginning of the first continuous period of institutionalization (beginning on or after September 30, 1989) of the institutionalized spouse.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-03-2.6113, eff. October 1, 1991.

12VAC30-40-345 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 16, Issue 15, eff. May 10, 2000; amended, Virginia Register Volume 17, Issue 3, eff. November 22, 2000; Volume 18, Issue 18, eff. July 1, 2002; Volume 20, Issue 22, eff. September 25, 2004; Volume 25, Issue 11, eff. March 19, 2009; repealed, Virginia Register Volume 33, Issue 21, eff. July 27, 2017.

12VAC30-40-347 Asset verification system

A. The agency is providing for the verification of assets for purposes of determining or redetermining Medicaid eligibility for aged, blind, and disabled Medicaid applicants and recipients using an asset verification system (AVS) that meets the following minimum requirements:

1. The request and response system is electronic.

a. Verification inquiries are sent electronically via the Internet or similar means from the agency to the financial institution.

b. The system is not based on mailing paper-based requests.

c. The system has the capability to accept responses electronically.

2. The system is secure, based on a recognized industry standard of security (e.g., as defined by the U.S. Commerce Department's National Institute of Standards and Technology (NIST)).

3. The system establishes and maintains a database of financial institutions that participate in the agency's AVS.

4. Verification requests are also sent to financial institutions other than those identified by applicants and recipients, based on some logic such as geographic proximity to the applicant's home address, or other reasonable factors whenever the agency determines that such requests are needed to determine or redetermine the individual's eligibility.

5. The verification request must include a request for information on both open and closed accounts, going back for a period up to five years, as determined by the Department of Medical Assistance Services.

B. System development.

1. The agency is hiring a contractor to develop an AVS.

2. AVS implementation information: Virginia is implementing a web-based asset verification system (AVS) as part of its Eligibility Modernization Project for implementing the mandatory provisions of health care reform. The selected contractors will provide an AVS that meets all requirements of the Centers for Medicare and Medicaid Services and § 1940 of the Social Security Act. It will be secure and meet all Medicaid Information Technology Architecture (MITA) standards.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 7, eff. January 3, 2013.

12VAC30-40-348 Adult group individual income-based determinations

A. Methodology for identification of applicable federal medical assistance percentages (FMAP) rates. DMAS will determine the appropriate FMAP rate for expenditures for individuals enrolled in the adult group described in 42 CFR 435.119 and receiving benefits in accordance with 42 CFR Part 440 Subpart C. The adult group FMAP methodology consists of two parts: an individual-based determination related to enrolled individuals and, as applicable, appropriate population-based adjustments.

B. Adult group individual income-based determinations. For individuals eligible in the adult group, the Commonwealth will make an individual income-based determination for purposes of the adult group FMAP methodology by comparing individual income to the relevant converted income eligibility standards in effect on December 1, 2009, and included in the Modified Adjusted Gross Income (MAGI) Conversion Plan (Part 2) approved by Centers for Medicare and Medicaid Services (CMS) on February 11, 2014. In general, and subject to any adjustments described in this section, under the adult group FMAP methodology, the expenditures of individuals with incomes below the relevant converted income standards for the applicable subgroup are considered as those for which the newly eligible FMAP is not available.

C. Population-based adjustments to the newly eligible population based on resource test, enrollment cap, or special circumstances.

1. The Commonwealth does not apply a resource proxy adjustment.

2. The Commonwealth does not apply an enrollment cap.

3. The Commonwealth does not apply a special circumstance adjustment.

4. The Commonwealth does not apply any additional adjustment to the adult group FMAP methodology.

D. Individuals previously eligible for Medicaid coverage through a § 1115 demonstration program or a mandatory or optional State Plan eligibility category will be transitioned to the new adult group described in 42 CFR 435.119 in accordance with a CMS-approved transition plan or a § 1902(e)(14)(A) waiver.

E. Applicability of special FMAP rates.

1. The Commonwealth does not meet the definition of an expansion state in 42 CFR 433.204(b).

2. The Commonwealth does not qualify for a temporary 2.2% increase in FMAP under 42 CFR 433.10(c)(7).

F. The Commonwealth attests to the following:

1. The application of the adult group FMAP methodology will not affect the timing or approval of any individual's eligibility for Medicaid.

2. The application of the adult group FMAP methodology will not be biased in such a manner as to inappropriately establish the numbers of, or medical assistance expenditures for, individuals determined to be newly or not newly eligible.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 38, Issue 12, eff. March 17, 2022.

Part V State Supplementary Payments

12VAC30-40-350 Standards for optional state supplementary payments

A. Aged, blind, and disabled recipients of optional state supplementary payments are eligible for medical assistance as categorically needy under this plan. The payments meet the four conditions specified in 45 CFR 248.2(d), that is, they are:

1. Regular, in cash, and based on need;

2. Available on a statewide basis;

3. Made to reasonable classifications of individuals who, except for the level of their income, would be eligible for an SSI payment; and

4. Equal to the difference between income and financial standards used to determine eligibility for the supplement.

B. A 15% differential above the maximum rate set forth in the appropriation act each year is established for residents in Planning District 8.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-02-2.6200; amended, Virginia Register Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-40-360 Treatment of entrance fees of individuals residing in continuing care retirement communities

When determining eligibility for medical assistance, an individual's entrance fee in a continuing care retirement community or life care community that collects an entrance fee on admission from such individuals shall be considered a resource available to the individual to the extent that:

1. The individual has the ability to use the entrance fee, or the contract provides that the entrance fee may be used, to pay for care should other resources or income of the individual be insufficient to pay for such care;

2. The individual is eligible for a refund of any remaining entrance fee when the individual dies or terminates the continuing care retirement community or life care community contract and leaves the community; and

3. The entrance fee does not confer an ownership interest in the continuing care retirement community or life care community.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 23, eff. August 23, 2006.

12VAC30-40-370 Variations from the basic personal needs allowance

For victims of Virginia's eugenical program, the Commonwealth shall, in addition to the basic personal needs allowance (PNA), increase the basic PNA by amounts received as payments for involuntary sterilization under the Virginia Eugenical Sterilization Act.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 33, Issue 19, eff. June 15, 2017.

Chapter 50 Amount, Duration, and Scope of Medical and Remedial Care Services

Part I Categorically Needy

12VAC30-50-10 Services provided to the categorically needy with limitations

The following services are provided with limitations as described in Part III (12VAC30-50-100 et seq.) of this chapter:

1. Inpatient hospital services other than those provided in an institution for mental diseases.

2. Outpatient hospital services.

3. Other laboratory and x-ray services; nonemergency outpatient Magnetic Resonance Imaging (MRI), including Magnetic Resonance Angiography (MRA), Computerized Axial Tomography (CAT) scans, including Computed Tomography Angiography (CTA), and Positron Emission Tomography (PET) scans performed for the purpose of diagnosing a disease process or physical injury require prior authorization.

4. Rural health clinic services and other ambulatory services furnished by a rural health clinic.

5. Federally Qualified Health Center (FQHC) services and other ambulatory services that are covered under the plan and furnished by an FQHC in accordance with § 4231 of the State Medicaid Manual (HCFA Pub. 45-4).

6. Early and periodic screening and diagnosis of individuals under 21 years of age, and treatment of conditions found.

7. Family planning services and supplies for individuals of child-bearing age.

8. Physicians' services whether furnished in the office, the patient's home, a hospital, a skilled nursing facility, or elsewhere.

9. Medical and surgical services furnished by a dentist (in accordance with § 1905(a)(5)(B) of the Act).

10. Medical care or any other type of remedial care recognized under state law, furnished by licensed practitioners within the scope of their practice as defined by state law: podiatrists, optometrists and other practitioners.

11. Home health services: intermittent or part-time nursing service provided by a home health agency or by a registered nurse when no home health agency exists in the area; home health aide services provided by a home health agency; and medical supplies, equipment, and appliances suitable for use in the home; physical therapy, occupational therapy, or speech pathology and audiology services provided by a home health agency or medical rehabilitation facility.

12. Clinic services.

13. Dental services.

14. Physical therapy and related services, including occupational therapy and services for individuals with speech, hearing, and language disorders (provided by or under supervision of a speech pathologist or audiologist).

15. Prescribed drugs, prosthetic devices, and eyeglasses prescribed by a physician skilled in diseases of the eye or by an optometrist.

16. Other rehabilitative services, screening services, preventive services.

17. Nurse-midwife services.

18. Case management services as defined in, and to the group specified in, 12VAC30-50-95 et seq. (in accordance with § 1905(a)(19) or § 1915(g) of the Act).

19. Extended services to pregnant women: pregnancy-related and postpartum services for a 60-day period after the pregnancy ends and any remaining days in the month in which the 60th day falls (see 12VAC30-50-510). (Note: Additional coverage beyond limitations.)

20. Pediatric or family nurse practitioners' service.

21. Any other medical care and any other type of remedial care recognized by state law, specified by the Secretary: transportation.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-02-3.1100, eff. June 16, 1993; amended, Virginia Register Volume 12, Issue 2, eff. November 15, 1995; Volume 14, Issue 4, eff. December 15, 1997; Volume 16, Issue 18, eff. July 1, 2000; Volume 20, Issue 1, eff. October 22, 2003; Volume 22, Issue 16, eff. July 3, 2006; Volume 25, Issue 14, eff. April 15, 2009.

12VAC30-50-20 Services provided to the categorically needy without limitation

The following services as described in Part III (12VAC30-50-100 et seq.) of this chapter are provided to the categorically needy without limitation:

1. Nursing facility services (other than services in an institution for mental diseases) for individuals 21 years of age or older.

2. Services for individuals 65 years of age or older in institutions for mental diseases: inpatient hospital services; skilled nursing facility services; and services in an intermediate care facility.

3. Intermediate care facility services (other than such services in an institution for mental diseases) for persons determined, in accordance with § 1902(a)(31)(A) of the Social Security Act (the Act), to be in need of such care, including such services in a public institution (or distinct part thereof) for persons with intellectual or developmental disability or related conditions.

4. Hospice care (in accordance with § 1905(o) of the Act).

5. Any other medical care and any type of remedial care recognized under state law, specified by the U.S. Secretary of Health and Human Services: care and services provided in religious nonmedical health care institutions, nursing facility services for patients younger than 21 years of age, or emergency hospital services.

6. Private health insurance premiums, coinsurance, and deductibles when cost effective (pursuant to P.L. No. 101-508 § 4402).

7. Program of All-Inclusive Care for the Elderly (PACE) services are provided for eligible individuals as an optional State Plan service for categorically needy individuals without limitation.

8. Pursuant to P.L. No. 111-148 § 4107, counseling and pharmacotherapy for cessation of tobacco use by pregnant women shall be covered.

a. Counseling and pharmacotherapy for cessation of tobacco use by pregnant women means diagnostic, therapy, and counseling services and pharmacotherapy (including the coverage of prescription and nonprescription tobacco cessation agents approved by the U.S. Food and Drug Administration) for cessation of tobacco use by pregnant women who use tobacco products or who are being treated for tobacco use that is furnished (i) by or under the supervision of a physician, (ii) by any other health care professional who is legally authorized to provide tobacco cessation services under state law and is authorized to provide Medicaid coverable services other than tobacco cessation services, or (iii) by any other health care professional who is legally authorized to provide tobacco cessation services under state law and who is specifically designated by the U.S. Secretary of Health and Human Services in federal regulations for this purpose.

b. No cost sharing shall be applied to these services. In addition to other services that are covered for pregnant women, 12VAC30-50-510 also provides for other smoking cessation services that are covered for pregnant women.

9. Inpatient psychiatric facility services and residential psychiatric treatment services (including therapeutic group homes and psychiatric residential treatment facilities) for individuals younger than 21 years of age.

10. Coverage of routine patient cost for items and services as defined in § 1905(gg) of the Social Security Act (42 USC § 1396 et seq.) that are furnished in connection with participation in a qualifying clinical trial.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia, 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-02-3.1100, eff. June 16, 1993; amended, Virginia Register Volume 12, Issue 2, eff. November 15, 1995; Volume 18, Issue 7, eff. January 16, 2002; Volume 20, Issue 1, eff. October 22, 2003; Volume 23, Issue 16, eff. July 1, 2007; Volume 29, Issue 11, eff. February 27, 2013; Volume 35, Issue 24, eff. August 22, 2019; Volume 39, Issue 5, eff. November 23, 2022.

12VAC30-50-30 Services not provided to the categorically needy

The following services and devices are not provided to the categorically needy:

1. Chiropractor services.

2. Private duty nursing services, unless an individual receives services under Early and Periodic Screening, Diagnosis, and Treatment Services or a § 1915(c) Waiver.

3. Dentures.

4. Other diagnostic and preventive services other than those provided elsewhere in this plan: diagnostic services (12VAC30-50-95).

5. (Reserved.)

6. Special tuberculosis related services under § 1902(z)(2)(F) of the Social Security Act (the Act).

7. Respiratory care services (in accordance with § 1920(e)(9)(A) through (C) of the Act).

8. Ambulatory prenatal care for pregnant women furnished during a presumptive eligibility period by a qualified provider (in accordance with § 1920 of the Act).

9. Any other medical care and any type of remedial care recognized under state law specified by the U.S. Secretary of Health and Human Services: personal care services in recipient's home, prescribed in accordance with a plan of treatment and provided by a qualified person under supervision of a registered nurse.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia, 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-02-3.1100, eff. June 16, 1993; amended, Virginia Register Volume 12, Issue 2, eff. November 15, 1995; Volume 14, Issue 4, eff. December 15, 1997; Volume 14, Issue 18, eff. July 1, 1998; Volume 17, Issue 5, eff. January 1, 2001; Volume 18, Issue 7, eff. January 16, 2002; Volume 35, Issue 24, eff. August 22, 2019; Volume 42, Issue 13, eff. March 26, 2026.

12VAC30-50-35 Requirements relating to payment for covered outpatient drugs for the categorically needy

A. Effective January 1, 2006, the Medicaid agency will not cover any Part D drug for full-benefit dual eligible individuals who are entitled to receive Medicare benefits under Part A or Part B.

The Medicaid agency provides coverage for the following excluded or otherwise restricted drugs or classes of drugs, or their medical uses to all Medicaid recipients, including full benefit dual eligible beneficiaries under the Medicare Prescription Drug Benefit-Part D. The following excluded drugs are covered:

1. Agents when used for anorexia, weight loss, or weight gain (see specific drug categories in subsection B of this section);

2. Agents when used for the symptomatic relief of cough and colds (see specific drug categories in subsection B of this section);

3. Prescription vitamins and mineral products, except prenatal vitamins and fluoride (see specific drug categories in subsection B of this section); and

4. Nonprescription drugs (see specific drug categories in subsection B of this section).

B. Coverage of specific categories of excluded drugs will be in accordance with existing Medicaid policy as described in 12VAC30-50-520.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 11, eff. March 7, 2007; amended, Virginia Register Volume 32, Issue 1, eff. October 22, 2015.

Part II Ambulatory Services; Medically Needy

12VAC30-50-40 Ambulatory services

The following ambulatory services are provided:

Physicians Services

Outpatient Hospital Services

Clinic Services

Laboratory and X-Ray Services

EPSDT Services

Family Planning Services

Optometrist Services

Home Health Services

Dental Services for those under age 21

Physical Therapy and Related Services

Prescribed Drugs

Eyeglass Services

Nurse Midwives

Outpatient Rehabilitation

Extended Services to Pregnant Women

Also provided are private health insurance premiums, coinsurance, and deductibles when cost-effective (pursuant to P.L. 101-508 § 4402).

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-03-3.1200, eff. June 16, 1993.

12VAC30-50-50 Services provided to the medically needy with limitations

Services as described in Part III (12VAC30-50-100 et seq.) of this chapter are provided to the medically needy with limitations.

1. Inpatient hospital services other than those provided in an institution for mental diseases.

2. Outpatient hospital services.

3. Other laboratory and x-ray services; nonemergency outpatient Magnetic Resonance Imaging (MRI), Computer Axial Tomography (CAT) scans, and Positron Emission Tomography (PET) scans require prior authorization.

4. Rural health clinic services and other ambulatory services furnished by a rural health clinic.

5. Federally qualified health center (FQHC) services and other ambulatory services that are covered under the plan and furnished by an FQHC in accordance with § 4231 of the State Medicaid Manual (HCFA, Pub. 45-4).

6. Family planning services and supplies for individuals of childbearing age.

7. Physicians' services whether furnished in the office, the patient's home, a hospital, a skilled nursing facility, or elsewhere.

8. Medical and surgical services furnished by a dentist (in accordance with § 1905(a)(5)(B) of the Act).

9. Medical care and any other type of remedial care recognized under state law, furnished by licensed practitioners within the scope of their practice as defined by state law, including:

a. Podiatrists' services;

b. Optometrists' services; and

c. Other practitioners' services.

10. Home health services' medical supplies, equipment, and appliances suitable for use in the home; intermittent or part-time nursing service provided by a home health agency or by a registered nurse when no home health agency exists in the area; home health aide services provided by a home health agency; physical therapy, occupational therapy, or speech pathology and audiology services provided by a home health agency or medical rehabilitation facility.

11. Clinic services.

12. Dental services.

13. Physical therapy, occupational therapy, and services for individuals with speech, hearing, and language disorders provided by or under supervision of a speech pathologist or audiologist.

14. Prescribed drugs, prosthetic devices, and eyeglasses prescribed by a physician skilled in diseases of the eye or by an optometrist.

15. Rehabilitative services.

16. Nurse-midwife services.

17. Case management services as defined in, and to the group specified in, 12VAC30-50-410 (in accordance with § 1905(a)(19) or § 1915(g) of the Act).

18. Extended services for pregnant women including pregnancy-related and post-partum services for 60 days after the pregnancy ends.

19. Certified pediatric or family nurse practitioners' services.

20. Any other medical care and any other type of remedial care recognized under state law, specified by the secretary, specifically transportation.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-03-3.1200, eff. June 16, 1993; amended, Virginia Register Volume 12, Issue 2, eff. November 15, 1995; Volume 12, Issue 3, eff. November 29, 1995; Volume 14, Issue 4, eff. December 15, 1997; Volume 20, Issue 1, eff. October 22, 2003.

12VAC30-50-60 Services provided to all medically needy groups without limitations

Services as described in Part III (12VAC30-50-100 et seq.) of this chapter are provided to all medically needy groups without limitations.

1. Nursing facility services (other than services in an institution for mental diseases) for individuals 21 years of age or older.

2. Early and periodic screening and diagnosis of individuals younger than 21 years of age, and treatment of conditions found.

3. Pursuant to P.L. No. 111-148 § 4107, counseling and pharmacotherapy for cessation of tobacco use by pregnant women shall be covered.

a. Counseling and pharmacotherapy for cessation of tobacco use by pregnant women means diagnostic, therapy, and counseling services and pharmacotherapy (including the coverage of prescription and nonprescription tobacco cessation agents approved by the U.S. Food and Drug Administration) for cessation of tobacco use by pregnant women who use tobacco products or who are being treated for tobacco use that is furnished (i) by or under the supervision of a physician, (ii) by any other health care professional who is legally authorized to provide tobacco cessation services under state law and is authorized to provide Medicaid coverable services other than tobacco cessation services, or (iii) by any other health care professional who is legally authorized to provide tobacco cessation services under state law and who is specifically designated by the U.S. Secretary of Health and Human Services in federal regulations for this purpose.

b. No cost sharing shall be applied to these services. In addition to other services that are covered for pregnant women, 12VAC30-50-510 also provides for other smoking cessation services that are covered for pregnant women.

4. Intermediate care facility services (other than such services in an institution for mental diseases) for persons determined in accordance with § 1905(a)(4)(A) of the Social Security Act (the Act) to be in need of such care.

5. Hospice care (in accordance with § 1905(o) of the Act).

6. Any other medical care or any other type of remedial care recognized under state law, specified by the U.S. Secretary of Health and Human Services, including: care and services provided in religious nonmedical health care institutions, skilled nursing facility services for patients younger than 21 years of age, and emergency hospital services.

7. Private health insurance premiums, coinsurance and deductibles when cost effective (pursuant to P.L. No. 101-508 § 4402).

8. Program of All-Inclusive Care for the Elderly (PACE) services are provided for eligible individuals as an optional State Plan service for medically needy individuals without limitation.

9. Inpatient psychiatric facility services and residential psychiatric treatment services (including therapeutic group homes and psychiatric residential treatment facilities) for individuals younger than 21 years of age.

10. Coverage of routine patient cost for items and services as defined in § 1905(gg) of the Social Security Act (42 USC § 1396 et seq.) that are furnished in connection with participation in a qualifying clinical trial.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia, 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-03-3.1200, eff. June 16, 1993; amended, Virginia Register Volume 12, Issue 2, eff. November 15, 1995; Volume 14, Issue 4, eff. December 15, 1997; Volume 18, Issue 7, eff. January 16, 2002; Volume 20, Issue 1, eff. October 22, 2003; Volume 23, Issue 16, eff. July 1, 2007; Volume 29, Issue 11, eff. February 27, 2013; Volume 35, Issue 24, eff. August 22, 2019; Volume 39, Issue 5, eff. November 23, 2022.

12VAC30-50-70 Services or devices not provided to the medically needy

The following services and devices shall not be provided to the medically needy:

1. Chiropractor services.

2. Private duty nursing services, unless an individual receives services under Early and Periodic Screening, Diagnosis, and Treatment Services or a § 1915(c) Waiver.

3. Dentures.

4. Diagnostic or preventive services other than those provided elsewhere in the State Plan.

5. Inpatient hospital services, skilled nursing facility services, and intermediate care facility services for individuals 65 years of age or older in institutions for mental diseases.

6. Intermediate care facility services (other than such services in an institution for mental diseases) for persons determined in accordance with § 1905(a)(4)(A) of the Social Security Act (the Act), to be in need of such care in a public institution, or a distinct part thereof, for persons with intellectual or developmental disability or related conditions.

7. (Reserved.)

8. Special tuberculosis services under § 1902(z)(2)(F) of the Act.

9. Respiratory care services in accordance with § 1920(e)(9)(A) through (C) of the Act.

10. Ambulatory prenatal care for pregnant women furnished during a presumptive eligibility period by a qualified provider in accordance with § 1920 of the Act.

11. Personal care services in a recipient's home, prescribed in accordance with a plan of treatment and provided by a qualified person under supervision of a registered nurse.

12. Home and community care for functionally disabled elderly individuals.

13. Personal care services furnished to an individual who is not an inpatient or resident of a hospital, nursing facility, intermediate care facility for intellectually or developmentally disabled persons, or institution for mental disease that are (i) authorized for the individual by a physician in accordance with a plan of treatment, (ii) provided by an individual who is qualified to provide such services and who is not a member of the individual's family, and (iii) furnished in a home.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia, 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-03-3.1200, eff. June 16, 1993; amended, Virginia Register Volume 12, Issue 2, eff. November 15, 1995; Volume 12, Issue 3, eff. November 29, 1995; Volume 14, Issue 18, eff. July 1, 1998; Volume 17, Issue 5, eff. January 1, 2001; Volume 18, Issue 7, eff. January 16, 2002; Volume 35, Issue 24, eff. August 22, 2019; Volume 41, Issue 19, eff. June 19, 2025; Volume 42, Issue 13, eff. March 26, 2026.

12VAC30-50-75 Requirements relating to payment for covered outpatient drugs for the medically needy

A. Effective January 1, 2006, the Medicaid agency will not cover any Part D drug for full-benefit dual eligible individuals who are entitled to receive Medicare benefits under Part A or Part B.

The Medicaid agency provides coverage for the following excluded or otherwise restricted drugs or classes of drugs, or their medical uses to all Medicaid recipients, including full benefit dual eligible beneficiaries under the Medicare Prescription Drug Benefit Part D. The following excluded drugs are covered:

1. Agents when used for anorexia, weight loss, or weight gain (see specific drug categories in subsection B of this section);

2. Agents when used for the symptomatic relief of cough and colds (see specific drug categories in subsection B of this section);

3. Prescription vitamins and mineral products, except prenatal vitamins and fluoride (see specific drug categories in subsection B of this section); and

4. Nonprescription drugs (see specific drug categories in subsection B of this section).

B. Coverage of specific categories of excluded drugs will be in accordance with existing Medicaid policy as described in 12VAC30-50-520.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 11, eff. March 7, 2007; amended, Virginia Register Volume 32, Issue 1, eff. October 22, 2015.

12VAC30-50-80 [Reserved]. (Reserved)

12VAC30-50-95 Reimbursement of services; in general

The provision of the following medically necessary services cannot be reimbursed except when they are ordered or prescribed, and directed or performed within the scope of the license of a practitioner of the healing arts: laboratory and x-ray services, family planning services, and home health services. Physical therapy services will be reimbursed only when prescribed by a physician. Inpatient acute hospitalizations will be reimbursed only if the stay has been authorized.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 3, eff. November 29, 1995; amended, Virginia Register Volume 14, Issue 7, eff. January 21, 1998.

Part III Amount, Duration, and Scope of Services

12VAC30-50-100 Inpatient hospital services provided at general acute care hospitals and freestanding psychiatric hospitals; enrolled providers

A. Service authorization of all inpatient hospital services will be performed. This applies to both general acute care hospitals and freestanding psychiatric hospitals. Nonauthorized inpatient services will not be covered or reimbursed by the Department of Medical Assistance Services (DMAS) or its contractor. Service authorization shall be based on criteria specified by DMAS.

1. Admission review.

a. Planned/scheduled admissions. Review shall be done prior to admission to determine that inpatient hospitalization is medically justified. An initial length of stay shall be assigned at the time of this review. Adverse authorization decisions shall have available a reconsideration process as set out in subdivision 4 of this subsection.

b. Unplanned/urgent or emergency admissions. These admissions will be permitted before any service authorization procedures. Review shall be performed within one working day to determine that inpatient hospitalization is medically justified. An initial length of stay shall be assigned for those admissions which have been determined to be appropriate. Adverse authorization decisions shall have available a reconsideration process as set out in subdivision 4 of this subsection.

2. Concurrent review shall end for nonpsychiatric claims with dates of admission and services on or after July 1, 1998, with the full implementation of the DRG reimbursement methodology. Concurrent review shall be done to determine that inpatient hospitalization continues to be medically necessary. Prior to the expiration of the previously assigned initial length of stay, the provider shall be responsible for obtaining authorization for continued inpatient hospitalization. If continued inpatient hospitalization is determined necessary, an additional length of stay shall be assigned. Concurrent review shall continue in the same manner until the discharge of the patient from acute inpatient hospital care. Adverse authorization decisions shall have available a reconsideration process as set out in subdivision 4 of this subsection.

3. Retrospective review shall be performed when a provider is notified of a patient's retroactive eligibility for Medicaid coverage. It shall be the provider's responsibility to obtain authorization for covered days prior to billing DMAS for these services. Adverse authorization decisions shall have available a reconsideration process as set out in subdivision 4 of this subsection.

4. Reconsideration process. Providers shall be given the opportunity to request a reconsideration of any adverse service authorization decision. Reconsideration requests shall be reviewed by a physician. Should the case be denied, the member or provider may request an appeal by following the procedures described in the denial letter.

5. Appeals process.

a. Recipient appeals. Upon receipt of a denial letter, the recipient shall have the right to appeal the adverse decision. Under the Client Appeals regulations, Part I (12VAC30-110-10 et seq.) of 12VAC30-110, the recipient shall have 30 days from the date of the denial letter to file an appeal.

b. Provider appeals. If the reconsideration steps are exhausted and the provider continues to disagree, upon receipt of the denial letter, the provider shall have 30 days from the date of the denial letter to file an appeal if the issue is whether DMAS will reimburse the provider for services already rendered. The appeal shall be held in accordance with the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

B. Out-of-state inpatient general acute care hospitals and freestanding psychiatric hospitals, enrolled providers. In addition to meeting all of the service authorization requirements specified in subsection A of this section, out-of-state hospitals must further demonstrate that the requested admission meets at least one of the following additional standards. Services provided out of state for circumstances other than these specified reasons shall not be covered.

1. The medical services must be needed because of a medical emergency;

2. Medical services must be needed and the recipient's health would be endangered if he were required to travel to his state of residence;

3. The state determines, on the basis of medical advice, that the needed medical services, or necessary supplementary resources, are more readily available in the other state; or

4. It is the general practice for recipients in a particular locality to use medical resources in another state.

C. Cosmetic surgical procedures shall not be covered unless performed for physiological reasons and require DMAS prior approval.

D. Reimbursement for induced abortions is provided in only those cases in which there would be a substantial endangerment to life of the mother if the fetus were carried to term.

E. Mandatory lengths of stay.

1. Coverage for a normal, uncomplicated vaginal delivery shall be limited to the day of delivery plus an additional two days unless additional days are medically justified. Coverage for cesarean births shall be limited to the day of delivery plus an additional four days unless additional days are medically justified.

2. Coverage for a radical or modified radical mastectomy for treatment of disease or trauma of the breast shall be provided for a minimum of 48 hours. Coverage for a total or partial mastectomy with lymph node dissection for treatment of disease or trauma of the breast shall be provided for a minimum of 24 hours. Additional days beyond the specified minimums for either radical, modified, total, or partial mastectomies may be covered if medically justified and prior authorized until the diagnosis related grouping methodology is fully implemented. Nothing in this chapter shall be construed as requiring the provision of inpatient coverage where the attending physician in consultation with the patient determines that a shorter period of hospital stay is appropriate.

F. Coverage in freestanding psychiatric hospitals shall not be available for individuals aged 21 through 64. Medically necessary inpatient psychiatric care rendered in a psychiatric unit of a general acute care hospital shall be covered for all Medicaid eligible individuals, regardless of age, within the limits of coverage prescribed in this section and 12VAC30-50-105.

G. For the purposes of organ transplantation, all similarly situated individuals will be treated alike. Transplant services for kidneys, corneas, hearts, lungs, and livers shall be covered for all eligible persons. High dose chemotherapy and bone marrow/stem cell transplantation shall be covered for all eligible persons with a diagnosis of lymphoma, breast cancer, leukemia, or myeloma. Transplant services for any other medically necessary transplantation procedures that are determined to not be experimental or investigational shall be limited to children (under 21 years of age). Kidney, liver, heart, and bone marrow/stem cell transplants and any other medically necessary transplantation procedures that are determined to not be experimental or investigational require service authorization by DMAS medical support. Inpatient hospitalization related to kidney transplantation will require service authorization at the time of admission and, concurrently, for length of stay. Cornea transplants do not require service authorization of the procedure, but inpatient hospitalization related to such transplants will require service authorization for admission and, concurrently, for length of stay. The patient must be considered acceptable for coverage and treatment. The treating facility and transplant staff must be recognized as being capable of providing high quality care in the performance of the requested transplant. Standards for coverage of organ transplant services are in 12VAC30-50-540 through 12VAC30-50-580.

H. In compliance with federal regulations at 42 CFR 441.200, Subparts E and F, claims for hospitalization in which sterilization, hysterectomy, or abortion procedures were performed shall be subject to review. Hospitals must submit the required DMAS forms corresponding to the procedures. Regardless of authorization for the hospitalization during which these procedures were performed, the claims shall suspend for manual review by DMAS. If the forms are not properly completed or not attached to the bill, the claim will be denied or reduced according to DMAS policy.

I. Addiction and recovery treatment services shall be covered in inpatient facilities consistent with 12VAC30-130-5000 et seq.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-03-3.1100 § 1, eff. July 1, 1991; amended, eff. September 1, 1991; amended, eff. July 19, 1993; amended, Virginia Register Volume 10, Issue 18, eff. July 14, 1994; Volume 11, Issue 13, eff. April 19, 1995; Volume 13, Issue 1, eff. November 1, 1996; Volume 14, Issue 7, eff. January 21, 1998; Volume 14, Issue 18, eff. July 1, 1998; Volume 14, Issue 25, eff. September 30, 1998; Volume 15, Issue 24, eff. September 15, 1999; Volume 16, Issue 18, eff. July 1, 2000; Volume 18, Issue 6, eff. January 2, 2002; Volume 18, Issue 7, eff. January 16, 2002; Volume 26, Issue 19, eff. July 1, 2010; Volume 33, Issue 12, eff. April 1, 2017; Volume 37, Issue 2, eff. October 30, 2020.

12VAC30-50-105 Inpatient hospital services provided at general acute care hospitals and freestanding psychiatric hospitals; nonenrolled providers (nonparticipating/out of state)

A. The full DRG inpatient reimbursement methodology shall become effective July 1, 1998, for general acute care hospitals and freestanding psychiatric hospitals which are nonenrolled providers (nonparticipating/out of state) and the same reviews, criteria, and requirements shall apply as are applied to enrolled, in-state, participating hospitals in 12VAC30-50-100.

B. Inpatient hospital services rendered by nonenrolled providers shall not require service authorization with the exception of transplants as described in subsection I of this section and this subsection. However, these inpatient hospital services claims will be suspended from automated computer payment and will be manually reviewed for medical necessity as described in subsections B through I of this section using criteria specified by DMAS. Inpatient hospital services provided out of state to a Medicaid recipient who is a resident of the Commonwealth of Virginia shall only be reimbursed under at least one of the following conditions. It shall be the responsibility of the hospital, when requesting service authorization for the admission, to demonstrate that one of the following conditions exists in order to obtain authorization.

1. The medical services must be needed because of a medical emergency;

2. Medical services must be needed and the recipient's health would be endangered if he were required to travel to his state of residence;

3.The state determines, on the basis of medical advice, that the needed medical services, or necessary supplementary resources, are more readily available in the other state;

4. It is the general practice for recipients in a particular locality to use medical resources in another state.

C. Cosmetic surgical procedures shall not be covered unless performed for physiological reasons and require DMAS prior approval.

D. Reimbursement for induced abortions is provided in only those cases in which there would be a substantial endangerment to life of the mother if the fetus was carried to term.

E. Hospital claims with an admission date prior to the first surgical date, regardless of the number of days prior to surgery, must be medically justified. The hospital must write on or attach the justification to the billing invoice for consideration of reimbursement for all pre-operative days. Medically justified situations are those where appropriate medical care cannot be obtained except in an acute hospital setting thereby warranting hospital admission. Medically unjustified days in such admissions will be denied.

F. The admission and length of stay must be medically justified and service authorized via the admission and concurrent review processes described in subsection A of 12VAC30-50-100. Medically unjustified days in such hospitalizations shall not be reimbursed by DMAS.

G. Mandatory lengths of stay.

1. Coverage for a normal, uncomplicated vaginal delivery shall be limited to the day of delivery plus an additional two days unless additional days are medically justified. Coverage for cesarean births shall be limited to the day of delivery plus an additional four days unless additional days are medically necessary.

2. Coverage for a radical or modified radical mastectomy for treatment of disease or trauma of the breast shall be provided for a minimum of 48 hours. Coverage for a total or partial mastectomy with lymph node dissection for treatment of disease or trauma of the breast shall be provided for a minimum of 24 hours. Additional days beyond the specified minimums for either radical, modified, total, or partial mastectomies may be covered if medically justified and prior authorized until the diagnosis related grouping methodology is fully implemented. Nothing in this chapter shall be construed as requiring the provision of inpatient coverage where the attending physician in consultation with the patient determines that a shorter period of hospital stay is appropriate.

H. Reimbursement will not be provided for inpatient hospitalization for those surgical and diagnostic procedures listed on the DMAS outpatient surgery list unless the inpatient stay is medically justified or meets one of the exceptions.

I. For purposes of organ transplantation, all similarly situated individuals will be treated alike. Transplant services for kidneys, corneas, hearts, lungs, and livers shall be covered for all eligible persons. High dose chemotherapy and bone marrow/stem cell transplantation shall be covered for all eligible persons with a diagnosis of lymphoma, breast cancer, leukemia, or myeloma. Transplant services for any other medically necessary transplantation procedures that are determined to not be experimental or investigational shall be limited to children (under 21 years of age). Kidney, liver, heart, bone marrow/stem cell transplants and any other medically necessary transplantation procedures that are determined to not be experimental or investigational require service authorization by DMAS. Cornea transplants do not require service authorization. The patient must be considered acceptable for coverage and treatment. The treating facility and transplant staff must be recognized as being capable of providing high quality care in the performance of the requested transplant. Standards for coverage of organ transplant services are in 12VAC30-50-540 through 12VAC30-50-580.

J. In compliance with 42 CFR 441.200, Subparts E and F, claims for hospitalization in which sterilization, hysterectomy, or abortion procedures were performed shall be subject to review of the required DMAS forms corresponding to the procedures. The claims shall suspend for manual review by DMAS. If the forms are not properly completed or not attached to the bill, the claim will be denied or reduced according to DMAS policy.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 14, Issue 7, eff. January 21, 1998; amended, Virginia Register Volume 14, Issue 18, eff. July 1, 1998; Volume 14, Issue 25, eff. September 30, 1998; Volume 15, Issue 24, eff. September 15, 1999; Volume 16, Issue 18, eff. July 1, 2000; Volume 18, Issue 6, eff. January 2, 2002; Volume 18, Issue 7, eff. January 16, 2002; Volume 26, Issue 19, eff. July 1, 2010; Volume 37, Issue 2, eff. October 30, 2020.

12VAC30-50-110 Outpatient hospital and rural health clinic services

A. Outpatient hospital services.

1. Outpatient hospital services means preventive, diagnostic, therapeutic, rehabilitative, or palliative services that:

a. Are furnished to outpatients;

b. Except in the case of nurse-midwife services, as specified in 42 CFR 440.165, are furnished by or under the direction of a physician or dentist; and

c. Are furnished by an institution that:

(1) Is licensed or formally approved as a hospital by an officially designated authority for state standard-setting; and

(2) Except in the case of medical supervision of nurse-midwife services, as specified in 42 CFR 440.165, meets the requirements for participation in Medicare.

2. Reimbursement for induced abortions is provided in only those cases in which there would be substantial endangerment of life to the mother if the fetus was carried to term.

3. The following limits and requirements shall apply to DMAS coverage of outpatient observation beds.

a. Observation bed services shall be covered when they are reasonable and necessary to evaluate a medical condition to determine appropriate level of treatment.

b. Nonroutine observation for underlying medical complications, as explained in documentation attached to the provider's claim for payment, after surgery or diagnostic services shall be covered. Routine use of an observation bed shall not be covered. Noncovered routine use shall be:

(1) Routine preparatory services and routine recovery time for outpatient surgical or diagnostic testing services (e.g., services for routine post-operative monitoring during a normal recovery period (four to six hours)).

(2) Observation services provided in conjunction with emergency room services, unless, following the emergency treatment, there are clear medical complications which must be managed by a physician other than the original emergency physician.

(3) Any substitution of an outpatient observation service for a medically appropriate inpatient admission.

c. These services must be billed as outpatient care and may be provided for up to 23 hours. A patient stay of 24 hours or more shall require inpatient precertification, where applicable.

d. When inpatient admission is required following observation services and prior approval has been obtained for the inpatient stay, observation charges must be combined with the appropriate inpatient admission and be shown on the inpatient claim for payment. Observation bed charges and inpatient hospital charges shall not be reimbursed for the same day.

4. Addiction and recovery treatment services shall be covered in outpatient hospital facilities consistent with 12VAC30-130-5000 et seq.

B. Rural health clinic services and other ambulatory services furnished by a rural health clinic.

1. The same service limitations apply to rural health clinics as to all other services.

2. Addiction and recovery treatment services shall be covered in rural health clinics consistent with 12VAC30-130-5000 et seq.

C. Federally qualified health center (FQHC) services and other ambulatory services that are covered under the plan and furnished by an FQHC in accordance with § 4231 of the State Medicaid Manual (HCFA-Pub. 45‑4).

1. The same service limitations apply to FQHCs as to all other services.

2. Addiction and recovery treatment services shall be covered in FQHCs consistent with 12VAC30-130-5000 et seq.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-03-3.1100 § 2, eff. November 7, 1990; amended, eff. June 30, 1993; amended, Virginia Register Volume 8, Issue 14, eff. April 1, 1992; amended, Volume 10, Issue 22, eff. September 1, 1994; amended, Volume 11, Issue 17, eff. July 1, 1995; Volume 15, Issue 5, eff. January 1, 1999; Volume 26, Issue 19, eff. July 1, 2010; Volume 33, Issue 12, eff. April 1, 2017.

12VAC30-50-120 Other laboratory and x-ray services

A. Services must be ordered or prescribed and directed or performed within the scope of a license of the practitioner of the healing arts.

B. Prior authorization is required for the following nonemergency outpatient procedures: Magnetic Resonance Imaging (MRI), including Magnetic Resonance Angiography (MRA), Computerized Axial Tomography (CAT) scans, including Computed Tomography Angiography (CTA), or Positron Emission Tomography (PET) scans performed for the purpose of diagnosing a disease process or physical injury. The referring physician ordering the scan must obtain the prior authorization in order for the servicing provider to be reimbursed for the scan. Nonemergency outpatient MRI, CAT and PET scans that are not prior authorized will not be covered or reimbursed by the Department of Medical Assistance Services (DMAS).

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-03-3.1100 § 3, eff. June 30, 1993; amended, Virginia Register Volume 10, Issue 22, eff. September 1, 1994; Volume 20, Issue 1, eff. October 22, 2003; Volume 22, Issue 16, eff. July 3, 2006.

12VAC30-50-130 Nursing facility services, EPSDT, including school health services and family planning

A. Nursing facility services (other than services in an institution for mental diseases) for individuals 21 years of age or older. Service must be ordered or prescribed and directed or performed within the scope of a license of the practitioner of the healing arts.

B. General provisions for early and periodic screening, diagnosis, and treatment (EPSDT) of individuals younger than 21 years of age, and treatment of conditions found.

1. Payment of medical assistance services shall be made on behalf of individuals younger than 21 years of age who are Medicaid eligible for medically necessary stays in acute care facilities and the accompanying attendant physician care in excess of 21 days per admission when such services are rendered for the purpose of diagnosis and treatment of health conditions identified through a physical examination.

2. Reserved.

3. Orthoptics services shall only be reimbursed if medically necessary to correct a visual defect identified by an EPSDT examination or evaluation. DMAS shall place appropriate utilization controls upon this service.

4. Consistent with § 6403 of the Omnibus Budget Reconciliation Act of 1989, early and periodic screening, diagnostic, and treatment services means the following services: screening services, vision services, dental services, hearing services, and such other necessary health care, diagnostic services, treatment, and other measures described in Social Security Act § 1905(a) to correct or ameliorate defects and physical and mental illnesses and conditions discovered by the screening services and that are medically necessary, whether or not such services are covered under the State Plan and notwithstanding the limitations, applicable to recipients 21 years of age and older, provided for by § 1905(a) of the Social Security Act.

C. Community mental health services provided through early and periodic screening diagnosis and treatment (EPSDT) for individuals younger than 21 years of age. These services in order to be covered (i) shall meet medical necessity criteria based upon diagnoses made by LMHPs, LMHP-Rs, LMHP-RPs, and LMHP-Ss who are practicing within the scope of their licenses and (ii) shall be reflected in provider records and on providers' claims for services by recognized diagnosis codes that support and are consistent with the requested professional services.

1. Definitions. The following words and terms when used in this section shall have the following meanings unless the context clearly indicates otherwise:

"Care coordination" means the collaboration and sharing of information among health care providers involved with an individual's health care to improve the care.

"Caregiver" means the same as defined in 12VAC30-130-5160.

"Child" means an individual ages birth through 11 years.

"Comprehensive needs assessment" means the face-to-face interaction in which the provider obtains information from the youth and parent or other family member, as appropriate, about the youth's mental health status. Requirements for the comprehensive needs assessment are set out in 12VAC30-60-143.

"DBHDS" means the Department of Behavioral Health and Developmental Services.

"Direct supervisor" means the person who provides direct supervision to the peer recovery specialist. The direct supervisor (i) shall have two consecutive years of documented practical experience rendering peer support services or family support services, have certification training as a PRS under a certifying body approved by DBHDS, and have documented completion of the DBHDS PRS supervisor training; (ii) shall be a qualified mental health professional (QMHP-A, QMHP-C, or QMHP-E) as defined in 12VAC35-105-20 with at least two consecutive years of documented experience as a QMHP, and who has documented completion of the DBHDS PRS supervisor training; or (iii) shall be an LMHP, LMHP-R, LMHP-RP, or LMHP-S who has documented completion of the DBHDS PRS supervisor training who is acting within his scope of practice under state law.

"DMAS" means the Department of Medical Assistance Services and its contractors.

"EPSDT" means early and periodic screening, diagnosis, and treatment.

"Family support partners" means the same as defined in 12VAC30-130-5170.

"Individual service plan" or "ISP" means the same as the term is defined in 12VAC30-50-226.

"Licensed mental health professional" or "LMHP" means the same as defined in 12VAC35-105-20.

"LMHP-resident" or "LMHP-R" means the same as "resident" as defined in (i) 18VAC115-20-10 for licensed professional counselors; (ii) 18VAC115-50-10 for licensed marriage and family therapists; or (iii) 18VAC115-60-10 for licensed substance abuse treatment practitioners. An LMHP-resident shall be in continuous compliance with the regulatory requirements of the applicable counseling profession for supervised practice and shall not perform the functions of the LMHP-R or be considered a "resident" until the supervision for specific clinical duties at a specific site has been preapproved in writing by the Virginia Board of Counseling.

"LMHP-resident in psychology" or "LMHP-RP" means the same as an individual in a residency, as that term is defined in 18VAC125-20-10, program for clinical psychologists. An LMHP-resident in psychology shall be in continuous compliance with the regulatory requirements for supervised experience as found in 18VAC125-20-65 and shall not perform the functions of the LMHP-RP or be considered a "resident" until the supervision for specific clinical duties at a specific site has been preapproved in writing by the Virginia Board of Psychology.

"LMHP-supervisee in social work," "LMHP-supervisee," or "LMHP-S" means the same as "supervisee" as defined in 18VAC140-20-10 for licensed clinical social workers. An LMHP-supervisee in social work shall be in continuous compliance with the regulatory requirements for supervised practice as found in 18VAC140-20-50 and shall not perform the functions of the LMHP-S or be considered a "supervisee" until the supervision for specific clinical duties at a specific site is preapproved in writing by the Virginia Board of Social Work.

"Peer recovery specialist" or "PRS" means the same as defined in 12VAC30-130-5160.

"Peer recovery support services" means the same as defined in 12VAC35-250-10.

"Person centered" means the same as defined in 12VAC30-130-5160.

"Progress notes" means individual-specific documentation that contains the unique differences particular to the individual's circumstances, treatment, and progress that is also signed and contemporaneously dated by the provider's professional staff who have prepared the notes. Individualized and member-specific progress notes are part of the minimum documentation requirements and shall convey the individual's status, staff interventions, and, as appropriate, the individual's progress, or lack of progress, toward goals and objectives in the ISP.

"Psychoeducation" means (i) a specific form of education aimed at helping youth who have mental illness and their family members or caregivers to access clear and concise information about mental illness and (ii) a way of accessing and learning strategies to deal with mental illness and its effects in order to design effective treatment plans and strategies.

"Qualified mental health professional-child" or "QMHP-C" means the same as the term is defined in § 54.1-3500 of the Code of Virginia.

"Qualified mental health professional-eligible" or "QMHP-E" means the same as "qualified mental health professional – trainee" as defined in § 54.1-3500 of the Code of Virginia.

"Recovery-oriented services" means the same as defined in 12VAC30-130-5160.

"Recovery, resiliency, and wellness plan" means the same as defined in 12VAC30-130-5160.

"Resiliency" means the same as defined in 12VAC30-130-5160.

"Self-advocacy" means the same as defined in 12VAC30-130-5160.

"Strength-based" means the same as defined in 12VAC30-130-5160.

"Supervision" means the same as defined in 12VAC30-130-5160.

"Youth" means an individual younger than 21 years of age.

2. Intensive in-home services (IIH) to youth shall be time-limited interventions provided in the youth's residence and when clinically necessary in community settings. All interventions and the settings of the intervention shall be defined in the Individual Service Plan. All IIH services shall be designed to specifically improve family dynamics and provide modeling and the clinically necessary interventions that increase functional and therapeutic interpersonal relations between family members in the home. IIH services are designed to promote psychoeducational benefits in the home setting of a youth who is at risk of being moved into an out-of-home placement or who is being transitioned to home from an out-of-home placement due to a documented medical need of the youth. These services provide crisis treatment; individual and family counseling; communication skills (e.g., counseling to assist the youth and the youth's parents or guardians, as appropriate, to understand and practice appropriate problem solving, anger management, and interpersonal interaction, etc.); care coordination with other required services; and 24-hour emergency response.

a. Service authorization shall be required for Medicaid reimbursement prior to the onset of services. Services rendered before the date of authorization shall not be reimbursed.

b. Services must be recommended as part of a comprehensive needs assessment prior to the start of services. ISPs shall be required during the entire duration of services. Services based upon incomplete, missing, or outdated comprehensive needs assessments or ISPs shall be denied reimbursement. Requirements for comprehensive needs assessments and ISPs are set out in 12VAC30-60-61.

c. These services shall only be rendered by an LMHP, LMHP-supervisee, LMHP-resident, LMHP-RP, a QMHP-C, or a QMHP-E.

3. Therapeutic day treatment (TDT) shall be provided two or more hours per day in order to provide therapeutic interventions (a unit is defined in 12VAC30-60-61 D 11). Day treatment programs provide evaluation; medication education and management; opportunities to learn and use daily living skills and to enhance social and interpersonal skills (e.g., problem solving, anger management, community responsibility, increased impulse control, and appropriate peer relations, etc.); and individual, group, and family counseling.

a. Service authorization shall be required for Medicaid reimbursement.

b. Services must be recommended as part of a comprehensive needs assessment prior to the start of services. ISPs shall be required during the entire duration of services. Services based upon incomplete, missing, or outdated comprehensive needs assessments or ISPs shall be denied reimbursement. Requirements for comprehensive needs assessments and ISPs are set out in 12VAC30-60-61.

c. These services shall be rendered only by an LMHP, LMHP-supervisee, LMHP-resident, LMHP-RP, a QMHP-C, or a QMHP-E.

D. Therapeutic group home services and psychiatric residential treatment facility (PRTF) services for early and periodic screening diagnosis and treatment (EPSDT) of youth.

1. Definitions. The following words and terms when used in this subsection shall have the following meanings:

"Active treatment" means implementation of an initial plan of care (IPOC) and comprehensive individual plan of care (CIPOC).

"Activities of daily living" or "ADL" means personal care activities and includes bathing, dressing, transferring, toileting, feeding, and eating.

"Activities of daily living restoration" or "ADL restoration" means a face-to-face interaction provided on an individual or group basis to assist youth in the restoration of lost ADL skills that are necessary to achieve the goals established in the youth's plan of care. Services address performance deficits related to a lack of physical, cognitive, or psychosocial skills which hinder the ability of the youth to complete ADLs. Services include (i) restoring acceptable habits, behaviors, and attitudes related to daily health activities and personal care or hygiene and (ii) assisting the youth restoring and regaining functional ADL skills and appropriate behavior related to health and safety.

"ADL supervisor" means a child care supervisor with a baccalaureate degree in social work or psychology and two years of professional experience working with children one year of which must have been in a residential facility for children; or a high school diploma or General Education Development Certificate (GED) and a minimum of five years professional experience working with children with at least two years in a residential facility for children.

"ADL technician" means a child care worker at least 21 years of age who has a baccalaureate degree in human services (as defined by the Department of Health Professions); has an associate's degree and three months experience working with children; or is a high school graduate or has a GED and has six months of experience working with children. A trainee with a high school diploma or a GED may count experience working directly alongside a staff member who is, at a minimum, an ADL technician with at least one year of professional experience with children if the trainee is within sight and sound of the supervising staff member and does not work alone. An individual can only be classified as an ADL technician if they are supervised by an ADL supervisor, QMHP-C, LMHP, LMHP-R, LMHP-RP, or LMHP-S.

"Assessment" means the face-to-face interaction by an LMHP, LMHP-R, LMHP-RP, or LMHP-S to obtain information from the youth and parent, guardian, or other family member, as appropriate, utilizing a tool or series of tools to provide a comprehensive evaluation and review of the youth's mental health status. The assessment shall include a documented history of the severity, intensity, and duration of mental health problems and behavioral and emotional issues.

"Certificate of need" or "CON" means a written statement by an independent certification team that services in a therapeutic group home or PRTF are or were needed.

"Comprehensive individual plan of care" or "CIPOC" means a person centered plan of care that meets all of the requirements of this subsection and is specific to the youth's unique treatment needs and acuity levels as identified in the clinical assessment and information gathered during the referral process.

"Crisis" means a deteriorating or unstable situation that produces an acute, heightened emotional, mental, physical, medical, or behavioral event.

"Crisis management" means immediately provided activities and interventions designed to rapidly manage a crisis. The activities and interventions include behavioral health care to provide immediate assistance to youth experiencing acute behavioral health problems that require immediate intervention to stabilize and prevent harm and higher level of acuity. Activities shall include assessment and short-term counseling designed to stabilize the youth. Youth are referred to long-term services once the crisis has been stabilized.

"Daily supervision" means the supervision provided in a PRTF through a resident-to-staff ratio approved by the Office of Licensure at the Department of Behavioral Health and Developmental Services with documented supervision checks every 15 minutes throughout a 24-hour period.

"Discharge planning" means family and locality-based care coordination that begins upon admission to a PRTF or therapeutic group home with the goal of transitioning the youth out of the PRTF or therapeutic group home to a less restrictive care setting with continued, clinically-appropriate services as soon as possible upon discharge. Discharge plans shall be recommended by the treating physician, psychiatrist, or treating LMHP responsible for the overall supervision of the plan of care and shall be approved by the DMAS contractor.

"DSM-5" means the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, copyright 2013, American Psychiatric Association.

"Emergency admissions" means admissions that are made when, pending a review for the certificate of need, it appears that the youth is in need of an immediate admission to a therapeutic group home or PRTF and likely does not meet the medical necessity criteria to receive crisis intervention, crisis stabilization, or acute psychiatric inpatient services.

"Family engagement" means a family-centered and strengths-based approach to partnering with families in making decisions, setting goals, achieving desired outcomes, and promoting safety, permanency, and well-being for youth and families. Family engagement requires ongoing opportunities for a youth to build and maintain meaningful relationships with family members, for example, frequent, unscheduled, and noncontingent telephone calls and visits between the youth and family members. Family engagement may also include enhancing or facilitating the development of the youth's relationship with other family members and supportive adults responsible for the youth's care and well-being upon discharge.

"Family engagement activity" means an intervention consisting of family psychoeducational training or coaching, transition planning with the family, family and independent living skills, and training on accessing community supports as identified in the plan of care. Family engagement activity does not include and is not the same as family therapy.

"Family therapy" means counseling services involving the youth's family and significant others to advance the treatment goals when (i) the counseling with the family member and significant others is for the direct benefit of the youth, (ii) the counseling is not aimed at addressing treatment needs of the youth's family or significant others, and (iii) the youth is present except when it is clinically appropriate for the youth to be absent in order to advance the youth's treatment goals. Family therapy shall be aligned with the goals of the youth's plan of care. All family therapy services furnished are for the direct benefit of the youth, in accordance with the youth's needs and treatment goals identified in the youth's plan of care, and for the purpose of assisting in the youth's recovery.

"FAPT" means the family assessment and planning team.

"ICD-10" means International Statistical Classification of Diseases and Related Health Problems, 10th Revision, published by the World Health Organization.

"Independent certification team" means a team that has competence in diagnosis and treatment of mental illness, preferably in child and adolescent psychiatry; has knowledge of the youth's situation; and is composed of at least one physician and one LMHP, LMHP-R, LMHP-RP, or LMHP-S. The independent certification team shall be a DMAS-authorized contractor with contractual or employment relationships with the required team members.

"Initial plan of care" or "IPOC" means a person centered plan of care established at admission that meets all of the requirements of this subsection and is specific to the youth's unique treatment needs and acuity levels as identified in the clinical assessment and information gathered during the referral process.

"Intervention" means scheduled therapeutic treatment included in the individualized plan of care to help the youth achieve the youth's plan of care goals and objectives. Interventions may include individual or group psychoeducation; skills restoration; ADL restoration; individual, group, and family therapy; structured behavior support and training activities; recreation, art, and music therapies; community integration activities that promote or assist in the youth's ability to acquire coping and functional or self-regulating behavior skills; therapeutic passes; and family engagement activities. Interventions shall not include medical or dental appointments, physician services, medication evaluation, or management provided by a licensed clinician or physician and shall not include school attendance. Interventions are provided in the therapeutic group home or PRTF and, when clinically necessary, may occur in a community setting or as part of a therapeutic pass if the setting is documented in the plan of care.

"Plan of care" means the initial plan of care (IPOC) and the comprehensive individual plan of care (CIPOC).

"Physician" means an individual licensed to practice medicine or osteopathic medicine in Virginia, as defined in § 54.1-2900 of the Code of Virginia.

"Psychiatric residential treatment facility" or "PRTF" means the same as defined in 42 CFR 483.352 and is a 24-hour, supervised, clinically and medically necessary, out-of-home active treatment program designed to provide necessary support and address mental health, behavioral, substance abuse, cognitive, and training needs of a youth in order to prevent or minimize the need for more intensive treatment.

"Psychotherapy" or "therapy" means the use of psychological methods in a professional relationship to assist a person to acquire great human effectiveness or to modify feelings, conditions, attitudes, and behaviors that are emotionally, intellectually, or socially ineffectual or maladaptive.

"Recertification" means a certification for each applicant or recipient for whom therapeutic group home or PRTF services are needed.

"Room and board" means a component of the total daily cost for placement in a licensed PRTF. Residential room and board costs are maintenance costs associated with placement in a licensed PRTF and include a semi-private room, three meals and two snacks per day, and personal care items. Room and board costs are reimbursed only for PRTF settings.

"Skills restoration" means a face-to-face service to assist youth in the restoration of lost skills that are necessary to achieve the goals established in the youth's plan of care. Services include assisting the youth in restoring self-management, interpersonal, communication, and problem solving skills through modeling, coaching, and cueing.

"Therapeutic group home" means a congregate residential service providing 24-hour supervision in a community-based home having eight or fewer residents.

"Therapeutic pass" means time at home or time with family consisting of partial or entire days of time away from the therapeutic group home or psychiatric residential treatment facility as clinically indicated in the plan of care and as paired with facility-based and community-based interventions to promote discharge planning, community integration, and family engagement activities. Therapeutic passes are not recreational but are a therapeutic component of the plan of care and are designed for the direct benefit of the youth.

"Therapeutic services" means the structured therapeutic program designed to restore appropriate skills necessary to promote prosocial behavior and healthy living to include: the restoration of coping skills; family living and health awareness; interpersonal skills; communication skills; and stress management skills. Therapeutic services also engage families and reflect family-driven practices that correlate to sustained positive outcomes post-discharge for youth and their family members. Therapeutic services include assessment, individualized treatment planning, and interventions.

"Treatment planning" means development, implementing, monitoring, and updating of a person centered plan of care that is specific to the individual's unique treatment needs and acuity levels.

"Youth" means an individual younger than 21 years of age.

2. Therapeutic group home services pursuant to 42 CFR 440.130(d).

a. Therapeutic group home services for youth shall provide therapeutic services to restore or maintain appropriate skills necessary to promote prosocial behavior and healthy living, including skills restoration, family living and health awareness, interpersonal skills, communication skills, community integration skills, coping skills, and stress management skills. Therapeutic services shall also engage families and reflect family-driven practices that correlate to sustained positive outcomes post-discharge for youth and their family members. Therapeutic services may occur in group settings, in one-on-one interactions, or in the home setting during a therapeutic pass. Each component of therapeutic group home services is provided for the direct benefit of the youth, in accordance with the youth's needs and treatment goals identified in the youth's plan of care, and for the purpose of assisting in the youth's recovery. These services are provided under 42 CFR 440.130(d) in accordance with the rehabilitative services benefit.

b. Therapeutic group home services providers shall be licensed by the Department of Behavioral Health and Developmental Services under the Regulations for Children's Residential Facilities (12VAC35-36). Therapeutic group home services may only be rendered by and within the scope of practice of an LMHP, LMHP-supervisee, LMHP-resident, LMHP-RP, a QMHP-C, a QMHP-E, or a QPPMH as defined in 12VAC35-105-20, an ADL supervisor, or an ADL technician.

c. Medical necessity criteria for admission to a therapeutic group home. The following requirements for severity of need and intensity and quality of service shall be met to satisfy the medical necessity criteria for admission.

(1) Severity of need required for admission. All of the following criteria shall be met to satisfy the criteria for severity of need:

(a) The youth's behavioral health condition can only be safely and effectively treated in a 24-hour therapeutic milieu with onsite behavioral health therapy due to significant impairments in home, school, and community functioning caused by current mental health symptoms consistent with a DSM-5 diagnosis.

(b) The certificate of need must demonstrate all of the following: (i) ambulatory care resources (all available modalities of treatment less restrictive than inpatient treatment) available in the community do not meet the treatment needs of the youth; (ii) proper treatment of the youth's psychiatric condition requires services on an inpatient basis under the direction of a physician; and (iii) the services can reasonably be expected to improve the youth's condition or prevent further regression so that the services will no longer be needed.

(c) The state uniform assessment tool shall be completed. The assessment shall demonstrate at least two areas of moderate impairment in major life activities. A moderate impairment is defined as a major or persistent disruption in major life activities. A moderate impairment is evidenced by, but not limited to (i) frequent conflict in the family setting such as credible threats of physical harm, where "frequent" means more than expected for the youth's age and developmental level; (ii) frequent inability to accept age-appropriate direction and supervision from caretakers, from family members, at school, or in the home or community; (iii) severely limited involvement in social support, which means significant avoidance of appropriate social interaction, deterioration of existing relationships, or refusal to participate in therapeutic interventions; (iv) impaired ability to form a trusting relationship with at least one caretaker in the home, school, or community; (v) limited ability to consider the effect of one's inappropriate conduct on others; and (vi) interactions consistently involving conflict, which may include impulsive or abusive behaviors.

(d) Less restrictive community-based services have been given a fully adequate trial and were unsuccessful or, if not attempted, have been considered, but in either situation were determined to be unable to meet the youth's treatment needs and the reasons for that are discussed in the certificate of need.

(e) The youth's symptoms, or the need for treatment in a 24 hours a day, seven days a week level of care (LOC), are not primarily due to any of the following: (i) intellectual disability, developmental disability, or autistic spectrum disorder; (ii) organic mental disorders, traumatic brain injury, or other medical condition; or (iii) the youth does not require a more intensive level of care.

(f) The youth does not require primary medical or surgical treatment.

(2) Intensity and quality of service necessary for admission. All of the following criteria shall be met to satisfy the criteria for intensity and quality of service:

(a) The therapeutic group home service has been prescribed by a psychiatrist, psychologist, or other LMHP, LMHP-R, LMHP-RP, or LMHP-S who has documented that a residential setting is the least restrictive clinically appropriate service that can meet the specifically identified treatment needs of the youth.

(b) The therapeutic group home is not being used for clinically inappropriate reasons, including (i) an alternative to incarceration or preventative detention; (ii) an alternative to a parent's, guardian's, or agency's capacity to provide a place of residence for the youth; or (iii) a treatment intervention when other less restrictive alternatives are available.

(c) The youth's treatment goals are included in the plan of care and include behaviorally defined objectives that require and can reasonably be achieved within a therapeutic group home setting.

(d) The therapeutic group home is required to coordinate with the youth's community resources, including schools and FAPT as appropriate, with the goal of transitioning the youth out of the program to a less restrictive care setting for continued services as soon as possible and appropriate.

(e) The therapeutic group home program must incorporate nationally established, evidence-based, trauma-informed services and supports that promote recovery and resiliency.

(3) Continued stay criteria. The following criteria shall be met in order to satisfy the criteria for continued stay:

(a) All of the admission guidelines continue to be met and continue to be supported by the written clinical documentation.

(b) The youth shall meet one of the following criteria: (i) the desired outcome or level of functioning has not been restored or improved in the timeframe outlined in the youth's plan of care or the youth continues to be at risk for relapse based on history or (ii) the nature of the functional gains is tenuous and use of less intensive services will not achieve stabilization.

(c) The youth shall meet one of the following criteria: (i) the youth has achieved initial plan of care goals, but additional goals are indicated that cannot be met at a lower level of care; (ii) the youth is making satisfactory progress toward meeting goals but has not attained plan of care goals, and the goals cannot be addressed at a lower level of care; (iii) the youth is not making progress, and the plan of care has been modified to identify more effective interventions; or (iv) there are current indications that the youth requires this level of treatment to maintain level of functioning as evidenced by failure to achieve goals identified for therapeutic passes.

(d) There is a written, up-to-date discharge plan that (i) identifies the custodial parent or custodial caregiver at discharge; (ii) identifies the school the youth will attend at discharge, if applicable; (iii) includes individualized education program (IEP) and FAPT recommendations, if necessary; (iv) outlines the aftercare treatment plan (discharge to another residential level of care is not an acceptable discharge goal); and (v) lists barriers to community reintegration and progress made on resolving these barriers since last review.

(e) The active plan of care includes structure for daily therapeutic services and activities to ensure the attainment of therapeutic mental health goals as identified in the plan of care.

(f) There is evidence of intensive family or support system involvement occurring at least once per week, unless there is an identified or valid reason why it is not clinically appropriate or feasible.

(g) Less restrictive treatment options have been considered but cannot yet meet the youth's treatment needs. There is sufficient current clinical documentation or evidence to show that therapeutic group home level of care continues to be the least restrictive level of care that can meet the youth's mental health treatment needs.

(4) Discharge shall occur if any of the following applies: (i) the level of functioning has improved with respect to the goals outlined in the plan of care, and the youth can reasonably be expected to maintain these gains at a lower level of treatment; (ii) the youth no longer benefits from service as evidenced by absence of progress toward plan of care goals for a period of 60 days; or (iii) other less intensive services may achieve stabilization.

d. The following clinical activities shall be required for each therapeutic group home resident:

(1) An assessment shall be performed by an LMHP, LMHP-R, LMHP-RP, or LMHP-S.

(2) A face-to-face evaluation shall be performed by an LMHP, LMHP-R, LMHP-RP, or LMHP-S within 30 calendar days prior to admission with a documented DSM-5 or ICD-10 diagnosis.

(3) A certificate of need shall be completed by an independent certification team according to the requirements of subdivision D 4 of this section. Recertification shall occur at least every 60 calendar days by an LMHP, LMHP-R, LMHP-RP, or LMHP-S acting within his scope of practice.

(4) An IPOC that is specific to the youth's unique treatment needs and acuity levels. The IPOC shall be completed on the day of admission by an LMHP, LMHP-R, LMHP-RP, or LMHP-S and shall be signed by the LMHP, LMHP-R, LMHP-RP, or LMHP-S and the youth and a family member or legally authorized representative. The IPOC shall include all of the following:

(a) Youth and family strengths and personal traits that would facilitate recovery and opportunities to develop motivational strategies and treatment alliance;

(b) Diagnoses, symptoms, complaints, and complications indicating the need for admission;

(c) A description of the functional level of the youth;

(d) Treatment objectives with short-term and long-term goals;

(e) Orders for medications, psychiatric, medical, dental, and any special health care needs whether or not provided in the facilities, treatments, restorative and rehabilitative services, activities, therapies, therapeutic passes, social services, community integration, diet, and special procedures recommended for the health and safety of the youth;

(f) Plans for continuing care, including review and modification to the plan of care; and

(g) Plans for discharge.

(5) A CIPOC shall be completed no later than 14 calendar days after admission. The CIPOC shall meet all of the following criteria:

(a) Be based on a diagnostic evaluation that includes examination of the medical, psychological, social, behavioral, and developmental aspects of the youth's situation and shall reflect the need for therapeutic group home care;

(b) Be based on input from school, home, other health care providers, FAPT if necessary, the youth, and the family or legal guardian;

(c) Shall state treatment objectives that include measurable short-term and long-term goals and objectives, with target dates for achievement;

(d) Prescribe an integrated program of therapies, activities, and experiences designed to meet the treatment objectives related to the diagnosis; and

(e) Include a comprehensive discharge plan with clear action steps and target dates, including necessary, clinically appropriate community services to ensure continuity of care upon discharge with the youth's family, school, and community.

(6) The CIPOC shall be reviewed, signed, and dated every 30 calendar days by the LMHP, LMHP-R, LMHP-RP, or LMHP-S and the youth or a family member or primary caregiver. Updates shall be signed and dated by the LMHP, LMHP-R, LMHP-RP, or LMHP-S and the youth or a family member or legally authorized representative. The review shall include all of the following:

(a) The youth's response to the services provided;

(b) Recommended changes in the plan as indicated by the youth's overall response to the CIPOC interventions; and

(c) Determinations regarding whether the services being provided continue to be required.

(7) The plan of care shall include individualized activities, including a minimum of one intervention per 24-hour period in addition to individual, group, and family therapies. Daily interventions are not required when there is documentation to justify clinical or medical reasons for the youth's deviations from the plan of care. Interventions shall be documented on a progress note and shall be outlined in and aligned with the treatment goals and objectives in the IPOC and CIPOC. Any deviation from the plan of care shall be documented along with a clinical or medical justification for the deviation.

(8) Crisis management, clinical assessment, and individualized therapy shall be provided to address both mental health and substance use disorder needs as indicated in the plan of care to address intermittent crises and challenges within the therapeutic group home setting or community settings as defined in the plan of care and to avoid a higher level of care.

(9) Care coordination shall be provided with medical, educational, and other behavioral health providers and other entities involved in the care and discharge planning for the youth as included in the plan of care. Documentation of this care coordination shall be maintained by the facility or group home in the youth's record. The documentation shall include who was contacted, when the contact occurred, what information was transmitted, and recommended next steps.

(10) Weekly individual therapy shall be provided in the therapeutic group home, or other settings as appropriate for the youth's needs, by an LMHP, LMHP-R, LMHP-RP, or LMHP-S, which shall be documented in progress notes in accordance with the requirements for progress notes in 12VAC30-60-61 B.

(11) Group therapy shall be provided at a minimum of weekly and as documented in the plan of care by an LMHP, LMHP-R, LMHP-RP, or LMHP-S, and shall be documented in progress notes in accordance with the requirements for progress notes in 12VAC30-60-61 B.

(12) Family involvement begins immediately upon admission to the therapeutic group home. Family therapy shall be provided as clinically indicated and as documented in the plan of care and shall be provided by an LMHP, LMHP-R, LMHP-RP, or LMHP-S, and documented in progress notes in accordance with the requirements for progress notes in 12VAC30-60-61 B.

(13) Family engagement activities shall be provided in addition to family therapy. Family engagement activities shall be provided at least weekly as outlined in the plan of care, and daily communication with the family or legally authorized representative shall be part of the family engagement strategies in the plan of care. For each service authorization period when family engagement is not possible, the therapeutic group home shall identify and document the specific barriers to the youth's engagement with the youth's family or legally authorized representatives. The therapeutic group home shall document on a weekly basis the reasons why family engagement is not occurring as required. The therapeutic group home shall document alternative family engagement strategies to be used as part of the interventions in the plan of care and request approval of the revised plan of care by DMAS or its contractor. When family engagement is not possible, the therapeutic group home shall collaborate with DMAS or its contractor on a weekly basis to develop individualized family engagement strategies and document the revised strategies in the plan of care.

(14) Therapeutic passes shall be provided as clinically indicated in the plan of care and as paired with facility-based and community-based interventions to promote discharge planning, community integration, and family engagement activities.

(a) The provider shall document how the family was prepared for the therapeutic pass to include a review of the plan of care goals and objectives being addressed by the planned interventions and the safety and crisis plan in effect during the therapeutic pass.

(b) If a facility staff member does not accompany the youth on the therapeutic pass and the therapeutic pass exceeds 24 hours, the provider shall make daily contacts with the family and be available 24 hours per day to address concerns, incidents, or crises that may arise during the pass.

(c) Contact with the family shall occur within seven calendar days of the end date of the therapeutic pass to discuss the accomplishments and challenges of the therapeutic pass along with an update on progress toward plan of care goals and any necessary changes to the plan of care.

(d) Twenty-four therapeutic passes shall be permitted per youth, per admission, without authorization as approved by the treating LMHP, LMHP-R, LMHP-RP, and LMHP-S and documented in the plan of care. Additional therapeutic passes shall require service authorization. Any unauthorized therapeutic passes shall result in retraction for those days of service.

(15) Discharge planning shall begin at admission and continue throughout the youth's stay at the therapeutic group home. The family or guardian, the community services board (CSB), the family assessment and planning team (FAPT) case manager, and the DMAS contracted care manager shall be involved in treatment planning and shall identify the anticipated needs of the youth and family upon discharge and available services in the community. Prior to discharge, the therapeutic group home shall submit a comprehensive discharge plan to the DMAS contractor for review. Once the DMAS contractor approves the discharge plan, the provider shall begin actively collaborating with the family or legally authorized representative and the treatment team to identify behavioral health and medical providers and schedule appointments for a comprehensive needs assessment as needed. The therapeutic group home shall request information from post-discharge providers to establish that the planning of pending services and transition planning activities has begun, shall establish that the youth has been enrolled in school, and shall provide individualized education program recommendations to the school if necessary. The therapeutic group home shall inform the DMAS contractor of all scheduled appointments within 30 calendar days of discharge and shall notify the DMAS contractor within one business day of the youth's discharge date from the therapeutic group home.

(16) Failure to perform any of the items described in this subsection shall result in a retraction of the per diem for each day of noncompliance.

e. Service exclusions include the following:

(1) Room and board costs shall not be reimbursed. Facilities that only provide independent living services or nonclinical services that do not meet the requirements of this subsection are not eligible for reimbursement.

(2) Therapeutic group home services shall not be covered when treatment goals are met or other less intensive services may achieve stabilization.

(3) Services that are based upon incomplete, missing, or outdated service-specific provider intakes or plans of care shall be denied reimbursement.

3. PRTF services are a 24-hour, supervised, clinically and medically necessary out-of-home program designed to provide necessary support and address mental health, behavioral, substance use, cognitive, or other treatment needs of a youth in order to prevent or minimize the need for more intensive inpatient treatment. Active treatment and comprehensive discharge planning shall begin prior to admission. In order to be covered for youth, these services shall (i) meet DMAS-approved psychiatric medical necessity criteria or be approved as an EPSDT service based upon a diagnosis made by an LMHP, LMHP-R, LMHP-RP, or LMHP-S who is practicing within the scope of his license and (ii) be reflected in provider records and on the provider's claims for services by recognized diagnosis codes that support and are consistent with the requested professional services.

a. PRTF services shall be covered for the purpose of diagnosis and treatment of mental health and behavioral disorders when such services are rendered by a psychiatric facility that is not a hospital and is accredited by the Joint Commission on Accreditation of Healthcare Organizations, the Commission on Accreditation of Rehabilitation Facilities, the Council on Accreditation of Services for Families and Children, or by any other accrediting organization with comparable standards that is recognized by the state.

b. Providers of PRTF services shall be licensed by DBHDS.

c. PRTF services are reimbursable only when the treatment program is fully in compliance with (i) 42 CFR Part 441 Subpart D, specifically 42 CFR 441.151 (a) and (b) and 42 CFR 441.152 through 42 CFR 441.156 and (ii) the Conditions of Participation in 42 CFR Part 483 Subpart G. Each admission must be service authorized, and the treatment must meet DMAS requirements for clinical necessity.

d. The PRTF benefit for youth shall include services defined at 42 CFR 440.160 that are provided under the direction of a physician pursuant to a certification of medical necessity and plan of care developed by an interdisciplinary team of professionals and shall involve active treatment designed to achieve the youth's discharge from PRTF services at the earliest possible time.

e. PRTF services shall include assessment and reassessment; room and board; daily supervision; therapeutic services; individual, family, and group therapy; care coordination; interventions; general or special education; medical treatment, including medication, coordination of necessary medical services, and 24-hour onsite nursing availability; specialty services; and discharge planning that meets the medical and clinical needs of the youth.

f. Medical necessity criteria for admission to a PRTF. The following requirements for severity of need and intensity and quality of service shall be met to satisfy the medical necessity criteria for admission:

(1) Severity of need required for admission. The following criteria shall be met to satisfy the criteria for severity of need:

(a) There is clinical evidence that the youth has a DSM-5 disorder that is amenable to active psychiatric treatment.

(b) There is a high degree of potential of the condition leading to acute psychiatric hospitalization in the absence of residential treatment.

(c) Either (i) there is clinical evidence that the youth would be a risk to self or others if the youth were not in a PRTF or (ii) as a result of the youth's mental disorder, there is an inability for the youth to adequately care for his own physical needs, and caretakers, guardians, or family members are unable to safely fulfill these needs, representing potential serious harm to self.

(d) The youth requires supervision seven days per week, 24 hours per day to develop skills necessary for daily living; to assist with planning and arranging access to a range of educational, therapeutic, and aftercare services; and to develop the adaptive and functional behavior that will allow the youth to live outside of a PRTF setting.

(e) The youth's current living environment does not provide the support and access to therapeutic services needed.

(f) The youth is medically stable and does not require the 24-hour medical or nursing monitoring or procedures provided in a hospital level of care.

(2) Intensity and quality of service necessary for admission. The following criteria shall be met to satisfy the criteria for intensity and quality of service:

(a) The evaluation and assignment of a DSM-5 diagnosis must result from a face-to-face psychiatric evaluation.

(b) The program provides supervision seven days per week, 24 hours per day to assist with the development of skills necessary for daily living; to assist with planning and arranging access to a range of educational, therapeutic, and aftercare services; and to assist with the development of the adaptive and functional behavior that will allow the youth to live outside of a PRTF setting.

(c) An individualized plan of active psychiatric treatment and residential living support is provided in a timely manner. This treatment must be medically monitored, with 24-hour medical availability and 24-hour nursing services availability. This plan includes (i) at least once-a-week psychiatric reassessments; (ii) intensive family or support system involvement occurring at least once per week or valid reasons identified as to why such a plan is not clinically appropriate or feasible; (iii) psychotropic medications, when used, are to be used with specific target symptoms identified; (iv) evaluation for current medical problems; (v) evaluation for concomitant substance use issues; and (vi) linkage or coordination with the youth's community resources, including the local school division and FAPT case manager, as appropriate, with the goal of returning the youth to his regular social environment as soon as possible, unless contraindicated.

(3) Criteria for continued stay. The following criteria shall be met to satisfy the criteria for continued stay:

(a) Despite reasonable therapeutic efforts, clinical evidence indicates at least one of the following: (i) the persistence of problems that caused the admission to a degree that continues to meet the admission criteria (both severity of need and intensity of service needs); (ii) the emergence of additional problems that meet the admission criteria (both severity of need and intensity of service needs); or (iii) that disposition planning or attempts at therapeutic reentry into the community have resulted in or would result in exacerbation of the psychiatric illness to the degree that would necessitate continued PRTF treatment. Subjective opinions without objective clinical information or evidence are not sufficient to meet severity of need based on justifying the expectation that there would be a decompensation.

(b) There is evidence of objective, measurable, and time-limited therapeutic clinical goals that must be met before the youth can return to a new or previous living situation. There is evidence that attempts are being made to secure timely access to treatment resources and housing in anticipation of discharge, with alternative housing contingency plans also being addressed.

(c) There is evidence that the plan of care is focused on the alleviation of psychiatric symptoms and precipitating psychosocial stressors that are interfering with the youth's ability to return to a less-intensive level of care.

(d) The current or revised plan of care can be reasonably expected to bring about significant improvement in the problems meeting the criteria in subdivision 3 g (3) (a) of this subsection, and this is documented in weekly progress notes written and signed by the provider.

(e) There is evidence of intensive family or support system involvement occurring at least once per week, unless there is an identified valid reason why it is not clinically appropriate or feasible.

(f) A discharge plan is formulated that is directly linked to the behaviors or symptoms that resulted in admission and begins to identify appropriate post-PRTF resources including the local school division and FAPT case manager as appropriate.

(g) All applicable elements in admission-intensity and quality of service criteria are applied as related to assessment and treatment if clinically relevant and appropriate.

(4) Discharge criteria. Discharge shall occur if any of the following applies: (i) the level of functioning has improved with respect to the goals outlined in the plan of care, and the individual youth can reasonably be expected to maintain these gains at a lower level of treatment; (ii) the youth no longer benefits from service as evidenced by absence of progress toward plan of care goals for a period of 30 days; or (iii) other less intensive services may achieve stabilization.

g. The following clinical activities shall be required for each PRTF resident:

(1) A face-to-face assessment shall be performed by an LMHP, LMHP-R, LMHP-RS, or LMHP-S within 30 calendar days prior to admission and weekly thereafter and shall document a DSM-5 or ICD-10 diagnosis.

(2) A certificate of need shall be completed by an independent certification team according to the requirements of 12VAC30-50-130 D 4. Recertification shall occur at least every 30 calendar days by a physician acting within his scope of practice.

(3) The initial plan of care (IPOC) shall be completed within 24 hours of admission by the treatment team. The IPOC shall include:

(a) Individual and family strengths and personal traits that would facilitate recovery and opportunities to develop motivational strategies and treatment alliance;

(b) Diagnoses, symptoms, complaints, and complications indicating the need for admission;

(c) A description of the functional level of the youth;

(d) Treatment objectives with short-term and long-term goals;

(e) Any orders for medications, psychiatric, medical, dental, and any special health care needs, whether or not provided in the facility; education or special education; treatments; interventions; and restorative and rehabilitative services, activities, therapies, social services, diet, and special procedures recommended for the health and safety of the youth;

(f) Plans for continuing care, including review and modification to the plan of care;

(g) Plans for discharge; and

(h) Signature and date by the youth, parent, or legally authorized representative, a physician, and treatment team members.

(4) The CIPOC shall be completed and signed no later than 14 calendar days after admission by the treatment team. This information shall be used when considering changes and updating the CIPOC. The CIPOC shall meet all of the following criteria:

(a) Be based on a diagnostic evaluation that includes examination of the medical, psychological, social, behavioral, and developmental aspects of the youth's situation and must reflect the need for PRTF care;

(b) Be developed by an interdisciplinary team of physicians and other personnel specified in subdivision 3 h of this subsection who are employed by or provide services to the youth in the facility in consultation with the youth, family member, or legally authorized representative, or appropriate others into whose care the youth will be released after discharge;

(c) Shall state treatment objectives that shall include measurable, evidence-based, and short-term and long-term goals and objectives; family engagement activities; and the design of community-based aftercare with target dates for achievement;

(d) Prescribe an integrated program of therapies, interventions, activities, and experiences designed to meet the treatment objectives related to the youth and family treatment needs; and

(e) Describe comprehensive transition plans and coordination of current care and post-discharge plans with related community services to ensure continuity of care upon discharge with the youth's family, school, and community.

(5) The CIPOC shall be reviewed every 30 calendar days by the team specified in subdivision 3 h of this subsection to determine that services being provided are or were required from a PRTF and to recommend changes in the plan as indicated by the youth's overall adjustment during the time away from home. The CIPOC shall include the signature and date from the youth, parent, or legally authorized representative, a physician, and treatment team members.

(6) Individual therapy shall be provided a minimum of three times per week by an LMHP, LMHP-R, LMHP-RP, or LMHP-S and shall be documented in the plan of care and progress notes in accordance with the requirements in this subsection and the requirements for progress notes in 12VAC30-60-61 B.

(7) Group therapy shall be provided as clinically indicated by an LMHP, LMHP-R, LMHP-RP, or LMHP-S and shall be documented in the plan of care and progress notes in accordance with the requirements in this subsection and the requirements for progress notes in 12VAC30-60-61 B.

(8) Family therapy shall be provided as clinically indicated by an LMHP, LMHP-R, LMHP-RP, or LMHP-S and as documented in the plan of care and progress notes in accordance with the requirements in this subsection and requirements for progress notes in 12VAC30-60-61 B.

(9) Family engagement shall be provided in addition to family therapy or counseling. Family engagement shall be provided at least weekly as outlined in the plan of care and daily communication with the treatment team representative and the family or legally authorized representative shall be part of the family engagement strategies in the plan of care. For each service authorization period when family engagement is not possible, the PRTF shall identify and document the specific barriers to the youth's engagement with his family or legally authorized representatives. The PRTF shall document on a weekly basis the reasons that family engagement is not occurring as required. The PRTF shall document alternate family engagement strategies to be used as part of the interventions in the plan of care and request approval of the revised plan of care by DMAS. When family engagement is not possible, the PRTF shall collaborate with DMAS on a weekly basis to develop individualized family engagement strategies and document the revised strategies in the plan of care.

(10) Three non-psychotherapy interventions shall be provided per 24-hour period including nights and weekends. Family engagement activities are considered to be an intervention and shall occur based on the treatment and visitation goals and scheduling needs of the family or legally authorized representative. Interventions shall be documented on a progress note and shall be outlined in and aligned with the treatment goals and objectives in the plan of care. Any deviation from the plan of care shall be documented along with a clinical or medical justification for the deviation based on the needs of the youth.

(11) Therapeutic passes shall be provided as clinically indicated in the plan of care and as paired with community-based and facility-based interventions to promote discharge planning, community integration, and family engagement. Therapeutic passes include activities as listed in subdivision 2 d (13) of this section. Twenty-four therapeutic passes shall be permitted per youth, per admission, without authorization as approved by the treating physician and documented in the plan of care. Additional therapeutic passes shall require service authorization from DMAS or its contractor. Any unauthorized therapeutic passes not approved by the provider or DMAS or its contractor shall result in retraction for those days of service.

(12) Discharge planning shall begin at admission and continue throughout the youth's placement at the PRTF. The parent or legally authorized representative, the community services board (CSB), the family assessment planning team (FAPT) case manager, if appropriate, and the DMAS contracted care manager shall be involved in treatment planning and shall identify the anticipated needs of the youth and family upon discharge and identify the available services in the community. Prior to discharge, the PRTF shall submit a comprehensive discharge plan to the DMAS contractor for review. Once the DMAS contractor approves the discharge plan, the provider shall begin collaborating with the parent or legally authorized representative and the treatment team to identify behavioral health and medical providers and schedule appointments for comprehensive needs assessments as needed. The PRTF shall request information from post-discharge providers to establish that the planning of services and activities has begun, shall establish that the youth has been enrolled in school, and shall provide individualized education program recommendations to the school if necessary. The PRTF shall inform the DMAS contractor of all scheduled appointments within 30 calendar days of discharge and shall notify the DMAS contractor within one business day of the youth's discharge date from the PRTF.

(13) A urine drug screen is considered at the time of admission, when progress is not occurring, when substance misuse is suspected, or when substance use and medications may have a potential adverse interaction. After a positive screen, additional random screens are considered and referral to a substance use disorder provider is considered.

(14) Failure to perform any of the items as described in subdivisions 3 g (1) through 3 g (13) of this subsection up until the discharge of the youth shall result in a retraction of the per diem and all other contracted and coordinated service payments for each day of noncompliance.

h. The team developing the CIPOC shall meet the following requirements:

(1) At least one member of the team must have expertise in pediatric behavioral health. Based on education and experience, preferably including competence in child and adolescent psychiatry, the team must be capable of all of the following: assessing the youth's immediate and long-range therapeutic needs, developmental priorities, and personal strengths and liabilities; assessing the potential resources of the youth's family or legally authorized representative; setting treatment objectives; and prescribing therapeutic modalities to achieve the CIPOC's objectives.

(2) The team shall include one of the following:

(a) A board-eligible or board-certified psychiatrist;

(b) A licensed clinical psychologist and a physician licensed to practice medicine or osteopathy; or

(c) A physician licensed to practice medicine or osteopathy with specialized training and experience in the diagnosis and treatment of mental diseases and a licensed clinical psychologist.

(3) The team shall also include one of the following: an LMHP, LMHP-supervisee, LMHP-resident, or LMHP-RP.

4. Requirements for independent certification teams applicable to both therapeutic group homes and PRTFs:

a. The independent certification team shall certify the need for PRTF or therapeutic group home services and issue a certificate of need document within the process and timeliness standards as approved by DMAS under contractual agreement with the DMAS contractor.

b. The independent certification team shall be approved by DMAS through a memorandum of understanding with a locality or be approved under contractual agreement with the DMAS contractor. The team shall initiate and coordinate referral to the family assessment and planning team (FAPT) as defined in §§ 2.2-5207 and 2.2-5208 of the Code of Virginia to facilitate care coordination and for consideration of educational coverage and other supports not covered by DMAS.

c. The independent certification team shall assess the youth's and family's strengths and needs in addition to diagnoses, behaviors, and symptoms that indicate the need for behavioral health treatment and also consider whether local resources and community-based care are sufficient to meet the youth's treatment needs, as presented within the previous 30 calendar days, within the least restrictive environment.

d. The LMHP, LMHP-supervisee, LMHP-resident, or LMHP-RP, as part of the independent certification team, shall meet with the youth and the youth's parent or legally authorized representative within two business days from a request to assess the youth's needs and begin the process to certify the need for an out-of-home placement.

e. The independent certification team shall meet with the youth and the youth's parent or legally authorized representative within 10 business days from a request to certify the need for an out-of-home placement.

f. The independent certification team shall assess the treatment needs of the youth to issue a certificate of need (CON) for the most appropriate medically necessary services. The certification shall include the dated signature and credentials for each of the team members who rendered the certification.

g. The CON shall be effective for 30 calendar days prior to admission.

h. The independent certification team shall provide the completed CON to the facility within one calendar day of completing the CON.

i. The youth and the youth's parent or legally authorized representative shall have the right to freedom of choice of service providers.

j. If the youth or the youth's parent or legally authorized representative disagrees with the independent certification team's recommendation, the parent or legally authorized representative may appeal the recommendation in accordance with 12VAC30-110.

k. If the LMHP, LMHP-R, LMHP-RP, or LMHP-S, as part of the independent certification team, determines that the youth is in immediate need of treatment, the LMHP, LMHP-R, LMHP-RP, or LMHP-S shall refer the youth to an appropriate Medicaid-enrolled crisis intervention provider, crisis stabilization provider, or inpatient psychiatric provider in accordance with 12VAC30-50-226 or shall refer the youth for emergency admission to a PRTF or therapeutic group home under subdivision 4 m of this subsection and shall also alert the youth's managed care organization.

l. For youth who are already eligible for Medicaid at the time of admission, the independent certification team shall be a DMAS-authorized contractor with competence in the diagnosis and treatment of mental illness, preferably in child and adolescent psychiatry, and have knowledge of the youth's situation and service availability in the youth's local service area. The team shall be composed of at least one physician and one LMHP, including LMHP-S, LMHP-R, or LMHP-RP. The youth's parent or legally authorized representative shall be included in the certification process.

m. For emergency admissions, an assessment must be made by the team responsible for the comprehensive individual plan of care (CIPOC). Reimbursement shall only occur when a certificate of need is issued by the team responsible for the CIPOC within 14 calendar days after admission. The certification shall cover any period of time after admission and before claims are made for reimbursement by Medicaid. After processing an emergency admission, the therapeutic group home, PRTF, or institution for mental diseases (IMD) shall notify the DMAS contractor within five calendar days of the youth's status as being under the care of the facility.

n. For youth who apply and become eligible for Medicaid while an inpatient in the facility or program, the certification shall be made by the team responsible for the CIPOC and shall cover any period of time before the application for Medicaid eligibility for which claims are made for reimbursement by Medicaid. Upon the youth's enrollment into the Medicaid program, the therapeutic group home, PRTF, or IMD shall notify the DMAS contractor of the youth's status as being under the care of the facility within five calendar days of the youth becoming eligible for Medicaid benefits.

5. Service authorization requirements applicable to both therapeutic group homes and PRTFs:

a. Authorization shall be required and shall be conducted by DMAS or its contractor using medical necessity criteria specified in this subsection.

b. The youth shall have a valid psychiatric diagnosis and meet the medical necessity criteria as defined in this subsection to satisfy the criteria for admission. The diagnosis shall be current, as documented within the past 12 months. If a current diagnosis is not available, the youth will require a mental health evaluation prior to admission by an LMHP, LMHP-R, LMHP-RP, or LMHP-S affiliated with the independent certification team to establish a diagnosis and recommend and coordinate referral to the available treatment options.

c. At authorization, an initial length of stay shall be agreed upon by the youth and parent or legally authorized representative with the treating provider, and the treating provider shall be responsible for evaluating and documenting evidence of treatment progress, assessing the need for ongoing out-of-home placement, and obtaining authorization for continued stay.

d. Information that is required to obtain authorization for these services shall include:

(1) A completed state-designated uniform assessment instrument approved by DMAS completed no more than 30 calendar days prior to the date of submission;

(2) A certificate of need completed by an independent certification team specifying all of the following:

(a) The ambulatory care and Medicaid or FAPT-funded services available in the community do not meet the specific treatment needs of the youth;

(b) Alternative community-based care was not successful;

(c) Proper treatment of the youth's psychiatric condition requires services in a 24-hour supervised setting under the direction of a physician; and

(d) The services can reasonably be expected to improve the youth's condition or prevent further regression so that a more intensive level of care will not be needed;

(3) Diagnosis as defined in the DSM-5 and based on (i) an evaluation by a psychiatrist or LMHP, LMHP-R, LMHP-RP, or LMHP-S that has been completed within 30 calendar days of admission or (ii) a diagnosis confirmed in writing by an LMHP, LMHP-R, LMHP-RP, or LMHP-S after review of a previous evaluation completed within one year of admission;

(4) A description of the youth's behavior during the seven calendar days immediately prior to admission;

(5) A description of alternate placements and community mental health and rehabilitation services and traditional behavioral health services pursued and attempted and the outcomes of each service;

(6) The youth's level of functioning and clinical stability;

(7) The level of family involvement and supports available; and

(8) The initial plan of care (IPOC).

6. Continued stay criteria requirements applicable to both therapeutic group homes and PRTFs. For a continued stay authorization or a reauthorization to occur, the youth shall meet the medical necessity criteria as defined in this subsection to satisfy the criteria for continuing care. The length of the authorized stay shall be determined by DMAS or its contractor. A current plan of care and a current (within 30 calendar days) summary of progress related to the goals and objectives of the plan of care shall be submitted to DMAS or its contractor for continuation of the service. The service provider shall also submit:

a. A state uniform assessment instrument if updated since the last service authorization request;

b. Documentation that the required services have been provided as defined in the plan of care;

c. Current (within the last 14 calendar days) information on progress related to the achievement of all treatment and discharge-related goals; and

d. A description of the youth's continued impairment and treatment needs, problem behaviors, family engagement activities, community-based discharge planning and care coordination, and need for a residential level of care.

7. EPSDT services requirements applicable to therapeutic group homes and PRTFs. Service limits may be exceeded based on medical necessity for youth eligible for EPSDT. EPSDT services may involve service modalities not available to other individuals, such as applied behavioral analysis and neuro-rehabilitative services. Individualized services to address specific clinical needs identified in an EPSDT screening shall require authorization by a DMAS contractor. In unique EPSDT cases, DMAS or its contractor may authorize specialized services beyond the standard therapeutic group home or PRTF medical necessity criteria and program requirements, as medically and clinically indicated to ensure the most appropriate treatment is available to each youth. Treating service providers authorized to deliver medically necessary EPSDT services in therapeutic group homes and PRTFs on behalf of a Medicaid-enrolled youth shall adhere to the individualized interventions and evidence-based progress measurement criteria described in the plan of care and approved for reimbursement by DMAS or its contractor. All documentation, independent certification team, family engagement activity, therapeutic pass, and discharge planning requirements shall apply to cases approved as EPSDT PRTF or therapeutic group home service.

8. Inpatient psychiatric services shall be covered for youth for medically necessary stays in inpatient psychiatric facilities described in 42 CFR 440.160(b)(1) and (b)(2) for the purpose of diagnosis and treatment of mental health and behavioral disorders identified under EPSDT when such services meet the requirements set forth in subdivision 7 of this subsection.

a. Inpatient psychiatric services shall be provided under the direction of a physician.

b. Inpatient psychiatric services shall be provided by (i) a psychiatric hospital that undergoes a state survey to determine whether the hospital meets the requirements for participation in Medicare as a psychiatric hospital as specified in 42 CFR 482.60 or is accredited by a national organization whose psychiatric hospital accrediting program has been approved by the Centers for Medicare and Medicaid Services (CMS); or (ii) a hospital with an inpatient psychiatric program that undergoes a state survey to determine whether the hospital meets the requirements for participation in Medicare as a hospital, as specified in 42 CFR part 482 or is accredited by a national accrediting organization whose hospital accrediting program has been approved by CMS.

c. Inpatient psychiatric admissions at general acute care hospitals and freestanding psychiatric hospitals shall also be subject to the requirements of 12VAC30-50-100, 12VAC30-50-105, and 12VAC30-60-25.

d. PRTF services are reimbursable only when the treatment program is fully in compliance with (i) 42 CFR Part 441 Subpart D, specifically 42 CFR 441.151(a) and 42 CFR 441.151 (b) and 42 CFR 441.152 through 42 CFR 441.156 and (ii) the Conditions of Participation in 42 CFR Part 483 Subpart G. Each admission must be service authorized and the treatment must meet DMAS requirements for clinical necessity.

e. The inpatient psychiatric benefit for youth shall include services that are provided pursuant to a certification of medical necessity and plan of care developed by an interdisciplinary team of professionals and shall involve active treatment designed to achieve the youth's discharge from inpatient status at the earliest possible time.

E. Mental health family support partners.

1. Mental health family support partners are peer recovery support services and are nonclinical, peer-to-peer activities that engage, educate, and support the caregiver and the youth's self-help efforts to improve health recovery resiliency and wellness. Mental health family support partners is a peer support service and is a strength-based, individualized service provided to the caregiver of a Medicaid-eligible youth (defined as an individual younger than 21 years of age) with a mental health disorder that is the focus of support. The services provided to the caregiver and youth must be directed exclusively toward the benefit of the Medicaid-eligible youth. Services are expected to improve outcomes for youth with complex needs who are involved with multiple systems and increase the youth's and family's confidence and capacity to manage their own services and supports while promoting recovery and healthy relationships. These services are rendered by a PRS who is (i) a parent of a youth with a similar mental health disorder or (ii) an adult with personal experience with a family member with a similar mental health disorder with experience navigating behavioral health care services. The PRS shall perform the service within the scope of his knowledge, lived experience, and education.

2. Under the clinical oversight of the LMHP, LMHP-R, LMHP-RP, or LMHP-S making the recommendation for mental health family support partners, the peer recovery specialist in consultation with his direct supervisor shall develop a recovery, resiliency, and wellness plan based on the assessment of the LMHP, LMHP-R, LMHP-RP, or LMHP-S for service, the youth's and the caregiver's perceived recovery needs, and any clinical assessments or comprehensive needs assessments as defined in subsection C of this section within 30 calendar days of the initiation of service. Development of the recovery, resiliency, and wellness plan shall include collaboration with the youth and the youth's caregiver. Individualized goals and strategies shall be focused on the youth's identified needs for self-advocacy and recovery. The recovery, resiliency, and wellness plan shall also include documentation of how many days per week and how many hours per week are required to carry out the services in order to meet the goals of the plan. The recovery, resiliency, and wellness plan shall be completed, signed, and dated by (i) the LMHP, LMHP-R, LMHP-RP, or LMHP-S; (ii) the PRS; (iii) the direct supervisor; (iv) the youth; and (v) the youth's caregiver within 30 calendar days of the initiation of service. The PRS shall act as an advocate for the youth, encouraging the youth and the caregiver to take a proactive role in developing and updating goals and objectives in the individualized recovery planning.

3. Documentation of required activities shall be required as set forth in 12VAC30-130-5200 C and E through J.

4. Limitations and exclusions to service delivery shall be the same as set forth in 12VAC30-130-5210.

5. Caregivers of youth who qualify to receive mental health family support partners shall (i) care for a youth with a mental health disorder who requires recovery assistance and (ii) meet two or more of the following:

a. The youth and his caregiver need peer-based recovery-oriented services for the maintenance of wellness and the acquisition of skills needed to support the youth.

b. The youth and his caregiver need assistance to develop self-advocacy skills to assist the youth in achieving self-management of the youth's health status.

c. The youth and his caregiver need assistance and support to prepare the youth for a successful work or school experience.

d. The youth and his caregiver need assistance to help the youth and caregiver assume responsibility for recovery.

6. Youth who are 18, 19, and 20 years of age who meet the medical necessity criteria in 12VAC30-50-226 B 7 e, who would benefit from receiving peer supports directly and who choose to receive mental health peer support services directly instead of through their caregiver, shall be permitted to receive mental health peer support services by an appropriate PRS.

7. To qualify for continued mental health family support partners, medical necessity criteria shall continue to be met, and progress notes shall document the status of progress relative to the goals identified in the recovery, resiliency, and wellness plan.

8. Discharge criteria from mental health family support partners shall be the same as set forth in 12VAC30-130-5180 E.

9. Mental health family support partners services shall be rendered on an individual basis or in a group.

10. Prior to service initiation, an assessment shall be conducted and documented by an LMHP, LMHP-R, LMHP-RP, or LMHP-S who is acting within his scope of practice under state law. The assessment shall verify that the youth meets the medical necessity criteria set forth in subdivision 5 of this subsection. The assessment shall be included as part of the recovery, resiliency, and wellness plan and medical record. Services shall be initiated within 30 calendar days from when the assessment was complete.

11. Effective July 1, 2017, a peer recovery specialist shall have the qualifications, education, experience, and certification required by DBHDS in accordance with 12VAC35-250. Peer recovery specialists shall be registered by the Virginia Board of Counseling. The PRS shall perform mental health family support partners services under the oversight of the LMHP, LMHP-R, LMHP-RP, or LMHP-S who shall provide the clinical oversight of the recovery, resiliency, and wellness plan.

12. The PRS shall be employed by or have a contractual relationship with the enrolled provider licensed for one of the following:

a. Acute care general and emergency department hospital services licensed by the Department of Health.

b. Freestanding psychiatric hospital and inpatient psychiatric unit licensed by the Department of Behavioral Health and Developmental Services.

c. Psychiatric residential treatment facility licensed by the Department of Behavioral Health and Developmental Services.

d. Therapeutic group home licensed by the Department of Behavioral Health and Developmental Services.

e. Outpatient mental health clinic services licensed by the Department of Behavioral Health and Developmental Services.

f. Outpatient psychiatric services provider.

g. A community mental health and rehabilitative services provider licensed by the Department of Behavioral Health and Developmental Services as a provider of one of the following community mental health and rehabilitative services as defined in this section, 12VAC30-50-226, 12VAC30-50-420, or 12VAC30-50-430 for which the youth meets medical necessity criteria: (i) intensive in home; (ii) therapeutic day treatment; (iii) day treatment or partial hospitalization; (iv) crisis intervention; (v) crisis stabilization; (vi) mental health skill building; or (vii) mental health case management.

13. Only the licensed and enrolled provider as referenced in subdivision 12 of this subsection shall be eligible to bill and receive reimbursement from DMAS or its contractor for mental health family support partner services. Payments shall not be permitted to providers that fail to enter into an enrollment agreement with DMAS or its contractor. Reimbursement shall be subject to retraction for any billed service that is determined not to be in compliance with DMAS requirements.

14. Supervision of the PRS shall meet the requirements set forth in 12VAC30-50-226 B 7 l and m.

F. Hearing aids shall be reimbursed for individuals younger than 21 years of age according to medical necessity when provided by practitioners licensed to engage in the practice of fitting or dealing in hearing aids under the Code of Virginia.

G. Addiction and recovery treatment services shall be covered under EPSDT consistent with 12VAC30-130-5000 et seq.

H. Services facilitators shall be required for all consumer-directed personal care services consistent with the requirements set out in 12VAC30-120-935.

I. Behavioral therapy services shall be covered for individuals younger than 21 years of age.

1. Definitions. The following words and terms when used in this subsection shall have the following meanings unless the context clearly indicates otherwise:

"Behavioral therapy" means systematic interventions provided by licensed practitioners acting within the scope of practice defined under a Virginia Department of Health Professions regulatory board and covered as remedial care under 42 CFR 440.130(d) to youth. Behavioral therapy includes applied behavioral analysis. Family training related to the implementation of the behavioral therapy shall be included as part of the behavioral therapy service. Behavioral therapy services shall be subject to clinical reviews and determined as medically necessary. Behavioral therapy may be provided in the youth's home and community settings as deemed by DMAS or its contractor as medically necessary treatment.

"Counseling" means a professional mental health service that can only be provided by a person holding a license issued by a health regulatory board at the Department of Health Professions, which includes conducting assessments, making diagnoses of mental disorders and conditions, establishing treatment plans, and determining treatment interventions.

"Primary care provider" means a licensed medical practitioner who provides preventive and primary health care and is responsible for providing routine EPSDT screening and referral and coordination of other medical services needed by the individual.

"Youth" means an individual younger than 21 years of age who is receiving behavioral therapy services.

2. Behavioral therapy services shall be designed to enhance communication skills and decrease maladaptive patterns of behavior, which if left untreated, could lead to more complex problems and the need for a greater or a more intensive level of care. The service goal shall be to ensure the youth's family or caregiver is trained to effectively manage the youth's behavior in the home using modification strategies. All services shall be provided in accordance with the ISP and clinical assessment summary.

3. Behavioral therapy services shall be covered when recommended by the youth's primary care provider or other licensed physician, licensed physician assistant, or licensed nurse practitioner and determined by DMAS or its contractor to be medically necessary to correct or ameliorate significant impairments in major life activities that have resulted from either developmental, behavioral, or mental disabilities. Criteria for medical necessity are set out in 12VAC30-60-61 F. A behavioral therapy assessment shall be required prior to these services in order to receive authorization for reimbursement. Individual service plans (ISPs) shall be required throughout the entire duration of services. The services shall be provided in accordance with the individual service plan and clinical assessment summary. These services shall be provided in settings that are natural or normal for a youth without a disability, such as the youth's home, unless there is justification in the ISP, which has been authorized for reimbursement, to include service settings that promote a generalization of behaviors across different settings to maintain the targeted functioning outside of the treatment setting in the youth's home and the larger community within which the youth resides. Covered behavioral therapy services shall include:

a. Initial and periodic behavioral therapy assessment as defined in 12VAC30-60-61 F;

b. Development of initial and updated ISPs as established in 12VAC30-60-61 F;

c. Clinical supervision activities. Requirements for clinical supervision are set out in 12VAC30-60-61 F;

d. Behavioral training to increase the youth's adaptive functioning and communication skills;

e. Training a family member in behavioral modification methods as established in 12VAC30-60-61 F;

f. Documentation and analysis of quantifiable behavioral data related to the treatment objectives; and

g. Care coordination.

4. All personal care services rendered to children under the authority of 42 CFR 440.40(b) shall comply with the requirements of 12VAC30-60-65 with regard to electronic visit verification.

J. School health services.

1. School health assistant services are repealed effective July 1, 2006.

2. School divisions may provide routine well-child screening services under the State Plan. Diagnostic and treatment services that are otherwise covered under early and periodic screening, diagnosis and treatment services, shall not be covered for school divisions. School divisions to receive reimbursement for the screenings shall be enrolled with DMAS as clinic providers.

a. Youth enrolled in managed care organizations shall receive screenings from those organizations. School divisions shall not receive reimbursement for screenings from DMAS for these individuals.

b. School-based services are listed in a recipient's individualized education program (IEP) and covered under one or more of the service categories described in § 1905(a) of the Social Security Act. These services are necessary to correct or ameliorate defects of physical or mental illnesses or conditions.

3. Providers shall be licensed under the applicable state practice act or comparable licensing criteria by the Virginia Department of Education, and shall meet applicable qualifications under 42 CFR Part 440. Identification of defects, illnesses or conditions and services necessary to correct or ameliorate them shall be performed by practitioners qualified to make those determinations within their licensed scope of practice, either as a member of the IEP team or by a qualified practitioner outside the IEP team.

a. Providers shall be employed by the school division or under contract to the school division.

b. Supervision of services by providers recognized in subdivision 4 of this subsection shall occur as allowed under federal regulations and consistent with Virginia law, regulations, and DMAS provider manuals.

c. The services described in subdivision 4 of this subsection shall be delivered by school providers, but may also be available in the community from other providers.

d. Services in this subsection are subject to utilization control as provided under 42 CFR Parts 455 and 456.

e. The IEP shall determine whether or not the services described in subdivision 4 of this subsection are medically necessary and that the treatment prescribed is in accordance with standards of medical practice. Medical necessity is defined as services ordered by IEP providers. The IEP providers are qualified Medicaid providers to make the medical necessity determination in accordance with their scope of practice. The services must be described as to the amount, duration and scope.

4. Covered services include:

a. Physical therapy and occupational therapy and services for individuals with speech, hearing, and language disorders, performed by, or under the direction of, providers who meet the qualifications set forth at 42 CFR 440.110. This coverage includes audiology services.

b. Skilled nursing services are covered under 42 CFR 440.60. These services are to be rendered in accordance to the licensing standards and criteria of the Virginia Board of Nursing. Nursing services are to be provided by licensed registered nurses or licensed practical nurses but may be delegated by licensed registered nurses in accordance with the regulations of the Virginia Board of Nursing, especially the section on delegation of nursing tasks and procedures. The licensed practical nurse is under the supervision of a registered nurse.

(1) The coverage of skilled nursing services shall be of a level of complexity and sophistication (based on assessment, planning, implementation, and evaluation) that is consistent with skilled nursing services when performed by a licensed registered nurse or a licensed practical nurse. These skilled nursing services shall include dressing changes, maintaining patent airways, medication administration or monitoring, and urinary catheterizations.

(2) Skilled nursing services shall be directly and specifically related to an active, written plan of care developed by a registered nurse that is based on a written order from a physician, physician assistant, or nurse practitioner for skilled nursing services. This order shall be recertified on an annual basis.

c. Psychiatric and psychological services performed by licensed practitioners within the scope of practice are defined under state law or regulations and covered as physicians' services under 42 CFR 440.50 or medical or other remedial care under 42 CFR 440.60. These outpatient services include individual medical psychotherapy, group medical psychotherapy coverage, and family medical psychotherapy. Psychological and neuropsychological testing are allowed when done for purposes other than educational diagnosis, school admission, evaluation of an individual with intellectual or developmental disability prior to admission to a nursing facility, or any placement issue. These services are covered in the nonschool settings also. School providers who may render these services when licensed by the state include psychiatrists, licensed clinical psychologists, school psychologists, licensed clinical social workers, professional counselors, psychiatric clinical nurse specialists, marriage and family therapists, and school social workers.

d. Personal care services are covered under 42 CFR 440.167 and performed by persons qualified under this subsection. The personal care assistant is supervised by a DMAS recognized school-based health professional who is acting within the scope of licensure. This professional develops a written plan for meeting the needs of the individual, which is implemented by the assistant. The assistant must have qualifications comparable to those for other personal care aides recognized by the Virginia Department of Medical Assistance Services. The assistant performs services such as assisting with toileting, ambulation, and eating. The assistant may serve as an aide on a specially adapted school vehicle that enables transportation to or from the school or school contracted provider on days when the student is receiving a Medicaid-covered service under the IEP. Individuals requiring an aide during transportation on a specially adapted vehicle shall have this stated in the IEP.

e. Medical evaluation services are covered as physicians' services under 42 CFR 440.50 or as medical or other remedial care under 42 CFR 440.60. Persons performing these services shall be licensed physicians, physician assistants, or nurse practitioners. These practitioners shall identify the nature or extent of an individual's medical or other health related condition.

f. Transportation is covered as allowed under 42 CFR 431.53 and described at State Plan Attachment 3.1-D (12VAC30-50-530). Transportation shall be rendered only by school division personnel or contractors. Transportation is covered for an individual who requires transportation on a specially adapted school vehicle that enables transportation to or from the school or school- contracted provider on days when the individual is receiving a Medicaid-covered service under the IEP. Transportation shall be listed in the individual's IEP. Individuals requiring an aide during transportation on a specially adapted vehicle shall have this stated in the IEP.

g. Assessments are covered as necessary to assess or reassess the need for medical services in an individual's IEP and shall be performed by any of the above licensed practitioners within the scope of practice. Assessments and reassessments not tied to medical needs of the individual shall not be covered.

5. DMAS will ensure through quality management review that duplication of services will be monitored. School divisions have a responsibility to ensure that if an individual is receiving additional therapy outside of the school, that there will be coordination of services to avoid duplication of service.

K. Family planning services and supplies for individuals of child-bearing age.

1. Service must be ordered or prescribed and directed or performed within the scope of the license of a practitioner of the healing arts.

2. Family planning services shall be defined as those services that delay or prevent pregnancy. Coverage of such services shall not include services to treat infertility or services to promote fertility. Family planning services shall not cover payment for abortion services and no funds shall be used to perform, assist, encourage, or make direct referrals for abortions.

3. Family planning services as established by § 1905(a)(4)(C) of the Social Security Act include annual family planning exams; cervical cancer screening for women; sexually transmitted infection (STI) testing; lab services for family planning and STI testing; family planning education, counseling, and preconception health; sterilization procedures; nonemergency transportation to a family planning service; and U.S. Food and Drug Administration approved prescription and over-the-counter contraceptives, subject to limits in 12VAC30-50-210.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia, 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-03-3.1100 § 4, eff. April 1, 1993; amended, eff. June 30, 1993; Virginia Register Volume 10, Issue 22, eff. September 1, 1994; Volume 14, Issue 7, eff. January 22, 1998; Volume 17, Issue 5, eff. January 1, 2001; Volume 20, Issue 7, eff. February 1, 2004; Volume 22, Issue 8, eff. January 25, 2006; Volume 23, Issue 21, eff. January 1, 2008; Volume 25, Issue 5, eff. December 10, 2008; Volume 26, Issue 11, eff. March 3, 2010; Volume 31, Issue 9, eff. January 30, 2015; Volume 33, Issue 11, eff. February 22, 2017; Volume 33, Issue 12, eff. March 8, 2017; Volume 33, Issue 12, eff. April 1, 2017; Volume 34, Issue 3, eff. November 16, 2017; Volume 35, Issue 2, eff. October 27, 2018; Volume 35, Issue 6, eff. December 12, 2018; Volume 35, Issue 10, eff. February 21, 2019; Volume 35, Issue 24, eff. August 22, 2019; Volume 37, Issue 14, eff. April 14, 2021; Volume 37, Issue 24, eff. August 18, 2021; Volume 38, Issue 12, eff. March 17, 2022.

12VAC30-50-131 Services provided by certified Early Intervention practitioners under EPSDT

A. Definitions. The following words and terms when used in these regulations shall have the following meanings unless the context clearly indicates otherwise:

"DBHDS" means the Department of Behavioral Health and Developmental Services, the lead state agency for Early Intervention services appointed by the Governor in accordance with Chapter 53 (§ 2.2-5300 et seq.) of Title 2.2 of the Code of Virginia.

"Early Intervention services" or "EI" means services provided through Part C of the Individuals with Disabilities Education Act (20 USC § 1431 et seq.), as amended. Early Intervention services are specialized rehabilitative services covered in accordance with 42 CFR 440.130(d), which are designed to meet the developmental needs of each child and the needs of the family related to enhancing the child's development, and are provided to children from birth to age three who have (i) a 25% developmental delay in one or more areas of development, (ii) atypical development, or (iii) a diagnosed physical or mental condition that has a high probability of resulting in a developmental delay.

"Individualized family service plan" or "IFSP" means a comprehensive and regularly updated statement specific to the child being treated containing, but not necessarily limited to, treatment or training needs, measurable outcomes expected to be achieved, services to be provided with the recommended frequency to achieve the outcomes, and estimated timetable for achieving the outcomes. The IFSP is developed by a multidisciplinary team that includes the family, under the auspices of the local lead agency.

"Local lead agency" means an agency under contract with the Department of Behavioral Health and Developmental Services to facilitate implementation of a local Early Intervention system as described in Chapter 53 (§ 2.2-5300 et seq.) of Title 2.2 of the Code of Virginia.

"Primary care provider" means a practitioner who provides preventive and primary health care and is responsible for providing routine Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) screening and referral and coordination of other medical services needed by the child.

B. Coverage for Early Intervention services.

1. Early Intervention services shall be reimbursed for individuals younger than 21 years of age who meet criteria for Early Intervention services established by DBHDS in accordance with Chapter 53 (§ 2.2-5300 et seq.) of Title 2.2 of the Code of Virginia.

2. Early Intervention services shall be recommended by the child's primary care provider or other qualified EPSDT screening provider as necessary to correct or ameliorate a physical or mental condition.

3. Early Intervention services shall be provided in settings that are natural or normal for an infant or toddler without a disability, such as the home, unless there is justification for an atypical location.

4. Except for the initial and periodic assessments, Early Intervention services shall be described in an IFSP developed by the local lead agency and designed to prevent or ameliorate developmental delay within the context of the Early Intervention services system defined by Chapter 53 (§ 2.2-5300 et seq.) of Title 2.2 of the Code of Virginia.

5. Medical necessity for Early Intervention services shall be defined by the IFSP. The IFSP shall describe service needs in terms of amount, duration, and scope. The IFSP shall be approved by the child's primary care provider.

6. Covered Early Intervention services include the following functions provided with the infant or toddler and the child's parent or other authorized caregiver by a certified Early Intervention professional:

a. Assessment, including consultation with the child's family and other service providers, to evaluate:

(1) The child's level of functioning in the following developmental areas: cognitive development; physical development, including vision and hearing; communication development; social or emotional development; and adaptive development;

(2) The family's capacity to meet the developmental needs of the child; and

(3) Services needed to correct or ameliorate developmental conditions during the infant and toddler years. EI services include, but are not limited to, PT, OT, and speech therapy as described in 42 CFR 440.110, and developmental/rehabilitative services as described in 42 CFR 440.130(d). All licensed PT, OT, and speech therapy providers shall comply with requirements of 42 CFR 440.110. All EI providers are certified to provide EI services by the Virginia Department of Behavioral Health and Developmental Services.

b. Participation in a multidisciplinary team review of assessments to develop integrated, measurable outcomes for the IFSP.

c. The planning and design of activities, environments, and experiences to promote the normal development of an infant or toddler with a disability, consistent with the outcomes in the IFSP.

7. Covered Early Intervention services include the following functions when included in the IFSP and provided to an infant or toddler with a disability and the child's parent or other authorized caregiver by a certified Early Intervention professional or by a certified Early Intervention specialist under the supervision of a certified Early Intervention professional:

a. Providing families with information and training to enhance the development of the child.

b. Working with the child with a disability to promote normal development in one or more developmental domains.

c. Consulting with the child's family and other service providers to assess service needs; and plan, coordinate, and evaluate services to ensure that services reflect the unique needs of the child in all developmental domains.

C. The following functions shall not be covered under this section:

1. Screening to determine if the child is suspected of having a disability. Screening is covered as an EPSDT service provided by the primary care provider and is not covered as an Early Intervention service under this section.

2. Administration and coordination activities related to the development, review, and evaluation of the IFSP and procedural safeguards required by Part C of the Individuals with Disabilities Education Act (20 USC § 1431 et seq.).

3. Services other than the initial and periodic assessments that are provided but are not documented in the child's IFSP or linked to a service in the IFSP.

4. Sessions that are conducted for family support, education, recreational, or custodial purposes, including respite or child care.

5. Services provided by a relative who is legally responsible for the child's care.

6. Services rendered in a clinic or provider's office without justification for the location.

7. Services provided in the absence of the child and a parent or other authorized caregiver identified in the IFSP with the exception of multidisciplinary team meetings, which need not include the child.

D. Qualifications of providers:

1. Individual practitioners of Early Intervention services must be certified by DBHDS as a qualified Early Intervention professional or Early Intervention specialist and hold a valid Medicaid Early Intervention provider agreement.

2. Certified individuals and service agencies or groups who employ or contract with certified individuals may enroll with DMAS as Early Intervention providers. In accordance with 42 CFR 431.51, recipients may obtain Early Intervention services from any willing and qualified Medicaid provider who participates in this service.

3. Certified EI practitioners are qualified to provide a specialized rehabilitative service for young children with developmental delays. Certified individuals and agencies will enroll with DMAS and bill for this specialized rehabilitative service as an EPSDT Early Intervention provider rather than as a speech therapist, rehabilitation facility, or other designation. EI providers are certified or licensed to provide services within the scope of their practice as defined under state law. All licensed physical therapy and occupational therapy providers and those providing services for individuals with speech, hearing, and language disorders shall comply with the requirements of 42 CFR 440.110.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 29, Issue 2, eff. October 25, 2012.

12VAC30-50-132 Private duty nursing services under early and periodic screening, diagnostic, and treatment

A. This section applies to private duty nursing services for eligible individuals in fee-for-service programs. Individuals enrolled with managed care health plans receive private duty nursing services through their plans.

B. Service description. Private duty nursing services are individualized, medically necessary nursing care services consisting of skilled interventions, assessment, monitoring, and teaching of those who are or will be involved in nursing care for the individual. Private duty nursing services under the Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) benefit are provided when appropriate and medically necessary to correct and ameliorate a member's health conditions. As opposed to intermittent care provided under skilled nursing or home health nursing, private duty nursing is provided on a continuous or regularly scheduled basis according to medical necessity. Private duty nursing care provided can be based in the individual's home or any setting in which normal life activities take place. Congregate private duty nursing is defined as private duty nursing provided to two or more individuals who require private duty nursing in the same setting. Services are provided in accordance with 42 CFR 440.80.

C. Service components. Private duty nursing service is the management and administration of the treatment and care of an individual by a licensed nurse, within the scope of practice as outlined by the Virginia Board of Nursing. Private duty nursing service includes:

1. Assessments (e.g., respiratory assessment, patency of airway, vital signs, feeding assessment, seizure activity, hydration, level of consciousness, constant observation for comfort, and pain management);

2. Administration of treatment related to technological dependence (e.g., ventilator, tracheotomy, bi-level positive airway pressure (BiPAP), intravenous (IV) administration of medications and fluids, feeding pumps, nasal stents, and central lines);

3. Monitoring and maintaining parameters or machinery (e.g., oximetry, blood pressure, lab draws, end tidal CO₂s, ventilator, and tube feeding pumps);

4. Interventions (e.g., medications, suctioning, IVs, hyperalimentation, enteral feeds, ostomy care, and tracheostomy care); and

5. Exclusions from Department of Medical Assistance Services (DMAS) coverage of private duty nursing services include the following:

a. Not custodial or personal care delivered for the purpose of helping with activities of daily living (ADLs), including dressing, feeding, bathing, or transferring from a bed to a chair, and that can safely and effectively be performed by trained nonmedical personnel;

b. Monitoring for medically-controlled disorders as part of "maintenance of care"; and

c. Respite services.

D. Provider qualifications.

1. Private duty nursing providers shall meet the following requirements:

a. Operate from a business office;

b. Disclose ownership, if requested; and

c. Attest to the ability to document and maintain individual case records in accordance with state and federal requirements.

2. Private duty nursing must be provided by a registered nurse (RN) or licensed practical nurse (LPN) employed by (or subcontracted with) and supervised by a private duty nursing provider enrolled with DMAS.

a. The RN private duty nurse must possess the following qualifications:

(1) A license to practice in the Commonwealth of Virginia; and

(2) A satisfactory work history as evidenced by two satisfactory reference checks from prior job experience, including no evidence of abuse, neglect, or exploitation of incapacitated or older adults or children, recorded in the nurse's personnel file. If the RN has worked for a single employer, one satisfactory reference from a prior job experience and one personal reference, both with no evidence of abuse, neglect, or exploitation of an incapacitated or older adult or child, is acceptable, and the RN private duty nurse shall submit to a criminal record check obtained through the Virginia State Police. If the individual receiving services is a minor, the RN must also submit to a search of the Virginia Department of Social Services (VDSS) Child Protective Services (CPS) Central Registry. The provider shall not hire any RN with findings of barrier crimes identified in § 32.1-162.9:1 of the Code of Virginia or founded complaints in the VDSS CPS Central Registry.

b. An LPN shall meet the following requirements:

(1) Be licensed to practice in the Commonwealth of Virginia;

(2) Have a satisfactory work history as evidenced by two satisfactory reference checks from prior job experience, including no evidence of abuse, neglect, or exploitation of incapacitated or older adults or children, recorded in the nurse's personnel file. If the LPN has worked for a single employer, one satisfactory reference from a prior job experience and one personal reference, both with no evidence of abuse, neglect, or exploitation of an incapacitated or older adult or child, is acceptable; and

(3) Submit to a search of the VDSS CPS Central Registry if the individual receiving services is a minor child. The provider shall not hire any person who has been convicted of barrier crimes as identified in § 32.1-162.9:1 the Code of Virginia or has a founded complaint confirmed by the VDSS CPS Central Registry.

3. The RN or LPN must have (i) a documented provider training program or (ii) at least six months of related clinical nursing experience meeting the needs of the individual to receive care. Regardless of whether a nurse has six months of experience or completes a provider training course, the provider agency shall be responsible for ensuring all nurses who are assigned to an individual are competent in the care needs of that individual.

4. Nursing services must be provided under the supervision of a licensed RN supervisor in the Commonwealth.

a. RN supervisors shall meet the following requirements:

(1) Be verified as currently licensed to practice nursing in the Commonwealth;

(2) Have at least one year of verified related clinical nursing experience as an RN, which may include work in an acute care hospital, public health clinic, home health agency, rehabilitation hospital, or nursing facility; and

(3) Have a satisfactory work history as evidenced by two satisfactory reference checks from prior job experience, including no evidence of abuse, neglect, or exploitation of incapacitated or older adults or children, recorded in the nurse's personnel file. If the RN has worked for a single employer, one satisfactory reference from a prior job experience and one personal reference, both with no evidence of abuse, neglect, or exploitation of an incapacitated or older adult or child, is acceptable, and the RN supervisor shall submit to a criminal record check obtained through the Virginia State Police. If the individual receiving services is a minor, the RN supervisor must also submit to a search of the VDSS CPS Central Registry. The provider shall not hire any RN supervisor with findings of barrier crimes identified in § 32.1-162.9:1 of the Code of Virginia or founded complaints in the VDSS CPS Central Registry.

b. As part of direct supervision, the RN supervisor shall make, at a minimum, a visit every 30 days to ensure both quality and appropriateness of nursing services to assess the individual's and the individual's representative's satisfaction with the services being provided, to review the plan of care, and to update and verify the most current physician signed orders are in the home. When a delay occurs in the RN supervisor's visits because the individual is unavailable, the reason for the delay shall be documented in the individual's record, and the visit shall occur as soon as the individual is available. Failure to meet this standard may result in a DMAS recovery of payments made. Additional supervisory visits may be required under the following circumstances: (i) at the provider's discretion; (ii) at the request of the individual when a change in the individual's condition has occurred; (iii) any time the health, safety, or welfare of the individual could be at risk; and (iv) at the request of the DMAS staff. The RN is responsible for documentation of the visit's date, time, and evaluation.

c. The RN supervisor shall:

(1) Use and foster a person centered planning team approach to nursing services;

(2) Ensure choice of services is made by the individual, legally authorized guardian, or responsible party if a minor;

(3) Ensure personal goals of the individual are respected;

(4) Conduct the initial evaluation visit to initiate EPSDT private duty nursing services in the primary residence;

(5) Regularly evaluate the individual's status and nursing needs and notify the primary care provider if the individual no longer meets criteria for private duty nursing;

(6) Complete the Plan of Care and update as necessary for revisions;

(7) Ensure provision of those services requiring substantial and specialized nursing skill and that assigned nurses have the necessary licensure;

(8) Initiate appropriate preventive and rehabilitative nursing procedures;

(9) Perform an assessment at least every 30 days (the monthly nursing assessment cannot be made by the nurse providing care in the home). RN Monthly Supervisory Visits shall be completed in the primary residence at least every other visit. Visits may be conducted at school every other visit if necessary;

(10) Coordinate private duty nursing services;

(11) Inform the physician and case manager as appropriate of changes in the individual's condition and needs;

(12) Educate the individual and family or caregiver in meeting nursing and related goals;

(13) Supervise and educate other personnel involved in the individual's care;

(14) Ensure that required documentation is in the individual's agency record;

(15) Ensure that all employees are aware of the requirements to report suspected abuse, neglect, or exploitation immediately to Adult Protective Services or CPS, as appropriate. A civil penalty may be imposed on mandated reporters who do not report suspected abuse, neglect, or exploitation to VDSS as required;

(16) Ensure services are provided in a manner that is in the best interest of the individual and does not endanger the individual's health, safety, or welfare;

(17) Recommend staff changes when needed;

(18) Report to DMAS or the DMAS contractor any unethical or incompetent practices that jeopardize public safety or cause a risk of harm to individuals, including household issues that may jeopardize the safety of the private duty nurse; and

(19) Ensure that all nurses and caregivers are aware that timesheets must be accurate with arrival and departure times of the nurse and that falsifying timesheets is Medicaid fraud.

d. Parents (i.e., natural, step-parent, adoptive, foster parent, or other legal guardian), spouses, siblings, grandparents, grandchildren, adult children, or any person living under the same roof with the individual shall not provide private duty nursing services for the purpose of Medicaid reimbursement for the individual.

E. Service limits. Private duty nursing services are limited to the hours of skilled nursing care and medically-necessary supervision as specified in the Plan of Care signed by the child's physician (per §§ 54.1-2957 and 54.1-2957.02 of the Code of Virginia, signature by a nurse practitioner is acceptable in certain circumstances) and limited to the number of hours approved by DMAS or the DMAS contractor through the DMAS service authorization form (DMAS-62). Authorization of the number of medically necessary hours is based on assessing an individual's medical and support needs related to respiratory function, cardiovascular access and medications, wound care, feeding, central nervous system function, assessments that require the skills of a medical professional, toileting, and any other additional medical or support needs that require the skills of a licensed clinician. These medical and support needs are encompassed in the DMAS-62, and the number of hours approved will be based on medical needs final score, as detailed in the DMAS-62. Individuals younger than 21 years of age qualifying under EPSDT shall receive the services described in excess of any State Plan limit, up to 24 hours per day, if services are determined to be medically necessary to correct, ameliorate, or maintain the member's health condition and are prior authorized by the DMAS or the DMAS contractor.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia, 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 42, Issue 13, eff. March 26, 2026.

12VAC30-50-140 Physician's services whether furnished in the office, the patient's home, a hospital, a skilled nursing facility, or elsewhere

A. Elective surgery as defined by the Program is surgery that is not medically necessary to restore or materially improve a body function.

B. Cosmetic surgical procedures are not covered unless performed for physiological reasons and require Program prior approval.

C. Routine physicals and immunizations are covered.

D. Outpatient psychiatric services.

1. Psychiatric services can be provided by or under the supervision of an individual licensed under state law to practice medicine or osteopathy. Only the following licensed providers are permitted to provide psychiatric services under the supervision of an individual licensed under state law to practice medicine or osteopathy: an LMHP, LMHP-R, LMHP-RP, or LMHP-S as defined in 12VAC30-50-130, or a licensed school psychologist as defined in § 54.1-3600 of the Code of Virginia. Medically necessary psychiatric services shall be covered by the Department of Medical Assistance Services (DMAS) or its designee and shall be directly and specifically related to an active written plan designed and signature dated by one of the health care professionals listed in this subdivision.

2. Psychiatric services shall be considered appropriate when an individual meets the following criteria:

a. Requires treatment in order to sustain behavioral or emotional gains or to restore cognitive functional levels that have been impaired;

b. Exhibits deficits in peer relations, dealing with authority; is hyperactive; has poor impulse control; is clinically depressed or demonstrates other dysfunctional clinical symptoms having an adverse impact on attention and concentration, ability to learn, or ability to participate in employment, educational, or social activities;

c. Is at risk for developing or requires treatment for maladaptive coping strategies; and

d. Presents a reduction in individual adaptive and coping mechanisms or demonstrates extreme increase in personal distress.

E. Any procedure considered experimental is not covered.

F. Reimbursement for induced abortions is provided in only those cases in which there would be a substantial endangerment of life to the mother if the fetus was carried to term.

G. Physician visits to inpatient psychiatric hospital patients are restricted to medically necessary authorized (for enrolled providers) or approved (for nonenrolled providers) inpatient psychiatric hospital days as determined by DMAS or its contractor.

H. (Reserved.)

I. Reimbursement shall not be provided for physician services provided to recipients in the inpatient setting whenever the facility is denied reimbursement.

J. (Reserved.)

K. For the purposes of organ transplantation, all similarly situated individuals will be treated alike. Transplant services for kidneys, corneas, hearts, lungs, and livers shall be covered for all eligible persons. High dose chemotherapy and bone marrow or stem cell transplantation shall be covered for all eligible persons with a diagnosis of lymphoma, breast cancer, leukemia, or myeloma. Transplant services for any other medically necessary transplantation procedures that are determined to not be experimental or investigational shall be limited to children (younger than 21 years of age). Kidney, liver, heart, and bone marrow or stem cell transplants and any other medically necessary transplantation procedures that are determined to not be experimental or investigational require service authorization by DMAS. Cornea transplants do not require service authorization. The patient must be considered acceptable for coverage and treatment. The treating facility and transplant staff must be recognized as being capable of providing high-quality care in the performance of the requested transplant. Standards for coverage of organ transplant services are in 12VAC30-50-540 through 12VAC30-50-580.

L. Breast reconstruction or protheses following mastectomy and breast reduction.

1. If prior authorized, breast reconstruction surgery and prostheses may be covered following the medically necessary complete or partial removal of a breast for any medical reason. Breast reductions shall be covered, if prior authorized, for all medically necessary indications. Such procedures shall be considered noncosmetic.

2. Breast reconstruction or enhancements for cosmetic reasons shall not be covered. Cosmetic reasons shall be defined as those that are not medically indicated or are intended solely to preserve, restore, confer, or enhance the aesthetic appearance of the breast.

M. Admitting physicians shall comply with the requirements for coverage of out-of-state inpatient hospital services. Inpatient hospital services provided out of state to a Medicaid recipient who is a resident of the Commonwealth of Virginia shall only be reimbursed under at least one of the conditions in subdivisions 1 through 4 of this subsection. It shall be the responsibility of the hospital, when requesting service authorization for the admission, to demonstrate that one of the conditions in subdivisions 1 through 4 of this subsection exists in order to obtain authorization. Services provided out of state for circumstances other than these specified reasons shall not be covered.

1. The medical services must be needed because of a medical emergency;

2. Medical services must be needed and the recipient's health would be endangered if the recipient were required to travel to his state of residence;

3. The state determines, on the basis of medical advice, that the needed medical services, or necessary supplementary resources, are more readily available in the other state; or

4. It is general practice for recipients in a particular locality to use medical resources in another state.

N. In compliance with 42 CFR Part 441 Subparts E and F, claims for hospitalization in which sterilization, hysterectomy, or abortion procedures were performed shall be subject to review of the required DMAS forms corresponding to the procedures. The claims shall suspend for manual review by DMAS. If the forms are not properly completed or not attached to the bill, the claim will be denied or reduced according to DMAS policy.

O. Prior authorization is required for the following nonemergency outpatient procedures: Magnetic Resonance Imaging (MRI), including Magnetic Resonance Angiography (MRA), Computerized Axial Tomography (CAT) scans, including Computed Tomography Angiography (CTA), or Positron Emission Tomography (PET) scans performed for the purpose of diagnosing a disease process or physical injury. The referring physician ordering nonemergency outpatient Magnetic Resonance Imaging (MRI), Computerized Axial Tomography (CAT) scans, or Positron Emission Tomography (PET) scans must obtain prior authorization from DMAS for those scans. The servicing provider will not be reimbursed for the scan unless proper prior authorization is obtained from DMAS by the referring physician.

P. Addiction and recovery treatment services shall be covered in physician services consistent with Part XX (12VAC30-130-5000 et seq) of this chapter.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-03-3.1100 § 5, eff. April 1, 1993; amended, eff. June 30, 1993; amended, eff. July 19, 1993; amended, eff. June 29, 1994; amended, Virginia Register Volume 11, Issue 13, eff. April 19, 1995; Volume 11, Issue 17, eff. July 1, 1995; Volume 12, Issue 3, eff. November 29, 1995; Volume 13, Issue 1, eff. November 1, 1996; Volume 14, Issue 7, eff. January 21, 1998; Volume 14, Issue 12, eff. April 1, 1998; Volume 14, Issue 18, July 1, 1998; Volume 15, Issue 5, eff. January 1, 1999; Volume 15, Issue 6, eff. January 6, 1999; Volume 15, Issue 24, eff. September 15, 1999; Volume 16, Issue 18, eff. July 1, 2000; Volume 18, Issue 6, eff. January 2, 2002; Volume 18, Issue 7, eff. January 16, 2002; Volume 19, Issue 18, eff. July 1, 2003; Volume 20, Issue 1, eff. October 22, 2003; Volume 20, Issue 19, eff. July 1, 2004; Volume 22, Issue 16, eff. July 3, 2006; Volume 26, Issue 8, eff. January 21, 2010; Volume 26, Issue 19, eff. July 1, 2010; Volume 33, Issue 12, eff. April 1, 2017; Volume 33, Issue 22, eff. July 26, 2017; Volume 35, Issue 5, eff. December 13, 2018; Volume 37, Issue 2, eff. October 30, 2020; Volume 39, Issue 5, eff. December 8, 2022; Volume 41, Issue 26, eff. September 25, 2025.

12VAC30-50-150 Medical care by other licensed practitioners within the scope of their practice as defined by state law

A. Podiatrists' services.

1. Covered podiatry services are defined as reasonable and necessary diagnostic, medical, or surgical treatment of disease, injury, or defects of the human foot. These services must be within the scope of the license of the podiatrists' profession and defined by state law.

2. The following services are not covered: preventive health care, including routine foot care; treatment of structural misalignment not requiring surgery; cutting or removal of corns, warts, or calluses; experimental procedures; acupuncture.

3. The Program may place appropriate limits on a service based on medical necessity or for utilization control, or both.

B. Optometrists' services. Diagnostic examination and optometric treatment procedures and services by ophthalmologists, optometrists, and opticians, as allowed by the Code of Virginia and by regulations of the Boards of Medicine and Optometry, are covered for all recipients. Routine refractions are limited to once in 24 months except as may be authorized by the agency.

C. Chiropractors' services are not provided.

D. In accordance with 42 CFR 440.60, licensed practitioners (including an LMHP, LMHP-R, LMHP-RP, or LMHP-S as defined in 12VAC30-50-130 or a licensed school psychologist as defined in § 54.1-3600 of the Code of Virginia) may provide medical care or any other type of remedial care or services, other than physician's services, within the scope of practice as defined by state law.

E. Addiction and recovery treatment services shall be covered in other licensed practitioner services consistent with Part XX (12VAC30-130-5000 et seq.) of 12VAC30-130.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-03-3.1100 § 6, eff. January 4, 1990; amended, eff. September 1, 1993; amended, Virginia Register Volume 11, Issue 17, eff. July 1, 1995; Volume 12, Issue 3, eff. November 29, 1995; Volume 14, Issue 12, eff. April 1, 1998; Volume 15, Issue 6, eff. January 6, 1999; Volume 19, Issue 18, eff. July 1, 2003; Volume 20, Issue 1, eff. October 22, 2003; Volume 20, Issue 19, eff. July 1, 2004; Volume 22, Issue 16, eff. July 3, 2006; Volume 26, Issue 8, eff. January 21, 2010; Volume 33, Issue 12, eff. April 1, 2017; Volume 33, Issue 22, eff. July 26, 2017; Volume 35, Issue 5, eff. December 13, 2018; Volume 39, Issue 5, eff. December 8, 2022.

12VAC30-50-160 Home health services

A. Service must be ordered or prescribed by a physician, nurse practitioner (NP), clinical nurse specialist (CNS), or physician assistant (PA). Services shall be directed or performed within the scope of a license of a practitioner of the healing arts. Home health services shall be provided in accordance with guidelines found in the Virginia Medicaid Home Health Manual.

B. Nursing services provided by a home health agency.

1. Intermittent or part-time nursing service provided by a home health agency or by a registered nurse when no home health agency exists in the area.

2. Patients may receive up to five visits by a licensed nurse annually. Limits are per recipient, regardless of the number of providers rendering services. "Annually" shall be defined as July 1 through June 30 for each recipient. If services beyond these limitations are determined by a practitioner, as defined in subsection A of this section, to be required, then the provider shall request prior authorization from DMAS for additional services. Payment shall not be made for additional service unless authorized by DMAS.

C. Home health aide services provided by a home health agency.

1. Home health aides must function under the supervision of a registered nurse.

2. Home health aides must meet the certification requirements specified in 42 CFR 484.80.

3. For home health aide services, patients may receive up to 32 visits annually. Limits shall be per recipient, regardless of the number of providers rendering services. "Annually" shall be defined as July 1 through June 30 for each recipient.

D. Physical therapy, occupational therapy, or speech pathology services and audiology services provided by a home health agency or medical rehabilitation facility.

1. Service covered only as part of a plan of care developed by a practitioner, as defined in subsection A of this section.

2. Patients may receive up to five visits for each rehabilitative therapy service ordered annually without authorization. Limits shall apply per recipient regardless of the number of providers rendering services. "Annually" shall be defined as July 1 through June 30 for each recipient. If services beyond these limitations are determined by the practitioner, as defined in subsection A of this section, to be required, then the provider shall request prior authorization from DMAS for additional services.

E. The following services are not covered under the home health services program:

1. Medical social services;

2. Services or items which would not be paid for if provided to an inpatient of a hospital, such as private-duty nursing services, or items of comfort which have no medical necessity, such as television;

3. Community food service delivery arrangements;

4. Domestic or housekeeping services that are unrelated to patient care and that materially increase the time spent on a visit;

5. Custodial care, which is patient care that primarily requires protective services rather than definitive medical and skilled nursing care; and

6. Services related to cosmetic surgery.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-03-3.1100 § 7, eff. September 1, 1993; amended, Virginia Register Volume 11, Issue 17, eff. July 1, 1995; Volume 12, Issue 16, eff. July 1, 1996; Volume 12, Issue 18, eff. July 1, 1996; Volume 13, Issue 7, eff. February 1, 1997; Volume 14, Issue 18, eff. July 1, 1998; Volume 16, Issue 2, eff. November 10, 1999; Volume 18, Issue 10, eff. February 27, 2002; Volume 19, Issue 18, eff. July 1, 2003; Volume 33, Issue 25, eff. January 13, 2018; Volume 36, Issue 24, eff. August 19, 2020.

12VAC30-50-165 Durable medical equipment suitable for use in the home

A. Definitions. The following words and terms when used in this section shall have the following meanings unless the context clearly indicates otherwise:

"Affirmative contact" means speaking, either face-to-face or by phone, with either the individual or caregiver in order to ascertain that the DME is still needed and appropriate. Such contacts shall be documented in the individual's medical record.

"Certificate of Medical Necessity" or "CMN" means the DMAS-352 form required to be completed and submitted in order for DMAS to provide reimbursement.

"Complex rehabilitation technology" or "CRT" means manual and powered wheelchairs and their accessories that are customized and individually configured to meet the specific medical, physical, and functional needs of the individual who has a primary diagnosis resulting from a congenital disorder, progressive or degenerative neuromuscular disease, or from certain types of injury or trauma.

"Designated agent" means an entity with whom DMAS has contracted to perform functions such as provider audits and prior authorizations of services.

"DMAS" means the Department of Medical Assistance Services.

"DME provider" means those entities enrolled with DMAS to render DME services.

"Durable medical equipment" or "DME" means medical equipment, supplies, and appliances suitable for use in the home consistent with 42 CFR 440.70(b)(3) that treat a diagnosed condition or assist the individual with functional limitations.

"Enteral nutrition" refers to any method of feeding that uses the gastrointestinal tract to deliver part or all of an individual's caloric requirements. "Enteral nutrition" may include a routine oral diet, the use of liquid supplements, or delivery of part or all of the daily requirements by use of a tube, which is called tube feeding.

"Expendable supply" means an item that is used and then disposed of.

"Frequency of use" means the rate of use by the individual as documented by the number of times per day, week, or month, as appropriate, a supply is used by the individual. Frequency of use must be recorded on the face of the CMN in such a way that reflects whether a supply is used by the individual on a daily, weekly, or monthly basis. Frequency of use may be documented on the CMN as a range of the rate of use. By way of example and not limitation, the frequency of use of a supply may be expressed as a range, such as four to six adult diapers per day. However, large ranges shall not be acceptable documentation of frequency of use, for example, the range of one to six adult diapers per day shall not be acceptable. The frequency of use provides the justification for the total quantity of supplies ordered on the CMN.

"Functional limitation" means the inability to perform a normal activity.

"Practitioner" means a licensed provider of physician services as defined in 42 CFR 440.50.

"Prior authorization" or "PA" means the process of approving either by DMAS or its prior authorization contractor for the purposes of DMAS reimbursement for the service for the individual before it is rendered or reimbursed.

"Quantity" means the total number of supplies ordered on a monthly basis as reflected on the CMN. The monthly quantity of supplies ordered for the individual shall be dependent upon the individual's frequency of use.

B. General requirements and conditions.

1. a. All medically necessary supplies and equipment shall be covered. Unusual amounts, types, and duration of usage must be authorized by DMAS in accordance with published policies and procedures. When determined to be cost effective by DMAS, payment may be made for rental of the equipment in lieu of purchase.

b. No provider shall have a claim of ownership on DME reimbursed by Virginia Medicaid once it has been delivered to theMedicaid individual . Providers shall only be permitted to recover DME, for example, when DMAS determines that it does not fulfill the required medically necessary purpose as set out in the Certificate of Medical Necessity, when there is an error in the ordering practitioner's CMN, or when the equipment was rented.

2. DME providers shall adhere to all applicable federal and state laws and regulations and DMAS policies for DME. DME providers shall comply with all other applicable Virginia laws and regulations requiring licensing, registration, or permitting. Failure to comply with such laws and regulations that are required by a licensing agency shall result in denial of coverage for DME.

3. DME must be furnished pursuant to a properly completed Certificate of Medical Necessity (CMN) (DMAS-352). In order to obtain Medicaid reimbursement, specific fields of the DMAS-352 form shall be completed as specified in 12VAC30-60-75.

4. DME shall be ordered by the licensed practitioner and shall be related to medical treatment of the Medicaid individual. The complete DME order shall be recorded on the CMN for Medicaid individuals to receive such services. In the absence of a different effective period determined by DMAS or its designated agent, the CMN shall be valid for a maximum period of six months for Medicaid individuals younger than 21 years of age. In the absence of a different effective period determined by DMAS or its designated agent, the maximum valid time period for CMNs for Medicaid individuals 21 years of age and older shall be 12 months. The validity of the CMN shall terminate when the individual's medical need for the prescribed DME no longer exists as determined by the licensed practitioner.

5. DME shall be furnished exactly as ordered by the licensed practitioner who signed the CMN. The CMN and any supporting verifiable documentation shall be fully completed, signed, and dated by the licensed practitioner, and in the DME provider's possession within 60 days from the time the ordered DME is initially furnished by the DME provider. Each component of the DME shall be specifically ordered on the CMN by the licensed practitioner.

6. The CMN shall not be changed, altered, or amended after the licensed practitioner has signed it. If the individual's condition indicates that changes in the ordered DME are necessary, the DME provider shall obtain a new CMN. All new CMNs shall be signed and dated by the licensed practitioner within 60 days from the time the ordered supplies are furnished by the DME provider.

7. DMAS or its designated agent shall have the authority to determine a different length of time from those specified in subdivisions 4, 5, and 6 of this subsection that a CMN may be valid based on medical documentation submitted on the CMN. The CMN may be completed by the DME provider or other appropriate health care professionals, but it shall be signed and dated by the licensed practitioner, as specified in subdivision 5 of this subsection. Supporting documentation may be attached to the CMN but the licensed practitioner's entire order for DME shall be on the CMN.

8. The DME provider shall retain a copy of the CMN and all supporting verifiable documentation on file for purposes of the DMAS post payment audit review. DME providers shall not create or revise CMNs or supporting documentation for this service after the initiation of the post payment review audit process. Licensed practitioners shall not complete, sign, or date CMNs once the post payment audit review has begun.

9. The DME provider shall be responsible for knowledge of items requiring prior authorization and the limitation on the provision of certain items as described in the Virginia Medicaid Durable Medical Equipment and Supplies Manual, Appendix B. Appendix B shall be the official listing of all items covered through the Virginia Medicaid DME program and list the service limits, items that require prior authorization, billing units, and reimbursement rates.

10. The DME provider shall be required to make affirmative contact with the individual or the individual's caregiver and document the interaction prior to the next month's delivery and prior to the recertification CMN to ensure that the appropriate quantity, frequency, and product are provided to the individual.

11. Supporting documentation, added to a completed CMN, shall be allowed to further justify the medical need for DME. Supporting documentation shall not replace the requirement for a properly completed CMN. The dates of the supporting documentation shall coincide with the dates of service on the CMN, and the supporting documentation shall be signed and dated by the licensed practitioner.

C. The billing unit for incontinence supplies (such as diapers, pull-ups, and panty liners) shall be by each product. For example, if the incontinence supply being provided is diapers, the billing unit would be by individual diaper, rather than a case of diapers. Prior authorization shall be required for incontinence supplies provided in quantities greater than the allowable service limit per month.

D. Supplies, equipment, or appliances that are not covered include the following:

1. Space conditioning equipment, such as room humidifiers, air cleaners, and air conditioners;

2. DME for any hospital or nursing facility resident. For nursing facility residents, an exception is made for (i) ventilators and associated supplies; (ii) specialty beds for the treatment of wounds; and (iii) complex rehabilitation technology manual and power wheelchair bases and related accessories that have been prior approved by DMAS or designated agent;

3. Furniture or appliances not defined as medical equipment (such as blenders, bedside tables, mattresses other than for a hospital bed, pillows, blankets or other bedding, special reading lamps, chairs with special lift seats, hand-held shower devices, exercise bicycles, and bathroom scales);

4. Items that are only for the individual's comfort and convenience or for the convenience of those caring for the individual (e.g., a hospital bed or mattress because the individual does not have a bed; wheelchair trays used as a desk surface); mobility items used in addition to primary assistive mobility aide for the convenience of the individual or the individual's caregiver (e.g., an electric wheelchair plus a manual chair); and cleansing wipes;

5. Prosthesis, except for artificial arms, legs, and their supportive devices, which shall be prior authorized by DMAS or designated agent;

6. Items and services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member (e.g., dentifrices; toilet articles; shampoos that do not require a licensed practitioner's prescription; dental adhesives; electric toothbrushes; cosmetic items, soaps, and lotions that do not require a licensed practitioner's prescription; sugar and salt substitutes; and support stockings);

7. Orthotics, including braces, diabetic shoe inserts, splints, and supports;

8. Home or vehicle modifications;

9. Items not suitable for or not used primarily in the home setting (e.g., car seats, equipment to be used while at school, etc.);

10. Equipment for which the primary function is vocationally or educationally related (e.g., computers, environmental control devices, speech devices, etc.);

11. Diapers for routine use by children younger than three years of age who have not yet been toilet trained;

12. Equipment or items that are not suitable for use in the home; and

13. Equipment or items that the Medicaid individual or the individual's caregiver is unwilling or unable to use in the home.

E. For coverage of blood glucose meters for pregnant women, refer to 12VAC30-50-510.

F. Coverage of home infusion therapy.

1. Home infusion therapy shall be defined as the administration of fluids, drugs, chemical agents, or nutritional substances to individuals through intravenous (I.V.) therapy or an implantable pump in the home setting. DMAS shall reimburse for these services, supplies, and drugs on a service day rate methodology established in 12VAC30-80-30. The therapies to be covered under this policy shall be: hydration therapy, chemotherapy, pain management therapy, drug therapy, and total parenteral nutrition (TPN). All the therapies that meet criteria shall be covered and do not require prior authorization. The established service day rate shall reimburse for all services delivered in a single day. There shall be no additional reimbursement for special or extraordinary services. In the event of incompatible drug administration, a separate HCPCS code shall be used to allow for rental of a second infusion pump and purchase of an extra administration tubing. When applicable, this code may be billed in addition to the other service day rate codes. There shall be documentation to support the use of this code on the I.V. Implementation Form. Proper documentation shall include the need for pump administration of the medications ordered, frequency of administration to support that they are ordered simultaneously, and indication of incompatibility.

2. The service day rate payment methodology shall be mandatory for reimbursement of all I.V. therapy services except for the individual who is enrolled in the Technology Assisted Waiver.

3. The following limitations shall apply to this service:

a. This service must be medically necessary to treat an individual's medical condition. The service must be ordered and provided in accordance with accepted medical practice. The service must not be desired solely for the convenience of the individual or the individual's caregiver.

b. In order for Medicaid to reimburse for this service, the individual shall:

(1) Reside in either a private home or a domiciliary care facility, such as an assisted living facility. Because the reimbursement for DME is already provided under institutional reimbursement, individuals in hospitals, nursing facilities, rehabilitation centers, and other institutional settings shall not be covered for this service;

(2) Be under the care of a licensed practitioner who prescribes the home infusion therapy and monitors the progress of the therapy;

(3) Have body sites available for peripheral intravenous catheter or needle placement or have a central venous access; and

(4) Be capable of either self-administering such therapy or have a caregiver who can be adequately trained, is capable of administering the therapy, and is willing to safely and efficiently administer and monitor the home infusion therapy. The caregiver must be willing to and be capable of following appropriate teaching and adequate monitoring. In cases where the individual is incapable of administering or monitoring the prescribed therapy and there is no adequate or trained caregiver, it may be appropriate for a home health agency to administer the therapy.

G. The DME vendor shall provide the equipment and supplies as prescribed by the licensed practitioner on the CMN. Orders shall not be changed unless the vendor obtains a new CMN, which includes the licensed practitioner's signature, prior to ordering the equipment or supplies or providing the equipment or supplies to the individual.

H. Medicaid shall not provide reimbursement to the DME vendor for services that are provided (i) prior to the date prescribed by the licensed practitioner; (ii) prior to the date of the delivery; or (iii) when services are not provided in accordance with DMAS published regulations and guidance documents. If reimbursement is denied for one or all of these reasons, the DME vendor shall not bill the Medicaid individual for the service that was provided.

I. The following criteria shall be satisfied through the submission of adequate and verifiable documentation on the CMN satisfactory to DMAS. Medically necessary DME shall be:

1. Ordered by the licensed practitioner on the CMN;

2. A reasonable and necessary part of the individual's treatment plan;

3. Consistent with the individual's diagnosis and medical condition, particularly the functional limitations and symptoms exhibited by the individual;

4. Not furnished solely for the convenience, safety, or restraint of the individual, the family or caregiver, the licensed practitioner, or other licensed practitioner or supplier;

5. Consistent with generally accepted professional medical standards (i.e., not experimental or investigational); and

6. Furnished at a safe, effective, and cost-effective level suitable for use in the individual's home environment.

J. Medical documentation shall provide DMAS or the designated agent with evidence of the individual's DME needs. Medical documentation may be recorded on the CMN or evidenced in the supporting documentation attached to the CMN. The following applies to the medical justification necessary for all DME services regardless of whether prior authorization is required. The documentation is necessary to identify:

1. The medical need for the requested DME;

2. The diagnosis related to the reason for the DME request;

3. The individual's functional limitation and its relationship to the requested DME;

4. How the DME service will treat the individual's medical condition;

5. For expendable supplies, the quantity needed and the medical reason the requested amount is needed;

6. The frequency of use to describe how often the DME is used by the individual;

7. The estimated duration of use of the equipment (rental and purchased);

8. Any other treatment being rendered to the individual relative to the use of DME;

9. How the needs were previously met, identifying changes that have occurred that necessitate the DME;

10. Other alternatives tried or explored and a description of the success or failure of these alternatives;

11. How the DME service is required in the individual's home environment; and

12. The individual's or the individual's caregiver's ability, willingness, and motivation to use the DME.

K. DME provider responsibilities. To receive reimbursement, the DME provider shall, at a minimum, perform the following:

1. Verify the individual's current Medicaid eligibility;

2. Determine whether the ordered items are a covered service and require prior authorization;

3. Deliver all items ordered by the licensed practitioner;

4. Deliver only the quantities ordered by the licensed practitioner on the CMN and prior authorized by DMAS if required;

5. Deliver only the items for the periods of service covered by the licensed practitioner's order and prior authorized, if required, by DMAS;

6. Maintain a copy of the licensed practitioner's signed CMN and all verifiable supporting documentation for all DME ordered;

7. Document and justify the description of services (i.e., labor, repairs, maintenance of equipment);

8. Document and justify the medical necessity, frequency, and duration for all items and supplies as set out in the Medicaid DME guidance documents;

9. Document all DME provided to an individual in accordance with the licensed practitioner's orders. The delivery ticket or proof of delivery shall document the requirements as stated in subsection L of this section; and

10. Meet documentation requirements for the use of DME billing codes that have Individual Consideration (IC) indicated as the reimbursement fee to include a complete description of the items, a copy of the supplies invoices or the manufacturer's cost information, and all discounts that were received by the DME provider. Additional information regarding requirements for the IC reimbursement process can be found in the relevant agency guidance document.

L. Proof of delivery.

1. The delivery ticket shall contain the following information:

a. The Medicaid individual's name and Medicaid number or date of birth or a unique identifier (e.g., an individual's medical record number);

b. A detailed description of the items being delivered, including the product names and brands;

c. The serial numbers or the product numbers of the DME, if available;

d. The quantity delivered; and

e. The dated signature of either the individual or the individual's caregiver.

2. If a commercial shipping service is used, the DME provider's records shall reference, in addition to the information required in subdivision 1 of this subsection, the delivery service's package identification numbers with a copy of the delivery service's delivery ticket, which may be printed from the online record on the delivery service's website.

a. The delivery service's ticket identification numbers shall be recorded on the DME provider's delivery documentation.

b. The service delivery documentation may be substituted for the individual's signature as proof of delivery.

c. In the absence of a delivery service's ticket, the DME provider shall obtain the individual's or the individual's caregiver's dated signature on the DME provider's delivery ticket as proof of delivery.

3. Providers may use a postage-paid delivery invoice from the individual or the individual's caregiver as a form of proof of delivery. The descriptive information concerning the items delivered, as described in subdivisions 1 and 2 of this subsection, as well as the required signature and date from either the individual or the individual's caregiver, shall be included on this invoice.

4. DME providers shall make affirmative contact with the individual or the individual's caregiver and document the interaction prior to dispensing repeat orders or refills to ensure that:

a. The item is needed;

b. The quantity, frequency, and product are appropriate; and

c. The individual resides at the address in the provider's records.

5. The DME provider shall contact the individual prior to each delivery. This contact shall not occur any sooner than seven days prior to the delivery or shipping date and shall be documented in the individual's record.

6. DME providers shall not deliver refill orders sooner than five days prior to the end of the usage period.

7. Providers shall not bill for dates of service prior to delivery. The provider shall confirm receipt of the DME via the shipping service record showing the item was delivered prior to billing. Claims for refill orders shall be the start of the new usage period and shall not overlap with the previous usage period.

8. The purchase prices listed in the Virginia Medicaid Durable Medical Equipment and Supplies Manual, Appendix B, represent the amount DMAS shall pay for newly purchased equipment. Unless otherwise approved by DMAS or its designated agent, documentation on the delivery ticket shall reflect that the purchased equipment is new upon the date of the service billed. Any warranties associated with new equipment shall be effective from the date of the service billed. Since Medicaid is the payer of last resort, the DME provider shall explore coverage available under the warranty prior to requesting coverage of repairs from DMAS.

9. DME for home use for an individual being discharged from a hospital or nursing facility may be delivered to the hospital or nursing facility one day prior to the discharge. However, the DME provider's claim date of service shall not begin prior to the date of the individual's discharge from the hospital or nursing facility.

M. Enteral nutrition products. Coverage of enteral nutrition (EN) that does not include a legend drug shall be limited to when the nutritional supplement is administered orally or through a nasogastric or gastrostomy tube and is necessary to treat a medical condition. DMAS shall provide coverage for nutritional supplements for enteral feeding only if the nutritional supplements are not available over the counter. Additionally, DMAS shall cover medical foods that are (i) specific to inherited diseases and metabolic disorders; (ii) not generally available in grocery stores, health food stores, or the retail section of a pharmacy; and (iii) not used as food by the general population. Coverage of EN shall not include the provision of routine infant formula or feedings as meal replacement only. Coverage of medical foods shall not extend to regular foods prepared to meet particular dietary restrictions, limitations, or needs, such as meals designed to address the situation of individuals with diabetes or heart disease. A nutritional assessment shall be required for all individuals for whom nutritional supplements are ordered.

1. General requirements and conditions.

a. Enteral nutrition products shall only be provided by enrolled DME providers.

b. DME providers shall adhere to all applicable DMAS policies, laws, and regulations. DME providers shall also comply with all other applicable Virginia laws and regulations requiring licensing, registration, or permitting. Failure to comply with such laws and regulations shall result in denial of coverage for enteral nutrition that is regulated by such licensing agency.

2. Service units and service limitations.

a. DME shall be furnished pursuant to the Certificate of Medical Necessity (DMAS-352).

b. The DME provider shall include documentation related to the nutritional evaluation findings on the CMN and may include supplemental information on any supportive documentation submitted with the CMN.

c. DMAS shall reimburse for medically necessary formulae and medical foods when used under a licensed practitioner's direction to augment dietary limitations or provide primary nutrition to individuals via enteral or oral feeding methods.

d. The CMN shall contain a licensed practitioner's order for the enteral nutrition products that are medically necessary to treat the diagnosed condition and the individual's functional limitation. The justification for enteral nutrition products shall be demonstrated in the written documentation either on the CMN or on the attached supporting documentation. The CMN shall be valid for a maximum period of six months.

e. Regardless of the amount of time that may be left on a six-month approval period, the validity of the CMN shall terminate when the individual's medical need for the prescribed enteral nutrition products ends, as determined by the licensed practitioner.

f. A face-to-face nutritional assessment completed by trained clinicians (e.g., physician, physician assistant, nurse practitioner, registered nurse, or a registered dietitian) shall be completed as required documentation of the need for enteral nutrition products.

g. Prior authorization of enteral nutrition products shall not be required. The DME provider shall ensure that there is a valid CMN (i) completed every six months in accordance with subsection B of this section and (ii) on file for all Medicaid individuals for whom enteral nutrition products are provided.

(1) The DME provider is further responsible for ensuring that enteral nutrition products are provided in accordance with DMAS reimbursement criteria in 12VAC30-80-30 A 6.

(2) Upon post payment review, DMAS or its designated contractor may deny reimbursement for any enteral nutrition products that have not been provided and billed in accordance with this section and DMAS policies.

h. DMAS shall have the authority to determine that the CMN is valid for less than six months based on medical documentation submitted.

3. Provider responsibilities.

a. The DME provider shall provide the enteral nutrition products as prescribed by the licensed practitioner on the CMN. Physician orders shall not be changed unless the DME provider obtains a new CMN prior to ordering or providing the enteral nutrition products to the individual.

b. The licensed practitioner's order on the CMN shall specify either a brand name of the enteral nutrition product being ordered or the category of enteral nutrition products that must be provided. If a licensed practitioner orders a specific brand of enteral nutrition product, the DME provider shall supply the brand prescribed. The licensed practitioner order shall include the daily caloric intake and the route of administration for the enteral nutrition product. Supporting documentation may be attached to the CMN, but the entire licensed practitioner's order shall be on the CMN.

c. The CMN shall be signed and dated by the licensed practitioner within 60 days of the CMN begin service date. The order shall not be backdated to cover prior dispensing of enteral nutrition products. If the CMN is not signed and dated by the licensed practitioner within 60 days of the CMN begin service date, the CMN shall become valid on the date of the licensed practitioner's signature.

d. The CMN shall include all of the following elements:

(1) Height of individual (or length for pediatric patients);

(2) Weight of individual. For initial assessments, indicate the individual's weight loss over time;

(3) Tolerance of enteral nutrition product (e.g., is the individual experiencing diarrhea, vomiting, constipation). This element is only required if the individual is already receiving enteral nutrition products;

(4) Route of administration; and

(5) The daily caloric order and the number of calories per package or can.

e. Medicaid reimbursement shall be recovered when the enteral nutrition products have not been ordered on the CMN. Supporting documentation is allowed to justify the medical need for enteral nutrition products. Supporting documentation shall not replace the requirement for a properly completed CMN. The dates of the supporting documentation shall coincide with the dates of service on the CMN, and the supporting documentation shall be signed and dated by the licensed practitioner.

N. Reimbursement denials.

1. DMAS shall deny payment to the DME provider if any of the following occur:

a. Absence of a current, fully completed CMN appropriately signed and dated by the licensed practitioner;

b. Documentation does not verify that the item was provided to the individual;

c. Lack of medical documentation, signed by the licensed practitioner to justify the DME; or

d. Item is noncovered or does not meet DMAS criteria for reimbursement.

2. If reimbursement is denied by Medicaid, the DME provider shall not bill the Medicaid individual for the service that was provided.

O. Replacement DME following a disaster.

1. Medicaid individuals who (i) live in areas that have been declared by the Governor to be subject to a state of emergency in accordance with § 44-146.16 of the Code of Virginia, (ii) live in Virginia and were present in an area of the state that has been declared by the Governor to be subject to a state of emergency in accordance with § 44-146.16 of the Code of Virginia, or (iii) live in Virginia and can prove they were present in a state or federally declared disaster or emergency area in another state when the disaster occurred, and who need to replace DME previously approved by Medicaid that were damaged as a result of the disaster or emergency, may contact a DME provider (either enrolled in fee-for-service Medicaid or a Medicaid health plan) of their choice to obtain a replacement.

a. If the individual's DME provider has gone out of business or is unable to provide replacement DME, the individual may choose another provider who is enrolled as a DME provider with Medicaid or the Medicaid health plan. The original authorization will be canceled or amended and a new authorization will be provided to the new DME provider.

b. The DME provider shall submit a signed statement from the Medicaid individual requesting a change in DME provider in accordance with the declaration by the Governor as a state of emergency due to a disaster and giving the Medicaid individual's current place of residence.

c. The individual can contact the state Medicaid office or the Medicaid health plan to get help finding a new DME provider.

2. For Medicaid enrolled providers, the provider shall make a request to the service authorization contractor; however, a new CMN and medical documentation is not required unless the DME is beyond the service limit (e.g., the individual has a wheelchair that is older than five years). The provider shall keep documentation in the individual's record that includes the individual's current place of residence and states that the original DME was lost due to the disaster.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 10, eff. February 27, 2002; amended, Virginia Register Volume 26, Issue 4, eff. January 1, 2010; Volume 28, Issue 19, eff. July 1, 2012; Volume 36, Issue 10, eff. February 21, 2020; Volume 41, Issue 10, eff. February 13, 2025.

12VAC30-50-170 Private duty nursing services

Private duty nursing services are not provided unless an individual receives services under Early and Periodic Screening, Diagnostic and Treatment Services or a § 1915(c) Waiver.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-03-3.1100 § 8, eff. September 1, 1993; amended, Virginia Register Volume 10, Issue 22, eff. September 1, 1994; Volume 12, Issue 3, eff. November 29, 1995; Volume 42, Issue 13, eff. March 26, 2026.

12VAC30-50-180 Clinic services

A. Reimbursement for induced abortions is provided in only those cases in which there would be a substantial endangerment of life to the mother if the fetus were carried to term.

B. Clinic services means preventive, diagnostic, therapeutic, rehabilitative, or palliative items or services that:

1. Are provided to outpatients;

2. Are provided by a facility that is not part of a hospital but is organized and operated to provide medical care to outpatients; and

3. Except in the case of nurse-midwife services, as specified in 42 CFR 440.165, are furnished by or under the direction of a physician or dentist.

C. Reimbursement to community mental health clinics for psychotherapy services is provided only when performed by a qualified therapist. For purposes of this section, a qualified therapist is:

1. A licensed physician who has completed three years of post-graduate residency training in psychiatry; or

2. An individual licensed by one of the boards administered by the Department of Health Professions to provide psychotherapy services including: (i) a licensed clinical psychologist; (ii) a LMHP-RP, as defined in 12VAC30-50-130; (iii) a licensed psychiatric nurse practitioner; (iv) a licensed clinical social worker; (v) a LMHP-S, as defined in 12VAC30-50-130; (vi) a licensed professional counselor; (vii) a LMHP-R, as defined in 12VAC30-50-130; (viii) a clinical nurse specialist-psychiatric; (ix) a licensed marriage and family therapists.

D. Addiction and recovery treatment services shall be covered in clinics consistent with 12VAC30-130-5000 et seq.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-03-3.1100 § 9, eff. July 1, 1989; amended, eff. September 1, 1993; Virginia Register Volume 10, Issue 22, eff. September 1, 1994; Volume 16, Issue 19, eff. July 5, 2000; Volume 20, Issue 19, eff. July 1, 2004; Volume 26, Issue 8, eff. January 21, 2010; Volume 26, Issue 19, eff. July 1, 2010; Volume 33, Issue 12, eff. April 1, 2017; Volume 35, Issue 5, eff. December 13, 2018.

12VAC30-50-190 Dental services

A. Dental services shall be covered for individuals younger than 21 years of age in fulfillment of the treatment requirements under the Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) Program and defined as routine diagnostic, preventive, or restorative procedures necessary for oral health provided by or under the direct supervision of a dentist in accordance with Chapter 27 (§ 54.1-2700 et seq.) of Title 54.1 of the Code of Virginia.

1. The Department of Medical Assistance Services (DMAS) will provide any medically necessary dental service to individuals younger than 21 years of age.

2. Certain dental services, as described in the DMAS Office Reference Manual (Smiles for Children, March 13, 2014), prepared by DMAS's dental benefits administrator, require preauthorization or prepayment review by DMAS or its designee.

3. Dental services for individuals younger than the age of 21 years that do not require preauthorization or prepayment review are initial, periodic, and emergency examinations; required radiography necessary to develop a treatment plan; patient education; dental prophylaxis; fluoride treatments; routine amalgam and composite restorations; stainless steel crowns, prefabricated steel post and temporary (polycarbonate) crowns, and stainless steel bands; crown recementation; pulpotomies; emergency endodontics for temporary relief of pain; pulp capping; sedative fillings; therapeutic apical closure; topical palliative treatment for dental pain; removal of foreign body; simple extractions; root recovery; incision and drainage of abscess; surgical exposure of the tooth to aid eruption; sequestrectomy for osteomyelitis; and oral antral fistula closure.

B. Dental services determined by the dental provider to be medically appropriate for an adult woman during the term of her pregnancy and through the end of the month following the 60th day postpartum shall be provided to a Medicaid-enrolled pregnant woman. The dental services that shall be covered are (i) diagnostic x-rays and exams; (ii) preventive cleanings; (iii) restorative fillings; (iv) endodontics (root canals); (v) periodontics (gum-related treatments); (vi) prosthodontics, both removable and fixed (crowns, bridges, partial plates, and dentures); (vii) oral surgery (tooth extractions and other oral surgeries); and (viii) adjunctive general services (all covered services that do not fall into specific professional categories). These services require prepayment review by DMAS or its designee.

C. For the dental services covered for Medicaid-enrolled adult pregnant women, DMAS may place appropriate limits on a service based on medical necessity, for utilization control, or both. Examples of service limitations are examinations, prophylaxis, fluoride treatment (once/six months); space maintenance appliances; bitewing x-ray - two films (once/12 months); routine amalgam and composite restorations (once/three years); dentures (once/five years); extractions, tooth guidance appliances, permanent crowns and bridges, endodontics, patient education and sealants (once).

D. Limited oral surgery procedures, as defined and covered under Title XVIII (Medicare), are covered for all recipients, and require preauthorization or prepayment review by DMAS or its designee as described in the agency's Office Reference Manual located on the DMAS website at http://www.dmas.virginia.gov/#/dentalresources.

E. Residents of nursing facilities shall be permitted to deduct the costs of limited specific dental procedures from their payments toward the costs of their nursing facility care. Nursing facility residents shall be limited to deducting the following dental procedures: (i) routine exams and x-rays and dental cleaning twice yearly; (ii) full mouth x-rays once every three years; and (iii) extractions and fillings shall be permitted only if medically necessary as determined by DMAS.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-03-3.1100 § 10, eff. July 1, 1989; amended Virginia Register Volume 6, Issue 17, eff. July 1, 1990; amended, eff. January 1, 1992; amended, Volume 10, Issue 22, eff. September 1, 1994; Volume 12, Issue 3, eff. November 29, 1995; Volume 18, Issue 18, eff. July 1, 2002; Volume 22, Issue 23, eff. August 23, 2006; Volume 32, Issue 22, eff. July 27, 2016; Volume 34, Issue 26, eff. September 19, 2018.

12VAC30-50-200 Physical therapy, occupational therapy, and services for individuals with speech, hearing, and language disorders

A. Definitions. The following words and terms when used in this section shall have the following meanings unless the context clearly indicates otherwise:

"Acute conditions" means conditions that are expected to be of brief duration (less than 12 months) and in which progress toward established goals is likely to occur frequently.

"DMAS" means the Department of Medical Assistance Services.

"Evaluation" means a thorough assessment completed by a licensed therapist that is signed and fully dated and includes the following components: a medical diagnosis, clinical signs and symptoms, medical history, current functional status, summary of previous rehabilitative treatment and the result, and the therapist's recommendation for treatment.

"Nonacute conditions" means conditions that are of long duration (greater than 12 months) and in which progress toward established goals is likely to occur slowly.

"Physical rehabilitation services" means any medical or remedial services, as defined in 42 CFR 440.130, recommended by a physician or other licensed practitioner of the healing arts, within the scope of his practice under state law, for maximum reduction of physical or mental disability and restoration of an eligible individual to his best possible functional level.

"Plan of care" means a treatment plan developed by a licensed therapist, which shall include medical diagnosis; current functional status; individualized, measurable, participant-oriented goals (long-term and short-term goals) that describe the anticipated level of functional improvement; achievement timeframes for all goals; therapeutic interventions or treatments to be utilized by the therapist; frequency and duration of the therapies; and a discharge plan and anticipated discharge date.

"Reevaluation" means an assessment that contains all of the same components as an evaluation and that shall be completed when an individual has a significant change in his condition or when an individual is readmitted to a rehabilitative service.

"SLP" means speech-language pathology.

B. Amount, duration, and scope of outpatient rehabilitation therapy services. The application of a national standardized set of medical necessity criteria in use in the industry, such as McKesson InterQual^® Criteria or an equivalent standard authorized in advance by DMAS, shall be required for this service.

1. DMAS covers outpatient rehabilitation therapy services provided in outpatient settings of acute care and rehabilitation hospitals, nursing facilities, home health agencies, and rehabilitation agencies. All providers of outpatient rehabilitation therapy services shall have a current provider agreement with DMAS. All practitioners and providers of services shall be required to meet applicable state and federal licensing or certification requirements, or both.

2. Outpatient rehabilitation therapy evaluations or therapy treatment, or both, when rendered solely for vocational or educational purposes shall not be covered under the authority of this section. Developmental or behavioral assessments shall not be covered under the authority of this section. Individuals shall have a medical diagnosis, as determined by a licensed physician or other licensed practitioner of the healing arts within the scope of his practice under state law, and meet the medical necessity criteria in order to qualify for a Medicaid-covered outpatient rehabilitation therapy evaluation or therapy treatment, or both.

3. Outpatient rehabilitation services shall include physical therapy (PT), occupational therapy (OT), and speech-language pathology (SLP) services. These services shall be prescribed by a physician or a licensed practitioner of the healing arts within the scope of his practice under state law, such as a nurse practitioner or a physician assistant within the scope of his practice under state law, and be part of a written plan of care that is personally and legibly signed and dated by the licensed practitioner who ordered the services. Supervision for a licensed practitioner shall be provided by a physician as required by 18VAC90-30 and 18VAC90-40 for nurse practitioners and 18VAC85-50 for physician assistants. Any of these services may be offered as the sole rehabilitation service and is not contingent upon the provision of another service.

4. DMAS shall provide for the direct reimbursement to enrolled rehabilitation providers for covered outpatient rehabilitation therapy services when such services are rendered to individuals residing in nursing facilities. Such reimbursement shall not be provided for any sum that the rehabilitation provider collects, or is entitled to collect, from the nursing facility or any other available source, and provided further that the reimbursement shall in no way diminish any obligation of the nursing facility to DMAS to provide its residents such services as set forth in any applicable provider agreement.

5. The provision of physical therapy services shall meet all of the following conditions:

a. The services that the individual needs shall be directly and specifically related to a written plan of care developed, signed, and dated by a licensed physical therapist.

b. The services shall be of a level of complexity and sophistication or the condition of the individual shall be of a nature that the services can only be performed by a physical therapist licensed by the Virginia Board of Physical Therapy or a physical therapy assistant licensed by the Virginia Board of Physical Therapy and who is under the direct supervision of a licensed physical therapist.

c. When physical therapy services are provided by a qualified physical therapy assistant, such services shall be provided under the supervision of a qualified physical therapist who makes an onsite supervisory visit at least once every 30 days and documents the findings of the visit in the medical record. The supervisory visit shall not be reimbursable.

6. The provision of occupational therapy services shall meet all of the following conditions:

a. The services that the individual needs shall be directly and specifically related to a written plan of care developed, signed, and dated by a licensed occupational therapist.

b. The services shall be of a level of complexity and sophistication or the condition of the individual shall be of a nature that the services can only be performed by an occupational therapist certified by the National Board for Certification in Occupational Therapy and licensed by the Virginia Board of Medicine or an occupational therapy assistant certified by the National Board for Certification in Occupational Therapy who is under the direct supervision of a licensed occupational therapist.

c. When occupational therapy services are provided by a qualified occupational therapy assistant, such services shall be provided under the supervision of a qualified occupational therapist who makes an onsite supervisory visit at least once every 30 days and documents the visit findings in the medical record. The supervisory visit shall not be reimbursable.

7. The provision of speech-language pathology services shall meet all of the following conditions:

a. The services that the individual needs shall be directly and specifically related to a written plan of care developed, signed, and dated by a licensed speech-language pathologist.

b. The services shall be of a level of complexity and sophistication or the condition of the individual shall be of a nature that the services can only be performed by a speech-language pathologist licensed by the Virginia Board of Audiology and Speech-Language Pathology or who, if exempted from licensure by statute, meets the requirements in 42 CFR 440.110(c).

c. DMAS shall reimburse for the provision of speech-language pathology services when provided by a person considered by DMAS as a speech-language assistant (i.e., has a bachelor's level or a master's level degree without licensure by the Virginia Board of Audiology and Speech-Language Pathology and who does not meet the qualifications required for billing as a speech-language therapist). Speech-language assistants shall work under the direct supervision of a licensed professional therapist holding a Certificate of Clinical Competence (CCC) in SLP or a speech-language pathologist who meets the licensing requirements of the Virginia Board of Audiology and Speech-Language Pathology.

d. When services are provided by a therapist who is in his Clinical Fellowship Year (CFY) of an SLP Program or a speech-language assistant, a licensed professional therapist holding a CCC in SLP or a speech-language pathologist who shall make a supervisory visit at least every 30 days while therapy is being conducted and document the findings in the medical record. The supervisory visit shall not be reimbursable.

C. Authorization for outpatient rehabilitation services.

1. Physical therapy, occupational therapy, and speech-language pathology services provided in outpatient settings of acute and rehabilitation hospitals, rehabilitation agencies, nursing facilities, or home health agencies shall include authorization for up to five allowed visits, which do not require preceding service authorization, by each ordered rehabilitative service annually as long as the individual meets the medical necessity criteria as set out in subsection B of this section for the particular service. In situations when individuals require more than the initial five visits, providers shall submit to either DMAS or the service authorization contractor requests for service authorization and the required demonstration of medical necessity for such individuals. The provider shall maintain documentation to justify the need for services.

2. The provider shall request from DMAS or its contractor authorization for treatments deemed necessary by a physician or other licensed practitioner of the healing arts within the scope of his practice under state law beyond the initial five visits. Documentation for medical justification must include plans of care signed and dated by a physician or other licensed practitioner. Authorization for extended services shall be based on individual need. Payment shall not be made for additional services beyond the initial five visits unless the extended provision of services has been authorized by DMAS or its contractor.

3. Covered outpatient rehabilitative services for acute conditions shall include physical therapy, occupational therapy, and speech-language pathology services.

4. Covered outpatient rehabilitation services for long-term, nonacute conditions shall include physical therapy, occupational therapy, and speech-language pathology services.

5. Payment shall not be made for reimbursement requests submitted more than 12 months after the termination of services.

D. Service limitations. The following general conditions shall apply to reimbursable physical therapy, occupational therapy, and speech-language pathology services:

1. The individual must be under the care of a physician or other licensed practitioner who is legally authorized to practice and who is acting within the scope of his license.

2. The orders for evaluation of the need for therapy services shall identify the specific therapy discipline and must be personally signed and dated prior to the initiation of rehabilitative services.

3. The plan of care shall include the specific procedures and modalities to be used and indicate the frequency and duration for services. A written plan of care shall be reviewed by the physician or licensed practitioner every 60 days for acute conditions, as defined in subsection A of this section, or annually for nonacute conditions. The requested services shall be necessary to carry out the plan of care and shall be related to the individual's condition. The plan of care shall be signed and dated, as specified in this section, by the physician or other licensed practitioner who reviews the plan of care.

4. Quality management reviews, pursuant to 12VAC30-60-150, shall be performed by DMAS or its contractor.

5. Physical therapy, occupational therapy, and speech-language services are to be considered for termination regardless of the service authorized visits or services when any of the following conditions are met:

a. No further potential for improvement is demonstrated and the individual has reached his maximum progress.

b. Lack of participation on the part of the individual is evident.

c. The individual has an unstable condition that affects his ability to actively participate in a rehabilitative plan of care.

d. Progress toward an established goal or goals cannot be achieved within a reasonable period of time as determined by the licensed therapist.

e. The established goal serves no purpose to increase meaningful functional or cognitive capabilities.

f. The service no longer requires the skills of a qualified therapist.

g. A home maintenance program has been established to maintain the individual's function at the level to which it has been restored.

E. All providers of outpatient rehabilitation services shall be required to enroll as Medicaid providers using the outpatient rehabilitation services provider agreement.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-03-3.1100 § 11, eff. October 1, 1991; amended, eff. January 1, 1992; amended, eff. June 30, 1993; amended, Virginia Register Volume 11, Issue 17, eff. July 1, 1995; Volume 12, Issue 5, eff. December 27, 1995; Volume 14, Issue 18, eff. July 1, 1998; Volume 32, Issue 6, eff. January 1, 2016.

12VAC30-50-210 Prescribed drugs, dentures, and prosthetic devices, and eyeglasses prescribed by a physician skilled in diseases of the eye or by an optometrist

A. Prescribed drugs.

1. Drugs for which Federal Financial Participation is not available, pursuant to the requirements of § 1927 of the Social Security Act (OBRA 90 § 4401), shall not be covered.

2. Nonlegend drugs shall be covered by Medicaid in the following situations:

a. Insulin, syringes, and needles for diabetic patients;

b. Diabetic test strips for Medicaid recipients younger than 21 years of age;

c. Family planning supplies;

d. Designated categories of nonlegend drugs for Medicaid recipients in nursing homes;

e. Designated drugs prescribed by a licensed prescriber to be used as less expensive therapeutic alternatives to covered legend drugs; and

f. U.S. Environmental Protection Agency-registered insect repellents with one of the following active ingredients: DEET, picaridin, IR3535, oil of lemon eucalyptus, or p-Menthane-3,8-diol for all Medicaid members of reproductive age (ages 14 through 44 years) and all pregnant women, when prescribed by an authorized health professional.

3. Legend drugs are covered for a maximum of a 34-day supply per prescription per patient with the exception of the drugs or classes of drugs identified in 12VAC30-50-520. FDA-approved drug therapies and agents for weight loss, when preauthorized, will be covered for recipients who meet the strict disability standards for obesity established by the Social Security Administration in effect on April 7, 1999, and whose condition is certified as life threatening, consistent with Department of Medical Assistance Services' medical necessity requirements, by the treating physician. For prescription orders for which quantity exceeds a 34-day supply, refills may be dispensed in sufficient quantity to fulfill the prescription order within the limits of federal and state laws and regulations.

4. Prescriptions for Medicaid recipients for multiple source drugs subject to 42 CFR 447.332 shall be filled with generic drug products unless the physician or other practitioners so licensed and certified to prescribe drugs certifies in his own handwriting "brand necessary" for the prescription to be dispensed as written or unless the drug class is subject to the preferred drug list.

5. New drugs shall be covered in accordance with the Social Security Act § 1927(d) (OBRA 90 § 4401).

6. The number of refills shall be limited pursuant to § 54.1-3411 of the Drug Control Act.

7. Drug prior authorization.

a. Definitions. The following words and terms used in this section shall have the following meanings unless the context clearly indicates otherwise:

"Clinical data" means drug monographs as well as any pertinent clinical studies, including peer review literature.

"Complex drug regimen" means treatment or course of therapy that typically includes multiple medications, co-morbidities, or caregivers.

"Department" or "DMAS" means the Department of Medical Assistance Services.

"Drug" shall have the same meaning, unless the context otherwise dictates or the board otherwise provides by regulation, as provided in the Drug Control Act (§ 54.1-3400 et seq. of the Code of Virginia).

"Emergency supply" means 72-hour supplies of the prescribed medication that may be dispensed if the prescriber cannot readily obtain authorization, or if the physician is not available to consult with the pharmacist, including after hours, weekends, and holidays and the pharmacist, in his professional judgment consistent with current standards of practice, feels that the patient's health would be compromised without the benefit of the drug, or other criteria defined by the Pharmacy and Therapeutics Committee and DMAS.

"Nonpreferred drugs" means those drugs that were reviewed by the Pharmacy and Therapeutics Committee and not included on the preferred drug list. Nonpreferred drugs may be prescribed but require authorization prior to dispensing to the patient.

"Pharmacy and Therapeutics Committee," "P&T Committee" or "committee" means the committee formulated to review therapeutic classes, conduct clinical reviews of specific drugs, recommend additions or deletions to the preferred drug list, and perform other functions as required by the department.

"Preferred drug list" or "PDL" means the list of drugs that meet the safety, clinical efficacy, and pricing standards employed by the P&T Committee and adopted by the department for the Virginia Medicaid fee-for-service program. Most drugs on the PDL may be prescribed and dispensed in the Virginia Medicaid fee-for-service program without prior authorization; however, some drugs as recommended by the Pharmacy and Therapeutics Committee may require authorization prior to dispensing to the patient.

"Prior authorization," as it relates to the PDL, means the process of review by a clinical pharmacist of legend drugs that are not on the preferred drug list, or other drugs as recommended by the Pharmacy and Therapeutics Committee, to determine if medically justified.

"State supplemental rebate" means any cash rebate that offsets Virginia Medicaid expenditure and that supplements the federal rebate. State supplemental rebate amounts shall be calculated in accordance with the Virginia Supplemental Drug Rebate Agreement Contract and Addenda.

"Therapeutic class" means a grouping of medications sharing the same Specific Therapeutic Class Code (GC3) within the Federal Drug Data File published by First Data Bank, Inc.

"Utilization review" means the prospective and retrospective processes employed by the agency to evaluate the medical necessity of reimbursing for certain covered services.

b. Medicaid Pharmacy and Therapeutics Committee.

(1) The department shall utilize a Pharmacy and Therapeutics Committee to assist in the development and ongoing administration of the preferred drug list and other pharmacy program issues. The committee may adopt bylaws that set out its make-up and functioning. A quorum for action of the committee shall consist of seven members.

(2) Vacancies on the committee shall be filled in the same manner as original appointments. DMAS shall appoint individuals for the committee that assures a cross-section of the physician and pharmacy community and remains compliant with General Assembly membership guidelines.

(3) Duties of the committee. The committee shall receive and review clinical and pricing data related to the drug classes. The committee's medical and pharmacy experts shall make recommendations to DMAS regarding various aspects of the pharmacy program. For the preferred drug list program, the committee shall select those drugs to be deemed preferred that are safe, clinically effective, as supported by available clinical data, and meet pricing standards. Cost effectiveness or any pricing standard shall be considered only after a drug is determined to be safe and clinically effective.

(4) As the U.S. Food and Drug Administration (FDA) approves new drug products, the department shall ensure that the Pharmacy and Therapeutics Committee will evaluate the drug for clinical effectiveness and safety. Based on clinical information and pricing standards, the P&T Committee will determine if the drug will be included in the PDL or require prior authorization.

(a) If the new drug product falls within a drug class previously reviewed by the P&T Committee, until the review of the new drug is completed, it will be classified as nonpreferred, requiring prior authorization in order to be dispensed. The new drug will be evaluated for inclusion in the PDL no later than at the next review of the drug class.

(b) If the new drug product does not fall within a drug class previously reviewed by the P&T Committee, the new drug shall be treated in the same manner as the other drugs in its class.

(5) To the extent feasible, the Pharmacy and Therapeutics Committee shall review all drug classes included in the preferred drug list at least every 12 months and may recommend additions to and deletions from the PDL.

(6) In formulating its recommendations to the department, the committee shall not be deemed to be formulating regulations for the purposes of the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

(7) Immunity. The members of the committee, the staff of the department, and the contractor shall be immune, individually and jointly, from civil liability for any act, decision, or omission done or made in performance of their duties pursuant to this subsection while serving as a member of such board, committee, or staff provided that such act, decision, or omission is not done or made in bad faith or with malicious intent.

c. Pharmacy prior authorization program. Pursuant to § 1927 of the Act and 42 CFR 440.230, the department shall require the prior authorization of certain specified legend drugs. For those therapeutic classes of drugs subject to the PDL program, drugs with nonpreferred status included in the DMAS drug list shall be subject to prior authorization. The department also may require prior authorization of other drugs only if recommended by the P&T Committee. Providers who are licensed to prescribe legend drugs shall be required to obtain prior authorization for all nonpreferred drugs or other drugs as recommended by the P&T Committee.

(1) Prior authorization shall consist of prescription review by a licensed pharmacist or pharmacy technician to ensure that all predetermined clinically appropriate criteria, as established by the P&T Committee relative to each therapeutic class, have been met before the prescription may be dispensed. Prior authorization shall be obtained through a call center staffed with appropriate clinicians, or through written or electronic communications (e.g., faxes, mail). Responses by telephone or other telecommunications device within 24 hours of a request for prior authorization shall be provided. The dispensing of 72-hour emergency supplies of the prescribed drug may be permitted and dispensing fees shall be paid to the pharmacy for such emergency supply.

(2) The preferred drug list program shall include (i) provisions for an expedited review process of denials of requested prior authorization by the department; (ii) consumer and provider education; and (iii) training and information regarding the preferred drug list both prior to implementation as well as ongoing communications, to include computer and website access to information and multilingual material.

(3) Exclusion of protected groups from the pharmacy preferred drug list prior authorization requirements. The following groups of Medicaid eligibles shall be excluded from pharmacy prior authorization requirements: individuals enrolled in hospice care, services through PACE or pre-PACE programs; persons having comprehensive third party insurance coverage; minor children who are the responsibility of the juvenile justice system; and refugees who are not otherwise eligible in a Medicaid covered group.

d. Supplemental rebates. The department has the authority to seek supplemental rebates from pharmaceutical manufacturers. In addition to collecting supplemental rebates for fee-for-service claims, the department may, at its option, also collect supplemental rebates for Medicaid member utilization through MCOs under an agreement. Supplemental rebate agreements shall be separate from the federal rebates and in compliance with federal law, §§ 1927(a)(1) and 1927(a)(4) of the Social Security Act. All rebates collected on behalf of the Commonwealth shall be collected for the sole benefit of the state share of costs.

e. Pursuant to 42 USC § 1396r-8(b)(3)(D), information disclosed to the department or to the committee by a pharmaceutical manufacturer or wholesaler which discloses the identity of a specific manufacturer or wholesaler and the pricing information regarding the drugs by such manufacturer or wholesaler is confidential and shall not be subject to the disclosure requirements of the Virginia Freedom of Information Act (§ 2.2-3700 et seq. of the Code of Virginia).

f. Appeals for denials of prior authorization shall be addressed pursuant to 12VAC30-110, Part I, Client Appeals.

8. Coverage of home infusion therapy. This service shall be covered consistent with the limits and requirements set out within home health services (12VAC30-50-160). Multiple applications of the same therapy (e.g., two antibiotics on the same day) shall be covered under one service day rate of reimbursement. Multiple applications of different therapies (e.g., chemotherapy, hydration, and pain management on the same day) shall be a full service day rate methodology as provided in pharmacy services reimbursement.

B. Dentures. Dentures are provided only as a result of EPSDT and subject to medical necessity and preauthorization requirements specified under Dental Services.

C. Prosthetic devices.

1. Prosthetic services shall mean the replacement of missing arms, legs, eyes, and breasts and the provision of any internal (implant) body part. Nothing in this regulation shall be construed to refer to orthotic services or devices or organ transplantation services.

2. Artificial arms and legs, and their necessary supportive attachments, implants and breasts are provided when prescribed by a physician or other licensed practitioner of the healing arts within the scope of their professional licenses as defined by state law. This service, when provided by an authorized vendor, must be medically necessary and preauthorized for the minimum applicable component necessary for the activities of daily living.

3. Eye prostheses are provided when eyeballs are missing regardless of the age of the recipient or the cause of the loss of the eyeball. Eye prostheses are provided regardless of the function of the eye.

D. Eyeglasses. Eyeglasses shall be reimbursed for all recipients younger than 21 years of age according to medical necessity when provided by practitioners as licensed under the Code of Virginia.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-03-3.1100 § 12, eff. July 1, 1992; amended, Virginia Register Volume 9, Issue 11, eff. April 1, 1993; Volume 9, Issue 18, eff. July 1, 1993; Volume 12, Issue 3, eff. November 29, 1995; Volume 13, Issue 7, eff. February 1, 1997; Volume 13, Issue 13, eff. April 16, 1997; Volume 13, Issue 18, eff. July 1, 1997; Volume 15, Issue 5, eff. January 1, 1999; Volume 15, Issue 23, eff. September 1, 1999; Volume 16, Issue 2, eff. November 10, 1999; Volume 18, Issue 4, eff. December 5, 2001; Volume 18, Issue 18, eff. July 1, 2002; Volume 21, Issue 6, eff. January 3, 2005; Volume 30, Issue 7, eff. January 16, 2014; Volume 33, Issue 19, eff. June 29, 2017; Volume 35, Issue 12, eff. March 21, 2019; Volume 37, Issue 13, eff. April 4, 2021.

12VAC30-50-220 Diagnostic, screening, preventive, and rehabilitative services other than those provided elsewhere in this plan

A. Diagnostic services are provided but only when necessary to confirm a diagnosis.

B. Preventive services.

1. Screening PSA (i.e., prostate specific antigen) and the related DRE (i.e., digital rectal examination) for males shall be covered, consistent with the guidelines of the American Cancer Society.

2. Maternity length of stay and early discharge.

a. If the mother and newborn, or the newborn alone, are discharged earlier than 48 hours after the day of delivery, DMAS will cover one early discharge follow-up visit. The mother and newborn, or the newborn alone if the mother has not been discharged, must meet the criteria for early discharge to be eligible for the early discharge follow-up visit. This early discharge follow-up visit does not affect or apply to any usual postpartum or well-baby care or any other covered care to which the mother or newborn is entitled; it is tied directly to an early discharge.

b. The early discharge follow-up visit must be provided as directed by a physician. The physician may coordinate with the provider of the physician's choice to provide the early discharge follow-up visit, within the following limitations. Qualified providers are those hospitals, physicians, nurse midwives, nurse practitioners, federally qualified health clinics, rural health clinics, and health department clinics that are enrolled as Medicaid providers and are qualified by the appropriate state authority for delivery of the service. The staff providing the follow-up visit, at a minimum, must be a registered nurse having training and experience in maternal and child health. The visit must be provided within 48 hours of discharge.

3. Any clinical preventive services that are assigned a grade of A or B by the United States Preventive Services Task Force (USPSTF) along with approved vaccines and vaccine administration recommended by the Advisory Committee on Immunization Practices (ACIP) for adult, full-Medicaid individuals.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-03-3.1100 § 13, eff. July 1, 1992; amended, eff. June 29, 1993; Virginia Register Volume 11, Issue 17, eff. July 1, 1995; Volume 12, Issue 3, eff. November 29, 1995; Volume 12, Issue 18, eff. July 1, 1996; Volume 13, Issue 1, eff. November 1, 1996; Volume 14, Issue 7, eff. January 22, 1998; Volume 14, Issue 18, eff. July 1, 1998; Volume 15, Issue 25, eff. October 1, 1999; Volume 16, Issue 18, eff. July 1, 2000; Volume 34, Issue 8, eff. January 10, 2018; Volume 41, Issue 26, eff. September 25, 2025.

12VAC30-50-225 Rehabilitative services; intensive physical rehabilitation, and CORF services

A. Definitions. The following words and terms when used in this section shall have the following meanings unless the context clearly indicates otherwise:

"Actively participate" means the individual regularly, as may be ordered by the physician, attends planned therapeutic activities and demonstrates progress towards goals established in the plan of care.

"Admission certification statement" means that the physician signs and dates an initial written statement in the individual's medical record of the need for intensive rehabilitation services. This statement shall be documented at the time of the rehabilitation admission.

"Comprehensive outpatient rehabilitation facility" or "CORF" means a facility that offers a coordinated intensive rehabilitation day program that uses an interdisciplinary team approach and includes, at a minimum, physicians' services and rehabilitation nursing in addition to at least two of the following four therapy services: (i) physical therapy, (ii) occupational therapy, (iii) cognitive rehabilitation therapy, or (iv) speech-language pathology.

"Licensed practitioner of the healing arts" means either a nurse practitioner, a physician assistant, or other practitioner as licensed by the Commonwealth to render covered services.

"Physical rehabilitation services" means medically prescribed treatments for improving or restoring functions that have been impaired by illness or injury, or where function has been permanently lost or reduced by illness or injury, for improving the individual's ability to perform those tasks required for independent functioning.

"Plan of care" means a written order signed and dated by a physician or other licensed practitioner that is specific to the individual that includes orders for rehabilitation therapies, including the frequency and duration of services; required medications; treatments; diet; and other services as needed, for example, psychological services, social work services, or therapeutic recreation services.

"Recertification" means that the physician or other licensed practitioner shall sign and date at least every 60 days a written statement in the individual's medical record of the continuing need for intensive rehabilitation services.

"Therapist plan of care" means a written treatment plan, developed by each licensed therapist involved with the individual's care, to include measurable long-term and short-term goals, interventions or modalities, frequency and duration, and a discharge disposition. These therapist plans of care shall be written, signed, and dated by either a licensed physical or occupational therapist, speech-language pathologist, cognitive rehabilitative therapist, psychologist, social worker, or certified therapeutic recreational specialist.

B. Medicaid covers intensive inpatient physical rehabilitation services in facilities certified as physical rehabilitation hospitals or physical rehabilitation units in acute care hospitals.

C. Medicaid covers intensive outpatient physical rehabilitation services in facilities that are certified as comprehensive outpatient rehabilitation facilities (CORFs). With the exception of the physician admission certification statement, all of the service criteria for intensive rehabilitation services also apply to CORFs.

D. The application of a national standardized set of medical necessity criteria in use in the industry, such as McKesson InterQual^® Criteria or an equivalent standard authorized in advance by DMAS, shall be required for this service. In addition, an individual qualifies for intensive inpatient rehabilitation or comprehensive outpatient physical rehabilitation as provided in a CORF if all of the following criteria are met:

1. Adequate treatment of the individual's medical condition requires an intensive physical rehabilitation program consisting of an interdisciplinary coordinated team approach to improve his ability to function as independently as possible.

2. It has been established that the rehabilitation program cannot be safely and adequately carried out in a less intensive setting.

3. In addition to the medical condition requirement, individuals shall meet the following criteria in order to be eligible for intensive inpatient rehabilitation or comprehensive outpatient physical rehabilitation provided in a CORF:

a. The individual shall require at least two of these four therapies in addition to requiring rehabilitative skilled nursing:

(1) Occupational therapy;

(2) Physical therapy;

(3) Cognitive rehabilitation therapy; or

(4) Speech-language pathology services.

b. The individual's medical condition shall be stable and compatible with an active rehabilitation program.

4. The individual shall (i) have a rehabilitation potential such that the individual's condition can be expected, based on the physician's assessment, to improve significantly in a reasonable and generally predictable period of time or (ii) require rehabilitation services as necessary toward the establishment of a safe and effective home maintenance therapy program required in connection with a specific diagnosis.

E. Within 24 hours of an individual's admission to intensive physical rehabilitation services, all of the physician requirements of 12VAC30-60-120 A shall be met.

F. An intensive physical rehabilitation program provides medically necessary intensive skilled rehabilitation nursing, physical therapy, occupational therapy, and, if needed, speech-language pathology, cognitive rehabilitation, prosthetic-orthotic services, psychology, social work, and therapeutic recreation services. With the exception of CORF services, the physician or other licensed practitioner shall be responsible for admission and discharge orders. If verbal orders are given, written plans of care shall be signed and dated within 72 hours of the verbal order. The nursing staff shall support the other disciplines in carrying out the individual's interdisciplinary plan of care treatment activities on the medical nursing unit and furnishing other needed nursing services. The individual interdisciplinary plan of care must be carried out under the continuing direct supervision of a physician or other licensed practitioner with special training or experience in the field of physical medicine and rehabilitation. For CORF services, only physicians shall be permitted to initiate plans of care or orders.

1. For an individual with a potential for physical rehabilitation for which an outpatient assessment cannot be adequately performed, an admission to intensive inpatient rehabilitation for an evaluation of no more than seven calendar days in duration shall be allowed. During this admission, a comprehensive rehabilitation evaluation shall be made of (i) the individual's medical condition, functional limitations, prognosis, possible need for corrective surgery, and ability to participate in rehabilitation and (ii) the existence of any social problems affecting rehabilitation. After these evaluations have been made, the physician, in consultation with the interdisciplinary rehabilitation team, shall determine and justify the level of care required to achieve the stated goals.

2. If during a previous hospital admission the individual completed a rehabilitation program for essentially the same condition for which inpatient hospital rehabilitation care is now being considered, reimbursement for the evaluation shall not be covered unless there is a documented intervening circumstance, such as an injury or serious illness, that necessitates a reevaluation.

3. Admissions for evaluation or training, or both, for solely vocational or educational purposes or for developmental or behavioral assessments shall not be covered services under the authority of this section.

G. All providers of rehabilitation services shall be enrolled as a Medicaid provider. Inpatient rehabilitation providers and CORFS shall enroll via the Rehabilitation Hospital Participation Agreement, and Comprehensive Outpatient Rehab Facility Participation Agreement, respectively.

H. To receive continued intensive rehabilitation services, the individual must demonstrate an ability to actively participate in goal-related therapeutic interventions developed by the interdisciplinary team. This shall be evidenced by regular attendance in planned therapy activities and demonstrated progress toward the established goals.

I. Intensive rehabilitation services shall be considered for termination regardless of the service authorized length of stay when one or more of the following conditions are met:

1. No further potential for improvement is demonstrated and the individual has reached his maximum progress;

2. Lack of participation on the part of the individual is evident;

3. An unstable condition affects the individual's ability to actively participate, as defined in subsection A of this section, in a rehabilitative plan of care;

4. Progress toward an established goal or goals cannot be achieved within a reasonable period of time as determined by the licensed therapist;

5. The established goal serves no purpose to increase meaningful functional or cognitive capabilities;

6. The service no longer requires the skills of a qualified therapist; or

7. A home maintenance program has been established to maintain the individual's function to the level to which it has been restored.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 14, Issue 7, eff. January 22, 1998; amended, Virginia Register Volume 32, Issue 6, eff. January 1, 2016.

12VAC30-50-226 Community mental health services

A. Definitions. The following words and terms when used in this section shall have the following meanings unless the context clearly indicates otherwise:

"Activities of daily living" or "ADLs" means personal care tasks such as bathing, dressing, toileting, transferring, and eating or feeding. An individual's degree of independence in performing these activities is a part of determining appropriate level of care and service needs.

"Affiliated" means any entity or property in which a provider or facility has a direct or indirect ownership interest of 5.0% or more, or any management, partnership, or control of an entity.

"Certified prescreener" means an employee of either the local community services board or behavioral health authority or its designee who is skilled in the assessment and treatment of mental illness and who has completed a certification program approved by DBHDS.

"Certified prescreener assessment" means an assessment for crisis intervention and crisis stabilization completed by a certified prescreener that meets the elements of a comprehensive needs assessment.

"Code" means the Code of Virginia.

"Comprehensive needs assessment" means the same as defined in 12VAC30-50-130 and also includes individuals who are older than 21 years of age. Requirements for the comprehensive needs assessment are set out in 12VAC30-60-143.

"DBHDS" means the Department of Behavioral Health and Developmental Services consistent with Chapter 3 (§ 37.2-300 et seq.) of Title 37.2 of the Code of Virginia.

"Direct supervisor" means the person who provides direct supervision to the peer recovery specialist. The direct supervisor (i) shall have two consecutive years of documented practical experience rendering peer support services or family support services, have certification training as a PRS under a certifying body approved by DBHDS, and have documented completion of the DBHDS PRS supervisor training; (ii) shall be a qualified mental health professional (QMHP-A, QMHP-C, or QMHP-E) as defined in 12VAC35-105-20 with at least two consecutive years of documented experience as a QMHP, and who has documented completion of the DBHDS PRS supervisor training; or (iii) shall be an LMHP, LMHP-R, LMHP-RP, or LMHP-S who has documented completion of the DBHDS PRS supervisor training who is acting within his scope of practice under state law. An LMHP, LMHP-R, LMHP-RP, or LMHP-S providing services before April 1, 2018, shall have until April 1, 2018, to complete the DBHDS PRS supervisor training.

"DMAS" means the Department of Medical Assistance Services and its contractor consistent with Chapter 10 (§ 32.1-323 et seq.) of Title 32.1 of the Code of Virginia.

"DSM-5" means the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, copyright 2013, American Psychiatric Association.

"Individual" means the patient, client, or recipient of services described in this section.

"Individual service plan" or "ISP" means a comprehensive and regularly updated treatment plan specific to the individual's unique treatment needs as identified in the comprehensive needs assessment. The ISP contains, but is not limited to, the individual's treatment or training needs, the individual's goals and measurable objectives to meet the identified needs, services to be provided with the recommended frequency to accomplish the measurable goals and objectives, the estimated timetable for achieving the goals and objectives, and an individualized discharge plan that describes transition to other appropriate services. The individual shall be included in the development of the ISP and the ISP shall be signed by the individual. If the individual is a minor child, the ISP shall also be signed by the individual's parent or legal guardian. Documentation shall be provided if the individual, who is a minor child or an adult who lacks legal capacity, is unable or unwilling to sign the ISP.

"Individualized training" means instruction and practice in functional skills and appropriate behavior related to the individual's health and safety, instrumental activities of daily living skills, and use of community resources; assistance with medical management; and monitoring health, nutrition, and physical condition. The training shall be rehabilitative and based on a variety of incremental (or cumulative) approaches or tools to organize and guide the individual's life planning and shall reflect what is important to the individual in addition to all other factors that affect the individual's functioning, including effects of the disability and issues of health and safety.

"Licensed mental health professional" or "LMHP" means the same as defined in 12VAC35-105-20.

"LMHP-resident" or "LMHP-R" means the same as "resident" as defined in (i) 18VAC115-20-10 for licensed professional counselors; (ii) 18VAC115-50-10 for licensed marriage and family therapists; or (iii) 18VAC115-60-10 for licensed substance abuse treatment practitioners. An LMHP-resident shall be in continuous compliance with the regulatory requirements of the applicable counseling profession for supervised practice and shall not perform the functions of the LMHP-R or be considered a "resident" until the supervision for specific clinical duties at a specific site has been preapproved in writing by the Virginia Board of Counseling.

"LMHP-resident in psychology" or "LMHP-RP" means the same as an individual in a residency, as that term is defined in 18VAC125-20-10, program for clinical psychologists. An LMHP-resident in psychology shall be in continuous compliance with the regulatory requirements for supervised experience as found in 18VAC125-20-65 and shall not perform the functions of the LMHP-RP or be considered a "resident" until the supervision for specific clinical duties at a specific site has been preapproved in writing by the Virginia Board of Psychology.

"LMHP-supervisee in social work," "LMHP-supervisee," or "LMHP-S" means the same as "supervisee" is defined in 18VAC140-20-10 for licensed clinical social workers. An LMHP-supervisee in social work shall be in continuous compliance with the regulatory requirements for supervised practice as found in 18VAC140-20-50 and shall not perform the functions of the LMHP-S or be considered a "supervisee" until the supervision for specific clinical duties at a specific site is preapproved in writing by the Virginia Board of Social Work.

"Peer recovery specialist" or "PRS" means the same as defined in 12VAC35-250-10.

"Peer recovery support services" means the same as defined in 12VAC35-250-10.

"Person centered" means the same as defined in 12VAC30-130-5160.

"Qualified mental health professional-adult" or "QMHP-A" means the same as defined in § 54.1-3500 of the Code.

"Qualified mental health professional-child" or "QMHP-C" means the same as defined in § 54.1-3500 of the Code.

"Qualified mental health professional-eligible" or "QMHP-E" means the same as the term "qualified mental health professional – trainee" as defined in § 54.1-3500 of the Code.

"Qualified paraprofessional in mental health" or "QPPMH" means the same as defined in 12VAC35-105-20.

"Recovery-oriented services" means the same as defined in 12VAC30-130-5160.

"Recovery, resiliency, and wellness plan" means the same as defined in 12VAC30-130-5160.

"Register" or "registration" means notifying DMAS or its contractor that an individual will be receiving services that do not require service authorization.

"Resiliency" means the same as defined in 12VAC30-130-5160.

"Self-advocacy" means the same as defined in 12VAC30-130-5160.

"Service authorization" means the process to approve specific services for an enrolled Medicaid, FAMIS Plus, or FAMIS individual by a DMAS service authorization contractor prior to service delivery and reimbursement in order to validate that the service requested is medically necessary and meets DMAS and DMAS contractor criteria for reimbursement. Service authorization does not guarantee payment for the service.

"Strength-based" means the same as defined in 12VAC30-130-5160.

"Supervision" means the same as defined in 12VAC30-130-5160.

B. Mental health services. The following services, with their definitions, shall be covered: day treatment/partial hospitalization, psychosocial rehabilitation, crisis services, intensive community treatment (ICT), and mental health skill building. Staff travel time shall not be included in billable time for reimbursement. These services, in order to be covered, shall meet medical necessity criteria based upon diagnoses made by an LMHP, LMHP-R, LMHP-RP, or LMHP-S who is practicing within the scope of their license and that are reflected in provider records and on providers' claims for services by recognized diagnosis codes that support and are consistent with the requested professional services. These services are intended to be delivered in a person-centered manner. The individuals who are receiving these services shall be included in all service planning activities. All services which do not require service authorization require registration. This registration shall transmit service-specific information to DMAS or its contractor in accordance with service authorization requirements.

1. Day treatment/partial hospitalization services shall be provided in sessions of two or more consecutive hours per day, which may be scheduled multiple times per week, to groups of individuals in a nonresidential setting. These services include the major diagnostic, medical, psychiatric, psychosocial, and psychoeducational treatment modalities designed for individuals who require coordinated, intensive, comprehensive, and multidisciplinary treatment but who do not require inpatient treatment. One unit of service shall be defined as a minimum of two but less than four hours on a given day. Two units of service shall be defined as at least four but less than seven hours in a given day. Three units of service shall be defined as seven or more hours in a given day. Authorization is required for Medicaid reimbursement.

a. Day treatment/partial hospitalization services shall be time limited interventions that are more intensive than outpatient services and are required to stabilize an individual's psychiatric condition. The services are delivered when the individual is at risk of psychiatric hospitalization or is transitioning from a psychiatric hospitalization to the community. The comprehensive needs assessment shall document the individual's behavior and describe how the individual is at risk of psychiatric hospitalization or is transitioning from a psychiatric hospitalization to the community.

b. Individuals qualifying for this service must demonstrate a clinical necessity for the service arising from mental, behavioral, or emotional illness that results in significant functional impairments in major life activities. Individuals must meet at least two of the following criteria on a continuing or intermittent basis:

(1) Experience difficulty in establishing or maintaining normal interpersonal relationships to such a degree that they are at risk of hospitalization or homelessness or isolation from social supports;

(2) Experience difficulty in activities of daily living such as maintaining personal hygiene, preparing food and maintaining adequate nutrition, or managing finances to such a degree that health or safety is jeopardized;

(3) Exhibit such inappropriate behavior that the individual requires repeated interventions or monitoring by the mental health, social services, or judicial system that have been documented; or

(4) Exhibit difficulty in cognitive ability such that they are unable to recognize personal danger or recognize significantly inappropriate social behavior.

c. Individuals shall be discharged from this service when they are no longer in an acute psychiatric state and other less intensive services may achieve psychiatric stabilization.

d. Admission and services for time periods longer than 90 calendar days must be authorized based upon a face-to-face evaluation by an LMHP, LMHP-R, LMHP-RP, or LMHP-S.

e. These services may only be rendered by an LMHP, LMHP-supervisee, LMHP-resident, LMHP-RP, QMHP-A, QMHP-C, QMHP-E, or a QPPMH.

2. Psychosocial rehabilitation shall be provided at least two or more hours per day to groups of individuals in a nonresidential setting. These services include assessment, education to teach the patient about the diagnosed mental illness and appropriate medications to avoid complication and relapse, and opportunities to learn and use independent living skills and to enhance social and interpersonal skills within a supportive and normalizing program structure and environment. One unit of service is defined as a minimum of two but less than four hours on a given day. Two units are defined as at least four but less than seven hours in a given day. Three units of service shall be defined as seven or more hours in a given day. Authorization is required for Medicaid reimbursement. The comprehensive needs assessment shall document the individual's behavior and describe how the individual meets criteria for this service.

a. Individuals qualifying for this service must demonstrate a clinical necessity for the service arising from mental, behavioral, or emotional illness that results in significant functional impairments in major life activities. Services are provided to individuals (i) who without these services would be unable to remain in the community or (ii) who meet at least two of the following criteria on a continuing or intermittent basis:

(1) Experience difficulty in establishing or maintaining normal interpersonal relationships to such a degree that they are at risk of psychiatric hospitalization, homelessness, or isolation from social supports;

(2) Experience difficulty in activities of daily living such as maintaining personal hygiene, preparing food and maintaining adequate nutrition, or managing finances to such a degree that health or safety is jeopardized;

(3) Exhibit such inappropriate behavior that repeated interventions documented by the mental health, social services, or judicial system are or have been necessary; or

(4) Exhibit difficulty in cognitive ability such that they are unable to recognize personal danger or significantly inappropriate social behavior.

b. These services may only be rendered by an LMHP, LMHP-supervisee, LMHP-resident, LMHP-RP, a QMHP-A, a QMHP-C, a QMHP-E, or a QPPMH.

3. Crisis intervention shall provide immediate mental health care, available 24 hours a day, seven days per week, to assist individuals who are experiencing acute psychiatric dysfunction requiring immediate clinical attention. This service's objectives shall be to prevent exacerbation of a condition, to prevent injury to the client or others, and to provide treatment in the context of the least restrictive setting. Crisis intervention activities shall include assessing the crisis situation, providing short-term counseling designed to stabilize the individual, providing access to further immediate assessment and follow-up, and linking the individual and family with ongoing care to prevent future crises. Crisis intervention services may include office visits, home visits, preadmission screenings, telephone contacts, and other client-related activities for the prevention of institutionalization. The comprehensive needs assessment or certified prescreener assessment shall document the individual's behavior and describe how the individual meets criteria for this service. The provision of this service to an individual shall be registered with DMAS within one business day of the completion of the comprehensive needs assessment or certified prescreener assessment to avoid duplication of services and to ensure informed care coordination.

a. Individuals qualifying for this service must demonstrate a clinical necessity for the service arising from an acute crisis of a psychiatric nature that puts the individual at risk of psychiatric hospitalization. Individuals must meet at least two of the following criteria at the time of admission to the service:

(1) Experience difficulty in establishing or maintaining normal interpersonal relationships to such a degree that they are at risk of psychiatric hospitalization, homelessness, or isolation from social supports;

(2) Experience difficulty in activities of daily living such as maintaining personal hygiene, preparing food and maintaining adequate nutrition, or managing finances to such a degree that health or safety is jeopardized;

(3) Exhibit such inappropriate behavior that immediate interventions documented by mental health, social services, or the judicial system are or have been necessary; or

(4) Exhibit difficulty in cognitive ability such that they are unable to recognize personal danger or significantly inappropriate social behavior.

b. A unit shall equal 15 minutes.

c. These services may only be rendered by an LMHP, an LMHP-supervisee, LMHP-resident, LMHP-RP, or a certified prescreener.

4. Intensive community treatment (ICT) shall be provided based on a written comprehensive needs assessment and certification of need by an LMHP, LMHP-S, LMHP-R, or LMHP-RP and shall include medical psychotherapy, psychiatric assessment, medication management, and care coordination activities offered to outpatients outside the clinic, hospital, or office setting for individuals who are best served in the community. Authorization is required for Medicaid reimbursement.

a. To qualify for ICT, the individual must meet at least one of the following criteria:

(1) The individual must be at high risk for psychiatric hospitalization or becoming or remaining homeless due to mental illness or require intervention by the mental health or criminal justice system due to inappropriate social behavior.

(2) The individual has a history (three months or more) of a need for intensive mental health treatment or treatment for co-occurring serious mental illness and substance use disorder and demonstrates a resistance to seek out and utilize appropriate treatment options.

b. A written comprehensive needs assessment that documents the individual's eligibility and the need for this service must be completed prior to the initiation of services. This comprehensive needs assessment must be maintained in the individual's records.

c. An individual service plan shall be initiated at the time of admission and must be fully developed, as defined in this section, within 30 days of the initiation of services.

d. A unit shall equal one hour.

e. These services may only be rendered by a team that meets the requirements of 12VAC35-105-1370.

f. ICT services shall be reviewed by an LMHP, LMHP-R, LMHP-RP, or LMHP-S for all individuals who have received at least six months of ICT to determine the continued need for this service.

5. Crisis stabilization services for nonhospitalized individuals shall provide direct mental health care to individuals experiencing an acute psychiatric crisis which may jeopardize their current community living situation. Services shall be provided following a face-to-face comprehensive needs assessment by an LMHP, LMHP-supervisee, LMHP-resident, or LMHP-RP or a certified prescreener assessment. The provision of this service to an individual shall be registered with DMAS within one business day of the initiation of services to avoid duplication of services and to ensure informed care coordination.

a. The goals of crisis stabilization programs shall be to avert hospitalization or rehospitalization, provide normative environments with a high assurance of safety and security for crisis intervention, stabilize individuals in psychiatric crisis, and mobilize the resources of the community support system and family members and others for on-going maintenance and rehabilitation. The services must be documented in the individual's records as having been provided consistent with the ISP in order to receive Medicaid reimbursement.

b. The crisis stabilization program shall provide to individuals, as appropriate, psychiatric assessment including medication evaluation, treatment planning, symptom and behavior management, and individual and group counseling.

c. This service may be provided in any of the following settings, but shall not be limited to: (i) the home of an individual who lives with family or other primary caregiver; (ii) the home of an individual who lives independently; or (iii) community-based programs licensed by DBHDS to provide residential services but which are not institutions for mental disease (IMDs).

d. This service shall not be reimbursed for (i) individuals with medical conditions that require hospital care; (ii) individuals with a primary diagnosis of substance abuse; or (iii) individuals with psychiatric conditions that cannot be managed in the community (i.e., individuals who are of imminent danger to themselves or others).

e. Services must be documented through daily progress notes and a daily log of times spent in the delivery of services. The comprehensive needs assessment or certified prescreener assessment shall document the individual's behavior and describe how the individual meets criteria for this service. Individuals qualifying for this service must demonstrate a clinical necessity for the service arising from an acute crisis of a psychiatric nature that puts the individual at risk of psychiatric hospitalization. Individuals must meet at least two of the following criteria at the time of admission to the service:

(1) Experience difficulty in establishing and maintaining normal interpersonal relationships to such a degree that the individual is at risk of psychiatric hospitalization, homelessness, or isolation from social supports;

(2) Experience difficulty in activities of daily living such as maintaining personal hygiene, preparing food and maintaining adequate nutrition, or managing finances to such a degree that health or safety is jeopardized;

(3) Exhibit such inappropriate behavior that immediate interventions documented by the mental health, social services, or judicial system are or have been necessary; or

(4) Exhibit difficulty in cognitive ability such that the individual is unable to recognize personal danger or significantly inappropriate social behavior.

f. These services may only be rendered by an LMHP, LMHP-supervisee, LMHP-resident, LMHP-RP, a QMHP-A, a QMHP-C, a QMHP-E, or a certified prescreener.

6. Mental health skill-building services (MHSS) shall be defined as goal-directed training to enable individuals to achieve and maintain community stability and independence in the most appropriate, least restrictive environment. Authorization is required for Medicaid reimbursement. Services that are rendered before the date of service authorization shall not be reimbursed. These services may be authorized up to six consecutive months as long as the individual meets the coverage criteria for this service. The comprehensive needs assessment shall document the individual's behavior and describe how the individual meets criteria for this service. These services shall provide goal-directed training in the following areas in order to be reimbursed by Medicaid or the DMAS contractor: (i) functional skills and appropriate behavior related to the individual's health and safety, instrumental activities of daily living, and use of community resources; (ii) assistance with medication management; and (iii) monitoring of health, nutrition, and physical condition with goals towards self-monitoring and self-regulation of all of these activities. Providers shall be reimbursed only for training activities defined in the ISP and only where services meet the service definition, eligibility, and service provision criteria and this section. A review of MHSS services by an LMHP, LMHP-R, LMHP-RP, or LMHP-S shall be repeated for all individuals who have received at least six months of MHSS to determine the continued need for this service.

a. Individuals qualifying for this service shall demonstrate a clinical necessity for the service arising from a condition due to mental, behavioral, or emotional illness that results in significant functional impairments in major life activities. Services are provided to individuals who require individualized goal-directed training in order to achieve or maintain stability and independence in the community.

b. Individuals 21 years of age and older shall meet all of the following criteria in order to be eligible to receive mental health skill-building services:

(1) The individual shall have one of the following as a primary mental health diagnosis:

(a) Schizophrenia or other psychotic disorder as set out in the DSM-5;

(b) Major depressive disorder;

(c) Recurrent Bipolar I or Bipolar II; or

(d) Any other serious mental health disorder that a physician has documented specific to the identified individual within the past year and that includes all of the following: (i) is a serious mental illness; (ii) results in severe and recurrent disability; (iii) produces functional limitations in the individual's major life activities that are documented in the individual's medical record; and (iv) requires individualized training for the individual in order to achieve or maintain independent living in the community.

(2) The individual shall require individualized goal-directed training in order to acquire or maintain self-regulation of basic living skills, such as symptom management; adherence to psychiatric and physical health medication treatment plans; appropriate use of social skills and personal support systems; skills to manage personal hygiene, food preparation, and the maintenance of personal adequate nutrition; money management; and use of community resources.

(3) The individual shall have a prior history of any of the following: (i) psychiatric hospitalization; (ii) either residential or nonresidential crisis stabilization; (iii) intensive community treatment (ICT) or program of assertive community treatment (PACT) services; (iv) placement in a psychiatric residential treatment facility (PRTF) as a result of decompensation related to the individual's serious mental illness; or (v) a temporary detention order (TDO) evaluation, pursuant to § 37.2-809 B of the Code of Virginia. This criterion shall be met in order to be initially admitted to services and not for subsequent authorizations of service. Discharge summaries from prior providers that clearly indicate (i) the type of treatment provided, (ii) the dates of the treatment previously provided, and (iii) the name of the treatment provider shall be sufficient to meet this requirement. Family member statements shall not suffice to meet this requirement.

(4) The individual shall have had a prescription for antipsychotic, mood stabilizing, or antidepressant medications within the 12 months prior to the comprehensive needs assessment date. If a physician or other practitioner who is authorized by his license to prescribe medications indicates that antipsychotic, mood stabilizing, or antidepressant medications are medically contraindicated for the individual, the provider shall obtain medical records signed by the physician or other licensed prescriber detailing the contraindication. This documentation shall be maintained in the individual's mental health skill-building services record, and the provider shall document and describe how the individual will be able to actively participate in and benefit from services without the assistance of medication. This criterion shall be met upon admission to services and shall not be required for subsequent authorizations of service. Discharge summaries from prior providers that clearly indicate (i) the type of treatment provided, (ii) the dates of the treatment previously provided, and (iii) the name of the treatment provider shall be sufficient to meet this requirement. Family member statements shall not suffice to meet this requirement.

c. Individuals 18, 19, and 20 years of age shall meet all of the following criteria in order to be eligible to receive mental health skill-building services:

(1) The individual shall not be living in a supervised setting as described in § 63.2-905.1 of the Code of Virginia. If the individual is transitioning into an independent living situation, MHSS shall only be authorized for up to six months prior to the date of transition.

(2) The individual shall have at least one of the following as a primary mental health diagnosis:

(a) Schizophrenia or other psychotic disorder as set out in the DSM-5;

(b) Major depressive disorder;

(c) Recurrent Bipolar I or Bipolar II; or

(d) Any other serious mental health disorder that a physician has documented specific to the identified individual within the past year and that includes all of the following: (i) is a serious mental illness or serious emotional disturbance; (ii) results in severe and recurrent disability; (iii) produces functional limitations in the individual's major life activities that are documented in the individual's medical record; and (iv) requires individualized training for the individual in order to achieve or maintain independent living in the community.

(3) The individual shall require individualized goal-directed training in order to acquire or maintain self-regulation of basic living skills such as symptom management; adherence to psychiatric and physical health medication treatment plans; appropriate use of social skills and personal support systems; skills to manage personal hygiene, food preparation, and the maintenance of personal adequate nutrition; money management; and use of community resources.

(4) The individual shall have a prior history of any of the following: (i) psychiatric hospitalization; (ii) either residential or nonresidential crisis stabilization; (iii) intensive community treatment (ICT) or program of assertive community treatment (PACT) services; (iv) placement in a psychiatric residential treatment facility as a result of decompensation related to the individual's serious mental illness; or (v) temporary detention order (TDO) evaluation pursuant to § 37.2-809 B of the Code of Virginia. This criterion shall be met in order to be initially admitted to services and not for subsequent authorizations of service. Discharge summaries from prior providers that clearly indicate (i) the type of treatment provided, (ii) the dates of the treatment previously provided, and (iii) the name of the treatment provider shall be sufficient to meet this requirement. Family member statements shall not suffice to meet this requirement.

(5) The individual shall have had a prescription for antipsychotic, mood stabilizing, or antidepressant medications, within the 12 months prior to the assessment date. If a physician or other practitioner who is authorized by his license to prescribe medications indicates that antipsychotic, mood stabilizing, or antidepressant medications are medically contraindicated for the individual, the provider shall obtain medical records signed by the physician or other licensed prescriber detailing the contraindication. This documentation of medication management shall be maintained in the individual's mental health skill-building services record. For individuals not prescribed antipsychotic, mood stabilizing, or antidepressant medications, the provider shall have documentation from the medication management physician describing how the individual will be able to actively participate in and benefit from services without the assistance of medication. This criterion shall be met in order to be initially admitted to services and not for subsequent authorizations of service. Discharge summaries from prior providers that clearly indicate (i) the type of treatment provided, (ii) the dates of the treatment previously provided, and (iii) the name of the treatment provider shall be sufficient to meet this requirement. Family member statements shall not suffice to meet this requirement.

d. Comprehensive needs assessments shall be required at the onset of services and individual service plans (ISPs) shall be required during the entire duration of services. Services based upon incomplete, missing, or outdated comprehensive needs assessment or ISPs shall be denied reimbursement. Requirements for comprehensive needs assessments and ISPs are set out in 12VAC30-60-143.

e. Only direct face-to-face contacts and services to the individual shall be reimbursable. One unit is 1 to 2.99 hours per day, and two units is 3 or more hours per day.

f. These services may only be rendered by an LMHP, LMHP-R, LMHP-RP, LMHP-S, a QMHP-A, a QMHP-C, a QMHP-E, or a QPPMH.

g. The provider shall clearly document details of the services provided during the entire amount of time billed.

h. The ISP shall not include activities that contradict or duplicate those in the treatment plan established by the therapeutic group home or assisted living facility. The provider shall coordinate mental health skill-building services with the treatment plan established by the group home or assisted living facility and shall document all coordination activities in the medical record.

i. Limits and exclusions.

(1) Therapeutic group home and assisted living facility providers shall not serve as the mental health skill-building services provider for individuals residing in the provider's respective facility. Individuals residing in facilities may, however, receive MHSS from another MHSS agency not affiliated with the owner of the facility in which they reside.

(2) Mental health skill-building services shall not be reimbursed for individuals who are receiving in-home residential services or congregate residential services through the Intellectual Disability Waiver or Individual and Family Developmental Disabilities Support Waiver.

(3) Mental health skill-building services shall not be reimbursed for individuals who are also receiving services under the Department of Social Services independent living program (22VAC40-151), independent living services (22VAC40-131 and 22VAC40-151), or independent living arrangement (22VAC40-131) or any Comprehensive Services Act-funded independent living skills programs.

(4) Mental health skill-building services shall not be available to individuals who are receiving treatment foster care (12VAC30-130-900 et seq.).

(5) Mental health skill-building services shall not be available to individuals who reside in intermediate care facilities for individuals with intellectual disabilities or hospitals.

(6) Mental health skill-building services shall not be available to individuals who reside in nursing facilities, except for up to 60 days prior to discharge. If the individual has not been discharged from the nursing facility during the 60-day period of services, mental health skill-building services shall be terminated and no further service authorizations shall be available to the individual unless a provider can demonstrate and document that mental health skill-building services are necessary. Such documentation shall include facts demonstrating a change in the individual's circumstances and a new plan for discharge requiring up to 60 days of mental health skill-building services.

(7) Mental health skill-building services shall not be available for residents of psychiatric residential treatment centers except for the comprehensive needs assessment code H0032 (modifier U8) in the seven days immediately prior to discharge.

(8) Mental health skill-building services shall not be reimbursed if personal care services or attendant care services are being received simultaneously, unless justification is provided why this is necessary in the individual's mental health skill-building services record. Medical record documentation shall fully substantiate the need for services when personal care or attendant care services are being provided. This applies to individuals who are receiving additional services through the Intellectual Disability Waiver (12VAC30-120-1000 et seq.), Individual and Family Developmental Disabilities Support Waiver (12VAC30-120-700 et seq.), the Elderly or Disabled with Consumer Direction Waiver (12VAC30-120-900 et seq.), and EPSDT services (12VAC30-50-130).

(9) Mental health skill-building services shall not be duplicative of other services. Providers shall be required to ensure that if an individual is receiving additional therapeutic services that there will be coordination of services by either the LMHP, LMHP-R, LMHP-RP, LMHP-S, QMHP-A, QMHP-C, QMHP-E, or QPPMH to avoid duplication of services.

(10) Individuals who have organic disorders, such as delirium, dementia, or other cognitive disorders not elsewhere classified, will be prohibited from receiving mental health skill-building services unless their physicians issue signed and dated statements indicating that the individuals can benefit from this service.

(11) Individuals who are not diagnosed with a serious mental health disorder but who have personality disorders or other mental health disorders, or both, that may lead to chronic disability shall not be excluded from the mental health skill-building services eligibility criteria provided that the individual has a primary mental health diagnosis from the list included in subdivision B 6 b (1) or B 6 c (2) of this section and that the provider can document and describe how the individual is expected to actively participate in and benefit from mental health skill-building services.

7. Mental health peer support services.

a. Mental health peer support services are peer recovery support services and are nonclinical, peer-to-peer activities that engage, educate, and support an individual's self-help efforts to improve health recovery, resiliency, and wellness. Mental health peer support services for adults is a person centered, strength-based, and recovery-oriented rehabilitative service for individuals 21 years of age or older provided by a peer recovery specialist successful in the recovery process with lived experience with a mental health disorder, who is trained to offer support and assistance in helping others in the recovery to reduce the disabling effects of a mental health disorder that is the focus of support. Services assist the individual with developing and maintaining a path to recovery, resiliency, and wellness. Specific peer support service activities shall emphasize the acquisition, development, and enhancement of recovery, resiliency, and wellness. Services are designed to promote empowerment, self-determination, understanding, and coping skills through mentoring and service coordination supports, as well as to assist individuals in achieving positive coping mechanisms for the stressors and barriers encountered when recovering from their illnesses or disorders.

b. Under the clinical oversight of the LMHP, LMHP-R, LMHP-RP, or LMHP-S assessing the individual and making the recommendation for mental health support services, the peer recovery specialist in consultation with his direct supervisor shall develop a recovery, resiliency, and wellness plan based on the recommendation of the LMHP, LMHP-R, LMHP-RP, or LMHP-S for service, the individual's perceived recovery needs, and any clinical assessments or comprehensive needs assessments as defined in this section within 30 calendar days of the initiation of service. Development of the recovery, resiliency, and wellness plan shall include collaboration with the individual. Individualized goals and strategies shall be focused on the individual's identified needs for self-advocacy and recovery. The recovery, resiliency, and wellness plan shall also include documentation of how many days per week and how many hours per week are required to carry out the services in order to meet the goals of the plan. The recovery, resiliency, and wellness plan shall be completed, signed, and dated by (i) the LMHP, LMHP-R, LMHP-RP, or LMHP-S; (ii) the PRS; (iii) the direct supervisor; and (iv) the individual within 30 calendar days of the initiation of service. The PRS shall act as an advocate for the individual, encouraging the individual to take a proactive role in developing and updating goals and objectives in the individualized recovery planning.

c. Documentation of required activities shall be required as set forth in 12VAC30-130-5200 C and E through J.

d. Limitations and exclusions to service delivery shall be the same as set forth in 12VAC30-130-5210.

e. Individuals 21 years of age or older qualifying for mental health peer support services shall meet the following requirements:

(1) Require recovery-oriented assistance and support services for the acquisition of skills needed to engage in and maintain recovery; for the development of self-advocacy skills to achieve a decreasing dependency on formalized treatment systems; and to increase responsibilities, wellness potential, and shared accountability for the individual's own recovery.

(2) Have a documented mental health disorder diagnosis.

(3) Demonstrate moderate to severe functional impairment because of a diagnosis that interferes with or limits performance in at least one of the following domains: educational (e.g., obtaining a high school or college degree); social (e.g., developing a social support system); vocational (e.g., obtaining part-time or full-time employment); self-maintenance (e.g., managing symptoms, understanding his illness, living more independently).

f. To qualify for continued mental health peer support services, medical necessity criteria shall continue to be met, and progress notes shall document the status of progress relative to the goals identified in the recovery, resiliency, and wellness plan.

g. Discharge criteria from mental health peer support services is the same as set forth in 12VAC30-130-5180 E.

h. Mental health peer support services shall be rendered on an individual basis or in a group.

i. Prior to service initiation, an assessment shall be conducted and documented by an LMHP, LMHP-R, LMHP-RP, or LMHP-S within the scope of practice under state law. The assessment shall verify that the individual meets the medical necessity criteria set forth in subdivision 7 e of this subsection. The assessment shall be included as part of the recovery, resiliency, and wellness plan and medical record. Services shall be initiated within 30 calendar days from when the assessment was complete.

j. Effective July 1, 2017, a peer recovery specialist shall have the qualifications, education, experience, and certification established by DBHDS in accordance with 12VAC35-250. Peer Recovery Specialists shall be registered with the Virginia Board of Counseling. The PRS shall perform mental health peer support services under the oversight of the LMHP, LMHP-R, LMHP-RP, or LMHP-S who shall provide the clinical oversight of the recovery, resiliency, and wellness plan. The PRS shall be employed by or have a contractual relationship with an enrolled provider licensed for one of the following:

(1) Acute care general hospital licensed by the Department of Health.

(2) Freestanding psychiatric hospital and inpatient psychiatric unit licensed by the Department of Behavioral Health and Developmental Services.

(3) Outpatient mental health clinic services licensed by the Department of Behavioral Health and Developmental Services.

(4) Outpatient psychiatric services provider.

(5) Rural health clinics and federally qualified health centers.

(6) Hospital emergency department services licensed by the Department of Health.

(7) Community mental health and rehabilitative services provider licensed by the Department of Behavioral Health and Developmental Services as a provider of one of the following community mental health and rehabilitative services defined in this section or 12VAC30-50-420 for which the individual meets medical necessity criteria:

(a) Day treatment or partial hospitalization;

(b) Psychosocial rehabilitation;

(c) Crisis intervention;

(d) Intensive community treatment;

(e) Crisis stabilization;

(f) Mental health skill building; or

(g) Mental health case management.

k. Only the licensed and enrolled provider referenced in subdivision 7 j of this subsection shall be eligible to bill mental health peer support services. Payments shall not be permitted to providers that fail to enter into an enrollment agreement with DMAS or its contractor. Reimbursement shall be subject to retraction for any billed service that is determined to not to be in compliance with DMAS requirements.

l. Supervision of the PRS shall be required as set forth in the definition of "supervision" in 12VAC30-130-5160. Supervision of the PRS shall also meet the following requirements: the direct supervisor shall perform direct supervision of the PRS as needed based on the level of urgency and intensity of service being provided. The direct supervisor shall have an employment or contract relationship with the same provider entity that employs or contracts with the PRS. Direct supervisors shall maintain documentation of all supervisory sessions. In no instance shall supervisory sessions be performed less than as provided in subdivisions 7 l (1) and 7 l (2) of this subsection:

(1) If the PRS has less than 12 months of experience delivering peer support services or family support partners, the PRS shall receive face-to-face, one-to-one supervisory meetings of sufficient length to address identified challenges for a minimum of a 30-minute session, two times a month. The direct supervisor must be available at least by telephone while the PRS is on duty.

(2) If the PRS has been delivering peer support services or family support partners for over 12 months and fewer than 24 months, the PRS must receive monthly face-to-face, one-to-one supervision of sufficient length to address identified challenges for a minimum of 30 minutes. The direct supervisor must be available by telephone for consult within 24 hours of service delivery if needed.

m. The supervisor shall be under the clinical oversight of the LMHP, LMHP-R, LMHP-RP, or LMHP-S who assessed the individual and made the recommendation for services, and the peer recovery specialist in consultation with his direct supervisor shall conduct and document a review of the recovery, resiliency, and wellness plan every 90 calendar days with the individual and the caregiver, as applicable. The review shall be signed by the PRS and the individual and, as applicable, the identified family member or caregiver. Review of the recovery, resiliency, and wellness plan means the PRS evaluates and updates the individual's progress every 90 calendar days toward meeting the plan's goals and documents the outcome of this review in the individual's medical record. For DMAS to determine that these reviews are complete, the reviews shall (i) update the goals and objectives as needed to reflect any change in the individual's recovery as well as any newly identified needs, (ii) be conducted in a manner that enables the individual to actively participate in the process, and (iii) be documented by the PRS in the individual's medical record no later than 15 calendar days from the date of the review.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 14, Issue 7, eff. January 22, 1998; amended, Virginia Register Volume 20, Issue 7, eff. February 1, 2004; Volume 27, Issue 10, eff. February 16, 2011; Volume 31, Issue 9, eff. January 30, 2015; Volume 32, Issue 22, eff. July 27, 2016; Volume 34, Issue 3, eff. November 16, 2017; Volume 35, Issue 10, eff. February 21, 2019; Volume 35, Issue 24, eff. August 22, 2019; Volume 37, Issue 14, eff. April 14, 2021; Volume 38, Issue 12, eff. March 17, 2022.

12VAC30-50-227 Lead contamination

Coverage shall be provided for investigations by local health departments to determine the source of lead contamination in the home as part of the management and treatment of Medicaid-eligible children who have been diagnosed with elevated blood lead levels. Only costs that are eligible for federal funding participation in accordance with current federal regulations shall be covered. Payments for environmental investigations under this section shall be limited to no more than two visits per residence.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 14, Issue 7, eff. January 22, 1998.

12VAC30-50-228 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 26, Issue 8, eff. January 21, 2010; repealed, Virginia Register Volume 33, Issue 12, eff. April 1, 2017.

12VAC30-50-229 [Reserved]. (Reserved)

12VAC30-50-229.1 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 14, Issue 18, eff. July 1, 1998; amended, Virginia Register Volume 15, Issue 17, eff. June 9, 1999; Errata, 15:18 VA.R. 2411 May 24, 1999; amended, Virginia Register Volume 17, Issue 5, eff. January 1, 2001; Volume 18, Issue 7, eff. January 16, 2002; repealed, Virginia Register Volume 25, Issue 5, eff. December 10, 2008.

12VAC30-50-230 Services for individuals age 65 or older in institutions for mental diseases

A. Inpatient hospital services are provided with no limitations.

B. Skilled nursing facility services are provided with no limitations.

C. Intermediate care facility services are provided with no limitations.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-03-3.1100 § 14, eff. October 1, 1990; amended, eff. July 1, 1991; Virginia Register Volume 10, Issue 22, eff. September 1, 1994; Volume 12, Issue 3, eff. November 29, 1995.

12VAC30-50-240 Intermediate care services and intermediate care services for institutions for mental disease and intellectual disabilities

A. Intermediate care facility services (other than such services in an institution for mental diseases) for persons determined, in accordance with § 1902 (a)(31)(A) of the Act, to be in need of such care are provided with no limitations.

B. Including such services in a public institution (or distinct part thereof) for individuals with developmental disabilities or persons with related conditions are provided with no limitations.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-03-3.1100 § 15, eff. July 1, 1991; amended, Virginia Register Volume 10, Issue 22, eff. September 1, 1994; Volume 12, Issue 3, eff. November 29, 1995; Volume 42, Issue 11, eff. February 11, 2026.

12VAC30-50-250 Inpatient psychiatric facility services for individuals under 21 years of age

Inpatient psychiatric facility services for individuals under 21 years of age are not provided, other than those provided under early and periodic screening, diagnosis, and treatment (12VAC30-50-130).

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-03-3.1100 § 16, eff. July 1, 1991; amended, Virginia Register Volume 10, Issue 22, eff. September 1, 1994; Volume 12, Issue 3, eff. November 29, 1995; Volume 17, Issue 5, eff. January 1, 2001.

12VAC30-50-260 Nurse-midwife services

Covered services for nurse midwives are defined as those services allowed under the licensure requirements of the state statute and as specified in 42 CFR 440.165.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-03-3.1100 § 17, eff. July 1, 1991; amended, Virginia Register Volume 10, Issue 22, eff. September 1, 1994; Volume 12, Issue 3, eff. November 29, 1995; Volume 18, Issue 7, eff. January 16, 2002.

12VAC30-50-270 Hospice services (in accordance with § 1905 (o) of the Act)

A. Covered hospice services shall be defined as those services allowed under the provisions of Medicare law and regulations as they relate to hospice benefits and as specified in 42 CFR Part 418.

B. Categories of care. As described for Medicare and applicable to Medicaid, hospice services shall entail the following four categories of daily care:

1. Routine home care is at-home care that is not continuous.

2. Continuous home care consists of at-home care that is predominantly nursing care and is provided as short-term crisis care. A registered or licensed practical nurse must provide care for more than half of the period of the care. Home health aide or homemaker services may be provided in addition to nursing care. A minimum of eight hours of care per day must be provided to qualify as continuous home care.

3. Inpatient respite care is short-term inpatient care provided in an approved facility (freestanding hospice, hospital, or nursing facility) to relieve the primary caregiver or caregivers providing at-home care for the recipient. Respite care is limited to not more than five consecutive days.

4. General inpatient care may be provided in an approved freestanding hospice, hospital, or nursing facility. This care is usually for pain control or acute or chronic symptom management which cannot be successfully treated in another setting.

C. Covered services.

1. As required under Medicare and applicable to Medicaid, the hospice itself shall provide all or substantially all of the "core" services applicable for the terminal illness which are nursing care, social work, and counseling (bereavement, dietary, and spiritual).

2. Other services applicable for the terminal illness that shall be available but are not considered "core" services are physician services, drugs and biologicals, home health aide and homemaker services, inpatient care, medical supplies, and occupational and physical therapies and speech-language/pathology services, and any other item or service which is specified under the plan and which is reasonable and necessary for the palliation and management of terminal illness and for which payment may otherwise be made under Title XIX.

3. These other services may be arranged, such as by contractual agreement, or provided directly by the hospice.

4. To be covered, a certification that the individual is terminally ill shall have been completed by the physician, or physicians as required by 12VAC30-60-130 D, and hospice services must be reasonable and necessary for the palliation or management of the terminal illness and related conditions. The individual must elect hospice care and a plan of care must be established before services are provided. To be covered, services shall be consistent with the plan of care. Services not specifically documented in the patient's medical record as having been rendered will be deemed not to have been rendered and no coverage will be provided.

5. All services shall be performed by appropriately qualified personnel, but it is the nature of the service, rather than the qualification of the person who provides it, that determines the coverage category of the service. The following services are covered hospice services:

a. Nursing care. Nursing care shall be provided by a registered nurse or by a licensed practical nurse under the supervision of a graduate of an approved school of professional nursing and who is licensed as a registered nurse.

b. Medical social services. Medical social services shall be provided by a social worker who has at least a bachelor's degree from a school accredited or approved by the Council on Social Work Education, and who is working under the direction of a physician.

c. Physician services. Physician services shall be performed by a professional who is licensed to practice, who is acting within the scope of his or her license, and who is a doctor of medicine or osteopathy, a doctor of dental surgery or dental medicine, a doctor of podiatric medicine, a doctor of optometry, or a chiropractor. The hospice medical director or the physician member of the interdisciplinary team shall be a licensed doctor of medicine or osteopathy.

d. Counseling services. Counseling services shall be provided to the terminally ill individual and the family members or other persons caring for the individual at home. Bereavement counseling consists of counseling services provided to the individual's family up to one year after the individual's death. Bereavement counseling is a required hospice service, but it is not reimbursable.

e. Short-term inpatient care. Short-term inpatient care may be provided in a participating hospice inpatient unit, or a participating hospital or nursing facility. General inpatient care may be required for procedures necessary for pain control or acute or chronic symptom management which cannot be provided in other settings. Inpatient care may also be furnished to provide respite for the individual's family or other persons caring for the individual at home.

f. Durable medical equipment and supplies. Durable medical equipment as well as other self-help and personal comfort items related to the palliation or management of the patient's terminal illness is covered. Medical supplies include those that are part of the written plan of care.

g. Drugs and biologicals. Only drugs used which are used primarily for the relief of pain and symptom control related to the individual's terminal illness are covered.

h. Home health aide and homemaker services. Home health aides providing services to hospice recipients must meet the qualifications specified for home health aides by Medicare and the Department of Health Professions. Home health aides may provide personal care services. Aides may also perform household services to maintain a safe and sanitary environment in areas of the home used by the recipient, such as changing the bed or light cleaning and laundering essential to the comfort and cleanliness of the recipient. Homemaker services may include assistance in personal care, maintenance of a safe and healthy environment and services to enable the individual to carry out the plan of care. Home health aide and homemaker services must be provided under the general supervision of a registered nurse.

i. Rehabilitation services. Rehabilitation services include physical and occupational therapies and speech-language pathology services that are used for purposes of symptom control or to enable the individual to maintain activities of daily living and basic functional skills.

D. Eligible groups. To be eligible for hospice coverage under Medicare or Medicaid, the recipient must have a life expectancy of six months or less, have knowledge of the illness and life expectancy, and except for individuals under 21 years of age, elect to receive hospice services rather than active treatment for the illness. Both the attending physician and the hospice medical director, or the attending physician and the physician member of the interdisciplinary team, must initially certify the life expectancy. Thereafter, subsequent certifications shall be conducted pursuant to 12VAC30-60-130.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-03-3.1100 § 18, eff. July 1, 1991; amended, Virginia Register Volume 10, Issue 22, eff. September 1, 1994; Volume 16, Issue 6, eff. January 5, 2000; Volume 27, Issue 3, eff. November 10, 2010.

12VAC30-50-280 Case management services for high-risk pregnant women and children up to age 1, as defined in 12VAC30-50-410, in accordance with § 1915 (g)(1) of ...

Case management services for high-risk pregnant women and children up to age 1 are provided, with limitations. See 12VAC30-50-410 for details.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-03-3.1100 § 19, eff. July 1, 1991; amended, Virginia Register Volume 10, Issue 22, eff. September 1, 1994; Volume 12, Issue 3, eff. November 29, 1995.

12VAC30-50-290 Extended services to pregnant women

A. Pregnancy-related and postpartum services for 60 days after the pregnancy ends. The same limitations on all covered services apply to this group as to all other recipient groups.

B. Services for any other medical conditions that may complicate pregnancy. The same limitations on all covered services apply to this group as to all other recipient groups.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-03-3.1100 § 20, eff. October 1, 1987; amended, eff. January 1, 1993; amended, Virginia Register Volume 10, Issue 22, eff. September 1, 1994.

12VAC30-50-300 Any other medical care and any other type of remedial care recognized under state law, specified by the Secretary of Health and Human Services

A. Emergency transportation services shall be provided to Virginia Medicaid recipients to ensure that they have necessary access to and from providers of all emergency medical services. Emergency transport services shall be covered and nonemergency transport services shall be covered as medical services. The single state agency may enter into contracts with friends of recipients, public agencies, nonprofit private agencies, for-profit private agencies, and public carriers to provide transportation to Medicaid recipients.

B. Services of Christian Science nurses are not provided.

C. Care and services provided in Christian Science sanitoria are provided with no limitations.

D. Skilled nursing facility services for patients under 21 years of age are provided with no limitations.

E. Emergency hospital services are provided with no limitations.

F. Personal care services in recipient's home, prescribed in accordance with a plan of treatment and provided by a qualified person under supervision of a registered nurse are not provided.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-03-3.1100 § 21, eff. October 1, 1987; amended, Virginia Register Volume 9, Issue 4, eff. January 1, 1993; Volume 10, Issue 22, eff. September 1, 1994; Volume 12, Issue 3, eff. November 29, 1995; Volume 17, Issue 12, eff. July 2, 2001; Volume 21, Issue 22, eff. August 10, 2005.

12VAC30-50-310 Emergency services for aliens

A. No payment shall be made for medical assistance furnished to qualified aliens who entered the United States on or after August 22, 1996, who are not eligible for Medicaid for five years after their entry, and nonqualified aliens, including illegal aliens and legal nonimmigrants who are otherwise eligible, unless such services are necessary for the treatment of an emergency medical condition of the alien.

B. Emergency services are defined as:

Emergency treatment of accidental injury or medical condition (including emergency labor and delivery) manifested by acute symptoms of sufficient severity (including severe pain) such that the absence of immediate medical/surgical attention could reasonably be expected to result in:

1. Placing the patient's health in serious jeopardy;

2. Serious impairment of bodily functions; or

3. Serious dysfunction of any bodily organ or part.

For purposes of this definition, emergency treatment of a medical condition does not include care and services related to either an organ transplant procedure or routing prenatal or postpartum care.

C. Medicaid eligibility and reimbursement is conditional upon review of necessary documentation supporting the need for emergency services. Services and inpatient lengths of stay cannot exceed the limits established for other Medicaid recipients.

D. Claims for conditions which do not meet emergency criteria for treatment in an emergency room or for acute care hospital admissions for intensity of service or severity of illness will be denied reimbursement by the Department of Medical Assistance Services.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-03-3.1100 § 22, eff. June 29, 1994; amended, Virginia Register Volume 10, Issue 22, eff. September 1, 1994; Volume 13, Issue 18, eff. July 1, 1997.

12VAC30-50-320 Program of All-Inclusive Care for the Elderly (PACE)

The Commonwealth of Virginia has entered into a valid program agreement or agreements with a PACE provider or providers and the Secretary of the U.S. Department of Health and Human Services.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 18, eff. July 1, 2000; amended, Virginia Register Volume 23, Issue 16, eff. July 1, 2007; Volume 25, Issue 8, eff. February 5, 2009.

12VAC30-50-321 Eligibility for PACE enrollees

A. The Commonwealth determines eligibility for PACE enrollees under rules applying to institutional groups, and applies posteligibility treatment of income rules to those individuals as specified in subsection B of this section. The posteligibility treatment of income rules specified in this section are the same as those that apply to the Commonwealth's approved Home and Community Based Services waivers.

B. Regular Post Eligibility. As a 209(b) state, the Commonwealth is using more restrictive eligibility requirements than those for Supplemental Security Income (SSI). The Commonwealth is using the posteligibility rules at 42 CFR 435.735. Payment for PACE services is reduced by the amount remaining after deducting the following amounts from the PACE enrollee's income.

1. 42 CFR 435.735: States using more restrictive requirements than SSI.

a. Allowances for the needs of the individual shall be 165% of SSI.

b. Allowance for the needs of the spouse shall not apply.

c. Allowance for the needs of the family shall be the medically needy income standard.

2. Medical and remedial care expenses shall be as specified in 42 CFR 435.735.

C. Spousal Post Eligibility. The Commonwealth uses the posteligibility rules of § 1924 of the Social Security Act (the Act) (spousal impoverishment protection) to determine the individual's contribution toward the cost of PACE services if it determines the individual's eligibility under § 1924 of the Act. There shall be deducted from the individual's monthly income a personal needs allowance (165% of SSI as specified below), and a community spouse's allowance, a family allowance, and an amount for incurred expenses for medical or remedial care, as specified in the State Medicaid plan. Allowances for the needs of the individual shall be 165% of SSI.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 16, eff. July 1, 2007.

12VAC30-50-325 Rates and payments

A. The Commonwealth assures that the capitated rates will be less than the cost to the agency of providing State Plan approved services to an equivalent nonenrolled population group.

B. To determine the amount that would otherwise have been paid (AWOP) under the State Plan for a comparable population, the Commonwealth uses base period encounter data adjusted for comparable populations and services to those provided by the Program of All-Inclusive Care for the Elderly (PACE) program, specifically individuals 55 years of age or older who historically receive services in an institutional setting or enrolled in a home and community-based services (HCBS) § 1915(c) waiver. The historical data is adjusted to reflect modifications of payment arrangements between the data period and the contract period as well as benefit or eligibility changes that occurred prior to the beginning of the contract period. The base period data is also updated to reflect expected increases in utilization and cost for the contract period covered by the rates. An allowance for administrative costs is added to the AWOPs along with a provision for underwriting gain.

C. The final capitation rates are determined as a percentage discount off of the amount that would otherwise have been paid for these populations.

D. The PACE capitation rates vary by region and by eligibility status (dual-eligible and non-dual-eligible).

E. The Commonwealth assures that the rates were set in a reasonable and predictable manner.

F. The Commonwealth will submit all capitated rates to the Centers for Medicare and Medicaid Services (CMS) regional office for prior approval.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 16, eff. July 1, 2007; amended, Virginia Register Volume 41, Issue 1, eff. October 10, 2024.

12VAC30-50-328 PACE enrollment and disenrollment

The Commonwealth assures that there is a process in place to provide for dissemination of PACE enrollment and disenrollment data. The Commonwealth assures that it has developed and will implement procedures for the enrollment and disenrollment of PACE participants via the Virginia Medicaid Enterprise System (MES), including procedures for any adjustment to account for the difference between the estimated number of PACE participants on which the prospective monthly payment was based and the actual number of PACE participants in that month.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 16, eff. July 1, 2007; amended, Virginia Register Volume 42, Issue 20, eff. June 17, 2026.

12VAC30-50-330 PACE definitions

For purposes of this part and all contracts establishing the Program of All-Inclusive Care for the Elderly (PACE) programs as defined in 42 CFR Part 460, the following definitions shall apply:

"Adult day health care center" or "ADHC" means a DMAS-enrolled provider that offers a community-based day program providing a variety of health, therapeutic, and social services designed to meet the specialized needs of those elderly and disabled individuals at risk of placement in a nursing facility.

"Applicant" means an individual seeking enrollment in a PACE plan.

"Capitation rate" means the negotiated Medicaid monthly per capita amount paid to a PACE provider for all services provided to enrollees.

"Catchment area" means the designated service area for a PACE plan.

"Centers for Medicare and Medicaid Services" or "CMS" means the unit of the U.S. Department of Health and Human Services that administers the Medicare and Medicaid programs.

"CFR" means the Code of Federal Regulations.

"Direct marketing" means either (i) conducting directly or indirectly door-to-door, telephonic or other "cold call" marketing of services at residences and provider sites; (ii) mailing directly; (iii) paying "finders' fees;" (iv) offering financial incentives, rewards, gifts or special opportunities to eligible individuals or family/caregivers as inducements to use the providers' services; (v) continuous, periodic marketing activities to the same prospective individual or family/caregiver for example, monthly, quarterly, or annual giveaways as inducements to use the providers' services; or (vi) engaging in marketing activities that offer potential customers rebates or discounts in conjunction with the use of the providers' services or other benefits as a means of influencing the individual's or family/caregiver's use of the providers' services.

"DMAS" means the Department of Medical Assistance Services.

"DSS" means the Department of Social Services.

"Enrollee" means a Medicaid-eligible individual meeting PACE enrollment criteria and receiving services from a PACE plan.

"Full disclosure" means fully informing all PACE enrollees at the time of enrollment that, pursuant to § 32.1-330.3 of the Code of Virginia, PACE plan enrollment can only be guaranteed for a 30-day period.

"Imminent risk of nursing facility placement" means that an individual will require nursing facility care within 30 days if a community-based alternative care program, such as a PACE plan, is not available.

"Long-term services and supports (LTSS) screening" or "screening" means the face to face process to (i) evaluate the functional, medical or nursing, and social support needs and at-risk status of individuals referred for certain long-term services requiring nursing facility level of care eligibility; (ii) assist individuals in determining what specific services the individual needs; (iii) evaluate whether a service or a combination of existing community services are available to meet the individual's needs; and (iv) provide a list to individuals of appropriate providers for Medicaid-funded nursing facility, PACE plan services, or the Commonwealth Coordinated Care Plus waiver for those individuals who meet nursing facility level of care.

"Long-term services and supports (LTSS) screening team" means the hospital screening team, community-based team (CBT), nursing facility team, or DMAS designee contracted to perform screenings pursuant to § 32.1-330 of the Code of Virginia.

"PACE" means a Program of All-Inclusive Care for the Elderly. PACE services are designed to enhance the quality of life and autonomy for frail, older adults; maximize dignity of, and respect for, older adults; enable frail, older adults to live in the community as long as medically and socially feasible; and preserve and support the older adult's family unit.

"PACE plan" means a comprehensive acute and long-term care prepaid health plan, pursuant to § 32.1-330.3 of the Code of Virginia and as defined in 42 CFR 460.6, operating on a capitated payment basis through which the PACE provider assumes full financial risk. PACE plans operate under both Medicare and Medicaid capitation.

"PACE plan contract" means a contract, pursuant to § 32.1-330.3 of the Code of Virginia, under which an entity assumes full financial risk for operation of a comprehensive acute and long-term care prepaid health plan with capitated payments for services provided to Medicaid enrollees being made by DMAS. The parties to a PACE plan contract are the entities operating the PACE plan, DMAS and CMS.

"PACE plan feasibility study" means a study performed by a research entity approved by DMAS to determine a potential PACE plan provider's ability and resources, or lack thereof, to effectively operate a PACE plan. All study costs are the responsibility of the potential PACE provider.

"PACE protocol" means the protocol for the Program of All-Inclusive Care for the Elderly, as published by On Lok, Inc., as of April 14, 1995, or any successor protocol that may be agreed upon by the federal Secretary of Health and Human Services and On Lok, Inc.

"PACE provider" means the entity contracting with the Department of Medical Assistance Services to operate a PACE plan.

"PACE site" means the location, which includes a primary care center, where the PACE provider both operates the PACE plan's adult day health care center and coordinates the provision of core PACE services, including the provision of primary care.

"Plan of care" means the written plan developed by the provider related solely to the specific services required by the individual to ensure optimal health and safety while receiving services from the provider.

"Primary care provider" or "PCP" means the individual responsible for the coordination of medical care provided to an enrollee under a PACE plan.

"Provider" means the individual or other entity registered, licensed, or certified, as appropriate, and enrolled by DMAS to render services to Medicaid recipients eligible for services.

"State Plan for Medical Assistance" or "the Plan" means the Commonwealth's legal document approved by CMS identifying the covered groups, covered services and their limitations, and provider reimbursement methodologies as provided for under Title XIX of the Social Security Act.

"Virginia Uniform Assessment Instrument" or "UAI" means the standardized, multidimensional assessment instrument that is completed by the LTSS screening team that assesses an individual's physical health, mental health, and psycho/social and functional abilities to determine if the individual meets the nursing facility level of care.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 8, eff. February 5, 2009; amended, Virginia Register Volume 37, Issue 23, eff. August 4, 2021.

12VAC30-50-335 General PACE plan requirements

A. DMAS, the state agency responsible for administering Virginia's Medicaid program, shall only enter into PACE plan contracts with approved PACE plan providers. The PACE provider must have an agreement with CMS and DMAS for the operation of a PACE program. The agreement must include:

1. Designation of the program's service area;

2. The program's commitment to meet all applicable federal, state, and local requirements;

3. The effective date and term of the agreement;

4. The description of the organizational structure;

5. Participant bill of rights;

6. Description of grievance and appeals processes;

7. Policies on eligibility, enrollment, and disenrollment;

8. Description of services available;

9. Description of the organization's quality improvement program;

10. A statement of levels of performance required on standard quality measures;

11. CMS and DMAS data requirements;

12. The Medicaid capitation rate or Medicaid payment rate methodology and the methodology used to calculate the Medicare capitation rate;

13. Procedures for program termination; and

14. A statement to hold harmless CMS, the state, and PACE participants if the PACE organization does not pay for services performed by the provider in accordance with the contract.

B. A PACE plan feasibility study shall be performed before DMAS enters into any PACE plan contract. DMAS shall contract only with those entities it determines to have the ability and resources to effectively operate a PACE plan. A feasibility plan shall only be submitted in response to a Request for Applications published by DMAS.

C. PACE plans shall offer a voluntary comprehensive alternative to enrollees who would otherwise be placed in a nursing facility. PACE plan services shall be comprehensive and offered as an alternative to nursing facility admission.

D. All Medicaid-enrolled PACE participants shall continue to meet the nonfinancial and financial Medicaid eligibility criteria established by federal law and this chapter. This requirement shall not apply to Medicare only or private pay PACE participants.

E. Each PACE provider shall operate a PACE site that is in continuous compliance with all state licensure requirements for that site.

F. Each PACE provider shall ensure that services are provided by health care providers and institutions that are in continuous compliance with state licensure and certification requirements.

G. Each PACE plan shall meet the requirements of §§ 32.1-330.2 and 32.1-330.3 of the Code of Virginia and 42 CFR Part 460.

H. All PACE providers must meet the general requirements and conditions for participation pursuant to the required contracts by DMAS and CMS. All providers must sign the appropriate participation agreement. All providers must adhere to the conditions of participation outlined in the participation agreement and application to provide PACE services, DMAS regulations, policies and procedures, and CMS requirements pursuant to 42 CFR Part 460.

I. Requests for participation as a PACE provider will be screened by DMAS to determine whether the provider applicant meets these basic requirements for participation and demonstrates the abilities to perform, at a minimum, the following activities:

1. Immediately notify DMAS, in writing, of any change in the information that the provider previously submitted to DMAS.

2. Assure freedom of choice to individuals in seeking services from any institution, pharmacy, practitioner, or other provider qualified to perform the services required and participating in the Medicaid Program at the time the services are performed.

3. Assure the individual's freedom to refuse medical care, treatment, and services.

4. Accept referrals for services only when qualified staff is available to initiate and perform such services on an ongoing basis.

5. Provide services and supplies to individuals in full compliance with Title VI of the Civil Rights Act of 1964, as amended (42 USC § 2000 et seq.), which prohibits discrimination on the grounds of race, color, religion, sexual orientation, or national origin; the Virginians with Disabilities Act (§ 51.5-1 et seq. of the Code of Virginia); § 504 of the Rehabilitation Act of 1973, as amended (29 USC § 794), which prohibits discrimination on the basis of a disability; and the Americans with Disabilities Act of 1990, as amended (42 USC § 12101 et seq.), which provides comprehensive civil rights protections to individuals with disabilities in the areas of employment, public accommodations, state and local government services, and telecommunications.

6. Provide services and supplies to individuals of the same quality and in the same mode of delivery as is provided to the general public.

7. Use only DMAS-designated forms for service documentation. The provider must not alter the DMAS forms in any manner unless approval from DMAS is obtained prior to using the altered forms.

8. Not perform any type of direct marketing activities to Medicaid individuals.

9. Maintain and retain business and professional records sufficient to document fully and accurately the nature, scope, and details of the services provided.

a. In general, such records shall be retained for at least 10 years from the last date of services or as provided by applicable federal and state laws, whichever period is longer. However, if an audit is initiated within the required retention period, the records shall be retained until the audit is completed and every exception resolved. Records of minors shall be kept for at least six years after such minor has reached the age of 18 years. However, records for Medicare Part D shall be maintained for 10 years in accordance with 42 CFR 423.505(d).

b. Policies regarding retention of records shall apply even if the provider discontinues operation. DMAS shall be notified in writing of the storage location and procedures for obtaining records for review. The location, agent, or trustee shall be within the Commonwealth.

10. Furnish information on request and in the form requested to DMAS, the Attorney General of Virginia or his authorized representatives, federal personnel, and the state Medicaid Fraud Control Unit. The Commonwealth's right of access to provider agencies and records shall survive any termination of the provider agreement.

11. Disclose, as requested by DMAS, all financial, beneficial, ownership, equity, surety, or other interests in any and all firms, corporations, partnerships, associations, business enterprises, joint ventures, agencies, institutions, or other legal entities providing any form of health care services to individuals of Medicaid.

12. Pursuant to 42 CFR 431.300 et seq., 12VAC30-20-90, and any other applicable federal or state law, all providers shall hold confidential and use for authorized DMAS purposes only all medical assistance information regarding individuals served. A provider shall disclose information in the provider's possession only when the information is used in conjunction with a claim for health benefits, or the data are necessary for the functioning of DMAS in conjunction with the cited laws.

13. CMS and DMAS shall be notified in writing of any change in the organizational structure of a PACE provider organization at least 14 calendar days before the change takes effect. When planning a change of ownership, CMS and DMAS shall be notified in writing at least 60 calendar days before the anticipated effective date of the change.

14. In addition to compliance with the general conditions and requirements, all providers enrolled by DMAS shall adhere to the conditions of participation outlined in their individual provider participation agreements and in the applicable DMAS provider manual. DMAS shall conduct ongoing monitoring of compliance with provider participation standards and DMAS policies. A provider's noncompliance with DMAS policies and procedures may result in a retraction of Medicaid payment or termination of the provider agreement, or both.

15. Minimum qualifications of staff.

a. All employees must have a satisfactory work record as evidenced by references from prior job experience, including no evidence of abuse, neglect, or exploitation of vulnerable adults and children. Prior to the beginning of employment, a criminal record check shall be conducted for the provider and each employee and made available for review by DMAS staff. Providers are responsible for complying with the Code of Virginia and state regulations regarding criminal record checks and barrier crimes as they pertain to the licensure and program requirements of their employees' particular practice areas.

b. Staff must meet any certifications, licensure, registration, etc., as required by applicable federal and state law. Staff qualifications must be documented and maintained for review by DMAS or its authorized contractors.

16. At the time of their admission to services, all providers participating in the Medicare and Medicaid programs must provide adult individuals with written information regarding each individual's right to make medical care decisions, including the right to accept or refuse medical treatment and the right to formulate advance directives.

J. Provider's conviction of a felony. The Medicaid provider agreement shall terminate upon conviction of the provider of a felony pursuant to § 32.1-325 of the Code of Virginia. A provider convicted of a felony in Virginia or in any other of the 50 states, the District of Columbia, or the U.S. territories must, within 30 days, notify the Virginia Medicaid Program of this conviction and relinquish the provider agreement. In addition, termination of a provider participation agreement will occur as may be required for federal financial participation.

K. Ongoing quality management review. DMAS shall be responsible for assuring continued adherence to provider participation standards. DMAS shall conduct ongoing monitoring of compliance with provider participation standards and DMAS policies and periodically recertify each provider for participation agreement renewal with DMAS to provide PACE services.

L. Reporting suspected abuse or neglect. Pursuant to §§ 63.2-1508 through 63.2-1513 and 63.2-1606 of the Code of Virginia, if a participating provider entity suspects that a child or vulnerable adult is being abused, neglected, or exploited, the party having knowledge or suspicion of the abuse, neglect, or exploitation shall report this immediately to DSS and to DMAS. In addition, as mandated reporters for vulnerable adults, participating providers must inform their staff that they are mandated reporters and provide education regarding how to report suspected adult abuse, neglect, or exploitation pursuant to § 63.2-1606 F of the Code of Virginia.

M. Documentation requirements. The provider must maintain all records of each individual receiving services. All documentation in the individual's record must be completely signed and dated with name of the person providing the service, title, and complete date with month, day, and year. This documentation shall contain, up to and including the last date of service, all of the following:

1. The Virginia Uniform Assessment Instrument (UAI) and all required forms in the LTSS screening packet pursuant to 12VAC30-60-306, all other assessments and reassessments, plans of care, supporting documentation, and documentation of any inpatient hospital admissions;

2. All correspondence and related communication with the individual and, as appropriate, consultants, providers, DMAS, DSS, or other related parties; and

3. Documentation of the date services were rendered and the amount and type of services rendered.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 8, eff. February 5, 2009; amended, Virginia Register Volume 32, Issue 24, eff. August 24, 2016; Volume 36, Issue 26, eff. September 16, 2020; Volume 37, Issue 23, eff. August 4, 2021.

12VAC30-50-340 Criteria for PACE enrollment

A. Eligibility shall be determined in the manner provided for in the State Plan and these regulations. To the extent these regulations differ from other provisions of the State Plan for purposes of PACE eligibility and enrollment, these regulations shall control.

B. Individuals meeting the following nonfinancial criteria shall be eligible to enroll in PACE plans approved by DMAS:

1. Individuals who are age 55 or older;

2. Individuals who require nursing facility level of care and are at imminent risk of nursing facility placement as determined by a LTSS screening team through a long-term services and supports screening performed using the UAI and all required forms in the LTSS screening packet pursuant to 12VAC30-60-306;

3. Individuals for whom PACE plan services are medically appropriate and necessary because without the services the individual is at imminent risk of nursing facility placement;

4. Individuals who reside in a PACE plan catchment area;

5. Individuals who meet other criteria specified in a PACE plan contract;

6. Individuals who participate in the Medicaid or Medicare programs as specified in § 32.1-330.3 E of the Code of Virginia; and

7. Individuals who voluntarily enroll in a PACE plan and agree to the terms and conditions of enrollment.

C. To the extent permitted by federal law and regulation, individuals meeting the following financial criteria shall be eligible to enroll in PACE plans approved by DMAS:

1. Individuals whose income is determined by DMAS under the provision of the State Plan to be equal to or less than 300% of the current Supplemental Security Income payment standard for one person; and

2. Individuals whose resources are determined by DMAS under the provisions of the State Plan to be equal to or less than the current resource allowance established in the State Plan.

D. For purposes of a financial eligibility determination, applicants shall be considered as if they are institutionalized for the purpose of applying institutional deeming rules.

E. DMAS shall not pay for services provided to an applicant by a PACE contractor if such services are provided prior to the PACE plan authorization date set by the LTSS screening team.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 8, eff. February 5, 2009; amended, Virginia Register Volume 37, Issue 23, eff. August 4, 2021.

12VAC30-50-345 PACE enrollee rights

A. PACE providers shall ensure that enrollees are fully informed of their rights and responsibilities in accordance with all state and federal requirements. These rights and responsibilities shall include:

1. The right to be fully informed at the time of enrollment that PACE plan enrollment can only be guaranteed for a 30-day period pursuant to § 32.1-330.3 F of the Code of Virginia;

2. The right to receive PACE plan services directly from the provider or under arrangements made by the provider; and

3. The right to be fully informed in writing of any action to be taken affecting the receipt of PACE plan services.

B. PACE providers shall notify enrollees of the full scope of services available under a PACE plan, as described in 42 CFR 460.92. The services shall include:

1. Medical services, including the services of a PCP and other specialists;

2. Transportation services;

3. Outpatient rehabilitation services, including physical, occupational, and speech therapy services;

4. Hospital (acute care) services;

5. Nursing facility (long-term care) services;

6. Prescription drugs;

7. Home health services;

8. Laboratory services;

9. Radiology services;

10. Ambulatory surgery services;

11. Respite care services;

12. Personal care services;

13. Dental services;

14. Adult day health care services, to include social work services;

15. Interdisciplinary case management services;

16. Outpatient mental health and intellectual disability services;

17. Outpatient psychological services;

18. Prosthetics; and

19. Durable medical equipment and other medical supplies.

C. Services available under a PACE plan shall not include any of the following:

1. Any service not authorized by the interdisciplinary team unless such service is an emergency service (i.e., a service provided in the event of a situation of a serious or urgent nature that endangers the health, safety, or welfare of an individual and demands immediate action);

2. In an inpatient facility, private room and private duty nursing services unless medically necessary, and nonmedical items for personal convenience such as telephones charges and radio or television rental, unless specifically authorized by the interdisciplinary team as part of the participant's plan of care;

3. Cosmetic surgery except as described in agency guidance documents;

4. Any experimental medical, surgical, or other health procedure; and

5. Any other service excluded under 42 CFR 460.96.

D. PACE providers shall ensure that PACE plan services are at least as accessible to enrollees as they are to other Medicaid-eligible individuals residing in the applicable catchment area.

E. PACE providers shall provide enrollees with access to services authorized by the interdisciplinary team 24 hours per day every day of the year.

F. PACE providers shall provide enrollees with all information necessary to facilitate easy access to services.

G. PACE providers shall provide enrollees with identification documents approved by DMAS. PACE plan identification documents shall give notice to others of enrollees' coverage under PACE plans.

H. PACE providers shall clearly and fully inform each enrollee of that enrollee's right to disenroll at any time and have such disenrollment be effective the first day of the month following the date the PACE organization receives the enrollee's notice of voluntary disenrollment.

I. PACE providers shall make available to enrollees a mechanism whereby disputes relating to enrollment and services can be considered. This mechanism shall be one that is approved by DMAS.

J. PACE providers shall fully inform enrollees of the individual provider's policies regarding accessing care generally and, in particular, accessing urgent or emergency care both within and without the catchment area.

K. PACE providers shall maintain the confidentiality of enrollees and the services provided to them.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 8, eff. February 5, 2009; amended, Virginia Register Volume 36, Issue 26, eff. September 16, 2020.

12VAC30-50-350 PACE enrollee responsibilities

A. Enrollees shall access services through an assigned PCP. Enrollees shall be given the opportunity to choose a PCP affiliated with the applicable PACE provider. In the event an enrollee fails to choose a PCP, one shall be assigned by the provider.

B. Enrollees shall be responsible for copayments, if any.

C. Enrollees shall raise complaints relating to PACE plan coverage and services directly with the PACE provider. The provider shall have a DMAS-approved enrollee complaint process in place at all times.

D. Enrollees shall raise complaints pertaining to Medicaid eligibility and PACE plan eligibility directly to DMAS. These complaints shall be considered under DMAS' Client Appeals regulations (12VAC30-110).

E. The PACE provider shall have a grievance process in place including procedures for filing an enrollee's grievance, documenting the grievance, responding to and resolving the grievance in a timely manner, and maintaining confidentiality of the agreement pursuant to 42 CFR 460.120.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 8, eff. February 5, 2009.

12VAC30-50-355 PACE plan contract requirements and standards

A. Pursuant to 42 CFR Part 460 and § 32.1-330.3 of the Code of Virginia, DMAS shall establish contract requirements and standards for PACE providers.

B. At the point of PACE plan contract agreement, DMAS shall modify 12VAC30-50-320 accordingly and submit it to CMS.

C. Any expansion of PACE programs shall be on a schedule and within an area determined solely at the discretion of DMAS through a Request for Applications (RFA) process. No organization shall begin any new PACE program without going through the RFA process as required by DMAS.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 8, eff. February 5, 2009.

12VAC30-50-360 PACE sanctions

A. DMAS shall apply sanctions to providers for violations of PACE contract provisions or federal or state law and regulation.

B. Permissible state sanctions shall include, but need not be limited to, the following:

1. A written warning to the provider;

2. Withholding all or part of the PACE provider's capitation payments, or retracting all or part of any reimbursement previously paid;

3. Suspension of new enrollment in the PACE plan;

4. Restriction of current enrollment in the PACE plan; and

5. Contract termination.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 8, eff. February 5, 2009.

Part IV Case Management Services

12VAC30-50-410 Case management services for high risk pregnant women and children

A. Target Group: To reimburse case management services for high-risk Medicaid eligible pregnant women and children up to age 2.

B. Services will be provided to the entire state.

C. Comparability of Services: Services are not comparable in amount, duration, and scope. Authority of section 1915(g)(1) of the Act is invoked to provide services without regard to the requirements of section 1902(a)(10)(B) of the Act.

D. Definition of Services: The case management services will provide maternal and child health coordination to minimize fragmentation of care, reduce barriers, and link clients with appropriate services to ensure comprehensive, continuous health care. The Maternity Care Coordinator will provide:

1. Assessment-Determining clients' service needs, which include psychosocial, nutrition, medical, and educational factors.

2. Service Planning-Developing an individualized description of what services and resources are needed to meet the service needs of the client and help access those resources.

3. Coordination & Referral-Assisting the client in arranging for appropriate services and ensuring continuity of care.

4. Follow-up & Monitoring-Assessing ongoing progress and ensuring services are delivered.

5. Education & Counseling-Guiding the client and developing a supportive relationship that promotes the service plan.

E. Qualifications of Providers: Any duly enrolled provider which the Department determines is qualified who has signed an agreement with Department of Medical Assistance Services to deliver Maternity Care Coordination services. Qualified service providers will provide case management regardless of their capacity to provide any other services under the Plan. A Maternity Care Coordinator is the Registered Nurse or Social Worker employed by a qualified service provider who provides care coordination services to eligible clients. The RN must be licensed in Virginia and should have a minimum of one year of experience in community health nursing and experience in working with pregnant women. The Social Worker (MSW, BSW) must have a minimum of one year of experience in health and human services, and have experience in working with pregnant women and their families. The Maternity Care Coordinator assists clients in accessing the health care and social service system in order that outcomes which contribute to physical and emotional health and wellness can be obtained.

F. The State assures that the provision of case management services will not restrict an individual's free choice of providers in violation of § 1902(a)(23) of the Act.

1. Eligible recipients will have free choice of the providers of case management services.

2. Eligible recipients will have free choice of the providers of other medical care under the plan.

G. Payment for case management services under the plan does not duplicate payments made to public agencies or private entities under other program authorities for this same purpose.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-03-3.1102 § 1, eff. May 1, 1994.

12VAC30-50-415 Case management for individuals receiving early intervention (Part C) services

A. Target group for early intervention case management. Medicaid eligible children from birth up to three years of age who have (i) a 25% developmental delay in one or more areas of development, (ii) atypical development, or (iii) a diagnosed physical or mental condition that has a high probability of resulting in a developmental delay who participate in the early intervention services system described in Chapter 53 (§ 2.2-5300 et seq.) of Title 2.2 of the Code of Virginia are the target group.

B. Services are provided throughout the Commonwealth.

C. Services are not comparable in amount, duration, and scope. The authority of § 1915(g)(1) of the Social Security Act (the Act) is invoked to provide services without regard to the requirements of § 1902(a)(10)(B) of the Act.

D. Definition of services. Early intervention case management services are services furnished to assist individuals eligible under the State Plan who reside in a community setting in gaining access to medical, social, educational, and other services. Early intervention case management includes the following assistance:

1. Comprehensive assessment and at least annual reassessment of individual needs to determine the need for any medical, educational, social, or other services, including EPSDT services.

2. Development and at least annual revision of an individualized family service plan (IFSP) as defined in coverage of early intervention services under Part C of Individuals with Disabilities Education Act (IDEA) (12VAC30-50-131) based on the information collected through the assessment. A face-to-face contact with the child's family is required for the initial development and revision of the IFSP. The case manager shall be responsible for determining if the family's particular situation warrants additional face-to-face visits.

3. Referral and related activities to help the eligible individual obtain needed services, including activities that help link the individual with medical, social, and educational providers or other programs and services that are capable of providing needed services to address identified needs and achieve goals specified in the IFSP.

4. Monitoring and follow-up activities, including activities and contacts that are necessary to ensure that the IFSP is effectively implemented and adequately addresses the needs of the eligible individual. At a minimum one telephone, email, or face-to-face contact shall be made with the child's family every three calendar months, or attempts of such contacts. This contact or attempted contact shall be documented. The case manager shall be responsible for determining if the family's particular situation warrants additional family contacts.

5. Early intervention case management includes contacts with family members, service providers, and other noneligible individuals and entities who have direct knowledge of the eligible individual's needs and care.

E. Qualifications of providers. Individual providers of early intervention case management must be certified as early intervention case managers by the Department of Behavioral Health and Developmental Services.

F. Freedom of choice. The Commonwealth assures that the provision of case management services will not restrict an eligible individual's freedom of choice of providers.

1. Eligible recipients shall have free choice of the providers of early intervention case management services within the specified geographic area identified in this plan.

2. Eligible recipients shall have free choice of the providers of other medical care under the plan.

3. Providers of early intervention case management shall be limited to entities designated by the local lead agencies under contract with the Department of Behavioral Health and Developmental Services pursuant to § 2.2-5304.1 of the Code of Virginia.

G. Access to services. The Commonwealth assures the following:

1. Case management services shall be provided in a manner consistent with the best interest of recipients and shall not be used to restrict an individual's access to other Medicaid services.

2. Individuals shall not be compelled to receive case management services. The receipt of other Medicaid services shall not be a condition for the receipt of case management services, and the receipt of case management services shall not be a condition for receipt of other Medicaid services.

3. Providers of case management services do not exercise DMAS authority to authorize or deny the provision of other Medicaid services.

H. Payment for early intervention case management services shall not duplicate payments made to public agencies or private entities under other program authorities for this same purpose.

I. Case records. Case management services shall be documented and maintained in individual case records in accordance with 42 CFR 441.18(a)(7). Case records shall include:

1. The name of the individual;

2. The dates of the case management services;

3. The name of the provider agency and the person providing the case management services;

4. The nature, content, and units of the case management services received and whether the goals specified in the care plan have been achieved;

5. Whether the individual has declined services in the care plan;

6. The need for, and occurrences of, coordination with other case managers;

7. A timeline for obtaining needed services; and

8. A timeline for reevaluation of the plan.

J. Limitations.

1. Early intervention case management shall not include the following:

a. Activities not consistent with the definition of case management services in 42 CFR 440.169.

b. The direct delivery of an underlying medical, educational, social, or other service to which an eligible individual has been referred.

c. Activities integral to the administration of foster care programs.

d. Activities for which third parties are liable to pay, except for case management that is included in an IFSP consistent with § 1903(c) of the Social Security Act.

2. Providers shall not be reimbursed for case management services provided for these groups when these children also fall within the target group for early intervention case management as set out in this subdivision:

a. Seriously mentally ill adults and emotionally disturbed children (12VAC30-50-420);

b. Youth at risk of serious emotional disturbance (12VAC30-50-430);

c. Individuals with intellectual disability (12VAC30-50-440); or

d. Individuals with intellectual disability and related conditions who are participants in the home and community-based care waivers for persons with intellectual disability and related conditions (12VAC30-50-450).

3. Case management shall be reimbursed only when all of the following conditions are met:

a. A least one documented case management service is furnished during the month; and

b. The provider is certified by the Department of Behavioral Health and Developmental Services and enrolled with DMAS as an early intervention case management provider.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 31, Issue 9, eff. February 13, 2015.

12VAC30-50-420 Case management services for seriously mentally ill adults and emotionally disturbed children

A. Target group for case management services for seriously mentally ill adults and emotionally disturbed children. The Medicaid-eligible individual shall meet the definition for "serious mental illness" pursuant to 42 CFR 483.102(b)(1) or "serious emotional disturbance in children and adolescents" pursuant to Appendix A of the Department of Behavioral Health and Developmental Services (DBHDS) Core Services Taxonomy 7.3.

1. An active client for case management shall mean an individual for whom there is a plan of care in effect that requires regular direct or client-related contacts or communication or activity with the client, family, service providers, significant others, and others, including at least one face-to-face contact every 90 days. Billing can be submitted for an active client only for months in which direct or client-related contacts, activity, or communications occur. Authorization is required for Medicaid reimbursement.

2. There shall be no maximum service limits for case management services. In accordance with 42 CFR 441.18(a)(8)(vii), reimbursement is allowed for case management services for Medicaid-eligible individuals who are in institutions, with the exception of individuals who are 22 years of age to 64 years of age and are served in institutions of mental diseases (IMDs) and individuals of any age who are inmates of public institutions. An IMD is a facility that is primarily engaged in the treatment of mental illness and has more than 16 beds in accordance with § 1905(i) of the Social Security Act.

3. For individuals who are 22 years of age to 64 years of age, services rendered during the same month as the admission to the IMD are reimbursable as long as the service was rendered prior to the date of the admission.

4. Case management services for individuals who are younger than 22 years of age or older than 64 years of age in an IMD may be billed 30 calendar days prior to discharge as long as the case management services do not duplicate other services provided by the institution.

B. Services for seriously mentally ill adults and emotionally disturbed children will be provided to the entire state.

C. Comparability of case management services for seriously mentally ill adults and emotionally disturbed children. Services are not comparable in amount, duration, or scope. Authority of § 1915(g)(1) of the Social Security Act is invoked to provide services without regard to the requirements of § 1902(a)(10)(B) of the Social Security Act.

D. Definition of case management services for seriously mentally ill adults and emotionally disturbed children. Case management services assist individual children and adults in accessing needed medical, psychiatric, social, educational, vocational, and other supports essential to meeting basic needs. Services to be provided include:

1. Assessment and planning services, to include developing an individual service plan (ISP) (does not include performing medical and psychiatric assessment but does include referral for such assessment);

2. Linking the individual to services and supports specified in the ISP;

3. Assisting the individual directly for the purpose of locating, developing, or obtaining needed services and resources;

4. Coordinating services and service planning with other agencies and providers involved with the individual;

5. Enhancing community integration by contacting other entities to arrange community access and involvement, including opportunities to learn community living skills and use vocational, civic, and recreational services;

6. Making collateral contacts with the individual's significant others to promote implementation of the service plan and community adjustment;

7. Follow-up and monitoring to assess ongoing progress and to ensure services are delivered; and

8. Education and counseling that guides the client and develops a supportive relationship that promotes the service plan.

E. Qualifications of providers of case management services for seriously mentally ill adults and emotionally disturbed children.

1. Services are not comparable in amount, duration, or scope. Authority of § 1915(g)(1) of the Social Security Act is invoked to limit case management providers for individuals with a developmental disability and individuals with serious or chronic mental illness to the Community Services Boards only to enable them to provide services to individuals with a developmental disability or serious or chronic mental illness without regard to the requirements of § 1902(a)(10)(B) of the Social Security Act.

2. To qualify as a provider of services through DMAS for rehabilitative mental health case management, the provider of the services must meet the following criteria:

a. The provider must have the administrative and financial management capacity to meet state and federal requirements;

b. The provider must have the ability to document and maintain individual case records in accordance with state and federal requirements;

c. The services shall be in accordance with the Virginia Comprehensive State Plan;

d. The provider must be licensed as a provider of case management services by DBHDS;

e. Persons providing case management services must have knowledge of:

(1) Services, systems, and programs available in the community, including primary health care, support services, eligibility criteria and intake processes, generic community resources, and mental health, developmental disability, and substance abuse treatment programs;

(2) The nature of serious mental illness, developmental disability, and substance abuse depending on the population served, including clinical and developmental issues;

(3) Different types of assessments, including functional assessments, and their uses in service planning;

(4) Treatment modalities and intervention techniques, such as behavior management, independent living skills training, supportive counseling, family education, crisis intervention, discharge planning, and service coordination;

(5) The service planning process and major components of a service plan;

(6) The use of medications in the care or treatment of the population served; and

(7) All applicable federal and state laws, state regulations, and local ordinances;

f. Persons providing case management services must have skills in:

(1) Identifying and documenting an individual's needs for resources, services, and other supports;

(2) Using information from assessments, evaluations, observation, and interviews to develop ISPs;

(3) Identifying services and resources within the community and established service system to meet the individual's needs and documenting how resources, services, and natural supports, such as family, can be utilized to achieve an individual's personal habilitative or rehabilitative and life goals; and

(4) Coordinating the provision of services by public and private providers; and

g. Persons providing case management services must have abilities to:

(1) Work as team members, maintaining effective inter-agency and intra-agency working relationships;

(2) Work independently, performing position duties under general supervision; and

(3) Engage in and sustain ongoing relationships with individuals receiving services.

3. Providers may bill Medicaid for mental health case management only when the services are provided by qualified mental health case managers.

F. The state ensures that the provision of case management services will not restrict an individual's free choice of providers in violation of § 1902(a)(23) of the Social Security Act.

1. Eligible recipients will have free choice of the providers of case management services.

2. Eligible recipients will have free choice of the providers of other medical care under the plan.

G. Payment for case management services under the plan shall not duplicate payments made to public agencies or private entities under other program authorities for this same purpose.

H. Case management services may not be billed concurrently with intensive community treatment services, treatment foster care case management services, or intensive in-home services for children and adolescents.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-03-3.1102 § 2, eff. May 1, 1994; amended, Virginia Register Volume 20, Issue 7, eff. February 1, 2004; Volume 27, Issue 10, eff. February 16, 2011; Volume 41, Issue 7, eff. January 2, 2025.

12VAC30-50-430 Case management services for youth at risk of serious emotional disturbance

A. Target group for case management services for youth at risk of serious emotional disturbance. Medicaid-eligible individuals who meet the definition of youth at risk of serious emotional disturbance pursuant to Appendix A of the Department of Behavioral Health and Developmental Services (DBHDS) Core Services Taxonomy 7.3.

1. An active client shall mean an individual for whom there is a plan of care in effect that requires regular direct or client-related contacts or communication or activity with the client, family, service providers, significant others, and others, including at least one face-to-face contact every 90 days. Billing can be submitted for an active client only for months in which direct or client-related contacts, activity, or communications occur. Authorization is required for Medicaid reimbursement.

2. There shall be no maximum service limits for case management services. Case management services must not be billed for individuals who are in institutions for mental diseases, except for the 30 calendar days prior to discharge as long as the case management services do not duplicate other services provided by the institution. Case management services must not be billed for individuals who are inmates of public institutions.

B. Services for youth at risk of serious emotional disturbance will be provided in the entire state.

C. Comparability of case management services for youth at risk of serious emotional disturbance. Services are not comparable in amount, duration, or scope. Authority of § 1915(g)(1) of the Social Security Act is invoked to provide services without regard to the requirements of § 1902(a)(10)(B) of the Social Security Act.

D. Definition of case management services for youth at risk of serious emotional disturbance. Case management services assist youth at risk of serious emotional disturbance in accessing needed medical, psychiatric, social, educational, vocational, and other supports essential to meeting basic needs. Services to be provided include:

1. Assessment and planning services, to include developing an individual service plan (ISP);

2. Linking the individual directly to services and supports specified in the treatment or services plan;

3. Assisting the individual directly for the purpose of locating, developing, or obtaining needed service and resources;

4. Coordinating services and service planning with other agencies and providers involved with the individual;

5. Enhancing community integration by contacting other entities to arrange community access and involvement, including opportunities to learn community living skills and use vocational, civic, and recreational services;

6. Making collateral contacts, which are nontherapy contacts, with an individual's significant others to promote treatment or community adjustment;

7. Following up and monitoring to assess ongoing progress and ensuring services are delivered; and

8. Providing education and counseling that guides the client and develops a supportive relationship that promotes the service plan.

E. Qualifications of providers of case management services for youth at risk of serious emotional disturbance.

1. Services are not comparable in amount, duration, or scope. Authority of § 1915(g)(1) of the Social Security Act is invoked to limit case management providers to the community services boards only to enable them to provide services to individuals with a developmental disability or serious or chronic mental illness without regard to the requirements of § 1902(a)(10)(B) of the Social Security Act. To qualify as a provider of case management services to youth at risk of serious emotional disturbance, the provider of the services must meet the following criteria:

a. The provider must meet state and federal requirements regarding capacity for administrative and financial management;

b. The provider must document and maintain individual case records in accordance with state and federal requirements;

c. The provider must provide services in accordance with the Virginia Comprehensive State Plan;

d. The provider must be licensed as a provider of case management services by DBHDS;

e. Persons providing case management services must have knowledge of:

(1) Services, systems, and programs available in the community, including primary health care, support services, eligibility criteria, and intake processes, generic community resources, and mental health, developmental disability, and substance abuse treatment programs;

(2) The nature of serious mental illness, developmental disability, or substance abuse depending on the population served, including clinical and developmental issues;

(3) Different types of assessments, including functional assessments, and their uses in service planning;

(4) Treatment modalities and intervention techniques, such as behavior management, independent living skills training, supportive counseling, family education, crisis intervention, discharge planning, and service coordination;

(5) The service planning process and major components of a service plan;

(6) The use of medications in the care or treatment of the population served; and

(7) All applicable federal and state laws, state regulations, and local ordinances;

f. Persons providing case management services must have skills in:

(1) Identifying and documenting an individual's need for resources, services, and other supports;

(2) Using information from assessments, evaluations, observation, and interviews to develop ISPs;

(3) Identifying services and resources within the community and established service system to meet the individual's needs and documenting how resources, services, and natural supports, such as family, can be utilized to achieve an individual's personal habilitative or rehabilitative and life goals; and

(4) Coordinating the provision of services by diverse public and private providers; and

g. Persons providing case management services must have abilities to:

(1) Work as team members, maintaining effective inter-agency and intra-agency working relationships;

(2) Work independently performing position duties under general supervision; and

(3) Engage in and sustain ongoing relationships with individuals receiving services.

F. Providers may bill Medicaid for mental health case management to youth at risk of serious emotional disturbance only when the services are provided by qualified mental health case managers.

G. The state ensures that the provision of case management services will not restrict an individual's free choice of providers in violation of § 1902(a)(23) of the Social Security Act.

1. Eligible recipients will have free choice of the providers of case management services.

2. Eligible recipients will have free choice of the providers of other medical care under the plan.

H. Payment for case management services under the plan must not duplicate payments made to public agencies or private entities under other program authorities for this same purpose.

I. Case management may not be billed concurrently with intensive community treatment services, treatment foster care case management services, or intensive in-home services for children and adolescents.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-03-3.1102 § 3, eff. May 1, 1994; amended, Virginia Register Volume 20, Issue 7, eff. February 1, 2004; Volume 27, Issue 10, eff. February 16, 2011; Volume 41, Issue 7, eff. January 2, 2025.

12VAC30-50-440 Support coordination/case management services for individuals with intellectual disability

A. Target Group. Medicaid eligible individuals who have an intellectual disability as defined in § 37.2-100 of the Code of Virginia.

1. An active individual for intellectual disability support coordination/case management shall mean a person for whom there is an individual support plan (ISP) (as defined in 12VAC30-122-20) in effect that requires direct or -related individual-related contacts or communication or activity with the individual, the individual's family or caregiver, service providers, significant others, and others including at least one face-to-face contact with the individual every 90 days. Billing can be submitted for an active individual only for months in which direct or -related individual-related contacts, activity, or communications occur, consistent with the ISP.

2. The unit of service is one month. There shall be no maximum service limits for support coordination/case management services except services for as related to individuals residing in institutions or medical facilities. For these individuals, reimbursement for support coordination/case management shall be limited to 30 days immediately preceding discharge. Support coordination/case management for individuals who reside in an institution may be billed for no more than two predischarge periods within 12 months.

B. Services will be provided in the entire state.

C. Comparability of services: Services are not comparable in amount, duration, and scope. Authority of § 1915(g)(1) of the Social Security Act (the Act) is invoked to provide services without regard to the requirements of § 1902(a)(10)(B) of the Act.

D. Definition of services. Intellectual disability support coordination/case management services to be provided include:

1. Assessment and planning services, to include developing an individual support plan (ISP) as defined on 12VAC30-122-20 and in accordance with the requirements of the Final Rule found at 42 CFR 441.725, which does not include performing medical and psychiatric assessment but does include referral for assessment;

2. Linking the individual to services and supports specified in the ISP;

3. Assisting the individual directly for the purpose of locating, identifying, or obtaining needed services and resources;

4. Coordinating services and service planning with other agencies and providers involved with the individual;

5. Enhancing community integration by contacting other entities to arrange community access and involvement, including opportunities to learn community living skills and to use vocational, civic, and recreational services;

6. Making collateral contacts with the individual's significant others to promote implementation of the ISP and community integration;

7. Following up and monitoring to assess ongoing progress and ensuring services are delivered; and

8. Education and counseling that guides the individual and develops a supportive relationship that promotes the ISP.

E. Qualifications of providers:

1. are not comparable in amount, duration, and scope. Authority of § 1915(g)(1) of the Act is invoked to limit Support coordination/case management providers for individuals with intellectual disability shall be limited to the community services boardsally. References to providers in this section shall refer to enrolled community services boards.

2. To qualify as a provider of services enrolled with DMAS for intellectual disability support coordination/case management, the provider of the services shall meet certain criteria. These criteria shall be:

a. The provider shall guarantee that s individuals have access to emergency services on a 24-hour basis;

b. The provider shall demonstrate the ability to serve individuals in need of comprehensive services regardless of the individual's ability to pay or eligibility for Medicaid reimbursement;

c. The provider shall have the administrative and financial management capacity to meet state and federal requirements;

d. The provider have the ability to shall document and maintain individual case records in accordance with state and federal requirements;

e. The provider shall submit the individual support plan in an electronic format in the state DD home and community-based services (HCBS) waiver management system for service authorization and data management for individuals enrolled in any DD HCBS waiver. The provider shall submit evidence to Department of Medical Assistance Services (DMAS) or the Department of Behavioral Health and Developmental Services (DBHDS) in specified format of follow-up and monitoring to assess ongoing progress of the ISP, ensuring services are delivered and health and safety is maintained;

f. The provider shall participate in activities designed to safeguard participants' health and safety in accordance with approved DD HCBS waiver requirements or DBHDS licensing standards; and

g. The provider shall participate in activities designed to assure ongoing compliance by DD HCBS waiver participants' providers of service subject to the Final Rule Settings Requirements found at 42 CFR 441.301(4) and as described in the approved Statewide Transition Plan;

h. The services shall be in accordance with the Virginia State Plan for Medical Assistance; and

i. The provider must be licensed as a developmental disability support coordination/case management agency by the Department of Behavioral Health and Developmental Services.

3. Providers may bill for Medicaid intellectual disability support coordination/case management only when the services are provided by qualified managers support coordinators/case managers. The manager must support coordinator/case manager shall possess a combination of intellectual disability work experience and relevant education that indicates that the incumbent, at entry level, possesses the knowledge, skills, and abilities listed in this subdivision. These must be documented observable in the application form or supporting documentation or observable and documented during the interview (with appropriate supporting documentation).

a. Knowledge of:

(1) The definition and causes of intellectual disability and best practices in supporting individuals who have intellectual disability;

(2) Treatment modalities and intervention techniques, such as positive behavior supports, person-centered practices, independent living skills training, community inclusion/employment skills, supportive guidance, family education, crisis intervention, discharge planning, and support coordination;

(3) Different types of assessments and their uses in service planning;

(4) Individuals' civil and human rights;

(5) Local community resources and service delivery systems, including support services, eligibility criteria and intake process, termination criteria and procedures, and generic community resources;

(6) Types of intellectual disability programs and services;

(7) Effective oral, written, and interpersonal communication principles and techniques;

(8) General principles of documentation; and

(9) The service planning process and the major components of an ISP.

b. Skills in:

(1) Interviewing;

(2) Negotiating with individuals and service providers;

(3) Observing recording and reporting and documenting an individual's behaviors;

(4) Identifying and documenting an individual's needs for resources, services, and other assistance;

(5) Identifying services within the established service system to meet the individual's needs and preferences;

(6) Coordinating the provision of services for the individual by diverse public and private providers, generic and natural supports;

(7) Using information from assessments, evaluations, observations, and interviews to develop and revise as needed support plans;

(8) Formulating, writing, and implementing ized consumer individual support plans to promote goal attainment and community integration for individuals with intellectual disability;

(9) Using information from assessment tools, evaluations, observations, and interviews to develop and revise as needed individual support plans (for example to ensure the ISP is implemented appropriately, identify change in status or to determine risk of crisis/hospitalization); and

(10) Identifying community resources and organizations and coordinating resources and activities.

c. Abilities to:

(1) Demonstrate a positive regard for individuals and their families (e.g., treating people as individuals, allowing risk taking, avoiding stereotypes of people with intellectual disability, respecting individual and family privacy, and believing individuals can grow and contribute to their communities);

(2) Be persistent and remain objective;

(3) Work as team member, maintaining effective ter- interagency and intra-agency working relationships;

(4) Work independently, performing position duties under general supervision;

(5) Communicate effectively, verbally and in writing; and

(6) Establish and maintain ongoing supportive relationships.

F. The state assures that the provision of support coordination/case management services will not restrict an individual's free choice of providers in violation of § 1902(a)(23) of the Act and the Final Rule at 42 CFR 441.301(c)(1)(vi).

1. Enrolled individuals will have free choice of the available providers of support coordination/case management services.

2. Enrolled individuals will have free choice of the providers of other medical care under the State Plan for Medical Assistance.

G. Payments for support coordination/case management services under the does State Plan for Medical Assistance shall not duplicate payments made to public agencies or private entities under other program authorities for this same purpose.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-03-3.1102 § 4, eff. May 1, 1994; amended, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-50-450 (Repealed.)

History

• Historical Notes: Derived from VR460-03-3.1102 § 5, eff. May 1, 1994; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-50-460 (Repealed.)

Historical Notes

Derived from VR460-03-3.1102 § 6, eff. May 1, 1994; repealed, Virginia Register Volume 19, Issue 18, eff. July 1, 2003.

12VAC30-50-470 (Repealed.)

History

• Historical Notes: Derived from VR460-03-3.1102 § 7, eff. June 1, 1994; amended, Virginia Register Volume 12, Issue 12, eff. April 4, 1996; repealed, Virginia Register Volume 41, Issue 19, eff. June 19, 2025.

12VAC30-50-480 Case management for foster care children

A. Target group. Children or youth with behavioral disorders or emotional disturbances who are referred to treatment foster care by the Family Assessment and Planning Team of the Comprehensive Services Act for Youth and Families (CSA). "Child" or "youth" means any Medicaid eligible individual to 21 years of age who is otherwise eligible for CSA services. Family Assessment and Planning Teams (FAPT) are multidisciplinary teams of professionals established by each locality in accordance with §§ 2.1-753, 2.1-754, and 2.1-755 of the Code of Virginia to assess the needs of referred children. The FAPT shall develop individual services plans for youths and families who are reviewed by the team. The FAPT shall refer those children needing treatment foster care case management to a qualified participating case manager.

B. Services will be provided in the entire state.

C. Services are not comparable in amount, duration, and scope. Authority of § 1915(g)(1) of the Act is invoked to provide services without regard to the requirements of § 1902(a)(10)(B) of the Act.

D. Definition of services. Case management shall assist individuals eligible for Medicaid in gaining and coordinating access to necessary care and services appropriate to the needs of a child. Case management services will coordinate services to minimize fragmentation of care, reduce barriers, and link children with appropriate services to ensure comprehensive, continuous access to needed medical, social, educational, and other services appropriate to the needs of the child. The foster care case manager will provide:

1. Periodic assessments to determine clients' needs for psychosocial, nutritional, medical, and educational services.

2. Service planning by developing individualized treatment and service plans to describe what services and resources are needed to meet the service needs of the client and help access those resources. Such service planning shall not include performing medical and psychiatric assessment but shall include referrals for such assessments. The case manager shall collaborate closely with the FAPT and other involved parties in preparation of all case plans.

3. Coordination and referral by assisting the client in arranging for appropriate services and ensuring continuity of care for a child in treatment foster care. The case manager shall link the child to services and supports specified in the individualized treatment and service plan. The case manager shall directly assist the child to locate or obtain needed services and resources. The case manager shall coordinate services and service planning with other agencies and providers involved with the child by arranging, as needed, medical, remedial, and dental services.

4. Followup and monitoring by assessing ongoing progress in each case and ensuring services are delivered. The case manager shall continually evaluate and review each child's plan of care. The case manager shall collaborate with the FAPT and other involved parties on reviews and coordination of services to youth and families.

5. Education and counseling by guiding the client and developing a supportive relationship that promotes the service plan.

E. Provider participation. Any public or private child-placing agency licensed or certified by the Department of Social Services for treatment foster care may be a provider of treatment foster care case management.

Providers may bill Medicaid for case management for children in treatment foster care only when the services are provided by qualified treatment foster care case managers. The case manager must meet, at a minimum, the case worker qualifications found in the Minimum Standards for Licensed Child-Placing Agencies (22VAC40-130-10 et seq.).

F. Freedom of choice. Section 1915(g)(1) of the Act specifies that there shall be no restriction on free choice of qualified providers, in violation of § 1902(a)(23) of the Act. The state assures that there will be no restriction on a recipient's free choice of qualified providers of case management services. In addition, the state assures that case management services will not restrict an individual's free choice of providers of other Medicaid services.

1. Eligible recipients will have free choice of the providers of case management services.

2. Eligible recipients will have free choice of the providers of other medical care under the plan.

3. Eligible recipients will be free to refuse case management services.

G. Payment for case management services under the plan does not duplicate payments made to public agencies or private entities under other program authorities for this same purpose. The case management services will be funded from Medicaid service funds, not administrative. This case management service shall not be construed as case management under EPSDT.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 5, eff. January 1, 2001.

12VAC30-50-490 Support coordination/case management for individuals with developmental disabilities

A. Target group. Medicaid-eligible individuals with developmental disability (other than intellectual disability) or related conditions as defined in § 37.2-100 of the Code of Virginia who are on the waiting list or are receiving services under one of the Developmental Disabilities (DD) Waivers.

1. When an individual applies for the DD Waivers and is found to meet the criteria as defined in 12VAC30-122-50, but there is no available slot, the individual will be placed on a waitlist until a slot is available. Individuals on the waitlist shall not receive developmental disability support coordination/case management services unless a special service need (as defined in subdivision 4 of this subsection) is identified, in which case an ISP shall be developed to address the special service need. Support coordinators/case managers shall make face-to-face contact with the individual at least every 90 calendar days to monitor the special service need, and documentation is required to support such contact. The support coordinator/case manager shall assure the ISP addresses the current special service needs of the individual and shall coordinate with the Department of Medical Assistance Services designee to assure actual enrollment into the waiver upon slot availability.

2. An active individual for developmental disability support coordination/case management shall mean a person for whom there is an individual support plan (ISP), as defined in 12VAC30-122-20, that requires direct or -related individual-related contacts or communication or activity with the individual, the individual's family/caregiver, service providers, and significant others . Billing can be submitted for an active individual only for months in which direct or -related individual-related contacts, activity, or communications occur, consistent with the goals or outcomes in the individual's ISP. Face-to-face contact between the support coordinator/case manager and the individual shall occur at least every 90 calendar days in which there is an activity submitted for billing.

manager will

3. The unit of service is one month. There shall be no maximum service limits for support coordination/case management services except management services for as related to individuals residing in medical institutions or medical facilities. For these individuals, reimbursement for support coordination/case management services shall be limited to 90 days immediately preceding discharge from those settings. Support coordination/case management for individuals in a medical institution or facility may be billed for no more than two 90-day periods in a 12-month period.

4. A special service need is one that requires linkage to and temporary monitoring of those supports and services identified in the ISP to address an individual's mental health, behavioral, and medical needs or provide assistance related to an acute need that coincides with the allowable activities noted in subsection D of this section. If an activity related to the special service need is provided in a given month, then the support coordinator/case manager would be eligible for reimbursement. Once the special service need is addressed related to the specific activity identified, billing for the service shall not continue until a special service need presents again.

B. Services will be provided in the entire state.

C. Comparability of services. Services are not comparable in amount, duration, and scope. Authority of § 1915(g)(1) of the Social Security Act (Act) is invoked to provide services without regard to the requirements of § 1902(a)(10)(B) of the Act and to limit support coordination/case management providers to the community services boards or behavioral health authorities (CSBs or BHAs). CSBs or BHAs shall contract with private support coordinators/case managers for this service in accordance with subdivision F 1 of this section.

D. Definition of services. Support coordination/case management services will be provided for Medicaid-eligible individuals with developmental disability or related conditions who are on the DD Waivers waiting list for or enrolled in one of the home and community-based services DD Waivers. Support coordination/case management services that may be provided include:

1. Assessment and planning services, to include developing an ISP as defined on 12VAC30-122-20 and in accordance with the requirements of the Final Rule found at 42 CFR 441.725, which does not include performing medical and psychiatric assessment but does include referral for such assessment;

2. Linking the individual to services and supports specified in the ISP;

3. Assisting the individual directly for the purpose of locating, developing, or obtaining needed services and resources;

4. Coordinating services and service planning with other agencies and providers involved with the individual;

5. Enhancing community integration by contacting other entities to arrange community access and involvement, including opportunities to learn community living skills and to use vocational, civic, and recreational services;

6. Making collateral contacts with the individual's significant others to promote implementation of the ISP and community integration;

7. Following up and monitoring to assess ongoing progress and ensure services are delivered as outlined in the ISP and addressing any change of status; and;

8. Education and guidance that supports the individual and develops a supportive relationship that promotes the ISP.

E. Qualifications of providers.

1. CSBs or BHAs shall have current, signed provider agreements with the Department of Medical Assistance Services (DMAS) and shall directly bill DMAS for reimbursement. CSBs or BHAs shall contract with other entities to provide support coordination/case management in accordance with subdivision F 1 of this section.

2. Support coordinators/case managers shall not be (i) the direct care staff person, as defined in 12VAC30-122-20, (ii) the immediate supervisor of the direct care staff person, (iii) otherwise related by business or organization to the direct care staff person, or (iv) an immediate family member of the direct care staff person.

3. Support coordination/case management services shall not be provided to the individual by (i) parents, guardians, spouses, or any family living with the individual or (ii) parents, guardians, spouses, or any family employed by an organization that provides support coordination/case management for the individual except in cases where the family member was employed by the case management entity prior to implementation of this chapter.

4. Providers of developmental disability support coordination/case management services shall meet the following criteria:

a. The provider shall guarantee that individuals have access to emergency services on a 24-hour basis pursuant to § 37.2-500 of the Code of Virginia;

b. The provider shall demonstrate the ability to serve individuals in need of comprehensive services regardless of the individual's ability to pay or eligibility for Medicaid;

c. The provider shall have the administrative and financial management capacity to meet state and federal requirements;

d. The provider shall document and maintain individual case records in accordance with state and federal requirements; and

e. The provider shall submit the individual support plan in an electronic format in the state DD home and community-based services (HCBS) waiver management system for service authorization and data management for individuals enrolled in any DD HCBS waiver. The provider shall submit evidence of follow-up and monitoring to assess ongoing progress of the ISP, ensuring services are delivered and health and safety is maintained;

f. The provider shall participate in activities designed to safeguard participants' health and safety in accordance with approved DD HCBS waiver requirements or DBHDS licensing standards;

g. The provider shall participate in activities designed to assure ongoing compliance by DD HCBS waiver participants' providers of service subject to the Final Rule Settings Requirements found at 42 CFS 441.301(4) and as described in the approved Statewide Transition Plan; and

h. The provider shall be licensed as a support coordination/case management entity.

5. The provider shall ensure that support coordinators/case managers who provide developmental disability support coordination/case management services and were hired after September 1, 2016, shall possess a minimum of a bachelor's degree in a human services field or be a registered nurse. Support coordinators/case managers hired before September 1, 2016, who do not possess a minimum of a bachelor's degree in a human services field or are not a registered nurse may continue to provide support coordination/case management if they are employed by or contracting with an entity that has a Medicaid provider participation agreement to provide developmental disability support coordination/case management prior to February 1, 2005, and the support coordinator/case manager has maintained employment with the provider without interruption and that is documented in the personnel record.

6. In addition to the requirements in subdivision 5 of this subsection, the support coordinator/case manager shall possess developmental disability work experience or relevant education that indicates that at entry level he possesses the following knowledge, skills, and abilities that shall be documented in the employment application form or supporting documentation or during the job interview:

a. Knowledge of:

(1) The definition and causes of developmental disability and best practices in supporting individuals who have developmental disabilities;

(2) Treatment modalities and intervention techniques, such as positive behavioral supports, person-centered practices, independent living skills, training, community inclusion/employment training, supportive guidance, family education, crisis intervention, discharge planning, and service coordination;

(3) Different types of assessments and their uses in determining the specific needs of the individual with respect to his ISP;

(4) Individuals' human and civil rights;

(5) Local service delivery systems, including support services;

(6) Types of programs and services that support individuals with developmental disabilities;

(7) Effective oral, written, and interpersonal communication principles and techniques;

(8) General principles of documentation; and

(9) The service planning process and the major components of the ISP.

b. Skills in:

(1) Interviewing;

(2) Negotiating with individuals and service providers;

(3) Observing recording, and reporting and documenting an individual's behaviors;

(4) Identifying and documenting an individual's needs for resources, services, and other assistance;

(5) Identifying services within the established service system to meet the individual's needs and preferences;

(6) Coordinating the provision of services by diverse public and private providers and generic and natural supports;

(7) Analyzing and planning for the service needs of individuals with developmental disability;

(8) Formulating, writing, and implementing individual-specific support plans promote goal attainment for recipients with developmental disabilities designed to facilitate attainment of the individual's unique goals for a meaningful, quality life; and

(9) Using information from assessments, evaluations, observations, and interviews to develop and revise as needed individual support plans tools (e.g., to ensure the ISP is implemented appropriately, identify change in status, or to determine risk of crisis/hospitalization).

c. Abilities to:

(1) Demonstrate a positive regard for individuals and their families (e.g., allowing risk taking, avoiding stereotypes of people with developmental disabilities, respecting individual and family privacy, believing individuals can grow and contribute to their community);

(2) Be persistent and remain objective;

(3) Work as a team member, maintaining effective interagency and intra-agency working relationships;

(4) Work independently, performing position duties under general supervision;

(5) Communicate effectively, orally and in writing; and

(6) Establish and maintain ongoing supportive relationships.

A case manager may provide services facilitation services. In these cases, the case manager must meet all the case management provider requirements as well as the service facilitation provider requirements. Individuals and their family/caregivers, as appropriate, have the right to choose whether the case manager may provide services facilitation or to have a separate services facilitator and this choice must be clearly documented in the individual's record. If case managers are not services facilitation providers, the case manager must assist the individual and his family/caregiver, as appropriate, to locate an available services facilitator.

7. Support coordinators/case managers shall receive supervision within the employing organization. The supervisor of the support coordinator/case manager shall have either:

a. A master's degree in a human services field and one year of required documented experience working with individuals who have developmental disabilities as defined in § 37.2-100 of the Code of Virginia;

b. A registered nurse license in the Commonwealth, or hold a multistate licensure privilege and one year of documented experience working with individuals who have developmental disabilities as defined in § 37.2-100 of the Code of Virginia;

c. A bachelor's degree and two years of experience working with individuals who have developmental disabilities as defined in § 37.2-100 of the Code of Virginia;

d. A high school diploma or GED and five years of paid experience in developing, conducting, and approving assessments and ISPs as well as working with individuals who have developmental disabilities as defined in § 37.2-100 of the Code of Virginia;

e. A license to practice medicine or osteopathic medicine in the Commonwealth and one year of required documented experience working with individuals who have developmental disabilities as defined in § 37.2-100 of the Code of Virginia; or

f. Requirements as set out in the Department of Behavioral Health and Developmental Disabilities licensing regulations (12VAC35-105-1250).

8. Support coordinators/case managers shall obtain at least one hour of documented supervision at least every 90 calendar days.

9. A support coordinator/case manager shall complete a minimum of eight hours of training annually in one or more of a combination of areas described in the knowledge, skills, and abilities in subdivision 6 of this subsection and shall provide documentation to his supervisor that demonstrates that training is completed. The documentation shall be maintained by the supervisor of the support coordinator/case manager in the employee's personnel file for the purposes of utilization review. This documentation shall be provided to the Department of Medical Assistance Services and the Department of Behavioral Health and Developmental Services upon request.

F. The state assures that the provision of management support coordination/case management services will not restrict an individual's free choice of providers in violation of § 1902(a)(23) of the Act and the Final Rule at 42 CFR 441.301(c)(1)(vi).

1. To provide choice to individuals who are enrolled in the Developmental Disabilities (DD) Waivers (Building Independence (BI), Community Living (CL), and Family and Individual Supports (FIS)), CSBs or BHAs shall contract with private support coordination/case management entities to provide developmental disabilities support coordination/case management services. If there are no qualified providers in that CSB's or BHA's catchment area, then the CSB or BHA shall provide the support coordination/case management services. The CSBs or BHAs shall be the only licensed entities permitted to be reimbursed for developmental disabilities or intellectual disability support coordination/case management services. For those individuals who receive developmental disabilities support coordination/case management services:

a. The CSB or BHA that serves the individual shall be the responsible provider of support coordination/case management. This CSB or BHA shall be the provider responsible for submitting claims to the Department of Medical Assistance Services (DMAS) for reimbursement.

b. The CSB shall inform the individual that the individual has a choice with respect to the support coordination/case management services that he receives. The individual shall be informed that he can choose from among these options:

(1) The individual may have his choice of support coordinator/case manager employed by the CSB or BHA.

(2) The individual may have his choice of another CSB or BHA with which the responsible CSB or BHA provider has a memorandum of agreement if the individual or family decides not to choose is desired in the responsible CSB or BHA provider.

(3) The individual may have a choice of a designated private provider with whom the responsible CSB or BHA provider has a contract for support coordination/case management if the individual or family decides not to choose the responsible CSB or BHA provider or another CSB or BHA when there is a memorandum of agreement.

c. At any time, the individual or family may request to change their support coordinator/case manager.

2. Eligible individuals will have free choice of the providers of other medical care under the State Plan for Medical Assistance.

G. Payment for management support coordination/case management services under the does State Plan shall not duplicate payments made to public agencies or private entities under other program authorities for this same purpose.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 18, eff. July 1, 2001; amended, Virginia Register Volume 23, Issue 20, eff. July 11, 2007; Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-50-491 Substance use case management services for individuals who have a primary diagnosis of substance use disorder

A. Target group for substance use case management services for individuals who have a primary diagnosis of substance use disorder.

1. The Medicaid-eligible individual shall meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for a substance use disorder. Tobacco-related disorders or caffeine-related disorders and nonsubstance-related disorders shall not be covered. Substance use case management shall include an active individual service plan (ISP) that requires a minimum of two substance use case management service activities each month and at least one face-to-face contact with the individual at least every 90 calendar days.

2. There shall be no maximum service limits for case management services.

3. In accordance with 42 CFR 441.18(a)(8)(vii), reimbursement is allowed for case management services for Medicaid-eligible individuals who are in institutions, with the exception of individuals who are 22 years of age to 64 years of age and served in institutions of mental diseases (IMDs) and individuals of any age who are inmates of public institutions. An IMD is a facility that is primarily engaged in the treatment of mental illness and has more than 16 beds.

4. For individuals who are 22 years of age to 64 years of age, services rendered during the same month as the admission to the IMD are reimbursable as long as the service was rendered prior to the date of the admission.

5. Case management services for individuals who are younger than 22 years of age or older than 64 years of age in an IMD may be billed 30 calendar days prior to discharge as long as the case management services do not duplicate other services provided by the institution.

B. Services for substance use case management for individuals who have a primary diagnosis of substance use disorder will be provided to the entire state.

C. Comparability of services for substance use case management services for individuals who have a primary diagnosis of substance use disorder. Services are not comparable in amount, duration, or scope. Authority of § 1915(g)(1) of the Social Security Act is invoked to provide services without regard to the requirements of § 1902(a)(10)(B) of the Social Security Act.

D. Definition of substance use case management services for individuals who have a primary diagnosis of substance use disorder. Substance use case management services assist individuals and family members in accessing needed medical, psychiatric, psychological, social, educational, vocational, recovery, and other supports essential to meeting the individual's basic needs. Substance use case management is reimbursable on a monthly basis only when the minimum substance use case management service activities are met. Substance use case management does not include maintaining service waiting lists or periodically contacting or tracking individuals to determine potential service needs. Substance use case management services are to be person centered, individualized, and culturally and linguistically appropriate to meet the individual's and family member's needs.

Substance use case management service activities to be provided shall include:

1. Assessing needs and planning services to include developing a substance use case management individual service plan (ISP). The ISP shall utilize accepted placement criteria and shall be fully completed within 30 calendar days of initiation of service;

2. Enhancing community integration through increased opportunities for community access and involvement and enhancing community living skills to promote community adjustment, including, to the maximum extent possible, the use of local community resources available to the general public;

3. Making collateral contacts with the individual's significant others with properly authorized releases to promote implementation of the individual's ISP and the individual's community adjustment;

4. Linking the individual to those community supports that are most likely to promote the personal habilitative or rehabilitative, recovery, and life goals of the individual as developed in the ISP;

5. Assisting the individual directly to locate, develop, or obtain needed services, resources, and appropriate public benefits;

6. Ensuring the coordination of services and service planning within a provider agency, with other providers, and with other human service agencies and systems, such as local health and social services departments;

7. Monitoring service delivery through contacts with individuals receiving services and service providers and site and home visits to assess the quality of care and satisfaction of the individual;

8. Providing follow-up instruction, education, and counseling to guide the individual and develop a supportive relationship that promotes the ISP;

9. Advocating for the individual in response to the individual's changing needs based on changes in the ISP;

10. Planning for transitions in the individual's life;

11. Knowing and monitoring the individual's health status, any medical condition, and medications and potential side effects and assisting the individual in accessing primary care and other medical services, as needed; and

12. Understanding the capabilities of services to meet the individual's identified needs and preferences and to serve the individual without placing the individual, other participants, or staff at risk of serious harm.

E. Qualifications of providers of substance use case management services for individuals who have a primary diagnosis of substance use disorder.

1. The provider of substance use case management services must meet the following criteria:

a. The enrolled provider must have the administrative and financial management capacity to meet state and federal requirements;

b. The enrolled provider must have the ability to document and maintain individual case records in accordance with state and federal requirements; and

c. The enrolled provider must be licensed by the Department of Behavioral Health and Developmental Services (DBHDS) as a provider of substance abuse case management services.

2. Providers may bill Medicaid for substance use case management only when the services are provided by a professional who meets at least one of the following criteria:

a. At least a bachelor's degree in social work, psychology, psychiatric rehabilitation, sociology, counseling, vocational rehabilitation, or human services counseling and at least either (i) one year of substance use-related direct experience providing services to individuals with a diagnosis of substance use disorder or (ii) a minimum of one year of clinical experience working with individuals with co-occurring diagnoses of substance use disorder and mental illness;

b. Licensure by the Commonwealth as a registered nurse with (i) at least one year of substance use-related direct experience providing services to individuals with a diagnosis of substance use disorder or (ii) a minimum of one year of clinical experience working with individuals with co-occurring diagnoses of substance use disorder and mental illness; or

c. Certification as a Board of Counseling Certified Substance Abuse Counselor (CSAC), CSAC-Supervisee, or CSAC-Assistant under clinical supervision as defined in 18VAC115-30-10.

F. The state ensures that the provision of substance use case management services will not restrict an individual's free choice of providers in violation of § 1902(a)(23) of the Social Security Act.

1. Eligible individuals shall have free choice of the providers of substance use case management services.

2. Eligible individuals shall have free choice of the providers of other services under the plan.

G. Payment for substance use case management or substance use care coordination services under the plan does not duplicate payments for other case management made to public agencies or private entities under other Title XIX program authorities for this same purpose.

H. The state ensures that the individual will not be compelled to receive substance use case management services, condition receipt of case management services on the receipt of other Medicaid services, or condition receipt of other Medicaid services on receipt of case management services.

I. The state ensures that providers of substance use case management services do not exercise the agency's authority to authorize or deny the provision of other services under the plan.

J. The state ensures that substance use case management is only provided by and reimbursed to community case management providers.

K. The state ensures that substance use case management does not include the following:

1. The direct delivery of an underlying medical, educational, social, or other service to which an eligible individual has been referred.

2. Activities for which an individual may be eligible that are integral to the administration of another nonmedical program, except for case management that is included in an individualized education program or individualized family service plan consistent with § 1903(c) of the Social Security Act.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 26, Issue 8, eff. January 21, 2010; amended, Virginia Register Volume 33, Issue 12, eff. April 1, 2017; Volume 41, Issue 7, eff. January 2, 2025.

Part V Expanded Prenatal Care Services

12VAC30-50-510 Requirements and limits applicable to specific services: expanded prenatal care services

A. Comparability of services: Services are not comparable in amount, duration and scope. Authority of § 9501(b) of COBRA 1985 allows an exception to provide service to pregnant women without regard to the requirements of § 1902(a)(10)(B).

B. Definition of services: Expanded prenatal care services will offer a more comprehensive prenatal care services package to improve pregnancy outcome. The expanded prenatal care services provider may perform the following services:

1. Patient education. Includes six classes of education for pregnant women in a planned, organized teaching environment including but not limited to topics such as body changes, danger signals, substance abuse, labor and delivery information, and courses such as planned parenthood, Lamaze, smoking cessation, and child rearing. Instruction must be rendered by Medicaid certified providers who have appropriate education, license, or certification.

2. Homemaker. Includes those services necessary to maintain household routine for pregnant women, primarily in third trimester, who need bed rest. Services include, but are not limited to, light housekeeping, child care, laundry, shopping, and meal preparation. Must be rendered by Medicaid certified providers.

3. Nutrition. Includes nutritional assessment of dietary habits, and nutritional counseling and counseling follow-up. All pregnant women are expected to receive basic nutrition information from their medical care providers or the WIC Program. Must be provided by a Registered Dietitian (R.D.) or a person with a master's degree in nutrition, maternal and child health, or clinical dietetics with experience in public health, maternal and child nutrition, or clinical dietetics.

4. Blood glucose meters. Effective on and after July 1, 1993, blood glucose test products shall be provided when they are determined by the physician to be medically necessary for pregnant women suffering from a condition of diabetes which is likely to negatively affect their pregnancy outcomes. The women authorized to receive a blood glucose meter must also be referred for nutritional counseling. Such products shall be provided by Medicaid enrolled durable medical equipment providers.

5. Addiction and recovery treatment services shall be covered in expanded prenatal care services consistent with 12VAC30-130-5000 et seq.

C. Qualified providers. Providers of addiction and recovery treatment services shall meet the requirements of 12VAC30-130-5000 et seq.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-03-3.1103, eff. July 1, 1993; amended, Virginia Register Volume 14, Issue 7, eff. January 22, 1998; Volume 20, Issue 7, eff. February 1, 2004; Volume 33, Issue 12, eff. April 1, 2017.

Part VI Drugs or Drug Categories

12VAC30-50-520 Drugs or drug categories which are not covered

A. Agents when used for anorexia or weight gain. Coverage of anorexiants for other than weight loss requires medical justification. FDA-approved drug therapies and agents for weight loss, when preauthorized, will be covered for recipients who meet the strict disability standards for obesity established by the Social Security Administration in effect on April 7, 1999, and whose condition is certified as life threatening, consistent with Department of Medical Assistance Services' medical necessity requirements, by the treating physician.

B. Agents when used for cosmetic purposes or hair growth.

1. Minoxidil shall not be covered when prescribed for hair growth or other cosmetic purposes.

2. Agents containing hydroquinone or its derivatives which are used solely for depigmentation of the skin.

C. Agents used to promote fertility.

D. Expired drugs. Drugs dispensed past the labeled expiration date.

E. DESI Drugs. The Program shall not provide reimbursement for drugs determined by the Food and Drug Administration (FDA) to lack substantial evidence of effectiveness.

F. Nonlegend drugs. Nonlegend drugs, with those exceptions shown in 12VAC30-50-100 et seq., shall not be covered.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-03-3.1105, eff. April 1, 1993; amended, Virginia Register Volume 13, Issue 18, eff. July 1, 1997; Volume 15, Issue 23, eff. September 1, 1999.

Part VII Transportation

12VAC30-50-530 Methods of providing transportation

A. DMAS will ensure necessary transportation for recipients to and from providers of covered medical services. DMAS shall cover transportation to covered medical services under the following circumstances:

1. Emergency air, ambulance transportation, and all other modes of transportation, shall be covered as medical services under 42 CFR 431.53 and any other applicable federal Medicaid regulations. These modes include, but shall not be limited to, nonemergency air travel, nonemergency ground ambulance, stretcher vans, wheelchair vans, common user bus (intra-city and inter-city), volunteer/registered drivers, and taxicabs. DMAS may contract directly with providers of transportation or with brokers of transportation services, or both. DMAS may require that brokers not have a financial interest in transportation providers with whom they contract.

2. Medicaid provided transportation shall only be available when recipients have no other means of transportation available.

3. Recipients shall be furnished transportation services that are the most economical to adequately meet the recipients' medical needs.

4. Ambulances, wheelchair vans, taxicabs, and other modes of transportation must be licensed to provide services in the Commonwealth by the appropriate state or local licensing agency, or both. Volunteer/registered drivers must be licensed to operate a motor vehicle in the Commonwealth and must maintain automobile insurance.

5. DMAS-covered school transportation is described at 12VAC30-50-130 C. Vehicles and drivers providing the transportation shall be in compliance with applicable laws and regulations.

B. DMAS will ensure necessary nonemergency transportation for full-benefit, dual eligible recipients to obtain medically necessary, noncovered Medicare Part D prescription drugs.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-02-3.1400, eff. January 1, 1993; amended, Virginia Register Volume 17, Issue 12, eff. July 2, 2001; Volume 20, Issue 1, eff. October 22, 2003; Volume 21, Issue 22, eff. August 10, 2005; Volume 23, Issue 11, eff. March 7, 2007; Volume 25, Issue 5, eff. December 10, 2008.

Part VIII Organ Transplant Services

12VAC30-50-540 Kidney transplantation (KT)

A. Patient selection criteria for provision of kidney transplantation. Transplantation of the kidney is a surgical treatment whereby a diseased kidney is replaced by a healthy organ. Pre-authorization is required. The following patient selection criteria shall apply for the consideration of all approvals for coverage and reimbursement for kidney transplantation.

1. Current medical therapy has failed and patient has failed to respond to appropriate conservative management;

2. The patient does not have other systemic disease including but not limited to the following:

a. Reversible renal conditions;

b. Major extra-renal complications (malignancy, systemic disease, cerebral cardio-arterial disease);

c. Active infection;

d. Severe malnutrition; or

e. Pancytopenia.

3. The patient is not in both an irreversible terminal state and on a life support system;

4. Adequate supervision will be provided to assure there will be strict adherence to the medical regimen which is required;

5. The KT is likely to prolong life and restore a range of physical and social function suited to activities of daily living;

6. A facility with appropriate expertise has evaluated the patient, and has indicated willingness to undertake the procedure;

7. The patient does not have multiple uncorrectable severe major system congenital anomalies;

8. Failure to meet (1) through (7) above shall result in denial of pre-authorization and coverage for the requested kidney transplant procedures.

B. Facility selection criteria for kidney transplantation (KT). For medical facility to qualify as an approved Virginia Medicaid provider for performing kidney transplants, the following conditions must be met:

1. The facility has available expertise in immunology, infectious disease, pathology, pharmacology, and anesthesiology;

2. The KT program staff has extensive experience and expertise in the medical and surgical treatment of renal disease;

3. Transplant surgeons on the staff have been trained in the KT technique at an institution with a well established KT program;

4. The transplantation program has adequate services to provide specialized psychosocial and social support for patients and families;

5. Adequate blood bank support services are present and available;

6. Satisfactory arrangements exist for donor procurement services;

7. The institution is committed to a program of at least 25 KTs a year;

8. The center has a consistent, equitable, and practical protocol for selection of patients (at a minimum, the DMAS Patient Selection Criteria must be met and adhered to);

9. The center has the capacity and commitment to conduct a systematic evaluation of outcome and cost;

10. In addition to hospital administration and medical staff endorsement, hospital staff support also exists for such a program;

11. The hospital has an active, ongoing renal dialysis service;

12. The hospital has access to staff with extensive skills in tissue typing, immunological and immunosuppressive techniques;

13. Initial approval as KT center requires performance of 25 KTs within the most recent 12 months, with a one year survival rate of at least 90%. Centers that fail to meet this requirement during the first year will be given a one-year conditional approval. Failure to meet the volume requirement following the conditional approval will result in loss of approval.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-02-3.1500, eff. July 19, 1993; amended, Virginia Register Volume 10, Issue 18, eff. July 14, 1994; Volume 14, Issue 18, eff. July 1, 1998.

12VAC30-50-550 Corneal transplantation

A. Patient selection criteria for provision of corneal transplantation (CT). Transplantation of the cornea is a surgical treatment whereby a diseased cornea is replaced by a healthy organ. While pre-authorization is not required, the following patient selection criteria shall apply for the consideration of all approvals for reimbursement for cornea transplantation.

1. Current medical therapy has failed and will not prevent progressive disability;

2. The patient is suffering from one of the following conditions:

a. Post-cataract surgical decompensation,

b. Corneal dystrophy,

c. Post-traumatic scarring,

d. Keratoconus, or

e. Aphakia Bullous Keratopathy;

3. Adequate supervision will be provided to assure there will be strict adherence by the patient to the long term medical regimen which is required;

4. The CT is likely to restore a range of physical and social function suited to activities of daily living;

5. The patient is not in both an irreversible terminal state and on a life support system;

6. The patient does not have untreatable cancer, bacterial, fungal, or viral infection;

7. The patient does not have the following eye conditions:

a. Trichiasis,

b. Abnormal lid brush and/or function,

c. Tear film deficiency,

d. Raised transocular pressure,

e. Intensive inflammation, and

f. Extensive neo-vascularization.

B. Facility selection criteria for cornea transplantation (CT). For medical facility to qualify as an approved Medicaid provider for performing cornea transplants, the following conditions must be met:

1. The facility has available expertise in immunology, infectious disease, pathology, pharmacology, and anesthesiology;

2. The CT program staff has extensive experience and expertise in the medical and surgical treatment of eye disease;

3. Transplant surgeons on the staff have been trained in the CT technique at an institution with a well established CT program;

4. The transplantation program has adequate services to provide social support for patients and families;

5. Satisfactory arrangements exist for donor procurement services;

6. The institution is committed to a program of eye surgery;

7. The center has a consistent, equitable, and practical protocol for selection of patients (at a minimum, the DMAS Patient Selection Criteria must be met and adhered to);

8. The center has the capacity and commitment to conduct a systematic evaluation of outcome and cost;

9. In addition to hospital administration and medical staff endorsement, hospital staff support also exists for such a program;

10. Initial approval as CT center requires performance of corneal transplant surgery, with a one year graft survival rate of at least 75%. Centers that fail to meet this requirement during the first year will be given a one-year conditional approval. Failure to meet this requirement following the conditional approval will result in loss of approval.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 14, Issue 18, eff. July 1, 1998.

12VAC30-50-560 Liver, heart, lung, allogeneic and autologous bone marrow transplantation

A. Patient selection criteria for provision of liver, heart, allogeneic and autologous bone marrow transplantation.

1. The following general conditions shall apply to these services:

a. Coverage shall not be provided for procedures that are provided on an investigational or experimental basis.

b. There must be no effective alternative medical or surgical therapies available with outcomes that are at least comparable.

c. The transplant procedure and application of the procedure in treatment of the specific condition for which it is proposed have been clearly demonstrated to be medically effective.

d. Prior authorization by the Department of Medical Assistance Services (DMAS) is required. The prior authorization request must contain the information and documentation as required by DMAS.

2. The following patient selection criteria shall apply for the consideration of authorization and coverage and reimbursement:

The patient selection criteria of the transplant center where the surgery is to be performed shall be used in determining whether the patient is appropriate for selection for the procedure. Transplant procedures will be preauthorized only if the selection of the patient adheres to the transplant center's patient selection criteria, based upon review by DMAS of information submitted by the transplant team or center.

The recipient's medical condition shall be reviewed by the transplant team or program according to the transplant facility's patient selection criteria for that procedure and the recipient shall be determined by the team to be an appropriate transplant candidate. Patient selection criteria used by the transplant center shall include, but not necessarily be limited to, the following:

a. Current medical therapy has failed and the patient has failed to respond to appropriate therapeutic management;

b. The patient is not in an irreversible terminal state, and

c. The transplant is likely to prolong life and restore a range of physical and social function suited to activities of daily living.

B. Facility selection criteria for liver, heart, allogeneic and autologous bone marrow transplantation.

1. The following general conditions shall apply:

a. Procedures may be performed out of state only when the authorized transplant cannot be performed in the Commonwealth because the service is not available or, due to capacity limitations, the transplant can not be performed in the necessary time period.

b. Criteria applicable to transplantation services and centers in the Commonwealth also apply to out-of-state transplant services and facilities.

2. To qualify for coverage, the facility must meet, but not necessarily be limited to, the following criteria:

a. The transplant program staff has demonstrated expertise and experience in the medical and surgical treatment of the specific transplant procedure;

b. The transplant surgeons have been trained in the specific transplant technique at an institution with a well established transplant program for the specific procedure;

c. The facility has expertise in immunology, infectious disease, pathology, pharmacology, and anesthesiology;

d. The facility has staff or access to staff with expertise in tissue typing, immunological and immunosuppressive techniques;

e. Adequate blood bank support services are available;

f. Adequate arrangements exist for donor procurement services;

g. Current full membership in the United Network for Organ Sharing, for the facilities where solid organ transplants are performed;

h. Membership in a recognized bone marrow accrediting or registry program for bone marrow transplantation programs;

i. The transplant facility or center can demonstrate satisfactory transplantation outcomes for the procedure being considered;

j. Transplant volume at the facility is consistent with maintaining quality services;

k. The transplant center will provide adequate psychosocial and social support services for the transplant recipient and family.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 14, Issue 18, eff. July 1, 1998; amended, Virginia Register Volume 16, Issue 18, eff. July 1, 2000.

12VAC30-50-570 High dose chemotherapy and bone marrow/stem cell transplantation (coverage for persons over 21 years of age)

A. Patient selection criteria for high dose chemotherapy and bone marrow/stem cell transplantation (coverage for persons over 21 years of age).

1. The following general conditions shall apply to these services:

a. This must be the most effective medical therapy available yielding outcomes that are at least comparable to other therapies.

b. The transplant procedure and application of the procedure in treatment of the specific condition for which it is proposed have been clearly demonstrated to be medically effective.

c. Prior authorization by the Department of Medical Assistance Services (DMAS) is required. The prior authorization request must contain the information and documentation as required by DMAS. The nearest approved and appropriate facility will be considered.

2. The following patient selection criteria shall apply for the consideration of authorization and coverage and reimbursement for individuals who have been diagnosed with lymphoma, breast cancer, leukemia, or myeloma and have been determined by the treating health care provider to have a performance status sufficient to proceed with such high dose chemotherapy and bone marrow/stem cell transplant:

a. The patient selection criteria of the transplant center where the treatment is to be performed shall be used in determining whether the patient is appropriate for selection for the procedure. Transplant procedures will be preauthorized only if the selection of the patient adheres to the transplant center's patient selection criteria based upon review by DMAS of information submitted by the transplant team or center.

b. The recipient's medical condition shall be reviewed by the transplant team or program according to the transplant facility's patient selection criteria for that procedure and the recipient shall be determined by the team to be an appropriate transplant candidate. Patient selection criteria used by the transplant center shall include, but not necessarily be limited to, the following:

(1) The patient is not in an irreversible terminal state (as demonstrated in the facility's patient selection criteria); and

(2) The transplant is likely to prolong life and restore a range of physical and social functions suited to activities of daily living.

B. Facility selection criteria for high dose chemotherapy and bone marrow/stem cell transplantation for individuals diagnosed with lymphoma, breast cancer, leukemia, or myeloma.

1. The following general conditions shall apply:

a. Unless it is cost effective and medically appropriate, procedures may be performed out of state only when the authorized transplant cannot be performed in the Commonwealth because the service is not available or, due to capacity limitations, the transplant cannot be performed in the necessary time period.

b. Criteria applicable to transplantation services and centers in the Commonwealth also apply to out-of-state transplant services and facilities.

2. To qualify for coverage, the facility must meet, but not necessarily be limited to, the following criteria:

a. The transplant program staff has demonstrated expertise and experience in the medical treatment of the specific transplant procedure;

b. The transplant physicians have been trained in the specific transplant technique at an institution with a well established transplant program for the specific procedure;

c. The facility has expertise in immunology, infectious disease, pathology, pharmacology, and anesthesiology;

d. The facility has staff or access to staff with expertise in tissue typing, immunological and immunosuppressive techniques;

e. Adequate blood bank support services are available;

f. Adequate arrangements exist for donor procurement services;

g. The facility has a membership in a recognized bone marrow accrediting or registry program for bone marrow transplantation programs;

h. The transplant facility or center can demonstrate satisfactory transplantation outcomes for the procedure being considered;

i. Transplant volume at the facility is consistent with maintaining quality services; and

j. The transplant center will provide adequate psychosocial and social support services for the transplant recipient and family.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 14, Issue 18, eff. July 1, 1998; amended, Virginia Register Volume 15, Issue 18, eff. July 1, 1999; Volume 16, Issue 18, eff. July 1, 2000.

12VAC30-50-580 Other medically necessary transplantation procedures that are determined to not be experimental or investigational (coverage for persons younger ...

A. Patient selection criteria for any other medically necessary transplantation procedures that are determined to not be experimental or investigational.

1. The following general conditions shall apply to these services:

a. Coverage shall not be provided for procedures that are provided on an investigational or experimental basis.

b. There must be no effective alternative medical or surgical therapies available with outcomes that are at least comparable.

c. The transplant procedure and application of the procedure in treatment of the specific condition for which it is proposed have been clearly demonstrated to be medically effective and not experimental or investigational.

d. Prior authorization by the Department of Medical Assistance Services is required. The prior authorization request must contain the information and documentation as required by DMAS.

2. The following patient selection criteria shall apply for the consideration of authorization and coverage and reimbursement:

a. The patient must be under 21 years of age at time of surgery.

b. The patient selection criteria of the transplant center where the surgery is to be performed shall be used in determining whether the patient is appropriate for selection for the procedure. Transplant procedures will be preauthorized only if the selection of the patient adheres to the transplant center's patient selection criteria, based upon review by DMAS of information submitted by the transplant team or center.

The recipient's medical condition shall be reviewed by the transplant team or program according to the transplant facility's patient selection criteria for that procedure and the recipient shall be determined by the team to be an appropriate transplant candidate. Patient selection criteria used by the transplant center shall include, but not necessarily be limited to, the following:

(1) Current medical therapy has failed and the patient has failed to respond to appropriate therapeutic management;

(2) The patient is not in an irreversible terminal state, and

(3) The transplant is likely to prolong life and restore a range of physical and social function suited to activities of daily living.

B. Facility selection criteria.

1. The following general conditions shall apply:

a. Procedures may be performed out of state only when the authorized transplant cannot be performed in the Commonwealth because the service is not available or, due to capacity limitations, the transplant cannot be performed in the necessary time period.

b. Criteria applicable to transplantation services and centers in the Commonwealth also apply to out-of-state transplant services and facilities.

2. To qualify for coverage, the facility must meet, but not necessarily be limited to, the following criteria:

a. The transplant program staff has demonstrated expertise and experience in the medical and surgical treatment of the specific transplant procedure;

b. The transplant surgeons have been trained in the specific transplant technique at an institution with a well established transplant program for the specific procedure;

c. The facility has expertise in immunology, infectious disease, pathology, pharmacology, and anesthesiology;

d. The facility has staff or access to staff with expertise in tissue typing, immunological and immunosuppressive techniques;

e. Adequate blood bank support services are available;

f. Adequate arrangements exist for donor procurement services;

g. Current full membership in the United Network for Organ Sharing, for the facilities where solid organ transplants are performed;

h. Membership in a recognized bone marrow accrediting or registry program for bone marrow transplantation programs;

i. The transplant facility or center can demonstrate satisfactory transplantation outcomes for the procedure being considered;

j. Transplant volume at the facility is consistent with maintaining quality services;

k. The transplant center will provide adequate psychosocial and social support services for the transplant recipient and family.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 18, eff. July 1, 2000.

Part IX Commonwealth Coordinated Care Program [Repealed]

12VAC30-50-600 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 33, Issue 23, eff. August 9, 2017; repealed, Virginia Register Volume 37, Issue 24, eff. September 2, 2021.

Part X Alternative Benefit Plan

12VAC30-50-610 Alternative benefit plan: Medicaid expansion

A. The Commonwealth provides alternative benefits to the adult group (defined in § 1902(a)(10)(A)(i)(VIII) of the Social Security Act) under the coverage option under § 1937 of the Social Security Act (42 USC § 301 et seq.) approved by the Secretary of Health and Human Services. Enrollment is mandatory for individuals in the adult group, and the alternative benefit package shall be available statewide.

B. In developing the benefit package for the alternative benefit plan, the Commonwealth reviewed:

1. Benefits in its approved State Plan as a "benchmark benefit package";

2. The largest plan by enrollment of the three largest small-group insurance products in the small-group market as the "base benchmark plan"; and

3. Essential health benefits.

C. Alternative benefit plan services.

1. The alternative benefit plan includes all Medicaid State Plan services, including essential health benefits.

2. The essential health benefits included in the alternative benefit plan are ambulatory patient services; emergency services; hospitalization; maternity and newborn care; mental health and substance use disorder services, including behavioral health treatment; prescription drugs; rehabilitative and habilitative services and devices; laboratory services; preventive and wellness services; and chronic disease management. Pediatric services, including oral and vision care, are essential health benefits that are not covered for adults.

D. The Commonwealth will use both managed care and fee-for-service delivery systems for the alternative benefit plan.

1. The managed care delivery system is the same as the CMS-approved § 1915(b) managed care waivers. The fee-for-service delivery system is the traditional, state-managed system.

2. For each benefit provided under an alternative benefit plan that is not provided through managed care, the Commonwealth will use the payment methodology in its approved State Plan (i.e., 12VAC30-70, 12VAC30-80, and 12VAC30-90).

E. Individuals who have cost-effective group health plans described in § 1906 of the Social Security Act or qualified employer-sponsored plans described in § 1906A of the Social Security Act may request to receive coverage through the Health Insurance Premium Payment program.

F. Any cost sharing described in Attachment 4.18-A of the State Plan (12VAC30-20-150) applies to the alternative benefit plan.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 38, Issue 10, eff. February 17, 2022.

Chapter 70 Methods and Standards for Establishing Payment Rates; In-Patient Hospital Care

Part I Per Diem Methodology

12VAC30-70-10 Effect of participation in Health Insurance for the Aged program

For each hospital also participating in the Health Insurance for the Aged program under Title XVIII of the Social Security Act, the state agency will apply the standards, cost reporting period, cost reimbursement principles, and method of cost apportionment currently used in computing reimbursement to such a hospital under Title XVIII of the Act, except that the inpatient routine service costs for medical assistance recipients will be determined subsequent to the application of the Title XVIII method of apportionment, and the calculation will exclude the applicable Title XVIII inpatient routine service charges or patient days as well as Title XVIII inpatient routine service cost.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR Part 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-4.1910, §I, eff. July 1, 1989.

12VAC30-70-20 Standards applied to non-participants in Title XVIII programs

For each hospital not participating in the Program under Title XVIII of the Act, the state agency will apply the standards and principles described in 42 CFR 447.250 and either (a) one of the available alternative cost apportionment methods in 42 CFR 447.250, or (b) the "Gross RCCAC method" of cost apportionment applied as follows: For a reporting period, the total allowable hospital inpatient charges; the resulting percentage is applied to the bill of each inpatient under the Medical Assistance Program.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR Part 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-4.1910, §II, eff. July 1, 1989.

12VAC30-70-30 Limitations of Medical Assistance Program payment; Medicare reimbursement principles

For either participating or nonparticipating facilities, the Medical Assistance Program will pay no more in the aggregate for inpatient hospital services that the amount it is estimated would be paid for the services under the Medicare principles of reimbursement, as set forth in 42 CFR 447.253(b)(2), and/or lesser of reasonable cost or customary charges in 42 CFR 447.250.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR Part 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-4.1910, §III, eff. July 1, 1989.

12VAC30-70-40 Payment of reasonable costs based on other methods

The state agency will apply the standards and principles as described in the state's reimbursement plan approved by the Secretary, HHS on a demonstration or experimental basis for the payment of reasonable costs by methods other than those described in 12VAC30-70-10 and 12VAC30-70-20.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR Part 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-4.1910, §IV, eff. July 1, 1989.

12VAC30-70-50 Hospital reimbursement system

The reimbursement system for hospitals includes the following components:

A. Hospitals were grouped by classes according to number of beds and urban versus rural. (Three groupings for rural - 0 to 100 beds, 101 to 170 beds, and over 170 beds; four groupings for urban - 0 to 100, 101 to 400, 401 to 600, and over 600 beds.) Groupings are similar to those used by the Centers for Medicare and Medicaid Services in determining routine cost limitations.

B. Prospective reimbursement ceilings on allowable operating costs were established as of July 1, 1982, for each grouping. Hospitals with a fiscal year end after June 30, 1982, were subject to the new reimbursement ceilings.

1. The calculation of the initial group ceilings as of July 1, 1982, was based on available, allowable cost data for hospitals in calendar year 1981. Individual hospital operating costs were advanced by a reimbursement escalator from the hospital's year end to July 1, 1982. After this advancement, the operating costs were standardized using SMSA wage indices, and a median was determined for each group. These medians were readjusted by the wage index to set an actual cost ceiling for each SMSA. Therefore, each hospital grouping has a series of ceilings representing one of each SMSA area. The wage index is based on those used by HCFA in computing its Market Basket Index for routine cost limitations.

2. Effective July 1, 1986, and until June 30, 1988, providers subject to the prospective payment system of reimbursement had their prospective operating cost rate and prospective operating cost ceiling computed using a new methodology. This method uses an allowance for inflation based on the percent of change in the quarterly average of the Medical Care Index of the Chase Econometrics - Standard Forecast determined in the quarter in which the provider's new fiscal year began.

3. The prospective operating cost rate is based on the provider's allowable cost from the most recent filed cost report, plus the inflation percentage add-on.

4. The prospective operating cost ceiling is determined by using the base that was in effect for the provider's fiscal year that began between July 1, 1985, and June 1, 1986. The allowance for inflation percent of change for the quarter in which the provider's new fiscal year began is added to this base to determine the new operating cost ceiling. This new ceiling was effective for all providers on July 1, 1986. For subsequent cost reporting periods beginning on or after July 1, 1986, the last prospective operating rate ceiling determined under this new methodology will become the base for computing the next prospective year ceiling.

5. Effective on and after July 1, 1988, and until June 30, 1989, for providers subject to the prospective payment system, the allowance for inflation shall be based on the percent of change in the moving average of the Data Resources, Incorporated Health Care Cost HCFA-Type Hospital Market Basket determined in the quarter in which the provider's new fiscal year begins. Such providers shall have their prospective operating cost rate and prospective operating cost ceiling established in accordance with the methodology which became effective July 1, 1986. Rates and ceilings in effect July 1, 1988, for all such hospitals shall be adjusted to reflect this change.

6. Effective on or after July 1, 1989, for providers subject to the prospective payment system, the allowance for inflation shall be based on the percent of change in the Virginia moving average values as compiled and published by Global Insight (or its successor) determined in the quarter in which the provider's new fiscal year begins. Such providers shall have their prospective operating cost rate and prospective operating cost ceiling established in accordance with the methodology which became effective July 1, 1986. Rates and ceilings in effect July 1, 1989, for all such hospitals shall be adjusted to reflect this change.

7. Effective on and after July 1, 1992, for providers subject to the prospective payment system, the allowance for inflation, as described in this section, which became effective on July 1, 1989, shall be converted to an escalation factor by adding two percentage points, (200 basis points) to the then current allowance for inflation. The escalation factor shall be applied in accordance with the inpatient hospital reimbursement methodology in effect on June 30, 1992. On July 1, 1992, the conversion to the new escalation factor shall be accomplished by a transition methodology which, for non-June 30 year end hospitals, applies the escalation factor to escalate their payment rates for the months between July 1, 1992, and their next fiscal year ending on or before May 31, 1993.

Effective July 1, 2009, the escalation factor shall be equal to the allowance for inflation.

Effective July 1, 2010, through June 30, 2012, the escalation factor shall be zero. In addition, ceilings shall remain at the same level as the ceilings for long stay hospitals with fiscal year's end of June 30, 2010.

Effective July 1, 2012, through June 30, 2013, the escalation factor for inpatient hospitals, including long stay hospitals, shall be 2.6%.

Effective July 1, 2013, through June 30, 2016, the escalation factor for inpatient hospitals, including long stay hospitals, shall be 0.0%.

8. The new method will still require comparison of the prospective operating cost rate to the prospective operating ceiling. The provider is allowed the lower of the two amounts subject to the lower of cost or charges principles.

C. Subsequent to June 30, 1992, the group ceilings shall not be recalculated on allowable costs, but shall be updated by the escalator factor.

D. Prospective rates for each hospital shall be based upon the hospital's allowable costs plus the escalator factor, or the appropriate ceilings, or charges; whichever is lower. Except to eliminate costs that are found to be unallowable, no retrospective adjustment shall be made to prospective rates.

Capital and education costs approved pursuant to PRM-15 (§ 400), shall be considered as pass throughs and not part of the calculation. Capital cost is reimbursed the percentage of allowable cost specified in 12VAC30-70-271.

E. An incentive plan should be established whereby a hospital will be paid on a sliding scale, percentage for percentage, up to 10.5% of the difference between allowable operating costs and the appropriate per diem group ceiling when the operating costs are below the ceilings. The incentive should be calculated based on the annual cost report. Effective for dates of service July 1, 2010, through September 30, 2010, the incentive plan shall be eliminated.

F. Disproportionate share hospitals (DSH) defined.

Prior to July 1, 2014, the following criteria shall be met before a hospital is determined to be eligible for a disproportionate share pay. Effective July 1, 2014, the payment methodology for DSH is defined in 12VAC30-70-301.

1. Criteria.

a. A Medicaid inpatient utilization rate in excess of 10.5% for hospitals receiving Medicaid payments in the Commonwealth, or a low-income patient utilization rate exceeding 25% (as defined in the Omnibus Budget Reconciliation Act of 1987 and as amended by the Medicare Catastrophic Coverage Act of 1988); and

b. At least two obstetricians with staff privileges at the hospital who have agreed to provide obstetric services to individuals entitled to such services under a State Medicaid plan. In the case of a hospital located in a rural area (that is, an area outside of a Metropolitan Statistical Area, as defined by the Executive Office of Management and Budget), the term "obstetrician" includes any physician with staff privileges at the hospital to perform nonemergency obstetric procedures.

c. Subdivision 1 b of this subsection does not apply to a hospital:

(1) At which the inpatients are predominantly individuals under 18 years of age; or

(2) Which does not offer nonemergency obstetric services as of December 21, 1987.

2. Payment adjustment.

a. Hospitals which have a disproportionately higher level of Medicaid patients shall be allowed a disproportionate share payment adjustment based on the type of hospital and on the individual hospital's Medicaid utilization. There shall be two types of hospitals: (i) Type One, consisting of state-owned teaching hospitals, and (ii) Type Two, consisting of all other hospitals. The Medicaid utilization shall be determined by dividing the number of utilization Medicaid inpatient days by the total number of inpatient days. Each hospital with a Medicaid utilization of over 10.5%shall receive a disproportionate share payment adjustment.

b. For Type One hospitals, the disproportionate share payment adjustment shall be equal to the product of (i) the hospital's Medicaid utilization in excess of 10.5% times 11, times (ii) the lower of the prospective operating cost rate or ceiling. For Type Two hospitals, the disproportionate share payment adjustment shall be equal to the product of (i) the hospital's Medicaid utilization in excess of 10.5% times (ii) the lower of the prospective operating cost rate or ceiling.

c. No payments made under subdivision 1 or 2 of this subsection shall exceed any applicable limitations upon such payments established by federal law or regulations.

G. Outlier adjustments.

1. DMAS shall pay to all enrolled hospitals an outlier adjustment in payment amounts for medically necessary inpatient hospital services provided on or after July 1, 1991, involving exceptionally high costs for individuals under one year of age.

2. DMAS shall pay to disproportionate share hospitals (as defined in subsection F of this section) an outlier adjustment in payment amounts for medically necessary inpatient hospital services provided on or after July 1, 1991, involving exceptionally high costs for individuals under six years of age.

3. The outlier adjustment calculation.

a. Each eligible hospital which desires to be considered for the adjustment shall submit a log which contains the information necessary to compute the mean of its Medicaid per diem operating cost of treating individuals identified in subdivision 1 or 2 of this subsection. This log shall contain all Medicaid claims for such individuals, including, but not limited to: (i) the patient's name and Medicaid identification number; (ii) dates of service; (iii) the remittance date paid; (iv) the number of covered days; and (v) total charges for the length of stay. Each hospital shall then calculate the per diem operating cost (which excludes capital and education) of treating such patients by multiplying the charge for each patient by the Medicaid operating cost-to-charge ratio determined from its annual cost report.

b. Each eligible hospital shall calculate the mean of its Medicaid per diem operating cost of treating individuals identified in subdivision 1 or 2 of this subsection.

c. Each eligible hospital shall calculate its threshold for payment of the adjustment, at a level equal to two and one-half standard deviations above the mean or means calculated in subdivision 3 a (ii) of this subsection.

d. DMAS shall pay as an outlier adjustment to each eligible hospital all per diem operating costs which exceed the applicable threshold or thresholds for that hospital.

4. Pursuant to 12VAC30-50-100, there is no limit on length of time for medically necessary stays for individuals under six years of age. This section provides that consistent with 42 CFR 441.57, payment of medical assistance services shall be made on behalf of individuals under 21 years of age, who are Medicaid eligible, for medically necessary stays in acute care facilities in excess of 21 days per admission when such services are rendered for the purpose of diagnosis and treatment of health conditions identified through a physical examination. Medical documentation justifying admission and the continued length of stay must be attached to or written on the invoice for review by medical staff to determine medical necessity. Medically unjustified days in such admissions will be denied.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-02-4.1910, §V, eff. July 1, 1994; amended, Virginia Register Volume 13, Issue 1, eff. November 1, 1996; Volume 26, Issue 12, eff. March 17, 2010; Volume 26, Issue 19, eff. July 1, 2010; Volume 27, Issue 15, eff. April 27, 2011; Volume 27, Issue 19, eff. July 1, 2011; Volume 29, Issue 23, eff. August 14, 2013; Volume 33, Issue 19, eff. June 29, 2017.

12VAC30-70-60 Establishment of reasonable and adequate payment rates; cost reporting

In accordance with Title 42 §§ 447.250 through 447.272 of the Code of Federal Regulations which implements § 1902(a)(13)(A) of the Social Security Act, the Department of Medical Assistance Services ("DMAS") establishes payment rates for services that are reasonable and adequate to meet the costs that must be incurred by efficiently and economically operated facilities to provide services in conformity with state and federal laws, regulations, and quality and safety standards. To establish these rates Virginia uses the Medicare principles of cost reimbursement in determining the allowable costs for Virginia's prospective payment system. Allowable costs will be determined from the filing of a uniform cost report by participating providers. The cost reports are due not later than 90 days after the provider's fiscal year end. If a complete cost report is not received within 90 days after the end of the provider's fiscal year, the Program shall take action in accordance with its policies to assure that an overpayment is not being made. The cost report will be judged complete when DMAS has all of the following:

1. Completed cost reporting form(s) provided by DMAS, with signed certification(s);

2. The provider's trial balance showing adjusting journal entries;

3. The provider's financial statements including, but not limited to, a balance sheet, a statement of income and expenses, a statement of retained earnings (or fund balance), a statement of charges in financial position, and footnotes to the financial statements;

4. Schedules which reconcile financial statements and trial balance to expenses claimed in the cost report;

5. Home office cost report, if applicable; and

6. Such other analytical information or supporting documents requested by DMAS when the cost reporting forms are sent to the provider.

Although utilizing the cost apportionment and cost finding methods of the Medicare Program, Virginia does not adopt the prospective payment system of the Medicare Program enacted October 1, 1983.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR Part 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-4.1910, §VI, Volume 4, Issue 22, eff. September 1, 1988.

12VAC30-70-70 Revaluation of assets

A. Effective July 1, 2008, the valuation of an asset of a hospital or long-term care facility which has undergone a change of ownership on or after July 18, 1984, shall be the lesser of the seller's allowable depreciated historical cost (net book value) as determined for Medicaid reimbursement of the owner of record as of July 18, 1984, or the acquisition cost to the new owner.

B. In the case of an asset not in existence as of July 18, 1984, the valuation of an asset of a hospital or long-term care facility shall be the lesser of the seller's allowable depreciated historical cost (net book value) as determined for Medicaid reimbursement of the first owner of record, or the acquisition cost to the new owner.

C. In establishing appropriate allowance for depreciation, interest on capital indebtedness, and return on equity (if applicable prior to July 1, 1986) the base to be used for such computations shall be limited to subsection A or B of this section.

D. Costs (including legal fees, accounting and administrative costs, travel costs, and feasibility studies) attributable to the negotiation or settlement of the sale or purchase of any capital asset (by acquisition or merger) shall be reimbursable only to the extent that they have not been previously reimbursed by Medicaid.

E. Rental charges in sale and leaseback agreements shall be restricted to the depreciation, mortgage interest and (if applicable prior to July 1, 1986) return on equity based on cost of ownership as determined in accordance with subsections A and B of this section.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-02-4.1910, §VII, eff. September 1, 1988; amended, Virginia Register Volume 25, Issue 3, eff. November 27, 2008.

12VAC30-70-80 Refund of overpayments

A. Lump sum payment. When the provider files a cost report indicating that an overpayment has occurred, full refund shall be remitted with the cost report. In cases where DMAS discovers an overpayment during desk review, field audit, or final settlement, DMAS shall promptly send the first demand letter requesting a lump sum refund. Recovery shall be undertaken even though the provider disputes in whole or in part DMAS's determination of the overpayment.

B. Offset. If the provider has been overpaid for a particular fiscal year and has been underpaid for another fiscal year, the underpayment shall be offset against the overpayment. So long as the provider has an overpayment balance, any underpayments discovered by subsequent review or audit shall also be used to reduce the remaining amount of the overpayment.

C. Payment schedule. If the provider cannot refund the total amount of the overpayment (i) at the time it files a cost report indicating that an overpayment has occurred, the provider shall request an extended repayment schedule at the time of filing, or (ii) within 30 days after receiving the DMAS demand letter, the provider shall promptly request an extended repayment schedule.

DMAS may establish a repayment schedule of up to 12 months to recover all or part of an overpayment or, if a provider demonstrates that repayment within a 12-month period would create severe financial hardship, the Director of the Department of Medical Assistance Services (the "director") may approve a repayment schedule of up to 36 months.

A provider shall have no more than one extended repayment schedule in place at one time. If an audit later uncovers an additional overpayment, the full amount shall be repaid within 30 days unless the provider submits further documentation supporting a modification to the existing extended repayment schedule to include the additional amount.

If, during the time an extended repayment schedule is in effect, the provider withdraws from the Program or fails to file a cost report in a timely manner, the outstanding balance shall become immediately due and payable. When a repayment schedule is used to recover only part of an overpayment, the remaining amount shall be recovered by the reduction of interim payments to the provider or by lump sum payments.

D. Extension request documentation. In the request for an extended repayment schedule, the provider shall document the need for an extended (beyond 30 days) repayment and submit a written proposal scheduling the dates and amounts of repayments. If DMAS approves the schedule, DMAS shall send the provider written notification of the approved repayment schedule, which shall be effective retroactive to the date the provider submitted the proposal.

E. Interest charge on extended repayment. Once an initial determination of overpayment has been made, DMAS shall undertake full recovery of such overpayment whether or not the provider disputes, in whole or in part, the initial determination of overpayment. If an appeal follows, interest shall be waived during the period of administrative appeal of an initial determination of overpayment.

Interest charges on the unpaid balance of any overpayment shall accrue pursuant to § 32.1-313 of the Code of Virginia from the date the director's determination becomes final.

The director's determination shall be deemed to be final on (i) the due date of any cost report filed by the provider indicating that an overpayment has occurred, or (ii) the issue date of any notice of overpayment, issued by DMAS, if the provider does not file an appeal, or (iii) the issue date of any administrative decision issued by DMAS after an informal fact finding conference, if the provider does not file an appeal, or (iv) the issue date of any administrative decision signed by the director, regardless of whether a judicial appeal follows. In any event, interest shall be waived if the overpayment is completely liquidated within 30 days of the date of the final determination. In cases in which a determination of overpayment has been judicially reversed, the provider shall be reimbursed that portion of the payment to which it is entitled, plus any applicable interest which the provider paid to DMAS.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia and Item 322 J of Chapter 912 of the 1996 Virginia Acts of Assembly.
• Historical Notes: Derived from VR460-02-4.1910, §VIII, eff. September 1, 1988; amended, Virginia Register Volume 13, Issue 18, eff. July 1, 1997.

12VAC30-70-90 Reimbursement of certified hospitals exempt from Medicare Prospective Payment system

Effective October 1, 1986, hospitals that have obtained Medicare certification as inpatient rehabilitation hospitals or rehabilitation units in acute care hospitals, which are exempted from the Medicare Prospective Payment System (DRG), shall be reimbursed in accordance with the current Medicaid Prospective Payment System as described in the 12VAC30-70-10 through 12VAC30-70-80, excluding 12VAC30-70-50 (6). Additionally, rehabilitation hospitals and rehabilitation units of acute care hospitals which are exempt from the Medicare Prospective Payment System will be required to maintain separate cost accounting records, and to file separate cost reports annually utilizing the applicable Medicare cost reporting forms (HCFA 2552 series) and the Medicaid forms (MAP-783 series).

A new facility shall have an interim rate determined using a pro forma cost report or detailed budget prepared by the provider and accepted by the DMAS, which represents its anticipated allowable cost for the first cost reporting period of participation. For the first cost reporting period, the provider will be held to the lesser of its actual operating cost or its peer group ceiling. Subsequent rates will be determined in accordance with the current Medicaid Prospective Payment System as noted in the preceding paragraph.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR Part 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-4.1910, §IX, eff. September 1, 1988.

12VAC30-70-100 Reimbursement of return on equity capital to proprietary providers

Item 398D of the 1987 Appropriation Act (as amended), effective April 8, 1987, eliminated reimbursement of return on equity capital to proprietary providers.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR Part 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-4.1910, §X, Volume 4, Issue 22, eff. September 1, 1988.

12VAC30-70-110 Group ceiling for state-owned university teaching hospitals

A. Pursuant to Item 389 E4 of the 1988 Appropriation Act (as amended), effective July 1, 1988, a separate group ceiling for allowable operating cost shall be established for state-owned university teaching hospitals.

B. Effective July 1, 1994, the separate group ceiling for allowable operating costs for state-owned university teaching hospitals shall be calculated using cost report and other applicable data pertaining to facility fiscal year ending June 30, 1993.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR Part 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-4.1910, §XI, eff. July 1, 1994.

12VAC30-70-120 (Repealed.)

Historical Notes

Derived from VR460-02-4.1910, §XII, eff. May 1, 1994; amended, Virginia Register Volume 14, Issue 1, eff. December 1, 1997; repealed, Virginia Register Volume 18, Issue 6, eff. January 2, 2002.

12VAC30-70-130 Payment adjustment fund

A. A Payment Adjustment Fund shall be created in each of the Commonwealth's fiscal years during the period July 1, 1992, to June 30, 1996. The Payment Adjustment Fund shall consist of the Commonwealth's cumulative addition of five million dollars in General funds and its corresponding federal financial participation for reimbursement to non-state owned hospitals in each of the Commonwealth's fiscal years during this period. Each July 1, or as soon thereafter as is reasonably possible, the Commonwealth shall, through a single payment to each non-state owned hospital, equitably and fully disburse the Payment Adjustment Fund for that year.

B. In the absence of any amendment to this section, for the Commonwealth's fiscal year after 1996, the Payment Adjustment Fund shall be continued at the level established in 1996 and shall be disbursed in accordance with the methodology described below.

C. The Payment Adjustment Fund shall be disbursed in accordance with the following methodology:

1. Identify each non-state owned hospital provider (acute, neonatal and rehabilitation) receiving payment based upon its peer group operating ceiling in May of each year.

2. For each such hospital identified in Paragraph 1, identify its Medicaid paid days for the 12 months ending each May 31.

3. Multiply each such hospital's days under Paragraph 2 by such hospital's May individual peer group ceiling (i.e., disregarding such hospital's actual fiscal year end ceiling) as adjusted by its then current disproportionate share factor.

4. Sum all hospital amounts determined in Paragraph 3.

5. For each such hospital, divide its amount determined in Paragraph 3 by the total of such amounts determined in Paragraph 4. This then becomes the hospital adjustment factor ("HAF") for each such hospital.

6. Multiply each such hospital's HAF times the amount of the Payment Adjustment Fund ("PAF") to determine its potential PAF share.

7. Determine the unreimbursed Medicaid allowable operating cost per day for each such hospital in Paragraph 1 for the most recent fiscal year on file at DMAS as of May 31, inflate such costs by DRI-V+2 from the mid-point of such cost report to May 31 and multiply such inflated costs per day by the days identified for that hospital in Paragraph 2 above, creating the "unreimbursed amount."

8. Compare each such hospital's potential PAF share to its unreimbursed amount.

9. Allocate to all hospitals, where the potential PAF share exceeds the unreimbursed amount, such hospital's unreimbursed amount as its actual PAF share.

10. If the PAF is not exhausted, for those hospitals with an unreimbursed amount balance, recalculate a new HAF for each such hospital by dividing the hospital's HAF by the total of the HAFs for all hospitals with an unreimbursed amount balance.

11. Recompute each hospital's new potential share of the undisbursed PAF by multiplying such finds by each hospital's new HAF.

12. Compare each hospital's new potential PAF share to its unreimbursed amount. If the unreimbursed amounts exceed the PAF shares at all hospitals, each hospital's new PAF share becomes its actual PAF share. If some hospitals' unreimbursed amounts are less than the new potential PAF shares, allocate to such hospitals their unreimbursed amount as their actual PAF share. Then, for those hospitals with an unreimbursed amount balance, repeat steps 10, 11, and 12 until each hospital's actual PAF share is determined and the PAF is exhausted.

13. The annual payment to be made to each non-state owned hospital from the PAF shall be equal to their actual PAF share as determined and allocated above. Each hospital's actual PAF share payment shall be made on July 1, or as soon thereafter as is reasonable feasible.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR Part 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-02-4.1910, §XIII, eff. July 1, 1992.

Part II Hospital Appeals of Reimbursement Rates [Repealed]

12VAC30-70-140 (Repealed.)

Historical Notes

Derived from VR460-03-4.1911, eff. July 1, 1989, and Virginia Register Volume 13, Issue 18, eff. July 1, 1997; amended, Virginia Register Volume 13, Issue 18, eff. July 1, 1997; Volume 14, Issue 1, eff. December 1, 1997; repealed, Virginia Register Volume 17, Issue 19, eff. July 4, 2001.

Part III Dispute Resolution for State-Operated Facilities

12VAC30-70-150 Methods and standards for establishing payment rates - inpatient hospital care: Dispute resolution for state-operated providers

§ 1. Definitions.

"DMAS" means the Department of Medical Assistance Services.

"Division Director" means the Director of a division of DMAS.

"State-operated provider" means a provider of Medicaid services which is enrolled in the Medicaid program and operated by the Commonwealth of Virginia.

§ 2. Right to request reconsideration.

A. A state-operated provider shall have the right to request a reconsideration for any issue which would be otherwise administratively appealable under the State Plan by a non-state operated provider. This shall be the sole procedure available to state-operated providers.

B. The appropriate DMAS Division must receive the reconsideration request within 30 calendar days after the provider receives its Notice of Amount of Program Reimbursement, notice of proposed action, findings letter, or other DMAS notice giving rise to a dispute.

§ 3. Informal review. The state-operated provider shall submit to the appropriate DMAS Division written information specifying the nature of the dispute and the relief sought. If a reimbursement adjustment is sought, the written information must include the nature of the adjustment sought; the amount of the adjustment sought; and the reasons for seeking the adjustment. The Division Director or his designee shall review this information, requesting additional information as necessary. If either party so requests, they may meet to discuss a resolution. Any designee shall then recommend to the Division Director whether relief is appropriate in accordance with applicable law and regulations.

§ 4. Division Director action. The Division Director shall consider any recommendation of his designee and shall render a decision.

§ 5. DMAS Director review. A state-operated provider may, within 30 days after receiving the informal review decision of the Division Director, request that the DMAS Director or his designee review the decision of the Division Director. The DMAS Director shall have the authority to take whatever measures he deems appropriate to resolve the dispute.

§ 6. Secretarial review. If the preceding steps do not resolve the dispute to the satisfaction of the state-operated provider, within 30 days after receipt of the decision of the DMAS Director, the provider may request the DMAS Director to refer the matter to the Secretary of Health and Human Resources and any other Cabinet Secretary as appropriate. Any determination by such Secretary or Secretaries shall be final.

History

• Statutory Authority: Social Security Act Title XIX; 42 CFR Part 430 to end; all other applicable statutory and regulatory sections.
• Historical Notes: Derived from VR460-03-4.1912, eff. July 1, 1997.

Part IV [Reserved]

12VAC30-70-160 [Reserved]. (Reserved)

12VAC30-70-200 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 13, Issue 18, eff. July 1, 1997; repealed, Virginia Register Volume 16, Issue 18, eff. July 1, 2000.

Article 1 Application of Payment Methodologies

12VAC30-70-201 Application of payment methodologies

Article 1 Application of Payment Methodologies

A. The state agency will pay for inpatient hospital services, as set out in 12VAC30-50-100, in general acute care hospitals, rehabilitation hospitals, and freestanding psychiatric facilities licensed as hospitals under a prospective payment methodology. This methodology uses both per case and per diem payment methods. Article 2 (12VAC30-70-221 et seq.) of this part describes the prospective payment methodology, including both the per case and the per diem methods.

B. Article 3 (12VAC30-70-400 et seq.) of this part describes a per diem methodology that applied to a portion of payment to general acute care hospitals during state fiscal years 1997 and 1998, and that will continue to apply to patient stays with admission dates prior to July 1, 1996. Inpatient hospital services that are provided in long stay hospitals shall be subject to the provisions of Supplement 3 (12VAC30-70-10 through 12VAC30-70-130).

C. Inpatient hospital facilities operated by the Department of Behavioral Health and Developmental Services (DBHDS) shall be reimbursed costs except for inpatient psychiatric services furnished under early and periodic screening, diagnosis, and treatment (EPSDT) services for individuals younger than age 21. These inpatient services shall be reimbursed according to 12VAC30-70-415 and shall be provided according to the requirements set forth in 12VAC30-50-130 and 12VAC30-60-25 H. Facilities may also receive disproportionate share hospital (DSH) payments. The criteria for DSH eligibility and the payment amount shall be based on subsection F of 12VAC30-70-50. If the DSH limit is exceeded by any facility, the excess DSH payments shall be distributed to all other qualifying DBHDS facilities in proportion to the amount of DSH they otherwise receive.

D. Transplant services shall not be subject to the provisions of this part. Reimbursement for covered liver, heart, and bone marrow/stem cell transplant services and any other medically necessary transplantation procedures that are determined to not be experimental or investigational shall be a fee based upon the greater of a prospectively determined, procedure-specific flat fee determined by the agency or a prospectively determined, procedure-specific percentage of usual and customary charges. The flat fee reimbursement will cover procurement costs; all hospital costs from admission to discharge for the transplant procedure; and total physician costs for all physicians providing services during the hospital stay, including radiologists, pathologists, oncologists, surgeons, etc. The flat fee reimbursement does not include pre-hospitalization and post-hospitalization for the transplant procedure or pretransplant evaluation. If the actual charges are lower than the fee, the agency shall reimburse the actual charges. Reimbursement for approved transplant procedures that are performed out of state will be made in the same manner as reimbursement for transplant procedures performed in the Commonwealth. Reimbursement for covered kidney and cornea transplants is at the allowed Medicaid rate. Standards for coverage of organ transplant services are in 12VAC30-50-540 through 12VAC30-50-580.

E. Reduction of payments methodology.

1. For state fiscal years 2003 and 2004, the Department of Medical Assistance Services (DMAS) shall reduce payments to hospitals participating in the Virginia Medicaid Program by $8,935,825 total funds, and $9,227,815 total funds respectively. For purposes of distribution, each hospital's share of the total reduction amount shall be determined as provided in this subsection.

2. Determine base for revenue forecast.

a. DMAS shall use, as a base for determining the payment reduction distribution for hospitals Type I and Type II, net Medicaid inpatient operating reimbursement and outpatient reimbursed cost, as recorded by DMAS for state fiscal year 1999 from each individual hospital settled cost reports. This figure is further reduced by 18.73%, which represents the estimated statewide HMO average percentage of Medicaid business for those hospitals engaged in HMO contracts, to arrive at net baseline proportion of non-HMO hospital Medicaid business.

b. For freestanding psychiatric hospitals, DMAS shall use estimated Medicaid revenues for the six-month period (January 1, 2001, through June 30, 2001), times two, and adjusted for inflation by 4.3% for state fiscal year 2002, 3.1% for state fiscal year 2003, and 3.7% for state fiscal year 2004, as reported by DRI-WEFA, Inc.'s, hospital input price level percentage moving average.

3. Determine forecast revenue.

a. Each Type I hospital's individual state fiscal year 2003 and 2004 forecast reimbursement is based on the proportion of non-HMO business (see subdivision 2 a of this subsection) with respect to the DMAS forecast of SFY 2003 and 2004 inpatient and outpatient operating revenue for Type I hospitals.

b. Each Type II, including freestanding psychiatric, hospital's individual state fiscal year 2003 and 2004 forecast reimbursement is based on the proportion of non-HMO business (see subdivision 2 of this subsection) with respect to the DMAS forecast of SFY 2003 and 2004 inpatient and outpatient operating revenue for Type II hospitals.

4. Each hospital's total yearly reduction amount is equal to its respective state fiscal year 2003 and 2004 forecast reimbursement as described in subdivision 3 of this subsection, times 3.235857% for state fiscal year 2003, and 3.235857%, for the first two quarters of state fiscal year 2004 and 2.88572% for the last two quarters of state fiscal year 2004, not to be reduced by more than $500,000 per year.

5. Reductions shall occur quarterly in four amounts as offsets to remittances. Each hospital's payment reduction shall not exceed that calculated in subdivision 4 of this subsection. Payment reduction offsets not covered by claims remittance by May 15, 2003, and 2004, will be billed by invoice to each provider with the remaining balances payable by check to the Department of Medical Assistance Services before June 30, 2003, or 2004, as applicable.

F. Consistent with 42 CFR 447.26 and effective July 1, 2012, the Commonwealth shall not reimburse inpatient hospitals for provider-preventable conditions (PPCs), which include:

1. Health care-acquired conditions (HCACs). HCACs are conditions occurring in any hospital setting, identified as a hospital-acquired condition (HAC) by Medicare other than deep vein thrombosis (DVT)/pulmonary embolism (PE) following total knee replacement or hip replacement surgery in pediatric and obstetric patients.

2. Other provider preventable conditions (OPPCs) as follows: (i) wrong surgical or other invasive procedure performed on a patient; (ii) surgical or other invasive procedure performed on the wrong body part; or (iii) surgical or other invasive procedure performed on the wrong patient.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 18, eff. July 1, 2000; amended, Virginia Register Volume 18, Issue 7, eff. January 16, 2002; Volume 19, Issue 21, eff. August 1, 2003; Volume 20, Issue 5, eff. January 4, 2004; Volume 27, Issue 15, eff. April 27, 2011; Volume 28, Issue 15, eff. April 25, 2012; Volume 33, Issue 12, eff. March 8, 2017; Volume 33, Issue 12, eff. April 1, 2017.

12VAC30-70-210 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 13, Issue 18, eff. July 1, 1997; repealed, Virginia Register Volume 16, Issue 18, eff. July 1, 2000.

12VAC30-70-220 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 13, Issue 18, eff. July 1, 1997; repealed, Virginia Register Volume 16, Issue 18, eff. July 1, 2000.

Article 2 Prospective (DRG-Based) Payment Methodology

12VAC30-70-221 General

Article 2 Prospective (DRG-Based) Payment Methodology

A. Effective July 1, 2000, the prospective (DRG-based) payment system described in this article shall apply to inpatient hospital services provided in enrolled general acute care hospitals, rehabilitation hospitals, and freestanding psychiatric facilities licensed as hospitals, unless otherwise noted.

B. The following methodologies shall apply under the prospective payment system:

1. As stipulated in 12VAC30-70-231, operating payments for DRG cases that are not transfer cases shall be determined on the basis of a hospital specific operating rate per case times relative weight of the DRG to which the case is assigned.

2. As stipulated in 12VAC30-70-241, operating payments for per diem cases shall be determined on the basis of a hospital specific operating rate per day times the covered days for the case with the exception of payments for per diem cases in freestanding psychiatric facilities. Payments for per diem cases in freestanding psychiatric facilities licensed as hospitals shall be determined on the basis of a hospital specific rate per day that represents an all-inclusive payment for operating and capital costs.

3. As stipulated in 12VAC30-70-251, operating payments for transfer cases shall be determined as follows: (i) the transferring hospital shall receive an operating per diem payment, not to exceed the DRG operating payment that would have otherwise been made and (ii) the final discharging hospital shall receive the full DRG operating payment.

4. As stipulated in 12VAC30-70-261, additional operating payments shall be made for outlier cases. These additional payments shall be added to the operating payments determined in subdivisions 1 and 3 of this subsection.

5. As stipulated in 12VAC30-70-271, payments for capital costs shall be made on an allowable cost basis.

6. As stipulated in 12VAC30-70-281, payments for direct medical education costs of nursing schools and paramedical programs shall be made on an allowable cost basis. For Type Two hospitals, payment for direct graduate medical education (GME) costs for interns and residents shall be made quarterly on a prospective basis, subject to cost settlement based on the number of full-time equivalent (FTE) interns and residents as reported on the cost report. Effective April 1, 2012, payment for direct GME for interns and residents for Type One hospitals shall be 100% of allowable costs.

7. As stipulated in 12VAC30-70-291, payments for indirect medical education costs shall be made quarterly on a prospective basis.

8. As stipulated in 12VAC30-70-301, payments to hospitals that qualify as disproportionate share hospitals shall be made quarterly on a prospective basis.

C. The terms used in this article shall be defined as provided in this subsection:

"AP-DRG" means all patient diagnosis related groups.

"APR-DRG" means all patient refined diagnosis related groups.

"Base year" means the state fiscal year for which data is used to establish the DRG relative weights, the hospital case-mix indices, the base year standardized operating costs per case, and the base year standardized operating costs per day. The base year will change when the DRG payment system is rebased and recalibrated. In subsequent rebasings, the Commonwealth shall notify affected providers of the base year to be used in this calculation.

"Base year standardized costs per case" means the statewide average hospital costs per discharge for DRG cases in the base year. The standardization process removes the effects of case-mix and regional variations in wages from the claims data and places all hospitals on a comparable basis.

"Base year standardized costs per day" means the statewide average hospital costs per day for per diem cases in the base year. The standardization process removes the effects of regional variations in wages from the claims data and places all hospitals on a comparable basis. Base year standardized costs per day were calculated separately, but using the same calculation methodology, for the different types of per diem cases identified in this subsection under the definition of "per diem cases."

"Cost" means allowable cost as defined in Supplement 3 (12VAC30-70-10 through 12VAC30-70-130) and by Medicare principles of reimbursement.

"Disproportionate share hospital" means a hospital that meets the following criteria:

1. A Medicaid inpatient utilization rate in excess of 14%, or a low-income patient utilization rate exceeding 25% (as defined in the Omnibus Budget Reconciliation Act of 1987 and as amended by the Medicare Catastrophic Coverage Act of 1988); and

2. At least two obstetricians with staff privileges at the hospital who have agreed to provide obstetric services to individuals entitled to such services under a state Medicaid plan. In the case of a hospital located in a rural area (that is, an area outside of a Metropolitan Statistical Area as defined by the Executive Office of Management and Budget), the term "obstetrician" includes any physician with staff privileges at the hospital to perform nonemergency obstetric procedures.

3. Subdivision 2 of this definition does not apply to a hospital:

a. At which the inpatients are predominantly individuals under 18 years of age; or

b. Which does not offer nonemergency obstetric services as of December 21, 1987.

"DRG" means diagnosis related groups.

"DRG cases" means medical or surgical cases subject to payment on the basis of DRGs. DRG cases do not include per diem cases.

"DRG relative weight" means the average standardized costs for cases assigned to that DRG divided by the average standardized costs for cases assigned to all DRGs.

"Groupable cases" means DRG cases having coding data of sufficient quality to support DRG assignment.

"Hospital case-mix index" means the weighted average DRG relative weight for all cases occurring at that hospital.

"Medicaid utilization percentage" or "Medicaid inpatient utilization rate" is equal to the hospital's total Medicaid inpatient days divided by the hospital's total inpatient days for a given hospital fiscal year. The Medicaid utilization percentage or Medicaid inpatient utilization rate includes days associated with inpatient hospital services provided to Medicaid patients but reimbursed by capitated managed care providers. This definition includes all paid Medicaid days and nonpaid or denied Medicaid days to include medically unnecessary days, inappropriate level of care service days, and days that exceed any maximum day limits (with appropriate documentation). The definition of Medicaid days does not include any general assistance, Family Access to Medical Insurance Security (FAMIS), State and Local Hospitalization (SLH), charity care, low-income care, indigent care, uncompensated care, bad debt, or Medicare dually eligible days. It does not include days for newborns not enrolled in Medicaid during the fiscal year even though the mother was Medicaid eligible during the birth. Effective July 1, 2014, the definition for Medicaid utilization percentage or Medicaid inpatient utilization rate is defined in 12VAC30-70-301 C.

"Medicare wage index" and the "Medicare geographic adjustment factor" are published annually in the Federal Register by the Health Care Financing Administration. The indices and factors used in this article shall be those in effect in the base year.

"Operating cost-to-charge ratio" equals the hospital's total operating costs, less any applicable operating costs for a psychiatric distinct part unit (DPU), divided by the hospital's total charges, less any applicable charges for a psychiatric DPU. The costs shall be calculated by multiplying the per diems and ancillary cost-to-charge ratios from each hospital's cost ending in the state fiscal year used as the base year to the corresponding days and ancillary charges by revenue code for each hospital's groupable cases.

"Outlier adjustment factor" means a fixed factor published annually in the Federal Register by the Health Care Financing Administration. The factor used in this article shall be the one in effect in the base year.

"Outlier cases" means those DRG cases, including transfer cases, in which the hospital's adjusted operating cost for the case exceeds the hospital's operating outlier threshold for the case.

"Outlier operating fixed loss threshold" means a fixed dollar amount applicable to all hospitals that shall be calculated in the base year so as to result in an expenditure for outliers operating payments equal to 5.1% of total operating payments for DRG cases. The threshold shall be updated in subsequent years using the same inflation values applied to hospital rates.

"Per diem cases" means cases subject to per diem payment and includes (i) covered psychiatric cases in general acute care hospitals and distinct part units (DPUs) of general acute care hospitals (hereinafter "acute care psychiatric cases"), (ii) covered psychiatric cases in freestanding psychiatric facilities licensed as hospitals (hereinafter "freestanding psychiatric cases"), and (iii) rehabilitation cases in general acute care hospitals and rehabilitation hospitals (hereinafter "rehabilitation cases").

"Psychiatric cases" means cases with a principal diagnosis that is a mental disorder as specified in the ICD, as defined in 12VAC30-95-5. Not all mental disorders are covered. For coverage information, see Amount, Duration, and Scope of Services, Supplement 1 to Attachment 3.1 A & B (12VAC30-50-95 through 12VAC30-50-310). The limit of coverage of 21 days in a 60-day period for the same or similar diagnosis shall continue to apply to adult psychiatric cases.

"Psychiatric operating cost-to-charge ratio" for the psychiatric DPU of a general acute care hospital means the hospital's operating costs for a psychiatric DPU divided by the hospital's charges for a psychiatric DPU. In the base year, this ratio shall be calculated as described in the definition of "operating cost-to-charge ratio" in this subsection, using data from psychiatric DPUs.

"Readmissions" means when patients are readmitted to the same hospital for the same or a similar diagnosis. Similar diagnoses shall be defined as ICD diagnosis codes possessing the same first three digits. As used here, the term "ICD" is defined in 12VAC30-95-5.

"Rehabilitation operating cost-to-charge ratio" for a rehabilitation unit or hospital means the provider's operating costs divided by the provider's charges. In the base year, this ratio shall be calculated as described in the definition of "operating cost-to-charge ratio" in this subsection, using data from rehabilitation units or hospitals.

"Statewide average labor portion of operating costs" means a fixed percentage applicable to all hospitals. The percentage shall be periodically revised using the most recent reliable data from the Virginia Health Information (VHI), or its successor.

"Transfer cases" means DRG cases involving patients (i) who are transferred from one general acute care hospital to another for related care or (ii) who are discharged from one general acute care hospital and admitted to another for the same or a similar diagnosis within five days of that discharge. Similar diagnoses shall be defined as ICD diagnosis codes possessing the same first three digits. As used here, the term "ICD" is defined in 12VAC30-95-5.

"Type One hospitals" means those hospitals that were state-owned teaching hospitals on January 1, 1996.

"Type Two hospitals" means all other hospitals.

"Uncompensated care costs" or "UCC" means unreimbursed costs incurred by hospitals from serving self-pay, charity, or Medicaid patients without regard to disproportionate share adjustment payments.

"Ungroupable cases" means cases assigned to DRG 469 (principal diagnosis invalid as discharge diagnosis) and DRG 470 (ungroupable) as determined by the AP-DRG Grouper. Effective October 1, 2014, "ungroupable cases" means cases assigned to DRG 955 (ungroupable) and DRG 956 (ungroupable) as determined by the APR-DRG grouper.

D. The all patient diagnosis related groups (AP-DRG) grouper shall be used in the DRG payment system. Effective October 1, 2014, DMAS shall replace the AP-DRG grouper with the all patient refined diagnosis related groups (APR-DRG) grouper for hospital inpatient reimbursement. The APR-DRG grouper will produce a DRG as well as a severity level ranging from 1 to 4. DMAS shall phase in the APR-DRG weights by blending in 50% of the full APR-DRG weights with 50% of fiscal year (FY) 2014 AP-DRG weights for each APR-DRG group and severity level in the first year. In the second year, the blend will be 75% of full APR-DRG weights and 25% of the FY 2014 AP-DRG weights. Full APR-DRG weights shall be used in the third year and succeeding years for each APR-DRG group and severity. DMAS shall notify hospitals when updating the system to later grouper versions.

E. The primary data sources used in the development of the DRG payment methodology were the department's hospital computerized claims history file and the cost report file. The claims history file captures available claims data from all enrolled, cost-reporting general acute care hospitals, including Type One hospitals. The cost report file captures audited cost and charge data from all enrolled general acute care hospitals, including Type One hospitals. The following table identifies key data elements that were used to develop the DRG payment methodology and that will be used when the system is recalibrated and rebased.

| Data Elements for DRG Payment Methodology | | | --- | --- | | Data Elements | Source | | Total charges for each groupable case | Claims history file | | Number of groupable cases in each DRG | Claims history file | | Total number of groupable cases | Claims history file | | Total charges for each DRG case | Claims history file | | Total number of DRG cases | Claims history file | | Total charges for each acute care psychiatric case | Claims history file | | Total number of acute care psychiatric days for each acute care hospital | Claims history file | | Total charges for each freestanding psychiatric case | Medicare cost reports | | Total number of psychiatric days for each freestanding psychiatric hospital | Medicare cost reports | | Total charges for each rehabilitation case | Claims history file | | Total number of rehabilitation days for each acute care and freestanding rehabilitation hospital | Claims history file | | Operating cost-to-charge ratio for each hospital | Cost report file | | Operating cost-to-charge ratio for each freestanding psychiatric facility licensed as a hospital | Medicare cost reports | | Psychiatric operating cost-to-charge ratio for the psychiatric DPU of each general acute care hospital | Cost report file | | Rehabilitation cost-to-charge ratio for each rehabilitation unit or hospital | Cost report file | | Statewide average labor portion of operating costs | VHI | | Medicare wage index for each hospital | Federal Register | | Medicare geographic adjustment factor for each hospital | Federal Register | | Outlier operating fixed loss threshold | Claims history file | | Outlier adjustment factor | Federal Register |

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 18, eff. July 1, 2000; amended, Virginia Register Volume 19, Issue 18, eff. July 1, 2003; Volume 24, Issue 21, eff. July 23, 2008; Volume 26, Issue 12, eff. March 17, 2010; Volume 26, Issue 19, eff. July 1, 2010; Volume 28, Issue 15, eff. April 25, 2012; Volume 30, Issue 18, eff. June 5, 2014; Volume 31, Issue 9, eff. February 13, 2015; Volume 33, Issue 19, eff. June 29, 2017; Volume 34, Issue 11, eff. February 21, 2018; Volume 37, Issue 9, eff. January 20, 2021.

12VAC30-70-230 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 13, Issue 18, eff. July 1, 1997; repealed, Virginia Register Volume 16, Issue 18, eff. July 1, 2000.

12VAC30-70-231 Operating payment for DRG cases

A. The operating payment for DRG cases that are not transfer cases shall be equal to the hospital specific operating rate per case, as determined in 12VAC30-70-311, times the DRG relative weight, as determined in 12VAC30-70-381.

B. Exceptions.

1. Special provisions for calculating the operating payment for transfer cases are provided in 12VAC30-70-251.

2. Readmissions within five days of discharge shall be considered a continuation of the same stay and shall not be treated as a new case.

3. Effective July 1, 2020, readmissions within six to 30 days of discharge shall be paid at 50% of the normal rate unless it is a planned readmission, an obstetrical readmission, an admission to critical access hospitals, or in any case where the patient was originally discharged against medical advice.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 18, eff. July 1, 2000; amended, Virginia Register Volume 37, Issue 9, eff. January 20, 2021.

12VAC30-70-240 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 13, Issue 18, eff. July 1, 1997; repealed, Virginia Register Volume 16, Issue 18, eff. July 1, 2000.

12VAC30-70-241 Operating payment for per diem cases

A. The operating payment for acute care psychiatric cases and rehabilitation cases shall be equal to the hospital specific operating rate per day, as determined in subsection A of 12VAC30-70-321, times the covered days for the case.

B. The payment for freestanding psychiatric cases shall be equal to the hospital specific rate per day for freestanding psychiatric cases, as determined in subsection B of 12VAC30-70-321, times the covered days for the case.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 18, eff. July 1, 2000.

12VAC30-70-250 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 13, Issue 18, eff. July 1, 1997; repealed, Virginia Register Volume 16, Issue 18, eff. July 1, 2000.

12VAC30-70-251 Operating payment for transfer cases

A. The operating payment for transfer cases shall be determined as follows:

1. A transferring hospital shall receive the lesser of (i) a per diem payment equal to the hospital's DRG operating payment for the case, as determined in 12VAC30-70-231, divided by the arithmetic mean length of stay for the DRG into which the case falls times the length of stay for the case at the transferring hospital or (ii) the hospital's full DRG operating payment for the case, as determined in 12VAC30-70-231. The transferring hospital shall be eligible for an outlier operating payment, as specified in 12VAC30-70-261, if applicable criteria are satisfied.

2. The final discharging hospital shall receive the hospital's full DRG operating payment, as determined in 12VAC30-70-231. The final discharging hospital shall be eligible for an outlier operating payment, as specified in 12VAC30-70-261, if applicable criteria are satisfied.

B. Exceptions.

1. Cases falling into DRG 456, 639, or 640 shall not be treated as transfer cases. Effective October 1, 2014, cases falling into DRG 580 and 581 shall not be treated as transfer cases. Both the transferring hospital and the final discharging hospital shall receive the full DRG operating payment.

2. Cases transferred to or from a psychiatric or rehabilitation DPU of a general acute care hospital, a freestanding psychiatric facility licensed as a hospital, or a rehabilitation hospital shall not be treated as transfer cases.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 18, eff. July 1, 2000; amended, Virginia Register Volume 32, Issue 10, eff. February 25, 2016.

12VAC30-70-260 (Repealed.)

Historical Notes

Repealed, Virginia Register Volume 16, Issue 18, eff. July 1, 2000.

12VAC30-70-261 Outlier operating payment

A. An outlier operating payment shall be made for outlier cases. This payment shall be added to the operating payments determined in 12VAC30-70-231 and 12VAC30-70-251. Eligibility for the outlier operating payment and the amount of the outlier operating payment shall be determined as follows:

1. The hospital's adjusted operating cost for the case shall be estimated. This shall be equal to the hospital's total charges for the case times the hospital's operating cost-to-charge ratio, as defined in subsection C of 12VAC30-70-221, times the adjustment factor specified in 12VAC30-70-331 B.

2. The adjusted outlier operating fixed loss threshold shall be calculated as follows:

a. The outlier operating fixed loss threshold shall be multiplied by the statewide average labor portion of operating costs, yielding the labor portion of the outlier operating fixed loss threshold. Hence, the nonlabor portion of the outlier operating fixed loss threshold shall constitute one minus the statewide average labor portion of operating costs times the outlier operating fixed loss threshold.

b. The labor portion of the outlier operating fixed loss threshold shall be multiplied by the hospital's Medicare wage index, yielding the wage adjusted labor portion of the outlier operating fixed loss threshold.

c. The wage adjusted labor portion of the outlier operating fixed loss threshold shall be added to the nonlabor portion of the outlier operating fixed loss threshold, yielding the wage adjusted outlier operating fixed loss threshold.

3. The hospital's outlier operating threshold for the case shall be calculated. This shall be equal to the wage adjusted outlier operating fixed loss threshold times the adjustment factor specified in 12VAC30-70-331 B plus the hospital's operating payment for the case, as determined in 12VAC30-70-231 or 12VAC30-70-251.

4. The hospital's outlier operating payment for the case shall be calculated. This shall be equal to the hospital's adjusted operating cost for the case minus the hospital's outlier operating threshold for the case. If the difference is less than or equal to zero, then no outlier operating payment shall be made. If the difference is greater than zero, then the outlier operating payment shall be equal to the difference times the outlier adjustment factor.

B. The outlier operating fixed loss threshold shall be recalculated using base year data when the DRG payment system is recalibrated and rebased. The threshold shall be calculated so as to result in an expenditure for outlier operating payments equal to 5.1% of total operating payments, including outlier operating payments, for DRG cases. The methodology described in subsection A of this section shall be applied to all base year DRG cases on an aggregate basis, and the amount of the outlier operating fixed loss threshold shall be calculated so as to exhaust the available pool for outlier operating payments.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 18, eff. July 1, 2000; amended, Virginia Register Volume 25, Issue 3, eff. November 27, 2008.

12VAC30-70-270 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 13, Issue 18, eff. July 1, 1997; repealed, Virginia Register Volume 16, Issue 18, eff. July 1, 2000.

12VAC30-70-271 Payment for capital costs

A. Inpatient capital costs shall be determined on an allowable cost basis and settled at the hospital's fiscal year end. Allowable cost shall be determined following the methodology described in Supplement 3 (12VAC30-70-10 through 12VAC30-70-130).

B. For hospitals with fiscal years that are in progress and do not begin on July 1, inpatient capital costs for the fiscal year in progress shall be apportioned in accordance with subdivisions 1 through 6 of this subsection.

1. Inpatient capital costs apportioned before July 1, 2003, shall be settled at 100% of allowable cost.

2. Effective July 1, 2003, through June 30, 2009, inpatient capital costs of Type One hospitals shall be settled at 100% of allowable cost. Inpatient capital costs of Type Two hospitals shall be settled at 80% of allowable cost.

3. Effective July 1, 2009, through June 30, 2010, inpatient capital costs of Type One hospitals shall be settled at 100% of allowable cost. Inpatient capital costs of Type Two hospitals, excluding hospitals with Virginia Medicaid utilization greater than 50%, shall be settled at 75% of allowable cost. Inpatient capital costs of Type Two hospitals with Virginia Medicaid utilization greater than 50% shall be settled at 80% of allowable cost.

4. Effective July 1, 2010, through September 30, 2010, inpatient capital costs of Type One hospitals shall be settled at 97% of allowable costs. Inpatient capital costs of Type Two hospitals, excluding hospitals with Virginia Medicaid utilization greater than 50%, shall be settled at 72% of allowable cost. Inpatient capital costs of Type Two hospitals with Virginia Medicaid utilization greater than 50% shall be settled at 77% of allowable cost.

5. Effective October 1, 2010, through June 30, 2011, inpatient capital costs of Type One hospitals shall be settled at 100% of allowable cost. Inpatient capital costs of Type Two hospitals, excluding hospitals with Virginia Medicaid utilization greater than 50%, shall be settled at 75% of allowable cost. Inpatient capital costs of Type Two hospitals with Virginia Medicaid utilization greater than 50% shall be settled at 80% of allowable cost.

6. Effective July 1, 2011, inpatient capital costs of Type One hospitals shall be settled at 96% of allowable costs. Inpatient capital costs of Type Two hospitals, excluding hospitals with Virginia Medicaid utilization greater than 50%, shall be settled at 71% of allowable cost. Inpatient capital costs of Type Two hospitals with Virginia Medicaid utilization greater than 50% shall be settled at 76% of allowable cost.

7. Effective July 1, 2019, inpatient capital rates for critical access hospitals shall be 100% of cost reimbursement.

C. The exception to the policy in subsection A of this section is that the hospital specific rate per day for services in freestanding psychiatric facilities licensed as hospitals, as determined in 12VAC30-70-321 B, shall be an all-inclusive payment for operating and capital costs. The capital rate per day determined in 12VAC30-70-321 will be multiplied by the same percentage of allowable cost specified in subsection B of this section.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 18, eff. July 1, 2000; amended, Virginia Register Volume 20, Issue 19, eff. July 1, 2004; Volume 25, Issue 3, eff. November 27, 2008; Volume 26, Issue 12, eff. March 17, 2010; Volume 27, Issue 19, eff. July 1, 2011; Volume 36, Issue 8, eff. January 8, 2019.

12VAC30-70-280 (Repealed.)

Historical Notes

Repealed, Virginia Register Volume 16, Issue 18, eff. July 1, 2000.

12VAC30-70-281 Payment for direct medical education costs of nursing schools, paramedical programs, and graduate medical education for interns and residents

A. Direct medical education costs of nursing schools and paramedical programs shall continue to be paid on an allowable cost basis.

1. Payments for these direct medical education costs shall be made in estimated quarterly lump sum amounts and settled at the hospital's fiscal year end.

2. Final payment for these direct medical education (DMedEd) costs shall be the sum of the fee-for-service DMedEd payment and the managed care DMedEd payment. Fee-for-service DMedEd payment is the ratio of Medicaid inpatient costs to total allowable costs, times total DMedEd costs. Managed care DMedEd payment is equal to the managed care days times the ratio of fee-for-service DMedEd payments to fee-for-service days.

B. Effective with cost reporting periods beginning on or after July 1, 2002, direct graduate medical education (GME) costs for interns and residents shall be reimbursed on a per-resident prospective basis, subject to cost settlement as outlined in this subsection except that on or after April 1, 2012, payment for direct GME for interns and residents for Type One hospitals shall be 100% of allowable costs as outlined in subsection C of this section.

1. The methodology provides for the determination of a hospital-specific base period per-resident amount to initially be calculated from cost reports with fiscal years ending in state fiscal year 1998 or as may be rebased in the future and provided to the public in an agency guidance document. The per-resident amount for new qualifying facilities shall be calculated from the most recently settled cost report. This per-resident amount shall be calculated by dividing a hospital's Medicaid allowable direct GME costs for the base period by its number of interns and residents in the base period yielding the base amount.

2. The base amount shall be updated annually by the moving average values in the Virginia-Specific Hospital Input Price Index as described in 12VAC30-70-351. The updated per-resident base amount will then be multiplied by the weighted number of full-time equivalent (FTE) interns and residents as reported on the annual cost report to determine the total Medicaid direct GME amount allowable for each year. Payments for direct GME costs shall be made in estimated quarterly lump sum amounts and settled at the hospital's fiscal year end based on the actual number of FTEs reported in the cost reporting period. The total Medicaid direct GME allowable amount shall be allocated to inpatient and outpatient services based on Medicaid's share of costs under each part.

C. Effective April 1, 2012, Type One hospitals shall be reimbursed 100% of Medicaid allowable fee-for-service (FFS) and managed care organization (MCO) GME costs for interns and residents.

1. Type One hospitals shall submit annually separate FFS and MCO GME cost schedules, approved by the agency, using GME per diems and GME ratios of cost to charges (RCCs) from the Medicare and Medicaid cost reports and FFS and MCO days and charges. Type One hospitals shall provide information on managed care days and charges in a format similar to FFS.

2. Interim lump sum GME payments for interns and residents shall be made quarterly based on the total cost from the most recently audited cost report divided by four and will be final settled in the audited cost report for the fiscal year end in which the payments are made.

D. Direct medical education shall not be a reimbursable cost in freestanding psychiatric facilities licensed as hospitals.

E. The Department of Medical Assistance Services (DMAS) shall make supplemental payments to hospitals for qualified graduate medical residencies. Residency programs and hospital partners shall submit applications for this funding each year. Applications are available on the DMAS website at www.dmas.virginia.gov/#/gmefunding. The applications shall be scored, and the top applicants shall receive funding. The supplemental payment for each new qualifying residency slot will be $100,000 annually and will be made for up to four years. Payments shall be made quarterly. Additional criteria include:

1. Sponsoring institutions or the primary clinical site must be:

a. Physically located in Virginia;

b. An enrolled hospital provider in Virginia Medicaid and continue as a Medicaid-enrolled provider for the duration of the funding;

c. Not subject to a limit on Medicaid payments by the Centers for Medicare and Medicaid Services; and

d. Accredited through either the American Osteopathic Association or the Accreditation Council for Graduate Medical Education.

2. Applications must:

a. Be complete and submitted by the posted deadline;

b. Request funding for primary care, such as general pediatrics, general internal medicine, or family practice, or high-need specialty residencies; and

c. Provide substantiation of the need for the requested primary care or specialty residency.

3. Programs that are awarded funding in the fall must attest by June 1 that the residents have been hired for the start of the academic year and have continued employment with the program each year thereafter.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 18, eff. July 1, 2000; amended, Virginia Register Volume 19, Issue 18, eff. July 1, 2003; Volume 31, Issue 9, eff. February 13, 2015; Volume 34, Issue 11, eff. February 21, 2018; Volume 36, Issue 8, eff. January 8, 2020; Errata, 42:24 VA.R. 2223 July 13, 2026.

12VAC30-70-290 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 13, Issue 18, eff. July 1, 1997; repealed, Virginia Register Volume 16, Issue 18, eff. July 1, 2000.

12VAC30-70-291 Payment for indirect medical education costs

A. Hospitals shall be eligible to receive payments for indirect medical education (IME). Out-of-state cost reporting hospitals are eligible for this payment only if they have Virginia Medicaid utilization in the base year of at least 12% of total Medicaid days. These payments recognize the increased use of ancillary services associated with the educational process and the higher case-mix intensity of teaching hospitals. The payments for indirect medical education shall be made in estimated quarterly lump sum amounts and settled at the hospital's fiscal year end.

B. Final payment for IME shall be determined as follows:

1. Type One hospitals shall receive an IME payment equal to the hospital's Medicaid operating reimbursement times an IME percentage determined as follows (this formula also applies to Children's Hospital of the King's Daughters effective July 1, 2013):

IME Percentage for Type One Hospitals = [1.89 X ((1 + r)^0.405-1)] X (IME Factor)

An IME factor shall be calculated for each Type One hospital and shall equal a factor that, when used in the calculation of the IME percentage, shall cause the resulting IME payments to equal what the IME payments would be with an IME factor of one, plus an amount equal to the difference between operating payments using the adjustment factor specified in subdivision B 1 of 12VAC30-70-331 and operating payments using an adjustment factor of one in place of the adjustment factor specified in subdivision B 1 of 12VAC30-70-331.

2. Type Two hospitals shall receive an IME payment equal to the hospital's Medicaid operating reimbursement times an IME percentage determined as follows (excluding Children's Hospital of the King's Daughters):

IME Percentage for Type Two Hospitals = [1.89 X ((1 + r)^0.405-1)] X 0.5695

In both equations, r is the ratio of full-time equivalent residents to staffed beds, excluding nursery beds. The IME payment shall be calculated each year using the most recent reliable data regarding the number of full-time equivalent residents and the number of staffed beds, excluding nursery beds.

C. An additional IME payment shall be made for inpatient hospital services provided to Medicaid patients but reimbursed by capitated managed care providers.

1. For Type Two hospitals, this payment shall be equal to the hospital's hospital-specific operating rate per case, as determined in 12VAC30-70-311, times the hospital's HMO paid discharges times the hospital's IME percentage, as determined in subsection B of this section.

2. For Type One hospitals, this payment shall be equal to the hospital's hospital-specific operating rate per case, as determined in 12VAC30-70-311, times the hospital's HMO paid discharges times the hospital's IME percentage, as determined in subsection B of this section. Effective April 1, 2012, the operating rate per case used in the formula shall be revised to reflect an adjustment factor of one and case-mix adjusted by multiplying the operating rate per case in this subsection by the weight per case for FFS discharges that is determined during rebasing. This formula applies to Children's Hospital of the King's Daughters effective July 1, 2017.

D. An additional IME payment not to exceed $200,000 in total shall be apportioned among Type Two hospitals, excluding freestanding children's hospitals, with Medicaid NICU utilization in excess of 50% as reported to the Department of Medical Assistance Services as of March 1, 2004. These payments shall be apportioned based on each eligible hospital's percentage of Medicaid NICU patient days relative to the total of these days among eligible hospitals as reported by March 1, 2004.

E. An additional IME payment not to exceed $500,000 in total shall be apportioned among Type Two hospitals, excluding freestanding children's hospitals, with Medicaid NICU days in excess of 4,500 as reported to the Department of Medical Assistance Services as of March 1, 2005, that do not otherwise receive an additional IME payment under subsection D of this section. These payments shall be apportioned based on each eligible hospital's percentage of Medicaid NICU patient days relative to the total of these days among eligible hospitals as reported by March 1, 2003.

F. Effective July 1, 2013, total payments for IME in combination with other payments for freestanding children's hospitals with greater than 50% Medicaid utilization in 2009 shall not exceed the federal uncompensated care cost limit to which disproportionate share hospital payments are subject. Effective July 1, 2017, IME payments cannot exceed the federal uncompensated care cost limit to which disproportionate share hospital payments are subject, excluding third-party reimbursement for Medicaid eligible patients.

G. Effective July 1, 2018, an additional $362,360 IME payment shall be added to the IME payment calculated in subdivision B 2 of this section for freestanding children's hospitals located in the District of Columbia.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 18, eff. July 1, 2000; amended, Virginia Register Volume 20, Issue 22, eff. August 11, 2004; Volume 21, Issue 23, eff. September 1, 2005; Volume 22, Issue 23, eff. August 23, 2006; Volume 26, Issue 19, eff. July 1, 2010; Volume 27, Issue 19, eff. July 1, 2011; Volume 30, Issue 19, eff. June 18, 2014; Volume 31, Issue 9, eff. February 13, 2015; Volume 34, Issue 11, eff. February 21, 2018; Volume 36, Issue 11, eff. March 5, 2020.

12VAC30-70-300 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 13, Issue 18, eff. July 1, 1997; repealed, Virginia Register Volume 16, Issue 18, eff. July 1, 2000.

12VAC30-70-301 Payment to disproportionate share hospitals

A. Payments to disproportionate share hospitals (DSH) shall be prospectively determined in advance of the state fiscal year to which they apply. The payments shall be made on a quarterly basis and shall be final subject to subsections E and K of this section.

B. Effective July 1, 2014, in order to qualify for DSH payments, DSH eligible hospitals shall have a total Medicaid inpatient utilization rate equal to 14% or higher in the base year using Medicaid days eligible for Medicare DSH defined in 42 USC § 1396r-4(b)(2) or a low income utilization rate defined in 42 USC § 1396r-4(b)(3) in excess of 25%. Eligibility for out-of-state cost reporting hospitals shall be based on total Medicaid utilization or on total Medicaid neonatal intensive care unit (NICU) utilization equal to 14% or higher. Effective July 1, 2018, freestanding children's hospitals located in the District of Columbia shall not be eligible for DSH payments.

C. Effective July 1, 2014, the DSH reimbursement methodology for all hospitals except Type One hospitals is the following:

1. Each hospital's DSH payment shall be equal to the DSH per diem multiplied by each hospital's eligible DSH days in a base year. Days reported in provider fiscal years in state fiscal year (FY) 2011 (available from the Medicaid cost report through the Hospital Cost Report Information System (HCRIS) as of July 30, 2013) will be the base year for FY 2015 prospective DSH payments. DSH shall be recalculated annually with an updated base year. Future base year data shall be extracted from Medicare cost report summary statistics available through HCRIS as of October 1 prior to next year's effective date.

2. Eligible DSH days are the sum of all Medicaid inpatient acute, psychiatric, and rehabilitation days above 14% for each DSH hospital subject to special rules for out-of-state cost reporting hospitals. Eligible DSH days for out-of-state cost reporting hospitals shall be the higher of the number of eligible days based on the calculation in the first sentence of this subdivision times Virginia Medicaid utilization (Virginia Medicaid days as a percent of total Medicaid days) or the Medicaid NICU days above 14% times Virginia NICU Medicaid utilization (Virginia NICU Medicaid days as a percent of total NICU Medicaid days). Eligible DSH days for out-of-state cost reporting hospitals that qualify for DSH but that have less than 12% Virginia Medicaid utilization shall be 50% of the days that would have otherwise been eligible DSH days.

3. Additional eligible DSH days are days that exceed 28% Medicaid utilization for Virginia Type Two hospitals, excluding Children's Hospital of the Kings Daughters (CHKD).

4. The DSH per diem shall be calculated in the following manner:

a. The DSH per diem for Type Two hospitals is calculated by dividing the total Type Two DSH allocation by the sum of eligible DSH days for all Type Two DSH hospitals. For purposes of DSH, Type Two hospitals do not include CHKD or any hospital whose reimbursement exceeds its federal uncompensated care cost limit. The Type Two hospital DSH allocation shall equal the amount of DSH paid to Type Two hospitals in state FY 2014 increased annually by the percent change in the federal allotment, including any reductions as a result of the Patient Protection and Affordable Care Act (Affordable Care Act), Public Law 111-148, adjusted for the state fiscal year. Effective July 1, 2018, the Type Two hospital DSH allocation shall be reduced by the amount of DSH allocated to freestanding children's hospitals located in the District of Columbia.

b. The DSH per diem for state inpatient psychiatric hospitals is calculated by dividing the total state inpatient psychiatric hospital DSH allocation by the sum of eligible DSH days. The state inpatient psychiatric hospital DSH allocation shall equal the amount of DSH paid in state FY 2013 increased annually by the percent change in the federal allotment, including any reductions as a result of the Affordable Care Act, adjusted for the state fiscal year.

c. Effective July 1, 2017, the annual DSH payment shall be calculated separately for each eligible hospital by multiplying each year's state inpatient psychiatric hospital DSH allocation described in subdivision C 4 b of this section by the ratio of each hospital's uncompensated care cost for the most recent DSH audited year completed prior to the DSH payment year to the uncompensated care cost of all state inpatient psychiatric hospitals for the same audited year.

d. The DSH per diem for CHKD shall be three times the DSH per diem for Type Two hospitals.

5. Each year, the department shall determine how much Type Two DSH has been reduced as a result of the Affordable Care Act and adjust the percent of cost reimbursed for outpatient hospital reimbursement.

D. Effective July 1, 2014, the DSH reimbursement methodology for Type One hospitals shall be to pay its uncompensated care costs up to the available allotment. Interim payments shall be made based on estimates of the uncompensated care costs and allotment. Payments shall be settled at cost report settlement and at the conclusion of the DSH audit.

E. Prior to July 1, 2014, hospitals qualifying under the 14% inpatient Medicaid utilization percentage shall receive a DSH payment based on the hospital's type and the hospital's Medicaid utilization percentage.

1. Type One hospitals shall receive a DSH payment equal to:

a. The sum of (i) the hospital's Medicaid utilization percentage in excess of 10.5%, times 17, times the hospital's Medicaid operating reimbursement, times 1.4433 and (ii) the hospital's Medicaid utilization percentage in excess of 21%, times 17, times the hospital's Medicaid operating reimbursement, times 1.4433.

b. Multiplied by the Type One hospital DSH factor. The Type One hospital DSH factor shall equal a percentage that when applied to the DSH payment calculation yields a DSH payment equal to the total calculated using the methodology outlined in subdivision 1 a of this subsection using an adjustment factor of one in the calculation of operating payments rather than the adjustment factor specified in subdivision B 1 of 12VAC30-70-331.

2. Type Two hospitals shall receive a DSH payment equal to the sum of (i) the hospital's Medicaid utilization percentage in excess of 10.5%, times the hospital's Medicaid operating reimbursement, times 1.2074 and (ii) the hospital's Medicaid utilization percentage in excess of 21%, times the hospital's Medicaid operating reimbursement, times 1.2074. Out-of-state cost reporting hospitals with Virginia utilization in the base year of less than 12% of total Medicaid days shall receive 50% of the payment described in this subsection.

F. Hospitals qualifying under the 25% low-income patient utilization rate shall receive a DSH payment based on the hospital's type and the hospital's low-income utilization rate.

1. Type One hospitals shall receive a DSH payment equal to the product of the hospital's low-income utilization in excess of 25%, times 17, times the hospital's Medicaid operating reimbursement.

2. Type Two hospitals shall receive a DSH payment equal to the product of the hospital's low-income utilization in excess of 25%, times the hospital's Medicaid operating reimbursement.

3. Calculation of a hospital's low-income patient utilization percentage is defined in 42 USC § 1396r-4(b)(3).

G. Each hospital's eligibility for DSH payment and the amount of the DSH payment shall be calculated at the time of each rebasing using the most recent reliable utilization data and projected operating reimbursement data available. The utilization data used to determine eligibility for DSH payment and the amount of the DSH payment shall include days for Medicaid recipients enrolled in capitated managed care programs. In years when DSH payments are not rebased in the way described in this section, the previous year's amounts shall be adjusted for inflation.

For freestanding psychiatric facilities licensed as hospitals, DSH payment shall be based on the most recently settled Medicare cost report available before the beginning of the state fiscal year for which a payment is being calculated.

H. Effective July 1, 2010, DSH payments shall be rebased for all hospitals with the final calculation reduced by a uniform percentage such that the expenditures in FY 2011 do not exceed expenditures in FY 2010 separately for Type One and Type Two hospitals. The reduction shall be calculated after determination of eligibility. Payments determined in FY 2011 shall not be adjusted for inflation in FY 2012.

I. Effective July 1, 2013, DSH payments shall not be rebased for all hospitals in FY 2014 and shall be frozen at the payment levels for FY 2013 eligible providers.

J. To be eligible for DSH, a hospital shall also meet the requirements in 42 USC § 1396r-4(d). No DSH payment shall exceed any applicable limitations upon such payment established by 42 USC § 1396r-4(g).

K. If making the DSH payments prescribed in this chapter would exceed the DSH allotment, DMAS shall adjust DSH payments to Type One hospitals. Any DSH payment not made as prescribed in the State Plan as a result of the DSH allotment shall be made upon a determination that an available allotment exists.

L. Effective July, 1, 2020, a supplemental DSH payment shall be made quarterly for non-state government, public acute care hospitals up to its hospital-specific DSH (Omnibus Reconciliation Act 1993 DSH limit) as determined pursuant to 42 USC § 1396r-4(g)(1). The annual payment total shall be based upon the hospital's disproportionate share limit for the most recent year for which the disproportionate share limit has been calculated subject to the availability of DSH funds under the federal allotment of such funds to the department.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 18, eff. July 1, 2000; amended, Virginia Register Volume 20, Issue 22, eff. August 11, 2004; Volume 21, Issue 14, eff. June 6, 2005; Volume 21, Issue 23, eff. September 1, 2005; Volume 22, Issue 25, eff. November 6, 2006; Volume 26, Issue 19, eff. July 1, 2010; Volume 30, Issue 19, eff. June 18, 2014; Volume 33, Issue 19, eff. June 29, 2017; Volume 35, Issue 2, eff. November 1, 2018; Volume 36, Issue 11, eff. March 5, 2020; Volume 37, Issue 7, eff. December 23, 2020.

12VAC30-70-310 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 13, Issue 18, eff. July 1, 1997; repealed, Virginia Register Volume 16, Issue 18, eff. July 1, 2000.

12VAC30-70-311 Hospital specific operating rate per case

A. The hospital specific operating rate per case shall be equal to the labor portion of the statewide operating rate per case, as determined in 12VAC30-70-331, times the hospital's Medicare wage index plus the nonlabor portion of the statewide operating rate per case.

B. For rural hospitals, the hospital's Medicare wage index used in this section shall be the Medicare wage index of the nearest metropolitan wage area or the effective Medicare wage index, whichever is higher.

C. Effective July 1, 2008, and ending after June 30, 2010, the hospital specific operating rate per case shall be reduced by 2.683%.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 18, eff. July 1, 2000; amended, Virginia Register Volume 23, Issue 19, eff. July 1, 2007; Volume 24, Issue 26, eff. October 15, 2008.

12VAC30-70-320 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 13, Issue 18, eff. July 1, 1997; repealed, Virginia Register Volume 16, Issue 18, eff. July 1, 2000.

12VAC30-70-321 Hospital specific operating rate per day

A. The hospital specific operating rate per day shall be equal to the labor portion of the statewide operating rate per day, as determined in subsection A of 12VAC30-70-341, times the hospital's Medicare wage index plus the nonlabor portion of the statewide operating rate per day.

B. For rural hospitals, the hospital's Medicare wage index used in this section shall be the Medicare wage index of the nearest metropolitan wage area or the effective Medicare wage index, whichever is higher.

C. Effective July 1, 2008, and ending after June 30, 2010, the hospital specific operating rate per day shall be reduced by 2.683%.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 18, eff. July 1, 2000; amended, Virginia Register Volume 23, Issue 19, eff. July 1, 2007; Volume 24, Issue 26, eff. October 15, 2008; Volume 26, Issue 12, eff. March 17, 2010; Volume 33, Issue 12, eff. March 8, 2017.

12VAC30-70-330 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 13, Issue 18, eff. July 1, 1997; repealed, Virginia Register Volume 16, Issue 18, eff. July 1, 2000.

12VAC30-70-331 Statewide operating rate per case

A. The statewide operating rate per case shall be equal to the base year standardized operating costs per case, as determined in 12VAC30-70-361, times the inflation values specified in 12VAC30-70-351 times the adjustment factor specified in subsection B of this section.

B. The adjustment factor shall be determined separately for Type One and Type Two hospitals:

1. For Type One hospitals the adjustment factor shall be a calculated percentage that causes the Type One hospital statewide operating rate per case to equal the Type Two hospital statewide operating rate per case;

2. For Type Two hospitals the adjustment factor shall be:

a. 0.7800 effective July 1, 2006, through June 30, 2010.

b. 0.7500 effective July 1, 2010, through September 30, 2010.

c. 0.7800 effective October 1, 2010.

C. The operating rate for critical access hospitals shall be based on an adjustment factor of 1.0, effective July 1, 2019.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 18, eff. July 1, 2000; amended, Virginia Register Volume 20, Issue 22, eff. August 11, 2004; Volume 21, Issue 6, eff. July 1, 2005; Volume 21, Issue 20, eff. July 14, 2005; Volume 23, Issue 20, eff. August 25, 2007; Volume 27, Issue 19, eff. July 1, 2011; Volume 36, Issue 8, eff. January 8, 2020.

12VAC30-70-340 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 13, Issue 18, eff. July 1, 1997; repealed, Virginia Register Volume 16, Issue 18, eff. July 1, 2000.

12VAC30-70-341 Statewide operating rate per day

A. The statewide operating rate per day shall be equal to the base year standardized operating costs per day, as determined in subsection B of 12VAC30-70-371, times the inflation values specified in 12VAC30-70-351 times the adjustment factor specified in subsection B or C of this section.

B. The adjustment factor for acute care rehabilitation cases shall be the one specified in subsection B of 12VAC30-70-331.

C. The adjustment factor for acute care psychiatric cases for:

1. Type One hospitals shall be the one specified in subdivision B 1 of 12VAC30-70-331, times the factor in subdivision 2 this subsection, divided by the factor in subdivision B 2 of 12VAC30-70-331.

2. Type Two hospitals shall be:

a. 0.7800 effective July 1, 2006, through June 30, 2007.

b. 0.8400 effective July 1, 2007, through June 30, 2010.

c. 0.8100 effective July 1, 2010, through September 30, 2010.

d. 0.8400 effective October 1, 2010.

3. For critical access hospitals, effective July 1, 2019, the inpatient operating rate per day shall be based on an adjustment factor equal to 100% of cost reimbursement.

D. Effective July 1, 2009, for freestanding psychiatric facilities, the adjustment factor shall be 1.0000.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 18, eff. July 1, 2000; amended, Virginia Register Volume 23, Issue 19, eff. July 1, 2007; Volume 26, Issue 12, eff. March 17, 2010; Volume 27, Issue 19, eff. July 1, 2011; Volume 36, Issue 8, eff. January 8, 2020.

12VAC30-70-350 (Repealed.)

Historical Notes

Repealed, Virginia Register Volume 16, Issue 18, eff. July 1, 2000.

12VAC30-70-351 Updating rates for inflation

A. Each July, the Virginia moving average values as compiled and published by Global Insight (or its successor), under contract with the department shall be used to update the base year standardized operating costs per case, as determined in 12VAC30-70-361, and the base year standardized operating costs per day, as determined in 12VAC30-70-371, to the midpoint of the upcoming state fiscal year. The most current table available prior to the effective date of the new rates shall be used to inflate base year amounts to the upcoming rate year. Thus, corrections made by Global Insight (or its successor), in the moving averages that were used to update rates for previous state fiscal years shall be automatically incorporated into the moving averages that are being used to update rates for the upcoming state fiscal year.

B. The inflation adjustment for hospital operating rates, disproportionate share hospitals (DSH) payments, and graduate medical education payments shall be eliminated for fiscal year (FY) 2010. The elimination of the inflation adjustments shall not be applicable to rebasing in FY 2011.

C. In FY 2011, hospital operating rates shall be rebased; however the 2008 base year costs shall only be increased 2.58% for inflation. For FY 2011 there shall be no inflation adjustment for graduate medical education (GME) or freestanding psychiatric facility rates. The inflation adjustment shall be eliminated for hospital operating rates, GME payments, and freestanding psychiatric facility rates for FY 2012. The inflation adjustment shall be 2.6% for inpatient hospitals, including hospital operating rates, GME payments, DSH payments, and freestanding psychiatric facility rates for FY 2013, and 0.0% for the same facilities for FY 2014, FY 2015, and FY 2016. For FY 2017, the inflation adjustment for inpatient hospital operating rates, GME, DSH, and freestanding psychiatric hospitals shall be 50% of the adjustment calculated in subsection A of this section. In FY 2018, the inflation adjustment for inpatient hospital operating rates, GME, DSH, and freestanding psychiatric hospitals shall be eliminated for inpatient hospitals. A full inflation adjustment payment shall be made in both FY 2017 and FY 2018 to Virginia freestanding children's hospitals with greater than 50% Medicaid utilization in 2009.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 18, eff. July 1, 2000; amended, Virginia Register Volume 19, Issue 18, eff. July 1, 2003; Volume 26, Issue 12, eff. March 17, 2010; Volume 26, Issue 19, eff. July 1, 2010; Volume 27, Issue 15, eff. April 27, 2011; Volume 29, Issue 23, eff. August 14, 2013; Volume 31, Issue 15, eff. April 22, 2015; Volume 34, Issue 11, eff. February 21, 2018; Volume 34, Issue 23, eff. August 8, 2018.

12VAC30-70-360 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 13, Issue 18, eff. July 1, 1997; repealed, Virginia Register Volume 16, Issue 18, eff. July 1, 2000.

12VAC30-70-361 Base year standardized operating costs per case

A. For the purposes of calculating the base year standardized operating costs per case, base year claims data for all DRG cases, including outlier cases, shall be used. Base year claims data for per diem cases shall not be used. Separate base year standardized operating costs per case shall be calculated for Type One and Type Two hospitals. In calculating the base year standardized operating costs per case, a transfer case shall be counted as a fraction of a case based on the ratio of its length of stay to the arithmetic mean length of stay for cases assigned to the same DRG as the transfer case.

B. Using the data elements identified in subsection E of 12VAC30-70-221, the following methodology shall be used to calculate the base year standardized operating costs per case:

1. The operating costs for each DRG case shall be calculated by multiplying the hospital's total charges for the case by the hospital's operating cost-to-charge ratio, as defined in subsection C of 12VAC30-70-221.

2. The standardized operating costs for each DRG case shall be calculated as follows:

a. The operating costs shall be multiplied by the statewide average labor portion of operating costs, yielding the labor portion of operating costs. Hence, the nonlabor portion of operating costs shall constitute one minus the statewide average labor portion of operating costs times the operating costs.

b. The labor portion of operating costs shall be divided by the hospital's Medicare wage index, yielding the standardized labor portion of operating costs.

c. The standardized labor portion of operating costs shall be added to the nonlabor portion of operating costs, yielding standardized operating costs.

3. The case-mix neutral standardized operating costs for each DRG case shall be calculated by dividing the standardized operating costs for the case by the hospital's case-mix index.

4. The base year standardized operating costs per case shall be calculated by summing the case-mix neutral standardized operating costs for all DRG cases and dividing by the total number of DRG cases.

5. The base year standardized operating costs per case shall be reduced by 5.1% to create a pool for outlier operating payments. Eligibility for outlier operating payments and the amount of the outlier operating payments shall be determined in accordance with 12VAC30-70-261.

C. Because the current cost report format does not separately identify psychiatric costs, claims data shall be used to calculate the base year standardized operating costs per case, as well as the base year standardized operating costs per day described in 12VAC30-70-321. At such time as the cost report permits the separate identification of psychiatric costs and the DRG payment system is recalibrated and rebased, cost report data shall be used to calculate the base year standardized operating costs per case and base year standardized operating costs per day.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 18, eff. July 1, 2000.

12VAC30-70-370 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 13, Issue 18, eff. July 1, 1997; repealed, Virginia Register Volume 16, Issue 18, eff. July 1, 2000.

12VAC30-70-371 Base year standardized operating costs per day

A. For the purpose of calculating the base year standardized operating costs per day, base year claims data for per diem cases shall be used. Base year claims data for DRG cases shall not be used. Separate base year standardized operating costs per day shall be calculated for Type One and Type Two hospitals.

B. Using the data elements identified in subsection E of 12VAC30-70-221, the following methodology shall be used to calculate the base year standardized operating costs per day:

1. The operating costs for each per diem case shall be calculated by multiplying the hospital's total charges for the case by the hospital's operating cost-to-charge ratio, as defined in subsection C of 12VAC30-70-221.

2. The standardized operating costs for each per diem case shall be calculated as follows:

a. The operating costs shall be multiplied by the statewide average labor portion of operating costs, yielding the labor portion of operating costs. Hence, the nonlabor portion of operating costs shall constitute one minus the statewide average labor portion of operating costs times the operating costs.

b. The labor portion of operating costs shall be divided by the hospital's Medicare wage index, yielding the standardized labor portion of operating costs.

c. The standardized labor portion of operating costs shall be added to the nonlabor portion of operating costs, yielding standardized operating costs.

3. The base year standardized operating costs per day for acute care psychiatric cases shall be calculated by summing the standardized operating costs for acute care psychiatric cases and dividing by the total number of acute care psychiatric days. This calculation shall be repeated separately for freestanding psychiatric cases and rehabilitation cases.

C. For general acute care hospitals with psychiatric DPUs, the psychiatric operating cost-to-charge ratio shall be used in the above calculations.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 18, eff. July 1, 2000.

12VAC30-70-380 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 13, Issue 18, eff. July 1, 1997; repealed, Virginia Register Volume 16, Issue 18, eff. July 1, 2000.

12VAC30-70-381 DRG relative weights and hospital case-mix indices

A. For the purposes of calculating DRG relative weights and hospital case-mix indices, base year claims data for all groupable cases shall be used. Base year claims data for ungroupable cases and per diem cases shall not be used. In calculating the DRG relative weights, a transfer case shall be counted as a fraction of a case based on the ratio of its length of stay to the arithmetic mean length of stay for cases assigned to the same DRG as the transfer case.

B. Using the data elements identified in subsection E of 12VAC30-70-221, the following methodology shall be used to calculate the DRG relative weights:

1. The operating costs for each groupable case shall be calculated by multiplying the per diems and ancillary cost-to-charge ratios from each hospital's cost report ending in the state fiscal year used as the base year to the corresponding days and ancillary charges by revenue code for each hospital's groupable cases.

2. The standardized operating costs for each groupable case shall be calculated as follows:

a. The operating costs shall be multiplied by the statewide average labor portion of operating costs, yielding the labor portion of operating costs. Hence, the nonlabor portion of operating costs shall constitute one minus the statewide average labor portion of operating costs times the operating costs.

b. The labor portion of operating costs shall be divided by the hospital's Medicare wage index, yielding the standardized labor portion of operating costs.

c. The standardized labor portion of operating costs shall be added to the nonlabor portion of operating costs, yielding the standardized operating costs.

3. The average standardized cost per DRG shall be calculated by dividing the standardized operating costs for all groupable cases in the DRG by the number of groupable cases classified in the DRG.

4. The average standardized cost per case shall be calculated by dividing the standardized operating costs for all groupable cases by the total number of groupable cases.

5. The average standardized cost per DRG shall be divided by the average standardized cost per case to determine the DRG relative weight.

C. Statistical outliers shall be eliminated from the calculation of the DRG relative weights. Within each DRG, cases shall be eliminated if (i) their standardized costs per case are outside of 3.0 standard deviations of the mean of the log distribution of the standardized costs per case and (ii) their standardized costs per day are outside of 3.0 standard deviations of the mean of the log distribution of the standardized costs per day. To eliminate a case, both conditions must be satisfied.

D. In calculating the DRG relative weights, a threshold of five cases shall be set as the minimum number of cases required to calculate a reasonable DRG relative weight. In those instances where there are five or fewer cases, the department's Medicaid claims data shall be supplemented with Medicaid claims data from another state or other available sources. The DRG relative weights calculated according to this methodology will result in an average case weight that is different from the average case weight before the supplemental claims data was added. Therefore, the DRG relative weights shall be normalized by an adjustment factor so that the average case weight after the supplemental claims data were added is equal to the average case weight before the supplemental claims data were added.

E. The DRG relative weights shall be used to calculate a case-mix index for each hospital. The case-mix index for a hospital is calculated by summing, across all DRGs, the product of the number of groupable cases in each DRG and the relative weight for each DRG and dividing this amount by the total number of groupable cases occurring at the hospital.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 18, eff. July 1, 2000; amended, Virginia Register Volume 34, Issue 11, eff. February 21, 2018.

12VAC30-70-390 (Repealed.)

Historical Notes

Repealed, Virginia Register Volume 16, Issue 18, eff. July 1, 2000.

12VAC30-70-391 Recalibration and rebasing policy

A. The department recognizes that claims experience or modifications in federal policies may require adjustment to the DRG payment system policies provided in this part. The state agency shall recalibrate (evaluate and adjust the DRG relative weights and hospital case-mix indices) and rebase (review and update the base year standardized operating costs per case and the base year standardized operating costs per day) the DRG payment system at least every three years. Recalibration and rebasing shall be done in consultation with the Medicaid Hospital Payment Policy Advisory Council noted in 12VAC30-70-490. When rebasing is carried out, if new rates are not calculated before their required effective date, hospitals required to file cost reports and freestanding psychiatric facilities licensed as hospitals shall be settled at the new rates, for discharges on and after the effective date of those rates, at the time the hospitals' cost reports for the year in which the rates become effective are settled.

B. Effective July 1, 2009, rates for freestanding psychiatric facilities shall be rebased using 2005 cost data as the base year. Future rebasings shall be consistent with rebasing for all other hospitals.

C. Effective July 1, 2010, rates for freestanding psychiatric facilities shall not be rebased.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; Title XIX of the Social Security Act (42 USC § 1396 et seq.).
• Historical Notes: Derived from Virginia Register Volume 16, Issue 18, eff. July 1, 2000; amended, Virginia Register Volume 21, Issue 23, eff. September 1, 2005; Volume 23, Issue 19, eff. July 1, 2007; Volume 26, Issue 12, eff. March 17, 2010; Volume 26, Issue 19, eff. July 1, 2010.

Article 3 Other Provisions for Payment of Inpatient Hospital Services

12VAC30-70-400 Determination of per diem rates

Article 3 Other Provisions for Payment of Inpatient Hospital Services

This section shall be applicable to only those claims for discharges prior to July 1, 1999. Each hospital's revised per diem rate or rates to be used during the transition period (SFY 1997 and SFY 1998) shall be based on the hospital's previous peer group ceiling or ceilings that were established under the provisions of 12VAC30-70-10 through 12VAC30-70-130, with the following adjustments:

1. All operating ceilings will be increased by the same proportion to effect an aggregate increase in reimbursement of $40 million in SFY 1997. This adjustment incorporates in per diem rates the systemwide aggregate value of payment that otherwise would be made through the payment adjustment fund. This adjustment will be calculated using estimated 1997 rates and 1994 days.

2. Starting July 1, 1996, operating ceilings will be increased for inflation to the midpoint of the state fiscal year, not the hospital fiscal year. Inflation shall be based on the DRI-Virginia moving average value as compiled and published by DRI/McGraw-Hill under contract with DMAS, increased by two percentage points per year. The most current table available prior to the effective date of the new rates shall be used.

For services to be paid at SFY 1998 rates, per diem rates shall be adjusted consistent with the methodology for updating rates under the DRG methodology (12VAC30-70-351).

3. There will be no disproportionate share hospital (DSH) per diem.

4. To pay capital cost through claims, a hospital specific adjustment to the per diem rate will be made. At settlement of each hospital fiscal year, this per diem adjustment will be eliminated and capital shall be paid as a pass-through.

5. This methodology shall be used after the transition period to reimburse days of hospital stays with admission dates before July 1, 1996.

6. This methodology shall be used after the transition period to make interim payments until such time as the DRG payment methodology is operational.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 18, eff. July 1, 1997; amended, Virginia Register Volume 16, Issue 18, eff. July 1, 2000.

12VAC30-70-410 State university teaching hospitals

For hospitals that were state owned teaching hospitals on January 1, 1996, all the calculations which support the determination of hospital specific rate per case and rate per day amounts under the prospective payment methodology shall be carried out separately from other hospitals, using cost data taken only from state university teaching hospitals. Rates to be used shall be determined on the basis of cost report and other applicable data from the most recent year for which reliable data are available at the time of rebasing.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 18, eff. July 1, 1997; amended, Virginia Register Volume 16, Issue 18, eff. July 1, 2000.

12VAC30-70-411 Supplemental payments for certain teaching hospitals

A. Qualifying criteria. Qualifying hospitals are the primary teaching hospitals affiliated with a Liaison Committee on Medical Education (LCME) accredited medical school located in Planning District 23 that is a political subdivision of the Commonwealth and an LCME accredited medical school located in Planning District 5 that has a partnership with a public university.

B. Reimbursement methodology. Each qualifying hospital shall receive quarterly supplemental payments for the inpatient services rendered during the quarter equal to the difference between the hospital's Medicaid payments and the hospital's disproportionate share limit (Omnibus Budget Reconciliation Act 93 disproportionate share hospital limit) for the most recent year for which the disproportionate share limit has been calculated divided by four. The supplemental payment amount will be determined prior to the beginning of the fiscal year.

C. Limit. Maximum aggregate payments to all qualifying hospitals shall not exceed the available upper payment limit per state fiscal year (SFY). In SFY 2019, the upper payment limit shall be prorated for the time period these supplemental payments are in effect.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 8, eff. January 1, 2025.

12VAC30-70-415 Reimbursement for freestanding psychiatric hospital services under EPSDT

A. The freestanding psychiatric hospital specific rate per day for psychiatric cases shall be equal to the hospital specific operating rate per day, as determined in subsection A of 12VAC30-70-321 plus the hospital specific capital rate per day for freestanding psychiatric cases.

B. The freestanding psychiatric hospital specific capital rate per day for psychiatric cases shall be equal to the Medicare geographic adjustment factor (GAF) for the hospital's geographic area times the statewide capital rate per day for freestanding psychiatric cases times the percentage of allowable cost specified in 12VAC30-70-271.

C. The statewide capital rate per day for psychiatric cases shall be equal to the weighted average of the GAF-standardized capital cost per day of facilities licensed as freestanding psychiatric hospitals.

D. The capital cost per day of facilities licensed as freestanding psychiatric hospitals shall be the average charges per day of psychiatric cases times the ratio total of capital cost to total charges of the hospital, using data available from Medicare cost report.

E. Effective July 1, 2014, services provided under arrangement, as defined in subdivisions B 6 a and B 6 b of 12VAC30-50-130, shall be reimbursed directly by DMAS, according to the reimbursement methodology prescribed for each provider in 12VAC30-80 or elsewhere in the State Plan, to a provider of services under arrangement if all of the following are met:

1. The services are included in the active treatment plan of care developed and signed as described in subdivision C 4 of 12VAC30-60-25; and

2. The services are arranged and overseen by the freestanding psychiatric hospital treatment team through a written referral to a Medicaid enrolled provider that is either an employee of the freestanding psychiatric hospital or under contract for services provided under arrangement.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 33, Issue 12, eff. March 8, 2017.

12VAC30-70-417 Reimbursement for inpatient psychiatric services in residential treatment facilities (Level C) under EPSDT

A. Effective January 1, 2000, DMAS shall pay for inpatient psychiatric services in residential treatment facilities provided by participating providers under the terms and payment methodology described in this section.

B. Effective January 1, 2000, payment shall be made for inpatient psychiatric services in residential treatment facilities using a per diem payment rate as determined by DMAS based on information submitted by enrolled residential psychiatric treatment facilities. This rate shall constitute direct payment for all residential psychiatric treatment facility services, excluding all services provided under arrangement that are reimbursed in the manner described in subsection D of this section.

C. Enrolled residential treatment facilities shall submit cost reports on uniform reporting forms provided by DMAS at such time as required by DMAS. Such cost reports shall cover a 12-month period. If a complete cost report is not submitted by a provider, DMAS shall take action in accordance with its policies to assure that an overpayment is not being made.

D. Effective July 1, 2014, services provided under arrangement, as defined in subdivisions B 6 a and B 6 b of 12VAC30-50-130, shall be reimbursed directly by DMAS to a provider of services provided under arrangement according to the reimbursement methodology prescribed for that provider type elsewhere in the State Plan if all of the following are met:

1. The services provided under arrangement are included in the active written treatment plan of care developed and signed as described in section 12VAC30-130-890; and

2. The services provided under arrangement are arranged and overseen by the residential treatment facility treatment team through a written referral to a Medicaid enrolled provider that is either an employee of the residential treatment facility or under contract for services provided under arrangement.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 33, Issue 12, eff. March 8, 2017.

12VAC30-70-418 Reimbursement for residential and inpatient substance use treatment services

A. The following substance use disorder treatment services for adults and adolescents are provided in a residential or inpatient setting: (i) clinically managed population-specific high intensity residential service (ASAM Level 3.3); (ii) clinically managed high intensity residential services (adult) and clinically managed medium intensity residential services (adolescent) (ASAM Level 3.5); (iii) medically monitored intensive inpatient services (adult) and medically monitored high intensity inpatient services (adolescent) (ASAM Level 3.7); and (iv) medically managed intensive inpatient services (ASAM Level 4.0).

B. If one of the services in subsection A of this section is furnished to an individual in a freestanding psychiatric hospital or inpatient psychiatric unit of an acute care hospital, reimbursement shall be based on the hospital reimbursement described in 12VAC30-70-241 and the reimbursement of services provided under the arrangement described in 12VAC30-80.

C. If one of the services in subsection A of this section is furnished to an individual in an appropriately licensed residential setting, reimbursement shall be based on the psychiatric residential treatment facility (Level C) reimbursement described in 12VAC30-70-417.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 36, Issue 11, eff. March 5, 2020.

12VAC30-70-420 Reimbursement of noncost-reporting general acute care hospital providers

A. Effective July 1, 2000, noncost-reporting hospitals shall be paid based on the in-state average DRG rates increased by the average capital percentage among hospitals filing cost reports in a recent year.

B. Effective July 1, 2011, out-of-state hospitals shall be reimbursed the lesser of the amount reimbursed by the Medicaid program in the facility's home state or the rate defined in the subsection A of this section.

C. Prior approval must be received from DMAS when a referral has been made for treatment to be received from a nonparticipating acute care facility (in-state or out-of-state). Prior approval will be granted for inpatient hospital services provided out of state to a Medicaid recipient who is a resident of the Commonwealth of Virginia under any one of the following conditions. It shall be the responsibility of the nonparticipating hospital, when requesting prior authorization for the admission of the Virginia resident, to demonstrate that one of the following conditions exists in order to obtain authorization. Services provided out of state for circumstances other than these specified reasons shall not be covered.

1. The medical services must be needed because of a medical emergency;

2. Medical services must be needed and the recipient's health would be endangered if he were required to travel to his state of residence;

3. The state determines, on the basis of medical advice, that the needed medical services, or necessary supplementary resources, are more readily available in the other state; or

4. It is general practice for recipients in a particular locality to use medical resources in another state.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 18, eff. July 1, 1997; amended, Virginia Register Volume 16, Issue 18, eff. July 1, 2000; Volume 18, Issue 6, eff. January 2, 2002; Volume 18, Issue 7, eff. January 16, 2002; Volume 27, Issue 19, eff. July 1, 2011; Volume 32, Issue 10, eff. February 25, 2016.

12VAC30-70-425 Supplemental payments for non-state-government-owned hospitals for inpatient services

A. In addition to payments made elsewhere, effective July 1, 2005, DMAS shall draw down federal funds to cover unreimbursed Medicaid costs for inpatient services provided by non-state-government-owned hospitals as certified by the provider through cost reports.

B. A non-state-government-owned hospital is owned or operated by a unit of government other than a state.

C. Effective July 1, 2018, additional supplemental payments will be issued to each non-state-government-owned acute care hospital for inpatient services provided to Medicaid patients.

1. The supplemental payment shall equal inpatient hospital clam payments times the upper payment limit (UPL) gap percentage.

a. The annual UPL gap percentage is the percentage calculated where the numerator is the difference for each non-state-government-owned acute care hospital between a reasonable estimate of the amount that would be paid under Medicare payment principles for inpatient hospital services provided to Medicaid patients, as calculated in accordance with 42 CFR 447.272, and what Medicaid paid for such services, and the denominator is Medicaid claim payments to each hospital for inpatient hospital services provided to Medicaid patients in the same years used in the numerator.

b. The UPL gap percentage will be calculated annually for each hospital using data for the most recent year for which comprehensive annual data are available and inflated to the state fiscal year for which payments are to be made.

c. Maximum aggregate payments to all qualifying hospitals shall not exceed the available upper payment limit. If inpatient payments for non-state-government-owned hospitals would exceed the upper payment limit, the numerator in the calculation of the UPL gap percentage shall be reduced proportionately.

2. After the close of each quarter, beginning with the July 1, 2018, to September 30, 2018, quarter, each qualifying hospital shall receive supplemental payments for the inpatient services paid during the prior quarter. The supplemental payments for each qualifying hospital for each quarter shall be calculated by multiplying the Medicaid inpatient hospital payments paid in that quarter by the annual UPL gap percentage for each hospital.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 20, Issue 8, eff. January 28, 2004; amended, Virginia Register Volume 22, Issue 23, eff. August 23, 2006; Volume 36, Issue 11, eff. March 5, 2020.

12VAC30-70-426 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 20, Issue 8, eff. January 28, 2004; repealed, Virginia Register Volume 22, Issue 23, eff. August 23, 2006.

12VAC30-70-428 Supplemental payments for private hosptial partners of Type One hospitals

A. Effective for dates of service on or after October 25, 2011, quarterly supplemental payments will be issued to qualifying private hospitals for inpatient services rendered during the quarter. These quarterly supplemental payments will cease for dates of service on or after the effective date of State Plan amendments authorizing increased payments to qualifying hospitals from the Health Care Provider Rate Assessment Fund established pursuant to § 32.1-331.02 of the Code of Virginia and approved by the Centers for Medicare and Medicaid Services.

B. Qualifying criteria. In order to qualify for the supplemental payment, the hospital must be enrolled currently as a Virginia Medicaid provider and must be owned or operated by a private entity in which a Type One hospital has a nonmajority interest.

C. Reimbursement methodology.

1. Hospitals not participating in the Medicaid disproportionate share hospital (DSH) program shall receive quarterly supplemental payments for the inpatient services rendered during the quarter. Each quarterly payment distribution shall occur not more than two years after the year in which the qualifying hospital's entitlement arises. The annual supplemental payments in any fiscal year shall be the lesser of:

a. The difference between each qualifying hospital's inpatient Medicaid billed charges and Medicaid payments the hospital receives for services processed for fee-for-service Medicaid recipients during the fiscal year; or

b. $14,620 per Medicaid discharge for state plan rate year 2012. For future state plan rate years, this number shall be adjusted by inflation based on the Virginia moving average values as compiled and published by Global Insight (or its successor) under contract with the department.

2. Hospitals participating in the Medicaid DSH program shall receive quarterly supplemental payments for the inpatient services rendered during the quarter. Each quarterly payment distribution shall occur not more than two years after the year in which the qualifying hospital's entitlement arises. The annual supplemental payments in any fiscal year shall be the lesser of:

a. The difference between each qualifying hospital's inpatient Medicaid billed charges and Medicaid payments the hospital receives for services processed for fee-for-service Medicaid recipients during the fiscal year;

b. $14,620 per Medicaid discharge for state plan rate year 2012. For future state plan rate years, this number shall be adjusted by inflation based on the Virginia moving average values as compiled and published by Global Insight (or its successor) under contract with the department; or

c. The difference between the limit calculated under § 1923(g) of the Social Security Act and the hospital's DSH payments for the applicable payment period.

D. Limit. Maximum aggregate payments to all qualifying hospitals shall not exceed the available upper payment limit per state fiscal year.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 33, Issue 3, eff. November 17, 2016; amended, Virginia Register Volume 35, Issue 3, eff. November 15, 2018.

12VAC30-70-429 Supplemental payments for private acute care hospitals

A. Starting October 1, 2018, supplemental payments will be issued to qualifying hospitals for inpatient services provided to Medicaid patients.

B. Definitions. The following words and terms when used in this section shall have the following meanings unless otherwise stated:

"Acute care hospital" means any hospital that provides emergency medical services on a 24-hour basis.

"Children's hospital" means a hospital (i) whose inpatients are predominantly younger than 18 years of age and (ii) that is excluded from the Medicare prospective payment system pursuant to the Social Security Act.

"Critical access hospital" means a facility that meets the requirements of the State Medicare Rural Hospital Flexibility Program, 42 USC § 1395i-4, for such designation.

"Freestanding psychiatric and rehabilitation hospital" means a freestanding psychiatric hospital, which means a hospital that provides services consistent with 42 CFR 482.60, or a freestanding rehabilitation hospital, which means a hospital that provides services consistent with 42 CFR 482.56.

"Hospital" means a medical care facility licensed as an inpatient hospital or outpatient surgical center by the Virginia Department of Health or as a psychiatric hospital by the Department of Behavioral Health and Developmental Services.

"Long-stay hospital" means specialty facilities that serve individuals receiving medical assistance who require a higher intensity of nursing care than that which is normally provided in a nursing facility and who do not require the degree of care and treatment that an acute care hospital is designed to provide.

"Long-term acute care hospital" or "LTACH" means an inpatient hospital that provides care for patients who require a length of stay greater than 25 days and is, or proposes to be, certified by Centers for Medicare and Medicaid Services (CMS) as a long-term care inpatient hospital pursuant to 42 CFR Part 412. An LTACH may be either a freestanding facility or located within an existing or host hospital.

"Public hospital" means a hospital that is solely owned by a government or governmental entity.

"Supplemental payment" or "private acute care enhanced payment" means an increased payment to a qualifying hospital up to the upper payment limit gap from the Health Care Provider Rate Assessment Fund as initially authorized in the 2018 Appropriation Act and reauthorized in the subsequent Appropriation Acts.

"Upper payment limit" or "UPL" means the limit on payment for inpatient services for recipients of medical assistance established in accordance with 42 CFR 447.272, and on payment for outpatient services for recipients of medical assistance pursuant to 42 CFR 447.321 for private hospitals. The limit applies only to fee-for-service claims.

"Upper payment limit gap" or "UPL gap" means the difference between the amount of the private acute care hospital upper payment limits estimated for the State Plan rate year using the latest available cost report data, and the amount estimated that would otherwise be paid for the same State Plan rate year pursuant to the State Plan reimbursement methodology for inpatient and outpatient services. The upper payment limit gap shall be updated annually for each rate year.

C. Qualifying criteria. Qualifying hospitals are all in-state private acute care hospitals, excluding public hospitals, freestanding psychiatric and rehabilitation hospitals, children's hospitals, long-stay hospitals, long-term acute care hospitals, and critical access hospitals.

D. Reimbursement methodology. The supplemental payment shall equal inpatient hospital claim payments times the UPL gap percentage.

1. The UPL gap percentage is the percentage calculated when the numerator is the upper payment limit gap for inpatient services for private hospitals and the denominator is Medicaid claim payments to all qualifying hospitals for inpatient hospital services provided to Medicaid patients in the same year used in the numerator.

2. The UPL gap percentage will be calculated annually.

E. Quarterly payments. After the close of each quarter, beginning with the quarter ending December 31, 2018, each qualifying hospital shall receive supplemental payments for the inpatient services paid during that quarter. The supplemental payments for each qualifying hospital for each quarter shall be calculated based on the Medicaid inpatient hospital payments paid in that quarter multiplied by the UPL gap percentage.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 8, eff. January 1, 2025.

12VAC30-70-430 Medicare upper limit

For participating and nonparticipating facilities, the state agency will pay no more in the aggregate for inpatient hospital services than the amount it is estimated would be paid for the services under the Medicare principles of reimbursement, as set forth in 42 CFR 447.253(b)(2) or the lesser of reasonable cost or customary charges in 42 CFR 447.250.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia and Item 322 J of Chapter 912 of the 1996 Virginia Acts of Assembly.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 18, eff. July 1, 1997.

12VAC30-70-435 Lump sum payment

A. In addition to the DRG payment, DMAS shall make a one-time, lump sum payment of $12,243,204 to eligible Virginia hospitals participating in the Medicaid program. This payment shall be made in two equal, semi-annual amounts during fiscal year 2001. For purposes of distribution, each hospital's share of the total amount shall be determined as follows:

1. DMAS shall determine the total operating payments due each hospital for inpatient hospital services provided from January 1, 2000, through June 30, 2000, using hospital claims data from discharges in that period.

2. DMAS shall determine the total operating payments that would have been due each hospital for the same services had the inpatient hospital rates and weights applicable in fiscal year 1998 been continued with inflation for fiscal years 1999 and 2000.

3. The difference between the two values calculated in subdivisions 1 and 2 of this subsection, summed across all hospitals, is the statewide difference. Each hospital-specific difference divided by the statewide difference is the hospital-specific percent share of the statewide difference.

4. The hospital-specific percent share of the statewide difference, times the total funds provided by this appropriation, is the hospital-specific lump sum payment to be paid in two equal semi-annual payments during fiscal year 2001. This payment shall be made as an increase to reimbursement for services provided to Medicaid recipients during state fiscal year 2001. For each hospital, the hospital-specific lump sum payment amount shall be divided by the number of DRG cases in the hospital discharged from July 1, 2000, through December 31, 2000, on or before April 30, 2001. This per case amount shall be paid to each hospital for each of the cases discharged by the hospital during this specified time period, as determined by DMAS.

B. The Department of Medical Assistance Services shall provide the data used, specific calculation, and mechanics of the payment adjustment to the Virginia Medicaid Hospital Policy Advisory Council.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 16, Issue 18, eff. July 1, 2000; amended, Virginia Register Volume 18, Issue 7, eff. January 16, 2002.

12VAC30-70-440 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 13, Issue 18, eff. July 1, 1997; repealed, Virginia Register Volume 14, Issue 15, eff. June 1, 1998.

12VAC30-70-441 Public comment process

The state has in place a public process which complies with the requirements of § 1902(a)(13)(A) of the Social Security Act.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 14, Issue 15, eff. June 1, 1998.

12VAC30-70-450 Cost reporting requirements

Except for noncost-reporting general acute care hospitals and freestanding psychiatric facilities licensed as hospitals, all hospitals shall submit cost reports. All cost reports shall be submitted on uniform reporting forms provided by the state agency and by Medicare. Such cost reports shall cover a 12-month period. Any exceptions must be approved by the state agency. The cost reports are due not later than 150 days after the provider's fiscal year end. All fiscal year end changes must be approved 90 days prior to the beginning of a new fiscal year. If a complete cost report is not received within 150 days after the end of the provider's fiscal year, the program shall take action in accordance with its policies to ensure that an overpayment is not being made. When cost reports are delinquent, the provider's interim rate shall be reduced to zero. The reductions shall start on the first day of the following month when the cost report is due. After the delinquent cost report is received, desk reviewed, and a new prospective rate established, the amounts withheld shall be computed and paid. If the provider fails to submit a complete cost report within 180 days after the fiscal year end, a penalty in the amount of 10% of the balance withheld shall be forfeited to the state agency. The cost report will be judged complete when the state agency has all of the following:

1. Completed cost reporting form or forms provided by DMAS, with signed certification or certifications.

2. The provider's trial balance showing adjusting journal entries.

3. The provider's financial statements including, but not limited to, a balance sheet, a statement of income and expenses, a statement of retained earnings (or fund balance), a statement of changes in financial position, and footnotes to the financial statements. Multi-level facilities shall be governed by subdivision 5 of this subsection.

4. Schedules which reconcile financial statements and trial balance to expenses claimed in the cost report.

5. Hospitals which are part of a chain organization must also file:

a. Home office cost report;

b. Audited consolidated financial statements of the chain organization including the auditor's report in which he expresses his opinion or, if circumstances require, disclaims an opinion based on generally accepted auditing standards, the management report, and footnotes to the financial statements;

c. The hospital's financial statements including, but not limited to, a balance sheet, a statement of income and expenses, a statement of retained earnings (or fund balance), and a statement of cash flows;

d. Schedule of restricted cash funds that identify the purpose of each fund and the amount;

e. Schedule of investments by type (stock, bond, etc.), amount, and current market value.

6. Such other analytical information or supporting documents requested by the state agency when the cost reporting forms are sent to the provider.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 18, eff. July 1, 1997; amended, Virginia Register Volume 16, Issue 18, eff. July 1, 2000.

12VAC30-70-460 Hospital settlement

A. During the transition period claims will be processed and tentative payment made using per diem rates. Settlements will be carried out to ensure that the correct blend of DRG and per diem-based payment is received by each general acute care and rehabilitation hospital and to settle reimbursement of pass-through costs. There shall be no settlement of freestanding psychiatric facilities licensed as hospitals except with respect to disproportionate share hospital (DSH) payment, if necessary (see 12VAC30-70-301 E).

B. The transition blend percentages which determine the share of DRG system and of revised per diem system reimbursement that is applicable in a given period shall change with the change of the state fiscal year, not the hospital fiscal year.

C. If a hospital's fiscal year does not end June 30, its first year ending after June 30, 1996, contains one or more months under the previous methodology, a "split" settlement shall be done of that hospital's fiscal year. Services rendered through June 30, 1996, shall be reimbursed under the previous reimbursement methodology and services rendered after June 30, 1996, will be reimbursed as described in subsection G of this section.

D. For cases subject to settlement under the blend of DRG and per diem methodologies (cases with an admission date after June 30, 1996), the date of discharge determines the year in which any inpatient service or claim related to the case shall be settled. This shall be true for both the DRG and the per diem portions of settlement. Interim claims tentatively paid in one hospital fiscal year that relate to a discharge in a later hospital fiscal year, shall be voided and reprocessed in the latter year so that the interim claim shall not be included in the settlement of the first year, but in the settlement of the year of discharge. An exception to this shall be rehabilitation cases, the claims for which shall be settled in the year of the "through" date of the claim.

E. A single group of cases with discharges in the appropriate time period shall be the basis of both the DRG and the per diem portion of settlement. These cases shall be based on claims submitted and, if necessary corrected by 120 days after the providers FYE. Cases which are based on claims that lack sufficient information to support grouping to a DRG category, and which the hospital cannot correct, shall be settled for purposes of the DRG portion of settlement based on the lowest of the DRG weights.

F. Reimbursement for services in freestanding psychiatric facilities licensed as hospitals shall not be subject to settlement.

G. During the transition period settlements shall be carried out according to the following formulas.

1. Settlement of a hospital's first fiscal year ending after July 1, 1996:

a. Operating reimbursement shall be equal to the sum of the following:

(1) Paid days occurring in the hospital's fiscal year before July 1, 1996, times the per diem in effect before July 1, 1996.

(2) Paid days occurring after June 30, 1996, but in the hospital fiscal year, that are related to admissions that occurred before July 1, 1996, times the revised system per diem that is effective on July 1, 1996.

(3) DRG system payment for DRG and psychiatric cases admitted after June 30, 1996, and discharged within the hospital fiscal year times 1/3.

(4) DRG system payment for rehabilitation claims having a "from" date of July 1, 1996, or later and a "through" date within the hospital fiscal year times 1/3.

(5) Paid days from the cases and claims in subdivisions 1 a (3) and (4) of this subsection, times the revised system per diem that is effective on July 1, 1996, times 2/3.

b. DSH reimbursement shall be equal to paid days from the start of the hospital fiscal year through June 30, 1996, times the DSH per diem effective before July 1, 1996. There shall be no settlement of DSH after July 1, 1996, as the lump sum amount shall be final.

c. Pass-throughs shall be settled as previously based on allowable cost related to days paid in subdivisions 1 a (1), (2), and (5) of this subsection.

2. Settlement of a hospital's second fiscal year ending after July 1, 1996:

a. Operating reimbursement shall be equal to the sum of the following:

(1) Days occurring in the hospital fiscal year related to admissions that occurred before July 1, 1996, times the revised system per diem that is effective at the time.

(2) DRG system payment for DRG and psychiatric cases discharged in the hospital fiscal year, but before July 1, 1997, times 1/3.

(3) DRG system payment for rehabilitation claims having a "through" date within the hospital fiscal year but before July 1, 1997, times 1/3.

(4) Covered days from the cases and claims and in subdivisions 2 b and c of this subsection, times the revised system per diem that is effective on July 1, 1996, times 2/3.

(5) DRG system payment for DRG and psychiatric cases discharged from July 1, 1997, through the end of the hospital fiscal year, times 2/3.

(6) DRG system payment for rehabilitation claims having a "through" date from July 1, 1997, through the end of the hospital fiscal year, times 2/3.

(7) Covered days from the cases and claims and in subdivisions 2 a (5) and (6) of this subsection, times the revised system per diem that is effective on July 1, 1997, times 1/3.

b. DSH reimbursement shall be the predetermined lump sum amount.

c. Pass-throughs shall be settled as previously, based on allowable cost related to days paid in subdivisions 2 a (1), (4), and (7) of this subsection.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 18, eff. July 1, 1997; amended, Virginia Register Volume 16, Issue 18, eff. July 1, 2000.

12VAC30-70-470 Underpayments

When the settlement of a hospital fiscal year indicates that an underpayment has occurred, the state agency shall pay the additional amount to the hospital within 60 days of completion of the settlement.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia and Item 322 J of Chapter 912 of the 1996 Virginia Acts of Assembly.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 18, eff. July 1, 1997.

12VAC30-70-480 Refund of overpayments

A. Lump sum payment. When the settlement of a hospital fiscal year indicates that an overpayment has occurred, full refund shall be remitted with the cost report. In cases where the state agency discovers an overpayment during desk review, field audit, or final settlement, the state agency shall promptly send the first demand letter requesting a lump sum refund. Recovery shall be undertaken unless the hospital disputes the state agency's determination of the overpayment. If the hospital disputes the state agency "s determination, recovery, if any, shall be undertaken after the issue date of any administrative decision issued by the state agency after an informal fact finding conference.

B. Offset. If the hospital has been overpaid for a particular fiscal year and has been underpaid for another fiscal year, the underpayment shall be offset against the overpayment. So long as the hospital has an overpayment balance, any underpayments discovered by subsequent review or audit shall also be used to reduce the remaining amount of the overpayment.

C. Payment schedule. If the hospital cannot refund the total amount of the overpayment (i) at the time it files a cost report indicating that an overpayment has occurred, the hospital shall request an extended repayment schedule at the time of filing or (ii) within 30 days after receiving the DMAS demand letter, the hospital shall promptly request an extended repayment schedule.

DMAS may establish a repayment schedule of up to 12 months to recover all or part of an overpayment or, if a hospital demonstrates that repayment within a 12-month period would create severe financial hardship, the Director of the Department of Medical Assistance Services (the director) may approve a repayment schedule of up to 36 months.

A hospital shall have no more than one extended repayment schedule in place at one time. If an audit later uncovers an additional overpayment, the full amount shall be repaid within 30 days unless the hospital submits further documentation supporting a modification to the existing extended repayment schedule to include the additional amount.

If, during the time an extended repayment schedule is in effect, the hospital withdraws from the program or fails to file a cost report in a timely manner, the outstanding balance shall become immediately due and payable.

When a repayment schedule is used to recover only part of an overpayment, the remaining amount shall be recovered by the reduction of interim payments to the hospital or by lump sum payments.

D. Extension request documentation. In the request for an extended repayment schedule, the hospital shall document the need for an extended (beyond 30 days) repayment and submit a written proposal scheduling the dates and amounts of repayments. If DMAS approves the schedule, DMAS shall send the hospital written notification of the approved repayment schedule, which shall be effective retroactive to the date the hospital submitted the proposal.

E. Interest charge on extended repayment. Interest charges on the unpaid balance of any overpayment shall accrue pursuant to § 32.1-313 of the Code of Virginia from the date the director's determination becomes final.

The director's determination shall be deemed to be final on (i) the due date of any cost report filed by the hospital indicating that an overpayment has occurred, or (ii) the issue date of any notice of overpayment, issued by DMAS, if the hospital does not file an appeal, or (iii) the issue date of any administrative decision issued by DMAS after an informal fact finding conference, regardless of whether the hospital files a further appeal. In any event, interest shall be waived if the overpayment is completely liquidated within 30 days of the date of the final determination. In cases in which a determination of overpayment has been judicially reversed, the hospital shall be reimbursed that portion of the payment to which it is entitled, plus any applicable interest which the hospital paid to DMAS.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia and Item 322 J of Chapter 912 of the 1996 Virginia Acts of Assembly.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 18, eff. July 1, 1997.

12VAC30-70-490 Medicaid Hospital Payment Policy Advisory Council

In order to ensure the ongoing relevance and fairness of the prospective payment system for hospital services, the Director of the Department of Medical Assistance Services shall appoint a Medicaid Hospital Payment Policy Advisory Council. The council shall be composed of four hospital or health system representatives nominated by the Virginia Hospital and Healthcare Association, two senior department staff and one representative each from the Department of Planning and Budget and the Joint Commission on Healthcare. This council will be charged with evaluating and developing recommendations on payment policy changes in areas that include, but are not limited to, the following: (i) utilization reductions directly attributable to the 1995 Appropriations Act utilization initiative and any necessary adjustments to SFY1997 and 1998 DRG rates; (ii) the update and inflation factors to apply to the various components of the delivery system; (iii) the treatment of capital and medical education costs; (iv) the mechanisms and budget implications of recalibration and rebasing approaches; (v) the disproportionate share payment fund and allocation mechanisms; and (vi) the timing and final design of an outpatient payment methodology.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia and Item 322 J of Chapter 912 of the 1996 Virginia Acts of Assembly.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 18, eff. July 1, 1997.

12VAC30-70-500 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 13, Issue 18, eff. July 1, 1997; repealed, Virginia Register Volume 25, Issue 3, eff. November 27, 2008.

Chapter 90 Methods and Standards for Establishing Payment Rates for Long-Term Care

Part I Methods and Standards for Establishing Payment Rates for Long-Term Care

12VAC30-90-10 Methods and standards for establishing payment rates for long-term care

The policy and the method to be used in establishing payment rates for nursing facilities listed in § 1905(a) of the Social Security Act and included in this State Plan for Medical Assistance are described in the following paragraphs.

1. Reimbursement and payment criteria will be established which are designed to enlist participation of a sufficient number of providers of services in the Program so that eligible persons can receive the medical care and services included in the Plan to the extent these are available to the general population.

2. Participation in the Program will be limited to providers of services who accept, as payment in full, the amounts so paid.

3. Payment for care of service will not exceed the amounts indicated to be reimbursed in accord with the policy and the methods described in the Plan and payments will not be made in excess of the upper limits described in 42 CFR 447.253(b)(2).

4. Payments for services to nonstate-owned nursing facilities shall be based on methodologies set out in 12VAC30-90-44 of the Nursing Home Payment System (Part II (12VAC30-90-19 et seq.) of this chapter for nursing facilities and in Subpart XVII (12VAC30-90-264 et seq.) of the Nursing Home Payment System for specialized care facilities.

5. Facilities operated by the Department of Behavioral Health and Developmental Services and facilities operated by the Department of Veterans Services shall be reimbursed retrospectively based on cost.

6. Reimbursement to Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID) shall be retrospective on the basis of reasonable costs in accordance with Medicare principles of reimbursement. Nonstate facilities shall be limited to a ceiling based on the highest as filed rate paid to an ICF/IID institution in state fiscal year 2012 and annually adjusted thereafter with the application of the NF inflation factor, as set out in 12VAC30-90-41 B.

7. Except as specifically modified in this section, Medicare principles of reimbursement, as amended from time to time, shall be used to establish the allowable costs in the rate methodologies. Allowable costs shall be classified in accordance with the DMAS uniform chart of accounts (see 12VAC30-90-270 through 12VAC30-90-276) and shall be identifiable and verifiable by contemporaneous documentation. All matters of reimbursement that are part of the DMAS reimbursement system shall supersede Medicare principles of reimbursement. Wherever the DMAS reimbursement system conflicts with Medicare principles of reimbursement, the DMAS reimbursement system shall take precedence.

8. All nursing facilities and intermediate care facilities shall submit cost reports on the basis of reasonable cost in accordance with the standards and principles set forth in 42 CFR 447.252 as follows:

a. A uniform annual cost report which itemizes allowable cost will be required to be filed within 150 days of each provider's fiscal year end.

b. The determination of allowable costs will be in accordance with Medicare principles as established in the Provider Reimbursement Manual (PRM-15) except where otherwise noted in this Plan.

c. Field audits will be conducted on the cost data submitted by the provider to verify the accuracy and reasonableness of such data. Audits will be conducted for each facility on a periodic basis as determined from internal desk audits and more often as required. Audit procedures are in conformance with SSA standards set forth in PRM-13-2. Internal desk audits are conducted annually within six months of receipt of a completed cost report from the provider.

d. Reports of field audits are retained by the state agency for at least three years following submission of the report.

e. Modifications to the Plan for reimbursement will be submitted as Plan amendments.

f. Covered cost will include such items as:

(1) Cost of meeting certification standards.

(2) Routine services, which include items expense providers normally incur in the provision of services.

(3) The cost of such services provided by related organizations except as modified in the payment system at Subpart 2 (12VAC30-90-29 et seq.) of this chapter.

g. Bad debts, charity and courtesy allowances shall be excluded from allowable cost.

h. Payments will be made to facilities no less than monthly based on claims submitted by the facility.

i. Payments shall be adequate to reimburse in full such actual allowable costs that an economically and efficiently operated facility must incur.

j. In accordance with 42 CFR 447.205, an opportunity for public comment was permitted before final implementation of rate setting processes.

k. Return on equity capital to proprietary providers shall not be an allowable expense.

9. Reimbursement of nonenrolled long-term care facilities.

a. Nonenrolled providers of institutional long-term care services shall be reimbursed based upon the average per diem cost, updated annually, reimbursed to enrolled nursing facility providers.

b. Prior approval must be received from the DMAS for recipients to receive institutional services from nonenrolled long-term care facilities. Prior approval can only be granted:

(1) When the nonenrolled long-term care facility with an available bed is closer to the recipient's Virginia residence than the closest facility located in Virginia with an available bed;

(2) When long-term care special services, such as intensive rehabilitation services, are not available in Virginia; or

(3) If there are no available beds in Virginia facilities.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-02-4.1940, eff. August 12, 1992; amended, Virginia Register Volume 14, Issue 1, eff. December 1, 1997; Volume 18, Issue 18, eff. July 1, 2002; Volume 27, Issue 15, eff. April 27, 2011; Volume 32, Issue 9, eff. February 11, 2016.

12VAC30-90-11 Public comment process

The state has in place a public process which complies with the requirements of § 1902(a)(13)(A) of the Social Security Act.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 14, Issue 15, eff. June 1, 1998.

Part II Nursing Home Payment System Subpart I General

12VAC30-90-19 Supplemental payments for government-owned nursing facilities

Subpart I General

A. In addition to payments made elsewhere, effective July 1, 2005, DMAS shall draw down federal funds to cover unreimbursed Medicaid costs for inpatient services provided by nonstate government-owned nursing facilities as certified by the provider through cost reports. A nonstate government-owned nursing facility is defined as a provider owned or operated by a county, city, or other local government agency, instrumentality, authority, or commission.

B. Effective July 1, 2014, DMAS shall make additional supplemental payments to nonstate government-owned nursing facilities that meet the requirements in subsection A of this section. Quarterly supplemental payment for each facility shall be calculated in the following manner:

1. Annually calculate for each nursing facility what Medicare would have paid for Medicaid services in the base year, which is the most recently available state fiscal year, using the Medicare skilled nursing facility prospective payment system updated for market basket adjustments and other rate changes to the rate year, which is the upcoming state fiscal year.

2. Annually calculate for each facility what Medicaid paid in the base year including any supplemental payments resulting from subsection A of this section updated for inflation and other rate changes to the rate year.

3. Calculate a per diem supplemental payment for each facility by subtracting Medicaid expenditures calculated in subdivision 2 of this subsection from what Medicare would have paid calculated in subdivision 1 of this subsection and dividing the result by the number of paid days for each facility in the base year.

4. At the end of each quarter of the rate year, calculate the number of paid days in the quarter for each facility and multiply it by the per diem supplemental payment for each facility.

C. Maximum aggregate payments to all qualifying nursing facilities shall not exceed the available upper payment in the current state fiscal year.

History

• Statutory Authority: §§ 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 18, eff. July 1, 2001; amended, Virginia Register Volume 22, Issue 23, eff. August 23, 2006; Volume 33, Issue 3, eff. November 17, 2016.

12VAC30-90-20 (Repealed.)

History

• Historical Notes: Derived from VR460-03-4.1940:1 Part I, eff. October 1, 1990; amended, Virginia Register Volume 11, Issue 18, eff. July 1, 1995; Volume 12, Issue 16, eff. July 1, 1996; Volume 13, Issue 1, eff. November 1, 1996; Volume 17, Issue 18, eff. July 1, 2001; Volume 18, Issue 18, eff. July 1, 2002; Volume 27, Issue 15, eff. April 27, 2011; Volume 32, Issue 6, eff. December 31, 2015; repealed, Virginia Register Volume 32, Issue 9, eff. February 11, 2016.

12VAC30-90-21 Reimbursement for individuals in a disaster struck nursing facility

Reimbursement to a disaster struck nursing facility for individuals who must be temporarily evacuated to another facility (resident accepting nursing facility) may continue for up to 30 days after the disaster event. Reimbursement will be the same as if the individual was residing in the disaster struck nursing facility. No other reimbursement will be made to either the disaster struck nursing facility or the resident accepting nursing facility. The disaster struck nursing facility must meet the following conditions:

1. The disaster struck nursing facility must have a contract with the resident accepting nursing facility. The contract must include (i) terms of reimbursement and mechanisms to resolve any contract disputes, (ii) protocols for sharing care and treatment information between the two facilities, and (iii) requirements that both facilities meet all conditions of Medicaid participation determined by the Virginia Department of Health. The Virginia Long-Term Mutual Aid Plan, which includes a Memorandum of Understanding, is an acceptable contract.

2. The disaster struck nursing facility must notify the Department of Medical Assistance Services (DMAS) of the disaster event; maintain records of evacuated individuals with names, dates, and destinations of evacuated residents; and update DMAS on the status of the repairs.

3. The disaster struck nursing facility must determine within 15 days of the event whether individuals will be able to return to the facility within 30 days of the disaster event. If the disaster struck nursing facility determines that it is not able to reopen within 30 days, it must discharge the individuals and work with them to choose admission to other facilities or alternative placements. Nothing shall preclude an individual from asking to be discharged and admitted to another facility or alternative placement. Reimbursement to the disaster struck nursing facility shall cease when an individual is discharged.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 34, Issue 25, eff. September 20, 2018.

12VAC30-90-28 Mid-year fair rental value rate determination

A. New facilities and facilities undergoing a major renovation may apply for a mid-year fair rental value (FRV) rate determination or change if putting into service a major renovation or new beds. Providers are allowed only one mid-year FRV rate change during a state fiscal year (SFY).

1. New facilities. A new nursing facility is defined as a facility that is required to obtain a certificate of occupancy prior to the admittance of a resident. New nursing facilities should file a mid-year FRV report when the facility's certificate of occupancy has been issued. The nursing facility shall submit complete pro forma documentation at least 60 days prior to the certificate of occupancy effective date, and the new FRV rate shall be effective at the beginning of the month following the end of the 60 days, subject to confirmation that the new beds are operational.

a. For any facility whose FRV report has less than 12 months of experience, the department shall develop an occupancy schedule as defined in the nursing facility capital payment methodology (12VAC30-90-36) that represents the average statewide occupancy by month of operation for use in calculating the per diem rate in lieu of a minimum occupancy requirement or actual occupancy. After the initial FRV report filing, actual occupancy data shall be used.

b. New facilities shall use the occupancy schedule developed by the Department of Medical Assistance Services (DMAS) to estimate patient days for their first FRV report until actual patient days are available. The occupancy percentage used to calculate estimated patient days shall be based on the number of months remaining within the calendar year from the month of receipt of the certificate of occupancy. For example, if the certificate of occupancy is received in February, then the number of months remaining in the calendar year would be 11, and the occupancy percentage to use would be 85.84% (see Table 1 in 12VAC30-90-36). The estimated patient days would be equal to the occupancy percentage times the annualized bed days available for the report period.

c. DMAS shall have 15 days from the date of the provider's submission to determine if the filing is complete for purposes of setting a rate for a new facility. The facility shall have 15 days from the date the filing is deemed incomplete to submit the required information. The deadline for setting the rate shall be extended for 30 days after the filing is deemed complete.

2. Major renovations. Facilities undergoing major renovations shall file a mid-year FRV report when there is an increase in capital expenditures of at least $3,000 per total number of beds. The nursing facility shall submit complete pro forma documentation at least 60 days prior to the effective occupancy date and the new rate shall be effective at the beginning of the month following the end of the 60 days, subject to confirmation that the renovated beds are operational. No mid-year rate changes shall be made for an effective date after April 30 of the SFY.

a. Any new beds or major renovations placed in service between the reporting year and the rate year shall be treated as a mid-year rate adjustment. No new FRV rate change will be made after April 30. Rate updates that fall between May 1 and June 30 shall be effective as stated below.

b. DMAS shall have 15 days from the date of the provider's submission to determine if the filing is complete for purposes of setting a rate for a renovated facility. The facility shall have 15 days from the date the filing is deemed incomplete to submit the required information.

c. Providers may propose a phased major renovation subject to approval by DMAS. The phased major renovation may include reductions to available beds. Any modifications to the proposed renovation are also subject to approval by DMAS. Phased major renovations include construction or major renovations that span more than one FRV report period. Only one annual FRV report and one mid-year FRV report can be filed in a SFY to change the plant rate. A mid-year FRV report can be filed only if capital cost per bed increases by a minimum of $3,000 per bed. Major renovation cost may only be included on Schedule R-1 as it is placed into service. Cost cannot be duplicated throughout the project on Schedule R-1. Major renovations for independent and assisted living are not allowed on the Schedule R-1.

B. The following are applicable to new facilities and facilities undergoing major renovation:

1. DMAS shall annualize real estate taxes, property taxes, and property insurance costs that do not represent a full year's cost.

a. Actual paid tax bills shall be provided to support real estate taxes and personal property taxes. When the taxing authority has not invoiced a new facility, building value per the most recent contractor invoice multiplied by the locality's mill rate shall be used to estimate real estate and tax liability for the period. Only the nursing facility's building value can be included in the calculation.

b. Actual paid insurance premiums shall be provided to support property insurance. For newly constructed nursing facilities, a reasonable estimate from the insurance company can be used to document property insurance cost until the first insurance policy and the premium are incurred. Only the nursing facility's property insurance can be included on the schedule.

2. Costs shall be based on currently available documentation at the time but are subject to audit. DMAS may use any reasonable method to estimate costs for which there is inadequate documentation. Reasonable method includes using tax rates from the taxing authority in the location of the facility, the most recent contractor's invoice to determine building cost, and estimates from insurance companies related to the nursing facility portion of the building. Any adjustments based on subsequent year documentation or audit for a current rate year shall be applied beginning July 1 of the next rate year.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 14, eff. April 15, 2021.

Article 1 Transition to New Capital Payment Methodology

12VAC30-90-29 Transition to new capital payment methodology

Subpart 2 Rate Determination Procedures

Article 1 Transition to New Capital Payment Methodology

A. This section provides for a transition to a new capital payment methodology. The methodology that will be phased out for most facilities is described in Article 2 (12VAC30-90-30 et seq.) of this subpart. The methodology that will be phased in for most facilities is described in Article 3 (12VAC30-90-35 et seq.) of this subpart. The terms and timing of the transition are described in this section.

B. Nursing facilities enrolled in the Medicaid program prior to July 1, 2000, shall be paid for capital related costs under a transition policy from July 1, 2000, through June 30, 2012. Facilities and beds paid under the transition policy shall receive payments as follows:

1. During SFY 2001, each facility's capital per diem shall be the facility's capital per diem on June 30, 2000. The methodology under which this per diem is determined shall be the plant cost reimbursement methodology in effect as of June 30, 2000.

2. During SFY 2002, each facility subject to the transition policy shall be paid for capital costs under the methodology described in Article 2 (12VAC30-90-30 et seq.) of this subpart.

3. During SFY 2003 through SFY 2012, each facility subject to the transition policy shall have a capital per diem that is a percentage of the per diem described in Article 2 (12VAC30-90-30 et seq.) of this subpart plus a percentage of the per diem described in Article 3 (12VAC30-90-35 et seq.) of this subpart. The percentage associated with the per diem described in Article 2 shall be 90% for services provided in SFY 2003, 80% for services in SFY 2004, 70% for services in SFY 2005, and so on until the percentage is 0% for services in SFY 2012. The percentage associated with the per diem described in Article 3 shall be equal to 100% minus the percentage associated with the per diem described in Article 2. In SFY 2012, the capital per diem shall be based entirely on the per diem described in Article 3.

C. Return on equity (ROE) for leased facilities shall be phased out along with the methodology described in Article 2 (12VAC30-90-30 et seq.) of this subpart. Leased facilities shall be eligible for ROE after July 1, 2001, only if they were receiving ROE on June 30, 2000.

D. Effective July 1, 2001, newly constructed facilities and new and replacement beds of previously enrolled facilities completed after July 1, 2000, shall be paid entirely under the methodology described in Article 3 (12VAC30-90-35 et seq.) of this subpart without application of the transition policy. However, facilities and beds with COPN applications submitted as of June 30, 2000, shall be subject to the transition policy. Facilities changing ownership after June 30, 2000, shall be paid the per diem rate described in Article 3 if it has been owned by the selling owner for a period of eight years prior to the sale and during that period the facility being sold has not been part of a chain organization consisting of more than two health care facilities. For purposes of this provision, the number of facilities in a chain shall be determined by counting nursing facilities, hospitals, and any other health care facilities that are licensed to admit patients or residents, whether or not they participate in the Medicaid program. Facilities in Virginia and in other states shall be counted in determining the number of facilities in a chain. Facilities shall be considered to form a chain if there is common ownership of the physical assets, or a common operator, or both.

E. Emergency regulations effective July 1, 2000, provided for a facility specific fixed capital per diem applicable to services in SFY 2001 that is not to be adjusted at settlement. After SFY 2001, the per diem that would have been applicable to SFY 2001 under the methodology in Article 2 (12VAC30-90-30 et seq.) of this subpart shall be calculated. If there are two provider fiscal years that overlap SFY 2001, this per diem shall be a combination of the two applicable per diem amounts. If the per diem provided in the emergency regulations is lower than the per diem based on Article 2, the difference, multiplied by the days in SFY 2001, shall be paid to the facility. If the per diem provided in the emergency regulations is higher, the difference, multiplied by the days, shall be collected from the facility in the settlement of the provider year settled after the difference is calculated.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 18, eff. July 1, 2001; amended, Virginia Register Volume 21, Issue 2, eff. November 3, 2004.

Article 2 Plant Cost Component

12VAC30-90-30 Plant cost

A. This article describes a capital payment methodology that will be phased out for most nursing facilities by SFY 2012. The terms and timing of the transition to a different methodology are described in 12VAC30-90-29. The methodology that will eventually replace this one for most facilities is described in Article 3 (12VAC30-90-35 et seq.) of this subpart.

B. Plant cost shall include actual allowable depreciation, interest, rent or lease payments for buildings and equipment as well as property insurance, property taxes and debt financing costs allowable under Medicare principles of reimbursement or as defined herein.

C. Effective July 1, 2001, to calculate the reimbursement rate, plant cost shall be converted to a per diem amount by dividing plant cost by the greater of actual patient days or the number of patient days. Patient days shall be computed as the required occupancy percentage of the daily licensed bed complement during the applicable cost reporting period. The required occupancy percentage means the ratio of nursing facility total patient days to total potential patient days for all available licensed beds. The required occupancy percentage for dates of service on or before June 30, 2013, shall be 90%, and for dates of service on or after July 1, 2013, the required occupancy percentage shall be 88%. For facilities with less than 12 months of occupancy experience, the required occupancy percentage shall be determined from the occupancy schedule in 12VAC30-90-36. For facilities that also provide specialized care services, see subdivision 9 of 12VAC30-90-264 for special procedures for computing the number of patient days required to meet the occupancy requirement.

D. Costs related to equipment and portions of a building or facility not available for patient care related activities are nonreimbursable plant costs.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-03-4.1940:1 Article 1, eff. April 1, 1992; amended, Virginia Register Volume 11, Issue 8, eff. March 1, 1995; Volume 11, Issue 18, eff. July 1, 1995; Volume 12, Issue 16, eff. July 1, 1996; Volume 17, Issue 18, eff. July 1, 2001; Volume 30, Issue 19, eff. June 18, 2014; Volume 37, Issue 14, eff. April 15, 2021.

12VAC30-90-31 New nursing facilities and bed additions

A. Providers shall be required to obtain three competitive bids when (i) constructing a new physical plant or renovating a section of the plant when changing the licensed bed capacity, and (ii) purchasing fixed equipment or major movable equipment related to such projects.

All bids must be obtained in an open competitive market manner, and subject to disclosure to DMAS prior to initial rate setting. (Related parties see 12VAC30-90-51.)

B. Reimbursable costs for building and fixed equipment shall be based upon the 75th percentile square foot costs for NFs published annually in the R.S. Means Building Construction Cost Data as adjusted by the appropriate R.S. Means Square Foot Costs "Location Factor" for Virginia for the locality in which the NF is located. Where the specific location is not listed in the R.S. Means Square Foot Costs "Location Factor" for Virginia, the facility's zip code shall be used to determine the appropriate locality factor from the U.S. Postal Services National Five Digit Zip Code for Virginia and the R.S. Means Square Foot Costs "Location Factors." The provider shall have the option of selecting the construction cost limit which is effective on the date the Certificate of Public Need (COPN) is issued or the date the NF is licensed. Total cost shall be calculated by multiplying the above 75th percentile square foot cost by 385 square feet (the average per bed square footage). Effective July 1, 2007, the construction cost limit for children's ICF/MR facilities having 50 or more beds shall be calculated using up to 750 square feet per bed. Total costs for building additions shall be calculated by multiplying the square footage of the project by the applicable components of the construction cost in the R.S. Means Square Foot Costs, not to exceed the total per bed cost for a new NF. Reasonable limits for renovations shall be determined by the appropriate costs in the R.S. Means Repair and Remodeling Cost Data, not to exceed the total R.S. Means Building Construction Cost Data 75th percentile square foot costs for NFs. 12VAC30-90-28, Mid-year fair rental value rate determination, provides cost documentation requirements for new and renovated nursing homes.

C. New NFs and bed additions to existing NFs must have prior approval under the state's Certificate of Public Need Law and Licensure regulations in order to receive Medicaid reimbursement.

D. However in no case shall allowable reimbursed costs exceed 110% of the amounts approved in the original COPN, or 100% of the amounts approved in the original COPN as modified by any "significant change" COPN, where a provider has satisfied the requirements of the State Department of Health with respect to obtaining prior written approval for a "significant change" to a COPN which has previously been issued (see 12VAC5-220-10 et seq.).

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 16, eff. July 1, 1996; amended, Virginia Register Volume 17, Issue 18, eff. July 1, 2001; Volume 23, Issue 19, eff. July 1, 2007; Volume 37, Issue 14, eff. April 15, 2021.

12VAC30-90-32 Major capital expenditures

A. Major capital expenditures include, but are not limited to, major renovations (without bed increase), additions, modernization, other renovations, upgrading to new standards, and equipment purchases. Major capital expenditures shall be any capital expenditures costing $100,000 or more each, in aggregate for like items, or in aggregate for a particular project. These include purchases of similar type equipment or like items within a one calendar year period (not necessarily the provider's reporting period).

B. Providers (including related organizations as defined in 12VAC30-90-51) shall be required to obtain three competitive bids and if applicable, a Certificate of Public Need before initiating any major capital expenditures. All bids must be obtained in an open competitive manner, and subject to disclosure to the DMAS prior to initial rate setting. (Related parties see 12VAC30-90-51.)

C. Useful life shall be determined by the American Hospital Association's Estimated Useful Lives of Depreciable Hospital Assets (AHA). If the item is not included in the AHA guidelines, reasonableness shall be applied to determine useful life.

D. Major capital additions, modernization, renovations, and costs associated with upgrading the NF to new standards shall be subject to cost limitations based upon the applicable components of the construction cost limits determined in accordance with 12VAC30-90-31 B.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 16, eff. July 1, 1996.

12VAC30-90-33 Financing

A. DMAS shall continue its policy to disallow cost increases due to the refinancing of a mortgage debt, except when required by the mortgage holder to finance expansions or renovations. Refinancing shall also be permitted in cases where refinancing would produce a lower interest rate and result in a cost savings. The total net aggregate allowable costs incurred for all cost reporting periods related to the refinancing cannot exceed the total net aggregate costs that would have been allowable had the refinancing not occurred.

1. Refinancing incentive. Effective July 1, 1991, for mortgages refinanced on or after that date, DMAS will pay a refinancing incentive to encourage nursing facilities to refinance fixed-rate, fixed-term mortgage debt when such arrangements would benefit both the Commonwealth and the providers. The refinancing incentive payments will be made for the 10-year period following an allowable refinancing action, or through the end of the refinancing period should the loan be less than 10 years, subject to a savings being realized by application of the refinancing calculation for each of these years. The refinancing incentive payment shall be computed on the net savings from such refinancing applicable to each provider cost reporting period. Interest expense and amortization of loan costs on mortgage debt applicable to the cost report period for mortgage debt which is refinanced shall be compared to the interest expense and amortization of loan costs on the new mortgage debt for the cost reporting period.

2. Calculation of refinancing incentive. The incentive shall be computed by calculating two index numbers, the old debt financing index and the new debt financing index. The old debt financing index shall be computed by multiplying the term (months) which would have been remaining on the old debt at the end of the provider's cost report period by the interest rate for the old debt. The new debt index shall be computed by multiplying the remaining term (months) of the new debt at the end of the cost reporting period by the new interest rate. The new debt index shall be divided by the old debt index to achieve a savings ratio for the period. The savings ratio shall be subtracted from a factor of 1 to determine the refinancing incentive factor.

3. Calculation of net savings. The gross savings for the period shall be computed by subtracting the allowable new debt interest for the period from the allowable old debt interest for the period. The net savings for the period shall be computed by subtracting allowable new loan costs for the period from allowable gross savings applicable to the period. Any remaining unamortized old loan costs may be recovered in full to the extent of net savings produced for the period.

4. Calculation of incentive amount. The net savings for the period, after deduction of any unamortized old loan and debt cancellation costs, shall be multiplied by the refinancing incentive factor to determine the refinancing incentive amount The result shall be the incentive payment for the cost reporting period, which shall be included in the cost report settlement, subject to per diem computations under 12VAC30-90-30 B and C and 12VAC30-90-55 A.

5. Where a savings is produced by a provider refinancing his old mortgage for a longer time period, DMAS shall calculate the refinancing incentive and payment in accordance with subdivisions 1 through 4 of this subsection for the incentive period. Should the calculation produce both positive and negative incentives, the provider's total incentive payments shall not exceed any net positive amount for the entire incentive period. Where a savings is produced by refinancing with either a principal balloon payment at the end of the refinancing period, or a variable interest rate, no incentive payment will be made, since the true savings to the Commonwealth cannot be accurately computed.

6. All refinancings must be supported by adequate and verifiable documentation and allowable under DMAS regulations to receive the refinancing savings incentive.

7. Balloon loan reimbursement. This subdivision applies to the construction and acquisition of nursing facilities (as defined in 12VAC30-90-31 and 12VAC30-90-34) and major capital expenditures (as defined in 12VAC30-90-32) that are financed with balloon loans. A balloon loan requires periodic payments to be made that do not fully amortize the principal balance over the term of the loan; the remaining balance must be repaid at the end of a specified time period. Demand notes and loans with call provisions shall not be deemed to be balloon loans.

a. Incurred interest. Reimbursement for interest of a balloon loan and subsequent refinancings shall be considered a variable interest rate loan under subsection B of this section.

(1) A standard amortization period of 27 years, from the inception date of the original balloon loan, must be computed by the provider and submitted to DMAS and used as the amortization period for loans for renovation, construction, or purchase of a nursing facility.

(2) A standard amortization period of 15 years, from the inception date of the original balloon loan, must be used as the amortization period for loans on furniture, fixtures, and equipment.

(3) A loan which is used partially for the acquisition of buildings, land, and land improvements and partially for the purchase of furniture, fixtures, and equipment must be prorated for the purpose of determining the amortization period.

b. The allowable interest rate shall be limited to the interest rate upper limit in effect on the date of the original balloon loan, unless another rate is allowable under subsection B of this section.

c. Financing costs. The limitations on financing costs set forth in subsection B of this section shall apply to balloon loans. Financing costs exceeding the limitations set forth in these sections shall be allowed to the extent that such excess financing costs may be offset by any available interest savings.

(1) A 27-year amortization period must be used for deferred financing costs associated with the construction or purchase of a nursing facility.

(2) A 15-year amortization period must be used for deferred financing costs associated with financing of furniture, fixtures, and movable equipment.

(3) Financing costs associated with a loan used partially for the acquisition of buildings, land, and land improvements and partially for the purchase of furniture, fixtures, and equipment must be prorated for determination of the amortization period.

d. Cumulative credit computation. The computation of allowable interest and financing costs for balloon loans shall be calculated using the following procedures:

(1) A standard amortization schedule of allowable costs based upon the upper limits for interest and financing costs shall be computed by the provider and submitted to DMAS for the applicable 27-year or 15-year periods on the original balloon loan.

(2) For each cost reporting period, the provider shall be allowed the lesser of loan costs (interest and financing costs) computed in accordance with subdivision 7 a of this subsection, or the actual loan costs incurred during the period.

(3) To the extent that there is a "credit" created by the actual loan costs being less than the loan costs computed on the amortization schedule in some periods, the provider may recover any otherwise allowable costs which result from the refinancing, extension, or renewal of the balloon loan, and any loan costs which have been disallowed because the loan costs are over the limitation for some periods. However, the cumulative actual loan cost reimbursement may not exceed the cumulative allowable loan cost as computed on the amortization schedule to that date.

(4) In refinancing or refinancings of the original balloon loan which involve additional borrowings in excess of the balance due on the original balloon loan, the excess over the balance due on the balloon loan shall be treated as new debt subject to the DMAS financing policies and regulations. Any interest and financing costs incurred on the refinancing shall be allocated pro rata between the refinancing of the balloon loan and the new debt.

(5) In the event of a sale of the facility, any unused balance of cumulative credit or cumulative provider excess costs would follow the balloon loan or the refinancing of the balloon loan if the balloon loan or its refinancing is paid by the buyer under the same terms as previously paid by the seller. Examples of this are (i) the buyer assumes the existing instrument containing the same rates and terms by the purchaser; or (ii) the balance of the balloon loan or its refinancings is financed by the seller to the buyer under the same rates and terms of the existing loan as part of the sale of the facility. If the loan is otherwise paid in full at any time and the facility is sold before the full 27-year or 15-year amortization period has expired, the balance of unused cumulative credit or cumulative provider excess costs shall expire and not be considered an allowable cost.

e. In accordance with subdivision 5 of this subsection, no refinancing incentive shall be available for refinancings, extensions, or renewals of balloon loans.

f. The balloon loan and refinancing of the balloon loan shall be subject to all requirements for allowable borrowing, except as otherwise provided by this subsection.

B. Interest rate upper limit. Financing for all NFs and expansions which require a COPN and all renovations and purchases shall be subject to the following limitations:

1. Interest expenses for debt financing which is exempt from federal income taxes shall be limited to:

The average weekly rates for Baa municipal rated bonds as published in Cragie Incorporated Municipal Finance Newsletter as published weekly (Representative reoffering from general obligation bonds), plus one percentage point (100 basis points), during the week in which commitment for construction financing or closing for permanent financing takes place.

2. a. Effective on and after July 1, 1990, the interest rate upper limit for debt financing by NFs that are subject to prospective reimbursement shall be the average of the rate for 10-year and 30-year U.S. Treasury Constant Maturities, as published in the weekly Federal Reserve Statistical Release (H.15), plus two percentage points (200 basis points).

This limit (i) shall apply only to debt financing which is not exempt from federal income tax, and (ii) shall not be available to NF's which are eligible for such tax exempt financing unless and until a NF has demonstrated to DMAS that the NF failed, in a good faith effort, to obtain any available debt financing which is exempt from federal income tax. For construction financing, the limit shall be determined as of the date on which commitment takes place. For permanent financing, the limit shall be determined as of the date of closing. The limit shall apply to allowable interest expenses during the term of the financing.

b. The new interest rate upper limit shall also apply, effective July 1, 1990, to construction financing committed to or permanent financing closed after December 31, 1986, but before July 1, 1990, which is not exempt from federal income tax. The limit shall be determined as of July 1, 1990, and shall apply to allowable interest expenses for the term of the financing remaining on or after July 1, 1990.

3. Variable interest rate upper limit.

a. The limitation set forth in subdivisions 1 and 2 of this subsection shall be applied to debt financing which bears a variable interest rate as follows. The interest rate upper limit shall be determined on the date on which commitment for construction financing or closing for permanent financing takes place, and shall apply to allowable interest expenses during the term of such financing as if a fixed interest rate for the financing period had been obtained. A "fixed rate loan amortization schedule" shall be created for the loan period, using the interest rate cap in effect on the date of commitment for construction financing or the date of closing for permanent financing.

b. If the interest rate for any cost reporting period is below the limit determined in subdivision 3 a of this subsection, no adjustment will be made to the provider's interest expense for that period, and a "carryover credit" to the extent of the amount allowable under the "fixed rate loan amortization schedule" will be created, but not paid. If the interest rate in a future cost reporting period is above the limit determined in subdivision 3 a of this subsection, the provider will be paid this "carryover credit" from prior period(s), not to exceed the cumulative carryover credit or its actual cost, whichever is less.

c. The provider shall be responsible for preparing a verifiable and auditable schedule to support cumulative computations of interest claimed under the "carryover credit," and shall submit such a schedule with each cost report.

4. The limitation set forth in subdivisions 1, 2, and 3 of this subsection shall be applicable to financing for land, buildings, fixed equipment, major movable equipment, working capital for construction and permanent financing.

5. Where bond issues are used as a source of financing, the date of sale shall be considered as the date of closing.

6. The aggregate of the following costs shall be limited to 5.0% of the total allowable project costs:

a. Examination Fees.

b. Guarantee Fees.

c. Financing Expenses (service fees, placement fees, feasibility studies, etc.).

d. Underwriters Discounts.

e. Loan Points.

7. The aggregate of the following financing costs shall be limited to 2.0% of the total allowable project costs:

a. Legal Fees.

b. Cost Certification Fees.

c. Title and Recording Costs.

d. Printing and Engraving Costs.

e. Rating Agency Fees.

C. DMAS shall allow costs associated with mortgage life insurance premiums in accordance with § 2130 of the HCFA-Pub. 15, Provider Reimbursement Manual (PRM-15).

D. Interest expense on a debt service reserve fund is an allowable expense if required by the terms of the financing agreement. However, interest income resulting from such fund shall be used by DMAS to offset interest expense.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia and Item 319 (II) of Chapter 1073 of the 2000 Acts of Assembly.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 16, eff. July 1, 1996; amended, Virginia Register Volume 17, Issue 18, eff. July 1, 2001.

12VAC30-90-34 Purchases of nursing facilities (NF)

A. In the event of a sale of a NF, the purchaser must have a current license and certification to receive DMAS reimbursement as a provider and must notify DMAS of the sale within 30 days of the date legal title passes to the purchaser. The notification shall include:

1. That a sale or transfer is about to be made or has already occurred;

2. The location and general description of the property; and

3. The names and addresses of the transferee and transferor and all such business names and addresses of the transferor for the last three years.

B. The following reimbursement principles shall apply to the purchase of a NF:

1. The allowable cost of a bona fide purchase of an existing nursing facility (whether or not the parties to the sale are, were, or will be providers of Medicaid services shall be the seller's allowable depreciated historical cost (net book value) as determined for Medicaid reimbursement. The amount of allowable debt or borrowing to finance such a purchase shall be limited to the greater of the amount of the seller's net book value of the assets purchased, or the seller's related allowable debt, both as determined for Medicaid reimbursement plus required financing costs limited in accordance with the provisions of 12VAC30-90-33 B 6 and B 7.

2. For purposes of Medicaid reimbursement, a "bona fide" purchase shall mean a transfer of title and possession for consideration between parties that are not related. Parties shall be deemed to be "related" if they are related by reasons of common ownership or control. If the parties are members of an immediate family, the sale shall be presumed to be between related parties if the ownership or control by immediate family members, when aggregated together, meets the definitions of "common ownership" or "control." See 12VAC30-90-51 C for definitions of "common ownership," "control," "immediate family," and "significant ownership or control."

3. The useful life of the fixed assets of the facility shall be the seller's remaining depreciable lives as determined for Medicaid reimbursement.

4. The seller must file a final cost report within 150 days of the date of sale.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia and Item 319 (II) of Chapter 1073 of the 2000 Acts of Assembly.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 16, eff. July 1, 1996; amended, Virginia Register Volume 17, Issue 18, eff. July 1, 2001.

Article 3 Fair Rental Value Capital Payment System

12VAC30-90-35 General applicability

Article 3 Fair Rental Value Capital Payment System

This article describes a capital payment methodology that will be phased in for most nursing facilities by SFY 2012. The terms and timing of the transition to a different methodology are described in 12VAC30-90-29. The methodology that this one will replace for most facilities is described in Article 2 (12VAC30-90-30 et seq.) of this subpart.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia and Item 319 (II) of Chapter 1073 of the 2000 Acts of Assembly.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 18, eff. July 1, 2001.

12VAC30-90-36 Nursing facility capital payment methodology

A. Applicability. The capital payment methodology described in this article shall be applicable to freestanding nursing facilities and specialized care facilities but not to hospital-based facilities. Hospital-based facilities shall continue to be reimbursed under the methodology contained in Article 2 (12VAC30-90-30 et seq.) of this subpart. For purposes of this provision, a hospital-based nursing facility shall be one for which a combined cost report is submitted on behalf of both the hospital and the nursing facility.

B. Definitions. The following words and terms when used in this article shall have the following meaning unless the context clearly indicates otherwise:

"Capital costs" means costs that include the cost elements of depreciation, interest, financing costs, rent and lease costs for property, building and equipment, property insurance and property taxes.

"Date of acquisition" means the date legal title passed to the buyer. If a legal titling date is not determinable for a nursing facility building, date of acquisition shall be considered to be the date a certificate of occupancy was issued by the appropriate licensing or building inspection agency of the locality where the nursing facility is located.

"Facility average age" means for a facility the weighted average of the ages of all capitalized assets of the facility, with the weights equal to the expenditures for those assets. The calculation of average age shall take into account land improvements, building and fixed equipment, and major movable equipment. The basis for the calculation of average age shall be the schedule of assets submitted annually to the department in accordance with the provisions of this section.

"Facility imputed gross square feet" means a number that is determined by multiplying the facility's number of nursing facility beds licensed by the Virginia Department of Health by the imputed number of gross square feet per bed. The imputed number of gross square feet per bed shall be 461 for facilities of 90 or fewer beds, and 438 for facilities of more than 90 beds. The number of licensed nursing facility beds shall be the number on the last day of the provider's most recent fiscal year end for which a cost report has been filed.

"Factor for land and soft costs" means a factor equaling 1.429 that adjusts the construction cost amount to recognize land and capitalized costs associated with construction of a facility that is not part of the R.S. Means construction cost amount.

"Fixed capital replacement value" means an amount equal to the R.S. Means 75th percentile nursing home construction cost per square foot, times the applicable R.S. Means historical cost index factor, times the factor for land and soft costs, times the applicable R.S. Means location factor times facility imputed gross square feet.

"FRV depreciation rate" means a depreciation rate equal to 2.86% per year.

"Hospital-based facility" means one for which a single combined Medicare cost report is filed that includes the costs of both the hospital and the nursing home.

"Major renovation" means an increase in capital of $3,000 per bed.

"Movable capital replacement value" means a value equal to $3,475 per bed in SFY 2001, and shall be increased each July 1 by the same R.S. Means historical cost index factor that is used to calculate the fixed capital replacement value. Each year's updated movable capital replacement value shall be used in the calculation of each provider's rate for the provider year beginning on or after the date the new value becomes effective.

"Occupancy schedule" means a table created to represent the average statewide occupancy by month of operation for use in calculating the per diem rate in lieu of a minimum occupancy requirement or actual occupancy for facilities with less than 12 months of experience. The occupancy schedule is shown in Table 1.

| Table 1. Occupancy Schedule | | | --- | --- | | Initial Operating Period | Occupancy Percentage | | 3 Months | 58.10% | | 4 Months | 65.68% | | 5 Months | 70.01% | | 6 Months | 73.69% | | 7 Months | 76.69% | | 8 Months | 79.23% | | 9 Months | 81.60% | | 10 Months | 83.88% | | 11 Months | 85.84% | | 12 Months | 88.00% |

"R.S. Means 75th percentile nursing construction cost per square foot" means the 75th percentile value published in the 59th Annual Edition of the R.S. Means Building Construction Cost Data, 2001. In the 2000 edition of the R.S. Means publication this value is $110, which is reported as a January 2000 value.

"R.S. Means historical cost index factor" means the ratio of the two most recent R.S. Means Historical Cost Indexes published in the 59th Annual Edition of the R.S. Means Building Construction Cost Data, 2001. In the 2000 edition of this R.S. Means publication these two values are 117.6 (for 1999) and 115.1 (for 1998). The ratio of these values, and therefore the factor to be used, would be 1.022. This factor would be used to adjust the January 2000 value for the one year of change from January 2000 to January 2001, the mid-point of the prospective rate year (SFY 2001). The resulting cost value that would be used in SFY 2001 is $112.42. The indexes used in this calculation do not match the time period for which a factor is needed. They relate to 1998 and 1999, while 2000 and 2001 would be ideal. However, R.S. Means does not publish index forecasts, so the most recent available indexes shall be used.

"R.S. Means location factors" means those published in the 22nd Annual Edition of the R.S. Means Square Foot Costs, 2001. The 2000 location factors are shown in Table 2. The calculation will use the most recently available location factors, which will also be published on the Department of Medical Assistance Services (DMAS) website.

| TABLE . 2. R.S. MEANS COMMERCIAL CONSTRUCTION COST LOCATION FACTORS (2000). | | | | --- | --- | --- | | Zip Code | Principal City | Location Factor | | 220–221 | Fairfax | 0.90 | | 222 | Arlington | 0.90 | | 223 | Alexandria | 0.91 | | 224–225 | Fredericksburg | 0.85 | | 226 | Winchester | 0.80 | | 227 | Culpeper | 0.80 | | 228 | Harrisonburg | 0.77 | | 229 | Charlottesville | 0.82 | | 230–232 | Richmond | 0.85 | | 233–235 | Norfolk | 0.82 | | 236 | Newport News | 0.82 | | 237 | Portsmouth | 0.81 | | 238 | Petersburg | 0.84 | | 239 | Farmville | 0.74 | | 240–241 | Roanoke | 0.77 | | 242 | Bristol | 0.75 | | 243 | Pulaski | 0.70 | | 244 | Staunton | 0.76 | | 245 | Lynchburg | 0.77 | | 246 | Grundy | 0.70 |

"Rental rate" means for a prospective year a rate equal to two percentage points plus the yield on U.S. Treasury Bonds with maturity over 10 years, averaged over the most recent three calendar years for which data are available, as published by the Federal Reserve (Federal Reserve Statistical Release H.15 Selected Interest Rates (www.Federalreserve.gov/releases/)). The rate will be published and distributed to providers annually. Changes in the rental rate shall be effective for the provider's fiscal year beginning on or after July 1. Rental rates may not fall below 9.0% or exceed 11% and will be updated annually on or about July 1 each year. Effective July 1, 2010, through September 30, 2010, the floor for the nursing facility rental rates may not fall below 8.75%. Effective October 1, 2010, through June 30, 2011, the floor for the nursing facility rental rates may not fall below 9.0%. Effective July 1, 2011, through June 30, 2012, the floor for the nursing facility rental rates may not fall below 8.0%. Effective July 1, 2012, through June 30, 2014, the floor for the nursing facility rental rates may not fall below 8.5%. Effective July 1, 2014, the floor for the nursing facility rental rates may not fall below 8.0%. The rate will be published and distributed to providers annually.Changes in the rental rate shall be effective for the provider's fiscal year beginning on or after July 1. Effective July 1, 2014, the rental rate shall be effective for the state fiscal year.

"Required occupancy percentage" means the ratio of nursing facility total patient days to total potential patient days for all available licensed beds. The required occupancy percentage shall be 90% for dates of service on or before June 30, 2013. The required occupancy percentage for dates of service on or after July 1, 2013, shall be 88%. Facilities whose fair rental value report indicates less than 12 months of experience must use the occupancy schedule shown in Table 1 to determine the required occupancy percentage.

"SFY" means State Fiscal Year (July 1 through June 30).

C. Fair rental value (FRV) payment for capital.

1. Effective for dates of service on or after July 1, 2001, DMAS shall pay nursing facility capital related costs under a FRV methodology. The payment made under this methodology shall be the only payment for capital related costs, and no separate payment shall be made for depreciation or interest expense, lease costs, property taxes, insurance, or any other capital related cost, including home office capital costs. This payment is considered to cover costs related to land, buildings and fixed equipment, major movable equipment, and any other capital related item. This shall be the case regardless of whether the property is owned or leased by the operator.

2. FRV rate year. The FRV payment rate shall be a per diem rate determined each year for each facility using the most recent available data from settled cost reports, or from other verified sources as specified herein. The per diem rate shall be determined prospectively and shall apply for the entire fiscal year. Each provider shall receive a new capital per diem rate each year effective at the start of the provider's fiscal year, except that the capital per diem rate shall be revised for the rental rate changes effective July 1, 2010, through June 30, 2012. Data elements that are provider specific shall be revised at that time and shall rely on the settled cost report and schedule of assets of the previous year. Data elements that are not provider specific, including those published by R.S. Means and the rental rate, shall be determined annually on or about July 1, and shall apply to provider fiscal years beginning on or after July 1. That is, each July 1 DMAS shall determine the R.S. Means values and the rental rate, and these shall apply to all provider fiscal years beginning on or after July 1. Effective July 1, 2014, the FRV rate year shall be the same as the state fiscal year.

3. Mid-year FRV rate change. Facilities requiring a mid-year FRV rate change must follow the procedures as specified in 12VAC30-90-28.

4. The capital per diem rate for hospital-based nursing facilities shall be the last settled capital per diem.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 18, eff. July 1, 2001; amended, Virginia Register Volume 27, Issue 19, eff. July 1, 2011; Volume 29, Issue 23, eff. August 14, 2013; Volume 30, Issue 19, eff. June 18, 2014; Volume 32, Issue 9, eff. February 11, 2016; Volume 37, Issue 14, eff. April 15, 2021.

12VAC30-90-37 Calculation of FRV per diem rate for capital; calculation of FRV rental amount; change of ownership

A. Calculation of FRV per diem rate for capital.

1. The facility FRV per diem rate shall be equal to the sum of the facility FRV rental amount and the facility's allowable property tax and insurance cost from the most recent settled cost report, divided by the greater of actual patient days or the required occupancy percentage of the potential patient days for all licensed beds throughout the cost reporting period. For facilities that also provide specialized care services, see subdivision 9 of 12VAC30-90-264 for special procedures for computing the number of patient days required to meet the required occupancy percentage requirement.

2. Effective July 1, 2014, facilities shall be required to submit a calendar year FRV report covering both NF and specialized care beds to be used to set a prospective FRV rate effective the following July 1for both the NF and the specialized care facility. The calendar year FRV report shall be submitted by the end of February following the end of the calendar year. FRV reports shall be settled within 90 days of filing the FRV report. For late FRV reports, the prospective rate may be effective 90 days after the date of filing even if after July 1. No capital rate shall be paid between July 1 and the effective date of the prospective FRV rate for a late report.

3. New nursing facilities or major renovations that qualify for mid-year FRV rate adjustments must follow pro forma submission procedures as specified in 12VAC30-90-28.

B. Calculation of FRV rental amount. The facility FRV rental amount shall be equal to the facility prospective year total value times the rental rate. Effective July 1, 2014, fair rental value per diem rates for the prospective state fiscal year shall be calculated for all freestanding nursing facilities based on the prior calendar year information aged to the state fiscal year and using R.S. Means factors and rental rates corresponding to the state fiscal year. There shall be no separate calculation for beds subject to or not subject to transition.

1. The facility prospective year total value shall be equal to the facility prospective year replacement value minus FRV depreciation. FRV depreciation equals the prospective year replacement value multiplied by the product of facility average age and the depreciation rate. FRV depreciation cannot exceed 60% of the prospective year replacement value.

2. The facility prospective year replacement value shall be equal to the fixed capital replacement value plus the movable equipment replacement value.

C. Change of ownership. As provided in connection with schedule of assets reporting, the sale of nursing facility assets after June 30, 2000, shall not result in a change to the schedule of assets or to the calculation of average age for purposes of reimbursement under the FRV methodology. Therefore, any sale or transfer of assets after this date shall not affect the FRV per diem rate.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 18, eff. July 1, 2001; amended, Virginia Register Volume 30, Issue 19, eff. June 18, 2014; Volume 32, Issue 9, eff. February 11, 2016; Volume 37, Issue 14, eff. April 15, 2021.

12VAC30-90-38 Schedule of assets reporting

A. For the calculation of facility average age, the department shall use a "schedule of assets" that lists, by year of acquisition, the allowable acquisition cost of facilities' assets, including land improvements, buildings and fixed equipment, and major movable equipment. This schedule shall be submitted annually by the provider on forms to be provided by the department, and shall be audited by the department. The principles of reimbursement for plant cost described in Article 2 (12VAC30-90-30 et seq.) of this subpart shall be used to determine allowable cost.

B. The schedule of assets used in the calculation of average age shall be submitted with the provider's cost report.

C. Facilities failing to submit the schedule of assets timely shall have their nursing facility per diem rate set to zero.

D. Capital expenditures are to be included on the schedule of assets. These do not include land purchases, but do include land improvements, renovations, additions, upgrading to new standards, and equipment purchases. Capital expenditures shall be capital related expenditures costing $50,000 or more each, in aggregate for like items, or in aggregate for a particular project. For facilities with 30 or fewer beds, an amount of $25,000, rather than $50,000, shall apply. The limits of $50,000 and $25,000 shall apply only to expenditures after July 1, 2000. For these purposes, like items means those items acquired within a 12-month period that are classified in one of the categories of land improvements, building improvements, or movable equipment. Additionally, capital-related expenditures that are part of a particular project may be included on the schedule of assets for the cost reporting that is after the date the assets have been placed into service, whether all the required $50,000 threshold of costs of the ongoing project have been incurred as of the reporting date.

E. Items reportable on the schedule of assets may be removed only when disposed of.

F. Acquisition costs related to any sale or change in the ownership of a nursing facility or the assets of a nursing facility shall not be included in the schedule of assets if the transaction occurred after June 30, 2000. Whether such a transaction is the result of a sale of assets, acquisition of capital stock, merger, or any other type of change in ownership, related costs shall not be reported on the schedule of assets.

G. In addition to verifying the schedule of assets, audits of NF allowable capital costs shall continue to be performed in accordance with regulations described in Article 2.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 18, eff. July 1, 2001; amended, Virginia Register Volume 18, Issue 18, eff. July 1, 2002.

12VAC30-90-39 Purchases of nursing facilities (NF)

A. In the event of a sale of a NF, the purchaser must have a current license and certification to receive DMAS reimbursement as a provider and must notify DMAS of the sale within 30 days of the date legal title passes to the purchaser. The notification shall include:

1. That a sale or transfer is about to be made or has already occurred;

2. The location and general description of the property;

3. The names and addresses of the transferee and transferor and all such business names and addresses of the transferor for the last three years.

B. The seller must file a final cost report within 150 days of the date of the facility sale.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia and Item 319 (II) of Chapter 1073 of the 2000 Acts of Assembly.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 18, eff. July 1, 2001.

Article 4 Operating Cost Component

12VAC30-90-40 Operating cost

Article 4 Operating Cost Component

Effective July 1, 2001, operating cost shall be the total allowable inpatient cost less plant cost or capital, as appropriate, and NATCEPs costs. See Subpart VII (12VAC30-90-170 et seq.) of this part for rate determination procedures for NATCEPs costs. Operating cost shall be made up of direct patient care operating cost and indirect patient care operating cost. Direct patient care operating cost is defined in 12VAC30-90-271. Indirect patient care operating cost includes all operating costs not defined as direct patient care operating costs or NATCEPs costs or the actual charges by the Central Criminal Records Exchange for criminal records checks for nursing facility employees (see 12VAC30-90-272). For purposes of calculating the reimbursement rate, the direct patient care operating cost per day shall be the Medicaid portion of the direct patient care operating cost divided by the nursing facility's number of Medicaid patient days in the cost reporting period. The indirect patient care operating cost per day shall be the Medicaid portion of the indirect patient care operating cost divided by the greater of the actual number of Medicaid patient days in the cost reporting period, or the required occupancy percentage of the potential patient days for all licensed beds throughout the cost reporting period times the Medicaid utilization percentage. The required occupancy percentage for dates of service on or before June 30, 2013, shall be 90%, and for dates of service on or after July 1, 2013, shall be 88%. For facilities that also provide specialized care services, see subdivision 9 of 12VAC30-90-264 for special procedures for computing the number of patient days required to meet the occupancy percentage requirement.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-03-4.1940:1 Article 2, eff. July 5, 1991; amended, Virginia Register Volume 11, Issue 18, eff. July 1, 1995; Volume 12, Issue 16, eff. July 1, 1996; Volume 17, Issue 18, eff. July 1, 2001; Volume 18, Issue 18, eff. July 1, 2002; Volume 30, Issue 19, eff. June 18, 2014.

12VAC30-90-41 Nursing facility reimbursement formula

A. Effective on and after July 1, 2002, all NFs subject to the prospective payment system shall be reimbursed under "The Resource Utilization Group-III (RUG-III) System as defined in Appendix IV (12VAC30-90-305 through 12VAC30-90-307)." RUG-III is a resident classification system that groups NF residents according to resource utilization. Case-mix indices (CMIs) are assigned to RUG-III groups and are used to adjust the NF's per diem rates to reflect the intensity of services required by a NF's resident mix. See 12VAC30-90-305 through 12VAC30-90-307 for details on the Resource Utilization Groups.

1. Any NF receiving Medicaid payments on or after October 1, 1990, shall satisfy all the requirements of § 1919(b) through (d) of the Social Security Act as they relate to provision of services, residents' rights and administration and other matters.

2. Direct and indirect group ceilings and rates.

a. Direct patient care operating cost peer groups shall be established for the Virginia portion of the Washington DC-MD-VA MSA, the Richmond-Petersburg MSA, and the rest of the state. Direct patient care operating costs shall be as defined in 12VAC30-90-271.

b. Indirect patient care operating cost peer groups shall be established for the Virginia portion of the Washington DC-MD-VA MSA, for the rest of the state for facilities with less than 61 licensed beds, and for the rest of the state for facilities with more than 60 licensed beds.

3. Each facility's average case-mix index shall be calculated based upon data reported by that nursing facility to the Centers for Medicare and Medicaid Services (CMS) Minimum Data Set (MDS) System. See 12VAC30-90-306 for the case-mix index calculations.

4. The normalized facility average Medicaid CMI shall be used to calculate the direct patient care operating cost prospective ceilings and direct patient care operating cost prospective rates for each semiannual period of a NFs subsequent fiscal year. See 12VAC30-90-306 D 2 for the calculation of the normalized facility average Medicaid CMI.

a. A NF's direct patient care operating cost prospective ceiling shall be the product of the NF's peer group direct patient care ceiling and the NF's normalized facility average Medicaid CMI. A NF's direct patient care operating cost prospective ceiling will be calculated semiannually.

b. A CMI rate adjustment for each semiannual period of a nursing facility's prospective fiscal year shall be applied by multiplying the nursing facility's normalized facility average Medicaid CMI applicable to each prospective semiannual period by the nursing facility's case-mix neutralized direct patient care operating cost base rate for the preceding cost reporting period (see 12VAC30-90-307).

c. See 12VAC30-90-307 for the applicability of case-mix indices.

5. Direct and indirect ceiling calculations.

a. Effective for services on and after July 1, 2006, the direct patient care operating ceiling shall be set at 117% of the respective peer group day-weighted median of the facilities' case-mix neutralized direct care operating costs per day. The calculation of the medians shall be based on cost reports from freestanding nursing homes for provider fiscal years ending in the most recent base year. The medians used to set the peer group direct patient care operating ceilings shall be revised and case-mix neutralized every two years using the most recent reliable calendar year cost settled cost reports for freestanding nursing facilities that have been completed as of September 1.

b. The indirect patient care operating ceiling shall be set at 107% of the respective peer group day-weighted median of the facility's specific indirect operating cost per day. The calculation of the peer group medians shall be based on cost reports from freestanding nursing homes for provider fiscal years ending in the most recent base year. The medians used to set the peer group indirect operating ceilings shall be revised every two years using the most recent reliable calendar year cost settled cost reports for freestanding nursing facilities that have been completed as of September 1.

6. Reimbursement for use of specialized treatment beds. Effective for services on and after July 1, 2005, nursing facilities shall be reimbursed an additional $10 per day for those recipients who require a specialized treatment bed due to their having at least one Stage IV pressure ulcer. Recipients must meet criteria as outlined in 12VAC30-60-350, and the additional reimbursement must be preauthorized as provided in 12VAC30-60-40. Nursing facilities shall not be eligible to receive this reimbursement for individuals whose services are reimbursed under the specialized care methodology. Beginning July 1, 2005, this additional reimbursement shall be subject to adjustment for inflation in accordance with 12VAC30-90-41 B, except that the adjustment shall be made at the beginning of each state fiscal year, using the inflation factor that applies to provider years beginning at that time. This additional payment shall not be subject to direct or indirect ceilings and shall not be adjusted at year-end settlement.

B. Adjustment of ceilings and costs for inflation. Effective for provider fiscal years starting on and after July 1, 2002, ceilings and rates shall be adjusted for inflation each year using the moving average of the percentage change of the Virginia-Specific Nursing Home Input Price Index, updated quarterly, published by Standard & Poor's DRI. For state fiscal year 2003, peer group ceilings and rates for indirect costs will not be adjusted for inflation.

1. For provider years beginning in each calendar year, the percentage used shall be the moving average for the second quarter of the year, taken from the table published for the fourth quarter of the previous year. For example, in setting prospective rates for all provider years beginning in January through December 2002, ceilings and costs would be inflated using the moving average for the second quarter of 2002, taken from the table published for the fourth quarter of 2001.

2. Provider specific costs shall be adjusted for inflation each year from the cost reporting period to the prospective rate period using the moving average as specified in subdivision 1 of this subsection. If the cost reporting period or the prospective rate period is less than 12 months long, a fraction of the moving average shall be used that is equal to the fraction of a year from the midpoint of the cost reporting period to the midpoint of the prospective rate period.

3. Ceilings shall be adjusted from the common point established in the most recent rebasing calculation. Base period costs shall be adjusted to this common point using moving averages from the DRI tables corresponding to the provider fiscal period, as specified in subdivision 1 of this subsection. Ceilings shall then be adjusted from the common point to the prospective rate period using the moving averages for each applicable second quarter, taken from the DRI table published for the fourth quarter of the year immediately preceding the calendar year in which the prospective rate years begin. Rebased ceilings shall be effective on July 1 of each rebasing year, so in their first application they shall be adjusted to the midpoint of the provider fiscal year then in progress or then beginning. Subsequently, they shall be adjusted each year from the common point established in rebasing to the midpoint of the appropriate provider fiscal year. For example, suppose the base year is made up of cost reports from years ending in calendar year 2000, the rebasing year is SFY2003, and the rebasing calculation establishes ceilings that are inflated to the common point of July 1, 2002. Providers with years in progress on July 1, 2002, would receive a ceiling effective July 1, 2002, that would be adjusted to the midpoint of the provider year then in progress. In some cases this would mean the ceiling would be reduced from the July 1, 2002, ceiling level. The following table shows the application of these provisions for different provider fiscal periods.

| Table I Application of Inflation to Different Provider Fiscal Periods | | | | | | | | --- | --- | --- | --- | --- | --- | --- | | | Provider FYE | Effective Date of New Ceiling | First PFYE After Rebasing Date | Inflation Time Span from Ceiling Date to Midpoint of First PFY | Second PFYE After Rebasing Date | Inflation Time Span from Ceiling Date to Midpoint of Second PFY | | | 3/31 | 7/1/02 | 3/31/03 | + 1/4 year | 3/31/04 | + 1-1/4 years | | | 6/30 | 7/1/02 | 6/30/03 | + 1/2 year | 6/30/04 | + 1-1/2 years | | | 9/30 | 7/1/02 | 9/30/02 | - 1/4 year | 9/30/03 | + 3/4 year | | | 12/31 | 7/1/02 | 12/31/02 | -0- | 12/31/03 | + 1 year |

The following table shows the DRI tables that would provide the moving averages for adjusting ceilings for different prospective rate years.

| Table II Source Tables for DRI Moving Average Values | | | | | | | | --- | --- | --- | --- | --- | --- | --- | | | Provider FYE | Effective Date of New Ceiling | First PFYE After Rebasing Date | Source DRI Table for First PFY Ceiling Inflation | Second PFYE After Rebasing Date | Source DRI Table for Second PFY Ceiling Inflation | | | 3/31 | 7/1/02 | 3/31/03 | Fourth Quarter 2001 | 3/31/04 | Fourth Quarter 2002 | | | 6/30 | 7/1/02 | 6/30/03 | Fourth Quarter 2001 | 6/30/04 | Fourth Quarter 2002 | | | 9/30 | 7/1/02 | 9/30/02 | Fourth Quarter 2000 | 9/30/03 | Fourth Quarter 2001 | | | 12/31 | 7/1/02 | 12/31/02 | Fourth Quarter 2000 | 12/31/03 | Fourth Quarter 2001 |

In this example, when ceilings are inflated for the second PFY after the rebasing date, the ceilings will be inflated from July 1, 2002, using moving averages from the DRI table specified for the second PFY. That is, the ceiling for years ending June 30, 2004, will be the June 30, 2002, base period ceiling, adjusted by 1/2 of the moving average for the second quarter of 2002, compounded with the moving average for the second quarter of 2003. Both these moving averages will be taken from the fourth quarter 2002 DRI table.

C. The RUG-III Nursing Home Payment System shall require comparison of the prospective operating cost rates to the prospective operating ceilings. The provider shall be reimbursed the lower of the prospective operating cost rate or prospective operating ceiling.

D. Nonoperating costs. Plant or capital, as appropriate, costs shall be reimbursed in accordance with Articles 1 (12VAC30-90-29), 2 (12VAC30-90-30 et seq.), and 3 (12VAC30-90-35 et seq.) of this subpart. Plant costs shall not include the component of cost related to making or producing a supply or service.

NATCEPs cost shall be reimbursed in accordance with 12VAC30-90-170.

E. The prospective rate for each NF shall be based upon operating cost and plant or capital cost components or charges, whichever is lower, plus NATCEPs costs. The disallowance of nonreimbursable operating costs in any current fiscal year shall be reflected in a subsequent year's prospective rate determination. Disallowances of nonreimbursable plant or capital, as appropriate, costs and NATCEPs costs shall be reflected in the year in which the nonreimbursable costs are included.

F. Effective July 1, 2001, for those NFs whose indirect operating cost rates are below the ceilings, an incentive plan shall be established whereby a NF shall be paid, on a sliding scale, up to 25% of the difference between its allowable indirect operating cost rates and the indirect peer group ceilings.

1. The following table presents four incentive examples:

| | Peer Group Ceilings | Allowable Cost Per Day | Difference | % of Ceiling | Sliding Scale | Scale % Difference | | --- | --- | --- | --- | --- | --- | --- | | | $30.00 | $27.00 | $3.00 | 10% | $0.30 | 10% | | | 30.00 | 22.50 | 7.50 | 25% | 1.88 | 25% | | | 30.00 | 20.00 | 10.00 | 33% | 2.50 | 25% | | | 30.00 | 30.00 | 0 | 0 | | |

2. Efficiency incentives shall be calculated only for the indirect patient care operating ceilings and costs. Effective July 1, 2001, a direct care efficiency incentive shall no longer be paid.

G. Quality of care requirement. A cost efficiency incentive shall not be paid for the number of days for which a facility is out of substantial compliance according to the Virginia Department of Health survey findings as based on federal regulations.

H. Sale of facility. In the event of the sale of a NF, the prospective base operating cost rates for the new owner's first fiscal period shall be the seller's prospective base operating cost rates before the sale.

I. Public notice. To comply with the requirements of § 1902(a)(28)(c) of the Social Security Act, DMAS shall make available to the public the data and methodology used in establishing Medicaid payment rates for nursing facilities. Copies may be obtained by request under the existing procedures of the Virginia Freedom of Information Act.

J. Effective July 1, 2005, the total per diem payment to each nursing home shall be increased by $3.00 per day. This increase in the total per diem payment shall cease effective July 1, 2006. Effective July 1, 2006, when cost data that include time periods before July 1, 2005, are used to set facility specific rates, a portion of the $3.00 per day amount identified in this subsection, based on the percentage of patient days in the provider's cost reporting period that fall before July 1, 2005, adjusted for appropriate inflation and multiplied times the provider's Medicaid utilization rate, shall be allocated to the facility specific direct and indirect cost per day prior to comparison to the peer group ceilings. For purposes of this subsection, $1.68 of the $3.00 shall be considered direct costs and $1.32 of the $3.00 shall be considered indirect costs.

K. Effective July 1, 2008, and ending after June 30, 2009, the operating rate for nursing facilities shall be reduced by 1.329%.

L. Effective July 1, 2009, through June 30, 2010, there will be no inflation adjustment for nursing facility operating rates and ceilings and specialized care operating rates and ceilings. Exempt from this are government-owned nursing facilities with Medicaid utilization of 85% or greater in provider fiscal year 2007.

M. Effective July 1, 2010, through June 30, 2012, there shall be no inflation adjustment for nursing facility and specialized care operating rates. Nursing facility and specialized care ceilings shall freeze at the same level as the ceilings for nursing facilities with provider fiscal year ends of June 30, 2010.

N. Effective July 1, 2010, through September 30, 2010, the operating rate for nursing facilities shall be reduced 3.0% below the rates otherwise calculated.

O. Effective July 1, 2012, through June 30, 2014, the inflation adjustment for nursing facility and specialized care operating rates shall be 2.2%. Nursing facility and specialized care ceilings in effect in SFY 2012 shall be increased 3.2% in SFY 2013 and 2.2% in SFY 2014.

P. The reimbursement methodology described in this section shall be utilized for dates of service through June 30, 2014. Effective July 1, 2014, nursing facilities shall be reimbursed the price-based methodology described in 12VAC30-90-44. The last cost report with a fiscal year end before June 30, 2014, shall be used to establish the operating per diem rates for payment for the remainder of state fiscal year 2014. The last cost report with a fiscal year end on or after June 30, 2014, shall be used to settle reimbursement for plant costs, NATCEPs, and criminal records check costs for periods in state fiscal year 2014. Reimbursement for these components shall be prorated based on the number of cost report months prior to July 1, 2014, as a percentage of total months in the cost report. Settlement for these components will be based on two months of run-out from the end of the provider's fiscal year. Claims for services paid after the cost report run-out period will not be settled.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 16, eff. July 1, 1996; amended, Virginia Register Volume 17, Issue 18, eff. July 1, 2001; Volume 18, Issue 18, eff. July 1, 2002; Volume 19, Issue 18, eff. July 1, 2003; Volume 21, Issue 15, eff. July 1, 2005; Volume 22, Issue 22, eff. August 9, 2006; Volume 23, Issue 20, eff. August 25, 2007; Volume 24, Issue 26, eff. October 15, 2008; Volume 26, Issue 12, eff. March 17, 2010; Volume 26, Issue 19, eff. July 1, 2010; Volume 27, Issue 19, eff. July 1, 2011; Volume 29, Issue 23, eff. August 14, 2013; Volume 32, Issue 9, eff. February 11, 2016.

12VAC30-90-42 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 12, Issue 16, eff. July 1, 1996; repealed, Virginia Register Volume 17, Issue 18, eff. July 1, 2001.

12VAC30-90-44 Nursing facility price-based reimbursement methodology

A. Effective July 1, 2014, DMAS shall convert nursing facility operating rates in 12VAC30-90-41 to a price-based methodology. The department shall calculate prospective operating rates for direct and indirect costs in the following manner:

1. The department shall calculate the cost per day in the base year for direct and indirect operating costs for each nursing facility. The department shall use existing definitions of direct and indirect costs.

2. The initial base year for calculating the cost per day shall be cost reports ending in calendar year 2011. The department shall rebase prices in fiscal year 2018 and every three years thereafter using the most recent, reliable calendar year cost-settled cost reports for freestanding nursing facilities that have been completed as of September 1. No adjustments will be made to the base year data for purposes of rate setting after that date.

3. Each nursing facility's direct cost per day shall be neutralized by dividing the direct cost per day by the raw Medicaid facility case-mix that corresponds to the base year by facility.

4. Costs per day shall be inflated to the midpoint of the fiscal year rate period using the moving average Virginia Nursing Home inflation index for the fourth quarter of each year (the midpoint of the fiscal year). Costs in the 2011 base year shall be inflated from the midpoint of the cost report year to the midpoint of fiscal year 2012 by prorating fiscal year 2012 inflation and annual inflation after that. Annual inflation adjustments shall be based on the last available report prior to the beginning of the fiscal year and corrected for any revisions to prior year inflation. Effective July 1, 2015, through June 30, 2016, the inflation adjustment for nursing facility operating rates shall be 0.0%.

5. Prices will be established for the peer groups described in this section using a combination of Medicare wage regions and Medicaid rural and bed size modifications based on similar costs.

6. The following definitions shall apply to direct peer groups. The Northern Virginia peer group shall be defined as localities in the Washington DC-MD-VA MSA as published by the Centers for Medicare and Medicaid Services (CMS) for skilled nursing facility rates. The Other MSAs peer group includes localities in any MSA defined by CMS other than the Northern Virginia MSA and non-MSA designations. The Rural peer groups are non-MSA areas of the state divided into Northern Rural and Southern Rural peer groups based on drawing a line between the following points on the Commonwealth of Virginia map with the coordinates: 37.4203914 Latitude, 82.0201219 Longitude and 37.1223664 Latitude, 76.3457773 Longitude. Direct peer groups are:

a. Northern Virginia,

b. Other MSAs,

c. Northern Rural, and

d. Southern Rural.

7. The following definitions shall apply to indirect peer groups. The indirect peer group for Northern Virginia is the same as the direct peer group for Northern Virginia. Rest of State peer groups shall be defined as any localities other than localities in the Northern Virginia peer group for nursing facilities with greater than 60 beds or 60 beds or less. Rest of State - Greater than 60 Beds shall be further subdivided into Other MSAs, Northern Rural and Southern Rural peer groups using the locality definitions for direct peer groups. Indirect peer groups are:

a. Northern Virginia MSA,

b. Rest of State - Greater than 60 Beds,

c. Other MSAs,

d. Northern Rural, and

e. Southern Rural.

Rest of State - 60 Beds or Less.

8. Any changes to peer group assignment based on changes in bed size or MSA will be implemented for reimbursement purposes the July 1 following the effective date of the change. For rebasings effective on or after July 1, 2020, the department shall move nursing facilities located in the former Danville Metropolitan Statistical Area to the Other MSAs peer group.

9. The direct and indirect price for each peer group shall be based on the following adjustment factors:

a. Direct adjustment factor - 105.000% of the peer group day-weighted median neutralized and inflated cost per day for freestanding nursing facilities. Effective July 1, 2017, the direct adjustment factor shall be 106.8% of the peer group day-weighted median neutralized and inflated cost per day for freestanding nursing facilities.

b. Indirect adjustment factor - 100.735% of the peer group day-weighted median inflated cost per day for freestanding nursing facilities. Effective July 1, 2017, the indirect adjustment factor shall be 101.3% of the peer group day-weighted median inflated cost per day for freestanding nursing facilities.

10. Facilities with costs projected to the rate year below 95% of the price shall have an adjusted price equal to the price minus the difference between the facility's cost and 95% of the unadjusted price. Adjusted prices will be established at each rebasing. New facilities after the base year shall not have an adjusted price until the next rebasing.

11. Special circumstances.

a. Effective July 1, 2017, the department shall increase the direct and indirect operating rates under the nursing facility price based reimbursement methodology by 15% for nursing facilities where at least 80% of the resident population has one or more of the following diagnoses: quadriplegia, traumatic brain injury, multiple sclerosis, paraplegia, or cerebral palsy. In addition, a qualifying facility must have at least 90% Medicaid utilization and a nursing facility case-mix index of 1.15 or higher in fiscal year 2014.

b. Effective July 1, 2017, through June 30, 2020, nursing facilities located in the former Danville Metropolitan Statistical Area shall be paid the operating rates calculated for the Other MSAs peer group.

12. Individual claim payment for direct costs shall be based on each resident's Resource Utilization Group (RUG) during the service period times the facility direct price.

13. Resource Utilization Group (RUG) is a resident classification system that groups nursing facility residents according to resource utilization and assigns weights related to the resource utilization for each classification. The department shall use RUGs to determine facility case-mix for cost neutralization as defined in 12VAC30-90-306 in determining the direct costs used in setting the price and for adjusting the claim payments for residents.

a. The department shall neutralize direct costs per day in the base year using the most current RUG grouper applicable to the base year.

b. The department shall utilize RUG-III, version 34 groups and weights in fiscal years 2015 through 2017 for claim payments.

c. Beginning in fiscal year 2018, the department shall implement RUG-IV, version 48 Medicaid groups and weights for claim payments.

d. RUG-IV, version 48 weights used for claim payments will be normalized to RUG-III, version 34 weights as long as base year costs are neutralized by the RUG-III 34 group. In that the weights are not the same under RUG-IV as under RUG-III, normalization will ensure that total direct operating payments using the RUG-IV 48 weights will be the same as total direct operating payments using the RUG-III 34 grouper.

B. Transition. The department shall transition to the price-based methodology over a period of four years, blending the adjusted price-based rate with the facility-specific case-mix neutral cost-based rate calculated according to 12VAC30-90-41 as if ceilings had been rebased for fiscal year 2015. The cost-based rates are calculated using the 2011 base year data, inflated to 2015 using the inflation methodology in 12VAC30-90-41 and adjusted to state fiscal year 2015. In subsequent years of the transition, the cost-based rates shall be increased by inflation described in this section.

1. Based on a four-year transition, the rate will be based on the following blend:

a. Fiscal year 2015 - 25% of the adjusted price-based rate and 75% of the cost-based rate.

b. Fiscal year 2016 - 50% of the adjusted price-based rate and 50% of the cost-based rate.

c. Fiscal year 2017 - 75% of the adjusted price-based rate and 25% of the cost-based rate.

d. Fiscal year 2018 - 100% of the adjusted price-based (fully implemented).

2. During the first transition year for the period July 1, 2014, through October 31, 2014, DMAS shall case-mix adjust each facility's direct cost component of the rates using the average facility case-mix from the two most recent finalized quarters (September and December 2013) instead of adjusting this component claim by claim.

3. Cost-based rates to be used in the transition for facilities without cost data in the base year but placed in service prior to July 1, 2013, shall be determined based on the most recently settled cost data. If there is no settled cost report at the beginning of a fiscal year, then 100% of the price-based rate shall be used for that fiscal year. Facilities placed in service after June 30, 2013, shall be paid 100% of the price-based rate.

4. Effective July 1, 2015, nursing facilities whose licensed bed capacity decreased by at least 30 beds after 2011 and whose occupancy increased from less than 70% in 2011 to more than 80% in 2013 shall be reimbursed the price-based operating rate rather than the transition operating rate.

C. Prospective capital rates shall be calculated in the following manner:

1. Fair rental value (FRV) per diem rates for the fiscal year shall be calculated for all freestanding nursing facilities based on the prior calendar year information aged to the fiscal year and using RS Means factors and rental rates corresponding to the fiscal year as prescribed in 12VAC30-90-36. There will be no separate calculation for beds subject to or not subject to transition.

2. FRV per diem rates for new nursing facilities or major renovations that qualify for mid-year rate adjustments shall be calculated as prescribed in 12VAC30-90-28.

a. These FRV changes shall also apply to specialized care facilities.

b. The capital per diem rate for hospital-based nursing facilities shall be the last settled capital per diem.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Previously reserved; derived from Virginia Register Volume 32, Issue 9, eff. February 11, 2016; amended, Virginia Register Volume 33, Issue 4, eff. December 1, 2016; Volume 34, Issue 11, eff. February 21, 2018; Volume 37, Issue 14, eff. April 15, 2021.

12VAC30-90-45 Supplemental payments for state-owned nursing facilities

A. Effective July 1, 2018, DMAS shall make supplemental payments to state-owned nursing facilities owned by a Type One hospital. Quarterly supplemental payments for each facility shall be calculated in the manner described in this section.

B. Reimbursement methodology. The supplemental payment shall equal inpatient nursing facility claim payments times the upper payment limit (UPL) gap percentage.

1. The annual UPL gap percentage is the percentage calculated where the numerator is the difference for each nursing facility between a reasonable estimate of the amount that would be paid under Medicare payment principles for nursing facility services provided to Medicaid patients calculated in accordance with 42 CFR 447.272 and what Medicaid paid for such services, and the denominator is Medicaid payments to each nursing facility for nursing facility services provided to Medicaid patients in the same year used in the numerator.

2. The UPL gap percentage will be calculated annually for each nursing facility using data for the most recent year for which comprehensive annual data are available and inflated to the state fiscal year for which payments are to be made.

3. Maximum aggregate payments to all qualifying nursing facilities shall not exceed the available UPL. If nursing facility payments for state nursing facilities would exceed the UPL, the numerator in the calculation of the UPL gap percentage shall be reduced proportionately.

C. Quarterly payments. After the close of each quarter, beginning with the July 1, 2018, to September 30, 2018, quarter, each qualifying nursing facility shall receive supplemental payments for the nursing facility services paid during the prior quarter. The supplemental payments for each qualifying nursing facility shall be calculated by multiplying Medicaid nursing facility payments paid in that quarter by the annual UPL gap percentage.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Previously reserved; amended, Virginia Register Volume 36, Issue 1, eff. October 2, 2019.

12VAC30-90-46 [Reserved]. (Reserved)

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Historical Notes:Previously reserved.

12VAC30-90-47 [Reserved]. (Reserved)

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Historical Notes:Previously reserved.

12VAC30-90-48 [Reserved]. (Reserved)

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Historical Notes:Previously reserved.

12VAC30-90-49 [Reserved]. (Reserved)

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Historical Notes:Previously reserved.

Article 5 Allowable Cost Identification

12VAC30-90-50 Allowable costs

Article 5 Allowable Cost Identification

A. Costs which are included in rate determination procedures and final settlement shall be only those allowable, reasonable costs which are acceptable under the Medicare principles of reimbursement, except as specifically modified in the Plan and as may be subject to individual or ceiling cost limitations and which are classified in accordance with the DMAS uniform chart of accounts (see Appendix I (12VAC30-90-270 through 12VAC30-90-276) of Part III of this chapter).

B. Certification. The cost of meeting all certification standards for NF requirements as required by the appropriate state agencies, by state laws, or by federal legislation or regulations.

C. Operating costs.

1. Direct patient care operating costs shall be defined in 12VAC30-90-271.

2. Allowable direct patient care operating costs shall exclude (i) personal physician fees, and (ii) pharmacy services and prescribed legend and nonlegend drugs provided by nursing facilities which operate licensed in-house pharmacies. These services shall be billed directly to DMAS through separate provider agreements and DMAS shall pay directly in accordance with 12VAC30-80-10 et seq.

3. Indirect patient care operating costs include all other operating costs, not identified as direct patient care operating costs and NATCEPs costs in Appendix I (12VAC30-90-270 through 12VAC30-90-276) of Part III of this chapter, which are allowable under the Medicare principles of reimbursement, except as specifically modified herein and as may be subject to individual cost or ceiling limitations.

D. Allowances/goodwill. Bad debts, goodwill, charity, courtesy, and all other contractual allowances shall not be recognized as allowable costs.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia and Item 319 (II) of Chapter 1073 of the 2000 Acts of Assembly.
• Historical Notes: Derived from VR460-03-4.1940:1 Article 3, eff. July 1, 1994; amended, Virginia Register Volume 12, Issue 16, eff. July 1, 1996; Volume 17, Issue 18, eff. July 1, 2001.

12VAC30-90-51 Purchases/related organizations

A. Costs applicable to services, facilities, and supplies furnished to the provider by organizations related to the provider by common ownership or control shall be included in the allowable cost of the provider at the cost to the related organization, provided that such costs do not exceed the price of comparable services, facilities or supplies. Purchases of existing NFs by related parties shall be governed by the provisions of 12VAC30-90-34 B 1.

Allowable cost applicable to management services furnished to the provider by organizations related to the provider by common ownership or control shall be lesser of the cost to the related organization or the per patient day ceiling limitation established for management services cost. (See 12VAC30-90-290.)

B. "Related to the provider" shall mean that the provider is related by reasons of common ownership or control by the organization furnishing the services, facilities, or supplies.

C. Common ownership exists when an individual or individuals or entity or entities possess significant ownership or equity in the parties to the transaction. Control exists where an individual or individuals or entity or entities have the power, directly or indirectly, significantly to influence or direct the actions or policies of the parties to the transaction. Significant ownership or control shall be deemed to exist where an individual is a "person with an ownership or control interest" within the meaning of 42 CFR 455.101. If the parties to the transaction are members of an immediate family, as defined below, the transaction shall be presumed to be between related parties if the ownership or control by immediate family members, when aggregated together, meets the definitions of "common ownership" or "control," as set forth above. Immediate family shall be defined to include, but not be limited to, the following: (i) husband and wife; (ii) natural parent; child and sibling; (iii) adopted child and adoptive parent; (iv) step-parent, step-child, step-sister, and step-brother; (v) father-in-law, mother-in-law, sister-in-law, brother-in-law, son-in-law and daughter-in-law; and (vi) grandparent and grandchild.

D. Exception to the related organization principle.

1. Effective with cost reports having fiscal years beginning on or after July 1, 1986, an exception to the related organization principle shall be allowed. Under this exception, charges by a related organization to a provider for goods or services shall be allowable cost to the provider if all four of the conditions set out in subdivision 2 of this subsection are met.

2. The exception applies if the provider demonstrates by convincing evidence to the satisfaction of DMAS that the following criteria have been met:

a. The supplying organization is a bona fide separate organization. This means that the supplier is a separate sole proprietorship, partnership, joint venture, association or corporation and not merely an operating division of the provider organization.

b. A substantial part of the supplying organization's business activity of the type carried on with the provider is transacted with other organizations not related to the provider and the supplier by common ownership or control and there is an open, competitive market for the type of goods or services furnished by the organization. In determining whether the activities are of similar type, it is important to also consider the scope of the activity.

For example, a full service management contract would not be considered the same type of business activity as a minor data processing contract. The requirement that there be an open, competitive market is merely intended to assure that the item supplied has a readily discernible price that is established through arm's-length bargaining by well informed buyers and sellers.

c. The goods or services shall be those which commonly are obtained by institutions such as the provider from other organizations and are not a basic element of patient care ordinarily furnished directly to patients by such institutions. This requirement means that institutions such as the provider typically obtain the good or services from outside sources rather than producing the item internally.

d. The charge to the provider is in line with the charge for such services, or supplies in the open market and no more than the charge made under comparable circumstances to others by the organization for such goods or services. The phrase "open market" takes the same meaning as "open, competitive market" in subdivision 2 b of this subsection.

3. Where all of the conditions of this exception are met, the charges by the supplier to the provider for such goods or services shall be allowable as costs.

4. This exception does not apply to the purchase, lease or construction of assets such as property, buildings, fixed equipment or major movable equipment. The terms "goods and services" may not be interpreted or construed to mean capital costs associated with such purchases, leases, or construction.

E. Three competitive bids shall not be required for the building and fixed equipment components of a construction project outlined in 12VAC30-90-31. Reimbursement shall be in accordance with subsection A of this section with the limitations stated in 12VAC30-90-31 B.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia and Item 319 (II) of Chapter 1073 of the 2000 Acts of Assembly.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 16, eff. July 1, 1996; amended, Virginia Register Volume 17, Issue 18, eff. July 1, 2001.

12VAC30-90-52 Administrator/owner compensation

A. Administrators' compensation, whether administrators are owners or nonowners, shall be based on a schedule adopted by DMAS and varied according to facility bed size. The compensation schedule shall be adjusted annually to reflect cost-of-living increases and shall be published and distributed to providers annually. The administrator's compensation schedule covers only the position of administrator and assistants and does not include the compensation of owners employed in capacities other than the nursing facility administrator (see 12VAC30-90-290, Cost reimbursement limitations).

B. Administrator compensation shall mean remuneration paid regardless of the form in which it is paid. This includes, but shall not be limited to, salaries, professional fees, insurance premiums (if the benefits accrue to the employee/owner or his beneficiary), director fees, personal use of automobiles, consultant fees, management fees, travel allowances, relocation expenses in excess of IRS guidelines, meal allowances, bonuses, pension plan costs, and deferred compensation plans. Management fees, consulting fees, and other services performed by owners shall be included in the total compensation if they are performing administrative duties regardless of how such services may be classified by the provider.

C. Compensation for all administrators (owner and nonowner) shall be based upon a 40-hour week to determine reasonableness of compensation.

D. Owner/administrator employment documentation.

1. Owners who perform services for a nursing facility as an administrator and also perform additional duties must maintain adequate documentation to show that the additional duties were performed beyond the normal 40-hour week as an administrator. The additional duties must be necessary for the operation of the nursing facility and related to patient care.

2. Services provided by owners, whether in employee capacity, through management contracts, or through home office relationships shall be compared to the cost and services provided in arm's-length transactions.

3. Compensation for such services shall be adjusted where such compensation exceeds that paid in such arm's-length transactions or where there is a duplication of duties normally rendered by an administrator. No reimbursement shall be allowed for compensation where owner services cannot be documented and audited.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 16, eff. July 1, 1996; amended, Virginia Register Volume 14, Issue 22, eff. August 19, 1998.

12VAC30-90-53 Depreciation

The allowance for depreciation shall be restricted to the straight line method with a useful life in compliance with AHA guidelines. If the item is not included in the AHA guidelines, reasonableness shall be applied to determine useful life.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 16, eff. July 1, 1996.

12VAC30-90-54 Rent/Leases

Rent or lease expenses shall be limited by the provisions of 12VAC30-90-280.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 16, eff. July 1, 1996.

12VAC30-90-55 Provider payments

A. Limitations and effective for dates of service beginning July 1, 2001, through June 30, 2014:

1. Payments to providers, shall not exceed charges for covered services except for (i) public providers furnishing services free of charge or at a nominal charge (ii) a nonpublic provider whose charges are 60% or less of the allowable reimbursement represented by the charges and that demonstrates its charges are less than allowable reimbursement because its customary practice is to charge patients based on their ability to pay. Nominal charge shall be defined as total charges that are 60% or less of the allowable reimbursement of services represented by these charges. Providers qualifying in this section shall receive allowable reimbursement as determined in this Plan.

2. Allowable reimbursement in excess of charges may be carried forward for payment in the two succeeding cost reporting periods. A new provider may carry forward unreimbursed allowable reimbursement in the five succeeding cost reporting periods.

3. Providers may be reimbursed the carry forward to a succeeding cost reporting period (i) if total charges for the services provided in that subsequent period exceed the total allowable reimbursement in that period (ii) to the extent that the accumulation of the carry forward and the allowable reimbursement in that subsequent period do not exceed the providers' direct and indirect care operating ceilings plus allowable plant cost.

B. Payment for service shall be based upon the rate in effect when the service was rendered.

C. For cost reports filed on or after August 1, 1992, and used for cost reimbursement or rate setting based on cost:

1. An interim settlement shall be made by DMAS within 180 days after receipt and review of the cost report. The word "review," for purposes of interim settlement, shall include verification that all financial and other data specifically requested by DMAS is submitted with the cost report. Review shall also mean examination of the cost report and other required submission for obvious errors, inconsistency, inclusion of past disallowed costs, unresolved prior year cost adjustments and a complete signed cost report that conforms to the current DMAS requirements herein.

2. An interim settlement shall not be made when one of the following conditions exists:

a. Cost report filed by a terminated provider;

b. Insolvency of the provider at the time the cost report is submitted;

c. Lack of a valid provider agreement and decertification;

d. Moneys owed to DMAS;

e. Errors or inconsistencies in the cost report; or

f. Incomplete/nonacceptable cost report.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 16, eff. July 1, 1996; amended, Virginia Register Volume 17, Issue 18, eff. July 1, 2001; Volume 32, Issue 9, eff. February 11, 2016.

12VAC30-90-56 Legal fees/accounting

A. Costs claimed for legal/accounting fees shall be limited to reasonable and customary fees for specific services rendered. Such costs must be related to patient care as defined by Medicare principles of reimbursement and subject to applicable regulations herein. Documentation for legal costs must be available at the time of audit.

B. Retainer fees shall be considered an allowable cost up to the limits established in 12VAC30-90-290. C. As mandated by the Omnibus Budget Reconciliation Act of 1990, effective November 5, 1990, reimbursement of legal expenses for frivolous litigation shall be denied if the action is initiated on or after November 5, 1990. Frivolous litigation is any action initiated by the nursing facility that is dismissed on the basis that no reasonable legal ground existed for the institution of such action.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 16, eff. July 1, 1996.

12VAC30-90-57 Documentation

Adequate documentation supporting cost claims must be provided at the time of interim settlement, cost settlement, audit, and final settlement.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 16, eff. July 1, 1996.

12VAC30-90-58 Fraud and abuse

Previously disallowed costs which are under appeal and affect more than one cost reporting period shall be disclosed in subsequent cost reports if the provider wishes to reserve appeal rights for such subsequent cost reports. The reimbursement effect of such appealed costs shall be computed by the provider and submitted to DMAS with the cost report. Where such disclosure is not made to DMAS, the inclusion of previously disallowed costs may be referred to the Medicaid Fraud Control Unit of the Office of the Attorney General.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 16, eff. July 1, 1996.

12VAC30-90-59 [Reserved]. (Reserved)

Article 6 New Nursing Facilities

12VAC30-90-60 Interim rate

Article 6 New Nursing Facilities

A. A new facility shall be defined as follows:

1. A facility that is newly enrolled and new construction has taken place through the COPN process; or

2. A facility that is newly enrolled that was previously denied payments for new admissions and was subsequently terminated from the program.

B. The following provisions sunset effective July 1, 2015, when applied to indirect reimbursement but remain in effect when applied to capital reimbursement.

1. Upon a showing of good cause, and approval of DMAS, an existing NF that expands its bed capacity by 50% or more shall have the option of retaining its prospective rate or being treated as a new NF.

2. A replacement facility or one that has changed location may not be considered a new facility if it serves the same inpatient population. An exception may be granted by DMAS if the provider can demonstrate that the occupancy substantially changed as a result of the facility being replaced or changing location. A decline in the replacement facility's total occupancy of 20 percentage points, in the replacement facility's first cost reporting period, shall be considered to indicate a substantial change when compared to the lower of the old facility's previous two prior cost reporting periods. The replacement facility shall receive the previous operator's operating rates if it does not qualify to be considered a new facility.

3. A change in either ownership or adverse financial conditions (e.g., bankruptcy), or both, of a provider does not change a nursing facility's status to be considered a new facility.

4. Effective July 1, 2001, for all new NFs the required occupancy percentage for indirect and capital costs shall be waived for establishing the first cost reporting period interim rate. The required occupancy percentage for dates of service on or before June 30, 2013, shall be 90%, and for dates of service on or after July 1, 2013, shall be 88%. This first cost reporting period shall not exceed 13 months from the date of the NF's certification.

5. The required occupancy percentage for indirect and capital costs shall be applied to the first and subsequent cost reporting periods' actual indirect and capital costs for establishing such NFs second and future cost reporting periods' prospective reimbursement rates. The required occupancy percentage shall be considered as having been satisfied if the new NF achieved the required occupancy percentage at any point in time during the first cost reporting period.

a. The department may grant an exception to the minimum occupancy requirement for reimbursement purposes for beds taken out of service for the purpose of renovation. In this case, the occupancy requirement shall be calculated as the required occupancy percentage of available bed days for the period of the exception plus the required occupancy percentage of licensed bed days for the remainder of the cost report year.

b. The provider shall notify DMAS and the Virginia Department of Health (VDH), Division of Long Term Care Services, Office of Licensure and Certification in advance and present a renovation plan including a reasonable timetable for when the beds will be placed back into service.

c. The provider shall keep the appropriate documentation of available beds and days during the renovation period, which will provide the evidence of the beds and days taken out of service for renovation purposes. This supporting documentation, along with a copy of the provider's notification letter to the VDH Division of Long Term Care Services, Office of Licensure and Certification shall be submitted with the filing of the provider's cost report, as applicable. The provider's notification letter shall account for the number of beds not in use for the defined period of time.

6. A new NF's interim rate for the first cost reporting period shall be determined based upon the lower of its anticipated allowable cost determined from a detailed budget (or pro forma cost report) prepared by the provider and accepted by DMAS, or the appropriate operating ceilings or charges.

7. Effective July 1, 2001, on the first day of its second cost reporting period, a new nursing facility's interim plant or capital, as appropriate, rate shall be converted to a per diem amount by dividing its allowable plant or capital costs for its first cost reporting period by the required occupancy percentage of the potential number of patient days for all licensed beds during the first cost reporting period.

8. During its first semiannual period of operation, a newly constructed or newly enrolled NF shall have an assigned CMI based upon its peer group's normalized average Medicaid CMI for direct patient care. An expanded NF receiving new NF treatment shall receive the CMI calculated for its last semiannual period prior to obtaining new NF status.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 set seq.
• Historical Notes: Derived from VR460-03-4.1940:1 Article 4 eff. July 1, 1994; amended, Virginia Register Volume 12, Issue 16, eff. July 1, 1996; Volume 17, Issue 18, eff. July 1, 2001; Volume 18, Issue 18, eff. July 1, 2002; Volume 27, Issue 15, eff. April 27, 2011; Volume 30, Issue 19, eff. June 18, 2014; Volume 32, Issue 9, eff. February 11, 2016.

12VAC30-90-65 Final rate and effective for dates of services beginning July 1, 2001, through June 30, 2014

A. This section shall apply to dates of services beginning July 1, 2001, through June 30, 2014.

B. DMAS shall reimburse the lower of the appropriate operating ceilings, charges or actual allowable cost for a new NF's first cost reporting period of operation, subject to the procedures outlined in subdivisions 4, 5, and 6 of 12VAC30-90-60.

C. Upon determination of the actual allowable operating cost for direct patient care and indirect patient care the per diem amounts shall be used to determine if the provider is below the peer group ceiling used to set its interim rate. If indirect costs are below the ceiling, an efficiency incentive shall be paid at settlement of the first year cost report.

D. This incentive will allow a NF to be paid up to 25% of the difference between its actual allowable indirect operating cost and the peer group ceiling used to set the interim rate. (Refer to 12VAC30-90-41 F.)

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 16, eff. July 1, 1996; amended, Virginia Register Volume 17, Issue 18, eff. July 1, 2001; Volume 32, Issue 9, eff. February 11, 2016.

Article 7 Cost Reports

12VAC30-90-70 Cost report submission

Article 7 Cost Reports

A. Cost reports are due not later than 150 days after the provider's fiscal year end. If a complete cost report is not received within 150 days after the end of the provider's fiscal year, it is considered delinquent. The cost report shall be deemed complete for the purpose of cost settlement when DMAS has received all of the following (note that if the audited financial statements required by subdivisions 3 a and 7 b of this subsection are received not later than 120 days after the provider's fiscal year end and all other items listed are received not later than 90 days after the provider's fiscal year end, the cost report shall be considered to have been filed at 90 days):

1. Completed cost reporting forms provided by DMAS, with signed certifications;

2. The provider's trial balance showing adjusting journal entries;

3. a. The provider's audited financial statements including, but not limited to, a balance sheet, a statement of income and expenses, a statement of retained earnings (or fund balance), a statement of cash flows, the auditor's report in which he expresses his opinion or, if circumstances require, disclaims an opinion based on generally accepted auditing standards, footnotes to the financial statements, and the management report. Multi-facility providers shall be governed by subdivision 7 of this subsection;

b. Schedule of restricted cash funds that identify the purpose of each fund and the amount;

c. Schedule of investments by type (stock, bond, etc.), amount, and current market value;

4. Schedules that reconcile financial statements and trial balance to expenses claimed in the cost report;

5. Depreciation schedule;

6. Schedule of assets as defined in 12VAC30-90-38;

7. Nursing facilities that are part of a chain organization must also file:

a. Home office cost report;

b. Audited consolidated financial statements of the chain organization including the auditor's report in which he expresses his opinion or, if circumstances require, disclaims an opinion based on generally accepted auditing standards, the management report and footnotes to the financial statements;

c. The nursing facility's financial statements including, but not limited to, a balance sheet, a statement of income and expenses, a statement of retained earnings (or fund balance), and a statement of cash flows;

d. Schedule of restricted cash funds that identify the purpose of each fund and the amount;

e. Schedule of investments by type (stock, bond, etc.), amount, and current market value; and

8. Such other analytical information or supporting documentation that may be required by DMAS.

B. When cost reports are delinquent, the provider's interim rate shall be reduced to zero. For example, for a September 30 fiscal year end, payments will be reduced starting with the payment on and after March 1.

C. After the overdue cost report is received, desk reviewed, and a new prospective rate established, the amounts withheld shall be computed and paid. If the provider fails to submit a complete cost report within 180 days after the fiscal year end, a penalty in the amount of 10% of the balance withheld shall be forfeited to DMAS.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-03-4.1940:1 Article 5, eff. July 1, 1994; amended, Virginia Register Volume 12, Issue 16, eff. July 1, 1996; Volume 14, Issue 1, eff. December 1, 1997; Volume 17, Issue 18, eff. July 1, 2001; Volume 32, Issue 6, eff. December 31, 2015.

12VAC30-90-75 Reporting form; accounting method; cost report extensions; fiscal year changes

A. All cost reports shall be submitted on uniform reporting forms provided by the DMAS, or by Medicare if applicable. Such cost reports, subsequent to the initial cost report period, shall cover a 12-month period. Any exceptions must be approved by the DMAS.

B. The accrual method of accounting and cost reporting is mandated for all providers.

C. Extension for submission of a cost report may be granted if the provider can document extraordinary circumstances beyond its control. Extraordinary circumstances do not include:

1. Absence or changes of chief finance officer, controller or bookkeeper;

2. Financial statements not completed;

3. Office or building renovations;

4. Home office cost report not completed;

5. Change of stock ownership;

6. Change of intermediary;

7. Conversion to computer; or

8. Use of reimbursement specialist.

D. All fiscal year end changes must be approved 90 days prior to the beginning of a new fiscal year.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 16, eff. July 1, 1996.

Article 8 Prospective Rates

12VAC30-90-80 Time frames

Article 8 Prospective Rates

A. For cost reports filed on or after August 1, 1992, a prospective rate shall be determined by DMAS within 180 days of the receipt of a complete cost report. (See 12VAC30-90-70 A.) Rate adjustments shall be made retroactive to the first day of the provider's new cost reporting year. Where a field audit is necessary to set a prospective rate, DMAS shall have an additional 120 days to determine any appropriate adjustments to the prospective rate as a result of such field audit. This time period shall be extended if delays are attributed to the provider.

B. Subsequent to establishing the prospective rate DMAS shall conclude the desk audit of a providers' cost report and determine if further field audit activity is necessary. DMAS will seek repayment or make retroactive settlements when audit adjustments are made to costs claimed for reimbursement.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia and Item 319 (II) of Chapter 1073 of the 2000 Acts of Assembly.
• Historical Notes: Derived from VR460-03-4.1940:1 Article 6, eff. August 1, 1993; amended, Virginia Register Volume 12, Issue 16, eff. July 1, 1996; Volume 17, Issue 18, eff. July 1, 2001.

Article 9 Retrospective Rates

12VAC30-90-90 Retrospective rates

Article 9 Retrospective Rates

The retrospective method of reimbursement shall be used for mental health/mental retardation facilities.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-03-4.1940:1 § 2.26, eff. October 1, 1990; amended, Virginia Register Volume 12, Issue 16, eff. July 1, 1996.

12VAC30-90-100 [Reserved]. (Reserved)

Article 10 Record Retention

12VAC30-90-110 Record retention

Article 10 Record Retention

A. Time frames. All of the NF's accounting and related records, including the general ledger, books of original entry, and statistical data must be maintained for a minimum of five years, or until all affected cost reports are final settled.

Certain information must be maintained for the duration of the provider's participation in the Medicaid program and until such time as all cost reports are settled. Examples of such information are set forth in subsection B of this section.

B. Types of records to be maintained. Information which must be maintained for the duration of the provider's participation in the Medicaid program includes, but is not limited to:

1. Real and tangible property records, including leases and the underlying cost of ownership;

2. Itemized depreciation schedules; and

3. Mortgage documents, loan agreements, and amortization schedules;

4. Copies of all cost reports filed with DMAS together with supporting financial statements.

C. Record availability. The records must be available for audits by DMAS staff. Where such records are not available, costs shall be disallowed.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia and Item 319 (II) of Chapter 1073 of the 2000 Acts of Assembly.
• Historical Notes: Derived from VR460-03-4.1940:1 Article 8, eff. October 1, 1990; amended, Virginia Register Volume 12, Issue 16, eff. July 1, 1996; Volume 17, Issue 18, eff. July 1, 2001.

Article 11 Audits

12VAC30-90-120 Audit overview; scope of audit

Article 11 Audits

A. Desk audits shall be performed to verify the completeness and accuracy of the cost report, and reasonableness of costs claimed for reimbursement. Field audits, as determined necessary by DMAS, shall be performed on the records of each participating provider to determine that costs included for reimbursement were accurately determined and reasonable, and do not exceed the ceilings or other reimbursement limitations established by DMAS.

B. The scope of the audit includes, but shall not be limited to: trial balance verification, analysis of fixed assets, schedule of assets, indebtedness, selected revenues, leases and the underlying cost of ownership, rentals and other contractual obligations, and costs to related organizations. The audit scope may also include various other analyses and studies relating to issues and questions unique to the NF and identified by DMAS. Census and related statistics, patient trust funds, and billing procedures are also subject to audit.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia and Item 319 (II) of Chapter 1073 of the 2000 Acts of Assembly.
• Historical Notes: Derived from VR460-03-4.1940:1 Article 9, eff. October 1, 1990; amended, Virginia Register Volume 12, Issue 16, eff. July 1, 1996; Volume 17, Issue 18, eff. July 1, 2001.

12VAC30-90-121 Field audit requirements

Field audits shall be required as follows:

1. For the first cost report on all new NF's.

2. For the first cost report in which costs for bed additions or other expansions are included.

3. When a NF is sold, purchased, or leased.

4. As determined by DMAS desk audit.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 16, eff. July 1, 1996.

12VAC30-90-122 Provider notification

The provider shall be notified in writing of all adjustments to be made to a cost report resulting from desk or field audit with stated reasons and references to the appropriate principles of reimbursement or other appropriate regulatory cites.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 16, eff. July 1, 1996.

12VAC30-90-123 Field audit exit conference

A. The provider shall be offered an exit conference to be executed within 15 days following completion of the on-site audit activities, unless other time frames are mutually agreed to by DMAS and the provider. Where two or more providers are part of a chain organization or under common ownership, DMAS shall have up to 90 days after completion of all related on-site audit activities to offer an exit conference for all such NFs. The exit conference shall be conducted at the site of the audit or at a location mutually agreeable to DMAS and the provider.

B. The purpose of the exit conference shall be to enable the DMAS auditor to discuss such matters as the auditor deems necessary, to review the proposed field audit adjustments, and to present supportive references. The provider will be given an opportunity during the exit conference to present additional documentation and agreement or disagreement with the audit adjustments.

C. All remaining adjustments, including those for which additional documentation is insufficient or not accepted by DMAS, shall be applied to the applicable cost report or reports regardless of the provider's approval or disapproval.

D. The provider shall sign an exit conference form that acknowledges the review of proposed adjustments.

E. After the exit conference DMAS shall perform a review of all remaining field audit adjustments. Within a reasonable time and after all documents have been submitted by the provider, DMAS shall transmit in writing to the provider a final field audit adjustment report (FAAR), if revised, which will include all remaining adjustments not resolved during the exit conference. The provider shall have 15 days from the date of the letter which transmits the FAAR, to submit any additional documentation which may affect adjustments in the FAAR.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia and Item 319 (II) of Chapter 1073 of the 2000 Acts of Assembly.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 16, eff. July 1, 1996; amended, Virginia Register Volume 17, Issue 18, eff. July 1, 2001.

12VAC30-90-124 Audit delay

In the event the provider delays or refuses to permit an audit to occur or to continue or otherwise interferes with the audit process, payments to the provider shall be reduced as stated in 12VAC30-90-70 B.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 16, eff. July 1, 1996.

12VAC30-90-125 Field audit time frames

A. If a field audit is necessary after receipt of a complete cost report, such audit shall be initiated within three years following the date of the last notification of program reimbursement and the on site activities, including exit conferences, shall be concluded within 180 days from the date the field audit begins. Where audits are performed on cost reports for multiple years or providers, the time frames shall be reasonably extended for the benefit of the DMAS and subject to the provisions of 12VAC30-90-123.

B. Documented delays on the part of the provider will automatically extend the above time frames to the extent of the time delayed.

C. Extensions of the time frames shall be granted to the department for good cause shown.

D. Disputes relating to the timeliness established in 12VAC30-90-123 and 12VAC30-90-124, or to the grant of extensions to the DMAS, shall be resolved by application to the Director of the DMAS or his designee.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 16, eff. July 1, 1996.

12VAC30-90-126 [Reserved]. (Reserved)

12VAC30-90-130 (Repealed.)

Historical Notes

Derived from VR460-03-4.1940:1 §§ 3.1 through 3.6, eff. August 1, 1993; amended, Virginia Register Volume 12, Issue 16, eff. July 1, 1996; repealed, Virginia Register Volume 17, Issue 18, eff. July 1, 2001.

12VAC30-90-136 Elements of capital payment methodology not subject to appeal

Subpart III Appeals

Elements of the capital payment methodology that shall not be subject to appeal shall be:

1. The definitions provided in Article 3 (12VAC30-90-35 et seq.) of Subpart II of this chapter, and the application of those definitions to the FRV rate calculation.

2. The transition policy described in 12VAC30-90-29.

3. The formula for determining the FRV per diem rate described in Article 3 of Subpart II of this chapter.

4. The calculation of the FRV rental amount described in Article 3 of Subpart II of this chapter.

5. The exclusion of certain beds from the transition policy as provided in Article 3 of Subpart II of this chapter.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia and Item 319 (II) of Chapter 1073 of the 2000 Acts of Assembly.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 18, eff. July 1, 2001.

12VAC30-90-137 [Reserved]. (Reserved)

12VAC30-90-140 Individual expense limitation

Subpart IV Individual Expense Limitation

In addition to operating costs being subject to peer group ceilings, costs are further subject to maximum limitations as defined in 12VAC30-90-290, Cost Reimbursement Limitations.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-03-4.1940:1 Part IV, eff. August 1, 1993; amended, Virginia Register Volume 12, Issue 16, eff. July 1, 1996.

12VAC30-90-150 Cost report preparation instructions

Subpart V Cost Report Preparation Instructions

Instructions for preparing NF cost reports will be provided by the DMAS.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-03-4.1940:1 Part V, eff. August 1, 1993; amended, Virginia Register Volume 12, Issue 16, eff. July 1, 1996.

Article 1 Plant Cost Applicable

12VAC30-90-160 Stock acquisition; merger of unrelated and related parties

Subpart VI Stock Transactions

Article 1 Plant Cost Applicable

A. The acquisition of the capital stock of a provider does not constitute a basis for revaluation of the provider's assets. Any cost associated with an acquisition of capital stock shall not be an allowable cost. The provider selling its stock continues as a provider after the sale, and the purchaser is only a stockholder of the provider.

B. In the case of a merger which combines two or more unrelated corporations under the regulations of the Code of Virginia, there will be only one surviving corporation. If the surviving corporation, which will own the assets and liabilities of the merged corporation, is not a provider, a Certificate of Public Need, if applicable, must be issued to the surviving corporation.

The nonsurviving corporation shall be subject to the policies applicable to terminated providers, including those relating to gain or loss on sales of NFs.

C. The statutory merger of two or more related parties or the consolidation of two or more related providers resulting in a new corporate entity shall be treated as a transaction between related parties. No revaluation shall be permitted for the surviving corporation.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia and Item 319 (II) of Chapter 1073 of the 2000 Acts of Assembly.
• Historical Notes: Derived from VR460-03-4.1940:1 Part VI, eff. August 1, 1993; amended, Virginia Register Volume 12, Issue 16, eff. July 1, 1996; Volume 17, Issue 18, eff. July 1, 2001.

Article 2 Capital Cost Applicable

12VAC30-90-165 Stock acquisition; merger of unrelated and related parties

Article 2 Capital Cost Applicable

A. The acquisition of the capital stock of a provider does not constitute a basis for revaluation of the provider's assets. Any cost associated with an acquisition of capital stock shall not be an allowable cost. The provider selling its stock continues as a provider after the sale, and the purchaser is only a stockholder of the provider.

B. In the case of a merger that combines two or more unrelated corporations under the Code of Virginia, there will be only one surviving corporation. If the surviving corporation that will own the assets and liabilities of the merged corporation is not a provider, a Certificate of Public Need, if applicable, must be issued to the surviving corporation.

The nonsurviving corporation shall be subject to the policies applicable to terminated providers, including those relating to gain or loss on sales of NFs.

C. The statutory merger of two or more related parties or the consolidation of two or more related providers resulting in a new corporate entity shall be treated as a transaction between related parties. No revaluation shall be permitted for the surviving corporation.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia and Item 319 (II) of Chapter 1073 of the 2000 Acts of Assembly.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 18, eff. July 1, 2001.

12VAC30-90-170 NATCEPs costs

Subpart VII Nurse Aide Training and Competency Evaluation Programs (NATCEPs)

A. The Omnibus Budget Reconciliation Act of 1989 (OBRA 89) amended § 1903(a)(2)(B) of the Social Security Act to fund actual NATCEPs costs incurred by NFs separately from the NF's medical assistance services reimbursement rates.

B. NATCEPs costs shall be as defined in Appendix I (12VAC30-90-270 through 12VAC30-90-276).

C. To calculate the reimbursement rate, NATCEPs costs contained in the most recently filed cost report shall be converted to a per diem amount by dividing allowable NATCEPs costs by the actual number of NF's patient days.

D. The NATCEPs interim reimbursement rate determined in subsection C of this section shall be added to the prospective operating cost and plant cost components or charges, whichever is lower, to determine the NF's prospective rate. The NATCEPs interim reimbursement rate shall not be adjusted for inflation.

E. Reimbursement of NF costs for training and competency evaluation of nurse aides must take into account the NF's use of trained nurse aides in caring for Medicaid, Medicare and private pay patients. Medicaid shall not be charged for that portion of NATCEPs costs that is properly charged to Medicare or private pay services. The final retrospective reimbursement for NATCEPs costs shall be the reimbursement rate as calculated from the most recently filed cost report by the methodology in subsection C of this section times the Medicaid patient days from the DMAS MMR-240.

F. Disallowance of nonreimbursable NATCEPs costs shall be reflected in the year in which the nonreimbursable costs were claimed.

G. Payments to providers for allowable NATCEPs costs shall not be considered in the comparison of the lower allowable reimbursement or charges for covered services, as outlined in 12VAC30-90-55 A.

H. Effective July 1, 2014, prospective NATCEPs per diem rates for each facility shall be the NATCEPs per diem rate in the base year inflated to the rate year based on inflation in 12VAC30-90-44. To calculate the NATCEPs per diem rate, NATCEPs costs in the base year shall be converted to a per diem amount by dividing allowable NATCEPs costs by the actual number of NF's patient days. In non-rebasing years, the prospective rate calculation shall be revised annually using costs from the next available year. The NATCEPs reimbursement rate determined in this subsection shall be added to the prospective operating cost, criminal records checks, and plant cost components.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-03-4.1940:1 Part VII, eff. October 1, 1990; amended, Virginia Register Volume 12, Issue 16, eff. July 1, 1996; Volume 17, Issue 18, eff. July 1, 2001; Volume 32, Issue 9, eff. February 11, 2016.

12VAC30-90-180 Criminal records checks

Subpart VIII Criminal Records Checks for Nursing Facility Employees

A. This section implements the requirements of § 32.1-126.01 of the Code of Virginia and Chapter 994 of the Acts of Assembly of 1993 (Item 313 T).

B. A licensed nursing facility shall not hire for compensated employment persons who have been convicted of:

1. Murder;

2. Abduction for immoral purposes as set out in § 18.2-48 of the Code of Virginia;

3. Assaults and bodily woundings as set out in Article 4 (§ 18.2-51 et seq.) of Chapter 4 of Title 18.2 of the Code of Virginia;

4. Arson as set out in Article 1 (§ 18.2-77 et seq.) of Chapter 5 of Title 18.2 of the Code of Virginia;

5. Pandering as set out in § 18.2-355 of the Code of Virginia;

6. Crimes against nature involving children as set out in § 18.2-361 of the Code of Virginia;

7. Taking indecent liberties with children as set out in §§ 18.2-370 or 18.2-370.1 of the Code of Virginia;

8. Abuse and neglect of children as set out in § 18.2-371.1 of the Code of Virginia;

9. Failure to secure medical attention for an injured child as set out in § 18.2-314 of the Code of Virginia;

10. Obscenity offenses as set out in § 18.2-374.1 of the Code of Virginia; or

11. Abuse or neglect of an incapacitated adult as set out in § 18.2-369 of the Code of Virginia.

C. The provider shall obtain a sworn statement or affirmation from every applicant disclosing any criminal convictions or pending criminal charges for any of the offenses specified in subsection B of this section regardless of whether the conviction or charges occurred in the Commonwealth.

D. The provider shall obtain an original criminal record clearance or an original criminal record history from the Central Criminal Records Exchange for every person hired. This information shall be obtained within 30 days from the date of employment and maintained in the employees' files during the term of employment and for a minimum of five years after employment terminates for whatever reason.

E. The provider may hire an applicant whose misdemeanor conviction is more than five years old and whose conviction did not involve abuse or neglect or moral turpitude.

F. Reimbursement to the provider will be handled through the cost reporting form provided by the DMAS and will be limited to the actual charges made by the Central Criminal Records Exchange for the records requested. Such actual charges will be a pass-through cost which is not a part of the operating or plant cost components.

G. Effective July 1, 2014, a prospective per diem rate shall be calculated. In a rebasing year, the calculation shall be based on the base year described in 12VAC30-90-44. In non-rebasing years, the prospective rate calculation shall be revised annually using the next available year. No adjustment for inflation shall be made. The criminal records checks rate shall be added to the prospective operating rate, nurse aide training and competency evaluation programs (NATCEPs), and plant cost components.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-03-4.1940:1 Part VIII, eff. July 1, 1994; amended, Virginia Register Volume 12, Issue 16, eff. July 1, 1996; Volume 32, Issue 9, eff. February 11, 2016.

12VAC30-90-190 Use of MMR-240

Subpart IX Use of MMR-240

All providers must use the data from computer printout MMR-240 based upon a 60-day accrual period.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-03-4.1940:1 Part IX, eff. July 1, 1994; amended, Virginia Register Volume 12, Issue 16, eff. July 1, 1996.

12VAC30-90-200 Commingled investment income

Subpart X Commingled Investment Income

DMAS shall treat funds commingled for investment purposes in accordance with PRM-15, § 202.6.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-03-4.1940:1 Part X, eff. July 1, 1994; amended, Virginia Register Volume 12, Issue 16, eff. July 1, 1996.

12VAC30-90-210 Provider notification

Subpart XI Provider Notification

DMAS shall notify providers of State Plan changes affecting reimbursement 30 days prior to the enactment of such changes.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-03-4.1940:1 Part XI, eff. July 1, 1994; amended, Virginia Register Volume 12, Issue 16, eff. July 1, 1996.

12VAC30-90-220 Start-up costs

Subpart XII Start-Up Costs and Organizational Costs

A. In the period of developing a provider's ability to furnish patient care services, certain costs are incurred. The costs incurred during this time of preparation are referred to as start-up costs. Since these costs are related to patient care services rendered after the time of preparation, they shall be capitalized as deferred charges and amortized over a 60-month time frame.

B. Start-up costs may include, but are not limited to, administrative and nursing salaries; heat, gas, and electricity; taxes, insurance; employee training costs; repairs and maintenance; housekeeping; and any other allowable costs incident to the start-up period. However, any costs that are properly identifiable as operating costs must be appropriately classified as such and excluded from start-up costs.

C. Start-up costs that are incurred immediately before a provider enters the Program and that are determined by the provider, subject to the DMAS approval, to be immaterial need not be capitalized but rather may be charged to operations in the first cost reporting period.

D. Where a provider incurs start-up costs while in the Program and these costs are determined by the provider, subject to the DMAS approval, to be immaterial, these costs shall not be capitalized but shall be charged to operations in the periods incurred.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-03-4.1940:1 Part XII, eff. July 1, 1993; amended, Virginia Register Volume 12, Issue 16, eff. July 1, 1996.

12VAC30-90-221 Time frames

A. Start-up costs are incurred from the time preparation begins on a newly constructed or purchased building, wing, floor, unit, or expansion thereof to the time the first patient (whether Medicaid or non-Medicaid) is admitted for treatment, or where the start-up costs apply only to nonrevenue producing patient care functions or nonallowable functions, to the time the areas are used for their intended purposes.

B. If a provider intends to prepare all portions of its entire facility at the same time, start-up costs for all portions of the facility shall be accumulated in a single deferred charge account and shall be amortized when the first patient is admitted for treatment.

C. If a provider intends to prepare portions of its facility on a piecemeal basis (i.e., preparation of a floor or wing of a provider's facility is delayed), start-up costs shall be capitalized and amortized separately for the portion or portions of the provider's facility prepared during different time periods.

D. Moreover, if a provider expands its NF by constructing or purchasing additional buildings or wings, start-up costs shall be capitalized and amortized separately for these areas.

E. Depreciation time frames.

1. Costs of the provider's facility and building equipment shall be depreciated using the straight line method over the lives of these assets starting with the month the first patient is admitted for treatment.

2. Where portions of the provider's NF are prepared for patient care services after the initial start-up period, those asset costs applicable to each portion shall be depreciated over the remaining lives of the applicable assets. If the portion of the NF is a nonrevenue-producing patient care area or nonallowable area, depreciation shall begin when the area is opened for its intended purpose. Costs of major movable equipment, however, shall be depreciated over the useful life of each item starting with the month the item is placed into operation.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia and Item 319 (II) of Chapter 1073 of the 2000 Acts of Assembly.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 16, eff. July 1, 1996; amended, Virginia Register Volume 17, Issue 18, eff. July 1, 2001.

12VAC30-90-222 Organizational costs

A. Organizational costs are those costs directly incident to the creation of a corporation or other form of business. These costs are an intangible asset in that they represent expenditures for rights and privileges which have a value to the enterprise. The services inherent in organizational costs extend over more than one accounting period and thus affect the costs of future periods of operations.

B. Allowable organizational costs shall include, but not be limited to, legal fees incurred in establishing the corporation or other organization (such as drafting the corporate charter and by-laws, legal agreements, minutes of organizational meeting, terms of original stock certificates), necessary accounting fees, expenses of temporary directors and organizational meetings of directors and stockholders and fees paid to states for incorporation.

C. The following types of costs shall not be considered allowable organizational costs: costs relating to the issuance and sale of shares of capital stock or other securities, such as underwriters fees and commissions, accountant's or lawyer's fees, cost of qualifying the issues with the appropriate state or federal authorities, stamp taxes, etc.

D. Allowable organization costs shall generally be capitalized by the organization. However, if DMAS concludes that these costs are not material when compared to total allowable costs, they may be included in allowable indirect operating costs for the initial cost reporting period. In all other circumstances, allowable organization costs shall be amortized ratably over a period of 60 months starting with the month the first patient is admitted for treatment.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 16, eff. July 1, 1996.

12VAC30-90-223 [Reserved]. (Reserved)

12VAC30-90-230 Access to records

Subpart XIII DMAS Authorization

A. DMAS shall be authorized to request and review, either through a desk or field audit, all information related to the provider's cost report that is necessary to ascertain the propriety and allocation of costs (in accordance with Medicare and Medicaid rules, regulations, and limitations) to patient care and nonpatient care activities.

B. Examples of such information shall include, but not be limited to, all accounting records, mortgages, deeds, contracts, meeting minutes, salary schedules, home office services, cost reports, and financial statements.

C. This access also applies to related organizations as defined in 12VAC30-90-51 who provide assets and other goods and services to the provider.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-03-4.1940:1 Part XIII, eff. October 1, 1990; amended, Virginia Register Volume 12, Issue 16, eff. July 1, 1996.

12VAC30-90-240 Home office operating costs

Subpart XIV Home Office Costs

A. Home office operating costs shall be allowable to the extent they are reasonable, relate to patient care, and provide cost savings to the provider.

B. Provider purchases from related organizations, whether for services, or supplies, shall be limited to the lower of the related organizations actual cost or the price of comparable purchases made elsewhere.

C. Home office operating costs shall be allocated in accordance with § 2150.3, PRM-15.

D. Home office costs associated with providing management services to nonrelated entities shall not be recognized as allowable reimbursable cost.

E. Allowable and nonallowable home office costs shall be recognized in accordance with § 2150.2, PRM-15.

F. Item 398 D Chapter 723 of 1987 Acts of Assembly (as amended), effective April 8, 1987, eliminated reimbursement of return on equity capital to proprietary providers for periods or portions thereof on or after July 1, 1987.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia and Item 319 (II) of Chapter 1073 of the 2000 Acts of Assembly.
• Historical Notes: Derived from VR460-03-4.1940:1 Part XIV, eff. October 1, 1990; amended, Virginia Register Volume 12, Issue 16, eff. July 1, 1996; Volume 17, Issue 18, eff. July 1, 2001.

12VAC30-90-250 Lump sum payment

Subpart XV Refund of Overpayments

When the provider files a cost report indicating that an overpayment has occurred, full refund shall be remitted with the cost report. In cases where DMAS discovers an overpayment during desk audit, field audit, or final settlement, DMAS shall promptly send the first demand letter requesting a lump sum refund.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia and Item 319 (II) of Chapter 1073 of the 2000 Acts of Assembly.
• Historical Notes: Derived from VR460-03-4.1940:1 Part XV, eff. July 1, 1992; amended, Virginia Register Volume 12, Issue 16, eff. July 1, 1996; Volume 17, Issue 18, eff. July 1, 2001.

12VAC30-90-251 Offset

If the provider has been overpaid for a particular fiscal year and has been underpaid for another fiscal year, the underpayment shall be offset against the overpayment. So long as the provider has an overpayment balance, any underpayments discovered by subsequent review or audit shall be used to reduce the balance of the overpayment.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 16, eff. July 1, 1996.

12VAC30-90-252 Payment schedule

A. If the provider cannot refund the total amount of the overpayment (i) at the time it files a cost report indicating that an overpayment has occurred, the provider shall request in writing an extended repayment schedule at the time of filing, or (ii) within 30 days after receiving the DMAS demand letter, the provider shall promptly request in writing an extended repayment schedule.

B. DMAS may establish a repayment schedule of up to 12 months to recover all or part of an overpayment or, if a provider demonstrates that repayment within a 12-month period would create severe financial hardship, the Director of DMAS may approve a repayment schedule of up to 36 months.

C. A provider shall have no more than one extended repayment schedule in place at one time. If subsequent audits identify additional overpayment, the full amount shall be repaid within 30 days unless the provider submits further documentation supporting a modification to the existing extended repayment schedule to include the additional amounts.

D. If, during the time an extended repayment schedule is in effect, the provider ceases to be a participating provider or fails to file a cost report in a timely manner, the outstanding balance shall become immediately due and payable.

E. When a repayment schedule is used to recover only part of an overpayment, the remaining amount shall be recovered from interim payments to the provider or by lump sum payments.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 16, eff. July 1, 1996.

12VAC30-90-253 Extension request documentation

In the written request for an extended repayment schedule, the provider shall document the need for an extended (beyond 30 days) repayment and submit a written proposal scheduling the dates and amounts of repayments. The provider must make payments in accordance with the proposed schedule while the schedule is pending approval. If DMAS approves the schedule, DMAS shall send the provider written notification of the approved repayment schedule, which shall be effective retroactive to the date the provider submitted the proposal.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia and Item 319 (II) of Chapter 1073 of the 2000 Acts of Assembly.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 16, eff. July 1, 1996; amended, Virginia Register Volume 17, Issue 18, eff. July 1, 2001.

12VAC30-90-254 Interest charge on extended repayment

A. Once an initial determination of overpayment has been made, DMAS shall undertake full recovery of such overpayment whether or not the provider disputes, in whole or in part, the initial determination of overpayment. If an appeal follows, interest shall be waived during the period of administrative appeal of an initial determination of overpayment.

B. Interest charges on the unpaid balance of any overpayment shall accrue pursuant to § 32.1-313 of the Code of Virginia from the date the director's determination becomes final.

C. The director's determination shall be deemed to be final on (i) the due date of any cost report filed by the provider indicating that an overpayment has occurred, or (ii) the issue date of any notice of overpayment, issued by DMAS, if the provider does not file an appeal, or (iii) the issue date of any administrative decision issued by DMAS after an informal fact finding conference, if the provider does not file an appeal, or (iv) the issue date of any administrative decision signed by the director, regardless of whether a judicial appeal follows. In any event, interest shall be waived if the overpayment is completely liquidated within 30 days of the date of the final determination. In cases in which a determination of overpayment has been judicially reversed, the provider shall be reimbursed that portion of the payment to which it is entitled, plus any applicable interest which the provider paid to DMAS.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 16, eff. July 1, 1996.

12VAC30-90-255 [Reserved]. (Reserved)

12VAC30-90-257 Credit balance reporting

A. Definitions. The following words and terms when used in this regulation shall have the following meanings unless the context clearly indicates otherwise:

"Claim" means a bill consistent with 12VAC30-20-180 submitted by a provider to the department for services furnished to a recipient.

"Credit balance" means an excess or overpayment made to a provider by Medicaid as a result of patient billings.

B. Credit balances may occur when a provider's reimbursement for services it provides exceeds the allowable amount or when the reimbursement has been for unallowable costs, resulting in an overpayment. Credit balances also may occur when a provider receives payments from Medicaid or another third party payer for the same services.

C. For a credit balance arising on a Medicaid claim within three years of the date paid by the department, the NF shall submit an adjustment claim. For credit balances arising on claims over three years old, the NF shall submit a check for the balance due and a copy of the original DMAS payment.

D. A periodic audit shall be conducted of an NF's claim adjustments of Medicaid credit balance data. NFs shall maintain an audit trail back to the underlying accounts receivable records supporting each claim adjusted for credit balances.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 18, eff. July 1, 2003; amended, Virginia Register Volume 32, Issue 6, eff. December 31, 2015.

12VAC30-90-258 [Reserved]. (Reserved)

12VAC30-90-260 (Repealed.)

Subpart XVI Revaluation of Assets [Repealed]

Historical Notes

Derived from VR460-03-4.1940:1 Part XVI, eff. July 1, 1992; amended, Virginia Register Volume 12, Issue 16, eff. July 1, 1996; repealed, Virginia Register Volume 17, Issue 18, eff. July 1, 2001.

12VAC30-90-264 Specialized care services

Subpart XVII Specialized Care Services

Specialized care services provided in conformance with 12VAC30-60-40 E and H, 12VAC30-60-320, and 12VAC30-60-340 shall be reimbursed under the following methodology. The nursing facilities that provide adult specialized care for the categories of Ventilator Dependent Care, will be placed in one group for rate determination. The nursing facilities that provide pediatric specialized care in a dedicated pediatric unit of eight beds or more will be placed in a second group for rate determination.

1. Routine operating cost. Routine operating cost shall be defined as in 12VAC30-90-271 and 12VAC30-90-272. To calculate the routine operating cost reimbursement rate, routine operating cost shall be converted to a per diem amount by dividing it by actual patient days. Effective July 1, 2016, the base year for routine operating cost shall be the most recently settled cost reports with a fiscal year ending in a calendar year for all specialized care facilities as of the end of the calendar year prior to the prospective rate year.

2. Allowable cost identification and cost reimbursement limitations. The provisions of Article 5 (12VAC30-90-50 et seq.) of Subpart II of Part II of this chapter and of Appendix III (12VAC30-90-290) of Part III of this chapter shall apply to specialized care cost and reimbursement.

3. Routine operating cost rates. Each facility shall be reimbursed a prospective rate for routine operating costs. This rate will be the lesser of the facility-specific prospective routine operating ceiling, or the facility-specific prospective routine operating cost per day plus an efficiency incentive. This efficiency incentive shall be calculated by the same method as in 12VAC30-90-41.

4. Facility-specific prospective routine operating ceiling. Each nursing facility's prospective routine operating ceiling shall be calculated as:

a. Statewide ceiling. The statewide routine operating ceiling shall be $415 as of July 1, 2002. This routine operating ceiling amount shall be adjusted for inflation based on 12VAC30-90-41. Effective July 1, 2016, the routine operating ceiling shall be $573.09 as of state fiscal year 2015 and shall be adjusted for inflation based on 12VAC-30-90-44 to the upcoming state fiscal year, the prospective rate year.

b. The portion of the statewide routine operating ceiling relating to nursing salaries (as determined by the 1994 audited cost report data, or 67.22%) will be wage adjusted using a normalized wage index. The normalized wage index shall be the wage index applicable to the individual provider's geographic location under Medicare rules of reimbursement for skilled nursing facilities, divided by the statewide average of such wage indices across the state. This normalization of wage indices shall be updated January 1, after each time the CMS publishes wage indices for skilled nursing facilities. Updated normalization shall be effective for fiscal years starting on and after the January 1 for which the normalization is calculated. Effective July 1, 2016, the normalized wage index for the federal fiscal year following the base year shall be applied to the state fiscal year ceiling.

5. Facility-specific prospective routine operating base cost per day. The facility-specific routine operating cost per day to be used in the calculation of the routine operating rate and the efficiency incentive shall be the actual routine cost per day from the most recent fiscal year's cost report, adjusted for inflation based on 12VAC30-90-41. Effective July 1, 2016, the routine operating base cost per day in subdivision 1 of this subsection shall be adjusted for inflation based on 12VAC30-90-44 to the upcoming state fiscal year, the prospective rate year.

6. Interim rates. Interim rates, for processing claims during the year, shall be calculated from the most recent settled cost report available at the time the interim rates must be set, except that failure to submit a cost report timely may result in adjustment to interim rates as provided elsewhere. Effective July 1, 2016, this subdivision is no longer applicable.

7. Ancillary costs. Specialized care ancillary costs will be paid on a pass-through basis for those Medicaid specialized care patients who do not have Medicare or any other sufficient third-party insurance coverage. Ancillary costs will be reimbursed as follows:

a. All covered ancillary services, except kinetic therapy devices, will be reimbursed for reasonable costs as defined in the current NHPS. Effective for specialized care days on or after January 15, 2007, reimbursement for reasonable costs shall be subject to a ceiling. The ceiling shall be $238.81 per day for calendar year 2004 (150% of average costs) and shall be inflated to the appropriate provider fiscal year. For cost report years beginning in each calendar year, ancillary ceilings will be inflated based on 12VAC30-90-41. See 12VAC30-90-290 for the cost reimbursement limitations. Effective July 1, 2016, the ancillary ceiling of $300.38 in state fiscal year 2015, inclusive of kinetic therapy devices, shall be adjusted for inflation to the prospective rate year based on 12VAC30-90-44.

b. Kinetic therapy devices will have a limit per day (based on 1994 audited cost report data inflated to the rate period). See 12VAC30-90-290 for the cost reimbursement limitations.

c. Kinetic therapy devices will be reimbursed only if a resident is being treated for wounds that meet the following wound care criteria. Residents receiving this wound care must require kinetic bed therapy (that is, low air loss mattresses, fluidized beds, or rotating or turning beds) and require treatment for a grade (stage) IV decubitus, a large surgical wound that cannot be closed, or second to third degree burns covering more than 10% of the body.

8. Covered ancillary services are defined as follows: laboratory, X-ray, medical supplies (e.g., infusion pumps, incontinence supplies), physical therapy, occupational therapy, speech therapy, inhalation therapy, IV therapy, enteral feedings, and kinetic therapy. The following are not specialized care ancillary services and are excluded from specialized care reimbursement: physician services, psychologist services, total parenteral nutrition (TPN), and drugs. These services must be separately billed to DMAS. An interim rate for the covered ancillary services will be determined (using data from the most recent settled cost report) by dividing allowable ancillary costs by the number of patient days for the same cost reporting period. The interim rate will be retroactively cost settled based on the specialized care nursing facility cost reporting period.

9. Capital costs. Effective July 1, 2016, capital cost reimbursement rate shall be based on subsection C of 12VAC30-90-44 in accordance with 12VAC30-90-35, 12VAC30-90-36, and 12VAC30-90-37, except that the required occupancy percentage shall not be separately applied to specialized care. To determine the capital cost related to specialized care patients, the following calculation shall be applied.

a. Licensed beds, including specialized care beds, multiplied by days in the cost reporting period, shall equal available days.

b. The required occupancy days shall equal the required occupancy percentage multiplied by available days.

c. The required occupancy days minus actual resident days, including specialized care days, shall equal the shortfall of days. If the shortfall of days is negative, the shortfall of days shall be zero.

d. Actual resident days, not including specialized care days, plus the shortfall of days shall equal the minimum number of days to be used to calculate the capital cost per day.

10. Nurse aide training and competency evaluation programs (NATCEP) costs. NATCEP costs will be paid on a pass-through basis in accordance with the current NHPS. Effective July 1, 2016, NATCEP costs shall be paid on a prospective basis in accordance with 12VAC30-90-170.

11. Pediatric routine operating cost rate. For pediatric specialized care in a distinct part pediatric specialized care unit, one routine operating cost ceiling will be developed. The routine operating cost ceiling will be $418 as of July 1, 2002. Effective July 1, 2016, the pediatric routine operating cost ceiling shall be $577.24.

a. The statewide operating ceiling shall be adjusted for each nursing facility in the same manner as described in subdivision 4 of this section.

b. The final routine operating cost reimbursement rate shall be computed as described for other than pediatric units in subdivision 3 of this section.

12. Pediatric unit capital cost. Pediatric unit capital costs will be reimbursed in accordance with subdivision 9 of this section, except that the occupancy requirement shall be 70% rather than the required occupancy percentage.

13. The cost reporting requirements of 12VAC30-90-70 and 12VAC30-90-80 shall apply to specialized care providers.

14. Effective July 1, 2020, through June 30, 2022, specialized care operating rates shall be increased annually by inflation based on 12VAC30-90-44.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 14, Issue 1, eff. December 1, 1997; amended, Virginia Register Volume 17, Issue 18, eff. July 1, 2001; Volume 20, Issue 19, eff. July 1, 2004; Volume 23, Issue 14, eff. April 18, 2007; Volume 25, Issue 3, eff. November 27, 2008; Volume 30, Issue 19, eff. June 18, 2014; Volume 34, Issue 11, eff. February 21, 2018; Volume 37, Issue 7, eff. December 23, 2020.

12VAC30-90-266 Traumatic Brain Injury (TBI) payment

DMAS shall provide a fixed per day payment for nursing facility residents with TBI served in the program in accordance with resident and provider criteria, in addition to the reimbursement otherwise payable under the provisions of the Nursing Home Payment System. Effective for dates of service on and after August 19, 1998, a per day rate add-on shall be paid for recipients who meet the eligibility criteria for these TBI payments and who are residents in a designated nursing facility TBI unit of 20 beds or more that meets the provider eligibility criteria. The rate add-on for any qualifying provider's fiscal year shall be reviewed annually to determine the appropriateness of the amount, not to exceed $50 per patient day, and any changes will be published and distributed to the providers. (Refer to 12VAC30-90-330, Traumatic brain injury diagnoses, for related resident and provider requirements.)

History

• Statutory Authority: § 32.1-325 of the Code of Virginia and Item 319 (II) of Chapter 1073 of the 2000 Acts of Assembly.
• Historical Notes: Derived from Virginia Register Volume 14, Issue 22, eff. August 19, 1998; amended, Virginia Register Volume 17, Issue 18, eff. July 1, 2001.

12VAC30-90-267 Private room differential

A. Payment shall be made for a private room or other accommodations more expensive than semi-private (two or more bed accommodations) only when such accommodations are medically necessary. Private rooms will be considered necessary when the resident's condition requires the resident to be isolated for his own health or that of others.

B. Physician certification justifying the private room must be on file prior to the resident's discharge from the semi-private room. The term "isolation" applies when treating a number of physical and mental conditions. These conditions include communicable diseases that require isolation of the resident for certain periods. Private room accommodations may also be necessary for residents whose symptoms or treatments are likely to alarm or disturb others in the same room.

C. Reimbursement for private rooms will only be made when authorized by the Virginia Department of Medical Assistance Services.

D. The Medicaid private room differential shall be calculated by applying the percentage difference between the facility's private and semi-private room charges to the total case-mix neutral Medicaid rate for the facility.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 9, eff. February 11, 2016.

12VAC30-90-270 Uniform Expense Classification

Appendix I Uniform Expense Classification

This appendix describes the classification of expenses applicable to the Nursing Facility Payment System.

Allowable expenses shall meet all of the following requirements: necessity, reasonableness, nonduplication, related to patient care, not exceeding the limits and/or ceilings established in the Payment System and meet applicable Medicare principles of reimbursement. All of the references to 12VAC30-90-270 occurring in previous Part II shall be understood to include 12VAC30-90-270 through 12VAC30-90-276.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia and Item 319 (II) of Chapter 1073 of the 2000 Acts of Assembly.
• Historical Notes: Derived from VR460-03-4.1941:1, eff. July 1, 1994; amended, Virginia Register Volume 14, Issue 1, eff. December 1, 1997; Volume 17, Issue 18, eff. July 1, 2001.

12VAC30-90-271 Direct patient care operating

A. Nursing service expenses.

1. Salary -- nursing administration. Gross salary (includes sick pay, holiday pay, vacation pay, staff development pay and overtime pay) of all licensed nurses in supervisory positions defined as follows (Director of Nursing, Assistant Director of Nursing, nursing unit supervisors, patient care coordinators and MDS coordinators).

2. Salaries -- RNs. Gross salary of registered nurses.

3. Salaries -- LPNs. Gross salary of licensed practical nurses.

4. Salaries -- Nurse aides. Gross salary of certified nurse aides.

5. Salaries -- Quality assurance nurses. Gross salary of licensed nurses who function as quality assurance coordinators and are responsible for quality assurance activities and programs. Quality assurance activities and programs are concerned with resident care and not with the administrative support that is needed to document the care. If a quality assurance coordinator is employed by the home office and spends a percentage of time at nursing facilities, report directly allocated costs to the nursing facility in this category rather than under the home office operating costs.

6. Nursing employee benefits. Benefits related to registered nurses, licensed practical nurses, certified nurse aides, quality assurance nurses, and nursing administration personnel as defined in subdivision 1 of this subsection. See 12VAC30-90-272 B for description of employee benefits.

7. Contract nursing services. Cost of registered nurses, licensed practical nurses, certified nurse aides, and quality assurance nurses on a contract basis.

8. Supplies. Cost of supplies, including nursing and charting forms, medication and treatment records, physician order forms.

9. Professional fees. Medical director and pharmacy consultant fees.

B. Minor medical and surgical supplies.

1. Salaries -- medical supply. Gross salary of personnel responsible for procurement, inventory and distribution of minor medical and surgical supplies.

2. Medical supply employee benefits. Benefits related to medical supply personnel. See 12VAC30-90-272 B for description of employee benefits.

3. Supplies. Cost of items for which a separate identifiable charge is not customarily made, including, but not limited to, colostomy bags; dressings; chux; rubbing alcohol; syringes; patient gowns; basins; bed pans; ice-bags and canes, crutches, walkers, wheel chairs, traction equipment and other durable medical equipment for multi-patient use.

4. Oxygen. Cost of oxygen for which a separate charge is not customarily made.

5. Nutrient/tube feedings. Cost of nutrients for tube feedings.

6. Incontinence services. Cost of disposable and nondisposable incontinence supplies. The laundry supplies or purchased commercial laundry service for nondisposable incontinent services.

C. Ancillary service cost. Allowable ancillary service costs represents gross salary and related employee benefits of those employees engaged in covered ancillary services to Medicaid recipients, cost of all supplies used by the respective ancillary service departments, cost of ancillary services performed on a contract basis by other than employees and all other costs allocated to the ancillary service cost centers in accordance with Medicare principles of reimbursement.

Following is a listing of all covered ancillary services:

1. Radiology

2. Laboratory

3. Respiratory therapy

4. Physical therapy

5. Occupational therapy

6. Speech therapy

7. EKG

8. EEG

9. Medical supplies charged to patient

10. Kinetic therapy devices.

11. IV therapy.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 14, Issue 1, eff. December 1, 1997; amended, Virginia Register Volume 18, Issue 18, eff. July 1, 2002; Volume 20, Issue 19, eff. July 1, 2004; Volume 23, Issue 20, eff. August 25, 2007.

12VAC30-90-272 Indirect patient care operating costs

A. Administrative and general.

1. Administrator/owner assistant administrator. Compensation of individuals responsible for administering the operations of the nursing facility. (See 12VAC30-90-50 and Appendix III (12VAC30-90-290) for limitations.)

2. Other administrative and fiscal services. Gross salaries of all personnel in administrative, personnel, fiscal, billing and admitting, communications and purchasing departments.

3. Management fees. Cost of fees for providing necessary management services related to nursing facility operations. (See Appendix III (12VAC30-90-290) for limitations.)

4. Professional fees -- accounting. Fees paid to independent outside auditors and accountants.

5. Professional fees -- legal. Fees paid to attorneys. (See Appendix III (12VAC30-90-290) for limitations.)

6. Professional fees -- other. Fees, other than accounting or legal, for professional services related to nursing facility patient care.

7. Director's fees. Fees paid for attendance at scheduled meetings which serve as reimbursement for time, travel, and services provided. (See Appendix III (12VAC30-90-290) for limitations.)

8. Membership fees. Fees related to membership in health care organizations which promote objectives in the providers' field of health care activities. (See Appendix III (12VAC30-90-290) for limitations.)

9. Advertising (classified). Cost of advertising to recruit new employees and yellow pages advertising.

10. Public relations. Cost of promotional expenses including brochures and other informational documents regarding the nursing facility.

11. Telephone. Cost of telephone service used by employees of the nursing facility.

12. Subscriptions. Cost of subscribing to newspapers, magazines, and periodicals.

13. Office supplies. Cost of supplies used in administrative departments (e.g., pencils, papers, erasers, staples).

14. Minor furniture and equipment. Cost of furniture and equipment which does not qualify as a capital asset.

15. Printing and postage. Cost of reproducing documents which are reasonable, necessary and related to nursing facility patient care and cost of postage and freight charges.

16. Travel. Cost of travel (airfare, auto mileage, lodging, meals, etc. by administrator or other authorized personnel on official nursing facility business). (See 12VAC30-90-290 for limitations.)

17. Auto. All costs of maintaining nursing facility vehicles, including gas, oil, tires, licenses, maintenance of such vehicles.

18. License fees. Fees for licenses, including state, county, and local business licenses, and VHSCRC filing fees.

19. Liability insurance. Cost of insuring the facility against liability claims, including malpractice.

20. Interest. Other than mortgage and equipment.

21. Amortization/start-up costs. Amortization of allowable Start-Up Costs (See 12VAC30-90-220).

22. Amortization/organizational costs. Amortization of allowable organization costs (See 12VAC30-90-220).

B. Employee benefits.

1. FICA (Social Security). Cost of employer's portion of Social Security Tax.

2. State unemployment. State unemployment insurance costs.

3. Federal unemployment. Federal unemployment insurance costs.

4. Workers' compensation. Cost of workers' compensation insurance.

5. Health insurance. Cost of employer's contribution to employee health insurance.

6. Group life insurance. Cost of employer's contribution to employee group life insurance.

7. Pension plan. Employer's cost of providing pension program for employees.

8. Other employee benefits. Cost of awards and recognition ceremonies for recognition and incentive programs, disability insurance, child care, and other commonly offered employee benefits which are nondiscriminatory.

C. Dietary expenses.

1. Salaries. Gross salary of kitchen personnel, including dietary supervisor, cooks, helpers and dishwashers.

2. Supplies. Cost of items such as soap, detergent, napkins, paper cups, and straws.

3. Dishes and utensils. Cost of knives, forks, spoons, plates, cups, saucers, bowls and glasses.

4. Consultants. Fees paid to consulting dietitians.

5. Purchased services. Costs of dietary services performed on a contract basis.

6. Food. Cost of raw food.

7. Nutrient oral feedings. Cost of nutrients in oral feedings.

D. Housekeeping expenses.

1. Salaries. Gross salary of housekeeping personnel, including housekeepers, maids and janitors.

2. Supplies. Cost of cleaners, soap, detergents, brooms, and lavatory supplies.

3. Purchased services. Cost of housekeeping services performed on a contract basis.

E. Laundry expenses.

1. Salaries. Gross salary of laundry personnel.

2. Linen. Cost of sheets, blankets, and pillows.

3. Supplies. Cost of such items as soap, detergent, starch and bleach.

4. Purchased services. Cost of other services, including commercial laundry service.

F. Maintenance and operation of plant.

1. Salaries. Gross salary of personnel involved in operating and maintaining the physical plant, including maintenance men or plant engineer and security services.

2. Supplies. Cost of supplies used in maintaining the physical plant, including light bulbs, nails, lumber, glass.

3. Painting. Supplies and contract services.

4. Gardening. Supplies and contract services.

5. Heating. Cost of heating oil, natural gas, or coal.

6. Electricity. Self-explanatory.

7. Water, sewer, and trash removal. Self-explanatory.

8. Purchased services. Cost of maintaining the physical plant, fixed equipment, movable equipment and furniture and fixtures on a contract basis.

9. Repairs and maintenance. Supplies and contract services involved with repairing the facility's capital assets.

G. Medical records expenses.

1. Salaries -- medical records. Gross salary of licensed medical records personnel and other department personnel.

2. Utilization review. Fees paid to physicians attending utilization review committee meetings.

3. Supplies. All supplies used in the department.

4. Purchased services. Medical records services provided on a contract basis.

H. Social service expenses.

1. Salaries. Salary of personnel providing medically-related social services. A facility with more than 120 beds must employ a full-time qualified social worker.

2. Purchased services. Cost of medically-related social services provided on a contract basis.

3. Supplies. Cost of all supplies used in the department.

I. Patient activity expenses.

1. Salaries. Gross salary of personnel providing recreational programs to patients, such as arts and crafts, church services and other social activities.

2. Supplies. Cost of items used in the activities program (i.e., games, art and craft supplies and puzzles).

3. Purchased services. Cost of services provided on a contract basis.

J. Educational activities expenses. (Other than NATCEPs costs, see 12VAC30-90-270.)

1. Salaries. Gross salaries of training personnel.

2. Supplies. Cost of all supplies used in this activity.

3. Purchased services. Cost of training programs provided on a contract basis.

K. Other nursing administrative costs.

1. Salaries -- other nursing administration. Gross salaries of ward clerks and nursing administration support staff.

2. Subscriptions. Cost of subscribing to newspapers, magazines and periodicals.

3. Office supplies. Cost of supplies used in nursing administrative departments (e.g., pencils, papers, erasers, staples).

4. Purchased services. Cost of nursing administrative consultants, ward clerks, nursing administration support staff performed on a contract basis.

5. Advertising (classified). Cost of advertising to recruit all nursing service personnel.

L. Home office costs. Allowable operating costs incurred by a home office which are directly assigned to the nursing facility or pooled operating costs, with the exception of quality assurance coordinator salary and employee benefits that are reported under direct patient care operating, that are allocated to the nursing facility in accordance with 12VAC30-90-240.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 14, Issue 1, eff. December 1, 1997; amended, Virginia Register Volume 17, Issue 18, eff. July 1, 2001; Volume 18, Issue 18, eff. July 1, 2002.

12VAC30-90-273 Plant costs

A. Interest.

1. Building interest. Interest paid or accrued on notes, mortgages and other loans, the proceeds of which were used to purchase the nursing facility's real property. (See 12VAC30-90-30 for Limitations.)

2. Equipment interest. Interest paid or accrued on notes, chattel mortgages and other loans, the proceeds of which were used to purchase the nursing facility's equipment. (See 12VAC30-90-30 for Limitations.)

B. Depreciation (12VAC30-90-50).

1. Building depreciation. Depreciation on the nursing facility's building.

2. Building improvement depreciation. Depreciation on major additions or improvements to the nursing facility (i.e., new laundry or dining room).

3. Land improvement depreciation. Depreciation of improvements made to the land occupied by the facility (i.e., paving, landscaping).

4. Fixed and movable equipment depreciation. Depreciation on capital assets classified as fixed and movable equipment in compliance with American Hospital Association Guidelines.

5. Leasehold improvement depreciation. Depreciation on major additions or improvements to building or plant where the facility is leased and the costs are incurred by the lessee (tenant).

6. Automobile depreciation. Depreciation of those vehicles utilized solely for facility/patient services.

C. Lease/rental.

1. Building rental. Rental amounts paid by the provider on all rented or leased real property (land and building).

2. Equipment rental. Rental amounts paid by the provider on leased or rented furniture and equipment.

D. Taxes.

1. Property taxes. Amount of taxes paid on the facility's property, plant and equipment.

E. Insurance.

1. Property insurance. Cost of fire and casualty insurance on buildings and equipment.

2. Mortgage insurance. Premiums required by the lending institution, if the lending institution is made a direct beneficiary and if premiums meet Medicare principles of reimbursement criteria for allowability.

F. Amortization -- deferred financing costs. Amortization of deferred financing costs (those costs directly incident to obtaining financing of allowable capital costs related to patient care services such as legal fees; guarantee fees; service fees; feasibility studies; loan points; printing and engraving costs; rating agency fees). These deferred financing costs should be capitalized and amortized over the life of the mortgage.

G. Home office capital costs. Allowable plant costs incurred by a home office which are directly identified to the nursing facility or pooled capital costs that are allocated to the nursing facility in accordance with 12VAC30-90-240.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia and Item 322(D)(2a) of Chapter 912 of the 1996 Acts of Assembly.
• Historical Notes: Derived from Virginia Register Volume 14, Issue 1, eff. December 1, 1997.

12VAC30-90-274 Nonallowable expenses

Nonallowable expenses include but are not limited to the following:

A. Barber and beautician. Direct and indirect operating and capital costs related to the provision of beauty and barber services to patients.

B. Personal items. Cost of personal items, such as cigarettes, toothpaste, and shaving cream sold to patients.

C. Vending machines. Cost of items sold to employees and patients including candy bars and soft drinks.

D. Television/telephones. Cost of television sets and telephones used in patient rooms.

E. Gift shop. Direct and indirect operating and capital cost related to the provision of operating a gift shop.

F. Insurance -- officers. Cost of life insurance on officers, owners and key employees where the provider is a direct or indirect beneficiary.

G. Income taxes. Taxes on net income levied or expected to be levied by any governmental entity.

H. Contributions. Amounts donated to charitable or other organizations which have no direct effect on patient care.

I. Deductions from revenue. Accounts receivable written off as bad debts, charity, courtesy, or from contractual agreements are nonallowable expenses.

J. Advertising. The cost of advertisements in magazines, newspapers, trade publications, radio, and television and certain home office expenses as defined in PRM-15.

K. Cafeteria. Cost of meals to other than patients.

L. Pharmacy. Cost of all prescribed legend and nonlegend drugs.

M. Medical supplies. Cost of medical supplies to other than patients.

N. Plant costs. All plant costs not available for nursing facility patient care-related activities are nonreimbursable plant costs.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia and Item 322(D)(2a) of Chapter 912 of the 1996 Acts of Assembly.
• Historical Notes: Derived from Virginia Register Volume 14, Issue 1, eff. December 1, 1997.

12VAC30-90-275 Nurse Aide Training and Competency Evaluation Programs (NATCEPs) costs

A. Facility-based NATCEPs costs.

1. Salary -- staff development. Gross salary of personnel conducting the nurse aide training and competency evaluation programs.

2. Employee benefits. Benefits related to personnel conducting the nurse aide training and competency evaluation programs. See 12VAC30-90-272 B for description of employee benefits.

3. Contract services. Cost of state qualified nurse aide instructors paid on a contract basis.

4. Supplies. Cost of supplies used in conducting NATCEPs (e.g., pencils, papers, erasers, staples, textbooks and other required course materials).

5. License fees. Cost of nurse aide registry application fees and competency evaluation testing fees paid by the nursing facilities on behalf of the certified nurse aides.

6. Housekeeping expenses. Housekeeping expense as defined in 12VAC30-90-272 D, for nursing facilities which dedicate space in the facility to NATCEPs activities 100%. Housekeeping expenses shall be allocated to the NATCEPs operations in accordance with Medicare Principles of Reimbursement.

7. Maintenance and operation of plant. Maintenance and operation of plant as defined in 12VAC30-90-272 F, for nursing facilities which dedicate space in the facility to NATCEPs activities 100%.

Maintenance and operation of plant expense shall be allocated to the NATCEPs operations in accordance with Medicare Principles of Reimbursement.

8. Other direct expenses. Any other direct costs associated with the operation of the NATCEPs. There shall be no allocation of indirect patient care operating costs as defined in 12VAC30-90-272, except housekeeping and maintenance and operation of plant expenses.

B. Nonfacility-based NATCEPs costs.

1. Contract services. Cost of training and competency evaluation of nurse aides paid to an outside state approved nurse aide education program.

2. Supplies. Cost of supplies of textbooks and other required course materials provided during the nurse aide education programs by the nursing facility.

3. License fees. Cost of nurse aide registry application fees and competency evaluation testing fee paid by the nursing facility on behalf of the certified nurse aides.

4. Travel. Cost for transportation provided to the nurse aides to the training or competency evaluation testing site.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia and Item 322(D)(2a) of Chapter 912 of the 1996 Acts of Assembly.
• Historical Notes: Derived from Virginia Register Volume 14, Issue 1, eff. December 1, 1997.

12VAC30-90-276 Criminal records background checks

Included in the Uniform Expense Classifications is the cost of obtaining criminal records checks from the Central Criminal Records Exchange for all persons hired for compensated employment after July 1, 1993.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia and Item 322(D)(2a) of Chapter 912 of the 1996 Acts of Assembly.
• Historical Notes: Derived from Virginia Register Volume 14, Issue 1, eff. December 1, 1997.

12VAC30-90-280 Leasing of facilities

Appendix II Leasing of Facilities

The substance of this appendix shall apply only to Article 2 (12VAC30-90-30 et seq.) of Subpart II of Part II of this chapter.

I. DETERMINATION OF ALLOWABLE LEASE COSTS.

A. The provisions of this appendix shall apply to all lease agreements, including sales and leaseback agreements and lease purchase agreements, and including whether or not such agreements are between parties which are related (as defined in 12VAC30-90-50 of the Nursing Home Payment System (NHPS)).

B. Reimbursement of lease costs pursuant to a lease between parties which are not related shall be limited to the DMAS allowable cost of ownership as determined in subsection I E of this section. Reimbursement of lease costs pursuant to a lease between parties which are related (as defined in 12VAC30-90-50) shall be adjusted to the DMAS allowable cost of ownership. Whether the lease is between parties which are or are not related, the computation of the allowable annual lease expense shall be subject to DMAS audit.

C. The DMAS allowable cost of ownership shall be determined by the historical cost of the facility to the owner of record at the date the lease becomes effective. When a lease agreement is in effect, whether during the original term or a subsequent renewal, no increase in the reimbursement shall be allowed as a result of a subsequent sale of the facility.

D. When a bona fide sale has taken place, the facility must have been held by the seller for a period of no less than five years for a lease effected subsequent to the sale date to be compared to the buyer's cost of ownership. Where the facility has been held for less than five years, the allowable lease cost shall be computed using the seller's historical cost.

E. Reimbursement of lease costs pursuant to a lease between parties which are not related (as defined in 12VAC30-90-50) shall be limited to the DMAS allowable cost of ownership. The following reimbursement principles shall apply to leases, other than those covered in 12VAC30-90-50 and subsection IV of this appendix, entered into on or after October 1, 1990:

1. An "Allowable Cost of Ownership" schedule shall be created for the lease period to compare the total lease expense to the allowable cost of ownership.

2. If the lease cost for any cost reporting period is below the cost of ownership for that period, no adjustment shall be made to the lease cost, and a "carryover credit" to the extent of the amount allowable for that period under the "Allowable Cost of Ownership" schedule shall be created but not paid.

3. If the lease cost for a future cost reporting period is greater than the "Cost of Ownership" for that period, the provider shall be paid this "carryover credit" from prior period(s), not to exceed the cumulative carryover credit or his actual lease cost, whichever is less. At no time during the lease period shall DMAS reimbursement exceed the actual cumulative "Cost of Ownership."

4. Once DMAS has determined the allowable cost of ownership, the provider shall be responsible for preparing a verifiable and auditable schedule to support cumulative computations of cost of ownership vs. lease cost to support the "carryover credit" as reported in the "Allowable Cost of Ownership" schedule, and shall submit such a schedule with each cost report.

II. DOCUMENTATION OF COSTS OF OWNERSHIP.

A. Leases shall provide that the lessee or DMAS shall have access to any and all documents required to establish the underlying cost of ownership.

B. In those instances where the lessor will not share this information with the lessee, the lessor can forward this information direct to DMAS for confidential review.

III. COMPUTATION OF COST OF OWNERSHIP.

A. Before any rate determination for allowable lease costs is made, the lessee must supply a schedule comparing lease expense to the underlying cost of ownership for the life of the lease. Supporting documentation, including but not limited to, the lease and the actual cost of ownership (mortgage instruments, financial statements, purchase agreements, etc.) must be included with this schedule.

B. The underlying straight-line depreciation, interest, property taxes, insurance, and amortization of legal and commitment fees shall be used to determine the cost of ownership for comparison to the lease costs. Any cost associated with the acquisition of a lease other than those outlined herein shall not be considered allowable unless specifically approved by the Department of Medical Assistance Services.

1. Straight line depreciation.

a. Depreciation shall be computed on a straight line basis only.

b. New or additions facilities shall be depreciated in accordance with AHA Guidelines.

c. Allowable depreciation for on-going facilities shall be computed on the historical cost of the facility determined in accordance with limits on allowable building and fixed equipment cost.

d. The limits contained in 12VAC30-90-30, and Part VI (12VAC30-90-160) shall apply, as appropriate, whether the facility is newly constructed or an on-going facility.

2. Interest. Interest expense shall be limited to actual expense incurred by the owner of the facility in servicing long-term debt and shall be subject to the interest rate limitations stated in 12VAC30-90-30.

3. Taxes and insurance. Taxes are limited to actual incurred real estate and property taxes. Insurance is limited to the actual cost of mortgage insurance, fire and property liability insurance. When included in the lease as the direct responsibility of the lessee, such taxes and insurance shall not be a part of the computation of the cost of ownership.

4. Legal and commitment fees. Amortization of actual incurred closing costs paid by the owner, such as attorney's fees, recording fees, transfer taxes and service or "finance" charges from the lending institution may be included in the comparison of the cost of ownership computation. Such fees shall be subject to limitations and tests of reasonableness stated in these regulations. These costs shall be amortized over the life of the mortgage.

5. Return on Equity.

a. Return on equity will be limited to the equity of the facility's owner when determining allowable lease expense. Return on equity shall be equal to the rental rate percentage used in connection with the fair rental value (FRV) methodology described in Article 3 (12VAC30-90-35 et seq.) of Subpart II of Part II of this chapter. For the purpose of determining allowable lease expense, equity will be computed in accordance with PRM-15 principles. The allowable base will be determined by monthly averaging of the annual equity balances. The base will be increased by the amount of paid up principal in a period but will be reduced by depreciation expense in that period.

b. Item 398D of the 1987 Appropriations Act (as amended), effective April 8, 1987 eliminated reimbursement of return on equity capital to proprietary providers for periods or portions thereof on or after July 1, 1987.

c. Leased facilities shall be eligible for return on equity capital after July 1, 2001, only if they were receiving return on equity capital on June 30, 2000.

IV. LEASES APPROVED PRIOR TO AUGUST 18, 1975.

A. Leases approved prior to August 18, 1975, shall have the terms of those leases honored for reimbursement throughout the duration of the lease.

B. Renewals and extensions to these leases shall be honored for reimbursement purposes only when the dollar amount negotiated at the time of renewal does not exceed the amount in effect at the termination date of the existing lease. No escalation clauses shall be approved.

C. Payments of rental costs for leases reimbursed pursuant to subsection IV A of this section shall be allowed whether the provider occupies the premises as a lessee, sublessee, assignee, or otherwise. Regardless of the terms of any present or future document creating a provider's tenancy or right of possession, and regardless of whether the terms thereof or the parties thereto may change from time to time, future reimbursement shall be limited to the lesser of (i) the amount actually paid by the provider, or (ii) the amount reimbursable by DMAS under these regulations as of July 1, 2002. In the event extensions or renewals are approved pursuant to subsection IV B of this section, no escalation clauses shall be approved or honored for reimbursement purposes.

V. NOTHING IN THIS APPENDIX SHALL BE CONSTRUED AS ASSURING PROVIDERS THAT REIMBURSEMENT FOR RENTAL COSTS WILL CONTINUE TO BE REIMBURSABLE UNDER ANY FURTHER REVISIONS OF OR AMENDMENT TO THESE REGULATIONS.

History

• Statutory Authority: § 31.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-03-4.1942:1, eff. October 1, 1990; amended, Virginia Register Volume 17, Issue 18, eff. July 1, 2001; Volume 18, Issue 18, eff. July 1, 2002.

12VAC30-90-290 Cost reimbursement limitations

Appendix III Cost Reimbursement Limitations

A. This appendix outlines operating, NATCEPs and plant cost limitations that are not referenced in previous sections of these regulations. All of the operating cost limitations are further subject to the applicable operating ceilings.

B. Directors' fees.

1. Although Medicaid does not require a board of directors (Medicare requires only an annual stockholders' meeting), the Program will recognize reasonable costs for directors' meetings related to patient care.

2. It is not the intent of DMAS to reimburse a facility for the conduct of business related to owner's investments, nor is it the intent of the Program to recognize such costs in a closely held corporation where one person owns all stock, maintains all control, and approves all decisions.

3. To receive reimbursement for directors' meetings, the written minutes must reflect the name of the facility for which the meeting is called, the content and purpose of the meeting, members in attendance, the time the meeting began and ended, and the date. If multiple facilities are discussed during a meeting, total allowable director fees, as limited herein, shall be pro-rated between such facilities.

4. Bona fide directors may be paid an hourly rate of $125 up to a maximum of four hours per month. These fees include reimbursement for time, travel, and services performed.

5. Compensation to owner/administrators who also serve as directors shall include any director's fees paid, subject to the above referenced limit set forth in these regulations.

C. Membership fees.

1. These allowable costs will be restricted to membership in health care organizations and appropriate professional societies which promote objectives in the provider's field of health care activities.

2. Membership fees in health care organizations and appropriate professional societies will be allowed for the administrator, owner, and home office personnel.

3. Comparisons will be made with other providers to determine reasonableness of the number of organizations to which the provider will be reimbursed for such membership and the claimed costs, if deemed necessary.

D. Management fees.

1. External management services shall only be reimbursed if they are necessary, cost effective, and nonduplicative of existing nursing facility internal management services.

2. Costs to the provider, based upon a percentage of net and/or gross revenues or other variations thereof, shall not be an acceptable basis for reimbursement. If allowed, management fees must be reasonable and based upon rates related to services provided.

3. Management fees paid to a related party may be recognized by the Program as the owner's compensation subject to administrator compensation guidelines.

4. A management fees service agreements exists when the contractor provides nonduplicative personnel, equipment, services, and supervision.

5. A consulting service agreement exists when the contractor provides nonduplicative supervisory or management services only.

6. Limits will be based upon comparisons with other similar size facilities and/or other DMAS guidelines and information.

Effective for all providers' cost reporting periods ending on or after October 1, 1990, a per patient day ceiling for all full service management service costs shall be established. The ceiling limitation for cost reporting periods ending on or after October 1, 1990, through December 31, 1990, shall be the median per patient day cost as determined from information contained in the most recent cost reports for all providers with fiscal years ending through December 31, 1989. These limits will be adjusted annually by a Consumer Price Index effective January 1 of each calendar year to be effective for all providers' cost reporting periods ending on or after that date. The limits will be published and distributed to providers annually. Effective July 1, 2006, these limits apply only to related parties.

E. Pharmacy consultants fees. Costs will be allowed to the extent they are reasonable and necessary.

F. Physical therapy fees (for outside services). Limits are based upon current PRM-15 guidelines.

G. Inhalation therapy fees (for outside services). Limits are based upon current PRM-15 guidelines.

H. Medical directors' fees. Costs will be allowed up to the established limit per year to the extent that such fees are determined to be reasonable and proper. This limit will be escalated annually by the CPI-U January 1 of each calendar year to be effective for all providers' cost reporting periods ending on or after that date. The limits will be published and distributed to providers annually. Effective July 1, 2006, these limits apply only to related parties. The following limitations apply to the time periods as indicated:

| | Jan. 1, 1988 -- Dec. 31, 1988 | $6,204 | | --- | --- | --- | | | Jan. 1, 1989 -- Dec. 31, 1989 | $6,625 |

I. Reimbursement for physical therapy, occupational therapy, and speech-language therapy services shall not be provided for any sums that the rehabilitation provider collects, or is entitled to collect, from the nursing facility or any other available source, and provided further, that this amendment shall in no way diminish any obligation of the nursing facility to DMAS to provide its residents such services, as set forth in any applicable provider agreement.

J. Personal automobile.

1. Use of personal automobiles when related to patient care will be reimbursed at the maximum of the allowable IRS mileage rate when travel is documented.

2. Flat rates for use of personal automobiles will not be reimbursed.

K. Seminar expenses.

These expenses will be treated as allowable costs, if the following criteria are met:

1. Seminar must be related to patient care activities, rather than promoting the interest of the owner or organization.

2. Expenses must be supported by:

a. Seminar brochure,

b. Receipts for room, board, travel, registration, and educational material.

3. Only the cost of two persons per facility will be accepted as an allowable cost for seminars which involve room, board, and travel.

L. Legal retainer fees. DMAS will recognize legal retainer fees if such fees do not exceed the following:

| BED SIZE | LIMITATIONS | | --- | --- | | 0 - 50 | $100 per month | | 51 - 100 | $150 per month | | 101 - 200 | $200 per month | | 201 - 300 | $300 per month | | 301 - 400 | $400 per month |

The expense to be allowed by DMAS shall be supported by an invoice and evidence of payment.

M. Architect fees. Architect fees will be limited to the amounts and standards as published by the Virginia Department of General Services.

N. Administrator/owner compensation.

| DMAS ADMINISTRATOR/OWNER COMPENSATION SCHEDULE JANUARY 1, 1989 -- DECEMBER 31, 1989 | | | | --- | --- | --- | | BED SIZE | NORMAL ALLOWABLE FOR ONE ADMINISTRATOR | MAXIMUM FOR 2 OR MORE ADMINISTRATORS | | 1 - 75 | 32,708 | 49,063 | | 76 - 100 | 35,470 | 53,201 | | 101 - 125 | 40,788 | 61,181 | | 126 - 150 | 46,107 | 69,160 | | 151 - 175 | 51,623 | 77,436 | | 176 - 200 | 56,946 | 85,415 | | 201 - 225 | 60,936 | 91,399 | | 226 - 250 | 64,924 | 97,388 | | 251 - 275 | 68,915 | 103,370 | | 276 - 300 | 72,906 | 108,375 | | 301 - 325 | 76,894 | 115,344 | | 326 - 350 | 80,885 | 121,330 | | 351 - 375 | 84,929 | 127,394 | | 376 & over | 89,175 | 133,763 |

These limits will be escalated annually by the CPI-U effective January 1 of each calendar year to be effective for all providers' cost reporting periods ending on or after that date. The limits will be published and distributed to providers annually. Effective July 1, 2006, these limits apply only to related parties.

O. Kinetic therapy. For specialized care reimbursement effective December 1, 1996, a limitation per patient day on kinetic therapy shall be established based on historical data. This limit shall be reviewed annually by January 1 of each calendar year and compared to actual cost data, then revised if appropriate, to be effective for all providers' cost reporting periods ending on or after that date. The limit will be published and distributed to providers annually. It shall be:

| | December 1, 1996 -- December 31, 1997 | $102 per day | | --- | --- | --- |

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-03-4.1943:1 §§ 1.1 through 1.7, eff. October 1, 1990; amended, Virginia Register Volume 12, Issue 5, eff. November 29, 1995; Volume 14, Issue 1, eff. December 1, 1997; Volume 23, Issue 20, eff. August 25, 2007.

12VAC30-90-300 (Repealed.)

Historical Notes

Derived from VR460-03-4.1944:1 §§ 1.1 through 1.6, eff. August 12, 1992; amended, Virginia Register Volume 14, Issue 1, eff. December 1, 1997 repealed, Virginia Register Volume 18, Issue 18, eff. July 1, 2002.

12VAC30-90-305 Resource Utilization Groups (RUGs)

Appendix IV Resource Utilization Groups (RUGs)

A. The Resource Utilization Groups-III (RUG-III), Version 5.12, 34-group, index maximizing model shall be used as the resident classification system to determine the RUG-III group for each resident assessment. RUG-III classifies resident assessments according to the intensity of each resident's needs. Data from the minimum data set (MDS) submitted by each facility to the Centers for Medicare and Medicaid Services (CMS) shall be used to classify the resident assessments into RUG-III groups.

B. Definitions. The following words and terms when used in this appendix shall have the following meanings unless the context clearly indicates otherwise.

"Base year" means the calendar year for which the most recent reliable nursing facility cost settled cost reports are available in the DMAS database as of September 1 of the year prior to the year in which the rebased rates will be used. (See also definition of rebasing.)

"Case-mix index (CMI)" means a numeric score that identifies the relative resources used by similar residents and represents the average resource consumption of those residents.

"Case-mix neutralization" means the process of removing cost variations for direct patient care costs associated with different levels of resident case mix.

"Day-weighted median" means a weighted median where the weight is Medicaid days.

"Medicaid average case-mix index" means a simple average, carried to four decimal places, of all resident case mix indices where Medicaid is known to be the per diem payor source on the last day of the calendar quarter.

"Minimum data set (MDS)" means a federally required resident assessment instrument. Information from the MDS is used to determine the facility's case-mix index.

"Normalization" means the process by which the average case mix for the state is set to 1.0.

"Nursing facility" means a facility, not including intermediate care facilities for the mentally retarded, licensed by the Department of Health and certified as meeting the participation requirements of the Medicaid program.

"Rebasing" means the process of updating cost data used to calculate peer group ceilings for subsequent base years.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. July 1, 2002.

12VAC30-90-306 Case-mix index (CMI)

A. Effective for dates of service beginning July 1, 2001, through June 30, 2014, nursing facility case-mix indices shall be applied as described in this subsection. Each resident in a Virginia Medicaid certified nursing facility on the last day of the calendar quarter with an effective assessment date during the respective quarter shall be assigned to one of the RUG-III 34 groups.

B. Effective for dates of service on or after July 1, 2014, nursing facility reimbursement described in 12VAC30-90-44 shall be based on the case-mix or RUG weights as described in this subsection. Standard case-mix indices, developed by CMS for the Medicaid population (B01), shall be assigned to each of the RUG-III 34 groups as indicated in Table III.

| Table III Case-Mix Indices (CMI) | | | | --- | --- | --- | | RUG Category | RUG Description | CMS "Standard" B01 CMI Set | | RAD | Rehabilitation All Levels / ADL 17-18 | 1.66 | | RAC | Rehabilitation All Levels / ADL 14-16 | 1.31 | | RAB | Rehabilitation All Levels / ADL 10-13 | 1.24 | | RAA | Rehabilitation All Levels / ADL 4-9 | 1.07 | | SE3 | Extensive Special Care 3 / ADL >6 | 2.10 | | SE2 | Extensive Special Care 2 / ADL >6 | 1.79 | | SE1 | Extensive Special Care 1 / ADL >6 | 1.54 | | SSC | Special Care / ADL 17-18 | 1.44 | | SSB | Special Care / ADL 15-16 | 1.33 | | SSA | Special Care / ADL 4-14 | 1.28 | | CC2 | Clinically Complex with Depression / ADL 17-18 | 1.42 | | CC1 | Clinically Complex / ADL 17-18 | 1.25 | | CB2 | Clinically Complex with Depression / ADL 12-16 | 1.15 | | CB1 | Clinically Complex / ADL 12-16 | 1.07 | | CA2 | Clinically Complex with Depression / ADL 4-11 | 1.06 | | CA1 | Clinically Complex / ADL 4-11 | 0.95 | | IB2 | Cognitive Impairment with Nursing Rehab / ADL 6-10 | 0.88 | | IB1 | Cognitive Impairment / ADL 6-10 | 0.85 | | IA2 | Cognitive Impairment with Nursing Rehab / ADL 4-5 | 0.72 | | IA1 | Cognitive Impairment / ADL 4-5 | 0.67 | | BB2 | Behavior Problem with Nursing Rehab / ADL 6-10 | 0.86 | | BB1 | Behavior Problem / ADL 6-10 | 0.82 | | BA2 | Behavior Problem with Nursing Rehab / ADL 4-5 | 0.71 | | BA1 | Behavior Problem / ADL 4-5 | 0.60 | | PE2 | Physical Function with Nursing Rehab / ADL 16-18 | 1.00 | | PE1 | Physical Function / ADL 16-18 | 0.97 | | PD2 | Physical Function with Nursing Rehab / ADL 11-15 | 0.91 | | PD1 | Physical Function / ADL 11-15 | 0.89 | | PC2 | Physical Function with Nursing Rehab / ADL 9-10 | 0.83 | | PC1 | Physical Function / ADL 9-10 | 0.81 | | PB2 | Physical Function with Nursing Rehab / ADL 6-8 | 0.65 | | PB1 | Physical Function / ADL 6-8 | 0.63 | | PA2 | Physical Function with Nursing Rehab / ADL 4-5 | 0.62 | | PA1 | Physical Function / ADL 4-5 | 0.59 |

C. There shall be four "picture dates" for each calendar year: March 31, June 30, September 30 and December 31. Each resident in each Medicaid-certified nursing facility on the picture date with a completed assessment that has an effective assessment date within the quarter shall be assigned a case-mix index based on the resident's most recent assessment for the picture date as available in the DMAS MDS database.

D. Using the individual Medicaid resident case-mix indices, a facility average Medicaid case-mix index shall be calculated four times per year for each facility. The facility average Medicaid case-mix indices shall be used for case-mix neutralization of resident care costs and for case-mix adjustment.

1. During the time period beginning with the implementation of RUG-III up to the ceiling and rate setting effective July 1, 2004, the case-mix index calculations shall be based on assessments for residents for whom Medicaid is the principal payer. The statewide average Medicaid case-mix index shall be a simple average, carried to four decimal places, of all case-mix indices for nursing facility residents in Virginia Medicaid certified nursing facilities for whom Medicaid is the principal payer on the last day of the calendar quarter. The facility average Medicaid case-mix index shall be a simple average, carried to four decimal places, of all case-mix indices for nursing facility residents in the Virginia Medicaid-certified nursing facility for whom Medicaid is the principal payer on the last day of the calendar quarter.

2. The facility average Medicaid case-mix index shall be normalized across all of Virginia's Medicaid-certified nursing facilities for each picture date. To normalize the facility average Medicaid case-mix index, the facility average Medicaid case-mix index is divided by the statewide average Medicaid case-mix index for the same picture date.

3. The department shall monitor the case-mix, including the case-mix normalization and the neutralization processes, indices during the first two years following implementation of the RUG-III system. Effective July 1, 2004, the statewide average case-mix index may be changed to recognize the fact that the costs of all residents are related to the case-mix of all residents. The statewide average case-mix index of all residents, regardless of principal payer on the effective date of the assessment, in a Virginia Medicaid certified nursing facility may be used for case-mix neutralization. The use of the facility average Medicaid case-mix index to adjust the prospective rate would not change.

4. There shall be a correction period for Medicaid-certified nursing facilities to submit correction assessments to the CMS MDS database following each picture date. A report that details the picture date RUG category and CMI score for each resident in each nursing facility shall be mailed to the facility for review. The nursing facility shall have a 30-day time period to submit any correction assessments to the MDS database or to contact the Department of Medical Assistance Services regarding other corrections. Corrections submitted in the 30-day timeframe shall be included in the final report of the CMI scores that shall be used in the calculation of the nursing facility ceilings and rates. Any corrections submitted after the 30-day timeframe shall not be included in the final report of the CMI scores that shall be used in the calculation of the nursing facility ceilings and rates.

5. Assessments that cannot be classified to a RUG-III group due to errors shall be assigned the lowest case-mix index score.

6. Assessments shall not be used for any out-of-state nursing facility provider that is enrolled in the Virginia Medical Assistance Program and is required to submit cost reports to the Medicaid program.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. July 1, 2002; Errata, 18:20 VA.R. 2681 June 17, 2002; amended, Virginia Register Volume 32, Issue 9, eff. February 11, 2016.

12VAC30-90-307 Applicability of case-mix indices (CMI)

A. The CMI shall be used to adjust the direct patient care cost ceilings and rates for application to individual nursing facilities. Indirect patient care cost ceilings and rates shall not be case-mix adjusted. The CMI shall be calculated using MDS data taken from picture dates as specified in this section.

B. When a facility's direct patient care cost ceiling is compared to its facility specific direct patient care cost rate to determine the direct patient care prospective rate, both the ceiling and the rate shall be case-mix neutral. The direct patient care cost ceiling shall be case-mix neutral because it shall be calculated using base year facility direct patient care cost data that have been case-mix neutralized. To accomplish this neutralization, each facility's base year direct patient care operating cost shall be divided by the facility's average normalized Medicaid CMI developed for the two semiannual periods of assessment data that most closely match the provider's cost reporting year that ends in the base year (see Table IV below). This shall be the facility's case-mix neutral direct patient care per diem for the base year and shall be used in the calculation of the peer group direct patient care cost ceilings. Table IV shows an example of the picture dates used to case-mix neutralize facility specific direct costs for the ceiling calculation. For the first few provider fiscal years for which cost neutralization will be done, a data limitation affects the picture dates that can be used. Accurate case-mix data are available starting with the fourth quarter of calendar year (CY) 1999. For providers with cost reporting periods ending during the first, second, and third quarters of CY 2000, the picture dates used in cost neutralization shall be modified to reflect only accurate case-mix data. For provider cost reporting periods ending in the fourth quarter of 2000 and afterward, this limitation no longer exists and assessment data shall be used that most closely match the cost reporting period.

| Table IV | | | | --- | --- | --- | | Quarter of Provider Cost Report Year End | Picture Dates Used to Neutralize Costs for Ceiling Calculation | | | | Preferred Picture Dates if No Data Limitation Applied | Picture Dates That Shall be Used Due to Data Limitation | | First Quarter of CY 2000 | 3/31/99, 6/30/99, 9/30/99, 12/31/99 | 12/31/99 | | Second Quarter of CY 2000 | 6/30/99, 9/30/99, 12/31/99, 3/31/00 | 12/31/99, 3/31/00 | | Third Quarter of CY 2000 | 9/30/99, 12/31/99, 3/31/00, 6/30/00 | 12/31/99, 3/31/00, 6/30/00 | | Fourth Quarter of CY 2000 | 12/31/99, 3/31/00, 6/30/00, 9/30/00 | 12/31/99, 3/31/00, 6/30/00, 9/30/00 |

C. When direct patient care prospective rates are set, the direct patient care ceilings used in the calculation shall be the case-mix neutralized ceiling described in subsection B of this section, adjusted for inflation to the midpoint of the prospective period. However, the facility-specific direct patient care cost rates used in the calculation shall not be from the base year, but shall be from the provider fiscal year prior to the period for which a prospective rate is being calculated. Therefore, the provider's direct patient care rate from the previous cost reporting period shall be case-mix neutralized using the facility average normalized Medicaid CMI developed for the two semiannual periods of assessment data that most closely match the cost reporting period prior to the prospective period for which a rate is being calculated. Each year when a new prospective rate is developed, the provider specific direct patient care rate shall be case-mix neutralized using CMI data that uses picture dates that correspond to the cost reporting period used to develop the rate. The relationship between provider cost reporting period and picture dates shall be that illustrated in Table IV, except that in the time period when rates will first be set, the data limitation that affected the picture dates shown in Table IV will not apply. Therefore, for all provider cost reporting periods, picture dates that correspond to the cost reporting period shall be used.

D. After the case-mix neutral direct patient care ceiling (adjusted for inflation from the base year to the prospective period) is compared to the case-mix neutralized facility-specific direct patient care rate (adjusted for inflation from the previous cost reporting period to the prospective period), the lower of the two shall be chosen. This lower amount shall be the case-mix neutral prospective rate per diem for the prospective period. It shall then be adjusted for the CMI intended to correspond as closely as possible to the prospective period. Because of the manner in which the necessary data are reported, there shall be a lag between the picture dates used to develop the CMI information and the prospective period to which the CMI shall apply. The relationship between picture dates and prospective rate periods is illustrated in Table V.

| Table V Example of Picture Dates Used in Case-Mix Adjustment of Prospective Rate | | | | --- | --- | --- | | Quarter of Provider Cost Report Year End | Picture Dates Used to Adjust First Prospective Semiannual Period | Picture Dates Used to Adjust Second Prospective Semiannual Period | | First Quarter CY 2002 | 9/30/01, 12/31/01 | 3/31/02, 6/30/02 | | Second Quarter CY 2002 | 12/31/01, 3/31/02 | 6/30/02, 9/30/02 | | Third Quarter CY 2002 | 3/31/02, 6/30/02 | 9/30/02, 12/31/02 | | Fourth Quarter CY 2002 | 6/30/02, 9/30/02 | 12/31/02, 3/31/03 |

E. Any out-of-state nursing facility provider that is enrolled in the Virginia Medical Assistance Program and is required to submit a cost report to the Virginia Medical Assistance Program will be assigned the Virginia statewide normalized CMI of 1.0. This CMI of 1.0 will be used to adjust the direct patient care cost ceilings and rates.

F. Example of case-mix adjustment of direct operating rate.

1. Following is an illustration of how a nursing facility's case-mix index is used to make direct patient care semiannual rate adjustments to the prospective direct patient care operating cost base rate.

2. Assumptions.

a. The nursing facility's fiscal year is January 1, 2002, through December 31, 2002.

b. The average allowable direct patient care operating rate for the year is $50.

c. The allowance for inflation is 4.0% for the fiscal year beginning January 1, 2003.

d. The nursing facility's case-mix neutral direct peer group ceiling for the fiscal year beginning January 1, 2003, is $60.

e. The nursing facility's normalized case-mix scores are as follows:

| | 12/31/2001 picture date CMI | 1.0100 | | --- | --- | --- | | | 3/31/2002 picture date CMI | 1.0105 | | | 6/30/2002 picture date CMI | 1.0098 | | | 9/30/2002 picture date CMI | 1.0305 | | | 12/31/2002 picture date CMI | 1.0355 | | | 3/31/2003 picture date CMI | 1.0400 |

3. Calculation of nursing facility's Direct Patient Care Operating Cost Rate.

a. Direct Patient Care Operating Cost Rate:

| | Average Allowable Direct Patient Care Operating Rate | $50 | | --- | --- | --- | | | Allowance For Inflation FYE 2003 x 1.0400 | $52 |

b. Calculation of case-mix factor used for case-mix neutralization:

| | 12/31/2001 CMI | 1.0100 | | --- | --- | --- | | | 3/31/2002 CMI | 1.0105 | | | 6/30/2002 CMI | 1.0098 | | | 9/30/2002 CMI | 1.0305 | | | Average of four CMI = | 1.0152 |

c. Case-mix neutralized average allowable direct patient care operating rate: Average Allowable Direct Patient Care Operating Rate for FY 2003 $52

Case-mix neutralization factor ÷ 1.0152

Case-mix neutralized Direct Patient Care Operating Rate for FY 2003 = $51.22

d. Lower of case-mix neutralized cost or ceiling:

The case-mix neutralized Direct Patient Care Operating Rate, $51.22, is lower than the case-mix neutral ceiling, $60. $51.22 will be used in the rate calculation.

e. Calculation of case-mix rate adjustments:

(1) Case-mix rate adjustment for the period January 1, 2003, through June 30, 2003:

First semiannual rate adjustment %68 Average of (6/30/2002 CMI, 9/30/2002 CMI) = Average(1.0098,1.0305) = 1.0202

(2) Case-mix rate adjustment for the period July 1, 2003 through December 31, 2003:

Second semiannual rate adjustment %68 Average of (12/31/2002 CMI, 3/31/2003 CMI) = Average(1.0355,1.0400) =1.0378

f. Rates for semiannual periods:

(1) Case-mix adjusted rate for the period January 1, 2003, through June 30, 2003:

First semiannual rate = 1.0202 * $51.22 = $52.25

(2) Case-mix adjusted rate for the period July 1, 2003 through December 31, 2003:

Second semiannual rate = 1.0378 * $51.22 = $53.15

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. July 1, 2002.

12VAC30-90-310 Normalized Case Mix Index (NCMI)

Appendix V Normalized Case Mix Index

A. This appendix illustrates how a specialized care provider's Normalized Case Mix Index (NCMI) is used to adjust the prospective routine operating cost base rate and prospective operating ceiling.

B. Assumptions.

1. The nursing facility's fiscal years are December 31, 1996, and December 31, 1997.

2. The average allowable routine nursing labor and nonlabor base rate for December 31, 1996, is $205.

3. The average allowable indirect patient care operating base rate for December 31, 1996, is $90.

4. The allowance for inflation is 3.0% for the fiscal year end beginning January 1, 1997.

5. The nursing facility's statewide ceiling for the fiscal year end beginning January 1, 1997, is $300.

6. The nursing facility's normalized HCFA nursing wage index is 1.0941 for the fiscal year end beginning January 1, 1997.

7. The nursing facility's semiannual normalized NCMIs are as follows:

| | 1996 First semiannual NCMI | 1.2000 | | --- | --- | --- | | | 1996 Second semiannual NCMI | 1.2400 | | | 1997 First semiannual NCMI | 1.2600 |

C. Calculation of nursing facility's operating ceiling.

1. Period January 1, 1997, through June 30, 1997.

| | FYE 1997 Statewide Ceiling | | $300 | | --- | --- | --- | --- | | | Nursing Labor Component Percentage | x 67.22% | = $201.66 | | | Normalized Wage Index | x 1.0941 | | | | Adjusted Nursing Labor Ceiling Component | | = $220.64 | | | Nursing Nonlabor Ceiling Component | | + $11.49 | | | Adjusted Nursing Labor and Nonlabor Ceiling | | = $232.13 | | | FYE 1996 Second semiannual NCMI | x 1.2400 | = $287.84 | | | Indirect Patient Care Ceiling Component | ($300.00 - 201.66 - 11.49) | = $86.85 | | | Total Facility Operating Ceiling | $287.84 | = $374.69 |

2. Period July 1, 1997, through December 31, 1997.

| | Adjusted Nursing Labor and Nonlabor Ceiling per subdivision 1 of this subsection | | $232.13 | | --- | --- | --- | --- | | | FYE 1997 First semiannual NCMI | x 1.2600 | = $292.48 | | | Indirect Patient Care Ceiling Component | + 86.85 | | | | Total Facility Operating Ceiling | | = $379.33 |

D. Calculation of nursing facility's prospective operating cost rate.

1. Prospective operating cost base rate.

| | FYE 1996 Nursing Labor and Nonlabor Operating Base Rate | | $205 | | --- | --- | --- | --- | | | Allowance for Inflation - FYE 1997 | x 1.03 | | | | Prospective Nursing Labor and Nonlabor Cost Rate | | = $211.15 | | | FYE 1996 Indirect Patient Care Operating Base Rate | | $90.00 | | | Allowance for Inflation - FYE 1997 | x 1.03 | | | | Prospective Indirect Patient Care Operating Cost Rate | | = $92.70 |

2. Calculation of FYE 1996 Average NCMI.

| | First semiannual Period NCMI | 1.2000 | | --- | --- | --- | | | Second semiannual Period NCMI | 1.2400 | | | Average FYE 1996 NCMI | 1.2200 |

3. Calculation of FYE 1997 NCMI Rate Adjustments.

a. Rate adjustment for the period January 1, 1997, through June 30, 1997.

| | 1996 Second semiannual NCMI | | 1.2400 | | --- | --- | --- | --- | | | 1996 Average NCMI (from subdivision 2 of this subsection | | 1.2200 | | | Calculation: | 1.2400/1.2200 | | | | Rate Adjustment Factor | = 1.0164 | | | | Prospective Nursing Labor and Nonlabor Operating Cost Base Rate (from subdivision 1 of this subsection) | | $211.15 | | | | x 1.0164 | = $214.61 | | | Prospective Indirect Patient Care Operating Cost Rate (from subdivision 1 of this subsection) | + $92.70 | | | | Total Prospective Operating Cost Rate | | = $307.31 |

b. Rate Adjustment for the Period July 1, 1997, through December 31, 1997.

| | 1997 First semiannual NCMI | | 1.2600 | | --- | --- | --- | --- | | | 1996 Average NCMI (from subdivision 2 of this subsection) | | 1.2200 | | | Calculation: | 1.2600/1.2200 | | | | Rate Adjustment Factor | | = 1.0328 | | | Prospective Nursing Labor and Nonlabor Operating Cost Rate (from subdivision 1 of this subsection) | | $211.15 | | | Rate Adjustment Factor | x 1.0328 | | | | Prospective Indirect Patient Care Operating Cost Rate (from subdivision 1 of this subsection) | $ 92.70 | | | | Total Prospective Operating Cost Rate | | = $310.78 |

D. In this illustration the nursing facility's operating reimbursement rate for FYE 1997 would be as follows:

1. For the period January 1, 1997, through June 30, 1997, the operating reimbursement rate would be $307.31 since the prospective operating cost rate is lower than the nursing facility's NCMI adjusted ceiling of $374.69 (from subdivision C 1 of this section).

2. For the period July 1, 1997, through December 31, 1997, the operating reimbursement rate would be $310.78 since the prospective operating cost rate is lower than the nursing facility's NCMI adjusted ceiling of $379.33 (from subdivision C 2 of this section).

History

• Statutory Authority: § 32.1-325 of the Code of Virginia and Item 322(D)(2a) of Chapter 912 of the 1996 Acts of Assembly.
• Historical Notes: Derived from Virginia Register Volume 14, Issue 1, eff. December 1, 1997.

12VAC30-90-320 National RUG-III categories and weights

Appendix VI National RUG-III Categories and Weights

| RUG III Group Name | RUG Group Code | Nursing Only Weight | | --- | --- | --- | | Rehabilitation | RVC | 1.79 | | | RVB | 1.18 | | | RVA | 0.82 | | | RHD | 1.93 | | | RHC | 1.50 | | | RHB | 1.31 | | | RHA | 1.06 | | | RMC | 2.09 | | | RMB | 1.38 | | | RMA | 1.25 | | | RLB | 1.36 | | | RLA | 1.14 | | Extensive Services | SE3 | 3.97 | | | SE2 | 2.65 | | | SE1 | 1.78 | | Special Care | SSC | 1.61 | | | SSB | 1.47 | | | SSA | 1.28 | | Clinically Complex | CD2 | 1.46 | | | CD1 | 1.37 | | | CC2 | 1.19 | | | CC1 | 1.16 | | | CB2 | 1.08 | | | CB1 | 0.94 | | | CA2 | 0.76 | | | CA1 | 0.67 | | Impaired Cognition | IB2 | 0.88 | | | IB1 | 0.80 | | | IA2 | 0.60 | | | IA1 | 0.49 | | Behavior Problems | BB2 | 0.87 | | | BB1 | 0.78 | | | BA2 | 0.58 | | | BA1 | 0.41 | | Physical Functions | PE2 | 1.19 | | | PE1 | 1.13 | | | PD2 | 1.01 | | | PD1 | 1.00 | | | PC2 | 0.86 | | | PC1 | 0.77 | | | PB2 | 0.68 | | | PB1 | 0.66 | | | PA2 | 0.52 | | | PA1 | 0.39 |

History

• Statutory Authority: § 32.1-325 of the Code of Virginia and Item 322(D)(2a) of Chapter 912 of the 1996 Acts of Assembly.
• Historical Notes: Derived from Virginia Register Volume 14, Issue 1, eff. December 1, 1997.

12VAC30-90-330 Traumatic brain injury diagnoses

A. Consistent with the Nursing Home Payment System, DMAS shall provide a fixed per day payment for nursing facility residents with traumatic brain injury diagnoses. The residents and facilities must meet the criteria set out in this section.

B. Resident criteria. To meet the criteria for admission and continued stay for the TBI program, there shall be documented evidence in the resident's medical record of all of the following:

1. The resident shall meet the minimum nursing facility criteria, as well as meet the preadmission screening requirements for nursing facility level of care as specified in 12VAC30-60-300, Nursing facility criteria;

2. The resident has a physician's diagnosis of TBI which is also recorded on the Patient Intensity Rating System Review (DMAS-80) form by diagnosis code 85000 (trauma to the brain);

3. Abusive, aggressive, or disruptive behavior has been documented within 30 days prior to admission and also recorded on the Patient Intensity Rating System Review (DMAS-80) form by coding of behavior pattern 3 or 4. Behavior coding on the Patient Intensity Rating System Review form must also be supported by documentation in the medical record;

4. The resident is at least 14 years old; and

5. The resident must be appropriate for nursing facility placement and the facility must be able to safeguard him such that the resident will not be a physical or emotional danger to himself or other residents on the unit.

C. Provider criteria. Nursing facilities which may be approved to provide this service shall operate a dedicated unit of 20 beds or more and provide additional professional services to support the special needs of these individuals. These criteria shall concentrate individuals with TBI into specially dedicated facilities thereby satisfying safety concerns and achieving economies of scale necessary for the nursing facilities. At a minimum, the provider shall meet all of the criteria outlined below to receive the add-on reimbursement for the TBI program for residents who meet the TBI program resident criteria.

1. Provide all services that are available to the general nursing facility population in accordance with established standards and regulations for nursing facilities to include programming that is individualized and geared toward the needs and interests of the unit's population;

2. Provide a dedicated unit of at least 20 beds that is physically separated by a doorway that shall be either locked or maintained with an alarm system that sounds at the unit nursing station when opened;

3. Certify all beds on this dedicated unit for licensed nursing facility care. To receive payment the resident must reside in a Medicaid certified bed;

4. Locate at least one nursing station on the unit and that nursing station must serve the dedicated unit only;

5. Maintain a contractual agreement with a physiatrist and a neuropsychologist to serve the resident population as needed;

6. Provide a registered nurse to function in a charge nurse capacity on the unit whose sole responsibility is for the care and oversight of the designated unit. This registered nurse cannot have other responsibilities outside of the unit during the period for which she is designated as the charge nurse for the dedicated unit. The registered nurse working in a charge nurse capacity must have sufficient experience working with the population with head injuries before serving in this capacity. Temporary agency nurses cannot be used to fulfill the charge nurse requirement;

7. Ensure that each resident on the unit is evaluated on an annual basis by a licensed clinical psychologist with expertise in neuropsychology or a neurologist. If a resident is admitted and has not been evaluated by a neuropsychologist or neurologist in the past calendar year, an evaluation must be completed within the first 30 days of the resident's stay in the TBI program; and

8. Coordinate educational services for the resident with the appropriate public school system if the resident has not completed all educational requirements for high school education as specified by the State Board of Education. Coordination is defined as making the necessary contacts and providing necessary information to the appropriate school division. The facility shall keep records of such coordination contacts.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 14, Issue 22, eff. August 19, 1998.

Chapter 100 State Programs

Part I (Repealed)

12VAC30-100-10 (Repealed.)

Historical Notes

Derived from VR460-04-8.9 § 1, eff. May 1, 1994; repealed, Virginia Register Volume 25, Issue 3, eff. November 12, 2008.

12VAC30-100-20 (Repealed.)

History

• Historical Notes: Derived from VR460-04-8.9 § 1, eff. May 1, 1994; repealed, Virginia Register Volume 25, Issue 3, eff. November 12, 2008.

12VAC30-100-30 (Repealed.)

History

• Historical Notes: Derived from VR460-04-8.9 § 1, eff. May 1, 1994; repealed, Virginia Register Volume 25, Issue 3, eff. November 12, 2008.

12VAC30-100-40 (Repealed.)

History

• Historical Notes: Derived from VR460-04-8.9 § 1, eff. May 1, 1994; repealed, Virginia Register Volume 25, Issue 3, eff. November 12, 2008.

12VAC30-100-50 (Repealed.)

History

• Historical Notes: Derived from VR460-04-8.9 § 1, eff. May 1, 1994; repealed, Virginia Register Volume 25, Issue 3, eff. November 12, 2008.

12VAC30-100-60 (Repealed.)

History

• Historical Notes: Derived from VR460-04-8.9 § 1, eff. May 1, 1994; repealed, Virginia Register Volume 25, Issue 3, eff. November 12, 2008.

Part II State/Local Hospitalization Program

12VAC30-100-70 Definitions

The following words and terms, when used in this part, shall have the following meaning unless the context clearly indicates otherwise:

"Allocation process" means the process described in § 32.1-345 B of the Code of Virginia, which is used annually to allocate funds appropriated by the General Assembly for this program to counties and cities of the Commonwealth.

"Board of Medical Assistance Services" or "BMAS" means that board established by § 32.1-324 et seq. of the Code of Virginia.

"Bona fide resident" means an individual who has been determined by the local department of social services to be residing in the city or county where making application at the time of or immediately prior to medical treatment with the intent of remaining permanently in that locality and who did not establish residency for the purposes of obtaining benefits.

"Covered ambulatory surgical center services" means those services which are provided by any distinct licensed and certified entity, established by 42 CFR 416.2, that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization, which do not exceed in amount, duration, and scope those available to recipients of medical assistance services as provided in the State Plan for Medical Assistance established by Chapter 10 (§ 32.1-323 et seq.) of Title 32.1 of the Code of Virginia; and which are rendered by providers who have signed agreements to participate in the SLH program and who are enrolled providers in the MAP.

"Covered inpatient services" means inpatient services that do not exceed in amount, duration, and scope those available to recipients of medical assistance services as provided in the State Plan for Medical Assistance established by Chapter 10 (§ 32.1-323 et seq.) of Title 32.1 of the Code of Virginia and that are rendered by providers who have signed agreements to participate in the SLH program and who are enrolled providers in the MAP.

"Covered local public health services" means services provided by local health departments that do not exceed in amount, duration and scope those available to recipients of medical assistance services as provided in the State Plan for Medical Assistance established by Chapter 10 of Title 32.1 of the Code of Virginia and that are rendered by providers who have signed agreements to participate in the SLH program and who are enrolled providers in the MAP.

"Covered outpatient services" means outpatient services, as performed in an outpatient hospital setting, that do not exceed in amount, duration and scope those available to recipients of medical assistance services as provided in the State Plan for Medical Assistance established by Chapter 10 of Title 32.1 of the Code of Virginia and that are rendered by providers who have signed agreements to participate in the SLH program and who are enrolled providers in the MAP.

"Claim" means a request for payment for services rendered.

"Department" or "DMAS" means the Department of Medical Assistance Services established by § 32.1-323 of the Code of Virginia.

"Director" means the Director of the Department of Medical Assistance Services established by § 32.1-323 of the Code of Virginia.

"DRG" means diagnostic related group of codes to define the severity or intensity of illness.

"Enrolled provider" or "providers" means inpatient or outpatient hospitals, free-standing ambulatory surgical centers and local public health departments which have signed agreements to participate in the SLH program and are enrolled providers in the MAP.

"Indigent person" means a person who is a bona fide resident of the county or city, whether gainfully employed or not and who, either by himself or by those upon whom he is dependent, is unable to pay for required hospitalization or treatment. Residence shall not be established for the purpose of obtaining the benefits of this program. Aliens illegally living in the United States and migrant workers shall not be considered bona fide residents of the county or city for purposes of the SLH program.

"Locality" means any city or county which is required by law to participate in the SLH program.

"MAP" or "Medicaid" means the Medical Assistance Program as administered by the Department of Medical Assistance Services.

"Medical emergency" means that a delay in obtaining treatment may cause death or serious impairment of the health of the patient. See 42 CFR 440.170(e).

"Net countable income" means the value of income using the current budget methodology of the Virginia Aid to Families with Dependent Children Program.

"Net countable resources" means the countable value of an applicant's resources using the current budget methodology of the Virginia Aid to Families with Dependent Children Program.

"Payable claim" means a claim for a covered service rendered to an eligible individual with a date of service in the current SLH payment year provided that the claim is submitted for payment before the last payment processing cycle in June and provided there are funds available in the allocation for the locality of residence of the eligible individual.

"SLH payment year" means a year beginning May 1 of any year and ending April 30 of the following year.

"SLH program" means the State/Local Hospitalization Program.

"State Plan" means the State Plan for Medical Assistance for the Commonwealth.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-05-1000.0000 § 1.1, eff. May 1, 1994; amended Virginia Register Volume 12, Issue 18, eff. July 1, 1996.

12VAC30-100-80 Program established

The State/Local Hospitalization Program is hereby established, within the Department of Medical Assistance Services (DMAS), for indigent persons. The director of the department shall administer this program and expend state and local funds in accordance with the provisions of Chapter 12 (§ 32.1-343 et seq.) of Title 32.1 of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-344 and 32.1-346 of the Code of Virginia.
• Historical Notes: Derived from VR460-05-1000.0000 § 2.1, eff. May 1, 1994.

12VAC30-100-90 Allocation of funds

From the appropriation made by the General Assembly each state fiscal year, the director shall allocate funds to each locality in accordance with provisions of § 32.1-345 of the Code of Virginia. These allocations will be used for the sole purpose of processing payable claims for that SLH payment year.

History

• Statutory Authority: §§ 32.1-344 and 32.1-346 of the Code of Virginia.
• Historical Notes: Derived from VR460-05-1000.0000 § 2.2, eff. May 1, 1994.

12VAC30-100-100 Amount, duration, and scope of services covered

The amount, duration, and scope of services covered by the SLH program shall be equal to the amount, duration, and scope of the same services covered by the MAP established by the State Plan. SLH services shall be limited to inpatient and outpatient hospital services; and to services rendered in free-standing ambulatory surgical centers and local public health departments.

History

• Statutory Authority: §§ 32.1-344 and 32.1-346 of the Code of Virginia.
• Historical Notes: Derived from VR460-05-1000.0000 § 3.1, eff. May 1, 1994.

12VAC30-100-110 Changes in amount, duration, and scope of services covered

Changes in the amount, duration, and scope of services covered by the MAP shall, unless modified by the BMAS, automatically change the amount, duration, and scope of services covered by the SLH program.

History

• Statutory Authority: §§ 32.1-344 and 32.1-346 of the Code of Virginia.
• Historical Notes: Derived from VR460-05-1000.0000 § 3.2, eff. May 1, 1994.

12VAC30-100-120 Inpatient hospital reimbursement rate

The inpatient hospital reimbursement rate shall be consistent with the Medicaid inpatient rate methodology. However, no disproportionate share or medical education adjustment for SLH inpatient hospital reimbursement shall be provided. For the two-year DRG phase-in period beginning July 1, 1996, the daily inpatient hospital reimbursement rate shall be the same as that per diem rate established and in effect on July 1 of each year by DMAS for the specific hospital established by § 32.1-346 B 2 of the Code of Virginia. Inpatient hospital reimbursement rates for SLH services shall not be subject to readjustment through the year-end cost reporting process.

The department shall delay implementation of the Diagnosis Related Groups reimbursement methodology for inpatient hospital services provided under this program until July 1, 1999. Until that time, the daily inpatient hospital reimbursement rate shall be the same as the per diem rate established by the department and in effect on June 30, 1998.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia and Item 338 C of Chapter 464 of the 1998 Acts of Assembly.
• Historical Notes: Derived from VR460-05-1000.0000 § 3.3, eff. May 1, 1994; amended Virginia Register Volume 12, Issue 18, eff. July 1, 1996; Volume 14, Issue 18, eff. July 1, 1998.

12VAC30-100-130 Local health department and outpatient hospital clinics reimbursement

Reimbursement to local health departments and outpatient hospital clinics shall be an all inclusive fee per visit and at the rate established by § 32.1-346 B 1 of the Code of Virginia. Outpatient hospital clinics reimbursement rates shall not be subject to readjustment through the year-end cost reporting process.

History

• Statutory Authority: §§ 32.1-344 and 32.1-346 of the Code of Virginia.
• Historical Notes: Derived from VR460-05-1000.0000 § 3.4, eff. May 1, 1994.

12VAC30-100-140 Emergency services reimbursement

Reimbursement for hospital emergency room services shall be an all inclusive fee per visit and shall be reimbursed at the rate established by § 32.1-346 B 4 of the Code of Virginia. Emergency room services reimbursement rates shall not be subject to readjustment through the year-end cost reporting process.

History

• Statutory Authority: §§ 32.1-344 and 32.1-346 of the Code of Virginia.
• Historical Notes: Derived from VR460-05-1000.0000 § 3.5, eff. May 1, 1994.

12VAC30-100-150 Eligibility criteria

An individual is eligible to receive SLH program services if he:

1. Has filed an application with the locality where he resides within 30 days of discharge, in the case of inpatient services, or within 30 days of the date of service, in the case of outpatient services;

2. Is a bona fide resident of the locality to which he has applied;

3. Has a net countable income, using the current budget methodology of the Virginia Aid to Families with Dependent Children Program, equal to or less than 100% of the federal nonfarm poverty income guidelines as published for the then current year in the United States Code of Federal Regulations (CFR), except that localities which in fiscal year 1989 used a higher income level may continue to use the 1989 income level in subsequent years; and

4. Has net countable resources, using the current budget methodology of the Virginia Aid to Families with Dependent Children Program, equal to or less than the then current resource standards of the federal Supplemental Security Income Program (SSI).

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-05-1000.0000 § 4.1, eff. May 1, 1994; amended Virginia Register Volume 12, Issue 18, eff. July 1, 1996.

12VAC30-100-155 Application not required

The locality where the applicant resides is not required to accept an application to receive SLH program services from an individual after SLH locality funds have been exhausted for the fiscal year.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 18, eff. July 1, 1996.

12VAC30-100-160 Length of effective period of application

An eligibility decision favorable to the applicant shall remain in effect for a period of 180 days. If the recipient requires further medical treatment during the eligibility period, no new application shall be required. If the eligibility period has expired a new application shall be required.

History

• Statutory Authority: §§ 32.1-344 and 32.1-346 of the Code of Virginia.
• Historical Notes: Derived from VR460-05-1000.0000 § 4.2, eff. May 1, 1994.

12VAC30-100-170 Persons eligible for Title XIX services

Persons who have been determined eligible for services as defined by and contained in the Social Security Act Title XIX shall not be eligible for SLH program benefits established by § 32.1-346 B 3 of the Code of Virginia. This exclusion does not apply to Medicaid-eligible individuals who are enrolled in the Family Planning Waiver described in 12VAC30-135-10 through 12VAC30-135-40, or those determined eligible as a Qualified Medicare Beneficiary (QMB). Individuals determined eligible for Medicare coverage as a QMB may be determined eligible for SLH program benefits for the months prior to their enrollment for services as a QMB.

History

• Statutory Authority: §§ 32.1-324, 32.1-325, 32.1-344, 32.1-346 and 32.1-347 of the Code of Virginia.
• Historical Notes: Derived from VR460-05-1000.0000 § 4.3, eff. May 1, 1994; amended, Virginia Register Volume 24, Issue 25, eff. October 2, 2008.

12VAC30-100-180 Appeal

An applicant for SLH may appeal an appealable adverse determination regarding eligibility for services or liability for excess payments as defined in § 32.1-349 of the Code of Virginia. SLH appeals will follow the procedures established by Medicaid for client appeals. Exhaustion of appropriated funds in a given locality for payment of SLH services is not an appealable issue. Funds allocated for one fiscal year shall not be used to pay for provider claims in another fiscal year.

History

• Statutory Authority: §§ 32.1-344 and 32.1-346 of the Code of Virginia.
• Historical Notes: Derived from VR460-05-1000.0000 § 4.4, eff. May 1, 1994.

12VAC30-100-190 State funds remaining at the end of the fiscal year

State funds remaining at the end of the fiscal year shall be used as an offset to the calculated local share for the following year. The funds shall be allocated among localities in accordance with a procedure established by DMAS to ensure that state funds remaining at the end of the fiscal year are used first to offset increases in calculated local shares, then to offset calculated local share for all localities. Remaining state funds shall be applied toward offsetting calculated local share only and shall not be added to a locality's base allocation. State funds remaining at the end of the state fiscal year shall not be used for other purposes including payment for claims rendered in a prior SLH payment year.

History

• Statutory Authority: §§ 32.1-344 and 32.1-346 of the Code of Virginia.
• Historical Notes: Derived from VR460-05-1000.0000 § 5.1, eff. May 1, 1994.

12VAC30-100-200 Determination of liability for excess payments

The department shall be employed to recover excess SLH payments. Such disputes shall be heard in accordance with the Administrative Process Act. Potential fraud cases shall be referred to the appropriate law-enforcement agency.

History

• Statutory Authority: §§ 32.1-344 and 32.1-346 of the Code of Virginia.
• Historical Notes: Derived from VR460-05-1000.0000 § 6.1, eff. May 1, 1994.

Part III HIV Premium Assistance Program

12VAC30-100-250 Definitions

"Appeal" means the process by which an applicant or enrollee in the HIV Premium Assistance Program can obtain a review of a decision, action, or failure to act on the part of the program.

"Applicant" means an individual who has applied for or is in the process of applying for HIV Premium Assistance Program benefits.

"Applicant's representative" means a person who, because of the applicant's or enrollee's mental or physical incapacity or standing as a child, is permitted to act, complete, sign, or withdraw an application for the benefits of the program; activate the appeal process; and otherwise supply any information requested by the program on behalf of the applicant or enrollee.

"Child" means an unmarried person younger than 18 years of age and who lives with a parent or legal guardian.

"Date of application" means the date that an application is officially received by the program.

"Department" or "DMAS" means the Virginia Department of Medical Assistance Services which has administrative authority and responsibility for the program.

"Enrollee" means an individual who has been determined to be eligible for and is receiving assistance from the program.

"Family" means:

1. The applicant or enrollee,

2. The applicant or enrollee's spouse,

3. The applicant's or enrollee's children who are under 21 years if the children live with the applicant,

4. When the applicant or enrollee is a child:

a. The applicant's parent or parents,

b. The minor applicant's unmarried siblings under 21 years, at the option of the applicant's or enrollee's parents.

"Group health insurance plan" means a plan which meets § 5000(b)(1) of the Internal Revenue Code of 1986, as amended, includes continuation coverage pursuant to Title XXII of the Public Health Services Act, § 4980B of the Internal Revenue Code of 1986, or Title VI of the Employee Retirement Income Security Act of 1974, and is consistent with the provisions of the Consolidated Omnibus Budget Reconciliation Act of 1985, Public Law 99-272 and any subsequent modifications to the Act. Section 5000(b)(1) of the Internal Revenue Code provides that a group health plan is any plan of, or contributed to by, an employer (including a self-insured plan) to provide health care (directly or otherwise) to the employer's employees, former employees, or the families of such employees or former employees.

"Health insurance premiums" or "premiums" means the health insurance premiums paid by or on behalf of an individual in order to obtain or maintain health insurance plan benefits.

"HIV positive" means a positive diagnosis of infection with the human immune deficiency virus (HIV) as determined by the enzyme-linked immunosorbent assay (ELISA) and confirmed by the Western Blot, or another generally accepted diagnostic test for HIV infection.

"HIV Premium Assistance Program" or "the program" means the Virginia program that provides payment of health insurance premiums under certain circumstances to individuals who are HIV positive, in accordance with the provision of the Consolidated Omnibus Budget Reconciliation Act of 1985, Public Law 99-272 and any subsequent modifications to the Act and as authorized by § 32.1-330.1 of the Code of Virginia.

"Medicaid" means the state-federal medical assistance program of comprehensive medical and other health-related care for indigent and medically indigent persons authorized by Title XIX of the Social Security Act and administered by the Virginia Department of Medical Assistance Services.

"Nongroup health insurance plan" means a health insurance plan that is offered to an individual or an individual family unit without being tied to an employer.

"Physician verification" means certification by a licensed physician of medical information regarding an applicant's or enrollee's HIV positive status and inability to work due to the disease or the substantial likelihood that within three months the individual will be too ill to continue working.

"Poverty level" means the official federal poverty income level, as revised annually.

History

• Statutory Authority: §§ 32.1-325 and 32.1-330.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 15, eff. June 1, 1997.

12VAC30-100-260 Eligibility requirements

An applicant will be determined to be eligible for the HIV Premium Assistance Program if the individual:

1. Is a Virginia resident at the time of application and is:

a. A citizen of the United States;

b. An alien lawfully admitted for permanent residence or otherwise permanently residing in the United States under color of law, including an alien who is lawfully present in the United States pursuant to 8 USC § 1101 et seq.; or

c. An alien lawfully admitted under authority of the Indochina Migration and Refugee Assistance Act of 1975, 22 USC § 2601 et seq.;

2. Is certified by a licensed physician to be HIV positive;

3. Is certified by a licensed physician to be unable to work or to have a substantial likelihood of being unable to work within three months of the date of the physician's certification due to the HIV infection;

4. Is eligible for continuation of group health insurance plan benefits through the employer and the provisions of the Consolidated Omnibus Budget Reconciliation Act (COBRA) of 1985, or for continuation of benefits under any type of health insurance plan unless DMAS has reason to believe it is not cost effective;

5. Has applicant and spouse income no greater than 250% of the poverty level;

6. Has countable liquid assets no more than $10,000 in value; and

7. Is not eligible for Medicaid.

History

• Statutory Authority: §§ 32.1-325 and 32.1-330.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 15, eff. June 1, 1997; amended, Virginia Register Volume 16, Issue 18, eff. July 1, 2000; Volume 32, Issue 1, eff. October 22, 2015.

12VAC30-100-270 Determination of countable income and liquid assets

When determining eligibility for the HIV Premium Assistance Program, the countable income and assets of each applicant shall be determined as follows:

1. Income shall include total projected applicant and spouse income for the year beginning with the month of application to the program, including but not limited to:

a. Wages;

b. Commissions and fees;

c. Salaries and tips;

d. Profit from self-employment;

e. Dividends or interest income;

f. Disability benefits;

g. Unemployment;

h. Pension or retirement.

2. Countable liquid assets shall include assets available as of the date of the application which are convertible to cash. The following liquid assets shall be counted when determining eligibility:

a. Savings accounts;

b. Checking accounts;

c. Money market certificates;

d. Certificates of deposit;

e. Mutual funds;

f. Stocks and bonds; or

g. All other liquid assets as provided in § 6.2-1100 of the Code of Virginia.

History

• Statutory Authority: §§ 32.1-325 and 32.1-330.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 15, eff. June 1, 1997; amended, Virginia Register Volume 32, Issue 1, eff. October 22, 2015.

12VAC30-100-280 Program application and enrollment

A. Any person requesting participation in the program shall be given the opportunity to file an application and, if determined eligible by the program, shall be enrolled in accordance with the provisions of this part within established funding constraints.

B. An applicant or applicant's representative shall complete an application on the form designated by the program. The program may request additional documentation for eligibility determination purposes as it deems necessary.

C. An unmarried child younger than 18 years old shall have a representative complete and sign the application.

D. Applications shall conform with the requirements of this part and those set forth by the program. Applicants shall be determined ineligible without prejudice when they fail to provide information sufficient for the determination of eligibility.

E. An applicant or applicant's representative shall sign a statement authorizing the program to verify from any source, including banks and public or private agencies providing monetary benefits, qualifying information submitted to the program as part of the application process. Refusal to sign an authorization shall be considered failure to provide sufficient information, and applicants shall be determined ineligible in accordance with the provisions of this policy.

F. Eligibility determination shall be made promptly, not later than 30 days from the date of receipt of the completed application by the program.

G. An applicant or applicant's representative may voluntarily withdraw the application at any time without prejudice.

H. An individual previously determined ineligible for program benefits may submit a new application at any time.

I. Program enrollment shall be effective on the day eligibility is approved. Premium payments for health insurance coverage beginning on the first day of the month following eligibility shall start as long as there is available funding.

History

• Statutory Authority: §§ 32.1-325 and 32.1-330.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 15, eff. June 1, 1997.

12VAC30-100-290 Changes in eligibility

A. The program will promptly redetermine eligibility when it receives information concerning an enrollee's circumstances that may affect eligibility.

B. The enrollee or representative shall notify the program within 10 working days of any changes in circumstances which would affect continuing eligibility, including but not limited to:

1. Sale, transfer or change of the value of assets;

2. Change in income;

3. Change in name or address;

4. Change in COBRA eligibility.

C. If any changes in status result in an enrollee no longer qualifying for the program, the enrollee shall be considered ineligible for program benefits and enrollment shall be canceled. The cancellation shall be effective on the last day of the month in which notice has been given consistent with 12VAC30-100-320. The program shall notify the enrollee of its determination in writing, and inform the enrollee of any legal rights to appeal the decision pursuant to the notification requirements of this policy.

D. Failure to make such required notification may be considered to be fraudulent and may be addressed pursuant to the department's fraud prevention and control policies (12VAC30-100-360).

History

• Statutory Authority: §§ 32.1-325 and 32.1-330.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 15, eff. June 1, 1997.

12VAC30-100-300 Enrollee openings

A. The number of enrollees in the program shall be limited to the number that can be covered by the program's available funding as reflected in available openings. DMAS shall project the expenditures for the current and expected enrollees and funding levels for the program to determine the number of available enrollee openings.

B. Initial available openings in the program shall be filled based on the applicant's date of completed application. In the event that more than one application is received on any one day, applicants shall be considered based on the order of the day and month of the applicant's birth, with January being month one.

C. Should the number of applications exceed available funding at any time, a waiting list shall be maintained by the program of applicants who are determined to be eligible for the program but for whom openings are not available when the eligibility determinations are made.

1. Available openings shall be filled from the waiting list on a first come, first served basis, using the same criteria defined in 12VAC30-100-300.

2. If an opening becomes available, the applicant shall be notified in writing by the program. The applicant must provide any necessary information to the program to verify that he is still eligible within 10 days of receiving such notification. The 10-day period may be extended by the program for just cause. If determined to be still eligible, the applicant shall be enrolled.

3. At the end of three months from the date of application, and every three months thereafter, if an opening has not yet become available, each applicant may be contacted by DMAS to verify the applicant's interest in remaining on the waiting list. At these contacts, applicants may be requested to inform the program of changes in the contents of their applications. At such time as funding becomes available for waiting list applicants, DMAS shall reexamine the applications for program qualifications.

History

• Statutory Authority: §§ 32.1-325 and 32.1-330.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 15, eff. June 1, 1997.

12VAC30-100-310 Authorization for benefits

Authorization for benefits under this program shall be granted until program termination, unless the recipient's status changes so that he no longer meets the eligibility criteria.

History

• Statutory Authority: §§ 32.1-325 and 32.1-330.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 15, eff. June 1, 1997.

12VAC30-100-320 Notification

The program shall inform an applicant, enrollee, or the individual's representative of the individual's legal rights and obligations and give written notice of the following:

1. The final determination on an application, which shall include the reason or reasons if an applicant is found ineligible;

2. The imminent expiration of program authority and funding;

3. A notice of action to deny, cancel, or suspend program benefits which shall:

a. Include a statement of the proposed action, the reason for the action, and the statutory or regulatory authority for the action;

b. Include notification of the right to appeal the action;

c. Be mailed at least 15 calendar days before the effective date of the action.

History

• Statutory Authority: §§ 32.1-325 and 32.1-330.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 15, eff. June 1, 1997; amended, Virginia Register Volume 32, Issue 1, eff. October 22, 2015.

12VAC30-100-330 Appeals

A. An applicant, enrollee, or representative who is dissatisfied with a decision, action, or inaction of the program may request and shall be granted an opportunity to appeal, as provided for under the department's Client Appeals Regulations (12VAC30-110-10 through 12VAC30-110-380).

B. The applicant or enrollee shall request in writing reconsideration from the HIV Premium Assistance Program within 15 days of the denial notice. DMAS will respond within five days to this request for reconsideration. If the applicant or enrollee still disagrees with DMAS' decision, he shall have the right to file an appeal in accordance with the department's Client Appeals Regulations.

C. An enrollee shall be notified in writing by the program that the program shall be responsible for the payment of health insurance premiums until the appeal process is concluded. If the appeal results in the enrollee being found ineligible for the program, the program shall seek recovery in accordance with the department's recovery policies.

D. If an applicant is found eligible for the program as a result of an appeal, the program shall reimburse the applicant directly for premiums which were paid, beginning with a premium payment for the month following the decision that was the subject of appeal. The applicant shall provide proof of payment of premiums.

E. Cases on appeal which are in current payment status shall be considered filled enrollee openings until the appeal process has been completed.

History

• Statutory Authority: §§ 32.1-325 and 32.1-330.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 15, eff. June 1, 1997.

12VAC30-100-340 Health insurance premium payments

A. Premium payments shall be made to the employer, the insurer, or the enrollee, according to procedures established by the program.

B. Applicants and enrollees shall provide information as may be necessary for the payment of health insurance premiums by the program, including but not limited to the name and address of the employer or health insurance company, the last day of employment, the type of policy, the amount of the premium, and the date by which the premium must be paid.

C. Payments under this program are limited to the cost of the health insurance premium currently in effect and shall not include copayments, deductibles, or any other costs incurred by the enrollees. Payments under this program shall include coverage of family members if the enrollee's policy is the sole source of health insurance.

History

• Statutory Authority: §§ 32.1-325 and 32.1-330.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 15, eff. June 1, 1997; amended, Virginia Register Volume 32, Issue 1, eff. October 22, 2015.

12VAC30-100-350 Recovery

In all cases in which program benefits have been incorrectly paid or paid during an appeal in which the program action was upheld, the program shall seek recovery from the payee, according to the department's recovery policies.

History

• Statutory Authority: §§ 32.1-325 and 32.1-330.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 15, eff. June 1, 1997.

12VAC30-100-360 Fraud

Cases of suspected misrepresentation or fraud shall be investigated according to the department's fraud prevention and control policies and any other applicable statutory provision.

History

• Statutory Authority: §§ 32.1-325 and 32.1-330.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 15, eff. June 1, 1997.

12VAC30-100-370 Confidentiality

All information maintained by the program containing personal data including name, address, employer, insurance company, HIV status, application to or enrollment in the program, and any other information which could identify or reasonably be used to identify any applicant or enrollee in the program shall be maintained in confidence according to all applicable DMAS policies and procedures and any other applicable laws or regulations. Such information shall not be disclosed to any individual or organization without the written and dated consent of the applicant, enrollee, or representative.

History

• Statutory Authority: §§ 32.1-325 and 32.1-330.1 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 15, eff. June 1, 1997.

Part IV Health Insurance for the Working Uninsured (Repealed)

12VAC30-100-400 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 14, Issue 25, eff. October 1, 1998; repealed, Virginia Register Volume 29, Issue 25, eff. September 26, 2013.

12VAC30-100-410 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 14, Issue 25, eff. October 1, 1998; repealed, Virginia Register Volume 29, Issue 25, eff. September 26, 2013.

12VAC30-100-420 [Withdrawn]

Historical Notes

Derived from Virginia Register Volume 14, Issue 25, eff. October 1, 1998; withdrawn, Virginia Register Volume 15, Issue 2 (October 12, 1998).

12VAC30-100-430 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 14, Issue 25, eff. October 1, 1998; repealed, Virginia Register Volume 29, Issue 25, eff. September 26, 2013.

12VAC30-100-440 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 14, Issue 25, eff. October 1, 1998; repealed, Virginia Register Volume 29, Issue 25, eff. September 26, 2013.

12VAC30-100-450 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 14, Issue 25, eff. October 1, 1998; repealed, Virginia Register Volume 29, Issue 25, eff. September 26, 2013.

12VAC30-100-460 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 14, Issue 25, eff. October 1, 1998; repealed, Virginia Register Volume 29, Issue 25, eff. September 26, 2013.

12VAC30-100-470 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 14, Issue 25, eff. October 1, 1998; repealed, Virginia Register Volume 29, Issue 25, eff. September 26, 2013.

12VAC30-100-480 (Repealed.)

Historical Notes

Previously reserved; repealed with chapter, Virginia Register Volume 29, Issue 25, eff. September 26, 2013.

12VAC30-100-490 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 14, Issue 25, eff. October 1, 1998; repealed, Virginia Register Volume 29, Issue 25, eff. September 26, 2013.

Chapter 110 Eligibility and Appeals

Article 1 Definitions

12VAC30-110-10 Definitions

The following words and terms, when used in these regulations, shall have the following meanings unless the context clearly indicates otherwise:

"Action" means a denial of, termination of, suspension of, or reduction in covered benefits or services; a denial of or termination, suspension, or reduction in Medicaid eligibility; or an increase in beneficiary liability, including a determination that a beneficiary must incur a greater amount of medical expenses in order to establish income eligibility in accordance with 42 CFR 435.121(e)(4) or 42 CFR 435.831 or is subject to an increase in premiums or cost-sharing charges under Subpart A of 42 CFR Part 447. It also means (i) determinations by a skilled nursing facility or nursing facility to transfer, discharge, or fail to readmit a resident and (ii) an adverse determination made by a state with regard to the preadmission screening and resident review requirements of § 1919(e)(7) of the Social Security Act. It also means the failure to take an application for benefits or to act with reasonable promptness on an application for benefits, on a reported change in circumstances, or on a request for a particular medical service.

"Adverse determination" means a determination made in accordance with § 1919(b)(3)(F) or 1919(e)(7)(B) of the Social Security Act that the individual does not require the level of services provided by a nursing facility or that the individual does or does not require specialized services.

"Agency" means:

1. An agency or contractor that, on the department's behalf, makes determinations regarding benefits or applications for benefits provided by the department; or

2. The department itself.

"Appellant" means (i) an applicant for or recipient of medical assistance benefits from the department who seeks to challenge an action regarding the applicant's benefits or the applicant's eligibility for benefits and (ii) a nursing facility resident who seeks to challenge a transfer, discharge, or failure to readmit. Appellant also means an individual who seeks to challenge an adverse determination regarding services provided by a nursing facility.

"Burden of proof" means the duty placed upon a party to prove or disprove a disputed fact.

"Date of action" means the intended date on which a termination, suspension, reduction, transfer, or discharge becomes effective. It also means the date of the determination made by a state with regard to the preadmission screening and annual resident review requirements of § 1919(e)(7) of the Social Security Act.

"Day" means calendar day unless otherwise specified or required by law.

"De novo" means that, where a hearing is required, the department's hearing officer will consider all relevant evidence submitted during the appeal in order to make a determination on the issues on appeal, even if the evidence was not previously received by the agency.

"Department" means the Department of Medical Assistance Services.

"Division" means the department's Appeals Division.

"Fail to readmit" means when a nursing facility refuses to readmit a resident who meets the criteria for a bed hold under 42 CFR 438.15.

"Final decision" means a written determination by a hearing officer that is binding on the department, unless modified on appeal or review.

"Hearing" means the de novo evidentiary hearing described in this chapter, conducted by a hearing officer employed by the department.

"Preponderance of the evidence" means that the party with the burden of proof has demonstrated to the hearing officer that their position on the issue in the appeal is more likely valid than not.

"Representative" means an attorney or agent who has been authorized to represent an appellant pursuant to these regulations.

"Send" means to deliver by mail or in electronic format consistent with 42 CFR 431.201 and 42 CFR 435.918.

"State fair hearing" means the entire appeal process for applicants and beneficiaries as set forth in 42 CFR Subpart E.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-04-8.7 § 1.1, eff. October 1, 1993; amended, Virginia Register Volume 11, Issue 17, eff. June 15, 1995; Volume 31, Issue 16, eff. May 6, 2015; Volume 34, Issue 6, eff. December 13, 2017; Volume 40, Issue 22, eff. August 1, 2024.

Article 2 Appeal System

12VAC30-110-20 Appeals Division

Article 2 Appeal System

A. The division maintains an appeals system that complies with all federal legal authority for appellants to challenge actions, as defined in 42 CFR 431.201, regarding services and benefits provided by the agency or a nursing facility. Appellants shall be entitled to a hearing before a hearing officer. See Subpart II (12VAC30-110-130 et seq.) of this chapter.

B. The appeals system shall be accessible to persons who are limited English proficient and persons who have disabilities, consistent with 42 CFR 435.905(b).

C. In accordance with 42 CFR 435.918, the agency makes electronic appeal correspondence available to applicants and recipients. Applicants and recipients may elect to receive appeal correspondence in electronic format or by regular mail and may change such election.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-04-8.7 § 1.2, eff. October 1, 1993; amended, Virginia Register Volume 11, Issue 17, eff. June 15, 1995; Volume 31, Issue 16, eff. May 6, 2015; Volume 34, Issue 6, eff. December 13, 2017.

12VAC30-110-30 Time limitation for appeals

Hearing officer appeals shall be scheduled and conducted to comply with the time limitations for standard and expedited appeals imposed by federal regulations, unless:

1. The agency cannot reach a decision because the appellant requests a delay or fails to take a required action; or

2. There is an administrative or other emergency beyond the agency's control.

All instances in which there is a delay shall be documented in the appellant's record.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.7 § 1.3, eff. October 1, 1993; amended, Virginia Register Volume 11, Issue 17, eff. June 15, 1995; Volume 34, Issue 6, eff. December 13, 2017.

12VAC30-110-35 Expedited appeals

A. An appellant may request and the agency shall provide an expedited appeals process for claims for which the agency determines that the 90-day timeframe for conducting an appeal could jeopardize the individual's life, health, or ability to attain, maintain, or regain maximum function.

B. If an expedited appeal request is granted, the following timeframes for conducting the appeal apply from receipt of the appeal request:

1. Seventy-two hours for:

a. A claim related to services or benefits described in 42 CFR 431.220(a)(1);

b. A MCO, PIHP, or PAHP enrollee who is entitled to a hearing under Subpart F of 42 CFR Part 438;

c. An enrollee in a nonemergency medical transportation prepaid ambulatory health plan who has an action; and

d. An enrollee who is entitled to a hearing under Subpart B of 42 CFR Part 438.

2. Seven business days for:

a. Eligibility claims;

b. Nursing facility claims related to transfer or discharge; or

c. Nursing facility claims related to the agency's preadmission determination or annual resident review.

C. The department shall notify the individual whether the request is granted or denied as expeditiously as possible. Such notice may be provided orally or through the electronic means found in 12VAC30-110-130.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 34, Issue 6, eff. December 13, 2017.

12VAC30-110-40 Judicial review

An appellant who believes a final decision as defined herein is incorrect may seek judicial review pursuant to The Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) and Part 2A, Rules of the Virginia Supreme Court.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.7 § 1.4, eff. October 1, 1993; amended, Virginia Register Volume 11, Issue 17, eff. June 15, 1995; Volume 25, Issue 14, eff. April 15, 2009.

Article 3 Representation

12VAC30-110-50 Right to representation

Article 3 Representation

An appellant shall have the full right to representation by an attorney or agent at all stages of appeal.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.7 § 1.5, eff. October 1, 1993.

12VAC30-110-60 Designation of representative

A. Agents. An agent must be designated in a written statement which is signed by the appellant. If the appellant is physically or mentally unable to sign a written statement, the division may allow a family member or other person acting on appellant's behalf to represent the appellant.

B. Attorneys. If the agent is an attorney or a paralegal working under the supervision of an attorney, a signed statement by such attorney or paralegal that he is authorized to represent the appellant prepared on the attorney's letterhead, shall be accepted as a designation of representation.

C. Substitution. A member of the same law firm as a designated representative shall have the same rights as the designated representative.

D. Revocation. An appellant may revoke representation by another person at any time. The revocation is effective when the department receives written notice from the appellant.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.7 § 1.6, eff. October 1, 1993.

Article 4 Notice and Appeal Rights

12VAC30-110-70 Notification of adverse agency action

Article 4 Notice and Appeal Rights

The agency that takes action or makes an adverse determination shall inform the applicant or recipient in a written notice:

1. What action or adverse determination the agency intends to take and the effective date of such action;

2. A clear statement of the specific reasons supporting the intended action or adverse determination;

3. The specific regulations that support or the change in law that requires the action or adverse determination;

4. The right to request an evidentiary hearing, and the methods and time limits for doing so;

5. The right to request an expedited evidentiary hearing;

6. The circumstances under which benefits are continued if a hearing is requested (see 12VAC30-110-100); and

7. The right to representation.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-04-8.7 § 1.7, eff. October 1, 1993; amended, Virginia Register Volume 31, Issue 16, eff. May 6, 2015; Volume 34, Issue 6, eff. December 13, 2017.

12VAC30-110-80 Advance notice

When the agency plans to terminate, suspend, or reduce an individual's eligibility or covered services, the agency must send the notice described in 12VAC30-110-70 at least 10 days before the date of action, except as otherwise permitted by federal law in 42 CFR 431.213 and 42 CFR 431.214.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-04-8.7 § 1.8, eff. October 1, 1993; amended, Virginia Register Volume 31, Issue 16, eff. May 6, 2015; Volume 34, Issue 6, eff. December 13, 2017.

12VAC30-110-90 Right to appeal

An individual has the right to file an appeal when:

1. His application for benefits administered by the department is denied. However, if an application for State and Local Hospitalization coverage is denied because of a lack of funds which is confirmed by the hearing officer, there is no right to appeal;

2. The agency takes action or proposes to take action that will adversely affect, reduce, or terminate his receipt of benefits;

3. His request for a particular medical service is denied, suspended, reduced, or terminated, in whole or in part;

4. The agency fails to take an application and/or fails to act with reasonable promptness on his application for benefits or request for a particular medical service;

5. The agency takes action or proposes to take action regarding the recovery of applicable medical assistance payments from a decedent's estate;

6. The agency takes action or proposes to take action regarding the recovery of expenditures for services received by ineligible individuals;

7. The agency takes action or proposes to take action regarding the recovery of expenditures paid on behalf of individuals whose coverage was continued during the appeals process; or

8. Federal regulations require that a fair hearing be granted.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.7 § 1.9, eff. October 1, 1993; amended, Virginia Register Volume 22, Issue 26, eff. November 20, 2006.

12VAC30-110-100 Maintaining services

A. If the agency sends the 10-day notice described in 12VAC30-110-80 and the appellant files his Request for Appeal before the date of action, his services shall not be terminated or reduced until the hearing officer issues a final decision unless it is determined at the hearing that the sole issue is one of federal or state law or policy and the appellant is promptly informed in writing that services are to be terminated or reduced pending the final decision.

B. If the agency's action is sustained on appeal, the agency may institute any available recovery procedures against the appellant to recoup the cost of any services furnished to the appellant, to the extent they were furnished solely by reason of subsection A of this section.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-04-8.7 § 1.10, eff. October 1, 1993; amended, Virginia Register Volume 31, Issue 16, eff. May 6, 2015.

Article 5 Miscellaneous Provisions

12VAC30-110-110 Appeals Division records

Article 5 Miscellaneous Provisions

A. Removal of records. No person shall take from the division's custody any original record, paper, document, or exhibit that has been certified to the division except as the Director of the Appeals Division authorizes, or as may be necessary to furnish or transmit copies for other official purposes.

B. Confidentiality of records. Information in the appellant's record can be released only to a properly designated representative or other person or persons named in a release of information authorization signed by an appellant, his guardian, or power of attorney.

C. Fees. The fees to be charged and collected for any copies will be in accordance with Virginia's Freedom of Information Act (§ 2.2-3700 et seq. of the Code of Virginia) or other controlling law.

D. Waiver of fees. When copies are requested from records in the division's custody, the required fee shall be waived if the copies are requested in connection with an individual's own review or appeal.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-04-8.7 § 1.11, eff. October 1, 1993; amended, Virginia Register Volume 31, Issue 16, eff. May 6, 2015.

12VAC30-110-120 Computation of time limits

A. Acceptance of postmark date. Documents postmarked on or before a time limit's expiration shall be accepted as timely.

B. Computation of time limit. In computing any time period under these regulations, the day of the act or event from which the designated period of time begins to run shall be excluded and the last day included. If a time limit would expire on a Saturday, Sunday, or state or federal holiday, it shall be extended until the next regular business day.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.7 § 1.12, eff. October 1, 1993.

Article 1 Commencement of Appeals

12VAC30-110-130 Request for appeal

Subpart II Hearing Officer Review

Article 1 Commencement of Appeals

A. An appeal may be filed by any of the following methods:

1. By telephone;

2. Via email;

3. In person; and

4. Through other commonly available electronic means supported by the agency.

B. Any communication in the formats specified in subsection A of this section from an appellant or his representative that clearly expresses that he wants to present his case to a reviewing authority shall constitute an appeal request. This communication should explain the basis for the appeal.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-04-8.7 § 2.1, eff. October 1, 1993; amended, Virginia Register Volume 34, Issue 6, eff. December 13, 2017.

12VAC30-110-140 Place of filing a Request for Appeal

A Request for Appeal shall be sent to the Appeals Division.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-04-8.7 § 1.11, eff. October 1, 1993; amended, Virginia Register Volume 31, Issue 16, eff. May 6, 2015.

12VAC30-110-150 Filing date

The date of filing shall be the date the request is postmarked, if mailed, or the date the request is received by the department, if delivered other than by mail.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.7 § 2.3, eff. October 1, 1993.

12VAC30-110-160 Time limit for filing

A Request for Appeal shall be filed within 30 days of the appellant's receipt of the notice of an action or adverse determination described in 12VAC30-110-70. It is presumed that appellants will receive the notice five days after the agency mails the notice unless the appellant shows that he did not receive the notice within the five-day period. A Request for Appeal on the grounds that an agency has not acted with reasonable promptness may be filed at any time until the agency has acted.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-04-8.7 § 1.11, eff. October 1, 1993; amended, Virginia Register Volume 31, Issue 16, eff. May 6, 2015.

12VAC30-110-170 Extension of time for filing

An extension of the 30-day period for filing a Request for Appeal may be granted for good cause shown. Examples of good cause include the following situations:

1. Appellant was seriously ill and was prevented from contacting the division;

2. Appellant did not receive notice of the agency's action or adverse determination;

3. Appellant sent the Request for Appeal to another government agency in good faith within the time limit;

4. Unusual or unavoidable circumstances prevented a timely filing.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-04-8.7 § 2.5, eff. October 1, 1993; amended, Virginia Register Volume 34, Issue 6, eff. December 13, 2017.

12VAC30-110-180 Provision of information

Upon receipt of a Request for Appeal, the division shall notify the appellant and his representative of general appeals procedures and shall provide further detailed information upon request.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.7 § 2.6, eff. October 1, 1993.

12VAC30-110-185 Appeal summary

A. The agency proposing the action about which the individual requested the state fair hearing shall complete an appeal summary, which shall include:

1. The appellant's name and case name, if different;

2. The appellant's case number, Medicaid identification number, or other identifying information;

3. The agency or contractor responsible for the appellant's case;

4. A summary of the facts surrounding and the grounds supporting the action, the failure to take an application for benefits or to act with reasonable promptness on an application for benefits, a reported change in circumstances, or a request for a particular medical service. The summary of facts must include:

a. A list of the documents reviewed or relied upon, including those reviewed as part of the appeal.

b. A narrative explanation describing the agency's or contractor's position on the action when considering all documentation submitted until the appeal summary is filed. When the action under appeal is for a reduction of termination of existing coverage, the narrative should include an explanation as to what has changed or how the previous approval was made in error.

5. Citations to the statutes, regulations, and specific provisions of the Virginia Medical Assistance Eligibility manual or other policy that support the agency's action; and

6. The adverse benefit determination or the decision notice and any other documents relating to the appeal upon which the agency relied in making its decision.

B. The summary shall be filed with the department's Appeals Division with a complete copy sent to the appellant and the appellant's authorized representative, if applicable, at least five business days before the hearing date.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 40, Issue 22, eff. August 1, 2024.

Article 2 Prehearing Review

12VAC30-110-190 Review

Article 2 Prehearing Review

A hearing officer shall initially review an assigned case for compliance with prehearing requirements and may communicate with the appellant or his representative and the agency to confirm the agency action and schedule the hearing.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.7 § 2.7, eff. October 1, 1993.

12VAC30-110-200 Medical assessment

A. A hearing officer may order an independent medical assessment when:

1. The hearing involves medical issues such as a diagnosis, an examining physician's report, or a medical review team's decision; and

2. The hearing officer determines it necessary to have an assessment by someone other than the person or team who made the original decision, for example, to obtain more detailed medical findings about the impairments, to obtain technical or specialized medical information, or to resolve conflicts or differences in medical findings or assessments in the existing evidence.

B. A medical assessment ordered pursuant to this regulation shall be at the department's expense and shall become part of the record.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.7 § 2.8, eff. October 1, 1993.

12VAC30-110-210 Prehearing action

A. Invalidation. A Request for Appeal may be invalidated if it was not filed within the time limit imposed by 12VAC30-110-160 or extended pursuant to 12VAC30-110-170.

1. If the hearing officer determines that the appellant has failed to file a timely appeal, the hearing officer shall notify the appellant and the appellant's representative of the opportunity to show good cause for the late appeal.

2. If a factual dispute exists about the timeliness of the Request for Appeal, the hearing officer shall receive evidence or testimony on those matters before taking final action.

3. If the individual filing the appeal is not the appellant or an authorized representative of the appellant under the provisions of 12VAC30-110-60 A, the appeal shall be determined invalid.

4. If a Request for Appeal is invalidated, the hearing officer shall issue a decision pursuant to 12VAC30-110-370.

B. Administrative dismissal. Request for Appeal may be administratively dismissed without a hearing if the appellant has no right to appeal under 12VAC30-110-90.

1. If the hearing officer determines that the appellant does not have the right to an appeal, the hearing officer shall issue a final decision dismissing the appeal and notify the appellant and appellant's representative of the opportunity to seek judicial review.

2. If a Request for Appeal is administratively dismissed, the hearing officer shall issue a decision pursuant to 12VAC30-110-370.

C. Judgment on the record. If the hearing officer determines from the record that the agency's determination was clearly in error and that the case should be resolved in the appellant's favor, he shall issue a decision pursuant to 12VAC30-110-370.

D. Remand to agency. If the hearing officer determines from the record that the case might be resolved in the appellant's favor if the agency obtains and develops additional information, documentation, or verification, he may remand the case to the agency for action consistent with the hearing officer's written instructions. The remand order shall be sent to the appellant and any representative.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.7 § 2.9, eff. October 1, 1993; amended, Virginia Register Volume 11, Issue 17, eff. June 15, 1995.

Article 3 Hearing

12VAC30-110-220 Evidentiary hearings

A. General. The hearing officer shall review all agency determinations that are properly appealed; conduct informal, fact-gathering hearings; evaluate evidence presented; and issue a written final decision that is based on the evidence, policy, laws, and regulations relevant to the appeal.

B. De novo hearing. All hearings shall be considered "de novo," meaning that the department's hearing officer will consider all relevant evidence submitted during the appeal in order to make a determination on the issues on appeal, even if the evidence was not previously received by the agency. The hearing officer shall consider testimony and evidence that explains, supports, or is probative to the issues on appeal. In the de novo hearing, no deference is given to the agency or contractor who took the action.

C. Burden of proof. The burden of proof shall be assigned to the party that is attempting to make a change. If an individual is seeking initial Medicaid eligibility, the initial approval of Medicaid covered services, or eligibility for a higher level of coverage than has already been approved, the individual has the burden of proof. Conversely, when an already-eligible individual is facing a proposed termination or reduction in Medicaid eligibility or medical services, the burden of proof shall be assigned to the entity that has proposed the change to an individual's coverage. To prevail in the appeal, the party with the assigned burden of proof shall establish its position by a preponderance of the evidence.

D. Submission of evidence. The appellant's appeal request should include all documents the appellant would like considered during the appeal. The appellant can also submit additional documents leading up to and during the appeal hearing. The hearing officer has the discretion to reschedule or delay a hearing in order to allow the hearing officer and agency time to review documents submitted close to or at the scheduled hearing. Post-hearing supplementation of the record is addressed in 12VAC30-110-360. If the appeal request does not identify the action being appealed with reasonable specificity, include documentation to validate authorization for representation, if elected, or the department requests good cause for late filing of the appeal, then delay will be added to the appeal decision due date per 42 CFR 431.244.

E. Previously approved coverage. In an appeal involving a proposed termination or reduction of previously approved coverage, the existence of the prior approval shall create a presumption that the approval was proper when it was previously made if it was consecutive to the current request. The strength of this presumption is directly related to the number and duration of previous approvals. For the entity that has proposed the termination or reduction to satisfy its burden of proof, it must demonstrate that the individual's circumstances have changed or that the previous approval was made in error.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.7 § 2.10, eff. October 1, 1993; amended, Virginia Register Volume 40, Issue 22, eff. August 1, 2024.

12VAC30-110-230 Scheduling and rescheduling

A. To the extent possible, hearings will be scheduled at the appellant's convenience, with consideration of the travel distance required.

B. A hearing shall be rescheduled at the claimant's request no more than twice unless compelling reasons exist.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.7 § 2.11, eff. October 1, 1993; amended, Virginia Register Volume 11, Issue 17, eff. June 15, 1995.

12VAC30-110-240 (Repealed.)

Historical Notes

Derived from VR460-04-8.7 § 2.11.1, eff. October 1, 1993; repealed, Virginia Register Volume 11, Issue 17, eff. June 15, 1995.

12VAC30-110-250 Notification

When a hearing is scheduled, the appellant and his representative shall be notified in writing of its time and place.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.7 § 2.12, eff. October 1, 1993.

12VAC30-110-260 Postponement

A hearing may be postponed for good cause shown. No postponement will be granted beyond 30 days after the date of the Request for Appeal was filed unless the appellant or his representative waives in writing the 90-day deadline for the final decision.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.7 § 2.13, eff. October 1, 1993.

12VAC30-110-270 Location

The hearing location shall be determined by the division. If for medical reasons the appellant is unable to travel, the hearing may be conducted at his residence.

The agency may respond to a series of individual requests for hearings by conducting a single group hearing:

1. Only in cases in which the sole issue involved is one of federal or state law or policy; and

2. Each person must be permitted to present his own case or be represented by his authorized representative.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.7 § 2.14, eff. October 1, 1993.

12VAC30-110-280 Client access to records

Upon the request of the appellant or his representative, at a reasonable time before the date of the hearing, as well as during the hearing, the appellant and his representative may examine the content of appellant's case file and all documents and records the agency will rely on at the hearing.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.7 § 2.15, eff. October 1, 1993.

12VAC30-110-285 Appeals Division access to agency records

A hearing officer shall have access to agency information necessary to issue a proper hearing decision that is sound and legally supportable, including information concerning state policies and regulations.

History

• Statutory Authority: § 32.1-325 f the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 31, Issue 16, eff. May 6, 2015.

12VAC30-110-290 Subpoenas

Appellants who require the attendance of witnesses or the production of records, memoranda, papers, and other documents at the hearing may request issuance of a subpoena in writing. The request must be received by the division at least five business days before the hearing is scheduled. Such request must include the witness' name, home and work address, county or city of work and residence, and identify the sheriff's office which will serve the subpoena.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.7 § 2.16, eff. October 1, 1993.

12VAC30-110-300 Role of the hearing officer

The hearing officer shall conduct the hearing, decide on questions of evidence, procedure and law, question witnesses, and assure that the hearing remains relevant to the issue or issues being appealed. The hearing officer shall control the conduct of the hearing and decide who may participate in or observe the hearing.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.7 § 2.17, eff. October 1, 1993; amended, Virginia Register Volume 10, Issue 23, eff. October 1, 1994.

12VAC30-110-310 Informality of hearings

Hearings shall be conducted in an informal, nonadversarial manner. The appellant or his representative has the right to bring witnesses, establish all pertinent facts and circumstances; present an argument without undue interference, and question or refute the testimony or evidence, including the opportunity to confront and cross-examine adverse witnesses.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.7 § 2.18, eff. October 1, 1993.

12VAC30-110-320 Evidence

The rules of evidence shall not strictly apply. All relevant, nonrepetitive evidence may be admitted, but the probative weight of the evidence will be evaluated by the hearing officer.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.7 § 2.19, eff. October 1, 1993.

12VAC30-110-330 Record of hearing

All hearings shall be recorded either by court reporter, tape recorders, or whatever other means the agency deems appropriate. All exhibits accepted or rejected shall become part of the hearing record.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.7 § 2.20, eff. October 1, 1993.

12VAC30-110-340 Oath or affirmation

All witnesses shall testify under oath which shall be administered by the court reporter or the hearing officer, as delegated by the department's director.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.7 § 2.21, eff. October 1, 1993.

12VAC30-110-350 Dismissal of Request for Appeal

A. A Request for Appeal may be dismissed if:

1. The appellant or his representative withdraws the request via any of the methods in 12VAC30-110-130. For telephonic appeal withdrawals, the agency shall record the individual's statement and telephonic signature; or

2. The appellant or his representative fails to appear at the scheduled hearing without good cause and does not reply within 10 days after the hearing officer sends an inquiry as to whether the appellant wishes further action on the appeal.

B. Subsequent to the dismissal, the appellant shall receive the written order of dismissal via regular mail or electronic notification in accordance with the individual's election under 42 CFR 435.918(a).

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-04-8.7 § 1.11, eff. October 1, 1993; amended, Virginia Register Volume 31, Issue 16, eff. May 6, 2015; Volume 34, Issue 6, eff. December 13, 2017.

12VAC30-110-360 Post-hearing supplementation of the record

A. Medical assessment. Following a hearing, a hearing officer may order an independent medical assessment as described in 12VAC30-110-200.

B. Additional evidence. The hearing officer may leave the hearing record opened for a specified period of time in order to receive additional evidence or argument from the appellant. If the record indicates that evidence exists which was not presented by either party, with the appellant's permission, the hearing officer may attempt to secure such evidence.

C. Appellant's right to reconvene hearing or comment. If the hearing officer receives additional evidence from a person other than the appellant or his representative, the hearing officer shall send a copy of such evidence to the appellant and his representative and give the appellant the opportunity to comment on such evidence in writing or to reconvene the hearing to respond to such evidence.

D. Any additional evidence received will become a part of the hearing record, but the hearing officer must determine whether or not it will be used in making the decision.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.7 § 2.23, eff. October 1, 1993.

12VAC30-110-370 Final decision and transmission of the hearing record

A. After conducting the hearing, reviewing the record, and deciding questions of law, the hearing officer shall issue a written final decision based upon the evidence and testimony presented. The hearing officer's final decision shall be considered as the agency's final administrative action pursuant to 42 CFR 431.244(f). The final decision shall include:

1. A description of the procedural development of the case;

2. Findings of fact that identify supporting evidence;

3. Conclusions of law that identify supporting regulations and law;

4. Conclusions and reasoning;

5. The specific action to be taken by the agency to implement the decision;

6. The deadline date by which further action must be taken; and

7. A cover letter stating that the hearing officer's decision is final, and stating that the final decision may be appealed directly to circuit court as provided in 12VAC30-110-40.

B. The hearing record shall be forwarded to the appellant and the appellant's authorized representative with the final decision.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.7 § 2.24, eff. October 1, 1993; amended, Virginia Register Volume 10, Issue 23, eff. October 1, 1994; Volume 11, Issue 17, eff. June 15, 1995; Volume 22, Issue 26, eff. November 20, 2006; Volume 25, Issue 14, eff. April 15, 2009; Volume 40, Issue 22, eff. August 1, 2024.

12VAC30-110-380 (Repealed.)

History

• Historical Notes: Derived from VR460-04-8.7 § 2.25, eff. October 1, 1993; repealed, Virginia Register Volume 25, Issue 14, eff. April 15, 2009.

12VAC30-110-390 (Repealed.)

Historical Notes

Derived from VR460-04-8.7 §§ 3.1 through 3.22 eff. October 1, 1993; repealed, Virginia Register Volume 11, Issue 17, eff. June 15, 1995.

12VAC30-110-610 Definitions

For those medically needy persons whose eligibility for medical assistance is required by federal law to be dependent on the budget methodology for Aid to Dependent Children, a home means the house and lot used as the principal residence and all contiguous property.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-2.6105 § 1, eff. June 16, 1993.

12VAC30-110-620 Availability of real or personal property

Real or personal property of a spouse is considered available to a spouse if they are living together. Real or personal property of a parent living in the home is considered available to his child or children, except property owned by an SSI recipient is not considered available to his children in determining their eligibility for Medicaid.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-2.6105 § 2, eff. June 16, 1993.

12VAC30-110-630 Income-producing real property other than the home for aged, blind and disabled individuals

A. Income-producing real property other than the home does not affect eligibility if:

1. It is used in a trade or business or is otherwise income producing;

2. The equity value (current market value less the.balance of any recorded liens against the property) of the property does not exceed $6,000; and

3. The property produces a net annual income to the individual of at least 6.0% of the property's equity value.

B. If the property produces less than the 6.0% net annual income, it may be excluded if its equity value does not exceed $6,000 and it is used in a business or nonbusiness income-producing activity, and the following conditions are met:

1. Unusual or adverse circumstances, such as a fire, street repair in front of a store, or natural disaster, cause a temporary reduction in the rate of return;

2. The property usually produces net annual income of at least 6.0% of the equity value; and

3. The individual expects the property to again produce income at the 6.0% rate of return within 18 months of the end of the calendar year in which the unusual incident caused the reduction in the rate of return. When the property must be counted because the equity exceeds $6,000 or because the net annual return to the individual is less than 6.0% or equity, the individual's equity over $6,000 in the property is a countable resource.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-2.6105 § 3, eff. June 16, 1993; amended, Virginia Register Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-110-640 Income

For the purposes of determining eligibility, income is defined as the receipt of any property or services which an individual can apply, either directly or by sale or conversion, to meet the individual's basic needs for food, shelter, and clothing. Income is either earned (payment received by the individual for services performed as an employee, or as a result of being self-employed) or unearned (includes pensions, benefits, prizes, inheritances, gifts, dividends, support and maintenance).

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-2.6105 § 4, eff. June 16, 1993.

12VAC30-110-650 Deeming of income and resources; responsibility of spouses

A. If an individual and the spouse apply or are eligible for Medicaid as aged, blind, or disabled, and they cease to live together (separate), their income and resources are considered available (deemed) to each other for the time periods specified in this section. After the appropriate time period, income or resources actually contributed by the separated spouse to the individual are counted in determining the individual's eligibility.

B. Reserved.

C. If spouses separate for any reason other than institutionalization, their income and resources are deemed to each other during the month in which they cease to live together. When spouses cease to live together, their income and resources cease to be deemed to each other beginning the first month following the month the couple ceases to live together.

D. If only one spouse in a couple applies for Medicaid or only one meets the aged, blind, or disabled requirement, or if both spouses apply and are not eligible as a couple and they separate, only the income and resources of the separated spouse that are actually contributed to the individual are counted as available to the individual beginning with the month after the month in which they cease to live together.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-2.6105 § 5, eff. June 16, 1993; amended, Virginia Register Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-110-660 Deeming of income and resources; responsibility of parents for blind or disabled children

A. If the blind or disabled child is living in the same household with a parent and is (i) under age 18 or (ii) under age 21 and regularly attending a school, college, university or is receiving technical training designed to prepare him for gainful employment, the parents' income and resources are deemed available to the child.

B. Only the parent's income and resources which remain, after deducting appropriate disregards and amounts for the maintenance needs of the parents and other dependents in the household, are deemed as resources and unearned income available to the blind or disabled child.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-2.6105 § 6, eff. June 16, 1993; amended, Virginia Register Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-110-670 Aid to Dependent Children (ADC) Related Medically Needy Individuals

A. Reserved.

B. Personal property.

1. Automobiles. The policy in § 4 of Supplement 8b (was Supplement 12) to Attachment 2.6-A of the State Plan (12VAC30-40-290) applies.

2. Life insurance. The policy in § 5 of Supplement 8b (was Supplement 12) to Attachment 2.6-A of the State Plan (12VAC30-40-290) applies.

3. Burial plots. The market value of burial plots owned by any member of the family unit are not counted toward the medical resource limit for the family.

4. Prepaid burial plans are counted as resources, except for the amounts of such funeral agreements that are disregarded under the Virginia ADC cash assistance program.

5. Assets which can be liquidated such as cash, bank accounts, stocks, bonds, and securities, are counted as resources.

C. The income eligibility determination methodology of the Virginia ADC cash assistance program applies.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-2.6105 § 7, eff. June 16, 1993; amended, Virginia Register Volume 17, Issue 13, eff. April 11, 2001; Volume 25, Issue 14, eff. April 15, 2009.

12VAC30-110-680 SSI

A SSI recipient who has transferred or given away property to become or remain eligible for SSI or Medicaid and who has not received compensation in return for the property approximating the tax assessed value of the property is ineligible for long-term care (see 12VAC30-40-300).

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-2.6105 § 8, eff. June 16, 1993; amended, Virginia Register Volume 25, Issue 14, eff. April 15, 2009.

12VAC30-110-690 Imposition of lien

No lien may be imposed or any encumbrance placed upon any property, real or personal, owned by a recipient of medical assistance except pursuant to a court judgment on account of benefits incorrectly paid.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-2.6105 § 9, eff. June 16, 1993.

12VAC30-110-700 Transfer of assets

A. Certain term life insurance policies purchased after April 7, 1993. When making eligibility determinations for institutional or community-based care to be paid for by the department, the department shall consider as an uncompensated transfer all resources that are used by an applicant to purchase any term life insurance policy that does not have a benefit payable at death that will equal or exceed twice the sum of all premiums paid for such policy if the policy was purchased within 30 months prior to the date of application for medical assistance unless the policy was purchased to fund a funeral in accordance with § 54.1-2820 of the Code of Virginia.

The purpose of the policy shall be determined by reviewing the policy. If the policy language specifies that the death benefits shall be used to purchase burial space items or funeral services then the purchase of such policy shall not be considered a transfer of assets; however, the Department of Medical Assistance Services shall initiate action to recover from the beneficiary the amount of any benefit paid under the provisions of the policy which exceed the actual expense of the funeral and burial of the insured.

B. Inter vivos trusts.

1. Assets of inter vivos trusts available. When determining eligibility for medical assistance, the assets of any inter vivos trust, both principal and interest, shall be considered available to the grantor who is an applicant for or recipient of medical assistance without regard to any provision of the trust which provides directly or indirectly for the suspension, termination, or diversion of the principal, income or other beneficial interest of the grantor if he should apply for medical assistance or if he should require medical, hospital or nursing care or long-term custodial, nursing or medical care. The amount of principal or interest to be considered available shall be that amount of income or principal of the trust to which the grantor is entitled if no application for assistance had been made except for trusts created prior to August 11, 1993.

2. Trusts created prior to August 11, 1993. Up to $25,000 of the corpus of an inter vivos trust created prior to August 11, 1993, shall not be a countable asset. If the grantor created more than one such trust, the corpora of the trusts shall be added together. If the sum of the corpora is less than $25,000, no assets from any of the trusts shall be considered available. If the sum of the corpora exceeds $25,000, then the total amount of the corpora less $25,000 is a countable asset. In determining the amount of each trust to exempt, the $25,000 exemption shall be prorated among the trusts.

In applying this section, if, prior to August 11, 1993, the grantor has made transfers for an uncompensated value as defined in § 20-88.02 of the Code of Virginia within 30 months of applying for Medicaid and no payments were ordered pursuant to subsection D of that section, then no $25,000 exemption shall be granted.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-2.6108 § 1, eff. July 1, 1993; amended, Virginia Register Volume 17, Issue 13, eff. April 11, 2001; Volume 25, Issue 14, eff. April 15, 2009.

12VAC30-110-710 Undue hardship; transfer of resources

A. Undue hardship exists when the department determines that the application of the transfer of assets provisions would deprive the individual of medical care such that his health or his life would be endangered or would deprive the individual of food, clothing, shelter or other necessities of life.

B. When determining the eligibility of an individual who has transferred resources without receiving adequate compensation, the individual must be notified:

1. That an undue hardship can be claimed, the process for seeking an exception from the transfer of assets provisions and the time frame making determinations of whether an undue hardship exists;

a. That written documentation must be provided to substantiate the circumstances of the transfer and the claim of undue hardship.

b. That written documentation must be provided to document that the resources transferred without adequate compensation cannot be recovered.

c. That written documentation must clearly substantiate the immediate adverse impact of the denial of Medicaid coverage of long-term care services due to the uncompensated transfer and would result in the individual being removed from the institution or unable to receive life sustaining medical care, food, clothing, shelter or other necessities of life.

2. That a denial of a claim for undue hardship may be appealed in accordance with the provisions of 12VAC30-110.

C. A hardship waiver may be requested by:

1.The applicant for, or recipient of, medical assistance services;

2.The applicant or recipient's spouse, legal guardian, power-of-attorney or person who has been authorized in writing by the applicant or recipient to act on his behalf; or

3. With the written consent of the individual or his personal representative, the nursing facility in which the institutionalized individual is residing.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-2.6109 § 1, eff. October 1, 1991; amended, Virginia Register Volume 17, Issue 13, eff. April 11, 2001; Volume 22, Issue 23, eff. August 23, 2006.

12VAC30-110-720 Definitions

The following words and terms when used in this part shall have the following meanings unless the context clearly indicates otherwise:

"Acceptable medical evidence" means either (i) certification by a nursing home preadmission screening committee; or (ii) certification by the individual's attending physician.

"Actual monthly expenses" means the total of:

1. Rent or mortgage, including interest and principal;

2. Taxes and insurance;

3. Any maintenance charge for a condominium or cooperative; and

4. The utility standard deduction under the Food Stamp Program that would be appropriate to the number of persons living in the community spouse's household, if utilities are not included in the rent or maintenance charge.

"Applicable percent" means that percentage as defined in § 1924(d)(3)(B) of the Social Security Act.

"As soon as practicable" (as it relates to transfer of resources from the institutionalized spouse to the community spouse for the purpose of the community spouse resource allowance) means within 90 days from the date the local agency takes action to approve the institutionalized spouse's initial eligibility for medical assistance long-term care services when the institutionalized spouse agrees to transfer resources to the community spouse.

"At the beginning of the first continuous period of institutionalization" means the first calendar month of a continuous period of institutionalization in a medical institution or of receipt of a Medicaid community-based care waiver service or hospice.

"Community spouse" means a person who is married to an institutionalized spouse and is not an inpatient at a medical institution or nursing facility.

"Community spouse monthly income allowance" means an amount by which the minimum monthly maintenance needs allowance exceeds the amount of monthly income otherwise available to the community spouse.

"Community spouse resource allowance" means the amount of the resources in the institutionalized spouse's name that can be transferred to the community spouse to bring the resources in the community spouse's name up to the protected resource amount.

"Continuous period of institutionalization" means 30 consecutive days of institutional care in a medical institution or nursing facility, or 30 consecutive days of receipt of Medicaid waiver or hospice services, or 30 consecutive days of a combination of institutional care and waiver and hospice services. Continuity is broken only by 30 or more days absence from a medical institution or 30 or more days of nonreceipt of waiver services.

"Couple's countable resources" means all of the couple's nonexcluded resources regardless of state laws relating to community property or division of marital property. For purposes of determining the combined and separate resources of the institutionalized and community spouses when determining the institutionalized spouse's eligibility, the couple's home, contiguous property, household goods, and one automobile are excluded.

"Department" means the Department of Medical Assistance Services.

"Dependent child" means a child younger than 21 years of age and a child 21 years of age or older, of either spouse, who lives with the community spouse and who may be claimed as a dependent by either member of the couple for tax purposes pursuant to the Internal Revenue Code.

"Dependent family member" means a parent, minor child, dependent child, or dependent sibling, including half brothers and half sisters and siblings gained through adoption, of either member of a couple who resides with the community spouse and who may be claimed as a dependent by either member of the couple for tax purposes pursuant to the Internal Revenue Code.

"Exceptional circumstances resulting in significant financial duress" means circumstances other than those taken into account in establishing the spousal maintenance allowance for which the community spouse incurs expenses in amounts that the community spouse cannot be expected to pay from the spousal maintenance allowance or from amounts held in the community spouse resource allowance.

"Excess shelter allowance" means the amount by which the actual monthly expense of maintaining the community spouse's residence plus the standard utility allowance exceeds the excess shelter standard.

"Excess shelter standard" means 30% of the monthly maintenance needs standard.

"Family member's income allowance" means an allowance for each dependent family member residing with the community spouse. The family member's income allowance is equal to one-third of the amount by which the monthly maintenance needs standard exceeds the family member's income.

"Federal Poverty Level" or "FPL" means the annual Federal Poverty Level as computed by the Office of Management and Budget and published in the Federal Register.

"First continuous period of institutionalization" means the first day of the first month of the first continuous period of institutionalization, which began on or after September 30, 1989.

"Initial eligibility determination" means:

1. An eligibility determination made in conjunction with a medical assistance application filed during an individual's most recent continuous period of institutionalization; or

2. The initial redetermination of eligibility for a medical assistance eligible institutionalized spouse after being admitted to an institution or receiving medical assistance community-based care waiver services.

"Initial redetermination" means the first redetermination of eligibility for a medical assistance eligible spouse that is regularly scheduled, or that is made necessary by a change in the individual's circumstances.

"Institutionalized spouse" means an individual who is an inpatient at a medical institution, who is receiving medical assistance community-based care waiver services, or who has elected hospice services, and who is likely to remain in such facility or to receive waiver or hospice services for at least 30 consecutive days, and who has a spouse who is not in a medical institution or nursing facility.

"Likely to remain in an institution" means a reasonable expectation based on acceptable medical evidence that an individual will be in a medical institution or will receive medical assistance waiver or hospice services for 30 consecutive days, even if receipt of institutional care or waiver or hospice services actually terminates in less than 30 days. Individuals who have been screened and approved for medical assistance community-based waiver services or who have elected hospice services shall be considered likely to remain in an institution.

"Maximum monthly maintenance needs standard" is the upper limit, i.e., cap established under § 1924(d)(3)(C) of the Social Security Act.

"Maximum spousal resource standard" means the maximum amount of the couple's combined countable resources established for a community spouse to maintain himself in the community calculated in accordance with § 1924(f)(2)(A)(ii)(II) of the Social Security Act. This amount increases annually by the same percentage as the percentage increase in the Consumer Price Index for all urban consumers between September 1988 and the September before the calendar year involved as required in § 1924(g) of the Social Security Act.

"Medical institution" or "nursing facility" means hospitals and nursing facilities, including an intermediate care facility for individuals with intellectual disabilities (ICF/ID), consistent with the definitions of such institutions found in the Code of Federal Regulations at 42 CFR 435.1009, 42 CFR 435.1010, 42 CFR 440.40, and 42 CFR 440.150 and which are authorized under Virginia law to provide medical care.

"Minimum monthly maintenance needs allowance" means the monthly maintenance needs standard, plus an excess shelter allowance, if applicable, not to exceed the maximum monthly maintenance needs standard. The minimum monthly maintenance needs allowance is the amount to which a community spouse's income is compared in order to determine the community spouse's monthly income allowance.

"Minor" means a child younger than 21 years of age, of either spouse, who lives with the community spouse.

"Monthly maintenance needs standard" means an amount no less than 150% of 1/12 of the Federal Poverty Level for a family of two in effect on July 1 of each year.

"Other family members" means dependent children and dependent parents and siblings of either member of a couple who reside with the community spouse.

"Otherwise available income or resources" means income and resources that are legally available to the community spouse and to which the community spouse has access and control.

"Promptly assess resources" means within 45 days of the request for resource assessment unless the delay is due to nonreceipt of documentation or verification, if required, from the applicant or from a third party.

"Protected period" means a period of time, not to exceed 90 days after an initial determination of medical assistance eligibility. During the protected period, the amount of the community spouse resource allowance will be excluded from the institutionalized spouse's countable resources if the institutionalized spouse expressly indicates his intention to transfer resources to the community spouse.

"Resource assessment" means a computation, completed by request or upon medical assistance application, of a couple's combined countable resources at the beginning of the first continuous period of institutionalization of the institutionalized spouse beginning on or after September 30, 1989.

"Resources" means real and personal property owned by a medical assistance applicant or his spouse. Resources do not include resources excluded under subsection (a) or (d) of § 1613 of the Social Security Act and resources that would be excluded under § 1613(a)(2)(A) but for the limitation on total value described in such section.

"Significant financial duress" means, but is not limited to, threatened loss of basic shelter, food, or medically necessary health care or the financial burden of caring for a disabled child, sibling, or other immediate relative.

"Spousal protected resource amount" means (at the time of medical assistance application as an institutionalized spouse) the greater of: (i) the spousal resource standard in effect at the time of application; (ii) the spousal share, not to exceed the maximum spousal resource standard in effect at the time of application; (iii) the amount actually transferred to the community spouse by the institutionalized spouse pursuant to a court spousal support order; or (iv) the amount of resources designated by a department hearing officer.

"Spousal resource standard" means the minimum amount of a couple's combined countable resources calculated in accordance with § 1924(f)(2)(A)(i) of the Social Security Act necessary for the community spouse to maintain himself in the community. The amount increases each calendar year after 1989 by the same percentage increase as in the Consumer Price Index as required by § 1924(g) of the Social Security Act.

"Spousal share" means half of the couple's total countable resources at the beginning of the first continuous period of institutionalization as determined by a resource assessment.

"Spouse" means a person who is legally married to another person under Virginia law.

"State Plan" means the State Plan for Medical Assistance.

"Undue hardship" means that the provisions listed under 12VAC30-110-831 have been met. The absence of an undue hardship provision would result in the institutionalized spouse being ineligible for Medicaid payment of long-term care services and unable to purchase life-sustaining medical care.

"Waiver services" means medical assistance reimbursed home or community-based services covered under a § 1915(c) waiver approved by the Secretary of the U.S. Department of Health and Human Services.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.6 § 1.1, eff. October 1, 1991; amended, Virginia Register Volume 12, Issue 9, eff. March 1, 1996; Volume 17, Issue 13, eff. April 11, 2001; Volume 18, Issue 21, eff. August 1, 2002; Volume 25, Issue 14, eff. April 15, 2009; Volume 42, Issue 11, eff. February 11, 2026.

Article 1 General

12VAC30-110-730 Applicability

Subpart II Resource Assessments And Eligibility

Article 1 General

A. These income and resource regulations shall apply to a married institutionalized individual who:

1. Was admitted to a medical institution, medical assistance community-based waiver service or hospice service on or after September 30, 1989, and has been continuously institutionalized since admission; and

2. Has a community spouse.

B. In determining the income and resources of an institutionalized spouse as defined in 12VAC30-110-720, the provisions of 12VAC30-110-720 through 12VAC30-110-1010 supercede any other provision of medical assistance regulations that is inconsistent with them.

C. Except as this section specifically provides, this section does not apply to:

1. The determination of what constitutes income or resources; or

2. The methodology and standards for determining and evaluating income and resources.

D. These rules shall cease to apply to determinations of medical assistance eligibility or to post-eligibility determinations of patient pay in the first calendar month following changes in circumstances resulting in an institutionalized spouse no longer being institutionalized or no longer having a community spouse.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.6 § 2.1, eff. October 1, 1991; amended, Virginia Register Volume 12, Issue 9, eff. March 1, 1996; Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-110-740 (Repealed.)

Historical Notes

Derived from VR460-04-8.6 § 2.2, eff. October 1, 1991; repealed, Virginia Register Volume 17, Issue 13, eff. April 11, 2001.

Article 2 Assessments of Couple's Resources

12VAC30-110-741 Resource assessment required

Article 2 Assessments of Couple's Resources

A resource assessment shall be completed by the entity determining medical assistance eligibility on all medical assistance applications for married institutionalized individuals who have a community spouse. If an applicant alleges that his marital status is unknown, it shall be his responsibility to establish his marital status. It shall be the applicant's responsibility to locate his community spouse. If attempts to establish marital status or locate the separated spouse are unsuccessful or the community spouse does not provide the required information necessary to complete the resource assessment, the medical assistance eligibility application will be denied due to inability to complete the required resource assessment, unless undue hardship, as defined in 12VAC30-110-831, is met.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 13, eff. April 11, 2001; amended, Virginia Register Volume 18, Issue 21, eff. August 1, 2002; Volume 25, Issue 14, eff. April 15, 2009.

12VAC30-110-744 Resource assessment initiated

A resource assessment shall be initiated by an entity determining medical assistance eligibility:

1. Upon request by either spouse of a couple, or a representative acting on behalf of either spouse, at the beginning of the first continuous period of institutionalization when (i) all relevant documentation of resources has been received and (ii) upon payment of a fee, if any, the amount of which is determined by the entity determining medical assistance eligibility, if the institutionalized spouse has not applied for medical assistance; or

2. Upon application for medical assistance by or on behalf of a married institutionalized individual who has a community spouse.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-110-747 Total resources

There shall be computed as of the beginning of the first continuous period of institutionalization of the institutional spouse, the total value of the couple's resources to the extent either the institutionalized spouse or the community spouse has an ownership interest.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-110-750 Notification of documentation required

When a resource assessment is initiated, the Department of Social Services shall notify the applicant of all relevant documentation required to be submitted for the assessment.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.6 § 2.3, eff. October 1, 1991.

12VAC30-110-751 Spousal share

The total value of the couple's combined resources shall be divided by two to determine the spousal share.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-110-760 Failure to provide documentation

If an applicant fails to provide requested documentation necessary to complete the required resource assessment within 45 days of receipt of notification sent pursuant to 12VAC30-110-750, the department shall notify him that the assessment cannot be completed.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.6 § 2.4, eff. October 1, 1991; amended, Virginia Register Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-110-770 Notification of assessment and appeal rights

The department shall provide each member of a couple with copies of the completed resource assessment and the documentation used to produce it. The department shall notify the couple of the procedure by which to appeal the resource assessment.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.6 § 2.5, eff. October 1, 1991.

12VAC30-110-780 Appeal of resource assessment

A. Not accompanied by a medical assistance application. If the resource assessment was conducted without a concurrent medical assistance application, an ineligible spouse may not appeal the assessment pursuant to the existing Client Appeals regulations (Part I (12VAC30-110-10 et seq.) of this chapter); however, an ineligible spouse will have an opportunity to appeal assessment findings if and when his institutionalized spouse applies for medical assistance.

B. Medical assistance application. A resource assessment which was conducted pursuant to a medical assistance application submitted by the institutionalized spouse may be appealed by either spouse pursuant to existing Client Appeals regulations (Part I (12VAC30-110-10 et seq.) of this chapter).

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.6 § 2.6, eff. October 1, 1991; amended, Virginia Register Volume 12, Issue 9, eff. March 1, 1996; Volume 17, Issue 13, eff. April 11, 2001.

Article 3 Resource Eligibility Determinations for Institutionalized Spouses

12VAC30-110-790 Applicability

Article 3 Resource Eligibility Determinations for Institutionalized Spouses

This article shall be used to determine a married institutionalized individual's initial and continuing medical assistance eligibility for his current continuous period of institutionalization.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.6 § 2.7, eff. October 1, 1991; amended, Virginia Register Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-110-800 Initial eligibility determinations

An institutionalized spouse meets the medical assistance resource eligibility requirements if the difference between the couple's total countable resources at the time of application and the spousal protected resource amount, as defined in 12VAC30-110-720, is equal to or less than the appropriate medical assistance resource limit for one person.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.6 § 2.8, eff. October 1, 1991; amended, Virginia Register Volume 12, Issue 9, eff. March 1, 1996; Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-110-810 Initial determinations of ineligibility

When the institutionalized spouse has countable resources in excess of the medical assistance resource limit for one person, the application for medical assistance shall be denied.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.6 § 2.9, eff. October 1, 1991; amended, Virginia Register Volume 12, Issue 9, eff. March 1, 1996; Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-110-813 Attribution of resources at the time of initial eligibility determination

In determining the countable resources of an institutionalized spouse at the time of application, regardless of any state laws relating to community property or division of marital property, all resources held by either the institutionalized spouse, community spouse, or both, shall be considered available to the institutionalized spouse but only to the extent that the amount of such resources exceeds the spousal protected resource amount calculated in accordance with § 1924(f)(2)(A) of the Act.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-110-815 Spousal protected resource amounts

In the initial determination of eligibility, there shall be deducted from the couple's total combined countable resources in the application month a spousal protected resource amount.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-110-820 (Repealed.)

Historical Notes

Derived from VR460-04-8.6 § 2.10, eff. October 1, 1991; amended, Virginia Register Volume 12, Issue 9, eff. March 1, 1996; repealed, Virginia Register Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-110-830 Additional resource exclusions

If an institutionalized spouse has resources exceeding the appropriate medical assistance resource limit for one person, the following are deducted from his resources for the purpose of establishing eligibility, as appropriate:

1. The amount of resources which the institutionalized spouse has transferred to the community spouse or to other dependents pursuant to a court support order;

2. An amount necessary to make the individual eligible if the department determines that the denial of medical assistance would create undue hardship as defined in 12VAC30-110-720.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.6 § 2.11, eff. October 1, 1991; amended, Virginia Register Volume 12, Issue 9, eff. March 1, 1996; Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-110-831 Undue hardship

A. Undue hardship can be claimed when the value of resources owned on the first day of the first month of the first continuous period of institutionalization cannot be verified after both spouses have exhausted all avenues to document the value of the resources owned on that day. When hardship is claimed, the spousal resource standard shall be used as a substitute for the spousal share when calculating the spousal protected resource amount.

B. Undue hardship can also be claimed if each of the following criteria are met:

1. The applicant establishes by affidavit specific facts sufficient to demonstrate:

a. That he has taken all steps reasonable under the circumstances to locate the spouse, to obtain relevant information about the resources of the spouse, and to obtain financial support from the spouse; and

b. That he has been unsuccessful in doing so.

Absent extraordinary circumstances, determined by DMAS, the requirements of subdivision 1 a of this subsection cannot be met unless the applicant and spouse have lived separate and apart without cohabitation and without interruption for at least 36 months.

2. Upon such investigation as DMAS may undertake, no facts are revealed that refute the statements contained in the applicant's affidavit, as required by subdivision 1 of this subsection;

3. The applicant has assigned to DMAS, to the full extent allowed by law, all claims he may have to financial support from the spouse; and

4. The applicant cooperates with DMAS in any effort undertaken or requested by DMAS to locate the spouse, to obtain information about the spouse's resources or to obtain financial support from the spouse.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 21, eff. August 1, 2002.

12VAC30-110-840 Separate treatment of resources after eligibility for benefits established

Beginning with the first calendar month following the date of the initial determination of eligibility, unless 12VAC30-110-900 applies, the institutional spouse's continuing eligibility shall be determined based solely on resources held in his name. The resources owned by the community spouse shall not be deemed available to the institutional spouse in the month following the initial month of ongoing eligibility.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.6 § 2.12, eff. October 1, 1991; amended, Virginia Register Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-110-850 Post-eligibility resource transfers

After an initial determination of eligibility and during the protected period specified in 12VAC30-110-860, an institutionalized spouse may transfer to his community spouse resources equal to the community spouse resource allowance which are not already titled to the community spouse. Any resource owned by the institutionalized spouse which is not transferred pursuant to this section and which the institutionalized spouse does not actually make available to meet the community spouse's needs shall be deemed available to the institutional spouse for the purpose of determining continuing eligibility.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.6 § 2.13, eff. October 1, 1991; amended, Virginia Register Volume 12, Issue 9, eff. March 1, 1996; Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-110-853 Community spouse resource allowance

The community spouse resource allowance shall be calculated by determining the amount by which the greatest of:

1. The spousal resource standard;

2. The spousal share not to exceed the maximum spousal resource standard;

3. An amount established by a department hearing officer; or

4. An amount actually transferred from the institutionalized spouse to the community spouse under a court spousal support order exceeds the amount of resources otherwise available to the community spouse (determined without regard to such an allowance). If the community spouse has title to resources equal to or exceeding his spousal protected resource amount, he shall not be entitled to a community spouse resource allowance.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-110-856 Revisions to the community spouse resource allowance

For the purposes of this article, a community spouse resource allowance may be revised if:

1. A department hearing officer determines on appeal that the income generated from the community spouse resource allowance as originally calculated pursuant to 12VAC30-110-853 is inadequate to raise the community spouse's income to the minimum amount to be deducted as a maintenance allowance in the post-eligibility determination made pursuant to Article 4 (12VAC30-110-920 et seq.) of this subpart;

2. A department hearing officer determines on appeal that the original calculation was incorrect;

3. The department determines that the original information with which the spousal share was calculated was incorrect; or

4. An institutionalized spouse transfers resources to a community spouse pursuant to a court order for spousal support.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-110-860 Protected periods of eligibility

Subject to 12VAC30-110-870, for 90 days after an initial determination of eligibility, resources in the institutionalized spouse's name necessary to meet the community spouse resource allowance shall be disregarded in determining continued eligibility of the institutionalized spouse. An institutionalized spouse's eligibility shall be protected to allow him time to legally transfer resources pursuant to 12VAC30-110-850 if the institutionalized spouse expressly indicates in writing his intention to effect such a transfer. Absent such an expression of intent, the protected period will not extend beyond the end of the month in which eligibility is being determined. The 90-day protected period shall begin with the date the agency takes action to approve the institutionalized spouse's initial eligibility for medical assistance for institutional, waiver, or hospice services. No extension of the protected period shall be permitted.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.6 § 2.14, eff. October 1, 1991; amended, Virginia Register Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-110-870 Exception to protected period of eligibility

If, at the time of an initial determination of eligibility, a community spouse has title to resources equal to or exceeding his spousal protected resource amount, no protected period of eligibility shall exist.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.6 § 2.15, eff. October 1, 1991; amended, Virginia Register Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-110-880 Additional resources acquired during protected period of eligibility

If an institutionalized spouse obtains additional resources during a protected period of eligibility, the additional resources shall be exempt during the protected period if:

1. The new resources combined with other resources that the institutionalized spouse intends to retain do not exceed the appropriate medical assistance resource limit for one person, or

2. The institutionalized spouse intends to transfer the new resources to the community spouse during the protected period of eligibility, and the total resources to be transferred do not exceed the community spouse resource allowance.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.6 § 2.16, eff. October 1, 1991; amended, Virginia Register Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-110-890 (Repealed.)

Historical Notes

Derived from VR460-04-8.6 § 2.17, eff. October 1, 1991; amended, Virginia Register Volume 12, Issue 9, eff. March 1, 1996; repealed, Virginia Register Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-110-900 Resource eligibility determinations in retroactive months

A. First application for medical assistance. In each of the three months preceding an institutionalized spouse's first application for medical assistance in the current continuous period of institutionalization for which resource eligibility is to be determined, the community spouse protected resource amount shall be deducted from the couple's combined countable resources held on the first moment of the first day of each retroactive month.

B. Later applications for medical assistance when medical assistance eligibility was established previously. If an individual established medical assistance eligibility as an institutionalized spouse during a period of institutionalization that began on or after September 30, 1989, regardless of whether the period of institutionalization is the same continuous period covered by the previous application, resources owned by the community spouse are not considered in determining the institutionalized spouse's medical assistance eligibility.

C. Later applications for medical assistance when Virginia medical assistance eligibility was not previously established. Regardless of whether previous medical assistance applications have been submitted, if an individual has never established medical assistance eligibility as an institutionalized spouse, the application shall be treated in the same manner as the first application.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.6 § 2.18, eff. October 1, 1991; amended, Virginia Register Volume 12, Issue 9, eff. March 1, 1996; Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-110-910 Eligibility for community spouses and other family members

If a community spouse or other family member applies for medical assistance eligibility on his own behalf, these eligibility regulations will not be used to determine his eligibility for medical assistance.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.6 § 2.19, eff. October 1, 1991; amended, Virginia Register Volume 17, Issue 13, eff. April 11, 2001.

Article 4 Income

12VAC30-110-920 Applicability

Article 4 Income

This article shall apply only to the institutional spouse's eligibility for medical assistance.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.6 § 3.1, eff. October 1, 1991; amended, Virginia Register Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-110-921 Treatment of income

During any month in which an institutionalized spouse is an inpatient in a medical institution, is receiving medical assistance community-based waiver services or has elected hospice services, no income of the community spouse shall be deemed available to the institutionalized spouse except as provided in 12VAC30-110-930.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-110-930 Determining income

A couple's income shall be determined as follows, without regard to state laws governing community property or division of marital property:

1. Income from nontrust property. Unless a department hearing officer determines that the institutionalized spouse has proven to the contrary by a preponderance of the evidence:

a. Income paid to one spouse belongs to that spouse;

b. Each spouse owns one-half of all income paid to both spouses jointly;

c. Each spouse owns one-half of any income which has no instrument establishing ownership;

d. Income paid in the name of either spouse, or both spouses and at least one other party, shall be considered available to each spouse in a proportionate share. When income is paid to both spouses and each spouse's individual interest is not specified, one-half of their joint interest in the income shall be considered as available to each spouse.

2. Income from trust property. Ownership of trust property shall be determined pursuant to the State Plan, except as follows:

a. Each member of a couple owns the income from trust property in accordance with the trust's specific terms.

b. If a trust instrument is not specific as to the ownership interest in income, ownership shall be determined as follows:

(1) Income paid to one spouse belongs to that spouse;

(2) One-half income paid to both spouses shall be considered available to each spouse;

(3) Income from a trust paid in the name of either spouse, or both spouses and at least one other party, shall be considered available to each spouse in a proportionate share. When income from a trust is paid to both spouses and each spouse's individual interest is not specified, consider one-half of their joint interest in the income as available to each spouse.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.6 § 3.2, eff. October 1, 1991; amended, Virginia Register Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-110-940 Applicability

Subpart III Post-Eligibility Process

After an institutionalized spouse is determined or redetermined to be eligible for medical assistance, and after all appropriate deductions pursuant to 12VAC30-110-950 through 12VAC30-110-970 have been made from an institutionalized spouse's gross monthly income pursuant to this subpart, the balance shall constitute the maximum amount the institutionalized spouse shall pay for medical assistance-covered institutional or waiver services.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.6 § 3.3, eff. October 1, 1991; amended, Virginia Register Volume 12, Issue 9, eff. March 1, 1996; Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-110-950 Mandatory deductions from institutionalized spouse's income

The following amounts shall be deducted from the institutionalized spouse's gross monthly income:

1. A personal needs allowance of $40;

2. The community spouse monthly income allowance as calculated pursuant to 12VAC30-110-960;

3. The family maintenance allowance, if any, as calculated pursuant to 12VAC30-110-970; and

4. Incurred medical and remedial care expenses recognized under state law, not covered under the State Plan and not subject to third party payment.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.6 § 3.4, eff. October 1, 1991; amended, Virginia Register Volume 12, Issue 9, eff. March 1, 1996; Volume 17, Issue 13, eff. April 11, 2001; Volume 23, Issue 18, eff. July 1, 2007.

12VAC30-110-960 Community spouse income allowance

A. Unless the exceptions in subsections B and C of this section apply, a community spouse monthly income allowance shall be deducted from the monthly income of the institutionalized spouse. The community spouse monthly income allowance shall be the amount by which the greater of:

1. The community spouse monthly maintenance needs standard plus the excess shelter allowance, if any; or

2. An amount determined necessary by a department hearing officer because of exceptional circumstances resulting in extreme financial duress;

exceeds the amount of monthly income otherwise available to the community spouse (determined without regard to such an allowance).

B. A community spouse monthly income allowance shall not be deducted from the income of the institutionalized spouse when the institutionalized spouse does not actually make an income allowance available to the community spouse.

C. If a court has entered an order against an institutionalized spouse for monthly income for the support of the community spouse, the community spouse monthly income allowance for the spouse shall be not less than the amount of the monthly income so ordered.

D. Application of "Income First" Rule to Revision of Community Spouse Resource Allowance. All income of the institutionalized spouse that could be made available to a community spouse, in accordance with the calculation of the community spouse monthly income allowance, must be made available before an amount of resources adequate to provide the difference between the minimum monthly maintenance needs allowance and all income available to the community spouse is allocated to the community spouse.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.6 § 3.5, eff. October 1, 1991; amended, Virginia Register Volume 12, Issue 9, eff. March 1, 1996; Volume 17, Issue 13, eff. April 11, 2001; Volume 22, Issue 23, eff. August 23, 2006.

12VAC30-110-970 Family members maintenance needs allowance

A. There shall be deducted from the institutionalized spouse's income an allowance for each dependent family member.

B. The amount deducted shall be an amount equal to 1/3 of the community spouse monthly maintenance needs standard, minus each family member's income.

C. This allowance is to be deducted regardless of whether the institutionalized spouse actually makes the allowance available to the family member.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.6 § 3.6, eff. October 1, 1991; amended, Virginia Register Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-110-980 Applicability, notices and regulatory authority

Subpart IV Appeals

A. The appeals process contained in this subpart shall apply to appeals of resource assessments, initial determinations and redeterminations of resources, and income amounts and allowances made in connection with applications for medical assistance benefits by spouses institutionalized for a continuous period on or after September 30, 1989, or receiving waiver or hospice services for a continuous period on or after September 30, 1989, pursuant to existing Client Appeals regulations (Part I (12VAC30-110-10 et seq.) of this chapter).

B. Written notices are to be provided to the institutionalized spouse and the community spouse advising them of:

1. Resource assessments;

2. The amounts deducted for spousal and family allowances used in the post-eligibility calculation; and

3. Their rights to appeal the amounts deducted in the calculations for determining the spousal and family allowances used in the post-eligibility calculation.

C. Hearings and appeals held pursuant to this subpart are consistent with regulations at 42 CFR Part 431, Subpart E.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.6 § 4.1, eff. October 1, 1991; amended, Virginia Register Volume 12, Issue 9, eff. March 1, 1996; Volume 17, Issue 13, eff. April 11, 2001; Volume 25, Issue 14, eff. April 15, 2009.

12VAC30-110-990 (Repealed.)

History

• Historical Notes: Derived from VR460-04-8.6 § 4.2, eff. October 1, 1991; amended, Virginia Register Volume 17, Issue 13, eff. April 11, 2001; repealed, Virginia Register Volume 25, Issue 14, eff. April 15, 2009.

12VAC30-110-1000 (Repealed.)

History

• Historical Notes: Derived from VR460-04-8.6 § 4.3, eff. October 1, 1991; amended, Virginia Register Volume 12, Issue 9, eff. March 1, 1996; repealed, Virginia Register Volume 25, Issue 14, eff. April 15, 2009.

12VAC30-110-1010 Hearing officer authority

Through the appeals process applicable as described in 12VAC30-110-980, hearing officers shall prescribe appropriate increases in income or resource allowances in the event they determine that exceptional circumstances exist which cause significant financial duress to the community spouse.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.6 § 4.4, eff. October 1, 1991; amended, Virginia Register Volume 12, Issue 9, eff. March 1, 1996; Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-110-1011 Appealable issues

Only the following issues shall be appealable under this section:

1. Spousal share determinations;

2. Initial resource eligibility determinations and redeterminations;

3. Spousal protected resource amounts;

4. Community spouse resource allowance;

5. Income eligibility determinations and redeterminations; and

6. Patient pay and income allowance calculations.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 13, eff. April 11, 2001.

12VAC30-110-1020 Definitions

"AFDC" means Aid to Families with Dependent Children.

"Applicable disregards" means the amounts that would be deducted in determining eligibility under AFDC for families and under SSI for aged, blind and disabled recipients.

"Available income" means the earned and unearned income used in determining the financial eligibility of a medically needy individual.

"Budget period" means a prospective period of time during which an individual's income is calculated to determine eligibility.

"Budget unit" means a subunit of the family unit which is used in calculating countable income and resources when deeming of income and resources between family members would violate the Social Security Act.

"Countable income" means, for the medically needy, the amount of an applicant's income measured against the medically needy income level (MNIL). Countable income is determined by deducting the following amounts from reported gross income:

1. For individuals under age 21 and caretaker relative, amounts that would be deducted in determining eligibility under the state's AFDC plan, except for those prohibited under Title XIX of the Social Security Act.

2. For aged, blind, or disabled individuals, amounts that would be deducted determining eligibility under SSI and (i) any SSI benefits, (ii) any auxiliary grant, and (iii) other deductions from income applied under the Medicaid plan. This figure is measured against the income level for Medicaid eligibility.

"Expenses covered in the plan" means expenses for services included in the State Plan for Medical Assistance including those that exceed agency limitations of amount, duration or scope of services.

"Expenses not covered in the plan" means expenses for necessary medical and remedial services recognized under State law but not covered under the State Plan for Medical Assistance.

"Excess countable income" means the amount of income to be applied toward incurred medical expenses and is determined by subtracting the MNIL from the countable income.

"Family unit" consists of all individuals listed on the application form as living in the household and among whom legal responsibility under state law exists.

"Financially responsible relative" means a spouse or parent whose income is actually used in determining eligibility.

"Incurred expenses" means medical or remedial services:

1. Which are recognized under state law;

2. Which are rendered to an individual, family, or financially responsible relative;

3. For which the individual is liable in the current accounting period or was liable in the three-month retroactive period; and

4. Which are not subject to payment by any liable third party.

An expense for medical or remedial service is an incurred expense from the beginning of the accounting period in which the liability arises until the end of the accounting period in which the liability is satisfied.

"Institutionalized individual" means an individual residing in a long-term care institution or covered under a home and community-based waiver for 30 consecutive days.

"Liable third party" means any individual, entity or program that is or may be liable to pay all or part of the cost of medical or remedial treatment for injury, disease, or disability of an applicant or recipient of Medicaid.

"Medically needy income level" or "MNIL" means the income standard established to determine the eligibility of medically needy individuals and families.

"Old bills" means medical or remedial care expenses incurred prior to the initial application month and application's retroactive period, and which were not deducted from (counted in) any previous spenddown that was met.

"Projected expenses" means expenses for services that have not yet been incurred but are reasonably expected to be.

"Service dates" means dates of incurred medical expenses.

"Spenddown" means the process through which countable income is compared to the MNIL for the budget period and incurred medical and remedial care expenses are deducted from income in excess of the MNIL.

"Spenddown liability" means amounts by which countable income exceeds MNIL for the budget period.

"SSI" means Supplemental Security Income.

"State or territorial public program" means a program that is operated (i.e. administratively controlled) by a state or territory (including a political subdivision thereof).

"State or territorially-financed program" means a state or territorial public program whose funding, except for deductibles and coinsurance amounts required from program beneficiaries, is either:

1. Appropriated by the state or territory directly to the administering agency, or

2. Transferred from another state or territorial public agency to the administering agency.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-10-8.2600 § 1, eff. April 30, 1995.

12VAC30-110-1030 Income eligibility

A. Individuals and families who otherwise meet the medically needy eligibility requirements, but who have income in excess of the medically needy limit, shall be ineligible for medical assistance unless the excess income is insufficient to meet the total cost of needed medical care and the cost of incurred medical or remedial care recognized under state law has been deducted from excess income.

B. Spenddown applies only to the medically needy. Individuals must meet the medically needy nonfinancial, property transfer and resource requirements in order to be placed on a spenddown.

C. An individual or family shall be determined to be income eligible when countable income is equal to or lower than the medically needy income level for the budget period or when countable income after deduction of specified medical and remedial care expenses is equal to or below the MNIL. Countable income shall be compared to the MNIL for the budget period and incurred medical and remedial care expenses shall be deducted from income in excess of the MNIL.

D. An applicant having income in excess of the MNIL shall be advised that medical expenses incurred prior to the month of application count toward meeting the spenddown if the following conditions are met:

1. The applicant is legally liable to pay the expense.

2. A claim for the expense was submitted to the liable third parties and the applicant provides evidence of the third parties' denial of payment or amount of payment made by the third parties for the expense. Only that portion of the expense which is the applicant's legal responsibility (not the liability of any third party) shall be deducted from countable income.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-10-8.2600 § 2, eff. April 30, 1995.

12VAC30-110-1040 Spenddown calculation

A. When countable income exceeds the Medically Needy Income Level (MNIL) for the budget period, certain medical and remedial care expenses incurred by an individual, family or financially responsible relative that are not subject to payment by a third party unless the third party is a public program of a state or territory or political subdivision of a state or territory shall be deducted from countable income.

B. Medical and remedial care expenses paid by a public program (other than a Medicaid program) of a state or territory shall be deducted from countable income. Once countable income is reduced (by applying these deductions) to an amount equal to the MNIL, the individual or family shall be income eligible.

C. Reasonable measures to determine the legal liability of third parties to pay for incurred expenses shall be taken. However, eligibility determination shall not be forestalled simply because third party liability cannot be ascertained or payment by the third party has not been received.

D. The time standards for reaching decisions on Medicaid eligibility must be met when determining eligibility through spenddown: 90 days for applicants who apply on the basis of disability and 45 days for all other applicants. These limits shall apply for receipt of third party payment or verification of third party intent to pay in order to determine deductible expenses under spenddown. Efforts to determine the liability of a third party shall continue through the last day of this period. If information regarding third party liability is not received by this date, eligibility must be established based upon the information available.

E. If the amount subject to payment by a third party cannot be determined based on information available, the bill in question to which the third party liability applies cannot be used in determining the spenddown. However, if information becomes available at a later date, the spenddown shall be recalculated and the effective date of eligibility revised.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-10-8.2600 § 3, eff. April 30, 1995; amended, Virginia Register Volume 25, Issue 14, eff. April 15, 2009.

12VAC30-110-1050 Required deductions based on kinds of services

In determining incurred medical expenses to be deducted from income, the medical or remedial care expenses listed below that are not subject to payment by a third party shall be deducted from countable income. Such deductions are allowable even if the expenses are paid by a public program (other than the Medicaid program) of a state or territory if the program is financed by the state or territory.

1. Expenses for Medicare and other health insurance premiums, and deductible or coinsurance charges, including enrollment fees, copayments, or deductibles imposed by the State Plan for Medical Assistance.

2. Expenses incurred by the individual or family or financially responsible relative for necessary medical and remedial services that are recognized under state law but are not included in the State Plan for Medical Assistance.

3. Expenses incurred by the individual or family or by financially responsible relative for necessary medical and remedial services included in the State Plan for Medical Assistance including those that exceed agency limitations on amount, duration and scope of services.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-10-8.2600 § 4, eff. April 30, 1995.

12VAC30-110-1060 Required deductions based on the age of bills

In determining incurred medical expenses to be deducted from income, the agency must include the following:

1. For the retroactive budget period for medical assistance (the three months prior to the month of application), on expenses incurred during such period, whether paid or unpaid and "old bills" (unpaid expenses which remain a liability to the individual incurred prior to the period), to the extent that the expenses have not been deducted previously in establishing eligibility;

2. For the first prospective budget period, expenses incurred during such budget period and any of the three preceding months, whether paid or unpaid, to the extent that the expenses have not been deducted previously in establishing eligibility;

3. Current payments (that is, payments made in the current budget period) on expenses incurred before the current budget period and not previously deducted from income in any budget period in establishing eligibility for such period; and

4. If the individual's eligibility for medical assistance was established in each such budget period preceding the current budget period, expenses incurred before the current budget period but not previously deducted from income in establishing eligibility, to the extent that such expenses are unpaid and are:

a. Described in 12VAC30-110-1050; and

b. Carried over from the preceding budget period or periods because the individual had a spenddown liability in each such preceding period that was met without deducting all such incurred, unpaid expenses.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-10-8.2600 § 5, eff. April 30, 1995.

12VAC30-110-1070 Projection of expenses

Medical and remedial care expenses that are not for institutional care services (excluding acute care facility services) shall not be projected. For example, insurance premiums are not an institutional service, therefore, such expenses shall not be projected. Nor shall expenses that are included in a prepaid package of service be deducted prior to the date the services are rendered (e.g., charge for prenatal care and delivery services and orthodontia).

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-10-8.2600 § 6, eff. April 30, 1995.

12VAC30-110-1080 Projection of institutional care expenses

Institutional care expenses, except for expenses for services rendered in an acute care facility, shall be projected. The amount of the projected expenses shall be based on the Medicaid per diem rate or a combination of actual incurred institutional expenses and projected expenses at the Medicaid per diem rate. Projection of institutional care expenses does not preclude deduction of actually incurred expenses and in some instances requires the use of a combination of actually incurred expenses and projected expenses. Those circumstances are:

1. When the projected institutional care expense is less than the individual's spenddown liability for the budget period; and

2. When there is current liability for bills from a period prior to the current retroactive and prospective budget periods. A bill written off as a bad debt is not a current liability.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-10-8.2600 § 7, eff. April 30, 1995.

12VAC30-110-1090 [Reserved]. (Reserved)

12VAC30-110-1100 Individuals and families with income below the MNIL

Cases which have only regular income that is below the MNIL do not have to spenddown to become income eligible. Such cases shall be maintained in the same manner as categorically needy cases; however, effective the month that income exceeds the MNIL or the first month following the timely notification period, the case must be treated as all other spenddown cases. When a monthly budget period is used, increases in income shall be counted beginning the month the change occurs, unless a Medicaid card has already been issued for that month and a change in circumstances occurs too late in the month to provide "timely" notice under 42 CFR 435.919 prior to suspending Medicaid benefits.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-10-8.2600 § 9, eff. April 30, 1995.

12VAC30-110-1110 [Reserved]. (Reserved)

12VAC30-110-1120 Reconciliation

At the end of the first prospective budget period and any subsequent prospective budget period, or if earlier when any significant change occurs, the agency must reconcile any projected amounts with the actual amounts incurred, or with changes in circumstances to determine if the adjusted deduction of incurred expenses reduces countable income to the income standard.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-10-8.2600 § 11, eff. April 30, 1995.

12VAC30-110-1130 Eligibility

Except as provided in 12VAC30-110-1120, an individual is eligible on the first day of the month in which spenddown liability is met. However, expenses used to meet spenddown liability are not reimbursable under Medicaid. The amount paid by Medicaid will be reduced to the extent necessary to prevent the transfer of an individual's spenddown liability to the Medicaid program.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-10-8.2600 § 12, eff. April 30, 1995.

12VAC30-110-1140 Spenddown entitlement

A. When excess income has been spent or incurred, the applicant must request reinstatement of his application, submitting the "Record of Medical Expenses - Medicaid" together with bills or receipts for medical services either paid or incurred, and evidence of third party payment or denial of payment if applicable. No new application form is completed at that time. If there has been no change which renders him ineligible, he becomes eligible for the remainder of the six-month period.

B. The request for reinstatement must be processed in the same manner as an application, with notice to the client of the disposition of his request.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-10-8.2600 § 13, eff. April 30, 1995.

12VAC30-110-1150 Qualified Medicaid Beneficiaries

A. When an enrolled medically indigent Medicare beneficiary meets the medically needy spenddown, he continues to be eligible for Medicaid as a Qualified Medicare Beneficiary (QMB) but is also eligible for Medicaid as medically needy beginning the date the spenddown was met, and ending the last day of the six-month spenddown period.

B. No new application for QMB shall be required to continue entitlement as a QMB at the end of the budget period; however, the individual must file a new application in order for eligibility for full Medicaid benefits in subsequent budget periods.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-10-8.2600 § 14, eff. April 30, 1995.

12VAC30-110-1160 Retroactive spenddown; countable income; entitlement date

A. Eligibility for retroactive Medicaid entitlement must be determined in all cases in which an individual reports receiving a Medicaid-covered service during the three-month period prior to the month of application, whether the individual is applying for Aid to Families with Dependent Children, auxiliary grant or Medicaid. Eligibility for retroactive coverage shall be determined at the same time as the ongoing eligibility is determined, using the same application.

B. The amount of countable income available to the applicant's family or budget unit is determined for the three-month period prior to application if none of the three months was included in a prior Medicaid coverage or spenddown period, and all other eligibility factors were met. Countable income for the period shall be applied to the appropriate income limit for the period (¼ the annual income limit).

If any of the months in the retroactive period were included in a previous coverage or spenddown period, those months cannot be included in the retroactive period. Only the income received in the retroactive months not included in previous periods are counted in determining retroactive eligibility. Countable income is applied to the appropriate income limit for the number of months actually included in the retroactive period.

C. When the retroactive spenddown is met by medical expenses incurred before the retroactive period, eligibility will begin the first day of the retroactive period.

When the retroactive spenddown is met be expenses incurred during the retroactive period, eligibility will begin the date the spenddown was met.

Eligibility will exist for the remainder of the retroactive period.

When the spenddown is not met, retroactive eligibility does not exist.

If an applicant states that a covered service was received in any one of the three retroactive months, eligibility is to be determined for all three retroactive months, regardless of the service date.

D. The Medicaid application shall be processed to determine both retroactive and prospective Medicaid eligibility beginning with the month of application. Notice of both determinations must be provided in written form to the applicant.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-10-8.2600 § 15, eff. April 30, 1995.

12VAC30-110-1170 [Reserved]. (Reserved)

12VAC30-110-1200 Definitions

The following words and terms, when used in this part, shall have the following meanings unless the context indicates otherwise:

"Aid to Families with Dependent Children" or "AFDC" means the public assistance programs authorized in §§ 406 and 407 of the Social Security Act (42 USC §§ 606 and 607), and administered by the Virginia Department of Social Services. The term "AFDC" as used in this part includes Aid to Families with Dependent Children - Unemployed Parent (AFDC-UP).

"Assistance unit" means those persons who have been determined categorically and financially eligible to receive assistance as defined in the Virginia Department of Social Services' Virginia Independence Program regulations (22VAC40-35-5 et seq.).

"Caretaker-relative" means the natural or adoptive parent or other relative, as specified in 45 CFR 233.90(c)(1)(v), who is responsible for supervision and care of the needy child.

"Child" means an individual who would be considered a child under the AFDC State Plan.

"Family" means those individuals living in the household whose needs and income were included in determining the AFDC eligibility of the assistance unit at the time that the AFDC benefits were terminated and individuals under AFDC sanction whose income but not needs were included. It also includes those individuals whose needs and income would be taken into account in determining the AFDC eligibility of the caretaker-relative's assistance unit under the AFDC State Plan if the family were applying in the current month.

"Family income" means all the earned income, as defined in the AFDC State Plan, of all the members of the family without application of any disregards except the family's cost of child care necessary for the employment of the caretaker-relative or those disregards required by another federal statute.

"Transitional medical assistance" means extended medical assistance to participants in VIEW whose AFDC has been terminated voluntarily or involuntarily.

"Virginia Initiative for Employment not Welfare" or "VIEW" means the Job Opportunities and Basic Skills Training Program as implemented in the Commonwealth.

History

• Statutory Authority: §§ 32.1-325 and 63.1-133.46 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 15, eff. June 1, 1996.

12VAC30-110-1210 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 12, Issue 15, eff. June 1, 1996; repealed, Virginia Register Volume 19, Issue 18, eff. July 1, 2003.

12VAC30-110-1220 Scope of coverage

A. Subject to subsection B of this section, during the 12-month extension period, the amount, duration, and scope of medical assistance made available to a family shall be the same as if the family were still receiving AFDC.

B. The Department of Medical Assistance Services (DMAS), at its option may, pursuant to the requirements of the Health Insurance Premium Payment Program (HIPP) in Part XII (12VAC30-130-740 et seq.) of 12VAC30-130, pay a family's expenses for premiums, deductibles, coinsurance, and similar costs for health insurance or other health care coverage offered by an employer of the caretaker-relative or by an employer of the absent parent of a dependent child. If an employer offers such coverage to the caretaker-relative:

1. To receive transitional medical assistance coverage for himself and his family, the caretaker-relative shall make application for such employer coverage, but only if:

a. The employer does not require the caretaker-relative to make financial contributions for the coverage (whether through payroll deduction, payment of deductibles, coinsurance, or similar costs, or otherwise); and

b. DMAS provides, directly or otherwise, payment of any of the premium amount, deductible, coinsurance, or similar expense that the employee is otherwise required to pay; and

2. DMAS treats the coverage under the employer plan as a third party liability (as of May 1, 1995, under § 1902(a)(25) of the Social Security Act) (42 USC § 1396a(a)(25)).

C. DMAS shall consider payments for premiums, deductibles, coinsurance, and similar expenses as payments for medical assistance.

History

• Statutory Authority: §§ 32.1-325 and 63.1-133.46 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 15, eff. June 1, 1996.

12VAC30-110-1230 Written notice and reporting requirements

A. Notices. During the third, sixth and ninth months of any transitional assistance DMAS shall notify the family of the reporting requirements.

B. Reporting requirements. To receive continued transitional medical assistance, a family shall report the following to the local department of social services, not later than the 21st day of the fourth, seventh, and tenth month in the period of transitional assistance: the family's gross monthly earnings and the family's costs for child care necessary for the employment of the caretaker-relative in each month of the preceding three-month period. The local department of social services may permit continued transitional medical assistance, notwithstanding a failure to report, if the family has established good cause for the failure to report on a timely basis.

C. Good cause. The local department of social services may grant an extension regarding the reporting requirements for good cause shown, pursuant to the Medicaid Client Appeals regulations at Part I (12VAC30-110-10 et seq.) of this chapter.

D. Frequency of reporting. A family receiving transitional assistance shall not be required to report more frequently than as required under subsection B of this section.

E. Notice before termination. No termination of assistance shall become effective until the local department of social services provides the family with notice of the grounds for the termination. No termination shall be effective earlier than 10 days after the date of mailing of the notice.

History

• Statutory Authority: §§ 32.1-325 and 63.1-133.46 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 15, eff. June 1, 1996.

12VAC30-110-1240 Appeals

All appeals regarding the provision of services under this part shall be conducted pursuant to the Medicaid Client Appeals regulations at Part I (12VAC30-110-10 et seq.) of this chapter.

History

• Statutory Authority: §§ 32.1-325 and 63.1-133.46 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 15, eff. June 1, 1996.

12VAC30-110-1300 (Repealed.)

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 18, eff. July 1, 1997; repealed, Volume 27, Issue 9, eff. February 17, 2011; Errata, 27:10 VA.R. 964 January 17, 2011.

12VAC30-110-1350 Definitions

"Applicant" means a person who has directly or through his authorized representative made written application for Medicaid at the Department of Medical Assistance Services' Central Processing Unit or at the local social services department serving the locality in which he is a resident or, if institutionalized, the locality in which he last resided outside an institution.

"Authorized representative" means a person who is authorized to conduct the personal or financial affairs for an individual who is age 18 or older.

"Caretaker relative" means an individual who is age 18 or older, who is not a parent, but who is related to a child by blood or marriage and who lives with and assumes responsibility for day-to-day care of the child in a place of residence maintained as his or their own home.

"Competent individual" means a person who has not been judged by a court to be legally incapacitated.

"Conservator" means a person appointed by a court of competent jurisdiction to manage the estate and financial affairs of an incapacitated individual.

"Family substitute representative" means a spouse or designated relative who is willing and able to take responsibility for the individual's personal or financial affairs. The relatives who may be substitute representatives are, in this preferred order, the individual's adult child, parent, adult sibling, adult grandchild, adult niece or nephew, aunt or uncle.

"Guardian" means a person appointed by a court of competent jurisdiction to be responsible for the personal affairs of an incapacitated individual, including responsibility for making decisions regarding the person's support, care, health, safety, habilitation, education, therapeutic treatment, and, if not inconsistent with an order of commitment, residence.

"Incapacitated individual" means a person who, pursuant to an order of a court of competent jurisdiction, has been found to be incapable of receiving and evaluating information effectively or responding to people, events, or environments to such an extent that the individual lacks the capacity to (i) meet the essential requirements of his health, care, safety, or therapeutic needs without the assistance or protection of a guardian or (ii) manage property or financial affairs or provide for his support or for the support of his legal dependents without the assistance or protection of a conservator.

"Legal emancipation" means the minor has been declared emancipated by a court of competent jurisdiction. A married minor is not emancipated unless a court has declared the married minor emancipated from his parents.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 18, eff. June 19, 2003.

12VAC30-110-1360 Right to apply

A competent individual who is at least 18 years of age cannot be refused the right to complete an application for himself and cannot be discouraged from asking for assistance for himself under any circumstances.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia; 42 CFR 435.906 and 435.907.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 18, eff. June 19, 2003.

12VAC30-110-1370 Applicant's signature

The applicant must sign a state-approved official application form, even if another person fills out the form, unless the application is filed and signed by the applicant's parent, caretaker relative, legal guardian or conservator, attorney-in-fact or authorized representative. If the applicant cannot sign his name, but can make a mark, the mark must be correctly designated and witnessed by one person.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia; 42 CFR 435.906 and 435.907.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 18, eff. June 19, 2003.

12VAC30-110-1380 Authorized representative for individual 18 years of age or older

A. Patients in the Department of Behavioral Health and Developmental Services (DBHDS) facilities may have applications submitted on their behalf by employees of the DBHDS.

B. The authorized representative of an incapacitated individual shall be the individual's legally appointed guardian or conservator.

C. A competent individual may sign an application on the individual's own behalf or may designate anyone to be his authorized representative to file a Medicaid application on the individual's behalf. If a competent individual wants another person to file a Medicaid application for him, the individual must designate the authorized representative in a written statement that is signed by the individual applicant. The authorized representative statement is valid for the life of the Medicaid application or until the applicant changes or removes the applicant's authorized representative. If the application is approved, the authorized representative statement is valid for any subsequent review and redetermination until the applicant's Medicaid eligibility is cancelled. If the applicant reapplies for Medicaid after Medicaid is canceled, the applicant must sign the application or provide a new authorized representative statement.

D. When an individual has given power-of-attorney to another person that includes the power to conduct the applicant's business affairs, the attorney-in-fact is considered the applicant's authorized representative.

E. For an individual who has not been determined by a court to be legally incapacitated, but who is reported to be mentally unable to sign his name or to make a mark, an application may be signed under the following circumstances:

1. When it is reported that an individual cannot sign the application and the individual does not have an attorney-in-fact, an authorized representative or a family substitute representative, the individual's inability to sign the application must be verified by a written statement from the individual's physician that the individual is mentally unable to sign and file a Medicaid application because of the individual's diagnosis or condition.

2. If the individual does not have an attorney-in-fact and has not signed a statement authorizing another person or organization to apply for Medicaid on the individual's behalf, the applicant's spouse will be considered to be the individual's authorized representative. If the individual is not married or is estranged from the individual's spouse or his spouse is unable to represent the individual, the individual's authorized representative shall be a family substitute representative.

3. Treatment of an individual who is unable to sign and who has no authorized representative or family substitute representative:

a. When motion to appoint a guardian or conservator has been filed with the court, but a final determination has not been ordered. When an individual's physician has verified that the physician is unable to sign the Medicaid application and the individual has no legal representative, a determination of Medicaid eligibility shall not be completed until a guardian or conservator has been appointed. Any application filed on behalf of such individual shall be held in pending status until the appointment of a legal guardian or conservator. The eligibility worker shall mail the legal guardian or conservator a copy of the Medicaid application. The legal guardian or conservator shall have 10 working days after appointment to sign and return the Medicaid application and documentation of the guardian or conservator's appointment. If the application has not been signed by the deadline, eligibility for Medicaid shall be denied.

b. When motion to appoint a guardian or conservator has not been filed with the court. When a motion to appoint a guardian or conservator has not been filed with the court, the eligibility worker shall refer the individual to the Adult Protective Services unit in the local department of social services. The Medicaid application shall be held in pending status until the adult protective services investigation is complete. If the completed adult protective services investigation concludes that guardianship proceedings will not be initiated, the application must be signed by the applicant or the applicant must sign a statement designating an authorized representative. If after 10 working days the application is not signed, eligibility for Medicaid shall be denied.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia; 42 CFR 435.906 and 435.907.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 18, eff. June 19, 2003; amended, Virginia Register Volume 42, Issue 11, eff. February 11, 2026.

12VAC30-110-1390 Authorized representative for children younger than 18 years of age

A. Patients younger than 18 years of age in facilities operated by the DBHDS may have applications submitted by employees of DBHDS.

B. A minor child younger than 18 years of age who is a parent may apply for Medicaid for his own child.

C. An authorized employee of the public or private child-placing agency that has custody of the child must sign the Medicaid application for a child younger 18 years of age that is in foster care.

D. A child applicant who is younger 18 years of age is not legally able to sign a Medicaid application for himself unless the child applicant is legally emancipated from the child applicant's parents. If the child applicant is not legally emancipated, his parents shall sign the application on the child applicant's behalf. If the child applicant is married and the child applicant's spouse is 18 years of age or older, the spouse may sign the application on the child applicant's behalf. If the child applicant does not live with a parent or spouse who is 18 years of age or older, the adult who has legal custody or who is the legal guardian of the child applicant, or the caretaker relative with whom the child applicant lives must sign the application. A child applicant's parent, guardian, legal custodian, or caretaker relative may designate an authorized representative to complete a Medicaid application on behalf of the child applicant. The authorization must be in writing in accordance with 12VAC30-110-1380.

E. If the child applicant has no adult guardian, adult caretaker relative, or legal custodian, then the caregiver for the child applicant is responsible for seeking custody or guardianship of the child applicant:

1. If a motion has been filed in court to appoint a guardian or seek legal custody of the child, the Medicaid application shall be held in a pending status. If verification is received within 10 working days that court action has been initiated, the application will be continued until the guardian is appointed or custody is awarded. When the guardian has been appointed or custody awarded, the eligibility worker must provide the Medicaid application to the guardian or custodian. The guardian or custodian must return the signed application and documentation of his appointment within 10 working days. If the application or documentation is not returned by either 10-day deadline, Medicaid eligibility shall be denied.

2. If guardianship or custody procedures have not been filed with the court, the eligibility worker must refer the child to the appropriate child welfare service worker. The application for Medicaid shall be held in a pending status until the service investigation is completed and any court proceedings are completed. If the court emancipates the child, the child must sign the application and return it to the eligibility worker within 10 working days. If a guardian is appointed or custody awarded, the eligibility worker must provide the Medicaid application to the guardian or custodian. The guardian or custodian must return the signed application and documentation of his appointment within 10 working days. If the application or documentation is not returned by the deadline, Medicaid eligibility shall be denied.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia; 42 CFR 435.906 and 435.907.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 18, eff. June 19, 2003; amended, Virginia Register Volume 42, Issue 11, eff. February 11, 2026.

12VAC30-110-1400 Authorized representative for a deceased applicant

An application may be made on behalf of a deceased person by his guardian or conservator, attorney-in-fact, executor or administrator of his estate, his surviving spouse, or his surviving family member, in this order of preference: adult child, parent, adult sibling, adult niece or nephew, or aunt or uncle. Such application must be filed within the three-month period subsequent to the month in which the death occurred if the deceased applicant received a Medicaid-covered service on or before the date of death and the date of service occurred within a month covered by the Medicaid application.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia; 42 CFR 435.906 and 435.907.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 18, eff. June 19, 2003.

12VAC30-110-1410 Persons prohibited from signing an application

An employee of, or an entity hired by, a medical service provider who could obtain Medicaid payments shall not sign a Medicaid application for a deceased individual or on behalf of an individual who cannot designate an authorized representative.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia; 42 CFR 435.906 and 435.907.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 18, eff. June 19, 2003.

12VAC30-110-1500 Working individuals with disabilities; basic coverage group (Ticket to Work and Work Incentive Improvement Act (TWWIIA))

A. Definitions.

"Eligible person" means someone who is (i) disabled: an applicant is deemed to be disabled for the purposes of program eligibility if he is enrolled in the Supplemental Security Income (SSI) or Social Security Disability Insurance (SSDI) programs. If the applicant has not had a disability determination through the Social Security Administration, he must have such a determination through the Disability Determination Services program; (ii) employed or can show proof of imminent prospective employment; (iii) between the ages of 16 years and 64 years; (iv) not subject to spending down of excess resources; (v) not an inpatient in an institution of mental disease (IMD), nor an inmate in a public institution that is not medical facility pursuant to the Act § 1902(a)(10)(A)(ii)(XV).

B. Scope/purpose. The purpose of this program shall be to afford persons who are disabled with the opportunity to be employed and retain more of their earned income without risking the loss of their Medicaid coverage of critical health care benefits.

C. In conformance with 12VAC30-30-20, 12VAC30-40-280, 12VAC30-40-290, and 12VAC30-40-105, eligible persons must meet the definition in subsection A of this section to be approved for this program.

D. In conformance with 12VAC30-40-105, working individuals with disabilities must meet these requirements for continuing eligibility pursuant to the Act § 1902(a)(10)(A)(ii)(XV):

1. Continue to meet the disability, age, and employment criteria described in this section. Individuals who, as enrollees, are unable to maintain employment due to illness or unavoidable job loss may remain in the program as unemployed for up to six months;

2. Have enrollee-countable earned income of no more than 200% FPL;

a. The standard SSI methodology shall be used to determine "countable" income;

b. The enrollee shall be treated as a "household of one" and spousal income shall be disregarded for ongoing enrollee eligibility; and

3. Have resources or assets up to the annual SSI "threshold amount" (Social Security Act, § 1619(b)) as established for Virginia by the Social Security Administration (SSA), if such resources or assets are accumulated solely from enrollee earnings after the individual is enrolled with Medicaid Buy-In under § 1902(a)(10)(A)(ii)(XV).

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. July 23, 2009.

12VAC30-110-1600 12VAC30-110-1600. (Reserved).. (Reserved)

History

• Statutory Authority: § 32.1-351 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 27, Issue 7, eff. January 5, 2011.

12VAC30-110-1610 Deemed newborn eligibility under FAMIS.

A child born to a woman who is eligible for and receiving Title XXI coverage through the Family Access to Medical Insurance Security Plan (FAMIS) or related waivers, such as FAMIS MOMS, as of the date of the child's birth and who is screened to be income eligible for coverage under Medicaid is deemed Medicaid/FAMIS eligible for one year from his date of birth.

History

• Statutory Authority: § 32.1-351 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 27, Issue 7, eff. January 5, 2011.

12VAC30-110-1620 Coverage of former foster care youth

A. The Title IV-A agency or the Department of Medical Assistance Services Central Processing Unit determines eligibility for Title XIX services.

B. Former foster care children younger than the age of 26 years who are not otherwise mandatorily eligible in another Medicaid classification and who were on Medicaid and in foster care when they turned age 18 years or aged out of foster care are eligible for medical assistance as specified. Individuals qualifying under this eligibility group shall meet the following criteria:

1. They shall be younger than the age of 26 years;

2. They shall not be otherwise eligible for or enrolled in mandatory coverage under the state plan; and

3. They were in foster care in a state other than Virginia and were enrolled in Medicaid under the state plan of that state when they turned age 18 years or at the time of aging out of the foster care program.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 34, Issue 19, eff. June 15, 2018.

Chapter 120 Waivered Services

Part I Program of All-Inclusive Care for the Elderly (PACE) (Repealed)

12VAC30-120-61 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 16, Issue 18, eff. July 1, 2000; amended, Virginia Register Volume 23, Issue 16, eff. July 1, 2007; repealed, Virginia Register Volume 25, Issue 8, eff. February 5, 2009.

12VAC30-120-62 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 16, Issue 18, eff. July 1, 2000; amended, Virginia Register Volume 23, Issue 16, eff. July 1, 2007; repealed, Virginia Register Volume 25, Issue 8, eff. February 5, 2009.

12VAC30-120-63 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 16, Issue 18, eff. July 1, 2000; repealed, Virginia Register Volume 25, Issue 8, eff. February 5, 2009.

12VAC30-120-64 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 16, Issue 18, eff. July 1, 2000; amended, Virginia Register Volume 23, Issue 16, eff. July 1, 2007; repealed, Virginia Register Volume 25, Issue 8, eff. February 5, 2009.

12VAC30-120-65 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 16, Issue 18, eff. July 1, 2000; amended, Virginia Register Volume 23, Issue 16, eff. July 1, 2007; repealed, Virginia Register Volume 25, Issue 8, eff. February 5, 2009.

12VAC30-120-66 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 16, Issue 18, eff. July 1, 2000; amended, Virginia Register Volume 23, Issue 16, eff. July 1, 2007; repealed, Virginia Register Volume 25, Issue 8, eff. February 5, 2009.

12VAC30-120-67 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 16, Issue 18, eff. July 1, 2000; repealed, Virginia Register Volume 25, Issue 8, eff. February 5, 2009.

12VAC30-120-68 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 16, Issue 18, eff. July 1, 2000; amended, Virginia Register Volume 23, Issue 16, eff. July 1, 2007; repealed, Virginia Register Volume 25, Issue 8, eff. February 5, 2009.

Part II Home and Community-Based Services for Technology Assisted Individual (Repealed)

12VAC30-120-70 (Repealed.)

Home and Community-Based Services for Technology Assisted Individual (Repealed)

History

• Historical Notes: Derived from VR460-04-8.5 § 1, eff. June 22, 1991; amended, Virginia Register Volume 13, Issue 22, eff. August 20, 1997; Volume 25, Issue 20, eff. July 9, 2009; repealed, Virginia Register Volume 30, Issue 12, eff. March 13, 2014.

12VAC30-120-80 (Repealed.)

Historical Notes

Derived from VR460-04-8.5 § 2, eff. June 22, 1991; amended, Virginia Register Volume 13, Issue 22, eff. August 20, 1997; repealed, Virginia Register Volume 30, Issue 12, eff. March 13, 2014.

12VAC30-120-90 (Repealed.)

History

• Historical Notes: Derived from VR460-04-8.5 § 3, eff. June 22, 1991; amended, Virginia Register Volume 13, Issue 22, eff. August 20, 1997; Volume 25, Issue 20, eff. July 9, 2009; repealed, Virginia Register Volume 30, Issue 12, eff. March 13, 2014.

12VAC30-120-100 (Repealed.)

History

• Historical Notes: Derived from VR460-04-8.5 § 4, eff. June 22, 1991; amended, Virginia Register Volume 13, Issue 22, eff. August 20, 1997; Volume 24, Issue 26, eff. October 15, 2008; repealed, Virginia Register Volume 30, Issue 12, eff. March 13, 2014.

12VAC30-120-110 (Repealed.)

History

• Historical Notes: Derived from VR460-04-8.5 § 5, eff. June 22, 1991; amended, Virginia Register Volume 13, Issue 22, eff. August 20, 1997; repealed, Virginia Register Volume 30, Issue 12, eff. March 13, 2014.

12VAC30-120-115 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 13, Issue 22, eff. August 20, 1997; repealed, Virginia Register Volume 30, Issue 12, eff. March 13, 2014.

12VAC30-120-120 (Repealed.)

History

• Historical Notes: Derived from VR460-04-8.5 § 6, eff. June 22, 1991; amended, Virginia Register Volume 13, Issue 22, eff. August 20, 1997; repealed, Virginia Register Volume 30, Issue 12, eff. March 13, 2014.

12VAC30-120-130 (Repealed.)

Historical Notes

Derived from VR460-04-8.5 § 7, eff. June 22, 1991; repealed, Virginia Register Volume 13, Issue 22, eff. August 20, 1997.

Part III Home and Community-Based Services for Individuals with Acquired Immunodeficiency Syndrome (AIDS) and AIDS-Related Complex (Repealed)

12VAC30-120-140 (Repealed.)

Historical Notes

Derived from VR460-04-8.11 § 1, eff. February 1, 1991; amended, Virginia Register Volume 20, Issue 11, eff. March 11, 2004; Volume 25, Issue 14, eff. April 15, 2009; Errata, 25:16 VA.R. 2978 April 13, 2009; amended, Virginia Register Volume 25, Issue 20, eff. July 9, 2009; Errata, 25:23 VA.R. 4262 July 20, 2009; repealed, Virginia Register Volume 29, Issue 18, eff. June 20, 2013.

12VAC30-120-150 (Repealed.)

History

• Historical Notes: Derived from VR460-04-8.11 § 2, eff. February 1, 1991; amended, Virginia Register Volume 20, Issue 11, eff. March 11, 2004; repealed, Virginia Register Volume 29, Issue 18, eff. June 20, 2013.

12VAC30-120-160 (Repealed.)

History

• Historical Notes: Derived from VR460-04-8.11 § 3, eff. February 1, 1991; amended, Virginia Register Volume 20, Issue 11, eff. March 11, 2004; Volume 27, Issue 3, eff. November 10, 2010; repealed, Virginia Register Volume 29, Issue 18, eff. June 20, 2013.

12VAC30-120-165 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 20, Issue 11, eff. March 11, 2004; amended, Virginia Register Volume 27, Issue 19, eff. July 1, 2011; repealed, Virginia Register Volume 29, Issue 18, eff. June 20, 2013; Errata, 30:2 VA.R. 274 September 23, 2013.

12VAC30-120-170 (Repealed.)

History

• Historical Notes: Derived from VR460-04-8.11 § 4, eff. February 1, 1991; amended, Virginia Register Volume 20, Issue 11, eff. March 11, 2004; repealed, Virginia Register Volume 29, Issue 18, eff. June 20, 2013.

12VAC30-120-180 (Repealed.)

History

• Historical Notes: Derived from VR460-04-8.11 § 5, eff. February 1, 1991; amended, Virginia Register Volume 20, Issue 11, eff. March 11, 2004; amended, Volume 27, Issue 19, eff. July 1, 2011; repealed, Virginia Register Volume 29, Issue 18, eff. June 20, 2013.

12VAC30-120-190 (Repealed.)

History

• Historical Notes: Derived from VR460-04-8.11 § 6, eff. February 1, 1991; amended, Virginia Register Volume 20, Issue 11, eff. March 11, 2004; amended, Volume 27, Issue 19, eff. July 1, 2011; repealed, Volume 29, Issue 18, eff. June 20, 2013.

12VAC30-120-195 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 20, Issue 11, eff. March 11, 2004; amended, Virginia Register Volume 26, Issue 4, eff. January 1, 2010; repealed, Virginia Register Volume 29, Issue 18, eff. June 20, 2013.

12VAC30-120-200 (Repealed.)

Historical Notes

Derived from VR460-04-8.11 § 7, eff. February 1, 1991; repealed, Virginia Register Volume 20, Issue 11, eff. March 11, 2004.

12VAC30-120-201 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 20, Issue 11, eff. March 11, 2004; repealed, Virginia Register Volume 29, Issue 18, eff. June 20, 2013.

12VAC30-120-210 (Repealed.)

Historical Notes

Derived from VR460-04-8.12 § 1, eff. January 1, 1992; amended, Virginia Register Volume 10, Issue 13, eff. April 20, 1994; Virginia Register Volume 14, Issue 7, eff. January 22, 1998; Errata, 14:11 VA.R. 1869 February 16, 1998; repealed, Virginia Register Volume 18, Issue 26, eff. October 16, 2002.

Part IV Mental Retardation Waiver (Repealed)

12VAC30-120-211 (Repealed.)

Mental Retardation Waiver (Repealed)

Historical Notes

Derived from Virginia Register Volume 18, Issue 26, eff. October 16, 2002; amended, Virginia Register Volume 22, Issue 19, eff. June 28, 2006; Volume 25, Issue 20, eff. July 9, 2009; repealed, Virginia Register Volume 29, Issue 20, eff. July 4, 2013.

12VAC30-120-213 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 26, eff. October 16, 2002; amended, Virginia Register Volume 22, Issue 19, eff. June 28, 2006; Volume 25, Issue 20, eff. July 9, 2009; repealed, Virginia Register Volume 29, Issue 20, eff. July 4, 2013.

12VAC30-120-215 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 26, eff. October 16, 2002; amended, Virginia Register Volume 22, Issue 19, eff. June 28, 2006; Volume 22, Issue 24, eff. September 6, 2006; repealed, Virginia Register Volume 29, Issue 20, eff. July 4, 2013.

12VAC30-120-217 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 26, eff. October 16, 2002; amended, Virginia Register Volume 22, Issue 19, eff. June 28, 2006; repealed, Virginia Register Volume 29, Issue 20, eff. July 4, 2013.

12VAC30-120-219 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 26, eff. October 16, 2002; amended, Virginia Register Volume 22, Issue 19, eff. June 28, 2006; repealed, Virginia Register Volume 29, Issue 20, eff. July 4, 2013.

12VAC30-120-220 (Repealed.)

Historical Notes

Derived from VR460-04-8.12 § 2, eff. January 1, 1992; amended, Virginia Register Volume 10, Issue 13, eff. April 20, 1994; Virginia Register Volume 14, Issue 7, eff. January 22, 1998; repealed, Virginia Register Volume 18, Issue 26 eff. October 16, 2002.

12VAC30-120-221 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 26, eff. October 16, 2002; amended, Virginia Register Volume 22, Issue 19, eff. June 28, 2006; repealed, Virginia Register Volume 29, Issue 20, eff. July 4, 2013.

12VAC30-120-223 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 26, eff. October 16, 2002; amended, Virginia Register Volume 22, Issue 19, eff. June 28, 2006; repealed, Virginia Register Volume 29, Issue 20, eff. July 4, 2013.

12VAC30-120-225 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 26, eff. October 16, 2002; amended, Virginia Register Volume 22, Issue 19, eff. June 28, 2006; Volume 25, Issue 20, eff. July 9, 2009; repealed, Virginia Register Volume 29, Issue 20, eff. July 4, 2013.

12VAC30-120-227 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 26, eff. October 16, 2002; amended, Virginia Register Volume 22, Issue 19, eff. June 28, 2006; repealed, Virginia Register Volume 29, Issue 20, eff. July 4, 2013.

12VAC30-120-229 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 26, eff. October 16, 2002; amended, Virginia Register Volume 22, Issue 19, eff. June 28, 2006; Volume 25, Issue 20, eff. July 9, 2009; repealed, Virginia Register Volume 29, Issue 20, eff. July 4, 2013.

12VAC30-120-230 (Repealed.)

Historical Notes

Derived from VR460-04-8.12 § 3, eff. January 1, 1992; amended, Virginia Register Volume 10, Issue 13, eff. April 20, 1994; Virginia Register Volume 14, Issue 7, eff. January 22, 1998; Errata, 14:11 VA.R. 1869, 1870 February 16, 1998; repealed, Virginia Register Volume 18, Issue 26, eff. October 16, 2002.

12VAC30-120-231 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 26, eff. October 16, 2002; amended, Virginia Register Volume 22, Issue 19, eff. June 28, 2006; repealed, Virginia Register Volume 29, Issue 20, eff. July 4, 2013.

12VAC30-120-233 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 26, eff. October 16, 2002; amended, Virginia Register Volume 22, Issue 19, eff. June 28, 2006; repealed, Virginia Register Volume 29, Issue 20, eff. July 4, 2013.

12VAC30-120-235 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 26, eff. October 16, 2002; repealed, Virginia Register Volume 29, Issue 20, eff. July 4, 2013.

12VAC30-120-237 (Repealed.)

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 26, eff. October 16, 2002; amended, Virginia Register Volume 22, Issue 19, eff. June 28, 2006; Volume 25, Issue 20, eff. July 9, 2009; repealed, Virginia Register Volume 29, Issue 20, eff. July 4, 2013.

12VAC30-120-240 (Repealed.)

Historical Notes

Derived from VR460-04-8.12 § 4, eff. January 1, 1992; amended, Virginia Register Volume 10, Issue 13, eff. April 20, 1994; Virginia Register Volume 14, Issue 7, eff. January 22, 1998; Errata, 14:11 VA. R. 1870 February 16, 1998; repealed, Virginia Register Volume 18, Issue 26, eff. October 16, 2002.

12VAC30-120-241 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 26, eff. October 16, 2002; amended, Virginia Register Volume 22, Issue 19, eff. June 28, 2006; repealed, Virginia Register Volume 29, Issue 20, eff. July 4, 2013.

12VAC30-120-243 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 18, Issue 26, eff. October 16, 2002; repealed, Virginia Register Volume 22, Issue 19, eff. June 28, 2006.

12VAC30-120-245 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 26, eff. October 16, 2002; amended, Virginia Register Volume 22, Issue 19, eff. June 28, 2006; repealed, Virginia Register Volume 29, Issue 20, eff. July 4, 2013.

12VAC30-120-247 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 26, eff. October 16, 2002; amended, Virginia Register Volume 22, Issue 19, eff. June 28, 2006; Volume 25, Issue 20, eff. July 9, 2009; repealed, Virginia Register Volume 29, Issue 20, eff. July 4, 2013.

12VAC30-120-249 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 26, eff. October 16, 2002; Errata, 19:3 VA.R. 549 October 2, 2002; amended, Virginia Register Volume 22, Issue 19, eff. June 28, 2006; repealed, Virginia Register Volume 29, Issue 20, eff. July 4, 2013.

12VAC30-120-250 (Repealed.)

Historical Notes

Derived from VR460-04-8.12 § 5, eff. January 1, 1992; amended, Virginia Register Volume 10, Issue 13, eff. April 20, 1994; Virginia Register Volume 14, Issue 7, eff. January 22, 1998; Errata, 14:11 VA.R. 1870 Febraury 16, 1998; repealed, Virginia Register Volume 18, Issue 26, eff. October 16, 2002.

Part V Medallion (Repealed)

12VAC30-120-260 (Repealed.)

History

• Historical Notes: Derived from VR460-04-8.14 § 1, eff. July 1, 1993; amended, Virginia Register Volume 12, Issue 16, eff. June 1, 1996; Volume 19, Issue 23, eff. August 27, 2003; Volume 21, Issue 11, eff. March 10, 2005; repealed, Virginia Register Volume 30, Issue 12, eff. March 28, 2014.

12VAC30-120-270 (Repealed.)

History

• Historical Notes: Derived from VR460-04-8.14 § 2, eff. July 1, 1993; amended, Virginia Register Volume 12, Issue 16, eff. June 1, 1996; repealed, Virginia Register Volume 30, Issue 12, eff. March 28, 2014.

12VAC30-120-280 (Repealed.)

History

• Historical Notes: Derived from VR460-04-8.14 § 3, eff. July 1, 1993; amended, Virginia Register Volume 12, Issue 16, eff. June 1, 1996; Volume 19, Issue 23, eff. August 27, 2003; Volume 21, Issue 11, eff. March 10, 2005; Volume 22, Issue 8, eff. April 3, 2006; Volume 22, Issue 26, eff. November 20, 2006; repealed, Virginia Register Volume 30, Issue 12, eff. March 28, 2014.

12VAC30-120-290 (Repealed.)

History

• Historical Notes: Derived from VR460-04-8.14 § 4, eff. July 1, 1993; amended, Virginia Register Volume 12, Issue 16, eff. June 1, 1996; Volume 21, Issue 11, eff. March 10, 2005; Volume 22, Issue 26, eff. November 20, 2006; repealed, Virginia Register Volume 30, Issue 12, eff. March 28, 2014.

12VAC30-120-300 (Repealed.)

History

• Historical Notes: Derived from VR460-04-8.14 § 5, eff. July 1, 1993; amended, Virginia Register Volume 12, Issue 16, eff. June 1, 1996; Volume 19, Issue 23, eff. August 27, 2003; repealed, Virginia Register Volume 30, Issue 12, eff. March 28, 2014.

12VAC30-120-310 (Repealed.)

History

• Historical Notes: Derived from VR460-04-8.14 § 6, eff. July 1, 1993; amended, Virginia Register Volume 12, Issue 16, eff. June 1, 1996; Volume 21, Issue 11, eff. March 10, 2005; Volume 22, Issue 26, eff. November 20, 2006; Volume 26, Issue 8, eff. January 21, 2010; repealed, Virginia Register Volume 30, Issue 12, eff. March 28, 2014.

12VAC30-120-320 (Repealed.)

History

• Historical Notes: Derived from VR460-04-8.14 § 7, eff. July 1, 1993; amended, Virginia Register Volume 12, Issue 16, eff. June 1, 1996; Volume 21, Issue 11, eff. March 10, 2005; Volume 22, Issue 26, eff. November 20, 2006; repealed, Virginia Register Volume 30, Issue 12, eff. March 28, 2014.

12VAC30-120-330 (Repealed.)

History

• Historical Notes: Derived from VR460-04-8.14 § 8, eff. July 1, 1993; amended, Virginia Register Volume 12, Issue 16, eff. June 1, 1996; repealed, Virginia Register Volume 30, Issue 12, eff. March 28, 2014.

12VAC30-120-340 (Repealed.)

History

• Historical Notes: Derived from VR460-04-8.14 § 9, eff. July 1, 1993; amended, Virginia Register Volume 12, Issue 16, eff. June 1, 1996; repealed, Virginia Register Volume 30, Issue 12, eff. March 28, 2014.

12VAC30-120-350 (Repealed.)

History

• Historical Notes: Derived from VR460-04-8.14 § 10, eff. July 1, 1993; amended, Virginia Register Volume 12, Issue 16, eff. June 1, 1996; Volume 21, Issue 11, eff. March 10, 2005; repealed, Virginia Register Volume 30, Issue 12, eff. March 28, 2014.

Part VI Medallion Mandatory Managed Care

12VAC30-120-360 Definitions

The following words and terms when used in this part shall have the following meanings unless the context clearly indicates otherwise. All other words and terms used in this part shall comply with the definitions in the contract and those identified 42 CFR 438.2:

"Adverse benefit determination" means, consistent with 42 CFR 438.400, (i) the denial or limited authorization of a requested service; (ii) the failure to take action or timely take action on a request for service; (iii) the reduction, suspension, or termination of a previously authorized service; (iv) the denial in whole or in part of a payment for a covered service; (v) the failure to provide services within the timeframes required by the state, or for a resident of a rural exception area with only one MCO, the denial of a member's request to exercise his right under 42 CFR 438.52(b)(2)(ii) to obtain services outside of the network; (vi) the denial of a member's request to dispute a financial liability; or (vii) the failure of an MCO to act within the timeframes provided in 42 CFR 438.408(b).

"Appeal" when applicable to a member means a request to DMAS to review an MCO's internal appeal decision to uphold the contractor's adverse benefit determination. For members, an appeal may only be requested after exhaustion of the MCO's one step internal appeal process. Member appeals to DMAS will be conducted in accordance with regulations at 42 CFR 431 Subpart E and 12VAC30-110-10 through 12VAC30-110-370.

"Appeal" when applicable to an appeal by a provider means a request to DMAS to review an MCO's reconsideration decision. For providers, an appeal may only be requested after exhaustion of the MCO's reconsideration process. Provider appeals to DMAS will be conducted in accordance with the requirements set forth in § 2.2-4000 et seq. of the Code of Virginia and 12VAC30-20-500 et seq.

"Covered services" means Medicaid services as defined in the State Plan for Medical Assistance.

"Day" means calendar day unless otherwise stated.

"Disenrollment" means the process of changing enrollment from one managed care organization (MCO) plan to another MCO, if applicable.

"DMAS" means the Department of Medical Assistance Services.

"Eligible person" means any person eligible for Virginia Medicaid in accordance with the State Plan for Medical Assistance under Title XIX of the Social Security Act.

"Emergency services" means those health care services that are rendered by participating or nonparticipating providers after the sudden onset of a medical condition manifesting itself by acute symptoms of sufficient severity, including severe pain, that a prudent layperson who possesses an average knowledge of health and medicine could reasonably expect the absence of immediate medical attention to result in (i) placing the client's health in serious jeopardy; (ii) with respect to a pregnant woman, placing the health of the woman or her unborn child in serious jeopardy; (iii) serious impairment to bodily functions; or (iv) serious dysfunction of any bodily organ or part.

"Exclude" means the removal of a member from the Medallion mandatory managed care program on a temporary or permanent basis.

"External quality review organization" or "EQRO" means an organization that meets the competence and independence requirements set forth in 42 CFR 438.354 and performs external quality reviews, other external quality review related activities as set forth in 42 CFR 438.358, or both.

"Grievance" means, in accordance with 42 CFR 438.400, an expression of dissatisfaction about any matter other than an "adverse benefit determination." Possible subjects for grievances include the quality of care or services provided; aspects of interpersonal relationships, such as rudeness of a provider or employee; or failure to respect the member's rights.

"Health care professional" means a provider as defined in 42 CFR 438.2.

"Individual" means a person who is eligible for Medicaid who is not yet undergoing enrollment for mandatory managed care and who is not enrolled in a mandatory managed care organization.

"Internal appeal" means a request to the MCO by a member or by a member's authorized representative or provider acting on behalf of the member and with the member's written consent for review of a contractor's adverse benefit determination, as defined in 42 CFR 438.400. The internal appeal is the only level of appeal with the MCO and must be exhausted by a member or deemed exhausted according to 42 CFR 438.408(c)(3) before the member may initiate a state fair hearing with DMAS.

"Managed care organization" or "MCO" means an organization that offers managed care health insurance plans (MCHIP), as defined by § 38.2-5800 of the Code of Virginia. Any health maintenance organization as defined in § 38.2-4300 of the Code of Virginia or health carrier that offers preferred provider contracts or policies as defined in § 38.2-3407 of the Code of Virginia or preferred provider subscription contracts as defined in § 38.2-4209 of the Code of Virginia shall be deemed to be offering one or more MCHIPs. For the purposes of this definition, the prohibition of balance billing by a provider shall not be deemed a benefit payment differential incentive for covered persons to use providers who are directly or indirectly managed by, owned by, under contract with, or employed by the health carrier. A single managed care health insurance plan may encompass multiple products and multiple types of benefit payment differentials; however, a single managed care health insurance plan shall encompass only one provider network or set of provider networks.

Additionally, and in accordance with 42 CFR 438.2, "managed care organization" or "MCO" means an entity that has qualified to provide the services covered in the Medallion program to qualifying Medallion members as accessible in terms of timeliness, amount, duration, and scope as those services are to other Medicaid members within the area served, and that meets the solvency standards of 42 CFR 438.116.

"Mandatory managed care program" means the same as set forth in 42 CFR 438.54(b) and (d).

"Member" means a person eligible for Medicaid or Family Access to Medical Insurance Security who has been assigned to a Medicaid MCO.

"Network provider" means doctors, hospitals, or other health care providers who participate or contract with an MCO contractor and as a result agree to accept a mutually agreed upon sum or fee schedule as payment in full for covered services that are rendered to eligible participants.

"Newborn enrollment period" means the period from the child's date of birth plus the next two calendar months.

"PCP of record" means a primary care physician of record with whom the recipient has an established history, and such history is documented in the individual's records.

"Reconsideration" means a provider's request to the MCO for review of an adverse benefit determination. The MCO's reconsideration decision is a prerequisite to a provider's filing of an appeal, as provided for in 12VAC30-20-500 through 12VAC30-20-560, to DMAS Appeals Division.

"Rural exception" means a rural area designated in the § 1915(b) managed care waiver, pursuant to § 1932(a)(3)(B) of the Social Security Act and 42 CFR 438.52(b) and recognized by the Centers for Medicare and Medicaid Services, wherein qualifying mandatory managed care members are mandated to enroll in the one available contracted MCO.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 5, eff. January 1, 1997; amended, Virginia Register Volume 14, Issue 6, eff. January 7, 1998; Volume 14, Issue 18, eff. July 1, 1998; Volume 15, Issue 18, eff. July 1, 1999; Volume 19, Issue 3, eff. December 1, 2002; Volume 19, Issue 23, eff. August 27, 2003; Volume 21, Issue 11, eff. March 10, 2005; Volume 29, Issue 2, eff. October 25, 2012; Volume 30, Issue 6, eff. January 2, 2014; Volume 30, Issue 7, eff. January 2, 2014; Volume 30, Issue 12, eff. March 28, 2014; Volume 32, Issue 22, eff. July 27, 2016; Volume 35, Issue 14, eff. April 18, 2019.

12VAC30-120-370 Medallion mandatory managed care members

A. DMAS shall determine enrollment in Medallion mandatory managed care.

1. Medicaid eligible persons not meeting the exclusion criteria set out in subsection B of this section shall participate in the Medallion mandatory managed care program. Enrollment in Medallion mandatory managed care shall not be a guarantee of continuing eligibility for services and benefits under the Virginia Medical Assistance Services Program.

2. DMAS reserves the right to exclude from participation in the Medallion mandatory managed care program any member who has been consistently noncompliant with the policies and procedures of managed care or who is threatening to providers, MCOs, or DMAS. There must be sufficient documentation from various providers, the MCO, and DMAS of these noncompliance issues and any attempts at resolution. Members excluded from Medallion mandatory managed care through this provision may appeal the decision to DMAS.

B. The following individuals shall be excluded (as defined in 12VAC30-120-360 and the § 1915(b) managed care waiver) from participating in Medallion mandatory managed care. Individuals excluded from Medallion mandatory managed care shall include the following:

1. Individuals who are inpatients in state mental hospitals;

2. Individuals who are approved by DMAS as inpatients in long-stay hospitals, nursing facilities, or intermediate care facilities for individuals with intellectual disabilities;

3. Individuals who are placed on spend-down, which is the process of reducing countable income by deducting incurred medical expenses for medically needy individuals, as determined in the State Plan for Medical Assistance;

4. Individuals who are participating in the family planning waiver;

5. Prior to April 1, 2019, individuals younger than 21 years of age who are approved for DMAS residential facility Level C programs as defined in 12VAC30-130-860;

6. Individuals, other than students, who permanently live outside their area of residence, which is the member's address in the Medicaid eligibility file, for greater than 60 consecutive days except those individuals placed there for medically necessary services funded by the MCO;

7. Individuals who receive hospice services in accordance with DMAS criteria;

8. Individuals with insurance purchased through the Health Insurance Premium Payment Program (HIPP);

9. Individuals requesting exclusion who are inpatients in hospitals, other than those listed in subdivisions 1 and 2 of this subsection, at the scheduled time of MCO enrollment or who are scheduled for inpatient hospital stay or surgery within 30 calendar days of the MCO enrollment effective date. The exclusion shall remain effective until the first day of the month following discharge. This exclusion reason shall not apply to members admitted to the hospital while already enrolled in a department-contracted MCO;

10. Individuals who request exclusion during assignment to an MCO or within a time set by DMAS from the effective date of their MCO enrollment, who have been diagnosed with a terminal condition and who have a life expectancy of six months or less. The individual's physician must certify the life expectancy;

11. Individuals who have an eligibility period that is less than three months;

12. Individuals who have an eligibility period that is only retroactive; and

13. Children enrolled in the Virginia Birth-Related Neurological Injury Compensation Program established pursuant to Chapter 50 (§ 38.2-5000 et seq.) of Title 38.2 of the Code of Virginia.

C. Members enrolled with an MCO who subsequently meet one or more of the criteria of subsection B of this section during MCO enrollment shall be excluded from MCO participation as determined by DMAS. .

D. Individuals who are enrolled in localities that qualify for the rural exception may meet exclusion criteria if their PCP of record, as defined in 12VAC30-120-360, cannot or will not participate with the one MCO in the locality. Individual requests to be excluded from MCO participation in localities meeting the qualification for the rural exception must be made to DMAS for consideration on a case-by-case basis. Members enrolled in MCO rural exception areas shall not have open enrollment periods and shall not be afforded the 90-day window after initial enrollment during which they may make a health plan or program change.

Individuals excluded from Medallion mandatory managed care enrollment shall receive Medicaid services under the current fee-for-service system. When individuals no longer meet the criteria for exclusion, they shall be required to enroll in the appropriate managed care program.

E. Medallion mandatory managed care plans shall be offered to individuals, and individuals shall be enrolled in those plans. DMAS has sole responsibility for determining enrollment in the contractor's plan. DMAS utilizes an independent enrollment broker under contract to DMAS to assist members with making plan choices after initial preassignment and during open enrollment. An enrollment broker is an independent contractor that enrolls individuals in the contractor's plan and is responsible for the operation and documentation of a toll-free individual service helpline.

F. Members shall be enrolled as follows:

1. All eligible individuals, except those meeting one of the exclusions in subsection B of this section, shall be enrolled in Medallion mandatory managed care.

2. Individuals shall receive a Medicaid card from DMAS and shall be provided authorized medical care in accordance with DMAS procedures after Medicaid eligibility has been determined to exist.

3. Once individuals are enrolled in Medicaid, they will receive a letter indicating that they may select one of the contracted MCOs. These letters shall indicate an assigned MCO, determined as provided in subsection G of this section, in which the member will be enrolled if he does not make a selection within a period specified by DMAS of not less than 30 days. Members who are enrolled in one mandatory MCO program who immediately become eligible for another mandatory MCO program are able to maintain consistent enrollment with the member's currently assigned MCO if available. These members will receive a notification letter including information regarding their ability to change health plans under the new program.

4. Any newborn whose mother is enrolled with an MCO at the time of birth shall be considered a member of that same MCO for the newborn enrollment period.

a. This requirement does not preclude the member, once the member is assigned a Medicaid identification number, from disenrolling from one MCO to enrolling with another in accordance with subdivision H 1 of this section.

b. The newborn's continued enrollment with the MCO is not contingent upon the mother's enrollment. Additionally, if the MCO's contract is terminated in whole or in part, the MCO shall continue newborn coverage if the child is born while the contract is active until the newborn receives a Medicaid number or for the newborn enrollment period, whichever timeframe is earlier. Newborns who remain eligible for participation in Medallion mandatory managed care will be reenrolled in an MCO through the assignment process upon receiving a Medicaid identification number.

c. Any newborn whose mother is enrolled in an MCO at the time of birth shall receive a Medicaid identification number prior to the end of the newborn enrollment period in order to maintain the newborn's enrollment in an MCO.

5. Individuals who lose then regain eligibility for Medallion mandatory managed care within 60 days will be reenrolled into their previous MCO without going through assignment and selection.

G. Individuals who do not select an MCO as described in subdivision F 3 of this section shall be assigned to an MCO as follows:

1. Individuals are assigned through a system algorithm based upon the member's history with a contracted MCO.

2. Individuals not assigned pursuant to subdivision 1 of this subsection shall be assigned to the MCO of another family member if applicable.

3. Individuals who live in rural exception areas as defined in 12VAC30-120-360 shall enroll with the one available MCO. These individuals shall receive an assignment notification for enrollment into the MCO. Individuals in rural exception areas who are assigned to the one MCO may request exclusion from MCO participation if their PCP of record, as defined in 12VAC30-120-360, cannot or will not participate with the one MCO in the locality. Individual requests to be excluded from MCO participation in rural exception localities must be made to DMAS for consideration on a case-by-case basis.

4. All other individuals shall be assigned to an MCO on a basis of approximately equal number by MCO in each locality.

5. All eligible members are automatically assigned to a contracted MCO in their localities. Members are allowed 90 days after the effective date of initial enrollment to change to another MCO that participates in the geographic area where the member lives. Members residing in localities qualifying for a rural exception shall not be afforded the 90-day window after initial enrollment during which they may make a health plan or program change.

6. DMAS shall have the discretion to use an alternate strategy for enrollment or transition of enrollment from the method described in this section for expansions, retractions, or changes to member populations, geographical areas, procurements, or any or all of these; such alternate strategy shall comply with federal waiver requirements. "Retractions" means the departure of an enrolled managed care organization from any one or more localities as provided in this section.

H. Following the member's initial enrollment into an MCO, the member shall be restricted to the MCO until the next open enrollment period, unless appropriately disenrolled or excluded by the department, as defined in 12VAC30-120-360.

1. During the first 90 days of enrollment in an initial MCO, a member may disenroll from that MCO to enroll into another MCO for any reason. Such disenrollment shall be effective no later than the first day of the second month after the month in which the member requests disenrollment.

2. During the remainder of the enrollment period, the member may only disenroll from one MCO into another MCO upon determination by DMAS that good cause exists as determined under subsection J of this section.

I. The department shall conduct an annual open enrollment for all Medallion mandatory managed care members with the exception of those members who live in a designated rural exception area. The open enrollment period shall be the 60 days before the end of the enrollment period. Prior to the open enrollment period, DMAS will inform the member of the opportunity to remain with the current MCO or change to another MCO, without cause, for the following year. Enrollment selections will be effective on the first day of the next month following the open enrollment period. Members who do not make a choice during the open enrollment period will remain with their current MCO selection.

J. Disenrollment for cause may be requested at any time and the disenrollment reasons shall be in accordance with 42 CFR 438.56 (d)(2)(v).

1. The request may be made orally or in writing to DMAS and shall cite the reason or reasons why the member wishes to disenroll. Cause for disenrollment shall be in accordance with 42 CFR 438.56(d)(2), which includes the following reasons:

a. A member's desire to seek services from a federally qualified health center that is not under contract with the member's current MCO, and the member requests a change to another MCO that subcontracts with the desired federally qualified health center;

b. Performance or nonperformance of service to the member by an MCO or one or more of its network providers that is deemed by the DMAS external quality review organizations to be below the generally accepted community practice of health care. This may include poor quality care;

c. Lack of access to a primary care physician or necessary specialty services covered under the State Plan or lack of access to network providers experienced in dealing with the member's health care needs;

d. A member has a combination of complex medical factors that, in the sole discretion of DMAS, would be better served under another contracted MCO;

e. The member moves out of the MCO's service area;

f. The MCO does not, because of moral or religious objections, cover the service the member seeks; or

g. The member needs related services to be performed at the same time; not all related services are available within the network, and the member's primary care provider or another provider determines that receiving the services separately would subject the member to unnecessary risk.

2. DMAS shall determine whether cause exists for disenrollment. Written responses shall be provided within a timeframe set by department policy; however, the effective date of an approved disenrollment shall be no later than the first day of the second month following the month in which the member files the request in compliance with 42 CFR 438.56.

3. Cause for disenrollment shall be deemed to exist and the disenrollment shall be granted if DMAS fails to take final action on a valid request prior to the first day of the second month after the request.

4. The DMAS determination concerning cause for disenrollment may be appealed by the member in accordance with the DMAS client appeals process at 12VAC30-110-10 through 12VAC30-110-370.

5. The current MCO shall provide within two working days of a request from DMAS information necessary to determine cause.

6. Members enrolled with an MCO who subsequently meet one or more of the exclusions in subsection B of this section during MCO enrollment shall be excluded from Medallion as determined appropriate by DMAS.

K. In accordance with 42 CFR 438.3(q)(5) and 42 CFR 438.56(c)(2), a member has the right to disenroll from the contractor's plan without cause at the following times:

1. During the 90 days following the date of the member's initial enrollment into the MCO or during the 90 days following the date DMAS sends the member notice of that enrollment, whichever is later.

2. At least once every 12 months thereafter.

3. Upon automatic reenrollment under subsection G of this section if the temporary loss of Medicaid eligibility has caused the beneficiary to miss the annual disenrollment opportunity.

4. When DMAS imposes the intermediate sanction specified in 42 CFR 438.702(a)(4).

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 5, eff. January 1, 1997; amended, Virginia Register Volume 14, Issue 6, eff. January 7, 1998; Volume 14, Issue 18, eff. July 1, 1998; Volume 15, Issue 18, eff. July 1, 1999; Errata, 15:19 VA.R. 2502 June 7, 1999; amended, Virginia Register Volume 19, Issue 3, eff. December 1, 2002; Volume 19, Issue 23, eff. August 27, 2003; Volume 21, Issue 11, eff. March 10, 2005; Volume 22, Issue 8, eff. eff. April 3, 2006; Volume 25, Issue 11, eff. March 4, 2009; Volume 30, Issue 6, eff. January 2, 2014; Volume 30, Issue 7, eff. January 2, 2014; Volume 30, Issue 12, eff. March 28, 2014; Volume 32, Issue 22, eff. July 27, 2016; Volume 35, Issue 14, eff. April 18, 2019.

12VAC30-120-380 Medallion MCO responsibilities

A. The MCO shall provide, at a minimum, all medically necessary covered services provided under the State Plan for Medical Assistance and further defined by written federal and state regulations, the Medallion contract, policies, and instructions, except as otherwise modified or excluded in this part.

1. Nonemergency services provided by hospital emergency departments shall be covered by MCOs in accordance with rates negotiated between the MCOs and the hospital emergency departments.

2. Services that shall be provided outside the MCO network shall include those services identified and defined by the contract between DMAS and the MCO. Services reimbursed by DMAS include dental and orthodontic services for children younger than 21 years of age, dental services for others as described in 12VAC30-50-190, and school health services.

3. The MCOs shall pay for emergency services and family planning services and supplies whether such services are provided inside or outside the MCO network.

B. Early and periodic screening, diagnostic, and treatment (EPSDT) services shall be covered by the MCO and defined by the contract between DMAS and the MCO. The MCO shall have the authority to determine the provider of service for EPSDT screenings.

C. The MCOs shall report data to DMAS under the contract requirements, which may include data reports, report cards for members, and ad hoc quality studies performed by the MCO or third parties.

D. Documentation requirements.

1. The MCO shall comply with the records retention requirements as outlined in the contract. The MCO shall furnish such required information to DMAS, the Attorney General of Virginia or his authorized representatives, or the State Medicaid Fraud Control Unit on request and in the form requested.

2. Each MCO shall comply with the member rights and protections stipulated in the contract and as identified in 42 CFR 438 Subpart C.

E. The MCO shall comply with the contract and 42 CFR 438 Subparts E and H to ensure that the health care provided to its members meets all applicable federal and state mandates, community standards for quality, and standards developed pursuant to the DMAS managed care quality program.

F. The MCOs shall promptly provide or arrange for the provision of all required services as specified in the contract between the Commonwealth and the MCO. Medical evaluations shall be available within 48 hours for urgent care and within 30 days for routine care. On-call clinicians shall be available 24 hours per day, seven days per week.

G. The MCOs shall meet the standards specified in 42 CFR 438, Subpart D by DMAS for sufficiency of provider networks as specified in the contract between the Commonwealth and the MCO.

H. Each MCO and its subcontractors shall have in place and follow written policies and procedures for processing requests for initial and continuing authorizations of service. Each MCO and its subcontractors shall ensure that any decision to deny a service authorization request or to authorize a service in an amount, duration, or scope that is less than requested be made by a health care professional who has appropriate clinical expertise in treating the member's condition or disease. Each MCO and its subcontractors shall have in effect mechanisms to ensure consistent application of review criteria for authorization decisions and shall consult with the requesting provider when appropriate.

I. In accordance with 42 CFR 447.50 through 42 CFR 447.90, MCOs shall not impose any cost sharing obligations on members except as set forth in 12VAC30-20-150 and 12VAC30-20-160.

J. An MCO may not prohibit or otherwise restrict a health care professional acting within the lawful scope of practice from advising or advocating on behalf of a member who is his patient in accordance with 42 CFR 438.102.

K. An MCO that would otherwise be required to reimburse for or provide coverage of a counseling or referral service is not required to do so if the MCO objects to the service on moral or religious grounds and furnishes information about the service it does not cover in accordance with 42 CFR 438.102.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 5, eff. January 1, 1997; amended, Virginia Register Volume 14, Issue 6, eff. January 7, 1998; Volume 19, Issue 3, eff. December 1, 2002; Volume 19, Issue 23, eff. August 27, 2003; Volume 21, Issue 11, eff. March 10, 2005; Volume 22, Issue 23, eff. August 23, 2006; Volume 25, Issue 11, eff. March 4, 2009; Volume 26, Issue 8, eff. January 21, 2010; Volume 30, Issue 7, eff. January 2, 2014Volume 31, Issue 9, eff. February 13, 2015; Volume 32, Issue 22, eff. July 27, 2016; Volume 35, Issue 14, eff. April 18, 2019.

12VAC30-120-385 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 14, Issue 18, eff. July 1, 1998; repealed, Virginia Register Volume 19, Issue 3, eff. December 1, 2002.

12VAC30-120-390 Payment rate for MCOs

The payment rate to MCOs that participate in the Medallion mandatory managed care program shall be set by negotiated contracts and in accordance with 42 CFR 438.4 through 42 CFR 438.8 and other pertinent federal regulations.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 5, eff. January 1, 1997; amended, Virginia Register Volume 19, Issue 3, eff. December 1, 2002; Volume 19, Issue 23, eff. August 27, 2003; Volume 32, Issue 22, eff. July 27, 2016; Volume 35, Issue 14, eff. April 18, 2019.

12VAC30-120-395 Preauthorized, emergency, and post-stabilization services and payment rate for care provided by out-of-network providers

The MCOs shall pay for preauthorized, emergency, and post-stabilization services to members in compliance with the contract and 42 CFR 438.114. Preauthorized, emergency, and post-stabilization services provided to a managed care member by a provider or facility not participating in the MCO's network will be reimbursed according to the current Medicaid fee schedule. This reimbursement shall be considered payment in full to the provider or facility of emergency services.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 5, eff. January 1, 1997; amended, Virginia Register Volume 19, Issue 3, eff. December 1, 2002; Volume 19, Issue 23, eff. August 27, 2003; Volume 32, Issue 22, eff. July 27, 2016; Volume 35, Issue 14, eff. April 18, 2019.

12VAC30-120-400 Quality control and utilization review

A. DMAS shall rigorously monitor the quality of care provided by the MCOs. DMAS and the MCOs shall comply with (i) the contract; (ii) 42 CFR 438 Subpart E, entitled Quality Measurement and Improvement: External Quality Review; and (iii) the MCO standards identified in 42 CFR 438 Subpart D, entitled MCO, PIHP, and PAHP Standards. DMAS shall monitor the MCOs to determine their compliance with the contract, 42 CFR Subpart A, and all other relevant sections of 42 CFR Part 438 (Managed Care) as follows:

1. If the MCO fails substantially to provide the medically necessary items and services required under law or under the contract to be provided to an enrolled recipient and the failure has adversely affected or has substantial likelihood of adversely affecting the individual.

2. If the MCO engages in any practice that discriminates against individuals on the basis of their health status or requirements for health care services, including expulsion or refusal to reenroll an individual, or any practice that could reasonably be expected to have the effect of denying or discouraging enrollment (except as permitted by § 1903(m) of the Social Security Act (42 USC § 1396(m)) by eligible individuals whose medical conditions or histories indicate a need for substantial future medical services.

3. If the MCO misrepresents or falsifies information that it furnishes, under § 1903(m) of the Social Security Act (42 USC § 1396b(m)) to CMS, DMAS, an individual, or any other entity.

4. If the MCO fails to comply with the requirements of 42 CFR 417.479(d) through 42 CFR 417.479(g) relating to physician incentive plans or fails to submit to DMAS its physician incentive plans as required or requested in 42 CFR 434.70.

5. If the MCO imposes on members premiums or charges that are in excess of the premiums or charges permitted under the Medicaid program.

B. DMAS shall ensure that data on performance and patient results are collected.

C. DMAS shall ensure that quality outcomes information is provided to MCOs. DMAS shall ensure that changes that are determined to be needed as a result of quality control or utilization review are made.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 5, eff. January 1, 1997; amended, Virginia Register Volume 14, Issue 5, eff. January 1, 1998; Volume 19, Issue 3, eff. December 1, 2002; Volume 19, Issue 23, eff. August 27, 2003; Volume 21, Issue 11, eff. March 10, 2005; Volume 32, Issue 22, eff. July 27, 2016; Volume 35, Issue 14, eff. April 18, 2019.

12VAC30-120-410 Sanctions

A. If DMAS determines that an MCO is not in compliance with applicable state or federal laws or regulations (including the requirements of or pursuant to § 1932(e)(1) of the Social Security Act (the Act), 12VAC30-120-380, or 42 CFR 438 Subpart I) or the MCO contract, DMAS may impose sanctions on the MCO pursuant to § 1932(e) of the Act and this section. The sanctions may include:

1. Limiting enrollments in the MCO by freezing voluntary member enrollments;

2. Freezing DMAS assignment of members to the MCO;

3. Limiting MCO enrollment to specific areas;

4. Denying, withholding, or retracting payments to the MCO;

5. Terminating the MCO's contract as provided in § 1932(e)(4) of the Act;

6. Civil monetary penalties as specified in 42 CFR 438.704; and

7. Appointment of temporary management for an MCO as provided in 42 CFR 438.706.

B. In the case of an MCO that has repeatedly failed to meet the requirements of §§ 1903(m) and 1932(e) of the Social Security Act, DMAS shall, regardless of what other sanctions are imposed, impose the following sanctions:

1. Appoint a temporary manager to:

a. Oversee the operation of the Medicaid managed care organization upon a finding by DMAS that there is continued egregious behavior by the organization or there is a substantial risk to the health of members; or

b. Ensure the health of the organization's members if there is a need for temporary management while (i) there is an orderly termination or reorganization of the organization or (ii) improvements are made to remedy the violations found under subsection A of this section. Temporary management under this subdivision may not be terminated until DMAS has determined that the MCO has the capability to ensure that the violations shall not recur.

2. Permit members who are enrolled with the MCO to disenroll without cause. If this sanction is imposed, DMAS shall be responsible for notifying such members of the right to disenroll.

C. Prior to terminating a contract as permitted under § 1932(e)(4) of the Act, DMAS shall provide the MCO with a hearing. DMAS shall not provide an MCO with a predetermination hearing before the appointment of a temporary manager under subdivision B 1 of this section.

D. Prior to imposing any sanction other than termination of the MCO's contract, DMAS shall provide the MCO with notice, develop procedures with which the MCO must comply to eliminate specific sanctions, and provide such other due process protections as the Commonwealth may provide.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 5, eff. January 1, 1997; amended, Virginia Register Volume 14, Issue 18, eff. July 1, 1998; Volume 19, Issue 3, eff. December 1, 2002; Volume 19, Issue 23, eff. August 27, 2003; Volume 21, Issue 11, eff. March 10, 2005; Volume 32, Issue 22, eff. July 27, 2016; Volume 35, Issue 14, eff. April 18, 2019.

12VAC30-120-420 Member grievances and appeals

A. The MCOs shall comply with (i) the Grievance and Appeal System as identified in 42 CFR 438 Subpart F, (ii) the Enrollee Rights and Protections requirements in 42 CFR 438 Subpart C, (iii) the Medallion contract between DMAS and the MCO, and (iv) any other applicable state or federal statutory or regulatory requirements.

B. MCOs shall at (i) the initiation of new member enrollment, (ii) the initiation of new provider or subcontractor contracts, or (iii) the request of the member, provide to every member the information described in 42 CFR 438.10(g) concerning grievance and appeal rights and procedures.

C. Disputes between the MCO and the member concerning any aspect of service delivery, including medical necessity and specialist referral, shall be resolved through a verbal or written grievance or appeals process operated by the MCO or through the DMAS appeals process. A provider or other representative who has the member's written consent may act on behalf of a member in the MCO grievance or appeals or the DMAS appeals process.

1. The member, provider, or representative acting on behalf of the member with the member's written consent may file an oral or written grievance or internal appeal with the MCO. The MCO must accept grievances filed at any time. Internal appeal requests must be submitted within 60 days from the date of the notice of adverse benefit determination. Oral requests for internal appeals must be followed up in writing by the member, provider, or the representative acting on behalf of the member with the member's consent, unless the request is for an expedited internal appeal.

2. The member must exhaust the MCO's internal appeals process before appealing to the DMAS Appeals Division. The member may also file a written request for a standard or expedited internal appeal of the MCO's adverse benefit determination with the DMAS Appeals Division within 120 days of the member's receipt of the MCO's internal appeal decision, in accordance with 42 CFR 431 Subpart E; 42 CFR Part 438 Subpart F; and 12VAC30-110-10 through 12VAC30-110-370.

3. As specified in 12VAC30-110-100, pending the resolution of a grievance, internal appeal, or appeal filed by a member or his representative (including a provider acting on behalf of the member) prior to the effective date of the adverse benefit determination, coverage shall not be terminated or reduced for the member for any reason that is the subject of the grievance or appeal.

4. The MCO shall ensure that neither the individuals nor agents, nor a subordinate of any such individual, who makes decisions on grievances and internal appeals were involved in any previous level of review or decision making. Additionally, where the reason for the grievance or internal appeal involves clinical issues or relates to a denial of a request for an expedited appeal, or where the appeal is based on a lack of medical necessity, the MCO shall ensure that the decision makers are health care professionals with the appropriate clinical expertise in treating the member's condition or disease.

5. The MCO shall provide the member and any representative a reasonable opportunity in person and in writing to present evidence and testimony and to make legal and factual arguments in accordance with 42 CFR 438.406(b)(4). The MCO shall inform the member of the limited time available for this sufficiently in advance of the resolution timeframe for appeals in accordance with 42 CFR 438.406(b)(4).

6. The MCO shall provide the member and any representative the member's case file, including medical records, and any new or additional evidence considered, relied upon, or generated by the MCO in connection with the appeal of the adverse benefit determination. This information must be provided free of charge and sufficiently in advance of the resolution timeframe for appeals in accordance with 42 CFR 438.406(b)(5).

D. The MCO shall develop written materials describing the grievance or appeals system and its procedures and operation.

E. The MCO shall maintain a recordkeeping, reporting, and tracking system for complaints, grievances, and appeals that complies with the Medallion contract between DMAS and the MCO. The system shall include a copy of the original complaint, grievance, or internal appeal; the decision; the nature of the decision; and data on the number of internal appeals filed, the average time to resolve internal appeals, and the total number of internal appeals open as of the reporting date. This system shall distinguish Medicaid from commercial members if the MCO does not have a separate system for Medicaid members.

F. At the time of enrollment and at the time of any adverse benefit determination, the MCO shall notify the member in writing that:

1. An adverse benefit determination may be resolved through a system of grievances and appeals, first within the MCO and then through the DMAS client appeals process;

2. Members have the right to request an expedited internal appeal;

3. Members shall exhaust their internal appeals with the MCO before being given the right to appeal to DMAS; and

4. The MCO shall promptly provide grievance or appeal forms, reasonable assistance, and written procedures to members who wish to register written grievances or appeals, including auxiliary aids and services upon request such as providing interpreter services and toll-free numbers that have adequate TTY/TTD and interpreter capability.

G. The MCO shall issue grievance or internal appeal decisions as defined by 42 CFR 438.408 and the contract between DMAS and the MCO. Oral grievance decisions are not required to be in writing.

H. The MCO shall issue standard internal appeal decisions within 30 days from the date of initial receipt of the internal appeal in accordance with 42 CFR 438.408 and as defined by the Medallion contract between DMAS and the MCO. This timeframe may be extended by up to 14 days under the requirements of 42 CFR 438.408. The internal appeal decision shall be in writing and shall include the following:

1. The decision reached, the results, and the date of the decision reached by the MCO;

2. The reasons for the decision;

3. The policies or procedures that provide the basis for the decision;

4. For internal appeals not resolved wholly in favor of the member:

a. A clear explanation of further appeal rights and a timeframe for filing an internal appeal; and

b. The right to continue to receive benefits in accordance with 42 CFR 438.420 pending a hearing and how to request continuation of benefits.

The member may be held liable for the cost of those benefits if the hearing decision upholds the contractor's adverse benefit determination.

I. An expedited appeal decision shall be issued as expeditiously as the member's condition requires and within 72 hours from receipt of the internal appeal request in cases of medical emergencies in which delay could result in death or serious injury to a member. Extensions to these timeframes shall be allowed in accordance with 42 CFR 438.408 and as defined by the Medallion contract between DMAS and the MCO. Written confirmation of the decision shall promptly follow the verbal notice of the expedited decision.

J. If the MCO fails to adhere to the internal appeals notice and timing requirements of this section, the member is deemed to have exhausted the MCO's internal appeals process and may file an internal appeal with DMAS.

K. Any adverse benefit determination upheld in whole or in part by the internal appeal decision issued by the MCO may be appealed by the member to DMAS in accordance with the DMAS appeals regulations at 12VAC30-110-10 through 12VAC30-110-370. DMAS shall conduct an evidentiary hearing in accordance with the Client Appeals regulations at 12VAC30-110-10 through 12VAC30-110-370 and shall not base any appealed decision on the record established by any internal appeal decision of the MCO. The MCO shall comply with the DMAS appeal decision. The DMAS decision in these matters shall be final and shall not be subject to appeal by the MCO.

L. The MCO shall provide information necessary for any DMAS appeal within timeframes established by DMAS.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396.
• Historical Notes: Derived from Virginia Register Volume 13, Issue 5, eff. January 1, 1997; amended, Virginia Register Volume 14, Issue 18, eff. July 1, 1998; Volume 19, Issue 3, eff. December 1, 2002; Volume 19, Issue 23, eff. August 27, 2003; Volume 21, Issue 11, eff. March 10, 2005; Volume 32, Issue 22, eff. July 27, 2016; Volume 35, Issue 14, eff. April 18, 2019

12VAC30-120-430 Provider grievances, reconsiderations, and appeals

A. The MCOs shall comply with the requirements of the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia), the provider appeals regulations at 12VAC30-20-500 through 12VAC30-20-560, the Medallion contract between DMAS and the MCO, and any other applicable state or federal statutory or regulatory requirements.

B. The MCOs shall have a grievance system established to respond to grievances made by network providers. Network provider grievances are not appealable to the DMAS Appeals Division.

C. MCOs shall, at the initiation of new network provider contracts, provide to every network provider the information described in this section concerning grievance, reconsideration, and appeal rights and procedures.

D. Disputes between the MCO and the network provider concerning any aspect of reimbursement shall be resolved through a verbal or written grievance or reconsideration process operated by the MCO or through the DMAS appeals process. A network provider or representative that is authorized by the network provider may act on behalf of a network provider in the MCO grievance or reconsideration or the DMAS appeals process.

E. Disputes arising solely from the MCO's denial or termination of a provider's enrollment in the MCO's network are not appealable to the DMAS Appeals Division.

F. If a network provider has rendered services to a member and has been denied authorization or reimbursement for the services or has received reduced authorization or reimbursement, that provider may request a reconsideration of the denied or reduced authorization or reimbursement. Before appealing to DMAS, network providers must first exhaust all MCO reconsideration processes. The MCO's final denial letter must include a statement that the provider has exhausted its reconsideration rights with the MCO and that the next level of appeal is with DMAS. The final denial letter must include the appeal rights to DMAS in accordance with the provider appeals regulations at 12VAC30-20-500 through 12VAC30-20-560.

G. All network provider appeals to DMAS must be submitted to the DMAS Appeals Division in writing and within 30 days of the MCO's last date of denial.

H. The MCO shall provide information necessary for any DMAS appeal within timeframes established by DMAS.

I. The MCO shall comply with the DMAS appeal decision. A DMAS appeal decision is not appealable by the MCO.

J. The MCO shall maintain a recordkeeping, reporting, and tracking system for complaints, grievances, and reconsiderations that complies with the Medallion contract between DMAS and the MCO. The system shall include a copy of the original complaint, grievance, or reconsideration; the decision; the nature of the decision; and data on the number of reconsiderations filed, the average time to resolve reconsiderations, and the total number of reconsiderations open as of the reporting date.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396.
• Historical Notes: Derived from Virginia Register Volume 12, Issue 9, eff. January 1, 1996; reserved, Virginia Register Volume 13, Issue 5, eff. January 1, 1997; amended Virginia Register Volume 35, Issue 14, eff. April 18, 2019.

12VAC30-120-440 [Reserved]

Historical Notes

Reserved, Virginia Register Volume 13, Issue 5, eff. January 1, 1997.

Part VII Commonwealth Coordinated Care Plus Program

12VAC30-120-450 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 12, Issue 20, eff. August 1, 1996; repealed, Virginia Register Volume 29, Issue 25, eff. September 26, 2013.

12VAC30-120-460 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 12, Issue 20, eff. August 1, 1996; repealed, Virginia Register Volume 29, Issue 25, eff. September 26, 2013.

12VAC30-120-470 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 12, Issue 20, eff. August 1, 1996; repealed, Virginia Register Volume 29, Issue 25, eff. September 26, 2013.

12VAC30-120-480 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 12, Issue 20, eff. August 1, 1996; repealed, Virginia Register Volume 29, Issue 25, eff. September 26, 2013.

12VAC30-120-490 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 14, Issue 18, eff. July 1, 1998; amended, Virginia Register Volume 19, Issue 18, eff. July 1, 2003; repealed, Virginia Register Volume 22, Issue 10, eff. February 22, 2006.

12VAC30-120-600 Definitions

The following words and terms when used in this part shall have the following meanings unless the context clearly indicates otherwise:

"Adverse action" means the denial, suspension, or reduction in services or the denial or retraction, in whole or in part, of payment for a service that has already been rendered.

"Adverse benefit determination" means, consistent with 42 CFR 438.400, any of the following: (i) the denial or limited authorization of a requested service, including determinations based on the type or level of service, requirements for medical necessity, appropriateness, setting, or effectiveness of a covered benefit; (ii) the reduction, suspension, or termination of a previously authorized service; (iii) the denial, in whole or in part, of payment for a service; (iv) the failure to provide services in a timely manner, as defined by the state; (v) the failure of an MCO, PIHP, or PAHP to act within the timeframes provided in 42 CFR 438.408(b)(1) and 42 CFR 438.408(b)(2) regarding the standard resolution of grievances and appeals; (vi) for a resident of a rural area with only one MCO, the denial of an enrollee's request to exercise the enrollee's right under 42 CFR 438.52(b)(2)(ii) to obtain services outside the network; or (vii) the denial of an enrollee's request to dispute a financial liability, including cost sharing, copayments, premiums, deductibles, coinsurance, and other enrollee financial liabilities.

"Appellant" means an applicant for or recipient of Medicaid benefits who seeks to challenge an adverse benefit determination taken by the participating plan, subcontractor, service provider, or DMAS regarding eligibility for services and payment determinations.

"Authorized representative" means the same as set forth in 12VAC30-110-1380 and 12VAC30-110-1390.

"Centers for Medicare and Medicaid Services" or "CMS" means the federal agency of the U.S. Department of Health and Human Services that is responsible for the administration of Titles XVIII, XIX, and XXI of the Social Security Act.

"Commonwealth Coordinated Care Plus program" or "CCC Plus" means the department's mandatory integrated care initiative for certain qualifying individuals, including dual eligible individuals and individuals receiving long-term services and supports (LTSS). The CCC Plus program includes individuals who receive services through nursing facility (NF) care or from the four home and community-based services (HCBS) § 1915(c) waivers .

"Continuity of care period" means a set period of time during which the MCO shall ensure a seamless transition from Medicaid FFS, or from another MCO, for all members upon enrollment into a plan.

"Contractor" means a managed care health plan selected by DMAS and contracted to participate in the CCC Plus program.

"Covered services" means the set of required services offered by the participating plan.

"Department of Medical Assistance Services," "department," or "DMAS" means the Virginia Department of Medical Assistance Services, the single state agency for the Medicaid program in Virginia that is responsible for implementation and oversight of CCC Plus.

"Disenrollment" means the process of changing enrollment from one participating plan to another participating plan or the process of being excluded from CCC Plus by the department as described in 12VAC30-120-610.

"Division" or "Appeals Division" means the Appeals Division of the Department of Medical Assistance Services.

"Dual eligible" means a Medicare member who receives Medicare Parts A, B, and D benefits and also receives full Medicaid benefits.

"Effective date" means the date on which a participating plan's coverage begins for a member.

"Enrollment" means assignment of an individual to a health plan by the department in accordance with the terms of the contract with the participating plan. This does not include attaining eligibility for the Medicaid program.

"Enrollment broker" means an independent contractor that enrolls individuals in the contractor's plan and is responsible for the operation and documentation of a toll-free individual service helpline. The responsibilities of the enrollment broker include individual education and MCO enrollment and assistance with and tracking of individuals' complaints and their resolutions and may include individual marketing and outreach.

"Enrollment period" means the time that a member is actually enrolled in a participating plan.

"External appeal" means an appeal, subsequent to the participating plan internal appeal or reconsideration decision, to the state fair hearing process (for a member appeal) or informal appeals process (for a provider appeal).

"Fee-for-service" or "FFS" means the traditional health care payment system in which physicians and other providers receive a payment for each service they provide.

"Final decision" means a written determination by a department hearing officer from an appeal of an internal appeal decision that is binding on the department, unless modified during or after the judicial process.

"Handbook" means a document prepared by the MCO and provided to the member that is consistent with the requirements of 42 CFR 438.10 and the CCC Plus contract and includes information about all the services covered by that plan.

"Hearing officer" means an impartial decision maker who conducts evidentiary state fair hearings for member appeals on behalf of the department.

"Internal appeal" means an oral or a written request to the MCO by a member, a member's authorized representative, or a provider acting on behalf of the member and with the member's written consent for review of a contractor's adverse benefit determination. The internal appeal is the only level of appeal with the MCO and must be exhausted by a member or deemed exhausted according to 42 CFR 438.408(c)(3) before the member may initiate a state fair hearing.

"Long-term services and supports" or "LTSS" means a variety of services and supports that (i) help elderly s members and s members with disabilities who need assistance to perform activities of daily living and instrumental activities of daily living to improve the quality of their lives and (ii) are provided over an extended period, predominantly in homes and communities, but also in facility-based settings such as nursing facilities.

"MCO" means a health plan selected to participate in Virginia's CCC Plus program. "MCO" means the same as "participating plan."

"Medicaid" means the program of medical assistance benefits under Title XIX of the Social Security Act.

"Medically complex" means those who have a complex medical or behavioral health condition and a functional impairment or an intellectual or developmental disability.

"Medically necessary" or "medical necessity" means an item or service provided for the diagnosis or treatment of an enrollee's condition consistent with standards of medical practice and in accordance with Virginia Medicaid policy (12VAC30-130-600 et seq.) or EPSDT criteria, for those younger than 21 years of age, in accordance with 42 CFR 441 Subpart B (§§ 50 through 62), 42 CFR 438.210, and 42 CFR 440.230.

"Medicare" means Title XVIII of the Social Security Act, the federal health insurance program for people age 65 years or older, people younger than 65 years of age who have certain disabilities, and people with end stage renal disease or amyotrophic lateral sclerosis.

"Member" means an individual who has enrolled in a participating plan to receive services under CCC plus.

"Member appeal" means a member's request for review of an adverse benefit determination.

"Network provider" means a doctor, hospital, or other health care provider that participates or contracts with a participating plan and, as a result, agrees to accept a mutually-agreed upon payment amount or fee schedule as payment in full for covered services that are rendered to eligible s members.

"Nursing facility" means any skilled nursing facility, skilled care facility, intermediate care facility, nursing care facility, or nursing facility, whether freestanding or a portion of a freestanding medical care facility, that is certified for participation as a Medicare or Medicaid provider, or both, pursuant to Title XVIII and Title XIX of the Social Security Act, as amended, and § 32.1-137 of the Code of Virginia.

"Open enrollment" means the timeframe in which members are permitted to change from one MCO to another without cause.

"Participating plan" means the same as "MCO."

"Previously authorized" means, in relation to continuation of benefits, as described in 42 CFR 438.420, a prior approved course of treatment.

"Primary care provider" means a practitioner who provides preventive and primary medical care and certifies service authorizations and referrals for medically necessary specialty services. Primary care providers may include pediatricians, family and general practitioners, internists, obstetricians or gynecologists, geriatricians, specialists who perform primary care functions (such as surgeons), and clinics, including local health departments, federally qualified health centers, and rural health clinics.

"Program of All-Inclusive Care for the Elderly" or "PACE" means the program in which the PACE provider provides the entire spectrum of health services (preventive, primary, and acute) and long-term services and supports to its s members without limit as to duration or cost of services pursuant to 12VAC30-50-320 et seq.

"Provider appeal" means an appeal to the department filed by a Medicaid-enrolled or network service provider that has already provided a service to a member and has received an adverse reconsideration decision regarding service authorization, payment, or audit result.

"Reconsideration" means a provider's request to the MCO for review of an adverse action related to service authorization or payment. The MCO's reconsideration decision is a prerequisite to a provider's filing of an appeal to the Appeals Division.

"Remand" means the return of a case by the department's hearing officer to the MCO for further review, evaluation, and action.

"Reverse" means to overturn the MCO's internal appeal decision and to direct that the MCO fully approve the amount, duration, and scope of requested services.

"Social Security Act" means the federal act, codified through Chapter 7 of Title 42 of the United States Code, that established social insurance programs including Medicare and Medicaid.

"State fair hearing" means the DMAS evidentiary hearing as administered by the Appeals Division. A state fair hearing is conducted by a department hearing officer to allow a member the opportunity to present the member's concerns with or objections to the participating plan's internal appeal decision.

"Subcontractor" means an entity that has contracted with the contractor to perform part of the responsibilities within the CCC Plus program. All subcontractors shall be approved by DMAS.

"Sustain" means to uphold the MCO's appeal decision.

"Withdraw" means a written request from the member or the 's member's authorized representative for the department to terminate the member appeal.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-610 CCC Plus mandatory managed care members enrollment process

A. The following individuals shall be enrolled in CCC Plus per the CCC Plus § 1915(b) waiver:

1. Dual eligible individuals with Medicare A or B coverage and full Medicaid coverage.

2. Non-dual eligible individuals who receive long-term services and supports through an institution, the CCC Plus waiver , Building Independence waiver, Community Living waiver, and Family and Individual Supports waiver.

Those enrolled in the Building Independence, Community Living, and Family and Individual Supports waivers will continue to receive their LTSS including LTSS related transportation services through Medicaid fee-for-service.

3. All individuals classified as aged, blind, or disabled (ABD) without Medicare and not receiving LTSS.

4. Individuals who qualify for and enroll under Medicaid expansion who have been identified as medically complex.

B. The following individuals shall be excluded from enrollment in CCC Plus:

1. Individuals enrolled in another DMAS managed care program (e.g., Medallion, FAMIS, and FAMIS MOMS).

2. Individuals enrolled in a PACE program.

3. Newborns whose mothers are CCC Plus members on their date of birth.

4. Individuals who are in limited coverage groups, such as:

a. Dual eligible individuals without full Medicaid benefits, such as:

(1) Qualified Medicare beneficiaries;

(2) Special low-income Medicare beneficiaries;

(3) Qualified disabled working individuals; or

(4) Qualifying individuals for whom Medicaid pays the Part B premium.

b. Individuals enrolled in Plan First who do not meet eligibility criteria for Medicaid expansion.

5. Individuals enrolled in a Medicaid-approved hospice program at the time of enrollment. However, if an individual enters a hospice program while enrolled in CCC Plus, the member will remain enrolled in CCC Plus.

6. Individuals who live on Tangier Island.

7. Individuals younger than 21 years of age who are approved for DMAS psychiatric residential treatment center (RTC) Level C programs as defined in 12VAC30-130-860. Any individual admitted to an RTC Level C program for behavioral health services will be temporarily excluded from CCC Plus until after they are discharged. RTC Level C services may be transitioned to the CCC Plus program in the future.

8. Individuals with end stage renal disease (ESRD) and in fee-for-service at the time of enrollment will be automatically enrolled into CCC Plus but may request to be disenrolled and remain in fee-for-service. The department will exclude these individuals if requested by the member within the first 90 days of CCC Plus enrollment. However, a member who does not request an extension within the first 90 days of CCC Plus enrollment or who develops ESRD while enrolled in CCC Plus will remain in CCC Plus.

9. Individuals who are institutionalized in certain state and private intermediate care facility for individuals with intellectual disabilities (ICF/IID) and mental health facilities as specified in the CCC Plus contract. "Intermediate care facility for individuals with intellectual disabilities" or "ICF/IID" means a facility licensed by the Department of Behavioral Health and Developmental Services in which care is provided to intellectually disabled individuals who are not in need of skilled nursing care, but who need more intensive training and supervision than would be available in a rooming home, boarding home, or group home. Such facilities must comply with Title XIX standards, provide health or rehabilitative services, and provide active treatment to members toward the achievement of a more independent level of functioning.

10. Individuals who are patients at nursing facilities operated by the Veterans Administration.

11. Individuals participating in the CMS Independence at Home (IAH) demonstration. However, IAH individuals may enroll in CCC Plus if they choose to disenroll from IAH.

12. Certain individuals in out-of-state placements as specified in the CCC Plus contract.

13. Individuals placed on spenddown. However, spenddown individuals are included if they are residing in a nursing home.

14. Incarcerated individuals. Individuals on house arrest are not considered incarcerated.

15. All children enrolled in the Virginia Birth-Related Neurological Injury Compensation Program, established pursuant to Chapter 50 of Title 38.2 (§ 38.2-5000 et seq.) of the Code of Virginia, who shall maintain enrollment in Medicaid fee-for-service.

16. Individuals who have any insurance purchased through the Health Insurance Premium Payment (HIPP) program, as defined in 12VAC30-20-205 and 12VAC30-20-210.

17. Individuals who are included in the Medicaid expansion population, but are not identified as medically complex. These individuals are covered through the Medallion program.

C. Enrollment in CCC Plus will be mandatory for eligible individuals. The department shall have sole authority and responsibility for the enrollment of individuals into the CCC Plus program and for excluding members from CCC Plus.

D. There shall be no retroactive enrollment for CCC Plus.

E. The MCO shall notify the member of enrollment in the MCO's plan through a letter submitted simultaneously with the handbook. Upon disenrollment from the plan, the MCO shall notify the member through a disenrollment notice that coverage in the MCO's plan will no longer be effective.

F. The department reserves the right to revise the CCC Plus intelligent default assignment methodology (as described in subsection I of this section) as needed based upon DMAS sole discretion.

G. Eligible individuals as defined in subsection A of this section shall be enrolled in a CCC Plus contracted health plan through a CCC Plus intelligent assignment methodology as defined by DMAS in the CCC Plus contract.

1. The member will be, at a minimum, notified of the 's member's assigned MCO, right to select another CCC Plus MCO operating in the 's member's locality, CCC Plus service begin date, and instructions for the individual or the individual's designee to contact DMAS or its enrollment broker to either:

a. Accept the assigned MCO; or

b. Select a different CCC Plus MCO that is operating in the individual's locality.

2. If an individual does not contact DMAS or its enrollment broker to accept the assigned MCO or select a different CCC Plus MCO operating in the individual's locality, the individual shall be enrolled into the assigned MCO.

3. For the initial 90 calendar days following the effective date of CCC Plus enrollment, the member will be permitted to disenroll from one MCO and enroll in another without cause. This 90-day timeframe applies only to the 's member's initial start date of enrollment in CCC Plus; it does not reset or apply to any subsequent enrollment periods. After the initial 90-day period following the initial enrollment date, the member may not disenroll without cause until the next annual open enrollment period.

4. Open enrollment is a period of time when individuals are able to change from one MCO to another without cause.

a. Open enrollment will occur at least once every 12 months per 42 CFR 438.56(c)(2) and 42 CFR 438.56(f)(1). The open enrollment will occur during October through December with any changes to take effect the following January 1. For individuals not participating in Medicaid expansion, open enrollment will occur from October 1 to December 18 for a January 1 effective date. Individuals participating through Medicaid expansion will have an open enrollment period from November 1 to December 18 for a January 1 effective date.

b. Within 60 days prior to the open enrollment effective date, the department will inform members of the opportunity to remain with the current plan or change to another plan without cause. Those individuals who do not choose a new MCO during the open enrollment period shall remain in their current MCO until their next open enrollment effective date.

H. DMAS shall utilize an intelligent default assignment process to assign eligible individuals, other than the ABD populations described in subdivision A 5 of this section, to a CCC Plus MCO contracted to operate in their locality. If none of the criteria used in the intelligent default assignment process applies to an individual, the individual will be randomly assigned to a CCC Plus MCO operating in the individual's locality. The intelligent default assignment process will, at a minimum, take into account:

1. The individual's previous Medicare and Medicaid MCO enrollment within the past two months if known at the time of assignment, the expansion member's child's Medicaid MCO enrollment; and

2. Which MCO the individual's current providers are contracted with. This may include the nursing facility an individual is residing in at the time of assignment, adult day health care for CCC Plus Waiver enrolled members, and an individual's private duty nursing provider.

I. Consistent with 42 CFR 438.56(d), DMAS must permit a member to disenroll at any time for cause.

1. A member may disenroll from the 's member's current plan for the following reasons:

a. The member moves out of the MCO's service area;

b. The MCO does not, because of moral or religious objections, cover the service the member seeks;

c. The member needs related services (e.g., a cesarean section and a tubal ligation) to be performed at the same time; not all related services are available within the provider network; and the 's member's primary care provider or another provider determines that receiving the services separately would subject the individual to unnecessary risk;

d. The member would have to change residential, institutional, or employment supports provider based on that provider's change in status from an in-network to an out-of-network provider with the MCO and, as a result, the member would experience a disruption in residence or employment; and

e. Other reasons as determined by DMAS, including poor quality of care, lack of access to services covered under this MCO, or lack of access to providers experienced in dealing with the 's member's care needs.

2. The 's member's request to change from one plan to another outside of open enrollment, or for cause request, may be submitted orally or in writing to the department as provided for in 42 CFR 438.56(d)(1) and cite the reasons why the member wishes to disenroll from one plan and enroll in another. The department will review the request in accordance with cause for disenrollment criteria defined in 42 CFR 438.56(d)(2). The department will respond to "for cause" requests, in writing, within 15 business days of the department's receipt of the request. In accordance with 42 CFR 438.56(e)(2), if the department fails to make a determination by the first day of the second month following the month in which the member files the request, the disenrollment request shall be considered approved and effective on the date of approval. Members who are dissatisfied with the department's determination of the 's member's request to disenroll from one plan and enroll in another for cause shall have the right to appeal through the state fair hearing process in 12VAC30-110.

J. CCC Plus eligible individuals who have been previously enrolled with a CCC Plus MCO and who regain eligibility for the CCC Plus program within 60 calendar days of the effective date of exclusion or disenrollment will be reassigned to the same MCO whenever possible and without going through the selection or assignment process.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-615 CCC Plus providers; Medicaid enrollment process

A. All individuals and entities who provide services of any type to CCC Plus members, including health care providers; pharmacies; ordering, referring, and prescribing providers; and providers who do not participate in Medicaid fee-for-service shall abide by all CCC Plus contract requirements regarding Provider Enrollment, pursuant to the 21st Century Cures Act (P.L. 114-255).

B. Each provider shall be screened and enrolled with DMAS through the DMAS provider enrollment system by December 1, 2019. The MCO shall ensure that all providers are registered in the DMAS provider enrollment system prior to contracting with the provider.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-620 MCO responsibilities; sanctions

A. The MCO and any of its subcontractors shall abide by all CCC Plus contract requirements, including:

1. The MCO shall provide medically necessary covered services in accordance with the CCC Plus contract.

a. Each MCO and its subcontractors shall have in place and follow written policies and procedures for processing requests for initial and continuing authorizations of service. Each MCO and its subcontractors shall ensure that any decision to deny a service authorization request or to authorize a service in an amount, duration, or scope that is less than requested be made by a health care professional who has appropriate clinical expertise in treating the member's condition or disease. Each MCO and its subcontractors shall have in effect mechanisms to ensure consistent application of review criteria for authorization decisions and shall consult with the requesting provider when appropriate.

b. In accordance with § 1932(f) of the Social Security Act (42 USC § 1396a-2), the contractor shall pay all in-network and out-of-network providers (including Native American health care providers) on a timely basis, consistent with the claims payment procedure described in 42 CFR 447.45 and 42 CFR 447.46 and § 1902(a)(37) of the Social Security Act, upon receipt of all clean claims, for covered services rendered to covered members who are enrolled with the contractor at the time the service was delivered. The MCO may deny claims in whole or in part for not meeting payment criteria established by the MCO.

c. Utilization review and audit. MCOs may perform utilization reviews and audits on their network providers. As a result of such a review or audit, an overpayment may be determined.

2. The MCO shall report data to DMAS per CCC Plus contract requirements, which includes data, claims reports, and quality studies performed by the MCO.

3. The MCO shall maintain records, including written policies and procedures, as required by the CCC Plus contract.

4. The MCO shall furnish such required information to DMAS, the Attorney General of Virginia or the Attorney General's authorized representative, or the State Medicaid Fraud Control Unit upon request and in the form requested.

5. The MCO shall meet standards specified in the CCC Plus contract for sufficiency of provider networks. In accordance with § 1915(b)(4) of the Social Security Act, 42 CFR 431.51, and 42 CFR 438.12b(1), the MCO does not have to contract with any willing provider.

6. The MCO shall conduct monthly checks to screen providers for exclusion.

7. The MCO shall require its providers and subcontractors to fully comply with federal requirements for disclosure of ownership and control, business transactions, and information for persons convicted of crimes against federal related health care programs, including Medicare, Medicaid, and CHIP programs, as described in 42 CFR 455 Subpart B.

8. In accordance with 42 CFR 447.50 through 42 CFR 447.60, the MCO shall not impose any cost sharing obligations on members except as set forth in 12VAC30-20-150 and 12VAC30-20-160 .

B. Sanctions shall be the same as those set forth in the CCC Plus contract.

C. As provided in 42 CFR 438.210(a)(5)(i), the MCO's medical necessity criteria shall not be more restrictive than the department's criteria.

D. The MCO's coverage rules for contract covered services shall also ensure compliance with federal EPSDT coverage requirements for members younger than 21 years of age.

E. The MCO shall provide services at least in equal amount, duration, and scope as available under the Medicaid fee-for-service program and as described in Attachment 5 of the CCC Plus contract.

F. The MCO shall not apply any financial requirement or treatment limitation to behavioral health benefits, including mental health or addiction, recovery and treatment benefits, in any classification (inpatient, out-patient, emergency, and pharmacy) that is more restrictive than the predominant financial requirement or treatment limitation of that type applied to substantially all medical/surgical benefits in the same classification furnished to members.

G. The MCO shall provide behavioral health benefits to the member in every classification in which medical/surgical benefits are provided.

H. The MCO shall not place any limitation on behavioral health benefits that is more restrictive than limits in place under fee-for-service Medicaid.

I. The MCO may cover, in addition to services covered under the state plan, any service necessary for compliance with the requirements for parity in mental health and substance abuse benefits in 42 CFR 438 Subpart K.

J. If a member of the MCO is provided behavioral health benefits in any classification of benefits (inpatient, outpatient, emergency care, or prescription drugs), the behavioral health benefits must be provided to the member in every classification in which medical/surgical benefits are provided.

K. The MCO shall not impose an aggregate lifetime dollar limit on any behavioral health benefit regardless of classification.

L. The MCO may not impose non-quantitative treatment limits (NQTL) for behavioral health benefits in any classification (inpatient, out-patient, emergency care, or prescription drugs) unless, under the policies and procedures of the MCO as written and in operation, any processes, strategies, evidentiary standards, or other factors used in applying the NQTL to behavioral health benefits in the classification are comparable to and are applied no more stringently than the processes, strategies, evidentiary standards, or other factors used in applying the limitation for medical/surgical benefits in the classification.

M. The MCO shall provide documentation necessary to establish and demonstrate compliance with mental health parity requirements in 42 CFR 438 Subpart K, regarding the provision of behavioral health benefits.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-625 Continuity of care

The MCO shall ensure continuity of care for each member upon enrollment into the member's plan. During the time period set forth in this section, the MCO shall maintain the member's current providers at the Medicaid FFS rate and honor service authorizations (SAs) issued prior to enrollment for the specified time period. The continuity of care period is as follows:

1. Within the first 30 calendar days of a member's enrollment, the MCO shall allow a member to maintain the member's current providers, including out-of-network providers. The MCO shall extend this timeframe as necessary to ensure continuity of care pending the provider contracting with the MCO or the member's safe and effective transition to a contracted provider. DMAS has sole discretion to extend the continuity of care period timeframe.

2. The MCO shall reimburse nursing facilities and specialized care services (described in 12VAC30-60-40, 12VAC30-60-320, and 12VAC30-60-340) no less than the Medicaid established per diem rate for Medicaid covered days, using the DMAS methodologies, unless the MCO and the provider mutually agree to an alternative payment methodology or value-based payment arrangement; however, the rate paid shall not be less than the current Medicaid fee-for-service rate.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-630 Covered services

A. The MCO shall, at a minimum, provide all medically necessary Medicaid covered services required under the state plan (12VAC30-50-10 through 12VAC30-50-310, 12VAC30-50-410 through 12VAC30-50-430, and 12VAC30-50-480 through 12VAC30-50-580); Elderly and Disabled with Consumer Direction waiver regulations (12VAC30-120-924 and 12VAC30-120-927); and community mental health services (12VAC30-50-130 and 12VAC30-50-226).

B. The following services are not covered by the MCO and shall be provided through fee-for-service outside the CCC Plus MCO contract:

1. Dental services (12VAC30-50-190);

2. School health services (12VAC30-50-130);

3. Preadmission screening (12VAC30-60-303); or

4. Community waiver services for individuals with developmental disabilities (12VAC30-122).

C. The Program of All-Inclusive Care for the Elderly, or PACE, is not available to CCC Plus members.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 14, eff. March 31, 2021; amended, Virginia Register Volume 41, Issue 19, eff. June 19, 2025.

12VAC30-120-635 Payment rates for MCOs

A. The payment rate to MCOs shall be set by negotiated contracts and in accordance with 42 CFR 438.6 Subpart A through 42 CFR 438.8 and other pertinent federal regulations.

B. In accordance with § 1932(b)(2)(D) of the Social Security Act and State Medicaid Director Letter 06-010, the contractor shall pay noncontracted providers for emergency services no more than the amount that would have been paid if the service had been provided under the state's FFS Medicaid program. The contractor shall reimburse out-of-network providers and providers of emergent or urgent care, as defined by 42 CFR 424.101 and 42 CFR 405.400 respectively, at the Medicaid FFS payment level for that service.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-640 State fair hearing process

A. Notwithstanding the provisions of 12VAC30-110-10 through 12VAC30-110-370, this section through 12VAC30-120-690 govern state fair hearings for individuals enrolled in CCC Plus.

B. The Appeals Division maintains an appeals and fair hearings system for members (referred to as "appellants" once the appeal process has begun) to challenge appeal decisions rendered by the MCO in response to member appeals of adverse benefit determinations related to Medicaid services. Exhaustion of the MCO's appeals process is a prerequisite to requesting a state fair hearing with the department. Appellants who meet the criteria for a state fair hearing shall be entitled to a state fair hearing before a department hearing officer.

C. The MCO shall conduct an internal appeal , pursuant to 42 CFR Part 431 Subpart E and 42 CFR Part 438 Subpart F, and issue a written decision that includes its findings and information regarding the appellant's right to file an appeal with DMAS for a state fair hearing for Medicaid appeals.

D. Members must be notified in writing of the MCO's internal appeals process in accordance with 42 CFR 438.400 et seq.:

1. With the handbook; and

2. Upon receipt of a notice of adverse benefit determination from the MCO.

E. Members must be notified in writing of their right to an external appeal to DMAS upon receipt of the MCO's final internal appeal decision.

F. An appellant shall have the right to representation by an attorney or an authorized representative at the internal appeal and external appeal before DMAS. An authorized representative may be designated to represent the appellant, pursuant to 12VAC30-110-60, 12VAC30-110-1380, and 12VAC30-110-1390, at the internal appeal and external appeal before DMAS.

G. Any communication from a member or the 's member's authorized representative that expresses the 's member's desire to present his case to a reviewing authority shall constitute an appeal request.

1. This communication should explain the basis for the appeal of the MCO's internal appeal decision.

2. The appellant or the appellant's authorized representative may examine witnesses, documents, or both; provide testimony; submit evidence; and advance relevant arguments during the state fair hearing.

H. After the MCO's internal appeal process has been exhausted, an appellant may request a state fair hearing by filing an appeal with the Appeals Division via regular mail, fax transmission, telephone, email, in person, or through other commonly available electronic means.

I. Expedited appeals referenced in subsection K of this section may be filed by telephone or any of the methods set forth in subsection H of this section.

J. The appellant member has the right to have his benefits continued during the MCO's appeal or the state fair hearing.

1. All of the following requirements must be met in order for benefits to be continued during the MCO and state fair hearing appeals:

a. The appeal involves the termination, suspension, or reduction of a previously authorized course of treatment;

b. The services were ordered by an authorized provider;

c. The original period covered by the initial authorization has not expired; and

d. The member requests that the benefits be continued.

2. For continuation of benefits for an internal appeal with the MCO, the member or authorized representative must file the appeal before the effective date of the adverse benefit determination or within 10 calendar days of the mail date of the MCO's notice of the adverse benefit determination.

3. For continuation of benefits for a state fair hearing, the member or authorized representative must file the appeal within 10 calendar days of the mail date of the MCO's final appeal decision.

4. The MCO shall also continue benefits for members who initiate a state fair hearing directly because of deemed exhaustion of appeals processes due to failure of the MCO to adhere to the notice and timing requirements in 42 CFR 438.408.

5. If the final resolution of the appeal or state fair hearing is adverse to the member, that is, upholds the MCO's adverse benefit determination, the MCO may recover the costs of services furnished to the member while the appeal and the state fair hearing was pending, to the extent they were furnished solely because of the pending appeal.

K. The MCO and the department shall maintain an expedited process for appeals when an appellant's treating provider indicates in making the request on the 's member's behalf or supporting the 's member's request that taking the time for a standard resolution could seriously jeopardize the 's member's life, physical or mental health, or ability to attain, maintain, or regain maximum function.

1. Resolution of an expedited appeal shall be no longer than 72 hours after the MCO receives the appeal.

2. Members must exhaust the MCO's internal appeals processes prior to filing an expedited appeal request with the department with the exception of those with members who gain direct access to state fair hearings because of deemed exhaustion of appeals processes with the MCO pursuant to 42 CFR 438.402(c)(1)(i)(A).

3. The MCO and the department may extend the timeframes for resolution of an expedited appeal by up to 14 calendar days if the member or the 's member's authorized representative requests the extension, or if the MCO or the department shows that there is a need for additional information and how the delay is in the 's member's best interest.

4. Requirements following extension. If the MCO extends the timeframes not at the request of the member, it shall complete the following:

a. Promptly notify the member of the reason for an extension and provide the date the extension expires; and

b. Resolve the appeal as expeditiously as the 's member's health condition requires and no later than the date the extension expires.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-650 Appeal timeframes

A. Appeals to the Medicaid state fair hearing process must be filed with the Appeals Division within 120 days of the date of the MCO's final internal appeal decision.

B. It is presumed that appellants will receive the MCO's final internal appeal decision five days after the MCO mails it unless the appellant shows that the appellant did not receive the notice within the five-day period.

C. A request for a state fair hearing on the grounds that the MCO has not acted with reasonable promptness in response to an internal appeal request may be filed at any time until the MCO has acted.

D. The date of filing shall be the date the internal appeal request is received by the MCO, the date the state fair hearing request is received by the Appeals Division, or the postmark date if the state fair hearing request is sent by regular mail.

E. In computing any time period under this chapter, the day of the act or event from which the designated period of time begins to run shall be excluded and the last day included. If a time limit would expire on a Saturday, Sunday, or state or federal holiday, it shall be extended until the next regular business day.

F. DMAS shall take final administrative action within 90 days from the date the member filed an MCO appeal, not including the number of days the member took to subsequently file for a state fair hearing.

G. Exceptions to standard appeal resolution timeframes. Decisions may be issued beyond the standard appeal resolution timeframes when the appellant or the appellant's authorized representative requests or causes a delay. Decisions may also be issued beyond the standard appeal resolution timeframe when any of the following circumstances exist:

1. The appellant or authorized representative requests to reschedule or continue the state fair hearing;

2. The appellant or authorized representative provides good cause for failing to keep a scheduled state fair hearing appointment, and the Appeals Division reschedules the state fair hearing;

3. Inclement weather, unanticipated system outage, or the department's closure prevents the hearing officer's ability to work;

4. Following a state fair hearing, the hearing officer orders an independent medical assessment as described in 12VAC30-120-670 H 1;

5. The hearing officer leaves the state fair hearing record open after the state fair hearing in order to receive additional evidence or argument from the appellant;

6. The hearing officer receives additional evidence from a person other than the appellant or the appellant's authorized representative, and the appellant requests to comment on such evidence in writing or to have the state fair hearing reconvened to respond to such evidence; or

7. The Appeals Division determines that there is a need for additional information and documents how the delay is in the appellant's best interest.

H. For delays requested or caused by an appellant or the appellant's authorized representative, the delay date for the decision will be calculated as follows:

1. If an appellant or authorized representative requests or causes a delay within 30 days of the request for a state fair hearing, the 90-day time limit will be extended by the number of days from the date when the first state fair hearing was scheduled until the date to which the state fair hearing is rescheduled.

2. If an appellant or authorized representative requests or causes a delay within 31 to 60 days of the request for a state fair hearing, the 90-day time limit will be extended by 1.5 times the number of days from the date when the first state fair hearing was scheduled until the date to which the state fair hearing is rescheduled.

3. If an appellant or authorized representative requests or causes a delay within 61 to 90 days of the request for a state fair hearing, the 90-day time limit will be extended by two times the number of days from the date when the first state fair hearing was scheduled until the date to which the state fair hearing is rescheduled.

I. Post state fair hearing delays requested or caused by an appellant or authorized representative (e.g., requests for the record to be left open) will result in a day-for-day delay for the decision date. The department shall provide the appellant and authorized representative with written notice of the reason for the decision delay and the delayed decision date, if applicable.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-660 Pre state fair hearing decisions

A. If the Appeals Division determines that any of the conditions as described in this subsection exist, a state fair hearing will not be held and the appeal process shall be terminated.

1. A request for appeal may be invalidated if:

a. It was not filed within the time limit imposed by 12VAC30-120-650; or

b. The individual who filed the appeal ("filer") is not the appellant or parent of a minor appellant, and the Appeals Division sends a letter to the filer requesting proof of the filer's authority to appeal on behalf of the appellant; and

(1) The filer did not reply within 10 calendar days to the request for authorization to represent the appellant ; or

(2) The filer replied within 10 calendar days of the request, and the Appeals Division determined that the authorization submitted was insufficient to allow the filer to represent the appellant under the provisions of 12VAC30-120-640.

2. A request for appeal may be administratively dismissed if:

a. The MCO's internal appeals process was not exhausted prior to the member's request for a state fair hearing;

b. The issue of the appeal is not related to the MCO's final internal appeal decision;

c. The adverse benefit determination being appealed was not taken by the MCO; or

d. The sole issue is a federal or state law requiring an automatic change adversely affecting some or all beneficiaries.

3. An appeal case may be closed if:

a. The Appeals Division schedules a state fair hearing and sends a written schedule letter notifying the appellant or the appellant's authorized representative of the date, time, and location of the state fair hearing; the appellant or the appellant's authorized representative fails to appear at the scheduled state fair hearing; and the Appeals Division sends a letter to the appellant for an explanation as to why he failed to appear; and

(1) The appellant did not reply within 10 calendar days to the request for an explanation that met good cause criteria ; or

(2) The appellant replied within 10 calendar days of the request, and the Appeals Division determined that the reply did not meet good cause criteria.

b. The Appeals Division sends a written schedule letter requesting that the appellant or the appellant's authorized representative provide a telephone number at which he can be reached for a telephonic state fair hearing, and the appellant or the appellant's authorized representative failed to respond within 10 calendar days to the request for a telephone number at which he could be reached for a telephonic state fair hearing.

c. The appellant or the appellant's authorized representative withdraws the appeal request. If the appeal request is withdrawn orally, the Appeals Division shall (i) record the individual's statement and telephonic signature and (ii) send the affected individual written confirmation via regular mail or electronic notification, in accordance with the individual's election.

d. The MCO approves the full amount, duration, and scope of services requested.

e. The evidence in the record shows that the MCO's decision was clearly in error and that the case should be fully resolved in the appellant's favor.

B. Remand to the MCO. If the hearing officer determines from the record, without conducting a state fair hearing, that the case might be resolved in the appellant's favor if the MCO obtains and develops additional information, documentation, or verification, the hearing officer may remand the case to the MCO for action consistent with the hearing officer's written instructions pursuant to 12VAC30-110-210 D.

C. A letter shall be sent to the appellant or the appellant's authorized representative that explains the determination made on the appeal.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-670 State fair hearing process and final decision

A. All state fair hearings shall be conducted de novo per 12VAC30-110-220. As such, no deference will be given to the entity that made the adverse action being appealed.

B. All state fair hearings must be scheduled at a reasonable time, date, and place, and the appellant and the appellant's authorized representative shall be notified in writing prior to the hearing.

1. The state fair hearing location will be determined by the Appeals Division.

2. A state fair hearing may be rescheduled at the appellant's request no more than twice unless compelling reasons exist, which shall be determined by the department hearing officer.

3. Rescheduling the state fair hearing at the appellant's request will result in automatic waiver of the 90-day deadline for resolution of the appeal. The delay date for the decision will be calculated as set forth in 12VAC30-120-650 H and I.

C. The state fair hearing shall be conducted by a department hearing officer. The hearing officer shall review the complete record for all MCO decisions that are properly appealed; conduct informal, fact-gathering state fair hearings; evaluate evidence presented; research the issues; and render a written final decision.

D. Subject to the requirements of all applicable federal and state laws regarding privacy, confidentiality, disclosure, and personally identifiable information, the appeal record shall be made accessible to the appellant and the appellant's authorized representative at a convenient place and time before the date of the state fair hearing, as well as during the state fair hearing. The appellant and the appellant's authorized representative may examine the content of the appellant's case file and all documents and records the department will rely on at the state fair hearing except those records excluded by law.

E. Appellants who require the attendance of witnesses or the production of records, memoranda, papers, and other documents at the state fair hearing may request in writing the issuance of a subpoena. The request must be received by the department at least 10 business days before the scheduled state fair hearing. Such request shall (i) include the witness's or respondent's name, home and work addresses, and county or city of work and residence and (ii) identify the sheriff's office that will serve the subpoena.

F. The hearing officer shall conduct the state fair hearing; decide on questions of evidence, procedure, and law; question witnesses; and assure that the state fair hearing remains relevant to the issue being appealed. The hearing officer shall control the conduct of the state fair hearing and decide who may participate in or observe the state fair hearing.

G. State fair hearings shall be conducted in an informal, impartial manner. The appellant and the appellant's authorized representative shall have the right to bring witnesses, establish all pertinent facts and circumstances, present an argument without undue interference, and question or refute the testimony or evidence, including the opportunity to confront and cross-examine agency representatives.

H. The rules of evidence shall not strictly apply. All relevant, nonrepetitive evidence may be admitted, but the probative weight of the evidence will be evaluated by the hearing officer.

I. The hearing officer may leave the state fair hearing record open for a specified period of time after the state fair hearing in order to receive additional evidence or argument from the appellant and the appellant's authorized representative.

1. At the appellant's option, the hearing officer may order an independent medical assessment when the appeal involves medical issues, such as a diagnosis, an examining physician's report, or a medical review team's decision, and the hearing officer determines that it is necessary to have an assessment by someone other than the person or team who made the original decision (e.g., to obtain more detailed medical findings about the impairments, to obtain technical or specialized medical information, or to resolve conflicts or differences in medical findings or assessments in the existing evidence). A medical assessment ordered pursuant to this chapter shall be at the department's expense, shall not extend any of the timeframes specified in this chapter, shall not disrupt the continuation of benefits, and shall become part of the record.

2. The hearing officer may receive evidence that was not presented by either party if the record indicates that such evidence exists, and the appellant or the appellant's authorized representative requests to submit it or requests that the hearing officer secure it.

3. If the hearing officer receives additional evidence from an entity other than the appellant or the appellant's authorized representative, the hearing officer shall send a copy of such evidence to the appellant and the appellant's authorized representative and give the appellant or the appellant's authorized representative the opportunity to comment on such evidence in writing or to have the state fair hearing reconvened to respond to such evidence.

4. Any additional evidence received will become a part of the state fair hearing record, but the hearing officer must determine whether or not it will be used in making the final decision.

J. After conducting the state fair hearing, reviewing the record, and deciding questions of law, the hearing officer shall issue a written final decision. The hearing officer's final decision shall be considered as the department's final administrative action pursuant to 42 CFR 431.244(f). The final decision shall include:

1. Identification of the issue;

2. Relevant facts, to include a description of the procedural development of the case;

3. Conclusions of law, regulations, and policy that relate to the issue;

4. Discussions, analysis of the accuracy of the MCO's appeal decision, conclusions, and hearing officer's decision;

5. Further action, if any, to be taken by the MCOs to implement the hearing officer's decision;

6. The deadline date by which further action must be taken; and

7. A cover letter informing the appellant and the appellant's authorized representative of the hearing officer's decision. The letter must indicate that the hearing officer's decision is final, and that the final decision may be appealed directly to circuit court.

K. A copy of the state fair hearing record shall be forwarded to the appellant and the appellant's authorized representative with the final decision.

L. An appellant who disagrees with the hearing officer's final decision described in this section may seek judicial review pursuant to the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) and Rules of the Supreme Court of Virginia, Part Two A. Written instructions for requesting judicial review must be provided to the appellant or the appellant's authorized representative with the hearing officer's decision, and upon request by the appellant or authorized representative.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 14, eff. March 31, 2021; amended, Virginia Register Volume 40, Issue 22, eff. August 1, 2024.

12VAC30-120-680 Appeals Division records

A. No person shall take from the department's custody any original record, paper, document, or exhibit that has been certified to the Appeals Division except as the Appeals Division Director or the director's designee authorizes, or as may be necessary to furnish or transmit copies for other official purposes.

B. Information in the appellant's record can be released only to the appellant, the appellant's authorized representative, the MCO, other entities for official purposes, and other persons named in a release of information authorization signed by an appellant or the appellant's authorized representative.

C. The fees to be charged and collected for any copy of Appeals Division records will be in accordance with Virginia's Freedom of Information Act (§ 2.2-3700 et seq. of the Code of Virginia) or other controlling law.

D. When copies are requested from records in the Appeals Division's custody, the required fee shall be waived if the copies are requested in connection with a member's own appeal.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-690 Provider appeals

A. The Appeals Division maintains an appeal process for network and Medicaid-enrolled providers of Medicaid services that have rendered services to members and are requesting to challenge an MCO's reconsideration decision regarding an adverse action affecting service authorization or payment. The MCO's internal reconsideration process is a prerequisite to filing for an external appeal to the department's provider appeal process. The appeal process is available to network and Medicaid-enrolled providers that (i) have rendered services and have been denied payment in whole or part for Medicaid covered services; (ii) have rendered services and have been denied authorization for the services; and (iii) have received a notice of program reimbursement or overpayment demand from the department or its contractors. Providers that have had their enrollment in the MCO's network denied or terminated by the MCO do not have the right to an external appeal with the Appeals Division.

B. Department provider appeals shall be conducted in accordance with the department's provider appeal regulations (12VAC30-20-500 et seq.), § 32.1-325 et seq. of the Code of Virginia, and the Virginia Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

C. The department's external appeal decision shall be binding upon the MCO and not subject to further appeal by the MCO.

D. If the provider is successful in its appeal of a reimbursement issue, then the MCO shall reimburse the provider for the appealed issue.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

Article 1 General Requirements [Repealed]

12VAC30-120-700 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 17, Issue 18, eff. July 1, 2001; amended, Virginia Register Volume 19, Issue 25, eff. October 1, 2003; Volume 23, Issue 20, eff. July 11, 2007; Volume 25, Issue 20, eff. July 9, 2009; Volume 30, Issue 14, April 10, 2014; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-710 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 17, Issue 18, eff. July 1, 2001; amended, Virginia Register Volume 19, Issue 25, eff. October 1, 2003; Volume 23, Issue 20, eff. July 11, 2007; Volume 25, Issue 20, eff. July 9, 2009; Volume 30, Issue 14, eff. April 10, 2014; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-720 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 17, Issue 18, eff. July 1, 2001; amended, Virginia Register Volume 19, Issue 25, eff. October 1, 2003; Volume 22, Issue 24, eff. September 6, 2006; Volume 23, Issue 20, eff. July 11, 2007; Volume 30, Issue 14, eff. April 10, 2014; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-730 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 17, Issue 18, eff. July 1, 2001; amended, Virginia Register Volume 23, Issue 20, eff. July 11, 2007; Volume 27, Issue 3, eff. November 10, 2010; Volume 30, Issue 14, eff. April 10, 2014; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-740 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 17, Issue 18, eff. July 1, 2001; amended, Virginia Register Volume 23, Issue 20, eff. July 11, 2007; Volume 30, Issue 14, eff. April 10, 2014; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

Article 2 Covered Services and Limitations and Related Provider Requirements

12VAC30-120-750 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 17, Issue 18, eff. July 1, 2001; amended, Virginia Register Volume 23, Issue 20, eff. July 11, 2007; Volume 30, Issue 14, eff. April 10, 2014; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-751 (Repealed.)

History

• Historical Notes: Previously reserved; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-752 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 17, Issue 18, eff. July 1, 2001; amended, Virginia Register Volume 23, Issue 20, eff. July 11, 2007; Volume 30, Issue 14, eff. April 10, 2014; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-753 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 23, Issue 20, eff. July 11, 2007; amended, Virginia Register Volume 30, Issue 14, eff. April 10, 2014; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-754 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 17, Issue 18, eff. July 1, 2001; amended, Virginia Register Volume 23, Issue 20, eff. July 11, 2007; Volume 25, Issue 20, eff. July 9, 2009; Volume 30, Issue 14, eff. April 10, 2014; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-755 (Repealed.)

History

• Historical Notes: Previously reserved; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-756 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 17, Issue 18, eff. July 1, 2001; amended, Virginia Register Volume 23, Issue 20, eff. July 11, 2007; Errata, 23:24 VA.R. 4080 August 6, 2007; amended, Virginia Register Volume 30, Issue 14, eff. April 10, 2014; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-757 (Repealed.)

History

• Historical Notes: Previously reserved; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-758 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 17, Issue 18, eff. July 1, 2001; amended, Virginia Register Volume 23, Issue 20, eff. July 11, 2007; Volume 25, Issue 20, eff. July 9, 2009; Volume 30, Issue 14, eff. April 10, 2014; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-759 (Repealed.)

History

• Historical Notes: Previously reserved; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-760 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 17, Issue 18, eff. July 1, 2001; amended, Virginia Register Volume 23, Issue 20, eff. July 11, 2007; Volume 30, Issue 7, eff. January 2, 2014; Volume 30, Issue 14, eff. April 10, 2014; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-761 (Repealed.)

History

• Historical Notes: Previously reserved; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-762 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 17, Issue 18, eff. July 1, 2001; amended, Virginia Register Volume 23, Issue 20, eff. July 11, 2007; Volume 25, Issue 20, eff. July 9, 2009; Volume 30, Issue 14, eff. April 10, 2014; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-763 (Repealed.)

History

• Historical Notes: Previously reserved; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-764 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 17, Issue 18, eff. July 1, 2001; amended, Virginia Register Volume 23, Issue 20, eff. July 11, 2007; Volume 30, Issue 14, eff. April 10, 2014; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-765 (Repealed.)

History

• Historical Notes: Previously reserved; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-766 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 17, Issue 18, eff. July 1, 2001; amended, Virginia Register Volume 23, Issue 20, eff. July 11, 2007; amended, Volume 27, Issue 19, eff. July 1, 2011; Volume 30, Issue 14, eff. April 10, 2014; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-767 (Repealed.)

History

• Historical Notes: Previously reserved; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-768 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 17, Issue 18, eff. July 1, 2001; repealed, Virginia Register Volume 23, Issue 20, eff. July 11, 2007.

12VAC30-120-769 (Repealed.)

History

• Historical Notes: Previously reserved; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-770 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 17, Issue 18, eff. July 1, 2001; Errata, 17:21 VA.R. 3124 July 2, 2001; amended, Virginia Register Volume 23, Issue 20, eff. July 11, 2007; Volume 25, Issue 20, eff. July 9, 2009; Volume 30, Issue 14, eff. April 10, 2014; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-771 (Repealed.)

History

• Historical Notes: Previously reserved; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-772 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 17, Issue 18, eff. July 1, 2001; amended, Virginia Register Volume 23, Issue 20, eff. July 11, 2007; Volume 30, Issue 14, eff. April 10, 2014; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-773 (Repealed.)

History

• Historical Notes: Previously reserved; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-774 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 17, Issue 18, eff. July 1, 2001; amended, Virginia Register Volume 23, Issue 20, eff. July 11, 2007; Volume 30, Issue 14, eff. April 10, 2014; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-775 (Repealed.)

History

• Historical Notes: Previously reserved; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-776 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 17, Issue 18, eff. July 1, 2001; Errata, 17:21 VA.R. 3124 July 2, 2001; amended, Virginia Register Volume 23, Issue 20, eff. July 11, 2007; Volume 30, Issue 14, eff. April 10, 2014; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-777 (Repealed.)

History

• Historical Notes: Previously reserved; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-780 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 17, Issue 18, eff. July 1, 2001; repealed, Virginia Register Volume 23, Issue 20, eff. July 11, 2007.

12VAC30-120-790 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 17, Issue 18, eff. July 1, 2001; repealed, Virginia Register Volume 23, Issue 20, eff. July 11, 2007.

Part IX Commonwealth Coordinated Care Plus Waiver

12VAC30-120-900 Definitions

The following words and terms when used in this part shall have the following meanings unless the context clearly indicates otherwise:

"Activities of daily living" or "ADLs" means personal care tasks such as bathing, dressing, toileting, transferring, and eating or feeding. An individual's degree of independence in performing these activities is a part of determining appropriate level of care and service needs.

"Adult" means an individual who is 21 years of age or older.

"Adult day health care" or "ADHC" means a program licensed by the Virginia Department of Social Services (VDSS) as an adult day care center (ADCC) and authorized as a Medicaid-enrolled provider meeting home and community-based services (HCBS) settings rules that provides a variety of health, therapeutic, and social services designed to meet the specialized needs of those waiver individuals who are elderly or who have a disability and who are at risk of placement in a nursing facility (NF). ADHC can also refer to the center where this service is provided.

"Adult protective services" or "APS" means the same as defined in § 63.2-100 of the Code of Virginia.

"Agency-directed model " means a model of service delivery where an agency is responsible for providing direct support staff, for maintaining individuals' records, and for scheduling the dates and times of the direct support staff's presence in the individuals' homes for personal and respite care.

"Agency provider" means a public or private organization or entity that holds a Medicaid provider agreement and furnishes services to individuals using its own employees or subcontractors.

"Annually" means a period of time covering 365 consecutive calendar days or 366 consecutive days in the case of leap years.

"Appeal" means the process used to challenge actions regarding services, benefits, and reimbursement provided by Medicaid pursuant to 12VAC30-110 and 12VAC30-20-500 through 12VAC30-20-570.

"Applicant" means an individual or representative on the individual's behalf who has applied for or is in the process of applying for and is awaiting a determination of eligibility for admission to the CCC Plus Program Waiver.

"Assess" means to evaluate an applicant's or an individual's condition, including functional status (i.e., an individual's degree of dependence in performing ADLs or IADLs), current medical status, psychosocial history, and environment. Information is collected from the applicant or individual, applicant's or individual's representative, family, and medical professionals as well as the assessor's observation of the applicant or individual.

"Assessment" means one or more processes that are used to obtain information about an individual, including the individual's condition, personal goals and preferences, functional limitations, health status, financial status, and other factors that are relevant to the determination of eligibility for service. An assessment is required for the authorization of and provision of services and for the development of the plan of care.

"Assistive technology" or "AT" means specialized medical equipment and supplies including those devices, controls, or appliances specified in the plan of care but not available under the State Plan for Medical Assistance that (i) enable individuals to increase their abilities to perform ADLs or IADLs and to perceive, control, or communicate with the environment in which the individuals live or (ii) are necessary to the proper functioning of the specialized equipment.

"Backup caregiver" means a secondary person who assumes the role of providing direct care to and support of the waiver individual in instances of emergencies and in the absence of the primary caregiver who is unable to care for the individual. The backup caregiver shall perform the duties needed by the waiver individual without compensation and shall be trained in the skilled needs and technologies required by the waiver individual. The backup caregiver shall be identified in the waiver individual's records.

"Backup plan" means a secondary network of supports to perform the duties needed by the waiver individual to ensure the individual's health, safety, and welfare should the paid caregiver be unable to provide such services. All waiver individuals are required to have a backup plan prior to initiation of services and ongoing, which shall be documented in the waiver individual's records. Those listed in the backup plan shall be trained in the skilled needs and technologies required by the waiver individual.

"Barrier crime" means those crimes as defined at § 19.2-392.02 of the Code of Virginia that would prohibit either the employment or the continuation of employment if a person is found, through a Virginia State Police criminal record check, to have been convicted of such a crime.

"Care coordinator" means a professional from one of the state's contracted managed care organizations who assists assigned individuals enrolled in the CCC Plus integrated care initiative using a team-based, person-centered approach to effectively manage an individual's medical, social, and behavioral conditions.

"CMS" means the Centers for Medicare and Medicaid Services, which is the unit of the U.S. Department of Health and Human Services that administers the Medicare and Medicaid programs.

"Child protective services" or "CPS" means the same as defined in § 63.2-100 of the Code of Virginia.

"Cognitive impairment" means a severe deficit in mental capability that affects a waiver individual's areas of functioning such as thought processes, problem solving, judgment, memory, or comprehension that interferes with such things as reality orientation, ability to care for self, ability to recognize danger to self or others, or impulse control.

"Commonwealth Coordinated Care Plus Program" or "CCC Plus" means the DMAS mandatory integrated care initiative for certain qualifying Medicaid members, including members who are dually eligible for Medicare and Medicaid and members receiving long-term services and supports (LTSS). The CCC Plus Program includes members who receive services through nursing facility (NF) care, specialized care NF, or long-stay hospitals, or from one of the four DMAS home and community-based services (HCBS) § 1915(c) waivers. Not all individuals in the CCC Plus Program will qualify for the CCC Plus Waiver.

"Community-based team" or "CBT" means the same as defined in 12VAC30-60-301.

"Congregate living arrangement" means a living arrangement in which three or fewer waiver individuals live in the same household and share receipt of health care services from the same provider.

"Congregate PDN" means skilled in-home nursing provided to three or fewer waiver individuals in the individuals' primary residence or a group setting.

"Consumer-directed attendant" means a person who provides, via the consumer-directed model of services, personal care or respite care, or any combination of these two services, and who is also exempt from workers' compensation.

"Consumer-directed" or "CD" means the model of service delivery for which the individual or the individual's employer of record, as appropriate, is responsible for hiring, training, supervising, and firing of the attendant or attendants who render the services that are reimbursed by DMAS.

"Critical incident" means any incident that threatens or impacts the well-being of a waiver individual. Critical incidents shall include the following incidents: medication errors, severe injury or fall, theft, suspected mental or physical abuse or neglect, financial exploitation, and death.

"Day" means, for the purposes of reimbursement, a 24-hour period beginning at 12 a.m. and ending at 11:59 p.m.

"DBHDS" means the Department of Behavioral Health and Developmental Services.

"Direct marketing" means any of the following: (i) conducting either directly or indirectly door-to-door, telephonic, or other "cold call" marketing of services at residences and provider sites; (ii) using direct mailing; (iii) paying "finders fees"; (iv) offering financial incentives, rewards, gifts, or special opportunities to eligible individuals, family, or caregivers as inducements to use a provider's services; (v) providing continuous, periodic marketing activities to the same prospective individual, family, or caregiver, for example, monthly, quarterly, or annual giveaways as inducements to use a provider's services; or (vi) engaging in marketing activities that offer potential customers rebates or discounts in conjunction with the use of a provider's services or other benefits as a means of influencing the individual's, family's, or caregiver's use of a provider's services.

"Direct medical benefit" means services or supplies that are proper and needed for the diagnosis or treatment of a medical condition; are provided for the diagnosis, direct care, and treatment of the condition; and meet the standards of professional medical practice.

"DMAS" means the Department of Medical Assistance Services.

"DMAS staff" means persons employed by the Department of Medical Assistance Services.

"Durable medical equipment and supplies" or "DME" means those items prescribed by the attending physician, generally recognized by the medical community as serving a diagnostic or therapeutic purpose to assist the waiver individual in the completion of everyday activities, and as being a medically necessary element of the service plan without regard to whether those items are covered by the State Plan for Medical Assistance.

"Early periodic screening, diagnosis, and treatment" or "EPSDT" means the benefit program administered by DMAS for individuals younger than 21 years of age in accordance with the definition set forth at 42 CFR 440.40 (b) and the requirements of 42 CFR 441, Subpart B.

"Employer of record" or "EOR" means the person who performs the functions of the employer in the consumer-directed model of service delivery. The EOR may be the individual, a family member, caregiver, or another person.

"Enrollment" means the process where an individual has been determined to meet the financial and categorical eligibility requirements for a Medicaid program or service, and the approving entity has verified the availability of services for the individual requesting waiver enrollment and services.

"Environmental modifications" or "EM" means physical adaptations to an individual's primary residence or primary vehicle that are necessary to ensure the individual's health, safety, and welfare or that enable the individual to function with greater independence and shall be of direct medical or remedial benefit to the individual. Such physical adaptations shall not be authorized for Medicaid payment when the adaptation is being used to bring a substandard dwelling up to minimum habitation standards.

"Fiscal/employer agent" or "F/EA" means a state agency or other entity as determined by DMAS that meets the requirements of 42 CFR 441.484 and the Virginia Public Procurement Act, § 2.2-4300 et seq. of the Code of Virginia.

"Guardian" means a person appointed by a court to manage the personal affairs of an incapacitated individual pursuant to Chapter 20 (§ 64.2-2000 et seq.) of Title 64.2 of the Code of Virginia.

"Health, safety, and welfare" means, for the purposes of this waiver, that an individual's right to receive a CCC Plus Waiver service is dependent on a determination that the waiver individual needs the service based on appropriate assessment criteria and a written plan of care, including having a backup plan of care, that demonstrates medical necessity and that services can be safely provided in the community or through the model of care selected by the individual.

"Home and community-based waiver services" or "waiver services" means the range of community support services approved by the CMS pursuant to § 1915(c) of the Social Security Act to be offered to individuals as an alternative to institutionalization.

"Institution" means a nursing facility, specialized care nursing facility, or long-stay hospital. Individuals who receive enrollment in the CCC Plus Waiver are deemed to meet the level of care necessary for residence in one of these institutions or are anticipated to need to be in one of these institutions within the next 30 days without the services of the waiver.

"Instrumental activities of daily living" or "IADLs" means tasks such as meal preparation, shopping, housekeeping, and laundry. An individual's degree of independence in performing these activities is a part of determining appropriate service needs.

"Level of care" or "LOC" means the specification of the minimum amount of assistance an individual requires in order to receive services in an institutional setting under the State Plan or to receive waiver services.

"License" means proof of official or legal permission issued by the government for an entity or person to perform an activity or service.

"Licensed Practical Nurse" or "LPN" means a person who is licensed or holds multi-state licensure to practice nursing pursuant to Chapter 30 (§ 54.1-3000 et seq.) of Title 54.1 of the Code of Virginia.

"Local department of social services" or "LDSS" means the entity established under § 63.2-324 of the Code of Virginia by the governing city or county in the Commonwealth.

"Long-term services and supports" or "LTSS" means a variety of services that help individuals with health or personal care needs and activities of daily living over a period of time. Long-term care can be provided in the home, in the community, or in various types of facilities, including nursing facilities and assisted living facilities.

"LTSS screening" means the process to (i) evaluate the functional, nursing, and social supports of individuals referred for screening for certain long-term care services and supports requiring nursing facility eligibility; (ii) assist individuals in determining what specific services the individual needs; (iii) evaluate whether a service or a combination of existing community services are available to meet an individual's needs; and (iv) provide a list to individuals of appropriate providers for Medicaid-funded nursing facility or home and community-based care for those individuals who meet nursing facility level of care.

"LTSS screening team" means the entity contracted with DMAS that is responsible for performing the screening process pursuant to § 32.1-330 of the Code of Virginia.

"Managed care organization" or "MCO" means the same as the definition of this term in 42 CFR 438.2 .

"Medicaid Long-Term Services and Supports Communication Form" or "DMAS-225" means the form used by the long-term care provider to report information about changes in an individual's eligibility and financial circumstances.

"Medically necessary" means those services or specialized medical equipment or supplies that are covered for reimbursement under either the State Plan for Medical Assistance or in a waiver program that are reasonable, proper, and necessary for the treatment of an illness, injury, or deficit; are provided for direct care of the condition or to maintain or improve the functioning of a malformed body part; and meet the standards of good professional medical practice as determined by DMAS.

"Medication monitoring" means an electronic device, which is only available in conjunction with personal emergency response systems, that reminds an individual to take medications at the correct dosages and times.

"Minor child" means an individual who is younger than 18 years of age.

"Monitoring" means the ongoing oversight of the provision of waiver and other services to determine that they are furnished according to the waiver individual's plan of care and effectively meet the individual's needs, thereby ensuring the individual's health, safety, and welfare. Monitoring activities may include telephone contact; observation; interviewing the individual or the trained individual representative, as appropriate, in person or by telephone; or interviewing service providers.

"Nurse supervisor" means a registered nurse (RN) or licensed professional nurse (LPN) hired or contracted by an agency to provide the supervisory responsibilities as outlined in the waiver to the agency's staff who perform personal care or respite care services to waiver individuals.

"Participating provider" or "provider" means an entity that meets the standards and requirements set forth by DMAS and has a current, signed provider participation agreement with DMAS or a managed care organization that has a signed contract with DMAS.

"Patient pay amount" means the portion of the individual's income that must be paid as the individual's share of the long-term services and supports and is calculated by the local department of social services based on the individual's documented monthly income and permitted deductions.

"Person-centered planning" means a fundamental process that focuses on what is important to and for an individual and the needs and preferences of the individual to create a plan of care.

"Personal care aide" or "aide" means a person employed by an agency who provides personal care or unskilled respite services. The aide shall have successfully completed an educational curriculum of at least 40 hours of study related to the needs of individuals who are either elderly or who have disabilities as further set out in 12VAC30-120-935. Such successful completion may be evidenced by the existence of a certificate of completion issued by the training entity, which is provided to DMAS during provider audits.

"Personal care attendant," "attendant," or "PCA" means a person who provides personal care or respite services that are directed by an employer of record under the CD model of service delivery.

"Personal care services" or "PC services" means a range of support services that includes assistance with ADLs or IADLs, access to the community, self-administration of medication or other medical needs, and the monitoring of health status and physical condition provided through the agency-directed or consumer-directed model of service. Personal care services shall be provided by aides or attendants within the scope of their licenses or certifications, as appropriate.

"Personal emergency response system" or "PERS" means an electronic device and monitoring service that enables certain waiver individuals who are at least 14 years of age and at risk of institutionalization to secure help in an emergency.

"PERS provider" means a certified home health or a personal care agency, a durable medical equipment provider, a hospital, or a PERS manufacturer that has the responsibility to furnish, install, maintain, test, monitor, and service PERS equipment, direct services (i.e., installation, equipment maintenance, and services calls), and PERS monitoring. PERS providers may also provide medication monitoring.

"Plan of care" or "POC" means the written plan developed collaboratively by the waiver individual and the waiver individual's family or caregiver, as appropriate, and the provider related solely to the specific services necessary for the individual to remain in the community while ensuring the individual's health, safety, and welfare.

"Private duty nursing services" or "PDN" means skilled in-home nursing services listed in the POC that are (i) not otherwise covered under the State Plan for Medical Assistance home health benefit; (ii) required to prevent institutionalization; or (iii) provided within the scope of the Commonwealth's Nurse Practice Act (Chapter 30 (§ 54.1-3000 et seq.) of Title 54.1 of the Code of Virginia) and Drug Control Act ( Chapter 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia).

"Provider agreement" means the contract between DMAS and a participating provider under which the provider agrees to furnish services to Medicaid-eligible individuals in compliance with state and federal statutes and regulations and Medicaid contract requirements.

"Registered nurse" or "RN" means a person who is licensed or who holds multi-state licensure privilege pursuant to Chapter 30 (§ 54.1-3000 et seq.) of Title 54.1 of the Code of Virginia to practice nursing.

"Respite services" means services provided to waiver individuals that are furnished on a short-term basis because of the absence of or need for the relief of the unpaid primary caregiver who normally provides the care.

"Service authorization" means the process of approving a service for the individual. The process of approving is done by DMAS, its service authorization contractor, or an MCO.

"Service authorization contractor" means DMAS or the entity that has been contracted by DMAS, including an MCO, to perform service authorization for medically necessary Medicaid covered home and community-based services.

"Services facilitation" means a service that assists the waiver individual (or family, caregiver, or EOR, as appropriate) in arranging for, directing, training, and managing services provided through the consumer-directed model of service.

"Skilled private duty nursing services" or "skilled PDN" means skilled in-home nursing services listed in the POC that are (i) not otherwise covered under the State Plan for Medical Assistance home health benefit; (ii) required to prevent institutionalization; and (iii) provided within the scope of the Commonwealth's Nurse Practice Act (Chapter 30 (§ 54.1-3000 et seq.) of Title 54.1 of the Code of Virginia) and Drug Control Act (Chapter 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia).

"Skilled respite services" means temporary skilled nursing services that are provided to waiver individuals and that are performed by an LPN or RN for the relief of the unpaid primary caregiver who normally provides the care.

"State Plan for Medical Assistance" or "State Plan" means the Commonwealth's legal document approved by CMS identifying the covered groups, covered services and their limitations, and provider reimbursement methodologies as provided for under Title XIX of the Social Security Act.

"Transition services" means set-up expenses for individuals as defined at 12VAC30-120-2010.

"Unpaid primary caregiver" means the primary person who consistently assumes the primary role of providing direct care and support of the waiver individual to live successfully in the community without receiving compensation for providing such care.

"VDH" means the Virginia Department of Health.

"VDSS" means the Virginia Department of Social Services.

"Virginia Uniform Assessment Instrument" or "UAI" means the standardized multidimensional assessment that is completed by the screening entity that assesses an individual's physical health, mental health, and psychosocial and functional abilities to determine if the individual meets the nursing facility level of care.

"Waiver individual" or "individual" means the person who has applied for and been approved to receive these waiver services.

"Weekly" means a span of time covering seven consecutive calendar days.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 10, eff. February 22, 2006; amended, Virginia Register Volume 25, Issue 20, eff. July 9, 2009; Volume 31, Issue 10, eff. February 12, 2015; Volume 40, Issue 20, eff. June 19, 2024.

12VAC30-120-905 Waiver description and legal authority

A. The Commonwealth Coordinated Care Plus (CCC Plus) Waiver operates under the authority of § 1915(c) of the Social Security Act and 42 CFR 430.25(b), which permit the waiver of certain State Plan requirements. These federal statutory and regulatory provisions permit the establishment of Medicaid waivers to afford the states with greater flexibility to devise different approaches to the provision of long-term services and supports. Under this § 1915(c) waiver, DMAS waives § 1902(a)(10)(B) and (C) of the Social Security Act related to comparability of services.

B. CCC Plus Waiver services shall be covered only for Medicaid-eligible individuals who have been determined eligible to require the level of care provided in either a nursing facility, specialized care nursing facility, or long-stay hospital. These services shall be the critical service necessary to delay or avoid the individual's placement in an appropriate facility.

C. Federal waiver requirements provide that the current aggregate average cost of care fiscal year expenditures under this waiver shall not exceed the average per capita expenditures in the aggregate for the level of care (LOC) provided in a nursing facility (NF), specialized care nursing facility, or long-stay hospital under the State Plan that would have been provided had the waiver not been granted.

D. DMAS shall be the single state agency authority, pursuant to 42 CFR 431.10, responsible for the processing and payment of claims for the services covered in this waiver and for obtaining federal financial participation from CMS.

E. Payments for CCC Plus Waiver services shall not be provided to any financial institution or entity located outside of the United States pursuant to § 1902(a)(80) of the Social Security Act. Payments for CCC Plus Waiver services furnished in another state shall be (i) provided for an individual who meets the requirements of 42 CFR 431.52 and (ii) limited to the same service limitations that exist when services are rendered within the Commonwealth's political boundaries. Waiver services shall not be covered for Medicaid-eligible individuals who are inpatients of a hospital, nursing facility (NF), intermediate care facility for individuals with intellectual disabilities (ICF/IID), rehabilitation hospitals, assisted living facility licensed by VDSS that serves five or more persons, long-stay hospitals, specialized care nursing facilities, adult foster homes, or group homes licensed by DBHDS.

F. An individual shall not be simultaneously enrolled in more than one waiver program but may be listed on the waiting list for another waiver program as long as criteria are met for both waiver programs.

G. DMAS shall be responsible for the following:

1. Placing individuals in appropriate services that are home and community based;

2. Providing reimbursement for waiver services only after the provider is enrolled and the individual's eligibility process is complete;

3. Not duplicating services that are required as a reasonable accommodation as a part of the Americans with Disabilities Act (42 USC §§ 12131 through 12165) or the Rehabilitation Act of 1973 (29 USC § 794). CCC Plus Waiver services shall not be authorized if another entity is required to provide the services (e.g., schools, insurance) because these waiver services shall not duplicate payment for services available through other programs or funding streams; and

4. Ensuring providers meet the following requirements:

a. Providers shall consider DMAS payment for services under this waiver as payment in full and no balance billing from the provider to the individual, any family member, caregiver, or the employer of record (EOR) of the waiver individual shall be permitted; and

b. Additional voluntary payments or gifts from family members shall not be accepted by providers of services.

H. DMAS or the designated service authorization contractor or managed care organization shall have the responsibility and the authority to terminate the receipt of home and community-based waiver enrollment for the waiver individual for any of the following reasons. Individuals shall be notified of their appeal rights pursuant to 12VAC30-110:

1. The home and community-based waiver services are no longer the critical alternative to prevent or delay institutional placement within 30 days;

2. The waiver individual is no longer eligible for Medicaid;

3. The waiver individual no longer meets the LOC criteria required for the waiver;

4. The waiver individual's environment in the community does not provide for the individual's health, safety, or welfare;

5. The waiver individual does not have a backup plan for services in the event the provider is unable to provide services; or

6. Any other circumstances that cause services to cease or be interrupted for more than 30 consecutive calendar days.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 31, Issue 10, eff. February 12, 2015; amended, Virginia Register Volume 40, Issue 20, eff. June 19, 2024.

12VAC30-120-910 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 22, Issue 10, eff. February 22, 2006; amended, Virginia Register Volume 25, Issue 19, eff. July 1, 2009; Volume 25, Issue 20, eff. July 9, 2009; repealed, Virginia Register Volume 31, Issue 10, eff. February 12, 2015.

12VAC30-120-920 Individual eligibility requirements

A. Home and community-based waiver services shall be available through a § 1915(c) waiver of the Social Security Act for the following Medicaid-eligible individuals who have been determined to be eligible for waiver services and to require the level of care provided in a nursing facility (NF), long-stay hospital, or specialized care nursing facility:

1. Individuals who are elderly as defined by § 1614 of the Social Security Act; or

2. Individuals who have a disability as defined by § 1614 of the Social Security Act.

B. The Commonwealth has elected to cover low-income families with children as described in § 1931 of the Social Security Act; aged, blind, or disabled individuals who are eligible under 42 CFR 435.121; optional categorically needy individuals who are aged and disabled who have incomes at 80% of the federal poverty level; the special home and community-based waiver group under 42 CFR 435.217; and the medically needy groups specified in 42 CFR 435.320, 435.322, 435.324, and 435.330.

1. Under this waiver, the coverage groups authorized under § 1902(a)(10)(A)(ii)(VI) of the Social Security Act shall be considered as if the individual were institutionalized in an NF, specialized care NF, or long-stay hospital for the purpose of applying institutional deeming rules. All individuals in the waiver must meet the financial and nonfinancial Medicaid eligibility criteria and meet the institutional level of care (LOC) criteria. The deeming rules are applied to waiver eligible individuals as if the individual were residing in an institution or would require that level of care.

2. Virginia shall reduce its payment for home and community-based services provided to an individual who is eligible for Medicaid services under 42 CFR 435.217 by the amount of the waiver individual's total income (including amounts disregarded in determining financial eligibility) that remains after allowable deductions for personal maintenance needs, deductions for other dependents, and medical needs have been made, according to the guidelines in 42 CFR 435.735 and § 1915(c)(3) of the Social Security Act as amended by the Consolidated Omnibus Budget Reconciliation Act of 1986. DMAS shall reduce its payment for home and community-based waiver services by the amount that remains after the following deductions:

a. For waiver individuals to whom § 1924(d) applies (Virginia waives the requirement for comparability pursuant to § 1902(a)(10)(B)), deduct the following in the respective order:

(1) An amount for the maintenance needs of the waiver individual that is equal to 165% of the SSI income limit for one individual. Working individuals have a greater need due to expenses of employment; therefore, an additional amount of income shall be deducted. Earned income shall be deducted within the following limits: (i) for waiver individuals employed 20 hours or more per week, earned income shall be disregarded up to a maximum of both earned and unearned income up to 300% of SSI and (ii) for waiver individuals employed at least four but less than 20 hours per week, earned income shall be disregarded up to a maximum of both earned and unearned income up to 200% of SSI. However, in no case shall the total amount of income (both earned and unearned) that is disregarded for maintenance exceed 300% of SSI. If the waiver individual requires a guardian or conservator who charges a fee, the fee, not to exceed an amount greater than 5.0% of the waiver individual's total monthly income, is added to the maintenance needs allowance. However, in no case shall the total amount of the maintenance needs allowance (basic allowance plus earned income allowance plus guardianship fees) for the individual exceed 300% of SSI;

(2) For a waiver individual with only a spouse at home, the community spousal income allowance is determined in accordance with § 1924(d) of the Social Security Act;

(3) For an individual with a family at home, an additional amount for the maintenance needs of the family is determined in accordance with § 1924(d) of the Social Security Act; and

(4) Amounts for incurred expenses for medical or remedial care that are not subject to payment by a third party, including Medicare and other health insurance premiums, deductibles, or coinsurance charges and necessary medical or remedial care recognized under the state law but not covered under the State Plan.

b. For waiver individuals to whom § 1924(d) of the Social Security Act does not apply, deduct the following in the respective order:

(1) An amount for the maintenance needs of the waiver individual that is equal to 165% of the SSI income limit for one individual. Working individuals have a greater need due to expenses of employment; therefore, an additional amount of income shall be deducted. Earned income shall be deducted within the following limits: (i) for waiver individuals employed 20 hours or more, earned income shall be disregarded up to a maximum of 300% of SSI and (ii) for waiver individuals employed at least four but less than 20 hours, earned income shall be disregarded up to a maximum of 200% of SSI. However, in no case shall the total amount of income (both earned and unearned) that is disregarded for maintenance exceed 300% of SSI. If the individual requires a guardian or conservator who charges a fee, the fee, not to exceed an amount greater than 5.0% of the individual's total monthly income, is added to the maintenance needs allowance. However, in no case shall the total amount of the maintenance needs allowance (basic allowance plus earned income allowance plus guardianship fees) for the individual exceed 300% of SSI;

(2) For an individual with a family at home, an additional amount for the maintenance needs of the family that shall be equal to the medically needy income standard for a family of the same size; and

(3) Amounts for incurred expenses for medical or remedial care that are not subject to payment by a third party including Medicare and other health insurance premiums, deductibles, or coinsurance charges and necessary medical or remedial care recognized under state law but not covered under the State Plan.

C. Assessment and authorization of home and community-based waiver services.

1. To ensure that Virginia's home and community-based waiver programs serve only Medicaid eligible individuals who would otherwise be supported in an NF, specialized care NF, or long-stay hospital, home and community-based waiver services shall be considered only for individuals who are eligible for admission within 30 calendar days to one of these institutions. Home and community-based waiver services shall be the critical service to enable the individual to remain at home and in the community rather than being placed in an institution.

2. The individual's eligibility for home and community-based waiver services shall be determined by the LTSS screening team after completion of a thorough assessment of the individual's needs and available support. If the individual is determined eligible based on the procedures outlined in 12VAC30-60-303, the LTSS screening team shall provide the individual and family or caregiver with the choice of CCC Plus Waiver services, other appropriate services, institutional placement, or Program of All Inclusive Care for the Elderly (PACE) enrollment for people 55 years of age or older.

3. The LTSS screening team shall explore alternative settings or services to provide the care needed by the individual. If Medicaid-funded home and community-based waiver services are selected by the individual, the LTSS screening team shall initiate referrals for such services.

4. Medicaid shall not pay for any home and community-based waiver services delivered prior to the date the individual establishes Medicaid financial eligibility and the date of the LTSS screening with the physician's signature on the Medicaid Funded Long-Term Care Services Authorization Form (DMAS-96).

5. Before Medicaid shall assume payment responsibility of home and community-based services, service authorization must be obtained from DMAS or the DMAS-designated service authorization contractor for all services requiring service authorization. Providers shall submit all required information to DMAS or the designated service authorization contractor within 10 business days of initiating care or within 10 business days of receiving verification of Medicaid financial eligibility from the local department of social services. If the provider submits all required information to DMAS or the designated service authorization contractor within 10 business days of initiating care, services may be authorized beginning from the date the provider initiated services but not preceding the date of the physician's signature on the DMAS-96 form. If the provider does not submit all required information to DMAS or the designated service authorization contractor within 10 business days of initiating care, the services may be authorized beginning with the date all required information was received by DMAS or the designated service authorization contractor, but in no event preceding the date of the physician's signature on the DMAS-96 form.

6. Once waiver eligibility has been determined by the LTSS screening team and referrals have been initiated, the provider or MCO shall submit a Medicaid LTSS Communication Form (DMAS-225) to the local department of social services to determine financial eligibility for the waiver program and any patient pay responsibilities. If the waiver individual has a patient pay amount, a provider shall use the electronic patient pay process for the required monthly monitoring of relevant changes. Local departments of social services shall enter data regarding a waiver individual's patient pay amount obligation into the DMAS system of record at the time action is taken on behalf of the individual either as a result of an application for LTSS, redetermination of financial eligibility, or reported change or changes in a waiver individual's situation. Procedures for the verification of a waiver individual's patient pay obligation are available in the appropriate Medicaid provider manual.

7. After the provider or MCO has received notification via the DMAS-225 process by the local department of social services and enrollment confirmation from DMAS or the designated service authorization contractor, the provider shall inform the individual, family, or caregiver so that services may be initiated.

8. The provider or MCO shall be responsible for notifying the local department of social services via the DMAS-225 when there is an interruption of services for 30 consecutive calendar days or upon discharge or transfer from the provider's services.

9. Certain home and community-based services shall not be available to individuals residing in an assisted living facility licensed by VDSS that serves four or fewer individuals. These services are: respite, PERS, ADHC, environmental modifications, and transition services. Personal care services shall be covered for individuals living in these facilities but shall not exceed five hours per day. Personal care services shall be authorized based on the waiver individual's documented need for care over and above that which is provided by the assisted living facility.

10. Individuals who are receiving Auxiliary Grants shall not be eligible for CCC Plus Waiver enrollment or services.

11. All individuals shall have a backup plan prior to initiating services and ongoing in cases of emergency or should the provider be unable to render services as needed. This backup plan shall be shared with the provider at the onset of services and updated with the provider as necessary.

12. Individuals who are receiving PDN waiver services shall have a trained primary caregiver who accepts responsibility for the individual's health, safety, and welfare. This primary caregiver shall be responsible for all hours not provided by an RN or an LPN. The name of the trained primary caregiver shall be documented in the provider's records.

D. Waiver individual responsibilities under the consumer-directed (CD) model.

1. The individual shall be authorized for CD services and the employer of record (EOR) shall successfully complete consumer employee management training performed by the services facilitator before the waiver individual or EOR shall be permitted to hire a personal care attendant for Medicaid reimbursement. Any services rendered by an attendant prior to dates authorized by Medicaid shall not be eligible for reimbursement. Individuals who are eligible for CD services shall have the capability to hire and train their own personal care attendants and supervise the attendants' performance including creating and maintaining complete and accurate work shift entries. The EOR may be the individual or a family member, caregiver, or another person designated by the individual to serve on the individual's behalf.

2. The person who serves as the EOR shall not be permitted to be (i) the paid attendant for respite services or personal care services or (ii) the services facilitator.

3. Individuals shall not knowingly continue to accept CD personal care services when the service is no longer appropriate or necessary for their care needs and shall inform the services facilitator. If CD services continue after services have been terminated by DMAS or the designated service authorization contractor, the waiver individual shall be held liable for attendant compensation.

4. The individual or EOR, as appropriate, shall notify the services facilitator of all hospitalizations and admission to any rehabilitation hospital unit, NF, specialized care NF, or long-stay hospital as soon as possible. Failure to do so may result in the waiver individual being liable for employee compensation.

E. Waiver individuals' rights and responsibilities. DMAS shall ensure that:

1. Each waiver individual shall receive, and the provider shall provide, the necessary care and services, to the extent of provider availability, to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the person-centered planning of the individual's comprehensive assessment and plan of care (POC).

2. Waiver individuals shall have the right to participate in the development of the plan of care and to receive services from the provider with reasonable accommodation of the individual's needs and preferences except when DMAS makes a determination that the health, safety, or welfare of the waiver individual or other individuals would be endangered.

3. All waiver individuals shall have the right to:

a. Voice grievances to the provider or provider staff without discrimination or reprisal. Such grievances include those with respect to treatment that has or has not been furnished;

b. Prompt efforts by the provider or staff, as appropriate, to resolve any grievances the waiver individual may have;

c. Be free from verbal, sexual, physical, and mental abuse, neglect, exploitation, and misappropriation of property;

d. Be treated with respect and with due consideration for the individual's dignity and privacy;

e. Be free from any physical or chemical restraints or seclusion of any form that may be used as a means of coercion, discipline, convenience, or retaliation and that are not required to treat the individual's medical symptoms;

f. The privacy and confidentiality of the individual's medical and clinical records; and

g. Receive information, such as a handbook or provider directory, in a manner and format that may be easily understood (i.e., in prevalent non-English languages and using translation services) and that is readily accessible in accordance with the standards specified in 42 CFR 438.10.

4. The waiver individual if legally competent, the waiver individual's legal guardian, or the parent of the minor child shall have the right to:

a. Choose whether the individual wishes to receive home and community-based care waiver services instead of institutionalization in accordance with the assessed needs of the individual. The LTSS screening team or MCO shall inform the individual of all available waiver service providers in the community in which the waiver individual resides. The waiver individual shall have the option of selecting the provider and services of the individual's choice. Individuals enrolled in the CCC Plus Program shall have the option of selecting a provider in the MCO's contracted network and services of the individual's choice. This choice must be documented in the individual's medical record;

b. Choose a primary care physician in the community in which the individual resides;

c. Be fully informed in advance about the waiver POC and treatment needs as well as any changes in that care or treatment that may affect the individual's well-being;

d. Participate in the care planning process, choice, and scheduling of providers and services; and

e. Be provided care with privacy, dignity, and respect at all times.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 10, eff. February 22, 2006; amended, Virginia Register Volume 22, Issue 24, eff. September 6, 2006; Volume 25, Issue 20, eff. July 9, 2009; Volume 31, Issue 10, eff. February 12, 2015; Volume 40, Issue 20, eff. June 19, 2024.

12VAC30-120-924 Covered services; limits on covered services

A. Covered services in the CCC Plus Waiver are as follows: adult day health care; personal care (both consumer-directed and agency-directed); respite services (both consumer-directed and agency-directed); PERS services, including medication monitoring; services facilitation; private duty nursing; assistive technology; environmental modifications; and transition services.

1. The services covered in this waiver shall be appropriate and medically necessary to maintain the individual in the community in order to prevent institutionalization and shall be cost effective in the aggregate as compared to the alternative institutional placement.

2. CCC Plus Waiver services shall not be authorized if another entity is required to provide the services (e.g., schools, insurance). Waiver services shall not duplicate services available through other programs or funding streams.

3. An individual receiving CCC Plus Waiver services who is also getting hospice care may receive Medicaid-covered personal care (agency-directed and consumer-directed), respite care (agency-directed and consumer-directed), services facilitation, private duty nursing, adult day health care, transition services, and PERS services, regardless of whether the hospice provider receives reimbursement from Medicare or Medicaid for the services covered under the hospice benefit.

4. Agency-directed and consumer-directed personal care services and respite care services shall be subject to the electronic visit verification requirements set out in 12VAC30-60-65.

B. Disenrollment from consumer-directed services. In disenrollment situations, the waiver individual shall be offered agency-directed personal care and respite services from a provider of the waiver individual's choice.

1. A waiver individual may be found to be ineligible for CD services by either the LTSS screening team, DMAS, its designated agent, or the services facilitator. An individual may not begin or continue to receive CD services if there are circumstances where the waiver individual's health, safety, or welfare cannot be assured, including:

a. It is determined that the waiver individual cannot complete the duties of the EOR and no one else is able to assume this role;

b. The waiver individual cannot ensure his own health, safety, or welfare or develop an emergency backup plan that will ensure his health, safety, or welfare; or

c. The waiver individual has medication or skilled nursing needs or medical or behavioral conditions that cannot be met through CD services or other services.

2. The waiver individual may be involuntarily disenrolled from consumer direction if the individual or the EOR, as appropriate, is consistently unable to retain or manage the attendant as may be demonstrated by, but not necessarily limited to, a pattern of serious discrepancies with the attendant's work shift entries or noncompliance with CD EOR requirements.

3. In situations where either (i) the waiver individual's health, safety, or welfare cannot be assured or (ii) attendant work shift entry discrepancies are known, the services facilitator shall assist as requested with the waiver individual's transfer to agency-directed services as follows:

a. Verify that essential training has been provided to the waiver individual or EOR;

b. Document, in the waiver individual's record, the conditions creating the necessity for the involuntary disenrollment and actions taken by the services facilitator;

c. Discuss with the waiver individual or the EOR, as appropriate, the agency-directed option that is available and the actions needed to arrange for such services and offer choice of potential providers; and

d. Provide written notice to the waiver individual of the right to appeal such involuntary termination of consumer direction. Such notice shall be given at least 10 calendar days prior to the effective date of this change. In cases when the individual's or the provider personnel's safety may be in jeopardy, the 10 calendar days' notice shall not apply.

C. Adult day health care (ADHC) services. ADHC services shall only be offered to waiver individuals who meet LTSS screening criteria as established in 12VAC30-60-303 and 12VAC30-60-313 and for whom ADHC services shall be an appropriate and medically necessary alternative to institutional care. ADHC services may be offered to individuals in a VDSS-licensed adult day care center (ADCC) congregate setting. ADHC may be offered either as the sole home and community-based waiver service or in conjunction with personal care (either agency-directed or consumer-directed), respite care (either agency-directed or consumer-directed), or PERS. A multi-disciplinary approach to developing, implementing, and evaluating each waiver individual's POC shall be essential to quality ADHC services.

1. ADHC services shall be designed to prevent institutionalization by providing waiver individuals with health care services, maintenance of the individual's physical and mental conditions, and coordination of rehabilitation services in a congregate daytime setting and shall be tailored to each individual's unique needs. The minimum range of services that shall be made available to every waiver individual shall be: assistance with ADLs, nursing services, coordination of rehabilitation services, nutrition, social services, recreation, and socialization services.

a. Assistance with ADLs shall include supervision of the waiver individual and assistance with management of the individual's POC.

b. Nursing services shall include the periodic evaluation, at least every 90 days, of the waiver individual's nursing needs; provision of indicated nursing care and treatment; responsibility for monitoring, recording, and administering prescribed medications; supervision of the waiver individual in self-administered medication; support of families in their home care efforts for the waiver individuals through education and counseling; and helping families identify and appropriately utilize health care resources. Periodic evaluations may occur more frequently than every 90 days if indicated by the individual's changing condition. Nursing services shall also include the general supervision of provider staff, who are certified through the Board of Nursing, in medication management and administering medications.

c. Coordination and implementation of rehabilitation services to ensure the waiver individual receives all rehabilitative services deemed necessary to improve or maintain independent functioning, to include physical therapy, occupational therapy, and speech therapy.

d. Nutrition services shall be provided to include one or more meals per day that meets the daily nutritional requirements pursuant to 22VAC40-61-360. Special diets and nutrition counseling shall be provided as required or requested by the waiver individual.

e. Recreation and social activities shall be provided that are suited to the needs of the waiver individuals and shall be designed to encourage physical exercise, prevent physical and mental deterioration, and stimulate social interaction.

f. ADHC coordination shall involve implementing the waiver individuals' POCs, updating such plans, recording 30-day progress notes, and reviewing the waiver individuals' daily logs each week.

2. Limits on covered ADHC services.

a. A day of ADHC services shall be defined as a minimum of six hours.

b. ADHCs that do not employ professional nursing staff on site shall not be permitted to admit waiver individuals who require skilled nursing care to their centers. Examples of skilled nursing care may include: (i) tube feedings; (ii) Foley catheter irrigations; (iii) sterile dressing changing; or (iv) any other procedures that require sterile technique. The ADCC shall not permit its aide employees to perform skilled nursing procedures.

c. At any time that the center is no longer able to provide reliable, continuous care to any of the center's waiver individuals for the number of hours per day or days per week as contained in the individuals' POCs, the center shall contact the waiver individuals, family, caregivers, or MCO care coordinators, as appropriate, to initiate other care arrangements for these individuals. The center may either subcontract with another ADCC or may transfer the waiver individual to another ADCC. The center may discharge waiver individuals from the center's services but not from the waiver. Written notice of discharge shall be provided, with the specific reason or reasons for discharge, at least 10 calendar days prior to the effective date of the discharge. In cases when the individual's or the center personnel's safety may be in jeopardy, the 10 calendar days' notice shall not apply.

d. ADHC services shall not be provided, for the purpose of Medicaid reimbursement, to individuals who reside in nursing facilities, intermediate care facilities for individuals with intellectual disabilities, hospitals, assisted living facilities that are licensed by VDSS, or group homes that are licensed by DBHDS.

D. Agency-directed personal care services. Agency-directed personal care services shall be offered to persons who meet the LTSS screening criteria at 12VAC30-60-303 and 12VAC30-60-313 and for whom it shall be an appropriate alternative to institutional care. Agency-directed personal care services shall be comprised of hands-on care of either a supportive or health-related nature and shall include assistance with ADLs, access to the community, assistance with medications in accordance with VDH licensing requirements or other medical needs, supervision, and the monitoring of health status and physical condition. Where the individual requires assistance with ADLs, and when specified in the POC, such supportive services may include assistance with IADLs. This service shall not include skilled nursing services with the exception of skilled nursing tasks (e.g., catheterization) that may be delegated pursuant to Part V (18VAC90-19-240 through 18VAC90-19-280) of 18VAC90-19. Agency-directed personal care services may be provided in a home or community setting to enable an individual to maintain the health status and functional skills necessary to live in the community or participate in community activities. Personal care may be offered either as the sole home and community-based waiver service or in conjunction with adult day health care, respite care (agency-directed or consumer-directed), or PERS. The provider shall document, in the individual's medical record, the waiver individual's choice of the agency-directed model.

1. Criteria. In order to qualify for this service, the waiver individual shall have met the LOC criteria as set out in 12VAC30-60-303 and 12VAC30-60-313 as documented on the UAI assessment form, and for whom it shall be an appropriate alternative to institutional care.

a. A waiver individual may receive both CD and agency-directed personal care services if the individual meets the criteria. Hours received by the individual who is receiving both CD and agency-directed services shall not exceed the total number of hours that would be needed if the waiver individual were receiving personal care services through a single delivery model.

b. CD and agency-directed services shall not be simultaneously provided but may be provided sequentially or alternately from each other.

c. The individual, family, or caregiver shall have a backup plan or caregiver for the provision of services in the event the agency is unable to provide an aide.

2. Limits on covered agency-directed personal care services.

a. DMAS shall not duplicate services that are required as a reasonable accommodation as a part of the Americans with Disabilities Act (42 USC §§ 12131 through 12165) or the Rehabilitation Act of 1973 (29 USC § 794).

b. DMAS or its contractor shall reimburse for services delivered, consistent with the approved POC, for personal care that the personal care aide provides to the waiver individual to assist while at work or postsecondary school or both.

(1) DMAS or the designated service authorization contractor shall review the waiver individual's needs and the complexity of the disability, as applicable, when determining the services that are provided to the individual in the workplace or postsecondary school or both.

(2) DMAS shall not pay for the personal care aide to assist the waiver individual with any functions or tasks related to the individual completing a job or postsecondary school functions or for supervision time during either work or postsecondary school or both.

c. Supervision services shall be authorized to ensure the health, safety, or welfare of the waiver individual who cannot be left alone at any time or is unable to call for help in case of an emergency, and when there is no competent adult in the home able to call for help in case of an emergency.

d. There shall be a maximum limit of eight hours per day for supervision services. Supervision services shall be documented in the POC as needed by the individual.

e. Agency-directed personal care services shall be limited to 56 hours of services per week for 52 weeks per year. Exceptions may be granted based on criteria set forth in 12VAC30-120-927.

f. Electronic visit verification requirements set out in 12VAC30-60-65 shall apply to these agency-directed respite care services.

g. Due to the complex medical needs of waiver individuals requiring PDN services and the need for 24-hour supervision, the trained primary caregiver shall be present in the home and shall render the required skilled services during the entire time that the aide is providing unskilled care.

E. Agency-directed respite care services. Agency-directed respite care services shall be offered to waiver individuals who meet the LTSS screening criteria at 12VAC30-60-303 and 12VAC30-60-313 and for whom it shall be an appropriate alternative to institutional care. Agency-directed respite care services may be either skilled respite or unskilled care and shall be comprised of hands-on care of either a supportive or health-related nature and may include assistance with ADLs, access to the community, assistance with medications in accordance with VDH licensing requirements or other medical needs, supervision, and monitoring health status and physical condition. Skilled respite care shall include skilled nursing care ordered on the physician-certified POC.

1. Respite care shall only be offered to individuals who have an unpaid primary caregiver who requires temporary relief to avoid institutionalization of the waiver individual. Respite care services may be provided in the individual's home or other community settings. Respite shall also be provided in children's residential facilities in accordance with 12VAC30-120-925.

2. When the individual requires assistance with ADLs, and where such assistance is specified in the waiver individual's POC, such supportive services may also include assistance with IADLs.

3. Unskilled respite service shall not include skilled nursing services with the exception of skilled nursing tasks (e.g., catheterization) that may be delegated pursuant to Part V (18VAC90-19-240 through 18VAC90-19-280) of 18VAC90-19.

4. Skilled respite care services.

a. This service shall be provided by skilled nursing staff licensed to practice in the Commonwealth under the direct supervision of a licensed, certified, or accredited home health agency with which DMAS has a provider agreement to provide PDN. Direct supervision means that the supervising RN is immediately accessible by telephone to the RN, LPN, or personal care aide who is delivering waiver-covered services to individuals.

b. Skilled respite care services shall be comprised of both skilled and hands-on care of either a supportive or health-related nature and may include all skilled nursing care as ordered on the physician-certified POC, assistance with ADLs or IADLs, administration of medications or other medical needs, and monitoring of the health status and physical condition of individuals.

c. When skilled respite services are offered in conjunction with PDN, the same individual record may be used with a separate section for skilled respite services documentation. This documentation must be clearly labeled as distinct from PDN services.

d. Individuals who reside in the same house shall be permitted to share skilled respite care service providers. The same limits on this service in the congregate setting (480 hours per calendar year per household) shall apply regardless of the type of waiver.

5. Limits on service.

a. The unit of service shall be one hour. Respite care services shall be limited to 480 hours per individual per calendar year, to be service authorized. No additional respite hours beyond the maximum limit shall be approved for payment for individuals, even those who change waiver programs. Additionally, individuals who are receiving respite services in this waiver through both the agency-directed and CD models shall not exceed 480 hours per calendar year combined.

b. If agency-directed respite care service is the only service received by the waiver individual, it must be received at least as often as every 30 days. If this service is not required at this minimal level of frequency, then the provider or MCO shall notify the local department of social services for its redetermination of eligibility for the waiver individual.

c. The individual, family, or caregiver shall have a backup plan or caregiver for the provision of services in the event the agency is unable to provide an aide.

d. Electronic visit verification requirements set out in 12VAC30-60-65 shall apply to these agency-directed respite care services.

F. Services facilitation for consumer-directed services. Consumer-directed personal care and respite care services shall only be offered to waiver individuals who meet the LTSS screening criteria at 12VAC30-60-303 and 12VAC30-60-313 and for whom there shall be appropriate alternatives to institutional care.

1. Individuals who choose CD services shall receive support from a DMAS-enrolled services facilitator or a provider designated by the managed care organization as required in conjunction with CD services. The services facilitator shall document the waiver individual's choice of the CD model and whether there is a need for another person to serve as the EOR on behalf of the individual. The services facilitator shall be responsible for assessing the waiver individual's particular needs for a requested CD service, assisting in the development of the POC, providing training to the EOR on the EOR's responsibilities as an employer, and for providing ongoing support of the CD services.

2. Individuals who are eligible for CD services shall have an EOR who has the capability to hire, to train, and to fire the personal care attendant and supervise the attendant's performance, including approving the attendant's work shift entries.

a. If a waiver individual is unwilling or unable to direct the individual's own care or is younger than 18 years of age, family, a caregiver, or a designated person shall serve as the EOR on behalf of the waiver individual in order to perform these supervisory and work shift entry approval functions.

b. Specific employer duties shall include checking references of personal care attendants and determining that personal care attendants meet qualifications.

3. The individual, family, or caregiver shall have a backup plan or caregiver for the provision of services in case the attendant does not show up for work as scheduled or terminates employment without prior notice.

4. The services facilitator shall not be the waiver individual, a CD attendant, a provider of other Medicaid-covered services, the spouse of the waiver individual, the natural, adoptive, step, or foster parent or other legal guardian of the waiver individual who is a minor, or the EOR who is employing the CD attendant.

5. DMAS or the MCO shall either provide for fiscal/employer agent services or contract for the services of a fiscal/employer agent for CD services. The fiscal/employer agent shall be reimbursed by DMAS or the DMAS contractor to perform certain tasks as an agent for the EOR. The fiscal/employer agent shall handle responsibilities for the waiver individual, including payroll, employment taxes, and background checks for attendants. The fiscal/employer agent shall seek and obtain all necessary authorizations and approvals of the Internal Revenue Service in order to fulfill all of these duties.

G. Consumer-directed personal care services. CD personal care services shall be comprised of hands-on care of either a supportive or health-related nature and shall include assistance with ADLs, access to the community, monitoring of self-administered medications or other medical needs, supervision, and the monitoring of health status and physical condition. Where the waiver individual requires assistance with ADLs, and when specified in the POC, such supportive services may include assistance with IADLs. This service shall not include skilled nursing services with the exception of skilled nursing tasks (e.g., catheterization) that may be delegated pursuant to Part V (18VAC90-19-240 through 18VAC90-19-280) of 18VAC90-19 and as permitted by Chapter 30 (§ 54.1-3000 et seq.) of Title 54.1 of the Code of Virginia. CD personal care services may be provided in a home or community setting to enable an individual to maintain the health status and functional skills necessary to live in the community or participate in community activities. Personal care may be offered either as the sole home and community-based waiver service or in conjunction with adult day health care, respite care (agency-directed or consumer-directed), or PERS.

1. In order to qualify for this service, the waiver individual shall have met the LOC criteria as set out in 12VAC30-60-303 and 12VAC30-60-313 as documented on the UAI assessment instrument, and for whom it shall be an appropriate alternative to institutional care.

a. A waiver individual may receive both CD and agency-directed personal care services if the individual meets the criteria. Hours received by the waiver individual who is receiving both CD and agency-directed services shall not exceed the total number of hours that would be otherwise authorized had the individual chosen to receive personal care services through a single delivery model.

b. CD and agency-directed services shall not be simultaneously provided but may be provided sequentially or alternately from each other.

2. Limits on covered CD personal care services.

a. DMAS shall not duplicate services that are required as a reasonable accommodation as a part of the Americans with Disabilities Act (42 USC §§ 12131 through 12165) or the Rehabilitation Act of 1973 (29 USC § 794).

b. There shall be a limit of eight hours per day for supervision services included in the POC. Supervision services shall be authorized to ensure the health, safety, or welfare of the waiver individual who cannot be left alone at any time or is unable to call for help in case of an emergency, and when there is no other competent adult able to call for help in case of an emergency.

c. Consumer-directed personal care services shall be limited to 56 hours of services per week for 52 weeks per year. Exceptions may be granted based on criteria set forth in 12VAC30-120-927.

d. Electronic visit verification requirements as set out in 12VAC30-60-65 shall apply to these CD personal care services.

e. Due to the complex medical needs of waiver individuals requiring PDN services and the need for 24-hour supervision, the trained primary caregiver shall be present in the home and shall render the required skilled services during the entire time that the attendant is providing unskilled care.

3. CD personal care services at work or school shall be limited as follows:

a. DMAS or its contractor shall reimburse for services delivered, consistent with the approved POC, for CD personal care that the attendant provides to the waiver individual to assist while at work or postsecondary school or both.

b. DMAS or the designated service authorization contractor shall review the waiver individual's needs and the complexity of the disability, as applicable, when determining the services that will be provided to the individual in the workplace or postsecondary school or both.

c. DMAS shall not pay for the personal care attendant to assist the waiver individual with any functions or tasks related to the individual completing a job or postsecondary school functions or for supervision time during work or postsecondary school or both.

H. Consumer-directed respite care services. CD respite care services are unskilled care and shall be comprised of hands-on care of either a supportive or health-related nature and may include assistance with ADLs, access to the community, monitoring of self-administration of medications or other medical needs, supervision, monitoring health status and physical condition, and personal care services in a work environment.

1. In order to qualify for this service, the waiver individual shall have met the LOC criteria as set out in 12VAC30-60-303 and 12VAC30-60-313 as documented on the UAI form, and for whom it shall be an appropriate alternative to institutional care.

2. CD respite care services shall only be offered to individuals who have an unpaid primary caregiver who requires temporary relief to avoid institutionalization of the waiver individual. This service shall be provided in the waiver individual's home or other community settings.

3. When the waiver individual requires assistance with ADLs, and where such assistance is specified in the individual's POC, such supportive services may also include assistance with IADLs.

4. Electronic visit verification requirements as set out in 12VAC30-60-65 shall apply to these CD respite care services.

5. Limits on covered CD respite care services.

a. The unit of service shall be one hour. Respite care services shall be limited to 480 hours per waiver individual per calendar year. If a waiver individual changes waiver programs, this same maximum number of respite hours shall apply. No additional respite hours beyond the 480 maximum limit shall be approved for payment. Individuals who are receiving respite care services in this waiver through both the agency-directed and CD models shall not exceed 480 hours per calendar year combined.

b. CD respite care services shall not include skilled nursing services with the exception of skilled nursing tasks (e.g., catheterization) that may be delegated pursuant to Part V (18VAC90-19-240 through 18VAC90-19-280) of 18VAC90-19 and as permitted by Chapter 30 (§ 54.1-3000 et seq.) of Title 54.1 of the Code of Virginia).

c. If consumer-directed respite care service is the only service received by the waiver individual, it shall be received at least as often as every 30 days. If this service is not required at this minimal level of frequency, then the services facilitator or MCO shall refer the waiver individual to the local department of social services for its redetermination of Medicaid eligibility for the waiver individual.

I. Personal emergency response system (PERS).

1. Service description. PERS is a service that monitors the individual's safety in the home and provides access to emergency assistance for medical or environmental emergencies through the provision of a two-way voice communication system that dials a 24-hour response or monitoring center upon activation and via the individual's home telephone line or system. PERS may also include medication monitoring devices.

a. PERS shall be authorized only when there is no other competent adult in the home who is available to call for help in an emergency or when the individual's health, safety, and welfare cannot be ensured.

b. The use of PERS equipment shall not relieve the primary or backup caregiver of the caregiver's responsibilities.

c. Service units and service limitations.

(1) PERS shall be limited to waiver individuals who are ages 14 years and older who also either live alone or are alone for significant parts of the day and who have no regular caregiver for extended periods of time. PERS shall only be provided in conjunction with receipt of personal care services (either agency-directed or consumer-directed), respite services (either agency-directed or consumer-directed), or adult day health care. A waiver individual shall not receive PERS if the individual has a cognitive impairment as defined in 12VAC30-120-900.

(2) A unit of service shall include administrative costs, time, labor, and supplies associated with the installation, maintenance, monitoring, and adjustments of the PERS. A unit of service shall be the one-month rental price set by DMAS in its fee schedule. The one-time installation of the unit shall include installation, account activation, individual and family or caregiver instruction, and subsequent removal of PERS equipment when it is no longer needed.

(3) PERS services shall be capable of being activated by a remote wireless device and shall be connected to the waiver individual's telephone line or system. The PERS console unit must provide hands-free voice-to-voice communication with the response center. The activating device must be (i) waterproof, (ii) able to automatically transmit to the response center an activator low battery alert signal prior to the battery losing power, (iii) able to be worn by the waiver individual, and (iv) automatically reset by the response center after each activation, thereby ensuring that subsequent signals can be transmitted without requiring manual resetting by the waiver individual.

(4) All PERS equipment shall be approved by the Federal Communications Commission and meet the Underwriters' Laboratories, Inc. (UL) safety standard.

(5) Medication monitoring units shall be physician ordered. In order to be approved to receive the medication monitoring service, a waiver individual shall also receive PERS services. Physician orders shall be maintained in the waiver individual's record. In cases where the medical monitoring unit must be filled by the provider, the person who is filling the unit shall be either an RN or an LPN. The units may be filled as frequently as a minimum of every 14 days. There must be documentation of this action in the waiver individual's record.

J. Transition services. Transition services, as defined at 12VAC30-120-2010, provide for individuals to move from institutional placements or licensed or certified provider-operated living arrangements to private homes or other qualified settings. The individual's transition from an institution to the community shall be coordinated by the facility's discharge planning team. The discharge planner shall ensure that CCC Plus Waiver eligibility criteria shall be met.

1. Transition services shall be authorized by DMAS or its designated agent in order for reimbursement to occur.

2. To qualify for the service, the waiver individual shall be discharged after 90 consecutive days of residence from an institution, intermediate care facility for individuals with intellectual disabilities, institution for mental disease, or psychiatric residential treatment facility.

3. Transition services shall be provided in conjunction with personal care (agency-directed or consumer-directed), respite care (agency-directed or consumer-directed), private duty nursing, or adult day health care services.

4. Transition services may be provided by DMAS enrolled area agencies on aging, centers for independent living, and local departments of social services.

K. Assistive technology (AT).

1. Assistive technology (AT) shall be portable and shall be authorized per calendar year. AT services are the specialized medical equipment and supplies, including those devices, controls, or appliances, specified in the individual's plan of care, but that are not available under the State Plan for Medical Assistance, that enable a waiver individual to increase the individual's ability to perform ADLs or IADLs or to perceive, control, or communicate with the environment in which the individual lives.

2. In order to qualify for these services, the individual shall have a demonstrated need for specialized medical equipment and supplies for remedial or direct medical benefit primarily in an individual's primary home, primary vehicle used by the individual, community activity setting, or day program to specifically serve to improve the individual's personal functioning. This shall encompass those items not otherwise covered under the State Plan for Medical Assistance. AT shall be covered in the least expensive manner.

3. AT services shall be available for a waiver individual who has a demonstrated need for equipment for remedial or direct medical benefit. This service includes ancillary supplies and equipment necessary for the proper functioning of such items.

4. Service units and service limitations.

a. The cost for AT shall not be carried over from one calendar year to the next. Each item must be service authorized by either DMAS or the DMAS-designated service authorization contractor for each calendar year.

b. The maximum funded expenditure per individual for all AT covered procedure codes (combined total of AT items and labor related to these items) shall be $5,000 per calendar year for an individual regardless of waiver, or regardless of whether the individual changes waiver programs, for which AT is approved. The service unit shall always be one, for the total cost of all AT being requested for a specific timeframe.

c. AT may be provided in the individual's home or community setting.

d. AT shall not be approved for purposes of convenience of the caregiver or provider or restraint of the individual, recreation or leisure, educational purposes, or diversion activities.

e. AT shall be carried out in the least expensive manner possible to achieve the goal required for the individual's health, safety, and welfare. AT shall be reimbursed in a manner that is reasonable and customary not to exceed the provider's usual and customary charges to the general public.

f. An independent, professional consultation shall be obtained from a qualified professional who is knowledgeable of that item for each AT request prior to approval by the service authorization contractor or managed care organization and may include training on such AT by the qualified professional. The consultation shall not be performed by the provider of AT to the individual.

g. All AT shall be authorized by DMAS, the designated service authorization contractor, or managed care organization prior to billing or providing services to the individual.

h. Items that are reasonable accommodation requirements of the Americans with Disabilities Act, the Virginians with Disabilities Act (§ 51.5-1 et seq. of the Code of Virginia), or the Rehabilitation Act (20 USC § 794) or are required to be provided through other funding sources shall be excluded from Medicaid coverage. DMAS shall not duplicate services that are required as a reasonable accommodation as a part of the Americans with Disabilities Act (42 USC §§ 12131 through 12165), Virginians with Disabilities Act (§ 51.5-1 et seq. of the Code of Virginia), or the Rehabilitation Act of 1973 (29 USC § 794).

i. AT services or equipment shall not be rented but shall be purchased.

j. Shipping, freight, or delivery charges shall not be billable to DMAS or the waiver individual, as such charges are considered noncovered items.

(1) All products shall be delivered, demonstrated, and installed and in working order prior to submitting any claim for them to Medicaid.

(2) The date of service on the claim shall be within the service authorization approval dates, which may be prior to the delivery date as long as the initiation of services commenced during the approved dates.

(3) The service authorization shall not be modified to accommodate delays in product deliveries. In such situations, the provider must seek a new service authorization.

(4) When two or more waiver individuals live in the same home or congregate living arrangement, the AT shall be shared to the extent practicable consistent with the type of AT and the needs of the individuals as documented in their POCs. There shall be no duplication of AT in the same house when such product can be used for a communal purpose.

k. Assistive technology shall not be available to individuals younger than 21 years of age through the CCC Plus Waiver. Assistive technology for individuals younger than 21 shall be accessed through the EPSDT benefit.

l. AT exclusions.

(1) Medicaid shall not reimburse for any AT devices or services that may have been rendered prior to authorization from DMAS or the designated service authorization contractor.

(2) Providers that supply AT for the waiver individual may not perform assessments, consultations, or write specifications for that individual. Any request for a change in cost (either an increase or a decrease) requires justification and supporting documentation of medical need and service authorization by DMAS or the designated service authorization contractor. The vendor shall receive a copy of the professional evaluation in order to purchase the items recommended by the professional. If a change is necessary, the vendor shall notify the assessor to ensure the changed items meet the individual's needs.

(3) All equipment or supplies already covered by a service provided for in the State Plan shall not be purchased under the waiver as AT. Such examples include:

(a) Specialized medical equipment, durable or nondurable medical equipment, ancillary equipment, and supplies necessary for life support;

(b) Adaptive devices, appliances, and controls that enable an individual to be more independent in areas of personal care and ADLs or IADLs; and

(c) Equipment and devices that enable an individual to communicate more effectively.

L. Environmental modifications (EM).

1. Environmental modifications (EM) shall consist of adaptations documented in the waiver individual's POC and may include the installation of nonportable ramps and grab-bars, widening of doorways, modification of bathroom facilities, or installation of specialized electrical and plumbing systems that are necessary to accommodate the medical equipment and supplies that are necessary for the health, safety, and welfare of the waiver individual. Excluded are those adaptations or improvements to the home that are of general utility and are not of direct medical or remedial benefit to the individual, such as carpeting, flooring, roof repairs, central air conditioning, or decks. Adaptations that add to the total square footage of the home shall be excluded from this benefit, except when necessary to complete an authorized adaptation, as determined by DMAS or its designated agent. All services shall be provided in the individual's primary home in accordance with applicable state or local building codes. All modifications shall be prior authorized by the service authorization contractor or managed care organization. Modifications may only be made to a vehicle if it is the primary vehicle being used by the waiver individual. This service does not include the purchase or lease of vehicles. This service shall not include general repairs to a residence or vehicle.

2. In order to qualify for these services, the waiver individual shall have a demonstrated need for modifications of a remedial or direct medical benefit offered in the individual's primary home or primary vehicle to ensure the individual's health, welfare, or safety or specifically to improve the individual's personal functioning. Modifications may include a generator for a waiver individual who is dependent on mechanical ventilation for 24 hours a day and when the generator is used to support the medical equipment and supplies necessary for the individual's welfare. This service shall encompass those items not otherwise covered in the State Plan for Medical Assistance or through another program. EM shall be covered in the least expensive manner.

3. Service units and service limitations.

a. The maximum funded expenditure per individual for all EM covered procedure codes (combined total of EM items and labor related to these items) shall be $5,000 per calendar year for an individual regardless of waiver, or regardless of whether the individual changes waiver programs, for which EM is approved. Unexpended portions of this maximum amount shall not be accumulated across one or more years to be expended in a later year. The service unit shall always be one, for the total cost of all EM being requested for a specific timeframe.

b. All EM shall be authorized by DMAS or the DMAS-designated service authorization contractor prior to billing or providing services to the individual.

c. Modifications shall not be used to bring a substandard dwelling up to minimum habitation standards.

d. EM shall not be approved for purposes of convenience of the caregiver or provider or restraint of the waiver individual.

e. Only the actual cost of material and labor is reimbursed. There shall be no additional markup.

f. EM shall be carried out in the least expensive manner possible to achieve the goal required for the individual's health, safety, and welfare.

g. All services shall be provided in the individual's primary residence in accordance with applicable state or local building codes and appropriate permits or building inspections, which shall be provided to DMAS or the DMAS contractor.

h. Proposed modifications that are to be made to rental properties shall have prior written approval of the property's owner. Modifications to rental properties shall only be valid if it is an independently operated rental facility with no direct or indirect ties to any other Medicaid service provider.

i. Modifications may be made to a vehicle if it is the primary vehicle used by the individual. This service shall not include the purchase of, lease of, or the general repair of vehicles. Repairs of modifications that have been reimbursed by DMAS shall be covered.

j. The EM provider shall ensure that all work and products are delivered, installed, and in good working order prior to seeking reimbursement from DMAS. The date of service on this provider's claim shall be within the service authorization approval dates, which may be prior to the completion date as long as the work commenced during the approval dates. The service authorization shall not be modified to accommodate installation delays. All requests for cost changes (either increases or decreases) shall be submitted to DMAS or the DMAS-designated service authorization contractor for revision to the previously issued service authorization and shall include justification and supporting documentation of medical needs.

k. DMAS shall not duplicate services that are required as a reasonable accommodation as a part of the Americans with Disabilities Act (42 USC §§ 12131 through 12165), the Virginians with Disabilities Act (§ 51.5-1 et seq. of the Code of Virginia), or the Rehabilitation Act of 1973 (29 USC § 794).

4. EM exclusions.

a. There shall be no duplication of previous EM services within the same residence such as multiple nonportable wheelchair ramps or previous modifications to the same room.

b. Adaptations or improvements to the primary home that shall be excluded are of general utility and are not of direct medical or remedial benefit to the waiver individual, such as, but not limited to, carpeting; flooring; roof repairs; central air conditioning or heating; general maintenance and repairs to a home; additions or maintenance of decks or fences; maintenance, replacement, or addition of sidewalks, driveways, or carports; or adaptations that only increase the total square footage of the home.

c. EM shall not be covered by Medicaid for general leisure or diversion items, items that are recreational in nature, items for educational purposes, or items that may be used as an outlet for adaptive or maladaptive behavioral issues. Such noncovered items may include swing sets, playhouses, climbing walls, trampolines, protective matting or ground cover, sporting equipment, hot tubs, or exercise equipment, such as special bicycles or tricycles.

d. EM shall not be covered by Medicaid if payment for such modifications can be made through the Fair Housing Act (42 USC § 3601 et seq.), the Virginia Fair Housing Law (§ 36-96.1 et seq. of the Code of Virginia) or the Americans with Disabilities Act (42 USC § 12101 et seq.).

e. EM shall not include the costs of removal or disposal, or any other costs, of previously installed modifications, whether paid for by DMAS or any other source.

f. Providers who supply EM to a waiver individual shall not perform assessments, consultations, or write EM specifications for such individuals .

g. EM shall not cover payment for modifications or items that can be made through other Medicaid services, such as durable medical equipment.

M. Private duty nursing. PDN for a single individual and individuals residing in the same home, as defined in 12VAC30-120-900, shall be provided for individuals who have serious medical conditions or complex health care needs. To receive this service, an individual must require specific skilled and continuous nursing care on a regularly scheduled or intermittent basis performed by an RN or an LPN. Once waiver eligibility has been determined by the LTSS screening team and a determination that the individual requires ongoing skilled nursing care has been made, then the PDN hours shall be authorized by DMAS or the DMAS-designated service authorization contractor.

1. PDN services shall be rendered according to a POC authorized by DMAS or the DMAS-designated service authorization contractor and shall have been certified by a physician as medically necessary to enable the individual to remain at home.

2. No reimbursement shall be provided by DMAS for either RN or LPN services without signed physician orders that specifically identify skilled nursing tasks to be performed for the individual.

3. Limits placed on the amount of PDN that will be approved for reimbursement shall be consistent with the individual's support needs and medical necessity but shall not exceed 112 hours per week. The maximum PDN hours authorized per week for individuals shall be based on their technology and documented medical necessity justification.

4. For individuals, whether living separately or in a congregate setting, PDN shall be reimbursed up to a maximum 112 hours per week (Sunday through Saturday) per waiver individual living in the household.

5. The individual shall be determined to need a medical device and ongoing skilled nursing care when such individual meets Category A or all eight criteria in Category B:

a. Category A. Individuals who depend on mechanical ventilators; or

b. Category B. Individuals who have a complex tracheostomy as defined by:

(1) Tracheostomy with the potential for weaning off of it, or documentation of attempts to wean, with subsequent inability to wean;

(2) Nebulizer treatments ordered at least four times a day or nebulizer treatments followed by chest physiotherapy provided by a nurse or respiratory therapist at least four times a day;

(3) Pulse oximetry monitoring at least every shift due to unstable oxygen saturation levels;

(4) Respiratory assessment and documentation every shift by a licensed respiratory therapist or nurse;

(5) Oxygen therapy with documented usage under a physician's order;

(6) Daily tracheostomy care;

(7) Tracheostomy suctioning under a physician's order; and

(8) At risk of requiring subsequent mechanical ventilation.

6. PDN shall not be available to individuals younger than 21 years of age as a waiver service. PDN for individuals younger than 21 shall be accessed through the EPSDT benefit.

7. PDN services may include consultation and training for the primary caregiver.

8. The provider shall be responsible for notifying the LDSS, the service authorization contractor, and the managed care organization should the primary residence of the individual be changed, should the individual be hospitalized, should the individual die, or should the individual be absent from the Commonwealth for 48 hours or more.

9. Exclusions from DMAS coverage of PDN:

a. PDN hours shall not be reimbursed while the individual is receiving emergency care or during emergency transport of the individual to emergency care facilities. The RN or LPN shall not transport the waiver individual to emergency care facilities.

b. PDN services may be ordered but shall not be provided simultaneously with skilled respite care or personal care services. These services may be provided sequentially or alternately from each other.

c. Providers shall not bill prior to receiving the physician's dated signature on the individual's POC for services provided and DMAS or DMAS-designated service authorization contractor's authorization or determination of PDN hours.

d. Time spent transporting the waiver individual shall not be reimbursed by DMAS.

e. DMAS shall not reimburse for PDN services through the CCC Plus Waiver and PDN services through the EPSDT benefit at the same time.

10. Congregate PDN.

a. If more than one waiver individual resides in the home, the same waiver provider shall be chosen to provide all PDN services for all waiver individuals in the home.

b. Only one nurse shall be authorized to care for no more than two waiver individuals in such arrangements. In instances when three waiver individuals share a home, nursing ratios shall be determined by DMAS or its designated agent based on the needs of all the individuals who are living together. These congregate PDN hours shall be at the same scheduled shifts.

c. The unpaid primary caregiver shall be shared and shall be responsible for providing all care needs when a private duty nurse is not available.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 31, Issue 10, eff. February 12, 2015; amended, Virginia Register Volume 40, Issue 20, eff. June 19, 2024.

12VAC30-120-925 Respite coverage in children's residential facilities

A. Individuals who have a diagnosis of intellectual disability (ID) or developmental disability (DD) shall be eligible to receive respite services in children's residential facilities that are licensed for respite services for children with ID or DD.

B. These respite services shall be covered consistent with the requirements of 12VAC30-120-924, 12VAC30-120-930, and 12VAC30-120-935, whichever is in effect at the time of service delivery with the following exceptions:

1. An assessment by the nurse supervisor shall be conducted at the onset of each use of respite in the children's residential facility;

2. Documentation of each utilization of respite in a children's residential facility will document the arrival and departure times of the individual instead of the arrival and departure times of each staff member; and

3. The nurse supervisor shall review the utilization of respite services in the children's residential facility. The nurse supervisor shall not be required to conduct the supervisory visit in the home of the waiver individual.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 6, eff. January 1, 2012; amended, Virginia Register Volume 31, Issue 10, eff. February 12, 2015; Volume 40, Issue 20, eff. June 19, 2024.

12VAC30-120-927 Exception criteria for personal care services

DMAS shall apply the following criteria to individuals who request approval of personal care hours in excess of the maximum allowed 56 hours per week. In order to qualify for personal care hours in excess of 56 hours per week, the waiver individual shall:

1. Presently have a minimum level of care of B (the waiver individual has a composite activities of daily living (ADL) score between seven and 12 and has a medical nursing need) or C (the waiver individual has a composite ADL score of nine or higher and has a skilled medical nursing need).

2. In addition to meeting the requirements set out in subdivision 1 of this section, the individual shall have at least one of the following:

a. Documentation of dependencies in all of the following activities of daily living: bathing, dressing, transferring, toileting, and eating or feeding, as defined by the current LTSS screening criteria (12VAC30-60-303) submitted to the service authorization contractor via DMAS-99;

b. Documentation of dependencies in both behavior and orientation as defined by the current LTSS screening criteria (12VAC30-60-303) submitted to the service authorization contractor via DMAS-99; or

c. Documentation from the local department of social services that the individual has an open case (as described in subdivisions 2 c (1) and 2 c (2) of this section) with either adult protective services (APS) or child protective services (CPS) and is therefore in need of additional services beyond the maximum allowed 56 hours per week. Documentation can be in the form of a phone log contact or any other documentation supplied (submitted to the service authorization contractor via attestation).

(1) For APS, an open case is defined as a substantiated APS case with a disposition of needs protective services and the adult accepts the needed services.

(2) For CPS, an open case is defined as being open to CPS investigation if it is both founded by the investigation and the completed family assessment documents the case with moderate or high risk.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 7, eff. December 30, 2015; amended, Virginia Register Volume 40, Issue 20, eff. June 19, 2024.

12VAC30-120-930 General requirements for home and community-based participating providers

A. The following agency-directed services shall be provided through an agency that is either (i) licensed by VDH, (ii) certified by VDH under provisions of Title XVIII or Title XIX of the Social Security Act, or (iii) accredited either by the Joint Commission on Accreditation of Health Care Organizations (JCAHO) or by the Community Health Accreditation Program (CHAP) established by the National League of Nursing for Medicaid participation: personal care, respite care, PDN, skilled respite care, and congregate PDN. The provider shall make available verification of its license, certification, or accreditation upon request.

B. Requests for participation shall be screened by DMAS or the designated DMAS contractor to determine whether the provider applicant meets the requirements for participation, as set forth in the provider agreement, and demonstrates the abilities to perform, at a minimum, the following activities:

1. Screen all new and existing employees and contractors to determine whether any are excluded from eligibility for payment from federal health care programs, including Medicaid (i.e., via the United States Department of Health and Human Services Office of Inspector General List of Excluded Individuals or Entities (LEIE) website). Immediately report in writing to DMAS any exclusion information discovered to: DMAS, ATTN: Program Integrity/Exclusions, 600 East Broad Street, Suite 1300, Richmond, VA 23219, or email to providerexclusions@dmas.virginia.gov;

2. Immediately notify DMAS in writing of any change in the information that the provider previously submitted to DMAS;

3. Ensure freedom of choice to individuals in seeking services from any institution, pharmacy, practitioner, or other provider qualified and enrolled in Medicaid at the time of delivery to perform the service required, except for waiver individuals who are subject to the DMAS Client Medical Management program as set out in Part XIII of 12VAC30-130 or are enrolled in a Medicaid managed care organization;

4. Ensure the individual's freedom to refuse medical care, treatment, and services;

5. Accept referrals for services only when staff is available to initiate and perform such services on an ongoing basis;

6. Provide services and supplies to individuals in full compliance with Title VI (42 USC § 2000d et seq.) of the Civil Rights Act of 1964, which prohibits discrimination on the grounds of race, color, religion, or national origin; the Virginians with Disabilities Act (§ 51.5-1 et seq. of the Code of Virginia); § 504 of the Rehabilitation Act of 1973 (29 USC § 794), which prohibits discrimination on the basis of a disability; and the Americans with Disabilities Act of 1990 (42 USC § 12101 et seq.), which provides comprehensive civil rights protections to individuals with disabilities in the areas of employment, public accommodations, state and local government services, and telecommunications;

7. Provide services and supplies to individuals of the same quality and in the same mode of delivery as are provided to the general public;

8. Submit charges to DMAS, the MCO, or the DMAS-designated service authorization contractor for the provision of services and supplies to individuals in amounts not to exceed the provider's usual and customary charges to the general public and accept as payment in full the amount established by DMAS payment methodology beginning with the individual's authorization date for the waiver services;

9. Use only DMAS-designated forms for service documentation, except when otherwise permitted. The provider shall not alter the DMAS forms in any manner without prior written approval from DMAS;

10. Use DMAS-designated billing forms for submission of charges;

11. Perform no type of direct marketing activities to Medicaid individuals;

12. Maintain and retain business and professional records sufficient to document fully and accurately the nature, scope, and details of the services provided.

a. In all instances of forms required to be in records, all documents shall have original notes, dates, and signatures. Copied, re-dated, and photocopied forms, notes and signatures are prohibited. Signatures shall not be dated prior to the last date of rendered services for the appropriate form being used.

b. In general, such records shall be retained for a period of at least six years from the last date of service or as provided by applicable federal and state laws, whichever period is longer. However, if an audit is initiated within the required retention period, the records shall be retained until the audit is completed and every exception resolved. Records of minors shall be kept for a period of at least six years after such minor has reached 18 years of age.

c. Policies regarding retention of records shall apply even if the provider discontinues operation. DMAS shall be notified in writing of the storage location and procedures for obtaining records for review should the need arise. The location, agent, or trustee shall be within the Commonwealth;

13. Furnish information on the request of and in the form requested to DMAS or its contractors, the Attorney General of Virginia or their authorized representatives, federal personnel, and the state Medicaid Fraud Control Unit. The Commonwealth's right of access to provider agencies and records shall survive any termination of the provider agreement;

14. Disclose, as requested by DMAS, all financial, beneficial, ownership, equity, surety, or other interests in any and all firms, corporations, partnerships, associations, business enterprises, joint ventures, agencies, institutions, or other legal entities providing any form of health care services to recipients of Medicaid;

15. Pursuant to 42 CFR 431.300 et seq., § 32.1-325.3 of the Code of Virginia, and the Health Insurance Portability and Accountability Act (HIPAA), safeguard and hold confidential all information associated with an applicant or enrollee or individual that could disclose the identity of the applicant, enrollee, or individual. Access to information concerning the applicant, enrollee, or individual shall be restricted to persons or agency representatives who are subject to the standards of confidentiality that are consistent with that of the agency and any such access must be in accordance with the provisions found in 42 CFR 431.306 and 12VAC30-20-90;

16. When ownership of the provider changes, notify DMAS in writing at least 15 calendar days before the date of change;

17. Pursuant to §§ 63.2-100, 63.2-1509, and 63.2-1606 of the Code of Virginia, if a participating provider or the provider's staff knows or suspects that a home and community-based waiver services individual is being abused, neglected, or exploited, the party having knowledge or suspicion of the abuse, neglect, or exploitation shall report this immediately to the local department of social services adult or child protective services department as applicable or to the toll-free, 24-hour hotline as described on the local department of social services' website. Employers shall ensure and document that their staff is aware of this requirement;

a. The party having knowledge or suspicion of abuse, neglect, or exploitation shall also report this immediately to DMAS or its authorized contractor separately as a critical incident. The provider shall ensure that in such instances of suspected or known abuse, neglect, or exploitation that DMAS or its authorized contractor are informed after notifying adult or child protective services and will document the date and time of report.

b. If a participating provider or the provider's staff knows or suspects that a waiver individual has incurred a critical incident that does not include suspected or known abuse, neglect, or exploitation, the party having knowledge or suspicion of the critical incident shall report this immediately to DMAS or the DMAS-designated contractor. Employers shall ensure and document that their staff is aware of this requirement and maintain copies of all records of reported critical incidents in the individual's file.

18. In addition to compliance with the general conditions and requirements, adhere to the conditions of participation outlined in the provider's participation agreements, in the applicable DMAS provider manual, and in other DMAS laws, regulations, and policies. DMAS shall conduct ongoing monitoring of compliance with provider participation standards and DMAS policies. A provider's noncompliance with DMAS policies and procedures may result in a retraction of Medicaid payment or termination of the provider agreement, or both;

19. Meet minimum qualifications of staff.

a. For reasons of Medicaid individuals' safety and welfare, all employees shall have a satisfactory work record, as evidenced by at least two references from prior job experience, including no evidence of abuse, neglect, or exploitation of incapacitated or older adults or children. In instances of employees who have worked for only one employer, such employees shall be permitted to provide one appropriate employment reference and one appropriate personal reference including no evidence of abuse, neglect, or exploitation of incapacitated or older adults or children.

b. Pursuant to 42 CFR 441.302 and 42 CFR 441.352, within 30 calendar days of employment, the staff or volunteer shall obtain an original criminal record clearance with respect to convictions for offenses specified in § 19.2-392.02 of the Code of Virginia or an original criminal history record from the Central Criminal Records Exchange.

(1) DMAS shall not reimburse a provider for services provided by a staff member or volunteer who works in a position that involves direct contact with a waiver individual until an original criminal record clearance or original criminal history record has been received. DMAS shall reimburse services provided by such staff member or volunteer during only the first 30 calendar days of employment if the provider can produce documented evidence that such person worked only under the direct supervision of another staff member or volunteer for whom a background check was completed in accordance with the requirements of this section. If an original criminal record clearance or original criminal history record is not received within the first 30 calendar days of employment, DMAS shall not reimburse the provider for services provided by such employee on the 31st calendar day through the date on which the provider receives an original criminal record clearance or an original criminal history record.

(2) DMAS shall not reimburse a provider for services provided by a staff member or volunteer who has been convicted of any offense set forth in clause (i) of the definition of barrier crime in § 19.2-392.02 of the Code of Virginia unless all of the following conditions are met: (i) the offense was punishable as a misdemeanor; (ii) the staff member or volunteer has been convicted of only one such offense; (iii) the offense did not involve abuse or neglect; and (iv) at least five years have elapsed since the conviction.

c. The staff or volunteer shall provide the hiring facility with a sworn statement or affirmation disclosing any criminal convictions or any pending criminal charges, whether within or outside of the Commonwealth.

d. Provider staff and volunteers shall not be debarred, suspended, or otherwise excluded from participating in federal health care programs, as listed on the federal List of Excluded Individuals/Entities (LEIE) database at https://oig.hhs.gov.

e. Provider staff and volunteers who serve waiver individuals who are minor children shall be screened through the VDSS Child Protective Services (CPS) Central Registry. Provider staff and volunteers shall not be reimbursed for services provided to the waiver individual effective on the date and thereafter that the VDSS CPS Central Registry check confirms the provider's staff person or volunteer has a finding.

20. Comply with the electronic visit verification requirements set out in 12VAC30-60-65.

21. Providers shall comply with requirements for person-centered planning and home and community-based settings as described in 42 CFR 441.301. As part of the person-centered planning process, providers shall discuss the available services to the individual to meet the individual's needs and shall not perform services that are not identified or agreed upon in the person-centered plan.

C. DMAS shall terminate the provider's Medicaid provider agreement pursuant to § 32.1-325 of the Code of Virginia and as may be required for federal financial participation. A provider who has been convicted of a felony, or who has otherwise pled guilty to a felony, in Virginia or in any other of the 50 states, the District of Columbia, or the U.S. territories shall within 30 days of such conviction notify DMAS of this conviction and relinquish its provider agreement. Such provider agreement terminations, subject to applicable appeal rights, shall conform to § 32.1-325 D and E of the Code of Virginia and Part XII (12VAC30-20-500 et seq.) of 12VAC30-20.

D. Home and community-based waiver services providers shall meet the following standards:

1. Staffing, financial solvency, disclosure of ownership, and ensuring comparability of services requirements as specified in the applicable provider manual;

2. The ability to document and to maintain waiver individuals' case records in accordance with state and federal requirements;

3. Compliance with all applicable laws, regulations, and policies pertaining to CCC Plus Waiver services.

E. The waiver individual shall have the option of selecting a Medicaid-enrolled provider that can appropriately meet the individual's needs.

F. A participating provider may voluntarily terminate its participation in Medicaid by providing 30 days' written notification to DMAS.

G. Except as otherwise provided by state or federal law, DMAS may terminate at will a provider's participation agreement on 30 days' written notice as specified in the DMAS participation agreement. DMAS may immediately terminate a provider's participation agreement if the provider is no longer eligible to participate in the Medicaid program. Such action precludes further payment by DMAS for services provided to individuals on or after the date specified in the termination notice.

H. The provider or the managed care organization shall be responsible for completing the DMAS-225 form to notify the designated service authorization contractor and the local department of social services when any of the following events occur:

1. Home and community-based waiver services are started;

2. A waiver individual dies;

3. A waiver individual is discharged from the provider's CCC Plus Waiver services;

4. Any other events (including hospitalization) that cause home and community-based waiver services to cease or be interrupted for more than 30 consecutive calendar days; or

5. Changes in the individual's status that may affect the individual's patient pay amount or financial Medicaid eligibility.

I. Changes or termination of services.

1. The provider may decrease the amount of authorized care if the revised POC is appropriate and based on the medical needs of the waiver individual. The participating provider shall collaborate with the waiver individual or the family, caregiver, or EOR, as appropriate, to develop the new POC and calculate the new hours of service delivery. The provider shall discuss the decrease in care with the waiver individual or family, caregiver, or EOR, document the conversation in the waiver individual's record, and notify the designated service authorization contractor. The service authorization contractor shall process the decrease request and the waiver individual shall be notified of the change by letter. This letter shall clearly state the waiver individual's right to appeal this change.

2. If a change in the waiver individual's condition necessitates an increase in care, the participating provider shall assess the need for the increase and collaborate with the waiver individual and family, caregiver, or EOR, and MCO care coordinator as appropriate, to develop a POC for services to meet the changed needs. The provider may implement the increase in personal care hours prior to approval from DMAS, or the designated service authorization contractor, if the amount of services does not exceed the total amount established by DMAS as the maximum for the level of care designated for that individual on the plan of care.

3. Any increase to a waiver individual's POC that exceeds the number of hours allowed for that individual's level of care or any change in the waiver individual's level of care shall be authorized by DMAS or the designated service authorization contractor prior to the increase and be accompanied by adequate documentation justifying the increase.

4. In an emergency situation when the health, safety, or welfare of the waiver individual or provider personnel is endangered, the provider shall notify DMAS, or the designated service authorization contractor in writing prior to discontinuing services. The provider shall give written notification to the waiver individual discontinuing services. An advance written notification period shall not be required. If appropriate, local department of social services adult or child protective services shall be notified immediately.

5. In a nonemergency situation, when neither the health, safety, nor welfare of the waiver individual or provider personnel is endangered, the participating provider shall give the waiver individual at least 10 calendar days' written notification (plus three days for mail transit for a total of 13 calendar days from the letter's date) of the intent to discontinue services. The notification letter shall provide the reasons for and the effective date the provider will be discontinuing services.

J. Staff education and training requirements.

1. RNs shall (i) be currently licensed to practice in the Commonwealth as an RN, or shall hold multi-state licensure privilege pursuant to Chapter 30 (§ 54.1-3000 et seq.) of Title 54.1 of the Code of Virginia; (ii) have at least one year of related clinical nursing experience, which may include work in an acute care hospital, public health clinic, home health agency, rehabilitation hospital, or nursing facility, specialized care nursing facility, or long-stay hospital or as an LPN who worked for at least one year in one of these settings; and (iii) meet the requirements of subdivision A 19 of this section regarding criminal record checks and consent to a search of the VDSS Child Protective Services Central Registry if the waiver individual is a minor child. The RN shall not be compensated for services provided to the waiver individual if this record check verifies that the RN has been convicted of a barrier crime described in § 32.1-162.9:1 of the Code of Virginia or if the RN has a founded complaint confirmed by the VDSS Child Protective Services Central Registry.

2. LPNs shall work under supervision as set out in 18VAC90-19-70. LPNs shall (i) be currently licensed to practice in the Commonwealth as an LPN, or shall hold multi-state licensure privilege pursuant to Chapter 30 (§ 54.1-3000 et seq.) of Title 54.1 of the Code of Virginia; (ii) have at least one year of related clinical nursing experience, which may include work in an acute care hospital, public health clinic, home health agency, rehabilitation hospital, NF, specialized care NF, or long-stay hospital. The LPN shall meet the qualifications and skills, prior to being assigned to care for the waiver individual, that are required by the individual's POC; and (iii) meet the requirements of subdivision A 19 of this section regarding criminal record checks and consent to a search of the VDSS Child Protective Services Central Registry if the waiver individual is a minor child. The LPN shall not be compensated for services provided to the waiver individual if this record check verifies that the LPN has been convicted of a barrier crime described in § 32.1-162.9:1 of the Code of Virginia or if the LPN has a founded complaint confirmed by the VDSS Child Protective Services Central Registry.

3. All RNs and LPNs who provide PDN services shall have either (i) at least six months of related clinical experience as documented in their work history, which may include work in acute care hospitals, long-stay hospitals, rehabilitation hospitals, or specialized care nursing facilities, or (ii) completed a provider training program related to the care and technology needs of the assigned waiver individual.

a. Training programs established by providers shall include, at a minimum, the following:

(1) Trainers (either RNs or respiratory therapists) shall have at least six months hands-on successful experience in the areas in which the trainer provides training, such as ventilators, tracheostomies, peg tubes, and nasogastric tubes.

(2) Training shall include classroom time as well as direct hands-on demonstration of mastery by the trainee of the specialized skills required to work with individuals who have technology dependencies.

(3) The training program shall include the following subject areas as they relate to the care to be provided by the nurse: (i) human anatomy and physiology, (ii) medications frequently used by technology dependent individuals, (iii) emergency management, and (iv) the operation of the relevant equipment.

(4) Providers shall ensure a nurse's competency and mastery of the skills necessary to care successfully for a waiver individual prior to assignment. Documentation of successful completion of such training course and mastery of the specialized skills required to work with individuals who have technology dependencies shall be maintained in the provider's personnel records. This documentation shall be provided to DMAS upon request.

b. The RN supervisor for nurses providing PDN shall be currently licensed to practice nursing in the Commonwealth and have at least one year of related clinical nursing experience, which may include work in an acute care hospital, long-stay hospital, rehabilitation hospital, or specialized care nursing facility.

4. Personal care aides who are employed by personal care agencies that are licensed by VDH shall meet the requirements of 12VAC5-381. In addition, personal care aides shall also receive annually a minimum of 12 documented hours of agency-provided training in the performance of these services.

5. Personal care aides who are employed by personal care agencies that are not licensed by VDH shall have completed an educational curriculum of at least 40 hours of study related to the needs of individuals who are either elderly or who have disabilities, as ensured by the provider prior to being assigned to the care of an individual, and shall have the required skills and training to perform the services as specified in the waiver individual's POC and related supporting documentation.

a. Personal care aides' required initial (that is, at the onset of employment) training shall be met in one of the following ways: (i) registration with the Board of Nursing as a certified nurse aide; (ii) graduation from an approved educational curriculum as listed by the Board of Nursing; or (iii) completion of the provider's educational curriculum, which must be a minimum of 40 hours in duration, as taught by an RN who meets the same requirements as the RN listed in subdivision 1 of this subsection.

b. In addition, personal care aides shall also be required to receive annually a minimum of 12 documented hours of agency-provided training in the performance of these services, which shall be documented in the aide's record.

6. Personal care aides shall:

a. Be at least 18 years of age or older;

b. Be able to read and write English to the degree necessary to perform the expected tasks and create and maintain the required documentation;

c. Be physically able to perform the required tasks and have the required skills to perform services as specified in the waiver individual's supporting documentation;

d. Have a valid social security number that has been issued to the personal care aide by the Social Security Administration;

e. Meet the requirements of subdivision A 19 of this section regarding criminal record checks and, if the waiver individual is a minor, consent to a search of the VDSS Child Protective Services Central Registry.

f. Understand and agree to comply with the DMAS CCC Plus Waiver requirements; and

g. Receive tuberculosis (TB) screening as specified in the criteria used by VDH.

7. Consumer-directed personal care attendants shall:

a. Be 18 years of age or older;

b. Be able to read and write in English to the degree necessary to perform the tasks expected and create and maintain the required documentation;

c. Be physically able to perform the required tasks and have the required skills to perform consumer-directed services as specified in the waiver individual's supporting documentation;

d. Have a valid social security number that has been issued to the personal care attendant by the Social Security Administration;

e. Meet the requirements of subdivision A 19 of this section and, if the waiver individual is a minor, consent to a search of the VDSS Child Protective Services Central Registry;

f. Understand and agree to comply with the DMAS CCC Plus Waiver requirements;

g. Receive tuberculosis (TB) screening as specified in the criteria used by VDH; and

h. Be willing to attend training at the request of the individual, family, caregiver, or EOR.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 10, eff. February 22, 2006; amended, Virginia Register Volume 31, Issue 10, eff. February 12, 2015; Volume 40, Issue 20, eff. June 19, 2024; Errata, 40:22 VA.R. 1892 June 17, 2024.

12VAC30-120-935 Participation standards for specific covered services

A. The personal care providers, respite care providers, ADHC providers, private duty nursing providers, and services facilitators shall develop an individualized POC that addresses the waiver individual's service needs. Such plan shall be developed in collaboration with the waiver individual or the individual's family, caregiver, or EOR, as appropriate.

B. DMAS shall not reimburse for any waiver services rendered to waiver individuals when either (i) the spouse of the waiver individual or (ii) the natural, adoptive, step, or foster parent or other legal guardian of the minor child waiver individual is the one providing the service.

1. Payment shall not be made for personal care or respite services furnished by other family members living under the same roof as the waiver individual unless there is objective written documentation as to why no other person or provider is available to render the service. The nurse supervisor or services facilitator shall initially make the determination and document it fully in the individual's record.

2. Payment shall not be made for AT, EM, transition services, or services facilitation services furnished by other family members living under the same roof as the waiver individual receiving services.

3. Payment shall not be made for PDN services furnished by other family members, legal guardians of the waiver individual, or other persons living under the same roof as the waiver individual receiving the service.

4. Family members who are approved to be reimbursed for providing personal care or respite care services shall meet the same qualifications as all other personal care aides or CD attendants.

5. Payment shall not be made for respite care services if the primary caregiver, as identified in the records, receives payment for providing personal care services to the individual. Providers shall document the primary caregiver and whether the caregiver is paid or unpaid in the individual's record prior to requesting respite care service authorization.

C. Agency providers shall employ appropriately licensed professional staff who can provide the covered waiver services required by the waiver individual. Providers shall require that the supervising RN or LPN be available by phone at all times that the LPN or aide is providing services to the waiver individual.

D. Agency staff (RNs, LPNs, or aides) or CD attendants shall only be reimbursed by DMAS for services if they are physically present with the waiver individual and are awake to perform the services outlined in the individual's plan of care.

E. A single agency-directed aide, consumer-directed attendant, RN, or LPN who provides personal care or respite services shall be reimbursed at a maximum limit of 16 hours per day for services rendered to an individual in order to ensure the health and safety of the individual receiving these services.

F. Failure to provide the required services, conduct the required reviews, and meet the documentation standards as stated in this section shall result in audited providers returning overpayments to DMAS.

G. In addition to meeting the general conditions and requirements, home and community-based services participating providers shall also meet the following requirements:

1. ADHC services provider. In order to provide home and community-based services, adult day health center (ADHC) shall:

a. Hold a license with VDSS for adult day care center (ADCC) and make available a copy of the current VDSS license for DMAS review and verification prior to the provider applicant's enrollment as a Medicaid provider;

b. Meet and maintain compliance with provisions of home and community-based rules as detailed in the provider agreement and as described in 42 CFR 441.301; and

c. Employ the following:

(1) A director who shall be responsible for overall management of the center's programs and employees pursuant to 22VAC40-61-130. The director shall be the provider's contact person for DMAS and the designated service authorization contractor and shall be responsible for responding to communication from DMAS and the designated service authorization contractor. The director shall be responsible for ensuring the development of the POCs for waiver individuals. The director shall assign a staff member to act as the ADHC coordinator for each waiver individual and shall document the identity of the ADHC coordinator in each individual's record. The ADHC coordinator can be the director, the activities director, RN, or therapist. The ADHC coordinator shall be responsible for management of the waiver individual's POC and for its review with the program aides and any other staff, as necessary.

(2) An RN who shall be responsible for administering to and monitoring the health needs of waiver individuals. The RN may also contract with the center. The RN shall be responsible for the planning and implementation of the POC involving multiple services where specialized health care knowledge may be needed. The RN shall be present a minimum of eight hours each month at the center. DMAS may require the RN's presence at the center for more than this minimum standard depending on the number of waiver individuals who are in attendance and according to the medical and nursing needs of the waiver individuals who attend the center. Although DMAS does not require that the RN be a full-time staff position, there shall be an RN available, either in person or by telephone, to the center's waiver individuals and staff during all times that the center is in operation. The RN shall be responsible for:

(a) Providing periodic evaluation of the nursing needs of each waiver individual at least every 90 days or sooner when there is a change in the individual's ADHC level of care needs;

(b) Providing the nursing care and treatment as documented in the waiver individual's POC; and

(c) Monitoring, recording, and administering of prescribed medications or supervising the waiver individual in self-administered medication.

(3) Personal care aides who shall be responsible for overall care of waiver individuals such as assistance with ADLs, social or recreational activities, and other health and therapeutic-related activities. Each program aide hired by the provider shall be screened to ensure compliance with training and skill mastery qualifications required by DMAS. The aide shall, at a minimum, have the following qualifications:

(a) Be 18 years of age or older;

(b) Be able to read and write in English to the degree necessary to perform the tasks expected and create and maintain the required waiver individual documentation of services rendered;

(c) Be physically able to perform the work and have the skills required to perform the tasks required in the waiver individual's POC;

(d) Have a valid social security number issued to the program aide by the Social Security Administration;

(e) Have satisfactorily completed an educational curriculum as set out in this subdivision. Documentation of successful completion shall be maintained in the aide's personnel file and be available for review by DMAS staff. Prior to assigning a program aide to a waiver individual, the center shall ensure that the aide has either (i) registered with the Board of Nursing as a certified nurse aide; (ii) graduated from an approved educational curriculum as listed by the Board of Nursing; or (iii) completed the provider's educational curriculum, at least 40 hours in duration, as taught by an RN who is licensed in the Commonwealth or who holds a multi-state licensing privilege.

(4) An activities director who shall be responsible for directing recreational and social activities for the ADHC recipients. The director, at a minimum, shall have the following qualifications:

(a) A minimum of 48 semester hours or 72 quarter hours of post-secondary education from an accredited college or university with a degree in recreational therapy, occupational therapy, or a related field such as art, music, or physical education, and

(b) Have one year of related experience, which may include work in an acute care hospital, rehabilitation hospital, or nursing home, or have completed a course of study including the prescribed internship in occupation, physical, or recreational therapy or music, dance, art therapy, or physical education.

(5) The ADHC coordinator who shall coordinate, pursuant to 22VAC40-61-280, the delivery of the activities and services as prescribed in the waiver individual's POC and keep such plans updated, record 30-day progress notes concerning each waiver individual, and review the waiver individual's daily records each week. If a waiver individual's condition changes more frequently, more frequent reviews and recording of progress notes shall be required to reflect the individual's changing condition. Copied or re-dated notes are not acceptable.

d. Recreation and social activities responsibilities. The center shall provide planned recreational and social activities suited to the waiver individual's needs and interests and designed to encourage physical exercise, prevent deterioration of each waiver individual's condition, and stimulate social interaction.

e. The ADHC shall allow the care coordinator, DMAS, or the managed care organization to meet with waiver individuals to complete the annual individual experience survey, as required in the provisions of 42 CFR 441.301.

f. The center shall maintain all records of each Medicaid individual. These records shall be reviewed periodically by DMAS staff or its designated agent who is authorized by DMAS to review these files. At a minimum, these records shall contain:

(1) DMAS required forms as specified in the center's provider-appropriate guidance documents;

(2) Interdisciplinary POCs developed, in collaboration with the waiver individual, family, or caregiver, or both as may be appropriate, by the center's director, RN, and therapist, as may be appropriate, and any other relevant support persons;

(3) Documentation of interdisciplinary staff meetings that shall be held at least every three months to reassess each waiver individual, evaluate the adequacy of the POC, and make any necessary revisions;

(4) At a minimum, 30-day goal-oriented progress notes recorded by the designated ADHC coordinator. If a waiver individual's condition and treatment POC changes more often, progress notes shall be written more frequently than every 30 days (copied or re-dated notes are not acceptable);

(5) The daily record of services provided shall contain the specific services delivered by center staff. The record shall also contain the arrival and departure times of the waiver individual and shall be signed weekly by either the director, activities director, RN, or therapist employed by the center. The record shall be completed on a daily basis, neither before nor after the date of services delivery. At least once a week, a staff member shall chart significant comments regarding care given to the waiver individual. If the staff member writing comments is different from the staff signing the weekly record, that staff member shall sign the weekly comments. A copy of this record shall be given weekly to the waiver individual, family, or caregiver, and it shall also be maintained in the waiver individual's medical record; and

(6) All contacts shall be documented in the waiver individual's medical record, including correspondence made to and from the individual with family, caregivers, physicians, DMAS, the designated service authorization contractor, formal and informal services providers, and all other professionals related to the waiver individual's Medicaid services or medical care.

2. Agency-directed personal care services. The personal care provider agency shall hire or contract with and directly supervise an RN who provides ongoing supervision of all personal care aides and LPNs. LPNs may supervise, pursuant to their licenses, personal care aides based upon RN assessment of the waiver individual's health, safety, and welfare needs.

a. The RN supervisor shall make an initial home assessment visit on or before the start of care for all individuals admitted to personal care, when a waiver individual is readmitted after being discharged from services, or if the individual is transferred from another provider, ADHC, or other waiver service.

b. Within 30 days after the initial home assessment visit, the RN supervisor shall visit the individual and the individual's family or caregiver, as appropriate, to monitor the plan of care, to reassess the individual's needs, and to determine if the services rendered are adequate to ensure the health, safety, and welfare of the individual.

c. During a home visit, the RN supervisor shall evaluate, at least every 90 days, the LPN supervisor's performance and the waiver individual's needs to ensure the LPN supervisor's abilities to function competently and shall provide training as necessary. This shall be documented in the waiver individual's record. A reassessment of the individual's needs and review of the POC shall be performed and documented during these visits.

d. The nurse supervisor shall also make supervisory visits based on the assessment and evaluation of the care needs of waiver individuals as often as needed and as defined in this subdivision to ensure both quality and appropriateness of services.

(1) The personal care provider agency shall have the responsibility of determining when supervisory visits are appropriate for the waiver individual's health, safety, and welfare. Supervisory visits shall be at least every 90 days. This determination must be documented in the waiver individual's record by the RN on the initial assessment and in the ongoing assessment records.

(2) If DMAS determines that the waiver individual's health, safety, or welfare is in jeopardy, DMAS may require the provider's nurse supervisor to supervise the personal care aides more frequently than once every 90 days. These visits shall be conducted at this designated increased frequency until DMAS determines that the waiver individual's health, safety, or welfare is no longer in jeopardy. This shall be documented by the provider and entered into the individual's record.

(3) During visits to the waiver individual's home, the nurse supervisor shall observe, evaluate, and document the adequacy and appropriateness of personal care services with regard to the individual's current functioning status, medical needs, and social needs. The nurse supervisor shall review the record of the aide or LPN and discuss with the individual, family, or caregiver the satisfaction with the type and amount of services.

(4) If the nurse supervisor must be delayed in conducting the regular supervisory visit, such delay shall be documented in the waiver individual's record with the reasons for the delay. Such supervisory visits shall be conducted within 15 calendar days of the waiver individual's first availability.

(5) A nurse supervisor shall be available to the personal care aide for conferences pertaining to waiver individuals being served by the aide.

(a) The nurse supervisor shall be available to the aide by telephone at all times that the aide is providing services to waiver individuals.

(b) The nurse supervisor shall evaluate the personal care aide's performance and the waiver individual's needs to identify any insufficiencies in the personal care aide's abilities to function competently and shall provide training as indicated. This shall be documented in the waiver individual's record.

(6) Licensed practical nurses (LPNs). As permitted by the license, the LPN may supervise personal care aides. To ensure both quality and appropriateness of services, the LPN supervisor shall make supervisory visits of the aides as often as needed, but no fewer visits than provided in a waiver individual's POC as developed by the RN in collaboration with the individual and the individual's family or caregivers, or both, as appropriate.

(a) During visits to the waiver individual's home, an LPN-supervisor shall observe, evaluate, and document the adequacy and appropriateness of personal care services, the individual's current functioning status, medical needs and social needs. The personal care aide's record shall be reviewed and the waiver individual's, family's, or caregiver's, satisfaction with the type and amount of services discussed.

(b) The LPN supervisor shall evaluate the personal care aide's performance and the waiver individual's needs to identify any insufficiencies in the aide's abilities to function competently and shall provide training as required to resolve the insufficiencies. This shall be documented in the waiver individual's record and reported to the RN supervisor.

(c) An LPN supervisor shall be available to personal care aides for conferences pertaining to waiver individuals being served by them.

(7) Personal care aides. The agency provider may employ and the nurse supervisor shall directly supervise personal care aides who provide direct care to waiver individuals. Each aide hired to provide personal care shall be evaluated by the provider to ensure compliance with qualifications and skills required by DMAS pursuant to 12VAC30-120-930.

e. Required documentation for a waiver individual's records. The provider shall maintain all records for each individual receiving personal care services. These records shall be separate from those of non-home and community-based waiver services, such as companion or home health services. These records shall be reviewed periodically by DMAS or its designated agent. At a minimum, the record shall contain:

(1) All personal care aides' records (DMAS-90) to include (i) the specific services delivered to the waiver individual by the aide; (ii) the personal care aide's actual daily arrival and departure times; (iii) the aide's weekly comments or observations about the waiver individual, including observations of the individual's physical and emotional condition, daily activities, and responses to services rendered; and (iv) any other information appropriate and relevant to the waiver individual's care and need for services.

(2) The personal care aide's and individual's or responsible caregiver's signatures, including the date, shall be recorded on these records verifying that personal care services have been rendered during the week of the service delivery.

(a) An employee of the provider shall not sign for the waiver individual unless that employee is a family member or unpaid caregiver of the waiver individual.

(b) Signatures, times, and dates shall not be placed on the personal care aide record earlier than the last day of the week in which services were provided no more than seven calendar days from the date of the last service.

3. Agency-directed respite care services.

a. To be approved as a respite care provider with DMAS, the respite care agency provider shall:

(1) Employ or contract with and directly supervise either an RN or LPN, or both, who will provide ongoing supervision of all respite care aides or LPNs, as appropriate. An RN shall provide supervision to all direct care and supervisory LPNs.

(a) When respite care services are received on a routine basis, the minimum acceptable frequency of the required nurse supervisor's visits shall not exceed every 90 days, based on the initial assessment. If a waiver individual is also receiving personal care or private duty nursing services, the respite care nurse supervisory visit may coincide with the personal care nurse supervisory visits. However, the nurse supervisor shall document supervision of respite care separately from the personal care documentation. For this purpose, the same individual record may be used with a separate section for respite care documentation.

(b) When respite care services are not received on a routine basis but are episodic in nature, a nurse supervisor shall conduct the home supervisory visit with the aide or LPN on or before the start of care. The RN or LPN shall review the utilization of respite services either every six months or upon the use of half of the approved respite hours, whichever comes first. If a waiver individual is also receiving personal care services from the same provider, the respite care nurse supervisory visit may coincide with the personal care nurse supervisory visit.

(c) During visits to the waiver individual's home, the nurse supervisor shall observe, evaluate, and document the adequacy and appropriateness of respite care services to the waiver individual's current functioning status, medical needs, and social needs. The nurse supervisor shall review the record of the aide or LPN and discuss with the individual, family, or caregiver the satisfaction with the type and amount of services.

(d) Should the required nurse supervisory visit be delayed, the reason for the delay shall be documented in the waiver individual's record. This visit shall be completed within 15 days of the waiver individual's first availability.

(2) Employ or contract with aides to provide respite care services who shall meet the same education and training requirements as personal care aides.

(3) Employ an LPN or RN to perform skilled respite care services when skilled respite services are offered. Such services shall be reimbursed by DMAS under the following circumstances:

(a) The waiver individual shall have a documented need for routine skilled respite care that cannot be provided by unlicensed personnel, such as an aide. These waiver individuals would typically require a skilled level of care involving, for example but not necessarily limited to, ventilators for assistance with breathing or either nasogastric or gastrostomy feedings;

(b) No other person in the waiver individual's support system is willing and able to supply the skilled component of the individual's care during the unpaid primary caregiver's absence; and

(c) The waiver individual is unable to receive skilled nursing visits from any other source that could provide the skilled care usually given by the unpaid primary caregiver.

(4) Document in the waiver individual's record the circumstances that require the provision of skilled respite services by an LPN or RN. At the time of the LPN's or RN's service, the LPN or RN shall also provide all of the skilled respite services normally provided by an aide.

b. Required documentation for a waiver individual's records. The provider shall maintain all records for each waiver individual receiving respite services. These records shall be clearly labeled and maintained separately from those of non-home and community-based waiver services, such as companion or home health services. These records shall be reviewed periodically either by the DMAS staff or a contracted entity who is authorized by DMAS to review these records. At a minimum these records shall contain:

(1) Forms as specified in the DMAS guidance documents.

(2) All respite care LPN, RN, or aide records shall contain:

(a) The specific services delivered to the waiver individual by the LPN, RN, or aide;

(b) The respite care LPN's, RN's, or aide's daily arrival and departure times;

(c) Comments or observations recorded weekly about the waiver individual. LPN, RN, or aide comments shall include observation of the waiver individual's physical, medical, and emotional condition, daily activities, the individual's response to services rendered, and documentation of vital signs if taken as part of the POC.

(3) Skilled respite care LPN or RN records, which may be documented on the DMAS 90-A, shall be reviewed and signed by the supervising RN and shall contain:

(a) The signatures of the skilled respite care LPN or RN and waiver individual or responsible family or caregiver, including the date, verifying that skilled respite care services have been rendered during the week of service delivery as documented in the record.

(b) An employee of the provider shall not sign for the waiver individual unless the employee is a family member or unpaid caregiver of the waiver individual.

(c) Signatures, times, and dates shall not be placed on the skilled respite care LPN or aide record earlier than the last day of the week in which services were provided. Nor shall signatures be placed on the respite care LPN or aide records later than seven calendar days from the date of the last service.

4. Consumer-directed (CD) services facilitation for personal care and respite services.

a. Any services rendered by attendants prior to dates authorized by DMAS or the service authorization contractor shall not be eligible for Medicaid reimbursement and shall be the responsibility of the waiver individual.

b. If the services facilitator is not an RN, then the services facilitator shall inform the primary health care provider for the individual that services are being provided within 30 days from the start of such services and request consultation with the primary health care provider, as needed. This shall be done after the services facilitator secures written permission from the individual to contact the primary health care provider. The documentation of this written permission to contact the primary health care provider shall be retained in the individual's medical record. All contacts with the primary health care provider shall be documented in the individual's medical record.

c. The services facilitator or any staff or volunteer of the services facilitator providing direct service to Medicaid individuals shall meet the following qualifications:

(1) To be enrolled as a Medicaid services facilitator and maintain provider status, the services facilitator shall have sufficient knowledge, skills, and abilities to perform the activities required of such providers. In addition, the services facilitator shall have the ability to maintain and retain business and professional records sufficient to fully and accurately document the nature, scope, and details of the services provided.

(2) Effective January 11, 2016, all services facilitators and volunteers providing direct service to Medicaid individuals shall:

(a) Have a satisfactory work record as evidenced by at least two references from prior job experience with no evidence of abuse, neglect, or exploitation of incapacitated or older adults or children. In instances of employees who have worked for only one employer, such employees shall be permitted to provide one appropriate employment reference and one appropriate personal reference, including no evidence of abuse, neglect, or exploitation of incapacitated or older adults or children.

(b) Within 30 calendar days of employment, the services facilitator, staff, or volunteer shall obtain an original criminal record clearance with respect to convictions for offenses specified in § 19.2-392.02 of the Code of Virginia or an original criminal history record from the Central Criminal Records Exchange. The staff or volunteer shall also submit to a screening through the VDSS Child Protective Services (CPS) Central Registry if serving a waiver individual who is a minor child. Provider staff and volunteers shall not be reimbursed for services provided to the waiver individual effective on the date and thereafter that the VDSS CPS Central Registry check confirms the provider's staff person or volunteer has a finding.

(i) DMAS shall not reimburse a provider for services provided by a staff or volunteer who works in a position that involves direct contact with a waiver individual until an original criminal record clearance or original criminal history record has been received. DMAS shall reimburse services provided by such a staff person during only the first 30 calendar days of employment if the provider can produce documented evidence that such person worked only under the direct supervision of another staff person for whom a background check was completed in accordance with the requirements of this section. If an original criminal record clearance or original criminal history record is not received within the first 30 calendar days of employment, DMAS shall not reimburse the provider for services provided by such staff or volunteer on the 31st calendar day through the date on which the provider receives an original criminal record clearance or an original criminal history record.

(ii) DMAS shall not reimburse a provider for services provided by a staff or volunteer who has been convicted of any offense set forth in clause (i) of the definition of barrier crime in § 19.2-392.02 of the Code of Virginia unless all of the following conditions are met: (i) the offense was punishable as a misdemeanor; (ii) the staff or volunteer has been convicted of only one such offense; (iii) the offense did not involve abuse or neglect; and (iv) at least five years have elapsed since the conviction.

(c) The staff or volunteer shall provide the hiring entity with a sworn statement or affirmation disclosing any criminal convictions or any pending criminal charges, whether within or outside of the Commonwealth.

(d) Not be debarred, suspended, or otherwise excluded from participating in federal health care programs, as listed on the federal List of Excluded Individuals/Entities (LEIE) database at https://www.oig.hhs.gov.

(3) Effective January 11, 2016, all services facilitators shall possess the required degree and experience, as follows:

(a) Prior to initial enrollment by DMAS as a services facilitator or being hired by a Medicaid-enrolled services facilitator provider, all new applicants shall possess, at a minimum, either (i) an associate's degree from an accredited college in a health or human services field or be a registered nurse currently licensed to practice in the Commonwealth and possess a minimum of two years of satisfactory direct care experience supporting individuals with disabilities or older adults; or (ii) a bachelor's degree in a non-health or human services field and possess a minimum of three years of satisfactory direct care experience supporting individuals with disabilities or older adults.

(b) Persons who are services facilitators prior to January 11, 2016, shall not be required to meet the degree and experience requirements of subdivision 4 c (3) (a) of this subsection unless required to submit a new application to be a services facilitator after January 11, 2016.

(4) Effective April 10, 2016, all services facilitators shall complete required training and competency assessments. Satisfactory competency assessment results shall be kept in the service facilitator's record. All new services facilitators shall complete training and pass the corresponding competency assessment with a score of at least 80% in order to begin and to continue being reimbursed for or working with waiver individuals for the purpose of reimbursement for services through this waiver.

(5) As a component of the renewal of the Medicaid provider agreement, all services facilitators shall pass the competency assessment every five years and achieve a score of at least 80%.

(6) The services facilitator shall have access to a computer with Internet access that meets the security standards of Subpart C of 45 CFR Part 164 for the electronic exchange of information. Electronic exchange of information shall include, for example, checking individual eligibility, submission of service authorizations, submission of information to the fiscal employer agent, and billing for services.

(7) The services facilitator must possess a combination of work experience and relevant education that indicates possession of the following knowledge, skills, and abilities. Such knowledge, skills, and abilities must be documented on the services facilitator's application form, found in supporting documentation, or be observed during a job interview. Observations during the interview must be documented. The knowledge, skills, and abilities include:

(a) Knowledge of:

(i) Types of functional limitations and health problems that may occur in individuals with disabilities or older adults, as well as strategies to reduce limitations and health problems;

(ii) Physical care that may be required by individuals with disabilities or older adults, such as transferring, bathing techniques, bowel and bladder care, and the approximate time those activities normally take;

(iii) Equipment and environmental modifications that may be required by individuals with disabilities or older adults that reduce the need for human help and improve safety;

(iv) Various long-term care program requirements, including institutional and assisted living facility placement criteria, Medicaid waiver services, and other federal, state, and local resources that provide personal care and respite services;

(v) CCC Plus Waiver requirements, as well as the administrative duties for which the services facilitator will be responsible;

(vi) How to conduct assessments (including environmental, psychosocial, health, and functional factors) and their uses in services planning;

(vii) Interviewing techniques;

(viii) The individual's right to make decisions about, direct the provisions of, and control one's own consumer-directed services, including hiring, training, managing, approving the work shift entries of, and firing of an attendant;

(ix) The principles of human behavior and interpersonal relationships; and

(x) General principles of record documentation.

(b) Skills in:

(i) Negotiating with individuals, family, caregivers, and service providers;

(ii) Assessing, supporting, observing, recording, and reporting behaviors;

(iii) Identifying, developing, or providing services to individuals with disabilities or older adults; and

(iv) Identifying services within the established services system to meet the individual's needs.

(c) Abilities to:

(i) Report findings of the assessment or onsite visit, either in writing or an alternative format for individuals who have visual or hearing impairments;

(ii) Demonstrate a positive regard for individuals and their families;

(iii) Be persistent and remain objective;

(iv) Work independently, performing job position duties under general supervision;

(v) Communicate effectively orally and in writing; and

(vi) Develop a rapport and communicate with individuals from diverse cultural backgrounds.

(8). Failure to satisfy the competency assessment requirements and meet all other requirements shall result in a retraction of Medicaid payment or the termination of the provider agreement, or both.

d. Initiation of services and service monitoring.

(1) Upon entry into consumer-directed services, the services facilitator shall make an initial comprehensive home visit at the primary residence of the individual to collaborate with the individual or the individual's family or caregiver, as appropriate, to identify the individual's needs, assist in the development of the plan of care with the waiver individual and individual's family or caregiver, as appropriate, and provide EOR management training within seven days of the initial visit. The initial comprehensive home visit shall be conducted only once upon the individual's entry into consumer-directed services. The individual shall receive one comprehensive visit per lifetime. If the individual changes service facilitators, the new services facilitator shall complete a reassessment visit in lieu of a comprehensive visit. The EOR management training shall be limited to one visit per EOR.

(2) Within 30 days after the initial comprehensive visit, the services facilitator shall visit the individual and the individual's family or caregiver, as appropriate, to monitor the plan of care, to reassess the individual's needs, and to determine if the services rendered are adequate to ensure the health, safety, and welfare of the individual. During this visit, the services facilitator, individual, EOR, and family or caregiver, as appropriate, shall agree to the frequency of routine visits, which shall be conducted at least every 90 days but no more frequently than every 30 days. The agreement shall be documented in the service facilitator's records.

(3) During the routine visit, the services facilitator shall continue to monitor the plan of care on an as-needed basis and shall conduct face-to-face meetings with the individual and may include the EOR, family, or caregiver. Such visits shall be documented in the individual's medical record.

(4) When respite is the sole service provided, the services facilitator shall review the utilization of consumer-directed respite services, either every six months or upon the use of half of the approved respite services hours, whichever comes first, and shall conduct a face-to-face meeting with the individual and may include the family or caregiver, as appropriate. Such visits shall be documented in the individual's record.

(5) Every six months, the services facilitator shall conduct a face-to-face reassessment visit with the individual and EOR, family, or caregiver, as appropriate. During the visit, the services facilitator shall review the individual's current functional and support status, review all services the individual receives, including the existing plan of care, discuss the individual's and EOR's satisfaction with services, update the plan of care as necessary, and submit new service authorization requests for personal care hours and other waiver services if necessary. The services facilitator shall not conduct a routine visit and reassessment visit during the same visit but shall submit reimbursement for only a reassessment visit.

(6) During all visits with the individual, the services facilitator shall observe, evaluate, and consult with the individual or EOR and may include the family or caregiver to document the adequacy and appropriateness of consumer-directed services with regard to the individual's current functioning, cognitive status, and medical and social needs. The services facilitator's written summary of the visit shall include at a minimum:

(a) Discussion with the waiver individual, family, caregiver, or EOR, as appropriate, concerning whether the service is adequate to meet the waiver individual's needs;

(b) Any suspected abuse, neglect, or exploitation and to whom it was reported;

(c) Any special tasks performed by the consumer-directed attendant and the consumer-directed attendant's qualifications to perform these tasks;

(d) The individual's, family's, caregiver's, or EOR's satisfaction with the service;

(e) Any hospitalization or change in medical condition, functioning, or cognitive status;

(f) The presence or absence of the attendant during the services facilitator's visit; and

(g) The appropriateness of the EOR to fulfill the responsibilities of the role.

(7) The services facilitator shall provide follow-up management training to the individual or EOR, as appropriate, under the following circumstances:

(a) The training shall be requested by the individual or EOR. Training shall not be provided at the request of the services facilitator, family, caregiver, or attendant;

(b) The training shall be limited to the role and responsibilities of the EOR. Training shall not include duties that are to be performed by the attendant;

(c) The training shall be provided in a face-to-face visit; and

(d) The services facilitator shall utilize the management training service to reimburse for tuberculosis screening, cardiopulmonary resuscitation training, and influenza immunization for the attendant at the request of the EOR. Requests for reimbursement shall be limited to the exact cost of the activity. Documentation of the cost and receipt of such activities shall be maintained in the individual's record.

e. DMAS, its designated contractor, or the fiscal/employer agent shall request a criminal record check and a check of the VDSS Child Protective Services Central Registry if the waiver individual is a minor child, in accordance with 12VAC30-120-930, pertaining to the consumer-directed attendant on behalf of the waiver individual and report findings of these records checks to the EOR.

f. The services facilitator shall review and verify copies of work shift entries to ensure that the hours approved in the plan of care are being provided and are not exceeded. If discrepancies are identified, the services facilitator shall discuss these with the individual or EOR to resolve discrepancies and shall notify the fiscal/employer agent. The services facilitator shall also review the individual's plan of care to ensure that the individual's needs are being met. Failure to conduct such reviews and verifications of work shift entries and maintain the documentation of these reviews shall result in a recovery by DMAS of payments made in accordance with 12VAC30-80-130.

g. The services facilitator shall maintain records of each individual served. At a minimum, these records shall contain:

(1) Results of the initial comprehensive home visit completed prior to or on the date services are initiated and subsequent reassessments and changes to the supporting documentation;

(2) The personal care plan of care. Such plans shall be reviewed by the provider every 90 days, annually, and more often as needed, and modified as appropriate. The respite services plan of care shall be included in the record and shall be reviewed by the provider every six monthsor when half of the approved respite service hours have been used whichever comes first. For the annual review and in cases where either the personal care or respite care plan of care is modified, the plan of care shall be reviewed with the individual, the family or caregiver, and EOR, as appropriate;

(3) The services facilitator's dated notes documenting any contacts with the individual, family, caregiver, or EOR and visits to the individual (copied or re-dated notes are not acceptable);

(4) All contacts, including correspondence, made to and from the individual, EOR, family or caregiver, physicians, DMAS, the designated service authorization contractor, MCO, formal and informal services provider, and all other professionals related to the individual's Medicaid services or medical care;

(5) All employer management training provided to the individual or EOR to include, for example, (i) receipt of training on the individual's or EOR's responsibilities for the accuracy of the consumer-directed attendant's work shift entries and (ii) the availability of the Consumer-Directed Employer of Record Manual available at http://dmas.virginia.gov;

(6) All documents signed by the individual or EOR, as appropriate, that acknowledge the responsibilities as the employer; and

(7) The DMAS required forms as specified in the DMAS Commonwealth Coordinated Care Plus Waiver Manual.

Failure to maintain all required documentation shall result in action by DMAS to recover payments made in accordance with 12VAC30-80-130. Repeated instances of failure to maintain documentation may result in cancellation of the Medicaid provider agreement.

h. In instances when the individual is consistently unable either to hire or retain the employment of a personal care attendant to provide consumer-directed personal care or respite services such as, for example, a pattern of discrepancies with the attendant's work shift entries, the services facilitator shall make arrangements, after conferring with DMAS or the managed care organization, to have the needed services transferred to an agency-directed services provider of the individual's choice or discuss with the individual, family, caregiver, or EOR other service options.

i. Waiver individual, family or caregiver, and EOR responsibilities.

(1) The individual shall be authorized for the consumer-directed model of service, and the EOR shall successfully complete EOR management training performed by the services facilitator before the individual or EOR shall be permitted to hire a consumer-directed attendant for Medicaid reimbursement. Any service that may be rendered by a consumer-directed attendant prior to authorization by Medicaid shall not be eligible for reimbursement by Medicaid. Individuals who are eligible for consumer-directed services shall have the capability to hire and train their own consumer-directed attendants and supervise the consumer-directed attendants' performances. In lieu of handling their consumer-directed attendants themselves, individuals may have a family or caregiver, or other designated person serve as the EOR on their behalf. The EOR shall be prohibited from also being the Medicaid-reimbursed consumer-directed attendant for respite or personal care or the services facilitator for the individual.

(2) Individuals shall acknowledge that consumer-directed personal care services shall not continue when the service is no longer appropriate or necessary for the individual's care needs and that the individual shall inform the services facilitator of a change in care needs. If the consumer-directed model of services continues after services have been terminated by DMAS or the designated service authorization contractor, the individual shall be held liable for the consumer-directed attendant compensation.

(3) Individuals shall notify the services facilitator of all hospitalizations or admissions, for example, any rehabilitation hospital, rehabilitation hospital unit, nursing facility, specialized care nursing facility, or long-stay hospital as consumer-directed attendant services shall not be reimbursed during such admissions. Failure to do so may result in the individual being held liable for the consumer-directed employee compensation.

5. Personal emergency response systems.In addition to meeting the general conditions and requirements for home and community-based waiver services participating providers as specified in 12VAC30-120-930, PERS providers must also meet the following qualifications and requirements:

a. A PERS provider shall be a personal care agency, a durable medical equipment provider, a licensed home health provider, or a PERS manufacturer. All such providers shall have the ability to provide PERS equipment, direct services (i.e., installation, equipment maintenance, and service calls), and PERS monitoring;

b. The PERS provider shall provide an emergency response center with fully trained operators who are capable of (i) receiving signals for help from an individual's PERS equipment 24 hours a day, 365 or 366 days per year, as appropriate; (ii) determining whether an emergency exists; and (iii) notifying an emergency response organization or an emergency responder that the PERS individual needs emergency help;

c. A PERS provider shall comply with all applicable Virginia statutes, all applicable regulations of DMAS, and all other governmental agencies having jurisdiction over the services to be performed;

d. The PERS provider shall have the primary responsibility to furnish, install, maintain, test, and service the PERS equipment, as required, to keep it fully operational. The provider shall replace or repair the PERS device within 24 hours of the waiver individual's notification of a malfunction of the console unit, activating devices, or medication monitoring unit and shall provide temporary equipment, as may be necessary for the waiver individual's health, safety, and welfare, while the original equipment is being repaired or replaced;

e. The PERS provider shall install, consistent with the manufacturer's instructions, all PERS equipment into a waiver individual's functioning telephone line or system within seven days of the request of such installation unless there is appropriate documentation of why this timeframe cannot be met. The PERS provider shall furnish all supplies necessary to ensure that the system is installed and working properly. The PERS provider shall test the PERS device monthly, or more frequently if needed, to ensure that the device is fully operational;

f. The PERS installation shall include local seize line circuitry, which guarantees that the unit shall have priority over the telephone connected to the console unit should the telephone be off the hook or in use when the unit is activated;

g. A PERS provider shall maintain a data record for each waiver individual at no additional cost to DMAS or the waiver individual. The record shall document all of the following:

(1) Delivery date and installation date of the PERS equipment;

(2) Waiver individual or caregiver signature verifying receipt of the PERS equipment;

(3) Verification by a monthly test that the PERS device is operational;

(4) The waiver individual's contact information, to be updated annually or more frequently as needed, as provided by the individual or the individual's caregiver or EOR;

(5) A case log documenting the waiver individual's utilization of the system, all contacts, and all communications with the individual, caregiver or EOR, and responders;

(6) Documentation that the waiver individual is able to use the PERS equipment through return demonstration; and

(7) Copies of all equipment checks performed on the PERS unit;

h. The PERS provider shall have backup monitoring capacity in case the primary system cannot handle incoming emergency signals;

i. The emergency response activator shall be capable of being activated either by breath, touch, or some other means and shall be usable by waiver individuals who are visually or hearing impaired or physically disabled. The emergency response communicator shall be capable of operating without external power during a power failure at the waiver individual's home for a minimum period of 24 hours. The emergency response console unit shall also be able to self-disconnect and redial the backup monitoring site without the waiver individual resetting the system in the event it cannot get its signal accepted at the response center;

j. PERS providers shall be capable of continuously monitoring and responding to emergencies under all conditions, including power failures and mechanical malfunctions. It shall be the PERS provider's responsibility to ensure that the monitoring agency and the monitoring agency's equipment meet the following requirements. The PERS provider shall be capable of simultaneously responding to multiple signals for help from the waiver individuals' PERS equipment. The PERS provider's equipment shall include the following:

(1) A primary receiver and a backup receiver, which shall be independent and interchangeable;

(2) A backup information retrieval system;

(3) A clock printer, which shall print out the time and date of the emergency signal, the waiver individual's identification code, and the emergency code that indicates whether the signal is active, passive, or a responder test;

(4) A backup power supply;

(5) A separate telephone service;

(6) A toll-free number to be used by the PERS equipment in order to contact the primary or backup response center; and

(7) A telephone line monitor, which shall give visual and audible signals when the incoming telephone line is disconnected for more than 10 seconds;

k. The PERS provider shall maintain detailed technical and operation manuals that describe PERS elements, including the installation, functioning, and testing of PERS equipment; emergency response protocols; and recordkeeping and reporting procedures;

l. The PERS provider shall document and furnish within 30 days of the action taken, a written report for each emergency signal that results in action being taken on behalf of the waiver individual. This excludes test signals or activations made in error. This written report shall be furnished to (i) the personal care provider; (ii) the respite care provider; (iii) the services facilitation provider; (iv) in cases where the individual only receives ADHC services, to the ADCC provider; or (v) to the transition coordinator for the service in which the individual is enrolled; and

m. The PERS provider shall obtain and keep on file a copy of the most recently completed DMAS-225 form. Until the PERS provider obtains a copy of the DMAS-225 form, the PERS provider shall clearly document efforts to obtain the completed DMAS-225 form from the personal care provider, respite care provider, services facilitation provider, or ADCC provider.

6. Assistive technology (AT) and environmental modification (EM) services. AT and EM shall be provided only to waiver individuals by providers who have current provider participation agreements with DMAS.

a. AT shall be rendered by providers having a current provider participation agreement with DMAS as durable medical equipment and supply providers. An independent, professional consultation shall be obtained, as may be required, from qualified professionals who are knowledgeable of that item for each AT request prior to approval by either DMAS or the service authorization contractor and may include training on such AT by the qualified professional. Independent, professional consultants shall include speech or language therapists, physical therapists, occupational therapists, physicians, behavioral therapists, certified rehabilitation specialists, or rehabilitation engineers. Providers that supply AT for a waiver individual may not perform assessment or consultation, write specifications, or inspect the AT for that individual. AT shall be delivered within 60 days from the start date of the authorization. The AT provider shall ensure that the AT functions properly.

b. In addition to meeting the general conditions and requirements for home and community-based waiver services participating providers as specified in 12VAC30-120-930, as appropriate, environmental modifications shall be provided in accordance with all applicable state or local building codes by contractors who have provider agreements with DMAS. Modifications shall be completed within a year of the start date of the authorization.

c. Providers of AT and EM services shall not be permitted to recover equipment that has been provided to waiver individuals whenever the provider has been charged, by either DMAS or its designated service authorization agent, with overpayments and is therefore being required to return payments to DMAS.

d. Providers of AT and EM services shall maintain in each individual's record all supporting documentation of the costs and estimates of the service. Should there be a change in the cost of the service, the new cost and estimate documentation shall also be included along with justification of the change in cost.

7. Transition services. This service shall be provided consistent with Part XX (12VAC30-120-2000 et seq.) of 12VAC30-120.

8. Private duty nursing (PDN).

a. This service shall be provided through a home health agency licensed or certified by VDH for Medicaid participation and with which DMAS has a contract for either PDN or congregate PDN or both.

b. The provider shall operate from a business office.

c. The provider shall employ (or subcontract with) and directly supervise an RN or an LPN. The LPN and RN shall be currently licensed to practice in the Commonwealth. Prior to providing PDN services, the RN or LPN shall have either (i) at least six months of related clinical nursing experience or (ii) completed a provider training program related to the care and technology needs of the waiver individual as described in 12VAC30-120-930 J 3. Regardless of whether a nurse has six months of experience or completes a provider training course, the provider agency shall be responsible for assuring all nurses who are assigned to an individual are competent in the care needs of that individual.

d. As part of direct supervision, the RN supervisor shall make, at a minimum, a visit every 30 days to ensure both quality and appropriateness of PDN to assess the individual's and the family's or caregiver's satisfaction with the services being provided, to review the medication and treatments, and to update and verify that the most current physician signed orders are in the home record.

(1) The waiver individual shall be present when the supervisory visits are made;

(2) At least every other visit shall be in the individual's primary residence;

(3) When a delay occurs in the RN supervisor's visits because the individual is unavailable, the reason for the delay shall be documented in the individual's record, and the visit shall occur as soon as the individual is available. Failure to meet this standard may result in a DMAS recovery of payments made; and

(4) Additional supervisory visits may be required under the following circumstances: (i) at the provider's discretion; (ii) at the request of the individual; (iii) when a change in the individual's condition has occurred; (iv) any time the health, safety, or welfare of the individual could be at risk; and (v) at the request of the DMAS staff.

e. When skilled respite services are routine in nature and offered in conjunction with personal care (PC) services for adults, the RN supervisory visit conducted for personal care may serve as the supervisory visit for respite services. However, the supervisor shall document supervision of skilled respite services separately. For this purpose, the same individual record can be used with a separate section clearly labeled for documentation of skilled respite services.

f. For DMAS-enrolled PDN providers that also provide PC services, the provider shall employ or subcontract with and directly supervise an RN who will provide ongoing supervision of all personal care aides. The supervising RN shall be currently licensed to practice nursing in the Commonwealth and have at least one year of related clinical nursing experience, which may include work in an acute care hospital, long-stay hospital, rehabilitation hospital, nursing facility, or specialized care nursing facility. In addition to meeting the general conditions and requirements for home and community-based waiver services participating providers as specified in 12VAC30-120-930 and this section for PDN, providers shall also comply with the requirements of this section in the provision of PC services.

g. The following documentation shall be maintained for every individual for whom DMAS-enrolled providers render these services:

(1) Physicians' orders for these services shall be maintained in the individual's record as well as at the individual's primary residence. All recertifications of the POC shall be performed within the last five business days of each current 60-day period. The physician shall sign the recertification before Medicaid reimbursement shall occur;

(2) All assessments, reassessments, and evaluations (including the complete LTSS screening packet or risk evaluations) made during the provision of services, including any required initial assessments by the RN supervisor completed prior to or on the date services are initiated and changes to the supporting documentation by the RN supervisor;

(3) Progress notes reflecting the individual's status and, as appropriate, progress toward the identified goals in the POC (copied or re-dated notes are not acceptable);

(4) All related communication with the individual and the individual's representative, the DMAS-designated agent for service authorization, consultants, DMAS, VDSS, formal and informal service providers, all required referrals, as appropriate, to adult protective services or child protective services and all other professionals concerning the individual;

(5) All service authorization decisions rendered by the DMAS staff or the DMAS-designated service authorization contractor;

(6) All POCs completed with the individual, family, or caregiver, as appropriate, and specific to the service being provided and all supporting documentation related to any changes in the POC; and

(7) Notes of any verbal or nonverbal cues, motions, signals, or actions the individual makes to indicate distress or uses to call in case of an emergency. The individual, primary caregiver, or family, as appropriate, shall share this information with the RN or LPN at the onset of services. Documentation of these cues shall be kept in the individual's record and shall be reviewed periodically to ensure the individual is still able to perform these cues.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 31, Issue 10, eff. February 12, 2015; amended, Virginia Register Volume 35, Issue 2, eff. October 27, 2018; Errata 35:3 VA.R. 502 October 1, 2018; amended, Virginia Register Volume 40, Issue 20, eff. June 19, 2024.

12VAC30-120-940 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 22, Issue 10, eff. February 22, 2006; repealed, Virginia Register Volume 31, Issue 10, eff. February 12, 2015.

12VAC30-120-945 Payment for covered services

A. DMAS shall not reimburse providers, either agency-directed or consumer-directed, for any staff training required by these waiver regulations or any other training that may be required.

B. All services provided in the CCC Plus Waiver shall be reimbursed at a rate established by DMAS in its agency fee schedule.

1. DMAS or its contractor shall reimburse a per diem fee for ADHC services that shall be considered as payment in full for all services rendered to that waiver individual as part of the individual's approved ADHC plan of care.

2. Personal care (agency-directed and consumer-directed), respite (agency-directed and consumer-directed), and PDN care services shall be reimbursed on an hourly basis consistent with the agency's fee schedule. Effective July 1, 2021, a single consumer-directed attendant who provides personal care or respite services shall be reimbursed at the regular rate for up to 40 hours per week for authorized services rendered and at one and a half times the regular rate for up to 16 hours per week beyond 40 hours. This shall not apply to consumer-directed attendants who are exempt from overtime requirements under 29 USC § 552.102 of the federal Fair Labor Standards Act, 29 USC § 201 et seq.

3. Transition services. The total costs of these transition services shall be limited to $5,000 per waiver individual per lifetime and shall be expended within nine months from the start date of authorization. Transition services shall be reimbursed at the actual cost of the item; no mark ups shall be permitted.

4. Reimbursement for assistive technology (AT) and environmental modification (EM) services shall be as follows:

a. All AT services provided in the CCC Plus Waiver shall be reimbursed as a service limit of one and up to a per member annual maximum of $5,000 per calendar year regardless of waiver. These limits shall apply regardless of whether the waiver individual remains in this waiver or changes to another waiver program. AT services shall be reimbursed in a manner that is reasonable and customary not to exceed the provider's usual and customary charges to the general public. No markups shall be permitted.

b. All EM services provided in the CCC Plus Waiver shall be reimbursed as a service limit of one and up to a per member annual maximum of $5,000 per calendar year regardless of waiver. These limits shall apply regardless of whether the individual remains in this waiver or changes to another waiver program. All EM services shall be reimbursed at the actual cost of material and labor and no mark ups shall be permitted.

5. PERS monthly fee payments shall be consistent with the agency's fee schedule.

C. Duplication of services.

1. DMAS shall not duplicate services that are required as a reasonable accommodation as a part of the American with Disabilities Act (42 USC §§ 12131 through 12165), the Rehabilitation Act of 1973 (29 USC § 794), or the Virginians with Disabilities Act (§ 51.5-1 et seq. of the Code of Virginia).

2. Payment for waiver services shall not duplicate payments made to public agencies or private entities under other program authorities for this same purpose. All private insurance benefits for these waiver-covered services shall be exhausted before Medicaid reimbursement can occur as Medicaid shall be the payer of last resort.

3. DMAS payments for EM services shall not be duplicative in homes where multiple waiver individuals reside.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 31, Issue 10, eff. February 12, 2015; amended, Virginia Register Volume 40, Issue 20, eff. June 19, 2024.

12VAC30-120-950 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 22, Issue 10, eff. February 22, 2006; repealed, Virginia Register Volume 31, Issue 10, eff. February 12, 2015.

12VAC30-120-960 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 22, Issue 10, eff. February 22, 2006; repealed, Virginia Register Volume 31, Issue 10, eff. February 12, 2015.

12VAC30-120-970 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 22, Issue 10, eff. February 22, 2006; amended, Virginia Register Volume 25, Issue 20, eff. July 9, 2009; repealed, Virginia Register Volume 31, Issue 10, eff. February 12, 2015.

12VAC30-120-980 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 22, Issue 10, eff. February 22, 2006; repealed, Virginia Register Volume 31, Issue 10, eff. February 12, 2015.

12VAC30-120-990 Quality management review; utilization review; level of care (LOC) reviews

A. DMAS shall perform quality management reviews for the purpose of assuring high quality of service delivery consistent with the attending physicians' orders, approved POCs, service authorized services for the waiver individuals, and DMAS compliance with CMS assurances. Providers identified as not meeting the standards consistent with such orders, POCs, and service authorizations shall be required to submit corrective action plans (CAPs) to DMAS for approval. Once approved, such CAPs shall be implemented to resolve the cited deficiencies.

B. If DMAS staff determines, during any review or at any other time, that the waiver individual no longer meets the criteria for participation in the waiver (such as functional dependencies, medical/nursing needs, risk of NF placement, or Medicaid financial eligibility), then DMAS staff, as appropriate, shall deny payment for waiver services for such waiver individual and the waiver individual shall be discharged from the waiver.

C. Securing service authorization shall not necessarily guarantee reimbursement pursuant to DMAS utilization review of waiver services.

D. Failure to meet documentation requirements and supervisory reviews in a timely manner may result in either a plan of corrective action or retraction of payments.

E. Once waiver enrollment occurs, Level of Care Eligibility Re-determination audits (LOCERI) shall be performed at DMAS.

1. This independent electronic calculation of eligibility determination is performed and communicated to the DMAS supervisor. Any individual whose LOCERI audit shows failure to meet eligibility criteria shall receive a second manual review and may receive a home visit by DMAS staff.

2. The agency provider and the CD services facilitator shall submit to DMAS upon request an updated DMAS-99 LOC form, information from a current DMAS-97 A/B form, and, if applicable, the DMAS-225 form for designated waiver individuals. This information is required by DMAS to assess the waiver individual's ongoing need for Medicaid-funded long-term care and appropriateness and adequacy of services rendered.

F. DMAS or its designated agent shall periodically review and audit providers' records for these services for conformance to regulations and policies and concurrence with claims that have been submitted for payment. When a waiver individual is receiving multiple services, the records for all services shall be separated from those of non-home and community-based care services, such as companion or home health services. Failure to maintain the required documentation may result in DMAS' determination of overpayments against providers and requiring such providers to repay these overpayments pursuant to § 32.1-325.1 of the Code of Virginia.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 31, Issue 10, eff. February 12, 2015.

12VAC30-120-995 Appeals

A. Providers shall have the right to appeal actions taken by DMAS. Provider appeals shall be considered pursuant to § 32.1-325.1 of the Code of Virginia and the Virginia Administrative Process Act (§ 2.2-4000 et seq.) of the Code of Virginia and DMAS regulations at 12VAC30-10-1000 and Part XI (12VAC30-20-500 et seq.) of 12VAC30-20.

B. Individuals shall have the right to appeal actions taken by DMAS. Individuals' appeals shall be considered pursuant to 12VAC30-110-10 through 12VAC30-110-370. DMAS shall provide the opportunity for a fair hearing, consistent with 42 CFR Part 431, Subpart E.

C. The individual shall be advised in writing of such denial and of his right to appeal consistent with DMAS client appeals regulations 12VAC30-110-70 and 12VAC30-110-80.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 31, Issue 10, eff. February 12, 2015.

Part X Intellectual Disability Waiver

12VAC30-120-1000 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 29, Issue 20, eff. July 4, 2013; amended, Virginia Register Volume 32, Issue 20, eff. June 29, 2016; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-1005 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 29, Issue 20, eff. July 4, 2013; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-1010 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 29, Issue 20, eff. July 4, 2013; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-1012 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 32, Issue 20, eff. June 29, 2016; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-1020 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 29, Issue 20, eff. July 4, 2013; amended, Virginia Register Volume 30, Issue 7, eff. January 2, 2014; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-1030 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 29, Issue 20, eff. July 4, 2013; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-1040 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 29, Issue 20, eff. July 4, 2013; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-1060 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 29, Issue 20, eff. July 4, 2013; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-1062 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 32, Issue 20, eff. June 29, 2016; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-1070 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 29, Issue 20, eff. July 4, 2013; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-1072 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 32, Issue 20, eff. June 29, 2016; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-1080 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 29, Issue 20, eff. July 4, 2013; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-1082 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 32, Issue 20, eff. June 29, 2016; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-1088 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 29, Issue 20, eff. July 4, 2013; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-1090 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 29, Issue 20, eff. July 4, 2013; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

Part XV Day Support Waiver for Individuals with Mental Retardation

12VAC30-120-1500 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. December 26, 2007; amended, Virginia Register Volume 25, Issue 20, eff. July 9, 2009; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-1510 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. December 26, 2007; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-1520 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. December 26, 2007; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-1530 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. December 26, 2007; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-1540 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. December 26, 2007; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC30-120-1550 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 24, Issue 6, eff. December 26, 2007; amended, Virginia Register Volume 25, Issue 20, eff. July 9, 2009; repealed, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

Part XVI Alzheimer's Waiver

12VAC30-120-1600 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 23, Issue 20, eff. July 11, 2007; amended, Virginia Register Volume 28, Issue 20, eff. July 5, 2012; Volume 31, Issue 25, eff. September 9, 2015; repealed, Virginia Register Volume 38, Issue 11, eff. March 3, 2022.

12VAC30-120-1605 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 28, Issue 20, eff. July 5, 2012; repealed, Virginia Register Volume 38, Issue 11, eff. March 3, 2022.

12VAC30-120-1610 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 23, Issue 20, eff. July 11, 2007; amended, Virginia Register Volume 28, Issue 20, eff. July 5, 2012; Volume 31, Issue 25, eff. September 9, 2015; repealed, Virginia Register Volume 38, Issue 11, eff. March 3, 2022.

12VAC30-120-1620 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 23, Issue 20, eff. July 11, 2007; amended, Virginia Register Volume 28, Issue 20, eff. July 5, 2012; repealed, Virginia Register Volume 38, Issue 11, eff. March 3, 2022.

12VAC30-120-1630 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 23, Issue 20, eff. July 11, 2007; amended, Virginia Register Volume 28, Issue 20, eff. July 5, 2012; repealed, Virginia Register Volume 38, Issue 11, eff. March 3, 2022.

12VAC30-120-1640 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 23, Issue 20, eff. July 11, 2007; amended, Virginia Register Volume 28, Issue 20, eff. July 5, 2012; repealed, Virginia Register Volume 38, Issue 11, eff. March 3, 2022.

12VAC30-120-1650 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 23, Issue 20, eff. July 11, 2007; amended, Virginia Register Volume 28, Issue 20, eff. July 5, 2012; repealed, Virginia Register Volume 38, Issue 11, eff. March 3, 2022.

12VAC30-120-1660 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 23, Issue 20, eff. July 11, 2007; amended, Virginia Register Volume 28, Issue 20, eff. July 5, 2012; repealed, Virginia Register Volume 38, Issue 11, eff. March 3, 2022.

12VAC30-120-1670 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 28, Issue 20, eff. July 5, 2012; repealed, Virginia Register Volume 38, Issue 11, eff. March 3, 2022.

12VAC30-120-1680 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 28, Issue 20, eff. July 5, 2012; repealed, Virginia Register Volume 38, Issue 11, eff. March 3, 2022.

Part XVII Home and Community-Based Services for Technology Assisted Individuals Waiver [Repealed]

12VAC30-120-1700 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 30, Issue 12, eff. March 13, 2014; repealed, Virginia Register Volume 40, Issue 20, eff. June 19, 2024.

12VAC30-120-1705 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 30, Issue 12, eff. March 13, 2014; repealed, Virginia Register Volume 40, Issue 20, eff. June 19, 2024.

12VAC30-120-1710 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 30, Issue 12, eff. March 13, 2014; amended, Virginia Register Volume 33, Issue 25, eff. September 6, 2017; repealed, Virginia Register Volume 40, Issue 20, eff. June 19, 2024.

12VAC30-120-1720 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 30, Issue 12, eff. March 13, 2014; amended, Virginia Register Volume 33, Issue 25, eff. September 6, 2017; repealed, Virginia Register Volume 40, Issue 20, eff. June 19, 2024.

12VAC30-120-1730 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 30, Issue 12, eff. March 13, 2014; amended, Virginia Register Volume 33, Issue 25, eff. September 6, 2017; repealed, Virginia Register Volume 40, Issue 20, eff. June 19, 2024.

12VAC30-120-1740 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 30, Issue 12, eff. March 13, 2014; amended, Virginia Register Volume 33, Issue 25, eff. September 6, 2017; repealed, Virginia Register Volume 40, Issue 20, eff. June 19, 2024.

12VAC30-120-1750 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 30, Issue 12, eff. March 13, 2014; repealed, Virginia Register Volume 40, Issue 20, eff. June 19, 2024.

12VAC30-120-1760 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 30, Issue 12, eff. March 13, 2014; repealed, Virginia Register Volume 40, Issue 20, eff. June 19, 2024.

12VAC30-120-1770 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 30, Issue 12, eff. March 13, 2014; repealed, Virginia Register Volume 40, Issue 20, eff. June 19, 2024.

Part XX Money Follows the Person

12VAC30-120-2000 Transition coordinator

A. Service description.

1. Transition coordination means the DMAS-enrolled provider who is responsible for supporting the individual and family/caregiver, as appropriate, with the activities associated with transitioning from an institution to the community pursuant to the Elderly or Disabled with Consumer Direction waiver.

2. Transition coordination services include, but are not limited to, the development of a transition plan; the provision of information about services that may be needed, in accordance with the timeframe specified by federal law, prior to the discharge date, during and after transition; the coordination of community-based services with the case manager if case management is available; linkage to services needed prior to transition such as housing, peer counseling, budget management training, and transportation; and the provision of ongoing support for up to 12 months after discharge date.

B. Criteria.

1. In order to qualify for these services, the individual shall have a demonstrated need for transition coordination of any of these services. Documented need shall indicate that the service plan cannot be implemented effectively and efficiently without such coordination from this service. Transition coordination services must be prior authorized by DMAS or its designated agent.

2. The individual's service plan shall clearly reflect the individual's needs for transition coordination provided to the individual, family/caregivers, and providers in order to implement the service plan effectively. The service plan includes, at a minimum: (i) a summary or reference to the assessment; (ii) goals and measurable objectives for addressing each identified need; (iii) the services, supports, and frequency of service to accomplish the goals and objectives; (iv) target dates for accomplishment of goals and objectives; (v) estimated duration of service; (vi) the role of other agencies if the plan is a shared responsibility; and (vii) the staff responsible for coordination and integration of services, including the staff of other agencies if the plan is a shared responsibility.

C. Service units and limitations. The unit of service shall be specified by the DMAS fee schedule. The services shall be explicitly detailed in the supporting documentation. Travel time is an in-kind expense within this service and is not billable as a separate item. Transition coordination may not be billed solely for purposes of monitoring. Transition coordination shall be available to individuals who are transitioning from institutional care to the community. Transition coordination service providers shall be reimbursed according to the amount and type of service authorized in the service plan based on a monthly fee for service.

D. Provider requirements. In addition to meeting the general conditions and requirements for home and community-based care participating providers as specified in 12VAC30-120-730 and 12VAC30-120-740, transition coordinators shall meet the following qualifications:

1. Transition coordinators shall be employed by one of the following: a local government agency; a private, nonprofit organization qualified under 26 USC § 501(c)(3); or a fiscal management service with experience in providing this service.

2. A qualified transition coordinator shall possess, at a minimum, a bachelor's degree in human services or health care and relevant experience that indicates the individual possesses the following knowledge, skills, and abilities. These shall be documented on the transition coordinator's job application form or supporting documentation, or observable in the job or promotion interview. The transition coordinator shall be at least 21 years of age.

3. Transition coordinators shall have knowledge of (i) aging, independent living, the impact of disabilities, and transition planning; (ii) individual assessments, including psychosocial, health, and functional factors, and their uses in service planning, (iii) interviewing techniques, (iv) individuals' rights, (v) local human and health service delivery systems, including support services and public benefits eligibility requirements, (vi) principles of human behavior and interpersonal relationships, (vii) interpersonal communication principles and techniques, (viii) general principles of file documentation, and (ix) the service planning process and the major components of a service plan.

4. Transition coordinators shall have skills in negotiating with individuals and service providers; observing, and reporting behaviors; identifying and documenting an individual's needs for resources, services and other assistance; identifying services within the established services system to meet the individual's needs; coordinating the provision of services by diverse public and private providers; analyzing and planning for the service needs of the individual; and assessing individuals using DMAS' authorized assessment forms.

5. Transition coordinators shall have the ability to demonstrate a positive regard for individuals and their families or designated guardian; be persistent and remain objective; work as a team member, maintaining effective interagency and intraagency working relationships; work independently, performing position duties under general supervision; communicate effectively, both verbally and in writing; develop a rapport; communicate with different types of persons from diverse cultural backgrounds; and interview.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 20, eff. July 9, 2009; amended, Virginia Register Volume 32, Issue 6, eff. January 1, 2016.

12VAC30-120-2010 Transition services

A. Service description. "Transition services" means set-up expenses for individuals who are transitioning from an institution or licensed or certified provider-operated living arrangement to a living arrangement in a private residence, which may include an adult foster home, where the person is directly responsible for his own living expenses. 12VAC30-120-2000 provides the service description, criteria, service units and limitations, and provider requirements for this service.

The individual's transition from an institution to the community shall have a transition coordinator in order to receive EDCD Waiver services or a case manager or health care coordinator if he shall be receiving services through either the IFDDS, ID, or Technology Assisted Waivers.

B. Criteria for receipt of services. In order to be provided, transition services shall be prior authorized by DMAS or its designated agent. These services include rent or utility deposits, basic furniture and appliances, health and safety assurances, and other reasonable expenses incurred as part of a transition. For the purposes of transition services, an institution means an ICF/IID, a nursing facility, or a specialized care facility/hospital as defined at 42 CFR 435.1009. Transition services do not apply to an acute care admission to a hospital.

C. Service units and limitations.

1. Services are available for one transition per individual and must be expended within nine months from the date of authorization. The total cost of these services shall not exceed $5,000, per person lifetime limit coverage of transition costs to residents of nursing facilities, specialized care facility/hospitals, or ICF/IID, who are Medicaid recipients and are able to return to the community. The $5,000 maximum allowance must be expended within nine months from the date of authorization for transition services. It shall not be available to the individual after that period of time. The DMAS designated fiscal agent shall manage the accounting of the transition service. The transition coordinator for the EDCD Waiver or the case manager or health care coordinator, as appropriate to the waiver, shall ensure that the funding spent is reasonable and does not exceed the $5,000 maximum limit.

2. Allowable costs include:

a. Security deposits and the first month's rent that are required to obtain a lease on an apartment or home;

b. Essential household furnishings required to occupy and use a community domicile, including furniture, window coverings, food preparation items, and bed/bath linens;

c. Set-up fees or deposits for utility or services access, including telephone, electricity, heating and water;

d. Services necessary for the individual's health, safety, and welfare such as pest eradication and one-time cleaning prior to occupancy;

e. Moving expenses;

f. Fees to obtain a copy of a birth certificate or an identification card or driver's license; and

g. Activities to assess need, arrange for, and procure needed resources.

3. The services are furnished only to the extent that they are reasonable and necessary as determined through the service plan development process, are clearly identified in the service plan and the person is unable to meet such expense, or when the services cannot be obtained from another source.

4. The expenses shall not include ongoing monthly rental or mortgage expenses, food, regular utility charges, or household items that are intended for purely diversional/recreational purposes. This service shall not include services or items that are covered under other waiver services such as chore, homemaker, environmental modifications and adaptations, or specialized supplies and equipment.

D. Provider requirements. Providers must be enrolled as a Medicaid Provider for Transition Coordination or Case Management and work with the DMAS designated agent to receive reimbursement for the purchase of appropriate transition goods or services on behalf of the individual.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 20, eff. July 9, 2009; amended, Virginia Register Volume 32, Issue 6, eff. January 1, 2016.

Chapter 130 Amount, Duration and Scope of Selected Services

Part I Outpatient Physical Rehabilitative Services (Repealed)

12VAC30-130-10 (Repealed.)

History

• Historical Notes: Derived from VR460-04-3.1300 § 1.1, eff. June 29, 1994; amended, Virginia Register Volume 11, Issue 17, eff. July 1, 1995; Volume 26, Issue 21, eff. July 21, 2010; repealed, Virginia Register Volume 32, Issue 6, eff. January 1, 2016.

12VAC30-130-15 (Repealed.)

History

• Historical Notes: Derived from VR460-04-3.1300 § 2.1; Virginia Register Volume 11, Issue 17, eff. July 1, 1995; repealed, Virginia Register Volume 32, Issue 6, eff. January 1, 2016.

12VAC30-130-20 (Repealed.)

History

• Historical Notes: Derived from VR460-04-3.1300 § 2, eff. June 29, 1994; amended, Virginia Register Volume 11, Issue 17, eff. July 1, 1995; Volume 18, Issue 10, eff. February 27, 2002; Volume 26, Issue 21, eff. July 21, 2010; repealed, Virginia Register Volume 32, Issue 6, eff. January 1, 2016.

12VAC30-130-30 (Repealed.)

History

• Historical Notes: Derived from VR460-04-3.1300 § 3.2, eff. June 29, 1994; amended, Virginia Register Volume 11, Issue 17, eff. July 1, 1995; Volume 26, Issue 21, eff. July 21, 2010; repealed, Virginia Register Volume 32, Issue 6, eff. January 1, 2016.

12VAC30-130-40 (Repealed.)

History

• Historical Notes: Derived from VR460-04-3.1300 § 3.3, eff. June 29, 1994; amended, Virginia Register Volume 11, Issue 17, eff. July 1, 1995; Volume 26, Issue 21, eff. July 21, 2010; repealed, Virginia Register Volume 32, Issue 6, eff. January 1, 2016.

12VAC30-130-42 (Repealed.)

History

• Historical Notes: Derived from VR460-04-3.1300 § 4.1; Virginia Register Volume 11, Issue 17, eff. July 1, 1995; repealed, Virginia Register Volume 32, Issue 6, eff. January 1, 2016.

12VAC30-130-50 (Repealed.)

History

• Historical Notes: Derived from VR460-04-3.1300 § 5, eff. June 29, 1994; amended, Virginia Register Volume 11, Issue 17, eff. July 1, 1995; Volume 19, Issue 18, eff. July 1, 2003; repealed, Virginia Register Volume 32, Issue 6, eff. January 1, 2016.

12VAC30-130-60 (Repealed.)

History

• Historical Notes: Derived from VR460-04-3.1300 § 6, eff. June 29, 1994; amended, Virginia Register Volume 11, Issue 17, eff. July 1, 1995; repealed, Virginia Register Volume 32, Issue 6, eff. January 1, 2016.

12VAC30-130-70 (Repealed.)

Historical Notes

Derived from VR460-04-3.1300 § 7, eff. June 29, 1994; repealed, Virginia Register Volume 11, Issue 17, eff. July 1, 1995.

Part II Long-Stay Acute Care Hospitals

12VAC30-130-80 Scope

Medicaid shall cover long-stay acute care hospital services as defined in 12VAC30-130-90 provided by hospitals certified as long-stay acute care hospitals and which have provider agreements with the Department of Medical Assistance Services.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.10 § 1, eff. June 29, 1994.

12VAC30-130-90 Authorization for services

Long-stay acute care hospital stays shall be preauthorized by the submission of a completed comprehensive assessment instrument, a physician certification of the need for long-stay acute care hospital placement, and any additional information that justifies the need for intensive services. Prior authorization shall be required by submission of the information described above. Physician certification must accompany the request. Periods of care not authorized by the Department of Medical Assistance Services shall not be approved for payment.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.10 § 2, eff. June 29, 1994.

12VAC30-130-100 Criteria for long-stay acute care hospital stays

A. Adult long-stay acute care hospital criteria.

1. The resident must have long-term health conditions requiring close medical supervision, 24-hour licensed nursing care, and specialized services or equipment needs. The population to be served includes individuals requiring mechanical ventilation, individuals with communicable diseases requiring universal or respiratory precautions, individuals requiring ongoing intravenous medication or nutrition administration, and individuals requiring comprehensive rehabilitative therapy services.

2. At a minimum, the individual must require physician visits at least once weekly, licensed nursing services 24 hours a day (a registered nurse whose sole responsibility is the designated unit must be on the nursing unit on which the resident resides, 24 hours a day), and coordinated multidisciplinary team approach to meet needs.

3. In addition, the individual must meet at least one of the following requirements:

a. Must require two out of three of the following rehabilitative services: physical therapy, occupational therapy, speech-pathology services; each required therapy must be provided daily, five days per week, for a minimum of one hour each day; individual must demonstrate progress in overall rehabilitative plan of care on a monthly basis; or

b. Must require special equipment such as mechanical ventilators, respiratory therapy equipment (that has to be supervised by a licensed nurse or respiratory therapist), monitoring device (respiratory or cardiac), kinetic therapy; or

c. The individual must require at least one of the following special services:

(1) Ongoing administration of intravenous medications or nutrition (i.e. total parenteral nutrition (TPN), antibiotic therapy, narcotic administration, etc.);

(2) Special infection control precautions such as universal or respiratory precaution (this does not include handwashing precautions only);

(3) Dialysis treatment that is provided on-unit (i.e. peritoneal dialysis);

(4) Daily respiratory therapy treatments that must be provided by a licensed nurse or a respiratory therapist;

(5) Extensive wound care requiring debridement, irrigation, packing, etc., more than two times a day (i.e. grade IV decubiti; large surgical wounds that cannot be closed; second- or third-degree burns covering more than 10% of the body); or

(6) Multiple unstable ostomies (a single ostomy does not constitute a requirement for special care) requiring frequent care (i.e. suctioning every hour, stabilization of feeding, stabilization of elimination, etc.)

B. Pediatric/adolescent patients in long-stay acute care hospitals criteria.

1. To be eligible for long-stay acute care hospital services, the child must have ongoing health conditions requiring close medical supervision, 24-hour licensed nursing supervision, and specialized services or equipment needs. The recipient must be age 21 or under. The population to be served includes children requiring mechanical ventilation, those with communicable diseases requiring universal or respiratory precautions (excluding normal childhood diseases such as chicken pox, measles, strep throat, etc.), those requiring ongoing intravenous medication or nutrition administration, those requiring daily dependence on device-based respiratory or nutritional support (tracheostomy, gastrostomy, etc.), those requiring comprehensive rehabilitative therapy services, and those with a terminal illness.

2. The child must minimally require physician visits at least once weekly, licensed nursing services 24 hours a day (a registered nurse whose sole responsibility is that nursing unit must be on the unit on which the child is residing 24 hours a day), and a coordinated multidisciplinary team approach to meet needs.

3. In addition, the child must meet one of the following requirements:

a. Must require two out of three of the following physical rehabilitative services: physical therapy, occupational therapy, speech-pathology services; each required therapy must be provided daily, five days per week, for a minimum of 45 minutes per day; child must demonstrate progress in overall rehabilitative plan of care on a monthly basis; or

b. Must require special equipment such as mechanical ventilators, respiratory therapy equipment (that has to be supervised by licensed nurse or respiratory therapist), monitoring device (respiratory or cardiac), kinetic therapy, etc; or

c. Must require at least one of the following special services:

(1) Ongoing administration of intravenous medications or nutrition (i.e. total parenteral nutrition (TPN), antibiotic therapy, narcotic administration, etc.);

(2) Special infection control precautions such as universal or respiratory precaution (this does not include handwashing precautions only or isolation for normal childhood diseases such as measles, chicken pox, strep throat, etc.);

(3) Dialysis treatment that is provided within the facility (i.e. peritoneal dialysis);

(4) Daily respiratory therapy treatments that must be provided by a licensed nurse or a respiratory therapist;

(5) Extensive wound care requiring debridement, irrigation, packing, etc., more than two times a day (i.e., grade IV decubiti; large surgical wounds that cannot be closed; second- or third-degree burns covering more than 10% of the body);

(6) Ostomy care requiring services by a licensed nurse;

(7) Services required for terminal care.

4. In addition, the long-stay acute care hospital must provide for the educational and habilitative needs of the child. These services must be age appropriate, must meet state educational requirements, and must be appropriate to the child's cognitive level. Services must also be individualized to meet the specific needs of the child and must be provided in an organized manner that encourages the child to participate. Services may include, but are not limited to, school, active treatment for mental retardation, habilitative therapies, social skills, and leisure activities. Therapeutic leisure activities must be provided daily.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.10 § 3, eff. June 29, 1994.

12VAC30-130-110 Documentation requirements

A. Services not specifically documented in the resident's medical record as having been rendered shall be deemed not to have been rendered and no coverage shall be provided.

B. The long-stay acute care hospital shall maintain and retain the business and professional records sufficient to document fully and accurately the nature, scope, and details of the health care provided. Such records shall be retained for a period of not less than five years from the date of service or as provided by applicable state laws, whichever period is longer, except that, if an audit is initiated within the required retention period, the records must be retained until the audit is completed and every exception resolved.

C. The following documentation must be maintained in the resident's medical record:

1. Each record must identify the resident on each page.

2. Entries must be signed and dated (month, day, and year) by the author, followed by professional title. Care rendered by personnel under the supervision of the provider, which is in accordance with Medicaid policy, must be countersigned by the responsible licensed participating provider.

3. The attending physician must certify at the time of admission that the resident requires long-stay acute hospital care and meets the criteria as defined by DMAS.

4. The record must contain a preliminary working diagnosis and the elements of a history and physical examination upon which the diagnosis is based.

5. All services provided, as well as any treatment plan, must be entered in the record. Any drugs prescribed and administered as part of a physician's treatment plan, including the quantities, route of administration, and the dosage must be recorded.

6. The record must indicate the resident's progress, any change in diagnosis or treatment, and the response to the treatment. The documentation must include in detail all treatment rendered to the resident in accordance with the plan with specific attention to frequency, duration, modality, response to treatment, and identify who provided such treatment.

7. Physician progress notes must be written at least weekly and must reflect that the resident has been examined by the physician.

8. A comprehensive nursing assessment must be made by a registered nurse at the time of admission to the facility. Nursing care plans based on an admission assessment must be resident-specific and must indicate realistic nursing needs, measurable goals, and specifically state the method by which the goals are to be accomplished. They must be updated as needed, but at least monthly. Nursing summaries, in addition to the p.r.n. (as needed) notes, are required weekly. Nursing summaries must give a current, written picture of the resident, the resident's nursing needs, the care being provided, and the resident's response to treatment. The nursing summary at a minimum must address the following: medical status; functional status in activities of daily living, elimination, mobility, and emotional/mental status; special nursing procedures; and identification and resolution of acute illnesses or episodes.

9. Social services documentation must include a social evaluation and history and a social services plan of care including a discharge plan. The social work plans of care must be resident-specific and include measurable goals with realistic time frames. Social work plans of care must be updated as needed and at least monthly every 30 days. Social services progress notes must be written at least every 30 days.

10. Activities documentation must be based on a comprehensive assessment completed by the designated activity coordinator. An activity plan of care must be developed for each resident and must include consideration of the individual's interests and skills, the physician's recommendations, social and rehabilitation goals, and personal care requirements. Individual and group activities must be included in the plan. The activity plan of care must be updated as needed but at least every 30 days. Activity progress notes must be written at least every 30 days. Therapeutic leisure activities must be provided daily.

11. Rehabilitative therapy (physical and occupational therapy or speech-language services) or other health care professional (psychologist, respiratory therapist, etc.) documentation must include an assessment completed by the qualified rehabilitation professional. A plan of care developed specific to the resident must be developed and must include measurable goals with realistic time frames. The plan of care must be updated as needed but at least every 30 days. Rehabilitative therapy or other health care professional progress notes must be written at least every 30 days.

12. Each resident's record must contain a dietary evaluation and plan of care completed by a registered dietician. The plan of care must be resident-specific and must have measurable goals within realistic time frames. The plan of care must be updated as needed, but at least every 30 days. The dietary assessment and monthly plans of care must be completed by a registered dietician. Dietary progress notes must be written at least every 30 days.

13. A coordinated interdisciplinary plan of care must be developed for each resident. The plan of care must be resident-specific and must contain measurable goals within realistic time frames. Based on the physician's plan of care, the interdisciplinary team should include, but is not necessarily limited to, nurses, social workers, activities coordinators, dieticians, rehabilitative therapists, direct care staff, and the resident or responsible party. At a minimum, the interdisciplinary team must review and update the interdisciplinary plan of care as needed but at least every 30 days. The interdisciplinary plan of care review must identify those attending the meeting, changes in goals and approaches, and progress made toward meeting established goals and discharge.

14. For residents age 21 and younger, the record must contain documentation that educational or habilitative services are provided as required. The documentation shall include an evaluation of the resident's educational or habilitative needs, a description of the educational or habilitative services provided, a schedule of planned programs, and records of resident attendance. Educational or habilitative progress notes shall be written at least every 30 days.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.10 § 4, eff. June 29, 1994.

12VAC30-130-120 Long-stay acute care hospital services

All services must be provided by appropriately qualified personnel. The following services are covered long-stay acute care hospital services:

A. Physician services.

1. Physician services shall be performed by a professional who is licensed to practice in the Commonwealth, who is acting within the scope of his license, and who is a doctor of medicine or osteopathy, a doctor of dental surgery or dental medicine, a doctor of podiatric medicine, a doctor of optometry, or a chiropractor.

2. An attending physician means a physician who is a doctor of medicine or osteopathy and is identified by the individual as having the most significant role in the determination and delivery of the individual's medical care.

B. Licensed nursing services.

1. Must be provided 24 hours a day (a registered nurse, whose sole responsibility is the designated unit on which the resident resides, must be on the unit 24 hours a day).

2. Nursing services shall be of a level of complexity and sophistication, or the condition of the resident shall be of a nature, that the services can only be performed by a registered nurse or licensed professional nurse, or nursing assistant under the direct supervision of a registered nurse who is experienced in providing the specialized care required by the resident.

C. Rehabilitative services.

1. Rehabilitative services shall be directly and specifically related to written plan of care designed by a physician after any needed consultation with the rehabilitation professional.

2. Physical therapy services shall be of a level of complexity and sophistication, or the condition of the resident shall be of a nature, that the services can only be performed by a physical therapist licensed by the Board of Medicine, or a physical therapy assistant who is licensed by the Board of Medicine and under the direct supervision of a physical therapist licensed by the Board of Medicine.

3. Occupational therapy services shall be of a level of complexity and sophistication, or the condition of the resident shall be of a nature, that the services can only be performed by an occupational therapist registered and certified by the American Occupational Therapy Certification Board or an occupational therapy assistant certified by the American Occupational Therapy Certification Board under the direct supervision of an occupational therapist as defined.

4. Speech-language services shall be of a level of complexity and sophistication, or the condition of the resident shall be of a nature that the services can only be performed by a speech-language pathologist licensed by the Board of Audiology and Speech-Language Pathology.

D. Ancillary services shall be provided directly and specifically related to a plan of care designed by the physician. The ancillary services may include but are not limited to dietary, respiratory therapy services, and psychological services.

1. Dietary services must be of a level of complexity or sophistication, or the nature of the resident shall be of a nature that the services can only be performed or supervised by a dietician, registered with the American Dietetic Association.

2. Respiratory therapy services must be of a level of complexity and sophistication, or the nature of the resident shall be of a nature that the services can only be performed by a respiratory therapist. Respiratory therapy services must be provided by a respiratory therapist certified by the Board of Medicine or registered with the National Board for Respiratory Care. If the facility agrees to provide care to a resident who is dependent on mechanical assistance for respiration (positive or negative pressure mechanical ventilators), respiratory therapy services must be available 24 hours daily. If the facility contracts for respiratory therapy services, a respiratory therapist must be on call 24 hours daily and available to the facility in a timely manner.

3. Psychology services shall be of a level of complexity or sophistication, or the condition shall be of a nature that the services can only be performed by a psychologist licensed by the Board of Medicine or by a licensed clinical social worker under the direct supervision of a licensed clinical psychologist or a licensed psychologist clinical.

4. Activity programs under the supervision of designated activities coordinators. The program of activities must include both individual and group activities which are based on consideration of interest, skills, physical and mental status, and personal care requirements.

5. Provide social services to each resident in an effort to assist the resident, his family and the facility staff in understanding the significant social and emotional factors related to the health problems, to assist with appropriate utilization of community resources and to coordinate discharge plans. Social services must be provided by a social worker with at least a bachelor's degree in social work or similar qualifications.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.10 § 5, eff. June 29, 1994.

12VAC30-130-130 Long-stay acute care hospital requirements

A. A coordinated multidisciplinary team approach shall be implemented to meet the needs of the resident. Based on the physician's plan of care, the interdisciplinary team should include, but is not necessarily limited to, nurses, social workers, activity coordinators, dieticians, rehabilitative therapists, and any direct care staff.

B. The long-stay acute care hospital shall provide for the educational and habilitative needs of residents age 21 or younger. These services must be age appropriate, must meet state educational requirements, and must be appropriate to the child's cognitive level. Services must be individualized to meet the specific needs of the child and must be provided in an organized manner which encourages the child to participate. Services may include but are not limited to school, active treatment for mental retardation, habilitative therapies, social skills and leisure activities. Therapeutic leisure activities must be provided daily.

C. The long-stay acute care hospital shall provide an acceptable plan for assuring that residents requiring long-stay acute hospital care are afforded the same opportunity for participating in integrated facility activities as the other facility residents.

D. Nonemergency transportation shall be provided so that residents may participate in community activities sponsored by the facility or community activities in which the facility is providing transportation for other facility residents.

E. The long-stay acute care hospital shall coordinate discharge planning for the resident utilizing all available resources in an effort to assist the resident to maximize his potential for independence and self-sufficiency and to assure that services are being provided by the most effective level of care.

F. The long-stay acute care hospital shall provide family or caregiver training in the skills necessary for the care of the resident in the community, should the resident or the resident's caregiver so desire.

G. The long-stay acute care hospital shall provide all necessary durable medical equipment to sustain life or monitor vital signs and to carry out a plan of care designed by the physician. This equipment may include but is not limited to mechanical ventilator, apnea monitor, etc.

H. The long-stay acute care hospital shall provide utilization review activities as follows:

1. Purpose. The objective of the utilization review mechanism is the maintenance of high-quality patient care and the most efficient utilization of resources through an educational approach involving the study of patient care as well as to ensure that inpatient care is provided only when medically necessary and that the care meets quality standards.

a. In addition to the certification by the resident's physician, the hospital shall have a utilization review plan which provides for review of all Medicaid patient stays and medical care evaluation studies of admissions, durations of stay, and professional services rendered.

b. Effective utilization review shall be maintained on a continuing basis to ensure the medical necessity of the services for which the program pays and to promote the most efficient use of available health facilities and services.

2. The Department of Medical Assistance Services delegates to the local facilities' utilization review departments the utilization review of inpatient hospital services for all Medicaid admissions. The hospital must have a utilization review plan reflecting 100% review of Medicaid residents, approved by the Division of Licensure and Certification of the Department of Health, and DMAS or the appropriate licensing agency in the state in which the institution is licensed.

3. The hospital utilization review coordinator shall approve the medical necessity, based on admission criteria approved by the utilization review committee, within one working day of admission. In the event of an intervening Saturday, Sunday, or holiday, a review must be performed the next working day. This review shall be reflected in the hospital utilization review plan and the resident's record.

4. If the admission is determined medically necessary, an initial stay review date must be assigned and reflected on the utilization review sheets. Continued or extended stay review must be assigned prior to or on the date assigned for the initial stay. If the facility's utilization review committee has reason to believe that an inpatient admission was not medically necessary, it may review the admission at any time. However, the decision of a utilization review committee in one facility shall not be binding upon the utilization review committee in another facility.

5. If the admission or continued stay is found to be medically unnecessary, the attending physician shall be notified and be allowed to present additional information. If the hospital physician advisor still finds the admission or continued stay unnecessary, a notice of adverse decision must be made within one working day after the admission or continued stay is denied. Copies of this decision must be sent by the utilization review committee's designated agent to the hospital administrator, attending physician, recipient or recipient's authorized representative, and Medicaid.

6. As part of the utilization review plan, long-stay acute care hospitals shall have one medical or patient care evaluation study in process and one completed each calendar year. Medical care evaluation studies must contain the elements mandated by 42 CFR 456.141 through 456.145. The elements are objectives of study, results of the study, evaluation of the results, and action plan or recommendations as indicated by study results.

7. The Department of Medical Assistance Services shall monitor the length of stay for inpatient hospital stays. The guidelines used shall be based on the criteria described in 12VAC30-130-100. If the stay or any portion of the stay is found to be medically unnecessary, contrary to program requirements, or if the required documentation has not been received, reimbursement will not be made by Medicaid.

8. Services not specifically documented in the patient's medical record as having been rendered shall be deemed not to have been rendered and no coverage shall be provided.

I. The long-stay acute care hospital shall provide all medical supplies necessary to provide care as directed by the physician's plan of care for the resident. These supplies may include but are not limited to suction catheters, tracheostomy care supplies, oxygen, etc.

J. The long-stay acute care hospital shall provide all nutritional elements including those that must be administered intravenously. This includes providing all necessary equipment or supplies necessary to administer the nutrients.

K. The long-stay acute care hospital shall submit all necessary health care and medical social service information on the resident to DMAS for preadmission authorization. The provider cannot bill DMAS for services that have not been preauthorized.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.10 § 6, eff. June 29, 1994.

Part III Preadmission Screening and Annual Resident Review

12VAC30-130-140 Definitions

"Community Services Board (CSB)" means the local governmental agency responsible for local mental health, mental retardation, and substance abuse services. Boards function as service providers, client advocates, and community educators.

"Dementia" means, for the purposes described herein, having a primary diagnosis of dementia, as described in the Diagnostic and Statistical Manual of Mental Disorders, 3rd edition, revised in 1987, or a nonprimary diagnosis of dementia unless the primary diagnosis is a major mental disorder as defined herein.

"Diagnostic and Statistical Manual of Mental Disorders, 3rd edition" means the 1987 publication of the American Psychiatric Association classifying diagnoses of abnormal behavior.

"Interfacility transfer" means when an individual is transferred from one nursing facility (NF) to another nursing facility, with or without an intervening hospital stay. Interfacility transfers are subject to annual resident review rather than preadmission screening. In cases of transfer of a resident with MI or MR or a related condition (MR/RC) from a NF to a hospital or to another NF, the transferring NF is responsible for ensuring that copies of the resident's most recent preadmission screening and annual resident review (PASARR) and resident assessment reports shall accompany the transferring resident.

"Level I identification" means the process performed to identify nursing facility applicants with a condition of mental illness or mental retardation.

"Level II evaluation" means the evaluation process for nursing facility applicants who are identified as having a condition of mental illness or mental retardation as defined herein. The purpose of the Level II evaluation is to recommend placement of and services to nursing facility applicants with statutorily defined mental illness or mental retardation.

"Mental Illness (MI)" means a serious mental illness meeting all of the following requirements:

1. The individual has a major mental disorder diagnosable under the Diagnostic and Statistical Manual of Mental Disorders, 3rd edition, revised in 1987 that is a schizophrenic, mood, paranoid, panic, or other severe anxiety disorder; somatoform disorder, personality disorder, other psychotic disorder, or another mental disorder that may lead to a chronic disability. The disorder is not a primary diagnosis of dementia, including Alzheimer's disease or a related disorder, or a non-primary diagnosis of dementia unless the primary diagnosis is a major mental disorder as defined here;

2. The disorder results in functional limitations in major life activities within the past three to six months that would be appropriate for the individual's developmental stage. An individual typically has at least one of the following characteristics on a continuing or intermittent basis:

a. Interpersonal functioning. The individual has serious difficulty interacting appropriately and communicating effectively with other persons, has a possible history of altercations, evictions, firing, fear of strangers, avoidance of interpersonal relationships, and social isolation;

b. Concentration, persistence, and pace. The individual has serious difficulty in sustaining focused attention for a long enough period to permit the completion of tasks commonly found in work settings or in work-like structures, activities occurring in school or home settings, manifests difficulties in concentration, inability to complete simple tasks within an established time period, makes frequent errors, or requires assistance in the completion of these tasks; and

c. Adaptation to change. The individual has serious difficulty in adapting to typical changes in circumstances associated with work, school, family, or social interaction, manifests agitation, exacerbated signs and symptoms associated with the illness, or withdrawal from the situation, or requires intervention by the mental health or judicial system.

3. The treatment history indicates that the individual has experienced at least one of the following:

a. Psychiatric treatment more intensive than outpatient care more than once in the past two years (e.g., partial hospitalization or inpatient hospitalization); or

b. Within the last two years, due to the mental disorder, experienced an episode of significant disruption to the normal living situation, for which supportive services were required to maintain functioning at home, or in a residential treatment environment, or which resulted in intervention by housing or law enforcement officials.

"Mental Retardation (MR)" means the presence of a level of retardation (mild, moderate, severe, or profound) described in the American Association on Mental Retardation's Manual on Classification in Mental Retardation (1983) or has a related condition. A person with related conditions (RC) means the individual has a severe chronic disability that meets all of the following conditions:

1. It is attributable to cerebral palsy or epilepsy or any other condition, other than mental illness, found to be closely related to mental retardation because this condition may result in impairment of general intellectual functioning or adaptive behavior similar to that of mentally retarded persons, and requires treatment or services similar to those required for these persons;

2. It is manifested before the person reaches age 22;

3. It is likely to continue indefinitely; and

4. It results in substantial functional limitations in three or more of the following areas of major life activity: self-care, understanding and use of language, learning, mobility, self-direction, and capacity for independent living.

"MI/MR Supplement" means the assessment form developed to meet the requirements of OBRA '87. Its purpose is to identify individuals with mental illness and mental retardation before their admission to a nursing facility.

"New admission" means an individual who is admitted to any nursing facility for the first time or does not qualify as a readmission. New admissions are subject to preadmission screening.

"Non-Medicaid-eligible Individuals" means persons who are not Medicaid eligible or are not expected to be Medicaid eligible within 180 days of admission to a nursing facility.

"Nursing Home Preadmission Screening Committee (NHPASC)" means a committee established for the purpose of determining whether a Medicaid-eligible individual meets nursing facility criteria.

"Qualified Mental Health Professional (QMHP)" means a clinician in the health profession who is trained and experienced in providing psychiatric or mental health services to individuals who have a psychiatric diagnosis. In the Commonwealth, authorized professionals and minimal qualifications for a QMHP are as follows:

1. Physician: a doctor of medicine or osteopathy licensed in Virginia;

2. Psychiatrist: a doctor of medicine or osteopathy, specializing in psychiatry and licensed in Virginia;

3. Psychologist: an individual with a master's degree in psychology from an accredited college or university with at least one year of clinical experience;

4. Social worker: an individual with a master's or bachelor's degree from a school of social work accredited or approved by the Council on Social Work Education with at least one year of clinical experience;

5. Registered nurse: a registered nurse licensed in the State of Virginia with at least one year of clinical experience; and

6. Mental health worker: an individual with professional education, training, and/or a degree in human services or related field from an accredited college deemed equivalent to those described above and at least one year of clinical experience providing direct services to persons with a diagnosis of mental illness.

"Readmission" means an individual who was readmitted to a facility from a hospital to which he or she was transferred for the purpose of receiving care. Readmissions are subject to annual resident review rather than preadmission screening.

"State Mental Health or Mental Retardation Authority (MH/MRA)" means the designated representative of the Department of Mental Health, Mental Retardation and Substance Abuse Services who shall make determinations regarding placement of and services to nursing facility applicants who have conditions of mental illness or mental retardation.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-4.3910 § 1, eff. June 1, 1994.

12VAC30-130-150 Persons subject to nursing home preadmission screening and identification of conditions of mental illness and mental retardation (Level I)

A. As a condition of a nursing facility's Medicaid participation, all persons applying for admission shall be screened to determine whether they have a condition of mental illness (MI) or mental retardation (MR) or a related condition (RC), and if so, whether they require the level of services provided by a nursing facility (NF). Nursing facilities shall ensure that applicants for admission have been screened and those who are identified as being MI or MR/RC are not admitted until determinations have been made by the State Mental Health or Mental Retardation Authority (MH/MHA) with respect to their placement. NHPASCs complete the Level I process for individuals who are Medicaid eligible or expect to become Medicaid eligible within 180 days. Nursing facilities must ensure that the appropriate screenings are conducted for non-Medicaid eligible applicants.

B. No individual, regardless of pay status, may be admitted to a nursing facility unless the Level I screening has been completed, and, if it is determined that the individual has a condition of MI or MR/RC as defined herein, then he or she shall not be admitted until the Level II determination has been made.

C. The Level I identification function shall provide at least, in the case of first time identifications, for the issuance of written notice to the individual or resident and his or her legal representative if the individual is suspected of having MI or MR/RC and is being referred to the MH/MRA for Level II screening. The NHPASC shall send this notice to Medicaid-eligible individuals who are referred for a Level II screening. The admitting NF shall send the notice to non-Medicaid individuals.

D. All Level I and Level II determinations shall be recorded in the individual's medical record.

E. When a preadmission screening has not been performed timely, but is performed at a later date, federal financial participation (FFP) is available only for services furnished after the screening has been performed.

F. The state in which the individual is a resident (or will be at the time he or she becomes eligible for Medicaid) must pay for the PASARR and make the required determinations. In the case of non-Medicaid eligible applicants, the receiving NF is responsible to ensure that the appropriate screenings have been completed prior to the individual's admission.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-4.3910 § 2, eff. June 1, 1994.

12VAC30-130-160 Level II determination

A. For each resident of a NF who has a condition of MI or MR/RC, the MH/MRA, as appropriate, must determine whether the individual requires the level of services provided by a NF, an inpatient psychiatric hospital for individuals under age 21, an institution for mental disease (IMD) providing medical assistance to individuals age 65 and older, an intermediate care facility for the mentally retarded (ICF/MR), or specialized services for either MI or MR/RC.

B. When a Level II evaluation is required, a determination shall be made within an annual average of seven to nine working days of the referral for screening. The MH/MRA shall convey determinations verbally to NFs and the individual and confirm them in writing.

C. The MH/MRA shall notify in writing the following entities of a Level II determination:

1. The evaluated individual and his or her legal representative;

2. The admitting or retaining NF;

3. The individual or resident's attending physician; and

4. The discharging hospital.

D. Each notice described above shall include the following:

1. Whether a NF level of services is needed;

2. Whether specialized services are needed;

3. The placement options available to the individual; and

4. The rights of the individual to appeal the determination.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-4.3910 § 3, eff. June 1, 1994.

12VAC30-130-170 Categorical determinations

A. For each individual for whom the Level I screening has resulted in the determination that the individual meets nursing facility level of care and has a condition of MI or MR/RC as defined herein, a Level II evaluation does not have to be completed if one of the following categorical determinations are met:

1. The individual has a terminal illness in which a physician has documented that life expectancy is less than six months; or

2. The individual has a severe illness such as coma, functioning at brain stem level, or other conditions which result in a level of impairment so severe that the individual could not be expected to benefit from specialized services. When this category is used, documentation shall be available which fully describes the severity of the condition.

B. These categorical determinations shall only be applied following the Level I review and only if existing data on the individual appear to be current and accurate and are sufficient to allow the evaluator readily to determine that the individual fits the category.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-4.3910 § 4, eff. June 1, 1994.

12VAC30-130-180 Annual resident review

A. A review and determination must be conducted for each resident of a NF who has MI or MR/RC not less often than annually. "Annually" is defined as occurring within every fourth quarter after the previous preadmission screening or annual resident review.

B. When an annual resident review has not been performed timely, but is performed at a later date, federal financial participation (FFP) is available only for services furnished after the review has been performed.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-4.3910 § 5, eff. June 1, 1994.

12VAC30-130-190 Determinations and placement of individuals with MI or MR/RC

A. If the MH/MRA determines that a resident or applicant for admission to a NF requires a NF level of services, the NF may admit or retain the individual. If the MH/MRA determines that a resident or applicant for admission requires both a NF level of services and specialized services for MI or MR/RC, the NF may admit or retain the individual and the state must provide or arrange for the provision of the specialized services needed by the individual while he resides in the NF.

B. If the MH/MRA determines that an applicant for admission to a NF does not require NF services, the applicant cannot be admitted. NF services are not a covered Medicaid service for that individual, and further screening is not required.

C. If the MH/MRA determines that a resident requires neither the level of services by a NF nor specialized services for MI or MR/RC, regardless of the length of stay in the facility, the state must (i) arrange for the safe and orderly discharge of the resident from the facility; and (ii) prepare and orient the resident for discharge.

D. For any resident who has continuously resided in a NF for at least 30 months before the date of the determination, and who requires only specialized services, the state must, in consultation with the resident's family or legal representative and caregivers (i) offer the resident the choice of remaining in the facility or of receiving services in an alternative appropriate setting; (ii) inform the resident of the institutional and noninstitutional alternatives available; (iii) clarify the effect on eligibility for Medicaid services if the resident chooses to leave the facility, including its effect on readmission to the facility or eligibility for community-based services; and (iv) regardless of the resident's choice to remain in the NF or to be discharged to a community setting, provide for, or arrange for the provision of specialized services for the MI or MR.

E. For any resident who has not continuously resided in a NF for at least 30 months before the date of the determination, the state must, in consultation with the resident's family or legal representative and caregivers (i) arrange for the safe and orderly discharge of the resident from the facility; (ii) prepare and orient the resident for discharge; and (iii) provide for, or arrange for the provision of, specialized services for the MI or MR.

F. For the purposes of establishing length of stay in a NF, the 30 months of continuous residence in a NF or longer is calculated back from the date of the first annual resident review determination which finds that the individual is not in need of NF level of services. The 30 months of continuous residence in a NF may include temporary absences for hospitalization and therapeutic leave and may consist of consecutive residences in more than one NF.

G. Placement of an individual with MI or MR/RC in a NF may be considered appropriate only when the individual's needs are such that he or she meets the minimum standards for admission and his or her needs for treatment do not exceed the level of services which can be delivered in the NF to which the individual is admitted either through NF services alone or, where necessary, through NF services supplemented by specialized services provided by or arranged for by the state.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-4.3910 § 6, eff. June 1, 1994.

12VAC30-130-200 PASARR evaluation criteria

A. The state's PASARR program must identify all individuals who are suspected of having MI or MR/RC as defined herein. The identification function and determination that NF criteria is met is termed Level I. Level II is the function of evaluating and determining whether NF placement is appropriate to meet the individual's MH/MR/RC needs and whether specialized services are needed.

B. Evaluations performed under PASARR and PASARR notices must be adapted to the cultural background, language, ethnic origin, and means of communication used by the individual being evaluated. PASARR evaluations must involve the individual being evaluated, the individual's legal representative, if one has been designated under state law, and the individual's family if available and the individual or the legal representative agrees to family participation. When parts of a PASARR evaluation are performed by more than one evaluator, there must be interdisciplinary coordination among the evaluators.

C. All information that is necessary for determining whether it is appropriate for the individual with MI or MR/RC to be placed in a NF or in another appropriate setting should be gathered throughout all applicable portions of the PASARR evaluation. The determinations relating to the need for NF level of care and specialized services are interrelated and must be based upon a comprehensive analysis of all data concerning the individual.

D. Evaluators may use relevant evaluative data, obtained prior to initiation of preadmission screening or annual resident review, if the data are considered valid and accurate and reflect the current functional status of the individual. However, in the case of individualized evaluations, the PASARR program may need to gather additional information to supplement and verify the currency and accuracy of existing data and to assess proper placement and treatment.

E. For individualized PASARR determinations, findings must be issued in the form of a written evaluative report which (i) identifies the name and professional title of person(s) who performed the evaluation(s) and the date on which each portion of the evaluation was administered; (ii) provides a summary of the medical and social history, including the positive traits or developmental strengths and weaknesses or developmental needs of the evaluated individual; (iii) if NF services are recommended, identifies the specific services which are required to meet the evaluated individual's needs; (iv) if specialized services are not recommended, identifies any specific MR/RC or MH services which are of a lesser intensity than specialized services that are required to meet the evaluated individual's needs; (v) if specialized services are recommended, identifies the specific MR/RC or MH services required to meet the evaluated individual's needs; and (vi) includes the basis for the report's conclusions.

F. For categorical PASARR determinations, findings must be issued in the form of an abbreviated written evaluative report which (i) identifies the name and professional title of the person applying the categorical determination and the data on which the application was made; (ii) explains the categorical determination(s) that has (have) been made; (iii) identifies, to the extent possible, based on the available data, NF services, including any mental health or specialized psychiatric rehabilitative services, that may be needed; and (iv) includes the bases for the report's conclusions.

G. For both categorical and individualized determinations, findings of the evaluation must correspond to the person's current functional status, mental health, and mental retardation status as documented in medical and social history records. Findings of the evaluation must be interpreted and explained to the individual and, where applicable, to a legal representative designed under state law by the assessment team or the MH/MRA. The evaluation report must be sent to the individual and his legal representative, appropriate state authority in sufficient time to meet the required time frames, admitting or retaining NF, individual's attending physician, and the discharging hospital if the individual is seeking NF admission from a hospital. The evaluation may be terminated at any time during the evaluation that the individual being evaluated does not have MI or MR/RC or has a primary diagnosis of dementia or a nonprimary diagnosis of dementia without a primary diagnosis that is a serious mental illness, and does not have a diagnosis of MR or a related condition.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-4.3910 § 7, eff. June 1, 1994.

12VAC30-130-210 Specialized services

A. For mental illness, specialized services means the services specified by the state which, combined with services provided by the NF, results in the continuous and aggressive implementation of an individualized plan of care that:

1. Is developed and supervised by an interdisciplinary team which includes a physician, qualified mental health professionals, and as appropriate, other professionals;

2. Prescribes specific therapies and activities for the treatment of persons experiencing an acute episode of serious mental illness which necessitates supervision by trained mental health personnel;

3. Is directed toward diagnosing and reducing the resident's behavioral symptoms that may necessitate institutionalization, improving his or her level of independent functioning, and achieving a functioning level that permits reduction in the intensity of mental health services to below the level of specialized services at the earliest possible time; and

4. Prescribes inpatient psychiatric services for any individual determined to be a danger to self or others. For nursing facility residents who are determined to be a danger to self or others due to mental illness, the nursing facility must coordinate admission to an inpatient psychiatric hospital.

B. For mental retardation or related conditions, specialized services means the services specified by the state which, combined with services provided by the NF or other service providers, results in treatment which includes aggressive, consistent implementation of a program of specialized and generic training, treatment, health services and related services that is directed toward the following;

1. The acquisition of the behaviors necessary for the individual to function with as much self-determination and independence as possible; and

2. The prevention or deceleration of regression or loss of current optimal functional status.

C. The state must provide or arrange for the provision of specialized services to all NF residents with MI or MR/RC whose needs are such that continuous supervision, treatment, and training by qualified MH/MR personnel is necessary as identified by their Level I and II assessments. The NF must provide MH or MR/RC services which are of a lesser intensity than specialized services to all residents who need such services.

1. Services that shall be the responsibility of the nursing facility to provide to residents shall include, but are not limited to:

a. Physical therapy

b. Speech-language pathology services

c. Occupational therapy

d. Restorative nursing

e. Behavior management interventions that do not require ongoing consultation and monitoring by a licensed psychiatrist or psychologist

f. Basic grooming and hygiene needs

g. Nutritional needs, including supplements and assistance with eating

h. Adjustment needs resulting from admission to a nursing facility and ongoing psychosocial emotional support

i. Noncustomized durable medical equipment and supplies

2. Specialized services for the purposes of PASARR shall include the following. The State Mental Health or Mental Retardation Authority shall ensure the provision of specialized services when they are provided by a non-Medicaid-enrolled provider or when the services are not covered by Medicaid.

a. Partial hospitalization

b. Transportation to Medicaid-covered services or specialized services necessary to treat conditions of mental illness or mental retardation

c. Day health and rehabilitation

d. Psychosocial rehabilitation

e. Crisis intervention

f. Customized durable medical equipment, for residents without a patient pay, that would allow the resident to participate in specialized services

g. Behavior management interventions requiring ongoing consultation and monitoring by a licensed psychiatrist or psychologist

h. One-to-one supervision necessary for behavior management

i. Vision and hearing needs related to mental illness or mental retardation for persons over age 21

j. Dental needs resulting from mental illness or mental retardation sequela for persons over age 21

k. Habilitation

l. Supported employment for persons with mental illness or mental retardation

m. Case management services

n. Individual psychotherapy

o. Day treatment

p. Individual and group counseling

q. Inpatient psychiatric care

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-4.3910 § 8, eff. June 1, 1994.

12VAC30-130-220 Placement options

A. The placement options and required state actions resulting from PASARR are as follows:

1. Can be admitted to a NF. Any applicant for admission to a NF who has MI or MR/RC and who requires the level of services provided by a NF, regardless of whether specialized services are also needed, may be admitted to a NF, if the placement is appropriate. If specialized services are also needed, the state is responsible for providing or arranging for the provision of the specialized services.

2. Cannot be admitted to a NF. Any applicant for admission to a NF who has MI or MR/RC and who does not require the level of services provided by a NF, regardless of whether specialized services are also needed, is inappropriate for NF placement and must be not be admitted.

3. Can be considered appropriate for continued placement in a NF. Any NF resident with MI or MR/RC who requires the level of services provided by a NF, regardless of the length of his or her stay or the need for specialized services, can continue to reside in the NF, if the placement is appropriate.

4. May choose to remain in the NF even though the placement would otherwise be inappropriate. Any NF resident with MI or MR/RC who does not require the level of services provided by the NF but does require specialized services and who has continuously resided in a NF for at least 30 consecutive months before the date of determination may choose to continue to reside in the facility or to receive covered services in an alternative appropriate institutional or noninstitutional setting. Wherever the resident chooses to reside, the state must meet his or her specialized services needs. The determination notice must provide information concerning how, when, and by whom the various placement options available to the resident will be fully explained to the resident.

5. Cannot be considered appropriate for continued placement in a NF and must be discharged (short-term residents). Any NF resident with MI or MR/RC who does not require the level of services provided by a NF but does require specialized services and who has resided in a NF for less than 30 consecutive months be discharged to an appropriate setting where the state must provide specialized services. The determination notice must provide information on how, when, and by whom the resident will be advised of discharge arrangements and of his/her appeal rights under both PASARR and discharge provisions.

6. Cannot be considered appropriate for continued placement in a NF and must be discharged (short or long-term residents). Any NF resident with MI or MR/RC who does not require the level of services provided by a NF and does not require specialized services regardless of his or her length of stay, must be discharged. The determination notice must provide information on how, when and by whom the resident will be advised of discharge arrangements and of his or her appeal rights under both PASARR and discharge provisions.

7. Specialized services needed in a NF. If a determination is made to admit or allow to remain in a NF any individual who requires specialized services, the determination must be supported by assurances that the specialized services that are needed can and will be provided or arranged for in a timely manner by the state which the individual resides in the NF.

B. The state PASARR system shall maintain records of evaluations and determinations, regardless of whether they are performed categorically or individually, in order to support its determinations and actions and to protect the appeal rights of individuals subjected to PASARR. The state PASARR system shall establish and maintain a tracking system for all individuals with MI or MR/RC in NFs to ensure that appeals and future reviews are performed.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-4.3910 § 9, eff. June 1, 1994.

12VAC30-130-230 Evaluating the need for NF services and NF level of care (PASARR/NF)

A. For each applicant for admission to a NF and each NF resident who has MI or MR/RC, the evaluator must assess whether (i) the applicant's or resident's total needs are such that his needs can be met in an appropriate community setting; (ii) the individual's total needs are such that they can be met only on an inpatient basis, which may include the option of placement in a home and community-based services waiver program, but for which the inpatient care would be required; (iii) if inpatient care is appropriate and desired, the NF is an appropriate institutional setting for meeting those needs; or (iv) if the inpatient care is appropriate and desired but the NF is not the appropriate setting for meeting the individual's needs, another setting such as an ICF/MR (including small, community-based facilities), an IMD providing services to individuals ages 65 or older, or a psychiatric hospital is an appropriate institutional setting for meeting those needs.

B. In determining appropriate placement, the evaluator must prioritize the physical and mental needs of the individual being evaluated, taking into account the severity of each condition.

C. At a minimum the data relied on to make a determination must include: (i) evaluation of physical status (for example, diagnoses, date of onset, medical history, and prognosis); (ii) evaluation of mental status (for example, diagnoses, date of onset, medical history, likelihood that the individual may be a danger to himself/herself or others); and (iii) functional assessment (activities of daily living).

D. Based on the data compiled, the MH/MRA must determine whether an NF level of services is needed.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-4.3910 § 10, eff. June 1, 1994.

12VAC30-130-240 Evaluating whether an individual with MI requires specialized services (PASARR/MI)

A. The purpose of this section is to identify the minimum data needs and process requirements for the state MHA, which is responsible for determining whether or not the applicant or resident with MI needs a specialized services program for mental illness.

B. Minimum data collected must include:

1. A comprehensive history and physical examination of the person. If the history and physical examination are not performed by a physician, then a physician must review and concur with the conclusions. The following areas must be included (if not previously addressed): complete medical history; review of all body systems; specific evaluation of the person's neurological system in the areas of motor functioning, sensory functioning, gait, deep tendon reflexes, cranial nerves, and abnormal reflexes; and in case of abnormal findings which are the basis for a NF placement, additional evaluations conducted by appropriate specialists.

2. A comprehensive drug history including current or immediate past use of medications that could mask symptoms or mimic mental illness.

3. A psychological evaluation of the person, including current living arrangements and medical and support systems.

4. A comprehensive psychiatric evaluation including a complete psychiatric history, evaluation of intellectual functioning, memory functioning, and orientation, description of current attitudes and overt behaviors, affect, suicidal or homicidal ideation, paranoia, and degree of reality testing (presence and content of delusions) and hallucinations.

5. A functional assessment of the individual's ability to engage in activities of daily living and the level of support that would be needed to assist the individual to perform these activities while living in the community. The assessment must determine whether this level of support can be provided to the individual in an alternative community setting or whether the level of support needed is such that NF placement is required. The functional assessment must address the following areas: Self-monitoring of health status, self-administering and scheduling of medical treatment, including medication compliance, or both, self-monitoring of nutritional status, handling money, dressing appropriately, and grooming.

C. The state may designate the mental health professionals who are qualified to perform the evaluations required including the comprehensive drug history; psychosocial evaluation; comprehensive psychiatric evaluation; functional assessment; and to make the determination required.

D. Based on the data compiled, a qualified mental health professional, as designated by the state, must validate the diagnosis of mental illness and determine whether a program of psychiatric specialized services is needed.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-4.3910 § 11, eff. June 1, 1994.

12VAC30-130-250 Evaluating whether an individual with MR/RC requires specialized services (PASARR/MR)

A. The purpose of this section is to identify the minimum data needs and process requirements for the state MRA to determine whether or not the applicant or resident with mental retardation or a related condition needs a continuous specialized services program. Minimum data collected must include the individual's comprehensive history and physical examination results to identify the following information or, in the absence of data, must include information that permits a reviewer specifically to assess:

1. The individual's medical problems;

2. The level of impact these problems have on the individual's independent functioning;

3. All current medications used by the individual and the current response of the individual to any prescribed medications in the following drug groups: hypnotics, antipsychotics (neuroleptics), mood stabilizers and antidepressants, antianxiety-sedative agents, and anti-Parkinsonian agents.

4. Self-monitoring of health status;

5. Self-administering and scheduling of medical treatments;

6. Self-monitoring of nutritional status;

7. Self-help development such as toileting, dressing, grooming, and eating;

8. Sensorimotor development, such as ambulation, positioning, transfer skills, gross motor dexterity, visual motor perception, fine motor dexterity, eye-hand coordination, and extent to which prosthetic, orthotic, corrective or mechanical supportive devices can improve the individual's functional capacity;

9. Speech and language (communication) development, such as expressive language (verbal and nonverbal), receptive language (verbal and nonverbal), extent to which nonoral communication systems can improve the individual's function capacity, auditory functioning, and extent to which amplification devices (e.g. hearing aid) or a program of amplification can improve the individual's functional capacity;

10. Social development, such as interpersonal skills, recreation-leisure skills, and relationships with others;

11. Academic/educational development, including functional learning skills;

12. Independent living development such as meal preparation, budgeting and personal finances, survival skills, mobility skills (orientation to the neighborhood, town, city), laundry, housekeeping, shopping, bed making, care of clothing, and orientation skills (for individuals with visual impairments);

13. Vocational development, including present vocational skills;

14. Affective development such as interests, and skills involved with expressing emotions, making judgments, and making independent decisions; and

15. The presence of identifiable maladaptive or inappropriate behaviors of the individual based on systematic observation (including, but not limited to, the frequency and intensity of identified maladaptive or inappropriate behaviors).

B. The state must ensure that a licensed psychologist identifies the intellectual functioning measurement of individuals with MR or a related condition. Based on the data compiled, the MRA, using appropriate personnel as designated by the state, must validate that the individual has MR or is a person with a related condition and must determine whether specialized services for MR/RC are needed. In making this determination, the MHA must make a qualitative judgment on the extent to which the person's status reflects, singly and collectively, the characteristics commonly associated with the need for specialized services, including:

1. Inability to take care of most personal care needs; understand simple commands; communicate basic needs and wants; be employed at a productive wage level without systematic long term supervision or support; learn new skills without aggressive and consistent training; apply skills learned in a training situation to other environments or settings without aggressive and consistent training; demonstrate behavior appropriate to the time, situation or place without direct supervision; and make decisions requiring informed consent without extreme difficulty;

2. Demonstration of severe maladaptive behavior(s) that place the person or others in jeopardy to health and safety; and

3. Presence of other skill deficits or specialized training needs that necessitate the availability of trained MR personnel, 24 hours per day, to teach the person functional skills.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-4.3910 § 12, eff. June 1, 1994.

12VAC30-130-260 Appeals

A. Following notification to the NF of the Level II assessment determination by the state MH/MRA, the NF must inform the individual of the decision indicating the reasons for acceptance or denial and the method of appeal. Any individual, regardless of method of payment, who wishes to appeal the decision of the Level II evaluation may do so by sending written notification to the Department of Medical Assistance Services, Division of Client Appeals.

B. Decisions made by the annual resident review teams shall also be appealable to DMAS. The reviewed individual shall send written notification to DMAS, Division of Client Appeals.

C. All appeal requests must be made within 30 days of the individual's notification of the review decision.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-4.3910 § 13, eff. June 1, 1994; amended, Virginia Register Volume 25, Issue 14, eff. April 15, 2009.

Part IV Drug Utilization Review Program

12VAC30-130-270 Definitions

The following words and terms when used in this part shall have the following meanings unless the context clearly indicates otherwise:

"Abuse" means (i) use of health services by recipients which is inconsistent with sound fiscal or medical practices and that results in unnecessary costs to the Virginia Medicaid program or in reimbursement for a level of use or a pattern of services that is not medically necessary, or (ii) provider practices which are inconsistent with sound fiscal or medical practices and that result in (a) unnecessary costs to the Virginia Medicaid program, or (b) reimbursement for a level of use or a pattern of services that is not medically necessary or that fails to meet professionally recognized standards for health care.

"Appropriate and medically necessary" means drug prescribing and dispensing practices which conform with the criteria and standards developed pursuant to this regulation and are consistent with the diagnosis or treatment of an identified condition.

"Criteria and standards" means predetermined objective tests established by or approved by the Drug Utilization Review Board for use in both retrospective and prospective screening of the quality and appropriateness of pharmacy services for Medicaid recipients. Objective tests shall include both criteria, which are based upon professional expertise, prior experience, and the professional literature with which the quality, medical necessity, and appropriateness of health care services may be compared, and standards, which are professionally developed expressions of the range of acceptable variation from a criterion.

"Code" means the Code of Virginia.

"DMAS" means the Department of Medical Assistance Services consistent with Chapter 10 (§ 32.1-323 et seq.) of Title 32.1 of the Code of Virginia.

"Director" means the Director of DMAS.

"Drug Utilization Review (DUR)" means a formal continuing program for assessing medical and recipients' drug utilization data against explicit standards and criteria and, as necessary, introducing remedial strategies.

"Drug Utilization Review Board (DUR Board)" means the group of health care professionals appointed by the director and established pursuant to § 1927(g)(3) Title XIX of the Social Security Act.

"Drug Utilization Review Committee (DUR Committee)" means a committee composed of health care professionals who make recommendations for developing and modifying drug therapy review standards or criteria, participate in retrospective reviews, recommend remedial strategies, and evaluate the success of the interventions.

"Exceptional drug utilization pattern" means a pattern of drug use that differs from the standards and criteria established pursuant to this part.

"Fraud" means any act including intentional deception or misrepresentation that constitutes fraud under applicable federal or state laws.

"OBRA 90" means the Omnibus Budget Reconciliation Act of 1990.

"Patient's agent" means the person or persons selected by the recipient to act on his behalf with regard to the recipient's receipt of Title XIX pharmacy services.

"Patient counseling" means communication of information by the pharmacist, in person whenever practicable, to patients receiving benefits under Title XIX of the Social Security Act or the patient's agent, to improve therapeutic outcomes by encouraging proper use of prescription medications and devices.

"Prospective drug utilization review" means a review by the pharmacist of the prescription medication order and the patient's drug therapy before each prescription is filled. The review shall include an examination of any patient profile (which has been maintained by the pharmacist) to determine the possibility of potential drug therapy problems due to therapeutic duplication, drug-disease contraindications, drug-drug interactions (including serious interactions with nonprescription or over-the-counter drugs, incorrect drug dosage or duration of drug treatment, drug-allergy interactions, and clinical abuse or misuse).

"Restriction" means (i) an administrative limitation imposed by DMAS on a recipient which requires the recipient to obtain access to specific types of health care services only through a designated primary provider or (ii) an administrative limitation imposed on a provider to prohibit participation as a designated primary provider, referral provider, or covering provider for restricted recipients.

"Retrospective drug utilization review" means the drug use review process that is conducted by DMAS using historic or archived medical or drug use data which may include but is not restricted to patient profiles and historical trends.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-4.2600 § 1, eff. June 16, 1993; amended, Virginia Register Volume 25, Issue 14, eff. April 15, 2009.

12VAC30-130-280 Authority

Section 1927 of Title XIX Social Security Act provides the authority for this program.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-4.2600 § 2, eff. June 16, 1993.

12VAC30-130-290 Scope and purpose

A. DMAS shall implement and conduct a drug utilization review program (DUR program) for covered drugs prescribed for eligible recipients. The program shall help to ensure that prescriptions are appropriate, medically necessary, and are not likely to cause medically adverse events. The program shall provide for ongoing retrospective DUR, prospective DUR and an educational outreach program to educate practitioners on common drug therapy problems with the aim of improving prescribing practices. As needed, the program shall also provide for electronic messages as well as rejected or denied services when such claims are not consistent with DUR criteria and requirements. The primary objectives shall be:

1. Improving in the quality of care;

2. Maintaining program integrity (i.e., controlling problems of fraud and benefit abuse); and

3. Conserving program funds and individual expenditures.

B. Certain organized health care settings shall be exempt from the further requirements of retrospective and prospective DUR process as provided for in § 4401 of OBRA 90.

C. The purpose of retrospective DUR shall be to screen for:

1. Monitoring for therapeutic appropriateness;

2. Overutilization and underutilization;

3. Appropriate use of generic products;

4. Therapeutic duplication;

5. Drug-disease/health contraindications;

6. Drug-drug interactions;

7. Incorrect drug dosage or duration of treatment;

8. Clinical abuse/misuse and fraud, and as necessary

9. Introduce to physicians and pharmacists remedial strategies to improve the quality of care rendered to their patients.

D. The purpose of prospective DUR shall be to screen for:

1. Potential drug therapy problems due to therapeutic duplication;

2. Drug-disease/health contraindications;

3. Drug-drug interactions (including serious interactions with nonprescription or over-the-counter drugs);

4. Incorrect drug dosage or duration of drug treatment;

5. Drug-allergy interactions; and

6. Clinical abuse and misuse.

E. In instances where initial claims for reimbursement of covered services are determined to be in conflict with DUR criteria and requirements, such claims shall receive electronic messages or be rejected or denied, as appropriate, back to the dispensing pharmacist with notification as to the substance of the conflict. The dispensing pharmacist will be afforded the opportunity to provide an intervention, based on his professional expertise and knowledge, to modify the service to be claimed for reimbursement. If the modification no longer conflicts with the DUR criteria, the claim for the modified service shall be adjudicated for payment. If the modification requires additional information from the prescriber, the pharmacist shall advise the prescribing physician of the continuing conflict and advise the physician to seek prior authorization approval from either DMAS or the pharmacy benefits contractor for his treatment plans.

F. Designated interventions may include provider override, obtaining prior authorization via communication to a call center staffed with appropriate clinicians, or written communication to prescribers.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-4.2600 § 3, eff. June 16, 1993; amended, Virginia Register Volume 21, Issue 6, eff. January 3, 2005; Volume 25, Issue 14, eff. April 15, 2009.

12VAC30-130-300 Retrospective DUR

A. The retrospective DUR program shall provide, through drug claims processing and information retrieval systems, for ongoing periodic examination of claims data and other records in order to identify patterns of fraud, abuse, overuse, or inappropriate or medically unnecessary care among physicians, pharmacists, and individuals receiving benefits under Title XIX of the Social Security Act.

B. The DUR program shall, on an ongoing basis, assess data on drug use against predetermined criteria and standards which have been approved by the DUR Board.

C. Summary data concerning identified exceptional drug utilization patterns shall be developed and submitted by DMAS to the DUR Board at least quarterly, or as often as monthly if requested by the DUR Board. This data shall include at least a summary of the drug therapy problems most often observed in the course of retrospective reviews, summaries of physician responses to educational interventions, and the results of intensified reviews and monitoring of selected prescribers or dispensers.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-4.2600 § 4, eff. June 16, 1993.

12VAC30-130-310 Prospective DUR

A. Patient medication profile. On and after January 1, 1993, pharmacists shall make a reasonable effort to maintain a patient medication record system for persons covered under Title XIX of the Social Security Act for whom prescriptions are dispensed. For purposes of this regulation, a reasonable effort shall have been made if the information set forth in subdivision 1 of this subsection is requested by the pharmacist or the pharmacist's designee from the patient or the patient's agent.

1. A reasonable effort shall be made by the participating pharmacist to obtain, record, and maintain at least the following information on each patient's profile:

a. Patient's name, address, telephone number;

b. Date of birth (or current age) and gender;

c. Medical history

(1) Significant patient health problems known to the pharmacist,

(2) Prescription drug reactions or known allergies,

(3) A comprehensive list of prescription and nonprescription medications and legend drug administration devices known by the pharmacist to have been used by the patient; and

d. Prescriber information to include, but not necessarily be limited to, name, address, and Medicaid and Drug Enforcement Agency (DEA) provider numbers.

e. Pharmacist's comments relevant to the patient's drug use, including any failure to accept the pharmacist's offer to counsel.

2. Such information may be recorded in any system of records and may be considered by the pharmacist in the exercise of his professional judgment concerning both the offer to counsel and content of counseling. DMAS or its designated agent is authorized to survey pharmacists' patients in order to determine compliance with and report on the mandates of federal and state law and regulations.

3. The information for patient profiles may be obtained from a patient's prescribing physician, hospital medical records, interviews with the patient, patient's family or agent, or a combination of the above.

4. Patient medication profiles shall be maintained for a period of not less than two years from the date of last entry or as necessary to comply with state or federal law.

B. Pharmacist's responsibilities. Upon receipt of each prescription and before dispensing the medication, a pharmacist shall perform prospective DUR based on his professional knowledge and the criteria and standards approved by the DUR Board, using the information contained in the patient's profile.

If an exception to one or more prospective DUR criteria is identified, a message will be transmitted to the pharmacist. Claims may be rejected due to the exceptions to one or more criteria. Pharmacists may be required to obtain prior authorization, defined as the process of reviewing drugs to determine if medically justified prior to the submission of a claim for payment by Medicaid, in order to dispense the medications.

Designated interventions may include provider override, obtaining prior authorization via communication to a call center staffed with appropriate clinicians, or written communication to prescribers.

C. Patient counseling. Consistent with federal law and regulation a pharmacist must offer to discuss in person, whenever practicable, or through access to a telephone service which is toll-free for long-distance calls with each individual receiving benefits or the caregiver of such individual who presents a prescription, matters which in the exercise of the pharmacist's professional judgment are deemed to be significant. The offer to counsel shall be made consistent with the requirements in § 54.1-3319 B of the Code of Virginia.

The specific areas of counseling shall include those matters listed below that, in the exercise of his professional judgment, the pharmacist considers significant:

1. Name and description of the medication;

2. Dosage form and amount, route of administration, and duration of therapy;

3. Special directions for preparation, administration and use by the patient as deemed necessary by the pharmacist;

4. Common or severe side or adverse effects or interactions that may be encountered which may interfere with the proper use of the medication as was intended by the prescriber, and the action required if they occur;

5. Techniques for self-monitoring drug therapy;

6. Proper storage;

7. Prescription refill information;

8. Action to be taken in the event of a missed dose.

9. Any other matters the pharmacist considers significant.

Alternative forms of patient information may be used to supplement, but not replace, oral patient counseling.

A pharmacist shall not be required to provide oral consultation when a patient or a patient's agent refuses the pharmacist's attempt to consult.

When prescriptions are delivered to the patient or patient's agent who resides outside of the local telephone calling area of the pharmacy, the pharmacist shall either provide a toll free telephone number or accept collect calls from such patient or patient's agent.

Patient counseling as described in this part shall not be required for inpatients of a hospital or institution where a nurse or other person authorized by the Commonwealth is administering the medication.

D. Compliance monitoring. An ongoing program shall be developed for the purpose of monitoring pharmacists' compliance with the prospective DUR requirements of this part.

The director may establish the compliance monitoring program through agreements with other state agencies, the DUR Board or other organizations.

As determined to be appropriate by DMAS, the methods used to monitor compliance shall include but shall not be limited to:

1. On-site inspections,

2. Patient surveys,

3. Desk audits, or

4. Retrospective pharmacy profile reviews.

5. Electronic messages as well as rejection or denial of claims until there is resolution of the conflict with DUR criteria.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-4.2600 § 5, eff. June 16, 1993; amended, Virginia Register Volume 21, Issue 6, eff. January 3, 2005.

12VAC30-130-320 Criteria and standards for DUR

The DUR Board shall establish and revise as necessary a list of approved criteria and standards which shall be consistent with the following:

1. Compendia which shall consist of at least the publications, as may be amended from time to time, that are referenced at 12VAC30-10-650 C.

2. The peer-reviewed medical literature; and

3. Commonly accepted standards of medical practice as used by practitioners across the Commonwealth

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-4.2600 § 6, eff. June 16, 1993; amended, Virginia Register Volume 21, Issue 6, eff. January 3, 2005.

12VAC30-130-330 Educational program

A. DMAS shall develop an educational program designed to further educate physicians and pharmacists to ensure that prescriptions are appropriate, medically necessary, and are not likely to cause adverse actions. The purpose of such program shall be to:

1. Identify and reduce the frequency of patterns of fraud, abuse, overuse, or inappropriate or medically unnecessary care among physicians, pharmacists, and patients, or associated with specific drugs or groups of drugs;

2. Identify and reduce the potential and actual severe adverse reactions to drugs; and

3. Improve prescribing and dispensing practices.

Such program shall include education on therapeutic appropriateness, overutilization and underutilization, appropriate use of generic products, therapeutic duplication, drug-disease contraindications, drug-drug interactions, incorrect drug dosage or duration of drug treatment, drug-allergy interactions and clinical abuse/misuse.

B. The educational program shall be accomplished through the use of interventions. The interventions shall be directed to physicians and pharmacists and shall address therapy problems or individuals identified in the course of prospective and retrospective drug use reviews as having exceptional drug utilization patterns. The educational program shall have at least four types of interventions which shall be used as appropriate. These interventions shall include:

1. Information dissemination sufficient to ensure the ready availability to participating physicians and pharmacists of information concerning the DUR Board's duties, powers, and basis for its standards;

2. Written, oral, electronic, and telephonic reminders containing patient-specific or drug-specific (or both) information and suggested changes in prescribing or dispensing practices, which is communicated in a manner designed to ensure the privacy of patient-related information;

3. Face-to-face discussions between health care professionals who are experts in appropriate and medically necessary drug therapy and selected prescribers and pharmacists who have been targeted for intervention, including discussion of optimal prescribing, dispensing, or pharmacy care practices, and follow-up face-to-face discussions; and

4. Intensified review or monitoring of selected prescribers or dispensers.

C. DMAS may establish the educational program through contracts with accredited health care educational institutions, state medical societies or state pharmacists associations/societies or other organizations, which may include, but shall not necessarily be limited to, a pharmacy benefits manager. The educational program will use, but not be limited to, as a basis for its educational activities the compendia and literature referenced in these regulations and data obtained primarily from the prospective and retrospective DUR process, and provided by the DUR Board, on common drug therapy problems and other utilization and drug therapy issues listed in these regulations. The educational program shall be based on recommendations submitted by the DUR Board.

D. A report shall be prepared by the DUR Board and submitted to the director at least semi-annually evaluating the success of the interventions, determining if the interventions improved the quality of drug therapy, and making recommendations for modifications in the program, if appropriate.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-4.2600 § 7, eff. June 16, 1993; amended, Virginia Register Volume 21, Issue 6, eff. January 3, 2005.

12VAC30-130-335 Other interventions

As permitted by all applicable federal and state laws and regulations, DMAS or its designee may intervene in the process of the adjudication of claims for payment of prescription drugs. Such interventions may entail, but shall not be limited to, electronic messages, rejecting claims pending further resolution, or requiring prior authorization for selected prospective DUR criteria.

Designated interventions may include provider override, obtaining prior authorization via communication to a call center staffed with appropriate clinicians, or written communication to prescribers.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 6, eff. January 3, 2005.

12VAC30-130-340 DUR Board

A. The Director of DMAS shall establish the DUR Board either directly or through a contract with an outside vendor. The DUR Board shall submit recommendations on prospective and retrospective drug use review to the director. The director reserves the right to reject such recommendations and shall so notify the board consistent with federal requirements. The DUR Board shall adhere to all the requirements of client confidentiality with respect to patient specific information.

B. The DUR Board shall consist of 13 members. At least one-third of the members shall be pharmacists. At least one-third but no more than 51% of the members shall be physicians. There shall be at least one but no more than two nurse members. All pharmacist, physician and nurse members shall be licensed by the Commonwealth with such licenses in good standing. The Director of DMAS shall invite submission of candidates from each of these groups. Other individuals and groups interested in submitting names of candidates for the DUR Board shall indicate their interest to the director in writing. The director shall appoint the physician members from candidates submitted by the Medical Society of Virginia, the Old Dominion Medical Society, and each of the medical schools in the Commonwealth. The director shall appoint the pharmacist members from candidates submitted by the Medical College of Virginia/Virginia Commonwealth University School of Pharmacy, the Virginia Pharmaceutical Association, Virginia Chain Drug Store Association, and the Virginia Society of Consultant Pharmacists. The director shall appoint the nurse member or members from candidates submitted by the Virginia Nurses Association.

1. At least five of the physicians and pharmacists appointed to the DUR Board shall be licensed and actively practicing.

2. All individuals appointed to the DUR Board shall demonstrate knowledge and expertise in one or more of the following areas:

a. The clinically appropriate prescribing of covered outpatient drugs;

b. The clinically appropriate dispensing and monitoring of outpatient drugs;

c. Drug use review, evaluation, and intervention; and

d. Medical quality assurance.

C. Consistent with its by-laws, the DUR Board members shall serve at the pleasure of the director, for terms established by the director. Vacancies shall be filled in the same manner as the original appointment.

D. DMAS shall provide staff assistance to the DUR Board and its officers in the routine conduct of its business.

E. The DUR Board shall have the following duties:

1. The DUR Board shall meet no less than quarterly and, in addition, upon call by the director. A quorum for action by the DUR Board shall be seven voting members.

2. The DUR Board shall elect from among its members a chairperson and a vice-chairperson. Officers may be elected to successive terms.

3. A full record of the board's proceedings shall be kept. The record shall be open to public inspection at all reasonable times consistent with the DMAS' hours of operation.

4. The DUR Board shall establish such rules as are necessary to conduct its business.

5. The DUR Board shall review and approve the retrospective DUR criteria for consistency with the requirements set forth in these regulations.

6. The DUR Board shall establish a listing of criteria and standards for use in prospective drug use reviews. The criteria and standards may include commercial software packages, drug interaction handbooks, and other published and written criteria.

7. The DUR Board shall submit a report at least semi-annually evaluating the success of interventions and making recommendations for modifications to the educational program, if appropriate. The DUR Board shall evaluate the educational program developed by DMAS or DMAS' vendor pursuant to the requirements of these regulations and make recommendations concerning the appropriate mix of intervention approaches.

8. The DUR Board shall prepare a report on an annual basis for submission to the director which shall include a description of the activities of the DUR Board, including the nature and scope of the prospective and retrospective drug use review programs, a summary of the interventions used, an assessment of the impact of the interventions on quality of care, an estimate of the costs and savings generated as a result of such program and other information specified by the director. DMAS shall prepare and submit, on an annual basis, a report to the U.S. Secretary of Health and Human Services that incorporates the DUR Board's report and conforms to the requirements set forth in federal regulations.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-4.2600 § 8, eff. June 16, 1993.

12VAC30-130-350 DUR Committee

A. The director shall provide for the establishment of a DUR Committee either directly or through a contract with an outside vendor. The DUR Board may serve as the DUR Committee.

B. The membership of the DUR Committee shall include health care professionals who have recognized knowledge and expertise in one or more of the following:

1. The clinically appropriate prescribing of covered drugs;

2. The clinically appropriate dispensing and monitoring of covered drugs;

3. Drug use review, evaluation, and intervention; and

4. Medical quality assurance.

C. The membership of the DUR Committee shall include physicians, pharmacists, and other health care professionals.

D. Activities of the DUR Committee shall include, but not be limited to, the following:

1. The review of patient, pharmacist, and physician exceptional drug utilization profiles generated from retrospective reviews applying knowledge and experience as a professional and the retrospective criteria and standards approved by the DUR Board;

2. Develop and recommend modifications to the prospective and retrospective standards based on clinical experience, new literature findings, and communications from practitioners pursuant to the educational program;

3. In instances where an exceptional drug use pattern is suggestive of fraud or abuse, make referrals in a manner consistent with the rules adopted by the DUR Board to the appropriate intra agency division;

4. Provide technical expertise to assist DMAS staff in the compilation of reports and recommendations to be presented to the DUR Board and the director.

E. The DUR Committee shall adhere to all the requirements of client confidentiality with respect to patient specific information.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-4.2600 § 9, eff. June 16, 1993.

12VAC30-130-360 Exemption of organized health care settings

A. Covered outpatient drugs dispensed by health maintenance organizations, including those organizations that contract under § 1903(m) of the Act, are not subject to the requirements of this section.

B. A hospital (providing medical assistance under the Commonwealth's plan) that dispenses covered outpatient drugs using drug formulary systems, and bills DMAS no more than the hospital's purchasing costs for covered outpatient drugs (as determined under the State plan) shall not be subject to the requirements of this regulation.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-4.2600 § 10, eff. June 16, 1993.

12VAC30-130-370 (Repealed.)

History

• Historical Notes: Derived from VR460-04-4.2600 § 11, eff. June 16, 1993; repealed, Virginia Register Volume 25, Issue 14, eff. April 15, 2009.

Part V Drug Utilization Review in Nursing Facilities

12VAC30-130-380 Definitions

The following words and terms, when used in this part, shall have the following meanings unless the context clearly indicates otherwise:

"DMAS" means the Department of Medical Assistance Services consistent with Chapter 10 (§ 32.1-323 et seq.) of Title 32.1 of the Code of Virginia.

"Drug utilization review" or "DUR" means a formal continuing program for assessing medical or drug use data against explicit standards and, as necessary, introducing remedial strategies.

"Drug Utilization Review Committee (DUR Committee)" means a committee composed of knowledgeable health care professionals who make recommendations for developing and modifying drug therapy review standards or criteria, participate in retrospective reviews, recommend remedial strategies, and evaluate the success of the interventions.

"Exceptional drug utilization pattern" means (i) a pattern of drug utilization within a nursing facility that differs substantially from predetermined standards established pursuant to 12VAC30-130-400 B; (ii) individual resident's drug use patterns that differ from the established standards; or (iii) individual resident's drug use patterns that exhibit a high risk for drug therapy induced illness.

"Retrospective utilization drug review" means the drug utilization review process that is conducted using historic or archived medical or drug use data.

"Targeted facility" means a nursing facility where residents' patterns of drug utilization demonstrate an exceptional drug utilization pattern as defined herein.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-05-3000 § 1, eff. September 25, 1991; amended, Virginia Register Volume 25, Issue 14, eff. April 15, 2009.

12VAC30-130-390 Scope

A. Medicaid shall conduct a drug utilization review program for covered drugs prescribed for nursing facility residents. The program shall help to ensure that prescriptions are appropriate, medically necessary, and are not likely to cause adverse actions. The primary objectives are (i) improvement in the quality of care: (ii) conserving program funds and individual expenditures: and (iii) maintaining program integrity (i.e., controlling problems of fraud and benefit abuse).

B. Retrospective drug utilization review will be conducted on an ongoing basis in targeted nursing facilities demonstrating exceptional drug utilization patterns.

C. With the aim of improving prescribing practices, the program shall provide for ongoing educational outreach programs to educate practitioners on common drug therapy problems.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-05-3000 § 2, eff. September 25, 1991.

12VAC30-130-400 Utilization review process

A. The program shall provide, through its drug claims processing and information retrieval systems, for the ongoing periodic retrospective examination of claims data and other records for targeted facilities to identify patterns of inappropriate or medically unnecessary care for individuals receiving benefits under Title XIX of the Social Security Act.

B. The program shall, on an ongoing basis, assess data on drug use against predetermined standards (as described in this section) including, but not limited to, monitoring for therapeutic appropriateness, overutilization and underutilization, appropriate use of generic products, therapeutic duplication, drug-disease contraindications, drug/drug interactions, incorrect drug dosage or duration of treatment, clinical abuse/misuse, fraud, and, as necessary, introduce to physicians and pharmacists remedial strategies in order to improve the quality of care.

C. The Department of Medical Assistance Services may assess data on drug use against such standards as contained in the publications, as may be amended from time to time, that are referenced at 12VAC30-10-650 C and any other appropriate peer-reviewed medical literature.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-05-3000 § 3, eff. September 25, 1991; amended, Virginia Register Volume 21, Issue 6, eff. January 3, 2005.

12VAC30-130-410 (Repealed.)

History

• Historical Notes: Derived from VR460-05-3000 § 4, eff. September 25, 1991; repealed, Virginia Register Volume 25, Issue 14, eff. April 15, 2009.

12VAC30-130-420 Medical quality assurance

A. Documentation of drug regimens in nursing facilities shall, at a minimum:

1. Be included in a plan of care that must be established and periodically reviewed by a physician;

2. Indicate all drugs administered to the resident in accordance with the plan with specific attention to frequency, quantity, and type and identify who administered the drug (include full name and title); and

3. Include the drug regimen review prescribed for nursing facilities in regulations implementing Section 483.60 of Title 42, Code of Federal Regulations.

B. Documentation specified in subsection A will serve as the basis for drug utilization reviews provided for in this part.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-05-3000 § 5, eff. September 25, 1991.

Part VI Criteria for Intermediate Care for Mentally Retarded Persons

12VAC30-130-430 Introduction

A. Utilization control regulations require that the level of care criteria be formulated for guidance for appropriate levels of care. Traditionally, intermediate care for the mentally retarded has been institutionally based; however, this level of care need not be confined to a specific setting. The habilitative and health needs of the client are the determining issues.

B. The purpose of this chapter is to establish standard criteria to measure eligibility for Medicaid payment. Medicaid can pay for care only when the client is in the appropriate level of care and when "active treatment" is being provided. An individual's need for care must meet these criteria before any authorization for payment by Medicaid will be made for either institutional or waivered rehabilitative services for the mentally retarded.

C. Intermediate care for the mentally retarded requires planned programs for habilitative needs or health related services which exceed the level or room, board, combination of habilitative, rehabilitative, and health services directed toward increasing the functional capacity of the retarded person. Examples of services will include training in the activities of daily living, task-learning skills, socially acceptable behaviors, basic community living programming, or health care and health maintenance. The overall objective of programming shall be the attainment of the optimal physical, intellectual, social, or task learning level which the person can presently or potentially achieve.

D. The evaluation and reevaluation for intermediate care are based on the needs of the person, the reasonable expectations of the resident's capabilities, the appropriateness of programming, whether progress is demonstrated from the training and, in an institution, whether the services could reasonably be provided in a less restrictive environment.

E. The final determination of a person's need for intermediate level of care is a professional decision based on total needs. Mentally retarded persons as individuals present an infinite variety of needs, making it virtually impossible to establish an evaluation system that will eliminate the need for professional judgement within the confines of program criteria.

F. The following criteria are divided into broad categories of needs, or services provided. These must be evaluated in detail to determine the abilities/skills which the client has acquired. The evaluation will then identify training needs/skills which will be the basis for the development of a plan of care.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.2 § 1, eff. December 26, 1985.

12VAC30-130-440 Definitions

The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise:

"No assistance" means no help is needed.

"Often" means occurs two to three times a month.

"Prompting/structuring" means prior to the functioning, some verbal direction or rearrangement of the environment is needed.

"Rarely" means occurs quarterly or less.

"Regularly" means occurs weekly or more.

"Some direct assistance" means helper must be present and provide some physical guidance/support (with or without verbal direction).

"Sometimes" means occurs once a month.

"Supervision" means helper must be present during function and provide only verbal direction, gestural prompts, or guidance.

"Total assistance" means helper must perform all or nearly all of the functions.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.2 § 2, eff. December 26, 1985.

12VAC30-130-450 Patient assessment criteria

A. The evaluation process will demonstrate a need for programming an array of skills and abilities or health care services. These have been organized into seven major categories. The level of functioning in each category is graded from the most dependent to the least dependent. In some categories, the dependency status is rated by the degree of assistance required. In other categories, the dependency is established by the frequency of a behavior or ability to perform a given task.

The resident must meet the indicated dependency level in two or more of the categories 1 through 7.

1. Health status. To meet this category:

a. Two or more questions must be answered with a "4," or

b. Question 10 must be answered "yes".

2. Communication skills. To meet this category:

a. Three or more questions must be answered with a "3" or "4".

3. Task learning skills. To meet this category:

a. Three or more questions must be answered with a "3" or "4".

4. Personal care. To meet this category:

a. Question No. 1 must be answered with a "4" or "5", or

b. Question No. 2 must be answered with a "4" or "5", or

c. Questions No. 3 and 4 must be answered with a "4" or "5".

5. Mobility. To meet this category:

a. Any one question must be answered with a "4" or "5".

6. Behavior. To meet this category:

a. Any one question must be answered with a "3" or "4".

7. Community living. To meet this category:

a. Any two of the questions numbers 2, 5, or 7 must be answered with a "4" or "5", or

b. Three or more of questions 1 through 8 must be answered with a "4" or "5".

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.2 § 3, eff. December 26, 1985.

12VAC30-130-460 Directions for applying the criteria

A. The references under the questions in the following categories indicate those items which are on the Behavior Development Survey (DMH 71 Revised 6/80). The absence of a reference indicates this question is not addressed on the BDS form. Some categories on the Behavior Development Survey are not incorporated since the information in that area of the evaluation will be reflected elsewhere in the criteria or the condition is not indicative of a functional deficit justifying a need for intermediate care.

| PATIENT ASSESSMENT CRITERIA. | | | | | | | | | | | | | | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1. HEALTH STATUS -- To meet this category: | | | | | | | | | | | | | | | | | | | | | | | | | a. | Two or more questions must be answered with a 4, or Question No. 10 must be answered yes. | | | | | | | | | | | | | | | | | | | | | | | Rarely | Some- times | Often | Regu- larly | | | | | | | | | | | | | | | | | | | | | b. | How often is nursing care or nursing supervision by a licensed nurse required for the following: | 1 | 2 | 3 | 4 | | | | | | | | | | | | | | | | | | | | 1. | Medication administration and/or evaluation for effectiveness of a medication regime? ((70) Receiving Medications and History of Seizures pg.4) | 1 | 2 | 3 | 4 | | | | | | | | | | | | | | | | | | | 2. | Direct services: i.e., care for lesions, dressings, treatments, (other than shampoos, foot powder, etc.)? | 1 | 2 | 3 | 4 | | | | | | | | | | | | | | | | | | | 3. | Seizures control? ((68) History of seizures pg.4) | 1 | 2 | 3 | 4 | | | | | | | | | | | | | | | | | | | 4. | Teaching diagnosed disease control and care, including diabetes? | 1 | 2 | 3 | 4 | | | | | | | | | | | | | | | | | | | 5. | Management of care of diagnosed circulatory or respiratory problems? | 1 | 2 | 3 | 4 | | | | | | | | | | | | | | | | | | | 6. | Motor disabilities which interfere with all activities of daily living--bathing, dressing, mobility, toileting, etc.? | 1 | 2 | 3 | 4 | | | | | | | | | | | | | | | | | | | 7. | Observation for choking/aspiration while eating, drinking? | 1 | 2 | 3 | 4 | | | | | | | | | | | | | | | | | | | 8. | Supervision for use of adaptive equipment, i.e., special spoon, braces, etc.? (physical aids pg.4) | 1 | 2 | 3 | 4 | | | | | | | | | | | | | | | | | | | 9. | Observation for nutritional problems (i.e., undernourishment, swallowing difficulties, obesity)? | 1 | 2 | 3 | 4 | | | | | | | | | | | | | | | | | | | 10. | Is age 55 or older, has a diagnosis of a chronic disease and has been in an institution 20 years or more? | yes | no | | | | | | | | | | | | | | | | | | | 2. COMMUNICATION -- To meet this category: | | | | | | | | | | | | | | | | | | | | | | | | | a. | Three or more questions must be answered with a 3 or a 4. | | | | | | | | | | | | | | | | | | | | | | | No assis-tance | Prompt-ing/ Struc-turing | Super-vision | Some Direct Assis-tance | Total Assis-tance | | | | | | | | | | | | | | | | | | | | b. | How often does this person: | | | | | | | | | | | | | | | | | | | | | | | | 1. | Indicate wants by pointing, vocal noises, or signs? ((62)(c) Preverbal Expression pg.2) | 1 | 2 | 3 | 4 | | | | | | | | | | | | | | | | | | | 2. | Use simple words, phrases short sentences? ((67) Sentences pg.2) | 1 | 2 | 3 | 4 | | | | | | | | | | | | | | | | | | | 3. | Ask for at least ten things using appropriate names? ((67) Vocabulary pg.1) | 1 | 2 | 3 | 4 | | | | | | | | | | | | | | | | | | | 4. | Understand simple words, phrases or instructions containing prepositions: i.e., on in behind? ((27) Complex Instructions pg.3) | 1 | 2 | 3 | 4 | | | | | | | | | | | | | | | | | | | 5. | Speak in an easily understood manner? ((66) Speech pg.1) | 1 | 2 | 3 | 4 | | | | | | | | | | | | | | | | | | | 6. | Identify self, place of residence, and significant other, ((47) Awareness of Others, pg.3) | 1 | 2 | 3 | 4 | | | | | | | | | | | | | | | | | 3. TASK LEARNING SKILLS -- To meet this category: | | | | | | | | | | | | | | | | | | | | | | | | | a. | Three or more questions must be answered with a 3 or a 4. | | | | | | | | | | | | | | | | | | | | | | | Regu- larly | Often | Some-times | Rarely | | | | | | | | | | | | | | | | | | | | | b. | How often does this person: | | | | | | | | | | | | | | | | | | | | | | | | 1. | Pay attention to purposeful activities for 5 minutes? ((42)(2) Attention pg.3) | 1 | 2 | 3 | 4 | | | | | | | | | | | | | | | | | | | 2. | Stay with a three-step task for more than 15 mintues? ((42) (5) Attention pg. 3) | 1 | 2 | 3 | 4 | | | | | | | | | | | | | | | | | | | 3. | Tell time to the hour and understand time intervals? ((33) (b) Time pg. 3) | 1 | 2 | 3 | 4 | | | | | | | | | | | | | | | | | | | 4. | Count more than 10 objects? ((31) (5) Numbers pg.3) | 1 | 2 | 3 | 4 | | | | | | | | | | | | | | | | | | | 5. | Do simple addition, subtraction ((31) (6)Numbers pg.3) | 1 | 2 | 3 | 4 | | | | | | | | | | | | | | | | | | | 6. | Write or print ten words? ((59) (3) Writing pg. 2) | 1 | 2 | 3 | 4 | | | | | | | | | | | | | | | | | | | 7. | Discriminate shapes, sizes, or colors? | 1 | 2 | 3 | 4 | | | | | | | | | | | | | | | | | | | 8. | Name people or objects when describing pictures? ((67) (4) Vocabulary pg. 1) | 1 | 2 | 3 | 4 | | | | | | | | | | | | | | | | | | | 9. | Discriminate between one, many, lot? ((31) (2) Numbers pg. 3) | 1 | 2 | 3 | 4 | | | | | | | | | | | | | | | | | 4. PERSONAL/SELF CARE -- To meet this category: | | | | | | | | | | | | | | | | | | | | | | | | | a. | Question No. 1 must be answered with a 4 or a 5, or | | | | | | | | | | | | | | | | | | | | | | | b. | Question No. 2 must be answered with a 4 or a 5, or | | | | | | | | | | | | | | | | | | | | | | | c. | Questions No. 3 and 4 must be answered with a 4 or a 5? | | | | | | | | | | | | | | | | | | | | | | | NOTE: The yes or no questions are for the purpose of identification of needs to be included in the plan of care. Questions answered yes or no are not part of the scale. | | | | | | | | | | | | | | | | | | | | | | | | No Assis-tance | Prompt-ing/ Struc-turing | Super-vision | Some Direct Assis-tance | Total Assis-tance | | | | | | | | | | | | | | | | | | | | d. | With what type of assistance can this person currently: | | | | | | | | | | | | | | | | | | | | | | | | 1. | Perform toileting functions: i.e., maintain bladder and bowel continence, clean self? etc. ((31)(5) Toilet Training pg. 1) | 1 | 2 | 3 | 4 | 5 | | | | | | | | | | | | | | | | | | | (a) has toileting accidents more than twice a day? ((31)(2) Toilet Training pg. 1) | yes | | no | | | | | | | | | | | | | | | | | | | | | (b) has toileting accidents at night? | yes | | no | | | | | | | | | | | | | | | | | | | | | (c) Flushes toilet, pulls up clothes? ((36) Self Care at Toilet pg. 2) | yes | | no | | | | | | | | | | | | | | | | | | | | 2. | Perform eating/feeding functions: i.e., drinks liquids and eats with spoon or fork, etc? ((28)(3) Use of Table Utensils pg. 1) | 1 | 2 | 3 | 4 | 5 | | | | | | | | | | | | | | | | | | | (a) Feeds self with spoon neatly? ((28)(3) Use of Table Utensils) | yes | | no | | | | | | | | | | | | | | | | | | | | | (b) Spilling? ((3) (3) Drinking pg. 1) | yes | | no | | | | | | | | | | | | | | | | | | | | 3. | Perform bathing functions (i.e., bathe, runs bath, dry self, etc.)? ((44)(5) Bathing pg. 2) | 1 | 2 | 3 | 4 | 5 | | | | | | | | | | | | | | | | | | | (a) Washes hands and face with soap? ((39) (40) Washes Hands and Face pg. 2) | yes | | no | | | | | | | | | | | | | | | | | | | | | (b) Dries hands and face? ((42) Washes Hands and Face pg. 2) | yes | | no | | | | | | | | | | | | | | | | | | | | | (c) Care for hair, nails, beard? | yes | | no | | | | | | | | | | | | | | | | | | | | 4. | Dress self completely i.e., including fastening, putting on clothes, etc. ((5) (6) Dressing pg. 2) | 1 | 2 | 3 | 4 | 5 | | | | | | | | | | | | | | | | | | | (a) Dresses upper body, but needs help with fastening? | yes | | no | | | | | | | | | | | | | | | | | | | | | (b) Dresses self but needs assistance with pulling, or | yes | | no | | | | | | | | | | | | | | | | | | | | | (c) Putting on most clothing, fastening, shoes? ((50) (3) Dressing (52) Shoes pg. 2) | yes | | no | | | | | | | | | | | | | | | | | | 5. MOBILITY -- To meet this category: | | | | | | | | | | | | | | | | | | | | | | | | | a. | Any one question must be answered with a 4 or a 5. | | | | | | | | | | | | | | | | | | | | | | | NOTE: The yes or no questions are for the purpose of identification of needs to be included in the plan of care. Questions answered yes or no are not part of the scale. | | | | | | | | | | | | | | | | | | | | | | | | No Assis-tance | Prompt-ing/ Struc-turing | Super-vision | Some Direct Assis-tance | Total Assis-tance | | | | | | | | | | | | | | | | | | | | b. | With what type of assistance can this person currently: | | | | | | | | | | | | | | | | | | | | | | | | 1. | Move (walking, wheeling) around environment? ((59) Ambulation pg. 1,(79) Physical Aids pg. 4) | 1 | 2 | 3 | 4 | 5 | | | | | | | | | | | | | | | | | | | (a) Walk with assistive device, person? ((59) Ambulation pg. 1, Physical Aids pg. 4) | yes | | no | | | | | | | | | | | | | | | | | | | | | (b) Walk on level ground for 50 yards with or without assistive device? ((73, 74, 76) Physical Aids, pg. 4) | yes | | no | | | | | | | | | | | | | | | | | | | | | (c) Transfer to/from a wheelchair? ((75) Physical Aids pg. 4) | yes | | no | | | | | | | | | | | | | | | | | | | | 2. | Rise from lying down to sitting positions, sits without support? ((27) Body Balance pg. 1) | 1 | 2 | 3 | 4 | 5 | | | | | | | | | | | | | | | | | | 3. | Turn and position in bed, roll over? | 1 | 2 | 3 | 4 | 5 | | | | | | | | | | | | | | | | 6. BEHAVIOR -- To meet this category: | | | | | | | | | | | | | | | | | | | | | | | | | a. | Any one question must be answered with a 3 or a 4. | | | | | | | | | | | | | | | | | | | | | | | Rarely | Some-times | Often | Regu- larly | | | | | | | | | | | | | | | | | | | | | b. | How often does this person: | | | | | | | | | | | | | | | | | | | | | | | | 1. | Engage in self-destructive behavior? ((61) Maladaptive Behavior pg. 4) | 1 | 2 | 3 | 4 | | | | | | | | | | | | | | | | | | | 2. | Threaten or do physical violence to others? ((52) Maladaptive Behavior pg. 4) | 1 | 2 | 3 | 4 | | | | | | | | | | | | | | | | | | | 3. | Throw things, damage property, have temper outbursts? ((53, 55) Maladaptive Behavior pg. 4) | 1 | 2 | 3 | 4 | | | | | | | | | | | | | | | | | | | 4. | Respond to others in a socially unacceptable manner (without undue anger, frustration or hostility)? ((50) Interactions with Others pg. 3) | 1 | 2 | 3 | 4 | | | | | | | | | | | | | | | | | 7. COMMUNITY LIVING SKILLS -- To meet this category: | | | | | | | | | | | | | | | | | | | | | | | | | a. | Any two of questions 2, 5, or 7 must be answered with a 4 or a 5, or | | | | | | | | | | | | | | | | | | | | | | | b. | Three or more of questions 1 through 8 must be answered with a 4 or a 5. | | | | | | | | | | | | | | | | | | | | | | | No Assis-tance | Prompt-ing/ Struc-turing | Super-vision | Some Direct Assis-tance | Total Assis-tance | | | | | | | | | | | | | | | | | | | | c. | With what type of assistance would this person currently be able to: | | | | | | | | | | | | | | | | | | | | | | | | 1. | Prepare simple foods requiring no mixing or cooking? ((38) Food Preparation pg. 3) | 1 | 2 | 3 | 4 | 5 | | | | | | | | | | | | | | | | | | 2. | Take care of personal belongings, room (excluding vacuuming, ironing, clothes washing/drying, wet mopping)? ((43) Personal Belongings pg. 3) | 1 | 2 | 3 | 4 | 5 | | | | | | | | | | | | | | | | | | 3. | Add coins of various demonima1 nations up to one dollar? ((57) Money Handling pg. 2) | 1 | 2 | 3 | 4 | 5 | | | | | | | | | | | | | | | | | | 4. | Use the telephone to call home, doctor, fire, police? | 1 | 2 | 3 | 4 | 5 | | | | | | | | | | | | | | | | | | 5. | Recognize survival signs/words: i.e., stop, go, traffic lights, police, men, women, restrooms, danger, etc.? ((68) Reading pg. 2) | 1 | 2 | 3 | 4 | 5 | | | | | | | | | | | | | | | | | | 6. | Refrain from exhibiting unacceptable sexual behavior in public? ((63, 64, 65) Maladaptive Behavior pg. 4) | 1 | 2 | 3 | 4 | 5 | | | | | | | | | | | | | | | | | | 7. | Go around cottage, ward, building, without running away, wandering off, or becoming lost? ((56) Sense of Direction pg. 2, (57) Maladaptive Behavior pg. 4) | 1 | 2 | 3 | 4 | 5 | | | | | | | | | | | | | | | | | | 8. | Make minor purchases i.e., candy, soft drink, etc.? ((58, 4) Purchasing pg. 2) | 1 | 2 | 3 | 4 | 5 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.2 § 4, eff. December 26, 1985.

Part VII Hospice Services [Repealed]

12VAC30-130-470 (Repealed.)

Historical Notes

Derived from VR460-04-8.8 §§ 1 to 7, eff. July 3, 1991; repealed, Virginia Register Volume 16, Issue 6, eff. January 5, 2000.

Part VIII Community Mental Health and Mental Retardation Services

12VAC30-130-540 (Repealed.)

History

• Historical Notes: Derived from VR460-04-8.1500 § 1, eff. April 20, 1994; amended, Virginia Register Volume 14, Issue 7, eff. January 22, 1998; Volume 25, Issue 14, eff. April 15, 2009; repealed, Virginia Register Volume 33, Issue 12, eff. April 1, 2017.

12VAC30-130-550 (Repealed.)

Historical Notes

Derived from VR460-04-8.1500 § 2, eff. April 20, 1994; amended, Virginia Register Volume 14, Issue 7, eff. January 22, 1998; repealed, Virginia Register Volume 20, Issue 7, eff. February 1, 2004.

12VAC30-130-560 (Repealed.)

Historical Notes

Derived from VR460-04-8.1500 § 3, eff. April 20, 1994; repealed, Virginia Register Volume 14, Issue 7, eff. January 22, 1998.

12VAC30-130-565 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 14, Issue 7, eff. January 22, 1998; amended, Virginia Register Volume 20, Issue 7, eff. February 1, 2004; repealed, Virginia Register Volume 33, Issue 12, eff. April 1, 2017.

12VAC30-130-570 (Repealed.)

Historical Notes

Derived from VR460-04-8.1500 § 4, eff. April 20, 1994; amended, Virginia Register Volume 14, Issue 7, eff. January 22, 1998; repealed, Virginia Register Volume 20, Issue 7, eff. February 1, 2004.

12VAC30-130-580 (Repealed.)

History

• Historical Notes: Derived from VR460-04-8.1500 § 5, eff. April 20, 1994; repealed, Virginia Register Volume 33, Issue 12, eff. April 1, 2017.

12VAC30-130-590 (Repealed.)

History

• Historical Notes: Derived from VR460-04-8.1500 § 6, eff. April 20, 1994; repealed, Virginia Register Volume 33, Issue 12, eff. April 1, 2017.

Part IX DMAS-225 Adjustment Process

12VAC30-130-600 Definitions

The following words and terms, when used in this part, shall have the following meanings, unless the context indicates otherwise:

"DMAS" or "the department" means the Virginia Department of Medical Assistance Services.

"DMAS-225" means the Medicaid Communication form used for the provider and the DSS eligibility worker to report changes including requests for adjustments to the patient pay.

"DSS" means the local Department of Social Services.

"Facility" means a nursing facility, intermediate care facility for individuals with intellectual disabilities, or a long-stay acute care hospital enrolled in the Medicaid program.

"Medical necessity" means an item or service provided for the diagnosis or treatment of a patient's condition consistent with community standards of medical practice and in accordance with Medicaid policy.

"Preauthorization" means obtaining the approval necessary for receipt of a specified service from a specified provider for a specified recipient before the requested service is performed.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-04-8.16 § 1, eff. January 1, 1995; amended, Virginia Register Volume 37, Issue 26, eff. September 17, 2021; Volume 42, Issue 11, eff. February 11, 2026.

12VAC30-130-610 Purpose and scope

The department's payment to nursing facilities, intermediate care facilities for individuals with intellectual disabilities, and long-stay acute care hospitals shall be reduced by the amount of the patient's income, less certain deductions (the patient pay amount) in conformance with 42 CFR 435 (rev. October 1, 1992). Amounts for medical or remedial care not subject to payment by a third party, including necessary medical or remedial care not covered under the State Plan for Medical Assistance (the Plan), shall be deducted during the calculation of patient pay amounts.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-8.16 § 2, eff. January 1, 1995; amended, Virginia Register Volume 42, Issue 11, eff. February 11, 2026.

12VAC30-130-620 Limitations

A. A DMAS-225 adjustment request shall always be used as the last source of payment. If a recipient has other sources of possible payment (i.e., Medicare, major medical insurance, prescription insurance, dental insurance, etc.), payment must be sought first from those other sources.

B. The maximum amount for noncovered medically necessary items or services that can be allowed as adjustments to the patient pay amount for nursing facility residents shall be the amount specified in 12VAC30-40-235.

C. Only the cost of medically necessary, resident-specific, customized, noncovered items or services may be deducted from patient pay. This shall include, but not necessarily be limited to, electric, motorized, or customized wheelchairs and other equipment not regularly supplied to residents by the facility as part of the cost of care. Supplies, equipment, or services used in the direct care and treatment of residents are covered services and must be provided by the facility. Covered items and services include, but are not necessarily limited to, standard wheelchairs, recliners, geriatric chairs, special mattresses, humidifiers, cots, and routine podiatry care (e.g., trimming nails for onychauxis, cleaning and soaking the feet, and other services performed in the absence of localized illness, injury, or symptoms involving the foot). Expenses incurred by the facility for covered items and services are considered "allowable expenses" and are covered by Medicaid as part of reimbursement to the facility for the resident's care; these costs cannot be deducted from patient pay.

D. Extenuating circumstances shall be considered for the provision of podiatry care when corrective trimming is performed to prevent further complications in a patient who has a systemic condition that has resulted in severe circulation deficits or areas of desensitization in the legs or feet. Trimming of nails for a systemic condition is limited to once every 60 days and must be medically necessary. In such cases, the facility is not responsible for routine podiatry care.

E. DMAS-225 adjustments shall be allowed for the cost of medically or remedially necessary services provided prior to Medicaid eligibility or prior to admission. Any decision made by DMAS or DSS to deny a service may be appealed to DMAS. Appeals must be made in writing by the resident or his legally appointed representative, as provided for in DMAS Client Appeals Regulations (12VAC30-110).

F. The facility shall monitor the proper care of the resident's medical supplies and equipment. Requests for adjustment made because an item is lost or broken by facility staff must include documentation on the resident's interdisciplinary plan of care regarding proper care and treatment of the item. When loss or breakage is incurred as a result of facility staff following improper practices, the facility must replace the item.

G. All requests for DMAS-225 adjustments submitted by providers to either DMAS or DSS shall include:

1. The recipient's correct Medicaid identification number;

2. The current physician's orders for the noncovered service (not required for replacement of hearing aid batteries or eyeglass frames or for repair to hearing aids or eyeglasses);

3. Medical justification for the service being requested (see subsection H of this section);

4. The service description;

5. Actual cost information;

6. Documentation that the recipient continues to need the equipment for which a repair, replacement, or battery is requested;

7. A statement of proof of denial or noncoverage by other insurance; and

8. A copy of the most current, fully completed Minimum Data Set (MDS) and quarterly review.

H. Medical justification documentation as specified in subdivision G 3 of this section shall include the following:

1. Physician prescription;

2. Identification of the diagnosis related to the reason for the request;

3. Identification of the resident's functional limitation;

4. Identification of the quantity needed, frequency of use, estimated length of use; and

5. Identification of how the item or service will be used in the resident's environment.

I. Adjustments of a recipient's patient pay amount may only be authorized by DMAS or DSS.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-04-8.16 § 3, eff. January 1, 1995; amended, Virginia Register Volume 20, Issue 19, eff. August 1, 2004; Volume 37, Issue 26, eff. September 17, 2021.

Part X New Drug Review Program Regulations [Repealed]

12VAC30-130-630 (Repealed.)

Historical Notes

Derived from VR460-05-2000.000 §§ 1.1 through 2.4, eff. November 7, 1990; repealed, Virginia Register Volume 11, Issue 18, eff. July 1, 1995.

Part XI New Drugs Not Covered by Medicaid [Repealed]

12VAC30-130-730 (Repealed.)

Historical Notes

Derived from VR460-05-2000.1000, eff. February 1, 1990; repealed, Virginia Register Volume 11, Issue 18, eff. July 1, 1995.

Part XII Health Insurance Premium Payment Program (HIPP)

12VAC30-130-740 General

The requirements of this part shall operate in concert with the HIPP program requirements as contained in the State Plan for Medical Assistance, specifically Attachment 4.22-C (VR 460-02-4.2230).

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-4.2230 § 1, eff. April 1, 1993.

12VAC30-130-750 Time frames for determining cost effectiveness

A. The department (DMAS) shall determine eligibility for the program and shall provide notice to the recipient within 45 calendar days from the date of receiving an application that contains all information and verifications necessary to determine eligibility.

B. Incomplete applications shall be held for a period of 30 calendar days to enable applicants to provide outstanding information needed for an eligibility determination. Any applicant who fails to provide information or verifications necessary to determine eligibility within 30 calendar days of the receipt of the initial application shall have his application denied.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-4.2230 § 2, eff. April 1, 1993; amended, Virginia Register Volume 25, Issue 20, eff. July 23, 2009.

12VAC30-130-760 Notices

An adequate notice consistent with 42 CFR 431.210 shall be provided to the recipient, person carrying the group health plan policy or responsible person in the case under the following circumstances:

1. To inform the household of the decision on cost effectiveness and premium payment.

2. To inform the household that premium payments are being discontinued because Medicaid eligibility has been lost by all persons covered under the group health plan.

3. To inform the household that premium payments are being discontinued because the group health plan is no longer available to the family (e.g., the employer drops insurance coverage or the plan is terminated by the insurance company).

4. To inform the household that premium payments are being discontinued because DMAS has determined it is no longer cost effective to pay the premiums.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-4.2230 § 3, eff. April 1, 1993.

12VAC30-130-770 [Reserved]. (Reserved)

12VAC30-130-780 (Repealed.)

History

• Historical Notes: Derived from VR460-04-4.2230 § 5, eff. April 1, 1993; repealed, Virginia Register Volume 25, Issue 20, eff. July 23, 2009.

12VAC30-130-790 Information required of applicants and recipients

All applicants and recipients shall be required to provide the information required on the prescribed DMAS HIPP applications forms and all requested information to determine eligibility and cost effectiveness.

History

• Statutory Authority: §§32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from VR460-04-4.2230 § 6, eff. April 1, 1993; amended, Virginia Register Volume 25, Issue 20, eff. July 23, 2009.

Part XIII Client Medical Management Programs

12VAC30-130-800 Definitions

The following words and terms when used in this part shall have the following meanings unless the context clearly indicates otherwise:

"Abuse" or "abusive activities" means practices by individuals or providers that are inconsistent with sound fiscal or medical practices and result in unnecessary costs to the Virginia Medicaid program.

"Card-sharing" means (i) the intentional sharing of an individual's eligibility card for use by someone other than the individual for whom it was issued or (ii) unauthorized use of an individual's eligibility card by one or more persons other than the individual for whom it was issued due to the failure of the individual to safeguard the card.

"Client Medical Management Program for individuals" or "CMM Program for individuals" means the individuals' utilization control program designed to prevent abuse and promote improved and cost efficient medical management of essential health care for noninstitutionalized individuals through restriction to one primary care provider or one pharmacy, or any combination of these designated providers.

"Client Medical Management Program for providers" or "CMM Program for providers" means the providers' utilization control program designed to complement the individual abuse and utilization control program in promoting improved and cost efficient medical management of essential health care.

"Controlled substance" means a substance that has a potential for abuse because physical and psychic dependence and tolerance may develop upon repeated administration and that is classified as a Schedules I through V drug.

"Covering provider" means a provider designated by the primary provider to render health care services in the temporary absence of the primary provider.

"DMAS" or "the department" means the Department of Medical Assistance Services.

"Dental services" means covered dental services available to Medicaid or FAMIS eligible children as well as the limited, emergency services available to Medicaid eligible adults.

"Designated physician or pharmacy" means the provider who agrees to be the designated physician or pharmacy from whom the restricted individual must first attempt to seek medical or pharmaceutical services. Other providers may be established as designated physician or pharmacy providers with the approval of DMAS.

"Diagnosis" means (i) the process of determining by examination the nature and circumstances of a diseased condition or injury and (ii) the decision reached from such examination.

"Diagnostic category" means the broad classification of diseases and injuries found in the International Classification of Diseases (ICD), which is commonly used by providers in billing for medical services.

"Drug" means a substance or medication intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease as defined by the Virginia Drug Control Act (§ 54.1-3400 et seq. of the Code of Virginia).

"Duplicative medical care" means two or more practitioners are concurrently treating the same or similar medical problems or conditions falling into the same diagnostic category, but excluding confirmation for diagnosis, evaluation, or assessment.

"Duplicative medications" means more than one prescription of the same drug or more than one drug in the same therapeutic class.

"Education" means providing individuals with information regarding DMAS' identification of inappropriate utilization and what is appropriate access to Medicaid covered services according to the policies and procedures of the CMM Program for individuals and the CMM Program for providers. Education shall not include providing a professional opinion regarding an individual's medical or mental health.

"Eligibility card" means the document issued to each Medicaid individual listing the name and Medicaid number, either the identification or billing number, of the eligible individual, which may be in the form of a plastic card magnetically encoded, allowing electronic access to inquiries for eligibility status.

"Emergency hospital services" means those hospital services that are necessary to treat a medical emergency. Hospital treatment of a medical emergency necessitates the use of the most accessible hospital available that is equipped to furnish the required services.

"EPSDT" means the Early and Periodic Screening, Diagnosis, and Treatment Program that is federally mandated for eligible individuals younger than 21 years of age.

"Essential medical services" means quality medical services, including preventive care, emergency services, maternity care, hospital and physician services, and prescription drug services as set out in the State Plan for Medical Assistance.

"Excessive medical care" means obtaining greater than necessary services such that health risks to the individual or unnecessary costs to the Virginia Medicaid Program may ensue from the accumulation of services or obtaining duplicative services.

"Excessive medications" means obtaining medication in greater than generally acceptable maximum therapeutic dosage regimens or obtaining duplicative medication from one or more practitioners.

"FAMIS" means the Family Access to Medical Insurance Security program as created by Title XXI of the Social Security Act.

"Fraud" means an intentional deception or misrepresentation made by a person with the knowledge that the deception could result in some unauthorized benefit to himself or some other person. It includes any act that constitutes fraud under applicable federal or state laws.

"Health care" means any covered service, including equipment or supplies provided by any person, organization, or entity that participates in the Virginia Medical Assistance Program.

"Home and community-based services" means a range of community services approved by the Centers for Medicare and Medicaid Services (CMS) pursuant to § 1915(c) of the Social Security Act to be offered to individuals as an alternative to institutionalization.

"Hospice services" means services, pursuant to § 1905(o) of the Act, that are reasonable and necessary for the palliation or management of a terminal illness if the terminal illness runs its normal course.

"Immunization" means the creation of immunity against a particular disease using a vaccination.

"Individual" means the recipient of Medicaid-covered services that are provided under the authority of Titles XIX and XXI of the Social Security Act.

"Managed care organization" or "MCO" means an entity that meets the participation and solvency criteria defined in 42 CFR Part 438 and has an executed agreement with the department to provide services covered under (i) the Medallion II programs, pursuant to 12VAC30-120-360 et seq., or any successor programs and (ii) the FAMIS programs, pursuant to 12VAC30-141, or any successor programs.

"Medical emergency" means the sudden onset of a medical condition manifesting itself by acute symptoms of sufficient severity, including severe pain, that in the absence of immediate medical attention could reasonably be expected to result in (i) placing the individual's health in serious jeopardy, (ii) serious impairment of the individual's bodily functions, or (iii) serious dysfunction of the individual's bodily organs or parts.

"Medically necessary" means services that are reasonable and necessary for the diagnosis or treatment of an illness, condition, or injury, or to improve the function of a disability, consistent with community standards of medical practice and in accordance with Medicaid or FAMIS policies.

"Noncompliance" means failing to follow Client Medical Management Program policies and procedures, or a pattern of utilization that is inconsistent with sound fiscal or medical practices. Noncompliance includes failure to follow a recommended treatment plan or drug regimen; failure to disclose to a provider any treatment or services provided by another provider; or requests for medical services or medications that are not medically necessary.

"Pattern" means a combination of qualities, acts, or tendencies that result in duplication or frequent occurrence.

"Practitioner" means a health care provider licensed, registered, or otherwise permitted by law to distribute, dispense, prescribe, and administer drugs or otherwise treat medical conditions.

"Primary care provider" or "PCP" means a physician or nurse practitioner practicing in accordance with state law who is responsible for supervising, coordinating, and providing initial and primary medical care to patients; for initiating written referrals for specialist care; and for maintaining the continuity of patient care.

"Provider" means a person, organization, or institution with a current, valid license or certification, as applicable, and participation agreement with DMAS who or that will (i) render service to Medicaid individuals who are eligible for covered services, (ii) submit a claim or claims for the rendered services, and (iii) accept as payment in full the amount paid by the Virginia Medicaid or FAMIS program.

"Psychotropic drugs" means drugs that alter the mental activity, behavior, or perception. Examples of such drugs include morphine, barbiturates, hypnotics, antianxiety agents, antidepressants, and antipsychotics.

"Renal dialysis services" means services that aid the process of diffusing blood across a semi-permeable membrane to remove substances that a normal kidney would eliminate, including poisons, drugs, urea, uric acid, and creatinine. Renal dialysis services help to restore electrolytes and correct acid-base imbalances.

"Restrict" or "restriction" means an administrative action imposed on an individual that limits access to specific types of health care services through a designated primary provider or an administrative action imposed on a provider to prohibit participation as a designated primary provider, referral, or covering provider for restricted individuals.

"Social Security Act" or "the Act" means the statute, enacted by the 74th Congress on August 14, 1935, and as amended, that provides for the general welfare by establishing a system of federal old age benefits, and by enabling the states to make more adequate provisions for aged persons, blind persons, dependent children who have disabilities, maternal and child welfare, public health, and the administration of their unemployment compensation laws.

"State Plan for Medical Assistance" or "the Plan" means the comprehensive written statement submitted by the department to the Centers for Medicare and Medicaid Services (CMS) for approval describing the nature and scope of the Virginia Medicaid program and giving assurance that it will be administered in conformity with the requirements, standards, procedures, and conditions for obtaining federal financial participation.

"Therapeutic class" means a group of drugs with similar pharmacologic actions and uses.

"Under-use" or "under-utilization" means an occurrence where there is evidence that an individual did not receive a service or procedure whose benefits exceeded the risks.

"Utilization control" means the control of covered health care services to assure the use of cost efficient, medically necessary or appropriate services.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-04-8.3 § 1, eff. January 1, 1993; amended, Virginia Register Volume 14, Issue 10, eff. March 4, 1998; Volume 25, Issue 14, eff. April 15, 2009; Volume 32, Issue 4, eff. December 3, 2015; Volume 42, Issue 20, eff. June 17, 2026.

12VAC30-130-810 Client Medical Management Program for individuals

A. Purpose. The Client Medical Management Program for individuals is designed to assist and educate Medicaid individuals in appropriately using essential medical and pharmacy services. Individuals who use these services excessively or inappropriately as determined by DMAS may be assigned to a single primary care provider or pharmacy, or both. The CMM Program for individuals also monitors individual compliance with program guidelines.

B. Authority.

1. The Act and federal regulations at 42 CFR 456.3 require the Medicaid agency to implement a statewide surveillance and utilization control program that (i) safeguards against unnecessary or inappropriate use of Medicaid services and against excess payments, (ii) assesses the quality of those services, (iii) provides for the control of the utilization of all services provided under the Plan, and (iv) provides for the control of the utilization of inpatient services.

2. Federal regulations at 42 CFR 431.54(e) allow states to restrict individuals to designated providers when the individuals have utilized services at a frequency or an amount that is not medically necessary in accordance with utilization guidelines established by the state.

C. Identification of participants for inclusion in the CMM Program for individuals. DMAS shall identify individuals for review from computerized reports such as but not limited to individual Medicaid Enterprise System (MES), Oracle or by written referrals from agencies, health care professionals, or other persons. Certain individuals who are reviewed may not be restricted when evidence indicates that the prescription or medical service utilization patterns, or both, are for appropriate therapy. Only individuals who are excluded, pursuant to 12VAC30-120-370 B, from receiving care from a managed care organization shall be reviewed and evaluated for restriction under the CMM Program for individuals.

D. Individual evaluation for restriction.

1. DMAS shall utilize data as indicated in subsection C of this section to conduct a review of individuals to determine if services are being utilized at a frequency or amount that results in a level of utilization or a pattern of services which is not medically necessary or which are excessive medical services or excessive medications, or both, as established by the department. Evaluation of utilization patterns can include but is not limited to review by the department of medical records or computerized reports, or both, generated by the department reflecting claims submitted for physician visits, drugs or prescriptions, outpatient and emergency room visits, lab or diagnostic procedures, or both, and hospital admissions.

2. Restricted individuals shall have reasonable access to all essential medical services. These restrictions shall not apply to hospital emergency services.

3. Abusive activities shall be investigated and, if appropriate, the individual shall be reviewed for educational intervention or restriction, or both.

a. If DMAS' review determines that an individual's data indicates (i) inappropriate use of Medicaid services, (ii) questionable patterns of utilization, or (iii) unreasonable levelsof utilization, the department shall initiate the individual's restriction to either a physician or pharmacy, or both.

b. Once an individual is restricted, the restriction period shall last for 24 months from the enrollment date. During this restriction period, the individual shall be required to use the services of the designated physician or designated pharmacy, or both.

c. The individual may visit physicians or specialists other than those who are designated only by a written referral from the designated PCP.

d. The individual may obtain prescriptions from pharmacies other than the designated pharmacy only (i) in an emergency, (ii) when the designated pharmacy is closed, (iii) when the designated pharmacy does not stock the required medication, or (iv) when the designated pharmacy is not able to obtain the required medication in a timely manner.

E. Determination of restriction. DMAS may restrict an individual if any of the following activities or patterns or levels of utilization are identified. These activities, patterns, or levels of utilization include, for example:

1. Two occurrences of having prescriptions for the same drugs filled two or more times on the same or the subsequent day.

2. Utilizing services from three or more prescribers and three or more dispensing pharmacies in a three-month period.

3. Receiving more than 24 prescriptions in a three-month period.

4. Receiving more than 12 psychotropic prescriptions or more than 12 analgesic prescriptions or more than 12 prescriptions for controlled drugs with potential for abuse in a three-month period.

5. Exceeding the maximum therapeutic dosage of the same drug or multiple drugs in the same therapeutic class, which have been prescribed by two or more practitioners, for a period exceeding four weeks.

6. Receiving two or more drugs, duplicative in nature or potentially addictive (even within acceptable therapeutic levels), dispensed by more than one pharmacy or prescribed by more than one practitioner for a period exceeding four weeks.

7. Receiving narcotic prescriptions from two or more prescribers without supporting diagnoses indicative of use.

8. Utilizing three or more different physicians of the same type or specialty in a three-month period for treatment of the same or similar condition or conditions.

9. Two or more occurrences of seeing two or more physicians of the same type or specialty on the same or subsequent day for the same or similar diagnosis.

10. Duplicative, excessive, or contraindicated utilization of medications, medical supplies, or appliances dispensed by or prescribed by more than one provider for the time period specified by DMAS.

11. Use of emergency hospital services for three or more emergency room visits for nonemergency care during a three-month period.

12. One or more providers recommend restriction for medical management because the recipient has demonstrated inappropriate utilization practices.

13. A pattern of noncompliance that is inconsistent with sound fiscal or medical practices. For example, noncompliance may be characterized by:

a. Failure to disclose to a provider any treatment or services provided by another provider;

b. Failure to follow a drug regimen or other recommended treatment;

c. Requests for medical services or medications that are not medically necessary;

d. Use of hospital emergency services via self-referral for nonacute episodes of care or solely for nonacute management of the medical condition; or

e. Under-use or under-utilization of medically necessary services that results in higher costs for the management of the medical condition.

14. Any documented occurrences of use of the eligibility card to obtain drugs under false pretenses, which includes the purchase or attempt to purchase drugs via a forged or altered prescription.

15. Any documented occurrences of card-sharing.

16. Any documented occurrences of alteration of the recipient eligibility card.

17. One or more documented occurrences of paying cash for controlled substances, analgesic drugs, or psychotropic drugs in addition to the use of the eligibility card to obtain similar or duplicative controlled substances.

F. Individual restriction procedures.

1. DMAS shall advise affected individuals by written notice of the proposed restriction under the CMM Program for individuals. Written notice shall include an explanation of restriction procedures and the individual's right to appeal the proposed action.

2. The individual shall have the opportunity to select a designated physician or pharmacy, or both. If an individual fails to respond by the date specified in the restriction notice, DMAS shall select a designated physician or pharmacy, or both.

3. DMAS shall not implement restriction if a valid appeal, consistent with 12VAC30-110-210, is noted. (See subsection K of this section.)

4. DMAS shall restrict individuals to their designated physician or pharmacy, or both, for 24 months.

G. Designated providers.

1. A designated physician or pharmacy must be a provider that is enrolled in Virginia Medicaid and that is unrestricted by DMAS. Providers who are restricted pursuant to 12VAC30-130-820 D and E shall not serve as designated providers for restricted individuals and shall not serve as referral or covering providers for restricted individuals.

2. Physicians or pharmacy providers who are under the CMM Program for providers shall not serve as designated providers, shall not provide services through referral, and shall not serve as covering providers for restricted individuals.

3. Physicians with practices limited to the delivery of emergency room services may not serve as designated primary providers.

4. Other physicians or pharmacies may be established as designated providers as needed but only with the approval of DMAS.

H. Provider reimbursement.

1. DMAS shall reimburse for covered medical or pharmaceutical services, or both, and physician services for restricted individuals only when they are provided by the designated providers, or by physicians seen on a written referral from the designated PCP, or in a medical emergency consistent with the methodologies established for such services in the State Plan for Medical Assistance.

2. DMAS shall require a written referral, in accordance with published procedures, from the designated PCP for payment of covered outpatient services by nondesignated practitioners unless there is a medical emergency requiring immediate hospital treatment. Services exempt from these written referral requirements include:

a. Family planning services;

b. Annual or routine vision examinations for individuals under 21 years of age;

c. Dental services for individuals under 21 years of age;

d. Emergency services;

e. EPSDT well-child exams/screenings for individuals under 21 years of age;

f. Immunizations for individuals under 21 years of age;

g. Home and community-based care services such as private duty nursing or respite services;

h. Renal dialysis services;

i. Expanded prenatal services, including prenatal group education, nutrition services, and homemaker services for pregnant women and care coordination for high-risk pregnant women and infants up to two years of age; and

j. Hospice services.

3. Designated primary care providers (PCPs) shall receive a monthly case management fee for each assigned individual.

I. Changes in designated providers.

1. DMAS must give prior approval to all changes of designated providers.

2. The individual or the designated provider may initiate requests for change for the following reasons:

a. Relocation of the individual or provider.

b. Inability of the provider to meet the routine health or pharmaceutical needs of the individual.

c. Breakdown of the individual/provider relationship.

3. If the designated provider initiates the request and the individual does not select a new physician or pharmacy, or both, by established deadlines, DMAS shall select a provider, subject to concurrence from the provider or providers.

4. If DMAS denies the individual's request for a particular physician or pharmacy, or both, the individual shall be notified in writing and given the right to appeal the decision. (See subsection K of this section.)

J. Review of individual restriction status.

1. During the restriction period, DMAS shall monitor an individual's utilization no less frequently than every 12 months and follow up with the individual to promote appropriate utilization patterns.

2. DMAS shall also review an individual's utilization prior to the end of the restriction period to determine restriction termination or continuation.

a. DMAS shall extend utilization control restrictions for 12 months if any one of the following conditions is identified:

(1) The individual's utilization patterns include one or more conditions listed in subsection E of this section.

(2) The individual has not complied with procedures of the CMM Program for individuals resulting in services or medications received from any nondesignated provider, as demonstrated by his submitted claims, without a written referral or in the absence of a medical emergency.

(3) The individual has not complied with procedures of the CMM Program for individuals as demonstrated by a pattern of documented attempts to receive medications from any nondesignated pharmacy (i) in the absence of a medical emergency, (ii) when the designated pharmacy is closed, (iii) when the designated pharmacy does not stock the required medication, or (iv) when the designated pharmacy is unable to obtain the required medication in a timely manner.

(4) One or more of the designated providers recommends continued restriction status because the individual has demonstrated noncompliant behavior which is being controlled by restrictions within the CMM Program for individuals.

(5) Any changes of designated provider have been made due to the breakdown of the individual/provider relationship as a result of the individual's noncompliance.

b. DMAS shall notify the individual and designated physician or pharmacy, or both, in writing of the review decision. If restrictions are continued, written notice shall include the individual's right to appeal the proposed action. (See subsection K of this section.)

c. DMAS shall not implement the continued individual restriction if a valid appeal is noted pending the completion of the appeal action. Should the outcome of the appeal action support implementation of the restriction, the restriction shall be promptly implemented.

K. Individual appeals.

1. Individuals shall have the right to appeal any action, as defined in 42 CFR 431.201, that is taken by DMAS under this part.

2. Individual appeals shall be held pursuant to the provisions of Part I (12VAC30-110-10 et seq.) of 12VAC30-110, Eligibility and Appeals.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-04-8.3 § 2, eff. January 1, 1993; amended, Virginia Register Volume 14, Issue 10, eff. March 4, 1998; Volume 32, Issue 4, eff. December 3, 2015; Volume 42, Issue 20, eff. June 17, 2026.

12VAC30-130-820 Client Medical Management Program for providers

A. Purpose. The CMM Program for providers is a utilization control program designed to promote improved and cost-efficient medical management of essential health care.

B. Authority.

1. Federal regulations at 42 CFR 456.3 require the Medicaid agency to implement a statewide surveillance and utilization control program and at 42 CFR 455.1 through 455.16 require the Medicaid agency to conduct investigations of abuse by providers.

2. Federal regulations at 42 CFR 431.54(f) allow states to restrict providers' participation in the Medicaid program if the agency finds that providers of items or services under the State Plan have provided items or services at a frequency or amount not medically necessary in accordance with utilization guidelines established by the state or have provided items or services of a quality that do not meet professionally recognized standards of health care.

C. Identification of participants for inclusion in the CMM Program for providers. DMAS shall identify providers for review through computerized reports such as but not limited to Oracle, Medicaid Enterprise System (MES), or by written referrals from agencies, health care professionals, or other individuals.

D. Provider evaluation for restriction.

1. DMAS shall review providers to determine if health care services are being provided at a frequency or amount that is not medically necessary or that are not of a quality to meet professionally recognized standards of health care. Evaluation of utilization patterns can include review by the department of medical records or computerized reports generated by the department reflecting claims submitted for physician visits, drugs or prescriptions, outpatient and emergency room visits, lab or diagnostic procedures, hospital admissions, and referrals.

2. DMAS may restrict providers if any one or more of the following conditions is identified in a significant number or proportion of cases. These conditions include the following:

a. Visits billed at a frequency or level exceeding that which is medically necessary;

b. Diagnostic tests billed in excess of what is medically necessary;

c. Diagnostic tests billed which are unrelated to the diagnosis;

d. Medications prescribed or prescriptions dispensed in excess of recommended dosages;

e. Medications prescribed or prescriptions dispensed unrelated to the diagnosis; or

f. The provider's license to practice in any state has been revoked or suspended.

E. Provider restriction procedures.

1. DMAS shall advise affected providers by written notice of the proposed restriction under the CMM Program for providers. Written notice shall include an explanation of the basis for the decision, request for additional documentation, if any, and notification of the provider's right to appeal the proposed action.

2. DMAS shall restrict providers from being the designated provider, a referral provider, or a covering provider for individuals in the CMM Program for providers for 24 months.

3. DMAS shall notify the Centers for Medicare and Medicaid Services (CMS) and the general public of the restriction and its duration.

4. DMAS shall not implement provider restriction if a valid appeal is noted.

F. Review of provider restriction status.

1. DMAS shall review a restricted provider's claims history record prior to the end of the restriction period to determine restriction termination or continuation (See subsection D of this section). DMAS shall extend provider restriction for 24 months in one or more of the following situations:

a. Where abuse by the provider is identified.

b. Where the practices which led to restriction continue.

2. In cases where the provider has submitted an insufficient number of claims during the restriction period to enable DMAS to conduct a claims history review, DMAS shall continue restriction until a reviewable six-month claims history is available for evaluation.

3. If DMAS continues restriction following the review, the provider shall be notified of the agency's proposed action, the basis for the action, and appeal rights. (See subsection E of this section).

4. If the provider continues a pattern of inappropriate health care services, DMAS may make a referral to the appropriate peer review group or regulatory agency for recommendation and action as appropriate.

G. Provider appeals.

1. Providers shall have the right to appeal any action taken by the department under this part pursuant to § 32.1-325.1 of the Code of Virginia.

2. Provider appeals shall be held pursuant to the provisions of Article 3 (§ 2.2-4018 et seq.) of the Administrative Process Act.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from VR460-04-8.3 § 3, eff. January 1, 1993; amended, Virginia Register Volume 14, Issue 10, eff. March 4, 1998; Volume 25, Issue 14, eff. April 15, 2009; Volume 32, Issue 4, eff. December 3, 2015; Volume 42, Issue 20, eff. June 17, 2026.

Part XIV Residential Psychiatric Treatment for Children and Adolescents (Repealed)

12VAC30-130-850 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 17, Issue 5, eff. January 1, 2001; amended, Virginia Register Volume 33, Issue 12, eff. March 8, 2017; repealed, Virginia Register Volume 35, Issue 24, eff. August 22, 2019.

12VAC30-130-860 (Repealed.)

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 5, eff. January 1, 2001; amended, Virginia Register Volume 22, Issue 8, eff. January 25, 2006; repealed, Virginia Register Volume 35, Issue 24, eff. August 22, 2019.

12VAC30-130-870 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 17, Issue 5, eff. January 1, 2001; amended, Virginia Register Volume 22, Issue 8, eff. January 25, 2006; repealed, Virginia Register Volume 35, Issue 24, eff. August 22, 2019.

12VAC30-130-880 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 17, Issue 5, eff. January 1, 2001; Errata, 17:6 VA.R. 932 December 4, 2000; amended, Virginia Register Volume 22, Issue 8, eff. January 25, 2006; repealed, Virginia Register Volume 35, Issue 24, eff. August 22, 2019.

12VAC30-130-890 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 17, Issue 5, eff. January 1, 2001; amended, Virginia Register Volume 22, Issue 8, eff. January 25, 2006; Volume 25, Issue 14, eff. April 15, 2009; Volume 33, Issue 12, eff. March 8, 2017; repealed, Virginia Register Volume 35, Issue 24, eff. August 22, 2019.

Part XV Case Management Treatment Foster Care Services

12VAC30-130-900 Definitions

The following words and terms when used in this part shall have the following meanings unless the context indicates otherwise:

"Case management" means an activity that assists Medicaid eligibles in gaining and coordinating access to necessary care and services appropriate to his needs.

"Child" means any individual less than 18 years of age or under 21 if placed by a local department of social services or through referral from a Family Assessment and Planning Team.

"Child's family" means the birth or adoptive parent or parents, legal guardian or guardians, or family to whom the child may return.

"Child placing agency," "agency" or "agencies" means any person who places children in foster homes, adoptive homes, child-caring institutions or independent living arrangements in response to §§ 63.1-204, 63.1-205, and 63.1-219.28 of the Code of Virginia or a local board of public welfare or social services that places children in foster homes or adoptive homes pursuant to §§ 63.1-56, 63.1-204, and 63.1-219.28 of the Code of Virginia. Officers, employees, or agents of the Commonwealth, or of any county, city, or town, acting within the scope of their authority as such, who serve as or maintain a child-placing agency shall not be required to be licensed if authorized by the Code of Virginia to provide the services of a child-placing agency.

"Client" means Medicaid-eligible and enrolled individual.

"Community Planning and Management Team" means a team described in § 2.1-750 of the Code of Virginia.

"Comprehensive Services Act" means § 2.1-745 et seq. of the Code of Virginia.

"Department" or "DMAS" means the Department of Medical Assistance Services.

"Family Assessment and Planning Team" means a team described in §§ 2.1-753, 2.1-754, and 2.1-755 of the Code of Virginia.

"Foster care placement" means placement of a child through (i) an agreement between the parents or guardians and the local board or the public agency designated by the community policy and management team where legal custody remains with the parents or guardians or (ii) an entrustment or commitment of the child to the local board or child-placing agency.

"Foster care services" means the provision of a full range of casework, treatment and community services for a planned period of time to a child under age 21 who is abused or neglected as defined, except for age, in § 63.1-248.2 of the Code of Virginia or in need of services as defined in § 16.1-228 of the Code of Virginia and to his family when the child (i) has been identified as needing services to prevent or eliminate the need for foster care placement, (ii) has been placed through an agreement between the local board of social services or the public agency designated by the community policy and management team and the parents or guardians, and (iii) has been committed or entrusted to a local board of social services or child-placing agency.

"Foster home" means the place of residence of any individual or individuals approved by a local department of social services or licensed child placing agency in which any child other than a child by birth or adoption resides as a member of the household.

"Initial plan of care" means a written plan that delineates the services that are to be provided to the child at admission.

"Records" means the written information assembled in a file relating to the agency, staff, volunteers, the child, the child's birth family, the child's foster family, the child's treatment foster family, and the child's adoptive family.

"Treatment" is the coordinated provision of services and use of professionally developed and supervised interventions designed to produce a planned outcome in a person's behavior, attitude, emotional functioning or general condition.

"Treatment and service plan" means a written comprehensive plan of care, based on an assessment of the medical, psychological, social, behavioral and developmental aspects of the child's situation, containing measurable goals, procedures and interventions for achieving them, and a process for assessing the results. The treatment plan must state the treatment objectives; prescribe an integrated program of therapies, activities, and experiences designed to meet the objectives; and must include coordination with related community services to ensure continuity of care with the child's family, school and community.

"Treatment foster care (TFC)" means a community-based program where services are designed to address the special needs of children. Services to the children are delivered primarily by treatment foster parents who are trained, supervised, and supported by agency staff. Treatment is primarily foster family based and is planned and delivered by a treatment team.

Treatment foster care focuses on a continuity of services, is goal-directed and results oriented, and emphasizes permanency planning for the child in care.

"Treatment team" means the group that may consist of the child, professional agency staff, other professionals, the child's family members (where appropriate), and the child-placing agency and treatment foster parents who provide mutual support, evaluate treatment, and design, implement and revise the treatment and service plan.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 5, eff. January 1, 2001; amended, Virginia Register Volume 23, Issue 12, eff. March 21, 2007.

12VAC30-130-910 Targeted case management for foster care children in treatment foster care (TFC) covered services

Service description. Case management is a component of TFC through which a case manager monitors the treatment plan and links the child to other community resources as necessary to address the special identified needs of the child. Services to the children shall be delivered primarily by treatment foster parents who are trained, supervised and supported by professional child-placing agency staff. TFC case management focuses on a continuity of services, is goal directed and results oriented. Services shall not include room and board. The following activities are considered covered services related to TFC case management services:

1. Care planning, monitoring of the plan of care, and discharge planning;

2. Case management; and

3. Evaluation of the effectiveness of the child's plan of treatment.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 5, eff. January 1, 2001; amended, Virginia Register Volume 23, Issue 12, eff. March 21, 2007; Volume 25, Issue 14, eff. April 15, 2009.

12VAC30-130-920 Provider qualifications

A. License or certification. Treatment foster care case management shall be provided by child-placing agencies with treatment foster care programs that are licensed or certified by the Virginia Department of Social Services to be in compliance with the Minimum Standards for Licensed Child-Placing Agencies (22VAC40-130-10 et seq.) and meet the provider qualifications for treatment foster care set forth in this part.

B. Caseload size.

1. The treatment foster care case manager shall have a maximum of 12 children in his caseload for a full-time professional staff person. The caseload shall be adjusted downward if:

a. The caseworker's job responsibilities exceed those listed in the agency's job description for a caseworker, as determined by the supervisor; or

b. The difficulty of the client population served requires more intensive supervision and training of the treatment foster parents.

c. Exception: A caseworker may have a maximum caseload of 15 children as long as not more than 10 of the children are in treatment foster care and the above criteria for adjusting the caseload downward do not apply.

2. There shall be a maximum of six children in the caseload for a beginning trainee that may be increased to nine by the end of the first year and 12 by the end of the second year.

3. There shall be a maximum of three children in a caseload for a student intern if any student intern works in the agency.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 5, eff. January 1, 2001.

12VAC30-130-930 Organization and administration requirements

A. These standards shall be met by any enrolled provider signing an agreement with DMAS to provide case management services to children in treatment foster care.

B. A Medicaid enrolled treatment foster care case management provider must be licensed by the Department of Social Services (DSS) as a child-placing agency with treatment foster care as defined in this part or shall be certified by DSS as designated by DMAS to meet all the requirements of this part. Officers, employees, or agents of the Commonwealth, or of any county, city, or town acting within the scope of their authority as such, who serve as or maintain a child-placing agency shall not be required to be licensed but shall be required to be certified to meet all the requirements of this part by the DSS.

C. Treatment and service plans in treatment foster care.

1. The treatment foster care case management provider shall prepare and implement an individualized treatment and service plan for each child in its care. When available, the parents shall be consulted unless parental rights have been terminated. If the parents cannot be consulted, the agency shall document the reason in the child's record.

2. When the treatment foster care case management provider holds custody of the child, a service plan shall be filed with the court within 60 days after the agency receives custody unless the court grants an additional 60 days, or the child is returned home or placed for adoption within 60 days. Providers with legal custody of the child shall follow the requirements of §§ 16.1-281 and 16.1-282 of the Code of Virginia.

3. The permanency planning goals and the requirements and procedures in the Department of Social Services Service Programs Manual, Volume VII, Section III, Chapter B, "Preparing the Initial Service Plan" may be consulted.

4. The initial plan of care for services to the child must be developed within two weeks of placement.

5. Comprehensive treatment and service plan. The case manager and other designated child-placing agency staff shall develop and implement for each child in care an individualized comprehensive treatment and service plan within the first 45 days of placement that shall include:

a. A comprehensive assessment of the child's emotional, behavioral, educational, nutritional, and medical needs;

b. The treatment goals and objectives including the child's specific problems, behaviors and skills to be addressed, the criteria for achievement and target dates for each goal and objective;

c. The treatment foster care case management provider's program of therapies, activities and services, including the specific methods of intervention and strategies designed to meet the above goals and objectives, and describing how the provider is working with related community resources, including the child's primary care physician, to provide a continuity of care;

d. The discharge goals and objectives, services to be provided for their achievement, and plans for reunification of the child and the child's family, where appropriate. Unless specifically prohibited by court order, foster children shall have access to regular contact with their families.

e. The target date for discharge from treatment foster care case management;

f. For children age 16 and over, the plan shall include a description of the programs and services that will help the child transition from foster care to independent living; and

g. The dated signature of the case manager and the identity of all members of the treatment team that participated in the plan's development.

6. The case manager shall include and work with the child, the custodial agency, the treatment foster parents and the parents, where appropriate, in the development of the treatment and service plan and a copy shall be provided to the custodial agency. A copy shall be provided to the treatment foster parents as long as confidential information about the child's birth family is not revealed. A copy shall be provided to the parents, if appropriate, as long as confidential information about the treatment foster parents is not revealed. If any of these parties do not participate in the development of the treatment and service plan, the case manager shall document the reasons in the child's record.

7. The case manager shall provide support and guidance to foster families in implementing the treatment and service plan for the child.

D. Progress report and ongoing services plans.

1. The case manager shall complete written progress reports beginning 90 days after the date of the child's placement and every 90 days thereafter.

2. The progress report shall specify the time period covered and include:

a. Progress on the child's specific problems and behaviors and any changes in the methods of intervention and strategies to be implemented:

(1) Description of the treatment goals and objectives met, goals and objectives to be continued or added, the criteria for achievement and target dates for each goal and objective;

(2) Description of the therapies, activities, and services provided during the previous 90 days toward the treatment goals and objectives; and

(3) Any changes needed for the next 90 days;

b. Services provided during the last 90 days towards the discharge goals, any changes in these goals, the criteria for achievement and target dates for each goal and objective, and services to be provided during the next 90 days;

c. The child's assessment of his progress and his description of services needed, where appropriate;

d. Contacts between the child and the child's family, where appropriate;

e. Medical needs, specifying medical treatment provided and still needed and medications provided;

f. An update to the discharge plans, including the projected discharge date; and

g. A description of the programs and services provided to children ages 16 and older to help the child transition from foster care to independent living, where appropriate.

3. Annually, the progress report shall address the above requirements as well as evaluate and update the comprehensive treatment and service plan for the upcoming year.

4. The case manager shall date and sign each progress report.

5. The case manager shall include each child who has the ability to understand in the preparation of the child's treatment and service plans and progress reports or document the reasons this was not possible. The child's comments shall be recorded in the report.

6. The case manager shall include and work with the child, the treatment foster parents, the custodial agency and the parents, where appropriate, in the development of the progress report. A copy shall be provided to the placing agency worker and, if appropriate, to the treatment foster parents.

E. Contacts with child.

1. There shall be face-to-face contact between the case manager and the child, based upon the child's treatment and service plan and as often as necessary to ensure that the child is receiving safe and effective services.

2. Face-to-face contacts shall be no less than twice a month, one of which shall be in the foster home. One of the contacts shall include the child and at least one treatment foster parent and shall assess the relationship between the child and the treatment foster parents.

3. The contacts shall assess the child's progress, provide training and guidance to the treatment foster parents, monitor service delivery, and allow the child to communicate concerns.

4. A description of all contacts shall be documented in the narrative.

5. Children who are able to communicate shall be interviewed privately at least once a month.

6. Unless specifically prohibited by court or custodial agency, foster children shall have access to regular contact with their families as described in the treatment and service plan.

7. The case manager shall work actively to support and enhance child/family relationships and work directly with the child's family toward discharge as specified in the treatment and service plan.

8. The case manager shall record all medications prescribed for each child and all reported side effects or adverse reactions.

F. Professional clinical or consultative services. In consultation with the custodial agency, the case manager or caseworker shall provide or arrange for a child to receive psychiatric, psychological, and other clinical services if the need for them has been recommended or identified.

G. Narratives in the child's record. Narratives shall be in chronological order and current within 30 days. Narratives shall include areas specified in this part and shall cover:

1. Treatment and services provided;

2. All contacts related to the child;

3. Visitation between the child and the child's family; and

4. Other significant events.

H. Treatment teams in treatment foster care.

1. The treatment foster care case management provider shall ensure that a professional staff person provides leadership to the treatment team that includes:

a. Managing team decision making regarding the care and treatment of the child and services to the child's family;

b. Providing information and training as needed to treatment team members; and

c. Involving the child and the child's family in treatment team meetings, plans, and decisions, and keeping them informed of the child's progress, whenever possible.

2. Treatment team members shall consult as often as necessary, but at least on a quarterly basis.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 5, eff. January 1, 2001; amended, Virginia Register Volume 23, Issue 12, eff. March 21, 2007.

12VAC30-130-940 Discharge from care

A. A discharge summary shall be developed for each child and placed in the child's record within 30 days of discharge. It shall include the date of and reason for discharge, the name of the person with whom the child was placed or to whom he was discharged, and a description of the services provided to the child and progress made while the child was in care. Written recommendations for aftercare shall be made for each child prior to the child's discharge. Such recommendations shall specify the nature, frequency, and duration of aftercare services to be provided to the child and the child's family.

B. The summary shall also include an evaluation of the progress made toward the child's treatment goals.

C. Discharge planning shall be developed with the treatment team and with the child, the child's parents or guardian, and the custodial agency.

D. Children in the custody of a local department of social services or private child-placing agency shall not be discharged without the knowledge, consultation, and notification of the custodial agency.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 5, eff. January 1, 2001.

12VAC30-130-950 Entries in case records

All entries shall be dated and shall identify the individual who performed the service. If a treatment foster care case management provider has offices in more than one location, the record shall identify the office that provided the service. Each child's record shall contain documentation that verifies the services rendered for billing.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 17, Issue 5, eff. January 1, 2001.

Part XVI Pharmacy Services Prior Authorization

12VAC30-130-1000 Pharmacy services prior authorization

A. Definitions. The following words and terms used in this part shall have the following meanings unless the context clearly indicates otherwise:

"Contractor" means an independent contractor that implements and administers, pursuant to its contract, the department's pharmacy prior authorization programs as set out in the Title XIX State Plan.

"Grandfather clause" means procedure by which selected therapeutic classes or drugs as designated by the P&T Committee may be automatically approved if the patient is currently and appropriately receiving the drug.

"Pharmacy and Therapeutics Committee," "P&T Committee," or "committee" means the committee formulated to review therapeutic classes, conduct clinical reviews of specific drugs, recommend additions or deletions to the preferred drug list, and perform other functions as required by the department. The Pharmacy and Therapeutics Committee shall be composed of eight to 12 members, including the Commissioner of the Department of Behavioral Health and Developmental Services, or the commissioner's designee. Other members shall be selected or approved by the department. The membership shall include a ratio of physicians to pharmacists of 2:1. Physicians on the committee shall be licensed in Virginia, one of whom shall be a psychiatrist, and one of whom specializes in care for the aging. Pharmacists on the committee shall be licensed in Virginia, one of whom shall have clinical expertise in mental health drugs, and one of whom has clinical expertise in community-based mental health treatment.

B. DMAS shall operate, in conjunction with the Title XIX State Plan for Medical Assistance (12VAC30-50-210 et seq.), a program of prior authorization of pharmacy services. This program shall include the use of a preferred drug list.

C. Medicaid Pharmacy and Therapeutics Committee.

1. The department shall utilize a Pharmacy and Therapeutics Committee to assist in the development and ongoing administration of the preferred drug list and other pharmacy program issues. The committee may adopt bylaws that set out its make up and functioning. A quorum for action of the committee shall consist of seven members.

2. Vacancies on the committee shall be filled in the same manner as original appointments. The department shall appoint individuals for the committee that assures a cross-section of the physician and pharmacy community.

3. Duties of the committee.

a. The committee shall receive and review clinical and pricing data related to the drug classes. The committee's medical and pharmacy experts shall make recommendations to DMAS regarding various aspects of the pharmacy program. For the PDL program, the committee shall select those drugs to be deemed preferred that are safe and clinically effective, as supported by available clinical data, and meet pricing standards.

b. Cost effectiveness or any pricing standard shall be considered only after a drug is determined to be safe and clinically effective. The committee shall recommend to the department:

(1) Which therapeutic classes of drugs should be subject to the preferred drug list program and prior authorization requirements;

(2) Specific drugs within each therapeutic class to be included on the preferred drug list;

(3) Appropriate exclusions for medications, including atypical anti-psychotics, used for the treatment of serious mental illnesses such as bipolar disorders, schizophrenia, and depression;

(4) Appropriate exclusions for medications used for the treatment of certain brain disorders, cancer, and HIV-related conditions;

(5) Appropriate exclusions for therapeutic classes in which there is only one drug in the therapeutic class or there is very low utilization, or for which it is not cost effective to include in the preferred drug list program;

(6) Appropriate grandfather clauses when prior authorization would interfere with established complex drug regimens that have proven to be clinically effective;

(7) Other clinical criteria that may be included in the pharmacy program; and

(8) Guidance and recommendations regarding the department's pharmacy programs.

c. As the U.S. Food and Drug Administration (FDA) approves new drug products, the department shall ensure that the Pharmacy and Therapeutics Committee will evaluate the drug for clinical effectiveness and safety. Based on clinical information and pricing standards, the P&T Committee will determine if the drug will be included in the PDL or require prior authorization.

(1) If the new drug product falls within a drug class previously reviewed by the P&T Committee, until the review of the new legend drug is completed, it will be classified as nonpreferred, requiring prior authorization in order to be dispensed. The new legend drug will be evaluated for inclusion in the PDL no later than at the next review of the drug class.

(2) If the new drug product does not fall within a drug class previously reviewed by the P&T Committee, the new drug shall be treated in the same manner as the other drugs in its class.

d. To the extent feasible, the P&T Committee shall review all drug classes included in the PDL at least every 12 months and may recommend additions to and deletions from the PDL.

D. Pharmacy contractor. The department may contract for pharmaceutical benefit management services to manage, implement, and administer the Medicaid pharmacy benefits preferred drug list, as directed, authorized, and as may be amended from time to time, by DMAS.

1. The department, as the sole Title XIX authority for the Commonwealth, shall retain final administrative authority over all pharmacy services.

2. The department shall not offer or pay directly or indirectly any material inducement, bonus, or other financial incentive to a program contractor based on the denial or administrative delay of medically appropriate prescription drug therapy, or on the decreased use of a particular drug or class of drugs, or a reduction in the proportion of beneficiaries who receive prescription drug therapy under the Medicaid program. Bonuses shall not be based on the percentage of cost savings generated under the benefit management of services.

E. Supplemental rebates. The department shall have the authority to seek supplemental rebates from drug manufacturers. The contract regarding supplemental rebates shall exist between the manufacturer and the Commonwealth. Rebate agreements between the Commonwealth and a pharmaceutical manufacturer shall be separate from the federal rebates and in compliance with federal law, §§ 1927(a)(1) and 1927(a)(4) of the Social Security Act. All rebates collected on behalf of the Commonwealth shall be collected for the sole benefit of the state share of costs. One hundred percent of the supplemental rebates collected on behalf of the state shall be remitted to the state. Supplemental drug rebates received by the Commonwealth in excess of those required under the national drug rebate agreement will be shared with the federal government on the same percentage basis as applied under the national drug rebate agreement.

F. Appeals. The department shall provide an expedient reconsideration process and initiate and fully participate in the DMAS appeal process pursuant to 12VAC30-110, Part I, Client Appeals, for providers and recipients.

G. Annual report. The department shall report to the Governor and the Chairmen of the House Appropriations and Senate Finance Committees on an annual basis.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia; Item 325 ZZ of Chapter 1042 of the 2003 Acts of Assembly.
• Historical Notes: Derived from Virginia Register Volume 21, Issue 6, eff. January 3, 2005; amended, Virginia Register Volume 42, Issue 11, eff. February 11, 2026.

Part XVII Marketing of Provider Services

12VAC30-130-2000 Marketing requirements and restrictions

A. Purpose. The purpose of these rules shall be to define how providers shall be permitted to market their services to potential Medicaid or FAMIS beneficiaries and individuals who may or may not be currently enrolled with the particular provider. This shall apply to providers of community mental health services (12VAC30-50-226) and Early and Periodic Screening, Diagnosis, and Treatment Program (EPSDT) community mental health services (12VAC30-50-130) with the exception of Part C services.

B. Definitions.

"Beneficiaries" means individuals of any age and their families who are using or who may use community mental health rehabilitative services.

"DMAS" means the Department of Medical Assistance Services.

"FAMIS" means Family Access to Medical Insurance Security.

"Marketing materials" means any material created to promote services through any media including written materials, television, radio, websites, and social media.

"Provider" means an individual or organizational entity that is appropriately licensed as required and enrolled as a DMAS provider of community mental health and substance abuse services.

C. Requirements.

1. Marketing and promotional activities (including provider promotional activities) shall comply with all applicable federal and state laws.

2. Providers shall provide clearly written materials that completely and accurately describe the Medicaid or FAMIS behavioral health services offered, the beneficiary eligibility requirements to receive the services, applicable fees and other charges, and all other information required for beneficiaries and their families to make fully informed decisions about enrollment into the services offered by the provider that is marketing its services.

3. Providers shall distribute their marketing materials only in the service locations approved within the license issued by the Licensing Division of the Department of Behavioral Health and Developmental Services.

D. Limits and prohibitions.

1. Providers shall not offer cash or noncash incentives to their enrolled or prospective members for the purposes of marketing, retaining beneficiaries within the providers' services, or rewarding behavior changes in compliance with goals and objectives stated in beneficiaries' individual service plans.

2. While engaging in marketing activities, providers shall not:

a. Engage in any marketing activities that could misrepresent the service or DMAS;

b. Assert or state that the beneficiary must enroll with the provider in order to prevent the loss of Medicaid or FAMIS benefits;

c. Conduct door-to-door, telephone, unsolicited school presentations, or other cold call marketing directed at potential or current beneficiaries;

d. Conduct any marketing activities or use marketing materials that are not specifically approved by DMAS;

e. Make home visits for direct or indirect marketing or enrollment activities except when specifically requested by the beneficiary or family;

f. Collect or use Medicaid or FAMIS confidential information or Medicaid or FAMIS protected health information (PHI), as that term is defined in Health Insurance Portability and Accountability Act of 1996 (HIPAA), that may be either provided by another entity or obtained by marketing provider, to identify and market services to prospective beneficiaries;

g. Violate the confidential information or confidentiality of PHI by sharing or selling lists of information about beneficiaries for any purposes other than the performance of the provider's obligations relative to its DMAS provider agreement;

h. Contact, after the effective date of disenrollment, beneficiaries who choose to disenroll from the provider except as may be specifically required by DMAS;

i. Conduct service assessment or enrollment activities at any marketing or community event; or

j. Assert or state (either orally or in writing) that the provider is endorsed either by the Centers for Medicare and Medicaid Services, DMAS, or any other federal or state governmental entities.

E. Termination. Providers that (i) violate any of the prohibitions in this section or (ii) fail to meet requirements shall be subject to termination of their provider agreements for the services affected by the marketing plan or activity. Providers whose contracts are terminated shall be afforded the right of appeal pursuant to the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

History

• Statutory Authority: §32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 31, Issue 9, eff. January 30, 2015; amended, Virginia Register Volume 35, Issue 22, eff. August 8, 2019.

12VAC30-130-3000 (Repealed.)

(Repeal)

History

• Historical Notes: Derived from Virginia Register Volume 31, Issue 9, eff. January 30, 2015; repealed, Virginia Register Volume 35, Issue 10, eff. February 21, 2019.

12VAC30-130-3010 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 31, Issue 9, eff. January 30, 2015; repealed, Virginia Register Volume 35, Issue 10, eff. February 21, 2019.

12VAC30-130-3020 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 31, Issue 9, eff. January 30, 2015; repealed, Virginia Register Volume 35, Issue 10, eff. February 21, 2019.

12VAC30-130-3030 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 31, Issue 9, eff. January 30, 2015; repealed, Virginia Register Volume 35, Issue 10, eff. February 21, 2019.

Part XVIII Consumer-Directed Attendants

12VAC30-130-3040 Definitions

The following words and terms when used in this part shall have the following meanings unless the context clearly indicates otherwise:

"Consumer-directed attendant" or "CD attendant" means a person who provides, via the consumer-directed model of services, personal care, companion services, or respite care, or any combination of these three services. "Consumer-directed" or "CD" means the model of service delivery under which the individual enrolled in the waiver or benefit program or the individual's employer of record, as appropriate, is responsible for hiring, training, supervising, and firing of the attendants who render the services that are reimbursed by DMAS.

"DMAS" means the Department of Medical Assistance Services.

"Employer of record" or "EOR" means the person who performs the functions of the employer in the consumer-directed model of service delivery. The EOR may be the individual enrolled in the waiver or benefit program, a family member, caregiver, or another person.

"Fiscal or employer agent" or "FEA" means a state agency or other entity as determined by DMAS that meets the requirements of 42 CFR 441.484.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 14, eff. April 10, 2025.

12VAC30-130-3050 Scope

A. The paid sick leave benefit for consumer-directed attendants applies to any CD attendant who meets the eligibility requirements at 12VAC30-130-3060 A 2, consistent with the requirements of Article 2.1 (§ 40.1-33.3 et seq.) of Chapter 3 of Title 40.1 of the Code of Virginia.

B. The paid sick leave benefit shall only apply to CD attendants who perform consumer-directed services in accordance with the requirements under the following programs or waivers:

1. Early Periodic Screening, Diagnostic, and Treatment benefit program (12VAC30-50-130);

2. Medicaid Works benefit program (12VAC30-60-200);

3. Commonwealth Coordinated Care Plus Waiver (Part X (12VAC30-120-900 et seq.) of 12VAC30-120);

4. Community Living Waiver (12VAC30-122-250); or

5. Family and Individual Support Waiver (12VAC30-122-260).

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 14, eff. April 10, 2025.

12VAC30-130-3060 Eligibility and Use

A. The FEA shall have the responsibility of determining eligibility for paid sick leave each state fiscal year quarter.

1. A CD attendant shall be determined eligible to earn paid sick leave based on a quarterly evaluation of the CD attendant's hours worked for the EOR.

2. The FEA shall calculate the average number of hours the CD attendant worked for the EOR during the quarter. CD attendants who work an average of 20 hours per week or at least 90 hours per month for the quarter shall be eligible to earn paid sick leave.

3. Work shift entries shall be submitted by the CD attendant and approved by the EOR within 20 days of the end of the preceding quarter in order to be included in the eligibility determination.

B. The FEA shall have the responsibility of documenting the accrual and use of sick leave hours by the CD attendant. The benefit shall be available to eligible CD attendants no later than the first day of the second month after the quarter has concluded.

1. Once a CD attendant has been determined eligible to accrue the paid sick leave benefit, the CD attendant's eligibility shall remain in effect for the duration of the CD attendant's employment.

2. Eligible CD attendants shall accrue the paid sick leave benefit in accordance with § 40.1-33.4 of the Code of Virginia at the rate of one hour for every 30 hours worked.

3. No eligible CD attendant shall accrue more than 40 hours of paid sick leave benefit in a state fiscal year. Any amount of paid sick leave benefit carried over from the previous state fiscal year shall not count toward accrual in the current state fiscal year.

4. In accordance with § 40.1-33.4 of the Code of Virginia, any unused paid sick leave benefit shall be carried over to the state fiscal year following the state fiscal year in which it was accrued. No unused paid sick leave benefit shall be carried over for more than one state fiscal year.

5. Any CD attendant who qualified for and accrued a paid sick leave benefit in the immediately prior fiscal year shall be entitled to use the benefit in accordance with Article 2.1 (§ 40.1-33.3 et seq.) of Chapter 3 of Title 40.1 of the Code of Virginia, even if the CD attendant is not eligible for the benefit in the current state fiscal year.

6. Should a CD attendant be determined ineligible to accrue the benefit, the FEA shall reevaluate the CD attendant's eligibility upon the conclusion of the following quarter.

C. No use of this paid sick leave benefit by an eligible CD attendant shall be counted as hours worked for purposes of the following:

1. Calculation for overtime pay;

2. Accrual of additional paid sick leave benefit hours; or

3. Determination of future eligibility for this paid sick leave benefit.

D. Allowable uses of this paid sick leave benefit by a CD attendant shall be in accordance with § 40.1-33.5 of the Code of Virginia.

1. The CD attendant shall not be required to identify a replacement for any hours in which the CD attendant uses this paid sick leave benefit. When a CD attendant uses the paid sick leave benefit, it shall be the responsibility of the EOR to utilize the documented backup plan for the individual who receives CD services.

2. The EOR shall not require the CD attendant to make up any hours missed providing CD services for hours that the CD attendant used paid sick leave.

E. Pursuant to § 40.1-33.6 of the Code of Virginia, the EOR shall not engage in any retaliatory action because of an eligible CD attendant's request or use of the paid sick leave benefit or because of an allegation that the EOR has violated a provision of Article 2.1 (§ 40.1-33.3 et seq.) of Chapter 3 of Title 40.1 of the Code of Virginia.

F. No sick leave balances accrued during employment shall be paid out to the attendant at termination.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 14, eff. April 10, 2025.

Part XX Addiction and Recovery Treatment Services

12VAC30-130-5000 Addiction and recovery treatment services

The services provided for in this part shall be known as either addiction and recovery treatment services or substance use disorder services.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 33, Issue 12, eff. April 1, 2017.

12VAC30-130-5010 Addiction and recovery treatment services; purpose

The purpose of this part shall be to establish coverage of treatment for substance use disorders as defined in the American Society of Addiction Medicine (ASAM) Criteria: Treatment Criteria for Addictive, Substance-Related and Co-Occurring Conditions, Third Edition, as published by the American Society of Addiction Medicine including outpatient physician, nurse practitioner, and clinic services that include evidence-based medication assisted treatment, intensive outpatient services, partial hospitalization services, residential treatment services, and inpatient withdrawal management services as defined in 12VAC30-130-5040 through 12VAC30-130-5150.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 33, Issue 12, eff. April 1, 2017; amended, Virginia Register Volume 36, Issue 11, eff. March 5, 2020.

12VAC30-130-5020 Definitions

The following words and terms when used in this part shall have the following meanings unless the context clearly indicates otherwise:

"Abstinence" means the intentional and consistent restraint from the pathological pursuit of reward or relief, or both, that involves the use of substances.

"Addiction" means a primary, chronic disease of brain reward, motivation, memory, and related circuitry. Addiction is defined as the inability to consistently abstain, impairment in behavioral control, persistence of cravings, diminished recognition of significant problems with one's behaviors and interpersonal relationships, and a dysfunctional emotional response. Like other chronic diseases, addiction often involves cycles of relapse and remission. Without treatment or engagement in recovery activities, addiction is progressive and can result in disability or premature death.

"Addiction-credentialed physician" means a physician who holds a board certification in addiction medicine from the American Board of Addiction Medicine, a subspecialty board certification in addition to certification in psychiatry from the American Board of Psychiatry and Neurology, or subspecialty board certification in addiction medicine from the American Osteopathic Association. DMAS also recognizes physicians treating addiction who have specialty training or experience in addiction medicine or addiction psychiatry. If treating adolescents, "addiction-credentialed physician" means an addiction-credentialed physician who also has experience and specialty training with adolescent medicine.

"Adherence" means the individual receiving treatment has demonstrated ability to cooperate with, follow, and take personal responsibility for the implementation of treatment plans.

"Adolescent" means an individual from 12 years of age to 20 years of age.

"Allied health professional" means counselor aides or group living workers who meet the DBHDS licensing requirements for unlicensed staff in residential settings.

"ARTS" means addiction and recovery treatment services.

"ARTS care coordinator" means an employee of DMAS, its contractor, or an MCO who is a licensed practitioner of the healing arts, including a physician or medical director, licensed clinical psychologist, licensed clinical social worker, licensed professional counselor, licensed substance abuse treatment practitioner, licensed marriage and family therapist, nurse practitioner, or registered nurse with two years of clinical experience in the treatment of substance use disorders. The ARTS care coordinator performs independent assessments of requests for all ARTS intensive outpatient programs (ASAM Level 2.1); partial hospitalization programs (ASAM Level 2.5); residential treatment services (ASAM Levels 3.1, 3.3, 3.5, and 3.7); and inpatient services (ASAM Levels 3.7 and 4.0).

"ASAM" means the American Society of Addiction Medicine.

"ASAM criteria" means the six different life areas used by the ASAM Patient Placement Criteria to develop a holistic biopsychosocial assessment of an individual that is used for service planning, level of care, and length of stay treatment decisions.

"BHA" means behavioral health authority.

"Biomedical" means biological or physical aspects of a member's condition that require assessment and services that are delivered by appropriately credentialed medical staff, who are available to assess and treat co-occurring biomedical disorders that may be the result of, or independent of, a substance use disorder.

"Care coordination" means collaboration and sharing of information among health care providers who are involved with an individual's health care to assist in improving the care of the individual. This includes e-consultations from primary care providers to specialists.

"Certified substance abuse counselor" or "CSAC" means the same as that term is defined in § 54.1-3507.1 of the Code of Virginia.

"Certified substance abuse counseling assistant" or "CSAC-A" means the same as that term is defined in § 54.1-3507.2 of the Code of Virginia.

"Certified substance abuse counselor-supervisee" means an individual who has completed the educational requirements described in clause (i) of § 54.1-3507.1 C of the Code of Virginia, but who has not completed the practice hours described in clause (ii) of § 54.1-3507.1 C of the Code of Virginia.

"Child" means an individual from birth to 12 years of age.

"Clinical experience" means, for the purpose of these ARTS requirements, practical experience in providing direct services to individuals with diagnoses of substance use disorder. Clinical experience shall include supervised internships, supervised practicums, or supervised field experience. Clinical experience shall not include unsupervised internships, unsupervised practicums, and unsupervised field experience.

"Counseling" means the same as that term is defined in § 54.1-3500 of the Code of Virginia.

"Credentialed addiction treatment professional" or "CATP" means an individual licensed or registered with the appropriate board in the following roles: (i) an addiction-credentialed physician or physician with experience or training in addiction medicine; (ii) physician extenders with experience or training in addiction medicine; (iii) a licensed psychiatrist; (iv) a licensed clinical psychologist; (v) a licensed clinical social worker; (vi) a licensed professional counselor; (vii) a certified psychiatric clinical nurse specialist; (viii) a licensed psychiatric nurse practitioner; (ix) a licensed marriage and family therapist; (x) a licensed substance abuse treatment practitioner; (xi) a resident who is under the supervision of a licensed professional counselor (18VAC115-20-10), licensed marriage and family therapist (18VAC115-50-10), or licensed substance abuse treatment practitioner (18VAC115-60-10) and is registered with the Virginia Board of Counseling; (xii) a resident in psychology who is under supervision of a licensed clinical psychologist and is registered with the Virginia Board of Psychology (18VAC125-20-10); or (xiii) a supervisee in social work who is under the supervision of a licensed clinical social worker and is registered with the Virginia Board of Social Work (18VAC140-20-10).

"CSB" means community services board.

"DBHDS" means the Department of Behavioral Health and Developmental Services consistent with Chapter 3 (§ 37.2-300 et seq.) of Title 37.2 of the Code of Virginia.

"DEA" means Drug Enforcement Administration.

"DMAS" means the Department of Medical Assistance Services and its contractors consistent with Chapter 10 (§ 32.1-323 et seq.) of Title 32.1 of the Code of Virginia.

"DSM-5" means the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, copyright 2013, American Psychiatric Association.

"Evidence-based" means an empirically supported clinical practice or intervention with a proven ability to produce positive outcomes.

"Face-to-face" means encounters that occur in person or through telemedicine.

"FQHC" means federally qualified health center.

"Individual" means the patient, client, beneficiary, or member who receives services set out in 12VAC30-130-5000 et seq. These terms are used interchangeably.

"Individual service plan" or "ISP" means an initial and comprehensive treatment plan that is regularly updated and specific to an individual's unique treatment needs as identified in the assessment. An ISP contains an individual's treatment or training needs, the individual's goals and measurable objectives to meet the identified needs, services to be provided with the recommended frequency to accomplish the measurable goals and objectives, and an individualized discharge plan that describes transition to other appropriate services. An individual is included in the development of the ISP, and the ISP is signed by the individual. If the individual is a minor, the ISP is also signed by the individual's parent or legal guardian. An ISP includes documentation if the individual is a minor child or an adult who lacks legal capacity and is unable or unwilling to sign the ISP.

"Induction phase" means the medically monitored initiation of buprenorphine, buprenorphine and naloxone, naltrexone, or methadone treatment performed in a qualified practitioner's office or licensed OTP. The goal of the induction phase is to find the individual's ideal dose of buprenorphine, buprenorphine and naloxone, naltrexone, or methadone. The ideal dose minimizes both side effects and drug craving.

"Licensed practical nurse" means a professional who is licensed by the Commonwealth as a practical nurse or holds a multistate licensure privilege to practice practical nursing according to 18VAC90-19-80.

"Managed care organization" or "MCO" meansan organization that offers managed care health insurance plans (MCHIP), as defined by § 38.2-5800 of the Code of Virginia, which means an arrangement for the delivery of health care in which a health carrier undertakes to provide, arrange for, pay for, or reimburse any of the costs of health care services for a covered person on a prepaid or insured basis that (i) contains one or more incentive arrangements, including any credentialing requirements intended to influence the cost or level of health care services between the health carrier and one or more providers with respect to the delivery of health care services and (ii) requires or creates benefit payment differential incentives for covered persons to use providers that are directly or indirectly managed, owned, under contract with, or employed by the health carrier.

"Medication assisted treatment" or "MAT" means the same as that term is defined in 42 CFR 8.2.

"Multidimensional assessment" or "assessment" means the individualized, person-centered biopsychosocial assessment performed face-to-face, in which the provider obtains comprehensive information from the individual, and family members and significant others as needed, including history of the present illness; family history; developmental history; alcohol, tobacco, and other drug use or addictive behavior history; personal or social history; legal history; psychiatric history; medical history; spiritual history as appropriate; review of systems; mental status exam; physical examination; formulation and diagnoses; survey of assets, vulnerabilities, and supports; and treatment recommendations. The ASAM multidimensional assessment is a theoretical framework for this individualized, person-centered assessment that includes the following dimensions: (i) acute intoxication or likelihood of withdrawal, or both; (ii) medical conditions and complications, both historical and current; (iii) emotional, behavioral, or cognitive status and any identified issues; (iv) an individual's readiness to change; (v) risks for relapse or continued use; and (vi) home environment. The level of care determination, ISP, and recovery strategies development may be based upon this multidimensional assessment.

"Opioid" means any psychoactive chemical that resembles morphine in pharmacological effects, including opiates and synthetic or semisynthetic agents that exert their effects by binding to highly selective receptors in the brain where morphine and endogenous opioids affect their actions.

"Opioid treatment program" or "OTP" means the same as that term is defined in 42 CFR 8.2.

"Opioid treatment services" or "OTS" means preferred office-based opioid treatment (OBOT) and OTPs that encompass a variety of pharmacological and nonpharmacological treatment modalities, including substance use disorder counseling and psychotherapy.

"Overdose" means the inadvertent or deliberate consumption of a dose of a chemical substance much larger than either habitually used by the individual or ordinarily used for treatment of an illness that is likely to result in a serious toxic reaction or death.

"Physician extenders" means licensed nurse practitioners as defined in § 54.1-3000 of the Code of Virginia and licensed physician assistants as defined in § 54.1-2900 of the Code of Virginia.

"Preferred office-based opioid treatment" or "preferred OBOT" means addiction treatment services for individuals with a primary opioid use disorder provided by physicians and physician extenders who have a current DEA registration authorizing the prescribing of scheduled drugs, including Schedule III drugs, working in collaboration with CATPs providing psychotherapy and substance use disorder counseling in public and private practice settings.

"Program of assertive community treatment" or "PACT" means the same as that term is defined in 12VAC35-105-20.

"Psychoeducation" means (i) a specific form of education aimed at helping individuals who have a substance use disorder or mental illness and their family members or caregivers to access clear and concise information about substance use disorders or mental illness and (ii) a way of accessing and learning strategies to deal with substance use disorders or mental illness and its effects in order to design effective treatment plans and strategies.

"Psychotherapy" or "therapy" means the use of psychological methods in a professional relationship to assist a person to acquire great human effectiveness or to modify feelings, conditions, attitudes, and behaviors that are emotionally, intellectually, or socially ineffectual or maladaptive.

"Recovery" means a process of sustained effort that addresses the biological, psychological, social, and spiritual disturbances inherent in addiction and consistently pursues abstinence, behavior control, dealing with cravings, recognizing problems in one's behaviors and interpersonal relationships, and more effective coping with emotional responses leading to reversal of negative, self-defeating internal processes and behaviors and allowing healing of relationships with self and others. The concepts of humility, acceptance, and surrender are useful in this process.

"Registered nurse" or "RN" means the same as "professional nurse" is defined in § 54.1-3000 of the Code of Virginia.

"Relapse" means a process in which an individual who has established abstinence or sobriety experiences recurrence of signs and symptoms of active addiction, often including resumption of the pathological pursuit of reward or relief through the use of substances and other behaviors often leading to disengagement from recovery activities. Relapse can be triggered by exposure to (i) rewarding substances and behaviors, (ii) environmental cues to use, and (iii) emotional stressors that trigger heightened activity in brain stress circuits. The event of using or acting out is the latter part of the process, which can be prevented by early intervention.

"RHC" means rural health clinic.

"SBIRT" means screening, brief intervention, and referral to treatment. SBIRT services are an evidence-based and community-based practice designed to identify, reduce, and prevent problematic substance use disorders.

"Service authorization" means the process to approve specific services for an enrolled Medicaid, FAMIS Plus, or FAMIS individual by DMAS or its contractor, or an MCO prior to service delivery and reimbursement in order to validate that the service requested is medically necessary and meets DMAS and DMAS contractor criteria for reimbursement. Service authorization does not guarantee payment for the service.

"Substance use care coordinator" means staff in an OTP or preferred OBOT setting who have:

1. At least a bachelor's degree in one of the following fields: social work, psychology, psychiatric rehabilitation, sociology, counseling, vocational rehabilitation, or human services counseling, and at least either (i) one year of substance use disorder related direct experience or training or a combination of experience or training in providing services to individuals with a diagnosis of substance use disorder or (ii) a minimum of one year of clinical experience or training in working with individuals with co-occurring diagnoses of substance use disorder and mental illness;

2. Licensure by the Commonwealth as a registered nurse with at least either (i) one year of direct experience or training or a combination of experience and training in providing services to individuals with a diagnosis of substance use disorder or (ii) a minimum of one year of clinical experience or training or a combination of experience and training in working with individuals with co-occurring diagnoses of substance use disorder and mental illness; or

3. Certification as a CSAC or a CSAC-A.

"Substance use case management" means the same as set out in 12VAC30-50-491.

"Substance use disorder" or "SUD" means a substance-related addictive disorder, as defined in the DSM-5 with the exception of tobacco-related disorders and non-substance-related disorders, marked by a cluster of cognitive, behavioral, and physiological symptoms indicating that the individual continues to use, is seeking treatment for the use of, or is in active recovery from the use of alcohol or other drugs despite significant related problems.

"Substance use disorder counseling" means the same as "substance abuse counseling" is defined in 18VAC115-30-10.

"Telemedicine" means the real-time, two-way transfer of medical data and information using an interactive audio-video connection for the purposes of medical diagnosis and treatment. The member is located at the originating site, while the provider renders services from a remote location via the audio-video connection. Equipment utilized for telemedicine shall be of sufficient audio quality and visual clarity as to be functionally equivalent to a face-to-face encounter for professional medical services.

"Tolerance" or "tolerate" means a state of adaptation in which exposure to a drug induces changes that result in diminution of one or more of the drug's effects over time.

"Withdrawal management" means services to assist an individual's withdrawal from the use of substances.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 33, Issue 12, eff. April 1, 2017; amended, Virginia Register Volume 36, Issue 11, eff. March 5, 2020; Volume 41, Issue 3, eff. October 23, 2024.

12VAC30-130-5030 Eligible individuals

Children and adults who participate in Medicaid managed care plans and Medicaid fee for service and meet ASAM medical necessity criteria shall be eligible for ARTS.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 33, Issue 12, eff. April 1, 2017; amended, Virginia Register Volume 34, Issue 10, eff. February 7, 2018; Volume 36, Issue 11, eff. March 5, 2020.

12VAC30-130-5040 Covered services: requirements; limits; standards

A. Addiction and recovery treatment services.

1. In order to be covered, ARTS shall (i) meet medical necessity criteria based upon the multidimensional assessment completed by a CATP or a CSAC under the supervision of a CATP and (ii) be accurately reflected in provider medical record documentation and on provider claims for services by recognized diagnosis codes that support and are consistent with the requested professional services. ARTS services require a primary substance use diagnosis, and the purpose for treatment shall be related to the substance use disorder. Individuals may have a secondary, co-occurring diagnosis. A CATP or a CSAC under the supervision of a CATP shall complete the multidimensional assessments. A CATP must sign and date assessments performed by a CSAC within one business day.

2. These ARTS services, with their service definitions, shall be covered in all levels of care: (i) medically managed intensive inpatient services (ASAM Level 4); (ii) substance use residential or inpatient services (ASAM Levels 3.1, 3.3, 3.5, and 3.7); (iii) substance use intensive outpatient and partial hospitalization programs (ASAM Levels 2.1 and 2.5); (iv) opioid treatment services (opioid treatment programs and preferred office-based opioid treatment); (v) substance use outpatient services (ASAM Level 1.0); (vi) early intervention services (ASAM Level 0.5); (vii) substance use care coordination; (viii) substance use case management services; and (ix) withdrawal management services, which shall be provided when medically necessary.

B. ARTS services shall be fully integrated with all physical health and behavioral health services for a complete continuum of care for all Medicaid individuals meeting the medical necessity criteria. In order to receive reimbursement for ARTS services, the individual shall be enrolled in Virginia Medicaid and shall meet the following medical necessity criteria:

1. The individual shall demonstrate at least one diagnosis from the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) for substance-related and addictive disorders, with the exception of tobacco-related disorders and non-substance-related addictive disorders, marked by a cluster of cognitive, behavioral, and physiological symptoms indicating that the individual continues to use, is seeking treatment for the use of, or is in active recovery from the use of alcohol or other drugs despite significant related problems. Individuals younger than 21 years of age may also qualify if they are assessed to be at risk for developing a substance use disorder.

2. The individual shall be assessed by a CATP or a CSAC under the supervision of a CATP who will determine if the individual meets the severity and intensity of treatment requirements for each service level defined by the most current version of the American Society of Addiction Medicine (ASAM) Treatment Criteria for Addictive, Substance-Related and Co-Occurring Conditions (Third Edition, 2013). Medical necessity for ASAM levels of care shall be based on the outcome of the individual's documented multidimensional assessment.

3. For individuals younger than 21 years of age who do not meet the ASAM medical necessity criteria upon initial review, a second individualized review shall be conducted to determine if the individual needs medically necessary treatment under the early periodic screening diagnosis and treatment (EPSDT) benefit described in § 1905(a) of the Social Security Act to correct or ameliorate defects and physical and mental illnesses and conditions discovered by the screening.

C. Determination of medical necessity based on ASAM criteria for addiction and recovery treatment services.

1. DMAS or its contractor shall employ or contract with licensed treatment professionals to apply the ASAM criteria to review and coordinate service needs when administering ARTS benefits.

2. The ARTS care coordinator or a licensed physician or medical director employed by DMAS or its contractor or an MCO shall perform an independent assessment of requests for all ARTS intensive outpatient services (ASAM Level 2.1), partial hospitalization services (ASAM Level 2.5), residential treatment services (ASAM Levels 3.1, 3.3, 3.5, and 3.7), and ARTS inpatient treatment services (ASAM Levels 3.7 and 4.0).

3. Length of treatment and service limits shall be determined by the ARTS care coordinator or a licensed physician or medical director employed by DMAS or its contractor or an MCO who is applying the ASAM criteria.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 33, Issue 12, eff. April 1, 2017; amended, Virginia Register Volume 36, Issue 11, eff. March 5, 2020.

12VAC30-130-5050 Covered services: clinic services - opioid treatment program services

A. Settings for opioid treatment program (OTP) services. The agency-based OTP provider shall be licensed by DBHDS and contracted by DMAS or its contractor or an MCO. The staffing requirements for OTP providers shall follow the DBHDS licensing requirements set forth in 12VAC35-105-925 and in the DBHDS guidance document entitled "Opioid Medication Assisted Treatment License and Oversight" (March 2017). The interdisciplinary team shall include CATPs acting within the scope of practice in accordance to their professional regulatory board and state and federal requirements, including an addiction-credentialed physician as defined in 12VAC30-130-5020. OTP services are allowed simultaneously for members in other ASAM Levels, including 1.0 through 3.7 (excluding inpatient services). OTPs shall meet the service components, staff requirements, and risk management requirements.

B. OTP service components.

1. Linking the individual to psychological, medical, and psychiatric consultation as necessary to meet the individual's needs.

2. Access to emergency medical and psychiatric care through connections with more intensive levels of care.

3. Access to evaluation and ongoing primary care.

4. Ability to conduct or arrange for appropriate laboratory and toxicology tests including drug screenings, using either urine or blood serums.

5. Physicians who are available to evaluate and monitor (i) use of methadone, buprenorphine products, or naltrexone products and (ii) pharmacists and nurses to dispense and administer these medications and who follow the Board of Medicine guidance for treatment of individuals with buprenorphine for addiction.

6. Individualized, patient-centered assessment and treatment.

7. Ability to assess, order, administer, reassess, and regulate medication and dose levels appropriate to the individual; supervise withdrawal management from opioid analgesics, including methadone, buprenorphine products, or naltrexone products; and oversee and facilitate access to appropriate treatment for opioid use disorder.

8. Medication for other physical and mental health illness is provided as needed either on site or through collaboration with other providers.

9. Cognitive, behavioral, and other substance use disorder-focused psychotherapies and substance use disorder counseling by a CATP reflecting a variety of treatment approaches, provided to the individual on an individual, group, or family basis. CSACs and CSAC-supervisees are recognized to provide substance use disorder counseling in these settings as allowed within scopes of practice as defined in § 54.1-3507.1 of the Code of Virginia.

10. Optional substance use care coordination that includes integrating behavioral health into primary care and specialty medical settings through interdisciplinary care planning and monitoring individual progress and tracking individual outcomes; supporting conversations between physicians and physician extenders who have a current DEA registration authorizing the prescribing of scheduled drugs, including Schedule III drugs, and behavioral health professionals to develop and monitor individualized treatment plans; linking individuals with community resources to facilitate referrals and respond to social service needs; and tracking and supporting individuals when they obtain medical, behavioral health, or social services outside the practice.

11. Provision of onsite screening or the ability to refer for screening for infectious diseases such as human immunodeficiency virus, hepatitis B and C, and tuberculosis at treatment initiation and then at least annually or more often based on risk factors and the ability to provide or refer for treatment of infectious diseases as necessary.

12. Onsite medication administration treatment during the induction phase, which must be provided by a physician, nurse practitioner, physician assistant, or registered nurse. Medication administration during the maintenance phase may be provided either by a registered nurse or licensed practical nurse.

13. Prescription of naloxone for each member receiving methadone, buprenorphine products, or naltrexone products.

14. Ability to provide pregnancy testing for women of childbearing age.

15. For individuals of childbearing age, the ability to provide family planning services or to refer the individual for family planning services.

C. OTP staff requirements.

1. Staff requirements shall meet the licensing requirements of 12VAC35-105-925. The interdisciplinary team shall include CATPs trained in the treatment of opioid use disorder, including an addiction credentialed physician or physician extender and CATPs as defined in 12VAC30-130-5020. OTPs may utilize CSACs and CSAC-supervisees to provide substance use disorder counseling and psychoeducational services within their scopes of practice as defined in § 54.1-3507.1 of the Code of Virginia. OTPs may also utilize CSAC-As pursuant to § 54.1-3507.2 of the Code of Virginia as well as registered peer recovery specialists within their scopes of practice. A registered peer recovery specialist shall meet the definition in § 54.1-3500 of the Code of Virginia.

2. Staff shall be knowledgeable in the assessment, interpretation, and treatment of the biopsychosocial dimensions of alcohol or other substance use disorders.

3. A physician or physician extender as defined in 12VAC30-130-5020 shall be available during medication dispensing and clinical operating hours in person or by telephone.

D. OTP risk management shall be clearly and adequately documented in each individual's record and shall include:

1. Random drug screening, using either urine or blood serums, for all individuals, conducted at least eight times during a 12-month period as described in 12VAC35-105-980. Definitive screenings shall only be utilized when clinically indicated. Outcomes of the drug screening shall be used to support positive patient outcomes and recovery.

2. A check of the Virginia Prescription Monitoring Program prior to initiation of buprenorphine products or naltrexone products and at least quarterly for all individuals.

3. Prescription of naloxone.

4. Opioid overdose prevention education, including the purpose of and the administration of naloxone and the impact of polysubstance use. Education shall include discussion of the role of medication assisted treatment and the opportunity to reduce harm associated with polysubstance use. The goal is to help individuals remain in treatment to reduce the risk for harm.

5. Clinically indicated infectious disease testing for diseases such as HIV; hepatitis A, B, and C; syphilis; and tuberculosis at treatment initiation and then annually or more frequently, depending on the clinical scenario and the patient's risk. Those who test positive shall be treated either on site or through referral.

6. For individuals without immunity to the hepatitis B virus, vaccination, either on site or through referral, shall be offered.

7. For individuals without HIV infection, pre-exposure prophylaxis to prevent HIV infection, either on site or through referral, shall be offered.

8. Pregnancy testing for women of childbearing age, and contraceptive services, either on site or through referral, shall be offered.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 33, Issue 12, eff. April 1, 2017; amended, Virginia Register Volume 36, Issue 11, eff. March 5, 2020; Volume 41, Issue 3, eff. October 23, 2024.

12VAC30-130-5060 Covered services: clinic services - preferred office-based addiction treatment

A. Preferred office-based addiction treatment (OBAT) shall be provided by a physician or physician extender who has a current DEA registration authorizing the prescribing of scheduled drugs, including Schedule III drugs, and may be provided in a variety of practice settings, including primary care clinics, outpatient health system clinics, psychiatry clinics, FQHCs, CSBs, BHAs, local health department clinics, and physician offices. The practitioner shall be contracted by DMAS or its contractor or an MCO to perform OBAT services. OBAT services shall meet the criteria established in this section.

B. OBAT service components.

1. Access to emergency medical and psychiatric care.

2. Affiliations with more intensive levels of care such as intensive outpatient programs and partial hospitalization programs to which individuals can be referred when clinically indicated.

3. Individualized, patient-centered multidimensional assessment and treatment.

4. Assessing, ordering, administering, reassessing, and regulating medication and dose levels appropriate to the individual; supervising withdrawal management from opioid analgesics and other substances; and overseeing and facilitating access to appropriate treatment for substance use disorder.

5. Medication for other physical and mental health disorders shall be provided as needed either on site or through collaboration with other providers.

6. Assurance that medications for opioid use disorder and alcohol use disorder are only dispensed on site during the induction phase. After the induction phase, medications shall be prescribed to the member.

7. Assurance that buprenorphine monoproduct is only prescribed in accordance with Board of Medicine rules related to the prescribing of buprenorphine for addiction.

8. Cognitive, behavioral, and other substance use disorder-focused counseling and psychotherapies, reflecting a variety of treatment approaches, shall be provided to the individual on an individual, group, or family basis and shall be provided by CATPs working in collaboration with a physician or physician extender who has a current DEA registration authorizing the prescribing of scheduled drugs, including Schedule III drugs. These therapies can be provided via telemedicine as long as they meet DMAS requirements for an OBAT and for the use of telemedicine. Preferred OBATs may utilize CSACs and CSAC-supervisees to provide substance use disorder counseling and psychoeducational services within their scope of practice as defined in § 54.1-3507.1 of the Code of Virginia.

9. Substance use care coordination provided, including interdisciplinary care planning between the physicians or physician extenders who have a current DEA registration authorizing the prescribing of scheduled drugs, including Schedule III drugs, and the treatment team to develop and monitor individualized and personalized treatment plans focused on the best outcomes for the individual. This care coordination includes monitoring individual progress, tracking individual outcomes, linking the individual with community resources to facilitate referrals and respond to social service needs, and tracking and supporting the individual's medical, behavioral health, or social services received outside the practice.

10. Provision of onsite screening or referral for screening for clinically indicated infectious disease testing for diseases such as HIV; hepatitis A, B, and C; syphilis; and tuberculosis at treatment initiation and then at least annually or more often based on risk factors and the ability to provide or refer for treatment of infectious diseases as necessary.

11. Onsite medication administration treatment during the induction phase, which shall be provided by a physician, nurse practitioner, physician assistant, registered nurse, or licensed practical nurse.

12. Ability to provide pregnancy testing for women of childbearing age.

13. For individuals of childbearing age, the ability to provide family planning services or to refer the individual for family planning services.

C. OBAT staff requirements.

1. Physicians or physician extenders who have a current DEA registration authorizing the prescribing of scheduled drugs, including Schedule III drugs, are required.

2. CATPs are required and shall work in collaboration with a physician or physician extender who has a current DEA registration authorizing the prescribing of scheduled drugs, including Schedule III drugs. This collaboration can be in person or via telemedicine as long as it meets the department's requirements for the OBAT setting and for telemedicine. CSACs, CSAC-supervisees, and CSAC-As are also recognized in the preferred OBAT setting as well as registered peer recovery specialists. A registered peer recovery specialist shall meet the definition in § 54.1-3500 of the Code of Virginia.

D. OBAT risk management shall be documented in each individual's record and shall include:

1. Random drug screening, using either urine or blood serums, for all individuals, conducted at a minimum of eight times per year. Drug screenings include presumptive and definitive screenings and shall be accurately interpreted. Definitive screenings shall only be utilized when clinically indicated. Outcomes of the drug screening shall be used to support positive patient outcomes and recovery.

2. A check of the Virginia Prescription Monitoring Program prior to initiation of buprenorphine products or naltrexone products and at least quarterly for all individuals thereafter.

3. Prescription of naloxone.

4. Overdose prevention education, including the purpose of and the administration of naloxone and the impact of polysubstance use. Education shall include discussion of the role of medication assisted treatment and the opportunity to reduce harm associated with polysubstance use. The goal is to help individuals remain in treatment to reduce the risk for harm.

5. Periodic monitoring of unused medication and opened medication wrapper counts when clinically indicated.

6. Clinically indicated infectious disease testing for diseases such as HIV; hepatitis A, B, and C; syphilis; and tuberculosis at treatment initiation and then annually or more frequently, depending on the clinical scenario and the patient's risk. Those individuals who test positive shall be treated either on site or through referral.

7. For individuals without immunity to the hepatitis B virus, vaccination either on site or through referral.

8. For patients without HIV infection, pre-exposure prophylaxis to prevent HIV infection shall be offered either on site or through referral.

9. Women of child-bearing age shall be tested for pregnancy and shall be offered contraceptive services either on site or through referral.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 33, Issue 12, eff. April 1, 2017; amended, Virginia Register Volume 36, Issue 11, eff. March 5, 2020; Volume 39, Issue 5, eff. December 8, 2022; Volume 41, Issue 3, eff. October 23, 2024.

12VAC30-130-5070 Covered services: practitioner services - early intervention/screening brief intervention and referral to treatment (ASAM Level 0.5)

A. Early intervention (ASAM Level 0.5) settings for screening, brief intervention, and referral to treatment (SBIRT) services shall include health care settings, including local health departments, FQHCs, RHCs, CSBs, BHAs, health systems, emergency departments, pharmacies, physician offices, and outpatient clinics. Providers shall be licensed by the Department of Health Professions and either directly contracted by DMAS or its contractor or an MCO to perform the interpretation and intervention for this level of care or shall be employed by organizations that are contracted by DMAS or its contractor or an MCO.

B. Early intervention or SBIRT (ASAM Level 0.5) service components shall include:

1. Identifying individuals who may have alcohol or other substance use problems using an evidence-based screening tool.

2. Following administration of the evidence-based screening tool, a brief intervention by a CATP acting within the scope of the CATP's practice shall be provided to educate individuals about substance use, alert these individuals to possible consequences, and if needed, begin to motivate individuals to take steps to change their behaviors. Billing shall occur through the licensed provider or agency.

C. Early intervention or SBIRT (ASAM Level 0.5) staff requirements. Physicians, pharmacists, and other CATPs shall administer the evidence-based screening tool with the individual and provide the counseling and intervention. Licensed providers may delegate administration of the evidence-based screening tool to other clinical staff as allowed by their scope of practice, such as a CSAC, a CSAC-supervisee, a licensed registered nurse, or a licensed practical nurse. The physician may delegate the counseling and intervention but shall be available for review as needed. Billing for SBIRT shall occur through the licensed provider or agency.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 33, Issue 12, eff. April 1, 2017; amended, Virginia Register Volume 36, Issue 11, eff. March 5, 2020.

12VAC30-130-5080 Covered services: outpatient services - physician services (ASAM Level 1.0)

A. Outpatient services (ASAM Level 1.0) shall be provided by a CATP contracted by DMAS or its contractor or an MCO to perform the services in the following community based settings: primary care clinics, outpatient health system clinics, psychiatry clinics, FQHCs, RHCs, CSBs, BHAs, local health departments, and physician and provider offices. Reimbursement for substance use outpatient services shall be made for medically necessary services provided in accordance with an ISP or the treatment plan and include withdrawal management as necessary. Services can be provided in person or by telemedicine. Outpatient services shall meet the ASAM Level 1.0 service components and staff requirements as follows:

1. Outpatient services (ASAM Level 1.0) service components.

a. Substance use outpatient services shall be provided fewer than nine hours per week and may be delivered in the following health care settings: local health departments, FQHCs, rural health clinics, CSBs, BHAs, health systems, emergency departments, physician and provider offices, and outpatient clinics. Provision of services in a setting other than the office or a clinic, as defined in this subsection shall be documented. Services shall include professionally directed screening, evaluation, treatment, and ongoing recovery and disease management services.

b. A multidimensional assessment shall (i) be used, (ii) be documented to determine that an individual meets the medical necessity criteria, and (iii) include the evaluation or analysis of substance use disorders, the diagnosis of substance use disorder, and the assessment of treatment needs to provide medically necessary services. The multidimensional assessment shall include a physical examination and laboratory testing necessary for substance use disorder treatment as necessary.

c. Individual psychotherapy or substance use disorder counseling shall be provided by a CATP. Services shall be provided in person or by telemedicine.

d. Group psychotherapy or substance use disorder counseling shall be provided by a CATP with a maximum of 10 individuals in the group and shall focus on the needs of the individuals served.

e. Family psychotherapy or substance use disorder counseling shall be provided by a CATP to facilitate the individual's recovery and support for the family's recovery.

f. Evidenced-based patient education on addiction, treatment, recovery, and associated health risks shall be provided.

g. Medication services shall be provided, including the prescription of or administration of medication related to substance use treatment or the assessment of the side effects or results of that medication. Medication services shall be provided by staff lawfully authorized to provide such services who shall order laboratory testing within their scope of practice or licensure.

h. Collateral services shall be provided.

2. Outpatient services (ASAM Level 1.0) staff requirements shall include:

a. A CATP; or

b. A registered nurse or a practical nurse who is licensed by the Commonwealth with at least one year of clinical experience involving medication management.

B. Outpatient services (ASAM Level 1.0) co-occurring enhanced programs shall include:

1. Ongoing substance use case management for highly crisis prone individuals with co-occurring disorders.

2. CATPs who are trained in severe and chronic mental health and psychiatric disorders and are able to assess, monitor, and manage individuals who have a co-occurring mental health disorder. "Co-occurring disorders" means the presence of concurrent substance use disorder and mental illness without implication as to which disorder is primary and which is secondary, which disorder occurred first, or whether one disorder caused the other.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 33, Issue 12, eff. April 1, 2017; amended, Virginia Register Volume 36, Issue 11, eff. March 5, 2020.

12VAC30-130-5090 Covered services: community based services - intensive outpatient services (ASAM Level 2.1)

A. Intensive outpatient services (ASAM Level 2.1) shall be a structured program of skilled treatment services for adults, children, and adolescents delivering a minimum of three service hours per service day for adults to achieve an average of nine to 19 hours of services per week and a minimum of two service hours per service day for children and adolescents to achieve an average of six to 19 hours of services per week. Withdrawal management services may be provided as necessary. The following service components shall be provided weekly as directed by the ISP for reimbursement:

1. Medical, psychological, psychiatric, laboratory, and toxicology services, which are available through consultation or referral.

2. Psychiatric and other individualized treatment planning.

3. Individual, family, and group psychotherapy, substance use disorder counseling, medication management, and psychoeducation.

4. Medication assisted treatment that is provided on site or through referral.

5. Occupational and recreational therapies, motivational interviewing, enhancement, and engagement strategies to inspire an individual's motivation to change behaviors.

6. Psychiatric and medical consultation, which shall be available within 24 hours of the requested consult by telephone and preferably within 72 hours of the requested consult in person or via telemedicine.

7. Psychopharmacological consultation.

8. Addiction medication management and 24-hour crisis services.

9. Medical, psychological, psychiatric, laboratory, and toxicology services.

B. Intensive outpatient services (ASAM Level 2.1) shall be provided by agency-based providers that shall be licensed by DBHDS as a substance abuse intensive outpatient service for adults, children, and adolescents and contracted with DMAS or its contractor or an MCO to provide this service. Intensive outpatient service providers shall meet the ASAM Level 2.1 service components and staff requirements as follows:

1. Interdisciplinary team of CATPs shall be required. ASAM Level 2.1 may utilize CSACs or CSAC-supervisees to provide substance use disorder counseling and psychoeducational services within their scopes of practice as defined in § 54.1-3507.1 of the Code of Virginia.

2. Generalist physicians or physicians with experience in addiction medicine are permitted to provide general medical evaluations and concurrent or integrated general medical care.

3. Physicians and physician extenders who have a current DEA registration authorizing the prescribing of scheduled drugs, including Schedule III drugs, who are either employed by or contracted with the agency or through referral arrangements with the agency.

4. Staff who shall be cross-trained to understand signs and symptoms of psychiatric disorders and be able to understand and explain the uses of psychotropic medications and understand interactions with substance use and other addictive disorders.

5. Emergency services, which shall be available, when necessary, by telephone 24 hours per day and seven days per week when the treatment program is not in session.

6. Direct affiliation with, or close coordination through referrals to, higher and lower levels of care and supportive housing services.

C. Intensive outpatient services (ASAM Level 2.1) co-occurring enhanced programs.

1. Co-occurring capable programs offer these therapies and support systems in intensive outpatient services described in this section to individuals with co-occurring addictive and psychiatric disorders who are able to tolerate and benefit from a planned program of therapies.

2. Individuals who are not able to benefit from a full program of therapies will be offered enhanced program services to match the intensity of hours in ASAM Level 2.1, including substance use case management, program of assertive community treatment (PACT), medication management, and psychotherapy.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 33, Issue 12, eff. April 1, 2017; amended, Virginia Register Volume 36, Issue 11, eff. March 5, 2020; Volume 41, Issue 3, eff. October 23, 2024.

12VAC30-130-5100 Covered services: community based care - partial hospitalization services (ASAM Level 2.5)

A. Partial hospitalization services (ASAM Level 2.5) components. Partial hospitalization services components shall include the following, as defined in the ISP and provided on a weekly basis:

1. Individualized treatment planning.

2. A minimum of 20 hours per week and at least five service hours per service day of skilled treatment services with a planned format, including individual and group psychotherapy, substance use disorder counseling, medication management, education groups, occupational and recreational therapy, and other therapies. Withdrawal management services may be provided as necessary. Time not spent in skilled, clinically intensive treatment is not billable.

3. Family psychotherapy and substance use disorder counseling involving family members, guardians, or significant others in the assessment, treatment, and continuing care of the individual.

4. Motivational interviewing, enhancement, and engagement strategies.

5. Medication assisted treatment that is provided on site or through referral.

B. Partial hospitalization services (ASAM Level 2.5). The substance use partial hospitalization service provider shall be licensed by DBHDS as a substance abuse partial hospitalization program or substance abuse or mental health partial hospitalization program and contracted with DMAS or its contractor or an MCO. Partial hospitalization service providers shall meet the ASAM Level 2.5 support systems and staff requirements as follows:

1. Interdisciplinary team comprised of CATPs, which shall include an addiction-credentialed physician or physician with experience in addiction medicine, or physician extenders as defined in 12VAC30-130-5020. ASAM Level 2.5 may utilize CSACs or CSAC-supervisees to provide substance use disorder counseling and psychoeducational services within their scopes of practice as defined in § 54.1-3507.1 of the Code of Virginia.

2. Physicians shall have specialty training or experience, or both, in addiction medicine or addiction psychiatry. Physicians who treat adolescents shall have experience with adolescent medicine.

3. Physicians and physician extenders who have a current DEA registration authorizing the prescribing of scheduled drugs, including Schedule III drugs, who are either employed by or contracted with the agency.

4. Program staff shall be cross-trained to understand signs and symptoms of mental illness and be able to understand and explain the uses of psychotropic medications and understand interactions with substance use and other addictive disorders.

5. Medical, psychological, psychiatric, laboratory, and toxicology services that are available by consult or referral.

6. Psychiatric and medical formal agreements to provide medical consult within eight hours of the requested consult by telephone or within 48 hours in person or via telemedicine.

7. Emergency services are available 24 hours a day and seven days a week.

8. Direct affiliation with or close coordination through referrals to higher and lower levels of care and supportive housing services.

C. Partial hospitalization services (ASAM Level 2.5) co-occurring enhanced programs shall offer:

1. Therapies and support systems as described in this section to individuals with co-occurring addictive and psychiatric disorders who are able to tolerate and benefit from a full program of therapies. Other individuals who are not able to benefit from a full program of therapies (who are severely or chronically mentally ill) will be offered enhanced program services to constitute intensity of hours in ASAM Level 2.5, including substance use case management, PACT, medication management, and psychotherapy.

2. Psychiatric services as appropriate to meet the individual's mental health condition. Services may be available by telephone and on site, or closely coordinated off site, or via telemedicine within a shorter time than in a co-occurring capable program.

3. Clinical leadership and oversight and, at a minimum, capacity to consult with an addiction psychiatrist via telephone, via telemedicine, or in person.

4. CATPs with experience assessing and treating co-occurring mental illness.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 33, Issue 12, eff. April 1, 2017; amended, Virginia Register Volume 36, Issue 11, eff. March 5, 2020; Volume 41, Issue 3, eff. October 23, 2024.

12VAC30-130-5110 Covered services: clinically managed low intensity residential services (ASAM Level 3.1)

A. Clinically managed low intensity residential services (ASAM Level 3.1). The agency-based residential group home services (ASAM Level 3.1) shall be licensed by DBHDS as a mental health and substance abuse group home service for adults or children or licensed by DBHDS as a supervised living residence for adults and contracted by DMAS or its contractor or an MCO. Clinically directed program activities constituting at least five hours per week of professionally directed treatment shall be designed to stabilize and maintain substance use disorder symptoms and to develop and apply recovery skills. Activities shall include relapse prevention, interpersonal choice exploration, and development of social networks in support of recovery. This service shall not include settings where clinical treatment services are not provided. ASAM Level 3.1 clinically managed low intensity residential service providers shall meet the service components and staff requirements of this section.

B. Clinically managed low intensity residential services (ASAM Level 3.1) service components.

1. Physician consultation and emergency services, which shall be available 24 hours a day and seven days per week.

2. Arrangements for medically necessary procedures including laboratory and toxicology tests that are appropriate to the severity and urgency of an individual's condition.

3. Arrangements for pharmacotherapy for psychiatric needs.

4. Medication assisted treatment that is provided onsite or through referral.

5. Arrangements for higher and lower levels of care and other services.

C. The following services shall be provided as directed by the ISP:

1. Clinically-directed treatment to facilitate recovery skills, relapse prevention, and emotional coping strategies. Services shall promote personal responsibility and reintegration of the individual into the network systems of work, education, and family life;

2. Addiction pharmacotherapy and drug screening;

3. Motivational enhancement and engagement strategies;

4. Substance use disorder counseling and clinical monitoring;

5. Regular monitoring of the individual's medication adherence;

6. Recovery support services;

7. Services for the individual's family and significant others, as appropriate to advance the individual's treatment goals and objectives identified in the ISP; and

8. Education on benefits of medication assisted treatment and referral to treatment as necessary.

D. Clinically managed low intensity residential services (ASAM Level 3.1) staff requirements.

1. Staff shall provide awake 24-hour onsite supervision. The provider's staffing plan must be in compliance with DBHDS licensing regulations for staffing plans set forth in 12VAC35-46-870 and 12VAC35-105-590.

2. Clinical staff who are experienced and knowledgeable about the biopsychosocial and psychosocial dimensions and treatment of substance use disorders. Clinical staff shall be able to identify the signs and symptoms of acute psychiatric conditions and decompensation.

3. An addiction-credentialed physician or physician with experience in addiction medicine or a physician extender acting within his scope of practice shall review the residential group home admission if the multidimensional assessment indicates medical concerns or systems in ASAM Dimension 1 or 2, to confirm medical necessity for services and a team of CATPs who shall develop and shall ensure delivery of the ISP. For ASAM Level 3.1, the ISP may be completed by a CSAC or CSAC-supervisee if the CATP signs and dates the ISP within one business day.

4. Coordination with community physicians to review treatment as needed.

5. Appropriately credentialed medical staff shall be available to assess and treat co-occurring biomedical disorders and to monitor the individual's administration of prescribed medications.

E. Clinically managed low intensity residential services (ASAM Level 3.1) co-occurring enhanced programs as required by ASAM.

1. In addition to the ASAM Level 3.1 service components listed in this section, programs for individuals with both unstable substance use and psychiatric disorders shall offer appropriate psychiatric services, including medication evaluation and laboratory services. Such services are provided either onsite, via telemedicine, or closely coordinated with an offsite provider, as appropriate to the severity and urgency of the individual's mental health condition.

2. Certified addiction treatment professionals shall be cross-trained in addiction and mental health to (i) understand the signs and symptoms of mental illness and (ii) understand and be able to explain to the individual the purpose of psychotropic medications and interactions with substance use.

3. The therapies described in this section shall be offered as well as planned clinical activities (either onsite or with an offsite provider) that are designed to stabilize and maintain the individual's mental health program and psychiatric symptoms.

4. Goals of therapy shall apply to both the substance use disorder and any co-occurring mental illness.

5. Medication education and management shall be provided.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 33, Issue 12, eff. April 1, 2017; amended, Virginia Register Volume 36, Issue 11, eff. March 5, 2020.

12VAC30-130-5120 Covered services: clinically managed population - specific high intensity residential service (ASAM Level 3.3)

A. Clinically managed population-specific high intensity residential service (ASAM Level 3.3). The facility-based provider shall be licensed by DBHDS as (i) a supervised residential treatment service for adults; (ii) a substance abuse residential treatment service for adults; (iii) a substance abuse residential treatment service for women with children; (iv) a substance abuse and mental health residential treatment service for adults that has substance abuse listed on its license or within the "licensed as" statement or be a Level C (psychiatric residential treatment facility) service provider; or (v) a "mental health residential-children" provider that has substance abuse listed on its license or within the "licensed as" statements. All providers shall be contracted by DMAS or its contractor or an MCO. ASAM Level 3.3 settings do not include sober houses, boarding houses, or group homes where treatment services are not provided. Residential treatment service providers for clinically managed population-specific high intensity residential service (ASAM Level 3.3) shall meet the service components and staff requirements in this section.

B. Clinically managed population-specific high intensity residential service (ASAM Level 3.3) service components.

1. Clinically managed population-specific high intensity residential service components shall include:

a. Access to a consulting physician or physician extender who is either employed by or contracted with the agency or through referral arrangements with the agency and who has a current DEA registration authorizing the prescribing of scheduled drugs, including Schedule III drugs, and emergency services 24 hours a day and seven days a week;

b. Arrangements for higher and lower levels of care;

c. Arrangements for laboratory and toxicology services appropriate to the severity of need; and

d. Arrangements for addiction pharmacotherapy, including medication assisted treatment that is provided on site or through referral.

2. The following therapies shall be provided as directed by the ISP for reimbursement:

a. Clinically directed treatment to facilitate recovery skills, relapse prevention, and emotional coping strategies. Services shall promote personal responsibility and reintegration of the individual into the network systems of work, education, and family life;

b. Addiction pharmacotherapy, including medication assisted treatment that is provided on site or through referral;

c. Drug screening, using either urine or blood serums;

d. A range of cognitive and behavioral psychotherapies administered individually and in family and group settings as appropriate to the individual's needs to assist the individual in initial involvement or re-engagement in regular productive daily activity;

e. Substance use disorder counseling and psychoeducation activities provided individually or in family and group settings to promote recovery;

f. Recreational therapy, art, music, physical therapy, and vocational rehabilitation;

g. Motivational enhancement and engagement strategies;

h. Regular monitoring of the individual's medication adherence;

i. Recovery support services;

j. Services for the individual's family and significant others, as appropriate to advance the individual's treatment goals and objectives identified in the ISP;

k. Education on benefits of medication assisted treatment and referral to treatment as necessary; and

l. Withdrawal management services may be provided as necessary.

C. Clinically managed population-specific high intensity residential service (ASAM Level 3.3) staff requirements.

1. The interdisciplinary team shall include CATPs and allied health professionals in an interdisciplinary team. ASAM Level 3.3 may utilize CSACs or CSAC-supervisees to provide substance use disorder counseling and psychoeducational services within their scopes of practice as defined in § 54.1-3507.1 of the Code of Virginia.

2. Staff shall provide awake 24-hour onsite supervision. The provider's staffing plan must be in compliance with DBHDS licensing regulations for staffing plans set forth in 12VAC35-46-870 and 12VAC35-105-590.

3. Clinical or credentialed staff shall be experienced and knowledgeable about the biopsychosocial dimensions and treatment of substance use disorders and who are available on site or by telephone 24 hours per day. Licensed clinical staff shall be able to identify acute psychiatric conditions and decompensation.

4. Substance use case management is included in this level of care.

5. Appropriately credentialed medical staff shall be available to assess and treat co-occurring biomedical disorders and to monitor the individual's administration of prescribed medications.

D. Clinically managed population-specific high intensity residential service co-occurring enhanced programs, as required by ASAM.

1. Appropriate psychiatric services, including medication evaluation and laboratory services, shall be provided on site or through a closely coordinated offsite provider, as appropriate to the severity and urgency of the individual's mental condition.

2. CATPs shall be available to assess and treat co-occurring substance use and mental illness using specialized training in behavior management techniques.

3. Credentialed addiction treatment professionals shall be cross-trained in addiction and mental health to understand the signs and symptoms of mental illness and be able to provide education to the individual on the interactions with substance use and psychotropic medications.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 33, Issue 12, eff. April 1, 2017; amended, Virginia Register Volume 36, Issue 11, eff. March 5, 2020; Volume 41, Issue 3, eff. October 23, 2024.

12VAC30-130-5130 Covered services: clinically managed high intensity residential services (adult) and clinically managed medium intensity residential services (adolescent) (ASAM Level 3.5)

A. Clinically managed high intensity residential services (adult) and clinically managed medium intensity residential services (adolescent) (ASAM Level 3.5) settings for services. The facility based residential treatment service provider (ASAM Level 3.5) shall be licensed as (i) a substance abuse residential treatment service for adults or children, (ii) a psychiatric unit that has substance abuse listed on its license or within the "licensed as" statements, (iii) a substance abuse residential treatment service for women with children, (iv) a substance abuse and mental health residential treatment service for adults and children that has substance abuse listed on its license or within the "licensed as" statements, (v) a Level C (psychiatric residential treatment facility) provider, or (vi) a "mental health residential-children" provider that has substance abuse on its license or within the "licensed as" statements and shall be contracted by DMAS or its contractor or an MCO. Residential treatment providers (ASAM Level 3.5) shall meet the service components and staff requirements in this section.

B. Clinically managed high intensity residential services (adult) and clinically managed medium intensity residential services (adolescent) (ASAM Level 3.5) service components.

1. These residential treatment services, as required by ASAM, include:

a. Telephone or in-person consultation with a physician or physician extender who shall be available to perform required physician services. Emergency services shall be available 24 hours per day and seven days per week;

b. Arrangements for more and less intensive levels of care and other services such as sheltered workshops, literacy training, and adult education;

c. Arrangements for needed procedures, including medical, psychiatric, psychological, laboratory, and toxicology services appropriate to the severity of need; and

d. Arrangements for addiction pharmacotherapy, including medication assisted treatment that is provided on site or through referral.

2. The following therapies shall be provided as directed by the ISP for reimbursement:

a. Clinically directed treatment to facilitate recovery skills, relapse prevention, and emotional coping strategies. Services shall promote personal responsibility and reintegration of the individual into the network systems of work, education, and family life. Activities shall be designed to stabilize and maintain substance use disorder symptoms and apply recovery skills and may include relapse prevention, interpersonal choice exploration, and development of social networks in support of recovery.

b. Range of cognitive, behavioral psychotherapies, and substance use disorder counseling administered individually and in family and group settings to assist the individual in initial involvement or re-engagement in regular productive daily activities, including education on medication management, addiction pharmacotherapy, and education skill building groups to enhance the individual's understanding of substance use and mental illness.

c. Psychoeducational activities.

d. Addiction pharmacotherapy and drug screening.

e. Recreational therapy, art, music, physical therapy, and vocational rehabilitation.

f. Motivational enhancements and engagement strategies.

g. Monitoring of the adherence to prescribed medications and over-the-counter medications and supplements.

h. Daily scheduled professional services and interdisciplinary assessments and treatment designed to develop and apply recovery skills.

i. Services for family and significant others, as appropriate, to advance the individual's treatment goals and objectives identified in the ISP.

j. Withdrawal management services may be provided as necessary.

C. Clinically managed high intensity residential services (adult) and clinically managed medium intensity residential services (adolescent) (ASAM Level 3.5) staff requirements.

1. The interdisciplinary team shall include CATPs, physicians, or physician extenders and allied health professionals. Physicians and physician extenders who have a current DEA registration authorizing the prescribing of scheduled drugs, including Schedule III drugs, and who are either employed by or contracted with the agency or through referral arrangements with the agency. ASAM Level 3.5 may utilize CSACs or CSAC-supervisees to provide substance use disorder counseling and psychoeducational services within their scopes of practice as defined in § 54.1-3507.1 of the Code of Virginia.

2. Staff shall provide awake 24-hour onsite supervision. The provider's staffing plan must be in compliance with DBHDS licensing regulations for staffing plans set forth in 12VAC35-46-870 and 12VAC35-105-590.

3. Clinical staff who are experienced in and knowledgeable about the biopsychosocial dimensions and treatment of substance use disorders. Clinical staff shall be able to identify acute psychiatric conditions and decompensations.

4. Substance use case management shall be provided in this level of care.

5. Appropriately credentialed medical staff shall be available on site or by telephone 24 hours per day, seven days per week to assess and treat co-occurring biological and physiological disorders and to monitor the individual's administration of medications in accordance with a physician's prescription.

D. Clinically managed high intensity residential services (adult) and clinically managed medium intensity residential services (adolescent) (ASAM Level 3.5) co-occurring enhanced programs as required by ASAM.

1. Psychiatric services, medication evaluation, and laboratory services shall be provided. Such services shall be available by telephone within eight hours of requested service and on site or via telemedicine, or closely coordinated with an offsite provider within 24 hours of requested service, as appropriate to the severity and urgency of the individual's mental and physical condition.

2. Staff shall be CATPs who are able to assess and treat co-occurring substance use and psychiatric disorders.

3. Planned clinical activities shall be required and shall be designed to stabilize and maintain the individual's mental health problems and psychiatric symptoms.

4. Medication education and management shall be provided.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 33, Issue 12, eff. April 1, 2017; amended, Virginia Register Volume 36, Issue 11, eff. March 5, 2020; Volume 41, Issue 3, eff. October 23, 2024.

12VAC30-130-5140 Covered services: medically monitored intensive inpatient services (adult) and medically monitored high intensity inpatient services (adolescent) (ASAM Level 3.7)

A. Medically monitored intensive inpatient services (adult) and medically monitored high intensity inpatient services (adolescent) (ASAM Level 3.7) settings for services. The facility-based provider of ASAM Level 3.7 services shall be licensed by DBHDS as (i) a freestanding psychiatric hospital or inpatient psychiatric unit with a DBHDS medical detoxification license or managed withdrawal license; (ii) a residential crisis stabilization unit with a DBHDS medical detoxification license or managed withdrawal license; (iii) a substance abuse residential treatment service for women with children with a DBHDS managed withdrawal license; (iv) a Level C (psychiatric residential treatment facility) provider; (v) a "mental health residential-children" provider with a substance abuse residential license and a DBHDS managed withdrawal license; (vi) a "managed withdrawal-medical detox adult residential treatment" provider; or (vii) a "medical detox-chemical dependency unit" for adults and shall be contracted by DMAS or its contractor or the MCO. ASAM Level 3.7 providers shall meet the service components and staff requirements in this section.

B. Medically monitored intensive inpatient services (adult) and medically monitored high intensity inpatient services (adolescent) (ASAM Level 3.7) service components. The following therapies shall be provided as directed by the ISP for reimbursement:

1. Daily clinical services provided by an interdisciplinary team to involve appropriate medical and nursing services, as well as individual, group, and family activity services. Activities may include pharmacological, including medication assisted treatment that is provided on site or through referral; withdrawal management; cognitive-behavioral; and other psychotherapies and substance use disorder counseling administered on an individual or group basis and modified to meet the individual's level of understanding and assist in the individual's recovery.

2. Counseling and clinical monitoring to facilitate re-involvement in regular productive daily activities and successful re-integration into family living if applicable.

3. Psychoeducational activities.

4. Random drug screens to monitor use and strengthen recovery and treatment gains.

5. Regular medication monitoring.

6. Planned clinical activities to enhance understanding of substance use disorders.

7. Health education associated with the course of addiction and other potential health related risk factors, including tuberculosis, human immunodeficiency virus, hepatitis B and C, and other sexually transmitted infections.

8. Evidence based practices, such as motivational interviewing to address an individual's readiness to change, designed to facilitate understanding of the relationship of the substance use disorder and life impacts.

9. Daily treatments to manage acute symptoms of biomedical substance use or mental illness.

10. Services to family and significant others as appropriate to advance the individual's treatment goals and objectives identified in the ISP.

11. Physician monitoring, nursing care, and observation shall be available. A physician shall be available to assess the individual in person or via telemedicine within 24 hours of admission and thereafter as medically necessary.

12. A licensed and registered nurse who shall conduct an alcohol or other drug-focused nursing assessment upon admission. A licensed registered nurse or licensed practical nurse shall be responsible for monitoring the individual's progress and for medication administration duties.

13. Additional medical specialty consultation; psychological, laboratory, and toxicology services shall be available on site, either through consultation or referral.

14. Coordination of necessary services shall be available on site or through referral to a closely coordinated offsite provider to transition the individual to lower levels of care.

15. Psychiatric services shall be available on site or through consultation or referral to a closely coordinated offsite provider when a presenting problem could be attended to at a later time. Such services shall be available within eight hours of requested service by telephone or within 24 hours of requested service in person or via telemedicine.

C. Medically monitored intensive inpatient services (adult) and medically monitored high intensity inpatient services (adolescent) (ASAM Level 3.7) staff requirements.

1. The interdisciplinary team shall include CATPs and addiction-credentialed physicians or physicians with experience in addiction medicine to assess, treat, and obtain and interpret information regarding the individual's psychiatric and substance use disorders. Physicians and physician extenders who have a current DEA registration authorizing the prescribing of scheduled drugs, including Schedule III drugs, and who are either employed by or contracted with the agency or through referral arrangements with the agency. ASAM Level 3.7 may utilize CSACs or CSAC-supervisees to provide substance use disorder counseling and psychoeducational services within their scopes of practice as defined in § 54.1-3507.1 of the Code of Virginia.

2. Clinical staff shall be knowledgeable about the biological and psychosocial dimensions of substance use disorders and mental illnesses and their treatment. Clinical staff shall be able to identify acute psychiatric conditions, symptom increase or escalation, and decompensation.

3. Clinical staff shall be able to provide a planned regimen of 24-hour professionally directed evaluation, care, and treatment, including the administration of prescribed medications.

4. An addiction-credentialed physician or physician with experience in addiction medicine shall oversee the treatment process and ensure quality of care. Licensed physicians shall perform physical examinations for all individuals who are admitted. Staff shall supervise addiction pharmacotherapy integrated with psychosocial therapies. The professional may be a physician or a psychiatrist, or a physician extender as defined in 12VAC30-130-5020 if knowledgeable about addiction treatment.

D. Medically monitored intensive inpatient services (adult) and medically monitored high intensity inpatient services (adolescent) (ASAM Level 3.7) co-occurring enhanced programs as required by ASAM.

1. Appropriate psychiatric services, medication evaluation, and laboratory services shall be available.

2. A psychiatrist assessment of the individual shall occur within four hours of admission by telephone and within 24 hours following admission in person or via telemedicine, or sooner, as appropriate to the individual's behavioral health condition, and thereafter as medically necessary.

3. A behavioral health-focused assessment at the time of admission shall be performed by a registered nurse or licensed mental health clinician. A licensed registered nurse or licensed practical nurse supervised by a registered nurse shall be responsible for monitoring the individual's progress and administering or monitoring the individual's self-administration of medications.

4. Psychiatrists and CATPs who are able to assess and treat co-occurring psychiatric disorders and who have specialized training in the behavior management techniques and evidenced-based practices shall be available.

5. Access to an addiction-credentialed physician shall be available along with access to either a psychiatrist, a certified addiction psychiatrist, or a psychiatrist with experience in addiction medicine.

6. CATPs shall have experience and training in addiction and mental health to understand the signs and symptoms of mental illness and be able to provide education to the individual on the interaction of substance use and psychotropic medications.

7. Planned clinical activities shall be offered and designed to promote stabilization and maintenance of the individual's behavioral health needs, recovery, and psychiatric symptoms.

8. Medication education and management shall be offered.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 33, Issue 12, eff. April 1, 2017; amended, Virginia Register Volume 36, Issue 11, eff. March 5, 2020; Volume 41, Issue 3, eff. October 23, 2024.

12VAC30-130-5150 Covered services: medically managed intensive inpatient services (ASAM Level 4.0)

A. Medically managed intensive inpatient services (ASAM Level 4.0) settings for services. Acute care hospitals licensed by the Virginia Department of Health shall be the designated setting for medically managed intensive inpatient treatment and shall offer medically directed acute withdrawal management and related treatment designed to alleviate acute emotional, behavioral, cognitive, or biomedical distress resulting from, or occurring with, an individual's use of alcohol and other drugs. Such service settings shall offer medically directed acute withdrawal management and related treatment designed to alleviate acute emotional, behavioral, cognitive, or biomedical distress, or all of these, resulting from, or co-occurring with, an individual's use of alcohol or other drugs, with the exception of tobacco-related disorders, caffeine-related disorders or dependence or non-substance-related disorders.

B. Medically managed intensive inpatient services (ASAM Level 4.0) service components.

1. The service components of medically managed intensive inpatient services shall be:

a. An evaluation or analysis of substance use disorders shall be provided, including the diagnosis of substance use disorders and the assessment of treatment needs for medically necessary services.

b. Observation and monitoring the individual's course of withdrawal shall be provided. This shall be conducted as frequently as deemed appropriate for the individual and the level of care the individual is receiving. This may include, for example, observation of the individual's health status.

c. Medication services, including the prescription or administration related to substance use disorder treatment services or the assessment of the side effects or results of that medication, conducted by appropriate licensed staff who provide such services within their scope of practice or license.

2. The following therapies shall be provided for reimbursement:

a. Daily clinical services provided by an interdisciplinary team to stabilize acute addictive or psychiatric symptoms. Activities shall include pharmacological, cognitive-behavioral, and other psychotherapies or substance use disorder counseling administered on an individual or group basis and modified to meet the individual's level of understanding. For individuals with a severe biomedical disorder, physical health interventions are available to supplement addiction treatment. For the individual who has less stable psychiatric symptoms, ASAM Level 4.0 co-occurring capable programs offer individualized treatment activities designed to monitor the individual's mental health and to address the interaction of the mental health programs and substance use disorders.

b. Health education services.

c. Planned clinical interventions that are designed to enhance the individual's understanding and acceptance of illness of addiction and the recovery process.

d. Services for the individual's family, guardian, or significant other, as appropriate, to advance the individual's treatment and recovery goals and objectives identified in the ISP.

e. This level of care offers 24-hour nursing care and daily physician care for severe, unstable problems in any of the following ASAM dimensions: (i) acute intoxication or withdrawal potential; (ii) biomedical conditions and complications; and (iii) emotional, behavioral, or cognitive conditions and complications.

f. Discharge services shall be the process to prepare the individual for referral into another level of care, post treatment return or reentry into the community, or the linkage of the individual to essential community treatment, housing, recovery, and human services.

C. Medically managed intensive inpatient services (ASAM Level 4.0) staff requirements.

1. An interdisciplinary staff of appropriately credentialed clinical staff including, for example, addiction-credentialed physicians or physicians with experience in addiction medicine, licensed nurse practitioners, licensed physician assistants, registered nurses, licensed professional counselors, licensed clinical psychologists, or licensed clinical social workers who assess and treat individuals with severe substance use disorders or addicted individuals with concomitant acute biomedical, emotional, or behavioral disorders. Physicians and physician extenders who have a current DEA registration authorizing the prescribing of scheduled drugs, including Schedule III drugs, and who are either employed by or contracted through the agency or through referral arrangements with the agency.

2. Medical management by physicians and primary nursing care shall be available 24 hours per day and counseling services shall be available 16 hours per day.

D. Medically managed intensive inpatient services (ASAM Level 4.0) co-occurring enhanced programs. These programs shall be provided by appropriately licensed or registered credentialed mental health professionals who assess and treat the individual's co-occurring mental illness and are knowledgeable about the biological and psychosocial dimensions of psychiatric disorders and his treatment.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 33, Issue 12, eff. April 1, 2017; amended, Virginia Register Volume 36, Issue 11, eff. March 5, 2020; Volume 41, Issue 3, eff. October 23, 2024.

12VAC30-130-5160 Peer support services and family support partners: definitions

The following words and terms when used in this part shall have the following meanings:

"Behavioral health service" means treatments and services for mental or substance use disorders.

"Caregiver" means the family members, friends, or neighbors who provide unpaid assistance to a Medicaid member with a mental health or substance use disorder or co-occurring mental health and substance use disorder. "Caregiver" does not include individuals who are employed to care for the member.

"Direct supervisor" means the person who provides direct supervision to the peer recovery specialist. The direct supervisor (i) shall have two consecutive years of documented practical experience rendering peer support services or family support services, have certification as a PRS under a certifying body approved by DBHDS, and have documented completion of the DBHDS PRS supervisor training; (ii) shall be a practitioner who has documented completion of the DBHDS PRS supervisor training, meets the definition of "credentialed addiction treatment professional" found in 12VAC30-130-5020, and is acting within his scope of practice under state law; or (iii) shall be a certified substance abuse counselor (CSAC) as defined in § 54.1-3507.1 of the Code of Virginia who has documented completion of the DBHDS PRS supervisor training if he is acting under the supervision or direction of a licensed substance use treatment practitioner or licensed mental health professional. If a practitioner referenced in clause (ii) of this definition or a CSAC referenced in clause (iii) of this definition provides services before April 1, 2018, he shall have until April 1, 2018, to complete the DBHDS PRS supervisor training.

"Peer recovery specialist" or "PRS" means a person who has the qualifications, education, and experience established by the Department of Behavioral Health and Developmental Services in 12VAC35-250-10.

"Peer recovery support services" means the same as defined in 12VAC35-250-10.

"Person centered" means a collaborative process where the individual participates in the development of his treatment goals and makes decisions about the services provided.

"Recovery-oriented services" means providing support and assistance to an individual with mental health or substance use disorders or both so that the individual (i) improves his health, recovery, resiliency, and wellness; (ii) lives a self-directed life; and (iii) strives to reach his full potential.

"Recovery, resiliency, and wellness plan" means a written set of goals, strategies, and actions to guide the individual and the health care team to move the individual toward the maximum achievable independence and autonomy in the community. The documented comprehensive wellness plan shall be developed with the LMHP, LMHP-R, LMHP-RP, or LMHP-S who conducted the assessment and made the recommendation, along with the individual or caregiver, as applicable, the PRS, and the direct supervisor within 30 days of the initiation of services and shall describe how the plan for peer support services and activities will meet the individual's needs. This document shall be updated as the needs and progress of the individual change and shall document the individual's or caregiver's, as applicable, request for any changes in peer support services. The recovery, resiliency, and wellness plan is a component of the individual's overall plan of care and shall be maintained by the enrolled provider in the individual's medical record.

"Resiliency" means the ability to respond to stress, anxiety, trauma, crisis, or disaster.

"Self-advocacy" means an empowerment skill that allows the individual to effectively communicate preferences and choice.

"Strength-based" means to emphasize individual strengths, assets, and resiliencies.

"Supervision" means the ongoing process performed by a direct supervisor who monitors the performance of the PRS and provides regular documented consultation and instruction with respect to the skills and competencies of the PRS.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 34, Issue 3, eff. November 16, 2017; amended, Virginia Register Volume 37, Issue 14, eff. April 14, 2021.

12VAC30-130-5170 Peer support services and family support partners: service definitions

A. ARTS peer support services and ARTS family support partners are peer recovery support services and are nonclinical, peer-to-peer activities that engage, educate, and support an individual's, and as applicable the caregiver's, self-help efforts to improve health recovery, resiliency, and wellness. These services shall be available to either:

1. Individuals 21 years of age or older with mental health or substance use disorders or co-occurring mental health and substance use disorders that are the focus of the support; or

2. The caregiver of individuals younger than 21 years of age with mental health or substance use disorders or co-occurring mental health and substance use disorders that are the focus of the support.

3. Individuals 18 through 20 years of age who meet the medical necessity criteria set forth in 12VAC30-130-5180 A who would benefit from receiving peer supports directly, and who choose to receive ARTS peer support services directly instead of through their family shall be permitted to receive peer support services by an appropriate PRS.

B. ARTS peer support services for adults is a person centered, strength-based, and recovery-oriented rehabilitative service for individuals 21 years of age or older provided by a peer recovery specialist successful in the recovery process with lived experience with substance use disorders or co-occurring mental health and substance use disorders who is trained to offer support and assistance in helping others in recovery to reduce the disabling effects of a mental health or substance use disorder or co-occurring mental health and substance use disorder that is the focus of support. Services assist the individual with developing and maintaining a path to recovery, resiliency, and wellness. Specific peer support service activities shall emphasize the acquisition, development, and enhancement of recovery, resiliency, and wellness. Services are designed to promote empowerment, self-determination, understanding, and coping skills through mentoring and service coordination supports, as well as to assist individuals in achieving positive coping mechanisms for the stressors and barriers encountered when recovering from their illness or disorder.

C. Family support partners is a peer recovery support service and a strength-based, individualized service provided to the caregiver of a Medicaid-eligible individual younger than 21 years of age with a mental health or substance use disorder or co-occurring mental health and substance use disorder that is the focus of support. The services provided to the caregiver and the individual must be directed exclusively toward the benefit of the Medicaid-eligible individual. Services are expected to improve outcomes for an individual younger than 21 years of age with complex needs who is involved with multiple systems and increase the individual's and family's confidence and capacity to manage their own services and supports while promoting recovery and healthy relationships. These services are rendered by a PRS who is (i) a parent of a minor or adult child with a similar substance use disorder or co-occurring mental health and substance use disorder or (ii) an adult with personal experience with a family member with a similar mental health or substance use disorder or co-occurring mental health and substance use disorder with experience navigating substance use or behavioral health care services. The PRS shall perform the service within the scope of his knowledge, lived experience, and education.

D. ARTS peer recovery support services shall be rendered on an individual basis or in a group.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 34, Issue 3, eff. November 16, 2017; amended, Virginia Register Volume 35, Issue 10, eff. February 21, 2019; Volume 37, Issue 14, eff. April 14, 2021.

12VAC30-130-5180 Peer support services and family support partners: medical necessity criteria

A. In order to receive ARTS peer support services, individuals 21 years of age or older shall meet the following requirements:

1. The individual shall have a substance use disorder or co-occurring mental health and substance use disorders diagnosis.

2. The individual shall require recovery-oriented assistance and support services for:

a. The acquisition of skills needed to engage in and maintain recovery;

b. The development of self-advocacy skills to achieve a decreasing dependency on formalized treatment systems; and

c. Increasing responsibilities, wellness potential, and shared accountability for the individual's own recovery.

3. The individual shall demonstrate moderate to severe functional impairment as a result of the diagnosis, and the functional impairment shall be of a degree that it interferes with or limits performance in at least one of the following domains: educational (e.g., obtaining a high school or college degree); social (e.g., developing a social support system); vocational (e.g., obtaining part-time or full-time employment); or self-maintenance (e.g., managing symptoms, understanding his illness, living more independently).

B. Caregivers of individuals younger than 21 years of age who qualify for ARTS family support partners (i) have an individual with a substance use disorder or co-occurring mental health and substance use disorders who requires recovery assistance and (ii) meet two or more of the following:

1. Individual and his caregiver need peer-based recovery oriented services for the maintenance of wellness and acquisition of skills needed to support the individual.

2. Individual and his caregiver need assistance to develop self-advocacy skills to assist the individual in achieving self-management of the individual's health status.

3. Individual and his caregiver need assistance and support to prepare the individual for a successful work or school experience.

4. Individual and his caregiver need assistance to help the individual and caregiver assume responsibility for recovery.

C. Individuals 18 through 20 years of age who meet the medical necessity criteria in subsection A of this section, who would benefit from receiving peer supports directly, and who choose to receive peer support services directly instead of through their family shall be permitted to receive peer support services by an appropriate PRS.

D. To qualify for continued ARTS peer support services and ARTS family support partners, medical necessity criteria shall continue to be met and progress notes shall document the status of progress relative to the goals identified in the recovery resiliency and wellness plan.

E. Discharge shall occur when one or more of the following is met:

1. Goals of the recovery resiliency and wellness plan have been met;

2. The individual, or as applicable for individuals younger than 21 years of age, the caregiver, requests discharge; or

3. The individual, or as applicable for individuals younger than 21 years of age, the caregiver, fail to make minimum contact requirements set forth in 12VAC30-130-5210 L and M or the individual or caregiver, as applicable, discontinues participation in services.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 34, Issue 3, eff. November 16, 2017.

12VAC30-130-5190 Peer support services and family support partners: provider and setting requirements

A. Effective July 1, 2017, a peer recovery specialist shall have the qualifications, education, experience , and certification required by DBHDS show certification in good standing by the U.S. Department of Veterans Affairs, NAADAC - the Association of Addiction Professionals, a member board of the International Certification and Reciprocity Consortium, or any other certifying body or state certification with standards comparable to or higher than those specified by DBHDS to be eligible to register with the Board of Counseling on or after July 1, 2018. Upon the promulgation of regulations by the Board of Counseling, registration of peer recovery specialists by the Board of Counseling shall be required. in accordance with 12VAC35-250. Effective December 18, 2017, peer recovery specialists shall also be registered with the Board of Counseling.

B. Prior to service initiation, a documented assessment by a practitioner who meets the definition of "credentialed addiction treatment professional" found in 12VAC30-130-5020 and who is acting within his scope of practice under state law shall be required. A certified substance abuse counselor, as defined in § 54.1-3507.1 of the Code of Virginia, may also provide a documented assessment if he is acting under the supervision or direction of a licensed substance use treatment practitioner or licensed mental health professional. The PRS shall perform ARTS peer services under the oversight of the practitioner described in this subsection conducting the assessment and providing the clinical oversight of the recovery, resiliency, and wellness plan. The assessment shall verify that the individual meets the medical necessity criteria set forth in 12VAC30-130-5180 A or B, as applicable.

C. The PRS shall be employed by or have a contractual relationship with the enrolled provider licensed for one of the following:

1. Acute care general hospital (ASAM Level 4.0) licensed by the Department of Health as defined in 12VAC30-130-5150.

2. Freestanding psychiatric hospital or inpatient psychiatric unit (ASAM Levels 3.5 and 3.7) licensed by the Department of Behavioral Health and Developmental Services as defined in 12VAC30-130-5130 and 12VAC30-130-5140.

3. Residential placements (ASAM Levels 3.1, 3.3, 3.5, and 3.7) licensed by the Department of Behavioral Health and Developmental Services as defined in 12VAC30-130-5110 through 12VAC30-130-5140.

4. ASAM Levels 2.1 and 2.5, licensed by the Department of Behavioral Health and Developmental Services as defined in 12VAC30-130-5090 and 12VAC30-130-5100.

5. ASAM Level 1.0 as defined in 12VAC30-30-5080.

6. Opioid treatment services as defined in 12VAC30-130-5050.

7. Office-based opioid treatment as defined in 12VAC30-130-5060.

8. Hospital emergency department services licensed by the Department of Health.

9. Pharmacy services licensed by the Department of Health.

D. Only a licensed and enrolled provider referenced in subsection C of this section shall be eligible to bill and receive reimbursement from DMAS or its contractor for ARTS peer support services. Payments shall not be permitted to providers that fail to enter into an enrollment agreement with DMAS or its contractor. Reimbursement shall be subject to retraction for any billed service that is determined to not to be in compliance with DMAS requirements.

E. The direct supervisor, as defined in 12VAC30-130-5160, shall perform direct supervision of the PRS as needed based on the level of urgency and intensity of service being provided. The direct supervisor shall have an employment or contract relationship with the same provider entity that employs or contracts with the PRS. Direct supervisors shall maintain documentation of all supervisory sessions. In no instance shall supervisory sessions be performed less than as provided below:

1. If the PRS has less than 12 months of experience delivering ARTS peer support services or ARTS family support partners, he shall receive face-to-face, one-to-one supervisory meetings of sufficient length to address identified challenges for a minimum of 30 minutes, two times a month. The direct supervisor must be available at least by telephone while the PRS is on duty.

2. If the PRS has been delivering ARTS peer recovery services over 12 months and fewer than 24 months, he must receive monthly face-to-face, one-to-one supervision of sufficient length to address identified challenges for a minimum of 30 minutes. The direct supervisor must be available by telephone for consult within 24 hours of service delivery if needed for challenging situations.

F. The caseload assignment of a full-time PRS shall not exceed 15 individuals at any one time allowing for new case assignments as those on the existing caseload begin to self-manage with less support. The caseload assignment of a part-time PRS shall not exceed nine individuals at any one time. There are no minimum limits for full-time or part-time PRS caseloads.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 34, Issue 3, eff. November 16, 2017; amended, Virginia Register Volume 35, Issue 10, eff. February 21, 2019; Volume 37, Issue 14, eff. April 14, 2021.

12VAC30-130-5200 Peer support services and family support partners: documentation of required activities

A. The recommendation for services shall include the dated signature and credentials of the practitioner described in 12VAC30-130-5190 B who made the recommendation. The recommendation shall be included as part of the recovery, resiliency, and wellness plan and medical record. The recommendation shall verify that the individual meets the medical necessity criteria and shall be valid for no longer than 30 calendar days.

B. Under the clinical oversight of the practitioner making the recommendation described in 12VAC50-130-5190 B for ARTS peer support services or ARTS family support partners, the peer recovery specialist in consultation with his direct supervisor shall develop a recovery, resiliency, and wellness plan based on the recommendation for service, the individual's, and, as applicable the caregiver's, perceived recovery needs and multidisciplinary assessment as defined in this section within 30 calendar days of the initiation of service. Development of the recovery, resiliency, and wellness plan shall include collaboration with the individual and, as applicable, the identified family member or caregiver involved in the individual's recovery. Individualized goals and strategies shall be focused on the individual's identified needs for self-advocacy and recovery. The recovery, resiliency, and wellness plan shall also include documentation of how many days per week and how many hours per week are required to carry out the services in order to meet the goals of the plan. The recovery, resiliency, and wellness plan shall be completed, signed, and dated by the practitioner making the recommendation, the PRS, the direct supervisor, the individual, and, as applicable, the identified family member or caregiver involved in the individual's recovery within 30 calendar days of the initiation of service. The PRS shall act as an advocate for the individual, encouraging the individual, and as applicable the caregiver, to take a proactive role in developing and updating goals and objectives in the individualized recovery planning.

C. Services shall be delivered in accordance with the individual's goals and objectives as identified in the recovery, resiliency, and wellness plan and consistent with the recommendation of the referring practitioner who recommended services. As determined by the goals identified in the recovery, resiliency, and wellness plan, services may be rendered in the provider's office or in the community, or both. The level of services provided and total time billed by the enrolled provider for the week shall not exceed the frequency established in the recovery, resiliency, and wellness plan.

D. Under the clinical oversight of the practitioner described in 12VAC30-130-5190 B making the recommendation, the peer recovery specialist in consultation with his direct supervisor shall conduct and document a review of the recovery, resiliency, and wellness plan every 90 calendar days with the individual and the caregiver, as applicable. The review shall be signed by the PRS and the individual and, as applicable, the identified family member or caregiver. Review of the recovery, resiliency, and wellness plan means the PRS evaluates and updates the individual's progress every 90 days toward meeting the plan's goals and documents the outcome of this review in the individual's medical record. For DMAS to determine that these reviews are complete, the reviews shall (i) update the goals and objectives as needed to reflect any change in the individual's recovery as well as any newly identified needs, (ii) be conducted in a manner that enables the individual to actively participate in the process, and (iii) be documented by the PRS in the individual's medical record no later than 15 calendar days from the date of the review.

E. Progress notes as defined in 12VAC30-50-130 shall be required and shall record the date, time, place of service, participants, face-to-face or telephone contact, and circumstance of contact, regardless of whether or not a billable service was provided, and shall summarize the purpose and content of the session along with the specific strategies and activities utilized as related to the goals in the recovery, resiliency, and wellness plan. Documentation of specific strategies and activities shall fully disclose the details of services rendered and align with the recovery, resiliency, and wellness plan. Strategies and activities shall include at a minimum:

1. Person centered, strength-based planning to promote the development of self-advocacy skills;

2. Empowering the individual to take a proactive role in the development and updating of his recovery, resiliency, and wellness plan;

3. Crisis support; and

4. Assisting in the use of positive self-management techniques, problem‐solving skills, coping mechanisms, symptom management, and communication strategies identified in the recovery, resiliency, and wellness plan so that the individual:

a. Remains in the least restrictive setting;

b. Achieves his goals and objectives identified in the recovery resiliency and wellness plan;

c. Self-advocates for quality physical and behavioral health services; and

d. Has access to strength-based behavioral health services, social services, educational services, and other supports and resources.

F. Progress notes shall reflect collaboration between the PRS and the individual in the development of the progress notes. If contact with the individual cannot be made, the service is not billable. However, the progress notes shall reflect attempts to contact the individual. Progress notes shall contain the dated signature of the PRS who provided the service.

G. The enrolled provider shall ensure that documentation of all supervision sessions is maintained in a supervisor's log or the personnel file of the PRS.

H. The enrolled provider shall have oversight of the individual's record and maintain individual records in accordance with state and federal requirements. The enrolled provider shall ensure documentation of all activities and documentation of all relevant information about the Medicaid individuals receiving services. Such documentation shall fully disclose the extent of services provided in order to support providers claims for reimbursement for services rendered. This documentation shall be written, signed, and dated at the time the services are rendered.

I. The enrolled provider may integrate an individual's peer support record with the individual's other records maintained within same provider agency or facility, provided all peer support documentation is clearly identified. Logs and progress notes documenting the provision of services shall corroborate billed services.

J. Collaboration shall be required with behavioral health service providers and shall include the PRS and the individual, or caregiver as applicable, and shall involve discussion regarding initiation of services and updates on the individual's status and changes in the individual's progress. Documentation of all collaboration shall be maintained in the individual's record.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 34, Issue 3, eff. November 16, 2017.

12VAC30-130-5210 Peer support services and family support partners: limitations and exclusions to service delivery

A. An approved service authorization submitted by the enrolled provider shall be required prior to service delivery in order for reimbursement to occur. To obtain service authorization, all provider information supplied to the Department of Medical Assistance Services or its contractor shall be fully substantiated throughout the individual's record.

B. Service shall be initiated within 30 calendar days of the documented recommendation. The recommendation shall be valid for no longer than 30 calendar days.

C. Services rendered in a group setting shall have a ratio of no more than 10 individuals to one PRS, and progress notes shall be included in each individual's record.

D. General support groups that are made available to the public to promote education and global advocacy do not qualify as peer support services or family support partners.

E. Noncovered activities include transportation, recordkeeping or documentation activities (including progress notes, tracking hours and billing, and other administrative paperwork), services performed by volunteers, household tasks, chores, grocery shopping, on-the-job training, case management, outreach to potential clients, and room and board.

F. A unit of service shall be defined as 15 minutes. Peer support services and family support partners shall be limited to four hours per day (up to 16 units per calendar day) and 900 hours per calendar year. Service delivery limits may be exceeded based upon documented medical necessity and service authorization approval.

G. If a service recommendation for mental health peer support services or mental health family support partners as set forth in 12VAC30-50-130 or 12VAC30-50-226 is made in addition to a service recommendation for ARTS peer support services or ARTS family support partners as set forth in 12VAC30-130-5160 through 12VAC30-130-5210, the enrolled provider shall coordinate services to ensure the four-hour daily service limit is not exceeded. No more than a total of four hours of one type of service, or a total of four hours of a combination of service types, up to 16 units of total service, shall be provided per calendar day. The enrolled provider cannot bill DMAS separately for (i) mental health peer services (mental health peer support services or mental health family support partners) and (ii) ARTS peer services (peer support services or ARTS family support partners) rendered on the same calendar day unless the mental health peer services and ARTS peer services are rendered at different times. A separate annual service limit of up to 900 hours shall apply to mental health peer support services or mental health family support partners service and ARTS peer support services or ARTS family support partners.

H. The PRS shall document each 15-minute unit in which the individual was actively engaged in peer support services or family support partners. Meals and breaks and other noncovered services listed in this section shall not be included in the reporting of units of service delivered. Should an individual receive other services during the range of documented time in/time out for peer support hours, the absence of or interrupted services must be documented.

I. Service delivery shall be based on the individual's identified needs, established medical necessity criteria, and goals identified in the individual recovery resiliency and wellness plan.

J. Billing shall occur only for services provided with the individual present. Telephone time is supplemental rather than replacement of face-to-face contact and is limited to 25% or less of total time per recipient per calendar year. Justification for services rendered with the individual via telephone shall be documented. Any telephone time rendered over the 25% limit will be subject to retraction.

K. Peer support services or family support partners may operate in the same building as other day services; however, there must be a distinct separation between services in staffing, program description, and physical space. Peer support services shall be an ancillary service and shall not impede, interrupt, or interfere with the provision of the primary service setting.

L. Contact shall be made with the individual receiving peer support services or family support partners a minimum of twice each month. At least one of these contacts must be face-to-face and the second may be either face-to-face or telephone contact depending on the individual's support needs and documented preferences.

M. In the absence of the required monthly face-to-face contact and if at least two unsuccessful attempts to make face-to-face contact have been tried and documented, the provider may bill for a maximum of two telephone contacts in that specified month, not to exceed two units. After two consecutive months of unsuccessful attempts to make face-to-face contact, discharge shall occur.

N. Family support partners is not billable for siblings of the targeted individual for whom a need is specified unless there is applicability to the targeted individual or family. The applicability to the targeted individual must be documented.

O. Family support partners services shall not be billed for an individual who resides in a congregate setting in which the caregivers are paid, such as child caring institutions or any other living environment that is not comprised of more permanent caregivers. An exception would be for an individual actively preparing for transition back to a single-family unit, the caregiver is present during the intervention, and the service is directed to supporting the unification or reunification of the individual and his caregiver and takes place in that home and community. The circumstances surrounding the exception shall be documented.

P. Individuals with the following conditions are excluded from family support partners unless there is clearly documented evidence and diagnosis of a substance use disorder or mental health disorder overlaying the diagnosis: developmental disability including intellectual disabilities, organic mental disorder including dementia or Alzheimer's, or traumatic brain injury. There must be documented evidence that the individual is able to participate in the service and benefit from family support partners.

Q. Claims that are not adequately supported by appropriate up-to-date documentation may be subject to recovery of expenditures. Progress notes, as defined in 12VAC30-50-130, shall disclose the extent of services provided and corroborate the units billed. Claims not supported by corroborating progress notes shall be subject to recovery of expenditures.

R. The enrolled provider shall be subject to utilization reviews conducted by DMAS or its designated contractor.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 34, Issue 3, eff. November 16, 2017.

Chapter 135 Demonstration Waivers (Repealed) [Repealed]

Part I (Repealed)

12VAC30-135-10 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 25, eff. October 1, 2003; amended, Virginia Register Volume 23, Issue 21, eff. November 1, 2007; Volume 24, Issue 26, eff. October 16, 2008; repealed, Virginia Register Volume 33, Issue 11, eff. February 22, 2017.

12VAC30-135-20 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 25, eff. October 1, 2003; amended, Virginia Register Volume 23, Issue 21, eff. November 1, 2007; Volume 24, Issue 26, eff. October 16, 2008; repealed, Virginia Register Volume 33, Issue 11, eff. February 22, 2017.

12VAC30-135-30 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 25, eff. October 1, 2003; amended, Virginia Register Volume 23, Issue 21, eff. November 1, 2007; Volume 24, Issue 26, eff. October 16, 2008; repealed, Virginia Register Volume 33, Issue 11, eff. February 22, 2017.

12VAC30-135-40 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 25, eff. October 1, 2003; amended, Virginia Register Volume 23, Issue 21, eff. November 1, 2007; Volume 24, Issue 26, eff. October 16, 2008; repealed, Virginia Register Volume 33, Issue 11, eff. February 22, 2017.

12VAC30-135-50 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 25, eff. October 1, 2003; repealed, Virginia Register Volume 33, Issue 11, eff. February 22, 2017.

12VAC30-135-60 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 25, eff. October 1, 2003; repealed, Virginia Register Volume 33, Issue 11, eff. February 22, 2017.

12VAC30-135-70 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 25, eff. October 1, 2003; amended, Virginia Register Volume 24, Issue 26, eff. October 16, 2008; repealed, Virginia Register Volume 33, Issue 11, eff. February 22, 2017.

12VAC30-135-80 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 25, eff. October 1, 2003; amended, Virginia Register Volume 23, Issue 21, eff. November 1, 2007; repealed, Virginia Register Volume 33, Issue 11, eff. February 22, 2017.

12VAC30-135-90 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 25, eff. October 1, 2003; repealed, Virginia Register Volume 33, Issue 11, eff. February 22, 2017.

12VAC30-135-100 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 24, Issue 2, eff. December 1, 2007; repealed, Virginia Register Volume 35, Issue 24, eff. August 21, 2019.

12VAC30-135-110 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 24, Issue 2, eff. December 1, 2007; repealed, Virginia Register Volume 35, Issue 24, eff. August 21, 2019.

12VAC30-135-120 (Repealed.)

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 2, eff. December 1, 2007; repealed, Volume 35, Issue 24, eff. August 21, 2019.

12VAC30-135-130 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 24, Issue 2, eff. December 1, 2007; repealed, Virginia Register Volume 35, Issue 24, eff. August 21, 2019.

12VAC30-135-140 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 24, Issue 2, eff. December 1, 2007; Volume 26, Issue 19, eff. July 1, 2010; repealed, Volume 35, Issue 24, eff. August 21, 2019.

12VAC30-135-150 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 24, Issue 2, eff. December 1, 2007; repealed, Virginia Register Volume 35, Issue 24, eff. August 21, 2019.

12VAC30-135-160 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 24, Issue 2, eff. December 1, 2007; repealed, Virginia Register Volume 35, Issue 24, eff. August 21, 2019.

12VAC30-135-170 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 24, Issue 2, eff. December 1, 2007; repealed, Virginia Register Volume 35, Issue 24, eff. August 21, 2019.

12VAC30-135-180 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 24, Issue 2, eff. December 1, 2007; repealed, Virginia Register Volume 35, Issue 24, eff. August 21, 2019.

12VAC30-135-190 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 24, Issue 2, eff. December 1, 2007; repealed, Virginia Register Volume 35, Issue 24, eff. August 21, 2019.

12VAC30-135-200 (Repealed.)

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 2, eff. December 1, 2007; amended, Virginia Register Volume 27, Issue 19, eff. July 1, 2011; repealed, Virginia Register Volume 35, Issue 24, eff. August 21, 2019.

12VAC30-135-210 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 24, Issue 2, eff. December 1, 2007; repealed, Virginia Register Volume 35, Issue 24, eff. August 21, 2019.

12VAC30-135-220 (Repealed.)

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 2, eff. December 1, 2007; amended, Virginia Register Volume 27, Issue 19, eff. July 1, 2011; repealed, Virginia Register Volume 35, Issue 24, eff. August 21, 2019.

12VAC30-135-230 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 24, Issue 2, eff. December 1, 2007; repealed, Virginia Register Volume 35, Issue 24, eff. August 21, 2019.

12VAC30-135-240 (Repealed.)

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 2, eff. December 1, 2007; repealed, Virginia Register Volume 35, Issue 24, eff. August 21, 2019.

12VAC30-135-250 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 24, Issue 2, eff. December 1, 2007; repealed, Virginia Register Volume 35, Issue 24, eff. August 21, 2019.

12VAC30-135-260 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 24, Issue 2, eff. December 1, 2007; repealed, Virginia Register Volume 35, Issue 24, eff. August 21, 2019.

12VAC30-135-270 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 24, Issue 2, eff. December 1, 2007; repealed, Virginia Register Volume 35, Issue 24, eff. August 21, 2019.

12VAC30-135-280 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 24, Issue 2, eff. December 1, 2007; repealed, Virginia Register Volume 35, Issue 24, eff. August 21, 2019.

12VAC30-135-290 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 24, Issue 2, eff. December 1, 2007; repealed, Virginia Register Volume 35, Issue 24, eff. August 21, 2019.

12VAC30-135-300 (Repealed.)

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 2, eff. December 1, 2007; repealed, Virginia Register Volume 35, Issue 24, eff. August 21, 2019.

12VAC30-135-310 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 24, Issue 2, eff. December 1, 2007; repealed, Virginia Register Volume 35, Issue 24, eff. August 21, 2019.

12VAC30-135-320 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 24, Issue 2, eff. December 1, 2007; repealed, Virginia Register Volume 35, Issue 24, eff. August 21, 2019.

12VAC30-135-330 (Reserved.)

Historical Notes

Derived from Virginia Register Volume 24, Issue 2, eff. December 1, 2007.

12VAC30-135-340 (Repealed.)

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 24, Issue 2, eff. December 1, 2007; repealed, Virginia Register Volume 35, Issue 24, eff. August 21, 2019.

12VAC30-135-350 (Reserved.)

Historical Notes

Derived from Virginia Register Volume 24, Issue 2, eff. December 1, 2007.

12VAC30-135-360 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 24, Issue 2, eff. December 1, 2007; repealed, Virginia Register Volume 35, Issue 24, eff. August 21, 2019.

Part III Governor's Access Plan Demonstration Waiver for Individuals with Serious Mental Illness

12VAC30-135-400 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 34, Issue 10, eff. February 7, 2018; repealed, Virginia Register Volume 37, Issue 24, eff. September 2, 2021.

12VAC30-135-410 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 34, Issue 10, eff. February 7, 2018; repealed, Virginia Register Volume 37, Issue 24, eff. September 2, 2021.

12VAC30-135-420 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 34, Issue 10, eff. February 7, 2018; repealed, Virginia Register Volume 37, Issue 24, eff. September 2, 2021.

12VAC30-135-430 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 34, Issue 10, eff. February 7, 2018; repealed, Virginia Register Volume 37, Issue 24, eff. September 2, 2021.

12VAC30-135-440 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 34, Issue 10, eff. February 7, 2018; repealed, Virginia Register Volume 37, Issue 24, eff. September 2, 2021.

12VAC30-135-450 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 34, Issue 10, eff. February 7, 2018; repealed, Virginia Register Volume 37, Issue 24, eff. September 2, 2021.

12VAC30-135-460 (Repealed.)

History

• Historical Notes: Reserved, Virginia Register Volume 34, Issue 10, eff. February 7, 2018; repealed, Virginia Register Volume 37, Issue 24, eff. September 2, 2021.

12VAC30-135-470 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 34, Issue 10, eff. February 7, 2018; repealed, Virginia Register Volume 37, Issue 24, eff. September 2, 2021.

12VAC30-135-475 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 34, Issue 10, eff. February 7, 2018; repealed, Virginia Register Volume 37, Issue 24, eff. September 2, 2021.

12VAC30-135-480 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 34, Issue 10, eff. February 7, 2018; repealed, Virginia Register Volume 37, Issue 24, eff. September 2, 2021.

12VAC30-135-485 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 34, Issue 10, eff. February 7, 2018; repealed, Virginia Register Volume 37, Issue 24, eff. September 2, 2021.

12VAC30-135-487 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 34, Issue 10, eff. February 7, 2018; repealed, Virginia Register Volume 37, Issue 24, eff. September 2, 2021.

12VAC30-135-489 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 34, Issue 10, eff. February 7, 2018; repealed, Virginia Register Volume 37, Issue 24, eff. September 2, 2021.

12VAC30-135-491 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 34, Issue 10, eff. February 7, 2018; repealed, Virginia Register Volume 37, Issue 24, eff. September 2, 2021.

12VAC30-135-494 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 34, Issue 10, eff. February 7, 2018; repealed, Virginia Register Volume 37, Issue 24, eff. September 2, 2021.

12VAC30-135-495 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 34, Issue 10, eff. February 7, 2018; repealed, Virginia Register Volume 37, Issue 24, eff. September 2, 2021.

12VAC30-135-496 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 34, Issue 10, eff. February 7, 2018; repealed, Virginia Register Volume 37, Issue 24, eff. September 2, 2021.

12VAC30-135-498 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 34, Issue 10, eff. February 7, 2018; repealed, Virginia Register Volume 37, Issue 24, eff. September 2, 2021.

Chapter 141 Family Access to Medical Insurance Security Plan

Part I General Provisions

12VAC30-141-10 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Adverse action," consistent with 42 CFR 457.1130, means the denial of eligibility; failure to make a timely determination of eligibility; suspension or termination of enrollment, including disenrollment for failure to pay cost sharing; or delay, denial, reduction, suspension, or termination of health services, in whole or in part, including a determination about the type or level of services; and failure to approve, furnish, or provide payment for health services in a timely manner; provided, however, that determination of eligibility to participate in and termination of participation in the FAMIS Select program shall not constitute an adverse action.

"Adverse benefit determination," consistent with 42 CFR 438.400, means the denial or limited authorization of a requested service; the failure to take action or timely take action on a request for service; the reduction, suspension, or termination of a previously authorized service; denial in whole or in part of a payment for a service; failure to provide services within the timeframes required by the state; for a resident of a rural exception area with only one MCO, the denial of a enrollee's request to exercise the enrollee's right under 42 CFR 438.52(b)(2)(ii) to obtain services outside of the network; the denial of a enrollee's request to dispute a financial liability as provided in 42 CFR 438.400(b)(7); or the failure of an MCO to act within the timeframes provided in 42 CFR 438.408(b).

"Agency" means a local department of social services, the central processing unit, or other entity designated by DMAS to make eligibility determinations for FAMIS.

"Agent" means an individual designated in writing to act on behalf of a FAMIS Plan applicant or enrollee during the administrative review process.

"Appeal" means an enrollee's request for review of an adverse benefit determination by an MCO or an adverse action by the LDSS, CPU, or DMAS.

"Applicant" means a child who has filed an application (or who has an application filed on his behalf) for child health insurance and is awaiting a determination of eligibility. A child is an applicant until his eligibility has been determined.

"Application for health insurance" means the. single streamlined application for determining eligibility in public health insurance programs operated by the Commonwealth.

"Authorized representative" means a person, 18 years of age or older, who is authorized to conduct the personal or financial affairs for an individual.

"Central processing unit" or "CPU" means Cover Virginia, which is the centralized entity supported by DMAS to accept and act on applications for health insurance.

"Child" means an individual younger than 19 years of age.

"Conservator" means a person appointed by a court of competent jurisdiction to manage the estate and financial affairs of an incapacitated individual.

"Continuation of coverage" means ensuring an enrollee's benefits are continued until completion of the review process, with the condition that should the enrollee not prevail in the review process, the enrollee shall be liable for the repayment of all benefits received during the review process.

"Director" means the individual, or his designee, specified in § 32.1-324 of the Code of Virginia with all of the attendant duties and responsibilities to administer the State Plan for Medical Assistance and the State Plan for FAMIS.

"DMAS" or "department" means the Department of Medical Assistance Services.

"Ex parte review" means the review of administratively available information pertinent to the application or renewal process, conducted by eligibility staff, in order to expediently process the applicant's renewal without seeking that information from the applicant.

"Family," when used in the context of the FAMIS Select component, means a unit or group that has access to a private or employer's group health plan. Thus, it includes the policyholder or employee and any dependents who can be covered under the plan.

"FAMIS" means the Family Access to Medical Insurance Security Plan.

"FAMIS Select" means an optional program available to children determined eligible for FAMIS, whereby DMAS provides premium assistance to the family to cover the child through a private or employer-sponsored health plan instead of directly through the FAMIS program.

"Federal poverty level" or "FPL" means that income standard as published annually by the U.S. Department of Health and Human Services in the Federal Register.

"Fee-for-service" means the traditional Medicaid health care delivery and payment system in which physicians and other providers receive a payment for each unit of service they provide.

"Fixed premium assistance amount" means a predetermined amount of premium assistance that DMAS will pay per child to a family who chooses to enroll its FAMIS eligible child in a private or employer-sponsored health plan. The fixed premium assistance amount will be determined annually by DMAS to ensure that the FAMIS Select program is cost-effective as compared to the cost of covering a child directly through the FAMIS program.

"Guardian" means a person appointed by a court of competent jurisdiction to be responsible for the affairs of an incapacitated individual, including responsibility for making decisions regarding the person's support, care, health, safety, habilitation, education, and therapeutic treatment, and if not inconsistent with an order of commitment, residence.

"Household" means the household composition and follows the federal tax rules through the use of modified adjusted gross income (MAGI) methodology. An individual's household is based upon the tax filing relationships of applicant, persons living with the individual, and those claimed as dependents and as outlined in 42 USC § 435.603(3)(f)(1) through (f)(4).

"Household income" means the sum of MAGI-based income as outlined in 42 USC § 435.603(3)(d) through (3)(e) to include every individual in the household.

"Internal appeal" means a request to the MCO by an enrollee, an enrollee's authorized representative, or a provider, acting on behalf of the enrollee and with the enrollee's written consent, for review of an MCO's adverse benefit determination. The internal appeal is the only level of appeal with the MCO and must be exhausted by an enrollee or deemed exhausted according to 42 CFR 438.408(c)(3) before the enrollee may initiate a state fair hearing.

"Lawfully residing" means the individual is lawfully present in the United States.

"LDSS" or "local department" means the local department of social services.

"Managed care organization" or "MCO" means an organization that offers managed care health insurance plans (MCHIPs) as "MCHIP" is defined in § 32.1-137.1 of the Code of Virginia.

"Premium assistance" means the portion of the family's cost of participating in a private or employer's health plan that DMAS will pay to cover the FAMIS-eligible children under the private or employer-sponsored plan if DMAS determines it is cost effective to do so.

"Private or employer-sponsored health plan" means a health insurance policy that is either purchased by an individual directly or through an employer. This component of FAMIS refers to the ability of DMAS to provide coverage to FAMIS-eligible children by providing premium assistance to families who enroll the FAMIS-eligible children in a private or employer-sponsored health plan.

"Provider" means the individual, facility or other entity registered, licensed, or certified, as appropriate, and enrolled by an MCHIP or in fee-for-service to render services to FAMIS enrollees eligible for services.

"Reasonable opportunity period" means a 90-calendar-day period given to applicants to supply verification of citizenship and identity.

"State fair hearing" means, consistent with 42 CFR 438.400, the process set forth in 42 CFR 431 Subpart E.

"Targeted low-income child" means an uninsured child younger than age 19 years whose household income is within the FAMIS eligibility standards established by the Commonwealth.

"Title XXI" means the federal State Children's Health Insurance Program as established by Subtitle J of the Balanced Budget Act of 1997.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 21, eff. August 1, 2003; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006; Volume 23, Issue 7, eff. January 10, 2007; Volume 30, Issue 12, eff. March 28, 2014; Volume 35, Issue 20, eff. June 26, 2019.

12VAC30-141-20 Administration and general background

A. The state shall use funds provided under Title XXI for obtaining coverage that meets the requirements for a State Child Health Insurance Plan (also known as Title XXI).

B. The DMAS director will have the authority to contract with entities for the purpose of establishing a centralized processing site, determining eligibility, enrolling eligible children into health plans, performing outreach, data collection, reporting, and other services necessary for the administration of the Family Access to Medical Insurance Security Plan.

C. Health care services under FAMIS shall be provided through MCHIPs and through fee-for-service or through any other health care delivery system deemed appropriate by the Department of Medical Assistance Services.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 21, eff. August 1, 2003; amended, Virginia Register Volume 30, Issue 12, eff. March 28, 2014; Volume 35, Issue 20, eff. June 26, 2019.

12VAC30-141-30 Outreach and public participation

A. DMAS will work cooperatively with other state agencies and contractors to ensure that federal law and any applicable federal regulations are met.

B. DMAS shall develop a comprehensive marketing and outreach effort. The marketing and outreach efforts will be aimed at promoting the FAMIS and Medicaid programs and increasing enrollment and may include contracting with a public relations firm, nonprofit agencies, and foundations; coordination with other state agencies; coordination with the business community; and coordination with health care associations and providers.

C. DMAS shall ensure consultation by Native American tribes on the development and implementation of enrollment processes and procedures to exempt cost-sharing for American Indian and Alaskan Native children in compliance with 42 CFR 457.120 and 42 CFR 457.125.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 21, eff. August 1, 2003; amended, Virginia Register Volume 35, Issue 20, eff. June 26, 2019.

Part II Appeal of Adverse Actions

12VAC30-141-40 Appeal of adverse actions or adverse benefit determinations

A. Upon written request, all FAMIS applicants and enrollees shall have the right to a state fair hearing of an adverse action made by the local department of social services, CPU, or DMAS and to an internal appeal of an adverse benefit determination made by an MCO.

B. During the appeal of a suspension or termination of enrollment or a reduction, suspension, or termination of services, the enrollee shall have the right to continuation of coverage if the enrollee requests an internal appeal with the MCO or an appeal to DMAS prior to the effective date of the suspension or termination of enrollment or suspension, reduction, or termination of services.

C. An appeal of an adverse action made by the local department of social services, CPU, or DMAS shall be heard and decided by an agent of DMAS who has not been directly involved in the adverse action under appeal.

D. An internal appeal of an adverse benefit determination made by the MCO must be conducted by a person or agent of the MCO who has not been directly involved in the adverse benefit determination under appeal.

E. Pursuant to 42 CFR 438.402(c)(1)(B), after exhausting the MCO's internal appeals process, there shall be opportunity for the enrollee to request an external medical review by an independent external quality review organization. "External quality review organization" means the independent contractor assigned by DMAS to handle quality reviews and to conduct final review of MCHIP adverse actions for FAMIS. The review is optional and shall not be required before proceeding to a state fair hearing. The review shall not extend any of the timeframes for issuing a decision and shall not disrupt any continuation of coverage granted to the enrollee.

F. There will be no opportunity for appeal of an adverse action to the extent that such adverse action is based on a determination by the director that funding for FAMIS has been terminated or exhausted. There will be no opportunity for appeal if the sole basis for the decision is a provision in the State Plan or in a state or federal law requiring an automatic change in eligibility or enrollment or is a change in coverage under the health benefits package that affects all applicants or enrollees or a group of applicants or enrollees without regard to their individual circumstances.

G. The burden of proof shall be assigned to the party who is attempting to make a change per 12VAC30-110-220 C .

H. At no time shall the failure of the local department of social services, MCO, CPU, or DMAS to meet the timeframes set in this chapter or set in the MCO or DMAS written appeal procedures constitute a basis for granting the applicant or enrollee the relief sought.

I. Adverse actions related to health benefits covered through the FAMIS Select program shall be resolved between the insurance company or employer's plan and the FAMIS Select enrollee and are not subject to further appeal by DMAS or its contractors.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 21, eff. August 1, 2003; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006; Volume 35, Issue 20, eff. June 26, 2019; Volume 40, Issue 22, eff. August 1, 2024.

12VAC30-141-50 Notice of adverse action or adverse benefit determination

A. The local department of social services, CPU, or DMAS shall send written notification to enrollees at least 10 calendar days prior to suspension or termination of enrollment.

B. DMAS or the MCO shall send written notification to enrollees at least 10 calendar days prior to reduction, suspension, or termination of a previously authorized health service.

C. The local department of social services, CPU, DMAS, or the MCO shall send written notification to applicants and enrollees of all other adverse actions within 10 calendar days of the adverse action.

D. Notice shall include:

1. The determination the LDSS, CPU, DMAS, or MCO has made or intends to make;

2. The reasons for the determination, including the right of the enrollee to be provided, upon request and free of charge, reasonable access to and copies of all documents, records, and other information relevant to the determination;

3. An explanation of applicable rights to request an appeal of that determination. For adverse benefit determinations by an MCO, this shall include information on the MCO's internal appeal process and, after the internal appeal process is exhausted, a state fair hearing pursuant to 42 CFR 402(b) and 42 CFR 402(c);

4. The procedure for exercising these appeal rights;

5. The circumstances under which an appeal process can be expedited and how to request it; and

6. The circumstances under which enrollment or services may continue pending appeal, how to request benefits be continued, and the circumstances, consistent with state policy, under which the enrollee may be required to pay the costs of these services.

History

• Statutory Authority: §32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 21, eff. August 1, 2003; amended, Virginia Register Volume 35, Issue 20, eff. June 26, 2019.

12VAC30-141-60 Request for appeal

A. Requests for internal appeal of MCO adverse benefit determinations shall be submitted orally or in writing to the MCO. Unless the enrollee requests an expedited appeal, an oral appeal request must be followed by a written appeal request. The enrollee must exhaust the MCO's internal appeals process before appealing to DMAS.

B. If the MCO fails to adhere to the notice or timing requirements set forth in this part, the enrollee is deemed to have exhausted the MCO's internal appeals process and may initiate a state fair hearing.

C. Requests for appeal of adverse actions made by the local department of social services, CPU, or DMAS or of internal appeal decisions by the MCO shall be submitted to DMAS.

D. Any communication expressing a desire to have an adverse benefit determination by an MCO reviewed shall be treated as a request for an internal appeal. Any communication expressing a desire to have an adverse action by the LDSS, CPU, or DMAS reviewed shall be treated as a request for a state fair hearing. Any communication expressing a desire to have an MCO's internal appeal decision reviewed shall be treated as a request for a state fair hearing.

E. To be timely, requests for internal appeal of an MCO's adverse benefit determination shall be received by the MCO no later than 60 calendar days from the date of the MCO's notice of adverse benefit determination.

F. To be timely, a request for an appeal of an adverse benefit determination upheld in whole or in part by the MCO's internal appeal decision shall be received by DMAS within 120 calendar days from the date of the internal appeal decision.

G. To be timely, requests for appeal of a local department of social services, DMAS, or CPU adverse action shall be filed with DMAS no later than 30 calendar days from the date of the notice of adverse action. Requests for appeal of an agency determination shall be considered filed with DMAS on the date the request is postmarked if mailed, or on the date the request is received if delivered other than by mail, by DMAS.

History

• Statutory Authority: §32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 21, eff. August 1, 2003; amended, Virginia Register Volume 25, Issue 14, eff. April 15, 2009; Volume 35, Issue 20, eff. June 26, 2019.

12VAC30-141-70 Appeal procedures

A. At a minimum, the MCO internal appeal shall be conducted pursuant to written procedures as defined in § 32.1-137.6 of the Code of Virginia and 42 CFR 438.400 et seq. Such procedures shall be subject to review and approval by DMAS.

B. Any adverse benefit determination upheld in whole or in part by the internal appeal decision issued by the MCO may be appealed by the enrollee to DMAS in accordance with the DMAS client appeals regulations at 12VAC30-110-10 through 12VAC30-110-370. DMAS shall conduct an evidentiary hearing in accordance with the 12VAC30-110-10 through 12VAC30-110-370 and shall not base any appealed decision on the record established by any internal appeal decision of the MCO. The MCO shall comply with the DMAS appeal decision. The DMAS decision in these matters shall be final and shall not be subject to appeal by the MCO.

C. Appeals of adverse actions by the LDSS, CPU, or DMAS shall be conducted pursuant to 12VAC30-110.

D. Copies of the procedures shall be promptly provided by the MCO or DMAS to applicants and enrollees upon receipt of timely requests for internal appeals or state fair hearings. Such written procedures shall include the following:

1. The right to representation by an attorney or other agent of the applicant's or enrollee's choice, but at no time shall the MCO, local department of social services, DSS, or DMAS be required to obtain or compensate attorneys or other agents acting on behalf of applicants or enrollees;

2. The right to timely review of files and other applicable information relevant to the internal appeal or state fair hearing decision;

3. The right to fully participate in the internal appeal or state fair hearing process, whether the internal appeal or state fair hearing is conducted in person or in writing, including the presentation of supplemental information during the internal appeal or state fair hearing process;

4. The right to have personal and medical information and records maintained as confidential;

5. The right to a written final decision:

a. For internal appeals to the MCO, within 30 calendar days of receipt of the request for an internal appeal; or

b. For state fair hearings, within the time limitations for appeals imposed by federal regulations and as permitted in 12VAC30-110-30;

6. For eligibility and enrollment matters, if the applicant's or enrollee's physician or health plan determines that the 90-calendar-day timeframe could seriously jeopardize the applicant's or enrollee's life or health or ability to attain, maintain, or regain maximum function, an applicant or enrollee will have the opportunity to request an expedited appeal. Under these conditions, a request for an expedited appeal shall result in a written final decision within 72 hours after DMAS receives the expedited appeal request from the physician or health plan with the case record and information indicating that taking the time for a standard resolution of the appeal request could seriously jeopardize the applicant's or enrollee's life or health or ability to attain, maintain, or regain maximum function, unless the applicant or enrollee requests an extension;

7. For health services matters for FAMIS enrollees receiving services through an MCO:

a. If the enrollee's physician or health plan determines that the 30-calendar-day timeframe for a standard internal appeal could seriously jeopardize the enrollee's life or health or ability to attain, maintain, or regain maximum function, an enrollee will have the opportunity to request an expedited internal appeal. Under these conditions, a request for an internal appeal shall result in a written decision by the MCO within 72 hours from the time the expedited internal appeal is requested, unless the applicant, enrollee, or authorized representative requests a delay. If a delay is requested by the applicant, enrollee, or authorized representative, then the expedited internal appeal may be extended up to 14 calendar days.

b. If the adverse benefit determination is upheld in whole or in part by the expedited internal appeal decision issued by the MCO, and if the enrollee's physician or health plan determines that the timeframe for a standard appeal to DMAS could seriously jeopardize the enrollee's life or health or ability to attain, maintain, or regain maximum function, and enrollee will have the opportunity to request an expedited appeal to DMAS. Under these conditions, a request for a state fair hearing shall result in a written decision within 72 hours from the time an enrollee requests the expedited appeal, unless the applicant, enrollee, or authorized representative requests a delay. If a delay is requested by the applicant, enrollee, or authorized representative, then the expedited appeal may be extended up to 14 calendar days; and

8. For health services matters for FAMIS enrollees receiving services through fee-for-service, if the enrollee's physician or health plan determines that the 90-calendar-day timeframe for a standard appeal could seriously jeopardize the enrollee's life, health, or ability to attain, maintain, or regain maximum function, an enrollee will have the opportunity to request an expedited review. Under these conditions, a request for an expedited appeal shall result in a written decision within 72 hours from the time the expedited appeal is requested, unless the applicant, enrollee, or authorized representative requests a delay. If a delay is requested by the applicant, enrollee, or authorized representative, then expedited appeal may be extended up to 14 calendar days.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 21, eff. August 1, 2003; amended, Virginia Register Volume 30, Issue 12, eff. March 28, 2014; Volume 35, Issue 20, eff. June 26, 2019.

12VAC30-141-80 [Reserved]

Historical Notes

Derived from Virginia Register Volume 19, Issue 21, eff. August 1, 2003.

Part III Eligibility Determination and Application Requirements

12VAC30-141-100 General conditions of eligibility

A. An LDSS, DMAS, or the CPU determines eligibility for Title XXI services.

B. FAMIS shall be in effect statewide.

C. FAMIS serves targeted low-income children consistent with requirements at 42 CFR 457.310, 42 CFR 457.315, and 42 CFR 457.320.

D. Each individual covered under the plan shall be:

1. Financially eligible to receive services as established using the methods and standards described in subsection F of this section; and

2. Meet the applicable nonfinancial eligibility conditions.

E. Nonfinancial eligibility conditions.

1. Eligible individuals shall be younger than 19 years of age.

2. Eligible individuals shall be residents of the Commonwealth. A child is considered to be a resident of the Commonwealth under the following conditions:

a. A noninstitutionalized child if capable of indicating intent and who is emancipated or married if the child is living in the state and intends to reside in the state, including without a fixed address;

b. A noninstitutionalized child not described in subdivision E 2 a of this section and who is not in the custody of the state:

(1) Residing in the state, with or without a fixed address; or

(2) The state of residency of the parent or caretaker, in accordance with 42 CFR.435.403(h)(1), with whom the individual resides;

c. An institutionalized child who is not a ward of the state if the state is the state of residence of the child's custodial parent or caretaker at the time of placement;

d. A child who is in the custody of the state regardless of where the child lives; or

e. A child physically located in the state when there is a dispute with one or more states as to the child's actual state of residence.

3. FAMIS eligibility is open to:

a. United States citizens;

b. United States nationals;

c. Qualified noncitizens as defined in § 431 of the Personal Responsibility and Work Opportunity Reconciliation Act (PRWORA) (8 USC § 1641) or whose eligibility is required by § 402(b) of PRWORA (8 USC § 1612(b)) and is not prohibited by § 403 of PRWORA (8 USC § 1613);

d. Individuals who have declared themselves to be citizens or nationals of the United States or an individual having satisfactory immigration status, during a reasonable opportunity period pending verification of their citizenship, nationality, or satisfactory immigration status consistent with requirements of §§ 1903(x), 1137(d), and 1902(ee) of the Social Security Act and 42 CFR 435.407, 42 CFR 407, 42 CFR 435.956, and 42 CFR 457.380.

(1) The reasonable opportunity period begins on and extends 90 calendar days from the date the notice of reasonable opportunity is received by the individual. "Notice of reasonable opportunity" means the written notice that is sent to the applicant to inform the applicant that the applicant must provide verification of citizenship and identity within 90 calendar days.

(2) An extension of the reasonable opportunity period is allowed if the individual is making a good faith effort to resolve any inconsistencies or obtain any necessary documentation, or the agency determining eligibility needs more time to complete the verification process.

(3) The agency will provide benefits to otherwise eligible individuals during the reasonable opportunity period;

e. Lawfully residing in the United States, as provided in § 2107(e)(1)(J) of the Social Security Act (§ 214 of CHIPRA 2009, P.L. 111-3). An individual is considered to be lawfully residing in the United States if the person is:

(1) A qualified noncitizen as defined in 8 USC § 1641(b) and (c);

(2) A noncitizen in a valid nonimmigrant status as defined in 8 USC § 1101(a)(15) or otherwise under the immigration laws (as defined in 8 USC § 1101 (a)(17));

(3) A noncitizen who has been paroled into the United States in accordance with 8 USC § 1182(d)(5) for less than one year, except for an individual paroled for prosecution, for deferred inspection, or pending removal proceedings;

(4) A noncitizen who belongs to one of the following classes:

(a) Granted temporary resident status in accordance with 8 USC § 1160 or 1255a, respectively;

(b) Granted temporary protected status (TPS) in accordance with 8 USC § 1254a and individuals with pending applications for TPS who have been granted employment authorization;

(c) Granted employment authorization under 8 CFR § 274a.12(c);

(d) Family unity beneficiaries in accordance with § 301 of P.L. 101-649, as amended;

(e) Under deferred enforced departure in accordance with a decision made by the President;

(f) Granted deferred action status;

(g) Granted an administrative stay of removal under 8 CFR 241; or

(h) Beneficiary of approved visa petition who has a pending application for adjustment of status;

(5) Is an individual with a pending application for asylum under 8 USC § 1158, for withholding of removal under 8 USC § 1231, or under the Convention Against Torture who:

(a) Has been granted employment authorization; or

(b) Is younger than 14 years of age and has had an application pending for at least 180 calendar days;

(6) Has been granted withholding of removal under the Convention Against Torture;

(7) Is a child who has a pending application for Special Immigrant Juvenile Status as described in 8 USC § 1101(a)(27)(J);

(8) Is lawfully present in American Samoa under the immigration laws of American Samoa; or

(9) Is a victim of severe trafficking in persons, in accordance with the Victims of Trafficking and Violence Protection Act of 2000, P.L. 106-386, as amended (22 USC § 7105(b)).

f. An individual with deferred action under the Department of Homeland Security's deferred action for the childhood arrivals process, as described in the Secretary of Homeland Security's June 15, 2012, memorandum, shall not be considered to be lawfully present with respect to any of the categories in subdivision E 3 e of this section.

4. Eligible individuals shall be uninsured, that is, not have creditable health insurance coverage. "Creditable health insurance coverage" means coverage that meets the definition of 42 CFR 457.10.

a. Individuals eligible for FAMIS shall not be found eligible or potentially eligible for Medicaid under policies of the State Plan determined through the screening process described at 42 CFR 457.350.

b. Any child covered under a group health plan or under health insurance coverage, as defined in § 2791 of the Public Health Services Act (42 USC § 300gg-91(a) and (b)(1)), shall not be eligible for FAMIS.

(1) FAMIS shall not be a substitution for private insurance.

(2) Only uninsured children shall be eligible for FAMIS. A child is not considered to be insured if the health insurance plan covering the child does not have a network of providers in the area where the child resides. Each application for child health insurance shall include an inquiry about health insurance. Each redetermination of eligibility shall also document inquiry about current health insurance.

(3) Health insurance does not include Medicare, Medicaid, FAMIS, or insurance for which DMAS paid premiums under Title XIX through the Health Insurance Premium Payment Program or under Title XXI through the state children's health insurance program premium assistance program known as FAMIS Select.

5. Residents of an institution. Eligible individuals may not be an inpatient in an institution for mental diseases or an inmate in a public institution that is not a medical facility at the time of the initial eligibility determination or redetermination.

6. Social Security Number.

a. All eligible individuals shall furnish their Social Security Numbers (SSNs), with the following exceptions: (i) individuals refusing to obtain a SSN because of well-established religious objections, (ii) individuals who are not eligible for a SSN, or (iii) individuals who are issued a SSN only for a valid nonwork purpose.

b. DMAS or its designee shall:

(1) Assist individuals who are required to provide their SSN to apply for or obtain an SSN from the Social Security Administration if the individuals do not have or forgot their SSNs;

(2) Inform individuals required to provide their SSNs (i) by what statutory authority the number is required to be provided; and (ii) how the Commonwealth will use the SSN;

(3) Verify each SSN furnished by applicants or beneficiaries with the Social Security Administration; and

(4) Not deny or delay services to an otherwise eligible applicant pending issuance or verification of the individual's SSN by the Social Security Administration.

c. The utilization of the SSN is consistent with §§ 205 and 1137 of the Social Security Act and the Privacy Act of 1974.

d. DMAS requests nonapplicant household members to voluntarily provide their SSNs. When requesting an SSN for nonapplicant household members, DMAS (i) informs the nonapplicant that this information is voluntary and provides information regarding how the SSN will be used and (ii) uses the SSN for determination of eligibility for Children's Health Insurance Program (CHIP) or other insurance affordability programs or for a purpose directly connected with the administration of the state plan.

F. Financial eligibility.

1. Screening. All applications shall have a Medicaid income eligibility screen completed. Children determined to be ineligible for Medicaid due to excess income will have their eligibility for FAMIS determined.

2. Standards.

a. The Commonwealth shall apply modified adjusted gross income (MAGI) methodologies for all separate CHIP covered groups, consistent with 42 CFR 457.315 and 435.603(b) through (i). FAMIS shall be available for targeted low-income children. Income standards shall be applied statewide. Children from birth to age 19 years who have income above the Medicaid-eligible limit at or below 200% of the federal poverty level, with a 5% income disregard, shall be income eligible to participate in FAMIS.

b. In determining family size for the eligibility determination of other individuals in the household that includes a pregnant woman, the pregnant woman is counted just as herself.

c. Financial eligibility is determined consistent with the following provisions:

(1) For new applicants, financial eligibility is based on the monthly income and family size.

(2) When determining eligibility for current beneficiaries, financial eligibility is based on current monthly household income and family size.

(3) In determining current household income, the agency will use reasonable methods to account for current income and reasonable prediction of changes in future income or family size.

d. Unless an exception exists, as provided at 42 CFR 457.315 and 42 CFR 435.603(d)(2) through (d)(4), household income is the sum of the MAGI-based income for every person counted in the individual's MAGI household.

3. Spenddown. The Commonwealth shall not apply a spenddown process for FAMIS where household income exceeds the income eligibility limit for FAMIS.

G. Eligibility of newborns.

1. If a child otherwise eligible for FAMIS is born within the three months prior to the month in which a signed application is received, the eligibility for coverage is effective retroactive to the child's date of birth if the child would have met all eligibility criteria during that time.

2. A child born to a targeted low-income pregnant woman is deemed to have applied for and be eligible for FAMIS or Medicaid until the child turns age one year in accordance with § 2112 of the Social Security Act. "Targeted low-income pregnant woman" means an uninsured pregnant woman whose household income is within the Medicaid or FAMIS MOMS eligibility standards established by the Commonwealth.

a. The child is deemed to have applied for and been found eligible for FAMIS or Medicaid, as appropriate, as of the date of the child's birth and remains eligible without regard to changes in circumstances until the child's first birthday.

b. DMAS shall cover as a deemed newborn a child born to a mother who is covered under Medicaid or CHIP through the authority of the state's § 1115 demonstration on the date of the newborn's birth.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 21, eff. August 1, 2003; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006; Volume 23, Issue 7, eff. January 10, 2007; Volume 26, Issue 6, eff. January 1, 2010; Volume 26, Issue 12, eff. March 17, 2010; Volume 27, Issue 7, eff. January 5, 2011; Volume 29, Issue 21, eff. July 17, 2013; Volume 30, Issue 20, eff. July 3, 2014; Volume 32, Issue 20, eff. June 29, 2016; Volume 35, Issue 20, eff. June 26, 2019.

12VAC30-141-110 Duration of eligibility and renewal

A. The effective date of FAMIS eligibility shall be the date of birth for a newborn deemed eligible under 12VAC30-141-100 G. For all other children, the effective date of FAMIS eligibility shall be the first day of the month in which a signed completed application was received by either the LDSS or CPU if the applicant met all eligibility requirements in that month. In no case shall a child's eligibility be effective earlier than the date of the child's birth.

B. Eligibility for FAMIS will continue for 12 months so long as the child remains a resident of Virginia and the child's countable income does not exceed 200% of the federal poverty level. A child born to a mother who was enrolled in FAMIS, under either the Title XXI Plan or a related waiver (such as FAMIS MOMS), on the date of the child's birth shall remain eligible for one year regardless of income unless otherwise found to be eligible for Medicaid. A change in eligibility will be effective the first of the month following expiration of a 10-calendar-day advance notice. Eligibility based on all eligibility criteria listed in 12VAC30-141-100 D will be redetermined no less often than annually.

C. Renewal of coverage.

1. Renewal of coverage for individuals whose financial eligibility is based on the applicable modified adjusted gross income (MAGI) standard are performed as follows, consistent with 42 CFR 457.343:

a. Renewal of coverage is completed once every 12 months, and

b. Without requiring information from the individual if able to do so based on an ex parte review of reliable information contained in the individual's account or other more current information available to the agency.

2. If the agency cannot determine eligibility solely on the basis of the ex parte review or otherwise needs additional information to complete the redetermination, the individual is provided with a renewal form that is prepopulated with information contained in the individual's case. The individual shall be allowed 30 calendar days to return the renewal form and the necessary verifications.

If the individual's coverage is canceled because the renewal was not completed (either electronically, by phone, or on paper) or because verifications needed to complete the renewal were not returned, the individual has 90 calendar days after the coverage is canceled to provide the information necessary to complete the renewal without having to file a new application. This 90-calendar-day period is called the reconsideration period. If all necessary information is provided during the reconsideration period and the individual found eligible, enrollment will be restored without any lapse in coverage.

History

• Statutory Authority: § of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 21, eff. August 1, 2003; amended, Virginia Register Volume 26, Issue 12, eff. March 17, 2010; Volume 27, Issue 7, eff. January 5, 2011; Volume 35, Issue 20, eff. June 26, 2019.

12VAC30-141-120 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 19, Issue 21, eff. August 1, 2003; amended, Virginia Register Volume 23, Issue 7, eff. January 10, 2007; Volume 25, Issue 14, eff. April 15, 2009; repealed, Virginia Register Volume 35, Issue 20, eff. June 26, 2019.

12VAC30-141-130 Nondiscriminatory provisions

FAMIS shall be conducted in compliance with all civil rights requirements. FAMIS shall not:

1. Discriminate during the eligibility determination process on the basis of diagnosis;

2. Cover children of higher income without first covering children with a lower family income within a defined group of covered targeted low-income children; and

3. Deny eligibility based on a child having a preexisting medical condition.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 21, eff. August 1, 2003.

12VAC30-141-140 No entitlement

In accordance with § 2102(b)(4) of the Social Security Act and § 32.1-353 of the Code of Virginia, FAMIS shall not create any entitlement for, right to, or interest in payment of medical services on the part of any medically indigent child or any right or entitlement to participation.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 21, eff. August 1, 2003.

12VAC30-141-150 Application requirements

A. Availability of program information. DMAS or its designee shall furnish the following information in written form and orally as appropriate to all applicants and to other individuals who request it:

1. The eligibility requirements;

2. Summary of covered benefits;

3. Copayment amounts required; and

4. The rights and responsibilities of applicants and enrollees.

B. Opportunity to apply. DMAS or its designee must afford an individual, wishing to do so, the opportunity to apply. Applicants may file an application by mail, by fax, by phone, via the internet, or in person at local departments of social services. Face-to-face interviews for the program are not required. Eligibility determinations for FAMIS shall occur at either local departments of social services, DMAS, or the CPU.

C. Application. DMAS or its designee shall require an application from the applicant if the applicant is at least 18 years of age or older, or from a parent, adult relative caretaker, guardian, legal custodian, or authorized representative if the applicant is younger than 18 years of age or the applicant is incapacitated. "Incapacitated" means a person who, pursuant to an order of a court of competent jurisdiction, has been found to be incapable of receiving and evaluating information effectively or responding to people, events, or environments to such an extent that the individual lacks the capacity to (i) meet the essential requirements of his health, care, safety, or therapeutic needs without the assistance or protection of a guardian, or (ii) manage property or financial affairs or provide for his support or for the support of his legal dependents without the assistance or protection of a conservator.

1. DMAS employs a single, streamlined application developed by the state and approved by the Secretary of the Department of Health and Human Services in accordance with § 1413(b)(I)(B) of the Affordable Care Act.

2. DMAS may employ an alternative application used to apply for multiple human service programs approved by the Secretary of the Department of Health and Human Services, provided that the agency makes readily available the single or alternative application used only for insurance affordability programs to individuals seeking assistance only through such programs.

D. Right to apply. An individual who is 18 years of age shall not be refused the right to complete an application for himself and shall not be discouraged from asking for assistance for himself under any circumstances.

E. Applicant's signature. The applicant must sign state-approved application forms submitted, even if another person fills out the form, unless the application is filed and signed by the applicant's parent, adult relative caretaker, legal guardian or conservator, attorney-in-fact or authorized representative.

F. The authorized representative for an individual 18 years of age or older shall be those individuals as set forth in 12VAC30-110-1380.

G. The authorized representative for children younger than 18 years of age shall be those individuals as set forth in 12VAC30-110-1390.

H. Persons prohibited from signing an application. An employee of, or an entity hired by, a medical service provider who stands to obtain FAMIS payments shall not sign an application for health insurance on behalf of an individual who cannot designate an authorized representative.

I. Assistance with application. DMAS or its designee shall allow an individual of the applicant's choice to assist and represent the applicant in the application process, a renewal process, or both.

J. Timely determination of eligibility. The time processing standards for determining eligibility begin with the date an application is submitted online, by telephone, by fax, or received in hard copy either at a LDSS or the CPU. An application for health insurance shall have an eligibility determination performed within the established federal case processing time standards.

K. Notice of the decision concerning eligibility. The determining agency shall send each applicant a written notice of the agency's or designee's decision on the applicant's application, and if approved, the applicant's obligations under the program. If eligibility for both FAMIS and Medicaid is denied, notice must be given concerning the reasons for the action and an explanation of the applicant's right to request a review of the adverse actions, as described in 12VAC30-141-50.

L. Case documentation. The determining agency shall include in each applicant's record all necessary facts to support the decision on the applicant's application and must dispose of each application by a finding of eligibility or ineligibility, unless (i) there is an entry in the case record that the applicant voluntarily withdrew the application and that the agency or its designee sent a notice confirming the applicant's decision; or (ii) there is a supporting entry in the case record that the applicant cannot be located.

M. Case maintenance. All cases approved for FAMIS shall be maintained at local departments of social services or another entity designated by DMAS. The determining agency will be responsible for providing newly enrolled recipients with program information, benefits available, how to secure services under the program, a FAMIS handbook, and for processing changes in eligibility and annual renewals within established timeframes. DMAS outreach resources may also provide information or assistance to the enrollee.

N. Renewal of eligibility. DMAS, LDSS, or the CPU shall redetermine the eligibility of enrollees with respect to circumstances that may change at least every 12 months. During the 12-month period of coverage, enrollees must make timely and accurate reports if an enrollee no longer resides in the Commonwealth of Virginia or when changes in income exceed 200% of the federal poverty level plus a 5.0% income disregard. The agency responsible for managing the case shall promptly redetermine eligibility when it receives information about changes in a FAMIS enrollee's circumstances that may affect eligibility. DMAS or its designee may assist with documenting changes reported by the enrollee.

O. Notice of decision concerning eligibility. The agency responsible for managing the case shall give enrollees timely notice of proposed action to terminate their eligibility under FAMIS. The notice must meet the requirements of 42 CFR 457.1180.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC§ 1396 seq.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 21, eff. August 1, 2003; amended, Virginia Register Volume 23, Issue 7, eff. January 10, 2007; Volume 35, Issue 20, eff. June 26, 2019.

Part IV Cost Sharing

12VAC30-141-160 Copayments for families not participating in FAMIS Select

A. Copayments shall apply to all enrollees in an MCHIP.

B. These cost-sharing provisions shall be implemented with the following restrictions:

1. Total cost sharing for each 12-month eligibility period shall be limited to (i) for families with incomes equal to or less than 150% of federal poverty level (FPL), the lesser of (a) $180 and (b) 2.5% of the family's income for the year (or 12-month eligibility period); and (ii) for families with incomes greater than 150% of FPL, the lesser of $350 and 5.0% of the family's income for the year (or 12-month eligibility period).

2. DMAS or its designee shall ensure that the annual aggregate cost sharing for all FAMIS enrollees in a family does not exceed the aforementioned caps.

3. Families will be required to submit documentation to DMAS or its designee showing that their maximum copayment amounts are met for the year.

4. Once the cap is met, DMAS or its designee will issue a new eligibility card excluding such families from paying additional copays for the 12-month enrollment period.

C. Exceptions to the above cost-sharing provisions:

1. Copayments shall not be required for well child, well baby, and pregnancy-related services. This shall include:

a. All healthy newborn inpatient physician visits, including routine screening (inpatient or outpatient);

b. Routine physical examinations, laboratory tests, immunizations, and related office visits;

c. Routine preventive and diagnostic dental services (i.e., oral examinations, prophylaxis and topical fluoride applications, sealants, and x-rays);

d. Services to pregnant females related to the pregnancy; and

e. Other preventive services as defined by the department.

2. Enrollees are not held liable for any additional costs, beyond the standard copayment amount, for emergency services furnished outside of the individual's managed care network. Only one copayment charge will be imposed for a single office visit.

3. No cost sharing will be charged to American Indians and Alaska Natives.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC 1396 seq.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 21, eff. August 1, 2003; amended, Virginia Register Volume 22, Issue 26, eff. October 4, 2006; Volume 26, Issue 12, eff. July 1, 2010; Errata, 26:13 2238 VA.R. March 1, 2010; amended, Virginia Register Volume 35, Issue 20, eff. June 26, 2019.

12VAC30-141-170 (Repealed.)

Historical Notes

Derived from Virginia Register Volume 19, Issue 21, eff. August 1, 2003; repealed, Virginia Register Volume 22, Issue 26, eff. October 4, 2006.

12VAC30-141-175 FAMIS Select

A. Enrollees in FAMIS may, but shall not be required to, enroll in a private or employer-sponsored health plan if DMAS or its designee determines that such enrollment is cost effective, as defined in this section.

B. Eligibility determination. FAMIS children may elect to receive coverage under a health plan purchased privately or through an employer and DMAS may elect to provide coverage by paying all or a portion of the premium if all of the following conditions are met:

1. The children are determined to be eligible for FAMIS;

2. The cost of coverage for the child under FAMIS Select is equal to or less than the Commonwealth's cost of obtaining coverage under FAMIS only for the eligible targeted low-income children involved. The cost-effectiveness determination methodology is described in subsection E of this section;

3. The policyholder agrees to assign rights to benefits under the private or employer-sponsored health plan to DMAS to assist the Commonwealth in pursuing these third-party payments for childhood immunizations. When a child is provided coverage under a private or employer-sponsored health plan, that plan becomes the payer for all other services covered under that plan; and

4. The policyholder is not under a court order to provide medical support for the applicant child.

C. DMAS will continually verify the child's or coverage under the private or employer-sponsored health plan and will redetermine the eligibility of the child for the FAMIS Select component when it receives information concerning an applicant's or enrollee's circumstances that may affect eligibility.

D. Application requirements.

1. DMAS shall furnish the following information in written form and orally, as appropriate, to the families of FAMIS children who have indicated an interest in FAMIS Select:

a. The eligibility requirements for FAMIS Select;

b. A description of how the program operates, the amount of premium assistance available, and how children can move from FAMIS Select into FAMIS if requested;

c. A summary of the covered benefits and cost-sharing requirements available through FAMIS;

d. A guide to help families make an informed choice by comparing the FAMIS plan to their private or employer-sponsored health plan. Such guide shall include a notice to the effect that children covered by FAMIS Select will not receive FAMIS-covered services, but only those health services covered by their private or employer-sponsored health plan, and that the FAMIS Select enrollee shall be responsible for any and all costs associated with their chosen health plan;

e. Information on coverage for childhood immunizations through FAMIS; and

f. The rights and responsibilities of applicants and enrollees.

2. DMAS will provide interested families with applications for FAMIS Select.

3. An electronic or written application for the FAMIS Select component shall be required from interested families.

4. DMAS shall determine eligibility for the FAMIS Select component promptly, within 45 calendar days from the date of receiving an application that contains all information and verifications necessary to determine eligibility, except in unusual circumstances beyond the agency's control. Actual enrollment into the FAMIS Select component may not occur for extended periods of time, depending on the ability of the family to enroll in the employer's plan.

5. Incomplete FAMIS Select applications shall be held for a period of 30 calendar days to enable applicants to provide outstanding information needed for a FAMIS Select eligibility determination. Any applicant who, within 30 calendar days of the receipt of the initial application, fails to provide information or verifications necessary to determine FAMIS Select eligibility shall have his application denied.

6. DMAS must send each applicant a written notice of the agency's decision on his application for FAMIS Select and, if approved, his obligations under the program. If eligibility is denied, notice will be given concerning the reasons for the denial.

E. Cost effectiveness. DMAS may elect to provide coverage to FAMIS children by paying all or a portion of the family's private or employer-sponsored health insurance premium if the cost of such premium assistance under FAMIS Select is equal to or less than the Commonwealth's cost of obtaining coverage under FAMIS only for the eligible, targeted, low-income child involved. Providing premium assistance for the FAMIS-eligible children may result in the coverage of an adult or other relative or dependent; however, this coverage shall be solely incidental to covering the FAMIS child.

1. To ensure that the FAMIS Select program remains cost effective, DMAS will establish a fixed premium assistance amount per child that will be paid to a family choosing to enroll their FAMIS-eligible child in FAMIS Select. The fixed premium assistance amount will be determined annually by:

a. Determining the cost of covering a child under FAMIS. The cost will be determined by using the capitated payment rate paid to MCHIPs, or an average cost amount developed by DMAS;

b. Determining the administrative costs associated with the FAMIS Select program; and

c. Establishing a fixed premium assistance amount that includes administrative costs and is less than or equal to the cost of covering the FAMIS child under FAMIS.

DMAS will ensure that the total of the fixed premium assistance amounts for all the FAMIS-eligible children per family do not exceed the total cost of the family's health insurance premium payment for the private or employer-sponsored health plan. If the total fixed premium assistance amounts do exceed the family's premium payment, then the family premium assistance will be reduced by an amount necessary to ensure the premium assistance payment is less than or equal to the family's premium payment.

F. Enrollment and disenrollment.

1. FAMIS children applying for FAMIS Select will receive coverage under FAMIS until their eligibility for coverage under the FAMIS Select component is established and until they are able to enroll in the private or employer-sponsored health plan.

2. The timing and procedures employed to transfer FAMIS children's coverage to the FAMIS Select component will be coordinated between DMAS and the agency managing the case to ensure continuation of coverage.

3. Participation by families in the FAMIS Select component shall be voluntary. Families may disenroll their child from the FAMIS Select component as long as the proper timing and procedures established by DMAS are followed to ensure continued health coverage.

G. Premium assistance. When a child is determined eligible for coverage under the FAMIS Select component, premium assistance payments shall become effective the month in which the FAMIS child is enrolled in the employer's plan. Payment of premium assistance shall end:

1. On the last day of the month in which FAMIS eligibility ends;

2. The last day of the month in which the child loses eligibility for coverage under the private or employer-sponsored health plan;

3. The last day of the month in which the family notifies DMAS that it wishes to disenroll its child from the FAMIS Select component; or

4. On the next business day following a request by the family to immediately transfer the child from FAMIS Select into the FAMIS program. The request must include notification that the child's private or employer-sponsored health plan has been terminated as of the date of transfer and an agreement by the family to return to DMAS the premium assistance payment prorated for that portion of the month in which the child was not enrolled in the private or employer-sponsored health plan.

H. Supplemental health benefits coverage will be provided to ensure that FAMIS children enrolled in the FAMIS Select component receive all childhood immunizations available under the FAMIS benefits. FAMIS children can obtain these supplemental benefits through Medicaid providers.

I. Cost sharing. FAMIS Select families will be responsible for all copayments, deductibles, coinsurance, fees, or other cost-sharing requirements of the private or employer-sponsored health plan in which they enroll their children. There is no Title XXI family cost-sharing cap applied to families with children enrolled in FAMIS Select.

There is no copayment required for the supplemental immunization benefits provided through FAMIS.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 22, Issue 26, eff. October 4, 2006; amended, Virginia Register Volume 35, Issue 20, eff. June 26, 2019.

12VAC30-141-180 Liability for excess benefits; liability for excess benefits or payments obtained without intent; recovery of FAMIS payments

A. Any person who, without the intent to violate this section, obtains benefits or payments under FAMIS to which he is not entitled shall be liable for any excess benefits or payments received. If the enrollee knew or reasonably should have known that he was not entitled to the excess benefits, he may also be liable for interest on the amount of the excess benefits or payments at the judgment rate as defined in § 6.1-330.54 of the Code of Virginia from the date upon which excess benefits or payments to the date on which repayment is made to the Commonwealth. No person shall be liable for payment of interest, however, when excess benefits or payments were obtained as a result of errors made solely by DMAS or its designee.

B. Any payment erroneously made on behalf of a FAMIS enrollee or former enrollee may be recovered by DMAS from the enrollee or the enrollee's income, assets, or estate unless state or federal law or regulation otherwise exempts such property.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 21, eff. August 1, 2003; amended, Virginia Register Volume 23, Issue 7, eff. January 10, 2007.

12VAC30-141-190 [Reserved]

Historical Notes

Derived from Virginia Register Volume 19, Issue 21, eff. August 1, 2003.

Part V Benefits and Reimbursement

12VAC30-141-200 Benefit packages

The Commonwealth's Title XXI State Plan utilizes two benefit packages within FAMIS as set forth in the FAMIS State Plan, as may be amended from time to time. One package is a modified Medicaid look-alike component offered through a fee-for-service program; the other package is modeled after the state employee health plan and delivered by contracted MCHIPs.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 21, eff. August 1, 2003; amended, Virginia Register Volume 22, Issue 23, eff. August 23, 2006; Volume 22, Issue 26, eff. October 4, 2006; Volume 30, Issue 12, eff. March 28, 2014.

12VAC30-141-210 [Reserved]

Historical Notes

Derived from Virginia Register Volume 19, Issue 21, eff. August 1, 2003.

12VAC30-141-500 Benefits reimbursement

A. Reimbursement for the services covered under FAMIS fee-for-service and MCHIPs shall be as specified in this section.

B. Reimbursement for physician services, surgical services, clinic services, prescription drugs, laboratory and radiological services, outpatient mental health services, early intervention services, emergency services, home health services, immunizations, mammograms, medical transportation, organ transplants, skilled nursing services, well baby and well child care, vision services, durable medical equipment, disposable medical supplies, dental services, case management services, physical therapy, occupational therapy, or speech-language therapy services, hospice services, school-based health services, behavioral therapy services including applied behavior analysis, and certain community-based mental health services shall be based on the Title XIX rates.

C. Reimbursement to MCHIPs shall be determined on the basis of the estimated cost of providing the MCHIP benefit package and services to an actuarially equivalent population. MCHIP rates will be determined annually and published 30 days prior to the effective date.

D. Exceptions.

1. Prior authorization is required after five visits in a fiscal year for physical therapy, occupational therapy, and speech-language therapy provided by home health providers and outpatient rehabilitation facilities and for home health skilled nursing visits. Prior authorization is required for the following nonemergency outpatient procedures: Magnetic Resonance Imaging, including Magnetic Resonance Angiography (MRA), Computerized Axial Tomography (CAT) scans, including Computed Tomography Angiography (CTA), or Positron Emission Tomography (PET) scans performed for the purpose of diagnosing a disease process or physical injury. Prior authorization for dental services will be based on the Title XIX prior authorization requirements for dental services.

2. Reimbursement for inpatient hospital services will be based on the Title XIX rates in effect for each hospital. Reimbursement shall not include payments for disproportionate share or graduate medical education payments made to hospitals. Payments made shall be final and there shall be no retrospective cost settlements.

3. Reimbursement for outpatient hospital services shall be based on the Title XIX rates in effect for each hospital. Payments made will be final and there will be no retrospective cost settlements.

4. Reimbursement for inpatient mental health services other than by free standing psychiatric hospitals will be based on the Title XIX rates in effect for each hospital. Reimbursement will not include payments for disproportionate share or graduate medical education payments made to hospitals. Payments made will be final and there will be no retrospective cost settlements.

5. Reimbursement for outpatient rehabilitation services will be based on the Title XIX rates in effect for each rehabilitation agency. Payments made will be final and there will be no retrospective cost settlements.

6. Reimbursement for outpatient substance abuse treatment services will be based on rates determined by DMAS for children ages six through 18 years. Payments made will be final and there will be no retrospective cost settlements.

7. Reimbursement for prescription drugs will be based on the Title XIX rates in effect. Reimbursements for Title XXI do not receive drug rebates as under Title XIX.

8. Reimbursement for covered prescription drugs for noninstitutionalized FAMIS recipients receiving the fee-for-service benefits will be subject to review and prior authorization when their current number of prescriptions exceeds nine unique prescriptions within 180 calendar days, and as may be further defined by the agency's guidance documents for pharmacy utilization review and the prior authorization program. The prior authorization process shall be applied consistent with the process set forth in 12VAC30-50-210 A 7.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 21, eff. August 1, 2003; amended, Virginia Register Volume 21, Issue 19, eff. June 29, 2005; Volume 22, Issue 16, eff. July 3, 2006; Volume 22, Issue 23, eff. August 23, 2006; Volume 30, Issue 12, eff. March 28, 2014; Volume 32, Issue 26, eff. September 21, 2016; Volume 35, Issue 20, eff. June 26, 2019.

12VAC30-141-510 [Reserved]

Historical Notes

Derived from Virginia Register Volume 19, Issue 21, eff. August 1, 2003.

Part VI Quality Assurance and Utilization Control

12VAC30-141-560 Quality assurance

A. Each provider entity shall meet requirements for the following either as administered by DMAS or as determined by contract with DMAS: access to well-child health services, immunizations, provider network adequacy, a system to provide enrollees urgent care and emergency services, systems for complaints, grievances and reviews, a data management system and quality improvement programs and activities.

B. Each MCHIP shall meet requirements determined by the contract for the internal and external quality monitoring and reporting of access to services, timeliness of services, and appropriateness of services, as determined by DMAS.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 21, eff. August 1, 2003.

12VAC30-141-570 Utilization control

A. Each MCHIP shall implement a utilization review system as determined by contract with DMAS, or administered by DMAS.

B. For the fee-for-service program, DMAS shall use the utilization controls already established and operational in the State Plan for Medical Assistance.

C. DMAS may collect and review comprehensive data to monitor utilization after receipt of services.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 21, eff. August 1, 2003; amended, Virginia Register Volume 30, Issue 12, eff. March 28, 2014.

12VAC30-141-580 [Reserved]

Historical Notes

Derived from Virginia Register Volume 19, Issue 21, eff. August 1, 2003.

12VAC30-141-600 Recipient audit unit

A. Pursuant to Chapter 9 (§ 32.1-310 et seq.) of Title 32.1 of the Code of Virginia, the recipient audit unit shall investigate allegations of acts of fraud or abuse, committed by persons enrolled in the FAMIS program or the parent, adult caretaker relative, guardian, legal custodian or authorized representative on behalf of a person or persons enrolled in the FAMIS program, which result in misspent funds.

B. Any FAMIS enrollee, parent, adult caretaker relative, guardian, legal custodian or authorized representative of a FAMIS enrollee who, on the behalf of others, attempts to obtain benefits to which the enrollee is not entitled by means of a willful false statement or by willful misrepresentation, or by willful concealment of any material facts, shall be liable for repayment of any excess benefits received and the appropriate interest charges.

C. Upon the determination that fraud or abuse has been committed, criminal or civil action may be initiated.

D. When determining the amount of misspent funds to be recovered, capitation fees shall be included for FAMIS enrollees who received benefits through managed care.

E. Access to FAMIS enrollees' records by authorized DMAS representatives shall be permitted upon request.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 21, eff. August 1, 2003.

12VAC30-141-610 [Reserved]

Historical Notes

Derived from Virginia Register Volume 19, Issue 21, eff. August 1, 2003.

12VAC30-141-650 Provider review

A. The provider review unit shall be responsible for reviewing enrolled FAMIS providers to identify potential inappropriate utilization of services and potential billing errors.

B. Providers agree to keep such records as DMAS determines necessary. The providers shall furnish DMAS, upon request, information regarding payments claimed for providing services under the State Plan for Title XXI.

C. Access to records and facilities by authorized DMAS representatives shall be permitted upon request.

D. Providers shall be required to refund payments made by DMAS if they are found to have billed DMAS contrary to policy, failed to maintain records or adequate documentation to support their claims, or billed for medically unnecessary services.

E. A review of adverse actions concerning provider reimbursement shall be heard in accordance with the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) and the Virginia Administrative Code, 12VAC30-10-1000 and 12VAC30-20-500 through 12VAC30-20-560.

F. MCHIPs shall be responsible for keeping provider profile and utilization mechanisms to monitor provider activities. MCHIPs shall be reviewed by DMAS.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 21, eff. August 1, 2003; amended, Virginia Register Volume 23, Issue 7, eff. January 10, 2007.

12VAC30-141-660 Assignment to managed care

A. Except for children enrolled in the Virginia Birth-Related Neurological Injury Compensation Program established pursuant to Chapter 50 (§ 38.2-5000 et seq.) of Title 38.2 of the Code of Virginia, all eligible enrollees shall be assigned in managed care through the department or CPU. FAMIS individuals, during the preassignment period to an MCHIP, shall receive Title XXI benefits via fee-for-service utilizing a FAMIS card issued by DMAS. After assignment to an MCHIP, benefits and the delivery of benefits shall be administered specific to the managed care program in which the individual is enrolled. DMAS shall contract with MCHIPs to deliver health care services for infants born to mothers enrolled in FAMIS for the month of birth plus two additional months regardless of the status of the newborn's application for FAMIS. If federal funds are not available for those months of coverage, DMAS shall use state funding only.

1. MCHIPs shall be offered to enrollees in all areas.

2. All enrollees shall be assigned to the contracted MCHIPs.

3. Applicants for FAMIS may choose an MCHIP at the time of application. If a choice is not made at application, enrollees shall be assigned through a random system algorithm; provided however, all children within the same family shall be assigned to the same MCHIP.

4. All children enrolled in the Virginia Birth-Related Neurological Injury Compensation Program shall be assigned to the fee-for-service component.

5. Enrolled individuals will receive a letter indicating that they may select one of the contracted MCHIPs that serve such area. Enrollees who do not select an MCHIP as described above, shall be assigned to an MCHIP as described in subdivision 3 of this subsection.

6. Individuals assigned to an MCHIP who lose and then regain eligibility for FAMIS within 60 days will be reassigned to their previous MCHIP.

B. Following their initial assignment to an MCHIP, those enrollees shall be restricted to that MCHIP until their next annual eligibility redetermination, unless appropriately disenrolled by the department.

1. During the first 90 calendar days of managed care assignment, an enrollee may request reassignment for any reason. Such reassignment shall be effective no later than the first day of the second month after the month in which the enrollee requests reassignment.

2. Enrollees may only request reassignment to another MCHIP serving that geographic area.

3. After the first 90 calendar days of the assignment period, the enrollee may only be reassigned from one MCHIP to another MCHIP upon determination by DMAS that good cause exists pursuant to subsection C of this section or for any reason at annual renewal.

C. Disenrollment for good cause, defined in 12VAC30-120-370, may be requested at any time.

1. After the first 90 calendar days of assignment in managed care, enrollees may request disenrollment from DMAS based on good cause. The request must cite the reasons why the enrollee wishes to be reassigned. The department shall establish procedures for good cause reassignment through written policy directives.

2. DMAS shall determine whether good cause exists for reassignment.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 19, Issue 21, eff. August 1, 2003; amended, Virginia Register Volume 22, Issue 8, eff. April 3, 2006; Volume 25, Issue 16, eff. May 13, 2009; Volume 25, Issue 25, September 16, 2009; Volume 30, Issue 12, eff. March 28, 2014; Volume 35, Issue 20, eff. June 26, 2019.

Part VII FAMIS MOMS

12VAC30-141-670 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Adverse action," consistent with 42 CFR 457.1130, means the denial of eligibility; failure to make a timely determination of eligibility; suspension or termination of enrollment, including disenrollment for failure to pay cost sharing; or delay, denial, reduction, suspension, or termination of health services, in whole or in part, including a determination about the type or level of services; and failure to approve, furnish, or provide payment for health services in a timely manner; provided, however, that determination of eligibility to participate in and termination of participation in the FAMIS Select program shall not constitute an adverse action.

"Adverse benefit determination," consistent with 42 CFR 438.400, means the denial or limited authorization of a requested service; the failure to take action or timely take action on a request for service; the reduction, suspension, or termination of a previously authorized service; denial in whole or in part of a payment for a service; failure to provide services within the timeframes required by the state; for a resident of a rural exception area with only one MCO, the denial of a enrollee's request to exercise the enrollee's right under 42 CFR 438.52(b)(2)(ii) to obtain services outside of the network; the denial of a enrollee's request to dispute a financial liability as provided in 42 CFR 438.400(b)(7); or the failure of an MCO to act within the timeframes provided in 42 CFR 438.408(b).

"Agency" means the same as defined in 12VAC30-141-10.

"Agent" means an individual designated in writing to act on behalf of a FAMIS MOMS Plan applicant or enrollee during the administrative review process.

"Appeal" means an enrollee's request for review of an adverse benefit determination by an MCO or an adverse action by the LDSS, CPU, or DMAS.

"Applicant" means a pregnant woman who has filed an application (or who has an application filed on her behalf) for health insurance and is awaiting a determination of eligibility. A pregnant woman is an applicant until her eligibility has been determined.

"Application for health insurance" means the single streamlined application for determining eligibility in public health insurance programs operated by the Commonwealth.

"Authorized representative" means a person who is authorized to conduct the personal or financial affairs for an individual who is 18 years of age or older.

"Central processing unit" or "CPU" means Cover Virginia, which is the same as defined in 12VAC30-141-10.

"Child" means an individual younger than 19 years of age.

"Conservator" means a person appointed by a court of competent jurisdiction to manage the estate and financial affairs of an incapacitated individual.

"Continuation of coverage" means ensuring an enrollee's benefits are continued until completion of the review process, with the condition that should the enrollee not prevail in the review process, the enrollee shall be liable for the repayment of all benefits received during the review process.

"Director" means the individual, or his designee, specified in § 32.1-324 of the Code of Virginia with all of the attendant duties and responsibilities to administer the State Plan for Medical Assistance and the State Plan for Title XXI.

"DMAS" or "department" means the Department of Medical Assistance Services.

"Enrollee" means a pregnant woman who has been determined eligible to participate in FAMIS MOMS and is enrolled in the FAMIS MOMS program.

"FAMIS" means the Family Access to Medical Insurance Security Plan.

"FAMIS MOMS" means the Title XXI program available to eligible pregnant women.

"Federal poverty level" or "FPL" means that income standard as published annually by the U.S. Department of Health and Human Services in the Federal Register.

"Fee-for-service" means the traditional Medicaid health care delivery and payment system in which physicians and other providers receive a payment for each unit of service they provide.

"Guardian" means a person appointed by a court of competent jurisdiction to be responsible for the affairs of an incapacitated individual, including responsibility for making decisions regarding the person's support, care, health, safety, habilitation, education, and therapeutic treatment, and, if not inconsistent with an order of commitment, residence.

"Incapacitated " means a person who, pursuant to an order of a court of competent jurisdiction, has been found to be incapable of receiving and evaluating information effectively or responding to people, events, or environments to such an extent that the individual lacks the capacity to (i) meet the essential requirements of her health, care, safety, or therapeutic needs without the assistance or protection of a guardian, or (ii) manage property or financial affairs or provide for her support or for the support of her legal dependents without the assistance or protection of a conservator.

"LDSS" or "local department" means the local department of social services.

"Managed care organization" or "MCO" means an organization that offers managed care health insurance plans (MCHIPs) as defined in § 32.1-137.1 of the Code of Virginia.

"Pregnant woman" means a woman of any age who is medically determined to be pregnant. The pregnant woman definition is met from the first day of the earliest month that the medical practitioner certifies as being a month in which the woman was pregnant, through the last day of the month in which the 60th day occurs, following the last day of the month in which her pregnancy ended, regardless of the reason the pregnancy ended.

"Provider" means the individual, facility, or other entity registered, licensed, or certified, as appropriate, and enrolled by an MCHIP or in fee-for-service to render services to FAMIS MOMS enrollees eligible for services.

"State fair hearing" means, consistent with 42 CFR 438.400, the process set forth in 42 CFR 431 Subpart E.

"Title XXI" means the federal State Children's Health Insurance Program as established by Subtitle J of the Balanced Budget Act of 1997.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 7, eff. January 10, 2007; amended, Virginia Register Volume 30, Issue 12, eff. March 28, 2014; Volume 35, Issue 20, eff. June 26, 2019.

12VAC30-141-680 Administration and general background

A. The state shall use funds provided under Title XXI for obtaining coverage that meets the requirements of Title XXI of the Social Security Act and any waiver of federal regulations approved by the Centers for Medicare and Medicaid Services.

B. The DMAS director will have the authority to contract with entities for the purposes of establishing a centralized processing site, determining eligibility, enrolling eligible pregnant women into health plans, performing outreach, data collection, reporting, and other services necessary for the administration of the FAMIS MOMS program.

C. Health care services under FAMIS MOMS shall be provided through MCHIPs and fee-for-service or through any other health care delivery system deemed appropriate by the Department of Medical Assistance Services.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 7, eff. January 10, 2007; amended, Virginia Register Volume 30, Issue 12, eff. March 28, 2014; Volume 35, Issue 20, eff. June 26, 2019.

12VAC30-141-690 Outreach and public participation

A. DMAS will work cooperatively with other state agencies and contractors to ensure that state and federal law and any applicable state and federal regulations are met.

B. DMAS shall develop a comprehensive marketing and outreach effort. The marketing and outreach efforts will be aimed at promoting FAMIS MOMS and Medicaid for pregnant women and increasing enrollment and may include contracting with a public relations firm, nonprofit agencies, and foundations, and coordination with other state agencies, coordination with the business community, and coordination with health care associations and providers.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 7, eff. January 10, 2007; amended, Virginia Register Volume 35, Issue 20, eff. June 26, 2019.

12VAC30-141-700 Appeal of adverse actions or adverse benefit determinations

A. Upon request, all FAMIS MOMS program applicants and enrollees shall have the right to a state fair hearing of an adverse action made by the local department of social services, CPU, or DMAS, or an internal appeal of an adverse benefit determination made by the MCO.

B. During the appeal of a suspension or termination of enrollment or a reduction, suspension, or termination of services, the enrollee shall have the right to continuation of coverage if the enrollee requests an internal appeal with the MCO or an appeal to DMAS prior to the effective date of the suspension or termination of enrollment or suspension, reduction, or termination of services.

C. An appeal of an adverse action made by the local department of social services, CPU, or DMAS shall be heard and decided by an agent of DMAS who has not been directly involved in the adverse action under appeal.

D. An internal appeal of an adverse benefit determination made by the MCO must be conducted by a person or agent of the MCO who has not been directly involved in the adverse benefit determination under appeal.

E. Pursuant to 42 CFR 438.402(c)(1)(B), after exhausting the MCO's internal appeals process, there shall be opportunity for the enrollee to request an external medical review by an independent external quality review organization. "External quality review organization" means the independent contractor assigned by DMAS to handle quality reviews and to conduct final review of MCHIP adverse actions for FAMIS MOMS. The review is optional and shall not be required before proceeding to a state fair hearing. The review shall not extend any of the timeframes for issuing a decision and shall not disrupt any continuation of coverage granted to the enrollee.

F. There will be no opportunity for appeal of an adverse action to the extent that such adverse action is based on a determination by the director that funding for FAMIS MOMS has been terminated or exhausted. There will be no opportunity for appeal if the sole basis for the decision is a provision in the State Plan or in a state or federal law requiring an automatic change in eligibility or enrollment or a change in coverage under the health benefits package that affects all applicants or enrollees or a group of applicants or enrollees without regard to their individual circumstances.

G. The burden of proof shall be assigned to the party who is attempting to make a change per 12VAC30-110-220 C.

H. At no time shall the failure of MCO, LDSS, CPU, or DMAS to meet the timeframes set in this chapter or set in the MCO or DMAS written appeal procedure constitute a basis for granting the applicant or enrollee the relief sought.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 7, eff. January 10, 2007; amended, Virginia Register Volume 35, Issue 20, eff. June 26, 2019; Volume 40, Issue 22, eff. August 1, 2024.

12VAC30-141-710 Notice of adverse action or adverse benefit determination

A. The LDSS, CPU, DMAS, or DMAS contractor shall send written notification to enrollees at least 10 calendar days prior to suspension or termination of enrollment.

B. DMAS or the MCO shall send written notification to enrollees at least 10 calendar days prior to reduction, suspension, or termination of a previously authorized health service.

C. The local department of social services, CPU, DMAS, or MCO shall send written notification to applicants and enrollees of all other adverse actions within 10 calendar days of the adverse action.

D. Notice shall include:

1. The determination the LDSS, CPU, DMAS, or MCO has made or intends to make;

2. The reasons for the determination, including the right of the enrollee to be provided upon request and free of charge reasonable access to and copies of all documents, records, and other information relevant to the determination;

3. An explanation of applicable rights to request an appeal of that determination. For adverse benefit determinations by an MCO, this shall include information on the MCO's internal appeals process and, after the internal appeals process is exhausted, a state fair hearing pursuant to 42 CFR 402(b) and 42 CFR 402(c);

4. The procedures for exercising these appeal rights;

5. The circumstances under which an appeal process can be expedited and how to request it; and

6. The circumstances under which enrollment or services may continue pending appeal, how to request benefits be continued, and the circumstances, consistent with state policy, under which the enrollee may be required to pay the costs of these services.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 7, eff. January 10, 2007; amended, Virginia Register Volume 35, Issue 20, eff. June 26, 2019.

12VAC30-141-720 Request for appeal

A. Requests for internal appeal of MCO adverse benefit determinations shall be submitted orally or in writing to the MCO. Unless the enrollee requests an expedited appeal, an oral appeal request must be followed by a written appeal request. The enrollee must exhaust the MCO's internal appeals process before appealing to DMAS.

B. If the MCO fails to adhere to the notice or timing requirements set forth in this part, the enrollee is deemed to have exhausted the MCO's internal appeals process and may initiate a state fair hearing.

C. Requests for appeal of adverse actions made by the LDSS, CPU, or DMAS, or of internal appeal decisions by the MCO shall be submitted to DMAS.

D. Any communication expressing a desire to have an adverse benefit determination by an MCO reviewed shall be treated as a request for an internal appeal. Any communication expressing a desire to have an adverse action by the LDSS, CPU, or DMAS reviewed shall be treated as a request for a state fair hearing. Any communication expressing a desire to have an MCO internal appeal decision reviewed shall be treated as a request for a state fair hearing.

E. To be timely, requests for an internal appeal of an MCO's adverse benefit determination shall be received by the MCO no later than 60 calendar days from the date of the MCO's notice of adverse benefit determination.

F. To be timely, requests for an appeal of an adverse benefit determination upheld in whole or in part by the MCO's internal appeal decision shall be received by DMAS within 120 calendar days from the date of the internal appeal decision.

G. To be timely, requests for appeal of a local department of social services, DMAS, or CPU adverse action shall be filed with DMAS no later than 30 calendar days from the date of the notice of adverse action. Requests for appeal of an agency determination shall be considered filed with DMAS on the date the request is postmarked if mailed, or on the date the request is received if delivered other than by mail, by DMAS.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 7, eff. January 10, 2007; amended, Virginia Register Volume 25, Issue 14, eff. April 15, 2009; Virginia Register Volume 35, Issue 20, eff. June 26, 2019.

12VAC30-141-730 Appeal procedures

A. At a minimum, the MCO internal appeal shall be conducted pursuant to written procedures as defined in § 32.1-137.6 of the Code of Virginia and 42 CFR 438.400 et seq. Such procedures shall be subject to review and approval by DMAS.

B. Any adverse benefit determination upheld in whole or in part by the internal appeal decision issued by the MCO may be appealed by the enrollee to DMAS in accordance with the DMAS client appeals regulations at 12VAC30-110-10 through 12VAC30-110-370. DMAS shall conduct an evidentiary hearing in accordance with 12VAC30-110-10 through 12VAC30-110-370 and shall not base any appealed decision on the record established by any internal appeal decision of the MCO. The MCO shall comply with the DMAS appeal decision. The DMAS decision in these matters shall be final and shall not be subject to appeal by the MCO.

C. Appeals of adverse actions by the LDSS, CPU, or DMAS shall be conducted pursuant to 12VAC30-110.

D. Copies of the procedures shall be promptly provided by the MCO or DMAS to applicants and enrollees upon receipt of timely requests for internal appeals or state fair hearings. Such written procedures shall include the following:

1. The right to representation by an attorney or other agent of the applicant's or enrollee's choice, but at no time shall the MCO, LDSS, DSS, or DMAS be required to obtain or compensate attorneys or other agents acting on behalf of applicants or enrollees;

2. The right to timely review of files and other applicable information relevant to the internal appeal or state fair hearing of the decision;

3. The right to fully participate in the internal appeal or state fair hearing process, whether the internal appeal or state fair hearing is conducted in person or in writing, including the presentation of supplemental information during the internal appeal or state fair hearing process;

4. The right to have personal and medical information and records maintained as confidential;

5. The right to a written final decision:

a. For internal appeals to the MCO, within 30 calendar days of receipt of the request for an internal appeal; or

b. For state fair hearings, within the time limitations for appeals imposed by federal regulations and as permitted in 12VAC30-110-30;

6. For eligibility and enrollment matters, if the applicant's or enrollee's physician or health plan determines that the 90-calendar-day timeframe could seriously jeopardize the applicant's or enrollee's life or health or ability to attain, maintain, or regain maximum function, an applicant or enrollee will have the opportunity to request an expedited appeal. Under these conditions, a request for an expedited appeal shall result in a written final decision within 72 hours after DMAS receives the expedited appeal request from the physician or health plan with the case record and information indicating that taking the time for a standard resolution of the appeal request could seriously jeopardize the applicant's or enrollee's life or health or ability to attain, maintain, or regain maximum function, unless the applicant or enrollee requests an extension;

7. For health services matters for FAMIS MOMS enrollees receiving services through an MCO:

a. If the enrollee's physician or health plan determines that the 30-calendar-day timeframe for a standard internal appeal could seriously jeopardize the enrollee's life, health, or ability to attain, maintain, or regain maximum function, an enrollee will have the opportunity to request an expedited internal appeal. Under these conditions, a request for an internal appeal shall result in a written decision by the MCO within 72 hours from the time the expedited internal appeal is requested, unless the applicant, enrollee, or authorized representative requests a delay. If a delay is requested by the applicant, enrollee, or authorized representative, then expedited internal appeal may be extended up to 14 calendar days.

b. If the adverse benefit determination is upheld in whole or in part by the expedited internal appeal decision issued by the MCO, and if the enrollee's physician or health plan determines that the timeframe for a standard appeal to DMAS could seriously jeopardize the enrollee's life or health or ability to attain, maintain, or regain maximum function, an enrollee will have the opportunity to request an expedited appeal to DMAS. Under these conditions, a request for a state fair hearing shall result in a written decision within 72 hours from the time an enrollee requests the expedited appeal, unless the applicant, enrollee, or authorized representative requests or causes a delay. If a delay is requested by the applicant, enrollee, or authorized representative, then the expedited appeal may be extended up to 14 calendar days; and

8. For health services matters for FAMIS MOMS enrollees receiving services through fee-for-service, if the enrollee's physician or health plan determines that the 90-calendar-day timeframe for a standard appeal could seriously jeopardize the enrollee's life, health, or ability to attain, maintain, or regain maximum function, an enrollee will have the opportunity to request an expedited review. Under these conditions, a request for an expedited appeal shall result in a written decision within 72 hours from the time the expedited appeal is requested, unless the applicant, enrollee, or authorized representative requests or causes a delay. If a delay is requested or caused by the applicant, enrollee, or authorized representative, then expedited appeal may be extended up to 14 calendar days.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 7, eff. January 10, 2007; amended, Virginia Register Volume 30, Issue 12, eff. March 28, 2014; Volume 35, Issue 20, eff. June 26, 2019.

12VAC30-141-740 General conditions of eligibility

A. This section shall be used to determine eligibility of pregnant women for FAMIS MOMS.

B. FAMIS MOMS shall be in effect statewide.

C. Eligible pregnant women must:

1. Be determined ineligible for Medicaid due to excess income by LDSS, by DMAS, or by the CPU;

2. Be a pregnant woman at the time of application;

3. Be a resident of the Commonwealth as described in 12VAC30-141-100 E;

4. Be either a United States citizen, United States national, lawfully residing, or a qualified noncitizen as described in 12VAC30-141-100 E;

5. Be uninsured, that is, not have creditable health insurance coverage; and

6. Not be an inpatient in an institution for mental diseases, or an inmate in a public institution that is not a medical facility.

"Lawfully residing" means the individual is lawfully present in the United States and meets state residency requirements. "Creditable health insurance coverage" means coverage that meets the definition at 42 CFR 457.10.

D. Financial eligibility.

1. Screening. All applications for FAMIS MOMS coverage shall have a Medicaid income eligibility screen completed. Pregnant women determined to be ineligible for Medicaid due to excess income shall have their eligibility for FAMIS MOMS determined.

2. Standards. Income standards for FAMIS MOMS are the same as those described at 12VAC30-141-100 F 2, applied to pregnant women. For purposes of income determination, the family size of the pregnant woman will count the unborn child.

3. Spenddown. DMAS does not apply a spenddown process for FAMIS MOMS where household income exceeds the income eligibility limit for FAMIS MOMS.

E. Coverage under other health plans.

1. Any pregnant woman covered under a group health plan or under health insurance coverage, as defined in § 2791 of the Public Health Services Act (42 USC § 300gg-91(a) and (b)(1)), shall not be eligible for FAMIS MOMS.

2. FAMIS MOMS shall not be a substitution for private insurance.

a. Only uninsured pregnant women shall be eligible for FAMIS MOMS. A pregnant woman is not considered to be insured if the health insurance plan covering the pregnant woman does not have a network of providers in the area where the pregnant woman resides. Each application for FAMIS MOMS coverage shall include an inquiry about health insurance the pregnant woman has at the time of application.

b. Health insurance does not include Medicare, Medicaid, FAMIS or insurance for which DMAS paid premiums under Title XIX through the Health Insurance Premium Payment (HIPP) Program or under Title XXI through the SCHIP premium assistance program.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 7, eff. January 10, 2007; amended, Virginia Register Volume 23, Issue 19, eff. July 1, 2007; Volume 25, Issue 19, eff. July 1, 2009; Volume 26, Issue 6, eff. January 1, 2010; Volume 29, Issue 21, eff. July 17, 2013; Volume 34, Issue 9, eff. January 24, 2018; Volume 35, Issue 20, eff. June 26, 2019.

12VAC30-141-750 Duration of eligibility

A. The effective date of FAMIS MOMS eligibility shall be the first day of the month in which an application was received by LDSS, DMAS, or the CPU if the applicant met all eligibility requirements in that month.

B. Eligibility for FAMIS MOMS will continue through the last day of the month in which the 60th day occurs, following the last day the woman was pregnant, regardless of the reason the pregnancy ended. Eligibility will continue until the end of the coverage period, regardless of changes in circumstances such as income or family size.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 7, eff. January 10, 2007; amended, Virginia Register Volume 35, Issue 20, eff. June 26, 2019.

12VAC30-141-760 Pregnant women ineligible for FAMIS MOMS

A. If a pregnant woman is:

1. Eligible for Medicaid, she shall be ineligible for coverage under FAMIS MOMS;

2. An inmate of a public institution as provided in 42 CFR 435.1009(a)(1), she shall be ineligible for FAMIS MOMS at the initial determination of eligibility; or

3. An inpatient in an institution for mental disease as defined in 42 CFR 435.1010, she shall be ineligible for FAMIS MOMS at the initial determination of eligibility.

B. If a pregnant woman age 18 years or older or, if younger than age 18 years, a parent or other authorized representative does not meet the requirements of assignment of rights to benefits or requirements of cooperation with the agency in identifying and providing information to assist the Commonwealth in pursuing any liable third party, the pregnant woman shall be ineligible for FAMIS MOMS.

C. If a pregnant woman age 18 years or older, or if younger than age 18 years, a parent, adult relative caretaker, guardian, or legal custodian obtained benefits for a pregnant woman who would otherwise be ineligible by willfully misrepresenting material facts on the application or failing to report changes, the pregnant woman for whom the application is made shall be ineligible for FAMIS MOMS. The pregnant woman age 18 years or older, or if younger than age 18 years, the parent, adult relative caretaker, guardian, or legal custodian who signed the application shall be liable for repayment of the cost of all benefits issued as the result of the misrepresentation.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 7, eff. January 10, 2007; amended, Virginia Register Volume 25, Issue 14, eff. April 15, 2009; Volume 34, Issue 9, eff. January 24, 2018; Volume 35, Issue 20, eff. June 26, 2019.

12VAC30-141-770 Nondiscriminatory provisions

FAMIS MOMS shall be conducted in compliance with all civil rights requirements. FAMIS MOMS shall not:

1. Discriminate during the eligibility determination process on the basis of diagnosis;

2. Cover pregnant women of higher income without first covering pregnant women with a lower family income; and

3. Deny eligibility based on a pregnant woman having a preexisting medical condition.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 7, eff. January 10, 2007.

12VAC30-141-780 No entitlement

In accordance with § 2102(b)(4) of the Social Security Act and § 32.1-353 of the Code of Virginia, FAMIS MOMS shall not create any entitlement for, right to, or interest in payment of medical services on the part of any pregnant woman or any right or entitlement to participation.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 7, eff. January 10, 2007.

12VAC30-141-790 Application requirements

A. Availability of program information. DMAS or its designee shall furnish the following information in written form and orally as appropriate to all applicants and to other individuals who request it:

1. The eligibility requirements;

2. Summary of covered benefits;

3. Copayment amounts required; and

4. The rights and responsibilities of applicants and enrollees.

B. Opportunity to apply. DMAS or its designee must afford a pregnant woman, wishing to do so, the opportunity to apply for the FAMIS MOMS program. Applicants may file an application by mail, by fax, by phone, via the internet, or in person at local departments of social services. Face-to-face interviews for the program are not required. Eligibility determinations for FAMIS MOMS shall occur at LDSS, DMAS, or the CPU.

C. Application. DMAS or its designee shall require an application from the applicant if the applicant is at least 18 years of age or older, or from a parent, adult relative caretaker, guardian, legal custodian, or authorized representative if the applicant is younger than 18 years of age or the applicant is incapacitated.

1. DMAS employs a single, streamlined application developed by the state and approved by the Secretary of the Department of Health and Human Services in accordance with § 1413(b)(1)(B) of the Affordable Care Act.

2. DMAS may employ an alternative application used to apply for multiple human service programs approved by the Secretary of the Department of Health and Human Services, provided that the agency makes readily available the single or alternative application used only for insurance affordability programs to individuals seeking assistance only through such programs.

D. Right to apply. An individual who is 18 years of age or older shall not be refused the right to complete an application for health insurance for herself and shall not be discouraged from asking for assistance for herself under any circumstances.

E. Applicant's signature. The applicant must sign state-approved application forms submitted, even if another person fills out the form, unless the application is filed and signed by the applicant's parent, spouse, adult relative caretaker, legal guardian or conservator, attorney-in-fact or authorized representative.

F. The authorized representative for an individual 18 years of age or older shall be those individuals as set forth in 12VAC30-110-1380.

G. The authorized representative for children younger than 18 years of age shall be those individuals as set forth in 12VAC30-110-1390.

H. Persons prohibited from signing an application. An employee of, or an entity hired by, a medical service provider who stands to obtain FAMIS MOMS payments shall not sign an application for health insurance on behalf of an individual who cannot designate an authorized representative.

I. Assistance with application. DMAS or its designee shall allow an individual of the applicant's choice to assist and represent the applicant in the application process, or a renewal process for eligibility.

J. Timely determination of eligibility. The time processing standards for determining eligibility for FAMIS MOMS coverage begin with the date an application is submitted online, by telephone, by fax, or received in hard copy at a local department of social services or the CPU. All applications shall have an eligibility determination for Medicaid for pregnant women and FAMIS MOMS performed within the Medicaid case processing time standards (10 business days) if all information necessary to make the determination has been received.

K. Notice of the decision concerning eligibility. DMAS, an LDSS, or the CPU shall send each applicant a written notice of the agency's or designee's decision on the applicant's application, and if approved, the applicant's obligations under the program. If eligibility for FAMIS MOMS is denied, notice shall be given concerning the reasons for the action and an explanation of the applicant's right to request a review of the adverse actions, as described in 12VAC30-141-50.

L. Case documentation. DMAS, the local department of social services, or the CPU shall include in each applicant's record all necessary facts to support the decision on the applicant's application and shall dispose of each application by a finding of eligibility or ineligibility, unless (i) there is an entry in the case record that the applicant voluntarily withdrew the application and that the agency or its designee sent a notice confirming the applicant's decision or (ii) there is a supporting entry in the case record that the applicant cannot be located.

M. Case maintenance. All cases approved for FAMIS MOMS shall be maintained at departments of social services or the CPU. The LDSS or the agency determining eligibility will be responsible for providing newly enrolled recipients with program information, benefits available, how to secure services under the program, a FAMIS MOMS handbook, and for processing changes in eligibility within established timeframes. DMAS outreach resources may also provide information or assistance to the enrollee.

N. Notice of decision concerning eligibility. LDSS, DMAS, or the CPU must give enrollees timely notice of proposed action to terminate their eligibility under FAMIS MOMS. The notice must meet the requirements of 42 CFR 457.1180.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 7, eff. January 10, 2007; amended, Virginia Register Volume 35, Issue 20, eff. June 26, 2019.

12VAC30-141-800 Copayments

A. Pregnant women enrolled in FAMIS MOMS will be subject to copayments for medical services in the same manner and amount as pregnant women covered by the Medicaid program as defined in 12VAC30-10-570 B and C.

B. These cost-sharing provisions shall be implemented with the following restrictions:

1. Total cost sharing for a pregnant woman shall be limited to (i) for families with incomes equal to or less than 150% of federal poverty level (FPL), the lesser of (a) $180 and (b) 2.5% of the family's income for the year; and (ii) for families with incomes greater than 150% of FPL, the lesser of $350 and 5.0% of the family's income for the year for the duration of the pregnant woman's enrollment in FAMIS MOMS.

2. If a family includes a pregnant woman enrolled in FAMIS MOMS and a child enrolled in FAMIS, DMAS or its designee shall ensure that the annual aggregate cost sharing for all Title XXI enrollees in a family does not exceed the cost sharing caps as defined in 12VAC30-141-160 B.

3. Families will be required to submit documentation to DMAS or its designee showing that their maximum copayment amounts are met for the year.

4. Once the cap is met, DMAS or its designee will issue a new eligibility card or written documentation excluding such families from paying additional copays.

C. Exceptions to the above cost-sharing provisions. No cost sharing will be charged to American Indians and Alaska Natives.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 7, eff. January 10, 2007; amended, Virginia Register Volume 35, Issue 20, eff. June 26, 2019.

12VAC30-141-810 Liability for excess benefits

A. Any person who, without the intent to violate this section, obtains benefits or payments under FAMIS MOMS to which she is not entitled shall be liable for any excess benefits or payments received. If the enrollee knew or reasonably should have known that she was not entitled to the excess benefits, she may also be liable for interest on the amount of the excess benefits or payments at the judgment rate as defined in § 6.1-330.54 of the Code of Virginia from the date upon which excess benefits or payments to the date on which repayment is made to the Commonwealth. No person shall be liable for payment of interest, however, when excess benefits or payments were obtained as a result of errors made solely by DMAS or its designee.

B. Any payment erroneously made on behalf of a FAMIS MOMS enrollee or former enrollee may be recovered by DMAS from the enrollee or the enrollee's income, assets, or estate unless state or federal law or regulation otherwise exempts such property.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 7, eff. January 10, 2007.

12VAC30-141-820 Benefit packages

Pregnant women covered through FAMIS MOMS may receive the same medical and dental services and are subject to the same limitations on services as pregnant women (see 12VAC30-50-190) covered by the Medicaid program as defined in 12VAC30-10-140 and 12VAC30-50-10.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 7, eff. January 10, 2007; amended, Virginia Register Volume 32, Issue 22, eff. July 27, 2016.

12VAC30-141-830 Benefits reimbursement

A. Reimbursement for the services covered under FAMIS MOMS fee-for-service and MCHIPs shall be as specified in this section.

B. Reimbursement for physician services, surgical services, clinic services, prescription drugs, laboratory and radiological services, outpatient mental health services, early intervention services, emergency services, home health services, immunizations, mammograms, medical transportation, organ transplants, skilled nursing services, well baby and well child care, vision services, durable medical equipment, disposable medical supplies, dental services, case management services, physical therapy/occupational therapy/speech-language therapy services, hospice services, school-based health services, and certain community-based mental health services shall be based on the Title XIX rates.

C. Reimbursement to MCHIPs shall be determined on the basis of the estimated cost of providing the MCHIP benefit package and services to an actuarially equivalent population. MCHIP rates will be determined annually and published 30 days prior to the effective date.

D. Exceptions.

1. Prior authorization is required after five visits in a fiscal year for physical therapy, occupational therapy and speech therapy provided by home health providers and outpatient rehabilitation facilities and for home health skilled nursing visits. Prior authorization is required after five visits for outpatient mental health visits in the first year of service and prior authorization is required for the following nonemergency outpatient procedures: Magnetic Resonance Imaging, Computer Axial Tomography scans, or Positron Emission Tomography scans.

2. Reimbursement for inpatient hospital services will be based on the Title XIX rates in effect for each hospital. Reimbursement shall not include payments for disproportionate share or graduate medical education payments made to hospitals. Payments made shall be final and there shall be no retrospective cost settlements.

3. Reimbursement for outpatient hospital services shall be based on the Title XIX rates in effect for each hospital. Payments made will be final and there will be no retrospective cost settlements.

4. Reimbursement for inpatient mental health services other than by free standing psychiatric hospitals will be based on the Title XIX rates in effect for each hospital. Reimbursement will not include payments for disproportionate share or graduate medical education payments made to hospitals. Payments made will be final and there will be no retrospective cost settlements.

5. Reimbursement for outpatient rehabilitation services will be based on the Title XIX rates in effect for each rehabilitation agency. Payments made will be final and there will be no retrospective cost settlements.

6. Reimbursement for outpatient substance abuse treatment services will be based on rates determined by DMAS for children ages six through 18 years. Payments made will be final and there will be no retrospective cost settlements.

7. Reimbursement for prescription drugs will be based on the Title XIX rates in effect. Reimbursements for Title XXI do not receive drug rebates as under Title XIX.

8. Reimbursement for covered prescription drugs for non-institutionalized FAMIS MOMS individuals receiving the fee-for-service benefits will be subject to review and prior authorization when their current number of prescriptions exceeds nine unique prescriptions within 180 days, and as may be further defined by the agency's guidance documents for pharmacy utilization review and the prior authorization program. The prior authorization process shall be applied consistent with the process set forth in 12VAC30-50-210 A 7.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 7, eff. January 10, 2007; amended, Virginia Register Volume 30, Issue 12, eff. March 28, 2014.

12VAC30-141-840 Quality assurance

A. Each provider entity shall meet requirements for the following either as administered by DMAS or as determined by contract with DMAS: access to well-child health services, immunizations, provider network adequacy, a system to provide enrollees urgent care and emergency services, systems for complaints, grievances and reviews, a data management system and quality improvement programs and activities.

B. Each MCHIP shall meet requirements determined by the contract for the internal and external quality monitoring and reporting of access to services, timeliness of services, and appropriateness of services, as determined by DMAS.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 7, eff. January 10, 2007.

12VAC30-141-850 Utilization control

A. Each MCHIP shall implement a utilization review system as determined by contract with DMAS, or administered by DMAS.

B. For the fee-for-service program, DMAS shall use the utilization controls already established and operational in the State Plan for Medical Assistance.

C. DMAS may collect and review comprehensive data to monitor utilization after receipt of services.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 7, eff. January 10, 2007; amended, Virginia Register Volume 30, Issue 12, eff. March 28, 2014.

12VAC30-141-860 Recipient audit unit

A. Pursuant to Chapter 9 (§ 32.1-310 et seq.) of Title 32.1 of the Code of Virginia, the recipient audit unit shall investigate allegations of acts of fraud or abuse, committed by persons enrolled in the FAMIS MOMS program or the parent, adult caretaker relative, guardian, legal custodian or authorized representative on behalf of a person or persons enrolled in the FAMIS MOMS program, which result in misspent funds.

B. Any FAMIS MOMS enrollee, parent, adult caretaker relative, guardian, legal custodian or authorized representative of a FAMIS MOMS enrollee who, on the behalf of others, attempts to obtain benefits to which the enrollee is not entitled by means of a willful false statement or by willful misrepresentation, or by willful concealment of any material facts, shall be liable for repayment of any excess benefits received and the appropriate interest charges.

C. Upon the determination that fraud or abuse has been committed, criminal or civil action may be initiated.

D. When determining the amount of misspent funds to be recovered, capitation fees shall be included for FAMIS MOMS enrollees who received benefits through managed care.

E. Access to FAMIS MOMS enrollees' records by authorized DMAS representatives shall be permitted upon request.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 7, eff. January 10, 2007.

12VAC30-141-870 Provider review

A. The provider review unit shall be responsible for reviewing enrolled FAMIS MOMS providers to identify potential inappropriate utilization of services and potential billing errors.

B. Providers agree to keep such records as DMAS determines necessary. The providers shall furnish DMAS, upon request, information regarding payments claimed for providing services under the State Plan for Title XXI.

C. Access to records and facilities by authorized DMAS representatives shall be permitted upon request.

D. Providers shall be required to refund payments made by DMAS if they are found to have billed DMAS contrary to policy, failed to maintain records or adequate documentation to support their claims, or billed for medically unnecessary services.

E. A review of adverse actions concerning provider reimbursement shall be heard in accordance with the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) and the Virginia Administrative Code, 12VAC30-10-1000 and 12VAC30-20-500 through 12VAC30-20-560.

F. MCHIPs shall be responsible for keeping provider profile and utilization mechanisms to monitor provider activities. MCHIPs shall be reviewed by DMAS.

History

• Statutory Authority: §§ 32.1-324 and 32.1-325 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 7, eff. January 10, 2007.

12VAC30-141-880 Assignment to managed care

A. All eligible enrollees shall be assigned in managed care through the department or the central processing unit (CPU) under contract to DMAS. FAMIS MOMS individuals, during the preassignment period to an MCHIP, shall receive Medicaid-like benefits via fee-for-service utilizing a FAMIS MOMS card issued by DMAS. After assignment to an MCHIP, benefits and the delivery of benefits shall be administered specific to the managed care program in which the individual is enrolled.

1. MCHIPs shall be offered to enrollees in all areas.

2. All enrollees shall be assigned to that contracted MCHIP.

3. Enrollees shall be assigned through a random system algorithm.

4. Enrolled individuals will receive a letter indicating that they may select one of the contracted MCHIPs that serve such area. Enrollees who do not select an MCHIP as described above, shall be assigned to an MCHIP as described in subdivision 3 of this subsection.

5. Individuals assigned to an MCHIP who lose and then regain eligibility for FAMIS MOMS within 60 days will be reassigned to their previous MCHIP.

B. Following their initial assignment to an MCHIP, those enrollees shall be restricted to that MCHIP until their next annual eligibility redetermination, unless appropriately disenrolled by the department.

1. During the first 90 days of managed care assignment, an enrollee may request reassignment for any reason from that MCHIP to another MCHIP serving that geographic area. Such reassignment shall be effective no later than the first day of the second month after the month in which the enrollee requests reassignment.

2. After the first 90 calendar days of the assignment period, the enrollee may only be reassigned from one MCHIP to another MCHIP upon determination by DMAS that good cause exists pursuant to subsection C of this section.

C. Disenrollment for good cause may be requested at any time.

1. After the first 90 days of assignment in managed care, enrollees may request disenrollment from DMAS based on good cause. The request must be made in writing to DMAS and cite the reasons why the enrollee wishes to be reassigned. DMAS shall establish procedures for good cause reassignment through written policy directives.

2. DMAS shall determine whether good cause exists for reassignment.

History

• Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 7, eff. January 10, 2007; amended, Virginia Register Volume 30, Issue 12, eff. March 28, 2014; Volume 35, Issue 20, eff. June 26, 2019; Volume 36, Issue 6, eff. December 27, 2019.

Agency 35 Department of Behavioral Health And Developmental Services

Chapter 12 Public Participation Guidelines

Part I Purpose and Definitions

12VAC35-12-10 Purpose

The purpose of this chapter is to promote public involvement in the development, amendment or repeal of the regulations of the State Board of Behavioral Health and Developmental Services and the Department of Behavioral Health and Developmental Services. This chapter does not apply to regulations, guidelines, or other documents exempted or excluded from the provisions of the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

History

• Statutory Authority: §§ 2.2-4007.02 and 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008; amended, Virginia Register Volume 25, Issue 26, eff. October 15, 2009.

12VAC35-12-20 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Administrative Process Act" means Chapter 40 (§ 2.2-4000 et seq.) of Title 2.2 of the Code of Virginia.

"Agency" means the entity of state government empowered by the agency's basic law to make regulations or decide cases. This term includes the State Board of Behavioral Health and Developmental Services and the Department of Behavioral Health and Developmental Services. Actions specified in this chapter may be fulfilled by state employees as delegated by the agency.

"Basic law" means provisions in the Code of Virginia that delineate the basic authority and responsibilities of an agency.

"Commonwealth Calendar" means the electronic calendar for official government meetings open to the public as required by § 2.2-3707 C of the Freedom of Information Act.

''Negotiated rulemaking panel'' or ''NRP'' means an ad hoc advisory panel of interested parties established by an agency to consider issues that are controversial with the assistance of a facilitator or mediator, for the purpose of reaching a consensus in the development of a proposed regulatory action.

"Notification list" means a list used to notify persons pursuant to this chapter. Such a list may include an electronic list maintained through the Virginia Regulatory Town Hall or other list maintained by the agency.

"Open meeting" means any scheduled gathering of a unit of state government empowered by an agency's basic law to make regulations or decide cases, which is related to promulgating, amending or repealing a regulation.

"Person" means any individual, corporation, partnership, association, cooperative, limited liability company, trust, joint venture, government, political subdivision, or any other legal or commercial entity and any successor, representative, agent, agency, or instrumentality thereof.

"Public hearing" means a scheduled time at which members or staff of the agency will meet for the purpose of receiving public comment on a regulatory action.

"Regulation" means any statement of general application having the force of law, affecting the rights or conduct of any person, adopted by the agency in accordance with the authority conferred on it by applicable laws.

"Regulatory action" means the promulgation, amendment, or repeal of a regulation by the agency.

"Regulatory advisory panel" or "RAP" means a standing or ad hoc advisory panel of interested parties established by the agency for the purpose of assisting in regulatory actions.

"Town Hall" means the Virginia Regulatory Town Hall, the website operated by the Virginia Department of Planning and Budget at www.townhall.virginia.gov, which has online public comment forums and displays information about regulatory meetings and regulatory actions under consideration in Virginia and sends this information to registered public users.

"Virginia Register" means the Virginia Register of Regulations, the publication that provides official legal notice of new, amended and repealed regulations of state agencies, which is published under the provisions of Article 6 (§ 2.2-4031 et seq.) of the Administrative Process Act.

History

• Statutory Authority: §§ 2.2-4007.02 and 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008; amended, Virginia Register Volume 25, Issue 26, eff. October 15, 2009.

Part II Notification of Interested Persons

12VAC35-12-30 Notification list

A. The agency shall maintain a list of persons who have requested to be notified of regulatory actions being pursued by the agency.

B. Any person may request to be placed on a notification list by registering as a public user on the Town Hall or by making a request to the agency. Any person who requests to be placed on a notification list shall elect to be notified either by electronic means or through a postal carrier.

C. The agency may maintain additional lists for persons who have requested to be informed of specific regulatory issues, proposals, or actions.

D. When electronic mail is returned as undeliverable on multiple occasions at least 24 hours apart, that person may be deleted from the list. A single undeliverable message is insufficient cause to delete the person from the list.

E. When mail delivered by a postal carrier is returned as undeliverable on multiple occasions, that person may be deleted from the list.

F. The agency may periodically request those persons on the notification list to indicate their desire to either continue to be notified electronically, receive documents through a postal carrier, or be deleted from the list.

History

• Statutory Authority: §§ 2.2-4007.02 and 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008.

12VAC35-12-40 Information to be sent to persons on the notification list

A. To persons electing to receive electronic notification or notification through a postal carrier as described in 12VAC35-12-30, the agency shall send the following information:

1. A notice of intended regulatory action (NOIRA).

2. A notice of the comment period on a proposed, a reproposed, or a fast-track regulation and hyperlinks to, or instructions on how to obtain, a copy of the regulation and any supporting documents.

3. A notice soliciting comment on a final regulation when the regulatory process has been extended pursuant to § 2.2-4007.06 or 2.2-4013 C of the Code of Virginia.

B. The failure of any person to receive any notice or copies of any documents shall not affect the validity of any regulation or regulatory action.

History

• Statutory Authority: §§ 2.2-4007.02 and 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008.

12VAC35-12-45 Notification to licensed providers

To providers licensed by the department, the department shall send the following information:

1. At or prior to the time a new regulation relating to licensed providers is posted to the Virginia Regulatory Town Hall, the department shall provide direct notice to licensed providers affected by the new regulatory change that such change has been initiated.

2. At the time that the final stage of a regulation is posted to the Virginia Regulatory Town Hall, the department shall provide direct notice to licensed providers affected by the regulatory change that such final stage has been posted.

History

• Statutory Authority: §§ 2.2-4007-02 and 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 34, Issue 11, eff. March 8, 2018.

Part III Public Participation Procedures

12VAC35-12-50 Public comment

A. In considering any nonemergency, nonexempt regulatory action, the agency shall afford interested persons an opportunity to (i) submit data, views, and arguments, either orally or in writing, to the agency; and (ii) be accompanied by and represented by counsel or other representative. Such opportunity to comment shall include an online public comment forum on the Town Hall.

1. To any requesting person, the agency shall provide copies of the statement of basis, purpose, substance, and issues; the economic impact analysis of the proposed or fast-track regulatory action; and the agency's response to public comments received.

2. The agency may begin crafting a regulatory action prior to or during any opportunities it provides to the public to submit comments.

B. The agency shall accept public comments in writing after the publication of a regulatory action in the Virginia Register as follows:

1. For a minimum of 30 calendar days following the publication of the notice of intended regulatory action (NOIRA).

2. For a minimum of 60 calendar days following the publication of a proposed regulation.

3. For a minimum of 30 calendar days following the publication of a reproposed regulation.

4. For a minimum of 30 calendar days following the publication of a final adopted regulation.

5. For a minimum of 30 calendar days following the publication of a fast-track regulation.

6. For a minimum of 21 calendar days following the publication of a notice of periodic review.

7. Not later than 21 calendar days following the publication of a petition for rulemaking.

C. The agency may determine if any of the comment periods listed in subsection B of this section shall be extended.

D. At the time any change to guidance documents related to licensure requirements is being developed, the agency shall provide direct notice to licensed providers affected by the change that such change has been initiated. The agency shall post the proposed change to the Virginia Regulatory Town Hall, to include a public comment forum for a period of 30 days. Such notice shall include a description of the change and provide contact information for the agency's designated contact person. If it is anticipated that the change shall have an impact on staffing or payment matters for the affected stakeholders, the direct notice to stakeholders shall note this fact and request specific comments regarding an appropriate timeframe for the implementation of such changes.

E. Prior to the adoption, amendment, or repeal of any regulation regarding substance abuse services, the board shall, in addition to the procedures set forth in the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia), present the proposed regulation to the Substance Abuse Services Council, established pursuant to § 2.2-2696 of the Code of Virginia, at least 30 days prior to the board's action for the council's review and comment.

F. If the Governor finds that one or more changes with substantial impact have been made to a proposed regulation, he may require the agency to provide an additional 30 calendar days to solicit additional public comment on the changes in accordance with § 2.2-4013 C of the Code of Virginia.

G. The agency shall send a draft of the agency's summary description of public comment to all public commenters on the proposed regulation at least five days before final adoption of the regulation pursuant to § 2.2-4012 E of the Code of Virginia.

History

• Statutory Authority: §§ 2.2-4007.02 and 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008; amended, Virginia Register Volume 34, Issue 11, eff. March 8, 2018.

12VAC35-12-60 Petition for rulemaking

A. As provided in § 2.2-4007 of the Code of Virginia, any person may petition the agency to consider a regulatory action.

B. A petition shall include but is not limited to the following information:

1. The petitioner's name and contact information;

2. The substance and purpose of the rulemaking that is requested, including reference to any applicable Virginia Administrative Code sections; and

3. Reference to the legal authority of the agency to take the action requested.

C. The agency shall receive, consider and respond to a petition pursuant to § 2.2-4007 and shall have the sole authority to dispose of the petition.

D. The petition shall be posted on the Town Hall and published in the Virginia Register.

E. Nothing in this chapter shall prohibit the agency from receiving information or from proceeding on its own motion for rulemaking.

History

• Statutory Authority: §§ 2.2-4007.02 and 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008.

12VAC35-12-70 Appointment of regulatory advisory panel

A. The agency may appoint a regulatory advisory panel (RAP) to provide professional specialization or technical assistance when the agency determines that such expertise is necessary to address a specific regulatory issue or action or when individuals indicate an interest in working with the agency on a specific regulatory issue or action.

B. Any person may request the appointment of a RAP and request to participate in its activities. The agency shall determine when a RAP shall be appointed and the composition of the RAP.

C. A RAP may be dissolved by the agency if:

1. The proposed text of the regulation is posted on the Town Hall, published in the Virginia Register, or such other time as the agency determines is appropriate; or

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act.

History

• Statutory Authority: §§ 2.2-4007.02 and 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008.

12VAC35-12-80 Appointment of negotiated rulemaking panel

A. The agency may appoint a negotiated rulemaking panel (NRP) if a regulatory action is expected to be controversial.

B. An NRP that has been appointed by the agency may be dissolved by the agency when:

1. There is no longer controversy associated with the development of the regulation;

2. The agency determines that the regulatory action is either exempt or excluded from the requirements of the Administrative Process Act; or

3. The agency determines that resolution of a controversy is unlikely.

History

• Statutory Authority: §§ 2.2-4007.02 and 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008.

12VAC35-12-90 Meetings

Notice of any open meeting, including meetings of a RAP or NRP, shall be posted on the Virginia Regulatory Town Hall and Commonwealth Calendar at least seven working days prior to the date of the meeting. The exception to this requirement is any meeting held in accordance with § 2.2-3707 D of the Code of Virginia allowing for contemporaneous notice to be provided to participants and the public.

History

• Statutory Authority: §§ 2.2-4007.02 and 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008.

12VAC35-12-100 Public hearings on regulations

A. The agency shall indicate in its notice of intended regulatory action whether it plans to hold a public hearing following the publication of the proposed stage of the regulatory action.

B. The agency may conduct one or more public hearings during the comment period following the publication of a proposed regulatory action.

C. An agency is required to hold a public hearing following the publication of the proposed regulatory action when:

1. The agency's basic law requires the agency to hold a public hearing;

2. The Governor directs the agency to hold a public hearing; or

3. The agency receives requests for a public hearing from at least 25 persons during the public comment period following the publication of the notice of intended regulatory action.

D. Notice of any public hearing shall be posted on the Town Hall and Commonwealth Calendar at least seven working daysprior to the date of the hearing. The agency shall also notify those persons who requested a hearing under subdivision C 3 of this section.

History

• Statutory Authority: §§ 2.2-4007.02 and 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008.

12VAC35-12-110 Periodic review of regulations

A. The agency shall conduct a periodic review of its regulations consistent with:

1. An executive order issued by the Governor pursuant to § 2.2-4017 of the Administrative Process Act to receive comment on all existing regulations as to their effectiveness, efficiency, necessity, clarity, and cost of compliance; and

2. The requirements in § 2.2-4007.1 of the Administrative Process Act regarding regulatory flexibility for small businesses.

B. A periodic review may be conducted separately or in conjunction with other regulatory actions.

C. Notice of a periodic review shall be posted on the Town Hall and published in the Virginia Register.

History

• Statutory Authority: §§ 2.2-4007.02 and 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 2, eff. October 29, 2008.

Chapter 46 Regulations for Children's Residential Facilities

Part I General Provisions

12VAC35-46-10 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise.

"Allegation" means an accusation that a facility is operating without a license or receiving public funds for services it is not certified to provide.

"Allied health professional" means a professional who is involved with the delivery of health or related services pertaining to the identification, evaluation, and prevention of diseases and disorders, such as a certified substance abuse counselor, certified substance abuse counseling assistant, peer recovery support specialist, certified nurse aide, or occupational therapist.

"Annual" means within 13 months of the previous event or occurrence.

"Applicable state regulation" means any regulation that the department determines applies to the facility. The term includes, but is not necessarily limited to, regulations promulgated by the Departments of Education, Health, Housing and Community Development, or other state agencies.

"Applicant" means the person, corporation, partnership, association, or public agency that has applied for a license.

"ASAM" means the American Society of Addiction Medicine.

"Aversive stimuli" means the physical forces (e.g., sound, electricity, heat, cold, light, water, or noise) or substances (e.g., hot pepper sauce or pepper spray) measurable in duration and intensity that when applied to a resident are noxious or painful to the resident but in no case shall the term "aversive stimuli" include striking or hitting the individual with any part of the body or with an implement or pinching, pulling, or shaking the resident.

"Behavior support" means those principles and methods employed by a provider to help a child achieve positive behavior and to address and correct a child's inappropriate behavior in a constructive and safe manner in accordance with written policies and procedures governing program expectations, treatment goals, child and staff safety and security, and the child's individualized service plan.

"Behavior support assessment" means identification of a resident's behavior triggers, successful intervention strategies, anger and anxiety management options for calming, techniques for self-management, and specific goals that address the targeted behaviors that lead to emergency safety interventions.

"Body cavity search" means any examination of a resident's rectal or vaginal cavities, except the performance of medical procedures by medical personnel.

"Brain injury" means any injury to the brain that occurs after birth, but before age 65, that is acquired through traumatic or nontraumatic insults. Nontraumatic insults may include anoxia, hypoxia, aneurysm, toxic exposure, encephalopathy, surgical interventions, tumor, and stroke. Brain injury does not include hereditary, congenital, or degenerative brain disorders, or injuries induced by birth trauma.

"Brain Injury Waiver" means a Virginia Medicaid home and community-based waiver for persons with brain injury approved by the Centers for Medicare and Medicaid Services.

"Care" or "treatment" means a set of individually planned interventions, training, habilitation, or supports that help a resident obtain or maintain an optimal level of functioning, reduce the effects of disability or discomfort, or ameliorate symptoms, undesirable changes, or conditions specific to physical, mental, behavioral, or social functioning.

"Child" means any person legally defined as a child under state law. The term includes residents and other children coming into contact with the resident or facility (e.g., visitors). When the term is used, the requirement applies to every child at the facility regardless of whether the child has been admitted to the facility for care (e.g., staff to child ratios apply to all children present even though some may not be residents).

"Child-placing agency" means any person licensed to place children in foster homes or adoptive homes or a local board of social services authorized to place children in foster homes or adoptive homes.

"Children's residential facility" or "facility" means a publicly or privately operated facility, other than a private family home, where 24-hour per day care is provided to children separated from their legal guardians and is required to be licensed or certified by the Code of Virginia except:

1. Any facility licensed by the Department of Social Services as a child-caring institution as of January 1, 1987, and that receives public funds; and

2. Acute-care private psychiatric hospitals serving children that are licensed by the Department of Behavioral Health and Developmental Services under the Rules and Regulations for Licensing Providers by the Department of Behavioral Health and Developmental Services, 12VAC35-105.

"Clinically managed, low-intensity residential care" or "Level of care 3.1" means providing an ongoing therapeutic environment for children requiring some structured support in which treatment is directed toward applying recovery skills; preventing relapse; improving emotional functioning; promoting personal responsibility; reintegrating the child into work, education, and family environments; and strengthening adaptive skills that may not have been achieved or have been diminished during the child's active addiction. A clinically managed, low-intensity residential care is also designed for the child suffering from chronic, long-term alcoholism or drug addiction and affords an extended period of time to establish sound recovery and a solid support system.

"Clinically managed, medium-intensity residential care" or "Level of care 3.5" means a substance use treatment program that offers 24-hour supportive treatment of children with significant psychological and social problems by credentialed addiction treatment professionals in an interdisciplinary treatment approach. The children served by clinically managed, medium-intensity residential care are children who are not sufficiently stable to benefit from outpatient treatment regardless of intensity of service.

"Commissioner" means the Commissioner of the Department of Behavioral Health and Developmental Services or his authorized agent.

"Complaint" means an accusation against a licensed facility regarding an alleged violation of regulations or law.

"Contraband" means any item prohibited by law or by the rules and regulations of the department, or any item that conflicts with the program or safety and security of the facility or individual residents.

"Corporal punishment" means punishment administered through the intentional inflicting of pain and discomfort to the body through actions such as, but not limited to (i) striking or hitting with any part of the body or with an implement; or (ii) any similar action that normally inflicts pain or discomfort.

"Counseling" means certain formal treatment interventions such as individual, family, and group modalities that provide for support and problem solving. Such interventions take place between provider staff and resident families or groups and are aimed at enhancing appropriate psychosocial functioning or personal sense of well-being.

"Corrective action plan" means the provider's pledged corrective action in response to cited areas of noncompliance documented by the department. A corrective action plan must be completed within a specified time.

"Crisis" means any acute emotional disturbance in which a resident presents an immediate danger to self or others or is at risk of serious mental or physical health deterioration caused by acute mental distress, behavioral or situational factors, or acute substance abuse related problems.

"Crisis intervention" means those activities aimed at the rapid management of a crisis.

"Day" means calendar day unless the context clearly indicates otherwise.

"Department" or "DBHDS" means the Department of Behavioral Health and Developmental Services.

"Developmental disability" means a severe, chronic disability of an individual that (i) is attributable to a mental or physical impairment or a combination of mental and physical impairments other than a sole diagnosis of mental illness; (ii) is manifested before the individual reaches 22 years of age; (iii) is likely to continue indefinitely; (iv) results in substantial functional limitations in three or more of the following areas of major life activity: self-care, receptive and expressive language, learning, mobility, self-direction, capacity for independent living, or economic self-sufficiency; and (v) reflects the individual's need for a combination and sequence of special interdisciplinary or generic services, individualized supports, or other forms of assistance that are of lifelong or extended duration and are individually planned and coordinated. An individual from birth to nine years of age, inclusive, who has a substantial developmental delay or specific congenital or acquired condition may be considered to have a developmental disability without meeting three or more of the criteria described in clauses (i) through (v) if the individual without services and supports has a high probability of meeting those criteria later in life.

"Diagnostic and Statistical Manual of Mental Disorders" or "DSM" means the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, DSM-5, of the American Psychiatric Association.

"DOE" means the Department of Education.

"Emergency" means a sudden, generally unexpected occurrence or set of circumstances demanding immediate action. Emergency does not include regularly scheduled time off for permanent staff or other situations that should reasonably be anticipated.

"Emergency admission" means the sudden, unplanned, unexpected admittance of a child who needs immediate care or a court-ordered placement.

"Goal" means expected results or conditions that usually involve a long period of time and that are written in behavioral terms in a statement of relatively broad scope. Goals provide guidance in establishing specific short-term objectives directed toward the attainment of the goal.

"Good character and reputation" means findings have been established and knowledgeable and objective people agree that the individual maintains business or professional, family, and community relationships that are characterized by honesty, fairness, truthfulness, and dependability, and has a history or pattern of behavior that demonstrates that the individual is suitable and able to care for, supervise, and protect children. Relatives by blood or marriage, and persons who are not knowledgeable of the individual, such as recent acquaintances, shall not be considered objective references.

"Group home" means a children's residential facility that is a community-based, homelike single dwelling, or its acceptable equivalent, other than the private home of the operator, and serves up to 12.

"Health record" means the file maintained by the provider that contains personal health information.

"Human research" means any systematic investigation including research development, testing, and evaluation, utilizing human subjects, that is designed to develop or contribute to generalized knowledge. Human research shall not include research exempt from federal research regulations pursuant to 45 CFR 46.101(b).

"Immediately" means directly without delay.

"Independent living program" means a competency-based program that is specifically approved by the department to provide the opportunity for the residents to develop the skills necessary to live successfully on their own following completion of the program.

"Individualized service plan" means a written plan of action developed and modified at intervals to meet the needs of a specific resident. It specifies measurable short and long-term goals, objectives, strategies, and time frames for reaching the goals and the individuals responsible for carrying out the plan.

"Intellectual disability" means a disability originating before 18 years of age, characterized concurrently by (i) significant subaverage intellectual functioning as demonstrated by performance on a standardized measure of intellectual functioning administered in conformity with accepted professional practice that is at least two standard deviations below the mean and (ii) significant limitations in adaptive behavior as expressed in conceptual, social, and practical adaptive skills.

"Legal guardian" means the natural or adoptive parents or other person, agency, or institution that has legal custody of a child.

"License" means a document verifying approval to operate a children's residential facility and that indicates the status of the facility regarding compliance with applicable state regulations.

"Live-in staff" means staff who are required to be on duty for a period of 24 consecutive hours or more during each work week.

"Living unit" means the space in which a particular group of children in care of a residential facility reside. A living unit contains sleeping areas, bath and toilet facilities, and a living room or its equivalent for use by the residents of the unit. Depending upon its design, a building may contain one living unit or several separate living units.

"Mechanical restraint" means the use of a mechanical device that cannot be removed by the individual to restrict the freedom of movement or functioning of a limb or a portion of an individual's body when that behavior places him or others at imminent risk.

"Medication" means prescribed and over-the-counter drugs.

"Medication administration" means the direct application of medications by injection, inhalation, or ingestion or any other means to a resident by (i) persons legally permitted to administer medications; or (ii) the resident at the direction and in the presence of persons legally permitted to administer medications.

"Medication assisted treatment" or "MAT" means the use of U.S. Food and Drug Administration-approved medications in combination with counseling and behavioral therapies to provide treatment of substance use disorders.

"Medication error" means an error made in administering a medication to a resident including the following: (i) the wrong medication is given to the resident; (ii) the wrong resident is given the medication; (iii) the wrong dosage is given to a resident; (iv) medication is given to a resident at the wrong time or not at all; and (v) the proper method is not used to give the medication to the resident. A medication error does not include a resident's refusal of offered medication.

"Motivational enhancement" means a person-centered approach that is collaborative, employs strategies to strengthen motivation for change, increases engagement in substance use services, resolves ambivalence about changing substance use behaviors, and supports individuals to set goals to change their substance use.

"Neurobehavioral services" means the assessment, evaluation, and treatment of cognitive, perceptual, behavioral, and other impairments caused by brain injury, that affect an individual's ability to function successfully in the community.

"Objective" means expected short-term results or conditions that must be met in order to attain a goal. Objectives are stated in measurable, behavioral terms and have a specified time for achievement.

"On-duty" means that period of time during which a staff person is responsible for the supervision of one or more children.

"On-site" means services that are delivered by the provider and are an integrated part of the overall service delivery system.

"Parent" means a natural or adoptive parent or surrogate parent appointed pursuant to DOE's regulations governing special education programs for students with disabilities. "Parent" means either parent unless the facility has been provided documentation that there is a legally binding instrument, a state law, or court order governing such matters as divorce, separation, or custody, that provides to the contrary.

"Pat down" means a thorough external body search of a clothed resident.

"Personal health information" means oral, written, or otherwise recorded information that is created or received by an entity relating to either an individual's physical or mental health or the provision of or payment for health care to an individual.

"Placement" means an activity by any person that provides assistance to a parent or legal guardian in locating and effecting the movement of a child to a foster home, adoptive home, or children's residential facility.

"Premises" means the tracts of land on which any part of a residential facility for children is located and any buildings on such tracts of land.

"Provider" means any person, entity, or organization, excluding an agency of the federal government by whatever name or designation, that delivers (i) residential services to children with mental illness, developmental disability, or substance abuse; or (ii) residential services for persons with brain injury.

"Record" means up-to-date written or automated information relating to one resident. This information includes social data, agreements, all correspondence relating to the care of the resident, service plans with periodic revisions, aftercare plans and discharge summary, and any other data related to the resident.

"Resident" means a person admitted to a children's residential facility for supervision, care, training, or treatment on a 24-hour per day basis.

"Residential treatment program" means 24-hour, supervised, medically necessary, out-of-home programs designed to provide necessary support and address mental health, behavioral, substance abuse, cognitive, or training needs of a child or adolescent in order to prevent or minimize the need for more intensive inpatient treatment. Services include, but shall not be limited to, assessment and evaluation, medical treatment (including medication), individual and group counseling, neurobehavioral services, and family therapy necessary to treat the child. The service provides active treatment or training beginning at admission related to the resident's principle diagnosis and admitting symptoms. These services do not include interventions and activities designed only to meet the supportive nonmental health special needs including personal care, habilitation, or academic educational needs of the resident.

"Respite care facility" means a facility that is specifically approved to provide short-term, periodic residential care to children accepted into its program in order to give the parents or legal guardians temporary relief from responsibility for their direct care.

"Rest day" means a period of not less than 24 consecutive hours during which a staff person has no responsibility to perform duties related to the facility.

"Restraint" means the use of a mechanical device, medication, physical intervention, or hands-on hold to prevent an individual from moving his body to engage in a behavior that places him or others at imminent risk. There are three kinds of restraints:

1. Mechanical restraint means the use of a mechanical device that cannot be removed by the individual to restrict the freedom of movement or functioning of a limb or a portion of an individual's body when that behavior places him or others at imminent risk.

2. Pharmacological restraint means the use of a medication that is administered involuntarily for the emergency control of an individual's behavior when that individual's behavior places him or others at imminent risk and the administered medication is not a standard treatment for the individual's medical or psychiatric condition.

3. Physical restraint, also referred to as manual hold, means the use of a physical intervention or hands-on hold to prevent an individual from moving his body when that individual's behavior places him or others at imminent risk.

"Routine admission" means the admittance of a child following evaluation of an application for admission and execution of a written placement agreement.

"Rules of conduct" means a listing of a facility's rules or regulations that is maintained to inform residents and others about behaviors that are not permitted and the consequences applied when the behaviors occur.

"Sanitizing agent" means any substance approved by the Environmental Protection Agency to destroy bacteria.

"Seclusion" means the involuntary placement of an individual alone in an area secured by a door that is locked or held shut by a staff person by physically blocking the door, or by any other physical or verbal means so that the individual cannot leave it.

"Self-admission" means the admittance of a child who seeks admission to a temporary care facility as permitted by Virginia statutory law without completing the requirements for "routine admission."

"Serious incident" means:

1. Any accident or injury requiring medical attention by a physician;

2. Any illness that requires hospitalization;

3. Any overnight absence from the facility without permission;

4. Any runaway; or

5. Any event that affects, or potentially may affect, the health, safety, or welfare of any resident being served by the provider.

"Serious injury" means any injury resulting in bodily hurt, damage, harm, or loss that requires medical attention by a licensed physician.

"Service" means planned individualized interventions intended to reduce or ameliorate mental illness, developmental disability, or substance abuse through care, treatment, training, habilitation, or other supports that are delivered by a provider to individuals with mental illness, developmental disability, or substance abuse. Services include residential services, including those for persons with brain injury.

"Severe weather" means extreme environment or climate conditions that pose a threat to the health, safety, or welfare of residents.

"Social skills training" means activities aimed at developing and maintaining interpersonal skills.

"Strategies" means a series of steps and methods used to meet goals and objectives.

"Strip search" means a visual inspection of the body of a resident when that resident's outer clothing or total clothing is removed and an inspection of the removed clothing. Strip searches are conducted for the detection of contraband.

"Structured program of care" means a comprehensive planned daily routine including appropriate supervision that meets the needs of each resident both individually and as a group.

"Student/intern" means an individual who simultaneously is affiliated with an educational institution and a residential facility. Every student/intern who is not an employee is either a volunteer or contractual service provider depending upon the relationship among the student/intern, educational institution, and facility.

"Substantial compliance" means that while there may be noncompliance with one or more regulations that represents minimal risk, compliance clearly and obviously exists with most of the regulations as a whole.

"Systemic deficiency" means violations documented by the department that demonstrate defects in the overall operation of the facility or one or more of its components.

"Target population" means individuals with a similar, specified characteristic or disability.

"Temporary contract worker" means an individual who is not a direct salaried employee of the provider but is employed by a third party and is not a consistently scheduled staff member.

"Therapy" means provision of direct diagnostic, preventive, and treatment services where functioning is threatened or affected by social and psychological stress or health impairment.

"Time out" means the involuntary removal of a resident by a staff person from a source of reinforcement to a different open location for a specified period of time or until the problem behavior has subsided to discontinue or reduce the frequency of problematic behavior.

"Treatment" means individually planned, sound, and therapeutic interventions that are intended to improve or maintain functioning of an individual receiving services in those areas that show impairment as the result of mental disability, substance addiction, or physical impairment. In order to be considered sound and therapeutic, the treatment must conform to current acceptable professional practice.

"Variance" means temporary or permanent waiver of compliance with a regulation or portion of a regulation, or permission to meet the intent of the regulation by a method other than that specified in the regulation, when the department, in its sole discretion, determines (i) enforcement will create an undue hardship and (ii) resident care will not be adversely affected.

"Volunteers" means any individual or group who of their own free will, and without any financial gain, provides goods and services to the program without compensation.

History

• Statutory Authority: §§ 37.2-302 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-46-20 Service description and applications; required elements

A. In order to determine whether an applicant is subject to this chapter, the applicant must submit a service description initially.

B. Each provider shall have a written service description that accurately describes its structured program of care and treatment consistent with the treatment, habilitation, or training needs of the residential population it serves. Service description elements shall include:

1. The mental health, substance abuse, developmental disability, or brain injury population the provider intends to serve;

2. The mental health, substance abuse, developmental disability, or brain injury interventions the provider will provide;

3. Provider goals;

4. Services provided; and

5. Contract services, if any.

C. The provider shall develop, implement, review, and revise its services according to the provider's mission and shall have that information available for public review.

D. Initial applications.

1. A completed application includes an initial application form; proposed working budget for the year showing projected revenue and expenses for the first year of operation and a balance sheet showing assets and liabilities; evidence of financial resources or a line of credit sufficient to cover estimated operating expenses for 90 days unless the facility is operated by a state or local government agency, board, or commission; a service description; a proposed staffing and supervision plan, including the staff information sheet; copies of all job descriptions; evidence of the applicant's authority to conduct business in Virginia; a copy of the floor plan with dimensions of rooms; a certificate of occupancy; current health inspection; evidence of consultation with state or local fire prevention authorities; and a list of board members, if applicable. This information shall be submitted to and approved by the department in order for the application to be considered complete.

2. All initial applications that are not complete within 12 months shall be closed.

3. Facilities operated by state or local government agencies, boards, and commissions shall submit a working budget showing appropriated revenue and projected expenses for the coming year.

4. Currently licensed providers shall demonstrate that they are operating in substantial compliance with applicable regulations before new facilities operated by the same provider will be licensed.

E. Renewal applications. A completed application for renewal of a facility's license shall be submitted within 30 days after being notified to submit a renewal application.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-30 The investigation

The department shall arrange and conduct an on-site inspection of the facility and a thorough review of the services and an investigation of the character, reputation, status, and responsibility of the applicant.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-40 Review of facilities

A. Representatives of the department shall make announced and unannounced reviews during the effective dates of the license. The purpose of these reviews is to monitor compliance with applicable regulations.

B. Representatives of the department shall notify relevant local governments and placing and funding agencies, including the Office of Comprehensive Services, of multiple health and safety or human rights violations in children's residential facilities when such violations result in the lowering of the license to provisional status.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-50 Posting of information

A. Information concerning the application for initial licensure of children's residential facilities shall be posted to the department's website by locality.

B. An accurate listing of all licensed facilities including information on renewal, denial, or provisional licensure, and services shall be posted on the department's website by locality.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-60 General requirements

A. The provider shall demonstrate substantial compliance with these regulations to demonstrate that its program and physical plant provide reasonably safe and adequate care while approved plans of action to correct findings of noncompliance are being implemented and there are no noncompliances that pose an immediate and direct danger to residents.

B. Corporations sponsoring residential facilities for children shall maintain their corporate status in accordance with Virginia law.

C. The provider shall comply with the terms of its license.

D. A license is not transferable and automatically expires when there is a change of ownership or sponsorship.

E. The current license shall be posted at all times in a place conspicuous to the public.

F. A license shall not be issued to a facility when noncompliance poses an immediate danger to a resident's life, health, or safety.

G. Intermediate sanctions authorized by statute may be imposed at the discretion of the department.

H. Each provider shall self-report to the department within 10 days lawsuits against or settlements with residential facility operators relating to the health and safety or human rights of residents and any criminal charges against staff that may have been made relating to the health and safety or human rights of residents.

I. The provider shall comply with all other applicable federal, state, or local laws and regulations.

J. The provider's current policy and procedure manual shall be readily accessible to all staff.

K. Providers shall not engage in willful action or gross negligence that jeopardizes the care or protection of residents.

L. Providers shall not engage in conduct or practices that are in violation of statutes related to abuse or neglect of children.

M. Providers shall not deviate significantly from the program or services for which a license was issued without obtaining prior written approval from the department.

N. Providers shall not make false statements on the application for licensure or misrepresent facts in the application process.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-70 Resident's rights

Each provider shall guarantee resident rights as outlined in § 37.2-400of the Code of Virginia and in the Rules and Regulations to Assure the Rights of Individuals Receiving Services from Providers Licensed, Funded, or Operated by the Department of Mental Health, Mental Retardation and Substance Abuse Services (12VAC35-115).

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-80 Written corrective action plans

A. If there is noncompliance with applicable regulations during an initial or ongoing review or investigation, the department shall issue a licensing report describing the noncompliance and requesting the provider to submit a corrective action plan.

B. The provider shall submit to the department and implement a written corrective action plan for each regulation for which the provider is found to be in noncompliance.

C. The corrective action plan shall include a:

1. Description of each corrective action to be taken to correct the noncompliance and to prevent reoccurrence in the future and the person responsible for implementation; and

2. Date of completion for each action.

D. The provider shall submit the corrective action plan to the department within 15 business days of the issuance of the licensing report. Extensions may be granted by the department when requested prior to the due date, but extensions shall not exceed an additional 10 business days. An immediate corrective action plan shall be required if the department determines that the violations pose a threat to the health, safety, or welfare of residents.

E. Upon receipt of the corrective action plan, the department shall review the plan and determine whether the plan is approved or not approved. The provider shall have an additional 10 business days to submit a revised corrective action plan after receiving a notice that the plan submitted has not been approved.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-90 Licenses

A. A conditional license shall be issued to a new provider that demonstrates compliance with administrative and policy requirements but has not demonstrated compliance with all of these regulations. A conditional license shall not exceed six months, but may be renewed, not to exceed 12 successive months for all conditional licenses and renewals combined.

B. A provisional license may be issued to a provider that has demonstrated an inability to maintain compliance with these regulations or other applicable regulations, has violations of licensing regulations that pose a threat to the health or safety of residents being served, or has two or more systemic deficiencies.

1. A provisional license may be issued at any time.

2. The term of a provisional license may not exceed six months unless allowed by the Code of Virginia.

3. A provisional license may be renewed, but a provisional license and any renewals shall not exceed 12 successive months for all provisional licenses and renewals combined.

C. An annual license:

1. Shall be issued when the provider applies for renewal while holding a conditional or provisional license or certificate and substantially meets or exceeds the requirements of these regulations and other regulations and statutes.

2. May be issued at any time if the provider has received one systemic deficiency.

3. May be renewed, but an annual license or certificate and any renewals thereof shall not exceed a period of 36 successive months for all annual licenses and renewals combined.

D. A triennial license shall be issued when the provider:

1. Applies for renewal while holding an annual or triennial license; and

2. Substantially meets or exceeds the requirements of these regulations and other applicable regulations and statutes.

E. The term of a facility's license may be modified at any time during the licensure period based on a change in the facility's compliance with these regulations and other applicable statutes and regulations.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-100 Application fees

A. There shall be a $500 nonrefundable initial application fee. If the application is closed, denied, or withdrawn all subsequent initial applications shall require another $500 fee.

B. There shall be a $100 nonrefundable renewal application fee.

C. A renewal fee shall not be charged to providers directly following the issuance of a conditional license.

D. The application fee shall not apply to state or local government-owned, operated, or contracted facilities.

E. Application fees shall be used for the development and delivery of training for providers and staff of children's residential facilities and regulators of these facilities.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-110 Modification

A. The conditions of a license may be modified during the term of the license with respect to the capacity, resident age range, facility location, resident gender, or changes in the services. Limited modifications may be approved during the conditional licensure period.

B. No change shall be implemented prior to approval by the department. The provider shall be notified in writing within 60 days following receipt of the request as to whether the modification is approved or a new license is required.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-120 Denial

A. An application for licensure may be denied when the applicant:

1. Violates any provision of applicable laws or regulations made pursuant to such laws;

2. Has a founded disposition of child abuse or neglect after the appeal process has been completed;

3. Has been convicted of a crime listed in § 37.2-416 or 63.2-1726 of the Code of Virginia;

4. Has made false statements on the application or misrepresentation of facts in the application process;

5. Has not demonstrated good character and reputation as determined through references, background investigations, driving records, and other application materials;

6. Has a history of adverse licensing actions or sanctions;

7. Permits, aids, or abets in the commission of an illegal act in services delivered by the provider; or

8. Engages in conduct or practices detrimental to the welfare of any individual receiving services from the provider.

B. If denial of a license is recom­mended, the facility shall be notified in writing of the deficiencies, the proposed action, the right to appeal, and the appeal process.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-130 Revocation

A. A license may be revoked when the provider:

1. Violates any provision of applicable laws or regulations;

2. Engages in conduct or practices that are in violation of statutes related to abuse or neglect of children;

3. Deviates significantly from the program or services for which a license was issued without obtaining prior written approval from the department or fails to correct such deviations within the specified time;

4. Permits, aids, or abets the commission of an illegal act in services delivered by the provider; or

5. Engages in conduct or practices detrimental to the welfare of any individual receiving services.

B. If revocation of a license is recommended, the facility shall be notified in writing of the deficiencies, the proposed action, the right to appeal, and the appeal process.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-140 Summary suspension

A. In conjunction with any proceeding for revocation, denial, or other action, when conditions or practices exist that pose an immediate and substantial threat to the health, safety, and welfare of the residents, the commissioner may issue an order of summary suspension of the license to operate a children's residential facility when he believes the operation of the facility should be suspended during the pendency of such proceeding.

B. Prior to the issuance of an order of summary suspension, the department shall contact the Executive Secretary of the Supreme Court of Virginia to obtain the name of a hearing officer. The department shall schedule the time, date, and location of the administrative hearing with the hearing officer.

C. The order of summary suspension shall take effect upon its issuance. It shall be delivered by personal service and certified mail, return receipt requested, to the address of record of the facility as soon as practicable. The order shall set forth:

1. The time, date, and location of the hearing;

2. The procedures for the hearing;

3. The hearing and appeal rights; and

4. Facts and evidence that formed the basis for the order of summary suspension.

D. The hearing shall take place within three business days of the issuance of the order of summary suspension.

E. The department shall have the burden of proving in any summary suspension hearing that it had reasonable grounds to require the facility to cease operations during the pendency of the concurrent revocation, denial, or other proceeding.

F. The administrative hearing officer shall provide written findings and conclusions, together with a recommendation as to whether the license should be summarily suspended, to the commissioner within five business days of the hearing.

G. The commissioner shall issue a final order of summary suspension or make a determination that the summary suspension is not warranted based on the facts presented and the recommendation of the hearing officer within seven business days of receiving the recommendation of the hearing officer.

H. The commissioner shall issue and serve on the children's residential facility or its designee by personal service or by certified mail, return receipt requested, either:

1. A final order of summary suspension including (i) the basis for accepting or rejecting the hearing officer's recommendations and (ii) notice that the children's residential facility may appeal the commissioner's decision to the appropriate circuit court no later than 10 days following issuance of the order; or

2. Notification that the summary suspension is not warranted by the facts and circumstances presented and that the order of summary suspension is rescinded.

I. The facility may appeal the commissioner's decision on the summary suspension to the appropriate circuit court no more than 10 days after issuance of the final order.

J. The outcome of concurrent revocation, denial, and other proceedings shall not be affected by the outcome of any hearing pertaining to the appropriateness of the order of summary suspension.

K. At the time of the issuance of the order of summary suspension, the department shall contact the appropriate agencies to inform them of the action and the need to develop relocation plans for residents, and ensure that parents and guardians are informed of the pending action.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-150 Variances

A. Any request for a variance shall be submitted in writing to the department and shall include:

1. Justification why enforcement of the regulation would create an undue hardship;

2. How the facility can comply with the intent of the regulation; and

3. Justification why resident care would not be adversely affected if the variance was granted.

B. A variance shall not be implemented prior to approval of the department.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-160 Investigation of complaints and allegations

The department is responsible for complete and prompt investigation of all complaints and allegations made against providers, and for notification of the appropriate persons or agencies when removal of residents may be necessary. Suspected criminal violations shall be reported to the appropriate law-enforcement authority.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

Part II Administration

12VAC35-46-170 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; repealed, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-180 Responsibilities of the provider

The provider shall develop and implement written policies and procedures to monitor and evaluate service quality and effectiveness on a systematic and ongoing basis. The provider shall implement improvements when indicated.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-190 Fiscal accountability

A. The provider shall maintain a system of financial recordkeeping that shows a separation of the provider's accounts from all other accounts.

B. The provider shall keep individual accounts separate. Providers shall not commingle funds of multiple individuals receiving services.

C. The provider shall identify in writing the title and qualifications of the person with designated authority and responsibility for the fiscal management of the provider's services.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-200 Insurance

A. The provider shall maintain liability insurance covering the premises and the facility's operations.

B. The provider shall provide documentation that all vehicles used to transport residents are insured, including vehicles owned by staff.

C. At a minimum, the person who has the authority and responsibility for fiscal management shall be bonded.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-210 Fundraising

The provider shall not use residents in its fundraising activities without written permission of the legal guardian and the permission of residents 14 years or older.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-220 Weapons

The provider shall develop and implement a written policy prohibiting firearms, pellet guns, air guns, or other weapons on the premises or at facility-sponsored activities unless the weapon is:

1. In the possession of licensed security personnel or a law-enforcement officer;

2. Kept securely under lock and key; or

3. Used by a resident with the legal guardian's permission under the supervision of a responsible adult in accordance with policies and procedures developed by the facility for the weapon's lawful and safe use.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-230 Relationship to the department

The provider shall submit or make available to the department such reports and information as the department may require to establish compliance with this chapter and other applicable regulations and statutes.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-240 Facilities serving persons over the age of 17 years

Facilities that are approved to serve persons over the age of 17 years shall comply with these regulations for all occupants regardless of age, except when it is determined by the department that housing, programs, services, and supervision for such persons are provided separately from those for the other residents.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-250 Health information

A. Health information required by this section shall be maintained for each staff member and for each individual who resides in a building occupied by residents, including each person who is not a staff member or resident of the facility. Health information shall be handled, maintained, and stored in a fashion that maintains confidentiality of the information at all times.

B. At the time of hire or residency at the facility, each individual shall submit the results of a tuberculosis screening assessment documenting the absence of tuberculosis in a communicable form as evidenced by the completion of a form containing, at a minimum, the elements of a current screening form published by the Virginia Department of Health. The screening assessment shall be no older than 30 days.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-260 Physical or mental health of personnel

A. The provider or the department may require a report of examination by a licensed physician or mental health professional when there are indications that an individual's physical, mental, or emotional health may jeopardize the care of residents.

B. An individual who is determined by a licensed physician or mental health professional to show an indication of a physical or mental condition that may jeopardize the safety of residents or that would prevent the performance of duties shall be removed immediately from contact with residents and food served to residents until the condition is cleared as evidenced by a signed statement from the physician or mental health professional.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-270 Qualifications

A. Regulations establishing minimum position qualifications shall be applicable to all providers. In lieu of the minimum position qualifications contained in this chapter, providers subject to (i) the rules and regulations of the Virginia Department of Human Resource Management or (ii) the rules and regulations of a local government personnel office may develop written minimum entry-level qualifications in accordance with the rules and regulations of the supervising personnel authority.

B. A person who assumes or is designated to assume the responsibilities of a position or any combination of positions described in this chapter shall:

1. Meet the qualifications of the position;

2. Fully comply with all applicable regulations for each function; and

3. Demonstrate a working knowledge of the policies and procedures that are applicable to the person's specific position.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-280 Job descriptions

There shall be a written job description for each position that, at a minimum, includes the:

1. Job title;

2. Duties and responsibilities; and

3. Minimum education, experience, knowledge, skills, and abilities required for entry.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-290 Written personnel policies and procedures

A. The provider shall have and implement provider approved written personnel policies and make its written personnel policies readily accessible to each staff member.

B. The provider shall develop and implement written policies and procedures to assure that persons employed in or designated to assume the responsibilities of each position possess the education, experience, knowledge, skills, and abilities specified in the job description for the position.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-300 Personnel records

A. Separate up-to-date personnel records shall be maintained for each employee, student or intern, volunteer, and contractual service provider for whom background investigations are required by Virginia statute. Content of personnel records of volunteers, students or interns, and contractual service providers may be limited to documentation of compliance with requirements of Virginia laws regarding child protective services and criminal history background investigations.

B. The records of each employee shall include:

1. A completed employment application form providing the individual's name, address, telephone number, and social security number or other unique identifier;

2. Educational background and employment history, including dates of employment for each position held and separation;

3. Professional references;

4. Reports of required health examinations;

5. Annual performance evaluations;

6. Documentation of compliance with requirements of Virginia laws regarding child protective services and criminal history background investigations;

7. Documentation of educational degrees or professional credentials, as applicable;

8. Documentation of all training required by this chapter and any other employee development received by individual staff; and

9. A current job description.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-310 Staff development

A. Required initial training.

1. Within seven days following their begin date, each staff member responsible for supervision of children shall receive basic orientation to the facility's behavior intervention policies, procedures, and techniques regarding less restrictive interventions, timeout, and physical restraint.

2. Within 14 days following an individual's begin date, and before an individual is alone supervising children, the provider shall conduct emergency preparedness and response training that shall include:

a. Alerting emergency personnel and sounding alarms;

b. Implementing evacuation procedures, including evacuation of residents with special needs (e.g., deaf, blind, nonambulatory);

c. Using, maintaining, and operating emergency equipment;

d. Accessing emergency information for residents, including medical information; and

e. Utilizing community support services.

3. Within 14 days following their begin date, new employees, employees transferring from other facilities operated by the same provider, relief staff, volunteers, and students and interns shall be given orientation and training regarding:

a. The objectives of the facility;

b. Practices of confidentiality;

c. The decision-making plan;

d. This chapter, including the prohibited actions as outlined in this chapter; and

e. Other policies and procedures that are applicable to the individual's positions, duties, and responsibilities.

4. Within 30 days following their begin date, all staff working with residents shall be enrolled in a standard first aid class and in a cardiopulmonary resuscitation class facilitated by the American Red Cross or other recognized authority, unless the individual is currently certified in first aid and cardiopulmonary resuscitation.

5. Within 30 days following their begin date, all staff working with residents shall be trained in child abuse and neglect, mandatory reporting, maintaining appropriate professional relationships and interaction among staff and residents, and suicide prevention.

6. Within 30 days following their begin date, all staff shall be trained on the facility's policies and procedures regarding standard precautions.

7. Within 30 days following their begin date, all staff shall be trained on appropriate siting of children's residential facilities and good neighbor policies and community relations.

8. Before administering medication, all staff responsible for medication administration shall have successfully completed a medication training program approved by the Board of Nursing or be licensed by the Commonwealth of Virginia to administer medications.

9. The provider shall carry out targeted staff training in any area of quality improvement as identified from the results of the quality improvement plan.

B. Required annual retraining.

1. All employees, contractors, students and interns, and volunteers shall complete an annual refresher emergency preparedness and response training that shall include:

a. Alerting emergency personnel and sounding alarms;

b. Implementing evacuation procedures, including evacuation of residents with special needs ( e.g., deaf, blind, nonambulatory);

c. Using, maintaining, and operating emergency equipment;

d. Accessing emergency information for residents, including medical information; and

e. Utilizing community support services.

2. All staff who administer medication shall complete annual refresher medication training.

3. All child care staff shall receive annual retraining on the provider's behavior supports and timeout policies and procedures.

4. All staff working with residents shall receive annual retraining in child abuse and neglect, mandatory reporting, maintaining appropriate professional relationships and interaction among staff and residents, and suicide prevention.

5. All staff shall receive annual retraining on the provider's policies and procedures regarding standard precautions.

C. Training provided shall be comprehensive and based on the needs of the population served to ensure that staff have the competencies to perform their jobs.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-320 Staff supervision

The provider shall develop and implement written policies and procedures regarding the supervision of employees, volunteers, contractors, and students/interns. These policies and procedures shall include:

1. Type of supervision;

2. Frequency of supervision; and

3. How the supervision will be documented.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-330 The applicant

As a condition of initial licensure and, if appropriate, license renewal, each applicant shall:

1. Provide documentation of training on appropriate siting of children's residential facilities and good neighbor policies and community relations;

2. Be interviewed in person by the department to determine the qualifications of the owner or operator as set out in this chapter; and

3. Provide evidence of relevant prior experience.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-340 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; repealed, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-350 Program director

A. The facility's program shall be directed by one or more qualified persons.

B. Persons directing programs shall be responsible for the development and implementation of the programs and services offered by the facility, including overseeing assessments, service planning, staff scheduling, and supervision.

C. Persons directing programs of a facility licensed to care for 13 or more residents shall be full-time, qualified staff members.

D. A person appointed after December 28, 2007, to direct programs shall have at least:

1. A master's degree in social work, psychology, counseling, or nursing and a combination of two years professional experience with children in a children's residential facility and in administration or supervision;

2. A baccalaureate degree in social work, psychology, counseling, or nursing and a combination of three years professional experience with children in a children's residential facility and in administration or supervision;

3. A baccalaureate degree and a combination of four years of professional experience with children in a children's residential facility and in administration or supervision; or

4. A license issued by the Commonwealth of Virginia as a drug or alcoholism counselor/worker if the facility's purpose is to treat drug abuse or alcoholism.

E. For services providing brain injury services, a person appointed to direct programs shall have a master's degree in psychology, or be a nurse licensed in Virginia, a rehabilitation professional licensed in Virginia, or a Certified Brain Injury Specialist with at least one year of clinical experience working with individuals with brain injury. Program directors who hold a bachelor's degree in the field of institutional management, social work, education, or other allied discipline shall have a minimum of two years of experience working with individuals with brain injury.

F. Any applicant for the program director position shall submit the following to demonstrate compliance with the qualifications required by this regulation for the program director:

1. Official transcripts from the accredited college or university of attendance within 30 days of hire; and

2. Documentation of prior relevant experience.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-360 Case manager

A. Case managers shall have the responsibility for coordination of all services offered to each resident.

B. Case managers shall have:

1. A master's degree in social work, psychology, or counseling;

2. A baccalaureate degree in social work or psychology with documented field work experience and shall be supervised by the program director or other staff employed by the provider with the same qualifications; or

3. A baccalaureate degree and three years of professional experience working with children.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-370 Child care supervisor

A. Child care supervisors shall have responsibility for the:

1. Development of the daily living program within each child care unit; and

2. Orientation, training, and supervision of direct care workers.

B. Child care supervisors shall have:

1. A baccalaureate degree in social work or psychology and two years of professional experience working with children one year of which must have been in a residential facility for children;

2. A high school diploma or a General Education Development Certificate (G.E.D.) and a minimum of five years professional experience working with children with at least two years in a residential facility for children; or

3. A combination of education and experience working with children as approved by the department.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-380 Child care staff

A. Each child care worker shall be responsible for guidance and supervision of the children to whom the child care worker is assigned.

B. Each child care worker and relief child care worker shall furnish evidence of having obtained one of the following experience or education standards:

1. A baccalaureate degree in human services;

2. An associate's degree and three months of experience working with children; or

3. A high school diploma or G.E.D. and six months of experience working with children.

C. A person with a high school diploma or G.E.D. and less than six months of experience working with children may be hired as child care staff, provided that the person does not work independently. Provisional child care staff shall at all times work directly with the program director, case manager, child care supervisor, or an experienced child care worker who has at least one year of professional experience working with children.

D. A person serving in a child care worker's position shall be at least 19 years of age, except as provided in 12VAC35-46-270 A.

E. The provider shall not be dependent on temporary contract workers to provide resident care.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-390 Relief staff

Qualified relief staff shall be employed as necessary to meet the needs of the programs and services offered and to maintain a structured program of care in accordance with these regulations.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-395 Additional requirements for residential facilities for individuals with brain injury

The provider of brain injury services shall employ or contract with a neuropsychologist or licensed clinical psychologist specializing in brain injury to assist, as appropriate, with initial assessments, development of individualized service plans, crises, staff training, and service design.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-400 Volunteers, students, and interns

The facility shall not be dependent upon volunteers, students, or interns to provide basic services.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-410 Support functions

A. Child care workers and other staff responsible for child care may assume the duties of nonchild care personnel only when these duties do not interfere with their child care responsibilities.

B. Residents shall not be solely responsible for support functions including, but not necessarily limited to, food service, maintenance of building and grounds, and housekeeping.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

Part III Residential Environment

12VAC35-46-420 Buildings, inspections, and building plans

A. All buildings and building-related equipment shall be inspected and approved by the local building official. Approval shall be documented by a certificate of occupancy.

B. The facility shall document at the time of its original application evidence of consultation with state or local fire prevention authorities.

C. The facility shall document annually after the initial application that buildings and equipment are maintained in accordance with the Virginia Statewide Fire Prevention Code (13VAC5-52).

D. At the time of the original application and at least annually thereafter, any location where the provider is responsible for serving food shall be inspected and approved by state or local health authorities regarding food service and general sanitation in accordance with Food Regulations (12VAC5-421).

E. The buildings and physical environment shall provide adequate space and shall be of a design that is suitable to house the programs and services provided and meet specialized needs of the residents.

F. Building plans and specifications for new construction, change in use of existing buildings, and any structural modifications or additions to existing buildings shall be submitted to and approved by the department and by other appropriate regulatory authorities.

G. Swimming pools shall be inspected by the state or local health authorities or by a swimming pool business.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-430 Heating systems, ventilation, and cooling systems

A. Heat shall be evenly distributed in all rooms occupied by the residents such that a temperature no less than 68°F is maintained, unless otherwise mandated by state or federal authorities.

B. Natural or mechanical ventilation to the outside shall be provided in all rooms used by residents.

C. Air conditioning or mechanical ventilating systems, such as electric fans, shall be provided in all rooms occupied by residents when the temperature in those rooms exceeds 80°F.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-440 Lighting

A. Artificial lighting shall be by electricity.

B. All areas within buildings shall be lighted for safety and the lighting shall be sufficient for the activities being performed.

C. Lighting in halls shall be adequate and shall be continuous at night.

D. Operable flashlights or battery-powered lanterns shall be available for each staff member on the premises between dusk and dawn to use in emergencies.

E. Outside entrances and parking areas shall be lighted for protection against injuries and intruders.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-450 Plumbing

A. Plumbing shall be maintained in good operational condition.

B. An adequate supply of hot and cold running water shall be available at all times.

C. Precautions shall be taken to prevent scalding from running water. Water temperatures shall be maintained between 100°F and 120°F.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-460 Toilet facilities

A. There shall be at least one toilet, one hand basin, and one shower or bathtub in each living unit.

B. There shall be at least one bathroom equipped with a bathtub in each facility.

C. There shall be at least one toilet, one hand basin, and one shower or tub for every eight residents for facilities licensed before July 1, 1981.

D. There shall be one toilet, one hand basin, and one shower or tub for every four residents in any building constructed or structurally modified after July 1, 1981, except secure custody facilities. Facilities licensed after December 28, 2007, shall comply with the one-to-four ratio.

E. The maximum number of staff members on duty in the living unit shall be counted in determining the required number of toilets and hand basins when a separate bathroom is not provided for staff.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-470 Personal necessities

A. An adequate supply of personal necessities shall be available to the residents at all times for purposes of personal hygiene and grooming.

B. Clean, individual washcloths and towels shall be in good repair and available once each week and more often if needed.

C. When residents are incontinent or not toilet trained, appropriate measures shall be taken for sanitation and to protect each individual's privacy, confidentiality, dignity, and health.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-480 Sleeping areas

A. When residents are four years of age or older, boys and girls shall have separate sleeping areas.

B. No more than four children shall share a bedroom or sleeping area.

C. Children who use wheelchairs, crutches, canes, or other mechanical devices for assistance in walking shall be provided with a planned, personalized means of effective egress for use in emergencies.

D. Beds shall be at least three feet apart at the head, foot, and sides and double-decker beds shall be at least five feet apart at the head, foot, and sides.

E. Sleeping quarters in facilities established, constructed, or structurally modified after July 1, 1981, shall have:

1. At least 80 square feet of floor area in a bedroom accommodating one person;

2. At least 60 square feet of floor area per person in rooms accommodating two or more persons; and

3. Ceilings with a primary height of at least 7-1/2 feet exclusive of protrusions, duct work, or dormers.

F. Each child shall have a separate, clean, comfortable bed equipped with a clean mattress, clean pillow, clean blankets, clean bed linens, and, if needed, a clean waterproof mattress cover.

G. Bed linens shall be changed at least every seven days and more often if needed.

H. Mattresses shall be fire retardant as evidenced by documentation from the manufacturer, except in buildings equipped with an automated sprinkler system as required by the Virginia Uniform Statewide Building Code (13VAC5-63).

I. Cribs shall be provided for residents under two years of age.

J. Each resident shall be assigned drawer space and closet space or equivalent that is accessible to the sleeping area for storage of clothing and personal belongings, except in secure custody facilities.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; Errata, 25:24 VA.R. 4356 August 3, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-490 Smoking prohibition

Smoking shall be prohibited in living areas and in areas where residents participate in programs.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-500 Residents' privacy

A. When bathrooms are not designated for individual use:

1. Each toilet shall be enclosed for privacy; and

2. Bathtubs and showers shall provide visual privacy for bathing by use of enclosures, curtains, or other appropriate means.

B. Windows in bathrooms, sleeping areas, and dressing areas shall provide for privacy.

C. Every sleeping area shall have a door that may be closed for privacy or quiet and this door shall be readily opened in case of fire or other emergency.

D. Residents shall be provided privacy from routine sight supervision by staff members of the opposite gender while bathing, dressing, or conducting toileting activities. This section does not apply to medical personnel performing medical procedures, staff providing assistance to infants, or staff providing assistance to residents whose physical or mental disabilities dictate the need for assistance with these activities as justified in the resident's record.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-510 Audio and visual recordings

Each provider shall have written policies and procedures regarding the photographing and audio or audio-video recordings of residents approved by the Office of Human Rights that shall ensure and provide that:

1. The written consent of the resident or the resident's legal guardian shall be obtained before the resident is photographed or recorded for research or provider publicity purposes.

2. No photographing or recording by provider staff shall take place without the resident or the resident's family or legal guardian being informed.

3. All photographs and recordings shall be used in a manner that respects the dignity and confidentiality of the resident.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-520 Living rooms and indoor recreation space

A. Each living unit shall have a living room, or other area for informal use, relaxation, and entertainment. The furnishings shall provide a comfortable, homelike environment that is appropriate to the ages of the residents.

B. All facilities shall have indoor recreation space that contains indoor recreation materials appropriate to the ages and interests of the residents.

C. Facilities licensed to care for 13 or more residents shall have indoor recreation space distinct from the living room. Recreation space is not required in every living unit.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-530 Study space

A. Facilities serving a school-age population shall provide study space. Study space may be assigned in areas used interchangeably for other purposes.

B. Study space shall be well lighted, quiet, and equipped with tables or desks and chairs.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-540 Kitchen and dining areas

A. Meals shall be served in areas equipped with sturdy tables and benches or chairs that are size and age appropriate for the residents.

B. Adequate kitchen facilities and equipment shall be provided for preparation and serving of meals.

C. Walk-in refrigerators, freezers, and other enclosures shall be equipped to permit emergency exits.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-550 Laundry areas

Appropriate space and equipment in good repair shall be provided if laundry is done at the facility.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-560 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; repealed, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-570 Staff quarters

A. A separate, private bedroom shall be provided for staff and their families when a staff member is on duty for 24 consecutive hours or more.

B. A separate private bathroom shall be provided for staff and their families when there are more than four persons in the living unit and the staff person is on duty for 24 consecutive hours or more.

C. Staff and members of their families shall not share bedrooms with residents.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-580 Office space

Space shall be provided for administrative activities including, as appropriate to the program, confidential conversations and provision for storage of records and materials.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-590 Buiding and grounds

A. The facility's grounds shall be safe, properly maintained, and free of clutter and rubbish. The grounds include, but are not limited to, all areas where residents, staff, and visitors may reasonably be expected to have access, including roads, pavements, parking lots, open areas, stairways, railings, and potentially hazardous or dangerous areas.

B. The interior and exterior of all buildings shall be safe, properly maintained, clean, and in good working order. This includes, but is not limited to, required locks, mechanical devices, indoor and outdoor equipment, and furnishings.

C. Outdoor recreation space shall be available and appropriately equipped for the residents' use.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-600 Equipment and furnishings

A. All furnishings and equipment shall be safe, clean, and suitable to the ages and number of residents.

B. There shall be at least one continuously operable, nonpay telephone accessible to staff in each building in which children sleep or participate in programs.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-610 Housekeeping and maintenance

A. All buildings shall be well ventilated and free of stale, musty, or foul odors.

B. Adequate provision shall be made for the collection and legal disposal of garbage and waste materials.

C. Buildings shall be kept free of flies, roaches, rats, and other vermin.

D. A sanitizing agent shall be used in the laundering of bed, bath, table, and kitchen linens.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-620 Farm and domestic animals

A. Horses and other animals maintained on the premises shall be quartered at a reasonable distance from sleeping, living, eating and food preparation areas, as well as a safe distance from water supplies.

B. Animals maintained on the premises shall be tested, inoculated, and licensed as required by law.

C. The premises shall be kept free of stray domestic animals.

D. Pets shall be provided with clean quarters and adequate food and water.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

Part IV Programs and Services

12VAC35-46-625 Minimum service requirements

A. The provider shall have and implement written policies and procedures for the on-site provision of a structured program of care or treatment of residents with mental illness, mental retardation, substance abuse, or brain injury. The provision, intensity, and frequency of mental health, mental retardation, substance abuse, or brain injury interventions shall be based on the assessed needs of the resident. These interventions, applicable to the population served, shall include, but are not limited to:

1. Individual counseling;

2. Group counseling;

3. Training in decision making, family and interpersonal skills, problem solving, self-care, social, and independent living skills;

4. Training in functional skills;

5. Assistance with activities of daily living (ADL's);

6. Social skills training in therapeutic recreational activities, e.g., anger management, leisure skills education and development, and community integration;

7. Providing positive behavior supports;

8. Physical, occupational, and/or speech therapy;

9. Substance abuse education and counseling; and

10. Neurobehavioral services for individuals with brain injury.

B. Each provider shall have formal arrangements for the evaluation, assessment, and treatment of the mental health or brain injury needs of the resident.

C. The provider shall have and implement written policies and procedures that address the provision of:

1. Psychiatric care;

2. Family therapy; and

3. Staffing appropriate to the needs and behaviors of the residents served.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-630 Acceptance of children

Children shall be accepted only by court order or by written placement agreement with legal guardians.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-640 Admission procedures

A. The facility shall have written criteria for admission that shall include:

1. A description of the population to be served;

2. A description of the types of services offered;

3. Intake and admission procedures;

4. Exclusion criteria to define those behaviors or problems that the facility does not have the staff with experience or training to manage; and

5. Description of how educational services will be provided to the population being served.

B. The facility shall accept and serve only those children whose needs are compatible with the services provided through the facility unless a child's admission is ordered by a court of competent jurisdiction.

C. Acceptance of a child as eligible for respite care by a facility approved to provide residential respite care is considered admission to the facility. Each individual period of respite care is not considered a separate admission.

D. Each facility shall provide documentation showing proof of contractual agreements or staff expertise to provide educational services, counseling services, psychological services, medical services, or any other services needed to serve the residents in accordance with the facility's program description as defined by the facility's criteria of admission.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-650 Least restrictive programming

Each resident shall be placed in the least restrictive level of programming appropriate to individual functioning and available services.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-660 Maintenance of resident records

A. The provider shall maintain a separate case record for each resident in accordance with § 32.1-127.1:03 of the Code of Virginia. In addition, all correspondence and documents received by the facility relating to the care of that resident shall be maintained as part of the case record. A separate health record may be kept on each resident.

B. Each record shall be kept up to date and in a uniform manner.

C. The provider shall develop and implement a written records management policy that describes confidentiality, accessibility, security, and retention of paper and electronic records pertaining to residents, including:

1. Access, duplication, dissemination, and acquisition of resident information only to persons legally authorized according to federal and state laws;

2. Storage, processing, and handling of active and closed records;

3. Security measures to protect records from loss, unauthorized alteration, inadvertent or unauthorized access, and disclosure of information during transportation of records between service sites;

4. Strategies for service continuity and record recovery from interruptions that result from disasters or emergencies, including contingency plans, electronic or manual back-up systems, and data retrieval systems; and

5. Disposition of records in the event the facility ceases to operate.

D. The policy shall specify what information is available to the resident.

E. Active and closed records shall be kept in areas that are accessible to authorized staff and protected from unauthorized access, fire, and flood.

F. Each resident's written record shall be stored separately subsequent to the resident's discharge according to applicable statutes and regulations.

G. Case records shall be retained in their entirety for a minimum of three years after the date of discharge unless otherwise specified by state or federal requirements.

H. Entries in a resident's record shall be current, dated, and authenticated by the person making the entry. Errors shall be corrected by striking through and initialing.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-670 Record reviews

Complete written policies and procedures for record reviews shall be developed and implemented that shall evaluate records for completeness, accuracy, and timeliness of documentation. Such policies shall include provisions for ongoing review to determine whether records contain all required service documentation, and release of information documents required by the provider.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-680 Interestate compact on the placement of children

A. Documentation of the prior approval of the administrator of the Virginia Interstate Compact on the Placement of Children, Virginia Department of Social Services, shall be retained in the record of each resident admitted from outside Virginia. The requirements of this section shall not apply to a facility providing documentation that the administrator of the Virginia Interstate Compact has determined the facility is statutorily exempt from the compact's provisions.

B. Documentation that the provider has sent copies of all serious incident reports regarding any child placed through the Interstate Compact to the administrator of the Virginia Interstate Compact on the Placement of Children shall be kept in the resident's record.

C. No later than five days after a resident has been transferred to another facility operated by the same sponsor, the resident's record shall contain documentation that the administrator of the Virginia Interstate Compact on the Placement of Children was notified in writing of the resident's transfer.

D. No later than 10 days after discharge, the resident's record shall contain documentation that the adminis­trator of the Virginia Interstate Compact on the Placement of Children was notified in writing of the discharge.

E. The provider shall not discharge or send out-of-state youth in the custody of out-of-state social services agencies and courts to reside with a parent, relative, or other individual who lives in Virginia without the approval of the administrator of the Virginia Interstate Compact on the Placement of Children.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-690 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; repealed, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-700 Emergency and self-admissions

Providers accepting emergency or self-admissions shall:

1. Develop and implement written policies and procedures governing such admissions that shall include procedures to make and document prompt efforts to obtain (i) a written placement agreement signed by the legal guardian or (ii) the order of a court of competent jurisdiction;

2. Place in each resident's record the order of a court of competent jurisdiction, a written request for care, or documentation of an oral request for care; and justification of why the resident is to be admitted on an emergency basis; and

3. Clearly document in written assessment information gathered for the emergency admission that the individual meets the facility's criteria for admission.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-710 Application for admission

A. Admission shall be based on evaluation of a screening application for admission. The requirements of this section do not apply to court-ordered placements or transfer of a resident between residential facilities located in Virginia and operated by the same sponsor.

B. Providers shall develop and fully complete prior to acceptance for care an application for admission that is designed to compile screening information necessary to determine:

1. The educational needs of the prospective resident;

2. The mental health, emotional, and psychological needs of the prospective resident;

3. The physical health needs, including the immunization needs, of the prospective resident;

4. The protection needs of the prospective resident;

5. The suitability of the prospective resident's admission;

6. The behavior support needs of the prospective resident;

7. Family history and relationships;

8. Social and development history;

9. Current behavioral functioning and social competence;

10. History of previous treatment for mental health, developmental disability, substance abuse, brain injury, and behavior problems; and

11. Medication and drug use profile, which shall include:

a. History of prescription, nonprescription, and illicit drugs taken over the six months prior to admission;

b. Drug allergies, unusual and other adverse drug reactions, and ineffective medications; and

c. Information necessary to develop an individualized service plan and a behavior support plan.

C. The resident's record shall contain a completed assessment based on information compiled from the screening application at the time of a routine admission or within 30 days after an emergency admission.

D. Each facility shall develop and implement written policies and procedures to assess each prospective resident as part of the application process to ensure that:

1. The needs of the prospective resident can be addressed by the facility's services;

2. The facility's staff is trained to meet the prospective resident's needs; and

3. The admission of the prospective resident would not pose any significant risk to (i) the prospective resident or (ii) the facility's residents or staff.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-720 Written placement agreement

A. The facility shall develop and execute a written agreement authorizing the resident's placement, signed by a facility representative and the parent, legal guardian, or placing agency.

B. Notwithstanding the provisions of subsection A of this section, a facility that accepts an admission upon receipt of the order of a court of competent jurisdiction shall place a copy of the court order in the resident’s record.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-730 Face sheet

A. At the time of admission, each resident's record shall include a completed face sheet that contains (i) the resident's full name, last known residence, birth date, birthplace, gender, race, social security number or other unique identifier, religious preference, and admission date; and (ii) names, addresses, and telephone numbers of the resident's legal guardians, placing agency, emergency contacts, and parents, if appropriate.

B. The provider shall update information when changes occur.

C. The face sheet for pregnant teens shall also include the expected date of delivery and the name of the hospital to provide delivery services to the resident.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-740 Initial objectives and strategies

Within three days following admission, individualized, measurable objectives and strategies for the first 30 days shall be developed, distributed to affected staff and the resident, and placed in the resident's record.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-750 Individualized service plans and quarterly reports

A. An individualized service plan shall be developed and placed in the resident's record within 30 days following admission and implemented immediately thereafter.

B. Individualized service plans shall describe in measurable terms the:

1. Strengths and needs of the resident;

2. Resident's current level of functioning;

3. Goals, objectives, and strategies established for the resident;

4. Projected family involvement;

5. Projected date for accomplishing each objective; and

6. Status of the projected discharge plan and estimated length of stay, except that this requirement shall not apply to a facility that discharges only upon receipt of the order of a court of competent jurisdiction.

C. The provider shall develop and implement written policies and procedures to document progress of the resident toward meeting the ISP goals and objectives that shall include the:

1. Format;

2. Frequency; and

3. Person responsible.

D. There shall be a documented quarterly review of each resident's progress 60 days following the initial individualized service plan and within each 90-day period thereafter that shall report the:

1. Resident's progress toward meeting the plan's objectives;

2. Family's involvement;

3. Continuing needs of the resident;

4. Resident's progress toward discharge; and

5. Status of discharge planning.

E. Each ISP revision and quarterly progress report shall include the date it was developed and the signature of the person responsible.

F. Staff responsible for daily implementation of the resident's individualized service plan shall be able to describe the resident's behavior in terms of the objectives in the current ISP.

G. In developing and updating the ISP and in developing the quarterly progress report, the provider shall document the involvement of the following parties unless clearly inappropriate:

1. The resident;

2. The resident's family, if appropriate, and legal guardian;

3. The placing agency; and

4. Facility staff.

H. The initial individualized service plan, each update, and all quarterly progress reports shall be distributed to the resident; the resident's family, if appropriate, legal guardian, or authorized representative; the placing agency; and appropriate facility staff.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-760 Resident transfer between residential facilities located in Virginia and operated by the same sponsor

A. Except when transfer is ordered by a court of competent jurisdiction, the provider's receiving service or facility shall document receipt of the following at the time of the resident's transfer:

1. Documentation of advance notification to the family, if appropriate, the resident, the placement agency, and the legal guardian;

2. A written summary of the resident's progress while at the transferring facility, justification for the transfer, and the resident's current strengths and needs; and

3. A copy of the resident's record.

B. The transferring service or facility shall document the date of transfer and the name of the receiving service or facility to which the resident was transferred.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-765 Discharge

A. The provider shall have written criteria for discharge that shall include:

1. Criteria for a resident's completing the program that are consistent with the facility's programs and services;

2. Conditions under which a resident may be discharged before completing the program; and

3. Procedures for assisting placing agencies in placing the residents should the facility cease operation.

B. The provider's criteria for discharge shall be accessible to prospective residents, legal guardians, and placing agencies.

C. The record of each resident discharged upon receipt of the order of a court of competent jurisdiction shall contain a copy of the court order.

D. Residents shall be discharged only to the legal guardian or legally authorized representative.

E. A facility approved to provide residential respite care shall discharge a resident when the legal guardian no longer intends to use the facility's services.

F. Information concerning current medications, need for continuing therapeutic interventions, educational status, and other items important to the resident's continuing care shall be provided to the legal guardian or legally authorized representative, as appropriate.

G. Unless discharge is ordered by a court of competent jurisdiction prior to the planned discharge date, each resident's record shall contain:

1. Documentation that discharge has been planned and discussed with the parent, if appropriate; legal guardian; child-placing agency; and resident; and

2. A written discharge plan.

H. Discharge summaries.

1. No later than 30 days after discharge, a comprehensive discharge summary shall be placed in the resident's record and sent to the persons or agency that made the placement. The discharge summary shall review:

a. Services provided to the resident;

b. The resident's progress toward meeting individualized service plan objectives;

c. The resident's continuing needs and recommendations, if any, for further services and care;

d. Reasons for discharge and names of persons to whom the resident was discharged;

e. Dates of admission and discharge; and

f. Date the discharge summary was prepared and the signature of the person preparing it.

2. In lieu of a comprehensive discharge summary, the record of each resident discharged upon receipt of the order of a court of competent jurisdiction shall contain a copy of the court order.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-770 Placement of residents outside the facility

A resident shall not be placed outside the facility prior to the facility obtaining a child-placing agency license from the Department of Social Services, except as permitted by statute or by order of a court of competent jurisdiction.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-780 Case management services

A. The program of the facility shall be designed to provide case management services. At the time of the admission of any resident, the provider shall identify in writing the staff member responsible for providing case management services. Case management services shall address:

1. Helping the resident and the parents or legal guardian to understand the effects on the resident of separation from the family and the effect of group living;

2. Assisting the resident and the family to maintain their relationships and prepare for the resident's future care;

3. Utilizing appropriate community resources to provide services and maintain contacts with such resources;

4. Helping the resident strengthen his capacity to function productively in interpersonal relationships;

5. Conferring with the child care staff to help them understand the resident's needs in order to promote adjustment to group living; and

6. Working with the resident and with the family or any placing agency that may be involved in planning for the resident's future and in preparing the resident for the return home or to another family for independent living or for other residential care.

B. The provision of case management services shall be documented in each resident's record.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-790 Therapy

Therapy shall be provided by an individual (i) appropriately licensed by the Department of Health Professions to provide mental health therapy or counseling; or (ii) who is eligible for licensure and working under the supervision of a licensed therapist unless exempted from these requirements under the Code of Virginia.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-800 Structured program of care

A. There shall be evidence of a structured program of care designed to:

1. Meet each resident's physical and emotional needs;

2. Provide protection, guidance, and supervision; and

3. Meet the objectives of any required individualized service plan.

B. There shall be evidence of a structured daily routine designed to ensure the delivery of program services.

C. The provider shall maintain a daily communication log to share information with staff about significant happenings or problems experienced by residents, with the identity of the person making each entry in the log recorded.

D. Health and dental complaints and injuries shall be recorded and shall include the (i) resident's name, complaint, and affected area and (ii) time of the complaint.

E. Routines shall be planned to ensure that each resident receives the amount of sleep and rest appropriate for the resident's age and physical condition.

F. Staff shall promote good personal hygiene of residents by monitoring and supervising hygiene practices each day and by providing instruction when needed.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-810 Health care procedures

A. The provider shall implement written procedures for promptly:

1. Providing or arranging for the provision of medical and dental services for health problems identified at admission;

2. Providing or arranging for the provision of routine ongoing and follow-up medical and dental services after admission;

3. Providing emergency services for each resident; and

4. Providing emergency services for any resident in crisis, including procedures for crisis or clinical stabilization and immediate access to appropriate internal and external resources, including a provision for obtaining physician and mental health clinical services.

B. The following written information concerning each resident shall be readily accessible to staff who may have to respond to a medical or dental emergency:

1. Name, address, and telephone number of the physician and dentist to be notified;

2. Name, address, and telephone number of a relative or other person to be notified;

3. Medical insurance company name and policy number or Medicaid number;

4. Information concerning:

a. Use of medication;

b. All allergies, including medication allergies;

c. Substance abuse and use; and

d. Significant past and present medical problems; and

5. Written permission for emergency medical care, dental care, and obtaining immunizations or a procedure and contacts for obtaining consent.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-820 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; repealed, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-830 Documenting crisis intervention and clinical emergency services

A. The provider shall develop and implement a method for documenting the provision of crisis intervention and clinical emergency services. Documentation shall include:

1. Date and time;

2. Nature of crisis or emergency;

3. Name of resident;

4. Precipitating factors;

5. Interventions or treatment provided;

6. Employees or contractors involved;

7. Outcome; and

8. Any required follow-up.

B. If a crisis or clinical emergency involves a resident who receives medical or mental health services, the crisis intervention documentation shall become part of the resident's record.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-840 Medical examinations and treatment

A. Each child accepted for care shall have a physical examination by or under the direction of a licensed physician no earlier than 90 days prior to admission to the facility or no later than seven days following admission, except (i) the report of an examination within the preceding 12 months shall be acceptable if a child transfers from one residential facility licensed or certified by a state agency to another; and (ii) a physical examination shall be conducted within 30 days following an emergency admission if a report of physical examination is not available.

B. Within seven days of placement, each resident shall have had a screening assessment for tuberculosis as evidenced by the completion of a screening form containing, at a minimum, the elements found on the Report of Tuberculosis Screening form published by the Virginia Department of Health. The screening assessment may be no older than 30 days.

C. A screening assessment for tuberculosis shall be completed annually on each resident as evidenced by the completion of a form containing, at a minimum, the elements of the Report of Tuberculosis Screening form published by the Virginia Department of Health.

D. Each resident's health record shall include written documentation of (i) the initial physical examination; (ii) an annual physical examination by or under the direction of a licensed physician, including any recommendation for follow-up care; and (iii) documentation of the provision of follow-up medical care recommended by the physician or as indicated by the needs of the resident.

E. Each physical examination report shall include:

1. Information necessary to determine the health and immunization needs of the resident, including:

a. Immunizations administered at the time of the exam;

b. Vision exam;

c. Hearing exam;

d. General physical condition, including documentation of apparent freedom from communicable disease, including tuberculosis;

e. Allergies, chronic conditions, and handicaps, if any;

f. Nutritional requirements, including special diets, if any;

g. Restrictions on physical activities, if any; and

h. Recommendations for further treatment, immunizations, and other examinations indicated;

2. Date of the physical examination; and

3. Signature of a licensed physician, the physician's designee, or an official of a local health department.

F. A child with a communicable disease shall not be admitted unless a licensed physician certifies that:

1. The facility is capable of providing care to the child without jeopardizing residents and staff; and

2. The facility is aware of the required treatment for the child and the procedures to protect residents and staff.

G. Each resident's health record shall include written documentation of (i) an annual examination by a licensed dentist and (ii) follow-up dental care recommended by the dentist or as indicated by the needs of the resident. This requirement does not apply to respite care facilities.

H. Each resident's health record shall include notations of health and dental complaints and injuries and shall summarize symptoms and treatment given.

I. Each resident's health record shall include or document the facility's efforts to obtain treatment summaries of ongoing psychiatric or other mental health treatment and reports.

J. The provider shall develop and implement written policies and procedures that include use of standard precautions and address communicable and contagious medical conditions. These policies and procedures shall be approved by a medical professional.

K. A well-stocked first aid kit shall be maintained and readily accessible for minor injuries and medical emergencies.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-850 Medication

A. The provider shall develop and implement written policies and procedures regarding the delivery and administration of prescription and nonprescription medications used by residents. At a minimum these policies will address:

1. Identification of the staff member responsible for routinely communicating to the prescribing physician;

2. Storage of controlled substances;

3. Documentation of medication errors and drug reactions;

4. Documentation of any medications prescribed and administered following admission;

5. Disposal of medication; and

6. Distribution of medication off campus.

B. All medication shall be securely locked and properly labeled.

C. Policies shall include training requirements necessary for employees or contractors who are authorized to administer medications. Medications shall be administered only by persons authorized to do so by the Drug Control Act (§ 54.1-3400 et seq. of the Code of Virginia).

D. Staff authorized to administer medication shall be informed of any known side effects of the medication and the symptoms of the side effects.

E. A program of medication, including over-the-counter medication, shall be initiated for a resident only when prescribed in writing by a person authorized by law to prescribe medication.

F. Medication prescribed by a person authorized by law shall be administered as prescribed.

G. A medication administration record shall be maintained of all medicines received by each resident and shall include:

1. Date the medication was prescribed;

2. Drug name;

3. Schedule for administration;

4. Strength;

5. Route;

6. Identity of the individual who administered the medication; and

7. Dates the medication was discontinued or changed.

H. In the event of a medication error or an adverse drug reaction, first aid shall be administered if indicated. Staff shall promptly contact a poison control center, pharmacist, nurse, or physician and shall take actions as directed. If the situation is not addressed in standing orders, the attending physician shall be notified as soon as possible and the actions taken by staff shall be documented.

I. Medication refusals shall be documented including action taken by staff.

J. The telephone number of a regional poison control center and other emergency numbers shall be posted on or next to each non-pay telephone that has access to an outside line in each building in which children sleep or participate in programs.

K. Syringes and other medical implements used for injecting or cutting skin shall be locked.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-860 Nutrition

A. Each resident shall be provided a daily diet that (i) consists of at least three nutritionally balanced meals and an evening snack; (ii) includes an adequate variety and quantity of food for the age of the resident; and (iii) meets minimum nutritional requirements and the U.S. Department of Health and Human Services and U.S. Department of Agriculture Dietary Guidelines for Americans, 2005, 6th Edition.

B. Special diets shall be provided when prescribed by a physician and the established religious dietary practices of the residents shall be observed.

C. Staff who eat in the presence of the residents shall be served the same meals as the residents unless (i) a special diet has been prescribed by a physician for the staff or residents or (ii) the staff or residents are observing established religious dietary practices.

D. There shall be no more than 15 hours between the evening meal and breakfast the following day.

E. Providers shall ensure that food is available to residents who need to eat breakfast before the 15 hours have expired.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-870 Staff supervision of residents

A. No member of the child care staff shall be on duty more than six consecutive days without a rest day, except in an emergency or as approved by the department for live-in staff.

B. Child care staff shall have an average of at least two rest days per week in any four-week period. Rest days shall be in addition to vacation time and holidays.

C. Child care staff other than live-in staff shall not be on duty more than 16 consecutive hours, except in an emergency.

D. There shall be at least one trained child care worker on duty and actively supervising residents at all times that one or more residents are present.

E. Whenever children are being supervised by staff there shall be at least one staff person present with a current basic certificate in standard first aid and a current certificate in cardiopulmonary resuscitation issued by the American Red Cross or other recognized authority.

F. Supervision policies.

1. The provider shall develop and implement written policies and procedures that address staff supervision of children including contingency plans for resident illnesses, emergencies, off-campus activities, and resident preferences. These policies and procedures shall be based on the:

a. Needs of the population served;

b. Types of services offered;

c. Qualifications of staff on duty; and

d. Number of residents served.

2. At all times the ratio of staff to residents shall be at least one staff to eight residents for facilities during the hours residents are awake, except when the department has approved or required a supervision plan with a different ratio based on the needs of the population served.

3. Providers requesting a ratio that allows a higher number of residents to be supervised by one staff person than was approved or required shall submit a justification to the department that shall include:

a. Why resident care will not be adversely affected; and

b. How residents' needs will be met on an individual as well as group basis.

4. Written policies and procedures governing supervision of residents and any justifications for a ratio deviation that allows a higher number of residents to be supervised by one staff than was approved or required shall be reviewed and approved by the department prior to implementation.

5. The supervision policies or a summary of the policies shall be provided, upon request, to the placing agency or legal guardian prior to placement.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-880 Emergency telephone numbers

There shall be an emergency telephone number where a staff person may be immediately contacted 24 hours a day.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-890 Searches

A. Strip searches and body cavity searches are prohibited.

B. A provider that conducts pat downs shall develop and implement written policies and procedures governing the use of pat downs providing that:

1. Pat downs shall be limited to instances where necessary to prohibit contraband;

2. Pat downs shall be conducted by personnel of the same gender as the resident being searched;

3. Pat downs shall be conducted only by personnel who are specifically trained and authorized to conduct searches by the written policies and procedures; and

4. Pat downs shall be conducted in such a way as to protect the resident's dignity in accordance with 12VAC35-115 and in the presence of one or more witnesses.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-900 Behavior support

A. Within 30 days of admission, the provider shall develop and implement a written behavior support plan that allows the resident to self-manage his own behaviors. Each individualized behavior support plan shall include:

1. Identification of positive and problem behavior;

2. Identification of triggers for behaviors;

3. Identification of successful intervention strategies for problem behavior;

4. Techniques for managing anger and anxiety; and

5. Identification of interventions that may escalate inappropriate behaviors.

B. Individualized behavior support plans shall be developed in consultation with the:

1. Resident;

2. Legal guardian;

3. Resident's parents, if appropriate;

4. Program director;

5. Placing agency staff; and

6. Other appropriate individuals.

C. Prior to working alone with an assigned resident, each staff member shall demonstrate knowledge and understanding of that resident's behavior support plan.

D. Each provider shall develop and implement written policies and procedures concerning behavior support plans and other behavioral interventions that are directed toward maximizing the growth and development of the resident consistent with the requirements of 12VAC35-115-105.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-910 Timeout

A. The provider shall develop and implement written policies and procedures governing the conditions under which a resident may be placed in timeout and the maximum period of timeout. The conditions and maximum period of timeout shall be based on the resident's chronological and developmental level.

B. The area in which a resident is placed shall not be locked nor the door secured in a manner that prevents the resident from opening it.

C. A resident in timeout shall be able to communicate with staff.

D. Staff shall check on the resident in the timeout area at least every 15 minutes and more often depending on the nature of the resident's disability, condition, and behavior.

E. Use of timeout and staff checks on the residents shall be documented.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-920 Prohibitions

The following actions are prohibited:

1. Deprivation of drinking water or food necessary to meet a resident's daily nutritional needs, except as ordered by a licensed physician for a legitimate medical purpose and documented in the resident's record;

2. Limitation on contacts and visits with the resident's attorney, a probation officer, regulators, or placing agency representative;

3. Bans on contacts and visits with family or legal guardians, except as permitted by other applicable state regulations or by order of a court of competent jurisdiction;

4. Delay or withholding of incoming or outgoing mail, except as permitted by other applicable state and federal regulations or by order of a court of competent jurisdiction;

5. Any action that is humiliating, degrading, or abusive;

6. Corporal punishment;

7. Subjection to unsanitary living conditions;

8. Deprivation of opportunities for bathing or access to toilet facilities, except as ordered by a licensed physician for a legitimate medical purpose and documented in the resident's record;

9. Deprivation of health care;

10. Deprivation of appropriate services and treatment;

11. Application of aversive stimuli, except as permitted pursuant to other applicable state regulations;

12. Administration of laxatives, enemas, or emetics, except as ordered by a licensed physician or poison control center for a legitimate medical purpose and documented in the resident's record;

13. Deprivation of opportunities for sleep or rest, except as ordered by a licensed physician for a legitimate medical purpose and documented in the resident's record; and

14. Limitation on contacts and visits with advocates employed by the department or the Virginia Office for Protection and Advocacy.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-930 Pharmacological or mechanical restraints

A. Use of mechanical restraints is prohibited except as permitted by other applicable state regulations or as ordered by a court of competent jurisdiction.

B. Use of pharmacological restraints is prohibited.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-940 Behavior interventions

A. The provider shall develop and implement written policies and procedures for behavioral interventions consistent with the requirements of 12VAC35-115. Minimum provisions shall include rules of conduct and methods for documenting and monitoring the management of resident behavior.

B. Written information concerning the provider's behavioral support and intervention policies and procedures shall be provided prior to admission to prospective residents, legal guardians, and placing agencies. For court-ordered and emergency admissions, this information shall be provided to:

1. Residents within 12 hours following admission;

2. Placing agencies within 72 hours following the resident's admission; and

3. Legal guardians within 72 hours following the resident's admission. The requirements of this subsection do not apply when a state psychiatric hospital is evaluating a child's treatment needs as provided by the Code of Virginia.

C. When substantive revisions are made to policies and procedures governing management of resident behavior, written information concerning the revisions shall be provided to:

1. Residents prior to implementation; and

2. Legal guardians and placing agencies prior to implementation, except when a state psychiatric hospital is evaluating a child's treatment needs as provided by the Code of Virginia.

D. The provider shall develop and implement written policies and procedures governing use of physical restraint that shall comply with the requirements of 12VAC35-115.

E. All physical restraints shall be reviewed and evaluated to plan for continued staff development for performance improvement.

F. Use of physical restraint shall be limited to that which is minimally necessary to protect the resident or others as required by 12VAC35-115.

G. Trained staff members may physically restrain a resident only after less restrictive interventions.

H. Only trained staff members may manage resident behavior.

I. Each application of physical restraint shall be fully documented in the resident's record, including:

1. Date;

2. Time;

3. Staff involved;

4. Justification for the restraint;

5. Less restrictive interventions that were unsuccessfully attempted prior to using physical restraint;

6. Duration;

7. Description of methods of physical restraint techniques used;

8. Signature of the person completing the report and date; and

9. Reviewer's signature and date.

J. Providers shall ensure that restraint may only be implemented, monitored, and discontinued by staff who have been trained in the proper and safe use of restraint, including hands-on techniques.

K. The provider shall review the facility's behavior intervention techniques and policies and procedures at least annually to determine appropriateness for the population served.

L. Any time children are present, staff shall be present who have completed all trainings in behavior intervention.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-950 Seclusion

Seclusion is allowed only as permitted by 12VAC35-115 and other applicable state regulations.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-960 Seclusion room requirements

A. The room used for seclusion shall meet the design requirements for buildings used for detention or seclusion of persons.

B. The seclusion room shall be at least six feet wide and six feet long with a minimum ceiling height of eight feet.

C. The seclusion room shall be free of all protrusions, sharp corners, hardware, fixtures, or other devices, that may cause injury to the occupant.

D. Windows in the seclusion room shall be constructed to minimize breakage and otherwise prevent the occupant from harming himself.

E. Light fixtures and other electrical receptacles in the seclusion room shall be recessed or so constructed as to prevent the occupant from harming himself. Light controls shall be located outside the seclusion room.

F. Doors to the seclusion room shall be at least 32 inches wide, shall open outward and shall contain observation view panels of transparent wire glass or its approved equivalent, not exceeding 120 square inches but of sufficient size for someone outside the door to see into all corners of the room.

G. The seclusion room shall contain only a mattress with a washable mattress covering designed to avoid damage by tearing.

H. The seclusion room shall maintain temperatures appropriate for the season.

I. All space in the seclusion room shall be visible through the locked door, either directly or by mirrors.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-970 Education

A. Each resident of compulsory school attendance age shall be enrolled, as provided in the Code of Virginia, in an appropriate educational program within five school business days. Documentation of the enrollment shall be kept in the resident's record.

B. The provider shall ensure that educational guidance and counseling in selecting courses is provided for each resident and shall ensure that education is an integral part of the resident's total program.

C. Providers operating educational programs for children with disabilities shall operate those programs in compliance with applicable state and federal statutes and regulations.

D. When a child with a disability has been placed in a residential facility, the facility shall contact the division superintendent of the resident's home locality. Documentation of the contact with the resident's home school shall be kept in the resident's record.

E. A provider that has an academic or vocational program that is not certified or approved by the Department of Education shall document that teachers meet the qualifications to teach the same subjects in the public schools.

F. Each provider shall develop and implement written policies and procedures to ensure that each resident has adequate study time.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-980 Religion

A. The provider shall have and implement written policies regarding opportunities for residents to participate in religious activities.

B. The provider's policies on religious participation shall be available to residents and any individual or agency considering placement of a child in the facility.

C. Residents shall not be coerced to participate in religious activities.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-990 Recreation

A. The provider shall have a written description of its recreation program that describes activities that are consistent with the facility's total program and with the ages, developmental levels, interests, and needs of the residents that includes:

1. Opportunities for individual and group activities;

2. Free time for residents to pursue personal interests that shall be in addition to a formal recreation program, except that this subdivision does not apply to secure custody facilities;

3. Use of available community recreational resources and facilities, except that this subdivision does not apply to secure custody facilities;

4. Scheduling of activities so that the activities do not conflict with meals, religious services, educational programs, or other regular events; and

5. Regularly scheduled indoor and outdoor recreational activities that are structured to develop skills and attitudes.

B. The provider shall develop and implement written policies and procedures to ensure the safety of residents participating in recreational activities that include:

1. How activities will be directed and supervised by individuals knowledgeable in the safeguards required for the activities; and

2. How safeguards for water-related activities will be provided, including ensuring that a certified lifeguard supervises all swimming activities.

C. For all overnight recreational trips away from the facility, the provider shall document trip planning, to include:

1. A supervision plan for the entire duration of the activity, including awake and sleeping hours;

2. A plan for safekeeping and distribution of medication;

3. An overall emergency, safety, and communication plan for the activity, including emergency numbers of facility administration;

4. Staff training and experience requirements for each activity;

5. A plan to evaluate each resident's physical health throughout the activity and to ensure that the activity is conducted within the boundaries of the resident's capabilities, dignity, and respect for self-determination; and

6. Documentation of any variations from trip plans and reason for the variation.

D. All overnight out-of-state or out-of-country recreational trips require written permission from each resident's legal guardian.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-1000 Community relationships

A. Opportunities shall be provided for the residents to participate in activities and to utilize resources in the community.

B. The provider shall develop and implement written policies and procedures for evaluating persons or organizations in the community who wish to associate with residents on the premises or take residents off the premises. The procedures shall cover how the facility will determine if participation in such community activities or programs would be in the residents' best interest.

C. Each facility shall have a staff community liaison who shall be responsible for facilitating cooperative relationships with neighbors, the school system, local law enforcement, local government officials, and the community at large.

D. Each provider shall develop and implement written policies and procedures for promoting positive relationships with the neighbors that shall be approved by the department.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-1010 Clothing

A. Provision shall be made for each resident to have an adequate supply of clean, comfortable, and well-fitting clothes and shoes for indoor and outdoor wear.

B. Residents shall have the opportunity to participate in the selection of their clothing, except that this requirement does not apply to secure custody facilities.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-1020 Allowances and spending money

A. The provider shall develop and implement written policies for safekeeping and for recordkeeping of any money that belongs to residents.

B. A resident's funds, including any allowance or earnings, shall be used for the resident's benefit.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-1030 Work and employment

A. Assignment of chores, that are paid or unpaid work assignments, shall be in accordance with the age, health, ability, and service plan of the resident.

B. Chores shall not interfere with school programs, study periods, meals, or sleep.

C. Work assignments or employment outside the facility, including reasonable rates of pay, shall be approved by the program director with the knowledge and consent of the legal guardian.

D. In both work assignments and employment, the program director shall evaluate the appropriateness of the work and the fairness of the pay.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-1040 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; repealed, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-1050 Resident visitation at the homes of staff

If a provider permits staff to take residents to the staff's home, the facility must receive written permission of the resident's legal guardian or placing agency before the visit occurs. The written permission shall be kept in the resident's record.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-1060 Vehicles and power equipment

A. Transportation provided for or used by children shall comply with local, state, and federal laws relating to:

1. Vehicle safety and maintenance;

2. Licensure of vehicles;

3. Licensure of drivers; and

4. Child passenger safety, including requiring children to wear appropriate seat belts or restraints for the vehicle in which they are being transported.

B. There shall be written safety rules for transportation of residents appropriate to the population served that shall include taking head counts at each stop.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-1070 Serious incident reports

A. Any serious incident, accident, or injury to the resident; any overnight absence from the facility without permission; any runaway; and any other unexplained absence shall be reported within 24 hours (i) to the placing agency; (ii) to either the parent or legal guardian, or both as appropriate; and (iii) noted in the resident's record.

B. The provider shall document the following:

1. The date and time the incident occurred;

2. A brief description of the incident;

3. The action taken as a result of the incident;

4. The name of the person who completed the report;

5. The name of the person who made the report to the placing agency and to either the parent or legal guardian; and

6. The name of the person to whom the report was made.

C. The provider shall notify the department within 24 hours of any serious illness or injury, any death of a resident, and all other situations as required by the department. Such reports shall include:

1. The date and time the incident occurred;

2. A brief description of the incident;

3. The action taken as a result of the incident;

4. The name of the person who completed the report;

5. The name of the person who made the report to the placing agency and to either the parent or legal guardian; and

6. The name of the person to whom the report was made.

D. In the case of a serious injury or death, the report shall be made on forms approved by the department.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-1080 Suspected child abuse or neglect

A. Written policies and procedures related to child abuse and neglect shall be distributed to all staff members. These shall include procedures for:

1. Handling accusations against staff; and

2. Promptly referring, consistent with requirements of the Code of Virginia, suspected cases of child abuse and neglect to the local child protective services unit and for cooperating with the unit during any investigation.

B. Any case of suspected child abuse or neglect shall be reported to the local child protective services unit as required by the Code of Virginia.

C. Any case of suspected child abuse or neglect occurring at the facility, on a facility-sponsored event or excursion, or involving facility staff shall be reported immediately to (i) the Office of Human Rights and placing agency; and (ii) either the resident's parent or legal guardian, or both, as appropriate.

D. When a case of suspected child abuse or neglect is reported to child protective services, the resident's record shall include:

1. The date and time the suspected abuse or neglect occurred;

2. A description of the suspected abuse or neglect;

3. Action taken as a result of the suspected abuse or neglect; and

4. The name of the person to whom the report was made at the local child protective services unit.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

12VAC35-46-1090 Human rights complaint process

The provider shall comply with the Office of Human Rights regulations, including the human rights complaint process outlined in 12VAC35-115-175.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

Part V Disaster or Emergency Planning

12VAC35-46-1100 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; repealed, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-1110 Emergency and evacuation procedures

A. The provider shall develop a written emergency preparedness and response plan for all locations. The plan shall address:

1. Documentation of contact with the local emergency coordinator to determine (i) local disaster risks; (ii) communitywide plans to address different disasters and emergency situations; and (iii) assistance, if any, that the local emergency management office will provide to the facility in an emergency;

2. Analysis of the provider's capabilities and potential hazards, including natural disasters, severe weather, fire, flooding, work place violence or terrorism, missing persons, severe injuries, or other emergencies that would disrupt the normal course of service delivery;

3. Written emergency management policies outlining specific responsibilities for provision of administrative direction and management of response activities, coordination of logistics during the emergency, communications, life safety of employees, contractors, students/intern, volunteers, visitors and residents, property protection, community outreach, and recovery and restoration;

4. Written emergency response procedures for assessing the situation; protecting residents, employees, contractors, students/interns, volunteers, visitors, equipment, and vital records; and restoring services. Emergency response procedures shall address:

a. Communicating with employees, contractors, and community responders;

b. Warning and notification of residents;

c. Providing emergency access to secure areas and opening locked doors;

d. Conducting evacuations to emergency shelters or alternative sites and accounting for all residents;

e. Relocating residents, if necessary;

f. Notifying family members, if appropriate, and legal guardians;

g. Alerting emergency personnel and sounding alarms; and

h. Locating and shutting off utilities when necessary;

5. Supporting documents that would be needed in an emergency, including emergency call lists, building and site maps necessary to shut off utilities, designated escape routes, and list of major resources such as local emergency shelters; and

6. Schedule for testing the implementation of the plan and conducting emergency preparedness drills.

B. The provider shall develop emergency preparedness and response training for all employees, contractors, students/interns, and volunteers that shall include responsibilities for:

1. Alerting emergency personnel and sounding alarms;

2. Implementing evacuation procedures, including evacuation of residents with special needs (i.e., deaf, blind, nonambulatory);

3. Using, maintaining, and operating emergency equipment;

4. Accessing emergency information for residents including medical information; and

5. Utilizing community support services.

C. The provider shall document the review of the emergency preparedness plan annually and make necessary revisions. Such revisions shall be communicated to employees, contractors, students, and volunteers and incorporated into training for employees, contractors, students/interns, and volunteers and orientation of residents to services.

D. In the event of a disaster, fire, emergency, or any other condition that may jeopardize the health, safety, and welfare of residents, the provider shall take appropriate action to protect the health, safety, and welfare of the residents and take appropriate action to remedy the conditions as soon as possible.

E. Employees, contractors, students/interns, and volunteers shall be knowledgeable in and prepared to implement the emergency preparedness plan in the event of an emergency.

F. In the event of a disaster, fire, emergency, or any other condition that may jeopardize the health, safety, and welfare of residents, the provider should first respond and stabilize the disaster/emergency. After the disaster/emergency is stabilized, the provider shall report the disaster/emergency and the conditions at the facility to the legal guardian and the placing agency as soon as possible of the conditions at the facility and report the disaster/emergency to the department as soon as possible, but no later than 72 hours after the incident occurs.

G. Floor plans showing primary and secondary means of egress shall be posted on each floor in locations where they can easily be seen by staff and residents.

H. The procedures and responsibilities reflected in the emergency procedures shall be communicated to all residents within seven days following admission or a substantive change in the procedures.

I. At least one evacuation drill (the simulation of the facility's emergency procedures) shall be conducted each month in each building occupied by residents.

J. Evacuation drills shall include, at a minimum:

1. Sounding of emergency alarms;

2. Practice in evacuating buildings;

3. Practice in alerting emergency authorities;

4. Simulated use of emergency equipment; and

5. Practice in securing resident emergency information.

K. During any three consecutive calendar months, at least one evacuation drill shall be conducted during each shift.

L. A record shall be maintained for each evacuation drill and shall include the following:

1. Buildings in which the drill was conducted;

2. Date and time of drill;

3. Amount of time to evacuate the buildings;

4. Specific problems encountered;

5. Staff tasks completed including:

a. Head count; and

b. Practice in notifying emergency authorities.

6. The name of the staff members responsible for conducting and documenting the drill and preparing the record.

M. The record for each evacuation drill shall be retained for three years after the drill, unless a longer retention period is required by applicable law or regulation.

N. The facility shall assign one staff member who shall ensure that all requirements regarding the emergency preparedness and response plan and the evacuation drill program are met.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009.

Part VI Special Programs

12VAC35-46-1120 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; repealed, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-1130 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; repealed, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-1140 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 25, Issue 21, eff. August 6, 2009; repealed, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-46-1150 (Reserved)

History

• Statutory Authority: §§ 37.2-302 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-46-1160 Clinically managed, medium-intensity residential services Level of care 3.5 staff criteria

A clinically managed, medium-intensity residential care program shall meet the following staff requirements. The program shall:

1. Ensure the availability of emergency consultation with a licensed physician by telephone or in person in case of emergency related to an individual's substance use disorder, available 24 hours a day, seven days a week. The program shall also provide allied health professional staff 24 hours a day;

2. Provide licensed clinicians who are able to obtain and interpret information regarding the signs and symptoms of intoxication and withdrawal, as well as the appropriate monitoring and treatment of those conditions and how to facilitate entry into ongoing care;

3. Provide appropriately trained staff who are competent to implement physician-approved protocols for the child's or adolescent's observation, supervision, and treatment, including over the counter medications for symptomatic relief, determination for the appropriate level of care, and facilitation of the child's or adolescent's transition to continuing care;

4. Provide staff training that shall include at a minimum the requirements within 12VAC35-46-310, and all staff administering over the counter medications shall complete the training program approved by the Board of Nursing and required by subsection L of § 54.1-3408 of the Code of Virginia;

5. Provide access, as needed, to medical evaluation and consultation, which shall be available 24 hours a day to monitor the safety and outcome of withdrawal management in this setting, in accordance with the provider's written criteria for admission and discharge as required by 12VAC35-46-640 and 12VAC35-46-765; and

6. Ensure all clinical staff are qualified by training and experience and appropriately licensed, certified, or registered by the appropriate health regulatory board to serve individuals admitted to the service.

History

• Statutory Authority: §§ 37.2-302 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-46-1170 Clinically managed, medium-intensity residential services Level of care 3.5 program criteria

A clinically managed, medium-intensity residential care program shall meet the following programmatic requirements. The program shall:

1. Provide daily clinical services, including a range of cognitive, behavioral, and other therapies in individual or group therapy, programming, and psychoeducation as deemed appropriate by a licensed professional and included in an assessment and treatment plan;

2. Provide counseling and clinical interventions to teach a child or adolescent the skills needed for daily productive activity, prosocial behavior, and reintegration into family and community;

3. Provide motivational enhancement and engagement strategies appropriate to the child's or adolescent's stage of readiness to change and level of comprehension;

4. Have direct affiliations with other easily accessible levels of care or coordinate through referral to more or less intensive levels of care and other services;

5. Provide family and caregiver treatment services as deemed appropriate by a licensed professional and included in an assessment and treatment plan;

6. Provide educational, vocational, and informational programming adaptive to individual needs;

7. Utilize random drug screening to monitor progress and reinforce treatment gains as appropriate to an individual treatment plan;

8. Ensure and document that the length of stay is determined by the child's or adolescent's condition and functioning;

9. Make medication assisted treatment (MAT) available for all individuals with opioid use disorder or alcohol use disorder. MAT may be provided by facility staff or coordinated through alternative resources;

10. Provide educational services in accordance with state law to maintain the educational and intellectual development of the child or adolescent while they are admitted to the service. When indicated, additional educational opportunities shall be provided to remedy deficits in the educational level of children or adolescents who have fallen behind because of their involvement with alcohol and other drugs;

11. Ensure that all children and adolescents served by the residential service have access to the substance use treatment program; and

12. Provide daily clinical services to assess and address the child's or adolescent's withdrawal status and service needs. This may include nursing or medical monitoring, use of medications to alleviate symptoms, or individual or group therapy or programming specific to withdrawal and withdrawal support.

History

• Statutory Authority: §§ 37.2-302 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-46-1180 Clinically managed, medium-intensity residential services Level of care 3.5 admission criteria

A. A clinically managed, medium-intensity residential care program provides treatment for children who have impaired functioning across a broad range of psychosocial domains, including disruptive behaviors, delinquency and juvenile justice involvement, educational difficulties, family conflicts and chaotic home situations, developmental immaturity, and psychological problems.

B. Before a clinically managed, medium-intensity residential service program may admit a child or adolescent, the child or adolescent shall meet the criteria for admission as defined by the provider's policies. The provider's policy regarding admission shall at a minimum require the child or adolescent to:

1. Meet diagnostic criteria for a substance use disorder or addictive disorder of moderate to high severity as defined by the DSM; and

2. Meet the admission criteria of Level 3.5 of ASAM, including the specific criteria for adolescent populations.

History

• Statutory Authority: §§ 37.2-302 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-46-1190 Clinically managed, medium-intensity residential services Level of care 3.5 discharge criteria

Before a clinically managed, medium-intensity residential service program may discharge or transfer a child or adolescent, the child or adolescent shall meet the criteria for discharge or transfer as defined by the provider's policies, which shall include provisions for the discharge or transfer of children or adolescents who have:

1. Achieved the goals of the treatment services and no longer require ASAM 3.5 level of care;

2. Been unable to achieve the goals of the child's or adolescent's treatment but could achieve the child's or adolescent's goals with a different type of treatment; or

3. Achieved the child's or adolescent's original treatment goals but have developed new treatment challenges that can only be adequately addressed in a different type of treatment.

History

• Statutory Authority: §§ 37.2-302 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-46-1200 Clinically managed, medium-intensity residential services Level of care 3.5 co-occurring enhanced programs

A. Clinically managed, medium-intensity residential services co-occurring enhanced programs shall offer psychiatric services, medication evaluation, and laboratory services. Such services shall be available by telephone within eight hours and onsite or closely coordinated offsite within 24 hours.

B. Clinically managed, medium-intensity residential services co-occurring enhanced programs shall be staffed by appropriately credentialed mental health professionals, including addiction psychiatrists, who are able to assess and treat co-occurring mental disorders and who have specialized training in behavior management techniques. All clinical staff shall be qualified by training and experience and appropriately licensed, certified, or registered by the appropriate health regulatory board to serve individuals admitted to the service.

C. Clinically managed, medium-intensity residential services co-occurring enhanced programs shall offer planned clinical activities designed to stabilize the child's or adolescent's mental health problems and psychiatric symptoms and to maintain such stabilization, including medication education and management and motivational and engagement strategies. Goals of therapy shall apply to both the substance use disorder and any co-occurring mental disorder.

History

• Statutory Authority: §§ 37.2-302 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-46-1210 Clinically managed, low-intensity residential services Level of care 3.1 staff criteria

A clinically managed, low-intensity residential services program shall meet the following staff requirements. The program shall:

1. Offer telephone or in-person consultation with a physician and emergency services, available 24 hours a day, seven days a week by the clinically managed, low-intensity residential services provider. The program shall also provide allied health professional staff present onsite 24 hours a day;

2. Have clinical staff, with the credentials described in subdivision 3 of this section, who are knowledgeable about the biological and psychosocial dimensions of substance use disorder and their treatment and are able to identify the signs and symptoms of acute psychiatric conditions;

3. Have a team comprised of appropriately trained and credentialed medical, addiction, and mental health professionals;

4. Have staff that shall be knowledgeable about child or adolescent development and experienced in engaging and working with children or adolescents; and

5. Ensure all clinical staff are qualified by training and experience and appropriately licensed, certified, or registered by the appropriate health regulatory board to serve individuals admitted to the service.

History

• Statutory Authority: §§ 37.2-302 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-46-1220 Clinically managed, low-intensity residential services Level of care 3.1 program criteria

A clinically managed, low-intensity residential services program shall meet the following programmatic requirements. The program shall:

1. Offer a minimum of five hours a week of planned clinical program activities that are professionally directed, in addition to other treatment services offered to children or adolescents[]. Services shall be designed to stabilize the child's or adolescent's substance use disorder, improve the child's or adolescent's ability to structure, and organize the tasks of daily living and recovery;

2. Collaborate with care providers to develop an individual treatment plan for each child or adolescent with time-specific goals and objectives;

3. Provide counseling and clinical monitoring to support successful initial involvement in regular, productive daily activity;

4. Provide case management services;

5. Provide motivational interventions appropriate to the child's or adolescent's stage of readiness to change and level of comprehension;

6. Maintain direct affiliations with other easily accessible levels of care or coordinate through referral to more or less intensive levels of care and other services. Include the ability to arrange for needed procedures as appropriate to the severity and urgency of the child's or adolescent's condition;

7. Provide family and caregiver treatment and peer recovery support services as deemed appropriate by a licensed professional and included in an assessment and treatment plan;

8. Provide addiction pharmacotherapy and the ability to arrange for pharmacotherapy for psychiatric medications;

9. Utilize random drug screening to monitor progress and reinforce treatment gains;

10. Ensure that all children and adolescents served by the residential service have access to the substance use treatment program; and

11. Make MAT available for all children or adolescents with opioid use disorder or alcohol use disorder. MAT may be provided by facility staff or coordinated through alternative resources.

History

• Statutory Authority: §§ 37.2-302 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-46-1230 Clinically managed, low-intensity residential services Level of care 3.1 admission criteria

Before a clinically managed, low-intensity residential service program may admit a child or adolescent, the child or adolescent shall meet the criteria for admission as defined by the provider's policies. The provider's policy regarding admission shall at a minimum require the child or adolescent to:

1. Meet diagnostic criteria for a substance use disorder or addictive disorder of moderate to high severity as defined by the DSM; and

2. Meet the admission criteria of Level 3.1 of ASAM, including the specific criteria of adolescent populations.

History

• Statutory Authority: §§ 37.2-302 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-46-1240 Clinically managed, low-intensity residential services Level of care 3.1 discharge criteria

Before a clinically managed, low-intensity residential service program may discharge or transfer a child or adolescent, the child or adolescent shall meet the criteria for discharge or transfer as defined by the provider's policies, which shall include provisions for the discharge or transfer of children or adolescents who have:

1. Achieved the goals of the treatment services and no longer require ASAM 3.1 level of care;

2. Been unable to achieve the goals of the child's or adolescent's treatment but could achieve the child's or adolescent's goals with a different type of treatment; or

3. Achieved the child's or adolescent's original treatment goals but have developed new treatment challenges that can only be adequately addressed in a different type of treatment.

History

• Statutory Authority: §§ 37.2-302 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-46-1250 Clinically managed, low-intensity residential services Level of care 3.1 co-occurring enhanced programs

A. Clinically managed, low-intensity residential services co-occurring enhanced programs shall offer appropriate psychiatric services, including medication evaluation and laboratory services. Such services shall be provided onsite or closely coordinated offsite, as appropriate to the severity and urgency of the child's or adolescent's mental condition.

B. Clinically managed, low-intensity residential services co-occurring enhanced programs shall be staffed by appropriately credentialed mental health professionals who are able to assess and treat co-occurring disorders with the capacity to involve addiction-trained psychiatrists.

C. Clinically managed, low-intensity residential services co-occurring enhanced programs shall offer planned clinical activities that are designed to stabilize the child's or adolescent's mental health problems and psychiatric symptoms and to maintain such stabilization, including medication education and management and motivational and engagement strategies. Goals of therapy shall apply to both the substance use disorder and any co-occurring mental disorder.

History

• Statutory Authority: §§ 37.2-302 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-46-1260 Qualified residential treatment programs

A. A qualified residential treatment program (QRTP) shall have a trauma-informed treatment model that is designed to address the needs, including clinical needs as appropriate, of children with serious emotional or behavioral disorders or disturbances and, with respect to a child, is able to implement the treatment identified for the child.

B. In addition to the staffing requirements within Part II (12VAC35-46-170 et seq.) through Part VI (12VAC35-46-1120 et seq.) of this chapter, a QRTP shall have registered or licensed nursing staff and other licensed clinical staff who:

1. Provide care within the scope of their practice as defined by state law;

2. Are on-site according to the treatment model referred to in subsection A of this section; and

3. Are available 24 hours a day and seven days a week.

The QRTP is not required to acquire nursing or other clinical staff solely through means of a direct employer to employee relationship.

C. To the extent appropriate and in accordance with the child's best interests, the QRTP shall facilitate participation of family members in the child's treatment program.

D. The QRTP shall facilitate outreach to the family members of the child, including siblings, document how the outreach is made, including contact information, and maintain contact information for any known biological family and fictive kin of the child. Documentation of outreach to family members and contact information of family members shall be placed within the child's record at the QRTP.

E. The QRTP shall document how family members are integrated into the treatment process for the child, including after discharge, and how sibling connections are maintained. Documentation of family member integration shall be placed within the child's record at the QRTP.

F. The QRTP shall provide or ensure discharge planning and family-based aftercare support for at least six months following discharge.

G. The QRTP shall be licensed in accordance with 42 USC § 471(a)(10) and accredited by any of the following independent nonprofit organizations:

1. The Commission on Accreditation of Rehabilitation Facilities (CARF);

2. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO);

3. The Council on Accreditation (COA); or

4. Any other independent, nonprofit accrediting organization approved by the U.S. Secretary of Health and Human Services.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 40, Issue 6, eff. December 7, 2023.

12VAC35-46-1270 Additional requirements for QRTP placements for children within the custody of local social service boards

A. The qualified residential treatment program (QRTP) shall coordinate with the local departments of social services, the child's biological family members, relative and fictive kin of the child, and, as appropriate, professionals who are a resource to the family of the child, such as teachers, clergy, or medical or mental health providers who have treated the child.

B. All documents related to a child's need for placement shall be placed within the child's record at the qualified residential treatment program, including the assessment determination of the qualified individual, as defined in 42 USC § 675a(c)(1)(D)(i), and the written documentation of the approval or disapproval of the placement in a qualified residential treatment program by a court or administrative body.

C. This section shall not apply to direct parental placements of children into the QRTP that are made outside of the social services system.

History

• Statutory Authority: §§ 37.2-203 and 37.2-408 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 40, Issue 6, eff. December 7, 2023.

Chapter 105 Rules and Regulations for Licensing Providers by the Department of Behavioral Health and Developmental Services

Article 1 Authority and Applicability

12VAC35-105-10 Authority and applicability

A. Section 37.2-404 of the Code of Virginia authorizes the commissioner to license providers subject to rules and regulations adopted by the State Board of Behavioral Health and Developmental Services.

B. No provider shall establish, maintain, conduct, or operate any service without first receiving a license from the commissioner.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

Article 2 Definitions

12VAC35-105-20 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Abuse" means, as defined by § 37.2-100 of the Code of Virginia, any act or failure to act by an employee or other person responsible for the care of an individual in a facility or program operated, licensed, or funded by the department, excluding those operated by the Virginia Department of Corrections, that was performed or was failed to be performed knowingly, recklessly, or intentionally, and that caused or might have caused physical or psychological harm, injury, or death to an individual receiving care or treatment for mental illness, developmental disabilities, or substance abuse. Examples of abuse include acts such as:

1. Rape, sexual assault, or other criminal sexual behavior;

2. Assault or battery;

3. Use of language that demeans, threatens, intimidates, or humiliates the individual;

4. Misuse or misappropriation of the individual's assets, goods, or property;

5. Use of excessive force when placing an individual in physical or mechanical restraint;

6. Use of physical or mechanical restraints on an individual that is not in compliance with federal and state laws, regulations, and policies, professional accepted standards of practice, or the individual's individualized services plan; or

7. Use of more restrictive or intensive services or denial of services to punish an individual or that is not consistent with the individual's individualized services plan.

"Activities of daily living" or "ADLs" means personal care activities and includes bathing, dressing, transferring, toileting, grooming, hygiene, feeding, and eating. An individual's degree of independence in performing these activities is part of determining the appropriate level of care and services.

"Addiction" means a primary, chronic disease of brain reward, motivation, memory, and related circuitry. Addiction is defined as the inability to consistently abstain, impairment in behavioral control, persistence of cravings, diminished recognition of significant problems with one's behaviors and interpersonal relationships, and a dysfunctional emotional response. Like other chronic diseases, addiction often involves cycles of relapse and remission. Without treatment or engagement in recovery activities, addiction is progressive and can result in disability or premature death.

"Admission" means the process of acceptance into a service as defined by the provider's policies.

"Allied health professional" means a professional who is involved with the delivery of health or related services pertaining to the identification, evaluation, and prevention of diseases and disorders, such as a certified substance abuse counselor, certified substance abuse counseling assistant, peer recovery support specialist, certified nurse aide, or occupational therapist.

"ASAM" means the American Society of Addiction Medicine.

"Assertive community treatment service" or "ACT" means a self-contained interdisciplinary community-based team of medical, behavioral health, and rehabilitation professionals who use a team approach to meet the needs of an individual with severe and persistent mental illness. ACT teams:

1. Provide person-centered services addressing the breadth of an individual's needs, helping the individual achieve his personal goals;

2. Serve as the primary provider of all the services that an individual receiving ACT services needs;

3. Maintain a high frequency and intensity of community-based contacts;

4. Maintain a very low individual-to-staff ratio;

5. Offer varying levels of care for all individuals receiving ACT services and appropriately adjust service levels according to each individual's needs over time;

6. Assist individuals in advancing toward personal goals with a focus on enhancing community integration and regaining valued roles, such as worker, family member, resident, spouse, tenant, or friend;

7. Carry out planned assertive engagement techniques, including rapport-building strategies, facilitating meeting basic needs, and motivational interviewing techniques;

8. Monitor the individual's mental status and provide needed supports in a manner consistent with the individual's level of need and functioning;

9. Deliver all services according to a recovery-based philosophy of care; and

10. Promote self-determination, respect for the individual receiving ACT as an individual in such individual's own right, and engage peers in promoting recovery and regaining meaningful roles and relationships in the community.

"Authorized representative" means a person permitted by law or 12VAC35-115 to authorize the disclosure of information or consent to treatment and services or participation in human research.

"Behavior intervention" means those principles and methods employed by a provider to help an individual receiving services to achieve a positive outcome and to address challenging behavior in a constructive and safe manner. Behavior intervention principles and methods shall be employed in accordance with the individualized services plan and written policies and procedures governing service expectations, treatment goals, safety, and security.

"Behavioral treatment plan," "functional plan," or "behavioral support plan" means any set of documented procedures that are an integral part of the individualized services plan and are developed on the basis of a systematic data collection, such as a functional assessment, for the purpose of assisting individuals to achieve the following:

1. Improved behavioral functioning and effectiveness;

2. Alleviation of symptoms of psychopathology; or

3. Reduction of challenging behaviors.

"Board" or "state board" means, as defined by § 37.2-100 of the Code of Virginia, the State Board of Behavioral Health and Developmental Services. The board has statutory responsibility for adopting regulations that may be necessary to carry out the provisions of Title 37.2 of the Code of Virginia and other laws of the Commonwealth administered by the commissioner or the department.

"Brain injury" means any injury to the brain that occurs after birth that is acquired through traumatic or nontraumatic insults. Nontraumatic insults may include anoxia, hypoxia, aneurysm, toxic exposure, encephalopathy, surgical interventions, tumor, and stroke. Brain injury does not include hereditary, congenital, or degenerative brain disorders or injuries induced by birth trauma.

"Care," "treatment," or "support" means the individually planned therapeutic interventions that conform to current acceptable professional practice and that are intended to improve or maintain functioning of an individual receiving services delivered by a provider.

"Case management service" or "support coordination service" means services that can include assistance to individuals and their family members in accessing needed services that are responsive to the individual's needs. Case management services include identifying potential users of the service; assessing needs and planning services; linking the individual to services and supports; assisting the individual directly to locate, develop, or obtain needed services and resources; coordinating services with other providers; enhancing community integration; making collateral contacts; monitoring service delivery; discharge planning; and advocating for individuals in response to their changing needs. "Case management service" does not include assistance in which the only function is maintaining service waiting lists or periodically contacting or tracking individuals to determine potential service needs.

"Clinical experience" means providing direct services to individuals with mental illness or the provision of direct geriatric services or special education services. Experience may include supervised internships, practicums, and field experience.

"Clinically managed high-intensity residential care" or "Level of care 3.5" means a substance use treatment program that offers 24-hour supportive treatment of individuals with significant psychological and social problems by credentialed addiction treatment professionals in an interdisciplinary treatment approach. A clinically managed high-intensity residential care program provides treatment to individuals who present with significant challenges, such as physical, sexual, or emotional trauma; past criminal or antisocial behaviors, with a risk of continued criminal behavior; an extensive history of treatment; inadequate anger management skills; extreme impulsivity; and antisocial value system.

"Clinically managed low-intensity residential care" or "Level of care 3.1" means providing an ongoing therapeutic environment for individuals requiring some structured support in which treatment is directed toward applying recovery skills; preventing relapse; improving emotional functioning; promoting personal responsibility; reintegrating the individual into work, education, and family environments; and strengthening and developing adaptive skills that may not have been achieved or have been diminished during the individual's active addiction. A clinically managed low-intensity residential care program also provides treatment for individuals suffering from chronic, long-term alcoholism or drug addiction and affords an extended period of time to establish sound recovery and a solid support system.

"Clinically managed population specific high-intensity residential services" or "Level of care 3.3" means a substance use treatment program that provides a structured recovery environment in combination with high-intensity clinical services provided in a manner to meet the functional limitations of individuals. The functional limitations of individuals who are placed within this level of care are primarily cognitive and can be either temporary or permanent.

"Collaborative behavioral health services" means the same as the term is defined in § 54.1-3500 of the Code of Virginia.

"Commissioner" means the Commissioner of the Department of Behavioral Health and Developmental Services.

"Community-based crisis stabilization" means services that are short term and designed to support an individual and the individual's natural support system following contact with an initial crisis response service or as a diversion to a higher level of care. Providers deliver community-based crisis stabilization services in an individual's natural environment and provide referrals and linkage to other community-based services at the appropriate level of care. Interventions may include mobile crisis response, brief therapeutic and skill-building interventions, engagement of natural supports, interventions to integrate natural supports in the de-escalation and stabilization of the crisis, and coordination of follow-up services. Coordination of specialized services to address the needs of co-occurring developmental disabilities and substance use disorders are also available through this service. Services include advocacy and networking to provide linkages and referrals to appropriate community-based services and assist the individual and the individual's family or caregiver in accessing other benefits or assistance programs for which the individual may be eligible. Community-based crisis stabilization is a non-center, community-based service. The goal of community-based crisis stabilization services is to stabilize the individual within the community and support the individual or the individual's support system (i) as part of an initial mobile crisis response; (ii) during the period between an initial mobile crisis response and entry into an established follow-up service at the appropriate level of care; (iii) as a transitional step-down from a higher level of care if the next level of care service is identified but not immediately available for access; or (iv) as a diversion to a higher level of care.

"Community gero-psychiatric residential services" means 24-hour care provided to individuals with mental illness, behavioral problems, and concomitant health problems who are usually 65 years of age or older in a geriatric setting that is less intensive than a psychiatric hospital but more intensive than a nursing home or group home. Services include assessment and individualized services planning by an interdisciplinary services team, intense supervision, psychiatric care, behavioral treatment planning and behavior interventions, nursing, and other health-related services.

"Complaint" means an allegation of a violation of this chapter or a provider's policies and procedures related to this chapter.

"Conveyance" means a motor vehicle that serves as the mobile component of a mobile MAT program.

"Co-occurring disorders" means the presence of more than one and often several of the following disorders that are identified independently of one another and are not simply a cluster of symptoms resulting from a single disorder: mental illness, a developmental disability, substance abuse (substance use disorders), or brain injury.

"Co-occurring services" means individually planned therapeutic treatment that addresses in an integrated concurrent manner the service needs of individuals who have co-occurring disorders.

"Corrective action plan" means the provider's pledged corrective action in response to cited areas of noncompliance documented by the regulatory authority.

"Correctional facility" means a facility operated under the management and control of the Virginia Department of Corrections.

"Credentialed addiction treatment professional" means a person who possesses one of the following credentials issued by the appropriate health regulatory board: (i) an addiction-credentialed physician or physician with experience or training in addiction medicine; (ii) a licensed nurse practitioner or a licensed physician assistant with experience or training in addiction medicine; (iii) a licensed psychiatrist; (iv) a licensed clinical psychologist; (v) a licensed clinical social worker; (vi) a licensed professional counselor; (vii) a licensed nurse practitioner with experience or training in psychiatry or mental health; (viii) a licensed marriage and family therapist; (ix) a licensed substance abuse treatment practitioner; (x) a resident who is under the supervision of a licensed professional counselor (18VAC115-20-10), licensed marriage and family therapist (18VAC115-50-10), or licensed substance abuse treatment practitioner (18VAC115-60-10) and is registered with the Virginia Board of Counseling; (xi) a resident in psychology who is under supervision of a licensed clinical psychologist and is registered with the Virginia Board of Psychology (18VAC125-20-10); or (xii) a supervisee in social work who is under the supervision of a licensed clinical social worker and is registered with the Virginia Board of Social Work (18VAC140-20-10).

"Crisis" means a deteriorating or unstable situation often developing suddenly or rapidly that produces acute, heightened, emotional, mental, physical, medical, or behavioral distress.

"Crisis education and prevention plan" or "CEPP" means a department-approved, individualized, client-specific document that provides a concise, clear, and realistic set of supportive interventions to prevent or de-escalate a crisis and assist an individual who may be experiencing a behavioral loss of control. The goal of the CEPP is to identify problems that have arisen in the past or are emergent in order to map out strategies that offer tools for the natural support system to assist the individual in addressing and de-escalating problems in a healthy way and provide teaching skills that the individual can apply independently.

"Crisis planning team" means the team who is consulted to plan the individual's safety plan or crisis ISP. The crisis planning team consists, at a minimum, of the individual receiving services, the individual's legal guardian or authorized representative, and a member of the provider's crisis staff. The crisis planning team may include the individual's support coordinator, case manager, the individual's family, or other identified persons, as desired by the individual, such as the individual's family of choice.

"Crisis receiving center," "CRC," or "23-hour crisis stabilization" means a community-based, nonhospital facility providing short-term assessment, observation, and crisis stabilization services for up to 23 hours. This service is accessible 24 hours per day, seven days per week, 365 days per year, and is indicated when an individual requires a safe environment for initial assessment and intervention. This service includes a thorough assessment of an individual's behavioral health crisis, psychosocial needs, and supports in order to determine the least restrictive environment most appropriate for stabilization. Key service functions include rapid assessment, crisis intervention, de-escalation, short-term stabilization, and appropriate referrals for ongoing care. This distinct service may be co-located with other services such as crisis stabilization units.

"Crisis stabilization" means direct, intensive nonresidential or residential care and treatment to nonhospitalized individuals experiencing an acute crisis that may jeopardize their current community living situation. Crisis stabilization is intended to avert hospitalization or rehospitalization; provide normative environments with a high assurance of safety and security for crisis intervention; stabilize individuals in crisis; and mobilize the resources of the community support system, family members, and others for ongoing rehabilitation and recovery.

"Crisis stabilization unit," "CSU," or "residential crisis stabilization unit" is a community-based, short-term residential treatment unit. CSUs serve as primary alternatives to inpatient hospitalization for individuals who are in need of a safe, secure environment for assessment and crisis treatment. CSUs also serve as a step-down option from psychiatric inpatient hospitalization and function to stabilize and reintegrate individuals who meet medical necessity criteria back into their communities.

"Day support service" means structured programs of training, assistance, and specialized supervision in the acquisition, retention, or improvement of self-help, socialization, and adaptive skills for adults with a developmental disability provided to groups or individuals in nonresidential community-based settings. Day support services may provide opportunities for peer interaction and community integration and are designed to enhance the following: self-care and hygiene, eating, toileting, task learning, community resource utilization, environmental and behavioral skills, social skills, medication management, prevocational skills, and transportation skills. The term "day support service" does not include services in which the primary function is to provide employment-related services, general educational services, or general recreational services.

"Department" means the Virginia Department of Behavioral Health and Developmental Services.

"Developmental disability" means a severe, chronic disability of an individual that (i) is attributable to a mental or physical impairment or a combination of mental and physical impairments other than a sole diagnosis of mental illness; (ii) is manifested before the individual reaches 22 years of age; (iii) is likely to continue indefinitely; (iv) results in substantial functional limitations in three or more of the following areas of major life activity: self-care, receptive and expressive language, learning, mobility, self-direction, capacity for independent living, or economic self-sufficiency; and (v) reflects the individual's need for a combination and sequence of special interdisciplinary or generic services, individualized supports, or other forms of assistance that are of lifelong or extended duration and are individually planned and coordinated. An individual from birth to nine years of age, inclusive, who has a substantial developmental delay or specific congenital or acquired condition may be considered to have a developmental disability without meeting three or more of the criteria described in clauses (i) through (v) if the individual without services and supports has a high probability of meeting those criteria later in life.

"Developmental services" means planned, individualized, and person-centered services and supports provided to individuals with developmental disabilities for the purpose of enabling these individuals to increase their self-determination and independence, obtain employment, participate fully in all aspects of community life, advocate for themselves, and achieve their fullest potential to the greatest extent possible.

"Diagnostic and Statistical Manual of Mental Disorders" or "DSM" means the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, DSM-5, of the American Psychiatric Association.

"Direct care position" means any position that includes responsibility for (i) treatment, case management, health, safety, development, or well-being of an individual receiving services or (ii) immediately supervising a person in a position with this responsibility.

"Discharge" means the process by which the individual's active involvement with a service is terminated by the provider, individual, or individual's authorized representative.

"Discharge plan" means the written plan that establishes the criteria for an individual's discharge from a service and identifies and coordinates delivery of any services needed after discharge.

"Dispense" means to deliver a drug to an ultimate user by or pursuant to the lawful order of a practitioner, including the prescribing and administering, packaging, labeling, or compounding necessary to prepare the substance for that delivery (§ 54.1-3400 et seq. of the Code of Virginia).

"Emergency service" means unscheduled and sometimes scheduled crisis intervention, stabilization, and referral assistance provided over the telephone or face-to-face, if indicated, available 24 hours a day and seven days per week. Emergency services also may include walk-ins, home visits, jail interventions, and preadmission screening activities associated with the judicial process.

"Group home or community residential service" means a congregate service providing 24-hour supervision in a community-based home having eight or fewer residents. Services include supervision, supports, counseling, and training in activities of daily living for individuals whose individualized services plan identifies the need for the specific types of services available in this setting.

"HCBS Waiver" means a Medicaid Home and Community Based Services Waiver.

"Home and noncenter based" means that a service is provided in the individual's home or other noncenter-based setting. This includes noncenter-based day support, supportive in-home, and intensive in-home services.

"Individual" or "individual receiving services" means a current direct recipient of public or private mental health, developmental, or substance abuse treatment, rehabilitation, or habilitation services and includes the terms "consumer," "patient," "resident," "recipient," or "client". When the term is used in this chapter, the requirement applies to every individual receiving licensed services from the provider.

"Individualized services plan" or "ISP" means a comprehensive and regularly updated written plan that describes the individual's needs, the measurable goals and objectives to address those needs, and strategies to reach the individual's goals. An ISP is person-centered, empowers the individual, and is designed to meet the needs and preferences of the individual. The ISP is developed through a partnership between the individual and the provider and includes an individual's treatment plan, habilitation plan, person-centered plan, or plan of care, which are all considered individualized service plans.

"Informed choice" means a decision made after considering options based on adequate and accurate information and knowledge. These options are developed through collaboration with the individual and the individual's authorized representative, as applicable, and the provider with the intent of empowering the individual and the individual's authorized representative to make decisions that will lead to positive service outcomes.

"Informed consent" means the voluntary written agreement of an individual or that individual's authorized representative to surgery, electroconvulsive treatment, use of psychotropic medications, or any other treatment or service that poses a risk of harm greater than that ordinarily encountered in daily life or for participation in human research. To be voluntary, informed consent must be given freely and without undue inducement; any element of force, fraud, deceit, or duress; or any form of constraint or coercion.

"Initial assessment" means an assessment conducted prior to or at admission to determine whether the individual meets the service's admission criteria; what the individual's immediate service, health, and safety needs are; and whether the provider has the capability and staffing to provide the needed services.

"Inpatient psychiatric service" means intensive 24-hour medical, nursing, and treatment services provided to individuals with mental illness or substance abuse (substance use disorders) in a hospital as defined in § 32.1-123 of the Code of Virginia or in a special unit of a hospital.

"Instrumental activities of daily living" or "IADLs" means meal preparation, housekeeping, laundry, and managing money. A person's degree of independence in performing these activities is part of determining appropriate level of care and services.

"Intellectual disability" means a disability originating before 18 years of age, characterized concurrently by (i) significant subaverage intellectual functioning as demonstrated by performance on a standardized measure of intellectual functioning administered in conformity with accepted professional practice that is at least two standard deviations below the mean and (ii) significant limitations in adaptive behavior as expressed in conceptual, social, and practical adaptive skills.

"Intensity of service" means the number, type, and frequency of staff interventions and other services provided during treatment at a particular level of care.

"Intensive in-home service" means family preservation interventions for children and adolescents who have or are at risk of serious emotional disturbance, including individuals who also have a diagnosis of developmental disability. Intensive in-home service is usually time-limited and is provided typically in the residence of an individual who is at risk of being moved to out-of-home placement or who is being transitioned back home from an out-of-home placement. The service includes 24-hour per day emergency response; crisis treatment; individual and family counseling; life, parenting, and communication skills; and case management and coordination with other services.

"Intermediate care facility/individuals with intellectual disability" or "ICF/IID" means a facility or distinct part of a facility certified by the Virginia Department of Health as meeting the federal certification regulations for an intermediate care facility for individuals with intellectual disability and persons with related conditions and that addresses the total needs of the residents, which include physical, intellectual, social, emotional, and habilitation, providing active treatment as defined in 42 CFR 435.1010 and 42 CFR 483.440.

"Investigation" means a detailed inquiry or systematic examination of the operations of a provider or its services regarding an alleged violation of regulations or law. An investigation may be undertaken as a result of a complaint, an incident report, or other information that comes to the attention of the department.

"Licensed mental health professional" or "LMHP" means a physician, licensed clinical psychologist, licensed professional counselor, licensed clinical social worker, licensed substance abuse treatment practitioner, licensed marriage and family therapist, certified psychiatric clinical nurse specialist, licensed behavior analyst, or licensed psychiatric/mental health nurse practitioner.

"Location" means a place where services are or could be provided.

"Mandatory outpatient treatment order" means an order issued by a court pursuant to § 37.2-817 of the Code of Virginia.

"Medical evaluation" means the process of assessing an individual's health status that includes a medical history and a physical examination of an individual conducted by a licensed medical practitioner operating within the scope of his license.

"Medically managed intensive inpatient service" or "Level of care 4.0" means an organized service delivered in an inpatient setting, including an acute care general hospital, psychiatric unit in a general hospital, or a freestanding psychiatric hospital. This service is appropriate for individuals whose acute biomedical and emotional, behavioral, and cognitive problems are so severe that they require primary medical and nursing care. Services at this level of care are managed by a physician who is responsible for diagnosis, treatment, and treatment plan decisions in collaboration with the individual.

"Medically monitored intensive inpatient treatment" or "Level of care 3.7" means a substance use treatment program that provides 24-hour care in a facility under the supervision of medical personnel. The care provided includes directed evaluation, observation, medical monitoring, and addiction treatment in an inpatient setting. The care provided may include the use of medication to address the effects of substance use. This service is appropriate for an individual whose subacute biomedical, emotional, behavioral, or cognitive problems are so severe that they require inpatient treatment but who does not need the full resources of an acute care general hospital or a medically managed intensive inpatient treatment program.

"Medication" means prescribed or over-the-counter drugs or both.

"Medication administration" means the legally permitted direct application of medications, as enumerated by § 54.1-3408 of the Code of Virginia, by injection, inhalation, ingestion, or any other means to an individual receiving services by (i) persons legally permitted to administer medications or (ii) the individual at the direction and in the presence of persons legally permitted to administer medications.

"Medication-assisted treatment" or "MAT" means the use of U.S. Food and Drug Administration approved medications in combination with counseling and behavioral therapies to provide treatment of substance use disorders. Medication-assisted treatment includes medications for opioid use disorder as well as medications for treatment of alcohol use disorder.

"Medication error" means an error in administering a medication to an individual and includes when any of the following occur: (i) the wrong medication is given to an individual, (ii) the wrong individual is given the medication, (iii) the wrong dosage is given to an individual, (iv) medication is given to an individual at the wrong time or not at all, or (v) the wrong method is used to give the medication to the individual.

"Medication for opioid use disorder" or "MOUD" means medications, including opioid agonist medications, approved by the U.S. Food and Drug Administration for the use in the treatment of opioid use disorder.

"Medication storage" means any area where medications are maintained by the provider, including a locked cabinet, locked room, or locked box.

"Mental Health Community Support Service" or "MCHSS" means the provision of recovery-oriented services to individuals with long-term, severe mental illness. MHCSS includes skills training and assistance in accessing and effectively utilizing services and supports that are essential to meeting the needs identified in the individualized services plan and development of environmental supports necessary to sustain active community living as independently as possible. MHCSS may be provided in any setting in which the individual's needs can be addressed, skills training applied, and recovery experienced.

"Mental health intensive outpatient service" means a structured program of skilled treatment services focused on maintaining and improving functional abilities through a time-limited, interdisciplinary approach to treatment. This service is provided over a period of time for individuals requiring more intensive services than an outpatient service can provide and may include individual, family, or group counseling or psychotherapy; skill development and psychoeducational activities; certified peer support services; medication management; and psychological assessment or testing.

"Mental health outpatient service" means treatment provided to individuals on an hourly schedule, on an individual, group, or family basis, and usually in a clinic or similar facility or in another location. Mental health outpatient services may include diagnosis and evaluation, screening and intake, counseling, psychotherapy, behavior management, psychological testing and assessment, laboratory, and other ancillary services, medical services, and medication services. Mental health outpatient service specifically includes:

1. Mental health services operated by a community services board or a behavioral health authority established pursuant to Chapter 5 (§ 37.2-500 et seq.) or Chapter 6 (§ 37.2-600 et seq.) of Title 37.2 of the Code of Virginia;

2. Mental health services contracted by a community services board or a behavioral health authority established pursuant to Chapter 5 (§ 37.2-500 et seq.) or Chapter 6 (§ 37.2-600 et seq.) of Title 37.2 of the Code of Virginia; or

3. Mental health services that are owned, operated, or controlled by a corporation organized pursuant to the provisions of either Chapter 9 (§ 13.1-601 et seq.) or Chapter 10 (§ 13.1-801 et seq.) of Title 13.1 of the Code of Virginia.

"Mental health partial hospitalization service" means time-limited active treatment interventions that are more intensive than outpatient services, designed to stabilize and ameliorate acute symptoms and serve as an alternative to inpatient hospitalization or to reduce the length of a hospital stay. Partial hospitalization is provided through a minimum of 20 hours per week of skilled treatment services focused on individuals who require intensive, highly coordinated, structured, and interdisciplinary ambulatory treatment within a stable environment that is of greater intensity than intensive outpatient, but of lesser intensity than inpatient.

"Mental illness" means, as defined by § 37.2-100 of the Code of Virginia, a disorder of thought, mood, emotion, perception, or orientation that significantly impairs judgment, behavior, capacity to recognize reality, or ability to address basic life necessities and requires care and treatment for the health, safety, or recovery of the individual or for the safety of others.

"Missing" means a circumstance in which an individual is not physically present when and where he should be and his absence cannot be accounted for or explained by his supervision needs or pattern of behavior.

"Mobile crisis response" means a type of community-based crisis stabilization service that is available 24 hours per day, seven days per week, 365 days per year to provide rapid response, assessment, and early intervention to individuals experiencing a behavioral health crisis. Services are deployed in real time to the location of the individual experiencing a behavioral health crisis. The purpose of this service is to (i) de-escalate the behavioral health crisis and prevent harm to the individual or others; (ii) assist in the prevention of the individual's acute exacerbation of symptoms; (iii) develop an immediate plan to maintain safety; and (iv) coordinate care and linking to appropriate treatment services to meet the needs of the individual.

"Mobile medication-assisted treatment program" or "mobile MAT program" means a MAT operating from a motor vehicle or conveyance that serves as a mobile component to a licensed MAT location registered with the U.S. Drug Enforcement Administration as required by 21 CFR 1301.11 et seq.

"Motivational enhancement" means a person-centered approach that is collaborative, employs strategies to strengthen motivation for change, increases engagement in substance use services, resolves ambivalence about changing substance use behaviors, and supports individuals to set goals to change their substance use.

"Neglect" means, as defined by § 37.2-100 of the Code of Virginia, the failure by a person or a program or facility operated, licensed, or funded by the department, excluding those operated by the Department of Corrections, responsible for providing services to do so, including nourishment, treatment, care, goods, or services necessary to the health, safety, or welfare of an individual receiving care or treatment for mental illness, developmental disabilities, or substance abuse.

"Neurobehavioral services" means the assessment, evaluation, and treatment of cognitive, perceptual, behavioral, and other impairments caused by brain injury that affect an individual's ability to function successfully in the community.

"Office of Human Rights" means the Department of Behavioral Health and Developmental Services Office of Human Rights.

"Opioid treatment practitioner" means a health care professional who is appropriately licensed to prescribe or dispense medications in Virginia for opioid use disorders and, as a result, is authorized to practice within an opioid treatment program.

"Person-centered" means focusing on the needs and preferences of the individual; empowering and supporting the individual in defining the direction for his life; and promoting self-determination, community involvement, and recovery.

"Provider" means, as defined by § 37.2-403 of the Code of Virginia, any person, entity, or organization, excluding an agency of the federal government by whatever name or designation, that delivers (i) services to individuals with mental illness, developmental disabilities, or substance abuse (substance use disorders) or (ii) residential services for individuals with brain injury. The person, entity, or organization shall include a hospital as defined in § 32.1-123 of the Code of Virginia, community services board, behavioral health authority, private provider, and any other similar or related person, entity, or organization. It shall not include any individual practitioner who holds a license issued by a health regulatory board of the Department of Health Professions or who is exempt from licensing pursuant to §§ 54.1-2901, 54.1-3001, 54.1-3501, 54.1-3601, and 54.1-3701 of the Code of Virginia.

"Psychosocial rehabilitation service" means a program of two or more consecutive hours per day provided to groups of adults in a nonresidential setting. Individuals must demonstrate a clinical need for the service arising from a condition due to mental, behavioral, or emotional illness that results in significant functional impairments in major life activities. This service provides education to teach the individual about mental illness, substance abuse, and appropriate medication to avoid complication and relapse and opportunities to learn and use independent skills and to enhance social and interpersonal skills within a consistent program structure and environment. Psychosocial rehabilitation includes skills training, peer support, vocational rehabilitation, and community resource development oriented toward empowerment, recovery, and competency.

"Qualified developmental disability professional" or "QDDP" means a person who possesses at least one year of documented experience working directly with individuals who have a developmental disability and who possesses one of the following credentials: (i) a doctor of medicine or osteopathy licensed in Virginia, (ii) a registered nurse licensed in Virginia, (iii) a licensed occupational therapist, or (iv) completion of at least a bachelor's degree in a human services field, including sociology, social work, special education, rehabilitation counseling, or psychology.

"Qualified mental health professional" or "QMHP" means the same as the term is defined in § 54.1-3500 of the Code of Virginia.

"Qualified mental health professional-trainee" or "QMHP-T" means the same as the term is defined in § 54.1-3500 of the Code of Virginia.

"Qualified paraprofessional in mental health" or "QPPMH" means a person who meets at least one of the following criteria: (i) is registered with the United States Psychiatric Association (USPRA) as an Associate Psychiatric Rehabilitation Provider (APRP); (ii) has an associate degree in a related field (social work, psychology, psychiatric rehabilitation, sociology, counseling, vocational rehabilitation, human services counseling) and at least one year of experience providing direct services to individuals with a diagnosis of mental illness; (iii) is licensed as an occupational therapy assistant, and supervised by a licensed occupational therapist, with at least one year of experience providing direct services to individuals with a diagnosis of mental illness; or (iv) has a minimum of 90 hours classroom training and 12 weeks of experience under the direct personal supervision of a QMHP providing services to individuals with mental illness and at least one year of experience, including the 12 weeks of supervised experience.

"Quality improvement plan" means a detailed work plan developed by a provider that defines steps the provider will take to review the quality of services it provides and to manage initiatives to improve quality. A quality improvement plan consists of systematic and continuous actions that lead to measurable improvement in the services, supports, and health status of the individuals receiving services.

"Recovery" means a journey of healing and transformation enabling an individual with a mental illness to live a meaningful life in a community of his choice while striving to achieve his full potential. For individuals with substance abuse (substance use disorders), recovery is an incremental process leading to positive social change and a full return to biological, psychological, and social functioning. For individuals with a developmental disability, the concept of recovery does not apply in the sense that individuals with a developmental disability will need supports throughout their entire lives although these may change over time. With supports, individuals with a developmental disability are capable of living lives that are fulfilling and satisfying and that bring meaning to themselves and others they know.

"REACH crisis therapeutic home" or "REACH CTH" means a residential home with crisis stabilization REACH service for individuals with a developmental disability and who are experiencing a mental health or behavior crisis.

"REACH mobile crisis response" means a REACH service that provides mobile crisis response for individuals with a developmental disability and who are experiencing a mental health or behavior crisis.

"Referral" means the process of directing an applicant or an individual to a provider or service that is designed to provide the assistance needed.

"Regional education assessment crisis services habilitation" or "REACH" means the statewide crisis system of care that is designed to meet the crisis support needs of individuals who have a developmental disability and are experiencing mental health or behavior crisis events that put the individuals at risk for homelessness, incarceration, hospitalization, or danger to self or others.

"Residential" or "residential service" means providing 24-hour support in conjunction with care and treatment or a training program in a setting other than a hospital or training center. Residential services provide a range of living arrangements from highly structured and intensively supervised to relatively independent and requiring a modest amount of staff support and monitoring. Residential services include residential treatment, group homes, supervised living, community gero-psychiatric residential, ICF/IID, sponsored residential homes, withdrawal management, and neurobehavioral services.

"Residential crisis stabilization service" means (i) providing short-term, intensive treatment to nonhospitalized individuals who require multidisciplinary treatment in order to stabilize acute psychiatric symptoms and prevent admission to a psychiatric inpatient unit; (ii) providing normative environments with a high assurance of safety and security for crisis intervention; and (iii) mobilizing the resources of the community support system, family members, and others for ongoing rehabilitation and recovery.

"Residential treatment service" means providing an intensive and highly structured clinically based mental health, substance abuse, or neurobehavioral service for co-occurring disorders in a residential setting other than an inpatient service.

"Respite care service" means providing for a short-term, time-limited period of care of an individual for the purpose of providing relief to the individual's family, guardian, or regular caregiver. Persons providing respite care are recruited, trained, and supervised by a licensed provider. These services may be provided in a variety of settings including residential, day support, in-home, or a sponsored residential home.

"Restraint" means the use of a mechanical device, medication, physical intervention, or hands-on hold to prevent an individual receiving services from moving his body to engage in a behavior that places him or others at imminent risk. There are three kinds of restraints:

1. Mechanical restraint means the use of a mechanical device that cannot be removed by the individual to restrict the individual's freedom of movement or functioning of a limb or portion of an individual's body when that behavior places him or others at imminent risk.

2. Pharmacological restraint means the use of a medication that is administered involuntarily for the emergency control of an individual's behavior when that individual's behavior places him or others at imminent risk and the administered medication is not a standard treatment for the individual's medical or psychiatric condition.

3. Physical restraint, also referred to as manual hold, means the use of a physical intervention or hands-on hold to prevent an individual from moving his body when that individual's behavior places him or others at imminent risk.

"Restraints for behavioral purposes" means using a physical hold, medication, or a mechanical device to control behavior or involuntarily restrict the freedom of movement of an individual in an instance when all of the following conditions are met: (i) there is an emergency; (ii) nonphysical interventions are not viable; and (iii) safety issues require an immediate response.

"Restraints for medical purposes" means using a physical hold, medication, or mechanical device to limit the mobility of an individual for medical, diagnostic, or surgical purposes, such as routine dental care or radiological procedures and related post-procedure care processes, when use of the restraint is not the accepted clinical practice for treating the individual's condition.

"Restraints for protective purposes" means using a mechanical device to compensate for a physical or cognitive deficit when the individual does not have the option to remove the device. The device may limit an individual's movement, for example, bed rails or a gerichair, and prevent possible harm to the individual or it may create a passive barrier, such as a helmet to protect the individual.

"Restriction" means anything that limits or prevents an individual from freely exercising his rights and privileges.

"Risk management" means an integrated system-wide program to ensure the safety of individuals, employees, visitors, and others through identification, mitigation, early detection, monitoring, evaluation, and control of risks.

"Root cause analysis" means a method of problem solving designed to identify the underlying causes of a problem. The focus of a root cause analysis is on systems, processes, and outcomes that require change to reduce the risk of harm.

"Screening" means the process or procedure for determining whether the individual meets the minimum criteria for initial assessment.

"Seclusion" means the involuntary placement of an individual alone in an area secured by a door that is locked or held shut by a staff person, by physically blocking the door, or by any other physical means so that the individual cannot leave the area.

"Serious incident" means any event or circumstance that causes or could cause harm to the health, safety, or well-being of an individual. The term "serious incident" includes death and serious injury.

"Level I serious incident" means a serious incident that occurs or originates during the provision of a service or on the premises of the provider and does not meet the definition of a Level II or Level III serious incident. Level I serious incidents do not result in significant harm to individuals but may include events that result in minor injuries that do not require medical attention or events that have the potential to cause serious injury, even when no injury occurs.

"Level II serious incident" means a serious incident that occurs or originates during the provision of a service or on the premises of the provider that results in a significant harm or threat to the health and safety of an individual that does not meet the definition of a Level III serious incident. "Level II serious incident" includes a significant harm or threat to the health or safety of others caused by an individual. Level II serious incidents include:

1. A serious injury;

2. An individual who is or was missing;

3. An emergency room visit;

4. An unplanned psychiatric or unplanned medical hospital admission of an individual receiving services other than licensed emergency services, except that a psychiatric admission in accordance with an individual's wellness plan shall not constitute an unplanned admission for the purposes of this chapter;

5. Choking incidents that require direct physical intervention by another person;

6. Ingestion of any hazardous material; or

7. A diagnosis of:

a. A decubitus ulcer or an increase in severity of level of previously diagnosed decubitus ulcer;

b. A bowel obstruction; or

c. Aspiration pneumonia.

"Level III serious incident" means a serious incident, whether or not the incident occurs while in the provision of a service or on the provider's premises, that results in:

1. Any death of an individual;

2. A sexual assault of an individual; or

3. A suicide attempt by an individual admitted for services, other than licensed emergency services, that results in a hospital admission.

"Serious injury" means any injury resulting in bodily hurt, damage, harm, or loss that requires medical attention by a licensed physician, doctor of osteopathic medicine, physician assistant, or nurse practitioner.

"Service" means, as defined by § 37.2-403 of the Code of Virginia, (i) planned individualized interventions intended to reduce or ameliorate mental illness, developmental disabilities, or substance abuse (substance use disorders) through care, treatment, training, habilitation, or other supports that are delivered by a provider to individuals with mental illness, developmental disabilities, or substance abuse (substance use disorders). Services include outpatient services, intensive in-home services, medication for opioid use disorder treatment services, inpatient psychiatric hospitalization, community gero-psychiatric residential services, assertive community treatment and other clinical services; day support, day treatment, partial hospitalization, psychosocial rehabilitation, and habilitation services; case management services; and supportive residential, special school, halfway house, in-home services, crisis stabilization, and other residential services; and (ii) planned individualized interventions intended to reduce or ameliorate the effects of brain injury through care, treatment, or other supports provided in residential services for persons with brain injury.

"Shall" means an obligation to act is imposed.

"Shall not" means an obligation not to act is imposed.

"Signed" or "signature" means a handwritten signature, an electronic signature, or a digital signature, as long as the signer showed clear intent to sign.

"Skills training" means systematic skill building through curriculum-based psychoeducational and cognitive-behavioral interventions. These interventions break down complex objectives for role performance into simpler components, including basic cognitive skills such as attention, to facilitate learning and competency.

"Sponsored residential home" means a service where providers arrange for, supervise, and provide programmatic, financial, and service support to families or persons (sponsors) providing care or treatment in their own homes for individuals receiving services.

"State opioid treatment authority" or "SOTA" means the Virginia Department of Behavioral Health and Developmental Services, which is authorized by the federal Center for Substance Abuse Treatment to exercise the responsibility and authority for governing the treatment of opioid use disorder with MOUD.

"Substance abuse (substance use disorders)" means, as defined by § 37.2-100 of the Code of Virginia, the use of drugs enumerated in the Virginia Drug Control Act (§ 54.1-3400 et seq.) without a compelling medical reason or alcohol that (i) results in psychological or physiological dependence or danger to self or others as a function of continued and compulsive use or (ii) results in mental, emotional, or physical impairment that causes socially dysfunctional or socially disordering behavior; and (iii), because of such substance abuse, requires care and treatment for the health of the individual. This care and treatment may include counseling, rehabilitation, or medical or psychiatric care.

"Substance abuse intensive outpatient service" or "Level of care 2.1" means structured treatment provided to individuals who require more intensive services than is normally provided in an outpatient service but do not require inpatient services. Treatment consists primarily of counseling and education about addiction-related and mental health challenges delivered a minimum of nine to 19 hours of services per week for adults or six to 19 hours of services per week for children and adolescents. Within this level of care an individual's needs for psychiatric and medical services are generally addressed through consultation and referrals.

"Substance abuse outpatient service" or "Level of care 1.0" means a center-based substance abuse treatment delivered to individuals for fewer than nine hours of service per week for adults or fewer than six hours per week for adolescents on an individual, group, or family basis. Substance abuse outpatient services may include diagnosis and evaluation, screening and intake, counseling, psychotherapy, behavior management, psychological testing and assessment, laboratory and other ancillary services, medical services, and medication services. Substance abuse outpatient service includes substance abuse services or an office practice that provides professionally directed aftercare, individual, and other addiction services to individuals according to a predetermined regular schedule of fewer than nine contact hours a week. Substance abuse outpatient service also includes:

1. Substance abuse services operated by a community services board or a behavioral health authority established pursuant to Chapter 5 (§ 37.2-500 et seq.) or Chapter 6 (§ 37.2-600 et seq.) of Title 37.2 of the Code of Virginia;

2. Substance abuse services contracted by a community services board or a behavioral health authority established pursuant to Chapter 5 (§ 37.2-500 et seq.) or Chapter 6 (§ 37.2-600 et seq.) of Title 37.2 of the Code of Virginia; or

3. Substance abuse services that are owned, operated, or controlled by a corporation organized pursuant to the provisions of either Chapter 9 (§ 13.1-601 et seq.) or Chapter 10 (§ 13.1-801 et seq.) of Title 13.1 of the Code of Virginia.

"Substance abuse partial hospitalization services" or "Level of care 2.5" means a short-term, nonresidential substance use treatment program provided for a minimum of 20 hours a week that uses multidisciplinary staff and is provided for individuals who require a more intensive treatment experience than intensive outpatient treatment but who do not require residential treatment. This level of care is designed to offer highly structured intensive treatment to those individuals whose condition is sufficiently stable so as not to require 24-hour-per-day monitoring and care, but whose illness has progressed so as to require consistent near-daily treatment intervention.

"Suicide attempt" means a nonfatal, self-directed, potentially injurious behavior with an intent to die as a result of the behavior regardless of whether it results in injury.

"Supervised living residential service" means the provision of significant direct supervision and community support services to individuals living in apartments or other residential settings. These services differ from supportive in-home service because the provider assumes responsibility for management of the physical environment of the residence, and staff supervision and monitoring are daily and available on a 24-hour basis. Services are provided based on the needs of the individual in areas such as food preparation, housekeeping, medication administration, personal hygiene, treatment, counseling, and budgeting.

"Supportive in-home service" (formerly supportive residential) means the provision of community support services and other structured services to assist individuals, to strengthen individual skills, and that provide environmental supports necessary to attain and sustain independent community residential living. Services include drop-in or friendly-visitor support and counseling to more intensive support, monitoring, training, in-home support, respite care, and family support services. Services are based on the needs of the individual and include training and assistance. These services normally do not involve overnight care by the provider; however, due to the flexible nature of these services, overnight care may be provided on an occasional basis.

"Systemic deficiency" means violations of regulations documented by the department that demonstrate multiple or repeat defects in the operation of one or more services.

"Telehealth" shall have the same meaning as "telehealth services" in § 32.1-122.03:1 of the Code of Virginia.

"Telemedicine" shall have the same meaning as "telemedicine services" in § 38.2-3418.16 of the Code of Virginia.

"Therapeutic day treatment for children and adolescents" means a treatment program that serves (i) children and adolescents from birth through 17 years of age and under certain circumstances up to 21 years of age with serious emotional disturbances, substance use, or co-occurring disorders or (ii) children from birth through seven years of age who are at risk of serious emotional disturbance, in order to combine psychotherapeutic interventions with education and mental health or substance abuse treatment. Services include: evaluation; medication education and management; opportunities to learn and use daily living skills and to enhance social and interpersonal skills; and individual, group, and family counseling.

"Time out" means the involuntary removal of an individual by a staff person from a source of reinforcement to a different, open location for a specified period of time or until the problem behavior has subsided to discontinue or reduce the frequency of problematic behavior.

"Volunteer" means a person who, without financial remuneration, provides services to individuals on behalf of the provider.

"Withdrawal management" means the dispensing of MOUD in decreasing doses to an individual to alleviate adverse physical effects incident to withdrawal from the continuous or sustained use of an opioid and as a method of bringing the individual to an opioid-free state within such a period. Long-term withdrawal management refers to the process of medication tapering that exceeds 30 days.

"Written," "writing," and "in writing" include any representation of words, letters, symbols, numbers, or figures, whether (i) printed or inscribed on a tangible medium or (ii) stored in an electronic or other medium and retrievable in a perceivable form and whether an electronic signature authorized by Chapter 42.1 (§ 59.1-479 et seq.) of Title 59.1 of the Code of Virginia is or is not affixed.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 19, Issue 24, eff. September 18, 2003; Volume 23, Issue 10, eff. February 21, 2007; Volume 28, Issue 5, eff. December 7, 2011; Volume 35, Issue 4, eff. November 29, 2018; Volume 35, Issue 10, eff. February 21, 2019; Volume 35, Issue 19, eff. June 15, 2019; Errata, 36:5 VA.R. 421 October 28, 2019; amended, Virginia Register Volume 36, Issue 22, eff. August 1, 2020; Volume 39, Issue 11, eff. February 17, 2023; Volume 40, Issue 22, eff. July 17, 2024; Errata, 40:24 VA.R 1990 July 15, 2024; amended, Virginia Register Volume 41, Issue 5, eff. December 5, 2024; Volume 41, Issue 20, eff. June 18, 2025; Volume 42, Issue 3, eff. December 1, 2025.

12VAC35-105-30 Licenses

A. Licenses are issued to providers who offer services to individuals who have mental illness, a developmental disability, or substance abuse (substance use disorders) or have brain injury and are receiving residential services.

B. Providers shall be licensed to provide specific services as defined in this chapter or as determined by the commissioner. These services include:

1. Assertive community treatment (ACT);

2. Case management;

3. Clinically managed high-intensity residential care or Level of care 3.5;

4. Clinically managed low-intensity residential care or Level of care 3.1;

5. Clinically managed population specific high-intensity residential or Level of care 3.3;

6. Community gero-psychiatric residential;

7. Community-based crisis stabilization;

8. Crisis receiving center;

9. Crisis stabilization unit;

10. Day support;

11. Day treatment, including therapeutic day treatment for children and adolescents;

12. Group home and community residential;

13. ICF/IID;

14. Inpatient psychiatric;

15. Intensive in-home;

16. Medically managed intensive inpatient service or Level of care 4.0;

17. Medically monitored intensive inpatient treatment or Level of care 3.7;

18. Medication for opioid use disorder treatment;

19. Mental health community support;

20. Mental health intensive outpatient;

21. Mental health outpatient;

22. Mental health partial hospitalization;

23. Psychosocial rehabilitation;

24. REACH CTH;

25. REACH mobile crisis response;

26. Residential treatment;

27. Respite care;

28. Sponsored residential home;

29. Substance abuse intensive outpatient;

30. Substance abuse outpatient;

31. Substance abuse partial hospitalization;

32. Supervised living residential; and

33. Supportive in-home.

C. A license addendum shall describe the services licensed, the disabilities of individuals who may be served, the specific locations where services are to be provided or administered, and the terms and conditions for each service offered by a licensed provider. For residential and inpatient services, the license identifies the number of individuals each residential location may serve at a given time.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 19, Issue 24, eff. September 18, 2003; Volume 23, Issue 10, eff. February 21, 2007; Volume 28, Issue 5, eff. December 7, 2011; Volume 39, Issue 11, eff. February 17, 2023; Errata, 39:14 VA.R. 2041 February 27, 2023; amended, Virginia Register Volume 40, Issue 22, eff. July 17, 2024; Volume 42, Issue 3, eff. December 1, 2025.

12VAC35-105-40 Application requirements

A. All providers that are not currently licensed shall be required to apply for a license using the application designated by the commissioner. Providers applying for a license shall submit:

1. A working budget showing projected revenue and expenses for the first year of operation, including a revenue plan.

2. Documentation of working capital to include:

a. Funds or a line of credit sufficient to cover at least 90 days of operating expenses if the provider is a corporation, unincorporated organization or association, a sole proprietor, or a partnership.

b. Appropriated revenue if the provider is a state or local government agency, board or commission.

3. Documentation of authority to conduct business in the Commonwealth of Virginia.

4. A disclosure statement identifying the legal names and dates of any services licensed in Virginia or other states that the applicant holds or has held, previous sanctions or negative actions against any license to provide services that the applicant holds or has held in any other state or in Virginia, and the names and dates of any disciplinary actions involving the applicant's current or past licensed services.

B. Providers shall submit an application listing each service to be provided and submit the following items for each service:

1. A staffing plan;

2. Employee credentials and job descriptions containing all the elements outlined in 12VAC35-105-410 A;

3. A service description containing all the elements outlined in 12VAC35-105-580 C; and

4. Records management policy containing all the elements outlined in 12VAC35-105-390 and 12VAC35-105-870 A.

C. The provider shall confirm his intent to renew the license prior to the expiration date of the license and notify the department in advance of any changes in service or location.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September. 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-50 Issuance of licenses

A. The commissioner may issue the following types of licenses:

1. A conditional license may be issued to a new provider for services that demonstrates compliance with administrative and policy regulations but has not demonstrated compliance with all the regulations.

a. A conditional license shall not exceed six months.

b. A conditional license may be renewed if the provider is not able to demonstrate compliance with all the regulations at the end of the license period. A conditional license and any renewals shall not exceed 12 successive months for all conditional licenses and renewals combined.

c. A provider holding a conditional license for a service shall demonstrate progress toward compliance.

d. A provider holding a conditional license shall not add services or locations during the conditional period.

e. A group home or community residential service provider shall be limited to providing services in a single location, serving no more than four individuals during the conditional period.

2. A provisional license may be issued to a provider for a service that has demonstrated an inability to maintain compliance with all applicable regulations, including this chapter and 12VAC35-115, has violations of human rights or licensing regulations that pose a threat to the health or safety of individuals receiving services, has multiple violations of human rights or licensing regulations, or has failed to comply with a previous corrective action plan.

a. A provisional license may be issued at any time.

b. The term of a provisional license shall not exceed six months.

c. A provisional license may be renewed; but a provisional license and any renewals shall not exceed 12 successive months for all provisional licenses and renewals combined.

d. A provider holding a provisional license for a service shall demonstrate progress toward compliance.

e. A provider holding a provisional license for a service shall not increase its services or locations or expand the capacity of the service.

f. A provisional license for a service shall be noted as a stipulation on the provider license. The stipulation shall also indicate the violations to be corrected and the expiration date of the provisional license.

3. A full license shall be issued after a provider or service demonstrates compliance with all the applicable regulations.

a. A full license may be granted to a provider for service for up to three years. The length of the license shall be in the sole discretion of the commissioner.

b. If a full license is granted for three years, it shall be referred to as a triennial license. A triennial license shall be granted to providers for services that have demonstrated full compliance with all applicable regulations. The commissioner may issue a triennial license to a provider for service that had violations during the previous license period if those violations did not pose a threat to the health or safety of individuals receiving services, and the provider or service has demonstrated consistent compliance for more than a year and has a process in place that provides sufficient oversight to maintain compliance.

c. If a full license is granted for one year, it shall be referred to as an annual license.

d. The term of the first full renewal license after the expiration of a conditional or provisional license shall not exceed one year.

B. The commissioner may add stipulations on a license issued to a provider that may place limits on the provider or to impose additional requirements on the provider.

C. A license shall not be transferred or assigned to another provider. A new application shall be made and a new license issued when there is a change in ownership.

D. No service shall be issued a license with an expiration date that is after the expiration date of the provider license.

E. A license shall continue in effect after the expiration date if the provider has submitted a renewal application before the date of expiration and there are no grounds to deny the application. The department shall issue a letter stating the provider or service license shall be effective for six additional months if the renewed license is not issued before the date of expiration.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 36, Issue 22, eff. August 1, 2020.

12VAC35-105-60 Modification

A. A provider shall submit a written service modification application at least 30 days in advance of a proposed modification to the provider's license. The modification may address the characteristics of individuals served (e.g., disability, age, or gender), the services offered, the locations where services are provided, existing stipulations, or the maximum number of individuals served under the provider license.

B. Upon receipt of the completed service modification application, the commissioner may revise the provider license. Approval of such request shall be at the sole discretion of the commissioner.

C. A change requiring a modification of the license shall not be implemented prior to approval by the commissioner. The department may send the provider a letter approving implementation of the modification pending the issuance of the modified license.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-70 Onsite reviews

A. The department shall conduct an announced or unannounced onsite review of all new providers and services to determine compliance with this chapter.

B. The department shall conduct unannounced onsite reviews of licensed providers and each service at any time and at least annually to determine compliance with these regulations. The annual unannounced onsite reviews shall be focused on preventing specific risks to individuals, including an evaluation of the physical facilities in which the services are provided.

C. The department may conduct announced and unannounced onsite reviews at any time as part of the investigations of complaints or incidents to determine if there is a violation of this chapter.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-80 Complaint investigations

The department shall investigate all complaints regarding potential violations of licensing regulations. Complaint investigations may be based on onsite reviews, a review of records, a review of provider reports or telephone interviews.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002.

12VAC35-105-90 Compliance

A. The department shall determine the level of compliance with each regulation as follows:

1. "Compliance" (C) means the provider clearly meets the requirements of a regulation.

2. "Noncompliance" (NC) means the provider violates or fails to meet part or all of a regulation.

3. "Not Determined" (ND) means that the provider must provide additional information to determine compliance with a regulation.

4. "Not Applicable" (NA) means the provider is specifically exempted from or not required to demonstrate compliance with the provisions of a regulation.

B. The provider, including its employees, contract service providers, student interns, and volunteers, shall comply with all applicable regulations.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-100 Sanctions

A. The commissioner may invoke the sanctions enumerated in § 37.2-419 of the Code of Virginia upon receipt of information that a licensed provider is:

1. In violation of the provisions of §§ 37.2-400 through 37.2-422 of the Code of Virginia, these regulations, or the provisions of the Rules and Regulations to Assure the Rights of Individuals Receiving Services from Providers Licensed, Funded, or Operated by the Department of Behavioral Health and Developmental Services (12VAC35-115); and

2. Such violation adversely affects the human rights of individuals, or poses an imminent and substantial threat to the health, safety or welfare of individuals.

The commissioner shall notify the provider in writing of the specific violations found and of his intention to convene an informal conference pursuant to § 2.2-4019 of the Code of Virginia at which the presiding officer will be asked to recommend issuance of a special order.

B. The sanctions contained in the special order shall remain in effect during the pendency of any appeal of the special order.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-110 Denial, revocation, or suspension of a license

A. An application for a license or license renewal may be denied and a full, conditional, or provisional license may be revoked or suspended for one or more of the following reasons:

1. The provider or applicant has violated any provisions of Article 2 (§ 37.2-403 et seq.) of Chapter 4 of Title 37.2 of the Code of Virginia or these licensing regulations;

2. The provider's or applicant's conduct or practices are detrimental to the welfare of any individual receiving services or in violation of human rights identified in § 37.2-400 of the Code of Virginia or the human rights regulations (12VAC35-115);

3. The provider or applicant permits, aids, or abets the commission of an illegal act;

4. The provider or applicant fails or refuses to submit reports or to make records available as requested by the department;

5. The provider or applicant refuses to admit a representative of the department who displays a state-issued photo identification to the premises;

6. The provider or applicant fails to submit or implement an adequate corrective action plan; or

7. The provider or applicant submits any misleading or false information to the department.

B. A provider shall be notified in writing of the department's intent to deny, revoke, or suspend a license; the reasons for the action; the right to appeal; and the appeal process. The provider has the right to appeal the department's decision under the provisions of the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-115 Summary suspension

A. In conjunction with any proceeding for revocation, denial , or other action, when conditions or practices exist that pose an immediate and substantial threat to the health, safety, and welfare of the individuals living there, the commissioner may issue an order of summary suspension of the license to operate any group home or residential service for adults when he believes the operation of the home or residential service should be suspended during the pendency of such proceeding.

B. Prior to the issuance of an order of summary suspension, the department shall contact the Executive Secretary of the Supreme Court of Virginia to obtain the name of a hearing officer. The department shall schedule the time, date, and location of the administrative hearing with the hearing officer.

C. The order of summary suspension shall take effect upon its issuance. It shall be delivered by personal service and certified mail, return receipt requested, to the address of record of the licensee as soon as practicable. The order shall set forth:

1. The time, date, and location of the hearing;

2. The procedures for the hearing;

3. The hearing and appeal rights; and

4. Facts and evidence that formed the basis for the order of summary suspension.

D. The hearing shall take place within three business days of the issuance of the order of summary suspension.

E. The department shall have the burden of proving in any summary suspension hearing that it had reasonable grounds to require the licensee to cease operations during the pendency of the concurrent revocation, denial, or other proceeding.

F. The administrative hearing officer shall provide written findings and conclusions together with a recommendation as to whether the license should be summarily suspended to the commissioner within five business days of the hearing.

G. The commissioner shall issue a final order of summary suspension or make a determination that the summary suspension is not warranted based on the facts presented and the recommendation of the hearing officer within seven business days of receiving the recommendation of the hearing officer.

H. The commissioner shall issue and serve on the group home or residential facility for adults or its designee by personal service or by certified mail, return receipt requested either:

1. A final order of summary suspension including (i) the basis for accepting or rejecting the hearing officer's recommendation, and (ii) notice that the licensee of the group home or residential service may appeal the commissioner's decision to the appropriate circuit court no later than 10 days following issuance of the order; or

2. Notification that the summary suspension is not warranted by the facts and circumstances presented and that the order of summary suspension is rescinded.

I. The licensee may appeal the commissioner's decision on the summary suspension to the appropriate circuit court no more than 10 days after issuance of the final order.

J. The outcome of concurrent revocation, denial, and other proceedings shall not be affected by the outcome of any hearing pertaining to the appropriateness of the order of summary suspension.

K. At the time of the issuance of the order of summary suspension, the department shall contact the appropriate agencies to inform them of the action and the need to develop relocation plans for the individuals receiving residential or center-based services, and ensure that any other legal guardians or responsible family members are informed of the pending action.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia
• Historical Notes: Derived from Virginia Register Volume 24, Issue 11, eff. March 5, 2008; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-120 Variances

The commissioner may grant a variance to a specific regulation if he determines that such a variance will not jeopardize the health, safety, or welfare of individuals. A provider shall submit a request for such variance in writing to the commissioner. The request shall demonstrate that the variance will not jeopardize the health, safety, or welfare of individuals. The department may limit the length of time a variance will be effective. The provider shall not implement a variance until it has been approved in writing by the commissioner.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 36, Issue 22, eff. August 1, 2020; Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-130 Confidentiality of records

Records that are confidential under federal or state law shall be maintained as confidential by the department and shall not be further disclosed except as required or permitted by law.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

Article 1 Management and Administration

12VAC35-105-140 License availability

The current license or a copy shall be prominently displayed for public inspection in all service locations.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-150 Compliance with applicable laws, regulations and policies

The provider including its employees, contractors, students, and volunteers shall comply with:

1. This chapter;

2. The terms and stipulations of the license;

3. All applicable federal, state, or local laws and regulations including:

a. Laws regarding employment practices including the Equal Employment Opportunity Act;

b. The Americans with Disabilities Act and the Virginians with Disabilities Act;

c. For home and community-based services waiver settings subject to this chapter, 42 CFR 441.301(c)(1) through (4);

d. Occupational Safety and Health Administration regulations;

e. Virginia Department of Health regulations;

f. Virginia Department of Health Professions regulations;

g. Virginia Department of Medical Assistance Services regulations;

h. Uniform Statewide Building Code; and

i. Uniform Statewide Fire Prevention Code.

4. Section 37.2-400 of the Code of Virginia and related human rights regulations adopted by the state board; and

5. The provider's own policies. All required policies shall be in writing.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 36, Issue 22, eff. August 1, 2020.

12VAC35-105-155 Preadmission-screening, discharge planning, involuntary commitment, and mandatory outpatient treatment orders

A. Providers responsible for complying with §§ 37.2-505 and 37.2-606 of the Code of Virginia regarding community services board and behavioral health authority preadmission screening and discharge planning shall implement policies and procedures that include:

1. Identification, qualification, training, and responsibilities of employees responsible for preadmission screening and discharge planning.

2. Completion of a discharge plan prior to an individual's discharge in consultation with the state facility that:

a. Involves the individual or his authorized representative and reflects the individual's preferences to the greatest extent possible consistent with the individual's needs.

b. Involves mental health, developmental disability, substance abuse, social, educational, medical, employment, housing, legal, advocacy, transportation, and other services that the individual will need upon discharge into the community and identifies the public or private agencies or persons that have agreed to provide them.

B. Any provider who serves individuals through an emergency custody order, temporary detention order, or mandatory outpatient treatment order shall implement policies and procedures to comply with §§ 37.2-800 through 37.2-817 of the Code of Virginia.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011; amended, Virginia Register Volume 36, Issue 22, eff. August 1, 2020.

12VAC35-105-160 Reviews by the department; requests for information; required reporting

A. The provider shall permit representatives from the department to conduct reviews to:

1. Verify application information;

2. Assure compliance with this chapter; and

3. Investigate complaints.

B. The provider shall cooperate fully with inspections and investigations and shall provide all information requested by the department.

C. The provider shall collect, maintain, and review at least quarterly all serious incidents, including Level I serious incidents, as part of the quality improvement program in accordance with 12VAC35-105-620 to include an analysis of trends, potential systemic issues or causes, indicated remediation, and documentation of steps taken to mitigate the potential for future incidents.

D. The provider shall collect, maintain, and report or make available to the department the following information:

1. Each allegation of abuse or neglect shall be reported to the department as provided in 12VAC35-115-230 A.

2. Level II and Level III serious incidents shall be reported using the department's web-based reporting application and by telephone or email to anyone designated by the individual to receive such notice and to the individual's authorized representative within 24 hours of discovery. Reported information shall include the information specified by the department as required in its web-based reporting application, but at least the following: the date, place, and circumstances of the serious incident. For serious injuries and deaths, the reported information shall also include the nature of the individual's injuries or circumstances of the death and any treatment received. For all other Level II and Level III serious incidents, the reported information shall also include the consequences that resulted from the serious incident. Deaths that occur in a hospital as a result of illness or injury occurring when the individual was in a licensed service shall be reported.

3. Instances of seclusion or restraint shall be reported to the department as provided in 12VAC35-115-230 C 4.

E. A root cause analysis shall be conducted by the provider within 30 days of discovery of Level II serious incidents and any Level III serious incidents that occur during the provision of a service or on the provider's premises.

1. The root cause analysis shall include at least the following information:

a. A detailed description of what happened;

b. An analysis of why it happened, including identification of all identifiable underlying causes of the incident that were under the control of the provider; and

c. Identified solutions to mitigate its reoccurrence and future risk of harm when applicable.

2. The provider shall develop and implement a root cause analysis policy for determining when a more detailed root cause analysis, including convening a team, collecting and analyzing data, mapping processes, and charting causal factors, should be conducted. At a minimum, the policy shall require for the provider to conduct a more detailed root cause analysis when:

a. A threshold number, as specified in the provider's policy based on the provider's size, number of locations, service type, number of individuals served, and the unique needs of the individuals served by the provider, of similar Level II serious incidents occur to the same individual or at the same location within a six-month period;

b. Two or more of the same Level III serious incidents occur to the same individual or at the same location within a six-month period;

c. A threshold number, as specified in the provider's policy based on the provider's size, number of locations, service type, number of individuals served, and the unique needs of the individuals served by the provider, of similar Level II or Level III serious incidents occur across all of the provider's locations within a six-month period; or

d. A death occurs as a result of an acute medical event that was not expected in advance or based on a person's known medical condition.

F. The provider shall make available and, when requested, submit reports and information that the department requires to establish compliance with these regulations and applicable statutes.

G. Records that are confidential under federal or state law shall be maintained as confidential by the department and shall not be further disclosed except as required or permitted by law; however, there shall be no right of access to communications that are privileged pursuant to § 8.01-581.17 of the Code of Virginia.

H. Additional information requested by the department if compliance with a regulation cannot be determined shall be submitted within 10 business days of the issuance of the licensing report requesting additional information. Extensions may be granted by the department when requested prior to the due date, but extensions shall not exceed an additional 10 business days.

I. Applicants and providers shall not submit any misleading or false information to the department.

J. The provider shall develop and implement a serious incident management policy, which shall be consistent with this section and which shall describe the processes by which the provider will document, analyze, and report to the department information related to serious incidents.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 36, Issue 22, eff. August 1, 2020.

12VAC35-105-170 Corrective action plan

A. If there is noncompliance with any applicable regulation during an initial or ongoing review, inspection, or investigation, the department shall issue a licensing report describing the noncompliance and requesting the provider to submit a corrective action plan for each violation cited.

B. The provider shall submit to the department a written corrective action plan for each violation cited.

C. The corrective action plan shall include a:

1. Detailed description of the corrective actions to be taken that will minimize the possibility that the violation will occur again and correct any systemic deficiencies;

2. Date of completion for each corrective action; and

3. Responsible person designated to oversee implementation of the pledged corrective action.

D. The provider shall submit a corrective action plan to the department within 15 business days of the issuance of the licensing report. One extension may be granted by the department when requested prior to the due date, but extensions shall not exceed an additional 10 business days. An immediate corrective action plan shall be required if the department determines that the violations pose a danger to individuals receiving the service.

E. Upon receipt of the corrective action plan, the department shall review the plan and determine whether the plan is approved or not approved. The provider has an additional 10 business days to submit a revised corrective action plan after receiving a notice that the department has not approved the revised plan.

F. If a provider disagrees with a citation of a violation or the disapproval of a revised corrective action plan, the provider shall discuss this disagreement with the licensing specialist initially. If the disagreement is not resolved, the provider may ask for a meeting with the licensing specialist's supervisor, in consultation with the director of licensing, to challenge a finding of noncompliance. The determination of the director is final.

G. The provider shall implement an approved written corrective action plan for each violation cited by the date of completion identified in the plan.

H. The provider shall monitor implementation and effectiveness of approved corrective actions as part of its quality improvement program required by 12VAC35-105-620. If the provider determines that an approved corrective action was fully implemented, but did not prevent the recurrence of a regulatory violation or correct any systemic deficiencies, the provider shall:

1. Continue implementing the corrective action plan and put into place additional measures to prevent the recurrence of the cited violation and address identified systemic deficiencies; or

2. Submit a revised corrective action plan to the department for approval.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 36, Issue 22, eff. August 1, 2020; Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-180 Notification of changes

A. The provider shall notify the department in writing prior to implementing changes that affect significant changes to the staffing plan, position descriptions, or employee or contractor qualifications.

B. A provider shall notify the department in writing of its intent to discontinue services at least 30 days prior to the cessation of services. The provider shall continue to provide all services that are identified in each individual's ISP after it has given official notice of its intent to cease operations and until each individual is appropriately discharged in accordance with 12VAC35-105-693. The provider shall further continue to maintain substantial compliance with all applicable regulations as it discontinues its services.

C. All individuals receiving services and their authorized representatives shall be notified of the provider's intent to cease services in writing at least 30 days prior to the cessation of services.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-190 Operating authority, governing body and organizational structure

A. The provider shall provide the following evidence of its operating authority:

1. Public organizations shall provide documents describing the administrative framework of the governmental department of which the organization is a component or describing the legal and administrative framework under which the organization was established and operates.

2. All private organizations, except sole proprietors trading under the proprietor's own name shall provide a certificate from the State Corporation Commission pursuant to § 59.1-69 of the Code of Virginia.

B. The provider shall provide an organizational chart that clearly identifies the provider's governing body and organizational structure.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-200 Appointment of administrator

The provider shall appoint qualified persons to whom it delegates, in writing, the authority and responsibility for the administrative direction and day-to-day operation of the provider and its services.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002.

12VAC35-105-210 Fiscal accountability

A. The provider shall document financial arrangements or a line of credit that are adequate to ensure maintenance of ongoing operations for at least 90 days on an ongoing basis. The amount needed shall be based on a working budget showing projected revenue and expenses.

B. In addition to the indemnity coverage required pursuant to 12VAC35-105-220, the provider shall have written internal controls to minimize the risk of theft or embezzlement of provider funds.

C. The provider shall identify in writing the title and qualifications of the person with the authority and responsibility for the fiscal management of the provider's services.

D. The provider shall notify the department in writing when the provider's line of credit or other financial arrangement has been cancelled or significantly reduced at any time during the licensing period.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-220 Indemnity coverage

To protect the interests of individuals, employees, and the provider from risks of liability, there shall be indemnity coverage to include:

1. General liability;

2. Professional liability;

3. Commercial vehicular liability; and

4. Property damage.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-230 Written fee schedule

If the provider charges for services, the written schedule of rates and charges shall be available to the individual or authorized representative upon request.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-240 Policy on funds of individuals receiving services

A. The provider shall implement a policy for handling funds of individuals receiving services, including providing for separate accounting of individual funds.

B. The provider shall have documented financial controls to minimize the risk of theft or embezzlement of funds of individuals receiving services.

C. The provider shall purchase a surety bond or otherwise provide assurance for the security of all funds of individuals receiving services deposited with the provider.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-250 Deceptive or false advertising

A. The provider shall not use any advertising that contains false, misleading or deceptive statements or claims, or false or misleading disclosure of fees and payment for services.

B. The provider's name and service names shall not imply the provider is offering services for which it is not licensed.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002.

Article 2 Physical Environment

12VAC35-105-260 Building inspection and classification

All locations shall be inspected and approved as required by the appropriate building regulatory entity. Documentation of approval shall be a Certificate of Use and Occupancy indicating the building is classified for its proposed licensed purpose. The provider shall submit a copy of the Certificate of Use and Occupancy to the department for new locations. This section does not apply to correctional facilities or home and noncenter-based services. Sponsored residential service providers shall certify that their sponsored residential homes comply with this regulation.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-265 Floor plans

All services shall submit floor plans with room dimensions to the department for new locations. This does not apply to home or noncenter-based services.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-270 Building modifications

The provider shall submit a plan to the department addressing safety and continued service delivery for any planned construction involving (i) changes in the use of existing locations or (ii) structural modifications to new or existing buildings. This section does not apply to correctional facilities, jails, or home-based and noncenter-based services.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-280 Physical environment

A. The physical environment, design, structure, furnishings, and lighting shall be appropriate and safe for the individuals served and the services provided.

B. The physical environment shall be accessible to individuals with physical and sensory disabilities, if applicable.

C. The physical environment and furnishings shall be clean, dry, free of foul odors, safe, and well-maintained.

D. Floor surfaces and floor coverings shall promote mobility in areas used by individuals and shall promote maintenance of sanitary conditions.

E. The physical environment shall be well ventilated. Temperatures shall be maintained between 65°F and 80°F in all areas used by individuals.

F. Adequate hot and cold running water of a safe and appropriate temperature shall be available. Hot water accessible to individuals being served shall be maintained within a range of 100° to 120°F. If temperatures cannot be maintained within the specified range, the provider shall make provisions for protecting individuals from injury due to scalding.

G. Recycling, composting, and garbage disposal shall not create a nuisance, permit transmission of disease, or create a breeding place for insects or rodents.

H. If smoking is permitted, the provider shall make provisions for alternate smoking areas that are separate from the service environment.

I. For all program areas added after September 19, 2002, minimum room height shall be 7-1/2 feet.

J. This section does not apply to home-based and noncenter-based or crisis services. Sponsored residential services shall certify compliance of sponsored residential homes with this section.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 19, Issue 24, eff. September 18, 2003; Volume 28, Issue 5, eff. December 7, 2011; Volume 40, Issue 22, eff. July 17, 2024; Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-290 Food service inspections

A. Any location where the provider is responsible for preparing or serving food shall request inspection and shall obtain approval by state or local health authorities regarding food service and general sanitation at the time of the original application and annually thereafter in accordance with Food Regulations (12VAC5-421).

B. Documentation of the most recent inspection and approval shall be kept on file. This section does not apply to sponsored residential services or to group homes or community residential homes.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-300 Sewer and water inspections

A. Service locations shall be on a public water and sewage system or on a nonpublic water and sewage system. Prior to a location being licensed, the provider shall obtain the report from the building inspector pertaining to the septic system and its capacity. Nonpublic water and sewer systems shall be maintained in good working order and in compliance with local and state laws. Providers of sponsored residential home services shall certify that their sponsored residential homes comply with this section.

B. Service locations that are not on a public water system shall have a water sample tested prior to being licensed and annually by an accredited, independent laboratory for the absence of coliform. The water sample shall also be tested for lead or nitrates if recommended by the local health department. Documentation of the three most recent inspections shall be kept on file.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-310 Weapons

The provider or facility shall have and implement a written policy governing the use and possession of firearms, pellet guns, air rifles, and other weapons on the premises, including parking areas, of the provider's services. The policy shall provide that no firearms, pellet guns, air rifles, and other weapons shall be permitted unless the weapons are:

1. In the possession of licensed security or sworn law-enforcement personnel;

2. Kept securely under lock and key; or

3. Used under the supervision of a responsible adult in accordance with policies and procedures developed by the provider for the weapons' lawful and safe use.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-320 Fire inspections

The provider shall document at the time of its original application and annually thereafter that buildings and equipment in residential service locations serving more than eight individuals are maintained in accordance with the Virginia Statewide Fire Prevention Code (13VAC5-52). This section does not apply to correctional facilities.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 36, Issue 22, eff. August 1, 2020; Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-325 Community liaison

Each residential service shall designate a staff person as a community liaison responsible for facilitating cooperative relationships with neighbors, local law-enforcement personnel, local government officials, and the community at large.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

Article 3 Physical Environment of Residential and Inpatient Service Locations

12VAC35-105-330 Beds

A. The provider shall not operate more beds than the number for which its service location is licensed.

B. An ICF/IID may not have more than 12 beds at any one location. This applies to new applications for services and not to existing services or locations licensed prior to December 7, 2011.

C. This section does not apply to crisis services as crisis services shall comply with Part VIII of this chapter.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 36, Issue 22, eff. August 1, 2020; Volume 40, Issue 22, eff. July 17, 2024.

12VAC35-105-340 Bedrooms

A. Bedrooms shall meet the following square footage requirements:

1. Single occupancy bedrooms shall have no less than 80 square feet of floor space.

2. Multiple occupancy bedrooms shall have no less than 60 square feet of floor space per individual.

3. This subsection does not apply to community gero-psychiatric residential services.

B. No more than four individuals shall share a bedroom, except in group homes where no more than two individuals shall share a room. This does not apply to group home locations licensed prior to December 7, 2011.

C. Each individual shall have adequate private storage space accessible to the bedroom for clothing and personal belongings.

D. This section does not apply to correctional facilities and jails or crisis services. Providers of sponsored residential home services shall certify that their sponsored residential homes comply with this section.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 40, Issue 22, eff. July 17, 2024.

12VAC35-105-350 Condition of beds

A. Beds shall be clean, comfortable, and equipped with a mattress, pillow, blankets, and bed linens. When a bed is soiled, providers shall assist individuals with bathing as needed, and provide clean clothing and bed linens. Providers of sponsored residential home services shall certify that their sponsored residential homes comply with this section.

B. This section does not apply to crisis services as crisis services shall comply with Part VIII of this chapter.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 40, Issue 22, eff. July 17, 2024.

12VAC35-105-360 Privacy

A. Bedroom and bathroom windows and doors shall provide privacy.

B. Bathrooms intended for use by more than one individual at the same time shall provide privacy for showers and toilets.

C. No required path of travel to the bathroom shall be through another bedroom.

D. This section does not apply to correctional facilities and jails or crisis services. Providers of sponsored residential home services shall certify that their sponsored residential homes comply with this section.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 40, Issue 22, eff. July 17, 2024.

12VAC35-105-370 Ratios of toilets, basins, and showers or baths

For all residential and inpatient locations established, constructed, or reconstructed after January 13, 1995, there shall be at least one toilet, one hand basin, and shower or bath for every four individuals. This section does not apply to correctional facilities or jails or crisis services. Providers of sponsored residential home services shall certify that their sponsored residential homes comply with this section.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 40, Issue 22, eff. July 17, 2024.

12VAC35-105-380 Lighting

Each service location shall have adequate lighting in halls and bathrooms at night. This section does not apply to crisis services as crisis services shall comply with Part VIII of this chapter. Providers of sponsored residential home services shall certify that their sponsored residential homes comply with this section.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 40, Issue 22, eff. July 17, 2024.

Article 4 Human Resources

12VAC35-105-390 Confidentiality and security of personnel records

A. The provider shall maintain an organized system to manage and protect the confidentiality of personnel files and records.

B. Providers shall comply with requirements of the Americans with Disabilities Act (42 USC § 12101 et seq.) and the Virginians with Disabilities Act (§ 51.5-1 et seq. of the Code of Virginia) regarding retention of employee health-related information in a file separate from personnel files.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-400 Criminal background checks and registry searches

A. Providers shall comply with the requirements for obtaining criminal history background checks as outlined in §§ 37.2-416, 37.2-416.1, 37.2-506, 37.2-506.1, and 37.2-607 of the Code of Virginia.

B. The provider shall develop a written policy for criminal history background checks and registry searches that addresses what actions the provider must take if an applicant has certain prior convictions or a founded case of child abuse or neglect. The policy shall require, at a minimum, that the applicant disclose whether the applicant has (i) ever been convicted of or is the subject of pending charges for an offense listed in § 37.2-416, 37.2-416.1, 37.2-506, 37.2-506.1, or 37.2-607 of the Code of Virginia; or (ii) has a founded case of abuse or neglect. Any plea of nolo contendere shall be considered a conviction for purposes of this section.

C. The provider shall submit all personally descriptive applicant information necessary to complete the criminal history background checks and registry searches.

D. The provider shall maintain the following documentation:

1. The disclosure statement from the applicant required pursuant to subsection B of this section; and

2. Evidence that the provider submitted all information necessary to complete the criminal history background checks and registry searches, report from the Central Criminal Records Exchange, or memoranda from the department transmitting the results to the provider, as applicable, and the results from the Child Protective Registry search.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 36, Issue 22, eff. August 1, 2020; Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-410 Job description

Each employee or contractor shall have access to the employee's or contractor's current written job description that includes:

1. Job title;

2. Duties and responsibilities; and

3. Minimum knowledge, skills, and abilities; education or training; or experience or professional qualifications required for entry.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-420 Qualifications of employees or contractors

A. Each person who assumes the responsibilities of a position as an employee or a contractor shall meet the minimum qualifications of that position in accordance with the current job description.

B. Employees and contractors shall comply, as required, with the regulations of the Department of Health Professions. The provider shall design, implement, and document the process used to verify professional credentials.

C. Each employee or contractor shall demonstrate a working knowledge of the policies and procedures that are applicable to that employee's or contractor's specific job or position.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-430 Employee or contractor personnel records

A. Employee or contractor personnel records shall include:

1. Individual identifying information;

2. Education and training history;

3. Employment history; and

4. A record of disciplinary action taken by the provider, if any.

B. Each employee or contractor personnel record shall be retained in its entirety for a minimum of three years after the employee's or contractor's termination of employment.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-435 Provision of provider statement to any other provider

Providers shall give a statement in writing regarding a current or past employee or other individual currently or previously associated with the provider in a capacity that requires a criminal history background check pursuant to § 37.2-416 or 37.2-506 of the Code of Virginia to any other licensed provider with which the current or past employee has applied for employment or to fill a role that requires a criminal history background check pursuant to § 37.2-416 or 37.2-506 of the Code of Virginia. The statement shall address the character, ability, and fitness for employment in or to otherwise fill the role for which the person has applied and shall be provided upon:

1. Receipt of a request for such information from the other licensed provider; and

2. Written consent to the disclosure of such information executed by the current or past employee or other individual currently or previously associated with the provider in a capacity that requires a criminal history background check pursuant to § 37.2-416 or 37.2-506 of the Code of Virginia.

Nothing in this provision shall require disclosure of information subject to privilege or confidentiality pursuant to § 8.01-581.16, 8.01-581.17, or 32.1-127.1:03 of the Code of Virginia or federal law.

History

• Statutory Authority: §§ 37.2-100 and 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 37, Issue 2, eff. October 30, 2020.

12VAC35-105-440 Orientation of new employees, contractors, volunteers, and students

New employees, contractors, volunteers, and students shall be oriented commensurate with the individual's function or job-specific responsibilities within 15 business days. The provider shall document that the orientation covers each of the following policies, procedures, and practices:

1. Practices of confidentiality, including access, duplication, and dissemination of any portion of an individual's record;

2. Practices that ensure an individual's rights, including orientation to human rights regulations;

3. Emergency preparedness procedures;

4. Person-centeredness;

5. Infection control practices and measures;

6. Other policies and procedures that apply to specific positions and specific duties and responsibilities; and

7. Serious incident reporting, including when, how, and under what circumstances a serious incident report must be submitted and the consequences of failing to report a serious incident to the department in accordance with this chapter.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 36, Issue 22, eff. August 1, 2020; Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-450 Employee training and development

The provider shall provide training and development opportunities for employees to enable them to support the individuals receiving services and to carry out their job responsibilities. The provider shall develop a training policy that addresses the frequency of retraining on serious incident reporting, medication administration, behavior intervention, emergency preparedness, and infection control, to include flu epidemics. Employee participation in training and development opportunities shall be documented and accessible to the department.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 36, Issue 22, eff. August 1, 2020.

12VAC35-105-460 Emergency medical or first aid training

There shall be at least one employee or contractor on duty at each location who holds a current certificate (i) issued by the American Red Cross, the American Heart Association, or comparable authority in standard first aid and cardiopulmonary resuscitation (CPR) or (ii) as an emergency medical technician. A licensed medical professional who holds a current professional license shall be deemed to hold a current certificate in first aid, but not in CPR. The certification process shall include a hands-on, in-person demonstration of first aid and CPR competency.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 36, Issue 22, eff. August 1, 2020.

12VAC35-105-470 Notification of policy changes

The provider shall keep all employees and contractors informed of policy changes that affect the employee's or contractor's performance of duties.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-480 Employee or contractor performance evaluation

A. The provider shall implement a written policy for evaluating employee and contractor performance.

B. Employee development needs and plans shall be a part of the performance evaluation.

C. The provider shall evaluate employee and contractor performance at least annually.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-490 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; repealed, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-500 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 36, Issue 22, eff. August 1, 2020; repealed, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-510 Tuberculosis screening

A. Each new employee, contractor, student, or volunteer who will have direct contact with individuals receiving services shall obtain a statement of certification by a qualified licensed practitioner indicating the absence of tuberculosis in a communicable form within 30 days of employment or initial contact with individuals receiving services. The employee shall submit a copy of the original screening to the provider. A statement of certification shall not be required for a new employee who has separated from service with another licensed provider with a break in service of six months or less or who is currently working for another licensed provider.

B. All employees, contractors, students, or volunteers in substance abuse co-occurring outpatient or residential treatment services shall receive tuberculosis education on an annual basis. The education shall focus on self-presentation in the event of exposure to active tuberculosis or the development of symptoms of active tuberculosis.

C. Any employee, contractor, student, or volunteer who comes in contact with a known case of active tuberculosis disease or who develops symptoms of active tuberculosis disease, including fever, chills, hemoptysis, cough, fatigue, night sweats, weight loss, or anorexia, of three weeks duration shall be screened as determined appropriate for continued contact with employees, contractors, students, volunteers, or individuals receiving services based on consultation with the local health department.

D. No employee, contractor, student, or volunteer suspected of having active tuberculosis shall be permitted to return to work or have contact with employees, contractors, students, volunteers, or individuals receiving services until a physician has determined that the person is free of active tuberculosis.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 41, Issue 18, eff. June 19, 2025.

Article 5 Health and Safety Management

12VAC35-105-520 Risk management

A. The provider shall designate a person responsible for the risk management function who has completed department approved training, which shall include training related to risk management, understanding of individual risk screening, conducting investigations, root cause analysis, and the use of data to identify risk patterns and trends.

B. The provider shall implement a written plan to identify, monitor, reduce, and minimize harms and risk of harm, including personal injury, infectious disease, property damage or loss, and other sources of potential liability.

C. The provider shall conduct systemic risk assessment reviews at least annually to identify and respond to practices, situations, and policies that could result in the risk of harm to individuals receiving services. The risk assessment review shall address at least the following:

1. The environment of care;

2. Clinical assessment or reassessment processes;

3. Staff competence and adequacy of staffing;

4. Use of high risk procedures, including seclusion and restraint; and

5. A review of serious incidents.

D. The systemic risk assessment process shall incorporate uniform risk triggers and thresholds as defined by the department.

E. The provider shall conduct and document that a safety inspection has been performed at least annually of each service location owned, rented, or leased by the provider. Recommendations for safety improvement shall be documented and implemented by the provider.

F. The provider shall document serious injuries to employees, contractors, students, volunteers, and visitors that occur during the provision of a service or on the provider's property. Documentation shall be kept on file for three years. The provider shall evaluate serious injuries at least annually. Recommendations for improvement shall be documented and implemented by the provider.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 36, Issue 22, eff. August 1, 2020.

12VAC35-105-530 Emergency preparedness and response plan

A. The scope of emergency preparedness in relation to this section applies to disasters and emergencies as defined by § 44-146.16 of the Code of Virginia. The provider shall develop a written emergency preparedness and response plan for all services and locations that describes the provider's approach to emergencies throughout the organization or community. The plan shall address:

1. Specific procedures describing mitigation, preparedness, response, and recovery strategies, actions, and responsibilities for each emergency.

2. The process for notifying local and state authorities of the emergency and a process for contacting staff when emergency response measures are initiated.

3. Written emergency management policies outlining specific responsibilities for provision of administrative direction and management of response activities, coordination of logistics during the emergency, communications, life safety of employees, contractors, students, volunteers, visitors, and individuals receiving services, property protection, community outreach, and recovery and restoration.

4. Procedures for:

a. Warning, notifying, and communicating with individuals receiving services, employees, contractors, and community responders;

b. Providing emergency access to secure areas and opening locked doors;

c. Evacuating to emergency shelters or other alternative sites, relocating individuals receiving residential or inpatient services to new service locations, and accounting for all individuals receiving services;

d. Notifying family members or authorized representatives; and

e. Maintaining a 24-hour communications capability to respond to emergencies for individuals receiving services.

5. Processes for managing the following under emergency conditions:

a. Activities related to the provision of care, treatment, and services, including scheduling, modifying, or discontinuing services; protecting confidential information about individuals receiving services; providing medication; and coordinating transportation services; and

b. Logistics related to critical supplies, such as pharmaceuticals, food, linen, and water.

6. Schedules for testing the implementation of the plan and conducting emergency preparedness drills. Fire and evacuation drills shall be conducted at least monthly.

B. The provider shall evaluate each individual receiving services and, based on the individualized evaluations, shall provide appropriate environmental supports and adequate staff to safely evacuate all individuals during an emergency.

C. The provider shall implement annual emergency preparedness and response training for all employees, contractors, students, and volunteers that covers responsibilities for:

1. Alerting emergency personnel and sounding alarms;

2. Implementing evacuation procedures, including evacuation of individuals with special needs (i.e., deaf, blind, nonambulatory);

3. Using, maintaining, and operating emergency equipment;

4. Accessing emergency medical information for individuals receiving services; and

5. Utilizing community support services.

D. The provider shall review the emergency preparedness plan annually and make necessary revisions. Such revisions shall be communicated to employees, contractors, students, volunteers, and individuals receiving services and incorporated into orientation and training materials.

E. Providers of residential services shall have at all times a three-day supply of emergency food and water for all individuals receiving services and staff. Emergency food supplies should include foods that do not require cooking. Water supplies shall include one gallon of water per person per day.

F. All provider locations shall be equipped with at least one approved type-ABC portable fire extinguisher with a minimum rating of 2A10BC installed in each kitchen.

G. All provider locations shall have an appropriate number of properly installed smoke detectors based on the size of the location, which shall include, at a minimum:

1. At least one smoke detector on each level of multi-level buildings, including the basement;

2. At least one smoke detector in each bedroom in locations with bedrooms;

3. At least one smoke detector in any area adjacent to any bedroom in locations with bedrooms; and

4. Any additional smoke detectors necessary to comply with all applicable federal and state laws and regulations and local ordinances.

H. Smoke detectors shall be tested monthly for proper operation.

I. All provider locations shall maintain a floor plan identifying locations of:

1. Exits;

2. Primary and secondary evacuation routes;

3. Accessible egress routes;

4. Portable fire extinguishers; and

5. Flashlights.

J. This section does not apply to home-based or noncenter-based services.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 36, Issue 22, eff. August 1, 2020; Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-540 Access to telephone in emergencies; emergency telephone numbers

A. Telephones shall be accessible for emergency purposes.

B. Instructions for contacting emergency services and telephone numbers shall be prominently posted near the telephone including how to contact provider medical personnel if appropriate.

C. This section does not apply to home and noncenter-based services and correctional facilities.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-550 First aid kit accessible

A. A well-stocked first aid kit shall be maintained and readily accessible for minor injuries and medical emergencies at each service location and to employees or contractors providing in-home services or traveling with individuals. The minimum requirements of a well-stocked first aid kit that shall be maintained include a thermometer, bandages, saline solution, band-aids, sterile gauze, tweezers, instant ice-pack, adhesive tape, first-aid cream, and antiseptic soap.

B. A cardiopulmonary resuscitation (CPR) face guard or mask shall be readily accessible.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-560 Operable flashlights or battery lanterns

Operable flashlights or battery lanterns shall be readily accessible to employees and contractors in services that operate between dusk and dawn to use in emergencies. This section does not apply to home and noncenter-based services.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

Article 1 Service Description and Staffing

12VAC35-105-570 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; repealed, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-580 Service description requirements

A. The provider shall develop and implement descriptions of services offered and shall make service descriptions available for public review.

B. The provider shall outline how each service offers a structured program of individualized interventions and care designed to meet the individual's physical and emotional needs; provide protection, guidance, and supervision; and meet the objectives of any required individualized services plan.

C. Elements of each service description required by subsection A of this section shall include:

1. Service goals;

2. A description of care, treatment, skills acquisition, or other supports provided;

3. Characteristics and needs of individuals to receive services;

4. Contract services, if any;

5. Eligibility requirements and admission, continued stay, and exclusion criteria;

6. Service termination and discharge or transition criteria; and

7. Type and role of employees or contractors.

D. The provider shall not implement services that are inconsistent with its most current service description.

E. The provider shall admit only those individuals whose service needs are consistent with the service description, for whom services are available, and for whom staffing levels and types meet the needs of the individual receiving services.

F. The provider shall provide for the physical separation of children and adults in residential and inpatient services and shall provide separate group programming for adults and children, except in the case of family services. The provider shall provide for the safety of children accompanying parents receiving services.

G. The service description for substance abuse treatment services shall address the timely and appropriate treatment of pregnant women with substance abuse (substance use disorders).

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 36, Issue 22, eff. August 1, 2020; Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-590 Provider staffing plan

A. The provider shall implement a written staffing plan that includes the types, roles, and numbers of employees and contractors that are required to provide the service. This staffing plan shall reflect the:

1. Needs of the individuals receiving services;

2. Types of services offered;

3. Service description;

4. Number of individuals to receive services at a given time; and

5. Adequate number of staff required to safely evacuate all individuals during an emergency.

B. The provider staffing plan shall not include volunteers or students and shall not rely on students or volunteers to supplant direct care positions.

C. The provider shall develop a written transition staffing plan for new services, added locations, and changes in capacity.

D. The provider shall meet the following staffing requirements related to supervision.

1. The provider shall describe how employees and contractors will be supervised in the staffing plan and how that supervision will be documented.

2. Supervision of employees and contractors shall be provided by persons who have experience in working with individuals receiving services and in providing the services outlined in the service description.

3. Supervision shall be appropriate to the services provided and the needs of the individual. Supervision shall be documented.

4. Supervision shall include responsibility for approving assessments and individualized services plans, as appropriate. This responsibility may be delegated to an employee or contractor who meets the qualification for supervision as defined in this section.

5. Supervision of mental health, substance abuse, or co-occurring services that are of an acute or clinical nature, such as outpatient, inpatient, intensive in-home, or day treatment, shall be provided by a licensed mental health professional or a mental health professional who is license-eligible and registered with a board of the Department of Health Professions.

6. Supervision of collaborative behavioral health, substance abuse, or co-occurring services that are of a supportive or maintenance nature, such as psychosocial rehabilitation or mental health supports, shall be provided by (i) a registered QMHP who has practiced for three years and completed the supervisor training required by the Department of Health Professions; (ii) a licensed mental health professional who has completed the supervisor training required by the Department of Health Professions; or (iii) a person under supervision who is license-eligible, registered with the Board of Counseling, Board of Psychology, or Board of Social Work, and has completed the supervisor training required by the Department of Health Professions. A registered QMHP who meets these requirements may supervise activities within the QMHP's scope. This supervision must occur under the broader required direction of and in collaboration with the LMHP or licensed eligible mental health professional.

7. Supervision of developmental services shall be provided by a person with at least one year of documented experience working directly with individuals who have developmental disabilities and who holds at least a bachelor's degree in a human services field, such as sociology, social work, special education, rehabilitation counseling, nursing, or psychology. Experience may be substituted for the education requirement.

8. Supervision of brain injury services shall be provided, at a minimum, by a clinician in the health professions field who is trained and experienced in providing brain injury services to individuals who have a brain injury diagnosis, including (i) a doctor of medicine or osteopathy licensed in Virginia; (ii) a psychiatrist who is a doctor of medicine or osteopathy specializing in psychiatry and licensed in Virginia; (iii) a psychologist who has a master's degree in psychology from a college or university with at least one year of clinical experience; (iv) a social worker who has a bachelor's degree in human services or a related field (e.g., social work, psychology, psychiatric evaluation, sociology, counseling, vocational rehabilitation, human services counseling, or other degree deemed equivalent to those described) from an accredited college or university with at least two years of clinical experience providing direct services to individuals with a diagnosis of brain injury; (v) a Certified Brain Injury Specialist; (vi) a registered nurse licensed in Virginia with at least one year of clinical experience; or (vii) any other licensed rehabilitation professional with one year of clinical experience.

E. The provider shall employ or contract with persons with appropriate training, as necessary, to meet the specialized needs of and to ensure the safety of individuals receiving services in residential services with medical or nursing needs; speech, language, or hearing problems; or other needs where specialized training is necessary.

F. Providers of brain injury services shall employ or contract with a neuropsychologist or licensed clinical psychologist specializing in brain injury to assist, as appropriate, with initial assessments, development of individualized services plans, crises, staff training, and service design.

G. Staff in direct care positions providing brain injury services shall have at least a high school diploma and two years of experience working with individuals with disabilities or shall have successfully completed an approved training curriculum on brain injuries within six months of employment.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 19, Issue 24, eff. September 18, 2003; Volume 23, Issue 10, eff. February 21, 2007; Volume 28, Issue 5, eff. December 7, 2011; Volume 35, Issue 19, eff. June 15, 2019; Volume 36, Issue 22, eff. August 1, 2020; Volume 40, Issue 22, eff. July 17, 2024; Volume 41, Issue 20, eff. June 18, 2025; Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-600 Nutrition

A. A provider preparing and serving food shall:

1. Implement a written plan for the provision of food services, which ensures access to nourishing, well-balanced, varied, and healthy meals;

2. Make reasonable efforts to prepare meals that consider the cultural background, personal preferences, and food habits and that meet the dietary needs of the individuals served; and

3. Assist individuals who require assistance feeding themselves in a manner that effectively addresses any deficits.

B. Providers of residential and inpatient services shall implement a policy to monitor each individual's food consumption and nutrition for:

1. Warning signs of changes in physical or mental status related to nutrition; and

2. Compliance with any needs determined by the individualized services plan or prescribed by a physician, nutritionist, or health care professional.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-610 Community participation

Individuals receiving residential and day support services shall be afforded opportunities to participate in community activities that are based on their personal interests or preferences. The provider shall have written documentation that such opportunities were made available to individuals served.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-620 Monitoring and evaluating service quality

A. The provider shall develop and implement written policies and procedures for a quality improvement program sufficient to identify, monitor, and evaluate clinical and service quality and effectiveness on a systematic and ongoing basis.

B. The quality improvement program shall utilize standard quality improvement tools, including root cause analysis, and shall include a quality improvement plan.

C. The quality improvement plan shall:

1. Be reviewed and updated at least annually;

2. Define measurable goals and objectives;

3. Include and report on statewide performance measures, if applicable, as required by DBHDS;

4. Monitor implementation and effectiveness of approved corrective action plans pursuant to 12VAC35-105-170; and

5. Include ongoing monitoring and evaluation of progress toward meeting established goals and objectives.

D. The provider's policies and procedures shall include the criteria the provider will use to

1. Establish measurable goals and objectives ;

2. Update the provider's quality improvement plan; and

3. Submit revised corrective action plans to the department for approval or continue implementing the corrective action plan and put into place additional measures to prevent the recurrence of the cited violation and address identified systemic deficiencies when reviews determine that a corrective action was fully implemented but did not prevent the recurrence of the cited regulatory violation or correct a systemic deficiency pursuant to 12VAC35-105-170.

E. Input from individuals receiving services and their authorized representatives, if applicable, about services used and satisfaction level of participation in the direction of service planning shall be part of the provider's quality improvement plan. The provider shall implement improvements, when indicated.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 36, Issue 22, eff. August 1, 2020.

Article 2 Screening, Admission, Assessment, Service Planning, and Orientation

12VAC35-105-630 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; repealed, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-640 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; repealed, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-645 Initial contacts, screening, and admission

A. The provider shall implement policies and procedures for initial contacts and screening, admissions, and referral of individuals to other services and designate staff to perform these activities.

B. The provider shall maintain written documentation of each individual's initial contact and screening, including the:

1. Date of contact;

2. Name, age, and gender of the individual;

3. Address and telephone number of the individual, if applicable;

4. Reason why the individual is requesting services; and

5. Disposition of the individual, including referral to other services for further assessment, placement on a waiting list for service, or admission to the service.

C. Providers of crisis or case management services shall assist individuals who are not admitted to identify other appropriate services.

D. For individuals who are not admitted, the provider shall retain documentation of the individual's initial contact and screening referenced in subsection B of this section for a period of six months.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011; amended, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-650 Assessment policy

A. The provider shall implement a written assessment policy. The policy shall define how assessments will be conducted and documented.

B. The provider shall actively involve the individual and the individual's authorized representative, if applicable, in the preparation of initial and comprehensive assessments and in subsequent reassessments. In these assessments and reassessments, the provider shall consider the individual's needs, strengths, goals, preferences, and abilities within the individual's cultural context.

C. The assessment policy shall designate employees or contractors who are responsible for conducting assessments. These employees or contractors shall have experience in working with the needs of individuals who are being assessed, the assessment tools being utilized, and the provision of services that the individuals may require.

D. Assessment is an ongoing activity. The provider shall make reasonable attempts to obtain previous assessments or relevant history.

E. An assessment shall be initiated prior to or at admission to the service. With the participation of the individual and the individual's authorized representative, if applicable, the provider shall complete an initial assessment detailed enough to determine whether the individual qualifies for admission and to initiate an ISP for those individuals who are admitted to the service. This assessment shall assess immediate service, health, and safety needs, and, at a minimum, include the individual's:

1. Diagnosis;

2. Presenting needs, including the individual's stated needs, psychiatric needs, support needs, and the onset and duration of problems;

3. Current medical problems;

4. Current medications;

5. Current and past substance use or abuse, including co-occurring mental health and substance abuse disorders; and

6. At-risk behavior to self and others.

F. A comprehensive assessment shall update and finalize the initial assessment. The timing for completion of the comprehensive assessment shall be based upon the nature and scope of the service but shall occur no later than 30 days after admission for providers of mental health and substance abuse services and 60 days after admission for providers of developmental services. The comprehensive assessment shall address:

1. Onset and duration of problems;

2. Social, behavioral, developmental, and family history and supports;

3. Cognitive functioning, including strengths and weaknesses;

4. Employment, vocational, and educational background;

5. Previous interventions and outcomes;

6. Financial resources and benefits;

7. Health history and current medical care needs, to include:

a. Allergies;

b. Recent physical complaints and medical conditions;

c. Nutritional needs;

d. Chronic conditions;

e. Communicable diseases;

f. Restrictions on physical activities, if any;

g. Restrictive protocols or special supervision requirements;

h. Past serious illnesses, serious injuries, and hospitalizations;

i. Serious illnesses and chronic conditions of the individual's parents, siblings, and significant others in the same household; and

j. Current and past substance use, including alcohol, prescription and nonprescription medications, and illicit drugs.

8. Psychiatric and substance use issues, including current mental health or substance use needs, presence of co-occurring disorders, history of substance use or abuse, and circumstances that increase the individual's risk for mental health or substance use issues;

9. History of abuse, neglect, sexual or domestic violence, or trauma, including psychological trauma;

10. Legal status, including authorized representative, commitment, and representative payee status;

11. Relevant criminal charges or convictions and probation or parole status;

12. Daily living skills;

13. Housing arrangements;

14. Ability to access services, including transportation needs; and

15. As applicable, and in all residential services, fall risk, communication methods or needs, and mobility and adaptive equipment needs.

G. Providers of short-term intensive services, including inpatient and crisis stabilization services, shall develop policies for completing comprehensive assessments within the time frames appropriate for those services.

H. Providers of nonintensive or short-term services shall meet the requirements for the initial assessment at a minimum. Nonintensive services are services provided in jails, nursing homes, or other locations when access to records and information is limited by the location and nature of the services. Short-term services typically are provided for less than 60 days.

I. Providers may utilize standardized state or federally sanctioned assessment tools that do not meet all the criteria of this section as the initial or comprehensive assessment tools as long as the tools assess the individual's health and safety issues and substantially meet the requirements of this section.

J. Individuals who receive medication-only services shall be reassessed at least annually to determine whether there is a change in the need for additional services and the effectiveness of the medication.

K. This section does not apply to crisis services as crisis services shall comply with Part VIII of this chapter.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 36, Issue 22, eff. August 1, 2020; Volume 40, Issue 22, eff. July 17, 2024.

12VAC35-105-660 Individualized services plan (ISP)

A. The provider shall actively involve the individual and the individual's authorized representative, as appropriate, in the development, review, and revision of a person-centered ISP. The individualized services planning process shall be consistent with laws protecting confidentiality, privacy, human rights of individuals receiving services, and rights of minors.

B. The provider shall develop and implement an initial person-centered ISP for the first 60 days for developmental services or for the first 30 days for mental health and substance abuse services. This ISP shall be developed and implemented within 24 hours of admission to address immediate service, health, and safety needs and shall continue in effect until the ISP is developed or the individual is discharged, whichever comes first.

C. The provider shall implement a person-centered comprehensive ISP as soon as possible after admission based upon the nature and scope of services but no later than 30 days after admission for providers of mental health and substance abuse services and 60 days after admission for providers of developmental services.

D. The initial ISP and the comprehensive ISP shall be developed based on the respective assessment with the participation and informed choice of the individual receiving services.

1. To ensure the individual's participation and informed choice, the following shall be explained to the individual or the individual's authorized representative, as applicable, in a reasonable and comprehensible manner:

a. The proposed services to be delivered;

b. Any alternative services that might be advantageous for the individual; and

c. Any accompanying risks or benefits of the proposed and alternative services.

2. If no alternative services are available to the individual, it shall be clearly documented within the ISP, or within documentation attached to the ISP, that alternative services were not available as well as any steps taken to identify if alternative services were available.

3. Whenever there is a change to an individual's ISP, it shall be clearly documented within the ISP, or within documentation attached to the ISP that:

a. The individual participated in the development of or revision to the ISP;

b. The proposed and alternative services and their respective risks and benefits were explained to the individual or the individual's authorized representative; and

c. The reasons the individual or the individual's authorized representative chose the option included in the ISP.

E. This section does not apply to crisis services as crisis services shall comply with Part VIII of this chapter.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 19, Issue 24, eff. September 18, 2003; Volume 23, Issue 10, eff. February 21, 2007; Volume 28, Issue 5, eff. December 7, 2011; Volume 36, Issue 22, eff. August 1, 2020; Volume 40, Issue 22, eff. July 17, 2024.

12VAC35-105-665 ISP requirements

A. The comprehensive ISP shall be based on the individual's needs, strengths, abilities, personal preferences, goals, and natural supports identified in the assessment. The ISP shall include:

1. Relevant and attainable goals, measurable objectives, and specific strategies for addressing each need;

2. Services and supports and frequency of services required to accomplish the goals, including relevant psychological, mental health, substance abuse, behavioral, medical, rehabilitation, training, and nursing needs and supports;

3. The role of the individual and others in implementing the service plan;

4. A communication plan for individuals with communication barriers, including language barriers;

5. A behavioral support or treatment plan, if applicable;

6. A safety plan that addresses identified risks to the individual or to others, including a fall risk plan;

7. A crisis or relapse plan, if applicable;

8. Target dates for accomplishment of goals and objectives;

9. Identification of employees or contractors responsible for coordination and integration of services, including employees of other agencies;

10. Recovery plans, if applicable; and

11. Services the individual elects to self-direct, if applicable.

B. The ISP shall be signed and dated, at a minimum, by the person responsible for implementing the plan and the individual receiving services or the individual's authorized representative in order to document agreement. If the signature of the individual receiving services or the individual's authorized representative cannot be obtained, the provider shall document attempts to obtain the necessary signature and the reason why he was unable to obtain it. The ISP shall be distributed to the individual and others authorized to receive it.

C. The provider shall designate a person who shall be responsible for developing, implementing, reviewing, and revising each individual's ISP in collaboration with the individual or individual's authorized representative, as appropriate.

D. Employees or contractors who are responsible for implementing the ISP shall demonstrate a working knowledge of the objectives and strategies contained in the individual's current ISP, including an individual's detailed health and safety protocols.

E. Providers of short-term intensive services such as inpatient and crisis services that are typically provided for less than 30 days shall implement a policy to develop an ISP within a timeframe consistent with the length of stay of individuals.

F. When a provider provides more than one service to an individual, the provider may maintain a single ISP document that contains individualized objectives and strategies for each service provided.

G. Whenever possible, the identified goals in the ISP shall be written in the words of the individual receiving services.

H. This section does not apply to crisis services as crisis services shall comply with Part VIII of this chapter.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011; amended, Virginia Register Volume 36, Issue 22, eff. August 1, 2020; Volume 40, Issue 22, eff. July 17, 2024.

12VAC35-105-670 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; repealed, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-675 Reassessments and ISP reviews

A. Reassessments shall be completed at least annually and any time there is a need based on changes in the medical, psychiatric, behavioral, or other status of the individual.

B. Providers shall complete changes to the ISP as a result of the assessments.

C. The provider shall update the ISP at least annually and any time assessments identify risks, injuries, needs, or a change in status of the individual.

D. The provider shall complete quarterly reviews of the ISP at least every three months from the date of the implementation of the comprehensive ISP.

1. These reviews shall evaluate the individual's progress toward meeting the ISP's goals and objectives and the continued relevance of the ISP's objectives and strategies. The provider shall update the goals, objectives, and strategies contained in the ISP, if indicated, and implement any updates made.

2. These reviews shall document evidence of progression toward or achievement of a specific targeted outcome for each goal and objective.

3. For goals and objectives that were not accomplished by the identified target date, the provider and any appropriate treatment team members shall meet to review the reasons for lack of progress and provide the individual an opportunity to make an informed choice of how to proceed. Documentation of the quarterly review shall be added to the individual's record no later than 15 calendar days from the date the review was due to be completed, with the exception of case management services. Case management quarterly reviews shall be added to the individual's record no later than 30 calendar days from the date the review was due.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011; amended, Virginia Register Volume 35, Issue 12, eff. March 21, 2019; amended, Volume 36, Issue 22, eff. August 1, 2020; Volume 37, Issue 12, eff. March 4, 2021.

12VAC35-105-680 Progress notes or other documentation

The provider shall use signed and dated progress notes or other documentation to document the services provided and the implementation of the goals and objectives contained in the ISP.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-690 Orientation of individuals and authorized representatives

A. The provider shall implement a written policy regarding the orientation to services for individuals and authorized representatives, if applicable.

B. As appropriate to the scope and level of services, the policy shall require the provision to individuals and authorized representatives, if applicable, the following information:

1. Confidentiality practices and protections for individuals receiving services;

2. Human rights policies and protections and instructions on how to report violations;

3. Opportunities for participation in services and discharge planning;

4. Fire safety and emergency preparedness procedures, if applicable;

5. The provider's complaint procedure;

6. Service guidelines, including criteria for admission and discharge or transfer;

7. Hours and days of operation;

8. Availability of after-hours service; and

9. Any charges or fees due from the individual.

C. In addition to the provisions of subsection B of this section, orientation for individuals receiving treatment services in a correctional facility shall cover the facility's security restrictions.

D. The provider shall document that the individual and authorized representative, if applicable, received an orientation to services.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-691 Transition of individuals among services by the same provider

A. Except when transfer is ordered by a court of competent jurisdiction, the receiving service shall obtain from the sending service at the time of transfer:

1. Documentation of:

a. Informed choice by the individual or authorized representative, as applicable, in the decision to and planning for the transfer;

b. Notification to the family, if appropriate; and

c. Signature of the employee or contractor responsible for preparing the transfer summary and transfer date;

2. A written summary of the individual's progress while at the facility, justification for the transfer, and the individual's current strengths and needs; and

3. The individual's record, including emergency medical information.

B. The sending service shall retain a copy of the face sheet and a written summary of the individual's progress while within the service and shall document the date of transfer and the name of the service to which the individual was transferred.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011; amended, Virginia Register Volume 36, Issue 22, eff. August 1, 2020; Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-693 Discharge

A. The provider shall have written policies and procedures regarding the discharge or termination of individuals from the service. These policies and procedures shall include medical and clinical criteria for discharge.

B. Discharge instructions shall be provided in writing to the individual, the individual's authorized representative, and the successor provider, as applicable. At a minimum, discharge instructions shall include medications and dosages, if applicable; names, telephone numbers, and addresses of any successor providers to whom the individual is referred; current medical issues or conditions; and the identity of the individual's treating health care practitioners.

C. The provider shall make appropriate arrangements or referrals to all services or successor providers identified in the discharge plan prior to the individual's scheduled discharge date.

D. The content of the discharge plan and the determination to discharge the individual shall be consistent with the ISP and the criteria for discharge.

E. The provider shall complete a written discharge summary within 30 days of discharge that includes, at a minimum, the following:

1. Reason for the individual's admission to and discharge from the service;

2. Description of participation by the individual or the individual's authorized representative in discharge planning;

3. The individual's current level of functioning or functioning limitations, if applicable;

4. Recommended procedures, activities, or referrals to assist the individual in maintaining or improving functioning and increased independence;

5. The status, location, and arrangements that were made for future services;

6. Progress made by the individual in achieving goals and objectives identified in the ISP and a summary of critical events during service provision;

7. Date of discharge and when the discharge summary was actually written or documented; and

8. Signature of the provider's employee or contractor responsible for preparing the discharge summary.

F. This section does not apply to crisis services as crisis services shall comply with Part VIII of this chapter.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011; amended, Virginia Register Volume 40, Issue 22, eff. July 17, 2024; Volume 41, Issue 18, eff. June 19, 2025.

Article 3 Crisis Intervention and Emergencies

12VAC35-105-700 Written policies and procedures for crisis or emergency interventions; required elements

A. The provider shall implement written policies and procedures for prompt intervention in the event of a crisis, as defined in 12VAC35-105-20, or a behavioral, medical, or psychiatric emergency that may occur during screening and referral, at admission, or during the period of service provision.

B. The policies and procedures shall include:

1. A service-specific working definition of what constitutes a behavioral, medical, or psychiatric emergency;

2. Employee or contractor responsibilities; and

3. Location of emergency medical information for each individual receiving services, including any advance psychiatric or medical directive or crisis response plan developed by the individual, which shall be readily accessible to employees or contractors on duty in an emergency or crisis.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-710 Documenting crisis intervention and emergency services

A. The provider shall develop a method for documenting the provision of crisis intervention and emergency services. Documentation shall include the following:

1. Date and time;

2. Description of the nature of or circumstances surrounding the crisis or emergency;

3. Name of individual;

4. Description of precipitating factors;

5. Interventions or treatment provided;

6. Names of employees or contractors responding to or consulted during the crisis or emergency; and

7. Outcome.

B. If a crisis or emergency involves an individual who is admitted into service, documentation of the crisis intervention or provision of emergency services shall become part of his record.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

Article 4 Medical Management

12VAC35-105-720 Health care policy

A. The provider shall implement a policy, appropriate to the scope and level of service offered, that addresses provision of adequate and appropriate medical care. This policy shall describe how:

1. Medical care needs will be assessed, including circumstances that will prompt the decision to obtain a medical assessment.

2. Individualized services plans will address any medical care needs appropriate to the scope and level of service.

3. Identified medical care needs will be addressed.

4. The provider will manage medical care needs or respond to abnormal findings.

5. The provider will communicate medical assessments and diagnostic laboratory results to the individual and authorized representative, as appropriate.

6. The provider will keep accessible to staff and contractors on duty the names, addresses, and telephone numbers of the individual's medical and dental providers.

7. The provider will ensure a means for facilitating and arranging, as appropriate, transportation to medical and dental appointments and medical tests when services cannot be provided on site.

B. The provider shall implement written policies to identify any individuals who are at risk for falls and develop and implement a fall prevention and management plan and program for each at risk individual.

C. The provider shall implement written infection control measures, including the use of universal precautions.

D. The provider shall report outbreaks of infectious diseases to the Virginia Department of Health pursuant to § 32.1-37 of the Code of Virginia.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-730 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, September 19, 2002; repealed, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-740 Physical examination for residential and inpatient services

A. Within 30 days of an individual's admission, providers of residential or inpatient services shall either administer a physical examination or obtain results of an examination conducted within the previous 12 months. Providers of inpatient services shall administer physical exams within 24 hours of an individual's admission.

B. A physical examination shall include the date of examination and signature of a qualified practitioner.

C. The provider shall review and follow up with the results of the physical examination and of any follow-up diagnostic tests, treatments, or examinations in the individual's record.

D. This section does not apply to crisis services as crisis services shall comply with Part VIII of this chapter.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 40, Issue 22, eff. July 17, 2024; Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-750 Emergency medical information

A. The provider shall maintain the following emergency medical information for each individual:

1. If available, the name, address, and telephone number of:

a. The individual's physician; and

b. The authorized representative or other person to be notified;

2. Medical insurance company name and policy or Medicaid, Medicare , or CHAMPUS number, if any;

3. Currently prescribed medications and over-the-counter medications used by the individual;

4. Medication and food allergies;

5. History of substance abuse;

6. Significant medical problems or conditions;

7. Significant ambulatory or sensory problems;

8. Significant communication problems; and

9. Advance directive, if one exists.

B. Current emergency medical information shall be readily available to employees or contractors wherever program services are provided.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-760 Medical equipment

The provider shall develop and implement a policy on maintenance and use of medical equipment, including personal medical equipment and devices.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002.

Article 5 Medication Management Services

12VAC35-105-770 Medication management

A. The provider shall implement written policies addressing:

1. The safe administration, handling, storage, and disposal of medications;

2. The use of medication orders;

3. The handling of packaged medications brought by individuals from outside the facility;

4. Training requirements necessary for employees or contractors who are authorized to administer medication; and

5. The window within which medications can be given in relation to the ordered or established time of administration.

B. Medications shall be administered only by persons authorized to do so by the Drug Control Act (§ 54.1-3400 et seq. of the Code of Virginia).

C. Medications shall be administered as prescribed and only to the individuals for whom the medications are prescribed.

D. The provider shall maintain a daily log of all medicines received and refused by each individual. This log shall identify the employee or contractor who administered the medication, the name of the medication and dosage administered or refused, and the time the medication was administered or refused.

E. If the provider administers medications or supervises self-administration of medication in a service, a current medication order for all medications the individual receives shall be maintained on site.

F. The provider shall promptly dispose of discontinued drugs, outdated drugs, and drug containers with worn, illegible, or missing labels according to the applicable regulations of the Virginia Board of Pharmacy.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-780 Medication errors and drug reactions

In the event of a medication error or adverse drug reaction:

1. First aid shall be administered if indicated.

2. Employees or contractors shall promptly contact a poison control center, pharmacist, nurse or physician and shall take actions as directed.

3. The individual's physician shall be notified as soon as possible unless the situation is addressed in standing orders.

4. Actions taken by employees or contractors shall be documented.

5. The provider shall review medication errors at least quarterly as part of the quality assurance in 12VAC35-105-620.

6. Medication errors and adverse drug reactions shall be recorded in the individual's medication log.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002.

12VAC35-105-790 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; repealed, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

Article 6 Behavior Interventions

12VAC35-105-800 Policies and procedures on behavior interventions and supports

A. The provider shall implement written policies and procedures that describe conditions for the use of behavior interventions that comply with the requirements of 12VAC35-115, including seclusion, restraint, and time out. The policies and procedures shall:

1. List and define behavior interventions in the order of relative degree of intrusiveness or restrictiveness and the conditions under which each intervention may be used in accordance with each individual's ISP;

2. Protect the safety and well-being of the individual at all times, including during fire and other emergencies; and

3. Specify the mechanism for monitoring and documenting the use of behavior interventions.

B. Employees and contractors trained in behavior support interventions shall implement and monitor all behavior interventions.

C. Policies and procedures related to behavior interventions shall be available to individuals, families, authorized representatives, and advocates. Notification of policies does not need to occur in correctional facilities.

D. No individual receiving services shall discipline, restrain, seclude, or implement behavior interventions on other individuals receiving services.

E. Injuries resulting from or occurring during the implementation of seclusion or restraint shall be reported to the department as provided in 12VAC35-115-230 C.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 19, Issue 24, eff. September 18, 2003; Volume 28, Issue 5, eff. December 7, 2011; Volume 36, Issue 22, eff. August 1, 2020; Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-810 Behavioral treatment plan

A written behavioral treatment plan may be developed as part of the individualized services plan in response to behavioral needs identified through the assessment process. A behavioral treatment plan may include restrictions only if the plan has been developed according to procedures outlined in the human rights regulations. A behavioral treatment plan shall be developed, implemented, and monitored by employees or contractors trained in behavioral treatment.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-820 Prohibited actions

The following actions shall be prohibited:

1. Prohibition of contacts and visits with the individual's attorney, probation officer, placing agency representative, minister or chaplain;

2. Any action that is humiliating, degrading, or abusive;

3. Subjection to unsanitary living conditions;

4. Deprivation of opportunities for bathing or access to toilet facilities except as ordered by a licensed physician for a legitimate medical purpose and documented in the individual's record;

5. Deprivation of appropriate services and treatment;

6. Deprivation of health care;

7. Administration of laxatives, enemas, or emetics except as ordered by a physician or other professional acting within the scope of his license for a legitimate medical purpose and documented in the individual's record;

8. Applications of aversive stimuli except as permitted pursuant to other applicable state regulations;

9. Limitation on contacts with regulators, advocates or staff attorneys employed by the department or the Virginia Office for Protection and Advocacy.

10. Deprivation of drinking water or food necessary to meet an individual's daily nutritional needs except as ordered by a licensed physician for a legitimate medical purpose and documented in the individual's record;

11. Prohibition on contacts or visits with family or an authorized representative except as permitted by other applicable state regulations or by order of a court of competent jurisdiction;

12. Delay or withholding of incoming or outgoing mail except as permitted by other applicable state and federal regulations or by order of a court of competent jurisdiction; and

13. Deprivation of opportunities for sleep or rest except as ordered by a licensed physician for a legitimate medical purpose and documented in the individual's record.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-830 Seclusion, restraint, and time out

A. The use of seclusion, restraint, and time out shall comply with applicable federal and state laws and regulations and be consistent with the provider's policies and procedures.

B. Devices used for mechanical restraint shall be designed specifically for emergency behavior management of human beings in clinical or therapeutic programs.

C. Application of time out, seclusion, or restraint shall be documented in the individual's record and include the following:

1. Physician's order for seclusion or mechanical restraint or chemical restraint;

2. Date and time;

3. Employees or contractors involved;

4. Circumstances and reasons for use including other emergency behavior management techniques attempted;

5. Duration;

6. Type of technique used; and

7. Outcomes, including documentation of debriefing of the individual and staff involved following the incident.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 36, Issue 22, eff. August 1, 2020.

12VAC35-105-840 Requirements for seclusion room

A. The room used for seclusion shall meet the design requirements for buildings used for detention or seclusion of individuals.

B. The seclusion room shall be at least six feet wide and six feet long with a minimum ceiling height of eight feet.

C. The seclusion room shall be free of all protrusions, sharp corners, hardware, fixtures or other devices which may cause injury to the individual.

D. Windows in the seclusion room shall be so constructed as to minimize breakage and otherwise prevent the individual from harming himself.

E. Light fixtures and other electrical receptacles in the seclusion room shall be recessed or so constructed as to prevent the individual from harming himself. Light controls shall be located outside the seclusion room.

F. Doors to the seclusion room shall be at least 32 inches wide, shall open outward and shall contain observation view panels of transparent wire glass or its approved equivalent, not exceeding 120 square inches but of sufficient size for someone outside the door to see into all corners of the room.

G. The seclusion room shall contain only a mattress with a washable mattress covering designed to avoid damage by tearing.

H. The seclusion room shall maintain temperatures appropriate for the season.

I. All space in the seclusion room shall be visible through the locked door, either directly or by mirrors.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-850 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; repealed, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-860 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; repealed, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-870 Records management policy

A. The provider shall develop and implement a written records management policy that describes confidentiality, accessibility, security, and retention of records pertaining to individuals, including:

1. Access, duplication, dissemination, and acquisition of individual information only to persons legally authorized according to federal and state laws;

2. Storage, processing, and handling of active and closed records;

3. Security measures to protect records from loss, unauthorized alteration, inadvertent or unauthorized access, disclosure of information, and transportation of records between service sites;

4. Strategies for service continuity and record recovery from interruptions that result from disasters or emergencies, including contingency plans, electronic or manual back-up systems, and data retrieval systems; and

5. Disposition of records in the event that the service ceases operation. If the disposition of records involves a transfer to another provider, the provider shall have a written agreement with that provider.

B. The records management policy shall be consistent with applicable state and federal laws and regulations related to privacy of health records, including:

1. Section 32.1-127.1:03 of the Code of Virginia;

2. 42 USC § 290dd;

3. 42 CFR Part 2; and

4. The Health Insurance Portability and Accountability Act (Public Law 104-191) and implementing regulations (45 CFR Parts 160, 162, and 164).

C. The policy shall specify what information is available to the individual.

D. Active and closed records shall be kept in areas that are accessible to authorized staff and protected from unauthorized access, fire, and flood.

E. Entries in the individual's record shall be current, dated, and authenticated by the person making the entry. Errors shall be corrected by striking through and initialing.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-880 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; repealed, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-890 Individual's service record

A. There shall be a separate primary record for each individual admitted for service. A separate record shall be maintained for each family member who is receiving individual treatment. The provider shall maintain each individual's record in accordance with § 32.1-127.1:03 of the Code of Virginia.

B. All individuals admitted to the service shall have identifying information readily accessible in the individual's service record. Identifying information shall include the following:

1. Identification number unique for the individual;

2. Name of individual;

3. Current residence, if known;

4. Social security number;

5. Gender;

6. Marital status;

7. Date of birth;

8. Name of authorized representative, if applicable;

9. Name, address, and telephone number for emergency contact;

10. Adjudicated legal incompetency or legal incapacity, if applicable; and

11. Date of admission to service.

C. In addition, an individual's service record shall contain, at a minimum:

1. Screening documentation;

2. Assessments;

3. Medical evaluation, as applicable to the service;

4. Individualized services plans and reviews;

5. Progress notes; and

6. A discharge summary, if applicable.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-900 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; repealed, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-910 Retention of individual's service records

The provider shall retain an individual's service record for the time period specified by state or federal requirements.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-920 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; repealed, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

Article 1 Medication Assisted Treatment (Opioid Treatment Services)

12VAC35-105-925 Standards for the evaluation of new licenses for providers of services to individuals with opioid addiction

A. Applicants requesting an initial license to provide a service for the treatment of opioid addiction through the use of methadone or any other opioid treatment medication or controlled substance shall supply information to the department that demonstrates the appropriateness of the proposed service in accordance with this section.

B. The proposed site of the service shall comply with § 37.2-406 of the Code of Virginia.

C. In jurisdictions without zoning ordinances, the department shall request that the local governing body advise it as to whether the proposed site is suitable for and compatible with use as an office and the delivery of health care services. The department shall make this request when it notifies the local governing body of a pending application.

D. Applicants shall demonstrate that the building or space to be used to provide the proposed service is suitable for the treatment of opioid addiction by submitting documentation of the following:

1. The proposed site complies with the requirements of the local building regulatory entity;

2. The proposed site complies with local zoning laws or ordinances, including any required business licenses;

3. In the absence of local zoning ordinances, the proposed site is suitable for and compatible with use as offices and the delivery of health care services;

4. In jurisdictions where there are no parking ordinances, the proposed site has sufficient off-street parking to accommodate the needs of the individuals being served and prevent the disruption of traffic flow;

5. The proposed site can accommodate individuals during periods of inclement weather;

6. The proposed site complies with the Virginia Statewide Fire Prevention Code; and

7. The applicant has a written plan to ensure security for storage of methadone at the site, which complies with regulations of the Drug Enforcement Agency (DEA) and the Virginia Board of Pharmacy.

E. Applicants shall submit information to demonstrate that there are sufficient personnel available to meet the following staffing requirements and qualifications:

1. The program sponsor means the person responsible for the operation of the opioid treatment program and who assumes responsibility for all its employees, including any practitioners, agents, or other persons providing medical, behavioral health, or social services at the program at any of its medication units. The program sponsor is responsible for ensuring the program is in continuous compliance with all federal, state, and local laws and regulations.

2. The program director or manager shall be licensed or certified by the applicable Virginia health regulatory board or registered as eligible for this license or certification with relevant training, experience, or both, in the treatment of individuals with opioid addiction. The program director is responsible for the day-to-day management of the program.

3. The medical director shall be a physician licensed to practice medicine in the Commonwealth with relevant training or experience in the treatment of individuals with opioid addiction and:

a. Is responsible for ensuring all medical and behavioral health services offered by the medication for opioid use disorder treatment provider are conducted in compliance with federal regulations at all times; and

b. Shall be physically present at the program for a sufficient number of hours to ensure regulatory compliance and carry out those duties specifically assigned to the medical director by regulation.

4. A minimum of one health care professional who is appropriately licensed by the Commonwealth to prescribe and dispense medications for opioid use disorders.

5. Nurses.

6. Counselors shall be licensed or certified by the applicable Virginia health regulatory board or eligible for this license or certification.

7. Personnel to provide support services.

8. Have linkage with or access to psychological, medical, and psychiatric consultation.

9. Have access to emergency medical and psychiatric care through affiliations with more intensive levels of care.

10. Have the ability to conduct or arrange for appropriate laboratory and toxicology tests.

11. Ensure all clinical staff, whether employed by the provider or available through consultation, contract, or other means, are qualified by training and experience and appropriately licensed, certified, or registered by the appropriate health regulatory board to serve individuals admitted to the service.

F. The applicant may provide peer recovery specialists (PRS). Peer recovery specialists shall be professionally qualified by education and experience in accordance with 12VAC35-250. A registered peer recovery specialist shall be a PRS registered with the Board of Counseling in accordance with 18VAC115-70 and provide such services as an employee or independent contractor of DBHDS, a provider licensed by DBHDS, a practitioner licensed by or holding a permit issued from the Department of Health Professions, or a facility licensed by the Virginia Department of Health.

G. If there is a change in or loss of any staff in the positions listed or any change in the provider's ability to comply with the requirements in subsection E of this section, the provider shall formally notify the Substance Abuse and Mental Health Services Administration (SAMHSA) and DBHDS. The provider shall also submit a plan to SAMHSA and DBHDS for immediate coverage within three weeks.

H. Applicants shall submit a description for the proposed service that includes:

1. Proposed mission, philosophy, and goals of the provider;

2. Care, treatment, and services to be provided, including a comprehensive discussion of levels of care provided and alternative treatment strategies offered;

3. Proposed hours and days of operation;

4. Plans for onsite security and services adequate to ensure the safety of patients, staff, and property; and

5. A diversion control plan for dispensed medications, including policies for use of drug screens.

I. Applicants shall, in addition to the requirements of 12VAC35-105-580 C 2, provide documentation of their capability to provide the following services and support directly or by arrangement with other specified providers when such services and supports are (i) requested by an individual being served or (ii) identified as an individual need, based on the assessment conducted in accordance with 12VAC35-105-60 B, and included in the individualized services plan:

1. General.

a. Psychological services;

b. Social services;

c. Vocational services;

d. Educational services, including HIV/AIDS education and other health education services; and

e. Employment services.

2. Initial medical examination services.

3. Special services for pregnant patients.

4. Initial and periodic, individualized, patient-centered assessment and treatment services.

5. Counseling services.

6. Drug abuse testing services.

7. Case management services, including medical monitoring and coordination, with onsite and offsite treatment services provided as needed.

J. Applicants shall submit documentation of contact with community services boards or behavioral health authorities in their service areas to discuss their plans for operating in the area and to develop joint agreements, as appropriate.

K. Applicants shall provide policies and procedures that shall address assessment, administration, and regulation of medication and dose levels appropriate to the individual. The policies and procedures shall at a minimum require that each individual served be assessed every six months by the treatment team to determine if that individual is appropriate for safe and voluntary medically supervised withdrawal from opioid analgesics, including methadone or buprenorphine, alternative therapies including other medication-assisted treatments, or continued federally approved pharmacotherapy treatment for opioid addiction.

L. Applicants shall submit policies and procedures describing services the applicant will provide to individuals who wish to discontinue medication for opioid use disorder treatment services.

M. Applicants shall provide assurances that the service will have a community liaison responsible for developing and maintaining cooperative relationships with community organizations, other service providers, local law enforcement, local government officials, and the community at large.

N. The department shall conduct announced and unannounced reviews and complaint investigations in collaboration with the Virginia Board of Pharmacy and DEA to determine compliance with the regulations.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 20, eff. July 11, 2007; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 33, Issue 26, eff. October 6, 2017; Volume 39, Issue 11, eff. February 17, 2023; Volume 42, Issue 3, eff. December 1, 2025.

12VAC35-105-930 Registration, certification, or accreditation

A. The medication for opioid use disorder treatment service shall maintain current registration or certification with:

1. The federal Drug Enforcement Administration;

2. The federal Department of Health and Human Services; and

3. The Virginia Board of Pharmacy.

B. A provider of medication for opioid use disorder treatment services shall maintain accreditation with an entity approved under federal regulations.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 39, Issue 11, eff. February 17, 2023; Volume 42, Issue 3, eff. December 1, 2025.

12VAC35-105-935 Criteria for patient admission

A. Before a medication for opioid use disorder treatment provider may admit an individual, the individual shall meet the criteria for admission as defined by the provider's policies. The provider's policy regarding admission shall at a minimum require the individual to (i) meet diagnostic criteria for opioid use disorder as defined within the DSM and (ii) meet the admission criteria of Level 1.0 of ASAM. The policies shall be consistent with subsections B through D of this section.

B. A medication for opioid use disorder treatment provider's qualified personnel shall assess individuals to determine if the individuals are appropriate for treatment by applying established diagnostic criteria documented in the provider's procedures.

C. A medication for opioid use disorder treatment provider shall maintain current procedures designed to ensure that individuals are admitted to maintenance treatment by qualified personnel who have determined, using accepted medical criteria, that the person currently has an addiction to an opioid drug. In addition, an opioid treatment practitioner shall ensure that each individual voluntarily chooses maintenance treatment, that all relevant facts concerning the use of the opioid drug are clearly and adequately explained to the individual, and that each individual provides informed written consent to treatment.

D. No individual younger than 18 years of age may be admitted to maintenance treatment without written consent from a parent, legal guardian, or responsible adult designated by the relevant state authority.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023; amended, Virginia Register Volume 42, Issue 3, eff. December 1, 2025.

12VAC35-105-940 Criteria for involuntary termination from treatment

A. The provider shall establish criteria for involuntary termination from treatment that describe the rights of the individual receiving services and the responsibilities and rights of the provider.

B. The provider shall establish a grievance procedure as part of the rights of the individual.

C. On admission, the individual shall be given a copy of the criteria and grievance procedure and shall sign a statement acknowledging receipt of same. The signed acknowledgment shall be maintained in the individual's service record.

D. Upon admission and annually thereafter all individuals shall sign an authorization for disclosure of information to allow the provider access to the Virginia Prescription Monitoring System. Individuals who fail to sign this authorization shall be denied admission to the program.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-945 Criteria for patient discharge

Before a medication for opioid use disorder treatment provider discharges or transfers, the individual shall meet the criteria for discharge or transfer as defined by the provider's policies, which shall include provisions for the discharge or transfer of individuals who have:

1. Achieved the goals of the treatment services and no longer require medication for opioid use disorder treatment level of care;

2. Been unable to achieve the goals of the individual's treatment but could achieve the individual's goals with a different type of treatment; or

3. Achieved the individual's original treatment goals but have developed new treatment challenges that can only be adequately addressed in a different type of treatment.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023; amended, Virginia Register Volume 42, Issue 3, eff. December 1, 2025.

12VAC35-105-950 Service operation schedule

A. The service's days of operation shall meet the needs of the individuals served. If the service dispenses or administers a medication requiring daily dosing, the service shall operate seven days a week, 12 months a year, except for official state holidays. Prior approval from the state methadone authority shall be required for additional closed days.

B. The service may close on Sundays if all the following criteria are met:

1. The provider develops and implements policies and procedures that address recently admitted individuals receiving services, individuals not currently on a stable dose of medication, patients that present noncompliance treatment behaviors, and individuals who previously picked up take-home medications on Sundays, security of take-home medication doses, and health and safety of individuals receiving services.

2. The provider receives prior approval from the state opioid treatment authority (SOTA) for Sunday closings. Each program must have a policy that addresses medication for the newly inducted patients and those who are deemed at risk, for example, are still actively using illicit substances or medical issues that may warrant closer monitoring of medication.

3. Once approved, by the SOTA to close on Sundays, the provider shall notify individuals receiving services in writing at least 30 days in advance of their intent to close on Sundays. The notice shall address the risks to the individuals and the security of take-home medications. All individuals shall receive an orientation addressing take-home policies and procedures, and this orientation shall be documented in the individual's service record prior to receiving take-home medications.

4. The provider shall establish procedures for emergency access to dosing information 24 hours a day, seven days a week. This information may be provided via an answering service, pager, or other electronic measures. Information needed includes the individual's last dosing time and date, and dose.

C. Medication dispensing hours shall include at least two hours each day of operation outside normal working hours, that is, before 9 a.m. and after 5 p.m. The SOTA may approve an alternative schedule if the SOTA determines that schedule meets the needs of the population served by the provider.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-960 Initial and periodic assessment services

A. The provider shall require each individual to undergo an initial medical examination. The initial medical examination is comprised of two parts:

1. A screening examination to ensure that the individual meets the criteria for admission in accordance with 12VAC35-105-935 and that there are no contraindications to treatment with MOUD; and

2. A full health history and examination, including a physical examination, to determine the individual's broader health status, with lab testing as determined by an appropriately licensed practitioner. An individual's refusal to undergo lab testing for co-occurring physical health conditions should not preclude access to treatment, provided such refusal does not have the potential to negatively impact treatment with medications. The individual's full health history and examination shall be completed within 14 days of admission.

B. Both the screening examination and the full health history and examination shall be completed by an appropriately licensed practitioner. When the initial medical examination is performed outside of the provider's service:

1. The written results, narrative of the initial medical examination, and available lab testing results must be transmitted, consistent with applicable privacy laws, to the provider and verified by an opioid treatment practitioner; and

2. If the original screening examination was not conducted by an opioid treatment practitioner, the screening shall occur not more than seven days prior to admission to the provider's service.

C. The provider shall maintain the report of the individual's initial medical examination in the individual's service record.

D. The provider shall have a policy to ensure that coordination of care is in place with any prescribing physician.

E. The provider shall coordinate treatment services for individuals who are prescribed benzodiazepines and prescription narcotics with the treating physician. The coordination shall be the responsibility of the provider's physician and shall be documented.

F. Serology testing and other testing as deemed medically appropriate by the provider's physician based on the screening and full health history and examination, drawn not more than 30 days prior to admission to the provider's service, may form part of the initial medical examination.

G. An evaluation of an individual for treatment shall occur in person or use audio-visual telemedicine platforms. When not available, a provider may use audio-only devices, but only when the individual is in the presence of a licensed practitioner who is registered to prescribe and dispense controlled medications. The licensed practitioner shall document being physically present during the audio-only evaluation through signature in the individual's record. The provider's physician shall review the initial medical examination results and order MOUD as indicated.

H. Qualified personnel shall review a consent-to-treatment form with the patient and shall document informed written consent prior to the individual receiving the first dose of MOUD.

I. Assuming no contraindications, an individual may begin MOUD treatment after the screening examination is completed.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 39, Issue 11, eff. February 17, 2023; Volume 42, Issue 3, eff. December 1, 2025.

12VAC35-105-965 Special services for pregnant individuals

The program shall ensure that every pregnant woman has the opportunity for prenatal care, prenatal education, and postpartum follow-up, either onsite or by referral to an appropriate health care provider.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-970 Counseling sessions

A. For the purposes of this section, "face-to-face" shall include telemedicine.

B. The provider shall conduct face-to-face counseling sessions (either individual or group) at a frequency tailored to each individual based on an individualized assessment and the individual's care plan that was created after shared decision-making between the individual and the clinical team. At a minimum, the provider shall conduct one in-person session once a month for the first year of the individual's treatment and quarterly during the second year. The failure of an individual to participate in counseling sessions shall be addressed as part of the overall treatment process.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 42, Issue 3, eff. December 1, 2025.

12VAC35-105-980 Drug screens

A. The provider shall perform at least eight random drug screens per year unless the conditions in subsection B of this section apply.

B. Whenever an individual's drug screen indicates continued illicit drug use or when clinically and environmentally indicated, random drug screens shall be performed at a frequency that is in accordance with generally accepted clinical practice and as indicated by the individual's response to stability in treatment.

C. Drug screens shall be analyzed for opiates, methadone (if ordered), benzodiazepines, cocaine, and buprenorphine. In addition, drug screens for other drugs that have the potential for addiction shall be performed when clinically and environmentally indicated.

D. The provider shall implement a written policy on how the results of drug screens shall be used to direct treatment.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 39, Issue 11, eff. February 17, 2023; Volume 42, Issue 3, eff. December 1, 2025.

12VAC35-105-990 Take-home medication

A. Determinations for take-home approval shall be based on the clinical judgment of the provider's physician in consultation with the treatment team and shall be documented in the individual's service record. Prior to dispensing regularly scheduled take-home medication, the medical director or opioid treatment practitioner shall ensure the individual demonstrates that the therapeutic benefits of unsupervised doses outweigh the risk as evidenced by the following criteria:

1. Absence of active substance use disorders, other physical or behavioral health conditions that increase the risk of harm as it relates to the potential for overdose, or the ability to function safely;

2. Regularity of attendance for supervised medication administration;

3. Absence of serious behavioral problems that endanger the individual, the public, or others;

4. Absence of known recent diversion activity;

5. Whether take-home medication can be safely transported and stored; and

6. Any other criteria that the medical director or opioid treatment practitioner considers relevant to the individual's safety and the public health.

B. Any individual in comprehensive maintenance treatment who is assessed to be appropriate to handle take-home medication shall undergo continued assessment and management to ensure suitability.

C. If it is determined that an individual in comprehensive maintenance treatment is appropriate for handling take-home medication, including take-home medication for provider closures, the amount of take-home medication shall not exceed:

1. A single take-home dose for one day when the clinic is closed for business, including Sundays and state or federal holidays, for the first seven days of treatment.

2. A maximum of a five-day consecutive supply of take-home doses from eight days of treatment to 30 days of treatment.

3. A maximum of a 14-day supply of take-home doses from 31 days of treatment to 60 days of treatment.

4. A maximum of a 28-day consecutive supply of take-home medication after 60 days of treatment.

D. Exceptions to the take-home schedule in subsection C of this section may be made if approved by the SOTA or designee.

E. No medication shall be dispensed to individuals in short-term withdrawal management treatment or interim maintenance treatment for unsupervised take-home use.

F. Medication for opioid use disorder treatment providers shall maintain current procedures adequate to identify the theft or diversion of take-home medications. These procedures shall require the labeling of containers with the medication for opioid use disorder treatment provider's name, address, and telephone number. Providers shall ensure that the take-home supplies are packaged in a manner that is designed to reduce the risk of accidental ingestion, including child proof containers.

G. The provider shall educate the individual on the safe transportation and storage of take-home medication.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 39, Issue 11, eff. February 17, 2023; Volume 42, Issue 3, eff. December 1, 2025.

12VAC35-105-1000 Preventing duplication of medication services

To prevent duplication of medication for opioid use disorder treatment services, the provider shall implement written policy and procedures for contacting every medication for opioid use disorder treatment service within a 50-mile radius before admitting an individual to the service.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 39, Issue 11, eff. February 17, 2023; Volume 42, Issue 3, eff. December 1, 2025.

12VAC35-105-1010 Guests

A. For the purposes of this section, a guest is a patient of a medication for opioid use disorder treatment service in another state or another area of Virginia, who is traveling and is not yet eligible for take-home medication. Guest dosing shall be approved by the individual's home clinic and the receiving clinic's physician or medical director.

B. The provider shall not dispense medication to any guest unless the guest has been receiving such medication services from another provider and documentation from that provider has been received prior to dispensing medication.

C. Guests may receive medication for up to 28 days. To continue receiving medication after 28 days, the guest must be admitted to the service. Individuals receiving guest medications as part of a residential treatment service may exceed the 28-day maximum time limit at the medication for opioid use disorder treatment service.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 39, Issue 11, eff. February 17, 2023; Volume 42, Issue 3, eff. December 1, 2025.

12VAC35-105-1020 Withdrawal management prior to involuntary discharge

A. The provider shall give an individual who is being involuntarily discharged an opportunity to withdraw from opioid agonist medication not less than 10 days or not more than 30 days prior to the individual's discharge from the service, unless the SOTA has granted an exception.

B. Providers may immediately discharge an individual who has exhibited violent behavior if the provider has defined within its policies the circumstances under which such discharge would be appropriate.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 42, Issue 3, eff. December 1, 2025.

12VAC35-105-1030 Opioid agonist medication renewal

Physician orders for opioid agonist medication shall be reevaluated and renewed at least every six months.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002.

12VAC35-105-1040 Emergency preparedness plan

The provider's emergency preparedness plan shall include provision for the continuation of opioid treatment in the event of an emergency or natural disaster.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-1050 Security of opioid agonist medication supplies

A. At a minimum, the provider shall secure opioid agonist medication supplies by restricting access to medication areas to medical or pharmacy personnel.

B. The provider shall reconcile the medication inventory monthly.

C. The provider shall keep inventory records, including the monthly reconciliation, for three years.

D. The provider shall maintain a current plan to control the diversion of medication to unprescribed or illegal uses.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

Article 2 Medically Managed Withdrawal Services [Repealed]

12VAC35-105-1055 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011; repealed, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-1060 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; repealed, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-1070 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; repealed, Virginia Register Volume 42, Issue 3, eff. December 1, 2025.

12VAC35-105-1080 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; repealed, Virginia Register Volume 41, Issue 18, eff. June 19, 2025.

12VAC35-105-1090 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; repealed, Virginia Register Volume 42, Issue 3, eff. December 1, 2025.

12VAC35-105-1100 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; repealed, Virginia Register Volume 42, Issue 3, eff. December 1, 2025.

12VAC35-105-1110 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 39, Issue 11, eff. February 17, 2023; repealed, Virginia Register Volume 42, Issue 3, eff. December 1, 2025.

12VAC35-105-1120 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 40, Issue 22, eff. July 17, 2024; repealed, Virginia Register Volume 42, Issue 3, eff. December 1, 2025.

12VAC35-105-1130 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; repealed, Virginia Register Volume 42, Issue 3, eff. December 1, 2025.

Article 3 Services in Department of Corrections Correctional Facilities

12VAC35-105-1140 Clinical and security coordination

A. The provider shall have formal and informal methods of resolving procedural and programmatic issues regarding individual care arising between the clinical and security employees or contractors.

B. The provider shall demonstrate ongoing communication between clinical and security employees to ensure individual care.

C. The provider shall provide cross-training for the clinical and security employees or contractors that includes:

1. Mental health, developmental disability, and substance abuse education;

2. Use of clinical and security restraints; and

3. Channels of communication.

D. Employees or contractors shall receive periodic in-service training, and have knowledge of and be able to demonstrate the appropriate use of clinical and security restraint.

E. Security and behavioral assessments shall be completed at the time of admission to determine service eligibility and at least weekly for the safety of individuals, other persons, employees, and visitors.

F. Personal grooming and care services for individuals shall be a cooperative effort between the clinical and security employees or contractors.

G. Clinical needs and security level shall be considered when arrangements are made regarding privacy for individual contact with family and attorneys.

H. Living quarters shall be assigned on the basis of the individual's security level and clinical needs.

I. An assessment of the individual's clinical condition and needs shall be made when disciplinary action or restrictions are required for infractions of security measures.

J. Clinical services consistent with the individual's condition and plan of treatment shall be provided when security detention or isolation is imposed.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 36, Issue 22, eff. August 1, 2020.

12VAC35-105-1150 Other requirements for correctional facilities

A. Group bathroom facilities shall be partitioned between toilets and urinals to provide privacy.

B. If uniform clothing is required, the clothing shall be properly fitted, climatically suitable, durable, and presentable.

C. Financial compensation for work performed shall be determined by the Department of Corrections. Personal housecleaning tasks may be assigned without compensation to the individual.

D. The use of audio equipment, such as televisions, radios, and record players, shall not interfere with therapeutic activities.

E. Aftercare planning for individuals nearing the end of incarceration shall include a provision for continuing medication and follow-up services with area community services to facilitate successful reintegration into the community including specific appointment provided to the inmate no later than the day of release.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

Article 4 Sponsored Residential Homes Services

12VAC35-105-1160 Sponsored residential home information

Providers of sponsored residential home services shall maintain the following information:

1. Names and ages of residential sponsors;

2. Date of sponsored residential home agreement;

3. The maximum number of individuals that can be placed in the home at a given time;

4. Names and ages of all other individuals who are not receiving services but are residing in a sponsored residential home;

5. Address and telephone number of the sponsored residential home; and

6. Names of all staff employed in the home, including on-call and substitute staff.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-1170 Sponsored residential home agreements

A. The provider shall maintain a written agreement with residential home sponsors. Sponsors are persons who provide the home where the service is located and are directly responsible for the provision of services. The agreement shall include the:

1. Provider's responsibilities;

2. Sponsor's responsibilities;

3. Scope of services;

4. Supervision;

5. Compensation;

6. Training; and

7. Reporting requirements and procedures.

B. The agreement shall be available for inspection by the licensing specialist and shall include a provision for granting the right of entry to state licensing specialists or human rights advocates to conduct inspections.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-1180 Sponsor qualification and approval process

A. The provider shall evaluate and certify each sponsored residential home other than his own through face-to-face interviews, home inspections, and other information documenting compliance with this section. The provider shall submit the certification form to the department before individuals are placed in the home and ensure that the following requirements are met annually.

B. The provider shall certify and document that each sponsored residential home meets the criteria for physical environment and residential services in these regulations.

C. The provider shall document the ability of the sponsored residential home staff to meet the needs of the individuals placed in the home by assessing and documenting:

1. The ability of the sponsor or any staff to communicate and understand individuals receiving services;

2. The ability of the sponsor or any staff to provide the care, treatment, training, or habilitation for individuals receiving services in the home;

3. The abilities of all members of the sponsored household to accept individuals with disabilities and their disability-related characteristics, especially the ability of children in the household to adjust to nonfamily members living with them;

4. The financial capacity of the sponsor to meet the sponsor's own expenses for up to 90 days, independent of payments received for residents living in the home; and

5. The education, qualifications, and experience of the sponsor or staff with the individuals served including Virginia Department of Motor Vehicles driving record, tuberculosis screening, first-aid and CPR certification, and completion of medication administration and behavior interventions training.

D. The provider shall obtain three job-related references, past licensing history, criminal background checks, and a search of the registry of founded complaints of child abuse and neglect maintained by the Department of Social Services for the sponsor and all staff.

E. The provider shall implement written policies for obtaining references, criminal background checks, and registry checks for all adults in the home who are neither staff nor individuals being served. The policy shall indicate what action the provider will take if the results indicate that a member of the sponsor family has been convicted of a barrier crime or fails to meet the requirements of this regulation should an ineligible result be received.

F. The sponsored residential home shall submit to the provider the results of a physical and mental health examination of family members when requested by the provider based on indications of a physical or mental health issue.

G. Sponsored residential homes shall not also operate as group homes or Department of Social Services approved homes or foster homes.

H. The provider shall submit the name, address, and certification of the sponsored residential home to the department prior to adding the home. The provider shall submit the name and address of the sponsored residential home to the department prior to closing the home. The provider shall submit a service modification when approving homes more than 100 miles from the previously approved homes.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-1190 Sponsored residential home service policies

A. The provider shall implement written policies to provide orientation and supportive services to the sponsored residential home staff specific to the needs of the individuals receiving services.

B. The provider shall implement a training plan for the sponsor staff consistent with the needs of the individuals receiving services.

C. The provider shall specify staffing arrangements in all sponsored residential homes, including on-call and substitute care arrangements.

D. The provider shall implement a written policy on managing, monitoring, and supervising sponsored residential homes. This policy shall address changes in supervision arrangements as the number of homes increase.

E. The provider shall conduct inspections of each sponsored residential home other than his own. Inspections shall be performed at least on a quarterly basis during the year with at least two being unannounced inspections.

F. On an on-going basis and at least annually, the provider shall review and document compliance by each sponsored residential home and sponsor with regulations related to sponsored residential homes.

G. The provider shall develop written policies for terminating a sponsored residential home.

H. The provider shall document that all residents or their authorized representatives are provided the opportunity to choose a new placement when the current placement ends. Prior to moving an individual to another placement the provider shall conduct and document a meeting to include the individual and his authorized representative, if applicable, case manager, the current sponsor, and a receiving placement staff, if possible.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-1200 Supervision

A. The provider shall have a supervisor for every 15 sponsored residential homes where individuals are residing.

B. A responsible adult shall be available to provide supervision to the individual as specified in the individualized service plan.

C. Any member of the sponsor family who transports individuals receiving services must have a valid driver's license and automobile liability insurance. The vehicle used to transport individuals receiving services shall have a valid registration and inspection sticker.

D. The sponsor shall inform the provider in advance of any anticipated additions or changes in the sponsored residential home or as soon as possible after an unexpected change occurs.

E. In addition to the current reporting requirements the sponsor shall report all hospitalizations of individuals being served to the provider and the individual's case manager within 24 hours.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-1210 Sponsored residential home service records

Providers of sponsored residential home services shall maintain the following records on each sponsored residential home:

1. Documentation of three references for the owner of the sponsor home;

2. Criminal background checks and results of the search of the registry of founded complaints of child abuse and neglect for all adult employees in the home;

3. Orientation and training provided by the provider to the sponsor and employees;

4. The log of provider inspections of the sponsored residential home including the date, the employee conducting the inspection, the purpose of the inspection, and a description of any significant events or findings; and

5. The daily log maintained by the sponsor of significant events related to individuals receiving services.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-1220 Regulations pertaining to staff

Providers shall certify and document compliance of sponsors with regulations pertaining to staff.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-1230 Maximum number of beds or occupants in sponsored residential home

The maximum number of individuals served in a sponsored residential home is two. The maximum number of occupants in a sponsored residential home is seven.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-1235 Sponsored residential home services for children

In addition, the following requirements shall be met for homes serving children:

1. The provider shall develop a service description based upon evidence-based practices or an accepted therapeutic model of mental health, developmental or substance abuse services, or brain injury care for children.

2. The provider shall use a treatment team model consisting of staff who provide intensive support and consultation to the sponsor parents.

3. Weekly team meetings and supervision shall be held with the sponsor parent or parents to review progress on each case, review the daily behavioral information collected, and adjust the child's individualized services plan.

4. The sponsor parent or parents shall keep a daily log of behavioral and other child specific information and be available for daily Monday through Friday contact from the provider.

5. The sponsor parent or parents shall receive 25 hours per year of in-service training pertaining to providing services for the child they serve in addition to the training otherwise required in these regulations. The sponsor parent or parents shall also participate in ongoing training at least once a quarter.

6. The provider is not considered a child placing agency. Children are placed with the provider by licensed child placing agencies, local departments of social services, or parents.

7. The sponsor parent or parents shall be at least 25 years old.

8. The sponsor parent or parents shall be able to provide care and supervision during nonschool hours.

9. The provider shall have access through directly providing it or developing agreements for 24-hour emergency mental health care for children served with serious emotional disturbances .

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

Article 5 Case Management Services

12VAC35-105-1240 Service requirements for providers of case management services

Providers of case management services shall document that the services below are performed consistent with the individual's assessment and ISP.

1. Enhancing community integration through increased opportunities for community access and involvement and creating opportunities to enhance community living skills to promote community adjustment including, to the maximum extent possible, the use of local community resources available to the general public;

2. Making collateral contacts with the individual's significant others with properly authorized releases to promote implementation of the individual's individualized services plan and his community adjustment;

3. Assessing needs and planning services to include developing a case management individualized services plan;

4. Linking the individual to those community supports that are most likely to promote the personal habilitative or rehabilitative and life goals of the individual as developed in the ISP;

5. Assisting the individual directly to locate, develop, or obtain needed services, resources, and appropriate public benefits;

6. Assuring the coordination of services and service planning within a provider agency, with other providers, and with other human service agencies and systems, such as local health and social services departments;

7. Monitoring service delivery through contacts with individuals receiving services and service providers and periodic site and home visits to assess the quality of care and satisfaction of the individual;

8. Providing follow up instruction, education, and counseling to guide the individual and develop a supportive relationship that promotes the ISP;

9. Advocating for individuals in response to their changing needs, based on changes in the individualized services plan;

10. Planning for transitions in the individual's life;

11. Knowing and monitoring the individual's health status, any medical conditions, and his medications and potential side effects, and assisting the individual in accessing primary care and other medical services, as needed; and

12. Understanding the capabilities of services to meet the individual's identified needs and preferences and to serve the individual without placing the individual, other participants, or staff at risk of serious harm.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-1245 Case management direct assessments

Case managers shall meet with each individual face-to-face as dictated by the individual's needs. At face-to-face meetings, the case manager shall (i) observe and assess for any previously unidentified risks, injuries, needs, or other changes in status; (ii) assess the status of previously identified risks, injuries, or needs, or other changes in status; (iii) assess whether the individual's service plan is being implemented appropriately and remains appropriate for the individual; and (iv) assess whether supports and services are being implemented consistent with the individual's strengths and preferences and in the most integrated setting appropriate to the individual's needs.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 36, Issue 22, eff. August 1, 2020.

12VAC35-105-1250 Qualifications of case management employees or contractors

A. Employees or contractors providing case management services shall have knowledge of:

1. Services and systems available in the community including primary health care, support services, eligibility criteria and intake processes and generic community resources;

2. The nature of serious mental illness, developmental disability, substance abuse (substance use disorders), or co-occurring disorders depending on the individuals receiving services, including clinical and developmental issues;

3. Different types of assessments, including functional assessment, and their uses in service planning;

4. Treatment modalities and intervention techniques, such as behavior management, independent living skills training, supportive counseling, family education, crisis intervention, discharge planning, and service coordination;

5. Types of mental health, developmental, and substance abuse programs available in the locality;

6. The service planning process and major components of a service plan;

7. The use of medications in the care or treatment of the population served; and

8. All applicable federal and state laws and regulations and local ordinances.

B. Employees or contractors providing case management services shall have skills in:

1. Identifying and documenting an individual's need for resources, services, and other supports;

2. Using information from assessments, evaluations, observation, and interviews to develop service plans;

3. Identifying and documenting how resources, services, and natural supports such as family can be utilized to promote achievement of an individual's personal habilitative or rehabilitative and life goals; and

4. Coordinating the provision of services by diverse public and private providers.

C. Employees or contractors providing case management services shall have abilities to:

1. Work as team members, maintaining effective inter-agency and intra-agency working relationships;

2. Work independently performing position duties under general supervision; and

3. Engage in and sustain ongoing relationships with individuals receiving services.

D. Case managers serving individuals with developmental disability shall complete the DBHDS core competency-based curriculum within 30 days of hire.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 36, Issue 22, eff. August 1, 2020.

12VAC35-105-1255 Case manager choice

The provider shall implement a written policy describing how individuals are assigned case managers and how they can request a change of their assigned case manager.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

Article 6 Community Gero-Psychiatric Residential Services

12VAC35-105-1260 Admission criteria

An individual receiving community gero-psychiatric residential services shall have had a medical, psychiatric, and behavioral evaluation to determine that he cannot be appropriately cared for in a nursing home or other less intensive level of care but does not need inpatient care.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002.

12VAC35-105-1270 Physical environment requirements of community gero-psychiatric residential services

A. Providers shall be responsible for ensuring safe mobility and unimpeded access to programs or services by installing and maintaining ramps, handrails, grab bars, elevators, protective surfaces, and other assistive devices or accommodations as determined by periodic review of the needs of the individuals being served. Entries, doors, halls, and program areas, including bedrooms, must have adequate room to accommodate wheelchairs and allow for proper transfer of individuals. Single bedrooms shall have at least 100 square feet and multi-bed rooms shall have at least 80 square feet per individual.

B. Floors must have resilient, nonabrasive, and slip-resistant floor surfaces and floor coverings that promote mobility in areas used by individuals and promote maintenance of sanitary conditions.

C. Temperatures shall be maintained between 70°F and 80°F throughout resident areas.

D. Bathrooms, showers, and program areas must be accessible to individuals. There must be at least one bathing unit available by lift, door, or swivel-type tub.

E. Areas must be provided for quiet and for recreation.

F. Areas must be provided for charting, storing of administrative supplies, a utility room, employee hand washing, dirty linen, clean linen storage, clothes washing, and equipment storage.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-1280 Monitoring

Employees or contractors shall regularly monitor individuals in all areas of the residence to ensure safety.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-1290 Service requirements for providers of gero-psychiatric residential services

A. Providers shall provide mental health, nursing and rehabilitative services; medical and psychiatric services; and pharmaceutical services for each individual as specified in the ISP.

B. Providers shall provide crisis stabilization services.

C. Providers shall implement written policies and procedures that support an active program of mental health and behavioral management services directed toward assisting each individual to achieve outcomes consistent with the highest level of self-care, independence, and quality of life. Programming may be on-site or at another location in the community.

D. Providers shall implement written policies and procedures that respond to the nursing needs of each individual to achieve outcomes consistent with the highest level of self-care, independence, and quality of life. Providers shall be responsible for:

1. Providing each individual services to prevent clinically avoidable complications, including: skin care, dexterity and mobility, continence, hydration, and nutrition;

2. Giving each individual proper daily personal attention and care, including skin, nail, hair, and oral hygiene, in addition to any specific care ordered by the attending physician;

3. Dressing each individual in clean clothing and encouraging each individual to wear day clothing when out of bed;

4. Providing each individual tub or shower baths as often as needed, but not less than twice weekly or a sponge bath daily if the medical condition prohibits tub or shower baths;

5. Providing each individual appropriate pain management; and

6. Ensuring that each individual has his own personal utensils, grooming items, adaptive devices, and other personal belongings including those with sentimental value.

E. Providers shall integrate behavioral and mental health care and medical and nursing care in the ISP.

F. Providers shall have available nourishment between scheduled meals.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-1300 Staffing requirements for community gero-psychiatric residential services

A. Community gero-psychiatric residential services shall be under the direction of a:

1. Program director with experience in gero-psychiatric services;

2. Medical director; and

3. Director of clinical services who is a registered nurse with experience in gero-psychiatric services.

B. Providers shall provide qualified nursing supervisors, nurses, and certified nurse aides on all shifts, seven days per week, in sufficient number to meet the assessed nursing care and behavioral management needs determined by the ISPs.

C. Providers shall provide qualified staff for behavioral, psychosocial rehabilitation, rehabilitative, mental health, or recreational programming to meet the needs determined by the ISP. These services shall be under the direction of a registered nurse, licensed psychologist, licensed clinical social worker, or licensed therapist.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-1310 Interdisciplinary services planning team

A. At a minimum, a registered nurse, a licensed psychologist, a licensed social worker, a therapist (recreational, occupational or physical therapist), a pharmacist, and a psychiatrist shall participate in the development and review of the ISP. Other employees or contractors as appropriate shall be included.

B. The interdisciplinary services planning team shall meet to develop the ISP and review it quarterly. Members of the team shall be available for consultation on an as needed basis.

C. The interdisciplinary services planning team shall review the medications prescribed at least quarterly and consult with the primary care physician as needed.

D. The interdisciplinary services planning team shall integrate medical care plans prescribed by the primary care physician into the ISP and consult with the primary care physician as needed.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-1320 Employee or contractor qualifications and training

A. A nurse aide may be employed only if he is certified by the Board of Nursing. During the initial 120 days of employment, a nurse aide may be employed if he is enrolled full-time in a nurse aide education program approved by the Virginia Board of Nursing or has completed a nurse aide education program or competency testing.

B. All nursing employees or contractors, including certified nursing assistants, must have additional competency-based training in providing mental health services to geriatric individuals, including behavior management.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002.

12VAC35-105-1330 Medical director

Providers of community gero-psychiatric residential services shall employ or have a written agreement with one or more psychiatrists with training and experience in gero-psychiatric services to serve as medical director. The duties of the medical director shall include :

1. Responsibility for overall medical and psychiatric care;

2. Advising the program director and the director of clinical services on medical and psychiatric issues, including the criteria for residents to be admitted, transferred , or discharged;

3. Advising on the development, execution, and coordination of policies and procedures that have a direct effect upon the quality of medical, nursing, and psychiatric care delivered to individuals; and

4. Acting as liaison and consulting with the administrator and the primary care physician on matters regarding medical, nursing, and psychiatric care policies and procedures.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-1340 Physician services and medical care

A. Each individual in a community gero-psychiatric residential service shall be under the care of a primary care physician. Nurse practitioners and physician assistants licensed to practice in Virginia may provide care in accordance with their practice agreements. Prior to, or at the time of admission, each individual, his authorized representative, or the entity responsible for his care shall designate a primary care physician.

B. The primary care physician shall conduct a physical examination at the time of admission or within 72 hours of admission into a community gero-psychiatric residential service. The primary care physician shall develop, in coordination with the interdisciplinary services planning team, a medical care plan of treatment for an individual.

C. All physicians or other prescribers shall review all medication orders at least every 60 days or whenever there is a change in medication.

D. The provider shall have a signed agreement with a local general hospital describing back-up and emergency medical care plans.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-1350 Pharmacy services for providers of community gero-psychiatric residential services

A. The provider shall make provision for 24-hour emergency pharmacy services.

B. The provider shall have a written agreement with a qualified pharmacist to provide consultation on all aspects of the provision of pharmacy services and for regular visits, at least monthly.

C. A pharmacist licensed by the Virginia Board of Pharmacy shall review each individual's medication regimen. Any irregularities identified by the pharmacist shall be reported to the physician and the director of clinical services, and their response documented.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002.

Article 7 Assertive Community Treatment Service (ACT)

12VAC35-105-1360 Admission and discharge criteria

A. Individuals must meet the following admission criteria:

1. Diagnosis of a severe and persistent mental illness, predominantly schizophrenia, other psychotic disorder, or bipolar disorder that seriously impairs functioning in the community. Individuals with a sole diagnosis of a substance use disorder or developmental disability , personality disorder, traumatic brain injury, or an autism spectrum disorder are not the intended service recipients and should not be referred to ACT if they do not have a co-occurring psychiatric disorder.

2. Significant challenges to community integration without intensive community support including persistent or recurrent difficulty with one or more of the following:

a. Performing practical daily living tasks;

b. Maintaining employment at a self-sustaining level or consistently carrying out homemaker roles; or

c. Maintaining a safe living situation.

3. High service needs indicated due to one or more of the following:

a. Residence in a state hospital or other psychiatric hospital but clinically assessed to be able to live in a more independent situation if intensive services were provided or anticipated to require extended hospitalization, if more intensive services are not available;

b. Multiple admissions to or at least one recent long-term stay (30 days or more) in a state hospital or other acute psychiatric hospital inpatient setting within the past two years; or a recent history of more than four interventions by psychiatric emergency services per year;

c. Persistent or very recurrent severe major symptoms (e.g., affective, psychotic, suicidal);

d. Co-occurring substance addiction or abuse of significant duration (e.g., greater than six months);

e. High risk or a recent history (within the past six months) of criminal justice involvement (e.g., arrest or incarceration);

f. Ongoing difficulty meeting basic survival needs or residing in substandard housing, homeless, or at imminent risk of becoming homeless; or

g. Inability to consistently participate in traditional office-based services.

B. Individuals receiving ACT services should not be discharged for failure to comply with treatment plans or other expectations of the provider, except in certain circumstances as outlined. Individuals must meet at least one of the following criteria to be discharged:

1. Change in the individual's residence to a location out of the service area;

2. Incarceration of the individual for a period to exceed a year or long-term hospitalization (more than one year); however, the provider is expected to prioritize these individuals for ACT services upon the individual's anticipated return to the community if the individual wishes to return to services and the service level is appropriate to his needs;

3. The individual and, if appropriate, the legally responsible person, choose to withdraw from services and documented attempts by the program to re-engage the individual with the service have not been successful; or

4. The individual and team determine that ACT services are no longer needed based on the attainment of goals as identified in the person centered plan and a less intensive level of care would adequately address current goals.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 36, Issue 22, eff. August 1, 2020; Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1370 Treatment team and staffing plan

A. ACT services are delivered by interdisciplinary teams.

1. ACT teams shall have sufficient staffing composition to meet the varying needs of individuals served by the team as required by this section. Each ACT team shall meet the following minimum position and staffing requirements:

a. Team leader. There shall be one full-time LMHP with three years of work experience in the provision of mental health services to adults with serious mental illness; a resident who is under the supervision of a licensed professional counselor in accordance with 18VAC115-20-10 and who is registered with the Virginia Board of Counseling with three years of experience in the provision of mental health services to adults with serious mental illness; a resident in psychology who is under supervision of a licensed clinical psychologist and is registered with the Virginia Board of Psychology in accordance with 18VAC125-20-10 and who has three years of experience in the provision of mental health services to adults with serious mental illness; a supervisee in social work who is under the supervision of a licensed clinical social worker and who is registered with the Virginia Board of Social Work in accordance with 18VAC140-20-10 and who has three years of experience in the provision of mental health services to adults with serious mental illness; or one full-time registered QMHP with at least three years of experience in the provision of collaborative behavioral health services to adults with serious mental illness who was employed by the provider as a team leader prior to July 1, 2020. The team leader shall oversee all aspects of team operations and shall provide direct services to individuals in the community.

b. Nurses. ACT nurses shall be full-time employees or contractors with the following minimum qualifications: a registered nurse shall have one year of experience in the provision of mental health services to adults with serious mental illness, or a licensed practical nurse shall have three years of experience in the provision of mental health services to adults with serious mental illness.

(1) Small ACT teams shall have at least one full-time nurse, who shall be either an RN or an LPN;

(2) Medium ACT teams shall have at least one full-time RN and at least one additional full-time nurse who shall be an LPN or RN; and

(3) Large ACT teams shall have at least one full-time RN and at least two additional full-time nurses who shall be LPNs or RNs.

c. Vocational specialist. There shall be one or more full-time vocational specialist, who shall be a registered QMHP with demonstrated expertise in vocational services through experience or education.

d. Co-occurring disorder specialist. There shall be one or more full-time co-occurring disorder specialists, who shall be a LMHP; a resident who is under the supervision of a licensed professional counselor in accordance with 18VAC115-20-10 and who is registered with the Virginia Board of Counseling; a resident in psychology who is under supervision of a licensed clinical psychologist and is registered with the Virginia Board of Psychology in accordance with 18VAC125-20-10; a supervisee in social work who is under the supervision of a licensed clinical social worker and who is registered with the Virginia Board of Social Work in accordance with 18VAC140-20-10; registered QMHP; or a certified substance abuse specialist (CSAC) with training or experience working with adults with co-occurring serious mental illness and substance use disorder.

e. ACT peer specialists. There shall be one full-time equivalent peer recovery specialists who is or has been a recipient of mental health services for severe and persistent mental illness. The peer specialist shall be certified as a peer recovery specialist in accordance with 12VAC35-250 or shall become certified in the first year of employment. The peer specialist shall be a fully integrated team member who provides peer support directly to individuals and provides leadership to other team members in understanding and supporting each individual's recovery goals.

f. Program assistant. There shall be one full-time or two part-time program assistants with skills and abilities in medical records management who shall operate and coordinate the management information system, maintain accounts and budget records for individual and program expenditures, and perform administrative support activities.

g. Psychiatric care provider. There shall be one physician who is board certified in psychiatry or who is board eligible in psychiatry and is licensed to practice medicine in Virginia or a psychiatric nurse practitioner practicing within the scope of practice as defined in 18VAC90-30-120. An equivalent ratio of 16 hours of psychiatric time per 50 individuals served must be maintained. The psychiatric care provider shall be a fully integrated team member who attends team meetings and actively participates in developing and implementing each individual ISP.

h. Generalist clinical staff. There shall be additional clinical staff with the knowledge, skill, and ability required, based on the population and age of individuals being served, to carry out rehabilitation and support functions, at least 50% of whom shall be LMHPs, QMHPs, QMHP-Ts, or QPPMHs.

(1) Small ACT teams shall have at least one generalist clinical staff;

(2) Medium ACT teams shall have at least two generalist clinical staff; and

(3) Large ACT teams shall have at least three generalist clinical staff.

2. Staff-to-individual ratios for ACT Teams:

a. Small ACT teams shall maintain a caseload of no more than 50 individuals and shall maintain at least one staff member per eight individuals, in addition to a psychiatric care provider and a program assistant.

b. Medium ACT teams shall maintain a caseload of no more than 74 individuals and shall maintain at least one staff member per nine individuals, in addition to a psychiatric care provider and a program assistant.

c. Large ACT teams shall maintain a caseload of no more than 120 individuals and shall maintain at least one staff member per nine individuals, in addition to a psychiatric care provider and a program assistant.

B. ACT teams shall be available to individuals 24 hours per day and shall operate a minimum of 12 hours each weekday and eight hours each weekend day and each holiday.

C. The ACT team shall make crisis services directly available 24 hours a day but may arrange coverage through another crisis services provider if the team coordinates with the crisis services provider daily.

D. The ACT team shall operate an after-hours on-call system and shall be available to individuals by telephone and in person when needed as determined by the team.

E. ACT teams in development may submit a transition plan to the department for approval that will allow for "start-up" when newly forming teams are not in full compliance with the ACT model relative to staffing patterns and individuals receiving services capacity. Approved transition plans shall be limited to a six-month period.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 35, Issue 19, eff. June 15, 2019; Volume 39, Issue 11, eff. February 17, 2023; Volume 40, Issue 22, eff. July 17, 2024; Volume 41, Issue 20, eff. June 18, 2025.

12VAC35-105-1380 Contacts

A. The ACT team shall provide multiple contacts per week to individuals experiencing severe symptoms or significant problems in daily living.

B. Each individual receiving ACT services shall be seen face-to-face by an employee or contractor as specified in the individual's ISP. Providers shall document all attempts to make contact, and if contact is not made, the reasons why contact was not made.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1390 ACT service daily operation and progress notes

A. ACT teams shall conduct organizational meetings Monday through Friday at least four days per week at a regularly scheduled time to review the status of all individuals and the outcome of the most recent employee or contractor contact, assign daily and weekly tasks to employees and contractors, revise treatment plans as needed, plan for emergency and crisis situations, and to add service contacts that are identified as needed.

B. A daily log that provides a roster of individuals served in the ACT services program and documentation of services provided and contacts made with them shall be maintained and utilized in the team meeting. Daily logs shall not be considered progress notes.

C. There shall also be individual progress notes documenting services provided in accordance with the ISP each time the individual receives services, which shall be included within the individual's record. ACT teams shall also document within the individual's record attempts at outreach and engagement.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1400 ACT assessment

The provider shall solicit the individual's own assessment of his needs, strengths, goals, preferences, and abilities to identify the need for recovery oriented treatment, rehabilitation, and support services and the status of his environmental supports within the individual's cultural context. With the participation of the individual, the provider shall assess:

1. Psychiatric history, mental status and diagnosis, including the content of an advance directive;

2. Medical, dental, and other health needs;

3. Extent and effect of drug or alcohol use;

4. Education and employment, including current daily structured use of time, school or work status, interests and preferences, and supports and barriers to educational and employment performance;

5. Social development and functioning, including childhood and family history, religious beliefs, leisure interests, and social skills;

6. Housing and daily living skills, including the support needed to obtain and maintain decent, affordable housing integrated into the broader community; the current ability to meet basic needs such as personal hygiene, food preparation, housekeeping, shopping, money management, and the use of public transportation and other community based resources;

7. Family and social network, including the current scope and strength of an individual's network of family, peers, friends, and co-workers, and their understanding and expectations of the team's services;

8. Finances and benefits, including the management of income, the need for and eligibility for benefits, and the limitations and restrictions of those benefits; and

9. Legal and criminal justice involvement, including guardianship, commitment, representative payee status, and experience as either a victim or an accused person.

History

• Statutory Authority: § 37.2-203 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-1410 Service requirements

ACT teams shall document that the following services are provided consistent with the individual's assessment and ISP.

1. Ongoing assessment to ascertain the needs, strengths, and preferences of the individual;

2. Case management;

3. Nursing;

4. Support for wellness self-management, including the development and implementation of individual recovery plans, symptom assessment, and recovery education;

5. Psychopharmacological treatment, administration, and monitoring;

6. Co-occurring diagnosis substance use disorder services that are nonconfrontational, trauma informed, person-centered, consider interactions of mental illness and substance use, and have goals determined by the individual;

7. Empirically supported interventions and psychotherapy;

8. Psychiatric rehabilitation, which may include skill-building, coaching, and facilitating access to necessary resources to help individuals with personal care, safety skills, money management, grocery shopping, cooking, food safety and storage, purchasing and caring for clothing, household maintenance and cleaning skills, social skills, and use of transportation and other community resources;

9. Work-related services that follow evidence-based supported employment principles, such as direct assistance with job development, locating preferred jobs, assisting the individual through the application process, and communicating with employers;

10. Support for resuming education;

11. Support, education, consultation, and skill-teaching to family members , significant others, and broader natural support systems, which shall be directed exclusively to the well-being and benefit of the individual;

12. Collaboration with families and development of family and other natural supports;

13. Assistance in obtaining and maintaining safe, decent, and affordable housing that follows the individual's preferences in level of independence and location, consistent with an evidence-based supportive housing model;

14. Direct support to help individuals obtain legal and advocacy services, financial support, money-management services, medical and dental services, transportation, and natural supports in the community;

15. Crisis assessment, interventions to prevent or resolve potential crises, and admission to and discharge from psychiatric hospitals;

16. Assistance in developing and maintaining natural supports and social relationships;

17. Medication education, assistance, and support; and

18. Peer support services, such as coaching, mentoring, assistance with self-advocacy and self-direction, and modeling recovery practices.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1420 (Reserved.)

Article 1 Medically Managed Intensive Inpatient Level of care 4.0

12VAC35-105-1430 Medically managed intensive inpatient Level of care 4.0 staff criteria

A medically managed intensive inpatient program shall meet the following staff requirements:

1. Have a team of appropriately trained and credentialed professionals who provide medical management by physicians 24 hours a day, primary nursing care and observation 24 hours a day, and professional counseling services 16 hours a day;

2. Have an interdisciplinary team of appropriately credentialed clinical staff, which may include addiction-credentialed physicians, nurse practitioners, physician assistants, nurses, counselors, psychologists, and social workers, who assess and treat individuals with severe substance use disorders or addicted individuals with concomitant acute biomedical, emotional, or behavioral disorders;

3. Have staff who are knowledgeable about the biopsychosocial dimensions of addiction as well as biomedical, emotional, behavioral, and cognitive disorders;

4. Have facility-approved addiction counselors or licensed, certified, or registered addiction clinicians who administer planned interventions according to the assessed needs of the individual; and

5. All clinical staff shall be qualified by training and experience and appropriately licensed, certified, or registered by the appropriate health regulatory board to serve individuals admitted to the service.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1440 Medically managed intensive inpatient Level of care 4.0 program criteria

A medically managed intensive inpatient program shall meet the following programmatic requirements. The program shall:

1. Deliver services in a 24-hour medically managed, acute care setting and shall be available to all individuals within that setting;

2. Provide cognitive, behavioral, motivational, pharmacologic, and other therapies provided on an individual or group basis, depending on the individual's needs;

3. Provide, for the individual who has a severe biomedical disorder, physical health interventions to supplement addiction treatment;

4. Provide, for the individual who has stable psychiatric symptoms, individualized treatment activities designed to monitor the individual's mental health;

5. Provide planned clinical interventions that are designed to enhance the individual's understanding and acceptance of his addiction illness;

6. Provide family and caregiver treatment services as deemed appropriate by a licensed professional and included in an assessment and treatment plan;

7. Provide health education services;

8. Make medication assisted treatment (MAT) available for all individuals admitted to the service. MAT may be provided by facility staff or coordinated through alternative resources; and

9. Comply with 12VAC35-105-1055 through 12VAC35-105-1130.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1450 Medically managed intensive inpatient Level of care 4.0 admission criteria

Before a medically managed intensive inpatient program may admit an individual, the individual shall meet the criteria for admission as defined by the provider's policies. The provider's policy regarding admission shall at a minimum require the individual to:

1. Meet diagnostic criteria for a substance use disorder or substance induced disorder as defined by the DSM; and

2. Meet the admission criteria of Level 4.0 of ASAM, including the specific criteria for adult and adolescent populations.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1460 Medically managed intensive inpatient Level of care 4.0 discharge criteria

Before a medically managed intensive inpatient program may discharge or transfer an individual, the individual shall meet the criteria for discharge or transfer as defined by the provider's policies, which shall include provisions for the discharge or transfer of individuals who have:

1. Achieved the goals of the treatment services and no longer require ASAM 4.0 level of care;

2. Been unable to achieve the goals of the individual's treatment but could achieve the individual's goals with a different type of treatment; or

3. Achieved the individual's original treatment goals but have developed new treatment challenges that can only be adequately addressed in a different type of treatment.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1470 Medically managed intensive inpatient Level of care 4.0 co-occurring enhanced programs

A. Medically managed intensive inpatient co-occurring enhanced programs shall be staffed by appropriately credentialed mental health professionals who assess and treat the individual's co-occurring mental disorders. All clinical staff shall be qualified by training and experience and appropriately licensed, certified, or registered by the appropriate health regulatory board to serve individuals admitted to the service.

B. Medically managed intensive inpatient co-occurring enhanced programs shall offer individualized treatment activities designed to stabilize the individual's active psychiatric symptoms, including medication evaluation and management.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

Article 2 Medically Monitored Intensive Inpatient Services Level of care 3.7

12VAC35-105-1480 Medically monitored intensive inpatient services Level of care 3.7 staff criteria

A medically monitored intensive inpatient treatment program shall meet the following staff requirements. The program shall:

1. Have a licensed physician to oversee the treatment process and ensure quality of care. A physician, a licensed nurse practitioner, or a licensed physician assistant shall be available 24 hours a day in person or by telephone. A physician, a licensed nurse practitioner, or a licensed physician assistant shall assess the individual in person within 24 hours of admission;

2. Offer 24-hour nursing care and conduct a nursing assessment on admission. The level of nursing care must be appropriate to the severity of needs of individuals admitted to the service;

3. Have interdisciplinary staff, which may include physicians, nurses, addiction counselors, and behavioral health specialists who are able to assess and treat the individual and obtain and interpret information regarding the individual's psychiatric and substance use or addictive disorders;

4. Offer daily onsite counseling and clinical services. Clinical staff shall be knowledgeable about the biological and psychosocial dimensions of addiction and other behavioral health disorders with specialized training in behavior management techniques and evidence-based practices;

5. Have staff able to provide a planned regimen of 24-hour professionally directed evaluation, care, and treatment services;

6. Make MAT available for all individuals with opioid use disorder or alcohol use disorder. MAT may be provided by facility staff or coordinated through alternative resources; and

7. Ensure all clinical staff are qualified by training and experience and appropriately licensed, certified, or registered by the appropriate health regulatory board to serve individuals admitted to the service.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1490 Medically monitored intensive inpatient services Level of care 3.7 program criteria

A medically monitored intensive inpatient treatment program shall meet the following programmatic requirements. The program shall:

1. Be made available to all individuals within the inpatient setting;

2. Provide a combination of individual and group therapy as deemed appropriate by a credentialed addiction treatment professional and included in an assessment and treatment plan. Such therapy shall be adapted to the individual's level of comprehension;

3. Make available medical and nursing services onsite to provide ongoing assessment and care of addiction needs;

4. Provide direct affiliations with other easily accessible levels of care or close coordination through referral to more or less intensive levels of care and other services;

5. Provide family and caregiver treatment services as deemed appropriate by a credentialed addiction treatment professional and included in an assessment and treatment plan;

6. Provide educational and informational programming adapted to individual needs. The educational and informational programming shall include materials designed to enhance the individual's understanding of addiction and may include peer recovery support services as appropriate;

7. Utilize random drug screening to monitor drug use and reinforce treatment gains;

8. Regularly monitor the individual's adherence in taking any prescribed medications; and

9. Comply with 12VAC35-105-1055 through 12VAC35-105-1130.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1500 Medically monitored intensive inpatient Level of care 3.7 admission criteria

Before a medically monitored intensive inpatient program may admit an individual, the individual shall meet the criteria for admission as defined by the provider's policies. The provider's policy regarding admission shall at a minimum require the individual to:

1. Meet diagnostic criteria for a moderate or severe substance use or addictive disorder; and

2. Meet the admission criteria of Level 3.7 of ASAM, including the specific criteria for adult and adolescent populations.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1510 Medically monitored intensive inpatient Level of care 3.7 discharge criteria

A. Before a medically monitored intensive inpatient program may discharge or transfer an individual, the individual shall meet the criteria for discharge or transfer as defined by the provider's policies, which shall include provisions for the discharge or transfer of individuals who have:

1. Achieved the goals of the treatment services and no longer require ASAM 3.7 level of care;

2. Been unable to achieve the goals of the individual's treatment but could achieve the individual's goals with a different type of treatment; or

3. Achieved the individual's original treatment goals but have developed new treatment challenges that can only be adequately addressed in a different type of treatment.

B. Discharge planning shall occur for individuals and include realistic plans for the continuity of MAT services as indicated.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1520 Medically monitored intensive inpatient Level of care 3.7 co-occurring enhanced programs

A. Medically monitored intensive inpatient co-occurring enhanced programs shall offer psychiatric services, medication evaluation, and laboratory services as indicated by the needs of individuals admitted to the service. A psychiatrist shall assess the individual by telephone within four hours of admission and in person with 24 hours following admission. A credentialed addiction treatment professional shall conduct a behavioral health-focused assessment at the time of admission. A registered nurse shall monitor the individual's progress and administer or monitor the individual's self-administration of psychotropic medications.

B. Medically monitored intensive inpatient co-occurring enhanced programs shall be staffed by addiction psychiatrists and appropriately credentialed behavioral health professionals who are able to assess and treat co-occurring psychiatric disorders and who have specialized training in behavior management techniques and evidence based practices. All clinical staff shall be qualified by training and experience and appropriately licensed, certified, or registered by the appropriate health regulatory board to serve individuals admitted to the service.

C. Medically monitored intensive inpatient co-occurring enhanced programs shall offer planned clinical activities designed to promote stabilization of the individual's behavioral health needs and psychiatric symptoms and to promote such stabilization, including medication education and management and motivational and engagement strategies.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

Article 3 Clinically Managed High-Intensity Residential Services Level of care 3.5

12VAC35-105-1530 Clinically managed high-intensity residential services Level of care 3.5 staff criteria

A clinically managed high-intensity residential care program shall meet the following staff requirements. The program shall:

1. Offer telephone or in-person consultation with a physician, a licensed nurse practitioner, or a licensed physician assistant in case of emergency related to an individual's substance use disorder 24 hours a day seven days a week;

2. Offer onsite 24-hour-a-day clinical staffing by credentialed addiction treatment professionals in addition to other allied health professionals, such as peer recovery specialists, who work in an interdisciplinary team;

3. Have clinical staff knowledgeable about the biological and psychosocial dimensions of substance use and mental health disorders and their treatment. Staff shall be able to identify the signs and symptoms of acute psychiatric conditions. Staff shall have specialized training in behavior management techniques; and

4. Ensure that all clinical staff are qualified by training and experience and appropriately licensed, certified, or registered by the appropriate health regulatory board to serve individuals admitted to the service.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1540 Clinically managed high-intensity residential services Level of care 3.5 program criteria

A clinically managed high-intensity residential care program shall meet the following programmatic requirements. The program shall:

1. Provide daily clinical services, including a range of cognitive, behavioral, and other therapies in individual or group therapy; programming; and psychoeducation as deemed appropriate by a credentialed addiction treatment professional and included in an assessment and treatment plan;

2. Provide counseling and clinical interventions to teach an individual the skills needed for daily productive activity, prosocial behavior, and reintegration into family and community;

3. Provide motivational enhancement and engagement strategies appropriate to an individual's stage of readiness to change and level of comprehension;

4. Have direct affiliations with other easily accessible levels of care or provide coordination through referral to more or less intensive levels of care and other services;

5. Provide family and caregiver treatment services as deemed appropriate by a credentialed addiction treatment professional and included in an assessment and treatment plan;

6. Provide educational, vocational, and informational programming adaptive to individual needs;

7. Utilize random drug screening to monitor progress and reinforce treatment gains as appropriate to an individual treatment plan;

8. Ensure and document that the length of an individual's stay shall be determined by the individual's condition and functioning;

9. Make a substance use treatment program available for all individuals; and

10. Make MAT available for all individuals with opioid use disorder or alcohol use disorder. Medication assisted treatment may be provided by facility staff, or coordinated through alternative resources.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1550 Clinically managed high-intensity residential services Level of care 3.5 admission criteria

A. The individuals served by a clinically managed high-intensity residential care program are individuals who are not sufficiently stable to benefit from outpatient treatment regardless of intensity of service.

B. Before a clinically managed high-intensity residential service program may admit an individual, the individual shall meet the criteria for admission as defined by the provider's policies. The provider's policy regarding admission shall at a minimum require the individual to:

1. Meet diagnostic criteria for a substance use disorder or addictive disorder of moderate to high severity as defined by the DSM; and

2. Meet the admission criteria of Level 3.5 of ASAM.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1560 Clinically managed high-intensity residential services Level of care 3.5 discharge criteria

Before a clinically managed high-intensity residential service program may discharge or transfer an individual, the individual shall meet the criteria for discharge or transfer as defined by the provider's policies, which shall include provisions for the discharge or transfer of individuals who have:

1. Achieved the goals of the treatment services and no longer require ASAM 3.5 level of care;

2. Been unable to achieve the goals of the individual's treatment but could achieve the individual's goals with a different type of treatment; or

3. Achieved the individual's original treatment goals but have developed new treatment challenges that can only be adequately addressed in a different type of treatment.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1570 Clinically managed high-intensity residential services Level of care 3.5 co-occurring enhanced programs

A. Clinically managed high-intensity residential services co-occurring enhanced programs shall offer psychiatric services, medication evaluation, and laboratory services. Such services shall be available by telephone within eight hours and onsite or closely coordinated offsite within 24 hours.

B. Clinically managed high-intensity residential services co-occurring enhanced programs shall be staffed by appropriately credentialed mental health professionals, including addiction psychiatrists who are able to assess and treat co-occurring mental disorders and who have specialized training in behavior management techniques. All clinical staff shall be qualified by training and experience and appropriately licensed, certified, or registered by the appropriate health regulatory board to serve individuals admitted to the service.

C. Clinically managed high-intensity residential services co-occurring enhanced programs shall offer planned clinical activities designed to stabilize the individual's mental health problems and psychiatric symptoms and to maintain such stabilization, including medication education and management and motivational and engagement strategies. Goals of therapy shall apply to both the individual's substance use disorder and any co-occurring mental disorder.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

Article 4 Clinically Managed Population-Specific High Intensity Residential Services Level of care 3.3

12VAC35-105-1580 Clinically managed population-specific high-intensity residential services Level of care 3.3 staff criteria

A clinically managed, population-specific, high-intensity residential services program shall meet the following staff requirements. The program shall:

1. Offer telephone or in-person consultation with a physician, a licensed nurse practitioner, or a physician assistant in case of emergency related to an individual's substance use disorder 24 hours a day, seven days a week;

2. Have allied health professional staff onsite 24 hours a day. At least one clinician with competence in the treatment of substance use disorder shall be available onsite or by telephone 24 hours a day;

3. Have clinical staff knowledgeable about the biological and psychosocial dimensions of substance use and mental health disorders and their treatment and able to identify the signs and symptoms of acute psychiatric conditions. Staff shall have specialized training in behavior management techniques; and

4. Ensure all clinical staff are qualified by training and experience and appropriately licensed, certified, or registered by the appropriate health regulatory board to serve individuals admitted to the service.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1590 Clinically managed population-specific high-intensity residential services Level of care 3.3 program criteria

A clinically managed, population-specific, high-intensity residential services program shall meet the following programmatic requirements. The program shall:

1. Provide daily clinical services that shall include a range of cognitive, behavioral, and other therapies administered on an individual and group basis, medication education and management, educational groups, and occupational or recreation activities as deemed appropriate by a credentialed addiction treatment professional and included in an assessment and treatment plan;

2. Provide daily professional addiction and mental health treatment services that may include relapse prevention, exploring interpersonal choices, peer recovery support, and development of a social network;

3. Provide services to improve the individual's ability to structure and organize the tasks of daily living and recovery. Such services shall accommodate the cognitive limitations within this population;

4. Make available medical, psychiatric, psychological, and laboratory and toxicology services through consultation or referral as indicated by the individual's condition;

5. Provide case management, including ongoing transition and continuing care planning;

6. Provide motivational interventions appropriate to the individual's stage of readiness to change and designed to address the individual's functional limitations;

7. Have direct affiliations with other easily accessible levels of care or coordinate through referral to more or less intensive levels of care and other services;

8. Provide family and caregiver treatment services as deemed appropriate by an assessment and treatment plan;

9. Utilize random drug screening to monitor progress and reinforce treatment gains;

10. Regularly monitor the individual's adherence to taking prescribed medications;

11. Make the substance use treatment program available to all individuals served by the residential care service; and

12. Make MAT available for all individuals with opioid use disorder or alcohol use disorder. Medication assisted treatment may be provided by facility staff or coordinated through alternative resources.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1600 Clinically managed population-specific high-intensity residential services Level of care 3.3 admission criteria

Before a clinically managed, population-specific, high-intensity residential service program may admit an individual, the individual shall meet the criteria for admission as defined by the provider's policies. The provider's policy regarding admission shall at a minimum require the individual to:

1. Meet diagnostic criteria for a moderate or severe substance use or addictive disorder as defined by the DSM; and

2. Meet the admission criteria of Level 3.3 of ASAM.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1610 Clinically managed population-specific high-intensity residential services Level of care 3.3 discharge criteria

A. Before a clinically managed, population-specific, high-intensity residential service program may discharge or transfer an individual, the individual shall meet the criteria for discharge or transfer as defined by the provider's policies, which shall include provisions for the discharge or transfer of individuals who have:

1. Achieved the goals of the treatment services and no longer require ASAM 3.3 level of care;

2. Been unable to achieve the goals of the individual's treatment but could achieve the individual's goals with a different type of treatment; or

3. Achieved the individual's original treatment goals but have developed new treatment challenges that can only be adequately addressed in a different type of treatment.

B. Discharge planning shall occur for individuals and include realistic plans for the continuity of MAT services as indicated.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1620 Clinically managed population-specific high-intensity residential services Level of care 3.3 co-occurring enhanced programs

A. Clinically managed population-specific high-intensity residential services co-occurring enhanced programs shall offer psychiatric services, medication evaluation, and laboratory services. Such services shall be available by telephone within eight hours and onsite or closely coordinated offsite within 24 hours, as appropriate to the severity and urgency of the individual's mental condition.

B. Clinically managed population-specific high-intensity residential services co-occurring enhanced programs shall be staffed by appropriately credentialed psychiatrists and licensed mental health professionals who are able to assess and treat co-occurring mental disorders and who have specialized training in behavior management techniques. All clinical staff shall be qualified by training and experience and appropriately licensed, certified, or registered by the appropriate health regulatory board to serve individuals admitted to the service.

C. Clinically managed population-specific high-intensity residential services co-occurring enhanced programs shall offer planned clinical activities designed to stabilize the individual's mental health problems and psychiatric symptoms and to maintain such stabilization, including medication education and management and motivational and engagement strategies. Goals of therapy shall apply to both the substance use disorder and any co-occurring mental health disorder.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

Article 5 Clinically Managed Low-Intensity Residential Services Level of care 3.1

12VAC35-105-1630 Clinically managed low-intensity residential services Level of care 3.1 staff criteria

A clinically managed low-intensity residential services program shall meet the following staff requirements. The program shall:

1. Offer telephone or in-person consultation with a physician in case of emergency related to an individual's substance use disorder, available 24 hours a day, seven days a week. The program shall also provide allied health professional staff onsite 24 hours a day;

2. Have clinical staff who are knowledgeable about the biological and psychosocial dimensions of substance use disorder and their treatment and are able to identify the signs and symptoms of acute psychiatric conditions;

3. Have a team comprised of appropriately trained and credentialed medical, addiction, and mental health professionals; and

4. Ensure all clinical staff are qualified by training and experience and appropriately licensed, certified, or registered by the appropriate health regulatory board to serve individuals admitted to the service.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1640 Clinically managed low-intensity residential services Level of care 3.1 program criteria

A clinically managed low-intensity residential services program shall meet the following programmatic requirements. The program shall:

1. Offer a minimum of five hours a week of professionally directed treatment in addition to other treatment services offered to individuals, such as partial hospitalization or intensive outpatient treatment the focus of which is stabilizing the individual's substance use disorder. Services shall be designed to improve the individual's ability to structure and organize the tasks of daily living and recovery;

2. Ensure collaboration with care providers to develop an individual treatment plan for each individual with time-specific goals and objectives;

3. Provide counseling and clinical monitoring to support successful initial involvement in regular, productive daily activity;

4. Provide case management services;

5. Provide motivational interventions appropriate to the individual's stage of readiness to change and level of comprehension;

6. Have direct affiliations with other easily accessible levels of care or coordinate through referral to more or less intensive levels of care and other services;

7. Include the ability to arrange for needed procedures as appropriate to the severity and urgency of the individual's condition;

8. Provide family and caregiver treatment and peer recovery support services as deemed appropriate by a licensed professional and included in an assessment and treatment plan;

9. Provide addiction pharmacotherapy and the ability to arrange for pharmacotherapy for psychiatric medications;

10. Utilize random drug screening to monitor progress and reinforce treatment gains;

11. Make a substance abuse treatment program available to all individuals; and

12. Make MAT available for all individuals with opioid use disorder and alcohol use disorder. Medication assisted treatment may be provided by facility staff or coordinated through alternative resources.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1650 Clinically managed low-intensity residential services Level of care 3.1 admission criteria

Before a clinically managed low-intensity residential service program may admit an individual, the individual shall meet the criteria for admission as defined by the provider's policies. The provider's policy regarding admission shall at a minimum require the individual to:

1. Meet diagnostic criteria for a moderate or severe substance use or addictive disorder as defined by the DSM; and

2. Meet the admission criteria of Level 3.1 of ASAM.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1660 Clinically managed low-intensity residential services Level of care 3.1 discharge criteria

Before a clinically managed low-intensity residential services program may discharge or transfer an individual, the individual shall meet the criteria for discharge or transfer as defined by the provider's policies, which shall include provisions for the discharge or transfer of individuals who have:

1. Achieved the goals of the treatment services and no longer require ASAM 3.1 level of care;

2. Been unable to achieve the goals of the individual's treatment but could achieve the individual's goals with a different type of treatment; or

3. Achieved the individual's original treatment goals but have developed new treatment challenges that can only be adequately addressed in a different type of treatment.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1670 Clinically managed low-intensity residential services Level of care 3.1 co-occurring enhanced programs

A. Clinically managed low-intensity residential services co-occurring enhanced programs shall offer psychiatric services, including medication evaluation and laboratory services. Such services shall be provided onsite or closely coordinated offsite, as appropriate to the severity and urgency of the individual's mental condition.

B. Clinically managed low-intensity residential services co-occurring enhanced programs shall be staffed by appropriately credentialed licensed mental health professionals who are able to assess and treat co-occurring disorders with the capacity to involve addiction-trained psychiatrists. All clinical staff shall be qualified by training and experience and appropriately licensed, certified, or registered by the appropriate health regulatory board to serve individuals admitted to the service.

C. Clinically managed low-intensity residential services co-occurring enhanced programs shall offer planned clinical activities that are designed to stabilize the individual's mental health problems and psychiatric symptoms and to maintain such stabilization, including medication education and management and motivational and engagement strategies. Goals of therapy shall apply to both the substance use disorder and any co-occurring mental disorder.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

Article 6 Partial Hospitalization Level of care 2.5

12VAC35-105-1680 Substance abuse partial hospitalization services Level of care 2.5 staff criteria

A substance abuse partial hospitalization program shall meet the following staff requirements. The program shall:

1. Have an interdisciplinary team of addiction treatment professionals, which may include counselors, psychologists, social workers, and addiction-credentialed physicians. Physicians treating individuals in this level shall have specialty training or experience in addiction medicine;

2. Have staff able to obtain and interpret information regarding the individual's biopsychosocial needs;

3. Have staff trained to understand the signs and symptoms of mental disorders and to understand and be able to explain the uses of psychotropic medications and their interactions with substance-related disorders; and

4. Ensure all clinical staff are qualified by training and experience and appropriately licensed, certified, or registered by the appropriate health regulatory board to serve individuals admitted to the service.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1690 Substance abuse partial hospitalization services Level of care 2.5 program criteria

A substance abuse partial hospitalization program shall meet the following programmatic requirements. The program shall:

1. Offer no fewer than 20 hours of skilled treatment services per week in a structured program. Services may include individual and group counseling, medication management, family therapy, peer recovery support services, educational groups, or occupational and recreational therapy;

2. Provide a combination of individual and group therapy as deemed appropriate by a licensed professional and included in an assessment and treatment plan;

3. Provide medical and nursing services as deemed appropriate by a licensed professional and included in an assessment and treatment plan;

4. Provide motivational enhancement and engagement strategies appropriate to an individual's stage of readiness to change and level of comprehension;

5. Have direct affiliations with other easily accessible levels of care or coordinate through referral to more or less intensive levels of care and other services;

6. Provide family and caregiver treatment services as deemed appropriate by a licensed professional and included in an assessment and treatment plan;

7. Provide educational and informational programming adaptable to individual needs;

8. Ensure and document that the length of service shall be determined by the individual's condition and functioning;

9. Make emergency services available by telephone 24 hours a day, seven days a week when the program is not in session; and

10. Make MAT available for all individuals with opioid use disorder or alcohol use disorder. MAT may be provided by facility staff or coordinated through alternative resources.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1700 Substance abuse partial hospitalization Level of care 2.5 admission criteria

Before a substance abuse partial hospitalization program may admit an individual, the individual shall meet the criteria for admission as defined by the provider's policies. The provider's policy regarding admission shall at a minimum require the individual to:

1. Meet diagnostic criteria for a substance use disorder or addictive disorder as defined by the DSM; and

2. Meet the admission criteria of Level 2.5 of ASAM, including the specific criteria for adult and adolescent populations.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1710 Substance abuse partial hospitalization Level of care 2.5 discharge criteria

Before a substance abuse partial hospitalization program may discharge or transfer an individual, the individual shall meet the criteria for discharge or transfer as defined by the provider's policies, which shall include provisions for the discharge or transfer of individuals who have:

1. Achieved the goals of the treatment services and no longer require ASAM 2.5 level of care;

2. Been unable to achieve the goals of the individual's treatment but could achieve the individual's goals with a different type of treatment; or

3. Achieved the individual's original treatment goals but have developed new treatment challenges that can only be adequately addressed in a different type of treatment.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1720 Substance abuse partial hospitalization Level of care 2.5 co-occurring enhanced programs

A. Substance abuse partial hospitalization co-occurring enhanced programs shall offer psychiatric services appropriate to the individual's mental health condition. Such services shall be available by telephone and onsite or closely coordinated offsite, within a shorter time than in a co-occurring capable program.

B. Substance abuse partial hospitalization co-occurring enhanced programs shall be staffed by appropriately credentialed mental health professionals who assess and treat co-occurring mental disorders. Intensive case management shall be delivered by cross-trained, interdisciplinary staff through mobile outreach and shall involve engagement-oriented addiction treatment and psychiatric programming. All clinical staff shall be qualified by training and experience and appropriately licensed, certified, or registered by the appropriate health regulatory board to serve individuals admitted to the service.

C. Substance abuse partial hospitalization co-occurring enhanced programs shall offer intensive case management, assertive community treatment, medication management, and psychotherapy.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

Article 7 Intensive Outpatient Services Level of care 2.1

12VAC35-105-1730 Substance abuse intensive outpatient services Level of care 2.1 staff criteria

A substance abuse intensive outpatient services program shall meet the following staff requirements. The program shall:

1. Be staffed by interdisciplinary team of appropriately credentialed addiction treatment professionals, which may include counselors, psychologists, social workers, and addiction-credentialed physicians. Physicians shall have specialty training or experience in addiction medicine or addiction psychiatry;

2. Have program staff that are able to obtain and interpret information regarding the individual's biopsychosocial needs;

3. Have program staff trained to understand the signs and symptoms of mental disorders and to understand and be able to explain the uses of psychotropic medications and their interactions with substance use and other addictive disorders; and

4. Ensure all clinical staff are qualified by training and experience and appropriately licensed, certified, or registered by the appropriate health regulatory board to serve individuals admitted to the service.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1740 Substance abuse intensive outpatient services Level of care 2.1 program criteria

A substance abuse intensive outpatient services program shall meet the following programmatic requirements. The program shall:

1. Offer a minimum of three service hours per service day to achieve no fewer than nine hours and no more than 19 hours of programming per week in a structured environment;

2. Ensure psychiatric and other medical consultation shall be available within 24 hours by telephone and within 72 hours in person;

3. Offer consultation in case of emergency related to an individual's substance use disorder by telephone 24 hours a day, seven days a week when the treatment program is not in session;

4. Provide a combination of individual and group therapy as deemed appropriate by a licensed professional and included in an assessment and treatment plan;

5. Have direct affiliations with other easily accessible levels of care or coordinate through referral to more or less intensive levels of care and other services;

6. Provide family and caregiver treatment and peer recovery support services as deemed appropriate by a licensed professional and included in an assessment and treatment plan;

7. Provide education and informational programming adaptable to individual needs and developmental status;

8. Ensure and document that the length of service shall be determined by the individual's condition and functioning; and

9. Make MAT available for all individuals with opioid use disorder and alcohol use disorder. MAT may be provided by facility staff or coordinated through alternative resources.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1750 Substance abuse intensive outpatient services Level of care 2.1 admission criteria

Before a substance abuse intensive outpatient services program may admit an individual, the individual shall meet the criteria for admission as defined by the provider's policies. The provider's policy regarding admission shall at a minimum require the individual to:

1. Meet diagnostic criteria for a substance use disorder or addictive disorder as defined by the DSM; and

2. Meet the admission criteria of Level 2.1 of ASAM, including the specific criteria for adult and adolescent populations.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1760 Substance abuse intensive outpatient services Level of care 2.1 discharge criteria

Before a substance abuse intensive outpatient services program may discharge or transfer an individual, the individual shall meet the criteria for discharge or transfer as defined by the provider's policies, which shall include provisions for the discharge or transfer of individuals who have:

1. Achieved the goals of the treatment services and no longer require ASAM 2.1 level of care;

2. Been unable to achieve the goals of the individual's treatment but could achieve the individual's goals with a different type of treatment; or

3. Achieved the individual's original treatment goals but have developed new treatment challenges that can only be adequately addressed in a different type of treatment.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1770 Substance abuse intensive outpatient services Level of care 2.1 co-occurring enhanced programs

A. Substance abuse intensive outpatient services co-occurring enhanced programs shall offer psychiatric services appropriate to the individual's mental health condition. Such services shall be available by telephone and onsite or closely coordinated offsite, within a shorter time than in a co-occurring capable program.

B. Substance abuse intensive outpatient services co-occurring enhanced programs shall be staffed by appropriately credential mental health professionals who assess and treat co-occurring mental disorders. Capacity to consult with an addiction psychiatrist shall be available. All clinical staff shall be qualified by training and experience and appropriately licensed, certified, or registered by the appropriate health regulatory board to serve individuals admitted to the service.

C. Substance abuse intensive outpatient services co-occurring enhanced programs shall offer intensive case management, assertive community treatment, medication management, and psychotherapy.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

Article 8 Substance Abuse Outpatient Services Level of care 1.0

12VAC35-105-1780 Substance abuse outpatient services Level of care 1.0 staff criteria

Substance abuse outpatient services programs shall meet the following staff requirements. The program shall:

1. Have appropriately credentialed or licensed treatment professionals who assess and treat substance-related mental and addictive disorders;

2. Have program staff who are capable of monitoring stabilized mental health problems and recognizing any instability of individuals with co-occurring mental health conditions;

3. Provide medication management services by a licensed independent practitioner with prescribing authority; and

4. Ensure all clinical staff are qualified by training and experience and appropriately licensed, certified, or registered by the appropriate health regulatory board to serve individuals admitted to the service.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1790 Substance abuse outpatient services Level of care 1.0 program criteria

Substance abuse outpatient services programs shall meet the following programmatic requirements. The program shall:

1. Offer no more than nine hours of programming a week;

2. Ensure emergency services shall be available by telephone 24 hours a day, seven days a week;

3. Provide individual or group counseling, motivational enhancement, family therapy, educational groups, occupational and recreational therapy, psychotherapy, addiction, and pharmacotherapy as indicated by each individual's needs;

4. For individuals with mental illness, ensure the use of psychotropic medication, mental health treatment and that the individual's relationship to substance abuse disorders shall be addressed as the need arises;

5. Provide medical, psychiatric, psychological, laboratory, and toxicology services onsite or through consultation or referral. Medical and psychiatric consultation shall be available within 24 hours by telephone, or if in person, within a timeframe appropriate to the severity and urgency of the consultation requested;

6. Have direct affiliations with other easily accessible levels of care or coordinate through referral to more or less intensive levels of care and other services; and

7. Ensure through documentation that the duration of treatment varies with the severity of the individual's illness and response to treatment.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1800 Substance abuse outpatient services Level of care 1.0 admission criteria

Before a substance abuse outpatient services program may admit an individual, the individual shall meet the criteria for admission as defined by the provider's policies. The provider's policy regarding admission shall at a minimum require the individual to:

1. Meet diagnostic criteria for a substance use disorder or addictive disorder as defined by the DSM; and

2. Meet the admission criteria of Level 1.0 of ASAM, including the specific criteria for adult and adolescent populations.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1810 Substance abuse outpatient services Level of care 1.0 discharge criteria

Before a substance abuse outpatient services program may discharge or transfer an individual, the individual shall meet the criteria for discharge or transfer as defined by the provider's policies, which shall include provisions for the discharge or transfer of individuals who have:

1. Achieved the goals of the treatment services and no longer require ASAM 1.0 level of care;

2. Been unable to achieve the goals of the individual's treatment but could achieve the individual's goals with a different type of treatment; or

3. Achieved the individual's original treatment goals but have developed new treatment challenges that can only be adequately addressed in a different type of treatment.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1820 Substance abuse outpatient services Level of care 1.0 co-occurring enhanced programs

A. Substance abuse outpatient services co-occurring enhanced programs shall offer ongoing intensive case management for highly crisis-prone individuals with co-occurring disorders.

B. Substance abuse outpatient services co-occurring enhanced programs shall include credentialed mental health trained personnel who are able to assess, monitor, and manage the types of severe and chronic mental disorders seen in a level 1 setting as well as other psychiatric disorders that are mildly unstable. Staff shall be knowledgeable about management of co-occurring mental and substance-related disorders, including assessment of the individual's stage of readiness to change and engagement of individuals who have co-occurring mental disorders. All clinical staff shall be qualified by training and experience and appropriately licensed, certified, or registered by the appropriate health regulatory board to serve individuals admitted to the service.

C. Substance abuse outpatient services co-occurring enhanced programs shall offer therapies to actively address, monitor, and manage psychotropic medication, mental health treatment, and interaction with substance-related and addictive disorders.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

Article 9 Mobile Medication-Assisted Treatment Services

12VAC35-105-1821 Application for operation of a mobile medication-assisted treatment program

Each mobile medication-assisted treatment program shall operate as a component of a licensed MAT location and shall be listed on the provider's license addendum.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. December 5, 2024; Errata, 41:6 VA.R. 756 November 4, 2024.

12VAC35-105-1822 Physical security controls; mobile MAT programs; storage areas

A. For any conveyance operated as a mobile MAT program, a safe must be installed and used to store narcotic drugs in Schedules II through V for the purpose of maintenance or detoxification treatment, when not located at the provider's U.S. Drug Enforcement Administration (DEA) registered location. The safe shall:

1. Have the following specifications or the equivalent: 30 man-minutes against surreptitious entry, 10 man-minutes against forced entry, 20 man-hours against lock manipulation, and 20 man-hours against radiological techniques;

2. If it weighs less than 750 pounds, be bolted or cemented to the floor or wall in such a way that it cannot be readily removed; and

3. Be equipped with an alarm system that, upon attempted unauthorized entry, shall transmit a signal directly to a central protection company or a local or state police agency that has a legal duty to respond or a 24-hour control station operated by the DEA registrant.

B. The controlled substance storage areas shall be accessible only to an absolute minimum number of specifically authorized employees. When it is necessary for employee maintenance personnel, nonemployee maintenance personnel, business guests, or visitors to be present in or pass through controlled substance storage areas, the registrant shall provide for adequate observation of the area by an employee specifically authorized in writing.

C. The storage area for controlled substances in a mobile MAT program shall not be accessible from outside of the vehicle.

D. Personnel transporting the controlled substances on behalf of the mobile MAT program are required to retain control over all controlled substances when transferring the controlled substances between the DEA registered location and the conveyance, while en route to and from the dispensing locations, and when dispensing at the dispensing location. At all other times during transportation, all controlled substances shall be properly secured in the safe.

E. Upon completion of the operation of the mobile MAT program on a given day, the conveyance shall be immediately returned to the DEA registered location, and all controlled substances shall be removed from the conveyance and secured within the DEA registered location. After the conveyance has returned to the DEA registered location and the controlled substances have been removed, the conveyance may be parked until its next use at the DEA registered location or in any secure, fenced-in area once the local DEA office has been notified of the location of the secure, fenced-in area.

F. All mobile MAT programs shall establish a standard written operating procedure to ensure, if the mobile MAT program becomes inoperable, that all controlled substances on the inoperable conveyance are accounted for, removed from the inoperable conveyance, and secured at the DEA registered location.

G. With regard to the requirement within subsection E of this section, a mobile MAT program may apply to the DEA for an exception to this requirement. The application for such an exception must be submitted to the DEA in accordance with 21 CFR 1307.03. If the DEA grants an exception, the provider shall be permitted to operate in accordance with that exception. The provider shall maintain a record of the exception at the DEA registered location and in the mobile MAT program conveyance.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. December 5, 2024; Errata, 41:6 VA.R. 756 November 4, 2024.

12VAC35-105-1824 Other security controls for mobile MATs

A. Individuals enrolled in a mobile MAT program shall wait in an area that is physically separated from the narcotic storage and dispensing area by a physical entrance, such as a door or other entryway. Individuals served must wait outside of a mobile MAT program component if that conveyance does not have seating or a reception area that is separated from the narcotic storage and dispensing area. This requirement shall be enforced by the provider and all provider employees.

B. All mobile MAT programs shall comply with standards established by the U.S. Secretary of Health and Human Services respecting the quantities of narcotic drugs that may be provided to persons enrolled in a mobile MAT program for unsupervised use.

C. Provider personnel who are authorized to dispense controlled substances for narcotic treatment shall ensure proper security measures and patient dosage. The mobile MAT program shall comply with U.S. Drug Enforcement Administration (DEA) security requirements.

D. Any controlled substances being transported for disposal from the dispensing location of a mobile MAT program shall be secured and disposed of in compliance with 21 CFR Part 1317 and all other applicable federal, state, tribal, and local laws and regulations.

E. A conveyance used as part of a mobile MAT program may only be supplied with narcotic drugs by the DEA registered MAT that operates the conveyance. No persons permitted to dispense controlled substances to a mobile MAT shall:

1. Receive controlled substances from other mobile MAT programs or any other entity;

2. Deliver controlled substances to other mobile MAT programs or any other entity; or

3. Conduct reverse distribution of controlled substances on a mobile MAT program.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. December 5, 2024; Errata, 41:6 VA.R. 756 November 4, 2024.

12VAC35-105-1826 Records for mobile MATs

A. A provider of a mobile MAT program shall maintain records with the following information for each narcotic controlled substance:

1. Name of substance;

2. Strength of substance;

3. Dosage form;

4. Date dispensed;

5. Adequate identification of individuals served;

6. Amount consumed;

7. Amount and dosage form taken home by individuals served; and

8. Dispenser's initials.

B. The records required by subsection A of this section shall be maintained in a dispensing log at the U.S. Drug Enforcement Administration (DEA) registered site of the mobile MAT program and shall be maintained in compliance with 21 CFR 1304.22 without reference to 21 CFR 1304.03.

C. As an alternative to maintaining a paper dispensing log, a mobile MAT program may also use an automated or computerized data processing system for the storage and retrieval of program dispensing records if the following conditions are met:

1. The automated system maintains the information required in subsection A of this section;

2. The automated system has the capability of producing a hard copy printout of the program's dispensing records;

3. The mobile MAT program prints a hard copy of each day's dispensing log, which is then initialed appropriately by each person who dispensed medication to individuals served;

4. The automated system is approved by DEA;

5. The mobile MAT program maintains an offsite back-up of all computer-generated program information; and

6. The automated system is capable of producing accurate summary reports for both the DEA registered site of the mobile MAT program and any mobile MAT program for any timeframe selected by department personnel during an investigation. If these summary reports are maintained in hard copy form, they must be kept in a systematically organized file located at the DEA registered site of the mobile MAT program.

D. The provider shall retain all records for a minimum of six years following the last patient encounter in accordance with § 54.1-2910.4 of the Code of Virginia.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. December 5, 2024; Errata, 41:6 VA.R. 756 November 4, 2024.

12VAC35-105-1828 Physical plant exemption for mobile MATs

Mobile MAT program locations are exempt from physical plant requirements located within 12VAC35-105-260 through 12VAC35-105-380.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 41, Issue 5, eff. December 5, 2024; Errata, 41:6 VA.R. 756 November 4, 2024.

Part VIII Crisis Services

12VAC35-105-1830 Applicability of part

All crisis receiving centers, community-based crisis stabilization, crisis stabilization units, and REACH providers shall comply with the provisions of this part.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 40, Issue 22, eff. July 17, 2024.

12VAC35-105-1840 Staffing

A. Crisis receiving centers shall meet the following staffing requirements:

1. A licensed psychiatrist or nurse practitioner shall be available to the program, either in person or via telemedicine, 24 hours per day, seven days per week;

2. An LMHP, LMHP-R, LMHP-RP, or LMHP-S shall be available for conducting assessments;

3. Nursing services shall be provided by a registered nurse (RN) or a licensed practical nurse (LPN). Nursing staff shall be available 24 hours per day, in person. LPNs shall work directly under the supervision of a physician, nurse practitioner, or RN; and

4. Medical, psychological, psychiatric, laboratory, and toxicology services shall be available by consult or referral.

B. Community-based crisis stabilization shall meet the following staffing requirements:

1. An LMHP, LMHP-R, LMHP-RP, or LMHP-S shall conduct assessments and, for any CEPP not authored by an LMHP, review, and if the LMHP, LMHP-R, LMHP-RP, or LMHP-S agrees, sign the CEPP;

2. All staff are required to utilize a working global positioning system (GPS) enabled smart phone or GPS-enabled tablet;

3. Any time staff are dispatched for the provision of mobile crisis response, the provider shall dispatch a team that meets at least one of the following staffing composition requirements:

a. If a single person is dispatched for mobile crisis response:

(1) One licensed staff member; or

(2) One certified pre-screener.

b. If the provider dispatches a team for mobile crisis, the team shall include:

(1) One licensed staff member and one peer recovery specialist (PRS);

(2) One licensed staff member and one certified substance abuse counselor (CSAC), CSAC-supervisee, or certified substance abuse counselor assistant (CSAC-A);

(3) One licensed staff member and one QMHP or QMHP-T;

(4) One PRS and either one QMHP or one CSAC or CSAC-supervisee. A licensed staff member shall be required to be available via telemedicine for the assessment;

(5) One CSAC-A and either one QMHP or one CSAC or CSAC-supervisee. A licensed staff member shall be required to be available via telemedicine for the assessment;

(6) Two QMHPs or one QMHP and one QMHP-T. A licensed staff member shall be required to be available via telemedicine for the assessment;

(7) Two CSACs. A licensed staff member shall be required to be available via telemedicine for the assessment; or

(8) One QMHP and one CSAC or CSAC-supervisee. A licensed staff member shall be required to be available via telemedicine for the assessment.

C. Crisis stabilization units shall meet the following staffing requirements:

1. A licensed psychiatrist or psychiatric nurse practitioner shall be available 24 hours per day, seven days per week either in person or via telemedicine;

2. An LMHP, LMHP-R, LMHP-RP, or LMHP-S shall be available to conduct an assessment;

3. Nursing services shall be provided by either an RN or an LPN. Nursing staff shall be available in person 24 hours per day, seven days per week. LPNs shall work directly under the supervision of a physician, nurse practitioner, or an RN; and

4. Medical, psychological, psychiatric, laboratory, and toxicology services shall be available by consult or referral.

D. REACH shall meet the staffing standards specific to its licensed services. The service shall also meet the REACH standards. A REACH crisis therapeutic home shall meet both the crisis stabilization unit standards and the REACH standards.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 40, Issue 22, eff. July 17, 2024; amended, Virginia Register Volume 41, Issue 20, eff. June 18, 2025.

12VAC35-105-1850 Crisis assessment

A. The provider shall implement a written crisis assessment policy. The policy shall define how crisis assessments will be conducted and documented.

B. The provider shall actively involve the individual and the individual's authorized representative, if applicable, in the preparation of crisis assessment. In the crisis assessment, the provider shall consider the individual's needs, strengths, goals, preferences, and abilities within the individual's cultural context.

C. The crisis assessment policy shall designate appropriately qualified employees or contractors who are responsible for conducting, obtaining, or updating assessments and medical screenings. These employees or contractors shall have experience working with the needs of individuals who are being assessed, with the crisis assessment tools being utilized and with the provision of services that the individuals may require. The crisis assessment policy shall include methods the provider will utilize to identify other appropriate services to assist individuals who are not admitted to the provider's service.

D. Assessment is an ongoing activity. The provider shall make reasonable attempts to obtain previous assessments or history relevant to the crisis. The provider shall use the individual's previous assessments or other relevant history within the course of treatment, if applicable, as noted within subsection F of this section.

E. Providers shall utilize standardized state-sanctioned or federally sanctioned crisis assessment tools as approved by the department or utilize their own crisis assessment tools that shall meet the requirements in subsection F of this section.

F. A crisis assessment shall be initiated prior to or at admission to the service. With the participation of the individual and the individual's authorized representative, if applicable, the provider shall complete or obtain information from other qualified providers in order to complete a crisis assessment detailed enough to (i) determine whether the individual qualifies for admission and (ii) initiate a safety plan or crisis ISP as required by this chapter for those individuals who are admitted to the service. The crisis assessment shall assess the individual's service, health, and safety needs and, at a minimum, include:

1. For community-based crisis stabilization providers providing the mobile crisis component of the service and crisis receiving centers:

a. Diagnosis, including current and past substance use or dependence and risk for intoxication or substance withdrawal, and co-occurring mental illness or developmental disability;

b. Risk of harm, including elements that may make an individual a danger to self or others;

c. Cognitive functional status, including the individual's ability to protect from self-harm and provide for the individual’s basic human needs;

d. Precipitating issues, including recent stressors or events;

e. Presenting needs, including the individual's stated needs, psychiatric needs, support needs, and the onset and duration of needs. The assessor shall record:

(1) Any physical reaction to the presenting crisis if these issues are mentioned by the individual or observed during the assessment. Examples include issues with sleep, appetite, or daily activities;

(2) The individual's housing arrangements and living situation if mentioned by the individual; and

(3) Any trauma, such as sexual abuse, physical abuse, or natural disaster, if appropriate, including if a trauma is related to the current crisis or mentioned by the individual;

f. Additional current medical issues and symptoms, if applicable;

g. Current medications, including recent changes to medications. The assessor shall review current medications to the best of the individual's ability;

h. Barriers that will impact the individual's ability to seek treatment or continue to participate in services, including the individual's mood, ability, and willingness to engage in treatment, and access to transportation;

i. The individual's recovery environment and circle of support; and

j. Communication modality and language preference.

2. For crisis stabilization units and community-based crisis stabilization providing services other than mobile crisis, the assessment shall also include:

a. Relevant treatment history and health history, to include as applicable:

(1) Past prescribed medications;

(2) Hospitalizations for challenging behaviors, mental illness, or substance use;

(3) Other treatments for challenging behaviors, mental illness, or substance use;

(4) Allergies, including allergies to food and medications;

(5) Recent physical complaints and medical conditions;

(6) Nutritional needs;

(7) Chronic conditions;

(8) Communicable diseases;

(9) Restrictions on physical activities, if any;

(10) Restrictive protocols or special supervision requirements;

(11) Preferred interventions in the event behaviors or symptoms become a danger to self or others;

(12) All known contraindications to the use of seclusion, time out, or any form of physical or mechanical restraint, including medical contraindications and history of trauma;

(13) Past serious illnesses, serious injuries, and hospitalizations;

(14) Serious illnesses and chronic conditions of the individual's parents, siblings, and significant others in the same household; and

(15) Other interventions and outcomes, including interventions and outcomes that were unsuccessful. The provider should ensure previous assessments are utilized to note these interventions.

b. The individual's housing arrangements or living situation;

c. Trauma, such as sexual abuse, physical abuse, or natural disaster; and

d. Current or previous involvement in systems, such as legal, adult protective services, or child protective services.

3. If applicable to the individual's crisis, the assessment shall include:

a. The individual’s social, behavioral, developmental, and family history and supports;

b. Employment, vocational, and educational background;

c. Cultural and heritage considerations; and

d. Financial stressors, if applicable.

G. The timing for completion of the crisis assessment shall be as soon as possible after admission but no later than 24 hours after admission.

H. The provider shall retain documentation of the assessments in the individual's record for a minimum of six years following the last patient encounter, in accordance with § 54.1-2910.4 of the Code of Virginia.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 40, Issue 22, eff. July 17, 2024.

12VAC35-105-1860 Safety plans and crisis individualized services plans

A. The provider shall actively involve the individual and the individual's authorized representative, as appropriate, in the development, review, and revision of a person-centered safety plan and, if appropriate, crisis individualized services plan (crisis ISP). The individualized safety and services planning process shall be consistent with laws protecting confidentiality, privacy, human rights of individuals receiving services, and rights of minors. To the extent possible, the provider shall collaborate with the individual's crisis planning team to develop, review, revise, and implement, as appropriate, the individual's safety plan or crisis ISP.

B. Providers of developmental services shall collaborate with the individual’s support coordinator to develop or review, revise, and implement, as appropriate, a person-centered CEPP. A provisional CEPP shall be completed within 15 days of admission. An updated CEPP shall be completed within 45 days of admission. Developmental services providers may utilize a CEPP as an individual's safety plan, if appropriate. If a CEPP is to be used as a safety plan, the provider shall meet the deadline listed in subsection C of this section.

C. Providers of mental health and substance abuse services shall develop or review, revise, and implement, as appropriate, a person-centered safety plan immediately after admission that shall continue in effect until discharge from the provider’s crisis service.

D. Providers of crisis services shall develop or review, revise, and implement a crisis ISP as soon as possible after admission but no later than 48 hours after admission and prior to discharge from the provider's crisis service. This provision does not apply to the initial mobile crisis contact or to crisis receiving centers.

E. The safety plan and crisis ISP shall be developed based on the crisis assessment with the participation and informed choice of the individual receiving services.

1. To ensure the individual's participation and informed choice, the following shall be explained to the individual or the individual's authorized representative, as applicable, in a reasonable and comprehensible manner:

a. The proposed services to be delivered;

b. Any alternative services that might be advantageous for the individual; and

c. Any accompanying risks or benefits of the proposed alternative services.

2. If no alternative services are available to the individual, it shall be documented within the individual's service record that alternative services were not available and any steps taken to identify if alternative services were available.

3. Whenever there is a change to an individual's safety plan or crisis ISP, the changes shall be documented within the safety plan or crisis ISP or within documentation attached to the safety plan or crisis ISP that:

a. The individual participated in the development of or revision to the safety plan or crisis ISP;

b. The proposed and alternative services and the respective risks and benefits of those services were explained to the individual or the individual's authorized representative; and

c. The reasons the individual or the individual's authorized representative chose the option included in the safety plan or crisis ISP.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 40, Issue 22, eff. July 17, 2024.

12VAC35-105-1870 Safety plan and crisis ISP requirements

A. All individuals receiving crisis services shall have a safety plan.

1. The safety plan shall be based on the individual's immediate service, health, and safety needs identified in the crisis assessment. The safety planning process shall be an ongoing activity. The safety plan shall include:

a. Warning signs that a crisis may be developing, such as thoughts, images, mood, situation, and behavior or stressors that may trigger the individual;

b. Internal coping strategies and things the individual can do without contacting another person, such as relaxation techniques or physical activities;

c. People and social settings that the individual may turn to for distraction or support;

d. People the individual may ask for help;

e. Professionals or agencies the individual can contact during a crisis; and

f. Things the individual can do to make the individual's environment safe.

2. The safety plan may include:

a. A description of how to support the individual when pre-crisis behaviors are observed;

b. Specific instructions for the systems supporting the individual when pre-crisis behaviors are observed;

c. A description of how to support the individual when crisis behaviors are observed; and

d. Specific instructions for the systems supporting the individual during crisis.

3. In the event an individual receiving services requires medication management or seclusion, the need shall be clearly documented in an attachment to the individual's safety plan.

B. Community-based crisis stabilization and crisis stabilization unit providers shall also develop a crisis ISP. A crisis ISP shall be based on the individual's immediate service, health, and safety needs identified in the crisis assessment. The crisis ISP shall include:

1. Relevant and attainable goals, measurable objectives to inform current and future treatment, and specific strategies for addressing each need documented within the individual's crisis assessment;

2. Services, supports, and frequency of services required to accomplish the goals, including relevant psychological, mental health, substance use, behavioral, medical, rehabilitation, training, and nursing needs and supports;

3. Any use of seclusion if allowed in the service per 12VAC35-115;

4.The role of the individual and others, including the individual's family, if appropriate, in implementing the crisis ISP;

5. Identification of employees or contractors responsible for the coordination and integration of services, including employees of other agencies;

6. A behavioral support or treatment plan, if applicable; and

7. Projected discharge plan and estimated length of stay within the service.

C. In order to document agreement, both the safety plan and the crisis ISP shall be signed and dated, at a minimum, by the person responsible for implementing the safety plan or crisis ISP and the individual receiving services or the individual's authorized representative, if appropriate.

1. If the signature of the individual receiving services or the individual's authorized representative cannot be obtained, the provider shall document attempts to obtain the necessary signature and the reason why obtaining it was not possible. The provider shall continue to make attempts to obtain the necessary signature for the length of time the safety plan or crisis ISP is in effect. An attempt to obtain the necessary signature shall occur, at a minimum, each time the provider reviews the safety plan or crisis ISP.

2. The safety plan and crisis ISP shall be distributed to the individual and others authorized to receive it. The provider shall document that the safety plan and crisis ISP were distributed within the individual's service record. If the safety plan or crisis ISP cannot be distributed, the provider shall document attempts to distribute the safety plan and crisis ISP to the individual and the reason why distribution was not possible. The provider shall continue to make attempts to distribute the safety plan and crisis ISP for the length of time the safety plan and crisis ISP are in effect. An attempt to distribute the safety plan and crisis ISP shall occur, at a minimum, each time the provider reviews the safety plan or crisis ISP.

D. The provider shall have a safety plan and crisis ISP policy that designates a staff person responsible for developing, implementing, reviewing, and revising each individual's safety plan and crisis ISP, in collaboration with the individual or the individual's authorized representative, as appropriate.

E. Employees or contractors who are responsible for implementing the safety plan or crisis ISP shall (i) have access to the individual's safety plan or crisis ISP, including an individual's detailed health and safety protocols; and (ii) be competent to implement the safety plan or crisis ISP as written.

F. Whenever possible, the identified goals in the safety plan or crisis ISP shall be written in the words of the individual receiving services.

G. The provider shall use signed and dated progress notes to document the provider's efforts toward the implementation of the goals and objectives contained within the safety plan or crisis ISP.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 40, Issue 22, eff. July 17, 2024.

12VAC35-105-1880 Crisis discharge planning

A. Crisis providers are not subject to the provisions of 12VAC35-105-693.

B. Community-based crisis stabilization providers of mobile crisis response and crisis receiving center providers shall make referrals to all follow-up service providers if determined appropriate and document in accordance with the provider's crisis assessment policy. The provider shall document such arrangements, referrals, or reasons why follow-up care was not indicated within the individual's record.

C. Community-based crisis stabilization providers, when providing mobile crisis response services, and crisis receiving centers providers are not required to provide discharge planning to individuals receiving services and, therefore, are not subject to subsections D through H of this section.

D. Community-based crisis stabilization providers, crisis stabilization units, and REACH providers shall have written policies and procedures regarding the discharge or termination of individuals from the service. These policies and procedures shall include medical and clinical criteria for discharge.

E. Discharge instructions shall be provided in writing to the individual, the individual's authorized representative, and any successor provider, as applicable. Discharge instructions shall include, at a minimum, medications and dosages; names, telephone numbers, and addresses of any providers to whom the individual is referred; current medical issues or conditions; and the identity of the treating health care providers. The provider shall make appropriate referrals to all service providers identified within the individual's discharge instructions prior to the individual's scheduled discharge date.

F. The provider shall document in the individual's service record whether the individual, the individual's authorized representative, and the individual's family members, as appropriate, were involved in the discharge planning process.

G. A written discharge summary shall be completed within 30 days of discharge and shall include, at a minimum, the following:

1. The reason for the individual's admission to and discharge from the service;

2. A description of the individual's and the individual's authorized representative's participation in discharge planning and documentation of informed choice by the individual, the individual's authorized representative, or the individual's legal guardian, as applicable, in the decision to and planning for discharge;

3. The individual's current level of functioning or functioning limitations, if applicable;

4. Recommended procedures, activities, or referrals to assist the individual in maintaining or improving functioning and increased independence;

5. The status, location, and arrangements that were made for future services;

6. Progress made by the individual in achieving goals and objectives identified in the crisis ISP and summary of critical events during service provision;

7. Discharge date;

8. Any discharge medications prescribed by the provider, if applicable;

9. Dates the discharge plan was written and documented; and

10. The signature of the person who prepared the discharge plan.

H. The content of the discharge summary and the determination to discharge the individual shall be consistent with the crisis ISP and the criteria for discharge.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 40, Issue 22, eff. July 17, 2024.

12VAC35-105-1890 Nursing assessment

A. Crisis receiving centers, crisis stabilization units, and REACH CTH providers shall administer a nursing assessment within 24 hours of admission of an individual.

B. Prior to admission, each individual shall have a screening for communicable diseases, including tuberculosis, as evidenced by the completion of a screening form containing, at a minimum, the elements found on the Report of Tuberculosis Screening form published by the Virginia Department of Health. The screening shall be no older than 30 days. No screening shall be required for a new individual separated from a service with another licensed provider with a break in service of six months or less or who is transferred from another department-licensed provider.

C. A staff member shall conduct a nursing assessment. The nursing assessment shall collect information about the nonpsychiatric medical or surgical condition of an individual to determine whether there is a need for a medical assessment before a decision is made regarding continued treatment within the provider's service or transfer to a more intensive level of care. The nursing assessment shall determine if there is a current medical crisis or underlying medical condition for the individual's psychological crisis, such as any medical condition that affects the individual's psychological state, presenting behavior, or ability to receive the provider's service. The nursing assessment shall note the date of examination and have the signature of a qualified practitioner.

D. Locations designated for nursing assessments shall ensure individual privacy.

E. The provider shall review and follow up with (i) the results of the nursing assessment, including any follow-up diagnostic tests, treatments, or examinations, and (ii) documentation of the arrangements for follow-up care in the individual's record.

F. Each individual's health record shall include notations of any health or dental complaints mentioned by the individual or any injuries and shall summarize symptoms and treatment given.

G. Each individual's health record shall include or document the facility's efforts to obtain treatment summaries of ongoing psychiatric or other mental health treatment and reports.

H. The provider shall develop and implement written policies and procedures that include the use of standard precautions and address communicable and contagious medical conditions.

I. Community-based crisis stabilization providers are not required to administer nursing assessments. The provider may administer a nursing assessment if the provider has the resources to do so or may obtain a medical history or relevant information that would be a part of a medical history if the individual receiving services provides it.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 40, Issue 22, eff. July 17, 2024.

12VAC35-105-1900 Vital signs for crisis services

A. This section applies to all crisis receiving centers, crisis stabilization units, and REACH CTH providers.

B. Unless the individual refuses, the provider shall take vital signs upon admission, during the provision of services as per the medical provider's orders, and at discharge.

C. The provider shall implement written procedures regarding the collection of vital signs, including documentation of vital signs, all refusals, and all follow-up actions taken.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 40, Issue 22, eff. July 17, 2024.

12VAC35-105-1910 Beds or recliners for crisis services

A. For the purpose of this section, "clean" means freshly laundered, sanitized, and not soiled or stained.

B. Crisis receiving center providers shall arrange for each individual to have a recliner or bed. Crisis stabilization unit and REACH CTH providers shall arrange for each individual to have a bed.

C. Upon admission, the provider shall offer to launder the individual's clothes.

D. The provider shall not operate more recliners or beds at each service location than the number for which its service is licensed at that location.

E. Recliners, beds, and linens shall be clean, comfortable, and well-maintained.

F. Beds shall be equipped with a clean mattress, and recliners shall be equipped with clean cushions. Beds and recliners shall be equipped with a clean pillow, clean blankets, and clean linens. When a bed or recliner is soiled, providers shall assist individuals with bathing, as needed, and provide clean clothing and clean linens, including a clean waterproof mattress cover for a bed.

G. Providers shall change linens at least every seven days and with each new admission.

H. Providers shall provide mattresses that are fire retardant as evidenced by documentation from the manufacturer, except in buildings equipped with an automated sprinkler system as required by the Virginia Uniform Statewide Building Code (13VAC5-63).

I. Providers shall inspect each individual's recliner or bed upon discharge to (i) ensure the individual has all personal belongings and (ii) prepare the recliner or bed for cleaning.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 40, Issue 22, eff. July 17, 2024.

12VAC35-105-1920 Bedrooms for crisis services

A. This section only applies to crisis stabilization units and REACH CTH providers.

B. Bedrooms shall meet the following square footage requirements:

1. Single occupancy bedrooms shall have no less than 80 square feet of floor space.

2. Multiple occupancy bedrooms shall have no less than 60 square feet of floor space per individual.

C. No more than four individuals shall share a bedroom.

D. Bedrooms shall be free of all protrusions, sharp corners, hardware, fixtures, or other devices that may cause injury to the individual.

E. Windows in the bedrooms shall be so constructed as to minimize breakage and otherwise prevent the individual from self-harming.

F. Each individual shall have adequate private storage space accessible to the bedroom for clothing and personal belongings.

G. Each sleeping area shall have a door that can be (i) closed for privacy or quiet and (ii) readily opened in case of fire or other emergency.

H. The environment of sleeping areas shall be conducive to sleep and rest.

I. Providers of children's residential services shall provide separate sleeping areas for boys and girls four years of age or older.

J. Providers of children's residential services shall ensure beds are at least three feet apart at the head, foot, and sides, and double-decker beds shall be at least five feet apart at the head, foot, and sides.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 40, Issue 22, eff. July 17, 2024.

12VAC35-105-1930 Physical environment for crisis services

A. The physical environment, design, structure, furnishings, and lighting shall be appropriate to the individuals receiving services and the services provided.

B. The physical environment shall be accessible to individuals with physical and sensory disabilities.

C. The physical environment and furnishings shall be clean, dry, free of foul odors, safe, and well-maintained.

D. Floor surfaces and floor coverings shall promote mobility in areas used by individuals and shall promote maintenance of sanitary conditions. There shall be clear pathways through the setting, free of tripping hazards, to ensure that all individuals can move about the setting safely.

Any electrical cords, extension cords, or power strips utilized by the provider shall be properly secured and shall not be placed anywhere that the cord or strip can cause trips or falls.

E. Heat shall be evenly distributed in all rooms occupied by individuals such that a temperature no less than 68°F is maintained, unless otherwise mandated by state or federal authorities. Natural or mechanical ventilation to the outside shall be provided in all rooms used by residents. Individual or mechanical ventilating systems shall be provided in all rooms occupied by individuals when the temperature in those rooms exceeds 80°F.

F. Plumbing shall be maintained in good operational condition. Adequate hot and cold running water of a safe and appropriate temperature shall be available. Hot water accessible to individuals receiving services shall be maintained within a range of 100° to 120°F. Precautions shall be taken to prevent scalding from running water.

G. Adequate provision shall be made for the collection and legal disposal of garbage and waste materials.

H. The physical environment, structure, furnishings, and lighting shall be kept free of vermin, rodents, insects, and other pests.

I. If smoking is permitted, the provider shall make provisions for alternate smoking areas that are separate from the service environment.

J. For all program areas added after September 19, 2002, minimum room height shall be 7-1/2 feet.

K. Bedroom, bathroom, and dressing area windows and doors shall provide privacy.

L. Bathrooms intended for use by more than one individual at the same time shall provide privacy for showers and toilets.

M. The right of privacy within bathrooms includes the right to be free of cameras or audio monitors within the bathroom or angled toward a bathroom.

N. Bedrooms and bathrooms shall be free of all protrusions, sharp corners, hardware, fixtures, or other devices that may cause injury to the individual. Windows in the bathrooms shall be so constructed as to minimize breakage and otherwise prevent the individual from self-harming.

O. No required path of travel to the bathroom shall be through another bedroom. Each individual's room shall have direct access to a corridor, living area, dining area, or other common area.

P. Each provider shall make available at least one toilet, one hand basin, and a shower or bath for every four individuals. Providers of children's residential services shall:

1. Make available at least one toilet, one hand basin, and one shower or bathtub in each living unit;

2. Make available at least one bathroom equipped with a bathtub in each facility;

3. Make available at least one toilet, one hand basin, and one shower or bathtub for every eight individuals for facilities licensed before July 1, 1981;

4. Make available one toilet, one hand basin, and one shower or bathtub for every four individuals in any building constructed or structurally modified after July 1, 1981. Facilities licensed after December 28, 2007, shall comply with the one-to-four ratio; and

5. The maximum number of staff members on duty in the living unit shall be counted in determining the required number of toilets and hand basins when a separate bathroom is not provided for staff.

Q. If a provider utilizes cameras or audio monitors, the provider shall have written policies and procedures regarding audio or audio-video recordings of individuals receiving services approved by the Office of Licensing and the Office of Human Rights. The policies and procedures shall ensure and provide that:

1. The provider has obtained written consent of the individual before the individual is recorded;

2. No recording by the provider shall take place without the individual being informed;

3. The provider has postings informing individuals receiving services and others that recording is taking place; and

4. All recordings shall be used in a manner that respects the dignity and confidentiality of the individuals receiving services.

R. A provider shall develop and implement written policies and procedures approved by the Office of Licensing governing searches that shall provide that:

1. Searches shall be limited to instances where they are necessary to prohibit contraband;

2. Searches shall be conducted only by personnel who are specifically authorized to conduct searches by the written policies and procedures;

3. Searches shall be conducted in such a way to protect the individual's dignity and in the presence of one or more witnesses; and

4. The policies and procedures shall note the actions to be taken by a provider if contraband is found by a search, including methods to manage and dispose of contraband.

S. Providers who serve temporary detention orders or emergency custody orders shall ensure the program is provided in a secure facility or a secure program space.

T. Providers shall provide privacy from routine sight supervision by staff members while bathing, dressing, or conducting toileting activities. This subsection does not apply to medical personnel performing medical procedures or staff providing assistance to individuals whose physical, mental, or safety needs dictate the need for assistance with these activities as justified in the individual's record.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 40, Issue 22, eff. July 17, 2024.

12VAC35-105-1940 Seclusion

Seclusion is only allowed as permitted by 12VAC35-115 and other applicable state regulations.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 40, Issue 22, eff. July 17, 2024.

12VAC35-105-1950 Seclusion room requirements

The room used for seclusion of persons shall meet the following design requirements:

1. The seclusion room shall be at least six feet wide and six feet long with a minimum ceiling height of eight feet.

2. The seclusion room shall be free of all protrusions, sharp corners, hardware, fixtures, or other devices that may cause injury to the occupant.

3. Windows in the seclusion room shall be constructed to minimize breakage and otherwise prevent the occupant from self-harming.

4. Light fixtures and other electrical receptacles in the seclusion room shall be recessed or so constructed as to prevent the occupant from self-harming. Light controls shall be located outside the seclusion room.

5. Doors to the seclusion room shall be at least 32 inches wide, open outward, and shall contain observation view panels of transparent wire glass or its approved equivalent, not exceeding 120 square inches but of sufficient size for someone outside the door to see into all corners of the room.

6. The seclusion room shall contain only a mattress with a washable mattress covering designed to avoid damage by tearing.

7. The seclusion room shall maintain temperatures appropriate for the season.

8. All space in the seclusion room shall be visible through the locked door, either directly or by mirrors.

History

• Statutory Authority: §§ 37.2-302 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 40, Issue 22, eff. July 17, 2024.

Chapter 115 Regulations to Assure the Rights of Individuals Receiving Services from Providers Licensed, Funded, or Operated by the Department of Behavioral Health and Developmental Services

Part I General Provisions

12VAC35-115-10 Authority and applicability

A. The Code of Virginia authorizes these regulations to further define and protect the rights of individuals receiving services from providers of mental health, developmental, or substance abuse services in Virginia. This chapter requires providers of services to take specific actions to protect the rights of each individual. This chapter establishes remedies when rights are violated or are in dispute and provides a structure for support of these rights.

B. Providers subject to this chapter include:

1. Facilities operated by the department under Chapters 3 (§ 37.2-300 et seq.) and 7 (§ 37.2-700 et seq.) of Title 37.2 of the Code of Virginia;

2. Sexually violent predator programs established under § 37.2-909 of the Code of Virginia;

3. Community services boards that provide services under Chapter 5 (§ 37.2-500 et seq.) of Title 37.2 of the Code of Virginia;

4. Behavioral health authorities that provide services under Chapter 6 (§ 37.2-600 et seq.) of Title 37.2 of the Code of Virginia;

5. Public or private providers that operate programs or facilities licensed by the department under Article 2 (§ 37.2-403 et seq.) of Chapter 4 of Title 37.2 of the Code of Virginia except those operated by the Department of Corrections; and

6. Any other providers receiving funding from the department. Providers of services under Part C of the Individuals with Disabilities Education Act (IDEA), 20 USC §§ 1431-1444, that are subject to this chapter solely by receipt of Part C funds from or through the department shall comply with all applicable IDEA regulations found in 34 CFR Part 303 in lieu of this chapter.

C. Unless otherwise provided by law, this chapter applies to all individuals who are receiving services from a public or private provider of services operated, licensed, or funded by the Department of Behavioral Health and Developmental Services, except those operated by the Department of Corrections.

D. This chapter applies to individuals under forensic status and individuals committed to the custody of the department as sexually violent predators, except to the extent that the commissioner may determine this chapter is not applicable to them. The exemption shall be in writing and based solely on the need to protect individuals receiving services, employees, or the general public. The commissioner shall give the State Human Rights Committee (SHRC) chairperson prior notice of all exemptions and provide the written exemption to the SHRC for its information. These exemptions shall be time limited and services shall not be compromised.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007; Errata, 24:2 VA.R. 255 October 1, 2007; amended, Virginia Register Volume 29, Issue 4, eff. November 21, 2012; Volume 33, Issue 10, eff. February 9, 2017.

12VAC35-115-20 Policy

A. Each individual who receives services shall be assured:

1. Protection to exercise his legal, civil, and human rights related to the receipt of those services;

2. Respect for basic human dignity; and

3. Services that are provided consistent with sound therapeutic practice.

B. Providers shall not deny any individual his legal rights solely because he has been voluntarily or involuntarily admitted, certified for admission or committed to services. These legal rights include the right to:

1. Acquire, retain, and dispose of property;

2. Sign legal documents;

3. Buy or sell;

4. Enter into contracts;

5. Register and vote;

6. Get married, separated, divorced, or have a marriage annulled;

7. Hold a professional, occupational, or vehicle operator's license;

8. Make a will and execute an advance directive; and

9. Have access to lawyers and the courts.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007.

12VAC35-115-30 Definitions

The following words and terms when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise:

"Abuse" means any act or failure to act by an employee or other person responsible for the care of an individual in a facility or program operated, licensed, or funded by the department, excluding those operated by the Department of Corrections, that was performed or was failed to be performed knowingly, recklessly, or intentionally, and that caused or might have caused physical or psychological harm, injury, or death to a person receiving care or treatment for mental illness, intellectual disability, or substance abuse. Examples of abuse include acts such as:

1. Rape, sexual assault, or other criminal sexual behavior;

2. Assault or battery;

3. Use of language that demeans, threatens, intimidates, or humiliates the person;

4. Misuse or misappropriation of the person's assets, goods, or property;

5. Use of excessive force when placing a person in physical or mechanical restraint;

6. Use of physical or mechanical restraints on a person that is not in compliance with federal and state laws, regulations, and policies; professionally accepted standards of practice; or the person's individualized services plan; and

7. Use of more restrictive or intensive services or denial of services to punish the person or that is not consistent with his individualized services plan. See § 37.2-100 of the Code of Virginia.

"Administrative hearing" means an administrative proceeding held pursuant to Chapter 40 (§ 2.2-4000 et seq.) of Title 2.2 of the Code of Virginia.

"Advance directive" means a document voluntarily executed in accordance with § 54.1-2983 of the Code of Virginia or the laws of another state where executed (§ 54.1-2993 of the Code of Virginia). This may include a wellness recovery action plan (WRAP) or similar document as long as it is executed in accordance with § 54.1-2983 of the Code of Virginia or the laws of another state. A WRAP or similar document may identify the health care agent who is authorized to act as the individual's substitute decision maker.

"Authorization" means a document signed by the individual receiving services or that individual's authorized representative that authorizes the provider to disclose identifying information about the individual. An authorization shall be voluntary. To be voluntary, the authorization shall be given by the individual receiving services or his authorized representative freely and without undue inducement; any element of force, fraud, deceit, or duress; or any form of constraint or coercion.

"Authorized representative" means a person permitted by law or this chapter to authorize the disclosure of information or to consent to treatment and services or participation in human research. The decision-making authority of an authorized representative recognized or designated under this chapter is limited to decisions pertaining to the designating provider. Legal guardians, attorneys-in-fact, or health care agents appointed pursuant to § 54.1-2983 of the Code of Virginia may have decision-making authority beyond such provider.

"Behavior intervention" means those principles and methods employed by a provider to help an individual to achieve a positive outcome and to address challenging behavior in a constructive and safe manner. Behavior management principles and methods must be employed in accordance with the individualized services plan and written policies and procedures governing service expectations, treatment goals, safety, and security.

"Behavioral treatment plan," "functional plan," or "behavioral support plan" means any set of documented procedures that are an integral part of the individualized services plan and are developed on the basis of a systematic data collection, such as a functional assessment, for the purpose of assisting an individual to achieve the following:

1. Improved behavioral functioning and effectiveness;

2. Alleviation of symptoms of psychopathology; or

3. Reduction of challenging behaviors.

"Board" means the Board of Behavioral Health and Developmental Services.

"Caregiver" means an employee or contractor who provides care and support services; medical services; or other treatment, rehabilitation, or habilitation services.

"Commissioner" means the Commissioner of the Department of Behavioral Health and Developmental Services.

"Community services board" or "CSB" means the public body established pursuant to § 37.2-501 of the Code of Virginia that provides mental health, developmental, and substance abuse services to individuals within each city and county that established it. For the purpose of these regulations, "community services board" also includes a behavioral health authority established pursuant to § 37.2-602 of the Code of Virginia.

"Complaint" means an allegation of a violation of this chapter or a provider's policies and procedures related to this chapter.

"Consent" means the voluntary agreement of an individual or that individual's authorized representative to specific services. Consent shall be given freely and without undue inducement; any element of force, fraud, deceit, or duress; or any form of constraint or coercion. Consent may be expressed through any means appropriate for the individual, including verbally, through physical gestures or behaviors, in Braille or American Sign Language, in writing, or through other methods.

"Department" means the Department of Behavioral Health and Developmental Services.

"Director" means the chief executive officer of any provider delivering services. In organizations that also include services not covered by this chapter, the director is the chief executive officer of the services or services licensed, funded, or operated by the department.

"Discharge plan" means the written plan that establishes the criteria for an individual's discharge from a service and identifies and coordinates delivery of any services needed after discharge.

"Disclosure" means the release by a provider of information identifying an individual.

"Emergency" means a situation that requires a person to take immediate action to avoid harm, injury, or death to an individual or to others.

"Exploitation" means the misuse or misappropriation of the individual's assets, goods, or property. Exploitation is a type of abuse. (See § 37.2-100 of the Code of Virginia.) Exploitation also includes the use of a position of authority to extract personal gain from an individual. Exploitation includes violations of 12VAC35-115-120 and 12VAC35-115-130. Exploitation does not include the billing of an individual's third party payer for services. Exploitation also does not include instances of use or appropriation of an individual's assets, goods, or property when permission is given by the individual or his authorized representative:

1. With full knowledge of the consequences;

2. With no inducements; and

3. Without force, misrepresentation, fraud, deceit, duress of any form, constraint, or coercion.

"Governing body of the provider" means the person or group of persons with final authority to establish policy.

"Habilitation" means the provision of individualized services conforming to current acceptable professional practice that enhance the strengths of, teach functional skills to, or reduce or eliminate challenging behaviors of an individual. These services occur in an environment that suits the individual's needs, responds to his preferences, and promotes social interaction and adaptive behaviors.

"Health care operations" means any activities of the provider to the extent that the activities are related to its provision of health care services. Examples include:

1. Conducting quality assessment and improvement activities, case management and care coordination, contacting of health care providers and patients with information about treatment alternatives, and related functions that do not include treatment;

2. Reviewing the competence or qualifications of health care professionals, evaluating practitioner and provider performance, and training, licensing, or credentialing activities;

3. Conducting or arranging for medical review, legal services, and auditing functions, including fraud and abuse detection and compliance programs; and

4. Other activities contained within the definition of health care operations in 45 CFR 164.501.

"Health plan" means an individual or group plan that provides or pays the cost of medical care, including any entity that meets the definition of "health plan" in 45 CFR 160.103.

"Historical research" means the review of information that identifies individuals receiving services for the purpose of evaluating or otherwise collecting data of general historical significance.

"Human research" means any systematic investigation, including research development, testing, and evaluation, utilizing human subjects that is designed to develop or contribute to generalized knowledge. Human research shall not include research exempt from federal research regulations pursuant to 45 CFR 46.101(b).

"Human rights advocate" means a person employed by the commissioner upon recommendation of the State Human Rights Director to help individuals receiving services exercise their rights under this chapter. See 12VAC35-115-260 C.

"Independent review committee" means a committee appointed or accessed by a provider to review and approve the clinical efficacy of the provider's behavioral treatment plans and associated data collection procedures. An independent review committee shall be composed of professionals with training and experience in behavior analysis and interventions who are not involved in the development of the plan or directly providing services to the individual.

"Individual" means a person who is receiving services. This term includes the terms "consumer," "patient," "resident," "recipient," and "client."

"Individualized services plan" or "ISP" means a comprehensive and regularly updated written plan that describes the individual's needs, the measurable goals and objectives to address those needs, and strategies to reach the individual's goals. An ISP is person-centered, empowers the individual, and is designed to meet the needs and preferences of the individual. The ISP is developed through a partnership between the individual and the provider and includes an individual's treatment plan, habilitation plan, person-centered plan, or plan of care.

"Informed consent" means the voluntary written agreement of an individual, or that individual's authorized representative, to surgery, electroconvulsive treatment, use of psychotropic medications, or any other treatment or service that poses a risk of harm greater than that ordinarily encountered in daily life or for participation in human research. To be voluntary, informed consent must be given freely and without undue inducement; any element of force, fraud, deceit, or duress; or any form of constraint or coercion.

"Investigating authority" means any person or entity that is approved by the provider to conduct investigations of abuse and neglect.

"Licensed professional" means a licensed physician, licensed clinical psychologist, licensed professional counselor, licensed clinical social worker, licensed or certified substance abuse treatment practitioner, or licensed psychiatric nurse practitioner.

"Local human rights committee" or "LHRC" means a group of at least five people appointed by the State Human Rights Committee. See 12VAC35-115-270 A for membership and duties.

"Neglect" means failure by a person, program, or facility operated, licensed, or funded by the department, excluding those operated by the Department of Corrections, responsible for providing services to do so, including nourishment, treatment, care, goods, or services necessary to the health, safety, or welfare of an individual receiving care or treatment for mental illness, intellectual disability, or substance abuse. See § 37.2-100 of the Code of Virginia.

"Next friend" means a person designated in accordance with 12VAC35-115-146 B to serve as the authorized representative of an individual who has been determined to lack capacity to consent or authorize the disclosure of identifying information, when required under this chapter.

"Peer-on-peer aggression" means a physical act, verbal threat, or demeaning expression by an individual against or to another individual that causes physical or emotional harm to that individual. Examples include hitting, kicking, scratching, and other threatening behavior. Such instances may constitute potential neglect.

"Person centered" means focusing on the needs and preferences of the individual, empowering and supporting the individual in defining the direction for his life, and promoting self-determination, community involvement, and recovery.

"Program rules" means the operational rules and expectations that providers establish to promote the general safety and well-being of all individuals in the program and to set standards for how individuals will interact with one another in the program. Program rules include any expectation that produces a consequence for the individual within the program. Program rules may be included in a handbook or policies and shall be available to the individual.

"Protection and advocacy agency" means the state agency designated under the federal Protection and Advocacy for Individuals with Mental Illness Act (PAIMI) and the Developmental Disabilities Assistance and Bill of Rights Act (DD). The protection and advocacy agency is the disAbility Law Center of Virginia (dLCV).

"Provider" means any person, entity, or organization offering services that is licensed, funded, or operated by the department.

"Psychotherapy notes" means comments, recorded in any medium by a health care provider who is a mental health professional, documenting and analyzing the contents of conversation during a private counseling session with an individual or a group, joint, or family counseling session that are separated from the rest of the individual's health record. "Psychotherapy notes" shall not include annotations relating to medication and prescription monitoring, counseling session start and stop times, treatment modalities and frequencies, clinical test results, or any summary of any symptoms, diagnosis, prognosis, functional status, treatment plan, or the individual's progress to date.

"Research review committee" or "institutional review board" means a committee of professionals that provides complete and adequate review of research activities. The committee shall be sufficiently qualified through maturity, experience, and diversity of its members, including consideration of race, gender, and cultural background, to promote respect for its advice and counsel in safeguarding the rights and welfare of participants in human research. (See § 37.2-402 of the Code of Virginia and 12VAC35-180.)

"Restraint" means the use of a mechanical device, medication, physical intervention, or hands-on hold to prevent an individual from moving his body to engage in a behavior that places him or others at imminent risk. There are three kinds of restraints:

1. Mechanical restraint means the use of a mechanical device that cannot be removed by the individual to restrict the freedom of movement or functioning of a limb or a portion of an individual's body when that behavior places him or others at imminent risk.

2. Pharmacological restraint means the use of a medication that is administered involuntarily for the emergency control of an individual's behavior when that individual's behavior places him or others at imminent risk and the administered medication is not a standard treatment for the individual's medical or psychiatric condition.

3. Physical restraint, also referred to as manual hold, means the use of a physical intervention or hands-on hold to prevent an individual from moving his body when that individual's behavior places him or others at imminent risk.

"Restraints for behavioral purposes" means using a physical hold, medication, or a mechanical device to control behavior or involuntarily restrict the freedom of movement of an individual in an instance when all of the following conditions are met: (i) there is an emergency, (ii) nonphysical interventions are not viable, and (iii) safety issues require an immediate response.

"Restraints for medical purposes" means using a physical hold, medication, or mechanical device to limit the mobility of an individual for medical, diagnostic, or surgical purposes, such as routine dental care or radiological procedures and related postprocedure care processes, when use of the restraint is not the accepted clinical practice for treating the individual's condition.

"Restraints for protective purposes" means using a mechanical device to compensate for a physical or cognitive deficit when the individual does not have the option to remove the device. The device may limit an individual's movement, for example, bed rails or a gerichair, and prevent possible harm to the individual or it may create a passive barrier, such as a helmet to protect the individual.

"Restriction" means anything that limits or prevents an individual from freely exercising his rights and privileges.

"SCC" means a specially constituted committee serving an intermediate care facility for individuals with intellectual disabilities as described in the Centers for Medicare and Medicaid Services (CMS) Conditions of Participation (42 CFR 483.440(f)(3)).

"Seclusion" means the involuntary placement of an individual alone in an area secured by a door that is locked or held shut by a staff person, by physically blocking the door, or by any other physical or verbal means, so that the individual cannot leave it.

"Serious injury" means any injury resulting in bodily hurt, damage, harm, or loss that requires medical attention by a licensed physician.

"Services" means care, treatment, training, habilitation, interventions, or other supports, including medical care, delivered by a provider licensed, operated or funded by the department.

"Services record" means all written and electronic information that a provider keeps about an individual who receives services.

"State Human Rights Committee" or "SHRC" means a committee of nine members appointed by the board that is accountable for the duties prescribed in 12VAC35-115-270 C.

"State human rights director" means the person employed by and reporting to the commissioner who is responsible for carrying out the functions prescribed for the position in 12VAC35-115-260 D.

"Time out" means the involuntary removal of an individual by a staff person from a source of reinforcement to a different, open location for a specified period of time or until the problem behavior has subsided to discontinue or reduce the frequency of problematic behavior.

"Treatment" means the individually planned, sound, and therapeutic interventions that are intended to improve or maintain functioning of an individual receiving services delivered by providers licensed, funded, or operated by the department. In order to be considered sound and therapeutic, the treatment shall conform to current acceptable professional practice.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007; Volume 29, Issue 4, eff. November 21, 2012; Volume 33, Issue 10, eff. February 9, 2017; Volume 35, Issue 2, eff. November 1, 2018.

Part II Assurance of Rights

12VAC35-115-40 Assurance of rights

A. These regulations protect the rights established in § 37.2-400 of the Code of Virginia.

B. Individuals are entitled to know what their rights are under these regulations; therefore, providers shall take the following actions:

1. Display, in areas most likely to be noticed by the individual, a document listing the rights of individuals under these regulations and how individuals can contact a human rights advocate. The document shall be presented in the manner, format, and languages most frequently understood by the individual receiving services.

2. Notify each individual and his authorized representative about these rights and how to file a complaint. The notice shall be in writing and in any other form most easily understood by the individual. The notice shall provide the name and phone number of the human rights advocate and give a short description of the human rights advocate's role. The provider shall give this notice to and discuss it with the individual at the time services begin and every year thereafter.

3. Ask the individual or his authorized representative to sign the notice of rights. File the signed notice in the individual's services record. If the individual or his authorized representative cannot or will not sign the notice, the person who gave the notice shall document that fact in the individual's services record.

4. Give a complete copy of these regulations to anyone who asks for one.

5. Display and provide information as requested by the protection and advocacy agency director that informs individuals of their right to contact the protection and advocacy agency.

C. Every individual has a right to seek resolution of his complaint and make a human rights complaint. Any individual or anyone acting on his behalf who thinks that a provider has violated any of his rights under these regulations may make a complaint and get help in making the complaint in accordance with Part V (12VAC35-115-150 et seq.) of this chapter.

D. Other rights and remedies may be available. These regulations shall not prevent any individual from pursuing any other legal right or remedy to which he may be entitled under federal or state law.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007.

Part III Explanation of Individual Rights and Provider Duties

12VAC35-115-50 Dignity

A. Each individual has a right to exercise his legal, civil, and human rights, including constitutional rights, statutory rights, and the rights contained in this chapter, except as specifically limited in this chapter or otherwise by law. Each individual has a right to have services that he receives respond to his needs and preferences and be person-centered. Each individual also has the right to be protected, respected, and supported in exercising these rights. Providers shall not partially or totally take away or limit these rights solely because an individual has a mental health or substance use disorder or an intellectual disability and is receiving services for these conditions or has any physical or sensory condition that may pose a barrier to communication or mobility.

B. In receiving all services, each individual has the right to:

1. Use his preferred or legal name. The use of an individual's preferred name may be limited when a licensed professional makes the determination that the use of the name will result in demonstrable harm or have significant negative impact on the program itself or the individual's treatment, progress, and recovery. The director or his designee shall discuss the issue with the individual and inform the human rights advocate of the reasons for any restriction prior to implementation and the reasons for the restriction shall be documented in the individual's services record. The need for the restriction shall be reviewed by the team every month and documented in the services record.

2. Be protected from harm including abuse, neglect, and exploitation.

3. Have help in learning about, applying for, and fully using any public service or benefit to which he may be entitled. These services and benefits include educational or vocational services, housing assistance, services or benefits under Titles II, XVI, XVIII, and XIX of the Social Security Act, United States Veterans Benefits, and services from legal and advocacy agencies.

4. Have opportunities to communicate in private with lawyers, judges, legislators, clergy, licensed health care practitioners, authorized representatives, advocates, the Office of the State Inspector General (§ 2.2-308 of the Code of Virginia), and employees of the protection and advocacy agency.

5. Be provided with general information about program services, policies, and rules in writing and in the manner, format and language easily understood by the individual.

6. Be afforded the opportunity to have an individual of his choice notified of his general condition, location, and transfer to another facility.

C. In services provided in residential and inpatient settings, each individual has the right to:

1. Have sufficient and suitable clothing for his exclusive use.

2. Receive nutritionally adequate, varied, and appetizing meals that are prepared and served under sanitary conditions, are served at appropriate times and temperatures, and are consistent with any individualized diet program.

3. Live in a humane, safe, sanitary environment that gives each individual, at a minimum:

a. Reasonable privacy and private storage space;

b. An adequate number of private, operating toilets, sinks, showers, and tubs that are designed to accommodate individuals' physical needs;

c. Direct outside air provided by a window that opens or by an air conditioner;

d. Windows or skylights in all major areas used by individuals;

e. Clean air, free of bad odors; and

f. Room temperatures that are comfortable year round and compatible with health requirements.

4. Practice a religion and participate in religious services subject to their availability, provided that such services are not dangerous to the individual or others and do not infringe on the freedom of others.

a. Religious services or practices that present a danger of bodily injury to any individual or interfere with another individual's religious beliefs or practices may be limited. The director or his designee shall discuss the issue with the individual and inform the human rights advocate of the reasons for any restriction prior to implementation. The reasons for the restriction shall be documented in the individual's services record.

b. Participation in religious services or practices may be reasonably limited by the provider in accordance with other general rules limiting privileges or times or places of activities.

5. Have paper, pencil and stamps provided free of charge for at least one letter every day upon request. However, if an individual has funds to buy paper, pencils, and stamps to send a letter every day, the provider does not have to pay for them.

6. Communicate privately with any person by mail and have help in writing or reading mail as needed.

a. An individual's access to mail may be limited only if the provider has reasonable cause to believe that the mail contains illegal material or anything dangerous. If so, the director or his designee may open the mail, but not read it, in the presence of the individual.

b. An individual's ability to communicate by mail may be limited if, in the judgment of a licensed professional, the individual's communication with another person or persons will result in demonstrable harm to the individual's mental health.

c. The director or his designee shall discuss the issue with the individual and inform the human rights advocate of the reasons for any restriction prior to implementation and the reasons for the restriction shall be documented in the individual's services record. The need for the restriction shall be reviewed by the team every month and documented in the services record.

7. Communicate privately with any person by telephone and have help in doing so. Use of the telephone may be limited to certain times and places to make sure that other individuals have equal access to the telephone and that they can eat, sleep, or participate in an activity without being disturbed.

a. An individual's access to the telephone may be limited only if, in the judgment of a licensed professional, communication with another person or persons will result in demonstrable harm to the individual or significantly affect his treatment.

b. The director or his designee shall discuss the issue with the individual and inform the human rights advocate of the reasons for any restriction prior to implementation and the reasons for the restriction shall be documented in the individual's services record. The need for the restriction shall be reviewed by the team every month and documented in the individual's services record.

c. Residential substance abuse services providers that are not inpatient hospital settings or crisis stabilization programs may develop policies and procedures that limit the use of the telephone during the initial phase of treatment when sound therapeutic practice requires restriction, subject to the following conditions:

(1) Prior to implementation and when it proposes any changes or revisions, the provider shall submit policies and procedures, program handbooks, or program rules to the LHRC and the human rights advocate for review and approval.

(2) When an individual applies for admission, the provider shall notify him of these restrictions.

8. Have or refuse visitors.

a. An individual's access to visitors may be limited or supervised only when, in the judgment of a licensed professional, the visits result in demonstrable harm to the individual or significantly affect the individual's treatment or when the visitors are suspected of bringing contraband or threatening harm to the individual in any other way.

b. The director or his designee shall discuss the issue with the individual and inform the human rights advocate of the reasons for any restriction prior to implementation and the restriction shall be documented in the individual's services record. The need for the restriction shall be reviewed by the team every month and documented in the individual's services record.

c. Residential substance abuse service providers that are not inpatient hospital settings or crisis stabilization programs may develop policies and procedures that limit visitors during the initial phase of treatment when sound therapeutic practice requires the restriction, subject to the following conditions:

(1) Prior to implementation and when proposing any changes or revisions, the provider shall submit policies and procedures, program handbooks, or program rules to the LHRC and the human rights advocate for review and approval.

(2) The provider shall notify individuals who apply for admission of these restrictions.

9. Nothing in these provisions shall prohibit a provider from stopping, reporting, or intervening to prevent any criminal act.

D. The provider's duties.

1. Providers shall recognize, respect, support, and protect the dignity rights of each individual at all times. In the case of a minor, providers shall take into consideration the expressed preferences of the minor and the parent or guardian.

2. Providers shall develop, carry out, and regularly monitor policies and procedures that assure the protection of each individual's rights.

3. Providers shall assure the following relative to abuse, neglect, and exploitation:

a. Policies and procedures governing harm, abuse, neglect, and exploitation of individuals receiving their services shall require that, as a condition of employment or volunteering, any employee, volunteer, consultant, or student who knows of or has reason to believe that an individual may have been abused, neglected, or exploited at any location covered by this chapter shall immediately report this information directly to the director.

b. The director shall immediately take necessary steps to protect the individual until an investigation is complete. This may include the following actions:

(1) Direct the employee or employees involved to have no further contact with the individual. In the case of incidents of peer-on-peer aggression, protect the individuals from the aggressor in accordance with sound therapeutic practice and this chapter.

(2) Temporarily reassign or transfer the employee or employees involved to a position that has no direct contact with individuals receiving services.

(3) Temporarily suspend the involved employee or employees pending completion of an investigation.

4. Providers shall afford the individual the opportunity to have an individual of his choice notified of his general condition, location, and transfer to another facility.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007; Volume 29, Issue 4, eff. November 21, 2012; Volume 31, Issue 1, eff. October 8, 2014; Volume 33, Issue 10, eff. February 9, 2017.

12VAC35-115-60 Services

A. Each individual receiving services shall receive those services according to law and sound therapeutic practice.

B. The provider's duties.

1. Providers shall develop, carry out, and regularly monitor policies and procedures prohibiting discrimination in the provision of services. Providers shall comply with all state and federal laws, including any applicable provisions of the Americans with Disabilities Act (42 USC § 12101 et seq.), that prohibit discrimination.

2. Providers shall ensure that all services, including medical services and treatment, are at all times delivered in accordance with sound therapeutic practice. Providers may deny or limit an individual's access to services if sound therapeutic practice requires limiting the service to individuals of the same sex or similar age, disability, or legal status.

3. Providers shall develop and implement policies and procedures that address emergencies. These policies and procedures shall:

a. Identify what caregivers may do to respond to an emergency;

b. Identify qualified clinical staff who are accountable for assessing emergency conditions and determining the appropriate intervention;

c. Require that the director immediately notify the individual's authorized representative and the advocate if an emergency results in harm or injury to any individual; and

d. Require documentation in the individual's services record of all facts and circumstances surrounding the emergency.

4. Providers shall assign a specific person or group of persons to carry out each of the following activities:

a. Medical, mental health, and behavioral screenings and assessments, as applicable, upon admission and during the provision of services;

b. Preparation, implementation, and modifications to an ISP based on ongoing review of the medical, mental, and behavioral needs of the individual;

c. Preparation and implementation of an individual's discharge plan; and

d. Review of every use of seclusion or restraint by a qualified professional who is involved in providing services to the individual.

5. Providers shall not deliver any service to an individual without an ISP that is tailored specifically to the needs and expressed preferences of the individual and, in the case of a minor, the minor and the minor's parent or guardian or other person authorized to consent to treatment pursuant to § 54.1-2969 A of the Code of Virginia. Services provided in response to emergencies or crises shall be deemed part of the ISP and thereafter documented in the ISP.

6. Providers shall write the ISP and discharge plan in clear, understandable language.

7. When preparing or changing an ISP or discharge plan, providers shall ensure that all services received by the individual are integrated. With the individual's or the individual's authorized representative's authorization, providers may involve family members in services and discharge planning. When the individual or his authorized representative requests such involvement, the provider shall take all reasonable steps to do so. In the case of services to minors, the parent or guardian or other person authorized to consent to treatment pursuant to § 54.1-2969 A of the Code of Virginia shall be involved in service and discharge planning.

8. Providers shall ensure that the entries in an individual's services record are at all times authentic, accurate, complete, timely, and pertinent.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007; Volume 33, Issue 10, eff. February 9, 2017.

12VAC35-115-70 Participation in decision making and consent

A. Each individual has a right to participate meaningfully in decisions regarding all aspects of services affecting him. This includes the right to:

1. Consent or not consent to receive or participate in services.

a. The ISP and discharge plan shall incorporate the individual's preferences consistent with his condition and need for service and the provider's ability to address them;

b. The individual's services record shall include evidence that the individual has participated in the development of his ISP and discharge plan, in changes to these plans, and in all other significant aspects of his treatment and services; and

c. The individual's services record shall include the signature or other indication of the individual's or his authorized representative's consent.

2. Give or not give informed consent to receive or participate in treatment or services that pose a risk of harm greater than ordinarily encountered in daily life and to participate in human research except research that is exempt under § 32.1-162.17 of the Code of Virginia. Informed consent is always required for surgical procedures, electroconvulsive treatment, or use of psychotropic medications.

a. To be informed, consent for any treatment or service must be based on disclosure of and understanding by the individual or his authorized representative of the following information:

(1) An explanation of the treatment, service, or research and its purpose;

(2) When proposing human research, the provider shall describe the research and its purpose, explain how the results of the research will be disseminated and how the identity of the individual will be protected, and explain any compensation or medical care that is available if an injury occurs;

(3) A description of any adverse consequences and risks associated with the research, treatment, or service;

(4) A description of any benefits that may be expected from the research, treatment, or service;

(5) A description of any alternative procedures that might be considered, along with their side effects, risks, and benefits;

(6) Notification that the individual is free to refuse or withdraw his consent and to discontinue participation in any treatment, service, or research requiring his consent at any time without fear of reprisal against or prejudice to him; and

(7) A description of the ways in which the individual or his authorized representative can raise concerns and ask questions about the research, treatment, or service to which consent is given.

b. Evidence of informed consent shall be documented in an individual's services record and indicated by the signature of the individual or his authorized representative on a form or the ISP.

c. Informed consent for electroconvulsive treatment requires the following additional components:

(1) Informed consent shall be in writing, documented on a form that shall become part of the individual's services record. This form shall:

(a) Specify the maximum number of treatments to be administered during the series;

(b) Indicate that the individual has been given the opportunity to view an instructional video presentation about the treatment procedures and their potential side effects; and

(c) Be witnessed in writing by a person not involved in the individual's treatment who attests that the individual has been counseled and informed about the treatment procedures and potential side effects of the procedures.

(2) Separate consent, documented on a new consent form, shall be obtained for any treatments exceeding the maximum number of treatments indicated on the initial consent form.

(3) Providers shall inform the individual or his authorized representative that the individual may obtain a second opinion before receiving electroconvulsive treatment and the individual is free to refuse or withdraw his consent and to discontinue participation at any time without fear of reprisal against or prejudice to him. The provider shall document such notification in the individual's services record.

(4) Before initiating electroconvulsive treatment for any individual under age 18 years, two qualified child psychiatrists must concur with the treatment. The psychiatrists must be trained or experienced in treating children or adolescents and not directly involved in treating the individual. Both must examine the individual, consult with the prescribing psychiatrist, and document their concurrence with the treatment in the individual's services record.

3. Have an authorized representative make decisions for him in cases where the individual has been determined to lack the capacity to consent or authorize the disclosure of information.

a. If an individual who has an authorized representative who is not his legal guardian objects to the disclosure of specific information or a specific proposed treatment or service, the director or his designee shall immediately notify the human rights advocate and authorized representative. A petition for LHRC review of the objection may be filed under 12VAC35-115-200.

b. If the authorized representative objects or refuses to consent to a specific proposed treatment or service for which consent is necessary, the provider shall not institute the proposed treatment, except in an emergency in accordance with this section or as otherwise permitted by law.

4. Be accompanied, except during forensic evaluations, by a person or persons whom the individual trusts to support and represent him when he participates in services planning, assessments, evaluations, including discussions and evaluations of the individual's capacity to consent, and discharge planning.

5. Request admission to or discharge from any service at any time.

B. The provider's duties.

1. Providers shall respect, protect, and help develop each individual's ability to participate meaningfully in decisions regarding all aspects of services affecting him. This shall be done by involving the individual, to the extent permitted by his capacity, in decision making regarding all aspects of services.

2. Providers shall ask the individual to express his preferences about decisions regarding all aspects of services that affect him and shall honor these preferences to the extent possible.

3. Providers shall give each individual the opportunity and any help he needs to participate meaningfully in the preparation of his services plan, discharge plan, and changes to these plans, and all other aspects of services he receives. Providers shall document these opportunities in the individual's services record.

4. Providers shall obtain and document in the individual's services record the individual's or his authorized representative's consent for any treatment before it begins. If the individual is a minor in the legal custody of a natural or adoptive parent, the provider shall obtain this consent from at least one parent. The consent of a parent is not needed if a court has ordered or consented to treatment or services pursuant to § 16.1-241 C or D, 16.1-275, or 54.1-2969 A 1 or B of the Code of Virginia, or a local department of social services with custody of the minor has provided consent. Reasonable efforts must be made, however, to notify the parent or legal custodian promptly following the treatment or services. Additionally, a competent minor may independently consent to treatment for sexually transmitted or contagious diseases, family planning or pregnancy, or outpatient services or treatment for mental illness, emotional disturbance, or substance use disorders pursuant to § 54.1-2969 E of the Code of Virginia.

5. Providers may initiate, administer, or undertake a proposed treatment without the consent of the individual or the individual's authorized representative in an emergency. All emergency treatment or services and the facts and circumstances justifying the emergency shall be documented in the individual's services record within 24 hours of the treatment or services.

a. Providers shall immediately notify the authorized representative of the provision of treatment without consent during an emergency.

b. Providers shall continue emergency treatment without consent beyond 24 hours only following a review of the individual's condition and if a new order is issued by a professional who is authorized by law and the provider to order treatment.

c. Providers shall notify the human rights advocate if emergency treatment without consent continues beyond 24 hours.

d. Providers shall develop and integrate treatment strategies into the ISP to address and prevent future emergencies to the extent possible following provision of emergency treatment without consent.

6. Providers shall obtain and document in the individual's services record the consent of the individual or his authorized representative to continue any treatment initiated in an emergency that lasts longer than 24 hours after the emergency began.

7. Providers may provide treatment in accordance with a court order or in accordance with other provisions of law that authorize such treatment or services including § 54.1-2970 of the Code of Virginia and the Health Care Decisions Act (§ 54.1-2981 et seq. of the Code of Virginia). The provisions of these regulations are not intended to be exclusive of other provisions of law but are cumulative.

8. Providers shall respond to an individual's request for discharge set forth in statute and shall make sure that the individual is not subject to punishment, reprisal, or reduction in services because he makes a request. However, if an individual leaves a service against medical advice, any subsequent billing of the individual by his private third party payer shall not constitute punishment or reprisal on the part of the provider.

a. Voluntary admissions.

(1) Individuals admitted under § 37.2-805 of the Code of Virginia to state hospitals operated by the department who notify the director of their intent to leave shall be discharged when appropriate, but no later than eight hours after notification, unless another provision of law authorizes the director to retain the individual for a longer period.

(2) Minors admitted under § 16.1-338 or 16.1-339 of the Code of Virginia shall be released to the parent's or legal guardian's custody within 48 hours of the consenting parent's or legal guardian's notification of withdrawal of consent, unless a petition for continued hospitalization pursuant to § 16.1-340.1 or 16.1-341 of the Code of Virginia is filed.

b. Involuntary admissions.

(1) When a minor involuntarily admitted under § 16.1-345 of the Code of Virginia no longer meets the commitment criteria, the director shall take appropriate steps to arrange the minor's discharge.

(2) When an individual involuntarily admitted under § 37.2-817 of the Code of Virginia has been receiving services for more than 30 days and makes a written request for discharge, the director shall determine whether the individual continues to meet the criteria for involuntary admission. If the director denies the request for discharge, he shall notify the individual in writing of the reasons for denial and of the individual's right to seek relief in the courts. The request and the reasons for denial shall be included in the individual's services record. Anytime the individual meets any of the criteria for discharge set out in § 37.2-837 or 37.2-838 of the Code of Virginia, the director shall take all necessary steps to arrange the individual's discharge.

(3) If at any time it is determined that an individual involuntarily admitted under Chapter 11 (§ 19.2-167 et seq.) or Chapter 11.1 (§ 19.2-182.2 et seq.) of Title 19.2 of the Code of Virginia no longer meets the criteria under which the individual was admitted and retained, the director or commissioner, as appropriate, shall seek judicial authorization to discharge or transfer the individual. Further, pursuant to § 19.2-182.6 of the Code of Virginia, the commissioner shall petition the committing court for conditional or unconditional release at any time he believes the acquittee no longer needs hospitalization.

c. Certified admissions. If an individual certified for admission to a state training center or his authorized representative requests discharge, the director or his designee shall contact the individual's community services board to finalize and implement the discharge plan.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007; Volume 31, Issue 1, eff. October 8, 2014.

12VAC35-115-80 Confidentiality

A. Each individual is entitled to have all identifying information that a provider maintains or knows about him remain confidential. Each individual has a right to give his authorization before the provider shares identifying information about him or his care unless another state law or regulation, or these regulations specifically require or permit the provider to disclose certain specific information.

B. The provider's duties.

1. Providers shall maintain the confidentiality of any information that identifies an individual. If an individual's services record pertains in whole or in part to referral, diagnosis or treatment of substance use disorders, providers shall disclose information only according to applicable federal regulations (see 42 CFR Part 2, Confidentiality of Alcohol and Drug Abuse Patient Records).

2. Providers shall obtain and document in the individual's services record the individual's authorization or that of the authorized representative prior to disclosing any identifying information about him. The authorization must contain the following elements:

a. The name of the organization and the name or other specific identification of the person or persons or class of persons to whom disclosure is made;

b. A description of the nature of the information to be disclosed, the purpose of the disclosure, and an indication whether the authorization extends to the information placed in the individual's record after the authorization was given but before it expires;

c. An indication of the effective date of the authorization and the date the authorization will expire, or the event or condition upon which it will expire; and

d. The signature of the individual and the date. If the authorization is signed by an authorized representative, a description of the authorized representative's authority to act.

3. Providers shall tell each individual and his authorized representative about the individual's confidentiality rights. This shall include how information can be disclosed and how others might get information about the individual without his authorization. If a disclosure is not required by law, the provider shall give strong consideration to any objections from the individual or his authorized representative in making the decision to disclose information.

4. Providers shall prevent unauthorized disclosures of information from services records and shall maintain and disclose information in a secure manner.

5. In the case of a minor, the authorization of the custodial parent or other person authorized to consent to the minor's treatment under § 54.1-2969 is required, except as provided below:

a. Section 54.1-2969 E of the Code of Virginia permits a minor to authorize the disclosure of information related to medical or health services for a sexually transmitted or contagious disease, family planning or pregnancy, and outpatient care, treatment or rehabilitation for substance use disorders, mental illness, or emotional disturbance.

b. The concurrent authorization of the minor and custodial parent is required to disclose inpatient substance abuse records.

c. The minor and the custodial parent shall authorize the disclosure of identifying information related to the minor's inpatient psychiatric hospitalization when the minor is 14 years of age or older and has consented to the admission.

6. When providers disclose identifying information, they shall attach a statement that informs the person receiving the information that it must not be disclosed to anyone else unless the individual authorizes the disclosure or unless state law or regulation allows or requires further disclosure without authorization.

7. Providers may encourage individuals to name family members, friends, and others who may be told of their presence in the program and general condition or well-being. Except for information governed by 42 CFR Part 2, providers may disclose to a family member, other relative, a close personal friend, or any other person identified by the individual, information that is directly relevant to that persons involvement with the individual's care or payment for his health care, if (i) the provider obtains the individual's agreement, (ii) the provider provides the individual with the opportunity to object to the disclosure, and (iii) the individual does not object or the provider reasonably infers for the circumstances, based or the exercise of professional judgment, that the individual does not object to the disclosure. If the opportunity to agree or object cannot be provided because of the individual's incapacity or an emergency circumstance, the provider may, in the exercise of professional judgment, determine whether the disclosure is in the best interest of the individual and, if so, disclose only the information that is directly relevant to the person's involvement with the individual's health care.

8. Providers may disclose the following identifying information without authorization or violation of the individual's confidentiality, but only under the conditions specified in the following subdivisions of this subsection. Providers should always consult 42 CFR Part 2, Confidentiality of Alcohol and Drug Abuse Patient Records, if applicable, because these federal regulations may prohibit some of the disclosures addressed in this section.

a. Emergencies: Providers may disclose information in an emergency to any person who needs that particular information for the purpose of preventing injury to or death of an individual or other person. The provider shall not disclose any information that is not needed for this specific purpose.

b. Providers or health plans: Providers may permit any full-time or part-time employee, consultant, agent, or contractor of the provider to use identifying information or disclose to another provider, a health plan, the department, or a CSB, information required to give services to the individual or to get payment for the services.

c. Court proceedings: If the individual or someone acting for him introduces any aspect of his mental condition or services as an issue before a court, administrative agency, or medical malpractice review panel, the provider may disclose any information relevant to that issue. The provider may also disclose any records if they are properly subpoenaed, if a court orders them to be produced, or if involuntary admission or certification for admission is being proposed.

d. Legal counsel: Providers may disclose information to their own legal counsel or to anyone working on behalf of their legal counsel in providing representation to the provider. Providers of state-operated services may disclose information to the Office of the Attorney General or to anyone appointed by or working on behalf of that office in providing representation to the Commonwealth of Virginia.

e. Human rights committees: Providers may disclose to the LHRC and the SHRC any information necessary for the conduct of their responsibilities under these regulations.

f. Others authorized or required by the commissioner, CSB, or private program director: Providers may disclose information to other persons if authorized or required for the following activities:

(1) Licensing, human rights, or certification or accreditation reviews;

(2) Hearings, reviews, appeals, or investigations under these regulations;

(3) Evaluation of provider performance and individual outcomes (see §§ 37.2-508 and 37.2-608 of the Code of Virginia);

(4) Statistical reporting;

(5) Preauthorization, utilization reviews, financial and related administrative services reviews, and audits; or

(6) Similar oversight and review activities.

g. Preadmission screening, services, and discharge planning: Providers may disclose to the department, the CSB, or to other providers information necessary to screen individuals for admission or to prepare and carry out a comprehensive individualized services or discharge plan (see § 37.2-505 of the Code of Virginia).

h. Protection and advocacy agency: Providers may disclose information to the protection and advocacy agency in accordance with that agency's legal authority under federal and state law.

i. Historical research: Providers may disclose information to persons engaging in bona fide historical research if all of the following conditions are met:

(1) The request for historical research shall include, at a minimum, a summary of the scope and purpose of the research, a description of the product to result from the research and its expected date of completion, a rationale explaining the need to access otherwise private information, and the specific identification of the type and location of the records sought;

(2) The commissioner, CSB executive director, or private program director has authorized the research;

(3) The individual or individuals who are the subject of the disclosure are deceased;

(4) There are no known living persons permitted by law to authorize the disclosure; and

(5) The disclosure would in no way reveal the identity of any person who is not the subject of the historical research.

j. Protection of public safety: If an individual receiving services makes a specific threat to cause serious bodily injury or death to an identified or readily identifiable person and the provider reasonably believes that the individual has the intent and the ability to carry out the threat immediately or imminently, the provider may disclose those facts necessary to alleviate the potential threat.

k. Inspector General: Providers may disclose to the Office of the State Inspector General (§ 2.2-308 of the Code of Virginia) any individual services records and other information relevant to the provider's delivery of services.

l. Virginia Patient Level Data System: Providers may disclose financial and services information to Virginia Health Information as required by law (see Chapter 7.2 (§ 32.1-276.2 et seq.) of Title 32.1 of the Code of Virginia).

m. Psychotherapy notes: Providers shall obtain an individual's authorization for any disclosure of psychotherapy notes, except when disclosure is made:

(1) For the provider's own training programs in which students, trainees, or practitioners in mental health are being taught under supervision to practice or improve their skills in group, joint, family or individual counseling;

(2) To defend the provider or its employees or staff against any accusation or wrongful conduct;

(3) In discharge of the provider's duty, in accordance with § 54.1-2400.1 B of the Code of Virginia, to take precautions to protect third parties from violent behavior or other serious harm;

(4) As required in the course of an investigation, audit, review, or proceeding regarding a provider's conduct by a duly authorized law enforcement, licensure, accreditation, or professional review entity; or

(5) When otherwise required by law.

n. A law-enforcement official:

(1) Pursuant to a search warrant or grand jury subpoena;

(2) In response to their request, for the purpose of identifying or locating a suspect, fugitive, an individual required to register pursuant to § 9.1-901 of the Sex Offender and Crimes Against Minors Registry Act, material witness, or missing person, provided that only the following information is disclosed:

(a) Name and address of the individual;

(b) Date and place of birth of the individual;

(c) Social security number of the individual;

(d) Blood type of the individual;

(e) Date and time of treatment received by the individual;

(f) Date and time of death of the individual;

(g) Description of distinguishing physical characteristics of the individual; and

(h) Type of injury sustained by the individual;

(3) Regarding the death of an individual for the purpose of alerting law enforcement of the death if the health care entity has a suspicion that such death may have resulted from criminal conduct; or

(4) If the health care entity believes in good faith that the information disclosed constitutes evidence of a crime that occurred on its premises.

o. Other statutes or regulations: Providers may disclose information to the extent required or permitted by any other state or law or regulation. See also § 32.1-127.1:03 of the Code of Virginia for a list of circumstances in which records may be disclosed without authorization.

9. Upon request, the provider shall tell the individual or his authorized representative the sources of information contained in his services records and provide a written listing of disclosures of information made without authorization, except for disclosures:

a. To employees of the department, CSB, the provider, or other providers;

b. To carry out treatment, payment, or health care operations;

c. That are incidental or unintentional disclosures that occur as a by-product of engaging in health care communications and practices that are already permitted or required;

d. To an individual or his authorized representative;

e. Pursuant to an authorization;

f. For national security or intelligence purposes;

g. To correctional institutions or law-enforcement officials; or

h. That were made more than six years prior to the request.

10. The provider shall include the following information in the listing of disclosures of information provided to the individual or his authorized representative under subdivision 9 of this subsection:

a. The name of the person or organization that received the information and the address if known;

b. A brief description of the information disclosed; and

c. A brief statement of the purpose of the disclosure or, in lieu of such a statement, a copy of the written request for disclosure.

11. If the provider makes multiple disclosures of information to the same person or entity for a single purpose, the provider shall include the following:

a. The information required in subdivision 10 of this subsection for the first disclosure made during the requested period;

b. The frequency, periodicity, or number of disclosures made during the period for which the individual is requesting information; and

c. The date of the last disclosure during the time period.

12. If the provider makes a disclosure to a social service or protective services agency about an individual who the provider reasonably believes to be a victim of abuse or neglect, the provider is not required to inform the individual or his authorized representative of the disclosure if:

a. The provider, in the exercise of professional judgment, believes that informing the individual would place the individual at risk of serious harm; or

b. The provider would be informing the authorized representative, and the provider reasonably believes that the authorized representative is responsible for the abuse or neglect, and that informing such person would not be in the best interests of the individual.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007; Volume 29, Issue 4, eff. November 21, 2012; Volume 31, Issue 1, eff. October 8, 2014.

12VAC35-115-90 Access to and amendment of services records

A. With respect to his own services record, each individual and his authorized representative has the right to:

1. See, read, and get a copy of his own services record, except information that is privileged pursuant to § 8.01-581.17 of the Code of Virginia, and information compiled by the provider in reasonable anticipation of or for use in a civil, criminal, or administrative action or proceeding;

2. Let certain other people see, read, or get a copy of his own services record if the individual is restricted by law from seeing, reading, or receiving a copy;

3. Challenge, request to amend, or receive an explanation of anything in his services record; and

4. Let anyone who sees his record, regardless of whether amendments to the record have been made, know that the individual has tried to amend the record or explain his position and what happened as a result.

B. With respect to the services records of minors:

1. A minor must have the permission of a parent, guardian, or other person standing in loco parentis before he can access his services record. He may access his services record without this permission only if the records pertain to treatment for sexually transmitted or reportable contagious diseases, family planning or pregnancy, outpatient care, treatment or rehabilitation for substance use disorders, mental illness or emotional disturbance, or inpatient psychiatric hospitalization when a minor is 14 years of age or older and has consented to the admission.

2. A parent may access his minor child's services record unless prohibited by 42 CFR Part 2, parental rights have been terminated, a court order provides otherwise, or the minor's treating physician or clinical psychologist has determined, in the exercise of professional judgment, that disclosure to the parent would be reasonably likely to cause substantial harm to the minor or another person.

C. The provider's duties.

1. Providers shall tell each individual and his authorized representative how he can access and request amendment of his own services record.

2. Providers shall permit each individual to see his services record when he requests it and to request amendments if necessary.

a. Access to all or a part of an individual's services record may be denied or limited only if a physician or a clinical psychologist involved in providing services to the individual talks to the individual, examines the services record as a result of the individual's request for access, and signs and puts in the services record permanently a written statement that he thinks access to the services record by the individual at this time would be reasonably likely to endanger the life or physical safety of the individual or another person or that the services record makes reference to a person other than a health care provider and the access requested would be reasonably likely to cause substantial harm to the referenced person. The physician or clinical psychologist shall also tell the individual as much about his services record as he can without risking harm to the individual.

b. If access is denied in whole or in part, the provider shall give the individual or his authorized representative a written statement that explains the basis for the denial, the individual's review rights, as set forth in the following subdivisions, how he may exercise them, and how the individual may file a complaint with the provider or the U.S. Department of Health and Human Services, if applicable. If restrictions are placed on access, the individual shall be notified of the restrictions and conditions for their removal. These restrictions and conditions also shall be specified in the services record.

(1) If the individual requests a review of denial of access, the provider shall designate a physician or clinical psychologist who was not directly involved in the denial to review the decision to deny access. The physician or clinical psychologist shall determine within a reasonable period of time whether or not to deny the access requested in accordance with the standard in subdivision 2 a of this subsection. The provider shall promptly provide the individual notice of the physician's or psychologist's determination and provide or deny access in accordance with that determination.

(2) At the individual's option, the individual may designate at his own expense a reviewing physician or clinical psychologist who was not directly involved in the denial to review the decision to deny access in accordance with the standard in subdivision 2 a of this subsection. If the individual chooses this option, the provider is not required to designate a physician or clinical psychologist to review the decision.

c. If the provider limits or refuses to let an individual see his services record, the provider shall also notify the advocate and tell the individual that he can ask to have a lawyer or authorized insurer of his choice see his record. If the individual makes this request, the provider shall disclose the record to that lawyer or authorized insurer (§ 8.01-413 of the Code of Virginia).

3. Providers shall, without charge, give individuals any help they may need to read and understand their services record and request amendments to it.

4. If an individual asks to challenge, amend, or explain any information contained in his services record, the provider shall investigate and file in the services record a written report concerning the individual's request.

a. If the report finds that the services record is incomplete, inaccurate, not pertinent, not timely, or not necessary, the provider shall:

(1) Either mark that part of the services record clearly to say so, or else remove that part of the services record and file it separately with an appropriate cross reference to indicate that the information was removed;

(2) Not disclose the original services record without separate specific authorization or legal authority (e.g., if compelled by subpoena or other court order);

(3) Obtain the individual's identification of and agreement to have the provider notify the relevant persons of the amendment; and

(4) Promptly notify in writing all persons who have received the incorrect information and all persons identified by the individual that the services record has been corrected.

b. If a request to amend the services record is denied, the provider shall give the individual a written statement containing the basis for the denial and notify the individual of his right to submit a statement of disagreement and how to submit such a statement. The provider shall also give the individual (i) a statement that if a statement of disagreement is not submitted that the individual may request the provider to disclose the request for amendment and the denial with future disclosures of information and (ii) a description of how the individual may complain to the provider or the Secretary of Health and Human Services, if applicable. Upon request, the provider shall file in the services record the individual's statement of disagreement. If needed, the provider shall help the individual to write this statement. If a statement is filed, the provider shall:

(1) Give all persons who have copies of the record a copy of the individual's statement.

(2) Clearly note in any later disclosure of the record that it is disputed and include a copy of the statement with the disputed record.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007; Errata, 24:6 VA.R. 889 November 26, 2007; amended, Virginia Register Volume 33, Issue 10, eff. February 9, 2017.

12VAC35-115-100 Restrictions on freedoms of everyday life

A. From admission until discharge from a service, each individual is entitled to:

1. Enjoy all the freedoms of everyday life that are consistent with his need for services, his protection, and the protection of others, and that do not interfere with his services or the services of others. These freedoms include:

a. Freedom to move within the service setting, its grounds, and the community;

b. Freedom to communicate, associate, and meet privately with anyone the individual chooses;

c. Freedom to have and spend personal money;

d. Freedom to see, hear, or receive television, radio, books, and newspapers, whether privately owned or in a library or public area of the service setting;

e. Freedom to keep and use personal clothing and other personal items;

f. Freedom to use recreational facilities and enjoy the outdoors; and

g. Freedom to make purchases in canteens, vending machines, or stores selling a basic selection of food and clothing.

2. Receive services in that setting and under those conditions that are least restrictive of his freedom.

B. The provider's duties.

1. Providers shall encourage each individual's participation in normal activities and conditions of everyday living and support each individual's freedoms.

2. Providers shall not limit or restrict any individual's freedom more than is needed to achieve a therapeutic benefit, maintain a safe and orderly environment, or intervene in an emergency.

3. Providers shall not impose any restriction on an individual unless the restriction is justified and carried out according to this chapter or otherwise required by law. If a provider imposes a restriction pursuant to this chapter, except as provided in 12VAC35-115-50, the following conditions shall be met:

a. A qualified professional involved in providing services has, in advance, assessed and documented all possible alternatives to the proposed restriction, taking into account the individual's medical and mental condition, behavior, preferences, nursing and medication needs, and ability to function independently.

b. A qualified professional involved in providing services has, in advance, determined that the proposed restriction is necessary for effective treatment of the individual or to protect him or others from personal harm, injury, or death.

c. A qualified professional involved in providing services has, in advance, documented in the individual's services record the specific reason for the restriction.

d. A qualified professional involved in providing services has explained and provided written notice so that the individual can understand the reason for the restriction, the criteria for removal, and the individual's right to a fair review of whether the restriction is permissible.

e. A qualified professional regularly reviews the restriction and that the restriction is discontinued when the individual has met the criteria for removal.

4. If a court has ordered the provider to impose the restriction or if the provider is otherwise required by law to impose the restriction, the restriction shall be documented in the individual's services record.

5. Providers shall obtain approval of the LHRC of any restriction imposed on an individual's rights under this subsection or 12VAC35-115-50 that lasts longer than seven days or is imposed three or more times during a 30-day time period. If the LHRC finds that the restriction is not being implemented in accordance with this chapter, the director shall be notified, and the LHRC shall provide recommendations.

6. Providers may develop and enforce written program rules, but only if the rules do not conflict with this chapter or any ISP and are needed to maintain a safe and orderly environment.

7. Providers shall, in the development of these program rules:

a. Get as many suggestions as possible from all individuals who are expected to obey the rules;

b. Apply these rules in the same way to each individual;

c. Give the rules to and review them with each individual and his authorized representative in a way that the individual can understand them, including explaining possible consequences for violating them;

d. Post the rules in summary form in all areas to which individuals and their families have regular access;

e. Submit the rules to the LHRC for review and approval upon request of the advocate or LHRC; and

f. Prohibit individuals from disciplining other individuals, except as part of an organized self-government program conducted according to a written policy approved in advance by the LHRC.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007; Volume 33, Issue 10, eff. February 9, 2017.

12VAC35-115-105 Behavioral treatment plans

A. A behavioral treatment plan is used to assist an individual to improve participation in normal activities and conditions of everyday living, reduce challenging behaviors, alleviate symptoms of psychopathology, and maintain a safe and orderly environment.

B. Providers may use individualized restrictions such as restraint or time out in a behavioral treatment plan to address challenging behaviors that present an immediate danger to the individual or others, but only after a licensed professional or licensed behavior analyst has conducted a detailed and systematic assessment of the behavior and the situations in which the behavior occurs. Providers shall document in the individual's services record that the lack of success or probable success of less restrictive procedures attempted or considered, and the risks associated with not treating the behavior, are greater than any risks associated with the use of the proposed restrictions.

C. Providers shall develop any behavioral treatment plan according to their policies and procedures, which shall ensure that:

1. Behavioral treatment plans are initiated, developed, carried out, and monitored by professionals who are qualified by expertise, training, education, or credentials to do so;

2. Behavioral treatment plans include nonrestrictive procedures and environmental modifications that address the targeted behavior; and

3. Behavioral treatment plans involving the use of restraint or timeout are submitted to an independent review committee, prior to implementation, for review and approval of the technical adequacy of the plan and data collection procedures.

D. In addition to any other requirements of 42 CFR 483.440(f)(3), providers that are intermediate care facilities for individuals with intellectual disabilities shall submit any behavioral treatment plan that involves the use of restraint or time out, and its independent review committee approval, to the SCC under 42 CFR 483.440(f)(3) for the SCC's approval prior to implementation.

E. Providers other than intermediate care facilities for individuals with intellectual disabilities shall submit any behavioral treatment plan that involves the use of restraint or time out, and its independent review committee approval, to the LHRC, which shall determine whether the plan is in accordance with this chapter prior to implementation.

F. If either the LHRC or SCC finds that the behavioral treatment plan violates the rights of the individual or is not being implemented in accordance with this chapter, the LHRC or SCC shall notify the director and provide recommendations regarding the proposed plan.

G. Behavioral treatment plans involving the use of restraint or time out shall be reviewed quarterly by the independent review committee and the LHRC or SCC to determine if the use of restraint has resulted in improvements in functioning of the individual.

H. Providers shall not use seclusion in a behavioral treatment plan.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 33, Issue 10, eff. February 9, 2017; amended, Virginia Register Volume 35, Issue 2, eff. November 1, 2018.

12VAC35-115-110 Use of seclusion, restraint, and time out

A. Each individual is entitled to be completely free from any unnecessary use of seclusion, restraint, or time out.

B. The voluntary use of mechanical supports to achieve proper body position, balance, or alignment so as to allow greater freedom of movement or to improve normal body functioning in a way that would not be possible without the use of such a mechanical support, and the voluntary use of protective equipment are not considered restraints.

C. The provider's duties.

1. Providers shall meet with the individual or the individual's authorized representative upon admission to the service to discuss and document in the individual's services record his preferred interventions in the event his behaviors or symptoms become a danger to himself or others and under what circumstances, if any, the intervention may include seclusion, restraint, or time out.

2. Providers shall document in the individual's services record all known contraindications to the use of seclusion, time out, or any form of physical or mechanical restraint, including medical contraindications and a history of trauma, and shall flag the record to alert and communicate this information to staff.

3. Seclusion may be used only in an emergency and only in facilities operated by the department; residential facilities for children that are licensed under the Regulations for Children's Residential Facilities (12VAC35-46); inpatient hospitals; and crisis receiving centers or crisis stabilization units that are licensed under Part VIII (12VAC35-105-1830 et seq.) of 12VAC35-105.

4. Providers shall not use seclusion, restraint, or time out as a punishment or reprisal or for the convenience of staff.

5. Providers shall not use seclusion or restraint solely because criminal charges are pending against the individual.

6. Providers shall not use a restraint that places the individual's body in a prone (face down) position.

7. Providers shall not use seclusion or restraint for any behavioral, medical, or protective purpose unless other less restrictive techniques have been considered and documentation is placed in the individual's safety plan, the crisis ISP, or the ISP that these less restrictive techniques did not or would not succeed in reducing or eliminating behaviors that are self-injurious or dangerous to other people or that no less restrictive measure was possible in the event of a sudden emergency.

8. Providers that use seclusion, restraint, or time out shall develop written policies and procedures that comply with applicable federal and state laws and regulations, accreditation and certification standards, third party payer requirements, and sound therapeutic practice. These policies and procedures shall include at least the following requirements:

a. Individuals shall be given the opportunity for motion and exercise, to eat at normal meal times and take fluids, to use the restroom, and to bathe as needed.

b. Trained, qualified staff shall monitor the individual's medical and mental condition continuously while the restriction is being used.

c. Each use of seclusion, restraint, or time out shall end immediately when criteria for removal are met.

d. Incidents of seclusion and restraint, including the rationale for and the type and duration of the restraint, shall be reported to the department as provided in 12VAC35-115-230 C.

9. Providers shall comply with all applicable state and federal laws and regulations, certification and accreditation standards, and third party requirements as they relate to seclusion and restraint.

a. Whenever an inconsistency exists between this chapter and federal laws or regulations, accreditation or certification standards, or the requirements of third party payers, the provider shall comply with the higher standard.

b. Providers shall notify the department whenever a regulatory, accreditation, or certification agency or third party payer identifies problems in the provider's compliance with any applicable seclusion and restraint standard.

10. Providers shall ensure that only staff who have been trained in the proper and safe use of seclusion, restraint, and time out techniques may initiate, monitor, and discontinue their use.

11. Providers shall ensure that a qualified professional who is involved in providing services to the individual reviews every use of physical restraint as soon as possible after it is carried out and documents the results of his review in the individual's services record.

12. Providers shall ensure that review and approval by a qualified professional for the use or continuation of restraint for medical or protective purposes is documented in the individual's services record. Documentation includes:

a. Justification for any restraint;

b. Time-limited approval for the use or continuation of restraint; and

c. Any physical or psychological conditions that would place the individual at greater risk during restraint.

13. Providers may use seclusion or mechanical restraint for behavioral purposes in an emergency only if a qualified professional involved in providing services to the individual has, within one hour of the initiation of the procedure:

a. Conducted a face-to-face assessment of the individual placed in seclusion or mechanical restraint and documented that alternatives to the proposed use of seclusion or mechanical restraint have not been successful in changing the behavior or were not attempted, taking into account the individual's medical and mental condition, behavior, preferences, nursing and medication needs, and ability to function independently;

b. Determined that the proposed seclusion or mechanical restraint is necessary to protect the individual or others from harm, injury, or death;

c. Documented in the individual's services record the specific reason for the seclusion or mechanical restraint;

d. Documented in the individual's services record the behavioral criteria that the individual must meet for release from seclusion or mechanical restraint; and

e. Explained to the individual, in a way that he can understand, the reason for using mechanical restraint or seclusion, the criteria for its removal, and the individual's right to a fair review of whether the mechanical restraint or seclusion was permissible.

14. Providers shall limit each approval for restraint for behavioral purposes or seclusion to four hours for individuals age 18 and older, two hours for children and adolescents ages nine through 17, and one hour for children under age nine.

15. Providers shall not issue standing orders for the use of seclusion or restraint for behavioral purposes.

16. Providers shall ensure that no individual is in time out for more than 30 minutes per episode.

17. Providers shall monitor the use of restraint for behavioral purposes or seclusion through continuous face-to-face observation, rather than by an electronic surveillance device.

D. For purposes of this section, "safety plan," "crisis individualized services plan," or "crisis ISP" shall have the same meaning as those terms are described in 12VAC35-105-1860 and 12VAC35-105-1870.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007; Volume 31, Issue 1, eff. October 8, 2014; Volume 33, Issue 10, eff. February 9, 2017; Volume 40, Issue 22, eff. July 17, 2024.

12VAC35-115-120 Work

A. Individuals have a right to engage or not engage in work or work-related activities consistent with their service needs while receiving services. Personal maintenance and personal housekeeping by individuals receiving services in residential settings are not subject to this provision.

B. The provider's duties.

1. Providers shall not require, entice, persuade, or permit any individual or his family member to perform labor for the provider as a condition of receiving services. If an individual voluntarily chooses to perform labor for the provider, the labor must be consistent with his individualized services plan. All policies and procedures, including pay, must be consistent with the Fair Labor Standards Act (29 USC § 201 et seq.).

2. Providers shall consider individuals who are receiving services for employment opportunities on an equal basis with all other job applicants and employees according to the Americans with Disabilities Act (42 USC § 12101 et seq.).

3. Providers shall give individuals and employers information, training, and copies of policies affecting the employment of individuals receiving services upon request.

4. If vocational training, extended employment services, or supported employment services are offered, providers shall establish procedures for documenting the decision on employment and training and the methodology for establishing wages. Providers shall give a copy of the procedures and information about possible consequences for violating the procedures to all individuals and their authorized representatives.

5. Providers who employ individuals receiving services shall not deduct the cost of services from an individual's wages unless ordered to do so by a court.

6. Providers shall not sell to or purchase goods or services from an individual receiving services except through established governing body policy that is consistent with U.S. Department of Labor standards.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007.

12VAC35-115-130 Research

A. Each individual has a right to choose to participate or not participate in human research.

B. The provider's duties.

1. Providers shall obtain prior, written, informed consent of the individual or his authorized representative before any individual begins to participate in human research unless the research is exempt under § 32.1-162.17 of the Code of Virginia.

2. Providers shall comply with all other applicable state and federal laws and regulations regarding human research, including the provisions under Chapter 5.1 (§ 32.1-162.16 et seq.) of Title 32.1 and § 37.2-402 of the Code of Virginia.

3. Providers shall obtain review and approval from an institutional review board or research review committee prior to performing or participating in a human research protocol. Documentation of this review and approval shall be maintained and made available on request by the individual or his authorized representative.

4. Prior to participation by individuals in any human research project, the provider shall inform and provide a copy of the institutional review board or research review committee approval to the LHRC. Once the research has been initiated, the provider shall update the LHRC periodically on the status of the individual's participation.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007; Volume 33, Issue 10, eff. February 9, 2017.

12VAC35-115-140 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007; repealed, Virginia Register Volume 33, Issue 10, eff. February 9, 2017.

Part IV Substitute Decision Making

12VAC35-115-145 Determination of capacity to give consent or authorization

If the capacity of an individual to consent to treatment, services, or research or to authorize the disclosure of information is in doubt, the provider shall obtain an evaluation conducted by or under the supervision of a licensed professional who is not directly involved with the individual to determine whether the individual has capacity to consent or to authorize the disclosure of information.

1. Capacity evaluations shall be obtained for all individuals who may lack capacity, even if they request that an authorized representative be designated or agree to submit to a recommended course of treatment.

2. In conducting this evaluation, the professional may seek comments from representatives accompanying the individual pursuant to 12VAC35-115-70 A 4 about the individual's capacity to consent or to authorize disclosure.

3. Providers shall determine the need for an evaluation of an individual's capacity to consent or authorize disclosure of information and the need for a substitute decision maker whenever the individual's condition warrants, the individual requests such a review, at least every six months, and at discharge, except for individuals receiving acute inpatient services.

a. If the individual's record indicates that the individual is not expected to obtain or regain capacity, the provider shall document annually that it has reviewed the individual's capacity to make decisions and whether there has been any change in that capacity.

b. Providers of acute inpatient services shall determine the need for an evaluation of an individual's capacity to consent or authorize disclosure of information whenever the individual's condition warrants or at least at every treatment team meeting. Results of such reviews shall be documented in the treatment team notes and communicated to the individual and his authorized representative.

4. Capacity evaluations shall be conducted in accordance with accepted standards of professional practice and shall indicate the specific type of decision for which the individual's capacity is being evaluated (e.g., medical) and shall indicate what specific type of decision the individual has or does not have the capacity to make. Capacity evaluations shall address the type of supports that might be used to increase the individual's decision-making capabilities.

5. If the individual or his family objects to the results of the licensed professional's determination, the provider shall immediately inform the human rights advocate.

a. If the individual or family member wishes to obtain an independent evaluation of the individual's capacity, he may do so at his own expense and within reasonable timeframes consistent with his circumstances. If the individual or family member cannot pay for an independent evaluation, the individual may request that the LHRC consider the need for an independent evaluation pursuant to 12VAC35-115-200 B. The provider shall take no action for which consent or authorization is required, except in an emergency, pending the results of the independent evaluation. The provider shall take no steps to designate an authorized representative until the independent evaluation is complete.

b. If the independent evaluation is consistent with the provider's evaluation, the provider's evaluation is binding, and the provider shall implement it accordingly.

c. If the independent evaluation is not consistent with the provider's evaluation, the matter shall be referred to the LHRC for review and decision under 12VAC35-115-200.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 25, eff. September 19, 2007; amended, Virginia Register Volume 33, Issue 10, eff. February 9, 2017.

12VAC35-115-146 Authorized representatives

A. When it is determined in accordance with 12VAC35-115-145 that an individual lacks the capacity to consent or authorize the disclosure of information, the provider shall recognize and obtain consent or authorization for those decisions for which the individual lacks capacity from the following if available:

1. An attorney-in-fact who is currently empowered to consent or authorize the disclosure under the terms of a durable power of attorney;

2. A health care agent appointed by the individual under an advance directive or power of attorney in accordance with the laws of Virginia; or

3. A legal guardian of the individual, or if the individual is a minor, a parent with legal custody of the minor or other person authorized to consent to treatment pursuant to § 54.1-2969 A of the Code of Virginia.

B. If an attorney-in-fact, health care agent or legal guardian is not available, the director shall designate a substitute decision maker as authorized representative in the following order of priority:

1. The individual's family member. In designating a family member, the director shall honor the individual's preference unless doing so is clinically contraindicated.

a. If the director does not appoint the family member chosen by the individual, the individual shall be told of the reasons for the decision and information about how to request LHRC review according to 12VAC35-115-200.

b. If the individual does not have a preference or if the director does not honor the individual's preference in accordance with these regulations, the director shall select the best qualified person, if available, according to the following order of priority unless, from all information available to the director, another person in a lower priority is clearly better qualified.

(1) A spouse;

(2) An adult child;

(3) A parent;

(4) An adult brother or sister; or

(5) Any other relative of the individual.

2. Next friend of the individual. If no other person specified above is available and willing to serve as authorized representative, a provider may designate a next friend of the individual, after a review and finding by the LHRC that the proposed next friend has, for a period of six months within two years prior to the designation either:

a. Shared a residence with the individual; or

b. Had regular contact or communication with the individual and provided significant emotional, personal, financial, spiritual, psychological, or other support and assistance to the individual.

3. In addition to the conditions set forth in subdivision 2 of this subsection, the individual must have no objection to the proposed next friend being designated as the authorized representative.

4. The person designated as next friend also shall:

a. Personally appear before the LHRC, unless the LHRC has waived the personal appearance; and

b. Agree to accept these responsibilities and act in the individual's best interest and in accordance with the individual's preferences, if known.

5. The LHRC shall have the discretion to waive a personal appearance by the proposed next friend and to allow that person to appear before it by telephone, video, or other electronic means of communication as the LHRC may deem appropriate under the circumstances. Waiving the personal appearance of the proposed next friend should be done in very limited circumstances.

6. If, after designation of a next friend, an appropriate family member becomes available to serve as authorized representative, the director shall replace the next friend with the family member.

C. No director, employee, or agent of a provider may serve as an authorized representative for any individual receiving services delivered by that provider unless the authorized representative is a relative or the legal guardian When a provider, or the director, an employee, or agent of the provider is also the individual's guardian, the provider shall assure that the individual's preferences are included in the services plan and that the individual can make complaints about any aspect of the services he receives.

D. The provider shall document the recognition or designation of an authorized representative in the individual's services record, including evidence of consultation with the individual about his preference, copies of applicable legal documents such as the durable power of attorney, advance directive, or guardianship order, names and contact information for family members, and, when there is more than one potential family member available for designation as authorized representative, the rationale for the designation of the particular family member as the authorized representative.

E. If a provider documents that the individual lacks capacity to consent and no person is available or willing to act as an authorized representative, the provider shall:

1. Attempt to identify a suitable person who would be willing to serve as guardian and ask the court to appoint that person to provide consent or authorization; or

2. Ask a court to authorize treatment (See § 37.2-1101 of the Code of Virginia).

F. Court orders authorizing treatment shall not be viewed as substituting or eliminating the need for an authorized representative.

1. Providers shall review the need for court-ordered treatment and determine the availability of and seek an authorized representative whenever the individual's condition warrants, the individual requests such a review, or at least every six months except for individuals receiving acute inpatient treatment.

2. Providers of acute inpatient services shall review the need for court-ordered treatment and determine the availability of and seek an authorized representative whenever the individual's condition warrants or at least at every treatment team meeting. All such reviews shall be documented in the individual's services record and communicated to the individual.

3. When the provider recognizes or designates an authorized representative, the provider shall notify the court that its order is no longer needed and shall immediately suspend its use of the court order.

G. Conditions for removal of an authorized representative. Whenever an individual has regained capacity to consent as indicated by a capacity evaluation or clinical determination, the director shall immediately remove any authorized representative designated pursuant to subdivision B 1 or 2 of this section, notify the individual and the authorized representative, and ensure that the services record reflects that the individual is capable of making his own decisions. Whenever an individual with an authorized representative who is his legal guardian has regained his capacity to give informed consent, the director may use the applicable statutory provisions to remove the authorized representative. (See § 64.2-2012 of the Code of Virginia.) If powers of attorney and health care agents' powers do not cease of their own accord when a clinician has determined that the individual is no longer incapacitated, the director shall seek the consent of the individual and remove the person as authorized representative.

1. The director shall remove the authorized representative designated pursuant to subdivision B 1 or 2 of this section if the authorized representative becomes unavailable, unwilling, or unqualified to serve. The individual or the advocate may request the LHRC to review the director's decision to remove an authorized representative under the procedures set out at 12VAC35-115-180, and the LHRC may reinstate the authorized representative if it determines that the director's action was unjustified.

2. Prior to any removal under this authority, the director shall notify the individual of the decision to remove the authorized representative, of his right to request that the LHRC review the decision, and of the reasons for the removal decision. This information shall be placed in the individual's services record. If the individual requests, the director shall provide him with a written statement of the facts and circumstances upon which the director relied in deciding to remove the authorized representative.

The LHRC may recommend the removal of a next friend pursuant to 12VAC35-115-200 when the next friend is not acting in accordance with the individual's best interest.

3. The director may otherwise seek to replace an authorized representative recognized pursuant to this section who is an attorney-in-fact currently authorized to consent under the terms of a durable power of attorney, a health care agent appointed by an individual under an advance directive, a legal guardian of the individual, or, if the individual is a minor, a parent with legal custody of the individual, only by a court order under applicable statutory authority.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 23, Issue 25, eff. September 19, 2007; amended, Virginia Register Volume 31, Issue 1, eff. October 8, 2014.

Part V Complaint Resolution, Hearing, and Appeal Procedures

12VAC35-115-150 General provisions

A. Court orders or orders or decisions entered after an administrative hearing are not subject to review under the human rights complaint resolution process.

B. The parties to any complaint are the individual and the director. Each party can also have anyone else represent him during resolution of the complaint. The director shall make every effort to resolve the complaint at the earliest possible stage.

C. Reviews and hearings will generally be closed to other people unless the individual making the complaint requests that other people attend or if an open meeting is required by the Virginia Freedom of Information Act (§ 2.2-3700 et seq. of the Code of Virginia). The LHRC and SHRC may conduct a closed hearing to protect the confidentiality of persons who are not a party to the complaint, but only if a closed meeting is otherwise allowed under the Virginia Freedom of Information Act (see § 2.2-3711 of the Code of Virginia).

D. In no event shall a pending hearing, review, or appeal prevent a director from taking corrective action based on the advice of the provider's legal counsel that such action is required by law or if the director thinks such action is correct and justified.

E. The LHRC or SHRC, on the motion of any party or on its own motion, may, for good cause, extend any time periods before or after the expiration of that time period. No director may extend any time periods for any actions he is required to take under these procedures without prior approval of the LHRC or SHRC.

F. Except in the case of emergency proceedings, if a time period in which action must be taken under this part is not extended by the LHRC or SHRC, the failure of a party to act within that time period shall waive that party's further rights under these procedures.

G. In making recommendations regarding complaint resolution, the LHRC and the SHRC shall identify any rights or regulations that the provider violated and any policies, practices, or conditions that contributed to the violations. They shall also recommend appropriate corrective actions, including changes in policies, practices, or conditions, to prevent further violations of the rights assured under this chapter.

H. If it is impossible to carry out the recommendations of the LHRC or the SHRC within a specified time, the LHRC or the SHRC, as appropriate, shall recommend any necessary interim action that gives appropriate and possible immediate remedies.

I. Any action plan submitted by the director or commissioner in the course of these proceedings shall fully address final and interim recommendations made by the LHRC or the SHRC and identify financial or other constraints, if any, that prevent efforts to fully remedy the violation.

J. All communication with the individual during the complaint resolution process shall be in the manner, format, and language most easily understood by the individual.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007; Volume 33, Issue 10, eff. February 9, 2017.

12VAC35-115-160 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; repealed, Virginia Register Volume 23, Issue 25, eff. September 19, 2007.

12VAC35-115-170 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007; repealed, Virginia Register Volume 33, Issue 10, eff. February 9, 2017.

12VAC35-115-175 Human rights complaint process

A. Each individual has a right to:

1. Make a complaint that the provider has violated any of the rights assured under this chapter;

2. Have a timely and fair review of any complaint in accordance with this chapter and the program's human rights complaint resolution policies and procedures;

3. Have someone file a complaint on his behalf;

4. Use these and other complaint procedures; and

5. Make a complaint under any other applicable law, including to the protection and advocacy agency.

B. The individual shall:

1. Be contacted by the director or the director's designee regarding the complaint within 24 hours;

2. Have access to a human rights advocate for assistance with the complaint;

3. Be protected from retaliation and harm;

4. Have the complaint reviewed, investigated, and resolved as soon as possible;

5. Receive a report with the director's decision and action plan within 10 working days; and

6. Be notified in writing of his right to and the process for appealing the director's decision and action plan to the LHRC.

C. Upon receipt of a complaint, providers shall:

1. Notify the department of the complaint as soon as possible, but no later than the next business day;

2. Ensure that the director or the director's designee contacts the individual regarding the complaint within 24 hours;

3. Initiate an impartial investigation into, or resolution of, the complaint as soon as possible, but no later than the next business day;

4. Take all steps necessary to ensure that individuals involved in the complaint are protected from retaliation and harm;

5. Assist the individual making a complaint in understanding the human rights complaint process, the provider's complaint resolution policies and procedures, and the confidentiality of involved information;

6. Ensure that all communications to the individual are in the manner, format, and language most easily understood by the individual;

7. Adhere to the reporting requirements in 12VAC35-115-230; and

8. Report the director's decision and action plan within 10 working days to the individual, authorized representative, if applicable, and human rights advocate.

D. All providers shall have complaint resolution policies and procedures that address all of the requirements of subsections C and E of this section.

E. Provider complaint resolution policies and procedures shall be in writing and approved by the department prior to implementation. The policies and procedures shall:

1. Ensure that anyone who believes that a provider has violated an individual's rights under this chapter can report it to the director or the human rights advocate for resolution;

2. Ensure that employees shall not take, threaten to take, permit, or condone any action (i) to punish or retaliate against anyone filing a complaint or (ii) to prevent anyone from filing or helping an individual file a complaint either under this chapter or with an outside entity;

3. Ensure that every attempt is made to resolve an individual's complaint as quickly as possible;

4. Provide opportunities for timely negotiation and resolution for all complaints, including the additional requirements related to abuse, neglect, or exploitation in subsection F of this section;

5. Establish a process for designating the director's responsibilities to ensure timely complaint reporting and resolution;

6. Detail the program's complaint review or investigation process, including (i) specific actions the program will take to protect the individual and gather and document relevant information and (ii) how and when the individual and his authorized representative, if applicable, will receive updates on the progress of the review;

7. Detail notification requirements and deadlines including procedures for providing:

a. The program's complaint policies and procedures to all individuals and authorized representatives at admission to service; and

b. Written notification to the individual regarding his right to and the process to appeal the director's decision and action plan to the LHRC; and

8. Detail staff training requirements regarding the program's complaint resolution process and requirements.

F. Additional requirements for complaints involving abuse, neglect, or exploitation:

1. The program director shall take immediate steps to protect the individual until the investigation is complete, including appropriate personnel actions.

2. Any instance of seclusion or restraint that does not comply with this chapter or an approved variance, or that results in injury to an individual, shall be reported to the authorized representative, as applicable, and the department in accordance with the requirements for reporting allegations of abuse.

3. The program director shall notify the department and authorized representative, if applicable, of an allegation of abuse or neglect within 24 hours of the receipt of the allegation.

4. The program director shall ensure that the investigation is conducted by a person trained to do investigations and who is not involved in the issues under investigation.

5. The investigator shall provide a written report of the results of the investigation of abuse or neglect to the director and to the human rights advocate within 10 working days from the date the investigation began unless an extension has been granted.

6. The program director shall decide, based on the investigator's report and any other available information, whether the abuse, neglect, or exploitation occurred. Unless otherwise provided by law, the standard for deciding whether abuse, neglect, or exploitation has occurred is preponderance of the evidence.

7. The program director shall submit the final decision and action plan, if applicable, to the individual, authorized representative, if applicable, and human rights advocate within 10 working days of its completion.

G. If the human rights advocate concludes that there is substantial risk that serious or irreparable harm will result if the complaint is not resolved immediately, the human rights advocate shall inform the director, the provider's governing body, and the LHRC. The LHRC shall conduct a hearing according to the special procedures for emergency hearings in 12VAC35-115-190.

H. The director shall cooperate fully with any abuse or neglect complaint investigation conducted by a local department of social services.

I. If at any time the director has reason to suspect that the abusive, neglectful, or exploitive act is a crime and that it occurred on the program premises, the director or designee shall immediately contact the appropriate law-enforcement authorities and cooperate fully with any investigation that may result.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 33, Issue 10, eff. February 9, 2017.

12VAC35-115-180 Local human rights committee hearing and review procedures

A. Any individual or his authorized representative who disagrees with a director's final decision or action plan resulting from any complaint resolution process under this chapter may request an LHRC hearing by following the process described in this section.

B. The individual or his authorized representative shall file the petition for a hearing with the chairperson of the LHRC within 10 working days from receipt of the director's action plan or final decision on the complaint.

1. The petition for hearing shall be in writing. It shall contain all facts and arguments surrounding the complaint and reference any section of this chapter that the individual believes the provider violated.

2. The human rights advocate or any person the individual chooses may help the individual in filing the petition. If the individual chooses a person other than the human rights advocate to help him, he and his chosen representative may request the human rights advocate's assistance in filing the petition.

C. The LHRC chair shall forward a copy of the petition to the director and the human rights advocate as soon as he receives it. A copy of the petition shall also be forwarded to the provider's governing body.

D. Within five working days, the director shall submit to the LHRC:

1. A written response to everything contained in the petition; and

2. A copy of the entire written record of the complaint.

E. LHRC hearing procedures:

1. The LHRC shall hold a hearing within 20 working days of receiving the petition.

2. The parties shall have at least five working days' notice of the hearing.

3. The director or his designee shall attend the hearing.

4. The individual or his authorized representative making the complaint shall attend the hearing.

5. The hearing is an informal process and, as such, the rules of evidence are not applicable.

6. At the hearing, the parties and chosen representatives and designees have the right to present witnesses and other evidence and the opportunity to be heard.

7. The hearing shall be conducted in a nonadversarial manner.

a. Each party shall be provided the opportunity to present its facts.

b. Each party shall direct questions to the LHRC rather than to the other party.

c. The LHRC shall ask questions, as appropriate, to each party.

F. Within 10 working days after the hearing ends, the LHRC shall give its written findings of fact and recommendations to the parties and their representatives. Whenever appropriate, the LHRC shall identify information that it believes the director shall take into account in making decisions concerning discipline or termination of personnel.

G. Within five working days of receiving the LHRC's findings and recommendations, the director shall give the individual, the individual's chosen representative, the human rights advocate, the governing body, and the LHRC a written action plan he intends to implement to respond to the LHRC's findings and recommendations. Along with the action plan, the director shall provide written notice to the individual about the timeframe for the individual's response and a statement that if the individual does not respond, then the complaint will be closed. The plan shall not be implemented for five working days after it is submitted, unless the individual agrees to its implementation sooner.

H. The individual, his chosen representative, the human rights advocate, or the LHRC may object to the action plan within five working days by stating the objection and what the director can do to resolve the objection.

1. If an objection is made, the director may not implement the action plan until the objection is resolved. The provider may, however, implement any portion of the plan to which the individual making the complaint agrees.

2. If no one objects to the action plan, the director shall begin to implement the plan on the sixth working day after he submitted it, or as otherwise provided in the plan.

I. If an objection to the action plan is made and the director does not resolve the objection to the action plan to the individual's satisfaction within two working days following its receipt by the director, the individual may appeal to the SHRC under 12VAC35-115-210.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007; Volume 33, Issue 10, eff. February 9, 2017.

12VAC35-115-190 Special procedures for emergency hearings by the LHRC

A. If the human rights advocate informs the LHRC of a substantial risk that serious and irreparable harm will result if a complaint is not resolved immediately, the LHRC shall hold and conclude a preliminary hearing within 72 hours of receiving this information.

1. The director or his designee and the human rights advocate shall attend the hearing. The individual and his authorized representative may attend the hearing.

2. The hearing shall be conducted according to the procedures in 12VAC35-115-180, but it shall be conducted on an expedited basis.

B. At the end of the hearing, the LHRC shall make preliminary findings and, if a violation is found, shall make preliminary recommendations to the director, the provider, and the provider's governing body.

C. The director shall formulate and carry out an action plan within 24 hours of receiving the LHRC's preliminary recommendations. A copy of the plan shall be sent to the human rights advocate, the individual, his authorized representative, and the governing body.

D. If the individual or the human rights advocate objects within 24 hours to the LHRC findings or recommendations or to the director's action plan, the LHRC shall conduct a full hearing within five working days of the objection, following the procedures outlined in 12VAC35-115-180. This objection shall be made in writing to the LHRC chairperson, with a copy sent to the director.

E. Either party may appeal the LHRC's decision to the SHRC under 12VAC35-115-210.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007; Volume 33, Issue 10, eff. February 9, 2017.

12VAC35-115-200 Special procedures for LHRC reviews involving consent and authorization

A. The individual, his authorized representative, or anyone acting on the individual's behalf may request in writing that the LHRC review the following situations and issue a decision:

1. If an individual objects at any time to the appointment of a specific person as his authorized representative or any decision for which consent or authorization is required and has been given by his authorized representative, other than a legal guardian, he may ask the LHRC to decide whether his capacity was properly evaluated, the authorized representative was properly appointed, or his authorized representative's decision was made based on the individual's basic values and any preferences previously expressed by the individual to the extent that they are known, and if unknown or unclear in the individual's best interests.

a. The provider shall take no action for which consent or authorization is required if the individual objects, except in an emergency or as otherwise permitted by law, pending the LHRC review.

b. If the LHRC determines that the individual's capacity was properly evaluated, the authorized representative is properly designated, or the authorized representative's decision was made based on the individual's basic values and any preferences previously expressed by the individual to the extent that they are known, or if unknown or unclear in the individual's best interests, then the provider may proceed according to the decision of the authorized representative.

c. If the LHRC determines that the individual's capacity was not properly evaluated or the authorized representative was not properly designated, then the provider shall take no action for which consent is required except in an emergency or as otherwise required or permitted by law until the capacity review and authorized representative designation are properly done.

d. If the LHRC determines that the authorized representative's decision was not made based on the individual's basic values and any preference previously expressed by the individual to the extent known, and if unknown or unclear, made in the individual's best interests, then the provider shall take steps to remove the authorized representative pursuant to 12VAC35-115-146.

2. If an individual or his family member has obtained an independent evaluation of the individual's capacity to consent to treatment or services or to participate in human research, or to authorize the disclosure of information under 12VAC35-115-80, and the opinion of that evaluator conflicts with the opinion of the provider's evaluator, the LHRC may be requested to decide which evaluation will control.

a. If the LHRC agrees that the individual lacks the capacity to consent to treatment or services or authorize disclosure of information, the director may begin or continue treatment or research or disclose information, but only with the appropriate consent or authorization of the authorized representative. The LHRC shall advise the individual of his right to appeal this determination to the SHRC under 12VAC35-115-210.

b. If the LHRC does not agree that the individual lacks the capacity to consent to treatment or services or authorize disclosure of information, the director shall not begin any treatment or research, or disclose information without the individual's consent or authorization, or shall take immediate steps to discontinue any actions begun without the consent or authorization of the individual. The director may appeal to the SHRC under 12VAC35-115-210 but may not take any further action until the SHRC issues its opinion.

3. If a director makes a decision that affects an individual and the individual believes that the decision requires his personal consent or authorization or that of his authorized representative, he may object and ask the LHRC to decide whether consent or authorization is required.

Regardless of the individual's capacity to consent to treatment or services or to authorize disclosure of information, if the LHRC determines that a decision made by a director requires consent or authorization that was not obtained, the director shall immediately stop such action unless and until such consent or authorization is obtained. The director may appeal to the SHRC under 12VAC35-115-210 but may not take any further action until the SHRC issues its opinion.

B. Before making such a decision, the LHRC shall review the action proposed by the director, any determination of lack of capacity, the opinion of the independent evaluator if applicable, and the individual's or his authorized representative's reasons for objecting to that determination. To facilitate its review, the LHRC may ask that a physician or licensed clinical psychologist not employed by the provider evaluate the individual at the provider's expense and give an opinion about his capacity to consent to treatment or to authorize disclosure of information.

The LHRC shall notify all parties and the human rights advocate of the decision within 10 working days of the initial request.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007; Volume 33, Issue 10, eff. February 9, 2017.

12VAC35-115-210 State Human Rights Committee appeals procedures

A. Any party may appeal to the SHRC if he disagrees with any of the following:

1. An LHRC's final findings of fact, conclusions, and recommendations following a hearing;

2. A director's final action plan following an LHRC hearing;

3. An LHRC's final decision regarding the capacity of an individual to consent to treatment, services, or research or to authorize disclosure of information; or

4. An LHRC's final decision concerning whether consent or authorization is needed for the director to take a certain action.

The steps for filing an appeal are provided in subsections B, C, and D of this section.

B. Appeals shall be filed in writing with the SHRC by a party within 10 working days of receipt of the final decision or action plan.

1. The appeal shall explain the reasons for disagreement with the final decision or action plan.

2. The human rights advocate or any other person may help in filing the appeal. If the individual chooses a person other than the human rights advocate to help him, he and his chosen representative may request the human rights advocate's help in filing the appeal.

3. The party appealing shall give a copy of the appeal to the other party, the human rights advocate, and the LHRC.

4. If the director is the party appealing, he shall first request and get written permission to appeal from the commissioner or governing body of the provider, as appropriate. If the director does not get this written permission and note the appeal within 10 working days, his right to appeal is waived.

C. If the director is appealing, the individual may file a written statement with the SHRC within five working days after receiving a copy of the appeal. If the individual is appealing, the director shall file a written statement with the SHRC within five working days after receiving a copy of the appeal.

D. Within five working days of noting or being notified of an appeal, the director shall forward a complete record of the LHRC hearing to the SHRC. The record shall include, at a minimum:

1. The original petition or information filed with the LHRC and any statement filed by the director in response;

2. Parts of the individual's services record that the LHRC considered and any other parts of the services record submitted to, but not considered by, the LHRC that either party considers relevant;

3. All written documents and materials presented to and considered by the LHRC, including any independent evaluations conducted;

4. A tape or transcript of the LHRC proceedings, if available;

5. The LHRC's findings of fact, conclusions, and recommendations;

6. The director's action plan, if any; and

7. Any written objections to the action plan or its implementation.

E. The SHRC shall hear the appeal at its next scheduled meeting after the chairperson receives the appeal.

1. The SHRC shall give the parties at least 10 working days' notice of the appeal hearing.

2. The SHRC shall notify the Office of the State Inspector General (§ 2.2-308 of the Code of Virginia) of the appeal.

3. The following rules govern appeal hearings:

a. The SHRC shall not hear any new evidence.

b. The SHRC is bound by the LHRC's findings of fact unless it makes a determination that those findings of fact are clearly wrong or that the hearing procedures of the LHRC were inadequate.

c. The SHRC shall limit its review to whether the facts, as found by the LHRC, establish a violation of this chapter and a determination of whether the LHRC's recommendations or the action plan adequately address the alleged violation.

d. All parties and their representatives shall have the opportunity to appear before the SHRC to present their positions and answer questions the SHRC may have.

4. If the SHRC decides that the LHRC's findings of fact are clearly wrong or that the hearing procedures employed by the LHRC were inadequate, the SHRC may:

a. Send the case back to the LHRC for another hearing to be completed within a time period specified by the SHRC; or

b. Conduct its own fact-finding hearing. If the SHRC chooses to conduct its own fact-finding hearing, it may appoint a subcommittee of at least three of its members as fact finders. The fact-finding hearing shall be conducted within 30 working days of the SHRC's initial hearing.

In either case, the parties shall have 15 working days' notice of the date of the hearing and the opportunity to be heard and to present witnesses and other evidence.

F. Within 20 working days after the SHRC appeal hearing, the SHRC shall submit a decision containing its findings of fact, if applicable, and its conclusions and recommendations to the commissioner and to the provider's governing body, with copies to the parties, the LHRC, and the human rights advocate.

G. Within 10 working days after receiving the SHRC's decision, in the case of appeals involving a state facility, the commissioner shall submit an outline of actions to be taken in response to the SHRC's recommendations. In the case of appeals involving CSBs and private providers, the director shall outline in writing the action or actions that will be taken in response to the recommendations of the SHRC. They shall also explain any reasons for not carrying out any of the recommended actions. Copies of their responses shall be forwarded to the SHRC, the LHRC, the director, the human rights advocate, and the individual.

H. If the SHRC objects in writing to the commissioner's or director's proposed actions, their actions shall be postponed. The commissioner or director shall meet with the SHRC at its next regularly scheduled meeting to attempt to arrange a mutually agreeable resolution.

I. Final determination regarding the action plan shall be as follows:

1. In the case of services provided directly by the department, the commissioner's action plan shall be final and binding on all parties. However, when the SHRC believes the commissioner's action plan is incompatible with the purpose of this chapter, it shall notify the board, the protection and advocacy agency, and the Office of the State Inspector General (§ 2.2-308 of the Code of Virginia).

2. In the case of services delivered by all other providers, the action plan of the director shall be reviewed by the commissioner. If the commissioner determines that the provider has failed to develop and carry out an acceptable action plan, the commissioner shall notify the protection and advocacy agency and shall inform the SHRC of the sanctions the department will impose against the provider.

J. Upon completion of the process outlined in this section, the SHRC shall notify the parties and the human rights advocate of the final outcome of the complaint.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007; Volume 31, Issue 1, eff. October 8, 2014; Volume 33, Issue 10, eff. February 9, 2017.

Part VI Variances

12VAC35-115-220 Variances

A. Variances to these regulations shall be requested and approved only when the provider has tried to implement the relevant requirement without a variance and can provide objective, documented information that continued operation without a variance is not feasible or will prevent the delivery of effective and appropriate services and supports to individuals.

B. Only directors may apply for variances, and they must first be approved by the provider, the governing body of the provider, or the commissioner, as appropriate, before consideration by an LHRC or the SHRC.

C. Upon receiving approval from the governing body or commissioner, and after notifying the human rights advocate and other interested persons, the director shall file a formal application for variance with the LHRC. This application shall reference the specific part of these regulations to which a variance is needed, the proposed wording of the substitute rule or procedure, and the justification for a variance. The application shall also describe time limits and other conditions for duration and the circumstances that will end the applicability of the variance.

1. When the LHRC receives the application, it shall invite, and provide ample time to receive, oral or written statements about the application from the human rights advocate, individuals affected by the variance, and other interested persons.

2. The LHRC shall review the application and prepare a written report of facts, which shall include its recommendation for approval, disapproval, or modification. The LHRC shall send its report, recommendations, and a copy of the original application to the State Human Rights Director, the SHRC, and the director making application for the variance.

D. When the SHRC receives the application and the LHRC's report, the SHRC shall do the following:

1. Invite oral or written statements about the application from the applicant director, LHRC, advocate, and other interested persons by publishing the request for variance in the next issue of the Virginia Register of Regulations;

2. Notify the Office of the State Inspector General (§ 2.2-308 of the Code of Virginia) of the request for variance; and

3. After considering all available information, prepare a written decision deferring, disapproving, modifying, or approving the application. All variances shall be approved for a specific time period and must be reviewed at least annually.

a. A copy of this decision including conditions, time frames, circumstances for removal, and the reasons for the decision shall be given to the applicant director, the commissioner or governing body, the state human rights director, the human rights advocate, any person commenting on the request at any stage, and the LHRC.

b. The decision and reasons shall also be published in the next issue of the Virginia Register of Regulations.

E. Directors shall implement any approved variance in strict compliance with the written application as amended, modified, or approved by the SHRC.

F. Providers shall develop policies and procedures for monitoring the implementation of any approved variances. These policies and procedures shall specify that at no time can a variance approved for one individual be extended to general applicability. These policies and procedures shall assure the ongoing collection of any data relevant to the variance and the presentation of any later report concerning the variance as requested by the commissioner, the state human rights director, the human rights advocate, the LHRC or the SHRC.

G. The decision of the SHRC granting or denying a variance shall be final.

H. Following the granting of a variance, the provider shall notify all individuals affected by the variance about the details of the variance.

I. If an individual is in immediate danger due to a provider's implementation of these regulations, the provider may request a temporary variance pending approval pursuant to the process described in this section. Such a request shall be submitted in writing to the commissioner, chairperson of the SHRC, and state human rights director. The commissioner, chairperson of the SHRC, and state human rights director shall issue a decision within 48 hours of the receipt of such a request.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007; Volume 31, Issue 1, eff. October 8, 2014.

Part VII Reporting Requirements

12VAC35-115-230 Provider requirements for reporting

A. Providers shall collect, maintain, and report the following information concerning abuse, neglect, and exploitation:

1. The director of a facility operated by the department shall report allegations of abuse and neglect via the department's web-based reporting application in accordance with all applicable operating instructions issued by the commissioner or his designee.

2. The director of a service licensed or funded by the department shall report each allegation of abuse or neglect via the department's web-based reporting application within 24 hours of receipt of the allegation (see 12VAC35-115-175).

3. The investigating authority shall provide a written report of the results of the investigation of abuse or neglect to the director and human rights advocate via the department's web-based reporting application within 10 working days from the date the investigation began unless an extension has been granted (see 12VAC35-115-175). This report shall include:

a. Whether abuse, neglect, or exploitation occurred;

b. The type of abuse; and

c. Whether the act resulted in physical or psychological injury.

B. Providers shall collect, maintain, and report the following information concerning deaths and serious injuries:

1. The director of a facility operated by the department shall report to the department deaths and serious injuries in accordance with all applicable operating instructions issued by the commissioner or his designee.

2. The director of a service licensed or funded by the department shall report deaths and serious injuries in writing to the department within 24 hours of discovery and by telephone to the authorized representative within 24 hours.

3. All reports of death and serious injuries shall include:

a. Date and place of the death or serious injury;

b. Nature of the injuries and treatment required; and

c. Circumstances of the death or serious injury.

C. Providers shall collect, maintain and report the following information concerning seclusion and restraint:

1. The director of a facility operated by the department shall report each instance of seclusion or restraint or both in accordance with all applicable operating instructions issued by the commissioner or his designee.

2. The director of a service licensed or funded by the department shall submit an annual report of each instance of seclusion or restraint or both by the 15th of January each year, or more frequently if requested by the department.

3. Each instance of seclusion or restraint or both shall be compiled on a monthly basis and the report shall include:

a. Type or types, to include:

(1) Physical restraint (manual hold);

(2) Mechanical restraint;

(3) Pharmacological restraint; or

(4) Seclusion.

b. Rationale for the use of seclusion or restraint, to include:

(1) Behavioral purpose;

(2) Medical purpose; or

(3) Protective purpose.

c. Duration of the seclusion or restraint, as follows:

(1) The duration of seclusion and restraint used for behavioral purposes is defined as the actual time the individual is in seclusion or restraint from the time of initiation of seclusion or restraint until the individual is released.

(2) The duration of restraint for medical and protective purposes is defined as the length of the episode as indicated in the order.

4. Any instance of seclusion or restraint that does not comply with this chapter or approved variances, or that results in injury to an individual, shall be reported to the authorized representative, as applicable, and to the department via the department's web-based reporting application within 24 hours.

D. Providers shall report to the human rights advocate and the LHRC when requested information on each complaint of a human rights violation, including a description and its conclusions, and report on implementation of variances, in accordance with the LHRC meeting schedule.

E. Reports required under this section shall be submitted to the department on forms or in an automated format or both developed by the department.

F. The department shall compile all data reported under this section and make this data available to the public and the Office of the State Inspector General (§ 2.2-308 of the Code of Virginia) upon request.

1. The department shall provide the compiled data in writing or by electronic means.

2. The department shall remove all provider-identifying information and all information that could be used to identify a person as an individual receiving services.

G. In the reporting, compiling, and releasing of information and statistical data provided under this section, the department and all providers shall take all measures necessary to ensure that any information identifying individuals is not disclosed to the public, including encryption of data transferred by electronic means.

H. Nothing in this section is to be construed as requiring the reporting of proceedings, minutes, records, or reports of any entity that are identified as privileged pursuant to § 8.01-581.17 of the Code of Virginia.

I. Providers shall report to the Department of Health Professions, Enforcement Division, violations of this chapter that constitute reportable conditions under state law.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007; Volume 31, Issue 1, eff. October 8, 2014; Volume 33, Issue 10, eff. February 9, 2017.

Part VIII Enforcement and Sanctions

12VAC35-115-240 Human rights enforcement and sanctions

A. The commissioner may invoke the sanctions enumerated in § 37.2-419 of the Code of Virginia upon receipt of information that a provider licensed or funded by the department is:

1. In violation of (i) the provisions of § 37.2-400 and §§ 37.2-403 through 37.2-422 of the Code of Virginia, (ii) these regulations, or (iii) provisions of the licensing regulations adopted pursuant to §§ 37.2-404 and 37.2-411 of the Code of Virginia; and

2. The violation adversely affects the human rights of individuals or poses an imminent and substantial threat to the health, safety, or welfare of individuals.

The commissioner shall notify the provider in writing of the specific violation or violations found and of his intention to convene an informal conference pursuant to § 2.2-4019 of the Code of Virginia at which the presiding officer will be asked to recommend issuance of a special order.

B. The sanctions contained in the special order shall remain in effect for the duration of any appeal of the special order.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007.

Part IX Responsibilities and Duties

12VAC35-115-250 (Repealed.)

History

• Historical Notes: Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; Errata, 18:6 VA.R. December 3, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007; repealed, Virginia Register Volume 33, Issue 10, eff. February 9, 2017.

12VAC35-115-260 Provider and department responsibilities

A. Providers, through their directors, shall:

1. Designate a person or persons responsible for helping individuals exercise their rights and resolve complaints regarding services;

2. Take all steps necessary to perform duties required by, and ensure compliance with, this chapter in all services provided;

3. Post information in program locations about the existence and purpose of the human rights program;

4. Communicate information about the availability of a human rights advocate to individuals and authorized representatives, in accordance with 12VAC35-115-40 B 1 and B 2;

5. Ensure access, as needed, to the LHRC for all individuals receiving services;

6. Provide the human rights advocate unrestricted access to an individual and his services records whenever the advocate deems access is necessary to carry out rights protection, complaint resolution, and advocacy on behalf of the individual;

7. Require competency-based training of employees on this chapter upon employment and at least annually thereafter. Documentation of such competency shall be maintained in the employee's personnel file;

8. Comply with all state laws governing the reporting of abuse and neglect and all procedures set forth in this chapter for reporting allegations of abuse, neglect, or exploitation;

9. Submit to the human rights advocate for review and comment proposed policies, procedures, or practices that may affect individual human rights;

10. Ensure appointment of a designated liaison to, and appropriate staff participation with, the LHRC, as required;

11. Cooperate with the human rights advocate and the LHRC to investigate and correct conditions or practices interfering with the free exercise of individuals' human rights and make sure that all employees cooperate with the human rights advocate, the LHRC, and the SHRC in carrying out their duties under this chapter;

12. Comply with requests by the SHRC, LHRC, or human rights advocate for information, policies, procedures, and written reports regarding compliance with this chapter;

13. Ensure the availability of records and employee witnesses upon the request of the LHRC or SHRC;

14. Submit applications for variances to this chapter only as a last resort; and

15. Not influence or attempt to influence the appointment of any person to an LHRC affiliated with the provider or director.

B. Providers shall require their employees to:

1. Become familiar with this chapter, comply with it in all respects, and help individuals understand and assert their rights;

2. Protect individuals from any form of abuse, neglect, or exploitation by:

a. Not abusing, neglecting, or exploiting any individual;

b. Using the minimum force necessary to restrain an individual;

c. Not permitting or condoning anyone else abusing, neglecting, or exploiting any individual; and

d. Reporting all suspected abuse, neglect, or exploitation to the director; and

3. Cooperate with any investigation, meeting, hearing, or appeal held under this chapter. Cooperation includes giving statements or sworn testimony.

C. Department human rights advocates shall:

1. Represent any individual making a complaint or, upon request, consult with and help any other representative the individual chooses;

2. Provide training to individuals, family members, and providers on this chapter;

3. Investigate and try to prevent or correct any alleged rights violation by interviewing, mediating, negotiating, advising, or consulting with providers and their respective governing bodies, directors, and employees;

4. Provide orientation, training, and technical assistance to the LHRCs for which he is responsible; and

5. Investigate and examine all conditions or practices that may interfere with the free exercise of individuals' rights.

D. The department shall:

1. Employ the state human rights director to lead statewide implementation of the human rights program;

2. Determine, in consultation with the SHRC, the appropriate number and geographical boundaries of LHRCs;

3. Develop information, assistance, training tools, and other resources for individuals and constituents on this chapter;

4. Provide for regular monitoring and enforcement of this chapter, including conducting unannounced compliance reviews at any time;

5. Cooperate with and provide support to the SHRC and LHRCs, including:

a. Training SHRC and LHRC members on their responsibilities, roles, and functions under this chapter;

b. Providing access to topic area consultants as needed to support their fulfilling of their duties under this chapter; and

c. Providing necessary support for SHRC and LHRC investigations, meetings, and hearings; and

6. Maintain current and regularly updated data and perform regular trend analyses to identify the need for corrective action in the areas of abuse, neglect, and exploitation; seclusion and restraint; complaints; deaths and serious injuries; and variance applications.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 33, Issue 10, eff. February 9, 2017.

12VAC35-115-270 State Human Rights Committee and local human rights committees responsibilities

A. Local human rights committees shall:

1. Review any restriction on the rights of any individual imposed pursuant to 12VAC35-115-50 or 12VAC35-115-100 that lasts longer than seven days or is imposed three or more times during a 30-day period for providers within the LHRC's jurisdiction in accordance with 12VAC35-115-100 B 5;

2. Review next friend designations in accordance with 12VAC35-115-146 B 2;

3. Hold hearings according to the procedures set forth in Part V (12VAC35-115-150 et seq.) of this chapter for any individual served by a provider under the LHRC's jurisdiction;

4. Review behavioral treatment plans in accordance with 12VAC35-115-105;

5. Receive, review, and act on applications for variances to this chapter in accordance with 12VAC35-115-220;

6. Consist of five or more members appointed by the SHRC.

a. Membership shall be broadly representative of professional and consumer interests as required in § 37.2-204 of the Code of Virginia.

b. At least one member shall be a health care provider.

c. No current employee of the department or a provider shall serve as a member of any LHRC that serves an oversight function for the employing facility or provider.

d. Members shall recuse themselves from all cases in which they have a financial or other conflict of interest.

e. Initial appointments to an LHRC shall be staggered, with approximately one-third of the members appointed for terms of three years, approximately one-third for terms of two years, and the remainder for a term or terms of one year. After that, all appointments shall be for terms of three years.

f. A person may be appointed for no more than two consecutive three-year terms. A person appointed to fill a vacancy may serve out that term and then be eligible for two additional consecutive terms.

g. Nominations for membership to LHRCs shall be submitted directly to the SHRC through the state human rights director at the department's Office of Human Rights;

7. Elect a chairperson from its own members who shall:

a. Coordinate the activities of the LHRC; and

b. Preside at regular meetings and hearings held pursuant to this chapter;

8. Meet every quarter or more frequently as necessary to adhere to all timelines as set forth in this chapter; and

9. Adopt written bylaws that address procedures for conducting business; electing the chairperson, secretary, and other officers; designating standing committees; and setting the frequency of meetings.

B. Local human rights committees may delegate authority to a subcommittee when expedited decisions are required before the next scheduled LHRC meeting to avoid seriously compromising an individual's quality of care, habilitation, or quality of life. The decision of the subcommittee shall be reviewed by the full LHRC at its next meeting.

C. The State Human Rights Committee shall:

1. Perform the following responsibilities with respect to the operation of LHRCs:

a. Appoint LHRC members with the advice of the respective LHRC, human rights advocate, and the state human rights director;

b. Review and approve the bylaws of LHRCs; and

c. Provide oversight to and assist LHRCs in the performance of their duties under this chapter, including the development of guidance documents;

2. Review LHRC decisions when required by this chapter and, if appropriate, hold hearings and make recommendations to the commissioner, the board, and providers' governing bodies regarding alleged violations of individuals' rights according to the procedures specified in this chapter;

3. Notify the commissioner and the state human rights director whenever it determines that its recommendations in a particular case are of general interest and applicability to providers, human rights advocates, or LHRCs and ensure that:

a. Its recommendations are communicated to providers, human rights advocates, and LHRCs as appropriate; and

b. The communication of its recommendations does not identify the name of individuals or employees in a particular case;

4. Grant or deny variances according to the procedures specified in Part VI (12VAC35-115-220) of this chapter and review approved variances at least once every year;

5. Submit to the board and publish an annual report of its activities and the status of human rights in services licensed, funded, or operated by the department and make recommendations for improvement;

6. Evaluate the implementation of this chapter and make necessary and appropriate recommendations to the board, the commissioner, and the state human rights director concerning its interpretation and enforcement;

7. Review and make recommendations to the department and board, as appropriate, concerning:

a. The scope and content of training programs designed by the department to promote responsible performance of the duties assigned under this chapter;

b. Existing or proposed policies, procedures, or practices that could jeopardize the rights of individuals receiving services from any provider;

c. Proposed revisions to this chapter; and

d. Revisions to existing or proposed laws, regulations, policies, procedures, and practices that are needed to ensure the protection of individuals' rights;

8. Consist of nine members appointed by the board.

a. Members shall be broadly representative of professional and consumer interests as required in § 37.2-204 of the Code of Virginia;

b. Members shall recuse themselves from all cases in which they have a financial or other conflict of interest;

c. If there is a vacancy, interim appointments may be made by the board for the remainder of the unexpired term;

d. A person may be appointed for no more than two consecutive three-year terms. A person appointed to fill a vacancy may serve out that term and then be eligible for two additional consecutive terms; and

e. No current employee of the department, a CSB, or a behavioral health authority may serve as a member of the SHRC;

9. Elect a chairperson from its own members who shall:

a. Coordinate the activities of the SHRC;

b. Preside at regular meetings, hearings, and appeals; and

c. Have direct access to the commissioner and the board in carrying out these duties;

10. Conduct at least eight regular meetings per year; and

11. Adopt written bylaws that address procedures for conducting business; making membership recommendations to the board; electing a chairperson, vice chairperson, secretary, and other officers; appointing members of LHRCs; designating standing committees and their responsibilities; establishing ad hoc committees; and setting the frequency of meetings.

History

• Statutory Authority: §§ 37.2-203 and 37.2-400 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 33, Issue 10, eff. February 9, 2017.

Chapter 225 Requirements for Virginia Early Intervention System

Part I Authority and Definitions

12VAC35-225-10 Authority

A. Pursuant to § 2.2-5304 of the Code of Virginia, the Governor has designated the Department of Behavioral Health and Developmental Services as the state lead agency responsible for implementing the Virginia early intervention services system and ensuring compliance with federal requirements.

B. Sections 2.2-2664, 2.2-5301, 2.2-5303, 2.2-5304, 2.2-5305, and 2.2-5306 of the Code of Virginia establish the structure of Virginia's early intervention system, including the duties and responsibilities of the state lead agency, coordinating council, and participating agencies.

C. Virginia's early intervention system, the Infant & Toddler Connection of Virginia, must include, at a minimum, the components required by Part C of the Individuals with Disabilities Education Act at 20 USC § 1435(a) and at 34 CFR Part 303.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-20 Definitions

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Ability to pay" means the amount a family is able to contribute toward the cost of early intervention services, based on family size, income, and expenses.

"Adjusted age" means an adjustment that is made for premature birth (gestation less than 37 weeks) used to determine developmental status until the child is 18 months of age.

"Administrative complaint" means a written, signed complaint by an individual or organization alleging that the department, local lead agency, or early intervention service provider violated a requirement of Part C or this chapter.

"Assessment" means the ongoing procedures used by qualified early intervention service providers to identify (i) the child's unique strengths and needs and the concerns of the family; (ii) the early intervention services appropriate to meet those needs throughout the period of the child's eligibility under Part C; and (iii) the resources, priorities, and supports and services necessary to enhance the family's capacity to meet the developmental needs of the child.

"Assistive technology device" means any item, piece of equipment, or product system, whether acquired commercially off the shelf, modified, fabricated, or customized, that is used to increase, maintain, or improve functional capabilities of a child. The term does not include a medical device that is surgically implanted, such as a cochlear implant, or the optimization (e.g., mapping), maintenance, or replacement of that device.

"Assistive technology service" means any service that directly assists in the selection, acquisition, or use of an assistive technology device. Assistive technology services include (i) evaluating the needs of the child, including a functional evaluation in the child's customary environment; (ii) purchasing, leasing, or otherwise providing for the acquisition of assistive technology devices; (iii) selecting, designing, fitting, customizing, adapting, applying, maintaining, repairing, or replacing assistive technology devices; (iv) coordinating and using other therapies, interventions, or services with assistive technology devices, such as those associated with existing education and rehabilitation plans and programs; (v) providing training or technical assistance to a child, or, if appropriate, that child's family; and (vi) providing training or technical assistance to professionals, including individuals providing education or rehabilitation services, or other individuals who provide services to or are otherwise substantially involved in the major life functions of the child.

"Atypical development" means one or more of the following conditions or responses: (i) atypical or questionable sensory-motor responses; (ii) atypical or questionable social-emotional development; (iii) atypical or questionable behaviors that interfere with the acquisition of developmental skills; or (iv) impaired social interaction and communication skills with restricted and repetitive behaviors.

"Audiology" means services that include (i) identifying children with auditory impairments, using at-risk criteria and appropriate audiologic screening techniques; (ii) determining the range, nature, and degree of hearing loss and communication functions by use of audiological evaluation procedures; (iii) referring children with auditory impairment for medical or other services necessary for habilitation or rehabilitation; (iv) providing auditory training, aural rehabilitation, speech reading and listening devices, orientation and training, and other services; (v) providing services for prevention of hearing loss; and (vi) determining the child's individual amplification, including selecting, fitting, and dispensing appropriate listening and vibrotactile devices, and evaluating the effectiveness of those devices.

"Child find" means a comprehensive and coordinated system to locate, identify, refer, and evaluate all children with disabilities in Virginia who may be eligible for early intervention services under Part C.

"Child with a disability" or "infant or toddler with a disability" means an individual who is under three years of age and who needs early intervention services because he is experiencing a developmental delay in one or more areas of development or atypical development or has a diagnosed physical or mental condition that has a high probability of resulting in developmental delay.

"Commissioner" means the Commissioner of the Department of Behavioral Health and Developmental Services.

"Counseling services" means the assessment and treatment of mental, emotional, or behavioral disorders and associated distresses that interfere with mental health, including (i) individual or family group counseling with the parent or parents and other family members; (ii) collaborating with the family, service coordinator, and other early intervention service providers identified on an infant's or toddler's individualized family service plan (IFSP); and (iii) family training, education, and support provided to assist the family of an infant or a toddler with a disability in understanding his needs related to development, behavior, or social-emotional functioning and to enhance his development.

"Day" means calendar day, unless clearly specified otherwise.

"Department" means the Department of Behavioral Health and Developmental Services.

"Developmental delay" means a level of functioning that (i) is at least 25% below the child's chronological or adjusted age in cognitive, physical, communication, social or emotional, or adaptive development or (ii) demonstrates atypical development or behavior even in the absence of a 25% delay. Developmental delay is measured using the evaluation and assessment procedures described in 12VAC35-225-90.

"Developmental services" means services provided to a child with a disability that include (i) designing learning environments and activities that promote the child's acquisition of skills in a variety of developmental areas, including cognitive processes and social interaction; (ii) curriculum planning, including the planned interaction of personnel, materials, time, and space, that leads to achieving the outcomes in the child's IFSP; (iii) providing families with information, skills, and support related to enhancing the skill development of the child; and (iv) working with the child to enhance his development.

"Discipline" or "profession" means a specific occupational category that may provide early intervention supports and services to eligible children under Part C and their families.

"Due process complaint" means a complaint filed by a parent requesting a due process hearing to resolve a disagreement with an early intervention service provider's proposal or refusal to initiate or change identification, eligibility determination, or placement of the child or the provision of early intervention services to the child or family.

"Duration" means the projection of when a given early intervention service will no longer be provided, such as when the child is expected to achieve the results or outcomes in his IFSP.

"Early intervention practitioner" means a person who is qualified to apply for or who holds certification as an early intervention professional, specialist, or case manager. An early intervention practitioner may be employed as an early intervention service provider under Part C.

"Early intervention records" means all records regarding a child that are required to be collected, maintained, or used under Part C.

"Early intervention service provider" means a provider agency, whether public, private, or nonprofit, or an early intervention practitioner that provides early intervention services under Part C, whether or not the agency or individual receives federal Part C funds.

"Early intervention services" means services provided through Part C designed to meet the developmental needs of children and families and to enhance the development of children from birth to age three years who have (i) a 25% developmental delay in one or more areas of development, (ii) atypical development, or (iii) a diagnosed physical or mental condition that has a high probability of resulting in a developmental delay. Early intervention services provided in the child's home and in accordance with this chapter shall not be construed to be home health services as referenced in § 32.1-162.7 of the Code of Virginia.

"Eligibility determination" means the evaluation procedures used by qualified early intervention service providers to determine a child's initial and continuing eligibility under Part C.

"Family fee" means the amount based on the accrued charges and copayments that may be charged to families for services that an infant or a toddler with a disability and his family receive each month. The family fee may not exceed the monthly cap.

"Frequency" means the number of days or sessions a service will be provided.

"Health services" means services necessary to enable a child receiving services under Part C to benefit from other early intervention supports and services he receives and includes (i) providing clean intermittent catheterization, tracheostomy care, tube feeding, the changing of dressings or colostomy collection bags, and other health services and (ii) arranging consultation by physicians with other service providers concerning the special health care needs of the child that will need to be addressed in the course of providing other early intervention services. The term does not include services that are surgical in nature (e.g., cleft palate surgery, surgery for club foot, or the shunting of hydrocephalus); purely medical in nature (e.g., hospitalization for management of congenital heart ailments or the prescribing of medicine or drugs for any purpose); or related to the implementation, optimization (e.g., mapping), maintenance, or replacement of a medical device that is surgically implanted, including a cochlear implant; devices (e.g., heart monitors, respirators and oxygen, and gastrointestinal feeding tubes and pumps) necessary to control or treat a medical condition; or medical health services (e.g., immunizations and regular "well-baby" care) that are routinely recommended for all children.

"Homeless children" means children who meet the definition given the term "homeless children and youths" in § 752 (42 USC § 11434a) of the McKinney-Vento Homeless Assistance Act, as amended, 42 USC § 11434a et seq.

"Inability to pay" means the amount a family is able to contribute toward the cost of early intervention services is zero, resulting in the family's receiving all early intervention services at no cost to the family.

"Indian" means an individual who is a member of an Indian tribe.

"Indian tribe" means any federal or state Indian tribe, band, rancheria, pueblo, colony, or community, including any Alaska native village or regional village corporation.

"Individualized family service plan" or "IFSP" means a written plan for providing early intervention supports and services to a child with a disability or his family that (i) is based on the evaluation for eligibility determination and assessment for service planning; (ii) includes information based on the child's evaluation and assessments, family information, results or outcomes, and supports and services based on peer-reviewed research (to the extent practicable) that are necessary to meet the unique needs of the child and the family and to achieve the results or outcomes; and (iii) is implemented as soon as possible once parental consent is obtained.

"Informed clinical opinion" means the use of professional expertise and experience in combination with information gathered through eligibility determination or assessment for service planning, or both, to determine the child's developmental status and eligibility under Part C.

"Initial early intervention service coordination plan" means a written plan that specifies the activities that will be completed by the service coordinator prior to completion of the individualized family service plan.

"Intensity" means whether a service will be provided on an individual or group basis.

"Length of service" means the amount of time the service will be provided during each session (e.g., an hour or other specified timeframe).

"Local lead agency" means an entity that, under contract with the department, administers a local early intervention system.

"Location of service" means the actual place or places where the early intervention service will be provided.

"Medical services" means services provided by a licensed physician for diagnostic or eligibility determination purposes to determine a child's developmental status and need for early intervention supports and services.

"Monthly cap" means the maximum amount that a family will be required to pay per month for early intervention services regardless of the charge or charges or number of different types, frequency, or length of services a child and family receive.

"Multidisciplinary" means the involvement of two or more separate disciplines or professions.

"Native language" means the language or mode of communication, such as sign language, Braille, or oral communication for persons with no written language, that is normally used by the child or his parents.

"Natural environments" means settings that are natural or typical for a same-aged child without a disability and may include the home or community settings.

"Nursing services" means services that include (i) conducting assessments of health status for the purpose of providing nursing care, including the identification of patterns of human response to actual or potential health problems; (ii) providing nursing care to prevent health problems, restore or improve functioning, and promote optimal health and development; and (iii) administering medications, treatment, and regimens prescribed by a licensed physician.

"Nutrition services" means services that include (i) individual assessments in nutritional history and dietary intake; anthropometric, biochemical, and clinical variables; feeding skills and feeding problems; and food habits and food preferences; (ii) developing and monitoring appropriate plans to address the nutritional needs of children eligible for early intervention supports and services based on the findings of individual assessments; and (iii) making referrals to appropriate community resources to carry out nutritional goals.

"Occupational therapy" means services that are designed to improve the child's functional ability to perform tasks in home, school, and community settings, and include (i) identifying and assessing the child's functional needs and providing interventions related to adaptive development; adaptive behavior; play; and sensory, motor, and postural development; (ii) adapting the environment and selecting, designing, and fabricating assistive and orthotic devices to facilitate development and promote the acquisition of functional skills; and (iii) preventing or minimizing the impact of initial or future impairment, delay in development, or loss of functional ability.

"Parent" means (i) a biological or adoptive parent of a child; (ii) a foster parent, unless state law, regulations, or contractual obligations with a state or local entity prohibit a foster parent from acting as a parent; (iii) a guardian generally authorized to act as the child's parent or authorized to make early intervention, educational, health, or developmental decisions for the child (but not the state if the child is a ward of the state); (iv) an individual acting in the place of a biological or adoptive parent, including a grandparent, stepparent, or other relative, with whom the child lives or an individual who is legally responsible for the child's welfare; or (v) a surrogate parent, when determined necessary in accordance with and assigned pursuant to this chapter. The term "parent" does not include any local or state agency or its agents if the child is in the custody of said agency.

"Part B" means Part B of the Individuals with Disabilities Education Act, 20 USC § 1411 et seq.

"Part C" means Part C of the Individuals with Disabilities Education Act, 20 USC § 1431 et seq.

"Participating agencies" means the Departments of Health, Education, Medical Assistance Services, Behavioral Health and Developmental Services, and Social Services; the Departments for the Deaf and Hard-of-Hearing and Blind and Vision Impaired; and the Bureau of Insurance within the State Corporation Commission.

"Payor of last resort" means a funding source that may be used only after all other available public and private funding sources have been accessed.

"Personally identifiable information" means the name of the child, the child's parent, or other family members; the address of the child or the child's family; a personal identifier, such as the child's or parent's social security number; or a list of personal characteristics or other information that, alone or in combination, could be used to identify the child or the child's parents or other family members.

"Physical therapy" means services that promote the child's sensory or motor function and enhance his musculoskeletal status, neurobehavioral organization, perceptual and motor development, cardiopulmonary status, and effective environmental adaptation. These services include (i) screening, evaluation for eligibility determination, and assessment of children to identify movement dysfunction; (ii) obtaining, interpreting, and integrating information appropriate to program planning to prevent, alleviate, or compensate for movement dysfunction and related functional problems; (iii) adapting the environment and selecting, designing, and fabricating assistive and orthotic devices to facilitate development and promote the acquisition of functional skills; and (iv) providing individual or group services or treatment to prevent, alleviate, or compensate for movement dysfunction and related functional problems.

"Primary referral sources" means those agencies, providers, entities, and persons who refer children and their families to the early intervention system and include (i) hospitals, including prenatal and postnatal care facilities; (ii) physicians; (iii) parents; (iv) child care programs and early learning programs; (v) local school divisions; (vi) public health facilities; (vii) other public health or social service agencies; (viii) other clinics and health care providers; (ix) public agencies and staff in the child welfare system, including child protective services and foster care; (x) homeless family shelters; and (xi) domestic violence shelters and agencies.

"Psychological services" means services that include (i) administering psychological and developmental tests and other assessment procedures; (ii) interpreting assessment results; (iii) obtaining, integrating, and interpreting information about child behavior and child and family conditions related to learning, mental health, and development; and (iv) planning and managing a program of psychological services, including psychological counseling for children and parents, family counseling, consultation on child development, parent training, and education programs.

"Service coordinator" means a person who holds a certification as an early intervention case manager and is responsible for assisting and enabling children with disabilities and their families to receive the services and rights, including procedural safeguards, that are authorized to be provided under Virginia's early intervention program.

"Sign language and cued language services" means (i) teaching sign language, cued language, and auditory or oral language; (ii) providing oral transliteration services, such as amplification; and (iii) providing sign and cued language interpretation.

"Single point of entry" means the single entity designated by the local lead agency in each local early intervention system where families and primary referral sources make initial contact with the local early intervention system.

"Social work services" means services that include (i) making home visits to evaluate a child's living conditions and patterns of parent-child interaction; (ii) preparing a social or emotional developmental assessment of the child within the family context; (iii) providing individual and family-group counseling with parents and other family members, including appropriate social skill-building activities with the child and parents; (iv) working with identified problems in the living situation (home, community, and any center where early intervention supports and services are provided) that affect the child's use of early intervention supports and services; and (v) identifying, mobilizing, and coordinating community resources and services to enable the child with a disability and his family to receive maximum benefit from early intervention services.

"Speech-language pathology services" means services that include (i) identifying children with communication or language disorders and delays in development of communication skills and identifying and appraising specific disorders and delays in those skills; (ii) referring children with communication or language disorders and delays in development of communication skills for medical or other professional services necessary for the habilitation or rehabilitation; and(iii) providing services for the habilitation, rehabilitation, or prevention of communication or language disorders and delays in development of communication skills.

"State lead agency" means DBHDS, which is the agency designated by the Governor to receive funds to administer the state's responsibilities under Part C.

"Surrogate parent" means a person assigned by the local lead agency or its designee to ensure that the rights of a child are protected when no parent can be identified; the lead agency or other public agency, after reasonable efforts, cannot locate a parent; or the child is a ward of the state.

"Transportation and related costs" means the cost of travel and other costs that are necessary to enable a child with a disability and his family to receive early intervention supports and services.

"Virginia Interagency Coordinating Council" or "VICC" means the advisory council, established pursuant to § 2.2-2664 of the Code of Virginia, to promote and coordinate Virginia's system of early intervention services.

"Vision services" means services that include (i) evaluating and assessing visual functioning, including the diagnosis and appraisal of specific visual disorders, delays, and abilities that affect early childhood development; (ii) referring for medical or other professional services necessary for the habilitation or rehabilitation of visual functioning disorders, or both; and (iii) providing communication skills training, orientation and mobility training for all environments, visual training, and additional training necessary to activate visual motor abilities.

"Visit" means a face-to-face encounter with (i) the child with a disability or (ii) his parent, another family member, or caregiver, or both, for the purpose of providing early intervention supports and services.

"Ward of the state" means a child who, as determined by Virginia, is a foster child or is in the custody of a public children's residential facility. The term does not include a foster child who has a foster parent who meets the definition of "parent."

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

Part II Virginia Early Intervention Services System

12VAC35-225-30 Early intervention services applicability, availability, and coordination

A. This chapter shall apply to state and local lead agencies, early intervention practitioners, and provider agencies.

B. Appropriate early intervention services based on scientifically based research, to the extent practicable, shall be available to all children with disabilities who are eligible for early intervention services in Virginia and their families, including (i) children and families who reside on an Indian reservation geographically located in Virginia or who are homeless and (ii) children who are wards of the state.

C. The Virginia Interagency Coordinating Council (VICC) shall promote and coordinate early intervention services in the Commonwealth and shall advise and assist the department.

1. Nonstate agency members of the VICC shall be appointed by the Governor. State agency representatives shall be appointed by their agency directors or commissioners.

2. The VICC membership shall reasonably represent the population and shall be composed as follows:

a. At least 20% shall be parents, including minority parents, of infants or toddlers with disabilities or children with disabilities aged 12 years or younger, with knowledge of, or experience with, programs for children with disabilities. At least one parent member shall be a parent of a child with a disability aged six years or younger;

b. At least 20% shall be public or private providers of early intervention services;

c. At least one member shall be from the Virginia General Assembly;

d. At least one member shall be involved in personnel preparation;

e. At least one member shall be from each of the participating agencies involved in the provision of or payment for early intervention services to children with disabilities and their families. These members shall have sufficient authority to engage in policy planning and implementation on behalf of the participating agency and shall include:

(1) At least one member from the Department of Education, the state educational agency responsible for preschool services to children with disabilities. This member shall have sufficient authority to engage in policy planning and implementation on behalf of the Department of Education;

(2) At least one member from the Department of Medical Assistance Services, the agency responsible for the state Medicaid program;

(3) At least one member from the Department of Social Services, the agency responsible for child care and foster care;

(4) At least one member from the State Corporation Commission, Bureau of Insurance, the agency responsible for regulating private health insurance;

(5) At least one member designated by the Office of the Coordination of Education of Homeless Children and Youth;

(6) At least one member from the Department of Behavioral Health and Developmental Services, the agency responsible for children's mental health;

(7) At least one member from the Department for the Blind and Vision Impaired;

(8) At least one member from the Department for the Deaf and Hard of Hearing; and

(9) At least one member from the Department of Health;

f. At least one member shall be from the Children's Health Insurance Program (CHIP) of Virginia;

g. At least one member shall be from a Head Start or Early Head Start agency or program in Virginia; and

h. Other members selected by the Governor.

3. The VICC shall operate as follows:

a. The VICC shall have bylaws that outline (i) nomination processes and roles of officers and committees and (ii) other operational procedures;

b. No member of the VICC shall cast a vote on any matter that would provide direct financial benefit to that member or otherwise give the appearance of a conflict of interest under Virginia law;

c. The VICC shall meet, at a minimum, on a quarterly basis;

d. VICC meetings shall be announced in advance in the Commonwealth Calendar and through an announcement to local lead agencies; and

e. VICC meetings shall be open and accessible to the public, and each meeting shall include a public comment period. Interpreters for persons who are deaf and other necessary services for both VICC members and participants shall be provided as necessary and upon request.

4. Subject to approval by the Governor, the VICC shall work with the department to develop an annual budget for VICC expenses that may include the use of Part C funds for the following:

a. Conducting hearings and forums;

b. Reimbursing members of the VICC for reasonable and necessary expenses for attending VICC meetings and performing VICC duties, including child care for parent representatives;

c. Compensating a member of the VICC if the member is not employed or must forfeit wages from other employment when performing official VICC business;

d. Hiring staff; and

e. Obtaining the services of professional, technical, and clerical personnel as may be necessary to carry out its functions under Part C.

5. Except as provided in subdivision 4 e of this subsection, VICC members shall serve without compensation from funds available under Part C.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

Part III Referrals for Early Intervention Services and Supports

12VAC35-225-40 Public awareness and child identification and referral

A. The department shall develop and implement a public awareness program that focuses on the early identification of infants and toddlers with disabilities and provides information to parents of infants and toddlers through primary referral sources.

B. Local lead agencies and early intervention service providers shall collaborate with the department to prepare and disseminate information to all primary referral sources, including a description of the early intervention services available, a description of the child find system and how to refer a child under the age of three years for eligibility determination or early intervention services, and a central directory.

C. The department, local lead agencies, and early intervention service providers shall collaborate with and assist primary referral sources in disseminating the information in subsection B of this section to parents of infants and toddlers, especially parents with premature infants or infants with other physical risk factors associated with learning or developmental complications.

D. Local lead agencies shall develop and implement local public awareness and child find procedures that include the methods to be used for planning and distributing public awareness materials and the roles of agencies and persons in the community involved in public awareness and child find activities.

E. The department shall maintain a central directory that shall be accessible to the general public through a toll-free number and the Internet. The central directory shall include accurate and up-to-date information about:

1. Public and private early intervention services, resources, and experts available in Virginia;

2. Professional and other groups (including parent support and training and information centers) that provide assistance to children with disabilities and their families; and

3. Research and demonstration projects being conducted in Virginia relating to children with disabilities.

F. The department shall implement a comprehensive child find system that is consistent with Part B of the Individuals with Disabilities Education Act, 20 USC § 1411 et seq., and ensures that all children with disabilities who are eligible for early intervention services in Virginia are identified, located, and evaluated for eligibility determination, including:

1. Indian children with disabilities residing on a reservation geographically located in Virginia, including coordination, as necessary, with tribes, tribal organizations, and consortia;

2. Children with disabilities who are homeless, in foster care, and wards of the state;

3. Children who are the subject of a substantiated case of child abuse or neglect; and

4. Children who are identified as directly affected by illegal substance abuse or withdrawal symptoms resulting from prenatal drug exposure.

G. The department shall ensure that the child find system is coordinated with all other major efforts to locate and identify children by other state agencies responsible for administering the various education, health, and social service programs relevant to children with disabilities and their families, including Indian tribes, and with the efforts of the:

1. Preschool special education program through the Department of Education;

2. Maternal and Child Health program, including the Maternal, Infant, and Early Childhood Home Visiting Program (42 USC § 711) under Title V of the Social Security Act;

3. Early Periodic Screening, Diagnosis and Treatment (EPSDT) program under Title XIX (42 USC § 1396 et seq.) of the Social Security Act;

4. Programs under the Developmental Disabilities Assistance and Bill of Rights Act of 2000 (42 USC § 15001 et seq.);

5. Head Start and Early Head Start programs;

6. Supplemental Security Income program under Title XVI (42 USC § 1381 et seq.) of the Social Security Act;

7. Child protection and child welfare programs, including programs administered by, and services provided through, the Department of Social Services, as the foster care agency and as the state agency responsible for administering the Child Abuse Prevention and Treatment Act (CAPTA) (42 USC § 5101 et seq.);

8. Child care programs in Virginia;

9. Programs that provide services under the Family Violence Prevention and Services Act (42 USC § 10401 et seq.);

10. Virginia's Early Hearing Detection and Intervention (EHDI) system;

11. Children's Health Insurance Program (CHIP) authorized under Title XXI (42 USC § 1397aa et seq.) of the Social Security Act;

12. Virginia Newborn Screening Program;

13. Virginia Congenital Anomalies Reporting Education System (VACARES); and

14. Care Connection of Virginia.

H. The department and local lead agencies shall use interagency agreements, memoranda of understanding, or other mechanisms, as needed, to minimize duplication of child find efforts among the programs listed in subsection G of this section and to ensure that there will be effective use of the resources available through each public agency and early intervention service providers in Virginia to implement the child find system.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-50 Referrals to the single point of entry

A. All local lead agencies shall identify a single point of entry in their respective local early intervention systems to receive all referrals and inquiries from families and primary referral sources. This single point of entry shall be published in local public awareness and child find materials and communicated to potential referral sources.

B. Primary referral sources shall refer to the single point of entry any infant or toddler potentially eligible for early intervention services as soon as possible, but in no case more than seven days, after the child has been identified as potentially eligible.

C. The department shall require that local community services boards responsible for implementing and managing discharge plans required by § 32.1-127 B 6 of the Code of Virginia for substance-abusing postpartum women and their infants refer to the single point of entry any child under the age of three years who is identified as affected by illegal substance abuse or withdrawal symptoms resulting from prenatal drug exposure.

D. The Department of Social Services shall refer to the single point of entry any child under the age of three years who is:

1. Identified as affected by illegal substance abuse or withdrawal symptoms resulting from prenatal drug exposure, or

2. The subject of a founded disposition of child abuse or neglect.

E. Early intervention service providers shall refer to the single point of entry any infant or toddler potentially eligible for early intervention services who becomes known to the provider through any source other than the early intervention system.

F. Parental consent shall not be required in order to make a referral to the local early intervention system, and the local system shall accept a referral even if the referral source has not informed the family of the referral.

G. Referrals to the local single point of entry may be made by phone, fax, mail, email, or web-based system; in writing; or in person.

H. When making a referral, the referral source shall provide, at minimum, the child's or a family member's name and one method of contacting the family.

I. The date on which the local single point of entry receives a referral shall be counted as the first day of the 45-day timeline specified in 12VAC35-225-80 C within which eligibility determination, assessment for service planning, and the initial IFSP meeting shall be completed.

J. The single point of entry shall inform referred families whose children are close to the age of eligibility for early childhood special education services through the local school division under Part B that they have the option to be referred to the local school division instead of or simultaneously with referral to early intervention under Part C.

K. Upon referral, the single point of entry shall begin an early intervention record for the child and assign a service coordinator who will assist the family with intake, eligibility determination, and, if eligible, assessment for service planning and development of an IFSP.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

Part IV Intake, Eligibility, and Assessment

12VAC35-225-60 Intake

A. For purposes of the early intervention system, including determination of required parental consents or exercise of parental rights, when more than one party is qualified under the definition of parent, the biological or adoptive parent must be presumed to be the parent unless that person does not have legal authority to make educational or early intervention decisions for the child. However, if a judicial decree or order identifies a specific person or persons to act as the parent of a child or to make educational or early intervention decisions on behalf of a child, then that person or persons shall be determined to be the parent.

B. The service coordinator shall conduct intake with the family in order to:

1. Inform the family about early intervention services and the IFSP process;

2. Provide the parent with a written notice and explanation of the family's rights and procedural safeguards under Part C, including:

a. A description of what personally identifiable information is maintained, the types of information sought, the methods used in gathering information, including the sources from whom information is gathered, and the uses to be made of the information;

b. The policies that early intervention service providers must follow regarding storage, disclosure to third parties, retention, and destruction of personally identifiable information;

c. The rights of parents and children regarding the foregoing information, including their rights under the confidentiality provisions of Part C; and

d. A description of the languages in which this notice of rights and safeguards is available in Virginia;

3. With prior written notice and parental consent, gather information about the child's development and health history to assist in eligibility determination;

4. Facilitate identification of team members for and coordinate scheduling of eligibility determination;

5. Provide the schedule of sliding fees for early intervention services provided under Part C and other payment information; and

6. For children with Medicaid, ensure completion of the paperwork, including development of an Initial Early Intervention Service Coordination Plan and data entry necessary to enroll the child in the Medicaid early intervention benefit. This plan shall end when the child is found ineligible for early intervention; the IFSP is signed; or 90 calendar days from the date of intake, whichever comes first.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-70 Eligibility criteria

A. The department shall identify physical and mental conditions with high probability of resulting in developmental delay.

B. A child shall be eligible for early intervention services under Part C if the child is younger than three years of age and has:

1. A developmental delay as measured through the evaluation and assessment procedures described in this section; or

2. A diagnosed physical or mental condition with high probability of resulting in developmental delay.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-80 Evaluation for eligibility criteria

A. A child's medical and other records shall be used to establish initial eligibility (without conducting an evaluation for eligibility determination) if those records indicate that the child's level of functioning in one or more developmental areas constitutes a developmental delay or that the child otherwise meets the criteria for an infant or a toddler with a disability.

1. If the records document a diagnosed physical or mental condition with a high probability of resulting in developmental delay, then a certified early intervention case manager or certified early intervention professional shall complete and sign the eligibility determination form to document review of the record.

2. If the records document a developmental delay, a certified early intervention professional shall review the record to determine whether it establishes eligibility, completing and signing the eligibility determination form if it does.

B. With prior written notice and parental consent, each child under the age of three years who is referred to the early intervention system shall receive a timely, comprehensive multidisciplinary evaluation to determine eligibility unless eligibility is established under subsection A of this section.

C. Except as provided in subsection A of this section, the local lead agency shall ensure that, with parental consent, the evaluation for eligibility determination and, if the child is eligible, an assessment of the child and family and an initial IFSP meeting are completed within 45 days from the date of referral.

D. The 45-day timeline described in subsection C of this section shall not apply for any period when:

1. The child or parent is unavailable to complete the evaluation for eligibility determination, the assessments of the child and family, or the initial IFSP meeting due to exceptional family circumstances that are documented in the child's early intervention record; or

2. The parent has not provided consent for the evaluation for eligibility determination or the assessment of the child despite documented, repeated attempts by the service coordinator or other service provider, or both, to obtain parental consent.

E. In the event that circumstances described in subsection D of this section delay the 45-day timeline, the service coordinator shall ensure:

1. The exceptional family circumstances, repeated attempts to obtain parental consent, or other circumstances resulting in a delay are documented in the child's early intervention record;

2. The evaluation for eligibility determination, the assessments of the child and family, and the initial IFSP meeting are completed as soon as possible after the documented exceptional family circumstances no longer exist, parental consent is obtained, or other circumstances causing a delay no longer exist; and

3. Development of an interim IFSP, if appropriate for the child and family.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-90 Eligibility determination process

A. Eligibility determination shall be conducted by a multidisciplinary team of certified early intervention professionals, which may include one individual who is certified as an early intervention practitioner in more than one discipline or profession, and shall include the use of informed clinical opinion.

B. Eligibility determination shall be conducted in a nondiscriminatory manner and with procedures selected that are not racially, culturally, or linguistically discriminatory.

C. Eligibility determination shall be conducted in the native language of the parent or other mode of communication used by the parent unless the early intervention service providers conducting the evaluation of the child determine that the language normally used by the child is developmentally appropriate for the child.

D. No single procedure shall be used as the sole criterion for determining a child's eligibility.

E. Eligibility determination shall include:

1. Use of an evaluation instrument;

2. Taking the child's history, including interviewing the parent;

3. Identifying the child's level of functioning in cognitive, physical, communication, social or emotional, and adaptive development;

4. Gathering information from other sources such as family members, other caregivers, medical providers, social workers, and educators, if necessary, to understand the full scope of the child's unique strengths and needs; and

5. Reviewing medical, educational, or other records.

F. Informed clinical opinion may be used as an independent basis to establish a child's eligibility even when other instruments do not establish eligibility; however, in no event may informed clinical opinion be used to negate the results of instruments used to establish eligibility.

G. The eligibility determination date, methods, participants, and results shall be documented on the eligibility determination form.

H. The service coordinator shall provide the family with a copy and explanation of the eligibility determination form as soon as possible following eligibility determination at no cost to the family.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-100 Ineligibility for early intervention services

If, through the process of eligibility determination, a child is found to be not eligible for early intervention services, the service coordinator shall provide the parent with:

1. A prior written notice that the child has been determined to be not eligible, and

2. A copy and explanation of the notice of child and family rights and safeguards including the parent's right to dispute the eligibility determination by any combination of requesting mediation, making a due process complaint, or filing an administrative complaint.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-110 Assessment for service planning

A. With prior written notice and parental consent, each child found eligible for early intervention services shall receive:

1. A multidisciplinary assessment of the child's unique strengths and needs and the identification of services appropriate to meet those needs; and

2. A family-directed assessment of the resources, priorities, and concerns of the family and identification of the supports and services necessary to enhance the family's capacity to meet the developmental needs of that infant or toddler.

B. Assessments for service planning shall be conducted by a multidisciplinary team of certified early intervention professionals, which may include one individual who is certified as an early intervention practitioner in more than one discipline or profession, and shall include the use of informed clinical opinion.

C. Assessments shall be conducted in a nondiscriminatory manner and with procedures selected that are not racially, culturally, or linguistically discriminatory.

D. Assessments shall be conducted in the native language of the parent or other mode of communication used by the parent unless the early intervention service providers conducting the assessment of the child determine that the language normally used by the child is developmentally appropriate for the child.

E. The multidisciplinary assessment of the child shall include:

1. A review of the results of the eligibility determination;

2. Use of a comprehensive assessment tool;

3. Personal observations of the child;

4. Identification of the child's needs in cognitive, physical, communication, social or emotional, and adaptive development; and

5. If the child is new to Virginia's early intervention system, determination of entry ratings on the child outcome indicators required by the U.S. Department of Education, Office of Special Education Programs.

F. The initial family assessment shall be conducted within 45 days from the date of referral if the parent concurs, even if other family members are not available. The family-directed assessment shall:

1. Be voluntary on the part of each family member participating in the assessment;

2. Be based on information obtained through an assessment tool and through an interview with those family members who elect to participate in the assessment;

3. Include the family's description of its resources, priorities, and concerns related to enhancing their child's development; and

4. Be conducted in the native language or other mode of communication used by the family member participating in the assessment, unless clearly not feasible to do so.

G. Early intervention service providers conducting assessments shall document the assessment results in the integrated, comprehensive assessment summary on the IFSP or in a separate written report that is then integrated into the comprehensive assessment summary on the IFSP.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

Part V Service Planning, Delivery, Transition, and Discharge

12VAC35-225-120 Individualized family service plan (IFSP) development

A. A written IFSP shall be developed and implemented, with parental consent, for each eligible child.

B. The IFSP shall include:

1. The child's name, date of birth, gender, and city or county of residence; IFSP date and the dates the six-month IFSP review is due and dates reviews are completed; child's and family's primary language or mode of communication; parents' and, if requested by the family, other family members' contact information; and the service coordinator's name and contact information;

2. Information about the child's and family's daily routines and activities;

3. The child's present levels of physical, including vision, hearing, motor, and health status, cognitive, communication, social or emotional, and adaptive development based on the information from eligibility determination and assessment for service planning;

4. With the concurrence of the family, a statement of the family's resources, priorities, and concerns related to enhancing the development of the child;

5. The measurable outcomes to be achieved for the child, including preliteracy and language skills, as developmentally appropriate for the child, and the criteria, procedures, and timelines for determining the degree to which progress toward meeting the outcomes is being made and whether revisions to the outcomes or early intervention services identified in the IFSP are necessary;

6. The specific early intervention services, based on peer-reviewed research (to the extent practicable), that are needed to meet the unique needs of the child and family and to achieve the identified outcomes including:

a. Assistive technology devices and assistive technology services;

b. Audiology services;

c. Developmental services;

d. Counseling services;

e. Family training services;

f. Health services;

g. Medical services;

h. Nursing services;

i. Nutrition services;

j. Occupational therapy;

k. Physical therapy;

l. Psychological services;

m. Service coordination services;

n. Sign language and cued language services;

o. Social work services;

p. Speech-language pathology services;

q. Transportation services and related costs;

r. Vision services; or

s. Other services, as identified by the IFSP team;

7. The length, duration, frequency, intensity, method, and location of service for each service;

8. A statement of the natural environment in which each early intervention service will be provided or a justification made by the IFSP team, including the parent, as to why, based on the child's outcomes, the service cannot be provided in the natural environment;

9. Payment arrangements, if any;

10. To the extent appropriate, the medical and other services that the child or family needs or is receiving through other sources, but that are neither required nor funded under Part C and the steps the service coordinator or family may take to assist the child and family in securing those other services if those services are not currently being provided;

11. The projected date for the initiation of each early intervention service identified in the IFSP, which shall be as soon as possible but no more than 30 days from the date the parent signs the IFSP unless the IFSP team agrees on a later start date in order to meet the needs of the child or family;

12. The name of the service coordinator who will be responsible for implementing the early intervention services identified in the IFSP; and

13. The steps and services to be taken to support the smooth transition of the child from early intervention services to preschool services under Part B or other appropriate services, if any. The transition steps in the IFSP shall include, but are not limited to, the following:

a. Discussions with, and training of, parents, as appropriate, regarding future placements and other matters related to the child's transition;

b. Procedures to prepare the child for changes in service delivery, including steps to help the child adjust to, and function in, a new setting;

c. Confirmation that the required notification, unless the parent disagrees, and with parental consent additional information, such as copies of evaluations and assessments and the most recent IFSP, needed by the local school division to ensure continuity of services have been sent to the local school division; and

d. Identification of transition services and other activities that the IFSP team determines are necessary to support the transition of the child.

C. A meeting to develop the initial IFSP shall be held within 45 days from the date the referral is received.

D. Meetings of the multidisciplinary IFSP team, which must include two or more certified early intervention practitioners from separate disciplines or professions, shall include the following participants:

1. The parent or parents of the child;

2. Other family members, as requested by the parent, if feasible to do so;

3. An advocate or person outside of the family if the parent requests that the person participate;

4. The service coordinator who will be responsible for implementing the IFSP;

5. A person or persons directly involved in conducting eligibility determination, assessment for service planning, or both; and

6. As appropriate, persons who will be providing early intervention services to the child or family.

E. Each meeting to develop an IFSP shall:

1. Take place in a setting and at a time that is convenient to the family; and

2. Be conducted in the native language of the family or other mode of communication used by the family, unless it is clearly not feasible to do so.

F. If an IFSP team member is unable to attend an IFSP meeting, the service coordinator shall make arrangements for the person's involvement through other means, which may include participating by telephone, having a knowledgeable authorized representative attend the meeting, or submitting a written report.

G. The service coordinator shall provide prior written notice of the date, time, and location of the IFSP meeting to the family and other participants early enough before the IFSP meeting date to ensure that they will be able to attend.

H. The service coordinator shall assist the parent in preparing for the IFSP meeting and shall ensure that the parent has the information needed in order to fully participate in the meeting.

I. With parental consent, an interim IFSP shall be developed and implemented when an eligible child or the child's family has an immediate need for early intervention services prior to completion of eligibility determination and assessment for service planning.

1. The interim IFSP shall include the name of the service coordinator who will be responsible for implementing the interim IFSP and coordinating with other agencies and persons; the early intervention services that have been determined to be needed immediately, including the frequency, intensity, length, location, and methods of delivery; and the parent's signature indicating consent to implement the interim IFSP.

2. The development of an interim IFSP shall not negate the requirement to complete the eligibility determination and assessment for service planning and develop an initial IFSP within 45 calendar days of referral.

J. The service coordinator shall document in a contact note any circumstances that result in eligibility determination, assessment for service planning, or initial IFSP development occurring more than 45 calendar days after referral.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-130 IFSP approval and selection of service providers

A. The service coordinator shall explain the contents of the IFSP to the parent, and informed written consent shall be obtained as indicated by the parent's signature and date of signature on the IFSP prior to the provision of early intervention services.

B. The service coordinator shall assist the family in selecting a service provider for each early intervention service listed on the IFSP from among those provider agencies, including independent providers, that are qualified to provide the services identified on the IFSP, that are in the parent's payor network, and that practice in the area where the child and family live. The parent's choice of service providers shall be documented on the IFSP addendum page, which shall be signed and dated by the parent prior to service delivery.

1. If no early intervention service provider that can support and assist the family in accomplishing the IFSP outcomes is available within the family's Medicaid or private insurance network, then the parent shall be able to choose an early intervention service provider from outside the parent's third party payor network.

2. If there is only one provider agency for the service needed by the child and family, then the parent shall be offered a choice of early intervention service providers from within that one provider agency for services other than service coordination. If the parent elects not to receive services from the one provider agency, then the local lead agency shall work to identify an alternative early intervention service provider.

3. The parent shall be offered the opportunity to select a provider agency any time a new service is added or when a change in provider agency is needed.

4. If the selected provider agency is unable to provide the service due to full provider caseloads or the requested early intervention service provider within that provider agency is unavailable, then the service coordinator shall explain to the parent the option to begin services right away with an available provider or to wait for his chosen provider to become available. If the parent chooses to wait, the service coordinator shall document the parent's decision in a contact note, the parent's consent to the IFSP service shall begin once the parent's specific provider is available, and services shall be provided in a timely manner following parental consent.

5. The service coordinator shall inform the parent that he may request to change his service provider at any time by contacting the service coordinator.

C. The service coordinator shall retain a signed copy of the IFSP and, as soon as possible following development of the IFSP, shall provide a copy to the parent at no cost to the family and to all service providers that participated in assessment or development of the IFSP or will be implementing the IFSP.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-140 IFSP periodic review and updates

A. A periodic IFSP review shall be conducted every six months or any time the parent, service coordinator, or another member of the IFSP team identifies the potential need for revisions to the IFSP outcomes or services.

B. Each periodic IFSP review shall provide for the participation of the IFSP team members listed in 12VAC35-225-120 D 1 through D 4. If conditions warrant, provisions must be made for the participation of other representatives identified in 12VAC35-225-120 D.

C. Each periodic IFSP review shall include a determination of the degree to which progress has been made toward achieving the outcomes identified in the IFSP and the need for revisions of the outcomes or early intervention services identified in the IFSP.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-150 Annual IFSP review

A. An annual IFSP review shall be conducted to evaluate and revise, as appropriate, the IFSP for each child and the child's family.

B. The annual IFSP review shall include a determination of the child's continuing eligibility to receive early intervention services.

1. If the child's records document a diagnosed physical or mental condition with a high probability of resulting in developmental delay, then a service coordinator or certified early intervention professional shall complete and sign the eligibility determination form to document review of the record.

2. If the child's records document a developmental delay based on ongoing assessment, then a certified early intervention professional shall review the record to determine whether it establishes eligibility and shall complete and sign the eligibility determination form if it does.

3. In all other circumstances, a multidisciplinary team shall review existing health and developmental information gathered through records, parent input, observation, and an evaluation tool, if needed, to determine the child's continuing eligibility. The child's continuing eligibility determination date, methods, participants, and results shall be documented on the eligibility determination form.

4. The service coordinator shall provide the family, at no cost, with a copy and explanation of the eligibility determination form as soon as possible following the eligibility determination.

C. Each annual IFSP review shall be conducted by the child's multidisciplinary team that includes the team members listed in 12VAC35-225-120 D.

D. During the annual IFSP review, the results of any current evaluations and assessments of the child and family shall be used in determining the early intervention services that are needed and will be provided.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-160 Physician certification

A. Physician certification shall be required regarding the medical necessity for services if the child (i) is covered by public health insurance (Medicaid, FAMIS, or TRICARE) or by private health insurance that requires such certification and (ii) will receive services that can be reimbursed under that insurance plan. Certification shall be obtained at the initial and annual IFSP and any time a service is added or the frequency of a service is changed through a periodic IFSP review.

B. The service coordinator shall obtain a written certification of medical necessity from a physician (or physician assistant or nurse practitioner). A written certification requires:

1. A signature on the IFSP;

2. A signed letter referencing the IFSP; or

3. A completed and signed IFSP summary letter.

C. The service coordinator shall ensure that the certification required by this section certifies the IFSP as a whole. Early intervention service providers shall not be permitted to seek physician certification for individual services.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-170 Service delivery

A. Each early intervention service listed on a child's IFSP shall begin as soon as possible but no more than 30 days from the date the parent signs the IFSP unless the IFSP team decides on and documents the reasons for a later start date to meet the individual needs of the child and family. The 30-day timeline does not apply to delivery of an assistive technology device, which must be secured as soon as possible after the parent signs the IFSP.

B. Early intervention supports and services shall be provided only by certified early intervention service practitioners.

C. The service coordinator shall be responsible for the following:

1. Assisting parents of children with disabilities in obtaining access to needed early intervention services and other services identified in the IFSP, including making referrals to providers for needed services and scheduling appointments for children and their families;

2. Coordinating the provision of early intervention services and other services, such as educational, social, and medical services that are not provided for diagnostic or evaluative purposes, that the child needs or are being provided;

3. Conducting referral and other activities to assist families in identifying available early intervention service providers;

4. Coordinating, facilitating, and monitoring delivery of early intervention services required to ensure the services are provided in a timely manner;

5. Conducting follow-up activities to determine that appropriate early intervention services are being provided;

6. If the child has Medicaid or FAMIS:

a. Documenting in a contact note the family's preferred method of contact (i.e., face-to-face, phone, email, or text) for the family contacts that are required every three months and any change in the family's preferred method of contact;

b. Making at least one direct contact with the family every three calendar months, beginning no later than the month after the initial IFSP is signed, with the method of contact determined by the family; and

c. Requesting completion of a health status report by the child's physician every six months.

D. Early intervention service providers shall deliver services in accordance with the IFSP and make a good faith effort to assist each eligible child in achieving the outcomes in the child's IFSP.

E. Early intervention sessions canceled by the provider or missed due to a holiday shall be made up as quickly as possible unless the parent declines a make-up session.

F. Parents may request to change their early intervention service provider at any time by notifying their service coordinator.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-180 Service documentation

A. Early intervention service providers shall document all contacts made and all activities completed with or on behalf of families in a contact note within five business days of the contact. All contact notes shall include:

1. The child's first and last names;

2. Type of early intervention service provided;

3. Method of contact;

4. Date of the note and date of the contact if the note is not written on the same date; and

5. The early intervention provider's signature, with a minimum of first initial and last name, discipline and credentials of the provider, and the date the note is signed by the provider.

B. Contact notes that document a service session also shall include:

1. A narrative description of what occurred during the session including what was done; what the family or other caregiver did during the session, including how they actively participated during the session; how the child responded during the session, including what the child was able to do in relation to outcomes and goals; and suggestions for follow-up;

2. Who was present;

3. Length of session (in minutes);

4. Location or setting in which service was provided;

5. Information from the family about what has happened since the last session; and

6. Plan for the next contact.

C. Contact notes that document a service coordination contact or activity also shall include the length of the contact or activity (in minutes), the service coordination short-term goal that the contact activity is addressing, and progress toward achieving the service coordination goal.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-190 Transition

A. A child shall be considered potentially eligible for preschool services under Part B unless there is a clear expectation that the child will no longer require services by the time he reaches age three years. The determination of whether a particular child receiving early intervention services is potentially eligible for Part B shall be made by that child's IFSP team as part of the transition process.

B. The department shall ensure the parent of a child with disabilities is informed of the availability of services under § 619 of the Individuals with Disabilities Education Act not fewer than 90 days prior to the toddler's third birthday.

C. For each child who is potentially eligible for preschool services under Part B, and unless the parent objects, the service coordinator shall ensure notification to the local school division and the Virginia Department of Education not fewer than 90 days before the child's third birthday or the anticipated date of transition if the child is age two years by September 30 of a given school year.

1. The notification shall include the child's name, date of birth, and parental contact information including the parents' names, addresses, and telephone numbers.

2. The parent shall be informed in writing, on the IFSP, of the information that will be included in the notification, the earliest date on which the notification will be sent to the local school division and the Virginia Department of Education, and his right to opt out of the notification by initialing the opt out statement on the IFSP.

3. If the parent opts out of the notification, the notification shall not be sent.

D. If a child is potentially eligible for preschool services under Part B, the service coordinator shall, with the approval of the child's family, convene a transition conference among the local early intervention system, the family, and the local school division at least 90 days and (at the discretion of all parties) up to nine months before the child's third birthday, or anticipated date of transition if the child is age two years by September 30 of a given school year, to discuss any services the child may receive under Part B.

E. If a child is not potentially eligible for preschool services under Part B, the service coordinator shall, with the approval of the family, make a reasonable effort to convene a transition conference among the local early intervention system, the family, and providers of other appropriate services, as available, to discuss appropriate services that the child may receive.

F. The service coordinator shall ensure development of a transition plan in the IFSP at least 90 days and (at the discretion of all parties) up to nine months before the child's third birthday, or anticipated date of transition if the child is age two years by September 30 of a given school year, for all children exiting early intervention.

1. The family shall be included in the development of the transition plan.

2. The transition plan shall include steps for the child to exit the early intervention system and any transition services that the IFSP team identifies as needed by that child and family.

3. The service coordinator shall review with the parent the program options for a child with a disability for the period from his third birthday through the remainder of the school year.

G. The meeting to develop the transition plan and the transition conference may be combined.

H. The meeting to develop the transition plan and the transition conference, whether combined or held separately, shall meet the requirements of an IFSP meeting in 12VAC35-225-120.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-200 Referral and discharge

A. The service coordinator shall transmit, with parental permission, child-specific information (e.g., current IFSP), recent assessment findings, and other pertinent records to the appropriate school division in which the child resides as soon as possible after the notification to the local school division to ensure continuity of services.

B. If the child is found eligible for early intervention services more than 45 days but less than 90 days before (i) the child's third birthday or (ii) April 1 when the child will reach the age of eligibility for special education at the beginning of the upcoming school year, then as soon as possible after eligibility is determined, the service coordinator shall provide the notification required in 12VAC35-225-190 C unless the parent objects to such disclosure.

C. If a child is referred to the local early intervention system less than 45 days before the child's third birthday and that child may be eligible for preschool services under Part B, the service coordinator shall, with parental consent, refer the child to the local school division and Virginia Department of Education, but the local early intervention system shall not be required to conduct an eligibility determination, assessment for service planning, or hold an initial IFSP meeting under these circumstances.

D. The service coordinator shall ensure exit ratings on the child outcome indicators required by the U.S. Department of Education, Office of Special Education Programs are completed prior to discharge from Virginia's early intervention system for all children who had an entry rating and who have been in the early intervention system for six months or longer since their initial IFSP.

1. The exit rating shall be done no more than six months prior to the child's exit from Virginia's early intervention system.

2. Any circumstances that prevent completion of exit ratings shall be documented in a contact note.

E. The service coordinator shall ensure that no early intervention services are provided on or after the child's third birthday.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

Part VI Service Funding and Payment Systems

12VAC35-225-210 Use of Part C funds

A. Funds available under Part C shall be used for the following activities:

1. To implement and maintain a statewide system of early intervention supports and services for children with disabilities and their families;

2. For direct early intervention supports and services for children with disabilities and their families that are not otherwise funded through other public or private sources; and

3. To expand and improve supports and services for children with disabilities and their families that are otherwise available.

B. Federal Part C funds and state general funds designated for early intervention services under Part C shall be used as the payor of last resort and shall not be used to satisfy a financial commitment for supports and services that would otherwise have been paid for from another public or private source, including any medical program administered by the U.S. Department of Defense, but for the enactment of Part C of the Individuals with Disabilities Education Act.

C. The department and local lead agencies shall identify and coordinate all available resources to pay for early intervention services, including federal, state, local, and private sources.

D. The service coordinator shall coordinate the funding sources for early intervention services in each IFSP.

E. If necessary to prevent a delay in the timely provision of appropriate early intervention services to a child or the child's family, funds available under Part C may be used to pay the provider of early intervention supports and services (excluding medical services) and for functions associated with the child find system, eligibility determination, and assessment for service planning pending reimbursement from the agency or entity that has ultimate responsibility for the payment.

F. The department shall establish an interagency agreement with each participating state agency to ensure the provision of, and establish financial responsibility for, early intervention supports and services; to establish procedures for achieving a timely resolution of intra-agency and interagency disputes about payments for a given service or disputes about other matters related to Virginia's early intervention system; and to ensure that no early intervention supports and services to which a child is entitled are delayed or denied because of disputes between agencies regarding financial or other responsibilities.

G. Local lead agencies shall develop interagency agreements, contracts, or memoranda of agreement with as many early intervention service providers as possible to meet the needs of children with disabilities and their families and shall allow families to have access to any certified early intervention service provider in the family's payor network who agrees to comply with all Part C requirements and is working in the local early intervention system area.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-220 Services provided at public expense

A. The following services shall be provided at public expense and at no cost to families:

1. Child find activities;

2. Eligibility determination and assessment for service planning;

3. Service coordination;

4. Administrative and coordinative activities related to the development, review, and evaluation of IFSPs and interim IFSPs; and

5. Administrative and coordinative activities related to implementation of procedural safeguards and other components of the statewide early intervention system related to child find, eligibility determination, assessment, and development of IFSPs.

B. Localities shall not be required to provide funding for any costs for early intervention services provided at public expense, either directly or through participating local public agencies.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-230 System of payments

A. The department shall establish and implement a system of payments, including a schedule of sliding family fees with monthly caps, for early intervention services provided under Part C. Under that system:

1. Fees shall not be charged to parents for the services a child is otherwise entitled to receive at no cost, including those listed in 12VAC35-225-220;

2. All early intervention services other than those listed in 12VAC35-225-220 shall be subject to family fees;

3. The inability of the parent of a child with a disability to pay for services shall not result in a delay or denial of services to the child or his family, such that if the family meets the criteria for inability to pay, the child shall receive all early intervention services at no cost to the family;

4. Parents shall not be charged any more than the actual cost of services, factoring in any amount received from other payment sources for that service;

5. Charges for early intervention supports and services shall be consistent regardless of the anticipated payment source, and parents with public insurance or benefits or private insurance shall not be charged disproportionately more than parents who do not have public insurance or benefits or private insurance;

6. All parents shall have the opportunity to submit information to establish ability to pay and a monthly cap for family fees. Parents who choose not to provide the required income information shall be charged for all applicable copayments, deductibles, and the full early intervention rate for services not covered by insurance;

7. The service coordinator shall ensure a family's ability to pay is established and consent for use of private insurance, public benefits, or public insurance is determined at intake for children who are covered by Medicaid or FAMIS and for all other children prior to delivering early intervention services other than those services that must be provided at no cost to the family; and

8. A family's ability to pay shall be reviewed at each annual IFSP and any time the family's financial circumstances change. If the family is unable to provide the required information, it shall be charged for all applicable copayments and deductibles or the full early intervention rate for services not covered by insurance.

B. Family fees collected shall be retained by the local lead agency to support the local early intervention system.

C. Parents who wish to contest the imposition of a fee or the determination of the parents' ability to pay may contest such determinations in accordance with 12VAC35-225-380 A.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-240 Use of public benefits or public insurance

A. Parents shall not be required to enroll in public benefits or public insurance programs as a condition of receiving early intervention services, and parental consent shall be required prior to using the public benefits and public insurance of a child or parent if that child or parent is not already enrolled in such a program.

B. Parental consent shall be obtained before the local lead agency or the early intervention service provider discloses, for billing purposes, a child's personally identifiable information to the child's assigned managed care organization, or if the child is not enrolled in managed care, to the Department of Medical Assistance Services.

C. In Virginia, use of a child's or parent's public benefits or public insurance to pay for early intervention services shall not:

1. Decrease available lifetime coverage or any other insured benefit for that child or parent under that program;

2. Result in the child's parents paying for services that would otherwise be covered by the public benefits or public insurance program;

3. Result in any increase in premiums or discontinuation of public benefits or public insurance for that child or his parents; or

4. Risk loss of eligibility for the child or that child's parents for home and community-based waivers based on aggregate health-related expenditures.

D. If the parent gives consent for use of his private insurance to pay for early intervention services for a child who is covered by private insurance and by either public benefits or public insurance, the parent shall be responsible for the costs associated with use of the private insurance, as specified in 12VAC35-225-250 E.

E. If the parent does not provide the consent to use or enroll in public benefits or public insurance or to disclose information to the child's assigned managed care organization, or if the child is not enrolled in managed care, to the Department of Medical Assistance Services for billing purposes, the local lead agency must still make available the early intervention services on the IFSP to which the parent has provided consent.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016; amended, Virginia Register Volume 37, Issue 17, eff. May 28, 2021.

12VAC35-225-250 Use of private insurance

A. The private insurance of a family may not be used to pay for early intervention services unless the parent has provided prior consent.

B. Parental consent to use of private insurance to pay for early intervention services shall be obtained when the local lead agency or early intervention service provider seeks to use the parent's private insurance or benefits to pay for the initial provision of early intervention services and each time there is an increase (in frequency, length, duration, or intensity) in the provision of services in the child's IFSP.

C. The consent requirements in subsections A and B of this section shall also apply when use of private insurance is required prior to use of public benefits or public insurance.

D. If a parent is determined to be unable to pay and does not provide consent for use of private insurance, the lack of consent shall not be used to delay or deny any early intervention services to the child or family.

E. If the parent provides consent for use of the family's private insurance to pay for early intervention services, Part C or other funds may be used to pay for copayment or deductible amounts that exceed the family's monthly cap, unless the family has money in a flexible spending account that automatically pays the early intervention service provider or the family for these costs.

F. Families shall be responsible for paying their insurance premiums.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-260 Written notification

When obtaining parental consent for the provision of early intervention services or for use of public or private insurance or benefits, or both, the service coordinator shall ensure the parents receive written information on Virginia's system of payment policies, which includes the following:

1. Required notification to parents of children covered by Medicaid including:

a. Parental consent requirements in 12VAC35-225-240 B;

b. The cost protections in 12VAC35-225-240 C;

c. The local lead agency responsibility to offer the early intervention services to which the parent has provided consent even if the parent does not provide consent for use of public benefits or public insurance as specified in 12VAC35-225-240 E;

d. The parent's right to withdraw consent for disclosure, for billing purposes, of a child's personally identifiable information to the child's assigned managed care organization, or if the child is not enrolled in managed care, to the Department of Medical Assistance Services at any time; and

e. Categories of costs to parents as specified in 12VAC35-225-240 D;

2. Potential costs to the parent when their private insurance is used, which may include copayments, deductibles, premiums, or other long-term costs such as the loss of benefits because of annual or lifetime health insurance coverage caps under the insurance policy;

3. The payment system and schedule of sliding fees that may be charged to the parents for early intervention services;

4. The basis and amount of payments or fees;

5. Information on the determination of ability to pay and inability to pay, including when and how the determination is made;

6. Assurances regarding fees and service provision as specified in 12VAC35-225-230 A 1, A 3, A 4, and A 5;

7. The policy on failure to provide the required income information as specified in 12VAC35-225-230 A 6;

8. Policies regarding use of federal or state Part C funds to pay for costs such as insurance copayments or deductibles; and

9. Parent rights as specified in 12VAC35-225-230 C.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016; amended, Virginia Register Volume 37, Issue 17, eff. May 28, 2021.

12VAC35-225-270 Billing and collections of family fees, public benefits, and insurance

A. The local lead agency shall ensure billing for and collection of all family fees for the local early intervention system by:

1. Doing all billing and collection of family fees;

2. Contracting with a single entity to bill for and collect all family fees for the local early intervention system; or

3. Assigning the billing and collection of the family fee to a specific early intervention service provider for each child.

B. Early intervention service providers shall routinely, and no less than one time per month, confirm with families whether their insurance has changed and shall notify the local system manager immediately if a child who has or had Medicaid or FAMIS no longer has Medicaid or FAMIS or does not have the Medicaid early intervention benefit and notify the service coordinator if the child had TRICARE or private insurance coverage and the child no longer has that coverage or the child has newly acquired Medicaid or FAMIS, TRICARE, or private insurance coverage.

C. The local system manager, or his designee, shall provide oversight to ensure Medicaid or FAMIS information is correctly entered into the department's early intervention management information system, ITOTS, to begin and maintain enrollment in the Medicaid early intervention benefit.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-280 Provider billing for early intervention services

A. In order to receive reimbursement from federal or state Part C funds as the payor of last resort, early intervention service providers shall:

1. Have a contractual relationship with the local early intervention system; and

2. Submit a contact log or contact notes to the local lead agency no later than the 21st of each month for all services provided in the previous month, including any service for which reimbursement is sought from Part C funds.

B. Early intervention service providers shall accept Medicaid reimbursement for medically necessary early intervention services as payment in full.

C. In order to bill Medicaid for early intervention services other than service coordination, the provider shall:

1. Be certified as an early intervention practitioner;

2. Enroll with the Department of Medical Assistance Services and Medicaid contracted managed care organizations as an early intervention provider;

3. Provide services to children who are determined eligible for early intervention services under Part C;

4. Provide covered services as listed on the child's IFSP and, with the exception of the assessment for service planning and IFSP meetings, services that are approved by a physician, physician's assistant, or nurse practitioner; and

5. Comply with all other applicable Department of Medical Assistance Services requirements.

D. In order to bill Medicaid for service coordination, the provider shall:

1. Be certified as an early intervention case manager;

2. Enroll with the Department of Medical Assistance Services and Medicaid contracted managed care organizations as an early intervention provider;

3. Deliver service coordination in accordance with a signed initial early intervention service coordination plan or a signed individualized family service plan (IFSP);

4. Provide at least one activity during the month being billed to the child, the family, service providers, or other organizations on behalf of the child or family in order to coordinate supports and services and assist the family in accessing needed resources and services;

5. Document the contact or communication completely and correctly in accordance with 12VAC35-225-180;

6. Make a phone, email, text, or face-to-face contact with the family at least one time every three calendar months, or document attempts of such contacts;

7. Ensure documented face-to-face interaction between the service coordinator and the family at the development of the initial IFSP and the annual IFSP along with documentation that the service coordinator observed the child during the calendar month that the IFSP meeting was held;

8. Submit the health status indicator questions to the child's physician every six months; and

9. Comply with all other applicable Department of Medical Assistance Services requirements.

E. Children who are dually enrolled in Virginia's early intervention system and in Medicaid or FAMIS shall receive service coordination under the early intervention targeted case management program.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016; amended, Virginia Register Volume 37, Issue 17, eff. May 28, 2021.

Part VII Procedural Safeguards

12VAC35-225-290 Notice of rights and procedural protections

A. The service coordinator shall provide a written copy and explanation of the child's and family's rights and procedural safeguards at the intake visit and shall provide ongoing information and assistance to the family regarding their rights and procedural safeguards throughout the period of the child's eligibility for early intervention services.

B. The notice and explanation provided at the intake visit shall fully inform parents about the confidentiality requirements under Part C.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-300 Surrogate parent selection

A. A surrogate parent shall be assigned to a child if no parent of the child can be identified, the local system cannot after reasonable efforts locate a parent, or the child is a ward of the state. The service coordinator shall make reasonable efforts to ensure that a surrogate parent is assigned to the child within 30 days after determining the child needs a surrogate parent. In implementing the surrogate parent requirements, if the child is in foster care or a ward of the state, the service coordinator shall consult with the public agency that has been assigned care of the child.

B. The person selected as a surrogate parent shall:

1. Not be an employee of any public agency or early intervention service provider that provides early intervention services, education, care, or other services to the child or any member of the child's family;

2. Have no personal or professional interest that conflicts with the interest of the child he represents; and

3. Have knowledge and skills that ensure adequate representation of the child.

C. A surrogate parent assigned to a child pursuant to this section shall have the same rights as a parent for all purposes in the early intervention system.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-310 Prior written notice

A. Prior written notice shall be given to the parent at least five days before an early intervention provider proposes or refuses to initiate or change identification, eligibility determination, or placement of the child or the provision of early intervention services to the child or family.

B. The prior written notice shall be in sufficient detail to inform the parent of the action being proposed or refused, the reasons for taking the action, and available procedural safeguards, including dispute resolution options.

C. The prior written notice shall be written in language understandable to the general public and shall be provided in the native language of the parent or other mode of communication used by the parent, unless it is clearly not feasible to do so. If the parent does not use a written language, documentation of the procedures used to provide prior notice shall be included in a contact note.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-320 Parental consents

A. Written parental consent shall be obtained prior to (i) performing eligibility determinations and assessments; (ii) providing early intervention services; and (iii) disclosing personally identifiable information to anyone other than authorized representatives, officials, or employees of the department, local lead agency, or early intervention service providers collecting, maintaining, or using information under Part C and using public or private insurance or benefits. When seeking parental consent, the service coordinator shall ensure the following:

1. The parent is fully informed of all information relevant to the activity for which consent is sought, in the parent's native language;

2. The parent understands and agrees in writing to the carrying out of the activity for which consent is sought;

3. The consent form describes that activity and lists the early intervention records (if any) that will be released and to whom they will be released; and

4. The parent understands that the granting of consent is voluntary on the part of the parent and may be revoked at any time and that, if a parent revokes consent, that revocation is not retroactive.

B. The parent shall have the right to accept or decline specific early intervention services identified by the IFSP team and may decline a service after first accepting it without jeopardizing his right to obtain other early intervention services.

C. If a parent does not give consent for eligibility determination, assessment, or provision of early intervention services, the service coordinator shall document reasonable efforts to ensure that the parent is fully aware of the nature of the eligibility determination, assessment, or the services that would be available and understands the child will not be able to receive the eligibility determination, assessment, or services unless consent is given.

D. If a parent refuses to provide consent to disclose personally identifiable information, the service coordinator shall explain to the parent the impact of the parent's decision to refuse consent for the release of information, including why consent is needed, how the information will be used, and how the absence of that information might affect the ability of the child to receive early intervention services. The explanation provided and the parent's final decision regarding consent to disclose the information shall be documented in a contact note.

E. Due process hearing procedures shall not be used to challenge a parent's refusal to provide any consent required under this section.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-330 Early intervention records

A. The local lead agency shall maintain a central early intervention record for each child referred to the local early intervention system. The central early intervention record must include the following:

1. Accurate demographic and referral information;

2. Signed releases and consents;

3. Other completed procedural safeguards forms;

4. A completed and signed initial early intervention service coordination plan if the child has Medicaid or FAMIS;

5. Assessment reports;

6. Medical reports;

7. All other documentation collected during eligibility determination and IFSP development, including reports from previous outside screenings and assessments;

8. Completed eligibility determination forms;

9. All IFSPs developed, including documentation of periodic reviews;

10. Contact logs or contact notes submitted by providers, including service coordinators;

11. Copies of all correspondence to and from the local lead agency or its providers with or on behalf of the family;

12. Court orders related to service provision, custody issues, or parental rights;

13. Documentation of the family's ability to pay, unless it is kept in a separate financial file; and

14. Record access log listings of any individual, except parents and authorized employees, obtaining access to the early intervention record, including the individual's name, date of access, and purpose of access.

B. Each early intervention service provider shall maintain a clinical working file that must include, at a minimum:

1. A copy of the IFSP, including annual and periodic reviews,

2. Contact notes, and

3. Any completed screening or assessment protocols if not housed in the early intervention record.

C. Early intervention service providers working in the provider agency where the central early intervention record is housed shall have the option to maintain the items listed in this section in the central early intervention record instead of in a separate clinical or working file.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-340 Confidentiality of personally identifiable information

A. The department, local lead agencies, and all early intervention service providers shall ensure the confidentiality of personally identifiable information collected, maintained, or used under Part C from the point in time when the child is referred to the local early intervention system until the later of when the provider agency is no longer required to maintain or no longer maintains that information under applicable federal and Virginia laws. Confidentiality shall be maintained at the collection, maintenance, use, storage, disclosure, and destruction stages.

B. One official at each local lead agency and each early intervention service provider shall assume responsibility for ensuring confidentiality of any personally identifiable information.

C. The department, local lead agency, and all early intervention service providers shall train all persons collecting or using personally identifiable information regarding federal and Virginia requirements for safeguarding records and personally identifiable information.

D. Each local lead agency and early intervention service provider shall maintain, for public inspection, a current listing of the names and positions of those employees within the local lead agency and early intervention service provider who have access to personally identifiable information.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-350 Inspection and review of early intervention service records

A. Parents of infants and toddlers who are referred to or receive early intervention services shall have the right to inspect and review all early intervention records collected, maintained, or used by the local lead agency or early intervention service providers, including records related to eligibility determination, assessments for service planning, development and implementation of IFSPs, provision of early intervention services, individual complaints involving the child, or any other part of the child's early intervention record.

B. The local lead agency and early intervention service providers shall provide parents, upon request, a list of the types and locations of early intervention records collected, maintained, or used by the local lead agency and early intervention service providers.

C. If any early intervention record includes information on more than one child, the parent has the right to inspect and review only the information relating to his child or to be informed of that specific information.

D. The right to inspect and review records includes the right to:

1. A response from the local lead agency or early intervention service provider to reasonable requests for explanations and interpretations of the early intervention records;

2. Request that the local lead agency or early intervention service provider provide copies of the early intervention records if failure to provide those copies would effectively prevent the parent from exercising the right to inspect and review the records; and

3. Have a representative of their choice inspect and review the records.

E. The local lead agency and early intervention service providers shall comply with a parent's request to inspect and review records without unnecessary delay, before any meeting regarding an IFSP or a due process hearing, and in no case more than 10 days after the request is made.

F. Upon request, the parent shall receive one copy of his child's early intervention record at no cost to the parent. After the parent has received one copy of the child's early intervention record at no cost, the local lead agency or early intervention service provider may charge a fee for additional copies. However, the local lead agency or early intervention service provider shall not charge a fee for additional copies of the child's records if the fee effectively prevents the parent from exercising his right to inspect and review those records. The local lead agency or early intervention service provider shall not charge a fee to search for or to retrieve information and shall provide at no cost to parents a copy of each eligibility determination, assessment, and IFSP as soon as possible after each IFSP meeting.

G. The local lead agency and early intervention service provider shall presume the parent has authority to inspect and review records relating to his child unless the local lead agency or early intervention service provider has been provided documentation that the parent does not have that authority under applicable Virginia laws governing such matters as custody, foster care, guardianship, separation, and divorce.

H. The local lead agency and early intervention service providers shall keep a record of parties obtaining access to early intervention records collected, maintained, or used by the early intervention system unless such access is by the parent or parents or authorized representatives and employees of the participating agency. The record of access shall include the name of the party accessing the record, the date access was given, and the purpose for which the party is authorized to use the early intervention record.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-360 Request to amend information in the early intervention record

A. A parent who believes that information in the early intervention records collected, maintained, or used in the early intervention system is inaccurate, misleading, or violates the privacy or other rights of the child or parent shall have the right to request that the agency that maintains the information amend the information.

B. When a parent requests that information in a record be amended, the local lead agency or early intervention service provider shall decide whether to amend the information in accordance with the request within a reasonable period of time after the request is received.

C. If the local lead agency or early intervention service provider refuses to amend the information in accordance with the request, the local lead agency or early intervention service provider shall inform the parent of the refusal and advise the parent of the right to a local hearing to challenge the information in his child's early intervention record.

1. A hearing shall be held within 30 days after the request is received by the local lead agency or early intervention service provider from the parent.

2. The parent shall be given written notice of the date, place, and time of the hearing at least 15 days before the hearing.

3. The hearing may be conducted by any person, including an official of the local lead agency or early intervention service provider, who does not have a direct interest in the outcome of the hearing.

4. The local lead agency or early intervention service provider shall give the parent a full and fair opportunity to present evidence relevant to the issues raised. The parent may, at his own expense, be assisted or represented by persons of his own choice, including an attorney.

5. The local lead agency or early intervention service provider shall issue its decision in writing to the parent within five business days after the conclusion of the hearing.

6. The decision of the local lead agency or early intervention service provider shall be based solely on the evidence presented at the hearing and shall include a summary of the evidence and the reasons for the decision.

7. If the hearing determines that the information is inaccurate, misleading, or in violation of the privacy or other rights of the child or parent, the local lead agency or early intervention service provider shall amend the information accordingly and inform the parent in writing.

8. If the hearing determines that the information is accurate, not misleading, and not in violation of the privacy or other rights of the child or parent, the local lead agency or early intervention service provider shall inform the parent of the right to place in the early intervention record a statement commenting on the information or setting forth any reasons for disagreeing with the decision of the local lead agency or early intervention service provider. Any such explanation placed in the early intervention record shall be maintained as part of the early intervention record as long as the record or contested portion is maintained by the agency. If the early intervention record or the contested portion of the record is disclosed by the local lead agency or early intervention service provider to any party, the explanation shall also be disclosed to the party.

D. If the parent is not satisfied with the local hearing determination, the local lead agency or early intervention service provider shall advise the parent of his right to file a due process complaint with the department.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-370 Maintenance of early intervention service records

A. The local lead agency and early intervention service providers shall inform the parent when personally identifiable information collected, maintained, or used in the early intervention system is no longer needed to provide services to the child and shall destroy the information at the request of the parent.

B. A child's early intervention record shall be destroyed at the request of his parent. However, a permanent record of a child's name, date of birth, parent contact information, including address and phone number, names of service coordinator or coordinators, early intervention service provider or providers, and exit data, including year and age upon exit and any programs entered into upon exiting, may be maintained without time limitation.

C. The local lead agency and early intervention service providers shall ensure early intervention records are maintained for a minimum of three years following the child's discharge from the local early intervention system.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

Part VIII Dispute Resolution

12VAC35-225-380 Notification of complaint resolution options

A. The department shall ensure the availability of procedures for resolving complaints through mediation, an administrative complaint, or a due process hearing.

B. The service coordinator shall inform the child's parent of all options for resolving complaints by providing written and verbal information that explains the options and the procedures for each and shall provide the parent with a contact at the department who can assist the parent in filing a complaint.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-390 Mediation

A. Mediation shall be voluntary on the part of all parties; shall be available at any time to parties to disputes involving any matter under Part C, including matters arising prior to the filing of a due process complaint; and shall not be used to delay or deny a parent's right to a due process hearing.

B. The department shall maintain a list of individuals who are qualified mediators and knowledgeable in laws and regulations relating to the provision of early intervention services and shall select mediators on a random or rotational basis.

C. An individual who serves as a mediator shall not be an employee of the department, a local lead agency, or an early intervention service provider that is involved in the provision of early intervention services or other services to the child and shall not have a personal or professional interest that conflicts with the person's objectivity. A person who otherwise qualifies as a mediator shall not be considered an employee of the department, a local lead agency, or an early intervention provider solely because he is paid by the agency to serve as a mediator.

D. The department shall appoint a trained and impartial mediator within five days of receiving the request for mediation.

E. Each session in mediation shall be scheduled in a timely manner and shall be held in a location that is convenient to the parties involved in the dispute.

F. Mediation, including a written mediation agreement reflecting agreements reached by the parties to the dispute, shall be completed within 15 calendar days of the receipt by the department of notice that both parties have agreed to mediation. If resolution is not reached within 15 days, the department shall inform the parents in writing that they may request a due process hearing.

G. Extensions of the 15-day timeline may be granted for good cause. If there is a simultaneous request for mediation and a due process hearing, an extension shall not result in a violation of the 30-day timeline for completion of the due process hearing.

H. If the parties resolve the dispute through the mediation process, the parties shall execute a legally binding agreement that sets forth the resolution, states that all discussions that occurred during the mediation process are confidential and may not be used as evidence in any subsequent due process or civil proceeding, and is signed by both the parent and a representative of the local lead agency or early intervention service provider who has the authority to bind that agency.

I. The department shall bear the full cost of the mediation process.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-400 Due process hearing

A. Due process hearings shall be available to the parent of any child referred to the local early intervention system to resolve complaints regarding an early intervention provider's proposal or refusal to initiate or change his child's identification, eligibility determination, or placement or to the provision of early intervention services to the child or family.

B. The department shall arrange for the appointment of an impartial hearing officer within five days following receipt of a request for a due process hearing. The due process hearing officer shall:

1. Not be an employee of the department, a local lead agency, or an early intervention service provider involved in the provision of early intervention services or the care of the child. A person who is otherwise qualified shall not be considered an employee of the department, a local lead agency, or an early intervention provider solely because he is paid by the agency to implement the due process hearing procedures;

2. Not have a personal or professional interest that conflicts with his objectivity in implementing the process;

3. Have knowledge about the provisions under Part C and the needs of and early intervention services available for children with disabilities and their families;

4. Listen to the presentation of relevant viewpoints about the due process complaint;

5. Examine information relevant to the issues;

6. Seek to reach a timely resolution of the due process complaint; and

7. Provide a record of the proceedings, including a written decision.

C. The due process hearing shall be carried out at a time and place that is reasonably convenient for the parent.

D. Any parent involved in a due process hearing shall have the right to:

1. Be accompanied and advised by counsel and by individuals with special knowledge or training with respect to early intervention services for children with disabilities;

2. Present evidence and confront, cross-examine, and compel the attendance of witnesses;

3. Prohibit the introduction of any evidence at the hearing that has not been disclosed to the parent at least five days before the hearing;

4. Obtain a written or electronic verbatim transcript of the hearing at no cost to the family; and

5. Receive a written copy of the findings of fact and decisions at no cost to the parent.

E. The due process hearing shall be conducted and a written decision shall be mailed to all parties within 30 days of receipt by the department of the parent's request for a due process hearing. The hearing officer may grant a specific extension of the timeline at the request of either party.

F. Any party aggrieved by the findings and decision issued pursuant to a due process hearing shall have the right to bring a civil action in Virginia or federal court.

G. During the pendency of any proceeding involving a due process complaint, unless the local lead agency and the parent of the child agree otherwise, the child shall continue to receive the appropriate early intervention services in the setting identified in the IFSP for which the parent has provided consent. If the due process complaint involves an application for initial services, the child shall receive those services that are not in dispute.

H. Costs for due process hearings shall be equally shared by the local lead agency and the department. The costs shared include expenses of the hearing officer (i.e., time, travel, secretarial, postal, and telephone expenses), expenses incurred by order of the hearing officer (i.e., independent educational evaluations, deposition, or transcript), and expenses for making a record of a hearing (i.e., hearing tapes).

I. The department shall not be responsible for expenses incurred for witnesses, except where hearing officers subpoena witnesses on their own initiative, or for the parent's attorney fees.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-410 Administrative complaint

A. An individual or organization, including those from another state, shall have the right to file an administrative complaint with the department alleging that the local lead agency, an early intervention service provider, or participating agency has violated a requirement of Part C.

B. The department shall widely disseminate to parents and other interested individuals, including parent training and information centers, protection and advocacy agencies, and other appropriate entities the procedures for filing and resolving administrative complaints.

C. An administrative complaint shall be made in writing to the department, allege a violation that occurred not more than one year prior to the date the complaint is received by the department, and include the following:

1. A statement that the department, local lead agency, or early intervention service provider has violated a requirement of Part C;

2. The facts on which the statement is based;

3. The signature and contact information for the complainant; and

4. If alleging violations with respect to a specific child, (i) the name and address of the child; (ii) the name of the early intervention service provider serving the child; (iii) a description of the problem, including facts related to the problem; and (iv) a proposed resolution to the problem to the extent known and available to the complainant if there is one at the time the complaint is filed.

D. The party filing the complaint shall forward a copy of the complaint to the local lead agency or the early intervention service provider serving the child at the same time the party files the complaint with the department.

E. Within 60 days after a complaint is received, the department shall:

1. Carry out an independent onsite investigation, if the department determines that an investigation is necessary;

2. Give the complainant the opportunity to submit additional information, either orally or in writing, about the allegations in the complaint;

3. Provide the local lead agency, other participating agency, or early intervention service provider with an opportunity to respond to the complaint within 10 days by providing a proposal to resolve the complaint and an opportunity to voluntarily engage in mediation;

4. Review all relevant information and make an independent determination as to whether the local lead agency, other participating agency, or early intervention service provider is violating a requirement of Part C; and

5. Issue a written decision to the complainant that addresses each allegation in the complaint and contains findings of fact and conclusions and the reasons for the final decision.

The final decision may include recommendations for technical assistance, negotiations, and corrective actions to achieve compliance, as well as timelines for completion.

If, in resolving an administrative complaint, the department finds a failure to provide appropriate early intervention services then the final decision shall address the corrective actions appropriate to address the needs of the child who is the subject of the complaint and his family, such as compensatory services or monetary reimbursement, and appropriate future provision of services for all children with disabilities and their families.

F. The 60-day timeline for resolving an administrative complaint may be extended only if exceptional circumstances exist with respect to a particular complaint or the parent (or individual or organization) and the local lead agency, other participating agency, or early intervention service provider involved in the complaint agree to extend the timeline to engage in mediation.

G. If the administrative complaint received by the department is also the subject of a due process hearing or contains multiple issues of which one or more are part of that due process hearing, the department shall set aside any part of the complaint that is being addressed in the due process hearing until the conclusion of the hearing. Any issue in the complaint that is not part of the due process hearing shall be resolved using the 60-day time limit and the administrative complaint procedures.

H. If an issue is raised in a complaint that has previously been decided in a due process hearing involving the same parties, the hearing decision shall be binding, and the department shall inform the complainant to that effect.

I. A complaint alleging the local lead agency's, other participating agency's, or early intervention service provider's failure to implement a due process hearing decision shall be resolved by the department.

J. A final decision of the department pursuant to this section shall be a final case decision that may be appealed pursuant to the Virginia Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-420 Appeal to the Department of Medical Assistance Services

A. In addition to the dispute resolution options described in this chapter, Medicaid or FAMIS recipients seeking to contest service decisions shall have the right to file an appeal with the Department of Medical Assistance Services pursuant to federal and state Medicaid law. If the individual is enrolled in a Medicaid managed care organization or "MCO," the internal appeal process for the Medicaid MCO must be exhausted or deemed exhausted before appealing to the Department of Medical Assistance Services. Appeals to the Department of Medical Assistance Services are separate from the dispute resolution options available under this chapter and shall comply with applicable Department of Medical Assistance Services' regulations.

B. A notice of action meeting federal and state requirements must be issued to the individual explaining the basis for the action and the right to appeal.

C. Families shall follow all applicable Department of Medical Assistance Services requirements when filing an appeal.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016; amended, Virginia Register Volume 37, Issue 17, eff. May 28, 2021.

Part IX Early Intervention Practitioner Certification Requirements

12VAC35-225-430 Certification required for early intervention professionals and early intervention specialists

A. Individual practitioners of early intervention services, with the exception of physicians, audiologists, and registered dietitians, shall be certified by the department as early intervention professionals or early intervention specialists.

B. Certified early intervention professionals shall have expertise in a discipline trained to enhance the development of children with a disability, as evidenced by state licensure, including application for state licensure if the discipline authorizes practice in Virginia while the application is pending and the individual practitioner meets all applicable requirements for such practice; state endorsement; or certification by a national professional organization. Qualified personnel in the following disciplines may seek certification from the department as early intervention professionals:

1. Child life specialists certified by the Association of Child Life Professionals, Child Life Certification Commission;

2. Counselors.

a. Licensed professional counselors licensed by the Virginia Board of Counseling; and

b. School counselors (Pre K - 12) endorsed by the Virginia Board of Education;

3. Behavior analysts licensed by the Virginia Board of Medicine;

4. Educators.

a. Educators licensed by the Virginia Board of Education with endorsement in Special Education - Early Childhood (Birth - 5);

b. Educators licensed by the Virginia Board of Education with endorsement in Early/Primary Education (Pre K - 3 or NK - 4);

c. Educators licensed by the Virginia Board of Education with endorsement in Elementary Education (Pre K - 6);

d. Educators licensed by the Virginia Board of Education with endorsement in Career and Technical Education - Family and Consumer Services;

e. Educators licensed by the Virginia Board of Education with endorsement in Special Education - Hearing Impairments (Pre K - 12);

f. Educators licensed by the Virginia Board of Education with endorsement in Special Education - Visual Impairments (Pre K - 12);

g. Educators with a technical professional license issued by the Virginia Board of Education in Career and Technical Education - Family and Consumer Sciences;

h. Educators licensed by the Virginia Board of Education with Endorsement in adapted curriculum K - 12;

i. Educators licensed by the Virginia Board of Education with Endorsement in general curriculum K - 12; and

j. Educators licensed by the Virginia Board of Education with endorsement in English as a Second Language;

5. Family and consumer science professionals certified through the American Association of Family and Consumer Sciences (AAFCS). Individuals certified by the AAFCS after June 30, 2009, shall meet certification requirements in family and consumer sciences - human development and family studies;

6. Marriage and family therapists licensed by the Virginia Board of Counseling;

7. Music therapists certified by the Certification Board for Music Therapists (CBMT);

8. Nurses.

a. Nurse practitioners licensed by the Virginia Board of Nursing; and

b. Registered nurses licensed by the Virginia Board of Nursing;

9. Occupational therapists licensed by the Virginia Board of Medicine;

10. Orientation and mobility specialists certified by the National Blindness Professional Certification Board as a National Orientation and Mobility Certificant (NOMC) or certified by the Academy for Certification of Vision Rehabilitation and Education Professionals (ACVREP) as a Certified Orientation and Mobility Specialist (COMS);

11. Physical therapists licensed by the Virginia Board of Physical Therapy;

12. Physicians licensed in medicine or osteopathic medicine by the Virginia Board of Medicine;

13. Psychologists.

a. Applied psychologists licensed by the Virginia Board of Psychology;

b. Clinical psychologists licensed by the Virginia Board of Psychology; and

c. School psychologists licensed by the Virginia State Board of Education with an endorsement in school psychology;

14. Social workers.

a. Licensed clinical social workers licensed by the Virginia Board of Social Work; and

b. School social workers licensed by the Virginia State Board of Education with an endorsement as a school social worker;

15. Speech-language pathologists licensed by the Virginia Board of Audiology and Speech-Language Pathology; and

16. Therapeutic recreation specialists certified by the National Council on Therapeutic Recreation.

C. Certified early intervention specialists shall hold a minimum of a high school diploma or general equivalency diploma. Qualified personnel in the following disciplines may seek certification from the department as early intervention specialists:

1. Assistant behavior analysts licensed by the Virginia Board of Medicine.

2. Early intervention assistants whose qualifications have been approved by the Department of Behavioral Health and Developmental Services.

3. Residents in counseling with temporary licensure as a resident in counseling by the Virginia Board of Counseling; residents in psychology with registration of residency in clinical or school psychology by the Virginia Board of Psychology; and supervisees in social work with registration of supervised experience by the Virginia Board of Social Work.

4. Licensed social workers licensed by the Virginia Board of Social Work.

5. Nurses.

a. Certified nurse aides certified by the Virginia Board of Nursing; and

b. Licensed practical nurses licensed by the Virginia Board of Nursing.

6. Occupational therapy assistants licensed by the Virginia Board of Medicine.

7. Physical therapy assistants licensed by the Virginia Board of Physical Therapy.

8. Qualified mental health professionals or qualified mental health professional-trainees approved and registered by the Virginia Board of Counseling.

9. Speech-language pathology assistants meeting the qualifications of, and supervised in accordance with, 18VAC30-21-140.

D. Certified early intervention professionals and certified early intervention specialists shall demonstrate knowledge of early intervention principles and practices, including infant and toddler development, family-centered practice, and multidisciplinary team practice, by successful completion of the early intervention principles and practices online training modules administered by the department. A score of at least 80% accuracy on each module's competency test shall be required for successful completion.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016; amended, Virginia Register Volume 41, Issue 26, eff. September 25, 2025.

12VAC35-225-440 Supervision requirements

A. Certified early intervention professionals providing supervision to other early intervention personnel shall complete the supervision training administered by the department. A score of at least 80% accuracy on the competency test shall be required for successful completion.

B. Certified early intervention specialists shall work under the supervision of a certified early intervention professional who has completed the required supervision training.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-450 Certification required for early intervention service coordinators

A. Individual practitioners who provide service coordination to children enrolled in early intervention services shall be certified by the department as early intervention case managers.

B. Certified early intervention case managers shall hold:

1. A minimum of an undergraduate degree in any of the following fields:

a. Allied health, including rehabilitation counseling, recreation therapy, occupational therapy, physical therapy, or speech or language pathology;

b. Child and family studies;

c. Counseling;

d. Early childhood;

e. Early childhood growth and development;

f. Early childhood special education;

g. Human development;

h. Human services;

i. Nursing;

j. Psychology;

k. Public health;

l. Social work;

m. Special education - hearing impairments;

n. Special education - visual impairments; or

o. Other related field or interdisciplinary studies approved by the department;

2. An associate degree in a related field such as occupational therapy assistant, physical therapy assistant, or nursing; or

3. A high school diploma or general equivalency diploma, or an undergraduate degree in an unrelated field, plus three years' full-time experience, at least 32 hours per week, coordinating direct services to children and families and implementing individual service plans. Direct services address issues related to developmental and physical disabilities, behavioral health or educational needs, or medical conditions. Experience may include supervised internships, practicums, or other field placements.

C. Qualified persons shall demonstrate:

1. Expertise in the provision of service coordination services, as evidenced by successful completion of case management training approved by the department. A score of at least 80% accuracy on the case management training competency test shall be required for successful completion.

2. Knowledge of early intervention principles and practices, including infant and toddler development, family-centered practice and multidisciplinary team practice, by successful completion of the early intervention principles and practices online training modules administered by the department. A score of at least 80% accuracy on each module's competency test shall be required for successful completion.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-460 Initial certification and recertification processes

A. To apply for initial certification as an early intervention professional, early intervention specialist, or early intervention case manager, applicants shall:

1. Obtain the designated early intervention certification application package from the department; and

2. Submit a completed and signed application package to the department with:

a. A signed assurance that the applicant will comply with all federal and state early intervention requirements;

b. Documentation of the applicant's educational credentials, professional certification, licensing, endorsement, or other qualification for the practice of his discipline in the Commonwealth of Virginia; and

c. Documentation of the applicant's successful completion of the training required by the department.

B. Any initial certification granted to a person who has made application for state certification, licensure, endorsement, or other qualification in his discipline and is awaiting licensure shall be valid only as long as that person meets the requirements of his discipline to practice in Virginia.

C. Three-year recertification. At least 30 days prior to the expiration of the practitioner's certification period, the certified early intervention practitioner shall submit an application for recertification to the department. This application shall include:

1. Documentation of the practitioner's continuing professional certification, licensing, endorsement, or other qualification for the practice of his discipline in the Commonwealth of Virginia; and

2. Documentation that the practitioner has successfully completed at least 30 hours of continuing learning activities during the three-year certification period. The continuing learning activities shall address one or more of the following: (i) evidenced-based practices in early intervention services; (ii) changes in federal or state law, regulations, or practice requirements; (iii) topics identified on a personal development plan; (iv) training needed for new responsibilities relating to early intervention services; and (v) training required by the department. For each continuing learning activity, documentation shall include a description of the activity and sponsoring organization, if applicable; the date or dates of training; the number of hours; and a copy of a certificate or verification of attendance, if applicable.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-470 Notice of decision on application for certification or recertification

The department shall provide written notice of the decision on the application for certification or recertification within 30 days of the receipt of a completed application and required documentation.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-480 Early intervention practitioner database

Early intervention practitioners meeting the requirements for certification shall be included in the practitioner database maintained by the department. Early intervention practitioners are responsible for notifying the department of any change that may affect their early intervention certification status or their participation in Virginia's early intervention services system.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-490 Restoration of expired certifications

A. An early intervention practitioner whose early intervention certification has expired may apply to the department for restoration of certification.

B. The department may restore early intervention certification for an early intervention practitioner under the following conditions:

1. The individual's early intervention certification has been lapsed for a period of less than one year; and

2. The early intervention certification:

a. Has lapsed because the early intervention practitioner failed to complete the three-year recertification requirements and the practitioner provides documentation to the department demonstrating (i) he is currently qualified for the practice of his discipline in the Commonwealth of Virginia and (ii) he has completed at least 30 hours of training addressing one or more of the topics specified in 12VAC35-225-460 C 2; or

b. Has lapsed because the early intervention practitioner's discipline-specific qualification expired and the practitioner provides documentation to the department demonstrating that he now holds a current license, certification, endorsement, or other qualification for the practice of his discipline in the Commonwealth of Virginia.

C. The department shall provide written notice of its decision to approve or deny the early intervention practitioner's request for restoration of his early intervention certificate within 30 days after the department receives a completed request and all required documentation.

D. Upon restoration of the practitioner's early intervention certification, the department shall record the active status of the certification in the practitioner database maintained by the department.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-500 Termination of certification

A. The department shall terminate an early intervention practitioner's early intervention certification under the following circumstances:

1. The practitioner's discipline-specific license, certification, or endorsement has been suspended, revoked, or otherwise terminated by the appropriate Virginia health regulatory board or other Virginia entity exercising appropriate authority over the practitioner's discipline-specific license, certification, or endorsement; or

2. The practitioner fails to comply with his signed assurance that he will comply with all federal and state early intervention requirements.

B. The department shall notify the early intervention practitioner in writing of the date of and reason for termination and that the practitioner has been removed from the practitioner database maintained by the department.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-510 Reconsideration of decision to deny or terminate certification

A. In the event that the early intervention practitioner disagrees with the determination to deny or terminate certification, he may request reconsideration from the commissioner. The request shall be made in writing within 30 days of the date of the written notice of denial or termination and may include relevant additional information or documentation to support the request.

B. The commissioner shall review the request for reconsideration and information presented and issue a decision in writing within 30 business days following receipt of the request. The decision of the commissioner shall be a final case decision that may be appealed under the Virginia Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

Part X Comprehensive System of Personnel Development

12VAC35-225-520 Comprehensive system of personnel development requirements

A. The department shall ensure a comprehensive system of personnel development that includes the following:

1. Training of paraprofessionals and the training of primary referral sources with respect to the basic components of early intervention services available in Virginia;

2. Training local lead agencies and early intervention service providers to implement innovative strategies and activities for the recruitment and retention of early intervention service practitioners and service providers;

3. Promoting the preparation of early intervention practitioners and service providers who are fully and appropriately qualified to provide early intervention services; and

4. Training local lead agencies and early intervention practitioners and service providers to coordinate transition services for children with disabilities who are transitioning from the early intervention system under Part C to a preschool program under § 619 of the Individuals with Disabilities Education Act, Head Start, Early Head Start, or another appropriate program.

B. The department shall establish and maintain an integrated training collaborative that includes university faculty, parents, early intervention service providers, and state early intervention professional development specialists to develop and implement professional development opportunities, materials, and resources on evidence-based practices for early intervention practitioners and service providers, families, university students, paraprofessionals, and primary referral sources.

C. The department shall use a variety of mechanisms to ensure awareness about and access to professional development, support, and resources, including statewide conferences and meetings, regional and local training activities, web-based training modules and resources, a written monthly update listing available resources and training, and teleconference and webinar capabilities.

D. The department shall support recruiting and retaining early intervention practitioners and service providers.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

Part XI Lead Agency Oversight Responsibilities

12VAC35-225-530 Lead agency monitoring and supervision

A. The department shall monitor implementation of and enforce the requirements under Part C, make determinations annually about the performance of each local early intervention system, and report annually to the public on the performance of Virginia and of each local early intervention system within 120 days of submitting Virginia's annual performance report to the U.S. Department of Education.

B. The primary focus of monitoring activities shall be on improving early intervention results and functional outcomes for all children with disabilities and their families and ensuring that local early intervention systems meet the requirements under Part C.

C. The department shall use quantifiable indicators and, as needed, qualitative indicators to measure performance in providing early intervention services in natural environments, child find, effective monitoring, the use of mediation, and transition services.

D. The local lead agency and early intervention service providers shall cooperate fully with the department and shall provide all information requested by the department or its designee to monitor local performance and compliance with applicable state and federal regulations.

E. The department shall ensure that when it identifies noncompliance, the noncompliance is corrected as soon as possible and in no case later than one year after the noncompliance was identified.

F. If a local early intervention system is determined to need assistance for two or more consecutive years, need intervention, or need substantial intervention in meeting the requirements under Part C, or if the local early intervention system fails to correct noncompliance within one year of identification, then the department shall enforce the requirements under Part C using one or more enforcement actions that may include the following:

1. Technical assistance;

2. Imposing conditions on the local early intervention system's funding;

3. Requiring the development and implementation of an improvement plan; or

4. Withholding funds in whole or in part.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.

12VAC35-225-540 Data collection and reporting

A. The department shall collect, compile, and report timely, accurate, valid, and reliable data as needed to meet the data collection requirements of the U.S. Department of Education and the Virginia General Assembly.

B. The department shall not report any data that would result in the disclosure of personally identifiable information about individual children.

History

• Statutory Authority: § 2.2-5304 of the Code of Virginia.
• Historical Notes: Derived from Virginia Register Volume 32, Issue 10, eff. February 27, 2016.